FrancophonIA/ELRC3.0 huggingface dataset:
English: The major route of elimination for fampridine is renal excretion, with approximately 90% of the dose recovered in urine as parent medicinal product within 24 hours.
Slovenian: Fampridin se v glavnem izloča skozi ledvice, približno 90 % odmerka se pojavi v urinu v obliki učinkovine v roku 24 ur.
English: leave 12 hours between each tablet
Slovenian: DRUGI PODATKI Razmik 12 ur med vsako tableto
English: Difference (95% CI) p - value
Slovenian: Razlika 95-% IZ vrednost p
English: In this study there was a statistically significant treatment difference, with a greater proportion of Fampyra treated patients demonstrating an improvement in walking ability, compared to placebo-controlled patients (relative risk of 1.38 (95% CI: [1.06, 1.70]).
Slovenian: Večji delež bolnikov, ki so bili zdravljeni z zdravilom Fampyra, je pokazal izboljšanje zmožnosti hoje v primerjavi s kontrolnimi bolniki, ki so prejemali placebo (relativno tveganje 1,38 (95-% IZ: [1,06, 1,70]).
English: In post-marketing experience, there have been reports of hypersensitivity reactions (including anaphylaxis) which have occurred with one or more of the following: dyspnoea, chest discomfort, hypotension, angioedema, rash and urticaria.
Slovenian: Iz izkušenj v obdobju trženja zdravila so poročali o preobčutljivostnih reakcijah (vključno z anafilakso), ki so se izrazile z enim ali več od naslednjega: dispneja, nelagodje v prsih, hipotenzija, angioedem, izpuščaj in urtikarija.
English: In overdose you may notice sweating, minor shaking (tremor), confusion, memory loss (amnesia) and fits (seizure).
Slovenian: V primerih prevelikega odmerjanja lahko opazite potenje, blago tresenje (tremor), zmedenost, izgubo spomina (amnezijo) in napade krčev (epileptične napade).
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Slovenian: Prins Mauritslaan 13
English: • Fast heart rate (tachycardia)
Slovenian: • hiter srčni utrip (tahikardija)
English: As a precautionary measure it is preferable to avoid the use of Fampyra in pregnancy.
Slovenian: Kot previdnostni ukrep se uporaba zdravila Fampyra ne priporoča med nosečnostjo.
English: For further information on seizure risk, please refer to sections 4.3 and 4.4.
Slovenian: Za več informacij o tveganju epileptičnega napada glejte poglavji 4.3 in 4.4.
English: If you are pregnant, or are planning to become pregnant, tell your doctor before you take Fampyra Fampyra is not recommended during pregnancy.
Slovenian: Če ste noseči ali načrtujete nosečnost, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Slovenian: Zdravilo Fampyra je indicirano za izboljšanje hoje pri odraslih bolnikih z multiplo sklerozo z nezmožnostjo hoje (EDSS 4-7).
English: What Fampyra looks like and contents of the pack
Slovenian: Izgled zdravila Fampyra in vsebina pakiranja
English: • Minor shaking (tremor)
Slovenian: • blago tresenje (tremor)
English: Fampyra should be discontinued in patients who experience a seizure while on treatment.
Slovenian: Uporabo zdravila Fampyra je treba prekiniti pri bolnikih, ki med zdravljenjem doživijo epileptični napad.
English: Caution is required when Fampyra is prescribed concurrently with medicinal products that are substrates of OCT2 for example, carvedilol, propanolol and metformin.
Slovenian: Pozornost je potrebna, če se zdravilo Fampyra predpiše sočasno z zdravili, ki so substrati OCT2, na primer karvedilol, propanolol in metformin.
English: What you need to know before you take Fampyra Do not take Fampyra
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Fampyra
English: If your Fampyra is supplied in bottles, only one bottle should be opened at a time.
Slovenian: Če ste prejeli zdravilo Fampyra v plastenki, odprite samo eno plastenko hkrati.
