Bebulin VH

Name: Bebulin VH

What is Bebulin VH (factor IX complex)?

Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with factor IX deficiency (hemophilia B). It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

Factor IX may also be used for purposes not listed in this medication guide.

How should I use Bebulin VH (factor IX complex)?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Factor IX complex is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Always check the strength of the medicine on the label to be sure you are using the correct potency.

Wash your hands before preparing and giving your injection.

Factor IX must be mixed with a liquid (diluent) before using it. Take the medicine and diluent out of the refrigerator and allow them to reach room temperature before mixing your dose. Do not heat the medicine or diluent. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve. Use the medicine as soon as possible after mixing.

You may store mixed medicine at room temperature but you must use it within 3 hours. Do not put mixed medicine into the refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or looks cloudy. Call your pharmacist for new medication.

A single dose of factor IX may be enough to control minor bleeding. If you need a second dose, wait at least 24 hours before using the medicine again.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

If you need any type of surgery or dental work, tell the surgeon or dentist ahead of time that you have hemophilia.

Your body may develop antibodies or "inhibitors" to factor IX complex. When the body develops antibodies or "inhibitors" to the clotting factor, this treatment becomes less effective in preventing bleeding episodes.

Call your doctor if this medicine seems to be less effective in controlling your bleeding.

While using factor IX complex, you may need frequent blood tests.

Store Bebulin and its diluent in a refrigerator. Do not freeze.

Store Profilnine and its diluent at room temperature, away from moisture and heat.

Throw away any unused medicine or diluent after the expiration date on the label has passed.

Bebulin VH (factor IX complex) side effects

Get emergency medical help if you have signs of an allergic reaction: hives or rash; fast heartbeats; chest tightness, wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • sweating and feeling short of breath;

  • a light-headed feeling, like you might pass out;

  • easy bruising, increased bleeding episodes;

  • bleeding from a wound or where the medicine was injected;

  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • headache;

  • flushing (warmth, redness, or tingly feeling);

  • nausea, vomiting;

  • fever, chills; or

  • lack of energy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Bebulin VH (factor IX complex)?

Tell your doctor about all other medicines you use, especially:

  • aminocaproic acid (Amicar); or

  • tranexamic acid (Cyklokapron, Lysteda).

This list is not complete. Other drugs may interact with factor IX complex, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Bebulin VH Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare
  • Changes in facial skin color
  • fast or irregular breathing
  • puffiness or swelling of the eyelids or around the eyes
  • shortness of breath, troubled breathing, tightness in chest, and/or wheezing
  • skin rash, hives, and/or itching

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bluish coloring (especially of the hands and feet)
  • convulsions
  • dizziness or lightheadedness when getting up from a lying or sitting position
  • increased heart rate
  • large blue or purplish patches in the skin (at places of injection)
  • nausea or vomiting
  • pains in chest, groin, or legs (especially calves)
  • persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine
  • severe pain or pressure in the chest and/or the neck, back, or left arm
  • severe, sudden headache
  • shortness of breath or fast breathing
  • sudden loss of coordination
  • sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Burning or stinging at place of injection
  • changes in blood pressure or pulse rate
  • chills
  • drowsiness
  • fever
  • headache
  • nausea or vomiting
  • redness of face
  • shortness of breath

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Principle Display Panel

Bebulin VH 200-1200 unit carton

20 mL size, dried

NDC 64193-244-02

Bebulin VH

(Factor IX Complex),

Vapor Heated

BAXTER (Logo)

WARNING: This product is prepared from large pools of human plasma. Human blood and its components may transmit infectious agents. The physician and patient should discuss the risks and benefits of this product.

Some components of the packaging material contain Dry Natural Rubber Latex.

The process has been subjected to in-process virus inactivation. For details, see package insert.

Rx Only

BEBULIN is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Bebulin VH 200-1200 vial label

20 mL size, dried

NDC 64193-244-03

Bebulin VH (Factor IX Complex), Vapor Heated

BAXTER (logo)

Contains no preservative. Reconstituted with 20 mL of Sterile Water of Injection, U.S.P. and keep at room temperature. Use within 3 hours after reconstitution. Administer by the intravenous route only. For complete information and dosage see accompanying directions for use. WARNING: This product is prepared from large pools of human plasma. Human blood and its components may transmit infectious agents. The physician and patient should discuss the risks and benefits of this product. Rx only. Store between 2º and 8ºC (35º and 46ºF).

BEBULIN is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Baxter Healthcare Corporation

Westlake Village, CA 91362 USA

U.S. License No. 140

U.S. Pat. Nos. 4,640,834

20 mL Sterile Water for Injection

NDC 0338-0764-62

20 mL

Single-Dose Container

Nonpyrogenic

Sterile Water for Injection, USP for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substances has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion. Rx Only. This Product Contains Dry Natural Rubber.

BAXTER

Manufactured by

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

BEBULIN  VH
coagulation factor ix human kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64193-244
Packaging
# Item Code Package Description
1 NDC:64193-244-02 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 20 mL
Part 2 1 VIAL, GLASS 20 mL
Part 1 of 2
BEBULIN  VH
coagulation factor ix human injection, powder, lyophilized, for solution
Product Information
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COAGULATION FACTOR IX HUMAN (COAGULATION FACTOR IX HUMAN) COAGULATION FACTOR IX HUMAN 300 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE  
SODIUM CHLORIDE  
HEPARIN  
Packaging
# Item Code Package Description
1 1 VIAL, GLASS (VIAL) in 1 CARTON
1 20 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103112 03/16/2011
Part 2 of 2
STERILE WATER 
water liquid
Product Information
Item Code (Source) NDC:0338-0764
Route of Administration INTRAVENOUS DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
WATER 20 mL  in 20 mL
Packaging
# Item Code Package Description
1 NDC:0338-0764-62 20 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103112 03/16/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103112 03/16/2011
Labeler - Baxter Healthcare Corporation (085206634)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 001728059 MANUFACTURE, LABEL
Revised: 03/2011   Baxter Healthcare Corporation
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