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Genric name: Prothrombin Complex Concentrate, Human-Lans
Dosage form: powder for solution for intravenous administration
Drug class: anticoagulant reversal drugs

What is Balfaxar?

The use of Balfaxar can reverse the effects of blood-thinning medications like Warfarin on adult patients who require urgent surgery to minimize the bleeding risk. Balfaxar restores blood coagulation by increasing the blood clotting factor levels that are low after taking warfarin.Balfaxar contains a four-factor prothrombin concentrate (PCC-4F) that is not activated. Balfaxar is a concentrate of four factors: factor II (prothrombin), factor VII, factor IX, and factor X. It also contains antithrombotic proteins C and S.Balfaxar's generic name is human-lans prothrombin complex concentrate.Warfarin or other vitamin K inhibitors may be prescribed for patients with a heart attack, a heart valve surgery stroke, deep vein thrombosis or pulmonary embolism, and certain irregular heartbeats (atrial fibrillation). If they have to undergo an urgent procedure or require invasive surgery, patients on vitamin K or warfarin are at a higher risk of bleeding. Balfaxar is capable of restoring coagulation quickly, reducing the risk of bleeding.


In clinical trials as well as in post-marketing monitoring, this drug has been associated with both fatal and non-fatal arterial thromboembolic and venous complications. The signs and symptoms associated with thromboembolic events should be closely monitored in patients receiving this medication.If the risks of bleeding and thromboembolic complications are greater than the acute risk, then it is important to consider restarting the anticoagulation medication.Patients who have experienced thromboembolic events in the last 3 months may be ineligible for this medicine.The medicine contains human plasma, which may contain infectious agents such as viruses, variant Creutzfeldt Jakob Disease (vCJD), and, theoretically, Creutzfeldt jakob (CJD).

Before you take this drug

This medicine should only be taken by healthy individuals.

  • Allergy to human-lans or prothrombin complex concentrate, either alone or in combination with any other component of the product.
  • Have a history or known allergy to heparin, or have an existing heparin-induced thrombocytopenia.
  • Patients with antibodies to iga who are iga-deficient

Pregnancy This medicine is unknown to cause harm to an unborn child. Inform your doctor of any pregnancy or plans to become pregnant.Breastfeeding This medicine may pass into the breast milk. It is unknown if it will affect milk production or a nursing infant.

How to take Balfaxar?

Balfaxar intravenous is administered by your doctor before surgery or any procedure.The dosage of balfaxar is determined by the body weight.Reconstituted balfaxar should only be used immediately before use.Sterile water for injection is used as a diluent to reconstitute the powder.Vitamin K should be administered to Balfaxar-treated patients. Vitamin K can be administered after Balfaxar to maintain vitamin K-dependent clotting factors.

Details on dosage

The dose of Balfaxar is determined by body weight and INR before treatment.Normal Albfaxar adult dose for reversal of acquired coagulation factor deficiencyIf you are between INR2 and 4, you will receive 25 units/kg of body weight of factor IX intravenously. INR4 to 6: Receive 35 units/kg of body weight of factor IX intravenously.
If INR is greater than 6, 50 units of Factor IX per kg of body weight should be administered intravenously.

Maximum dose:
If INR is less than 4, 2500 Factor IX units are available.
Factor IX in the range of INR4 to 6:
If INR is greater than 6, 5000 factor IX units are required.

Duration of therapy:

Single dose. Clinical data does not support the use of repeat doses, and it is not recommended.


The dose is determined by the body weight, up to 100 kg. The maximum dose is not to be exceeded for patients who weigh more than 100kg. On the vial is written the dose according to actual potency, which can vary between 20 and 32 factor IX units/mL. A 1000-unit vial has a potency of 800–1280.

What happens if I miss the dose?

This medicine is given in a single dose because it's used only when necessary.

What happens if I overdose?

Overdoses are unlikely because this medication is administered by healthcare professionals in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions on foods, drinks, or activities, follow their instructions.

Side effects of Balfaxar

If you experience any of the following symptoms of an allergy to Balfaxar, seek immediate medical attention: hives; rash; diarrhea; nausea; feeling dizzy; rapid heartbeats; chest tightness; wheezing; difficulty breathing; swelling on your face, lips, or tongue.

Side effects of Balfaxar include:

  • Low red blood cells (anemia), pale skin and unusual fatigue, lightheadedness or feeling short of breath; cold hands, feet, and fingers
  • Stomach pain
  • Weakness or lack of energy
  • Infusion site reaction
  • Complications of wound healing and stitches
  • Pain during the procedure
  • Vomiting during the procedure
  • Painful Urination

Interaction with other drug

The prothrombin complex may also interact with other drugs, such as vitamins and herbs. Inform your doctor of all the medicines you are taking and those that you stop or start using.