Hyalgan

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Hyalgan
10 mg/ml (20 mg/2 ml), solution for injection
Natrii hyaluronas
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm another person, even if their symptoms appear identical.
• If any of the adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Hyalgan is and what it is 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 Hyalgan is and what it is used for

Hyalgan contains the active substance – highly purified hyaluronic acid, i.e. a high-molecular-weight compound belonging to 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. Exogenous administration of Hyalgan in joint degenerative disease leads to normalization of synovial fluid properties such as viscosity and elasticity, and stimulates reparative processes in articular cartilage. Studies have shown that hyaluronic acid exerts anti-inflammatory and analgesic effects, resulting in improved joint mobility.
Intra-articular use.
The indication for Hyalgan is mild to moderate osteoarthritis of the knee joints.

2. Important information before using Hyalgan

When not to use Hyalgan

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

Warnings and precautions

• Disinfectants containing quaternary ammonium salts should not be used, as hyaluronic acid may precipitate in their presence.
• Intra-articular injection of the medicine should be performed by a properly trained physician, using appropriate technique and under aseptic conditions required for this route of administration.
• The physician will administer the medicine with particular caution in patients with an infection localized in the area of the injection site to avoid possible development of bacterial arthritis.
• Before performing intra-articular injection, the physician will thoroughly examine the patient to rule out acute joint inflammation. If such a diagnosis is established, the physician should consider whether administration of the medicine is justified.
• In case joint effusion is detected, the physician will perform joint puncture before injecting the medicine.
• Before injecting the medicine, the physician will ensure that the needle has not been inserted into a blood vessel (do not aspirate into the syringe containing the medicine).
• It is recommended to avoid overloading 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 using or have recently used, as well as any medicines you plan to use.
Hyaluronic acid, when used concomitantly with certain locally acting anesthetics, prolongs the duration of anesthesia.
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
During pregnancy and breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a 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 if clearly necessary. The decision will be made by the physician based on an assessment of the benefit-risk ratio.

Driving and operating machinery
Hyalgan has no influence on the ability to drive vehicles or operate machinery.

3. How to use Hyalgan

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Hyalgan is administered as intra-articular injections once a week at a dose of 20 mg
(2 ml) for 5 weeks, under aseptic conditions.
Instructions for preparing the medicine for use and disposal of any residue
Pre-filled syringe: remove the elastomeric stopper and carefully screw the needle onto the syringe, taking care not to press the plunger. Check that the needle is securely attached to the threaded connector.
Do not overtighten the needle, as this may cause the connector to twist off.
Any unused product and waste material should be disposed of in accordance with local regulations.
Use of a higher than recommended dose of Hyalgan
Due to the specific mode of administration (intra-articular injections are performed exclusively by a physician), overdose by the patient is not possible.
Missed dose of Hyalgan
If a dose is missed, contact your doctor to schedule the next injection. Do not administer a double dose to make up for the missed dose.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everybody experiences them.
The adverse reactions listed below originate from controlled and open clinical trials as well as from spontaneous reports after marketing authorization.

Uncommon adverse reactions (occur in 1 to 10 people in 10,000):
pain, effusion, swelling, increased local warmth, redness, arthritis, post-procedural conditions at the site of local administration, i.e. any other complications following joint puncture.

Very rare adverse reactions (occur in less than 1 person in 10,000) and adverse reactions with unknown frequency (cannot be estimated from the available data):
synovitis, septic arthritis, hypersensitivity reactions, anaphylaxis, rash, urticaria, pruritus.

Reactions at the injection site were transient in nature and resolved spontaneously within a few days, especially with concomitant application of cold compresses and joint unloading (recommended rest).

The above adverse reactions very rarely had a more severe course and persisted longer.

Administration of hyaluronic acid injections in cases with symptoms indicating an exacerbation of chronic inflammatory process rarely led to worsening of the disease.

Hypersensitivity and anaphylactic reactions (known from spontaneous reports) resolved without permanent consequences.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hyalgan

Keep this medicine out of the sight and reach of children.
Store below 25°C. Do not freeze. Keep the ampoule-syringe in the outer packaging to protect 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Hyalgan contains
The active substance is sodium hyaluronate.
1 ml of injection solution contains the active substance: 10 mg sodium hyaluronate.
The other ingredients are: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections.

What Hyalgan looks like and contents of the pack
Hyalgan is a solution for injection and is available in a pre-filled syringe made of colourless type I glass.
The pre-filled syringe contains 2 ml of solution, closed with a bromobutyl rubber stopper and Luer-Lock adapter, and is placed in a blister pack within a cardboard box.
For further information, please contact the responsible party or the parallel importer.

Responsible party in Lithuania, 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
Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Lithuania, the country of export: LT/1/03/3349/002
Parallel Import Licence Number: 310/18