SCAD
SINOVIAL 50 siringa intra-art 2%
⚕️ SALE RESERVED FOR HEALTHCARE PROFESSIONALS
Following the recent clarification issued by the Italian Ministry of Health on the distribution and sale of Class III medical devices and injectable fillers, this product may only be sold to qualified healthcare professionals (physicians or other authorised healthcare practitioners).
Do not proceed with the purchase unless you meet the requirements: non-compliant orders will be cancelled and fully refunded.
Are you a healthcare professional? Download the declaration, fill it in and sign it, then send it together with a valid ID document to care@dermadea.com, quoting your order number. Your order will then be processed within the usual timeframe.
Synovial fluid substitute that helps restore the physiological and rheological properties of arthritic joints. This therapeutic action is explained by the specific characteristics of the hyaluronic acid used. The hyaluronic acid contained in SINOVIAL 50 2.5 ml, obtained through fermentation and not chemically modified, has excellent tolerability. By restoring the viscoelastic properties of synovial fluid, SINOVIAL 50 2.5 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 50 2.5 ml acts only at the site where it is injected, without exerting any systemic action. Improvement is immediate: already after the first injection, the global WOMAC index decreases, and from the third injection, the decrease becomes statistically significant.
Indicated in cases of acute and chronic tendinopathies and/or associated with joint disability and in the tendon repair process, even following surgical interventions. SINOVIAL 50 2.5 ml is a medical device designed to supplement synovial fluid, allowing the restoration of the physiological and rheological properties of arthritic joints and tendons. In the joint, SINOVIAL 50 2.5 ml reduces pain and promotes the recovery of associated joint and tendon mobility, acting only in the synovial cavity where it is injected, without exerting any systemic action. Additionally, due to its lubricating and viscoelastic characteristics, it acts at the level of the tendon sheath, improving tendon gliding and the physiological processes of healing/repair, thus preventing the formation of adhesions in postoperative courses.
Instructions for use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the cap of the syringe, firmly holding the "Luer Lock" closure collar between your fingers and being particularly careful to avoid contact with the opening. Insert the needle into the Luer Lock closure collar of the syringe (needle diameter between 18 and 22G) by screwing it tightly until you feel slight pressure to ensure a tight seal and prevent fluid leakage during administration, while firmly holding the "Luer Lock" closure collar between your fingers.
Inject SINOVIAL 50 2.5 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peri-tendinous area, depending on the identified medical necessity.
Components
2% hyaluronic acid, highly purified sodium salt (molecular weight between 800 and 1,200 KDalton), sodium chloride, sodium phosphate, water for injectable preparations.
Warnings
SINOVIAL 50 2.5 ml can only be injected by a physician.
The contents of the pre-filled syringe are sterile.
The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use after the expiration date indicated on the package.
Do not use if the packaging is opened or damaged.
The injection site must be on healthy skin.
Do not inject intravenously. Do not inject outside the joint cavity, into the synovial tissue, or into the joint capsule. Do not administer in the presence of abundant intra-articular effusion.
Do not re-sterilize. The device is intended for single use only. Do not reuse to avoid any risk of contamination.
Once opened, it must be used immediately and disposed of after use.
Keep out of reach and sight of children.
After intra-articular injection or into the tendon synovium, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days.
The possible presence of an air bubble does not compromise the characteristics of the product.
Do not mix SINOVIAL 50 2.5 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Extra-articular infiltration of SINOVIAL 50 2.5 ml may cause local undesirable effects. During the use of SINOVIAL 50 2.5 ml, symptoms such as pain, warmth, redness, or swelling may occur at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. Normally, they disappear after a short time. The physician must ensure that patients inform them of any adverse effects occurring after treatment.
SINOVIAL 50 2.5 ml should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the injection site area.
The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.
To date, no interactions between SINOVIAL 50 2.5 ml and other drugs are known.
Do not mix with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
It should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the injection site area. The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.
SINOVIAL 50 2.5 ml can only be injected by a physician.
Storage
Store at room temperature and below 25 °C, away from heat sources. Do not freeze.
Validity of unopened packaging: 36 months.
Format
Package containing 1 pre-filled syringe (50.0 mg of sodium hyaluronate in 2.5 ml of buffered saline solution) and 1 needle 21G x 1 ½" (0.8 x 40 mm).
SINOVIAL 50 siringa intra-art 2%
⚕️ SALE RESERVED FOR HEALTHCARE PROFESSIONALS
Following the recent clarification issued by the Italian Ministry of Health on the distribution and sale of Class III medical devices and injectable fillers, this product may only be sold to qualified healthcare professionals (physicians or other authorised healthcare practitioners).
Do not proceed with the purchase unless you meet the requirements: non-compliant orders will be cancelled and fully refunded.
Are you a healthcare professional? Download the declaration, fill it in and sign it, then send it together with a valid ID document to care@dermadea.com, quoting your order number. Your order will then be processed within the usual timeframe.
