Descrizione Clinica
INNORYOS
Description
The product contains a pre-packed injection of hydrogel containing highly purified hyaluronate sodium, obtained by bacterial fermentation with high molecular weight, useful to improve the viscosity of intra-articular connective tissue. It has been subjected to steam sterilization for injectable products and is not pyrogen.
A milliliter of aqueous and physiological phosphate buffer solution contains 16 mg, 22 mg or 25 mg of hyaluronate sodium, depending on the variant of product and concentration. Hyaluronic acid hydrogel is found in a weak, sterile, isotonic and apirogenous phosphate buffer solution with a pH of 7.2 (6.8 - 7.4) and a sufficient volume to injection. Filling volumes are 1 - 4.8 ml, according to the variant.
Glycosamynoglycan hyaluronic acid is a fundamental component of healthy synovial fluid. This natural biopolymer ensures viscoelacity and makes it possible, thanks to its lubricating and cushioning characteristics, physiological movements without pain; also provides nutrients to cartilage. Hyaluronate sodium in INNORYOS is a salt of hyaluronic acid.
Pain and limited joint mobility in case of degenerative modifications of knee joints and other synovial joints, including osteoarthritis.
Mode of use
The pre-packaged syringe must be taken from its packaging. The protection cap must be removed from the Luer-Lock thread. Screw a suitable sterile injection needle on the syringe. We recommend using a disposable needle. Before injection it is necessary to remove the air from the syringe. The part of injection skin must be deterred with a suitable topical antiseptic product. In case of joint pouring, it is recommended to reduce the pouring by suction and to examine the bacterial etiology before proceeding with INNORYOS injection. Hydrogel can be injected intra-articularly from 1 to 5 times at intervals determined by the doctor. The beneficial effects of treatment last at least 6 months. Treatment cycles can be repeated if necessary.
Depending on the filling volume, several joints of a patient can be treated simultaneously. The unused product must be eliminated.
Warnings
The product cannot be applied in patients presenting:
- a known sensitivity against one of the components;
- an inflammation of the joint;
- a septic arthritis;
- skin infections or skin diseases in the injection area;
- natural or pharmacological reduction of coagulation as hemophilia or in anticoagulant therapy such as Marcumar (fenprocumone) or Coumadin (warfarin).
Because clinical data relating to the use of hyaluronic acid in children, pregnant women or breastfeeding are not available, we do not recommend the use for these categories of people.
Since septic arthritis can represent a serious collateral phenomenon of treatment, please observe all precautionary measures typical of surgery. Hydrogel injections must be done exactly in the knee cavity; are to avoid injections in blood vessels and in the adjacent tissue. Do not use if the pre-packed syringe or sterile packaging is damaged. The open product cannot be sterilized again, closed or reused. The use is reserved for a single patient in a single session.
Local phenomena such as pain, redness, feeling of warmth and swelling may occur at the treated joint. These phenomena can be avoided by cooling the treated area by a frozen tablet for about 5 to 10 minutes after injection. During the first days of treatment it can be useful to take oral pain medications and anti-inflammatory drugs (NSAIDs). In case of intense color or inflammation, it is necessary to stop treatment. The treatment of adverse reactions must take place exclusively under the supervision of the attending physician. Immediately after injection it is necessary to avoid intense physical activity and you must follow the indications of the doctor.
The medical staff must inform the patient:
- on possible adverse events related to the product;
- that the patient must report to a doctor any adverse event or complication.
The product must be kept outside the reach of children.
Use intended exclusively for doctors.
Disposable. Do not sterilize again. Do not use syringes, needles and hydrogels from open or damaged packages, and do not try to close the packages.
The content of the syringe is not toxic and is not flammable.
In case of use of a product coming from a damaged package or in case of reuse for other patients or for the same patient at another time, the expected characteristics and sterility are not ensured. In case of non-compliance, the possible transmission of contaminated material and pathogenic agents from the environment, clinical environment or (other) patients could lead to health complications. Restoring or sterilizing again does not represent any permitted or guaranteed replenishment of the usability state.
Unused syringes and their content are not infectious and can be eliminated both before and after their expiry date, in compliance with national and local regulations. The syringes used and needles must be considered as hazardous waste from the epidemiological point of view and eliminated in compliance with national and local regulations for safe use and elimination.
Conservation
The product must be kept dry at a temperature between 2 °C and 25°C, sheltered from light and shocks, inside its original packaging. It is therefore necessary to respect the warning symbols present on the package.
