Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
HYALURONIC ACID
Fidia Farmaceutici S.p.A Via Ponte della Fabbrica 3/A, 35031 Abano Terme, Padova, Italy
M09AX01
HYALURONIC ACID 10 mg/ml
SOLUTION FOR INJECTION
HYALURONIC ACID 10 mg/ml
POM
OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
Withdrawn
2006-11-28
Page 1 of 4 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT HYALGAN® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 Each pre-filled syringe contains: 20 mg/2ml of hyaluronic acid sodium salt (Hyalectin ®) See section 6.1 for details of excipients 3. PHARMACEUTICAL FORM Hyalgan is a sterile solution for intra-articular injection for single use only. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Traumatic and degenerative joint disease. Adjuvant in orthopaedic surgery. 4.2. Posology and method of administration 2 ml of Hyalgan (20mg) administered intra-articularly once a week for 5 weeks or as directed by the physician. Treatment may be repeated, usually, at 6 up to 12-month intervals. 4.3. Contra-indications Individual hypersensitivity to any of its components. Hyalgan cannot be used in patients who are allergic to avian proteins, feathers, and eggs products. 4.4. Special warnings and special precautions for use It is necessary to follow a correct technique of intra-articular injection in accurately aseptic conditions. See also item 6.6. Particular attention must be paid in case of patients with an infection close to the injection path, in order to avoid the possibility of developing bacterial arthritis. Remove joint effusion, if present, before injecting Hyalgan. Patients should be carefully examined prior to administration to determine signs of acute inflammation and the physician should evaluate whether Hyalgan treatment should be initiated when objective signs of inflammation are present. A healthcare professional must instruct the patient to rest for 48 hours following the administration of the product, doing as little exercise as possible and avoiding standing for long periods of time. Subsequently, they may gra সম্পূর্ণ নথি পড়ুন