Instructions Osteolon solution for injection 2.25 mg/ml ampoule 1 ml No. 25
Composition
active ingredient: extract from bone marrow and intercostal cartilages of young calves;
1 ml of solution contains: 1 ml of extract from bone marrow and intercostal cartilage of young calves, containing at least 2.25 mg of glycosaminoglycan-peptide complex;
Excipients: metacresol, 0.1 M hydrochloric acid solution, water for injection.
Dosage form
Solution for injection.
Main physicochemical properties: transparent yellowish-brown solution with the smell of metacresol, without mechanical inclusions.
Pharmacotherapeutic group
Means used in pathologies of the musculoskeletal system. ATX code M09A X.
Pharmacological properties
Pharmacodynamics
The drug Osteolon contains a glycosaminoglycan-peptide complex from cartilage and bone marrow of young calves (up to 6 months old). It affects the disturbed metabolism in cartilage hyaline tissue. The drug enhances the biosynthesis of sulfated mucopolysaccharides. Stimulates the regeneration of articular cartilage and inhibits catabolic processes in cartilage tissue.
Osteolon belongs to the group of chondroprotectors - drugs that slow down the progression of osteoarthritis, normalize metabolism in hyaline cartilage tissue. It stimulates the synthesis of glycosaminoglycans and collagen of cartilage tissue, reduces the activity of enzymes that contribute to the destruction of articular cartilage, improves trophicity of articular cartilage, enhances regeneration and hyalinization of joint cartilage, increases the amount of synovial fluid, slows down the development of osteoarthritis.
Pharmacokinetics
No studies have been conducted.
Indication
Degenerative changes in the joints: gonarthrosis, arthrosis of the interdigital joints, coxarthrosis, spondylosis, spondyloarthrosis, meniscopathy, chondromalacia of the patella.
Contraindication
Hypersensitivity to the components of the drug. Rheumatoid arthritis. Age under 18 years. Pregnancy, breastfeeding. Use in women of reproductive age who do not use reliable methods of contraception.
Interaction with other medicinal products and other types of interactions
Osteolon can be used simultaneously with nonsteroidal anti-inflammatory drugs and glucocorticosteroids.
When used simultaneously with indirect anticoagulants, antiplatelet agents and fibrinolytics, their effects may be enhanced.
Application features
Before starting treatment, the patient should consult a doctor to rule out the presence of systemic autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, scleroderma), in case of which specific treatment should be prescribed.
The drug contains metacresol, which may cause allergic reactions.
When used simultaneously with indirect anticoagulants, antiplatelet agents and fibrinolytics, frequent monitoring of blood coagulation should be carried out.
Use during pregnancy or breastfeeding
There are no data on the use of Osteolon in pregnant women. The use of the drug during pregnancy or breastfeeding is contraindicated.
Ability to influence reaction speed when driving vehicles or other mechanisms
Missing data.
Method of administration and doses
The drug is administered deeply intramuscularly: on the first day - 0.3 ml, on the second day - 0.5 ml and then 3 times a week, 1 ml for 5-6 weeks. A repeated course of treatment is carried out according to the same scheme, after consulting a doctor.
Children
Osteolone is not recommended for use in children, as there is no data on the safety and effectiveness of treatment in this category of patients.
Overdose
No cases of overdose were observed.
Side effects
Adverse effects are classified by frequency of occurrence into the following categories: very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1000 - <1/100), rare (≥ 1/10000 - < 1/1000), very rare (< 1/10000), unknown (frequency not determined based on available data).
From the immune system.
Rare: allergic reactions, including anaphylactoid reactions, anaphylactic shock, swelling of the neck area.
On the part of the musculoskeletal system: sometimes after 3-6 injections, increased pain in the joints is observed, which resolves on its own and does not require discontinuation of the drug.
If side effects not described in this instruction appear, you should stop taking the drug and inform your doctor.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
1 ml or 2 ml in an ampoule, 5 ampoules in a blister, 1, 2 or 5 blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
K.T. Rompharm Company S.R.L.
Address
Eroilor St. No. 1A, Otopeni, 075100, Ilfov County, Romania.
