AMOXIL amoxicillin 250mg (as trihydrate) capsule blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

amoxicillin trihydrate, Quantity: 286.95 mg (Equivalent: amoxicillin, Qty 250 mg)

Beschikbaar vanaf:

Aspen Pharmacare Australia Pty Ltd

INN (Algemene Internationale Benaming):

amoxicillin trihydrate

farmaceutische vorm:

Capsule, hard

Samenstelling:

Excipient Ingredients: erythrosine; iron oxide yellow; titanium dioxide; magnesium stearate; Gelatin; indigo carmine; purified talc; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide

Toedieningsweg:

Oral

Eenheden in pakket:

20, 30, 3 - physician's starter pack

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

INDICATIONS AS AT 14TH FEBRUARY 2005: 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 Microbiology), P.mirabilis and S.faecalis. Gonorrhoea: N.gonorrhoeae (non-penicillinase producing). Prophylaxis of endocarditis: AMOXIL 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.

Product samenvatting:

Visual Identification: A size '2' hard gelatin capsule with yellow body and maroon cap printed with 'AM250' on cap and body in white ink linearly and containing white/off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 34 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Licence status A

Autorisatie datum:

2016-06-22

Bijsluiter

1
AMOXIL
®
ADULT PREPARATIONS
_Amoxicillin (as trihydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take AMOXIL.
This leaflet answers some
common questions about
AMOXIL. 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
AMOXIL against the risks this
medicine could have for you.
Take AMOXIL 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 IS AMOXIL USED
FOR?
AMOXIL contains a penicillin
called amoxicillin (as trihydrate)
as the active ingredient.
AMOXIL belongs to a group of
medicines called penicillins
AMOXIL 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.
AMOXIL works by killing the
bacteria that cause these
infections. AMOXIL can also be
used to prevent infection.
Your doctor may have prescribed
AMOXIL for another reason.
There is no evidence that AMOXIL
is addictive.
BEFORE YOU TAKE
AMOXIL
_ _
_DO NOT TAKE AMOXIL IF: _
•
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
AMOXIL.
•
you have ever had an allergic
reaction to amoxicillin or any
of the ingredients listed toward
the end of this leaflet. (See
“Ingredients”)
•
the expiry date (EXP) printed
on the pack has passed.
•
the packaging is torn or shows
signs of tampering.
_TELL YOUR DOCTOR IF: _
•
you are allergic to foods, dyes,
preservatives or any other
medicines.
•
you have ever had an allergi

Productkenmerken

Amoxil-Product Information
1
AUSTRALIAN PRODUCT INFORMATION
AMOXIL (AMOXICILLIN TRIHYDRATE)
CAPSULES AND POWDER FOR ORAL LIQUID
1
NAME OF THE MEDICINE
Amoxicillin trihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AMOXIL
250
and
500
mg capsule contains amoxicillin trihydrate equivalent to either 250
mg or 500 mg of amoxicillin
Each bottle of AMOXIL powder for oral liquid contains amoxicillin
trihydrate equivalent to 125
mg, 250 mg per 5 mL or 100 mg per 1 mL, of amoxicillin when
reconstituted.
Excipients with known effect: AMOXIL SUGAR FREE SYRUP and AMOXIL FORTE
SUGAR FREE
SYRUP - benzoates and saccharin. AMOXIL PAEDIATRIC DROPS - benzoates.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AMOXIL
250
AND
500
MG
CAPSULES:
250 MG: A size '2' hard gelatin capsule with yellow body and maroon
cap printed with 'AM250'
on cap and body in white ink linearly and containing white/off white
powder
500 MG: A size '0EL' hard gelatin capsule with yellow body and maroon
cap printed with 'AM500'
on cap and body in white ink linearly and containing white/off white
powder
AMOXIL
SUGAR
FREE
SYRUP AMOXICILLIN 125MG/5ML (AS TRIHYDRATE) POWDER FOR ORAL LIQUID
BOTTLE: White free flowing powder. Each 5 mL of the off-white
reconstituted oral suspension
contains amoxicillin trihydrate equivalent to amoxicillin 125mg.
AMOXIL
FORTE
SUGAR
FREE
SYRUP
AMOXICILLIN 250MG/5ML (AS TRIHYDRATE) POWDER FOR
ORAL LIQUID BOTTLE: White free flowing powder. Each 5 mL of the
off-white reconstituted oral
suspension contains amoxicillin trihydrate equivalent to amoxicillin
250mg.
AMOXIL PAEDIATRIC DROPS
AMOXICILLIN 100MG/ML (AS TRIHYDRATE) POWDER FOR ORAL LIQUID
BOTTLE: White free flowing powder. Each 1 ml of off-white
reconstituted oral suspension contains
amoxicillin trihydrate equivalent to Amoxicillin 1OOmg.
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:
Amoxil-Product Information
2
Note: