FrancophonIA/ELRC3.0 huggingface dataset:
English: These changes are secondary to the mechanism of action of lomitapide.
Slovenian: Te spremembe so posledica mehanizma delovanja lomitapida.
English: • To evaluate the long-term effectiveness of lomitapide in maintaining control of serum lipid levels in clinical practice.
Slovenian: • Oceniti dolgotrajno učinkovitost lomitapida pri vzdrževanju ravni lipidov v serumu v klinični praksi.
English: In animal studies lomitapide was highly concentrated (200-fold) in the liver.
Slovenian: V študijah na živalih je bil lomitapid izjemno koncentriran (200-kratno) v jetrih.
English: • if you are pregnant, trying to get pregnant, or think you may be pregnant (see section 2 under ‘Pregnancy and breast-feeding').
Slovenian: • če ste noseči, načrtujete zanositev ali menite, da bi lahko bili noseči (glejte poglavje 2 „Nosečnost in dojenje“).
English: • To lower the chance of stomach problems, you must stay on a low-fat diet whilst taking this medicine.
Slovenian: • Da zmanjšate možnost želodčnih težav, morate med jemanjem tega zdravila vzdrževati dieto z majhnim vnosom maščob.
English: Doses higher than 60 mg suggest a trend toward nonlinearity and are not recommended.
Slovenian: Odmerki, večji od 60 mg, kažejo nelinearnost in niso priporočljivi.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serij
English: The liver enzyme changes can occur at any time during therapy, but occur most often during dose escalation.
Slovenian: Spremembe jetrnih encimov se lahko pojavijo kadarkoli med zdravljenjem, vendar najpogosteje med povečevanjem odmerka.
English: • Do not take this medicine with food, as taking these capsules with food can cause stomach problems.
Slovenian: • Tega zdravila ne jemljite skupaj s hrano, saj lahko povzroči želodčne težave.
English: Median presented for TG and Lp(a).
Slovenian: a Mediana, predstavljena za TG in Lp(a).
English: In the renal impairment population, lomitapide was only studied in patients with end-stage renal disease (ESRD).
Slovenian: Glede populacije z ledvično okvaro se je lomitapid preučeval samo pri bolnikih z ledvično boleznijo v končnem stadiju (ESRD).
English: Effects on lomitapide levels
Slovenian: Učinki na ravni lomitapida
English: The physician educational pack should contain:
Slovenian: Izobraževalni komplet za zdravnike mora vsebovati:
English: Frequency of the adverse reactions is defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lojuxta in one or more subsets of the paediatric population in HoFH (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Lojuxta za eno ali več podskupin pediatrične populacije pri HoFH (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: (dehydration)
Slovenian: (dehidracija).
English: These capsules should be given to you by a doctor experienced in the treatment of lipid disorders who will also monitor you regularly.
Slovenian: Te kapsule vam mora predpisati zdravnik z izkušnjami z zdravljenjem lipidnih motenj, ki vas bo redno spremljal.
English: Following intravenous administration, the volume of distribution of lomitapide was high (mean=1200 litres) despite a high degree (>99.8%) of binding to plasma protein.
Slovenian: Po intravenskem dajanju je bil volumen porazdelitve lomitapida velik (povprečno 1200 litrov) kljub veliki stopnji (> 99,8 %) vezave na beljakovine v plazmi.
English: In the Phase 3 study, patients were provided daily dietary supplements of vitamin E, linoleic acid, ALA, EPA and DHA.
Slovenian: V študiji 3. faze so bolniki prejemali dnevne prehranske dodatke vitamina E, linolne kisline, ALA, EPA in DHA.
English: If your tests show some liver problems, your doctor may decide to reduce your dose or stop the treatment.
Slovenian: Če preiskave pokažejo težave z jetri, se bo zdravnik morda odločil, da zmanjša odmerek ali prekine zdravljenje.
English: • Gamma-GT and serum albumin to detect possible liver injury
Slovenian: • vrednost gama-GT in albumina v serumu za ugotavljanje morebitne jetrne poškodbe;
English: Your doctor may increase your dose slowly over time, up to a maximum of 60 mg each day.
Slovenian: Zdravnik lahko postopoma in počasi odmerek povečuje do največ 60 mg na dan.
English: The purpose of the patient alert card is to inform health care professionals of potential drug-drug interactions before any additional medicinal product is prescribed.
Slovenian: Namen opozorilne kartice za bolnika je zdravnike obveščati o morebitnih interakcijah med zdravili, preden predpišejo katero koli dodatno zdravilo.
