PROMAZINE HYDROCHLORIDE Oral syrup (2016)
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Περιεχόμενα
Name of the medicinal product
Promazine Hydrochloride 25mg/5ml Oral Syrup.
Qualitative and quantitative composition
Promazine Hydrochloride 25mg/5ml.
Pharmaceutical form
Oral Syrup.
Therapeutic indications
As an adjunct to short-term management of moderate to severe psychomotor agitation. Agitation and restlessness in the elderly.
Posology and method of administration
Posology For oral administration only. Dosage varies with the individual and the purpose for which the drug is used, so the following dosages are only for general guidance with regard to possible effectiveness ...
Contraindications
Use in patients hypersensitive to the active ingredient or other phenothiazines. Use in patients in coma or CNS depression. Use in patients with bone marrow depression. Use in patients with phaeochromocytoma. ...
Special warnings and precautions for use
Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the ...
Interaction with other medicinal products and other forms of interaction
The concomitant administration of this product with other medication such as central nervous system depressants (including alcohol and anaesthetics) or antihypertensives, opioids, anticholinergic or dopaminergic ...
Pregnancy and lactation
Do not use during pregnancy, especially during the first three months, unless there are compelling reasons. There is insufficient evidence of the safety of Promazine in human pregnancy nor is there evidence ...
Effects on ability to drive and use machines
Phenothiazines may impair alertness and induce drowsiness especially at the start of treatment. Alcohol and many other drugs (see section 4.5) may enhance these effects and impair the ability to drive. ...
Undesirable effects
Promazine is a member of the phenothiazine group of drugs and the size effects associated with that group have been noted. Blood and lymphatic system disorders: Sensitivity reactions including agranulocytosis, ...
Overdose
Ingestion of large amounts of Promazine is followed by deep sleep, with or without a pronounced fall in blood pressure and without particular change in respiration rate, other than the slowing attendant ...
Pharmacodynamic properties
Promazine has a wide range of activity arising from its depressant actions on the central nervous system and its alpha-adrenergic blocking and weaker anticholinergic activities. It is a dopamine inhibitor; ...
Pharmacokinetic properties
Promazine is readily absorbed from the gastro-intestinal tract but is subject to considerable first-pass metabolism in the gut wall. It is also extensively metabolised in the liver and is excreted in the ...
Preclinical safety data
None stated.
List of excipients
Propylene glycol (E1520) Methyl hydroxybenzoate (E218) Ethyl hydroxybenzoate (E214) Propyl hydroxybenzoate (E216) Sucrose Liquid glucose Ascorbic acid (E300) Green lemon flavour 545489E Purified water ...
Incompatibilities
None known.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Store below 25°C. Protect from light.
Nature and contents of container
Bottle: Amber (type III) glass bottle Capacity: 150ml Closure: HDPE, EPE wadded, tamper evident, child resistant closure.
Special precautions for disposal and other handling
Dispense in amber glass bottles. If a dose of under 5ml is required, the oral syrup should be administered using an oral dosing device.
Marketing authorization holder
Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE
Marketing authorization number(s)
PL 0427/0054
Date of first authorization / renewal of the authorization
5.2.82 / 24.3.95/5.4.02
Date of revision of the text
04/05/2016
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