NUFLOXIB norfloxacin 400 mg film-coated tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

norfloxacin, Quantity: 400 mg

Предлага се от:

Alphapharm Pty Ltd

INN (Международно Name):

Norfloxacin

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: macrogol 4000; hypromellose; colloidal anhydrous silica; magnesium stearate; propylene glycol; microcrystalline cellulose; lactose monohydrate; purified talc; titanium dioxide; croscarmellose sodium

Начин на приложение:

Oral

Броя в опаковка:

14 tablets, 6 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

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. Suppression, in adults, of chronic, recurrent urinary tract infection.

Каталог на резюме:

Visual Identification: White, oval, biconvex film coated tablets.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Registered

Дата Оторизация:

2008-04-07

Листовка

NUFLOXIB
_norfloxacin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nufloxib. 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 Nufloxib
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 YOUR
MEDICINE.
You may need to read it again.
WHAT NUFLOXIB IS USED
FOR
The name of your medicine is
Nufloxib. It contains the active
ingredient norfloxacin.
Nufloxib is an antibiotic that belongs
to a group of medicines called
quinolones. Nufloxib works by
killing the bacteria that are causing
your infection in different parts of the
body.
Nufloxib is also used to treat;
•
Treat urinary tract infections
•
Treat gastrointestinal infections,
in particular shigellosis and
traveller's diarrhoea.
Nufloxib will not work against
infections caused by viruses, such as
colds or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NUFLOXIB HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Nufloxib for another reason.
Nufloxib is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
NUFLOXIB
_WHEN YOU MUST NOT TAKE_
_NUFLOXIB_
DO NOT TAKE NUFLOXIB IF YOU HAVE
AN ALLERGY TO
•
other products containing
norfloxacin (such as Noroxin,
Norflohexal, nalidixic acid,
Insensye)
•
any other quinolone antibiotic
such as Avelox, C-Flox
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include asthma,
wheezing, shortness of breath,
swelling of the face, lips or tongue,
which may cause difficulty in
swallowing or breathing. Symptoms
may also include skin rash, itching,
hives or joint pain.
DO NOT GIVE NUFLOXIB TO CHILDREN OR
TO GROWING TEENAGERS (UNDER THE
AGE OF 18), UNLESS ADVISED BY THE
DOCTOR.
The safety an

Данни за продукта

AUSTRALIAN PRODUCT INFORMATION
NUFLOXIB
_Norfloxacin film-coated tablet _
1
NAME OF THE MEDICINE
Norfloxacin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Norfloxacin is a white to pale yellow crystalline powder.
Each tablet of Nufloxib contains 400 mg of norfloxacin as the active
ingredient.
Nufloxib also contains lactose monohydrate.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Nufloxib tablets are white, oval, biconvex film coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT
Nufloxib is indicated for treatment of adults with:
•
Complicated and uncomplicated urinary tract infections that are caused
by susceptible strains
of microorganisms.
•
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.
SUPPRESSION
Nufloxib is indicated for the suppression, in adults, of chronic,
recurrent urinary tract infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
Norfloxacin tablets should be taken one hour before or two hours after
a meal with a glass of water.
Patients receiving norfloxacin should be well hydrated. Multivitamins,
calcium preparations, 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
PRECAUTIONS FOR USE).
Nufloxib tablets should not be halved.
URINARY TRACT INFECTION
_NORMAL RENAL FUNCTION _
The recommended dosage of Norfloxacin for the treatment of urinary
tract infection is 400 mg twice
daily for seven to ten days.
NUFLOXIB – PRODUCT INFORMATION
2
For uncomplicated lower urinary tract infections, the recommended
dosage is 400 mg