natgillin/translations-raw huggingface dataset:
Glidipion should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). 
Zdravilo Glidipion se ne sme uporabljati pri bolnikih na dializi (tehniki čiščenja krvi, uporabljeni pri bolnikih z obolenjem ledvic).
EPAR summary for the public 
Povzetek EPAR za javnost pioglitazon
Therefore, the CHMP's view was that, as for Actos, the benefits outweigh the identified risks. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Actos, odtehtajo znana tveganja.
Glidipion is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable. 
Zdravilo Glidipion se uporablja samostojno pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primerno.
Why has Glidipion been approved? 
Zakaj je bilo zdravilo Glidipion odobreno?
Glidipion can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy'). 
Lahko se uporablja tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni), če metformin ni primeren (zdravljenje z dvema zdraviloma).
Glidipion can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin. 
Lahko pa se uporablja tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana zgolj z insulinom in za katere metformin ni primeren.
Glidipion can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy'). 
Zdravilo Glidipion se lahko uporablja tudi skupaj z metforminom in sulfonilsečnino hkrati pri bolnikih, pri katerih nadzor ni zadosten kljub dvojnemu peroralnemu zdravljenju (zdravljenje s tremi zdravili).
What is Glidipion used for? 
Za kaj se zdravilo Glidipion uporablja?
How does Glidipion work? 
Kako zdravilo Glidipion deluje?
How has Glidipion been studied? 
Kako je bilo zdravilo Glidipion raziskano?
What is Glidipion? 
Kaj je zdravilo Glidipion?
How is Glidipion used? 
Kako se zdravilo Glidipion uporablja?
Severe humoral or cellular (primary or acquired) immunodeficiency, e.g. severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4). 
Huda humoralna ali celična (primarna ali pridobljena) imunska pomanjkljivost, npr. huda kombinirana imunska pomanjkljivost, agamaglobulinemija in AIDS ali simptomatska okužba s HIV ali za starost specifični odstotek CD4+ T-limfocitov pri otrocih mlajših od 12 mesecev: CD4+ < 25 %; pri otrocih med 12 in 35 mesecev: CD4+ < 20 %; pri otrocih med 36 in 59 mesecev: CD4+ < 15 % (glejte poglavje 4.4).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before the vaccination is given. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali s farmacevtom, preden boste prejeli to cepivo.
Whether you or your child receives the vaccine will depend upon the level of your immune defenses. 
Ali boste vi ali vaš otrok prejeli cepivo, je odvisno od stopnje vašega imunskega odziva.
You or your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness (see section 2 “Do not use [PRODUCT NAME]”) 
Vas ali vašega otroka je treba pozorno spremljati, ker odziv na cepljenje morda ne bo zadosten, da bi bila zagotovljena zaščita pred boleznijo (glejte poglavje 2 "Cepiva [IME CEPIVA] ne smete prejeti")
- if you or your child has any illness (such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)) or takes any medicine that weakens the immune system. 
- če imate vi ali vaš otrok kakršnokoli bolezen (kot je virus humane imunske pomanjkljivosti (HIV) ali pridobljen sindrom imunske pomanjkljivosti (AIDS)) ali jemljete kakršnakoli zdravila, ki oslabijo imunski sistem.
The wording below should be inserted: 
Vstaviti se mora spodnje besedilo:
During this time you should use an effective method of birth control to avoid pregnancy. 
V tem času morate uporabljati zanesljivo metodo kontracepcije, da preprečite nosečnost.
Even if a theoretical risk cannot be excluded yet, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with rubella containing vaccines. 
Čeprav teoretičnega tveganja še ne moremo izključiti, o nobenem primeru prirojenega sindroma rdečk niso poročali pri več kot 3500 dovzetnih ženskah, ki so bile v času cepljenja s cepivi, ki vsebujejo virus rdečk, nevede v zgodnjih fazah nosečnosti.
Warnings and precautions The text of this section should be read as follows: 
Opozorila in previdnostni ukrepi Besedilo v tem razdelku se mora glasiti:
Talk to your doctor or pharmacist before you or your child receives [PRODUCT NAME]: - if you or your child has weakened immune system (e.g. such as HIV infection). 
Posvetujte se s svojim zdravnikom, preden vi ali vaš otrok prejmete cepivo [IME CEPIVA]: - če imate vi ali vaš otrok oslabljen imunski sistem (kot je npr. okužba z virusom HIV).
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g. asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases). 
