Enrox Max 100 mg/ml Solution for Injection for Cattle and Pigs

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Enrofloxacin

Tersedia dari:

Krka d.d., Novo Mesto

Kode ATC:

QJ01MA90

INN (Nama Internasional):

Enrofloxacin

Bentuk farmasi:

Solution for injection

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Cattle, Pigs

Area terapi:

Antimicrobial

Status otorisasi:

Authorized

Tanggal Otorisasi:

2013-11-28

Karakteristik produk

Revised: July 2018
AN: 02164/2017
Page 1 of 6
SUMMARY OF PRODCUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrox Max 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100 mg
EXCIPIENTS:
Benzyl alcohol
(E1519)
20 mg
Butyl alcohol
30 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Cattle:
For the treatment of respiratory tract infections caused by
enrofloxacin-susceptible
_Histophilus somni, Mannheimia haemolytica, Pasteurella multocida,
_and _Mycoplasma_
spp. For the treatment of mastitis caused by enrofloxacin-susceptible
_E. coli_.
Pigs:
For the treatment of bacterial bronchopneumonia caused by
enrofloxacin-susceptible
_Actinobacillus pleuropneumoniae, Pasteurella multocida _and
complicated by
_Haemophilus parasuis _as secondary pathogen_ _in pigs.
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in animals with central nervous system-associated seizure
disorders. Do
not use in the presence of existing disorders of cartilage development
or
musculoskeletal damage around functionally significant or
weight-bearing joints.
Revised: July 2018
AN: 02164/2017
Page 2 of 6
Do not use in known cases of resistance against other
(fluoro)quinolones due to the
potential for cross-resistance.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account
when the
product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which
have responded poorly, or are expected to respond poorly, to other
classes of
antimicrobials.
Whenever possible, fluoroquinolones should o