Co-Artesiane Suspension, Oral 360mg/120ml + 2160mg/120ml

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Artemether , Lumefantrine

Available from:

Dafra Pharma GmbH, SWITZERLAND

INN (International Name):

Artemether + Lumefantrine

Dosage:

360mg/120ml + 2160mg/120ml

Pharmaceutical form:

Suspension, Oral

Manufactured by:

MPF bv, THE NETHERLANDS

Product summary:

Physical description: YELLOW POWDER; Local technical representative: Harley's (T) Limited

Authorization status:

Registered/Compliant

Authorization date:

2016-05-02

Patient Information leaflet

CO-ARTESIANE
Form:
Suspension
Dosage:
360/2160mg
Packaging:
Bottle 120ml
PRODUCT INFORMATION
CO-ARTESIANE
®
is an Artemether based Combination Therapy (ACT) which contains two
medicaments active against malaria parasites.
In their combination, the drug Artemether kills the parasites very
fast and potentiates the effects of the
second drug Lumefantrine. This combination therapy permits a shorter
duration of treatment, thereby
improving compliance.
The theoretical risk for drug resistance is significantly reduced by
using combination therapy.
CO-ARTESIANE
®
is a dry powder for oral suspension which contains two active
ingredients called
Artemether (ß-Artemether) and Lumefantrine.
There are two presentations available: one to make a 60 ml suspension
and another to make a 120 ml
suspension:
•
Artemether/Lumefantrine powder for suspension 60 ml, containing a
fixed dose combination of
180 mg of ß-Artemether and 1080 mg of Lumefantrine.
•
Artemether/Lumefantrine powder for suspension 120 ml, containing a
fixed dose combination
of 360 mg of ß-Artemether and 2160 mg of Lumefantrine.
THERAPEUTIC INDICATIONS
CO-ARTESIANE
®
is indicated for the treatment of malaria in children, caused by all
forms of
_Plasmodium _including severe malaria caused by multiple drug
resistant strains of _P. falciparum_.
In case of a _P. vivax _malaria infection an additional treatment with
primaquine may be required.
POSOLOGY AND METHOD OF ADMINISTRATION
CO-ARTESIANE
®
suspension has especially been designed for its use in children.
The dose depends on the severity of the case and the clinical
situation of the patient.
In general:4 mg Artemether/kg body weightin combination with
Lumefantrine per day.
This dose should be maintained during three consecutives days.
The daily dose should be administered in _one intake._
NOTE: a full course therapy of three days is essential in order to
avoid recrudescence.
In case of vomiting within 30 minutes after intake of the suspension,
the full dose should be re-
administered. Vomiting within 1 hour

Summary of Product characteristics

CO-ARTESIANE
®
(Powder for oral suspension of ß-Artemether and Lumefantrine)
1. NAME OF THE MEDICINAL PRODUCT
Co-Artesiane
suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 GENERAL DESCRIPTION
Co-Artesiane is an Artemether based Combination Therapy (ACT) which
contains two
medicaments active against malaria parasites.
In their combination, the drug Artemether kills the parasites very
fast and potentiates the effects
of the second drug Lumefantrine.
This combination therapy permits a shorter duration of treatment,
thereby improving compliance.
The theoretical risk for drug resistance is significantly reduced by
using combination therapy.
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-Artesiane is a dry powder for oral suspension which contains two
active ingredients called
Artemether (ß-Artemether) and Lumefantrine.
There are two presentations available: one to make a 60 ml suspension
and another to make a 120
ml suspension:

Artemether/Lumefantrine powder for suspension 60 ml,
containing a fixed dose combination of
180 mg of ß-Artemether and 1080 mg of Lumefantrine.

Artemether/Lumefantrine powder for suspension 120 ml,
containing a fixed dose combination of
360 mg of ß-Artemether and 2160 mg of Lumefantrine.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dry powder for oral suspension of ß-Artemether and Lumefantrine.
Each cardboard box contains 1 plastic bottle containing Artemether and
Lumefantrine in a dry
powder mixture for making up a suspension with water.
After adding water to the mark point and vigorously shaking the
mixture, a yellow suspension
with a pleasant sweet coconut taste is formed.
Each packaging contains a package leaflet and a graded beaker with
marks at 1 ml intervals and 5
ml intervals.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Co-Artesiane is indicated for the treatment of malaria in children,
caused by all forms of
_Plasmodium _including severe malaria caused by multiple drug
resistant strains of _P. falciparum_.
In case of a _P. viv