natgillin/translations-raw huggingface dataset:
Cases of overdose (2-3 times the prescribed dose for several weeks) have been reported.
Poročali so o primerih prevelikega odmerjanja (nekaj tednov z odmerki, ki so 2 do 3- krat presegali predpisani odmerek).
Single doses of 80 mg/ kg in iron-overloaded thalassaemic patients caused mild nausea and diarrhoea.
Pri bolnikih s talasemijo in preobremenitvijo z železom so enkratni odmerki 80 mg/ kg povzročili blago navzeo in drisko.
Acute signs of overdose may include nausea, vomiting, headache and diarrhoea.
Akutni znaki prevelikega odmerjanja lahko vključujejo navzeo, bruhanje, glavobol in drisko.
Overdose may be treated by induction of emesis or by gastric lavage, and by symptomatic treatment.
Preveliko odmerjanje je mogoče zdraviti s spodbujanjem bruhanja ali z želodčno lavažo in s simptomatskim zdravljenjem.
Iron chelating agent, ATC code:
Farmakoterapevtska skupina: kelator železa, oznaka ATC:
It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Je trovalenten ligand, ki veže železo z visoko afiniteto v razmerju 2: 1.
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.
V presnovni študiji ravnovesja železa je pri odraslih bolnikih s talasemijo in preobremenitvijo z železom EXJADE v dnevnem odmerku 10, 20 in 40 mg/ kg povzročil povprečno neto ekskrecijo 0, 119, 0, 329 oziroma 0, 445 mg Fe/ kg telesne mase/ dan.
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.
EXJADE so raziskovali pri 411 odraslih (starih 16 let ali več) in 292 pediatričnih bolnikih (starih od 2 do 16 let) s kronično preobremenitvijo z železom zaradi transfuzij krvi.
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).
Osnovne bolezni, zaradi katerih so bile potrebne transfuzije, so vključevale beta talasemijo, srpastocelično anemijo in druge prirojene in pridobljene anemije (mielodisplastični sindrom, Diamond- Blackfan sindrom, aplastično anemijo in druge zelo redke anemije).
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.
Pri odraslih in pediatričnih bolnikih z beta talasemijo in s pogostimi transfuzijami je vsakodnevno zdravljenje z odmerki 20 in 30 mg/ kg v obdobju enega leta povzročilo zmanjšanje kazalcev celotnega železa v organizmu: koncentracija železa v jetrih se je znižala v povprečju za približno - 0, 4 oziroma - 8, 9 mg Fe/ g jeter (suhe teže bioptičnega materiala (suhe teže)), feritin v serumu pa se je v povprečju znižal za približno - 36 oziroma - 926 µg/ l.
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.
Pri enakih odmerkih je bilo razmerje med izločanjem in privzemom železa 1, 02 (kar kaže na neto ravnovesje železa) oziroma 1, 67 (kar kaže na neto odstranjevanje železa).
EXJADE induced similar responses in iron- overloaded patients with other anaemias.
EXJADE je povzročil podobne odzive tudi pri bolnikih z drugimi anemijami in s preobremenitvijo z železom.
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.
Dnevni odmerek 10 mg/ kg v obdobju enega leta je lahko vzdrževal koncentraciji železa v jetrih in feritina v serumu ter vzpostavil neto ravnovesje železa pri bolnikih, ki so poredko prejemali transfuzije ali so prejeli izmenjalne transfuzije.
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.
Feritin v serumu, ki so ga spremljali mesečno, je odražal spremembe v koncentraciji železa v jetrih, kar nakazuje, da se lahko trende feritina v serumu uporabi za spremljanje odziva na zdravljenje.
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).
Omejeni klinični podatki (29 bolnikov z normalnim delovanjem srca ob izhodišču), pridobljeni z magnetnoresonančnim slikanjem (MRI), kažejo, da zdravljenje z zdravilom EXJADE v odmerku 10- 30 mg/ kg/ dan v obdobju 1 leta lahko zniža tudi koncentracije železa v srcu (v povprečju se je MRI T2 * podaljšal z 18, 3 na 23, 0 milisekunde).
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.
Osnovna analiza podatkov ključne primerjalne študije s 586 bolniki z beta talasemijo in s preobremenitvijo z železom zaradi transfuzij ni dokazala neinferiornosti zdravila EXJADE v primerjavi z deferoksaminom v analizi celotne populacije bolnikov.
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.
Post hoc analiza te študije pa je pokazala, da so bili kriteriji za neinferiornost doseženi pri podskupini bolnikov, pri katerih je bila koncentracija železa v jetrih ≥7 mg Fe/ g suhe teže, zdravljeni pa so bili bodisi z zdravilom EXJADE (20 in 30 mg/ kg) ali deferoksaminom (35 do ≥50 mg/ kg).
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.
Pri bolnikih s koncentracijo železa v jetrih < 7 mg Fe/ g suhe teže, zdravljenih bodisi z zdravilom EXJADE (5 in 10 mg/ kg) ali deferoksaminom
Fifty- six patients under the age of 6 years participated in this pivotal study, 28 of them receiving EXJADE.
V to ključno študijo je bilo vključenih 56 bolnikov mlajših od 6 let, od teh jih je 28 prejemalo EXJADE.
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).
Na osnovi predkliničnih in kliničnih študij je postalo razvidno, da je EXJADE lahko prav tako učinkovit kot deferoksamin, če se ga uporablja v razmerju odmerkov 2: 1 (to je odmerek zdravila EXJADE, ki je številčno enak polovici odmerka deferoksamina).
However, this dosing recommendation was not prospectively assessed in the clinical trials.
Vendar pa tega priporočila za odmerjanje niso prospektivno ocenili v kliničnih preskušanjih.
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.
Poleg tega je pri bolnikih s koncentracijo železa v jetrih ≥7 mg Fe/ g suhe teže in z različnimi redkimi vrstami anemije ali s srpastocelično anemijo EXJADE v odmerkih do 20 in 30 mg/ kg povzročil primerljivo znižanje koncentracije železa v jetrih in feritina v serumu v primerjavi z bolniki z beta talasemijo.
Absorption U
UAbsorpcija
The absolute bioavailability (AUC) of deferasirox from
Deferasiroks se po zaužitju absorbira do največje koncentracije v plazmi (tBmax v medianem času B)
B
približno 1, 5 do 4 ure.
EXJADE tablets is about 70% compared to an intravenous dose.
Absolutna biološka uporabnost (AUC) deferasiroksa iz tablet EXJADE je okrog 70% v primerjavi z intravenskim odmerkom.
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.
Ob sočasnem zaužitju z maščobami bogatega zajtrka (vsebnost maščob > 50% kalorij) se je celotna izpostavljenost (AUC) približno podvojila, ob sočasnem zaužitju standardnega zajtrka pa se je povečala za okrog 50%.
13– 25%) elevated when taken 30 minutes before meals with normal or high fat content.
Če je bil deferasiroks zaužit 30 minut pred obroki z normalno ali visoko vsebnostjo maščob, se je njegova biološka razpoložljivost (AUC) zmerno (približno 13- 25%) povečala.
Distribution U U
UPorazdelitevU
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.
Ima majhen volumen porazdelitve, približno 14 litrov pri odraslih.
Biotransformation U U
UBiotransformacijaU
Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur.
Z veliko verjetnostjo se glukuronidi v črevesu dekonjugirajo in nato ponovno absorbirajo (enterohepatična cirkulacija).
CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%).
Kaže, da poteka s CYP450 kataliziran (oksidativni) metabolizem deferasiroksa pri ljudeh le v majhnem obsegu (približno 8%).
No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro.
In vitro niso opazili nobene inhibicije metabolizma deferaksiroksa zaradi hidroksiuree.
Elimination U U
UIzločanjeU
Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose).
Deferasiroks in njegovi presnovki se pretežno izločajo z blatom (84% odmerka).
Renal excretion of deferasirox and its metabolites is minimal (8% of the dose).
Izločanje deferasiroksa in njegovih presnovkov preko ledvic je le minimalno (8% odmerka).
The mean elimination half-life (t 1/ 2)
Povprečen razpolovni čas izločanja (tB1/ 2 je bil med 8 in 16 urami.
The transporters MRP2 and MXR (BCRP) are involved in the biliary excretion of deferasirox.
vključena prenašalca MRP2 in MXR (BCRP).
Linearity / non-linearity U
/ nelinearnost ULinearnost
The C max and AUC 0-24h of deferasirox increase approximately linearly with dose under steady-state
CBmax in AUCB0- 24h deferasiroksa naraščata približno linearno z odmerkom v pogojih dinamičnega
conditions.
ravnovesja.
Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3.
Po večkratnem odmerjanju se je izpostavljenost povečala za akumulacijski faktor 1, 3 do 2, 3.
Characteristics in patients U
pri bolnikih UPosebnosti
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.
Pediatrični bolniki Celotna izpostavljenost deferasiroksu po enkratnem in po večkratnih odmerkih, je bila pri mladostnikih (12 do ≤17 let) in otrocih (2 do < 12 let) nižja kot pri odraslih bolnikih.
In children younger than 6 years old exposure was about 50% lower than in adults.
Pri otrocih mlajših od 6 let, je bila izpostavljenost približno 50% nižja kot pri odraslih.
Gender Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
10 Spol Ženske imajo zmerno nižji navidezni očistek (za 17, 5%) deferasiroksa v primerjavi z moškimi.
10 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
Okvara ledvic ali jeter Farmakokinetika deferasiroksa pri bolnikih z okvaro ledvic ali jeter ni bila proučena.
The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
Vrednosti jetrnih transaminaz do 5- kratnika zgornje meje normalnega okvira niso vplivale na farmakokinetiko deferasiroksa.
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.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti ali kancerogenega potenciala ne kažejo posebnega tveganja za bolnike s preobremenitvijo z železom.
The main findings were kidney toxicity and lens opacity (cataracts).
Ugotovili so predvsem toksičnost za ledvice in motnjavo leče (katarakto).
Tests of genotoxicity in vitro were either negative (Ames test, chromosomal aberration test) or positive (V79 screen).
Testi genotoksičnosti in vitro so bili bodisi negativni (Amesov test, test kromosomskih aberacij) bodisi pozitivni (s celicami V79).
Deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of non-iron-loaded rats at lethal doses.
Deferasiroks je v smrtonosnih odmerkih in vivo povzročil tvorbo mikronukleusov v kostnem mozgu, ne pa v jetrih pri podganah, ki niso bile obremenjene z železom.
Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/ - heterozygous mice in a 6-month study.
Deferasiroks ni bil karcinogen, ko so ga uporabili pri podganah v 2- letni študiji in transgenskih p53+ / - heterozigotnih miših v 6- mesečni študiji.
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.
Deferasiroks ni bil teratogen, je pa povzročil povečano pogostnost skeletnih sprememb in mrtvorojenih mladičev pri podganah v visokih odmerkih, ki so bili zelo toksični za matere, katere niso bile preobremenjene z železom.
Lactose monohydrate Crospovidone type A Cellulose, microcrystalline Povidone Sodium lauryl sulphate Silica, colloidal anhydrous Magnesium stearate
laktoza monohidrat krospovidon tipa A celuloza, mikrokristalna povidon natrijev lavrilsulfat brezvoden koloidni silicijev dioksid magnezijev stearat
6.3 Shelf life
11 6. 3 Rok uporabnosti
PVC/ PE/ PVDC/ Aluminium blisters.
PVC/ PE/ PVDC/ aluminijski pretisni omoti
11 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
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).
Začetni dnevni odmerek 10 mg/ kg je lahko primeren za bolnike, pri katerih ni treba znižati ravni železa v organizmu in prejemajo manj kot 7 ml/ kg/ mesec koncentriranih eritrocitov (približno < 2 enoti/ mesec pri odraslem).
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE that is numerically half that of the deferoxamine dose could be considered (e. g. a patient receiving 40 mg/ kg/ day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/ kg/ day of EXJADE).
13 Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE številčno enak polovici odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/ kg/ dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 20 mg/ kg/ dan zdravila EXJADE).
14 4.4 Special warnings and precautions for use
14 4. 4 Posebna opozorila in previdnostni ukrepi
15 Hepatic function:
15 jeter:
16 The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
16 Izvide meritev kreatinina, feritina in transaminaz v serumu je treba beležiti in redno ocenjevati njihove trende.
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
[2, 03- 2, 63]) in zvišala njegovo CBmax
17 (see section 4.4).
17 koncentracijo glukoze v krvi (glejte poglavje 4. 4).
The concomitant administration of EXJADE with anticoagulants may also increase the risk of gastrointestinal haemorrhage.
Sočasna uporaba zdravila EXJADE z antikoagulanti lahko tudi poveča tveganje za gastrointestinalne krvavitve.
18 Gallstones and related biliary disorders were reported in about 2% of patients.
18 O žolčnih kamnih in z njimi povezanimi boleznimi žolčnika in žolčevodov so poročali pri približno 2% bolnikov.
19 4.9 Overdose
19 4. 9 Preveliko odmerjanje
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).
Na osnovi predkliničnih in kliničnih študij je postalo razvidno, da je EXJADE lahko prav tako učinkovit kot deferoksamin, če se ga uporablja v razmerju odmerkov 2: 1 (to je odmerek zdravila EXJADE, ki je številčno enak polovici odmerka deferoksamina).
Gender Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
21 Spol Ženske imajo zmerno nižji navidezni očistek (za 17, 5%) deferasiroksa v primerjavi z moškimi.
21 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
Okvara ledvic ali jeter Farmakokinetika deferasiroksa pri bolnikih z okvaro ledvic ali jeter ni bila proučena.
6.3 Shelf life
22 6. 3 Rok uporabnosti
22 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
24 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).
Začetni dnevni odmerek 10 mg/ kg je lahko primeren za bolnike, pri katerih ni treba znižati ravni železa v organizmu in prejemajo manj kot 7 ml/ kg/ mesec koncentriranih eritrocitov (približno < 2 enoti/ mesec pri odraslem).
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE that is numerically half that of the deferoxamine dose could be considered (e. g. a patient receiving 40 mg/ kg/ day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/ kg/ day of EXJADE).
24 Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE številčno enak polovici odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/ kg/ dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 20 mg/ kg/ dan zdravila EXJADE).
25 4.4 Special warnings and precautions for use
25 4. 4 Posebna opozorila in previdnostni ukrepi
26 Hepatic function:
26 jeter:
27 The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
27 Izvide meritev kreatinina, feritina in transaminaz v serumu je treba beležiti in redno ocenjevati njihove trende.
28 (see section 4.4).
28 koncentracijo glukoze v krvi (glejte poglavje 4. 4).
29 Gallstones and related biliary disorders were reported in about 2% of patients.
29 O žolčnih kamnih in z njimi povezanimi boleznimi žolčnika in žolčevodov so poročali pri približno 2% bolnikov.
30 4.9 Overdose
30 4. 9 Preveliko odmerjanje
31 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).
Na osnovi predkliničnih in kliničnih študij je postalo razvidno, da je EXJADE lahko prav tako učinkovit kot deferoksamin, če se ga uporablja v razmerju odmerkov 2: 1 (to je odmerek zdravila EXJADE, ki je številčno enak polovici odmerka deferoksamina).
