KABIVEN PERIPHERAL EMULSION FOR INFUSION

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD

Licence HolderFRESENIUS KABI (SINGAPORE) 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

B05BA10

ATC Item Name

combinations

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS KABI (SINGAPORE) PTE LTD

Manufacturers

FRESENIUS KABI AB

FRESENIUS KABI AUSTRIA GMBH

Active Ingredients

Ingredient Name

L-TRYPTOPHAN

Strength

0.4 g/l

Drug MonographTryptophan

Ingredient Name

GLUCOSE MONOHYDRATE EQV GLUCOSE (ANHYDROUS)

Strength

67.6 g/l

Drug MonographGlucose

Ingredient Name

AMINOACETIC ACID (GLYCINE)

Strength

1.6 g/l

Drug MonographGlycine

Ingredient Name

SODIUM GLYCEROPHOSPHATE (ANHYDROUS)

Strength

1.0 g/l

Drug MonographSodium glycerophosphate

Ingredient Name

L-GLUTAMIC ACID

Strength

1.2 g/l

Drug MonographGlutamic acid

Ingredient Name

L-LYSINE HCl EQV L-LYSINE

Strength

1.9 g/l

Drug MonographLysine

Ingredient Name

MAGNESIUM SULPHATE HEPTAHYDRATE

Strength

0.7 g/l

Drug MonographMagnesium gluconate

Ingredient Name

CALCIUM CHLORIDE DIHYDRATE

Strength

0.2 g/l

Drug MonographCalcium chloride

Ingredient Name

L-VALINE

Strength

1.5 g/l

Drug MonographValine

Ingredient Name

L-PHENYLALANINE

Strength

1.6 g/l

Drug MonographPhenylalanine

Ingredient Name

L-TYROSINE

Strength

0.05 g/l

Drug MonographTyrosine

Ingredient Name

L-SERINE

Strength

0.94 g/l

Drug MonographSerine

Ingredient Name

POTASSIUM CHLORIDE

Strength

1.2 g/l

Drug MonographPotassium chloride

Ingredient Name

L-METHIONINE

Strength

1.2 g/l

Drug MonographMethionine

Ingredient Name

L-ISOLEUCINE

Strength

1.2 g/l

Drug MonographIsoleucine

Ingredient Name

SOYABEAN OIL

Strength

35.0 g/l

Drug MonographSoybean oil

Ingredient Name

L-ASPARTIC ACID

Strength

0.71 g/l

Drug MonographAspartic acid

Ingredient Name

L-ALANINE

Strength

3.3 g/l

Drug MonographAlanine

Ingredient Name

L-LEUCINE

Strength

1.6 g/l

Drug MonographLeucine

Ingredient Name

L-ARGININE

Strength

2.4 g/l

Drug MonographL-arginine

Ingredient Name

L-PROLINE

Strength

1.4 g/l

Drug MonographProline

Ingredient Name

L-HISTIDINE

Strength

1.4 g/l

Drug MonographHistidine

Ingredient Name

L-THREONINE

Strength

1.2 g/l

Drug MonographThreonine

Ingredient Name

SODIUM ACETATE TRIHYDRATE

Strength

1.7 g/l

Drug MonographSodium acetate

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