FrancophonIA/ELRC3.0 huggingface dataset:
English: Capsule shell: gelatin sorbitol special-glycerin blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water) titanium dioxide (E171) printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)
Slovenian: Ovojnica kapsule: želatina zmes sorbitola in posebenega glicerola (glicerol, sorbitol, sorbitol anhidridi (1,4-sorbitan), manitol in voda) titanov dioksid (E171) tiskarsko črnilo (alkohol SDA 35A (etanol & etilacetat), propilenglikol (E1520), črni železov oksid (E172), polivinilacetat ftalat, prečiščena voda, izopropilalkohol, makrogol 400, amonijev hidroksid 28 %)
English: No formal studies to evaluate interactions with bexarotene have been conducted.
Slovenian: Dosedaj ni bilo opravljenih študij za ovrednotenje medsebojnega delovanja beksarotena z drugimi zdravili.
English: Number of 75 mg Targretin capsules
Slovenian: Število 75 mg Targretin kapsul
English: What Targretin contains
Slovenian: Kaj vsebuje zdravilo Targretin
English: Off-white capsule, containing a liquid suspension and imprinted with “Targretin”.
Slovenian: Kapsule bele kremne barve z natisnjenim napisom “Targretin”, ki vsebujejo tekočo suspenzijo.
English: One capsule contains 75 mg of bexarotene.
Slovenian: Ena kapsula vsebuje 75 mg beksarotena.
English: Fasting triglycerides should be normal or normalised with appropriate intervention prior to bexarotene therapy.
Slovenian: Trigliceridi (na tešče) morajo pred začetkom terapije z beksarotenom biti na normalni ravni oz. se morajo normalizirati.
English: The capsule shell consists of gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171) and printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%).
Slovenian: Ovojnica kapsule je iz želatine, zmesi sorbitola in posebnega glicerola (glicerol, sorbitol, sorbitol anhidridi (1,4-sorbitan), manitol in voda), titanovega dioksida (E171) in črnila (alkohol SDA 35A (etanol & etilacetat), propilenglikol (E1520), črni železov oksid (E172), polivinilacetat ftalat, prečiščena voda, izopropilalkohol, makrogol 400, amonijev hidroksid 28 %).
English: Acute pancreatitis associated with elevations of fasting serum triglycerides has been reported in clinical studies.
Slovenian: V poročilih kliničnih študij so akutni pankreatitis povezali z zvišanimi serumskimi trigliceridi (na tešče).
English: The active substance in Targretin, bexarotene, belongs to a group of medicines known as retinoids, which are related to vitamin A.
Slovenian: Spada v skupino zdravil, ki je znana kot retoinoidi in je sorodna vitaminu A.
English: How to take Targretin
Slovenian: Kako jemati zdravilo Targretin
English: Baseline thyroid function tests should be obtained and then monitored at least monthly during treatment and as indicated by the emergence of symptoms consistent with hypothyroidism.
Slovenian: Potrebno je izvesti temeljno testiranje delovanja ščitnice ter določitev osnovnih vrednosti, ki pa jih je treba spremljati najmanj enkrat na mesec v času zdravljenja, če se pojavijo simptomi, ki kažejo na hipotiroidizem.
English: Body Weight and Gender: Based on the population pharmacokinetics analysis of data for 614 patients with a weight range of 26 to 145 kg, the bexarotene apparent clearance increases with increasing body weight.
Slovenian: 614 bolnikov z telesno maso v mejah 26 do 145 kg se navidezni očistek beksarotena zvečuje z naraščajočo telesno maso.
English: • gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol),
Slovenian: • gemfibrozil (za znižanje visokih koncentracij maščob v krvi, kot so trigliceridi in holesterol), vitaminski dodatki vitamina A, inhibitorji proteaze (za zdravljenje virusnih infekcij),
English: Butylated hydroxyanisole may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Slovenian: Butilhidroksianizol lahko draži sluznice, zato morate kapsule pogoltniti cele in jih ne smete žvečiti.
