Medicinal Products

Beriplast

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Combi-Set I: Vial 1 Fibrinogen concentrate: total amount of dry substance: Fibrinogen, Factor XIII, Vial 2 Aprotinin solution: Aprotinine, Combi-Set II: Vial 3 Thrombin: total amount of dry substance: Thrombin, Bottle 4 (Calcium Chloride Solution): Calcium Chloride
laboratory: Csl Behring Gmbh

Powder and solvent for glue for surgical use
Set of 2 vials of powder + 3 ml suspension vials
All forms

Indication

Beriplast is intended for local use as adjunctive therapy in all surgical procedures where the usual procedures do not allow:

· Improve hemostasis (including endoscopic treatment of peptic ulcer ulcer)

· Promote tissue adhesion / bonding or strengthening of sutures

Posology BERIPLAST Powder and solvents for glue for surgical use Set of 2 vials of powder + vials of suspension of 3 ml

The use of Beriplast is reserved for experienced doctors.

Dosage

The volume of Beriplast to be administered and the frequency of applications should always be determined according to the clinical needs of the patient.

The dose of Beriplast to be administered depends on various parameters, including the type of surgery, the size of the area to be treated, and the mode and number of applications.

The application of Beriplast must be adapted to each individual case by the treating physician. In clinical trials, doses of Beriplast were generally between 0.5 ml and 4 ml per application. In some cases (hepatic injury, extensive burns, etc.), larger volumes (greater than or equal to 10 ml) were required.

The initial volume of Beriplast to be deposited on the anatomical site or the chosen surface must be sufficient to completely cover the area concerned. The application can be renewed if necessary.

Method and route of administration

Intralesional way.

Prepare solutions as indicated in the section Special precautions for disposal and other handling .

Reconstituted solutions (from vials 1 and 3) are intended for local application (sequential or simultaneous). Unlike other hemostatic agents that must be removed after haemostasis, Beriplast is maintained locally after application and is degraded by the physiological process of clot lysis.

Before applying Beriplast, the wound surface should be as dry as possible.

For further clarification, see Special Precautions for Disposal and Handling .

Against indications

Beriplast should not be administered intravascularly.

Arterial haemorrhages and major venous bleeding.

Known hypersensitivity to bovine proteins or other components of the product.

Beriplast side effects

The following standard categories of frequency are used:

Very common: ≥ 1/10

Frequency: ≥ 1/100 and <1/10

Uncommon: ≥ 1/1000 and <1/100

Rare: ≥ 1/10 000 and <1/1000

Very rare: <1 / 10, 000 (of which isolated cases)

Immune system disorders

In very rare cases, hypersensitivity or allergic reactions (dyspnea, rash / rash, urticaria, hypotension, bronchospasm) may occur. In a few isolated cases, these reactions resulted in anaphylactic shock. These reactions usually occur with repeated application or administration to patients with a history of hypersensitivity to bovine proteins or other components of the product.

For information on the risk of infection see section Special warnings and precautions for use . "Viral safety"

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