natgillin/translations-raw huggingface dataset:
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needlesPack of 1, 10, 20 
M-M-RVAXPRO - prašek v viali in vehikel v napolnjeni injekcijski brizgi z dvema nepritrjenima iglama - pakiranje po 1, 10, 20
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live) 
M-M-RVAXPRO prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti ošpicam, mumpsu in rdečkam (živo)
In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously. 
V kliničnem preskušanju je bilo s cepivom M-M-RVAXPRO intramuskularno (i.m.)
M-M-RVAXPRO is given as follows: 
Pri uporabi cepiva M-M-RVAXPRO so poročali o naslednjih neželenih učinkih:
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in pack size 1, 10, and 20. 
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma), brez igle, v pakiranju po 1, 10 in 20.
However, foetal damage has not been documented when measles or mumps vaccines have been given to pregnant women. 
Pri nosečnicah, ki so jih cepili s cepivi proti ošpicam ali mumpsu, niso zabeležili okvare ploda.
Measles virus 
Virus ošpic
Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator 
Po pripravi uporabite takoj ali v 8 urah, če ste shranjevali v hladilniku.
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needlePack of 1, 10, 20 
M-M-RVAXPRO - prašek v viali in vehikel v napolnjeni injekcijski brizgi z eno nepritrjeno iglo - pakiranje po 1, 10, 20
How to use M-M-RVAXPRO 4. 
Kako uporabljati cepivo M-M-RVAXPRO.
EU/1/06/337/008 - pack of 1 EU/1/06/337/009 - pack of 10 EU/1/06/337/010 - pack of 20 
EU/1/06/337/008 - pakiranje po 1 EU/1/06/337/009 - pakiranje po 10 EU/1/06/337/010 - pakiranje po 20
EU/1/06/337/005 - pack of 1 EU/1/06/337/006 - pack of 10 EU/1/06/337/007 - pack of 20 
EU/1/06/337/005 - pakiranje po 1 EU/1/06/337/006 - pakiranje po 10 EU/1/06/337/007 - pakiranje po 20
Tel: 8007 4433 (+356 99917558) malta_info@merck.com 
Merck Sharp & Dohme Cyprus Limited., Tel: 8007 4433 (+356 99917558) malta_info@merck.com
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a vial (glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10. 
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v viali (steklo) z zamaškom (klorobutilna guma) v pakiranju po 1 in 10.
• Injection-site bruising. 
• izpuščaj na mestu injiciranja
Injection site pain, and Injection site swelling Injection site bruising 
• rdečina na mestu injiciranja, bolečina na mestu injiciranja, oteklina na mestu injiciranja
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10. 
Prašek v viali (steklo) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in z iglo z zaščito (iz naravne gume) v pakiranju po 1 in 10.
What M-M-RVAXPRO contains 
Kaj vsebuje cepivo M-M-RVAXPRO
EU/1/06/337/003 - pack of 1 EU/1/06/337/004 - pack of 10 
EU/1/06/337/003 - pakiranje po 1 EU/1/06/337/004 - pakiranje po 10
Powder and solvent for suspension for injection 1 single dose vial (powder) + 1 vial (solvent). 
prašek in vehikel za suspenzijo za injiciranje 1 enoodmerna viala (prašek) + 1 viala (vehikel) 10 enoodmernih vial (prašek) + 10 vial (vehikel)
3 CCID50* Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) not less than 12,5 x10 
1, sev Jeryl Lynn™ (nivo B) (živ, oslabljen) ...............najmanj 12,5 x 10
1 Enders' Edmonston strain (live, attenuated) …………...….not less than 1x10 3 CCID50* 
1, sev Enders' Edmonston (živ, oslabljen) .........................najmanj 1 x 10
Nausea 
• jok
EU/1/06/337/001 - pack of 1 EU/1/06/337/002 - pack of 10 
EU/1/06/337/001 - pakiranje po 1 EU/1/06/337/002 - pakiranje po 10
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe without needle - Pack of 1, 10, 
M-M-RVAXPRO - prašek v viali in vehikel v napolnjeni injekcijski brizgi brez igle - pakiranje po 1, 10, 20
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 2 needles. 