English: • Lojuxta is only indicated for use in adult patients with HoFH;
Slovenian: • Zdravilo Lojuxta je indicirano samo pri odraslih bolnikih s HoFH;
English: Keep the bottle tightly closed in order to protect from moisture.
Slovenian: Plastenko shranjujte tesno zaprto za zagotovitev zaščite pred vlago.
English: • If, after you have started treatment with Lojuxta, you decide that you would like to become pregnant, please inform your doctor, as your treatment will need to be changed.
Slovenian: • Če se po začetku zdravljenja z zdravilom Lojuxta odločite, da bi radi zanosili, se o tem posvetujte s svojim zdravnikom, saj bo treba spremeniti zdravljenje.
English: Patients should avoid consumption of grapefruit juice (see sections 4.4 and 4.5).
Slovenian: Bolniki se morajo izogibati uživanju soka iz grenivke (glejte poglavji 4.4 in 4.5).
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Because of the potential for adverse effects based on findings in animal studies with lomitapide (see section 5.3), a decision should be made whether to discontinue breast-feeding or discontinue the medicinal product, taking into account the importance of the medicinal product to the mother.
Slovenian: Zaradi potenciala za neželene učinke, ki so jih opazili v študijah z lomitapidom na živalih (glejte poglavje 5.3), se je treba odločiti za prekinitev dojenja ali jemanja zdravila, pri čemer je treba upoštevati koristi zdravila za mater.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete katero koli od naslednjih zdravil:
English: The maximum dose administered to human subjects in clinical studies was 200 mg as a single dose; there were no adverse reactions.
Slovenian: Največji odmerek, ki se je uporabil pri ljudeh v kliničnih študijah, je bil 200 mg v obliki enkratnega odmerka; pri tem ni bilo nobenih neželenih učinkov.
English: • Warning about possible loss of effectiveness of oral contraceptives due to diarrhoea or vomiting and need for additional contraception until 7 days after resolution of symptoms;
Slovenian: • Opozorilo o morebitni izgubi učinkovitosti peroralnih kontracepcijskih sredstev zaradi diareje ali bruhanja in potrebi po dodatni kontracepciji 7 dni po izginotju simptomov;
English: Lomitapide does not inhibit breast cancer resistance protein (BCRP).
Slovenian: Lomitapid ne zavira rezistentnega proteina pri raku dojke (BCRP).
English: Do not use this medicine after the expiry date which is stated on the label or carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki ali škatli poleg oznake „Uporabno do“.
English: • Before initiating treatment in women of child-bearing potential:
Slovenian: • Pred uvedbo zdravljenja pri ženskah v rodni dobi:
English: The patient's “bad” cholesterol level is very high from a very early age.
Slovenian: „slabega“ holesterola so visoke že v zgodnjih letih življenja.
English: ≥3x and <5x Upper Limit of Normal (ULN)
Slovenian: ≥ 3-krat in < 5-krat zgornja meja normalne vrednosti (ULN
English: Mean percent change from baseline through Week 26 using last observation carried forward (LOCF) to each assessment is shown in Figure 1.
Slovenian: Povprečna odstotna sprememba od izhodišča do 26. tedna z uporabo prenosa zadnjega opažanja (LOCF) za vsako oceno je prikazana na sliki 1.
English: • if you have bowel problems or cannot absorb food from your bowel.
Slovenian: • če imate črevesne težave ali ne morete absorbirati hrane iz črevesa;
English: You must also tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to change your dose of Lojuxta:
Slovenian: Prav tako obvestite zdravnika ali farmacevta, če jemljete katero koli od naslednjih zdravil, saj bo zdravnik morda moral spremeniti vaš odmerek zdravila Lojuxta:
English: Lipoprotein (a) (Lp(a)) (nmol/L)
Slovenian: Lipoprotein (a) (Lp(a)) (nmol/l)a
English: The most common adverse reactions were gastrointestinal effects.
Slovenian: Najpogostejši neželeni učinki so bili učinki na prebavila.
English: Changes in lipids and lipoproteins through Week 26 and Week 78 of lomitapide treatment are presented in Table 5.
Slovenian: Spremembe lipidov in lipoproteinov od 26. do 78. tedna pri zdravljenju z lomitapidom so predstavljene vPreglednici 5.
English: • Decrease the dose of Lojuxta by half.
Slovenian: • je treba odmerek zdravila Lojuxta zmanjšati za polovico.
English: The absolute oral bioavailability of lomitapide is 7%.
Slovenian: Absorpcija Absolutna peroralna biološka uporabnost lomitapida je 7 %.
English: • antacids (e.g. ranitidine, cimetidine)
Slovenian: • antacidi (npr. ranitidin, cimetidin),
English: Your doctor will give you a blood test to check your liver before you start taking these capsules, if your dose is increased, and regularly during treatment.
Slovenian: Zdravnik bo krvno preiskavo, s katero bo preveril delovanje jeter, opravil pred začetkom jemanja teh kapsul, ob povečanju odmerka in potem redno med zdravljenjem.
English: The mean dose of lomitapide was 45 mg at Week 26 and 40 mg at Week 78.
Slovenian: Povprečen odmerek lomitapida je bil 45 mg v 26. tednu in 40 mg v 78. tednu.
English: Serious side effects:
Slovenian: Resni neželeni učinki:
English: The effect of Lojuxta on cardiovascular morbidity and mortality has not been determined.
Slovenian: Učinka zdravila Lojuxta na kardiovaskularno obolevnosti in umrljivosti niso ugotovili.
English: • apolipoprotein-B, a protein that carries “bad cholesterol” in the blood
Slovenian: • apolipoproteina B, proteina, ki prenaša „slab holesterol“ po krvi;
English: In an open-label Phase 3 study, 18 of 23 patients with HoFH developed hepatic steatosis (hepatic fat >5.56%) as measured by nuclear magnetic resonance spectroscopy (MRS) (see section 5.1).
Slovenian: V odprti študiji 3. faze se je pri 18 od 23 bolnikov s HoFH razvila jetrna steatoza (maščoba v jetrih > 5,56 %), ki se meri z jedrsko magnetnoresonančno spektroskopijo (MRS) (glejte poglavje 5.1).
English: Safety phase weeks 26-78 N (%)
Slovenian: Faza varnosti Tedni 26-78 N (%)
English: Inter-individual variability in lomitapide AUC was approximately 50%.
Slovenian: Variabilnost vrednosti AUC lomitapida med posamezniki je bila približno 50-odstotna.
English: Prescribers are encouraged to enrol all patients treated with Lojuxta into a global registry.
Slovenian: Zdravnikom priporočamo, da vse bolnike, zdravljene z zdravilom Lojuxta, vključijo v svetovni register.
English: A pharmacokinetic study in patients with ESRD undergoing hemodialysis demonstrated a 36% increase in mean lomitapide plasma concentration compared to matched healthy controls.
Slovenian: Farmakokinetična študija pri bolnikih z ESRD na hemodializi je pokazala 36-odstotno povečanje povprečne koncentracije lomitapida v plazmi v primerjavi z ustrezajočimi zdravimi kontrolami.
English: • Information about taking Lojuxta at bedtime with water at least 2 hours after the evening meal and without food;
Slovenian: • Informacije o jemanju zdravila Lojuxta zvečer z vodo, vsaj 2 uri po večerji, in brez hrane;
English: Monitoring of liver function tests
Slovenian: Spremljanje preiskav jetrnega delovanja
English: Administration with food may increase exposure to lomitapide.
Slovenian: Zaužitje skupaj s hrano lahko poveča izpostavljenost lomitapidu.
English: • Take this medicine once a day at bedtime with a glass of water at least 2 hours after your evening meal (see section 2 under ‘Lojuxta with food, drink and alcohol').
Slovenian: • To zdravilo vzemite enkrat na dan, zvečer s kozarcem vode, vsaj 2 uri po večerji (glejte poglavje 2 „Zdravilo Lojuxta skupaj s hrano, pijačo in alkoholom“).
English: Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.
Slovenian: Izključiti je treba druge oblike primarne hiperlipoproteinemije in sekundarne vzroke hiperholesterolemije (npr. nefrotski sindrom, hipotiroidizem).
English: • if you take more than 40 mg of simvastatin daily (another medicine used to lower cholesterol).
Slovenian: • če jemljete več kot 40 mg simvastatina na dan (drugega zdravila za zniževanje ravni holesterola);
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1;
English: Animal studies have shown developmental toxicity (teratogenicity, embryotoxicity, see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na razvoj ploda (teratogenost, embriotoksičnost, glejte poglavje 5.3).
English: Lomitapide does not induce CYPs 1A2, 3A4, or 2B6, and does not inhibit CYPs 1A2, 2B6, 2C9, 2C19, 2D6, or 2E1.
