TP-Flor 110 Sol Florfenicol 110mgml Solution

Страна: Малайзия

Език: английски

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

Активна съставка:

FLORFENICOL

Предлага се от:

Thye Pharma Sdn. Bhd

INN (Международно Name):

FLORFENICOL

Броя в опаковка:

1l kg

Произведено от:

Thye Pharma Sdn. Bhd

Данни за продукта

Veterinary Package Insert
TP-Flor 110 SOL Florfenicol 110mg/ml
Solution
PRODUCT DESCRIPTION
Light yellow colour liquid, which contains florfenicol
110mg in 1ml of solution (11% in w/v).
PHARMACODYNAMICS & PHARMACOKINETICS
Florfenicol is a synthetic broad spectrum antibiotic
active
against
many
gram-negative
and
gram-
positive bacteria isolated from domestic animals. It
acts by inhibiting bacterial protein synthesis. In vivo
activity has been demonstrated against bacterial
pathogens
commonly
associated
with
swine
respiratory
disease,
including Actinobacillus
pleuropneumoniae and Pasteurella
multocida.
In
vitro activity
has
been
demonstrated
against Salmonella spp
and Streptococcus
suis and in
vitro activity
against
Mycoplasma
hyopneumoniae and Mycoplasma
hyorrhinis has
been detected. However, the clinical significance of
this activity in swine is not known.
_For Swine: _
Florfenicol
was
detectable
in
the
serum
of
all
animals
through
12
hours
after
gavage.
After
gavage of florfenicol on the fifth day, the maximum
serum
florfenicol
concentrations
were
between
2.78
µg/mL
and
7.34
µg/mL
and
the
median
terminal
half
life
was
2.0
hours.
The
extent
of
bioavailability ranged from 24% to 97%.
_For Chicken: _
After
the
first
oral
gavage
administration
of
florfenicol of 42 mg/kg bw/day for 3 days to broiler
chicken, the highest concentration of florfenicol in
serum
(12200
µg/l)
was
measured
after
30
minutes and then declined to reach 810 µg/l, 8
hours later. Florfenicol could not be detected in the
serum, 60 hours after the last administration.
During a continuous treatment for broiler chicken
with florfenicol in drinking water at a daily dose of
26
mg/kg
bw
for
18
hours
for
3
days,
the
estimated mean serum concentration of florfenicol
was 711 µg/l. No florfenicol was detected in the
serum, 72 hours after the terminal dose.
INDICATION
_Broiler Chickens: _The product is indicated in broiler
chickens
for
the
treatment
and
control
of
air
sacculitis
associated
with E.
coli susceptible
to
florfenicol.
_Swine: _The product is