FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to optimise the sterility assurance level (SAL) of the manufacturing process, the marketing authorisation holder should implement the measures outlined in the Post Approval Change Management Protocol (PACMP) agreed with the CHMP concerning development, validation and introduction of terminal sterilisation.
Icelandic: Til þess að hámarka fullvissustig sæfingar í framleiðsluferlinu á markaðsleyfishafi að koma á mælingum sem skilgreindar eru í PACMP (post approval change management protocol) í samráði við CHMP m.t.t þróunar, gildingar og innleiðingar lokasæfingar.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with PREVYMIS in one or more subsets of the paediatric population for prophylaxis of cytomegalovirus infection (see section 4.2 for information on paediatric use).
Icelandic: Lyfjastofnun Evrópu hefur frestað kröfu um að lagðar séu fram niðurstöður úr rannsóknum á PREVYMIS hjá einum eða fleiri undirhópum barna við fyrirbyggjandi meðferð við cytomegaloveirusýkingu (sjá upplýsingar í kafla 4.2 um notkun handa börnum).
English: Medicinal products metabolised by CYP2B6, UGT1A1 or transported by BCRP or OATP2B1 Letermovir is a general inducer in vivo but has also been observed to inhibit CYP2B6, UGT1A1, BCRP, and OATP2B1 in vitro.
Icelandic: Lyf sem umbrotna fyrir tilstilli CYP2B6, UGT1A1 eða eru flutt með BCRP eða OATP2B1 Letermovir er hefðbundinn virkir in vivo en hefur einnig sést hamla CYP2B6, UGT1A1, BCRP og OATP2B1 in vitro.
English: -Examples of such medicinal products include warfarin, voriconazole, diazepam, lansoprazole, omeprazole, esomeprazole, pantoprazole, tilidine, tolbutamide (see Table 1).
Icelandic: -Dæmi um slík lyf eru m.a. warfarin, voriconazol, diazepam, lansoprazol, omeprazol, esomeprazol, pantoprazol, tilidin, tolbutamid (sjá töflu 1).
English: It is unknown whether letermovir is excreted in human milk.
Icelandic: Ekki er þekkt hvort letermovir skiljist út í brjóstamjólk.
English: -An example of a medicinal product which is mainly eliminated by CYP2C8 is repaglinide (see Table 1).
Icelandic: -Dæmi um lyf þar sem brotthvarf verður aðallega fyrir tilstilli CYP2C8 er repaglinid (sjá töflu 1).
English: One subject had a letermovir-resistant GV (V236M).
Icelandic: Einn þátttakandi var með letermovirónæmt arfgerðarafbrigði (V236M).
English: Letermovir unbound AUC was approximately 81%- and 4-fold higher in subjects with moderate (Child-Pugh Class B [CP-B], score of 7-9) and severe (Child-Pugh Class C [CP-C], score of 10-15) hepatic impairment, respectively, compared to healthy subjects.
Icelandic: AUC fyrir óbundið letermovir var u.þ.b. 81% hærra við meðalskerta lifrarstarfsemi (Child-Pugh flokkur B [CP-B], stig 7-9) og 4 falt hærra við alvarlega skerta lifrarstarfsemi (Child-Pugh flokkur C [CP-C], stig 10-15) samanborið við hjá heilbrigðum þátttakendum.
English: (CYP2C8 induction, CYP2C8 and OATP1B inhibition)
Icelandic: (CYP2C8 virkjun, CYP2C8 og OATP1B hömlun)
English: In vitro, letermovir is an inhibitor of CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1, and OAT3 at in vivo relevant concentrations.
Icelandic: In vitro er letermovir hemill CYP3A, CYP2C8, CYP2B6, BCRP, UGT1A1, OATP2B1 og OAT3 við þéttni sem er sambærileg in vivo.
English: These data are the effect of rifampicin on letermovir 24 hours after final rifampicin dose.
