Altacef 500mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CEFUROXIME AXETIL

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

CEFUROXIME AXETIL

Unit dalam pakej:

5 x 10 Tablets; 5 x 10 Tablets

Dikeluarkan oleh:

Zeiss Pharma Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALTACEF
® FILM COATED TABLET
Cefuroxime Axetil USP (250mg, 500mg)
1
WHAT IS IN THIS LEAFLET
1.
What ALTACEF
®
is used for
2.
How ALTACEF
®
works
3.
Before you use ALTACEF
®
4.
How to use ALTACEF
®
5.
While you are using
6.
Side effects
7.
Storage and Disposal of
ALTACEF
®
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ALTACEF
® IS USED FOR
ALTACEF
®
is used in adults and
children to treat infections of the:

Ears, nose and throat

Lungs or chest

Urinary tract

Skin and soft tissues
ALTACEF
®
is also used to treat:

Sexually transmitted
infections
Your doctor should test the type
of bacteria causing your
infection and monitor whether
the bacteria are sensitive to
ALTACEF
®
during your
treatment
HOW ALTACEF
® WORKS
ALTACEF
®
belongs to a group of
medicines called cephalosporin.
It works by killing bacteria that
cause infections.
BEFORE YOU USE ALTACEF
®
_When you must not use it _
Do not use ALTACEF
®
:

if
you
are
allergic
_(hypersensitive)_
to cefuroxime
or cephalosporin antibiotics or
any of the other ingredients of
ALTACEF
®
.
_ _
ALTACEF
®
is not recommended
for children aged under 3
months, as it has not been
adequately studied in this age
group.
_Before you start use it _
Special care is indicated if you
have experienced an allergic
reaction to penicillin or other
beta-lactam antibiotic
(penicillins, monobactams and
carbapenems).
There is only limited
information about the safety of
ALTACEF
®
in pregnant women.
If you are pregnant your doctor
will discuss with you if the
benefits of taking ALTACEF
®
outweigh the possible risks to
your baby.
The ingredients in ALTACEF
®
can pass into breast milk. If you
are breast-feeding, you must
check with your doctor before you
take ALTACEF
®
.
_Taking other medicines _
Tell your doctor or pharmacist if
you are taking any other
medicines, if you have taken any
recently, or if you start taking new
ones. This includes

Ciri produk

SAME SIZE ARTWORK
LEAFLET SIZE : 264 mm x 186 mm
_For the use only of a Registered Medical Practitioner or _
_a Hospital or a Laboratory _
PE00000 MY
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
COMPOSITION
Each film coated tablet contains:
Cefuroxime axetil USP (amorphous) equivalent to Cefuroxime 250mg
Colour Titanium Dioxide BP
Each film coated tablet contains:
Cefuroxime axetil USP (amorphous) equivalent to Cefuroxime 500mg
Colour Titanium Dioxide BP
PHARMACEUTICAL FORM
Film Coated Tablet
CLINICAL PARTICULARS THERAPEUTIC INDICATIONS
ALTACEF
FILM
COATED
TABLET
is
an
oral
prodrug
of
the
bactericidal
cephalosporin antibiotic cefuroxime, which is resistant to most
β
(beta)-lactamases
and
is
active
against
a
wide
range
of
Gram-positive
and
Gram-negative
organisms.
ALTACEF FILM COATED TABLET are indicated for the treatment of the
infections
caused by susceptible bacteria. Susceptibility to ALTACEF FILM COATED
TABLET will vary with geography and time and local susceptibility data
should be
consulted where available.
INDICATIONS INCLUDE:
l
upper
respiratory
tract
infections
for
example,
ear,
nose
and
throat
infections, such as otitis media, sinusitis, tonsillitis and
pharyngitis
l
lower
respiratory
tract
infections
for
example,
pneumonia,
acute
bronchitis, and acute exacerbations of chronic bronchitis
l
genito-urinary
tract
infections
for
example,
pyelonephritis,
cystitis
and
urethritis
l
skin and soft tissue infections for example, furunculosis, pyoderma
and
impetigo
l
gonorrhoea, acute uncomplicated gonococcal urethritis, and cervicitis
Cefuroxime is also available as the sodium salt for parenteral
administration.
This permits the use of sequential therapy with the same antibiotic,
when a change
from parenteral to oral therapy is clinically indicated.
Where appropriate ALTACEF FILM COATED TABLET is effective when used
following initial parenteral (cefuroxime sodium) in the treatment of
pneumonia and
acute exacerbations of chronic bronchitis.
POSOLOGY AND METHOD OF AD