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

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

tobramycin, Quantity: 80 mg

から入手可能:

Pfizer Australia Pty Ltd

医薬品形態:

Injection, solution

構図:

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

投与経路:

Intravenous, Intramuscular

パッケージ内のユニット:

2mL x 5

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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

製品概要:

Visual Identification: Clear colourless solution, free from visible impurities; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius

認証ステータス:

Registered

承認日:

1991-07-09

情報リーフレット

TOBRAMYCIN PF
_tobramycin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tobramycin PF.
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 PF
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 PF
IS USED FOR
Tobramycin PF belongs to a group of
medicines known as aminoglycoside
antibiotics. Aminoglycoside
antibiotics work by preventing
bacteria from growing thereby killing
them.
Tobramycin PF 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 PF
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN TOBRAMYCIN
PF IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
tobramycin
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such
as aminoglycoside antibiotics e.g.
gentamicin, streptomycin,
amikacin or neomycin.
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
PF IF YOU HAVE EXPERIENCED SERIOUS
REACTIONS (SUCH AS HEARING LOSS OR
KIDNEY PROBLEMS) TO TOBRAMYCIN OR
OTHER

製品の特徴

Version: pfptobai10922
Supersedes: pfptobai10821
Page 1 of 17
AUSTRALIAN
PRODUCT
INFORMATION
–
TOBRAMYCIN PF (TOBRAMYCIN SULFATE)
1.
NAME OF THE MEDICINE
Tobramycin (as tobramycin sulfate)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each steriluer of Tobramycin PF contains 80 mg/2 mL tobramycin (as
tobramycin sulfate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Tobramycin PF is a clear, colourless, sterile, preservative-free
solution, free from visible
impurities.
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.
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, neonatal sepsis or meningitis is suspected, including
those in whom concurrent
Version: pfptobai10922
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