Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.3 · PDF-Seite 4

HOS-147219 · Präparat HOS-099618

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-147220 · Präparat HOS-099618

The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following: For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected). For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): toremifene (HOS-085587) fusidic acid (HOS-086146)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-147223 · Präparat HOS-099618

Interactions potentially affecting the efficacy of sugammadex (displacement interactions): Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex. As a result recurrence of neuromuscular blockade might be observed. In this situation the patient must be ventilated. Administration of the medicinal product which caused displacement should be stopped in case of an infusion. In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of recurrence of neuromuscular blockade (approximately up to 15 minutes) after parenteral administration of another medicinal product occurring within a period of 7.5 hours after sugammadex administration.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): vecuronium (HOS-119611) rocuronium (HOS-119610)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-147226 · Präparat HOS-099618

Toremifene: For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur. Clinicians should be aware that the recovery of the T4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): toremifene (HOS-085587) vecuronium (HOS-119611) rocuronium (HOS-119610)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 6–7

HOS-147227 · Präparat HOS-099618

6 Intravenous administration of fusidic acid: The use of fusidic acid in the pre-operative phase may give some delay in the recovery of the T4/T1 ratio to 0.9. No recurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fusidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days. For re-administration of sugammadex see section 4.2.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): fusidic acid (HOS-086146)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-147228 · Präparat HOS-099618

Interactions potentially affecting the efficacy of other medicinal products (capturing interactions): Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations. If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or nonpharmacological interventions as appropriate.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-147229 · Präparat HOS-099618

Hormonal contraceptives: The interaction between 4 mg/kg sugammadex and a progestogen was predicted to lead to a decrease in progestogen exposure (34% of AUC) similar to the decrease seen when a daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness. For oestrogens, the effect is expected to be lower. Therefore the administration of a bolus dose of sugammadex is considered to be equivalent to one missed daily dose of oral contraceptive steroids (either combined or progestogen only). If sugammadex is administered at the same day as an oral contraceptive is taken reference is made to missed dose advice in the package leaflet of the oral contraceptive. In the case of non-oral hormonal contraceptives, the patient must use an additional non hormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): lead (HOS-085592)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-147230 · Präparat HOS-099618

Interactions due to the lasting effect of rocuronium or vecuronium: When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of recurrence of neuromuscular blockade. Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade. In case recurrence of neuromuscular blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section 4.2).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): vecuronium (HOS-119611) rocuronium (HOS-119610)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-147231 · Präparat HOS-099618

Interference with laboratory tests: In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay. Interference with this test is observed at sugammadex plasma concentrations of 100 microgram/mL (peak plasma level following 8 mg/kg bolus injection).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): progesterone (HOS-090753)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-147233 · Präparat HOS-099618

In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex resulted in maximum mean prolongations of aPTT by 17 and 22% respectively and of PT(INR) by 11 and 22% respectively. These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes). In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): vitamin K (HOS-091176) heparin (HOS-086930) dabigatran (HOS-112096) rivaroxaban (HOS-086236) heparinoids (HOS-119619)

Wechselwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-147236 · Präparat HOS-099618

Paediatric population No formal interaction studies have been performed. The above-mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-147237 · Präparat HOS-099618

Summary of the safety profile Sugammadex Mylan is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients. The causality of adverse events is therefore difficult to assess. The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to < 1/10)).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-147238 · Präparat HOS-099618

Table 2: Tabulated list of adverse reactions The safety of sugammadex has been evaluated in 3 519 unique subjects across a pooled phase I-III safety database. The following adverse reactions were reported in placebo-controlled trials where subjects received anaesthesia and/or neuromuscular blocking agents (1 078 subject exposures to sugammadex versus 544 to placebo): [Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000)]

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-147239 · Präparat HOS-099618

System organ class Frequencies Adverse reactions (Preferred terms) Immune system disorders Uncommon Drug hypersensitivity reactions (see section 4.4) Respiratory, thoracic and Common Cough mediastinal disorders Injury, poisoning and Common Airway complication of procedural anaesthesia complications Anaesthetic complication (see section 4.4)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-147240 · Präparat HOS-099618

Procedural hypotension

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-147241 · Präparat HOS-099618

Procedural complication

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-147242 · Präparat HOS-099618

Description of selected adverse reactions Drug hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below). In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-147243 · Präparat HOS-099618

8 These reactions varied from isolated skin reactions to serious systemic reactions (i.e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex. Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events. Severe hypersensitivity reactions can be fatal. In postmarketing reports, hypersensitivity has been observed for sugammadex as well as for sugammadex-rocuronium complex.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-147244 · Präparat HOS-099618

Airway complication of anaesthesia: Airway complications of anaesthesia included bucking against the endotracheal tube, coughing, mild bucking, arousal reaction during surgery, coughing during the anaesthetic procedure or during surgery, or anaesthetic procedure-related spontaneous breath of patient.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Sugammadex Mylan

Sugammadex Mylan 100 mg/mL solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-147245 · Präparat HOS-099618

Anaesthetic complication: Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. See section 4.4 light anaesthesia.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.