natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - ORAL SOLUTION 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - PERORALNA RAZTOPINA
The demonstration of the benefit of Ziagen is mainly based on results of studies performed in adult treatment-naïve patients using a regimen of Ziagen 300 mg twice daily in combination with zidovudine and lamivudine. 
V teh študijah je bil uporabljen režim odmerjanja zdravila Ziagen v odmerku 300 mg dvakrat na dan, v kombinaciji z zidovudinom in lamivudinom.
Each ml of oral solution contains 20 mg of abacavir (as sulfate). 
Vsak ml peroralne raztopine vsebuje 20 mg abakavirja (v obliki sulfata).
What you need to know before you take Ziagen 
Kaj morate vedeti, preden boste vzeli zdravilo Ziagen Ne uporabljajte zdravila Ziagen:
Ziagen should not be administered to patients with end-stage renal disease (see section 5.2). 
Zdravila Ziagen ne smemo dajati bolnikom v končnem stadiju ledvične odpovedi (glejte poglavje 5.2).
ACTG5095 was a randomised (1:1:1), double-blind, placebo-controlled trial performed in 1147 antiretroviral naïve HIV-1 infected adults, comparing 3 regimens: zidovudine (ZDV), lamivudine (3TC), abacavir (ABC), efavirenz (EFV) vs ZDV/3TC/EFV vs ZDV/3TC/ABC. 
Primerjali so 3 režime zdravljenja: zidovudin (ZDV), lamivudin (3TC), abakavir (ABC), efavirenz (EFV) proti ZDV/3TC/EFV oziroma proti ZDV/3TC/ABC.
In a separate study comparing the unblinded NRTI combinations (with or without blinded nelfinavir) in children, a greater proportion treated with abacavir and lamivudine (71%) or abacavir and zidovudine (60%) had HIV-1 RNA ≤400 copies/ml at 48 weeks, compared with those treated with lamivudine and zidovudine (47%)[ p=0.09, intention to treat analysis]. 
zdravljeni z abakavirjem in lamivudinom (71 %) ali abakavirjem in zidovudinom (60 %), večji kot pri skupini, zdravljeni z lamivudinom in zidovudinom (47 %) [p = 0,09, analiza ITT].
The recommended dose of Ziagen is 600 mg daily. 
Priporočeni odmerek zdravila Ziagen znaša 600 mg na dan. Priporočeni odmerek se lahko jemlje kot
Triple nucleoside therapy 
Zdravljenje s kombinacijo treh nukleozidov
This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1). 
Priporočeni odmerek zdravila Ziagen znaša 600 mg (30 ml) na dan. Priporočeni odmerek se lahko jemlje kot 300 mg (15 ml) dvakrat na dan ali kot 600 mg (30 ml) enkrat na dan (glejte poglavji 4.4 in
Induction of hepatic metabolism has not been observed in clinical studies. 
V kliničnih študijah niso zasledli indukcije jetrnih encimov.
• if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - such as Triumeq, Trizivir or Kivexa) or any of the other ingredients of this medicine (listed in Section 6) 
Triumeq, Trizivir ali Kivexa) ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6),
How to store Ziagen 
Shranjevanje zdravila Ziagen
Very rarely, patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again. 
Zelo redko so se preobčutljivostne reakcije pojavile pri bolnikih, ki so znova začeli jemati zdravila, ki vsebujejo abakavir, pa niso imeli prej, preden so ga prenehali jemati, nobenih preobčutljivostnih simptomov.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TABLET BLISTER FOIL TEXT 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Anyone taking Ziagen could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Ziagen. 
Preobčutljivostna reakcija na abakavir se lahko pojavi vsakomur, ki jemlje zdravilo Ziagen, in je lahko življenjsko nevarna, če ne prenehajo jemati zdravila Ziagen.
Management of ABC HSR reaction 
Obvladovanje preobčutljivostnih reakcij na ABC
The safety and efficacy of Ziagen has not been established in patients with significant underlying liver disorders. 
