BAYTRIL MAX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

ENROFLOXACIN

제공처:

Bayer Limited

ATC 코드:

QJ01MA90

INN (International Name):

ENROFLOXACIN

복용량:

100 Mg/Ml

약제 형태:

Solution for Injection

처방전 유형:

POM

치료 그룹:

Bovine, Porcine

치료 영역:

Enrofloxacin

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2012-11-23

제품 특성 요약

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
EXCIPIENT(S):
n-Butanol
30 mg
Benzyl alcohol (E 1519)
20 mg
For a 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 secondary pathogen in pigs.
4.3 CONTRAINDICATIONS
Do not use in the presence of documented hypersensitivity to the pharmacologically active ingredient or to any of the
other ingredients. 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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in case of resistance against other fluoroquinolone due to the potential for cross-resistance.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/11/2012_
_CRN 7011798_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For repeated