natgillin/translations-raw huggingface dataset:
Patienter med mild eller moderat nyreinsufficiens (kreatinin- clearance = 20- 59 ml/ min) bør gives den minimale anbefalede dosis på 400 mg dagligt som startdosis.
Patients with mild or moderate renal dysfunction (creatinine clearance = 20– 59 ml/ min) should be given the minimum recommended dose of 400 mg daily as starting dose.
Selvom kun meget begrænset information er tilgængelig, kan patienter med alvorlig nyreinsufficiens (kreatinin- clearance = < 20 ml/ min) eller i dialyse også starte på same dosis på 400 mg.
Although very limited information is available, patients with severe renal dysfunction (creatinine clearance = < 20 ml/ min) or on dialysis could also start at the same dose of 400 mg.
4. 4 og 5. 2).
The dose can be reduced if not tolerated, or increased for lack of efficacy (see sections 4.4 and 5.2).
Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
Imatinib pharmacokinetics have not been specifically studied in the elderly.
Specifik dosisjustering er ikke nødvendig til ældre patienter.
No specific dose recommendation is necessary in the elderly.
4. 5).
When Glivec is co-administered with other medicinal products, there is a potential for drug interactions (see section 4.5).
Samtidig anvendelse af stærke CYP3A4 induktorer og imatinib bør
Concomitant use of imatinib and medicinal products that induce CYP3A4 (e. g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St.
4. 5).
Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
4. 5).
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Glivec (see section 4.5).
TSH niveauer bør følges nøje hos sådanne patienter.
TSH levels should be closely monitored in such patients.
4. 2, 4. 8 og 5. 2).
In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see sections 4.2, 4.8 and 5.2).
Det bør bemærkes, at GIST- patienter kan have levermetastaser, hvilket kan medføre leverinsufficiens.
It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
4. 5 og 4. 8).
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).
2, 5% af nyligt diagnosticerede CML- patienter i behandling med Glivec er der rapporteret tilfælde af svær væskeretention (pleuraeksudat, ødem, pulmonært ødem, ascites, perifert ødem).
Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec.
Patienter med hjertesygdom, eller som har risikofaktorer for hjertesvigt, bør monitores omhyggeligt, og alle patienter, som har symptomer forenelige med hjertesvigt bør undersøges og behandles.
Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.
Initiering af imatinibterapi har i isolerede tilfælde været forbundet med carcinogent chok/ dysfunktion af venstre ventrikel hos patienter med hypereosinofilt syndrom (HES) og hjertepåvirkning.
In patients with hypereosinophilic syndrome (HES) and cardiac involvement, isolated cases of cardiogenic shock/ left ventricular dysfunction have been associated with the initiation of imatinib therapy.
Da der er rapporteret tilfælde af hjertebivirkninger med imatinib, bør der foretages en nøje benefit/ risk- vurdering hos HES/ CEL- populationen før påbegyndelse af behandling.
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/ risk of imatinib therapy should be considered in the HES/ CEL population before treatment initiation.
Myelodysplastiske/ myeloproliferative sygdomme med PDGFR- omlejring kan være forbundet med høje eosinofiltal.
Myelodysplastic/ myeloproliferative diseases with PDGFR gene re-arrangements could be associated with high eosinophil levels.
Undersøgelse hos en kardiolog, optagelse af ekkokardiogram og bestemmelse af serumtroponin bør derfor overvejes hos patienter med MDS/ MPD, som har høje eosinofiltal, før der gives imatinib.
Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/ CEL, and in patients with MDS/ MPD associated with high eosinophil levels before imatinib is administered.
Hvis en af disse undersøgelser viser abnormalitet, bør det overvejes at kombinere imatinib med profylaktisk brug af systemisk steroid (1- 2 mg/ kg) i en til to uger ved behandlingsstart.
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1– 2 mg/ kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
I den kliniske undersøgelse med GIST- patienter rapporteredes både gastrointestinale og intra- tumorale blødninger (se pkt.
In the GIST clinical trial, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
Der er, baseret på tilgængelige data, ikke identificeret disponerende faktorer (for eksempel tumorstørrelse, tumorplacering, koagulationsforstyrrelser), der kan placere GIST - patienter i en højere risikogruppe for nogen af blødningstyperne.
Based on the available data, no predisposing factors (e. g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
Da øget vaskularisering og blødningstendens er en del af det kliniske billede ved GIST, bør der hos alle patienter anvendes standardtiltag og - procedurer for monitorering og behandling af blødning.
Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Fuldstændige blodtællinger skal foretages jævnligt under behandling med Glivec.
Laboratory tests Complete blood counts must be performed regularly during therapy with Glivec.
Behandling af CML- patienter med Glivec har været associeret med neutropeni eller thrombocytopeni.
Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia.
4. 2.
Treatment with Glivec may be interrupted or the dose may be reduced, as
Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter i Glivec- behandling.
7 recommended in section 4.2.
Plasmaeksponeringen synes at være højere hos patienter med nedsat nyrefunktion end hos patienter med normal nyrefunktion, formentlig på grund af forhøjede plasmaniveauer af alpha- acid glucoprotein
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Glivec.
7 (AGP), et imatinib- bindende protein, hos disse patienter.
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
4. 2 og 5. 2).
The dose can be reduced if not tolerated (see section 4.2 and 5.2).
Stoffer der hæmmer cytochrom P450 isoenzym CYP3A4- aktivitet (f. eks. ketoconazol, itraconazol, erythromycin, clarithromycin) kan nedsætte metabolismen og øge koncentrationen af imatinib.
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e. g. ketoconazole, itraconazole, erythromycin, clarithromycin) could decrease metabolism and increase imatinib concentrations.
Der sås signifikant øgning i følsomhed for imatinib (gennemsnitlig Cmax og AUC for imatinib steg med henholdsvis 26% og 40%) hos raske frivillige ved samtidig administration af enkeltdosis ketoconazol (en CYP3A4- hæmmer).
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Forsigtighed bør udvises, når Glivec administreres sammen med hæmmere af CYP3A4- familien.
Caution should be taken when administering Glivec with inhibitors of the CYP3A4 family.
Stoffer, der inducerer CYP3A4- aktivitet, kan øge metabolismen og reducere plasmakoncentrationen af imatinib.
Substances that are inducers of CYP3A4 activity could increase metabolism and decrease imatinib plasma concentrations.
Samtidig behandling med CYP3A4- inducerende stoffer (f. eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon eller Hypericum perforatum, også kendt som prikbladet perikum) kan signifikant reducere følsomheden overfor Glivec, og dermed potentielt øge risikoen for terapeutisk svigt.
John’ s Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.
Præbehandling med gentagne doser af rifampicin 600 mg efterfulgt af enkeltdosis Glivec 400 mg resulterede i fald i Cmax og AUC( 0- ∞) på mindst 54% og 74% af værdierne uden rifampicinbehandling.
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of Glivec resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med Glivec samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin.
Similar results were observed in patients with malignant gliomas treated with Glivec while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbamazepine and phenytoin.
Samtidig anvendelse af rifampicin eller andre stærke CYP3A4 induktorer og imatinib bør undgås.
Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Aktive stoffer hvis plasmakoncentration kan ændres af imatinib Imatinib øger gennemsnitligt Cmax og AUC af simvastatin (et CYP3A4 substrat) henholdsvis 2 og 3, 5 gange, hvilket indikerer, at imatinib hæmmer CYP3A4.
Active substances that may have their plasma concentration altered by Glivec Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Forsigtighed tilrådes derfor, når Glivec administreres sammen med CYP3A4- substrater med snævert terapeutisk interval (f. eks. ciclosporin eller pimozid).
Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e. g. cyclosporin or pimozide).
Glivec kan øge plasmakoncentrationen af andre CYP3A4- metaboliserede lægemidler (for eksempel triazolo- benzodiazepiner, dihydropyridin calciumkanalblokkere, visse HMG- CoA reduktasehæmmere, såsom statiner o. s. v.).
Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e. g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i. e. statins, etc.).
Da warfarin metaboliseres via CYP2C9, bør patienter med behov for antikoagulantia have heparin med lav molekylevægt eller standardheparin.
Because warfarin is metabolised by CYP2C9, patients who require anticoagulation should receive low-molecular-weight or standard heparin.
In vitro hæmmer Glivec cytochrom P450 isoenzym CYP2D6- aktivitet ved koncentrationer svarende til dem, der påvirker CYP3A4- aktivitet.
In vitro Glivec inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
400 mg imatinib to gange daglig havde en inhibitorisk effekt på CYP2D6- medieret metoprololmetabolisme, som gav en stigning af Cmax og AUC for metoprolol på cirka 23% (90% CI [1, 16- 1, 30]).
Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Forsigtighed tilrådes dog ved CYP2D6- substrater med et snævert terapeutisk vindue som f. eks. metorpolol.
Dose adjustments do not seem to be necessary when imatinib is co-administrated with CYP2D6 substrates, however caution is advised for CYP2D6 substrates with a narrow therapeutic window such as metoprolol.
Hos patienter der behandles med metoprolol bør klinisk monitorering overvejes.
In patients treated with metoprolol clinical monitoring should be considered.
In vitro hæmmer Glivec O- glucuronidationen af paracetamol (Ki- værdi på 58, 5 mikromol/ L ved terapeutisk niveau).
