Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Soluprep steril gefärbt 2 % w/v + 70 % v/v Lösung zur Anwendung auf der Haut
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)
Soluprep steril 2 % w/v + 70 % v/v Lösung zur Anwendung auf der Haut
Soluprep steril gefärbt 2 % w/v + 70 % v/v Lösung zur Anwendung auf der Haut
Administrative Information:
| Wirkstoffe | Chlorhexidinbis(D-gluconat) 2-Propanol (Ph.Eur.) |
| ATC-Code | D08AC52 |
| Darreichungsform | Lösung zur Anwendung auf der Haut |
| Art der Anwendung | Anwendung auf der Haut |
| Inhaber der Zulassung | 3M Deutschland GmbH Carl-Schurz-Str. 1 41453 Neuss Deutschland |
| Zulassungsnummern | 2201659.00.00 2201660.00.00 |
| Datum der Zulassung | 29.01.2020 |
| Verkaufsabgrenzung | apothekenpflichtig |
| Version und Datum des Risikomanagement-Plans | 1.3 / 15.01.2019 |
| Datum der Genehmigung des RMPs | 03.02.2020 |
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 hier (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.Bund hier finden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 18. März 2021 veröffentlicht.
-
(1)
-
(2)
Part VI: Summary of the risk management plan
Summary of risk management plan for 3M® CHG/IPA Film-Forming Sterile Cutaneous Solution (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol)
This is a summary of the risk management plan (RMP) for 3M® CHG/IPA Film-Forming cutaneous solution. The RMP details important risks of 3M® CHG/IPA Film-Forming cutaneous solution, how these risks can be minimised, and how more information will be obtained about 3M® CHG/IPA Film-Forming cutaneous solution 's risks and uncertainties (missing information).
3M® CHG/IPA Film-Forming cutaneous solution’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how 3M® CHG/IPA Film-Forming cutaneous solution should be used.
-
I. The medicine and what it is used for
3M® CHG/IPA Film-Forming cutaneous solution is authorised for disinfection of the skin prior to surgery to help reduce bacteria that can potentially cause skin infection (see SmPC for the full indication). It contains 2% chlorhexidine gluconate and 70% isopropyl alcohol as the active substances and it is a cutaneous solution applied to the treatment area/surgical site (e.g. abdomen or arm).
-
II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of 3M® CHG/IPA Film-Forming cutaneous solution, together with measures to minimise such risks and the proposed studies for learning more about 3M® CHG/IPA Film-Forming cutaneous solution's risks, are outlined below.
Specific information, such as warnings, precautions, and advice on correct use are provided in the package leaflet and SmPC addressed to patients and healthcare professionals;
Each pack contains either a 10.5ml or 26ml sterile solution sealed in a glass ampoule. The glass ampoule is housed within a plastic applicator and sealed in a pouch. The product is sterile and is for single use only;
Although the product has a legal status of GSL, it will be administered in a controlled environment by qualified personnel, which will 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, including PSUR assessment, so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
If important information that may affect the safe use of 3M® CHG/IPA Film-Forming cutaneous solution is not yet available, it is listed under ‘missing information’ below.
-
II.A List of important risks and missing information
Important risks of 3M® CHG/IPA Film-Forming cutaneous solution 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 3M® CHG/IPA Film
Forming cutaneous solution.
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 |
|
| Important potential risks |
|
| Missing information |
|
-
II.B Summary of important risks
Important identified risks
| Anaphylaxis and Hypersensitivity | |
| Evidence for linking the risk to the medicine | Anaphylactic shock and anaphylactoid reactions are listed as a designated medical event by the EMA as an ADR that deserves special attention. |
| Risk factors and risk groups | The product should not be used in patients with a previous history of allergy to chlorhexidine-containing products. |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
| Chemical burns | |
| Evidence for linking the risk to the medicine | The Drug Safety Update (June 2014) issued by the MHRA [3] highlighted the risk of chemical injury to premature infants following the use of chlorhexidine solutions. This was further substantiated and supported by PRAC in September 2014. [4] |
| Risk factors and risk groups | Infants less than 32 weeks gestation and within the first few days of life. Risk increases with prolonged contact time and/or increased surface area required for disinfection. |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
Important potential risks
| Inappropriate application to other sites | |
| Evidence for linking the risk to the medicine | Chlorhexidine has limited information on its neurotoxicity. Alcohol-induced neurolysis is well established. |
| Risk factors and risk groups | Not applicable |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
| Accidental exposure to eyes, ears and mouth | |
| Evidence for linking the risk to the medicine | Whilst injection of 5ul of 0.05% aqueous chlorhexidine into the anterior chamber of the eye (Henschen and Olson, 1984) produced adrenergic nerve degeneration in rates and the authors postulated that the thin unmyelinated nerves of the central nervous system might be equally affected. [2] Furthermore, alcohol which is the main constituent of chlorhexidine solutions is neurotoxic. |
| Risk factors and risk groups | Not applicable |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
| Fire hazard | |
| Evidence for linking the risk to the medicine | Alcohol is well known to be highly flammable. |
| Risk factors and risk groups | Not applicable |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
Missing information
| Fertility, pregnancy and lactation | |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
| Drug-drug interactions | |
| Risk minimisation measures | Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection: AE follow-up form for adverse reaction. |
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 3M® CHG/IPA Film-Forming cutaneous solution.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for 3M® CHG/IPA Film-Forming cutaneous solution.
3M Healthcare Ltd.
Page 36
CONTROLLED DOCUMENT