Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Piperacillin; Tazobactam
Rowex Ltd
J01CR; J01CR05
Piperacillin; Tazobactam
2g / 0.25 gram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; piperacillin and enzyme inhibitor
Not marketed
2008-10-10
1 WHAT PIPERIN IS AND WHAT IT IS USED FOR Piperacillin belongs to the group of medicines known as “broad-spectrum penicillin antibiotics”. It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed. Piperin is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperin may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). Piperin is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperin may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). In certain serious infections, your doctor may consider using Piperin in combination with other antibiotics. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE PIPERIN DO NOT USE PIPERIN • if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6). • if you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperin. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Piperin • if you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product. • if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor. • if you have low levels of pota Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 08 July 2021 CRN009ZZ2 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piperin 2 g/0.25g Powder for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2 g piperacillin (as piperacillin sodium) and 0.25 g tazobactam (as tazobactam sodium). Excipients with known effect Each vial contains 4.72 mmol (109 mg) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. A white to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piperin is indicated for the treatment of the following infections in adults and children over 2 years of age (see sections 4.2 and 5.1): ADULTS AND ADOLESCENTS - Severe pneumonia including hospital-acquired and ventilator-associated pneumonia - Complicated urinary tract infections (including pyelonephritis) - Complicated intra-abdominal infections - Complicated skin and soft tissue infections (including diabetic foot infections) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Piperin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. CHILDREN 2 TO 12 YEARS OF AGE - Complicated intra-abdominal infections Piperin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose and frequency of Piperin depends on the severity and localisation of the infection and expected pathogens. _Adult and adolescent patients_ _Infections _ The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8 hours. Health Products Regulatory Authority 08 July 2021 CRN009ZZ2 Page 2 of 13 For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose Olvassa el a teljes dokumentumot