Procapen Injector 3g intramammary suspension for cattle
Krajina: Portugalsko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
Príbalový leták
(PIL)
21-08-2013
Súhrn charakteristických
(SPC)
21-08-2013
Aktívna zložka:
procain -penicillin -G 300 mg/ml
Dostupné z:
aniMedica GmbH
ATC kód:
QJ01CE01
Forma lieku:
Intramammary suspension
Terapeutické skupiny:
benzylpenicillin
Terapeutické oblasti:
Cattle Females, Cattle Food
Dátum Autorizácia:
2012-03-16
Príbalový leták
Procapen Injector 3g
intramammary suspension for cattle
Final 16.03.2012
1
_[Version 7.3.1, 11/2010] _
SUMMARY OF PRODUCT CHARACTERISTICS
Procapen Injector 3g
intramammary suspension for cattle
Final 16.03.2012
2
SPC
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Procapen Injector 3g intramammary suspension for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml intramammary syringe contains:
ACTIVE SUBSTANCE :
Benzylpenicillin, procaine 1 H
2
O
3.0 g
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to yellowish intramammary suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dairy cow)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of udder infection in dairy cattle caused by benzylpenicillin-sensitive staphylococci and
streptococci.
4.3
CONTRAINDICATIONS
Do not use in the case of:
- penicillin resistance
- infections with β-lactamase-forming pathogens
- known hypersensitivity to penicillin, cephalosporins or procaine or one of the excipients of the product
- severe renal dysfunction with oliguria or anuria.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Care must be taken when applying the product in case of severe udder quarter swelling, milk duct
swelling and/or milk duct shifting due to congestion with detritus. Applications should be performed on
the basis of an antibiogram.
Inappropriate use of the product may increase the prevalence of the bacteria resistance to penicil
Prečítajte si celý dokument
Súhrn charakteristických
Procapen Injector 3g
intramammary suspension for cattle
Final 16.03.2012
1
_[Version 7.3.1, 11/2010] _
SUMMARY OF PRODUCT CHARACTERISTICS
Procapen Injector 3g
intramammary suspension for cattle
Final 16.03.2012
2
SPC
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Procapen Injector 3g intramammary suspension for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml intramammary syringe contains:
ACTIVE SUBSTANCE :
Benzylpenicillin, procaine 1 H
2
O
3.0 g
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to yellowish intramammary suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dairy cow)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of udder infection in dairy cattle caused by benzylpenicillin-sensitive staphylococci and
streptococci.
4.3
CONTRAINDICATIONS
Do not use in the case of:
- penicillin resistance
- infections with β-lactamase-forming pathogens
- known hypersensitivity to penicillin, cephalosporins or procaine or one of the excipients of the product
- severe renal dysfunction with oliguria or anuria.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Care must be taken when applying the product in case of severe udder quarter swelling, milk duct
swelling and/or milk duct shifting due to congestion with detritus. Applications should be performed on
the basis of an antibiogram.
Inappropriate use of the product may increase the prevalence of the bacteria resistance to penicil
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