natgillin/translations-raw huggingface dataset:
Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8). 
Zdravilo Icandra se ne sme uporabljati pri bolnikih z okvaro jeter, vključno z bolniki, ki imajo pred zdravljenjem vrednosti ALT ali AST nad 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavja 4.2, 4.3 in 4.8).
Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets. 
pretisni omot iz poliklorotrifluoretilena (PCTFE)/PVC/Alu) Na voljo so v pakiranjih, ki vsebujejo po 10, 30, 60, 120, 180 ali 360 filmsko obloženih tablet, in v skupnih pakiranjih, ki vsebujejo po 120 (2 pakiranji po 60), 180 (3 pakiranja po 60) ali 360 (6 pakiranj po 60) filmsko obloženih tablet.
- Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control. 
- Zdravilo Icandra je indicirano kot del zdravljenja s trojno kombinacijo z insulinom poleg diete in telesne dejavnosti pri odraslih bolnikih, pri katerih diabetesa ni mogoče ustrezno urediti samo z metforminom in insulinom v stabilnem odmerku.
If you need to have major surgery you must stop taking Icandra during and for some time after the procedure. 
Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Eucras.
The dose of Icandra should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. 
Z odmerkom zdravila Icandra naj bolnik prejme po 50 mg vildagliptina dvakrat na dan (kar pomeni celotni dnevni odmerek 100 mg vildagliptina) in približno tolikšen odmerek metformina, kot ga je prejemal do tedaj.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Icandra. 
Svetujemo vam tudi, da ste v času jemanja zdravila Icandra posebno pozorni na pojavljanje novega mehurčastega izpuščaja ali novih razjed.
After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects. 
Pri zdravih odraslih je absolutna biološka uporabnost 500-miligramske tablete metformina približno 50-60 %.
There have been no formal interaction studies for Icandra. 
Formalnih študij medsebojnega delovanja zdravila Icandra z drugimi zdravili niso opravili.
What Icandra looks like and contents of the pack Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other. 
Icandra 50 mg/850 mg filmsko obložene tablete so rumene, ovalne tablete z oznako “NVR” na eni strani in “SEH” na drugi.
When and how to take Icandra - Swallow the tablets whole with a glass of water, - Take one tablet in the morning and the other in the evening with or just after food. 
• Eno tableto vzemite zjutraj, drugo pa zvečer s hrano ali takoj po njej.
Caution should be exercised in patients with a history of acute pancreatitis. 
Pri bolnikih z anamnezo akutnega pankreatitisa je potrebna previdnost.
Icandra 50 mg/850 mg film-coated tablets 
Icandra 50 mg/850 mg filmsko obložene tablete
Icandra 50 mg/1000 mg film-coated tablets 
Icandra 50 mg/1000 mg filmsko obložene tablete
Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Icandra should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. 
Odrasli z normalnim delovanjem ledvic (GFR ≥ 90 ml/min) Odmerek zdravila Icandra za preprečevanje hiperglikemije je treba določiti vsakemu posameznemu bolniku glede na njegovo trenutno shemo zdravljenja in njeno učinkovitost ter glede na bolnikovo prenašanje zdravljenja, pri tem pa se ne sme preseči najvišjega priporočenega dnevnega odmerka vildagliptina 100 mg. Zdravljenje z zdravilom Icandra je mogoče začeti z uporabo tablet bodisi jakosti 50 mg/850 mg ali 50 mg/1000 mg dvakrat dnevno in sicer eno tableto zjutraj, drugo pa zvečer.
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets 
Icandra 50 mg/850 mg filmsko obložene tablete Icandra 50 mg/1000 mg filmsko obložene tablete
- Each Icandra 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin). 
- Ena filmsko obložena tableta Icandra 50 mg/850 mg vsebuje 50 mg vildagliptina in 850 mg metforminijevega klorida (kar ustreza 660 mg metformina).
- Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin). 
- Ena filmsko obložena tableta Icandra 50 mg/1000 mg vsebuje 50 mg vildagliptina in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
Therefore, you should not receive Icandra for the treatment of type 1 diabetes. 
