CETRAXAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CIPROFLOXACIN AS HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

Available from:

CTS LTD

ATC code:

S03AA07

Pharmaceutical form:

EAR DROPS

Composition:

CIPROFLOXACIN AS HYDROCHLORIDE 3 MG / 1 ML; FLUOCINOLONE ACETONIDE 0.25 MG / 1 ML

Administration route:

OTIC

Prescription type:

Required

Manufactured by:

LABORATORIOS SALVAT S.A., SPAIN

Therapeutic group:

CIPROFLOXACIN

Therapeutic area:

CIPROFLOXACIN

Therapeutic indications:

Cetraxal 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.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Authorization date:

2019-02-11

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's
prescription only
CETRAXAL
EAR DROPS
ACTIVE INGREDIENTS:
3 mg/ml
Ciprofloxacin (as HCl)
0.25 mg/ml
Fluocinolone Acetonide
For information regarding inactive ingredients and
allergens, see section 2 – “Important information about
some ingredients of the medicine” and section 6 –
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE
MEDICINE. This leaflet contains concise information about
the medicine. If you have any other questions, refer to the
doctor or the pharmacist.
This medicine has been prescribed for treatment of your
illness. Do not pass it on to others. It may harm them even
if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for local treatment of an acute
inflammation of the outer ear (acute otitis externa) and an
inflammation of the middle ear (otitis media) following ear
tube surgery, caused by bacteria.
The medicine is intended for adults and children over 6
months of age.
THERAPEUTIC CLASS:
Ciprofloxacin – a fluoroquinolone antibiotic. Ciprofloxacin
works by killing infection-causing bacteria.
Fluocinolone acetonide – a corticosteroid with anti-
inflammatory and pain-relieving properties for treatment of
swelling and pain.
2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF:
•
You are sensitive to fluocinolone acetonide,
ciprofloxacin, other quinolones, or to any of the
additional ingredients the medicine contains (see
section 6).
•
In case of an ear infection caused by a virus or
fungus. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
•
If during treatment you develop signs of urticaria
(hives), skin rash or other allergy signs (e.g., sudden
swelling of the face, throat or eyelids, trouble
breathing), you must discontinue treatment immediately
and contact your doctor. An immediate emergency
treatment may be required if you suffer from severe
re

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Cetraxal
Ear drops solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains
3 mg
of ciprofloxacin (as hydrochloride) and 0.25 mg of
fluocinolone acetonide.
Excipients with known effect:
0.6 mg methyl parahydroxybenzoate per ml.
0.3 mg propyl parahydroxybenzoate per ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops, solution.
Clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cetraxal 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.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
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.
_ _
_Paediatric population _
The dosage in children aged 6 months and older is the same as for
adults for both
indications.
_ _
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
2
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 r