FrancophonIA/ELRC3.0 huggingface dataset:
English: Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Slovenian: Zdravilo Renagel je treba uporabljati v smislu večstranskega pristopa zdravljenja, ki lahko vključuje kalcijeve dodatke, 1,25 - dihidroksi vitamin D3 ali kakšen njegov analog, za nadziranje razvoja renalne osteodistrofije.
English: Acidosis, increased serum chloride levels
Slovenian: Presnovne in prehranske motnje acidoza, zvišana vrednost klorida v serumu
English: If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental vitamins as necessary.
Slovenian: Zato utegne vaš zdravnik nadzirati koncentracijo vitamina D v krvi in vam po potrebi predpisati dodatek vitamina D. Če ne jemljete multivitaminskih dodatkov, vam lahko pade tudi koncentracija vitaminov A, E, K in folne kisline v krvi, zato utegne vaš zdravnik nadzirati tudi te koncentracije in vam po potrebi predpisati dodatne vitamine.
English: He will base the dose on your serum phosphate level.
Slovenian: Zdravnik bo odmerek določil glede na koncentracijo fosfata v serumu.
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Slovenian: Posebno opozorilo bolnikom, ki prejemajo peritonealno dializo Pri vas se lahko razvije peritonitis (okužba vaše trebušne tekočine) zaradi peritoenalne dialize.
English: Renagel 400 mg film-coated tablets
Slovenian: Renagel 400 mg filmsko obložene tablete
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation1, gastrointestinal hemorrhage*1, intestinal ulceration*1, gastrointestinal necrosis*1, colitis*1, intestinal mass*1
Slovenian: Bolezni prebavil navzea, bruhanje driska, dispepsija, flatulenca, bolečine v zgornjem delu trebuha, zaprtje bolečina v trebuhu, obstrukcija črevesa, ileus/subileus, divertikulitis, perforacija črevesa gastrointestinalna krvavitev*1, črevesna razjeda* gastrointestinalna nekroza* kolitis* masa v črevesu*
English: Renagel tablets are film coated, off white, oval tablets with Renagel 400 imprinted on one side.
Slovenian: Zdravilo Renagel tablete so sivo-bele, ovalne, filmsko obložene tablete z natisnjeno oznako Renagel 400 na eni strani.
English: Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side.
Slovenian: Zdravilo Renagel tablete so sivo-bele, ovalne, filmsko obložene tablete z natisnjeno oznako Renagel 800 na eni strani.
English: Renagel 800 mg film-coated tablets
Slovenian: Renagel 800 mg filmsko obložene tablete
English: Renagel is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Slovenian: Zdravilo Renagel se uporablja za uravnavanje koncentracije fosfatov v krvi pri odraslih bolnikih s kronično ledvično odpovedjo, ki se zdravijo s hemodializo oziroma peritonealno dializo.
English: Multipack: 360 (2 bottles of 180) film-coated tablets Multipack: 540 (3 bottles of 180) film-coated tablets.
Slovenian: Skupno pakiranje: 360 (2 plastenki s 180 tabletami) filmsko obloženih tablet Skupno pakiranje: 540 (3 plastenke s 180 tabletami) filmsko obloženih tablet
English: LABEL - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON LABEL with Blue Box - 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
Slovenian: NALEPKA - PLASTENKA S 100 TABLETAMI PO 800 mg NALEPKA - PLASTENKA S 180 TABLETAMI PO 800 mg Z ZUNANJO OVOJNINO NALEPKA s tako imenovanim modrim okencem - 1 PLASTENKA S 180 TABLETAMI PO 800 mg BREZ ZUNANJE OVOJNINE
English: 4 tablets, 3 times per day
Slovenian: 3-krat na dan po 4 tablete
English: In the event of a possible overdose you should contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Renagel, kot bi smeli V primeru prevelikega odmerka se takoj posvetujte z vašim zdravnikom.
