FrancophonIA/ELRC3.0 huggingface dataset:
English: No maternal or developmental effects were noted at the dose of 50 mg/kg/day (approximately 2.5-fold the AUC at the RHD).
Icelandic: Engin áhrif á móður eða áhrif á þroska komu fram við skammta sem voru 50 mg/kg/sólarhring (u.þ.b. 2,5-falt AUC við ráðlagða skammta hjá mönnum).
English: Clinical monitoring and dose adjustment may be needed.
Icelandic: Eftirlit með sjúklingi og aðlögun skammta getur verið nauðsynlegt.
English: (CYP2C9/19 induction)
Icelandic: (CYP2C9/19 virkjun)
English: In cases of clinically significant CMV DNAemia or disease, letermovir prophylaxis was stopped and standard-of-care pre-emptive therapy (PET) or treatment was initiated.
Icelandic: 24. Ef fram kom CMV DNA í blóði eða sjúkdómur sem var klínískt marktækur var fyrirbyggjandi notkun letermovirs hætt og hefðbundin hindrandi meðferð við sjúkdómnum (pre-emptive therapy (PET)) eða önnur meðferð hafin.
English: The safety assessment of PREVYMIS was based on a Phase 3 clinical trial (P001) in HSCT recipients who received PREVYMIS or placebo through Week 14 post-transplant and were followed for safety through Week 24 post-transplant (see section 5.1).
Icelandic: Mat á öryggi PREVYMIS grundvallast á 3. stigs klínískri rannsókn (P001) hjá einstaklingum sem höfðu fengið blóðmyndandi stofnfrumuígræðslu og sem fengu PREVYMIS eða lyfleysu út viku 14 eftir ígræðslu og var fylgt eftir með tilliti til öryggis út viku 24 eftir ígræðslu (sjá kafla 5.1).
English: Medicinal products transported by the renal transporter OAT3
Icelandic: Lyf sem eru flutt með OAT3 ferju í nýrum
English: Therapeutic drug monitoring (TDM) is therefore recommended for voriconazole.
Icelandic: Því er eftirlit með þéttni voriconazols ráðlagt.
English: Bioavailability of letermovir was estimated to be approximately 85% with 240 mg once daily oral letermovir co-administered with cyclosporine in patients.
Icelandic: Aðgengi letermovirs var metið u.þ.b. 85% eftir 240 mg af letermoviri til inntöku einu sinni á dag við samhliða gjöf cyclosporins hjá sjúklingum.
English: Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Povidone (E1201) Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Icelandic: Örkristallaður sellulósi (E460) Natríumkroskarmellósi (E468) Povidon (E1201) Vatnsfrí kísilkvoða (E551) Magnesíumstearat (E470b)
English: Although not studied, when PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in atorvastatin plasma concentrations is expected to be greater than with PREVYMIS alone.
Icelandic: Þótt það hafi ekki verið rannsakað er gert ráð fyrir að aukning á plasmaþéttni atorvastatins sé meiri þegar PREVYMIS er gefið samhliða cyclosporini en með PREVYMIS eingöngu.
English: Letermovir may increase the plasma concentrations of quinidine.
Icelandic: Letermovir getur aukið plasmaþéttni quinidins.
English: • Ganciclovir sodium
Icelandic: Ganciclovir natríum
English: Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during coadministration of PREVYMIS in combination with cyclosporine and alfentanil or fentanyl.
Icelandic: öndunarbælingar og/eða langvarandi slævingar við samhliða gjöf PREVYMIS í samsetningu með cyclosporini og alfentanili eða fentanyli.
English: PREVYMIS concentrate for solution for infusion requires dilution (see section 6.6) prior to administration.
Icelandic: PREVYMIS innrennslisþykkni, lausn þarf að þynna (sjá kafla 6.6) fyrir gjöf.
