CIPROFLOXACIN SANDOZ ciprofloxacin (as hydrochloride) 750 mg tablet blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

ciprofloxacin hydrochloride, Quantity: 873 mg (Equivalent: ciprofloxacin, Qty 750 mg)

متاح من:

Sandoz Pty Ltd

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: hypromellose; titanium dioxide; croscarmellose sodium; colloidal anhydrous silica; povidone; sodium starch glycollate type A; stearic acid; macrogol 6000; microcrystalline cellulose; purified talc; magnesium stearate

طريقة التعاطي:

Oral

الوحدات في الحزمة:

14 tablets

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

CIPROFLOXACIN SANDOZ 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. Typhoid and paratyphoid infections and infections due to multiresistant Staph. Aureus are excluded from the above due to insufficient data. Because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the medicine of choice in cases with Gram-positive infections, such as pneumonia due to Strep. Pneumoniae. Chronic bacterial prostatitis should be demonstrated by microbiological evidence localising infection to the prostate. Strains of N. 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 SANDOZ may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. CIPROFLOXACIN SANDOZ 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.

ملخص المنتج:

Visual Identification: White, oblong, biconvex film coated tablets with a breaking notch on both sides and embossed with "cip 750" on the other.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

2002-04-26

نشرة المعلومات

CIPROFLOXACIN SANDOZ
®
1
CIPROFLOXACIN SANDOZ
®
_ciprofloxacin hydrochloride tablets _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Ciprofloxacin
Sandoz.
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 this medicine
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
SANDOZ IS USED
FOR
This medicine is used to treat
infections of the lungs, skin, bones
and joints, kidney and bladder,
prostate and bowel.
Ciprofloxacin Sandoz tablets
contains the active ingredient
ciprofloxacin hydrochloride, which is
an antibiotic belonging to a group of
medicines called quinolone
antibiotics. These antibiotics work by
killing the bacteria that are causing
your infection.
Ciprofloxacin Sandoz 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.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CIPROFLOXACIN
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
ciprofloxacin hydrochloride, the
active ingredient, or to any of the
other ingredients listed at the end
of this leaflet under Product
Description.
•
other medicines belonging to the
quinolone chemical family (e.g.
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 THIS MEDICINE IF YOU
ARE

خصائص المنتج

210810-ciprofloxacin-sandoz-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
CIPROFLOXACIN SANDOZ
® (CIPROFLOXACIN HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Ciprofloxacin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ciprofloxacin Sandoz 250 mg tablet contains ciprofloxacin
hydrochloride equivalent to
250 mg ciprofloxacin.
Each Ciprofloxacin Sandoz 500 mg tablet contains ciprofloxacin
hydrochloride equivalent to
500 mg ciprofloxacin.
Each Ciprofloxacin Sandoz 750 mg tablet contains ciprofloxacin
hydrochloride equivalent to
750 mg ciprofloxacin.
_Not all strengths may be marketed in Australia. _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Ciprofloxacin Sandoz 250 mg tablets are white, round, biconvex
film-coated tablets with a
breaking notch on one side, embossed with ‘cip 250’ on the other.
Ciprofloxacin Sandoz 500 mg tablets are white, oblong, film-coated
tablets with breaking notch
on both sides, embossed with ‘cip 500’ on the other.
Ciprofloxacin Sandoz 750 mg tablets are white, oblong, film-coated
tablets with breaking notch
on both sides, embossed with ‘cip 750’ on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ciprofloxacin Sandoz 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.
NOTE:
•
Typhoid and Paratyphoid infections and infections due to
multi-resistant
_S. aureus_
are
excluded from the above due to insufficient data.
210810-ciprofloxacin-sandoz-pi
Page 2 of 20
•
Because Gram-positive organisms are generally less sensitive to
ciprofloxacin, it may
not be the medicine of choice in cases with Gram-positive infections,
such as
pneumonia due to
_S. pneumoniae. _
•
Chronic bacterial prostatitis should be demonstrated