RIVOTRIL Concentrate for solution for injection / infusion Ref.[28153] Active ingredients: Clonazepam

Source: Health Products Regulatory Authority (IE)  Revision Year: 2014  Publisher: Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Product name and form

Rivotril 1 mg/ml Concentrate for solution for injection or infusion.

Pharmaceutical Form

Concentrate for solution for injection or infusion supplied with a solvent for parenteral use.

A clear, colourless to slightly green-yellow solution.

Qualitative and quantitative composition

Each ampoule contains 1mg clonazepam in 1ml solution.

Excipients: Also contains 30mg benzyl alcohol and 159mg/ml Ethanol.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Clonazepam

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absence seizures (petit mal), slow spike wave, generalised spike wave, spikes with temporal or other locations as well as irregular spikes and waves.

List of Excipients

Active substance ampoule:

Ethanol absolute
Glacial acetic acid
Benzyl alcohol
Propylene glycol

Solvent for parenteral use:

Water for injections

Pack sizes and marketing

5 or 10 × 2 ml amber glass ampoules each containing 1 ml active concentrate containing 1mg clonazepam.

5 or 10 × 1 ml clear glass ampoules each containing 1 ml of solvent for parenteral use.

Not all pack sizes may be marketed.

Marketing authorization holder

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Marketing authorization dates and numbers

PA 0050/014/003

Date of first authorisation: 01 April 1977
Date of last renewal: 01 April 2007

Drugs

Drug Countries
RIVOTRIL Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Romania, Turkey, South Africa

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