Eltuflop^® Bio (Solution) Instructions for Use

Marketing Authorization Holder

Ellara, LLC (Russia)

ATC Code

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

Dosage Form

Eltuflop® Bio

Solution for injection: amp. 1 ml or 2 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, from light yellow to brown in color with a characteristic odor.

* bioactive extract from small marine fish [European sprat ( Sprattus sprattus ) of the herring family, Black Sea whiting ( Odontogadus merlangus euxinus ) of the cod family, Black Sea shad ( Alosa tanaica ) of the herring family, European anchovy ( Engraulis encrassicholus ) of the anchovy family], obtained by extraction followed by deproteinization and delipidization.

Excipients : phenol – up to 5 mg, water for injection – up to 1 ml.

1 ml – ampoules of neutral light-protective glass (5) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules of neutral light-protective glass (5) – contour cell packaging (2) – cardboard packs.
2 ml – ampoules of neutral light-protective glass (5) – contour cell packaging (1) – cardboard packs.
2 ml – ampoules of neutral light-protective glass (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Tissue repair stimulant of natural origin

Pharmacotherapeutic Group

Tissue repair stimulant of natural origin

Pharmacological Action

Chondroprotector. The bioactive concentrate from small marine fish contains mucopolysaccharides (chondroitin sulfate), amino acids, peptides, ions of sodium, potassium, calcium, magnesium, iron, copper, and zinc.

It prevents the destruction of the macromolecular structures of normal tissues and stimulates recovery processes in the interstitial tissue and articular cartilage tissue, which explains its analgesic effect.

The anti-inflammatory effect and tissue regeneration are based on the inhibition of hyaluronidase activity and the normalization of hyaluronic acid biosynthesis.

Both these effects are synergistic and cause the activation of restorative processes in tissues, in particular, the restoration of cartilage structure.

Indications

Primary and secondary osteoarthritis of various locations (coxarthrosis, gonarthrosis, arthrosis of small joints); spondylosis; osteochondrosis.

ICD codes

Dosage Regimen

Administer intramuscularly or intra-articularly.

For intramuscular administration, inject deeply into the upper outer quadrant of the gluteal muscle.

For intra-articular administration, adhere to strict aseptic technique.

The standard adult dose is 1 ml to 2 ml per injection.

For osteoarthritis and spondylosis, administer 1 ml intramuscularly every other day.

The base course consists of 25 injections.

For intra-articular administration in large joints (e.g., knee, hip), inject 1-2 ml.

For medium-sized joints, administer 0.5-1 ml.

For small joints, inject 0.1-0.2 ml.

Inject intra-articularly at intervals of 3-4 days.

A typical intra-articular course consists of 5-6 injections per affected joint.

Repeat treatment courses after 4-6 months based on clinical indications and physician assessment.

Do not exceed the recommended single or course dosage.

Adjust the regimen based on disease severity and individual patient response.

Adverse Reactions

Rarely pruritic dermatitis, skin redness, burning sensation at the injection site, short-term myalgias.

Very rarely anaphylactic reactions.

Frequency unknown transient increase in pain syndrome (with intra-articular administration).

Contraindications

Hypersensitivity to the active substance; pregnancy, breastfeeding period; age under 18 years.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated under 18 years of age (due to the lack of clinical data in this category of patients).

Special Precautions

In case of individual intolerance to seafood (marine fish), the risk of developing allergic reactions increases.

Storage Conditions

Store at 15°C (59°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.