English: 1 bottle of 180 film-coated tablets multipacks containing 180 film-coated tablets (6 bottles of 30 tablets) multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)
Slovenian: 1 plastenka s 100 filmsko obloženimi tabletami 1 plastenka s 180 filmsko obloženimi tabletami Pakiranje z več vsebniki, ki vsebuje 180 filmsko obloženih tablet (6 plastenk s 30 tabletami) Pakiranje z več vsebniki, ki vsebuje 360 filmsko obloženih tablet (2 plastenki s 180 tabletami) Pakiranje z več vsebniki, ki vsebuje 540 filmsko obloženih tablet (3 plastenke s 180 tabletami)
English: EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/008 1 bottle of 180 film-coated tablets
Slovenian: EU/1/99/123/011 1 plastenka s 100 filmsko obloženimi tabletami EU/1/99/123/008 1 plastenka s 180 filmsko obloženimi tabletami
English: Talk to your doctor before taking Renagel if any of the following applies to you:
Slovenian: Opozorila in previdnostni ukrepi Če karkoli od naštetega velja za vas, se pred začetkom jemanja zdravila Renagel posvetujte z zdravnikom:
English: 3 tablets, 3 times per day
Slovenian: 3-krat na dan po 3 tablete
English: 2 tablets, 3 times per day
Slovenian: 3-krat na dan po 2 tableti
English: Renagel treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Slovenian: Pri bolnikih, ki imajo hudo zaprtje ali druge hude gastrointestinalne simptome, je treba ponovno pretehtati smiselnost zdravljenja z zdravilom Renagel.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL without Blue Box - BOTTLE OF 360 TABLETS 400 mg (MULTIPACK PRESENTATION)
Slovenian: NALEPKA brez tako imenovanega modrega okenca - PLASTENKA S 360 TABLETAMI PO 400 mg (PAKIRANJE Z VEČ VSEBNIKI)
English: 1 bottle of 180 tablets multipacks containing 180 tablets (6 bottles of 30 tablets) multipacks containing 360 tablets (2 bottles of 180 tablets) multipacks containing 540 tablets (3 bottles of 180 tablets)
Slovenian: Pakiranje z več vsebniki, ki vsebuje 180 tablet (6 plastenki s 30 tabletami) Pakiranje z več vsebniki, ki vsebuje 360 tablet (2 plastenki s 180 tabletami) Pakiranje z več vsebniki, ki vsebuje 540 tablet (3 plastenke s 180 tabletami)
English: Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Slovenian: Glede na vnos hrane in naravo končne odpovedi ledvic se lahko pri dializnih bolnikih pojavijo nizke ravni vitaminov A, D, E in K. Ni mogoče izključiti, da lahko zdravilo Renagel veže v maščobi topne vitamine v zaužiti hrani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 BOTTLE OF 100 TABLETS 800 mg OUTER CARTON - 1 BOTTLE OF 180 TABLETS 800 mg
Slovenian: ZUNANJA OVOJNINA - 1 PLASTENKA S 100 TABLETAMI PO 800 mg ZUNANJA OVOJNINA - 1 PLASTENKA S 180 TABLETAMI PO 800 mg
English: Inflammatory Gastrointestinal Disorders
Slovenian: Zaviralci protonske črpalke
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with Blue Box - MULTIPACK OF 180 (6 BOTTLES OF 30) TABLETS 800 mg
Slovenian: ZUNANJA OVOJNINA s tako imenovanim modrim okencem - SKUPNO PAKIRANJE, KI VSEBUJE 180 (6 PLASTENK S 30 TABLETAMI) TABLET PO 800 mg
English: Renagel may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Slovenian: Zdravilo Renagel se lahko uporablja sočasno s terapijo preprečevanja razvoja bolezni kosti, v sklopu katere se dodaja kalcij in vitamin D.
