FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 lists the number and percentage of patients from the specific 24-week clinical study conducted with rivastigmine in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms.
Icelandic: Í töflu 3 kemur fram fjöldi og hlutfall sjúklinga sem sýndu fyrirfram skilgreindar aukaverkanir sem gætu endurspeglað versnun einkenna Parkinsonsveiki í klínísku rannsókninni sem gerð var á notkun rivastigmin hjá sjúklingum með vitglöp í tengslum við Parkinsonsveiki og stóð yfir í 24 vikur.
English: Frequency categories are defined using the following convention: very common
Icelandic: Tíðniflokkarnir eru skilgreindir á eftirfarandi hátt:
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Icelandic: Rivastigmin vinnur þannig að það hemlar ensímin sem brjóta niður acetýlkólín: acetýlkólínesterasa og bútýrýlkólínesterasa.
English: However, rivastigmine may be used in this patient population and close monitoring is necessary.
Icelandic: Hins vegar má nota rivastigmin hjá þessum sjúklingum ef haft er náið eftirlit með þeim.
English: Other medicines and Rivastigmine HEXAL
Icelandic: Notkun annarra lyfja samhliða Rivastigmine HEXAL
English: - The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide red iron oxide, titanium dioxide, and shellac.
Icelandic: gelatína, gult járnoxíð, rautt járnoxíð, títantvíoxíð og shellac.
English: However, due to increased exposure in these populations dosing recommendations to titrate according to individual tolerability should be closely followed as patients with clinically significant renal or hepatic impairment might experience more dose-dependent adverse reactions.
Icelandic: Hins vegar skal, vegna aukinnar útsetningar hjá þessum sjúklingum, fara nákvæmlega eftir ráðleggingum um skammtaaðlögun samkvæmt þoli einstaklings því vera má að sjúklingar með klínískt marktækt skerta nýrna- eða lifrarstarfsemi fái frekar skammtaháðar aukaverkanir.
English: Cardiac arrhythmia (e.g. bradycardia, atrioventricular block, atrial fibrillation and tachycardia)
Icelandic: Hjartsláttartruflanir (t.d. hægsláttur, A-V leiðslurof, gáttatif og hraðsláttarköst)
English: One of the excipients in Rivastigmine HEXAL oral solution is sodium benzoate.
Icelandic: Meðal hjálparefna í Rivastigmine HEXAL mixtúru, lausn er natríumbenzoat.
English: Cholinergic toxicity has been reported with muscarinic symptoms that are observed with moderate poisonings such as miosis, flushing, digestive disorders including abdominal pain, nausea, vomiting and diarrhoea, bradycardia, bronchospasm and increased bronchial secretions, hyperhidrosis, involuntary urination and/or defecation, lacrimation, hypotension and salivary hypersecretion.
Icelandic: Tilkynnt hefur verið um kólínergar eiturverkanir með múskarínvirkum einkennum sem koma fram við miðlungsmiklar eitranir, eins og ljósopsþrengingu, roða, meltingartruflanir þ.m.t. kviðverki, ógleði, uppköst og niðurgang, hægslátt, berkjukrampa og aukna berkjuseytingu, svitamyndun, ósjálfráð þvaglát og/eða hægðir, tárarennsli, lágþrýsting og aukna munnvatnsmyndun.
English: Each Rivastigmine HEXAL 1.5 mg capsule contains 1.5 mg of rivastigmine.
Icelandic: Hvert Rivastigmine HEXAL 1,5 mg hylki inniheldur 1,5 mg af rivastigmini.
English: Domaniewska 50 C PL - 02-672 Warszawa Phone: +48 22 549 15 00
Icelandic: Sandoz Polska Sp.z o.o. ul. Domaniewska 50 C PL - 02-672 Warszawa Phone:
English: - if you have, or have ever had, irregular or slow heartbeat.
Icelandic: - ef þú ert með eða hefur fengið hjartsláttaróreglu eða hægan hjartslátt.
English: Each Rivastigmine HEXAL 3 mg capsule contains 3 mg of rivastigmine.
Icelandic: Hvert Rivastigmine HEXAL 3 mg hylki inniheldur 3 mg af rivastigmini.
