Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
GLUCOSAMINE SULFATE, SODIUM CHLORIDE
Rottapharm S.p.A Galleria Unione, 5-20122 Milan, Italy
M01AX05
GLUCOSAMINE SULFATE 250 mg SODIUM CHLORIDE 64 mg
HARD CAPSULE
GLUCOSAMINE SULFATE 250 mg SODIUM CHLORIDE 64 mg
POM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
Withdrawn
2007-03-02
_AF121006AF09 _ VIARTRIL ® -S _GLUCOSAMINE SULFATE _ COMPOSITION Each capsule contains: _ACTIVE INGREDIENT _ Crystalline glucosamine sulfate 314.0 mg _ _ _equivalent to: glucosamine sulfate _ _250.0 mg _ _ _ _sodium _ _chloride _ _64.0 mg _ _EXCIPIENTS _ Maize starch, Lactose, Magnesium stearate, Talc. _Shell of the hard-gelatine capsule _ Titanium dioxide (E 171), Iron oxides (E 172), Erythrosine (E 127), Gelatin. PHARMACEUTICAL FORM AND PRESENTATION Package of 80 capsules of 250 mg. PHARMACO-THERAPEUTIC GROUP _M01AX05_: Other antiinflammatory/antirheumatic, non steroidal drugs – _Glucosamine sulfate_. MARKETING AUTHORIZATION HOLDER AND MANUFACTURER _Marketing Authorisation Holder_: ROTTAPHARM – S.p.A. - Galleria Unione 5 - 20122 Milan - Italy. _Manufacturer responsible for batch release_: ROTTAPHARM Ltd. - Damastown Industrial Park, Mulhuddart, Dublin 15 - Ireland or ROTTAPHARM S.p.A. - Via Valosa di Sopra 9 - 20052 Monza (MI) – Italy. THERAPEUTIC INDICATIONS Relief of symptoms in mild to moderate osteoarthritis. CONTRA-INDICATIONS Assessed individual hypersensitivity to glucosamine. PRECAUTIONS FOR USE The administration of VIARTRIL ® -S should be withdrawn in women with fertility problems or in women who are undergoing fertility tests. The use of VIARTRIL ® -S is not advised in women who intend to have pregnancy. No unfavourable effects on the reproductive functions or on lactation are known. Nevertheless, the use of the product should be limited to cases of acknowledged necessity and under medical control. - 2 - INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION The oral administration of glucosamine sulfate can enhance the gastrointestinal absorption of tetracyclines and decrease that of penicillines or chloramphenicol contemporaneously administered by oral route. Steroidal or non-stero Đọc toàn bộ tài liệu
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT VIARTRIL-S 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard-gelatin capsule contains: _ACTIVE INGREDIENT_: Crystalline glucosamine sulfate 314.0 mg _ equivalent _ _to: _ _glucosamine _ _sulfate _ _250.0 _ _mg _ _ _ _ _ _sodium chloride _ _64.0 mg _ 3. PHARMACEUTICAL FORM Hard-gelatine capsules. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Relief of symptoms in mild to moderate osteoarthritis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION If not differently prescribed by the physician, 2 hard-gelatin capsules three times daily (in the morning and at meals) are recommended for 6 weeks or more if necessary. The therapeutic cycle can be repeated at 2-month intervals. 4.3. CONTRAINDICATIONS Assessed individual hypersensitivity to glucosamine. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Although VIARTRIL-S has not an inhibitory activity on the synthesis of prostaglandins and cycloxygenase, its use is not advised in women who intend to have pregnancy. The administration of VIARTRIL®-S should be withdrawn in women with fertility problems or in women who are undergoing fertility tests. 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The oral administration of glucosamine sulfate can enhance the gastrointestinal absorption of tetracyclines and decrease that of penicillines or chloramphenicol contemporaneously administered by oral route. Steroidal or non-steroidal analgesic or antiinflammatory agents can be administered contemporaneously. 4.6. PREGNANCY AND LACTATION Page 2 of 5 The animal studies did not evidence any unfavourable effects on the reproductive functions or on lactation. Nevertheless, the use of the drug should be limited to ca Đọc toàn bộ tài liệu