Lorazepam tablets

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

lorazepam

Доступно од:

Arpimed LLC

АТЦ код:

N05BA06

INN (Међународно име):

lorazepam

Дозирање:

2mg

Фармацеутски облик:

tablets

Јединице у пакету:

(24/1x24/) in blister

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2023-03-21

Карактеристике производа

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