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 enoodmerna viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) + 2 igli 10 enoodmernih vial (prašek) + 10 napolnjenih injekcijskih brizg (vehikel) + 20 igel 20 enoodmernih vial (prašek) + 20 napolnjenih injekcijskih brizg (vehikel) + 40 igel
1 Enders' Edmonston strain (live, attenuated) ………...…….not less than 1x10 3 CCID50* 
1, sev Enders' Edmonston (živ, oslabljen)...................najmanj 1 x 10
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) with needle. 
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 enoodmerna viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) z iglo 10 enoodmernih vial (prašek) +10 napolnjenih injekcijskih brizg (vehikel) z iglami
• Deafness. 
• gluhost
Potassium phosphate 
• otekle bezgavke
Burning and/or Stinging of short duration at the injection site, Malaise, Papillitis, Peripheral oedema, Swelling, Tenderness, Vesicles at the injection site, Wheal and Flare at the injection site 
Splošne težave in spremembe na mestu aplikacije zvišana telesna temperatura (38,5 °C ali več), eritem na mestu injiciranja, bolečina na mestu injiciranja in oteklina na mestu injiciranja zelo pogosti modrica na mestu injiciranja pogosti izpuščaj na mestu injiciranja občasni kratkotrajen pekoč občutek in/ali zbadanje na mestu injiciranja, slabo počutje, papilitis, periferni edem, otekanje, občutljivost, mehurčki na mestu injiciranja, mehurčki in rdečina na mestu injiciranja - kot pri kožnih testih neznana pogostnost
M-M-RVAXPRO should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm. Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site. 
Ponavadi je predel stegna najprimernejše mesto za injiciranje pri mlajših otrocih, pri starejših posameznikih pa nadlaket.
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) without needle. 
prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 enoodmerna viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) brez igle 10 enoodmernih vial (prašek) + 10 napolnjenih injekcijskih brizg (vehikel) brez igel 20 enoodmernih vial (prašek) + 20 napolnjenih injekcijskih brizg (vehikel) brez igel
It is not known whether measles or mumps vaccine virus is secreted in human milk; therefore, caution should be exercised when M-M-RVAXPRO is administered to a breast-feeding woman. 
Ni znano, ali se cepilni virus ošpic ali mumpsa izloča v materino mleko.
Ear and labyrinth disorders Nerve deafness 
Ušesne bolezni, vključno z motnjami labirinta nevralna gluhost neznana pogostnost
2 Wistar RA 27/3 strain (live, attenuated) ………………..….not less than 1x10 3 CCID50* 
Virus rdečk 2, sev Wistar RA 27/3 (živ, oslabljen) ..............................najmanj 1 x 10
Withdraw the entire volume of solvent into a syringe. 
V brizgo potegnite celoten volumen vehikla.
Medium 199 with Hanks' salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin 
Prašek sorbitol natrijev fosfat kalijev fosfat saharoza hidrolizirana želatina medij 199 s Hanksovimi solmi minimalni esencialni medij, Eagle (MEM) natrijev L-glutamat neomicin fenol rdeče natrijev hidrogenkarbonat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
Medicinal product subject to medical prescription. 
Predpisovanje in izdaja cepiva je le na recept.
This is expected and may last for a few months. 
To se pričakuje in lahko traja nekaj mesecev.
Time (months) 
Čas (meseci)
This generally does not mean that your blood cancer is getting worse. 
Vendar pa to navadno ne pomeni, da se stanje vašega krvnega raka slabša.
Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019 
Datum prve odobritve: 18. september 2014 Datum zadnjega podaljšanja: 30. apríl 2019
This list is not exhaustive and is intended to serve as guidance only. 
