Biotrombina 400

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

BioTrombina 400

Bovine Thrombin
Powder and solvent for solution for topical use ,400 IU, 200 IU/ml
You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.
for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further questions
• This medicine has been prescribed for you only. Do not pass it on to others.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, you should tell your doctor

Table of contents of the leaflet:

• 1. What is BioTrombina 400 and what is it used for
• 2. Important information before using BioTrombina 400
• 3. How to use BioTrombina 400
• 4. Possible side effects
• 5. How to store BioTrombina 400
• 6. 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 clotting process. It works
in the final phase of the clotting process, i.e. during the conversion of fibrinogen to fibrin and the formation
of a clot.
The medicine, when administered correctly and in the right dose, allows to control bleeding within a few minutes, even in patients with various types of bleeding disorders (except for fibrinogen deficiency) related to the conversion of prothrombin to thrombin (e.g. hemophilia A and B).
BioTrombina 400 is indicated for local hemostasis of intense bleeding:

• from internal organs (stomach, kidneys, lungs) during surgical procedures,
• from the tooth socket after tooth extraction,
• from the nose, mucous membrane of the oral cavity, after tonsillectomy,
• from the reproductive tract during gynecological procedures.

2. Important information before using BioTrombina 400

When not to use BioTrombina 400

• if you are allergic to bovine protein or any of the excipients
• if the bleeding is from large blood vessels
• if the wound is infected

Warnings and precautions

Particular caution should be exercised when using BioTrombina 400, if:

• the patient has been previously treated with medicines containing bovine thrombin or other bovine protein due to the risk of allergic reactions and bleeding complications,
• the patient has afibrinogenemia and dysfibrinogenemia due to reduced or lack of efficacy of the medicine.

Other medicines and BioTrombina 400

The medicine should not be used at the same time as fibrinolytic agents and thrombin inhibitors.
You should inform your doctor about all the medicines you have taken recently, even those that are available without a prescription.

Pregnancy and breastfeeding

There is not enough data on the use of BioTrombina 400 in pregnant and breastfeeding women. The benefits and potential risks of using the medicine should be considered.

Driving and using machines

BioTrombina 400 does not affect the ability to drive and use machines.

3. How to use BioTrombina 400

BioTrombina 400 must not be administered intravascularly.

The dosage is determined by the doctor depending on the intensity of the bleeding.
The powder in the ampoule or vial should be reconstituted with 2 ml of solvent (isotonic sodium chloride solution).
After reconstitution, the solution should be used to soak a sterile swab or sponge and apply it to the wound, or it can be applied directly to the wound.

Overdose:

There is no data on overdose of the medicine.

4. Possible side effects

Like all medicines, BioTrombina 400 can cause side effects.
Bovine thrombin is a protein and can cause the formation of antibodies, which after repeated administration of the medicine may cause allergic reactions and bleeding of varying severity.
The level of antibodies in the patient's blood may increase after each subsequent use of the bovine thrombin product. The resulting antibodies can rarely cause allergic reactions, including anaphylactic reactions. Hives, swelling of the lips, tongue, palate, difficulty breathing associated with swelling of the oral cavity, tongue; wheezing; decreased blood pressure, fainting, generalized hives, swelling, vomiting.
In each case, appropriate treatment should be applied.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Thanks to the reporting of side effects, more information can be collected on the safety of the medicine.

5. How to store BioTrombina 400

The medicine should be stored in a place inaccessible and invisible to children.
The medicine should not be used after the expiry date stated on the packaging.
Store in a refrigerator at 2°C - 8°C.
Reconstituted thrombin in solvent (isotonic sodium chloride solution) is unstable, undergoes partial inactivation and 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 400 contains

One ampoule or vial with powder contains
Bovine thrombin
400 IU
Excipients: glycine
1 ml of solution (after reconstitution in 2 ml of solvent) contains:
Bovine thrombin
200 IU
Excipients: glycine, sodium chloride, water for injections.
One ampoule with solvent (isotonic sodium chloride solution) of 2 ml contains: sodium chloride, water for injections.

What BioTrombina 400 looks like and what the pack contains

What BioTrombina 400 looks like

The powder is uniform, it is a compact, dry mass of white or light beige color.
The solvent is colorless.

Packaging

1 vial with powder of 400 IU and 1 ampoule with solvent of 2 ml.
5 vials with powder of 400 IU and 5 ampoules with solvent of 2 ml.
5 ampoules with powder of 400 IU and 5 ampoules with solvent of 2 ml.

Marketing authorization holder and manufacturer

“BIOMED-LUBLIN” Serum and Vaccine Production Plant Joint Stock Company
20-029 Lublin, ul. Uniwersytecka 10
Phone number: (081) 533 82 21
e-mail: biomed@biomed.lublin.pl

Date of approval of the leaflet: