CURAM 1000/200 amoxicillin (as sodium) 1000 mg and clavulanic acid (as potassium clavulanate) 200 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin sodium, Quantity: 1.06 g (Equivalent: amoxicillin, Qty 1 g); potassium clavulanate, Quantity: 238.3 mg (Equivalent: clavulanic acid, Qty 200 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous Infusion, Intravenous

Units in package:

1, 5, 10, 20, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CURAM is an antibiotic alternative to narrow spectrum and broad-spectrum antibiotics for the treatment of polymicrobial infections; especially in mixed Gram negative and Gram positive infections, and situations where microbial confirmation has not yet been obtained.,Infections caused by amoxicillin susceptible organisms are amenable to CURAM treatment due to its amoxicillin content.,Infections caused by beta-lactamase producing amoxicillin resistant organisms are also amenable to CURAM due to its clavulanic acid content.,Susceptibility to CURAM will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. Amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.,CURAM is indicated for the short term treatment of serious bacterial infections such as:,? Upper Respiratory Tract Infections (including ENT): e.g. mastoiditis, tonsillitis, otitis media, epiglotitis and sinusitis when accompanied by severe signs and symptoms,? Lower Respiratory Tract Infections: e.g. acute exacerbations of chronic bronchitis, lobar, broncho-pneumonia and community acquired pneumonia,? Genito-urinary Tract Infections: e.g. cystitis, urethritis, pyelonephritis, , female genital infections,? Gastrointestinal infections: e.g. intra-abdominal sepsis, peritonitis.,? Skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, severe dental abscess,? Other Infections e.g. septic abortion, puerperal sepsis, post-surgical infections.,? CURAM is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastrointestinal surgery.

Product summary:

Visual Identification: Type II colourless glass vials with a nominal capacity of 20 ml closed with rubber stopper and a flip-off cap.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-09-20

Patient Information leaflet

Curam

1
CURAM
®
_ AMOXICILLIN AND CLAVULANIC ACID POWDER FOR INJECTION_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This
leaflet
answers
some
common questions about
Curam
injection.
It
does
not
contain
all
the
available information.
It does not
take the
place of
talking
to
your
doctor
or
pharmacist.
All
medicines
have
risks
and
benefits. In deciding to give you.
Curam, your doctor has
weighed
the risks of you taking
Curam
against the
benefits it will 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 CURAM IS
USED FOR
This product contains two active
ingredients.
One
of
these
is
a
penicillin called amoxicillin and
the other is clavulanic acid.
Curam injection belongs to
the
penicillin group of
antibiotics.
This product is used to treat a
wide range of infections caused
by bacteria. These infections
may affect the respiratory tract
(bronchitis, pneumonia,
tonsillitis, sinusitis), genito-
urinary tract (cystitis, urethritis,
pyelonephritis, gonorrhoea),
gastrointestinal tract (peritonitis,
intra-abdominal
sepsis) the ears (otitis media)
and the skin. This product can
also
be
used
to
prevent
infections
in
major
surgical
procedures.
Amoxicillin/
clavulanic
acid
injection
works by killing the
bacteria
that
cause
these
infections.
This
medicine
will
not
work
against
infections
caused by viruses such as colds
or the flu.
Your
doctor
may
have
prescribed
this
medicine
for
another reason.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
IT
_WHEN YOU MUST NOT USE _
_CURAM_
_ _
1.
DO NOT USE CURAM
IF YOU
ARE
ALLERGIC
TO
PENICILLINS
AND
CEPHALOSPORINS
OR
CLAVULANIC ACID.
2.
DO NOT USE CURAM
IF YOU
HAVE A PREVIOUS
HISTORY OF
AMOXICILLIN/
CLAVULANIC ACID
ASSOCIATED
JAUNDICE
/
HEPATIC
DYSFUNCTION.
3.
YOU HAVE HAD AN ALLERGIC
REACTION
TO
CEPHALOSPORIN
ANTIBIOTICS. YOU MAY HAVE
AN
INCREASED
CHANCE
OF
BEING ALLERGIC TO CURA

Summary of Product characteristics

20180322-Curam-pi
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
CURAM
®
POWDER
FOR INJECTION
(
AMOXICILLIN
/
CLAVULANIC ACID
)
1
NAME OF THE MEDICINE
Amoxicillin sodium/Potassium clavulanate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Curam 500/100 powder for injection consists of vials of sterile white
to off-white powder
providing amoxicillin sodium equivalent to 500 mg amoxicillin and
potassium
clavulanate
equivalent to 100 mg clavulanic acid. Each vial contains 0.5 mmoL
(19.6 mg) of
potassium
and 1.4 mmoL (31.4 mg) of sodium.
Curam 1000/200 powder for injection consists of vials of sterile white
to off-white powder
providing amoxicillin sodium equivalent to 1000 mg amoxicillin and
potassium clavulanate
equivalent to 200 mg clavulanic acid. Each vial contains 1.0 mmoL
(39.3 mg) of potassium
and 2.7 mmoL (62.9 mg) of sodium.
Curam 2000/200 powder for injection consists of vials of sterile white
to off-white powder
providing amoxicillin sodium equivalent to 2000 mg amoxicillin and
potassium clavulanate
equivalent to 200 mg clavulanic acid. Each vial contains 1.0 mmoL
(39.3 mg) of potassium
and 5.5 mmoL (125.9 mg) of sodium.
Curam powder for injection is a combination product containing the
semisynthetic antibiotic,
amoxicillin sodium and the β-lactamase inhibitor, potassium
clavulanate (as the potassium
salt of clavulanic acid).
Amoxicillin sodium is a white or almost white, crystalline powder,
very hygroscopic, very
soluble in water. A 1% solution in water has a pH of 8.0 to 10.0.
Potassium clavulanate is a white or almost white, hygroscopic,
crystalline powder and is freely
soluble in water. A 1% solution in water has a pH of 5.5 to 8.0.
Curam contains no other excipients.
3
PHARMACEUTICAL FORM
Curam 500 mg/100 mg, 1000 mg/200 mg and 2000 mg/200 mg powder for
injection consists of
vials of sterile white to off-white powder
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Curam is an antibiotic alternative to narrow spectrum and
broad-spectrum antibiotics for the
treatment of polymicrobial infections; especia