NIASTASE RT 1 MG
EPTACOG ALFA (ACTIVATED) : 1 MG · DIN 02417103 · NOVO NORDISK CANADA INC
Health Canada status: MARKETED
What is NIASTASE RT?
NIASTASE RT 1 MG contains EPTACOG ALFA (ACTIVATED) : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 02417103, held by NOVO NORDISK CANADA INC, supplied as POWDER FOR SOLUTION ; KIT for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 05-May-2015. 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 NIASTASE RT used for?
Treatment of bleeding episodes in hemophilia A/B with inhibitors, Glanzmann’s thrombasthenia, acquired hemophilia, and congenital Factor VII deficiency. Prevention of bleeding in surgery.
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 | 02417103 |
|---|---|
| Brand name | NIASTASE RT |
| Generic / active ingredient | EPTACOG ALFA (ACTIVATED) : 1 MG |
| Manufacturer | NOVO NORDISK CANADA INC |
| Strength | 1 MG |
| Dosage form | POWDER FOR SOLUTION ; KIT |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02BD08 COAGULATION FACTOR VIIa |
| AHFS class | 20:28.16 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 05-May-2015 |
| Original market date | 2015-05-05 00:00:00 |
How is it administered?
Administered by intravenous bolus injection. Dosage varies by indication (hemophilia A/B with inhibitors, Glanzmann’s thrombasthenia, acquired hemophilia, or Factor VII deficiency).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Room temperature stable (implied by name and context, though specific range not in snippet, usually up to 25°C or 30°C).
How is it supplied?
Vials of 1.0 mg (50 KIU), 2.0 mg (100 KIU), 5.0 mg (250 KIU), and 8.0 mg (400 KIU). Solvent for reconstitution contains histidine.
Contraindications
Known hypersensitivity to the active substance, excipients, or to mouse, hamster or bovine protein.
Warnings and precautions
Risk of arterial and venous thromboembolic events. Fatal outcomes reported in off-label use. Monitor for DIC and antibody formation in Factor VII deficient patients.
What can be used instead?
Other Canadian products sharing ATC code B02BD08 COAGULATION FACTOR VIIa. 3 of 11 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 |
|---|---|---|---|---|---|
| NIASTASE RT | 2 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | MARKETED | DIN 02417111 |
| NIASTASE RT | 5 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | MARKETED | DIN 02417138 |
| NIASTASE | 1.2 MG | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | CANCELLED POST MARKET | DIN 02239659 |
| NIASTASE | 2.4 MG | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | CANCELLED POST MARKET | DIN 02239660 |
| NIASTASE | 4.8 MG | POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | CANCELLED POST MARKET | DIN 02239661 |
| NIASTASE RT | 1 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02347113 |
| NIASTASE RT | 2 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02347121 |
| NIASTASE RT | 5 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02347148 |
| NIASTASE RT | 8 MG | KIT ; POWDER FOR SOLUTION | NOVO NORDISK CANADA INC | APPROVED | DIN 02365669 |
| NIASTASE RT | 8 MG | POWDER FOR SOLUTION ; KIT | NOVO NORDISK CANADA INC | APPROVED | DIN 02417146 |
Who else supplies COAGULATION FACTOR VIIa worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. COAGULATION FACTOR VIIa 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.