Instructions Alflutop solution for injection ampoule 1% 1 ml No. 10
Composition
active ingredient: 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, the main composition of which, in addition to nitrogen or sulfur, includes glycerol and phosphorus);
excipients: phenol, water for injection.
Dosage form
Solution for injection.
Main physicochemical properties: clear solution without suspended particles.
Pharmacotherapeutic 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 preparation 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.
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 any component of the drug.
Interaction with other medicinal products and other types of interactions
When using Alflutop simultaneously with local anesthetics, primarily derivatives of para-aminobenzoic acid (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.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive a car or operate complex mechanisms.
Method of administration and doses
The drug is prescribed for adults.
Alflutop is administered deeply intramuscularly. Usually, 1 ml is prescribed 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 a burning sensation at the injection site, skin redness.
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.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° 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; 5 ampoules in a blister pack; 2 blister packs together with instructions for medical use in a cardboard box.
1 ml of solution in glass ampoules; 5 ampoules in a foil blister pack; 2 blister packs together with instructions for medical use in a cardboard box.
Vacation category
According to the recipe.
Producer
"Biotechnos" JSC.
Str. Gorunului nr. 3-5, Oras Otopeni, Jud. Ilfov, cod 075100, Romania.
