natgillin/translations-raw huggingface dataset:
Inflammation of the liver, sometimes with jaundice (yellowing of the skin and eyes), swelling of the belly.
Redki (pri več kot enem od deset- tisočih, a manj kot pri enem od tisočih bolnikov): vnetje jeter, včasih z zlatenico (porumenelost kože in oči), zatečenost trebuha.
New onset diabetes mellitus, high blood sugar or an increase in severity of existing diabetes mellitus has been rarely reported in patients receiving protease inhibitors.
Pri bolnikih, ki so prejemali proteazne zaviralce, so se redko pojavili sladkorna bolezen, visok sladkor v krvi ali poslabšanje obstoječe sladkorne bolezni.
In some of these the high blood sugar was severe and in some cases also associated with ketoacidosis (change in metabolite levels in the blood).
Pri nekaterih je bil sladkor v krvi zelo povišan in v posameznih primerih celo povezan s ketoacidozo (spremembe koncentracij presnovkov v krvi).
Many of these patients had additional medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or high blood sugar.
Mnogi od teh bolnikov so imeli dodatna bolezenska stanja, nekatera od njih so zahtevala zdravljenje z učinkovinami, ki so bile povezane z razvojem sladkorne bolezni ali pojavom visokega sladkorja v krvi.
In patients with haemophilia type A and B (patients who have blood clotting problems), there have been rare reports of increased bleeding while taking this treatment or another protease inhibitor.
Pri bolnikih s hemofilijo tipa A in B (bolniki z motnjami v strjevanju krvi) so redko poročali o povečani krvavitvi med zdravljenjem s tem zdravilom ali drugim proteaznim zaviralcem.
Should this happen to you, seek immediate advice from your doctor.
Če bi se pojavila pri vas, takoj poiščite nasvet svojega zdravnika.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Kombinirano protiretrovirusno zdravljenje lahko povzroči spremembe oblike telesa zaradi prerazporeditve maščevja.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (’buffalo hump’).
Spremembe lahko zajemajo izgubo maščevja na nogah, rokah in obrazu, povečanje maščevja v abdomnu (trebuhu) in drugih notranjih organih, povečanje prsi in maščobne kepe na zadnjem delu vratu (bivolja grba).
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Kombinirano protiretrovirusno zdravljenje lahko povzroči tudi zvišane koncentracije mlečne kisline in sladkorja v krvi, hiperlipidemijo (povečanje maščob v krvi) in odpornost na inzulin.
There have been rare reports of muscle pain, tenderness or weakness, particularly with combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Pojavili so se tudi redki primeri bolečin v mišicah, občutljivosti ali oslabelosti, posebno ob jemanju kombiniranega protiretrovirusnega zdravljenja, vključno s proteaznimi zaviralci in nukleozidnimi analogi.
About 400 children and neonates (aged from 0 to 13 years) received VIRACEPT in clinical trials.
V kliničnih preskušanjih je zdravilo VIRACEPT prejelo okrog 400 otrok in novorojenčkov (starih od 0 do 13 let).
The side effects seen in children and neonates are similar to those seen in adults.
Neželeni učinki, ki so jih opazili pri otrocih in novorojenčkih, so podobni tistim, ki so jih opazili pri odraslih.
The side effects only rarely resulted into having to stop taking VIRACEPT.
Zaradi neželenih učinkov je bilo redko treba prenehati z jemanjem zdravila VIRACEPT.
Do not use after the expiry date stated on the label and carton.
Shranjujte pri temperaturi do 30 °C.
What VIRACEPT contains Each gram of oral powder contains nelfinavir mesilate corresponding to 50 mg of nelfinavir.
Kaj vsebuje zdravilo VIRACEPT Vsak gram peroralnega praška vsebuje 50 mg nelfinavirja v obliki nelfinavirjevega mesilata.
Important information about some of the ingredients:
Pomembne informacije o nekaterih sestavinah:
May be harmful for people with phenylketonuria.
