natgillin/translations-raw huggingface dataset:
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be lifethreatening or fatal, have been reported.
Prijavljene su teške kožne nuspojave uključujući Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne.
In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor (repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 73% to 95%).
U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroksa kao inhibitora CYP1A2 (ponovljene doze od 30 mg/kg/dan, formulacija tablete za oralnu suspenziju) i supstrata CYP1A2 teofilina (jednokratna doza od 120 mg) rezultirala je povećanjem AUC teofilina za 84% (90% CI: 73% do 95%).
84 dispersible tablets
84 tablete za oralnu suspenziju
EXJADE is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.
EXJADE se također koristi za liječenje kroničnog preopterećenja željezom kada je terapija deferoksaminom kontraindicirana ili neodgovarajuća u bolesnika s beta-talasemijom major s preopterećenjem željezom uzrokovanim rijetkim transfuzijama krvi, u bolesnika s ostalim vrstama anemija te u djece u dobi od 2 do 5 godina.
EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
EXJADE granule trebaju se uzeti posipanjem cijele doze na meku hranu kao što je jogurt ili jabučna kaša (pire od jabuke).
- if you experience frequent abdominal pain, particularly after eating or taking EXJADE.
- ako imate česte bolove u trbuhu, posebno nakon jela ili uzimanja lijeka EXJADE. - ako imate česte žgaravice.
5-10 mg/kg/day Up to 40 mg/kg/day Decrease 3.5 - 7 mg/kg/day 5-10 mg/kg/day
5-10 mg/kg/dan Do 40 mg/kg/dan Smanjenje 3,5 - 7 mg/kg/dan 5-10 mg/kg/dan
Deferasirox has been studied only in patients with baseline serum creatinine within the age-appropriate normal range.
Deferasiroks je ispitivan samo u bolesnika čije su vrijednosti kreatinina u serumu na početku liječenja bile unutar granica normalnog raspona odgovarajućeg za dob.
30 film-coated tablets 90 film-coated tablets
Filmom obložene tablete 30 filmom obloženih tableta 90 filmom obloženih tableta
Cardiac function should be monitored in patients with severe iron overload during long-term treatment with EXJADE.
U bolesnika s teškim preopterećenjem željezom potrebno je, pri dugotrajnom liječenju lijekom EXJADE, pratiti funkciju srca.
Bioavailability of deferasirox granules was 52% greater than that with dispersible tablets.
Bioraspoloživost deferasiroks granula bila je 52% veća od bioraspoloživosti tableta za oralnu suspenziju.
Prior to therapy.
Prije terapije.
>33% above pretreatment average and Decreases <LLN* (<90 ml/min)
> 33% iznad prosjeka prije liječenja i smanjen <DGN-a* (<90 ml/min)
Clinical study in patients with non-transfusion-dependent thalassaemia syndromes In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea (7.3%) were the most frequent study drug-related adverse events.
U jednogodišnjem ispitivanju u bolesnika sa sindromima talasemije neovisnim o transfuziji i s preopterećenjem željezom (tablete za oralnu suspenziju u dozi od 10 mg/kg/dan), najčešći štetni događaji povezani s ispitivanim lijekom bili su proljev (9,1%), osip (9,1%) i mučnina (7,3%).
The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica and poloxamer.
Drugi sastojci su mikrokristalična celuloza, krospovidon, povidon, magnezijev stearat, koloidni bezvodni silicijev dioksid i poloksamer.
• Do not use this medicine after the expiry date which is stated on the sachet and the carton after EXP.
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vrećici i kutiji iza oznake „Rok valjanosti“/„EXP“.
• EXJADE 90 mg film-coated tablets are light blue and stamped “90” on one side and “NVR” on the other.
• EXJADE 90 mg filmom obložene tablete su svijetlo plave i na jednoj strani imaju otisnutu oznaku „90“, a na drugoj strani „NVR“.
Lactose content The dispersible tablets contain lactose.
Svaka tableta za oralnu suspenziju sadrži laktozu.
The availability of long-term efficacy and safety data from clinical studies conducted with EXJADE dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation).