Seznam ni izčrpen in velja samo kot smernica.
Then take your next dose as usual. 
Naslednji odmerek vzemite kot običajno.
This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect. 
To je izredno pomembno, saj lahko uporaba več kot enega zdravila hkrati okrepi ali oslabi učinek teh zdravil.
N at risk (Events) 
N s tveganjem (dogodki)
The median duration of response (DOR) has not been reached. 
Mediana trajanja odziva (DORduration of response) ni bila dosežena.
Progression free survival (%) 
Preživetje brez napredovanja (%)
Your doctor will monitor you for evidence of infection. 
Vaš zdravnik vas bo spremljal za znake okužbe.
Talk to your doctor about what your test results mean. 
Pogovorite se s svojim zdravnikom, kaj vaši rezultati preiskav pomenijo.
Do not give this medicine to children and adolescents under 18 years of age because it has not been studied in this age group. 
Tega zdravila ne dajajte otrokom in mladostnikom, starim manj kot 18 let, saj zdravila v tej starostni skupini niso preučili.
Effects of food 
Učinek hrane
Infections (see section 4.4) 
Okužbe (glejte poglavje 4.4)
The median number of prior therapies was 3.0. 
Mediano število predhodnih zdravljenj je bilo 3,0.
The median time since diagnosis was 7.7 years. 
Mediani čas od diagnoze je bil 7,7 let.
It is very important that you read the package leaflets that are provided with these medicines too. 
Zelo pomembno je, da preberete tudi navodila za uporabo, priložena tem zdravilom.
Tell your doctor: 
Zdravniku povejte:
The analysis of PFS was based on evaluation by an IRC. 
Analiza PFS temelji na oceni IRC.
→ Talk to your doctor if this applies to you. 
→ Posvetujte se z zdravnikom, če to velja za vas.
There is no information about the safety of this medicine in pregnant women. 
O varnosti tega zdravila pri nosečnicah ni podatkov.
STOP taking Zydelig and seek medical help immediately if you experience any of the following: 
PRENEHAJTE jemati zdravilo Zydelig in takoj poiščite zdravniško pomoč, če se pojavi kar koli od naslednjega:
Age ≥ 65 years 
Starost ≥ 65 let
• Zydelig should not be used during pregnancy. 
• Zdravila Zydelig se med nosečnostjo ne sme uporabljati.
The safety and efficacy of Zydelig in children under the age of 18 years have not been established. 
Varnost in učinkovitost zdravila Zydelig pri otrocih, starih do 18 let, še nista bili dokazani.
Patients should be advised to report new respiratory symptoms promptly. 
Bolnike je treba opozoriti, da morajo nemudoma poročati o novih respiratornih simptomih.
Tell your doctor if you have problems swallowing tablets. 
Obvestite zdravnika, če imate težave s požiranjem tablet.
One hundred and twelve (89.6%) subjects were refractory to their last regimen prior to study entry. 
Sto dvanajst (89,6 %) oseb je bilo neodzivnih na svoj zadnji režim zdravljenja pred vstopom v študijo.
If necessary, your doctor may decide to stop treatment for a while, before starting treatment again at the same or a lower dose. 
Po potrebi se lahko vaš zdravnik odloči, da za nekaj časa prekine zdravljenje, preden nadaljuje z zdravljenjem z enakim ali nižjim odmerkom.
DOR was a secondary endpoint and was defined as the time from the first documented response (CR, PR, or MR) to the first documentation of disease progression or death from any cause. 
DOR je bil sekundarni opazovani dogodek, opredeljen kot čas od prvega dokumentiranega odgovora (CR, PR ali MR) do prvega dokumentiranega napredovanja bolezni ali smrti zaradi katerega koli razloga.
Any grade 
Katera koli stopnja
Keep the bottle and this leaflet with you so that you can easily describe what you have taken. 