Synovial fluid substitute that helps restore the physiological and rheological properties of arthritic joints. This therapeutic action is explained by the specific characteristics of the hyaluronic acid used. The hyaluronic acid contained in SINOVIAL 50 2.5 ml, obtained through fermentation and not chemically modified, has excellent tolerability. By restoring the viscoelastic properties of synovial fluid, SINOVIAL 50 2.5 ml reduces pain and restores joint and tendon mobility.
SINOVIAL 50 2.5 ml acts only at the site where it is injected, without exerting any systemic action. Improvement is immediate: already after the first injection, the global WOMAC index decreases, and from the third injection, the decrease becomes statistically significant.
Indicated in cases of acute and chronic tendinopathies and/or associated with joint disability and in the tendon repair process, even following surgical interventions. SINOVIAL 50 2.5 ml is a medical device designed to supplement synovial fluid, allowing the restoration of the physiological and rheological properties of arthritic joints and tendons. In the joint, SINOVIAL 50 2.5 ml reduces pain and promotes the recovery of associated joint and tendon mobility, acting only in the synovial cavity where it is injected, without exerting any systemic action. Additionally, due to its lubricating and viscoelastic characteristics, it acts at the level of the tendon sheath, improving tendon gliding and the physiological processes of healing/repair, thus preventing the formation of adhesions in postoperative courses.
Instructions for use
Aspirate any joint effusion before proceeding with the injection.
Carefully unscrew the cap of the syringe, firmly holding the "Luer Lock" closure collar between your fingers and being particularly careful to avoid contact with the opening. Insert the needle into the Luer Lock closure collar of the syringe (needle diameter between 18 and 22G) by screwing it tightly until you feel slight pressure to ensure a tight seal and prevent fluid leakage during administration, while firmly holding the "Luer Lock" closure collar between your fingers.
Inject SINOVIAL 50 2.5 ml at room temperature and under strict aseptic conditions, into the synovial space of the joint or into the tendon sheath/peri-tendinous area, depending on the identified medical necessity.
Components
2% hyaluronic acid, highly purified sodium salt (molecular weight between 800 and 1,200 KDalton), sodium chloride, sodium phosphate, water for injectable preparations.
Warnings
SINOVIAL 50 2.5 ml can only be injected by a physician.
The contents of the pre-filled syringe are sterile.
The syringe is packaged in a sealed blister. The outer surface of the syringe is not sterile.
Do not use after the expiration date indicated on the package.
Do not use if the packaging is opened or damaged.
The injection site must be on healthy skin.
Do not inject intravenously. Do not inject outside the joint cavity, into the synovial tissue, or into the joint capsule. Do not administer in the presence of abundant intra-articular effusion.
Do not re-sterilize. The device is intended for single use only. Do not reuse to avoid any risk of contamination.
Once opened, it must be used immediately and disposed of after use.
Keep out of reach and sight of children.
After intra-articular injection or into the tendon synovium, advise the patient to avoid all intense physical activities and to resume normal activities only after a few days.
The possible presence of an air bubble does not compromise the characteristics of the product.
Do not mix SINOVIAL 50 2.5 ml with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
Extra-articular infiltration of SINOVIAL 50 2.5 ml may cause local undesirable effects. During the use of SINOVIAL 50 2.5 ml, symptoms such as pain, warmth, redness, or swelling may occur at the injection site. These secondary manifestations can be alleviated by applying ice to the treated area. Normally, they disappear after a short time. The physician must ensure that patients inform them of any adverse effects occurring after treatment.
SINOVIAL 50 2.5 ml should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the injection site area.
The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.
To date, no interactions between SINOVIAL 50 2.5 ml and other drugs are known.
Do not mix with disinfectants such as quaternary ammonium salts or chlorhexidine as a precipitate may form.
It should not be injected in the presence of an infected or severely inflamed joint or if the patient has a skin condition or infection in the injection site area. The product should not be used in case of known hypersensitivity to sodium hyaluronate or other components.
SINOVIAL 50 2.5 ml can only be injected by a physician.
Storage
Store at room temperature and below 25 °C, away from heat sources. Do not freeze.
Validity of unopened packaging: 36 months.
Format
Package containing 1 pre-filled syringe (50.0 mg of sodium hyaluronate in 2.5 ml of buffered saline solution) and 1 needle 21G x 1 ½" (0.8 x 40 mm).
our satisfaction is our priority. If you have changed your mind about your purchase, you have 14 days from the delivery date to inform us and return the product.
Conditions: The product must be perfectly intact, unused, and returned in its sealed original packaging. For hygiene reasons, we cannot accept products that have been opened.
Procedure: To initiate a return, contact our Customer Service at customercare@dermadea.com.
Shipping Costs: The shipping costs for returning the product are your responsibility.
For all the details, please consult our General Terms and Conditions of Sale.
We are committed to providing you with perfect products. If you receive a damaged, defective, or incorrect item, you are protected by the Legal Guarantee of Conformity.
What to Do: Immediately contact our Customer Service at customercare@dermadea.com, describing the issue and attaching a photo of the product if possible.
Solution: We will arrange for a product replacement or a full refund, depending on the situation.
Shipping Costs: In the event of a defective or non-compliant product, the shipping costs for the return are entirely at our expense.
For all the details, please consult our General Terms and Conditions of Sale.
