natgillin/translations-raw huggingface dataset:
Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Zentiva. 
Študije o koristih in tveganjih obeh učinkovin pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Truvada, zato jih ni treba ponoviti za zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva.
If patients with HIV1 infection need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately. 
Če morajo bolniki, okuženi z virusom HIV-1, prekiniti jemanje bodisi emtricitabina bodisi tenofovirja oziroma je treba njune odmerke spremeniti, morajo jemati zdravila, ki ločeno vsebujejo emtricitabin ali tenofovirdizoproksil.
Side effects reported with Emtricitabine/Tenofovir disoproxil Zentiva are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Emtricitabin/dizoproksiltenofovirat Zentiva, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva have also 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 Emtricitabin/dizoproksiltenofovirat Zentiva upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Emtricitabine/Tenofovir disoproxil Zentiva and why it is authorised in the EU 
Pregled zdravila Emtricitabin/dizoproksiltenofovirat Zentiva in zakaj je odobreno v EU
What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Zentiva? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emtricitabin/dizoproksiltenofovirat Zentiva?
As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Zentiva are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Emtricitabin/dizoproksiltenofovirat Zentiva stalno spremljajo.
This means that Emtricitabine/Tenofovir disoproxil Zentiva contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada. 
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Truvada.
Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine (200 mg) and tenofovir disoproxil (245 mg). 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva vsebuje dve učinkovini, emtricitabin (200 mg) in dizoproksiltenofovirat (245 mg).
Emtricitabine/Tenofovir disoproxil Zentiva is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se uporablja v kombinaciji z vsaj enim drugim zdravilom proti virusu HIV za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Zentiva. 
Kot to velja za vsako zdravilo, je podjetje zagotovilo študije o kakovosti zdravila Emtricitabin/dizoproksiltenofovirat Zentiva.
Emtricitabine/Tenofovir disoproxil Zentiva is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP). 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se uporablja tudi kot pomoč pri preprečevanju spolno prenosljive okužbe z virusom HIV-1 pri odraslih in mladostnikih, pri katerih je tveganje za okužbo veliko (predekspozicijska profilaksa oziroma PrEP).
For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Zentiva, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level. 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva, ki se uporablja za zdravljenje okužbe z virusom HIV-1 v kombinaciji z vsaj enim drugim zdravilom proti okužbi z virusom HIV, zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
Emtricitabine/Tenofovir disoproxil Zentiva does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
For more information about using Emtricitabine/Tenofovir disoproxil Zentiva, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Emtricitabin/dizoproksiltenofovirat Zentiva glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. 
Emtricitabin in tenofovir podobno zavirata delovanje reverzne transkriptaze, tj. encima, ki ga tvori virus HIV, s katerim lahko ta okuži celice ter tvori še več virusov.
The company that markets Emtricitabine/Tenofovir disoproxil Zentiva will provide an information pack to doctors, which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Zentiva on kidney function, and information about use in adults for pre-exposure prophylaxis. 
Podjetje, ki trži zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva, bo pripravilo informacijsko gradivo za zdravnike, ki bo vključevalo opis možnih škodljivih učinkov tega zdravila na delovanje ledvic in informacije o njegovi uporabi za predekspozijsko profilakso pri odraslih.
Emtricitabine/Tenofovir disoproxil Zentiva is available as tablets. 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva je na voljo v obliki tablet.
What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Zentiva? 
Kakšne so koristi in tveganja, povezani z zdravilom Emtricitabin/dizoproksiltenofovirat Zentiva?
Emtricitabine/Tenofovir disoproxil Zentiva can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection. 
Predpisovanje in izdaja zdravila Emtricitabin/dizoproksiltenofovirat Zentiva je le na recept, zdravljenje z njim pa mora uvesti zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir. 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva vsebuje dve učinkovini: emtricitabin, ki je nukleozidni zaviralec reverzne transkriptaze, in dizoproksiltenofovirat, ki je „predzdravilo“ tenofovirja.
Other information about Emtricitabine/Tenofovir disoproxil Zentiva 
Druge informacije o zdravilu Emtricitabin/dizoproksiltenofovirat Zentiva
What is Emtricitabine/Tenofovir disoproxil Zentiva and what is it used for? 
Kaj je zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva in za kaj se uporablja?
Why is Emtricitabine/Tenofovir disoproxil Zentiva authorised in the EU? 
Zakaj je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva odobreno v EU?
