FIBRICLOTTE 1.5G/100ML Порошок и раствор для инъекционного/инфузионного раствора

Содержание инструкции

1. Fibriclotte 1,5 g
   1. What is Fibriclotte and what is it used for
   2. What you need to know before using Fibriclotte
   3. How to use Fibriclotte
   4. Possible side effects
   5. How to store Fibriclotte
   6. Contents of the pack and other information

Fibriclotte 1,5 g

Powder and solvent for injectable solution/for infusion
human fibrinogen

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Fibriclotte is and what it is used for
• 2. What you need to know before you use Fibriclotte
• 3. How to use Fibriclotte
• 4. Possible side effects
• 5. How to store Fibriclotte
• 6. Contents of the pack and other information

1. What is Fibriclotte and what is it used for

What is Fibriclotte
It is a medicine that belongs to the class of antihemorrhagics. The active ingredient is fibrinogen
human, a protein naturally present in the body. This protein has the function of
ensuring normal blood coagulation and preventing bleeding from lasting too long.

What is Fibriclotte used for
It is used in all age groups to compensate for a deficiency of human fibrinogen and, therefore, prevent and
treat bleeding (hemorrhages) in patients affected by congenital fibrinogen deficiency.
Congenital fibrinogen deficiency is a hereditary disease characterized by a level lower than
normal or the absence of a protein called fibrinogen. This deficiency can cause prolonged bleeding.

2. What you need to know before using Fibriclotte

Do not use Fibriclotte
If you are allergic to the active ingredient (human fibrinogen) or to any of the other ingredients of this medicine (listed in section 6. "Contents of the pack and other information").

Tell your doctor if you are allergic to any medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fibriclotte.
Traceability
It is strongly recommended that each time you receive a dose of this medicine, the name and batch number are recorded to keep a record of the batch used.
Risk of blood clot formation
At high doses or with repeated administrations, this medicine may increase the risk of blood clot formation in blood vessels.
Consequently, the doctor must assess the benefits of the medicine against the risk of blood clot formation, in particular:

• If you have had a heart attack (history of coronary artery disease or myocardial infarction).
• If you suffer from a liver disease.
• If you have just undergone surgery.
• If you will undergo surgery shortly.
• In newborns (neonates).
• If you have a higher than normal probability of developing blood clots. The doctor may also ask you to undergo further tests to monitor this risk.

Risk of allergies
The doctor will inform you of the warning signs of an allergic reaction/serious allergic reaction (anaphylactic reaction) (see section 4. "Possible side effects"). If any of these effects occur, the medicine must be stopped immediately.
Safety against viruses
This medicine is made from human plasma (the liquid part of blood).
When medicines are made from blood or human plasma, certain measures are taken to prevent the transmission of infections to patients, including:

• careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded;
• testing of each donation and plasma pool for signs of viral infections;
• inclusion in the processing of blood or plasma of steps that can inactivate or remove viruses. Despite these measures, when administering medicines prepared from blood or plasma, it is not possible to completely exclude the possibility of infection transmission. This also applies to unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses, such as the human immunodeficiency virus (HIV or AIDS virus), the hepatitis B virus and the hepatitis C virus, and for the non-enveloped hepatitis A virus.
The measures taken may have limited effectiveness against non-enveloped viruses, such as parvovirus B19. Parvovirus B19 infection can be serious for pregnant women (fetal infection) and for individuals with a compromised immune system or who suffer from any form of anemia (e.g. sickle cell disease or hemolytic anemia).
The doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly use plasma-derived products.

Risk of antibody formation
In the case of replacement therapy with coagulation factors in other congenital diseases, antibody reactions have been observed, but currently no data are available regarding fibrinogen.

Children and adolescents
The warnings and precautions above also apply to children and adolescents.

Other medicines and Fibriclotte
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
To date, no interactions have been observed between this treatment and other medicines. However, it should not be mixed with other products and/or medicines.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. This product should be used during pregnancy and breastfeeding only after consultation with your doctor.
• If you discover you are pregnant during treatment, consult your doctor because they are the only ones who can determine whether you should continue therapy.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery.

Fibriclotte contains sodium
This medicine contains up to 3 mmol (or 69 mg) of sodium (the main component of table salt) per vial. This is equivalent to 3.45% of the recommended maximum daily intake of sodium with the diet of an adult.
This should be taken into account if you are following a low-salt diet.

3. How to use Fibriclotte

Treatment must be initiated under the supervision of a physician experienced in the treatment of congenital fibrinogen deficiency.

Dosage
The appropriate dose and frequency of administration will be determined by the physician and will depend on:

• body weight,
• severity of the disorder,
• location and extent of bleeding or nature of the surgical procedure,
• health conditions.

The physician will recommend that you undergo blood tests during treatment to monitor the fibrinogen level.
Based on the results of these tests, the physician may decide to adjust the dose and frequency of injections.

