natgillin/translations-raw huggingface dataset:
Hvis kombinationen er nødvendig, skal der udføres nøje klinisk overvågning samt monitorering af blodglukose (se pkt.
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed
4. 4).
6 (see section 4.4).
4. 4).
An interaction between deferasirox and other CYP2C8 substrates like paclitaxel cannot be excluded (see section 4.4).
Samtidig administration af EXJADE og C- vitamin er ikke formelt undersøgt.
The concomitant administration of EXJADE and vitamin C has not been formally studied.
Doser af C- vitamin på op til 200 mg pr. dag har ikke været sat i forbindelse med utilsigtede følger.
Doses of vitamin C up to 200 mg per day have not been associated with adverse consequences.
4. 4).
The concomitant administration of EXJADE with substances that have known ulcerogenic potential, such as NSAIDs (including acetylsalicylic acid at high dosage), corticosteroids or oral bisphosphonates may increase the risk of gastrointestinal toxicity (see section 4.4).
Samtidig administration af EXJADE med antikoagulantia kan muligvis også øge risikoen for gastrointestinal blødning.
The concomitant administration of EXJADE with anticoagulants may also increase the risk of gastrointestinal haemorrhage.
Graviditet Der foreligger ikke kliniske data om eksponering for deferasirox under graviditet.
No clinical data on exposed pregnancies are available for deferasirox.
5. 3).
Studies in animals have shown some reproductive toxicity at maternally toxic doses (see section 5.3).
Som en forholdsregel, frarådes det at anvende EXJADE under graviditet, medmindre det er strengt nødvendigt.
As a precaution, it is recommended that EXJADE not be used during pregnancy unless clearly necessary.
Amning I dyrestudier blev det konstanteret, at deferasirox hurtigt og i udstrakt grad blev udskilt i modermælken.
In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk.
Amning frarådes under behandling med EXJADE.
Breast- feeding while taking EXJADE is not recommended.
Fertilitet Der er ingen fertilitetsdata tilgængelige for mennesker.
No fertility data is available for humans.
5. 3).
In animals, no adverse effects on male or female fertility were found (see section 5.3).
Der er ikke foretaget undersøgelser af EXJADEs virkning på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects of EXJADE on the ability to drive and use machines have been performed.
4. 8).
Patients experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or operating machinery (see section 4.8).
De hyppigste reaktioner, der er rapporteret under kronisk behandling med EXJADE hos voksne og pædiatriske patienter, inkluderer gastrointestinale forstyrrelser hos omkring 26% af patienterne (hovedsageligt kvalme, opkastning, diarré eller abdominale smerter) og hududslæt hos omkring 7% af patienterne.
The most frequent reactions reported during chronic treatment with EXJADE in adult and paediatric patients include gastrointestinal disturbances in about 26% of patients (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash in about 7% of patients.
Diarré er oftere set hos pædiatriske patienter i alderen 2 til 5 år end hos ældre patienter.
Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients.
Reaktionerne er generelt forbigående, og de holder for det meste op, selvom behandlingen fortsættes.
These reactions are dose- dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.
Forhøjelserne var på > 33% i ≥ 2 på hinanden følgende tilfælde, og nogle gange var de over den øvre grænse af normalområdet.
During clinical trials, increases in serum creatinine of > 33% on ≥ 2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients.
Disse forhøjelser var dosisafhængige.
These were dose- dependent.
Omkring to tredjedele af patienterne med øget serum- kreatinin vendte tilbage til niveauet under 33% uden dosisjustering.
About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment.
I den resterende tredjedel reagerede øgningen af serum- kreatinin ikke altid på en dosisreduktion eller en dosisafbrydelse.
In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
4. 4).
Indeed, in some cases, only a stabilisation of the serum creatinine values has been observed after dose reduction (see section 4.4).
Galdesten og relaterede biliære sygdomme blev rapporteret hos omkring 2% af patienterne.
7 Gallstones and related biliary disorders were reported in about 2% of patients.
Forhøjelser af levertransaminase blev rapporteret som bivirkning hos 2%.
Elevations of liver transaminases were reported as an adverse drug reaction in 2% of patients.
Transaminaseniveauer, der var mere end 10 gange over normalområdets øverste grænse, hvilket indikerer hepatitis, var usædvanlige (0, 3%).
Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%).
4. 4).
