FrancophonIA/ELRC3.0 huggingface dataset:
English: Both active substances in Kivexa, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Slovenian: Obe zdravilni učinkovini v zdravilu Kivexa, abakavir in lamivudin, sta nukleozidna zaviralca reverzne transkriptaze (NRTI).
English: What is the risk associated with Kivexa?
Slovenian: Kakšna tveganja so povezana z zdravilom Kivexa?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kivexa, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For more information and the full list of restrictions, see the package leaflet.
Slovenian: Za celoten seznam omejitev glejte navodilo za uporabo.
English: At the time of Kivexa's authorisation, abacavir was authorised at a dose of 300 mg twice a day.
Slovenian: Ko je bilo izdano dovoljenje za zdravilo, je bil odobreni odmerek za abakavir 300 mg dvakrat na dan.
English: The combination tablet taken once a day was also as effective as the medicines taken separately twice a day in reducing viral loads over 24 weeks of treatment.
Slovenian: V 24 tednih zdravljenja je bila kombinirana tableta, ki se jemlje enkrat dnevno, enako učinkovita pri zmanjševanju virusnega bremena kot zdravili, ki se jemljeta ločeno dvakrat na dan.
English: Why has Kivexa been approved?
Slovenian: Zakaj je bilo zdravilo Kivexa odobreno?
English: For the full list of all side effects reported with Kivexa, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kivexa, glejte navodilo za uporabo.
English: Kivexa is taken as one tablet once a day.
Slovenian: Bolnik mora vzeti eno tableto zdravila Kivexa na dan.
English: Patients who need to adjust the dose of abacavir or lamivudine should take the medicines separately.
Slovenian: Daje se lahko samo bolnikom s telesno maso vsaj 25 kg. Bolniki, pri katerih je treba odmerka abakavirja ali lamivudina prilagoditi, morajo zdravili jemati ločeno.
English: How does Kivexa work?
Slovenian: Kako zdravilo Kivexa deluje?
English: What is Kivexa used for?
Slovenian: Za kaj se zdravilo Kivexa uporablja?
English: Treatment with Kivexa should be stopped promptly if the patient has a hypersensitivity reaction.
Slovenian: Če se pri bolniku pojavijo preobčutljivostne reakcije, je treba zdravljenje z zdravilom Kivexa takoj prekiniti.
English: How has Kivexa been studied?
Slovenian: Kako je bilo zdravilo Kivexa raziskano?
English: What is Kivexa?
Slovenian: Kaj je zdravilo Kivexa?
English: How is Kivexa used?
Slovenian: Kako se zdravilo Kivexa uporablja?
English: Initiation pack: 2 cartridges
Slovenian: Začetno pakiranje: 2 vložki
English: Initiation pack: 6 pre-filled syringes of 8.8 µg + 6 pre-filled syringes of 22 µg
Slovenian: Začetno pakiranje: 6 napolnjenih injekcijskih brizg po 8,8 mikrogramov in 6 napolnjenih injekcijskih brizg po 22 mikrogramov
English: 2 October 2013
Slovenian: 2. oktober 2013
English: France is the reference Member State and Austria, Germany, Hungary, the Netherlands, Poland, Romania, Spain and the United Kingdom are concerned Member States.
Slovenian: Referenčna država članica je Francija, zadevne države članice pa so Avstrija, Nemčija, Madžarska, Nizozemska, Poljska, Romunija, Španija in Združeno kraljestvo.
English: International non-proprietary name (INN): altrenogest
Slovenian: Mednarodno nelastniško ime (INN): altrenogest
English: The Committee appointed Dr C. Ibrahim as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur.
Slovenian: Odbor je imenoval dr. C. Ibrahima za poročevalca in dr. M. Holzhauser-Albertija za soporočevalca.
English: The opinion was converted into a Decision by the European Commission on 2 October 2013.
Slovenian: Mnenje je bilo 2. oktobra 2013 spremenjeno v sklep Evropske komisije.
English: The decentralised procedure started on 7 October 2011.
Slovenian: Decentralizirani postopek se je začel 7. oktobra 2011.
English: Written explanations were provided by the applicant on 21 May 2013.
Slovenian: Predlagatelj je 21. maja 2013 podal pisna pojasnila.
English: Potential serious risks were identified during the decentralised procedure by Germany regarding the environmental safety of the product.
Slovenian: Takrat je Nemčija ugotovila možnost resnega tveganja v zvezi z varnostjo zdravila za okolje.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 17 December 2012.
Slovenian: Ker ta vprašanja na 210. dan še vedno niso bila rešena, je bila zadeva 17. decembra 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
English: On 1 March 2013, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Slovenian: Referenčna država članica, Francija, je 1. marca 2013 obvestila Evropsko agencijo za zdravila, da Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)) ni dosegla soglasja v zvezi z zdravilom in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
English: This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Slovenian: Skladno s členom 13(1) Direktive 2001/82/ES, kakor je bila spremenjena, je to generična vloga, ki se nanaša na referenčno zdravilo Regumate oljna raztopina 4 mg/ml.
English: Therefore, the Committee adopted by consensus a positive opinion on 18 July 2013 recommending the granting of a marketing authorisation for Suifertil 4 mg/ml Oral Solution for Pigs and associated names.
Slovenian: Odbor je zato 18. julija 2013 soglasno sprejel pozitivno mnenje, v katerem je priporočil odobritev dovoljenja za promet z zdravilom Suifertil 4 mg/ml peroralna raztopina za prašiče in povezanimi imeni.
English: Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Slovenian: Ker na 60. dan postopka, 14. februarja 2013, zadevne države članice še vedno niso dosegle soglasja v zvezi z zdravilom, je bil postopek napoten na CVMP.
English: Suifertil 4 mg/ml Oral Solution for Pigs contains altrenogest as active ingredient and is intended for use in pigs for the synchronisation of oestrous in sexually mature gilts.
Slovenian: Zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče vsebuje kot zdravilno učinkovino altrenogest in je indicirano za uporabo pri prašičih za sinhronizacijo estrusa pri spolno zrelih mladicah.
English: Having considered all the overall submitted data in writing the CVMP concluded that there is no product specific concern identified for the Suifertil 4 mg/ml Oral Solution for Pigs that is different from the other, already authorised, altrenogest containing veterinary medicinal products.
Slovenian: Odbor CVMP je pisno obravnaval vse predložene podatke in sklenil, da ni pomisleka, specifičnega za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče, ki bi se razlikoval od drugih, podanih za že odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest.
English: The applicant, aniMedica GmbH, submitted an application for a decentralised procedure for Suifertil 4 mg/ml Oral Solution for Pigs and associated names.
Slovenian: Predlagatelj aniMedica GmbH je predložil vlogo za decentralizirani postopek za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče in povezana imena.
English: Opinion following an Article 33(4)0F referral for Suifertil 4 mg/ml Oral Solution for Pigs and associated names
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 33(4)0F za zdravilo Suifertil 4 mg/ml peroralna raztopina za prašiče in povezana imena
English: Ampoule (LDPE) 2.4 ml (100 mg/ml) 56 Ampoules + 1 Nebuliser Handset
Slovenian: 240 mg inhalacijska raztopina za nebulator za inhaliranje ampula (LDPE) 2,4 ml (100 mg/ml) 56 ampul + 1 nebulator
English: Film-coated tablet Oral use
Slovenian: filmsko obložena tablete
English: 15 mg + 20 mg
Slovenian: 7 x 20 mg)
English: Initiation pack: 49 tablets (42 x 15 mg + 7 x 20 mg)
Slovenian: 15 mg + 20 mg filmsko obložena tableta peroralna uporaba pretisni omot (PP/alu) začetno pakiranje: 49 tablet (42 x 15 mg +
English: Packaging Content Package size Withdrawal Period
Slovenian: Ovojnina Vsebina Velikost pakiranja
English: June 2021
Slovenian: junij 2021
English: • Then wait at least 30 minutes before eating any food.
Slovenian: • Nato počakajte vsaj 30 minut, preden zaužijete hrano.
English: Frequency not known (cannot be estimated from the available data).
Slovenian: Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
English: Date of first authorisation: 28 August 2006 Date of latest renewal: 18 April 2016
Slovenian: Datum prve odobritve: 28. avgust 2006 Datum zadnjega podaljšanja: 18. april 2016
English: and Once (1x)
Slovenian: in enkrat (1x)
English: This is a long-term treatment, possibly lasting for months or years.
Slovenian: Gre za dolgotrajno zdravljenje, ki lahko traja mesece ali leta.
English: • Drink everything in the glass.
Slovenian: • Popijte vso vsebino kozarca.
English: The educational programme is aimed to inform healthcare professionals and patients to minimise the risks of:
Slovenian: Izobraževalni program je namenjen predstavitvi informacij zdravstvenim strokovnjakom in bolnikom z namenom zmanjševanja tveganja za:
English: The safety and efficacy of EXJADE in children from birth to 23 months of age have not been established.
Slovenian: Varnost in učinkovitost zdravila EXJADE pri otrocih od rojstva do starosti 23 mesecev nista bili dokazani.
English: The mean elimination half-life (t1/2) ranged from 8 to 16 hours.
Slovenian: Povprečen razpolovni čas izločanja (t1/2) je bil med 8 in 16 urami.
English: Value 2 X and Y are the days (to be determined) when pre-treatment measurements should be performed.
Slovenian: vrednost 2 X in Y sta dneva (ki ju je treba določiti) za izvedbo meritev pred zdravljenjem.
English: If you miss a dose, take it as soon as you remember on that day.
Slovenian: Če ste pozabili vzeti odmerek, ga vzemite isti dan, takoj ko se spomnite.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your EXJADE treatment”).
Slovenian: Vaš zdravnik bo redno spremljal vaše stanje in preverjal, ali zdravljenje učinkuje v skladu s pričakovanji (glejte tudi poglavje 2: “Spremljanje vašega zdravljenja z zdravilom EXJADE”).
English: 1, toxic epidermal necrolysis (TEN)
Slovenian: 1, toksična epidermalna nekroliza (TEN)
English: Do not dissolve the tablets in fizzy drinks or milk.
Slovenian: Tablet ne raztapljajte v šumečih pijačah ali mleku.
English: • Pharmacists - a detailed letter explaining the switch between formulations
Slovenian: • farmacevti - dopis s podrobnim opisom prehajanja med formulacijami,
English: If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take EXJADE”).
Slovenian: Če zdravilo prenehate jemati, se presežek železa ne bo več izločal iz vašega telesa (glejte tudi poglavje zgoraj “Kako dolgo jemati zdravilo EXJADE”).
English: Urgent medical treatment may be necessary.
Slovenian: Morda boste potrebovali nujno medicinsko pomoč.
English: The tablets must not be chewed or swallowed whole (see also section 6.2).
Slovenian: Tablet se ne sme žvečiti ali pogoltniti celih (glejte tudi poglavje 6.2).
English: Take this medicine on an empty stomach.
Slovenian: Zdravilo vzemite na prazen želodec.
English: Do not take EXJADE - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila EXJADE - če ste alergični na deferasiroks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If you have questions about how long to take EXJADE, talk to your doctor.
Slovenian: Če imate vprašanja o tem, kako dolgo jemati zdravilo EXJADE, se pogovorite s svojim zdravnikom.
English: The liquid in the glass will look cloudy.
Slovenian: Tekočina v kozarcu bo videti nekoliko motna.
English: Before initiating treatment Serum creatinine at Day - X
Slovenian: pred uvedbo zdravljenja kreatinin v serumu na dan - X
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed.
Slovenian: Po zaužitju suspenzije je treba preostanek ponovno raztopiti v malo vode ali soka in zaužiti.
English: Your doctor will take these tests into consideration when deciding on the dose of EXJADE most suitable for you and will also use these tests to decide when you should stop taking EXJADE.
Slovenian: Te preiskave bo vaš zdravnik upošteval pri izbiranju za vas najbolj ustreznega odmerka zdravila EXJADE in se na podlagi izvidov teh preiskav tudi odločil, kdaj bi morali prenehati z jemanjem zdravila EXJADE.
English: Table 3 Dose adjustment and interruption of treatment for renal monitoring
Slovenian: Preglednica 3 Prilagajanje odmerkov in prekinitev zdravljenja pri spremljanju delovanja ledvic
English: “NVR” on the other.
