Florfen 10% wv Oral Solution

Country: Malaysia

Language: English

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

Active ingredient:

FLORFENICOL

Available from:

Nam Pharma Sdn. Bhd.

INN (International Name):

FLORFENICOL

Units in package:

1.00 mcg/mL

Manufactured by:

Nam Pharma Sdn. Bhd.

Summary of Product characteristics

FLORFEN 10% W/V ORAL SOLUTION
FLORFEN appears to be a light yellow solution.
COMPOSITION:
Each Litre contains
Florfenicol
100 g
PHARMACODYNAMICS:
Florfenicol is a bacteriostatic antibiotic that inhibits protein
synthesis
by binding to ribosomal subunits of susceptible bacteria, leading to
the inhibition of peptidyl transferase and thereby preventing the
transfer of amino acids to growing peptide chains and subsequent
protein formation. The bacterial receptor that is the site of action
for
florfenicol is considered to be the same as that for chloramphenicol
and thiamphenicol.
PHARMACOKINETICS:
After administration to pigs by gavage at 15 mg/kg under
experimental conditions, absorption of florfenicol was variable but
peak serum concentrations of approximately 5 µg/mL were reached
approximately 2 hours after dosing. The terminal half-life was
between 2 and 3 hours. When pigs were given free access, for 5 days,
to water medicated with Florfen at a concentration of 100 mg
florfenicol per litre of water, serum concentrations of florfenicol
exceeded 1 µg/mL for the entire 5 day treatment period except for a
couple of short excursions below 1 µg/mL. 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.
For broiler chickens, serum concentrations versus time in chickens
after the administration of florfenicol in drinking water at an
expected
concentration of 100ppm for 18 hours per day over 3 days.
INDICATIONS:
BROILER CHICKENS: Florfen 10% w/v oral solution is indicated in
broiler chickens for the treatment and control of air sacculitis
associated with E. coli susceptible to florfenicol.
SWINE: Florfen 10% w/v oral solution is indicated for the treatment of
swine respiratory disease associated with Actinobacillus
pleuropneumoniae and Pasteurella multocida.
DIRECTIONS FOR USE:
For Broiler Chickens: 100 ppm (100 mg/mL) for 3