Gender Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
32 Spol Ženske imajo zmerno nižji navidezni očistek (za 17, 5%) deferasiroksa v primerjavi z moškimi.
32 Renal or hepatic impairment The pharmacokinetics of deferasirox have not been studied in patients with renal or hepatic impairment.
Okvara ledvic ali jeter Farmakokinetika deferasiroksa pri bolnikih z okvaro ledvic ali jeter ni bila proučena.
6.3 Shelf life
33 6. 3 Rok uporabnosti
33 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
Name and address of the manufacturer responsible for batch release U U
in naslov izdelovalca, odgovornega za sproščanje serijeU UIme
The MAH shall set up a surveillance programme to collect information on the demographics of patients prescribed Exjade, any adverse reactions and reasons for discontinuation of Exjade.
Imetnik dovoljenja za promet z zdravilom bo pripravil raziskovalni program, s katerim bo zbiral demografske podatke o bolnikih, ki so jim predpisali Exjade, informacije o kakršnihkoli neželenih učinkih in razlogih za prenehanje jemanja zdravila Exjade.
The formal protocols for the sentinel monitoring surveillance should be reviewed by the CHMP.
Določene protokole za pozorno spremljanje in nadzor mora pregledati Odbor za zdravila za uporabo v humani medicini (CHMP).
That Exjade causes rises in serum creatinine in some patients o The need to monitor serum creatinine • On two occasions prior to initiation of treatment • Every week during the first month of initiation of treatment or after therapy modification • Monthly thereafter
dejstvo, da Exjade pri nekaterih bolnikih povzroča zvišanje kreatinina v serumu, o potrebnost spremljanja kreatinina v serumu, • ob dveh priložnostih pred uvedbo zdravljenja, • vsak teden v prvem mesecu po uvedbi ali spremembi zdravljenja, • kasneje pa enkrat mesečno;
The need to reduce by 10 mg/kg the dose if serum creatinine rises: • Adults: > 33% above baseline and creatinine clearance < LLN (90 ml/min) • Paediatrics: either > ULN or creatinine clearance falls to < LLN at two consecutive visits.
90 ml/ min) • pri pediatričnih bolnikih: nad ZMN (zgornjo mejo normale) ali pa očistek kreatinina pade pod SMN pri dveh zaporednih obiskih;
The need t o interrupt treatment after a dose reduction if serum creatinine rises: • Adults and Paediatrics: remain > 33% above baseline or creatinine clearance < LLN (90 ml/min)
potrebnost prekinitve zdravljenja po predhodnem zmanjšanju odmerka, če zvišan o kreatinin v serumu: • pri odraslih in pediatričnih bolnikih: ostane > 33% nad izhodiščno vrednostjo ali pa očistek kreatinina ostane pod SMN (90 ml/ min);
36
36 potrebnost razmisleka o ledvični biopsiji: o • kadar je kreatinin v serumu zvišan in se pokaže še druga nepravilnost (kot je proteinurija, znaki Fanconijevega sindroma);
• The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance • That rises in serum transaminases occur in patients treated with Exjade o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted. • The need for annual auditory and ophthalmic testing
• pomembnost merjenja očistka kreatinina; • kratek pregled metod merjenja očistka kreatinina; • dejstvo, da pri bolnikih, ki se zdravijo z zdravilom Exjade, prihaja do zvišanja vrednosti serumskih transaminaz, o potrebnost izvajanja testov jetrne funkcije preden se predpiše zdravilo, nato pa v mesečnih intervalih ali bolj pogosto, če je klinično indicirano, o opozorilo, da se bolnikom s predhodno hudo boleznijo jeter zdravila ne sme predpisati, o potrebnost prekinitve zdravljenja, če pride do persistentnega in progresivnega zvišanja vrednosti jetrnih encimov; • potrebnost enkrat letnega slušnega in okulističnega pregleda;