FrancophonIA/ELRC3.0 huggingface dataset:
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta in vključno z zeliščnimi pripravki ter vitamini.
English: In the 26-week study, moderate to marked diffuse seminiferous tubular atrophy was present at a very low incidence, whereas in the 99-week study there was a dose-related, slightly increased incidence of minimal to mild focal atrophy at doses providing 29 to 94 times the human exposure.
Slovenian: V raziskavi, ki je trajala 99 tednov, so opazili od odmerka odvisno rahlo zvišano pojavnost minimalne do blage žariščne atrofije, in sicer pri odmerkih, ki so ustrezali od 29- do 94-kratni izpostavitvi pri človeku.
English: Functional Class: A reduction in symptoms of PAH were observed with sitaxentan sodium 100 mg treatment.
Slovenian: Funkcionalni razred: Pri zdravljenju s 100 mg odmerkom natrijevega sitaksentanata so opazili zmanjšanje simptomov PAH.
English: INR increase (with concomitant vitamin K antagonist therapy).
Slovenian: Povečanje INR (med sočasnim zdravljenjem z antagonistom vitamina K).
English: Long-term survival:There are no randomised studies to demonstrate beneficial effects on survival of treatment with sitaxentan sodium.
Slovenian: Randomizirane raziskave, ki bi pokazale koristne učinke na preživetje zdravljenja z natrijevim sitaksentanatom, niso bile opravljene.
English: However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Slovenian: Vendar so poročali, da je pri uporabi vazodilatatorjev (v glavnem prostaciklina) pri teh bolnikih v posameznih primerih prišlo do življenjsko ogrožajočega pljučnega edema.
English: Common side effects (likely to affect more than 1 in every 100 people):
Slovenian: Pogosti neželeni učinki (se verjetno pojavijo pri več kot 1 od 100 bolnikov) so:
English: Omeprazole (substrate of CYP2C19): Concomitant administration of Thelin with omeprazole increased the omeprazole AUC0-24 by 30%; Cmax was unchanged.
Slovenian: Omeprazol (substrat CYP2C19): Sočasna uporaba zdravila Thelin z omeprazolom zviša AUC0-24 omeprazola za 30 %; Cmax se ne spremeni.
English: The following two blood tests will be carried out before you first take Thelin and at intervals during treatment
Slovenian: Preden boste prvič vzeli zdravilo Thelin, boste opravili naslednji dve preiskavi krvi in nato še v določenih časovnih presledkih med zdravljenjem.
English: Most of this decrease of haemoglobin concentration was detected during the first few weeks of treatment and haemoglobin levels stabilized by 4 weeks of Thelin treatment.
Slovenian: V večini primerov je bilo to znižanje koncentracije hemoglobina odkrito v prvih nekaj tednih zdravljenja.
English: In vitro studies using human liver microsomes or primary hepatocytes show that sitaxentan sodium inhibits CYP2C9, and, to a lesser extent, CYP 2C8, CYP2C19 and CYP3A4/5.
Slovenian: Podatki in vitro poskusov na človeških jetrnih mikrosomih ali primarnih hepatocitih kažejo, da natrijev sitaksentanat zavira CYP2C9 in v manjši meri tudi CYP 2C8, CYP2C19 ter CYP3A4/5.
English: Nausea, constipation, upper abdominal pain, vomiting, dyspepsia and diarrhoea
Slovenian: Bolezni prebavil Navzea, zaprtje, abdominalna bolečina, bruhanje, dispepsija in driska pogosti
English: ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension (PAH), as well as other cardiovascular disorders and connective tissue diseases, including scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension, and atherosclerosis, suggesting a pathogenic role of ET-1 in these diseases.
Slovenian: To opazimo tudi pri drugih srčno-žilnih boleznih in boleznih vezivnega tkiva, med drugim pri sklerodermi, akutnem in kroničnem srčnem popuščanju, miokardni ishemiji, sistemski hipertenziji in aterosklerozi, kar kaže na patogeno delovanje ET-1 pri teh boleznih.
English: Insomnia, dizziness
Slovenian: Nespečnost, omotica pogosti
English: Prothrombin time (PT) increase (with concomitant vitamin K antagonist therapy).
