Overview

JIVI 1000 UNIT contains ANTIHEMOPHILIC FACTOR (RECOMBINANT, B-DOMAIN DELETED, PEGYLATED) : 1000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02481774, held by BAYER INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Nexara Health is a licensed Canadian wholesale distributor and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

Product details

Indications

Routine prophylaxis, control/prevention of episodic bleeding, and peri-operative management in previously treated adults, adolescents, and children (7+ years) with hemophilia A.

Dosage and administration

Individualize dose based on weight and FVIII levels. Prophylaxis (Adults/Adolescents): 30-40 IU/kg twice weekly. Children (7-12y): 60 IU/kg twice weekly. Max dose ~6000 IU per infusion.

Contraindications

Hypersensitivity to the drug, any ingredient in the formulation, or component of the container; prior anaphylactic reaction to mouse or hamster protein.

Warnings and precautions

Risk of anti-PEG antibodies leading to loss of efficacy or hypersensitivity (especially in children); risk of FVIII inhibitor formation; potential for anaphylaxis.

Storage and handling

Not explicitly detailed in the provided text snippet (section 11 header exists but content is missing), though reconstitution instructions mention not exceeding 37°C.

Packaging

Single-use vials (500, 1000, 2000, 3000 IU) with 2.5 mL Sterile Water for Injection in a prefilled syringe and a vial adapter.

Alternatives in the same therapeutic class

Products sharing ATC code B02BD02 COAGULATION FACTOR VIII. Marketed products are listed first. Substitution decisions rest with the prescriber or pharmacist, and interchangeability is determined provincially.