Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
HYALURONATE SODIUM
Fidia Farmaceutici S.p.A.
M09AX01
HYALURONATE SODIUM
20mg/2ml Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
hyaluronic acid
Marketed
1999-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hyalgan solution for intra-articular injection, 20 mg/2 ml, prefilled syringe. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 20 mg/2 ml of Sodium hyaluronate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for intra-articular injection. Clear, viscous solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the sustained relief of pain in osteoarthritis of the knee. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS (INCLUDING THE ELDERLY) The contents of one pre-filled syringe (20 mg/2mL) to be injected into the affected joint once a week to a total of five injections, using a standard technique. No adjustment of dose is required in elderly patients. This can be repeated at not less than 6 monthly intervals. CHILDREN At present there is not enough evidence to recommend a dosage regimen for use in children. Intra-articular injection of Hyalgan should be made using precise, anatomical localisation into the joint cavity of the knee to be treated. The injection site in the knee is determined by that location which is easier to reach. Usually a lateral approach can be followed, but in some cases a medial approach is preferable. Strict aseptic precautions should be observed during the administration in order to avoid the possibility of developing infections in the injection site. The solution in the pre-filled syringe is ready for use and requires only a sterile disposable needle. To ensure sterility the injection site must be carefully cleansed with antiseptic. Care should be taken to expel any trapped air bubbles from the syringe containing Hyalgan prior to administration. Joint effusion, if present, should be aspirated by arthrocentesis prior to injection of Hyalgan. The arthrocentesis should be made using a 20 gauge needle and the joint should be aspirated to almost dryness, but not to degree that would compromise the accuracy of the subsequent Hyalgan injection. An appropriate exami Lestu allt skjalið