Document 6427051

Greater
for the
freedom
I
.
‘4.
-
liac&hisfamily.
Now the hemophiliac
can enjoy
a more
normal
lifestyle
with
much greater
freedom
for himself pj
his family.
The key to this freedom
is
Ko#{228}te#{174}
concentrate.
Whether
at home
or on the
road,
Kote#{174}concentrate
enables the hemophiliac
to treat
himself
quickly,
safely, conveniently.
Ko#{228}te#{174}
concentrate
usually
reconstitutes
in less than five
minutes.
Provides
approximately
250 AHF units per 10 ml
of solution.
Travels
anywhere
without
refrigeration
for up to
six months.
And comes with an
easy-open,
flip-top
plastic
cap.
Just as importantly,
Kote#{174}
concentrate
has low fibrinogen
and minimal
non-AHF
protein
levels, pnMding
the assurances
you need to let him treat himself.
Antihemophilic
Factor
(Human)
self-reliance
forthe
hemophiliac.
See following
page
for summary
of prescribing
information.
This
cufterobg
Division
Berkeley
of Cutter
CA 94710
Laboratories,
One
YVOC
Inc.
#{163}
UIL
iv
BLOOD-THE
Ko at
Factor
A NEW
FROM
(Human)
SEE SECTIONS
ENTITLED
INDICATIONS’
AND
WARNING
FOR
DESCRtPTION
OF HEPATITIS
RISK
THIS PRODUCT
IS PREPARED
FROM
HUMAN
VENOUS
P1ASMA
EACH
INDIVIDUAL.
UNIT
OF PLASMA
AND EACH
lOT OF FINAl.
PROI)UCT
HAS
SEEN
TESTED
BY THE RADIOIMMUNOASSAY
METFK)I)
ANt) FOUND
NONREACTIVE
FOR HEPATITIS
B SURFACE
ANT IGF.N
UNFORTUNATElY,
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ASH
JOURNAL
PERGAMON
Leukemia
Research
Editors:
SVEN-AAGE
of Copenhagen,Denmark
C.N. MULLER-BERAT,
plantation
Laboratory,
KU LLMANN.
and
Leukemia
Denmark
University
and
Trans
maltalaeai’at_a_’altnn_a’antati_a_mlattatn’haia!’aa_n’tm
I ((t at)a(t(tatt(at(
Aims & Scope
LEUKEMIA
RESEARCH
aims to promote
interdisciplinary
confrontation
of high quality
publications
pertinent
to leukemia
and closely
related
diseases
Consequently,
there will be no
restriction
as to the specific
field of Interest
of
the authors,
the methods,
the materials
(human
as well as animal),
the approach
(clInical,
biological
or dealing
with pure basic sciences),
as long as the data are experimental
and of high
standard
Contributions
which
do not deal
directly
with
leukemia,
but deal with
normal
blood
and tissue as well as with cell biology
at
large are highly
welcome
in so far as they carry
a message of general
interest
for the under
standing
of the deranged
mechanisms
of the
biology
of the leukemic
cell.
Such would
be
papers dealing
with differentiation
or molecular
biology
of growth
control
p .adn_qmaatn_
I
an_tnt
Ill
In_an_In_i
recent
and forthcoming
papers
HE. BROXMEYER
etal:
Abnormal
granulocyte
feedback
regulation
of colony
forming
and colony
stimulating
activityproducing
cells from patients
with chronic
myelogenous
leukemia
SloanKettering
Institute
for Cancer
Research,
New
York
Some
A ZEBROWSKI
etal:
Human
B-lymphocyte
antigens
expressed
by lymphocytic
and
myelocytic
leukemia
cells:
lymphocytedependent
antibody
studies with rabbit antisera
University
of California
School
of Medicine,
Los Angeles
Supplied
Hots
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intait
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n_aid
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JOURNAL
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thn_aIla_’aa’anltltia
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len_an_a ian_a hn_aadn_ dtn_gataaaaa. dan_aga
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that
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al naetchn_na’
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labeling
ann_In_ding the
prtnaednaatan_elraanithn_(aanapaaatma
llealaelea
Cn_htharnan_ aallan_n_ In_tan_n_tibet n_tad tan_er al than pa_dun_a attain_a ann_epa
thn_ iasranahea’aaail
References
I kin_In__i
P k
i-i
iii
2.
han_n_ta IA
22)
km!atmn_
Sit)
Smi
lla’ta,ain_ma
tn_al
lnitn
gIn_nit
m_’a(i(a_’aiitta(a’n_
1(72
llaan_ia.a
at n_tann_eaiarn_aed
II
I)heraanaa
aataahentiaphtlia
3.SameleaRA
alit 1aIn_tn_rat n_fail
lIlt
litilati
IA
In_n_tan
572
n_a al Iln_ttaailatmc attn_-nina due
ta n_aaai-A
lian_Paratitait
l3’nl4l,
a
Taaaaafaaatan
Iii
M BACCARI
NI et al: Cell
chemotherapy
with multiple
cytosine
in chronic
myeloid
Orsola
lint
kn’in’a
C ahtntmmmi
a47Ium
Hospital,
Bologna
G. JANOSSY
et al: Comparative
analysis
of
membrane
phenotypes
in acute lymphoid
leukemia
and in lymphoid
blast crisis of chronic
myeloid
leukemia
Membrane
Immunology
Laboratory,
London
subscription
1978 US$50.00
Two year rate 1978/79
US$95.00
Prices include
postage
and insurance
Free specimen
copy on request
Annual
Pergamon
Pergamon
New
York
Pergamon
taanimiatpaattn_tin_n_nn_tuaL
University
flux studies during
doses of arabinosyl
leukemia
Oxford_OX3OBW,
Press
10523,
Press
Inc
Fairvaew
Press
Park,
Elmsford,
USA
Ltd.
Headington
England
Hill
Hall,
194
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BLO
D-THE
JOURNAL
OF
THE
ASH
ix
kN
__
LUMIL\_
___
_
_
ETER
AGGREGOM
measures
secretion
platelet
of ATP
PAP Basehne
oL
-
TYPICAL
PLATELET
AGGREGATION
U
‘L:’::i
- -.
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E_____
The Lumi-Aggregometer
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aggregation
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of ATP
from
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of platelet-
‘-
--
rich-plasma.
-
:
-
#{149}#{149}__
EPINEPHRINE
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09
Baseline
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ADDFD
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Aggregation
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No
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Release
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of ATP is detected
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Both aggregation
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Result? Dramatic
dollar savings.*
Lower
the patient. Double utilization
of donors.
Increased
hospital efficiency.
Ask
for a detaed
savings
analysis
cost to
See the singular
HAEMONETICS#{174} 30 in
operation.
Just write or call toll free
(800) 225-4811.
/
-r
a)
0’
HAEMONETICS
HAEMONETICS
CORPORATION
Erie Drive, Natick, Massachusetts
01760
Disseminated
Breast
Cancer
insitu and
One
of a number
of malignancies
in which
Adriarnycin’
(doxoruLcin
I OR
IlycIrocIik:)IicIe)
for 111ieCi()I1
Ni RAVEN(
it)
In
( )NL
)I ‘S I
nd
So
i
LABORATO9/ES
fOr complete
prescribing
in
\
itk
INC
formation,
please see
the followiiig
page.
Adriamycin
is of importance.
In addition
to advanced
metastatic
cancer of the breast.
other
disseminated
neoplastic
conditions
have responded
to
Ad riamycin
and include:
acute lym phohlastic
leu kent ia.
acute myelohlastic
leukemia.
Wilms’ tumor. osteogen
ic and
soft tissue sarconia.
neurohlastoma.
ovarian
carcinoma.
transitional
cell bladder
carcinoma.
thyroid
carcinoma.
lymphoma
of both Hodgkin’s
and non-Hodgkin’s
type. and
hronchogenic
lung carcinoma
in which the small cell
histologic
type is the most responsive
compared
to other cell
types. Adriamycin
should
he administered
only under the
direction
of specialists
qualifIed
in the administration
of such
drugs.
