FrancophonIA/ELRC3.0 huggingface dataset:
English: haematological abnormalities including neutropenia, leucopenia, anaemia, thrombocytopenia, pancytopenia, aplastic anaemia, agranulocytosis.
Slovenian: hematološke nepravilnosti, vključno z nevtropenijo, levkopenijo, anemijo, trombocitopenijo, pancitopenijo, aplastično anemijo in agranulocitozo.
English: 700 mg/day has been required by some patients to achieve desired response
Slovenian: Nekateri bolniki so za želeni odziv potrebovali 700 mg/dan.
English: Lamotrigine 2 mg tablets are the lowest strength available, therefore the standard dosing schedule was adapted in some cases during the titration phase (for example, by administering a 2 mg tablet on alternate days when the calculated dose was less than 2 mg).
Slovenian: Zato so standardni razpored odmerjanja v nekaterih primerih med obdobjem titriranja prilagodili (npr. z uporabo ene 2 mg tablete vsak drugi dan, če je bil izračunani odmerek manjši od 2 mg).
English: UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine.
Slovenian: Ugotovljeno je, da so za presnovo lamotrigina odgovorni encimi UDP-glukuronil-transferaze.
English: Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase and could therefore theoretically lead to an increased risk of embryofoetal damage by reducing folic acid levels (see section 4.4).
Slovenian: Lamotrigin rahlo zavira dihidrofolat-reduktazo in bi tako lahko z zmanjšanjem koncentracije folne kisline teoretično povzročil tveganje za embrio-fetalno okvaro (glejte poglavje 4.4).
English: Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods; see sections 4.4 and 4.5).
Slovenian: Zato morajo imeti pri izbiri kontracepcije prednost načini, ki ne vključujejo tedna brez tablet (npr. stalni hormonski kontraceptivi ali nehormonski načini; glejte poglavji 4.4 in 4.5).
English: Effect of lamotrigine on hormonal contraceptive pharmacokinetics In a study of 16 female volunteers, a steady state dose of 300 mg lamotrigine had no effect on the pharmacokinetics of the ethinyloestradiol component of a combined oral contraceptive pill.
Slovenian: Vpliv lamotrigina na farmakokinetiko hormonskih kontraceptivov V študiji 16 prostovoljk, odmerek 300 mg lamotrigina v stanju dinamičnega ravnovesja ni vplival na farmakokinetiko etinilestradiola v kombinirani kontracepcijski tableti.
English: A modest increase in oral clearance of the levonorgestrel component was observed, resulting in an average 19% and 12% reduction in levonorgestrel AUC and Cmax, respectively.
Slovenian: Ugotovili so zmerno povečanje peroralnega očistka levonorgestrela, kar je povzročilo povprečno 19 % zmanjšanje AUC in povprečno 12 % zmanjšanje Cmax levonorgestrela.
English: Musculoskeletal and connective tissue disorders Very rare:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Zelo redki:
English: Lamictal can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome.
Slovenian: Zdravilo Lamictal se lahko jemlje skupaj z drugimi zdravili tudi za zdravljenje napadov krčev, ki se pojavljajo pri motnji, imenovani Lennox-Gastautov sindrom.
English: Multiple oral doses of lamotrigine 400 mg daily had no clinically significant effect on the single dose pharmacokinetics of 2 mg risperidone in 14 healthy adult volunteers.
Slovenian: Večkratni peroralni odmerki lamotrigina 400 mg na dan pri 14 zdravih odraslih prostovoljcih niso klinično pomembno vplivali na farmakokinetiko risperidona po posamičnem odmerku 2 mg.
English: Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5).
Slovenian: Prenehanje uporabe hormonskih kontraceptivov pri bolnicah, ki že jemljejo vzdrževalne odmerke lamotrigina in NE jemljejo induktorjev glukuronidacije lamotrigina Vzdrževalni odmerek lamotrigina je večinoma treba znižatii, celo za 50 % (glejte poglavji 4.4 in 4.5).
English: As with other AEDs, abrupt withdrawal of Lamictal may provoke rebound seizures.
Slovenian: Kot velja za druge antiepileptike, lahko nenadna prekinitev Lamictala povzroči obratni odziv ("rebound") konvulzij.
English: The use of an ethinyloestradiol/levonorgestrel (30 µg/150 µg) combination increases the clearance of lamotrigine by approximately two-fold, resulting in decreased lamotrigine levels.
Slovenian: Uporaba kombinacije etinilestradiol/levonorgestrel (30 µg/150 µg) za približno dvakrat poveča očistek lamotrigina in tako zmanjša koncentracijo lamotrigina.
