Zum Inhalt

HealthOSArzneimittel

Arbeitsbereiche

Nachschlagen

Wirkstoffe & Arzneimittelsicherheit

Exakte Wirkstoffkennungen und zitierbare Passagen zu Wechselwirkungen, Gegenanzeigen und Nebenwirkungen.

Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.

RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 96 Präparate · 6744 Quellenpassagen. Automatisch aktualisiert, ohne menschliche Freigabe.

ReFacto AF

HOS-083891 · Fachinformation

Quellenpassagen (16)

Gegenanzeigen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 6

HOS-089601 · Präparat HOS-083891

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.

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 8cc0fe29768569a55e0703c8413d5a145077448bca5f7426ab9084406d167fa6 · Zeichen 0–91 im Abschnitt

Gegenanzeigen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.3 · PDF-Seite 6

HOS-089602 · Präparat HOS-083891

Known allergic reaction to hamster protein.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 77517df52f2c6a3666f71d365e1d6bf0b36e7d15d9d92ae049ccc625385f41bc · Zeichen 93–136 im Abschnitt

Wechselwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.5 · PDF-Seite 7

HOS-089603 · Präparat HOS-083891

No interactions of recombinant coagulation factor VIII products with other medicinal products have been reported.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage ae4cb2e83deefafd1eaa5dbf632abbf053ca43e808aeacfd636ccaf9ad5571c3 · Zeichen 0–113 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-089604 · Präparat HOS-083891

Summary of the safety profile

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage d55a523b6a19085dba8d780d613791739571d7f51eec366b153cafd8949337ee · Zeichen 0–29 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-089605 · Präparat HOS-083891

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed infrequently for ReFacto, and may in some cases progress to severe anaphylaxis including shock (see section 4.4).

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 62cbe6683b4600bd0f03277db0a7b55c6463a9d19fe50bb718f1f96278934771 · Zeichen 31–446 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-089606 · Präparat HOS-083891

Trace amounts of hamster protein may be present in ReFacto AF. Very rarely, development of antibodies to hamster protein has been observed, but there were no clinical sequelae. In a study of ReFacto, twenty of 113 (18%) previously treated patients (PTPs) had an increase in anti-CHO antibody titre, without any apparent clinical effect.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 534fa711cf3d0541dcfd2f48a3b04e48dc3b1c980020a03abf6f3ebc26b0cddd · Zeichen 448–784 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7–8

HOS-089607 · Präparat HOS-083891

7 Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ReFacto AF. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage bf8ced2d78de8cdacbd5e49e6a6ce6ab4499ccc5ce8b1ef14566dcde2e6da667 · Zeichen 840–1171 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089608 · Präparat HOS-083891

Tabulated list of adverse reactions

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage d51c90b617391dca447a849e03c6ddac1785fb6a36da5cf3e36f8f60e5aed8a9 · Zeichen 1173–1208 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089609 · Präparat HOS-083891

The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100). The table lists adverse reactions reported in the clinical trials with ReFacto or ReFacto AF. The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 765 subjects.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage c645a9f690da1de26afdb0335edba366ee51a6636c4951dc03bb5426db034b77 · Zeichen 1210–1695 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089610 · Präparat HOS-083891

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage bf1e2ee6545f9f7e70d8b9c8e057ab316ed35a907cd5300a59dd41d8b91f5d64 · Zeichen 1697–1798 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089611 · Präparat HOS-083891

System Organ Class Very common Common Uncommon ≥ 1/10 ≥ 1/100 ≥ 1/1,000 to to < 1/10 < 1/100 Blood and lymphatic FVIII inhibition FVIII inhibition system disorders (PUPs)* (PTPs)* Immune system Anaphylactic reaction disorders Metabolism and Decreased appetite nutrition disorders Nervous system Headache Dizziness Neuropathy peripheral; disorders somnolence; dysgeusia Cardiac disorders Angina pectoris; tachycardia; palpitations Vascular disorders Haemorrhage; Hypotension; thrombophlebitis; haematoma flushing Respiratory, thoracic Cough Dyspnoea and mediastinal disorders Gastrointestinal Diarrhoea; vomiting; disorders abdominal pain; nausea Skin and subcutaneous Urticaria; rash; pruritus Hyperhidrosis tissue disorders Musculoskeletal and Arthralgia Myalgia connective tissue disorders General disorders and Pyrexia Chills; catheter site Asthenia; injection site reaction; administration site related reaction injection site pain; injection site conditions inflammation Investigations Antibody test positive; Aspartate aminotransferase Anti-factor VIII increased; alanine antibody test positive aminotransferase increased; blood bilirubin increased; blood creatinine phosphokinase increased * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 706fe815ac2787c5e0817ec084895bb87e3f195532e8e5639c9c3f2f11cac918 · Zeichen 1801–4559 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089612 · Präparat HOS-083891

Paediatric population

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage f8de81cbdc552a4640ef023d45d58925828891a0a998c10f0caafbd8351b3249 · Zeichen 4561–4582 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8

HOS-089613 · Präparat HOS-083891

One event of cyst in an 11-year old patient and one event described as confusion in a 13-year old patient have been reported as possibly related to ReFacto AF treatment

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 53cc1dd2788f0849c857988b26154d4a6ca369ae30d6d45a5cbd49850ebd885e · Zeichen 4584–4752 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 8–9

HOS-089614 · Präparat HOS-083891

8 Safety of ReFacto AF was evaluated in studies that included both previously treated adults and previously treated children and adolescents (n=18, aged 12-16 years in a study and n=49, aged 7-16 years in a supporting study), with a tendency for higher frequencies of adverse reactions in children aged 7-16 years as compared to adults. Additional safety experience in children has been accrued through studies that encompassed both previously treated (n=18 aged <6 years and n=19 aged 6 to <12 years) and previously untreated (n=23 aged <6 years) patients and which supports a safety profile similar with that observed in adult patients.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 2c0c55bb4a7cbb86cd864f80b4cbbac0d6d9be47f9bbc2bdf717bd05952058a7 · Zeichen 4806–5445 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 9

HOS-089615 · Präparat HOS-083891

Reporting of suspected adverse reactions

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 822da43363cee11e87abeb55cf82453415269315377df150bb5de7dde8dd938f · Zeichen 5447–5487 im Abschnitt

Nebenwirkungen · ReFacto AF

ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 9

HOS-089616 · Präparat HOS-083891

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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

Vollständigen Kontext in der EMA-Fachinformation lesen →
Quellennachweis

Version 2025-03-05T15:12:00Z · SHA-256 8e1a3b6cc7bfba7f424249f78c7bab73f43a2b29dc7504859a655d85784fd1d6 · Passage 591ce3aa6d6555db7032d0551da929e990b92080da2928085827a75c666ec353 · Zeichen 5489–5803 im Abschnitt

This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.