Severe
local tissue necrosis
will occur if’ there is
extravasation
during
administration.
Severe irreversible
myocard
ial toxicity
with delayed
congestive
failure often unresponsive
to any cardiac
supportive
therapy
may he encountered
as total dosage
approaches
550 mg/m.
This toxicity
ma
occur at lower
cumulative
doses in patients
with prior mediastinal
irradiation
or on concurrent
cyclophospha
ni ide therapy.
The incidence
of hone marrow
depression
is high.
l-Iematopoietic
toxicity may limit dosage.
In patients
with impaired
hepatic
function,
dosage
should
he reduced.
For information
on the use of Adriamycin.
call collect
(302) 575-7830.
Adda Laboratories
ADRIAMYCIN
Inc.
doxoribcin
FOR INTRAVENOUS
hydrochloride)
for ection
USE ONLY
WARNINGS
1. Severe local tissue necrosis will occur if there is exlravasalion
during administration
Adnuamycin must not be given by the intramuscular
or subcutaneous roule
2.
Serious irreversible myocandial toxicity with delayed congestive failure often urwespon
suve to any cardiac supportive therapy may be encountered as total dosage approaches
550 mg/m’
This toxicity may occur at lower cumulative doses in patientu with prior
meuliasfunal irradiation or on concurrenl cyclophosphamide
therapy
3. Dosage should be reduced in patients
4.
Severe myelosuppression
with impaired
hepa9c function
may occur
5. Adnuamycun should be administered
only under the supervision
experuenced in the use of cancer chemotherapeulic
agents
of a physician
who
us
DESCRIPTION
Ooxorubcin
Il/s
var caesius
is a cytoloxic
II
anthracycline
antibiotic
solaled from cuilures of Srrepromyces peuce
is supplied in INn hydrocforide
form as a freeze.dried powder contaimng laciose
CUNICAL PHARMACOLOGY
Though not completely elucidated. iNn mechanism of action of dooorubicin is related to its ability
to bind to DNA and inhibit nucleic acid synthesis Cell culture studies have demonstrated
raod cell
penetration and perinucleoiar chromatin binding. rapid inhibition of mitotic activity and nucleic acid
synthesis
mutagenesis and chromosomal
aberrations
Animal studies have shown activity in a
spectrian of enpenmental tmnses. immunosupession.
carcinogemc properties in rodents induction
of a variety of tonic effects, includmg delayed and progressive cardiac toxicity in rabbits. myelosup
pression in all species and atrophy to testes in rats and dogs
Pharmacokinetic
studies show the intravenous administration
of normal or radiolabeled Adria
mycin ld000rubicin hydrochlorideltor
inectise is followed by rapid plasma clearance and significant
tissue binding Urinary excretion. as determined by fluorimetric
methods, accounts fm appruni
mately 4.5% of the administered dose in five days Biliary excretion represents the mayor encretion
route, 4O5O% of the administered
dose being recovered in the tide se the feces in seven days
Impairment of liver function results in slower excretion. and. consequently, increased retention and
accumulation an plasma and tissues Adriamycin does not cross the blood brain barrier
INDICATIONS
Adriamycin has been used successfully to produce regression in disseminated neopiastic condilions such as acute lymphoblastic
leukemia. acute myelobiastic leukemia, Wifms tumor. neuroblastoma. soft tissue and bone sarcomas breast carcinoma. ovarian carcinoma. transitional ceil bladder
carcinoma. thyroid carcinoma. lymphomas of both Hodgkin and non-Hodgkin types and teonchogenic
carcinoma in which the siall cell histoiogic type is the most responsive compared to other cell
types A number of other Solid tamses have also shown some responsiveness
but in numbers too
limited to lustify specific recommendation
Studies to date have shown mahgnani melanoma. kidney
carcinoma. large bowel carcinoma. brain tumors and metastases to the Central Nervous System not
to be significantly
responsive to Adriamycan therapy
CONTRAINDICATIONS
Adriamycin therapy should not be started an patients wtso have marked myeiosuppressaon anduced
by previous treatment with other antitumor agents or by radiotherapy
Conclusive data are not
available on pre-eoisting
heart disease as a co-factor of increased risk of Adriamycin
induced
cardiac txoicity
Preliminary data suggest that in such cases cardiac toxicity may occur at doses
lower than the recommended cumulative limit it as therefore not recommended to start Adraamycin
in such cases Adruamycin treatment is confraunducated in patients who received previous treatment
with complete cumulative doses of Adruamycun and daunorubucin
WARNINGS
Special attention must be given to the cardiac toxacity euhibated by Adriamycin
Although
uncommon. acute left ventricular failure has occurred. partacularly in patients who have received
total dosage of the drug enceeding the currently recommended
limit of 550 mg/m’
This limit
appears to be lower 1400 mg/m’) in patients who received radiotherapy to the mediastunal area or
concomitant therapy with other potentially cardiotoxic agents such as cyclopitosphamude
The total
dose of Adriamycin administered to the individual patient shouid also take into account a previous or
concomitant therapy with related compounds such as daunorubucin Congestive heart failure and/or
cardiomyopathy
may be encountered several weeks after discontinuation
of Adruamycun therapy
Cardiac failure is often not favorably affected by presently known medical or physical therapy for
cardiac support Early clinical diagnosis of drug induced heart failure appears to be essential for
successful treatment with digitalis, diuretics, low salt diet and bed rest Severe cardiac toxicity may
occur precipitously
wathout antecedent Ef(G changes Baseline EKG and periodic foiiow.op EKG
during, and immediately
after, active drug therapy is an advusabie precaution
Trarosent EKG
changes, such as 1-wave flattening. S-I depression, and arrfrythmuas are presently not considered
indications for suspension of Adriamycin therapy A persistent reduction in the voitage of the 005
wave is presently considered mxre specifically
predictive for cardiac toxicity
If this occurs, the
benefit of continued therapy must be carefully evaluated against the risk of producing irreversible
cardaac damage
There as a high incidence of bone marrow depression, primarily of leukocytes. requiring careful
hematological
monitoring
With the recommended dosage scheduie. ieukopenia is usually transient.
reaching its nadir at 10-14 days after treatment with recovery usually occurring by the 21st day
White blood cell counts as low as 1000/mm’ are to be expected during treatment with appropriate
doses of Adriamycan Red blood cell and platelet levels should also be monitored since they may also
be depressed Hematologic tonucuty may require dose reduction or suspension or delay of Adriamycin
therapy Persistent severe myelosuppressuon may result in superinfectuon or hemorrhage.
It has been reported that Adriamycun may enhance the seventh ‘f the toxicity of anticancer
therapies such as exacerbation
xi cyciophosphamade
induced hemorrhagic
cystitus. mucositis
induced by radiotherapy. arid hepatotoxicuty of 6-mercaptopurune
Toxicity to recommended doses of Adniamycin is enhanced by hepatac impairment, therefore, prior
to the individual dosing, evaluation of hepatic function is recommended using conventional clinical
laboratory tests such as SGOT, SGPT, alkaline pfuosphatase. bulurubun, and BSP. (See Dosage and
Administration)
On intravenous administration
of Adruamycun. a stinging or burning sensation signifies a small
degree of eotravasatuon and even if blood return from aspiration xl the infusion needle us good, the
inecf ion or infusion should be immediately terminated and restarted in another vein
PRECAUTIONS
Initial treatment
with Adnuamycin requires close observation
of the patient and extensive
laboratory monitoring. it is recommended. fhenefore, that patients be hospitalized at least during the
first phase of the treatment
There us no adequate information on whether this drug may advenseiyeffect fertility an huanan
males or femaies. or have a teratogenic potentiai or other adverse effects on the fetus Experimental
teratology studies, though not showing a definite increase in specific or nonspecific malformations
indicate a moderate interference with the viability of embryos and fetuses. Adniamycin has been
shown to be abortufacient when given in high doses to rabbits. Therefore the benefits to the pregnant
patient should be weighed against the potential toxicity to fetus and embryo Adnialrrycin and related
compounds have also been shown to have mutagenic and carcinogenic properties when tested in
experimental models
Like other cytotooic drugs. Adnuamycin may induce hyperunicemia secondary to rapid lysis of
neoplastic cells The clinician should monitor the patient’s blood uric acid level areS be prepared to
use such supportive and pharmacologic measures as might be necessary to control thus problem
Adnuamycun imparts a red coloration to the urine for 1-2 days after administration
and patients
should be advised to expect this during active therapy
Adnuamycun is not an anti-microbial
agent
ADVERSE REACTIONS
Dose limiting toxicities of therapy are myebosuppressaon and cardiotoxicuty (see Warnungs( Other
reactions reported are’
Cutaneous.