Trenutačno se raspolaže tek ograničenim podacima iz provedenih kliničkih ispitivanja o dugotrajnoj djelotvornosti i sigurnosti EXJADE tableta za oralnu suspenziju pri dozama iznad 30 mg/kg (264 bolesnika koji su bili praćeni prosječno 1 godinu nakon povećavanja doze).
If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible.
Ako se pri dozama iznad 30 mg/kg ne postiže zadovoljavajuća kontrola, liječenje takvim dozama se ne treba nastaviti i potrebno je razmotriti druge mogućnosti liječenja kad god je to moguće.
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 deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to ≥50 mg/kg), the non-inferiority criteria were achieved.
Post hoc analiza ovog ispitivanja je pokazala da su mjerila neinferiornosti, čini se, bila zadovoljena u podskupini bolesnika s koncentracijom željeza u jetri ≥7 mg Fe/g suhe težine liječenih deferasiroks tabletama za oralnu suspenziju (20 i 30 mg/kg) ili deferoksaminom (35 do ≥50 mg/kg).
If you are switching from the film-coated tablets or granules to these dispersible tablets, you will need an adjustment of the dose.
Ako prelazite s filmom obloženih tableta ili granula na ove tablete za oralnu suspenziju, bit će Vam potrebna prilagodba doze.
or >1,000 µg/l
KE-a ili >1000 µg/l
How to take EXJADE
Kako uzimati EXJADE
EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older.
EXJADE se koristi za liječenje kroničnog preopterećenja željezom uzrokovanog čestim transfuzijama krvi u bolesnika s beta-talasemijom major u dobi od 6 godina i starijih.
Deferasirox also comes as “dispersible” tablets.
Deferasiroks je dostupan i u obliku tableta za „oralnu suspenziju“.
• The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
• potreba za tabličnim prikazom vrijednosti serumskog kreatinina, klirensa kreatinina, proteinurije, jetrenih enzima, feritina, izmjerenih prije početka liječenja, npr.: Prije početka liječenja Serumski kreatinin na dan - X
In case of switching from dispersible tablets to granules, the dose of the granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole sachet.
U slučaju prelaska s tableta za oralnu suspenziju na granule, doza granula treba biti 30% manja od doze tableta za oralnu suspenziju, zaokruženo na najbližu cijelu vrećicu.
Approximate tablet dimensions 17 mm x 6.7 mm.
Približne dimenzije tablete 17 mm x 6,7 mm.
• Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min)
• odrasli bolesnici: >33% iznad početne vrijednosti i klirens kreatinina <DGN (90 ml/min)
During clinical studies, 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.
Tijekom kliničkih ispitivanja u otprilike 36% bolesnika dogodila su se povišenja serumskog kreatinina za >33% kod ≥2 uzastopne provjere, katkada i iznad gornje granice normalnog raspona.
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg.
U bolesnika u kojih LIC nije utvrđen i serumski feritin je ≤2000 µg/l, doziranje ne smije prelaziti 7 mg/kg.
PVC/PVDC/Aluminium blisters.
6.5 Vrsta i sadržaj spremnika PVC/PVDC/aluminij blisteri.
• Patient guide
• Vodič za bolesnike
PVC/PE/PVDC/Aluminium blisters.
6.5 Vrsta i sadržaj spremnika PVC/PE/PVDC/ aluminij blisteri.
Test
Pretrage
EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
EXJADE filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka EXJADE u obliku tableta za oralnu suspenziju (vidjeti dio 5.2).
The multipacks contain 300 (10 packs of 30) film-coated tablets.
Višestruko pakiranje sadrži 300 (10 pakiranja od 30) filmom obloženih tableta.
The granules should be administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple).
Granule treba primijeniti posipanjem cijele doze na meku hranu, npr. jogurt ili jabučnu kašu (pire od jabuke).
Titanium dioxide (E171) Macrogol (4000)
Ovojnica: hipromeloza titanijev dioksid (E171) makrogol (4000) talk indigo carmine aluminium lake (E132)
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
EXJADE granule pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka EXJADE u obliku tableta za oralnu suspenziju (vidjeti dio 5.2).
