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

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Enrofloxacin

Dostopno od:

Elanco GmbH

Koda artikla:

QJ01MA90

INN (mednarodno ime):

Enrofloxacin

Odmerek:

100 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

enrofloxacin

Status dovoljenje:

Authorised

Datum dovoljenje:

2012-11-23

Lastnosti izdelka

Health Products Regulatory Authority
16 October 2020
CRN009PP1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Max 100 mg/ml Solution for Injection for Cattle and Pigs
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.
Health Products Regulatory Authority
16 October 2020
CRN009PP1
Page 2 of 6
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 injection or for injection volumes exceeding 15 ml
(cattle) or 7.5 ml (pigs, calves) in divided doses, a new site must
be chosen for each injection.
Official and local antimicrobial policies should be taken into account
when the product is used.
Fluoroquinolones should b