Artesunate pdr./inj 60mg vial/BOX-1

General Description:
Artesunate powder for i.m./i.v. Injection, 60mg in vial together with 1 ml ampoule of 5% Sodium bicarbonate BP and 5ml ampoule of 0.9% (9mg/ml) Sodium Chloride inj as diluent, BOX of 1

Technical Specifications:
Each box contains the following
1.One vial of Artesunate (as Artesunate acid) powder for Injection, 60mg
2.One ampoule of 5% Sodium bicarbonate.
3.One ampoule of 0.9% Sodium Chloride Injection

Note: Artesunic acid is converted to Sodium Artesunate on mixing with Sodium bicarbonate and then diluted with 0.9% Sodium chloride before administration

Therapeutic class:
Artesunate is the water soluble sodium salt of the hemisuccinate ester of Dihydroartemesinin.

Standard shelf life:
3 years (36 months)

Other available formulations:
The product may also be available in other formulations or pack sizes.

Indications:
Treatment of acute complicated and cerebral malaria caused by P. falciparum alone or with other Plasmodium spp. In areas with significant drug resistance, especially in unconscious patients.

Route of Administration:
Parenteral-intramuscular (I.M.) or intravenous injection (I.V.)

Dosage:
Suggested dosing is based on the WHO guidelines for the treatment of Malaria, please click the link listed below:
http://www.who.int/malaria/publications/atoz/9789241549127/en/

Storage:
Artesunate is unstable in neutral solution and therefore, is provided only as Artesunic acid powder.
Store dry and at temperatures not exceeding 30°C (86°F).
Keep out of the reach and sight of children.
Protect from light.

Dispensing instructions:
Dispense in original container. Do not repack

Instructions for reconstitution and administration:
1. Mix the Artesunic acid powder with 1ml of 5% Sodium bicarbonate and shake for 2-3 minutes. The powder is difficult to dissolve and care should be taken to shake the mixture until the solution becomes clear.
2. The solution for injection should be freshly prepared immediately before use.
3. Do not use if the solution is cloudy or sediments are visible.
Intravenous use
a. Add 5ml of 0.9% Sodium chloride (Physiological saline) OR 5% Glucose to the resulting solution to make a final concentration of Artesunate Sodium 10mg/ml.
b. The required amount of drug is administered by slow intravenous injection at the rate of 3-4ml per minute.
c. Should NOT be given as I.V infusion.
Intramuscular use
a. Add 2ml of 0.9% Sodium chloride (Physiological saline) OR 5% glucose to the resulting solution to make a final concentration of Artesunate Sodium 20mg/ml.
b. The required amount of drug is administered I.M to the anterior thigh.

Note: The solution should be injected immediately after reconstitution and dilution. Any quantity left over after administration should be discarded immediately and NOT STORED.

Guidelines for use:
For more details, please see World Health Organisation (WHO),
Guidelines for the treatment of Malaria:

WHO Model List of Essential Medicines:


WHO Model Formulary:


http://apps.who.int/medicinedocs/documents/s16879e/s16879e.pdf


Regulatory Status:
For latest updates check the list of ‘Prequalified Medicines’ on the WHO website ‘Prequalification Programme’. apps.who.int/prequal/