English: Additional effects of other products on letermovir relevant when combined with cyclosporine
Icelandic: Viðbótaráhrif annarra lyfja á letermovir sem skipta máli við notkun samhliða cyclosporini
English: Pink oval, bi-convex tablet of dimensions 21.2 mm x 10.3 mm, debossed with “595” on one side and MSD logo on the other side.
Icelandic: Bleik sporöskjulaga, tvíkúpt tafla 21,2 mm x 10,3 mm að stærð með „595“ á annarri hliðinni og kennimerki MSD á hinni hliðinni.
English: ↔ posaconazole AUC 0.98 (0.82, 1.17) Cmax 1.11 (0.95, 1.29)
Icelandic: ↔ posaconazol AUC 0,98 (0,82; 1,17) Cmax 1,11 (0,95; 1,29)
English: Expected: ↔ letermovir
Icelandic: Áætlað: ↔ letermovir
English: Each 480 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Icelandic: Hver 480 mg filmuhúðuð tafla inniheldur minna en 1 mmól af natríum (23 mg).
English: Based on population pharmacokinetic analyses, there is no effect of age on letermovir pharmacokinetics.
Icelandic: Byggt á greiningu á lyfjahvörfum hefur aldur engin áhrif á lyfjahvörf letermovirs.
English: Additional monitoring may be recommended; refer to the prescribing information for such medicinal products.
Icelandic: Viðbótareftirlit getur verið ráðlagt; sjá samantekt á eiginleikum þessara lyfja.
English: Co-administration of PREVYMIS with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations.
Icelandic: Samhliða gjöf PREVYMIS og lyfja sem eru hemlar OATP1B1/3 flutningspróteina getur aukið plasmaþéttni letermovirs.
English: Concomitant use of dabigatran should be avoided due to risk of reduced dabigatran efficacy.
Icelandic: Forðast á notkun dabigatrans samhliða vegna hættu á minnkaðri verkun dabigatrans.
English: When PREVYMIS is co-administered with cyclosporine, use of these statins is contraindicated.
Icelandic: Þegar PREVYMIS er gefið samhliða cyclosporini á ekki að nota þessi statín.
English: In monkeys administered letermovir, there was no evidence of testicular toxicity based on histopathologic evaluation, measurement of testicular size, blood hormone analysis (follicle stimulating hormone, inhibin B and testosterone) and sperm evaluation (sperm count, motility and morphology) at systemic exposures approximately 2-fold the AUC in humans at the RHD.
Icelandic: Hjá öpum sem fengu letermovir var ekkert sem benti til eiturverkana á eistu, byggt á vefjameinafræðilegu mati, mælingu á stærð eista, greiningu á hormónum í blóði (eggbúsörvandi hormón, inhibin B og testosteron) og mati á sæði (sæðisfrumufjöldi, hreyfanleiki og form) við altæka útsetningu sem var u.þ.b.
English: Each 240 mg dose (12 mL vial) of this medicinal product contains 1800 mg hydroxypropylbetadex (cyclodextrin).
Icelandic: Hver 240 mg skammtur (12 ml hettuglas) af lyfinu inniheldur 1.800 mg hydroxypropylbetadex (cyclodextrin).
English: Co-administration of PREVYMIS and thioridazine is not recommended.
Icelandic: Gjöf PREVYMIS samhliða thioridazini er ekki ráðlögð.
English: In rabbits, maternal toxicity (including mortality and abortions) was noted at 225 mg/kg/day (approximately 2-fold the AUC at the RHD); in the offspring, an increased incidence of malformations and variations in the vertebrae and ribs were observed.
Icelandic: Hjá kanínum kom eiturverkun á móður (þ.m.t. dauðsfall og fósturlát) fram við 225 mg/kg/sólarhring (u.þ.b. 2-falt AUC við ráðlagða skammta hjá mönnum); aukin tíðni vanskapana og frávik í hrygg og rifbeinum kom fram hjá afkvæmum.
English: Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with “591” on one side and MSD logo on the other side.
Icelandic: Gul sporöskjulaga tafla 16,5 mm x 8,5 mm að stærð með „591“ á annarri hliðinni og kennimerki MSD á hinni hliðinni.
English: Medicinal products mainly eliminated through metabolism or influenced by active transport Letermovir is a general inducer in vivo of enzymes and transporters.
Icelandic: Lyf þar sem brotthvarf verður aðallega með umbroti eða vegna virks flutnings Letermovir er almennur virkir á ensím og ferjur in vivo.
English: What PREVYMIS looks like and contents of the pack PREVYMIS 240 mg and 480 mg concentrate for solution for infusion is a clear, colourless liquid.
Icelandic: Lýsing á útliti PREVYMIS og pakkningastærðir PREVYMIS 240 mg og 480 mg innrennslisþykkni, lausn er tær litlaus vökvi.
English: Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Icelandic: Örkristallaður sellulósi (E460), natríumkroskarmellósi (E468), povidon (E1201), vatnsfrí kísilkvoða (E551), magnesíumsterat (E470b).
English: In male rats, reduced sperm concentration, reduced sperm motility, and decreased fertility were observed at systemic exposures ≥ 3-fold the AUC in humans at the RHD (see General toxicology).
Icelandic: Hjá karlrottum kom minnkuð sæðisþéttni, minnkaður hreyfanleiki sæðisfruma og minnkuð frjósemi fram við altæka útsetningu sem var ≥3-falt AUC hjá mönnum við ráðlagða skammta (sjá Almenn eiturverkun).
English: Co-administration of PREVYMIS and rifampicin is not recommended.
Icelandic: Gjöf PREVYMIS samhliða rifampicini er ekki ráðlögð.
English: FAS=Full analysis set; FAS includes randomised subjects who received at least one dose of study medicine, and excludes subjects with detectable CMV DNA at baseline.
Icelandic: Greining á heildarþýði (FAS=Full analysis set) felur í sér slembivalda þátttakendur sem fengu minnst einn skammt af rannsóknarlyfinu og útilokar þá sem eru með greinanlegt CMV DNA við upphaf.
English: If PREVYMIS is coadministered with cyclosporine (a potent OATP1B1/3 inhibitor), the recommended dose of PREVYMIS is 240 mg once daily (see Table 1 and sections 4.2 and 5.2).
Icelandic: Ef PREVYMIS er gefið samhliða cyclosporini (öflugur OATP1B1/3 hemill) er ráðlagður skammtur af PREVYMIS 240 mg einu sinni á dag (sjá töflu 1 og kafla 4.2 og 5.2).
English: Frequent monitoring of cyclosporine whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of cyclosporine adjusted accordingly cyclosporine (200 mg single dose)/ letermovir (240 mg daily)
Icelandic: Fylgjast á með þéttni cyclosporins í heilblóði, með tíðum og reglubundnum hætti, meðan á meðferð stendur, þegar íkomuleið PREVYMIS er breytt og þegar gjöf PREVYMIS er hætt og aðlaga skammt cyclosporins í samræmi við það cyclosporin (200 mg stakur skammtur)/ letermovir (240 mg daglega)
English: The mechanism is likely saturation/autoinhibition of OATP1B1/3.
Icelandic: Verkunarhátturinn er líklega mettun/eigin hömlun á OATP1B1/3.
English: The 480 mg tablets are packaged into a carton containing four (4) cardboard cards, each containing a 7-count Polyamide/Aluminium/PVC - Aluminium blister card for a total of 28 tablets.
Icelandic: 480 mg töflur eru í öskju með fjórum (4) spjöldum úr pappa, hvert með polyamid/ál/PVC - álþynnu með 7 töflum, alls 28 töflur.
English: Concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated (see section 4.5).
Icelandic: Ekki á að nota dabigatran, atorvastatin, simvastatin, rosuvastatin eða pitavastatin samhliða (sjá kafla 4.5).
English: If concomitant administration is necessary, TDM for voriconazole is recommended the first 2 weeks after initiating or ending letermovir, as well as after changing route of administration of letermovir or immunosuppressant.