Lahko škoduje ljudem z fenilketonurijo.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium- free’.
To zdravilo vsebuje manj kot 1 mmol (39 mg) kalija na odmerek, kar v bistvu pomeni brez kalija.
This is to be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet
To morajo upoštevati bolniki, ki imajo zmanjšano funkcijo ledvic ali bolniki, ki so na dieti z nadzorovanim vnosom kalija.
VIRACEPT 50 mg/g oral powder is provided in HDPE plastic bottles fitted with polypropylene child resistant closures with a polyethylene liner.
Izgled zdravila VIRACEPT in vsebina pakiranja Peroralni prašek VIRACEPT 50 mg/ g je na voljo v HDPE plastičnih stekleničkah s polipropilensko za otroke varno zaporko in polietilenskim vložkom.
Each bottle contains 144 grams of oral powder and is supplied with a 1 gram (white) and a 5 gram (blue) polypropylene scoop.
Vsaka steklenica vsebuje 144 gramov peroralnega praška, v njej pa sta priloženi bela polipropilenska merica po 1 gram in modra polipropilenska merica po 5 gramov.
52 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
55 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
VIRACEPT 250 mg film-coated tablets Nelfinavir
VIRACEPT 250 mg filmsko obložene tablete nelfinavir
You should, therefore, remain under the care of your doctor while taking VIRACEPT.
Bodite posebno pozorni pri jemanju zdravila VIRACEPT Zavedati se morate, da zdravilo VIRACEPT ne ozdravi okužbe z virusom HIV, in da se lahko razvoj okužb in ostalih bolezni, povezanih z virusom HIV, nadaljuje, zato morate med jemanjem zdravila VIRACEPT ostati pod nadzorom svojega zdravnika.
54 Treatment with VIRACEPT has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
Zdravljenje z zdravilom VIRACEPT ne zmanjša tveganja prenosa virusa HIV na druge osebe s spolnim stikom ali z okuženo krvjo.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
57 Pri bolnikih, ki prejemajo kombinirano protiretrovirusno zdravljenje, se lahko pojavi prerazporeditev, kopičenje ali izguba telesne maščobe.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
In other cases increased monitoring and/or a change in the dose of these medicines or of VIRACEPT may be needed: ritonavir, indinavir, saquinavir and delavirdine (used in the treatment of HIV infection),
V drugih primerih pa bo morda potreben dodaten nadzor in/ ali sprememba odmerka teh zdravil ali odmerka zdravila VIRACEPT:
55 rifabutin (used for treating bacterial infections), birth control pills (may not prevent pregnancy when given with VIRACEPT so other birth control methods should be used), calcium channel blockers including bepridil (for the treatment of heart conditions), immunosuppressants including tacrolimus and ciclosporin, sildenafil (for male impotence), statins (used to lower lipid levels in the blood), phenobarbital, phenytoin or carbamazepine (used in the treatment of epilepsy), methadone (used in the treatment of opiate dependence), lansoprazole and other medicines which reduce stomach acid, sedative agents (i.e. midazolam administered by injection).
58 ritonavir, indinavir, sakvinavir in delavirdin (za zdravljenje okužb z virusom HIV), rifabutin (za zdravljenje bakterijskih okužb), kontracepcijske tablete (morda ne bodo preprečile nosečnosti, če jih jemljete skupaj z zdravilom VIRACEPT, zato je priporočljiva uporaba drugih metod kontracepcije), blokatorji kalcijevih kanalčkov, vključno z bepridilom (za zdravljenje bolezni srca), zaviralci imunske odzivnosti vključno s takrolimusom in ciklosporinom, sildenafil (za zdravljenje moške impotence), statini (za zmanjšanje koncentracij lipidov v krvi), fenobarbital, fenitoin ali karbamazepin (za zdravljenje epilepsije), metadon (za zdravljenje zasvojenosti z opiati), lansoprazol in druga zdravila, ki zavirajo izločanje želodčne kisline, pomirjevala (t. j. midazolam dan z injekcijo).
Severe interactions with other medicines would not be expected with the following medicines but the possibility cannot be excluded: amprenavir, efavirenz and nevirapine (used in the treatment of HIV infection); ketoconazole, itraconazole and fluconazole (used for treating fungal infections); erythromycin and clarithromycin (used for treating bacterial infections); fluoxetine, paroxetine, imipramine and amitriptyline (used in the treatment of depression), diazepam (used to relieve anxiety and/or trouble with sleeping).
Klinično pomembnih medsebojnih delovanj ni pričakovati z naslednjimi zdravili, vendar pa možnosti ne moremo izključiti: amprenavir, efavirenz in nevirapin (za zdravljenje okužb z virusom HIV); ketokonazol, itrakonazol in flukonazol (za zdravljenje glivičnih okužb), eritromicin in klaritromicin (za zdravljenje bakterijskih okužb); fluoksetin, paroksetin, imipramin in amitriptilin (za zdravljenje depresije); diazepam (za zdravljenje tesnobe in/ ali težav z nespečnostjo).
To obtain the full benefit of VIRACEPT, the tablets should be taken with a meal.
Jemanje zdravila VIRACEPT skupaj s hrano in pijačo Da vam bo zdravilo VIRACEPT najbolje koristilo, morate zdravilo VIRACEPT zaužiti z obrokom.
Ask your doctor or pharmacist for advice before taking any medicine.
Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
This medicine should be taken during pregnancy only after consultation with your doctor.
Če ste noseči, lahko jemljete zdravilo VIRACEPT le na podlagi odločitve vašega zdravnika.
The tablet form of VIRACEPT must be taken by mouth.
Zdravilo VIRACEPT v obliki tablet je treba jemati peroralno.
VIRACEPT film-coated tablets should be swallowed whole and should be taken with a meal.
Filmsko obložene tablete VIRACEPT je treba pogoltniti cele in skupaj z obrokom.
For adults and children older than 13 years, the recommended dose of VIRACEPT 250 mg film-coated tablets is 1250 mg given as five 250 mg tablets twice daily (BID) or 750 mg given as three 250 mg tablets three times daily (TID).
Za odrasle in otroke, starejše od 13 let, je priporočeni odmerek filmsko obloženih tablet VIRACEPT 250 mg 1. 250 mg, ki se ga da kot pet tablet po 250 mg dvakrat na dan ali 750 mg, ki se ga da kot tri tablete po 250 mg trikrat na dan.
For children, aged 3 to 13 years, the recommended dose is either 50-55 mg/kg body weight if VIRACEPT is taken twice daily (BID) or 25-30 mg per kg of body weight if VIRACEPT is taken three times daily (TID) as follows:
Za otroke, stare 3 do 13 let, je priporočeni odmerek filmsko obloženih tablet VIRACEPT 250 mg 50 do 55 mg zdravila na kg telesne mase dvakrat na dan ali 25 do 30 mg zdravila na kg telesne mase trikrat na dan.
If you are receiving VIRACEPT film-coated tablets twice a day
Jemanje filmsko obloženih tablet VIRACEPT dvakrat na dan
18 to < 22 ≥ 22
Telesna masa (kg) 18 do < 22 ≥ 22
4 5
dvakrat na dan * 4 5
56 If you are receiving VIRACEPT film-coated tablets three times a day
59 Jemanje filmsko obloženih tablet VIRACEPT trikrat na dan
18 to < 23 ≥ 23
Telesna masa (kg) 18 do < 23 ≥ 23
2 3
trikrat na dan * 2 3
*see Package Leaflet for VIRACEPT oral powder for patients less than 18 kg body weight.
* Glejte navodilo za uporabo peroralnega praška VIRACEPT za bolnike, ki imajo telesno maso pod 18 kg.
