Ubropen 600 mg Intramammary Suspension for Lactating Cows

Summary of Product characteristics

                                Revised: April 2021
AN: 00667/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubropen 600 mg intramammary suspension for lactating cows
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 g intramammary syringe contains:
ACTIVE SUBSTANCE:
Benzylpenicillin procaine monohydrate 600 mg
(equivalent to 340.8 mg benzylpenicillin)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension.
White to yellowish, oily suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (lactating cow).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical mastitis caused by penicillin susceptible
streptococci or
staphylococci occurring during the lactation phase.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances, to
substances of the
β-lactam group or to any of the excipients.
Do not use in cases of infections with β-lactamase-forming pathogens.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
If the product is used in treatment of mastitis caused by
_Staphylococcus aureus_, an
appropriate parenteral antimicrobial may be required.
Revised: April 2021
AN: 00667/2020
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on identification and
susceptibility testing of the
bacteria isolated from the animal. If this is not possible, therapy
should be based on
local (regional, farm level) epidemiological information about
susceptibility of the
target bacteria. Official, national and regional antimicrobial
policies should be taken
into account when the product is used. In some geographical areas or
in some
individual herds resistance to penicillin in _S. aureus_ is
widespread.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to benzylpenicillin and may decrease
the
effectiveness of treatment with other beta lactam antimicrobials
(penicillins and
cephalosporins) due 
                                
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