Actolind® w Solution Actolind® w Gel

Actolind® w Solution
Actolind® w Gel
Irrigation, healing, moistening and
care product for skin,
Against all resistant microorganisms
including
mucosa and wound
“Your first choice”
for decontamination of
antibiotic resistant microorganisms
(MRSA, MRE, VRE)
“Your first choice”
for burn and wound care
www.actogmbh.com
[email protected]
ACTIVE INGREDIENT
PROPERTIES
INGREDIENTS
POLYHEXAMETHYLENE BIGUANIDE (PHMB)
Polyhexamethylene biguanide (PHMB) is a strong cationic
chemical antiseptic that shows a high tissue compatibility
with a broad mıcrobial spectrum. It is also known as
Polyhexanide, Poly(iminoimidocarbonyliminoimidocarb
onyliminohexamethylene) hydrochloride. The molecular
formula of the substance is (C8H17N5)n HCl.
PHMB to acidic phospholipids, i.e. Phosphatidylglycerol
and Diphosphatidylglycerol that are present on the cell
membrane of pathogenic microorganisms(1). Thus, the
derivate is an ideal active substance for infected, dried
and persistent wounds.
Action mechanism of PHMB is examined in detail(3).
Steps of its primal bactericidal effect are listed below:
• Rapid penetration on bacterial surfaces
• Selective bonding to specific areas
• Elimination of bacterial defense mechanism
• Penetration to the cytoplasmic membrane
• Disruption of cytoplasmic membrane and exuding of intracellular fluid, electrolyte and macromolecules to extracellular area
• Lysis and eventually bacterial cell death
Significant similarities were found in terms of structure
and effect between antimicrobial peptides and PHMB.
This issue is explained by the similarities between
chain structures of antimicrobial peptides and linear
chain structure of PHMB, which is formed by cationic
biguanide groups and hydrophobic hexamethylene
groups(2). PHMB has below listed properties that are
required for new generation antiseptics:
• Safe, broad-spectrum antimicrobial effect,
• Rapid effect,
• Continuous effect even under biological stress,
• Accelerating effect of wound healing,
• High tissue and cell compliance,
• Less likely to cause allergic reactions, sensitization or resistance,
• Low rate of absorption into systemic circulation.
Chemical structure is as shown below:
POLOXAMER
Poloxamers are synthetic tri-block copolymers of
polyethylene oxide and polypropylene oxide. They are
amphiphilic, non-ionic surfactants that cover over 50
different types and commonly used in pharmaceutical
and cosmetic formulations as a dispersing agent,
emulsifying agent, solubilizing agent, tablet lubricant,
wetting agent, gelling agent and thickener. Non-ionic
surfactants show more surface and emulsification activity
in comparison to anionic and amphoteric surfactants at
same concentrations. Poloxamers are usually accepted
as non-toxic and non-irritant ingredients used in oral,
parenteral and topical formulations and possess less
toxicity compared to other surfactants i.e. betaines. The
surface-active nature of poloxamer reduces the surface
tension on the skin, thus the adhesion of microorganisms
to the wound is minimized. This effect improves the
efficiency of PHMB and reduces tissue damage arising
from irrigation or debridement.
Pharmacokinetic Properties
It is applied on skin, mucosa and wound topically. No
evidence has been found on the systemic absorption
PHMB.
The fact that, its polymeric chain structure and relatively
high molecular weight, which is about 3000 g/mol
reduce the risk getting in the circulatory system.
Chemical structure is as shown below:
Antimicrobial Effects
After lots of studies about antimicrobial effects of
Polyhexamethylene biguanide, it is stated that PHMB
has strong microbicide effects on gram positive and
negative bacteria, fungi(6), HIV(7), some other viruses
and amoebas(8,9). According to in vitro studies of gram
positive and negative bacteria, it is stated that PHMB
kills E. coli, S. aureus, P. aeruginosa, E. hirae, C. albicans,
Klebsiella sp. and Enterobacter sp. in 5-10 seconds
completely(4,5,10,11).
According to studies, the antimicrobial effect continues
in the presence of blood and albumin. The effect,
however, is reduced in the presence of mucin and
chondroitin sulfate.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Polyhexamethylene biguanide (PHMB) is a polymeric
biguanide derivative (ATC-Code: D08AC05). It shows
a strong microbicide effect on gram +/- bacteria,
fungi, some viruses and amoeba. Together with this
strong microbicide effect it also possesses high tissue
compatibility. The effect is due to the selective binding of
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ACTIVE INGREDIENT
Microbiologic Activity;
• Fast action
• Broad spectrum
• Effective against whole gram positive and negative bacteria
• Effective against antibiotic resistant microorganisms (MRE, i.e. MRSA and VRE)
• Effective against enveloped and some non-enveloped viruses
Tissue Compatibility
PHMB shows high tissue compatibility. The tissue
compatibility of PHMB based on its activity against the
acid lipids contained within the bacterial cell membranes
and minor effect on the neutral lipids of human cell
membranes. This helps to prevent damage to the
surrounding healthy tissue.Due to its low toxicity, it can
be applied over a long period of time.
In order to estimate the compatibility of an antiseptic, its
cytotoxic effect is needed to be evaluated together with
its microbicide effect(13).
Biocompatibility Index (BI)
Antiseptic concentration destroying 50% of mouse
fibroblast cells
BI: --------------------------------------------------------------------Antiseptic concentration decreasing 3 log10 (99.9%) of
bacteria colony number
PHMB also helps and accelerates wound healing at
microbicide concentrations. Antiseptics primarily need
to provide reproduction of cells that are responsible
for wound healing. A study with keratinocytes states
that PHMB increases keratinocyte production about 0.2
µg/ml(14). Another study with pigs states that PHMB
accelerates wound healing(15).
PHMB is also effective on bacteria that form biofilms.
Biofilms are polymeric structures consist of bacteria and
polysaccharides secreted by bacteria and formed mainly
on solid surfaces. The effect of antibiotics and antiseptics
on bacteria in biofilms is generally is reduced. The effect
of PHMB on S. epidermidis and E. coli is slightly reduced
in existence of biofilm formation, even though it is stated
as the most effective antiseptic(12).
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APPLICATION AREAS
APPLICATION AREAS
Actolind® w Solution/Gel is used for cleaning,
decontamination, irrigation and moistening of infected,
dried and disintegrated (chronic and acute) skin and
mucosa; it is also used before application of bandages,
gauzes, compresses, wound fillers and other absorbent
materials.
1. Decolonization of Antibiotic-Resistant Pathogens
→ MRSA Decolonization
Methicillin-resistant S. aureus is a gram positive bacterial
strain, which causes pneumonia, wound and hospital
infections. They are resistant to several antibiotics.
Unsuitable antibiotic usage and insufficient protective
infection control cause these bacteria to spread. MRSA
can simply be passed by hand contact.
MRSA does not always cause an infection. Some people are
only carrier of MRSA and do not show any infection sign.
Detection of MRSA carriers is very important for hospitals
and nursing houses. Sterilization of MRSA carriers from
MRSA is called “decolonization”. Transmission of MRSA
can only be prevented by continuous and systematic
infection control method. Depending on the location,
colonization and infectivity of resistant pathogen,
antisepsis and chemotherapy should be applied(29).
Actolind® w Solution is a perfect decolonization product
with strong bactericidal effect on MRSA. It is easy to
handle and softly applicable to the infected area.
for Acinetobacter infections are: use of mechanical
ventilation, invasive processes i.e. central urinary catheter,
and resistance against a broad spectrum of antibiotics.
Mortality rates in A. baumannii infections vary depending
on diverse factors; in fact it is known to be between 50-60%.
The studies showed that polyhexanide is effectively used
on animate and inanimate surfaces that is colonized with
multi drug-resistant Acinetobacter for antisepsis and
disinfection.
→ Whole Body Decolonization
Whole body, including hair, should be wiped with Actolind®
w Solution according to aseptic methods, for 15 minutes
for 3 days and the patient must subsequently be bathed.
Application
After showering for 1-2 minutes with warm water,
Actolind®w Gel should abundantly be rubbed – just as
liquid soap and shampoo – on the moist and warm skin,
including the hair. After making sure that Actolind®w Gel
contacted the skin for 10 – 15 minutes, the patient should
take a shower with warm water.
