Veterinary Medicines

Calciject 40 Solution for Injection

Authorised
  • Calcium borogluconate
  • Boric acid
Download as PDF

Product identification

Medicine name:
Calciject 40 Solution for Injection
Active substance:
  • Calcium borogluconate
  • Boric acid
Target species:
  • Cattle
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Calcium borogluconate
    400.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Boric acid
    68.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12A
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Available in:
  • Ireland
Package description:
  • 400 ml polypropylene container with bromobutyl bung (grey) and aluminium cap.
  • *HISTORICAL* 400 ml Type III glass vial (amber) sealed with rubber wad (black) and aluminium screw cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Council Directive 81/851/EEC
Marketing authorisation holder:
  • Norbrook Laboratories (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Norbrook Laboratories Limited
  • Norbrook Manufacturing Ltd
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22664/031/001
Date of authorisation status change:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 1/12/2024
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."