APO-NORFLOXACIN norfloxacin 400 mg tablet bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

norfloxacin, Quantity: 400 mg

Tersedia dari:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Internasional):

Norfloxacin

Bentuk farmasi:

Tablet, film coated

Komposisi:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Rute administrasi :

Oral

Unit dalam paket:

14 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

The treatment of adults with complicated and uncomplicated urinary tract infections that are caused by susceptible strains of microorganisms. The treatment of adults with gastrointestional infections, in particular shigellosis and traveller's diarrhoea. Note: Specimens for culture and susceptibility testing should be obtained prior to and during treatment if clinical response warrants. Suppression in adults of chronic, recurrent urinary tract infections.

Ringkasan produk:

Visual Identification: WHITE, CONVEX, OVAL SCORED FILM-COATED TABLET WITH "N" &"F" INTERSPERSED WITH A BREAK LINE EMBOSSED ON ONE SIDE AND THE ARROW SYMBOL ON THE OTHER SIDE.; Container Type: Bottle; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2008-11-19

Selebaran informasi

APO-NORFLOXACIN
1
APO-NORFLOXACIN
_contains the active ingredient norfloxacin _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Norfloxacin. It contains the active
ingredient norfloxacin.
Norfloxacin belongs to a group of
antibiotics called quinolones. It
works by killing the bacteria causing
the infection.
Norfloxacin is an antibiotic used to
treat some bacterial infections, such
as:
•
urinary tract infections
•
infections of the stomach or
intestines, such as traveller's
diarrhoea.
Norfloxacin is also used for patients
who get frequent urinary tract
infections. It may help prevent these
infections from coming back.
Urinary tract infections are caused by
the presence of bacteria in the urinary
system. The bacteria often come
from the intestines where they are
necessary for normal function.
In women, the most common
infection involves the bladder and is
called cystitis. In men, the infection
may involve the prostate, which is
called prostatitis. In both men and
women, the bacteria may travel up to
the kidneys and infect them.
The symptoms of a urinary tract
infection may include an urge to
urinate frequently and in small
amounts, and painful burning when
passing urine. Urinary tract
infections should be treated to avoid
the kidneys being infected.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NORFLOXACIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
norfloxacin for another reason.
Thi

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION – APO-NORFLOXACIN
(NORFLOXACIN) TABLETS
1
NAME OF THE MEDICINE
Norfloxacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-NORFLOXACIN tablets contain 400mg of norfloxacin.
Norfloxacin, a fluoroquinolone, is a synthetic antibacterial agent for
oral administration.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-NORFLOXACIN tablets are white, film-coated, convex, oval shaped
scored tablet, embossed
with "N

F" on one side and ">" on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of adults with complicated and uncomplicated urinary tract
infections that are caused by
susceptible strains of microorganisms.
Treatment of adults with gastrointestinal infections, in particular
shigellosis and traveller’s
diarrhoea.
Note: Specimens for culture and susceptibility testing should be
obtained prior to and during
treatment if clinical response warrants.
Consideration should be given to available official guidance on the
appropriate use of antibacterial
agents.
4.2
D
OSE AND METHOD OF ADMINISTRATION
(see also SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTION FOR USE)
APO-NORFLOXACIN tablets are intended for oral administration.
2
Norfloxacin tablets should be taken 1 hour before or 2 hours after a
meal with a glass of water.
Patients receiving norfloxacin should be well hydrated.
Multivitamins, other products containing iron or zinc, antacids
containing magnesium and
aluminium, sucralfate or Videx (didanosine) chewable/buffered tablets
or the paediatric powder for
oral solution, should not be taken within two hours of administration
of norfloxacin (see SECTION 4.4
SPECIAL WARNINGS AND PRECAUTION FOR USE)
URINARY TRACT INFECTION
Normal Renal Function
The recommended dosage of norfloxacin for the treatment of urinary
tract infection is 400 mg twice
daily for 7 to 10 days.
For uncomplicated lower urinary tract infections, the recommended
dosage is 400 mg twice daily for
3 days. In one study of uncomplicated lower urinary trac