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HSA Product

OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU

Product approved by Health Sciences Authority (SG)

Basic Information

OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU

INJECTION, POWDER, FOR SOLUTION

Regulatory Information

SIN14933P

January 28, 2016

Prescription Only

Therapeutic

INTRAVENOUS DRIP

August 10, 2023

June 3, 2025

XB02BD01

Company Information

WELLCHEM PHARMACEUTICALS PTE LTD

WELLCHEM PHARMACEUTICALS PTE LTD

Active Ingredients

Factor II

Strength: 280 - 760 IU/vial

Factor VII

Strength: 180 - 480 IU/vial

Factor IX

Strength: 500 IU/vial

Factor X

Strength: 360 - 600 IU/vial

Protein S

Strength: 240 - 640 IU/vial

Protein C

Strength: 260 - 620 IU/vial

Detailed Information

Contraindications

**4.3 Contraindications** - Hypersensitivity to the active substance or to any of the excipients. - Known allergy to heparin or history of heparin induced thrombocytopenia. - Individuals who have IgA deficiency with known antibodies against IgA.

Indication Information

**4.1 Therapeutic indications** - Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.

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