For adults or children unable to take tablets, VIRACEPT 50 mg/g oral powder may be administered (see Package Leaflet for VIRACEPT 50 mg/g oral powder).
Odrasli ali otroci, ki ne morejo jemati tablet, lahko jemljejo peroralni prašek VIRACEPT 50 mg/ g (glejte navodilo za uporabo peroralnega praška VIRACEPT 50 mg/ g).
If you realise you have taken more VIRACEPT than you should have, contact your doctor right away.
Če ste vzeli večji odmerek zdravila VIRACEPT, kot bi smeli Če ugotovite, da ste vzeli večji odmerek zdravila VIRACEPT, kot bi smeli, se takoj posvetujte s svojim zdravnikom.
If you cannot reach your doctor, go to the nearest emergency room and take your VIRACEPT tablets with you.
Če vaš zdravnik ni dosegljiv, poiščite najbližji intenzivni oddelek in vzemite tablete VIRACEPT s sabo.
Take the next dose as soon as you remember and then carry on as before.
Če ste pozabili vzeti zdravilo VIRACEPT Vzemite naslednji odmerek takoj, ko se spomnite in nadaljujte kot običajno.
If you stop taking VIRACEPT Continue to take this medicine until your doctor tells you otherwise.
Če ste prenehali jemati zdravilo VIRACEPT Nadaljujte z jemanjem tega zdravila, dokler vam zdravnik ne naroči drugače.
57 New onset diabetes mellitus, high blood sugar or an increase in severity of existing diabetes mellitus has been rarely reported in patients receiving protease inhibitors.
60 Pri bolnikih, ki so prejemali proteazne zaviralce, so se redko pojavili sladkorna bolezen, visok sladkor v krvi ali poslabšanje obstoječe sladkorne bolezni.
Many of these patients had additional medical conditions, some of which required therapy with agents that have been associated with the development of diabetes or high blood sugar.
Mnogi od teh bolnikov so imeli dodatna bolezenska stanja, nekatera od njih so zahtevala zdravljenje z učinkovinami, ki so povezane z razvojem sladkorne bolezni ali pojavom visokega sladkorja v krvi.
The active substance is nelfinavir.
Kaj vsebuje zdravilo VIRACEPT Zdravilna učinkovina je nelfinavir.
VIRACEPT 250 mg film-coated tablets contain 292.25 mg of nelfinavir mesilate corresponding to 250 mg of nelfinavir.
VIRACEPT 250 mg filmsko obložene tablete vsebujejo 292, 25 mg nelfinavirjevega mesilata, kar ustreza 250 mg nelfinavirja.
VIRACEPT film-coated tablets are provided in HDPE plastic bottles containing either 270 or 300 tablets, fitted with HDPE child resistant closures with polyethylene liners.
Izgled zdravila VIRACPET in vsebina pakiranja VIRACEPT filmsko obložene tablete so na voljo v HDPE plastičnih stekleničkah, ki vsebujejo 270 ali 300 tablet, s HDPE za otroke varno zaporko in polietilenskim vložkom.
58 Marketing Authorisation Holder and Manufacturer
61 Imetnik dovoljenja za promet z zdravilom in izdelovalec
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Izdelovalec Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach/ Wyhlen Nemčija
d se EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
VIRAFERON
t me VIRAFERON
ori EPAR summary for the public
Povzetek EPAR za javnost
uth This document is a summary of the European Public Assessment Report (EPAR).
p ro Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene študije, na podlagi
ra If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
ge of the EPAR).
nja prav tako del EPAR).
What is Viraferon? lon Viraferon is a medicine containing the active substance interferon alfa-2b.
Viraferon je zdravilo, ki vsebuje zdravilno učinkovino interferon alfa- 2b.
It is available as a powder and solvent to be made up into a solution for injection or infusion, as a ready-to-use solution for injection and as a multidose pen for injection.
