Valium

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

diazepam

Disponible desde:

Roche Farma S.A

Designación común internacional (DCI):

diazepam

Dosis:

5mg

formulario farmacéutico:

tablets

tipo de receta:

Prescription

Información para el usuario

VALIUM
®
Diazepam
COMPOSITION
_Active ingredient_
: diazepam.
_Excipients_
_Valium Tablets, 5 mg:_
lactose monohydrate, maize starch, iron oxide yellow,
magnesium stearate.
_Valium Tablets, 10 mg: _
lactose monohydrate, maize starch, indigotine,
magnesium stearate.
_Valium Ampoules, 10 mg/2 ml:_
preservative: 95 mg sodium benzoate
(E211); 5 mg benzoic acid (E210); benzyl alcohol, propylene glycol;
ethyl
alcohol; 2 ml water for injections.
PHARMACEUTICAL FORM AND AMOUNT OF
ACTIVE INGREDIENT PER UNIT
_Valium Tablets, 5 mg:_
yellow scored
TABLETS
containing 5 mg diazepam.
_Valium Tablets, 10 mg:_
light-blue scored
TABLETS
containing 10 mg
diazepam.
_Valium Ampoules, 10 mg/2 ml:_
clear
INJECTION SOLUTION
containing
10 mg
diazepam per 2 ml.
INDICATIONS AND POTENTIAL USES
ORAL DOSAGE FORMS
Symptomatic treatment of anxiety, agitation, and tension resulting
from
psychoneurotic conditions and temporary situational disturbances. As
an
adjuvant in the treatment of mental and organic disorders with an
anxiety
component. Anxiety can manifest itself as an obviously anxious mood,
as
worried behavior, and/or via functional autonomic or motor symptoms
(palpitations, sweating, sleep disturbance, tremor, nervous
restlessness, etc.).
PARENTERAL DOSAGE FORM
Basic sedation prior to stressful therapeutic measures or procedures
such as
endoscopy, cardioversion, cardiac catheterization, radiological
investigations, minor surgery, reduction of dislocations and
fractures,
biopsies, dressing changes in burns patients, etc. in order to
alleviate
anxiety or acute stress reactions and to aid post-procedure amnesia.
Preoperative medication in anxious and tense patients.
_Indications in psychiatry_
Treatment of agitation associated with acute anxiety states and panic
attacks, motor restlessness and delirium tremens.
_Anticonvulsant action_
Treatment of status epilepticus and other convulsive states
(including tetanus).
_Gynecology/obstetrics_
Treatment of eclampsia, if magnesium sulphate is contraindicated,
ineffective or unavailable.
ALL DOSAG

Ficha técnica

November 2015
Summary of Product Characteristics
Ro 05-2807
Valium ampoules, tablets
November 2015
VALIUM
®
Diazepam
COMPOSITION
_Active ingredient_: diazepam.
_Excipients_
_Valium Tablets, 5 mg:_ lactose monohydrate, maize starch, iron oxide
yellow, magnesium
stearate.
_Valium _
_Tablets, _
_10 mg: _
lactose
monohydrate,
maize
starch,
indigotine,
magnesium
stearate.
_Valium _
_Ampoules, _
_10 mg/2 ml:_
preservative:
95 mg
sodium
benzoate
(E211);
5 mg
benzoic acid (E210); benzyl alcohol, propylene glycol; ethyl alcohol;
2 ml water for
injections.
PHARMACEUTICAL FORM AND AMOUNT OF ACTIVE
INGREDIENT PER UNIT
_Valium Tablets, 5 mg:_
yellow scored TABLETS containing 5 mg diazepam._ _
_Valium Tablets, 10 mg:_
light-blue scored TABLETS containing 10 mg diazepam.
_Valium Ampoules, 10 mg/2 ml:_ clear INJECTION SOLUTION containing 10
mg diazepam per
2 ml._ _
INDICATIONS AND POTENTIAL USES
ORAL DOSAGE FORMS
Symptomatic treatment of anxiety, agitation, and tension resulting
from psychoneurotic
conditions and temporary situational disturbances. As an adjuvant in
the treatment of
mental and organic disorders with an anxiety component. Anxiety can
manifest itself as an
obviously anxious mood, as worried behavior, and/or via functional
autonomic or motor
symptoms (palpitations, sweating, sleep disturbance, tremor, nervous
restlessness, etc.).
PARENTERAL DOSAGE FORM
Basic sedation prior to stressful therapeutic measures or procedures
such as endoscopy,
cardioversion,
cardiac
catheterization,
radiological
investigations,
minor
surgery,
reduction of dislocations and fractures, biopsies, dressing changes in
burns patients, etc. in
order to alleviate anxiety or acute stress reactions and to aid
post-procedure amnesia.
Preoperative medication in anxious and tense patients.
_Indications in psychiatry _
November 2015
Summary of Product Characteristics
Ro 05-2807
Valium ampoules, tablets
November 2015
Treatment of agitation associated with acute anxiety states and panic
attacks, motor
restlessness and delirium tremens.
_Anticonvulsant