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Beriplast P Combiset powder and solvent for solution for injection

Marketed by Dexa Medica

Ingredients in every vial

Fibrinogen concentrate for Beriplast P (lyophilized powder) 174 mg
Aprotinin solution for Beriplast P (diluent) 1 ml
Human thrombin for Beriplast P (lyophilized powder) 7.6 mg
Calcium chloride solution for Beriplast P (diluent) 1 ml

Each package contains

4 vials of 2 ml

Dosage form

Powder and solvent for solution for injection

Dosage formPowder and solvent for solution for injection

Flavour

None

W.H.O. classification

B02B
B02B

A.T.C. Level 1

Anatomical Main group

B - Blood and blood forming organs
B02B

A.T.C. Level 2

Therapeutic subgroup

B02 - Antihemorrhagics
B02B

A.T.C. Level 3

Pharmacological subgroup

B02B - Vitamin K and Other Hemostatics

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

SAFE IF PRESCRIBEDThis item is safe for use while operating heavy machinery.

Pregnancy

CAUTIONThis item may not be safe for use during pregnancy. Use with caution and after consultation with your doctor.

Lactation

CAUTIONThis item may not be safe for use during lactation. Use with caution and after consultation with your doctor.

Indication

Supportive treatment where standard surgical techniques are insufficient:
For improvement of haemostasis
As a tissue glue to promote adhesion / sealing
As suture support

Dosage

0 TO 18 YEARS OLD
The safety and efficacy of Beriplast in children and adolescents has not yet been established in controlled clinical studies.

18 YEARS OLD AND ABOVE
The volume of Beriplast to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.

The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.

Application of the product must be individualised by the treating physician. The individual dosages have typically ranged from 0.5 to 4 ml. For some procedures (e.g. liver traumata, or the sealing of large burned surfaces) larger volumes (10 ml or more) may be required.

The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary.