FrancophonIA/ELRC3.0 huggingface dataset:
English: There are limited amount of data from the use of fampridine in pregnant women.
Slovenian: Podatki o uporabi fampridina pri nosečnicah so omejeni.
English: If you forget to take a tablet, do not take two tablets at once to make up for a missed dose.
Slovenian: Če ste pozabili vzeti prejšnjo tableto, ne vzemite dvojnega odmerka, da bi nadoknadili izpuščeni odmerek.
English: By blocking potassium channels, Fampyra reduces the leakage of ionic current through these channels, thereby prolonging repolarization and thus enhancing action potential formation in demyelinated axons and neurological function.
Slovenian: Z zaviranjem kalijevih kanalčkov zdravilo Fampyra zmanjša pretok ionov skozi te kanalčke, kar podaljša repolarizacijo in s tem poveča nastajanje akcijskega potenciala demieliniziranih aksonov in nevroloških funkcij.
English: Study 218MS305
Slovenian: Študija 218MS305
English: The European Medicines Agency has waived the obligation to submit the results of studies with Fampyra in all subsets of the paediatric population in treatment of multiple sclerosis with walking disability (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Fampyra za vse podskupine pediatrične populacije za zdravljenje multiple skleroze z nezmožnostjo hoje (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Fampyra 10 mg BID N = 315*
Slovenian: Fampyra 10 mg dvakrat na dan n = 315*
English: In a battery of in vitro and in vivo studies fampridine did not show any potential to be mutagenic, clastogenic or carcinogenic.
Slovenian: V nizu raziskav in vitro in in vivo fampridin ni pokazal mutagenega, klastogenega ali karcinogenega potenciala.
English: − if you have a seizure or have ever had a seizure (also referred to as a fit or convulsion)
Slovenian: − če imate ali ste kadarkoli imeli epileptični napad (imenovan tudi krč ali konvulzija).
English: Absolute bioavailability of Fampyra prolonged-release tablets has not been assessed, but relative bioavailability (as compared to an aqueous oral solution) is 95%.
Slovenian: Absolutna biološka razpoložljivost zdravila Fampyra tablete s podaljšanim sproščanjem ni bila ocenjena; njegova relativna biološka razpoložljivost (v primerjavi z vodno peroralno raztopino) pa je 95 %.
English: They work by stopping potassium leaving the nerve cells which have been damaged by MS.
Slovenian: Zaviralci preprečijo kaliju, da zapusti živčne celice, ki jih je MS poškodovala.
English: Treatment of cultured human hepatocytes with fampridine had little or no effect on induction of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2E1 or CYP3A4/5 enzyme activities.
Slovenian: Zdravljenje gojenih humanih hepatocitov s fampridinom ima majhen ali ničen učinek na indukcijo aktivnosti encimov CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2E1 ali CYP3A4/5.
English: Fampyra should not be administered more frequently or at higher doses than recommended (see section 4.4).
Slovenian: Zdravila Fampyra se ne sme dajati pogosteje ali v višjih odmerkih od priporočenih (glejte poglavje 4.4).
English: Patients with mild renal impairment can be expected to have approximately 1.7 to 1.9 times the fampridine concentrations achieved by patients with normal renal function.
Slovenian: Pri bolnikih z blago okvaro ledvic je možno pričakovati približno 1,7- do 1,9-kratno koncentracijo fampridina v primerjavi z bolniki z normalnim delovanjem ledvic.
English: Fampridine is largely unbound to plasma proteins (bound fraction varied between 3-7% in human plasma).
Slovenian: Fampridin se večinoma ne veže na beljakovine v plazmi (frakcija vezave v človeški plazmi niha med 3-7 %).
English: Fampyra treated patients also demonstrated a statistically significant improvement in the Timed Up and Go (TUG) test, a measure of static and dynamic balance and physical mobility.