Icelandic: Þessar upplýsingar eru áhrif rifampicins á letermovir 24 klst. eftir lokaskammt rifampicins.
English: Mismatched unrelated (n=43, 24)
Icelandic: Misræmi óskyldur (n=43, 24)
English: PREVYMIS is not recommended in pregnancy.
Icelandic: PREVYMIS er ekki ráðlagt á meðgöngu.
English: Elderly No dose adjustment of PREVYMIS is required based on age (see sections 5.1 and 5.2).
Icelandic: Aldraðir Ekki þarf að aðlaga skammta PREVYMIS út frá aldri (sjá kafla 5.1 og 5.2).
English: • Take PREVYMIS at the same time every day.
Icelandic: PREVYMIS á að taka á sama tíma dagsins, dag hvern.
English: -Examples of medicinal products transported by OAT3 includes ciprofloxacin, tenofovir, imipenem, and cilastin.
Icelandic: -Dæmi um lyf sem eru flutt með OAT3 eru m.a. ciprofloxacin, tenofovir, imipenem og cilastin.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og þynnu á eftir EXP.
English: The magnitude of the OATP1B1/3 inhibition on co-administered medicinal products is likely greater when PREVYMIS is co-administered with cyclosporine (a potent OATP1B1/3 inhibitor).
Icelandic: Umfang OATP1B1/3 hömlunar á lyf sem gefin eru samhliða er líklega meira þegar PREVYMIS er gefið samhliða cyclosporini (öflugur OATP1B1/3 hemill).
English: PREVYMIS is not recommended during pregnancy and in women of childbearing potential not using contraception.
Icelandic: PREVYMIS er hvorki ætlað til notkunar á meðgöngu né handa konum á barneignaraldri sem ekki nota getnaðarvarnir.
English: PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Icelandic: Notkun PREVYMIS er ekki ráðlögð hjá sjúklingum með alvarlega skerta (Child-Pugh flokkur C) lifrarstarfsemi (sjá kafla 5.2).
English: Do not use the vial if the solution is discoloured or contains visible particles.
Icelandic: Ekki á að nota hettuglasið ef lausnin er mislit eða inniheldur sjáanlegar agnir.
English: Inhibitors of P-gp/BCRP
Icelandic: P-gp/BCRP hemlar
English: Effect of letermovir on other medicinal products
Icelandic: Áhrif letermovirs á önnur lyf
English: Type I (30 mL) clear glass vial with a 20 mm fluorocoated chlorobutyl stopper with aluminium flip-off cap containing 12 mL(medium green cap) or 24 mL (dark blue cap) of solution.
Icelandic: Tegund I (30 ml) glært gler hettuglas með 20 mm flúorhúðuðum klórbútýltappa með álhettu og inniheldur 12 ml (græn hetta) eða 24 ml (dökkblá hetta) af lausn.
English: HIV medicinal products efavirenz
Icelandic: Lyf við HIV sýkingu efavirenz
English: There was no developmental toxicity observed up to the highest exposure tested (2-fold the AUC at the RHD).
Icelandic: Engin eiturverkun á þroska kom fram við allt að mestu útsetningu sem var prófuð (2-falt AUC við ráðlagða skammta hjá mönnum).
English: The relevance to humans is unknown.
Icelandic: Þýðing þessa fyrir menn er ekki þekkt.
English: Use of letermovir prophylaxis for greater than 100 days requires a careful assessment of the benefit-risk balance.
Icelandic: Fyrirbyggjandi notkun letermovirs lengur en í 100 daga krefst vandlegs mats á ávinningi og áhættu.
English: Letermovir may increase or decrease the plasma concentrations of repaglinide.
Icelandic: Letermovir getur aukið eða minnkað plasmaþéttni repaglinids.
English: 95% CIs and p-value for the treatment differences in percent response were calculated using stratumadjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (high or low risk).
Icelandic: 95% öryggismörk og p-gildi fyrir meðferðarmun sem hlutfall svörunar var reiknað út með MantelHaenszel prófi aðlöguðu að lagskiptingu þar sem vægi mismunar var eftir þýddu meðaltali eftir stærð úrtaks í meðferðarhóp fyrir hvert lag (mikil eða lítil áhætta).
English: However, caution is advised if P-gp/BCRP inhibitors are added to letermovir combined with cyclosporine.
Icelandic: Samt sem áður er ráðlagt að gæta varúðar ef P-gp/BCRP hemlum er bætt við letermovir samhliða cyclosporini.
English: Irreversible testicular toxicity and impairment of fertility was observed in male rats, but not in male mice or male monkeys.
Icelandic: Óafturkræf eiturverkun á eistu og skert frjósemi kom fram hjá karlkynsrottum en hvorki hjá karlkynsmúsum né karlkynsöpum.
English: This medicinal product must not be used with other intravenous bags and infusion set materials except those mentioned in section 6.6.
Icelandic: Lyfið má ekki nota með öðrum efnum sem eru í innrennslispokum og innrennslissettum en kemur fram í kafla 6.6.
English: Hydroxypropylbetadex (cyclodextrin) Sodium chloride
Icelandic: Hydroxypropylbetadex (cyclodextrin)
English: For adequate contraceptive effect to be ensured with an oral contraceptive, products containing EE and LNG should be chosen.
Icelandic: Til að tryggja fullnægjandi getnaðarvörn með getnaðarvarnarlyfjum til inntöku, ætti að velja lyf sem innihalda EE og LNG.
English: The net effect in vivo on the other listed enzymes and transporters is not known.
Icelandic: Hrein áhrif in vivo á önnur ensím og ferjur sem talin hafa verið upp eru ekki þekkt.
English: In the fertility and early embryonic development studies in the rat, there were no effects of letermovir on female fertility.
Icelandic: Í rannsóknum á frjósemi og rannsóknum snemma á fósturskeiði hjá rottum hafði letermovir engin áhrif á frjósemi kvendýra.
English: In a Phase 2b trial evaluating letermovir doses of 60, 120, or 240 mg/day or placebo for up to 84 days in 131 HSCT recipients, DNA sequence analysis of a select region of UL56 (amino acids 231 to 369) was performed on samples obtained from 12 letermovir-treated subjects who experienced prophylaxis failure and for whom samples were available for analysis.
Icelandic: Í 2b. stigs rannsókn þar sem letermovir var metið í skömmtunum 60, 120 og 240 mg/sólarhring eða lyfleysu í allt að 84 daga hjá 131 einstaklingi sem hafði fengið blóðmyndandi stofnfrumuígræðslu, var DNA raðgreining á völdu svæði UL56 (amínósýrur 231 til 369) gerð á sýnum frá 12 einstaklingum þar sem fyrirbyggjandi meðferð með letermoviri hafði brugðist og sýni til greiningar voru aðgengileg.
English: Each mL of concentrate contains 20 mg/mL.
Icelandic: Hver ml af þykkni inniheldur 20 mg/ml.
English: • alfentanil - for severe pain
Icelandic: • alfentanil - við miklum verkjum
English: Letermovir was initiated after HSCT (Day 0-28 post-transplant) and continued through Week 14 post-transplant.
Icelandic: Notkun letermovirs var hafin eftir blóðmyndandi stofnfrumuígræðslu (dag 028 eftir ígræðslu) og haldið áfram út viku 14 eftir ígræðslu.
English: Concomitant administration with pimozide (see sections 4.4 and 4.5).
Icelandic: Gjöf samhliða pimozidi (sjá kafla 4.4 og 4.5).
English: The following adverse reactions were identified in patients taking PREVYMIS in clinical trials.
Icelandic: Eftirfarandi aukaverkanir komu fram hjá sjúklingum sem fengu PREVYMIS í klínískum rannsóknum.
