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INTRA-ARTICULAR SYRINGE DIART 1.8% HYALURONIC ACID 2 ML DIACO BIOFARMACEUTICI
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DIACO BIOFARMACEUTICI | SKU:
972567729
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INTRA-ARTICULAR SYRINGE DIART 1.8% HYALURONIC ACID 2 ML DIACO BIOFARMACEUTICI is backordered and will ship as soon as it is back in stock.
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Description
Description
INTRA-ARTICULAR SYRINGE DIART 1.8% HYALURONIC ACID 2 ML DIACO BIOFARMACEUTICI
DIART 1.8%
Description
Injectable medical device based on hyaluronic acid in syringe.
Hyaluronic acid is a natural polysaccharide and is an important structural element of the skin and connective tissues. Diart comes in the form of a gel and is sterile, non-pyrogenic, colorless and transparent hyaluronic acid, not of animal origin and with an optimal pH. The medical device Diart is intended to be injected into the joints in order to temporarily rebuild the viscoelasticity of the synovial fluid of the joints in the case of problems due to trauma or pathologies such as osteoarthritis.
Composition
Active ingredient: sodium hyaluronate; excipients: succinic acid, sodium succinate, sodium chloride, water for injections.
How to use
Diart should only be administered by healthcare professionals trained in intra-articular injection techniques and should only be administered into the synovial space. Before treatment, the healthcare professional should inquire about the patient's medical history and should inform the patient of the expected outcome of treatment and potential side effects.
Diart can be administered for a period of 3-5 weeks with 1-2 weeks interval between treatments, depending on the severity of the problem. Diart is supplied in 1 ml or 2 ml syringes to be used based on the size of the injection site. The recommended treatment regimen is 3 intra-articular injections per joint. The treatment regimen can be repeated after 6 months from the initial treatment, if justified by the patient's symptoms and if prescribed by the treating physician.
1) Check the expiration date specified on the package. Do not use after the expiration date.
2) Attach the label with the product data (lot number and expiration date) to the medical record of the patient who will be subjected to the treatment.
3) Open the sterile package.
4) Remove the cap from the syringe connector.
5) Connect the needle to perform the treatment, making sure it is correctly connected to the syringe.
6) Remove the needle protective cap.
7) Before proceeding with the treatment, apply light pressure to the syringe piston in order to create a drop on the tip of the needle, thus eliminating any air bubbles present in the product.
8) Provide injection and treatment.
9) After use, dispose of the product in accordance with current national regulations.
Warnings
Always use aseptic technique when using the medical device.
Do not use the device on patients with known hypersensitivity to any of the product components.
Do not use in patients who have undergone thrombolytic treatment or anticoagulant therapy in the last 2 weeks.
Do not use in patients with symptoms of viral or bacterial infections or similar.
Do not use in conjunction with disinfectants containing quaternary ammonium salts, such as benzalkonium chloride, for skin preparation.
Do not heat or cool the injection site until any redness or swelling from the primary treatment has subsided.
Do not use the product if you have infections or serious infections or skin diseases or infections in the injection area.
Do not use the product in patients under 18 years of age.
Do not use the product on pregnant or breastfeeding patients.
Adverse reactions and side effects : As with any procedure involving the use of an injectable product, this treatment may cause discomfort in some patients. Skin rashes (redness, swelling, edema, bruising, itching and slight pain at the injection site) may occur following treatment. These symptoms usually disappear within 72 hours. In rare cases, hardening and temporary loss of sensitivity may occur at the injection site. In very rare cases, necrosis, growths, granulomas, hypersensitivity and abscess formation may occur following the injection of hyaluronic acid-based products.
If any of the above applies to you, please notify your doctor and the manufacturer of the medical device immediately.
Do not administer intravenously.
Do not use if the solution is not clear and colorless.
Do not use if package is opened or damaged.
Once opened, the device must be used immediately and discarded after use.
Do not reuse: Once the product has been used for the first time, any product residue is not suitable for repeated use, since the product is no longer sterile.
Do not resterilize: Repeated sterilization may cause cross-contamination for patient and surgeon.
Do not put air into the syringe.
Do not freeze.
Heating in a microwave oven is not recommended.
The solution should not be administered orally.
The product is disposable.
After the first injection, the product is no longer sterile; do not use residues.
Before proceeding with the treatment, apply light pressure to the syringe piston in order to create a drop on the tip of the needle, thus eliminating any air bubbles present in the product.
