CETRAXAL PLUS EAR DROPS SOLUTION

HYPHENS PHARMA PTE. LTD.

HYPHENS PHARMA PTE. LTD.

Therapeutic

Prescription Only

SOLUTION

**4.2 Posology and method of administration** Posology _Adults and elderly population_ Acute otitis externa and acute otitis media with tympanostomy tubes: Instil 6–8 drops into the affected external ear canal every 12 hours for 7 days. No overall differences in safety and effectiveness have been observed between elderly and other adult patients. _Paediatric population_ The dosage in children aged 6 months and older is the same as for adults for both indications. _Renal/hepatic impairment_ No dosage adjustment is deemed necessary. Method of administration Auricular use. _Precautions to be taken before handling or administering the medicinal product_ The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort 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. For patients with acute otitis media with tympanostomy tubes, the tragus should be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for around 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. To prevent contamination of the dropper tip in order to limit bacterial risks, care should be taken not to touch the auricle or the external ear canal and surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. Keep the bottle until the completion of the treatment.