natgillin/translations-raw huggingface dataset:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tamiflu have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tamiflu upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
As for all medicines, data on the use of Tamiflu are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tamiflu stalno spremljajo.
It can also reduce the incidence of flu in patients who had come into contact with the disease or during a pandemic. 
Prav tako lahko zmanjša pojavnost gripe pri osebah, ki so prišle v stik z boleznijo, ali med pandemijo gripe.
In adults, the duration of the illness was reduced from an average of 5.2 days for patients taking placebo, to 4.2 days for patients taking Tamiflu. 
Pri odraslih se je trajanje bolezni skrajšalo s povprečno 5,2 dneva pri bolnikih, ki so jemali placebo, na 4,2 dneva pri bolnikih, ki so jemali zdravilo Tamiflu.
Side effects reported with Tamiflu are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Tamiflu, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The medicine contains the active substance oseltamivir. 
Zdravilo vsebuje učinkovino oseltamivir.
A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with the person. 
V eni od študij so proučevali tudi uporabo zdravila Tamiflu v družinskem okolju (277 družin) za zdravljenje oseb, okuženih z gripo, in zdravljenje ali preprečevanje gripe pri osebah, ki so v stiku z okuženo osebo.
Tamiflu reduced the incidence of flu in people who had come into contact with the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 people aged between 16 and 65 years, and 548 elderly people in nursing homes). 
Zdravilo Tamiflu je zmanjšalo pojavnost gripe pri ljudeh, ki so prišli v stik z boleznijo, ko se je eden od njihovih družinskih članov okužil z virusom gripe (962 primerov), ali med epidemijo gripe (1 562 oseb, starih od 16 do 65 let, in 548 starostnikov v negovalnih domovih).
For more information about using Tamiflu, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Tamiflu glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Tamiflu authorised in the EU? 
Zakaj je zdravilo Tamiflu odobreno v EU?
The usual dose for adults and children weighing more than 40 kg is 75 mg given once a day for at least 10 days after contact with an infected person. 
Običajni odmerek za odrasle in otroke, ki tehtajo več kot 40 kg, je 75 mg enkrat na dan najmanj deset dni zapored po stiku z osebo, okuženo z gripo.
Tamiflu is an antiviral medicine used to treat or prevent influenza (flu). 
Zdravilo Tamiflu je protivirusno zdravilo, ki se uporablja za zdravljenje ali preprečevanje influence (gripe):
What benefits of Tamiflu have been shown in studies? 
Kakšne koristi je zdravilo Tamiflu izkazalo v študijah?
Oseltamivir works on the neuramidases of both influenza A (the most common type) and influenza B viruses. 
Oseltamivir deluje na nevraminidaze virusov influence A (najpogostejša vrsta) in influence B.
An overview of Tamiflu and why it is authorised in the EU 
Pregled zdravila Tamiflu in zakaj je odobreno v EU
In families with one patient who had flu, 7% of the family members in the household developed flu when receiving Tamiflu, compared with 20% of those receiving no preventative treatment. 
V družinah z enim bolnikom, obolelim za gripo, je za gripo zbolelo 7 % družinskih članov gospodinjstva, ki so jemali zdravilo Tamiflu, v primerjavi s 20 % tistih, ki niso bili deležni preventivnega zdravljenja.
• to treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community; 
• pri zdravljenju gripe se lahko uporablja pri odraslih in otrocih (vključno z donošenimi novorojenčki), ki imajo simptome gripe, kadar je virus gripe prisoten v okolici;
The active substance in Tamiflu, oseltamivir, acts on the flu virus, blocking some of the enzymes on its surface known as neuramidases. 
Učinkovina v zdravilu Tamiflu, oseltamivir, deluje na virus gripe, kar pomeni, da zavira določene encime na površini virusa, imenovane nevraminidaze.
What are the risks associated with Tamiflu? 
Kakšna tveganja so povezana z zdravilom Tamiflu?
Tamiflu reduced the duration of the illness compared with placebo (a dummy treatment) in several studies (involving 2,413 patients aged 13 years or over, 741 elderly patients aged 65 years or over and 1,033 children aged between 1 and 12 years). 
