FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of memantine with the antispasmodic medicinal products, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Icelandic: Samtímis gjöf memantíns og krampalosandi efnanna, dantrólens eða baklófens, getur breytt áhrifum þeirra og leiðrétting á skammti kann að vera nauðsynleg.
English: This effect is known from other active substances with cationic amphiphilic properties.
Icelandic: Þessi áhrif eru þekkt hjá öðrum virkum efnum með katjóníska vatns- og fitusækni eiginleika.
English: France Sandoz
Icelandic: Sandoz
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
Icelandic: NAFN MARKAÐSLEYFISHAFA Pharmathen S.A.
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 mL/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Icelandic: Hjá sjálfboðaliðum með óskerta nýrnastarfsemi er heildarúthreinsun (Cltot) um 170 ml/mín./1,73 m2 og hluti heildarúthreinsunar úr nýrum næst með píplaseytingu.
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%,p<0.0001).
Icelandic: á öllum þremur sviðum kom fram hjá sjúklingum, sýndu niðurstöður tölfræðilega marktæk áhrif memantíns í að draga úr versnun, þar sem tvisvar sinnum fleiri sjúklingar sem meðhöndlaðir voru með lyfleysu en þeir sem fengu memantín, sýndu versnun á öllum sviðunum þremur (21% á móti 11%, p<0,0001).
English: p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Icelandic: Alzheimer sjúkdómi - athöfnum daglegs lífs (ADCS-ADLsev): p=0,003; alvarleg skerðing (SIB): p=0,002).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM ÞYNNUPAKKNING MEÐ TÖFLUM
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.
Icelandic: Sé svo þarf að fylgjast grannt með meðferðinni og læknirinn þarf að meta reglulega klínískan ábata af töku Memantine LEK.
English: Memantine LEK belongs to a group of medicines known as anti-dementia medicines.
Icelandic: Memantine LEK tilheyrir flokki lyfja sem kallaður er lyf við heilabilun.
English: Sandoz d.d Representative office Teл.
Icelandic: Sandoz d.d. representative office Latvia.
English: 1Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Icelandic: 1Ofskynjanir hafa aðallega komið fram hjá sjúklingum með alvarlegan Alzheimers-sjúkdóm.
English: Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Icelandic: Ekki er mælt með því að börn og unglingar undir 18 ára aldri noti Memantine LEK.
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 mL/min) no dose adjustment is required.
Icelandic: Hjá sjúklingum með lítillega skerta nýrnastarfsemi (kreatínín úthreinsun 50-80 ml/mín.) er ekki þörf á að breyta skammtinum.
English: Treatment of adult patients with moderate to severe Alzheimer's disease.
Icelandic: Meðferð hjá fullorðnum sjúklingum sem haldnir eru miðlungs til alvarlegum Alzheimers-sjúkdómi.
English: No adverse reactions of memantine were noted on male and female fertility.
Icelandic: Engar aukaverkanir af memantíni komu fram á frjósemi karla og kvenna.
English: What Memantine LEK is and what it is used for
Icelandic: Upplýsingar um Memantine LEK og við hverju það er notað
English: How to store Memantine LEK Contents of the pack and other information
Icelandic: Memantine LEK Pakkningar og aðrar upplýsingar
English: Memantine LEK should be administered orally once a day.
Icelandic: Memantine LEK til inntöku einu sinni á dag.
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer's disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Icelandic: Hjá sjúklingum sem meðhöndlaðir voru með memantíni komu fram tölfræðilega marktækt betri áhrif en hjá sjúklingum sem meðhöndlaðir voru með lyfleysu við aðalendapunkta: skali varðandi mat á Alzheimer sjúkdómi (ADAS-cog) (p=0,003) og CIBIC-plus (p=0,004) í 24. viku, síðustu athugun haldið áfram (LOCF).
English: What is Memantine LEK used for Memantine LEK is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Icelandic: Memantine LEK er notað við meðferð fullorðinn sjúklinga sem haldnir eru miðlungs til alvarlegum Alzheimers-sjúkdómi.
English: one and a half 10 mg tablets week 4 and beyond two 10 mg tablets or one 20 mg tablet once a day
Icelandic: Tvær 10 mg töflur eða ein 20 mg tafla einu sinni á dag
English: Memantine LEK belongs to a group of medicines called NMDA-receptor antagonists.
Icelandic: Memantine LEK tilheyrir lyfjahópi sem nefnist NMDA-viðtakablokkar.
