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
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Product identification

Medicine name:
Sterofundin ISO B. Braun Vet Care Solution for infusion for cattle, horse, sheep, goat, pig, dog and cat
Sterofundin Vet. infusionsvæske, opløsning
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
    • 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
    • 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:
  • Denmark
Package description:
  • (ID3) 10000 millilitre(s): unspecified outer container with 10 Bottle (low-density polyethylene) each with 1000 millilitre(s), closed with (PolyethylenhoherDichte)
  • (ID2) 5000 millilitre(s): unspecified outer container with 10 Bottle (low-density polyethylene) each with 500 millilitre(s), closed with (PolyethylenhoherDichte)
  • (ID1) 2500 millilitre(s): unspecified outer container with 10 Bottle (low-density polyethylene) each with 250 millilitre(s), closed with (PolyethylenhoherDichte)

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:
  • Danish Medicines Agency
Authorisation number:
  • 73128
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0193/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • France
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 2/12/2025
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