Veterinary Medicines

DUPHALYTE

Authorised
  • L-HISTIDINE
  • Arginine
  • L-METHIONINE
  • L-ISOLEUCINE
  • L-LEUCINE
  • Sodium glutamate
  • L-CYSTEINE
  • L-THREONINE
  • MAGNESIUM SULPHATE ANHYDROUS
  • Riboflavin
  • Potassium chloride
  • Dexpanthenol
  • Thiamine
  • Nicotinamide
  • Calcium chloride hexahydrate
  • Cyanocobalamin
  • PHENYLALANINE DL
  • Pyridoxine
  • L-lysine hydrochloride
  • DL-Tryptophan
  • Glucose
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Product identification

Medicine name:
DUPHALYTE
Active substance:
  • L-HISTIDINE
  • Arginine
  • L-METHIONINE
  • L-ISOLEUCINE
  • L-LEUCINE
  • Sodium glutamate
  • L-CYSTEINE
  • L-THREONINE
  • MAGNESIUM SULPHATE ANHYDROUS
  • Riboflavin
  • Potassium chloride
  • Dexpanthenol
  • Thiamine
  • Nicotinamide
  • Calcium chloride hexahydrate
  • Cyanocobalamin
  • PHENYLALANINE DL
  • Pyridoxine
  • L-lysine hydrochloride
  • DL-Tryptophan
  • Glucose
Target species:
  • Cattle
  • Cattle (calf)
  • Horse
  • Pig
  • Pig (piglet)
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • L-HISTIDINE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • Arginine
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-METHIONINE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-ISOLEUCINE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-LEUCINE
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sodium glutamate
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-CYSTEINE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-THREONINE
    0.02
    milligram(s)
    /
    1.00
    millilitre(s)
  • MAGNESIUM SULPHATE ANHYDROUS
    0.29
    milligram(s)
    /
    1.00
    millilitre(s)
  • Riboflavin
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Potassium chloride
    0.20
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dexpanthenol
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
  • Thiamine
    0.10
    milligram(s)
    /
    1.00
    millilitre(s)
  • Nicotinamide
    1.50
    milligram(s)
    /
    1.00
    millilitre(s)
  • Calcium chloride hexahydrate
    0.23
    milligram(s)
    /
    1.00
    millilitre(s)
  • Cyanocobalamin
    0.05
    microgram(s)
    /
    1.00
    millilitre(s)
  • PHENYLALANINE DL
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • Pyridoxine
    0.10
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-lysine hydrochloride
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • DL-Tryptophan
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • Glucose
    45.46
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Horse
      • Meat and offal
        0
        day
    • Pig
      • Meat and offal
        0
        day
    • Pig (piglet)
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Pig (piglet)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA11AA03
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Romania
Available in:
  • Romania
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Complete application (stand-alone) - Directive No 2001/82/EC
Marketing authorisation holder:
  • Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 170243
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 29/10/2021
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