ENROTRON FLAVOUR 50 MG TABLET

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

ENROFLOXACIN

Disponibil de la:

My Vet Care Sdn Bhd

INN (nume internaţional):

ENROFLOXACIN

Unități în pachet:

100 Tablets; 50 Tablets

Produs de:

LelyPharma B. V.

Caracteristicilor produsului

ENROTRON FLAVOUR 50 MG
Enrofloxacin
Tablets
B. PACKAGE LEAFLET
ENROTRON FLAVOUR 50 MG
Enrofloxacin
Tablets
PACKAGE LEAFLET FOR:
ENROTRON FLAVOUR 50 MG, tablets for dogs
1.
NAME
AND
ADDRESS
OF
THE
MARKETING
AUTHORISATION
HOLDER AND OF THE MANUFACTURER
Name and address of the manufacturer
LelyPharma B. V.
Zuiveringweg 42
8243 PZ Lelystad
The Netherlands
Marketing authorisation holder:
My Vet Care Sdn. Bhd.
A-G-3A, Red Ruby Shop Apartment
Jalan Indah 2/4, Taman Universiti Indah
43300 Seri Kembangan
Selangor, Malaysia
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENROTRON FLAVOUR 50 MG, tablets
Enrofloxacin
3.
STATEMENT
OF
THE
ACTIVE
SUBSTANCE
AND
OTHER
INGREDIENTS
1 tablet contains:
ACTIVE SUBSTANCE:
Enrofloxacin ...................... 50.0 mg
White to off-white, round tablet with one break line and one
decorative line. The
tablet can be divided into two equal parts.
ENROTRON FLAVOUR 50 MG
Enrofloxacin
Tablets
4.
INDICATIONS
For the treatment of bacterial single or combined infections of the
respiratory,
alimentary or urinary tract, the skin or wounds, caused by
enrofloxacin-sensitive
Gram-negative
and
Gram-positive
bacteria:
_E. _
_coli_,
_Pasteurella_
spp.,
_Haemophilus_ spp. and staphylococci.
5.
CONTRAINDICATIONS
Do not use in young or growing dogs (dogs aged less than 12 months
(small
breed) or less than 18 months (large breed)) as the product may cause
epiphyseal cartilage alterations in growing puppies.
Do not use in dogs having seizure disorders, since enrofloxacin may
cause
CNS stimulation.
Do not use in dogs with known hypersensitivity to fluoroquinolones or
to any of
the excipients of the product.
Do not use in case of resistance to quinolones, as there exists almost
complete
cross resistance to other quinolones and complete cross resistance to
other
fluoroquinolones.
Do not use with tetracyclines, phenicols or macrolides because of
potential
antagonistic effects.
See also section “Special warnings”.
6.
ADVERSE REACTIONS
In rare cases, vomiting and diarrhoea are observed.
See section “Contraindication