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Active substance(s): HUMAN FIBRINOGEN

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If necessary, increase the temperature
of the two vials (powder and solvent) to
ambient temperature.


Remove the protective cap from the
solvent vial and from the powder vial.
Disinfect the surface of each stopper.


Remove the translucent protective
sheath from the transfer system and
completely insert the exposed piercing
spike through the centre of the stopper
of the solvent vial while simultaneously
twisting the piercing spike.


The reconstituted product should be examined visually prior
to administration in order to ensure that it does not contain
particulate matter. The reconstituted solution should be almost
colourless, slightly opalescent. Do not use solutions which are
cloudy or contain deposits.
FibCLOT should only be administered intravenously, as a single
dose, immediately after reconstitution, at no more than 4 mL/min.
If the reconstituted solution is not administered immediately,
storage shall not exceed 24 hours at room temperature (maximum
It is recommended to use an infusion set with a non-sterilising
15 µm filter.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
This medicinal product must not be mixed with other medicinal
products and should be administered by a separate injection/
infusion line.

Remove the second grey protective
sheath from the other end of the
transfer system.
Turn the solvent vial and quickly push
the free end of the piercing spike into
the center of the stopper of the powder
vial to allow the solvent to transfer into
the powder.
Ensure that the spike always remains
immersed in the solvent to avoid
releasing the vacuum prematurely.


During transfer, direct the jet of solvent
over the entire surface of the powder
and along the wall of the vial by a
rotational horizontal movement. Ensure
that all of the solvent is transferred.
The vacuum is automatically released
at the end of the transfer procedure by
sterile air through the venting part of
the transfer system.


Powder and solvent for solution
for injection/infusion
Human Fibrinogen

Package leaflet:
for the user

his medicine is subject to additional monitoring. This will
▼  Tallow
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.
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist
or nurse.
• 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

1. W
 hat 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 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


Remove the empty vial (solvent) with
the transfer system.
Gently swirl for a few minutes with
a rotating movement to avoid the
formation of foam until the powder has
completely dissolved.

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

Page 1 of 2

29/09/2016 15:36

FibCLOT 1.5 g/100 mL


LWA04Y_FibCLOT Notice UK.indd 1

FibCLOT 1.5 g

What is in this leaflet
1. W
 hat FibCLOT is and what it is used for
2. W
 hat you need to know before you use FibCLOT
 ow to use FibCLOT
3. H
4. Possible side effects
5. H
 ow to store FibCLOT
6. Contents of the pack and other information



Treatment should be initiated under the supervision of a
physician experienced in the treatment of coagulation disorders.
The dosage and duration of the substitution therapy depend on
the severity of the disorder, location and extent of bleeding and the
patient’s clinical condition.
The (functional) fibrinogen level should be determined in order
to calculate individual dosage and the amount and frequency of
administration should be determined on an individual patient basis
by regular measurement of plasma fibrinogen level and continuous
monitoring of the clinical condition of the patient and other
replacement therapies used.
Normal plasma fibrinogen level is in the range of 1.5 - 4.5 g/L. In
congenital hypo- or afibrinogenaemia, the critical plasma fibrinogen
level below which haemorrhages may occur is approximately 0.5 1.0 g/L.
In case of major surgical intervention, precise monitoring of
replacement therapy by coagulation assays is essential.
Treatment of bleeding and perioperative prophylaxis in patients
with congenital hypo- or afibrinogenaemia and known bleeding
To treat nonsurgical bleeding episodes, it is recommended to raise
fibrinogen levels to 1 g/L and maintain fibrinogen at this level until
haemostasis is controlled and above 0.5 g/L until healing is complete.
To prevent excessive bleeding during surgical procedures,
prophylactic treatment is recommended to raise fibrinogen levels
to 1 g/L and maintain fibrinogen at this level until haemostasis is
controlled and above 0.5 g/L until wound healing is complete.
In case of surgical procedure or treatment of a nonsurgical bleeding,
the dose should be calculated as follows:
Dose (g) = (target level (g/L) – baseline level (g/L)) x 0.043 x body
weight (kg),
where 0.043 corresponds to 1/recovery ((g/L)/(g/kg)).
In case of an emergency situation when the baseline fibrinogen level
is not known, the recommended initial dose is 0.05 g per kg of body
weight administered intravenously.
Subsequent posology (doses and frequency of injections) should
be adapted based on the patient’s clinical status and laboratory
Biological half-life of fibrinogen is 3 - 4 days. Thus, in the absence
of consumption, repeated treatment with human fibrinogen is not
usually required. Given the accumulation that occurs in case of
repeated administration for a prophylactic use, the dose and the
frequency should be determined according to the therapeutic goals
of the physician for a given patient.


