VALIUM

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

DIAZEPAM

Tersedia dari:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Internasional):

DIAZEPAM

Dosis:

5.0 MG

Bentuk farmasi:

INJEKSI

Unit dalam paket:

DUS, 5 AMPUL @ 2 ML

Diproduksi oleh:

CENEXI SAS - France

Tanggal Otorisasi:

2020-03-25

Karakteristik produk

_Draft_Valium_PI_safety-update_CDS9.0_EN_v4_
_ _
_Page 1 of 16_
INFORMATION FOR HEALTH PROFESSIONALS
VALIUM
®
Diazepam
1.
DESCRIPTION
1.1 THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Tranquilizer and anxiolytic.
ATC code: N05BA01.
1.2 TYPE OF DOSAGE FORM
Ampoules.
1.3 ROUTE OF ADMINISTRATION
-
Intravenous injection
-
Intramuscular injection
1.4 STERILE/RADIOACTIVE STATEMENT
Sterile product.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ diazepam.
Ampoules 10 mg in 2 mL.
Valium ampoules contain benzyl alcohol. For warning related to benzyl
alcohol (see _ 2.4.1 _
_Warnings and Precautions, General_).
2.
CLINICAL
PARTICULARS
2.1 THERAPEUTIC INDICATION(S)
The injection form of Valium is indicated for basal sedation before
proceeding with major
therapeutic interventions, such as cardioversion, cardiac
catheterization, endoscopy, radiological
procedures, minor surgical interventions, in order to relieve
apprehension, anxiety, acute stress
and to diminish recollections of such procedures.
The injection form is also suitable for premedication of patients
suffering from anxiety and stress.
Excitation: In psychiatry, Valium is used in the treatment of
excitation states associated with
acute anxiety and panic, as well as in motor unrest and delirium
tremens.
Valium is indicated to treat status epilepticus and other convulsive
states (including tetanus).
Valium is useful for the relief of reflex muscle spasm due to local
trauma (injury, inflammation).
It
can
also
be
used
to
combat
spasticity
arising
from
damage
to
spinal
and
supraspinal
interneurons e.g. cerebral palsy and paraplegia, as well as in
athetosis and “stiff-man” syndrome.
DISETUJUI OLEH BPOM : 10/03/2021
EREG10036411900296
_Draft_Valium_PI_safety-update_CDS9.0_EN_v4_
_ _
_Page 2 of 16_
2.2 DOSAGE AND ADMINISTRATION
_ _
_GENERAL _
For optimal effect, the dosage should be carefully individualized.
While the usual daily dosages
given below will meet the needs of most patients, there will be some
who may require higher
doses.
For adults and adolesc