FrancophonIA/ELRC3.0 huggingface dataset:
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in drop seizure frequency during the treatment period in each trial (11% 10 mg/kg/day cannabidiol, 31% to 36% 20 mg/kg/day cannabidiol, 3% to 7% placebo).
Icelandic: Aðrar niðurstöðumælingar hjá undirhópi sjúklinga sem fengu samhliða meðferð með klóbazami Kannabídíól tengdist prósentuaukningu þátttakenda sem upplifðu 75% eða meiri minnkun á tíðni hreyfitregðufloga meðan á meðferðartímabilinu stóð í hverri rannsókn (11% 10 mg/kg/sólarhring kannabídíól, 31% til 36% 20 mg/kg/sólarhring kannabídíól, 3% til 7% lyfleysa).
English: Metabolism
Icelandic: Klóbazam
English: GWPCARE4 Placebo 20 mg/kg/day p=0.0043
Icelandic: GWPCARE4 Lyfleysa 20 mg/kg/sólarhring 44,2% 86 p = 0,0043
English: Other medicines and Epidyolex
Icelandic: Notkun annarra lyfja samhliða Epidyolex
English: Very common Somnolencea Common
Icelandic: Mjög algengar Svefnhöfgia
English: Excretion
Icelandic: Útbrot
English: A NOAEL of 15 mg/kg/day was established.
Icelandic: 15 mg/kg/sólarhring voru staðfest.
English: Hepatocellular injury Cannabidiol causes dose-related elevations of ALT and AST (see section 4.4).
Icelandic: Lifrarfrumuskemmd Kannabídíól veldur skammtaháðri hækkun ALAT og ASAT (sjá kafla 4.4).
English: The pharmacokinetics of cannabidiol are complex and may cause interactions with the patient's concomitant AED treatments.
Icelandic: Lyfjahvarfafræði kannabídíóls er flókin og kann að valda milliverkunum við flogaveikilyf sem gefin eru samhliða.
English: Subgroup analyses were conducted on multiple factors, including cAEDs.
Icelandic: Greiningar voru gerðar á undirhópum vegna margra þátta, þ.m.t. samhliða notkun flogaveikilyfja.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Icelandic: Heilbrigðisstarfsmenn eru hvattir til að tilkynna allar aukaverkanir sem grunur er um að tengist lyfinu samkvæmt fyrirkomulagi sem gildir í hverju landi fyrir sig, sjá Appendix V.
English: Cannabidiol does not interact with the major renal and hepatic transporters in a way that is likely to result in relevant drug-drug interactions.
Icelandic: Kannabídíól hefur ekki milliverkanir við helstu flutningsprótein í nýrum og lifur með þeim hætti sem er líklegur til að valda milliverkunum milli lyfja svo nokkru nemi.
English: Open-label data
Icelandic: Upplýsingar úr opnum rannsóknum
English: How to store Epidyolex
Icelandic: Hvernig geyma á Epidyolex
English: 20 mg/kg/day p=0.0123
Icelandic: 20 mg/kg/sólarhring p = 0,0123
English: No effects on cannabidiol or metabolite exposures were observed following administration of a single dose of cannabidiol 200 mg in subjects with mild hepatic impairment.
Icelandic: Ekki komu fram áhrif á útsetningu fyrir kannabídíóli eða umbrotsefnum þess í kjölfar gjafar á stökum 200 mg skammti af kannabídíóli hjá þátttakendum með væga skerðingu á lifrarstarfsemi.
English: No adverse reactions were observed on male or female fertility or reproduction performance in rats at doses up to 250 mg/kg/day (approximately 60-fold greater than the maximum recommended human dose (MRHD) at 20 mg/kg/day).
Icelandic: Engar aukaverkanir á frjósemi hjá karl- eða kvendýrum eða æxlunargetu komu fram hjá rottum við skammta upp að 250 mg/kg/sólarhring (u.þ.b.
