Ubropen 600 mg intramammary suspension for lactating cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benzylpenicillin procaine monohydrate

Available from:

Vetcare Oy

ATC code:

QJ51CE09

INN (International Name):

Benzylpenicillin procaine monohydrate

Dosage:

600 mg/syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

procaine benzylpenicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

Health Products Regulatory Authority
19 February 2021
CRN009WDR
Page 1 of 5
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
​
600mg
(equivalent to benzylpenicillin 340.8mg)
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.
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 to the potential