During postmarketing experience, hepatic failure, sometimes fatal, has been reported with EXJADE, especially in patients with pre-existing liver cirrhosis (see section 4.4).
4. 4).
As with other iron chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been uncommonly observed in patients treated with EXJADE (see section 4.4).
Meget almindelige (≥ 1/ 10), almindelige (≥ 1/ 100, < 1/ 10), ikke almindelige (≥ 1/ 1. 000, < 1/ 100), sjældne (≥ 1/ 10. 000, < 1/ 1. 000), meget sjældne (< 1/ 10. 000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
Adverse reactions are ranked below using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated form the available data).
Tabel 1
U Table 1
Pancytopeni1, trombocytopeni1
Pancytopenia 1, thrombocytopenia 1 P P P
Nervesystemet
P
Øjne
Nervous system disorders
Tidlig katarakt, makulopati
Early cataract, maculopathy
Smerter i svælg og strube
Pharyngolaryngeal pain
Forhøjet blod- kreatinin
Rare: and urinary disorders Very common:
Proteinuri Renal tubulopati (erhvervet Fanconis syndrom), glycosuri Akut nyresvigt1
Oesophagitis Blood creatinine increased Proteinuria Renal tubulopathy (acquired Fanconi’ s syndrome), glycosuria Acute renal failure 1 P P
Ikke kendte:
Not known:
Udslæt, kløe Pigmentforstyrrelser Leukocytoklastisk vaskulitis1, urticaria1
Rash, pruritus Pigmentation disorder Leukocytoclastic vasculitis 1, urticaria 1 P P P
Lever
Not known:
Ikke kendte: og galdeveje Almindelige:
Common:
Allergiske reaktioner (inklusive anafylaksis og angioødem) 1 Forhøjede transaminase- værdier Hepatitis, galdestenssygdomme Leversvigt1
Transaminases increased Hepatitis, cholelithiasis Hepatic failure 1 P P
Psykiske forstyrrelser 1
Psychiatric disorders
Bivirkninger indberettet fra erfaringer efter markedsføring.
P P Adverse reactions reported during postmarketing experience.
Der er indberettet tilfælde af overdosering (2- 3 gange den foreskrevne dosis i flere uger).
Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported.
Enkelte doser på 80 mg/ kg i jernophobede, thalassæmiske patienter forårsagede mild kvalme og diarré.
Single doses of 80 mg/ kg in iron-overloaded thalassaemic patients caused mild nausea and diarrhoea.
8 Akutte tegn på overdosering kan inkludere kvalme, opkastning, hovedpine og diarré.
Acute signs of overdose may include nausea, vomiting, headache and diarrhoea.
Jernkelerende præparat, ATC- kode:
Iron chelating agent, ATC code:
Det er en tridentat ligand, der binder jern med høj affinitet med en ratio på 2: 1.
It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Deferasirox har lav affinitet for zink og kobber, og forårsager ikke lave serum- niveauer for disse metaller.
Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels of these metals.
I et studie i metabolisk jernbalance hos voksne thalassæmipatienter med jernophobning, forårsagede daglige EXJADE- doser på 10, 20 og 40 mg/ kg en gennemsnitlig nettoudskillelse på henholdsvis 0, 119, 0, 329 og 0, 445 mg Fe/ kg kropsvægt/ dag.
In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, EXJADE at daily doses of 10, 20 and 40 mg/ kg induced the mean net excretion of 0.119, 0.329 and 0.445 mg Fe/ kg body weight/ day, respectively.
EXJADE er undersøgt hos 411 voksne (alder ≥ 16 år) og 292 pædiatriske patienter (alder 2 til < 16 år) med kronisk jernophobning forårsaget af blodtransfusioner.
EXJADE has been investigated in 411 adult (age ≥ 16 years) and 292 paediatric patients (aged 2 to < 16 years) with chronic iron overload due to blood transfusions.
De underliggende tilstande, der krævede blodtransfusion, inkluderede beta - thalassæmi, seglcelleanæmi og andre medfødte og erhvervede anæmier (myelodysplastiske syndromer, Diamond- Blackfan- syndrom, aplastisk anæmi og andre meget sjældne anæmier).
The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes, Diamond- Blackfan syndrome, aplastic anaemia and other very rare anaemias).
