Ciproxin HC Otic

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v; Hydrocortisone 10mg equivalent to 1% w/v hydrocortisone;  ;  ; Ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v; Hydrocortisone 10mg equivalent to 1% w/v hydrocortisone

Verfügbar ab:

Novartis New Zealand Ltd

INN (Internationale Bezeichnung):

Ciprofloxacin hydrochloride 2.33 mg (= ciprofloxacin 0.2% w/v)

Darreichungsform:

Ear drops

Zusammensetzung:

Active: Ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v Hydrocortisone 10mg equivalent to 1% w/v hydrocortisone     Excipient: Benzyl alcohol Glacial acetic acid Lecithin Polysorbate 20 Polyvinyl alcohol Purified water Sodium acetate trihydrate Sodium chloride Active: Ciprofloxacin hydrochloride 2.33mg equivalent to ciprofloxacin 0.2% w/v Hydrocortisone 10mg equivalent to 1% w/v hydrocortisone Excipient: Benzyl alcohol Glacial acetic acid Lecithin Polysorbate 20 Polyvinyl alcohol Purified water Sodium acetate trihydrate Sodium chloride

Einheiten im Paket:

Bottle, glass, 10 mL

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Bayer AG

Anwendungsgebiete:

The treatment of acute bacterial external otitis caused by organisms susceptible to the action of ciprofloxacin, including Pseudomonas aeruginosa, Staphylococcus aureus, Acinetobacter anitratus (baumannii), Stenotrophomonas maltophilia, Enterobacteriaceae, Enterococcus faecalis and Proteus mirabilis.

Produktbesonderheiten:

Package - Contents - Shelf Life: Bottle, glass, - 10 mL - 24 months from date of manufacture stored at or below 25°C protect from light. Do not refigerate 14 days opened stored at or below 25°C protect from light. Do not refrigerate

Berechtigungsdatum:

1998-03-20

Gebrauchsinformation

Internal document code
1
cip080720cNZ based on DS cip080720iNZ
CIPROXIN
® HC EAR DROPS
_Ciprofloxacin and Hydrocortisone _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET
CAREFULLY BEFORE YOU USE
CIPROXIN HC EAR DROPS.
This leaflet answers some
common questions about
Ciproxin HC Ear Drops. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet
was last updated on the date
listed on the final page. More
recent information on the
medicine may be available.
You should ensure that you
speak to your pharmacist or
doctor to obtain the most up to
date information on the
medicine.
You can also download the most
up to date leaflet from
www.medsafe.govt.nz.
The updates may contain
important information about the
medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your doctor has
weighed the expected benefits of
you using Ciproxin HC against
the risks this medicine could
have for you.
The information in this leaflet
applies to Ciproxin HC only.
This information does not apply
to similar products, even if they
contain the same ingredients.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE.
WHAT CIPROXIN IS
USED FOR
Ciproxin HC Ear Drops contains
two active ingredients;
ciprofloxacin and
hydrocortisone.
Ciprofloxacin is a
“fluoroquinolone” antibiotic
which kills the bacteria causing
the infection.
Hydrocortisone is a
corticosteroid that reduces the
pain, redness and inflammation.
Ciproxin HC Ear Drops are used
to treat a condition called
bacterial otitis externa, which is
an infection of the outer ear
caused by bacteria which may
cause itching or pain.
Before prescribing Ciproxin HC
Ear Drops for you or your child,
your doctor will have examined
your ear and decided that
Ciproxin HC Ear Drops is the
right medicine.
Your doctor may have
prescribed it for another reason.
Ciproxin HC Ear

Fachinformation

Internal document code
cip080720iNZ
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CIPROXIN
®
HC Ear Drops ciprofloxacin 0.2% and hydrocortisone 1%.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciproxin HC Ear Drops contain 23.3 mg ciprofloxacin hydrochloride
(equivalent to
ciprofloxacin 0.2 % w/v) and hydrocortisone 100 mg (1% w/v).
Excipient with known effect
Benzyl alcohol 9 mg in 1 mL as a preservative.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The treatment of acute bacterial external otitis caused by organisms
susceptible to
the action of ciprofloxacin, including
_Pseudomonas aeruginosa, Staphylococcus _
_aureus, Acinetobacter anitratus (baumannii), Stenotrophomonas
maltophilia,_
_Enterobacteriaceae_
,
_Enterococcus faecalis_
and
_Proteus mirabilis._
4.2.
DOSE AND METHOD OF ADMINISTRATION
For children (aged two years and older) and adults, three drops of the
suspension
should be instilled into the affected ear twice daily for seven days.
The bottle should
be shaken well, immediately before use.
The patient should tilt the head to one side with the affected ear
upward and then the
drops should be instilled. This position should be maintained for a
minimum of 30
seconds to facilitate penetration of the drops into the external ear
canal. Repeat, if
necessary, for the opposite ear.
Patient instructions for use/handling
Remove the closure and put the dropper assembly in place on the
bottle. Ciproxin HC
Ear Drops is a ready to use when dropper assembly is placed on the
bottle.
Shake well immediately before using.
Warm to room temperature prior to application.
Avoid contaminating the dropper with material from the ear, fingers or
other sources.
Discard unused portion after therapy is completed.
Keep all medicines out of the reach of children.
Internal document code
cip080720iNZ
2
4.3.
CONTRAINDICATIONS
Ciproxin HC Ear Drops are contraindicated in patients being treated
for necrotizing
malignant otitis externa. This condition,