Icelandic: Ef samhliða gjöf er nauðsynleg, er eftirlit með þéttni voriconazols ráðlagt fyrstu 2 vikurnar eftir að gjöf letermovirs er hafin eða henni hætt, sem og eftir breytingu á íkomuleið letermovirs eða ónæmisbælandi lyfs .
English: Administration of PREVYMIS may result in a clinically relevant increase in plasma concentrations of co-administered medicinal products that are OATP1B1/3 substrates.
Icelandic: Gjöf PREVYMIS getur haft í för með sér klínískt marktæka aukningu á plasmaþéttni lyfja sem gefin eru samhliða og eru hvarfefni OATP1B1/3.
English: PREVYMIS should be administered as an intravenous (IV) infusion only.
Icelandic: PREVYMIS er eingöngu gefið með innrennsli í bláæð (i.v.).
English: PREVYMIS 480 mg concentrate for solution for infusion Each vial contains 480 mg (24 mL per vial) of letermovir.
Icelandic: PREVYMIS 480 mg innrennslisþykkni, lausn Hvert hettuglas inniheldur 480 mg (24 ml í hettuglasi) af letermoviri.
English: The median age was 54 years (range: 18 to 78 years); 56
Icelandic: Miðgildisaldur var 54 ár (á bilinu:
English: Each 240 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Icelandic: Hver 240 mg filmuhúðuð tafla inniheldur minna en 1 mmól af natríum (23 mg).
English: No dose recommendation can be made for patients with end stage renal disease (ESRD) with or without dialysis.
Icelandic: Ekki er hægt að ráðleggja skammta hjá sjúklingum með nýrnasjúkdóm á lokastigi með eða án himnuskilunar.
English: • omeprazole, pantoprazole - for stomach ulcers and other stomach problems
Icelandic: • omeprazol, pantoprazol - við magasári og öðrum magavandamálum
English: Stratum-adjusted treatment difference (Letermovir
Icelandic: Meðferðarmunur aðlagaður að lagskiptingu (letermovir-lyfleysa)
English: The process involves the hepatic uptake transporters OATP1B1 and 3 followed by UGT1A1/3 catalysed glucuronidation.
Icelandic: Ferlið er með þátttöku lifrarupptökuferjanna OATP1B1 og 3 og glucurontengingu í kjölfarið sem hvött er af UGT1A1/3.
English: • Compatible medicinal products are listed below.
Icelandic: Samrýmanleg lyf eru talin upp hér á eftir.
English: The size of the induction effect is dependent on letermovir route of administration and whether cyclosporine is concomitantly used.
Icelandic: Umfang virkjunar er háð íkomuleið letermovirs og hvort cyclosporin sé notað samhliða.
English: Expected: ↓ warfarin
Icelandic: ↓ warfarin
English: Letermovir is an inhibitor of OATP1B1/3 transporters.
Icelandic: Letermovir er hemill OATP1B1/3 ferja.
English: The most commonly reported adverse reactions occurring in at least 1% of subjects in the PREVYMIS group and at a frequency greater than placebo were: nausea (7.2%), diarrhoea (2.4%), and vomiting
Icelandic: PREVYMIS og þar sem tíðnin var meiri en fyrir lyfleysu voru: ógleði (7,2%), niðurgangur (2,4%) og uppköst (1,9%).
English: Each 240 mg dose (12 mL vial) of this medicine contains 1800 mg cyclodextrin.
Icelandic: Hver 240 mg skammtur (12 ml hettuglas) lyfsins inniheldur 1.800 mg cyclodextrin.
English: • Ceftriaxone sodium
Icelandic: Ceftriaxonnatríum
English: Each 240 mg film-coated tablet contains 4 mg of lactose (as monohydrate).
Icelandic: Hver 240 mg filmuhúðuð tafla inniheldur 4 mg laktósa (sem einhýdrat).
