Co-Artesiane Powder for Oral suspension 3mg/ml + 18mg/ml

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Artemether , Lumefantrine

Available from:

Dafra Pharma GmbH, SWITZERLAND

ATC code:

Antimalarials

INN (International Name):

Artemether + Lumefantrine

Dosage:

3mg/ml + 18mg/ml

Pharmaceutical form:

Powder for Oral suspension

Manufactured by:

S KANT HEALTHCARE LIMITED, INDIA

Product summary:

Physical description: Yellow coloured powder, having coconut odour; Local technical representative: Harleys (T) Limited (4194)

Authorization status:

Registered/Compliant

Authorization date:

2022-04-11

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT (FPP)
Co-Artesiane®
_Artemether –Lumefantrine _
1.1. STRENGTH
Artemether 3 mg/ml
Lumefantrine 18 mg/ml
1.2. PHARMACEUTICAL FORM
Powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
QUALITATIVE DECLARATION Artemether Lumefantrine
_For a full list of excipients, see section 6.1. _
2.2. QUANTITATIVE DECLARATION
Co-Artesiane 60 ml
Bottle
with
22, 8
g
of
powder
containing
180
mg
of Artemether and
1080
mg
of
Lumefantrine
Co-Artesiane 120 ml
Bottle
with
45, 6
g
of
powder
containing
360
mg
of Artemether and
2160
mg
of
Lumefantrine.
EXCIPIENTS WITH KNOWN EFFECT:
Methyl parahydroxybenzoate 0,8 mg/ml
Propyl parahydroxybenzoate 0,2 mg/ml
Sucrose 328 mg/ml
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
Yellow powder
The reconstituted suspension has a yellow colour and a taste of
coconut
4.
CLINICAL PARTICULARS
1.
THERAPEUTIC INDICATIONS
Co-Artesiane is indicated for the treatment of malaria in adults and
children weighing 5 kg
and above, due to Plasmodium _falciparum. _
The most recent official guidelines on the appropriate use of
antimalarial agents and local
information on the prevalence of resistance to antimalarial drugs
should be taken into
consideration for deciding on the appropriateness of therapy._ _
4.1.POSOLOGY AND MODE OF ADMINISTRATION
4.1.1.
POSOLOGY
Co-Artesiane is intended for pediatric use (see posology 4.2.3), but
can also be used by
adults.
The dose depends on the severity of the case and the clinical
situation of the patient.
A standard 3-days-treatment schedule is recommended.
Full course therapy of three days is essential in order to avoid
recrudescence.
DOSAGE SCHEME
The dose for each patient is calculated based on the body weight.
One
(1)
ml
of
the
reconstituted
suspension
contains
3
mg Artemether
and
18 mg
Lumefantrine.
ADDITIONAL INFORMATION
A further course of Co-Artesiane may be necessary if the malaria
infection returns (relapse)
or if re-infection with a different strain of Plasmodium parasites
occur