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
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. |
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 Solvent for parenteral use: Water for injections |
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.
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
PA 0050/014/003
Date of first authorisation: 01 April 1977
Date of last renewal: 01 April 2007
| Drug | Countries | |
|---|---|---|
| RIVOTRIL | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Romania, Turkey, South Africa |
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