Pseudovac
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCES
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 7. OTHER SPECIAL WARNINGS, IF NECESSARY
- 8. EXPIRY DATE
- 9. STORAGE INSTRUCTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER
- 13. BATCH NUMBER
- 14. GENERAL CATEGORY OF AVAILABILITY
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
INFORMATION ON OUTER PACKAGING
5 VIALS IN A CARDBOARD BOX
1. NAME OF THE MEDICINAL PRODUCT
Pseudovac
Polyvalent vaccine against Pseudomonas aeruginosa
2. COMPOSITION OF ACTIVE SUBSTANCES
1 ml of vaccine contains:
Pseudomonas aeruginosa antigens from 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 PACKAGE CONTENTS
Solution for injection
5 vials of 1 ml each Code: 5909990038824
5. METHOD AND ROUTE OF ADMINISTRATION
Read the instruction leaflet before using the medicine.
Intramuscular administration.
Shake before use.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
Do not use after the expiry date.
8. EXPIRY DATE
EXP
Expiry date (EXP)
9. STORAGE INSTRUCTIONS
Store in the refrigerator.
Do not freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL
UNUSED MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Institute of Biotechnology Sera and Vaccines BIOMED Joint Stock Company
Al. Sosnowa 8
30-224 Kraków
Logo IBSS BIOMED S.A.
12. MARKETING AUTHORISATION NUMBER
Authorisation number R/0388
13. BATCH NUMBER
Lot
Batch number (Lot)
14. GENERAL CATEGORY OF AVAILABILITY
Rp-Prescription-only medicine.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE SYSTEM
Justification for the absence of information in Braille system has been accepted.
17. UNIQUE IDENTIFIER – 2D CODE
Includes a 2D code containing the unique identifier.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
PC:
SN:
NN: