Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Zerbaxa is and what it is used for
2. What you need to know before you take Zerbaxa
3. How to take Zerbaxa
4. Possible side effects
5. How to store Zerbaxa
6. Contents of the pack and other information

• if you are allergic to ceftolozane, tazobactam or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines known as “cephalosporins”.
• if you have had a severe allergic reaction (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue or throat; or difficulty swallowing or breathing) to certain other antibiotics (e.g., penicillins or carbapenems).

Talk to your doctor or pharmacist before taking Zerbaxa if you know you are, or have previously been allergic to cephalosporins, penicillins or other antibiotics.

Talk to your doctor or pharmacist if you develop diarrhoea while taking Zerbaxa.

Infections caused by bacteria that are not sensitive to Zerbaxa or caused by a fungus can occur during or following treatment with Zerbaxa. Tell your doctor if you think you may have another infection.

Treatment with Zerbaxa sometimes causes production of antibodies that react with your red blood cells. If you are told that you have an abnormal blood test (called Coombs test) tell your doctor that you are having or have recently had Zerbaxa.

This medicine should not be given to children under 18 years old to treat pneumonia because there is not enough information on use in this age group for the treatment of this infection.

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

Some medicines may interact with ceftolozane and tazobactam. These include:

• Probenecid (a medicine for gout). This can increase the time it takes for tazobactam to leave your body.

If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will advise if you should receive Zerbaxa during pregnancy.

If you are breast-feeding, your doctor will advise you on whether you should stop breast-feeding or stop or avoid Zerbaxa therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.

Zerbaxa may cause dizziness, which can affect your ability to drive and use machines.

This medicine contains 230 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 11.5% of the recommended maximum daily dietary intake of sodium for an adult. The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium in each vial. This is equivalent to 13.3% of the recommended maximum daily dietary intake of sodium for an adult.

The recommended dose of Zerbaxa is 1 g of ceftolozane and 0.5 g of tazobactam or 2 g of ceftolozane and 1 g of tazobactam every 8 hours, which is given into one of your veins (directly into the bloodstream).

Treatment with Zerbaxa normally lasts between 4 and 14 days, depending on the severity and location of the infection and on how your body responds to the treatment.

The recommended dose of Zerbaxa is 20 mg/kg of ceftolozane and 10 mg/kg of tazobactam every 8 hours, which is given into one of your veins (directly into the bloodstream). The dose should not exceed 1 g of ceftolozane and 0.5 g of tazobactam.

Treatment with Zerbaxa normally lasts between 5 and 14 days, depending on the severity and location of the infection and on how your body responds to the treatment.

Your doctor may need to reduce the dose of Zerbaxa or decide how often Zerbaxa is given to you. Your doctor may also want to test your blood to make sure you receive an appropriate dose, especially if you have to take this medicine for a long time.

As this product is given by a doctor or other healthcare professional, it is very unlikely that you will be given too much Zerbaxa. However, if you have any concerns you should let your doctor, nurse or pharmacist know immediately.

If you think you have not been given a dose of Zerbaxa, tell your doctor or other healthcare professional immediately.

• Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening
• Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zerbaxa. In this situation, you should not take medicines that stop or slow bowel movement

Adults treated for complicated infections within the abdomen, and kidney and urinary system

Common side effects (may affect up to 1 in 10 people):

Headache, stomach ache, constipation, diarrhoea, nausea, vomiting, increase in liver enzymes (from blood tests), rash, fever (high temperature), decrease in blood pressure, decrease in potassium (from blood tests), increase in the number of certain types of blood cells known as platelets, dizziness, anxiety, difficulty sleeping, infusion site reactions

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

Inflammation of the large intestine due to C. difficile bacteria, inflammation of the stomach, abdominal distension, indigestion, excessive gas in stomach or bowel, obstruction of the intestine, yeast infection in the mouth (thrush), yeast infection of female genitalia, fungal urinary tract infection, increase in sugar (glucose) levels (from blood tests), decrease in magnesium levels (from blood tests), decrease in phosphate levels (from blood tests), ischemic stroke (stroke caused by reduced blood flow in brain), irritation or inflammation of a vein at injection site, venous thrombosis (blood clot in a vein), low red blood cell counts, atrial fibrillation (rapid or irregular heartbeat), fast heartbeat, angina pectoris (chest pain or feeling of tightness, pressure or heaviness in chest), itchy rash or swellings on the skin, hives, Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells), kidney problems, kidney disease, shortness of breath

Additional side effects observed in children and adolescents treated for complicated infections within the abdomen, and kidney and urinary system

Common side effects (may affect up to 1 in 10 people):

Increased appetite, low white blood cell counts, altered taste

Adults treated for an infection of the lungs called “pneumonia”

Common side effects (may affect up to 1 in 10 people):

Inflammation of the large intestine due to C. difficile bacteria, diarrhoea, vomiting, increase in liver enzymes (from blood tests)

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

Infection due to C. difficile bacteria, C. difficile test positive (from stool test), Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells)

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substances are ceftolozane and tazobactam.
• Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam. For doses above 1 g ceftolozane and 0.5 g tazobactam, two vials are used.
• The other excipients are sodium chloride, arginine, and citric acid, anhydrous.

Zerbaxa is a white to slightly yellow powder for concentrate for solution for infusion (powder for concentrate) supplied in a vial.

Zerbaxa is available in packs containing 20 mL Type I clear glass vial with stopper (bromobutyl rubber) and flip-off seal.

Pack size of 10 vials.

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