natgillin/translations-raw huggingface dataset:
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged uses this protein to enter the cells.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako zdravilo CELSENTRI deluje?
By attaching itself to the protein, maraviroc prevents it from entering the cells.
Maravirok blokira beljakovino CCR5, ki se nahaja na površini celic v telesu, ki je okuženo s HIV.
Maraviroc cannot work when the virus in a blood sample attaches to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.
Maravirok ne more delovati, kadar se virus v vzorcu krvi veže na drugo beljakovino, imenovano CXCR4, ali kadar se lahko veže na oba, CCR5 in CXCR4.
As HIV can only reproduce itself within cells, CELSENTRI, taken in combination with other antiviral medicines, reduces the level of CCR5-tropic HIV in the blood of patients, and keeps it at a low level.
Ker se lahko virus HIV razmnožuje samo v celicah, zdravilo CELSENTRI, če ga jemljemo v kombinaciji z drugimi protivirusnimi zdravili, zmanjša koncentracijo CCR5- tropnega HIV v krvi in jo vzdržuje na nizki ravni.
CELSENTRI does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo CELSENTRI ne ozdravi okužbe s HIV ali AIDS- a, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z AIDS- om.
How has CELSENTRI been studied?
Kako je bilo zdravilo CELSENTRI raziskano?
The effects of CELSENTRI were first tested in experimental models before being studied in humans.
Učinki zdravila CELSENTRI so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
CELSENTRI was studied in two main studies involving a total of 1,076 patients with CCR5-tropic HIV infection.
Zdravilo CELSENTRI so preučevali v dveh glavnih študijah s skupno 1076 bolniki, okuženimi s CCR5- tropnim HIV.
The patients had taken other treatments for HIV for at least six months, but these had stopped working.
Ti bolniki so predhodno jemali druga zdravila za HIV najmanj šest mesecev, vendar so ta prenehala učinkovati.
The effects of CELSENTRI, taken once or twice a day, were compared with those of placebo (a dummy treatment).
Učinke zdravila CELSENTRI, dajanega enkrat ali dvakrat dnevno, so primerjali z učinki placeba.
All of the patients also took ‘ optimised background therapy’ (a combination of other antiviral medicines chosen for each patient as it had the best chances of reducing the levels of HIV in the blood).
Vsak bolnik je prejemal tudi „ optimizirano osnovno terapijo “ (tako kombinacijo drugih protivirusnih zdravil, izbranih za vsakega posameznega bolnika, ki je obetala največjo verjetnost za zmanjšanje koncentracije HIV v krvi).
The main measure of effectiveness was the reduction in the levels of HIV in the blood (viral load) after 24 weeks.
Glavno merilo učinkovitosti je bilo zmanjšanje koncentracije HIV v krvi (virusnega bremena) po 24 tednih.
What benefit has CELSENTRI shown during the studies?
Kakšne koristi je zdravilo CELSENTRI izkazalo med raziskavami?
CELSENTRI was more effective than placebo in reducing viral loads, when taken in combination with optimised background therapy.
Zdravilo CELSENTRI, dajano v kombinaciji z optimizirano osnovno terapijo, je bilo pri zmanjševanju virusnega bremena učinkovitejše od placeba.
Looking at the results of the two studies taken together, viral loads had fallen by an average of 99% after 24 weeks in the patients adding CELSENTRI to optimised background therapy, compared with 90% in those adding placebo.
Združeni rezulati obeh študij kažejo, da se je pri bolnikih, ki so poleg optimizirane osnovne terapije dodatno jemali zdravilo CELSENTRI, virusno breme po 24 tednih zmanjšalo v povprečju za 99%, v primerjavi z 90% pri bolnikih, ki so dodatno jemali placebo.
The proportion of patients who had undetectable levels of HIV in their blood was about 45% when CELSENTRI was added to optimised background therapy compared with 23% of the patients receiving optimised background therapy only.
Delež bolnikov z nezaznavno koncentracijo HIV v krvi je bil približno 45%, kadar je bilo optimizirani osnovni terapiji dodano zdravilo CELSENTRI, v primerjavi s 23% pri bolnikih, ki so prejemali samo optimizirano osnovno terapijo.
Similar results were also observed when looking at the patients who continued treatment with CELSENTRI 300 mg twice a day for 48 weeks.
Podobni rezultati so bili ugotovljeni tudi pri bolnikih, ki so nadaljevali zdravljenje z zdravilom CELSENTRI 300 mg dvakrat dnevno 48 tednov.
The once- and twice-daily doses of CELSENTRI were of similar effectiveness.
Odmerki zdravila CELSENTRI, dajani enkrat oziroma dvakrat dnevno, so bili podobno učinkoviti.
However, the twice- daily dose was slightly more effective in patients who were at risk of a reduced response to HIV treatment, due to high viral load, low levels of immunity or few available treatment options.
Vendar pa je bil pri bolnikih s tveganjem zmanjšanega odziva na zdravljenje okužbe s HIV zaradi visokega virusnega bremena, nizkih ravni imunosti ali malo razpoložljivih možnosti za zdravljenje odmerek dvakrat dnevno nekoliko učinkovitejši.
What is the risk associated with CELSENTRI?
Kakšna tveganja so povezana z zdravilom CELSENTRI?
The most common side effect with CELSENTRI (seen in more than 1 patient in 10) is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila CELSENTRI (opažen pri več kot 1 izmed 10 bolnikov) je navzeja (občutek slabosti).
For the full list of all side effects reported with CELSENTRI, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila CELSENTRI, glejte Navodilo za uporabo.
CELSENTRI should not be used in patients who may be hypersensitive (allergic) to maraviroc, peanut, soya or any of the other ingredients.
Zdravila CELSENTRI ne smejo uporabljati bolniki, ki utegnejo biti preobčutljivi za (alergični na) maravirok, arašide, sojo ali katero koli drugo sestavino zdravila.
As with other anti-HIV medicines, patients taking CELSENTRI may be at risk of immune reactivation syndrome (symptoms of infection caused by the recovering immune system) or osteonecrosis (death of bone tissue).
Enako kot pri drugih zdravilih proti virusu HIV obstaja pri bolnikih, ki jemljejo zdravilo CELSENTRI, tveganje za sindrom imunske reaktivacije (simptome okužbe, ki jih povzroči imunski sistem, medtem ko se zdravi) ali osteonekrozo (odmiranje kostnega tkiva).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking CELSENTRI.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C), obstaja pri jemanju zdravilo CELSENTRI povečano tveganje za poškodbe jeter.
Why has CELSENTRI been approved?
Zakaj je bilo zdravilo CELSENTRI odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that CELSENTRI’ s benefits are greater than its risks, in combination with other antiretroviral medicinal products, for treatment- experienced adult patients infected with only CCR5-tropic HIV-1 detectable.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila CELSENTRI pri zdravljenju odraslihbolnikov, okuženih samo s CCR5- tropnim HIV- 1, ki so že bili deležni protiretrovirusnega zdravljenja, v kombinaciji z drugimi protiretrovirusnimi zdravili večje od z njim povezanih tveganj.
The Committee recommended that CELSENTRI be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo CELSENTRI odobri dovoljenje za promet.
Other information about CELSENTRI:
Druge informacije o zdravilu CELSENTRI:
The European Commission granted a marketing authorisation valid throughout the European Union for CELSENTRI to Pfizer Limited on 18 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom CELSENTRI, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 18. septembra 2007.
The full EPAR for CELSENTRI can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo CELSENTRI je na voljo tukaj.
EU/ 1/ 07/ 418/ 001 EU/ 1/ 07/ 418/ 002 EU/ 1/ 07/ 418/ 003 EU/ 1/ 07/ 418/ 004 EU/ 1/ 07/ 418/ 005 EU/ 1/ 07/ 418/ 006 EU/ 1/ 07/ 418/ 007 EU/ 1/ 07/ 418/ 008 EU/ 1/ 07/ 418/ 009 EU/ 1/ 07/ 418/ 010
Številka EU EU/ 1/ 07/ 418/ 001 EU/ 1/ 07/ 418/ 002 EU/ 1/ 07/ 418/ 003 EU/ 1/ 07/ 418/ 004 EU/ 1/ 07/ 418/ 005 EU/ 1/ 07/ 418/ 006 EU/ 1/ 07/ 418/ 007 EU/ 1/ 07/ 418/ 008 EU/ 1/ 07/ 418/ 009 EU/ 1/ 07/ 418/ 010
CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI
Izmišljeno ime CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI CELSENTRI
150 mg 150 mg 150 mg 150 mg 150 mg 300 mg 300 mg 300 mg 300 mg 300 mg
Jakost 150 mg 150 mg 150 mg 150 mg 150 mg 300 mg 300 mg 300 mg 300 mg 300 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Farmacevtska oblika Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta Filmsko obložena tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Pot uporabe Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
Bottle (HDPE/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Bottle (HDPE/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu)
Pakiranje Plastenka (HDPE/ alu) Pretisni omot (PVC/ alu) Pretisni omot (PVC/ alu) Pretisni omot (PVC/ alu) Pretisni omot (PVC/ alu) Plastenka (HDPE/ alu) Pretisni omot (PVC/ alu) Pretisni omot (PVC/ alu) Pretisni omot (PVC/ alu) Pretisni omot (PVC/ alu)
180 tablets 30 tablets 60 tablets 90 tablets 180 (2x90) tablets 180 tablets 30 tablets 60 tablets 90 tablets 180 (2x90) tablets
Velikost pakiranja 180 tablet 30 tablet 60 tablet 90 tablet 180 (2x90) tablet 180 tablet 30 tablet 60 tablet 90 tablet 180 (2x90) tablet
Excipients Each 150 mg film-coated tablet contains 0.84 mg of soya lecithin.
Pomožne snovi Ena 150 mg filmsko obložena tableta vsebuje 0, 84 mg sojinega lecitina.
Blue, biconvex, oval film-coated tablets debossed with “ Pfizer” on one side and “ MVC 150” on the other.
Modra, bikonveksna, ovalna filmsko obložena tableta z oznako "Pfizer" na eni strani in "MVC 150" na drugi strani.
CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for treatment- experienced adult patients infected with only CCR5-tropic HIV-1 detectable (see section 4.2).
Zdravilo CELSENTRI je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za uporabo pri odraslih bolnikih, okuženih le z ugotovljivim CCR5- tropnim HIV- 1, ki so že bili zdravljeni (glejte poglavje 4. 2).
This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients (see section 5.1).
Indikacija temelji na podatkih o varnosti in učinkovitosti iz dveh dvojno slepih, s placebom nadzorovanih preskušanj pri bolnikih, ki so že bili zdravljeni (glejte poglavje 5. 1).
CXCR4 or dual/ mixed tropic virus not detected) using an adequately validated and sensitive detection method on a newly drawn blood sample.
Pred uporabo zdravila CELSENTRI je treba potrditi, da je prisoten le CCR5- tropni HIV- 1 (tj. da ni ugotovljen CXCR4 - ali dualno/ mešano- tropni virus); za potrditev je treba uporabiti ustrezno validirano in občutljivo metodo odkrivanja ter svež vzorec krvi.
The Monogram Trofile assay was used in the clinical studies of CELSENTRI (see sections 4.4 and 5.1).
V kliničnih študijah zdravila CELSENTRI so uporabljali Monogramov preskus Trofile (glejte poglavji 4. 4 in 5. 1).
There are currently no data regarding the reuse of CELSENTRI in patients that currently have only CCR5-tropic HIV-1 detectable, but have a history of failure on CELSENTRI (or other CCR5 antagonists) with a CXCR4 or dual/ mixed tropic virus.
Za zdaj ni podatkov o ponovni uporabi zdravila CELSENTRI pri bolnikih, pri katerih je trenutno ugotovljiv samo CCR5- tropni HIV- 1, imajo pa anamnezo o neuspehu zdravljenja z zdravilom CELSENTRI (ali drugimi antagonisti CCR5) s CXCR4 - ali dualno/ mešano- tropnim virusom.
Adults: the recommended dose of CELSENTRI is 150 mg, 300 mg or 600 mg twice daily depending on interactions with co-administered antiretroviral therapy and other medicinal products (see Table 2 in Section 4.5).
Priporočeni odmerek zdravila CELSENTRI je 150 mg, 300 mg ali 600 mg dvakrat na dan, odvisno od interakcij s sočasnim protiretrovirusnim zdravljenjem ali z drugimi zdravili (glejte preglednico 2 v poglavju 4. 5).
Children:
2 Otroci:
CELSENTRI is not recommended for use in children due to lack of data on safety, efficacy and pharmacokinetics (see section 5.2).
Zaradi nezadostnih podatkov o varnosti, učinkovitosti in farmakokinetiki uporaba zdravila CELSENTRI pri otrocih ni priporočljiva (glejte poglavje 5. 2).
2 Elderly: 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.
Renal impairment: dosage adjustment is only recommended in patients with renal impairment who are receiving potent CYP3A4 inhibitors such as: • protease inhibitors (except tipranavir/ ritonavir) • ketoconazole, itraconazole, clarithromycin, telithromycin.
Okvara ledvic: prilagoditev odmerka se pri bolnikih z okvaro ledvic priporoča le, če sočasno jemljejo močne zaviralce CYP3A4, kot so: • zaviralci proteaz (razen tipranivirja/ ritonavirja) • ketokonazol, itrakonazol, klaritromicin, telitromicin
CELSENTRI should be used with caution in patients with renal impairment (CLcr < 80ml/ min) who are taking potent CYP3A4 inhibitors (see sections 4.4 and 5.2).
Pri bolnikih z okvaro ledvic (očistek kreatinina < 80 ml/ min), ki jemljejo močne zaviralce CYP3A4, je treba zdravilo CELSENTRI uporabljati previdno (glejte poglavji 4. 4 in 5. 2).
Table 1 below provides dose interval adjustment guidelines based on simulations of increasing renal impairment in patients being coadministered potent CYP3A4 inhibitors.
Preglednica 1 navaja smernice za prilagajanje odmernega intervala, ki temeljijo na simulaciji stopnjujoče se okvare ledvic pri bolnikih, sočasno zdravljenih z močnimi zaviralci CYP3A4.
Therefore, clinical response to treatment should be closely monitored in these patients.
Varnost in učinkovitost teh prilagoditev odmernega intervala nista klinično ocenjeni, zato je treba pri takšnih bolnikih natančno spremljati klinični odziv.
Dose interval adjustments based on simulations of increasing renal impairment (for dose recommendations, see Section 4.5 Table 2) Recommended CELSENTRI dose interval
Prilagoditve odmernega intervala, ki temeljijo na simulacijah stopnjujoče se okvare ledvic (za priporočila o odmerjanju glejte poglavje 4. 5, preglednico 2) Priporočeni odmerni interval zdravila
Creatinine clearance (CLcr) (ml/ min)
Očistek kreatinina (ml/ min)
50- 80 ml/ min
50– 80 ml/ min
< 30 ml/ min
< 50– 30 ml/ min < 30 ml/ min
Without potent CYP3A4 inhibitors or co- administered with tipranavir/ ritonavir If coadministered with potent CYP3A4
Brez močnih zaviralcev CYP3A4 oz. sočasne uporabe tipranavirja/ ritonavirja Sočasna uporaba z močnimi zaviralci
No dose interval adjustment required
Prilagoditev odmernega intervala ni potrebna
inhibitors, e. g. lopinavir/ ritonavir, darunavir/ ritonavir, atazanavir/ ritonavir, ketoconazole (see also section 4.5)
CYP3A4, npr. z lopinavirjem/ ritonavirjem, darunavirjem/ ritonavirjem, atazanavirjem/ ritonavirjem, ketokonazolom (glejte tudi poglavje 4. 5)
Every 24 hours
Na 24 ur
If coadministered with saquinavir/ ritonavir Every 24 hours
Sočasna uporaba s sakvinavirjem/ ritonavirjem
Every 48 hours
Na 48 ur
Every 72 hours
Na 72 ur
Hepatic impairment: limited data are available in patients with hepatic impairment, therefore CELSENTRI should be used with caution in this population (see sections 4.4 and 5.2).
Podatki pri bolnikih z okvaro jeter so omejeni, zato je treba pri tej populaciji zdravilo CELSENTRI uporabljati previdno (glejte poglavji 4. 4 in 5. 2).
Hypersensitivity to the active substance or to peanut or soya or to any of the excipients.
Preobčutljivost za zdravilno učinkovino, arašide ali sojo ali katerokoli pomožno snov
CELSENTRI should optimally be combined with other antiretrovirals to which the patient's virus is sensitive (see section 5.1).
Zdravilo CELSENTRI je treba uporabljati kot del kombinirane protiretrovirusne sheme.
CELSENTRI should only be used when only CCR5-tropic HIV-1 is detectable (i. e.
Zdravilo CELSENTRI je treba optimalno uporabljati z drugimi protiretrovirusnimi zdravili, na katera je občutljiv bolnikov virus (glejte poglavje 5. 1).
CXCR4 or dual/ mixed tropic virus not detected) as determined by an adequately validated and sensitive detection method (see sections 4.1, 4.2 and 5.1).
Zdravilo CELSENTRI naj bi uporabljali le, če je z ustrezno validirano in občutljivo metodo (glejte poglavja 4. 1, 4. 2 in 5. 1) ugotovljen CCR5- tropni HIV- 1 (tj. ni odkrit CXCR4 - ali dualno/ mešano - tropni virus).
The Monogram Trofile assay was used in the clinical studies of CELSENTRI.
V kliničnih študijah zdravila CELSENTRI so uporabljali Monogramov preskus Trofile.
Changes in viral tropism occur over time in HIV-1 infected patients.
Pri bolnikih z okužbo s HIV- 1 sčasoma pride do sprememb v tropizmu virusa.
Therefore there is a need to start therapy shortly after a tropism test.
Zdravljenje je torej treba začetki v kratkem času po testu tropizma.
Background resistance to other classes of antiretrovirals have been shown to be similar in previously undetected CXCR4-tropic virus of the minor viral population, as that found in CCR5-tropic virus.
3 Ugotovljeno je, da je odpornost predhodno neodkritih CXCR4- tropnih virusov iz manjšinske virusne populacije proti drugim skupinam protiretrovirusnih zdravil podobna kot odpornost CCR5- tropnih virusov.
Dose adjustment: physicians should ensure that appropriate dose adjustment of CELSENTRI is made when CELSENTRI is co-administered with CYP3A4 inhibitors and/ or inducers since maraviroc concentrations and its therapeutic effects may be affected (see sections 4.2 and 4.5).
Zdravnik mora poskrbeti za ustrezno prilagoditev odmerka zdravila CELSENTRI, kadar je le- ta uporabljen sočasno z zaviralci in/ ali induktorji CYP3A4; takšna sočasna uporaba namreč lahko vpliva na koncentracijo maraviroka in njegove terapevtske učinke (glejte poglavji 4. 2 in 4. 5).
3 Information for patients: patients should be advised that antiretroviral therapies including CELSENTRI have not been shown to prevent the risk of transmission of HIV to others through sexual contact or contamination with blood.
Bolnikom morate povedati, da za protiretrovirusna zdravila, vključno z zdravilom CELSENTRI, ni dokazano, da bi preprečevala tveganje prenosa virusa HIV na druge osebe s spolnim stikom ali kontaminacijo s krvjo.
They should continue to use appropriate precautions.
Zato morajo bolniki nadaljevati z ustreznimi previdnostnimi ukrepi.
Patients should also be informed that CELSENTRI is not a cure for HIV-1 infection.
Prav tako morate bolnikom povedati, da zdravilo CELSENTRI ne ozdravi okužbe s HIV.
Postural hypotension: when CELSENTRI 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 zdravilo CELSENTRI uporabili v študijah pri zdravih prostovoljcih v odmerkih, večjih od priporočenih, so zabeležili primere simptomatske posturalne hipotenzije pogosteje kot pri placebu.
However, when CELSENTRI was given at the recommended dose in HIV infected patients in Phase 3 studies, postural hypotension was seen at a similar rate compared to placebo (approximately 0.5%).
Toda ko so zdravilo CELSENTRI v študijah 3. faze pri bolnikih, okuženih s HIV, uporabljali v priporočenem odmerku, je bila pogostnost posturalne hipotenzije podobna kot pri placebu (približno 0, 5%).
Caution should be used when administering CELSENTRI in patients with a history of postural hypotension or on concomitant medicinal products known to lower blood pressure.
Previdnost je potrebna, če zdravilo CELSENTRI uporabljamo pri bolnikih z anamnezo posturalne hipotenzije ali pri bolnikih, ki sočasno jemljejo zdravila, za katera je znano, da znižujejo krvni tlak.
Potential effect on immunity:
Potencialni vpliv na imunost:
The incidence of AIDS-defining infections was similar between CELSENTRI and placebo arms in the pivotal studies.
V ključnih študijah je bila incidenca okužb, značilnih za aids, podobna med kraki z zdravilom CELSENTRI ter s placebom.
Cardiovascular safety: limited data exist with the use of CELSENTRI in patients with severe cardiovascular disease, therefore special caution should be exercised when treating these patients with CELSENTRI.
O uporabi zdravila CELSENTRI pri bolnikih s hudimi srčnožilnimi boleznimi so na voljo le omejeni podatki, zato je pri zdravljenju teh bolnikov z zdravilom CELSENTRI potrebna posebna previdnost.
Immune reconstitution syndrome: in HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Pri bolnikih, okuženih s HIV, ki imajo v času uvedbe kombinirane protiretrovirusne terapije (KPRT) hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične patogene ter povzroči resna klinična stanja ali poslabšanje simptomov.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and pneumonia caused by Pneumocystis jiroveci (formerly known as Pneumocystis carinii).
Pomembni primeri so citomegalovirusni retinitis, generalizirane in/ ali fokalne okužbe z mikobakterijami in pljučnica s Pneumocystis jiroveci (včasih imenovana Pneumocystis carinii).
Osteonecrosis: although the etiology 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, 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).
Hepatic safety: the safety and efficacy of CELSENTRI have not been specifically studied in patients with significant underlying liver disorders.
Varnost in učinkovitost zdravila CELSENTRI nista specifično raziskani pri bolnikih s pomembno osnovno boleznijo jeter.
A case of possible CELSENTRI-induced hepatotoxicity with allergic features has been reported in a study in healthy volunteers.
V študiji zdravih prostovoljcev je bil opisan en primer hepatotoksičnosti z alergijskimi značilnostmi, ki bi jo lahko povzročilo zdravilo CELSENTRI.