Sodium hyaluronate (Ph. Eur.), 2.5% viscoelastic, pure and sterile preparation for intra-articular injections. ViscoPlus®Gel is a CE certified medical device that meets the requirements of the MDD 93/42/EEC directive.
According to the leaflet:
Each ready-to-use 3 ml syringe (ViscoPlus®Gel) contains:
hyaluronic acid (obtained by fermentation) sodium chloride
dihydrogen sodium phosphate
potassium dihydrogen orthophosphate
water of appropriate quality for injections
Use in the case of osteoarthritis of the synovial joints, such as the knee and hip condition.
Properties and operation:
Hyaluronic acid is a natural substance and therefore bioavailable. The most important properties of hyaluronic acid are to protect the lubrication and support the delicate tissues of the synovial joints. ViscoPlus®Gel containing sodium hyaluronate, free from bird proteins, can improve the viscoelastic properties of the synovial fluid, thereby improving the lubrication and shock-absorbing properties of the synovial fluid and reducing the mechanical load on the joints.
Usage and dosage:
ViscoPlus®Gel is injected once a week into the affected joint. The treatment should consist of at least one to two injections.
It is possible to treat several joints at the same time. If necessary, the treatment can be repeated at intervals of not less than six months. The ready-to-use syringe with the preparation should be removed from the blister pack. Remove the cap and attach the correct needle (e.g. 19 or 21 gauge) as soon as possible. Work aseptically by opening the needle and removing the syringe cap.
The preparation in the syringe is sterile. In order to protect them during storage and transport, the syringes are placed in a special sealed plastic package and additionally packed in a cardboard box. If the ready-to-use syringe with the preparation or the packaging is damaged, the syringe must not be used. When applying the drug, absolute sterility should be maintained.
Contraindications and recommended precautions:
• Do not use ViscoPlus®Gel in patients who are hypersensitive to its ingredients.
• ViscoPlus®Gel should not be applied to people suffering from inflammatory joint diseases such as rheumatoid arthritis and related diseases.
• The preparation must be applied only by qualified personnel (orthopaedists, rheumatologists and the like).
The dose must be prescribed by a doctor who will adjust it to the individual needs of the patient.
• In the event of intra-articular effusion, it is recommended to reduce the exudate by suction. ViscoPlus®Gel must be injected precisely into the joint cavity.
• Avoid application of the preparation into blood vessels and surrounding tissue.
• General precautions for intra-articular injections should be followed.
• Do not use the preparation if the package, blister or syringe is damaged.
There is limited experience with the use of hyaluronic acid in children and in women during pregnancy and lactation. Consult your doctor before using ViscoPlus®Gel in such cases.
Possible side effects:
In the area of the joint treated with ViscoPlus®Gel, local side effects such as pain, feeling hot, skin redness (erythema) and swelling may occur.
Interactions with other drugs:
Do not inject painkillers or other medications into the joint while using ViscoPlus®Gel.
The solution for injection in the syringe is sterile. For storage and transportation purposes, the syringe is protected by a cardboard box. The outer surface of the syringe is clean but not sterile. Do not use the syringe if the syringe or package is damaged. Use is required under aseptic conditions. Store at a temperature between +2 °C and +25 °C. Expiry date: it is indicated on the syringe and the packaging box
The application may only be made by a doctor.
Keep out of the reach of children!
Ready-to-use syringe (1 pc.) containing a sterile 3 ml preparation for injection (ViscoPlus®Gel)
For single use only