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.
Gegenanzeigen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 5
HOS-086886 · Präparat HOS-083385
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 8cc0fe29768569a55e0703c8413d5a145077448bca5f7426ab9084406d167fa6 · Zeichen 0–91 im Abschnitt
Gegenanzeigen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 5
HOS-086887 · Präparat HOS-083385
Known allergic reaction to hamster proteins.
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage fa28b536976ae55b4ad0928d9d574a1b9cba559db9c7e0967b776f18862ee635 · Zeichen 93–137 im Abschnitt
Wechselwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 7
HOS-086888 · Präparat HOS-083385
No interactions of human coagulation factor IX (rDNA) 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 68b5424b1047f53f946775c3e042eed3cfdc8b78bbfede982ec9d36ebe2f6734 · Zeichen 0–112 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-086889 · Präparat HOS-083385
Summary of the safety profile
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 and
may in some cases progress to severe anaphylaxis (including shock). In some cases, these reactions
have progressed to severe anaphylaxis, and they have occurred in close temporal association with
development of factor IX inhibitors (see also section 4.4). Nephrotic syndrome has been reported
following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors
and a history of allergic reaction.
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage aae82522b70f3ff93effaabada50f40736b003385c05ef6326714921c19b6b33 · Zeichen 0–763 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-086890 · Präparat HOS-083385
Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has
been observed.
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 06e0bbc5fec93fc18ebece634f60dc427422d05601d857322135fce8800771da · Zeichen 765–880 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-086891 · Präparat HOS-083385
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX. If such
inhibitors occur, the condition will 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 27477750c392d8ac5ee9b31ba458c66df846a372efa0cdfb68aaa4e8e4b65328 · Zeichen 882–1156 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-086892 · Präparat HOS-083385
There is a potential risk of thromboembolic episodes following the administration of factor IX
products, 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 58fb3f96e43b18fdfe4fd1390e4575b4f4fed9cd239ed134c12365e4ae65001c · Zeichen 1158–1279 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-086893 · Präparat HOS-083385
Tabulated list of adverse reactions
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); uncommon (≥ 1/1,000 to < 1/100), not known (cannot
be estimated from the available data). The table lists adverse reactions reported in the clinical trials of
previously treated patients and identified in postmarketing use. The frequencies are based on all
causality treatment emergent adverse events in pooled clinical trials with 224 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage df7284c2532d12fec1f38c15d78415de0d8a16fde586bf22517f1942114c6d03 · Zeichen 1281–1896 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-086894 · Präparat HOS-083385
Within each frequency grouping, adverse reactions 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 225a4634b19bb56f8b8816ab0dcffe9b7b555a1be948fa1111cdf4b754be6cfa · Zeichen 1898–1997 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8
HOS-086895 · Präparat HOS-083385
7
System organ class Very Common Uncommon Frequency
common ≥ 1/100 ≥ 1/1,000 to not known
≥ 1/10 to < 1/10 < 1/100 (cannot be
estimated from
the available data)
Infections and Infusion-site
infestations cellulitisa
Blood and lymphatic Factor IX
system disorders inhibitionb
Immune system Hypersensitivityc Anaphylactic
disorders reaction*
Nervous system Headached Dizziness; Somnolence;
disorders Dysgeusia tremor
Eye disorders Visual
impairmente
Cardiac disorders Tachycardiaf
Vascular disorders Phlebitis; Hypotensionh Superior vena cava
flushingg syndromei,* ;
deep vein
thrombosis*;
thrombosis*;
thrombophlebitis*
Respiratory, thoracic Coughj
and mediastinal
disorders
Gastrointestinal Vomiting; nausea
disorders
Skin and subcutaneous Rashk; urticaria
tissue disorders
Renal and urinary Renal infarctl
disorders
General disorders and Pyrexia Chest discomforto; Inadequate therapeutic
administration site infusion-site response*
conditions reactionn;
infusion-site painm
Investigations Inadequate factor IX
recovery p, *
* ADR identified post-marketing
a
including cellulitis
b
low-titer transient inhibitor formation
c
including drug hypersensitivity, angioedema, bronchospasm, wheezing, dyspnoea, and laryngospasm
d
including migraine, sinus headache
e
including scintillating scotoma and blurred vision
f
including heart rate increased, sinus tachycardia
g
including hot flush, feeling hot, skin warm
h
including blood pressure decreased
i
superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion of BeneFIX
through a central venous catheter
j
including productive cough
k
including rash macular, rash papular, rash maculopapular
l
developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode.
m
including injection site pain, infusion-site discomfort
n
including infusion-site pruritus, infusion-site erythema
o
including chest pain and chest tightness
p
This is a verbatim term. No MedDRA 17.1 PT was retrieved.
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 4435ad2c953eba4e52144aa568fcac4d895caff3b4592b2c6d7c9c0ecc420bd8 · Zeichen 2055–5913 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8–9
HOS-086896 · Präparat HOS-083385
8
Description of selected 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 6f9d9b4d9284ed2014e6a1e9677436dcfc4f6148d7e50527d8bd6de50e0b81f6 · Zeichen 5968–6012 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9
HOS-086897 · Präparat HOS-083385
Hypersensitivity/allergic reactions
If any suspected hypersensitivity reaction takes place that is thought to be related to the administration
of BeneFIX see sections 4.2 and 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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 07916288419d0ca3b01ccc504defcf527eea47451e516ce886a7afb452a9ec83 · Zeichen 6014–6193 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9
HOS-086898 · Präparat HOS-083385
Inhibitor development
A clinically relevant, low responding inhibitor was detected in 1 out of 65 BeneFIX patients
(including 9 patients participating only in the surgery study) who had previously received plasma-
derived products. This patient was able to continue treatment with BeneFIX with no anamnestic rise in
inhibitor or anaphylaxis (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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage a1818cc3c8076c6a5904a4924aa1e8ea568582f414e2fed64157a4508c194fb4 · Zeichen 6195–6554 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9
HOS-086899 · Präparat HOS-083385
Paediatric population
Allergic reactions might be experienced more frequently in children than in adults.
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage f2a70e2b741574a37865c66ec2da713961f31a37fca5ea1d482a30319ac3badc · Zeichen 6556–6661 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9
HOS-086900 · Präparat HOS-083385
There are insufficient data to provide information on inhibitor incidence in PUPs (see also
section 5.1).
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 8d3a80aa0da774274ace572e30e36dab63363013ca15b69e203f72e1cd770ec7 · Zeichen 6663–6768 im Abschnitt
Nebenwirkungen · BeneFIX
BeneFIX 250 IU powder and solvent for solution for injection BeneFIX 500 IU powder and solvent for solution for injection BeneFIX 1000 IU powder and solvent for solution for injection BeneFIX 1500 IU powder and solvent for solution for injection BeneFIX 2000 IU powder and solvent for solution for injection BeneFIX 3000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9
HOS-086901 · Präparat HOS-083385
Reporting of suspected adverse reactions
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 2025-03-07T10:33:00Z · SHA-256 32f21758f2a70ebcdb4270dc878969f45b1067fad6cafd8c9319175576981935 · Passage 42f7144177697b690f59b1bda795c3fd216297691cf296a2e1269a137feab3cd · Zeichen 6770–7125 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.