Veterinary Medicines

Calmasol-440, solution for infusion for cattle, sheep and pigs

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

Medicine name:
Calmasol-440, solution for infusion for cattle, sheep and pigs
Calmafusion 380mg/60mg/50mg, otopina za infuziju, za goveda, ovce i svinje
Active substance:
  • Calcium gluconate monohydrate
  • Magnesium chloride hexahydrate
  • Boric acid
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Calcium gluconate monohydrate
    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
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • 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:
  • Croatia
Package description:
  • Graduated polypropylene bottle, closed with a bromobutyl rubber stopper and secured with an aluminium cap. 12x500 ml.
  • Graduated polypropylene bottle, closed with a bromobutyl rubber stopper and secured with an aluminium cap. 1x500 ml.

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:
  • Interchemie Werken De Adelaar Eesti AS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Interchemie Werken De Adelaar Eesti AS
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/19-01/694
Date of authorisation status change:
Reference member state:
  • Estonia
Procedure number:
  • EE/V/0104/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 18/02/2025
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