Slovenian: Lomitapid ne inducira CYP 1A2, 3A4 ali 2B6 in ne zavira CYP 1A2, 2B6, 2C9, 2C19, 2D6 ali 2E1.
English: Adverse clinical consequences of these reductions were not observed with lomitapide treatment of up to 78 weeks.
Slovenian: Pri zdravljenju z lomitapidom neželenih kliničnih posledic tega znižanja niso opazili do 78 tedna.
English: • loss of fluid that may cause headache, dry mouth, dizziness, tiredness or unconsciousness
Slovenian: • izguba tekočine, ki lahko povzroči glavobol, suha usta, omotico, utrujenost ali nezavest
English: Elevations in ALT and/or AST >5 x ULN were managed with a dose reduction or temporary suspension of lomitapide dosing, and all patients were able to continue with study drug treatment.
Slovenian: Povišane ravni ALT in/ali AST, > 5-kratna vrednost ULN, so se obravnavale z zmanjšanjem odmerka ali začasno prekinitvijo odmerjanja lomitapida in vsi bolniki so lahko nadaljevali zdravljenje s študijskim zdravilom.
English: Daily Amount Vitamin E
Slovenian: Vitamin E
English: CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Slovenian: Induktorji CYP3A4 učinkujejo na od časa odvisen način, zato lahko traja 2 tedna, da se po njihovem uvajanju doseže največji učinek.
English: Lomitapide is not expected to directly influence the efficacy of oestrogen based oral contraceptives; however diarrhoea and/or vomiting may reduce hormone absorption.
Slovenian: Ni pričakovati, da bo lomitapid neposredno vplival na učinkovitost estrogenskih peroralnih kontracepcijskih sredstev, vendar lahko diareja in/ali bruhanje zmanjšata absorpcijo hormonov.
English: The safety and efficacy of lomitapide in children <18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Slovenian: Varnost in učinkovitost lomitapida pri otrocih, starih do 18 let, nista bili dokazani, zato uporaba tega zdravila pri otrocih ni priporočljiva.
English: • dehydration, dry mouth
Slovenian: • dehidracija, suha usta,
English: At both Week 26 and Week 78, there were significant reductions in LDL-C, TC, apo B, TG, non-HDL-C, VLDL-C and changes in HDL-C trended lower at Week 26 and returned to baseline levels by Week 78.
Slovenian: V 26. in 78. tednu je prišlo do pomembnega zmanjšanja ravni holesterola LDL, TC, apo B, TG, nonHDL-C, VLDL-C, spremembe HDL-C pa so bile manjše v 26. tednu in so se do 78. tedna vrnile na izhodiščno raven.
English: • To evaluate whether prescribers of lomitapide are following the screening and monitoring recommendations as specified in the product information and the educational materials.
Slovenian: • Oceniti, ali zdravniki, ki predpišejo lomitapid, upoštevajo priporočila glede presejanja in spremljanja, kot je navedeno v podatkih o zdravilu ter izobraževalnem gradivu.
English: This medicine has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: You may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea.
Slovenian: V nekaterih primerih lahko pride do izgube tekočine/dehidracije, npr. v primeru bruhanja, slabosti in driske.
English: After 2 weeks the dose may be increased, based on acceptable safety and tolerability, to 10 mg and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and to the maximum recommended dose of 60 mg (see section 4.8).
Slovenian: Po 2 tednih se lahko odmerek na podlagi sprejemljive varnosti ter tolerance poveča na 10 mg, potem pa v najmanj 4-tedenskih presledkih na 20 mg, 40 mg in največji priporočeni odmerek 60 mg (glejte poglavje 4.8).
English: Cmax and AUC were increased following either a high-fat meal (77% and 58%, respectively) or low fat meal (70% and 28%, respectively).
Slovenian: Vrednosti Cmax in AUC sta se povečali po obroku z veliko vsebnostjo maščob (77 % oziroma 58 %) ali obroku z majhno vsebnostjo maščob (70 % oziroma 28 %).
English: There is no specific treatment in the event of overdose.
Slovenian: Pri prevelikem odmerjanju posebnega zdravljenja ni.
English: Lomitapide pharmacokinetics is approximately dose-proportional for oral single doses in the therapeutic range.
Slovenian: Farmakokinetika lomitapida je približno sorazmerna peroralnim enkratnim odmerkom v terapevtskem razponu.
English: Patients should be advised to immediately contact their physician and stop taking Lojuxta if they become pregnant (see section 4.6).