Format
2 ml syringe case.
The product contains a pre-packed injection of hydrogel containing highly purified hyaluronate sodium, obtained by bacterial fermentation with high molecular weight, useful to improve the viscosity of intra-articular connective tissue. It has been subjected to steam sterilization for injectable products and is not pyrogen.
A milliliter of aqueous and physiological phosphate buffer solution contains 16 mg, 22 mg or 25 mg of hyaluronate sodium, depending on the variant of product and concentration. Hyaluronic acid hydrogel is found in a weak, sterile, isotonic and apirogenous phosphate buffer solution with a pH of 7.2 (6.8 - 7.4) and a sufficient volume to injection. Filling volumes are 1 - 4.8 ml, according to the variant.
Glycosamynoglycan hyaluronic acid is a fundamental component of healthy synovial fluid. This natural biopolymer ensures viscoelacity and makes it possible, thanks to its lubricating and cushioning characteristics, physiological movements without pain; also provides nutrients to cartilage. Hyaluronate sodium in INNORYOS is a salt of hyaluronic acid.
Pain and limited joint mobility in case of degenerative modifications of knee joints and other synovial joints, including osteoarthritis.
Mode of use
The pre-packaged syringe must be taken from its packaging. The protection cap must be removed from the Luer-Lock thread. Screw a suitable sterile injection needle on the syringe. We recommend using a disposable needle. Before injection it is necessary to remove the air from the syringe. The part of injection skin must be deterred with a suitable topical antiseptic product. In case of joint pouring, it is recommended to reduce the pouring by suction and to examine the bacterial etiology before proceeding with INNORYOS injection. Hydrogel can be injected intra-articularly from 1 to 5 times at intervals determined by the doctor. The beneficial effects of treatment last at least 6 months. Treatment cycles can be repeated if necessary.
Depending on the filling volume, several joints of a patient can be treated simultaneously. The unused product must be eliminated.
Warnings
The product cannot be applied in patients presenting:
- a known sensitivity against one of the components;
- an inflammation of the joint;
- a septic arthritis;
- skin infections or skin diseases in the injection area;
- natural or pharmacological reduction of coagulation as hemophilia or in anticoagulant therapy such as Marcumar (fenprocumone) or Coumadin (warfarin).
Because clinical data relating to the use of hyaluronic acid in children, pregnant women or breastfeeding are not available, we do not recommend the use for these categories of people.
Since septic arthritis can represent a serious collateral phenomenon of treatment, please observe all precautionary measures typical of surgery. Hydrogel injections must be done exactly in the knee cavity; are to avoid injections in blood vessels and in the adjacent tissue. Do not use if the pre-packed syringe or sterile packaging is damaged. The open product cannot be sterilized again, closed or reused. The use is reserved for a single patient in a single session.
Local phenomena such as pain, redness, feeling of warmth and swelling may occur at the treated joint. These phenomena can be avoided by cooling the treated area by a frozen tablet for about 5 to 10 minutes after injection. During the first days of treatment it can be useful to take oral pain medications and anti-inflammatory drugs (NSAIDs). In case of intense color or inflammation, it is necessary to stop treatment. The treatment of adverse reactions must take place exclusively under the supervision of the attending physician. Immediately after injection it is necessary to avoid intense physical activity and you must follow the indications of the doctor.
The medical staff must inform the patient:
- on possible adverse events related to the product;
- that the patient must report to a doctor any adverse event or complication.
The product must be kept outside the reach of children.
Use intended exclusively for doctors.
Disposable. Do not sterilize again. Do not use syringes, needles and hydrogels from open or damaged packages, and do not try to close the packages.
The content of the syringe is not toxic and is not flammable.
In case of use of a product coming from a damaged package or in case of reuse for other patients or for the same patient at another time, the expected characteristics and sterility are not ensured. In case of non-compliance, the possible transmission of contaminated material and pathogenic agents from the environment, clinical environment or (other) patients could lead to health complications. Restoring or sterilizing again does not represent any permitted or guaranteed replenishment of the usability state.
Unused syringes and their content are not infectious and can be eliminated both before and after their expiry date, in compliance with national and local regulations. The syringes used and needles must be considered as hazardous waste from the epidemiological point of view and eliminated in compliance with national and local regulations for safe use and elimination.
Conservation
The product must be kept dry at a temperature between 2 °C and 25°C, sheltered from light and shocks, inside its original packaging. It is therefore necessary to respect the warning symbols present on the package.
Format
2 ml syringe case.
