CREVASTIN 15 Milligram Film Coated Tablet
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
17-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
ROSUVASTATIN (AS CALCIUM)
थमां उपलब्ध:
Clonmel Healthcare Ltd
INN (इंटरनेशनल नाम):
ROSUVASTATIN (AS CALCIUM)
डोज़:
15 Milligram
फार्मास्यूटिकल फॉर्म:
Film Coated Tablet
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may be renewed (B)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2014-03-27
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crevastin 15 mg film coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg rosuvastatin (as rosuvastatin calcium).
Excipients with known effect: each film-coated tablet contains 86.0 mg lactose monohydrate and 0.12 mg soybean
lecithin.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets, debossed with “R9UN 15” on one side and on the other side scored.
The score line is not intended for breaking the tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type IIa), excluding
heterozygous familial hypercholesterolaemia) or with mixed dyslipidaemia (type IIb) as an adjunct to diet when
response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL
apheresis) or if such treatments are not appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular
event (see Section 5.1), as an adjunct to correction of other risk factors.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue
during treatment. The dose should be individualised according to the goal of therapy and patient response, using current
consensus guidelines.
Rosuvastatin may be given at any time of the day, with or without food.
TREATMENT OF HYPERCHOLE
पूरा दस्तावेज़ पढ़ें
