Feiba Vh

DRUG DESCRIPTION

FEIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated (AICC) is a freeze-dried sterile human plasma fraction with Factor VIII inhibitor bypassing activity. In vitro, FEIBA VH (AICC) shortens the activated partial thromboplastin time (APTT) of plasma containing Factor VIII inhibitor. Factor VIII inhibitor bypassing activity is expressed in arbitrary units. One IMMUNO Unit of activity is defined as that amount of FEIBA VH (AICC) that shortens the APTT of a high titer Factor VIII inhibitor reference plasma to 50% of the blank value. The product is intended for intravenous administration.

FEIBA VH (AICC) contains Factors II, IX, and X, mainly non-activated, and Factor VII13 mainly in the activated form. The product contains approximately equal unitages of Factor VIII inhibitor bypassing activity and Prothrombin Complex Factors. In addition, 1 6 units of Factor VIII coagulant antigen (FVIII C:Ag) per mL are present. The preparation contains only traces of factors of the kinin generating system. It contains no heparin.

Reconstituted FEIBA VH (AICC) contains 4 mg of trisodium citrate and 8 mg of sodium chloride per mL.

FEIBA VH (AICC), Vapor Heated has been prepared from Source Plasma and/or Plasma.

The product has been subjected to in-process virus inactivation where vapor is first applied for 10 hours at 60 ? 0.5C and an excess pressure of 190 ? 20 mbar followed by 1 hour at 80? 0.5C and an excess pressure of 370 ? 30 mbar. (See CLINICAL PHARMACOLOGY and WARNINGS sections).

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Feiba Vh

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Feiba Vh

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Feiba Vh

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Feiba Vh

What are the possible side effects of anti-inhibitor coagulant complex (Autoplex T, Feiba VH)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify...

Read All Potential Side Effects and See Pictures of Feiba Vh


Feiba Vh Patient Information Including Side Effects

Brand Names: Autoplex T, Feiba VH

Generic Name: anti-inhibitor coagulant complex (injectable) (Pronunciation: an TEE in HIH bih tor coe AG you lant COM plex)

  • What is anti-inhibitor coagulant complex (Feiba Vh)?
  • What are the possible side effects of anti-inhibitor coagulant complex (Feiba Vh)?
  • What is the most important information I should know about anti-inhibitor coagulant complex (Feiba Vh)?
  • What should I discuss with my healthcare provider before using anti-inhibitor coagulant complex (Feiba Vh)?
  • How should I use anti-inhibitor coagulant complex (Feiba Vh)?
  • What happens if I miss a dose (Feiba Vh)?
  • What happens if I overdose (Feiba Vh)?
  • What should I avoid while using anti-inhibitor coagulant complex (Feiba Vh)?
  • What other drugs will affect anti-inhibitor coagulant complex (Feiba Vh)?
  • Where can I get more information?

What is anti-inhibitor coagulant complex (Feiba Vh)?

Anti-inhibitor coagulant complex is made up of proteins normally present in the blood that allow the blood to clot.

Anti-inhibitor coagulant complex is used to treat or prevent bleeding in people with hemophilia and Factor VIII inhibitors.

Anti-inhibitor coagulant complex may also be used for purposes other than those listed here.

What are the possible side effects of anti-inhibitor coagulant complex (Feiba Vh)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from anti-inhibitor coagulant complex. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with anti-inhibitor coagulant complex.

If you experience any of the following serious side effects, contact your healthcare provider immediately or seek emergency medical attention:

  • an allergic reaction (shortness of breath; wheezing; tightness of the chest; closing of the throat; hives; swelling of the lips, face, or tongue; hives or rash; dizziness or fainting);
  • changes in pulse rate or blood pressure;
  • difficulty breathing, chest pain, or cough; or
  • pain, redness, or swelling at the injection site.

Other, less serious side effects may be more likely to occur. Continue to use anti-inhibitor coagulant complex and talk to your doctor if you experience

  • headache; or
  • flushing.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about anti-inhibitor coagulant complex (Feiba Vh)?

Anti-inhibitor coagulant complex is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although anti-inhibitor coagulant complex is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using anti-inhibitor coagulant complex.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from anti-inhibitor coagulant complex. Parovovirus B19 may more seriously affect pregnant women and those with poor immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark-colored urine and yellowing of the skin or whites of the eyes may also occur. Contact your doctor if you develop any of these symptoms after treatment with anti-inhibitor coagulant complex.

Carry or wear identification that will alert others that you have hemophilia or another blood clotting disorder in the case of an emergency.

Tell your doctor and dentist that you have hemophilia or another blood clotting disorder before having surgery or other invasive procedures.

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