Na voljo je kot prašek in vehikel za pripravo raztopine za injiciranje ali infundiranje, kot predhodno pripravljena raztopina za vo injiciranje ter kot večodmerni peresnik za injiciranje.
These contain from 1 to 50 million IU (international units) per millilitre. no
Te oblike vsebujejo od 1 do 50 milijonov mednarodnih enot na mililiter. do
Viraferon is used for the treatment of: • chronic (long-term) hepatitis B (a disease of the liver due to an infection by the hepatitis B virus) t
Zdravilo Viraferon se uporablja za zdravljenje: • kroničnega (dolgotrajnega) hepatitisa B (bolezni jeter, ki je posledica okužbe z virusom hepatitisa eā
• chronic hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
B) pri odraslih; • kroničnega hepatitisa C (bolezni jeter, ki je posledica okužbe z virusom hepatitisa C).
In adults Viraferon can be used on its own but is best used in combination with ribavirin (an antiviral medicine).
kombinaciji z ribavirinom (protivirusnim zdravilom).
In children it is used with ribavirin. rod
Pri otrocih se uporablja v kombinaciji z ribavirinom.
The medicine can only be obtained with a prescription.
Zdravilo se dobi samo na recept. nim
Treatment with Viraferon should be initiated by a doctor who has experience in the management of lp
Zdravljenje z zdravilom Viraferon mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katero se uporablja.
For more information, see the Package Leaflet. ina
Odmerek in trajanje zdravljenja sta odvisna od zdravljene bolezni in odziva bolnika, pri čemer se odmerki gibljejo v razponu od 3 do 10 milijonov mednarodnih enot na kvadratni meter ilo
Viraferon has to be stored in a refrigerator (2°C-8°C).
Zdravilo Viraferon je treba hraniti v hladilniku (2 °C– 8 ºC). rav
Interferons dic
Zdravilna učinkovina zdravila Viraferon, interferon alfa- 2b, spada v skupino interferonov.
The exact way alpha interferons work in viral diseases is not fully understood, but it is thought that they act as immunomodulators (substances that modify how the immune system, the Me
Zd
Alpha interferons may also block the multiplication of viruses.
Natančen način delovanja interferonov alfa pri virusnih boleznih ni v celoti znan, vendar se domneva, da delujejo kot imunomodulatorji (snovi, ki spreminjajo način delovanja imunskega sistema, obrambnega sistema telesa).
The interferon alfa-2b in Viraferon is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which
Interferoni alfa utegnejo tudi blokirati razmnoževanje virusov.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Interferon alfa- 2b, ki ga vsebuje zdravilo Viraferon, se proizvaja po metodi, imenovani „ rekombinantna DNA tehnologija “: proizvaja ga bakterija, ki je prejela gen (DNA), kar ji omogoča 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. makes it able to produce it.
Reproduction is authorised provided the source is acknowledged. njegovo tvorjenje.
d Because interferon alfa-2b has been used to treat a number of diseases in the European Union (EU) before, the company that makes Viraferon supplied data from the scientific literature and from studies
t zdravila Viraferon, uporabljenega samostojno ali v kombinaciji z ribavirinom pri zdravljenju
se of its use in children with chronic hepatitis B.
me kroničnega hepatitisa C.
The company also supplied information from a number of studies of Viraferon used alone or with ribavirin for the treatment of chronic hepatitis C.
V teh študijah je sodelovalo skupno 2552 predhodno nezdravljenih bolnikov (ki dotlej še niso prejemali zdravil) in skupno 345 bolnikov, pri katerih se je bolezen ponovila po predhodnem zdravljenju z interferonom.
These included a total of 2,552 treatment-naïve patients (who had not been treated before) and a total of 345
Uporabo zdravila Viraferon v kombinaciji z ribavirinom so
The use of Viraferon in combination with ribavirin has also been studied in 118 hepatitis C treatment-naïve children aged between three and 16 years.
p ro preučevali tudi pri 118 predhodno nezdravljenih otrocih s hepatitisom C, starimi med tri in 16 let.
uth What benefit has Viraferon shown during the studies?
