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
  • Water for injection
Download as PDF

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
  • Water for injection
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
    3162.27
    cell culture infective dose 50
    /
    1.00
    Dose
  • Water for injection
    1.00
    other
    /
    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:
  • Medicinal product on medical prescription for non-renewable delivery
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) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use: Cardboard box containing 10 vials with 50 ml of solvent. Solvent: Colourless Type II glass vial (50 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use: Cardboard box containing 10 vials with 100 ml of solvent. Solvent: Colourless, Type II glass vial (100 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use: Cardboard box containing 10 vials with 250 ml of solvent. Solvent: Colourless, Type II glass vial (250 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: 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) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use: Cardboard box containing 10 vials with 20 ml of solvent. Solvent: Colourless Type I glass vial (20 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use: Cardboard box containing 10 vials with 10 ml of solvent. Solvent: Colourless Type I glass vial (10 ml) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use: Cardboard box containing 10 vials with 25 ml of solvent. Solvent: PET vial closed with a bromobutyl rubber closure and an aluminium cap.
  • Intramuscular use: Cardboard box containing 10 vials with 200 ml of solvent. Solvent: PET vials (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) closed with a bromobutyl rubber closure and an aluminium cap.
  • Intradermal use: Cardboard box containing 10 vials with 25 ml of solvent. Solvent: Solvent: Colourless Type I glass vial 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.
  • 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.
  • 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 (10 ml) 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
  • Cyprus
  • 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

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/12/2021
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/12/2021
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 17/12/2021
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."