Baytril Max 100 mg/ml Solution for Injection for Cattle and 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:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2012-11-13

Summary of Product characteristics

Revised: September 2020
AN: 00778/2020 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Direct 100 mg/ml Injektionslösung für Rinder und Schweine
[AT]
Baytril Inject – Soluzione iniettabile 100mg/ml per bovini e suini
[IT]
Baytril XM 100 mg/mL Solution injectable pour bovins et porcs [FR]
Baytril 1nject 100 mg/ml Injektionslösung für Rinder und Schweine
[DE]
Baytril Max 100 mg/ml Solution for Injection for Cattle and Pigs [IE,
UK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENTS:
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
Cattle, Pig
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
For the treatment of respiratory tract infections caused by
enrofloxacin-sensitive
_Histophilus _
_somni,_
_ _
_Mannheimia _
_haemolytica,_
_ _
_Pasteurella _
_multocida_
_ _and
_Mycoplasma _spp.
For the treatment of mastitis caused by enrofloxacin-sensitive _E.
coli_.
Pig:
For the treatment of bacterial bronchopneumonia caused by
enrofloxacin-sensitive
_Actinobacillus pleuropneumoniae_,
_Pasteurella multocida_
and complicated by
_Haemophilus parasuis _as a secondary pathogen_ _in pigs._ _
Page 1 of 8
Revised: September 2020
AN: 00778/2020
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 known cases of resistance to other
(fluoro)quinolones 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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
For repeated inj