Below is a text only representation of the Patient Information Leaflet (ePIL).
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The product code(s) for this leaflet is: PL 12038/0002.
Azactam 1g or 2g Powder for Solution for Injection or Infusion, vial
Package leaflet: Information for the patient
AzactamTM 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
Warnings and precautions
Talk to your doctor before taking 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 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)
Positive results in a Coombs’ test (a test for some blood problems)
You have fits (convulsions or seizures)
You are taking an antibiotic or oral anticoagulants
You must tell your doctor if you experience encephalopathy (unexplained confusion, altered mental function, coma, seizure, or weakness).
Taking Azactam with other medicines
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.
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
This medicine could affect your ability to drive and use machinery should encephalopathy occur (see section 2 and 4).
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 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.
Kidney and liver problems
If you have kidney or liver problems, you may receive a lower dose than usual.
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.
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.
4. Possible side effects
Like 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 (may affect up to 1 in 100 people)
Increased levels of some chemicals in your blood (creatinine)
Rare side effects (may affect up to 1 in 1000 people)):
Dizziness
Ringing in the ears
Double vision
Bleeding of the stomach
Painful or swollen colon
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
Tingling/numbness
Difficulty sleeping
Blocked nose
Change in heart beat
Fall in blood pressure
Confusion
Bleeding
Lengthening of the time it takes for a cut to stop bleeding
Spontaneous bruising
convulsion
Muscle pain
Painful or swollen liver
Feeling of general discomfort
Increase or decrease in the number of blood clotting cells
Increase or decrease in the number of white blood cells
Fall in the number of red blood cells
A false positive test for antibodies (Coombs test)
Other side effects where the frequencies are unknown include:
Abdominal cramps
Mouth ulcers
Feeling and/or being sick
Looser and/or more frequent stools
Altered taste
Discomfort at the injection site
Weakness
Sweating
General aches and pains
Fever
Changes in the levels of some chemicals in your blood serum (creatinine, transaminase, alkaline phosphatase)
Skin irritation and flaking
Itchy rash
Flushing
Small red spots
Burning and blistering of the skin
Hives
Encephalopathy (confusion, altered mental function, coma, seizure, or weakness)
Serious life threatening allergic reaction
Difficulty breathing due to muscle spasms in the lung
Swelling of the skin
excessive bruising of the skin
Rash
swelling of the veins in the legs which may be related to a blood clot
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 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.
6. Contents of the pack and other information
What Azactam contains
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).
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 with plastic flip off button, in packs of 1 x 15 mL.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bristol-Myers Squibb Pharmaceuticals Unlimited Company Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 Dublin D15 T867
Manufacturer:
CATALENT ANAGNI S.R.L. Loc. Fontana del Ceraso snc Strada Provinciale 12 Casilina, 41 03012 ANAGNI (FR) Italy
Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland
Date of last revision: January 2023
Bristol Myers Squibb Pharmaceuticals limited
Address
Bristol-Myers Squibb, ARC Uxbridge, Sanderson Road, New Denham, Denham, Buckinghamshire, UB8 1DH, UK