natgillin/translations-raw huggingface dataset:
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance 
kot monoterapija - pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso) nezadostno nadzorovanih z dieto in gibanjem, pri katerih je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren.
Before you start taking Pioglitazone Teva Pharma you will have a blood sample taken to check your liver function. 
Pred začetkom jemanja zdravila Pioglitazon Teva Pharma vam bodo odvzeli vzorec krvi, da se preveri delovanje vaših jeter.
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva Pharma. 
Običajno lahko še naprej jemljete druga zdravila medtem ko se zdravite z zdravilom Pioglitazon Teva Pharma.
It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately. 
Je antidiabetično zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni) pri odraslih, ko metformin ni primeren ali ne deluje na ustrezen način.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Teva Pharma and insulin experienced the development of heart failure. 
Nekateri bolniki z dolgotrajno sladkorno boleznijo tipa 2 in srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z zdravilom Pioglitazon Teva Pharma in insulinom so doživeli razvoj srčnega popuščanja.
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Teva Pharma. 
Obstaja povečana možnost zanositve, ker lahko spet pride do ovulacije, ko ste vzeli zdravilo Pioglitazon Teva Pharma.
Pioglitazone Teva Pharma with food and drink You may take your tablets with or without food. 
Zdravilo Pioglitazon Teva Pharma skupaj s hrano in pijačo Tablete lahko zaužijete s hrano ali brez nje.
This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision. 
Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ne bo vplivalo na vašo sposobnost vožnje ali upravljanja strojev, vendar bodite pozorni če imate motnje vida.
- The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate. 
- Druge pomožne snovi so manitol, hidroksipropilceluloza, kalcijev karmelozat in magnezijev stearat.
In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged >65 years compared with those less than 65 years (9.7% compared to 4.0%). 
V tej študiji so pri bolnikih, ki so se zdravili s pioglitazonom in z insulinom, večji odstotek srčnega popuščanja opazili pri bolnikih, starih 65 let in starejših, v primerjavi z bolniki, mlajšimi od 65 let (9,7 % v primerjavi s 4,0 %).
Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups. 
Biotransformacija Pioglitazon je podvržen obsežni jetrni presnovi s hidroksilacijo alifatskih metilenskih skupin.
Pioglitazone Teva Pharma has no or negligible influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Pioglitazon Teva Pharma nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
What Pioglitazone Teva Pharma is and what it is used for What you need to know before you take Pioglitazone Teva Pharma How to take Pioglitazone Teva Pharma Possible side effects 
Kaj je zdravilo Pioglitazon Teva Pharma in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazon Teva Pharma Kako jemati zdravilo Pioglitazon Teva Pharma
The formation and presence of urinary calculi with subsequent irritation and hyperplasia was postulated as the mechanistic basis for the observed tumourigenic response in the male rat. 
Domnevali so, da je nastajanje in prisotnost kamnov v sečilih s poznejšim draženjem in hiperplazijo, predstavljalo mehansko osnovo opaženega tumorogenega odgovora pri samcih podgan.
Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren Germany 
Merckle GmbH Ludwig-Merckle Strasse 3
Pioglitazone Teva Pharma may also be used in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to insulin therapy when it fails to provide sufficient control of blood sugar. 
Zdravilo Pioglitazon Teva Pharma uporabljamo samo pri bolnikih, ki ne morejo jemati metformina, in ko zdravljenje z dieto in telesno vadbo ni uspešno pri nadzoru krvnega sladkorja.
This leaflet was last revised in {MM/YYYY}. 
Navodilo je bilo nazadnje revidirano dne mesec/LLLL
Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon 
Benigne, maligne in neopredelje ne novotvorbe (vključno s cistami in polipi) rak sečnega mehurja občasni občasni občasni občasni občasni
Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone. 
zdravljenih z metforminom (hemoglobin 3-4 % in hematokrit 3,6-4,1 % relativna znižanja), in v manjšem obsegu pri bolnikih, zdravljenih s sulfonilsečnino in insulinom (hemoglobin 1-2 % in hematokrit 1-3,2 % relativna znižanja).
Reproductive system and breast disorders erectile dysfunction common 
Motnje reproduk cije in dojk erektilna disfunkcija pogosti
In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those >65 years compared to 4.0% in patients less than 65 years. 
Pri bolnikih, ki so se zdravili samo z insulinom, brez pioglitazona, je odstotek srčnega popuščanja pri bolnikih, starih 65 let in starejših, znašal 8,2 %, pri bolnikih, mlajših od 65 let, pa 4,0 %.
