FrancophonIA/ELRC3.0 huggingface dataset:
English: Revatio must not be taken with nitrates (medicines used to treat angina), or with medicines that could affect the way that Revatio is broken down in the body, such as ketoconazole or itraconazole (antifungal medicines) and ritonavir (used to treat HIV infection).
Slovenian: Zdravilo Revatio se ne sme jemati skupaj z nitrati (zdravili za zdravljenje angine pektoris) ali zdravili, ki lahko vplivajo na razgradnjo zdravila Revatio v telesu, kot sta ketokonazol ali itrakonazol (zdravili za glivične okužbe), in ritonavirjem (ki se uporablja za zdravljenje okužbe z virusom HIV).
English: In adults, Revatio is taken at a dose of 20 mg three times a day.
Slovenian: Pri odraslih se zdravilo Revatio jemlje v odmerku 20 mg trikrat na dan.
English: Revatio is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Slovenian: Zdravilo Revatio se uporablja za zdravljenje odraslih in otrok, starejših od enega leta, s pljučno arterijsko hipertenzijo (PAH, nenormalno visokim krvnim tlakom v pljučnih arterijah).
English: In adults, Revatio is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Slovenian: Pri odraslih se zdravilo uporablja pri bolnikih s pljučno arterijsko hipertenzijo razreda II (rahla omejitev fizične dejavnosti) ali III (znatna omejitev fizične dejavnosti).
English: How does Revatio work?
Slovenian: Kako zdravilo Revatio deluje?
English: When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Slovenian: Če je snov, imenovana „ciklični gvanozinmonofosfat“ (cGMP), zavirana, se ne more razgraditi in ostane v žilah, kjer povzroči, da se te sprostijo in razširijo.
English: Revatio is available as tablets (20 mg), a solution for injection (0.8 mg/ml) and a powder to be made up into an oral suspension (10 mg/ml).
Slovenian: Zdravilo Revatio je na voljo v obliki tablet (20 mg), raztopine za injiciranje (0,8 mg/ml) in praška za pripravo peroralne suspenzije (10 mg/ml).
English: For practical information about using Revatio, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Revatio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: After 16 weeks, the maximum volume of oxygen the children used during exercise increased on average by 10.2% with Revatio compared with 0.5% with placebo.
Slovenian: Po 16 tednih se je največji volumen kisika, porabljen med vajo, povečal povprečno za 10,2 % pri otrocih, ki so jemali zdravilo Revatio, v primerjavi s tistimi, ki so jemali placebo.
English: Change in exercise capacity in this study was measured as the improvement in the maximum volume of oxygen used during exercise after 16 weeks of treatment, in children able to perform the exercise tests.
Slovenian: Spremembe v telesni zmogljivosti v tej študiji so med otroki, ki so lahko opravili test, merili z izboljšanjem največjega volumna kisika, ki ga je otrok porabil med vajo po 16 tednih zdravljenja.
English: Revatio must not be taken by patients who have ever had a problem with blood flow in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Slovenian: Zdravila Revatio ne smejo jemati bolniki, ki so kadar koli imeli težave z dotokom krvi v oko, imenovanim nearteritična anteriorna ishemična optična nevropatija (NAION).
English: Revatio can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Slovenian: Predpisovanje in izdaja zdravila Revatio je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem pljučne arterijske hipertenzije.
English: Revatio contains the active substance sildenafil.
Slovenian: Zdravilo Revatio vsebuje zdravilno učinkovino sildenafil.
English: In adults who cannot take the tablets or oral suspension, the solution for injection is injected into a vein by a doctor or nurse at a dose of 10 mg (12.5 ml) three times a day.
Slovenian: Odrasli, ki ne morejo jemati tablet ali peroralne suspenzije, prejmejo raztopino za injiciranje v odmerku 10 mg (12,5 ml) trikrat na dan v obliki intravenske injekcije, ki jo daje zdravnik ali medicinska sestra.
