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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.

RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.

Glivec

HOS-093339 · Fachinformation

Quellenpassagen (37)

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-110244 · Präparat HOS-093339

Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequency categories are defined using 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).

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 82e8b47a0e828dab7894366337d3064cb7e1dcaa924e47969b8164b35f49362b · Zeichen 2853–3220 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-110245 · Präparat HOS-093339

Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 4d63c8672ddb9a56c21c77edbc0b69e3f206dc86c95ac9c61fae5e77cf1b94f6 · Zeichen 3222–3335 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-110246 · Präparat HOS-093339

Adverse reactions and their frequencies are reported in Table 1.

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage b872c194dda4b7e36330bece1ac1c05919c3ff1a4a8985f789722114284f9c62 · Zeichen 3337–3401 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-110247 · Präparat HOS-093339

Table 1 Tabulated summary of adverse reactions

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage fb90f0426fcf0ccdc535c8907b8bcae8261630c79f053a46852281c186130233 · Zeichen 3403–3454 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13

HOS-110248 · Präparat HOS-093339

Infections and infestations Uncommon: Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis Rare: Fungal infection Not known: Hepatitis B reactivation* Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rare: Tumour lysis syndrome Not known: Tumour haemorrhage/tumour necrosis* Immune system disorders Not known: Anaphylactic shock* Blood and lymphatic system disorders Very common: Neutropenia, thrombocytopenia, anaemia Common: Pancytopenia, febrile neutropenia Uncommon: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy Rare: Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common: Anorexia Uncommon: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia Rare: Hyperkalaemia, hypomagnesaemia Psychiatric disorders Common: Insomnia Uncommon: Depression, libido decreased, anxiety Rare: Confusional state

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 4edfbeab97f404b21b1570583885e676f8bdcfb2be00dfab9b9232d98cd15c04 · Zeichen 3457–4984 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 13–14

HOS-110249 · Präparat HOS-093339

13 Nervous system disorders Very common: Headache2 Common: Dizziness, paraesthesia, taste disturbance, hypoaesthesia Uncommon: Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage Rare: Increased intracranial pressure, convulsions, optic neuritis Not known: Cerebral oedema* Eye disorders Common: Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision Uncommon: Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema Rare: Cataract, glaucoma, papilloedema Not known: Vitreous haemorrhage* Ear and labyrinth disorders Uncommon: Vertigo, tinnitus, hearing loss Cardiac disorders Uncommon: Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema Rare: Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion Not known: Pericarditis*, cardiac tamponade* Vascular disorders4 Common: Flushing, haemorrhage Uncommon: Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud’s phenomenon Not known: Thrombosis/embolism* Respiratory, thoracic and mediastinal disorders Common: Dyspnoea, epistaxis, cough Uncommon: Pleural effusion5, pharyngolaryngeal pain, pharyngitis Rare: Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage Not known: Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6 Common: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis Uncommon: Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis Rare: Colitis, ileus, inflammatory bowel disease Not known: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common: Increased hepatic enzymes Uncommon: Hyperbilirubinaemia, hepatitis, jaundice Rare: Hepatic failure8, hepatic necrosis

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 5c5d45f592c61865e7cb1d9875a37a4bd4d6959e1263338a9cc9c49094708ab2 · Zeichen 5039–7908 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 14–15

HOS-110250 · Präparat HOS-093339

14 Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash Common: Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction Uncommon: Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions, panniculitis12 Rare: Acute febrile neutrophilic dermatosis (Sweet’s syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP), pemphigus* Not known: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10 Common: Joint swelling Uncommon: Joint and muscle stiffness, osteonecrosis* Rare: Muscular weakness, arthritis, rhabdomyolysis/myopathy Not known: Growth retardation in children* Renal and urinary disorders Uncommon: Renal pain, haematuria, renal failure acute, urinary frequency increased Not known: Renal failure chronic Reproductive system and breast disorders Uncommon: Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema Rare: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administration site conditions Very common: Fluid retention and oedema, fatigue Common: Weakness, pyrexia, anasarca, chills, rigors Uncommon: Chest pain, malaise

