Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Retacrit

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

HOS-119572 · Präparat HOS-094973

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 · Retacrit

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

HOS-119573 · Präparat HOS-094973

Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Retacrit 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 · Retacrit

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

HOS-119574 · Präparat HOS-094973

Uncontrolled hypertension.

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

Gegenanzeigen · Retacrit

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

HOS-119575 · Präparat HOS-094973

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

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

Gegenanzeigen · Retacrit

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

HOS-119576 · Präparat HOS-094973

The use of Retacrit 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 · Retacrit

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

HOS-119577 · Präparat HOS-094973

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 · Retacrit

Retacrit 1 000 IU/0.3 mL solution for injection in pre-filled syringe Retacrit 2 000 IU/0.6 mL solution for injection in pre-filled syringe Retacrit 3 000 IU/0.9 mL solution for injection in pre-filled syringe Retacrit 4 000 IU/0.4 mL solution for injection in pre-filled syringe Retacrit 5 000 IU/0.5 mL solution for injection in pre-filled syringe Retacrit 6 000 IU/0.6 mL solution for injection in pre-filled syringe Retacrit 8 000 IU/0.8 mL solution for injection in pre-filled syringe Retacrit 10 000 IU/1 mL solution for injection in pre-filled syringe Retacrit 20 000 IU/0.5 mL solution for injection in pre-filled syringe Retacrit 30 000 IU/0.75 mL solution for injection in pre-filled syringe Retacrit 40 000 IU/1 mL solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 14–15

HOS-119578 · Präparat HOS-094973

14 No evidence exists that indicates that treatment with epoetin zeta 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 · Retacrit

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

HOS-119579 · Präparat HOS-094973

Medicinal products that decrease erythropoiesis may decrease the response to epoetin zeta.

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

Wechselwirkungen · Retacrit

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

HOS-119580 · Präparat HOS-094973

Since cyclosporin is bound by RBCs there is potential for a drug interaction. If epoetin zeta 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 · Retacrit

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

HOS-119581 · Präparat HOS-094973

No evidence exists that indicates an interaction between epoetin zeta 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 · Retacrit

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

HOS-119582 · Präparat HOS-094973

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 · Retacrit

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

HOS-119583 · Präparat HOS-094973

Summary of the safety profile

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

Nebenwirkungen · Retacrit

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

HOS-119584 · Präparat HOS-094973

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 · Retacrit

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

HOS-119585 · Präparat HOS-094973

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 · Retacrit

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

HOS-119586 · Präparat HOS-094973

15 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 · Retacrit

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

HOS-119587 · Präparat HOS-094973

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 · Retacrit

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

HOS-119588 · Präparat HOS-094973

Tabulated list of adverse reactions

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

Nebenwirkungen · Retacrit

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

HOS-119589 · Präparat HOS-094973

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 · Retacrit

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

HOS-119590 · Präparat HOS-094973

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 · Retacrit

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

HOS-119591 · Präparat HOS-094973

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 Immune system disorders Hypersensitivity3 Uncommon Anaphylactic reaction3 Rare Nervous system disorders Headache Common Convulsion Uncommon Vascular disorders Hypertension, Venous and Common arterial 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 Arthralgia, Bone pain, Common connective tissue disorders Myalgia, Pain in extremity Congenital, familial and Porphyria acute3 Rare genetic disorders General disorders and Pyrexia Very common administration site conditions Chills, Influenza like illness, Common Injection site reaction, Oedema peripheral Drug ineffective3 Not known Investigations Anti-erythropoietin antibody Rare positive

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