VANCOMYCIN vancomycin (as hydrochloride) 500mg powder for injection vial

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

vancomycin, Quantity: 500 mg

Disponibbli minn:

Pfizer Australia Pty Ltd

Għamla farmaċewtika:

Injection, powder for

Kompożizzjoni:

Excipient Ingredients: sodium hydroxide; hydrochloric acid

Rotta amministrattiva:

Intravenous, Oral

Unitajiet fil-pakkett:

10x500mg, 1X500mg

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

INDICATIONS AS AT 31 October 2003: Vancomycin Hydrochloride for Intravenous Infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. Vancomycin 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 is effective alone or in combination with an aminoglycoside for endocarditis caused by Strep. viridans or Strep. bovis. For endocarditis caused by enterococci (eg Strep. faecalis), vancomycin is effective only in combination with an aminoglycoside. Vancomycin is effective for the treatment of diphtheroid endocarditis. Vancomycin is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by Staph. 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.

Sommarju tal-prodott:

Visual Identification: white to light brown powder or plug in a 10mL Type I clear glass vial, with a rubber stopper closure and aluminium crimp with plastic "filp-off" top; Container Type: Vial; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

1998-03-26

Fuljett ta 'informazzjoni

DBL™ VANCOMYCIN
_Vancomycin Hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Vancomycin. 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. Your doctor has weighed
the risks of you being given
vancomycin against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL
VANCOMYCIN IS USED
FOR
This medicine is used to treat severe
infections caused by bacteria, such
as:
•
staphylococcal infections
(including methicillin resistant
staphylococci )
•
endocarditis (an infection of the
lining of the heart)
•
osteomyelitis (bone infection)
•
pneumonia (lung infection)
•
septicaemia (infection of the
blood)
•
infections of the skin or the skin
structure
•
enterocolitis (infection in the
intestines).
This medicine belongs to a group of
medicines called glycopeptide
antibiotics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL VANCOMYCIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
VANCOMYCIN IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
vancomycin and similar
antibiotics e.g. teicoplanin
You may need to check with your
doctor
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK
TO YOUR DOCTOR.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOO

Karatteristiċi tal-prodott

Version: pfpvanci11121
Supercedes: hhpvanci20721
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Vancomycin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL Vancomycin 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 light brown powder or plug.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Vancomycin is indicated for potentially life threatening
infections which cannot be
treated with another effective, less toxic antimicrobial drug,
including the penicillins and
cephalosporins.
DBL Vancomycin 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.
DBL Vancomycin 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. DBL Vancomycin 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 d