FrancophonIA/ELRC3.0 huggingface dataset:
English: Elimination was absorption rate limited (flip-flop kinetics), which explains the longer t½ after transdermal patch (3.4 h) versus oral or intravenous administrations (1.4 to 1.7 h).
Icelandic: Brotthvarf takmarkaðist af frásogshraða („flip-flop“ lyfjahvörf), sem skýrir lengri helmingunartíma eftir notkun forðaplásturs (3,4 klst.) samanborið við inntöku eða gjöf í bláæð (1,4 til 1,7 klst.).
English: - The patch should not be cut into pieces.
Icelandic: - Ekki skal klippa plásturinn í sundur.
English: Otherwise treatment should be re-initiated with 4.6 mg/24 h.
Icelandic: Að öðrum kosti skal hefja meðferðina að nýju með 4,6 mg/24 klst.
English: The 48-week results for the two assessment tools are summarised in Table 4.
Icelandic: Í töflu 4 er samantekt á niðurstöðum eftir 48 vikur, á grundvelli þessara tveggja mælikvarða.
English: Rivastigmine capsules 12 mg/day
Icelandic: Rivastigmin hylki 12 mg/sólarhring
English: There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer's disease.
Icelandic: Notkun Rivastigmine 3M Health Care Ltd. á ekki við hjá börnum sem meðferð við Alzheimerssjúkdómi.
English: Take off the previous patch before putting ONE new patch on.
Icelandic: Fjarlægið eldri plásturinn áður en NÝR plástur er settur á.
English: In animals, rivastigmine crosses the placenta and is excreted into milk.
Icelandic: Rivastigmin fer yfir fylgju og berst í mjólk hjá dýrum.
English: EU/1/14/911/001 [7 pouches] EU/1/14/911/002 [30 pouches] EU/1/14/911/003 [60 pouches] EU/1/14/911/004 [90 pouches]
Icelandic: EU/1/14/911/001 [7 pokar] EU/1/14/911/002 [30 pokar] EU/1/14/911/003 [60 pokar] EU/1/14/911/004 [90 pokar]
English: Rivastigmine 13.3 mg/24 h
Icelandic: Rivastigmin 13.3 mg/24 klst.
English: Not known (frequency cannot be estimated from the available data) - Allergic reaction where the patch was used, such as blisters or inflamed skin - The signs of Parkinson's disease get worse - such as tremor, stiffness and shuffling - Inflammation of the pancreas - signs include serious upper stomach pain, often with feeling sick
Icelandic: Tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum) - Ofnæmisviðbrögð í húð undan plástrinum svo sem blöðrumyndun eða húðbólga - Einkenni Parkinsonsveiki versna - svo sem skjálfti, stífleiki og sjúklingar draga fætur við göngu
English: Most skin reactions were limited to the application site and resulted in discontinuation in only 2.4% of the patients in the rivastigmine 9.5 mg/24 h transdermal patch group.
Icelandic: Flest húðviðbrögðin voru staðbundin við plásturssstað og aðeins 2,4% þeirra sem voru í rivastigmin 9,5 mg/24 klst. forðaplástra hópnum hættu í rannsókninni vegna þeirra.
English: The 24-week results for the three assessment tools are summarised in Table 2.
Icelandic: Í töflu 2 er yfirlit yfir niðurstöður eftir 24 vikur, á grundvelli þessara þriggja mælikvarða.
English: If you forget to use Rivastigmine 3M Health Care Ltd.
Icelandic: Ef gleymist að nota Rivastigmine 3M Health Care Ltd.
English: In massive overdose, atropine can be used.
Icelandic: Nota má atropin við alvarlegri ofskömmtun.
English: The exposure to rivastigmine and its metabolites was approximately equivalent to human exposure with highest doses of rivastigmine capsules and transdermal patches.
Icelandic: Útsetning fyrir rivastigmini og umbrotsefnum þess var u.þ.b. samvarandi útsetningu hjá mönnum eftir stærstu skammta rivastigmins við notkun hylkja og forðaplástra.