English: Monitoring of amiodarone concentrations should be performed regularly when amiodarone is co-administered with PREVYMIS
Icelandic: Fylgjast á reglulega með þéttni amiodarons þegar amiodaron er gefið samhliða PREVYMIS
English: Urinary excretion of letermovir was negligible (<2% of dose).
Icelandic: Útskilnaður letermovirs í þvagi var hverfandi (<2% af skammti).
English: List of compatible medicinal products when PREVYMIS and medicinal products* are prepared in 0.9% sodium chloride
Icelandic: Listi með samrýmanlegum lyfjum þegar PREVYMIS og lyfin* eru útbúin í 0,9% natríumklóríð lausn
English: Plasma concentrations of medicinal products transported by OAT3 may be increased.
Icelandic: Plasmaþéttni lyfja sem eru flutt með OAT3 getur aukist.
English: Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels.
Icelandic: Letermovir getur dregið úr útsetningu fyrir CYP2C9 og/eða CYP2C19 hvarfefnum sem hugsanlega leiðir til þéttni undir meðferðargildum.
English: Among the 565 treated subjects, 373 subjects received letermovir (including 99 subjects who received at least one IV dose) and 192 received placebo (including 48 subjects who received at least one IV dose).
Icelandic: Af 565 einstaklingum sem fengu meðferð, fengu 373 letermovir (þ. á m. 99 sem fengu a.m.k. einn skammt í bláæð) og 192 fengu lyfleysu (þ. á m.
English: PREVYMIS is a medicine for adults who have recently had a bone marrow transplant.
Icelandic: PREVYMIS er lyf ætlað fullorðnum sem hafa nýlega gengist undir beinmergsígræðslu.
English: Letermovir is partly eliminated by glucuronidation mediated by UGT1A1/1A3.
Icelandic: Brotthvarf letermovirs er að hluta til vegna glucurontengingar fyrir tilstilli UGT1A1/1A3.
English: In a Phase 3 trial (P001), DNA sequence analysis of the entire coding regions of UL56 and UL89 was performed on samples obtained from 22 letermovir-treated subjects, in the FAS population who experienced prophylaxis failure and for whom samples were available for analysis.
Icelandic: Í 3. stigs rannsókn (P001) var gerð raðgreining á DNA á öllu kóðaða svæði UL56 og UL89 á sýnum frá 22 einstaklingum sem höfðu fengið meðferð með letermoviri, úr heildarþýðinu þar sem fyrirbyggjandi meðferð hafði brugðist og sýni til greiningar voru aðgengileg.
English: No known letermovir resistance mutations map to UL89.
Icelandic: Engin þekkt stökkbreyting letermovirsónæmis er á UL89.
English: Concomitant administration with St. John's wort (Hypericum perforatum) (see section 4.5).
Icelandic: Gjöf samhliða jóhannesarjurt (Hypericum perforatum) (sjá kafla 4.5).
English: If a vial is added to a 250 mL IV diluent bag, the final concentration ranges of letermovir would be 0.9 mg/mL (for 240 mg dose) and 1.8 mg/mL (for 480 mg dose).
Icelandic: Ef innihaldi hettuglass er bætt út í 250 ml innrennslispoka er endanlegur styrkleiki letermovirs 0,9 mg/ml (fyrir 240 mg skammt) og 1,8 mg/ml (fyrir 480 mg skammt).
English: • If you forget a dose, take it as soon as you remember.
Icelandic: Ef skammtur gleymist á að taka hann um leið og munað er eftir því.
English: Rifampicin co-administration resulted in an initial increase in letermovir plasma concentrations (due to OATP1B1/3 and/or P-gp inhibition) that is not clinically relevant, followed by clinically relevant decreases in letermovir plasma concentrations (due to induction of P-gp/UGT) with continued rifampicin co-administration (see Table 1).