Emtricitabine/Tenofovir disoproxil Zentiva (emtricitabine / tenofovir disoproxil) 
Emtricitabin/dizoproksiltenofovirat Zentiva (emtricitabin/dizoproksiltenofovirat)
Therefore, the Agency's view was that, as for Truvada, the benefits of Emtricitabine/Tenofovir disoproxil Zentiva outweigh the identified risks and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Emtricitabin/dizoproksiltenofovirat Zentiva, enako kot pri zdravilu Truvada, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Zentiva in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus. 
Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva naj bi pri predekspozicijski profilaksi pred okužbo z virusom HIV-1 po pričakovanjih v primeru izpostavljenosti posameznika virusu preprečilo razmnoževanje in širjenje virusa z mesta okužbe.
How is Emtricitabine/Tenofovir disoproxil Zentiva used? 
Kako se zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva uporablja?
How has Emtricitabine/Tenofovir disoproxil Zentiva been studied? 
Kako je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva raziskano?
How does Emtricitabine/Tenofovir disoproxil Zentiva work? 
Kako zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva deluje?
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN
1 Previously known as Nymusa. 
1 Prej znano kot Nymusa.
The name of the medicine was changed to Peyona on 24 November 2010. 
Ime zdravila je bilo 24. novembra 2010 spremenjeno v Peyona.
Peyona caffeine citrate 
Peyona kofein citrat
The main measure of effectiveness in this review was the number of patients who did not have ‘treatment failure'. 
Glavno merilo učinkovitosti v tej recenziji je bilo število bolnikov brez „neuspešnega zdravljenja“.
The European Commission granted a marketing authorisation valid throughout the European Union for Nymusa on 02 July 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Nymusa, veljavno po vsej Evropski uniji, izdala 2. julija 2009.
What measures are being taken to ensure the safe and effective use of Peyona? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Peyona?
This study looked at how long the babies survived and whether or not they had neurological disabilities after 18 months. 
V tej študiji so proučevali, kako dolgo so novorojenčki preživeli in ali so po 18 mesecih imeli nevrološke okvare.
Primary means that the apnoea has no obvious cause. 
Izraz „primarna“ pa pomeni, da za apnejo ni očitnega vzroka.
This reduces the effect of adenosine, stimulating the brain to resume breathing. 
To zmanjša učinek adenozina in stimulira možgane, da se dihanje ponovno začne.
Other information about Peyona 
Druge informacije o zdravilu Peyona
This is a summary of the European public assessment report (EPAR) for Peyona. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Peyona.
The doctor will stop treatment with Peyona when the baby has five to seven consecutive days without apnoea attacks. 
Zdravnik bo zdravljenje z zdravilom Peyona prekinil, ko bo novorojenček pet do sedem zaporednih dni brez napadov apneje.
For more information about treatment with Peyona, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Peyona preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Peyona shown during the studies? 
Kakšne koristi je zdravilo Peyona izkazalo med študijami?
A baby was considered to be in treatment failure if there was no halving of the number of apnoea episodes, if the baby required a machine to assist in breathing or if the baby did not survive. 
Zdravljenje je veljalo za neuspešno, če se pri novorojenčku število epizod apneje ni prepolovilo, če je ta potreboval aparat za pomoč pri dihanju ali če ni preživel.
Because caffeine citrate has been used in premature babies for a long time, the company presented information from the scientific literature. 
Ker se kofein citrat že dolgo uporablja pri nedonošenčkih, je družba predstavila podatke iz strokovne literature.
Caffeine citrate is an ‘antagonist' of adenosine, a substance that blocks the activity of some parts of the brain, including the part responsible for controlling breathing. 
Kofein citrat je „antagonist“ adenozina, snovi, ki zavira dejavnost določenih delov možganov, vključno z delom, ki je odgovoren za nadzor dihanja.
In the large published study, 46% of babies given placebo (431 out of 932) died or had neurological disabilities compared with 40% of babies given caffeine citrate (377 out of 937). 
V večji objavljeni študiji je 46 % novorojenčkov, ki so prejeli placebo (431 otrok od 932), umrlo ali imelo nevrološke posledice, med novorojenčki, ki so prejeli kofein citrat, pa je bilo takih 40 % (377 otrok od 937).
When judged necessary, the doctor may monitor the level of caffeine in the baby's blood and adjust the dose accordingly. 
Zdravnik se lahko po potrebi odloči nadzirati ravni kofeina v krvi novorojenčka in skladno z njimi prilagajati odmerke.
The summary of opinion of the Committee for Orphan Medicinal Products for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Peyona je na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
A risk management plan has been developed to ensure that Peyona is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Peyona je bil pripravljen načrt obvladovanja tveganj.
Apnoea in newborns is the cessation of breathing for more than 20 seconds. 
