Veterinary Medicines

DUPHALYTE, Injekční roztok

Authorised
  • Riboflavin sodium phosphate dihydrate
  • L-ISOLEUCINE
  • Leucine
  • Lysine hydrochloride
  • Methionine
  • Panthenol
  • L-THREONINE
  • Arginine hydrochloride
  • Calcium chloride hexahydrate
  • Magnesium sulfate
  • Glucose
  • Histidine hydrochloride monohydrate
  • Cyanocobalamin
  • Thiamine hydrochloride
  • Pyridoxine hydrochloride
  • Nicotinamide
  • Cysteine hydrochloride monohydrate
  • Monosodium glutamate
  • PHENYLALANINE DL
  • DL-Valine
  • DL-Tryptophan
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Product identification

Medicine name:
DUPHALYTE, Injekční roztok
Active substance:
  • Riboflavin sodium phosphate dihydrate
  • L-ISOLEUCINE
  • Leucine
  • Lysine hydrochloride
  • Methionine
  • Panthenol
  • L-THREONINE
  • Arginine hydrochloride
  • Calcium chloride hexahydrate
  • Magnesium sulfate
  • Glucose
  • Histidine hydrochloride monohydrate
  • Cyanocobalamin
  • Thiamine hydrochloride
  • Pyridoxine hydrochloride
  • Nicotinamide
  • Cysteine hydrochloride monohydrate
  • Monosodium glutamate
  • PHENYLALANINE DL
  • DL-Valine
  • DL-Tryptophan
Target species:
  • Cat
  • Horse
  • Pig
  • Cattle
  • Dog
  • Chicken
Route of administration:
  • Intravenous use
  • Subcutaneous use
  • Intraperitoneal use

Product details

Active substance and strength:
  • Riboflavin sodium phosphate dihydrate
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-ISOLEUCINE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • Leucine
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Lysine hydrochloride
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • Methionine
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • Panthenol
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-THREONINE
    0.02
    milligram(s)
    /
    1.00
    millilitre(s)
  • Arginine hydrochloride
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • Calcium chloride hexahydrate
    0.23
    milligram(s)
    /
    1.00
    millilitre(s)
  • Magnesium sulfate
    0.29
    milligram(s)
    /
    1.00
    millilitre(s)
  • Glucose
    45.56
    milligram(s)
    /
    1.00
    millilitre(s)
  • Histidine hydrochloride monohydrate
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • Cyanocobalamin
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
  • Thiamine hydrochloride
    0.10
    milligram(s)
    /
    1.00
    millilitre(s)
  • Pyridoxine hydrochloride
    0.10
    milligram(s)
    /
    1.00
    millilitre(s)
  • Nicotinamide
    1.50
    milligram(s)
    /
    1.00
    millilitre(s)
  • Cysteine hydrochloride monohydrate
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • Monosodium glutamate
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • PHENYLALANINE DL
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • DL-Valine
    0.05
    milligram(s)
    /
    1.00
    millilitre(s)
  • DL-Tryptophan
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
  • Subcutaneous use
    • Pig
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Chicken
      • Meat and offal
        0
        day
  • Intraperitoneal use
    • Pig
      • Meat and offal
        0
        day
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA11AA03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Available in:
  • Czechia
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Ceska Republika s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/535/94-C
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Czech (PDF)
Published on: 26/10/2022
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Package Leaflet

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Czech (PDF)
Published on: 26/10/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 26/10/2022
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