English: 1 bottle of 360 tablets multipacks containing 720 tablets (2 bottles of 360 tablets) multipacks containing 1080 tablets (3 bottles of 360 tablets)
Slovenian: Pakiranje z več vsebniki, ki vsebuje 720 tablet (2 plastenki s 360 tabletami) Pakiranje z več vsebniki, ki vsebuje 1080 tablet (3 plastenke s 360 tabletami)
English: EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/008 1 bottle of 180 film-coated tablets with outer carton EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton
Slovenian: EU/1/99/123/011 1 plastenka s 100 filmsko obloženimi tabletami EU/1/99/123/008 1 plastenka s 180 filmsko obloženimi tabletami z zunanjo ovojnino EU/1/99/123/012 1 plastenka s 180 filmsko obloženimi tabletami brez zunanje ovojnine
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL without Blue Box - BOTTLE OF 180 TABLETS 800 mg WITH OUTER CARTON (MULTIPACK PRESENTATION)
Slovenian: NALEPKA brez tako imenovanega modrega okenca - PLASTENKA S 180 TABLETAMI PO 800 mg Z ZUNANJO OVOJNINO (SKUPNO PAKIRANJE)
English: EU/1/99/123/005 1 bottle of 360 film-coated tablets EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Slovenian: EU/1/99/123/005 1 plastenka s 360 filmsko obloženimi tabletami EU/1/99/123/006 pakiranje z več vsebniki, ki vsebuje 720 filmsko obloženih tablet (2 plastenki s 360 tabletami)
English: Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “Renagel 400” on one side.
Slovenian: filmsko obložena tableta (tableta) Sivobele ovalne tablete imajo na eni strani natisnjeno oznako „Renagel 400“.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL without Blue Box - BOTTLE OF 30 TABLETS 800 mg (MULTIPACK PRESENTATION)
Slovenian: NALEPKA brez tako imenovanega modrega okenca - PLASTENKA S 30 TABLETAMI PO 800 mg (SKUPNO PAKIRANJE)
English: Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “Renagel 800” on one side.
Slovenian: filmsko obložena tableta (tableta) Sivobele ovalne tablete imajo na eni strani natisnjeno oznako „Renagel 800“.
English: How to store Renagel
Slovenian: Shranjevanje zdravila Renagel
English: The following side effects have been reported in patients taking Renagel: Very common (may affect more than 1 in 10 people): nausea, vomiting.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): siljenje na bruhanje, bruhanje
English: 1 bottle of 360 film-coated tablets multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Slovenian: Pakiranje z več vsebniki, ki vsebuje 720 filmsko obloženih tablet (2 plastenki s 360 tabletami) Pakiranje z več vsebniki, ki vsebuje 1080 filmsko obloženih tablet (3 plastenke s 360 tabletami)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 BOTTLE OF 360 TABLETS 400 mg
Slovenian: ZUNANJA OVOJNINA - 1 PLASTENKA S 360 TABLETAMI PO 400 mg
English: Renagel is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers.
Slovenian: Glede na farmakokinetične raziskave zdravih prostovoljcev z enim samim odmerkom se zdravilo Renagel ne absorbira iz gastrointestinalnega trakta.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 360 TABLETS 400 mg
Slovenian: NALEPKA - PLASTENKA S 360 TABLETAMI PO 400 mg
English: What you need to know before you take Renagel Do not take Renagel:
Slovenian: Kaj je zdravilo Renagel in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Renagel Kako jemati zdravilo Renagel Možni neželeni učinki
English: Renagel 800 mg film-coated tablets sevelamer hydrochloride
Slovenian: Renagel 800 mg filmsko obložene tablete sevelamerijev klorid
English: Renagel 400 mg film-coated tablets sevelamer hydrochloride
Slovenian: Renagel 400 mg filmsko obložene tablete sevelamerijev klorid
English: EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets)
Slovenian: EU/1/99/123/008 1 plastenka s 180 filmsko obloženimi tabletami EU/1/99/123/009 pakiranje z več vsebniki, ki vsebuje 360 filmsko obloženih tablet (2 plastenki s 180 tabletami)
English: Caution should be exercised when Renagel is used in patients with difficulty swallowing.
