FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX09
Icelandic: Veiruhamlandi lyf til altækrar notkunar, önnur veirusýkingalyf, ATC-flokkur:
English: 300 mg twice daily
Icelandic: 300 mg tvisvar á dag
English: Studies in Treatment-Experienced Adult Patients Infected with Non-CCR5-tropic Virus
Icelandic: Rannsóknir á meðferðarreyndum fullorðnum sjúklingum sýktum af veirum sem ekki hafa CCR5-sækni:
English: Carton for bottle containing 25 mg maraviroc film-coated tablets
Icelandic: YTRI UMBÚÐUM Askja fyrir glas sem inniheldur 25 mg maraviroc filmuhúðaðar töflur
English: Each film-coated tablet contains 25 mg of maraviroc.
Icelandic: Hver filmuhúðuð tafla inniheldur 25 mg af maraviroci.
English: The discard date of the oral solution should be written on the carton in the space provided.
Icelandic: Skráið dagsetninguna þegar farga skal mixtúrunni, lausninni á öskjuna í reitinn sem er ætlaður fyrir það.
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with efavirenz and a PI (except tipranavir/ritonavir where the dose should be 600 mg twice daily).
Icelandic: CELSENTRI skammtinn skal minnka í 150 mg tvisvar á sólarhring þegar gefið samtímis efavírenzi og próteasahemli (að undanskildu típranavíri/rítónavíri þar sem skammturinn skal vera 600 mg tvisvar á sólarhring).
English:  lung infection  fungal infection of the gullet (oesophagus)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Table 4 shows the incidence ≥1% of Grade 3-4 Abnormalities (ACTG Criteria) based on the maximum shift in laboratory test values without regard to baseline values.
Icelandic: 3-4 (ACTG-skilmerki) byggt á hámarksbreytingu á rannsóknaniðurstöðum án tillits til upphafsgilda.
English: NNRTI + PI Efavirenz 600 mg QD + lopinavir/ritonavir 400mg/100 mg BID (maraviroc 300 mg BID)
Icelandic: Bakritahemlar sem ekki eru núkleósíð (NNRTI) + próteasahemlar (PI) Efavírenz 600 mg einu sinni á sólarhring + lópínavír/rítónavír 400mg/100 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: • diarrhoea, feeling sick, stomach ache, wind (flatulence),
Icelandic: • niðurgangur, ógleði, kviðverkir, uppþemba, vindgangur
English: • fever (high temperature).
Icelandic: • hiti (hár hiti)
English: Efavirenz 600 mg QD + saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID)
Icelandic: Efavírenz 600 mg einu sinni á sólarhring + sakvínavír/rítónavír 1000 mg/100 mg tvisvar á sólarhring (maraviroc 100 mg tvisvar á sólarhring)
English: In mice and human beings that lack CCR5 receptors through genetic deletion, no significant adverse consequences have been reported.
Icelandic: Ekki hefur verið greint frá marktækum neikvæðum afleiðingum hjá músum og mönnum sem skortir CCR5-viðtaka eftir erfðaúrfellingu.
English: CELSENTRI 20 mg/ml oral solution
Icelandic: HEITI LYFS CELSENTRI 20 mg/ml mixtúra. lausn.
English: celsentri 150 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI celsentri 150 mg
English: CELSENTRI 300 mg twice daily and digoxin can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og digoxín má gefa samtímis án skammtaaðlögunar.
English: At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL (range 2.4 to 6.2 log10
Icelandic: RNA í plasma 4,3 log10 eintök/ml (bil 2,4 til 6,2 log10 eintök á ml), meðal CD4+ frumufjöldi var 551 frumur/mm
English: Symptoms may include:  muscle weakness  weakness beginning in the hands and feet and moving up towards the trunk of the body  palpitations or tremor  hyperactivity (excessive restlessness and movement).
Icelandic: máttleysi sem kemur fyrst fram í höndum og fótum og færist upp eftir líkamanum í átt að bolnum
English: When used with other antiretroviral medicinal products in cell culture, the combination of maraviroc was not antagonistic with a range of NRTIs, NNRTIs, PIs or the HIV fusion inhibitor enfuvirtide.
Icelandic: Samsett meðferð með maraviroci og öðrum retróveirulyfjum í frumurækt, var ekki mótverkandi við fjölda núkleósíðabakritahemla, bakritahemla sem ekki eru núkleósíð, próteasahemla eða HIVinngönguhemilinn, enfúvirtíð.