English: amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
Icelandic: Áhrif eftirtalinna lyfja kunna að breytast við notkun Memantine LEK og læknir kann að þurfa að endurskoða skammtinn sem notaður er af þeim: - amantadín, ketamín, dextrómetorfan - dantrólen, baklófen - címetidín, ranitídín, prókaínamíð, kínidín, kínín, nikótín - hýdróklórtíazíð (eða lyfjablöndur sem innihalda hýdróklórtíazíð) - andkólínvirk lyf (lyf sem almennt eru notuð við hreyfitruflunum eða iðrakveisu) - krampalosandi lyf (lyf sem eru notuð við og til að fyrirbyggja krampaköst) - barbítúrefni (svefnlyf) - dópamínvirk efni (efni eins og L-dópa og brómókriptín) - sefandi lyf (notuð við geðtruflunum) - blóðþynningarlyf til inntöku
English: The recommended maintenance dose is 20 mg per day.
Icelandic: Ráðlagður viðhaldsskammtur er 20 mg á dag.
English: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, iron oxide yellow (E172) and iron oxide red (E-172)
Icelandic: Pólývínýl alkóhól , makrógól 3350, títan díoxíð (E 171), talkúm, gult járnoxíð (E 172), rautt járnoxíð (E 172)
English: Memantine LEK is for oral use.
Icelandic: Memantine LEK er til inntöku.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Icelandic: Rannsóknin sýndi gagnleg áhrif memantínmeðferðar í samanburði við lyfleysu eftir sex mánuði þar sem breytingar voru metnar af lækni byggt á viðtölum við sjúklinga („observed cases analysis for the clinician´s interview based impression of change“ (CIBIC-plús)): p= 0,025; í samstarfsrannsókn á Alzheimer sjúkdómi - athöfnum daglegs lífs (ADCS-ADLsev): p=0,003; alvarleg skerðing (SIB): p=0,002).
English: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Icelandic: Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, EL-69300 Rodopi, Grikkland
English: This medicine does not require any special storage conditions.
Icelandic: Engin sérstök fyrirmæli eru um geymslu lyfsins.
English: Tablet core: croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate
Icelandic: Örkristallaður sellulósi, natríum kroskarmellósa,vatnsfrí kísilkvoða og magnesíumsterat
English: Adverse reactions are ranked according to system organ class, using the following convention: very common
Icelandic: Aukaverkanir eru settar upp samkvæmt líffærakerfum og eru eftirfarandi viðmið notuð:
English: Memantine LEK 20 mg film-coated tablets are presented as pale red, oval film-coated tablet scored in one side.
Icelandic: Memantine LEK 20 mg filmuhúðaðar töflur eru ljósrauðar, egglaga filmuhúðaðar töflur með deilistriki á annari hliðinni.
English: Polyvinyl alcohol Macrogol 3350
Icelandic: Makrógól 3350
English: Sandoz Pharmaceuticals d.d.
Icelandic: Sandoz Pharmaceuticals d.d. Tel:
English: 2Isolated cases reported in post-marketing experience.
Icelandic: 2 Skýrt hefur verið frá einstaka tilvikum eftir að lyfið kom á markað.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki= inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Icelandic: Við 20 mg dagskammt memantíns er magn í mænuvökva (CSF) í samræmi við ki-gildi (ki = hömlunarfasti) memantíns, sem er 0,5 µmól í framanverðum heilaberki manna.
English: days, more than 99% being excreted renally.
Icelandic: skammtsins út innan 20 daga, þar af voru rúm 99% útskilin um nýru.
English: Administration of Memantine LEK is not recommended in patients with severe hepatic impairment.
Icelandic: Ekki er mælt með lyfjagjöf Memantine LEK hjá sjúklingum með alvarlega skerta lifrarstarfsemi.
English: Verovškova 57, 1526 Ljubljana Slovenia
Icelandic: Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slóvenía
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substance - active substance interaction of memantine with glyburide/metformin or donepezil was observed.
Icelandic: Í einskammta lyfjahvarfarannsóknum hjá ungum, heilbrigðum einstaklingum komu ekki fram neinar milliverkanir sem máli skipta milli virku efnanna memantíns og glýbúríðs/metformíns eða dónezepíls.
English: Memantine LEK contains the active substance memantine hydrochloride.
