What is ALFLUTOP®?
ALFLUTOP® is a medicinal product designed to support the musculoskeletal system. It is a solution for injection, specifically formulated to treat various conditions affecting joints and cartilage. Each ampoule contains 10 mg of bioactive concentrate derived from small marine fish.
What are the indications for ALFLUTOP®?
ALFLUTOP® is primarily used in adults to manage:
- Primary and secondary osteoarthritis of various locations, including coxarthrosis, gonarthrosis, and small joint arthritis.
- Osteochondrosis.
- Spondylosis.
What should be considered before starting ALFLUTOP®?
Contraindications
ALFLUTOP® should not be used in individuals with:
- Hypersensitivity to any component of the medication.
- Pregnancy and breastfeeding.
- Children and adolescents under 18 years old.
Drug Interactions
No significant interactions with other medications have been identified.
Special Warnings
- Use with caution in patients with autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, lupus erythematosus, and scleroderma. These patients require strict medical supervision.
- Individuals with a known intolerance to seafood (marine fish) may have an increased risk of allergic reactions.
Use in Pediatrics
ALFLUTOP® is contraindicated for use in children.
Use During Pregnancy and Lactation
The use of ALFLUTOP® is contraindicated during pregnancy and lactation.
Effect on Ability to Drive and Use Machinery
ALFLUTOP® does not affect the ability to drive or operate potentially dangerous machinery.
How should ALFLUTOP® be used?
Dosage Regimen
For adults:
- Osteoarthritis and Osteochondrosis: Administer 1 ml deep intramuscularly daily for 20 days (20 injections) or 2 ml every other day for a total of 10 injections over 20 days.
- Large Joint Involvement: Administer 1-2 ml intra-articularly into each affected joint every 3 days, under medical supervision. A total of 5 injections per joint are recommended.
Combination of intra-articular and intramuscular administration methods is possible. A repeat treatment course may be considered after six months, upon consultation with a healthcare provider.
Method and Route of Administration
ALFLUTOP® is administered via intramuscular or intra-articular injection.
Measures to Take in Case of Overdose
Symptoms of overdose may include allergic reactions in predisposed patients. Treatment involves discontinuation of the medication and symptomatic therapy.
Consultation with a Healthcare Professional
Always consult a healthcare professional before starting any new medication to ensure proper usage and to address any concerns.
What are the possible side effects of ALFLUTOP®?
Common Side Effects
- Itchy dermatitis, skin redness, and a burning sensation at the injection site.
- Short-term myalgias (muscle pain).
- Increased blood pressure.
Rare Side Effects
- Anaphylactic reactions (very rare).
- Transient pain exacerbation after intra-articular injections (frequency unknown).
What is the composition of ALFLUTOP®?
Bioactive Concentrate from Fish
ALFLUTOP® contains an extract obtained from small marine fish, including species like sprat, anchovy, and whiting. The bioactive concentrate is derived through a complex process that includes extraction, protein precipitation, delipidization, and sterilization.
The fish extract contains:
- Mucopolysaccharides: These are long chains of sugar molecules found in the body, particularly in the connective tissues.
- Amino Acids: ALFLUTOP® contains amino acids such as glycine, proline, and lysine, which are essential for protein synthesis and joint repair.
- Peptides: These are short chains of amino acids that play a crucial role in various biological functions, including tissue repair.
- Mineral Salts: The extract includes essential minerals like calcium, potassium, sodium, magnesium, zinc, iron, and copper, which are vital for bone and joint health.
- Hyaluronic Acid: This is a substance naturally found in the body that helps in maintaining the viscosity and elasticity of synovial fluid in the joints.
Phenol
ALFLUTOP® contains phenol as a preservative. Phenol is used to maintain the sterility and stability of the solution. The concentration of phenol in the medication is very low and within safe limits.
Sodium Chloride (NaCl)
Commonly known as table salt, sodium chloride is used to adjust the tonicity of the solution, making it isotonic with body fluids to ensure compatibility and minimize discomfort during injection.
Additional Information
Appearance, Smell, and Taste
ALFLUTOP® is a clear solution ranging from light yellow to light brown in color.
Packaging
The solution is supplied in 1 ml amber glass ampoules. Each pack contains 10 ampoules, arranged in polyethylene cell packs and covered with aluminum foil,
Storage Conditions
Store in a place protected from light, at temperatures between 15°C and 25°C (59°F to 77°F). Keep out of reach of children. Do not use after the expiration date.
