FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking Rasagiline ratiopharm and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Icelandic: Rasagiline ratiopharm og/eða önnur lyf við Parkinsonssjúkdómi hefur atferli eins og árátta, þráhyggjuhugsanir, spilafíkn, óhófleg eyðsla, hvatvísi og óeðlilega mikil kynhvöt eða auknar kynlífshugsanir eða -tilfinningar.
English: In mice, increased incidences of combined bronchiolar/alveolar adenoma and/or carcinoma were observed at systemic exposures, 144 - 213 times the expected plasma exposure in humans at 1 mg/day.
Icelandic: Hjá músum sást fjölgun tilvika bæði berkju/blöðru kirtilæxla og eða krabbameins þegar styrkur í plasma var 144 - 213 sinnum hærri en sá styrkur lyfs í plasma sem búast má við hjá mönnum við skammtastærð 1 mg/dag.
English: Non-clinical data indicate that rasagiline inhibits prolactin secretion and thus, may inhibit lactation.
Icelandic: Forklínískar upplýsingar sýna að rasagílín hamlar seytingu prólaktíns og getur því hamlað mjólkurmyndun.
English: As a precautionary measure, it is preferable to avoid the use of rasagiline during pregnancy.
Icelandic: Til öryggis ætti að forðast notkun rasagílíns á meðgöngu.
English: The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p<0.0001) to that observed in the rasagiline 1 mg group.
Icelandic: “OFF” stunda á sólarhring var svipuð í entacapón hópnum (-0,80 klst., 95% CI [-1,20; -0,41], p<0,0001) og í hópnum sem fékk 1 mg af rasagílíni.
English: In the post-marketing period, cases of potentially life-threating serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants, meperidine, tramadol, methadone, or propoxyphene concomitantly with rasagiline.
Icelandic: Eftir markaðssetningu hefur verið skýrt frá hugsanlega lífshættulegum tilvikum serótónín heilkennis með æsingi, ringlun, stífni, hita og vöðvakippum, hjá sjúklingum sem fá meðferð með þunglyndislyfjum, meperidíni, tramadóli, metadóni eða própoxýfeni samhliða rasagílíni.
English: Skin melanoma*
Icelandic: Sortuæxli í húð*
English: In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4 and 5.2).
Icelandic: Ef væg skerðing á lifrarstarfsemi þróast í miðlungsmikla skerðingu á lifrarstarfsemi skal hætta meðferð með rasagílíni (sjá kafla 4.4 og 5.2).
English: Levodopa and other Parkinson's disease medicinal products In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Icelandic: Hjá sjúklingum með Parkinsonssjúkdóm sem fengu rasagílín ásamt langvarandi meðferð með levódópa voru engin klínískt marktæk áhrif af levódópa meðferð á úthreinsun rasagílíns.
English: CYP1A2 inhibitors
Icelandic: CYP1A2 hemlar
English: In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
Icelandic: III var meðalmunurinn í samanburði við lyfleysu -0,94 klst., 95% CI [-1,36; -0,51], p<0,0001.
English: Aluminium/aluminium perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets.
Icelandic: Ál/ál rifgataðar stakskammtaþynnur með 10 x 1, 30 x 1 eða 100 x 1 töflu.
English: You may need urgent medical advice or treatment: - If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
Icelandic: - Ef óvenjuleg hegðun kemur fram á borð við áráttu, þráhyggjuhugsanir, spilafíkn, óhóflega eyðslu eða kaupsýki, hvatvísi og óeðlilega mikla kynhvöt eða auknar kynferðislegar hugsanir (hvataraskanir) (sjá kafla 2).
English: In vitro experiments indicate that both routes of rasagiline metabolism are dependent on cytochrome P450 system, with CYP1A2 being the major iso-enzyme involved in rasagiline metabolism.
Icelandic: In vitro tilraunir sýna að báðar leiðirnar sem rasagílín umbrotnar eftir eru háðar cýtókróm P450 kerfinu, en rasagílín umbrotnar aðallega fyrir tilstilli
English: The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended (see section 4.5).
Icelandic: Samhliða notkun rasagílíns og dextrómetorphans eða adrenvirkra lyfja, þ.m.t. í nefdropum og lyfjum til inntöku við nefstíflu eða lyfja við kvefi sem innihalda efedrín eða pseudoephedrín, er ekki ráðlögð (sjá kafla 4.5).
English: Concomitant use of rasagiline with other medicinal products
Icelandic: Samhliða notkun rasagílíns og annarra lyfja
English: There is no relevant use of Rasagiline ratiopharm in the paediatric population in the indication Parkinson's disease.
Icelandic: Notkun Rasagiline ratiopharm á ekki við hjá börnum við ábendingunni Parkinsonssjúkdómi.
English: Fever, Malaise
Icelandic: - Ógleði og uppköst
English: The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies in patients receiving 1 mg/day rasagiline.
Icelandic: Eftirfarandi tafla tekur til aukaverkana sem skráðar voru af hærri tíðni í samanburðarrannsóknum með lyfleysu hjá sjúklingum sem fengu 1 mg/dag af rasagílíni.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets 10 x 1 tablets 30 x 1 tablets 100 x 1 tablets
Icelandic: 30 x 1 töflur 100 x 1 töflur
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l. Plasma protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%.
Icelandic: Próteinbinding í blóði eftir einn skammt til inntöku af 14C-merktu rasagílíni er u.þ.b. 60 til 70%.
English: In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 5.2).
Icelandic: Ef væg skerðing á lifrarstarfsemi þróast í miðlungsmikla skerðingu á lifrarstarfsemi skal hætta meðferð með rasagílíni (sjá kafla 5.2).
English: - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Icelandic: - Hiti - Flensa (inflúensa) - Almenn vanlíðan (lasleiki)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Icelandic: NAFN MARKAÐSLEYFISHAFA Teva B.V.
English: The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies, in patients receiving 1 mg/day rasagiline.
Icelandic: Eftirfarandi upptalning í formi töflu tekur til skráðra aukaverkana sem höfðu hærri tíðni í samanburðarrannsóknum með lyfleysu, hjá sjúklingum sem fengu 1 mg/dag af rasagílíni.
English: - Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome) - If you notice any suspicious skin changes because there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section 2).
Icelandic: - Ef vart verður við grunsamlegar breytingar á húð þar sem aukin hætta er á húðkrabbameini (ekki eingöngu sortuæxli) hjá sjúklingum með Parkinsonssjúkdóm (sjá kafla 2).
English: Additional cases of malignant melanoma were reported during post-marketing period.
Icelandic: Tilkynnt var um fleiri tilvik sortuæxla eftir markaðssetningu.
English: NAME OF THE MEDICINAL PRODUCT Rasagiline ratiopharm 1 mg tablets
Icelandic: Rasagiline ratiopharm 1 mg töflur
English: Musculoskeletal pain,
Icelandic: Hreyfitruflun Truflun á vöðvaspennu, Heilkenni úlnliðsganga,
English: Pethidine
Icelandic: Stearinsýra
English: - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Icelandic: - Þunglyndi - Svimi - Langvarandi vöðvasamdráttur (trufluð vöðvaspenna) - Nefrennsli (bólga í nefslímhúð) - Húðerting (húðbólga) - Útbrot, - Blóðhlaupin augu (tárubólga) - Þvaglátsþörf
English: A similar pattern of excessive daily sleepiness has been reported post-marketing with rasagiline.
Icelandic: Greint hefur verið frá svipuðum tilvikum mikillar dagsyfju við notkun rasagilíns eftir markaðssetningu.
English: In the presence of metabolite activation rasagiline induced an increase of chromosomal aberrations at concentrations with excessive cytotoxicity which are unattainable at the clinical conditions of use.
Icelandic: Þegar umbrot frumnanna voru örvuð, olli rasagílín auknum litningaskemmdum við lyfjastyrk sem ómögulegt er að ná með þeim klínísku skömmtum sem notaðir eru.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM ASKJA FYRIR GLÖS
English: If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline ratiopharm do not drive or operate machinery (see section 2).
Icelandic: Ef þú hefur fundið fyrir svefnhöfga og/eða skyndilegum svefni, áður eða meðan á töku
English: *See section description of selected adverse reactions
Icelandic: *Sjá kaflann um lýsingu á völdum aukaverkunum
English: Cerebrovascular accident
Icelandic: Áköf þvaglátaþörf
English: There have been reports of hypotensive effects when rasagiline is taken concomitantly with levodopa.
Icelandic: Tilkynnt hefur verið um blóðþrýstingslækkandi áhrif þegar rasagílín er tekið samhliða levódópa.
English: These adverse reactions were not associated with an elevated rate of drug discontinuation.
Icelandic: Aukaverkanirnar urðu ekki til þess að auka hlutfall þeirra sem hættu meðferðinni.
English: Talk to your doctor before taking Rasagiline ratiopharm - If you have any liver problems - You should speak with your doctor about any suspicious skin changes.
Icelandic: Leitið ráða hjá lækninum áður en Rasagiline ratiopharm er notað - Ef þú ert með lifrarkvilla
English: Parkinson's disease is associated with symptoms of hallucinations and confusion.
Icelandic: Einkenni ofskynjana og ringlun tengjast Parkinsonssjúkdómi.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain as back and neck pain, and arthralgia in both regimens.
Icelandic: Við einlyfjameðferð: höfuðverkur, þunglyndi, svimi og flensa (inflúensa og nefslímubólga); Við viðbótarmeðferð við levódópa: hreyfitruflun, stöðubundinn lágþrýstingur, byltur, kviðverkur, ógleði og uppköst, og munnþurrkur; Við báðar meðferðaráætlanir: stoðkerfisverkir, svo sem verkir í baki og hálsi, og liðverkir.
English: One case of hypersexuality was reported in monotherapy placebo-controlled study.
Icelandic: Tilkynnt var um eitt tilvik kynferðislegrar ofvirkni við rannsókn á einlyfjameðferð með samanburði við lyfleysu.
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes
Icelandic: Mikil dagsyfja og skyndileg svefnköst
English: How to take Rasagiline ratiopharm
Icelandic: Hvernig nota á Rasagiline ratiopharm
English: How to store Rasagiline ratiopharm
Icelandic: Hvernig geyma á Rasagiline ratiopharm
English: Do not take the following medicines while taking Rasagiline ratiopharm: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease, or used for any other indication), including medicinal and natural products without prescription e.g.
Icelandic: - Mónóamínoxídasahemla (MAO-hemla) (t.d. við þunglyndi eða Parkinsonssjúkdómi eða við hvaða sjúkdómi sem er) þ.m.t. lyf og náttúrulyf sem fengin eru án lyfseðils t.d.
English: Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3).
Icelandic: Ekki má nota rasagílín hjá sjúklingum með verulega skerðingu á lifrarstarfsemi (sjá kafla 4.3).
English: There are no data from the use of rasagiline in pregnant women.
Icelandic: Engar upplýsingar liggja fyrir um notkun rasagílíns á meðgöngu.
English: - Involuntary movements (dyskinesia) - Headache
Icelandic: - Verkir í liðamótum (liðverkir)
English: The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3).
Icelandic: Rasagílín skal ekki nota samhliða petidíni (sjá kafla 4.3).
English: In blinded placebo-controlled studies, severe orthostatic hypotension was reported in one subject (0.3%) in the rasagiline arm (adjunct studies), none in the placebo arm. Clinical trial data further suggest that orthostatic hypotension occurs most frequently in the first two months of rasagiline treatment and tends to decrease over time.