Slovenian: Zato je treba biti pri teh bolnikih z uporabo zdravila Renagel zelo pazljiv.
English: EU/1/99/123/008 1 bottle of 180 film-coated tablets EU/1/99/123/009 multipacks containing 360 film-coated tablets (2 bottles of 180 tablets) EU/1/99/123/010 multipacks containing 540 film-coated tablets (3 bottles of 180 tablets) EU/1/99/123/011 1 bottle of 100 film-coated tablets EU/1/99/123/012 1 bottle of 180 film-coated tablets without outer carton EU/1/99/123/013 multipacks containing 180 film-coated tablets (6 bottles of 30 tablets)
Slovenian: EU/1/99/123/011 1 plastenka s 100 filmsko obloženimi tabletami EU/1/99/123/012 1 plastenka s 180 filmsko obloženimi tabletami brez zunanje ovojnine EU/1/99/123/013 pakiranje z več vsebniki, ki vsebuje 180 filmsko obloženih tablet (6 plastenk s 30 tabletami)
English: Contents of the pack and other information What Renagel contains
Slovenian: Shranjevanje zdravila Renagel Vsebina pakiranja in dodatne informacije
English: Pruritus, rash
Slovenian: • zapora črevesa
English: EU/1/99/123/006 multipacks containing 720 film-coated tablets (2 bottles of 360 tablets) EU/1/99/123/007 multipacks containing 1080 film-coated tablets (3 bottles of 360 tablets)
Slovenian: EU/1/99/123/006 pakiranje z več vsebniki, ki vsebuje 720 filmsko obloženih tablet (2 plastenki s 360 tabletami)
English: • if you have problems with motility (movement) in your stomach and bowel
Slovenian: • imate težave z nenormalnim ali nepravilnim gibanjem želodca in črevesja
English: OUTER CARTON with the Blue Box - MULTIPACK OF 720 (2 BOTTLES OF 360) TABLETS 400 mg
Slovenian: ZUNANJA OVOJNINA s tako imenovanim modrim okencem - PAKIRANJE Z VEČ VSEBNIKI, KI VSEBUJE 720 (2 PLASTENKI S 360 TABLETAMI) TABLET PO 400 mg ZUNANJA OVOJNINA s tako imenovanim modrim okencem - PAKIRANJE Z VEČ VSEBNIKI, KI VSEBUJE 1080 (3 PLASTENKE S 360 TABLETAMI) TABLET PO 400 mg
English: Multipack: 720 (2 bottles of 360) film-coated tablets.
Slovenian: Pakiranje z več vsebniki: 720 (2 plastenki s 360 tabletami) filmsko obloženih tablet Pakiranje z več vsebniki: 1080 (3 plastenke s 360 tabletami) filmsko obloženih tablet
English: Special note for patients on peritoneal dialysis
Slovenian: Antiaritmiki in antiepileptična zdravila za nadzor epileptičnih napadov
English: Get emergency help right away and call your doctor.
Slovenian: Takoj se obrnite na nujno zdravniško pomoč in pokličite zdravnika.
English: The majority of patients were White (77%) or Asian (21%).
Slovenian: Večina bolnikov je bila bele rase (77 %) ali azijskega porekla (21 %).
English: • Do not take this medicine during pregnancy.
Slovenian: • Tega zdravila ne jemljite med nosečnostjo.
English: Elderly, gender, and race
Slovenian: Starejši, spol in rasa
English: • Ringing/sound in the ears (tinnitus)
Slovenian: • zvenenje v ušesih (tinitus)
English: • Dehydration (loss of body fluids)
Slovenian: • dehidracija (izguba telesnih tekočin)
English: Frequency categories are 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), and not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so opredeljene na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Elderly (≥ 65 years) and race
Slovenian: Starejši (≥ 65 let) in vpliv rase
English: The tablets should be taken orally twice daily approximately 12 hours apart with or without food (see section 5.2).
