Beriplex P/N 500 IU

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

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.

Do NOT use Beriplex:

• if you are allergic to any of the active substances or other ingredients of this medicine (listed in section 6).

Please inform your doctor if you are allergic to any medicine or food.

• if you are more likely to suffer from blood clots than normal (patients at risk of disseminated intravascular coagulation)
• if you show an allergic response to heparin, causing a fall in the number of blood platelets (heparin-induced thrombocytopenia Type II, HIT Type II).

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:

• Acquired deficiency of the vitamin K-dependent coagulation factors:
  This may be induced by treatment with medicines inhibiting the vitamin K effect. Beriplex 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
• Congenital deficiency of any of the vitamin K-dependent factors:
  In this case you should use specific coagulation factor products when available
• Allergic or anaphylactic-type reactions (a serious allergic reaction that causes severe difficulty in breathing or dizziness):
  The application of Beriplex should be stopped immediately (e.g. discontinue injection)
• 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 per- or 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)
• Increased coagulation risk due to increased consumption of blood platelets or blood coagulation factors. Treatment with Beriplex can only be started after treatment of the underlying cause.
• 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. 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 and
  • 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.

• A special form of inflammation of the kidneys has been reported after treatment of patients who suffer from haemophilia B with factor IX inhibitors. These patients were also known to have a history of allergic reaction.

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:

• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
• the testing of each donation and pools of plasma for signs of virus/infections,
• the inclusion of 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), 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

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any medicines.
• Beriplex may inhibit the effect of vitamin K antagonist treatment. No interactions with other medicinal products are known.
• This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• During pregnancy and breast-feeding Beriplex should be given only if it is clearly indicated.
• No fertility data are available.

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.

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.

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.

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:

• 1 vial with powder
• 1 vial with 10 ml water for injections
• 1 filter transfer device 20/20

One pack with 500 IU containing:

• 1 vial with powder
• 1 vial with 20 ml water for injections
• 1 filter transfer device 20/20

One pack with 1000 IU containing:

• 1 vial with powder
• 1 vial with 40 ml water for injections
• 1 filter transfer device 20/20

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer