Apaurin solution for i/v and i/m injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diazepam

Available from:

KRKA d.d.

ATC code:

N05BA01

INN (International Name):

diazepam

Dosage:

5mg/ml

Pharmaceutical form:

solution for i/v and i/m injection

Units in package:

(10/2x5/) ampoules 2ml, in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-05-23

Patient Information leaflet

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Summary of Product characteristics

PI_Text007931_1
– Updated:
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apaurin solution for i. v. and i.m. injection 5 mg/ ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 ml of solution (1 ampoule) contains 10 mg diazepam.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection: clear, slightly yellow or greenish yellow, s
olution with a smell of ethanol,
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANXIETY
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual
to extreme distress.
For the parenteral route, Apaurin is indicated for the treatment of
moderate to severe cases of agitation,
anxiety and tension.
As a pre-operative drug it is indicated for basal sedation in anxious
or tense patients, induction of
anaesthesia
and
sedation
prior
to
diagnostic,
surgical
and
endoscopic
procedures
(cardiac
catheterisation).
ALCOHOL WITHDRAWAL
In patients
with alcohol
withdrawal
it can be used for relieving
excitation, panic, tremor and
hallucinations (delirium tremens).
ANTICONVULSANT THERAPY
Acute treatment of status epilepticus, severe convulsions, tetanus and
preeclampsia or eclampsia. In
this case possible risk for the fetus as compared to the therapeutic
benefit for the mother should be
considered.
MUSCLE SPASM
It
is
a
good
adjunctive
drug
in
the
treatment
of
muscle
spasms
due
to
local
trauma
(lesion,
inflammation). It can also be used to combat spasticity caused by the
diseases of spinal and supraspinal
interneurons, such as cerebral palsy and paraplegia, as well as
athetosis and generalized muscular
rigidity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Apaurin injections can be administered intravenously or
intramuscularrly. Dosage should be adjusted
individually, depending on the severity of symptoms, age and condition
of the patient. In acute
conditions, the dose may be repeated after 1 hour but the usual dosing
interval is 4 hours. Lower doses
CONFIDENTIAL
Apaurin 5 mg