English: In children, the most common side effects (which may affect up to 1 patient in 10) are throat and nose infections, headache, vomiting, fever, diarrhoea, flu and nosebleeds.
Slovenian: Najpogostejši neželeni učinki, opaženi pri otrocih (ki lahko prizadenejo do 1 bolnika od 10), so okužbe grla in nosu, glavobol, bruhanje, povišana telesna temperatura, driska, gripa in krvavitve iz nosu.
English: The CHMP concluded that Revatio provides an alternative treatment option for PAH.
Slovenian: Menil je tudi, da zdravilo Revatio pomeni dodatno možnost zdravljenja za bolnike s PAH.
English: Lower doses of Revatio may be needed in patients taking some medicines that affect the way Revatio is broken down in the body.
Slovenian: Pri bolnikih, ki jemljejo nekatera zdravila, ki lahko vplivajo na to, kako se zdravilo Revatio razgradi v telesu, bodo morda potrebni nižji odmerki tega zdravila.
English: For the full list of all side effects reported with Revatio, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Revatio, glejte navodilo za uporabo.
English: In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Slovenian: Sildenafil pri bolnikih s pljučno arterijsko hipertenzijo razširi krvne žile v pljučih, kar zniža krvni tlak in olajša simptome.
English: The most common side effects with Revatio in adults (which may affect more than 1 patient in 10) are headache, flushing (reddening of the skin), dyspepsia (heartburn), diarrhoea and pain in arm or leg. Side effects are similar with the solution for injection.
Slovenian: Najpogostejši neželeni učinki zdravila Revatio (ki lahko prizadenejo več kot 1 bolnika od 10) so glavobol, zardevanje (pordelost kože), dispepsija (zgaga), driska in bolečine v rokah ali nogah.
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Slovenian: Pljučna arterijska hipertenzija je izčrpavajoča bolezen, pri kateri pride do hude konstrikcije (zoženja) krvnih žil v pljučih.
English: After 12 weeks, this distance had increased by 49 m more in the patients taking 20 mg Revatio than in the patients taking placebo.
Slovenian: Po 12 tednih se je pri bolnikih, ki so jemali 20-miligramski odmerek zdravila Revatio, ta razdalja povečala za 49 metrov več kot pri tistih, ki so jemali placebo.
English: This distance had increased by 45 m more in the patients taking 20 mg Revatio than in those taking placebo after 12 weeks.
Slovenian: Pri bolnikih, ki so jemali 20-miligramski odmerek, se je po 12 tednih ta razdalja povečala za 45 metrov več kot pri tistih, ki so jemali placebo.
English: How is Revatio used?
Slovenian: Kako se zdravilo Revatio uporablja?
English: The main study in adults involved 277 patients with PAH, most of whom had class II or class III disease.
Slovenian: V glavno študijo pri odraslih je bilo vključenih 277 bolnikov s pljučno arterijsko hipertenzijo, večina katerih je imela bolezen razreda II ali III. Spremembo v telesni zmogljivosti so merili kot izboljšanje v razdalji, ki jo je bolnik lahko prehodil v šestih minutah po 12 tednih zdravljenja.
English: --1 1 dose (0.2 ml) contains:
Slovenian: --1 1 odmerek (0,2 ml) vsebuje:
English: This product contains a genetically modified organism (GMO).
Slovenian: To cepivo vsebuje gensko spremenjene organizme (GSO).
English: *** fluorescent focus units
Slovenian: *** Fluorescentna fokusna enota
English: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136) 10
Slovenian: A/Vietnam/1203/2004 (H5N1) (A/Vietnam/1203/2004, MEDI 0141000136) 107.0±0.5 FFU***
English: * propagated in fertilised hens' eggs from healthy chicken flocks.
Slovenian: * Namnožen v oplojenih kokošjih jajcih iz jat zdravih piščancev.
English: ** produced in VERO cells by reverse genetic technology.
Slovenian: ** Pridobljen v celicah VERO s tehnologijo reverzne genetike.
