CIPROFLOXACIN ALPHAPHARM ciprofloxacin 200mg/100mL injection for intravenous infusion

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciprofloxacin

Available from:

Alphapharm Pty Ltd

INN (International Name):

Ciprofloxacin

Authorization status:

Registered

Patient Information leaflet

CIPROFLOXACIN
ALPHAPHARM
_ciprofloxacin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CIPROFLOXACIN
ALPHAPHARM. It does not contain
all the available information. It does
not take the place of talking to your
doctor or your pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
CIPROFLOXACIN
ALPHAPHARM 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
CIPROFLOXACIN
ALPHAPHARM IS
USED FOR
CIPROFLOXACIN
ALPHAPHARM is used to treat
serious infections in the lungs, skin,
blood, bone and joints, kidneys and
bowel.
CIPROFLOXACIN
ALPHAPHARM is also used to treat
inhalational anthrax (an infection
caused by breathing in the spores of
bacteria).
CIPROFLOXACIN
ALPHAPHARM contains the drug
ciprofloxacin, which is an antibiotic
belonging to a group of medicines
called quinolones (pronounced kwin-
o-lones). These antibiotics work by
killing the bacteria which cause
infections in the body.
CIPROFLOXACIN
ALPHAPHARM is used in
hospitalised patients where the use of
ciprofloxacin tablets is inappropriate.
CIPROFLOXACIN
ALPHAPHARM 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 ARE GIVEN
CIPROFLOXACIN
ALPHAPHARM
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
CIPROFLOXACIN
ALPHAPHARM IF YOU HAVE AN
ALLERGY TO:
•
ciprofloxacin
•
other quinolone antibiotics
including nalidixic acid,
moxifloxacin, norfloxacin
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CIPROFLOXACIN ALPHAPHARM
_ciprofloxacin intravenous infusion injection _
1
NAME OF THE MEDICINE
Ciprofloxacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIPROFLOXACIN ALPHAPHARM is available as a ciprofloxacin (as lactate)
200 mg/100 mL and 400
mg/200 mL infusion solution.
Each intravenous infusion injection bag contains 200 mg in 100 mL or
400 mg in 200 mL of ciprofloxacin as
the active ingredient.
Excipient with known effect: glucose
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
The solution is a clear, colourless to a slightly yellowish solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CIPROFLOXACIN ALPHAPHARM is indicated for use in the following:
•
Use in hospitalised adult patients in whom oral ciprofloxacin is
indicated but cannot be administered
or where the oral form is inappropriate
•
Treatment of serious or life-threatening infections due to sensitive
organisms involving the following
organ systems: lower respiratory tract infections (Gram negative
organisms); skin and skin structure;
septicaemia; bone and joint; urinary tract
•
Inhalational anthrax (post-exposure). To reduce the incidence or
progression of disease following
exposure to aerosolised
_Bacillus anthracis_
. Ciprofloxacin serum concentrations achieved in humans
serve as a surrogate endpoint reasonably likely to predict clinical
benefit and provide the basis for this
indication
Note: because Gram-positive organisms are generally less sensitive to
ciprofloxacin, it may not be the drug of
choice in cases with Gram-positive infections due to
_Strep pneumoniae_
.
If anaerobic organisms are suspected of contributing to the infection,
use of other suitable drugs should be
considered.
Strains of
_N gonorrhoeae_
resistant to ciprofloxacin have been reported in Australia.
Appropriate culture and susceptibility tests should be performed
before treatment in order to isolate and
identify organisms causing infection and to determine their
susceptibility to cipro