Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.3 · PDF-Seite 8

HOS-091569 · Präparat HOS-084365

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.

Gegenanzeigen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.3 · PDF-Seite 8

HOS-091570 · Präparat HOS-084365

Poorly controlled hypertension.

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

Wechselwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.5 · PDF-Seite 11

HOS-091571 · Präparat HOS-084365

The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances. However, there is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus. If Aranesp is given concomitantly with any of these treatments, blood levels of these substances should be monitored and the dosage adjusted as the haemoglobin rises.

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): tacrolimus (HOS-085202)

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11

HOS-091572 · Präparat HOS-084365

Summary of the safety profile

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11

HOS-091573 · Präparat HOS-084365

Identified adverse reactions associated with Aranesp are hypertension, stroke, thromboembolic events, convulsions, allergic reactions, rash/erythema and pure red cell aplasia (PRCA); see section 4.4.

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11

HOS-091574 · Präparat HOS-084365

Injection site pain was reported as attributable to treatment in studies where Aranesp was administered via subcutaneous injection. The injection site discomfort was generally mild and transient in nature and occurred predominantly after the first injection.

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11

HOS-091575 · Präparat HOS-084365

Tabulated list of adverse reactions

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11

HOS-091576 · Präparat HOS-084365

Incidence of adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11

HOS-091577 · Präparat HOS-084365

Data are presented separately for CRF and cancer patients reflecting the different adverse reaction profile in these populations.

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 11–12

HOS-091578 · Präparat HOS-084365

11 Chronic renal failure patients

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12

HOS-091579 · Präparat HOS-084365

Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO. In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis. Stroke was identified as an adverse reaction in an additional clinical study (TREAT, see section 5.1).

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12

HOS-091580 · Präparat HOS-084365

Incidence of adverse reactions from controlled clinical studies and post-marketing experience are:

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12

HOS-091581 · Präparat HOS-084365

MedDRA system organ class Subject incidence Adverse reaction Blood and lymphatic system Not known2 Pure red cell aplasia disorders Immune system disorders Very common Hypersensitivitya Nervous system disorders Common Strokeb Uncommon1 Convulsions Cardiac disorders Very common Hypertension Vascular disorders Uncommon Thromboembolic eventsc Uncommon1 Dialysis vascular access thrombosisd Skin and subcutaneous tissue Common Rash/erythemae disorders Not known2 SJS/TEN, erythema multiforme, blistering, skin exfoliation General disorders and administration Common Injection site pain site conditions Uncommon1 Injection site bruising Injection site haemorrhage Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and 980211) except for the adverse reaction of stroke which was identified as an adverse reaction in the TREAT study (study 20010184). 1 Adverse reactions identified in the post-marketing environment. Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of adverse reactions identified in the post-marketing setting was determined using the “Rule of three”. 2 Frequency cannot be estimated from the available data. a Hypersensitivity events includes all events under the hypersensitivity SMQ. b Stroke events includes PT haemorrhagic stroke, ischaemic stroke, cerebrovascular accident, and stroke in evolution. c Thromboembolic events adverse reaction includes PT embolism arterial, thrombophlebitis, thrombosis, venous thrombosis limb. d Dialysis vascular access thrombosis includes all adverse reactions under the dialysis vascular access thrombosis AMQ e Rash/erythema adverse reaction includes PT rash, rash pruritic, rash macular, rash generalised, erythema.

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12

HOS-091582 · Präparat HOS-084365

Cancer patients

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12

HOS-091583 · Präparat HOS-084365

Adverse reactions were determined based on pooled data from eight randomised, double-blind, placebo-controlled studies of Aranesp with a total of 4,630 patients (Aranesp 2,888, placebo 1,742). Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies (e.g., lymphoma, multiple myeloma) were enrolled in the clinical studies.

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12

HOS-091584 · Präparat HOS-084365

MedDRA system organ class Subject incidence Adverse reaction Immune system disorders Very common Hypersensitivitya Nervous system disorders Uncommon1 Convulsions Cardiac disorders Common Hypertension Vascular disorders Common Thromboembolic eventsb, including pulmonary embolism

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 12–13

HOS-091585 · Präparat HOS-084365

12 MedDRA system organ class Subject incidence Adverse reaction Skin and subcutaneous tissue Common Rash/erythemac disorders Not known2 SJS/TEN, erythema multiforme, blistering, skin exfoliation General disorders and administration Common Oedemad site conditions Common Injection site paine Uncommon1 Injection site bruising Injection site haemorrhage 1 ADRs identified in the post marketing environment. Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using the “Rule of three”. 2 Frequency cannot be estimated from the available data. Source: includes 8 randomised, double-blind, placebo-controlled studies (980291-schedule 1 and 2, 980297, 990114, 20000161, 20010145, 20030232, and 20070782) a Hypersensitivity events includes all events under the hypersensitivity SMQ. b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, pulmonary embolism, as well as thrombosis in device from SOC product issues. c Rash adverse reactions includes PT rash, rash pruritic, rash generalised, rash papular, erythema, exfoliative rash, rash maculo-papular, rash vesicular as well as rash pustular from SOC Infections and Infestations. d Oedema: includes PT Oedema Peripheral, Oedema, Generalised Oedema, Oedema due to Cardiac Disease, Face oedema e Injection site pain adverse reaction includes PT injection site pain, administration site pain, catheter site pain, infusion site pain and vessel puncture site pain.

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 13

HOS-091586 · Präparat HOS-084365

Description of selected adverse reactions

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 13

HOS-091587 · Präparat HOS-084365

Chronic renal failure patients

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

Nebenwirkungen · Aranesp

Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. Aranesp 30 micrograms solution for injection in pre-filled syringe. Aranesp 40 micrograms solution for injection in pre-filled syringe. Aranesp 50 micrograms solution for injection in pre-filled syringe. Aranesp 60 micrograms solution for injection in pre-filled syringe. Aranesp 80 micrograms solution for injection in pre-filled syringe. Aranesp 100 micrograms solution for injection in pre-filled syringe. Aranesp 130 micrograms solution for injection in pre-filled syringe. Aranesp 150 micrograms solution for injection in pre-filled syringe. Aranesp 300 micrograms solution for injection in pre-filled syringe. Aranesp 500 micrograms solution for injection in pre-filled syringe. Aranesp 10 micrograms solution for injection in pre-filled pen. Aranesp 15 micrograms solution for injection in pre-filled pen. Aranesp 20 micrograms solution for injection in pre-filled pen. Aranesp 30 micrograms solution for injection in pre-filled pen. Aranesp 40 micrograms solution for injection in pre-filled pen. Aranesp 50 micrograms solution for injection in pre-filled pen. Aranesp 60 micrograms solution for injection in pre-filled pen. Aranesp 80 micrograms solution for injection in pre-filled pen. Aranesp 100 micrograms solution for injection in pre-filled pen. Aranesp 130 micrograms solution for injection in pre-filled pen. Aranesp 150 micrograms solution for injection in pre-filled pen. Aranesp 300 micrograms solution for injection in pre-filled pen. Aranesp 500 micrograms solution for injection in pre-filled pen. Aranesp 25 micrograms solution for injection in vial. Aranesp 40 micrograms solution for injection in vial. Aranesp 60 micrograms solution for injection in vial. Aranesp 100 micrograms solution for injection in vial. Aranesp 200 micrograms solution for injection in vial. Aranesp 300 micrograms solution for injection in vial. · Abschnitt 4.8 · PDF-Seite 13

HOS-091588 · Präparat HOS-084365

Stroke was reported as common in CRF patients in TREAT (see section 5.1).

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