Slovenian: “NVR“.
English: Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/- heterozygous mice in a 6-month study.
Slovenian: Deferasiroks ni bil karcinogen, ko so ga uporabili pri podganah v 2-letni študiji in transgenskih p53+/- heterozigotnih miših v 6-mesečni študiji.
English: Do not chew, break or crush the tablets.
Slovenian: Ne žvečite, ne lomite in ne drobite tablet.
English: If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are feeling normal again.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste po jemanju zdravila EXJADE omotični, ne vozite in ne upravljajte nobenih naprav ali strojev, dokler se ne počutite spet normalno.
English: Then add a little water or juice to what is left in the glass, swirl the liquid around and drink that too.
Slovenian: K preostanku dolijte malo vode ali soka, zavrtite tekočino v kozarcu in popijte še to.
English: o The need to consider renal biopsy:
Slovenian: o potrebnost razmisleka o ledvični biopsiji:
English: Other medicines and EXJADE
Slovenian: Druga zdravila in zdravilo EXJADE
English: Increase
Slovenian: zviševanje
English: The corresponding doses for the different formulations are shown in the table below.
Slovenian: V spodnji preglednici so prikazani ustrezni odmerki za različne formulacije.
English: The clinical study report should be submitted by
Slovenian: Poročilo klinične študije mora predložiti do roka:
English: • Serum creatinine remains significantly elevated and
Slovenian: • koncentracija kreatinina v serumu ostane pomembno zvišana in
English: As a consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
Slovenian: Posledično je treba zdravljenje z zdravilom EXJADE skrbno spremljati z namenom odkrivanja neželenih učinkov in slediti obremenitvi z železom pri pediatrični populaciji.
English: Do not swallow the tablets whole.
Slovenian: Ne pogoltnite celih tablet.
English: Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.
Slovenian: Raztapljanje v gaziranih pijačah ali mleku zaradi penjenja oziroma počasnega raztapljanja ni priporočljivo.
English: • Non-compliance of the posology and biological monitoring
Slovenian: • neupoštevanje priporočenega odmerjanja in biološkega spremljanja,
English: Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil.
Slovenian: Vrečice iz polietilentetraftalatne (PET)/aluminijske/polietilenske (PE) folije.
English: 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.
Slovenian: 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).
English: What EXJADE is and what it is used for
Slovenian: Kaj je zdravilo EXJADE in za kaj ga uporabljamo
English: The Guide for healthcare professionals shall contain the following key elements:
Slovenian: Priročnik za zdravstvene delavce mora navajati naslednje ključne vsebine:
English: The dispersible tablets are dispersed by stirring in a glass of water or orange or apple juice (100 to 200 ml) until a fine suspension is obtained.
Slovenian: Disperzibilne tablete se raztopijo z mešanjem v kozarcu vode ali pomarančnega ali jabolčnega soka (100 do 200 ml), dokler ne nastane fina suspenzija.
English: • Every week during the first month of initiation of treatment or after therapy modification
Slovenian: • vsak teden v prvem mesecu po uvedbi ali spremembi zdravljenja,
English: If this applies to you, tell your doctor before taking EXJADE.
Slovenian: Če to velja za vas, obvestite o tem svojega zdravnika še pred jemanjem zdravila EXJADE.
English: These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.
Slovenian: Ti učinki so odvisni od odmerka, večinoma so blagi do zmerni, v glavnem prehodnega značaja in večinoma izzvenijo tudi ob nadaljevanju zdravljenja.
English: Deferasirox is an orally active chelator that is highly selective for iron (III).
Slovenian: Deferasiroks je peroralno aktiven kelator, ki je visoko selektiven za trovalentno železo (III).
English: • Drop the tablet(s) into a glass of water, or apple or orange juice (100 to 200 ml).
Slovenian: • Spustite tableto/tablete v kozarec vode, jabolčnega ali pomarančnega soka (100 do 200 ml).
English: The tablets are white to slightly yellow, round and flat.
Slovenian: Tablete so bele do nekoliko rumenkaste, okrogle in ploščate.