Zdravilo Tamiflu je skrajšalo trajanje bolezni v primerjavi s placebom (zdravilom brez učinkovine) v več študijah (v katerih je sodelovalo 2 413 bolnikov, starejših od 13 let, 741 starostnikov, starejših od 65 let, in 1 033 otrok, starih od 1 do 12 let).
The most common side effects with Tamiflu (seen in more than 1 patient in 10) in adults and adolescents are headache and nausea (feeling sick). 
Najpogostejša neželena učinka zdravila Tamiflu (opažena pri več kot 1 bolniku od 10) pri odraslih in mladostnikih sta glavobol in navzeja (siljenje na bruhanje).
During a flu pandemic, Tamiflu can also be used to prevent flu in babies below 1 year of age. 
Med pandemijo gripe se lahko zdravilo Tamiflu uporablja tudi za preprečevanje gripe pri dojenčkih, mlajših od enega leta.
When Tamiflu is used during a flu epidemic, it is given for up to 6 weeks. 
Kadar se zdravilo Tamiflu uporablja med epidemijo gripe, se lahko daje do šest tednov.
In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo. 
V študiji, ki je bila izvedena med epidemijo gripe, je po stiku z okuženo osebo zbolel 1 % ljudi, ki so jemali zdravilo Tamiflu, v primerjavi s 5 % oseb, ki so jemale placebo.
When used for treatment of flu, Tamiflu reduces the duration of illness in adults and children. 
Kadar se zdravilo Tamiflu uporablja za zdravljenje gripe, skrajša trajanje bolezni pri odraslih in otrocih.
Other information about Tamiflu 
Druge informacije o zdravilu Tamiflu:
• to prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community. 
• pri preprečevanju gripe se lahko uporablja pri odraslih in otrocih, starejših od enega leta, ki so bili v stiku z osebo, okuženo z gripo, in kadar je virus gripe prisoten v okolici.
In the treatment of flu, Tamiflu must be started within two days of the onset of symptoms. 
Pri zdravljenju gripe je treba zdravilo Tamiflu začeti jemati v dveh dneh po pojavu simptomov.
What is Tamiflu and what it is used for? 
Kaj je zdravilo Tamiflu in za kaj ga uporabljamo
In the prevention of flu, Tamiflu must be started within two days of contact with someone who has flu. 
Pri preprečevanju gripe je treba jemanje zdravila Tamiflu začeti v dveh dneh po stiku z osebo, okuženo z gripo.
How does Tamiflu work? 
Kako zdravilo Tamiflu deluje?
How is Tamiflu used? 
Kako se zdravilo Tamiflu uporablja?
The usual dose for adults and children weighing more than 40 kg is 75 mg given twice a day for 5 days. 
Običajni odmerek za odrasle in otroke, ki tehtajo več kot 40 kg, je 75 mg dvakrat na dan pet dni zapored Odraslim osebam z oslabljenim imunskim sistemom (naravno obrambo telesa) se zdravilo daje deset dni.
In children the most common side effects (seen in more than 1 patient in 10) are vomiting, cough and nasal congestion (a blocked nose). 
Pri otrocih so najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) bruhanje, kašelj in zamašen nos. Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Tamiflu glejte navodilo za uporabo.
Further information on Aimovig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aimovig. 
Nadaljnje informacije za zdravilo Aimovig so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/aimovig.
Most of the side effects are mild or moderate in severity. 
Večina neželenih učinkov je blagih ali zmernih.
Aimovig received a marketing authorisation valid throughout the EU on 26 July 2018. 
Za zdravilo Aimovig je bilo 26. julija 2018 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency therefore decided that Aimovig's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Aimovig večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Aimovig? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aimovig?
The recommended dose is 70 mg every 4 weeks as a single injection. 
Priporočeni odmerek je 70 mg vsake štiri tedne z eno injekcijo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aimovig have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Aimovig upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Aimovig are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Aimovig stalno spremljajo.
Some patients may benefit from a dose of 140 mg every 4 weeks, given as either a single injection of 140 mg or two injections of 70 mg. 
Nekaterim bolnikom lahko koristi odmerek 140 mg vsake štiri tedne, ki se daje z eno injekcijo 140 mg ali dvema injekcijama po 70 mg.