Kakšne koristi je zdravilo Viraferon izkazalo med raziskavami?
The studies showed that Viraferon is effective in the diseases for which it can be used.
Študije so pokazale, da je zdravilo Viraferon učinkovito pri zdravljenju bolezni, za katere je
Viraferon was also shown to have a benefit in children with chronic hepatitis B.
Zdravilo Viraferon je izkazalo koristi tudi pri otrocih s kroničnim hepatitisom B.
Viraferon, with or without ribavirin,
V kombinaciji z ribavirinom je
It was also effective in children when used with ribavirin, with 46% of the children having responded to treatment at the six-month follow up visit following a year’ s treatment.
nja bilo učinkovito tudi pri otrocih, saj je bilo ob pregledu po šestmesečnem obdobju spremljanja, ki je sledilo enoletnemu zdravljenju, ugotovljeno, da se je na zdravljenje odzvalo 46% otrok.
ge What is the risk associated with Viraferon?
Kakšna tveganja so povezana z zdravilom Viraferon?
The most common side effects with Viraferon in adults (seen in more than 1 patient in 10) are leucopenia (low white blood cell counts), anorexia (loss of appetite), depression, insomnia (difficulty lon sleeping), anxiety, agitation, nervousness, dizziness, headache, impaired concentration, dry mouth, blurred vision, nausea (feeling sick) or vomiting, abdominal (tummy) pain, diarrhoea, stomatitis (inflammation of the lining of the mouth), dyspepsia (indigestion), alopecia (hair loss), increased sweating, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the site of the injection, fatigue (tiredness), rigors (shaking chills), fever, flu- no
Najpogostejši neželeni učinki zdravila Viraferon pri odraslih (opaženi pri več kot 1 bolniku od 10) so levkopenija (majhno število belih krvnih celic), anoreksija (izguba teka), depresija, nespečnost vo (težave s spanjem), anksioznost, vznemirjenost, živčnost, omotica, glavobol, motnje koncentracije, suha usta, zamegljen vid, navzeja (občutek slabosti) ali bruhanje, bolečine v trebuhu, driska, stomatitis (vnetje ustne sluznice), dispepsija (slaba prebava), alopecija (izpadanje las), prekomerno do
like symptoms, asthenia (weakness), irritability, chest pain, malaise (feeling unwell) and weight loss.
Podobni neželeni učinki so bili opaženi pri otrocih, eā
Similar side effects have been seen in children receiving Viraferon, as well as inhibition of growth.
ki so prejemali zdravilo Viraferon, kakor tudi zavirana rast.
Viraferon should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or t
Zdravilo Viraferon se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) av
Viraferon should not be used in: uc
interferon alfa- 2b ali katero koli drugo sestavino.
• patients with a history of severe heart disease, • patients with severe kidney or liver disease including that caused by cancer, • patients with epilepsy or other central nervous system problems, rod
Zdravila Viraferon se ne sme uporabljati pri: • bolnikih z anamnezo hudega obolenja srca, • bolnikih s hudo boleznijo ledvic ali jeter, vključno s takšno, ki jo povzroča rak, nim
• patients with thyroid disease unless it is controlled, • hepatitis patients who have liver cirrhosis (scarring) that is causing symptoms or who have recently received medicines that affect the immune system, • patients with a history of certain disorders of the immune system, or who have had an organ lp
• bolnikih z epilepsijo ali drugimi motnjami delovanja centralnega živčnega sistema, • bolnikih z boleznijo ščitnice, razen če je obvladana, • bolnikih s hepatitisom, ki imajo cirozo jeter, ki povzroča simptome, ali ki so nedavno prejemali zdravila, ki vplivajo na imunski sistem, • bolnikih, ki imajo določene motnje imunskega sistema v anamnezi ali so imeli presaditev organa ilo