natgillin/translations-raw huggingface dataset:
Further information on Semglee can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Semglee so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This means that Semglee is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
Semglee is used once a day at the same time each day. 
Zdravilo Semglee se daje enkrat dnevno, vsak dan ob istem času.
What measures are being taken to ensure the safe and effective use of Semglee? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Semglee?
Diabetes is a disease in which the level of blood sugar is high, either because the body cannot produce insulin (type 1 diabetes) or because the body does not make enough insulin or cannot use it effectively (type 2 diabetes). 
Sladkorna bolezen je bolezen, pri kateri je raven glukoze v krvi visoka, bodisi zato, ker telo ne more proizvajati insulina (sladkorna bolezen tipa 1), bodisi zato, ker telo ne proizvede dovolj insulina oziroma ga ne more učinkovito izrabiti (sladkorna bolezen tipa 2).
Patients can inject themselves with Semglee if they have been trained appropriately. 
Bolniki si lahko zdravilo injicirajo sami, če so bili za to ustrezno usposobljeni.
As for all medicines, data on the use of Semglee is continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Semglee stalno spremljajo.
Semglee (insulin glargine) EMA/57790/2018 
Semglee (insulin glargin) EMA/57790/2018
An overview of Semglee and why it is authorised in the EU 
Pregled zdravila Semglee in zakaj je odobreno v EU
However, a supportive study in 558 patients with type 1 diabetes showed Semglee and Lantus had similar effects. 
Vendar pa je podporna študija pri 558 bolnikih s sladkorno boleznijo tipa 1 pokazala, da imata zdravili Semglee in Lantus podobne učinke.
Because Semglee is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine. 
Ker je zdravilo Semglee podobno biološko zdravilo, študije o učinkovitosti in varnosti niso bile potrebne, ker sta za insulin glargin dobro raziskani.
What benefits of Semglee have been shown in studies? 
Kakšne koristi zdravila Semglee so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Semglee have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Semglee upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Semglee (insulin glargine) 
Semglee (insulin glargin)
Side effects reported with Semglee are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Semglee, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Semglee authorised in the EU? 
Zakaj je bilo zdravilo Semglee odobreno v EU?
The most common side effect with Semglee (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). 
Najpogostejši neželeni učinek zdravila Semglee (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je hipoglikemija (nizka raven glukoze v krvi).
Patients in the study had previously had their level of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled, brought under control with Lantus; continuing treatment with either Semglee or Lantus for 24 weeks indicated comparable control of HbA1c levels with both, the level changing by an average of 0.14% in patients given Semglee, and 0.11% in those given Lantus. 
Pri bolnikih, vključenih v študijo, so pred tem izmerili raven glikoziliranega hemoglobina (HbA1c), snovi, ki kaže, kako dobro je glukoza v krvi nadzorovana in ki je bila urejena z zdravilom Lantus; ob nadaljnjem 24-tedenskem zdravljenju bodisi z zdravilom Semglee bodisi z zdravilom Lantus se je pokazalo, da je raven HbA1c primerljivo dobro nadzorovana pri obeh zdravilih, pri čemer se je raven pri bolnikih, ki so prejemali zdravilo Semglee, spremenila povprečno za 0,14 %, pri tistih, ki so prejemali zdravilo Lantus, pa za 0,11 %.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Semglee has been shown to have a comparable quality, safety and effectiveness to Lantus. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Semglee po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Lantus.
Other information about Semglee 
Druge informacije o zdravilu Semglee
The reference medicine for Semglee is Lantus. 
Referenčno zdravilo za zdravilo Semglee je zdravilo Lantus.
For more information about using Semglee, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Semglee glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Semglee? 
Kakšna tveganja so povezana z zdravilom Semglee?
It is given by injection under the skin in the belly, the thigh, or the upper arm. 
Injicira se v podkožje, in sicer v trebuh, stegno ali nadlaket.
Insulin glargine, the active substance in Semglee, enters the bloodstream more slowly than human insulin after injection and so it works for longer. 
Insulin glargin, zdravilna učinkovina v zdravilu Semglee, po injiciranju vstopa v krvni obtok počasneje kot humani insulin, zato deluje dlje.
The dose of Semglee is worked out for each patient and depends on the patient's blood glucose (sugar) level and treatment with other insulin medicines. 
Odmerek zdravila Semglee se prilagodi posameznemu bolniku ter je odvisen od bolnikove ravni glukoze (sladkorja) v krvi in zdravljenja z drugimi zdravili, ki vsebujejo insulin.
What is Semglee and what is it used for? 
Kaj je zdravilo Semglee in za kaj se uporablja?
Semglee is a ‘biosimilar medicine'. 
Zdravilo Semglee je „podobno biološko zdravilo“.
Semglee is a medicine used to treat diabetes in patients from 2 years of age. 
Semglee je zdravilo za zdravljenje sladkorne bolezni pri bolnikih, starejših od dveh let.
For the full list of side effects and restrictions with Semglee, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Semglee glejte navodilo za uporabo.
Additional studies showed that Semglee is absorbed into the body in the same way as the reference medicine, Lantus, and could be considered to act similarly on blood glucose. 
Dodatne študije so pokazale, da se zdravilo Semglee absorbira v kri enako kot referenčno zdravilo Lantus, zato je mogoče predpostaviti, da podobno deluje na glukozo v krvi.
Therefore, the Agency's view was that, as for Lantus, the benefit of Semglee outweighs the identified risk and it can be authorised in the EU. 
Agencija je menila, da koristi zdravila Semglee, enako kot pri zdravilu Lantus, odtehtajo znana tveganja in se zdravilo lahko odobri za uporabo v EU.
Semglee is a replacement insulin that acts in the same way as the body's own insulin and helps glucose enter cells from the blood. 
Nadomestni insulin v zdravilu Semglee deluje enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice.
How is Semglee used? 
Kako se zdravilo Semglee uporablja?
Extensive laboratory studies comparing Semglee with Lantus have shown that insulin glargine in Semglee is highly similar to that in Lantus in terms of chemical structure, purity and biological activity. 
Obsežne laboratorijske študije, v katerih so zdravilo Semglee primerjali z zdravilom Lantus, so pokazale, da je insulin glargin v zdravilu Semglee po zgradbi, čistosti in biološkem delovanju zelo podoben insulinu glarginu v zdravilu Lantus.
Semglee is available in pre-filled disposable pens and can only be obtained with a prescription. 
Zdravilo Semglee je na voljo v obliki napolnjenih peresnikov za enkratno uporabo, predpisovanje in izdaja zdravila pa je le na recept.
Semglee can also be used with diabetes medicines taken by mouth in patients who have type 2 diabetes. 
Pri bolnikih, ki imajo sladkorno bolezen tipa 2, se lahko zdravilo Semglee uporablja sočasno s peroralnimi zdravili proti sladkorni bolezni.
How does Semglee work? 
Kako zdravilo Semglee deluje?
Date of first authorisation: 20 May 2008 Date of latest renewal: 20 May 2013 
Datum prve odobritve: 20. maj 2008 Datum zadnjega podaljšanja: 20. maj 2013
This effect continued over the observation period of up to 33 months. 
Ta vpliv se je nadaljeval med obdobjem opazovanja do 33 mesecev.
• Getting off to a good start! 
• Priprava za dober začetek
- If you have ever had an allergic reaction to latex. 
- če ste imeli kdaj alergijsko reakcijo na lateks.
Experience with exposure during the second and third trimesters is very limited. 
Izkušnje z izpostavljenostjo zdravilu v drugem in tretjem trimesečju so zelo omejene.
Component of a 3-month multipack. 
Del 3-mesečnega skupnega pakiranja.
The instructions include the following main steps: 
Navodila obsegajo naslednje korake:
- Always use a sterile (aseptic) technique as described in here. 
- Vedno uporabite sterilno (aseptično) tehniko, kot je opisano tukaj.
You will find that within a few weeks your treatment will become a natural part of your routine. 
V nekaj tednih bo zdravljenje postalo del vaše rutine.
Put the vial on the table. 
Vialo postavite na mizo.
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion. 
Na osnovi podatkov iz študij na živalih (glejte poglavje 5.3) obstaja možnost povečanega tveganja za spontani splav.
The optimal dose has not been fully clarified. 
Optimalni odmerek še ni povsem ugotovljen.
Your doctor or nurse can tell you more about this. 
Vaš zdravnik ali medicinska sestra vam lahko pove več o tem.
Subgroup analyses according to baseline factors demonstrated evidence of efficacy in all subgroups evaluated. 
Analiza podskupin glede na izhodiščne dejavnike je pokazala dokaze o učinkovitosti v vseh ocenjenih podskupinah.
You will need the medicine: 
Potrebujete zdravilo:
Start with your first injection (or your last injection if you are not a new Extavia user). 
- Začnite s prvo injekcijo (ali zadnjo injekcijo, če niste novi uporabnik zdravila Extavia).
These may be symptoms of a serious allergic reaction, which may become life threatening. 
To so lahko simptomi resne alergične reakcije, ki lahko postane življenjsko nevarna.
► Tell your doctor, if any of the above applies to you. 
► Obvestite svojega zdravnika, če karkoli od zgoraj navedenega velja za vas.
Follow-up of patients is continuing in order to provide additional data. 
Bolnike še naprej spremljajo, da bi pridobili nadaljnje podatke.
10 - Hold the vial between your thumb and fingers. 
10 -Vialo držite med palcem in drugimi prsti.
- If you have monoclonal gammopathy. 
- če imate monoklonsko gamopatijo.
This is called demyelination. 
Postopek se imenuje demielinizacija.
60% (53) of these patients returned to negative status based on the last available assessment within the 5-year period. 
60 % (53) od teh bolnikov se je v petletnem obdobju vrnilo na negativni status glede na zadnjo dostopno meritev.
Experience with other interferons suggest a potential for impairment of male and female fertility. 
Izkušnje z drugimi interferoni nakazujejo možnost okvare moške in ženske plodnosti.
- Prepare each dose only when you are ready for an injection. 
- Vsak odmerek pripravite šele, ko ste pripravljeni na injiciranje.
1 - Wash your hands thoroughly with soap and water before beginning this process. 
1 - Pred začetkom si temeljito umijte roke z milom in vodo.
Neutralising antibodies are not produced in all patients. 
Nevtralizirajoča protitelesa ne nastajajo pri vseh bolnikih.
No long-term studies have been conducted. 
Dolgoročnih študij niso izvajali.
There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “immediate” treatment. 
Podatki ne dokazujejo koristi glede napredovanja invalidnosti pri večini bolnikov, ki so prejeli “takojšnje” zdravljenje.
Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event. 
Pomembne učinke so dosegli tudi pri bolnikih z manj diseminirano in manj aktivno boleznijo v času prvega dogodka.
If more than 3 hours pass, discard the medicine and prepare a new injection. 
Če mine več kot 3 ure, zdravilo zavrzite in pripravite novo injekcijo.
If you are especially sensitive, this might influence your ability to drive or use machines. 
Če ste posebno občutljivi, lahko to vpliva na vašo sposobnost upravljanja vozil ali strojev.
No harmful effects on the breastfed newborn/infant are anticipated. 
Škodljivih učinkov na dojenega novorojenčka/otroka ni pričakovati.
This is often associated with an increase in certain blood fats (triglycerides). 
To je pogosto povezano z zvišanjem vrednosti nekaterih maščob v krvi (trigliceridov).
The length of treatment will be decided by your doctor together with you. 
Trajanje zdravljenja boste določili skupaj z zdravnikom.
The available data for the additional three years are consistent with sustained treatment efficacy of Extavia over the whole time period. 
Razpoložljivi podatki o dodatnih treh letih se skladajo s trajno učinkovitostjo zdravljenja z zdravilom Extavia v celotnem časovnem obdobju.
This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6. 
Zdravila ne smemo mešati z drugimi zdravili, razen s priloženim vehiklom, ki je omenjen v poglavju 6.6.
These blood tests will be in addition to the tests which are normally done to monitor your MS. 
Te krvne preiskave se opravijo poleg testov, ki so običajni za nadzor MS.
Moreover, an autoinjector was used by the majority of patients throughout the study. 
Poleg tega so pri večini bolnikov ves čas trajanja študije uporabili avtoinjektor.
Some analyses suggest that this effect might be more pronounced in patients with higher titre levels of neutralising activity. 
Nekatere analize kažejo, da bi bil ta učinek lahko bolj izrazit pri bolnikih z višjim titrom nevtralizirajoče aktivnosti.
Rotation Cycle 1: Upper left section of each area Rotation Cycle 2: Lower right section of each area Rotation Cycle 3: Middle left section of each area Rotation Cycle 4 Upper right section of each area Rotation Cycle 5: Lower left section of each area Rotation Cycle 6: 
Rotacijski cikel 1: Zgornji levi del vsakega predela Rotacijski cikel 2: Spodnji desni del vsakega predela Rotacijski cikel 3: Srednji levi del vsakega predela Rotacijski cikel 4: Zgornji desni del vsakega predela Rotacijski cikel 5: Spodnji levi del vsakega predela Rotacijski cikel 6: Srednji desni del vsakega predela
If you have already been using Extavia start with the area that has not been used during the last rotation cycle (i.e. the past 16 days). 
