APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
28-11-2017

Aktivna sestavina:

ramipril, Quantity: 1.25 mg

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Ramipril

Farmacevtska oblika:

Capsule

Sestava:

Excipient Ingredients: lactose monohydrate; iron oxide yellow; Gelatin; magnesium stearate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Pot uporabe:

Oral

Enote v paketu:

30

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

? Treatment of hypertension. (Data are currently not available to support the use of ramipril in renovascular hypertension).,? Post MI heart failure.,? Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day.,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke or peripheral vascular disease.,? For reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/L; HDL cholesterol < 0.9 mmol/L; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Povzetek izdelek:

Visual Identification: yellow cap & white body imprinted with APO 1.25 in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2011-09-27