MODECATE Solution for injection Ref.[7673] Active ingredients: Fluphenazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Modecate Concentrate Injection 100mg/ml.

Pharmaceutical Form

Solution for Injection.

Pale yellow clear, oily liquid.

Qualitative and quantitative composition

Each ampoule contains 100mg/ml of the active substance Fluphenazine Decanoate.

Also contains sesame oil (q.s.).

Benzyl alcohol 15 mg/ml.

For full list of excipients, see section 6.1.

Active Ingredient Description
Fluphenazine

Fluphenazine is an ester of the potent neuroleptic fluphenazine, a phenothiazine derivative of the piperazine type. The ester is slowly absorbed from the intramuscular site of injection and is then hydrolysed in the plasma to the active therapeutic agent, fluphenazine. It is used for the treatment and maintenance of schizophrenic patients and those with paranoid psychoses.
List of Excipients

Benzyl alcohol
Sesame oil

Pack sizes and marketing

Colourless type I glass ampoules with an OPC (one point cut) breaking system containing 0.5ml (packs of 10) and 1ml (packs of 5).

Prefilled syringe with neoprene or pharma-gummi rubber plunger and stopper containing 0.5ml (packs of 10).

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as:

Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0575

Date of first authorisation: 21 March 1996
Date of latest renewal: 23 September 2002

 
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