English: Infections and infestations
Icelandic: blöðrur og flögnun
English: Overall, the mechanisms of resistance to maraviroc observed in this treatment-experienced paediatric population were similar to those observed in adult populations.
Icelandic: Í heildina var verkunarháttur ónæmis fyrir maraviroci sem sást hjá þessu meðferðarreynda þýði með börnum, svipað og það sem sást hjá þýði með fullorðnum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM Askja fyrir þynnupakkningar.
English: OTHER
Icelandic: Inniheldur
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
Icelandic: LYFJAFORM OG INNIHALD 90 filmuhúðaðar töflur
English: Saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID)
Icelandic: Sakvínavír/rítónavír 1000 mg/100 mg tvisvar á sólarhring (maraviroc 100 mg tvisvar á sólarhring)
English: ANTIFUNGALS
Icelandic: Nelfínavír
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”.
Icelandic: Bláar, tvíkúptar, sporöskjulaga, filmuhúðaðar töflur, u.þ.b. 4,6 mm x 8,0 mm að stærð og merktar „MVC 25“.
English: However, no clinically significant QT prolongation compared to placebo + OBT was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of maraviroc to prolong the QT interval.
Icelandic: stigs klínískum rannsóknum þar sem gefinn var ráðlagður skammtur af maraviroci eða í sérstakri lyfjahvarfarannsókn til að meta hugsanleg áhrif maravirocs á lengingu QT-bils, samanborið við lyfleysu + bestu grunnmeðferð.
English: Rare side effects These may affect up to 1 in 1,000 people:
Icelandic: Þær geta komið fyrir hjá 1 af 1.000 einstaklingum:
English: Carton for bottle containing 20 mg/ml maraviroc oral solution
Icelandic: YTRI UMBÚÐUM Askja fyrir glas sem inniheldur 20 mg/ml maraviroc mixtúru, lausn
English: 120 film-coated tablets
Icelandic: 60 filmuhúðaðar töflur
English: Each film-coated tablet contains 150 mg of maraviroc.
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg af maraviroci.
English: Atazanavir/ritonavir concentrations not measured, no effect is expected.
Icelandic: Þéttni atazanavírs/rítónavíra ekki mæld, engra áhrifa að vænta.
English: The clinical efficacy of maraviroc (in combination with other antiretroviral medicinal products) on plasma HIV RNA levels and CD4+ cell counts have been investigated in two pivotal randomized, double blind, multicentre studies (MOTIVATE 1 and MOTIVATE 2, n=1076) in patients infected with CCR5 tropic HIV-1 as determined by the Monogram Trofile Assay.
Icelandic: Rannsóknirnar eru slembiraðaðar, tvíblindar, fjölsetra rannsóknir (MOTIVATE 1 og MOTIVATE 2, n=1076) á sjúklingum sem eru sýktir af CCR5-sæknum HIV-1, ákveðið með Monogram Trofile prófi.
English: Failure with CCR5-tropic virus
Icelandic: Meðferðarbrestur með CCR5-sæknum veirum:
English: Poly (vinyl alcohol) Titanium dioxide (E171) Macrogol 3350
Icelandic: Títantvíoxíð (E171)
English: • skin rash or itching
Icelandic: • húðútbrot eða kláði
English: Lopinavir/ritonavir concentrations not measured, no effect is expected.
Icelandic: Þéttni lópínavírs/rítónavírs ekki mæld, engra áhrifa að vænta
English: Fosamprenavir/ritonavir 700 mg/100 mg BID (maraviroc 300 mg BID)
Icelandic: Fosamprenavír/rítónavír 700 mg/100 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: Percentage of patients with HIV-1 RNA <50 copies/mL
Icelandic: RNA <50 eintök/ml
English:  problems with your heart or circulatory system.
Icelandic: • hjartasjúkdóma eða blóðrásarsjúkdóma.
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with ketoconazole.
Icelandic: CELSENTRI skammtinn skal minnka í 150 mg tvisvar á sólarhring þegar gefið samtímis ketókónazóli.
English: Hepatic failure with allergic features very rare
Icelandic: Lifrarbilun með ofnæmiseinkennum koma örsjaldan fyrir
English: Maraviroc 300 mg twice daily + OBT
Icelandic: Maraviroc 300 mg tvisvar á sólarhring + besta grunnmeðferð
English: Turn the bottle upside down.
