Veterinary Medicines

NaCl Bernburg, 0,9%, Solution for injection/infusion

Authorised
  • Sodium chloride
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Product identification

Medicine name:
NaCl Bernburg, 0,9%, Solution for injection/infusion
NaCl Bernburg, 0,9%, Injekční/infuzní roztok
Active substance:
  • Sodium chloride
Target species:
  • Cattle
  • Horse
  • Sheep
  • Goat
  • Pig
  • Dog
  • Cat
  • Rabbit
  • Guinea pig
Route of administration:
  • Intravenous use
  • Subcutaneous use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Sodium chloride
    9.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection/infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
    • Dog
    • Cat
    • Rabbit
      • Meat and offal
        0
        day
    • Guinea pig
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
    • Dog
    • Cat
    • Rabbit
      • Meat and offal
        0
        day
    • Guinea pig
  • Intraperitoneal use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
    • Dog
    • Cat
    • Rabbit
      • Meat and offal
        0
        day
    • Guinea pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB05BB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Plastic (PP) Bottle 1 x 500.0 millilitre(s)
  • Plastic (PP) Bottle 10 x 500.0 millilitre(s)
  • Plastic (PP) Bottle 20 x 500.0 millilitre(s)
  • Plastic Bottle 1 x 5000.0 millilitre(s)
  • Plastic Bottle 2 x 5000.0 millilitre(s)
  • Plastic (PE) Bottle 10 x 1000.0 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Serumwerk Bernburg AG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Serumwerk Bernburg AG
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/024/22-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0175/001
Concerned member states:
  • Germany

Documents

Summary of Product Characteristics

English (PDF)
Published on: 2/10/2025
Download
Czech (PDF)
Published on: 11/10/2024
Download

Package Leaflet

English (PDF)
Published on: 2/10/2025
Download
Czech (PDF)
Published on: 11/10/2024
Download

Labelling

English (PDF)
Published on: 2/10/2025
Download
Czech (PDF)
Published on: 11/10/2024
Download

eu-puar-czv0175001-mr-nacl_bernburg-en.pdf

English (PDF)
Published on: 16/11/2023
Download
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