Side effects reported with Aimovig are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Aimovig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effects with Aimovig (which may affect up to 1 in 10 people) are reactions at the site of injection, constipation, muscle spasms and itching. 
Najpogostejši neželeni učinki zdravila Aimovig (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so reakcije na mestu injiciranja, zaprtje, mišični krči in srbenje.
By attaching to this receptor, the medicine stops CGRP from attaching to it and causing migraine. 
S pritrditvijo na ta receptor zdravilo prepreči, da bi se nanj vezal CGRP in tako povzročil migreno.
An overview of Aimovig and why it is authorised in the EU 
Pregled zdravila Aimovig in zakaj je odobreno v EU
Only patients with migraines at least 4 days a month were included in the studies as patients with less frequent migraines are not usually eligible for preventative treatment. 
V študije so bili vključeni samo bolniki z vsaj štirimi migrenskimi dnevi na mesec, saj bolniki z manj pogostimi migrenami običajno niso primerni za preventivno zdravljenje.
The active substance in Aimovig, erenumab, is a monoclonal antibody (a type of protein) designed to attach to a receptor (target) for CGRP on body's cells. 
Učinkovina v zdravilu Aimovig, erenumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo oblikovano tako, da se pritrdi na receptor (prijemališče) za CGRP na celicah v telesu.
Other information about Aimovig 
Druge informacije o zdravilu Aimovig
Aimovig is a medicine used to prevent migraine in adults who have migraines at least 4 days a month. 
Aimovig je zdravilo, ki se uporablja za preprečevanje migrene pri odraslih, ki imajo migreno vsaj štiri dni na mesec.
What benefits of Aimovig have been shown in studies? 
Kakšne koristi zdravila Aimovig so se pokazale v študijah?
For more information about using Aimovig, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Aimovig glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Aimovig authorised in the EU? 
Zakaj je bilo zdravilo Aimovig odobreno v EU?
A chemical messenger called CGRP has been shown to be involved in the development of migraine. 
Dokazali so, da pri razvoju migrene sodeluje kemični prenašalec CGRP.
What are the risks associated with Aimovig? 
Kakšna tveganja so povezana z zdravilom Aimovig?
Aimovig can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of migraine. 
Predpisovanje in izdaja zdravila Aimovig je le na recept, zdravljenje pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem migrene.
What is Aimovig and what is it used for? 
Kaj je zdravilo Aimovig in za kaj se uporablja?
For the full list of side effects and restrictions of Aimovig, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Aimovig glejte navodilo za uporabo.
Aimovig is injected under the skin using a pre-filled syringe or pen. 
Zdravilo Aimovig se injicira pod kožo z uporabo napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika.
In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo. 
V drugi študiji pri 955 bolnikih, ki so imeli migreno povprečno osem dni na mesec, so imeli bolniki, zdravljeni z zdravilom Aimovig, na mesec v povprečju od tri do štiri migrenske dni manj, bolniki, ki so jemali placebo, pa približno dva migrenska dneva manj.
In a study of 667 patients who had migraines 18 days a month on average, those treated with Aimovig had 7 fewer days with migraines per month, compared with 4 fewer days for patients on placebo. 
V študiji pri 667 bolnikih, ki so imeli migreno povprečno 18 dni na mesec, so imeli bolniki, zdravljeni z zdravilom Aimovig, na mesec sedem migrenskih dni manj, bolniki, ki so jemali placebo, pa štiri migrenske dni manj.
How is Aimovig used? 
Kako se zdravilo Aimovig uporablja?
Aimovig was shown to be effective at reducing the number of days patients have migraines. 
Dokazano je bilo, da je zdravilo Aimovig učinkovito pri zmanjševanju števila migrenskih dni pri bolnikih.
Aimovig is effective at reducing the number of days patients suffer migraines. 
Zdravilo Aimovig je učinkovito pri zmanjševanju števila migrenskih dni pri bolnikih.
How does Aimovig work? 
Kako zdravilo Aimovig deluje?
Each cycle lasts 21 days. 
Vsak cikel traja 21 dni.
Contraception (women and men) 
Kontracepcija (ženske in moški)
10.3 (5.6, NE) 
10,3 (5,6; NO)
You may need medical treatment. 
Morda boste potrebovali zdravljenje z zdravili.
For the treatment to be fully effective, it is very important not to miss a dose. 
Da bi bilo zdravljenje popolnoma učinkovito, je zelo pomembno, da ne izpustite odmerka.
Give supportive treatment. 
Dajte podporno zdravljenje.
Reactivation of latent infections has been reported. 
Poročali so tudi o ponovni aktivaciji latentnih okužb.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1388/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1388/001
5% Glucose 
5 % glukoza
• you are due to have a vaccine or you know you may need to have one in the near future 
• se boste kmalu cepili ali veste, da boste cepljenje potrebovali v bližnji prihodnosti.
These may be new symptoms or a change in your current symptoms. 
Pojavijo se vam lahko novi simptomi ali pa se spremenijo simptomi, ki jih trenutno imate.
The storage details are as follows 
Podrobnosti o shranjevanju so:
1 To ensure product stability, do not exceed specified storage durations. 
1 Da boste zagotovili stabilnost zdravila, ne prekoračite specificiranega trajanja shranjevanja.
Active severe infections (see section 4.4). 
Aktivne hude okužbe (glejte poglavje 4.4).
This is because Polivy can affect your baby's health. 
Zdravilo Polivy namreč lahko prizadene otrokovo zdravje.
This patient had three prior lines of therapy that included anti-CD20 antibodies. 
Ta bolnik je imel predhodno tri linije zdravljenja, ki so vključevale protitelesa proti CD20.
It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant. 
Pomembno je, da zdravniku pred zdravljenjem in med zdravljenjem poveste, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
The dose of this medicine depends on your body weight. 
Odmerek zdravila je odvisen od vaše telesne mase.
This is because stopping treatment may make your condition worse. 
Prenehanje zdravljenja namreč lahko poslabša vašo bolezen.
The safety and efficacy in children and adolescents less than 18 years have not been established. 
Pediatrična populacija Varnost in učinkovitost pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
Sodium chloride 9 mg/mL (0.9%) 
Natrijev klorid 9 mg/ml (0,9 %)
• memory loss, trouble speaking, difficulty walking or problems with your eyesight 
• izguba spomina, težave z govorjenjem, hojo ali vidom
The median age was 69 years (range: 30-86 years). 
Mediana starost je bila 69 let (razpon: od 30 do 86 let).
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. 
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
A risk for breast-feeding children cannot be excluded. 
Tveganja za dojene otroke ni mogoče izključiti.
Polivy will be stored by the healthcare professionals at the hospital or clinic. 
Zdravilo Polivy bodo shranjevali zdravstveni delavci v bolnišnici ali ambulanti.
Studies have not been conducted in patients who recently received live vaccines. 
Študij pri bolnikih, ki so nedavno prejeli živa cepiva, niso izvedli.
This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6. 
Zdravila se ne sme mešati ali redčiti z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
• you think you have an infection or have had long-lasting or repeated infections such as herpes (see “Infections” in section 4). 
• če menite, da imate kakšno okužbo, ali če ste v preteklosti imeli dolgotrajne ali ponavljajoče se okužbe, kot je herpes (glejte "Okužbe" v poglavju 4);
PET-CT PR required meeting both PET-CT criteria and CT criteria. 
Delni odgovor na podlagi PET-CT je zahteval tako doseganje meril PET-CT kot meril CT.
Follow applicable proper handling and disposal procedure (see section 6.6). 
Upoštevajte ustrezen postopek za ravnanje in odstranjevanje (glejte poglavje 6.6).
• discomfort or weakness. 
• nelagodje ali šibkost.
Studies in animals have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale na reproduktivno toksičnost (glejte poglavje 5.3).
Among 173 patients treated with Polivy in Study GO29365, 95 (55%) were ≥65 years of age. 
Med 173 bolniki, zdravljenimi z zdravilom Polivy v študiji GO29365, jih je 95 (55 %) imelo > 65 let.
Clinical studies of Polivy did not include sufficient numbers of patients aged ≥65 to determine whether they respond differently from younger patients. 