Icelandic: Memantine LEK inniheldur virka efnið memantínhýdróklóríð.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician's interview based impression of change (CIBIC-plus):
Icelandic: Rannsóknin sýndi gagnleg áhrif memantínmeðferðar í samanburði við lyfleysu eftir sex mánuði þar sem breytingar voru metnar af lækni byggt á viðtölum við sjúklinga („observed cases analysis for the clinician´s interview based impression of change“ (CIBIC-plús)): p= 0,025; í samstarfsrannsókn á
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Icelandic: VIÐAUKI II A. FRAMLEIÐANDI SEM ER ÁBYRGUR FYRIR LOKASAMÞYKKT B. FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN C. AÐRAR FORSENDUR OG SKILYRÐI MARKAÐSLEYFIS D. FORSENDUR EÐA TAKMARKANIR
English: INFORMATION IN BRAILLE Memantine LEK 10 mg
Icelandic: MEÐ BLINDRALETRI Memantine LEK 10 mg
English: 10 mg: Film-coating: polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350 and iron oxide yellow (E
Icelandic: Pólývínýl alkóhól, makrógól 3350, títan díoxíð (E 171), talkúm, gult járnoxíð (E 172)
English: INFORMATION IN BRAILLE Memantine LEK 20 mg
Icelandic: MEÐ BLINDRALETRI Memantine LEK 20 mg
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
Icelandic: Hjá sjúklingum með miðlungs skerta nýrnastarfsemi (kreatínín úthreinsun 30 - 49 ml/mín.)
English: Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Icelandic: Memantine LEK hefur áhrif á NMDA-viðtakana og bætir sendingu taugaboða ásamt minni.
English: Each 10 mg tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Icelandic: Hver 10 mg tafla inniheldur 10 mg af memantínhýdróklóríði, samsvarandi 8,31 mg af memantíni.
English: Pale red, oval film-coated tablet scored in one side.
Icelandic: Ljósrauðar, egglaga filmuhúðaðar töflur með deilistriki á annari hliðinni.
English: Each 20 mg tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Icelandic: Hver 20 mg tafla inniheldur 10 mg af memantínhýdróklóríði, samsvarandi 16,62 mg af memantíni.
English: Women taking Memantine LEK should not breast-feed.
Icelandic: Memantine LEK ættu ekki að hafa barn á brjósti.
English: Tablet coat
Icelandic: Pólývínýl alkóhól
English: The patient should take one 20 mg film-coated tablet (20 mg) per day for 7 days.
Icelandic: Sjúklingurinn skal taka eina 20 mg filmuhúðaða töflu á dag í 7 daga.
English: In patients with severe renal impairment (creatinine clearance 5 - 29 mL/min) daily dose should be 10 mg per day.
Icelandic: Hjá sjúklingum með mjög skerta nýrnastarfsemi (kreatínín úthreinsun 5 - 29 ml/mín.)
English: Do not take Memantine LEK
Icelandic: Ef gleymist að taka Memantine LEK
English: In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
Icelandic: Til þess að draga úr hættu af aukaverkunum er farið upp í þennan skammt með því að fylgja eftirfarandi meðferðarskema: vika 1
English: EU/1/13/826 /007 28 film-coated tablets EU/1/13/826 /008 30 film-coated tablets EU/1/13/826 /009 42 film-coated tablets EU/1/13/826 /010 56 film-coated tablets EU/1/13/826 /011 98 film-coated tablets EU/1/13/826 /015 100 film-coated tablets
Icelandic: EU/1/13/826 /007 28 filmuhúðaðar töflur EU/1/13/826 /008 30 filmuhúðaðar töflur EU/1/13/826 /009 42 filmuhúðaðar töflur EU/1/13/826 /010 56 filmuhúðaðar töflur EU/1/13/826 /011 98 filmuhúðaðar töflur EU/1/13/826 /015 100 filmuhúðaðar töflur
English: Memantine LEK 20 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 56, 98 and 100 tablets.
Icelandic: Memantine LEK 20 mg filmuhúðaðar töflur fást í PVC/PVDC- Ál þynnupökkum sem innihalda 28, 30, 42, 56, 98 og 100 töflur.
English: Slovenská republika Sandoz d.d.
Icelandic: Slovenská republika Sandoz d.d. organizacna zlozka Tel:
English: België/Belgique/Belgien Sandoz n.v./s.a.
Icelandic: België/Belgique/Belgien
English: Other medicines and Memantine LEK
Icelandic: Memantine LEK og pakkningastærðir
English: Memantine LEK 10 mg film-coated tablets are available in PVC/PVDC-Aluminium blister packs of 28, 30, 42, 50, 56, 60, 98, 100 and 112 tablets.
Icelandic: Memantine LEK 10 mg filmuhúðaðar töflur fást í PVC/PVDC- Ál þynnupökkum sem innihalda 28, 30, 42, 50, 56, 60, 98, 100 og 112 töflur.
English: What Memantine LEK looks like and contents of the pack Memantine LEK 10 mg film-coated tablets are presented as yellow, oval film-coated tablet scored in one side.
