DEMETRIN Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
DEMETRIN 10 mg Tablet.
2. Qualitative and quantitative composition
Each tablet contains 10 mg of prazepam. Contains sugar (lactose monohydrate). <u>Excipients with known effect:</u> Each tablet contains 93,73 mg lactose monohydrate. For the full list of excipients, see ...
3. Pharmaceutical form
Tablets. A white, slightly convex tablet with a bisecting score on one side.
4.1. Therapeutic indications
Short-term relief of anxiety-tension states resulting from stressful circumstances, anxiety associated with anxiety neurosis and other psychoneuroses, and as an adjunct in other disease states in which ...
4.2. Posology and method of administration
Posology DEMETRIN is administered orally, usually in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 20 to 60 mg daily in accordance with the response ...
4.3. Contraindications
DEMETRIN is contraindicated in patients with: known hypersensitivity to prazepam, other benzodiazepines or to any excipients of DEMETRIN listed in section 6.1 acute pulmonary insufficiency myasthenia gravis ...
4.4. Special warnings and precautions for use
Duration of treatment The duration of treatment should be as short as possible (see section 4.2). The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially ...
4.5. Interaction with other medicinal products and other forms of interaction
Benzodiazepines, including DEMETRIN, produce additive CNS depressant effects, including respiratory depression, when co-administered with other CNS depressants such as opioids, phenothiazines, narcotics, ...
4.6. Fertility, pregnancy and lactation
Pregnancy DEMETRIN is contraindicated during pregnancy and in women of childbearing potential not using contraception. When DEMETRIN is prescribed to a woman of child-bearing age, the woman should be advised ...
4.7. Effects on ability to drive and use machines
Patients should be advised, particularly at the initiation of therapy, not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery. In these situations, impaired decision making ...
4.8. Undesirable effects
The administration of DEMETRIN is restricted to adults only (18 and above). Tabulated summary of adverse reactions The table below contains side effects categorised as follows utilising the incidence rates: ...
4.9. Overdose
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension. Vomiting should be induced. General supportive care with close observation is ...
5.1. Pharmacodynamic properties
<b>Category and class:</b> A 2.6 Tranquillisers Prazepam is a benzodiazepine derivative with anxiolytic and central muscle relaxant activity. Benzodiazepines exert their effects through enhancement of ...
5.2. Pharmacokinetic properties
Absorption and distribution Prazepam is readily and completely absorbed from the gastro-intestinal tract independently from the gastric pH. The bioavailability of desalkylprazepam due to prazepam is 51 ...
6.1. List of excipients
Maize starch Lactose monohydrate Magnesium stearate Microcrystalline cellulose Silica colloidal anhydrous
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store in a cool, dark (at or below 25ºC) dry place.
6.5. Nature and contents of container
Clear PVC/Aluminium foil blisters of 100 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)
8. Marketing authorization number(s)
G/2.6/188
9. Date of first authorization / renewal of the authorization
Date of first autorisation: 12 November 1975
10. Date of revision of the text
14 September 2022
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