English: - Renal impairment: Patients with clinically significant renal impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Icelandic: Vera má að sjúklingar með klínískt marktækt skerta nýrnastarfsemi fái frekar aukaverkanir (sjá kafla 4.2 og 5.2).
English: No specific interaction studies have been performed with Rivastigmine 3M Health Care Ltd. transdermal patches.
Icelandic: Ekki hafa verið gerðar neinar sértækar rannsóknir á milliverkunum með Rivastigmine 3M Health Care Ltd. forðaplástrum.
English: - Fast or uneven heartbeat - High blood pressure - Fits (seizures) - Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite) - Changes in tests which show how well the liver is working - Feeling restless
Icelandic: - Lifrarsjúkdómar (gulleit húð, gulnun hvítunnar í augunum, óeðlilega dökkt þvag eða óútskýrð ógleði, uppköst, þreyta og lystarleysi)
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF Lesið fylgiseðilinn fyrir notkun.
English: Cardiac disorders Uncommon Not known
Icelandic: Húð og undirhúð Algengar Tíðni ekki þekkt
English: Name and address of the manufacturer responsible for batch release
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT Heiti og heimilisfang framleiðenda sem eru ábyrgir fyrir lokasamþykkt Enestia
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Icelandic: Ef ekki er ljóst hvernig nota á lyfið skal leita upplýsinga hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum.
English: EU/1/14/911/005 [7 pouches] EU/1/14/911/006 [30 pouches] EU/1/14/911/007 [60 pouches] EU/1/14/911/008 [90 pouches]
Icelandic: EU/1/14/911/005 [7 pokar] EU/1/14/911/006 [30 pokar] EU/1/14/911/007 [60 pokar] EU/1/14/911/008 [90 pokar]
English: - The patch should not be exposed to any external heat sources (e.g. excessive sunlight, saunas,
Icelandic: - Plásturinn má ekki verða fyrir hita í langan tíma frá neinum utanaðkomandi hitagjöfum (t.d.
English: Patients and caregivers should be instructed accordingly.
Icelandic: Veita skal sjúklingum og umönnunaraðilum upplýsingar varðandi þessi atriði.
English: Mean change at week 24  SD -0.1  9.1 p-value versus placebo * p≤0.05 versus placebo
Icelandic: Meðaltalsbreyting eftir 24 vikur  staðalfrávik p-gildi samanborið við lyfleysu * p≤ 0,05 samanborið við lyfleysu
English: The following adverse reactions have only been observed with rivastigmine capsules and oral solution and not in clinical studies with rivastigmine transdermal patches: somnolence, malaise, tremor, confusion, sweating increased (common); duodenal ulcers, angina pectoris (rare); gastrointestinal haemorrhage (very rare); and some cases of severe vomiting were associated with oesophageal rupture (not known).
Icelandic: Svefnhöfgi, lasleiki, skjálfti, ringlun, aukin svitamyndun (algengt); skeifugarnarsár, hjartaöng (mjög sjaldgæft); blæðing í meltingarvegi (koma örsjaldan fyrir); og nokkur tilfelli alvarlegra uppkasta leiddu til rofs í vélinda (tíðni ekki þekkt).
English: Transdermal use.
Icelandic: Þvagfærasýking.
English: In some other dermal toxicity studies, a mild irritant effect on the skin of laboratory animals, including controls, was observed.
Icelandic: á húð komu fram væg ertandi áhrif á húð hjá rannsóknardýrum, einnig hjá samanburðarhópi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 transdermal patch of 4.15 cm2 contains 7.17 mg rivastigmine and delivers 4.6 mg/24 h.
Icelandic: Hver 4,15 cm2 forðaplástur inniheldur rivastigmin 7,17 mg og losar 4,6 mg/24 klst.
English: p-value versus placebo *p<0.05 versus placebo
Icelandic: *p<0,05 samanborið við lyfleysu
English: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain
Icelandic: Kláði, roði, ofsakláði, blöðrumyndun, ofnæmishúðbólga, dreifð
English: Carefully remove the existing patch before putting on a new one.
Icelandic: Fjarlægðu varlega plásturinn sem er á húðinni áður en nýr er settur á.