English: Greater improvements in overall condition, as measured by Global Impression of Change scores at the last visit, were reported by caregivers and patients with both doses of cannabidiol (73% on
Icelandic: Bæði umönnunaraðilar og sjúklingar með báða skammta af kannabídíóli greindu frá meiri bætingu á almennu ástandi, mældu með GIC-stigum (Global Impression of Change) við síðustu heimsókn (73% sem fengu
English: Cannabidiol was associated with an increase in the percentage of subjects experiencing a greater than or equal to 75% reduction in convulsive seizure frequency during the treatment period in each trial (36% 10 mg/kg/day cannabidiol, 25% for each 20 mg/kg/day cannabidiol group, 10% to 13% placebo).
Icelandic: Aðrar niðurstöðumælingar hjá undirhópi sjúklinga sem fengu samhliða meðferð með klóbazami Kannabídíól tengdist prósentuaukningu þátttakenda sem upplifðu 75% eða meiri minnkun á tíðni flogakrampa meðan á meðferðartímabilinu stóð í hverri rannsókn (36% fyrir 10 mg/kg/sólarhring kannabídíól, 25% fyrir hvorn 20 mg/kg/sólarhring kannabídíól hóp, 10% til 13% lyfleysa).
English: Five percent (5%) of patients (all on valproate) taking cannabidiol 10 mg/kg/day experienced ALT elevations greater than 3 times the ULN when ALT was above the ULN at baseline, compared with 3% of patients (all on valproate) in whom ALT was within the normal range at baseline.
Icelandic: Þegar upphafsgildi ALAT voru yfir efri viðmiðunarmörkum kom fram ALAT-hækkun sem var yfir þreföldum efri viðmiðunarmörkum hjá fimm prósentum (5%) sjúklinga (allir fengu valpróat) sem fengu kannabídíól 10 mg/kg/sólarhring samanborið við 3% (allir fengu valpróat) þegar upphafsgildi ALAT voru innan eðlilegra viðmiðunarmarka.
English: 1 mg/kg twice daily (2 mg/kg/day)
Icelandic: 1 mg/kg tvisvar á sólarhring (2 mg/kg/sólarhring)
English: Starting Dose
Icelandic: Meðferð hætt
English: Line up the end of the plunger with the volume marking required, as shown opposite.
Icelandic: Stilltu enda sprautustimpilsins af þannig að hann nemi við rétta rúmmálsmerkingu, eins og sýnt er hér til hliðar.
English: For an adult weighing 70 kg, this is equivalent to 14 millilitres (ml) of beer, or 6 ml of wine per dose.
Icelandic: Þetta jafngildir 14 ml af bjór eða 6 ml af léttvíni í skammti ef miðað er við fullorðinn einstakling sem vegur 70 kg.
English: In vivo assessment of drug interactions
Icelandic: In vivo mat á lyfjamilliverkunum
English: 20 mg/kg/day p=0.0299
Icelandic: 20 mg/kg/sólarhring p = 0,0299
English: 10 mg/kg/day p=0.0095
Icelandic: 10 mg/kg/sólarhring p = 0,0095
English: Warnings and precautions Talk to your doctor or pharmacist before taking Epidyolex or during treatment if: - you have or have had liver problems, as your doctor may need to change the dose of Epidyolex or may decide that Epidyolex is not appropriate for you.
Icelandic: - þú ert með eða hefur fengið lifrarsjúkdóma, þá gæti læknirinn þurft að aðlaga skammtinn af Epidyolex eða ákveðið að Epidyolex henti þér ekki.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot
Icelandic: 13. LOTUNÚMER, AUÐKENNI GJAFAR OG LYFS Lot
English: LIST OF EXCIPIENTS Contains refined sesame oil, ethanol and strawberry flavour components (including benzyl alcohol).
Icelandic: HJÁLPAREFNI Inniheldur hreinsaða sesamolíu, etanól og jarðaberjabragðefni (þ.m.t. bensýlalkóhól).
English: Adverse reactions reported with cannabidiol in placebo-controlled clinical studies are listed in the table below by System Organ Class and frequency.