Conservation
Store at a temperature between 5°C and 30°C (inclusive), away from direct light and heat sources, inside the properly closed package.
The expiry date refers to the product correctly stored in intact packaging.
Validity with intact packaging: 2 years.
Format
2 ml single-use pre-filled syringe containing 1.8% hyaluronic acid.
Cod. 6056
Injectable medical device based on hyaluronic acid in syringe.
Hyaluronic acid is a natural polysaccharide and is an important structural element of the skin and connective tissues. Diart comes in the form of a gel and is sterile, non-pyrogenic, colorless and transparent hyaluronic acid, not of animal origin and with an optimal pH. The medical device Diart is intended to be injected into the joints in order to temporarily rebuild the viscoelasticity of the synovial fluid of the joints in the case of problems due to trauma or pathologies such as osteoarthritis.
Composition
Active ingredient: sodium hyaluronate; excipients: succinic acid, sodium succinate, sodium chloride, water for injections.
How to use
Diart should only be administered by healthcare professionals trained in intra-articular injection techniques and should only be administered into the synovial space. Before treatment, the healthcare professional should inquire about the patient's medical history and should inform the patient of the expected outcome of treatment and potential side effects.
Diart can be administered for a period of 3-5 weeks with 1-2 weeks interval between treatments, depending on the severity of the problem. Diart is supplied in 1 ml or 2 ml syringes to be used based on the size of the injection site. The recommended treatment regimen is 3 intra-articular injections per joint. The treatment regimen can be repeated after 6 months from the initial treatment, if justified by the patient's symptoms and if prescribed by the treating physician.
1) Check the expiration date specified on the package. Do not use after the expiration date.
2) Attach the label with the product data (lot number and expiration date) to the medical record of the patient who will be subjected to the treatment.
3) Open the sterile package.
4) Remove the cap from the syringe connector.
5) Connect the needle to perform the treatment, making sure it is correctly connected to the syringe.
6) Remove the needle protective cap.
7) Before proceeding with the treatment, apply light pressure to the syringe piston in order to create a drop on the tip of the needle, thus eliminating any air bubbles present in the product.
8) Provide injection and treatment.
9) After use, dispose of the product in accordance with current national regulations.
Warnings
Always use aseptic technique when using the medical device.
Do not use the device on patients with known hypersensitivity to any of the product components.
Do not use in patients who have undergone thrombolytic treatment or anticoagulant therapy in the last 2 weeks.
Do not use in patients with symptoms of viral or bacterial infections or similar.
Do not use in conjunction with disinfectants containing quaternary ammonium salts, such as benzalkonium chloride, for skin preparation.
Do not heat or cool the injection site until any redness or swelling from the primary treatment has subsided.
Do not use the product if you have infections or serious infections or skin diseases or infections in the injection area.
Do not use the product in patients under 18 years of age.
Do not use the product on pregnant or breastfeeding patients.
Adverse reactions and side effects : As with any procedure involving the use of an injectable product, this treatment may cause discomfort in some patients. Skin rashes (redness, swelling, edema, bruising, itching and slight pain at the injection site) may occur following treatment. These symptoms usually disappear within 72 hours. In rare cases, hardening and temporary loss of sensitivity may occur at the injection site. In very rare cases, necrosis, growths, granulomas, hypersensitivity and abscess formation may occur following the injection of hyaluronic acid-based products.
If any of the above applies to you, please notify your doctor and the manufacturer of the medical device immediately.
Do not administer intravenously.
Do not use if the solution is not clear and colorless.
Do not use if package is opened or damaged.
Once opened, the device must be used immediately and discarded after use.
Do not reuse: Once the product has been used for the first time, any product residue is not suitable for repeated use, since the product is no longer sterile.
Do not resterilize: Repeated sterilization may cause cross-contamination for patient and surgeon.
Do not put air into the syringe.
Do not freeze.
Heating in a microwave oven is not recommended.
The solution should not be administered orally.
The product is disposable.
After the first injection, the product is no longer sterile; do not use residues.
Before proceeding with the treatment, apply light pressure to the syringe piston in order to create a drop on the tip of the needle, thus eliminating any air bubbles present in the product.
Conservation
Store at a temperature between 5°C and 30°C (inclusive), away from direct light and heat sources, inside the properly closed package.
The expiry date refers to the product correctly stored in intact packaging.
Validity with intact packaging: 2 years.
Format
2 ml single-use pre-filled syringe containing 1.8% hyaluronic acid.
Cod. 6056