English: Enestia
Icelandic: INNIHALDSLÝSING
English: Always use this medicine exactly as described in this leaflet and as your doctor has told you.
Icelandic: Alltaf skal nota Rivastigmine 3M Health Care Ltd. forðaplástra nákvæmlega eins og lýst er í þessum fylgiseðli eða eins og læknirinn hefur mælt fyrir um.
English: Tear the pouch open where indicated and remove the patch from the pouch.
Icelandic: Rífðu gat á pokann á ábentum stað, og fjarlægðu lyfjaplásturinn úr pokanum.
English: How to use Rivastigmine 3M Health Care Ltd.
Icelandic: Hvernig nota á Rivastigmine 3M Health Care Ltd.
English: Reapplication to the exact same skin location within 14 days should be avoided to minimise the potential risk of skin irritation.
Icelandic: Til að draga úr hættu á ertingu í húðinni skal forðast að setja plástur á nákvæmlega sama stað á húðinni og notaður hefur verið síðustu 14 sólarhringa.
English: - A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Icelandic: - Hjá sjúklingum sem nota 6 mg/sólarhring af rivastigmini til inntöku má skipta yfir í 4,6 mg/24 klst. forðaplástur.
English: - Hepatic impairment: Patients with clinically significant hepatic impairment might experience more adverse reactions (see sections 4.2 and 5.2).
Icelandic: Vera má að sjúklingar með klínískt marktækt skerta lifrarstarfsemi fái frekar aukaverkanir (sjá kafla 4.2 og 5.2).
English: • Patient reminder card
Icelandic: Minnisspjald fyrir sjúklinga
English: Rare (may affect up to 1 in 1,000 people) - Fits (seizures) - Ulcer in the intestine - Chest pain - this may be caused by heart spasm
Icelandic: Sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum) Hjartsláttartruflanir, t.d. hægur hjartsláttur
English: Initial dose Treatment is started with 4.6 mg/24 h.
Icelandic: Hefja skal meðferð með 4,6 mg/24 klst.
English: - A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
Icelandic: - Hjá sjúklingum sem nota 12 mg/sólarhring af rivastigmini til inntöku má skipta yfir í 9,5 mg/24 klst. forðaplástur.
English: Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Icelandic: Virkni ensímsins nær upphaflegu gildi u.þ.b. 9 klst. eftir að hámarkshömlun hefur náðst.
English: - Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Icelandic: Þrýstu plástrinum þétt að húðinni, í að minnsta kosti 30 sekúndur, með lófanum.
English: How to store Rivastigmine 3M Health Care Ltd.
Icelandic: Hvernig geyma á Rivastigmine 3M Health Care Ltd.
English: 7 transdermal patches 30 transdermal patches 60 transdermal patches 90 transdermal patches
Icelandic: 7 forðaplástrar 30 forðaplástrar 60 forðaplástrar 90 forðaplástrar
English: However, use of rivastigmine patch may lead to allergic contact dermatitis.
Icelandic: Hinsvegar getur notkun rivastigmin plásturs leitt til ofnæmissnertihúðbólgu.
English: Other adverse reactions
Icelandic: Neikvæður mismunur
English: Package Leaflet: Information for the user Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Icelandic: Rivastigmine 3M Health Care Ltd. 4,6 mg/24 klst. forðaplástur Rivastigmine 3M Health Care Ltd. 9,5 mg/24 klst. forðaplástur rivastigmin
English: Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:
Icelandic: Ef þú finnur fyrir einhverri af eftirtöldum aukaverkunum, sem geta reynst alvarlegar, skaltu fjarlægja plásturinn og láta lækninn tafarlaust vita:
English: LIST OF EXCIPIENTS Also contains polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Icelandic: Inniheldur einnig pólýester, etýl vínyl asetat, akrýlat blandfjölliðu lím og ísóprópýl mýrístat.
English: Total plasma clearance of rivastigmine was approximately 130 litres/h after a 0.2 mg intravenous dose and decreased to 70 litres/h after a 2.7 mg intravenous dose, which is consistent with the non-linear, over-proportional pharmacokinetics of rivastigmine due to saturation of its elimination.
Icelandic: Heildarplasmaúthreinsun rivastigmins var um 130 l/klst. eftir 0,2 mg skammt í bláæð og minnkaði í 70 l/klst.
English: Vascular disorders Not known Gastrointestinal disorders Common
Icelandic: Tíðni ekki þekkt Meltingarfæri Algengar
English: Placebo
Icelandic: Lyfleysa
English: Switching from capsules or oral solution to transdermal patches Based on comparable exposure between oral and transdermal rivastigmine (see section 5.2), patients treated with rivastigmine capsules or oral solution can be switched to Rivastigmine 3M Health Care Ltd. transdermal patches as follows: - A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
Icelandic: Ef skipt er úr meðferð með hylkjum eða mixtúru, lausn yfir í meðferð með forðaplástrum Þar sem útsetning er sambærileg eftir gjöf lyfjaforma rivastigmins til inntöku og til notkunar um húð (sjá kafla 5.2) má hjá sjúklingum í meðferð með rivastigmin hylkjum eða mixtúru, lausn, skipta yfir í meðferð með Rivastigmine 3M Health Care Ltd. forðaplástrum sem hér segir:
English: Hepatic impairment
Icelandic: Almenn vanlíðan
English: Marketing Authorisation Holder 3M Health Care Limited, 1 Morley Street,
Icelandic: Markaðsleyfishafi 3M Health Care Limited, 1 Morley Street, Loughborough, Leicestershire, LE11 1EP
English: IMPORTANT: - Take off the previous patch before putting ONE new patch on. - Only one patch per day.
Icelandic: Fjarlægja skal eldri plásturinn áður en NÝR plástur er settur á. Notaðu aðeins einn plástur á sólarhring.
English: Clinical studies in Alzheimer's dementia
Icelandic: Alzheimerssjúkdómi er að ræða.
English: Do not apply a new patch to the same skin area twice within 14 days.
Icelandic: Að minnsta kosti 14 dagar skulu líða milli þess sem nýr plástur er settur á sama húðsvæði.
English: BATCH NUMBER
Icelandic: Í töflu
English: ADCS-IADL scores: A positive difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
Icelandic: Jákvæður mismunur á DLSM bendir til meiri bætingar hjá þeim sem notuðu rivastigmin 13,3 mg/24 klst. samanborið við rivastigmin 9,5 mg/24 klst.
English: OTHER Apply one patch per day.
Icelandic: ANNAÐ Notið einn plástur á sólarhring.
English: Hallucinations, restlessness
Icelandic: - Breytingar á lifrarstarfsemi - Eirðarleysi
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Rivastigmine 3M Health Care Ltd.4,6 mg/24 h
English: Mean change at week 24  SD -0.6  6.4 p-value versus placebo
Icelandic: Meðaltalsbreyting eftir 24 vikur  staðalfrávik p-gildi samanborið við lyfleysu ADCS-CGIC
English: The patient's weight should be monitored during therapy with Rivastigmine 3M Health Care Ltd. transdermal patches.
Icelandic: Fylgjast skal með líkamsþyngd sjúklings meðan á meðferð með Rivastigmine 3M Health Care Ltd. forðaplástrum stendur.
English: 9.5 mg
Icelandic: 9,5 mg/24 klst.
English: - if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
Icelandic: ef þú ert með einkenni frá meltingarvegi svo sem ógleði, uppköst og niðurgang.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Rivastigmine 3M Health Care Ltd. 9,5 mg/24 h
English: Aggression
Icelandic: Eirðarleysi
English: No clinical data on exposed pregnancies are available.
Icelandic: Engin klínísk gögn liggja fyrir um notkun á meðgöngu.
English: Dehydration
Icelandic: Taugakerfi
English: Other medicines and Rivastigmine 3M Health Care Ltd.
Icelandic: Notkun annarra lyfja samhliða Rivastigmine 3M Health Care Ltd.
English: What Rivastigmine 3M Health Care Ltd. looks like and contents of the pack The transdermal patches are rectangular with rounded corners, approximately 2.5 cm by 1.8 cm (Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch) or 3.5 cm by 2.6 cm (Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch).
