Sugammadex Provepharm 100 mg/ml Injektionslösung – Beipackzettel, Nebenwirkungen, Dosierung

Summary of risk management plan Sugammadex Provepharm 100 mg^mL, solution for in^ection (Sugammadex)

This is a summary of the risk management plan (RMP) for Suga mmadex Provepharm 100 mg^mL, solution for in^ection. The RMP deta ils important risks of Sugammadex Provepharm 100 mg^mL, solution for in^ection, how these risks can be minimised and how more information will be obtained about the risks and unce rta inties (missing information) of Suga mmadex Provepharm 100 mg^mL, solution for in^ection.

The summary of product cha ra cteristics (SmPC) Sugammadex Provepharm 100 mg^mL, solution for in^ection a nd its package leaflet give essentia l information to hea lthca re professionals and patients on how Sugammadex Provepharm 100 mg^mL, solution for in^ection should be used.

This summary of the RMP of Suga mmadex Provepharm 100 mg^mL, solution for in^ection should be read in the context of all this information including the assessment report of the evaluation and its pla in-la nguage summary, all which is part of the European Public Assessment Report (EPAR).

Importa nt new concerns or changes to the current ones will be included in updates of RMP of Sugammadex Provepharm 100 mg^mL, solution for in^ection.

• I. The medicine and what it is used for

Sugammadex Provepharm 100 mg^mL, solution for in^ection is a uthorised to reverse diffe re nt levels of rocuronium or vecuronium induced neuromuscular blockade (see SmPC for the full indication).

It contains sugammadex as the active substance and it is given by an intravenously single bolus in^ection.

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

Importa nt risks of Sugammadex Provepharm 100 mg^mL, solution for in^ection, together with measures to minimise such risks and the proposed studies for learning more about the risks of Sugammadex Provepharm 100 mg^mL, solution for in^ection, are outlined below.

Measures to minimise the risks identified for med icina l products can be:

• Specific information, such as warnings, precautions, and a dvice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals;
• Importa nt a dvice on the medicineʼs packaging;
• The authorised pack size — the amount of med icine in a pack is chosen so to ensure that the med icine is used correctly;
• The medicineʼs legal status — the way a medicine is supplied to the patient (e.g. with or without p re scriptio n) can help to minimise its risks.

Together, these measures co n stitute routine risk minimisation measures.

If important info rma tio n that may affect the safe use of Sugammadex Provepharm 100 mg^mL, solution for in^ection is not yet available, it is listed under ^missing informationʼ below.

• II.A List of important risks and missing information

Importa nt risks of Sugammadex Prove pharm 100 mg^mL, solution for in^ection , are risks that need specia l risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered.

Importa nt risks can be regarded as identified or potential.

Ide ntified risks are concerns for w hich there is sufficient proof of a link with the use of Sugammadex Provepharm 100 mg^mL, solution for in^ection.

Pote ntial risks are concerns for which an association with the use of this medicine is possible based on availa ble data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the med icina l 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	– Delayed onset time or insufficient neuromuscular blockade at retreatment with stero ida l neuromuscular blocking agent – Neuromuscular block prolonged (Delayed recovery) – Re-occurrence of neuromuscular blockade – Anesthetic co mp lica tio n ^ Light a nesthesia – Use of sugammadex in patients with renal impa irment
Important potentia l risks	– Drug hype rse nsitivity – Ca pturing interactions – Displacement interactions
Missing information	– Effect on values for laboratory pa rameters of blood coagulation time (aPTT, PT (inr), PT) – Exposure in infants and neo nates – Exposure in pregnancy – Excretion of suga mmadex in human milk

• II.B Summary of important risks