HIPRALONA ENRO-I (Enrofloxacin 50 mgml solution for injection for cattle and swine)

Country: Malaysia

Language: English

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

Active ingredient:

ENROFLOXACIN

Available from:

Hipra Malaysia Sdn Bhd

INN (International Name):

ENROFLOXACIN

Units in package:

100.00 mcg/mL

Manufactured by:

Laboratorios Hipra, S.A.

Summary of Product characteristics

705356-02.1
02-18
HIPRALONA ENRO-I
Enrofloxacin 50 mg/ml solution for injection for cattle and
swine
COMPOSITION PER ML:
Enrofloxacin 50 mg.
Clear solution slightly yellowish.
Enrofloxacin
is
a
broad-spectrum
antibacterial,
belonging to the fluoroquinolone family. It acts by
inhibiting DNA replication, by inhibiting bacterial
DNAgyrase and topoisomerase IV.
It is bactericidal at very low concentrations. It is
active against Gram-negative bacteria (_Escherichia _
_coli, Salmonella sp, Pasteurella sp, Klebsiella sp, _
_Haemophilus _
_sp, _
_Pseudomonas _
_sp_),
some
Grampositive bacteria and _Mycoplasma_.
It is rapidly absorbed after administration by subcutaneous route,
reaching
maximum concentrations between 30 minutes and 2 hours after injection.
It
presents a high volume of distribution and an optimum tissue
penetration,
reaching very high tissue concentrations. The serum and tissue
concentrations
of
enroflaxacin
are
much
higher
than
the
MIC/MBC
of
most
sensitive
microorganisms; therapeutically effective levels are maintained for 24
hours.
ADMINISTRATION ROUTE:
Swine: Intramuscular Injection.
Bovine: Subcutaneous Injection.
DOSAGE:
Cattle: 2.5 mg enrofloxacin per kg bodyweight (0.5 ml/10 kg) daily for
3 days.
This rate may be doubled to 5 mg enrofloxacin per kg bodyweight (1.0
ml/10
kg) for 5 days for salmonellosis and complicated respiratory diseases.
Not more than 10 ml should be administered at the one subcutaneous
injection site.
Pigs: 2.5 mg enrofloxacin per kg bodyweight (0.5 ml/10 kg) daily for 3
days.
This rate may be doubled to 5 mg enrofloxacin per kg bodyweight (1.0
ml/10
kg) for 5 days for salmonellosis and complicated respiratory diseases.
Not more than 2.5 ml should be administered at the one intramuscular
site.
INDICATIONS:
Cattle: Diseases of the respiratory and alimentary tract of bacterial
or
mycoplasmalnorigin
(e.g.
pasteurellosis,
mycoplasmosis,
coli-bacillosis,
coli-septicaemia
and
salmonellosis)
and
secondary
bacterial
infections
subsequent
to
viral
conditions
(e.g.
viral
pneumonia),
where