Apneja pri nedonošenčkih je prekinitev v dihanju za dlje kot 20 sekund.
For the full list of all side effects and restrictions with caffeine citrate, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi kofein citrata glejte navodilo za uporabo.
The active substance in Peyona, caffeine citrate, is a stimulant of the nervous system. 
Zdravilna učinkovina v zdravilu Peyona, kofein citrat, je spodbujevalec živčnega sistema.
Because the number of patients with primary apnoea of premature newborns is low, the disease is considered ‘rare', and Peyona was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 February 2003. 
Ker je nedonošenčkov s primarno apnejo malo, velja ta bolezen za redko, zato je bilo zdravilo Peyona 17. februarja 2003 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja za zdravljenje redkih bolezni).
The most common side effects with caffeine citrate (seen in between 1 and 10 patients in 100) are hyperglycaemia (high blood glucose levels), tachycardia (rapid heartbeat) and phlebitis (inflammation of a vein) and inflammation at the site of infusion. 
Najpogostejši neželeni učinki kofein citrata (opaženi pri 1 do 10 bolnikih od 100) so hiperglikemija (visoke koncentracije glukoze v krvi), tahikardija (pospešen srčni utrip) in flebitis (vnetje vene) ter vnetje na mestu infundiranja.
Apnoea in premature babies is due to the baby's breathing centres in the brain not being fully developed. 
Do apneje pri nedonošenčkih pride zato, ker dihalni centri v njihovih možganih še niso povsem razviti.
The full EPAR for Peyona can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila Peyona je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness was based on the reduction by at least a half in the daily number of apnoea episodes over ten days. 
Glavno merilo učinkovitosti je bilo zmanjšanje števila dnevnih epizod apneje v desetih dneh za vsaj polovico.
Treatment is started with a dose of 20 mg per kilogram bodyweight given once by slow infusion over 30 minutes. 
Začetni odmerek znaša 20 mg na kg telesne mase, odmerjen s počasno 30-minutno infuzijo.
What is the risk associated with Peyona? 
Kakšna tveganja so povezana z zdravilom Peyona?
In addition, more babies who were given caffeine citrate had at least eight days with no apnoea: 22% of babies given caffeine citrate compared with none of babies who were given placebo. 
Poleg tega je bilo več novorojenčkov, ki so prejeli kofein citrat, vsaj osem dni brez apneje: 22 % novorojenčkov, ki so prejeli kofein citrat, v primerjavi z nobenim novorojenčkom, ki je prejel placebo.
The CHMP decided that Peyona's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Peyona večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Peyona is a solution for infusion (drip) into a vein that contains the active substance caffeine citrate (20 mg/ml). 
Zdravilo Peyona je raztopina za infundiranje (kapalno infuzijo v veno), ki vsebuje zdravilno učinkovino kofein citrat (20 mg/ml).
Caffeine citrate works in apnoea by blocking the receptors that adenosine normally attaches to. 
Kofein citrat pri apneji deluje tako, da zavira receptorje, na katere se adenozin običajno veže.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Peyona. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In six out of ten days caffeine citrate was more effective than placebo in reducing the number of apnoea episodes by at least a half. 
V šestih dneh od desetih je bil kofein citrat učinkovitejši od placeba pri zmanjševanju števila epizod apneje za vsaj polovico.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Peyona, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Treatment with the medicine should only take place in an intensive care unit for newborns that is well equipped for monitoring the baby. 
Zdravljenje z zdravilom mora potekati izključno na oddelku intenzivne nege za novorojenčke, na katerem so na voljo ustrezni pripomočki za spremljanje novorojenčka.
Why has Peyona been approved? 
Zakaj je bilo zdravilo Peyona odobreno?
Treatment with Peyona should only be started under the supervision of a doctor experienced in treating newborn babies requiring intensive care. 
Zdravljenje z zdravilom Peyona je treba začeti pod nadzorom zdravnika z izkušnjami v intenzivni negi novorojenčkov.
In a published review of five studies, caffeine and theophylline (another stimulant) were compared with placebo in 192 premature babies with apnoea. 
V objavljeni recenziji petih študij so kofein in teofilin (drug spodbujevalec) primerjali s placebom pri 192 nedonošenčkih z apnejo.
A large published study compared caffeine citrate with placebo in treating 2,006 premature babies with apnoea. 
V večji objavljeni študiji so kofein citrat primerjali s placebom pri zdravljenju 2 006 nedonošenčkov z apnejo.
In a published study involving 85 premature babies who had had several episodes of apnoea, caffeine citrate was compared with placebo (a dummy treatment). 
