|Solatum™ Intra-articular Joint Injection||Week 1||Week 2||Week 3||Week 4|
* Depending on the severity of degenerative change
Indication: Indicated for the symptoms of osteoarthritis of the knee. By replacing and supplementing the pathological synovial fluid in the osteoarthritic joints, it reduces pain and improves joint function. When injected into joint cavities can help with lubrication and buffering of damaged cartilage, suppression of inflammation and stimulation of production of high molecular weight hyaluronic acid (hyaluronate), which can help with joint pain, increasing mobility, decreasing synovitis and delaying disease progression.
Contraindication: Not suitable for the following patient groups:
Description: Hyaluronic acid (HA) is a critical substance in synovial fluid present in healthy joints, which acts as a shock absorber. A loss of hyaluronic acid associated with conditions such osteoarthritis or as a result of injury, causes symptoms such as joint pain and stiffness. Solatum™ HA Intra–articular Joint Injection Gel when injected into joint cavities can help with lubrication and buffering of damaged cartilage, suppression of inflammation, stimulation of production of high molecular HA sodium which can help with joint pain, increasing mobility, decreasing synovitis and delaying disease progression. The active substance is a highly purified sodium salt of hyaluronic acid.
Contents: Each Solatum™ HA Intra–articular Joint Injection prefilled syringe contains sodium hyaluronate in a phosphate buffered saline for a single intra-articular injection. The following volumes and concentration of HA are available: 2.0ml and 2.5ml, each of 10mg/ml and 12mg/ml. Note: Solatum™ HA Intra–articular Joint Injection is supplied without a needle to allow the physician or healthcare professional to choose the most appropriate gauge for the injection.
Directions for Use: Clean the skin around the injection site with antiseptic and allow to dry before giving injection. If joint effusion is present it should be aspirated before injection of HA. Discard the syringe and needle after single use. A suggested dosage regimen is injection into the affected joint space once a week for up to four injections depending on the severity of degenerative change to the knee joint. Alternatively, ad hoc injections may be given. The therapeutic effect of Solatum™ HA Intra–articular Joint Injection Gel may last for up to three months. Transient pain and a feeling of heat may occur with intra-articular injections. These will disappear spontaneously in 2 to 3 days. If there is no improvement, then stop using and use appropriate symptomatic treatment.
Storage Conditions: Store between 2°C and 25°C in a well ventilated and clean area with relative humidity below 80%. Do not freeze. Protect from light. Poor storage conditions will affect the products performance or could lead to product contamination.
Disposal: Dispose after use in a sharps bin or appropriate container.
Date of Preparation: June 2019
|Sodium hyaluronate||20 mg/mL|
|NaH2 PO4||0.14 mg/mL|
|Water for injection||q.s. to weight|
Primary ingredients and performance: Solatum is a clear gel solution, obtained by dissolving sodium hyaluronate or hyaluronic acid (hereinafter as ‘HA’) in phosphate buffered saline, which is contained in a pre-filled syringe. Solatum is for a single intra-articular injection. The product is a unique type of linear macromolecular mucopolysaccharide, composing repeating disaccharide units of glucuronic acid and N-acetyl glucosamine. Its chemical formula is (C14H21NO11)n. It is supplied in the concentration of HA at 20 mg/mL. Solatum, is of non-animal origin, with the advantages of high viscoelasticity, lubricity, physical alterability and good biocompatibility. It is a medical polymer extracted and refined by high-tech bio-engineering from streptococcal fermentation metabolites. It is sterile and free from pyrogenicity, allergy, genetic toxicity, or skin irritation. Due to fermentation production of HA, the product has no risk of being a virus carrier. This product can be used as an orthopaedic agent to improve the joint function. When used in joint cavities, due to its macromolecular characteristics and good viscoelasticity, it stimulates synovium to produce high molecular sodium hyaluronate, which is beneficial for relieving joint pain, increasing mobility, decreasing synovitis and delaying disease progression.
Indications: Solatum is indicated for the treatment of symptoms of osteoarthritis of the knee. By replacing and supplementing the pathological synovial fluid in the osteoarthritic joints, it reduces pain and improves joint function.
Instructions for use:
A. To attach needle to syringe
B. Physician instructions
The dosage regimen is injecting into the affected synovial joint space with only one injection.
Adverse reactions: Mild transient local pain, swelling, arthralgia and joint stiffness at the injections site have been reported after intra-articular injections. These symptoms are generally mild and transient. They usually resolve within 2 to 7 days without medical intervention. If symptoms are persistent, please consult with your doctor.
Notes: The container for medical sodium hyaluronate is composed of glass. Please use carefully. Do not use after expiry date printed on the package. The expiry date refers to the product stored in its original packaging at the temperature between 2oC - 20oC. Keep out of reach of children. The safety and effectiveness of Solatum has not been tested on paediatric patients, pregnant or lactating women.
Storage: Store between 2oC and 20oC, do not freeze. Relative humidity shall be no more than 80%. Store in a clean, well ventilated condition, and avoid corrosive gas. Protect from light.
Shelf life: 2 years.
Specifications: 20 mg/ml : 3.0 ml (60 mg/3ml).
Effective Date: June 2019.