CSL Behring
Beriplex P/N 250 and 500 IU
Powder and solvent for solution for injection.
Human prothrombin complex
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, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Beriplex P/N is and what it is used for
- 2. Before you use Beriplex P/N
- 3. How to use Beriplex P/N
- 4. Possible side effects
- 5. How to store Beriplex P/N
- 6. Further information
What Beriplex P/N Is And What It Is Used For
What is Beriplex P/N?
Beriplex P/N is presented as powder and solvent. The made up solution is to be given by injection into a vein.
Beriplex P/N is made from human plasma (this is the liquid part of the blood) and it contains the human coagulation factors II, VII, IX and X. Concentrates including these coagulation factors are called prothrombin complex products. The coagulation factors II, VII, IX and X are vitamin K-dependent and are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. The replacement of factors II, VII, IX and X with Beriplex P/N will repair the coagulation mechanisms.
What is Beriplex P/N used for?
Beriplex P/N is used for the prevention (during surgery) and treatment of bleedings caused by the acquired or congenital lack of vitamin K-dependent coagulation factors II, VII, IX and X in the blood, when purified specific coagulation factor products are not available.
Before You Use Beriplex P/N
The following sections contain information that your doctor should consider before you are given Beriplex P/N.
Do NOT use Beriplex P/N:
- if you are hypersensitive (allergic) to any of the active substances or other ingredients of Beriplex P/N (see section 6. Further Information).
Please inform your doctor if you are allergic to any medicine or food.
- if you suffer from a severe dysfunction of the blood clotting (coagulation) process, e.g.
- increased risk of forming blood clots (thrombosis, disseminated intravascular coagulation), tightness in the chest (angina pectoris), recent heart attack (myocardial infarction)
- allergic response to heparin, causing a fall in the number of blood platelets (heparininduced thrombocytopenia Type II, HIT Type II).
Please inform your doctor or pharmacist if you suffer from such a disease.
Take special care with Beriplex P/N:
- in case of acquired deficiency of the vitamin K-dependent coagulation factors. This may be induced by treatment with medicines inhibiting the vitamin K effect. Beriplex P/N is only allowed to be used when rapid correction of the prothrombin complex levels is necessary, e.g. in case of major bleedings or emergency surgery
- if you suffer from congenital deficiency of any of the vitamin K-dependent factors. In this case you should use specific coagulation factor products when available
- in case of allergic or anaphylactic-type reactions (a serious allergic reaction that causes severe difficulty in breathing or dizziness). The application of Beriplex P/N should be stopped immediately (e.g. discontinue injection)
- if you take coagulation inhibitors
- because of an increased risk of formation of blood clots in a blood vessel (thrombosis), particularly:
- if you have had a heart attack (a history of coronary heart disease or myocardial infarction)
- if you suffer from liver disease
- if you have just had surgery (patients postoperatively)
- in new-born infants (neonates)
- if you are more likely to suffer from blood clots than normal (patients at risk of thromboembolic phenomena or disseminated intravascular coagulation or simultaneous inhibitor deficiency)
- if you are suffering from an increased coagulation risk due to increased consumption of blood platelets or blood coagulation factors. Treatment with Beriplex P/N can only be started after treatment of the underlying cause.
Your doctor will consider carefully the benefit of treatment with Beriplex P/N compared with the risk of these complications.
Virus safety
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
- careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
- the testing of each donation and pools of plasma for signs of virus/infections.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (inflammation of the liver).
The measures taken may be of limited value against non-enveloped viruses such as hepatitis A (inflammation of the liver) and parvovirus B19.
Parvovirus B19 infection may be serious:
- for pregnant women (infection of the unborn child) and
- for individuals with a depressed immune system or with an increased production of red blood cells due to certain types of anaemia (e.g. sickle cell anaemia or haemolytic anaemia).
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived products.
It is strongly recommended that every time that Beriplex P/N is given, your doctor should record the date of administration, the batch number and the injected volume.
Taking other medicines
- Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including medicines obtained without a prescription.
- Beriplex P/N may inhibit the effect of vitamin K antagonist treatment. No interactions with other medicinal products are known.
- Beriplex P/N must not be mixed with other medicinal products, diluents or solvents.
Pregnancy and breast-feeding
- If you are pregnant or breast-feeding, please ask your doctor or pharmacist for advice before taking any medicine.
