Active ingredient
- factor IX
- factor II
- factor VII
- factor X
- protein c
- protein s
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 15036 / 0029, PL15036/0028, PL15036/0034.
Beriplex P/N 250, 500 & 1000 IU
Package leaflet: Information for the user
Beriplex® P/N 250, 500 and 1000 IU
Powder and solvent for solution for injection
Human prothrombin complex
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Beriplex is and what it is used for
2. What you need to know before you use Beriplex
3. How to use Beriplex
4. Possible side effects
5. How to store Beriplex
6. Contents of the pack and other information
1. What Beriplex is and what it is used for
What is Beriplex?
Beriplex is presented as powder and solvent. It is a white or slightly coloured powder or friable solid. The made up solution is to be given by injection into a vein.
Beriplex 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 will repair the coagulation mechanisms.
What is Beriplex used for?
Beriplex 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.
2. What you need to know before you use Beriplex
The following sections contain information that your doctor should consider before you are given Beriplex.
Do NOT use Beriplex:
Please inform your doctor if you are allergic to any medicine or food.
Please inform your doctor or pharmacist if you suffer from such a disease.
Warnings and precautions
Talk to your doctor or pharmacist before using Beriplex in case of:
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.
Your doctor will consider carefully the benefit of treatment with Beriplex 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:
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), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived prothrombin complex products.
It is strongly recommended that every time you receive a dose of Beriplex, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Other medicines and Beriplex
Pregnancy, breast-feeding and fertility
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Beriplex contains sodium
Beriplex 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.
3. How to use Beriplex
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 and nature 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 healthcare professionals only”).
If you have any further questions on the use of this medicine, 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed commonly (may affect up to 1 in 10 people):
The following side effects occurred uncommonly (may affect up to 1 in 100 people):
The frequency of the following side effects is not known (cannot be estimated from the available data)
Paediatric population
No data are available regarding the use of Beriplex in the paediatric population.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
UK:
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland:
Malta:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Beriplex
6. Contents of the pack and other information
What Beriplex contains:
Beriplex 250 IU contains 200 – 310 IU human coagulation factor IX per vial.
Beriplex 500 IU contains 400 – 620 IU human coagulation factor IX per vial.
Beriplex 1000 IU contains 800 – 1240 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 looks like and contents of the pack
Beriplex is presented as a white or slightly coloured powder and is supplied with water for injections as solvent. The powder should be dissolved with 10 ml (250 IU), 20 ml (500 IU) or 40 ml (1000 IU) of water for injections.
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:
One pack with 500 IU containing:
One pack with 1000 IU containing:
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 10/2018.
4 Milton Road, Haywards Heath, West Sussex, RH16 1AH, UK
+44 (0)1444 447 400
+44 (0)1444 447 405
+44 (0)1444 447 402
+44 (0)1444 447 403
+44 (0)1444 447 405