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Primene

Generic name: isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, aspartic acid, cysteine, glutamic acid, glycine, proline, serine, tyrosine, ornitine hydrchloride, taurine
Dosage form: injection, solution
Drug class: Intravenous nutritional products

Medically reviewed by Drugs.com. Last updated on Oct 22, 2020.

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

FCA3CG133R79D
Baxter Logo
Composition
Each one litre contains: g/l
L-Isoleucine 6.70 g
L-Leucine 10.00 g
L-Valine 7.60 g
L-Lysine 11.00 g
L-Methionine 2.40 g
L-Phenylalanine 4.20 g
L-Threonine 3.70 g
L-Tryptophan 2.00 g
L-Arginine 8.40 g
L-Histidine 3.80 g
L-Alanine 8.00 g
L-Aspartic Acid 6.00 g
L-Cysteine 1.89 g
L-Glutamic Acid 10.00 g
Glycine 4.00 g
L-Proline 3.00 g
L-Serine 4.00 g
L-Tyrosine 0.45 g
L-Ornithine hydrochloride 3.18 g
Taurine 0.60 g

Other constituents:
Malic Acid QS pH 5.5, Water for Injections QS 1000 ml

Total Nitrogen: 15 g/l
Amino acids: 100 g/l

Chlorides: 19 mmol/l
Osmolarity: 780 mOsm/l

Bar Code
5413760 473215

GR-65-01-515

Primene 10%

250 ml

Primene 10%

Solution for Infusion
For intravenous use

Use as directed by physician.
WARNING: Hypertonic solution. Do not infuse alone into a peripheral vein.
Do not exceed the recommended infusion rate.
Do not store above 25°C. Protect from light.
Single use only. Discard any partly-used containers.
Do not use unless the vacuum is present.
Do not use if the bottle is leaking or the solution is discolured, cloudy or contains a precipitate.
Check compatibility and stability of nutritive mixtures before use.
Keep out of sight and reach of children.

Baxter Healthcare Ltd., Caxton Way.
Thetford, Norfolk, IP24 3SE, UK
PL 0116/0283

POM symbol

Batch No:

Mfg. date:

Expiry date:

25/225
50/200
75/175
100/150

Primene
isoleucine, leucine, valine, lysine, methionine, phenylalanine, threonine, tryptophan, arginine, histidine, alanine, aspartic acid, cysteine, glutamic acid, glycine, proline, serine, tyrosine, ornitine hydrchloride, taurine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-9577
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 1.675 g in 250 mL
LEUCINE (LEUCINE) LEUCINE 2.5 g in 250 mL
VALINE (VALINE) VALINE 1.9 g in 250 mL
LYSINE (LYSINE) LYSINE 2.75 g in 250 mL
METHIONINE (METHIONINE) METHIONINE 0.6 g in 250 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 1.05 g in 250 mL
THREONINE (THREONINE) THREONINE 0.9 g in 250 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 0.5 g in 250 mL
ARGININE (ARGININE) ARGININE 2.1 g in 250 mL
HISTIDINE (HISTIDINE) HISTIDINE 0.95 g in 250 mL
ALANINE (ALANINE) ALANINE 2 g in 250 mL
ASPARTIC ACID (ASPARTIC ACID) ASPARTIC ACID 1.5 g in 250 mL
CYSTEINE (CYSTEINE) CYSTEINE 0.47 g in 250 mL
GLUTAMIC ACID (GLUTAMIC ACID) GLUTAMIC ACID 2.5 g in 250 mL
GLYCINE (GLYCINE) GLYCINE 1 g in 250 mL
PROLINE (PROLINE) PROLINE 0.75 g in 250 mL
SERINE (SERINE) SERINE 1 g in 250 mL
TYROSINE (TYROSINE) TYROSINE 0.11 g in 250 mL
ORNITHINE HYDROCHLORIDE (ORNITHINE) ORNITHINE 0.8 g in 250 mL
TAURINE (TAURINE) TAURINE 0.15 g in 250 mL
Inactive Ingredients
Ingredient Name Strength
MALIC ACID
Packaging
# Item Code Package Description
1 NDC:0338-9577-10 10 BAG in 1 CARTON
1 250 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 11/22/2017
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
BIEFFE MEDITAL SPA 514069459 ANALYSIS(0338-9577), MANUFACTURE(0338-9577), LABEL(0338-9577), PACK(0338-9577), STERILIZE(0338-9577)
Baxter Healthcare Corporation

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