PHARMACLAV 875mg/125mg amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablet bottle pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

amoxicillin trihydrate, Quantity: 1012.617 mg (Equivalent: amoxicillin, Qty 875 mg); potassium clavulanate, Quantity: 149.774 mg (Equivalent: clavulanic acid, Qty 125 mg)

Dostępny od:

Pharmacor Pty Ltd

INN (International Nazwa):

amoxicillin trihydrate,potassium clavulanate

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: microcrystalline cellulose; dichloromethane; sodium starch glycollate type A; magnesium stearate; isopropyl alcohol; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; diethyl phthalate; ethylcellulose

Droga podania:

Oral

Sztuk w opakowaniu:

20 tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

PHARMACLAV 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 (uncomplicated and complicated), 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 PHARMACLAV 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 amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to PHARMACLAV Tablets should not require the addition of another antibiotic due to the amoxycillin content of these products.

Podsumowanie produktu:

Visual Identification: White to off white capsule shaped, biconvex, film coated tablets debossed with AM and CL separated by break line on one side and 1000 on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autoryzacji:

Licence status A

Data autoryzacji:

2013-11-14

Ulotka dla pacjenta

PHARMACLAV
Ver: 03
1
PHARMACLAV
(Amoxicillin & Clavulanic Acid)
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before
you
take
PHARMACLAV tablets.
This
leaflet
answers
some
common
questions
about
PHARMACLAV 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 ne risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits
of
you
taking
PHARMACLAV 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
PHARMACLAV TABLETS
USED FOR?
PHARMACLAV tablets contain
two active ingredients. One of
these
is
a
penicillin
called
amoxycillin
and
the
other
is
clavulanic
acid.
PHARMACLAV tablets belong
to
the
penicillin
group
of
antibiotics.
PHARMACLAV
tablets
are
used for the short term treatment
of
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.
PHARMACLAV
tablets
work
by killing the bacteria that cause
these
infections.
PHARMACLAV tablets will not
work against infections caused
by viruses such as colds or the
flu.
Your
doctor
may
have
prescribed it for another reason.
If
you
want
more
information
ask your doctor.
This medicine is available only
with a doctor’s prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE
PHARMACLAV
TABLETS
_DO NOT TAKE PHARMACLAV _
_TABLETS IF:_

you
have
had
an
allergic
reaction
to
penicillin
or
similar types of antibiotics
(such as cephalosporins) or
any
of
the
ingredients
contained
in
PHARMACLAV
tablets.
_The ingredients are listed at _
_the_
_end of this leaflet. Some _
_of _
_the _
_symptoms _
_of _
_an _
_allergic _
_reaction _
_

Charakterystyka produktu

PHARMACLAV
Ver-04
1
AUSTRALIAN PRODUCT INFORMATION - PHARMACLAV
875MG/125MG TABLETS (AMOXICILLIN AND POTASSIUM CLAVULANATE TABLETS)
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate and Potassium clavulanate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACLAV 875MG/125MG TABLETS
is a combination product containing the semisynthetic
antibiotic, amoxicillin (as the trihydrate) and the β-lactamase
inhibitor, potassium clavulanate (as
the potassium salt of clavulanic acid).
For full list of excipients, see
SECTION 6.1- LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
PHARMACLAV 875 MG/125 MG TABLETS:
White to off white capsule shaped, biconvex, film
coated tablets debossed with
AM
and
CL
separated by breakline on one side and 1000 on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACLAV 875 mg/125 mg tablets are indicated for short term
treatment of bacterial
infections
at
the
following
sites
when
caused
by
sensitive
organisms
(see
SECTION
5.1
PHARMACODYNAMIC PROPERTIES, MICROBIOLOGY
):
Urinary Tract Infections (uncomplicated and complicated)
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 potassium clavulanate
PHARMACLAV
Ver-04
2
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.
The treatment of mixed infections caused by amoxicillin susceptible
organisms and β-lactamase
producing organisms susceptible to amoxicillin and potassium
clavulanate tablets should not
require the additio