Icelandic: Memantine LEK 10 mg filmuhúðaðar töflur eru gular, egglaga filmuhúðaðar töflur með deilistriki á annari hliðinni.
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets
Icelandic: Memantine LEK 10 mg filmuhúðaðar töflur
English: PHARMACEUTICAL FORM Film-coated tablet.
Icelandic: 50 filmuhúðaðar töflur.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Icelandic: VIRK(T) EFNI Hver filmuhúðuð tafla inniheldur 10 mg af memantínhýdróklóríði, samsvarandi 8,31 mg af memantíni.
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 50, 56, 60, 98, 100 and 112 film-coated tablets.
Icelandic: Ál -PVC/PVDC þynnupakkningar í pappaöskjum sem innihalda 28, 30, 42, 50, 56, 60, 98, 100 og 112 filmuhúðaðar töflur.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐANDI SEM ER ÁBYRGUR FYRIR LOKASAMÞYKKT
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets memantine hydrochloride
Icelandic: Memantine LEK 20 mg filmuhúðaðar töflur memantínhýdróklóríð
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Icelandic: Lykilrannsókn á einlyfjameðferð var gerð hjá samtals 252 sjúklingum utan stofnana með miðlungs til alvarlegan Alzheimers-sjúkdóm (heildarstigatala vitræns mats (MMSE) við grunngildi 3-14).
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 20 mg film-coated tablets
Icelandic: Memantine LEK 20 mg filmuhúðaðar töflur.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Icelandic: Memantine LEK Látið lækninn eða lyfjafræðing vita um önnur lyf sem eru notuð eða hafa nýlega verið notuð, einnig þau sem fengin eru án lyfseðils.
English: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini, Attiki Greece
Icelandic: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini, Attiki Grikkland
English: NAME OF THE MEDICINAL PRODUCT Memantine LEK 10 mg film-coated tablets memantine hydrochloride
Icelandic: Memantine LEK 10 mg filmuhúðaðar töflur memantínhýdróklóríð
English: Aluminium-PVC/PVDC blisters placed into cardboard boxes containing 28, 30, 42, 56, 98 and 100 filmcoated tablets.
Icelandic: Ál -PVC/PVDC þynnupakkningar í pappaöskjum sem innihalda 28, 30, 42, 56, 98 og 100 filmuhúðaðar töflur.
English: Pharmathen S.A. 6, Dervenakion str. 15351 Pallini, Attiki Greece
Icelandic: Pharmathen S.A. 6, Dervenakion str. 15351 Pallini, Attiki Grikkland
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
Icelandic: Hver filmuhúðuð tafla inniheldur 20 mg af memantínhýdróklóríði (samsvarandi 16.62 mg af memantíni).
English: EXPIRY DATE EXP
Icelandic: Lifur og gall
English: If you take more Memantine LEK than you should - In general, taking too much Memantine LEK should not result in any harm to you.
Icelandic: - Almennt ætti ekki að stafa hætta af því að taka of mikið af Memantine LEK.
English: Yellow, oval film-coated tablet scored in one side.
Icelandic: Gular egglaga filmuhúðaðar töflur með deilistriki á annari hliðinni.
English: • The active substance is memantine hydrochloride.
Icelandic: Virka innihaldsefnið er memantínhýdróklóríð.
English: Manufacturers Pharmathen S.A , 6, Dervenakion str., 15351 Pallini, Attiki, Greece
Icelandic: Framleiðendur Pharmathen S.A., 6 Dervenakion str., 15351 Pallini, Attiki, Grikkland
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Icelandic: Hver filmuhúðuð tafla inniheldur 20 mg af memantínhýdróklóríði, samsvarandi 16,62 mg af memantíni.
English: Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
Icelandic: Memantine LEK og þannig dregið úr hæfni til aksturs og stjórnunar véla.
English: What Memantine LEK contains
Icelandic: Mematine LEK inniheldur
English: Frequency
Icelandic: Skammtatítrun
English: Fertility
Icelandic: Lota
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: YTRI UMBÚÐUM YTRI UMBÚÐUM
English: How does Memantine LEK work
Icelandic: Við hverju er Memantine LEK notað
English: Dose
Icelandic: Samantekt
English: You may experience increased symptoms as described in section 4 “Possible side effects”.
Icelandic: Yfirleitt verður vart aukinna einkenna af því tagi sem lýst er í 4. kafla:
English: Maintenance dose
Icelandic: Hvernig geyma
English: In post-marketing experience these reactions have been reported in patients treated with memantine.
