Biotrombina 400
Poland
Table of Contents
BioTrombina 400
Bovine Thrombin
Powder and solvent for preparation of solution for topical use, 400 IU, 200 IU/ml
Please read the entire package leaflet before using the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- Consult your doctor or pharmacist if you have any further questions.
- This medicine has been prescribed for a specific individual. Do not pass it on to others.
- If any of the adverse effects worsen or if any adverse effects occur, including those not mentioned in this leaflet, inform your doctor.
Table of contents of the leaflet:
- What is BioTrombina 400 and what is it used for
- Important information before using BioTrombina 400
- How to use BioTrombina 400
- Possible adverse effects
- How to store BioTrombina 400
- Contents of the pack and other information
1. What is BioTrombina 400 and what is it used for
Bovine thrombin is a proteolytic enzyme that catalyzes the blood coagulation process. It acts in the final stage of coagulation by converting fibrinogen into fibrin and forming a clot.
When applied correctly and in the appropriate dose, the medicine can control bleeding within a few minutes, even in patients with various hemorrhagic disorders (except fibrinogen deficiency) related to impaired conversion of prothrombin to active thrombin (e.g., hemophilia A and B).
BioTrombina 400 is indicated for local control of intense bleeding:
- from internal organs (liver, kidneys, lungs) during surgical procedures,
- from tooth socket after tooth extraction,
- from nose, oral mucosa, after tonsillectomy,
- from genital tract during gynecological procedures.
2. Important information before using BioTrombina 400
When not to use BioTrombina 400
- in case of hypersensitivity to bovine protein or to any of the excipients,
- if bleeding originates from large blood vessels,
- if the wound is infected.
Warnings and precautions
Exercise special caution when using BioTrombina 400 if:
- the patient has previously been treated with medicines containing bovine thrombin or other bovine proteins, due to the risk of allergic reactions and hemorrhagic complications,
- the patient has afibrinogenemia or dysfibrinogenemia, as the efficacy of the medicine may be reduced or absent.
Other medicines and BioTrombina 400
BioTrombina 400 must not be used concomitantly with fibrinolytic agents or thrombin inhibitors.
Inform your doctor about all medicines you are currently taking, including those obtained without a prescription.
Pregnancy and breastfeeding
There are insufficient data on the use of BioTrombina 400 in pregnant and breastfeeding women. The benefits and potential risks should be carefully weighed before administration.
Driving and operating machinery
BioTrombina 400 has no effect on the ability to drive or operate machinery.
3. How to use BioTrombina 400
BioTrombina 400 must not be administered intravenously.
Dosage is determined by the physician according to the intensity of bleeding.
Reconstitute the powder in the ampoule or vial with 2 ml of solvent (isotonic sodium chloride solution).
After reconstitution, soak a sterile gauze pad or Spongostan with the solution and apply to the wound, or apply the solution directly to the wound.
Overdose:
There is no data available regarding overdose of this medicine.
4. Possible adverse reactions
Like any medicine, BioTrombina 400 may cause adverse reactions.
Bovine thrombin is a protein and may induce the formation of antibodies, which upon re-administration of the drug may lead to allergic reactions and bleeding of varying severity.
The level of antibodies in the patient's blood may increase with each subsequent use of bovine thrombin.
The antibodies formed may rarely cause allergic reactions, including anaphylactic reactions. Symptoms may include urticaria, itching of the lips, tongue, and palate, breathing difficulties associated with swelling of the oral cavity and tongue; wheezing; drop in blood pressure; fainting; generalized urticaria; itching; vomiting.
In any such case, appropriate treatment should be initiated immediately.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions contributes to the accumulation of additional information on the safety of the medicine.
5. How to store BioTrombina 400
Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiry date stated on the packaging.
Store at 2°C–8°C (in a refrigerator).
Reconstituted thrombin in the solvent (isotonic sodium chloride solution) is unstable and undergoes partial inactivation; therefore, it should be used immediately after reconstitution of the powder.
Batch number (Lot)
Expiry date (EXP)
6. Contents of the pack and other information
What BioTrombina 40 contains
One vial or ampoule of powder contains:
Bovine thrombin 400 IU
Excipients: glycine
1 ml of solution (after reconstitution with 2 ml of solvent) contains:
Bovine thrombin 200 IU
Excipients: glycine, sodium chloride, water for injections.
One ampoule of solvent (sodium chloride isotonic solution) of 2 ml contains:
sodium chloride, water for injections.
What BioTrombina 400 looks like and contents of the pack
What BioTrombina 400 looks like
The powder is homogeneous, forming a compact, dry mass, white or light beige in colour.
The solvent is colourless.
Packaging
1 vial with 400 IU powder and 1 ampoule with 2 ml solvent.
5 vials with 400 IU powder and 5 ampoules with 2 ml solvent.
5 ampoules with 400 IU powder and 5 ampoules with 2 ml solvent.
Marketing authorisation holder and manufacturer
Synthaverse S.A.
20-029 Lublin, ul. Uniwersytecka 10
Tel.: (081) 533 82 21
e-mail: [email protected]