How to store Pioglitazone Teva Pharma Contents of the pack and other information 
Shranjevanje zdravila Pioglitazon Teva Pharma Vsebina pakiranja in dodatne informacije
If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva Pharma. 
Če ste na posebni dieti za sladkorno bolezen, jo med jemanjem zdravila Pioglitazon Teva Pharma nadaljujte.
Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin 
Kombinacija z metforminom s sulfonilsečnino z metfor minom in sulfonilsečnino z inzulinom
4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration. 
4 Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini zdravljeni s pioglitazonom in 7400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do
MARKETING AUTHORISATION HOLDER Teva B.V. 
IMETNIK DOVOLJENJA ZA PROMET Teva B.V.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking pioglitazone. 
Rak mehurja se lahko pojavi občasno (pojavijo se lahko pri največ 1 od 100 bolnikov) pri bolnikih, ki jemljejo pioglitazon.
If you stop taking Pioglitazone Teva Pharma 
Če ste prenehali jemati zdravilo Pioglitazon Teva Pharma
14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets 50 x 1 tablets 
14 tablet 28 tablet 30 tablet 50 tablet 56 tablet 84 tablet 90 tablet 98 tablet 112 tablet 196 tablet 50 x 1 tablet
Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon 
Infekcijske in parazitske bolezni okužba zgornjih dihal pogosti pogosti pogosti pogosti pogosti bronhitis pogosti sinusitis občasni občasni občasni občasni občasni
Do not take Pioglitazone Teva Pharma - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6). 
- če ste preobčutljivi na pioglitazon ali katero koli sestavino tega zdravila (navedeno v poglavju
common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7 
pogosti pogosti pogosti pogosti pogosti povišana vrednost keratin fosfokinaze v krvi pogosti povišana vrednost laktatne dehidrogenaze občasni povišana vrednost alanin aminotransferaze7
common common uncommon macular oedema not known not known not known not known not known Ear and labyrinth disorders vertigo uncommon 
pogosti pogosti občasni makularni edem neznana neznana neznana neznana neznana
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva Pharma. 
Zdravnik vas bo v času zdravljenja z zdravilom Pioglitazon Teva Pharma naročil na redne preiskave krvi.
prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4). 
Glede na možna tveganja pri dolgotrajni terapiji, mora zdravnik potrditi pri rednih rutinskih pregledih, da je korist pioglitazona ohranjena (glejte poglavje 4.4).
‘15' on one side and ‘TEVA' on the other side. 
izbočene, z oznako »45« na eni strani in »TEVA« na drugi strani.
Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5). 
Poročali so, da sočasno dajanje pioglitazona z gemfibrozilom (zaviralec citokroma P450 2C8) ali rifampicina (induktor citokroma P450 2C8) poviša oziroma zniža plazemsko koncentracijo pioglitazona (glejte poglavje 4.5).
- The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets or 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters. 
- Tablete so na voljo v aluminij/aluminij pretisnih omotih v pakiranjih po 14, 28, 30, 50, 56, 84, 90, 98, 112 ali 196 tablet ali kot 50 x 1 tableta v aluminij/aluminij perforiranem pretisnem omotu za enkratni odmerek.
DATE OF REVISION OF THE TEXT {MM/YYYY} 
DATUM ZADNJE REVIZIJE BESEDILA
EU/1/12/758/032 
EU/1/12/758/021-030 EU/1/12/758/032
Take Pioglitazone Teva Pharma daily as prescribed. 
Če ste pozabili vzeti zdravilo Pioglitazon Teva Pharma Zdravilo Pioglitazon Teva Pharma jemljite vsak dan, kakor vam je predpisano.
Manufacturer: 
Izdelovalci
4.4 Special warnings and precautions for use 
4.4 Posebna opozorila in previdnostni ukrepi Zastajanje tekočine in srčno popuščanje
Pioglitazone Teva Pharma 15 mg tablets Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets 
Pioglitazon Teva Pharma 15 mg tablete Aluminij/aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 56, 84, 90, 98, 112 in 196 tablet.
Pioglitazone Teva Pharma should be used every day to work properly. 
Za pravilno delovanje je potrebno zdravilo Pioglitazon Teva Pharma jemanti vsak dan.
What you need to know before you take Pioglitazone Teva Pharma 
Kaj morate vedeti, preden boste vzeli zdravilo Pioglitazon Teva Pharma Ne jemljite zdravila Pioglitazon Teva Pharma
Respiratory, thoracic and mediastinal disorders dyspnoea common 
Bolezni dihal, prsnega koša in media stinalnega prostora dispneja pogosti
Immune System Disorders hypersensitivity and allergic reactions1 
- povišanje vrednosti jetrnih encimov - alergijske reakcije
- Pioglitazone Teva Pharma 45 mg tablets are white to off white, round, convex with the number ‘45' on one side and ‘TEVA' on the other side. 
