Actovegin Injections

 

Therapeutic indications for Actovegin injections

 

• Cerebrovascular disorders, including cognitive impairment following stroke and
  treatment of dementia.
• Peripheral (arterial, venous) bleeding disorders and their sequelae (arterial angiopathies,
  treatment of venous lower leg ulcers).
• Treatment of diabetic polyneuropathy (DPN).
• Other off label indications like treating muscle injury

Dosage and route of administration of Actovegin injections

Actovegin injections can be administered intravenously, intramuscularly or intra-arterially, and can also be added to an infusion solution.

General dosage

Depending on the clinical picture and the severity of the disease, the starting daily dose is 10-20 ml intravenously or intra-arterially once daily. Treatment is continued with 5 ml intravenously or slowly intramuscularly once daily or several times a week. Therapy may be continued with Actovegin Forte 200 mg film-coated tablets.

When used as an infusion
Dilute 10-50 ml with 200-300 ml stock solution (isotonic sodium chloride solution or 5% glucose solution). Administration rate: approximately 2ml/min.When Actovegin solution is used as an infusion, 15 micron filters should be used for infusion systems.

Dosage according to indications

• Treatment of cerebrovascular disorders, dementia: starting dose 10 ml intravenously
  1 time daily, duration of treatment 2 weeks. 5 – 10ml intravenously several times thereafter
  per week, continue treatment for at least 4 weeks.
• Treatment of cognitive impairment following stroke: administer 50ml (2000mg) diluted in stock solution as an intravenous infusion once daily or several days a week for up to 20 infusions, depending on the clinical picture and severity of the disease; therapy continues for up to 6 months with Actovegin Forte 2 tablets 3 times daily (1200mg).
• Diabetic polyneuropathy: administer 50ml (2000mg) diluted in stock solution as an intravenous infusion once daily or several days a week for up to 20 infusions, depending on the clinical picture and severity of the disease; therapy continues for up to 6 months with Actovegin Forte 3 tablets 3 times daily (1800mg).
• Arterial angiopathy: administer 20-50 ml diluted in stock solution intravenously or intra-arterially once daily or several times a week. Duration of treatment approximately 4 weeks.
• Venous ulcers: 10 ml intravenously or 5 ml intramuscularly daily or several times a week, according to the healing process.
  Intramuscular administration should be slow, no more than 5 ml at a time, as the solution is hypertonic.

Use in children
No efficacy data are currently available, so use in children is not recommended.

Contraindications and warning using Actovegin injections

 

Hypersensitivity to Actovegin or a similar medicine, or to any of the excipients.
Contraindications to infusion therapy: congestive heart failure, pulmonary oedema, oliguria, anuria, hyperhydration.

Special warnings and precautions for use

In a study, patients with cognitive impairment after stroke were more likely to have ischaemic stroke
recurrence was observed in the Actovegin group.Aseptic conditions should be observed when using these solutions, as Actovegin solution for injection does not contain preservatives. Actovegin is for single use only.

Open ampoules and ready-to-use solutions should be used immediately.
Dispose of unused medicines or materials in accordance with local requirements.

To avoid the risk of an anaphylactic reaction, a dose (hypersensitivity reaction test) is recommended. All patients should be observed for signs and symptoms of hypersensitivity after first use of Actovegin injections. It is recommended to observe these patients for at least 30 minutes, ensuring that acute medical treatment for anaphylaxis is available.If electrolyte metabolism disturbances occur (e.g. hyperchloremia and hypernatraemia), they should be corrected accordingly.
The solution for injection may have a yellowish tint. The colour may vary depending on the batch and the material originally used. The colour does not affect the efficacy or tolerability of the medicinal product. No turbid solutions or solutions with visible particles should be used.

This medicine contains phenylalanine. May be harmful to patients with phenylketonuria.This medicine contains up to 13.7 mg of sodium per ml of solution. To be observed in patients on a sodium-controlled diet. This medicine contains up to 2.5 mg of potassium per ml of solution. To be observed in patients with renal insufficiency or on a controlled potassium diet.

So far, no interaction is known with other medicinal products and other forms of interaction. No Effects on the ability to drive and to operate machinery has been observed

Pregnancy, fertility and breastfeeding

Pregnancy: Actovegin should only be used during pregnancy if the therapeutic benefits outweigh the potential risks to the foetus. Although rare, there have been reports of fatal cases of Actovegin in placental insufficiency. These cases are contrary to the basic premise. The use of Actovegin in placental insufficiency is not recommended. Breastfeeding: no case of adverse effects of Actovegin on the child has been reported to date, but the therapeutic benefit and potential risk to the child should be assessed.

Adverse reactions to Actovegin injections

The most serious side effects reported with Actovegin are allergic reactions. Particularly observed are
allergy-prone patients.

Immune system disorders
Rare: allergic reactions (drug-induced fever, symptoms of anaphylactic shock)

Lesions of the skin and subcutaneous tissue
Rare: urticaria, swelling

Special instructions for waste disposal and other handling instructions for Actovegin injections

 

Infusions are given using Actovegin injection solutions diluted with isotonic sodium chloride solution or 5% glucose solution.
Physico-chemical incompatibilities as well as interactions between active substances should not be excluded when Actovegin injection solution is mixed with other infusion or injection solutions, even if the solution appears optically clear.Aseptic conditions should be observed when using these solutions, as Actovegin solution for injection does not contain preservatives.

Do not use cloudy solutions or solutions with visible particles.

The solution for injection may have a yellowish tint. The colour may vary depending on the batch and the material originally used. The colour does not affect the efficacy or tolerability of the medicinal product.

Instructions for use of single-use ampoules.

No refilling required.Turn the ampoule with the coloured dot upwards!

Tap and shake the ampoule gently to allow the liquid in the tip of the ampoule to drain down. Dispose of unused medicines or materials in accordance with local requirements.

Specific instructions for use of Actovegin injections

 

• Intramuscular administration should be slow, no more than 5ml at a time, as the solution is hypertonic.
• A test injection is recommended to avoid an anaphylactic reaction.
• When preparing infusion solutions, Actovegin should be diluted with isotonic sodium chloride solution or 5% glucose solution.
• Aseptic conditions should be observed when using these solutions as Actovegin solution for injection does not contain preservatives.
• Physico-chemical incompatibilities as well as interactions between active substances cannot be excluded when Actovegin solution for injection is mixed with other medicinal products. For this reason, Actovegin solution for injection should not be used in combination with other medicinal products, with the exception of the infusion solutions already mentioned (isotonic sodium chloride and 5% glucose solutions).
•  Actovegin solution for injection may have a yellowish tinge. The strength of the colour may vary from batch to batch as a result of the material used initially. The colour does not affect the potency or tolerability of the medicinal product.
• Do not use turbid solutions or solutions with visible particles. From a microbiological point of view, opened ampoules and prepared solutions should be used immediately. Solutions that are not used should be discarded (thrown away).