Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 7

HOS-086017 · Präparat HOS-083248

Hypersensitivity to the active substance or 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 · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 7

HOS-086018 · Präparat HOS-083248

Poorly controlled hypertension.

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

Gegenanzeigen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 7

HOS-086019 · Präparat HOS-083248

In the indication “increasing the yield of autologous blood”: myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.

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

Wechselwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 10

HOS-086020 · Präparat HOS-083248

The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products. Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.

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): cisplatin (HOS-086022) etoposide (HOS-086021) fluorouracil (HOS-086023) cyclophosphamide (HOS-084539)

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086024 · Präparat HOS-083248

Summary of the safety profile

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086025 · Präparat HOS-083248

Based on results from clinical trials including 1 725 patients, approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions.

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086026 · Präparat HOS-083248

Anaemic patients with chronic renal failure The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4). Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086027 · Präparat HOS-083248

Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms), see section 4.4. In most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4). In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086028 · Präparat HOS-083248

In isolated cases, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported. In case anti-erythropoietin antibody-mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4). Adverse reactions are listed in Table 1 below.

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086029 · Präparat HOS-083248

Patients with cancer Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (see section 4.4).

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086030 · Präparat HOS-083248

In some patients, a fall in serum iron parameters is observed (see section 4.4).

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086031 · Präparat HOS-083248

Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo. In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls; this is not associated with any increase in thromboembolic mortality compared with controls. Adverse reactions are listed in Table 2 below.

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086032 · Präparat HOS-083248

Patients in an autologous blood pre-donation programme Patients in an autologous blood pre-donation programme have been reported to show a slightly higher frequency of thromboembolic events. However, a causal relationship with treatment with NeoRecormon could not be established.

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086033 · Präparat HOS-083248

In placebo-controlled trials, temporary iron deficiency was more pronounced in patients treated with NeoRecormon than in controls (see section 4.4). Adverse reactions are listed in Table 3 below.

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086034 · Präparat HOS-083248

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.

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086035 · Präparat HOS-083248

Tabulated list of adverse reactions

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11

HOS-086036 · Präparat HOS-083248

Adverse reactions are listed according to MedDRA system organ class and frequency category. Frequency categories are defined using the following convention: 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 · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 11–12

HOS-086037 · Präparat HOS-083248

11 Table 1: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in CKD patients System organ class Adverse reaction Frequency Vascular disorders Hypertension Common Hypertensive crisis Uncommon Nervous system disorders Headache Common Blood and lymphatic Shunt thrombosis Rare system disorders Thrombocytosis Very rare

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 12

HOS-086038 · Präparat HOS-083248

Table 2: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in cancer patients System organ class Adverse reaction Frequency Vascular disorders Hypertension Common Blood and lymphatic Thromboembolic event Common system disorders Nervous system disorders Headache Common

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

Nebenwirkungen · NeoRecormon

NeoRecormon 500 IU solution for injection in pre-filled syringe NeoRecormon 2 000 IU solution for injection in pre-filled syringe NeoRecormon 3 000 IU solution for injection in pre-filled syringe NeoRecormon 4 000 IU solution for injection in pre-filled syringe NeoRecormon 5 000 IU solution for injection in pre-filled syringe NeoRecormon 6 000 IU solution for injection in pre-filled syringe NeoRecormon 10 000 IU solution for injection in pre-filled syringe NeoRecormon 20 000 IU solution for injection in pre-filled syringe NeoRecormon 30 000 IU solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 12

HOS-086039 · Präparat HOS-083248

Table 3: Adverse reactions attributed to the treatment with NeoRecormon in controlled clinical trials in patients in an autologous blood pre-donation programme System organ class Adverse reaction Frequency Nervous system disorders Headache Common

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