VANCOMYCIN JUNO vancomycin (as hydrochloride) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vancomycin hydrochloride, Quantity: 952 mg (Equivalent: vancomycin, Qty 1000000 IU)

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

1, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vancomycin JUNO is indicated in potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.,Vancomycin JUNO is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly.,Vancomycin JUNO is effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g. E. faecalis), Vancomycin JUNO is effective only in combination with an aminoglycoside. Vancomycin JUNO is effective for the treatment of diphtheroid endocarditis. Vancomycin JUNO is used in combination with rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.,The effectiveness of Vancomycin JUNO has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.,Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to Vancomycin JUNO.,Vancomycin JUNO should be administered orally for the treatment of Staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis produced by C. difficile. Parenteral administration of Vancomycin JUNO alone is inappropriate for this indication. Vancomycin is not effective by the oral route for other types of infections. For oral administration the parenteral formulation may be used. Some systemic absorption may occur following oral administration in patients with pseudomembranous colitis

Product summary:

Visual Identification: An almost white to light pink homogeneous freeze-dried cake.; Container Type: Vial; Container Material: Glass; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-04-08

Patient Information leaflet

VANCOMYCIN JUNO
1
VANCOMYCIN JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VANCOMYCIN JUNO?
VANCOMYCIN JUNO contains the active ingredient vancomycin
hydrochloride. Vancomycin is an antibiotic used to treat
serious infections caused by bacteria (germs). These infections may
occur in different parts of the body. Vancomycin can also
be used orally to treat serious infections involving the bowel.
For more information, see Section 1. Why am I using VANCOMYCIN JUNO?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VANCOMYCIN JUNO?
Do not use if you have ever had an allergic reaction to vancomycin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
VANCOMYCIN JUNO?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with vancomycin and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE VANCOMYCIN JUNO?
•
Your doctor will decide the appropriate dose for you.
•
A doctor or nurse will usually prepare and administer the injection or
infusion.
•
Follow all instructions given to you by your doctor and pharmacist.
More instructions can be found in Section 4. How do I use VANCOMYCIN
JUNO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING [MEDICINE NAME]?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
vancomycin.
THINGS YOU
SHOULD NOT DO
•
Do not take any anti-diarrhoeal medicine without first checking with
your doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how vancomycin affects you.
Vancomycin may cause dizziness in som

Summary of Product characteristics

Australian Product Information
Product Information v2.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_VANCOMYCIN JUNO (VANCOMYCIN HYDROCHLORIDE) _
_ _
1 NAME OF THE MEDICINE
Vancomycin hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vancomycin
JUNO
is
available
as
sterile
vials
containing
vancomycin
hydrochloride
equivalent to either 500 mg (500,000 IU) or 1 g (1,000,000 IU) of
vancomycin activity.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Powder for injection.
An almost-white to light pink homogenous freeze-dried cake. When
reconstituted in water, it
is a clear solution with a pH range of 2.8 to 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vancomycin JUNO is indicated in potentially life-threatening
infections which cannot be
treated with another effective, less toxic antimicrobial drug,
including the penicillins and
cephalosporins.
Vancomycin JUNO is useful in therapy of severe staphylococcal
(including methicillin-
resistant staphylococcal) infections in patients who cannot receive or
who failed to respond to
the penicillins and cephalosporins or who have infections with
staphylococci that are resistant
to
other
antibiotics.
Once
sensitivity
data
are
available,
therapy
should
be
adjusted
accordingly.
Vancomycin
JUNO
is
effective
alone
or
in
combination
with
an
aminoglycoside
for
endocarditis caused by _S. viridans _or _S. bovis. _For endocarditis
caused by enterococci (e.g.
_E. faecalis_), Vancomycin JUNO is effective only in combination with
an aminoglycoside.
Vancomycin JUNO is effective for the treatment of diphtheroid
endocarditis. Vancomycin
JUNO is used in combination with rifampin, an aminoglycoside, or both
in early-onset
prosthetic valve endocarditis caused by _S. epidermidis _or
diphtheroids.
The effectiveness of Vancomycin JUNO has been documented in other
infections due to
staphylococci including osteomyelitis, pneumonia, septicaemia, and
soft tissue infections.
When staphylococcal infections are localised and purulent, antibiotics
are used as adjuncts
t