Veterinary Medicines

Pendistrep, 200 mg/mL, 250 mg/mL, suspenzija za injekciju, za goveda, ovce, svinje i konje koji se ne koriste za hranu

Authorised
  • Benzylpenicillin procaine monohydrate
  • Dihydrostreptomycin sulfate
Download as PDF

Product identification

Medicine name:
Pendistrep, 200 mg/mL, 250 mg/mL, suspenzija za injekciju, za goveda, ovce, svinje i konje koji se ne koriste za hranu
Active substance:
  • Benzylpenicillin procaine monohydrate
  • Dihydrostreptomycin sulfate
Target species:
  • Cattle
  • Sheep
  • Pig
  • Horse (non food-producing)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Benzylpenicillin procaine monohydrate
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dihydrostreptomycin sulfate
    342.70
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        28
        day
      • Milk
        6
        day
    • Sheep
      • Meat and offal
        28
        day
      • Milk
        6
        day
    • Pig
      • Meat and offal
        28
        day
    • Horse (non food-producing)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.U.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/21-01/204
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Croatian (PDF)
Published on: 18/02/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."