Azactam 2 g Powder for Solution for Injection or Infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Aztreonam

Dostopno od:

Bristol-Myers Squibb Pharmaceuticals uc

Koda artikla:

J01DF; J01DF01

INN (mednarodno ime):

Aztreonam

Odmerek:

2 gram(s)

Farmacevtska oblika:

Powder for solution for injection/infusion

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Monobactams; aztreonam

Status dovoljenje:

Marketed

Datum dovoljenje:

1985-03-05

Navodilo za uporabo

________________________________________________________________________
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZACTAM
 1G OR 2G
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
AZTREONAM
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
PLEASE KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
-
IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR.
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. DO NOT PASS IT ON TO
OTHERS. IT
MAY HARM THEM, EVEN IF THEIR SIGNS OF ILLNESS ARE THE SAME AS YOURS.
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST. THIS
INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
WHAT IS IN THIS LEAFLET:
1.
What Azactam is and what it is used for
2.
What you need to know before you are given your medicine
3.
How you will be given your medicine
4.
Possible side effects
5.
How to store your medicine
6.
Contents of the pack and other information
1.
WHAT AZACTAM IS AND WHAT IT IS USED FOR
The name of this medicine is Azactam. The active ingredient in Azactam
is aztreonam.
Azactam is available in two strengths and each vial contains either 1g
or 2g aztreonam as
a powder for solution for injection or infusion. Aztreonam is an
antibiotic and a member
of the family of medicines called monobactams. Azactam also contains
L-arginine.
Azactam is for the treatment of serious infections caused by bacteria
which require an
antibiotic injection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN YOUR MEDICINE
DO NOT TAKE AZACTAM IF:

You are allergic to aztreonam or L-arginine or any of the ingredients
of this
medicine (listed in Section 6)

You are pregnant or planning to become pregnant
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Azactam.
TAKE SPECIAL CARE WITH AZACTAM IF

You have ever had an allergic reaction to any antibiotics

You have diarrhoea or usually get diarrhoea when you take antibiotics
or have
ever suffered from problems with your stomach or intestines. If you
develop

Lastnosti izdelka

Health Products Regulatory Authority
01 December 2022
CRN00D7QD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Azactam 2 g Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2g aztreonam.
Excipients with known effect
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
A sterile white to off-white, sodium-free powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of the following infections caused by susceptible
aerobic Gram-negative micro-organisms:
Urinary tract infections: Including pyelonephritis and cystitis
(initial and recurrent) and asymptomatic bacteriuria, including
those due to pathogens resistant to the aminoglycosides,
cephalosporins or penicillins.
Gonorrhoea: Acute uncomplicated urogenital or anorectal infections
including infections due to beta-lactamase producing or
non-producing strains of _N. gonorrhoeae_.
Lower respiratory tract infections: Including pneumonia, bronchitis
and lung infections in patients with cystic fibrosis.
Bacteraemia / septicaemia.
Meningitis caused by _Haemophilus influenzae_ or _Neisseria
meningitidis_. Since Azactam provides only Gram negative cover, it
should not be given alone as initial blind therapy, but may be used
with an antibiotic active against Gram positive organisms
until the results of sensitivity tests are known.
Bone and joint infections.
Skin and soft tissue infections: Including those associated with
postoperative wounds, ulcers and burns.
Intra-abdominal infections: Peritonitis.
Gynaecological infections: Pelvic inflammatory disease, endometritis,
and pelvic cellulitis.
Azactam is indicated for adjunctive therapy to surgery in the
management of infections caused by susceptible organisms,
including abscesses, infections complicating hollow viscus
perforations, cutaneous infections and infections of serous surfaces.
Bacteriological studies to determine the causative organism(s) and
their