Land: Indonesien
Språk: indonesiska
Källa: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
IPRATROPIUM BROMIDE MONOHYDRATE; SALBUTAMOL SULFATE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
IPRATROPIUM BROMIDE MONOHYDRATE; SALBUTAMOL SULFATE
2,5/0,5 MG PER 2,5 ML
CAIRAN INHALER
DUS, 20 VIAL @ 2,5 ML
BOEHRINGER INGELHEIM - West Germany
2015-11-20
PT. BOEHRINGER INGELHEIM INDONESIA 1. Medical & Drug Regulatory Affairs Red : COMBIVENT UDV 0204-07, Green : change position No. 0204-07 11 April 2019 COMBIVENT ® UNIT DOSE VIALS IPRATROPIUM BROMIDE SALBUTAMOL SULPHATE COMPOSITION 1 unit-dose vial (2.5 mL) solution for inhalation contains: Ipratropium bromide corresponding to 0.5 mg ipratropium bromide anhydrous 0.52 mg Salbutamol sulphate corresponding to 2.5 mg salbutamol base 3.01 mg Excipients: sodium chloride, hydrochloric acid, purified water INDICATIONS COMBIVENT UDV is indicated for the management of reversible bronchospasm associated with obstructive pulmonary diseases and acute asthma attack in patients who require more than a single bronchodilator. DOSAGE AND ADMINISTRATION COMBIVENT ® has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations. Patients should be advised to consult a physician or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea if additional inhalations of COMBIVENT ® do not produce an adequate improvement. If higher than recommended doses of COMBIVENT ® are required to control symptoms, the patient's therapy plan should be reviewed. The following doses of COMBIVENT ® are recommended for adults (including elderly patients): COMBIVENT ® solution for inhalation in unit dose vials COMBIVENT inhalation solution in unit dose vials may be administered from a suitable nebuliser or an intermittent positive pressure ventilator. Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician. The treatment with the nebuliser solution in UDVs should always be started with the lowest recommended dose (1 UDV). In very severe cases Läs hela dokumentet