Slovenian: Bolnicam je treba svetovati, naj se takoj posvetujejo s svojim zdravnikom in prekinejo jemanje zdravila Lojuxta, če zanosijo (glejte poglavje 4.6).
English: Of the parameters examined (race, body mass index (BMI), gender, weight, age), only BMI could be classified as a potential covariate.
Slovenian: Od preučenih parametrov (rasa, indeks telesne mase (ITM), spol, telesna masa, starost) je bilo mogoče samo ITM razvrstiti kot morebitno sospremenljivko.
English: Alternatively, your doctor may decrease your dose of Lojuxta.
Slovenian: Druga možnost je, da zdravnik zmanjša vaš odmerek zdravila Lojuxta.
English: Haemodialysis is unlikely to be beneficial given that lomitapide is highly protein bound.
Slovenian: Hemodializa verjetno pri jemanju lomitapida ne bo koristna glede na to, da se lomitapid dobro veže na beljakovine.
English: Post-marketing reports of dehydration and hospitalisation in patients treated with lomitapide have been reported.
Slovenian: V obdobju trženja zdravila so poročali o dehidraciji in hospitalizaciji bolnikov, zdravljenih z lomitapidom.
English: All patients receiving lomitapide in addition to a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness.
Slovenian: Vsem bolnikom, ki sočasno prejemajo lomitapid ter statin, je treba svetovati glede morebitnega povečanega tveganja za miopatijo in jim naročiti, naj takoj poročajo o kakršni koli nepojasnjeni mišični bolečini, občutljivosti ali šibkosti.
English: • Information on the importance of following a low-fat diet (a diet supplying less than 20% of energy from fat);
Slovenian: • Informacije o pomembnosti upoštevanja diete z majhnim vnosom maščob (diete, pri kateri bolnik dobi manj kot 20 % energije iz maščob);
English: The most serious adverse reactions during treatment were liver aminotransferase abnormalities (see section 4.4).
Slovenian: Najresnejši neželeni učinki med zdravljenjem so bile abnormalnosti jetrnih aminotransferaz (glejte poglavje 4.4).
English: • Advice to exercise caution if Lojuxta is used with other hepatotoxic medicinal products and to consider more frequent monitoring of liver-related tests;
Slovenian: • Nasvet o previdnosti, če se zdravilo Lojuxta uporablja z drugimi hepatotoksičnimi zdravili, in o razmisleku o pogostejšem spremljanju rezultatov jetrnih preiskav;
English: Patients with rare hereditary problems of galactose intolerance, total-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: However, since the medicinal product is dosed in an escalating fashion according to individual patient safety and tolerability, no adjustment to the dosing regimen is recommended based on race.
Slovenian: Ker pa se odmerjanje zdravila veča postopoma ter skladno z varnostjo in toleranco pri posameznem bolniku, se glede na raso ne priporoča nobeno prilagajanje režima odmerjanja.
English: Your doctor may advise you to stop taking Lojuxta or to stop breast-feeding.
Slovenian: Zdravnik vam bo svetoval, da prekinete jemanje zdravila Lojuxta ali prenehate dojiti.
English: Decrease the dose of Lojuxta if elevations of aminotransferase are observed and discontinue treatment for persistent or clinically significant elevations (see Table 1 for specific recommendations).
Slovenian: Odmerek zdravila Lojuxta je treba zmanjšati, če se opazi povišanje ravni aminotransferaze, in zdravljenje prekiniti, če je prisotno persistentno ali klinično pomembno povišanje (glejte preglednico 1 za posebna priporočila).
English: What Lojuxta is and what it is used for What you need to know before you take Lojuxta How to take Lojuxta
Slovenian: Kaj je zdravilo Lojuxta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Lojuxta Kako jemati zdravilo Lojuxta
English: What Lojuxta is and what it is used for
Slovenian: Kaj je zdravilo Lojuxta in za kaj ga uporabljamo
English: In a 1 year repeat-dose study in dogs there were no microscopic changes in the liver although serum AST was minimally increased in females.
Slovenian: V enoletni študiji z večkratnimi odmerki na psih ni bilo nobenih mikroskopskih sprememb v jetrih, čeprav je bila raven AST v serumu pri samicah rahlo povišana.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte z zdravnikom.
English: • Before starting treatment you should confirm you are not pregnant and are using effective contraception, as advised by your doctor.
Slovenian: • Pred začetkom zdravljenja je treba potrditi, da niste noseči in da uporabljate učinkovito kontracepcijo po navodilih zdravnika.