Description
INNORYOS
Description
The product contains a pre-packaged injection of highly purified sodium hyaluronate hydrogel, obtained by bacterial fermentation with high molecular weight, useful for improving the viscosity of intra-articular connective tissue. It has been subjected to steam sterilization for injectable products and is not pyrogenic.
One milliliter of aqueous, physiological phosphate buffer solution contains 16 mg, 22 mg or 25 mg of sodium hyaluronate, depending on the product variant and concentration. The hyaluronic acid hydrogel is in a weak, sterile, isotonic, pyrogen-free saline phosphate buffer solution with a pH of 7.2 (6.8 - 7.4) and a volume sufficient for injection. Filling volumes are 1 - 4.8 ml, depending on the variant.
The widely distributed glycosaminoglycan hyaluronic acid is a key component of healthy synovial fluid. This natural biopolymer ensures viscoelasticity and enables pain-free physiological movements due to its lubricating and cushioning properties; it also provides nutrients to the cartilage. The sodium hyaluronate contained in INNORYOS is a salt of hyaluronic acid.
Pain and limited joint mobility in degenerative changes of the knee joint and other synovial joints, including osteoarthritis.
How to use
The pre-packaged syringe should be removed from its packaging. The protective cap should be removed from the Luer-Lock thread. Screw a suitable sterile injection needle onto the syringe. The use of a disposable needle is recommended. Before injection, the air should be removed from the syringe. The area of skin intended for injection should be cleansed with an appropriate topical antiseptic product. In case of joint effusion, it is recommended to reduce the effusion by aspiration and to examine its bacterial etiology, before proceeding with the injection of INNORYOS. The hydrogel can be injected intra-articularly 1 to 5 times at intervals determined by the physician. The beneficial effects of a 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. Unused product should be discarded.
Warnings
The product cannot be applied to patients with:
- a known sensitivity to one of the components;
- an inflammation of the joint;
- septic arthritis;
- skin infections or skin diseases at the injection site;
- natural or pharmacological reduction of coagulation such as haemophilia or in anticoagulant therapy such as Marcumar (phenprocoumon) or Coumadin (warfarin).
Since there are no clinical data available on the use of hyaluronic acid in children, pregnant or breastfeeding women, its use is not recommended for these categories of people.
Since septic arthritis can be a serious side effect of treatment, please observe all precautionary measures typical of surgical interventions. Hydrogel injections must be made exactly into the knee cavity; injections into blood vessels and adjacent tissue should be avoided. Do not use if the pre-packaged syringe or sterile packaging is damaged. The opened product cannot be re-sterilized, resealed or reused. Use is reserved for a single patient in a single application session.
Local symptoms such as pain, redness, heat and swelling may occur at the treated joint. These symptoms can be avoided by cooling the treated area with an ice pack for about 5 - 10 minutes after the injection. During the first few days of treatment, it may be helpful to take oral painkillers and anti-inflammatory drugs (NSAIDs). In the event of intense redness or inflammation, treatment should be stopped. Treatment of adverse reactions should be done only under the supervision of your doctor. Immediately after the injection, you should avoid intense physical activity and follow your doctor's instructions.
Medical personnel must inform the patient:
- on possible adverse events related to the product;
- that the patient should report any adverse events or complications to a physician.
The product must be kept out of reach of children.
For use by physicians only.
Single use only. Do not re-sterilize. Do not use syringes, needles, and hydrogel from opened or damaged packages, and do not attempt to reseal packages.
The contents of the syringe are non-toxic and non-flammable.
If a product is used from a damaged package or if it is reused for other patients or for the same patient at another time, the intended properties and sterility are not ensured. In the event of non-compliance, the possible transmission of contaminated material and pathogens from the environment, the clinical environment or (other) patients could lead to health complications. Reclosing or re-sterilizing does not represent any permitted or guaranteed reconstitution of the usable state.
Unused syringes and their contents are non-infectious and can be disposed of both before and after their expiry date, in accordance with national and local regulations. Used syringes and needles should be considered as epidemiologically hazardous waste and disposed of in accordance with national and local regulations for safe use and disposal.
Conservation
The product must be stored in a dry place at a temperature between 2°C and 25°C, away from light and shock, in its original packaging. It is therefore necessary to respect the warning symbols on the packaging.
Format
Case with 2 ml syringe.
