LORAZEPAM Tablets (2018)
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Περιεχόμενα
Name of the medicinal product
Lorazepam 1mg Tablets.
Qualitative and quantitative composition
Lorazepam 1mg Tablets contain 1mg of the active ingredient lorazepam. Lorazepam (INN, BAN) is chemically defined as 7-chloro-5-(0-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.
Pharmaceutical form
Lorazepam 1mg Tablets are blue, capsule-shaped tablets, measuring approximately 4 8mm, plain on one face and gp breakbar 19 on the other.
Therapeutic indications
For short term (2-4 weeks only) use (adults only) Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia ...
Posology and method of administration
Route of administration Oral. Treatment to be given: Under close medical supervision. At the lowest effective dose. For the shortest possible duration (not exceeding 4 weeks). Doses should be individualised. ...
Contraindications
Hypersensitivity to benzodiazepines or to any of the other ingredients. Acute pulmonary insufficiency: respiratory depression; sleep apnoea (risk of further respiratory depression). Obsessional states ...
Special warnings and precautions for use
Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence of Lorazepam, these substances should either be avoided or taken in reduced ...
Interaction with other medicinal products and other forms of interaction
Not recommended Alcohol Lorazepam should not be used together with alcohol (enhanced sedative effects; impaired ability to drive/operate machinery). Sodium oxybate Avoid concomitant use (enhanced effects ...
Pregnancy and lactation
Pregnancy Benzodiazepines should not be used during pregnancy, especially during the first and last trimesters. Benzodiazepines may cause foetal damage when administered to pregnant women. If the drug ...
Effects on ability to drive and use machines
Patients should be advised that sedation, amnesia, impaired concentration, dizziness, blurred vision and impaired muscular function may occur and that, if affected, they should not drive or to use machines, ...
Undesirable effects
Adverse reactions, when they occur, are usually observed at the beginning of therapy and generally decrease in severity or disappear with continued use or upon decreasing the dose. Most frequently reported ...
Overdose
In the management of overdose with any drug, it should be borne in mind that multiple agents may have been taken. Overdose of benzodiazepines is usually manifested by degrees of central nervous system ...
Pharmacodynamic properties
Lorazepam is a benzodiazepine with anxiolytic, sedative and hypnotic properties.
Pharmacokinetic properties
Lorazepam is almost completely absorbed from the gastrointestinal tract and peak serum levels are reached in 2 hours. It is metabolised by a simple one-step process to a pharmacologically inert glucuronide. ...
Preclinical safety data
Oesophageal dilation occurred in rats treated with lorazepam for more than one year at 6mg/kg/day.
List of excipients
Lactose 72 mesh Lactose powdered anhydrous Microcrystalline cellulose Polacrilin potassium Magnesium stearate Colouring: E132
Incompatibilities
None known.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store in a cool, dry place.
Nature and contents of container
Blister packs of PVC backed by hard tempered aluminium foil: Pack sizes of 28, 30, 56, 60 or 100 tablets. Opaque polypropylene Securitainers with opaque polythene caps: Pack sizes of 28, 30, 56, 60, 100, ...
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Genus Pharmaceuticals Holdings Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Marketing authorization number(s)
PL 17225/0010
Date of first authorization / renewal of the authorization
1 September 1999
Date of revision of the text
21/09/2018
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