Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
ceftolozane sulfate, tazobactam sodium
Merck Sharp & Dohme B.V.
J01
ceftolozane, tazobactam
Antibacterials for systemic use,
Bacterial Infections
Zerbaxa is indicated for the treatment of the following infections in adults:Complicated intra abdominal infections;Acute pyelonephritis;Complicated urinary tract infections;Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Revision: 15
Authorised
2015-09-18
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZERBAXA 1 G / 0.5 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION ceftolozane / tazobactam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If y ou get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Se e section 4. WHAT IS IN THIS LEAFLET 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 1. WHAT ZERBAXA IS AND WHAT IT IS USED FOR Zerbaxa is a medicine used to treat a range of bacterial infections. It contains two active substances: - ceftolozane, an antibiotic that belongs to the group of “cephalosporins” and which can kill certain bacteria that can cause infection; - tazobactam, which blocks the action of certain enzymes called beta - lactamases. These enzymes make bacteria resistant to ceftolozane by breaking down the antibiotic before it can act. By blocking their action, tazobactam makes ceftolozane more effective at killing bacteria. Zerbaxa is used in all age groups to treat complicated infections within the a bdomen, and kidney and urinary system . Zerbaxa is also used in adults to treat an infection of the lungs called “pneumonia” . 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZERBAXA DO NOT TAKE ZERBAXA - 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 “ cephalosporin s” . - if you have had a severe allergic reaction (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue or throat; or diffi culty swallowing or breathing) to certain other antibiotics (e.g., penicillins Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam. After reconstitution with 10 mL diluent, the total volume of the solution in the vial is 11.4 mL, which contains 88 mg/mL of ceftolozane and 44 mg/mL of tazobactam. Excipient with known effect E ach vial contains 10 mmol (230 mg) of sodium. When the powder is reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, the vial contains 11.5 mmol (265 mg) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). White to yellow ish powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zerbaxa is indicated for the treatment of the following infections in adult and paediatric patients (see sections 4.2 and 5.1): - Complicated intra - abdominal infections (see section 4.4); - Acute pyelonephritis; - Complicated urinary tract infections (see section 4.4). Zerbaxa is also indicated for the treatment of the following infection in adult patients (18 years or older) (see section 5.1): - Hospital- acquired pneumonia (HAP), including ventilator - associated pneumonia (VAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended intravenous dose regimen for adult patients with creatinine clearance > 50 mL/min is shown by infection type in Table 1. 3 TABLE 1: INTRAVENOUS DOSE OF ZERBAXA BY TYPE OF INFECTION IN ADULT PATIENTS (18 YEARS OR OLDER) WITH CREATININE CLEARANCE * > 50 ML/MIN TYPE OF INFECTION DOSE FREQUENCY INFUSION TIME DURATION OF TREATMENT Complicated intra -abdominal infection** 1 g ceftolozane / 0.5 g tazobactam Every 8 hours 1 hour 4-14 days Complicated urinary tract Przeczytaj cały dokument