Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Silapo

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

HOS-117521 · Präparat HOS-094633

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 · Silapo

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

HOS-117522 · Präparat HOS-094633

Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Silapo or any other erythropoietin (see section 4.4 - Pure Red Cell Aplasia (PRCA)).

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

Gegenanzeigen · Silapo

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

HOS-117523 · Präparat HOS-094633

Uncontrolled hypertension.

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

Gegenanzeigen · Silapo

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

HOS-117524 · Präparat HOS-094633

All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Silapo.

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

Gegenanzeigen · Silapo

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

HOS-117525 · Präparat HOS-094633

The use of Silapo 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 · Silapo

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

HOS-117526 · Präparat HOS-094633

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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 14

HOS-117527 · Präparat HOS-094633

No evidence exists that indicates that treatment with erythropoietin alters the metabolism of other medicinal products.

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

Wechselwirkungen · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 14

HOS-117528 · Präparat HOS-094633

Medicinal products that decrease erythropoiesis may decrease the response to Silapo.

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

Wechselwirkungen · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 14

HOS-117529 · Präparat HOS-094633

Since ciclosporin is bound by RBCs there is potential for a drug interaction. If Silapo is given concomitantly with ciclosporin, blood levels of ciclosporin should be monitored and the dose of ciclosporin adjusted as the haematocrit rises.

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

Wechselwirkungen · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 14

HOS-117530 · Präparat HOS-094633

No evidence exists that indicates an interaction between Silapo and G-CSF or 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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 14

HOS-117531 · Präparat HOS-094633

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): epoetin alfa (HOS-117282) trastuzumab (HOS-090897)

Nebenwirkungen · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15

HOS-117532 · Präparat HOS-094633

Summary of the safety profile 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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15

HOS-117533 · Präparat HOS-094633

The most frequently occurring adverse drug reactions observed in clinical trials 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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15

HOS-117534 · Präparat HOS-094633

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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15

HOS-117535 · Präparat HOS-094633

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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15

HOS-117536 · Präparat HOS-094633

Tabulated list of adverse reactions 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 chronic renal failure studies (2 studies in predialysis [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 trials are shown in the table below.

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

Nebenwirkungen · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15

HOS-117537 · Präparat HOS-094633

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 · Silapo

Silapo 1 000 IU/0.3 mL solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 mL solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 mL solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 mL solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 mL solution for injection in pre-filled syringe Silapo 10 000 IU/1 mL solution for injection in pre-filled syringe Silapo 20 000 IU/0.5 mL solution for injection in pre-filled syringe Silapo 30 000 IU/0.75 mL solution for injection in pre-filled syringe Silapo 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 15–16

HOS-117538 · Präparat HOS-094633

15  MedDRA System Organ Adverse Reaction (Preferred Term Frequency Classification (SOC) Level) Blood and lymphatic system Pure red cell aplasia3, Rare disorders Thrombocythemia Metabolism and nutrition Hyperkalaemia1 Uncommon disorders Immune system disorders Hypersensitivity3 Uncommon Anaphylactic reaction3 Rare Nervous system disorders Headache Common Convulsion Uncommon Vascular disorders Hypertension, Venous and arterial Common thrombosis2 Hypertensive crisis3 Not known Respiratory, thoracic and Cough Common mediastinal disorders Respiratory tract congestion Uncommon Gastrointestinal disorders Diarrhoea, Nausea, Vomiting Very common Skin and subcutaneous tissue Rash Common disorders Urticaria3 Uncommon Angioneurotic oedema3 Not known Musculoskeletal and connective Arthralgia, Bone pain, Myalgia, Pain Common tissue disorders in extremity Congenital, familial and genetic Porphyria acute3 Rare disorders General disorders and Pyrexia Very common administration site conditions Chills, Influenza like illness, Injection Common site reaction, Oedema peripheral Drug ineffective3 Not known Investigations Anti-erythropoeitin antibody positive Rare 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.

Nebenwirkungen · Silapo

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

HOS-117539 · Präparat HOS-094633

Description of selected adverse reactions Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).

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

Nebenwirkungen · Silapo

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

HOS-117540 · Präparat HOS-094633

Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).

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