CLONAZEPAM THAME Oral solution (2018)
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Περιεχόμενα
Name of the medicinal product
Clonazepam Thame 0.5mg/5ml Oral Solution.
Qualitative and quantitative composition
Each 5ml solution contains 0.5mg Clonazepam. Excipients with known effect: Each 5ml solution contains 64.68mg of ethanol (96%). For the full list of excipients, see section 6.1.
Pharmaceutical form
Oral Solution. Clear, colourless to pale yellow colour solution.
Therapeutic indications
All clinical forms of epileptic disease and seizures in adults, especially absence seizures (petit mal) including atypical absence; primary or secondarily generalised tonic-clonic (grand mal), tonic or ...
Posology and method of administration
Posology The 0.5mg/5ml oral solution facilitates the administration of lower daily doses in the initial stages of treatment. The 2mg/5ml solution should be used for maintenance and maximum dosage regimens. ...
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 ...
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 ...
Interaction with other medicinal products and other forms of interaction
Not recommended In combination with clonazepam, alcohol may modify the effects of the drug, compromise the success of therapy or give rise to unpredictable side-effects (see also section 4.4). See section ...
Fertility, 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 ...
Effects on ability to drive and use machines
As a general rule, epileptic patients are not allowed to drive. Even when adequately controlled on clonazepam, it should be remembered that any increase in dosage or alteration in timings of dosage may ...
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. Angioedema may occur in rare cases. Endocrine ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Benzodiazepine derivatives ATC code: N03AE01 Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing ...
Pharmacokinetic properties
Absorption Clonazepam is quickly and completely absorbed after oral administration. Peak plasma concentrations are reached in most cases within 1–4 hours after an oral dose. Bioavailability is 90% after ...
Preclinical safety data
Carcinogenicity Conventional studies of carcinogenic potential have not been conducted with clonazepam. However, in an 18-month chronic study in rats no treatment-related histopathological changes were ...
List of excipients
Ethanol (96%) Medium chain triglycerides
Incompatibilities
In absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 24 months. Discard 30 days after first opening.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Keep the bottle tightly closed. Keep the bottle in the outer carton in order to protect from light.
Nature and contents of container
Bottle: Ph. Eur. Type III Amber glass bottle. Closure: a tamper-evident, child-resistant plastic cap with polypropylene inner, polyethylene outer and expanded polyethylene (EPE) liner. Dosing Device: a ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Syri Limited t/a Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK
Marketing authorization number(s)
PL 39307/0052
Date of first authorization / renewal of the authorization
03/08/2017
Date of revision of the text
05/06/2018
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