BALANCE 2.3% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION (CAPD 19 FORMULATION)

Approval Number

SIN13266P

Drug Name

Product Name

BALANCE 2.3% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION (CAPD 19 FORMULATION)

Approval Date

May 2, 2007

Registrant

FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Licence Holder

FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Licence HolderFRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Product Classification

Drug Type

Therapeutic

Forensic Class

General Sale List

HSA Singapore Classification

Formulation Information

Dosage Form

SOLUTION, STERILE

Route of Administration

INTRAPERITONEAL

Medical Information

ATC Code

B05DA

ATC Item Name

等渗溶液

Manufacturer Information

Pharmaceutical Manufacturer

FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Manufacturers

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

FRESENIUS MEDICAL CARE JAPAN K.K. (BUZEN PLANT)

Active Ingredients

Ingredient Name

MAGNESIUM CHLORIDE (6H₂O)

Strength

0.1017 G/L

Drug MonographMagnesium chloride

Ingredient Name

SODIUM S-LACTATE SOLUTION 50% (=SODIUM S-LACTATE )

Strength

3.925 G/L

Drug Monograph

sodium s-lactate solution 50% (=sodium s-lactate )

Ingredient Name

SODIUM CHLORIDE

Strength

5.640 G/L

Drug MonographSodium chloride

Ingredient Name

CALCIUM CHLORIDE (2H₂O)

Strength

0.1838 G/L

Drug MonographCalcium chloride

Ingredient Name

GLUCOSE MONOHYDRATE

Strength

25 G/L

Drug MonographGlucose

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BALANCE 2.3% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION (CAPD 19 FORMULATION)

Regulatory Information

Regulatory Responsibility

Product Classification

Formulation Information

Medical Information

Manufacturer Information

Active Ingredients

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