Frequency of administration
The frequency of administration of injections will be determined by the physician.
The physician will adjust the number of injections based on the severity of the bleeding and the effectiveness of the treatment.
information on the frequency and duration of treatment in various situations.

Method of administration:
This medicine must be injected into a vein. It is mandatory to use an infusion set equipped with a 15 µm filter, such as the one provided in the package. If you have any doubts about the use of this product, please contact your doctor, pharmacist or nurse.

If you use more Fibriclotte than you should
To avoid the risk of overdose, the physician will subject you to regular blood tests to check the fibrinogen level.
In case of overdose, the risk of abnormal clot formation in the blood cannot be excluded.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most serious side effects are:

• Allergic reactions:as with any protein-based product for intravenous use, allergic reactions may occur. In some cases, these reactions have evolved into a serious allergic reaction; sometimes with a sudden drop in blood pressure (anaphylactic shock). The warning signs of allergic reactions are:
• a burning and stinging sensation at the injection site,
• tingling,
• redness, itching and rash,
• wheals (urticaria),
• skin inflammation,
• pallor,
• swelling of the face or throat,
• cough,
• wheezing (similar to asthma).
• chest tightness,
• rapid heartbeat,
• low blood pressure,
• extreme fatigue (lethargy),
• restlessness,
• chills,
• feeling unwell (nausea), vomiting,

If you experience any of these effects, contact your doctor immediatelywho, depending on the type
and severity of the reaction, will discontinue treatment with this medicine and/orinitiate
appropriate treatment.

• Blood clots:blood clots may form in the bloodstream, which can cause:
• heart attack, whose warning signs are sudden chest pain or shortness of breath.
• stroke, whose warning signs are sudden onset of muscle weakness, loss of sensation and/or balance, decreased state of attention or difficulty speaking.
• a serious condition called pulmonary embolism (a blood clot that blocks an artery in the lungs), whose warning signs are chest pain, difficulty breathing or coughing up blood.
• a clot in a vein (venous thrombosis), whose warning signs are redness, warmth, pain, tenderness or swelling of one or both legs.

If you experience any of these effects, contact your doctor immediatelywho, depending on the type and
severity of the reaction, will discontinue treatment with this medicine and/orinitiate
appropriate treatment.
The following side effects are common(may affect up to 1 in 10 infusions):

• headache.

The following side effects are uncommon(may affect up to 1 in 100 infusions):

• allergic reaction (including anaphylactic shock, pallor, feeling unwell (vomiting), cough, low blood pressure, chills, wheals (urticaria), see also paragraph "Allergic reactions"),
• dizziness,
• vomiting (associated with headache),
• ringing in the ears,
• blood circulation disorder (deep vein thrombosis, superficial vein thrombosis),
• difficulty breathing (asthma),
• rash, skin redness, skin irritation, night sweats,
• feeling of warmth.

Children and adolescents
The frequency, type and severity of side effects in pediatric patients (from birth to
completion of 18 years) are similar to those of adults, except for allergic/anaphylactic reactions, which occur more commonly in the pediatric population.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Fibriclotte

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 on the packaging. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Do not freeze.
Store the vial in the outer packaging to protect the medicine from light and moisture.
The product must be used immediately after reconstitution. Do not store the reconstituted product.
Do not use this medicine if the reconstituted solution is cloudy or contains deposits.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fibriclotte contains
The active ingredient is human fibrinogen (1.5 g per vial). After reconstitution with 100 ml of
water for injections, Fibriclotte contains 15 mg/ml of human fibrinogen.
The other components are arginine hydrochloride, isoleucine, lysine hydrochloride, glycine, sodium citrate
dihydrate and solvent (water for injections).

Description of the appearance of Fibriclotte and contents of the pack
This medicine is supplied as a powder accompanied by a solvent for solution
for injection in glass vials, a transfer system and an infusion set equipped with a 15 μm filter..
The reconstituted solution should be almost colorless, slightly opalescent (with a pearly appearance).

Marketing Authorisation Holder:
Laboratoire français du Fractionnement et des Biotechnologies
Tour W – 102 Terrasse Boieldieu 19ème Étage 92800 Puteaux, FRANCE
Tel.: +33(0) 1 69 82 70 10
Fax: +33(0) 1 69 82 19 03

