Intra-articular sodium hyaluronate.

Source
The product is a sodium hyaluronate obtained by fermentation which serves to improve intra-articular viscosity and has been subjected to a steam sterilization for injectable products.

Composition
1 ml of solution contains 16 mg of sodium hyaluronate of fermentation origin, a sterile, isotonic and apyrogenic phosphate-based buffer solution, pH value 7.2, and water for injections.

Formula
1 ml contains:
Sodium hyaluronate 16,000 mg
Sodium chloride 8,500 mg
Disodium hydrogen phosphate 2H ₂ O 0.563 mg
Sodium dihydrogen phosphate 2H ₂ O 0.045 mg
Water for injections to taste

Fields of application
Pain and limitation of joint mobility in case of degenerative and traumatic changes in the knee joint and other synovial joints.

Contraindications
The product should not be used in patients:
- with a known hypersensitivity reaction to any component of the product;
- with septic arthritis;
- with skin infections or dermatological diseases at the injection site;
- being treated with anticoagulant drugs, such as Marcumar.

Warnings
Since septic arthritis is a serious side effect, please take all the usual precautions related to surgery.
The product must be injected precisely into the joint cavity; injections into blood vessels or adjacent tissues should be avoided.
Since no clinical data are available on the application of hyaluronic acid on children, pregnant women or women during breastfeeding, it is recommended not to apply the product to these categories of patients.
Do not use the product if the pre-filled syringe or sterile packaging is damaged. Observe the expiration date indicated on the box.

Possible side effects
In biocompatibility studies with the product no undesirable effects were observed.
On the treated joint, phenomena such as pain, redness and swelling could occur. These symptoms will be reduced if cold packs are applied to the treated area with an ice pack for 5 - 10 minutes.

Interactions with drugs
Up to now, no data are available regarding a possible incompatibility of the product with other solutions used at the intra-articular level. During the first few days of treatments, a simultaneous oral administration of painkillers and anti-inflammatories could be useful.
There is an incompatibility between sodium hyaluronate and quaternary ammonium compounds such as solutions containing benzalkonium chloride. For this reason it must be strictly prevented from coming into contact with surgical instruments that have been washed with these solutions or with quaternary ammonium compounds as products containing quaternary ammonium compounds as a preservative.

Administration and dosage
The syringe is pre-filled, the Luer Lock is removed and a suitable sterile sharp-tipped needle is screwed into the Luer Lock. The use of a disposable needle is recommended. If required, needles are included. Before injecting, remove any air bubbles in the syringe.
The skin is disinfected with a local antiseptic.
The product is injected into the joint once a week for 1-5 times. The beneficial effects of 1-5 sequential treatments are maintained for at least 6 months. In case of intra-articular swelling with the presence of liquid, this must be removed by aspiration before performing the injection of hyaluronic acid.
Depending on the size of the joint, 1, 3 or 5 injections of 1 ml or 2 ml can be administered intra-articularly.
The 2 ml pre-filled syringe corresponds to the appropriate volume for the knee, hip, shoulder and ankle.
Hyaluronic acid is physiologically contained in the synovial fluid. It is responsible for the viscoelastic characteristics making possible, thanks to its lubricating properties, the painless movement of the joints. It is also involved in the nutrition process of the cartilage.
Intra-articular integration with hyaluronic acid injections improves the viscoelastic characteristics of the synovial fluid. After 1-5 intra-articular injections, joint mobility is improved and pain due to degenerative lesions is relieved.

Dosage
Carton containing a 2 ml pre-filled syringe.
Needles are also supplied upon request.
Product intended for use by a physician only.

Cod. SYN-160-2ML