- Tablete zdravila Pioglitazon Teva Pharma 15 mg so bele do umazano bele barve, okrogle, izbočene, z oznako »15« na eni strani in »TEVA« na drugi strani.
How to store Pioglitazone Teva Pharma 
Shranjevanje zdravila Pioglitazon Teva Pharma
common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) sweating tiredness increased appetite 
- vetrovi občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - sladkor v urinu, beljakovine v urinu - povišanje vrednosti encimov
No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%). 
Pri moških, zdravljenih s pioglitazonom, niso opazili povečane stopnje zlomov (1,7 %) v primerjavi s primerjalnim zdravilom
In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator. 
100 bolniških let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/905 (2,5 %; 0,5 zlomov na 100 bolniških let) žensk, zdravljenih s primerjalnim zdravilom.
If you stop using Pioglitazone Teva Pharma, your blood sugar may go up. 
Če ste prenehali jemati zdravilo Pioglitazon Teva Pharma, se vam lahko raven krvnega sladkorja zviša, zato se posvetujte z zdravnikom, preden prenehate s tem zdravljenjem.
Pioglitazone Teva Pharma 30 mg tablets Each tablet contains 30 mg of pioglitazone (as hydrochloride). 
Pioglitazon Teva Pharma 30 mg tablete Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
The other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are: 
4.3 Kontraindikacije Pioglitazon je kontraindiciran pri bolnikih:
Pioglitazone Teva Pharma 45 mg tablets Each tablet contains 45 mg of pioglitazone (as hydrochloride). 
Pioglitazon Teva Pharma 45 mg tablete Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
Pioglitazone Teva Pharma 15 mg tablets Each tablet contains 15 mg of pioglitazone (as hydrochloride). 
Pioglitazon Teva Pharma 15 mg tablete Ena tableta vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
Pioglitazone is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria 
- s preobčutljivostjo na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju - s srčnim popuščanjem ali srčnim popuščanjem v anamnezi (NYHA razredi od I do IV)
Each Pioglitazone Teva Pharma 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride). 
Ena 30-miligramska tableta Pioglitazon Teva Pharma vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida).
Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin dizziness common insomnia uncommon uncommon uncommon uncommon uncommon 
Kombinacija z metforminom s sulfonilsečnino z metfor minom in sulfonilsečnino z inzulinom kože in podkožja znojenje občasni
very common (may affect more than 1 in 10 people) - decreased blood sugar (hypoglycaemia) 
pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - glavobol - omotica - vetrovi
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
What Pioglitazone Teva Pharma looks like and contents of the pack - Pioglitazone Teva Pharma 15 mg tablets are white to off white, round, convex with the number 
- Tablete zdravila Pioglitazon Teva Pharma 30 mg so bele do umazano bele barve, okrogle,
- The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90, 
- Tablete so na voljo v aluminij/aluminij pretisnih omotih v pakiranjih po 14, 28, 30, 50, 56, 84, 90, 98, 112 ali 196 tablet.
Each Pioglitazone Teva Pharma 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride). 
Ena 45-miligramska tableta Pioglitazon Teva Pharma vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida).
MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/011-020 
EU/1/12/758/011-020 EU/1/12/758/031
Each Pioglitazone Teva Pharma 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride). 
Ena 15-miligramska tableta Pioglitazon Teva Pharma vsebuje 15 mg pioglitazona (v obliki pioglitazonijevega klorida).
common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia) 
- otopelost občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje sinusov (sinusitis)
What Pioglitazone Teva Pharma contains - The active substance is pioglitazone. 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Pioglitazon Teva Pharma - Zdravilna učinkovina je pioglitazon.
UAB “Sicor Biotech” Tel: +370 5 266 0203 
Tel: +370 5 266 0203
common 
SOB
What Pioglitazone Teva Pharma is and what it is used for 
Kaj je zdravilo Pioglitazon Teva Pharma in za kaj ga uporabljamo Zdravilo Pioglitazon Teva Pharma vsebuje pioglitazon.
Fluid retention and cardiac failure 
Srčne bolezni srčno popuščanje pogosti
The recommended starting dose is 2.5 mg once a week for 4 weeks. 
Priporočeni začetni odmerek je 2,5 mg enkrat na teden prve štiri tedne.
During treatment, monthly measurements are recommended. 
