The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12038/0002.
Azactam 1g or 2g Powder for Solution for Injection or Infusion, vial
AzactamTM 1g or 2g
Powder for Solution for Injection or Infusion
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.
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
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.
Talk to your doctor before taking Azactam if
You must tell your doctor if you experience encephalopathy (unexplained confusion, altered mental function, coma, seizure, or weakness).
Always tell your doctor or pharmacist about other medicines you are taking, have recently taken or may take including those obtained without a prescription. Some medicines can have an effect on each other’s actions.
If you are pregnant or may become pregnant or are breast feeding, you should speak to your doctor before being treated with Azactam.
This medicine could affect your ability to drive and use machinery should encephalopathy occur (see section 2 and 4).
Azactam contains Aztreonam.
The adult dose range is 1 to 8g daily. This dose can be split equally over the day meaning you may be given between one to four doses a day. Maximum recommended dose is 8 g per day.
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 have kidney or liver problems, you may receive a lower dose than usual.
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.
You must tell your doctor if you experience unexplained confusion, altered mental function, coma, seizure, or weakness..
If you have any further questions on the use of this medicine, ask your doctor.
Like all medicines, Azactam can cause unwanted side effects, although not everybody gets them.
Patients treated with Azactam have reported the following side effects:
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)):
Other side effects where the frequencies are unknown include:
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.
Keep this medicine out of the 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.
The active substance is aztreonam. The other ingredients are: L-arginine (780 mg per g of aztreonam or 1.54 g per 2 g of aztreonam).
Azactam comes in clear glass vials, closed with siliconed grey butyl rubber closure, sealed with aluminium seal with plastic flip off button, in packs of 1 x 15 mL.
Marketing Authorisation Holder
Date of last revision: January 2023