English: Reassortant influenza virus* (live attenuated) of the following strain**:
Slovenian: Reasortirani virus gripe* (živ, oslabljen) seva**:
English: 10 sprayers
Slovenian: 10 nosnikov
English: EU/1/16/1089/001 Pandemic influenza vaccine H5N1 AstraZeneca
Slovenian: EU/1/16/1089/001
English: Nasal use sprayer (glass) in trays
Slovenian: Pot uporabe Stična ovojnina
English: (Invented) name
Slovenian: Številka postopka EMA (Izmišljeno) ime
English: • There are alternative treatments available in the EU.
Slovenian: • V EU so na voljo alternativna zdravljenja.
English: • Patients who have any questions or concerns should speak to their healthcare professional.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z zdravnikom.
English: The review of Inductos was initiated on 23 July 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Inductos se je pričel 23. julija 2015 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: It was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Slovenian: Opravil ga je Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja v zvezi z zdravili za uporabo v humani medicini.
English: The CHMP recommendation was sent to the European Commission, which endorsed it and issued a final legally binding decision.
Slovenian: Priporočilo CHMP je bilo poslano Evropski komisiji, ki je priporočilo podprla in izdala končno pravno zavezujočo odločbo.
English: Inductos was authorised centrally in the EU in September 2002.
Slovenian: Zdravilo Inductos je bilo v EU odobreno po centraliziranem postopku septembra 2002.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20/11/2015.
Slovenian: Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 20/11/2015 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.
Slovenian: Inšpektorji so ugotovili, da proizvajalec s sedežem v Združenih državah ne izvaja ustreznih ukrepov za preprečevanje kontaminacije gob z delci.
English: The new bone tissue grows into the sponge, which is gradually degraded by the body.
Slovenian: Novo kostno tkivo raste v gobo, ki jo telo postopoma razgradi.
English: Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process.
Slovenian: Kljub temu da ni znakov tveganja za bolnike, povezanih z ugotovitvami inšpekcijskega pregleda, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA menil, da s sedanjim proizvodnim procesom ni mogoče zagotoviti kakovosti zdravila Inductos.
English: Inductos to be suspended in the EU EMA/683814/2015
Slovenian: Začasen umik dovoljenja za promet z zdravilom Inductos v EU EMA/683814/2015
English: The active substance is dibotermin alfa, a protein that acts on the bone structure and helps with the formation of new bone tissue.
Slovenian: Zdravilna učinkovina je dibotermin alfa, protein, ki deluje na zgradbo kosti in pomaga pri oblikovanju novega kostnega tkiva.
English: • Problems have been identified with the way the absorbable sponge in Inductos is manufactured.
Slovenian: • Ugotovljene so bile težave z načinom proizvodnje absorpcijske gobe pri zdravilu Inductos.
English: Suspension will remain until manufacturing issues are resolved
Slovenian: Umik bo veljal, dokler se ne odpravijo težave v proizvodnji
English: Inductos to be suspended in the EU
Slovenian: Začasen umik dovoljenja za promet z zdravilom Inductos v EU
English: On 22 October 2015, the European Medicines Agency (EMA) recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.
Slovenian: Evropska agencija za zdravila je 22. oktobra 2015 priporočila začasen umik dovoljenja za promet z zdravilom Inductos, vsadkom, ki se uporablja za pomoč pri razvoju novega kostnega tkiva pri bolnikih, ki imajo težave z medvretenčno ploščico, in tistih, ki so utrpeli zlom noge.
English: It is used during surgery in patients with damaged spinal discs or leg (tibia) fractures.
Slovenian: Uporablja se med kirurškim posegom pri bolnikih s poškodovano medvretenčno ploščico ali zlomom noge (golenice).
English: • Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved.
Slovenian: • Kljub temu da ni znakov tveganja za bolnike, je bilo dovoljenje za promet z zdravilom Inductos začasno umaknjeno, kar pomeni, da ne bo več na voljo v EU, dokler se težave, povezane z obratom za proizvodnjo absorpcijske gobe, ne odpravijo.