Pri bolnikih s hudimi motnjami v delovanju jeter, varnost in učinkovitost zdravila Ziagen nista bili dokazani.
No dosage adjustment of Ziagen is necessary in patients with renal dysfunction. 
Za bolnike z motnjami v delovanju ledvic ni treba prilagajati odmerkov.
For general Ziagen information enquiries, contact GlaxoSmithKline….Tel …………… (local company name and telephone number will be inserted here). 
Za vsa splošna vprašanja o zdravilu Ziagen pokličite GlaxoSmithKline …………Tel……………….
Delay in stopping treatment with Ziagen after the onset of hypersensitivity may result in a life-threatening reaction. 
Ziagen, ko se pojavi preobčutljivost, lahko povzroči življenjsko nevarne reakcije.
Remove the bottle cap. Keep it safely. 
Shranite ga na varnem.
Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa, Triumeq and Trizivir). 
Zdravilo Ziagen vsebuje abakavir (ki je tudi zdravilna učinkovina zdravil Kivexa, Triumeq in
Similarly, greater proportions of children treated with the abacavir containing combinations had HIV-1 RNA ≤50 copies/ml at 48 weeks (53%, 42% and 28% respectively, p=0.07). 
Podobno je imel večji delež otrok zdravljenih s kombinacijami z abakavirjem < 50 kopij/ml HIV-1 RNA v 48. tednu
• Ziagen must be stopped without delay, even in the absence of the HLA-B*5701 allele, if an HSR is suspected. 
HSR, tudi ob odsotnosti alela HLA-B*5701.
A randomised comparison of a regimen including once daily vs twice daily dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study of HIV-infected, paediatric patients. 
Režim odmerjanja abakavirja enkrat na dan podpira multicentrična, dvojno slepa, nadzorovana študija,
After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26% of subjects on the ZDV/3TC/ABC arm, 16% on the ZDV/3TC/EFV arm and 13% on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml). 
Virološki neuspeh (HIV RNA > 200 kopij/ml) je bil opažen pri 26 % oseb, ki so prejemale ZDV/3TC/ABC, 16 % oseb, ki so prejemale ZDV/3TC/EFV, in 13 % oseb, ki so prejemale 4 zdravila.
Contents of the pack and other information 
Shranjevanje zdravila Ziagen Vsebina pakiranja in dodatne informacije
Placental transfer of abacavir and/or its related metabolites has been shown to occur in human. 
Izkazalo se je, da pri ljudeh prihaja do prehoda abakavirja in/ali njemu podobnih presnovkov skozi posteljico.
If you get any symptoms of infection while you are taking Ziagen: Tell your doctor immediately. 
Če se vam med jemanjem zdravila Ziagen pojavijo simptomi okužbe:
Oral use 
Peroralna uporaba.
• stiffness in the joints 
• bolečine v želodcu,
Keep this leaflet. 
• izpuščaj na koži.
Ziagen 20 mg/ml oral solution 
Ziagen 20 mg/ml peroralna raztopina
Gastrointestinal tract 
Peroralna raztopina
Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. 
Tudi pri bolnikih, ki nimajo znanega statusa HLA-B*5701 in so v preteklosti prenašali abakavir, je priporočljivo izvesti presejanje pred ponovno uvedbo zdravljenja z abakavirjem.
If you have stopped taking Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN 
Če ste zdravilo Ziagen nehali jemati zaradi preobčutljivostne reakcije, ga ne smete vzeti NIKOLI VEČ; prav tako ne smete nikoli več vzeti kakšnega drugega zdravila, ki vsebuje abakavir (npr.
The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose ; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml. 
Farmakokinetiko abakavirja so preučevali pri bolnikih z blago jetrno okvaro (Child-Pughov ocena 5-6), ki so dobili enkratni odmerek 600 mg.
Do not take Ziagen: 
in se posvetujte glede prenehanja jemanja zdravila Ziagen, če:
Tablet Core 
PODATKI NA PRIMARNI OVOJNINI
• if you have severe kidney disease Talk to your doctor if any of these apply to you. 