Med zdravljenjem je priporočljivo opravljati mesečne meritve.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu309708. 
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu309708.
The most significant allergic reactions include acute systemic allergic reaction, angioedema (swelling under the skin in areas such as the face, throat, arms and legs), and serum sickness (allergic reaction caused by animal proteins or serum). 
Najpomembnejše alergijske reakcije so akutna sistemska alergijska reakcija, angioedem (otekanje pod kožo na območjih, kot so obraz, grlo, roke in noge), in serumska bolezen (alergijska reakcija, ki jo povzročijo živalske beljakovine ali serum).
The European Medicines Agency therefore decided that Palynziq'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 Palynziq večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Palynziq must be used with stringent measures to manage any serious allergic reactions, especially in the first few months. 
Zdravilo Palynziq se mora uporabljati s strogimi ukrepi za obvladovanje kakršnih koli resnih alergijskih reakcij, zlasti v prvih mesecih.
Further information on Palynziq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Palynziq. 
Nadaljnje informacije o zdravilu Palynziq so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Palynziq.
The dose and frequency of injection are then increased gradually (up to a maximum dose of 60 mg once a day) to achieve adequate control of phenylalanine blood levels. 
Nato se odmerek in pogostnost vbrizgavanja postopoma povečujeta (do največjega odmerka v jakosti 60 mg enkrat na dan), da se doseže ustrezni nadzor nad ravnmi fenilalanina v krvi.
What measures are being taken to ensure the safe and effective use of Palynziq? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Palynziq?
The safety of Palynziq is considered acceptable, and important side effects such as allergic reactions are considered manageable with additional stringent measures (see below). 
Varnost zdravila Palynziq se šteje za sprejemljivo, pomembni neželeni učinki, kot so alergijske reakcije, pa veljajo za obvladljive z dodatnimi strogimi ukrepi (glej spodaj).
The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating PKU. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem fenilketonurije.
Palynziq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 January 2010. 
Zdravilo Palynziq je bilo 28. januarja 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
During the first part, all patients were given Palynziq at a dose of 20 or 40 mg for up to 13 weeks. 
V prvem delu so vsi bolniki do 13 tednov prejemali zdravilo Palynziq v odmerku 20 mg ali 40 mg.
Palynziq is available as pre-filled syringes (2.5, 10 and 20 mg) for injection under the skin. 
Zdravilo Palynziq je na voljo v napolnjenih injekcijskih brizgah (2,5 mg, 10 mg in 20 mg) za podkožno injiciranje.
As for all medicines, data on the use of Palynziq are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Palynziq stalno spremljajo.
For more information about using Palynziq, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Palynziq glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age. 
Palynziq je zdravilo, ki se uporablja za zdravljenje s fenilketonurijo (PKU) pri odraslih in mladostnikih, starejših od 16 let.
The most common side effects with Palynziq (which may affect more than 7 in 10 people) are reactions at the injection site, pain in the joints and allergic reactions. 
Najpogostejši neželeni učinki zdravila Palynziq (ki se lahko pojavijo pri največ 7 bolnikih od 10) so reakcije na mestu injiciranja, bolečina v sklepih in alergijske reakcije.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Palynziq 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 Palynziq upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Palynziq authorised in the EU? 
Zakaj je bilo zdravilo Palynziq odobreno v EU?
An overview of Palynziq and why it is authorised in the EU 
Pregled zdravila Palynziq in zakaj je odobreno v EU
The enzyme in pegvaliase is ‘pegylated' (attached to a chemical called PEG), allowing it to remain in the body and to act for longer. 
Encim v pegvaliazi je „pegiliran“ (vezan na kemikalijo, imenovano polietilenglikol), da lahko dlje ostane in deluje v telesu.
Palynziq is intended for long-term use. 
Zdravilo Palynziq je namenjeno dolgotrajni uporabi.
Side effects reported with Palynziq are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Palynziq, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Palynziq and what is it used for? 
Kaj je zdravilo Palynziq in za kaj se uporablja?
What benefits of Palynziq have been shown in studies? 
Kakšne koristi je zdravilo Palynziq izkazalo v študijah?
The company that markets Palynziq will provide information material for doctors and for patients and carers about the risk of allergic reactions with Palynziq, including how to identify them promptly and what to do in case such a reaction occurs. 
Podjetje, ki trži zdravilo Palynziq, bo priskrbelo informativno gradivo za zdravnike ter bolnike in negovalce o tveganju za alergijske reakcije pri uporabi tega zdravila, vključno s tem, kako jih prepoznati takoj in kako ravnati.