Alflutop

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ALFLUTOP® (ALFLUTOP®)

Composition:

Active substance: 1 ml of solution contains 0.1 ml of bioactive concentrate from small marine fish (dry matter: chondroitin sulfate, amino acids, sugars, myoinositol, salts of Na, K, Ca, Mg, Cu, Fe, Mn, Zn; compounds of the glycerophospholipid group, whose main components, besides nitrogen or sulfur, include glycerol and phosphorus);

Excipients: phenol, water for injections.

Pharmaceutical form. Solution for injection.

Main physicochemical properties: clear solution without suspended particles.

Pharmacotherapeutic group. Agents used in disorders of the musculoskeletal system. ATC code M09AX.

Pharmacological properties.

Pharmacodynamics.

The drug regulates metabolism in cartilage tissue.

It exerts a chondroprotective effect by normalizing the biosynthesis of hyaluronic acid and type II collagen, and by inhibiting the activity of hyaluronidase and other enzymes involved in the degradation of the extracellular matrix. These effects promote the activation of processes responsible for the restoration of cartilage structure and prevent the destruction of macromolecular structures of normal cartilaginous tissue.

By restoring joint homeostasis, the drug inhibits the biosynthesis of inflammatory mediators, including pro-inflammatory cytokines. As a result, the drug produces a pronounced anti-inflammatory and analgesic effect, which becomes evident on day 8–10 of treatment.

Proteoglycans contained in the drug have a trophic effect and a replacement function, significantly improving MRI parameters of cartilage hydrophilicity, cartilage height, and bone tissue homogeneity.

Pharmacokinetics.

The action of the marine organism extract is a combined effect of its active components; therefore, studying its pharmacokinetic characteristics is not feasible.

Clinical characteristics.

Indications.

Degenerative rheumatic joint diseases:

• osteoarthritis of various localizations (coxarthrosis, gonarthrosis, small joint arthrosis);
• spondylosis.

Recovery period following joint injuries and surgical interventions.

Contraindications.

Contraindicated in patients with hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

When using Alflutop simultaneously with local anesthetics, particularly derivatives of para-aminobenzoic acid (e.g., novocaine), the adverse effects of the latter should be taken into account.

Special precautions for use.

The drug should be administered with caution under strict medical supervision, especially in patients with autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, scleroderma). The drug may cause anaphylactic reactions. Use with caution in individuals with a history of allergies.

Use during pregnancy or breastfeeding.

Do not administer during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

The drug does not affect the ability to drive a vehicle or operate complex machinery.

Dosage and Administration.

The medication is intended for use in adults.

Administer Alflutop by deep intramuscular injection. The usual dose is 1 ml once daily; treatment course lasts 20 days.

In case of large joint involvement, administer the drug intra-articularly at a dose of 1–2 ml with an interval of 3 days between injections. Treatment course consists of 5 injections into each joint.

If medically indicated, the treatment course may be repeated after 3–6 months.

Children.

Do not administer the medication to children due to lack of clinical data confirming its safety and efficacy in this age group.

Overdose.

In some patients, allergic reactions may occur.

Side effects.

Rare: reactions at the injection site, including burning sensation at the injection site, skin redness.

In isolated cases: transient exacerbation of pain (following intra-articular administration due to activation of metabolism and increased blood circulation), short-term myalgia. Hypersensitivity reactions have also been reported, including rash, dermatitis, urticaria, pruritus, angioneurotic edema, anaphylactic shock.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C, in the original packaging to protect from light.

Incompatibility.

There are no data on incompatibility of Alflutop with other medicinal products; therefore, Alflutop must not be mixed with any other solutions in the same syringe.

Packaging.

1 ml of solution in glass ampoules; 5 ampoules in a blister pack; 2 blister packs together with the instructions for medical use in a cardboard box.

1 ml of solution in glass ampoules; 5 ampoules in a blister pack with foil; 2 blister packs together with the instructions for medical use in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

"Biotehnos" JSC.

Manufacturer's address and location of operations.

Str. Gorunului, nr. 3-5, Loc. Otopeni, Oras Otopeni, Judet Ilfov, cod postal 075100, Romania.