ASAQ GPSC 25 MG + 67.5 MG ORAL SOLID ORDINARY TABLETS

Pays: Ouganda

Langue: anglais

Source: National Drug Authority

Ingrédients actifs:

ARTESUNATE + AMODIAQUINE

Disponible depuis:

GUILIN PHARMACEUTICALS CO.LTD

DCI (Dénomination commune internationale):

ARTESUNATE + AMODIAQUINE

Dosage:

25 MG + 67.5 MG

forme pharmaceutique:

ORAL SOLID ORDINARY TABLETS

Unités en paquet:

1.0X1.0X3.0X20.0 TABLET BLISTER,1.0X25.0X3.0 TABLET BLISTER,1.0X25.0X6.0 TABLET BLISTER

Date de l'autorisation:

2011-07-01

Résumé des caractéristiques du produit

ML ASAQ winthrop – August 2010-V1
Page 1 of 11
ARTESUNATE AMODIAQUINE WINTHROP 25 MG/67.5 MG, TABLET
ARTESUNATE AMODIAQUINE WINTHROP 50 MG/135 MG, TABLET
ARTESUNATE AMODIAQUINE WINTHROP 100 MG/270 MG, TABLET
NAME OF THE MEDICINAL PRODUCT
_ARTESUNATE AMODIAQUINE WINTHROP_
®
25MG/67.5MG TABLETS
Artesunate, amodiaquine
_ARTESUNATE AMODIAQUINE WINTHROP_
®
50MG/135MG TABLETS
Artesunate, amodiaquine
_ _
_ARTESUNATE AMODIAQUINE WINTHROP_
®
100MG/270MG TABLETS
Artesunate, amodiaquine
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ARTESUNATE AMODIAQUINE WINTHROP _
is a fixed dose combination of amodiaquine and artesunate.
Each ARTESUNATE AMODIAQUINE WINTHROP 25mg/67.5mg tablet contains 25
milligrams of
artesunate 67.5 milligrams of amodiaquine
_ (as hydrochloride)_
Each ARTESUNATE AMODIAQUINE WINTHROP 50mg/135mg tablet contains 50
milligrams of
artesunate and 135 milligrams of amodiaquine
_ (as hydrochloride)_
.
Each ARTESUNATE AMODIAQUINE WINTHROP 100mg/270mg tablet contains 100
milligrams
of artesunate and 270 milligrams of amodiaquine
_ (as hydrochloride)_
.
PHARMACEUTICAL FORM
Tablets :
ARTESUNATE AMODIAQUINE WINTHROP 25mg/67.5mg is a round bilayer tablet
: one layer is
yellow coloured, the other one is white to slightly yellow, with score
line, engraved on one side “AS”
and on the other side “25”.
ARTESUNATE AMODIAQUINE WINTHROP 50mg/135mg is a round bilayer tablet :
one layer is
yellow coloured, the other one is white to slightly yellow, with score
line, engraved on one side “AS”
and on the other side “50”.
ARTESUNATE AMODIAQUINE WINTHROP 100mg/270mg is a round bilayer tablet
: one layer is
yellow coloured, the other one is white to slightly yellow, with score
line, engraved on one side “AS”
and on the other side “100”.
The tablets may be mottled but it does not alter the safety and
effectiveness of the product.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
ML ASAQ winthrop – August 2010-V1
Page 2 of 11
CLINICAL PARTICULARS
THERAPEUT