PENTACARINAT Powder for reconstitution Ref.[9290] Active ingredients: Pentamidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Pentacarinat 300mg Powder for Solution for Injection/Infusion.

Pharmaceutical Form

Powder for reconstitution.

Sterile, white to almost white powder for use after reconstitution.

Qualitative and quantitative composition

Pentamidine Isetionate 300 mg (Equivalent to 172.4 mg pentamidine base).

Active Ingredient Description
Pentamidine

Pentamidine isetionate is an aromatic diamine. It is an antiprotozoal agent which acts by interfering with DNA and folate transformation, and by the inhibition of RNA and protein synthesis.

List of Excipients

Not applicable.

Pack sizes and marketing

Cardboard carton containing 5 × 10 ml glass vials each with rubber bung and aluminium ring. Each vial contains 300 mg Pentamidine Isetionate BP.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0572

Date of first authorisation: 15 June 1988

Date of latest renewal: 17 January 2003

Drugs

Drug Countries
PENTACARINAT Hong Kong, Malta, Netherlands, New Zealand, United Kingdom

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