CEPHEX cefalexin (as monohydrate) 500mg capsule blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

cefalexin monohydrate

Dostupné s:

Amneal Pharma Australia Pty Ltd

INN (Mezinárodní Name):

cefalexin monohydrate

Stav Autorizace:

Registered

Informace pro uživatele

_Cephalexin AN – Consumer Medicine Information _
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_Doc ID: 48.AN.M.1.0 _
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_Page 1 _
CEPHELAXIN AN CAPSULES
_Cephalexin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to
provide you with answers to
some common questions about
this medicine. It does not contain
all the available information.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Cephalexin AN against the
benefits the medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE. You may need to
read it again.
WHAT CEPHALEXIN AN
IS USED FOR
Cephalexin AN contains
cephalexin. Cephalexin is an
antibiotic used to treat infections
in different parts of the body
caused by bacteria. Cephalexin
AN can be used to treat
infections of the:
• Respiratory tract (throat, tonsils,
chest and lungs)
• Nose (sinusitis)
• Ears (otitis media)
• Skin
• Kidneys and bladder
(genitourinary tract)
Cephalexin AN belongs to a
group of antibiotic medicines
called cephalosporins. These
antibiotics work by killing the
bacteria that are causing your
infection.
Your doctor may have
prescribed Cephalexin AN for
another reason. Ask your doctor
if you have any questions about
why Cephalexin AN has been
prescribed for you.
Cephalexin AN is available only
with a doctor’s prescription.
BEFORE TAKING
CEPHALEXIN AN
_WHEN YOU MUST NOT TAKE _
_CEPHALEXIN AN _
Do not take Cephalexin AN if:
• You have had an allergic
reaction to CILEX, any other
medicine containing cephalexin,
or other cephalosporins or any of
the ingredients listed at the end
of this leaflet. Signs of an allergic
reaction may include itching of
the skin, shortness of breath and
swelling of the tongue or face.
• You have had a serious allergic
reaction (Anaphylaxis) to
penicillin, penicillin derivatives,
penicillamine or any other
medicines.
• The packaging is torn or shows
signs of tampering.
• The expiry date on the pack has
passed

Charakteristika produktu

_Cephalexin AN capsules Product Information _
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_ _
_ Amneal Pharma Australia Pty Ltd _
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Cephalexin AN PI v2.0
Page 1
CEPHALEXIN AN
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_(CEPHALEXIN MONOHYDRATE CAPSULES) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is cephalexin monohydrate
CHEMICAL NAME: (6R, 7R)-7-[(R)-2-amino-2-phenyl
acetamido]-3-methyl-8-oxo-5-
thia-1-azabicyclo[4,2.0]oct-2-ene-2-carboxylic acid, monohydrate
MOLECULAR FORMULA: C
16
H
17
N
3
O
4
S, H
2
O
MOLECULAR WEIGHT: 365.4 (as the monohydrate)
CAS REGISTRY NUMBER: _[ 23325-78-2] _
DESCRIPTION
CEPHALEXIN-AN capsules contain cephalexin monohydrate equivalent to
250 mg anhydrous
cephalexin and 500 mg anhydrous cephalexin. The inactive ingredients
are: microcrystalline
cellulose and magnesium stearate. The capsule shells contain gelatin,
sodium lauryl sulphate,
Patent Blue V, Quinoline Yellow, titanium dioxide, Sunset Yellow FCF
and black printing ink
(SW-9008), purified water.
CEPHALEXIN-AN capsules do not contain gluten.
CEPHALEXIN-AN
capsules
contain
cephalexin
which
is
a
semisynthetic
cephalosporin
antibiotic.
PHARMACOLOGY
MICROBIOLOGY
_In vitro _tests demonstrate that the cephalosporins are bactericidal
because they inhibit cell wall
synthesis. Cephalexin is active against the following organisms _in
vitro: _β-haemolytic
streptococci, Staphylococci (including coagulase-positive,
coagulase-negative, and penicillinase
producing strains), _Streptococcus (Diplococcus) pneumoniae,
Escherichia coli, Proteus mirabilis _
and Klebsiella sp.
_Cephalexin AN capsules Product Information _
_ _
_ _
_ Amneal Pharma Australia Pty Ltd _
_ _
_ _
Cephalexin AN PI v2.0
Page 2
_Note: _Most strains of enterococci _(Enterococcus faecalis) _and a
few strains of staphylococci are
resistant
to
cephalexin. Cephalexin
is
not
active
against
most
strains
of
Enterobacter
sp.,
_Morganella morganii _ (formerly _ Pr. Morganii)_, and _ Pr.
Vulgaris_. It has no activity against
Pseudomonas or _Acinetobacter calcoaceticus _(formerly Mima and
Herellea sp). When tested by
_in vitro _meth