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 28db5e0a1e9b279285fe74c19bb0b2d0c387be0c38b3327b7bd95ce6f8571d8e · Zeichen 7961–10297 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 15–16

HOS-110251 · Präparat HOS-093339

15 Investigations Very common: Weight increased Common: Weight decreased Uncommon: Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased Rare: Blood amylase increased * These types of reactions have been reported mainly from post-marketing experience with Glivec. This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications. Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to imatinib exposure. 1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST. 2 Headache was the most common in GIST patients. 3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML. 4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC). 5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML. 6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients. 8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported. 9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post- marketing. 10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients. 11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions. 12 Including erythema nodosum.

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 4f887aba22cd108a4a423bffbf878ca743d74855228992ca535580c28cded03e · Zeichen 10349–12660 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-110252 · Präparat HOS-093339

Laboratory test abnormalities

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 8dcdd9bd41448c072952c1dfcf67db2d4b043a74fd08b1128a1351c38bb24094 · Zeichen 12662–12691 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-110253 · Präparat HOS-093339

Haematology In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses  750 mg (phase I study). However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/l) and thrombocytopenias (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59–64% and 44–63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia). In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/l) and thrombocytopenia (platelet count < 10 x 109/l) were observed in 3.6% and < 1% of patients, respectively. The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively. These events can usually be managed with either a reduction of the dose or an interruption of treatment with Glivec, but can in rare cases lead to permanent discontinuation of treatment. In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia. These generally occur within the first several months of therapy.

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 5dffae505d06c0274cae8c0e79331dd87cdfb68bd7dc40ae916ef00899587bd5 · Zeichen 12693–14087 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16

HOS-110254 · Präparat HOS-093339

In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intra- tumoural bleeding in at least some of these patients. Grade 3 and 4 neutropenia was seen in 7.5% and 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients. No patient developed grade 4 thrombocytopenia. The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 76578d81a6785685345c50d779b91f235012d8a141556fbc95b3dbe3dc055983 · Zeichen 14089–14689 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 16–17

HOS-110255 · Präparat HOS-093339

16 Biochemistry Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week). Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1% of CML patients. In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed. Bilirubin elevation was below 3%.

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 797b948e6041bb416d474a3292fe2802d07f0e6ed6ca164a1778a659366bc962 · Zeichen 14748–15303 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-110256 · Präparat HOS-093339

There have been cases of cytolytic and cholestatic hepatitis and hepatic failure; in some of them outcome was fatal, including one patient on high dose paracetamol.

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage ceb49777536c90e3f9f7a035568ddf80f8be5e77e88ef1216c0e3457468b8e57 · Zeichen 15305–15469 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-110257 · Präparat HOS-093339

Description of selected adverse reactions

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage f66db2a8100a521c1dea72ff90e696fa3846f9d5fcd6cf8e5e03ce5d71bde4a7 · Zeichen 15471–15512 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-110258 · Präparat HOS-093339

Hepatitis B reactivation Hepatitis B reactivation has been reported in association with BCR-ABL TKIs. Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome (see section 4.4).

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

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 9d4ba8f350486fc1e3f7a79431c0401477715afc19f4d1e97f06e2f022c27ca5 · Zeichen 15514–15754 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-110259 · Präparat HOS-093339

Reporting of suspected adverse reactions

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 822da43363cee11e87abeb55cf82453415269315377df150bb5de7dde8dd938f · Zeichen 15756–15796 im Abschnitt

Nebenwirkungen · Glivec

Glivec 100 mg film-coated tablets Glivec 400 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 17

HOS-110260 · Präparat HOS-093339

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.

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Version 2025-11-12T09:28:00Z · SHA-256 838bc114dc50fcc5141e52ce7cbac64366b6fd4a03bb5a5e7a5ec09cf8be0b00 · Passage 74a0f950f48fc319c58a44d53b75de3b0b1b2c9d2aeabe3a4978a08e017e0e18 · Zeichen 15798–16113 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.