CIPROFLOXACIN GH ciprofloxacin 500 mg (as hydrochloride monohydrate) tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

ciprofloxacin, Quantity: 500 mg

Tillgänglig från:

Generic Health Pty Ltd

INN (International namn):

Ciprofloxacin

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: maize starch; microcrystalline cellulose; sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; macrogol 4000; titanium dioxide

Administreringssätt:

Oral

Enheter i paketet:

14 tablets

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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 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. 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 Strepto

Produktsammanfattning:

Visual Identification: White to creamish white, capsule-shaped, film-coated tablets with CPR 500 embossed and a break line on one side and BL embossed on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2006-11-28

Bipacksedel

CONSUMER MEDICINE INFORMATION
CIPROFLOXACIN GH
(CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ciprofloxacin GH.
This leaflet 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
Ciprofloxacin GH 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 GH IS
USED FOR
Ciprofloxacin GH is used for the
treatment of infections of the
lungs, skin, bones, joints,
kidneys, bladder, prostate and
bowel. Ciprofloxacin GH is also
used to treat inhalational anthrax
(an infection caused by
breathing in the spores of
bacteria).
Ciprofloxacin GH contains the
active ingredient ciprofloxacin
(present as hydrochloride
monohydrate) 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.
Ciprofloxacin GH 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
CIPROFLOXACIN GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CIPROFLOXACIN GH
IF YOU HAVE AN ALLERGY TO:
•
CIPROFLOXACIN, THE ACTIVE
INGREDIENT IN CIPROFLOXACIN
GH;
•
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET;
•
OTHER MEDICINES BELONGING
TO THE QUINOLONE CHEMICAL
FAMILY (EG. MOXIFLOXACIN,
NORFLOXACIN, NALIDIXIC ACID).
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 CI

Produktens egenskaper

AUSTRALIAN PRODUCT INFORMATION – CIPROFLOXACIN GH
(CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ciprofloxacin GH 500 mg tablets contains 500 mg ciprofloxacin (as
hydrochloride monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ciprofloxacin GH 500 mg tablets are white to creamish white,
capsule-shaped, film-coated tablets with
“CPR 500” embossed and break line on one side, and “BL”
embossed 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 or 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.
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_ resistant to ciprofloxacin have been
reported in Australia.
Ciprofloxacin GH v5.0
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(ciprofloxacin hydrochloride monohydrate) film-coated tablet
Appropriate
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