English: Ecchymosis, petechia, abnormal white blood cells, thromboplastin decreased, abnormal erythrocytes, dehydration, increased gonadotrophic luteinizing hormone, weight loss, increased alkaline phosphatase, increased creatinine phosphokinase, lipase increased, hypercalcaemia, migraine, peripheral neuritis, paraesthesia, hypertonia, confusion, anxiety, emotional lability, somnolence, decreased libido, nervousness, night blindness, nystagmus, lacrimation disorder, tinnitus, taste perversion, chest pain, arrhythmia, peripheral vascular disorder, generalized oedema, haemoptysis, dyspnoea, increased cough, sinusitis, pharyngitis, dysphagia, mouth ulceration, oral moniliasis, stomatitis, dyspepsia, thirst, abnormal stools, eructation, vesicobullous rash, maculopapular rash, leg cramps, haematuria, flu syndrome, pelvic pain, and body odour.
Slovenian: Ekhimoza, petehije, nenormalni levkociti, znižan tromboplastin, nenormalni eritrociti, dehidracija, zvišan gonadotropni luteinizirajoči hormon, izguba teže, zvišana alkalna fosfataza, zvišana kreatinin-fosfokinaza, zvišana lipaza, hiperkalcemija, migrena, periferni nevritis, parestezija, hipertonija, zmedenost, strah, emocionalna labilnost, zaspanost, zmanjšan libido, nervoznost, nočna slepota, nistagmus, motnje solzenja, tinitus, motnje okušanja, bolečine v prsih, aritmija, periferne žilne bolezni, generaliziran edem, hemoptiza, dispneja, povečan kašelj, sinusitis, faringitis, disfagija, razjede v ustih, oralna moniliaza, stomatitis, dispepsija, žeja, nenormalno blato, kolcanje, vezikularni izpuščaji, makulopapulozni izpuščaji, krči v nogah, hematurija, sindrom influence, medenične bolečine in telesni vonj.
English: Determination of haemoglobin should be obtained at baseline, weekly during the first month and then monthly thereafter.
Slovenian: Določitev hemoglobina je treba izvesti pred začetkom zdravljenja (Baseline), nato pa tedensko v prvem mesecu in pozneje enkrat na mesec.
English: Single observations of the following were also reported: bone marrow depression, decreased prothrombin, decreased gonadotrophic luteinizing hormone, increased amylase, hyponatraemia, hypokalaemia, hyperuricaemia, hypocholesterolaemia, hypolipaemia, hypomagnesaemia, abnormal gait, stupor, circumoral paraesthesia, abnormal thinking, eye pain, hypovolaemia, subdural haematoma, congestive heart failure, palpitation, epistaxis, vascular anomaly, vascular disorder, pallor, pneumonia, respiratory disorder, lung disorder, pleural disorder, cholecystitis, liver damage, jaundice, cholestatic jaundice, melaena, vomiting, laryngismus, tenesmus, rhinitis, increased appetite, gingivitis, herpes zoster, psoriasis, furunculosis, contact dermatitis, seborrhoea, lichenoid dermatitis, arthritis, joint disorder, urinary retention, impaired urination, polyuria, nocturia, impotence, urine abnormality, breast enlargement, carcinoma, photosensitivity reaction, face oedema, malaise, viral infection, enlarged abdomen.
Slovenian: Obstajajo posamezna poročila o naslednjih neželenih učinkih: depresija kostnega mozga, znižan protrombin, znižan gonadotropni luteinizirajoči hormon, zvišana amilaza, hiponatremija, hipokaliemija, hiperurikemija, hiperholesterolemija, hiperlipemija, hipomagneziemija, nenormalna hoja, stupor, cirkumoralna parestezija, nenormalno mišljenje, bolečine v očeh, hipovolemija, subduralni hematom, srčno popuščanje, palpitacije, epistaksa, vaskularne anomalije, žilne bolezni, bledica, pljučnica, bolezni dihalnih poti, bolezni pljuč, plevralne motnje, holecistitis, okvara jeter, zlatenica, obstruktivna zlatenica, melena, bruhanje, laringospazem, tenezmi, rinitis, povečan apetit, gingivitis, pasavec, psoriaza, furunkuloza, kontaktni dermatitis, seboreja, lihenoidni dermatitis, artritis, bolezni sklepov, zastoj seča, moteno uriniranje, poliurija, nikturíja, impotenca, nenormalnosti seča, povečanje obsega prsi, karcinom, preobčutljivost za svetlobo, edem obraza, občutek slabosti, virusna okužba in povečan trebuh.