The following information is intended for healthcare
professionals only:

Paediatric population
No recommendation on a posology can be made in children.
Use current guidelines for aseptic procedure.

AR/16C050/2.0 - September 2016
Mock up Package leaflet

This leaflet was last revised in 03/2016

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 weight,
• the severity of your disorder,
• the location and extent of bleeding, or the nature of your
• your overall health,
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
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
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.

By reporting side effects you can help provide more information
on the safety of this medicine.

4. Possible side effects

5. How to store FibCLOT

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:
• swelling of the face or throat,
• feeling of burning and tingling at the injection site,
• chills,
• redness, itching and rash,
• fast heart rate, low blood pressure,
• extreme tiredness (lethargy),
• feeling sick (nausea), vomiting,
• restlessness,
• tightness of the chest,
• pins and needles,
• wheezing (asthma-like).

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated
on the label and carton. The expiry date refers to the last day
of that month.
• Do not store above 25°C. Do not freeze.
• Keep the vial in the outer carton in order to protect from light
and moisture.
• Stability has been demonstrated for 24 hours at 25°C. However,
the product should be used immediately after reconstitution.
• Do not use this medicine if the reconstituted solution is cloudy
or if it has deposits.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the

Blood clots: formation of blood clots may occur in the blood
circulation. It may result in:
heart attack, the warning signs are sudden chest pain or
shortness of breath.
• stroke, the warning signs are sudden onset of muscle weakness,
loss of sensation and/or balance, decreased alertness or
difficulty in speaking.
• a serious condition called pulmonary embolism, the warning
signs are chest pain, difficulty in breathing or coughing up
clot in a vein (venous thrombosis), the warning signs are
redness, feel warmth, pain, tenderness, or have a swelling of
one or both legs.

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).

If one of these effects occurs, alert a doctor who will,
depending on the type and severity of the reaction,
immediately stop the treatment with this medicine and/or
start an appropriate treatment.

Marketing Authorisation Holder:
Laboratoire Français du Fractionnement et des Biotechnologies
3 Avenue des Tropiques, ZA de Courtaboeuf
91940 Les Ulis, FRANCE
Tel : +33(0) 1 69 82 70 10
Fax : +33(0) 1 69 82 19 03

The following adverse reactions are common (less than 1 in 10
• headache.
The following adverse reactions are uncommon (less than 1 in
100 infusions):
• dizziness,
• ringing of the ears,
• breathing difficulties (asthma),
• skin irritation, night sweat,
• feeling hot.
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 via the Yellow Card
Scheme at:

6. Contents of the pack and other information

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).

59 rue de Trévise, 59000 Lille, FRANCE
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
Italy: Fibriclotte

29/09/2016 15:36

FibCLOT 1.5 g/100 mL

Page 2 of 2

LWA04Y_FibCLOT Notice UK.indd 2

3. How to use FibCLOT

In case of overdose, a risk of abnormal formation of clots in the
blood cannot be excluded.



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:
• If you have had a heart attack (history of coronary heart disease
or myocardial infarction),
• If you have a liver disease,
• If you have just had surgery (patients postoperatively),
• If you will be having surgery soon (patients preoperatively),
• In newborn infants (neonates),
• If you are more likely to have blood clots than normal.
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.
Virus safety
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:
• 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 the 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 or AIDS
virus), hepatitis B virus and hepatitis C virus, and for the nonenveloped hepatitis A virus.
The measures taken may be of limited value against nonenveloped 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
• If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor for
advice before taking this medicine. This product should only
be used during pregnancy and breast-feeding on the advice of
your doctor.
• If you discover that you are pregnant during treatment, consult
with your doctor as only he/she can determine whether you
need to continue the treatment.
Driving and using machines
This medicine has no influence on the ability to drive and use
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.

AR/16C050/2.0 - September 2016
Mock up Package leaflet

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.

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