PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantBAXTER HEALTHCARE (ASIA) PTE LTD

Licence HolderBAXTER HEALTHCARE (ASIA) PTE LTD

Product Classification

Drug Type

Therapeutic

Forensic Class

General Sale List

HSA Singapore Classification

Formulation Information

Dosage Form

INJECTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

B05BA01

ATC Item Name

amino acids

Manufacturer Information

Pharmaceutical Manufacturer

BAXTER HEALTHCARE (ASIA) PTE LTD

Manufacturers

BIEFFE MEDITAL S.P.A.

Active Ingredients

Ingredient Name

L-SERINE

Strength

4 g/l

Drug MonographSerine

Ingredient Name

L-TRYPTOPHAN

Strength

2 g/l

Drug MonographTryptophan

Ingredient Name

GLYCINE

Strength

4 g/l

Drug MonographGlycine

Ingredient Name

L-GLUTAMIC ACID

Strength

10 g/l

Drug MonographGlutamic acid

Ingredient Name

L-PHENYLALANINE

Strength

4.2 g/l

Drug MonographPhenylalanine

Ingredient Name

TAURINE

Strength

0.6 g/l

Drug MonographTaurine

Ingredient Name

L-LYSINE

Strength

11 g/l

Drug MonographLysine

Ingredient Name

L-METHIONINE

Strength

2.4 g/l

Drug MonographMethionine

Ingredient Name

L-TYROSINE

Strength

0.45 g/l

Drug MonographTyrosine

Ingredient Name

L-VALINE

Strength

7.6 g/l

Drug MonographValine

Ingredient Name

L-ISOLEUCINE

Strength

6.7 g/l

Drug MonographIsoleucine

Ingredient Name

L-PROLINE

Strength

3 g/l

Drug MonographProline

Ingredient Name

L-THREONINE

Strength

3.7 g/l

Drug MonographThreonine

Ingredient Name

L-ALANINE

Strength

8 g/l

Drug MonographAlanine

Ingredient Name

L-HISTIDINE

Strength

3.8 g/l

Drug MonographHistidine

Ingredient Name

L-ARGININE

Strength

8.4 g/l

Drug MonographL-arginine

Ingredient Name

L-CYSTEINE

Strength

1.89 g/l

Drug MonographCysteine

Ingredient Name

L-ORNITHINE HYDROCHLORIDE

Strength

3.18 g/l

Drug MonographOrnithine

Ingredient Name

L-ASPARTIC ACID

Strength

6 g/l

Drug MonographAspartic acid

Ingredient Name

L-LEUCINE

Strength

10 g/l

Drug MonographLeucine

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Active Ingredients

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