Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Powder I containing hemostasis factors: Human fibrinogen, human fibronectin, Factor XIII, Contained in an amount of total protein of, Powder reconstitution solvent I: Aprotinin of animal origin, Powder II containing the
laboratory: Labo F. Fraction Biotechn
Powder and solvent for glue for surgical use
Box of 2 vials of powder + 1 ml pre-filled syringes
Adjuvant treatment to promote local hemostasis during surgery.
Dosage BIOCOL 1 ml Powder and solvents for glue for surgical use Box of 2 vials of powder + pre-filled syringes of 1 ml
The modalities of application and volume of BIOCOL differ according to the type of surgery performed.
Mode of administration:
BIOCOL is intended for strictly local use.
Application of both components can be done separately or simultaneously (see instructions for use, instructions for handling).
Known hypersensitivity to one of the components of the preparation, in particular to aprotinin of animal origin, constituting one of the reconstitution solvents.
NOT RECOMMENDED :
It is not recommended to use BIOCOL during pregnancy.
Biocol side effects
- There was no adverse reaction described with BIOCOL. It has been described that aprotinin of animal origin, one of its components, can however induce allergic or anaphylactic reactions. In case of shock, symptomatic treatment of shock should be instituted.
- The risk of transmission of infectious agents, including those whose nature is still unknown, can not be definitively excluded when drugs prepared from blood or human plasma are administered.
This risk is however limited by:
. strict controls carried out during the selection of donations by a medical interview with donors and the carrying out of screening tests on each donation, in particular for three major pathogenic viruses, HIV, HCV, HBV;
. the extraction / purification process which includes viral elimination and / or inactivation steps, the capacity of which has been validated for HIV, HCV, HBV, using model viruses.
The efficacy of the viral elimination and / or inactivation, however, remains limited with respect to certain particularly resistant non-enveloped viruses, in particular parvovirus B19.