Icelandic: 4. Snúðu glasinu á hvolf.
English: Cardiovascular safety
Icelandic: Heildarbílírúbín
English: Rifampicin concentrations not measured, no effect expected.
Icelandic: Atazanavír þéttni ekki mæld, engra áhrifa að vænta.
English: Median peak maraviroc plasma concentrations are attained at 2 hours (range 0.5-4 hours) following single oral doses of 300 mg commercial tablet administered to healthy volunteers.
Icelandic: (á bilinu 0,5-4 klst.) eftir inntöku 300 mg töflu hjá heilbrigðum sjálfboðaliðum.
English: Genotypic resistance
Icelandic: öndunarerfiðleika
English: Itraconazole
Icelandic: JURTALYF
English: Joint pain, stiffness and bone problems
Icelandic: • liðverkir, stífleiki og beinkvillar
English: In a Phase 1 study conducted in healthy subjects, Blacks with a CYP3A5 genotype conferring extensive maraviroc metabolism (2 CYP3A5*1 alleles; n=12) had a 37% and 26% lower AUC when dosed with maraviroc 300 mg twice daily compared with Black (n=11) and Caucasian (n=12) subjects with CYP3A5 genotype conferring poor maraviroc metabolism (no CYP3A5*1 allele), respectively.
Icelandic: Í I. stigs rannsókn sem gerð var hjá heilbrigðum einstaklingum höfðu svartir með CYP3A5 arfgerð sem svaraði til hraðs umbrots maravirocs (2 CYP3A5*1 samsætur; n=12) 37% lægra AUC við gjöf maraviroc
English: Nelfinavir
Icelandic: lungnasýking
English: CELSENTRI 300 mg film-coated tablets maraviroc
Icelandic: CELSENTRI 300 mg filmuhúðaðar töflur maraviroc
English: 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Icelandic: 6 LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English:  old, hidden infections flaring up again as the body fights them  the immune system attacking healthy body tissue (autoimmune disorders).
Icelandic: • gamalla, dulinna sýkinga sem rjúka upp aftur þegar líkaminn berst við þær
English: Lopinavir/ritonavir 400 mg/100 mg BID (maraviroc 300 mg BID)
Icelandic: Lópínavír/rítónavír 400 mg/100 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: Cases of syncope caused by postural hypotension have been reported.
Icelandic: Greint hefur verið frá tilvikum um yfirlið af völdum réttstöðuþrýstingsfalls.
English: In vitro studies indicate that CYP3A4 is the major enzyme responsible for maraviroc metabolism.
Icelandic: In vitro rannsóknir benda til að maraviroc umbrotni aðallega fyrir tilstilli CYP3A4-ensímsins.
English: Lot {number}
Icelandic: 13. LOTUNÚMER Lot {number}
English: Hepatic disease
Icelandic: • nýrnasjúkdóma.
English: Demographic and Baseline Characteristics
Icelandic: Lýðfræðileg einkenni og einkenni í upphafi
English: Lipase
Icelandic: Leitni
English: Etravirine 200 mg BID (maraviroc 300 mg BID)
Icelandic: Etravirín 200 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: CELSENTRI 300 mg twice daily and raltegravir can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og raltegravír má gefa samtímis án skammtaaðlögunar.
English: CELSENTRI dose should be increased to 600 mg twice daily when co-administered with efavirenz in the absence of a potent CYP3A4 inhibitor.
Icelandic: CELSENTRI skammt ætti að auka í 600 mg tvisvar á sólarhring þegar það er gefið samtímis efavírenzi án öflugs CYP3A4- hemils.
English: CELSENTRI dose should be increased to 600 mg twice daily when co-administered with rifampicin in the absence of a potent CYP3A4 inhibitor.
Icelandic: CELSENTRI skammtinn skal auka í 600 mg tvisvar á sólarhring þegar gefið samtímis rífampisíni án öflugs CYP3A4-hemlis.
English: Table 1 Recommended dosing regimen in children aged 2 years and above and weighing at least 10 kg
Icelandic: Tafla 1 Ráðlagðir skammtar fyrir börn á aldrinum 2 ára og eldri sem eru a.m.k.
English: For combination with efavirenz + PI, see separate recommendations below.
Icelandic: Um samsetta meðferð með efavírenzi + próteasahemlum, sjá sérstakar ráðleggingar hér á eftir.
English: Contains soya lecithin: see leaflet for further information.
Icelandic: Sjá nánari upplýsingar í fylgiseðli.
English: Concomitant Medications
Icelandic: Samhliða lyfjagjöf
English: Celsentri 150 mg film-coated tablets maraviroc
Icelandic: CELSENTRI 150 mg filmuhúðaðar töflur maraviroc
English: A study compared the pharmacokinetics of a single 300 mg dose of maraviroc in subjects with severe renal impairment (CLcr < 30 mL/min, n=6) and end stage renal disease (ESRD) to healthy volunteers (n=6).
Icelandic: Rannsókn var gerð til að bera saman lyfjahvörf 300 mg stakskammts af maraviroci hjá einstaklingum með alvarlega skerta nýrnastarfsemi (CLcr < 30 ml/mín.
English: Myositis, blood creatine phosphokinase increased uncommon
Icelandic: Vöðvabólga, aukning á kreatínfosfókínasa í blóði sjaldgæfar
English: celsentri 25 mg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI celsentri 25 mg
English: Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Icelandic: Örkristallaður sellulósi, vatnsfrítt kalsíumhýdrógenfosfat, natríumsterkjuglýkolat,
English: Clear, colourless, oral solution.
Icelandic: Tær, litlaus mixtúra, lausn.
English: Table 1.
Icelandic: Tafla 2.
English: CELSENTRI should be used with caution in adult patients with severe renal impairment (CLcr <30 mL/min) who are receiving potent CYP3A4 inhibitors (see sections 4.4 and 5.2).
Icelandic: Gæta skal varúðar við notkun CELSENTRI hjá fullorðnum sjúklingum með alvarlega skerta nýrnastarfsemi (CLcr <30 ml/mín.)
English: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz 600 mg QD (maraviroc 100 mg BID)
Icelandic: Bakritahemlar sem ekki eru núkleósíð (NNRTI) Efavírenz 600 mg einu sinni á sólarhring (maraviroc 100 mg tvisvar á sólarhring)
English: Store below 30 °C.
Icelandic: SÉRSTÖK GEYMSLUSKILYRÐI Geymið við lægri hita en 30°C.
English: Each ml of oral solution contains 20 mg maraviroc
Icelandic: INNIHALDSLÝSING Hver ml inniheldur 20 mg af maraviroci.
English: Saquinavir/ritonavir concentrations not measured, no effect is expected.
Icelandic: Þéttni sakvínavírs/rítónavírs ekki mæld, engra áhrifa að vænta.
English: Tropism
Icelandic: Töflukjarni
English: Soya lecithin
Icelandic: Sojalesitín
English: Cardiac disorders
Icelandic: HJARTSLÁTTARTRUF LUNUM
English: Bottle label - 25 mg film-coated tablets
Icelandic: INNRI UMBÚÐUM Merkimiði á glasi - 25 mg maraviroc filmuhúðaðar töflur
English: Raltegravir C12: ↓ 0.72
Icelandic: Raltegravír C12:
English: Seizures and seizure disorders uncommon
Icelandic: Flog og flogaköst sjaldgæfar
English: Protease Inhibitors (PIs) Atazanavir 400 mg QD (maraviroc 300 mg BID)
Icelandic: Próteasahemlar (PI) Atazanavír 400 mg einu sinni á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: Hepatobiliary disorders
Icelandic: KRAMPALEYSANDI LYF
English: Renal impairment
Icelandic: dökkt þvag
English: Bottle label - 150 mg film-coated tablets
Icelandic: INNRI UMBÚÐUM Merkimiði á glasi - 150 mg maraviroc filmuhúðaðar töflur
English: The use of CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg .
Icelandic: Notkun CELSENTRI hjá börnum yngri en 2 ára eða sem eru léttari en 10 kg hefur ekki verið rannsökuð.
English:  feeling dizzy, faint or light headed when standing up  kidney failure, protein in the urine
Icelandic: sundl, yfirlið eða aðsvif þegar staðið er á fætur
English: Atazanavir/ritonavir 300 mg/100 mg QD (maraviroc 300 mg BID)
Icelandic: Atazanavír/rítónavír 300 mg/100 mg einu sinni á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: SEDATIVES
Icelandic: Skammtar
English: CELSENTRI 300 mg twice daily and methadone can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og metadón má gefa samtímis án skammtaaðlögunar.
English: Efavirenz, lopinavir/ritonavir concentrations not measured, no effect expected.
Icelandic: Þéttni efavírenz, lópínavírs/rítónavírsekki mæld, engra áhrifa að vænta.
English: • The other ingredients are: citric acid (anhydrous), sodium citrate dihydrate, sucralose, sodium benzoate, strawberry flavouring (501440T), purified water
Icelandic: Önnur innihaldsefni eru: sítrónusýra (vatnsfrí), afvatnað natríumsítrat, súkralósi, natríumbenzóat,
English: CELSENTRI 300 mg twice daily and statins can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og statín má gefa samtímis án skammtaaðlögunar.
English: Cellulose, microcrystalline Calcium hydrogen phosphate, anhydrous
Icelandic: Vatnsfrítt kalsíumhýdrógenfosfat
English: Maraviroc is the major circulating component (approximately 42% radioactivity) following a single oral dose of 300 mg.
Icelandic: Eftir inntöku staks 300 mg skammts er maraviroc aðalefnið í blóðrásinni (u.þ.b. 42% geislavirkni).
English: Carton for blister pack containing 300 mg maraviroc film-coated tablets
Icelandic: INNRI UMBÚÐUM Merkimiði á glasi - 300 mg maraviroc filmuhúðaðar töflur
English: Immune reconstitution syndrome
Icelandic: Ónæmisendurvirkjunarheilkenni
English: EXP {MM/YYYY}
Icelandic: 3. FYRNINGARDAGSETNING EXP {MM-YYYY }
English: Other possible side effects of combination therapy for HIV
Icelandic: önnur lyf til meðferðar við sýkingum af völdum HIV eða lifrarbólgu
English: If you get any of the following symptoms while you're taking CELSENTRI :  swelling of the face, lips or tongue  difficulty breathing  widespread skin rash  fever (high temperature)  blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
Icelandic: á húð, einkum í kringum munninn, nefið, augun og kynfærin
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and a PI.
Icelandic: CELSENTRI skammtinn skal minnka í 150 mg tvisvar á sólarhring þegar gefið samhliða etraviríni og próteasahemli
English: Efavirenz concentrations not measured, no effect is expected.
Icelandic: Efavírenzþéttni ekki mæld, engra áhrifa að vænta.
English: Tenofovir 300 mg QD (maraviroc 300 mg BID)
Icelandic: Tenófóvír 300 mg einu sinni á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: Phenotypic resistance
Icelandic: á GeneSeq-ónæmisgreiningu
English: CELSENTRI 300 mg twice daily and pegylated interferon can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og pegýlerað interferón má gefa samtímis án skammtaaðlögunar.
English: Ethinylestradiol 30 mcg QD (maraviroc 100 mg BID)
Icelandic: Etinýlestradíól 30 g einu sinni á sólarhring (maraviroc 100 mg tvisvar á sólarhring)
English: from working properly.
Icelandic: EÐA ÚRGANGS VEGNA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Icelandic: Virk ARV í bestu grunnmeðferð
English: CELSENTRI 25 mg film-coated tablets maraviroc
Icelandic: HEITI LYFS CELSENTRI 25 mg filmuhúðaðar töflur maraviroc
English: Citric acid (anhydrous) Sodium citrate dihydrate Sucralose
Icelandic: Sítrónusýra (vatnsfrí) Afvatnað natríumsítrat Súkralósi
English: Maraviroc Cmax: ↑ 2.26
Icelandic: Maraviroc C12:
English: Package leaflet: information for the user CELSENTRI 20 mg /ml oral solution maraviroc
Icelandic: Upplýsingar fyrir notanda lyfsins CELSENTRI 20 mg/ml mixtúra, lasun maraviroc
English: Raltegravir 400 mg BID (maraviroc 300 mg BID)
Icelandic: Raltegravír 400 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: There is limited experience in patients with reduced hepatic function, therefore maraviroc should be used with caution in this population (see sections 4.2 and 5.2).
Icelandic: Því skal gæta varúðar við notkun maravirocs hjá þessum sjúklingahópi (sjá kafla 4.2 og 5.2).
English: Sulphamethoxazole/ Trimethoprim 800 mg/160 mg BID (maraviroc 300 mg BID)
Icelandic: 800 mg/160 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: Efavirenz, saquinavir/ritonavir concentrations not measured, no effect expected.
Icelandic: Þéttni efavírenz, sakvínavírs/rítónavírs ekki mæld, engra áhrifa að vænta.
