Baytril Max 100 mg/ml Solution for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enrofloxacin

Available from:

Bayer plc

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2011-09-05

Summary of Product characteristics

Revised: July 2016
AN: 01357/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Direct 100 mg/ml Injektionslösung für Schweine [AT]
Baytril 1nject 100 mg/ml solution for injection for pigs
[BE, LU, NL] Baytril Inject – Soluzione iniettabile
100mg/ml per suini [IT]
Baytril Max 100 mg/ml solution for injection for pigs [IE, UK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT(S):
n-Butanol
30 mg
Benzyl alcohol (E 1519) 20 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
Pig
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial bronchopneumonia caused by
enrofloxacin-
sensitive _Actinobacillus pleuropneumoniae_, _Pasteurella multocida
_and
complicated by _Haemophilus parasuis _as secondary pathogen in pigs.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients. Do not use in case of resistance against other
fluoroquinolone due to the
potential for cross-resistance.
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. Do
not use for prophylaxis.
Revised: July 2016
AN: 01357/2015
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Repeated injections should be administered at different sites.
Official, national and regional 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 only be used based on
su