Slovenian: Podaljšanje protrombinskega časa (PČ) (med sočasnim zdravljenjem z antagonistom vitamina K).
English: • If you develop liver problems or symptoms that might relate to the liver (see ‘Testing for liver problems', below);
Slovenian: • Če se pri vas pojavijo težave z jetri ali simptomi, ki so povezani z jetri (glejte poglavje
English: Thelin 100 mg film-coated tablets Sitaxentan sodium
Slovenian: Thelin 100 mg filmsko obložene tablete natrijev sitaksentanat
English: Each film-coated tablet contains 100 mg sitaxentan sodium.
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg natrijevega sitaksentanata.
English: In patients already taking a vitamin K antagonist, it is recommended that the dose of the vitamin K antagonist be reduced when starting sitaxentan sodium.
Slovenian: Pri bolnikih, ki že jemljejo antagonist vitamina K, je priporočljivo, da se ob uvedbi natrijevega sitaksentanata zniža odmerek antagonista vitamina K. V vseh primerih je potrebno INR redno preverjati.
English: Elevations of AST and/or ALT associated with Thelin occur both early and late in treatment, usually progress slowly, and are typically asymptomatic.
Slovenian: Zvišane vrednosti AST in/ali ALT, ki so povezane z zdravilom Thelin, se pojavijo zgodaj in pozno v poteku zdravljenja.
English: Large / abnormally shaped livers, a delay in auditory function development, a delay in preputial separation and a reduction in the number of embryonic implants occurred at higher maternal doses.
Slovenian: Visoki odmerki pri materi so povzročili velika/nenormalno oblikovana jetra, kasnejši razvoj sluha, kasnejše ločevanje prepucija in zmanjšanje števila vsajenih zarodkov.
English: The overall mean decrease in haemoglobin concentration for Thelin -treated patients was 0.5 g/dl (change to end of treatment).
Slovenian: Znižane vrednosti hemoglobina (glejte poglavje 4.4) Skupno povprečno znižanje koncentracij hemoglobina pri bolnikih, ki so prejemali zdravilo Thelin, je bilo za 0,5 g/dl (sprememba do zaključka zdravljenja).
English: If any of these apply to you, tell your doctor before you start taking Thelin.
Slovenian: Obvestite svojega zdravnika, če katerikoli primer velja za vas, preden začnete jemati zdravilo Thelin.
English: Haemodynamic parameters: These were assessed in STRIDE-1 for both functional class II and III patients.
Slovenian: V STRIDE-1 so ocenjevali hemodinamične parametre za bolnike II.
English: Cases of concurrent elevations of transaminases (ALT and/or AST) > 8 x ULN and total bilirubin > 2 x ULN have been reported following administration of sitaxentan sodium.
Slovenian: Po uporabi natrijevega sitaksentanata so poročali o primerih sočasne zvišane vrednosti transaminaz (ALT in/ali AST) > 8 × ZMN in celotnega bilirubina > 2 × ZMN.
English: Sildenafil (substrate of CYP3A4): A single dose of sildenafil 100 mg coadministered with Thelin increased Cmax and AUC∞ of sildenafil by 18% and 28%, respectively.
Slovenian: Sildenafil (substrat CYP3A4): Enojen odmerek 100 mg sildenafila sočasno z zdravilom Thelin je povzročil zvišanje Cmax sildenafila za 18 % in AUC∞ sildenafila za 28 %.
English: The 18 week STRIDE-2 trial, conducted in 246 patients, included 4 treatment arms: placebo once daily, Thelin 50 mg once daily, Thelin 100 mg once daily, and open-label bosentan twice daily (efficacy-rater blinded, administered according to the approved package insert).
Slovenian: V preskušanju STRIDE-2, kjer je bilo vključenih 246 bolnikov in je trajalo 18 tednov, so primerjali 4 skupine bolnikov: bolnike, ki so jemali placebo enkrat dnevno; bolnike, ki so jemali zdravilo Thelin 50 mg enkrat dnevno; bolnike, ki so jemali zdravilo Thelin 100 mg enkrat dnevno; bolnike, ki so jemali bosentan dvakrat dnevno (v zadnji skupini so bolniki vedeli, katero zdravilo prejemajo, ne pa tudi ocenjevalci učinkovitosti; bosentan je bil uporabljen po navodilu za uporabo).
