Adynovate Description

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

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Full Prescribing Info

Description

ADYNOVATE 500 IU/2 ml powder and solvent for solution for injection: Powder: White to off-white friable powder.
Solvent: Clear and colourless solution.
Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
The potency (International Units) is determined using the chromogenic assay. The specific activity of ADYNOVATE is approximately 2,700-8,000 IU/mg protein. The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
* Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Excipient(s) with known effect: Each powder vial contains 0.45 mmol (10 mg) sodium, see Precautions.
Excipients/Inactive Ingredients: Powder: Mannitol, Trehalose dihydrate, Histidine, Glutathione, Sodium chloride, Calcium chloride dihydrate, Tris(hydroxymethyl)aminomethane, Polysorbate 80.
Solvent: Sterilised water for injections.

factor viii

Manufacturer:

Takeda

Distributor:

Zuellig Pharma

Marketer:

Takeda