Diazepam Alkaloid solution for injection

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

diazepam

Pieejams no:

Alkaloid AD Skopje

ATĶ kods:

N05BA01

SNN (starptautisko nepatentēto nosaukumu):

diazepam

Deva:

10mg/2ml

Zāļu forma:

solution for injection

Vienības iepakojumā:

(10) ampoules 2ml

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2021-06-29

Produkta apraksts

Diazepam Alkaloid 10 mg/2 ml solution for injection
_ _
Summary of Product Characteristics
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diazepam Alkaloid 10 mg/2 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml solution for injection (1 ampoule) contains 10 mg diazepam.
Excipients with known effect:
Each ampoule contains 4.80 mg benzoic acid; 40 mg sodium benzoate; 100
mg benzyl
alcohol; 200 mg ethanol, anhydrous; 900 mg propylene glycol and
6.384 mg sodium
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
solution for injection
Clear light yellow to greenish solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute anxiety and agitation, abstinence syndrome (delirium tremens),
status epilepticus,
tetanus, acute central and peripheral muscle spasms.
Anesthesia: pre-medication, introduction of anesthesia, cardioversia,
minor surgical
procedures, endoscopy.
Obstetrics: for relief of pre-natal pains, in placenta previa, delayed
eclampsia, and pre-
eclampsia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
In case of acute conditions, the dosage may be repeated after an hour,
whereas the usual time
interval between the doses is 4 hours.
In case of elderly and exhausted patients, as well as in case of
concomitant use of other
sedatives, smaller doses, with gradual increase are recommended (2 –
5 mg).
Acute anxiety or agitation:
_Adults:_
5 – 10 mg i.v. or i.m. If necessary, the administration could be
repeated after 4 hours.
Delirium tremens:
_Adults: _
10 – 20 mg i.v. or i.m. If necessary, the dose of 5-10 mg should be
repeated after 4
hours.
Status epilepticus:
Diazepam Alkaloid 10 mg/2 ml solution for injection
_ _
Summary of Product Characteristics
_ _
_Adults: _
0.15 – 0.25 mg/kg body weight at a slow rate i.v. or i.m. After 30
– 60 minutes, if
necessary, the dose should be repeated or, administered in form of an
infusion that should run
at a very slow rate, drop by drop. The largest dose is 3 mg/kg body
weight d