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Human Hepatitis B Immunoglobulin 2500IU/50ml
NAME OF THE MEDICINE
Venbig 50 IU/ml (lọ 50ml)
Human Hepatitis B Immunoglobulin 2500IU/50ml powder and solvent for solution for infusion
COMPOSITION
Human hepatitis B immunoglobulin.
|
|
VENBIG 2500 IU |
|
Human proteins |
50 g/l |
|
of which human immunoglobulin at least to |
95% |
|
antibodies to HBs antigen (anti – HBs) not less than |
2500 IU/vial |
|
antibodies to HBs antigen (anti – HBs) after reconstitution with the solvent not less than |
50 IU/ml
|
IgG subclasses:
IgG1 26.0 – 40.0 mg/ml
IgG2 13.0 – 25.0 mg/ml
IgG3 1.20 – 2.50 mg/ml
IgG4 0.15 – 0.50 mg/ml
Maximum IgA content 0.05 mg/ml
Sodium content: 3.565 mg/ml (0.155 mmoles/ml)
Excipients
Powder vial: Sucrose, Sodium chloride
Solvent vial: Sodium chloride, Water for injections
INDICATIONS
- Prevention of hepatitis B virus recurrence after liver transplantation for hepatitis B virus liver failure in combination with antiviral therapy.
- Immunoprophylaxis of hepatitis B:
- In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown)
- In haemodialysed patients, until vaccination has become effective
- In the newborn of a hepatitis B virus carrier-mother: preferably within 12 hours after birth
- In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B
PRESENTATION
1 Powder vial of 2500 IU
Type I colourless glass vial, with pierceable elastomer stopper and aluminium overseal and plastic flip-off cap, with powder corresponding to 2500 IU of active substance.
1 Solvent vial of 45 ml
Type I neutral glass vial, with pierceable elastomer stopper and aluminium overseal and plastic flip-off cap, with 45 ml of solvent.
Set for the reconstitution and the administration: double needle, sterile set for infusion consists of: plastic tubing with a transparent drop chamber, air filter, flow regulator, perforating needle, infusion needle and a plastic bottle holder device.
MANUFACTURER: PRODUCTION UP TO FRACTION II AND PYROGEN CONTROL ON THE FINISHED PRODUCT
Kedrion S.p.A
Via provinciale (loc. Bolognana) – 55027 – Gallicano (LU) – Italy
MANUFACTURER: PRODUCTION FROM FRACTION II TO BATCH RELEASE
Kedrion S.p.A
S.S.7 Bis Km. 19,5 – 80029 Sant’Antimo – (NA) – Italy
Read the package insert carefully before use.
For any more information, please consult your doctor