Ambene^® Bio (Solution) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Deko Company, LLC (Russia)

Or

Biokhimik, JSC (Russia)

Contact Information

PROMOMED RUS LLC (Russia)

ATC Code

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

Dosage Form

Ambene® Bio

Solution for injection 0.1 g/1 ml: 1 ml or 2 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection colorless or from light yellow to light brownish-yellow.

Excipients : phenol – up to 0.005 g/ml, water for injection – up to 1 ml.

1 ml – ampoules of light-protective glass (5) – contour cell packs made of polyvinyl chloride film (1) complete with an ampoule knife, scarifier or without – cardboard boxes.
1 ml – ampoules of light-protective glass (5) – contour cell packs made of polyvinyl chloride film (2) complete with an ampoule knife, scarifier or without – cardboard boxes.
2 ml – ampoules of light-protective glass (5) – contour cell packs made of polyvinyl chloride film (1) complete with an ampoule knife, scarifier or without – cardboard boxes.
2 ml – ampoules of light-protective glass (5) – contour cell packs made of polyvinyl chloride film (2) complete with an ampoule knife, scarifier or without – cardboard boxes.

Clinical-Pharmacological Group

Tissue repair stimulant of natural origin

Pharmacotherapeutic Group

Tissue repair stimulant of natural origin

Pharmacological Action

Ambene^® Bio is a chondroprotector, the active component of which is a bioactive extract from small marine fish.

The extract contains mucopolysaccharides (chondroitin sulfate), amino acids, peptides, and ions of sodium, potassium, calcium, magnesium, iron, copper, and zinc.

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

The anti-inflammatory effect and tissue regeneration are based on the inhibition of hyaluronidase activity and the normalization of hyaluronic acid biosynthesis.

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

Indications

In adults

• Primary and secondary osteoarthrosis of various locations (coxarthrosis, gonarthrosis, arthrosis of small joints);
• Osteochondrosis;
• Spondylosis.

ICD codes

Dosage Regimen

For polyosteoarthrosis and osteochondrosis, the drug is administered deep intramuscularly

• 1 ml/day, the course of treatment is 20 injections (1 injection per day for 20 days)

Or

• 2 ml every other day, the course of treatment is 10 injections (1 injection every other day for 20 days).

For predominant involvement of large joints, the drug is administered intra-articularly, 1-2 ml into each joint with an interval of 3-4 days. A total of 5-6 injections per joint per course.

A combination of intra-articular and intramuscular administration methods is possible.

It is advisable to repeat the course of treatment after 6 months following consultation with a doctor.

Adverse Reactions

The frequency of adverse reactions listed below was determined according to the following gradation: very common (>1/10), common (>1/100, ≤1/10), uncommon (>1/1000, ≤1/100), rare (>1/10000, ≤1/1000), very rare (≤1/10000).

Allergic reactions : rare – itching; very rare – anaphylactic reactions.

Local reactions rare – skin redness and burning sensation at the injection site.

Other short-term myalgia. In some cases, with intra-articular injections, a transient increase in pain syndrome is possible.

Contraindications

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

Use in Pregnancy and Lactation

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

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

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

Effect on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator).

Overdose

In case of overdose, dose-dependent undesirable drug reactions are intensified.

Drug Interactions

None identified to date.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F) in the secondary packaging (box).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.