ONCOTICE Powder for instillation fluid for intravesical use Ref.[8240] Active ingredients: BCG vaccine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Product name and form

OncoTICE powder for instillation fluid for intravesical use containing 2-8 × 10⁸ CFU Tice BCG.

Pharmaceutical Form
Powder for instillation fluid for intravesical use.

Qualitative and quantitative composition

OncoTICE BCG 12.5mg per vial containing 2-8 × 108 CFU Tice BCG.

After reconstitution in 50 ml saline the suspension contains 0.4-1.6 × 10⁷ CFU/ml.

OncoTICE is a freeze-dried preparation containing attenuated bacilli of Mycobacterium bovis, prepared from a culture of Bacillus Calmette-Guérin (BCG). For excipients, see section 6.1.

Active Ingredient	Description
BCG vaccine	BCG vaccine is an immunostimulating agent. It has anti-tumor activity, but the exact mechanism of action is not known.

List of Excipients
Lactose Asparagine Citric acid (E330) Dibasic potassium phosphate Magnesium sulfate Iron ammonium citrate Glycerol (E422) Zinc formate Ammonium hydroxide (E527)

Pack sizes and marketing

2 ml Type 1 glass vials in packs of 1 and 3.

Marketing authorization holder

Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK

Marketing authorization dates and numbers

PL 53095/0003

28 April 1998/28 April 2003

Drugs

Drug	Countries
ONCOTICE	Austria, Australia, Canada, Cyprus, Spain, Israel, New Zealand, Poland, Turkey, United Kingdom

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