BAYTRIL MAX 100 MG/ML SOLUTION FOR INJECTION FOR PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-07-2016
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Active ingredient:
ENROFLOXACIN
Available from:
Bayer Limited
ATC code:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Porcine
Therapeutic area:
Enrofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2011-09-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Max 100 mg/ml solution for injection for 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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Clear, yellow solution for injection.
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 08/07/2016_
_CRN 7022663_
_page number: 1_
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 respo
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