Icelandic: Í blinduðum rannsóknum með samanburði við lyfleysu var tilkynnt um alvarlegan stöðubundinn lágþrýsting hjá einum einstaklingi (0,3%) í rasagílín arminum (viðbótarmeðferð), en engum í lyfleysuarminum.
English: Impulse control disorders (ICDs)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Tablet 30 tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: Neoplasms benign, malignant and unspecified
Icelandic: Æxli, góðkynja og illkynja
English: INFORMATION IN BRAILLE Rasagiline ratiopharm
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Rasagiline ratiopharm
English: Flatulence
Icelandic: Tafla
English: Impulse control disorders
Icelandic: Stöðubundinn lágþrýstingur
English: 4.5 Interaction with other medicinal products and other forms of interaction MAO Inhibitors
Icelandic: 4.5 Milliverkanir við önnur lyf og aðrar milliverkanir
English: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG, Belgium Tel/Tél: +32 3 820 73 73
Icelandic: N.V./S.A./AG, Belgium
English: Orthostatic hypotension
Icelandic: Forhleypt maíssterkja
English: Hallucinations*, Abnormal dreams
Icelandic: Óeðlilegar draumfarir
English: Mannitol
Icelandic: Ringlun
English: Especially tell your doctor if you are taking any of the following medicines: - Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) - The antibiotic ciprofloxacin used against infections - The cough suppressant dextromethorphan - Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Icelandic: - Hóstastillandi lyfið dextrómethorphan - Adrenvirk lyf þ.m.t. augndropar, lyf við nefstíflu bæði til notkunar í nef og til inntöku og lyf gegn kvefi sem innihalda efedrín eða pseudoefedrín.
English: Ear and labyrinth disorders
Icelandic: Samhliða notkun rasagílíns og levódópa
English: - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Icelandic: - Uppþemba - Óeðlilegar niðurstöður úr blóðprufum (hvítkornafæð)
English: Myocardial infarction
Icelandic: Adrenvirk lyf
English: Leucopenia
Icelandic: Glös
English: The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
Icelandic: SNRI lyf/SSRI lyf/þríhringlaga og fjórhringlaga geðdeyfðarlyf Samhliða notkun rasagílíns og flúoxetíns eða flúvoxamíns ætti að forðast (sjá kafla 4.4).
English: What you need to know before you take Rasagiline ratiopharm
Icelandic: Áður en byrjað er að nota Rasagiline ratiopharm
English: Adopted at the 3-6 April 2017 PRAC
Icelandic: Samþykkt á fundi PRAC 3.-6 apríl 2017
English: It is important to avoid dehydration by drinking plenty of fluids.
Icelandic: Mikilvægt er að forðast vökvaskort með því að drekka nóg af vökva.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 April 2017
Icelandic: 30 Churchill Place ● Canary Wharf ● London E14 5EU ●
English: Package leaflet 4 - Possible side effects Other side effects:
Icelandic: 4 - Hugsanlegar aukaverkanir Aðrar aukaverkanir:
English: Dehydration
Icelandic: Vökvaskortur
English: 4.8 - Undesirable effects
Icelandic: 4.8 - Aukaverkanir
English: 4.4 - Special warning and precautions for use
Icelandic: 4.4 - Sérstök varnaðarorð og varúðarreglur við notkun
English: Leflunomide; teriflunomide - Falsely decreased ionised calcium levels (EPITT no 18787)
Icelandic: - Falskt lækkað gildi kalsíumjóna (EPITT nr. 18787)
English: When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, diarrhoea or dehydration.
Icelandic: Vökvaskortur gæti komið fram í upphafi meðferðar með albiglútíði vegna uppkasta, niðurgangs eða vökvataps.
English: Dehydration, sometimes leading to renal impairment and acute renal failure, has been reported in patients treated with albiglutide and has occurred in patients without gastrointestinal side effects.
