Veterinary Medicines

Calcibel Forte, 380/60/50mg/ml, Solution for infusion

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

Medicine name:
Calcibel Forte, 380/60/50mg/ml, Solution for infusion
Calcibel Forte 380+60+50 mg/ml infusionsvæske, opløsning
Active substance:
  • Calcium gluconate
  • Magnesium chloride hexahydrate
  • Boric acid
Target species:
  • Horse
  • Cattle
  • Sheep
  • Goat
  • Pig
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Calcium gluconate
    380.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium chloride hexahydrate
    60.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Boric acid
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for infusion
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Cattle
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Sheep
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Goat
      • Milk
        0
        hour
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12AX
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Plastic Bottle 12 x 500.0 millilitre(s)
  • Plastic Bottle 1 x 500.0 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) 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:
  • Danish Health And Medicines Authority
Authorisation number:
  • 65044
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0170/001
Concerned member states:
  • Austria
  • Cyprus
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • 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.
Danish (PDF)
Published on: 29/06/2023
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