Manufacturer:
LFB BIOMEDICAMENTS
59 rue de Trévise, 59000 Lille, FRANCE

Distributor for sale:
BIOVIIIx srl
Via A. Manzoni, 1

• 80123 - Napoli ITALY

This medicine is authorised in the Member States of the European Economic Area with the
following denominations:
Austria, Germany, Greece, Spain and United Kingdom: FibCLOT
Denmark, Finland, Hungary, Luxembourg, Norway, Sweden, Netherlands: Fibclot
Belgium: Fibclot 1.5 g, powder and solvent for solution for injection/for infusion
Italy: Fibriclotte
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The following information is intended exclusively for healthcare professionals:
Treatment must be initiated under the supervision of a physician experienced in the treatment of
coagulation disorders.
Posology
The dosage and duration of replacement therapy depend on the severity of the disease, the site and
extent of the bleeding and the patient’s clinical condition.
To calculate the individual dosage, the level of fibrinogen (functional) must be determined; the
quantity and frequency of administration must be determined in each patient by regularly measuring
plasma fibrinogen levels and continuously monitoring the patient’s clinical condition and other replacement therapies used.
The normal plasma fibrinogen level is between 1.5 and 4.5 g/l. In the presence of congenital hypo- or
afibrinogenemia, the critical plasma fibrinogen level below which bleeding may occur is approximately 0.5-1.0 g/l.
In the case of major surgery, accurate monitoring of replacement therapy using coagulation assays is essential.
Treatment of bleeding and perioperative prophylaxis in patients with congenital hypo- or afibrinogenemia
and a known bleeding tendency.
To treat non-surgical bleeding episodes, it is recommended to increase fibrinogen levels to 1 g/l and maintain fibrinogen at this level until hemostasis is controlled and above 0.5 g/l until complete healing.
To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to increase fibrinogen levels to 1 g/l and maintain fibrinogen at this level until hemostasis is controlled and above 0.5 g/l until complete wound healing.
In the event of a surgical procedure or treatment of non-surgical bleeding, the dose should be calculated as follows:
Dose (g) = [desired level (g/l) – baseline level (g/l)] x 1/recovery (g/l)/(g/kg) x body weight
(kg)
The “1/recovery” ratio is defined based on the patient’s recovery* (see section 5.2), or, if recovery is unknown:

• 0.053 (g/kg)/(g/l) for children and adolescents with a body weight < 40 kg
• 0.043 (g/kg)/(g/l) for adults and adolescents with a body weight ≥ 40 kg.

* Example of patient recovery and dosage calculation
For a 60 kg patient with undetectable baseline fibrinogen levels and an increase in fibrinogen to 1.20 g/l 1 hour after infusion of 0.060 g/kg of Fibriclotte:

• Calculation of patient recovery: 1.20 (g/l)/0.060 (g/kg) = 20.0 (g/l)/(g/kg)
• Calculation of the dose for an increase to 1.0 g/l: 1.0 g/l x 1 / 20.0 (g/l)/(g/kg) [or 0.050 (g/kg)/(g/l)]x 60 kg = 3 g. In an emergency situation when the baseline fibrinogen level is unknown, the recommended initial dose is 0.05 g per kg of body weight, administered intravenously in adults and adolescents with a body weight ≥40 kg and 0.06 g per kg of body weight in pediatric patients with a body weight <40 kg. Subsequent dosage (doses and frequency of injections) should be adjusted based on the patient’s clinical status and laboratory test results.

The biological half-life of fibrinogen is 3-4 days. Therefore, in the absence of consumption, repeated treatment with human fibrinogen is usually not necessary. Taking into account the accumulation that occurs with repeated administration for prophylactic use, the dose and frequency should be established based on the therapeutic goals of the physician for a given patient.
Paediatric population
Recovery and half-life in children and adolescents with a body weight <40 kg is lower than in adults and adolescents with a body weight ≥40 kg (see section 5.2 of the SmPC). Consequently, adapted recovery values should be used to calculate the dose of Fibriclotte in the respective weight groups when the individual patient recovery is unknown. A body weight <40 kg is assumed to cover the age range from birth to approximately 12 years. Dosage (doses and frequency of injections) should be adjusted based on the individual’s clinical response.

Reconstitution:
Use current guidelines for aseptic procedure.

If necessary, bring the two vials (powder and solvent) to
room temperature.

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

Remove the translucent protective film from the
transfer system and fully insert the exposed piercing tip into the center of the solvent vial stopper, with a rotating movement.

Remove the second grey protective film from the other
end of the transfer system.
Invert the solvent vial and quickly press the free end of the piercing tip into the center of
the powder vial stopper to transfer the solvent
into the powder.
Ensure that the piercing tip remains always
immersed in the solvent to avoid premature release of the
vacuum.

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

Remove the empty (solvent) vial with the transfer
system.
Gently shake for a few minutes with a rotating
movement, avoiding foam formation, until the powder is completely
dissolved.

The reconstituted product must be visually inspected before administration to ensure
that it does not contain particulate matter. The reconstituted solution should be almost colorless, slightly
opalescent. Do not use solutions that are cloudy or contain deposits.

Administration:
Fibriclotte must be administered exclusively intravenously, as a single dose,
immediately after reconstitution, at a rate not exceeding 4 ml/min.
The use of an infusion set equipped with a 15 µm filter, such as the one provided in the
pack, is mandatory.
Unused medicine or waste material derived from such medicine must be disposed of in accordance
with local regulations.
This medicine must not be mixed with other medicines and must be administered with
a separate injection/infusion line.