English: - if you have, or have ever had impaired liver function.
Icelandic: - ef þú ert með eða hefur verið með skerta lifrarstarfsemi.
English: - Capsule fill: - Microcrystaline cellulose - Magnesium stearate - Hypromellose - Silica, colloidal anhydrous
Icelandic: - Örkristallaður sellulósi - Magnesíumsterat - Hýprómellósi - Vatnsfrí kísilkvoða
English: Store in an upright position.
Icelandic: Geymið flöskuna í uppréttri stöðu.
English: Very common Common Not known
Icelandic: Mjög algengar Algengar Tíðni ekki þekkt
English: Each Rivastigmine HEXAL 4.5 mg capsule contains 4.5 mg of rivastigmine.
Icelandic: Hvert Rivastigmine HEXAL 4,5 mg hylki inniheldur 4,5 mg af rivastigmini.
English: • Dehydration (losing too much fluid)
Icelandic: Ofþornun (of mikið vökvatap)
English: - if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.
Icelandic: - ef áður hafa fram komið húðviðbrögð sem benda til ofnæmissnertihúðbólgu vegna rivastigmins.
English: (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
Icelandic: Mjög algengar (≥ 1/10); algengar (≥ 1/100, < 1/10); sjaldgæfar (≥ 1/1.000, < 1/100); mjög sjaldgæfar (≥ 1/10.000, < 1/1.000); koma örsjaldan fyrir (< 1/10.000) og tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Icelandic: Retrieved drop outs.
English: Hallucinations Aggression, restlessness
Icelandic: Árásargirni, eirðarleysi
English: D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Icelandic: D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS
English: Pharmacotherapeutic group: psychoanaleptics, anticholinesterases, ATC code: N06DA03 Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones.
Icelandic: Rivastigmin er acetýl- og bútýrýlkólínesterasahemill af carbamat gerð, sem er talinn auðvelda flutning kólínvirkra taugaboða með því að hægja á niðurbroti acetýlkólíns sem starfhæfar kólínvirkar taugafrumur gefa frá sér.
English: Patients with visual hallucinations
Icelandic: Sjúklingar með ofsjónir
English: • Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
Icelandic: Brisbólga - meðal einkenna eru miklir verkir í efri hluta kviðarhols, oft með ógleði og uppköstum
English: NL-1327 AH Almere Tel: +31 36 5241600 info.sandoz-nl@sandoz.com
Icelandic: +31 36 5241600 info.sandoz-nl@sandoz.com
English: Very rare Very rare Not known
Icelandic: Mjög sjaldgæfar Tíðni ekki þekkt
English: Table 2 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with rivastigmine capsules.
Icelandic: 2 eru tilgreindar aukaverkanir sem greint var frá í klínískum rannsóknum sem gerðar voru hjá sjúklingum með vitglöp í Parkinsonsveiki sem fengu meðferð með rivastigmin hylkjum .
English: • Fits (seizures)
Icelandic: Flog (krampar)
English: - Printing ink: - Shellac - Red iron oxide (E172)
Icelandic: - Shellac - Rautt járnoxíð (E172)
English: Very common Very common Common
Icelandic: Mjög algengar Mjög algengar
English: Rare (may affect up to 1 in 1,000 people)
Icelandic: Mjög sjaldgæfar (geta komið fyrir hjá allt að 1 af hverjum 1.000 einstaklingum)
English: Sandoz dd
Icelandic: Sandoz Pharmaceuticals DD
English: Rivastigmine may cause increased gastric acid secretions.
Icelandic: Notkun rivastigmin-plásturs getur þó leitt til ofnæmissnertihúðbólgu.
English: MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Icelandic: FRAMLEIÐENDUR SEM ERU ÁBYRGIR FYRIR LOKASAMÞYKKT
English: Therefore, caution should be exercised when rivastigmine is combined with beta-blockers and also other bradycardia agents (e.g.class III antiarrhythmic agents, calcium channel antagonists, digitalis glycoside, pilocarpin).
Icelandic: Þess vegna skal gæta varúðar þegar rivastigmin tengist betablokkum og einnig öðrum hægsláttarlyfjum (t.d. lyfja af flokki III við hjartsláttaróreglu, kalsíumganga-blokka, dígítalis glýkósíðs og pílókarpíns).
English: • Swallow the capsules whole with a drink.
Icelandic: Gleypið hylkin í heilu lagi með vökva.
English: Hepatic impairment
Icelandic: Óreglulegur hjartsláttur
English: Each ml contains rivastigmine hydrogen tartrate corresponding to rivastigmine base 2.0 mg. - The other ingredients are: sodium benzoate, citric acid, sodium citrate, quinoline yellow WS dye (E104) and purified water.
Icelandic: - Önnur innihaldsefni eru natríumbenzoat, sítrónusýra, natríumsítrat, kinolingulur WS litur (E104) og hreinsað vatn.
English: What Rivastigmine HEXAL looks like and contents of the pack
Icelandic: Útlit Rivastigmine HEXAL og pakkningastærðir
English: Metabolism and nutrition disorders
Icelandic: Kviðverkir og meltingartruflanir
English: Rivastigmine HEXAL 1.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Icelandic: Rivastigmine HEXAL 1,5 mg hörð hylki rivastigmin (sem hýdrógentartrat)
English: - Capsule shell: - Gelatin - Titanium dioxide (E171) - Yellow iron oxide (E172)
Icelandic: - Títantvíoxíð (E171) - Gult járnoxíð (E172)
English: There is no relevant use of Rivastigmine HEXAL in the paediatric population in the treatment of Alzheimer's disease.
Icelandic: Notkun Rivastigmine HEXAL á ekki við hjá börnum við meðferð við Alzheimerssjúkdómi.
English: Rivastigmine HEXAL 1.5 mg hard capsules:
Icelandic: Rivastigmine HEXAL 1,5 mg hörð hylki:
English: If you take more Rivastigmine HEXAL than you should
Icelandic: Ef stærri skammtur af Rivastigmine HEXAL en mælt er fyrir um er tekinn
English: Rivastigmine HEXAL 6 mg hard capsules rivastigmine (as hydrogen tartrate)
Icelandic: Rivastigmine HEXAL 6 mg hörð hylki rivastigmin (sem hýdrógentartrat)
English: Only for carton box: PC:
Icelandic: Einungis á öskjupakkningu:
English: Rivastigmine HEXAL 4.5 mg hard capsules rivastigmine (as hydrogen tartrate)
Icelandic: Rivastigmine HEXAL 4,5 mg hörð hylki rivastigmin (sem hýdrógentartrat)
English: Each capsule contains 6 mg of rivastigmine (as hydrogen tartrate).
Icelandic: Hvert hylki inniheldur 6 mg af rivastigmini (sem hýdrógentartrat).
English: Each ml contains 2.0 mg of rivastigmine (as hydrogen tartrate).
Icelandic: Hver ml inniheldur 2 mg af rivastigmini (sem hýdrógentartrat).
English: CARTON FOR HDPE BOTTLE LABEL FOR HDPE BOTTLE
Icelandic: ÁLETRUN FYRIR HDPE GLAS
English: How to store Rivastigmine Hexal
Icelandic: Hvernig geyma á Rivastigmine Hexal
English: HEXAL Pharma GmbH Stella-Klein-Löw-Weg 171020 Wien Tel: + 43 (0)1 486 96 22
Icelandic: HEXAL Pharma GmbH Stella-Klein-Löw-Weg 17 1020
English: Rivastigmine should be administered twice a day, with morning and evening meals.
Icelandic: Gefa á rivastigmin mixtúru tvisvar sinnum á dag, með morgunverði og kvöldverði.
English: Each capsule contains 4.5 mg of rivastigmine (as hydrogen tartrate).
Icelandic: Hvert hylki inniheldur 4,5 mg af rivastigmini (sem hýdrógentartrat).
English: Rivastigmine HEXAL 3 mg hard capsules rivastigmine (as hydrogen tartrate)
Icelandic: Rivastigmine HEXAL 3 mg hörð hylki rivastigmin (sem hýdrógentartrat)
English: - Rivastigmine HEXAL 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
Icelandic: - Rivastigmine HEXAL 4,5 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með rauðri hettu og rauðum bol, með hvítri áletrun „RIV 4,5 mg“ á bolnum.
