Cipflox

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Ciprofloxacin hydrochloride 832.5mg equivalent to ciprofloxacin 750 mg (anhydrous);  

Boleh didapati daripada:

Viatris Limited

INN (Nama Antarabangsa):

Ciprofloxacin hydrochloride 832.5 mg (equivalent to ciprofloxacin 750 mg; anhydrous)

Dos:

750 mg

Borang farmaseutikal:

Film coated tablet

Komposisi:

Active: Ciprofloxacin hydrochloride 832.5mg equivalent to ciprofloxacin 750 mg (anhydrous)   Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Macrogols Magnesium stearate Maize starch Microcrystalline cellulose Opadry white Y-22-7719 Polydextrose Pregelatinised maize starch Purified water Titanium dioxide Triacetin

Unit dalam pakej:

Blister pack, PVC/PVDC/AL foil, 14s, 14 tablets

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Neuland Laboratories Limited

Tanda-tanda terapeutik:

For complicated urinary tract infections or pyelonephritis due to E.coli in paediatric patients aged 1-17 years. The risk-benefit assessment indicates that administration of ciprofloxacin to paediatric patients is appropriate. Treatment should only be initiated after careful benefit/risk evaluation, due to possible adverse events related to joints/surrounding tissues. The use of ciprofloxacin for other indications is not recommended in children.

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/AL foil, 14s - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/AL foil, 28's (4 trays x 7 tablets) - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Tarikh kebenaran:

2000-08-01

Risalah maklumat

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CIPFLOX
_CIPROFLOXACIN FILM COATED TABLETS 250 MG, 500 MG AND 750 MG _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking CIPFLOX.
This leaflet answers some common
questions about CIPFLOX tablets.
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 CIPFLOX
against the benefits it is expected to
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 CIPFLOX IS
USED FOR
CIPFLOX is used to treat infections
of the:

bronchial tubes and lungs,

skin,

bones and joints,

kidneys,

bladder,

genital organs including
prostate,

abdomen

blood.
CIPFLOX is also used to treat
inhalational anthrax (an infection
caused by breathing in the spores
of bacteria).
CIPFLOX tablets contain the active
ingredient ciprofloxacin. It belongs
to a group of antibiotics called
quinolones.
These antibiotics work by killing the
bacteria that are causing your
infection.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
CIPFLOX is available only with a
doctor’s prescription.
There is no evidence that CIPFLOX
is addictive.
BEFORE YOU TAKE
CIPFLOX
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE CIPFLOX IF YOU HAVE
AN ALLERGY TO:

ciprofloxacin or any other
ingredients listed at the end
of this leaflet

any of the other quinolone
antibiotics, including
nalidixic acid, moxifloxacin
and norfloxacin.
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 CIPFLOX IF YOU ARE
TAKING A MEDICINE CALLED
TIZANIDINE, A

Ciri produk

Page 1 of 25
NEW ZEALAND DATA SHEET
CIPFLOX
1. PRODUCT NAME
CIPFLOX 250 mg, 500 mg and 750 mg, film-coated tablets.
CIPFLOX INFUSION, 2 mg/mL, solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg, 500 mg or 750 mg of
ciprofloxacin.
Each 100 mL bag of infusion contains 200 mg of ciprofloxacin and each
200 mL bag of infusion
contains 400 mg of ciprofloxacin.
For the full list of excipients, see section 6.1.
THIS PRODUCT IS NOT ABLE TO DELIVER ALL APPROVED DOSE REGIMENS.
3. PHARMACEUTICAL FORM
CIPFLOX 250 MG TABLETS: White bi-convex round, film-coated tablets
marked “CF”, “250” on either
side of a score line on one side and “G” on the other side. The
score line is not intended for breaking
the tablet.
CIPFLOX 500 MG TABLETS IN BLISTERS: White bi-convex capsule shaped,
film-coated tablets marked
“CF”, “500” on either side of a score line on one side and
“G” on the other side. Scored CIPFLOX
500 mg tablets can be divided into equal doses.
CIPFLOX 500 MG TABLETS IN BOTTLES: White bi-convex capsule shaped,
film-coated tablets debossed
with “G” on one side of the tablet and “CF 500” on the other
side. Unscored CIPFLOX 500 mg tablets
must not be halved.
CIPFLOX 750 MG TABLETS: White bi-convex capsule shaped, film-coated
tablets marked “CF”, “750”
on either side of a score line on one side and “G” on the other
side. The score line is not intended
for breaking the tablet.
CIPFLOX INFUSION, 2 MG/ML INFUSION: Clear, odourless, sterile solution
in a plastic bag. The pH-
value of the solution for infusion ranges from 3.5 to 4.6.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ADULTS
_UNCOMPLICATED AND COMPLICATED INFECTIONS CAUSED BY CIPROFLOXACIN
SENSITIVE PATHOGENS:_
Infections of the lower respiratory tract.
Page 2 of 25
In the treatment of outpatients with pneumonia due to _Pneumococcus,
_ciprofloxacin should not be
used as a medicine of first choice. Ciprofloxacin can be regarded as a
suitable treatment for
pneumonias