Veterinary Medicines

Calciolab 216.18/60/51 mg/ml solution for infusion

Authorised
  • Calcium gluconate
  • Magnesium chloride hexahydrate
  • Magnesium hypophosphite hexahydrate
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Product identification

Medicine name:
Calciolab 216.18/60/51 mg/ml solution for infusion
Calciolab, 216,18/60/51 mg/ml infusioonilahus
Active substance:
  • Calcium gluconate
  • Magnesium chloride hexahydrate
  • Magnesium hypophosphite hexahydrate
Target species:
  • Cattle
  • Sheep
  • Goat
  • Pig
  • Horse
  • Dog
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Calcium gluconate
    216.18
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium chloride hexahydrate
    60.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium hypophosphite hexahydrate
    51.00
    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
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA12
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Estonia
Package description:
  • Polypropylene bottles with chlorobutyl rubber stopper and aluminium cap. Box with 1 bottle of 100 ml.
  • Polypropylene bottles with chlorobutyl rubber stopper and aluminium cap. Bottle of 500 ml.
  • Polypropylene bottles with chlorobutyl rubber stopper and aluminium cap. Box with 10 bottles of 100 ml.
  • Polypropylene bottles with chlorobutyl rubber stopper and aluminium cap. Box with 6 bottles of 500 ml.
  • Polypropylene bottles with chlorobutyl rubber stopper and aluminium cap. Box with 12 bottles of 500 ml.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • LABIANA LIFE SCIENCES, S.A.
Responsible authority:
  • State Agency Of Medicines
Authorisation number:
  • 1171424
Date of authorisation status change:
Reference member state:
  • Estonia
Procedure number:
  • EE/V/0107/001
Concerned member states:
  • Bulgaria
  • Czechia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Slovakia
Generic of:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Estonian (PDF)
Published on: 12/09/2024
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