Veterinary Medicines

Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Authorised
  • Oxytocin
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Product identification

Medicine name:
Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats
Oxytobel 10 NE/ml oldatos injekció lovak, szarvasmarhák, sertések, juhok, kecskék, kutyák és macskák részére
Active substance:
  • Oxytocin
Target species:
  • Cattle
  • Dog
  • Goat
  • Sheep
  • Horse
  • Cat
  • Pig
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Oxytocin
    10.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
  • Intravenous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Cattle
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Goat
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Horse
      • Meat and offal
        0
        day
      • Milk
        0
        hour
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Available in:
  • Hungary
Package description:
  • Type I (10 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 10 ml in a cardboard box
  • Type I (10 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.5 x 10 ml in a cardboard box
  • Type I (10 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.12 x 10 ml in a cardboard box
  • Type I (25 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 25 ml in a cardboard box
  • Type I (25 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.10 x 25 ml in a cardboard box
  • Type II (50 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 50 ml in a cardboard box
  • Type II (50 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.12 x 50 ml in a cardboard box
  • Type II (50 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.6 x (1 x 50 ml) wrapped with clear foil (multipack)
  • Type II (100 ml) brown glass vial closed with bromobutyl rubber stopper and sealed with aluminium cap.1 x 100 ml in a cardboard box
  • Type II (100 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.12 x 100 ml in a cardboard box
  • Type II (100 ml) brown glass vials closed with bromobutyl rubber stopper and sealed with aluminium caps.6 x (1 x 100 ml) wrapped with clear foil (multipack)

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:
  • Bela-Pharm GmbH & Co. KG
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bela-Pharm GmbH & Co. KG
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 3613/X/14 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0313/001
Concerned member states:
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Hungary
  • Iceland
  • Norway
  • Poland
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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