English: No cases of hypoglycaemia associated with the use of bexarotene as monotherapy have been reported.
Slovenian: Dosedaj niso poročali o primerih hipoglikemije pri uporabi beksarotena kot monoterapije.
English: Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids.
Slovenian: Pri bolnikih z znano preobčutljivostjo za retinoide je treba Targretin kapsule uporabljati previdno.
English: Each capsule contains 75 mg of bexarotene.
Slovenian: Vsaka kapsula vsebuje 75 mg beksarotena.
English: Generally, these resolved without sequelae on dose reduction or withdrawal of treatment.
Slovenian: Ti neželeni učinki so praviloma izginili brez posledic po zmanjšanju odmerka ali prekinitvi zdravljenja.
English: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including bexarotene.
Slovenian: Pri bolnikih, zdravljenih s sistemskimi retinoidi, vključno z beksarotenom, so poročali o depresiji, poslabšanju depresije, anksioznosti in spremembah razpoloženja.
English: Albuminuria Kidney Function Abnormal
Slovenian: Bolezni sečil albuminurija nenormalno delovanje ledvic
English: Determination of white blood cell count with differential count should be obtained at baseline, weekly during the first month and then monthly thereafter.
Slovenian: Določitev števila levkocitov skupaj z diferencialno krvno sliko je treba izvesti pred začetkom zdravljenja (Baseline), nato pa tedensko v prvem mesecu in pozneje enkrat na mesec.
English: Every attempt should be made to maintain triglyceride levels below 4.52 mmol/l in order to reduce the risk of clinical sequelae.
Slovenian: V izogib posledični klinični bolezni mora biti posebna pozornost posvečena temu, da se vrednost trigliceridov nahaja pod nivojem 4,52 mmol/l.
English: Vomiting Diarrhoea Nausea Anorexia Liver Function Tests Abnormal Cheilitis Dry Mouth Constipation Flatulence
Slovenian: Bolezni prebavil bruhanje driska slabost anoreksija nenormalni izvidi pri testiranju jetrne funkcije vnetje ustnice suha usta zaprtje vetrovi pankreatitis odpoved jeter bolezni prebavil
English: No clinical experience with an overdose of Targretin has been reported.
Slovenian: O primerih prevelikega odmerjanja Targretina ni kliničnih izkušenj.
English: The following side effects were reported in patients with CTCL who were treated with the recommended initial dose of capsules.
Slovenian: Pri CTCL bolnikih, ki so se zdravili s priporočenim začetnim odmerkom kapsul, so opazili sledeče neželene učinke.
English: Of these, liver failure, subsequently determined to be not related to bexarotene, was the only one to occur in a CTCL patient.
Slovenian: Od naštetih je bila odpoved jeter edini učinek, ki se je pojavil pri CTCL bolniku.
English: Bexarotene should not be used in breast-feeding mothers.
Slovenian: Doječe matere ne smejo jemati beksarotena.
English: However, an adverse effect of long-term bexarotene treatment on lens opacity formation in humans has not been excluded.
Slovenian: Vendar pa niso izključili neželenih učinkov pri dolgoročnem zdravljenju z beksarotenom glede na motnost očesne leče pri ljudeh.
English: History of pancreatitis.
Slovenian: Anamneza pankreatitisa.
English: Newly observed adverse reactions
Slovenian: Novo opaženi neželeni učinki so bili
English: Psychiatric disorders
Slovenian: Psihiatrične motnje:
English: Blood tests to evaluate the function of your liver and thyroid gland and to monitor your red blood cell and white blood cell counts will be obtained before therapy is started and will be monitored during therapy.
Slovenian: Pred začetkom terapije je treba izvesti analizo krvi za oceno delovanja vaših jeter in ščitnice ter za spremljanje števila eritrocitov in levkocitov.
English: Consideration should be given to a suspension or discontinuation of bexarotene if test results reach greater than three times the upper limit of normal values for SGOT/AST, SGPT/ALT, or bilirubin.
Slovenian: V primeru, da rezultati testiranja dosežejo trikratno vrednost ali celo višjo v primerjavi z zgornjo mejo normalne vrednosti za SGOT/AST, SGPT/ALT ali bilirubin, je treba razmišljati o začasni ali celotni prekinitvi jemanja beksarotena.
English: Under similar conditions, bexarotene concentrations were not affected by concomitant administration of atorvastatin or levothyroxine.
Slovenian: Pod podobnimi pogoji sočasno dajanje atorvastatina ali levotiroksina ni vplivalo na koncentracijo beksarotena v plazmi.
English: However, concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene and therefore, concomitant administration of gemfibrozil with bexarotene is not recommended (see section 4.5).
Slovenian: Iz tega razloga sočasno dajanje gemfibrozila skupaj z beksarotenom ni priporočljivo (glejte poglavje 4.5).
English: Cataract Specified Amblyopia Visual Field Defect Corneal Lesion Abnormal Vision Blepharitis Conjunctivitis
Slovenian: Očesne bolezni suhe oči očesne bolezni določena katarakta ambliopija izpad vidnega polja lezije roženice nenormalni vid blefaritis konjunktivitis
English: Caution is advised in case of combination with CYP3A4 substrates having a narrow therapeutic margin i.e. immunosuppressive agents (cyclosporine, tacrolimus, sirolimus) as well as CYP3A4-metabolised cytotoxics, i.e. cyclophosphamide, etoposide, finasteride, ifosfamide, tamoxifen, vinca-alcaloids.
Slovenian: pri imunosupresivnih sredstvih (ciklosporin, takrolimus, sirolimus), pa tudi pri citotoksičnih sredstvih, ki jih presnavlja CYP3A4, kot so ciklofosfamid, etopozid, finasterid, ifosfamid, tamoksifen, alkaloidi vinca.
English: Neoplasm Fever Cellulitis Infection Parasitic Mucous Membrane Disorder Back Pain Lab Test Abnormal adverse reactions noted with increased frequency when bexarotene was administered at a dose >300mg/m2/day.
Slovenian: Splošne težave in spremembe na mestu aplikacije bolečina glavobol astenija alergijska reakcija infekcija mrzlica trebušne bolečine spremenjen nivo hormonov neoplazma zvišana telesna temperatura celulitis parazitska infekcija bolezni sluznic bolečine v hrbtu nenormalni rezultati laboratorijskih preiskav neželeni učinki so bili opaženi z višjo pogostnostjo, če je bil beksaroten uporabljen v odmerku
English: LFT elevations associated with the use of bexarotene have been reported.
Slovenian: Poročali so o povečanih vrednostih pri testiranju jetrne funkcije (LFT), ki so povezane z uporabo beksarotena.
English: Caution should be exercised when administering bexarotene in patients using insulin, agents enhancing insulin secretion (e.g. sulfonylureas), or insulin-sensitisers (e.g. thiazolidinediones).
Slovenian: Bolniki s sladkorno boleznijo (diabetes mellitus) Pri dajanju beksarotena bolnikom, ki uporabljajo inzulin, sredstva za izboljšanje izločanja inzulina (npr. sulfonil sečnine), ali inzulinske senzibilizatorje (npr. tiazolidinedion), je potrebna posebna previdnost.
English: Skin Ulcer Alopecia Skin Hypertrophy Skin Nodule Acne Sweating Dry Skin Skin Disorder
Slovenian: Bolezni kože in podkožja eksfoliativni dermatitis pruritus izpuščaji ulkus kože alopecija kožna hipertrofija kožni vozli akne znojenje suha koža bolezni kože močna izsušenost herpes simpleks pustularni izpuščaji sprememba barve kože težave z lasmi težave z nohti
English: Weight Gain SGOT Increased SGPT Increased Lactic Dehydrogenase Increased Creatinine Increased Hypoproteinaemia
Slovenian: Presnovne in prehranske motnje hiperlipemija hiperholesterolemija povečanje telesne mase zvišan SGOT zvišan SGPT zvišana laktat-dehidrogenaza zvišan kreatinin hipoproteinemija protin bilirubinemija zvišana stopnja dušika v krvi znižan HDL
English: Each Targretin capsule contains 75 mg of the active substance bexarotene.
Slovenian: Vsaka kapsula zdravila Targretin vsebuje 75 mg zdravilne učinkovine beksaroten.
English: Targretin 75 mg soft capsules
Slovenian: Targretin 75 mg mehke kapsule
English: Irreversible cataracts involving the posterior area of the lens occurred in rats and dogs treated with bexarotene at systemic exposures that are achievable clinically in humans.
Slovenian: Pri psih in podganah, katere so preučevali pri sistemskih izpostavljenostih, ki se lahko klinično dosežejo tudi pri ljudeh, so se pojavile trajne katarakte, ki so zajemali tudi zadnji (posteriorni) del leče.
English: • dexamethasone (used for inflammatory conditions),
Slovenian: • deksametazon (za zdravljenje vnetij),
English: Thyroid function test alterations
Slovenian: Spremembe pri testiranju delovanja ščitnice
English: High-density polyethylene bottles with child-resistant closures containing 100 capsules.
Slovenian: Plastenke iz polietilena visoke gostote s pokrovom, varnim za otroke.
English: Tell your doctor as soon as possible if you feel any deterioration in your condition while you are taking Targretin.
Slovenian: Če med jemanjem zdravila Targretin opazite poslabšanje svojega zdravstvenega stanja, o tem čimprej obvestite zdravnika.
English: - if you have a history of pancreatitis, have uncontrolled lipid (blood fats) elevations (high blood cholesterol or high blood triglycerides), have a condition known as hypervitaminosis A, have uncontrolled thyroid disease, have insufficient liver function or have an ongoing systemic infection.
Slovenian: - če ste alergični na beksaroten ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste noseči, če dojite ali če lahko zanosite in ne uporabljate učinkovitega kontracepcijskega sredstva; - če imate anamnezo pankreatitisa, imate nekontrolirane povišane lipide (krvne maščobe), (visoke krvne vrednosti holesterola ali visoke krvne vrednosti trigliceridov), če imate hipervitaminozo A, če imate nekontrolirane bolezni ščitnice, če imate jetrno insuficienco ali prebolevate okužbo.
English: Targretin 75 mg soft capsules Bexarotene
Slovenian: TARGRETIN 75 mg mehke kapsule beksaroten
English: TARGRETIN 75 mg soft capsules Bexarotene
Slovenian: Targretin 75 mg mehke kapsule beksaroten
English: Furthermore, co-administration with CYP3A4 inducers such as rifampicin, phenytoin, dexamethasone or phenobarbital may theoretically cause a reduction in plasma bexarotene concentrations.
Slovenian: Nadalje lahko sočasna uporaba induktorjev CYP3A4, kot so rifampicin, fenitoin,
English: Lens opacities
Slovenian: Motnost očesne leče
English: Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, elevated and decreased numbers of blood platelets.
Slovenian: Bolezni krvi in limfatičnega sistema levkopenija reakcija podobna limfomu limfadenopatija hipokromna anemija krvna diskrazija purpura koagulacijske motnje podaljšan čas koagulacije anemija
English: You must use effective contraception (birth control) continuously starting one month before beginning therapy until one month after you stop taking Targretin.
Slovenian: Najmanj en mesec pred začetkom terapije morate nepretrgoma uporabljati učinkovito kontracepcijsko sredstvo.
