SUPLASYN Solution for injection

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Περιεχόμενα

1. Name of the medicinal product

Suplasyn Sterile Sodium Hyaluronate Solution.

2. Qualitative and quantitative composition

Each syringe contains: 20mg Hyaluronic acid sodium salt. Excipients qs. 2ml. For full list of excipients see section 6.1.

3. Pharmaceutical form

2mL Syringe, containing 2mL solution for intraarticular injection.

4.1. Therapeutic indications

Suplasyn is indicated for the symptomatic treatment of osteoarthritis. Suplasyn has been shown to be beneficial in osteoarthritis for the management of pain and improvement in physical function of joints. ...

4.2. Posology and method of administration

Suplasyn is supplied as 2ml solution in a pre-filled syringe. The recommended schedule is 1 injection per week for 3 weeks, but up to 6 may be given depending on patients condition.

4.4. Special warnings and precautions for use

Warnings Do not inject intra-vascularly. The patients should rest 24-48 hours after the injection and avoid any strenuous activity over the full course of the treatment. Avoid using Suplasyn with instruments ...

4.5. Interaction with other medicinal products and other forms of interaction

Non known.

4.6. Pregnancy and lactation

As no clinical evidence is available on the use of Hyaluronic acid in children, pregnant and lactating women, treatment with Suplasyn is not recommended in theses patients.

4.8. Undesirable effects

Transient short duration pain may occur following intra-articular introduction. In some cases the effected joint may show a mild local reaction like pain, feeling of heat, hyperthermia, redness, effusion, ...

4.9. Overdose

There is no experience of overdose with Suplasyn.

5.1. Pharmacodynamic properties

By normalization of the synovial fluid quality and activation of the tissues rejuvenescence processes to the arthritic cartilage, Suplasyn improves joint function. The preparation exercises an anti-inflammatory ...

5.2. Pharmacokinetic properties

Distribution Suplasyn is detected in the synovial fluid for 2 hours and in the articular cartilage for 6 hours. The cartilage is the most firm point of the detection. The hyaluronic acid is kept in the ...

5.3. Preclinical safety data

The following preclinical studies have been completed. Subchronic (14-Day) Subcutaneous Study in Non-Swiss Mice 12 mice (6 male, 6 female) were injected subcutaneously with 25mL of Suplasyn per kg of body ...

6.1. List of excipients

Name of the substance (s) Quantity Unit Sodium chloride 8.5mg 1ml Sodium Dihydrogen Phosphate Dihydrate 0.05mg 1ml Disodium Hydrogen Phosphate Dodecahydrate 0.6mg 1ml Sodium hydroxide 0.01M ...

6.2. Incompatibilities

Avoid using Suplasyn with instruments sterilised with quaternary ammonium salts solutions.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store between 4°C and 25°C. Do not Freeze.

6.6. Special precautions for disposal and other handling

Do not inject intra-vascularly. Avoid using Suplasyn with instruments sterilised with quaternary ammonium salts solutions. For Single Use Only. Do not use if blister is damaged. To be used by physician ...

7. Marketing authorization holder

Manufacturer: Mylan Institutional, Coill Rua, Inverin, Co. Galway, Ireland Owner of the license: Mylan Pharma Group Limited, Coill Rua, Inverin, Co. Galway, Ireland

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