In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg.
U pedijatrijskih bolesnika sa sindromima talasemije neovisnim o transfuziji doza ne smije prelaziti 10 mg/kg.
EXJADE 125 mg dispersible tablets EXJADE 250 mg dispersible tablets EXJADE 500 mg dispersible tablets
EXJADE 125 mg tablete za oralnu suspenziju EXJADE 250 mg tablete za oralnu suspenziju EXJADE 500 mg tablete za oralnu suspenziju
Approximate tablet dimensions 14 mm x 5.5 mm.
Približne dimenzije tablete 14 mm x 5,5 mm.
EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets
EXJADE 90 mg filmom obložene tablete EXJADE 180 mg filmom obložene tablete EXJADE 360 mg filmom obložene tablete
In patients treated with doses greater than 30 mg/kg, dose reductions in steps of 5 to 10 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time).
U bolesnika liječenih dozama većim od 30 mg/kg treba razmotriti snižavanje doze u koracima od 5 do 10 mg/kg u slučaju kada je postignuta kontrola (npr. razine feritina u serumu su stalno ispod 2500 µg/l i pokazuju trend opadanja tijekom vremena).
In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% CI: 8% - 26%).
Interakcija s midazolamom i drugim lijekovima koji se metaboliziraju putem CYP3A4 U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroks tableta za oralnu suspenziju i midazolama (test supstrat za CYP3A4) rezultirala je smanjenjem izloženosti midazolamu za 17% (90% CI: 8% - 26%).
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of EXJADE (see section 4.4).
Uz primjenu lijeka EXJADE prijavljene su teške kožne nuspojave, uključujući Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS) (vidjeti dio 4.4).
In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 5 to 10 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation.
U bolesnika u kojih je razina feritina u serumu dostigla cilj (obično između 500 i 1000 µg/l) treba se razmotriti snižavanje doze u koracima od 5 do 10 mg/kg kako bi se održale razine feritina u serumu unutar ciljnog raspona te kako bi se rizik od prekomjerne kelacije sveo na najmanju moguću mjeru.
In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) and 1.6-fold (90% CI [1.42-1.84]), respectively.
Interakcija s repaglinidom i drugim lijekovima koji se metaboliziraju putem CYP2C8 U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroksa kao umjerenog inhibitora CYP2C8 (30 mg/kg dnevno, formulacija tablete za oralnu suspenziju) s repaglinidom, supstratom CYP2C8, u jednokratnoj dozi od 0,5 mg, povećala je AUC repaglinida za oko 2,3 puta (90% CI [2,03 2,63]) i Cmax repaglinida za 1,6 puta (90% CI [1,42 1,84]).
28 dispersible tablets
28 tableta za oralnu suspenziju
Interruption of EXJADE therapy should be considered in patients who develop metabolic acidosis.
U bolesnika koji razviju metaboličku acidozu mora se razmotriti prekid terapije lijekom EXJADE.
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg.
U bolesnika u kojih LIC nije utvrđen i serumski feritin je ≤2000 µg/l, doziranje ne smije prelaziti10 mg/kg.
For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
U bolesnika u kojih je doza povećana na >10 mg/kg, preporučuje se smanjenje doze na 10 mg/kg ili manje kad je LIC <7 mg Fe/g težine suhog tkiva jetre ili je serumski feritin ≤2000 µg/l.
In patients not adequately controlled with doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 28 mg/kg may be considered.
U bolesnika neodgovarajuće kontroliranih dozama od 21 mg/kg (tj. razine feritina u serumu su stalno iznad 2500 µg/l i ne pokazuju trend opadanja tijekom vremena) može se razmotriti primjena doza do 28 mg/kg.
For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
U bolesnika u kojih je doza povećana na >7 mg/kg, preporučuje se smanjenje doze na 7 mg/kg ili manje kad je LIC <7 mg Fe/g težine suhog tkiva jetre ili je serumski feritin ≤2000 µg/l.
Approximate tablet dimensions 12 mm x 3.6 mm.
Približne dimenzije tablete 12 mm x 3,6 mm.
Approximate tablet dimensions 10.7 mm x 4.2 mm.
