Maa: Alankomaat
Kieli: hollanti
Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PIPERACILLINE NATRIUM 0-WATER 4,17 g/flacon SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 4 g/flacon ; TAZOBACTAM NATRIUM 547,3 mg/flacon SAMENSTELLING overeenkomend met ; TAZOBACTAM 500 mg/flacon
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J01CR05
PIPERACILLINE NATRIUM 0-WATER 4,17 g/flacon SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 4 g/flacon ; TAZOBACTAM NATRIUM 547,3 mg/flacon SAMENSTELLING overeenkomend met ; TAZOBACTAM 500 mg/flacon
Poeder voor oplossing voor injectie of infusie
GEEN HULPSTOFFEN,
Intraveneus gebruik
Piperacillin and beta-lactamase inhibitor
Hulpstoffen: GEEN HULPSTOFFEN;
1900-01-01
Sandoz B.V. Page 1 Piperacilline/Tazobactam 4 g/0,5 g RVG 34088 V9 1.3.1.3 Bijsluiter April 2022 BIJSLUITER: INFORMATIE VOOR DE PATIËNT PIPERACILLINE/TAZOBACTAM 4 G/0,5 G, POEDER VOOR OPLOSSING VOOR INFUSIE piperacillin / tazobactam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [nationally completed name] is and what it is used for 2. What you need to know before you use [nationally completed name] 3. How to use [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] 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. [nationally completed name] 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. [nationally completed name] may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). [nationally completed name] 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 a Lue koko asiakirja
Sandoz B.V. Page 1 Piperacilline/Tazobactam 4 g/0,5 g RVG 34088 1311-V13B 1.3.1.1. Samenvatting van de Productkenmerken Mei 2023 1. NAAM VAN HET GENEESMIDDEL Piperacilline/Tazobactam 4 g/0,5 g, poeder voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial or bottle contains 4 g piperacillin (as piperacillin sodium) and 0.5 g tazobactam (as tazobactam sodium). Excipients with known effect Each vial or bottle contains 9.44 mmol (217 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 [nationally completed name] 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. [nationally completed name] may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. Note: Use for bacteraemia due to extended-beta-lactamase (ESBL) producing E. coli and K. pneumoniae (ceftriaxone non-susceptible), is not recommended in adult patients, see section 5.1. CHILDREN 2 TO 12 YEARS OF AGE - Complicated intra-abdominal infections Sandoz B.V. Page 2 Piperacilline/Tazobactam 4 g/0,5 g RVG 34088 1311-V13B 1.3.1.1. Samenvatting van de Productkenmerken Mei 2023 [nationally completed name] 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 METHO Lue koko asiakirja