Icelandic: 4,6 mg/24 klst. forðaplástur) eða 3,5 cm sinnum 2,6 cm (Rivastigmine 3M Health Care Ltd. 9,5 mg/24 klst. forðaplástur).
English: Backing layer
Icelandic: HEITI LYFS
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and oral rivastigmine.
Icelandic: Þegar rivastigmin til inntöku og digoxin voru notuð samhliða, komu ekki fram nein óæskileg áhrif á leiðni í hjarta.
English: - Then press the patch firmly in place for at least 30 seconds using the palm of the hand to make sure that the edges stick well.
Icelandic: 30 sekúndur með því að nota lófann, til að tryggja að brúnir plástursins loði vel við húðina.
English: Pregnancy
Icelandic: Forðaplástrar
English: Anorexia, decreased appetite
Icelandic: Lystarleysi, minnkuð matarlyst.
English: As suggested by compartmental modelling, 9.5 mg/24 h transdermal patches exhibited exposure similar to that provided by an oral dose of 12 mg/day.
Icelandic: Í samræmi við hólfalíkan er útsetning eftir notkun rivastigmin 9,5 mg/24 klst. forðaplástra áþekk útsetningu eftir inntöku 12 mg/sólarhring.
English: If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g. decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24 h (see section 5.1).
Icelandic: hjá sjúklingum sem sýnt hafa marktæka aukningu á vitglöpum (þ.e. lækkun á MMSE) og/eða skerðingu á færni (samkvæmt mati læknis) meðan þeir voru á meðferð með ráðlögðum daglegum virkum skammti, sem er 9,5 mg/24 klst. (sjá kafla 5.1).
English: *A marketing authorisation for Rivastigmine 3M Health Care Ltd. 13.3 mg/24 h transdermal patch is currently not available, this presentation may although be available from other marketing authorisation holders.
Icelandic: * Markaðsleyfi fyrir Rivastigmine 3M Health Care Ltd. 13,3 mg/24 klst. plástra er ekki til staðar.
English: - if you have, or have ever had, an active stomach ulcer.
Icelandic: ef þú ert með eða hefur fengið virkt magasár.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Icelandic: Aukaverkanir taldar upp í töflu
English: ADCS-CGIC
Icelandic: VIRK(T) EFNI
English: Acrylate copolymer adhesive
Icelandic: - Akrýlat lím með blandfjölliðu
English: Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
Icelandic: Rivastigmine 3M Health Care Ltd.4,6 mg/24 klst. forðaplástur rivastigmin
English: Drug-in-adhesive (DIA) matrix
Icelandic: Tvíblind -vika 48
English: Renal impairment
Icelandic: forðaplástur rivastigmin
English: Oral studies in pregnant rats and rabbits gave no indication of teratogenic potential on the part of rivastigmine.
Icelandic: Rannsóknir á lyfinu, gefnu með inntöku, hjá rottum og kanínum á meðgöngu, bentu ekki til þess að rivastigmin hefði fósturskemmandi áhrif.
English: If you are pregnant, the benefits of using Rivastigmine 3M Health Care Ltd. transdermal patches must be assessed against the possible effects on your unborn child. Rivastigmine 3M Health Care Ltd. should not be used during pregnancy unless clearly necessary.
Icelandic: Konur sem nota Rivastigmine 3M Health Care Ltd. forðaplástra eiga ekki að hafa barn á brjósti.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Icelandic: Rivastigmine 3M Health Care Ltd. 9,5 mg/24 klst. forðaplástur rivastigmin
English: Return the used patch to its sachet and dispose of it in such a way that children cannot handle it. Do not touch your eyes with your fingers and wash your hands with soap and water after removing the patch.
Icelandic: Setjið notaðan plástur aftur í pokann og fargið á þann hátt að börn hvorki nái né sjái til.
English: Treatment should be temporarily interrupted if gastrointestinal adverse reactions are observed until these adverse reactions resolve.
Icelandic: Ef fram koma aukaverkanir á meltingarfæri skal tímabundið rjúfa meðferðina þar til aukaverkanirnar eru horfnar.
