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Bacolam Injectable (100 mg + 250000 IU)/ml Zawiesina do wstrzykiwań

Authorised
  • Amoxicillin trihydrate
  • COLISTIN SULFATE
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Product identification

Medicine name:
Bacolam Injectable (100 mg + 250000 IU)/ml Zawiesina do wstrzykiwań
Active substance:
  • Amoxicillin trihydrate
  • COLISTIN SULFATE
Target species:
  • Pig
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Amoxicillin trihydrate
    114.80
    milligram(s)
    /
    1.00
    millilitre(s)
  • COLISTIN SULFATE
    250000.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        10
        day
    • Cattle
      • Meat and offal
        24
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01RA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Available in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 1098
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
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