CO-ARINATE JUNIOR

Country: Nigeria

Language: English

Source: NAFDAC (National Agency for Food and Drugs Administration and Control)

Active ingredient:

artesunate, sulfamethoxypyrazine, pyrimethamine

Available from:

Dafra Pharma GmbH

INN (International Name):

artesunate, sulfamethoxypyrazine, pyrimethamine

Pharmaceutical form:

Tablets

Manufactured by:

ERFA NOV/S.A LANDBOAWERSSTRAAT 25,B-1040/BRUSSEL

Therapeutic indications:

CO-ARINATE is used as curative treatment for all forms of malaria, including severe malaria caused by multi drug-resistant strains of Plasmodium falciparum. In case of P. vivax addition of primaquine may be required. CO-ARINATE has been especially designed to treat malaria in children, adolescents and adults.

Product summary:

Each tablet CO-ARINATE Junior contains 100 mg artesunate, 250 mg sulfamethoxypyrazine and 12,5 mg pyrimethamine. Box containing 1 blister of 3 tablets. Other pharmaceutical form: CO-ARINATE Adult: each tablet contains 200 mg artesunate, 500 mg sulfamethoxypyrazine and 25 mg pyrimethamine.

Summary of Product characteristics

Dafra Pharma
Dossier: Co-Arinate Junior
RA Departement
Summary of Product Characteristics
SmPC
Page 1 of 6
Date: 26/01/2017
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Co-Arinate
®
Junior
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet Co-Arinate® Junior contains 100 mg artesunate, 250 mg
sulfamethoxypyrazine and 12,5 mg pyrimethamine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Box containing 1 blister of 3 tablets.
OTHER PHARMACEUTICAL FORM: Co-Arinate® Adult: each tablet contains
200 mg artesunate,
500 mg sulfamethoxypyrazine and 25 mg pyrimethamine.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-Arinate® is used as curative treatment for all forms of malaria,
including severe
malaria caused by multi drug-resistant strains of Plasmodium
falciparum. In case of P.
vivax addition of primaquine may be required. Co-Arinate® has been
especially designed
to treat malaria in children, adolescents and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
The dose for this treatment is based on body weight at 4 mg / kg of
artesunate
combined with sulfamethoxypyrazine and pyrimethamine.
Three consecutive intakes of this dose must be given during 48 hours:

A first tablet is taken upon confirmation of malaria diagnosis (at
Time 0)

A second tablet is taken 24 hours later

The final tablet is taken after a further 24 hours have passed;
therefore there is an
interval of 24 hours between doses which must be adhered to.
Dafra Pharma
Dossier: Co-Arinate Junior
RA Departement
Summary of Product Characteristics
SmPC
Page 2 of 6
Date: 26/01/2017
Dosage scheme for the 48 hour treatment:
Presentation
Weight (kg)
Age (in years)
Number of tablets
Total course
0 h
24 h
48 h
Co-Arinate® Junior
≥ 10 – < 18 kg
(1 - 5 years)
1/2
1/2
1/2
1,5 tablets
≥ 18 – < 36 kg
(6 – 13 years)
1
1
1
3 tablets
The tablets should be taken with fluid such as drinking water. In
order to facilitate
administration they may be crushed if necessary.
Note: A full course of th