Fibclot 1,5 g powder and solvent for solution for injection and for infusion
SpainTable of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
FibCLOT 1.5 g
Powder and solvent for injectable solution and for infusion
human fibrinogen
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What FibCLOT is and what it is used for
- What you need to know before using FibCLOT
- How to use FibCLOT
- Possible side effects
- How to store FibCLOT
- Contents of the pack and other information
1. What FibCLOT is and what it is used for
What FibCLOT is
FibCLOT is a medicine that belongs to the group of antihemorrhagic agents. The active substance is human fibrinogen, a protein naturally present in the body. This protein's function is to ensure normal blood coagulation and to prevent bleeding from lasting too long.
What FibCLOT is used for
FibCLOT is used in all age groups to compensate for a deficiency in human fibrinogen and thereby treat bleeding (hemorrhages) in patients with congenital fibrinogen deficiency.
Congenital fibrinogen deficiency is an inherited disorder characterized by lower than normal levels or the absence of a protein called fibrinogen. This deficiency may lead to prolonged bleeding.
2. What you need to know before using FibCLOT
Do not use FibCLOT
If you are allergic to the active substance (human fibrinogen) or to any of the other ingredients of this medicine (listed in section 6. "Contents of the pack and other information").
Inform your doctor if you are allergic to any medicines.
Warnings and precautions:
Talk to your doctor, pharmacist, or nurse before starting to use FibCLOT.
Traceability
In order to improve the traceability of biological medicines, the name and batch number of the administered medicine should be clearly documented.
Risk of blood clots
High doses or repeated administrations of this medicine may increase the risk of blood clots in blood vessels.
Therefore, your doctor must weigh the benefits of this medicine against the risk of blood clots, especially:
- If you have had a heart attack (history of coronary heart disease or myocardial infarction).
- If you have liver disease.
- If you have recently undergone surgery.
- If you are about to undergo surgery.
- In newborns (neonates).
- If you have a higher than normal risk of developing blood clots.
Your doctor may request additional tests to monitor this risk.
Risk of allergic reactions
Your doctor will inform you about the warning signs of an allergic reaction or a severe allergic reaction (anaphylactic reaction) (see section 4. "Possible side effects"). If any of these symptoms occur, administration of this medicine must be stopped immediately.
Viral safety
This medicine is made from human plasma (the liquid part of blood).
When medicines derived from human blood or plasma are manufactured, certain measures are taken to prevent the transmission of infections to patients. Some of these measures include:
- Careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded,
- Testing of each donation and plasma pools for signs of viral infections,
- Inclusion of steps in the manufacturing process that can inactivate or remove viruses.
Despite these measures, when medicines derived from human blood or plasma are administered, the possibility of transmitting an infection cannot be completely ruled out. This also applies to unknown or emerging viruses and other types of infections.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV or AIDS virus), hepatitis B virus, and hepatitis C virus, as well as against the non-enveloped hepatitis A virus.
The measures taken may have limited effectiveness against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be severe in pregnant women (fetal infection) and in individuals with weakened immune systems or certain types of anemia (e.g., sickle cell disease or hemolytic anemia).
If you receive human plasma-derived products regularly/repeatedly, your doctor may recommend that you consider vaccination against hepatitis A and B.
Immunological risk
Immune reactions have been observed during replacement therapy with coagulation factors in the context of other congenital deficiencies, but data on fibrinogen are lacking.
Children and adolescents
The above-mentioned warnings and precautions apply to children and adolescents.
Use of FibCLOT with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
No interactions between this treatment and other medicines have been observed to date. However, this medicine must not be mixed with other products and/or medicines.
Pregnancy and breastfeeding
- If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. This medicine should only be used during pregnancy and breastfeeding on the advice of your doctor.
- Consult your doctor if you find out you are pregnant during treatment, as only your doctor can determine whether you need to continue treatment.
Driving and using machines
This medicine has no influence on the ability to drive or use machines.
FibCLOT contains sodium.
This medicine contains up to 3 mmol (or 69 mg) of sodium (the main component of table salt) per vial. This amount corresponds to 3.45% of the maximum daily recommended sodium intake for an adult.
If you are on a low-salt diet, you should take this into account.
3. How to use FibCLOT
Treatment must be initiated under the supervision of a physician experienced in the management of congenital fibrinogen deficiency.
Dosage
Your doctor will determine the appropriate dose and frequency, which will depend on the following factors:
- your body weight,
- the severity of your disorder,
- the location and extent of bleeding, or the nature of your surgical procedure,
- your overall health status.
Your doctor will recommend that you undergo blood tests during treatment to monitor your fibrinogen levels.
Depending on the test results, your doctor may decide to adjust the dose and frequency of injections.
Frequency of administration
Your doctor will determine how often the injections should be administered.
