Hialgan

Package Leaflet: Information for the Patient

HYALGAN

Sodium Hyaluronate
10 mg/ml, solution for injection

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, or if any side effects get worse, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Hyalgan and what is it used for
• 2. Important information before using Hyalgan
• 3. How to use Hyalgan
• 4. Possible side effects
• 5. How to store Hyalgan
• 6. Contents of the pack and other information

1. What is Hyalgan and what is it used for

Hyalgan contains the active substance – highly purified hyaluronic acid, i.e. a high molecular weight compound from the group of glycosaminoglycans (polysaccharide acids), which is an important component of all extracellular structures. This compound occurs physiologically in high concentrations, among others, in cartilage and synovial fluid. Intra-articular administration of Hyalgan in osteoarthritis leads to normalization of such properties of synovial fluid as viscosity and elasticity, and to activation of cartilage repair processes. Studies have shown that hyaluronic acid has anti-inflammatory and analgesic effects, leading to improved joint mobility. Intra-articular use. The indication for the use of Hyalgan is osteoarthritis of the knee joints of mild or moderate severity.

2. Important information before using Hyalgan

When not to use Hyalgan

• If the patient is hypersensitive (allergic) to hyaluronic acid or any of the other ingredients of the medicine (listed in section 6);
• if the patient has ever had an allergy to avian protein;
• if the patient has severe liver failure.

Warnings and precautions

• Disinfectants containing quaternary ammonium salts should not be used, as they may cause precipitation of hyaluronic acid.
• Intra-articular injection of the medicine should be performed by a properly trained doctor, in accordance with the appropriate technique and under aseptic conditions required for this route of administration.
• The doctor will be particularly careful when administering the medicine to patients with localized infection in the area of the injection site, in order to avoid potential development of bacterial arthritis.
• Before performing the intra-articular injection, the doctor will carefully examine the patient to rule out acute arthritis. If such a diagnosis is made, the doctor will consider the appropriateness of administering the medicine.
• If joint effusion is found, the doctor will perform joint puncture before injecting the medicine.
• Before injecting the medicine, the doctor will make sure that the needle has not been inserted into a vessel (do not aspirate the syringe with the medicine).
• It is recommended not to overload the joint for several hours after administration of the medicine.

Other medicines and Hyalgan

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Hyaluronic acid used simultaneously with some locally acting anesthetics prolongs the anesthesia period. Disinfectants containing quaternary ammonium salts may cause precipitation of hyaluronic acid. No physicochemical incompatibilities have been observed with medicines such as corticosteroids administered in intra-articular injections.

Pregnancy and breastfeeding

In pregnancy and breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult your doctor or pharmacist before using this medicine. Animal studies have not shown embryotoxic or teratogenic effects of hyaluronic acid; however, in pregnant and breastfeeding women, Hyalgan should be used only in absolutely necessary cases. The doctor will decide on the basis of the risk-benefit assessment whether to use the medicine.

Driving and using machines

Hyalgan does not affect the ability to drive and use machines.

3. How to use Hyalgan

This medicine should always be used in accordance with the doctor's recommendations. If you have any doubts, ask your doctor or pharmacist. Hyalgan is administered in the form of intra-articular injections once a week in a dose of 20 mg (2 ml) for 5 weeks, under aseptic conditions. Instructions for preparing the medicine for use and disposing of its remainsVial: remove the plastic cap and rubber stopper and draw the contents of the vial into the syringe. Prefilled syringe: remove the rubber stopper and carefully screw the needle onto the syringe so as not to press the plunger. Check that the needle is properly seated in the threaded connector. Do not overtighten the needle, as this may cause the connector to twist. Unused product and its remains should be disposed of in accordance with applicable regulations.

Using a higher dose of Hyalgan than recommended

Due to the specific dosing regimen (intra-articular injections are performed exclusively by a doctor), it is not possible for the patient to overdose on the medicine.

Missing a dose of Hyalgan

If a dose of the medicine is missed, contact your doctor to determine the date of the next injection. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The presented side effects come from controlled and open clinical trials and spontaneous reports after the medicine was placed on the market. Rare side effects (occurring in 1 to 10 people out of 10,000): pain, effusion, swelling, increased local warming, redness, arthritis, conditions after local use, i.e. any other complications after joint puncture. Very rare side effects (occurring in less than 1 person out of 10,000) and frequency not known (cannot be determined based on available data): synovitis, infectious arthritis, hypersensitivity reactions, anaphylaxis, rash, urticaria, itching. Local reactions at the injection site were transient and resolved spontaneously within a few days, with concurrent use of ice packs and joint unloading (recommended rest). The above side effects only very rarely had a more severe course and lasted longer. The use of hyaluronic acid injections in the presence of symptoms indicating exacerbation of chronic inflammatory process rarely caused worsening of the disease. Hypersensitivity reactions and anaphylactic reactions (known from spontaneous reports) resolved without permanent consequences.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, Tel. +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Hyalgan

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the carton and on the vial and prefilled syringe after the abbreviation EXP. The expiry date refers to the last day of the given month. The batch number of the medicine on the vial and prefilled syringe is stated after the abbreviation Lot. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hyalgan contains

• The active substance of the medicine is sodium hyaluronate. 1 ml of the solution for injection contains the active substance: 10 mg of sodium hyaluronate (Hyalectin)
• The medicine also contains: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

What Hyalgan looks like and what the pack contains

Hyalgan is a solution for injection and is available in a vial or prefilled syringe made of type I glass. The vial contains 2 ml of the solution, is closed with a rubber stopper (latex-free) with an aluminum ring and a plastic cap, and is placed in a blister pack in a cardboard box. The prefilled syringe contains 2 ml of the solution, is closed with a rubber stopper (latex-free) and a threaded connector of the Luer-Lock type, and is placed in a blister pack in a cardboard box. Marketing Authorization Holder and Manufacturer:Fidia Farmaceutici S.p.A. Via Ponte della Fabbrica, 3/A 35031 Abano Terme (Padua), Italy. email: [email protected]

Date of last revision of the leaflet: