Descrizione Clinica
Medical devices - medical devices Diart 1.8% sir intra-art 2ml
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 is in the form of gel and is sterile hyaluronic acid, not pyrogen, colourless and transparent, 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 reconstruct the viscoelasticity of the synovial fluid of the joints in the case of problems due to traumas or pathologies such as osteoarthritis.
Composition
Active ingredient: sodium ialuronate; excipients: succinic acid, sodium succinate, sodium chloride, water for injectable preparations.
Mode of use
Diart should only be administered by health professionals trained in intra-articular injection techniques and should only be administered in the synovial space. Before treatment, it is necessary that the health care professional informs about the patient's medical history and it is necessary that the patient inform the patient of the expected outcome of the treatment and the potential side effects.
Diart can be administered for a period of 3-5 weeks with 1-2 weeks interval between one treatment and another, depending on the severity of the problem. Diart is supplied in syringes of 1 ml or 2 ml to be used based on the size of the injection site. The recommended treatment regimen is 3 intra-articorial injections for jointing. The treatment regimen can be repeated after 6 months from the initial treatment, if justified by the symptoms of the patient and if prescribed by the attending physician.
1) Check the specified expiration date on the package. Do not use after the expiry date.
2) Attach the label with the product data (lot number and expiry date) on the patient's clinical folder that will be subject to treatment.
3) Open the sterile packaging.
4) Remove the closing cap from the syringe connector.
5) Connect the needle to perform the treatment ensuring that it is correctly connected to the syringe.
6) Remove the needle protection cap.
7) Before proceeding to the treatment, make a slight pressure on the syringe piston in order to create a drop on the needle tip, thus eliminating any air bubbles present in the product.
8) Provide injection and treatment.
9) After use, eliminate the product according to the national standards in force.
Warnings
Always use an aseptic technique when using your medical device.
Do not use the device on patients with hypersensitivity note to one of the product components.
Do not use in patients who have undergone trombolitic 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 benzalconio chloride, for the preparation of the skin.
Do not heat or cool the injection point before the disappearance of redness or edema due to primary treatment.
Do not use the product in the presence of infections or severe infections or dermopathy or skin infections in the injection area.
Do not use the product in patients under 18.
Do not use the product on pregnant or breastfeeding patients.
Adverse reactions and side effects: as any procedure that provides for the use of an injectable product, this treatment could create discomfort in some patients. It is possible that skin rashes occur (red, swelling, edema, hematoma, itching and slight pain at the injection site) following treatment. Usually such symptoms regress within 72 hours. In rare cases, phenomena of hardening and loss of temporary sensitivity may occur on the injection site. In rare cases, necrosis, excrescences, granulomas, hypersensitivity and ascesse formation may occur as a result of the injection of products based on hyaluronic acid.
If you have one of the cases described above, immediately notify your doctor and the medical device manufacturer.
Do not administer intravenously.
Do not use if the solution is not transparent and colorless.
Do not use if the packaging is open or damaged.
Once opened, the device must be used immediately and deleted after use.
Do not reuse: once the product has been used for the first time, each product residue is not suitable for repeated use, since the product is no longer sterile.
Do not resterilize: a repeated sterilization could cause cross-contamination for patient and surgeon.
Do not enter air into the syringe.
Don't freeze.
Microwave oven heating is not recommended.
The solution should not be administered by mouth.
The product is disposable.
After the first injection, the product is no longer sterile; do not use residues.
Before proceeding to the treatment, make a slight pressure on 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 temperature between 5°C and 30°C (included), away from direct light and heat sources, within the properly closed packaging.
The expiration date refers to the correctly stored product in an intact packaging.
Validity of whole packaging: 2 years.
Format
2 ml disposable 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 is in the form of gel and is sterile hyaluronic acid, not pyrogen, colourless and transparent, 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 reconstruct the viscoelasticity of the synovial fluid of the joints in the case of problems due to traumas or pathologies such as osteoarthritis.
Composition
Active ingredient: sodium ialuronate; excipients: succinic acid, sodium succinate, sodium chloride, water for injectable preparations.
Mode of use
Diart should only be administered by health professionals trained in intra-articular injection techniques and should only be administered in the synovial space. Before treatment, it is necessary that the health care professional informs about the patient's medical history and it is necessary that the patient inform the patient of the expected outcome of the treatment and the potential side effects.
Diart can be administered for a period of 3-5 weeks with 1-2 weeks interval between one treatment and another, depending on the severity of the problem. Diart is supplied in syringes of 1 ml or 2 ml to be used based on the size of the injection site. The recommended treatment regimen is 3 intra-articorial injections for jointing. The treatment regimen can be repeated after 6 months from the initial treatment, if justified by the symptoms of the patient and if prescribed by the attending physician.
1) Check the specified expiration date on the package. Do not use after the expiry date.
2) Attach the label with the product data (lot number and expiry date) on the patient's clinical folder that will be subject to treatment.
3) Open the sterile packaging.
4) Remove the closing cap from the syringe connector.
5) Connect the needle to perform the treatment ensuring that it is correctly connected to the syringe.
6) Remove the needle protection cap.
7) Before proceeding to the treatment, make a slight pressure on the syringe piston in order to create a drop on the needle tip, thus eliminating any air bubbles present in the product.
8) Provide injection and treatment.
9) After use, eliminate the product according to the national standards in force.
Warnings
Always use an aseptic technique when using your medical device.
Do not use the device on patients with hypersensitivity note to one of the product components.
Do not use in patients who have undergone trombolitic 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 benzalconio chloride, for the preparation of the skin.
Do not heat or cool the injection point before the disappearance of redness or edema due to primary treatment.
Do not use the product in the presence of infections or severe infections or dermopathy or skin infections in the injection area.
Do not use the product in patients under 18.
Do not use the product on pregnant or breastfeeding patients.
Adverse reactions and side effects: as any procedure that provides for the use of an injectable product, this treatment could create discomfort in some patients. It is possible that skin rashes occur (red, swelling, edema, hematoma, itching and slight pain at the injection site) following treatment. Usually such symptoms regress within 72 hours. In rare cases, phenomena of hardening and loss of temporary sensitivity may occur on the injection site. In rare cases, necrosis, excrescences, granulomas, hypersensitivity and ascesse formation may occur as a result of the injection of products based on hyaluronic acid.
If you have one of the cases described above, immediately notify your doctor and the medical device manufacturer.
Do not administer intravenously.
Do not use if the solution is not transparent and colorless.
Do not use if the packaging is open or damaged.
Once opened, the device must be used immediately and deleted after use.
Do not reuse: once the product has been used for the first time, each product residue is not suitable for repeated use, since the product is no longer sterile.
Do not resterilize: a repeated sterilization could cause cross-contamination for patient and surgeon.
Do not enter air into the syringe.
Don't freeze.
Microwave oven heating is not recommended.
The solution should not be administered by mouth.
The product is disposable.
After the first injection, the product is no longer sterile; do not use residues.
Before proceeding to the treatment, make a slight pressure on 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 temperature between 5°C and 30°C (included), away from direct light and heat sources, within the properly closed packaging.
The expiration date refers to the correctly stored product in an intact packaging.
Validity of whole packaging: 2 years.
Format
2 ml disposable pre-filled syringe containing 1.8% hyaluronic acid.
Cod. 6056
