PEDITRACE CONCENTRATE FOR PARENTERAL 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

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

A12CX

ATC Item Name

其它矿物质药物

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS KABI (SINGAPORE) PTE LTD

Manufacturers

FRESENIUS KABI NORGE AS

Active Ingredients

Ingredient Name

POTASSIUM IODIDE

Strength

1.31 mcg/ml

Drug MonographPotassium Iodide

Ingredient Name

SODIUM FLUORIDE

Strength

126 mcg/ml

Drug MonographSodium fluoride

Ingredient Name

COPPER CHLORIDE DIHYDRATE

Strength

53.7 mcg/ml

Drug MonographSodium phosphate, monobasic

Ingredient Name

MANGANESE CHLORIDE TETRAHYDRATE

Strength

3.6 mcg/ml

Drug MonographManganese

Ingredient Name

ZINC CHLORIDE

Strength

521 mcg/ml

Drug MonographZinc chloride

Ingredient Name

SODIUM SELENITE ANHYDROUS

Strength

4.38 mcg/ml

Drug MonographSelenious acid

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