Descrizione Clinica
Medical devices - medical devices Donegal has 2.0 sir 40mg 2ml3pz Donegal
Donegal HA 2.0
Description
Medical device with CE mark complies with Directive MDD 93/42/EEC, containing 20 mg/ml of hyaluronic acid obtained by fermentation and not chemically modified. Donegal HA 2.0 is a transparent, sterile, apirogenous and viscoelastic solution provided in a 2 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, especially in the synovial liquid, and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber. According to many studies the injections of hyaluronic acid in joints with osteoarthritis restore the viscosity and elasticity of the synovial fluid, resulting in pain attenuation and an improvement in the mobility of the joint. Donegal HA 2.0 acts only at the level of the joint in which it is injected, without exercising any systemic action.
Mode of use
Remove any joint deposit before injecting Donegal HA 2.0, for removal of the effusion and injection of Donegal HA 2.0 must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with opening. Securely screw the diameter needle between 18 and 22 G to the Luer type locking collar to ensure a stagnant seal. Before injection treat the site with an appropriate antiseptic solution. Inject Donegal HA 2.0 by adopting a septic technique. Inject only in the joint cavity.
Administration: Donegal HA 2.0 must be administered weekly for a total of 3 weeks or in any case according to the prescription.
Components
Main component: hyaluronic acid salt sodium 2.0%. Other components: sodium chloride, sodium phosphate and water for injectable preparations (q.b.).
Warnings
The content of the pre-filled syringe is sterile. The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile. Do not use Donegal HA 2.0 after the expiration date shown on the package. Do not use Donegal HA 2.0 if the packaging or syringe is open or damaged. The injection point must be on healthy skin. Don't inject vascularly. Do not inject outside the joint cavity, tissues or synovial capsules. Donegal HA 2.0 was not tested in pregnant women or breastfeeding. Donegal HA 2.0 is disposable and should not be resterilized. Avoid the simultaneous administration of Donegal HA 2.0 with other intra-articular products to prevent any interaction. Do not administer DONEGAL HA 2.0 in the presence of abundant intra-articular deposit. Once the packaging is opened, DONEGAL HA 2.0 must be used immediately and eliminated after use according to current rules. Keep away from the reach of children. As with every invasive treatment of jointing, it is recommended for the patient to avoid all intense physical activity for the first 2-3 days after injection.
Contraindications: Donegal HA 2.0 should not be given to patients with proven sensitivity to hyaluronic acid and its compounds; in case of infection or skin disease near the injection site; if the joint is infected or strongly inflamed.
Side effects: Transitional side reactions may occur as a result of Donegal HA 2.0 injection, such as pain, stiffness, feeling of heat, redness or swelling. These secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. As in any invasive treatment of jointing, a septic arthritis may occur if the appropriate precautions during injection or injection point are not observed.
Intra-articular injection must be carried out exclusively by a doctor or in accordance with local legislation.
Conservation
Store in the original packaging at a temperature between 0 and 25°C, sheltered from direct sunlight and frost. The expiry date is indicated on the packaging.
Format
available in packs of 1 and 3 syringes. Each glass syringe contains 40 mg of hyaluronic acid in 2 ml of buffered physiological solution of sodium chloride, packaged in a blister. The content of the syringe is sterilized with wet heat.
Cod. 0100000146
Medical device with CE mark complies with Directive MDD 93/42/EEC, containing 20 mg/ml of hyaluronic acid obtained by fermentation and not chemically modified. Donegal HA 2.0 is a transparent, sterile, apirogenous and viscoelastic solution provided in a 2 ml syringe. Hyaluronic acid is a natural polysaccharide present in many human tissues, especially in the synovial liquid, and acts in the joints both as a lubricant of cartilage and ligaments and as a shock absorber. According to many studies the injections of hyaluronic acid in joints with osteoarthritis restore the viscosity and elasticity of the synovial fluid, resulting in pain attenuation and an improvement in the mobility of the joint. Donegal HA 2.0 acts only at the level of the joint in which it is injected, without exercising any systemic action.
Mode of use
Remove any joint deposit before injecting Donegal HA 2.0, for removal of the effusion and injection of Donegal HA 2.0 must be used the same needle. Remove the protective syringe cap paying special attention to avoid contact with opening. Securely screw the diameter needle between 18 and 22 G to the Luer type locking collar to ensure a stagnant seal. Before injection treat the site with an appropriate antiseptic solution. Inject Donegal HA 2.0 by adopting a septic technique. Inject only in the joint cavity.
Administration: Donegal HA 2.0 must be administered weekly for a total of 3 weeks or in any case according to the prescription.
Components
Main component: hyaluronic acid salt sodium 2.0%. Other components: sodium chloride, sodium phosphate and water for injectable preparations (q.b.).
Warnings
The content of the pre-filled syringe is sterile. The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile. Do not use Donegal HA 2.0 after the expiration date shown on the package. Do not use Donegal HA 2.0 if the packaging or syringe is open or damaged. The injection point must be on healthy skin. Don't inject vascularly. Do not inject outside the joint cavity, tissues or synovial capsules. Donegal HA 2.0 was not tested in pregnant women or breastfeeding. Donegal HA 2.0 is disposable and should not be resterilized. Avoid the simultaneous administration of Donegal HA 2.0 with other intra-articular products to prevent any interaction. Do not administer DONEGAL HA 2.0 in the presence of abundant intra-articular deposit. Once the packaging is opened, DONEGAL HA 2.0 must be used immediately and eliminated after use according to current rules. Keep away from the reach of children. As with every invasive treatment of jointing, it is recommended for the patient to avoid all intense physical activity for the first 2-3 days after injection.
Contraindications: Donegal HA 2.0 should not be given to patients with proven sensitivity to hyaluronic acid and its compounds; in case of infection or skin disease near the injection site; if the joint is infected or strongly inflamed.
Side effects: Transitional side reactions may occur as a result of Donegal HA 2.0 injection, such as pain, stiffness, feeling of heat, redness or swelling. These secondary manifestations can be alleviated with the application of ice on the treated joint. They usually disappear after a short time. If symptoms persist, contact a doctor. As in any invasive treatment of jointing, a septic arthritis may occur if the appropriate precautions during injection or injection point are not observed.
Intra-articular injection must be carried out exclusively by a doctor or in accordance with local legislation.
Conservation
Store in the original packaging at a temperature between 0 and 25°C, sheltered from direct sunlight and frost. The expiry date is indicated on the packaging.
Format
available in packs of 1 and 3 syringes. Each glass syringe contains 40 mg of hyaluronic acid in 2 ml of buffered physiological solution of sodium chloride, packaged in a blister. The content of the syringe is sterilized with wet heat.
Cod. 0100000146
