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 ISO B. Braun Vet Care Soluzione per infusione per bovini, cavalli, pecore, capre, suini, cani e gatti
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:
  • Italy
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:
  • European Medicines Agency
Authorisation number:
  • 105912
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