Icelandic: Tilkynnt hefur verið um vökvaskort, sem í sumum tilfellum getur leitt til nýrnaskemmda og bráðrar nýrnabilunar, hjá sjúklingum sem fá albiglútíð og hefur komið fyrir hjá sjúklingum án aukaverkana frá meltingarfærum.
English: Talk to your doctor before taking {Drug Name} - if you are due to have a specific blood test (calcium level).
Icelandic: - ef þú átt að fara í blóðprufu (kalsíumgildi mæld).
English: Albiglutide - Acute kidney injury (EPITT no 18778)
Icelandic: - Bráð nýrnaskemmd (EPITT nr. 18778)
English: Patients treated with albiglutide should be advised of the potential risk of dehydration, and take precautions to avoid fluid depletion.
Icelandic: Sjúklingar sem fá albiglútíð skulu varaðir við hugsanlegri hættu á skorti á vökva og þeim ráðlagt að drekka ríkulega til að fyrirbyggja vökvaskort.
English: Meningoencephalitis herpetic
Icelandic: Leflúnómíð; teriflúnómíð
English: Frequency ‘uncommon': Meningoencephalitis herpetic (including cases with fatal outcome)
Icelandic: Tíðni ‘Sjaldgæfar': heilahimnu- og heilabólga af völdum herpesveiru (þ.m.t. banvæn tilvik)
English: 2 - What you need to know before you use Eperzan Warnings and precautions
Icelandic: - Áður en byrjað er að nota Eperzan
English: In post marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Icelandic: Tilkynnt hefur verið um heilahimnu- og heilabólgu af völdum herpesveiru (þ.m.t. banvæn tilvik) hjá sjúklingum sem fengu TMZ ásamt geislameðferð, þ.m.t. tilvik með samhliðagjöf stera.
English: Infections and infestations
Icelandic: Nýr texti fyrir lyfjaupplýsingar
English: Your doctor will test for these changes.
Icelandic: Læknirinn mun prófa fyrir þessum breytingum.
English: Your doctor will explain these to you.
Icelandic: Læknirinn mun útskýra þetta fyrir þér.
English: You must take Symtuza every day and always with food.
Icelandic: Þú verður að taka Symtuza daglega og alltaf með mat.
English: 6/L (see section 5.1).
Icelandic: 6/l (sjá kafla 5.1).
English: Age < 50 years ≥ 50 years
Icelandic: Aldur < 50 ára ≥ 50 ára
English: Your doctor will consider if Symtuza is the right medicine for you.
Icelandic: Læknirinn mun meta hvort Symtuza sé rétta lyfið fyrir þig.
English: Then take the next dose at your usual time.
Icelandic: Taktu síðan næsta skammt á venjulegum tíma.
English: Two-sided Exact Clopper-Pearson 95% CI
Icelandic: Tvíhliða Exact Clopper-Pearson 95% CI
English: Even when you feel better, do not stop taking Symtuza.
Icelandic: Jafnvel þótt þér líði betur skaltu ekki hætta að nota Symtuza.
English: Each bottle contains 30 tablets.
Icelandic: Hvert glas inniheldur 30 töflur.
English: EU/1/17/1225/001- 30 film-coated tablets EU/1/17/1225/002- 90 film-coated tablets (3 x 30)
Icelandic: EU/1/17/1225/001 - 30 filmuhúðaðar töflur EU/1/17/1225/002 - 90 filmuhúðaðar töflur (3 x 30)
English: You must eat a meal or a snack within 30 minutes before taking your Symtuza.
Icelandic: Þú verður að fá þér mat eða snarl minnst 30 mínútum áður en þú tekur Symtuza.
English: Take Symtuza at around the same time each day.
Icelandic: Taktu Symtuza um það bil á sama tíma dag hvern.
English: Keep the tablet bottle with you so that you can show what you have taken.
Icelandic: Hafðu töfluglasið meðferðis svo þú getir sýnt hvað þú tókst.
English: EXP Do not use after 6 weeks of first opening the bottle.
