Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
ZOFENOPRIL CALCIUM
A. MENARINI SINGAPORE PTE. LTD.
C09AA15
30 mg
TABLET, FILM COATED
ZOFENOPRIL CALCIUM 30 mg
ORAL
Prescription Only
A MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL
ACTIVE
2004-02-10
BIFRIL ® Zofenopril calcium 30 mg COMPOSITION Each BIFRIL 30 mg coated tablet contains: ACTIVE INGREDIENT: Zofenopril calcium 30 mg EXCIPIENTS: CORE: microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silica. COAT: hydroxypropylmethyl cellulose (hypromellose), titanium dioxide (E171), macrogol 400, macrogol 6000. INDICATIONS HYPERTENSION BIFRIL is indicated for the treatment of mild to moderate essential hypertension. ACUTE MYOCARDIAL INFARCTION BIFRIL is indicated for the treatment initiated within the first 24 hours of patients with acute myocardial infarction with or without signs and symptoms of heart failure, who are haemo- dynamically stable and have not received thrombolytic therapy. CONTRAINDICATIONS • Hypersensitivity to zofenopril calcium or any other ACE inhibitor. • History of angioneurotic oedema associated with previous ACE inhibitor therapy. • Hereditary/idiopathic angioneurotic oedema. • Severe hepatic impairment. • Pregnancy. • Lactation period. • Women of child-bearing potential unless protected by effective contraception. • Bilateral renal artery stenoses or unilateral renal artery stenosis in cases of a solitary single kidney. PRECAUTIONS HYPOTENSION: As with other ACE inhibitors, BIFRIL may cause a profound fall in blood pressure especially after the first dose.Symptomatic hypotension is rare in uncomplicated hypertensive patients. It is more likely to occur in patients who have been volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting. It has been reported mainly in patients with severe heart failure with or without associated renal insufficiency. This is more likely in patients on high doses of loop diuretics, or those with hyponatraemia or functional renal impairmen Perskaitykite visą dokumentą
BIFRIL® Zofenopril calcium 30 mg COMPOSITION Each BIFRIL 30 mg coated tablet contains: ACTIVE INGREDIENT: Zofenopril calcium 30 mg EXCIPIENTS: CORE: microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silica. COAT: hydroxypropylmethyl cellulose (hypromellose), titanium dioxide (E171), macrogol 400, macrogol 6000. INDICATIONS HYPERTENSION BIFRIL is indicated for the treatment of mild to moderate essential hypertension. ACUTE MYOCARDIAL INFARCTION BIFRIL is indicated for the treatment initiated within the first 24 hours of patients with acute myocardial infarction with or without signs and symptoms of heart failure, who are haemodynamically stable and have not received thrombolytic therapy. CONTRAINDICATIONS • Hypersensitivity to zofenopril calcium or any other ACE inhibitor. • History of angioneurotic oedema associated with previous ACE inhibitor therapy. • Hereditary/idiopathic angioneurotic oedema. • Severe hepatic impairment. • Pregnancy. • Lactation period. • Women of child-bearing potential unless protected by effective contraception. • Bilateral renal artery stenoses or unilateral renal artery stenosis in cases of a solitary single kidney. • The concomitant use of BIFRIL with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m 2 ) (see Interactions). PRECAUTIONS HYPOTENSION: As with other ACE inhibitors, BIFRIL may cause a profound fall in blood pressure especially after the first dose. Symptomatic hypotension is rare in uncomplicated hypertensive patients. It is more likely to occur in patients who have been volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting. It has been reported mainly in patients with severe heart failure with or without associated renal insufficiency. This is more likely in patients on high doses of loop diuretics, or those with hyponatraemia or functional renal impairment. In these patients treatment Perskaitykite visą dokumentą