Page 154 - MEMENTO THERAPEUTIQUE RCP 2024

FR/H/0411/001/II/020 - Approved SPC

5.3 Preclinical safety data

Preclinical data reveal no special hazard which is considered relevant in connection with
use of ketotifen eye drops in humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to
reproduction.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol
Sodium hydroxide (for pH adjustment)
Water for injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.
After opening: 3 months

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.
For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

5 ml (at least 150 preservative free drops) in multidose bottle (PE) with a dropper
applicator (PE) equipped with a 0.2 microns filtering membrane (polyethersulphone) to
protect the solution against microbial contamination and a media (LDPE) allowing to
control the flow of eye drops onto the membrane.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

<[To be completed nationally]>

8. MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>