Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.3 · PDF-Seite 10

HOS-117283 · Präparat HOS-094569

- 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 · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.3 · PDF-Seite 10

HOS-117284 · Präparat HOS-094569

- Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetin alfa HEXAL or any other erythropoietin (see section 4.4).

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

Gegenanzeigen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.3 · PDF-Seite 10–11

HOS-117285 · Präparat HOS-094569

10 - Uncontrolled hypertension.

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

Gegenanzeigen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.3 · PDF-Seite 11

HOS-117286 · Präparat HOS-094569

- All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Epoetin alfa HEXAL.

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

Gegenanzeigen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.3 · PDF-Seite 11

HOS-117287 · Präparat HOS-094569

The use of Epoetin alfa HEXAL in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.

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

Gegenanzeigen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.3 · PDF-Seite 11

HOS-117288 · Präparat HOS-094569

- Surgery patients who for any reason cannot receive adequate antithrombotic prophylaxis.

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

Wechselwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.5 · PDF-Seite 15

HOS-117289 · Präparat HOS-094569

No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products. Medicinal products that decrease erythropoiesis may decrease the response to epoetin alfa.

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

Wechselwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.5 · PDF-Seite 15

HOS-117290 · Präparat HOS-094569

Since cyclosporin is bound by RBCs there is potential for a medicinal product interaction. If epoetin alfa is given concomitantly with cyclosporin, blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the haematocrit rises.

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

Wechselwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.5 · PDF-Seite 15

HOS-117291 · Präparat HOS-094569

No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.

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

Wechselwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.5 · PDF-Seite 15

HOS-117292 · Präparat HOS-094569

In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40 000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.

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): trastuzumab (HOS-090897)

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117294 · Präparat HOS-094569

Summary of the safety profile

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117295 · Präparat HOS-094569

The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension. Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117296 · Präparat HOS-094569

The most frequently occurring adverse drug reactions observed in clinical studies of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache. Influenza-like illness may occur especially at the start of treatment.

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117297 · Präparat HOS-094569

Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117298 · Präparat HOS-094569

An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.4).

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117299 · Präparat HOS-094569

Tabulated list of adverse reactions

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117300 · Präparat HOS-094569

Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects. Included were 228 epoetin alfa-treated CRF subjects in 4 CRF studies (2 studies in pre-dialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies. Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these studies are shown in the table below.

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117301 · Präparat HOS-094569

Frequency estimate: 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), 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 · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16

HOS-117302 · Präparat HOS-094569

MedDRA System Organ Adverse Reaction (Preferred Frequency Classification (SOC) Term Level) Blood and lymphatic system Pure red cell aplasia3, Rare disorders Thrombocythaemia Metabolism and nutrition Hyperkalaemia1 Uncommon disorders Hypersensitivity3 Uncommon Immune system disorders Anaphylactic reaction3 Rare Headache Common Nervous system disorders Convulsion Uncommon Hypertension, Venous and Common Vascular disorders arterial thromboses2 Hypertensive crisis3 Not known Respiratory, thoracic and Cough Common mediastinal disorders Respiratory tract congestion Uncommon Gastrointestinal disorders Diarrhoea, Nausea, Vomiting Very common Rash Common Skin and subcutaneous tissue Urticaria3 Uncommon disorders Angioneurotic oedema3 Not known Musculoskeletal and connective Arthralgia, Bone pain, Myalgia, Common tissue disorders Pain in extremity Congenital, familial and genetic Porphyria acute3 Rare

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

Nebenwirkungen · Epoetin Alfa Hexal

Epoetin alfa HEXAL 1 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3 000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4 000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6 000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7 000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8 000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9 000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10 000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20 000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30 000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40 000 IU/1 mL solution for injection in a pre-filled syringe · Abschnitt 4.8 · PDF-Seite 16–17

HOS-117303 · Präparat HOS-094569

16 MedDRA System Organ Adverse Reaction (Preferred Frequency Classification (SOC) Term Level) disorders Pyrexia Very common Chills, Influenza like illness, General disorders and Injection site reaction, Oedema Common administration site conditions peripheral Medicinal product ineffective3 Not known Anti-erythropoietin antibody Investigations Rare positive 1 Common in dialysis 2 Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms 3 Addressed in the subsection below and/or in section 4.4

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