Veterinary Medicines

Sterofundin ISO B. Braun Vet Care Solution for infusion for cattle, horse, sheep, goat, pig, dog and cat

Authorised
  • L-malic acid
  • Sodium acetate trihydrate
  • Calcium chloride dihydrate
  • Magnesium chloride hexahydrate
  • Potassium chloride
  • Sodium chloride
Download as PDF

Product identification

Medicine name:
Sterofundin ISO B. Braun Vet Care Solution for infusion for cattle, horse, sheep, goat, pig, dog and cat
Sterofundin ISO B. Braun Vet Care Infusionslösung für Rinder, Pferde, Schafe, Ziegen, Schweine, Hunde und Katzen
Active substance:
  • L-malic acid
  • Sodium acetate trihydrate
  • Calcium chloride dihydrate
  • Magnesium chloride hexahydrate
  • Potassium chloride
  • Sodium chloride
Target species:
  • Cattle
  • Dog
  • Goat
  • Sheep
  • Horse
  • Cat
  • Pig
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • L-malic acid
    0.67
    gram(s)
    /
    1000.00
    millilitre(s)
  • Sodium acetate trihydrate
    3.27
    gram(s)
    /
    1000.00
    millilitre(s)
  • Calcium chloride dihydrate
    0.37
    gram(s)
    /
    1000.00
    millilitre(s)
  • Magnesium chloride hexahydrate
    0.20
    gram(s)
    /
    1000.00
    millilitre(s)
  • Potassium chloride
    0.30
    gram(s)
    /
    1000.00
    millilitre(s)
  • Sodium chloride
    6.80
    gram(s)
    /
    1000.00
    millilitre(s)
Pharmaceutical form:
  • Solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Dog
    • Goat
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Cat
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB05BB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • (ID3): 1 unspecified outer container with 10 Bottle (Low Density PolyEthylene) with 1000 millilitre(s) (10000 millilitre(s))
  • (ID2): 1 unspecified outer container with 10 Bottle (Low Density PolyEthylene) with 500 millilitre(s) (5000 millilitre(s))
  • (ID1): 1 unspecified outer container with 10 Bottle (Low Density PolyEthylene) with 250 millilitre(s) (2500 millilitre(s))

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
  • B. Braun Melsungen AG
Marketing authorisation date:
Manufacturing sites for batch release:
  • B.Braun Medical S.A.
  • B. Braun Melsungen AG
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 402582.00.00
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0193/001
Concerned member states:
  • Austria
  • Portugal
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 21/06/2023
Updated on: 26/06/2023
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."