Posvetujte se z vašim zdravnikom, če kaj od tega velja za vas.
• hyperactivity (excessive restlessness and movement) 
• palpitacije (hitro ali neredno bitje srca) ali tremor, • hiperaktivnost (povečan nemir in prekomerno gibanje),
Three subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48. 
mesecev, prešli s peroralne raztopine abakavirja in lamivudina dvakrat na dan na režim odmerjanja enkrat na dan. Trije preiskovanci so imeli v 48. tednu nezaznavno virusno obremenitev, eden pa je imel HIV-RNA v plazmi 900 kopij/ml.
Sorbitol 70% (E420) 
M184I (45 %).
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street 
(trading as Glaxo Wellcome Operations)
Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine. 
V jetrih nastali presnovki abakavirja se izločajo pretežno s sečem.
Sodium citrate 
Zelo redki: laktacidoza
• Children weighing at least 14 kg and less than 20 kg: The usual dose of Ziagen is 300 mg a day. 
• Otroci, ki tehtajo vsaj 14 kg in manj kot 20 kg: Običajni odmerek zdravila Ziagen je 300 mg na dan. Odmerek se lahko daje v obliki 150 mg odmerka (polovica tablete) dvakrat na dan ali po posvetu z zdravnikom v obliki 300 mg odmerka (ena cela tableta) enkrat na dan.
Package leaflet: Information for the user Ziagen 300 mg Film-coated tablets 
Navodilo za uporabo Ziagen 300 mg filmsko obložene tablete abakavir
SIDE 1 
PRILOGA III
• headache 
• driska,
Once-Versus Twice-Daily Comparison GLS Mean Ratio (90% Cl) 
Primerjava enkrat in dvakrat na dan, razmerje geometričnih sredin po metodi najmanjših kvadratov (90 % IZ)
Package leaflet: Information for the user Ziagen 20 mg/ml oral solution 
Navodilo za uporabo Ziagen 20 mg/ml peroralna raztopina abakavir
Tablet Coating 
prejetega odmerka.
• if they are overweight 
• ki imajo prekomerno telesno maso.
General disorders and administration site conditions Common: fever, lethargy, fatigue 
Pogosti: vročina, letargija, utrujenost.
A review of these data was first conducted by the PRAC. 
Pregled teh podatkov je najprej opravil odbor PRAC.
Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovakia. 
Zdravila, ki vsebujejo flupirtin, so odobrena od 80-tih let 20. stoletja in so trenutno na voljo v naslednjih državah članicah EU: v Bolgariji, Estoniji, Nemčiji, na Madžarskem, v Italiji, Latviji, Litvi, na Poljskem, Portugalskem, v Romuniji in na Slovaškem.
The other dosages and pharmaceutical forms are only available in Germany. 
Druge jakosti in farmacevtske oblike so na voljo samo v Nemčiji.
The 100-mg immediate-release capsules are available in the 11 EU Member States listed above. 
100-miligramske kapsule s takojšnjim sproščanjem so na voljo v 11 zgoraj navedenih državah članicah EU.
The opening of these channels reduces the excessive electrical activity that leads to many pain states. 
Odpiranje teh kanalčkov zmanjša čezmerno električno dejavnost, ki povzroča mnoga bolečinska stanja.
The review of flupirtine-containing medicines was initiated in March 2013 at the request of Germany, under Article 107i of Directive 2001/83/EC. 
Pregled zdravil, ki vsebujejo flupirtin, je marca 2013 sprožila Nemčija v skladu s členom 107i Direktive 2001/83/ES.
Based on the findings of this review, healthcare professionals in the EU are advised of the following updated recommendations: 
Na podlagi ugotovitev tega pregleda naj zdravstveni delavci v EU upoštevajo naslednja posodobljena priporočila:
Subsequently, multiple other actions such as muscle relaxation were identified. 