Če ste že uporabljali zdravilo Extavia, začnite s predelom, ki ga v zadnjem rotacijskem ciklusu (tj. zadnjih 16 dni) niste uporabili.
The powder should dissolve completely without shaking. 
Prašek je treba raztopiti popolnoma, brez pretresanja.
If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later. 
Če si zdravilo pozabite samoinjicirati ob določenem času, to storite takoj, ko se spomnite in nato ponovno čez 48 ur.
Note: If the solution is discoloured or contains particles, discard it and start again with a new syringe and vial from your package. 
Pozor: Če je raztopina obarvana ali vsebuje delce, jo zavrzite in postopek začnite znova z novo brizgo in novo vialo iz paketa.
Do not use this medicine if you notice it contains particles or is discoloured. 
Ne uporabljajte tega zdravila, če opazite, da vsebuje delce ali je obarvano.
4 - Where possible gently pinch the skin together around the disinfected injection site (to raise it up a little). 
4 - Kjer je mogoče, kožo okoli dezinficiranega mesta nežno stisnite (da jo nekoliko dvignete).
You should inject this medicine into the fatty layer between the skin and muscle (that is, subcutaneously, about 8 mm to 12 mm under the skin). 
To zdravilo injicirajte v maščobno plast med kožo in mišico (to je subkutano, približno 8 mm do 12 mm pod kožo).
Do not inject a double dose to make up for a forgotten individual dose. 
Ne injicirajte si dvojnega odmerka, če ste pozabili vzeti posamezen odmerek.
- Try to give yourself the injection at the same time each day. 
- Zdravilo si poskusite injicirati vedno ob istem času dneva.
The decision to continue or discontinue treatment should be based on clinical disease activity rather than on neutralising activity status. 
Odločitev o nadaljevanju ali prekinitvi zdravljenja mora temeljiti na kliničnem poteku bolezni, ne pa na prisotnosti nevtralizirajoče aktivnosti.
If clinically needed, the use of Extavia may be considered during pregnancy. 
Če je klinično potrebno, je mogoče razmisliti o uporabi zdravila Extavia v času nosečnosti.
You will also need a disposal unit for used syringes and needles. 
Potrebovali boste tudi posodo za odstranjevanje uporabljenih brizg in igel.
Talk to your doctor if you stop or wish to stop treatment. 
Pogovorite se s svojim zdravnikom, če želite prenehati z zdravljenjem.
For example, give the first injection into the right side of the abdomen, choose the left side for the second injection, then move to the right thigh for the third, and so on through the diagram until all suitable areas of the body have been used. 
Če npr. prvo injekcijo daste v desno stran trebuha, izberite za drugo injekcijo levo stran, nato za tretjo injekcijo desno stegno in tako naprej po diagramu, dokler ne uporabite na telesu vseh primernih mest.
Detailed instructions for self-injection of Extavia under the skin are provided in the Annex at the back of this leaflet. 
Podrobna navodila za samoinjiciranje zdravila Extavia pod kožo so navedena v Dodatku na hrbtni strani tega navodila.
Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections. 
Interferoni so beljakovine, ki jih proizvaja telo in pomagajo odvračati napade na imunski sistem, kot so virusne okužbe.
- Never re-use syringes or needles. 
- Brizg ali igel nikoli ne uporabite dvakrat.
- If you have had depression or are depressed or previously had thoughts of suicide. 
- če ste že imeli depresije, ste depresivni ali ste že kdaj imeli samomorilne misli.
No investigations on fertility have been conducted (see section 5.3). 
Raziskave o plodnosti niso bile izvedene (glejte poglavje 5.3).
► Talk to your doctor if you inject too much Extavia or injected too often. 
► Pogovorite se z zdravnikom, če ste injicirali preveč zdravila Extavia ali če ste ga injicirali prepogosto.
Extavia itself does not affect the heart directly. 
Samo zdravilo Extavia ne vpliva neposredno na srce.
Injection site reactions and necroses were observed less frequently in this study than in the other pivotal studies. 
Reakcije na mestu injiciranja in nekroze so v tej študiji opazili redkeje kot v drugih ključnih študijah.
The robustness of the treatment effect was also shown by the delay of progression to multiple sclerosis according to the McDonald criteria. 