English: DATE OF REVISION OF THE TEXT
Slovenian: Izhodišče Končna točka Sprememba
English: Re-Evaluating Fampyra Treatment
Slovenian: Ponovno ovrednotenje zdravljenja z zdravilom Fampyra
English: Concurrent treatment with other medicinal products containing fampridine (4-aminopyridine) is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba z drugimi zdravili, ki vsebujejo fampridin (4-aminopiridin), je kontraindicirana (glejte poglavje 4.3).
English: Hypromellose Titanium dioxide (E-171) Polyethylene glycol 400
Slovenian: hipromeloza titanov dioksid (E-171) makrogol 400
English: The increased incidence of dizziness and balance disorder seen with Fampyra may result in an increased risk of falls.
Slovenian: Pri zdravljenju z zdravilom Fampyra so opazili večjo incidenco omotice in motenj ravnotežja, kar lahko povzroči povečano tveganje za padec.
English: This may increase your risk of side effects.
Slovenian: To lahko zveča tveganje neželenih učinkov.
English: Fampridine is eliminated primarily by the kidneys as unchanged medicinal product and therefore renal function should be checked in patients where renal function might be compromised.
Slovenian: Primarna pot izločanja fampridina je skozi ledvice v obliki nespremenjene učinkovine, zato je treba pri bolnikih, kjer obstaja možnost okvarjenega delovanja ledvic, preveriti ledvično funkcijo.
English: Do not divide, crush, dissolve, suck or chew the tablet.
Slovenian: Tablet ne lomite, ne drobite, ne raztapljajte, ne sesajte in ne žvečite.
English: Fampyra is an off-white, film coated, oval biconvex 13 x 8 mm prolonged-release tablet with A10 on one side.
Slovenian: Zdravilo Fampyra je belkasta, filmsko obložena, ovalna bikonveksna 13 x 8 mm tableta s podaljšanim sproščanjem z vtisom A10 na eni strani.
English: The 3-hydroxylation of fampridine to 3-hydroxy-4-aminopyridine by human liver microsomes appeared to be catalyzed by Cytochrome P450 2E1 (CYP2E1).
Slovenian: Kaže, da je katalizator 3-hidroksilacije fampridina v 3-hidroksi-4-aminopiridin v mikrosomih človeških jeter citokrom P450 2E1 (CYP2E1).
English: An off-white, film coated, oval biconvex 13 x 8 mm tablet with flat edge debossed with A10 on one side.
Slovenian: Belkasta, filmsko obložena, ovalna bikonveksna 13 x 8 mm tableta z ravnim robom in vtisom A10 na eni strani.
English: Central nervous system side effects at high doses of 4-aminopyridine include confusion, seizures, status epilepticus, involuntary and choreoathetoid movements.
Slovenian: Neželeni učinki na osrednji živčni sistem pri velikih odmerkih 4-aminopiridina vključujejo zmedenost, epileptične napade, status epileptikus, nehotne in horeoatetotične zgibke.
English: Store the tablets in the original packaging in order to protect from light and moisture.
Slovenian: Tablete shranjujte v originalnem pakiranju za zagotovitev zaščite pred svetlobo in vlago.
English: Fampyra is primarily excreted unchanged by the kidneys, and with creatinine clearance known to decrease with age, monitoring of renal function in older patients should be considered (see section 4.2).
Slovenian: Primarna pot izločanja zdravila Fampyra je v nespremenjeni obliki skozi ledvice; ker je znano, da očistek kreatinina s starostjo upada, je treba pri starejših bolnikih razmisliti o nadziranju delovanja ledvic (glejte poglavje 4.2).
English: Fampyra is a medicine used to improve walking in adults (18 years and over) with Multiple Sclerosis (MS) related walking disability.
Slovenian: Zdravilo Fampyra se uporablja za izboljšanje hoje pri odraslih bolnikih (starih 18 let in več) z multiplo sklerozo (MS) z nezmožnostjo hoje.
English: 1 See section 4.4 2 These symptoms were observed in the context of hypersensitivity
Slovenian: 2Te simptome so opazili v sklopu preobčutljivosti.
English: Talk to your doctor or pharmacist before taking Fampyra:
Slovenian: Pred začetkom jemanja zdravila Fampyra se posvetujte z zdravnikom ali farmacevtom:
English: Detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Each bottle contains 14 tablets and a silica gel desiccant.
Slovenian: Ena plastenka vsebuje 14 tablet in sušilno sredstvo iz silikagela.
English: • Difficulty breathing (shortness of breath)
Slovenian: • težave z dihanjem (zasoplost)
English: Leave the desiccant in the bottle, do not swallow it.
Slovenian: Sušilno sredstvo pustite v plastenki in ga ne zaužijte.
English: How to take Fampyra
Slovenian: Kako jemati zdravilo Fampyra
English: Foil blisters (aluminium / aluminium), each blister tray contains 14 tablets.
Slovenian: Pretisni omoti s folijo (aluminij/aluminij), vsak podstavek pretisnega omota vsebuje 14 tablet.
English: A significantly greater proportion of Fampyra treated patients were responders as compared to placebo (MS-F203: 34.8% vs. 8.3%, p<0.001; MS-F204: 42.9% vs. 9.3%, p<0.001).
Slovenian: Delež odziva je bil značilno višji pri bolnikih, zdravljenih z zdravilom Fampyra, v primerjavi z bolniki, ki so prejemali placebo (MS-F203: 34,8 % v primerjavi z 8,3 %, p < 0,001; MS-F204:
English: If your Fampyra is supplied in bottles, the bottle will also contain a desiccant.
Slovenian: Če ste prejeli zdravilo Fampyra v plastenki, bo le-ta vsebovala tudi sušilno sredstvo.
English: Renal function should be checked in older people before starting treatment with Fampyra.
Slovenian: Pred začetkom zdravljenja z zdravilom Fampyra je treba pri starejših ljudeh preveriti delovanje ledvic.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: izhodišče izboljšanje od izhodišča (s)
English: In patients with renal impairment, accumulation occurs relative to the degree of impairment.
Slovenian: Pri bolnikih z okvaro ledvic se učinkovina kopiči sorazmerno s stopnjo okvare.
English: Biogen Belgium N.V./S.A.
Slovenian: Luxembourg/Luxemburg Biogen Belgium N.V./S.A.
English: Adverse reactions identified are mostly neurological and include seizure, insomnia, anxiety, balance disorder, dizziness, paraesthesia, tremor, headache and asthenia.
Slovenian: Večina opredeljenih neželenih učinkov je bilo nevroloških in vključujejo epileptične napade, insomnijo, tesnobo, motnje ravnotežja, omotico, parestezijo, tremor, glavobol in astenijo.
English: You must leave 12 hours between each tablet.
Slovenian: Med vsako tableto mora miniti 12 ur.
English: Elimination:
Slovenian: Izločanje
English: Hypersensitivity Reactions
Slovenian: Preobčutljivostne reakcije
English: In this secondary endpoint, a greater proportion of Fampyra treated patients achieved ≥ 15% mean improvement from baseline TUG speed over a 24 week period, compared to placebo.
Slovenian: Ta sekundarni cilj študije je dosegel večji delež bolnikov, zdravljenih z zdravilom Fampyra: v primerjavi s skupino, ki je prejemala placebo, je skupina, zdravljena z zdravilom Fampyra, v 24-tedenskem obdobju dosegla ≥ 15-odstotno povprečno izboljšanje hitrosti TUG.
English: Fampyra should not be administered to patients with renal impairment (creatinine clearance <80 ml/min) (see section 4.3).
Slovenian: Zdravila Fampyra se ne sme dajati bolnikom z okvaro ledvic (očistek kreatinina < 80 ml/min) (glejte poglavje 4.3).
English: Fampyra comes in HDPE (high-density polyethylene) bottles.
Slovenian: Zdravilo Fampyra je pakirano v plastenkah iz HDPE (polietilen visoke gostote).
English: HDPE (high-density polyethylene) bottle with polypropylene caps, each bottle contains 14 tablets and a silica gel desiccant.
Slovenian: Plastenka iz HDPE (polietilen visoke gostote) s polipropilensko zaporko; ena plastenka vsebuje 14 tablet in sušilno sredstvo iz silikagela.
English: Starting and Evaluating Fampyra Treatment
Slovenian: Začetek zdravljenja z zdravilom Fampyra in ovrednotenje
English: No pharmacological activity was found for the fampridine metabolites against selected potassium channels in vitro.
