RIVOTRIL Concentrate for solution for injection / infusion (2014)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

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

2. 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.

3. Pharmaceutical form

Concentrate for solution for injection or infusion supplied with a solvent for parenteral use. A clear, colourless to slightly green-yellow solution.

4.1. Therapeutic indications

Administered intravenously, Rivotril quickly controls status epilepticus in all clinical forms.

4.2. Posology and method of administration

Rivotril sterile concentrate is for intravenous administration. For the treatment of status epilepticus, the dose and rate of administration are governed by the response of the patient. Adults 1mg (one ...

4.3. Contraindications

Patients with known sensitivity to benzodiazepines or any of the drugs excipients; acute pulmonary insufficiency, severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, severe hepatic ...

4.4. Special warnings and precautions for use

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs ...

4.5. Interaction with other medicinal products and other forms of interaction

Since alcohol can provoke epileptic seizures, irrespective of therapy, patients must under no circumstances drink alcohol while under treatment with antiepileptic drugs. In combination with Rivotril, alcohol ...

4.6. Pregnancy and lactation

Preclinical studies in animals have shown reproductive toxicity and from preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations (see section ...

4.7. Effects on ability to drive and use machines

As a general rule, epileptic patients are not allowed to drive. Even when adequately controlled on Rivotril, it should be remembered that any increase in dosage or alteration in timings of dosage may modify ...

4.8. Undesirable effects

The following have been observed: Immune System Disorders: Allergic reactions and very rare cases of anaphylaxis have been reported to occur with benzodiazepines. Endocrine Disorders: Isolated ...

4.9. Overdose

Symptoms The symptoms of overdosage or intoxication vary greatly from person to person depending on age, bodyweight and individual response. Benzodiazepines commonly cause drowsiness, ataxia, dysarthria ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Benzodiazepine derivative ATC code: N03AE01 Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, ...

5.2. Pharmacokinetic properties

Absorption Clonazepam is quickly and completely absorbed after oral administration of Rivotril. Peak plasma concentrations are reached in most cases within 1-4 hours after an oral dose. Bioavailability ...

5.3. Preclinical safety data

Carcinogenicity No 2-year carcinogenicity studies have been conducted with clonazepam. However, in an 18-month chronic study in rats no treatment-related histopathological changes were seen up to the highest ...

6.1. List of excipients

Active substance ampoule: Ethanol absolute Glacial acetic acid Benzyl alcohol Propylene glycol Solvent for parenteral use: Water for injections

6.2. Incompatibilities

Do not prepare Rivotril infusions using sodium bicarbonate solution, as otherwise precipitation of the solution may occur.

6.3. Shelf life

Unopened ampoules: 4 years. Shelf-life of diluted product: from a chemical and physical stability point of view, the diluted product is stable up to 12 hours. However, it should be used immediately ...

6.4. Special precautions for storage

Do not store above 30ºC. Keep the ampoules in the outer carton in order to protect from light.

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements. Preparation of intravenous injection: The contents of the solvent ampoule, which contains 1ml Water ...

7. Marketing authorization holder

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

8. Marketing authorization number(s)

PA 0050/014/003

9. Date of first authorization / renewal of the authorization

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

10. Date of revision of the text

January 2014

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