Icelandic: Í töflunni hér að neðan eru taldar upp aukaverkanir af kannabídíóli sem greint var frá í klínískum samanburðarrannsóknum með lyfleysu, aukaverkanirnar eru taldar upp eftir líffæraflokkum og tíðni.
English: Pneumoniaa, Bronchitis, Nasopharyngitis, Urinary tract infection
Icelandic: Lungnabólgaa, berkjubólga, nefkoksbólga, þvagfærasýking
English: 0.5 mg/kg twice daily (1 mg/kg/day)
Icelandic: 0,5 mg/kg tvisvar á sólarhring (1 mg/kg/sólarhring)
English: 5 mg/kg twice daily (10 mg/kg/day)
Icelandic: 5 mg/kg tvisvar á sólarhring (10 mg/kg/sólarhring)
English: Data for study GWPCARE2 and the with clobazam subgroup are presented as percent reduction from baseline estimated from a negative binomial regression analysis.
Icelandic: Gögn fyrir rannsókn GWPCARE2 og undirhóp sem tók klóbazam eru sýnd sem prósentulækkun frá upphafsgildi sem áætluð er frá neikvæðri tvíkosta aðhvarfsgreiningu.
English: Patients with sustained transaminase elevations of greater than 5 times the ULN should also have treatment discontinued.
Icelandic: Einnig skal hætta meðferð hjá sjúklingum þar sem viðvarandi hækkun á transamínasa er yfir fimmföldum efri viðmiðunarmörkum.
English: Mutagenicity
Icelandic: Algengar
English: c Nominal p-value.
Icelandic: c Nafngildi p. d P-heildargildið byggir
English: Table 4 summarises the primary endpoint of percent reduction from baseline in convulsive seizures, and the key secondary measure of proportion of patients with at least a 50% reduction in convulsive seizure frequency, as well as results of the subgroup analysis for these outcome measures in patients treated with concomitant clobazam.
Icelandic: 50% fækkun varð á tíðni flogakrampa, ásamt niðurstöðu greiningar undirhópa fyrir þessa mælikvarða hjá sjúklingum sem fengu samhliða meðferð með klóbazami.
English: You may get the following side effects with this medicine.
Icelandic: Eftirfarandi aukaverkanir geta komið fram við notkun á þessu lyfi:
English: The mechanism of this interaction remains unknown.
Icelandic: Enn er ekki vitað hvernig þessi milliverkun á sér stað.
English: GWPCARE3 10 mg/kg/day p=0.0016
Icelandic: GWPCARE3 10 mg/kg/sólarhring 19,2
English: The mechanism of this interaction is unknown.
Icelandic: Ekki er vitað hvernig þessi milliverkun á sér stað.
English: Read all of this leaflet carefully before you or the patient start taking this medicine because it contains important information for you or the patient
Icelandic: Lesið allan fylgiseðilinn vandlega áður en byrjað er að nota lyfið.
English: a For study GWPCARE1, overall data are presented as median percent reduction from baseline.
Icelandic: CI = 95% öryggisbil a Fyrir rannsókn GWPCARE1 eru heildargögn sýnd sem miðgildi prósentulækkunar frá upphafsgildi.
English: Moderate 1.25 mg/kg twice daily (2.5 mg/kg/day)
Icelandic: Ráðlagður hámarksskammtur Miðlungsmikil 1,25 mg/kg tvisvar á sólarhring (2,5 mg/kg/sólarhring)
English: Reporting of side effects
Icelandic: Stökkbreytandi áhrif
English: How to take Epidyolex.
Icelandic: Hvernig nota á Epidyolex
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children
Icelandic: SKULI GEYMT ÞAR SEM BÖRN HVORKI NÁ TIL NÉ SJÁ
English: NAME OF THE MEDICINAL PRODUCT Epidyolex 100 mg/ml oral solution
Icelandic: HEITI LYFS Epidyolex 100 mg/ml mixtúra, lausn
English: 20 mg/kg/day p=0.0069
Icelandic: 20 mg/kg/sólarhring p = 0,0069
English: Hepatic impairment
Icelandic: Meðferð ofskömmtunar
English: Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted: - other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam,
Icelandic: - önnur flogaveikilyf, svo sem karbamazepín, klóbazam, lamótrigín, lórasepam, mídazólam,
English: If a patient develops clinical signs or symptoms suggestive of hepatic dysfunction, serum transaminases and total bilirubin should be promptly measured and treatment with cannabidiol should be interrupted or discontinued, as appropriate.
