País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lorazepam
Arpimed LLC
N05BA06
lorazepam
2mg
tablets
(24/1x24/) in blister
Prescription
Registered
2018-06-27
SUMMARY PRODUCT CHARACTERISTIC (SPC) LORAZEPAM 1 MG AND 2 MG TABLETS 1.1 BRAND NAME – LORAZEPAM 1.2 INTERNATIONAL NON-PROPERTY NAME - LORAZEPAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Lorazepam 1 mg tablet contains: _ACTIVE INGREDIENT:_ lorazepam - 1 mg _For a full list of excipients, see section 6.1. _ Each Lorazepam 2 mg tablet contains: _ACTIVE INGREDIENT:_ lorazepam - 2 mg _For a full list of excipients, see section 6.1. _ 3. PHARMACEUTICAL FORM _Lorazepam, 1 mg tablets _ White or off white scored cylindrical tablets with a few small darker spots and with a risk on one side and a facet on both sides. _Lorazepam, 2 mg tablets _ White scored cylindrical tablets with a risk on one side and a facet on both sides. 4. CLINICAL PARTICULARS 4.1 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 or short-term psychometric, organic or psychotic illness. As Premedication (adults and children 5 years and above) Before operative dentistry and general surgery Not for use • Long term (i.e. longer than 4 weeks) • For mild/moderate anxiety • For insomnia or anxiety in children 4.2 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 individualized _ Extension of use should not take place without further clinical evaluation Chronic use not recommended (little is known of the long-term safety and efficacy; potential for dependence–see section 4.4). When treatment is started the patient should be informed that • treatment will be of limited duration • the dosage will be progressively decreased • there is a possibility of rebound phenomena Dosage: _ADULTS: _ Anxiety: 1-4mg daily in divided doses. Insomnia: 1-2mg before retiring Premedica Leer el documento completo