Page 107 - MEMENTO THERAPEUTIQUE RCP 2024

MONOPROST SDU_FR/H/0499/001/IA/36
T2345 50 µg/ml Eye drops, solution

MODULE 1 - ADMINISTRATIVE INFORMATION AND PRESCRIBING
INFORMATION
1.3 PRODUCT INFORMATION
1.3.1 SPC, Labelling and Package Leaflet

doses (5, 50 and 250 micrograms/kg/day) of latanoprost. However, latanoprost induced
embryolethal effects in rabbits at doses of 5 micrograms/kg/day and above.

The dose of 5 micrograms/kg/day (approximately 100 times the clinical dose) caused
significant embryofoetal toxicity characterised by increased incidence of late resorption and
abortion and by reduced foetal weight.

No teratogenic potential has been detected.

Ocular toxicity
Ocular administration of MONOPROST eye drops to animals twice a day during 28 days did
not demonstrate any local or systemic toxic effect.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Macrogolglycerol hydroxystearate 40

Sorbitol

Carbomer 974P
Macrogol 4000

Disodium edetate

Sodium hydroxide (for pH-adjustment)
Water for injections

6.2 Incompatibilities
Not applicable.

6.3 Shelf life
2 years in the outer packaging.

- After first opening of the sachet, use the single-dose containers within 10 days.

After first opening of the single-dose container: use immediately and discard the single-dose
container after use.

10