Slovenian: Pri bolnikih, ki so bili zdravljeni z zdravilom Fampyra, se je pokazalo tudi statistično značilno izboljšanje pri časovno merjenem testu, imenovanem »vstani in pojdi« (Timed Up and Go - TUG), ki je merilo za statično in dinamično ravnotežje in fizično gibljivost.
English: Fampyra is characterized by linear (dose-proportional) pharmacokinetics with a terminal elimination half-life of approximately 6 hours.
Slovenian: Za zdravilo Fampyra je značilna linearna (z odmerkom sorazmerna) farmakokinetika s končno razpolovno dobo izločanja približno 6 ur.
English: May affect up to 1 in 100 people
Slovenian: Pojavijo se lahko pri največ 1 od 100 bolnikov
English: Faecal excretion accounts for less than 1% of the administered dose.
Slovenian: Izločanje z blatom predstavlja manj kot 1 % danega odmerka.
English: ANNEX II A. MANUFACTURERS(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: The tablet must be swallowed whole.
Slovenian: Tablete je treba pogoltniti cele.
English: 43% Risk difference: 9.2%
Slovenian: razlika tveganja: 9,2 %
English: • An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four weeks.
Slovenian: • Izboljšanje ocene sposobnosti hoje z npr. časovno omejeno hojo na 25 čevljev (= 7,62 m) (T25FW - Timed 25 Foot Walk) ali 12-stopenjsko lestvico hoje za multiplo sklerozo (MSWS-12 - Twelve Item Multiple Sclerosis Walking Scale), je priporočljivo ovrednotiti po dveh do štirih tednih.
English: Do not take Fampyra if you are taking any other medicine containing fampridine.
Slovenian: Ne uporabljajte zdravila Fampyra, če jemljete druga zdravila, ki vsebujejo fampridin.
English: If you forget to take Fampyra
Slovenian: Če ste pozabili vzeti zdravilo Fampyra
English: In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo.
Slovenian: V kliničnih študijah so ugotovili zmanjšano število belih krvničk pri 2,1 % bolnikov, zdravljenih z zdravilom Fampyra, in pri 1,9 % pri bolnikih, ki so prejemali placebo.
English: If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of Fampyra (see above).
Slovenian: Če zdravnik opazi zmanjšanje sposobnosti hoje, mora razmisliti o prekinitvi zdravljenja in ponovnem ovrednotenju koristi zdravljenja z zdravilom Fampyra (glejte zgoraj).
English: Hypersensitivity to fampridine or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na fampridin ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: There was evidence of direct inhibition of CYP2E1 by fampridine at 30 μM (approximately 12% inhibition) which is approximately 100 times the average plasma fampridine concentration measured for the 10 mg tablet.
Slovenian: Dokazali so, da fampridin neposredno zavira CYP2E1 pri 30 μM (približno 12 % zaviranje), kar je približno 100-krat povprečna koncentracija fampridina v plazmi, izmerjeno za 10 mg tablete.
English: Orally administered fampridine is rapidly and completely absorbed from the gastrointestinal tract.
Slovenian: Peroralno uporabljen fampridin se hitro in v celoti absorbira iz prebavnega trakta.
English: Fampridine was studied in oral repeat dose toxicity studies in several animal species.
Slovenian: Zdravilo Fampridine so preučili v študijah toksičnosti pri ponavljajočih se odmerkih s peroralnim dajanjem pri več živalskih vrstah.
English: The re-evaluation should include withdrawal of Fampyra and performing an assessment of walking ability.
Slovenian: Ponovno ovrednotenje mora zajemati prenehanje jemanja zdravila Fampyra in izvedbo ocene sposobnosti hoje.
English: The primary endpoint in studies MS-F203 and MS-F204 was the responder rate in walking speed as measured by the Timed 25-foot Walk (T25FW).
Slovenian: Primarna končna točka v študijah MS-F203 in MS-F204 je bila stopnja odziva v hitrosti hoje, izmerjena s časovno omejeno hojo na 25 čevljev (= 7,62 m) (T25FW - Timed 25 Foot Walk).
English: Fampyra should be administered with caution to patients with cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in overdose).
Slovenian: Zdravilo Fampyra je treba dajati previdno bolnikom s kardiovaskularnimi simptomi motenj ritma in sinoatrijskega ali atrioventrikularnega prevajanja (ti učinki se pojavijo pri prevelikem odmerjanju).
English: In addition, single cases of fatal urinary tract obstructions were observed in rats.
Slovenian: Poleg tega so pri podganah opazili tudi posamezne primere fatalne obstrukcije sečil.
English: When Fampyra tablets are taken with food, the reduction in the area under the plasma concentrationtime curve (AUC0-∞) of fampridine is approximately 2-7% (10 mg dose).
Slovenian: Pri uporabi tablet zdravila Fampyra s hrano je zmanjšanje površine pod krivuljo plazemske koncentracije v odvisnosti od časa (AUC0-∞) fampridina približno 2-7 % (10 mg odmerek).
English: Your doctor will be especially careful if fampridine is given at the same time as any medicine which may affect how your kidneys eliminate medicines for example carvedilol, propanolol and metformin.
Slovenian: Vaš zdravnik bo še posebej previden, če jemljete fampridin sočasno z drugim zdravilom, ki lahko vpliva na način, kako vaše ledvic izločajo zdravila, na primer karvedilol, propanolol in metformin.
English: The Fampyra prolonged-release tablet has a delay in the absorption of fampridine manifested by slower rise to a lower peak concentration, without any effect on the extent of absorption.
Slovenian: Zdravilo Fampyra tablete s podaljšanim sproščanjem ima zakasnjeno absorpijo fampridina, kar se kaže v počasnejšem naraščanju do nižje najvišje koncentracije, kar pa nima učinka na obseg absorpcije.
English: In reproduction toxicity studies in rats and rabbits, decreased weight and viability of foetuses and offspring were observed at maternally toxic doses.
Slovenian: V študijah toksičnosti za razmnoževanje pri podganah in kuncih so opazili zmanjšanje telesne mase in manjšo viabilnost zarodkov in potomstva pri odmerkih, ki so bili toksični za mater.
English: Statistically and clinically meaningful improvements in walking were seen, as measured by the 12item Multiple Sclerosis Walking Scale.
Slovenian: Opazili so statistično in klinično pomembna izboljšanja v hoji, merjeno z 12-stopenjsko lestvico hoje za multiplo sklerozo.
English: Repeated seizure activity should be treated with benzodiazepine, phenytoin, or other appropriate acute anti-seizure therapy.
Slovenian: Ponavljajoča se aktivnost epileptičnih napadov se zdravi z benzodiazepinom, fenitoinom ali drugim ustreznim akutnim zdravljenjem proti epileptičnim napadom.
English: Fampridine is metabolised in humans by oxidation to 3-hydroxy-4-aminopyridine and further conjugated to the 3-hydroxy-4-aminopyridine sulfate.
Slovenian: Fampridin se pri ljudeh presnavlja z oksidacijo v 3-hidroksi-4-aminopiridin in se nato konjugira do 3-hidroksi-4-aminopiridin sulfata.
English: Since there is a clear relationship between Cmax and dose related adverse reactions, it is recommended to take Fampyra without food (see section 4.2).
Slovenian: Ker ni jasnega razmerja med Cmax in neželenimi učinki, odvisnimi od odmerka, se priporoča jemanje zdravila Fampyra brez hrane (glejte poglavje 4.2).
English: If you have a seizure, stop taking Fampyra and tell your doctor immediately.
Slovenian: Če imate epileptični napad, prenehajte uporabljati zdravilo Fampyra in takoj obvestite zdravnika.
English: • Numbness or tingling of skin
Slovenian: • otrplost ali mravljinčenje kože
English: Fampyra should be administered with caution in the presence of any factors which may lower seizure threshold.
Slovenian: Zdravilo Fampyra je treba dajati previdno v prisotnosti vsakršnih dejavnikov, ki bi lahko znižali prag epileptičnih napadov.