Icelandic: Gjöf rifampicins samhliða leiddi í upphafi til aukningar á plasmaþéttni letermovirs (vegna OATP1B1/3 og/eða P-gp hömlunar) sem ekki skiptir máli klínískt og í kjölfarið lækkunar á plasmaþéttni letermovirs sem skiptir máli klínískt (vegna virkjunar á P-gp/UGT) við áframhaldandi samhliðagjöf rifampicins (sjá töflu 1).
English: Co-administration of PREVYMIS and carbamazepine or phenobarbital is not recommended.
Icelandic: Gjöf PREVYMIS samhliða carbamazepini eða phenobarbitali er ekki ráðlögð.
English: (CYP3A, OATP1B1/3 inhibition)
Icelandic: (CYP3A, OATP1B1/3 hömlun)
English: In vivo studies are available investigating the net effect on CYP3A4, P-gp, OATP1B1/3 additionally on CYP2C19.
Icelandic: Til eru in vivo rannsóknir þar sem hrein áhrif á CYP3A4, P-gp, OATP1B1/3 til viðbótar við CYP2C19 hafa verið rannsökuð.
English: CMV mutants with reduced susceptibility to letermovir have been confirmed in cell culture.
Icelandic: Stökkbreytt afbrigði CMV með minnkað næmi fyrir letermoviri hafa verið staðfest í frumuræktun.
English: - Examples of medicinal products transported by BCRP include rosuvastatin and sulfasalazine.
Icelandic: - Dæmi um lyf sem eru flutt með BCRP eru m.a. rosuvastatin og sulfasalazin.
English: Letermovir was not genotoxic in a battery of in vitro or in vivo assays, including microbial mutagenesis assays, chromosomal aberration in Chinese Hamster Ovary cells, and in an in vivo mouse micronucleus study.
Icelandic: Letermovir hafði ekki eiturverkun á erfðaefni í röð in vitro eða in vivo greininga þ.m.t. í greiningu á framköllun stökkbreytinga hjá örverum, litningafrávikum í eggjastokkafrumum úr kínverskum hömstrum og í in vivo örkjarnarannsókn á músum.
English: Administration See section 4.2.
Icelandic: Sjá viðbótarupplýsingar í kafla 4.2.
English: With NC=F approach, failure was defined as all subjects with clinically significant CMV infection or who prematurely discontinued from the study or had a missing outcome through Week 24 post-transplant visit window.
Icelandic: Með NC=F nálguninni var meðferðarbrestur skilgreindur sem allir þátttakendur með klínískt mikilvæga CMV sýkingu eða sem hættu of snemma í rannsókninni eða niðurstöður vantaði á heimsóknartímabili 24 vikum eftir ígræðslu.
English: (CYP3A inhibition)
Icelandic: (CYP3A hömlun)
English: If it is time for the next dose, skip the missed dose and go back to the regular schedule.
Icelandic: Ef komið er að næsta skammti á að sleppa skammtinum sem gleymdist og halda áfram samkvæmt venjulegri áætlun.
English: Administration of PREVYMIS may result in a clinically relevant decrease in plasma concentrations of co-administered medicinal products that are significantly transported by P-gp in the intestine such as dabigatran and sofosbuvir.
Icelandic: Gjöf PREVYMIS getur leitt til klínískt mikilvægrar lækkunar á plasmaþéttni lyfja sem gefin eru samhliða og sem eru að miklu leyti flutt með P-gp í þörmum eins og dabigatran og sofosbuvir.
English: • statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
Icelandic: • statín t.d. atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - við háu kólesteróli
English: The adverse reactions are listed below by body system organ class and frequency.
Icelandic: Aukaverkanirnar eru taldar upp samkvæmt líffærakerfi og tíðni.
English: (OATP1B1/3 inhibition CYP3A inhibition, CYP2C9 induction)
Icelandic: (OATP1B1/3 hömlun) CYP3A hömlun, CYP2C9 virkjun
English: Caution is advised if other OATP1B1/3 inhibitors are added to letermovir combined with cyclosporine.