The product contains a pre-packaged injection of highly purified sodium hyaluronate hydrogel, obtained by bacterial fermentation with high molecular weight, useful for improving the viscosity of intra-articular connective tissue. It has been subjected to steam sterilization for injectable products and is not pyrogenic.
One milliliter of aqueous, physiological phosphate buffer solution contains 16 mg, 22 mg or 25 mg of sodium hyaluronate, depending on the product variant and concentration. The hyaluronic acid hydrogel is in a weak, sterile, isotonic, pyrogen-free saline phosphate buffer solution with a pH of 7.2 (6.8 - 7.4) and a volume sufficient for injection. Filling volumes are 1 - 4.8 ml, depending on the variant.
The widely distributed glycosaminoglycan hyaluronic acid is a key component of healthy synovial fluid. This natural biopolymer ensures viscoelasticity and enables pain-free physiological movements due to its lubricating and cushioning properties; it also provides nutrients to the cartilage. The sodium hyaluronate contained in INNORYOS is a salt of hyaluronic acid.
Pain and limited joint mobility in degenerative changes of the knee joint and other synovial joints, including osteoarthritis.
How to use
The pre-packaged syringe should be removed from its packaging. The protective cap should be removed from the Luer-Lock thread. Screw a suitable sterile injection needle onto the syringe. The use of a disposable needle is recommended. Before injection, the air should be removed from the syringe. The area of skin intended for injection should be cleansed with an appropriate topical antiseptic product. In case of joint effusion, it is recommended to reduce the effusion by aspiration and to examine its bacterial etiology, before proceeding with the injection of INNORYOS. The hydrogel can be injected intra-articularly 1 to 5 times at intervals determined by the physician. The beneficial effects of a 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. Unused product should be discarded.
Warnings
The product cannot be applied to patients with:
- a known sensitivity to one of the components;
- an inflammation of the joint;
- septic arthritis;
- skin infections or skin diseases at the injection site;
- natural or pharmacological reduction of coagulation such as haemophilia or in anticoagulant therapy such as Marcumar (phenprocoumon) or Coumadin (warfarin).
Since there are no clinical data available on the use of hyaluronic acid in children, pregnant or breastfeeding women, its use is not recommended for these categories of people.
Since septic arthritis can be a serious side effect of treatment, please observe all precautionary measures typical of surgical interventions. Hydrogel injections must be made exactly into the knee cavity; injections into blood vessels and adjacent tissue should be avoided. Do not use if the pre-packaged syringe or sterile packaging is damaged. The opened product cannot be re-sterilized, resealed or reused. Use is reserved for a single patient in a single application session.
Local symptoms such as pain, redness, heat and swelling may occur at the treated joint. These symptoms can be avoided by cooling the treated area with an ice pack for about 5 - 10 minutes after the injection. During the first few days of treatment, it may be helpful to take oral painkillers and anti-inflammatory drugs (NSAIDs). In the event of intense redness or inflammation, treatment should be stopped. Treatment of adverse reactions should be done only under the supervision of your doctor. Immediately after the injection, you should avoid intense physical activity and follow your doctor's instructions.
Medical personnel must inform the patient:
- on possible adverse events related to the product;
- that the patient should report any adverse events or complications to a physician.
The product must be kept out of reach of children.
For use by physicians only.
Single use only. Do not re-sterilize. Do not use syringes, needles, and hydrogel from opened or damaged packages, and do not attempt to reseal packages.
The contents of the syringe are non-toxic and non-flammable.
If a product is used from a damaged package or if it is reused for other patients or for the same patient at another time, the intended properties and sterility are not ensured. In the event of non-compliance, the possible transmission of contaminated material and pathogens from the environment, the clinical environment or (other) patients could lead to health complications. Reclosing or re-sterilizing does not represent any permitted or guaranteed reconstitution of the usable state.
Unused syringes and their contents are non-infectious and can be disposed of both before and after their expiry date, in accordance with national and local regulations. Used syringes and needles should be considered as epidemiologically hazardous waste and disposed of in accordance with national and local regulations for safe use and disposal.
Conservation
The product must be stored in a dry place at a temperature between 2°C and 25°C, away from light and shock, in its original packaging. It is therefore necessary to respect the warning symbols on the packaging.
Format
Case with 2 ml syringe.