English: Other medicines and Fampyra
Slovenian: Druga zdravila in zdravilo Fampyra
English: You should not breast-feed whilst taking this medicine.
Slovenian: Med jemanjem tega zdravila ne smete dojiti.
English: May affect up to 1 in 10 people:
Slovenian: Pojavijo se lahko pri več kot 1 od 10 bolnikov:
English: The tablets should be taken without food (see section 5.2).
Slovenian: Tablete se morajo jemati brez hrane (glejte poglavje
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki na zdravilo navedeni po padajoči resnosti.
English: Fampridine is eliminated mainly via the kidneys with active renal secretion accounting for about 60% (see section 5.2).
Slovenian: Fampridin se pretežno izloča prek ledvic z aktivnim ledvičnim izločanjem, ki znaša približno 60 % (glejte poglavje 5.2).
English: − if you are taking any other medicine containing fampridine.
Slovenian: − če jemljete katerokoli drugo zdravilo, ki vsebuje fampridin.
English: What Fampyra is and what it is used for What you need to know before you take Fampyra How to take Fampyra
Slovenian: Kaj je zdravilo Fampyra in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Fampyra Kako jemati zdravilo Fampyra Možni neželeni učinki
English: Fampyra is only available by prescription and under the supervision of doctors experienced in MS.
Slovenian: Zdravilo Fampyra je na voljo le na zdravniški recept in pod nadzorom zdravnika z izkušnjami z MS.
English: Patients who overdose should be provided supportive care.
Slovenian: Bolnike, ki prejmejo preveliki odmerek, je treba oskrbeti s podporno nego.
English: If no improvement is observed, Fampyra should be discontinued
Slovenian: Če ni opaznega izboljšanja, je treba uporabo zdravila Fampyra prekiniti.
English: In multiple sclerosis, inflammation destroys the protective sheath around the nerves leading to muscle weakness, muscle stiffness and difficulty walking.
Slovenian: Pri multipli sklerozi vnetje uniči zaščitno ovojnico, ki obdaja živce, in povzroči mišično oslabelost, togost mišic in težave s hojo.
English: You can get a larger print version of this leaflet by calling the local representatives (see list below).
Slovenian: Vsebina pakiranja in dodatne informacije V primeru, da želite dobiti večji izpis tega navodila, pokličite lokalnega predstavnika (glejte spodnji seznam).
English: Biogen Hungary Kft. Tel.: +36 (1) 899 9883
Slovenian: Magyarország Biogen Hungary Kft. Tel.: +36 (1) 899 9883
English: Concomitant use of Fampyra with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
Slovenian: Sočasna uporaba zdravila Fampyra z zdravili, ki zavirajo organske kationske prenašalce 2 (OCT2Organic Cation Transporter 2), na primer cimetidin.
English: For further information on hypersensitivity reactions, please refer to sections 4.3 and 4.4.
Slovenian: Za več informacij o preobčutljivostnih reakcijah glejte poglavji 4.3 in 4.4.
English: Interferon: fampridine has been administered concomitantly with interferon-beta and no pharmacokinetic medicinal product interactions were observed.
Slovenian: Interferon: fampridin so dajali sočasno z interferonom beta, pri čemer niso opazili farmakokinetičnih interakcij med zdravili.
English: Fampyra has a moderate influence on the ability to drive and use machines because Fampyra can cause dizziness.
Slovenian: Zdravilo Fampyra ima zmeren vpliv na sposobnost vožnje in upravljanja strojev, ker lahko zdravilo Fampyra povzroči omotico.
English: Adverse responses to orally administered fampridine were rapid in onset, most often occurring within the first 2 hours post-dose.
Slovenian: Neželeni učinki pri peroralni uporabi fampridina so se pokazali hitro, običajno v prvih 2 urah po odmerku.
English: Absorption:
Slovenian: Absorpcija
English: Your doctor will consider the benefit of you being treated with Fampyra against the risk to your baby.
Slovenian: Zdravnik bo ocenil prednosti zdravljenja z zdravilom Fampyra z morebitnimi tveganji za otroka.