Icelandic: Tilvik um þetta hafa verið tilkynnt hjá sjúklingum í meðferð með memantíni eftir að lyfið kom á markað.
English: Over 24 weeks
Icelandic: Á 24 vikum
English: However, Cmax increases by 15-23%.
Icelandic: Hins vegar hækkar Cmax um 15-23%.
English: There is limited safety information in these patients.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um öryggi fyrir þessa sjúklinga.
English: Leave the desiccant in the bottle, do not swallow it.
Icelandic: Skildu rakadræga efnið eftir í glasinu, ekki kyngja því.
English: Make sure you're not affected before you start driving or use machinery.
Icelandic: Vertu viss um að þú finnir ekki fyrir áhrifum þegar þú byrjar að aka eða nota vélar.
English: ≥20% improvement
Icelandic: ≥20% ávinningur
English: Children and in adolescents
Icelandic: Börn og unglingar
English: Do not take more than two tablets in a day.
Icelandic: Ekki taka fleiri en tvær töflur á dag.
English: Do not give Fampyra to children or adolescents under the age of 18 years.
Icelandic: Fampyra á ekki að gefa börnum eða unglingum undir 18 ára aldri.
English: • Difficulty sleeping
Icelandic: Erfiðleikar með svefn
English: • Feeling weak and tired
Icelandic: Máttleysi og þreyta
English: The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun Fampyra hjá börnum á aldrinum 0 til 18 ára.
English: 43% Risk difference: 10.4%
Icelandic: 43% Áhættumunur: 10,4%
English: − if you are taking a medicine called cimetidine
Icelandic: − ef þú tekur lyf sem kallast címetidín
English: Study 218MS305
Icelandic: Rannsókn 218MS305
English: − you should use a walking aid, such as a cane, as needed
Icelandic: − þú ættir að nota gönguhjálpartæki, svo sem staf, eftir þörfum
English: Placebo N = 318*
Icelandic: Lyfleysa N = 318*
English: The tablets should be taken without food (see section 5.2).
Icelandic: Töflurnar á að taka án matar (sjá kafla 5.2).
English: Difference (95% CI) p - value
Icelandic: Mismunur (95% CI) p - gildi
English: You can get a larger print version of this leaflet by calling the local representatives (see list below).
Icelandic: Hægt er að fá stærri útprentun á þessum fylgiseðli með því að hringja í fulltrúa á hverjum stað (sjá lista hér að neðan).
English: Fampyra with food and drink
Icelandic: Fampyra með mat eða drykk
English: MSIS-29 physical score
Icelandic: MSIS-29 líkamleg einkunn
English: You should not breast-feed whilst taking this medicine.
Icelandic: Þú ættir ekki að hafa barn á brjósti á meðan þú tekur þetta lyf.
English: − The other ingredients are:
Icelandic: Önnur innihaldsefni eru:
English: Therefore, patients should use walking aids as needed.
Icelandic: Sjúklingar ættu því að nota gönguhjálpartæki eins og þörf er á.
English: Duration of double-blind treatment was 24 weeks with a 2 week post-treatment follow-up.
Icelandic: Lengd tvíblindu meðferðarinnar var 24 vikur með eftirfylgni 2 vikum eftir meðferð.
English: Study 218MS305 was conducted in 636 subjects with multiple sclerosis and walking disability.
Icelandic: Rannsókn 218MS305 var gerð hjá 636 þátttakendum með heila- og mænusigg og gönguröskun.
English: The difference in the Berg Balance Scale (BBS; a measure of static balance), was not statistically significant.
Icelandic: Mismunurinn á Berg Balance-mælikvarða (BBS, mælikvarða á kyrrstöðujafnvægi) var ekki tölfræðilega marktækur.
English: Frequencies 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); not known (cannot be estimated from the available data).
Icelandic: Tíðni er skilgreind sem: mjög algengar (≥1/10), algengar (≥1/100 til < 1/10), sjaldgæfar (≥1/1.000 til <1/100), mjög sjaldgæfar (≥1/10.000 til <1/1.000), koma örsjaldan fyrir (<1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: One tablet in the morning and one tablet in the evening (12 hours apart).
Icelandic: Ein tafla að morgni og ein tafla að kvöldi (með 12 klukkustunda millibili).
English: Tell your doctor before you take Fampyra if any of these apply to you.
Icelandic: Láttu lækninn vita áður en þú tekur Fampyra ef eitthvað af þessu á við um þig.
English: Creatinine clearance can be estimated using the Cockroft-Gault formula.
Icelandic: Hægt er að meta kreatínínhreinsun með Cockroft-Gault formúlu.