Azactam 1g and 2g Powder for Solution for Injection or Infusion

Package leaflet: Information for the patient

AzactamÔ 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:

What Azactam is and what it is used for
What you need to know before you are given your medicine
How you will be given your medicine
Possible side effects
How to store your medicine
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 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 or are using a certain antibiotics (aminoglycosides)
• You are taking a medicine for 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)
• You develop any bacterial or fungal infections
• You test positive in a Coombs’ test (a test for some blood problems)

You must tell your doctor if you experience unexplained confusion, altered mental function, coma, seizure, or weakness.

Other medicine and Azactam

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 other’s actions.

Pregnancy and breastfeeding

If you are pregnant or may become pregnant, you should speak to your doctor before being treated with Azactam. Breast-feeding is not recommended while taking Azactam. Tell your doctor if you are breast-feeding.

Driving and using machinery

This medicine could affect your ability to drive or use machinery (see sections 2 and 4). Azactam has also been shown to cause dizziness, confusion, and blurred vision (please see Section 4 below).

Azactam contains aztreonam.

3. How you will be given your medicine

Azactam will be given to you under the supervision of an experienced doctor.

How it will be given, either as an infusion (a drip) and/or into a vein (intravenously) will be determined by your doctor.

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 30 mg 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 50 mg per kg of body weight every 6 to 8 hours. The maximum daily dose in children should not exceed the maximum recommended dose for adults.

Elderly:

Kidney function is a major determinant of the dose of Azactam given to the elderly. The doctor will assess kidney function by measuring a chemical called creatinine in the blood and also in the urine. If this level is above a certain limit (30 mL/min), the normal recommended adult dose will be given. However, if this level is below the limit (30 mL/min), the dose will be adjusted accordingly by the doctor.

Liver and Kindney

The dose of Azactam given will also be adjusted by the doctor for anyone with severe kidney disease, for example kidney failure.

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 of this medicines, 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: may affect less than 1 in 10 people

• Temporary increases in the levels of some chemicals in your blood (creatinine)

Rare: may affect up to 1 in 1000 people 

• Pins and needles
• Inflammation of the liver
• Spinning sensation
• Muscle pain
• Changes to blood count
• Positive results in a Coombs’ test (a test for some blood problems)
• Difficulty sleeping
• Changes in your heart beat (measured by electrocardiogram-ECG)
• Feeling of being unwell
• Dizziness
• Ringing in the ears
• Double vision
• Gastrointestinal bleeding
• Diarrhoea with blood or mucous or inflammation
• Bad breath
• Chest pain
• Fever
• 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
• Decrease in blood cells
• Increase or decrease in the number of infection fighting blood cells

Not known: frequency cannot be estimated from available data:

• Narrowing of the airways in the lungs
• Inflammation of the veins
• Tender or painful veins
• Increase in some liver enzymes
• Increase in blood alkaline phosphatise (certain substance in the blood)
• Sweating
• Excessive sweating
• Swelling of eyes, lips and throat
• Abdominal cramps
• Mouth ulcers
• Nausea and/or vomiting
• Diarrhoea
• Altered taste
• Discomfort at the injection site
• Weakness
• Severe allergic reaction
• Skin conditions including
• Serious skin rashes
• Swelling of the skin that resembles severe burns
• Inflammation and peeling of the skin
• Rash
• Itching
• Red or purple discolouration of the skin
• Pin point bleeding under the skin
• Confusion, altered mental function, coma, seizure, or weakness

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:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL-Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

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. Do not use this medicines after the expiry date which is stated on the vial label and on the carton. The expiry date refres to the last day of that month.

6. Further Information

What Azactam contains

The active substance is aztreonam. Each vial contains either 1g or 2g 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 a plastic flip off button, in packs of 1 x 15 mL.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bristol-Myers Squibb Pharmaceuticals uc

Plaza 254

Blanchardstown Corporate Park 2

Ballycoolin

Dublin 15

D15 T867

Ireland

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: October 2022