English: Reporting of side effects
Icelandic: Tilkynning um grun um aukaverkanir
English: The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Icelandic: Að auki hefur verið greint frá eftirfarandi aukaverkunum við notkun á rivastigmin-forðaplástrum: óráði, hita, minnkaðri matarlyst, þvagleka (algengt), skynhreyfiofvirkni (sjaldgæft), hörundsroða, ofsakláða, blöðrum, ofnæmishúðbólgu (tíðni ekki þekkt).
English: - Rivastigmine HEXAL 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
Icelandic: - Rivastigmine HEXAL 1,5 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með gulri hettu og gulum bol, með rauðri áletrun „RIV 1,5 mg“ á bolnum.
English: • Changes in how well your liver is working
Icelandic: Breytingar á lifrarstarfsemi
English: CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Icelandic: FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS
English: How to take Rivastigmine HEXAL
Icelandic: Hvernig nota á Rivastigmine HEXAL
English: E-mail: info.sandoz-nl@sandoz.com
Icelandic: S E-mail: info.sandoz-dk@sandoz.com
English: Each capsule contains 3 mg of rivastigmine (as hydrogen tartrate).
Icelandic: Hvert hylki inniheldur 3 mg af rivastigmini (sem hýdrógentartrat).
English: Rivastigmine HEXAL 2 mg/ml oral solution
Icelandic: Rivastigmine HEXAL 2 mg/ml mixtúra, lausn
English: Each capsule contains 1.5 mg of rivastigmine (as hydrogen tartrate).
Icelandic: Hvert hylki inniheldur 1,5 mg af rivastigmini (sem hýdrógentartrat).
English: (n=158) n/a
Icelandic: (n=158)
English: - Rivastigmine HEXAL 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
Icelandic: - Rivastigmine HEXAL 6 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með rauðri hettu og appelsínugulum bol, með rauðri áletrun „RIV 6 mg“ á bolnum.
English: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “RIV 4.5 mg” on the body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með rauðri hettu og rauðum bol með hvítri áletrun „RIV 4,5 mg“ á bolnum.
English: Common Uncommon
Icelandic: Almenn vanlíðan
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4,5 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 4,5 mg af rivastigmini.
English: Rare Very rare
Icelandic: Sjaldgæfar Mjög sjaldgæfar Koma örsjaldan fyrir
English: - Capsule shell: - Gelatin - Titanium dioxide (E171) - Yellow iron oxide (E172) - Red iron oxide (E172)
Icelandic: - Gult járnoxíð (E172) - Rautt járnoxíð (E172)
English: Cogwheel rigidity Dystonia
Icelandic: Vélrænn stirðleiki í hreyfingum (cogwheel rigidity)
English: Quinoline yellow WS dye (E104) Purified water
Icelandic: - Natríumbenzoat - Sítrónusýra - Natríumsítrat - Kinolingulur WS litur (E104) - Hreinsað vatn
English: CONDITIONS OR RESTRICTION REGARDING SUPPLY AND USE
Icelandic: FORSENDUR FYRIR, EÐA TAKMARKANIR Á, AFGREIÐSLU OG NOTKUN
English: - Rivastigmine HEXAL 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
Icelandic: - Rivastigmine HEXAL 3 mg hörð hylki, sem innihalda beinhvítt til ljósgulleitt þurrefni, eru með appelsínugulri hettu og appelsínugulum bol, með rauðri áletrun „RIV 3 mg“ á bolnum.
English: Rivastigmine HEXAL 2 mg/ml oral solution rivastigmine (as hydrogen tartrate)
Icelandic: Rivastigmine HEXAL 2 mg/ml mixtúra, lausn rivastigmin (sem hýdrógentartrat)
English: In pregnant animals, rivastigmine and/or metabolites crossed the placenta.
Icelandic: Rivastigmin og/eða umbrotsefni fóru yfir fylgju hjá dýrum á meðgöngu.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1,5mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 1,5 mg af rivastigmini.
English: If you are pregnant, the benefits of using Rivastigmine HEXAL must be assessed against the possible effects on your unborn child. Rivastigmine HEXAL should not be used during pregnancy unless clearly necessary
Icelandic: Ef þú ert þunguð verður að meta ávinninginn af notkun Rivastigmine HEXAL með tilliti til hugsanlegra áhrifa á ófætt barn þitt.
English: blisters.
Icelandic: PDS.
English: Common Common Common Uncommon Uncommon Very rare Not known
Icelandic: Algengar Sjaldgæfar Sjaldgæfar Tíðni ekki þekkt
English: Very common Very common Very common Common Rare
Icelandic: Mjög algengar Mjög algengar Mjög algengar Algengar
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 6 mg af rivastigmini.
English: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “RIV 1.5 mg” on the body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með gulri hettu og gulum bol, með rauðri áletrun „RIV 1,5 mg“ á bolnum.
English: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “RIV 6 mg” on the body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með rauðri hettu og appelsínugulum bol með rauðri áletrun „RIV 6 mg“ á bolnum.
English: Hyperhydrosis
Icelandic: MEÐ BLINDRALETRI
English: Renal impairment
Icelandic: Mikil ringlun
English: Only for carton box: 2D barcode carrying the unique identifier included.
Icelandic: Á pakkningunni er tvívítt strikamerki með einkvæmu auðkenni.
English: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine.
Icelandic: Hvert hylki inniheldur rivastigminhýdrógentartrat sem jafngildir 3 mg af rivastigmini.
English: Management
Icelandic: Road
English: (n=289) n/a
Icelandic: (n=289)
English: PSURs
Icelandic: Krampar
English: Type III amber glass bottle with a child-resistant cap, dip tube and self aligning plug.
Icelandic: Gulbrún flaska úr gleri af gerð III, með barnaöryggislokun og millistykki sem munnskammtasprautan er sett í. 50 ml eða 120 ml flöskur.
English: • Too much saliva and dehydration
Icelandic: Of mikil munnvatnsmyndun og ofþornun
English: • Trembling or feeling confused
Icelandic: Skjálfti eða rugl
English: • Take the syringe out of its protective case.
Icelandic: Takið sprautuna úr hulstrinu.
English: • The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles,
Icelandic: Parkisonsveiki versna eða svipuð einkenni koma fram - svo sem vöðvastirðleiki og erfiðleikar við hreyfingu.
English: very rare (<1/10,000); not known (cannot be estimated from the available data).
Icelandic: sjaldgæfar (≥ 1/1.000, < 1/100); mjög sjaldgæfar (≥ 1/10.000, < 1/1.000); koma örsjaldan fyrir (< 1/10.000) og tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: Each ml contains rivastigmine hydrogen tartrate corresponding to 2g rivastigmine.
Icelandic: Hver ml inniheldur rivastigminhýdrógentartrat sem jafngildir 2 mg af rivastigmini.
English: Sliema Road
Icelandic: Parkinsonsgöngulag
English: Only for carton box: Rivastigmine HEXAL 2 mg/ml
Icelandic: Rivastigmine HEXAL 2 mg/ml
English: Somnolence
Icelandic: Sviti
English: • The highest dose that should be taken is 6.0 mg twice a day.
Icelandic: Stærsti skammtur sem má nota er 6 mg tvisvar sinnum á sólarhring.
English: Medicinal product on “restricted” medical prescription, reserved for use in certain specialised area (See Annex I: Summary of Product Characteristics, Section 4.2).
Icelandic: Lyf sem eingöngu má nota eftir ávísun tiltekinna sérfræðilækna, eingöngu til nota á tilteknu sérsvið (Sjá viðauka I:
English: difficulty in carrying out movements and muscle weakness
Icelandic: Óreglulegur hjartsláttur og erfiðleikar með að stjórna hreyfingum
English: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “RIV 3 mg” on the body.
Icelandic: Beinhvítt eða ljósgulleitt þurrefni í hylki með appelsínugulri hettu og appelsínugulum bol með rauðri áletrun „RIV 3 mg“ á bolnum.
English: If you accidentally take more Rivastigmine HEXAL than you should, inform your doctor.
Icelandic: Segðu lækninum ef þú hefur af slysni notað meira af Rivastigmine HEXAL en þú áttir að gera.
