MILOXY Granules for Oral Suspension 125MG5ML

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
29-01-2019
Ciri produk Ciri produk (SPC)
29-01-2019

Bahan aktif:

AMOXYCILLIN TRIHYDRATE

Boleh didapati daripada:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

AMOXYCILLIN TRIHYDRATE

Unit dalam pakej:

1 BOTTLE

Dikeluarkan oleh:

Milan Laboratories Private Limited

Risalah maklumat

                                MILOXY GRANULES FOR ORAL SUSPENSION 125MG/5ML
Amoxicillin (125mg/5ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Miloxy is used for
2.
How Miloxy works
3.
Before you use Miloxy
4.
How to use Miloxy
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Miloxy
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MILOXY IS USED FOR
Miloxy is used to treat infections caused
by
certain
bacteria
and
other
microorganisms which include:
•
Infections of the ear, throat and nose
•
Infections
of
the
lower
respiratory
tract (bronchitis and pneumonia, lung
disease, whooping cough)
•
Kidney
infection,
inflammation
of
prostate, bladder, urethra, gonorrhoea.
•
Gynaecological
infection
(septic
abortion, adnexitis, endometritis)
•
Gastrointestinal
infections
(typhoid
fever, paratyphoid, shigellosis cause
infection,
infection
of
the
biliary
system (cholangitis, cholecystitis)
•
Skin and soft tissue infections
•
Prevention of infections during mouth
or throat surgery.
HOW MILOXY WORKS
Miloxy is a group of medicines called
penicillin. Penicillin is an antibiotic and
works
by
killing
bacteria
that
causes
infection.
BEFORE YOU USE MILOXY
-
_When you must not use it_
_ _
•
If you are allergy to penicillin-type
antibiotics and any of the ingredients
contained in this medicine.
•
If you have ever developed allergy
symptoms
when
taking
other
antibiotics (eg: cephalosporins).
_ _
_Pregnancy and lactation _
Miloxy
may
be
suitable
if
you
are
pregnant, however please consult your
doctor first before starting this antibiotic
therapy.
-
_Before you start use it _
You should check with your doctor:
•
If have hypersensitivity to penicillin
and
beta-lactam
antibiotics.
E.g.:
cephalosporin.
•
If you have kidney disease
•
If you are premature children or in
neonate period.
•
If you have use this antibiotics for a
prolonged period.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any
                                
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Ciri produk

                                MILOXY GRANULES FOR ORAL SUSPENSION 125MG/5ML
AMOXICILLIN 125MG/5ML
NOT TO BE USED IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO PENICILLIN
PRODUCT DESCRIPTION
_MILOXY Granules for Oral Suspension 125mg/5ml: _
Light pink coloured powder with pleasant flavour. After
reconstitution: Pink coloured oral suspension
having pleasant flavour.
COMPOSITION
_MILOXY Granules for Oral Suspension 125mg/5ml: _
Each 5ml contains Amoxicillin Trihydrate BP equivalent to Amoxicillin
125 mg.
PHARMACODYNAMICS
Amoxicillin is a beta-lactam antibiotic that inhibits synthesis of the
bacterial cell wall. It is a broad-
spectrum penicillin and active against both gram-positive and
gram-negative microorganisms.
Clinically relevant gram-negative pathogens covered by amoxicillin are
_Escherichia coli, Proteus _
_mirabilis, Salmonella, Shigella, Haemophilus influenzae, Helicobacter
pylori, Chlamydia _
and others.
Other microorganisms responding to amoxicillin include all those
susceptible to penicillin G, e. g.
Streptococcus groups A, B, C and G, H, L and M,
_Streptococcus pneumoniae,_
non-penicillinase-
producing
_Staphylococcus aureus Neisseri, Erysipelothrix rhusiopathiae,
Corynebacterium, Bacillus _
_anthracis, _
_Actinomycetes, _
_streptobacilli, _
_spirillium _
_minus, _
_Pasteurella _
_multicoda, _
_Listeria _
and
_Spirochetal_
organisms, as well as numerous aerobic organisms (among them
_peptococci, Clostridia _
and
_Fuso_
-bacteria).
PHARMACOKINETIC
Amoxicillin is rapidly absorbed from the gastrointestinal tract. The
absorption of amoxicillin is
unaffected by meals. Following oral administration, peak serum levels
are reached within 1 – 2 hours.
Amoxicillin readily distributes in body tissue and fluids including
purulent and mucoid sputum.
Elimination of amoxicillin is predominantly via renal. Approximately,
60 – 70% of amoxicillin is
excreted unchanged in the urine in 6 hours after administration.
The elimination half-life of amoxicillin is similar for children aged
around 3 months and above. For very
young children (including prete
                                
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