English: PVC/PVdC/aluminium foil blister.
Slovenian: Pretisni omot iz PVC/PVdC/aluminijske folije.
English: Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6).
Slovenian: Lamotrigin rahlo zavira dihidrofolat-reduktazo, zato med dolgotrajnim zdravljenjem obstaja možnost ovirane presnove folata (glejte poglavje 4.6).
English: The undesirable effects have been divided into epilepsy and bipolar specific sections based on the data currently available.
Slovenian: Glede na podatke, ki so trenutno na voljo, so neželeni učinki razdeljeni na specifični poglavji pri epilepsiji in bipolarni motnji.
English: Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods).
Slovenian: Zato morajo imeti prednost pri izbiri kontracepcije takšna zdravila, ki ne vključujejo tedna brez tablet (npr. stalni hormonski kontraceptivi ali nehormonske metode).
English: conjunctivitis.
Slovenian: konjunktivitis.
English: “After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on {Tradename} monotherapy”.
Slovenian: „Po doseženem nadzoru epilepsije med dopolnilnim zdravljenjem je mogoče prenehati s sočasno uporabo drugih antiepileptičnih zdravil (AED), zdravljenje bolnikov pa se nadaljuje kot monoterapija z zdravilom {trgovsko ime zdravila}“.
English: - The scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Slovenian: - namen napotitve je bila uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (Type A), iron oxide yellow (E172) and magnesium stearate.
Slovenian: Pomožne snovi so: laktoza monohidrat, mikrokristalna celuloza, povidon K30, natrijev karboksimetilškrob (tip A), rumeni železov oksid (E172) in magnezijev stearat.
English: PHARMACEUTICAL FORM AND CONTENTS 30 dispersible/chewable tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 disperzibilnih/žvečljivih tablet
English: A total of 256 subjects between 1 to 24 months of age have been exposed to lamotrigine in the dose range 1 to 15 mg/kg/day for up to 72 weeks.
Slovenian: Lamotriginu v odmerkih od 1 do 15 mg/kg/dan je bilo do 72 tednov izpostavljenih skupaj 256 preiskovancev, starih od 1 do 24 mesecev.
English: In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but reduced foetal weight and retarded skeletal ossification were observed, at exposure levels below or similar to the expected clinical exposure.
Slovenian: Raziskave reproduktivne in razvojne toksičnosti lamotrigina pri glodalcih in kuncih z odmerki, ki so bili nižji ali podobni pričakovani klinični izpostavitvi zdravilu, niso pokazale teratogenih učinkov, opazili pa so zmanjšanjo telesno težo zarodka in zapoznelo osifikacijo okostja .
English: Therefore in patients receiving concomitant therapy with oxcarbazepine, the treatment regimen for lamotrigine adjunctive therapy without valproate and without inducers of lamotrigine glucuronidation should be used (see section 4.2).
Slovenian: Zato je treba pri bolnikih, ki sočasno dobivajo okskarbazepin, uporabiti režim zdravljenja za dodatno zdravljenje z lamotriginom brez valproata in brez induktorjev glukuronidacije lamotrigina (glejte poglavje 4.2).
English: In women not already taking an inducer of lamotrigine glucuronidation and taking a hormonal contraceptive that includes one week of inactive treatment (for example "pill-free week"), gradual transient increases in lamotrigine levels will occur during the week of inactive treatment (see section 4.2).
Slovenian: Pri ženskah, ki ne prejemajo induktorja glukuronidacije lamotrigina in ki sočasno uporabljajo hormonske kontraceptive, se v tednu neaktivnega zdravljenja (npr. "teden brez tablete") koncentracija lamotrigina postopoma prehodno poveča (glejte poglavje 4.2).
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi raziskav farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Measurement of serum lamotrigine concentrations before and after starting hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained.
Slovenian: Priporočljivo je merjenje koncentracije lamotrigina v serumu pred začetkom uporabe hormonskih kontraceptivov in potem; tako se lahko prepričate, da se je vzdrževana koncentracija lamotrigina ohranila.
English: kidneys or blood, and may tell you to stop taking Lamictal.
Slovenian: Zdravnik bo morda naročil preiskave jeter, ledvic ali krvi, ali vam bo naročil, da nehate jemati Lamictal.
English: • double vision or blurred vision
Slovenian: • dvojen vid ali zamegljen vid
English: If epileptic control is achieved with adjunctive treatment, concomitant AEDs may be withdrawn and patients continued on Lamictal monotherapy.
Slovenian: Če je epilepsija z dodatnim zdravljenjem nadzorovana, lahko sočasno uporabo antiepileptikov ukinete in nadaljujete monoterapijo z Lamictalom.
English: • in people who already have Parkinson's disease, worsening of the symptoms.
Slovenian: • poslabšanje simptomov pri bolnikih, ki imajo Parkinsonovo bolezen
English: A decrease in lamotrigine levels has been associated with loss of seizure control.
Slovenian: Zmanjšana koncentracijo lamotrigina je bila povezana z izgubo nadzora nad epileptičnimi napadi.
English: The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation and multiorgan failure.
Slovenian: Sindrom se lahko kaže v širšem obsegu, je klinično resen, v redkih primerih lahko povzroči diseminirano intravaskularno koagulacijo in odpoved različnih organov.
English: No adjustments to the recommended dose escalation guidelines for lamotrigine should be necessary solely based on the use of hormonal contraceptives, but the maintenance dose of lamotrigine will need to be increased or decreased in most cases when starting or stopping hormonal contraceptives (see section 4.2).
Slovenian: Uporaba hormonskih kontraceptivov sama po sebi ne zahteva prilagoditve priporočenih smernic za zviševanje odmerka lamotrigina, večinoma pa je po začetku ali prenehanju jemanja hormonskih kontraceptivov treba zvišati ali znižati vzdrževalni odmerek lamotrigina (glejte poglavje 4.2).
English: nystagmus, tremor, insomnia.
Slovenian: nistagmus, tremor, nespečnost.
English: Starter pack of 21 or 42 tablets.
Slovenian: Začetno pakiranje z 21 ali 42 tabletami.
English: Apart from the indication in bipolar disorder the SPC of Lamictal in the different EU members show a large overlap.
Slovenian: Razen indikacije za bipolarno motnjo so si povzetki glavnih značilnosti za zdravilo Lamictal v različnih državah članicah EU zelo podobni.
English: • valproate, used to treat epilepsy and mental health problems
Slovenian: • valproat, ki se uporablja za zdravljenje epilepsije in težav z duševnim zdravjem,
English: There have been reports of adverse skin reactions, which have generally occurred within the first eight weeks after initiation of lamotrigine treatment.
Slovenian: Na splošno so se pojavili v prvih osmih tednih po začetku zdravljenja z lamotriginom.
English: Specialist advice should be given to women who are of childbearing potential.
Slovenian: Ženske v rodni dobi potrebujejo nasvet specialista.
English: 5 mg dispersible/chewable tablets - where 2 mg dispersible/chewable tablets are not marketed and 5 mg dispersible/chewable tablets are the lowest marketed strength: <It should be noted that with the currently available Lamictal 5 mg dispersible/chewable tablet strength, it is not possible to accurately initiate lamotrigine therapy using the recommended dosing guidelines in paediatric patients weighing less than 17 kg.>
Slovenian: 5 mg disperzibilne/žvečljive tablete - kjer 2 mg disperzibilnih/žvečljivih tablet ni na trgu in so 5-mg disperzibilne/žvečljive tablete najmanjša jakost na trgu: <S trenutno dostopno jakostjo, Lamictal 5 mg disperzibilnimi/žvečljivimi tabletami ni mogoče začeti natančnega zdravljenja z lamotriginom, kot narekujejo smernice za odmerjanje pri pediatričnih bolnikih, lažjih od 17 kg.>
English: 2 4 6 8 10 12 14 (no pocket)
Slovenian: 2 4 6 8 10 12 14 (brez žepka)
English: If you take more Lamictal than you should
Slovenian: Če ste vzeli večji odmerek zdravila Lamictal, kot bi smeli:
English: Mean half-life is reduced to approximately 14 hours when given with glucuronidation-inducing medicinal products such as carbamazepine and phenytoin and is increased to a mean of approximately 70 hours when co-administered with valproate alone (see section 4.2).
Slovenian: Povprečni razpolovni čas se skrajša na približno 14 ur, če je lamotrigin uporabljen sočasno z zdravili, ki inducirajo glukuronidacijo, npr. s karbamazepinom ali fenitoinom, in se podaljša povprečno za približno 70 ur, če je uporabljen sočasno z valproatom (glejte poglavje 4.2).
English: This dosage regimen should be used when the following are added without valproate:
Slovenian: Ta režim odmerjanja morate uporabiti, kadar dodate katerega od naslednjih zdravil brez uporabe valproata:
English: • carbamazepine, used to treat epilepsy and mental health problems
Slovenian: • karbamazepin, ki se uporablja za zdravljenje epilepsije in težav z duševnim zdravjem,
English: In patients receiving concomitant therapy with phenytoin, carbamazepine, pheonbarbitone or primidone, the appropriate treatment regimen should be used (see section 4.2).