English: Elevations in ALT values > 5 ULN were 4% (36/887) for sitaxentan 100 mg QD and 0.6% in the placebo group (1/155).
Slovenian: Zvišanje vrednosti ALT > 5 ZMN so opazili pri 4 % (36/887) bolnikov, ki so prejemali sitaksentan 100 mg enkrat dnevno in pri 0,6 % bolnikov, ki so prejemali placebo (1/155).
English: If the aminotransferase levels return to pre-treatment values, consider resuming the initial treatment schedule according to the conditions described below.
Slovenian: Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, razmislite o nadaljevanju začetne sheme zdravljenja v skladu z pogoji, ki so opisani spodaj.
English: • If any side effect becomes serious, or if you notice any side effects not listed in this leaflet,
Slovenian: • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: In repeated-dose toxicity studies, dose-related liver changes (weight, centrilobular hypertrophy, occasionally necrosis), induction of hepatic drug metabolising enzymes and slightly decreased erythron parameters were seen in mice, rats and dogs.
Slovenian: Pri miših, podganah in psih so v raziskavah toksičnosti ponavljajočega odmerka opazili spremembe jeter v odvisnosti od odmerka (masa, cetrilobularna hipertrofija, posamezni primeri nekroze), indukcijo jetrnih encimov, ki presnavljajo zdravila, in rahlo znižane parametre eritrona.
English: There is limited experience with abrupt discontinuation of sitaxentan sodium.
Slovenian: Izkušenj z nenadno prekinitvijo zdravljenja z natrijevim sitaksentanatom je malo.
English: There is an increased risk of bleeding with Thelin, mainly in the form of epistaxis and gingival bleeding.
Slovenian: Pri jemanju zdravila Thelin se poveča tveganje za krvavitve, ki se večinoma kažejo kot krvavitve iz nosa in krvavitve iz dlesni.
English: Therefore, caution is recommended in case of co-administration.
Slovenian: Zato je priporočljiva previdnost, če se sočasno dajejo druga zdravila.
English: Pre-existing liver impairment
Slovenian: Obstoječa jetrna okvara
English: > 3 and ≤ 5 x ULN: Confirm by another liver test;if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
Slovenian: > 3 in ≤ 5 × ZMN: Potrdite z drugo preiskavo jeter; če je stanje potrjeno, se morate odločiti za nadaljevanje ali prekinitev zdravljenja z zdravilom Thelin za vsakega bolnika posebej.
English: Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin > 2 x ULN prior to initiation of treatment (see section 4.3).
Slovenian: Zdravilo Thelin je kontraindicirano za zdravljenje bolnikov, ki imajo pred začetkom zdravljenja zvišane vrednosti jetrnih aminotransferaz (> 3 × zgornja meja normalne vrednosti (ZMN)) ali, ki imajo pred začetkom zdravljenja zvišano vrednost direktnega bilirubina >2 × ZMN (glejte poglavje 4.3).
English: Stearic acid (E570b) Hypromellose (E464) Cellulose, microcrystalline (E460) Titanium dioxide (E171) Yellow iron oxide dehydrate (E172) Red iron oxide dehydrate (E172) Talc (E553b)
Slovenian: Stearinska kislina (E570b) Hipromeloza (E464) Celuloza, mikrokristalna (E460) Titanov dioksid (E171) Rumeni železov oksid dihidrat (E172) Rdeči železov oksid dihidrat (E172) Smukec (E553b)
English: Fluconazole (inhibitor of CYP2C19, CYP2C9 and CYP3A4/5): Co-administration of Thelin and fluconazole had no effect on the clearance of sitaxentan sodium.
Slovenian: Flukonazol (zaviralec CYP2C19, CYP2C9 in CYP3A4/5): Sočasna uporaba zdravila Thelin in flukonazola ni vplivala na očistek natrijevega sitaksentanata.
