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 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Gegenanzeigen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 5
HOS-112435 · Präparat HOS-093675
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 8cc0fe29768569a55e0703c8413d5a145077448bca5f7426ab9084406d167fa6 · Zeichen 0–91 im Abschnitt
Gegenanzeigen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 5
HOS-112436 · Präparat HOS-093675
Known allergic reaction to mouse or 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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 6770d0a4bbbd88cf8745d32aaf865bf523ba9c76086d92008a541b8d80594736 · Zeichen 93–145 im Abschnitt
Gegenanzeigen · Advate
ADVATE 250 IU/2 ml powder and solvent for solution for injection ADVATE 500 IU/2 ml powder and solvent for solution for injection ADVATE 1 000 IU/2 ml powder and solvent for solution for injection ADVATE 1 500 IU/2 ml powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 18
HOS-112457 · Präparat HOS-093675
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 8cc0fe29768569a55e0703c8413d5a145077448bca5f7426ab9084406d167fa6 · Zeichen 0–91 im Abschnitt
Gegenanzeigen · Advate
ADVATE 250 IU/2 ml powder and solvent for solution for injection ADVATE 500 IU/2 ml powder and solvent for solution for injection ADVATE 1 000 IU/2 ml powder and solvent for solution for injection ADVATE 1 500 IU/2 ml powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 18
HOS-112458 · Präparat HOS-093675
Known allergic reaction to mouse or 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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 6770d0a4bbbd88cf8745d32aaf865bf523ba9c76086d92008a541b8d80594736 · Zeichen 93–145 im Abschnitt
Wechselwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 6
HOS-112437 · Präparat HOS-093675
No interactions of human coagulation factor VIII (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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 2a2eff7d01430a4c979063ae150d24e7951c7e39bf23a3a96f30b9b644e7ad1e · Zeichen 0–114 im Abschnitt
Wechselwirkungen · Advate
ADVATE 250 IU/2 ml powder and solvent for solution for injection ADVATE 500 IU/2 ml powder and solvent for solution for injection ADVATE 1 000 IU/2 ml powder and solvent for solution for injection ADVATE 1 500 IU/2 ml powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 19
HOS-112459 · Präparat HOS-093675
No interactions of human coagulation factor VIII (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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 2a2eff7d01430a4c979063ae150d24e7951c7e39bf23a3a96f30b9b644e7ad1e · Zeichen 0–114 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6
HOS-112438 · Präparat HOS-093675
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage d55a523b6a19085dba8d780d613791739571d7f51eec366b153cafd8949337ee · Zeichen 0–29 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6
HOS-112439 · Präparat HOS-093675
Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE
reporting in total 93 adverse drug reactions (ADRs). The ADRs that occurred in the highest frequency
were development of neutralising antibodies to factor VIII (inhibitors), headache and fever.
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 027fd64f714d01399084c334bd38395573b83bc8fbec98e49163a4ca15b5e10b · Zeichen 31–312 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6
HOS-112440 · Präparat HOS-093675
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
rarely and may in some cases progress to severe anaphylaxis (including shock).
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 7d6a609bd724d3a05a27d6669707425305daa275a404ef9a2e1d0af3b72ecde4 · Zeichen 314–694 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6
HOS-112441 · Präparat HOS-093675
Development of antibodies to mouse and/or hamster protein with related hypersensitivity reactions
may be 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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage dace2748f004014fdc8698ddd56b646a200b945f3a24eebc51dca42f5da3048d · Zeichen 696–810 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6
HOS-112442 · Präparat HOS-093675
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated
with factor VIII, including with ADVATE (see section 5.1). 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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage f06b45045f417730383e320dc0593e627bcd4f8e9122ba4859504fa5a07527e9 · Zeichen 812–1155 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 6–7
HOS-112443 · Präparat HOS-093675
6
Tabulated summary 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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 43c32ab6960cf66f4ff64f8c90bcd91247db63d59f6f6d034283eebe43334673 · Zeichen 1210–1251 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-112444 · Präparat HOS-093675
Table 2 provides the frequency of adverse reactions in clinical trials and from spontaneous reporting,
according to the MedDRA system organ classification (SOC and Preferred Term Level).