Slovenian: In vitro niso ugotovili farmakološke aktivnosti presnovkov fampridina na izbrane kalijeve kanalčke.
English: MSIS-29 physical score
Slovenian: Rezultat MSIS-29 telesno funkcioniranje izhodišče izboljšanje od izhodišča
English: Swallow each tablet whole, with a drink of water.
Slovenian: Zaužijte celo tableto z vodo.
English: Acute symptoms of overdose with Fampyra were consistent with central nervous system excitation and included confusion, tremulousness, diaphoresis, seizure, and amnesia.
Slovenian: Akutni simptomi prevelikega odmerjanja zdravila Fampyra so v skladu z vzburjenjem osrednjega živčnega sistema in vključujejo zmedenost, drhtenje, diaforezo, epileptične napade in amnezijo.
English: Patients with hepatic impairment No dose adjustment is required for patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter ni treba prilagajati odmerka.
English: Fampyra must not be administered to patients with mild, moderate and severe renal impairment (see section 4.3).
Slovenian: Zdravila Fampyra se ne sme dajati bolnikom z blago, zmerno ali hudo okvaro ledvic (glejte poglavje 4.3).
English: Biogen Finland Oy Puh/Tel: +358 207 401 200
Slovenian: Puh/Tel: +358 207 401 200
English: Monitoring renal function to detect any renal impairment is recommended in older people (see section 4.4).
Slovenian: Pri starejših ljudeh se priporoča nadziranje delovanja ledvic, da se odkrije morebitna okvara ledvic (glejte poglavje 4.4).
English: Store the tablets in the original bottle in order to protect from light and moisture.
Slovenian: Tablete shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: Gait abnormalities and hyper-excitability were also observed.
Slovenian: Opazili so tudi nenormalnosti v hoji in pretirano vzdražljivost.
English: • If you have any further questions, ask your doctor or pharmacist.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Studies MS-F203 and MS-F204
Slovenian: Študiji MS-F203 in MS-F204
English: Determining renal function before treatment and its regular monitoring during treatment is recommended in all patients (particularly in older people in whom renal function might be reduced).
Slovenian: Pri vseh bolnikih (zlasti pri starejših, pri katerih je delovanje ledvic lahko zmanjšano), se priporoča ugotavljanje delovanja ledvic pred zdravljenjem in redno nadziranje med zdravljenjem.
English: Walking speed Feet/sec
Slovenian: Hitrost hoje čevljev/sek
English: • Common cold (nasopharyngitis)
Slovenian: • navadni prehlad (nazofaringitis)
English: − Tablet core: hypromellose, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate; film coat: hypromellose, titanium dioxide (E-171), polyethylene glycol 400
Slovenian: magnezijev stearat; filmska obloga: hipromeloza, titanov dioksid (E-171), makrogol 400
English: Urinary tract infection1 Influenza1
Slovenian: Infekcijske in parazitske bolezni infekcija sečnega trakta1 gripa1 nazofaringitis1
English: The Fampyra dose was 10 mg BID.
Slovenian: Odmerek zdravila Fampyra je bil 10 mg dvakrat na dan.
English: Fampyra may have an effect on people's ability to drive or use machines, it can cause dizziness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Fampyra lahko vpliva na sposobnost upravljanja vozil in strojev, ker povzroča omotico.
English: Treatment with Fampyra is restricted to prescription and supervision by physicians experienced in the management of MS.
Slovenian: Zdravljenje z zdravilom Fampyra, ki se izdaja na zdravniški recept, mora nadzirati zdravnik z izkušnjami v obvladovanju MS.
English: Distribution:
Slovenian: Porazdelitev
English: Τηλ: +30 210 8771500
Slovenian: Genesis Pharma SA Τηλ: +30 210 8771500
English: Hypotension2
Slovenian: Žilne bolezni hipotenzija2
English: CI95%
Slovenian: Razlika 95-% IZ
English: Biogen GmbH Tel: +49 (0) 89 99 6170
Slovenian: Tel: +49 (0) 89 99 6170
English: Make sure you're not affected before you start driving or use machinery.
