Leaflet ENGERIX B 10mg/0.5ml 10mcg / 0.5ml injection suspension

Product code:
W52082005
Quantity:
1
Indicated for:
prevention of hepatitis B
Route of administration:
injectable
Substance:
hepatitis B vaccine (vaccine)
ATC
J07BC01 — Antiinfectives for systemic use | Viral vaccines | Hepatitis vaccines

Precautions:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light

Store protected from light.

The hepatitis B vaccine is used to prevent infection with the hepatitis B virus (HBV), which can cause acute and chronic hepatitis, liver cirrhosis, and liver cancer. The vaccine contains the hepatitis B surface antigen (HBsAg), produced using recombinant technology, which stimulates the immune system to produce specific antibodies against the virus.

The vaccine is administered intramuscularly, usually in three doses, following a standard schedule (0, 1, and 6 months). It is recommended for all newborns, children, adolescents, and unvaccinated adults, as well as individuals at high risk of infection, such as healthcare workers, dialysis patients, and travelers to endemic areas.

Common side effects include pain at the injection site, mild fever, and fatigue. In rare cases, severe allergic reactions may occur.

The hepatitis B vaccine is an essential measure for preventing HBV infection and its severe complications, contributing to public health protection.

General data about ENGERIX B 10mg/0.5ml 10mcg / 0.5ml

Substance:
hepatitis B vaccine
Date of latest medicines list:
01-06-2026
Product code:
W52082005
Concentration:
10mcg / 0.5ml
Pharmaceutical form:
injection suspension
Packing volume:
0,5ml
Product type:
Original
Price:
48.80 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
GLAXOSMITHKLINE BIOLOGICALS S.A. - BELGIA
Holder:
GLAXOSMITHKLINE BIOLOGICALS S.A. - BELGIA
Number:
6545/2014/05
Shelf life:
3 years

Pharmaceutical forms available for hepatitis B vaccine

Concentrations available for hepatitis B vaccine

  • 100mcg/5ml
  • 10mcg/0.5ml
  • 10mcg/5ml
  • 10mcg/ml
  • 200mcg/10ml
  • 20mcg/ml
  • 40mcg/ml
  • 5mcg/0.5ml

Compensation lists for ENGERIX B 10mg/0.5ml 10mcg / 0.5ml GlaxoSmithKline

E2 - Sublist E - section E2 with 100% discount from the reference price

Price
48.80 RON
Copayment
48.80 RON
Patient
0.00 RON