Azactam 1g powder for injection vial

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

aztreonam, Quantity: 1 g

متاح من:

Bristol-Myers Squibb Australia Pty Ltd

الشكل الصيدلاني:

Injection, powder for

تركيب:

Excipient Ingredients: arginine

طريقة التعاطي:

Intramuscular, Intravenous

الوحدات في الحزمة:

10 x 1 g

الفئة:

Medicine Registered

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

INDICATIONS AS AT 23 MAY 1991: 1. Azactam is indicated for use as a single agent in the treatment of infections known or strongly suspected to be due to susceptible gram negative aerobes, such as urinary tract infection, gonorrhoea, etc. 2. In combination with other suitable antibiotics to treat serious infections due to problem organisms known or likely to be susceptible to aztreonam. Some patients with serious Pseudomonas infections may benefit from concurrent use of Azactam and an aminoglycoside because of synergistic action. However, this enhanced activity is not predictable. If such concurrent therapy is considered in patients with serious infections, susceptibility tests should be performed in vitro to determine the activity of the drugs in combination. Because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics, renal function should be monitored according to the aminoglycoside manufacturer's prescribing information, especially if high dosages of the aminoglycoside are to be u

ملخص المنتج:

Visual Identification: White to off-white, free flowing powder; Container Type: Vial; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

1991-09-05

نشرة المعلومات

AZACTAM
®
_Aztreonam (azz-TREE-oh-nam)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AZACTAM.* 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 AZACTAM
against the benefits that are expected.
This leaflet does not contain
everything about AZACTAM. Your
doctor has been provided with full
information and can answer any
questions you may have. Follow your
doctor's advice even if it differs from
what is in this leaflet.
Please read this leaflet carefully and
keep it in a safe place so you may
refer to it later.
WHAT AZACTAM IS
USED FOR
AZACTAM is used for the treatment
of serious infections caused by
bacteria. AZACTAM may be used in
the treatment of infections present in
various parts of the body and
sometimes AZACTAM is given with
other antibiotics.
Your doctor may have prescribed
AZACTAM for another use. Ask
your doctor if you have any questions
about why AZACTAM was
prescribed for you.
_HOW AZACTAM WORKS_
AZACTAM works by killing or
preventing the growth of the bacteria
that is causing your infection.
The use of AZACTAM to treat your
condition can lead to side-effects,
which are discussed below.
_HOW AZACTAM IS USED_
AZACTAM will be administered as
an injection or infusion in a hospital
or clinic. Your doctor or nurse will
administer AZACTAM to you.
AZACTAM may be used alone or
with other medicines.
BEFORE YOU RECEIVE
AZACTAM
_WHEN YOU MUST NOT TAKE_
_AZACTAM:_
•
You must not take AZACTAM if
you have a history of severe
allergic reactions to AZACTAM
or to any of the ingredients listed
at the end of this leaflet.
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO:
•
any other medicines, particularly
antibiotics
•
any other substances, such as
foods, preservatives or dyes.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY MEDICAL CONDITIONS,
ESPECIALLY THE FOLLOWING:
•
You have diarrhoea or usually get
diarrhoea when you take
antibiotics or have ever suffered

خصائص المنتج

AU_PI_AZACTAM_V7.0
1
AUSTRALIAN PRODUCT INFORMATION – AZACTAM
®
(AZTREONAM)
1
NAME OF THE MEDICINE
Aztreonam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AZACTAM 1 g powder for injection.
AZACTAM for injection is sodium free and contains approximately 814mg
L-arginine per g of
aztreonam. The pH of AZACTAM solution, depending on the type and
amount of diluent used, ranges
between 4.5 and 7.5.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection. A white to off-white, free flowing sterile
non-pyrogenic powder blend of
aztreonam and L-arginine which upon reconstitution is intended for
intravenous or intramuscular
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AZACTAM is indicated for use:
•
as a single agent in the treatment of infections known or strongly
suspected to be due to
susceptible gram negative aerobes, such as urinary tract infection,
gonorrhoea, etc.
•
in combination with other suitable antibiotics to treat serious
infections due to problem
organisms known or likely to be susceptible to aztreonam.
*
•
meningitis caused by Haemophilus influenzae or Neisseria meningitidis.
AZACTAM should
not be used alone, but only in combination with other suitable
antibiotics, in cases where
meningitis is known or presumed to be due to the above organisms.
Appropriate therapy
should be instituted when results of sensitivity tests are known.
*
Some patients with serious Pseudomonas infections may benefit from
concurrent use of AZACTAM and an
aminoglycoside because of synergistic action. However, this enhanced
activity is not predictable. If such
concurrent therapy is considered in patients with serious infections,
susceptibility tests should be performed in
vitro to determine the activity of the drugs in combination. Because
of the potential nephrotoxicity and
ototoxicity of aminoglycoside antibiotics, renal function should be
monitored according to the aminoglycoside
manufacturer's prescribing information, especially if high dosages of