AMILOXYN amoxicillin (as trihydrate) 500 mg capsules blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

amoxicillin trihydrate, Quantity: 573.394 mg (Equivalent: amoxicillin, Qty 500 mg)

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

INN (International namn):

amoxicillin trihydrate

Läkemedelsform:

Capsule, hard

Sammansättning:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate; patent blue V; carmoisine

Administreringssätt:

Oral

Enheter i paketet:

20

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms:,Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxycillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.,Skin and Skin Structure: Staphylococcus, non-penicillinase producing; Streptococcus; E.coli. (see Microbiology),Respiratory (Acute and Chronic): H.influenzae, Streptococcus; S.pneumoniae; staphylococcus, non-penicillinase-producing; E.coli. (see Microbiology),Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): E.coli (see Microbioology), P.mirabilis and S.faecalis.,Gonorrhoea: N.gonorrhoeae (non-penicillinase producing).,Prophylaxis of endocarditis: amoxycillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

Produktsammanfattning:

Visual Identification: Maroon/yellow, size"0EL" hard gelatin capsule filled with white to off white granular powder & imprinted with "A" on cap & "86" on body with black ink; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2012-03-01

Bipacksedel

_ Consumer Medicine Information _
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_Page 1 _
AMILOXYN CAPSULES
_amoxicillin (as trihydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you take AMILOXYN.
This leaflet answers some
common questions about
AMILOXYN. It does not contain
all of the available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Sometimes new risks
are found even when a medicine
has been used for many years.
Your doctor has weighed the
expected benefits of you taking
Amoxycillin AN against the risks
this medicine could have for you.
Take AMILOXYN as instructed.
If you have any concerns about
taking this medicine ask your
doctor or pharmacist.
Keep this leaflet with the
medicine.
You may need to read it again.
WHAT AMILOXYN IS
USED FOR
AMILOXYN contains a penicillin
called amoxycillin as the active
ingredient.
AMILOXYN belongs to a group
of medicines called penicillins
AMILOXYN is used to treat a
range of infections caused by
bacteria. These may be
infections of the chest
(pneumonia), tonsils (tonsillitis),
sinuses (sinusitis), urinary and
genital tract, skin and fleshy
tissues.
AMILOXYN works by killing the
bacteria that cause these
infections. AMILOXYN can also
be used to prevent infection.
Your doctor may have
prescribed AMILOXYN for
another reason.
There is no evidence that
AMILOXYN is addictive.
BEFORE YOU TAKE
AMILOXYN
_WHEN YOU MUST NOT BE _
_TAKE IT _
• You are allergic to penicillin or
similar types of antibiotics such
as cephalosporins. If you have
ever had an allergic reaction
(such as a rash) when taking
an antibiotic you should tell
your doctor before you take
AMILOXYN.
• You have ever had an allergic
reaction to amoxycillin or any
of the ingredients listed toward
the end of this leaflet. (See
"Ingredients")
• the expiry date printed on the
pack has passed.
• the packaging is torn or shows
signs of tampering.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF:
• You are allergic t

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION – AMILOXYN (AMOXICILLIN (AS
TRIHYDRATE)) CAPSULES
1
NAME OF THE MEDICINE
Amoxicillin trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMILOXYN is available as capsules containing 250 mg & 500 mg
amoxicillin as trihydrate.
Amoxicillin is a white or almost white, crystalline powder.
EXCIPIENTS WITH KNOWN EFFECT
May contain traces of sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_AMILOXYN 250 MG _
Maroon/yellow size ‘1’ hard gelatin capsule filled with white to
off-white granular powder and imprinted with
‘A’ on maroon cap and ‘85’ on yellow body with black ink.
_AMILOXYN 500MG _
Maroon/yellow size ‘0EL’ hard gelatin capsule filled with white to
off-white granular powder and imprinted
with ‘A’ on maroon cap and ‘86’ on yellow body with black ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
It is indicated for the treatment of the following infections due to
susceptible strains of sensitive organisms:
Note: Therapy should be guided by bacteriological studies, including
sensitivity tests, and by clinical response.
However, in emergency cases where the causative organism has not been
identified, therapy with amoxicillin
may be useful. Clinical judgement will decide whether combination with
another antibiotic would provide a
sufficiently broad spectrum of activity pending sensitivity test
results.
SKIN AND SKIN STRUCTURE: Staphylococcus, non-penicillinase producing;
Streptococcus; _E.coli _(see section 5.1
PHARMODYNAMIC PROPERTIES - MICROBIOLOGY)._ _
RESPIRATORY
(ACUTE
AND
CHRONIC):
_H.influenzae_,
Streptococcus;
S_.pneumoniae; _
staphylococcus,
non-
penicillinase-producing; _E.coli _(see section 5.1 PHARMODYNAMIC
PROPERTIES - MICROBIOLOGY).
GENITOURINARY
TRACT
(COMPLICATED
AND
UNCOMPLICATED,
ACUTE
AND
CHRONIC):
_E.coli _
(see
section
5.1
PHARMODYNAMIC PROPERTIES - Microbiology), _P.mirabilis _and
_S.faecalis._
GONORRHOEA: _N.gonorrhoeae _(non-penicillinase producing).
2
PROPHYLAXIS OF ENDOCARDI