English: − if you have any factors or are taking any medicine which affects your risk of fits (seizure).
Slovenian: − če imate druge dejavnike ali jemljete zdravila, ki lahko vplivajo na tveganje napadov krčev
English: The proportion of responders was independent of concomitant immunomodulatory therapy (including interferons, glatiramer acetate, fingolimod and natalizumab).
Slovenian: Delež bolnikov, ki so se odzivali na zdravljenje, je bil neodvisen od sočasnega imunomodulacijskega zdravljenja (ki je vključevalo interferone, glatiramer acetat, fingolimod in natalizumab).
English: Therefore, patients should use walking aids as needed.
Slovenian: Bolniki naj zato uporabljajo pripomočke za hojo.
English: Three phase III, randomised, double-blind, placebo controlled confirmatory studies, (MS-F203 and MS-F204 and 218MS305) have been performed.
Slovenian: V fazi III kliničnega preizkušanja zdravila so opravili tri randomizirane, dvojno slepe, s placebom kontrolirane potrditvene študije (MS-F203, MS-F204 in 218MS305).
English: Fampyra is primarily excreted unchanged by the kidneys.
Slovenian: Zdravilo Fampyra se primarno izloča nespremenjeno skozi ledvice.
English: The primary endpoint was improvement in walking ability, measured as the proportion of patients achieving a mean improvement of ≥ 8 points from baseline MSWS-12 score over 24 weeks.
Slovenian: Primarni cilj študije je bil izboljšanje zmožnosti hoje, merjen kot delež bolnikov, ki so dosegli povprečno izboljšanje za ≥ 8 točk od izhodišča na lestvici MSWS-12 v 24 tednih.
English: Patients with prior history or current presentation of seizure.
Slovenian: Bolniki z anamnezo ali obstoječimi epileptičnimi napadi.
English: Patients who responded to Fampyra increased their walking speed on average by 26.3% vs 5.3% on placebo (p<0.001) (MS-F203) and 25.3% vs 7.8% (p< 0.001) (MS-F204).
Slovenian: Bolniki, ki so se odzivali na zdravilo Fampyra, so v povprečju povečali hitrost svoje hoje za 26,3 % v primerjavi s 5,3 % pri bolnikih na placebu (p < 0,001) (MS-F203) in 25,3 % v primerjavi s 7,8 % (p < 0,001) (MS-F204).
English: In addition, patients treated with Fampyra demonstrated a statistically significant mean improvement from baseline compared to placebo in the Multiple Sclerosis Impact Scale (MSIS-29) physical score (LSM difference -3.31, p<0.001).
Slovenian: Poleg tega se je pri bolnikih, ki so bili zdravljeni z zdravilom Fampyra, pokazalo statistično značilno povprečno izboljšanje od izhodišča v primerjavi s placebom pri rezultatu po lestvici vpliva posledic multiple skleroze na telesno funkcioniranje (Multiple Sclerosis Impact Scale - MSIS-29) (razlika LSM -3,31, p<0,001).
English: Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine).
Slovenian: Sočasno zdravljenje z drugimi zdravili, ki vsebujejo fampridin (4-aminopiridin).
English: Table 2: Study 218MS305
Slovenian: Preglednica 2: Študija 218MS305
English: Biogen Portugal Sociedade Farmacêutica Unipessoal, Lda
Slovenian: Portugal Biogen Portugal Sociedade Farmacêutica
English: Biogen Austria GmbH Tel: +43 1 484 46 13
Slovenian: Österreich Biogen Austria GmbH Tel: +43 1 484 46 13
English: There is no evidence of clinically relevant accumulation of fampridine taken at the recommended dose in patients with full renal function.
Slovenian: Ni dokazov klinično pomembnega kopičenja fampridina pri priporočenih odmerkih za bolnike z neokvarjenim delovanjem ledvic.