Additionally, the number of injections will be adjusted according to the severity of bleeding and the treatment's effectiveness.
Information regarding the frequency and duration of treatment in various situations is provided in the section for healthcare professionals at the end of this leaflet.
Method of administration:
This medicine is to be injected into a vein. A perfusion set with a 15 µm filter, such as the one supplied with the pack, must be used.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
If you use more FibCLOT than you should
To avoid the risk of overdose, your doctor will perform periodic blood tests to monitor your fibrinogen levels.
In case of overdose, the risk of abnormal blood clot formation cannot be ruled out.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The most serious adverse effects are:
- Allergic reactions: as with any intravenous protein product, allergic reactions may occur. In some cases, these reactions have worsened and become severe allergic reactions, sometimes with a marked drop in blood pressure (anaphylactic shock).
Warning signs of allergic reactions include:
- burning and tingling sensation at the injection site,
- tingling,
- redness, itching, and rash,
- hives,
- skin swelling,
- paleness,
- swelling of the face or throat,
- cough,
- wheezing (similar to asthma-like wheezing),
- chest tightness,
- rapid heart rate,
- low blood pressure,
- extreme tiredness (lethargy),
- restlessness,
- chills,
- feeling unwell (nausea), vomiting,
If any of these effects occur, contact a doctor immediately, who will discontinue treatment with this medicine and/or initiate appropriate treatment depending on the type and severity of the reaction. |
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Blood clots: Blood clots may form in the bloodstream. These can cause:
-
a heart attack, warning signs of which are sudden chest pain or difficulty breathing;
-
a stroke, warning signs of which are sudden onset of muscle weakness, loss of sensation and/or balance, decreased level of consciousness, or difficulty speaking;
-
a serious condition called pulmonary embolism (a blood clot blocking an artery in the lungs), warning signs of which are chest pain, difficulty breathing, or coughing up blood;
-
a clot in a vein (venous thrombosis), warning signs of which are redness, warmth, pain, tenderness to touch, or swelling in one or both legs.
If any of these effects occur, contact a doctor immediately, who will discontinue treatment with this medicine and/or initiate appropriate treatment depending on the type and severity of the reaction. |
The following adverse effects are frequent (may affect up to 1 in every 10 infusions):
- headache.
The following adverse effects are uncommon (may affect up to 1 in every 100 infusions):
- allergic reaction (such as anaphylactic shock, pallor, vomiting, cough, low blood pressure, chills, urticarial rash [urticaria]; see also section "Allergic reactions"),
- dizziness,
- vomiting (associated with headache),
- tinnitus (ringing in the ears),
- blood circulation disorders (deep vein thrombosis, superficial phlebothrombosis),
- breathing difficulty (asthma),
- skin rash, skin redness, skin irritation, night sweats,
- sensation of heat.
Children and adolescents
The frequency, type, and severity of adverse effects are similar in pediatric patients (from birth up to and including 17 years of age) and adults, except for allergic or anaphylactic-type reactions, which occurred more frequently in the pediatric population.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of FibCLOT
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month indicated.
Do not store above 25 °C. Do not freeze.
Keep the vial in the outer packaging to protect it from light and moisture.
The product should be used immediately after reconstitution. Do not store the reconstituted product.
Do not use this medicine if the reconstituted solution is cloudy or contains sediment.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Pack contents and additional information
Composition of FibCLOT
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 components are arginine hydrochloride, isoleucine, lysine hydrochloride, glycine, sodium citrate dihydrate and solvent (water for injections).
Appearance of the medicinal product and contents of the container
This medicine is presented as a powder accompanied by solvent for solution for injections in glass vials, a transfer device and an infusion set with a 15 µm filter.
The reconstituted solution should be practically colourless and slightly opalescent (should have a pearly sheen).
Marketing Authorization Holder:
Laboratoire français du Fractionnement et des Biotechnologies
Tour W – 102 Boieldieu 19th Floor, 92800 Puteaux, FRANCE
Tel.: +33(0) 1 69 82 70 10
Fax: +33(0) 1 69 82 19 03
Manufacturer responsible:
LFB BIOMEDICAMENTS
59 rue de Trévise, 59000 Lille, FRANCE
More information about this medicine can be requested from the local representative of the Marketing Authorization Holder:
LFB BIOTERAPIAS HISPANIA
C/ Diego de León 47
28006 Madrid
(Spain)
This medicine is authorized in the Member States of the European Economic Area under the following names:
Germany, Austria, Spain, Greece, United Kingdom: FibCLOT
Denmark, Finland, Hungary, Luxembourg, Norway, Netherlands, Sweden: Fibclot
Belgium: Fibclot 1.5 g, powder and solvent for solution for injection/for infusion
Italy: Fibriclotte
Date of latest review of this leaflet: 06/2024
This information is intended for healthcare professionals only:
Treatment must be initiated under the supervision of a physician experienced in the treatment of coagulation disorders.
