Actovegin 80 mg Injection, 2 ml (25 Ampoules)

Actovegin 80 mg Injection, 2 ml (25 Ampoules)

Actovegin 80 mg is a parenteral dosage form supplied as a solution for injection in 2 ml ampoules.
The active substance is a deproteinized hemoderivative obtained from calf blood. This injectable
form is used in clinical practice when parenteral administration in smaller single-dose volumes
is considered appropriate by a healthcare professional.

This informational leaflet provides a structured medical overview of Actovegin 80 mg (2 ml ampoules),
including pharmaceutical characteristics, pharmacological properties, clinical use, administration
principles, safety considerations, and storage requirements.

Pharmaceutical Form and Strength

• Dosage form: Solution for injection
• Strength per ampoule: 80 mg
• Ampoule volume: 2 ml
• Concentration: 40 mg/ml
• Pack size: 25 ampoules
• Active substance: Deproteinized hemoderivative from calf blood

The active substance is produced through multistage filtration processes aimed at removing
high-molecular proteins, resulting in a complex of low-molecular components. The exact composition
of excipients may vary depending on registration and manufacturer; reference should always be made
to the package leaflet supplied with the product.

Pharmacological Properties

Actovegin is classified as a metabolic medicinal product with antihypoxic properties.
Its pharmacological activity is associated with enhanced cellular utilization of oxygen and glucose,
supporting energy metabolism in tissues affected by impaired circulation or hypoxic conditions.

Due to the biological origin of the active substance, the mechanism of action is considered
multifactorial and is described in medical literature as a combined metabolic and microcirculatory
support effect rather than a single-target mechanism.

Indications for Use

According to official product documentation, injectable Actovegin is used in treatment protocols
for conditions associated with impaired circulation and tissue trophism when parenteral therapy
is prescribed by a clinician. Commonly listed indications include:

• Cerebral circulatory and metabolic disorders
• Peripheral circulation disorders and trophic disturbances
• Diabetic polyneuropathy (in selected therapeutic regimens)

The 2 ml ampoule format is commonly used when lower single-dose volumes or gradual dose titration
are clinically indicated.

Route of Administration

Actovegin 80 mg (2 ml) is intended for parenteral administration.
Depending on the prescribing plan and local instructions, administration may include:

• Intramuscular (IM) injection
• Intravenous (IV) injection (slow administration under medical supervision)

Parenteral administration must be carried out by qualified medical personnel.
Medical supervision is particularly important at the beginning of therapy due to the risk
of hypersensitivity reactions.

Dosage Principles

Dosage and duration of therapy are determined individually by a healthcare professional.
General clinical practice principles include:

• Initiation of therapy under medical supervision
• Adjustment of dose and route based on diagnosis, severity, and patient response
• Possible transition to higher-volume ampoules or oral Actovegin tablets as continuation therapy,
  depending on the clinical scenario

Patients should not change the dose, frequency, or route of administration independently.

Contraindications

Actovegin injection solutions should not be used in patients with known hypersensitivity
to the active substance or any excipients contained in the formulation.

Because contraindications and precautions may vary depending on local registration,
the package leaflet for the specific product batch should be considered the primary reference.

Warnings and Precautions

• Hypersensitivity reactions: Allergic reactions may occur and require immediate discontinuation.
• Comorbid conditions: Inform the clinician of any cardiac, renal, pulmonary, or metabolic disorders.
• Medical supervision: Parenteral administration should be performed in a setting equipped to manage acute reactions.

If symptoms such as rash, itching, facial swelling, breathing difficulty, or sudden weakness occur,
administration must be stopped and emergency medical care sought.

Use During Pregnancy and Breastfeeding

Use of Actovegin during pregnancy or breastfeeding should only take place under medical supervision
and after an individualized assessment of potential benefits and risks.

Possible Side Effects

As with all medicinal products, Actovegin may cause adverse reactions. The most clinically relevant
concern with injectable formulations is hypersensitivity. Reported reactions may include:

• Allergic skin reactions (rash, itching, urticaria)
• Flushing or sensation of warmth
• Rarely, severe hypersensitivity reactions such as angioedema or anaphylactoid responses
• Local injection-site reactions (pain, redness)

Any suspected adverse reaction should be reported to a healthcare professional.
Severe reactions require immediate medical attention.

Drug Interactions

Patients should inform their healthcare provider of all medicines and supplements being used.
Although specific interaction patterns are not emphasized in standard documentation,
clinical review of concomitant therapy is recommended.

Storage and Handling

• Store ampoules according to the temperature and light-protection instructions on the packaging
• Do not use the solution if it appears discolored or contains visible particles
• Single-use only: An opened ampoule must not be reused
• Keep out of the reach of children

Clinical Use Considerations

The 80 mg (2 ml) ampoule format is frequently used in clinical practice when smaller injection volumes
are preferred, such as during gradual initiation of therapy or in protocols requiring repeated
low-volume administrations. Treatment decisions are based on diagnosis, patient condition,
and therapeutic goals defined by a clinician.

Summary

Actovegin 80 mg injection solution in 2 ml ampoules is a parenteral formulation used in clinical practice
to support metabolic processes and tissue trophism in conditions associated with impaired circulation.
Administration should be performed under professional supervision, with attention to hypersensitivity
risk, comorbidities, and local prescribing guidance.