Beipackzettel - Piperacillin/Tazobactam Antibiotice 2 g/0,25 g Pulver zur Herstellung einer Infusionslösung
Zusammenfassung des Risikomanagement-Plans gemäß § 34
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Piperacillin/Tazobactam Atb 2 g/0,25 g Pulver zur Herstellung einer
Infusionslösung
Piperacillin/Tazobactam Atb 4 g/0,5 g Pulver zur Herstellung einer
Infusionslösung
Administrative Information:
| Wirkstoffe | Piperacillin-Natrium Tazobactam-Natrium |
| ATC-Code | J01CR05 |
| Darreichungsform | Pulver zur Herstellung einer Infusionslösung |
| Art der Anwendung | intravenöse Anwendung |
| Inhaber der Zulassung | Antibiotice SA Str. Valea Lupului nr. 1 707410 IASI Rumänien |
| Zulassungsnummern | 7007903.00.00 7007904.00.00 |
| Datum der Zulassung | 10.05.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 1.3 / 17.04.2024 |
| Datum der Genehmigung des RMPs | 10.05.2024 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) der o. g. Arzneimittel ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass diese Arzneimittel so sicher wie möglich angewendet werden.
Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).
Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimitteln gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 28. Juni 2024 veröffentlicht.
-
(1)
-
(2)
Part VI: Summary of the risk management plan for Perasin 2 g/0.25 g and Perasin 4
g/0.5 g powder for solution for infusion
This is a summary of the risk management plan (RMP) for piperacillin/tazobactam. The RMP details important risks of piperacillin/tazobactam how these risks can be minimised, and uncertainties (missing information).
Perasin powder for solution for infusion summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how the drugs should be used.
Important new concerns or changes to the current ones will be included in updates of Perasin
powder for solution for infusion’s RMP.
-
I. The medicine and what it is used for
Perasin powder for solution for infusion are authorised for the treatment of the following infections in adults and children over 2 years of age:
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.
Perasin 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
Perasin 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.
It contains piperacillin/tazobactam as the active substance and it is given by intravenous infusion.
-
II. Risks asssociated with the medicine and activities to minimise or further characterise the risks
Important risks of piperacillin/tazobactam, together with measures to minimise such risks, are outlined below.
Measures to minimise the risks identified are:
Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and heathcare professionals;
Important advice on the medicine’s packaging;
The authorized pack size the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly
The medicine’s legal status- Prescription only product.
Together, these measures constitute routine risk minimisation measures.
No additional risk minimisation measures are proposed.
In addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
No additional risk minimisation measures are proposed.
-
II. A. List of important risks and missing information
Important risks of piperacillin/tazobactam are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of piperacillin/tazobactam. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected.
| Summary of safety concerns | |
| Important identified risks | None |
| Important potential risks | None |
| Missing information | None |
-
II. B. Summary of important risks
The safety information in the Product Information for Perasin powder for solution for infusion is aligned to the reference medicinal product Tazocin powder for solution for infusion.
-
II. C. Post- authorisation development plan
-
II. C.1 Studies which are conditions of the marketing authorisation
Not applicable.
-
II. C.2 Other studies in post-authorisation development plan Not applicable.