EFFORTIL Solution for injection Ref.[51028] Active ingredients: Etafedrine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Pharmaco Distribution (Pty) Ltd, 3 Sandown Valley Crescent, South Tower, First Floor, Sandton 2196, Gauteng, South Africa Ethical assistance Line: +27 (0) 784 00 77

4.1. Therapeutic indications

To correct hypotension in:

a) circulatory failure
b) during anaesthesia
c) post-operatively

4.2. Posology and method of administration

Posology

EFFORTIL can be administered as intravenous injection or drip infusion, subcutaneously and intramuscularly.

The recommended doses are as follows:

Children under 1 year - ½ to 1 ampoule (10 mg) daily

4 years – up to 1½ ampoules daily

8 years – 1 to 2 ampoules daily

13 years – 1½ to 3 ampoules daily

Adults – 3 to 6 ampoules daily

For infusion physiological saline solution, lactated Ringer’s solution, 5% glucose solution or 10% xylitol solution without any further additives should be used.

4.9. Overdose

Symptoms

Acute overdosage or excessively rapid intravenous injection intensifies the adverse effects previously described. In addition, agitation and vomiting may occur. In babies and small children, overdosage may cause central respiratory paralysis and coma.

Treatment

Symptomatic and supportive treatment should be given as appropriate. Intensive care measures should be taken in cases of severe overdosage. Symptoms which are due to β1-sympathomimetic activity may be treated with β1-blockers administered in accordance with the usual therapeutic guidelines for this class of medicines.

6.3. Shelf life

36 months.

From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4. Special precautions for storage

Store at or below 30°C in a dry place and protect from light.

For storage conditions after dilution, see section 6.3.

Keep out of reach of children.

Do not use this medicine after the expiry date printed on the label.

6.5. Nature and contents of container

Amber glass ampoules containing 1 ml of solution in packs of 5.

6.6. Special precautions for disposal and other handling

For infusion physiological saline solution, lactated Ringer’s solution, 5% glucose solution or 10% xylitol solution without any further additives should be used.

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