Veterinary Medicines

DUPHALYTE

Authorised
  • Thiamine hydrochloride
  • RIBOFLAVIN SODIUM PHOSPHATE
  • Pyridoxine hydrochloride
  • Cyanocobalamin
  • Nicotinamide
  • Dexpanthenol
  • Calcium chloride hexahydrate
  • Magnesium sulfate
  • Potassium chloride
  • GLUCOSE, ANHYDROUS
  • L-arginine hydrochloride
  • L-CYSTEINE HYDROCHLORIDE MONOHYDRATE
  • SODIUM L-GLUTAMATE
  • L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
  • L-ISOLEUCINE
  • L-LEUCINE
  • L-lysine hydrochloride
  • L-METHIONINE
  • PHENYLALANINE DL
  • L-THREONINE
  • DL-Tryptophan
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Product identification

Medicine name:
DUPHALYTE
ДУФАЛАЙТ
Active substance:
  • Thiamine hydrochloride
  • RIBOFLAVIN SODIUM PHOSPHATE
  • Pyridoxine hydrochloride
  • Cyanocobalamin
  • Nicotinamide
  • Dexpanthenol
  • Calcium chloride hexahydrate
  • Magnesium sulfate
  • Potassium chloride
  • GLUCOSE, ANHYDROUS
  • L-arginine hydrochloride
  • L-CYSTEINE HYDROCHLORIDE MONOHYDRATE
  • SODIUM L-GLUTAMATE
  • L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
  • L-ISOLEUCINE
  • L-LEUCINE
  • L-lysine hydrochloride
  • L-METHIONINE
  • PHENYLALANINE DL
  • L-THREONINE
  • DL-Tryptophan
Target species:
  • Horse
  • Cattle
  • Pig
  • Dog
  • Cat
  • Chicken
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Thiamine hydrochloride
    0.10
    milligram(s)
    /
    1.00
    millilitre(s)
  • RIBOFLAVIN SODIUM PHOSPHATE
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • Pyridoxine hydrochloride
    0.10
    milligram(s)
    /
    1.00
    millilitre(s)
  • Cyanocobalamin
    0.05
    microgram(s)
    /
    1.00
    millilitre(s)
  • Nicotinamide
    1.50
    milligram(s)
    /
    1.00
    millilitre(s)
  • Dexpanthenol
    0.05
    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)
  • Potassium chloride
    0.20
    milligram(s)
    /
    1.00
    millilitre(s)
  • GLUCOSE, ANHYDROUS
    45.46
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-arginine hydrochloride
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-CYSTEINE HYDROCHLORIDE MONOHYDRATE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • SODIUM L-GLUTAMATE
    0.04
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
    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)
  • L-lysine hydrochloride
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-METHIONINE
    0.01
    milligram(s)
    /
    1.00
    millilitre(s)
  • PHENYLALANINE DL
    0.03
    milligram(s)
    /
    1.00
    millilitre(s)
  • L-THREONINE
    0.02
    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
    • Cattle
    • Pig
    • Dog
    • Cat
  • Subcutaneous use
    • Cattle
    • Pig
    • Cat
    • Dog
    • Chicken
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA11A
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of 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:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2050-12.06.2013
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Bulgarian (PDF)
Published on: 25/08/2022
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