Slovenian: Tablete je treba jemati peroralno, dvakrat na dan, v približno 12-urnih časovnih presledkih, skupaj s hrano ali brez nje (glejte poglavje 5.2).
English: • Lack of energy, feeling weak or tired
Slovenian: • pomanjkanje energije, občutek šibkosti ali utrujenosti
English: The current safety database for axitinib is too small to detect rare and very rare adverse reactions.
Slovenian: Trenutna zbirka podatkov o varnosti za aksitinib je premajhna, da bi zaznala redke in zelo redke neželene učinke.
English: Effect on QTc interval
Slovenian: Vpliv na interval QTc
English: Inlyta with food and drink
Slovenian: Zdravilo Inlyta skupaj s hrano in pijačo
English: Do not use any pack that is damaged or shows signs of tampering.
Slovenian: Ne uporabite pakiranja, ki je poškodovano ali kaže znake, da je že bilo odprto.
English: Risk ratio is used for ORR.
Slovenian: Za ORR so uporabili razmerje tveganja.
English: If you have high blood pressure (hypertension) you may be treated with medicines to reduce the blood pressure.
Slovenian: Če imate visok krvni tlak (hipertenzijo), morda dobivate zdravila za zniževanje krvnega tlaka.
English: Two of the subgroups were too small to give reliable results (prior temsirolimus treatment or prior bevacizumab treatment).
Slovenian: Dve od podskupin sta bili premajhni, da bi bilo mogoče dobiti zanesljive rezultate (predhodno zdravljenje s temsirolimusom oziroma predhodno zdravljenje z bevacizumabom).
English: Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product.
Slovenian: Aksitiniba se ne sme uporabljati med nosečnostjo, razen če klinično stanje ženske zahteva zdravljenje s tem zdravilom.
English: Based on the review of the data submitted in the PSUR procedure, including case reports and one literature article, and considering that a plausible biological mechanism exists, there is at least a reasonable possibility that axitinib may cause cholecystitis.
Slovenian: Na podlagi pregleda podatkov, oddanih v postopku ocene poročila PSUR, vključno s poročili o primerih in enim literaturnim člankom, in upoštevajoč, da obstaja verjeten biološki mehanizem, obstaja razumna možnost, da lahko aksitinib povzroča holecistitis.
English: The next prescribed dose should be taken at the usual time.
Slovenian: Naslednji predpisan odmerek je treba vzeti ob običajnem času.
English: Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs that cannot be managed by concomitant medicinal products or dose adjustments.
Slovenian: Zdravljenje naj traja tako dolgo, dokler je mogoče opaziti klinično korist oziroma do pojava nesprejemljive toksičnosti, ki je ni mogoče obvladovati s sočasno uporabljanimi zdravili ali prilagajanjem odmerka.
English: An increase in red blood cell mass may increase the risk of embolic and thrombotic events.
Slovenian: Zvečanje mase rdečih krvničk lahko zveča tveganje za pojav emboličnih in trombotičnih dogodkov.
English: Date of latest renewal: 22 May 2017
Slovenian: Datum prve odobritve: 3. september 2012 Datum zadnjega podaljšanja: 22. maj 2017
English: • If you have high blood pressure.
Slovenian: • Če imate visok krvni tlak.
English: You must immediately contact your doctor if you experience any of those following serious side effects (see also section 2 “What you need to know before you take Inlyta”):
Slovenian: Nemudoma se posvetujte z zdravnikom, če se pri vas pojavi katerikoli izmed naslednjih resnih neželenih učinkov (glejte tudi poglavje 2, ''Kaj morate vedeti, preden boste vzeli zdravilo Inlyta''):
English: They should be swallowed whole with a glass of water.
Slovenian: Tablete je treba pogoltniti cele, s kozarcem vode.
English: • dexamethasone, a steroid medicine prescribed for many different conditions, including serious illnesses;
Slovenian: • deksametazon, steroidno zdravilo, ki se predpisuje za mnoga različna stanja, vključno s hudimi boleznimi;
English: Do not take this medicine with grapefruit or grapefruit juice, as it may increase the chance of side effects.