English: (nausea) or being sick (vomiting)
Icelandic: - Flog (krampar)
English: - Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patches: Each patch releases 9.5 mg of rivastigmine per 24 hours, is 8.3 cm2 and contains 14.33 mg of rivastigmine.
Icelandic: Hver plástur losar 9,5 mg af rivastigmini á 24 klst., er 8,3 cm2 og inniheldur 14,33 mg af rivastigmini.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours.
Icelandic: Hver forðaplástur losar 4,6 mg af rivastigmini á 24 klst.
English: No study was conducted with rivastigmine transdermal patches in subjects with hepatic impairment.
Icelandic: Rivastigmin forðaplástrar voru ekki rannsakaðir hjá sjúklingum með skerta lifrarstarfsemi.
English: EXPIRY DATE
Icelandic: LOCF Upphafs
English: Polyester
Icelandic: - Pólýester
English: - The other ingredients are polyester, ethyl vinyl acetate, acrylate copolymer adhesive and isopropyl myristate.
Icelandic: - Önnur innihaldsefni eru pólýester, etýl vínyl asetat, akrýlat blandfjölliðu lím og ísóprópýl mýristat.
English: Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Icelandic: Ef þú finnur fyrir einhverju af þessu, skaltu fjarlægja plásturinn og láta lækninn tafarlaust vita.
English: The results for clinically relevant responders from the 24-week placebo-controlled study are provided in Table 3.
Icelandic: 3 er að finna niðurstöður varðandi þá sem sýndu klíníska svörun við meðferð í 24 vikna samanburðarrannsókninni með lyfleysu.
English: - Renal impairment: No dose adjustment is necessary for patients with renal impairment.
Icelandic: Skert lifrarstarfsemi rivastigmin forðaplástrar voru ekki rannsakaðir hjá sjúklingum með skerta lifrarstarfsemi.
English: Isopropyl myristate
Icelandic: YTRI UMBÚÐUM ASKJA
English: Unchanged rivastigmine is found in trace amounts in the urine; renal excretion of the metabolites is the major route of elimination after transdermal patch administration.
Icelandic: Helsta brotthvarfsleiðin eftir notkun forðaplásturs, er útskilnaður umbrotsefna um nýru.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Icelandic: Aukaverkanir í töflu 1 eru flokkaðar samkvæmt
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch releases 9.5 mg of rivastigmine per 24 hours.
Icelandic: Hver forðaplástur losar 9,5 mg af rivastigmini á 24 klst.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Icelandic: 14. AFGREIÐSLUTILHÖGUN Lyfseðilsskylt lyf.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch
Icelandic: HEITI LYFS Rivastigmine 3M Health Care Ltd. 9,5 mg/24 klst. forðaplástur
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Icelandic: HEITI LYFS OG ÍKOMULEIÐIR Rivastigmine 3M Health Care Ltd. 9,5 mg/24 klst.
English: Mean baseline  SD
Icelandic: INNRI UMBÚÐUM LÍTILLA EININGA
English: - Treatment usually starts with Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h. - The recommended daily dose is Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h (this high strength is currently not available from 3M but may be available from other Marketing
Icelandic: Rivastigmine 13,3 mg/24 klst.* *Markaðsleyfi fyrir Rivastigmine 3M Health Care Ltd. 13,3 mg/24 klst. plástra er ekki til staðar.
English: Symptomatic treatment for other adverse reactions should be given as necessary.
Icelandic: Veita skal meðferð við öðrum aukaverkunum í samræmi við einkenni og eftir þörfum.
English: Fall
Icelandic: ADAS
English: What you need to know before you use Rivastigmine 3M Health Care Ltd.
Icelandic: Áður en byrjað er að nota Rivastigmine 3M Health Care Ltd.
English: Dose escalation
Icelandic: Stífir útlimir
English: Therefore, in patients with dementia treated with rivastigmine, the ability to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Icelandic: Því skal læknir sem annast meðferðina reglulega meta hæfni sjúklinga með vitglöp, sem nota rivastigmin, til áframhaldandi aksturs eða notkunar flókins tækjabúnaðar.