Consumer Information for: BERIPLEX P/N 1000

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Beriplex® P/N 500 / Beriplex® P/N 1000, commonly known as Beriplex® P/N (Human Prothrombin Complex), is indicated 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.
What it does

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.

When it should not be used

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 Dosage Forms, Composition and Packaging.
  • Disseminated intravascular coagulation.
  • Known history of heparin-induced thrombocytopenia.
What the medicinal ingredient is

Beriplex® P/N is a lyophilised plasma protein preparation containing human plasma coagulation factors II, VII, IX and X, as well as protein C and protein S.

What the non-medicinal ingredients are

Human antithrombin III, heparin, human albumin, sodium chloride, sodium citrate, HCl or NaOH (in small amount for pH adjustment).

For a full listing of non-medicinal ingredients see Part 1 of the product monograph.

What dosage form it comes in

Beriplex® P/N is available in single use vials of either 500 IU or 1000 IU. It comes in the form of a lyophilised powder (white or slightly coloured) to be reconstituted with the solvent provided in its carton prior to being administered by intravenous injection.

Warnings and precautions

Serious Warnings and Precautions

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.

BEFORE you use Beriplex® P/N talk to your doctor or pharmacist if:

  • You are on a controlled sodium diet.
  • You 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.
  • You 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.
  • You are receiving vitamin K antagonists.
  • You have a history of acquired or congenital deficiency of the vitamin K-dependent coagulation factors.
  • You have a history of heparin-induced thrombocytopenia.
Interactions with this medication

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.

Proper use of this medication

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.

Reconstitution:

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 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.
  6. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.
  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.

    8. 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. 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.

Side effects and what to do about them

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.

How to store

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.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect*
  • Call toll-free at 1-866-234-2345;
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Address Locator 1908C
      Ottawa, Ontario
      K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. 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: or be informed by pager Pager Number: 1-613-783-1892

More information

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.cslbehring.ca

or by contacting the sponsor, CSL Behring Canada, Inc. at: 1-613-783-1892.
This leaflet was prepared by CSL Behring Canada, Inc. Date of Approval:

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