English: Blood Dyscrasia Purpura Coagulation Disorder Coagulation Time Increased Anaemia Thrombocytopenia Thrombocythemia Eosinophilia Leukocytosis Lymphocytosis
Slovenian: Občasni trombocitopenija trombocithemija eozinofilija levkocitoza limfocitoza
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v kosteh artralgija mialgija miastenija
English: Endocrine disorders
Slovenian: Bolezni živčevja
English: adverse reactions noted with increased frequency when bexarotene was administered at a dose of >300 mg/m2/day (compared to administration to CTCL patients at 300 mg/m2/day) in non-CTCL cancer patients.
Slovenian: > 300 mg/m2/dan pri bolnikih brez CTCL (v primerjavi z uporabo pri bolnikih s CTCL v odmerku
English: Leucopenia associated with bexarotene therapy has been reported in clinical studies.
Slovenian: V kliničnih študijah so poročali o povezanosti levkopenije z beksarotensko terapijo.
English: Anaemia associated with bexarotene therapy has been reported in clinical studies.
Slovenian: V kliničnih študijah so poročali o povezanosti anemije z beksaroten terapijo.
English: Elevation of blood fats (triglycerides and cholesterol).
Slovenian: Test krvnih lipidov na tešče (trigliceridi in holesterol) je treba izvršiti pred začetkom terapije z beksarotenom.
English: Leucopenia
Slovenian: Levkopenija
English: Women of childbearing potential must use adequate birth-control measures when bexarotene is used.
Slovenian: V času jemanja beksarotena si morajo ženske v rodni dobi zagotoviti učinkovito kontracepcijo.
English: 200 (2 x 100) tablets (multipack)
Slovenian: 200 (2 x 100) tablet (skupno pakiranje)
English: Elimination half-life is 8-12 hours.
Slovenian: Razpolovna doba izločanja je 8-12 ur.
English: Less than 1% of the dose is excreted unchanged in urine.
Slovenian: Manj kot 1 % odmerka se nespremenjenega izloči v urin.
English: It may harm them, even if their symptoms are the same as yours.
Slovenian: Njim bi lahko celo - škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: This medicine has been authorised under “exceptional circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Slovenian: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje
English: You must not take Onsenal if you are pregnant or if it is possible that you become pregnant.
Slovenian: Zdravila Onsenal ne smete uporabljati, če ste noseči ali bi lahko zanosili.
English: Severe renal impairment is a contraindication to use.
Slovenian: Huda ledvična okvara je kontraindikacija za uporabo zdravila.
English: The study population included 58 patients with a prior subtotal or total colectomy and 25 patients with an intact colon.
Slovenian: Populacija zajeta v študije je vključevala 58 bolnikov po nepopolni ali popolni kolektomiji in 25 bolnikov z intaktnim kolonom.
English: • Known hypersensitivity to sulphonamides.
Slovenian: • Znana preobčutljivost za sulfonamide.
English: • Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Germany
Slovenian: • Pfizer Manufacturing Deutschland GmbH, Heinrich-Mack-Strasse 35, 89257 Illertissen, Nemčija
English: Frequency Not Known (Post-marketing experience)1
Slovenian: Pogostnost ni znana (pomarketinške izkušnje)
English: It may also play a role in ulcer healing.
Slovenian: Morda ima tudi določeno vlogo pri celjenju ulkusov.
English: No studies on the effect on the ability to drive and use machines have been performed.
Slovenian: Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: Do not take a double dose to make up for forgotten individual doses.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: If you feel dizzy or tired after taking Onsenal, do not drive or use machinery until you are feeling normal again.
Slovenian: Če po uporabi zdravila Onsenal čutite omotico ali utrujenost, ne vozite in ne upravljajte strojev, dokler se spet ne počutite normalno.
English: Elderly: The dose for elderly FAP patients has not been established.
Slovenian: Starejši: Odmerek za starejše bolnike s FAP ni ugotovljen.
English: Taking ONSENAL with food and drink You can take Onsenal with or without food.
Slovenian: Jemanje zdravila Onsenal s hrano in pijačo Zdravilo Onsenal lahko vzamete s hrano ali brez nje.