In vitro, Glivec inhibits paracetamol O-glucuronidation (Ki value of 58.5 micromol/ l at therapeutic levels).
Der tilrådes forsigtighed, når Glivec anvendes sammen med paracetamol, især ved høje doser af paracetamol.
Caution should therefore be exercised when using Glivec and paracetamol concomitantly, especially
4. 4).
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when Glivec is co-administered (see section 4.4).
8 Der er klinisk erfaring med administration af Glivec sammen med kemoterapi til patienter med Ph+ ALL, men specifikke interaktionsstudier mellem imatinib og kemoterapiregimer er ikke tilstrækkeligt karakteriseret.
In Ph+ ALL patients, there is clinical experience of co-administering Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
4. 8).
Imatinib adverse events, i. e. hepatotoxicity, myelosuppression or others, may increase and it has been reported that concomitant use with L-asparaginase could be associated with increased hepatotoxicity (see section 4.8).
Der foreligger ikke tilstrækkelige data om brugen af imatinib hos gravide kvinder.
Pregnancy There are no adequate data on the use of imatinib in pregnant women.
Den potentielle risiko for fostret er ukendt.
Studies in animals have however shown reproductive toxicity (see section 5.3) and the potential risk for the foetus is unknown.
Glivec bør ikke anvendes under graviditet, med mindre det er klart nødvendigt.
Glivec should not be used during pregnancy unless clearly necessary.
Hvis Glivec anvendes under graviditet, bør patienten informeres om den potentielle risiko for fostret.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Kvinder i den fertile alder tilrådes at bruge effektiv antikonception under behandlingen.
Women of childbearing potential must be advised to use effective contraception during treatment.
Det vides ikke om imatinib udskilles i modermælk.
Lactation It is not known whether imatinib is excreted in human milk.
Imatinib og/ eller dets metabolitter udskilles i høj grad i modermælk hos dyr.
In animals, imatinib and/ or its metabolites were extensively excreted in milk.
Derfor bør kvinder, der anvender Glivec, ikke amme.
Women who are taking Glivec should therefore not breast-feed.
Dog bør patienter advares om, at de kan opleve bivirkninger, så som svimmelhed eller sløret syn, under behandling med imatinib.
However, patients should be advised that they may experience undesirable effects such as dizziness or blurred vision during treatment with imatinib.
I kliniske undersøgelser i CML blev der hos 2% af ny- dianogseret patienter, hos 2, 4% af patienterne i sen kronisk fase efter svigtende interferonbehandling, hos 4% af patienterne i accelereret fase efter svigtende interferonbehandling og hos 5% af patienterne i blastkrise efter svigtende interferonbehandling observeret seponering af undersøgelsesmedicinen på grund af lægemiddelrelaterede bivirkninger.
In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
Hos 4% af GIST patienterne blev undersøgelsesmedicinen seponeret på grund af lægemiddelrelaterede bivirkninger.
In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
Der sås hyppigere myelosuppression hos CML- patienter end hos GIST- patienter, hvilket sandsynligvis skyldes primærsygdommen.
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
I den kliniske undersøgelse med GIST- patienter, oplevede 7 (5%) af patienterne CTC grad 3– 4: gastrointestinale blødninger (3 patienter), intra- tumorale blødninger (3 patienter) eller begge dele (1 patient).
In the GIST clinical trial, 7 (5%) patients experienced CTC grade 3/ 4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
4. 4).
GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Når imatinib blev kombineret med højdosis kemoterapi hos Ph+ ALL patienter, sås forbigående levertoksicitet i form af forhøjet transaminase og hyperbilirubinæmi.
9 When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
9 Diverse bivirkninger, som for eksempel pleuraeksudat, ascites, lungeødem og hurtig vægtstigning med eller uden overfladiske ødemer, kan kollektivt betegnes som ” væskeretention ”.
Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “ fluid retention”.
I nogle tilfælde kan disse tilstande dog være alvorlige eller livstruende, og flere patienter med blastkrise døde med en kompleks anamnese af pleuraeksudat, kongestivt hjertesvigt og nyresvigt.
However, some of these reactions may be serious or life- threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Bivirkninger Bivirkninger rapporteret som mere end et isoleret tilfælde er listet nedenfor efter organklasse og hyppighed.
Adverse reactions Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Meget almindelig (> 1/ 10), almindelig (> 1/ 100 ≤1/ 10) og usædvanlig (> 1/ 1. 000 ≤1/ 100), sjælden (≤1/ 1. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (> 1/ 10), common (> 1/ 100, ≤ 1/ 10), uncommon (> 1/ 1,000, ≤ 1/ 100), rare (≤ 1/ 1,000), not known (cannot be estimated from the available data).
