SUPLASYN® / SUPLASYN® 1-Shot
Sterile Sodium Hyaluronate Solution
Hyaluronic acid is a common component of synovial fluid and plays a central role in maintaining the physiological environment of the joint.
Composition
Viscoelastic solution of purified hyaluronic acid with a defined molecular weight, produced by fermentation.
One prefilled syringe contains:
|
SUPLASYN |
SUPLASYN 1-Shot |
| Sodium hyaluronate |
20 mg |
60 mg |
| Isotonic, buffered aqueous solution |
2 ml |
6 ml |
Properties
Hyaluronic acid is the prototype of a large group of polysaccharides (glycosaminoglycans) that are important components of all extracellular tissue structures, including cartilage and synovial fluid. The active ingredient of SUPLASYN is a hyaluronic acid of defined molecular chain length with a high degree of purity. Injection of SUPLASYN into the joint space helps normalize joint function after joint puncture.
Indications
SUPLASYN and SUPLASYN 1-Shot are indicated for the symptomatic treatment of osteoarthritis. SUPLASYN has a therapeutic effect in treating pain and improving joint function in osteoarthritis. Multiple joints can be treated simultaneously.
Dosage and Method of Administration
Depending on the size of the joint, up to 6 ml is injected intra-articularly.
SUPLASYN: The usual treatment with SUPLASYN in 2 ml syringes consists of 3 injections at weekly intervals; up to 6 injections can be administered depending on the severity of the condition.
SUPLASYN 1-Shot: For single use only.
Aseptic conditions must be strictly observed. Any remaining hyaluronic acid in the prefilled syringes must be discarded. To use the prefilled syringe, remove the “Luer-lock cap,” attach a suitable needle (21-25 G recommended depending on the size of the joint), and secure it by gently twisting. The graduations on the syringe label are for orientation purposes only.
Contraindications/Precautions
Do not use in patients with known hypersensitivity to the ingredients of SUPLASYN. General precautions and contraindications for intra-articular injections must be observed. Do not inject intravascularly. SUPLASYN should only be used in joints free of inflammation/irritation, as adverse reactions are more common in patients with existing joint inflammation/irritation.
There are no clinical data on the use of hyaluronic acid in children, pregnant, or breastfeeding women. Therefore, SUPLASYN should not be used in these patient groups.
After injection of SUPLASYN, the treated joint should be rested for 24-48 hours. Physically strenuous activities should be avoided throughout the treatment period with SUPLASYN.
Temporary, short-lasting pain may occur after joint injection as a result of the injection itself. Mild local reactions such as pain, warmth, overheating, redness, effusion, irritation, and swelling/inflammation may occur in the area of the affected joint. If such symptoms occur, it is recommended to rest the affected joint and apply ice. In most patients, these symptoms resolve within a few days.
In rare cases, as a sign of hypersensitivity, mild local reactions such as pain, irritation, swelling/joint inflammation, and effusion may be more pronounced and severe. In these cases, therapeutic intervention such as joint puncture may be necessary. Local adverse reactions may be accompanied by systemic reactions such as fever, chills, or circulatory reactions, and in rare cases, anaphylactic reactions may occur.
In extremely rare cases, rash/itching, hives (urticaria), inflammation of the joint lining (synovitis), and a drop in blood pressure have been observed after injection of SUPLASYN. Administration should be discontinued if adverse reactions occur. Do not use SUPLASYN with instruments sterilized in quaternary ammonium salt solutions.
Warnings
Keep out of reach of children. Do not use if the blister packaging is damaged. For use by physicians only. For single use only. Any remaining contents in the syringe must be discarded. Reuse carries the risk of contamination and/or infection or cross-infection of patients.
Package Sizes
Package containing 1 prefilled syringe of 2 ml or 6 ml.
Storage Instructions
Store packages between 4 °C and 25 °C. Protect from frost.
Warm to room temperature before injection.
Date of Information Preparation
February 2010
Information Status
First edition
Manufacturer
Bioniche Teo.
Inverin, Co. Galway, Ireland.
© Bioniche Pharma Group Limited, Ireland
+49 (0)9306 904463
CE 0473
Joint injections
Dermafiller
Supplements
