CSL Behring
FIBROGAMMIN P 250 IU
Powder and solvent for injection or infusion
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your haemophilia nurse. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In This Leaflet:
1. What Fibrogammin P is and what it is used for
2. Before you use Fibrogammin P
3. How to use Fibrogammin P
4. Possible side effects
5. Storing Fibrogammin P
6. Further information
What Fibrogammin P Is And What It Is Used For
Fibrogammin P (Factor XIII) is a product made from human plasma (this is the liquid part of the blood). It is used to prevent or stop the bleeding that you might get because of a lack of factor XIII in your blood, a condition that you have had from birth. Factor XIII is needed for the formation of blood clots which help bleeding to stop and helps slow healing wounds to heal more quickly.
Before You Use Fibrogammin P
Do not use Fibrogammin P
- If you are allergic to any of the ingredients (see section 6). If you are unsure about this, ask your doctor.
Take special care with Fibrogammin P
- If you experience any signs of an allergic reaction to Fibrogammin P (for example a rash, tight chest, wheezing or feeling dizzy), stop injecting the product immediately and contact your doctor.
- You should visit your doctor or haemophilia treatment centre regularly to ensure that your dose is correct. The doctor may wish to carry out some tests to make sure that you are getting the right amount.
- If your bleeding is not being controlled with Fibrogammin P, tell your doctor immediately. You may have developed an inhibitor (an antibody which can cancel out the effects of factor XIII) and your doctor may wish to carry out more tests to confirm this.
- If you have ever had a blood clot (thrombosis), you should ask your doctor for advice.
Taking or using other medicines
There are no medicines that are known to react with Fibrogammin P. However, if you are taking another medicine and are concerned, please ask your doctor or haemophilia nurse.
Pregnancy and breast-feeding
If you are pregnant or planning a family soon, or if you are breast-feeding, ask your doctor for advice before using this product.
Driving and using machines
Fibrogammin P does not affect your ability to drive or use machines.
Important information about some of the ingredients of Fibrogammin P
Fibrogammin P contains up to 17 mg sodium per vial. Please take this into account if you are on a sodium (salt) controlled diet as you may need to cut down on the salt in your diet.
Fibrogammin P contains up to 24 mg glucose per vial. Please take this into account if you have diabetes.
Important safety information related to infections
When medicines are made from human blood, steps are taken to stop infections (e.g. HIV and Hepatitis) being passed on to the patient. This includes:
- Careful selection of the blood donors
- Testing of each donation for signs of infection
- Steps in the manufacture which can kill or remove viruses
However, there is still a small chance of an infection being passed on to the patient. This may include a new virus or infection. Therefore, every time Fibrogammin P is used, it is important to note the name and batch number of the medicine (found on the carton).
How To Use Fibrogammin P
The amount of factor XIII you need will depend on several factors, such as your weight, the severity of your condition, the site and severity of bleeding or the need to prevent bleeding during an operation or investigation.
Fibrogammin P is given by injection or infusion into a vein.
If you have been prescribed Fibrogammin P to use at home, your doctor or haemophilia centre nurse will make sure that you are shown how to inject it and how much to use.
If you are in any doubt about injecting Fibrogammin P, go back to your doctor or haemophilia centre for more advice and training before attempting to treat yourself.
Follow the directions given to you by your doctor or haemophilia nurse. You can also use the directions given below as a guide.
Directions for preparing and administering Fibrogammin P
- Wash your hands thoroughly using soap and warm water.
- Warm the Fibrogammin P powder vial and the liquid (Water for Injections) ampoule to room or body temperature without opening either container. You can do this by leaving them to stand at room temperature for about an hour after taking them out of the fridge or, if you need them quickly by holding them in your hands for a few minutes.
DO NOT expose the containers to direct heat or stand them on a radiator. They must not be heated above body temperature (37ยบ C). - Hold the water ampoule upright and shake it to move any liquid from the ampoule tip. Break off the ampoule tip with your thumb and index finger. Draw the water up into a sterile syringe with a sterile needle attached.
- Remove the cap from the powder vial and clean the rubber stopper with antiseptic solution. Allow to dry. Inject the water through the rubber stopper into the powder vial and swirl gently to dissolve. The solution should be clear or slightly cloudy, but should not contain particles.
- Once you have made up the solution, it should be used immediately. If this is not possible it should be used up within 8 hours. The solution should be put back in the fridge during this time.
- The solution should be injected at a maximum rate of 4 ml per minute.
- Any unused solution should be left in the vial or syringe. Dispose of all ampoules, vials, needles, syringes and antiseptic swabs in a ‘Sharps box’ or as you have been told. Do not throw them away with your household rubbish.
If you use more Fibrogammin P than you should
No symptoms of overdose with Fibrogammin P have been reported. However, if you accidentally inject a large overdose, then you should tell your doctor or haemophilia centre immediately.
If you forget to use Fibrogammin P
Inject your normal dose as soon as you remember and then continue as instructed by your doctor or haemophilia nurse.
Fibrogammin P Side Effects
Like all medicines, Fibrogammin P can cause side effects, although not everybody gets them.
Rare side effects (affect less than 1 in 1,000 people):
- Fever
- Rash, itchy swellings on the skin (hives)
- Low blood pressure which could make you feel faint or dizzy
- Difficulty breathing
Fibrogammin P could increase your risk of a thrombosis.
Symptoms of a thrombosis include:
- Unusual pain or swelling in your legs
- Sudden sharp pain in your chest
- Sudden difficulty breathing
- An unusual, severe or long-lasting headache
- Dizziness or fainting
If you have any of these symptoms, stop your injection immediately and contact your doctor.
If you notice that your Fibrogammin P is less effective than usual, contact your doctor or haemophilia centre immediately.
Storing Fibrogammin P
Store in a fridge at 2 °C to 8 °C, in the original packaging. Do not freeze.
Keep out of the reach and sight of children.
Do not use Fibrogammin P after the expiry date on the carton.
Further Information
What Fibrogammin P contains
The active substance is:
- 250 International Units (IU) human plasma coagulation factor XIII
Other ingredients are:
- human albumin
- glucose
- sodium chloride
- traces of sodium hydroxide or hydrochloric acid may also be present, (used for pH adjustment).
Bottles of product and liquid may appear partly empty but this is normal and does not mean that there is the wrong amount of powder or solution.
Marketing Authorisation Holder and Manufacturer
This leaflet was last approved on: 07/2010
For further information contact
No comments:
Post a Comment