Reversible complete alopecua occurs in most cases Hyperpugmentatuon of nailbeds
and dermal creases, primarily, occurs in children in a few cases Recall of skin reaction due to prior
radiotherapy has occurred with Adnuamycun administration
Gastrointestinal
- Acute nausea and vomutang occurs frequently and may be severe Thus may be
alleviated by antuemetic therapy Mucosutus (stomatitis and esophagutus) may occur 5-10 days after
administration
The effect may be severe leading to ulceration and represent a site of origin for
severe infections The incidence and severity of mucosuf us is greater with the 3 successive daily
dosage regimen Anorexia and diarrhea have been occasionally reported
Vascular - Pfsiebosclerosus has been reported especuaify when small veins are used or a single
vein is used for repeated administration
Facial fluahing may occur at the unectuon is given too
rapidly
- Severe celluluf us. vesicatuon and tissue necrosis will occur if Adniamycun is eolravasated
during administration
Erythematous streaking along the vein proximal to the site of the unlectaxn has
been reported
Hypersensitivity
- Fever, chills and orticania have been reported occasionally
Anaphylaxus may
occur A case of apparenf cross sensitivity to lancomycun has been reported
QIIie- Conlunctuvutis and lacnumatuon occur rarely
DOSAGE AND ADMINISTRATION
Care in the administration
of Adnuamycun will reduce the chance of perivenous infiltration
It may
also decrease the chance of local reaction such as orticaraa and erythematous
streaking
The recommended dosage schedule is 6075 mg/m’ as a single intravenous unlectuon administered
at 21-day intervals
The lower dose should be given to patients with inadequate marrow reserves
due to old age, or prior therapy. or neoplastic marrow infiltration
An alternative dose schedule us 30
mg ‘m’ on each of three successive days repeated every 4 weeks Adnuamycun dosage must be
reduced at hepatac function is impaired according to the following table
Serom Bilirubun
L
Levels
12-30mg
%
3 mg %
BSP
Retention
9-15%
. 15%
Recommended
Dose
normal dose
‘normai
dose
‘u
Preparation of Solution Adniamycun 10 mg vials and 50 mg vials should be reconstituted
with
Sodium Chloride Iniectuon U SP 5 ml and 25 ml respectively, to give a final concentration of 2 mg/mI
of doxorutuucin hydrochloride
Both powder and solution must be handled with care If Adniamycin powder or solution contacts
the skin or mucosae. wash thoroughly with soap and water
After adding the duluent, the vial should be shaken and the contents allowed to dissolve The
reconstituted
solution is stable for 24 hours at room temperature and 48 hours under refnugeratuon
(4-10CC) It should be protected from exposure to sunlight and any unused solution should be
discarded
It is recommended that Adnuamycun be slowly administered into the tubing of a freely runnang
intravenous infusion of Sodium Chloride Injection US P or 5% Dextrose Injection US P The tubing
should be attached to a Butterfly
needle inserted preferably into a large vein The rate of
administration
is dependent on the size of the vein and the dosage However the dose should be
administered in not less than 3to 5 minutes. Local eryfhemalous streaking along the vein as well as
facial flushing may be undicafuve of too rapid an administration
A burning or stinging sensation may
be indicative of perivenous infiltration
and the infusion should be ummedaately terminated
and
restarted in another vein
Adniamycin ohould not be mixed with heparun since it has been reported that these drugs are
incompatible
lx the extent that a precipEfate may form Until specific compatibility
data are
available, it us not recommended that Adniamycin be mixed with other drugs
Adnuamycin has been used in combination with other approved chemolhenapeutic
agents Though
evidence us available that at least in some types of neoplastic disease combinalion chemotherapy us
superior to single agents, the benefits and risks of such therapy have not yet been fully elucidated
HOW SUPPLIED
ADRIAMYCIN “(doxorubicin
hydrochlonide)for
Injection is available in two sizes
10mg - Each rubber disc-capped vial contains 10 mg of doooriEacin HCI and 50 mg
U S P as a sterile red.orange
lyophiluzed powder Packaged and supplied
cartons NDC 38242874-1O.
50mg - Each rubber disc-capped vial contains 50 trig of doxorubicin HCI and 250 req
US P as a sterile nedorange lyophilized powder Pachaged and supplied in a
carton NDC 38242-875-50
03701A
M8740102-1A
TM
rriiti
Manufactured
Distributed by Adnua Laboratorues
1105 Market Street
Wilmington. Delaware 19899
by Farmutalua SpA, Italy.
of lactose
in 10-vial
of lactose
single vial
80076
The
What
Differential
gives
advanced
Classifier
you an
differential.
The ADC-500
advantages.
Like the routine
increased
It reduces
different/al
as 55% as compared
differential.
An exam more than a test.
500 cells per sample.
Up to 40 samples
per hour.
All with walk-away
automation.
The ADC-500
has high-resolution
scanning.
solid-state
electro-optics,
high-speed
computers
and simultaneous
multicolor
analysis
capability.
That’s why we say its differentials
are more like
blood exams
than blood
As the system’s
studies
tests.
high-resolution
microscope
each slide, the cell scene is observed
scanned
scanning
by the three
arrays.
photo-sensitive
statistical
and
Also. the
normal white
of abnormals.
Review Mode,
abnormals
for
differential
for
and precision
sampling
error
to the standard
by as much
100 ce/l
performs
platelet
per hour
What’s more. the ADC-500
performs
all its
functions
automatically.
Once the RUN button is
pushed.
the operator
can simply walk away.
solid-state
and shape,
blood
Sophisticated
500-cell
accuracy
of Important
In addition,
the system automatically
red blood cell morphology
and estimates
sufficiency,
processing
up to 40 samples
Be sure
and cytoplasmic
you a variety
ADC-500
routinely
identifies
six
blood cell types and three groupings
plus nucleated
red cells And in its
it will call up additional
classes of
operator
verification.
With special color filters, these arrays extract
information
from each scene and then feed it to a
hard wired data pre-processor.
The pre-processor
condenses
these data into measurements
of familiar
cell characteristics
such as cell size, nuclear
size
nuclear
can do
it
offers
color.
system
The high-speed
computer
then comes
play. It has already been “trained” and
into
programmed
to generate
its own histograms
from large numbers
and varieties
of cell
classes.
When asked to identify a cell, all it has
to do is compare
the pre-processor’s
histograms
with its own. (And that it does
in 60 milliseconds!)
All of this should give you an idea of
how sophisticated
a system the ADC-500
is. And also help you to understand
why it has the accuracy
and the
precision
and the speed and the
capability
that it does.
write
For further
to: Manager
a
to put
exam
our
to the
information
Hematology
Abbott
test
soon.
on the ADC-500
Systems.
Laboratories
Diagnostics
Division
4757 Irving Boulevard
Dallas, Texas 75247
FEATURING
.
Rapid,
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#{149}
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RIA
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STEPI
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patient sample or
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STEP3
Add
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BLOOD-THE
Xviii
JOURNAL
OF THE ASH
Available
as a special
supplement
to BLOOD
All
abstracts
Meeting
submitted
of the
December
The
has been
Society
provided
to registrants
who
desire
$6.25
per
GRUNE
FIFTH
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Supplement
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AVENUE,
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charge.
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INC.
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a copy,
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sent
of Hematology,
For non-members
111
American
the
1977
Supplement
American
for
meeting
be ordered
and
at
You are
atthe
a thrombus.
Time required: 72
hOUrS
or less.
of
Introducing the first thrombolync
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a newalternativeto
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thrombectomy.
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To lyse venous
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Streptase#{174}
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Anticoagulant therapy
Is given
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able
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Thrombosis
and thrombolysis information
available
thrombosis,
complete
Streptase
produced
or significant
clearing
of
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in 54%
of patients
while
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showed
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When
scribing
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In patients
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that
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New
purified
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/3-hemolytic
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is the
In studies
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of streptokinase,
a
derived from
streptococci.
It com-
patients
embolism,
with
was seen in
patients
on Streptase
11 % of the heparin-
Table I
Comparative
angiographic
results
controlled
investigations*
V.....
Snepto..
137 potue,,tsl
COmplete
by angiography:
Sjgnificant,
but incomplete,
in patients
ciearing
No
change
Worse
controlled
with
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most
the
incidence
important
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and
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ulation
syringe
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pump
22%
P,h,.o,wy
H.po6n
141 p.ti.nts)
5%
E,.b.b...
Stmpt...
(36
p.iumt.l
22%
Hp6,
(88
p.tu..tsi
5%
2%
44%
6%
21%
20%
20%
43%
22%
66%
14%
35%
3%
7%
0%
11%
Data on file and available
on request from HoechstRoussel Pharmaceuticals
Incorporated.
Pulmonary
embolism
data include those taken from National
Heart
and Lung Institutestudy.
with
coag-
and volumetric
administration
pre-
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that includes
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In most cases, clearance
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For best results, Streptase
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In comparative
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Hoechst-Roussel
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graphs,
residual
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quent
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severity
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and dosage information,
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for Streptase,
a summary
of which appears
on the following
page.
HOECHST-ROU8SEI.
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PHARMACEUTCALS
SOMERvuLl.E,
NEW
iNCOORATED
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or
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Patients with known
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should be terminated
and
symptomatic
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employed.
Other mild allergic
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are not serious enough to require discontinuation
of
changes
Brief Summary
of the Prescribing
Information
Streptase#{176} (streptokinase)
should only be used by physicians with
wide experience
in the management of thrombotic disease in hospitals
where
the recommended
clinical and laboratory monitoring
can be performed.
The full prescribing information should be read
for complete details.
When considering
treatment
with Streptase
(streptokinase)
the
overall clinical status and history of the patient should be carefully
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The hemostatic capability
of the patient is more pro
foundly
altered
and bleeding
more frequent
with Streptase
(streptokinase) therapy than with heparin or oral coumarin compound
anticoagulant
therapy. When bleeding occurs it is also more severe
and more difficult to manage. The potential risk of serious hemorrhage relative to such factors as age, physical condition, and underlying bleeding tendency of the patient should be weighed
against the potential benefits of treating the patient with
Streptase’
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Indications
five
days
after
onset.
Reduction
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has
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Deep
Vein Thmmbosis:
Streptase’
(streptokinase)
is indicated
for
lysis of acute, extensive
thrombi
of the deep veins in adults.
Diagnosis should be confirmed
by oblective
methods.
Streptase’
(streptokinase)
should be administered
as soon as
possible after the onset of the thrombotuc
event (preferably
within
several days), although
slight enhancement
of clot lysus has been
shown
Use of Antucoagulants:
Concurrent
use of anticoagulants
with
Streptase’
(streptokinase)
is not recommended
and may be
hazardous.
A thrombin
time of less than twice the normal control
value us adequate
for starting
Streptase’
Istreptokinase)
infusions
safely
following
the use of heparin. Heparin should not be started
following
Streptase
(streptokunase)
therapy until the thrombun
time has returned
to less than twice the normal control value.
In order to minimize
rethrombosis,
the use of intravenous
heparin followed
by oral anticoagulant
therapy is considered
a necessary adjunct
following
Streptase’
(streptokunase)
therapy.
Use in Pregnancy
and in Children:
Streptase’
(streptokinase)
therapy during pregnancy
and in children
is not recommended.
Precautions
Pulmonary
Embolism:
Streptase
(streptokinase)
is indicated
in
adults for the iysis of acute massive pulmonary
emboli,
defined as
obstruction
or significant
filling detects involving
two or more iobar
pulmonary
arteries or an equivalent
amount of emboli in other yessels. It may also be undicated
for emboiization
accompanied
by
unstable
hemodynamics.
The diagnosis
should be confirmed
by ob.
lectuve
means.
Streptase’
(streptokinase)
treatment
should be instututed as soon as possibie after onset of symptoms
and no later
than
therapy.
with
inutiatuon
of therapy
up to two
weeks
after
the
onset
of
symptoms.
Contraindications
Predisposition
to Bleeding:
Because
thromboiytic
therapy
increases
the risk of bleeding,
Streptase’
(streptokinase(
is contrainducated
when the following
conditions
exist: surgery within 10 days, iiver or
kidney biopsy within 10 days, intraarteriai
diagnostic
procedure
within 10 days, ulcerative
wound, recent trauma,
visceral carcinoma,
parturition
(within
10 days), ulcerative
colitis or diverticulitis,
hypertension,
liver or kidney disease, thrombocytopenia
or other evidence
of defective
hemostasis,
active tuberculosis,
subacute
bacterial
endocarditis,
gastrointestinal
bleeding
within
6 months.
Predisposition
to Allergy:
Streptase*
(streptokinase)
is contraundicated in patients
with a history of a previous severe allergic
reaction to Streptase’
(streptokinase)
or who present a significant
risk
of an allergic response.
Recent Cerebral Embolism,
Thrombosis,
or Hemorrhage:
Treatment
with Streptase’
(streptokinase)
is contraindicated
for at least two
months.
Predisposition
to Systemic
Infection:
Use of Streptase’
(streptokunase) in septic thrombophlebitis
may be hazardous
because of
the risk of inducing
systemic
infection.
Warnings
Bleeding: Activation of the fibrinolytic
system with Streptase#{176}
(streptolcinase)
results in a more profound
alteration of the hemostatic status of the patient than does anticoagulant
therapy. Although the aim of Streptase’ (streptokinase) therapy is the production of sufficient amounts of plasmin for lysis of intravascular
deposits of fibrin, other fibrin deposits are also destined for lysis and
bleeding
may result. The possibility of bruising or hematoma
formation especially with intramuscular
injections
is high.
Bleeding at sites of recent invasive procedures
may occur.
Should an arterial puncture
be absolutely
necessary,
the femoral
artery must be avoided and the radial or brachial
artery used. Also,
invasive venous procedures
should be performed
as carefully
and
infrequently
as possible.
If the
bleeding
from
an
invasive
site
us
not serious,
treatment
may be continued
with appropriate
clinical
observations.
Spontaneous
bleeding
from internal
sites may also occur.
Should serious spontaneous
bleeding
occur, the infusion
of
Streptase’
(streptokinase)
should be terminated
immediately.
In addition
to its fibrinolytic
action,
piasmin
also degrades f Ibrunogen, Factor V. Factor VIII, and other proteins.
These products
possess an anticoagulant
effect and should be monitored
by serial
thrombun
time determinations.
Predisposition
to Cerebral Embolism:
Treatment
with Streptase’
(streptokinase)
of patients
with conditions
in which there is possible risk of cerebral
embolism
may be hazardous
because of the
risk of bleeding
into the infarcted
area.
Allergy:
Streptase’
(streptokinase)
us antigenic,
thus, allergic
reactions including
anaphylaxis
may occur.
Recipients
of Streptase’
(streptokunase)
should
be observed
If the patient’s
tance,
the
history
gives
streptokunase
mine the proper
1,000,000
lU.
be administered.
Streptase’
test
loading dose. When
are found, Streptase’
(streptokinase)
altered platelet
tiate this effect
rise to suspicion
resistance
of elevated
should
be used
resistance
levels
(streptokinase)
infusions
have
function.
Concurrent
should be avoided.
been
use of drugs
resusto deter-
in excess of
should not
associated
that
with
may poten-
Adverse Reactions
Incidence
and
Management
Bleeding:
Severe spontaneous
bleeding has been documented
of 292 patients during Streptase’
(streptokinase)
treatment.
eral fatalities
due to cerebral
hemorrhage
Streptase’
(streptokunasel
therapy.
Less
ing has been observed
during
Streptase’
at approximately
heparin therapy.
been
traced
twice the frequency
In several instances,
to concomitant
in 6
5ev-
have occurred
during
severe
spontaneous
bleed(streptokunase)
treatment
as that occurring
during
spontaneous
bleeding
has
anticoagulant
treatment
which
is not
recommended.
Management
of Severe Bleeding:
Streptase’
(streptokinase)
therapy must be discontinued.
If very rapid reversal of the f u.
brinolytic
state is required,
treatment
with aminocaproic
acid
(EACA) can be instituted.
Plasma volume expanders
are indicated
to replace blood volume
deficit.
If blood loss has been large, Red Blood Cells (Human)
may
also be indicated.
If only Whole Blood (Human)
us available,
it may
also be used.
Alleigic Reaction
Incidence:
Reactions
determined
to represent
possible
anaphylaxis
have been observed
in 7 of 292 patients treated with Streptase’
(streptokinase).
These ranged in severity from minor breathing
difficulty to bronchospasm,
periorbital
swelling,
or angioneurotic
edema. Other milder allergic
effects have been observed
in approximately
12% of patients.
There was no apparent
relationship
to
dosage.
Management
of Allergic Reactions:
Mild and moderate
reactions
may be managed with concomitant
antihistamine
and/or corticosteroid therapy.
Severe allergic reactions
require immediate
discontinuation
of Streptase’
lstreptokinase),
with corticosteroids
administered
intravenously
as required.
Fever
Incidence:
One-third
of patients
treated with Streptase’
(streptokinasel
have shown increases
in body temperature
of 1. 5F or
more; the incidence
of fever1O4F
was 3.4%.
Management:
Symptomatic
treatment
us usually sufficient
to alle.
viate discomfort.
The use of acetamunophen
rather than aspirin is
recommended.
Phlebitis:
Phlebitis
near the site of intravenous
infusion
of
Streptase’
(streptokinase)
has occurred
in less than 2% of patients.
How Supplied
Streptase5
(streptokinase)
is supplied
as a lyophilized
white powder in 6.5 ml vials (in packages
of 10) with color-coded
labels
corresponding
to the amount of purified
Streptasex
(streptokinase)
in each vial as follows:
100,000
IU (yellow),
250,000
IU (green),
750,000
IU (blue).
In each vial there
is a 20% overfill above
that stated
on the
label. Each vial also contains
25 mg cross-linked
gelatin polypeptides and 25 mg sodium L-glutamate
as stabilizers.
HOECHST-ROUSSEL
AcamcALs
SOMERV1LLE
con
NEW
JERSEY
Distributed
by
Hoechst- Roussei Pharmaceuticals
Manufactured
by Behringwerke
U S. License
#97
08876
incorporated
AG
Edition
11/77
Here’s
New 5th Edition!
LABORATORY
MEDICINE:
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to
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examines
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ture-a
Both
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I
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To order
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call
call
of anemia.
important
in this
even
ST
ee
M.D.
color
to labo-
chapters
features
especially
are used
Mail
Miale.
64
patho-
relate
64 outstanding
contains
B.
and
Missouri,
Substantially
includes
an
Units
hemostasis.
as they
general
For
removed,
and
cells-and
responsibility.
added
SI.
marrow
emphasizes
this edition
also
thoroughly
functions
transfusions.
abnormalities
disease
has
Miale
bone
he
clinical
updated,
storage
author
and
on
John
illus.,
an exhaustive, superbly
Dr.
Throughout,
and
1,111
morphology,
blood
of hematologic
lysosomal
for
information
diagnosis
rewritten
book
hematology.
of peripheral
important
ratory
By
Hematology
development,
coagulation.
genesis
The
classic
of
hoiv:
-
-
-
-
-
TIE -
-
Complete
Westlune
-
-
46 05
and mail
Industrial
I
I
I
I
xxiv
BLOOD-THE
New
discoveries
in Iiaeinatology!
Beeson
Imferon’
(iron dextran
WHERE
David
A. Bass,
S’h
Cr,t’
2)()
)(
111)01
sle
U.S.
1,111,
Utiiv.
ot
111(1
()I ..Vlt’(ll(
lIlt’, Seattle;
‘t. ku )t . 1)1 \‘it’nI
RI
.‘\ssti
)i (It
\t’(1i(’i
II IFi’-t(l. 51
PP
U)77.
Phs
,\IedR’IIS’,
h.(X)
I1( )Wtlldtl
tl(’,
\VII1toI1-S,lIetn,
I1(’,
NC.
5) 7.1()
(1,111,1(1,1
.
()
tu
ht’n
#1650-X.
Order
1978 Clinics
in Haematology
than
List
another
periodical,
these
penetrating
symposia
bring you refinements
in technique
from the worlds
leading
authorities. Each issue gives
you the most current
reports
on the latest
haematologic
advances,
fresh perspectives
on problems,
and inlmedlately applicable
advice.
Consider
these 1978
syiilposia:
February
Pen natal Haeniatology;
June - Acute
Leukeniia;
October
Aplastic
Anaemia
and Bone Marrow
Transplantation.
More
-
Ikiblishes
peE
S(’ni))tI(
-
f
tImes
\edFl\
Send
tii(’
-
(‘rtlSIIlg.‘u’,trlv
pp.
SEll)-
(1):
-
-
(13-11,15 tppEu
(111
2()
Aer,tges
.
ti
is.
1(ee’-iui 5, lIt’-’- (hill-\
E
(liltiR’’-in IIaetiiitologs.
iii
.
i
Print
I
I
FLIL I
POSITiON
NAME
ADDHF
ANUS
AFF
ii
IATiON
ii
APF’LiI’AB(
i
-
Si:;
CITY
“1Aif
,heck
enclosed
n’n,s
ni-
/ll’
I’,
-s
-cihi”
I I”
WB.Saunders
West
Washinigloni
Square
USP)
ESTABLISHED
INDICATIONS
EXIST.
CON-
IRON
THERAPY
ACTION: Tfie iron dextran
complex
is dissociated
dcnthelial system. and hi.’ ferric iron is tr.unnspcirted
inncoryorati’d
into hemoglobin
by the reticuloenby transferrin
and
INDICATIONS:
For the treatmennt
of ironn di’ficienncy
annemna. intramuscular
or intravenous
inlecfi(nns
of iron are advisable
solely for
use inn those patients
in whom iron deficiency
anemnu is present.
its
c,uuse has been determined
and. it possible.
corrected.
and in wfiom
on,iI adminnistratnonn
of no n is unnsatisfa:tory
or impossible.
for
iv,iminle
inntolerance
to oral prep,unafionn
nesistuince
to oral iron
therapy.
nupid replenishment
of iron stones in selected
putienits
in
whom oral therapy
is ineffective.
such as Inypochniimnc
anemia
of
nnnf,inncy md hypochnomii:
arnenni,i of the lust trimester
of pregnancy,
selected
hemonrhagin:
c,ises
appropriate
steps sfnouid be taken to
correct
mid prevent
my evcessnvc’
blood loss
hal may have been
revealed
as an etnologic
factorl,
to replace
post-operative
transfusi(ini to some degree. inn those p.utients who cannnot be relied upon to
take oral medication
Imferon
(iron
dentran
innlectiiinn I iniectell
innlramusculanly
is the
preferred
and recommended
routi’ of administration
Intravenous
use c)f Imferonn should
hi: Iinniti’il to the lollowing
circumstances
a insufficient
muscle
nnass Ion deep intr,imusculan
inniection
b impaired
absorption
from the muscle
due to stasis or edema
c the possibility
of uncontrolled
initnannusculan
bleeding
fue to
tn,uiima as may occur in hemophilia
ci where mussive
and prolongeil
panintenal
therapy
is indicated
as
may be necessary
iii instances
of chinonic
substanntial
blood loss,
such as fannilial tt’l.ungic’clasiu
I’
iii those
circumstances
wfneni’, iii lii: opinion
of hi.’ physician.
the
bnnnelit of intravenous
adnniinistn,ilion
sut)stantiilly
outweighs
the
risk
CONTRAINDICATIONS: Hyperseinsihivity
Iii the product
All anemias
other than inI)nn deficiency
anemia
WARNINGS: This pnip,urition
should t)(’ iisi’il with (vfreme
care inn the
presence
of si’nious
innnpainnni’nnt il liven luni:hion
A risk of curcinogi’nt’sis
may attn’nnd tine inntn.innusculan
iniection
of
inonncanhohydnate
ciimplevi’s
Sui:h i:onnnplevi’s
have been found
unider evperiniental
condntionns
ho produce
sarconnnas when inlected
in ruts, mice and rabbits,
ansi possitdy
iii
hamsters,
iii very
large
doses
The numt)en (if Iunnons prcldui:eIl
was relatively
small.
and
such tumors
have not been pnoduce(l
in guinea pigs The long latent
pcniO(f hi’tween
hi’ innlectionn (if a pciti’ntial
n:arcnnogen
and the
appearannceofalumon
makes if innnpossible as yel to nneasure the risk
in mann However.
the risk if cancinogennesis
in man,
following
recommennded
therapy,
appears
to be extremely
small
Usage inn Pregnancy
in ,unninnals, lelal abnnormalities
have been
demonstrated
when Innfenon (iron devtran
inleclion(
was given early
inn pnegnn.unncy Safe use of Innnferon has not been established
with
respect
to adverse
effects
on human
fetal development
Imferon
sinoLil(l inot be used in early pregnancy
and should he used in women
of childbearing
potential
only when, in the ludgment
of the physi
cian. the potential
benefits
outweigh
the possible
hazards
PRECAUTIONS: Unwarranted
therapy
with parenteral
iron will cause
excess storage of iron with the consequent
possibility
xl exogenous
hemosiderosis
Such iron overload
is particularly
apt to occur
in
patients
with hemogiobinopathies
arid other
refractory
anemias
which might be erroneously
diagnosed
as iron deficiency
anemias
Patients
with iron deficiency
anemia
and rheumatoid
arthritis
may
have an acute exacerbation
of loint pain and swelling
following
the
initravenous
administration
of Imferon
(iron dentran
nnlectnon(
ADVERSE REACTIONS:
fl
Please
I
tliret’
‘stit’. 11,11(11)1 iLltl(I.
Ni) ,Id\
ill sI (IX)
C,tri,td,t 517.
CLEARLY
BLE TO ORAL
Beeson & Bass gives you detailed
coverage of the mysterious
eosinophil-its
structure, immunologic
role, and its involvement
in a wide variety
of clinical
problems.
Coverage
includes
a vast
amount
of empirical
observation
on the eosinophil’s
behavior
in
such
clinical
disorders
as: allergic
states;
parasitic
and microbial
infections;
skin diseases; neoplasms
and much more.
5(
ASH
FIRMED BY APPROPRIATE LABORATORY INVESTIGATIONS
CORROBORATING IRON DEFICIENCY ANEMIA NOT AMENA-
Now,
\Vasliingtoti
THE
THE PARENTERAL
USE OF COMPLEXES OF IRON AND
CARBOHYDRATES
HAS RESULTED IN FATAL ANAPHYLACTIC-TYPE REACTIONS
DEATHS ASSOCIATED WITH SUCH
ADMINISTRATION
HAVE BEEN REPORTED
THEREFORE IMFERON SHOULD BE USED ONLY IN THOSE PATIENTS
The [osinophil
Vol. XIVMajor Problems
in Internal
Medicine
B. Beeson,
Dlstltlgulslled
Adnijti.
; Frol.
uI
injection
OF
WARNING:
& Bass:
II Paul
Vett’r,tns
JOURNAL
Philadelphia,
c hnige
)
Co.
PA
19105
I
Annaphylactic
reactions
nncludirng
fatal anaphylaxis,
severe febrile
reactions,
artfnralgia
annd nnyalgia.
variable
degree of soreness
and nt (animation
at inlection
site (IM nniection(.
l)rown
skin discoloration
at nniectnonn site (IM inlection).
local
phlebitis
at inlection
site (IV intection(.
peripheral
vascular”flushing” with overly
rapid
IV administration.
hypotensive
reaction.
possible
arthritic
reactixatnonn
in patiennts with quiescent
rheumatoid
arthritis,
minor reactions
may include
heanlache.
transitnnry
paresthesias.
nausea.
shivering,
itching,
arid rash
DOSAGEAND ADMINISTRATION: Periodic hematologic
determinations are to be used as a guide in therapy, bearing in mind that iron
storage maylagbehmndthe
appearance of normal blood morphology
Since each course of Imferon must be individualized,
refer to the
package insert for complete directions for intramuscular
and intravenous use
IIIerreH
72260
ivnisei
SAFETY SENSORSDIGITAL DISPLAYSto facilitate
readings
of pump
flow rates
and centrifuge
speeds.
to detect
positive/negative
and air in
the blood tubing
accompanied
audible
and
pressures
path,
by both
visual
BUFFER SYSTEMan optional
feature to allow
intermittent
blood
flow
from the donor.
signals.
MOBILEwith a
built-in handle
and casters.
SEMI-AUTOMATIC
INTERFACE
POSITIONING
PORT (within channel)to control
the position
of the buffy layer
with minimal
operator
adjustments.
TOTALLY DISPOSABLE
BLOOD SEPARATION
CHANNEL
(underneath
to protect
cover)against
contamination
and
save
time.
ucing the
I
cell
The new IBM 2997 is a significant
improvement
over the
IBM 2990-6
experimental
blood
cell separator.
It’s a continuous
flow
device
which
removes
blood
from the donor, separates
it into its major
components,
and can be used to perform
plateletpheresis,
leukapheresis,
and plasma
exchange.
It’s simple
to operate
and has a
combination
of features
which
make the IBM 2997 the logical
choice
in blood
cell separators
today.
If you’d like to find out more about
what our 2997
blood
cell separator
can do for you, call (201) 329-7179
or write to us,
IBM Biomedical
Products,
P.O. Box 10, Princeton,
N.J. 08540.
BLOOD-THE
xxviii
JOURNAL
OF THE ASH
Announcing...
progress
hematology
VOLUME
Edited
From
in
X
by ELMER
the
B. BROWN,
M.D.
Preface
PROGRESS
IN HEMATOLOGY
embodies
the editor’s
continued
conviction
that a need exists for succinct,
authoritative
reviews
covering
the broad discipline
of hematology.
Some of these reviews are
devoted
to recent advances,
others reassess the state of the art. To be
effective
in meeting their goals, the chapters
must be written by authors
who can convey to readers with diverse backgrounds
and needs the
excitement
and the importance
of advances
in their field. I believe that
this goal has been achieved
by the twelve chapters
in this volume.
They are addressed
to a wide audience-medical
students,
resident
physicians,
clinicians,
teachers,
and investigators-seeking
both depth
and breadth of information.
Complement
in the Pathophysiology
of Hematologic
Diseases.
W.
T.
Shearer
and M. P. Fink, The Immune
Surveillance
System: Its Failure and
Activation.
P. A. Pizzo
and A. S.
