ACTOVEGIN ampoules 400 mg, 10 ml, #5

Description

ACTOVEGIN Ampoules 400 mg, 10 ml, #5

Composition

• Each 10 ml ampoule contains 400 mg of Actovegin (calf blood deproteinized hemoderivative, calculated as dry weight).
• Other ingredients: sodium chloride and water for injections.

Indications

ACTOVEGIN ampoules are used to improve cellular energy metabolism and enhance tissue oxygenation. It is indicated for the treatment of the following conditions:

• Cerebral circulation disorders, including ischemic stroke and traumatic brain injuries.
• Peripheral circulation disorders and associated conditions, such as arterial and venous diseases.
• Diabetic polyneuropathy.
• Wound healing impairments, including ulcers, burns, and radiation injuries.
• Prevention and treatment of radiation-induced skin and mucous membrane injuries.
• Supportive therapy for vascular disorders and metabolic support in critically ill patients.

Dosage and Administration

• The dosage and route of administration depend on the condition being treated and the severity of symptoms. It is typically prescribed as follows:
• Cerebral circulation disorders: 10-20 ml intravenously (IV) daily for the first 2 weeks, followed by 5-10 ml IV or intramuscularly (IM) three times per week for up to 4 weeks.
• Peripheral circulation disorders: 20-50 ml IV three times per week for 4 weeks.
• Diabetic polyneuropathy: 50 ml IV daily for 3 weeks, followed by oral Actovegin.
• Administer only under medical supervision. Always dilute Actovegin ampoules with a suitable carrier solution, such as sodium chloride 0.9% or glucose 5%, when given intravenously.

Contraindications

ACTOVEGIN ampoules are contraindicated in the following situations:

• Known hypersensitivity to Actovegin or its components.
• Severe heart failure, pulmonary edema, or oliguria.
• Decompensated renal dysfunction.
• Hyperhydration or fluid overload conditions.

Precautions and Warnings

• Perform a test dose (2 ml intramuscularly) before starting treatment to rule out hypersensitivity reactions.
• Monitor patients closely for allergic reactions, including skin rash, pruritus, or anaphylaxis. Discontinue treatment immediately if such reactions occur.
• In patients with cardiovascular disorders, use with caution to avoid volume overload.
• Ensure proper hydration status, particularly in patients receiving high doses intravenously.
• For diabetic patients, adjust therapy as needed to manage blood sugar levels during treatment.

Adverse Effects

ACTOVEGIN is generally well-tolerated. However, some patients may experience the following side effects:

• Allergic reactions: Skin rash, urticaria, or anaphylactic reactions (rare).
• Gastrointestinal effects: Nausea, vomiting, or abdominal discomfort (rare).
• Cardiovascular effects: Palpitations or flushing (infrequent).
• Injection site reactions: Redness, swelling, or pain.

Drug Interactions

There are no significant interactions reported with ACTOVEGIN. However, avoid mixing it with other medications in the same syringe or infusion line to prevent incompatibilities.

Pregnancy and Lactation

ACTOVEGIN can be used during pregnancy and lactation under medical supervision when the benefits outweigh the risks. It has been used for placental insufficiency and fetal hypoxia, but its safety has not been fully established.

Overdose

No specific cases of overdose have been reported. In case of excessive administration, monitor the patient for signs of fluid overload or metabolic disturbances, and provide symptomatic treatment.

Storage

• Store ACTOVEGIN ampoules at a temperature of 15-25°C, away from direct sunlight and out of reach of children.
• Do not freeze.
• Once opened, use the ampoule immediately. Discard any unused portion.

Patient Information

Patients should be informed about the nature of the treatment and advised to report any unusual symptoms to their healthcare provider promptly. ACTOVEGIN should only be administered under the supervision of a qualified healthcare professional.