Zdravilo Icandra ni nadomestek insulina, zato zdravila Icandra ne smete prejemati za zdravljenje sladkorne bolezni tipa 1.
Talk to your doctor, pharmacist or nurse before taking Icandra if you have or have had a disease of the pancreas. 
Če imate ali ste imeli kdaj prej težave s trebušno slinavko, se pred začetkom jemaja zdravila Icandra posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Talk to your doctor, pharmacist or nurse before taking Icandra if you are taking an anti-diabetic medicine known as a sulphonylurea. 
Če jemljete antidiabetično zdravilo, ki ga imenujemo sulfonilurea, se pred začetkom jemanja zdravila Icandra posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride 
Icandra 50 mg/1000 mg filmsko obložene tablete vildagliptin/metforminijev klorid
Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride 
Icandra 50 mg/850 mg filmsko obložene tablete vildagliptin/metforminijev klorid
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride 
Icandra 50 mg/850 mg filmsko obložene tablete Icandra 50 mg/1000 mg filmsko obložene tablete vildagliptin/metforminijev klorid
Icandra 
Zdravilo Icandra
- if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. 
Če menite, da bi lahko bili alergični na karkoli od navedenega, se posvetujte z zdravnikom, preden začnete jemati zdravilo Icandra; - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
How to store Icandra 
Shranjevanje zdravila Icandra
Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin). 
Ena filmsko obložena tableta vsebuje 50 mg vildagliptina in 1000 mg metforminijevega klorida (kar ustreza 780 mg metformina).
Some patients have experienced the following side effects while taking Icandra and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating. 
• Pogosti: omotičnost, tremor, šibkost, nizka koncentracija glukoze v krvi, čezmerno znojenje.
EU/1/08/484/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/030 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/007 10 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/008 30 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/009 60 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/010 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/011 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/012 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/025 10 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/026 30 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/027 60 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/028 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/029 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/030 360 filmsko obloženih tablet (PCTFE/PVC/Alu)
EU/1/08/484/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/024 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/001 10 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/002 30 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/003 60 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/004 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/005 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/006 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/019 10 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/020 30 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/021 60 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/022 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/023 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/024 360 filmsko obloženih tablet (PCTFE/PVC/Alu)
EU/1/08/484/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/036 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/016 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/017 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/018 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/034 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/035 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/036 360 filmsko obloženih tablet (PCTFE/PVC/Alu)
EU/1/08/484/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/484/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/484/033 360 film-coated tablets (PCTFE/PVC/Alu) 
EU/1/08/484/013 120 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/014 180 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/015 360 filmsko obloženih tablet (PA/Alu/PVC/Alu) EU/1/08/484/031 120 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/032 180 filmsko obloženih tablet (PCTFE/PVC/Alu) EU/1/08/484/033 360 filmsko obloženih tablet (PCTFE/PVC/Alu)
- For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy: The starting dose of Icandra should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken. 
Z začetnim odmerkom zdravila Icandra naj bolnik prejme po 50 mg vildagliptina dvakrat na dan (kar pomeni celotni dnevni odmerek 100 mg vildagliptina) in tolikšen odmerek metformina, kot ga je prejemal do tedaj.
Hepatitis (reversible upon discontinuation of the medicinal product) Abnormal liver function tests (reversible upon discontinuation of the medicinal product) 
• zdravila za zdravljenje bolečine in vnetja (nesteroidna protivnetna zdravila in ali zaviralci
What measures are being taken to ensure the safe and effective use of Intanza? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Intanza?
Intanza contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type). 
Zdravilo Intanza vsebuje po 15 mikrogramov vsakega od različnih sevov (vrst) virusa gripe (podvrsto H1N1, A/California/7/2009, NYMC X-179A; podvrsto H3N2, A/Hong Kong/4801/2014, NYMC X-263B; in vrsto B, B/Brisbane/60/2008, sev divje vrste).