Cepljenje lahko pride v poštev pri bolnikih z določenimi imunskimi pomanjkljivostmi, kadar koristi odtehtajo tveganja (npr. bolniki z asimptomatsko okužbo s HIV, pomanjkljivost podrazreda IgG, prirojeno nevtropenijo, kronično granulomatozno boleznijo in boleznijo z okvaro komplementa).
Section 4.4 Special warnings and precautions for use The wording on pregnancy and breastfeeding should be deleted. 
Poglavje 4.4 Posebna opozorila in previdnostni ukrepi Besedilo glede nosečnosti in dojenja se mora izbrisati.
Also, it is important that you do not become pregnant within one month after having the vaccine. 
Pomembno je tudi, da ne zanosite v roku enega meseca po cepljenju.
Section 4.6 Fertility, pregnancy and lactation The wording regarding pregnancy should read as follows: 
Poglavje 4.6 Plodnost, nosečnost in dojenje Besedilo glede nosečnosti se mora glasiti:
What you need to know before you use [PRODUCT NAME] Do not use [PRODUCT NAME] 
Kaj morate vedeti, preden boste prejeli cepivo [IME CEPIVA] Cepiva [IME CEPIVA] ne smete prejeti
The wording regarding pregnancy should read as follows: “[PRODUCT NAME] should not be administrated to pregnant women. 
Besedilo glede nosečnosti se mora glasiti: “Nosečnic se ne sme cepiti s cepivom [IME CEPIVA].
Pregnant women should not be vaccinated with [PRODUCT NAME]. 
Nosečnic se ne sme cepiti s cepivom [IME CEPIVA].
Section 4.3 Contraindications The wording regarding pregnancy and immunocompromised patients should read as follows: 
Poglavje 4.3 Kontraindikacije Besedilo glede nosečnosti in imunsko oslabelih bolnikov se mora glasiti:
Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 
Poleg tega ženska 1 mesec po cepljenju ne sme zanositi (glejte poglavje 4.6).
The wording regarding pregnancy and immunocompromised patients should read as follows: 
Besedilo glede nosečnosti in imunsko oslabelih bolnikov se mora glasiti:
In case of inadvertent vaccination of pregnant women with [PRODUCT NAME], this should not be a reason for termination of pregnancy. 
V primeru nenamernega cepljenja nosečnice s cepivom [IME CEPIVA] to ne sme biti razlog za prekinitev nosečnosti.
Pregnancy should be avoided for 1 month following vaccination. 
Ženska ne sme zanositi 1 mesec po cepljenju.
These patients should be monitored carefully for signs of parotitis. 
Te bolnike je treba pozorno spremljati glede znakov parotitisa.
These patients should be monitored carefully for signs of measles, parotitis, rubella and varicella. 
Te bolnike je treba pozorno spremljati glede znakov ošpic, parotitisa, rdečk in noric.
These patients should be monitored carefully for signs of measles, parotitis and rubella. 
Te bolnike je treba pozorno spremljati glede znakov ošpic, parotitisa in rdečk.
These patients should be monitored carefully for signs of measles. 
Te bolnike je treba pozorno spremljati glede znakov ošpic.
In addition, pregnancy should be avoided for 1 month following vaccination. 
Poleg tega 1 mesec po cepljenju ne smete zanositi.
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles in case of contact, despite appropriate vaccine administration. 
Pri bolnikih z oslabelo imunostjo, ki nimajo kontraindikacij za cepljenje s tem cepivom (glejte poglavje 4.3), odziv morda ne bo tako dober kot pri imunskokompetentnih osebah.
However, fetal damage has not been documented when mumps vaccines have been given to pregnant women. 
Vendar pri uporabi cepiva proti mumpsu pri nosečnicah, niso zabeležili poškodb ploda.
Therefore, inadvertent vaccination of unknowingly pregnant women with measles, mumps and rubella containing vaccines should not be a reason for termination of pregnancy. 
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo viruse ošpic, mumpsa in rdečk, ne sme biti razlog za prekinitev nosečnosti.
However, fetal damage has not been documented when measles, mumps, rubella or varicella vaccines have been given to pregnant women. 
Vendar pri uporabi cepiva proti ošpicam, mumpsu, rdečkam ali noricam pri nosečnicah, niso zabeležili poškodb ploda.
Amendments to be included in the relevant sections of the package leaflet for multivalent measles, mumps and rubella containing vaccines 2. 
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za večvalentna cepiva, ki vsebujejo ošpice, mumps in rdečke 2.
Amendments to be included in the relevant sections of the package leaflet for monovalent mumps containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za enovalentna cepiva, ki vsebujejo mumps
Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles, mumps and rubella containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za večvalentna cepiva, ki vsebujejo ošpice, mumps in rdečke
Amendments to be included in the relevant sections of the summary of product characteristics for monovalent mumps containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za enovalentna cepiva, ki vsebujejo mumps
However, fetal damage has not been documented when measles, mumps or rubella vaccines have been given to pregnant women. 