English: • Urinary incontinence (inability to retain adequate urine)
Icelandic: Þvagleki (erfiðleikar við að halda aftur af þvagi)
English: (n=165) n/a
Icelandic: (n=165)
English: There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
Icelandic: Börn Notkun rivastigmins á ekki við hjá börnum við meðferð við Alzheimerssjúkdómi.
English: Muscle rigidity
Icelandic: Algengar Algengar
English: - This medicine has been prescribed for you only .
Icelandic: - Þessu lyfi hefur verið ávísað til persónulegra nota.
English: - Capsule fill: - Microcrystaline cellulose
Icelandic: - Magnesíumsterat - Hýprómellósa
English: Parkinson's disease (worsening) Bradykinesia
Icelandic: Parkinsonsveiki (versnandi) Hæghreyfingar
English: Vomiting
Icelandic: Ofskynjanir
English: Fertility
Icelandic: Gildi
English: Common Uncommon Uncommon Not known
Icelandic: Koma örsjaldan fyrir Tíðni ekki þekkt
English: Rivastigmine HEXAL 4.5 mg hard capsules:
Icelandic: Rivastigmine HEXAL 4,5 mg hörð hylki
English: Gait abnormality
Icelandic: Mjög algengar Algengar
English: Table 1 Infections and infestations
Icelandic: Tafla 1 Sýkingar af völdum sýkla og sníkjudýra
English: What is Kaletra and what is it used for?
Icelandic: UM KALETRA OG VIÐ HVERJU ÞAÐ ER NOTAÐ
English: EMA/476880/2017 EMEA/H/C/000368
Icelandic: EU/1/01/172/008/IS
English: The capsules and liquid must be taken with food, but the tablets can be taken with or without food.
Icelandic: Kaletra töflur má taka með eða án matar.
English: The full EPAR for Kaletra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Icelandic: Lyfjastofnunar Evrópu http://www.ema.europa.eu/
English: Kaletra lopinavir / ritonavir
Icelandic: Æxlunarfæri og brjóst
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Icelandic: Aesica Queenborough Ltd, Queenborough, Kent ME11 5EL, Bretland
English: Kaletra can only be obtained with a prescription and should be prescribed by a doctor with experience treating HIV infection.
Icelandic: Ávísun Kaletra ætti að vera bundin við lækna með reynslu af meðferð við HIV sýkingum.
English: The most common side effects with Kaletra in adults (seen in more than 1 patient in 10) are upper respiratory tract infection (colds), nausea (feeling sick) and diarrhoea.
Icelandic: MJÖG ALGENGAR aukaverkanir (koma fyrir hjá fleiri en 1 notanda af 10) - Niðurgangur; - Ógleði; - Sýking í efri öndunarvegi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kaletra on 20 March 2001.
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis: 20. mars 2001.
English: How is Kaletra used?
Icelandic: Hvernig á að taka Kaletra?
English: This is a summary of the European public assessment report (EPAR) for Kaletra.
Icelandic: Abbott Laboratories (Magyarország) Kft.
English: It is not intended to provide practical advice on how to use Kaletra.
Icelandic: Ekki er ráðlagt að nota rifampicin samhliða Kaletra.
English: When the enzyme is blocked, the virus does not reproduce normally slowing down its multiplication in the body.
Icelandic: Það gerir Kaletra með því að hægja á útbreiðslu sýkingarinnar í líkamanum.
English: Kaletra is an HIV medicine used in combination with other medicines to treat adults and children from over 14 days of age who are infected with HIV-1.
Icelandic: Kaletra er ráðlagt til notkunar fyrir fullorðna og börn 2 ára og eldri sem eru sýkt með HIV.
English: Kaletra is effective at reducing HIV viral loads to below 400 copies/ml in the majority of adults and children from 14 days of age.
Icelandic: HIV RNA < 400 eintök/ml Aukning að meðaltali frá upphafsgildi á CD4+ T-frumu fjölda (frumur/mm3)
English: Kaletra contains two active substances, lopinavir and ritonavir.
Icelandic: Virku innihaldsefnin eru lopinavir og ritonavir.
English: Other information about Kaletra
Icelandic: Ef vegna Kaletra