Cavstat

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Rosuvastatin calcium 5.198 mg equivalent to rosuvastatin 5 mg;  
Available from:
Mylan New Zealand Ltd
INN (International Name):
Rosuvastatin calcium 5.198 mg (equivalent to rosuvastatin 5 mg)
Dosage:
5 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Rosuvastatin calcium 5.198 mg 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 indications:
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.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/Polyamide/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, laminate layer (polyamide/aluminium/LDPE dessicant-HDPE)/aluminium foil - 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 number:
TT50-9269
Authorization date:
2013-04-03

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