Ciproxin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciprofloxacin 10 g

Available from:

Bayer New Zealand Limited

INN (International Name):

Ciprofloxacin 10 g

Dosage:

100 mg/mL

Pharmaceutical form:

Oral suspension

Composition:

Active: Ciprofloxacin 10 g Excipient: Hypromellose Magnesium stearate Methacrylic acid copolymer Polysorbate 20 Povidone Lecithin Medium-chain triglycerides Purified water Strawberry flavour 52312 AH Strawberry flavour 54267AH Sucrose

Units in package:

Bottle, plastic, PET, active ingred. microcapsule, 15.9 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, PET, active ingred. microcapsule - 15.9 g - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, PET, diluent - 107.6 g - 24 months from date of manufacture stored at or below 25°C protect from light - Combination pack, 1x(active + diluent) - 100 mL - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1970-01-01

Patient Information leaflet

1910 CIPROXIN
®
SUSPENSION CMI
1
CIPROXIN
® SUSPENSION
(CI·PROX·IN)
_ciprofloxacin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Ciproxin suspension. It does not
contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Ciproxin
suspension against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read
it again.
WHAT CIPROXIN IS
USED FOR
Ciproxin suspension is used for
the treatment of infections of the
lungs, skin, blood, bones, joints,
kidneys, ovaries, fallopian tubes,
bladder, genital organs, prostate,
stomach and bowel. Ciproxin is
also used to treat inhalational
anthrax (an infection caused by
breathing in the spores of the
bacteria).
In children, Ciproxin suspension
is used to treat lung infections
caused by cystic fibrosis (a
genetic disorder that affects the
lungs and the digestive system),
inhalational anthrax and serious
bacterial infections of the bladder
and kidneys.
Ciproxin suspension contains the
active ingredient, ciprofloxacin,
which is an antibiotic belonging
to a group of medicines called
quinolones (pronounced kwin-o-
lones). These antibiotics work by
killing the bacteria that are
causing your infection.
Ciproxin will not work against
infections caused by viruses such
as colds or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
BEFORE YOU TAKE
CIPROXIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CIPROXIN IF YOU
HAVE AN ALLERGY TO:
•
ciprofloxacin, the active
ingredient in Ciproxin
•
any of the ingredients listed at
the end of this leaflet
•
other medicines belonging to
the quinolone chemical
family (e.g. moxifloxacin,
norfloxacin, nalidixic acid).
Some of t

Summary of Product characteristics

191001 Ciproxin DS
Page 1 of 31
NEW ZEALAND DATA SHEET
1.
CIPROXIN
®
Ciproxin 250 mg, film-coated tablets*
Ciproxin 500 mg, film-coated tablets*
Ciproxin 750 mg, film-coated tablets*
Ciproxin 50 mg/mL, oral suspension*
Ciproxin 100 mg/mL, oral suspension**
Ciproxin 2 mg/mL, solution for infusion*
*currently unavailable
** currently available
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
FILM-COATED TABLETS
Ciproxin 250 mg:
1 tablet contains 291 mg ciprofloxacin hydrochloride, corresp. to 250
mg ciprofloxacin as
monohydrate
Ciproxin 500 mg:
1 tablet contains 582 mg ciprofloxacin hydrochloride, corresp. to 500
mg ciprofloxacin as
monohydrate
Ciproxin 750 mg:
1 tablet contains 873 mg ciprofloxacin hydrochloride, corresp. to 750
mg ciprofloxacin as
monohydrate
2.2
ORAL SUSPENSION
Ciproxin 50 mg/mL:
1 bottle consists of 7.95 g of microcapsules which contain 5.0 g
ciprofloxacin
1 bottle with 99.2 g suspension diluent to prepare 100 mL of Ciproxin
Suspension 5 %
1 measuring spoonful (approx. 5.0 mL) contains approx. 250 mg
ciprofloxacin
One measuring spoon (5.0 mL suspension) contains approx. 1.4 g of
sucrose
Ciproxin 100 mg/mL:
1 bottle consists of 15.9 g of microcapsules which contain 10.0 g
ciprofloxacin
191001 Ciproxin DS
Page 2 of 31
1 bottle with 91.7 g suspension diluent to prepare 100 mL of Ciproxin
Suspension 10 %
1 measuring spoonful (approx. 5.0 mL) contains approx. 500mg
ciprofloxacin
One measuring spoon (5.0 mL suspension) contains approx. 1.3 g of
sucrose
2.3
SOLUTION FOR INFUSION
Ciproxin 2 mg/mL:
1 glass bottle of 100 mL infusion solution contains 254.4 mg
ciprofloxacin lactate, corresp. to
200 mg ciprofloxacin. Sodium chloride content is 900 mg .
For the full list of excipients, see _section 6.1 List of excipients.
_
3.
PHARMACEUTICAL FORM
3.1
FILM-COATED TABLET
Ciproxin 250 mg:
Round, nearly white to slightly yellowish film-coated scored tablets
marked with “CIP 250” on
one side and a “Bayer cross” on the reverse side. The tablet can
be divided into equal
halves.
Ciproxin 500 mg:
Oblong, nea