Dona solution for intramuscular injection 200mg/ml in 2ml ampoules complete with solvent No. 6

Name:
of the Don.
Description:
Solution A is a clear, colorless or light brown clear liquid free of particles in suspension; solution B is a clear, colorless liquid that does not contain suspended particles; Solution A plus Solution B is a light brown, clear solution free of particles in suspension. The main active ingredient Release formSolution for intramuscular injection. Dosage 200 mg / 1 ml 2 ml. Special instructionsPharmacological action Other non-steroidal anti-inflammatory and antirheumatic drugs. ATH code: M01AX05. Pharmacodynamics Mechanism of action. Glucosamine sulfate is a salt of the amino monosaccharide glucosamine, which is an endogenous component and a preferred substrate for the synthesis of glycosaminoglycans and proteoglycans in articular cartilage and synovial fluid. Glucosamine sulfate inhibits the activity of interleukin-1 beta and other inflammatory mediators. Clinical efficacy and tolerability The safety and efficacy of glucosamine sulfate has been confirmed in clinical trials with a treatment duration (oral administration) of up to three years. Short- and medium-term clinical studies have shown that the effectiveness of glucosamine sulfate in relation to the symptoms of osteoarthritis is observed after 2-3 weeks of its use. However, unlike NSAIDs, glucosamine sulfate has a long-term effect that lasts from 6 months to 3 years. Clinical studies with daily administration of glucosamine sulfate for up to 3 years have shown a gradual improvement in symptoms of the disease and a slowdown in structural changes in the joint, as demonstrated by radiography. Glucosamine sulfate has been shown to be well tolerated during short and long-term treatment courses. Evidence of the effectiveness of the drug was demonstrated when it was taken for three months, with a residual effect for two months after its withdrawal. The safety and efficacy of the drug have also been confirmed in clinical trials for up to three years of use. Continuous treatment for more than 3 years cannot be recommended, as there are no safety data when taking glucosamine for more than 3 years. Pharmacokinetics Glucosamine is a relatively small molecule (molecular weight 179) that is readily soluble in water and hydrophilic organic solvents. Limited information is available on the pharmacokinetics of intramuscularly administered glucosamine. Absolute bioavailability is unknown. The volume of distribution is approximately 5 liters, and the elimination half-life after intravenous administration is approximately 2 hours. Approximately 38% of an intravenously administered dose is excreted in the urine unchanged. Indications for use Relief of symptoms (mild to moderate pain) in adequately diagnosed osteoarthritis of the knee. Method of application and doses For intramuscular use! The drug is not intended for intravenous administration. Adult and elderly patients Before use, mix solution B (solvent 1 ml) with solution A (drug solution 2 ml) in one syringe. The prepared solution of the drug is administered intramuscularly in 3 ml or 6 ml (solution A – B) 3 times a week for 4-6 weeks. The presence of a yellowish color of the solution in ampoule A does not affect the efficacy and tolerability of the drug. Injections of the drug can be combined with oral administration of the drug in the form of a powder to prepare a solution. Glucosamine is not intended for the treatment of acute pain. Relief of symptoms (especially reduction of pain) may occur only after several weeks of treatment, and in some cases even after a longer time. If no improvement in symptoms occurs after 2-3 months of use, treatment should be reassessed. Patients should seek medical advice if pain worsens after starting glucosamine. Dosing regimen for different categories of patents Elderly patients Dose adjustment is not required. Patients with impaired renal and / or liver function In patients with impaired renal and / or liver function, no recommendations for dose adjustment exist, since no relevant studies have been conducted. Children and adolescents Glucosamine should not be used in children and adolescents under the age of 18 years, as there are no data on the safety and efficacy of glucosamine in this category of patients. Use during pregnancy and lactation There are no data on the use of the drug in pregnant women or during lactation, so the use of the drug during pregnancy or lactation is not recommended. Influence on the ability to drive vehicles and other mechanisms Studies on the effect of the drug on the ability to drive a car and other mechanisms have not been conducted. You should be careful when driving vehicles and performing work that requires attention. In case of headache, drowsiness, fatigue, dizziness or visual impairment, driving or operating other mechanisms is not recommended. Precautions It is necessary to consult a doctor to exclude the presence of joint disease for which other methods of treatment are provided. Cases of exacerbation of symptoms of bronchial asthma after the start of taking glucosamine are described. Patients suffering from bronchial asthma should be informed about the possible worsening of the symptoms of the disease. One dose of the drug contains 40.3 mg of sodium. This should be taken into account when prescribing to patients on a sodium-restricted diet. Patients with impaired glucose tolerance should be careful when taking glucosamine. Patients with diabetes are advised to monitor blood sugar levels and determine insulin requirements before starting and periodically during treatment. No special studies have been conducted in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of glucosamine does not suggest limitations for these patients. However, the use of glucosamine in patients with severe hepatic or renal insufficiency should be carried out under the supervision of a physician. Interaction with other drugs No specific drug interaction studies have been conducted. There is evidence of an increase in the effect of coumarin anticoagulants, therefore, in patients who are simultaneously taking coumarin anticoagulants (for example, warfarin or acenocoumarol), more careful monitoring of coagulation parameters is necessary. Oral administration of glucosamine sulfate may increase the absorption of tetracyclines in the gastrointestinal tract, but the clinical significance of this interaction is small. It is acceptable to take steroidal or non-steroidal anti-inflammatory drugs at the same time as glucosamine. ContraindicationsIndividual hypersensitivity to the active substance or to any of the excipients. The drug should not be used in patients with shellfish allergy, since the active substance (glucosamine) is obtained from the shells of molluscs and crustaceans. Pregnancy and the period of breastfeeding. The composition of the injection form of the drug includes the excipient lidocaine, which has the following contraindications: arrhythmia, acute heart failure, and hypersensitivity to lidocaine. Composition Solution A: each ampoule (2 ml) contains: active substance: glucosamine sulfate crystalline 502.5 mg (contains 400 mg glucosamine sulfate and 102.5 mg sodium chloride); excipients: lidocaine hydrochloride 10.0 mg, water for injection up to 2 ml. Solution B: 1 ml ampoule contains: excipients: diethanolamine – 24.0 mg, water for injection up to 1 ml. Overdose Cases of overdose are unknown. In cases of overdose, symptomatic treatment should be carried out aimed at restoring the water and electrolyte balance. Side effects To determine the frequency of adverse events, the following categories of their occurrence in patients were used: Very often (≥ 1/10) Often (≥ 1/100 to < 1/10) Infrequently (≥ 1/1000 to < 1/100) Rarely (≥ 1/10,000 to < 1/1000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data). General adverse event profile The most common adverse reactions associated with intramuscular administration of glucosamine are nausea, abdominal pain, dyspepsia, flatulence, constipation and diarrhea, rarely skin irritation, itching and redness. Injectable forms of glucosamine due to the content of lidocaine can sometimes cause nausea and vomiting (rarely). These adverse reactions, as a rule, were moderately severe and transient. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. for Don solution for intramuscular injection 200 mg/ml in ampoules 2 ml complete with solvent No. 6