CETRAXAL Ear drops Ref.[6737] Active ingredients: Ciprofloxacin

Adults and children aged one year and older

Instil the contents of one single ampoule into the affected ear twice daily for seven days.

Paediatric patients less than one year

The safety and efficacy of Cetraxal in children aged below 1 year of age have not been established. No data are available. See section 4.4.

Method of administration

Precautions to be taken before handling or administering the medicinal product

• The solution should be warmed, by holding the ampoule in the hand for several minutes, to avoid the dizziness that may result from the instillation of a cold solution into the ear canal.
• The patient should lie with the affected ear upward and then the drops should be instilled, pulling several times on the auricle. This position should be maintained for around 5 minutes to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
• The patient should be advised to discard the single-dose container after the use, and not keep it for subsequent use.
• In case an otowick/tampon is used to facilitate administration, the first dose should be doubled (2 ampoules instead of 1).

Renal/hepatic impairment

Since the drug plasma concentration is anticipated to be undetectable, no dosage adjustment for these patient groups is deemed necessary.

The potential risk of overdose with this single-dose preparation is negligible since the total amount of ciprofloxacin per pack is 7.5 mg.

2 years.

The ampoule contents should be used immediately after opening the single dose ampoule. Any unused contents should be discarded.

Shelf-life after first opening of the pouch: 8 days.

Store below 30°C. Store in the original packaging in order to protect from light.

The solution 0.2% is contained within a formed low-density polyethylene (LDPE) ampoule. Each single ampoule delivers 0.25 ml dropwise. The ampoules are contained in an aluminium foil overwrap pouch for protection.

Each pack contains 15 ampoules.

Any unused product or waste material should be disposed of in accordance with local requirements.