English: PO:
Icelandic: NN:
English: The 240 mg tablets are packaged into a carton containing four (4) cardboard cards, each containing a 7-count Polyamide/Aluminium/PVC - Aluminium blister card for a total of 28 tablets.
Icelandic: 240 mg töflur eru í öskju með fjórum (4) spjöldum úr pappa, hvert með polyamid/ál/PVC - álþynnu með 7 töflum, alls 28 töflur.
English: There was no testicular toxicity in rats at exposures (AUC) similar to the exposures in humans at the RHD.
Icelandic: Engin eiturverkun var á eistu hjá rottum við útsetningu (AUC) sem var svipuð útsetningu hjá mönnum við ráðlagða skammta.
English: Therefore, the plasma concentrations of medicinal products that are substrates of these enzymes or transporters may increase or decrease when co-administered with letermovir.
Icelandic: Þess vegna getur plasmaþéttni lyfja, sem eru hvarfefni þessara ensíma eða ferja, aukist eða minnkað við samhliða gjöf letermovirs.
English: If you are on a low sodium diet, talk to your doctor before you are given this medicine.
Icelandic: Ef þú ert á saltskertu fæði skaltu hafa samband við lækninn áður en lyfið er gefið.
English: Testicular toxicity was not observed in mice and monkeys at the highest doses tested at exposures up to 4-fold and 2-fold, respectively, the exposures in humans at the RHD.
Icelandic: Eiturverkun á eistu kom ekki fram hjá músum og öpum við stærstu skammta sem voru prófaðir, með allt að 4-falda útsetningu hjá músum og 2-falda útsetningu hjá öpum, miðað við útsetningu hjá mönnum við ráðlagða skammta.
English: • abnormalities in laboratory tests of liver function
Icelandic: óeðlilegar niðurstöður lifrarprófa
English: ↔mycophenolic acid AUC 1.08 (0.97, 1.20) Cmax 0.96 (0.82, 1.12)
Icelandic: ↔mycophenolic sýra AUC 1,08 (0,97; 1,20) Cmax 0,96 (0,82; 1,12)
English: This will give the medicine the best chance to keep you from becoming ill from CMV after you get a bone marrow transplant.
Icelandic: Þannig eru mestar líkur á að koma í veg fyrir veikindi af völdum CMV eftir beinmergsígræðslu.
English: voriconazole (200 mg twice daily)/ letermovir (480 mg daily)
Icelandic: voriconazol (200 mg tvisvar á dag)/ letermovir (480 mg daglega)
English: (Sum of OATP1B1/3 and/or Pgp inhibition and P-gp/UGT induction)
Icelandic: (Summa OATP1B1/3 og/eða P-gp hömlunar og P-gp/UGT virkjunar)
English: mycophenolate mofetil (1 g single dose)/ letermovir (480 mg daily)
Icelandic: mycophenolat mofetil (1 g stakur skammtur)/ letermovir (480 mg daglega)
English: Subjects received CMV DNA monitoring weekly until post-transplant week 14 and then bi-weekly until post-transplant week 24, with initiation of standard-of-care CMV pre-emptive therapy if CMV DNAemia was considered clinically significant.
Icelandic: 14 eftir ígræðslu og síðan aðra hverja viku fram að viku 24 eftir ígræðslu og hefðbundin, CMV hindrandi meðferð við sjúkdómnum (pre-emptive therapy (PET)) hafin ef CMV DNA í blóði var talið klínískt marktækt.
English: PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Icelandic: PREVYMIS er ætlað til að fyrirbyggja endurvirkjun cytomegaloveiru (CMV) og sjúkdóm hjá CMV sermisjákvæðum
English: In HSCT recipients, letermovir AUC was estimated using population pharmacokinetic analyses using Phase 3 data (see Table 4).
Icelandic: Hjá þeim sem fengu blóðmyndandi stofnfrumuígræðslu var AUC fyrir letermovir metið með greiningu á lyfjahvörfum með upplýsingum úr 3. stigs klínískum rannsóknum (sjá töflu 4).
