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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

vancomycin hydrochloride, Quantity: 1025.2 mg

Disponible depuis:

Baxter Healthcare Pty Ltd

forme pharmaceutique:

Injection, powder for

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide

Mode d'administration:

Oral, Intravenous

Unités en paquet:

10 vials

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

VANCOMYCIN BAXTER is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.,VANCOMYCIN BAXTER is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who have 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 BAXTER 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., S. faecalis), vancomycin is effective only in combination with an aminoglycoside. Vancomycin is effective for the treatment of diphtheroid endocarditis. VANCOMYCIN BAXTER is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.,The effectiveness of vancomycin has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia and, skin and skin structure infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.,Specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.,Vancomycin should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by C. difficile). Parenteral administration of vancomycin 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.

Descriptif du produit:

Visual Identification: white to tan powder or porous cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2023-06-16

Notice patient

VANCOMYCIN BAXTER
1
VANCOMYCIN BAXTER
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 BAXTER?
VANCOMYCIN BAXTER contains the active ingredient Vancomycin
hydrochloride. Vancomycin is an antibiotic used to treat
serious infections caused by bacteria (germs).
For more information, see Section 1. Why am I using VANCOMYCIN BAXTER?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VANCOMYCIN BAXTER?
Do not use if you have ever had an allergic reaction to VANCOMYCIN
BAXTER, to other similar medicines 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 BAXTER? 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 BAXTER?
•
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
BAXTER?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VANCOMYCIN BAXTER?
THINGS YOU
SHOULD DO
•
Tell your doctor if you experience any problems with this medicine.
•
Remind any doctor, dentist or pharmacist you visit that you are using
vancomycin.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how vancomycin affects you.
LOOKING AFTER
YOUR MEDICINE
•
This medicine will generally be stored in the pharmacy or on the ward
(below 25°C and protected
from light).
For more information,

Résumé des caractéristiques du produit

Version: 2.0
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION –
VANCOMYCIN BAXTER (VANCOMYCIN
HYDROCHLORIDE)
1. NAME OF THE MEDICINE
Vancomycin hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of VANCOMYCIN BAXTER contains 500 mg or 1000 mg of
vancomycin (as the
hydrochloride).
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Powder for injection is a white to tan powder or porous cake.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VANCOMYCIN BAXTER is indicated for potentially life threatening
infections which cannot
be treated with another effective, less toxic antimicrobial drug,
including the penicillins and
cephalosporins.
VANCOMYCIN
BAXTER
is
useful
in
therapy
of
severe
staphylococcal
(including
methicillin-resistant staphylococcal) infections in patients who
cannot receive or who have
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 BAXTER 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.,
_S. _
_faecalis_
), vancomycin is effective only in combination with an aminoglycoside.
Vancomycin
is effective for the treatment of diphtheroid endocarditis. VANCOMYCIN
BAXTER is used
in combination with rifampicin, an aminoglycoside, or both in early
onset prosthetic valve
endocarditis caused by
_S_
.
_epidermidis_
or diphtheroids.
The effectiveness of vancomycin has been documented in other
infections due to staphylococci
including osteomyelitis, pneumonia, septicaemia and, skin and skin
structure infections. When
staphylococcal infections are localised and purulent, antibiotics are
used as adjuncts to
appropriate surgical measures.
Specimens for bacteriological cultures should be obtained in order to
isolate and identify
causative organisms and to determine their susce