- human fibrinogen
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.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL17469/0006.
FibCLOT 1.5 g. Powder and solvent for solution for injection/infusion
FibCLOT 1.5 g
Powder and solvent for solution for injection/infusion
Package leaflet: Information for the user
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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 FibCLOT is and what it is used for
2. What you need to know before you use FibCLOT
3. How to use FibCLOT
4. Possible side effects
5. How to store FibCLOT
6. Contents of the pack and other information
1. WHAT FIBCLOT IS AND WHAT IT IS USED FOR
What FibCLOT is
It is a medicine which belongs to the class of antihaemorrhagics. The active substance is human fibrinogen, a protein which is naturally present in the body. The role of this protein is to ensure normal coagulation of the blood and to prevent that bleeding lasts too long.
What FibCLOT is used for
It is used in all age groups to compensate for the lack of human fibrinogen and, thus, prevent and treat bleeding (haemorrhages) in patients with congenital fibrinogen deficiency.
Congenital fibrinogen deficiency is a hereditary disease characterised by a level less than the normal value or an absence of a protein called fibrinogen. This lack may lead to prolonged bleedings.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FIBCLOT
Do not use FibCLOT
If you are allergic to the active substance (human fibrinogen) or any of the other ingredients of this medicine (listed in section 6. “Contents of the pack and other information").
Please inform your doctor if your are allergic to any medicine.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using FibCLOT.
Risk of blood clots
With high dose or repeating dosing, this medicine may increase the risk of blood clots in blood vessels.
As a consequence, your doctor should evaluate the benefits of this medicine against the risk of blood clots, particularly:
Your doctor may also ask you to perform additional tests in order to monitor this risk.
Risk of allergies
Your doctor will inform you of the warning signs of an allergic reaction (see section 4. “Possible side effects"). If one of these effects does occur, this medicine should be stopped immediately.
This medicine is manufactured from human plasma (the liquid part of blood).
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 or AIDS virus), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease 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 you receive a dose of this medicine, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Children and adolescents
Same warnings and precaution apply to children and adolescents.
Other medicines and FibCLOT
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
No interactions between this treatment and other medicines have been observed to date. However, it should not be mixed with any other products and/or medicinal products.
Pregnancy and breast-feeding
Driving and using machines
This medicine has no influence on the ability to drive and use machines.
FibCLOT contains up to 3 mmol (or 69 mg) of sodium per vial.
This should be taken into consideration if you are on a low salt diet.
3. HOW TO USE FIBCLOT
Treatment should be initiated under the supervision of a physician experienced in the treatment of congenital fibrinogen deficiency.
The appropriate dose and frequency will be determined by your doctor and will depend on the following:
Your doctor will recommend that you undergo blood tests during treatment to control your fibrinogen level.
Based on the results of these tests, your doctor may decide to adapt the dose and frequency of your injections.
Frequency of administration
Your doctor will determine how often injections must be administered.
Your doctor will adapt the number of injections based on the severity of your bleeding and the efficacy of the treatment.
Information on frequency and duration of treatment for various situations is shown at the end of this leaflet in the section reserved for health professionals.
Method of administration:
This medicine should be injected into the veins. If you have further questions on use of this product, ask your doctor, pharmacist or nurse.
If you use more FibCLOT than you should
To avoid risk of overdose, your doctor will perform regular blood tests to control your fibrinogen level.
In case of overdose, a risk of abnormal formation of clots in the blood cannot be excluded.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Risk of allergic reactions: as with any intravenous protein product, allergic reactions may occur. In some cases, these reactions have progressed to a serious allergic reaction.
The warning signs of allergic reactions are:
Blood clots: formation of blood clots may occur in the blood circulation. It may result in:
If one of these effects occurs, contact immediately a doctor who will, depending on the type and severity of the reaction, stop the treatment with this medicine and/or start an appropriate treatment.
The following side effects are common (may affect up to 1 in 10 infusions):
The following side effects are uncommon (may affect up to 1 in 100 infusions):
Children and adolescents
Frequency, type and severity of side effects are similar in adult and paediatric patients (from birth to less than 18 years of age) except for allergic/anaphylactic type reactions that occurred commonly in paediatric population.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FIBCLOT
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What FibCLOT contains
The active substance is human fibrinogen (1.5 g per vial). After reconstitution with 100 mL of water for injections FibCLOT contains 15 mg/mL of human fibrinogen.
The other ingredients are arginine hydrochloride, isoleucine, lysine hydrochloride, glycine, sodium citrate dihydrate and the solvent (water for injections).
What FibCLOT looks like and contents of the pack
This medicine is presented as a powder accompanied by solvent for solution for injections in glass vials and a transfer system.
The reconstituted solution should be almost colourless, slightly opalescent (having a pearl-like shine).
Marketing Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Germany, Greece, Spain and United Kingdom: FibCLOT
Denmark. Finland, Hungary, Luxembourg, Norway, Sweden, The Netherlands: Fibclot
Belgium: Fibclot 1,5 g, poudre et solvant pour solution injectable/pour perfusion
Czech republic, Slovakia: Fibclot 1,5 g
This leaflet was last revised in 11/2018
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