Forceris (Toltrazuril 30mgml + Iron 133mgml) Suspension for injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TOLTRAZURIL; Gleptoferron

Available from:

Ceva Animal Health Malaysia Sdn. Bhd.

INN (International Name):

TOLTRAZURIL; Gleptoferron

Units in package:

100 ml; 500 ml; 250 ml

Manufactured by:

Ceva Sante Animale

Patient Information leaflet

Not allowed to submit correspondence leaving this attachment empty

Summary of Product characteristics

COMPOSITION
Toltrazuril
.......................................................................................................
30.0 mg
Iron(III)
..........................................................................................................
133.4 mg
(as Gleptoferron)
..........................................................................................
355.2 mg
Excipients q.s.
.....................................................................................................
1.0 mL
Phenol (As
Preservatives)....................................................................................
6.4 mL
PRODUCT DESCRIPTION
Forceris, dark brown suspension for injection containing 133.4 mg of
iron (as gleptoferron 20 %
Fe) and 30 mg of toltrazuril per ml.
PHARMACODYNAMICS
Toltrazuril is a triazinon derivative and an antiprotozoal agent. It
has coccidiocidal activity against
all intracellular development stages of the genera _ Cystoisospora_,
that is, merogony (asexual
multiplication) and gamogony (sexual phase). Iron is an essential
micronutrient. It plays a major
role in the transport of oxygen via haemoglobin and myoglobin, as well
as having a key role in
enzymes,
such
as
cytochromes,
catalases,
and
peroxidases.
Injectable
iron-carbohydrate
complexes, such as gleptoferron, are established haematinic agents in
veterinary medicine and
are effective in significantly increasing the haemoglobin levels in
piglets raised under intensive
farming conditions in which an all milk diet for several weeks does
not provide an adequate
source of iron. Following intramuscular injection, gleptoferron is
absorbed and metabolised to
release the iron for use and/or storage in accordance with the
nutritional status of the animal.
Excess iron is stored principally in the liver.
PHARMACOKINETICS
After intramuscular administration of 1.5 mL/piglet of FORCERIS,
maximal concentrations of 7
mg/L of toltrazuril were reached about 6 days after administration
(Tmax ranging from 4 to 7
days), the AUC was about 57 day.mg/L. Toltrazuri