Leaflet ONKO BCG 100 100mg / ml powder and solvent for intravesical suspension

Indicated for: prevention of tuberculosis

Route of administration: intravesical

Substance: BCG vaccine (vaccine)

ATC: L03AX03 (Antineoplastic and immunomodulating agents | Immunostimulants | Other immunostimulants)

Precautions:
Anaphylaxis
Anaphylaxis

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

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid live vaccines
Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Refrigerated storage
Refrigerated storage

Store in the refrigerator as instructed in the leaflet.

Protect from light
Protect from light

Store protected from light.

The BCG vaccine (Bacillus Calmette-Guérin) is a vaccine used to prevent tuberculosis (TB), particularly severe forms such as tuberculous meningitis and miliary tuberculosis in children. It is derived from an attenuated strain of Mycobacterium bovis, a close relative of the bacterium that causes TB.

The BCG vaccine is typically administered intradermally within the first days or months of life, especially in countries where tuberculosis is endemic. While it does not provide complete protection against all forms of TB, it is effective in reducing the risk of severe complications in children.

Side effects are generally mild and include redness, swelling, or a small lesion at the injection site, which heals within a few weeks. Rarely, local lymphadenopathy or more severe infections may occur, particularly in individuals with immunodeficiencies.

The BCG vaccine is not recommended for individuals with severe immunodeficiencies (such as those caused by HIV) or those undergoing immunosuppressive treatments. Administration should be performed by qualified medical personnel in accordance with national vaccination guidelines.

General data about ONKO BCG 100 100mg / ml

  • Substance: BCG vaccine
  • Date of latest medicines list: 01-06-2026
  • Product code: W70117003
  • Concentration: 100mg / ml
  • Pharmaceutical form: powder and solvent for intravesical suspension
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 1131.42 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: SYNTHAVERSE S.A. - POLONIA
  • Holder: ANISAPHARM DISTRIBUTION S.R - ROMANIA
  • Number: 8/2024/03
  • Shelf life: 2 years

Concentrations available for BCG vaccine

  • 0.05mg/dose
  • 100mg
  • 100mg/ml
  • 2-8X10^8 UFC BCG Tice
  • 5X10^8 UFC BCG Tice
  • 75mg/ml
  • 81mg

Compensation lists for ONKO BCG 100 100mg / ml Anisapharm Distribution

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

1131.42 RON

1131.42 RON

0.00 RON