English: Infomed@viivhealthcare.com
Icelandic: ViiV Healthcare GmbH Tel.:
English: CELSENTRI 300 mg twice daily and levonorgestrel can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og mídazólam má gefa samtímis án skammtaaðlögunar.
English: EU/1/07/418/013
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/418/013
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - maraviroc 20 mg/ml oral solution
Icelandic: INNRI UMBÚÐUM Merkimiði á glasi - 20 mg/ml maraviroc mixtúra, lausn
English: and ethinylestradiol can be co-administered without dose adjustment.
Icelandic: sólarhring og levónorgestrel má gefa samtímis án skammtaaðlögunar.
English: Elvitegravir/ritonavir 150/100mg QD (maraviroc 150 mg BID)
Icelandic: Elvitegravír/rítónavír 150/100 mg einu sinni á sólarhring (maraviroc 150 mg tvisvar á sólarhring)
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with itraconazole.
Icelandic: CELSENTRI skammtinn skal minnka í 150 mg tvisvar á sólarhring þegar gefið samtímis ítrakónazóli.
English: After first opening: 60 days
Icelandic: Eftir fyrstu opnun::
English: EU/1/07/418/011
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/418/011
English: Darunavir/ritonavir 600 mg/100 mg BID (maraviroc 150 mg BID)
Icelandic: Darunavír/rítónavír 600 mg/100 mg tvisvar á sólarhring (maraviroc 150 mg tvisvar á sólarhring)
English: Midazolam 7.5 mg Single Dose (maraviroc 300 mg BID)
Icelandic: RÓANDI LYF Benzódiazepín Mídazólam 7,5 mg stakur skammtur (maraviroc 300 mg tvisvar á sólarhring)
English: People with kidney problems
Icelandic: Einstaklingar með nýrnakvilla
English: CELSENTRI 300 mg twice daily and sulphamethoxazole/ trimethoprim can be co-administered without dose adjustment.
Icelandic: CELSENTRI 300 mg tvisvar á sólarhring og súlfametoxasól/trímetóprím má gefa samtímis án skammtaaðlögunar.
English: CD4+ cell count Mean change from baseline (cells/µL) 1 p-values < 0.0001 2 For all efficacy endpoints the confidence intervals were 95%, except for HIV-1 RNA Change from baseline, which was 97.5%
Icelandic: Hjá öllum endapunktum verkunar voru öryggisbilin 95%, nema fyrir HIV-1-RNA þar sem breyting frá upphafsgildi var
English: Zidovudine 300 mg BID (maraviroc 300 mg BID)
Icelandic: Zídóvúdín 300 mg tvisvar á sólarhring (maraviroc 300 mg tvisvar á sólarhring)
English: EU/1/07/418/012
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/418/012
English: EU/1/07/418/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/418/006
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Icelandic: Þetta á einnig við um náttúrulyf eða önnur lyf sem fengin eru án lyfseðils.
English: The potential risk for humans is unknown.
Icelandic: Möguleg hætta fyrir menn er ekki þekkt.
English: Swallow the capsules one at a time with water.
Icelandic: Gleypið hylkin, eitt í einu, með vatni.
English: The effects of COMETRIQ in people younger than 18 years old are not known.
Icelandic: Áhrif COMETRIQ hjá fólki yngra en 18 ára eru ekki þekkt.
English: Component of a 28 day pack, can't be sold separately.
Icelandic: Hluti 28 daga pakkningar, má ekki selja stakt.
English: The secondary objectives were to compare overall response rate (ORR) and overall survival (OS).
Icelandic: Önnur markmið voru að bera saman heildarsvörunartíðni (overall response rate (ORR) og heildarlifun (overall survival (OS)).
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Icelandic: Látið lækninn strax vita ef einhverjar af eftirtöldum aukaverkunum koma fram - bráð læknismeðferð kann að vera nauðsynleg:
English: The median time to first dose reduction was 43 days, and to first dose interruption was 33 days.
Icelandic: Miðgildi tímans fram að fyrstu skammtaminnkun var 43 dagar og 33 dagar fram að fyrsta hléi á meðferð.
English: Your doctor will determine if you need your dose adjusted, particularly during the first eight weeks of therapy with COMETRIQ.
Icelandic: Læknirinn mun ákveða hvort breyta þarf skammtinum, einkum á fyrstu átta vikum meðferðar með COMETRIQ.