V objavljeni študiji s 85 nedonošenčki, ki so imeli več epizod apneje, so kofein citrat primerjali s placebom (zdravilom brez zdravilne učinkovine).
The card will contain information on how Peyona should be administered, including doses, the monitoring of plasma caffeine levels and the side effects that may occur during treatment. 
Poleg tega se bo družba, ki izdeluje zdravilo Peyona, z državami članicami dogovorila, da bo v intenzivnih enotah, v katerih se uporablja zdravilo, obešena kartica, na kateri bodo informacije o uporabi zdravila Peyona, vključno z odmerki, spremljanjem ravni kofeina v plazmi ter neželenimi učinki, do katerih lahko pride med zdravljenjem.
The solution can also be given by mouth. 
Raztopina se lahko zaužije tudi peroralno.
In the review of five studies, fewer babies treated with caffeine or theophylline had treatment failure compared with placebo. 
V recenziji petih študij je bilo zdravljenje redkeje neuspešno pri novorojenčkih, ki so se zdravili s kofeinom ali teofilinom, kot pri novorojenčkih, ki so prejeli placebo.
What is Peyona used for? 
Za kaj se zdravilo Peyona uporablja?
Caffeine citrate was more effective than placebo at treating apnoea in premature babies. 
Kofein citrat je bil za zdravljenje apneje pri nedonošenčkih učinkovitejši od placeba.
How has Peyona been studied? 
Kako je bilo zdravilo Peyona raziskano?
After 24 hours, a ‘maintenance dose' of 5 mg per kg bodyweight may be given everyday 
Po 24 urah se lahko vsak dan daje vzdrževalni odmerek v odmerku 5 mg na kg telesne mase s počasno 10-minutno infuzijo ali peroralno skozi nazogastrično cevko (cevko, speljano skozi nos v želodec).
How does Peyona work? 
Kako zdravilo Peyona deluje?
How is Peyona used? 
Kako se zdravilo Peyona uporablja?
What is Peyona? 
Kaj je zdravilo Peyona?
Peyona is used to treat primary apnoea in premature newborns. 
Zdravilo Peyona se uporablja za zdravljenje primarne apneje pri nedonošenčkih.
This advice is applicable to all indications and to all special populations. 
Ta nasvet se nanaša na vse indikacije in vse posebne populacije.
Interrupt until resolved to grade 0-1 
Prekiniti, dokler ne doseže stopnje 0-1
• blurred or double vision 
• zamegljen ali dvojni vid
• specific changes in the electrocardiogram (QT prolongation) 
• specifične spremembe v elektrokardiogramu (podaljšanje QT)
- It is important that you take all your medicine as prescribed by your doctor. 
• Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal zdravnik.
This will help reduce the likelihood that the side effect continues or becomes severe. 
To bo pomagalo zmanjšati verjetnost, da bi se neželeni učinki nadaljevali ali postali resni.
- Take the tablets morning and evening as prescribed by your doctor. 
• Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
Tell your doctor immediately if you experience any of these symptoms. 
Takoj obvestite zdravnika, če imate katerega od teh simptomov.
• Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual. 
• Slabost: če izgubite tek in če je količina hrane, ki jo zaužijete vsak dan mnogo manjša kot ponavadi.
• Fever: if you have a temperature of 38°C or greater. 
• Zvišana telesna temperatura: če imate telesno temperaturo 38 °C ali več.
• Infection: if you experience signs of infection caused by bacteria or virus, or other organisms. 
• Okužba: če imate znake okužbe, ki jo povzroči bakterija ali virus ali drugi organizmi.
Once the dose has been reduced, it should not be increased at a later time. 
Po znižanju se odmerka kasneje ne sme povečati.
Do not give capecitabine to children and adolescents. 
Otrokom in mladostnikom ne dajajte kapecitabina.
• Vomiting: if you vomit more than once in a 24-hour time period. 
• Bruhanje: če bruhate več kot enkrat v 24 urah.
Severe and/or Life-threatening (grade 3-4) or considered medically relevant 
Resni in/ali življenjsko ogrožujoči (stopnja 3-4) ali medicinsko pomembni
• If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used. 
• Če obstajajo kontraindikacije za katero od zdravil, ki se uporablja v kombinaciji, se tega zdravila ne sme uporabljati.
Hand and foot skin-reaction can lead to loss of fingerprint, which could impact your identification by fingerprint scan. 
Kožna reakcija na rokah in nogah lahko povzroči izgubo prstnih odtisov, kar bi lahko vplivalo na vašo identifikacijo s prstnimi odtisi.