English: Do not break, crush, or chew the tablet.
Icelandic: Ekki má skipta töflunni, mylja hana eða tyggja.
English: Close clinical monitoring should be exercised during administration of PREVYMIS with quinidine.
Icelandic: Viðhafa á náið eftirlit með sjúklingi við samhliða gjöf PREVYMIS og quinidins.
English: Compatible intravenous bags and infusion set materials PREVYMIS is compatible with the following intravenous bags and infusion set materials.
Icelandic: Samrýmanleg efni í innrennslispokum og innrennslissettum PREVYMIS er samrýmanlegt efnum í eftirfarandi innrennslispokum og innrennslissettum.
English: Pimozide and ergot alkaloids are contraindicated (see section 4.3).
Icelandic: Ekki má nota pimozid og ergotalkalóíða (sjá kafla 4.3).
English: Co-administration of PREVYMIS with oral midazolam (a CYP3A substrate) results in 2-3-fold increased midazolam plasma concentrations.
Icelandic: Samhliða gjöf PREVYMIS og midazolams (hvarfefni CYP3A) til inntöku eykur þéttni midazolams í plasma 2-3-falt.
English: (CYP2C9 induction)
Icelandic: (CYP2C9 virkjun)
English: PREVYMIS 240 mg concentrate for solution for infusion contains 23 mg (or 1.0 mmol) sodium per dose.
Icelandic: PREVYMIS 240 mg innrennslisþykkni, lausn inniheldur 23 mg (eða 1,0 mmól) natríum í skammti.
English: (600 mg once daily PO (24 hours after rifampicin)) letermovir (480 mg once daily PO)
Icelandic: (600 mg einu sinni á dag til inntöku (24 klst. eftir rifampicin)) letermovir (480 mg einu sinni á dag til inntöku)
English: PREVYMIS 240 mg concentrate for solution for infusion Each vial contains 240 mg (12 mL per vial) of letermovir.
Icelandic: PREVYMIS 240 mg innrennslisþykkni, lausn Hvert hettuglas inniheldur 240 mg (12 ml í hettuglasi) af letermoviri.
English: PREVYMIS 240 mg film-coated tablet is a yellow oval tablet, debossed with “591” on one side and MSD logo on the other side.
Icelandic: PREVYMIS 240 mg filmuhúðuð tafla er gul sporöskjulaga með „591“ á annarri hliðinni og MSD kennimerki á hinni hliðinni.
English: Table 1: Interactions and dose recommendations with other medicinal products.
Icelandic: Milliverkanir og skammtaleiðbeiningar með öðrum lyfjum.
English: You will get PREVYMIS as an infusion (drip) into a vein and it will take about 1 hour.
Icelandic: PREVYMIS er gefið með innrennsli (dreypi) í bláæð á um það bil 1 klst.
English: -Examples of medicinal products that are metabolised by CYP2B6 include bupropion.
Icelandic: - Dæmi um lyf sem eru umbrotin fyrir tilstilli CYP2B6 er m.a. bupropion.
English: There is no experience with human overdose with PREVYMIS.
Icelandic: Engin reynsla er af ofskömmtun PREVYMIS hjá mönnum.
English: Letermovir affects the formation of proper unit length genomes and interferes with virion maturation.
Icelandic: Letermovir hefur áhrif á myndun genamengja í hæfilegri lengd og truflar þroska veirueinda.
English: 240 mg IV, with cyclosporine
Icelandic: 240 mg til inntöku, með cyclosporini
English: • Pantoprazole sodium
Icelandic: Pantoprazol natríum
English: Conditioning Regimen Myeloablative (n=154, 85)
Icelandic: Undirbúningsmeðferð Beinmergseyðandi meðferð (n=154, 85)
English: Immunosuppressants cyclosporine (50 mg single dose)/ letermovir (240 mg daily)
Icelandic: Ónæmisbælandi lyf cyclosporin (50 mg stakur skammtur)/ letermovir (240 mg daglega)
English: Other medicines and PREVYMIS
Icelandic: Notkun annarra lyfja samhliða PREVYMIS
English: When PREVYMIS is co-administered with cyclosporine, the magnitude of the increase in concentrations of sirolimus may be greater than with PREVYMIS alone.
