CETRAXAL EAR DROPS SOLUTION 2MGML

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Ciprofloxacin Hydrochloride 2.33mg eqv Ciprofloxacin

Предлага се от:

HYPHENS PHARMA PTE. LTD.

АТС код:

S02AA15

дозиране:

2mg

Лекарствена форма:

SOLUTION

Композиция:

Ciprofloxacin Hydrochloride 2.33mg eqv Ciprofloxacin 2mg

Начин на приложение:

AURICULAR (OTIC)

Вид предписание :

Prescription Only

Произведено от:

Laboratorios Salvat S.A.

Статус Оторизация:

ACTIVE

Дата Оторизация:

2014-08-29

Листовка

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

Данни за продукта

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