Približne dimenzije tablete 10,7 mm x 4,2 mm.
Approximate tablet dimensions 20 mm x 5.6 mm.
Približne dimenzije tablete 20 mm x 5,6 mm.
If only very poor haemosiderosis control is achieved at doses up to 30 mg/kg, a further increase (to a maximum of 40 mg/kg) may not achieve satisfactory control, and alternative treatment options may be considered.
Ako je pri dozama do 30 mg/kg postignuta vrlo slaba kontrola hemosideroze, moguće je da se zadovoljavajuća kontrola neće postići ni daljnjim povećanjem doze (na najviše 40 mg/kg) pa je u tom slučaju potrebno razmotriti druge mogućnosti liječenja.
In patients not adequately controlled with doses of 30 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 40 mg/kg may be considered.
U bolesnika neodgovarajuće kontroliranih dozama od 30 mg/kg (tj. razine feritina u serumu su stalno iznad 2500 µg/l i ne pokazuju trend opadanja tijekom vremena) može se razmotriti primjena doza do 40 mg/kg.
14 mg/kg/day 20 mg/kg/day
14 mg/kg/dan 20 mg/kg/dan
Exjade 90 mg granules deferasirox
Exjade 90 mg granule deferasiroks
EXJADE film-coated tablets may be taken either on an empty stomach or with a light meal, preferably at the same time each day (see sections 4.2 and 5.2).
EXJADE filmom obložene tablete mogu se uzimati ili na prazan želudac ili uz lagani obrok, po mogućnosti svakoga dana u isto vrijeme (vidjeti dijelove 4.2 i 5.2).
EXJADE contains lactose
EXJADE sadrži laktozu
• If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes,
• Ako primijetite kombinaciju bilo kojih od sljedećih simptoma: osip, crvenu kožu, mjehuriće na usnicama, očima ili u ustima, ljuštenje kože, vrućicu, simptome nalik gripi, povećane limfne čvorove (znakovi teških kožnih reakcija),
EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
EXJADE filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka EXJADE u obliku tableta za oralnu suspenziju.
INTERMEDIATE CARTON OF MULTIPACK (without blue box)
SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (bez plavog okvira)
The patient's serum ferritin should be monitored during and after the combination, and the dose of EXJADE adjusted if necessary.
Tijekom i nakon primjene kombinacije potrebno je pratiti serumski feritin u bolesnika te prilagoditi dozu lijeka EXJADE ako je potrebno.
Starting dose The recommended initial daily dose of EXJADE film-coated tablets is 14 mg/kg body weight.
Početna doza Preporučena početna dnevna doza EXJADE filmom obloženih tableta je 14 mg/kg tjelesne težine.
EXJADE 360 mg film-coated tablets
EXJADE 360 mg filmom obložene tablete
EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet
EXJADE 90 mg granule u vrećici EXJADE 180 mg granule u vrećici EXJADE 360 mg granule u vrećici
Starting dose The recommended initial daily dose of EXJADE granules is 14 mg/kg body weight.
Početna doza Preporučena početna dnevna doza EXJADE granula je 14 mg/kg tjelesne težine.
• EXJADE 125 mg tablets are stamped “J 125” on one side and “NVR” on the other.
• EXJADE 125 mg tablete na jednoj strani imaju otisnutu oznaku „J 125“, a na drugoj strani
28 mg/kg/day 40 mg/kg/day
28 mg/kg/dan 40 mg/kg/dan
EXJADE 125 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
EXJADE 125 mg tablete za oralnu suspenziju Pakiranje sadrži 28, 84 ili 252 tablete za oralnu suspenziju.
Breast-feeding is not recommended during treatment with EXJADE.
Tijekom liječenja lijekom EXJADE ne preporučuje se dojenje.
EXJADE dispersible tablets must therefore be taken on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.2 and 5.2).
Stoga se EXJADE tablete za oralnu suspenziju moraju uzimati na prazan želudac, najmanje 30 minuta prije jela, po mogućnosti svakoga dana u isto vrijeme (vidjeti dijelove 4.2 i 5.2).
