CIPROBAY HC OTIC SUSPENSION

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

CIPROFLOXACIN HCl EQV CIPROFLOXACIN; HYDROCORTISONE

Διαθέσιμο από:

NOVARTIS (SINGAPORE) PTE LTD

Φαρμακολογική κατηγορία (ATC):

S02AA30

Δοσολογία:

0.20%

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

CIPROFLOXACIN HCl EQV CIPROFLOXACIN 0.2%; HYDROCORTISONE 1%

Οδός χορήγησης:

AURICULAR (OTIC)

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Siegfried El Masnou, S.A

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2000-02-28

Φύλλο οδηγιών χρήσης

6-13-752 CIPROBAY HC 10m#11CBB1 16/7/07 15:17 P gina 1 
6-13-752 CIPROBAY HC 10m#11CBB1 16/7/07 15:17 P gina 2 

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
CIPROBAY
® HC OTIC (CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE OTIC
SUSPENSION)
CIPROBAY
®
HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic
suspension) contains the
synthetic broad spectrum antibacterial agent, ciprofloxacin
hydrochloride, combined with the anti-
Inflammatory corticosteroid, hydrocortisone, in a preserved,
non-sterile suspension for otic use.
Ciprofloxacin, a fluoroquinolone, is available as the
monohydrochloride monohydrate salt of 1-
cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. Its empirical
formula is C
17
H
18
FN
3
0
3
•HCI•H
2
0 and its chemical structure is as follows:
Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17,
21-trihydroxy-(11β)-, is an anti-inflammatory
corticosteroid. Its empirical formula is C
21
H
30
O
5
and its chemical structure is:
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: Ciprofloxacin hydrochloride (2.329mg/ml),
hydrocortisone (micronized) (10mg/ml)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ear drops, suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CIPROBAY HC OTIC is indicated for the treatment of acute otitis
externa in adult and pediatric patients,
one year and older, due to susceptible strains of Pseudomonas
aeruginosa, Staphylococcus aureus, and
Proteus mirabilis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SHAKE WELL IMMEDIATELY BEFORE USING.
For children (age 1 year and older) and adults, 3 drops of the
suspension should be instilled into the
affected ear twice daily for seven days. The suspension should be
warmed by holding the bottle in the
hand for 1-2 minutes to avoid the dizziness which 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.
This position should be maintained for 30-60 seconds to facilitate
penetration of the drops into the ear.
Repeat, if necessary, for the opposite ear. Discard u