English: EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements.
Slovenian: Agencija je pregled zdravila Inductos sprožila po inšpekcijskem pregledu, ki so ga opravili nizozemski in španski organi, pri katerem je bilo ugotovljeno, da proizvodni obrat absorpcijske gobe ni skladen s proizvodnimi zahtevami.
English: The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.
Slovenian: CHMP je zato sklenil, da je treba dovoljenje za promet z zdravilom Inductos začasno umakniti, dokler težave v proizvodnji ne bodo zadovoljivo odpravljene.
English: Inductos is available as a kit for implant containing a powder, solvent and absorbable collagen sponge (or matrix).
Slovenian: Zdravilo Inductos je na voljo kot komplet za vsaditev, ki vsebuje prašek, vehikel in absorpcijsko kolagensko gobo (ali matriks).
English: Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.
Slovenian: Umik dovoljenja za promet z zdravilom Inductos bo veljal, dokler se ne odpravijo težave, povezane z obratom, v katerem se proizvaja eden od sestavnih delov zdravila Inductos (absopcijska goba).
English: See sections 4.3, 4.4 and 5.2
Slovenian: Glejte poglavja 4.3, 4.4 in 5.2.
English: Older people
Slovenian: Starejši ljudje
English: If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.
Slovenian: Če ste mlajši od 18 let, uporaba zdravila RILUTEK ni priporočljiva , saj ni na voljo nobenih informacij za to populacijo.
English: date of first authorisation: 10 June 1996 date of last renewal: 10 June 2006
Slovenian: Datum zadnjega podaljšanja: 10. junij 2006
English: IMPORTANT
Slovenian: POMEMBNO
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention: 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: Spodaj našteti neželeni učinki so razvrščeni po pogostosti, po naslednjem dogovoru: 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: Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population.
Slovenian: Na temelju farmakokinetičnih podatkov ni posebnih navodil za uporabo zdravila RILUTEK v tej populaciji.
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje, oznaka ATC: N07XX02.
English: Each package contains 56 tablets.
Slovenian: Eno pakiranje vsebuje 56 tablet.
English: Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease.
Slovenian: Zato se zdravila RILUTEK ne sme uporabljati pri bolnikih z drugimi oblikami bolezni motoričnega nevrona.
English: If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.
Slovenian: Če mislite, da ste noseči, ali če nameravate dojiti, se posvetujte s svojim zdravnikom preden vzamete zdravilo RILUTEK.
English: What you need to know before you take RILUTEK
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo RILUTEK
English: Sanofi Mature IP 54 rue La Boétie 75008 Paris France
Slovenian: Sanofi Mature IP 54 rue La Boétie 75008 Paris Francija
English: Tell your doctor immediately if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells.
Slovenian: Nemudoma obvestite svojega zdravnika, - če imate vročino (zvišanje telesne temperature), saj zdravilo RILUTEK lahko povzroči znižanje števila belih krvnih celic.
English: Safety and efficacy of RILUTEK has only been studied in ALS.
Slovenian: Varnost in učinkovitost zdravila RILUTEK sta bili raziskani le pri ALS.
English: Fertility studies in rats revealed slight impairment of reproductive performance and fertility at doses of 15 mg/kg/day (which is higher than the therapeutic dose), probably due to sedation and lethargy.
Slovenian: Študije plodnosti pri podganah so pokazale rahlo poslabšanje reproduktivne sposobnosti in plodnosti pri odmerkih 15 mg/kg/dan (kar je več od terapevtskega odmerka), verjetno zaradi sedacije in letargije.
English: If you forget to take RILUTEK
Slovenian: Če ste pozabili vzeti zdravilo RILUTEK
English: RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Slovenian: Zdravilo RILUTEK prepreči sproščanje glutamata, kar najbrž pomaga preprečevati poškodbo živčnih celic.
English: Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.