Icelandic: Ráðlagt er að gæta varúðar ef öðrum OATP1B1/3 hemlum er bætt við letermovir samhliða cyclosporini.
English: Therefore, the clinical consequences of drug interactions for letermovir will be dependent on which letermovir regimen is used and whether or not letermovir is combined with cyclosporine.
Icelandic: Þess vegna munu klínísk áhrif lyfjamilliverkana fyrir letermovir vera háð meðferðaráætlun letermovirs og hvort letermovir er gefið samhliða cyclosporini eða ekki.
English: • Voriconazole
Icelandic: Voriconazol
English: Letermovir was absorbed rapidly with a median time to maximum plasma concentration (Tmax) of 1.5 to 3.0 hours and declined in a biphasic manner.
Icelandic: Letermovir frásogast hratt með miðgildi tíma fram að hámarksþéttni í plasma (Tmax) 1,5 til 3,0 klst.
English: Letermovir - Placebo Difference (%) and 95% C.I.
Icelandic: Letermovir - lyfleysa, mismunur (%) og 95% öryggisbil
English: • swelling of hands or feet
Icelandic: • þroti á höndum og fótum.
English: After uptake, glucuronidation of letermovir is mediated by UGT1A1 and 3.
Icelandic: Eftir upptöku er glucurontenging letermovirs með þátttöku UGT1A1 og 3.
English: Donor mismatch Matched related (n=108, 58)
Icelandic: Misræmi hjá gjafa Samræmi blóðskyldur (n=108, 58)
English: Table 1 provides a listing of established or potentially clinically significant medicinal product interactions.
Icelandic: Í töflu 1 eru taldar upp staðfestar eða hugsanlega klínískt marktækar lyfjamilliverkanir.
English: Subjects were monitored through Week 24 post-transplant for the primary efficacy endpoint with continued follow-up through Week 48 post-transplant.
Icelandic: 24 eftir ígræðslu með tilliti til aðalendapunkts verkunar með áframhaldandi eftirfylgni út viku 48 eftir ígræðslu.
English: Mismatched related (n=52, 18) Matched unrelated (n=122, 70)
Icelandic: Misræmi blóðskyldur (n=52, 18) Samræmi óskyldur (n=122, 70)
English: Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide yellow (E172), iron oxide red (only for 480 mg tablets) (E172), carnauba wax (E903).
Icelandic: Laktósaeinhýdrat, hypromellósi (E464), titantvíoxíð (E171), triacetín (E1518), gult járnoxíð (E172), rautt járnoxíð (aðeins 480 mg töflur) (E172), karnabauvax (E903).
English: Approach to handling missing values: Non-Completer=Failure (NC=F) approach.
Icelandic: Þeir sem luku ekki meðferð=meðferðarbrestur (NonCompleter=Failure (NC=F)).
English: However, if it is nearly time for the next dose, skip the missed dose.
Icelandic: Ef stutt er í næsta skammt á þó að sleppa skammtinum sem gleymdist.
English: Some saturation was observed at lower concentrations.
Icelandic: Einhver mettun sást við lægri þéttni.
English: Letermovir unbound AUC was approximately 115- and 81% higher in subjects with moderate (eGFR of 31.0 to 56.8 mL/min/1.73m2) and severe (eGFR of 11.9 to 28.1 mL/min/1.73m2) renal impairment, respectively, compared to healthy subjects.
Icelandic: AUC fyrir óbundið letermovir var u.þ.b. 115% hærra við meðalskerta nýrnastarfsemi (áætlaður gaukulsíunarhraði 31,0 til 56,8 ml/mín./1,73m2) og 81% hærra við alvarlega skerta nýrnastarfsemi (áætlaður gaukulsíunarhraði 11,9 til 28,1 ml/mín./1,73m2), samanborið við hjá heilbrigðum þátttakendum.
