Azactam 2g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aztreonam

Available from:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC code:

J01DF01

INN (International Name):

Aztreonam

Dosage:

2gram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010203; GTIN: 5012712001119

Patient Information leaflet

________________________________________________________________________
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
•
You are pregnant or planning to become pregnant
YOU MUST TELL YOUR DOCTOR 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
severe or prolonged or bloody diarrhoea during or after using Azactam
tell your
doctor as soon as possible since it may be necessary to

Summary of Product characteristics

OBJECT 1
AZACTAM 1G POWDER FOR SOLUTION FOR INJECTION OR
INFUSION, VIAL
Summary of Product Characteristics Updated 22-Nov-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
Azactam 1 g Powder for Solution for Injection or Infusion
Azactam 2 g Powder for Solution for Injection or Infusion
2. Qualitative and quantitative composition
Each vial contains 1 g aztreonam.
Each vial contains 2 g aztreonam.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion.
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 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.
Bacteriologic