APO-CIPROFLOXACIN ciprofloxacin 500mg (as hydrochloride) tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

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

可用日期:

Arrotex Pharmaceuticals Pty Ltd

INN（国际名称）:

ciprofloxacin hydrochloride

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: sodium starch glycollate type A; purified talc; maize starch; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400

给药途径:

Oral

每包单位数:

14 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

The 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. 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. Ciprofloxacin 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.

產品總結:

Visual Identification: WHITE TO OFF-WHITE, CAPLET-SHAPED, FILM-COATED TABLET, DEBOSSED WITH '500' ON ONE SIDE, PLAIN ON THE OTHER SIDE.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

授权状态:

Registered

授权日期:

2007-08-07

资料单张

APO-CIPROFLOXACIN
TABLETS
_Contains the active ingredient, ciprofloxacin hydrochloride_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about ciprofloxacin. It does
not contain all 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
last page. Some more recent
information on the medicine may be
available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with the medicine.
You may want to read it again.
WHAT IS THIS MEDICINE
USED FOR
The name of your medicine is APO-
Ciprofloxacin. It contains the active
ingredient, ciprofloxacin.
It is used to treat:
•
urinary tract infections
•
kidney and bladder infections
•
bowel infections
•
lung infections
•
skin infections
•
bone and joint infections
•
prostate infections
•
inhalation of anthrax
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
This medicine works by killing the
bacteria which cause these infections.
It will not work against viral
infections such as colds or flu.
Ciprofloxacin belongs to a group of
antibiotic medicines called
quinolones.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
This

产品特点

1
AUSTRALIAN PRODUCT INFORMATION
APO-CIPROFLOXACIN (CIPROFLOXACIN
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg, 500mg or 750mg of ciprofloxacin.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-CIPROFLOXACIN 250 MG TABLETS:
White to off-white, round, film-coated tablets debossed with “250”
on one side and plain on the
other.
APO-CIPROFLOXACIN 500 MG TABLETS:
White to off-white, caplet shaped, film-coated tablets debossed with
“500” on one side and
plain on the other side.
APO-CIPROFLOXACIN 750 MG TABLETS:
White to off-white, caplet shaped, film-coated tablets debossed with
“750” on one side and
plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ciprofloxacin is indicated for the 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 aerosolized _ 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.
2
Note:
1.
Typhoid and Paratyphoid infections and infections due to
multi-resistant _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 cases 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_ resista