Icelandic: Ef sjúklingur sýnir klínísk teikn eða einkenni sem benda til truflunar á lifrarstarfsemi skal tafarlaust mæla transamínasa í sermi og heildarbílírúbín og gera skal hlé á meðferð með kannabídíóli eða stöðva meðferð, eftir því sem við á. Hætta skal meðferð með kannabídíóli hjá sjúklingum með hækkun á transamínasa sem er yfir þreföldum eðlilegum efri viðmiðunarmörkum og hækkun á bílírúbíni sem er yfir tvöföldum efri viðmiðunarmörkum (ULN).
English: Skin and subcutaneous tissue disorders Common
Icelandic: Húð og undirhúð
English: Given that there was no consistent dose response between 10 mg/kg/day and 20 mg/kg/day in the LGS and DS studies, cannabidiol should be titrated initially to the recommended maintenance dose of 10 mg/kg/day (see Section 4.2).
Icelandic: á Lennox-Gastaut heilkenni eða Dravet heilkenni skal byrja að títra kannabídíól upp að ráðlagða viðhaldsskammtinum 10 mg/kg/sólarhring (sjá kafla 4.2).
English: INFORMATION IN BRAILLE epidyolex
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI epidyolex
English: Cannabidiol and 7-OH-CBD are not substrates for or inhibitors of efflux transports P-gp/MDR1, BCRP or BSEP at clinically relevant plasma concentrations.
Icelandic: P-gp/MDR1, BCRP eða BSEP við klínískt marktæka þéttni í plasma.
English: Increased appetite
Icelandic: AÐRAR FORSENDUR
English: Table 5: Drug interactions between cannabidiol and concomitant antiepileptic drugs Concomitant AED Influence of AED on cannabidiol Influence of cannabidiol on AED Clobazam
Icelandic: Viðbótarmeðferð hjá sjúklingum með Dravet heilkenni Verkun kannabídíóls í viðbótarmeðferð við flogum sem tengjast
English: Table 4: Primary and ≥ 50% responder key secondary outcome measures and subgroup analysis in DS studies
Icelandic: 50% helstu aukaendapunktar svarenda, og greining undirhópa í rannsóknum á DS
English: • Epidyolex oral solution bottle
Icelandic: Glas með Epidyolex mixtúru, lausn
English: Adjunctive Therapy in Patients with Dravet Syndrome The efficacy of cannabidiol for the adjunctive therapy of seizures associated with Dravet syndrome (DS) was evaluated in two randomised, double-blind, placebo-controlled, parallel-group studies (GWPCARE2 and GWPCARE1).
Icelandic: Dravet heilkenni (DS) var metin í tveimur slembuðum, tvíblindum samhliða samanburðarrannsóknum með lyfleysu (GWPCARE2 og GWPCARE1).
English: 2.5 mg/kg twice daily (5 mg/kg/day)
Icelandic: 2,5 mg/kg tvisvar á sólarhring (5 mg/kg/sólarhring)
English: Co-administration of cannabidiol with a high-fat/high calorie meal increased the rate and extent of absorption (5-fold increase in Cmax and 4-fold increase in AUC) and reduced the total variability of exposure compared with the fasted state in healthy volunteers.
Icelandic: Samhliða gjöf kannabídíóls með fituríkri/hitaeiningaríkri máltíð jók bæði hraða og umfang frásogs (5-föld aukning á Cmax og 4-föld aukning á AUC) og dró úr breytileika útsetningar í heild samanborið við það sem kom fram hjá heilbrigðum sjálfboðaliðum á fastandi maga.Til að lágmarka breytileika á aðgengi kannabídíóls hjá hverjum og einum sjúklingi, skal staðla gjöf kannabídíóls í tengslum við mataræði, þar með talið ketógenískt mataræði (fituríkar máltíðir).
English: b Overall data are presented as estimated median difference and p-value from a Wilcoxon rank-sum test. Data for the with clobazam subgroup are estimated from a negative binomial regression analysis.
Icelandic: b Heildargögn eru sýnd sem miðgildisbreyting og p-gildi úr Wilcoxon-prófi á summum sætistalna.
English: Concomitant Valproate and Clobazam
Icelandic: Umbrot og brotthvarf
English: Subgroup
Icelandic: Líffæraflokkur
English: Concomitant AED treatments
Icelandic: Samhliða meðferðir með flogaveikilyfjum
English: Placebo 10 mg/kg/day 20 mg/kg/day
Icelandic: Lyfleysa 20 mg/kg/sólarhring
English: With Clobazam
Icelandic: Undirhópur með klóbazami
English: Cannabidiol does not exert its anticonvulsant effect through interaction with cannabinoid receptors.
Icelandic: Klóbazam Engin áhrif á gildi kannabídíóls.
English: Increased systemic levels of these active substances may lead to enhanced pharmacological effects and to an increase in adverse drug reactions.
Icelandic: Aukning altækra gilda þessara virku efna kann að leiða til aukinna lyfhrifa og aukinnar tíðni aukaverkana.
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ(IR)
English: Less than 1% of cannabidiol-treated patients had ALT or AST levels greater than 20 times the ULN.
Icelandic: Hjá minna en 1% sjúklinga sem fengu kannabídíól námu hækkanir
English: Interaction resulting in an increase in exposure of the active metabolite 7-OH-CBD in HV* studies.
Icelandic: Milliverkun sem leiðir til aukinnar útsetningar virka umbrotsefnisins 7-OH-CBD í rannsóknum á heilbrigðum sjálfboðaliðum.
English: The lowest dose causing developmental toxicity in juvenile rats (15 mg/kg subcutaneous/100 mg/kg oral) was associated with Cmax cannabidiol exposures approximately 20 times that in paediatric subjects at 20 mg/kg/day.
Icelandic: Lægsti skammtur sem veldur eiturverkunum á þroska hjá ungum rottum (15 mg/kg undir húð; 100 mg/kg til inntöku) tengdist
English: Clobazam
Icelandic: Umbrot
English: p<0.0001c ≥ 50% REDUCTION IN DROP SEIZURES (RESPONDER ANALYSIS) Percentage of ≥ 50% Responders, p-valued GWPCARE3 Placebo
Icelandic: Prósentuhlutfall ≥ 50% svarenda, p-gildid
English: • If your dose is 1 ml (100 mg) or less, you should use the smaller 1 ml syringe.
Icelandic: Ef skammturinn þinn er 1 ml (100 mg) eða minni skaltu nota minni 1 ml sprautuna. • Ef skammturinn þinn er stærri en 1 ml (100 mg) skaltu nota stærri 5 ml sprautuna.
English: Valproate
Icelandic: Hrvatska
English: Table 1: Dose adjustments in patients with moderate or severe hepatic impairment
Icelandic: Skammtaaðlögun hjá sjúklingum með miðlungsmikla eða verulega skerðingu á lifrarstarfsemi
English: CI=95% confidence interval.
Icelandic: CI = 95% öryggisbil; a Gögn fyrir heildarþýði eru sýnd sem miðgildi prósentulækkunar frá upphafsgildi.
English: The primary endpoint was the percentage change from baseline in drop seizures per 28 days over the treatment period for the cannabidiol group compared to placebo.
Icelandic: á 28 daga tímabili meðan á meðferð stóð hjá hópnum sem fékk kannabídíól samanborið við lyfleysu.
English: Polska Tel.: +31(0)337981015
Icelandic: Teл.: +31(0)337981015
English: No formal drug-drug interaction studies have been conducted with cannabidiol in combination with UGT inhibitors, therefore caution should be taken when co-administering drugs that are known inhibitors of these UGTs.