Icelandic: EXP Notið ekki 6 vikum eftir að glasið er fyrst opnað.
English: Primary PI/DRV
Icelandic: Frumkomnar PI/DRV
English: Ask your doctor if you are unsure about the severity of your liver disease.
Icelandic: Spurðu lækninn ef þú ert ekki viss um hversu alvarlegan lifrarsjúkdóm þú ert með.
English: These events are often transitory.
Icelandic: Þessar aukaverkanir eru oft skammvinnar.
English: - Ethinylestradiol/drospirenone.
Icelandic: Etinylestradiol/drospirenon.
English: Do not use this medicine after 6 weeks of first opening the bottle.
Icelandic: Ekki skal nota lyfið 6 vikum eftir að glasið er fyrst opnað.
English: Symtuza tablets should be taken with food.
Icelandic: Symtuza töflur á að taka með mat.
English: Discontinued trial due to adverse event or death
Icelandic: Hætt í rannsókn vegna aukaverkunar eða dauða
English: This difference is not clinically relevant.
Icelandic: Munurinn hefur ekki klíníska þýðingu.
English: If you belong to this age group, please discuss with your doctor if you can use Symtuza.
Icelandic: Ef þú tilheyrir þessum aldurshópi skaltu ræða við lækninn um hvort þú getir notað Symtuza.
English: The clinical relevance of this increase is unknown.
Icelandic: Klínískt mikilvægi þessarar hækkunar er ekki þekkt.
English: The tablet can be taken with a drink such as water, milk or any nutritional drink.
Icelandic: Töfluna má taka með vökva, t.d. vatni, mjólk eða næringardrykk.
English: When co-administration is required, the daily dose of itraconazole should not exceed 200 mg.
Icelandic: Þegar þörf er á samhliða meðferð, á sólarhringsskammtur itraconazols ekki að fara yfir 200 mg.
English: Based on MH test adjusting for bPI at screening (ATV with rtv or COBI, DRV with rtv or COBI, LPV with rtv)
Icelandic: Byggt á MH prófi aðlöguðu að bPI við skimun (ATV með rtv eða COBI, DRV með rtv eða COBI, LPV með rtv)
English: What Symtuza is and what it is used for
Icelandic: Upplýsingar um Symtuza og við hverju það er notað
English: Tell your doctor immediately, if any of these apply to you.
Icelandic: Segðu lækninum tafarlaust frá því ef eitthvað af þessu á við um þig.
English: It is important to talk to your doctor if you develop a rash.
Icelandic: Það er mikilvægt að tala við lækninn ef þú færð útbrot.
English: Darunavir and cobicistat
Icelandic: Darunavir og cobicistat
English: Discuss with your physician the precautions needed to avoid infecting other people.
Icelandic: Ræddu við lækninn um varúðarráðstafanir til að forðast að smita annað fólk.
English: They either switched to Symtuza (N = 763) or continued their treatment regimen (N = 378) (randomised 2:1).
Icelandic: Þeir skiptu annaðhvort yfir á Symtuza (N = 763) eða héldu áfram á meðferðaráætlun sinni (N = 378) (slembiraðað 2:1).
English: Anti-HIV medicines may make you feel better.
Icelandic: Lyf við HIV sýkingu geta bætt líðan þína.
English: Date of first authorisation: 21 September 2017
Icelandic: 21. september 2017
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example Monday-Wednesday-Friday).
Icelandic: Ef þörf er á samhliða notkun er ráðlagður skammtur 150 mg 3 sinnum í viku ákveðna daga (t.d. mánudag, miðvikudag, föstudag).
English: 3 years After first opening: 6 weeks
Icelandic: 3 ár. Eftir að pakkning hefur verið rofin: 6 vikur.
English: Skin rash may affect more than 1 in 10 patients receiving Symtuza.
Icelandic: Útbrot á húð geta komið fram hjá fleiri en 1 af hverjum 10 sjúklingum sem fá Symtuza.