AZACTAM 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION VIAL

Active substance: AZTREONAM

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Package leaflet: Information for the patient

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Azactam 1g or 2g
TM

9135A1

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.

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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 interrupt the treatment.
• You have any Liver problems
• You have any Kidney problems
• You are taking a medicine against blood clots (anticoagulants)
• You have any blood disorders, e.g. severe reduction in blood cells which can cause weakness, bruising or make
infections more likely (pancytopenia)
• You have skin disorders, including serious illness with blistering of the skin (toxic epidermal necrolysis)
• You have fits (convulsions or seizures)
Taking Azactam with other medicines
Always tell your doctor or pharmacist about other medicines you may be taking or have recently taken including those
obtained without a prescription. Some medicines can have an effect on each others actions.
Pregnancy and breastfeeding
If you are pregnant or may become pregnant or are breast feeding, you should speak to your doctor before being treated
with Azactam.
Driving and using machinery
Azactam should not affect your ability to drive.
Azactam contains Aztreonam.
3. How you will be given your medicine
Adults:
The adult dose range is 1 to 8g daily. This dose can be split equally over the day meaning you may be given between

PLEASE DETACH BEFORE HANDING ABOVE SECTION TO PATIENT
INFORMATION FOR HEALTH PROFESSIONALS
Below is a summary of the dosage and administration for Azactam. Reference
should be made to the Summary of Product characteristics (SmPC) for full
prescribing information.
ADMINISTRATION:
Intramuscular or intravenous injection, or intravenous infusion.
Adults:
The dose range of Azactam is 1 to 8g daily in equally divided doses. The usual
dose is 3 to 4g daily. The maximum recommended dose is 8g daily. The dosage
and route of administration should be determined by the susceptibility of the
causative organisms, severity of infection, and the condition of the patient.
Type of Infection(1)
Urinary tract infections
Gonorrhoea/cystitis
Cystic Fibrosis
Moderately severe
systemic infections
Severe systemic or lifethreatening infections
Other infections either
or
(1)

Dosage

Frequency (hours)

500 mg or 1 g
1 g
2 g
1 g or 2 g
2g
1g
2 g



Route

8 or 12
single dose
6-8
or 12
8

IM or IV
IM
IV
IM or IV

6 or 8
8
12

IM or IV
IM or IV
IV

Because of the serious nature of infections due to Pseudomonas
aeruginosa, a dose of 2g every 6 or 8 hours is recommended, at least for
initial therapy in systemic infections caused by this organism.
The intravenous route is recommended for patients requiring single doses
greater than 1g, or those with bacterial septicaemia, localised parenchymal
abscess (e.g. intra-abdominal abscess), peritonitis, meningitis or other severe
systemic or life-threatening infections.
Paediatric: The usual dose for patients older than one week is 30mg/kg/dose
every 6 or 8 hours. For severe infections in patients 2 years of age or older,
50mg/kg/dose every 6 or 8 hours is recommended. The recommended dose
for all patients in the treatment of infections due to P. aeruginosa is 50 mg/kg
every six to eight hours. The maximum daily paediatric dose should not exceed
the maximum recommended dose for adults. Dosage information is not yet
available for new-borns less than 1 week old.
Elderly: Renal status is a major determinant of dosage in the elderly; these
patients in particular may have diminished renal function. Serum creatinine
may not be an accurate determinant of renal status. Therefore, as with all
antibiotics eliminated by the kidneys, estimates of creatinine clearance should
be obtained, and appropriate dosage modifications made if necessary.
Elderly patients normally have a creatinine clearance in excess of 30mL/min
and therefore would receive the normal recommended dose. If renal function is
below this level, the dosage schedule should be adjusted (see Renal Impairment).
Renal Impairment: Prolonged serum levels of aztreonam may occur in
patients with transient or persistent renal insufficiency. Therefore, after an
initial usual dose, the dosage of aztreonam should be halved in patients with
estimated creatinine clearances between 10 and 30 mL/min/1.73 m2.
In patients with severe renal failure (creatinine clearance less than
10 mL/min/1.73 m2), such as those supported by hemodialysis, the usual dose
should be given initially. The maintenance dose should be one-fourth of the
usual initial dose given at the usual fixed interval of 6, 8 or 12 hours. For serious