The full EPAR for Intanza 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 (EPAR) za zdravilo Intanza je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Intanza. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Intanza.
Two other studies looked at use of a lower strength in people under the age of 60. 
V preostalih dveh študijah so proučevali uporabo zdravila v nižjih jakostih pri ljudeh, mlajših od 60 let.
For more information about treatment with Intanza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Intanza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Intanza is a vaccine. 
Zdravilo Intanza je cepivo.
Other information about Intanza 
Druge informacije o zdravilu Intanza
Influenza vaccine (split virion, inactivated) 
cepivo proti gripi (z delci virionov, inaktivirano)
Intanza must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9. 
Zdravila Intanza ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilne učinkovine, katere koli druge sestavine zdravila ali snovi, ki utegnejo biti prisotne v izjemno majhnih količinah, kot so jajca (ovalbumin, kokošje beljakovine), neomicin, formaldehid ali oktoksinol 9.
The CHMP decided that Intanza's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Intanza večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching). 
Najpogostejši neželeni učinki zdravila Intanza (opaženi pri več kot 1 bolniku od 10) so glavobol, bolečine v mišicah in lokalne reakcije na mestu injiciranja (pordelost, oteklina, otrdelost kože, bolečina in srbenje).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intanza have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Intanza upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What benefit has Intanza shown during the studies? 
Kakšne koristi je zdravilo Intanza izkazalo med študijami?
People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered. 
Osebe s povišano telesno temperaturo ali akutno (kratkotrajno) okužbo cepiva ne smejo prejeti, dokler ne okrevajo.
Intanza is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease. 
Zdravilo Intanza se uporablja za cepljenje odraslih, starejših od 60 let, proti gripi, zlasti tistih, pri katerih obstaja povečano tveganje za pojav zapletov pri bolezni.
Why has Intanza been approved? 
Zakaj je bilo zdravilo Intanza odobreno?
The ability of Intanza to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people. 
Učinkovitost zdravila Intanza pri sprožanju nastanka protiteles (imunogenost) so najprej ocenili v petih glavnih študijah, v katerih je sodelovalo več kot 9 000 oseb.
The European Commission granted a marketing authorisation valid throughout the EU for Intanza on 
Evropska komisija je dovoljenje za promet z zdravilom Intanza, veljavno po vsej Evropski uniji, izdala
Intanza contains fragments from three different strains of flu virus. 
Zdravilo Intanza vsebuje delce treh različnih sevov virusa gripe.
Intanza is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system. 
Cepivo Intanza se daje kot intradermalna injekcija v zgornjo plast kože ob uporabi posebnega mikroinjekcijskega sistema.
In one study in people aged 60 years and over, Intanza was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response). 
V eni študiji pri ljudeh, starejših od 60 let, so cepivo Intanza primerjali s cepivom proti gripi, ki je vsebovalo adjuvans (spojino, ki se doda za povečanje imunskega odziva).
What is the risk associated with Intanza? 
Kakšna tveganja so povezana z zdravilom Intanza?
Intanza is a vaccine, which is available as a suspension for injection in a pre-filled syringe. 
Zdravilo Intanza je cepivo, ki je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi.
Later seasonal formulations of Intanza have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies. 
Poznejše sezonske formulacije zdravila Intanza so sprožile podobne odzive protiteles proti trem sevom gripe, vključenim v cepivo, kot so bili tisti, opaženi v glavnih študijah.
In the five original studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains. 
V petih prvotnih študijah sta zdravilo Intanza in primerjalno cepivo povzročila zadostne koncentracije protiteles, ki so potrebne za zaščito proti vsem trem sevom gripe.
The use of the vaccine should be based on 
Uporabljati se mora v skladu z
Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Intanza before the 
V zdravilo Intanza je treba pred njegovo uporabo vključiti delce virusnih sevov, za katere se glede na priporočila SZO za severno poloblo in priporočila Evropske unije (EU) predvideva, da bodo povzročali gripo v prihodnji sezoni.
How does Intanza work? 
Kako zdravilo Intanza deluje?
