Florfenicol 25 % wv Oral Solution

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:

1000 ml

Manufactured by:

Shennong Animal Health (Malaysia) Sdn. Bhd.

Summary of Product characteristics

FLORFENICOL 25%W/V
Oral Solution
(FOR VETERINARY USE ONLY)
COMPOSITION
Florfenicol
………………………….…………………..……….....................
250 mg
Exp q.s to
……………..………….………………....…………….…….……………..
1 ml
PRODUCT DESCRIPTION
The finished product is a clear yellowish solution.
TARGET SPECIES
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.
In-vitro
testing
has
shown
that
florfenicol
is
active
against
the
bacterial pathogens most commonly isolated in respiratory diseases
in pigs, including _ Actinobacillus pleuropneumoniae_ and _
Pasteurella _
_multocida_.
PHARMACOKINETIC
After
absorption
and
distribution,
florfenicol
is
extensively
metabolised by pigs and rapidly eliminated, primarily in urine. After
parenteral dosing of florfenicol to pigs, it has been shown that lung
concentrations are similar to serum concentrations.
INDICATIONS
Treatment and prevention at the group level where clinical signs are
present of swine respiratory disease associated with _ Actinobacillus
_
_pleuropneumoniae_
and
_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:
The treated pigs should be placed under special observation. On
each of the five days of treatment, unmedicated drinking water
should not be given until the full daily amount of medicated drinking
water has been ingested by pigs. If there are no signs of
improvement after three days of treatment, the diagnosis should be
reviewed and, if necessary, the treatment changed.
2. SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
The veterinary medicinal product should be used in conjunction
with susce