Plastenko in ta navodila za uporabo imejte s seboj, da boste znali opisati, kaj ste vzeli.
Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment. 
Laboratorijske preiskave lahko pokažejo zvišanje vrednosti belih krvničk (ki se jim reče „limfociti”) v vaši krvi v prvih nekaj tednih zdravljenja.
What Zydelig is and what it is used for 
Kaj je zdravilo Zydelig in za kaj ga uporabljamo
Most frequently observed were infections in the respiratory system and septic events. 
Najbolj pogosto je bilo opaziti okužbe dihal in septične dogodke.
The median time from diagnosis of CLL to randomisation was 8.5 years. 
Mediani čas od diagnoze KLL do randomizacije je bil 8,5 let.
Tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (progressive multifocal leukoencephalopathy or PML). 
Zdravnika takoj obvestite, če opazite ali če nekdo drug pri vas opazi: izgubo spomina, težave pri razmišljanju, težave pri hoji ali izgubo vida - vse to so lahko posledica zelo redke, toda resne okužbe možganov, ki je lahko smrtna (progresivne multifokalne levkoencefalopatije ali PML).
The film-coated tablet can be taken with or without food (see section 5.2). 
Filmsko obložena tableta se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
The marketing authorisation holder shall submit the first periodic safety update report for this product within 8 months following authorisation. 
Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 8 mesecih po pridobitvi dovoljenja za promet.
Alternative medicinal products, such as olanzapine, may be considered. 
Razmisli se lahko o dajanju alternativnih zdravil, kot je olanzapin.
Do not stop taking this medicine unless your doctor tells you to. 
Ne prenehajte jemati tega zdravila, razen če vam to naroči zdravnik.
The mean blood-to-plasma concentration ratio was approximately 0.5. 
Povprečno razmerje med koncentracijama v krvi in plazmi je bilo približno 0,5.
Treatment of overdose with Zydelig consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. 
Zdravljenje prevelikega odmerka z zdravilom Zydelig je sestavljeno iz splošnih podpornih ukrepov, ki vključujejo spremljanje vitalnih znakov in opazovanje kliničnega stanja bolnika.
• changes in the number of white blood cells 
• sprememba števila belih krvnih celic
Tell your doctor right away: 
Takoj povejte zdravniku:
Clinical monitoring is recommended for increased signs/symptoms of corticosteroid effects. 
Priporoča se klinično spremljanje glede povečanih znakov/simptomov učinkov kortikosteroida.
• who have received at least one prior therapy (see section 4.4), or 
• ki so se pred tem vsaj enkrat zdravili (glejte poglavje 4.4), ali
For pulmonary arterial hypertension: 
Za pljučno arterijsko hipertenzijo:
In particular, tell your doctor if you are taking any of the following: 
Zdravniku še zlasti povejte, če jemljete kaj od spodaj navedenega:
The median OS, including long-term follow-up for all 125 subjects, was 48.6 months. 
Mediani čas OS, vključno z dolgoročnim spremljanjem vseh 125 oseb, je bil 48,6 meseca.
• if you are allergic to idelalisib or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na idelalizib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Monitor ANC at least weekly. 
Spremljajte ANC najmanj enkrat tedensko.
Unmutated IGHV 
Nemutirani IGHV
SJS or TEN occurred within one month of the medicinal combination and fatal outcomes have resulted. 
SJS ali TEN sta se pojavila v enem mesecu od te kombinacije zdravil in prišlo je do smrtnih izidov.
Zydelig may be used for the treatment of two different cancers in adults: 
Zdravilo Zydelig se lahko uporablja za zdravljenje dveh različnih vrst raka pri odraslih:
Malformations were observed at exposures from 12 times the human exposure based on AUC. 
Deformacije so opazili pri izpostavljenostih, ki so bile od 12-krat večje kot je izpostavljenosti človeka na podlagi AUC.