Vendar pri uporabi cepiva proti ošpicam, mumpsu ali rdečkam pri nosečnicah, niso zabeležili poškodb ploda.
Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles, mumps, rubella and varicella containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za večvalentna cepiva, ki vsebujejo ošpice, mumps, rdečke in norice
Therefore, inadvertent vaccination of unknowingly pregnant women with mumps containing vaccines should not be a reason for termination of pregnancy. 
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virus mumpsa, ne sme biti razlog za prekinitev nosečnosti.
Therefore, inadvertent vaccination of unknowingly pregnant women with measles containing vaccines should not be a reason for termination of pregnancy. 
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virus ošpic, ne sme biti razlog za prekinitev nosečnosti.
Amendments to be included in the relevant sections of the package leaflet for multivalent measles and rubella containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za večvalentna cepiva, ki vsebujejo ošpice in rdečke
Amendments to be included in the relevant sections of the package leaflet for multivalent measles, mumps, rubella and varicella containing vaccines 2. 
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za večvalentna cepiva, ki vsebujejo ošpice, mumps, rdečke in norice 2.
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets 
Popravki ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
However, fetal damage has not been documented when measles vaccines have been given to pregnant women. 
Vendar pri uporabi cepiva proti ošpicam pri nosečnicah, niso zabeležili poškodb ploda.
Amendments to be included in the relevant sections of the summary of product characteristics for monovalent measles containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za enovalentna cepiva, ki vsebujejo ošpice
Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles and rubella containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za večvalentna cepiva, ki vsebujejo ošpice in rdečke
However, fetal damage has not been documented when rubella vaccines have been given to pregnant women. 
Vendar pri uporabi cepiva proti noricam pri nosečnicah, niso zabeležili poškodb ploda.
However, fetal damage has not been documented when measles or rubella vaccines have been given to pregnant women. 
Vendar pri uporabi cepiva proti ošpicam ali rdečkam pri nosečnicah, niso zabeležili poškodb ploda.
Amendments to be included in the relevant sections of the package leaflet for monovalent measles containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za enovalentna cepiva, ki vsebujejo ošpice
Therefore, inadvertent vaccination of unknowingly pregnant women with measles and rubella containing vaccines should not be a reason for termination of pregnancy. 
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virusa ošpic in rdečk, ne sme biti razlog za prekinitev nosečnosti.
Amendments to be included in the relevant sections of the package leaflet for monovalent rubella containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za enovalentna cepiva, ki vsebujejo rdečke
Therefore, inadvertent vaccination of unknowingly pregnant women with rubella containing vaccines should not be a reason for termination of pregnancy. 
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virus rdečk, ne sme biti razlog za prekinitev nosečnosti.
Amendments to be included in the relevant sections of the summary of product characteristics for monovalent rubella containing vaccines 
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za enovalentna cepiva, ki vsebujejo rdečke
Further information on Betaferon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/betaferon. 
Nadaljnje informacije o zdravilu Betaferon so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/betaferon.
What measures are being taken to ensure the safe and effective use of Betaferon? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Betaferon?
In the other study, no delay in the time to disability progression was seen. 
V drugi študiji do odloga napredovanja invalidnosti ni prišlo.
Other information about Betaferon 
Druge informacije o zdravilu Betaferon
The European Medicines Agency decided that Betaferon's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Betaferon večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Betaferon is used in patients: 
Zdravilo Betaferon se uporablja pri bolnikih:
Betaferon received a marketing authorisation valid throughout the EU on 30 November 1995. 
Za zdravilo Betaferon je bilo 30. novembra 1995 izdano dovoljenje za promet, veljavno po vsej EU.
Side effects are common at the beginning of treatment but usually decrease with further treatment. 
Neželeni učinki so pogosti na začetku zdravljenja, vendar se z nadaljevanjem zdravljenja običajno zmanjšajo.
As for all medicines, data on the use of Betaferon are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Betaferon stalno spremljajo.
What are the risks associated with Betaferon? 
Kakšna tveganja so povezana z zdravilom Betaferon?
What benefits of Betaferon have been shown in studies? 
Kakšne koristi zdravila Betaferon so se pokazale v študijah?
