Pfizer (Australia) TOBRAMYCIN (as sulfate) 80 mg/2 mL injection BP ampoule

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

tobramycin, Quantity: 80 mg

Доступна с:

Pfizer Australia Pty Ltd

ИНН (Международная Имя):

Tobramycin

Фармацевтическая форма:

Injection, solution

состав:

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

Администрация маршрут:

Intravenous, Intramuscular

Штук в упаковке:

5 x 2mL Ampoules

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

For the treatment of serious infections of the following type where they are caused by susceptible organisms: Skin and skin structure infections including burns, bone infections; gastrointestinal infections including peritonitis; central nervous system infections including meningitis, septicaemia and neonatal sepsis; lower respiratory tract infections including pneumonia, bronchopneumonia, and acute bronchitis; complicated and recurrent urinary tract infections such as pyelonephritis and cystitis.,Aminoglycosides, including tobramycin, should not be used in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to other less toxic antibiotics.,Tobramycin can be used in serious staphylococcal infections for which penicillin or other less toxic drugs are contraindicated and where susceptibility testing and clinical judgement indicate its use. If susceptibility tests show a resistance to tobramycin in the causative organisms other appropriate therapy should be instituted.,Note that bacterial cultures should bo obtained before and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If the organisms are resistant, 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 cefalosporin 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, the severity of infection and the important additional concepts discussed in the Product Information leaflet.

Обзор продуктов:

Visual Identification: Clear, colourless to pale brown aqueous solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

2004-05-04

тонкая брошюра

TOBRAMYCIN
INJECTION
_tobramycin sulfate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tobramycin
Injection.
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
Injection against the benefits this
medicine is expected to 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 TOBRAMYCIN
INJECTION IS USED FOR
Tobramycin Injection belongs to a
group of medicines known as
aminoglycoside antibiotics.
Aminoglycoside antibiotics work by
preventing bacteria from growing,
thereby killing them.
Tobramycin Injection is used to treat
serious bacterial infections in many
different parts of the body such as:
•
meningitis (infection of the brain)
•
septicaemia (infection of the
blood)
•
respiratory tract infections (such
as pneumonia, bronchitis)
•
gastrointestinal tract infections
•
skin and bone infections,
including burns
•
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 INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN TOBRAMYCIN
INJECTION IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
tobramycin
•
any other similar medicines such
as aminoglycoside antibiotics e.g.
gentamicin, streptomycin,
amikacin or neomycin
•
any of the ingredients listed at the
end of this leaflet
•
sulfites.
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
INJECTION IF YOU HAVE EXPERIENC

Характеристики продукта

Version: pfptobri10922
Supersedes: pfptobri10821
Page 1 of 17
AUSTRALIAN
PRODUCT
INFORMATION
–
TOBRAMYCIN
INJECTION
(TOBRAMYCIN
SULFATE)
1.
NAME OF THE MEDICINE
Tobramycin (as tobramycin sulfate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tobramycin Injection is a sterile solution containing tobramycin (as
tobramycin sulfate)
80 mg/2 mL.
EXCIPIENT(S) WITH KNOWN EFFECT
•
sulfites
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Tobramycin Injection is a clear, colourless to pale brown, sterile
aqueous solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of serious infections of the following type where
they are caused by
susceptible organisms:
•
skin and skin structure infections including burns, bone infections
•
gastrointestinal infections including peritonitis
•
central nervous system infections including meningitis, septicaemia
and neonatal sepsis
•
lower respiratory tract infections including pneumonia,
bronchopneumonia, and acute
bronchitis
•
complicated and recurrent urinary tract infections such as
pyelonephritis and cystitis
Aminoglycosides, including tobramycin, should not be used in
uncomplicated initial episodes
of urinary tract infection unless the causative organisms are not
susceptible to other less toxic
antibiotics.
Tobramycin can be used in serious staphylococcal infections for which
penicillin or other less
toxic drugs are contraindicated and where susceptibility testing and
clinical judgement indicate
its use. If susceptibility tests show a resistance to tobramycin in
the causative organisms other
appropriate therapy should be instituted.
Version: pfptobri10922
Supersedes: pfptobri10821
Page 2 of 17
Note that bacterial cultures should be obtained before and during
treatment to isolate and
identify etiologic organisms and to test their susceptibility to
tobramycin. If the organisms are
resistant, other appropriate therapy should be instituted. In patients
in whom Gram-negative
septicaemia