English: PVC/ACLAR/paper-backed aluminium blisters
Slovenian: Pretisni omoti iz aluminija in s podlago iz PVC/ACLAR/papirja
English: However, sitaxentan sodium did not affect the anti-ovulatory activity of the oral contraceptive as assessed by the plasma concentrations of follicle stimulating hormone (FSH), luteinising hormone (LH), and progesterone (see section 4.4).
Slovenian: Vendar, ocenjeno po plazemskih koncentracijah folikl stimulirajočega hormona (FSH), luteinizirajočega hormona (LH) in progesterona, natrijev sitaksentanat ni vplival na antiovulacijsko delovanje peroralnega kontraceptiva (glejte poglavje 4.4).
English: Median Difference from Placebo (95% CI)
Slovenian: Srednja vrednost razlike glede na placebo p-vrednost PVR (din*s/cm
English: Testing for anaemia
Slovenian: Preiskave za slabokrvnost
English: >3 and ≤ 5 x ULN: Confirm by another liver test; if confirmed, a decision should be made on an individual basis to continue or to stop Thelin administration.
Slovenian: > 3 in ≤ 5 × ZMN Potrdite z drugo preiskavo jeter; če je stanje potrjeno, se morate odločiti za nadaljevanje ali prekinitev zdravljenja z zdravilom Thelin za vsakega bolnika posebej.
English: • feeling sick (nausea)
Slovenian: • slabost (navzeja),
English: In vitro, sitaxentan sodium is metabolized by CYP2C9 and CYP3A4/5.
Slovenian: V in vitro pogojih natrijev sitaksentanat presnavljata CYP2C9 in CYP3A4/5.
English: Organic Anion Transporting Polypeptides (OATP) Inhibitors: Co-administration with ciclosporin A, a potent OATP inhibitor, resulted in a 6-fold increase in Cmin and a 67% increase in AUC of sitaxentan therefore the use of Thelin in patients receiving systemic ciclosporin A is contraindicated (see section 4.3).
Slovenian: Zaviralci OATP - polipetpdidov za prenos organskih anionov: Sočasna uporaba ciklosporina A, ki je močan zaviralec OATP, je povzročila 6-kratno povečanje Cmin in 67 % povečanje AUC sitaksentana.
English: Nifedipine (substrate of CYP3A4/5): The clearance of nifedipine was not clinically significantly changed when given concomitantly with Thelin.
Slovenian: Nifedipin (substrat CYP3A4/5): Očistek nifedipina se med sočasno uporabo z zdravilom Thelin ni klinično pomembno spremenil.
English: Drugs which inhibit Organic Anion Transporting Polypeptides (OATP) The extent of interaction with potent OATP inhibitors (e.g. some statins, proteinase inhibitors, tuberculostatics) is unknown.
Slovenian: Obseg interakcije z močnimi zaviralci OATP (npr. statini, zaviralci proteaz, tuberkulostatiki) ni znan.
English: You may need to take Thelin for a month or two before feeling any effect.
Slovenian: Ne vzemite več kot ene tablete na dan. Preden boste začutili učinek, boste morda morali jemati zdravilo Thelin en mesec ali dva.
English: • If you are taking or begin to take anticoagulants (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione) to prevent blood clots.
Slovenian: • Če jemljete ali ste začeli jemati zdravila proti strjevanju krvi (npr. varfarin, acenokumarol,
English: Sitaxentan
Slovenian: sitaksentanat
English: • The film-coat contains stearic acid (E570b), hypromellose (E464), microcrystalline cellulose (E460), titanium dioxide (E171), yellow iron oxide dehydrate (E172), red iron oxide dehydrate (E172) and talc (E553b).
Slovenian: • Filmska obloga vsebuje stearinsko kislino (E570b), hipromelozo (E464), mikrokristalno celulozo (E460), titanov dioksid (E171), rumeni železov oksid dihidrat (E172), rdeči železov oksid dihidrat (E172) in smukec (E553b).
English: Treatment must not be initiated in women of child-bearing potential unless they practice reliable contraception, due to possible teratogenicity.
