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

国家: 西班牙

语言: 英文

来源: HMA (Heads of Medicines Agencies)

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产品特点 产品特点 (SPC)
21-08-2013

有效成分:

benzylpenicillin procain salt 300 mg/ml

可用日期:

aniMedica GmbH

ATC代码:

QJ01CE09

药物剂型:

Suspension for injection

治疗组:

procaine penicillin

治疗领域:

Cattle Food, Horses Food, Pigs Food

授权日期:

2010-04-16

产品特点

                                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
                                
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