Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIAZEPAM
BOEHRINGER INGELHEIM INDONESIA - Indonesia
DIAZEPAM
5 MG/ML
CAIRAN INJEKSI
DUS, 5 AMPUL @ 2 ML
CENEXI SAS - France
2015-04-08
_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 Baca dokumen lengkapnya