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one to four doses a day. Maximum recommended dose is 8 g per day.
Children:
The usual daily dose in children older than one week is 30mg per kg of body weight given every 6 to 8 hours, but in
severe infections in patients two years of age or older this will be increased to 50mg per kg of body weight.
If you are given more Azactam than you should
It is unlikely that you will receive more Azactam than you should as it will be administered by injection into a muscle or
vein by a doctor, nurse or other suitably trained person. If this does happen you will be closely monitored.
4. Possible side effects
As with all medicines, Azactam can cause unwanted side effects, although not everybody gets them.
Tell your doctor immediately if you get any of the following symptoms:
• swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. These may be signs
of an allergic reaction.
• severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is rare side
effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
Patients treated with Azactam have reported the following side effects:
Uncommon side effects (affects 1 to less than 10 users in 1,000): Temporary increases in the levels of some chemicals
in your blood (creatinine)
Rare side effects (affects 1 to less than 10 users in 10,000): Dizziness, Ringing in the ears, Double vision, Gastrointestinal
bleeding, Diarrhoea with blood or mucous or inflammation, Bad breath, Chest pain, High temperature, Weakness,
Yellowing of the skin, Thrush or other vaginal irritation, Fits, Headache, Wheezing, Breast tenderness, Shortness of
breath, Sneezing, Nasal congestion, Fall in blood pressure, Confusion, Bleeding, Lengthening of the time it takes for a
cut to stop bleeding, Spontaneous bruising, Fall in the number of infection fighting blood cells
Other side effects where the frequencies are unknown include: Abdominal cramps, Mouth ulcers, Nausea and/or
vomiting, Diarrhoea, Altered taste, Discomfort at the injection site, Weakness, Sweating, General aches and pains,
Fever, Temporary increases in the levels of some chemicals in your serum (creatinine), Skin irritation and flaking, Itchy
rash, Flushing, Small red spots, Burning and blistering of the skin
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store your medicine
Keep this medicine out of sight and reach of children.
This medicine will be stored in the pharmacy at not more than 25°C and prepared in a special area before the doctor or
nurse gives it to you. This product is for single use only. The product should not be used after the expiry date shown
on the vial label and on the carton.
6. Further Information
What Azactam contains
The active substance is aztreonam. The other ingredients are: L-arginine (780mg per g of aztreonam).
What Azactam looks like and the contents of the pack
Azactam comes in clear glass vials, closed with siliconed grey butyl rubber closure, sealed with aluminium seal, in
packs of 1 x 15 mL.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
U.K. Ireland


Bristol-Myers Squibb Pharmaceuticals Ltd,
E.R. Squibb & Sons Limited,
Uxbridge Business Park,


Swords, County Dublin
Sanderson Road,



Tel: 1-800-749-749
Uxbridge, Middlesex UB8 1DH
Tel.: 0800 7311736
Manufacturer:
Bristol-Myers Squibb Srl,
Contrada Fontana del Ceraso, 03012 Anagni (Fr), Italy
Date of last revision: June 2013

or life-threatening infections, in addition to the maintenance doses, one-eighth
of the initial dose should be given after each hemodialysis session.
RECONSTITUTION:
Azactam Powder for Solution for Injection or Infusion is supplied in 15mL vials.
Upon the addition of the diluent the contents should be shaken immediately and
vigorously. Vials of reconstituted Azactam are not intended for multi-dose use,
and any unused solution from a single dose must be discarded. Depending on
the type and amount of diluent, the pH ranges from 4.5 to 7.5, and the colour
may vary from colourless to light straw-yellow, which may develop a slight
pink tint on standing; however this does not affect the potency.
For intramuscular injections: For each gram of aztreonam add at least 3mL
Water for Injections Ph Eur or 0.9% Sodium Chloride BP and shake well.
Volume of Diluent to be added
Single-Dose Vial Size
0.5g 1.5mL
1.0g 3.0mL
Azactam is given by deep injection into a large muscle mass, such as the upper
outer quadrant of the gluteus maximus or the lateral part of the thigh.
For intravenous injection: To the contents of the vial add 6 to 10mL of Water
for Injections Ph Eur, and shake well. Slowly inject directly into the vein over
a period of 3 to 5 minutes.
For intravenous infusion: For each gram of aztreonam, add at least 3mL of
Water for Injections Ph Eur and shake well. Dilute this initial solution with an
appropriate infusion solution to a final concentration less than 2% w/v (at least
50mL solution per gram of aztreonam). The infusion should be administered
over 20-60 minutes.
Appropriate infusion solutions include: 0.9% Sodium Chloride Injection
BP 5% Glucose Intravenous Infusion BP, 5% or 10% Mannitol Intravenous
Infusion BP, Sodium Lactate Intravenous Infusion BP, 0.9%, 0.45% or 0.2%
Sodium Chloride & 5% Glucose I.V. Infusion BP, Compound Sodium
Chloride Injection BPC 1959 (Ringer’s Solution for Injection), Compound
Sodium Lactate Intravenous Infusion BP (Hartmann’s Solution for Injection).
A volume control administration set may be used to deliver the initial solution
of Azactam into a compatible infusion solution being administered. With use of
a Y-tube administration set, careful attention should be given to the calculated
volume of Azactam solution required so that the entire dose will be infused.
With intermittent infusion of Azactam and another drug via a common delivery
tube, the tube should be flushed before and after delivery of Azactam with any
appropriate infusion solution compatible with both drug solutions. Except for the
antibiotics described below, the drugs should not be delivered simultaneously.
Reconstitution: Intravenous infusion solution of Azactam for Injection
prepared with 0.9% Sodium Chloride Injection BP or 5% Glucose Intravenous
Infusion BP, in PVC or glass containers, to which clindamycin phosphate,
gentamicin sulphate, tobramycin sulphate, or cephazolin sodium have been
added at concentrations usually used clinically, are stable for up to 24 hours
in a refrigerator (2-8°C). Ampicillin sodium admixtures with aztreonam in
0.9% sodium chloride injection BP are stable for 24 hours in a refrigerator
(2-8°C); stability in 5% Glucose Intravenous Infusion BP is eight hours under
refrigeration. Store the reconstituted solution at 2°C-8°C (under refrigeration)
for not more than 24 hours. Discard any unused solution.
If aztreonam and metronidazole are to be used together, they should be
administered separately as a cherry red colour has been observed after storage
of solutions containing combinations of the two products.
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
Date of last revision: June 2013
9135A1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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