Active substance

Acetylcysteine : 25 mg/ml

ATC code

QS01XA08 Acetylcysteine

QS01XA Other ophthalmologicals

QS01X Other ophthalmologicals

QS01 Ophthalmologicals

QS Sensory organs

Species

Dogs and cats

Indications

Supportive treatment of corneal ulcers.

Dose to be administered and administration route

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:

• Wash hands carefully in order to avoid microbiological contamination of the content in the vial.

• Flip open the metal cap and pull it all the way down along the pre-cut lines. Then remove the rest of the metal seal (picture 1).

• Remove the orange colored stopper (picture 2) from the vial.

• Do not touch the opening of the vial after removing the stopper.

• Take the dropper with the small white screw cap on the top out of its sachet, without touching the end intended to be attached to the vial, attach it (picture 3) to the vial and do not remove it anymore.

• The veterinary medicinal product is now ready for use (picture 4).

• Stromease fig. 1 Stromease fig. 2

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.

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.

Adverse reactions

Dogs and cats:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Application site reaction¹

Eye irritation², Eye inflammation² (blinking, closed eyelid, eye redness, conjunctival oedema)³

¹ mild and short, referring to discomfort in the eye occurring after the application of eye drops

² and/or its adnexa

³ 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.

Dispensing

POM-V - Prescription Only Medicine – Veterinarian

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Stromease 25 mg/ml eye drops, solution for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Acetylcysteine 25.00 mg

Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Dithiothreitol	4.00 mg
Disodium edetate	0.50 mg
Benzalkonium chloride	0.10 mg
Dextran 70
Sodium dihydrogen phosphate dihydrate
Disodium phosphate
Sodium 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.

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 reaction¹

Eye irritation², Eye inflammation² (blinking, closed eyelid, eye redness, conjunctival oedema)³

¹ mild and short, referring to discomfort in the eye occurring after the application of eye drops

² and/or its adnexa³ 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.

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