Slovenian: Preden vozite ali upravljate stroje, se prepričajte, da to za vas ne velja.
English: • Feeling unsteady
Slovenian: • občutek nestabilnosti
English: Fampyra is contraindicated in patients with mild, moderate and severe renal impairment (creatinine clearances <80 ml/min) (see section 4.3).
Slovenian: Zdravilo Fampyra je kontraindicirano pri bolnikih z blago, zmerno ali hudo okvaro ledvic (očistek kreatinina <80 ml/min) (glejte poglavje 4.3).
English: Fampyra is not recommended during breast-feeding.
Slovenian: Jemanje zdravila Fampyra med dojenjem ni priporočljivo.
English: Infections were seen in the clinical studies (see section 4.8) and increased infection rate and impairment of the immune response cannot be excluded.
Slovenian: V kliničnih študijah (glejte poglavje 4.8) so bile opažene infekcije.
English: points from baseline MSWS-12 score
Slovenian: Rezultat lestvice MSWS-12 izhodišče izboljšanje od izhodišča
English: − Each prolonged-release tablet contains 10 mg of fampridine
Slovenian: − Ena tableta s podaljšanim sproščanjem vsebuje 10 mg fampridina
English: Consistent improvement
Slovenian: Število oseb (n) Konsistentno izboljšanje
English: België/Belgique/Belgien
Slovenian: België/Belgique/Belgien Biogen Belgium N.V./S.A.
English: Fampyra is for oral use.
Slovenian: Zdravilo Fampyra se jemlje peroralno.
English: Each pack contains 28 tablets (2 blisters) or 56 tablets (4 blisters).
Slovenian: Vsako pakiranje vsebuje 28 tablet (2 pretisna omota) ali 56 tablet (4 pretisni omoti).
English: EU/1/11/699/003 28 tablets EU/1/11/699/004 56 tablets
Slovenian: EU/1/11/699/004 56 tablet
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Slovenian: PODATKI , KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Very Common side effects
Slovenian: Zelo pogosti neželeni učinki
English: Very Common Common
Slovenian: zelo pogosti pogosti pogosti pogosti
English: Missed Dose
Slovenian: Izpuščeni odmerek
English: EU/1/11/699/001 28 tablets EU/1/11/699/002 56 tablets
Slovenian: EU/1/11/699/002 56 tablet
English: Baseline 69.27 (2.22) Average change -0.01 (1.46) Difference p-value LEMMT (mean, sem) (Lower Extremity Manual Muscle Test) Baseline 3.92 (0.070) Average change 0.05 (0.024) Difference p-value Ashworth Score (A test for muscle spasticity)
Slovenian: spremembe Razlika vrednost p Rezultat MSWS-12 (povprečje, SNP) Izhodišče 69,27 (2,22) Povprečna sprememba -0,01 (1,46)
English: Fampyra comes in foil blisters of 14 tablets each.
Slovenian: Zdravilo Fampyra je pakirano v pretisnih omotih iz folije, vsak omot vsebuje 14 tablet.
English: Fampyra is a potassium channel blocker.
Slovenian: Zdravilo Fampyra je zaviralec kalijevih kanalčkov.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za peroralno uporabo
English: If you take more Fampyra than you should Contact your doctor immediately if you take too many tablets.
Slovenian: Če ste vzeli preveč tablet, se takoj obrnite na zdravnika.
English: Fampyra is supplied in either blister packs or bottles.
Slovenian: Zdravilo Fampyra je na voljo v pretisnih omotih ali plastenkah.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: − Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Biogen Idec Limited Tel: +44 (0) 1628 50 1000
Slovenian: Tel: +44 (0) 1628 50 1000
English: Fampyra should be discontinued if patients no longer receive walking benefit.
Slovenian: Jemanje zdravila Fampyra je treba prekiniti pri bolnikih, kjer ni opaznih izboljšav pri hoji.
English: A double dose should not be taken if a dose is missed.
Slovenian: Če bolnik odmerek izpusti, ne sme uporabiti dvojnega.