• if you have any other medical conditions or illness (especially an infection or fever) 
• če imate kakšno drugo bolezen (zlasti okužbo ali povišano telesno temperaturo).
The apparent volume of distribution for idelalisib (mean) was approximately 96 L. 
Navidezni volumen porazdelitve za idelalizib (povprečni) je bil približno 96 l.
Peeling away of the skin may lead to serious infection. 
Luščenje kože lahko povzroči resno okužbo.
Table 7: Summary of efficacy in Study 101-09 (IRC assessment) Characteristic 
Preglednica 7: Povzetek učinkovitosti v študiji 101-09 (ocena IRC) Značilnost
However, your doctor may reduce this dose to 100 mg twice a day if you experience particular side effects. 
Vendar pa lahko vaš zdravnik ta odmerek zmanjša na 100 mg dvakrat na dan, če se pojavijo določeni neželeni učinki.
FL subset (N=72) n (%) 
Podskupina FL (N = 72) n (%)
** LNR defined as the proportion of subjects who achieved a ≥ 50% decrease in the sum of products of the greatest perpendicular diameters of index lesions. 
** Vrednost LNR je opredeljena kot delež oseb, ki so dosegle ≥ 50 % zmanjšanje vsote zmnožkov največjih navpičnih premerov indikacijskih lezij.
Nearly all (95.9%) subjects had received prior anti-CD20 monoclonal antibodies. 
Skoraj vse (95,9 %) osebe so pred tem prejemale monoklonska protitelesa proti CD20.
The carcinogenicity potential of idelalisib was evaluated in a 26-week transgenic RasH2 mouse study and a 2-year rat study. 
Kancerogeni potencial idelaliziba so ocenili v 26-tedenski študiji na transgenih miših RasH2 in 2-letni študiji na podganah.
Patients should be instructed to swallow the tablet whole. 
Bolnikom je treba naročiti, da naj pogoltnejo celo tableto.
Grade ≥ 3 
≥ 3. stopnja
Each carton contains 1 bottle. 
Ena škatla vsebuje 1 plastenko.
Subjects had a median CIRS score of 4. 
Osebe so imele mediani rezultat CIRS 4.
Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms. 
Zdravniki morajo upoštevati PML pri postavljanju diferencialne diagnoze pri bolnikih, pri katerih se novi nevrološki, kognitivni ali vedenjski znaki ali simptomi pojavijo ali poslabšajo.
Your doctor may also decide to permanently stop treatment with Zydelig. 
Vaš zdravnik se bo morda odločil celo za trajno prekinitev zdravljenja z zdravilom Zydelig.
It is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method as a second form of contraception. 
Trenutno ni znano, ali lahko idelalizib zmanjša učinkovitost hormonskih kontraceptivov, zato morajo ženske, ki uporabljajo hormonske kontraceptive, dodati pregradno metodo kot drugo obliko kontracepcije.
Idelalisib is not considered to have broad immunosuppressive activity. 
Smatrajo, da idelalizib nima široke imunosupresivne aktivnosti.
If you are currently breast-feeding, talk to your doctor before starting treatment. 
Če trenutno dojite, se pred začetkom zdravljenja pogovorite z zdravnikom.
This observed lymphocytosis is a pharmacodynamic effect and should not be considered progressive disease in the absence of other clinical findings. 
Ta opažena limfocitoza je farmakodinamični učinek in naj se brez prisotnosti drugih kliničnih rezultatov ne šteje za progresivno bolezen.
The median OS, including long-term follow-up for all FL subjects was 61.2 months. 
Mediani čas OS, vključno z dolgoročnim spremljanjem vseh oseb s FL, je bil 61,2 meseca.
Concentration monitoring of sedatives/hypnotics is recommended and dose reduction may be considered. 
Priporoča se spremljanje koncentracij sedativov/hipnotikov in razmisli se lahko o zmanjšanju odmerka.