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 7b23477229267b5d6a8ca6aa28c1a2d000ee1d66b587e09e7e2c05a35297e6da · Zeichen 1253–1439 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-112445 · Präparat HOS-093675
Frequency has been evaluated according to 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). 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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage e256d0029b50dab9ea66ee1bbc37e28c307b0d5a224eb2b502a1fc15da29bf16 · Zeichen 1441–1804 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7
HOS-112446 · Präparat HOS-093675
Table 2. Frequency of adverse reactions in clinical trials and from spontaneous reports
MedDRA Standard System Organ Class Adverse reaction Frequencya
Infections and infestations Influenza Uncommon
Laryngitis Uncommon
Blood and lymphatic system disorders Factor VIII inhibition Uncommon (PTPs)b
Very common (PUPs)b
Lymphangitis Uncommon
Immune system disorders Anaphylactic reaction* Not known
Hypersensitivityc* Not known
Nervous system disorders Headache Common
Dizziness Uncommon
Memory impairment Uncommon
Syncope Uncommon
Tremor Uncommon
Migraine Uncommon
Dysgeusia Uncommon
Eye disorders Eye inflammation Uncommon
Cardiac disorders Palpitations Uncommon
Vascular disorders Haematoma Uncommon
Hot flush Uncommon
Pallor Uncommon
Respiratory, thoracic and mediastinal disorders Dyspnoea Uncommon
Gastrointestinal disorders Diarrhoea Uncommon
Abdominal pain upper Uncommon
Nausea Uncommon
Vomiting Uncommon
Skin and subcutaneous tissue disorders Pruritus Uncommon
Rash Uncommon
Hyperhidrosis Uncommon
Urticaria Uncommon
General disorders and administration site Pyrexia Common
conditions Peripheral oedema Uncommon
Chest pain Uncommon
Chest discomfort Uncommon
Chills Uncommon
Feeling abnormal Uncommon
Vessel puncture site haematoma Uncommon
Fatigue* Not known
Injection site reaction* Not known
Malaise* Not known
Investigations Monocyte count increased Uncommon
Coagulation factor VIII level Uncommon
decreasedd
Haematocrit decreased Uncommon
Laboratory test abnormal Uncommon
Injury, poisoning and procedural complications Post-procedural complication Uncommon
Post-procedural haemorrhage Uncommon
Procedural site reaction Uncommon
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage f70966a0b4bf42c80e52ec4e1ba2441c49bcd2c2a1289dbdfa1f1ff03280c074 · Zeichen 1806–6429 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8
HOS-112447 · Präparat HOS-093675
7
a) Calculated based on total number of patients who received ADVATE (418) in clinical trials,
except for adverse reactions identified in post-marketing surveillance marked with *.
b) Frequency is based on studies with all FVIII products which included patients with severe
haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
c) ADR explained in the section below.
d) The unexpected decrease in coagulation factor VIII levels occurred in one patient during
continuous infusion of ADVATE following surgery (post-operative days 10-14). Haemostasis
was maintained at all times during this period and both plasma factor VIII levels and clearance
rates returned to appropriate levels by post-operative day 15. Factor VIII inhibitor assays
performed after completion of continuous infusion and at study termination were negative.
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 518bff6d1346bef0e64f786a60dc8806a1a778037a2bbdf9f1b1dd61d94b875f · Zeichen 6483–7393 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8
HOS-112448 · Präparat HOS-093675
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 7395–7436 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8
HOS-112449 · Präparat HOS-093675
ADRs specific to residues from the manufacturing process
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage d399f257741ee84f54e16ddaa9b2908f675762039435b1431710968981baa9f7 · Zeichen 7438–7494 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8
HOS-112450 · Präparat HOS-093675
Of the 229 treated patients who were assessed for antibodies to Chinese hamster ovary (CHO) cell
protein, 3 showed a statistically significant upward trend in titres, 4 displayed sustained peaks or
transient spikes and one patient had both but no clinical symptoms. Of the 229 treated patients who
were assessed for antibodies to murine IgG, 10 showed a statistically significant upward trend,
2 displayed a sustained peak or transient spike and one patient had both. Four of these patients
reported isolated events of urticaria, pruritus, rash, and slightly elevated eosinophil counts amongst
repeated exposures to the study product.
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage b955fdadfdf9b53b0823166cb81819ad4d68def6da94f0d2a5ae9fb5e9d727f0 · Zeichen 7496–8130 im Abschnitt
Nebenwirkungen · Advate
ADVATE 250 IU/5 ml powder and solvent for solution for injection ADVATE 500 IU/5 ml powder and solvent for solution for injection ADVATE 1 000 IU/5 ml powder and solvent for solution for injection ADVATE 1 500 IU/5 ml powder and solvent for solution for injection ADVATE 2 000 IU/5 ml powder and solvent for solution for injection ADVATE 3 000 IU/5 ml powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8
HOS-112451 · Präparat HOS-093675
Hypersensitivity
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 2025-05-23T12:20:00Z · SHA-256 1676714d819bb0bd275e9f7e4eb6349a64035cde34acd2a9aa639c8e0ad4123b · Passage 8aa838745d28f3ccd917c1e55deb54419109238db243009acd11924d9d2af36a · Zeichen 8132–8148 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.