Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Ciprofloxacin Hydrochloride 2.33mg eqv Ciprofloxacin
HYPHENS PHARMA PTE. LTD.
S02AA15
2mg
SOLUTION
Ciprofloxacin Hydrochloride 2.33mg eqv Ciprofloxacin 2mg
AURICULAR (OTIC)
Prescription Only
Laboratorios Salvat S.A.
ACTIVE
2014-08-29
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Cetraxal 2 mg/ml ear drops solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ML SOLUTION CONTAINS 2 MG OF CIPROFLOXACIN AS HYDROCHLORIDE Each single-dose ampoule delivers 0.25 ml of solution that contains 0.58 mg of ciprofloxacin hydrochloride monohydrate corresponding to 0.50 mg of ciprofloxacin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops solution. Clear, sterile, preservative-free aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa caused by ciprofloxacin susceptible microorganisms (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _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. Instructions for correct use of the 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 necessa Baca dokumen lengkap
PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Cetraxal 2 mg/ml ear drops solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ML SOLUTION CONTAINS 2 MG OF CIPROFLOXACIN AS HYDROCHLORIDE Each single-dose ampoule delivers 0.25 ml of solution that contains 0.58 mg of ciprofloxacin hydrochloride monohydrate corresponding to 0.50 mg of ciprofloxacin. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops solution. Clear, sterile, preservative-free aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetraxal 2 mg/ml ear drops solution is indicated for the treatment of acute otitis externa caused by ciprofloxacin susceptible microorganisms (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _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. Instructions for correct use of the 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 Baca dokumen lengkap