Viatris Borax & Boric Acid Eye Wash 20 x 5ml Single-Dose Vials

Viatris Borax & Boric Acid Eye Wash is an ophthalmic cleansing solution intended for eye rinsing in cases of conjunctival irritation.

Each single-dose vial contains 5ml of solution and is designed for hygienic, single-use application.

Benefits

• Helps rinse and cleanse irritated eyes

• Intended for conjunctival irritation

• Convenient single-dose vials

• Can be used for both eyes during the same application

• Suitable for contact lens wearers, although lenses should be removed before use

Active Ingredients

Each 1ml of solution contains:

• Borax – 12mg

• Boric Acid – 18mg

Other Ingredients

Sodium Chloride, Distilled Rose Water, Purified Water.

How to Use

For eye washing only.

Use 1 to 3 times daily.

Wash hands thoroughly before use.

Apply by gently squeezing the single-dose vial to create a stream of solution, taking care not to allow the tip of the vial to touch the surface of the eye.

Remove any excess solution with sterile gauze or cotton.

One single-dose vial may be used for both eyes during the same application.

Precautions

• For ophthalmic use only

• Do not swallow

• Do not inject

• Keep out of the sight and reach of children

• Discard the opened single-dose vial immediately after use

• Do not save an opened vial for later use

• If using eye drops at the same time, wait 15 minutes before instilling them

• Contact lenses should preferably be removed before rinsing the eyes

• Use with caution during pregnancy or breastfeeding

• If vision is temporarily affected after use, do not drive or operate machinery until normal vision returns

Do not use if you are allergic to boric acid, borax, or any of the other ingredients.

Brand: Viatris
Product Type: Ophthalmic Eye Wash
Pack Size: 20 Single-Dose Vials
Volume: 5ml per vial
Total Volume: 100ml

PLEASE READ THE FOLLOWING FULL DISCLOSURE BEFORE TAKING OR USING THIS PRODUCT.

ation

Posology

For ophthalmic washing

1 to 3 eye washes per day.

Pediatric population

No data are available.

Method of administration

Local use.

Washing is performed directly using a stream by turning the single-dose container upside down and pressing it gently, taking care not to allow the single-dose container to come into contact with the surface of the eye, and wiping away any 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 to treat both eyes.

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

In the event of concomitant treatment with eye drops, wait 15 minutes before instillation.

4.3. Contraindications

Hypersensitivity to boric acid, borax or any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Do not inject. Do not swallow.

This product does not contain preservatives. This product may be used by patients who wear contact lenses; however, it is advisable to remove them before performing the eye wash. 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.

4.5. Interaction with other medicinal products and other forms of interaction

In the event of concomitant treatment with eye drops containing a different active substance, allow an interval of 15 minutes between instillations.

4.6. Fertility, pregnancy and breastfeeding

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

4.7. Effects on ability to drive and use machines

Temporary visual discomfort may occur after instillation of the ophthalmic solution and may affect the ability to drive or operate machinery.

In this case, it is advisable not to drive or operate machinery until normal vision has returned.

4.8. Undesirable effects

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

Very common (≥1/10); frequent (≥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).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/.

4.9. Overdose

No cases of overdose have been reported.

In the event of irritation, rinse with sterile saline solution.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

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

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Sodium chloride, distilled rose water, purified water.

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

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

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

6.5. Nature and contents of container

5 mL in single-dose container (LDPE). Box of 10.

5 mL in single-dose container (LDPE). Box of 20.

5 mL in single-dose container (LDPE). Box of 30.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

VIATRIS SANTE

1 RUE DE TURIN

69007 LYON

8. MARKETING AUTHORIZATION NUMBER(S)

· 34009 301 906 3 0: 5 mL in single-dose container (LDPE). Box of 10.

· 34009 301 906 4 7: 5 mL in single-dose container (LDPE). Box of 20.

· 34009 301 906 5 4: 5 mL in single-dose container (LDPE). Box of 30.

9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

[to be completed later by the marketing authorization holder]

10. DATE OF REVISION OF THE TEXT

[to be completed later by the marketing authorization holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

CONDITIONS OF PRESCRIPTION AND SUPPLY

Medicinal product not subject to medical prescription.