English: In addition, before treating heavily iron-overloaded children with non-transfusion-dependent thalassaemia with EXJADE, the physician should be aware that the consequences of long-term exposure in such patients are currently not known.
Slovenian: Poleg tega se mora zdravnik pred začetkom zdravljenja otrok s težko preobremenitvijo z železom z zdravilom EXJADE zavedati, da posledice pri dolgotrajnem zdravljenju teh bolnikov trenutno niso znane.
English: If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, EXJADE should be interrupted.
Slovenian: V primeru persistentnega in progresivnega zvišanja koncentracij transaminaz v serumu, ki ga ni mogoče pripisati drugim vzrokom, je treba zdravljenje z zdravilom EXJADE prekiniti.
English: • Take EXJADE once a day, every day, at about the same time each day with some water.
Slovenian: • Vzemite zdravilo EXJADE enkrat na dan, vsakodnevno in sicer približno ob istem času, z nekaj vode.
English: • Stir until the tablet(s) dissolve completely.
Slovenian: • Mešajte, dokler se tableta/tablete popolnoma ne raztopi(jo).
English: EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over.
Slovenian: Zdravilo EXJADE se lahko uporablja pri otrocih in mladostnikih, ki prejemajo redne transfuzije krvi, starih 2 leti ali več, in pri otrocih in mladostnikih, ki ne prejemajo rednih transfuzij krvi, starih 10 let ali več.
English: Your doctor will calculate the dose you need and tell you how many sachets to take each day.
Slovenian: Vaš zdravnik bo izračunal odmerek, ki ga potrebujete, in vam bo povedal koliko vrečic boste vzeli vsak dan.
English: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using EXJADE.
Slovenian: Priporočeno je, da ženske v rodni dobi v času uporabe zdravila EXJADE uporabljajo dodatne ali druge nehormonske metode kontracepcije.
English: • If you experience frequent abdominal pain, particularly after eating or taking EXJADE,
Slovenian: • če vas pogosto boli trebuh, posebno po uživanju hrane ali po jemanju zdravila EXJADE,
English: What you need to know before you take EXJADE
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo EXJADE
English: Show the doctor the pack of tablets.
Slovenian: Zdravniku pokažite škatlo zdravila.
English: Agents that may decrease EXJADE systemic exposure Deferasirox metabolism depends on UGT enzymes.
Slovenian: Zdravila, ki lahko zmanjšajo sistemsko izpostavljenost zdravilu EXJADE Presnova deferasiroksa je odvisna od encimov UGT.
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as EXJADE may reduce the effectiveness of oral and patch contraceptives.
Slovenian: Če trenutno za zaščito pred nosečnostjo uporabljate peroralne kontraceptive (kontracepcijske tablete) ali kontracepcijski obliž, morate uporabljati še dodatno zaščito ali drugo vrsto kontracepcije (na primer kondom), saj zdravilo EXJADE lahko zmanjša učinkovitost kontracepcijskih tablet in obližev.
English: Deferasirox 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.
Slovenian: Deferasiroks 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.
English: Prior to launch of deferasirox film-coated tablets, healthcare professionals will receive introductory notification letters as follows:
Slovenian: Pred prihodom deferasiroksa v obliki filmsko obloženih tablet na tržišče morajo zdravstveni delavci prejeti predstavitveni dopis, in sicer:
English: What EXJADE is and what it is used for What you need to know before you take EXJADE How to take EXJADE
Slovenian: Kaj je zdravilo EXJADE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo EXJADE Kako jemati zdravilo EXJADE Možni neželeni učinki
English: The film-coated tablets are ovaloid and biconvex.
Slovenian: Filmsko obložene tablete so ovalne oblike in so bikonveksne.
English: • Take the EXJADE dispersible tablets on an empty stomach.
Slovenian: • Disperzibilne tablete EXJADE vzemite na prazen želodec.
English: Table 4 Summary of safety monitoring recommendations
Slovenian: Preglednica 4 Povzetek varnostnih priporočil za spremljanje bolnika
English: White to almost white granules
Slovenian: zrnca v vrečici (zrnca) bela do skoraj bela zrnca
English: • The maximum recommended daily dose for EXJADE film-coated tablets is:
Slovenian: • Največji priporočeni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet je: