Instructions for Artiflex Chondro injection solution 100 mg/ml ampoule 2 ml No. 10
Composition
active ingredient: chondroitin sulfate;
1 ml of solution contains chondroitin sodium sulfate 100 mg;
Excipients: benzyl alcohol, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent, colorless or slightly yellowish liquid with the odor of benzyl alcohol.
Pharmacotherapeutic group
Means affecting the musculoskeletal system. Chondroitin sulfate. ATX code M01A X25.
Pharmacological properties
Pharmacodynamics
The main active ingredients of the drug are sodium salts of chondroitin sulfate A and C (average molecular weight 11,000 daltons). Chondroitin sulfate is a high-molecular mucopolysaccharide. It is the main component of proteoglycans, which together with collagen fibers form the cartilage matrix.
The drug inhibits the process of degeneration and stimulates the regeneration of cartilage tissue, has a chondroprotective, anti-inflammatory, analgesic effect. Replaces chondroitin sulfate of articular cartilage, catabolized by the pathological process. Inhibits the activity of enzymes that cause degradation of articular cartilage; inhibits metalloproteinases, namely leukocyte elastase. Reduces the activity of hyaluronidase. Partially blocks the release of free oxygen radicals; helps block chemotaxis, antigenic determinants. Stimulates the production of proteoglycans by chondrocytes. Affects phosphorus-calcium metabolism in cartilage tissue. Allows you to restore the mechanical and elastic integrity of the cartilage matrix. Anti-inflammatory and analgesic effects are achieved by reducing the release of inflammatory mediators and pain factors into the synovial fluid by synoviocytes and macrophages of the synovial membrane, as well as by inhibiting the secretion of leukotriene B and prostaglandin E.
The use of the drug promotes the restoration of the joint capsule and cartilaginous surfaces of the joints, prevents compression of the connective tissue, acts as a lubricant for the joint surfaces, normalizes the production of joint fluid, improves joint mobility, helps reduce the intensity of pain, and improves the quality of life.
The drug slows down bone resorption and reduces calcium loss, accelerating bone tissue repair processes.
Pharmacokinetics
After intramuscular injection of chondroitin sulfate penetrates into the synovial fluid. Cmax in the synovial fluid is reached 4–5 hours after injection. It is excreted from the body within 24 hours. It is eliminated mainly by the kidneys.
Indication
Degenerative-dystrophic diseases of the joints and spine (primary arthrosis, intervertebral osteochondrosis, osteoarthritis), osteoporosis, periodontal diseases, fractures (to accelerate the formation of bone callus), as well as for the purpose of treating the consequences of joint surgeries.
Contraindication
Increased individual sensitivity to any of the components of the drug, tendency to bleeding, thrombophlebitis, renal failure, liver failure in the decompensation stage, pregnancy, breastfeeding, children's age.
Use with caution: in case of blood clotting disorders; diabetes; people with high body weight; in case of impaired kidney function; women planning pregnancy.
Interaction with other medicinal products and other types of interactions
When used simultaneously with glucocorticosteroids and nonsteroidal anti-inflammatory drugs, chondroitin sulfate can reduce the need for them, as well as the need for painkillers. It shows synergism of action when used simultaneously with glucosamine and other chondroprotectors. The effectiveness of treatment increases when enriching the diet with vitamins A, C and salts of manganese, magnesium, copper, zinc and selenium.
When used simultaneously with acetylsalicylic acid or other anticoagulants or antiplatelet agents, it is recommended to monitor blood clotting. When used simultaneously with tetracyclines, chondroitin may affect the concentration of tetracycline in the blood serum.
Application features
To achieve a stable clinical effect, at least 25 injections of the drug are required. The effect persists for many months after the end of treatment. To prevent exacerbations, repeated courses of treatment should be used. It is recommended to increase doses under the supervision of a physician for patients with excess body weight, peptic ulcer of the stomach or duodenum, while taking diuretics, as well as at the beginning of treatment if it is necessary to accelerate the clinical response.
In case of allergic reactions or hemorrhages, treatment should be discontinued.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no restrictions on driving vehicles and complex mechanisms when using the drug.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Method of administration and doses
The drug is administered intramuscularly to adults in a dose of 1 ml every other day. If well tolerated, the dose is increased to 2 ml, starting with the fourth injection. The course of treatment is 25–35 injections. Repeated courses are carried out after 6 months.
Children
There is no experience with the use of the drug in children.
Overdose
At present, no cases of overdose have been reported when using the drug. However, it can be assumed that if the daily dose is exceeded, the side effects of the drug may be increased. Treatment is symptomatic.
Adverse reactions
When used in patients with hypersensitivity to the drug, the following disorders are possible:
from the immune system: allergic reactions, anaphylactic shock, angioedema;
Skin and subcutaneous tissue disorders: skin rash, itching, erythema, urticaria, dermatitis, alopecia; changes at the injection site, including redness and itching;
Gastrointestinal: nausea, vomiting, abdominal pain, flatulence, dyspeptic symptoms, diarrhea;
others: visual disturbances, keratopathy, dizziness, peripheral edema.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
2 ml in syringes, 5 syringes complete with needles in a box.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Location of the manufacturer and its business address
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
