TOBRABACT Eye drops, solution Ref.[50600] Active ingredients: Tobramycin

Source: Web Search  Revision Year: 2017  Publisher: MEDICOM HEALTHCARE LTD, 235 Hunts Pond Road, Titchfield Common, PO14 4PJ, United Kingdom

4.1. Therapeutic indications

Topical treatment of infections of the external structures of the eye and its appendages, caused by sensitive organisms.

Consideration should be given to official recommendations regarding the appropriate use of antibacterials agents.

4.2. Posology and method of administration

Adults and the elderly

Instil 1 drop 3-8 times a day into the inferior conjunctival fornix of the eye. In more severe cases of infection, instil 1 drop into the eye every hour until improvement is obtained, then reduce the dose gradually.

Paediatric population

TOBRABACT eye drops solution may be used in children aged 1 and older at the same dose as in adults. Currently available data is described in section 5.1. The safety and efficacy of this medicine in children below the age of 1 have not been established, and no data is available.

When using nasolacrimal occlusion or closing the eyelids for 3 minutes the systemic absorption may be reduced. This may result in a decrease in systemic side effects and in an increase in local activity.

Duration of treatment is 5 to 15 days.

Instructions for use:

a. Wash the hands thoroughly.
b. Do not let the tip of the applicator touch the eye or eyelids.
c. Instil TOBRABACT ophthalmic solution into the fornix of the eye, looking upwards and pulling the lower eyelid gently downwards.
d. Let go of the lower eyelid and blink the eyes several times to make sure that the fluid covers the whole eye.
e. Shut the eye and wipe any excess away.
f. Put the closure on the bottle after use.

4.9. Overdose

A topical overdose may be flushed from the eye(s) with lukewarm water.

6.3. Shelf life

30 months. Keep for 15 days once opened.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

5 ml of ophthalmic solution in LDPE bottle fitted with a 15 mm transparent LDPE applicator and a white 15 mm HDPE white stopper.

6.6. Special precautions for disposal and other handling

As the product contains benzalkonium chloride, soft contact lenses should not be worn during treatment.

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