Hialgan

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Hyalgan

10 mg/ml (20 mg/2 ml), solution for injection
Sodium hyaluronate

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should 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 administration.
The indication for the use of Hyalgan is osteoarthritis of the knee joint of mild or moderate severity.

2. Important information before using Hyalgan

When not to use Hyalgan

• if the patient is allergic (hypersensitive) 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

• It is not recommended to use disinfectants containing quaternary ammonium salts, 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 administer the medicine with particular caution 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 should consider the advisability of administering the medicine.
• If the presence of 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 into 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

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as about 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 physico-chemical incompatibilities have been observed with medicines such as corticosteroids, administered in intra-articular injections.

Pregnancy and breastfeeding

In pregnancy and breastfeeding or if you think you may be pregnant or are planning to become pregnant, you should 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 cases where it is absolutely necessary. The doctor will decide, based on the assessment of the risk-to-benefit ratio, 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 as directed by your doctor. If you are unsure, consult 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 remains
Syringe: remove the rubber cap 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 screw the needle on too tightly, 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, you should contact your doctor to determine the date of the next injection. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects presented come from controlled and open clinical trials and from 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.
Discomfort at the injection site was transient and resolved spontaneously within a few days, after simultaneous use of ice packs and unloading of the joint (rest recommended).
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 resulted in worsening of the disease course.
Hypersensitivity reactions and anaphylactic reactions (known from spontaneous reports) resolved without permanent consequences.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 provide more information on the safety of the medicine.

5. How to store Hyalgan

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze. Store the syringe in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should 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.
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 syringe made of colorless glass type I.
The syringe contains 2 ml of the solution, is closed with a bromobutyl rubber cap and a Luer-Lock adapter, and is placed in a blister pack, in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, in the country of export:

Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (Padua)
Italy

Manufacturer:

Fidia Farmaceutici S.p.A.
Via Ponte della Fabbrica 3/A
35031 Abano Terme (Padua)
Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, in the country of export:LT/1/03/3349/002
Parallel import authorization number:310/18

Date of approval of the leaflet: 29.08.2023

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