Authorised

Product identification

Medicine name:
Kaltetan forte, 458.4 mg/ml + 125 mg/ml + 20 mg/ml solution for infusion for horses, cattle and pigs
Калтетан форте, 458,4 mg/ml + 125 mg/ml + 20 mg/ml инфузионен разтвор за коне
Active substance:
  • CALCIUM GLUCONATE FOR INJECTION
  • Magnesium chloride hexahydrate
  • Sodium glycerophosphate pentahydrate
Target species:
  • Horse
  • Cattle
  • Pig
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • CALCIUM GLUCONATE FOR INJECTION
    458.40
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium chloride hexahydrate
    125.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sodium glycerophosphate pentahydrate
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Milk
        5
        week
    • Cattle
      • Meat and offal
        5
        week
    • Pig
      • Meat and offal
        5
        week
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12AX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • Polypropylene (PP) bottles closed with a bromobutyl rubber stopper, type I and secured with an aluminium cap. Package size: 500 ml

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:
  • Vet-Agro Multi-Trade Company Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Przedsiebiorstwo Wielobranzowe Vet-Agro Sp. z o.o.
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-3110
Date of authorisation status change:
Reference member state:
  • Poland
Procedure number:
  • PL/V/0110/002
Concerned member states:
  • Bulgaria
  • Czechia
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Portugal
  • Romania
  • Spain

Documents

Summary of Product Characteristics

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Bulgarian (PDF)
Published on: 21/07/2022
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Source URL: https://medicines.health.europa.eu/veterinary/600000092613