Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 4

HOS-135958 · Präparat HOS-097800

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 · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135959 · Präparat HOS-097800

Semaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. Semaglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption.

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

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135960 · Präparat HOS-097800

Paracetamol

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

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135961 · Präparat HOS-097800

Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a standardised meal test. Paracetamol AUC0-60min and Cmax were decreased by 27% and 23%, respectively, following concomitant use of semaglutide 1 mg. The total paracetamol exposure (AUC0-5h) was not affected. No clinically relevant effect on the rate of gastric emptying was observed with semaglutide 2.4 mg, following 20 weeks of administration of semaglutide, probably due to a tolerance effect. No dose adjustment of paracetamol is necessary when administered with semaglutide.

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

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135962 · Präparat HOS-097800

Oral contraceptives

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

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135963 · Präparat HOS-097800

Semaglutide is not anticipated to decrease the effect of oral contraceptives as semaglutide did not change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree when an oral contraceptive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) was co-administered with semaglutide. Exposure of ethinylestradiol was not affected; an increase of 20% was observed for levonorgestrel exposure at steady state. Cmax was not affected for any of the compounds.

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): levonorgestrel (HOS-089677)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135964 · Präparat HOS-097800

Atorvastatin

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): atorvastatin (HOS-086304)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135965 · Präparat HOS-097800

Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg). Atorvastatin Cmax was decreased by 38%. This was assessed not to be clinically relevant.

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): atorvastatin (HOS-086304)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135966 · Präparat HOS-097800

Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin (0.5 mg).

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): digoxin (HOS-086172)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135967 · Präparat HOS-097800

Metformin

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): metformin (HOS-091032)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6

HOS-135968 · Präparat HOS-097800

Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days.

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): metformin (HOS-091032)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 6–7

HOS-135969 · Präparat HOS-097800

6 Warfarin and other coumarin derivatives

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): coumarin (HOS-088372) warfarin (HOS-085950)

Wechselwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-135971 · Präparat HOS-097800

Semaglutide did not change the overall exposure or Cmax of R- and S-warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner. However, cases of decreased INR have been reported during concomitant use of acenocoumarol and semaglutide. Upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of INR is recommended.

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): coumarin (HOS-088372) acenocoumarol (HOS-109456) warfarin (HOS-085950)

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-135973 · Präparat HOS-097800

Summary of safety profile

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

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-135974 · Präparat HOS-097800

In 8 phase 3a trials 4 792 patients were exposed to semaglutide up to 1 mg. The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea (very common) and vomiting (common). In general, these reactions were mild or moderate in severity and of short duration.

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

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-135975 · Präparat HOS-097800

Tabulated list of adverse reactions

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

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-135976 · Präparat HOS-097800

Table 1 lists adverse reactions identified in all phase 3 trials (including the long-term cardiovascular outcomes trial) and post-marketing reports in patients with type 2 diabetes mellitus (further described in section 5.1). The frequencies of the adverse reactions (except diabetic retinopathy complications,

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

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7–8

HOS-135977 · Präparat HOS-097800

7 see footnote in Table 1) are based on a pool of the phase 3a trials excluding the cardiovascular outcomes trial (see text below the table for additional details).

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

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-135978 · Präparat HOS-097800

The reactions are listed below by system organ class and absolute frequency. Frequencies are defined as: 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) and not known: (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

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

Nebenwirkungen · Ozempic

Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen Ozempic 0.25 mg solution for injection in pre-filled syringe Ozempic 0.5 mg solution for injection in pre-filled syringe Ozempic 1 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-135979 · Präparat HOS-097800

Table 1 Frequency of adverse reactions of semaglutide MedDRA Very common Common Uncommon Rare Very Rare Not known system organ class Immune Hypersensiti Anaph system vityc ylactic disorders reactio n Metabolism Hypoglycaemiaa Hypoglyca and nutrition when used with emiaa when disorders insulin or used with sulfonylurea other oral antidiabeti cs (OAD)

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