Veterinary Medicines

Kaltetan, 250 mg/ml + 80 mg/ml + 10 mg/ml solution for infusion for horses, cattle and pigs

Authorised
  • CALCIUM GLUCONATE FOR INJECTION
  • Magnesium chloride hexahydrate
  • Sodium glycerophosphate pentahydrate
Download as PDF

Product identification

Medicine name:
Kaltetan, 250 mg/ml + 80 mg/ml + 10 mg/ml solution for infusion for horses, cattle and pigs
Kaltetan, 250+80+10mg/ml, Injekční roztok
Active substance:
  • CALCIUM GLUCONATE FOR INJECTION
  • Magnesium chloride hexahydrate
  • Sodium glycerophosphate pentahydrate
Target species:
  • Horse
  • Pig
  • Cattle
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • CALCIUM GLUCONATE FOR INJECTION
    250.00
    milligram(s)/millilitre
    /
    1.00
    milligram(s)/millilitre
  • Magnesium chloride hexahydrate
    80.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sodium glycerophosphate pentahydrate
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Milk
        5
        week
    • Pig
      • Meat and offal
        5
        week
    • Cattle
      • Milk
        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:
  • Czechia
Available in:
  • Czechia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/002/22-C
Date of authorisation status change:
Reference member state:
  • Poland
Procedure number:
  • PL/V/0110/001
Concerned member states:
  • Bulgaria
  • Czechia
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Portugal
  • Romania
  • Spain

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 25/10/2022
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."