DIAZEPAM Rectal solution (2017)
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Περιεχόμενα
Name of the medicinal product
Diazepam RecTubes 10mg Rectal Solution.
Qualitative and quantitative composition
Diazepam Ph Eur 10mg in 2.5ml (4mg/ml). Excipients: each 2.5ml dose contains Benzoic acid (E210) 2.5mg, Sodium benzoate (E211) 122.5mg and Propylene glycol 1000mg. For the full list of excipients, see ...
Pharmaceutical form
Rectal solution. A clear, colourless or almost yellow solution.
Therapeutic indications
Diazepam has anticonvulsant, sedative, and muscle relaxant properties. It is used in the treatment of severe anxiety and tension states, as a sedative and premedication, in the control of muscle spasm, ...
Posology and method of administration
Posology Sensitivity to diazepam varies with age. Children above 1 year of age: 0.5 mg/kg body weight. Adults: 0.5 mg/kg body weight. Elderly patients: 0.25 mg/kg body weight. A maximum dose of 30 mg diazepam ...
Contraindications
Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section 6.1. Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur). ...
Special warnings and precautions for use
Tolerance Some loss of efficacy to the hypnotic effects of diazepam may develop after repeated use for a few weeks. Dependence Use of benzodiazepines may lead to the development of physical and psychic ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions If diazepam is used with other centrally acting agents, careful consideration has to be given to the pharmacology of the agents employed, particularly with compounds that may ...
Fertility, pregnancy and lactation
In animal studies administration of benzodiazepines during gestation has lead to cleft palate, CNS malformation and permanent functional disturbances in the offspring. Pregnancy There is no evidence as ...
Effects on ability to drive and use machines
Sedation, amnesia, impaired muscular function may adversely effect the ability to drive or use machines. If insufficient sleep occurs, the likelihood of impaired alertness may be increased (see also Interactions). ...
Undesirable effects
Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision predominantly occur at the start of therapy but usually disappear with ...
Overdose
Features The symptoms of diazepam overdose are mainly an intensification of the therapeutic effects (ataxia, drowsiness, dysarthria, sedation, muscle weakness, profound sleep, hypotension, bradycardia, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Diazepam ATC code: N05BA01 Diazepam has anticonvulsant, sedative and muscle relaxant properties. Diazepam binds to specific receptors in the central nervous system and particular ...
Pharmacokinetic properties
After rectal administration of the solution, diazepam is absorbed rapidly and almost completely from the rectum. The onset of the therapeutic effect occurs within a few minutes of rectal administration. ...
Preclinical safety data
Chronic toxicity studies in animals have demonstrated no evidence of drug-induced changes. There are no long-term animal studies to investigate the carcinogenic potential of diazepam. Several investigations ...
List of excipients
Benzyl alcohol Ethanol 96% Propylene glycol Benzoic acid Sodium benzoate Purified Water
Incompatibilities
None known.
Shelf life
Shelf life: Three years. Once foil is opened, use immediately.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light.
Nature and contents of container
Packs of 2 or 5 rectal tubes each containing 2.5ml of solution The tubes are made of low-density polyethylene. The tubes have a nozzle attached for application. Each tube is individually presented in a ...
Special precautions for disposal and other handling
For single use only.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0066
Date of first authorization / renewal of the authorization
06/05/2008
Date of revision of the text
26/04/2017
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