Pozneje so odkrili mnoge druge učinke, kot je mišična relaksacija.
It followed the procedural steps laid out in Article 107i of Directive 2001/83, also known as the urgent Union procedure. 
Obravnavan je bil skladno s koraki postopka, določenega v členu 107i Direktive 2001/83 in imenovanega nujni postopek Unije.
This means that it opens specific pores on the surface of nerve cells called potassium channels. 
To pomeni, da odpre specifične pore na površini živčnih celic, imenovane kalijevi kanalčki.
In particular, there was a lack of efficacy data on the use of flupirtine for longer than 8 weeks. 
Podatki o učinkovitosti so bili predvsem pomanjkljivi za uporabo flupirtina, daljšo od 8 tednov.
Flupirtine is available as 100-mg immediate-release capsules, 400-mg extended-release tablets, 75mg and 150-mg suppositories and as a solution for injection (100 mg). 
Flupirtin je na voljo v obliki 100-miligramskih kapsul s takojšnjim sproščanjem, 400-miligramskih tablet s podaljšanim sproščanjem, 75- ter 150-miligramskih svečk in raztopine za injiciranje (100 mg).
If you are taking flupirtine, your treatment should not last longer than 2 weeks. 
Če jemljete flupirtin, zdravljenje ne sme trajati več kot 2 tedna.
The PRAC concluded that the benefits of injectable flupirtine continue to outweigh their risks when used in this way. 
Odbor PRAC je zaključil, da so koristi flupirtina za injiciranje še vedno večje od njegovih tveganj, če se uporablja na ta način.
With regard to the evidence of efficacy, the review highlighted a lack of sufficient data on the benefits of flupirtine in chronic pain. 
Glede dokazov o učinkovitosti je pregled izpostavil pomanjkanje zadostnih podatkov o koristih flupirtina pri kronični bolečini.
The PRAC recommendations were sent to the CMDh, which adopted a final position. 
Priporočila odbora PRAC so bila poslana skupini CMDh, ki je sprejela končno stališče.
• You should not take flupiritine as a long-term treatment for chronic pain. 
• Flupirtina ne smete uporabljati za dolgotrajno zdravljenje kronične bolečine.
• Healthcare professionals should review the treatment of patients taking flupirtine taking into account the recommendations above. 
• Zdravstveni delavci morajo ponovno oceniti zdravljenje bolnikov, ki jemljejo flupirtin, pri čemer morajo upoštevati zgornja priporočila.
• The duration of treatment with flupirtine should not exceed 2 weeks and patients' liver function should be checked after each full week of treatment. 
• Trajanje zdravljenja s flupirtinom ne sme biti daljše od 2 tednov, delovanje bolnikovih jeter pa je treba preverjati po vsakem dopolnjenem tednu zdravljenja.
Flupirtine is a non-opioid painkiller that has been used to treat pain, such as pain associated with muscle tension, cancer pain, menstrual pain and pain following orthopaedic surgery or injuries. 
Flupirtin je neopioidni analgetik, ki se uporablja za zdravljenje bolečine, kot je npr. bolečina, povezana z mišično napetostjo, bolečina pri raku, menstruacijska bolečina in bolečina po ortopedskem kirurškem posegu ali poškodbah.
A review of the safety data from the EU adverse reaction database revealed 330 cases of adverse liver events suspected to be linked to flupirtine. 
Pregled varnostnih podatkov iz podatkovne zbirke neželenih učinkov EU je pokazal 330 primerov jetrnih neželenih dogodkov, domnevno povezanih s flupirtinom.
Doctors using the injectable flupirtine should also follow relevant advice to minimise risk to patients. 
Tudi zdravniki, ki uporabljajo flupirtin za injiciranje, morajo upoštevati zadevna priporočila za zmanjševanje tveganja pri bolnikih.
The CMDh agreed with the PRAC's conclusions and has endorsed the PRAC's recommendations on the use of flupirtine-containing medicines. 
