Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Hetronifly

HETRONIFLY 10 mg/ml concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 13–14

HOS-151884 · Präparat HOS-100641

* Adverse reaction frequencies presented in Table 2 may not be fully attributable to serplulimab alone but may contain contributions from the underlying disease or from other medicinal products used in a combination. The following terms represent a group of related events that describe a medical condition rather than a single event: a. Includes pneumonia, lung abscess. b. Includes urinary tract infection, asymptomatic bacteriuria, white blood cells urine positive. c. Includes upper respiratory tract infection, pharyngotonsillitis, tonsillitis, influenza-like illness, lower respiratory tract infection. d. Includes activated partial thromboplastin time prolonged, activated partial thromboplastin time, activated partial thromboplastin time shortened, international normalised ratio decreased, prothrombin level increased, coagulopathy, hypercoagulation. e. Includes drug hypersensitivity, infusion-related reaction. f. Includes hypothyroidism, blood thyroid stimulating hormone increased, thyroxine free decreased, thyroxine decreased, central hypothyroidism, tri-iodothyronine decreased, tri- iodothyronine free decreased, immune-mediated hypothyroidism. g. Includes hyperthyroidism, blood thyroid stimulating hormone decreased, thyroxine increased, tri-iodothyronine increased, tri-iodothyronine free increased, thyroxine free increased, immune- mediated hyperthyroidism. h. Includes hyperglycaemia, type 1 diabetes mellitus, blood glucose increased, type 2 diabetes mellitus, impaired fasting glucose, diabetic ketoacidosis, blood ketone body increased, glucose tolerance impaired, ketoacidosis, glycosuria. i. Includes thyroid disorder, thyroiditis. j. Includes adrenal insufficiency, cortisol decreased. k. Includes euthyroid sick syndrome, ultrasound thyroid abnormal. l. Includes anti-thyroid antibody positive, thyroglobulin increased. m. Includes hyponatraemia, hypocalcaemia, hypokalaemia, hypomagnesaemia, hypophosphataemia, hypochloraemia, hyperphosphataemia, hyperkalaemia, hypermagnesaemia, hypercalcaemia. n. Includes neuropathy peripheral, peripheral sensorimotor neuropathy, immune-mediated neuropathy. o. Includes immune-mediated encephalitis, encephalitis autoimmune. p. Includes supraventricular extrasystoles, supraventricular tachycardia, arrhythmia, ventricular extrasystoles, arrhythmia supraventricular, atrial fibrillation, atrial tachycardia, bradyarrhythmia, early repolarisation syndrome, ventricular arrhythmia, palpitations, electrocardiogram abnormal. q. Includes atrioventricular block first degree, bundle branch block right, atrial conduction time prolongation, bundle branch block left, defect conduction intraventricular. r. Includes cardiac failure, cardiac failure acute, left ventricular failure, cardiopulmonary failure, N terminal prohormone brain natriuretic peptide increased. s. Includes immune-mediated lung disease, pneumonitis, interstitial lung disease. t. Includes acquired trachea-oesophageal fistula, gastrointestinal haemorrhage, gastrointestinal disorder, intestinal obstruction. u. Includes enteritis, enteritis infectious, immune-mediated enterocolitis, colitis, colitis ulcerative, enterocolitis, duodenitis. v. Includes hepatic function abnormal, drug-induced liver injury, liver injury, immune-mediated hepatitis, immune-mediated hepatic disorder **, hepatic failure **. w. Includes rash, rash maculo-papular, eczema, drug eruption, erythema, skin toxicity, palmar- plantar erythrodysaesthesia syndrome. x. Includes autoimmune dermatitis, dermatitis, dermatitis allergic, dermatitis bullous, seborrhoeic dermatitis. 13  y. Includes myositis **, immune-mediated myositis. z. Includes acute kidney injury, renal failure, renal impairment, renal injury, chronic kidney disease, creatinine renal clearance decreased, immune-mediated nephritis. ** Post-marketing event.

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