MAL09011450AZPrescription (MAL-A)

STAY SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag

Generic Molecule: Magnesium Chloride Hexahydrate Pheur

ACTIVE & APPROVEDValid till: 1 Feb 2029
NPRA Official Regulatory Summary

STAY SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag is a KKM-approved Prescription Medicine registered under MAL number MAL09011450AZ by FRESENIUS MEDICAL CARE MALAYSIA SDN. BHD.. Its active ingredient is magnesium chloride hexahydrate PhEur 0.2033 g 1000 ml, Sodium Lactate Solution (50%) 15.69 g 1000 ml, glucose monohydrate, Ph Eur 50.00 g 1000 ml, Sodium Chloride (NaCl) 11.279 g 1000 ml, calcium chloride dihydrate Ph. Eur. 0.3675 g 1000 ml, manufactured by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH.

Holder (PRH)
FRESENIUS MEDICAL CARE MALAYSIA SDN. BHD.
Manufacturer
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
First Registered
1 Feb 2024
Validity
1 Feb 2029

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

6 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
magnesium chloride hexahydrate PhEur0.2033 g 1000 mlFind Brands
Sodium Lactate Solution (50%)15.69 g 1000 mlFind Brands
glucose monohydrateFormulation ProprietaryFind Brands
Ph Eur50.00 g 1000 mlFind Brands
Sodium Chloride (NaCl)11.279 g 1000 mlFind Brands
calcium chloride dihydrate Ph. Eur.0.3675 g 1000 mlFind Brands
Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Sole Registered Brand Formulation

This product is currently the primary or innovator formulation registered in Malaysia under Magnesium Chloride Hexahydrate Pheur.

Malaysian KKM Security Hologram Verification

FarmaChecker & Meditag™

By Malaysian Ministry of Health (KKM) regulation, all genuine registered pharmaceuticals, health supplements (MAL-N), and traditional products (MAL-T) distributed in Malaysia must feature an official tamper-evident security hologram sticker on the physical packaging.

1. Visual Tilt Check

Tilt the box under light to view the micro-engraved KKM coat of arms and multi-layer iridescent security patterns.

2. Match MAL Number

Ensure the printed MAL code matches MAL09011450AZ exactly on label and box.

3. FarmaChecker Scan

Scan using the official FarmaChecker app on iOS / Android to authenticate serial token with NPRA servers.

If the packaging lacks a security hologram or fails the FarmaChecker scan, do not consume and report to Cawangan Penguatkuasaan Farmasi (CPF KKM).
Frequently Asked Questions & Verification Details

Is STAY SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag approved by KKM / NPRA?

Yes. STAY SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL09011450AZ with current status PRODUCT APPROVED. Registration was filed by FRESENIUS MEDICAL CARE MALAYSIA SDN. BHD..

What are the active ingredients of STAY SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag?

The declared active therapeutic components are: magnesium chloride hexahydrate PhEur 0.2033 g 1000 ml, Sodium Lactate Solution (50%) 15.69 g 1000 ml, glucose monohydrate, Ph Eur 50.00 g 1000 ml, Sodium Chloride (NaCl) 11.279 g 1000 ml, calcium chloride dihydrate Ph. Eur. 0.3675 g 1000 ml. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 1 registered brand formulations containing identical active ingredients (Magnesium Chloride Hexahydrate Pheur). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: STAY SAFE BALANCE 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution bag (MAL09011450AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.