Indenfor hver frekvensgruppe er bivirkninger opstillet efter frekvens, med de hyppigste først.
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Bivirkninger og deres frekvens i Tabel 1 er baseret på de vigtigste registreringsstudier.
Adverse reactions and their frequencies reported in Table 1 are based on the main registration studies.
Bivirkninger i kliniske studier
Adverse reactions in clinical studies
Meget almindelig:
Investigations Very common:
Vægtstigning Vægttab Forhøjet alkalisk fosfatase, forhøjet kreatinin, øget serumkreatinfosfokinase og øget serumlactatdehydrogenase
Weight increased Weight decreased Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Hjertebanken, hjertesvigt1, lungeødem, tachykardi Arytmi, atrieflimren, hjertestop, myokardieinfarkt, angina pectoris, perikardielt ekssudat
Palpitations, tachycardia, cardiac failure congestive1, pulmonary oedema Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Neutropeni, thrombocytopeni, anæmi Pancytopeni, febril neutropeni Trombocytæmi, lymfopeni, knoglemarvsdepression, eosinofili, lymphadenopati Hæmolytisk anæmi
Neutropenia, thrombocytopenia, anaemia Pancytopenia, febrile neutropenia Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Meget almindelig:
Nervous system disorders Very common:
Hovedpine2 Svimmelhed, paræstesi, smagsforstyrrelser, hypoæstesi Migræne, somnolens, synkope, perifer neuropati, hukommelsessvigt, iskias, restless leg syndrome, tremor, hjerneblødning
Headache2 Dizziness, paraesthesia, taste disturbance, hypoaesthesia Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Ikke almindelig:
Ear and labyrinth disorders Uncommon:
Luftveje, thorax og mediastinum Almindelig:
Respiratory, thoracic and mediastinal disorders
Dyspnø, næseblod, hoste Pleuraekssudat3, faryngolaryngeale smerter, pharyngitis Pleuralgi, pulmonær fibrose, pulmonær hypertension, pulmonær blødning
Dyspnoea, epistaxis, cough Pleural effusion3, pharyngolaryngeal pain, pharyngitis Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Meget almindelig:
Gastrointestinal disorders Very common:
Kvalme, diarré, opkast, dyspepsi, abdominalsmerter4 Flatulens, abdominal udspilling, gastrooesophageal refluks, obstipation, mundtørhed, gastritis
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain4 Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Stomatitis, mundulcera, gastrointestinalblødning5, sure opstød, melæna, betændelse i spiserøret, ascites, mavesår, hæmatemese, cheilitis, dysfagi, pankreatitis
Stomatitis, mouth ulceration, gastrointestinal haemorrhage5, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Hud og subkutane væv
Renal and urinary disorders Uncommon:
Meget almindelig:
Skin and subcutaneous tissue disorders Very common:
Periorbitalt ødem, dermatitis/ eksem/ udslæt Pruritus, ansigtsødem, tør hud, erythem, alopeci, natlig svedtendens, lysoverfølsomhedsreaktion
Periorbital oedema, dermatitis/ eczema/ rash Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Akut febril neutrofil dermatose (Sweets syndrom), misfarvning af negle, angioødem, vesikulært udslæt, erythema multiforme, leukocytoklastisk vasculitis, Stevens- Johnson syndrom
Acute febrile neutrophilic dermatosis (Sweet’ s syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome
Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi, artralgi, knoglesmerter
Muscle spasm and cramps, musculoskeletal pain including myalgia, arthralgia, bone pain6
Metabolisme og ernæring Almindelig:
Metabolism and nutrition Common:
Anoreksi Hypokaliæmi, øget appetit, hypofosfatæmi, nedsat appetit, dehydrering, gigt, hyperuricæmi, hyperkalcæmi, hyperglykæmi, hyponatriæmi
Joint swelling Joint and muscle stiffness Muscular weakness, arthritis disorders Anorexia Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Hyperkaliæmi, hypermagnesiæmi
Hyperkalaemia, hypomagnesaemia
Herpes zoster, herpes simplex, næsesvælgsrumskatar, pneumoni7, bihulebetændelse, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia7, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Vaskulære sygdomme8
Vascular disorders8
Rødmen, blødning Hypertension, hæmatom, kuldefornemmelser i ekstremiteter, hypotension, Raynaud’ s syndrom
Flushing, haemorrhage Hypertension, haematoma, peripheral coldness, hypotension, Raynaud’ s phenomenon
Lever og galdevej
Hepatobiliary disorders
Væskeretention og ødem, træthed Svaghed, pyrexia, anasarka, kuldegysninger og kulderystelser Brystsmerter, utilpashed
Fluid retention and oedema, fatigue Weakness, pyrexia, anasarca, chills, rigors Chest pain, malaise