English: • Heartbeat that you can feel (palpitations)
Slovenian: • zavedanje bitja svojega srca (palpitacije)
English: Blister packs
Slovenian: Biogen GmbH
English: Fampyra is supplied in either bottles or blister packs.
Slovenian: Zdravilo Fampyra je na voljo v plastenkah ali pretisnih omotih.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu pogosti
English: 28 prolonged-release tablets (2 blisters of 14 tablets each) 56 prolonged-release tablets (4 blisters of 14 tablets each)
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 tablet s podaljšanim sproščanjem (2 pretisna omota po 14 tablet) 56 tablet s podaljšanim sproščanjem (4 pretisni omoti po 14 tablet)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA S PRETISNIM OMOTOM
English: Nausea Vomiting Constipation Dyspepsia
Slovenian: Bolezni prebavil navzea bruhanje obstipacija dispepsija pogosti pogosti pogosti pogosti
English: Pack size of 56 (4 bottles of 14) tablets.
Slovenian: Velikost pakiranja 56 tablet (4 plastenke po 14 tablet).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 14 tablet s podaljšanim sproščanjem
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA S PLASTENKO
English: Alkermes Pharma Ireland Ltd Monksland
Slovenian: Ime in naslov proizvajalcev, odgovornih za sproščanje serij Alkermes Pharma Ireland Ltd
English: Palpitations
Slovenian: Plastenke
English: Method of Administration
Slovenian: POSTOPEK UPORABE
English: Dyspnoea Pharyngolaryngeal pain
Slovenian: Shranjevanje zdravila Fampyra
English: Pack size of 56 (4 blisters of 14) tablets.
Slovenian: Velikost pakiranja 56 tablet (4 pretisni omoti po 14 tablet).
English: Fampyra 10 mg prolonged-release tablets
Slovenian: IME ZDRAVILA Fampyra 10 mg tablete s podaljšanim sproščanjem
English: Fampyra 10 mg prolonged-release tablets fampridine
Slovenian: IME ZDRAVILA Fampyra 10 mg tablete s podaljšanim sproščanjem fampridin
English: Pack size of 28 (2 bottles of 14) tablets.
Slovenian: Velikost pakiranja 28 tablet (2 plastenki po 14 tablet).
English: BBS score
Slovenian: ŠTEVILKA SERIJE Serija
English: Pack size of 28 (2 blisters of 14) tablets.
Slovenian: Velikost pakiranja 28 tablet (2 pretisna omota po 14 tablet).
English: Immune system disorders
Slovenian: Organski sistemi po MedDRA Neželeni učinek
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Take the Fampyra box with you if you go to see the doctor.
Slovenian: Če greste k zdravniku, vzemite škatlo zdravila Fampyra s seboj.
English: Sun.
Slovenian: SN
English: − because this medicine may make you feel dizzy or unsteady this may result in an increased risk of falls
Slovenian: − če uporabljate pripomoček za hojo, na primer palico, ker ste lahko zaradi tega zdravila omotični ali nestabilni.
English: Each prolonged-release tablet contains 10 mg of fampridine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta s podaljšanim sproščanjem vsebuje 10 mg fampridina.
English: Each tablet contains 10 mg of fampridine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg fampridina.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja faringolaringealna bolečina pogosti pogosti
English: Seizure risk
Slovenian: − Navodilo shranite.
English: Wed. Thu.
Slovenian: TOR SRE ČET PET SOB NED
English: Τηλ: +357 22 765740
Slovenian: Genesis Pharma (Cyprus) Ltd Τηλ: +357 22 765740
English: 14 prolonged-release tablets
Slovenian: FARMACEVTSKA OBLIKA tableta s podaljšanim sproščanjem
English: Gastrointestinal disorders
Slovenian: Manual Muscle Test)
English: • This medicine has been prescribed for you only.
Slovenian: − Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Package leaflet: information for the user Fampyra 10mg prolonged-release tablets fampridine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Fampyra 10 mg tablete s podaljšanim sproščanjem fampridin peroralna uporaba
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj urtikarija občasni občasni
English: Tachycardia
Slovenian: • tesnoba
English: Improvement from baseline (sec)
Slovenian: LEMMT (povprečje, SNP) (Lower Extremity