Dosage
The dose and duration of replacement therapy depend on the severity of the disorder, the location and extent of bleeding, as well as the patient's clinical condition.
Fibrinogen (functional) concentration should be determined in order to calculate the individual dose; furthermore, the amount and frequency of administration should be calculated for each individual patient by periodic determination of plasma fibrinogen concentration and continuous monitoring of the patient's clinical status and other replacement therapies used.
Normal plasma fibrinogen concentration ranges between 1.5 and 4.5 g/L. In congenital hypo- or afibrinogenemia, the critical plasma fibrinogen concentration below which bleeding may occur is approximately 0.5 to 1.0 g/L.
In the case of major surgery, replacement therapy must be monitored using coagulation assays.
Treatment of bleeding episodes and perioperative prophylaxis in patients with congenital hypo- or afibrinogenemia and known bleeding tendency.
For treatment of non-surgical bleeding episodes, it is recommended to increase fibrinogen concentration to 1 g/L and maintain this concentration until hemostasis is controlled, and above 0.5 g/L until healing is complete.
To prevent excessive bleeding during surgical procedures, prophylactic treatment is recommended to increase fibrinogen concentration to 1 g/L and maintain this concentration until hemostasis is controlled, and above 0.5 g/L until healing is complete.
For surgical procedures or treatment of non-surgical bleeding, the dose should be calculated as follows:
Dose (g) = [desired concentration (g/L) - baseline concentration (g/L)] x 1/recovery (g/L) (g/kg) x body weight (kg)
The "1/recovery ratio" is defined by the patient's recovery* (see section 5.2 of the Summary of Product Characteristics), or if recovery is unknown:
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0.053 (g/kg)/(g/L) for children and adolescents <40 kg body weight
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0.043 (g/kg)/(g/L) for adults and adolescents ≥40 kg body weight.
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Example of patient recovery and dose calculation
For a 60 kg patient with undetectable baseline fibrinogen concentration and an increase in fibrinogen to 1.20 g/L one hour after infusion of 0.060 g/kg of FibCLOT:
- Calculation of patient recovery:
1.20 (g/L) / 0.060 (g/kg) = 20.0 (g/L)/(g/kg)
- Calculation of 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 where baseline fibrinogen concentration is unknown, the recommended initial dose is 0.05 g per kg body weight administered intravenously in adults and adolescents ≥40 kg body weight, and 0.06 g/kg body weight in pediatric patients <40 kg body weight.
Subsequent dosing (dose and frequency of infusions) should be adjusted according to the patient's clinical condition and laboratory results.
The biological half-life of fibrinogen is between 3 and 4 days. Therefore, if there is no consumption, repeated treatment with human fibrinogen is usually not necessary. Considering the accumulation that may occur with repeated administration for prophylactic purposes, the dose and frequency should be determined based on the physician's therapeutic goals for each individual patient.
Pediatric population
Recovery and half-life in children and adolescents <40 kg body weight are lower than in adults and adolescents ≥40 kg body weight (see section 5.2 of the Summary of Product Characteristics). Therefore, adjusted recovery values should be used to calculate the dose of FibCLOT in the respective body weight groups when individual patient recovery is unknown. A body weight of <40 kg is considered to cover the age range from birth to approximately 12 years. Dosage (dose and frequency of infusions) should be adjusted according to the individual patient's clinical response.
Reconstitution:
Follow current guidelines for aseptic procedures.
| If necessary, warm both vials (powder and solvent) until they reach room temperature. |
| Remove the protective caps from the solvent vial and the powder vial. |
| Remove the translucent protective sheath from the transfer device and, by rotating motion, fully insert the exposed spike into the center of the solvent vial stopper. |
| Remove the second grey protective sheath from the other end of the transfer device. |
| During transfer, perform a gentle horizontal swirling motion so that the solvent stream spreads across the entire surface of the powder and the vial wall. Ensure all the solvent is transferred. |
| Remove the empty solvent vial with the transfer device. |
Before administering the reconstituted product, it should be visually inspected for the presence of particles. The reconstituted solution should be practically colorless and slightly opalescent. Do not use solutions that are cloudy or contain sediment.
Administration:
FibCLOT must be administered only intravenously, as a single dose, immediately after reconstitution and at a rate not exceeding 4 mL/min.
Use of an infusion set with a 15 µm filter, such as the one supplied with the package, is mandatory.
Disposal of unused medication and of all materials that have come into contact with it must be carried out in accordance with local regulations.
This medicine must not be mixed with other medicinal products and should be administered using a separate injection/infusion catheter.