Skupina CMDh se je strinjala z zaključki odbora PRAC in potrdila njegova priporočila glede uporabe zdravil, ki vsebujejo flupirtin.
The PRAC also reviewed the available data on the benefits of flupirtine and concluded that, while there were data from studies in the treatment of acute pain, there were insufficient data to support its use in the treatment of long-term pain. 
Odbor PRAC je prav tako pregledal razpoložljive podatke o koristih flupirtina in sklenil, da kljub podatkom iz študij zdravljenja akutne bolečine ni zadostnih podatkov, ki bi podprli njegovo uporabo pri zdravljenju dolgotrajne bolečine.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority new recommendations to restrict the use of oral flupirtine medicines and suppositories. 
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je 26. junija 2013 večinsko potrdila nova priporočila za omejitev uporabe peroralnih zdravil in svečk, ki vsebujejo flupirtin.
Flupirtine was first introduced as an alternative painkiller to opioids and NSAIDs. 
Flupirtin so prvič uvedli kot alternativni analgetik opioidom in nesteroidnim protivnetnim zdravilom.
• Because flupirtine may have effects on the liver in some patients, your doctor will test your liver function during treatment and stop treatment if there are any signs of liver problems. 
• Ker ima lahko flupirtin pri nekaterih bolnikih učinke na jetra, bo zdravnik med zdravljenjem preveril delovanje vaših jeter in prekinil zdravljenje, če bodo prisotni kakršni koli znaki težav z jetri.
In addition to oral medicines and suppositories, this review also covered injectable flupirtine medicines which were being given as a single injection for pain following surgery. 
Poleg peroralnih zdravil in svečk je ta pregled vključil tudi zdravila s flupirtinom za injiciranje, ki so se dajala v obliki enkratnega injiciranja proti pooperativni bolečini.
The recommendations follow a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked into reported liver problems with flupirtine, ranging from high liver-enzyme levels to liver failure. 
Priporočila temeljijo na pregledu, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila in se je osredotočil na težave z jetri (od povišanih ravni jetrnih encimov do jetrne odpovedi), o katerih so poročali v zvezi s flupirtinom.
If you have been taking flupirtine for longer than 2 weeks you will need to get your treatment reviewed by your doctor or pharmacists. 
Če flupirtin jemljete več kot 2 tedna, se o tem posvetujte z zdravnikom ali farmacevtom.
These medicines should now only be used for treating acute (short-term) pain in adults who cannot use other painkillers, such as non-steroidal anti-inflammatory drug (NSAIDs) and weak opioids, and treatment should not last longer than 2 weeks. 
Ta zdravila se smejo uporabljati samo za zdravljenje akutne (kratkotrajne) bolečine pri odraslih, ki ne morejo uporabljati drugih protibolečinskih zdravil, kot so nesteroidna protivnetna zdravila in šibki opioidi, zdravljenje pa ne sme trajati dlje kot 2 tedna.
The events ranged from asymptomatic increases in liver enzymes to liver failure. 
Dogodki so obsegali od asimptomatskega povečanja ravni jetrnih encimov do jetrne odpovedi.
In addition, patients' liver function should be checked after each full week of treatment and treatment should be stopped if the patient has any signs of liver problems. 
Poleg tega je treba v času zdravljenja vsak teden preveriti delovanje bolnikovih jeter in prekiniti zdravljenje, če ima bolnik kakršne koli znake težav z jetri.
• Treatment must be stopped in any patient with abnormal liver function tests results or symptoms of liver disease. 
• Zdravljenje je treba prekiniti pri vsakem bolniku z nenormalnimi izvidi preiskav jetrnega delovanja ali simptomi bolezni jeter.
As the CMDh position was adopted by majority it will be sent to the European Commission, which will take a legally binding position throughout the EU. 
Ker je skupina CMDh to stališče sprejela z večino, je bilo poslano Evropski komisiji, ki ga je potrdila in sprejela končni pravno zavezujoči sklep, veljaven v celotni EU.
