Elbona^® (Solution, Powder) Instructions for Use

Instructions
Dosage forms

ATC Code

M01AX05 (Glucosamine)

Active Substance

Glucosamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug stimulating the process of regeneration of cartilage tissue

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

A drug affecting the metabolism in cartilage tissue. It has anti-inflammatory and analgesic effects, replenishes endogenous glucosamine deficiency, stimulates the synthesis of proteoglycans and hyaluronic acid in the synovial fluid; increases the permeability of the joint capsule, restores enzymatic processes in the cells of the synovial membrane and articular cartilage.

It promotes sulfur fixation in the process of chondroitin sulfuric acid synthesis, facilitates normal calcium deposition in bone tissue, inhibits the development of degenerative processes in the joints, restores their function, and reduces joint pain.

Pharmacokinetics

The bioavailability of glucosamine after oral administration is 25% due to the first-pass effect through the liver.

The highest concentrations of glucosamine are found in the liver, kidneys, and articular cartilage.

It is excreted mainly unchanged in the urine; partially in the feces.

T_1/2 is 68 hours.

Indications

For the relief of symptoms in adult patients with mild to moderate osteoarthritis affecting the knee joint.
For the management of symptoms associated with scapulohumeral periarthritis, also known as adhesive capsulitis of the shoulder, in adults.

The use is aimed at reducing pain and improving joint function in these specified conditions.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
M15	Polyosteoarthritis
M22.4	Chondromalacia patellae
M42	Spinal osteochondrosis
M47	Spondylosis
M75.0	Adhesive capsulitis of shoulder

ICD-11 code	Indication
FA05	Polyosteoarthritis
FA85.Z	Defects of vertebral end-plates, unspecified
FA8Z	Degenerative disease of spine, unspecified
FB53.0	Adhesive capsulitis of shoulder
FB82.00	Chondromalacia patellae

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally, intramuscularly, or externally as directed. The specific dosage and the duration of the treatment course must be determined on an individual basis by the prescribing healthcare professional.

Follow the prescribed route of administration and do not exceed the recommended dose. The regimen may be adjusted based on the patient’s response to therapy and the severity of the condition being treated.

Adverse Reactions

Gastrointestinal disturbances are the most commonly reported adverse effects. These include pain in the epigastric region, nausea, flatulence, diarrhea, and constipation.

Allergic reactions, such as skin rash, pruritus, and urticaria, may occur. Monitor for any signs of hypersensitivity during treatment.

Contraindications

Do not use in patients with a known hypersensitivity or allergy to glucosamine or any of the excipients in the formulation.
Contraindicated in patients with phenylketonuria if the product contains aspartame as an ingredient.
Avoid use in patients with severe chronic renal failure.
Do not administer to children under the age of 12 years.
Contraindicated during pregnancy and throughout the breastfeeding period.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Use is contraindicated in severe chronic renal failure.

Pediatric Use

Use is contraindicated in children under 12 years of age.

Special Precautions

Medical supervision is required when used in patients with impaired glucose tolerance, with severe hepatic and renal insufficiency.

The risk of allergic reactions increases with seafood intolerance.

Drug Interactions

Concomitant administration may lead to a clinically significant increase in the absorption of tetracycline antibiotics from the gastrointestinal tract.

Conversely, a reduction in the absorption of penicillins and chloramphenicol may be observed. The drug is considered compatible with nonsteroidal anti-inflammatory drugs and systemic corticosteroids.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Elbona^® [Ellara, LLC (Russia)]
Powder for oral solution 1.5 g: 2.2 g sachet 5, 7, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49 or 50 pcs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Elbona^®

Powder for oral solution 1.5 g: 2.2 g sachet 5, 7, 14, 20, 21, 25, 28, 30, 35, 40, 42, 49 or 50 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution white or white with a slightly yellowish tint.

	1 sachet
Glucosamine sulfate sodium chloride	1.884 g,
Equivalent to glucosamine sulfate content	1.5 g

Excipients : sorbitol – 0.303 g, citric acid – 0.013 g.

2.2 g – sachets (5) – cardboard packs.
2.2 g – sachets (7) – cardboard packs.
2.2 g – sachets (14) – cardboard packs.
2.2 g – sachets (20) – cardboard packs.
2.2 g – sachets (21) – cardboard packs.
2.2 g – sachets (25) – cardboard packs.
2.2 g – sachets (28) – cardboard packs.
2.2 g – sachets (30) – cardboard packs.
2.2 g – sachets (35) – cardboard packs.
2.2 g – sachets (40) – cardboard packs.
2.2 g – sachets (42) – cardboard packs.
2.2 g – sachets (49) – cardboard packs.
2.2 g – sachets (50) – cardboard packs.

Elbona^® [Ellara, LLC (Russia)]
Solution for intramuscular and intra-articular administration 200 mg/1 ml: amp. 2 ml 6 or 12 pcs. with solvent

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Elbona^®

Solution for intramuscular and intra-articular administration 200 mg/1 ml: amp. 2 ml 6 or 12 pcs. with solvent

Dosage Form, Packaging, and Composition

Solution for intramuscular administration (solution A) colorless or light yellow, transparent; supplied solvent (solution B) – colorless, transparent; prepared solution (solution A + solution B) light yellow, transparent.

	1 ml	1 amp.
Glucosamine sulfate sodium chloride	201.25 mg	502.5 mg,
Equivalent to glucosamine sulfate content	200 mg	400 mg
Sodium chloride	51.25 mg	102.5 mg

Excipients : trometamol (tromethamine) – to pH 2.0-3.0, lidocaine hydrochloride – 10 mg, water for injections – up to 2 ml.

Solvent (solution B) diethanolamine – 24 mg, water for injections – 1 ml (ampoules).

2 ml – dark glass ampoules (6) – contour cell packs (1), supplied with solvent (amp. 6 pcs.) – contour cell packs (1) – cardboard packs.
2 ml – dark glass ampoules (6) – contour cell packs (2), supplied with solvent (amp. 6 pcs.) – contour cell packs (2) – cardboard packs.
2 ml – dark glass ampoules (6) supplied with solvent (amp. 6 pcs.) – contour cell packs (1) – cardboard packs.
2 ml – dark glass ampoules (12) – contour cell packs (1), supplied with solvent (amp. 12 pcs.) – contour cell packs (1) – cardboard packs.