Slovenian: Tega zdravila ne jemljite skupaj z grenivkami ali grenivkinim sokom, ker to lahko zveča možnost za pojav neželenih učinkov.
English: Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking this medicine.
Slovenian: Obvestite zdravnika, če se hitreje utrudite, vas običajno bolj zebe kot druge ljudi, ali če se vaš glas med jemanjem tega zdravila poglobi.
English: The medicines listed in this leaflet may not be the only ones that could interact with Inlyta.
Slovenian: Zdravila, navedena v tem navodilu, morda niso edina, ki bi lahko medsebojno delovala z zdravilom Inlyta.
English: • Inlyta could harm an unborn baby or breast-fed baby.
Slovenian: • Zdravilo Inlyta lahko škoduje nerojenemu otroku ali dojenemu otroku.
English: • Severe increase in blood pressure (hypertensive crisis).
Slovenian: • Izrazito zvišanje krvnega tlaka (hipertenzivna kriza).
English: • nefazodone, used to treat depression.
Slovenian: • nefazodon, ki se uporablja za zdravljenje depresije.
English: • Use a reliable method of contraception while you are taking Inlyta and up to 1 week after the last dose of this medicine, to prevent pregnancy.
Slovenian: • Med jemanjem zdravila Inlyta in še en teden po zadnjem odmerku tega zdravila uporabljajte zanesljivo metodo kontracepcije, da preprečite nosečnost.
English: Women of childbearing potential must use effective contraception during and up to 1 week after treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še en teden po njem.
English: The safety and efficacy of axitinib were evaluated in a randomised, open-label, multicenter Phase 3 study.
Slovenian: Varnost in učinkovitost aksitiniba so ocenjevali v randomiziranem, odprtem, multicentričnem preskušanju 3. faze.
English: What Inlyta is and what it is used for
Slovenian: Kaj je zdravilo Inlyta in za kaj ga uporabljamo
English: If you are not able to take this medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor right away.
Slovenian: Če tega zdravila ne morete jemati tako, kot vam je predpisal zdravnik, ali imate občutek, da ga ne potrebujete več, se nemudoma posvetujte z zdravnikom.
English: Swallow the tablets whole with water, with or without food.
Slovenian: Tablete pogoltnite cele, z nekaj vode, skupaj s hrano ali brez nje.
English: In the case of persistent hypertension, despite use of antihypertensive medicinal products, the axitinib dose should be reduced.
Slovenian: V primeru trdovratne hipertenzije, kljub uporabi antihipertenzivnih zdravil, je treba odmerek aksitiniba zmanjšati.
English: Take the Inlyta doses approximately 12 hours apart.
Slovenian: Odmerke zdravila Inlyta jemljite v približno 12-urnih presledkih.
English: If you are allergic to axitinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na aksitinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: The safety of reinitiating axitinib therapy in patients previously experiencing PRES is not known.
Slovenian: Varnost ponovne uvedbe zdravljenja z aksitinibom pri bolnikih, pri katerih je v preteklosti prišlo do PRES, ni znana.
English: Treatment with axitinib should be stopped at least 24 hours prior to scheduled surgery.
Slovenian: Zdravljenje z aksitinibom je treba prekiniti najmanj 24 ur pred načrtovanim kirurškim posegom.
English: The geometric mean oral clearance and apparent volume of distribution were 38 L/h and 160 L, respectively.
Slovenian: Geometrična srednja vrednost očistka po peroralni uporabi in navidezni volumen porazdelitve sta znašala 38 l/h oziroma 160 l.
English: Your doctor may change the dose of these medicines, change the dose of Inlyta, or switch you to a different medicine.
Slovenian: Zdravnik bo morda spremenil odmerek teh zdravil, spremenil odmerek zdravila Inlyta ali vam predpisal kakšno drugo zdravilo.