Icelandic: Engar formlegar rannsóknir á lyfjamilliverkunum hafa verið framkvæmdar með kannabídíóli og UGT-hemlum.
English: Resolution of transaminase elevations occurred with discontinuation of cannabidiol or reduction of cannabidiol and/or concomitant valproate in about two-thirds of the cases.
Icelandic: Í u.þ.b. tveimur af hverjum þremur tilvikum gekk hækkun á transamínasa til baka ef gjöf kannabídíóls var stöðvuð eða skammtar kannabídíóls og/eða valpróats sem gefið var samhliða voru minnkaðir.
English: Increased seizure frequency
Icelandic: Tafla yfir aukaverkanir
English: Strawberry flavour (including benzyl alcohol)
Icelandic: Jarðarberjabragðefni (þ.m.t. bensýlalkóhól)
English: Clear, colourless to yellow solution
Icelandic: LYFJAFORM Mixtúra, lausn Tær, litlaus til gul lausn
English: Cannabidiol and the metabolite 7-OH-CBD do not interact with the major renal or hepatic uptake transporters and therefore are unlikely to result in relevant drug-drug interactions: OAT1, OAT3, OCT1, OCT2, MATE1, MATE2-K, OATP1B1and OATP1B3.
Icelandic: OAT1, OAT3, OCT1, OCT2, MATE1, MATE2-K, OATP1B1 og OATP1B3.
English: Monitoring
Icelandic: Eftirlit
English: Metabolism and nutrition disorders
Icelandic: Tengsl lyfjahvarfa og lyfhrifa
English: Two 5 ml oral syringes with bottle adaptor
Icelandic: Tvær 1 ml munngjafarsprautur með millistykki fyrir glas Tvær 5 ml munngjafarsprautur með millistykki fyrir glas
English: Summary of the safety profile
Icelandic: Gögn fyrir rannsókn
English: Ethanol in the formulation
Icelandic: Etanól í lyfjasamsetningunni
English: Your existing tumour(s) may increase in size and new tumour(s) could appear while you are being treated with Imlygic.
Icelandic: Miðgildi [95% CI] 23,3 [19,5; 29,6] mánuðir Miðgildi [95% CI] 18,9 [16,0; 23,7] mánuðir
English: 30th June, 2021
Icelandic: 30. júní 2021
English: Study 005/05
Icelandic: Rannsókn 005/05
English: § American Joint Committee on Cancer (AJCC) staging 6th edition.
Icelandic: § American Joint Committee on Cancer (AJCC) greining 6. útgáfa.
English: 1 week (7 days)
Icelandic: 1 vika (7 dagar)
English: Your second injection will be given 3 weeks after the first injection.
Icelandic: Önnur inndælingin verður gefin 3 vikum eftir fyrstu inndælinguna.
English: (listed in section 6).
Icelandic: (talin upp í kafla 6).
English: • think you may be pregnant
Icelandic: þú telur að þú getir verið þunguð
English: Sorbitol (E420)
Icelandic: Sorbitól (E420)
English: All patients
Icelandic: Allir sjúklingar
English: HSV-1 seronegative patients
Icelandic: HSV-1 sermineikvæðir sjúklingar
English: 2°C to 8°C
Icelandic: 2°C til 8°C
English: Imlygic may harm your unborn baby.
Icelandic: Imlygic getur skaðað ófætt barn þitt.
English: Overall response rate (% CR, % PR)
Icelandic: Heildarsvörunarhlutfall (% CR, % PR)
English: The expiry date refers to the last day of that month.
Icelandic: Fyrningardagsetningin er síðasti dagur mánaðarins sem þar kemur fram.
English: 4.1 months
Icelandic: 4,1 mánuðir
English: Number of Patients at Risk
Icelandic: Fjöldi sjúklinga í hættu
English: The following requirements need to be fulfilled before the product is dispensed:
Icelandic: Eftirfarandi skilyrði verða að vera uppfyllt áður en lyfinu er dreift:
English: Continue until the full dose is evenly and completely dispersed.
