CSL Behring
HAEMATE P 500 and 1000 IU
Powder and solvent for solution 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. If any of the side effects become serious or you notice any others not listed below, please tell your doctor or haemophilia nurse.
In This Leaflet:
1. What Haemate P is and what it is used for
2. Before you use Haemate P
3. How to use Haemate P
4. Possible side effects
5. Storing Haemate P
6. Further information
What Haemate P Is And What It Is Used For
Haemate P is a product made from human plasma (this is the liquid part of the blood). It is used to prevent or stop the bleeding caused by a lack of factor VIII (haemophilia A) or von Willebrand factor (von Willebrand disease) in your blood. Both these factors are needed for the formation of blood clots which help bleeding to stop.
Before You Use Haemate P
Do not use Haemate P
- If you are allergic to any of the ingredients. If you are unsure about this, ask your doctor (see section 6).
Take special care with Haemate P
- If you experience any signs of an allergic reaction to Haemate 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 Haemate P, tell your doctor immediately. You may have developed an inhibitor (an antibody which can cancel out the effects of factor VIII) and your doctor may wish to carry out more tests to confirm this.
- If you have von Willebrand’s Disease, you may be at risk of developing blood clots (thrombosis), particularly if you have known risk factors.
- Hepatitis A and B vaccination should be a consideration for patients who receive regular / repeated treatment of human plasma-derived products.
Taking or using other medicines
There are no medicines that are known to react with Haemate 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
Haemate P does not affect your ability to drive or use machines.
Important information about some of the ingredients of Haemate P
Haemate P contains up to 70 mg sodium per 1000 IU. 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.
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 Haemate P is used, it is important to note the name and batch number of the medicine (found on the carton).
How To Use Haemate P
The amount of factor VIII or von Willebrand factor 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. Haemate P is given by injection or infusion into a vein. If you have been prescribed Haemate 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 Haemate 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 below as a guide.
Directions for preparing and administering Haemate P
Wash your hands thoroughly using soap and warm water.
If necessary, warm the Haemate P powder vial and the liquid (Water for Injections) vial to room or body temperature without opening either vial. You can do this by leaving the vials to stand at room temperature for about an hour or, if you need them quickly by holding them in your hands for a few minutes.
DO NOT expose the vials to direct heat or stand the vials on a radiator. The vials must not be heated above body temperature (37º C).
Carefully remove the protective caps from the vials and clean the exposed rubber stoppers with the alcohol swab provided. Allow the vials to dry before opening the Mix2Vial package, then follow the instructions given below.
1. Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package.
2. Place the water vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the blue adaptor end straight down through the water vial stopper.
3. Carefully remove the blister package from the Mix2Vial set by holding at the rim and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set as well.
4. With the Haemate P vial firmly on an even surface, turn the water vial with the Mix2Vial set attached upside down and push the spike of the transparent adaptor end straight down through the Haemate P vial stopper.
The water will automatically flow into the Haemate P vial.
5. With one hand, grasp the Haemate P-side of the Mix2Vial set and with the other hand, grasp the waterside and unscrew the set carefully into two pieces (to avoid excessive foam build-up when dissolving the powder). Discard the water vial with the blue Mix2Vial adaptor attached.
Do not worry if there are a few flakes or particles left in the water as this can happen sometimes. They will be removed by the filter when you draw the liquid into the syringe.
6. Gently swirl the Haemate P vial with the transparent adaptor attached until the powder is fully dissolved. Do not shake.
7. Draw air into an empty, sterile syringe. While the Haemate P vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting and inject air into the Haemate P vial.
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.
Withdrawal and application
8. Keep the syringe plunger pressed in, turn the system upside down and draw the required amount of liquid into the syringe by pulling the plunger back slowly.
9. Once the liquid has all been transferred into the syringe, hold onto the barrel of the syringe firmly while keeping the syringe plunger facing down and disconnect the transparent Mix2Vial adaptor set from the syringe.
If there are any particles in the liquid in the syringe, or it is cloudy, do not inject it as this could block your blood vessels.
10. Attach a suitable injection needle (or the slow injection kit) to the syringe and get rid of all trapped air by turning the needle upwards and tapping the syringe gently so that any air bubbles rise, then push the barrel of the syringe up gently until the liquid begins to come out of the end of the needle. Once the product has been transferred into a syringe, it should be used immediately.
11. Apply a tourniquet as you have been shown and find a suitable vein, clean the skin surface with an alcohol swab and insert the needle or slow injection kit into the vein. Make sure that no blood enters the syringe.
12. Remove the tourniquet and inject the solution slowly into the vein, keeping the needle in place all the time. The solution should be injected at a maximum rate of 4ml per minute.
13. If more than one vial of Haemate P is needed, leave the syringe attached to the slow injection kit. Prepare a new vial as directed in steps 1 - 9, fill a new syringe, remove the old syringe from the slow injection kit and repeat steps 10 13.
14. If no further vials are needed, remove the needle or slow injection kit plus syringe, hold a sterile swab over the injection site for about 2 minutes with the arm stretched out and supported, then apply a small plaster.
Any unused solution should be left in the vial or syringe. Dispose of all vials, needles, syringes and swabs in a ‘Sharps box’ or as you have been told. Do not throw them away with your household rubbish.
If you use more Haemate P than you should
No symptoms of overdose with Haemate P have been reported. However, if you accidentally inject a large overdose, then you should tell your doctor or haemophilia centre immediately.
In some circumstances, you may be a risk of a thrombosis (blood clot). Symptoms of a thrombosis are listed in the side effects section.
If you forget to use Haemate P
Inject your normal dose as soon as you remember and then continue as instructed by your doctor or haemophilia nurse.
Possible Side Effects
Like all medicines, Haemate P can cause side effects, although not everybody gets them.
Rare side effects (affect less than 1 in 1,000 people):
- Fever
Very rare side effects (affect less than 1 in 10,000 people):
- Chills, flushing, redness, swelling
- Burning and stinging around the injection/infusion site
- Itching, tingling, rash
- Headache, dizziness, feeling sick or actually being sick
- Tight chest, wheezing, faster heartbeat
- Feeling restless or feeling tired
If your side effects are severe, this could be a sign of allergic shock (anaphylaxis), so stop your injection immediately and contact your doctor.
If you inject too much Haemate P, you may be at risk of a thrombosis (blood clot) where you do not want one, especially if you have von Willebrand disease. You may also be at risk if you have a family history of thrombosis or if you have ever had 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 Haemate P is less effective than usual, contact your doctor or haemophilia centre immediately.
Storing Haemate P
Do not store above 25 ºC. Do not freeze.
Keep the vials in the outer carton, in order to protect from light.
Keep out of the reach and sight of children.
Do not use Haemate P after the expiry date on the carton. Please ask your doctor or haemophilia nurse how to dispose of the medicine properly.
Further Information
What Haemate P contains
The active substances are:
- 500 or 1000 International Units (IU) human plasma coagulation factor VIII and 1200 or 2400 IU von Willebrand factor.
Other ingredients are:
- glycine
- human albumin
- sodium citrate
- sodium chloride
- traces of sodium hydroxide or hydrochloric acid may also be present (used for pH adjustment).
Bottles of product and liquid will 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
This leaflet was last approved on: 07/2010
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