natgillin/translations-raw huggingface dataset:
In case of concomitant antiviral therapy for hepatitis B and/or C, please refer to the relevant product information for these medicinal products.
V primeru sočasnega protivirusnega zdravljenja hepatitisa B in/ali C glejte tudi ustrezne informacije o teh zdravilih.
Some people taking CELSENTRI have developed severe and life-threatening skin reactions and allergic reactions.
Nekaterim ljudem, ki so jemali zdravilo CELSENTRI, so se pojavile hude in življenjsko ogrožajoče kožne reakcije in alergijske reakcije.
No relevant difference between Caucasian, Asian and Black subjects has been observed.
Med belci, azijci in črnci niso opazili pomembne razlike.
The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Simptomi avtoimunskih bolezni se lahko pojavijo veliko mesecev po začetku jemanja zdravila za zdravljenje okužbe z virusom HIV.
The safety and efficacy of maraviroc have not been specifically studied in patients with significant underlying liver disorders.
Varnost in učinkovitost maraviroka nista specifično raziskani pri bolnikih s pomembno osnovno boleznijo jeter.
Therefore, dosing frequencies of longer than 24 hours in subjects with renal impairment may result in inadequate exposures between 24-48 hours.
Če je presledek med odmerki pri bolnikih z okvaro ledvic daljši od 24 ur, se zato lahko v času od 24 do 48 ur pojavi nezadostna izpostavljenost.
The absorption of maraviroc is variable with multiple peaks.
Absorpcija maraviroka je variabilna z mnogimi vrhovi.
Some medicines may change the amount of CELSENTRI in the body when they are taken at the same time as CELSENTRI.
Nekatera zdravila lahko spremenijo količino zdravila CELSENTRI v telesu, če jih vzamete sočasno z zdravilom CELSENTRI.
If you are allergic to peanut or soya do not use this medicinal product.
Če ste alergični na arašide ali sojo, ne uporabljajte tega zdravila.
In mice and human beings that lack CCR5 receptors through genetic deletion, no significant adverse consequences have been reported.
Pri miših ter ljudeh, ki zaradi genske delecije nimajo CCR5 receptorjev, niso poročali o pomembnih neželenih učinkih.
Please also refer to the respective Summary of Product Characteristics of the other antiretroviral medicinal products used in the combination.
Prosimo, glejte tudi ustrezne povzetke glavnih značilnosti zdravila za druga protiretrovirusna zdravila, uporabljena v kombinaciji.
This polar metabolite has no significant pharmacological activity.
Ta polarni presnovek nima pomembnega farmakološkega delovanja.
This subgroup had a high degree of bad prognostic markers, i.e. extensive resistance and high baseline viral loads.
Ta podskupina je imela veliko slabih prognostičnih označevalcev, tj. izdatno odpornost in veliko izhodiščno virusno breme.
Your doctor must take blood samples to test whether CELSENTRI is an appropriate treatment for you (or your child, if they are the patient).
Zdravnik vam mora vzeti kri za preiskave, s katerimi bo ugotovil, ali je zdravilo CELSENTRI za vas primerno zdravilo (ali za vašega otroka, če je bolnik on).
Some people taking medicines for HIV infection develop other conditions, which can be serious.
Nekaterim bolnikom, ki jemljejo zdravila za okužbo s HIV, se pojavijo druga stanja, ki so lahko resna.
No relevant differences in pharmacokinetics have been observed.
Niso opazili pomembnih razlik v farmakokinetiki.
Medicinal product by therapeutic areas (dose of CELSENTRI used in study)
Zdravila po terapevtskih področjih (v študiji uporabljeni odmerek zdravila CELSENTRI)
Other metabolites are products of mono-oxidation and are only minor components of plasma radioactivity.
Drugi presnovki nastanejo z monooksidacijo in so le manj pomembne komponente radioaktivnosti v plazmi.
 Tell your doctor.
Obvestite zdravnika.
Prior to deciding the dose of CELSENTRI by weight, please refer to Table 2 in section 4.5 to carefully determine the corresponding adult dose.
Pred določitvijo odmerka zdravila CELSENTRI glede na telesno maso skrbno preglejte preglednico 2 v poglavju 4.5, da boste natančno določili ustrezen odmerek za odrasle.
• liver problems, including chronic hepatitis B or C. Only a limited number of people with liver problems have taken CELSENTRI.
• težave z jetri, vključno s kroničnim hepatitisom B ali C. Zdravilo CELSENTRI je namreč jemalo le malo bolnikov, ki so imeli težave z jetri.
 old, hidden infections flaring up again as the body fights them  the immune system attacking healthy body tissue (autoimmune disorders).
 stare, prikrite okužbe, ki se znova razplamtijo, ko se telo z njimi bori, ali  napad imunskega sistema na zdrava tkiva lastnega telesa (avtoimunske bolezni).
Number of active ARVs in OBT1:
Število aktivnih PRZ v OOT1:
You (or your child) can still pass on HIV when taking this medicine, although the risk is lowered by effective treatment.
Med jemanjem tega zdravila lahko vi (ali vaš otrok) še vedno prenesete okužbo s HIV na druge, čeprav učinkovito zdravljenje to tveganje zmanjša.
Hold the bottle firmly.
Trdno primite plastenko.
Interaction not studied.
Interakcij niso raziskali.
What CELSENTRI is and what it is used for
Kaj je zdravilo CELSENTRI in za kaj ga uporabljamo
Symptoms of infection and inflammation may develop, caused by either:
Pojavijo se lahko simptomi okužbe in vnetja, ki jih povzročijo ali:
Keep it safely 2.
Varno ga shranite.
The adverse reactions and laboratory abnormalities presented below are not exposure adjusted.
Spodaj navedeni neželeni učinki in laboratorijske nepravilnosti niso prilagojeni glede na izpostavljenost.
The latter group had markers correlating to low compliance (low and variable drug levels and often a calculated high residual sensitivity score of the OBT).
Ta skupina je imela značilnosti, ki ustrezajo nizki komplianci (nizke in spremenljive ravni zdravila ter pogosto izračunana visoka rezidualna občutljivost OOT).
Overall, the safety profile in paediatric patients was similar to that observed in adult clinical studies.
V celoti so bile varnostne značilnosti pri pediatričnih bolnikih podobne kot v kliničnih študijah pri odraslih.
The most significant circulating metabolite in humans is a secondary amine (approximately 22% radioactivity) formed by N-dealkylation.
Najpomembnejši presnovek v obtoku pri človeku je sekundarni amin (približno 22 % radioaktivnosti), ki nastane z N-dealkilacijo.
22.5% Odds ratio: 4.76
22,5 % Razmerje obetov: 4,76
Studies with the tablets demonstrated a reduced foodeffect at higher doses.
Študije s tabletami so pokazale manjši vpliv hrane pri večjih odmerkih.
Angina pectoris rare
Srčne bolezni angina pektoris redki
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Osebe z napredovalo okužbo s HIV (AIDS) imajo oslabel imunski sistem in so bolj nagnjene k pojavu resnih okužb (oportunističnih okužb).
It may not be excluded that maraviroc can increase the exposure to the P-glycoprotein substrate dabigatran etexilate.
Ni mogoče izključiti, da maravirok poveča izpostavljenost substratu P-glikoproteina dabigatran-eteksilatu.
At higher exposure of maraviroc a potential inhibition of CYP2D6 cannot be excluded.
Pri višji izpostavljenosti maraviroku ni mogoče izključiti potencialnega zaviranja CYP2D6.
Children from 2 years of age and weighing at least 10kg The recommended dose of CELSENTRI should be based on body weight (kg) and should not exceed the recommended adult dose.
Otroci, starejši od 2 let in s telesno maso vsaj 10 kg Priporočeni odmerek zdravila CELSENTRI mora temeljiti na telesni masi (kg) in ne sme preseči priporočenega odmerka za odrasle.
The recommended dose of CELSENTRI differs depending on interactions with concomitant antiretroviral therapy and other medicinal products.
Priporočeni odmerek zdravila CELSENTRI se razlikuje glede na medsebojna delovanja s sočasnim protiretrovirusnim zdravljenjem in drugimi zdravili.
Maraviroc is bound (approximately 76%) to human plasma proteins, and shows moderate affinity for albumin and alpha-1 acid glycoprotein.
Maravirok je (približno 76-odstotno) vezan na beljakovine v človeški plazmi in ima zmerno afiniteto za albumin in alfa-1-kisli glikoprotein.
• feeling weak or lack of energy, anaemia (seen in blood test result)
• občutek šibkosti ali pomankanje energije, anemija (pokaže se na preiskavah krvi),
These adverse reactions were common (≥ 1/100 to < 1/10).
Ti neželeni učinki so bili pogosti (≥ 1/100 do < 1/10).
There is limited experience in patients >65 years of age (see section 5.2), therefore CELSENTRI should be used with caution in this population.
Izkušnje pri bolnikih, starejših od 65 let, so omejene (glejte poglavje 5.2), zato je treba pri tej populaciji zdravilo CELSENTRI uporabljati previdno.
Some people taking CELSENTRI have developed serious allergic reactions or skin reactions (see also ‘Serious side effects' in section 4).
Nekaterim osebam, ki so jemale zdravilo CELSENTRI, so se pojavile resne alergijske reakcije ali kožne reakcije (glejte tudi "Resni neželeni učinki" v poglavju 4).
Oral solution Pfizer Service Company Hoge Wei 10
Peroralna raztopina Pfizer Service Company Hoge Wei 10
Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX09
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, druga zdravila za sistemsko zdravljenje virusnih infekcij, oznaka ATC: J05AX09
16.7% Odds ratio: 4.49
16,7 % Razmerje obetov: 4,49
• fever (high temperature).
• povišana telesna temperatura (vročina).
2 What you need to know before you take CELSENTRI Do not take CELSENTRI:
Kaj morate vedeti, preden boste vzeli zdravilo CELSENTRI Ne jemljite zdravila CELSENTRI:
All subjects (n = 103) received maraviroc twice daily and OBT.
Vsi preiskovanci (n = 103) so prejemali maravirok dvakrat na dan in OOT.
• headache, problems sleeping,depression
• glavobol, težave s spanjem, depresija,
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) , or not known (cannot be estimated from the available data).
Pogostnosti so opredeljene kot zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100), redko (≥1/10.000 do <1/1.000) ali neznano (ni mogoče oceniti iz razpoložljivih podatkov).
DRUG ABUSE Methadone
ZLORABA ZDRAVIL Metadon
The gp120 amino acid substitutions identified so far are context dependent and inherently unpredictable with regards to maraviroc susceptibility.
Doslej identificirane substitucije aminokislin gp120 so odvisne od konteksta in so same po sebi nepredvidljive, kar zadeva občutljivost za maravirok.
Clinical status and relevant blood chemistry should be monitored and appropriate symptomatic therapy initiated.
Kontrolirati je treba klinično stanje in pomembne laboratorijske izvide krvi ter uvesti ustrezno simptomatsko zdravljenje.
• drowsiness and confusion
• zaspanost in zmedenost,
It is recommended that mothers infected by HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Priporočljivo je, da ženske okužene z virusom HIV v nobenem primeru ne dojijo, saj s tem preprečijo prenos virusa HIV.
Your doctor will advise you whether it is better to take CELSENTRI oral solution, if you (or your child) are unable to swallow tablets.
Zdravnik vam bo povedal, ali je bolje, da uporabljate peroralno raztopino zdravila CELSENTRI, če vi (ali vaš otrok) ne morete pogoltniti tablet.
Genotypic resistance
Genotipska odpornost
Other possible side effects of combination therapy for HIV
Drugi možni neželeni učinki kombiniranega zdravljenja HIV
Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Bolnikom je treba povedati, da naj se posvetujejo s svojim zdravnikom, če se jim pojavijo bolečine v sklepih, togost sklepov ali težave pri gibanju.
Do not take or give a double dose to make up for a forgotten dose.
Ne vzemite ali dajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
The serum adjusted EC90 value in 43 primary HIV-1 clinical isolates was 0.57 (0.06 - 10.7) ng/mL without significant changes between different subtypes tested.
Za serum prilagojena vrednost EC90 v 43 primarno HIV-1 kliničnih izolatih je bila 0,57 (0,06-10,7) ng/ml, brez bistvenih sprememb med različnimi testiranimi podvrstami.
CELSENTRI contains soya lecithin.
Zdravilo CELSENTRI vsebuje sojin lecitin.
• ritonavir-boosted protease inhibitors (with the exception of tipranavir/ritonavir),
• z ritonavirjem okrepljeni zaviralci proteaz (razen kombinacije tipranavir/ritonavir),
For details please refer to the pharmacology section of the CELSENTRI European Public Assessment Report (EPAR) on the European Medicines Agency (EMA) website.
Za podrobnosti glejte farmakološko poglavje Evropskega javnega poročila o oceni zdravila (EPAR) CELSENTRI, ki je dostopno na spletni strani Evropske agencije za zdravila (EMA).
If a patient is hypersensitive to peanut or soya, CELSENTRI should not be used.
Če je bolnik preobčutljiv za arašide ali sojo, zdravila CELSENTRI ne sme uporabljati.
If you take or give more CELSENTRI than you should
Če ste vzeli ali dali večji odmerek zdravila CELSENTRI, kot bi smeli
Table 2: Interactions and adulta dose recommendations with other medicinal products
Preglednica 2: Medsebojno delovanje in priporočeni odmerki za odraslea skupaj z drugimi zdravili
In rabbit, 7 foetuses had external anomalies at maternally toxic doses and 1 foetus at the mid dose of 75 mg/kg.
Pri kuncih je imelo 7 zarodkov zunanje anomalije pri odmerkih, ki so bili toksični za samico mater, in 1 zarodek pri srednjem odmerku 75 mg/kg.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
• Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
Cases of syncope caused by postural hypotension have been reported.
Poročali so o primerih sinkope povzročene zaradi posturalne hipotenzije.
If a child is unable to reliably swallow CELSENTRI tablets, the oral solution (20 mg per mL) should be prescribed (refer to Summary of Product Characteristics for CELSENTRI oral solution).
Če otrok ne more zanesljivo pogoltniti tablet zdravila CELSENTRI, mu je treba predpisati peroralno raztopino (20 mg/ml) (glejte povzetek glavnih značilnosti zdravila CELSENTRI peroralna raztopina).
Residual activity in vivo for viruses with MPI-values <95% has not been determined.
Preostale in vivo aktivnosti virusov z MPI vrednostmi <95% niso določili.
CELSENTRI works by blocking a receptor called CCR5 which HIV uses to enter and infect your blood cells.
Zdravilo CELSENTRI deluje tako, da blokira receptor CCR5, ki ga virus HIV uporablja za vstopanje v krvne celice in njihovo okužbo.
A randomised, double-blinded study (MERIT), explored maraviroc versus efavirenz, both in combination with zidovudine/lamivudine (n=721, 1:1).
V dvojno slepi randomizirani študiji (MERIT), so raziskovali maravirok v primerjavi z efavirenzom, oba v kominaciji z zidovudinom/lamivudinom (n=721, 1:1).
Doses were given with food on intensive pharmacokinetic evaluation days and optimised to achieve an average concentration over the dosing interval (Cavg) of greater than 100 ng/mL; otherwise, maraviroc was given with or without food.
Bolniki so odmerke na dan intenzivnega vrednotenja farmakokinetike dobili s hrano, optimizirane tako, da je bila med odmernim intervalom dosežena povprečna koncentracija (Cpovp) več kot 100 ng/ml; sicer pa so maravirok jemali s hrano ali brez nje.
Maraviroc was the major component present in urine (mean of 8% dose) and faeces (mean of 25% dose).
Maravirok je bil glavna komponenta v urinu (povprečje 8 % odmerka) in blatu (povprečje 25 % odmerka).
Studies in Adult Patients Co-infected with Hepatitis B and/or Hepatitis C virus
Študije pri odraslih bolnikih, hkrati okuženih z virusom hepatitisa B in/ali hepatitisa C
ViiV Healthcare (logo)
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM ViiV Healthcare (logo)
Population analysis of the Phase 1/2a and Phase 3 studies (16-65 years of age) has been conducted and no effect of age have been observed (see section 4.2).
Izvedli so populacijsko analizo študij 1./2.a faze ter študij 3. faze (16-65 let) ter niso opazili vpliva starosti (glejte poglavje 4.2).
Failure with CCR5-tropic virus
Neuspeh s CCR5-tropnim virusom
• tuberculosis (TB) or serious fungal infections.
• tuberkulozo ali hude glivične okužbe.
Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Čeprav se smatra, da je etiologija multifaktorska (vključuje uporabo kortikosteroidov, uživanje alkohola, hudo imunosupresijo in višji indeks telesne mase), so o primerih osteonekroze poročali predvsem pri bolnikih z napredovalo okužbo s HIV in/ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji (KPRT).
The absolute bioavailability of a 100 mg dose is 23% and is predicted to be 33% at 300 mg. Maraviroc is a substrate for the efflux transporter Pglycoprotein.
Absolutna biološka uporabnost 100 mg odmerka je 23 % in predvidoma 33 % pri 300 mg. Maravirok je substrat P-glikoproteina, efluksnega transporterja.
When maraviroc was administered in studies with healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo.
Ko so maravirok uporabili v študijah pri zdravih prostovoljcih v odmerkih, večjih od priporočenih, so zabeležili primere simptomatske posturalne hipotenzije pogosteje kot pri placebu.
CELSENTRI oral solution (20 mg per mL) formulation should be prescribed if a child is unable to reliably swallow CELSENTRI tablets.
Zdravilo CELSENTRI 20 mg/ml peroralna raztopina je treba predpisati, če otrok ne more zanesljivo pogoltniti tablet zdravila CELSENTRI.
These are rare, and may affect up to 1 in 1,000 people taking CELSENTRI.
Te težave so redke in se lahko pojavijo pri največ 1 od 1.000 oseb, ki jemljejo zdravilo CELSENTRI.
No significant interaction seen/expected.
Pomembno medsebojno delovanje ni ugotovljeno/pričakovano.
The pharmacokinetics of maraviroc is dependent on CYP3A5 activity and expression level, which can be modulated by genetic variation.
Farmakokinetika maraviroka je odvisna od aktivnosti in ravni izraženosti CYP3A5, na kateri lahko vpliva genetska variabilnost.
Mutations were found to accumulate in the gp120 envelope glycoprotein (the viral protein that binds to the CCR5 co-receptor).
Ugotovljeno je bilo kopičenje mutacij v ovojničnem glikoproteinu gp120 (virusna beljakovina, ki se veže na soreceptor CCR5).
Contents of the pack and other information What CELSENTRI contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo CELSENTRI
Studies in humans and in vitro studies using human liver microsomes and expressed enzymes have demonstrated that maraviroc is principally metabolized by the cytochrome P450 system to metabolites that are essentially inactive against HIV-1.
Študije pri človeku ter in vitro študije s človeškimi jetrnimi mikrosomi in eksprimiranimi encimi so pokazale, da se maravirok presnavlja predvsem s sistemom citokroma P450 v presnovke, ki so v bistvu neaktivni proti HIV-1.
Treatment of overdose should consist of general supportive measures including keeping the patient in a supine position, careful assessment of patient vital signs, blood pressure and ECG.
Specifičnega antidota za preveliko odmerjanje maraviroka ni. Zdravljenje prevelikega odmerjanja mora obsegati splošne podporne ukrepe, vključno s tem, da bolnik leži, in natančno oceno bolnikovih vitalnih znakov, krvnega tlaka in EKG.
Population PK studies suggest that a dose adjustment of maraviroc is not required.
Študije populacijske farmakokinetike kažejo, da odmerka maraviroka ni treba prilagajati.
In the Week 48 analysis (N=103), non-CCR5 tropic-virus was detected in 5/23 (22%) subjects at virologic failure.
V analizi podatkov ob 48. tednu (N = 103) so ne-CCR5-tropni virus ob virološkem neodzivu odkrili pri 5/23 (22 %) preiskovancih.
Sparse pharmacokinetics were evaluated in all subjects including the additional 47 subjects receiving potent CYP3A inhibitors that did not take part in the dose-finding stage.
Redka ocena farmakokinetike je bila opravljena pri vseh preiskovancih, vključno z dodatnimi 47 preiskovanci, ki so prejemali močne zaviralce CYP3A in niso sodelovali v fazi določanja odmerka.
Patients should be informed that dizziness has been reported during treatment with maraviroc.
Bolnikom je treba povedati, da je bilo med zdravljenjem z maravirokom zabeleženo pojavljanje omotice.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Poročali so o primerih osteonekroze, predvsem pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo okužbo s HIV ali dolgotrajno izpostavljenostjo kombinirani protiretrovirusni terapiji (KPRT).
The effect of maraviroc on human pregnancy is unknown.
Vpliv maraviroka na nosečnost ni znan.
Studies in animals showed reproductive toxicity at high exposures.
Študije na živalih so pri večji izpostavljenosti pokazale reproduktivno toksičnost.
Table 3: Adverse reactions observed in clinical trials or post-marketing System Organ Class
Preglednica 3: Neželeni učinki, opaženi v kliničnih preskušanjih ali v obdobju trženja Organski sistem
In vitro studies also indicate that polymorphic enzymes CYP2C9, CYP2D6 and CYP2C19 do not contribute significantly to the metabolism of maraviroc.
Študije in vitro tudi kažejo, da polimorfni encimi CYP2C9, CYP2D6 in CYP2C19 ne prispevajo bistveno k presnovi maraviroka.
CELSENTRI must be taken in combination with other medicines to treat HIV.
Zdravilo CELSENTRI morate uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe s HIV.
Placebo + OBT
Placebo + OOT
Maraviroc 300 mg twice daily + OBT was superior to placebo + OBT across all subgroups of patients analysed (see Table 7).
Kombinacija maravirok 300 mg dvakrat na dan + OOT je prekašala placebo + OOT po vseh analiziranih podskupinah bolnikov (glejte preglednico 7).
In paediatric patients with a successful tropism test, dual mixed/CXCR4-tropic virus was detected in around 40% of screening samples (8/27, 30% in 2-6 year-olds, 31/81, 38% in 6-12 year-olds and 41/90, 46% in 12-18 year-olds), underscoring the importance of tropism testing also in the paediatric population.
Pri pediatričnih bolnikih z uspešnim testom tropizma so dualno mešano/CXCR-tropni virus odkrili v približno 40 % vzorcev ob presejanju (8/27; 30 % v starosti od 2-6 let, 31/81; 38 % v starosti od 6-12 let in 41/90; 46 % v starosti 12-18 let); to kaže, kako pomembno je testiranje tropizma tudi v pediatrični populaciji.
In the pivotal studies of treatment-experienced patients coronary heart disease events were more common in patients treated with maraviroc than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up).
V ključnih študijah že zdravljenih bolnikov so bili dogodki koronarne bolezni srca pogostejši pri bolnikih, ki so prejemali maravirok, kot pri tistih, ki so prejemali placebo (11 med 609 bolnikov let v primerjavi z 0 med 111 bolnikov let spremljanja).
BSA (m2)-based bands have been modified to weight (kg)-based bands to simplify dosing and reduce dosing errors (see section 4.2).
Pasove (m2) telesne površine so prilagodili v pasove (kg) telesne mase za poenostavitev odmerjanja in za zmanjšanje napak pri odmerjanju (glejte poglavje 4.2).