Description

Product Overview

WHAT Artesunate IS AND WHAT IT IS USED FOR

Artesunate is for preparation of a solution for intravenous or intramuscular injection.

Artesunate is used for the treatment of severe falciparum malaria caused by the parasite Plasmodium falciparum.

BEFORE USE OF Artesunate

Artesunate should not be used:
If the person is hypersensitive (allergic) to any component of this product.

Take special care with Artesunate
After intravenous or intramuscular treatment of the critical phase of the falciparum malaria infection, the person will need to take oral medication to complete the treatment and avoid relapse.
* Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only.

Taking other medicines

Please inform the doctor, health care provider or pharmacist if the person is taking or has recently taken any other medicines, including medicines bought without prescription

Pregnancy and breast-feeding

This medicine may need to be used when the person is pregnant. A small amount of the medicine enters human breast milk, but it will not protect the child from malaria. The doctor or health care provider will advise the person on breast-feeding.

HOW Artesunate IS USED

Artesunate may be injected intravenously (into a vein) or intramuscularly (into a muscle).
The duration of treatment is at least one day, and will be determined by the doctor or health care provider.

For each dose a new syringe and injection needle must be used.

If you have any further questions on the use of this product, ask your doctor, health care provider or
Pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Artesunate can cause side effects, but not everybody gets them. Some of these may be difficult to detect, and may be similar to effects of the disease itself.

Common side effects (reported in 1 to 10 out of 100 patients):
Dizziness, feeling sick, vomiting, light-headedness, headache, sleeplessness, hearing problems, ’flu-like effects (including fever, tiredness, bone and muscle pain), cough, altered taste, abdominal pain, diarrhoea, rash, and pain at injection site.

Uncommon side effects (reported between 1 in 1000 and 1 in 100 patients treated):
Anaemia (low red blood cell count), neutropenia (low white blood cell count), reduction in platelets (which are important for blood clotting) and allergic reactions.

Rare side effects (reported in less than 1 in 1000 patients):
Inflammation of the liver (hepatitis, with yellowing of eyes and skin) and inflammation of the pancreas (pancreatitis).

Very rare side effects (reported in less than 1 in 10,000 patients):
Severe reduction in red blood cells, tingling sensation and nerve pain.

Frequency not known:
Anaemia has been reported after treatment but it is not known how frequently this effect occurs.

HOW Artesunate IS STORED

Artesunate should be kept out of the sight and reach of children.
Artesunate is stored in the original packing, below 30° C, until it is ready to be used to create a solution. The reconstituted and diluted solutions should be stored below 30oC and the total in-use period should not exceed one hour.

Protect against direct sunlight. Do not store in a refrigerator or freezer.

The product must be destroyed if crystals or cloudiness are visible in the solution.

Do not use Artesunate after the date indicated by “EXP —–” on the immediate and the outer
labelling.