BORAX/BORIC ACID VIATRIS 12 mg/18 mg/ml Solution for ophthalmic rinsing in single-dose container 20Single-dose/5ml

Ophthalmic irrigation solution.

Borax...............................................................................................................................................................12 mg

Boric acid ................................................................................................................................................18 mg

For 1 mL of solution.

Excipients:

Eye irrigation in case of conjunctival irritation.

Dosage

For eye irrigation

1 to 3 eye irrigations per day.

Paediatric population

No data are available.

Method of administration

Topical use.

Irrigation is performed directly by jet, by turning the single-dose container upside down and gently pressing on it, taking care not to bring the single-dose container into contact with the surface of the eye, and wiping off the excess with a compress or absorbent cotton.

Use the single-dose container immediately after opening and discard it after use.

The single-dose container may be used for treating both eyes.

Do not reuse an opened single-dose container.

In case of concomitant treatment with eye drops, it is advisable to wait 15 minutes before instilling them.

Hypersensitivity to boric acid, borax or to any of the excipients listed in section Composition.

Do not inject, do not swallow.

This product does not contain a preservative. This product may be used in patients wearing contact lenses; however, it is advised to remove them before performing eye irrigation. Due to the risk of rapid bacterial contamination, an opened single-dose container must never be reused for subsequent administrations.

Discard the single-dose container immediately after use.

In case of concomitant treatment with an eye drop containing a different active ingredient, separate the instillations by 15 minutes.

Use with caution in pregnant or breastfeeding women, due to a lack of usable clinical data.

A transient visual disturbance may occur after instillation of the solution eye drops and may affect the ability to drive vehicles or use machines.

In this case, it is advised not to drive or use machines until normal vision returns.

The adverse effects identified during clinical trials and after marketing with the association of borax/boric acid are listed by organ system in order of frequency in the table below according to the following convention:

Very common (≥1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from the available data).

System organ class	Frequency	Adverse reaction
Eye disorders	Rare	Eye irritation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported.

In case of irritation, rinse with sterile physiological saline.

Pharmacotherapeutic class: LOCAL ANTISEPTIC/MILD ASTRINGENT FOR OPHTHALMIC USE. ATC code: (S: sensory organs).

3 years.

This medicine does not require any particular storage precautions.

After use, the single-dose container must be discarded.

Do not reuse a single-dose container that has already been opened.

No special requirements.

Marketing authorisation (AMM)

CIP 3400930190630 (10Unit/5ml). CIP 3400930190647 (20Unit/5ml).

Price:

1,87 euros (20 Unit/5 ml).

Social Security reimbursement at 30% (20Unit/5ml) in the indications:

• Indication(s) appearing in the marketing authorization at the publication date of this order (20Unit/5ml)

Not reimbursed by Social Security (10Unit/5ml).
Collection (20Unit/5ml).