DBL TOBRAMYCIN tobramycin 80mg/2mL Injection BP

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: 40 mg/mL

から入手可能:

Pfizer Australia Pty Ltd

医薬品形態:

Injection, solution

構図:

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

投与経路:

Intramuscular, Intravenous

パッケージ内のユニット:

5x80mg/2mL

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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 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, severity of the infection, and the important additional concepts discussed in the Product Information document.

製品概要:

Visual Identification: A clear, colourless solution.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Licence status A

承認日:

2000-08-22

情報リーフレット

DBL ™ TOBRAMYCIN
INJECTION BP
_tobramycin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Tobramycin
Injection BP.
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 DBL
Tobramycin Injection BP 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 IN A SAFE PLACE.
YOU MAY NEED TO READ IT AGAIN.
WHAT DBL TOBRAMYCIN
INJECTION BP IS USED
FOR
Tobramycin is an antibiotic that
belongs to a group of medicines
called aminoglycosides (pronounced
a-my-noe-GLY-koe-sides).
Tobramycin works by preventing
bacteria from growing and thereby
killing them. Tobramycin is used for
the treatment of serious infections
caused by bacteria, 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.
Your doctor may have prescribed
tobramycin for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TOBRAMYCIN
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL TOBRAMYCIN
INJECTION BP
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN DBL
TOBRAMYCIN INJECTION BP IF YOU
HAVE AN ALLERGY TO:
any medicine containing tobramycin
any of the ingredients listed at the
end of this leaflet
any similar medicines such as
amikacin, streptomycin, gentamicin,
or neomycin
•
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
IF YOU HAV

製品の特徴

Version: pfptobdi10922
Superscedes: pfptobdi10721
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ TOBRAMYCIN INJECTION (TOBRAMYCIN)
1.
NAME OF THE MEDICINE
Tobramycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The vials of DBL Tobramycin Injection BP contain 80 mg/2 mL
tobramycin. The vials contain
disodium edetate 0.2 mg, sodium metabisulfite 4.8 mg, sulfuric acid
34.6 mg and water for
injections. In the manufacture of the vials, additional sulfuric acid
and/or sodium hydroxide
may have been added to adjust the pH.
EXCIPIENTS WITH KNOWN EFFECT
•
Sodium metabisulfite
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Tobramycin Injection BP is a clear, colourless solution. The pH of
the solution is
approximately 5.5.
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.
Version: pfptobdi10922
Superscedes: pfptobdi10721
Page 2 of 18
Bacterial cultures should be obtained prior to and during treatment to
isolate and identify
aetiologic organisms and to test their susceptibility to tobramycin