Slovenian: Za bolnike, ki se sočasno zdravijo s fenitoinom, karbamazepinom, fenobarbitonom ali primidonom, morate uporabiti ustrezen režim zdravljenja (glejte poglavje 4.2).
English: Each dispersible/chewable tablet contains 2 mg, 5 mg, 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
Slovenian: Ena disperzibilna/žvečljiva tableta vsebuje 2 mg, 5 mg, 25 mg, 50 mg, 100 mg ali 200 mg lamotrigina.
English: - Monotherapy of typical absence seizures.
Slovenian: - Monoterapija pri tipičnih napadih odsotnosti.
English: 2 mg dispersible/chewable tablets - where this is the lowest marketed strength: <* If the calculated daily dose in patients taking valproate is 1 mg or more but less than 2 mg, then Lamictal 2 mg dispersible/chewable tablets may be taken on alternate days for the first two weeks.
Slovenian: 2 mg disperzibilne/žvečljive tablete - kjer je to najmanjša jakost na trgu: <* Če je izračunani dnevni odmerek za bolnike, ki jemljejo valproat, 1 mg ali več, toda manj kot 2 mg, lahko bolnik prva dva tedna dobiva Lamictal 2 mg disperzibilne/žvečljive tablete vsak drugi dan.
English: 8 9 10 11 12 13 14 (1 pocket)
Slovenian: 8 9 10 11 12 13 14 (1 žepek)
English: The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamictal.
Slovenian: Občasno se lahko med jemanjem zdravila Lamictal napadi krčev pri nekaterih vrstah epilepsije poslabšajo ali postanejo pogostejši.
English: During the pill-free week, a two-fold increase in lamotrigine levels has been observed.
Slovenian: V tednu brez hormonskih tablet so opazili dvakrat višjo koncentracijo lamotrigina.
English: Free of mania p-value Log rank test
Slovenian: Brez manije p vrednost (log-rank test)
English: Allergic reaction or potentially serious skin reaction: get a doctor's help straight away A small number of people taking Lamictal get an allergic reaction or potentially serious skin reaction, which may develop into more serious, and even life-threatening, problems if they are not treated.
Slovenian: Maloštevilnim bolnikom se lahko med jemanjem zdravila Lamictal pojavi alergijska reakcija ali potencialno resna kožna reakcija, ki se lahko razvije v še resnejšo in celo smrtno nevarno, če ni zdravljena.
English: Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Slovenian: Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN Velika Britanija
English: 10 dispersible/chewable tablets 14 dispersible/chewable tablets 28 dispersible/chewable tablets 30 dispersible/chewable tablets 50 dispersible/chewable tablets 56 dispersible/chewable tablets
Slovenian: 10 disperzibilnih/žvečljivih tablet 14 disperzibilnih/žvečljivih tablet 28 disperzibilnih/žvečljivih tablet 30 disperzibilnih/žvečljivih tablet 50 disperzibilnih/žvečljivih tablet 56 disperzibilnih/žvečljivih tablet
English: • clumsiness and lack of co-ordination (ataxia)
Slovenian: • okornost in pomanjkljiva usklajenost gibov (ataksija)
English: Effect of hormonal contraceptives on lamotrigine pharmacokinetics In a study of 16 female volunteers, dosing with 30 µg ethinyloestradiol/150 µg levonorgestrel in a combined oral contraceptive pill caused an approximately two-fold increase in lamotrigine oral clearance, resulting in an average 52% and 39% reduction in lamotrigine AUC and Cmax, respectively.
Slovenian: Vpliv hormonskih kontraceptivov na farmakokinetiko lamotrigina V študiji 16 prostovoljk je uporaba kombiniranih kontracepcijskih tablet s 30 µg etinilestradiola/150 µg levonorgestrela povzročila približno dvakratno povečanje očistka peroralnega lamotrigina, to pa je povzročilo povprečno 52 % zmanjšanje AUC in povprečno 39 % zmanjšanje Cmax lamotrigina.
English: 10 dispersible/chewable tablets 30 dispersible/chewable tablets 50 dispersible/chewable tablets 56 dispersible/chewable tablets 60 dispersible/chewable tablets 90 dispersible/chewable tablets 100 dispersible/chewable tablets 200 dispersible/chewable tablets
Slovenian: 10 disperzibilnih/žvečljivih tablet 30 disperzibilnih/žvečljivih tablet 50 disperzibilnih/žvečljivih tablet 56 disperzibilnih/žvečljivih tablet 60 disperzibilnih/žvečljivih tablet 90 disperzibilnih/žvečljivih tablet 100 disperzibilnih/žvečljivih tablet 200 disperzibilnih/žvečljivih tablet
English: 42 tablets
Slovenian: 42 tablet
English: Lamictal should not be administered to patients currently being treated with any other preparation containing lamotrigine without consulting a doctor.
