INSTRUCTION

for medical use of a medicinal product

ALFLUTOP (ALFLUTOP^®)

Composition: active ingredient: 1 ml 0.1 ml 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, the main composition of which, in addition to nitrogen or sulfur, includes glycerol and phosphorus); excipients: phenol, water for injections.

Dosage formSolution for injection.

Main physicochemical properties: clear solution without suspended particles.

Pharmacological group. Means used in pathologies of the musculoskeletal system. ATX code M09A X.

Pharmacological properties. 

Pharmacodynamics.

The drug regulates metabolism in cartilage tissue.

It has a chondroprotective effect by normalizing the biosynthesis of hyaluronic acid and type II collagen and inhibiting the activity of hyaluronidase and other enzymes involved in the destruction of the intercellular matrix. These effects lead to the activation of cartilage structure restoration processes and prevent the destruction of macromolecular structures of normal cartilage tissue.

Restoring homeostasis in the joint, the drug inhibits the biosynthesis of inflammatory mediators, including pro-inflammatory cytokines. As a result, the drug has a pronounced anti-inflammatory and analgesic effect, which manifests itself on the 8th-10th day of treatment.

The proteoglycans that make up the drug have a trophic effect and a replacement effect, significantly increasing MRI indicators of hydrophilicity, cartilage height, and bone tissue homogeneity.

Pharmacokinetics.

The effect of the extract of marine organisms is the combined effect of its active components, therefore, studying the pharmacokinetic characteristics is impossible.

Clinical characteristics.

Indication.

Degenerative-rheumatic diseases of the joints:

– osteoarthritis of various localization (coxarthrosis, gonarthrosis, arthrosis of small joints);

– spondylosis.

Recovery period after injuries and surgeries on the joints.

Contraindication.

Contraindicated in case of hypersensitivity to the components of the drug.

Interaction with other drugs and other types of interactions.

When using Alflutop simultaneously with local anesthetic drugs, primarily PABA derivatives (novocaine), one should be aware of the side effects of the latter.

Application features.

The drug should be used with caution under strict medical supervision, especially in cases of autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, lupus erythematosus, scleroderma). The drug may cause anaphylactic reactions. It should be prescribed with caution to persons with a history of severe allergies.

Use during pregnancy or breastfeeding.

Do not prescribe to pregnant women or during breastfeeding.

The ability to influence the reaction speed when driving vehicles or other mechanisms.

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

Method of administration and doses.

The drug is prescribed for adults.

Alflutop is administered deeply intramuscularly. Usually, 1 ml should be administered once a day, the course of treatment is 20 days.

In case of damage to large joints, the drug is administered intra-articularly in 1-2 ml doses with an interval of 3 days between injections. The course of treatment is 5 injections into each joint.

According to medical indications, the course of treatment should be repeated after 3-6 months.

Children.

Do not prescribe the drug to children due to the lack of clinical data confirming the safety and effectiveness of its use in this age group.

Overdose.

Some patients may experience allergic reactions.

Adverse reactions.

Rare: changes at the injection site, including burning at the injection site, redness of the skin.

In isolated cases: transient increase in pain syndrome (with intra-articular administration due to activation of metabolism and intensification of blood circulation), short-term myalgia. There are also cases of hypersensitivity reactions, including rash, dermatitis, urticaria, itching, angioedema, anaphylactic shock.

The term of dignity.

3 years.

Storage conditions.

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

Incompatibility.

There is no data on the incompatibility of Alflutop with other drugs, therefore Alflutop should not be mixed with any solutions in the same syringe.

Packaging.

1 ml of solution in glass ampoules. 10 ampoules together with instructions for use in a cardboard box.

Vacation category.

According to the recipe.

Producer.

KO "Biotechnos" A.T.

Location of the manufacturer and address of its place of business.

Str. Gorunului nr. 3-5, Oras Otopeni, Jud. Ilfov, cod 075100, Romania.