SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE 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

Prescription Only

HSA Singapore Classification

Formulation Information

Dosage Form

INJECTION, EMULSION

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, Site Uppsala

Active Ingredients

Ingredient Name

Soy-bean oil, refined

Strength

8.7g/1000ml

Drug MonographSoybean oil

Ingredient Name

Glucose monohydrate eqv. glucose

Strength

85g/1000ml

Drug MonographGlucose

Ingredient Name

Taurine

Strength

0.65g/1000ml

Drug MonographTaurine

Ingredient Name

L-Methionine

Strength

2.8g/1000ml

Drug MonographMethionine

Ingredient Name

L-Serine

Strength

4.3g/1000ml

Drug MonographSerine

Ingredient Name

L-Tryptophan

Strength

1.3g/1000ml

Drug MonographTryptophan

Ingredient Name

L-Isoleucine

Strength

3.3g/1000ml

Drug MonographIsoleucine

Ingredient Name

Triglycerides, medium-chain

Strength

8.7g/1000ml

Drug MonographMedium-chain triglycerides

Ingredient Name

Glycine

Strength

7.2g/1000ml

Drug MonographGlycine

Ingredient Name

Fish oil, rich in omega-3 acids

Strength

4.3g/1000ml

Drug MonographFish oil

Ingredient Name

L-Lysine acetate eqv. L-Lysine

Strength

4.3g/1000ml

Drug MonographLysine

Ingredient Name

L-Phenylalanine

Strength

3.3g/1000ml

Drug MonographPhenylalanine

Ingredient Name

L-Valine

Strength

4.1g/1000ml

Drug MonographValine

Ingredient Name

L-Tyrosine

Strength

0.26g/1000ml

Drug MonographTyrosine

Ingredient Name

Olive oil, refined

Strength

7.2g/1000ml

Drug MonographOlive oil

Ingredient Name

L-Arginine

Strength

7.9g/1000ml

Drug MonographL-arginine

Ingredient Name

L-Histidine

Strength

2g/1000ml

Drug MonographHistidine

Ingredient Name

L-Alanine

Strength

9.2g/1000ml

Drug MonographAlanine

Ingredient Name

L-Threonine

Strength

2.9g/1000ml

Drug MonographThreonine

Ingredient Name

L-Leucine

Strength

4.8g/1000ml

Drug MonographLeucine

Ingredient Name

L-Proline

Strength

7.3g/1000ml

Drug MonographProline

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