BERIPLEX P/N 1000 1240 UNIT
COAGULATION FACTOR IX (HUMAN) : 1240 UNIT COAGULATION FACTOR II (HUMAN) : 1600 UNIT COAGULATION FACTOR VII (HUMAN) : 1000 UNIT PROTEIN S : 1360 UNIT PROTEIN C : 1640 UNIT COAGULATION FACTOR X (HUMAN) : 2040 UNIT · DIN 02410826 · CSL BEHRING CANADA INC
Health Canada status: MARKETED
What is BERIPLEX P/N 1000?
BERIPLEX P/N 1000 1240 UNIT contains COAGULATION FACTOR IX (HUMAN) : 1240 UNIT COAGULATION FACTOR II (HUMAN) : 1600 UNIT COAGULATION FACTOR VII (HUMAN) : 1000 UNIT PROTEIN S : 1360 UNIT PROTEIN C : 1640 UNIT COAGULATION FACTOR X (HUMAN) : 2040 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02410826, held by CSL BEHRING CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 21-Nov-2013. 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 BERIPLEX P/N 1000 used for?
Beriplex® P/N (Human prothrombin complex) is indicated in adults (≥ 18 years of age) for the treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. Beriplex® P/N can be used for the treatment of bleeding and perioperative prophylaxis of bleeding in congenital deficiency of any of the vitamin K dependent coagulation factors only if purified specific coagulation factor product is not available.
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 | 02410826 |
|---|---|
| Brand name | BERIPLEX P/N 1000 |
| Generic / active ingredient | COAGULATION FACTOR IX (HUMAN) : 1240 UNIT COAGULATION FACTOR II (HUMAN) : 1600 UNIT COAGULATION FACTOR VII (HUMAN) : 1000 UNIT PROTEIN S : 1360 UNIT PROTEIN C : 1640 UNIT COAGULATION FACTOR X (HUMAN) : 2040 UNIT |
| Manufacturer | CSL BEHRING CANADA INC |
| Strength | 1240 UNIT |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | B02BD01 COAGULATION FACTOR IX, II, VII AND X IN COMB |
| AHFS class | 28:16.04.20 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 21-Nov-2013 |
How is it administered?
Individualized dose based on INR and body weight (up to 100kg). Administer IV at max 3 IU/kg/min (max 210 IU/min). Administer Vitamin K concurrently.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
See section 11 Storage, Stability, and Disposal for the recommended storage period and conditions. If not administered immediately, storage shall not exceed 3 hours at room temperature.
How is it supplied?
Beriplex ® P/N 500: 500 IU Factor IX/vial with 20 mL solvent; Beriplex ® P/N 1000: 1000 IU factor IX/vial with 40 mL solvent. Each package includes a needle-less filter transfer device Mix2Vial®.
Contraindications
Hypersensitivity to active substance or excipients; disseminated intravascular coagulation (until consumptive state ends); known history of heparin-induced thrombocytopenia.
Warnings and precautions
Risk of thrombosis and DIC. Monitor for thromboembolic events. Risk of transmitting infectious agents (human plasma-derived). Contains heparin (risk of HIT).
What can be used instead?
Other Canadian products sharing ATC code B02BD01 COAGULATION FACTOR IX, II, VII AND X IN COMB. 4 of 4 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 |
|---|---|---|---|---|---|
| BERIPLEX P/N 500 | 680 UNIT | POWDER FOR SOLUTION | CSL BEHRING CANADA INC | MARKETED | DIN 02359251 |
| OCTAPLEX | 1240 UNIT | POWDER FOR SOLUTION ; KIT | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | MARKETED | DIN 02434970 |
| OCTAPLEX | 480 UNIT | KIT ; POWDER FOR SOLUTION | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | MARKETED | DIN 02294664 |
Who else supplies COAGULATION FACTOR IX, II, VII AND X IN COMB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. COAGULATION FACTOR IX, II, VII AND X IN COMB 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.