Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Posology and Method of Administration –** **Adults (including the elderly)** The contents of one vial (20mg/2ml) or prefilled syringe (20mg/2ml) to be injected into the affected joint once a week for 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
Medical Information
**Therapeutic Indications –** Treatment / sustained relief of pain in osteoarthritis of the knee.
**Contra-indications –** Hyalectin®, the active principle in Hyalgan®, is of avian origin. Do not administer to patients with known hypersensitivity to any ingredient of the product or to avian proteins. Intra-articular injections are contra-indicated in cases of infections or skin diseases in the area of the injection site.
S01KA01
hyaluronic acid
Manufacturer Information
PHARMAFORTE SINGAPORE PTE LTD
FIDIA FARMACEUTICI S.P.A
Active Ingredients
Documents
Package Inserts
Hyalgan Injection PI.pdf
Approved: May 24, 2019