Daglig behandling med doser på 20 og 30 mg/ kg i et år hos voksne og pædiatriske patienter med beta- thalassæmi, som hyppigt modtog transfusioner, førte til reduktioner i indikatorer for totalt kropsjern; lever- jernkoncentrationen blev reduceret med henholdsvis omkring - 0, 4 og - 8 mg Fe/ g lever (biopsi- tørvægt) i gennemsnit, og serum- ferritin blev reduceret med henholdsvis omkring - 36 og - 926 µg/ l i gennemsnit.
Daily treatment at doses of 20 and 30 mg/ kg for one year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in indicators of total body iron; liver iron concentration was reduced by about -0.4 and -8.9 mg Fe/ g liver (biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about -36 and -926 µg/ l on average, respectively.
Ved samme doser var ratioen for jernudskillelse: jernindtag henholdsvis 1, 02 (hvilket indikerer netto- jernbalance) og 1, 67 (hvilket indikerer netto- jernudskillelse).
At these same doses the ratios of iron excretion: iron intake were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively.
EXJADE forårsagede lignende respons hos patienter med jernophobning med andre anæmier.
EXJADE induced similar responses in iron- overloaded patients with other anaemias.
Daglige doser på 10 mg/ kg i et år kunne opretholde leverjern og serum- ferritinniveauer og forårsage netto jernbalance hos patienter, der sjældent modtog transfusioner eller udskiftningstransfusioner.
Daily doses of 10 mg/ kg for one year could maintain liver iron and serum ferritin levels and induce net iron balance in patients receiving infrequent transfusions or exchange transfusions.
Dette tyder på, at tendenser i serum- ferritin kan anvendes til at monitorere respons på behandling.
Serum ferritin assessed by monthly monitoring reflected changes in liver iron concentration indicating that trends in serum ferritin can be used to monitor response to therapy.
Begrænsede kliniske data (29 patienter med normal hjertefunktion ved baseline), der blev opnået med MRI, indikerer, at behandling med EXJADE 10- 30 mg/ kg/ dag i 1 år også kan reducere jern- niveauer i hjertet (i gennemsnit, MRI T2 * øget fra 18, 3 til 23, 0 millisekunder).
Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that treatment with EXJADE 10-30 mg/ kg/ day for 1 year may also reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds).
Hovedanalysen af det afgørende sammenligningsstudie hos 586 patienter med beta- thalassæmi og transfusional jernophobning viste ikke non- inferiority af EXJADE sammenlignet med deferoxamin i analysen af den totale patientpopulation.
The principal analysis of the pivotal comparative study in 586 patients suffering from beta- thalassaemia and transfusional iron overload did not demonstrate non-inferiority of EXJADE to deferoxamine in the analysis of the total patient population.
I en post- hoc- analyse af dette studie blev non- inferiority - kriteriet opnået i undergruppen af patienter med lever- jernkoncentration ≥ 7 mg Fe/ g biopsi- tørvægt behandlet med EXJADE (20 og 30 mg/ kg) eller deferoxamin (35 til ≥ 50 mg/ kg).
It appeared from a post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥ 7 mg Fe/ g dw treated with EXJADE (20 and 30 mg/ kg) or deferoxamine (35 to ≥ 50 mg/ kg), the non-inferiority criteria were achieved.
Dette skyldtes ubalance i doseringen af de to kelatorer.
However, in patients with liver iron concentration < 7 mg Fe/ g dw treated with EXJADE (5 and 10 mg/ kg) or deferoxamine (20 to 35 mg/ kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Denne ubalance opstod, fordi patienter på deferoxamin fik tilladelse til at blive på deres før- studiedosering, selvom denne dosis var højere end den protokolspecificerede dosis.
This imbalance occurred because patients on deferoxamine were allowed to remain on their pre-study dose even if it was higher than the protocol specified dose.
56 patienter under 6 år deltog i dette afgørende studie, 28 af dem modtagende EXJADE.
Fifty- six patients under the age of 6 years participated in this pivotal study, 28 of them receiving EXJADE.
Det fremgik af prækliniske og kliniske studier, at EXJADE kunne være ligeså aktivt som deferoxamin, når det blev administreret i en dosisratio på 2: 1 (det vil sige en dosis EXJADE, der numerisk er halvdelen af deferoxamindosis).
9 It appeared from preclinical and clinical studies that EXJADE could be as active as deferoxamine when used in a dose ratio of 2:1 (i. e. a dose of EXJADE that is numerically half of the deferoxamine dose).
Imidlertid blev denne dosisrekommendation ikke vurderet prospektivt i de kliniske studier.
However, this dosing recommendation was not prospectively assessed in the clinical trials.
Dette forekom hos patienter med lever- jernkoncentration ≥ 7 mg Fe/ g biopsi- tørvægt med forskellige sjældne anæmier eller seglcellesygdom.
In addition, in patients with liver iron concentration ≥ 7 mg Fe/ g dw with various rare anaemias or sickle cell disease, EXJADE up to 20 and 30 mg/ kg produced a decrease in liver iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia.
Absorption Deferasirox bliver absorberet efter oral administration med en mediantid til maximum plasmakoncentration (tmax) på omkring 1, 5 til 4 timer.
The absolute bioavailability (AUC) of deferasirox from
Deferasiox ’ absolutte biotilgængelighed (AUC) fra EXJADE tabletter er omkring 70% sammenlignet med en intravenøs dosis.
EXJADE tablets is about 70% compared to an intravenous dose.
Total eksponering (AUC) var cirka fordoblet, når det blev taget samtidigt med høj- fedtholdig morgenmad (fedtindhold > 50% af kalorierne) og med omkring 50%, når det blev taget samtidigt med en almindelig morgenmad.
Total exposure (AUC) was approximately doubled when taken along with a high-fat breakfast (fat content > 50% of calories) and by about 50% when taken along with a standard breakfast.
13- 25%) forhøjet, når det blev taget 30 minutter før måltider med normalt eller højt fedtindhold.
13– 25%) elevated when taken 30 minutes before meals with normal or high fat content.
Distribution Deferasirox er stærkt (99%) proteinbundet til plasmaproteiner.
Distribution U U
Deferasirox er næsten udelukkende bundet til serum- albumin, og har et lavt fordelingsvolumen på omkring 14 liter i voksne.
Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and has a small volume of distribution of approximately 14 litres in adults.
Biotransformation Glucoronidering er den primære metaboliske vej for deferasirox, med efterfølgende udskillelse i galden.
Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion.
Dekonjugering af glucoronidater i tarmen og efterfølgende reabsorbtion (enterohepatisk recirkulation) er sandsynlig.
Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur.
CYP450- katalyseret (oxidativ) metabolisme af deferasirox er tilsyneladende mindre i mennesker (8%).
CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%).
In vitro blev der ikke observeret hæmning af deferasirox- metabolisme af hydroxyurea.
No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro.
Elimination Deferasirox og dets metabolitter bliver primært udskilt i fæces (84% af dosis).
Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose).
Den gennemsnitlige eliminationshalveringstid (t1/ 2) varierede fra 8 til 16 timer.
ranged from 8 to 16 hours.
Linearitet / non- linearitet Cmax og AUC0- 24t for deferasirox øgedes næsten lineært med dosis ved ligevægtstilstande.
The C max and AUC 0-24h of deferasirox increase approximately linearly with dose under steady-state
Ved gentagen dosering øgedes eksponeringen med en akkumulationsfaktor på 1, 3 til 2, 3.
Characteristics in patients U
Karakteristika i patienter Pædiatriske patienter Den samlede eksponering af unge (12 til ≤ 17 år) og børn (2 til ≤ 12 år) for deferasirox efter enkelte og gentagne doser var lavere end for voksne patienter.
Paediatric patients The overall exposure of adolescents (12 to ≤ 17 years) and children (2 to < 12 years) to deferasirox after single and multiple doses was lower than that in adult patients.
Køn Kvinder har en moderat mindre påviselig clearance (med 17, 5%) for deferasirox sammenlignet med mænd.
Gender Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
10 Nedsat nyre - eller leverfunktion Farmakokinetiken for deferasirox er ikke undersøgt hos patienter med nedsat nyre - eller leverfunktion.
10 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
Farmakokinetiken for deferasirox blev ikke påvirket af lever- transaminaseværdier på op til 5 gange den øvre grænse af normalområdet.
The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
De prækliniske data viser ingen særlig risiko for patienter med jernophobning vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
Preclinical data reveal no special hazard for patients with iron overload, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Nyretoksiciteten menes primært at skyldes jernmangel i dyr, der ikke tidligere havde ophobning af jern.
The kidney toxicity is considered mainly due to iron deprivation in animals that were not previously overloaded with iron.
