Curavisc®
Sodium hyaluronate E.P.
1.0% viscoelastic solution
Sterile solution for intra-articular injection
Composition:
1 prefilled syringe with 2 ml (Curavisc®) injection solution contains: 20 mg (Curavisc®) sodium hyaluronate (obtained by fermentation) as well as sodium chloride, sodium monohydrogen phosphate, sodium dihydrogen phosphate, and water for injection.
Indications:
Pain and functional impairment in degenerative and traumatic damage of synovial joints.
Curavisc® can be used in large joints such as knee, hip, and shoulder joints, as well as in small joints such as facet joints of the spine, thumb saddle joint, interphalangeal joints of fingers and toes, big toe metatarsophalangeal joint, and temporomandibular joint.
Contraindications and precautions:
Patients with confirmed hypersensitivity to components of the injection solution must not be given the product.
Special caution is required in patients with confirmed hypersensitivity to medications.
Curavisc® contains as an active ingredient highly pure sodium hyaluronate obtained by fermentation. In rare individual cases, allergic reactions to neutral protein fractions cannot be excluded.
The general precautions for intra-articular injections must be observed. Curavisc® must be injected precisely into the joint cavity. Injections into blood vessels and surrounding tissue must be avoided.
Since no clinical experience is available for the use of hyaluronate in children, during pregnancy and breastfeeding, or in inflammatory joint diseases such as rheumatoid arthritis or ankylosing spondylitis, treatment with Curavisc® is not recommended in these cases.
If joint effusion is present, it is recommended to reduce it by aspiration, rest, and application of an ice pack. Corticosteroid injections may also be considered if necessary. Treatment with Curavisc® can be started two to three days later.
Side effects:
Local symptoms such as pain, warmth, skin redness (flush), and swelling may occur in a joint treated with Curavisc®. Applying an ice pack to the treated joint for five to ten minutes reduces the occurrence of these symptoms.
Interactions with other products:
Currently, there is no information on interactions and incompatibilities of Curavisc® with other solutions for intra-articular use.
Concomitant administration of an oral analgesic or anti-inflammatory drug during the first days of treatment may further improve symptoms.
Dosage and administration:
Curavisc® is injected once weekly into the affected joint, at least three and at most five times. Multiple joints can be treated simultaneously. Depending on the severity of joint damage, the beneficial effect of a treatment cycle of five intra-articular injections can last for months. The efficacy of a single treatment cycle of fewer than three injections has not been proven. Repeat treatments can be administered as needed at intervals of no less than six months.
Remove the prefilled syringe from the blister pack. Remove the cap and immediately attach a needle appropriate for the size of the joint (e.g., 19 or 21 G). Remove any air bubbles from the syringe before injection.
Please note:
The injection solution in the syringe is sterile. For protection during storage and transport, the prefilled syringe is packed in a blister pack and a carton. The outer surface of the prefilled syringe is clean but not sterile.
If the prefilled syringe or blister pack is damaged, the syringe must not be used.
Aseptic technique must be strictly observed during administration.
Properties and mode of action:
The hyaluronate responsible for the viscoelasticity of joint fluid (synovial fluid) is present in the synovial fluid of all joints, especially in large weight-bearing joints, where the synovial fluid ensures normal pain-free movement through its lubricating and shock-absorbing properties. Additionally, the synovial fluid is responsible for the nutrient supply of the cartilage.
In degenerative joint disorders, e.g., osteoarthritis, the viscoelasticity of the synovial fluid is significantly reduced, diminishing its lubricating and shock-absorbing functions. Due to increased mechanical stress on the joint, cartilage destruction increases, leading to pain and restricted mobility of the affected joint. Supplementing the synovial fluid by intra-articular administration of Curavisc®, which contains bird protein-free sodium hyaluronate of high purity, can improve the viscoelastic properties of the synovial fluid.
In this way, the lubricating and shock-absorbing properties of the synovial fluid are improved, and mechanical overload of the joints is reduced. Usually, after a treatment cycle of five intra-articular injections, pain relief and improved mobility lasting up to six months can be achieved.
Package size:
1 prefilled syringe with 2 ml (Curavisc®) sterile injection solution
Storage instructions:
Store between +2 °C and +25 °C. Do not use the product after the expiration date!
For use by a physician only.
Keep out of reach of children!
Manufacturer:
curasan AG
Lindigstraße 4
63801 Kleinostheim
Germany
Information status:
01/2021
Joint injections
Dermafiller
Supplements
