Cavstat

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5 mg;  

MAH:

Viatris Limited

INN:

Rosuvastatin calcium 5.198 mg (equivalent to rosuvastatin 5 mg)

dosage:

5 mg

pharmaceutical_form:

Film coated tablet

composition:

Active: Rosuvastatin calcium 5.198mg equivalent to rosuvastatin 5 mg   Excipient: Colloidal silicon dioxide Crospovidone Iron oxide red Lactose monohydrate Light magnesium oxide Magnesium stearate Microcrystalline cellulose Opadry Yellow

units_in_package:

Blister pack, laminate layer (polyamide/aluminium/LDPE dessicant-HDPE)/aluminium foil, 30 tablets

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Assia Chemical Industries Ltd

therapeutic_indication:

Rosuvastatin calcium is indicated to: · Reduce elevated LDL-C, total cholesterol, triglycerides and to increase HDLcholesterol in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidaemia (Fredrickson Types IIa and IIb). Rosuvastatin calcium also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL-C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increase Apo-A-I in these populations. · Treat isolated hypertriglyceridaemia (Fredrickson Type IV hyperlipidaemia). · Reduce total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or alone if such treatments are unavailable.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, PVC/Aclar/Al, PVC/Polyamide/Al or polyamide/Al/LDPE dessicant-HDPE)/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white bottle/PP screw closure - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE white bottle/PP screw closure - 500 tablets - 24 months from date of manufacture stored at or below 25°C

authorization_date:

2013-04-03