KOGENATE FS 1000 UNIT
ANTIHEMOPHILIC FACTOR (RECOMBINANT) : 1000 UNIT · DIN 02242491 · BAYER INC
Health Canada status: CANCELLED POST MARKET
What is KOGENATE FS?
KOGENATE FS 1000 UNIT contains ANTIHEMOPHILIC FACTOR (RECOMBINANT) : 1000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02242491, held by BAYER INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 06-Aug-2009. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is KOGENATE FS used for?
Treatment of classical hemophilia (hemophilia A). Regular prophylactic treatment to prevent spontaneous hemorrhagic episodes and joint damage in children with no pre-existing joint damage.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02242491 |
|---|---|
| Brand name | KOGENATE FS |
| Generic / active ingredient | ANTIHEMOPHILIC FACTOR (RECOMBINANT) : 1000 UNIT |
| Manufacturer | BAYER INC |
| Strength | 1000 UNIT |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02BD02 COAGULATION FACTOR VIII |
| AHFS class | 20:28.16 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 06-Aug-2009 |
| Original market date | 2000-09-29 00:00:00 |
How is it administered?
Individualize dose based on FVIII deficiency severity, hemorrhage severity, and inhibitors. Administer IV within 3 hours of reconstitution. Prophylaxis in children: 25 IU/kg every other day.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store under refrigeration (2-8°C). Do not freeze. Protect from light. Reconstituted product must be used within 3 hours.
How is it supplied?
Vials of 250, 500, 1000, or 2000 IU with 2.5 mL or 5.0 mL Sterile Water for Injection (diluent), transfer device, filter needle, and administration set.
Contraindications
Hypersensitivity to the drug, any ingredient in the formulation, or component of the container. Known hypersensitivity to mouse or hamster protein.
Warnings and precautions
Development of circulating neutralizing antibodies (inhibitors) to FVIII may occur. Risk of serious anaphylactic reactions. Potential for hypersensitivity to mouse/hamster proteins.
What can be used instead?
Other Canadian products sharing ATC code B02BD02 COAGULATION FACTOR VIII. 38 of 134 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| ADYNOVATE | 1000 UNIT | KIT ; POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02498588 |
| ADYNOVATE | 1500 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | DIN 02498596 |
| ADYNOVATE | 2000 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | DIN 02459078 |
| ADYNOVATE | 250 UNIT | KIT ; POWDER FOR SOLUTION | TAKEDA CANADA INC | MARKETED | DIN 02498537 |
| ADYNOVATE | 3000 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | DIN 02498626 |
| ADYNOVATE | 500 UNIT | POWDER FOR SOLUTION ; KIT | TAKEDA CANADA INC | MARKETED | DIN 02498545 |
| ALTUVIIIO | 1000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02448130 |
| ALTUVIIIO | 2000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02448149 |
| ALTUVIIIO | 3000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02447967 |
| ALTUVIIIO | 4000 UNIT | POWDER FOR SOLUTION | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02448157 |
Who else supplies COAGULATION FACTOR VIII worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. COAGULATION FACTOR VIII appears in 109 registered pack listings across 5 markets, published on 3 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.