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Aclasta · 4.8 · Atrial fibrillation In the HORIZON – Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of
Eintrag öffnenAclasta · 4.8 · Based on laboratory assessment, transient asymptomatic calcium levels below the normal reference range (less t
Eintrag öffnenAclasta · 4.8 · Description of selected adverse reactions
Eintrag öffnenAclasta · 4.8 · Hypocalcaemia In clinical trials in osteoporosis, approximately 0.2% of patients had notable declines of serum
Eintrag öffnenAclasta · 4.8 · In clinical trials in osteoporosis, the change in creatinine clearance (measured annually prior to dosing) and
Eintrag öffnenAclasta · 4.8 · In the Paget’s disease trials, symptomatic hypocalcaemia was observed in approximately 1% of patients, in all
Eintrag öffnenAclasta · 4.8 · Infections and infestations Uncommon Influenza, nasopharyngitis Blood and lymphatic system disorders Uncommon
Eintrag öffnenAclasta · 4.8 · Local reactions In a large clinical trial, local reactions at the infusion site, such as redness, swelling and
Eintrag öffnenAclasta · 4.8 · Osteonecrosis of the jaw Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patient
Eintrag öffnenAclasta · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenAclasta · 4.8 · Summary of the safety profile
Eintrag öffnenAclasta · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenAclasta · 4.8 · The overall percentage of patients who experienced adverse reactions were 44.7%, 16.7% and 10.2% after the fir
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