Package
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Indications of the drug

Alflutop^® is used in adults with primary and secondary osteoarthritis of different localization (coxarthrosis, gonarthrosis, arthrosis of small joints), osteochondrosis and spondylosis.

Method of administration and dosage

In polyosteoarthritis and osteochondrosis

1 ml #20 daily: 2 packs of 1 ml #10

2 ml #10 every other day: 1 pack of 2 ml #10

The drug is administered deeply intramuscularly

In case of predominant lesions of large joints

1-2 ml in each joint with an interval of 3-4 days: 5-6 injections per course

The drug is administered intra-articularly

It is possible to combine
intra-articular and intramuscular
methods of administration

2 courses
per year

Remission
up to 6 months

Drug form, packaging

Solution for injection.

1 ml or 2 ml in dark glass ampoules with a white break ring. Each ampoule is labeled

5 ampoules in cellular polymer packaging with aluminum foil coating

2 cell packs (1 ml or 2 ml ampoules) or 1 cell pack (2 ml ampoules) together with instructions for use in a cardboard pack

2 ml

Convenient for i/a regimen

1 ml

Convenient for i/m regimen

2 ml

One package per course

Contraindications to use

Hypersensitivity to the components of the drug. Pregnancy
and breastfeeding period. Children under 18 years of age
(due to the lack of clinical data in this category of patients)

Use in pregnancy and breast-feeding

The use of the drug is contraindicated in pregnancy
and during breastfeeding

Side effects

Side effects are grouped according to the WHO adverse reaction frequency classification: very frequent (≥1/10), frequent (≥1/100 to ≥1/10), infrequent (≥1/1000 to ≥1/100), rare (≥1/10000 to ≥1/1000), very rare (≥1/10000), frequency unknown (frequency cannot be determined on the basis of available data)

Rare: pruritus, skin redness, burning sensation at the site of drug administration, transient myalgias

Very rare: anaphylactic reactions

Frequency unknown: transient worsening of pain syndrome (when administered intra-articularly)

Special instructions

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

Effect on the ability to drive vehicles and mechanisms

Administration of the drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (driving vehicles, working with moving mechanisms, work of dispatcher and operator).

Overdose

Dose-dependent undesirable drug reactions increase in case of overdose

Drug interaction

So far, drug interaction of Alflutop^® has not been revealed

Pharmacological action

Alflutop^® is a chondroprotector, the active component of which is a bioactive concentrate from small marine fish. The concentrate contains mucopolysaccharides (chondroitin sulfate), amino acids, peptides, sodium, potassium, calcium, magnesium, iron, copper and zinc ions.

Alflutop^® prevents the destruction of macromolecular structures of normal tissues, stimulates repair processes in the interstitial tissue and articular cartilage tissue, which explains its analgesic effect

Anti-inflammatory action and tissue regeneration are based on inhibition of hyaluronidase activity and normalization of hyaluronic acid biosynthesis

Both of these effects are synergistic and cause the activation of regenerative processes in tissues (in particular, the restoration of cartilage structure)

General information

Trade name:

ALFLUTOP^®

ATX code:

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

Registration Number:

П N012210/0

Pharmacotherapeutic group:

Tissue repair stimulator of natural origin

Dosage form

Solution for injection

The active component of the preparation is a bioactive concentrate from small marine fishes: Sprattus sprattus sprattus sprattus, family Clupeidae; Odontogadus merlangus euxinus, family Gadidae; Alosa tanaica nordmanni, family Clupeidae; Engraulis encrasicholus ponticus, family Engraulidae, obtained by extraction with subsequent deproteinization and delipidization

Composition of the preparation per 1 ml:

Active substance:
bioactive concentrate of small marine fishes 0.1 ml

Auxiliary substances:
phenol not more than 0.005 g
water for injection up to 1 ml

Description

Colorless or slightly brownish-yellow or slightly yellow, transparent liquid.

Storage Conditions

In a place protected from light at temperatures from 15 ° C to 25 ° C. Keep out of reach of children

Shelf life

3 years. Do not use the drug with expired expiration date.

Conditions of dispensing

By prescription

Manufacturer

Legal entity in whose name the registration certificate is issued

K.O. Biotehnos S.A. Gorunului str. no. 3-5, Otopeni town, Ilfov county, 075100, Romania

Manufacturer and primary packaging

S.C. ZENTIVA S.A. Teodor Palladi Boulevard No. 50, District 3, Bucharest, 032266, Romania

Secondary packaging and release quality control