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 IU/ml injekčný roztok pre kone, hovädzí dobytok, ošípané, ovce, kozy, psy a mačky
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:
  • Slovakia
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:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/025/MR/15-S
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

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 4/02/2022
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Summary of Product Characteristics

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