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Baytril Max 100 mg/ml Solution for Injection for Pigs

Information leaflet

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                                                              Revised: February 2012
                                                                     AN: 01757/2011

                   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 1nject-10%, solution injectabile [FR]
     Baytril 1nject 100 mg/ml Injektionslösung für Schweine [DE]
     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           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

     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 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
                                          Page 1 of 6
                                                                 Revised: February 2012
                                                                        AN: 01757/2011

    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.

4.5 Special precautions for use

    i.     Special precautions for use in animals

           Repeated injections should be administered at different sites.
           Official and local 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
           susceptibility testing.
           Use of the product deviating from the instructions given in the SPC may
           increase the prevalence of bacteria resistant to the fluoroquinolones and may
           decrease the effectiveness of treatment with other quinolones due to the
           potential for cross resistance.
           Enrofloxacin is eliminated renally. As with all fluoroquinolones, delayed
           excretion can therefore be expected in the presence of existing renal
           damage.

    i i.   Special precautions to be taken by the person administering the veterinary
           medicinal product to animals

           People with known hypersensitivity to (fluoro)quinolones should avoid contact
           with the veterinary medicinal product.
           Direct contact with the skin should be avoided due to sensitisation, contact
           dermatitis and possible hypersensitivity reactions.
           Wash any splashes from skin or eyes immediately with water. Do not eat,
           drink or smoke while handling the product.
           Take care to avoid accidental self-injection. In case of accidental self-
           injection, seek medical advice immediately and show the package leaflet or
           label to the physician.

4.6 Adverse reactions (frequency and seriousness)

    In rare cases, transitory inflammatory reactions (swelling, redness) can occur at the
    injection site. These regress within a few days without further therapeutic
    measures.

4.7 Use during pregnancy, lactation or lay

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