Slovenian: Bolniki, ki jemljejo druga zdravila, ki vsebujejo lamotrigin, zdravila Lamictal ne smejo prejeti brez posveta z zdravnikom.
English: Starter pack of 42 tablets.
Slovenian: Začetno pakiranje z 42 tabletami.
English: • Swallow your tablets whole.
Slovenian: • Tablete pogoltnite cele.
English: Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg lamotrigine.
Slovenian: Ena tableta vsebuje 25 mg, 50 mg, 100 mg ali 200 mg lamotrigina.
English: Medicinal products that significantly induce glucuronidation of lamotrigine
Slovenian: Zdravila, ki pomembno inducirajo glukuronidacijo lamotrigina
English: The other ingredients are: calcium carbonate, low substituted hydroxypropyl cellulose, aluminium magnesium silicate, sodium starch glycolate (Type A), povidone K30, saccharin sodium, magnesium stearate, blackcurrant flavour.
Slovenian: Pomožne snovi so: kalcijev karbonat, delno substituirana hidroksipropilceluloza, aluminijev magnezijev silikat, natrijev karboksimetilškrob (tip A), povidon K30, natrijev saharinat, magnezijev stearat, okus črnega ribeza.
English: Depression free p-value Log rank test
Slovenian: Brez depresije p vrednost (log-rank test)
English: Effects of hormonal contraceptives on lamotrigine efficacy The use of an ethinyloestradiol/levonorgestrel (30 µg/150 µg) combination increases the clearance of lamotrigine by approximately two-fold resulting in decreased lamotrigine levels (see section 4.5).
Slovenian: Vpliv hormonskih kontraceptivov na učinkovitost lamotrigina Uporaba kombinacije etinilestradiol/levonorgestrel (30 µg/150 µg) za približno dvakrat poveča očistek lamotrigina in tako zmanjša koncentracijo lamotrigina (glejte poglavje 4.5).
English: **Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver.
Slovenian: **O izpuščaju so poročali tudi kot o delu preobčutljivostnega sindroma, ki ga spremljajo različne kombinacije sistemskih simptomov, vključno z zvišano telesno temperaturo, limfadenopatijo, edemom obraza in nepravilnostmi krvi in jeter.
English: In women who wish to stop taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle.
Slovenian: Če ženska želi prenehati uporabljati hormonski kontraceptiv, ki vključuje teden brez učinkovin ("teden brez tablet"), je treba koncentracijo lamotrigina v serumu kontrolirati v 3. tednu uporabe učinkovin, tj. od 15. do 21. dneva ciklusa kontracepcijskih tablet.
English: The undesirable effects below should be considered alongside those seen in epilepsy for an overall safety profile of lamotrigine.
Slovenian: Za celotno oceno varnosti lamotrigina morate poleg spodaj naštetih neželenih učinkov upoštevati tudi tiste, ki se pojavljajo pri epilepsiji.
English: tiredness.
Slovenian: driska.
English: In women taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i.e. on days 15 to 21 of the pill cycle.
Slovenian: Če ženska uporablja hormonski kontraceptiv, ki vključuje teden brez učinkovin ("teden brez tablet"), je treba koncentracijo lamotrigina v serumu kontrolirati v 3. tednu uporabe učinkovin, tj. od 15. do 21. dneva ciklusa kontracepcijskih tablet.
English: nausea, vomiting.
Slovenian: navzeja, bruhanje.
English: Lamictal can cause dizziness and double vision.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Lamictal lahko povzroči omotico in dvojen vid.
English: For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients' concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z ledvično odpovedjo v zadnji fazi morajo začetni odmerki lamotrigina temeljiti na sočasni uporabi drugih zdravil; pri bolnikih s pomembno okvarjenim delovanjem ledvic pa so lahko učinkoviti že nižji vzdrževalni odmerki (glejte poglavji 4.4 in 5.2).
English: 150 mg/day Maintain this dose (150 mg/day)
Slovenian: 150 mg/dan Vzdržujte ta odmerek (150 mg/dan)
English: Because of the risk of rash the initial dose and subsequent dose escalation should not be exceeded (see section 4.4).
Slovenian: Zaradi tveganja za pojav izpuščaja začetnega odmerka in kasnejšega zviševanja odmerka ne smete prekoračiti (glejte poglavje 4.4).