Patient Medication Information: uses, side effects, how to take - Beriplex P/N 1000
Serious warnings and precautions box
What Beriplex® P/N 500/ Beriplex® P/N 1000 is used for:
- Treatment of bleeding and prevention of bleeding prior, during, or following surgery in patients with 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.
How Beriplex® P/N 500/ Beriplex® P/N 1000 works:
In normal individuals, damage to blood vessels trigger a cascade of events that activate specific proteins present in their blood and which are responsible for the formation of a clot that ultimately stops the bleeding.
In patients treated with vitamin K antagonists (e.g. Warfarin, Coumadin, etc., or heparins), damage to blood vessels does not trigger the full cascade of events leading to the formation of blood clots.
Beriplex® P/N is used to treat or prevent bleeding in these patients by providing adequate amounts of the necessary missing or inhibited factors required for normal blood coagulation.
The ingredients in Beriplex® P/N 500/ Beriplex® P/N 1000 are:
Medicinal ingredient(s): Beriplex® P/N is a lyophilized plasma protein preparation containing human plasma coagulation factors II, VII, IX and X, as well as protein C and protein S.
- The use of prothrombin complex concentrates is associated with the risk of thrombosis. Cases of thrombosis have been observed in conjunction with treatment with Beriplex® P/N.
Non-medicinal ingredients: Heparin, human albumin, human antithrombin III, sodium chloride, sodium citrate, HCl or NaOH (in small amount for pH adjustment).
For a full listing of non-medicinal ingredients see Part 1: Healthcare Professional Information of the product monograph.
Beriplex® P/N 500/ Beriplex® P/N 1000 comes in the following dosage form(s):
Beriplex® P/N is available in single use vials of either 500 IU or 1000 IU. It comes in the form of a lyophilized powder (white or slightly coloured) to be reconstituted with the solvent provided in its carton prior to being administered by intravenous injection.
Do not use Beriplex® P/N 500/ Beriplex® P/N 1000 if:
Beriplex® P/N should not be used if you are experiencing any of the following:
- Hypersensitivity to the active substance or to any of the excipients listed in section 6 Dosage Forms, Strengths, Composition, and Packaging.
- Disseminated intravascular coagulation.
- Known history of heparin-induced thrombocytopenia.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Beriplex® P/N 500/ Beriplex® P/N 1000. Talk about any health conditions or problems you may have, including if you:
- are on a controlled sodium diet.
- have a history of coronary heart disease, myocardial infarction, liver disease, are at risk for thromboembolic phenomena or disseminated intravascular coagulation, or have simultaneous inhibitor deficiency.
are breastfeeding, pregnant or trying to become pregnant.
- have recently undergone surgery.
- are allergic to Beriplex® P/N, its ingredients or the components of its container.
- are receiving vitamin K antagonists.
- have a history of acquired or congenital deficiency of the vitamin K-dependent coagulation factors.
- have a history of heparin-induced thrombocytopenia.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Beriplex® P/N 500/ Beriplex® P/N 1000:
Beriplex® P/N neutralises the effects of vitamin K antagonist treatments.
When performing clotting tests which are sensitive to heparin in patients receiving high doses of human prothrombin complex, the heparin as a constituent of the administered product must be taken into account.
How to take Beriplex® P/N 500/ Beriplex® P/N 1000:
Beriplex® P/N should be reconstituted according to the instructions below. The reconstituted solution should be administered intravenously (not more than 3 IU/kg/min, max. 210 IU/min, approximately 8 ml/min).
Parenteral Products:
Bring the product and the solvent (diluent) to room temperature. Ensure that the product and solvent vial flip caps are removed and that the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial® package.
- 1. Open the Mix2Vial® package by peeling off the lid. Do not remove the Mix2Vial® from the blister package.
- 2. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial® together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
- 3. Carefully remove the blister package from the Mix2Vial® set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial® set.
- 4. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial® set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.
- 5. With the diluent and Beriplex vial still attached to the Mix2Vial® set, gently swirl the Beriplex vial to ensure the product is fully dissolved. Do not shake.
- 6. With one hand grasp the product side of the Mix2Vial® set, and with the other hand grasp the solvent side and unscrew counterclockwise the set carefully into two pieces. Discard the solvent vial with the blue Mix2Vial® adapter attached.
- 7. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial®´s Luer Lock fitting by screwing clockwise. Inject air into the product vial.
Withdrawal and application:
- 8. While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
- 9. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial® adapter from the syringe by unscrewing counterclockwise.
This medicinal product must not be mixed with other medicinal products except those mentioned in the section Reconstitution and Administration.
The solution should be clear or slightly opalescent. After filtering/withdrawal, the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy or have deposits.
Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.
In case more than one vial of Beriplex® is required, it is possible to pool several vials of Beriplex® for a single infusion via a commercially available infusion device.
The Beriplex® solution must not be diluted.
The reconstituted solution should be administered by a separate injection / infusion line by slow intravenous injection, at a rate not exceeding 3 IU/kg/minute, max. 210 IU/minute, approximately 8 ml/minute.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Because Beriplex® P/N contains no preservative; the reconstituted product should be used immediately to ensure its sterility. However, if it is not administered immediately, storage shall not exceed 3 hours at room temperature.
Usual dose:
Every patient is different; your health professional will determine what dose of Beriplex® P/N is right for you and how often you should receive it.
Overdose:
Overdosage with prothrombin complex concentrates has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. The risk of thromboembolic complications or disseminated intravascular coagulation due to overdosage is increased in patients at risk of these complications. Regular monitoring of the coagulation status will help avoid overdosage.
If you think you, or a person you are caring for, have taken too much Beriplex® P/N 500/ Beriplex® P/N 1000, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
Not applicable.
Possible side effects from using Beriplex® P/N 500/ Beriplex® P/N 1000:
These are not all the possible side effects you may have when taking Beriplex® P/N 500/ Beriplex® P/N 1000. If you experience any side effects not listed here, tell your healthcare professional.
The administration of Beriplex® P/N is usually well tolerated. Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. The efficacy of the prothrombin complex treatment may be affected by the presence of these inhibitors.
A doctor should be called immediately if any of these reactions occurs:
- Tissue and abdomen swelling from excess salt and fluid retention, frothy urine (nephrotic syndrome);
- Thromboembolic episodes (blood clots); which may include limb pain and/or swelling, chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, loss of sensation or motor power;
- Increase in body temperature;
- Hypersensitivity or allergic reactions: May include angioedema, burning / stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, angina pectoris, tingling, vomiting or wheezing);
- Small blood clots or excessive bleeding due to depleted clotting factors (disseminated intravascular coagulation);
- Anaphylactic reactions including anaphylactic shock
- Development of antibodies to one or several factors of the prothrombin complex;
- Multiple purple pinpoint bruises, easy bruising, unusually heavy menstruation (could be caused by heparin-induced thrombocytopenia, type II).
Your doctor will decide whether it is appropriate or not to discontinue the treatment with Beriplex® P/N.
This is not a complete list of side effects. For any unexpected effects while taking Beriplex® P/N, contact your doctor or pharmacist.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
We recommend that CSL Behring Canada be copied when reporting suspected side effects, at the following address:
AdverseReporting@cslbehring.com
Storage:
Beriplex® P/N 500 and Beriplex® P/N 1000 can be stored either in the refrigerator or at room temperature (at +2°C to +25°C) for the period indicated by the expiration date printed on the carton and vial label. The shelf life of Beriplex® P/N is 36 months. Avoid freezing, which may damage the solvent container. Keep Beriplex® P/N in its box during storage.
Keep out of reach and sight of children.
If you want more information about Beriplex® P/N 500/ Beriplex® P/N 1000:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.cslbehring.ca); or by calling 1-866-773-7721
Date of Authorization: November 7, 2025