Icelandic: Þegar PREVYMIS er gefið samhliða cyclosporini getur umfang þéttniaukningar sirolimus verið meiri en við gjöf samhliða PREVYMIS einu og sér.
English: Each carton contains four (4) cardboard, each containing a 7-count blister card for a total of 28 tablets.
Icelandic: Hver askja inniheldur fjögur (4) spjöld úr pappa, hvert með 7 töflum, alls 28 töflur.
English: Factors associated with CMV DNAemia after Week 14 post-transplant among letermovir-treated subjects included high risk for CMV reactivation at baseline, GVHD, use of corticosteroids, and CMV negative donor serostatus.
Icelandic: Þættir sem tengjast CMV DNA í blóði eftir viku 14 eftir ígræðslu hjá þeim sem fengu letermovir eru m.a. mikil hætta á CMV endurvirkjun við upphaf, hýsilsótt, notkun barkstera og CMV sermisneikvætt próf hjá líffæragjafa.
English: Each film-coated tablet contains 240 mg letermovir or 480 mg letermovir.
Icelandic: Hver filmuhúðuð tafla inniheldur 240 mg letermovir eða 480 mg letermovir.
English: Irreversible testicular toxicity was noted only in rats at systemic exposures (AUC) ≥3-fold the exposures in humans at the recommended human dose (RHD).
Icelandic: Óafturkræf eiturverkun á eistu kom aðeins fram hjá rottum við altæka útsetningu (AUC) sem var ≥3-föld útsetning hjá mönnum við ráðlagða skammta fyrir menn.
English: Inducers of drug metabolizing enzymes or transporters Co-administration of PREVYMIS (with or without cyclosporine) with strong and moderate inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended, as it may lead to subtherapeutic letermovir exposure (see Table 1).
Icelandic: Gjöf PREVYMIS (með eða án cyclosporins) samhliða öflugum og meðalöflugum virkjum ferja (t.d. P-gp) og/eða ensíma (t.d. UGT) er ekki ráðlögð þar sem það getur valdið því að útsetning fyrir letermoviri verði undir meðferðargildum (sjá töflu 1).
English: Co-administration of PREVYMIS and nevirapine is not recommended.
Icelandic: Gjöf PREVYMIS samhliða nevirapini er ekki ráðlögð.
English: Letermovir may decrease the plasma concentrations of phenytoin.
Icelandic: Letermovir getur dregið úr plasmaþéttni phenytoins.
English: PREVYMIS 480 mg film-coated tablet is a pink oval, bi-convex tablet, debossed with “595” on one side and MSD logo on the other side.
Icelandic: PREVYMIS 480 mg filmuhúðuð tafla er bleik sporöskjulaga tvíkúpt með „595” á annarri hliðinni og MSD kennimerki á hinni hliðinni.
English: Letermovir may increase the plasma concentrations of glyburide.
Icelandic: Letermovir getur aukið plasmaþéttni glyburids.
English: The categories of failure are mutually exclusive and based on the hierarchy of categories in the order listed.
Icelandic: Flokkar meðferðarbrests útiloka hvern annan og eru í samræmi við stigskiptingu flokkanna eftir upptalningu í töflunni.
English: Cardiovascular medicinal products digoxin (0.5 mg single dose)/ letermovir (240 mg twice daily)
Icelandic: Hjarta- og æðalyf digoxin (0,5 mg stakur skammtur)/ letermovir (240 mg tvisvar á dag)
English: Co-administration of PREVYMIS and phenytoin is not recommended.
Icelandic: Gjöf PREVYMIS samhliða phenytoini er ekki ráðlögð.