Rumalon^® (Solution) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

M09AX (Other drugs for the treatment of musculoskeletal system diseases)

Active Substance

Glycosaminoglycan peptide complex

Dosage Form

Rumalon®

Solution for intramuscular administration: amp. 1 ml 10 or 25 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular administration from pale yellow with a brownish tint to yellowish-brown in color, transparent, with the smell of metacresol.

Dark glass ampoules (5) – contour cell packs (2) – cardboard boxes.
Dark glass ampoules (5) – contour cell packs (5) – cardboard boxes.

Clinical-Pharmacological Group

Tissue repair stimulant

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

A substance of animal origin. It normalizes metabolism in hyaline cartilage tissue: enhances the biosynthesis of sulfated mucopolysaccharides and collagen, stimulates the regeneration of articular cartilage, reduces enzyme activity and inhibits catabolic processes in cartilage tissue.

Indications

• Degenerative-dystrophic joint diseases: gonarthrosis; arthrosis of the interphalangeal joints; coxarthrosis; spondylosis; spondyloarthrosis; meniscopathy; chondromalacia patellae.

ICD codes

Dosage Regimen

Administer deep intramuscularly according to the established regimen.

The standard course consists of 25 injections administered twice a year. Initiate therapy with a dose of 0.3 ml on the first day.

Increase the dose to 0.5 ml on the second day and to 1.0 ml on the third day. Continue administration with a dose of 1.0 ml three times a week.

Follow the specific regimen prescribed by the physician.

Adverse Reactions

Immune system disorders: rarely – allergic reactions, including skin rash, pruritus, urticaria; very rarely – anaphylactoid reactions, anaphylactic shock.

Nervous system disorders: rarely – dizziness, headache.

Gastrointestinal disorders: rarely – nausea.

General disorders and administration site conditions: rarely – pain at the injection site.

Discontinue use immediately if signs of a severe allergic reaction appear.

Contraindications

• Rheumatoid arthritis.
• Age under 18 years.
• Pregnancy and breastfeeding period.
• Use in women of reproductive age not using reliable contraceptive methods.
• Hypersensitivity to the active substance or any of the excipients.
• History of severe allergic reactions to products of animal origin.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

With simultaneous use with indirect anticoagulants, antiplatelet agents and fibrinolytics, frequent monitoring of blood coagulation parameters is necessary.

Drug Interactions

With simultaneous use with indirect anticoagulants, antiplatelet agents and fibrinolytics, their effect may be enhanced.

This may increase the risk of bleeding. Monitor coagulation parameters closely during concomitant therapy.

Inform your physician about all medications you are taking before starting treatment.

Overdose

No cases of overdose have been reported. In case of suspected overdose, discontinue administration immediately.

Initiate symptomatic and supportive treatment. There is no specific antidote.

Monitor the patient for signs of allergic reactions or other adverse effects.

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

Rx Only

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.