Slovenian: Zaradi možne teratogenosti se zdravljenje ne sme uvajati pri ženskah v rodni dobi, če ne uporabljajo zanesljive kontracepcije.
English: Your doctor will take blood tests to check that your liver is working properly, before and during treatment with Sitaxentan sodium.
Slovenian: Zdravnik bo pred zdravljenjem z natrijev sitaksentanat in med zdravljenjem opravil preiskave krvi, da preveri, ali vaša jetra delujejo pravilno.
English: If the aminotransferase levels return to pre-treatment values, consider reintroducing Thelin according to the conditions described below.
Slovenian: Če se vrednosti aminotransferaz vrnejo na vrednosti pred zdravljenjem, preučite možnost ponovnega zdravljenja z zdravilom Thelin pod pogoji, ki so opisani spodaj.
English: What Thelin tablets look like and contents of the pack Thelin 100 mg film-coated tablets are yellow-to-orange, capsule-shaped tablets, marked with T-100 on one side.
Slovenian: Thelin 100 mg filmsko obložene tablete so rumene do oranžne barve v obliki kapsule z napisom T-100 na eni strani.
English: Metabolism and Elimination
Slovenian: Presnova in izločanje
English: Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Slovenian: Če se klinično stanje poslabša, morate preučiti možnosti zamenjave zdravljenja z zdravljenjem, ki je priporočeno za hudo stopnjo bolezni (npr. epoprostenol) (glejte poglavje 4.2).
English: Dosage in hepatic impairment:
Slovenian: Bolniki z jetrno okvaro:
English: Thelin increases oestrogen exposure when given concomitantly with oral contraceptive agents (see Section 4.5).
Slovenian: Pri sočasni uporabi s peroralnimi kontracepcijskimi sredstvi Thelin poveča izpostavitev estrogenu (glejte poglavje 4.5).
English: Plasma concentrations of drugs principally metabolized by CYP2C9 may be increased during sitaxentan sodium co-administration.
Slovenian: Med sočasnim zdravljenjem z natrijevim sitaksentanatom se lahko zvišajo plazemske koncentracije zdravil, ki jih presnavlja CYP2C9.
English: • The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate (E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339).
Slovenian: • Jedro tablete vsebuje mikrokristalno celulozo (E460), laktozo monohidrat, hipromelozo (E464), natrijev škrobni glikolat, magnezijev stearat (E470b), brezvodni natrijev hidrogenfosfat (E339), askorbilpalmitat (E304), dinatrijev edetat in natrijev dihidrogenfosfat (E339).
English: HOW TO STORE THELIN
Slovenian: SHRANJEVANJE ZDRAVILA THELIN
English: Each tablet contains 100 mg of sitaxentan sodium
Slovenian: Ena tableta vsebuje 100 mg natrijevega sitaksentanata.
English: STRIDE-4 included 98 patients randomised to sitaxentan sodium 50 mg, 100 mg, and placebo once daily for 18 weeks.
Slovenian: V randomiziranem preskušanju STRIDE-4, kjer je bilo vključenih 98 bolnikov in je trajalo 18 tednov, so primerjali bolnike, ki so enkrat dnevno jemali natrijev sitaksentanat 50 mg, 100 mg ali placebo.
English: Ketoconazole (substrate and inhibitor of CYP3A4/5): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or ketoconazole.
Slovenian: Ketokonazol (substrat in zaviralec CYP3A4/5): Sočasna uporaba z zdravilom Thelin ni klinično pomembno spremenila očistka natrijevega sitaksentanata in ketokonazola.
English: Respiratory, thoracic, and mediastinal disorders Nasal congestion, epistaxis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Zamašenost nosu, epistaksa pogosti
English: Sitaxentan sodium is an inhibitor of CYP2C9 and, to a lesser extent, CYP2C19, CYP3A4/5 and CYP2C8.
Slovenian: Natrijev sitaksentanat se v jetrih presnavlja z izoencimi CYP2C9 in CYP3A4/5 citokroma P450.Natrijev sitaksentanat je zaviralec CYP2C9 in v manjši meri tudi CYP2C19, CYP3A4/5 ter CYP2C8.
English: Thelin is to be taken orally as a dose of 100 mg once daily.
Slovenian: Thelin se jemlje peroralno v odmerku 100 mg enkrat na dan. Lahko se jemlje s hrano ali brez.
English: • That Thelin is hepatotoxic o Need for liver function tests prior to and during treatment o Contraindication in patients with pre-existing hepatic impairment (Child-Pugh Class A-C).
Slovenian: • da je zdravilo Thelin hepatotoksično o Potrebno je preverjati delovanje jeter pred in med zdravljenjem.
English: • unusual tiredness
Slovenian: • nenavadna utrujenost,
English: Nelfinavir (substrate of CYP3A4/5, CYP2C19): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or nelfinavir.
Slovenian: Nelfinavir (substrat CYP3A4/5, CYP2C19): Sočasna uporaba z zdravilom Thelin ni klinično pomembno spremenila očistka natrijevega sitaksentanata in nelfinavirja.
English: Gingival bleeding, flushing
Slovenian: Krvavitev iz dlesni, zardevanje pogosti
English: o Need for close monitoring if liver enzymes measure > 3 × upper limit normal (ULN):
Slovenian: o Če so jetrni encimi ≥ 3 × zgornje meje normalne vrednosti (ZMN), je potrebno bolnika natančno spremljati.
English: The clearance of nelfinavir was not clinically significantly changed in one subject that was classified as a CYP2C19 poor metaboliser.
Slovenian: Pri enem preiskovancu, ki je bil uvrščen med slabe metabolizatorje s CYP2C19, se očistek nelfinavirja ni klinično pomembno spremenil.
English: No evidence for acute rebound has been observed.
Slovenian: Ni opaženih dokazov o akutnem poslabšanju na prvotno stanje bolezni.
English: Endothelin receptor antagonists, as a class, have been associated with liver function abnormalities.
Slovenian: Te nenormalnosti so povezane z antagonisti receptorja za endotelin.
English: • your blood may take longer to clot.
Slovenian: • počasnejše strjevanje krvi.
English: • swelling in the arms and legs
Slovenian: • otekanje rok in nog,
English: • That Thelin is teratogenic o Use of effective contraception in women of child bearing age o Possible interaction with oral contraceptives and increased risk of thromboembolism o Need to advise female patients about teratogenicity, contraception, if necessary the need for pregnancy testing and what to do if they become pregnant o Referral of patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice
Slovenian: o Bolnice, ki zanosijo, je potrebno napotiti k specialistu za teratogenost ali zdravniku, ki ima izkušnje na področju teratogenosti, ter prositi zdravnika za diagnozo, drugo mnenje in nasvet.
English: Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) Disodium edetate
Slovenian: Natrijev karboksimetilškrob Magnezijev stearat (E470b) Natrijev hidrogenfosfat, brezvodni (E339) Askorbilpalmitat (E304) Dinatrijev edetat
English: Always take Thelin exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Thelin natančno upoštevajte zdravnikova navodila.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Thelin in vsebina pakiranja
English: BEFORE YOU TAKE THELIN
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO THELIN
English: • flushed
Slovenian: • rdečica,
English: (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: >8 x ULN: treatment must be stopped and reintroduction of Thelin is not to be considered.
Slovenian: Zdravljenje je treba končati, ponovna uvedba zdravila Thelin pa ne pride v poštev.
English: (twice daily)
Slovenian: (dvakrat na dan)
English: Take the tablets morning and evening as prescribed by your doctor.
Slovenian: • Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
English: • if you are or become dehydrated
Slovenian: • ste ali postanete dehidrirani,
English: • Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
Slovenian: • Slabost: če izgubite tek in je količina hrane, ki jo dnevno zaužijete, mnogo manjša kot ponavadi.
English: PRIMARY ANALYSIS
Slovenian: OSNOVNA ANALIZA
English: It is important that you take all your medicine as prescribed by your doctor.
Slovenian: • Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal zdravnik.
English: • if you have a history of eye problems as you may need extra monitoring of your eyes
Slovenian: • ste v preteklosti imeli bolezni oči, ker boste morda potrebovali dodatne kontrole oči,