Levine,
The Utility of Protected
Environment
Regimens
for the Compromised
Host: A Critical
Assessment. C. M. Jackson
and
J. W.
Suttie,
Recent Developments
in Understanding
the Mechanism
of Vita-
CONTENTS:
E. B. Brown
Introduction. G. Izak, Erythroid
Cell
Differentiation
and Maturation.
W. G. Wood,
J.
B.
C/egg,
Developmental
Hemoglobins.
Diagnosis
of
and
0.
J.
Weatherall,
Human
Prenatal
Hemoglobin
Disorders.
C. Hershko,
Storage
Iron Regulation.
P. J. Schmidt,
National
Blood
Policy,
1977:
A Study
in the
Politics
of
Health.
W. V. Mi//er,
The
Human
Histocompatibility
Complex:
A Review
for
the
Hematologist.
P. G.
Quie,
E.
L.
Biology
of
Y. W.
Mi//s,
Molecular
tosis
by
Events
Human
Atkinson
and
M.
Kan,
and
B.
Holmes,
During
PhagocyNeutrophils.
J. P.
M. Frank,
Role
of
1977,
432
pp.,
ISBN:
Prices
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A Subsidiary
min
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and the
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il/us, 38.5011227.35
to change
without
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& STRATTON
of Harcourt
Brace
Jovanovich,
K Antagonist
Drug
Consequences
of
in Blood CoagulaA. Mcintyre,
Newer Develin Nuclear
Medicine
Apto Hematology.
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OVAL ROAD, LONDON NW1 7DX
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AT PLAY
AT SLEEP
AT WORK
MODEL
AS*3B
DEDICATED TO INNOVATIONS IN INFUSION PUMP TECHNOLOGY
FEATURES
OF THE AS*3B
#{149}
Economical
to operate
#{149}
Overall
controls-the
Infusion
by the physician
infusion
period
ranges
rate
from
is
30 hours
in cm (w x I x h): 5.1 x 15.2 x 3.3
#{149}
Weight:
310 grams
Auto-Syringe
infusion
pumps have been well
received
in many clinical
and outpatient
settings. For example,
in hematology,
although
all models
are acceptable
for use, model
AS03B
has been the preferred
pump for deteroxamine
administration.
Deferoxamine
is
primarily indicated for the treatment
uals who are afflicted with chronic
to hold
overall
and AS62B
of individ-
iron overload. Likewise,
model AS03B has been found
to be very adequate
for the administration
of
cytosine
arabinoside
(Ara-c)
in the chemotherapeutic
treatment
of leukemia.
larger
uto-,
Lsyringd.
of their
of 5-fluorouracil,
5-fluoro-
2-deoxyuridine,
heparin, various antibiotics,
and many, many other pharmacological
agents.
The A562B and A502c
have rechargeable
capacity
batteries
and
to independently
both
program
have
the
the volume
to be infused and the elapsed time interval
between
infusions. Their programmability
ranges from simulation of an intermittent
nursing drug administration regimen (e.g. as
long as six hour time intervals between
slow
bolus infusions can be programmed)
tinuous low volume infusions.
to con-
Since Auto-Syringe pumps were designed to
hold any standard
brand syringe the daily cost
of operation
is minimal.
prefer
our infusion
pumps when applicable to other large volume
parenteral
ing equipment
the A502B
Also,
pump-
because
and AS62C
each weigh only 480
grams thus permitting
trouble-free
ambulation.
MODEL
AS*2C
r--a
because
volumes
and their
have
been used for
versatility,
nickel-cadmium
4 to
#{149}
Amenable
to IV, IA, IM, and S.Q. admInistration routes
#{149}
Powered
by a 5.6 volt mercury battery
#{149}
Size
AS62c
capacity
greater
the administration
#{149}
Great patient acceptance
#{149}
Simple to operate and understand
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No external
programmed
Similarly,
AUTO-SYRINGE,
INC.
1095 Route 110, Farmingdale
New York, N.Y, 11735
U.S.A.
(516)
752-9300
many patients
AMICAR
AMINOCAPROIC
INTRAVENOUS’
TABLETS’
ACID
SYRUP
INDICATIONS: AMICAR has prnied uselul, in ninny instances. in he neil
merit nf excessive bleeding which results rum sisrerrsc hi’per!ihnrinoiisis .inI
ursfldry fituiro/isis
In life nhneanenirq siruationis. tnesh whole blond inansfusionns
libninogen irfusions. and onhen emergency measunes maybe required
Systemic hyperfnbynnlysis. a pathological condition. may frequently be assn
ciated with surgical connip/ica/ions lollowinij heart surgery (with or without
cardiac bypass pnocedunesl arid ponacaval shunt. lremato/ogica/ disorders such
is aplastic uremia, abrupfio plac,enrrae. .heparic cirrhosis. nreoplasric disease
such as carcinoma ol the prosn,ite.lung. stonnach. and cervix
Uninary tibninnulysis. usually a normal physiological phenomenon. may lne
guentlybeassocianedwithlile
thneanennngcomplicatnonsfollowing
sevenetrauma,
inoxia. and shock Symptomatic ol such connplications is surgical lrema!uria
following unosnatectomy and nephnecnomyl on non surgical hematunia laccom
ianying polycysnic on neoplastic diseases of the genitouninary systeml
CONTRAINDICATIONS: AMICAII should not be usedwhen thereisevidence
of an active intravasculan cloning ptocess
WARNINGS: Sale use of AMICAR has not been established with nespect to
.ndverse elfects upon fetal development therelone, it should not be used iv
women of child beaninq potential and particulanly duning early pregnancy, us
less in the udgmert of the physician the potential benefits outweigh the
possible hazards
PRECAUTIONS: AMICAR .arninocaproic ,vi’id has a very specific action in
that it inhibits both plasmunoqen acnivaton substances and, to a lesser degree,
plasmin activity The drug should NOT be administered wrthovt a definite diag
nosis. and on laboratory findings iodicalnve of fryperfibninolysis lhyperplasnnu
nremia(
Stefannni, M and tjameshek. W The Hemorrhagic Disorders. Ed 2. New
honk, Grune and Straflon. pp 510514. 1962
The use of AMICAR should be accompanied by tests designed to determine
he amount of fibrinolysis present There are presently available al general
nests. such as those for the determination of the lysis of a clot of blood or
plasma and lbf more specific tests for the study of various phases of tibrnnolytnc
mechanisms These lamer tests include both semnguantitatnve and gvantntatnve
lechnics forthe determination of profibrnnolysnn. fnbninolysnn, and antnfnbrnnolysnn
Animal experiments indicate particular caution should be taken in adminis
ieninnqAMICAR to patients with cardiac, hepatic or renal diseases
Demonstrable animal pathology in some cases hive shown endocardial hem
onnhages and myocardial fat degeneration The use of this drug should thus be
restricted to patients in whom the benefit hoped for would outweigh the hazard
Physicians Ate cautioned in the use of this product because of animal data
showing rat teratogenncily and kidney concretions
Rapid nnlravennous administration of the drug should be avoided suirce this
ni.iy induce hypotension, bradycardia and or arrhythmia
Onnecase ofcirdiac and/nepariclesioos observed in man has been reported
tIne i.nluent received 2 grams of aminocaproic acid every 6 hours for a total
fuse of 76 granns Death was due In continued cerebral vasculan hennonnhage
ycnnlnc changes in the heart and liven were noted at autopsy
If ii is accepted than hibrinolysis is a normal process, potentially active at all
linnes no ensure the fluidity of blood. then it must also be accepted that inhibi
inn of fubninolysus by amnnocapnoic acid mae result in cloning or thrombosis
However. there usno definite evidence that administration of amnnocapronc acid
has been responsible for the Iow reported cases of intravascular clotting which
followed this treatment Rather it appears that such intravascular cloning was
most likely a result of the hnbninnlytic disease being treated
than been postulaled that extravascular clots formed us vivo with incorpo
med aminocapronc acid may rot undergo spontaneous lysns as do normal clots
However, it us she consensus of experts that the few reported cases of extra
v.iscolan
cloningcouldhave occurredin the absence of nminocaproic acid
reanment
ADVERSE REACTIONS: Occasionally nausea, cramps, diarrhea, dizziness,
rininitus, malaise, coniunctnval suffusion, nasal stuffnness. headache, and skin
r.nsh have been reported as results of the administration of aminocapronc acid
Only rarely has it beennecessary
to discontinue or educe medication because
of one ormore oftheseeffects
Thnombophlebntns, a possibility with all intravenous therapy, should be
guarded against by strict aTentnon to the proper insertion of the needle and the
fixing of its position
DOSAGE AND ADMINISTRATION: INITIAL THERAPY An initial priming
dose of & grams of AMICAR administered either orally or intravenously followed
by no 1’. gram doses at hourly intervals thereafter shovld achieve and siis
urn plasma levels of 0130 mg ml of the drug This is the concentration ap
n.nnentlynecessary for the inhibition of systemic hyperfnbninolysns Administration
ofmore than30 grams in any 24 hour period is not recommended
INTRAVENOUS: AMICAR asrinocap.nroic acid intravenous
isadministered
by
infusion, utilizing the usual compatible intravenous vehicles le g Sterile Water
I or lnection.
