HYALGAN 20MG/2ML SODIUM HYALURONATE 1 PREFILLED SYRINGE

1. WHATIS HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Other drugs for musculoskeletal disorders.
This drug is recommended in painful osteoarthritis of the knee, with effusion.
Its effect is delayed: the reduction in pain is maximal 2 to 3 months after the first injection.

2. WHAT YOU SHOULD KNOW BEFORE USING HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe

Never use HYALGAN 20 mg/2 ml, solution for injection for intra-articular use in pre-filled syringe in the following cases

• allergy (hypersensitivity) to sodium hyaluronate or to substances with a similar activity or to any of the other components contained in this medicine, mentioned in section 6,
• anti-coagulant treatment (risk of haematoma),
• children under 16 years of age.

In case of doubt, it is essential to ask your doctor or pharmacist for advice.

Warnings and precautions
Be careful with HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe:

• if you are pregnant or breastfeeding, tell your doctor.

In case of doubt, do not hesitate to ask your doctor or pharmacist for advice.

Other medicines and HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Pregnancy and breastfeeding
Pregnancy
The use of this medicine is not recommended during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor promptly: only he/she will be able to adapt the treatment to your condition.
Ask your doctor or pharmacist for advice before taking any medicine
Breastfeeding
As a precautionary measure, this medicine should not be used if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

3. HOW TO USE HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe

Dosage
Injections should only be carried out by an experienced physician and should be done in a strictly aseptic manner. It is important to aspirate before injecting to ensure that the needle tip is not in a vessel. The recommended dose is 1 intra-articular infiltration of 20 mg/2 ml per week for up to 5 weeks.
If you feel that the effect of HYALGAN 20 mg/2 ml, Intra-articular Solution for Injection in a pre-filled syringe is not what you expected, consult your doctor or pharmacist

Method of administration
Intra-articular use only. For adults only.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. WHAT ARE THE SIDE EFFECTSOF THIS MEDICATION?
Like all medicines, this medicine can cause side effects, but they do not always occur in everyone.
These are mainly local pain, fever, allergy.

Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres -
By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.

5. HOW TO STORE HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringes
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the pack. The expiry date refers to the last day of that month.
Store in its outer packaging, protected from light and at a temperature not exceeding 25°C.
Do not freeze.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe, contains

• The active substance is :

Sodium hyaluronate (Hyalectin): 20.0 mg, for a 2 ml pre-filled syringe.

• The other components are:

Sodium chloride, disodium phosphate dodecahydrate, monosodium phosphate dihydrate, water for injection.

What is HYALGAN 20 mg/2 ml, solution for intra-articular injection in pre-filled syringe and what does it contain?
This medicine comes in a 2 ml pre-filled syringe. Box of 1.

Marketing authorisation holder
FIDIA FARMACEUTICI S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme
ITALY