Source: Health Products and Food Branch (CA) Revision Year: 2021
ELOCTATE – Antihemophilic Factor (Recombinant BDD), Fc Fusion Protein.
Lyophilized Powder for Solution 250, 500, 750, 1000, 1500, 2000 and 3000 IU/vial.
Antihemorrhagic Blood Coagulation Factor VIII.
Table 3. Dosage Forms, Strengths, Composition and Packaging:
| Route of Administration | Dosage Form / Strength/Composition | Non-medicinal Ingredients |
|---|---|---|
| Intravenous injection | Lyophilized powder nominally containing 250, 500, 750, 1000, 1500, 2000, and 3000 IU/vial. The reconstituted product contains: 83, 167, 250, 333, 500, 667 and 1000 IU/mL, respectively. | When reconstituted with provided diluent, the product contains calcium chloride dihydrate, Lhistidine, polysorbate 20, sodium chloride, sucrose |
Eloctate is formulated as a sterile, non-pyrogenic, preservative-free, lyophilized, white to off-white powder to cake, for intravenous administration in a single use vial. Liquid diluent (Sterile Water for Injection) for reconstitution is provided in a pre-filled syringe.
Each single-use vial contains nominally 250, 500, 750, 1000, 1500, 2000 or 3000 International Units (IU) of Eloctate. The diluent (sterile Water for Injection) is provided in a pre-filled syringe.
When reconstituted with provided diluent, the product contains sucrose, sodium chloride, L-histidine, calcium chloride dihydrate, and polysorbate 20.
Each carton of Eloctate contains a powder vial with a stopper and a flip-off seal, 3 mL diluent in a prefilled syringe with a plunger stopper, a tip-cap and a sterile vial adapter reconstitution device.
A carton containing 1 butterfly infusion set, 2 alcohol pads, 1 gauze pad, and 2 bandages is provided along with the drug product carton.
Dispose of all the materials of the packaging in accordance with local requirements.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
sanofi-aventis Canada Inc., 2905 Place Louis-R.-Renaud, Laval, Québec, H7V 0A3 247043 |
Date of approval:
August 22, 2014 November 8, 2021 |
| Drug | Countries | |
|---|---|---|
| ELOCTATE | Brazil, Canada, Hong Kong, Japan, New Zealand |
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