SOFILEX ORAL SUSPENSION

País: Malásia

Língua: inglês

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

Ingredientes ativos:

CEPHALEXIN

Disponível em:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

DCI (Denominação Comum Internacional):

CEPHALEXIN

Unidades em pacote:

60ml mL

Fabricado por:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Folheto informativo - Bula

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
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1
SOFILEX POWDER FOR ORAL SUSPENSION
Cephalexin (125mg/5ml)
WHAT IS IN THIS LEAFLET
1.
What is Sofilex used for
2.
How Sofilex works
3.
Before you use Sofilex
4.
How to use Sofilex
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Sofilex
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SOFILEX IS USED FOR
It is used to treat bacterial infection in ear,
respiratory tract, urinary tract, skin and soft
tissues.
HOW SOFILEX WORKS
Cephalexin
is
the
antibiotic
which
kills
bacteria in human body.
BEFORE YOU USE SOFILEX
_- When you must not use it_
Do not use
_Sofilex_
if you are allergic to
Cephalexin,
cephalosporin
group
of
antibiotics,
penicillin
or
any
other
ingredients in this medicine.
_- Before you start to use it_
Tell
your
doctor
or
pharmacist
before
using
_Sofilex_
if you:
•
are pregnant or plan to pregnant.
•
are
breast-feeding
or
plan
to
start
breast-feeding.
•
have kidney problem
•
_Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy,
supermarket
or health
food
shop.
In particular, tell your doctor if you are
taking any of the following:
-
Other antibiotics
-
Diuretics
(water
tablet)
such
as
Furosemide
-
Probenecid for a treatment of gout
HOW TO USE SOFILEX
_- How much to use_
•
_Children 6-12 years old:_
10ml (250mg) every 8 hours.
•
_Children 1-5 years old:_
5ml (125mg) every 8 hours
•
_Children under 1 year old:_
5ml (125mg) every 12 hours
Follow
all
directions
given to
you
by
your
doctor
and
pharmacist
carefully.
They
may
differ
from
the
information
contained in this leaflet. If you do not
understand the instructions on the label,
ask yo

Características técnicas

Important information. Please read carefully.
Sofilex
FOR ORAL SUSPENSION
Cephalexin Broad Spectrum Antibiotic
COMPOSITION
Each
5ml
when
reconstituted
contains
Cephalexin
125mg.
Sodium
Benzoate 0.01g as preservative.
PHARMACODYNAMICS
Cephalexin
is
a
beta-lactam
antibiotic.
It
is
bactericidal
and
acts
by
inhibiting synthesis of the bacterial cell wall. It has good activity
against a
wide spectrum of Gram-positive bacteria and it is most active against
Gram-positive cocci. It has moderate activity against some
Gram-negative
bacilli. Sensitive Gram-positive cocci include both penicillinase and
non-
penicillinase-producing staphylococci.
PHARMACOKINETICS
Cephalexin is almost completely absorbed from the gastro-intestinal
tract.
If cephalexin is taken with food, absorption may be delayed, but the
total
amount absorbed is not appreciably altered. Up to 15% of a dose is
bound
to plasma proteins. The plasma half-life is about 1 hour; it increases
with
reduced renal function. Cephalexin is widely distributed in the body
but
does not enter the cerebrospinal fluid in significant quantities. It
crosses
the placenta and small quantities are found in the milk of nursing
mothers.
Cephalexin is not metabolised. About 80% or more of a dose is excreted
unchanged in the urine, some may be excreted in the bile.
INDICATIONS
Cephalexin is administered by mouth for the treatment of susceptible
infections including those of the respiratory, urinary tracts and of
the skin.
It is also indicated in upper respiratory infections including
pharyngitis and
tonsillitis (caused by _Streptococcus pyogenes_) and otitis media
(caused by
_Str. pneumoniae_, _H. Influenzae_, _Staphylococci_ and _S.
pyogenes_.)
DOSAGE AND ADMINISTRATION
For oral administration only.
To Reconstitute: Shake to loosen powder.
Add water of at least 30ml and shake vigorously to disperse powder.
Add
water to the 60ml mark and shake well.
Child under 1 year: 5ml every 12 hours
Child 1-5 years: 5ml every 8 hours
Child 6-12 years: 10ml every 8 hours
CONTRAINDICATIONS
Allergy to