Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Furosemid Basi 10 mg/ml Injektions-/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)
Furosemid Basi 10 mg/ml Injektions-/Infusionslösung
Administrative Information:
| Wirkstoff | Furosemid |
| ATC-Code | C03CA01 |
| Darreichungsform | Injektions-/Infusionslösung |
| Art der Anwendung | intramuskuläre Anwendungintravenöse Anwendung |
| Inhaber der Zulassung | Laboratórios Basi – Indústria Farmaceutica, S.A. Parque Industrial Manuel Lourenco Ferreira, lote 15 3450–232 MORTAGUA Portugal |
| Zulassungsnummer | 7006665.00.00 |
| Datum der Zulassung | 12.01.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.2 / 04.01.2023 |
| Datum der Genehmigung des RMPs | 12.01.2024 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels 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 dieses Arzneimittel so sicher wie möglich angewendet wird.
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. Arzneimittel 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. Februar 2024 veröffentlicht.
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HUH
RISK MANAGEMENT PLAN
Código / Code : MOD.888
Revisão / Revision : 1
Summary of risk management plan for Furosemide Basi 10 mg/ml, solution for injection or infusion (Furosemide)
This is a summary of the risk management plan (RMP) for Furosemide Basi 10 mg/ml, solution for injection or infusion. The RMP details important risks of Furosemide Basi 10 mg/ml, solution for injection or infusion , how these risks can be minimised and how more information will be obtained about Furosemide Basi 10 mg/ml, solution for injection or infusion risks and uncertainties (missing information).
Furosemide Basi 10 mg/ml, solution for injection or infusion summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Furosemide Basi 10 mg/ml, solution for injection or infusion should be used.
Important new concerns or changes to the current ones will be included in updates of Furosemide Basi 10 mg/ml, solution for injection or infusion ’s RMP.
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I. The medicine and what it is used for
Furosemide Basi 10 mg/ml, solution for injection or infusion is used when no adequate diuresis is achieved with oral administration of furosemide or when oral use is not possible: oedemas and/or ascites secondary to cardiac or hepatic disorders; oedemas secondary to renal disorders; pulmonary oedema; hypertensive crisis (see SmPC for the full indication). It contains furosemide as the active substance and it is given by intravenous or intramuscular route.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Furosemide Basi 10 mg/ml, solution for injection or infusion , together with measures to minimise such risks and the proposed studies for learning more about Furosemide Basi 10 mg/ml, solution for injection or infusion 's risks, are outlined below.
| basi laboratorios your health, our world HUH | RISK MANAGEMENT PLAN | |
| Código / Code : MOD.888 | Revisão / Revision : 1 | |
Measures to minimise the risks identified for medicinal products can be:
- Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals;
- Important advice on the medicine’s packaging;
- The authorised 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 — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.
Together, these measures constitute routine risk minimisation measures.
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.
II.A List of important risks and missing information
Important risks of Furosemide Basi 10 mg/ml, solution for injection or infusion 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 Furosemide Basi 10 mg/ml, solution for injection or infusion. 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 (e.g. on the long-term use of the medicine);
| List of important risks and missing information | |
| Important identified risks |
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| Important potential risks |
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| basi laboratorios your health, our world HUH | RISK MANAGEMENT PLAN | |
| Código / Code : MOD.888 | Revisão / Revision : 1 | |
| List of important risks and missing information | |
| Missing information |
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II.B Summary of important risks
The safety information in the proposed Product Information is aligned to the reference medicinal product.
II.C Post-authorisation development plan
II.C.1 Studies which are conditions of the marketing authorisation
There are no studies which are conditions of the marketing authorisation or specific obligation of Furosemide Basi 10 mg/ml, solution for injection or infusion.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Furosemide Basi 10 mg/ml, solution for injection or infusion.
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