physiologic
saline.
5#{176}’
dextrose or Ringer’s Solutnonl RAPID
INJECTION OF AMICAR INTRAVENOUSUNDILUTED INTO A VEIN IS NOT
RECOMMENDED
For the treatment of acute bleeding syndromes due to elevated fibrinolytic
activity. ntis suggested that 1610 20 cc 14 to 5 gramsl of AMICAR intravenous
be administered by infusion during the first hour of Ineatnient, followed by a
cosiinunnq infusion at the rate of 4cc IT 0 graml per hour This melhod of treat
ment would ordinarily be continued for about R hours or until the bleeding
situation
hasbeescontrolled
ORAL THERAPY: Itthe patient is able to take medication bymouth,an ides
tical dosage regimen may be followed by administering AMICAR Tablets or
25”, Syrup as follows For the treatment of acute bleeding syndromes due to
elevated
fibnisolytic
activity,
it is suggested hat TOtablets 15gramsl or 4 tea
spoonfuls of syrup (5 gramsl of AMICAR be administered during the first hour
of treatment, followed by a contisuing tate of 2 tablets It graml or 1 teaspoonful
ofsyrup(t’/ grams( per hour Thismethodof treatment
wouldordinarily
be
continued for about R hours or until the bleeding situation has been controlled
REV 112
_______LEDERLE
LABORATORIES.
A Division of American Cyanamfd
Company.
Pear) River. New York 10965
055
7
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be
Tabular
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hemopoiefic
P (ed):
1967
not
the
Human
in Fames
4. Baltimore,
JB,
studies
7.
by
Legends
and
of book
same
con-
J:
report,
vol
Natvig
the
the
Practical
1965,
p 100
Wiley,
contributor.
on
numbered.
1969,
least
relettered
to the
In Vitro,
at
to
Technic
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Blakiston,
Minowada
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Cells
G,
A progress
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ceedings
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Moore
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1970
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RD: Histopathologic
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enough
The
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Chapter
6.
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Histochemistry
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ASH
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REFERENCES
References
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medical
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Documents,
ington,
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ordered
form,
that
tacting
one
1. Beutler Eu The
tion
on
sickle
cell
OF
REFERENCES
effect of methemoglobin
J Clin
1961
Journal
the
Invest
forma40:1856,
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REFERENCES.
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tions-is
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order
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to the
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Editor
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subject
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of
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months
These
con-
will
be
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as
to
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of
BLOOD-THE
JOURNAL
OF
THE ASH
xxxv
Hemoglobin A2
Testing System...
Simpleasl,2,3
Using prefilled, miniature chromatographic
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Hemoglobins”
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Humoral Aspects of Transplantation
A
“TRANSPLANTATION
Edited
REPRINT
by
ARTHUR
The
New
1. RUBIN,
Rogosin
York
Sections
Kidney
are
Pregnancy
Analysis
of
Responses
to
to
of Placental
1976,
Send
Prices
HL-A
Placental
Eluates;
192
A sampling
Survival
and
$17.00
wmth
subject
GRUNE
A Subsidiary
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Immunogenic
The
Serum
The
of
in Specific
Action
and
of
Passive
to change
save
without
postage
plus
50C
handling
notice.
& STRATTON,
of Harcourt
Brace
Jovanovich,
INC.
Publishers
111 Fifth Avenue, New York, N.Y. 10003
24-28 Oval Road, London NW1 7DX, England
and
Some
UnresponThymic
Hor-
Properties
Enhancement.
#{163}12.05
ISBN 0-8089-0963-0
and
for
in Serum
Immunologic
Factors
includes:
Basis
Properties;
Factors
Mode
Genetic
Antigens
Differentiation;
Center,
Immunosuppressive
HL-A
Humoral
T-CeII
Medical
of articles
Rates;
Antigens;
Antigens;
to
Retroplacental
pp.,
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are
Antibodies,
Characterization
M.D.
Hospital-Cornell
Globulin.
of Transplantation;
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Antigens,
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Its
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xxxvi
BLOOD-THE
Quality
JOURNAL
OF
THE
Control
in Haematology
Symposium
of the International
for Standardization
Edited
Committee
in Haemotology
by S. M. LEWIS
Royal Postgraduate
London,
England
Medical
School
J. F. COSTER
National
of Public
The Netherlands
Institute
Bilthoven,
Contents:
Russell J. Eilers:
Principles
Assendelft
and A. H. Holtz:
Health
quality
control.
0. IV. I/an
Concepts
of inter-laboratory
trials:
an international
haematological
survey.
P. G. Ward and S. M.
Lewis:
Inter-laboratory
trials:
a national
proficiency
assessment
scheme
in Britain.
Jo/rn
A. Koepke:
Inter-laboratory
trials:
the
quality
control
survey
programme
of The College
of American
Pathologists.
A/am F. Goguel:
Inter-laboratory
trials:
surveys
in
France.
S. M. Lewis:
Standards
and reference
preparations.
P. Crosland
Taylor:
Problems
of the red-cell volume.
I. Chanariii:
Critical
appraisal
of the PCV. Brian S. Bull: A statistical
approach
to quality
control.
J. E. Pettit:
Inbuilt
quality
control.
D. W.
Penner and C. C. Merry:
Quality
control
of qualitative
test in
haematology.
D. Wittekind
and W. L#{246}hr:
Purification,
standardization and quality
control
of Romanowsky
dyes. L. Poller
and
G. I. C. Ingram:
Standardization
and quality
control
of anticoagulant
control.
Robert M. Schmidt:
Control
of diagnostic
haematology
products.
Irwin M. Weisbrot:
Product
evaluation.
L. S. Sacker:
Specimen
collection.
J. F. Coster: The cost of quality
control.
Subject index.
1975,246
NB,:
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of total
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Prices are subject to change without notice.
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ASH
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xxxvii
ASH
GRADUATE
OF MEDICINE
ANNOUNCES
SPECIALTY
Hematology
able
REVIEW
MAY
IN HEMATOLOGY
15-19,
1978
detailed
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registration
forms, address:
avail-
Two
program
or three
with
2nd
research
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University-Ingham
Medical
Center
Send
For
1978.
July
year
COURSE
fellowship
c.v.
year
Michigan
program.
to:
and
more
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Dept.
Michigan
REGISTRAR
M.D.,
of Medicine,
State
C.H
.M.,
University.
48864.
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Telephone: 312-733-2800
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AND
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and
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Diagnosis,
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AMA
Category
tion.
Information:
Medi-
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and
Medicine.
1
accreditaOffice
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of Medicine,
Box
8063,
660
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MO.
(314)
367-9673.
Center,
for
these
5.
Brooklyn,
care
N.Y.
of
in the
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THROMBOSIS:
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