- During pregnancy and breast-feeding Beriplex P/N should be given only if it is clearly indicated.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Important information about some of the ingredients in Beriplex P/N
Beriplex P/N contains up to 343 mg sodium (approximately 15 mmol) per 100 ml. Please take this into account if you are on a controlled sodium diet.
How To Use Beriplex P/N
Treatment should be started and supervised by a physician who is experienced in this type of disorder.
Dosage
The amount of Factor II, VII, IX and X you need and the duration of treatment will depend on several factors, such as your body weight, the severity of your disease, the site and intensity of the bleeding or the need to prevent bleeding during an operation or investigation (see section “The following information is intended for medical or healthcare professionals only”).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Overdose
Your doctor should regularly check your blood clot status during the treatment. High doses of prothrombin complex concentrate have been associated with instances of heart attack, disseminated intravascular coagulation and an increased formation of blood clots in a blood vessel in patients at risk of these complications.
Beriplex P/N Side Effects
Like all medicines, Beriplex P/N can cause side effects, although not everybody gets them.
Please contact your doctor immediately
if any of the side effects occur, or
if you notice any side effects not listed in this leaflet.
The following side effects have been observed very rarely (less than 1 of 10,000 patients):
- A sudden allergic reaction (such as skin rash, burning and stinging where the injection was given, chills, flushing, skin rash over the whole body, headache, hives, fall in blood pressure, tiredness, nausea, vomiting, restlessness, tingling, faster heart beat and tightness of the chest, wheezing)
Development of antibodies to one or several coagulation factors
Increase in body temperature
- There is a risk of increased formation of blood clots (see section 2 “Take special care with Beriplex P/N”).
Reduced development of blood platelets due to heparin (heparin-induced thrombocytopenia, HIT Type II). Heparin, a protein with a blood clot dissolving effect, is an ingredient of Beriplex P/N. The severe form of a decrease in blood platelets may be associated with:- blood clots in the vein or leg
- an increased formation of blood clots
- in some cases with skin rash where the injection was given
- pinpoint-sized haemorrhages
- tarry stool.
In these cases the effect of heparin may be diminished (heparin tolerance). If these symptoms occur, you should stop using the product immediately and contact your doctor. In the future no heparin-containing products should be used.
The following side effect occurred in a single case:
- A special form of inflammation of the kidneys has been reported after treatment of patients who suffer from Factor IX inhibitors. These patients were also known to have a history of allergic reaction.
How To Store Beriplex P/N
Do not use Beriplex P/N after the expiry date, which is stated on the label and carton.
- Do not store above 25°C.
- Do not freeze.
- Keep the vial in the outer carton, in order to protect from light.
- Beriplex P/N does not contain a preservative so the made-up solution should preferably be used immediately.
- If the made-up solution is not administered immediately it must be used within 8 hours.
Keep out of the reach and sight of children.
Further Information
What Beriplex P/N 250 IU contains
Beriplex P/N 250 IU is presented as a powder and solvent. The powder should be dissolved with 10 ml of water for injection.
Beriplex P/N 250 IU contains 200 – 310 IU human coagulation factor IX per vial.
What Beriplex P/N 500 IU contains
Beriplex P/N 500 IU is presented as a powder and solvent. The powder should be dissolved with 20 ml of water for injection.
Beriplex P/N 500 IU contains 400 – 620 IU human coagulation factor IX per vial.
The active substance is:
A concentrate of the human coagulation factors II, VII, IX and X, Proteins C and S.
The other ingredients are:
Human antithrombin III, heparin, human albumin, sodium chloride, sodium citrate, HCl or NaOH (in small amounts for pH adjustment)
Solvent: Water for injections
What Beriplex P/N looks like and contents of the pack
Beriplex P/N is presented as a white powder and is supplied with water for injections as solvent. The made-up solution should be clear or slightly opalescent, i.e. it might sparkle when held up to the light but must not contain any obvious particles.
Presentation
One pack with 250 IU containing:
- 1 vacuum vial with dried substance
- 1 vial with 10 ml water for injections
- 1 filter transfer device 20/20
One pack with 500 IU containing:
- 1 vacuum vial with dried substance
- 1 vial with 20 ml water for injections
- 1 filter transfer device 20/20
Marketing Authorisation Holder and Manufacturer
This leaflet was last approved in December 2009.
For further information, please contact
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