In all studies, Intanza was compared with another flu vaccine given by injection into a muscle. 
V vseh študijah so zdravilo Intanza primerjali z drugim cepivom proti gripi, ki je bilo injicirano v mišico.
For the full list of all side effects reported with Intanza, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Intanza,
The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards. 
da so primerjali ravni protiteles pred injiciranjem in tri tedne po njem.
Invented name Strength Pharmaceutical Form Route of Administration Packaging 
jakost farmacevtska oblika pot uporabe ovojnina
Content 
Regranex
0.01 % Gel 
0,01 % gel za dermalno uporabo tuba za večkratno odmerjanje
EU Number 
<Številka postopka EMEA> < Številka EU >
Tube (polythylene) 
< vsebina (koncentracija)>
This overview was last updated in 03-2018. 
Povzetek je bil nazadnje posodobljen marca 2018.
Further information on Ameluz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Nadaljnje informacije za zdravilo Ameluz so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Ameluz received a marketing authorisation valid throughout the EU on 14 December 2011. 
Za zdravilo Ameluz je bilo 14. decembra 2011 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of Ameluz? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ameluz?
This method of treatment involves applying a source of light to activate the medicine. 
Ta metoda zdravljenja vključuje uporabo vira svetlobe, ki sproži delovanje zdravila.
The Agency therefore concluded that the benefits of Ameluz are greater than its risks and it can be authorised. 
Agencija je zato zaključila, da so koristi zdravila Ameluz večje od z njim povezanih tveganj in da se lahko odobri.
This kills the cells by reacting with and destroying their components, such as proteins and DNA. 
To celice uniči, saj reagira z njihovimi sestavnimi deli, kot so beljakovine in DNK.
Ameluz (5-aminolaevulinic acid) 
Ameluz (5-aminolevulinska kislina)
An overview of Ameluz and why it is authorised in the EU 
Pregled zdravila Ameluz in zakaj je odobreno v EU
Other information about Ameluz 
Druge informacije o zdravilu Ameluz
Ameluz is available as a gel (78 mg/g) to be applied to the skin. 
Zdravilo Ameluz je na voljo kot gel (78 mg/g), ki se nanese na kožo.
Why is Ameluz authorised in the EU? 
Zakaj je bilo zdravilo Ameluz odobreno v EU?
As for all medicines, data on the use of Ameluz are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ameluz stalno spremljajo.
The main measure of effectiveness in all studies was the total number of patients whose actinic keratoses or cancer lesions had all cleared up three months after the last treatment. 
Glavno merilo učinkovitosti v vseh študijah je bilo skupno število bolnikov, pri katerih so vse aktinične keratoze ali rakave lezije izginile v treh mesecih po zadnjem zdravljenju.
What benefits of Ameluz have been shown in studies? 
Kakšne koristi je zdravilo Ameluz izkazalo v študijah?
The European Medicines Agency concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative. 
Evropska agencija za zdravila je zaključila, da so koristi zdravljenja z zdravilom Ameluz večje od maloštevilnih in večinoma blagih neželenih učinkov ter da je bilo zdravilo Ameluz učinkovitejše in nekoliko varnejše kot standardno zdravljenje.
What are the risks associated with Ameluz? 
Kakšna tveganja so povezana z zdravilom Ameluz?
Actinic keratoses are skin growths caused by exposure to sunlight, which can lead to skin cancer. 
Aktinične keratoze so kožne rašče, ki jih povzroča izpostavljenost sončni svetlobi, kar lahko povzroči kožnega raka.
What is Ameluz and what is it used for? 
Kaj je zdravilo Ameluz in za kaj se uporablja?
It must not be used in people who have porphyria (an inability to break down chemicals called porphyrins) or people who have certain skin diseases caused by exposure to light. 
Ne sme se uporabljati pri osebah s porfirijo (nezmožnostjo razgradnje kemičnih snovi, imenovanih porfirini) in osebah z nekaterimi kožnimi boleznimi, ki jih povzroča izpostavitev svetlobi.