Lorazepam

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Prenos Lastnosti izdelka (SPC)
22-08-2017

Aktivna sestavina:

lorazepam

Dostopno od:

Arpimed LLC

INN (mednarodno ime):

lorazepam

Odmerek:

2mg

Farmacevtska oblika:

tablets

Tip zastaranja:

Prescription

Lastnosti izdelka

                                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
Lorazepam is indicated for the short term treatment of unacceptable
disabling or distressful anxiety
states including anxiety associated with psychosomatic, organic and
psychotic illness, and the short
term treatment of insomnia associated with anxiety. Lorazepam may also
be used as premedication
before operative dentistry and general surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Dosage and duration of therapy should be individualised. The lowest
effective dose should be
prescribed for the shortest time possible. The risk of withdrawal and
rebound phenomena is greater
after abrupt discontinuation; therefore, the drug should be
discontinued gradually for all patients
(see section 4.4). Generally, the duration of treatment varies from a
few days to 4 weeks including
the
tapering
off
process.
Extension
of
the
treatment
period
should
not
take
place
without
reevaluation of the need for continued therapy.
Increases in the dosage of lorazepam should be made gradually to help
avoid adverse effects. The
evening dose should be increased before the daytime doses.
DOSAGE:
ADULTS:
Moderate and severe anxiety: 1-4 mg daily in divided doses.
Insomnia: 1-2 mg before retiring
Premedication before operative dentistry or general 2-3 mg the night

                                
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