Slovenian: Zvišanje alanin aminotransferaze se je ponavadi pojavilo v 3 mesecih po začetku zdravljenja z riluzolom; ponavadi je bilo prehodno in raven se je med nadaljevanjem zdravljenja znižala na manj kot 2 kratno ULN po 2 do 6 mesecih.
English: What RILUTEK is and what it is used for
Slovenian: Kaj je zdravilo RILUTEK in za kaj ga uporabljamo
English: Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Slovenian: Vsaka tableta vsebuje 50 mg riluzola in ima na eni strani vrezan napis "RPR 202".
English: If you take more RILUTEK than you should
Slovenian: Če ste vzeli večji odmerek zdravila RILUTEK, kot bi smeli
English: Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1).
Slovenian: Klinična preskušanja so pokazala, da zdravilo RILUTEK podaljša preživetje bolnikov z ALS (glejte poglavje 5.1).
English: There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Slovenian: Ni dokazov, da bi zdravilo RILUTEK terapevtsko učinkovalo na motorično funkcijo, pljučno funkcijo, fascikulacije, mišično moč ali motorične simptome.
English: The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. in the morning and evening).
Slovenian: Priporočeni odmerek je ena tableta, dvakrat na dan. Tablete morate zaužiti, na 12 ur, vsak dan ob istem dnevnem času (npr. zjutraj in zvečer).
English: Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Slovenian: Previdnost je potrebna pri predpisovanju riluzola bolnikom z anamnezo motenega delovanja jeter ali bolnikom z nekoliko zvišano ravnjo serumskih transaminaz (ALT/SGPT, AST/SGOT do vrednosti, ki je enaka 3-kratni zgornji meji normalne vrednosti (ULN)), bilirubina in/ali gama-glutamiltransferaze (GGT).
English: Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Slovenian: Zdravljenje z zdravilom RILUTEK sme uvesti samo zdravnik specialist z izkušnjami v zdravljenju bolezni motoričnega nevrona.
English: RILUTEK has not been shown to be effective in the late stages of ALS.
Slovenian: Ni dokazov, da bi zdravilo RILUTEK bilo učinkovito v poznih stadijih ALS.
English: In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
Slovenian: Pri bolnikih, zdravljenih z riluzolom 100 mg/dan, je bilo preživetje značilno večje kot pri bolnikih, ki so dobivali placebo.
English: EU/1/96/010/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/96/010/001
English: RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Slovenian: Zdravilo RILUTEK je indicirano za podaljšanje življenja ali časa do mehanične ventilacije pri bolnikih z amiotrofično lateralno sklerozo (ALS).
English: Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: INFORMATION IN BRAILLE
Slovenian: PODATKI V BRAILLOVI PISAVI RILUTEK
English: The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Slovenian: Primarna presnovna pot riluzola je uvodna oksidacija s citokromom P450 1A2, s čimer nastane Nhidroksiriluzol (RPR112512), glavni aktivni presnovek riluzola.
English: The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people (>70 years).
Slovenian: Farmakokinetični parametri riluzola se po večkratnem odmerjanju (4,5 dni zdravljenja s 50 mg riluzola dvakrat na dan) pri starejših ljudeh (> 70 let) ne spremenijo.
English: What RILUTEK looks like and content of the pack
Slovenian: Izgled zdravila RILUTEK in vsebina pakiranja
English: The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Slovenian: Tablete imajo kapsulam podobno obliko, so bele barve in imajo na eni strani vrezan napis "RPR 202".
English: RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
Slovenian: Zdravilo RILUTEK uporabljamo pri bolnikih z amiotrofično lateralno sklerozo (ALS).
English: RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Slovenian: Zdravila RILUTEK ni priporočljivo uporabljati pri bolnikih z okvarjenim delovanjem ledvic, ker v tej populaciji ni bilo študij s ponavljajočimi odmerki (glejte poglavje 4.4).
English: What RILUTEK is and what it is used for What you need to know before you take RILUTEK How to take RILUTEK
Slovenian: Kaj je zdravilo RILUTEK in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo RILUTEK Kako jemati zdravilo RILUTEK Možni neželeni učinki