English: • you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
Icelandic: ef um er að ræða ofnæmi fyrir letermoviri eða einhverju öðru innihaldsefni lyfsins (talin upp í kafla 6).
English: When changing the route of administration, or if changing immunosuppressant, the recommendation concerning co-administration should be revisited.
Icelandic: Þegar íkomuleið er breytt eða ef skipt er um ónæmisbælandi lyf skal endurskoða ráðleggingar varðandi samhliða gjöf.
English: Do not use this medicine after the expiry date which is stated on the carton and blister card after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á öskjunni og hettuglasi á eftir EXP.
English: etravirine
Icelandic: etravirin
English: One subject (who received 60 mg/day) had a letermovir resistant genotypic variant (GV) (V236M).
Icelandic: Einn þátttakandi (sem fékk 60 mg/sólarhring) var með letermovirónæmt arfgerðarafbrigði (V236M).
English: The primary efficacy endpoint of clinically significant CMV infection in P001 was defined by the incidence of CMV DNAemia warranting anti-CMV pre-emptive therapy (PET) or the occurrence of CMV end-organ disease.
Icelandic: Aðalendapunktur verkunar fyrir klínískt mikilvæga CMV sýkingu í P001 var skilgreindur samkvæmt CMV DNA í blóði sem gaf tilefni til CMV hindrandi meðferðar við sjúkdómnum (pre-emptive therapy (PET)) eða að fram kom sjúkdómur í marklíffæri af völdum CMV.
English: Dose adjustment of CYP3A metabolised opioids may be needed
Icelandic: Hugsanlega þarf að aðlaga skammt CYP3A umbrotinna ópíóíða
English: (P-gp/UGT induction)
Icelandic: (P-gp/UGT virkjun)
English: Induction may give rise to reduced plasma concentrations of some metabolised and transported medicinal products (see section 4.5).
Icelandic: Virkjun getur dregið úr plasmaþéttni nokkurra umbrotinna og ferjaðra lyfja (sjá kafla 4.5).
English: PREVYMIS concentrate for solution for infusion is physically incompatible with amiodarone hydrochloride, amphotericin B (liposomal), aztreonam, cefepime hydrochloride, ciprofloxacin, cyclosporine, diltiazem hydrochloride, filgrastim, gentamicin sulfate, levofloxacin, linezolid, lorazepam, midazolam HCl, mycophenolate mofetil hydrochloride, ondansetron, palonosetron.
Icelandic: PREVYMIS innrennslisþykkni, lausn er eðlisfræðilega ósamrýmanlegt amiodaron hýdróklóríði, amphotericin B (liposomal), aztreonami, cefepim hýdróklóríði, ciprofloxacini, cyclosporini, diltiazem hýdróklóríði, filgrastim, gentamicin súlfati, levofloxacini, linezolidi, lorazepami, midazolam hýdróklóríði, mycophenolat mofetil hýdróklóríði, ondansetroni, palonosetroni.
English: Each mL contains 20 mg of letermovir.
Icelandic: Hver ml inniheldur 20 mg letermovir.
English: Carbamazepine or phenobarbital may decrease plasma concentrations of letermovir.
Icelandic: Carbamazepin eða phenobarbital geta dregið úr plasmaþéttni letermovirs.
English: This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.
Icelandic: Þetta jafngildir 1,15% af ráðlögðum heildardagskammti af neyslu natríums úr fæðu hjá fullorðnum.
English: Close monitoring and/or dose adjustment of co-administered CYP3A substrates is recommended (see section 4.5).
Icelandic: Náið eftirlit og/eða skammtaaðlögun CYP3A hvarfefna sem notuð eru samhliða er ráðlagt (sjá kafla 4.5).
English: - An example of a medicinal product transported by OATP2B1 is celiprolol.
Icelandic: - Dæmi um lyf sem eru flutt með OATP2B1 er celiprolol.
English: Medicinal products transported by OATP1B1/3
Icelandic: Lyf flutt af OATP1B1/3