CLINIMIX And CLINIMIX E Injections

Transcription

CLINIMIX And CLINIMIX E Injections
CLINIMIX
And CLINIMIX E
Injections
Nutrient Profile
INDICATIONS
CLINIMIX sulfite-free (Amino Acid in Dextrose)
Injections and CLINIMIX E sulfite-free (Amino
Acid with Electrolytes in Dextrose with Calcium)
Injections are indicated as a caloric component in
a parenteral nutrition regimen and as the protein
(nitrogen) source for offsetting nitrogen loss or
for the treatment of negative nitrogen balance in
patients where:
(1) the alimentary tract cannot or should not
be used,
(2) gastrointestinal absorption of protein is
impaired, or
(3) metabolic requirements for protein are
substantially increased, as with extensive burns.
Please see Important Risk Information on inside page
Please see accompanying Package Inserts for
Full Prescribing Information
To Mix Solutions
1G
rasp the container firmly on
each side of the top of the bag
(hanger end).
2R
oll the bag to open seal between
chambers as shown.
3 Mix solutions thoroughly.
4 Check for leaks.
SELECTED IMPORTANT RISK INFORMATION
Because of the potential for life-threatening events, caution
should be taken to ensure that precipitates have not formed in
any parenteral nutrient admixture.
With Vertical Peel Seal CLARITY Dual
Chamber Container in 1 L and 2 L sizes
* without additives
Clinimix sulfite-free (Amino Acid in Dextrose) and Clinimix E sulfite-free (Amino Acid with
Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 1-Liter Container
1
Product
Final concentrations
AFTER mixing.
liter
+
+
+
+
Total Volume (without lipids)
Amino Acid Concentration
Dextrose Concentration
gm Dextrose/L
gm Amino Acids/L
gm Nitrogen/L
Sodium (mEq/L)
Potassium (mEq/L)
Magnesium (mEq/L)
Calcium (mEq/L)
Acetate (mEq/L)
Chloride (mEq/L)
Phosphate (as HPO4 = ) (mmol/L)
pH*
Osmolarity (mOsmol/L)
Kcal from Amino Acids/L
Kcal from Dextrose/L
Total Kcal/L
Total Kcal with IV Fat Emulsion added**
20% 500 mL (1000 Kcal)
20% 250 mL (500 Kcal)
10% 500 mL (550 Kcal)
10% 250 mL (275 Kcal)
* pH Range = 4.5-7.0 ** Data on file, Baxter Healthcare Corporation.
CLINIMIX Inj.
2B7725
2.75/5
CLINIMIX Inj.
2B7726
4.25/5
CLINIMIX Inj.
2B7727
4.25/10
CLINIMIX Inj.
2B7728
4.25/20
CLINIMIX Inj.
2B7729
4.25/25
CLINIMIX Inj.
2B7730
5/15
1-Liter
2.75%
5%
50
27.5
4.54
----24
11
-6.0
525
110
170
280
1-Liter
4.25%
5%
50
42.5
7.02
----37
17
-6.0
675
170
170
340
1-Liter
4.25%
10%
100
42.5
7.02
----37
17
-6.0
930
170
340
510
1-Liter
4.25%
20%
200
42.5
7.02
----37
17
-6.0
1435
170
680
850
1-Liter
4.25%
25%
250
42.5
7.02
----37
17
-6.0
1685
170
850
1020
1-Liter
5%
15%
150
50
8.26
----42
20
-6.0
1255
200
510
710
1280
780
830
555
1340
840
890
615
1510
1010
1060
785
1850
1350
1400
1125
2020
1520
1570
1295
1710
1210
1260
985
Please see accompanying Package Insert for full Prescribing Information
CLINIMIX Inj.
2B7731
5/20
CLINIMIX Inj.
2B7732
5/25
CLINIMIX E Inj.
2B7735
2.75/5
CLINIMIX E Inj.
2B7736
2.75/10
CLINIMIX E Inj.
2B7737
4.25/5
CLINIMIX E Inj.
2B7738
4.25/10
CLINIMIX E Inj. CLINIMIX E Inj.
2B7739
2B7740
4.25/25
5/15
1-Liter
5%
20%
200
50
8.26
----42
20
-6.0
1505
200
680
880
1-Liter
5%
25%
250
50
8.26
----42
20
-6.0
1760
200
850
1050
1-Liter
2.75%
5%
50
27.5
4.54
35
30
5
4.5
51
39
15
6.0
665
110
170
280
1-Liter
2.75%
10%
100
27.5
4.54
35
30
5
4.5
51
39
15
6.0
920
110
340
450
1-Liter
4.25%
5%
50
42.5
7.02
35
30
5
4.5
70
39
15
6.0
815
170
170
340
1-Liter
4.25%
10%
100
42.5
7.02
35
30
5
4.5
70
39
15
6.0
1070
170
340
510
1-Liter
4.25%
25%
250
42.5
7.02
35
30
5
4.5
70
39
15
6.0
1825
170
850
1020
1880
1380
1430
1155
2050
1550
1600
1325
1280
780
830
555
1450
950
1000
725
1340
840
890
615
1510
1010
1060
785
2020
1520
1570
1295
CLINIMIX E Inj.
2B7741
5/20
CLINIMIX E Inj.
2B7742
5/25
1-Liter
5%
15%
150
50
8.26
35
30
5
4.5
80
39
15
6.0
1395
200
510
710
1-Liter
5%
20%
200
50
8.26
35
30
5
4.5
80
39
15
6.0
1650
200
680
880
1-Liter
5%
25%
250
50
8.26
35
30
5
4.5
80
39
15
6.0
1900
200
850
1050
1710
1210
1260
985
1880
1380
1430
1155
2050
1550
1600
1325
CLINIMIX SULFITE-FREE (AMINO ACID IN DEXTROSE) AND
CLINIMIX E SULFITE-FREE (AMINO ACID WITH ELECTROLYTES
IN DEXTROSE WITH CALCIUM) INJECTIONS
IMPORTANT RISK INFORMATION
• It is essential that a carefully prepared protocol based
on current medical practices be followed, preferably
by an experienced team. Frequent clinical evaluation
and laboratory determinations are necessary for proper
monitoring during administration.
• CLINIMIX and CLINIMIX E Injections are contraindicated in patients
having intracranial or intraspinal hemorrhage, in patients who
are severely dehydrated, in patients hypersensitive to one or
more amino acids and in patients with severe liver disease or
hepatic coma. Solutions containing corn-derived dextrose may
be contraindicated in patients with known allergy to corn or corn
products.
• Because of the potential for life-threatening events, caution should
be taken to ensure that precipitates have not formed in any
parenteral nutrient admixture.
• Use with caution when administering to patients with anuria or
renal insufficiency, pulmonary insufficiency, or heart disease. The
intravenous administration of these solutions can cause fluid and/
or solute overloading resulting in dilution of serum electrolyte
concentrations, overhydration, congested states, or pulmonary
edema.
• Metabolic complications have been reported, such as acid-base,
electrolyte, and blood glucose imbalances, elevated liver enzymes,
and osmotic diuresis and dehydration.
• Other adverse reactions that may occur include febrile response,
infection at the site of injection, extravasation, and hypervolemia.
The infusion of hypertonic nutrient injections into a peripheral vein
may result in vein irritation, vein damage, and thrombosis.
• This product contains aluminum that may be toxic with prolonged
parenteral administration if kidney function is impaired.
• CLINIMIX and CLINIMIX E Injections must be admixed prior to
infusion.
Please see accompanying Package Insert for full
Prescribing Information
Clinimix sulfite-free (Amino Acid in Dextrose) and Clinimix E sulfite-free (Amino Acid with
Electrolytes in Dextrose with Calcium) Injections Nutritional Profile: Nutrients per 2-Liter Container
2
Product
Final concentrations
AFTER mixing.
liter
+
+
+
+
Total Volume (without lipids)
Amino Acid Concentration
Dextrose Concentration
gm Dextrose/2 L
gm Amino Acids/2 L
gm Nitrogen/2 L
Sodium (mEq/2 L)
Potassium (mEq/2 L)
Magnesium (mEq/2 L)
Calcium (mEq/2 L)
Acetate (mEq/2 L)
Chloride (mEq/2 L)
Phosphate (as HPO4 = ) (mmol/2 L)
pH*
Osmolarity (mOsmol/L)
Kcal from Amino Acids/2 L
Kcal from Dextrose/2 L
Total Kcal/2 L
Total Kcal with IV Fat Emulsion added**
20% 500 mL (1000 Kcal)
20% 250 mL (500 Kcal)
10% 500 mL (550 Kcal)
10% 250 mL (275 Kcal)
* pH Range = 4.5-7.0 ** Data on file, Baxter Healthcare Corporation.
CLINIMIX Inj.
2B7704
4.25/5
CLINIMIX Inj.
2B7705
4.25/10
CLINIMIX Inj.
2B7706
4.25/20
CLINIMIX Inj.
2B7707
4.25/25
CLINIMIX Inj.
2B7709
5/15
CLINIMIX Inj.
2B7710
5/20
2-Liter
4.25%
5%
100
85
14.04
----74
34
-6.0
675
340
340
680
2-Liter
4.25%
10%
200
85
14.04
----74
34
-6.0
930
340
680
1020
2-Liter
4.25%
20%
400
85
14.04
----74
34
-6.0
1435
340
1360
1700
2-Liter
4.25%
25%
500
85
14.04
----74
34
-6.0
1685
340
1700
2040
2-Liter
5%
15%
300
100
16.52
----84
40
-6.0
1255
400
1020
1420
2-Liter
5%
20%
400
100
16.52
----84
40
-6.0
1505
400
1360
1760
1680
1180
1230
955
2020
1520
1570
1295
2700
2200
2250
1975
3040
2540
2590
2315
2420
1920
1970
1695
2760
2260
2310
2035
Please see accompanying Package Insert for full Prescribing Information
C
CLINIMIX Inj.
2B7711
5/25
CLINIMIX E Inj.
2B7713
2.75/5
CLINIMIX E Inj.
2B7714
2.75/10
CLINIMIX E Inj.
2B7716
4.25/5
CLINIMIX E Inj.
2B7717
4.25/10
CLINIMIX E Inj.
2B7719
4.25/25
CLINIMIX E Inj.
2B7721
5/15
CLINIMIX E Inj.
2B7722
5/20
CLINIMIX E Inj.
2B7723
5/25
2-Liter
5%
25%
500
100
16.52
----84
40
-6.0
1760
400
1700
2100
2-Liter
2.75%
5%
100
55
9.08
70
60
10
9
102
78
30
6.0
665
220
340
560
2-Liter
2.75%
10%
200
55
9.08
70
60
10
9
102
78
30
6.0
920
220
680
900
2-Liter
4.25%
5%
100
85
14.04
70
60
10
9
140
78
30
6.0
815
340
340
680
2-Liter
4.25%
10%
200
85
14.04
70
60
10
9
140
78
30
6.0
1070
340
680
1020
2-Liter
4.25%
25%
500
85
14.04
70
60
10
9
140
78
30
6.0
1825
340
1700
2040
2-Liter
5%
15%
300
100
16.52
70
60
10
9
160
78
30
6.0
1395
400
1020
1420
2-Liter
5%
20%
400
100
16.52
70
60
10
9
160
78
30
6.0
1650
400
1360
1760
2-Liter
5%
25%
500
100
16.52
70
60
10
9
160
78
30
6.0
1900
400
1700
2100
3100
2600
2650
2375
1560
1060
1110
835
1900
1400
1450
1175
1680
1180
1230
955
2020
1520
1570
1295
3040
2540
2590
2315
2420
1920
1970
1695
2760
2260
2310
2035
3100
2600
2650
2375
For more information, contact Medical Information
at 1-800-422-2751 or visit
www.baxtermedicationdeliveryproducts.com
Please see Important Risk Information on inside page
Please see accompanying Package Inserts for Full Prescribing Information
www.baxter.com
Baxter Healthcare Corporation
Route 120 and Wilson Road
Round Lake, IL 60073
Baxter, Clarity, Clinimix, Clinimix E, the Clinimix logo are trademarks of
Baxter International Inc.
USMP/78/14-0004
3/14

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