Tests for genotoksicitet in vitro var enten negative (Ames test, chromosomal aberrationtest) eller positive (V79 screening).
Tests of genotoxicity in vitro were either negative (Ames test, chromosomal aberration test) or positive (V79 screen).
Ved dødelige doser i ikke- jernophobede rotter forårsagede deferasirox dannelse af mikronuclei in vivo i knoglemarven, men ikke i leveren.
Deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of non-iron-loaded rats at lethal doses.
Sådanne effekter blev ikke set hos jern- præeksponerede rotter.
No such effects were observed in iron-preloaded rats.
Deferasirox var ikke carcinogent, når det blev administreret til rotter i et 2- års studie og transgene p53+ / - heterozygote mus i et 6- måneders studie.
Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/ - heterozygous mice in a 6-month study.
Derimod forårsagede deferasirox øget frekvens af skeletale forandringer og dødfødte unger hos rotter ved høje doser, der var stærkt toksiske for den ikke- jernophobede moder.
Deferasirox was not teratogenic, but caused increased frequency of skeletal variations and stillborn pups in rats at high doses that were severely toxic to the non-iron-overloaded mother.
Lactosemonohydrat Crospovidon type A Cellulose, mikrokrystallinsk Povidon Natriumlaurilsulfat Silica, kolloid vandfri Magnesiumstearat
Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone Sodium lauryl sulphate Silica, colloidal anhydrous Magnesium stearate
PVC/ PE/ PCDC/ Aluminium blisterpakninger.
PVC/ PE/ PVDC/ Aluminium blisters.
11 6. 6 Regler for destruktion
11 Not all pack sizes may be marketed.
Råhvide, runde, flade tabletter med skrå kanter og prægning (NVR på den ene side og J 250 på den anden).
Off-white, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
13 En startdosis på 10 mg/ kg kan tages i betragtning for patienter, der ikke har brug for reduktion af jern - niveauer i kroppen, og som også modtager mindre end 7 mg/ kg/ måned pakkede røde blodceller (omkring < 2 enheder/ måned for en voksen).
13 An initial daily dose of 10 mg/ kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/ kg/ month of packed red blood cells (approximately < 2 units/ month for an adult).
14 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
14 4.4 Special warnings and precautions for use
15 Leverfunktion:
U U
Resultaterne af tests for serum- kreatinin, serum- ferritin og serum- transaminaser bør registreres og vurderes regelmæssigt for tendenser.
16 The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
16 I de 1- årige kliniske studier blev vækst og kønsudvikling hos pædiatriske patienter, der blev behandlet med EXJADE ikke påvirket.
In the 1-year clinical studies growth and sexual development of paediatric patients treated with EXJADE were not affected.
I et studie med raske frivillige blev det påvist, at administration af deferasirox, som moderat CYP2C8 - hæmmer (30 mg/ kg daglig) samtidig med repaglinid, et CYP2C8- substrat, givet som enkeltdosis på 0, 5 mg, øgede AUC og Cmax for repaglinid med henholdsvis ca.
In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 inhibitor (30 mg/ kg/ daily), with repaglinide, a CYP2C8 substrate, given as a single dose of 0.5 mg, increased repaglinide AUC and C max about 2.3-fold (90% CI [2.03-2.63]) and 1.6-fold (90% CI
4. 4).
17 (see section 4.4).
Galdesten og relaterede biliære sygdomme blev rapporteret hos omkring 2% af patienterne.
18 Gallstones and related biliary disorders were reported in about 2% of patients.
19 Akutte tegn på overdosering kan inkludere kvalme, opkastning, hovedpine og diarré.
Acute signs of overdose may include nausea, vomiting, headache and diarrhoea.
Det fremgik af prækliniske og kliniske studier, at EXJADE kunne være ligeså aktivt som deferoxamin, når det blev administreret i en dosisratio på 2: 1 (det vil sige en dosis EXJADE, der numerisk er halvdelen af deferoxamindosis).
20 It appeared from preclinical and clinical studies that EXJADE could be as active as deferoxamine when used in a dose ratio of 2:1 (i. e. a dose of EXJADE that is numerically half of the deferoxamine dose).
21 Nedsat nyre - eller leverfunktion Farmakokinetiken for deferasirox er ikke undersøgt hos patienter med nedsat nyre - eller leverfunktion.
21 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
22 6. 6 Regler for destruktion
22 Not all pack sizes may be marketed.