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.
All patients received adequate supplementation with vitamin D and calcium in the post-menopausal
osteoporosis trial, the prevention of clinical fractures after hip fracture trial, and the Paget’s disease
trials (see also section 4.2). In the trial for the prevention of clinical fractures following a recent hip
fracture, vitamin D levels were not routinely measured but the majority of patients received a loading
dose of vitamin D prior to Aclasta administration (see section 4.2).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Local reactions
In a large clinical trial, local reactions at the infusion site, such as redness, swelling and/or pain, were
reported (0.7%) following the administration of zoledronic acid.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Osteonecrosis of the jaw
Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with
medicinal products that inhibit bone resorption, including zoledronic acid (see section 4.4). In a large
clinical trial in 7,736 patients, osteonecrosis of the jaw has been reported in one patient treated with
Aclasta and one patient treated with placebo. Cases of ONJ have been reported in the post-marketing
setting for Aclasta.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Acute phase reactions
The overall percentage of patients who reported acute phase reactions or post-dose symptoms
(including serious cases) after Aclasta administration is as follows (frequencies derived from the study
in treatment of post-menopausal osteoporosis): fever (18.1%), myalgia (9.4%), flu-like symptoms
(7.8%), arthralgia (6.8%) and headache (6.5%), the majority of which occurred within the first 3 days
following Aclasta administration. The majority of these symptoms were mild to moderate in nature
and resolved within 3 days of the event onset. The incidence of these symptoms decreased with
subsequent annual doses of Aclasta. The percentage of patients who experienced adverse reactions
was lower in a smaller study (19.5%, 10.4%, 10.7% after the first, second and third infusion,
respectively), where prophylaxis against adverse reactions was used (see section 4.4).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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.
Version 2026-04-20T10:47:00Z · SHA-256 89925fa2be82f6d5a29064dd0533752115b4e428209688a5d66e6d16a03ab439 · Passage 591ce3aa6d6555db7032d0551da929e990b92080da2928085827a75c666ec353 · Zeichen 12254–12568 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.