Icelandic: Haldið áfram þar til skammturinn hefur dreifist jafnt og að fullu.
English: Do NOT shake.
Icelandic: Hristið EKKI.
English: No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
Icelandic: Enginn heildarmunur var á öryggi og verkun milli aldraðra (≥ 65 ára) og yngri, fullorðinna sjúklinga.
English: Patients with detectable DNA during treatment (n = 60)
Icelandic: Sjúklingar með greinanlegt DNA meðan á meðferð stóð (n = 60)
English: Kaplan-Meier Percent Alive
Icelandic: Kaplan-Meier hlutfall á lífi
English: The educational programme is aimed to inform about important risks associated with IMLYGIC:
Icelandic: Tilgangur fræðsluáætlunarinnar er að upplýsa um mikilvæga áhættuþætti sem eru tengdir IMLYGIC:
English: You can expect to be treated with Imlygic for at least 6 months or longer.
Icelandic: Þú getur gert ráð fyrir að fá meðferð með Imlygic í 6 mánuði eða lengur.
English: Use caution when driving or operating machinery until you are certain that Imlygic does not adversely affect you.
Icelandic: Sýndu aðgát við akstur eða stjórnun véla þar til þú ert viss um að Imlygic hafi ekki neikvæð áhrif á þig.
English: Imlygic N = 295
Icelandic: N = 295
English: This may impair your ability to drive or operate machinery.
Icelandic: Þetta getur skert getu þína til aksturs eða stjórnunar véla.
English: Tell your healthcare professional if you have or have ever had a weakened immune system, if you have
Icelandic: Láttu lækninn vita ef þú ert með eða hefur einhvern tímann verið með veiklað ónæmiskerfi, ef þú ert með
English: The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Icelandic: Miðgildi tímalengdar útsetningar fyrir Imlygic voru 23 vikur (5,3 mánuðir).
English: Imlygic also works by helping your immune system to recognise and destroy tumours throughout your body.
Icelandic: Imlygic verkar einnig með því að hjálpa ónæmiskerfinu að þekkja og eyðileggja æxli í líkamanum.
English: 3.7 months
Icelandic: 3,7 mánuðir
English: Not reached (Range: > 0.0 to > 16.8 months)
Icelandic: Ekki náð (Bil: > 0,0 til > 16,8 mánuðir)
English: 5 (19%)a aFor the anogenital area, 26 patients were tested for Imlygic DNA.
Icelandic: 5 (19%)a a Fyrir raufar- og kynfærasvæði voru 26 sjúklingar prófaðir fyrir Imlygic DNA.
English: No adjustment of the dose is required in patients ≥ 65 years old (see section 5.1).
Icelandic: Ekki er þörf á að aðlaga skammta hjá sjúklingum ≥ 65 ára (sjá kafla 5.1).
English: • Repeat these steps for other lesions that need to be injected.
Icelandic: Endurtakið þessi skref fyrir aðrar vefjaskemmdir sem þarf að dæla í.
English: Study Month
Icelandic: Mánuður rannsóknar
English: - if your healthcare professional has told you that you have a severely weakened immune system.
Icelandic: - ef læknirinn hefur sagt þér að þú sért með verulega veiklað ónæmiskerfi.
English: The mean age was 63 (range: 22 to 94) years; 26.5% were over 65 years old and 23.3% were over 74 years old.
Icelandic: 22 til 94) ár, 26,5% voru eldri en 65 ára og 23,3% voru eldri en 74 ára.
English: These symptoms generally resolve within the first 72 hours after treatment.
Icelandic: Þessi einkenni lagast venjulega innan 72 klst. frá meðferð.
English: Negligible amounts (< 0.001% of maternal blood levels) of talimogene laherparepvec DNA were found in foetal blood.
Icelandic: Hverfandi magn (< 0,001% af magni í blóði móður) talimogen laherparepvec DNA fannst í blóði fósturs.
English: You should tell your close contacts to:
Icelandic: Þú skalt segja þeim sem þú ert í nánu samneyti við að: