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COAGADEX- coagulation factor x human kit


  1. Patient Information
  2. Manufactured By:
  3. U.s. Distributor:
  4. What Is The Most Important Information I Need To Know About Coagadex?
  5. What Is Coagadex?
  6. Who Should Not Use Coagadex?
  7. You Should Tell Your Healthcare Provider If You:
  8. How Should I Use Coagadex?
  9. What Are The Possible Side-effects Of Coagadex?
  10. What Are The Coagadex Dosage Strengths?
  11. Coagadex Comes In Two Different Dosage Strengths:
  12. How Do I Store Coagadex?
  13. What Else Should I Know About Coagadex?

Patient Information 

  • Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Inform patients to immediately report the following early signs and symptoms of hypersensitivity reactions to their healthcare professional: angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing [seeWarnings and Precautions (5.1)].
  • Inform patients that the development of inhibitors to Factor X is a possible complication of treatment with COAGADEX. Advise the patients to contact their healthcare provider for further treatment and/or assessment if they experience a lack of clinical response to COAGADEX because this may be a manifestation of an inhibitor [seeWarnings and Precautions (5.2)].
  • Inform patients that COAGADEX is made from human plasma and may contain infectious agents that can cause diseases. While the risk that COAGADEX can transmit an infection has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing, patients should report any symptoms that concern them [seeWarnings and Precautions (5.3)].

Manufactured By: 


Bio Products Laboratory Ltd.,
Elstree,
WD6 3BX,
United Kingdom.

U.s. Distributor: 


BPL USA, Inc.,
302 East Pettigrew Street,
Suite C-190,
Durham, NC 27701,
USA

US License No: 1811

COAGADEXis a registered trade mark of Bio Products Laboratory Limited. Mix2Vial is a trade mark of West Pharmaceutical services.

Version 3

What Is The Most Important Information I Need To Know About Coagadex? 

Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center.

You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing COAGADEX so that your treatment will work best for you.

What Is Coagadex? 

COAGADEX is a medicine given as an injection into the vein to replace the clotting factor that is missing in people with Factor X deficiency. Factor X deficiency is an inherited bleeding disorder that prevents blood from clotting normally.

COAGADEX is used to treat, control or reduce bleeding in patients with hereditary Factor X deficiency.

Your healthcare provider may give you COAGADEX when you have surgery.

Who Should Not Use Coagadex? 

You should not use COAGADEX if you are allergic (hypersensitive) to any of the ingredients in COAGADEX.

Tell your healthcare provider if you are pregnant or breast-feeding because COAGADEX may not be right for you.

You Should Tell Your Healthcare Provider If You: 

  • Have or have had any medical problems
  • Have any allergies
  • Take any prescription and non-prescription medicines, including over-the-counter medicines, supplements or herbal medicines
  • Are breast-feeding. It is not known if COAGADEX passes into your milk and if it can harm your baby
  • Are pregnant or planning to become pregnant. It is not known if COAGADEX may harm your unborn baby
  • Have been told you have inhibitors to Factor X

How Should I Use Coagadex? 

You get COAGADEX as an infusion into your vein.

You may infuse COAGADEX at a hemophilia treatment center, at your healthcare provider's office or in your home. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with coagulation factor deficiencies learn to infuse their treatment by themselves or with the help of a family member or caregiver.

Your healthcare provider will tell you how much COAGADEX to use based on your weight, the severity of your Factor X deficiency, and where you are bleeding from.

You may need blood tests done after using COAGADEX to be sure that the level of Factor X in your blood is high enough to clot your blood.

Call your healthcare provider right away if your bleeding does not stop after using COAGADEX.

What Are The Possible Side-effects Of Coagadex? 

You can have an allergic reaction to COAGADEX.

Stop treatment and call your healthcare provider right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives.

Common side effects of COAGADEX are infusion site redness, infusion site pain, tiredness, and back pain.

Your body can also make antibodies, called "inhibitors," against COAGADEX, which may stop COAGADEX from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

These are not all of the possible side effects of COAGADEX. Tell your healthcare provider about any side effects that bother you or do not go away.

What Are The Coagadex Dosage Strengths? 

COAGADEX is packaged with a suitable volume (2.5 mL or 5 mL) of Sterile Water for Injection, and one Mix2Vial transfer device.

Coagadex Comes In Two Different Dosage Strengths: 

Approximately 250 International Units (IU) to be reconstituted with 2.5 mL of sterile water.

Approximately 500 International Units (IU) - to be reconstituted with 5 mL of sterile water.

The actual strength will be printed on the vial label and on the box. Once dissolved, the concentrations in these two vials will be the same, 100 IU per mL.

Always check the actual dosage printed on the label to make sure you are using the vial size prescribed by your healthcare provider.

Always check the expiration date printed on the box. Do not use the product after the expiration date printed on the box.

How Do I Store Coagadex? 

  • Keep COAGADEX in its original package to protect it from light.
  • Store COAGADEX in a refrigerator (not below 36 F [2 C]) or at room temperature (not to exceed 86 F [30 C]). Do not freeze.

What Else Should I Know About Coagadex? 

Medicines are sometimes prescribed for purposes other than those listed here. Do not use COAGADEX for a condition for which it is not prescribed. Do not share COAGADEX with other people, even if they have the same symptoms or condition that you have.

For further information or if you have any questions about COAGADEX, please contact BPL Inc. at the address below or through medinfo@bplgroup.com



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