Robustnost učinka zdravljenja je pokazala tudi upočasnitev napredovanja v multiplo sklerozo po merilih po McDonaldu.
However, there are some data available in adolescents aged from 12 to 17 years which suggest that the safety of Extavia in this group is the same as in adults. 
Vendar je na voljo nekaj podatkov pri mladostnikih, starih od 12 do 17 let, ki nakazujejo, da je varnost uporabe zdravila Extavia pri tej skupini bolnikov enaka kot pri odraslih.
Push the plunger to the 1 ml mark (or to the volume prescribed by your doctor). 
Bat potisnite do oznake za 1 ml (oziroma do prostornine, ki vam jo je predpisal zdravnik).
At present it is not known how long treatment with Extavia should last. 
Trenutno ni znano, kako dolgo mora trajati zdravljenje z zdravilom Extavia.
Do not push the plunger. 
Ne pritisnite bata.
The treatment effect occurred in patients at all levels of disability investigated and independent of relapse activity. 
Učinek zdravljenja se je pojavil pri bolnikih z vsemi raziskovanimi stopnjami invalidnosti in neodvisno od recidivne aktivnosti.
These symptoms may be reduced by taking paracetamol or non-steroidal antiinflammatory medicines such as ibuprofen. 
Te simptome je mogoče ublažiti z jemanjem paracetamola ali nesteroidnih protivnetnih zdravil, kot je ibuprofen.
Generally, dose titration is recommended at the start of treatment in order to increase tolerability to Extavia (see section 4.2). 
Na splošno se na začetku zdravljenja priporoča titracija odmerka, da bi povečali toleranco za zdravilo Extavia (glejte poglavje 4.2).
The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Extavia in the third year of the study. 
Ohranjen učinek zdravljenja so opažali kljub temu, da je večina bolnikov iz skupine s placebom v tretjem letu študije jemala zdravilo Extavia.
Cases of cardiomyopathy have been reported. 
Poročali so o primerih kardiomiopatije.
* produced by genetic engineering from strain of Escherichia coli. 
* Pridobljen z gensko tehnologijo iz seva bakterije Escherichia coli.
However, the long-term impact of early treatment with Extavia is unknown even in these high risk subgroups as this study was mainly designed to assess the time to CDMS rather than the long-term evolution of the disease. 
Vendar je dolgotrajen učinek zgodnjega zdravljenja z zdravilom Extavia neznan tudi pri teh podskupinah z velikim tveganjem, kajti študija je bila namenjena ocenjevanju časa do CDMS, ne pa dolgotrajnega razvoja bolezni.
Interferons have molecular weights ranging from 15,000 to 21,000 Daltons. 
Njihova molekulska masa je od 15.000 do 21.000 daltonov.
Note: Be careful not to touch the exposed end of the syringe. 
Pozor: Ravnajte previdno, da se ne dotaknete izpostavljenega dela brizge.
If you are allergic to latex, talk to your doctor before using Extavia. 
Če ste alergični na lateks, se posvetujte z zdravnikom, preden začnete uporabljati zdravilo Extavia.
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS >1 point or >0.5 point for EDSS >=6 in the previous two years) can help to identify patients with active disease. 
Te retrospektivne analize podskupin so pokazale, da lahko recidivi in izrazito napredovanje EDSS (EDSS>1 točko ali >0,5 točke pri EDSS>=6 v zadnjih dveh letih) pomagajo odkriti bolnike z aktivno boleznijo.
Pharmacotherapeutic group: Immunostimulants, interferons, ATC Code: L03AB08 
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, interferoni, oznaka ATC: L03AB08
- If you have a heart disease, the flu-like symptoms which often occur at the start of treatment may prove stressful to you. 
- Če imate bolezen srca vas bodo morda gripi podobni simptomi, ki se pogosto pojavijo ob začetku zdravljenja, močno obremenjevali.
Extavia can reduce the number and severity of the attacks, and slow the progression of disability. 
Zdravilo Extavia lahko zmanjša pogostnost in resnost napadov ter upočasni napredovanje invalidnosti.
Other things to consider when using Extavia: 
Drugi dejavniki, ki jih je treba upoštevati pri uporabi zdravila Extavia:
What Extavia is and what it is used for 
Kaj je zdravilo Extavia in za kaj ga uporabljamo
- Always place the used syringes in the proper disposal unit. 
- Rabljeno brizgo vedno spravite v ustrezno posodo za odstranjevanje.