Flumequine 200 gL Oral Liquid

Country: Malaysia

Language: English

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

Active ingredient:

Flumequine Sodium

Available from:

Nam Pharma Sdn. Bhd.

INN (International Name):

Flumequine Sodium

Units in package:

500.00 mcg/mL; 1.00 mcg/mL

Manufactured by:

Nam Pharma Sdn. Bhd.

Summary of Product characteristics

FLUMEQUINE 200 g/L Oral Liquid
FLUMEQUINE 200 appears to be a dark yellow or yellow solution.
COMPOSITION:
Each Litre contains
Flumequine (as sodium)
200 g
PHARMACODYNAMICS:
Flumequine is active against Gram (-) bacteria.
Flumequine is a synthetic antibacterial agent which belongs to the
Quinolone family. It is the first fluorinated quinolone, with a
fluorinate atom which enhances its intrinsic activity and
antibacterial
spectrum.
It acts on nucleic acids by stopping DNA replication of the bacteria.
The exact molecular target is the DNA gyrase enzyme involved in
the DNA spiral formation. Antibacterial activity of Flumequine is the
result of the combination of bacterial cell penetration and DNA
gyrase-inhibiting activities.
PHARMACOKINETICS:
ABSORPTION AND DISTRIBUTION
Flumequine is well absorbed. Its bio-availability factor approximates
70 - 75%. Tmax is reached after more or less 13 - 14 h and Cmax
varies from 1.7 to 3.7 mg/l. Pharmacokinetic parameters are linearly
related to the administered dose of flumequine.
No accumulation in blood and no enzymatic induction or inhibition
are noticed.
BIOTRANSFORMATION
Flumequine is essentially metabolised into 7-hydroxyfumequine in
the kidney.
ELIMINATION
Flumequine has a relatively slow elimination phase. Its half-life
approximates 5 - 6 hours.
Flumequine is mainly excreted via urine
INDICATIONS:
In poultry: Curative and preventive treatment in respiratory,
digestive and septicemic infections caused by Escherichia coli,
Salmonella sp and Pasteurella sp.
DIRECTIONS FOR USE:
In poultry: 12 mg flumequine per kg body weight per day for 5 days
orally. The amount of medicated drinking water consumed by the
animals depends on their physiological and clinical status. To obtain
the recommended dosage, the concentration of flumequine must be
adjusted accordingly.
MODE OF ADMINISTRATION: Oral Liquid.
CONTRAINDICATION:
Do not use in laying hens producing eggs for human consumption.
SYMPTOMS AND TREATMENT OF OVERDOSE
Poultry: No side effects were observed during the tolerance studies