Flupirtine must also not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems. 
Flupirtin se prav tako ne sme uporabljati pri bolnikih z obstoječo jetrno boleznijo ali težavami z zlorabo alkohola ali pri bolnikih, ki jemljejo druga zdravila, za katera je znano, da povzročajo težave z jetri.
Flupirtine works as a ‘selective neuronal-potassium-channel opener'. 
Flupirtin deluje kot „selektivni odpiralec kalijevih kanalčkov v živčnih celicah“.
• Flupirtine must not be used in patients with pre-existing liver disease or alcohol abuse problems or in patients taking other medicines known to cause liver problems. 
• Flupirtin se ne sme uporabljati pri bolnikih z obstoječo jetrno boleznijo ali težavami z zlorabo alkohola ali pri bolnikih, ki jemljejo druga zdravila, za katera je znano, da povzročajo težave z jetri.
• If you are being treated with flupirtine and have any questions or concerns about your treatment, 
• Če se zdravite s flupirtinom in imate kakršna koli vprašanja ali pomisleke v zvezi z zdravljenjem, se posvetujte z zdravnikom ali farmacevtom.
The PRAC evaluated the available data on liver safety, noting that there were no cases of liver failure or liver transplantation reported in patients who took the medicine for 2 weeks or less. 
Odbor PRAC je ocenil razpoložljive podatke o varnosti za jetra, pri čemer je ugotovil, da pri bolnikih, ki so zdravilo jemali 2 tedna ali manj, niso poročali o nobenem primeru jetrne odpovedi ali presaditve jeter.
• Oral flupirtine medicines and suppositories should only be used to treat adults with acute pain and only if treatment with other painkillers (such as NSAIDs and weak opioids) is contraindicated. 
• Peroralna zdravila in svečke, ki vsebujejo flupirtin, se smejo uporabljati samo za zdravljenje odraslih z akutno bolečino in samo kadar so drugi analgetiki (kot so nesteroidna protivnetna zdravila in šibki opioidi) kontraindicirani.
• Oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who cannot use other painkillers (such as NSAIDs and weak opioids). 
• Peroralna zdravila in svečke, ki vsebujejo flupirtin, se smejo uporabljati samo za zdravljenje akutne (kratkotrajne) bolečine pri odraslih, ki ne morejo uporabljati drugih protibolečinskih zdravil (kot so nesteroidna protivnetna zdravila in šibki opioidi).
The CMDh position will now be sent to the European Commission, which will take a legally binding decision to be valid throughout the EU. 
Stališče skupine CMDh je bilo poslano Evropski komisiji, ki ga je potrdila in dne 5. septembra 2013 sprejela končni pravno zavezujoči sklep, ki velja za celotno EU.
No cases of liver failure or liver transplantation were reported in patients who took the medicine for 2 weeks or less. 
Pri bolnikih, ki so zdravilo jemali 2 tedna ali manj, niso poročali o nobenem primeru jetrne odpovedi ali presaditve jeter.
Restrictions in the use of flupirtine-containing medicinesCMDh endorses PRAC recommendation 
Omejitve pri uporabi zdravil, ki vsebujejo flupirtin
The European Commission issued a decision on 31 October 2013. 
Evropska komisija je izdala sklep 31. oktobra 2013.
The companies that market these medicines are Novartis group of companies and associated companies. 
Družbe, ki tržijo ta zdravila, so skupina Novartis in povezane družbe.
The package leaflet was amended accordingly. 
Navodilo za uporabo je bilo ustrezno spremenjeno.
They are also used to treat autoimmune diseases. 
Prav tako se uporabljata za zdravljenje avtoimunskih bolezni.
The Committee also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.5 (interactions with other medicines) and 4.6 (use in pregnancy and breast feeding). 
Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (posebna opozorila in previdnostni ukrepi), 4.5 (medsebojno delovanje z drugimi zdravili) in 4.6 (uporaba med nosečnostjo in dojenjem).