EXJADE 180 mg film-coated tablets
EXJADE 180 mg filmom obložene tablete
EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet Deferasirox
EXJADE 90 mg granule u vrećici EXJADE 180 mg granule u vrećici EXJADE 360 mg granule u vrećici deferasiroks
EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets Deferasirox
EXJADE 90 mg filmom obložene tablete EXJADE 180 mg filmom obložene tablete EXJADE 360 mg filmom obložene tablete deferasiroks
3.5 - 7 mg/kg/day Up to 28 mg/kg/day
3,5 - 7 mg/kg/dan Do 28 mg/kg/dan
Approximate tablet dimensions 15 mm x 4.7 mm.
Približne dimenzije tablete 15 mm x 4,7 mm.
EXJADE 250 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets.
EXJADE 250 mg tablete za oralnu suspenziju Pakiranje sadrži 28, 84 ili 252 tablete za oralnu suspenziju.
3.5 - 7 mg/kg/day 5-10 mg/kg/day Decrease
3,5 - 7 mg/kg/dan 5-10 mg/kg/dan Smanjenje
After every 3 to 6 months of treatment, a dose increase in increments of 3.5 to 7 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well.
Nakon svakih 3 do 6 mjeseci liječenja potrebno je razmotriti mogućnost povećanja doze za 3,5 do 7 mg/kg ako je u bolesnika LIC ≥7 mg Fe/g težine suhog tkiva jetre, odnosno ako je serumski feritin dosljedno >2000 µg/l bez naznaka silaznog trenda, a bolesnik dobro podnosi lijek.
After every 3 to 6 months of treatment, a dose increase in increments of 5 to 10 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well.
Nakon svakih 3 do 6 mjeseci liječenja potrebno je razmotriti mogućnost povećanja doze za 5 do 10 mg/kg ako je u bolesnika LIC ≥7 mg Fe/g težine suhog tkiva jetre, odnosno ako je serumski feritin dosljedno >2000 µg/l bez naznaka silaznog trenda, a bolesnik dobro podnosi lijek.
EXJADE dispersible tablets must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2).
EXJADE tablete za oralnu suspenziju se moraju uzimati jednom dnevno na prazan želudac, najmanje 30 minuta prije obroka, po mogućnosti u isto vrijeme svakog dana (vidjeti dijelove 4.5 i 5.2).
EXJADE 180 mg film-coated tablets EU/1/06/356/014
EXJADE 180 mg filmom obložene tablete EU/1/06/356/014
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded.
Premda u kliničkim ispitivanjima nije bilo opaženo povećanje bubrežnih štetnih događaja nakon postupnog povećavanja doza EXJADE tableta za oralnu suspenziju iznad 30 mg/kg, ne može se isključiti povećani rizik bubrežnih štetnih događaja uz filmom obložene tablete u dozama iznad 21 mg/kg.
EXJADE 180 mg granules EU/1/06/356/021
EXJADE 180 mg granule EU/1/06/356/021
- if you have diarrhoea or vomiting.
- ako imate zamagljen vid. - ako imate proljev ili povraćate.
EXJADE 90 mg film-coated tablets
EXJADE 90 mg filmom obložene tablete
- if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes
- ako primijetite kombinaciju bilo kojih od sljedećih simptoma: osip, crvenu kožu, stvaranje mjehurića na usnicama, očima ili u ustima, ljuštenje kože, vrućicu, simptome nalik gripi,
Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other).
Srednje plava, ovalna, bikonveksna filmom obložena tableta ukošenih rubova s otisnutim oznakama (NVR na jednoj strani i 180 na drugoj strani).
EXJADE 90 mg film-coated tablets EU/1/06/356/011
EXJADE 90 mg filmom obložene tablete EU/1/06/356/011
• EXJADE 250 mg tablets are stamped “J 250” on one side and “NVR” on the other.
• EXJADE 250 mg tablete na jednoj strani imaju otisnutu oznaku „J 250“, a na drugoj strani
EXJADE 360 mg granules EU/1/06/356/022
EXJADE 360 mg granule EU/1/06/356/022
EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox.
EXJADE 360 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 360 mg deferasiroksa.