SPAQ-CO DISP Dispersible Tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Sulfadoxine/Pyrimethamine/Amodiaquine (as Hydrochloride)

Available from:

Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd, CHINA

ATC code:

Antimalarials, Aminoquinolines

INN (International Name):

Sulfadoxine/Pyrimethamine/Amodiaquine (as Hydrochloride)

Dosage:

500/25

Pharmaceutical form:

Dispersible Tablets

Manufactured by:

GUILIN PHARMACEUTICAL CO., LTD, CHINA

Product summary:

Physical description: Amodiaquine dispersible tablets are tablets with yellow core debossed with AM on one side and a score line on the other side Sulfadoxine /pyrimethamine dispersible tablets are white round tablets, debossed with SP on one side and a score line on the other side; Local technical representative: KITETO DISTRICT COUNCIL (5773)

Authorization status:

Registered/Compliant

Authorization date:

2022-07-19

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SPAQ-CO
®
DISP
Sulfadoxine/Pyrimethamine250mg/12.5mg
+
Amodiaquine
(as
Hydrochloride)
76.5mg co-blistered dispersible tablets.
Sulfadoxine/Pyrimethamine500mg/25mg + Amodiaquine (as Hydrochloride)
153mg
co-blistered dispersible tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_SPAQ-CO DISP (AMODIAQUINE (100 MG AS HYDROCHLORIDE) 76.5MG
DISPERSIBLE _
_TABLETS+ SULFADOXINE / PYRIMETHAMINE (250/12.5MG) DISPERSIBLE TABLET)
_
Each
amodiaquine
dispersible
tablet
contains
76.5mg
amodiaquine
(as
hydrochloride).
Each sulfadoxine/pyrimethamine dispersible tablet contains 250mg
sulfadoxine and
12.5mg pyrimethamine.
For a full list of excipients, see section 6.1.
_SPAQ-CO DISP (AMODIAQUINE (200 MG AS HYDROCHLORIDE) 153MG DISPERSIBLE
_
_TABLETS+ SULFADOXINE / PYRIMETHAMINE (500/25MG) DISPERSIBLE TABLET) _
Each
amodiaquine
dispersible
tablet
contains
153mg
amodiaquine
(as
hydrochloride).
Each sulfadoxine/pyrimethamine dispersible tablet contains 500 mg
sulfadoxine and
25 mg pyrimethamine.
_For a full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
Amodiaquine dispersible tablets are tablets with yellow core debossed
with “AM” on
one side and a score line on the other side. The score-line is to
facilitate breaking for
ease of swallowing and not to divide the tablet into equal doses.
Sulfadoxine /pyrimethamine dispersible tablets are white round
tablets, debossed
with “SP” on one side and a score line on the other side. The
score-line is to facilitate
breaking for ease of swallowing and not to divide the tablet into
equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
SPAQ-CO
Disp
is
indicated
for
malaria
prevention
during
the
malaria
season
(seasonal malaria chemoprevention,SMC) in infant aged 3- 12 months and
children
aged
12–59
months
throughout
the
Sahel
sub-region
of Africa,
provided
that
amodiaquine and pyrimethamine/sulfadoxine retain sufficient
antimalarial efficacy.
The most recent official guidelines on the use of