Klinične študije z zdravilom Polivy niso vključevale zadostnega števila bolnikov, starih 65 let ali več, da bi lahko določili, ali se odzovejo drugače od mlajših bolnikov.
MMAE does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6. 
MMAE ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6.
If primary cause is due to lymphoma, the dose of bendamustine may not need to be reduced. 
1Če je primarni vzrok posledica limfoma, zmanjšanje odmerka bendamustina morda ne bo potrebno.
The reconstituted solution and solution for infusion should not be frozen or exposed to direct sunlight. 
Rekonstituirane raztopine in raztopine za infundiranje se ne sme zamrzniti ali izpostavljati neposredni sončni svetlobi.
Human Immunodeficiency Virus (HIV) 
Virus humane imunske pomanjkljivosti (HIV)
In vitro, MMAE is moderately bound (71%-77%) to human plasma proteins. 
In vitro je MMAE zmerno (71- do 77-%) vezan na beljakovine v človeški plazmi.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you. 
Preden začnete dobivati to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
• you have ever had liver problems 
• če ste kadar koli imeli težave z jetri;
If you had any of these symptoms before treatment with Polivy, tell your doctor straight away if you notice any changes in them. 
Če ste imeli katerega od teh simptomov že pred zdravljenjem z zdravilom Polivy, zdravnika nemudoma obvestite, če opazite kakšno spremembo.
For these reasons, comparison of incidence of antibodies to polatuzumab vedotin with the incidence of antibodies to other products may be misleading. 
Zato je primerjava pojavnosti protiteles proti polatuzumabu vedotinu s pojavnostjo protiteles proti drugim zdravilom lahko zavajajoča.
Direct the stream toward the wall of the vial and not directly on the lyophilized cake. 
Usmerite curek v steno viale, ne neposredno na liofilizirano pogačo.
Reconstituted vial concentration (20 mg/mL) 
koncentracija v rekonstituirani viali (20 mg/ml)
The reconstituted product contains no preservative and is intended for single-dose only. 
Rekonstituirano zdravilo ne vsebuje konzervansov in je namenjeno samo za enkratno uporabo.
Your doctor, pharmacist or nurse will do blood tests to check for the condition. 
Zdravnik, farmacevt ali medicinska sestra vam bodo opravili preiskave krvi za preverjanje tega sindroma.
Infusion-related reactions, allergic or anaphylactic (more severe allergic) reactions can happen. 
Lahko se pojavijo reakcije, povezane z infundiranjem, alergijske ali anafilaktične (bolj hude alergijske) reakcije.
If you get any serious reaction, your doctor may stop treatment with Polivy. 
Če se pri vas pojavi resna reakcija, lahko zdravnik zdravljenje z zdravilom Polivy ustavi.
If you get infusion-related reactions or nerve damage, or if you feel tired, weak or dizzy (see section 4) do not drive, cycle or use tools or machines until the reaction stops. 
Če se vam pojavijo z infundiranjem povezane reakcije ali okvara živcev ali če ste utrujeni, šibki ali omotični (glejte poglavje 4), ne upravljajte vozil, ne kolesarite in ne uporabljajte orodij ali strojev, dokler reakcija ne mine.
Patients were stratified by duration of response to last prior treatment of ≤ 12 months or > 12 months. 
Bolnike so stratificirali glede trajanja odgovora na zadnje predhodno zdravljenje (≤ 12 mesecev ali > 12 mesecev).
Lonzastrasse CH-3930 Visp Switzerland 
CH-3930 Visp Švica
Other medicines and Polivy 
Druga zdravila in zdravilo Polivy
Pregnant women should be advised regarding risk to the foetus. 
Nosečnicam je treba svetovati glede tveganja za plod.
Determine the volume of 20 mg/mL reconstituted solution needed based on the required dose (see below): 
Potrebno količino rekonstituirane raztopine 20 mg/ml določite glede na zahtevani odmerek (glejte spodaj):
The European Medicines Agency has waived the obligation to submit results of studies with Polivy in all subsets of the paediatric population for the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Polivy za vse podskupine pediatrične populacije za zdravljenje novotvorb zrelih celic B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• feeling weak or generally unwell. 
• občutek šibkosti ali splošno slabo počutje.