Actovegin 40 mg/ml Injection, 10 ml (5 Ampoules)

Actovegin 40 mg/ml Injection, 10 ml (5 Ampoules)

Actovegin 40 mg/ml is a parenteral dosage form supplied as a solution for injection/infusion in 10 ml ampoules.
The active substance is a deproteinized hemoderivative obtained from calf blood. The injectable form is used in
clinical practice when a physician considers parenteral administration appropriate, including situations where a faster
onset of action or controlled dosing is required.

This informational leaflet provides a structured overview of Actovegin 40 mg/ml (10 ml ampoules), including pharmaceutical
characteristics, clinical use, administration principles, safety considerations, and storage guidance.

Pharmaceutical Form and Composition

• Dosage form: Solution for injection and/or infusion (market-dependent labeling)
• Strength: 40 mg/ml
• Ampoule size: 10 ml
• Pack size: 5 ampoules
• Active substance: Deproteinized hemoderivative from calf blood

The active substance is obtained through multistage filtration designed to remove high-molecular proteins,
resulting in a complex mixture of low-molecular components. Excipients vary by registration and manufacturer batch;
always consult the package leaflet for the exact composition.

Pharmacological Properties

Actovegin is described as a metabolic agent with antihypoxic properties. The proposed pharmacological effects
are linked to enhanced cellular utilization of oxygen and glucose, supporting energy metabolism in tissues exposed
to compromised circulation or hypoxic stress.

Because the active substance is biological-derived and multifactorial, the mechanism is commonly presented as a combined
metabolic and microcirculatory support effect rather than a single-target pharmacological action.

Indications for Use

Indications may differ slightly across countries and official product documentation. In clinical labeling, injectable Actovegin
is used in the context of metabolic and vascular disorders where parenteral therapy is prescribed by a clinician. Commonly listed
indications include:

• Cerebral circulatory and metabolic disorders (e.g., post-stroke recovery phases, traumatic brain injury sequelae)
• Peripheral circulation disorders and related trophic disturbances
• Diabetic polyneuropathy (in certain treatment protocols)

The 10 ml ampoule format is typically selected when a higher single-dose volume is required within a prescribed regimen.
The decision to use injections/infusions and to select dose/volume is made by a healthcare professional based on diagnosis,
severity, comorbidities, and treatment goals.

Route of Administration and Practical Notes

Actovegin 40 mg/ml (10 ml) is intended for parenteral use. Depending on the prescribing plan and local leaflet,
administration may involve:

• Intravenous (IV) injection (slow administration under professional supervision)
• Intravenous (IV) infusion after appropriate dilution (as specified by local instructions)
• Intramuscular (IM) injection (in selected cases and volumes consistent with clinical guidance)

Parenteral therapy should be performed by qualified medical personnel. For injectable biological-derived preparations,
clinicians commonly apply heightened vigilance for hypersensitivity reactions, particularly at treatment initiation.

Dosage Principles

Dosage and treatment duration are determined individually by a healthcare professional and can vary depending on the indication
and severity. General clinical practice principles typically include:

• Start of therapy under medical supervision, with monitoring for hypersensitivity
• Use of IV infusion/injection in acute or intensive phases when prescribed
• Possible transition to oral Actovegin tablets as continuation therapy when clinically appropriate

Patients should not attempt self-administration unless explicitly instructed and trained by a clinician, and should not change
dose or schedule independently.

Contraindications

Actovegin injection/infusion solutions should not be used in patients with:

• Known hypersensitivity to Actovegin or any excipients
• Conditions associated with severe fluid overload where parenteral volume may be clinically inappropriate (assessment by clinician required)

Because contraindications and warnings can be formulation- and jurisdiction-dependent, the package leaflet for the specific product
batch should be considered the primary reference.

Warnings and Precautions

• Hypersensitivity risk: Allergic reactions are possible. Medical supervision is advised at initiation and during administration.
• Fluid and electrolyte status: In patients with fluid retention or electrolyte imbalance, clinicians may require additional monitoring.
• Comorbidities: Inform the clinician about cardiac, renal, or pulmonary conditions and all ongoing therapies.

If signs of hypersensitivity occur (rash, urticaria, facial swelling, wheezing, sudden weakness, hypotension), administration
must be stopped and emergency medical management initiated.

Use During Pregnancy and Breastfeeding

Use during pregnancy or breastfeeding should only occur under medical supervision and after an individualized benefit–risk assessment.
Parenteral therapy in these settings requires particular caution and should follow local prescribing guidance.

Possible Side Effects

Adverse reactions can occur with any medicinal product. For injectable Actovegin, the most clinically significant concern is
hypersensitivity. Potential adverse effects include:

• Allergic skin reactions (rash, itching, urticaria)
• Flushing, sensation of warmth
• Rarely, severe hypersensitivity reactions including angioedema or anaphylactoid reactions
• Local injection-site reactions (pain, redness) depending on route

Any suspected adverse reaction should be reported to a healthcare professional. Severe or rapidly progressive symptoms
require urgent medical attention.

Drug Interactions

Patients should inform the clinician of all medicines and supplements in use. Specific interaction patterns are not typically
highlighted in standard patient leaflets, but safe clinical practice requires review of concomitant therapy, especially in complex
neurological or vascular treatment plans.

Storage and Handling

• Store ampoules according to the temperature and light-protection instructions printed on the packaging
• Do not freeze unless explicitly stated in local documentation
• Inspect the solution before use; do not use if particles, discoloration, or damaged ampoules are present
• Single-use only: An opened ampoule must not be stored for later use
• Keep out of the reach of children

Clinical Use Considerations

The injectable/infusion form is frequently used in structured regimens where parenteral administration is required, for example
during acute or intensive phases of therapy, followed by oral continuation with tablets in outpatient settings when appropriate.
The treatment plan, including total dose, route, and duration, depends on the patient’s diagnosis and clinical response.

Summary

Actovegin 40 mg/ml injection/infusion solution in 10 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 the prescribing plan.