Azactam

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

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15-06-2024

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Aztreonam

Tờ rơi thông tin

                                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 hav
                                
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Đặc tính sản phẩm

                                Azactam V4.0 
 
PRODUCT INFORMATION 
 
 
AZACTAM 
 
(AZTREONAM)
 
 
 
APPROVED NAME 
 
Aztreonam 
 
DESCRIPTION 
 
Azactam (aztreonam) is a totally synthetic
monocyclic beta lactam belonging to a new class of 
antibiotics, the monobactams. Chemically, aztreonam is designated
as: 
 
(Z)-2-((((2-amino-4-thiazolyl)-(((2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl) 
carbamoyl)methylene)-amino)oxy)-2-methylpropionic acid. 
 
The structural formula is: 
 
 
 
 
Aztreonam contains a sulphonic acid substituent in the 1-position of the beta-lactam nuclear ring, 
which activates the beta-lactam moiety. It also contains an aminothiazolyl oxime side chain in the 
3-position and a methyl group in the 4-position which confer the specific anti-bacterial spectrum 
and beta-lactamase stability. 
 
Azactam for Injection (Aztreonam  for Injection) is  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.  Azactam  for  Injection  is  sodium  free  and 
contains approximately 814mg L-arginine per gram of aztreonam. The pH of Azactam solution, 
depending on the type and amount of diluent used, ranges between
4.5 and 7.5. 
 
 
 
 
 
Azactam V4.0 
- 2 - 
PHARMACOLOGY 
 
_Pharmacokinetics _
 
Azactam is not intended for oral administration as it is not absorbed from the gastrointestinal 
tract. Single 30-minute intravenous infusions of 0.5, 1 and 2gm doses of Azactam in healthy 
volunteers produced serum levels of 54, 90 and 204mcg/mL, respectively, immediately after 
administration (Figure 1). Single 3-minute intravenous injections of the same doses resulted in 
peak serum levels of 58, 125 and 242mcg/mL. Serum levels of aztreonam 8 hours after 3 or 30 
minute inf
                                
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