1 g and 2 g powder for injection and infusion solution 
aztreonam

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Azactam is and what it is used for 
2. What you need to know before you use Azactam 
3. How to use Azactam 
4. Possible side effects 
5. How to store Azactam 
6. Contents of the packaging and other information 

1. What Azactam is and what it is used for

Azactam is an antibiotic belonging to the group of beta-lactams. Azactam is used to treat severe infections caused by gram-negative bacteria (eg pneumonia, urinary tract infections, and urogenital infections ). 

Aztreonam contained in Azactam may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Azactam

Do not use Azactam

  • if you are allergic to aztreonam or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before using Azactam:

  • if you are allergic to certain antibiotics such as penicillin or cephalosporins.
  • if you have impaired liver or kidney function, transient or persistent kidney failure. Liver and kidney function should be checked by taking regular blood tests.

Talk to your doctor if you experience any of the following after starting treatment with Azactam:

  • if you get symptoms of severe changes in blood levels.
  • if you get severe skin changes.
  • if you have seizures.
  • if you have diarrhea. This can be diarrhea associated with Clostridium difficile(CDAD) and has been reported with the use of almost all antibiotics, including aztreonam. CDAD can vary in severity from mild diarrhea to fatal colitis and must be considered in all patients who develop diarrhea after using antibiotics. It is important to follow this as CDAD has been reported to occur several weeks after treatment with antibiotics .

The use of antibiotics can promote the growth of resistant microorganisms, including certain bacteria and fungi.

Children

There are limited data on safety and efficacy in newborns younger than one week. Use in this group must be carefully evaluated.

Other medicines and Azactam

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If an aminoglycoside is used concurrently as aztreonam, renal function should be monitored because the antibiotics of the type aminoglycoside can damage the kidneys and the inner ear.

When Azactam is used at the same time as other medicines, it may be necessary to adjust the dose of Azactam. It is especially important to consult your doctor if you use the following:

  • drugs that increase the excretion of uric acid (eg probenecid)
  • drugs that promote the excretion of urine (eg furosemide )
  • medicines that prevent the blood from clotting (eg oral anticoagulants )
  • other antibiotics (eg aminoglycosides, cefoxitin, and imipenem).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is little experience with the use of Azactam during pregnancy. Aztreonam passes through the placenta and enters the fetal bloodstream. Azactam passes into breast milk.

Driving and using machines

No studies on the ability to drive and use machines have been performed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Azactam contains arginine

Studies in children with low birth weight have shown that the amino acid arginine contained in this medicine can increase the amount of arginine, insulin, and bilirubin in the blood. The consequences of exposure to arginine during the treatment of newborns have not been fully established.

3. How to use Azactam

This medicine will be given in a hospital by a healthcare professional.

The recommended dose for adult patients is 1 g or 2 g every 8 to 12 hours. Sometimes the doctor may prescribe a lower or higher dose to adjust the dose one after infection one. In some infections, Azactam is combined with other antibiotics.

The maximum recommended dose is 8 g per day.

Use for children

The recommended dose for patients older than one week is 30 mg/kg every 6 or 8 hours. Your doctor may prescribe a lower or higher dose depending on the infection.

The maximum daily dose for children must not exceed the maximum recommended dose for adults.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following serious side effects, contact your doctor or nurse immediately:

  • swelling of the face, lips, mouth, tongue, or throat [has been reported (affects an unknown number of users)]
  • skin reactions (eg redness, scaling, red spots, blisters) [has been reported (occurs in an unknown number of users)]
  • allergic reactions [reported (occurs in an unknown number of users)].

Other side effects ar

Uncommon (may affect up to 1 in 100 people):

  • increased tendency to bleed, elevated renal values.

Rare (may affect up to 1 in 1,000 people):

  • heart rhythm changes
  • altered blood levels (shown at blood tests)
  • anemia
  • cramps
  • knitting
  • dizziness
  • headache
  • double vision
  • instability
  • öronsus
  • difficulty breathing (wheezing, shortness of breath)
  • sneezing
  • stuffy nose
  • colitis, bleeding in the gastrointestinal tract
  • bad breath
  • muscle pain
  • gynecological infection (vaginitis)
  • low blood pressure
  • bleeding
  • chest pain
  • fever
  • impotence
  • feeling sick
  • hepatitis ( inflammation of the liver)
  • yellowing of the skin and eyes
  • sore breasts
  • confusion
  • insomnia.

Has been reported (occurs in an unknown number of users):

  • taste changes
  • respiratory cramps
  • abdominal pain
  • cold sores
  • nausea
  • vomiting
  • diarrhea
  • infection of the skin
  • rash
  • itching
  • extreme sweating
  • inflammation of veins
  • discomfort at the injection site
  • elevated liver values ​​(shown during a blood test).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Azactam

Keep this medicine out of the sight and reach of children. 

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month. 

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aztreonam. 
  • The other ingredient is L- arginine.

What the medicine looks like and the contents of the pack

Azactam is a white powder that gives a colorless or light yellow solution, depending on the diluent and concentration.

The pack contains one vial of 1 g or 2 g of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Bristol-Myers Squibb AB

Manufacturer

Swords Laboratories T / A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

CATALENT ANAGNI SRL

Loc. Fontana del Ceraso snc

Provincial Street 12 Casilina, 41

03012 ANAGNI (FR)

Italy

Muhammad Nadeem

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