Țară: Singapore
Limbă: engleză
Sursă: HSA (Health Sciences Authority)
Ezetimibe
GLENMARK PHARMACEUTICALS SINGAPORE PTE. LTD.
C10AX09
TABLET
Ezetimibe 10 mg
ORAL
Prescription Only
Glenmark Pharmaceuticals Limited
ACTIVE
2022-02-18
For the use only of a Registered Medical Practitioners or a Hospital or a Laboratory SAME SIZE ARTWORK LEAFLET SIZE : 115 mm x 560 mm 50 mm 35 mm SPACE FOR PHARMACODE Ezetimibe Tablets 10 mg PE00000 SG Manufactured by: B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai - 400 026, (India). At: Plot No. 2, Phase II, Pharma Zone, Indore Special Economic Zone, Pithampur, Dist. Dhar (M.P), Pincode - 454775. PRODUCT REGISTRANT: Glenmark Pharmaceuticals Singapore Pte Ltd 6 Shenton Way, OUE Downtown #38-01 Singapore 068809 TABLET 10 MG SAME SIZE ARTWORK LEAFLET SIZE : 115 mm x 560 mm 35 mm PE00000 SG QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablet contains: Ezetimibe10 mg PHARMACEUTICAL FORM Tablet White to off-white, capsule shaped, flat, beveled edged uncoated tablets engraved with glenmark logo 'G' on one side and'44'on the other side. CLINICAL PARTICULARS _PRIMARY HYPERCHOLESTEROLAEMIA_ Ezetimibe, administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol ( total- C), low- density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non- familial) hypercholesterolemia. Ezetimibe, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia. _HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_ Ezetimibe, administered with atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid lowering treatments (eg. LDL apheresis) or if such treatments are unavailable. _HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_ Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. POSOLOGY AND METHOD OF ADMINISTRATION The patient sh Citiți documentul complet