Sugammadex Atnahs 100 mg/ml Injektionslösung - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary of risk management plan for Sugammadex 100mg/mL solution for injection

This is a summary of the risk management plan (RMP) for sugammadex 100mg/mL solution for injection. The RMP details important risks of sugammadex 100mg/mL solution for injections, how these risks can be minimised, and how more information will be obtained about sugammadex 100mg/mL solution for injections, risks and uncertainties (missing information).

Sugammadex 100mg/mL solution for injections, summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how sugammadex 100mg/mL solution for injections should be used.

• I. The medicine and what it is used for

Sugammadex is used to reverse the effect of the muscle relaxants rocuronium and vecuronium. Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe. Muscle relaxants make it easier for the surgeon to perform an operation. Sugammadex is used to speed up the recovery from the muscle relaxant, usually at the end of the operation. Sugammadex can be used in adults who have received rocuronium and vecuronium, and in children and adolescents who have received rocuronium. The medicine can only be obtained with a prescription.

• II. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of sugammadex 100mg/mL solution for injections together with measures to minimise such risks and the proposed studies for learning more about sugammadex 100mg/mL solution for injections risks, are outlined below.

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 sugammadex 100mg/mL solution for injections are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. 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 sugammadex 100mg/mL solution for injections. 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).

• II.B Summary of important risks