Artesunate Amivas

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

artesunate

Available from:

Amivas Ireland Ltd

ATC code:

P01BE03

INN (International Name):

artesunate

Therapeutic group:

Antiprotozoals

Therapeutic area:

Malaria

Therapeutic indications:

Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children.Consideration should be given to official guidance on the appropriate use of antimalarial agents.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2021-11-22

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARTESUNATE AMIVAS 110
MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
artesunate
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Artesunate Amivas is and what it is used for
2.
What you need to know before you are given Artesunate Amivas
3.
How Artesunate Amivas is given
4.
Possible side effects
5.
How to store Artesunate Amivas
6.
Contents of the pack and other information
1.
WHAT ARTESUNATE AMIVAS IS AND WHAT IT IS USED FOR
Artesunate Amivas contains the active substance artesunate. Artesunate
Amivas is used to treat severe
malaria in adults and children.
After treatment with Artesunate Amivas your doctor will complete your
treatment for malaria with a
course of anti-malarial medication that can be taken by mouth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ARTESUNATE AMIVAS
_ _
DO NOT USE ARTESUNATE AMIVAS
-
if you are allergic to artesunate, to any other antimalarial treatment
that contains an artemisinin
(e.g. artemether or dihydroartemisinin) or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
You may develop anaemia, a reduced number of red blood cells, or other
blood changes after
treatment with this medicine. Some changes to numbers of blood cells
can occur while you are being
treated and usually recover after stopping treatment for malaria.
However, some individuals develop
severe anaemia that can occur up

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Artesunate Amivas 110 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 110 mg of artesunate.
Each vial of solvent for reconstitution contains 12 mL of 0.3 M sodium
phosphate buffer.
After reconstitution, the solution for injection contains 10 mg of
artesunate per mL.
Excipient(s) with known effect:
After reconstitution, the solution for injection contains 13.4 mg
sodium per mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder: white or almost white, fine crystalline powder.
Solvent: clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Artesunate Amivas is indicated for the initial treatment of severe
malaria in adults and children (see
sections 4.2 and 5.1).
Consideration should be given to official guidance on the appropriate
use of antimalarial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that Artesunate Amivas should be used to treat
patients with severe malaria only
after consultation with a physician with appropriate experience in the
management of malaria.
Posology
Initial treatment of severe malaria with artesunate should always be
followed by a complete treatment
course with appropriate oral antimalarial therapy.
_Adults and children (birth to less than 18 years)_
The recommended dose is 2.4 mg/kg (0.24 mL of reconstituted solution
for injection per kg body
weight) by intravenous (IV) injection at 0, 12 and 24 hours (see
sections 4.4 and 5.2).
3
After at least 24 hours (3 doses) treatment with Artesunate Amivas,
patients unable to tolerate oral
treatment may continue to receive