Background pattern
Pseudovac

Pseudovac

About the medicine

How to use Pseudovac

INFORMATION PLACED ON OUTER PACKAGING

5 AMPULES IN A CARDBOARD BOX

1. NAME OF THE MEDICINAL PRODUCT

Pseudovac

Vaccine polyvalent against Pseudomonas aeruginosablue pus rod

2. CONTENT OF ACTIVE SUBSTANCES

1 ml of the vaccine contains:
Antigens of Pseudomonas aeruginosafrom 7 immunotypes (according to Fisher, Devlin, Gnabasik classification):

  • immunotype 1 - 0.125 ml
  • immunotype 2 - 0.125 ml
  • immunotype 3 - 0.125 ml
  • immunotype 4 - 0.125 ml
  • immunotype 5 - 0.125 ml
  • immunotype 6 - 0.125 ml
  • immunotype 7 - 0.125 ml
  • immunotype 3,7 - 0.125 ml

3. LIST OF EXCIPIENTS

None.

4. PHARMACEUTICAL FORM AND CONTENT OF THE PACKAGING

Solution for injection
5 ampoules of 1 ml Code: 5909990038824

5. METHOD AND ROUTE OF ADMINISTRATION

Read the leaflet contents before using the medicinal product.
Intramuscular administration.
Shake before use.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicinal product in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Do not administer after the expiry date.

8. EXPIRY DATE

EXP
Expiry date (EXP)

9. STORAGE CONDITIONS

Store in a refrigerator.
Do not freeze.

10. SPECIAL PRECAUTIONS FOR DISPOSAL

OF UNUSED MEDICINAL PRODUCT OR WASTE ARISING FROM IT,

IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Institute of Biotechnology of Serum and Vaccines BIOMED Joint Stock Company
Aleja Sosnowa 8
30-224 Kraków
Logo IBSS BIOMED S.A.

12. MARKETING AUTHORISATION NUMBER

Authorisation No R/0388

13. BATCH NUMBER

Lot
Batch number (Lot)

14. GENERAL CATEGORY OF AVAILABILITY

Rp-Medical product available on prescription.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

Justification for the lack of information in the Braille system has been accepted

17. UNIQUE IDENTIFIER - 2D CODE

Includes a 2D code being a carrier of a unique identifier.

18. UNIQUE IDENTIFIER - HUMAN-READABLE DATA

PC:
SN:
NN:

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Importer
    Instytut Biotechnologii Surowic i Szczepionek BIOMED S.A.

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