CETRAXAL PLUS EAR DROPS SOLUTION

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

Ciprofloxacin Hydrochloride Monohydrate 3.49mg eqv Ciprofloxacin; Fluocinolone Acetonide

Disponible des:

HYPHENS PHARMA PTE. LTD.

Codi ATC:

S02CA03

Dosis:

3mg

formulario farmacéutico:

SOLUTION

Composición:

Ciprofloxacin Hydrochloride Monohydrate 3.49mg eqv Ciprofloxacin 3mg; Fluocinolone Acetonide 0.25mg

Vía de administración:

AURICULAR (OTIC)

tipo de receta:

Prescription Only

Fabricat per:

Laboratorios Salvat S.A.

Estat d'Autorització:

ACTIVE

Data d'autorització:

2014-08-29

Informació per a l'usuari

PACKAGE INSERT 

1.  NAME OF THE MEDICINAL PRODUCT 

Cetraxal Plus ear drops solution 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each  ml  of  solution  contains  3  mg  of  ciprofloxacin  (as  hydrochloride  monohydrate)  and  0.25  mg  of 
fluocinolone acetonide. 

Excipients: 
0.6 mg methyl parahydroxybenzoate (E218) per ml. 
0.3 mg propyl parahydroxybenzoate (E216) per ml. 

For a full list of excipients, see section 6.1. 

3.  PHARMACEUTICAL FORM 

Ear drops, solution. 

Transparent, limpid solution 

4.  CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

Cetraxal plus is indicated in adults and
in children aged 12 years
and older for the local treatment of acute 
otitis externa with
an intact tympanic membrane caused by ciprofloxacin susceptible microorganisms (see 
sections 4.2, 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 

Auricular use. 
_ _
_Posology _
_ _
_Adults _
Instil 4-6 drops into the affected external ear canal every 8 hours. The duration of the treatment will be 8 
days. 
_ _
_Paediatric patients _
The dosage in children is the same as for adults. 

_Renal/ hepatic impairment _
No dosage adjustment is deemed necessary. 
_ _
_Elderly patients _
No dosage adjustment is deemed necessary. 
_ _
_Instruction for correct use of the 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  auricl

Fitxa tècnica

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Cetraxal Plus ear drops solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride
monohydrate) and 0.25 mg
of fluocinolone (as acetonide).
Excipients with known effect:
0.6 mg methyl parahydroxybenzoate (E218) per ml.
0.3 mg propyl parahydroxybenzoate (E216) per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, solution.
Transparent, limpid solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetraxal Plus is indicated in adults and in children aged 6 months and
older for the following
infections:
-
Acute otitis externa (AOE)
-
Acute otitis media in patients with tympanostomy tubes (AOMT)
Caused by ciprofloxacin susceptible microorganisms (see sections 4.2,
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
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 b