Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
CEFTOLOZANE AS SULFATE; TAZOBACTAM AS SODIUM
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
J01DI54
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
TAZOBACTAM AS SODIUM 0.5 G; CEFTOLOZANE AS SULFATE 1 G
I.V
Required
MERCK SHARP & DOHME LLC, USA
CEFTOLOZANE AND ENZYME INHIBITOR
Zerbaxa is indicated for the treatment of the following infections in adults:-Complicated intra abdominal infections;-Acute pyelonephritis caused by pathogens resistant to other treatments as confirmed by urine culture-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
2023-01-31
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician’s prescription only ZERBAXA ® 1 g/0.5 g Powder for Concentrate for Solution for Infusion Each vial contains: Ceftolozane (as sulfate) 1 g Tazobactam (as sodium) 0.5 g For doses above 1 g ceftolozane and 0.5 g tazobactam, two vials are used. For a list of inactive ingredients see section 6. “FURTHER INFORMATION”. See also section 2.7 “Important information about some of the ingredients of ZERBAXA”. Read the entire leaflet carefully before you start using this medicine. • This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or the pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. 1. WHAT ZERBAXA IS INTENDED FOR? ZERBAXA is used in adults to treat complicated infections within the abdomen, kidney and urinary system infections, and Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). Therapeutic group: Antibacterials for systemic use, other cephalosporins and penems. ZERBAXA 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. 2. BEFORE USING ZERBAXA 2.1 Do not use ZERBAXA if: - you are sensitive (allergic) to ceftolozane, tazobactam or any of the other ingredients of this medicine (For a list of inactive ingredients, see section 6). - you are allergic to medicines known as “cephalosporins”. - you have had a severe allergic reaction (e.g., severe skin peeling; swelling of th Pročitajte cijeli dokument
1 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 Each 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 yellowish powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zerbaxa is indicated for the treatment of the following infections in adults (see section 5.1): - Complicated intra-abdominal infections (see section 4.4); - Acute pyelonephritis caused by pathogens resistant to other treatments as confirmed by urine culture; - Complicated urinary tract infections (see section 4.4). - 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 patients with creatinine clearance > 50 mL/min is shown by infection type in Table 1. 2 Table 1: Intravenous dose of Zerbaxa by type of infection in patients 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 infection Acute pyelonephritis 1 g ceftolozane / 0.5 g tazobactam Every 8 hours 1 hour 7 days Hospital-acquired pneumonia, including ventilator-associated pneumonia Pročitajte cijeli dokument