StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats

Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary
medicinal product
Dithiothreitol4.00 mgDisodium edetate0.50 mgBenzalkonium chloride0.10 mgDextran 70Sodium dihydrogen phosphate dihydrateDisodium phosphateSodium hydroxide (for pH adjustment)Purified water
Colourless, practically clear solution, practically free of particles.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and cats
3.2 Indications for use for each target species
Supportive treatment of corneal ulcers.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
AN: 03195/2024 & 03197/2024
3.4 Special warnings
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Ocular re-examination should be made at frequent intervals during therapy.
For the correct treatment of corneal ulceration, the underlying cause and/or the
complicating factors should be identified and properly treated.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs and cats:
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Application site reaction
Eye irritation
, Eye inflammation
(blinking, closed eyelid, eye redness,
conjunctival oedema)
1
mild and short, referring to discomfort in the eye occurring after the application of
eye drops
and/or its adnexa
particularly in dogs.
As with any eye drops solution, mild and short discomfort reactions may occur upon
administration.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation.
AN: 03195/2024 & 03197/2024
Pregnancy and lactation:
Laboratory studies in rats and rabbits have not produced any evidence of toxic
effects in the pregnant female.
Use only according to the benefit-risk assessment by the responsible veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
Ocular use.
The veterinary medicinal product is to be administered into the affected eye(s), at a
dose of 2 eye drops, 3 to 4 times daily.
Instructions for opening the container and attachment of dropper applicator:
•
content in the vial.
•
remove the rest of the metal seal (picture 1).
•
•
•
without touching the end intended to be attached to the vial, attach it (picture 3)
to the vial and do not remove it anymore.
•
•
Instructions for use:
Remove the small white screw cap to administer the veterinary medicinal product.
Keep the dogs/cats head steady in a slightly upright position. Hold the container in an
upright position without touching the eye. Rest your hand/little finger on the forehead
of the dog/cat to maintain distance between the container and the eye. Gently pull
the eyelid of the affected eye downwards, this will form a little eyelid pouch. Gently
squeeze the dropper to administer two drops into the eyelid pouch that you created.
AN: 03195/2024 & 03197/2024
Be careful not to touch the dropper tip after opening the container and replace the
white cap after use. Place the container back into the carton in the upright position
and store out of sight and reach of children until the next medication.
Treatment should be continued in accordance with the instructions given by the
individual veterinarian.
When treatment is combined with other ocular products, leave at least 5 to 10
minutes between treatments. If treatment is combined with non-aqueous oily eye
products, administer acetylcysteine eyedrops first.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
None known.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4.