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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amoxicillin sodium, Quantity: 1060.2 mg (Equivalent: amoxicillin, Qty 1000 mg); potassium clavulanate, Quantity: 238.25 mg (Equivalent: clavulanic acid, Qty 200 mg)

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

amoxicillin sodium,potassium clavulanate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

5, 1, 10, 50, 20

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AMOXICLAV JUNO 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 AMOXICLAV JUNO treatment due to its amoxicillin content. Infections caused by ?-lactamase producing amoxicillin resistant organisms are also amenable to AMOXICLAV JUNO due to its clavulanic acid content. Susceptibility to AMOXICLAV JUNO 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. AMOXICLAV JUNO 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. ? AMOXICLAV JUNO is indicated for prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications eg. gastronitestinal surgery.

Product summary:

Visual Identification: white to off-white sterile powder; Container Type: Vial; Container Material: Glass Type III Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-01-18

Patient Information leaflet

_Amoxiclav Juno Consumer Medicines Information Juno Pharmaceuticals
Pty Ltd _
78.JU.M.1.2
1
AMOXICLAV JUNO
_Amoxicillin and clavulanic acid _
_Powder for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Amoxiclav Juno 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.
Amoxiclav Juno, your doctor has
weighed the risks of you taking
Amoxiclav Juno 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 AMOXICLAV
JUNO IS USED FOR
This product contains two active
ingredients. One of these is a
penicillin called amoxicillin and
the other is clavulanic acid.
Amoxiclav 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 _
_AMOXICLAV JUNO _
1.
DO NOT USE AMOXICLAV JUNO
IF YOU ARE ALLERGIC TO
PENICILLINS AND
CEPHALOSPORINS OR
CLAVULANIC ACID.
2.
DO NOT USE AMOXICLAV JUNO
IF YOU HAVE A PREVIOUS
HISTORY OF AMOXICILLIN /
CLAVULANIC ACID ASSOCIATED
JAU

Summary of Product characteristics

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Doc ID #: 78.JU.P.1.3
Page | 1
AUSTRALIAN PRODUCT INFORMATION
AMOXICLAV JUNO 1000/200 AMOXICILLIN (AS SODIUM) 1000 MG AND
CLAVULANIC ACID (AS POTASSIUM CLAVULANATE) 200MG)
AMOXICLAV JUNO 2000/200 AMOXICILLIN (AS SODIUM) 2000 MG AND
CLAVULANIC ACID (AS POTASSIUM CLAVULANATE) 200MG)
AMOXICLAV JUNO 500/100 AMOXICILLIN (AS SODIUM) 500 MG AND
CLAVULANIC ACID (AS POTASSIUM CLAVULANATE) 100MG)
_ _
1 NAME OF THE MEDICINE
Amoxycillin sodium and potassium clavulanate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
AMOXICLAV JUNO 500/100
Amoxiclav Juno 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.
AMOXICLAV JUNO 1000/200:
Amoxiclav Juno 1000/200 Powder for Injection consists of vials of
sterile white to off-white
powder providing amoxicillin sodium equivalent to 1 g 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.
AMOXICLAV JUNO 2000/200:
Amoxiclav Juno 2000/200 Powder for Injection consists of vials of
sterile white to off-white
powder providing amoxicillin sodium equivalent to 2 g 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.
Amoxiclav Juno contains no other excipients.
3. PHARMACEUTICAL FORM
Amoxiclav Juno Powder for Injection consists of vials of sterile white
to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AMOXICLAV JUNO is an antibiotic alternative to narrow spectrum and
broad-spectrum
antibiotics for the treatment of polymicrobial infections; especially
in mixed Gram negative and
e001047
Product information - clean
1.3.1.1 Pg. 1
Juno Pharmaceuticals Pty Ltd
Australian Pr