Procapen, 300 mg/ml, Suspension for injection for cattle, pigs and horses

Χώρα: Ουγγαρία

Γλώσσα: Αγγλικά

Πηγή: HMA (Heads of Medicines Agencies)

Δραστική ουσία:

benzylpenicillin procain salt 300 mg/ml

Διαθέσιμο από:

aniMedica GmbH

Φαρμακολογική κατηγορία (ATC):

QJ01CE09

Φαρμακοτεχνική μορφή:

Suspension for injection

Θεραπευτική ομάδα:

procaine penicillin

Θεραπευτική περιοχή:

Cattle Food, Horses Food, Pigs Food

Ημερομηνία της άδειας:

2010-04-16

Αρχείο Π.Χ.Π.

ANIMEDICA GMBH 
Procapen 

Procapen EN 
SmPC 
VA additional pack size 
DE/V/0126/001/DC Version: 16.04.2010, ID 

approved: 16.04.2010  
1 von 7 

_ [Version Final] _

SUMMARY OF PRODUCT CHARACTERISTICS 

ANIMEDICA GMBH 
Procapen 

Procapen EN 
SmPC 
VA additional pack size 
DE/V/0126/001/DC Version: 16.04.2010, ID 

approved: 16.04.2010  
2 von 7 

1. 
NAME OF THE VETERINARY MEDICINAL PRODUCT 
Procapen, 300 mg/ml, Suspension for injection for cattle, pigs and
horses 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
1 ml suspension for injection contains 
ACTIVE SUBSTANCE: 
Benzylpenicillin, procaine 1 H
2
O 300.00 
mg 
EXCIPIENTS: 
Methyl-4-hydroxy benzoate (E 218)  2.84 mg 
Propyl-4-hydroxy benzoate (E 216) 
0.32 mg 
EXCIPIENT(S): 
For a full list of excipients, see section 6.1. 
3. PHARMACEUTICAL 
FORM 
Suspension for injection 
White to yellowish suspension 
4. CLINICAL 
PARTICULARS 
4.1 TARGET 
SPECIES 
Cattle, pigs (adult pigs) and horses 
4.2 
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 
For the treatment of bacterial infectious diseases, caused
by Benzylpenicillin sensitive pathogens. 
CATTLE, CALVES, AND HORSES: 
General bacterial infections (septicaemias) 
Primary and secondary infections of the 
-  respiratory system  
-  urinary and genital apparatus 
-  skin and the claws 
-  joints 
PIGS (ADULT PIGS): 
Primary and secondary infections of the 
-  urogenitary tract (infections with ß-haemolytic Streptococcus
spp.) 
-  musculoskeletal system (infections with Streptococcus suis) 
-  skin (infections with Erysipelotrix rhusiopathiae) 

The use should be based on the result of an antibiogram. 
4.3 CONTRAINDICATIONS 
Do not use in case of: 
-  resistance against Penicillins  
-  infections with ß-lactamase producing pathogens  
-  hypersensitivity to Penicillins or Cephalosporins, Procain or
against a