English: Baseline 0.98 (0.078) Average change -0.09 (0.037) Difference p-value
Slovenian: Izhodišče 0,98 (0,078) Povprečna sprememba -0,09 (0,037)
English: • Fampyra should be discontinued if benefit is not reported by patients.
Slovenian: • Uporabo zdravila Fampyra je treba prekiniti pri bolnikih, ki ne poročajo o napredku.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali s farmacevtom.
English: Baclofen: fampridine has been administered concomitantly with baclofen and no pharmacokinetic medicinal product interactions were observed.
Slovenian: Baklofen: fampridin so dajali sočasno z baklofenom, pri čemer niso opazili farmakokinetičnih interakcij med zdravili.
English: Fampyra contains the active substance fampridine which belongs to a group of medicines called potassium channel blockers.
Slovenian: Zdravilo Fampyra vsebuje učinkovino fampridin, ki sodi v skupino zdravil, imenovanih zaviralci kalijevih kanalčkov.
English: Proportion of patients with mean improvement of ≥ 15%
Slovenian: Delež bolnikov s povprečnim izboljšanjem ≥ 15 % hitrosti pri TUG
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Treatment with fampridine increases seizure risk (see section 4.8).
Slovenian: Zdravljenje s fampridinom povečuje tveganje epileptičnih napadov (glejte poglavje 4.8).
English: The highest incidence of adverse reactions identified from placebocontrolled trials in multiple sclerosis patients with Fampyra given at the recommended dose, are reported as urinary tract infection (in approximately 12% of patients).
Slovenian: O največji incidenci neželenih učinkov, opredeljenih v s placebom nadzorovanih preskušanjih, pri bolnikih, ki so bili zdravljeni s priporočenim odmerkom zdravila Fampyra, so poročali pri okužbah sečil (pri približno 12 % bolnikov).
English: Clinical signs evident after large single doses or repeated lower doses were similar in all species studied and included tremors, convulsions, ataxia, dyspnoea, dilated pupils, prostration, abnormal vocalization, increased respiration, and excess salivation.
Slovenian: Klinični znaki, ki so se pokazali po velikih posameznih odmerkih ali po ponavljajočih se manjših odmerkih, so si bili pri vseh preučevanih živalskih vrstah podobni in so vključevali tremorje, konvulzije, ataksijo, dispnejo, razširjene zenice, prostracijo, abnormalno vokalizacijo, hitrejše dihanje in povečano izločanje sline.
English: Thus, the concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, cimetidine are contraindicated (see section 4.3) and concomitant use of fampridine with medicinal products that are substrates of OCT2 for example, carvedilol, propanolol and metformin is cautioned (see section 4.4.)
Slovenian: Zato je sočasna uporaba fampridina z zdravili, ki so zaviralci OCT2, na primer cimetidin, kontraindicirana (glejte poglavje 4.3), medtem ko je pri sočasni uporabi fampridina z zdravili, ki so substrati OCT2, kot so na primer karvedilol, propanolol in metformin, potrebna previdnost (glejte poglavje 4.4).
English: Fampridine is a lipid-soluble medicinal product which readily crosses the blood-brain barrier.
Slovenian: Fampridin je v maščobi topno zdravilo, ki hitro prehaja skozi krvno-možgansko pregrado.
English: − if you have kidney problems
Slovenian: − če imate težave z ledvicami.
English: Patients with mild, moderate or severe renal impairment (creatinine clearances <80 ml/min).
Slovenian: Bolniki z blago, zmerno ali hudo okvaro ledvic (očistki kreatinina < 80 ml/min).
English: Hypromellose Microcrystalline cellulose Silica, colloidal anhydrous Magnesium stearate
Slovenian: hipromeloza mikrokristalna celuloza silicijev dioksid, koloidni, brezvodni magnezijev stearat
English: Table 1: Studies MS-F203 and MS-F204 STUDY *
Slovenian: Preglednica 1: Študiji MS-F203 in MS-F204 ŠTUDIJA*
English: After first opening use within 7 days.
Slovenian: Po prvem odprtju plastenke porabite v 7 dneh.