Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
PIPERACILLINE NATRIUM 0-WATER 2,085 g/g SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 2 g/g ; TAZOBACTAM NATRIUM 0,2683 g/g SAMENSTELLING overeenkomend met ; TAZOBACTAM 0,25 g/g
PIPERACILLINE NATRIUM 0-WATER 2,085 g/g SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 2 g/g ; TAZOBACTAM NATRIUM 0,2683 g/g SAMENSTELLING overeenkomend met ; TAZOBACTAM 0,25 g/g
Poeder voor oplossing voor infusie
GEEN HULPSTOFFEN
Intraveneus gebruik
2024-04-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PITAZ 2 G/0,25 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 Pitaz is and what it is used for 2. What you need to know before you use Pitaz 3. How to use Pitaz 4. Possible side effects 5. How to store Pitaz 6. Contents of the pack and other information 1. WHAT PITAZ 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. Pitaz 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. Pitaz may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). Pitaz 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. Pitaz 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 Pitaz in combination with other antibiotics. 2. WHA Les hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Pitaz 2 g/0,25 g poeder voor oplossing voor infusie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g. Excipient with known effect Each vial of Pitaz 2 g/0.25 g contains 108 mg of sodium. 3. PHARMACEUTICAL FORM Powder for solution for infusion White or almost white loose lump or powder The solution for infusion has: • pH 5.0-7.0 • osmolality: 600-700 mOsm/kg (when reconstituted with 10mL WFI) 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pitaz 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. Pitaz 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 Pitaz 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 2 Posology The dose and frequency of Pitaz depends on the severity and localisation of the infection and expected pathogens. Adult and adolescent The usual dose is 4 g piperacillin/0.5 g tazoba Les hele dokumentet