Veterinary Medicines

UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs

Authorised
  • Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Live
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Product identification

Medicine name:
UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs
UNISTRAIN PRRS Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine
Active substance:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Live
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine reproductive and respiratory syndrome virus, type 1, strain VP-046 BIS, Live
    316228.00
    cell culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AD03
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Intramuscular use: Cardboard box containing 1 vial with 10 doses of freeze-dried powder and 1 vial with 20 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type I glass vial (20ml)
  • Intramuscular use: Cardboard box containing 1 vial with 25 doses of freeze-dried powder and 1 vial with 50 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Type II glass vial (50 ml)
  • Intramuscular use: Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 100 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Type II glass vial (100 ml)
  • Intramuscular use:Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 250 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Type II glass vial (250 ml)
  • Intramuscular use:Cardboard box containing 10 vials with 10 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 25 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 50 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 100 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 125 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 20 ml of solvent. Solvent: Colourless Type I glass vial (20 ml)
  • Intramuscular use:Cardboard box containing 10 vials with 50 ml of solvent. Solvent: Colourless Type II glass vial (50 ml)
  • Intramuscular use:Cardboard box containing 10 vials with 100 ml of solvent. Solvent: Colourless, Type II glass vial (100 ml)
  • Intramuscular use:Cardboard box containing 10 vials with 250 ml of solvent. Solvent: Colourless, Type II glass vial (250 ml)
  • Intradermal use:Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 10 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type I glass vial (10 ml)
  • Intradermal use:Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 20 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type I glass vial (20 ml)
  • Intradermal use:Cardboard box containing 1 vial with 250 doses of freeze-dried powder and 1 vial with 50 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless , Type II glass vial (50 ml)
  • Intradermal use:Cardboard box containing 10 vials with 50 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 100 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 125 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 250 doses of freeze-dried powder. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 50 ml of solvent. Solvent: Colourless Type II glass vial (50 ml)
  • Intradermal use:Cardboard box containing 10 vials with 20 ml of solvent. Solvent: Colourless Type I glass vial (20 ml)
  • Intradermal use:Cardboard box containing 10 vials with 10 ml of solvent. Solvent: Colourless Type I glass vial (10 ml)
  • Intradermal use: Cardboard box containing 10 vials with 25 ml of solvent. Solvent: PET vial (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 200 ml of solvent. Solvent: PET vial (250 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 200 ml of solvent. Solvent: Colourless Type II glass vial (250 ml)
  • Intradermal use: Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 25 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 25 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (50 ml)
  • Intramuscular use: Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 200 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: Colourless Type II glass vial (250 ml)
  • Intradermal use:Cardboard box containing 10 vials with 50 ml of solvent. PET vials (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 20 ml of solvent. PET vials (20 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 10 ml of solvent. PET vials (10 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 1 vial with 250 doses of freeze-dried powder and 1 vial with 50 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 20 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (20 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 10 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (10 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 250 ml of solvent. PET vials (250 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 100 ml of solvent. PET vials (100 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 50 ml of solvent. PET vials (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 10 vials with 20 ml of solvent. PET vials (20 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 250 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (250 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 100 ml of solvent Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (100 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use:Cardboard box containing 1 vial with 25 doses of freeze-dried powder and 1 vial with 50 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use: Cardboard box containing 1 vial with 10 doses of freeze-dried powder and 1 vial with 20 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (20 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use:Cardboard box containing 10 vials with 25 ml of solvent. Solvent: Type II glass vial (50 ml)
  • Intramuscular use: Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 200 ml of solvent. Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap. Solvent: PET vial (250ml) closed with a bromobutyl rubber closure and an aluminium cap.

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:
  • Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Hipra S.A.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-20334
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0287/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

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German (PDF)
Published on: 24/02/2025
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Summary of Product Characteristics

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German (PDF)
Published on: 24/02/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 24/02/2025
Download
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