Natrii hialuronas Medezin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Sodium Hyaluronate Medezin(Hyaluroprol)

10 mg/ml, solution for injections

Sodium Hyaluronate
Sodium Hyaluronate Medezin and Hyaluroprol are different trade names for the same drug.

You should carefully 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Sodium Hyaluronate Medezin and what is it used for

Sodium Hyaluronate Medezin 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. The administration of Sodium Hyaluronate Medezin in degenerative joint disease leads to the normalization of such properties of synovial fluid as viscosity and elasticity, as well as the activation of cartilage repair processes. Studies have shown that hyaluronic acid has anti-inflammatory and analgesic effects, leading to improved joint mobility.
It is administered intra-articularly.
The indication for the use of Sodium Hyaluronate Medezin is degenerative joint disease of the knee with mild or moderate severity.

2. Important information before using Sodium Hyaluronate Medezin

When not to use Sodium Hyaluronate Medezin

• 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

• It is not recommended to use disinfectants containing quaternary ammonium salts, as they may cause hyaluronic acid to precipitate.
• The 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 a localized infection at the injection site, in order to avoid potential 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.
• In the event of synovial effusion, the doctor will perform joint puncture before administering the medicine.
• Before administering the medicine, the doctor will ensure 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 administering the medicine.

Other medicines and Sodium Hyaluronate Medezin

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

Driving and using machines

Sodium Hyaluronate Medezin does not affect the ability to drive and use machines.

3. How to use Sodium Hyaluronate Medezin

This medicine should always be used in accordance with the doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.
Sodium Hyaluronate Medezin 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
Remove the elastomer 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 Sodium Hyaluronate Medezin than recommended

Due to the specific dosing (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 Sodium Hyaluronate Medezin

In the event of a missed dose, 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 presented side effects come from controlled and open clinical trials, as well as 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 on its own within a few days, after simultaneous use of ice packs and unloading the joint (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 event of symptoms indicating exacerbation of a chronic inflammatory process rarely resulted in 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 side effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to: Department of 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 Sodium Hyaluronate Medezin

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
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 packaging and other information

What Sodium Hyaluronate Medezin 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 Sodium Hyaluronate Medezin looks like and what the packaging contains

Sodium Hyaluronate Medezin is a solution for injection and is available in a glass ampoule-syringe of type I glass.
Ampoule-syringe made of type I glass. Each ampoule-syringe contains 2 ml of solution.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Faran A.B.E.E.
Achaias 5 & Troizinias
145 64 Nea Kifissia
Attica
Greece

Manufacturer:

IBSA FARMACEUTICI ITALIA S.R.L.
Via Emilia 99
26900 Lodi
Italy

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Number of the marketing authorization in Greece, the country of export:
27635/16/23-03-2017
17939/10-03-2011

Number of the parallel import authorization: 326/22

Date of approval of the leaflet: 13.05.2024