SN-FLORFENICOL 5%ww ORAL POWDER

Country: Malaysia

Language: English

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

Active ingredient:

FLORFENICOL

Available from:

Shennong Animal Health (Malaysia) Sdn. Bhd.

INN (International Name):

FLORFENICOL

Units in package:

1 kg

Manufactured by:

Shennong Animal Health (Malaysia) Sdn. Bhd.

Summary of Product characteristics

SN-FLORFENICOL 5%W/W
ORAL POWDER
(FOR VETERINARY USE ONLY)
COMPOSITION
Florfenicol
……..……….………………………..……………….........................
50 mg/g
PRODUCT DESCRIPTION
The finished product is a white color powder.
TARGET SPECIES
Pigs (Fattening pigs)
PHARMACODYNAMIC
Florfenicol is a broad-spectrum synthetic antibiotic in the phenicol
group
that is active against most Gram-positive and Gram-negative bacteria
isolated from domestic animals. Florfenicol acts by inhibition of
protein
synthesis at the ribosomal level and is bacteriostatic.
PHARMACOKINETIC
After administration to pigs by gavage at 10 mg/kg under experimental
conditions,
absorption
of
florfenicol
was
variable
but
peak
serum
concentrations of approximately 5µg/ml were reached approximately
3 hours after dosing. The terminal half-life was between 3 and 4
hours.
When pigs were given free access, for 5 days, to feed medicated with
florfenicol (premix for medicated feeding stuff) at the recommended
dose of 10 mg/kg serum florfenicol concentrations exceeded 1 µg/ml
for
more than 16 hours each day of treatment.
Florfenicol is well absorbed when administered orally
and following
distribution it is rapidly eliminated in the urine and faeces in a
ration of
3:1. A fraction is excreted unchanged and the rest is metabolised into
5
major metabolites.
INDICATIONS
In fattening pigs:
For
the
treatment
and
prevention
of
swine
respiratory
disease
in
infected herds due to _ Pasteurella multocida_ susceptible to
florfenicol.
The presence of the disease should be established in the herd before
initiating preventive treatment.
WARNINGS AND PRECAUTIONS
1. SPECIAL WARNINGS FOR EACH TARGET SPECIES:
Animals showing a decreased appetite and/or a poor general condition
should be treated by the parenteral route.
2. SPECIAL PRECAUTIONS FOR USE:
I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
The product should be used in conjunction with susceptibility testing
and take into account official and local policy relating to the use of
antimicrobials.
Use of