→ VRE Decolonization
Vancomycin-resistant Enterococci is a gram positive
bacterial strain, which cause severe hospitals infections
mainly in chronic hemodialysis patients. VRE can be carried
by healthy people who have come into contact with the
bacteria without any infection signs. The most likely place
where such contact can occur is in a hospital. Actolind®
w Solution is a perfect VRE decolonization product with
strong bactericidal effect on VRE. It is easy to handle and
softly applicable to the infected area.
→ Nasal Decolonization
For cleaning and decontamination, apply Actolind® w Gel
to front side of the nostril with a cotton swab. Wait for 2-5
minutes until all sloughed and solidified secretion residuals
are raveled out. After this, wipe with a clean cloth and
leave a moisturizing layer. Incrustation formation within
the nose should be prevented by scrupulously applying
this process a few times in a day, at least in the morning,
noon and evening. The intranasal gap should constantly be
cleaned with Actolind® w Gel to avoid new microorganism
formations. Frequent usage does not cause formation of
any resistance.
→ Acinetobacter baumannii Decolonization
Acinetobacter baumannii is a pleomorphic gram negative
bacterial species, which can remain alive for a long time in
extreme environmental conditions and as an opportunistic
pathogen in humans, easily colonize and affecting
people with compromised immune systems in hospital
environment. In last decades it is frequently observed
that A. baumannii causes severe nosocomial infections
in Intensive Care Units (ICU) such as pneumonia, urinary
tract infection and surgical wound infection by colonizing
in respiratory tract, oropharynx, skin, urinary, and gastrointestinal system. Therefore it is rated as an increasingly
serious hospital-derived infection. Principal risk factors
-4-
APPLICATION AREAS
Application
Actolind® w Gel should be applied within the wings of
nose 3 times in a day during 5 days. For control, following
the end of 5-day application period, 3 separate negative
result should be obtained in the control examples which
are to be taken beginning from 3rd day at the earliest.
3. Wound Care with Actolind®
Infection Control on Wound
Chronic Wound Infections
Chronic wounds are generally complicated and have a
long healing process. It may not be healed for months or
years because of underlying diseases and complications
occurred during the recovery. For chronic wound
treatment, a multifactorial approach is needed while
taking care of underlying pathophysiology. Before wound
closure, an environment suitable for tissue repair is
needed.
Therefore the steps below are needed:
• Removal of dead tissue,
• Ensuring moisture balance,
• Removal of bacterial imbalance,
• Removal of barriers to start healing at epidermal borders.
If the number of bacteria on the surface tissue of the
wound exceeds 105-106 per gram/tissue, it may slow
down the recovery due to released toxins. In this case
antiseptic usage is necessary. Antiseptic should be chosen
after a risk - benefit assessment. Otherwise, even though
the chosen antiseptic eradicates the bacteria, it may slow
down the wound recovery.
With its strong broad spectrum microbicide effect, high
tissue compatibility and accelerating effect on the wound
recovery, PHMB is the first antiseptic choice for chronic
non-healing persistent wounds(16). This activity is stated
on a number of pre-clinical and clinical studies.
2. Body Care with Actolind®
→ Oral Care
Carious clinic studies demonstrated that the oral care
performed with PHMB removes the biofilm, which
ceases the damaged tissue recovery, more effectively
and prevents the reformation of plaques and reduces the
oral bacteria level(28).
Application
Actolind® w Solution is used with oral care sticks. For
oral care: clean inside the mouth two times in a day with
sticks that are moisturized with Actolind® w Solution.
→ Facial Care
The face is thoroughly washed with a single-use shower
sponge, soaked with Actolind® w Solution. Special
attention should be given that the whole face is covered
with Actolind® w Solution. Eyes should be closed during
this step. Eyelids and edges are also carefully cleaned with
the same sponge. Areas cleaned and decontaminated on
the skin are wiped to dry after 1 – 2 minutes. Sponge
should be thrown away afterwards.
→ Hair Washing
Before taking bath, the hair should completely be
wetted by means of a bath sponge completely soaked
with Actolind® w Solution and covered with a clean
towel. It should be wetted for 3 – 5 minutes to take
effect. Afterwards, the hair is to be completely dried.
Alternatively, the hair can be washed with any shampoo
and dried afterwards.
→ Decubitus, Diabetic Foot and Venous Ulcer Care
Related areas should primarily be cleaned and washed
with Actolind® w Solution. In order to provide the best
effect, Actolind® w Gel should be applied as well, after
cleaning of the related areas with Actolind® w Solution.
In this way, Actolind® w Gel takes the place of damaged
skin and avoids heat loss and dehydration by forming a
barrier between the outer environment and the skin, and
thus prevents the living tissues from drying by keeping
them humid. It also prevents malodor and recolonization.
With respect to the dressing change plan, Actolind® w
Gel should be applied as a thicker layer for long-interval
dressing changes, and as a thinner layer for frequent
dressing changes. Thus, the dressing is prevented from
sticking on the tissue.
→ Body Care
Actolind® w Solution can also be used for washing, to
remove unwanted scent and avoiding the deterioration
of the skin integrity due to immobility, malnutrition,
circulatory disorder, skin dryness, long exposure of
the skin to wetness and moistness, and so forth. Body
secretion, residuals and temporary microorganisms are
removed from the body with this application. Skin health
is maintained and increased, while personal comfort of
patients is ensured.
Application
The whole body, especially armpits and inguinal should
be wiped with Actolind® w Solution on a daily basis
according to aseptic methods followed by a bath.
-5-
APPLICATION AREAS
4. Surgical Site Care with Actolind®
→ Actolind® Usage before Surgical Operation
In accordance with the aseptic methods, the area which
is to be operated should be wiped with Actolind® w
Solution.
→ Burn Treatment
The most important complication on burns is infections
since the necrotic tissue creates a favorable medium
for the formation of microorganisms. Infection control
on wound requires debridement of the dead tissue,
strengthening of the immune response, adequate
nutrition and usage of topical and systemic antimicrobial
agents. Plenty of topical antimicrobial agents kill
fibroblasts and keratinocytes that are proliferated during
tissue recovery while they kill pathogens on burn surface.
This situation causes a delay in burn recovery and increases
the infection risk. Therefore most of the antimicrobial
agents are not suitable for long term burn treatment due
to their high cytotoxic effects. PHMB is one of the most
suitable antiseptics for chronic wound and long term
burn treatment thanks to its strong microbicide effect
and high tissue compatibility. According to a comparative
study with Povidone-iodine and silver nitrate, which
are commonly used antiseptics for burn treatment, it
is stated that PHMB predominates on long term burn
treatment compared to other agents(17).
→ Catheter Care with Actolind®
In accordance with the aseptic methods, the area on
which the catheter is to be applied should be wiped with
Actolind® w Solution.
→ Stoma Care
It can be used for colostomy, tracheostomy and urostomy
care.
Application
In accordance with the aseptic methods, stoma area
should be wiped with Actolind® w Solution.
Application
For the burn treatment, removal and decontamination
of organic dirt, which are stuck on the tissue surface,
preventing the damaged tissue surface from drying and
secondary infection are the primary objectives. For this
reason, related areas should be washed with Actolind® w
Solution or wiped with a dressing cloth wetted with the
solution. In order to avoid bleeding and pain that might
occur during burn dressing, bandages should be wetted
with Actolind® w Solution and hence they can easily be
loosened.
• First stage
• Second stage
• Third stage
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APPLICATION AREAS
5. Actolind® Usage in Clinics
→ Usage in Urology Service (Urologic Catheter)
In order to avoid urinary infections, perianal area care
should be applied with Actolind® w Solution before
mounting urinary catheter and during the period that the
patient caries it.
THE RULES FOR THE PERSONNEL WHO APPLIES THE
CARE TO COMPLY WITH
• Ornaments should be removed before the operation.
• Hands should be washed with Actoman® and disinfected
with Actoderm® according to EN 1500.
• Gloves should be worn. Aseptic technique should be followed in all applications.
• If different applications on one patient have to be
performed (e.g. perianal, wound care), hands should
be washed and the gloves should be changed during
intervals.
• Gloves should absolutely be changed when passing from one patient to another.
• Hands should be disinfected with Actoderm® after removing the gloves.
• All dressing materials should be deemed as medical waste.
→ Usage in Gynecology Clinics
(Abortion and Spiral Mounting)
It is used for cleaning, care and removal of malodors of
perineum area before the operations such as abortion
and spiral mounting in gynecology clinics. Perineum and
perianal area should be wiped with Actolind® w Solution
from top to bottom.
→ Usage in Otorhinolaryngology
Wetting the pads placed inside the nose after nose
operations with Actolind® w Solution, provides easy and
painless removal of the pads.
→ Cutaneous Disorders (Dermatology)
Actolind® w Solution is used as skin decontamination
and supportive skin treatment for patients susceptible
to infections, due to underlying diseases that deteriorate
the skin integrity, such as neurodermatitis or atopic
eczema.
Apply each figure for 5 sec.
→ Usage in Dentistry
Before and after surgical operation, it removes
efficaciously the “bacterial dental plaque” that causes
diphtheria illness and avoids foul breath. Several clinical
researches demonstrated that the reformation of plaques
is prevented and the amount of oral bacteria is decreased
by mouth washing with Polihexanide(28).
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PROSPECTUS
Actolind® w Solution
Actolind® w Gel
Irrigation, healing, moistening and care products used
for skin, mucosa and wound.
• People who have hypersensitivity against any ingredients should not use it.
• Should not be applied on hyaline cartilage, central nervous system, middle and inner ear.
• Should not be used in the first four months of pregnancy.
• Should not be used with anionic soaps, enzymes, oils and ointments.
DESCRIPTION
Actolind® w Solution and Gel are medical products
containing PHMB, auxiliary substances, and distilled
water.
GENERAL SAFETY INSTRUCTIONS
For external use only. Do not use it as an infusion or for
injection purposes. Do not drink! If swallowed, drink plenty
of water and consult a physician immediately. Since there
is no sufficient information and experience available for
usage on inner ear canal, it is recommended to prevent
direct contact of the product with the eardrums. Do not
expose product bottles to direct sun light and store at
room temperature. It is a medical product. Keep out of
reach of children and store in original packaging.
ANTIMICROBIAL EFFECTS
Microbiological studies of Actolind® w Solution/Gel
were performed on test organisms shown below by
Hygiene Nord GmbH Greifswald, Prof. Dr. A. Kramer and
found effective in 30 seconds(23-24).
Staphylococcus aureus
MRSA strain H-5-24
Staphylococcus aureus
MRSA strain “E. Nord”
Staphylococcus aureus
MRSA strain, DSM 2569
Staphylococcus aureus ATCC 6538
Pseudomonas aeruginosa ATCC 15442
Escherichia coli NCTC 10538
Enterococcus hirae ATCC 10541
Candida albicans ATCC 10231
Composition
100 g of Actolind® w Solution contain;
Polyhexanide, auxiliary substances, distilled water.
Regarding these studies, it is stated that the antimicrobial
effect continues in the presence of blood and albumin in
the medium, but is decreased in the presence of mucin
and chondroitin sulfate.
PHYSICAL PROPERTIES
• Clear, colorless and odorless.
• Non-toxic
• Actolind® does not contain iodine compounds,
alcohol, benzalkonium chloride and octenidine
dihydrochloride.
• Actolind® can be applied directly and undiluted onto (un)damaged skin and transition zones of mucosa membrane. Rinsing is not required.
• Actolind® is compatible with the pH of the skin.
• Actolind® does not cause any irritation and can be applied in an easy and painless manner.
• Actolind® can be used in the needed frequency, as required for an effective treatment.
• Actolind® effects actively in a quick manner.
• Actolind® eliminates undesirable odors caused by the colonization of bacteria or fungi.
• Actolind® clinically and dermatologically tested, rated
as “very good”.
Composition
100 g of Actolind® w Gel contain;
Polyhexanide, auxiliary substances, carrier substances
(glycerin, hydroxyethyl cellulose), distilled water.
CONTRAINDICATIONS
Actolind® is contraindicated for situations as shown
below:
Actolind® w Solution and Gel are Class III Medical
Products within the scope of 93/42/EEC Medical Devices
Directive with amendment 2007/47/EC.
-8-
PROSPECTUS
Actolind® Swab
CATHETER INLET CLEANING WIPE
Actolind® Genital
Cleaning, care, deodorizer and anti-itch gel for genital
area.
• Dermatologically tested
• Non-allergic.
• Non-toxic.
• Colorless, odorless.
• Compatible with vaginal pH.
• Supports treatment.
• For itching and irritation in external genitalia after menstruation, pregnancy and during menopause.
• For postpartum antisepsis of genitalia.
• For eliminating odors generated in the genital area caused by bacterial infection.
• As an external genital wash for removal of microorganisms and prevention of infection before and
after sexual intercourse.
• Relief of itching and irritation caused by microorganisms.
• For hygiene in genital area after diseases or surgical operations.
• Before and after fitting a urinary catheter.
It prevents the entry of microorganisms into the body
during mounting the catheter.
AREA OF USE
• It is used to clean the inlet before mounting the catheter
(such as intravenous, urinary catheters).
• Cleaning of dialysis fistula and graft site.
• Instalment and maintenance of Central Venous Catheter
(CVC).
• Cleaning of the area before cardiac catheterization.
• Cleaning of the peritoneal dialysis area.
METHOD OF USE
Clean the direct catheter inlet by wiping with a single
gesture from far to near and from clean areas to dirty
areas. After using Actolind® w Swab, dispose it as a
medical waste.
SIDE EFFECTS
It should not be used on patients allergic to any of the
ingredients.
CHEMICAL COMPOSITION
Content of the solution used in the Actolind® w Swab:
Name Concentration (w/w)
Isopropyl Alcohol
62,8%
Ethanol 3%
Clorhexidine Gluconate 2%
PHMB
0,05%
Actolind® w Mouth
For the treatment of mucosal infections of the mouth and
mouth ulcers. For oral hygiene before, during and after
dental and oral surgery.
• Actolind® w Mouth has a fresh mint flavor and is sugar free. Freshens instantly and deodorizes.
• Alcohol free formula kills germs that cause foul breath, plaque and the gum disease gingivitis.
• It prevents the formation of microorganisms and pathogenic microbes when the mouth is dry.
• Actolind® w Mouth is antiseptic and keeps the oral
area moisturized. It prevents and reduces the formation
of bacteria and microorganisms.
• Suitable for daily use.
• Minty taste refreshes the mouth. It is not toxic and irritant. Does not cause any pain.
WARNINGS
• Only for topical application. Store it under 25°C and out
of the reach of children.
• Do not use it if the seal under the cap is torn or broken.
• Shelf life is three (3) years at room temperature.
-9-
REFERENCES
REFERENCES
15. Kramer A, Roth B, Müller G et al. Influence of the antiseptic
agents polihexanide and octenidine on FL-cells and on healing
of experimental superficial aseptic wounds in piglets. A doubleblind, randomised, stratified controlled, parallel-group study.
Skin Pharmacol Physiol; 17:141–6, 2004.
16. Kramer A, Hübner N. O., Weltmann K. D., Lademann J.,
Ekkernkamp A., Hin P. and Ojan Assadian. Polypragmasia in
the therapy of infected wounds conclusions drawn from the
perspectives of low temperature plasma technology for plasma
wound therapy. GMS Krankenhaushygiene Interdisziplinär, Vol.
3(1), 2008.
17. Daeschlein G., Assadian O., Bruck J.C., Meinl C., Kramer A.
and S. Koch. Feasibility and Clinical Applicability of Polihexanide
for Treatment of Second-Degree Burn Wounds. Skin Pharmacol
Physiol;20:292–296 2007.
18. Müller G, Kramer A. Effect of selected wound antiseptics on
adult articular cartilage (bovine sesamoid bone) in the presence
of Escherichia coli and Staphylococcus aureus. J Orthopaed
Res.;23:127-33 2005.
19. Müller G, Kramer A. In vitro action of combinations of
selected antimicrobial agents and adult bovine cartilage (bovine
sesamoid bone). Chem Biol Interact;145:331-6, 2003.
20. Müller G, Kramer A. In vitro action of a combination of
selected antimicrobial agents and chondroitin sulfate. Chem
Biol Interact;124:77-85 2000.
21. Effect of polyhexanide and gentamicin on human osteoblasts
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22. Chemico-Biological Interactions 124 (2000) 77–85
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