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

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

vancomycin hydrochloride, Quantity: 512.5 mg (Equivalent: vancomycin, Qty 500 mg)

Disponibil de la:

Alphapharm Pty Ltd

Forma farmaceutică:

Injection, powder for

Compoziție:

Excipient Ingredients: hydrochloric acid; sodium hydroxide

Calea de administrare:

Oral, Intravenous Infusion

Unități în pachet:

1 vial

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Vancomycin Hydrochloride for Intravenous Infusion is indicated for potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial medicine, 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 Enterococcus 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.

Rezumat produs:

Visual Identification: Off white to light tan colored lyophilized plug or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-04-07

Prospect

VANCOMYCIN VIATRIS
_contains the active ingredient vancomycin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vancomycin Viatris.
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 taking Vancomycin
Viatris against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT VANCOMYCIN
VIATRIS IS USED FOR
Vancomycin Viatris is used to treat
severe infections of the body caused
by bacteria, such as:
•
severe staphylococcal infections
•
endocarditis, an infection that
causes inflammation of the lining
of the heart
•
osteomyelitis (bone infection)
•
pneumonia (lung infection)
•
septicaemia (infection of the
blood)
•
skin and skin structure infections
•
infections in the intestines.
It belongs to a group of medicines
called glycopeptide antibiotics. It
works by killing the bacteria that are
causing the infection.
Vancomycin Viatris may be used
alone, or in combination with other
medicines, to treat your condition.
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
VANCOMYCIN VIATRIS
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
VANCOMYCIN VIATRIS IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
vancomycin
•
glycopeptides
•
any of the ingredients listed at the
end of this leaflet.
Some of the 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.
_BEFORE YOU START TO TAKE IT_
TELL YO

Caracteristicilor produsului

AUSTRALIAN PRODUCT INFORMATION
VANCOMYCIN VIATRIS
_Vancomycin (as hydrochloride) powder for injection _
1
NAME OF THE MEDICINE
Vancomycin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VANCOMYCIN VIATRIS 500 mg: Each vial contains 500 mg (500,000 IU) of
vancomycin (as
hydrochloride).
VANCOMYCIN VIATRIS 1000 mg: Each vial contains 1000 mg (1,000,000 IU)
of vancomycin (as
hydrochloride).
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for injection. Off white to light tan coloured lyophilized plug
or powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
_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 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.
Specim