Veterinary Medicines

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

Authorised
  • Boric acid
  • Calcium gluconate
  • Magnesium chloride hexahydrate
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Product identification

Medicine name:
Calcibel 240/60/60 mg/ml solution for infusion for horses, cattle, sheep, goats and pigs
Calcibel 240 mg/ml + 60 mg/ml + 60 mg/ml Roztwór do infuzji
Active substance:
  • Boric acid
  • Calcium gluconate
  • Magnesium chloride hexahydrate
Target species:
  • Cattle
  • Goat (adult female)
  • Sheep
  • Horse
  • Pig
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Boric acid
    60.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Calcium gluconate
    240.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium chloride hexahydrate
    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:
  • Poland
Available in:
  • Poland
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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2615
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.
Polish (PDF)
Published on: 6/02/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 6/02/2023
Download
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