Maxitrol
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCE
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE
- 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 OF UNUSED
- 11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
- 12. MARKETING AUTHORISATION NUMBERS
- 13. LOT NUMBER
- 14. GENERAL CATEGORY OF AVAILABILITY
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
- 19. OTHER INFORMATION
INFORMATION DISPLAYED ON OUTER PACKAGING
LABEL FOR THE CARDBOARD BOX
1. NAME OF THE MEDICINAL PRODUCT
Maxitrol, (1 mg + 3500 i.u. + 6000 i.u.)/g, ophthalmic ointment
Dexamethasone + Neomycin sulfate + Polymyxin B sulfate
2. COMPOSITION OF ACTIVE SUBSTANCE
1 g of ointment contains 1 mg of dexamethasone, 3500 i.u. of neomycin sulfate and 6000 i.u. of polymyxin B sulfate.
3. LIST OF EXCIPIENTS
Excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), anhydrous liquid lanolin, white vaseline.
4. PHARMACEUTICAL FORM AND CONTENTS OF THE PACKAGE
Sterile ophthalmic ointment
3.5 g GTIN number: 5909991493998
5. METHOD AND ROUTE OF ADMINISTRATION
Ophthalmic administration.
Read the instruction leaflet before using the medicine.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
8. EXPIRY DATE
Expiry date - EXP
Discard 4 weeks after first opening the tube.
9. STORAGE INSTRUCTIONS
Do not store above 25°C. Do not store in the refrigerator.
Keep the container tightly closed.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVING FROM IT, IF
APPLICABLE
11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
Responsible entity in Belgium, country of export:
Novartis Pharma NV
Medialaan 40, B-1800 Vilvoorde, Belgium
12. MARKETING AUTHORISATION NUMBERS
Marketing authorisation number in Belgium, country of export: BE092145
Parallel import authorisation number: 311/22
13. LOT NUMBER
Lot number - Lot
14. GENERAL CATEGORY OF AVAILABILITY
Rp - Medicinal product subject to medical prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
Maxitrol ointment
17. UNIQUE IDENTIFIER – 2D CODE
Includes a 2D code serving as the carrier of the unique identifier.
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
PC: 05909991493998
SN:
NN:
19. OTHER INFORMATION
Manufacturer:
Siegfried El Masnou, S.A., Camil Fabra 58, 08320 El Masnou, Barcelona, Spain
SA ALCON-COUVREUR NV, Rijksweg 14, B-2870 Puurs, Belgium
Novartis Farmacéutica, S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Approved: 17.09.2025