TOBRAMYCIN VIATRIS tobramycin 80 mg/2 mL injection, solution vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

tobramycin, Quantity: 40 mg/mL

Tilgjengelig fra:

Alphapharm Pty Ltd

INN (International Name):

Tobramycin

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: sulfuric acid; sodium hydroxide; water for injections; disodium edetate; sodium bisulfite

Administreringsrute:

Intramuscular, Intravenous

Enheter i pakken:

5 vials, 1 vial, 10 vials

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Tobramycin is indicated in the treatment of the following serious infections caused by susceptible micro-organisms: - central nervous system infections, including meningitis; septicaemia and neonatal sepsis; gastro-intestinal infections, including peritonitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis; lower respiratory tract infections, including pneumonia, bronchopneumonia and acute bronchitis; bone, skin and skin structure infections, including burns.,Tobramycin may be considered in serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use. Aminoglycosides, including tobramycin, are not indicated in uncomplicated initial episodes or urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.,Bacterial cultures should be obtained prior to and during treatment to isolate and identify aetiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organism is resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom gram negative septicaemia, neonatal sepsis, or meningitis is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, tobramycin therapy may be initiated before results of susceptibility studies are obtained. The decision to continue tobramycin therapy should be based upon the results of susceptibility studies, severity of the infection, and the important additional concepts discussed under PRECAUTIONS.

Produkt oppsummering:

Visual Identification: A clear, colourless liquid free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-02-25

Informasjon til brukeren

TOBRAMYCIN MYLAN
_tobramycin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TOBRAMYCIN
MYLAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking TOBRAMYCIN
MYLAN against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TOBRAMYCIN
MYLAN IS USED FOR
Tobramycin is an antibiotic that
belongs to a group of medicines
called aminoglycoside antibiotics.
Tobramycin works by preventing
bacteria from growing and thereby
killing them. Tobramycin is used to
treat serious bacterial infections,
including:
•
meningitis (infection of the brain)
•
septicaemia (infection of the
blood)
•
respiratory tract infections
•
gastrointestinal tract infections
•
skin and skin structure infections,
including infected burns
•
bone infections
•
urinary tract infections.
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 available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
TOBRAMYCIN MYLAN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
TOBRAMYCIN MYLAN IF YOU
HAVE AN ALLERGY TO:
•
sulfites
•
any medicine containing
tobramycin
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such
as amikacin, gentamycin and
neomycin
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
YOU MUST NOT BE GIVEN TOBRAMYCIN
IF YOU HAVE A HISTORY OF
HYPERSENSITIVITY OR SERIOUS TOXIC
REACTIONS (SUCH AS HEARING LOSS OR
KIDNEY PROBLEMS) TO TOBRAMYCIN OR
ANY OTHE

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
TOBRAMYCIN MYLAN
_Tobramycin Solution for injection _
1
NAME OF THE MEDICINE
Tobramycin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tobramycin is a clear, colorless sterile liquid.
Each vial contains 80 mg of tobramycin as the active ingredient.
Excipients with known effect: sulfites and residual apramycin and
kanamycin B.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TOBRAMYCIN MYLAN is a clear, colourless liquid free from visible
particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tobramycin
is
indicated
in
the
treatment
of
the
following
serious
infections
caused
by
susceptible
micro-organisms:
•
central nervous system infections, including meningitis;
•
septicaemia and neonatal sepsis;
•
gastro-intestinal infections, including peritonitis;
•
complicated and recurrent urinary tract infections such as
pyelonephritis and cystitis;
•
lower respiratory tract infections, including pneumonia,
bronchopneumonia and acute bronchitis;
•
bone, skin and skin structure infections, including burns.
Tobramycin may be considered in serious staphylococcal infections for
which penicillin or other less
potentially toxic drugs are contraindicated and when bacterial
susceptibility testing and clinical judgement
indicate its use. Aminoglycosides, including tobramycin, are not
indicated in uncomplicated initial episodes
or urinary tract infections unless the causative organisms are not
susceptible to antibiotics having less potential
toxicity.
Bacterial cultures should be obtained prior to and during treatment to
isolate and identify aetiologic organisms
and to test their susceptibility to tobramycin. If susceptibility
tests show that the causative organism is resistant
to tobramycin, other appropriate therapy should be instituted. In
patients in whom gram negative septicaemia,
neonatal sepsis, or meningitis is suspected, including those in whom
concurrent therapy with a penicillin or
cephalosporin and an aminoglycoside may be indicated,