C-FLOX 500 ciprofloxacin 500mg (as hydrochloride) tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

ciprofloxacin hydrochloride, Quantity: 555 mg (Equivalent: ciprofloxacin, Qty 500 mg)

Beszerezhető a:

Alphapharm Pty Ltd

INN (nemzetközi neve):

ciprofloxacin hydrochloride

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

Excipient Ingredients: crospovidone; pregelatinised maize starch; maize starch; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose

Az alkalmazás módja:

Oral

db csomag:

14 tablets

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

C-FLOX is indicated for treatment of infections caused by susceptible organisms in the conditions listed below: Urinary tract infections - gonorrhoeal urethritis and cervicitis - gastroenteritis, - bronchial infections - skin and skin structure infections - bone and joint infections - chronic bacterial prostatitis of mild to moderate severity. 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: 1. Typhoid and paratyphoid infections and infections due to multiresistant Staphylococcus aureus are excluded from the above due to insufficient data. 2. Because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in case with Gram-positive infections, such as pneumonia due to Streptococcus pneumoniae. 3. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Appropriate culture and susceptibility tests should be performed before treatment in order to determine organism susceptibility to ciprofloxacin and after treatment as warranted by the clinical condition. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. C-FLOX is suitable to treat mixed infections caused by susceptible strains of both gram-negative and Gram-positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiological agents, additional therapy should be considered. Consideration should be given to available official guidance on the appropriate use of antibacterial agents.

Termék összefoglaló:

Visual Identification: WHITE, BICONVEX, CAPSULE SHAPED, FILM-COATED TABLETS MARKED 'CF' SCORELINE '500' ON ONE SIDE, 'G' ON THE REVERSE; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2012-04-19

Betegtájékoztató

C-FLOX
_ciprofloxacin (as hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about C-FLOX. It does not
contain all of 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 C-FLOX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT C-FLOX IS USED
FOR
C-FLOX tablets are used to treat
certain infections of the:
•
lungs
•
skin
•
bones and joints
•
kidney and bladder
•
prostate
•
bowel
C-FLOX is also used to treat
inhalational anthrax (an infection
caused by breathing in the spores of
bacteria.)
C-FLOX tablets contain the active
ingredient ciprofloxacin (as
hydrochloride), 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.
C-FLOX does 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 C-
FLOX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE C-FLOX 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
•
rash, itching or hives on the skin
DO NOT TAKE C-FLOX IF YOU ARE
ALSO TAKING A MEDICINE CALLED
TIZANIDINE, A MUSCLE RELAXANT USED
TO TREAT SPASTICITY ASSOCIATED WITH
MULTIPLE SCLEROSIS, INJURY OR
DISEASES OF THE SPINAL CORD.
C-FLOX can int

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION
C-FLOX
_ciprofloxacin (as hydrochloride) film-coated tablets _
1
NAME OF THE MEDICINE
Ciprofloxacin (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
C-FLOX film-coated tablets contain either 250 mg, 500 mg or 750 mg of
ciprofloxacin (as hydrochloride) as
the active ingredient.
Excipients of known effect: Traces of sulfites.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
C-FLOX 250: a white, biconvex, round, film-coated tablet marked
“CF” scoreline “250” on one side and “G”
on the other, each containing 250 mg of ciprofloxacin.
C-FLOX 500: a white, biconvex, capsule shaped, film-coated tablet
marked “CF” scoreline “500” on one side
and “G” on the other, each containing 500 mg of ciprofloxacin.
C-FLOX 750: a white, biconvex, capsule shaped, film-coated tablet
marked “CF” scoreline “750” on one side
and “G” on the other, each containing 750 mg of ciprofloxacin.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
C-FLOX is indicated for the treatment of infections caused by
susceptible organisms in the following
conditions:
•
Urinary tract infections
•
Gonorrhoeal urethritis and cervicitis
•
Gastroenteritis
•
Bronchial infections
•
Skin and skin structure infections
•
Bone and joint infections
•
Chronic bacterial prostatitis of mild to moderate severity
•
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:
1.
Typhoid and Paratyphoid infections and infections due to
multi-resistant
_Staphylococcus aureus_
are
excluded from the above due to insufficient data
C-FLOX – PRODUCT INFORMATION
2
2.
Because Gram-positive organisms are generally less sensitive to
ciprofloxacin, it may not be the drug
of choice in cases with