ASAQ GPSC 50MG+135MG ORAL SOLID ORDINARY TABLETS

Ülke: Uganda

Dil: İngilizce

Kaynak: National Drug Authority

Aktif bileşen:

ARTESUNATE+AMODIAQUINE

Mevcut itibaren:

GUILIN PHARMACEUTICALS CO.LTD

INN (International Adı):

ARTESUNATE+AMODIAQUINE

Doz:

50MG+135MG

Farmasötik formu:

ORAL SOLID ORDINARY TABLETS

Paketteki üniteler:

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

Yetkilendirme tarihi:

2011-07-01

Bilgilendirme broşürü

Amodiaquine (as hydrochloride)/Artesunate
135mg/50mg Tablets
(Guilin Pharmaceutical Co. Ltd), MA084
WHOPAR part 3
April 2014
Updated: February 2018
1 of 6
PATIENT INFORMATION LEAFLET
Amodiaquine (as hydrochloride)/Artesunate
135mg/50mg Tablets
(Guilin Pharmaceutical Co. Ltd), MA084
WHOPAR part 3
April 2014
Updated: February 2018
2 of 6
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
ASAQ GPSC™ (50MG/135MG)
*
artesunate/amodiaquine (as hydrochloride) 50mg/135 mg tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 health care provider
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your health care provider. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What ASAQ GPSC™(50mg/135mg) is and what it is used for
2.
What you need to know before you take ASAQ GPSC™(50mg/135mg)
3.
How to take ASAQ GPSC™(50mg/135mg)
4.
Possible side effects
5.
How to store ASAQ GPSC™(50mg/135mg)
6.
Contents of the pack and other information
1. WHAT ASAQ GPSC™ (50MG/135MG) IS AND WHAT IT IS USED FOR
This medicine is an antimalarial, i.e, a drug used to treat a certain
type of malaria infection.
ASAQ GPSC™ (50mg/135mg) contains two antimalarial medicines,
artesunate and amodiaquine,
which work together to kill the malaria parasite (tiny organism that
is found inside the red blood cells).
Your health care provider has found that you have malaria and so has
prescribed ASAQ GPSC™
(50mg/135mg).
It is indicated only for the treatment of so called uncomplicated
malarial attacks due to
_Plasmodium _
_falciparum_
(a particular type of malaria parasite) against which the medicine is
active. For complete
cure it is important that you complete the prescribed dos

Ürün özellikleri

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