AMCLAVOX DUO FORTE 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

amoxicillin trihydrate, Quantity: 1004.31 mg; potassium clavulanate, Quantity: 151.917 mg

Предлага се от:

Arrotex Pharmaceuticals Pty Ltd

INN (Международно Name):

amoxicillin trihydrate,potassium clavulanate

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; dichloromethane; microcrystalline cellulose; sodium starch glycollate; isopropyl alcohol; titanium dioxide; hypromellose; propylene glycol; purified talc; ethylcellulose

Начин на приложение:

Oral

Броя в опаковка:

10 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

AMCLAVOX DUO FORTE 875/125 tablets are indicated for short-term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to Microbiology):,Urinary Tract Infections (complicated and uncomplicated),Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis,Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis.,Skin and Skin Structure Infection.,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed above, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.

Каталог на резюме:

Visual Identification: White colored capsule shaped film coated tablet debossed with 'I 07' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2017-08-07

Листовка

AMCLAVOX DUO 500/125 & AMCLAVOX DUO FORTE 875/125 TABLETS
Amoxicillin and clavulanic acid
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you take
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets.
This leaflet answers some
common questions about
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets. 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 AMCLAVOX DUO
& AMCLAVOX DUO
FORTE tablets against the
risks this medicine could
have for you.
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 ARE AMCLAVOX
DUO & AMCLAVOX
DUO FORTE TABLETS
USED FOR?
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets contain two
active ingredients. One of
these is a penicillin called
amoxicillin and the other is
clavulanic acid.
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets belong to
the penicillin group of
antibiotics. AMCLAVOX
DUO & AMCLAVOX
DUO FORTE tablets are
used for the short term
treatment of a wide range
of infections caused by
bacteria. These infections
may affect the chest (e.g.
bronchitis or pneumonia),
bladder (e.g. cystitis),
sinuses (e.g. sinusitis), the
ears (e.g. otitis media) or
the skin.
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets work by
killing the bacteria that
cause these infections.
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets will not
work against infections
caused by viruses such as
colds or the flu.
Your doctor may prescribe
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets for another
use. If you want more
information, ask your
doctor.
There is no evidence that
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE tablets are
addictive.
BEFORE YOU TAKE
AMCLAVOX DUO &
AMCLAVOX DUO
FORTE TABLETS
_Do not take AMCLAVOX _
_DUO & AMCLAVOX _
_DUO FORTE tablets if: _
•
You hav

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION – AMCLAVOX DUO 500/125 &
AMCLAVOX DUO FORTE 875/125
(AMOXICILLIN AND CLAVULANIC ACID) TABLETS
1
NAME OF THE MEDICINE
Amoxicillin trihydrate and potassium clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMCLAVOX DUO 500 /125 tablets contain amoxicillin (as trihydrate) 500
mg and clavulanic acid (as
potassium clavulanate) 125 mg.
AMCLAVOX DUO FORTE 875 /125 tablets contain amoxicillin (as
trihydrate) 875 mg and clavulanic
acid (as potassium clavulanate) 125 mg.
AMCLAVOX DUO 500 / 125 and AMCLAVOX DUO FORTE 875 / 125 contain 25 mg
potassium per
tablet.
For the full list of excipients see SECTION 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
AMCLAVOX DUO 500 /125 tablets are white coloured capsule shaped film
coated tablets debossed
with ‘Ɩ 06’ on one side and plain on other side.
AMCLAVOX DUO FORTE 875 /125 tablets are white coloured capsule shaped
film coated tablets
debossed with ‘Ɩ 07’ on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AMCLAVOX DUO tablets are indicated for short term treatment of
bacterial infections at the following
sites when caused by sensitive organisms (refer to Microbiology):
•
Urinary Tract Infections (complicated and uncomplicated)
•
Lower Respiratory Tract Infections, including community acquired
pneumonia and acute
exacerbations of chronic bronchitis.
•
Upper Respiratory Tract Infections, such as sinusitis, otitis media
and recurrent tonsillitis.
•
Skin and Skin Structure infections.
Appropriate
culture
and
susceptibility
studies
should
be
performed
to
identify
the
causative
organism(s) and determine its (their) susceptibility to amoxicillin
and clavulanic acid tablets. However,
when there is reason to believe an infection may involve any of the
β-lactamase producing organisms
listed above, therapy may be instituted prior to obtaining the results
from bacteriological and
susceptibility studies. Once these results are known, therapy should
be adjusted if appropriate.
2
The treatment of mixed