Veterinary Medicines

Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs

Authorised
  • Magnesium chloride hexahydrate
  • Calcium gluconate
  • Boric acid
Download as PDF

Product identification

Medicine name:
Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs
Calcibel 240/60/60 mg/ml raztopina za infundiranje za konje, govedo, ovce, koze in prašiče
Active substance:
  • Magnesium chloride hexahydrate
  • Calcium gluconate
  • Boric acid
Target species:
  • Cattle
  • Goat (adult female)
  • Sheep
  • Horse
  • Pig
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Magnesium chloride hexahydrate
    60.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Calcium gluconate
    240.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Boric acid
    60.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
    • Goat (adult female)
    • Sheep
    • Horse
    • Pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12AX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • Bottle for infusion made of polypropylene with scaling, closures made of bromobutyl rubber stopper, aluminium caps with tear-off. Pack size 6 x 500 ml.
  • Bottle for infusion made of polypropylene with scaling, closures made of bromobutyl rubber stopper, aluminium caps with tear-off. Pack size 12 x 500 ml.
  • Bottle for infusion made of polypropylene with scaling, closures made of bromobutyl rubber stopper, aluminium caps with tear-off. Pack size 1 x 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:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • JAZMP
Authorisation number:
  • DC/V/0527/001
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0197/001
Concerned member states:
  • Austria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • Greece
  • Hungary
  • Ireland
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
Download

Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 11/04/2022
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."