MONOCLOX CAPSULE 250MG

Land: Maleisië

Taal: Engels

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

Werkstoffen:

CLOXACILLIN SODIUM

Beschikbaar vanaf:

KOMEDIC SDN BHD

INN (Algemene Internationale Benaming):

CLOXACILLIN SODIUM

Eenheden in pakket:

1000 Capsules

Geproduceerd door:

MEDOCHEMIE LTD (Factory B)

Bijsluiter

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MONOCLOX CAPSULE
Cloxacillin sodium (250mg)
1
WHAT IS IN THIS LEAFLET
1.
What Monoclox is used for
2.
How Monoclox works
3.
Before you use Monoclox
4.
How to use Monoclox
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Monoclox
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MONOCLOX IS USED FOR
Monoclox
capsules
is
used
to
treat
many
different
types
of
bacterial
infections.
Monoclox
capsules
treats
infections of the skin, soft tissue, heart,
lungs,
urinary
tract,
bone,
muscles,
joints and intestines.
HOW MONOCLOX WORKS
Monoclox capsule contains the active
ingredient cloxacillin. Cloxacillin is an
antibiotic in penicillin class.
It acts by
inhibiting bacterial cell-wall formation
and subsequently killing the bacteria.
_ _
BEFORE YOU USE MONOCLOX
_- When you must not use it _
-
Do not take Monoclox if you are
allergic
(hypersensitive)
to
cloxacillin,
to
penicillins,
cephalosporins
or
any
other
ingredients of this medicine (listed
in Product Description)
-
Do not give Monoclox to children
below 6 years old
_ _
_- Before you start to use it _
Monoclox may
cause
severe
allergy
and serious skin reactions. Stop using
Monoclox and seek medical assistance
immediately if you experience any of
the following symptoms:
-
skin
reddening,
blisters,
rash,
fever, sore throat or eye irritation
Tell your doctor or pharmacist:
-
if you have ever had an allergic
reaction
to
another
penicillin,
cephalosporin,
carbapenem,
other
beta-lactam or any other antibiotics.
-
if you suffer from kidney or liver
disorders
-
if
you
develop
severe
watery
or
bloody diarrhoea, even if it occurs
several
weeks
after
you
have
stopped taking this medicine
-
if you have or had history of seizure
or brain infection
_Pregnancy and breast-feeding _
Please
consult
your
doctor
or
pharmacist
if
you
are
pregnant,
planning
for
pregnancy
or
breast-
feeding before using any medicine. If
you are pregnant, please take Monoclox
capsule with caution

Productkenmerken

spccloxcaps4.1-CY
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MONOCLOX 250mg hard gelatin capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250mg of cloxacillin as cloxacillin sodium
monohydrate.
Excipients with known effect: sunset yellow, sodium.
Each capsule contains 0.16 mg sunset yellow and 13.2 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatine Capsule
Οrange/orange printed “Medochemie” hard gelatin capsules for oral
administration
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Monoclox is indicated for the treatment of infections caused by
gram-positive microorganisms including
infections caused by penicillin-resistant staphylococci:-

Skin and soft tissue infections: boils, abscesses, carbuncles,
furunculosis, infected wounds, infected
burns

Infected skin conditions like ulcers, eczema or acne

Respiratory tract infections

Osteomyelitis, enteritis, endocarditis

UTI
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual dose of cloxacillin is the equivalent of 500mg four times
daily by mouth or 250mg in 1.5ml of
water for injection or if necessary 0.5% lignocaine hydrochloride
solution, by intramuscular injection
every 4 to 6 hours. The equivalent of 500mg in 10ml of water for
injections may be given by slow
intravenous injection over 3 to 4 minutes every 4 to 6 hours or by
intravenous infusion.
Cloxacillin has been administered by intra-articular injection,
dissolved if necessary in a 0.5% solution of
lignocaine hydrochloride, and by intraplueral injection in doses of
500mg daily. Using powder for
injection, up to 250mg has been dissolved in 3ml of sterile water and
inhaled by nebuliser four times
daily.
Doses may be doubled in severe infections.
Children up to 2 years of age may be given one-quarter the adult dose
and those aged 2 to 10 years,
one-half the adult dose.
In staphylococcal meningitis systemic treatment has been supplemented
with intrathecal injections of
cl