• who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), in patients with at least two relapses within the last two years; 
• ki imajo vrsto multiple skleroze, znano kot „recidivno-remitentna“, pri kateri ima bolnik napade (recidive) med obdobji brez simptomov (remisije), in sicer pri bolnikih z vsaj dvema recidivoma v zadnjih dveh letih;
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Betaferon 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 Betaferon upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
In both studies, Betaferon showed a reduction (30%) in the number of clinical relapses. 
V obeh študijah je zdravilo Betaferon pokazalo (30-odstotno) zmanjšanje števila kliničnih recidivov.
• who have experienced the signs of MS for the first time, and these are severe enough to need treatment with injected corticosteroids (anti-inflammatory medicines). 
• pri katerih so se znaki multiple skleroze pojavili prvič, pri čemer so ti dovolj resni, da jih je treba zdraviti z injiciranjem kortikosteroidov (protivnetnih zdravil).
Why is Betaferon authorised in the EU? 
Zakaj je bilo zdravilo Betaferon odobreno v EU?
Betaferon must not be used in patients who have severe depression or have thoughts of suicide. 
Zdravilo Betaferon se ne sme uporabljati pri bolnikih, ki imajo hudo depresijo ali samomorilne misli.
Betaferon treatment should be stopped in patients whose condition does not improve. 
Zdravljenje z zdravilom Betaferon je treba prekiniti pri bolnikih, katerih stanje se ne izboljšuje.
An overview of Betaferon and why it is authorised in the EU 
Pregled zdravila Betaferon in zakaj je odobreno v EU
Side effects reported with Betaferon are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Betaferon, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day. 
Zdravljenje je treba začeti z odmerkom 62,5 mikrogramov (četrtina odmerka) vsak drug dan, ki se 19 dni postopoma povečuje, da se doseže priporočeni odmerek 250 mikrogramov vsak drugi dan. Bolniki si lahko po opravljenem ustreznem usposabljanju zdravilo Betaferon injicirajo sami.
Betaferon must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately). 
Ne sme uporabljati pri bolnikih, ki imajo dekompenzirano bolezen jeter (poškodovana jetra, ki ne morejo več ustrezno delovati).
For more information about using Betaferon, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Betaferon glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Betaferon is a medicine used to treat adults who have multiple sclerosis (MS). 
Betaferon je zdravilo, ki se uporablja za zdravljenje odraslih z multiplo sklerozo (MS).
The active substance in Betaferon is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks. 
Učinkovina v zdravilu Betaferon je beljakovina interferon beta-1b, ki je ena od skupin interferonov, ki jih lahko telo naravno ustvari v boju proti virusom in drugim napadom.
The most frequent side effects with Betaferon are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection. 
Najpogostejši neželeni učinki zdravila Betaferon so gripi podobni simptomi (vključno s povišano telesno temperaturo, mrzlico, bolečinami v sklepih, slabim počutjem, potenjem, glavobolom in bolečinami v mišicah) in reakcije na mestu injiciranja.
• who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active. 
• s sekundarno progresivno multiplo sklerozo (vrsto multiple skleroze, ki nastopi po recidivnoremitentni multipli sklerozi), če je njihova bolezen aktivna.
The exact way that Betaferon works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS. 
Natančen način delovanja zdravila Betaferon še ni znan, vendar se zdi, da učinkovina, interferon beta-1b, umirja imunski sistem in preprečuje recidive multiple skleroze.
What is Betaferon and what is it used for? 
Kaj je zdravilo Betaferon in za kaj se uporablja?
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them. 
Pri multipli sklerozi imunski sistem (naravni obrambni mehanizmi telesa) ne deluje pravilno in napada dele osrednjega živčnega sistema (možgane, hrbtenjačo in optični živec [živec, ki pošilja signale od očesa do možganov]), kar povzroča vnetje, ki poškoduje živce in njihovo ovojnico.
Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27. 
Zdravilo Betaferon je bilo pri zmanjševanju števila recidivov na leto učinkovitejše od placeba: bolniki, ki so prejemali zdravilo Betaferon, so imeli povprečno 0,84 recidiva na leto, medtem ko so jih bolniki, ki so prejemali placebo, imeli 1,27.
It is given by injection under the skin. 
Zdravilo se injicira v podkožje.
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. 
Multipla skleroza je bolezen, pri kateri zaradi vnetja pride do poškodbe zaščitne ovojnice okoli živcev (demielinizacije) in samih živcev.
One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%). 
Ena od obeh študij je pokazala znaten odlog napredovanja invalidnosti (31-odstotno zmanjšanje tveganja ob jemanju zdravila Betaferon) in nastopa stopnje invalidnosti, pri kateri bolnik potrebuje invalidski voziček (39 %).
Betaferon can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS. 
Predpisovanje in izdaja zdravila Betaferon je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.