This is to check that you do not have an infection, that your liver is working properly, and that your blood counts are normal. 
Z njimi bodo preverjali, ali imate morda kakšno okužbo, ali jetra pravilno delujejo in ali imate normalno krvno sliko.
• if you have shortness of breath or difficulty breathing 
• če imate kratko sapo ali težave z dihanjem.
Alternatively, switching to pravastatin, rosuvastatin, or pitavastatin may be considered. 
Alternativno se lahko razmisli o prehodu na pravastatin, rosuvastatin ali pitavastatin.
• Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well. 
• Zaradi zdravila Zydelig lahko postanejo kontracepcijska "tabletka" in vsajeni hormonski kontraceptivi manj učinkoviti.
Women using hormonal contraceptives should add a barrier method as a second form of contraception since it is currently unknown whether idelalisib may reduce the effectiveness of hormonal contraceptives. 
Ženske, ki uporabljajo hormonske kontraceptive, morajo dodati pregradno metodo kot drugo obliko kontracepcije, saj trenutno ni znano, ali lahko idelalizib zmanjša učinkovitost hormonskih kontraceptivov.
The following pack size is available: outer carton containing 1 plastic bottle of 60 film-coated tablets. 
Na voljo je naslednja velikost pakiranja: zunanja škatla, ki vsebuje 1 plastenko s 60 filmsko obloženimi tabletami.
For subjects in the placebo + R group, the summary includes data up to the first dosing of idelalisib in an extension study. 
Za osebe v skupini placebo + R vključuje povzetek podatke do prvega odmerjanja idelaliziba v podaljšani študiji.
There have been cases of PJP after stopping idelalisib treatment. 
Obstajajo primeri PJP po prenehanju zdravljenja z idelalizibom.
Your doctor will check your blood counts before or during treatment with Zydelig and in rare cases they may need to give you another medicine. 
Vaš zdravnik bo preveril vaše krvne vrednosti pred zdravljenjem z zdravilom Zydelig in med njim; v redkih primerih vam bo morda moral dati drugo zdravilo.
Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8. 
Osebe so imele mediani rezultat skupne ocene bolezni (CIRS-Cumulative Illness Rating Scale) 8.
In vitro, the CYP3A4 inhibition was irreversible, and return to normal enzyme activity is therefore expected to take several days after stopping idelalisib administration. 
In vitro je bilo zaviranje CYP3A4 ireverzibilno, zato se pričakuje, da bo vrnitev na normalno encimsko aktivnost trajala več dni po prenehanju dajanja idelaliziba.
Women of childbearing potential / contraception 
Ženske v rodni dobi / kontracepcija
Severe skin blistering conditions have been reported in some people who have received Zydelig while also receiving other medicines known to cause these potentially life-threatening conditions. 
Poročali so o stanjih s hudimi kožnimi mehurji pri nekaterih ljudeh, ki so prejemali zdravilo Zydelig sočasno z drugimi zdravili, za katera je znano, da povzročajo ta življenjsko ogrožajoča stanja.
Clinical monitoring is recommended and a lower starting dose of atorvastatin may be considered. 
Priporoča se klinično spremljanje in lahko se razmisli o nižjem začetnem odmerku atorvastatina.
Nearly all PJP infections, including fatal cases, occurred in the absence of PJP prophylaxis. 
Skoraj do vseh okužb s PJP, vključno s smrtnimi primeri, je prišlo ob odsotnosti profilakse za PJP.
Reproductive and developmental toxicity 
Toksičnost za razmnoževanje in razvoj
The plasma exposures (Cmax and AUC) of idelalisib are approximately dose proportional between 50 mg and 100 mg and less than dose proportional above 100 mg. 
Izpostavljenosti idelalizibu v plazmi (Cmax in AUC) sta približno sorazmerni z odmerkom med 50 mg in 100 mg in manj kot sorazmerni z odmerkom nad 100 mg.