FrancophonIA/ELRC3.0 huggingface dataset:
English: The second study involved 736 patients whose blood glucose was not adequately controlled by a longacting insulin such as insulin glargine with or without one or two other diabetes medicines taken by mouth.
Slovenian: V drugo študijo je bilo vključenih 736 bolnikov, pri katerih raven glukoze v krvi ni bila zadostno uravnavana z dolgodelujočim insulinom, kot je insulin glargin, ne glede na to, ali so jemali druga zdravila za peroralno uporabo za zdravljenje sladkorne bolezni ali jih niso.
English: How does Suliqua work?
Slovenian: Kako zdravilo Suliqua deluje?
English: Upon entering the study, all patients had to stop their other diabetes medicines and were given Suliqua or insulin glargine or lixisenatide, all with metformin.
Slovenian: Ob vstopu v študijo so morali vsi bolniki prenehati jemati druga zdravila za zdravljenje sladkorne bolezni in so v kombinaciji z metforminom prejeli zdravilo Suliqua ali insulin glargin ali liksisenatid.
English: It is given as an injection under the skin of the belly, the thigh or the upper arm. Suliqua is given once a day, preferably at the same time each day.
Slovenian: Zdravilo Suliqua se daje enkrat dnevno, po možnosti vsak dan ob istem času.
English: How is Suliqua used?
Slovenian: Kako se zdravilo Suliqua uporablja?
English: The most common side effect with Suliqua (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose); problems with the digestive system are common and include diarrhoea, vomiting and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinek zdravila Suliqua (ki se lahko pojavi pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
English: EU (MA) Number
Slovenian: EU (MA) številka Izmišljen o ime
English: 6 bottles Not applicable
Slovenian: 6 plastenke
English: 1 bottle Not applicable
Slovenian: 1 plastenka
English: It must also not be used in a pregnant woman.
Slovenian: Prav tako se ne sme uporabiti pri nosečnicah.
English: This will help to protect against the diseases caused by these viruses.
Slovenian: To mu bo pomagalo pri obrambi pred boleznimi, ki jih ti virusi povzročajo.
English: It must not be used in children who have severely weakened immune systems.
Slovenian: Ne sme se uporabljati pri otrocih, ki imajo zelo oslabljen imunski sistem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProQuad on 6 April 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom ProQuad, veljavno po vsej Evropski uniji, odobrila dne 6. aprila 2006.
English: Because ProQuad contains well known weakened viruses, which are already used in other vaccines, the company presented data from vaccines that are already on the market.
Slovenian: Ker cepivo ProQuad vsebuje dobro znane oslabljene viruse, ki se že uporabljajo v drugih cepivih, je družba predstavila podatke o cepivih, ki so že na trgu.
English: The full EPAR for ProQuad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo ProQuad je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This study looked at the ability of the vaccine to trigger immune responses in these age groups.
Slovenian: V tej študiji so proučevali sposobnost cepiva za sprožitev imunskega odziva v omenjenih starostnih skupinah otrok.
English: Other information about ProQuad
Slovenian: Druge informacije o zdravilu ProQuad
English: ProQuad is a vaccine.
Slovenian: Zdravilo ProQuad je cepivo.
English: This is a summary of the European public assessment report (EPAR) for ProQuad.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ProQuad.
English: The active substances are attenuated (weakened) viruses for the diseases.
Slovenian: Zdravilne učinkovine so atenuirani (oslabljeni) virusi za navedene bolezni.
English: For more information about treatment with ProQuad, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom ProQuad preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is only given under the skin in patients with low levels of platelets in the blood or other bleeding disorders, as they may experience bleeding if the vaccine is injected into a muscle.
Slovenian: Pod kožo se daje samo osebam, ki imajo nizke ravni krvnih ploščic ali druge motnje strjevanja krvi, saj lahko pride do krvavitve, če se cepivo injicira v mišico.
English: When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes defences against them.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna oslabljene viruse kot „tujke“ in proti njim vzpostavi obrambni mehanizem.
English: ProQuad is used according to official recommendations, including the number of doses and the interval between them.
Slovenian: Cepivo ProQuad se uporablja v skladu z uradnimi priporočili, kar velja tudi za število odmerkov in časovni razmik med njimi.
English: The vaccine is injected into a muscle or under the skin, preferably in the thigh in younger children and in the shoulder area in older children and adults.
Slovenian: Cepivo se injicira v mišico ali pod kožo, po možnosti v stegensko mišico pri mlajših otrocih ter v ramensko območje pri starejših otrocih in odraslih.
English: A study has also been carried out with ProQuad in 1,620 children who received the first dose at 9, 11 and 12 months of age, and the second dose three months later.
Slovenian: S cepivom ProQuad je bila izvedena tudi študija pri 1 620 otrocih, ki so prejeli prvi odmerek pri starosti 9, 11 in 12 mesecev, drugi odmerek pa tri mesece kasneje.
English: Another study also looked at the responses one year after vaccination in 2,108 children.
Slovenian: V drugi študiji so pri 2 108 otrocih proučevali tudi odzive eno leto po cepljenju.
English: In the future, the immune system will be able to respond more quickly when it is exposed to the viruses again.
Slovenian: Ob ponovni izpostavitvi virusom v prihodnosti se bo imunski sistem hitreje odzval nanje.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ProQuad.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo ProQuad, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: However, children who received the first dose at nine months of age had a lower immune response against measles.
Slovenian: Vendar pa so otroci, ki so prvi odmerek prejeli v 9. mesecu starosti, imeli manjši imunski odziv proti ošpicam.
English: What benefit has ProQuad shown during the studies?
Slovenian: Kakšne koristi je zdravilo ProQuad izkazalo med študijami?
English: The CHMP decided that ProQuad's benefits are greater than its risks and recommended that it be given marketing authorisation for use in children above 12 months of age, noting that a second vaccination against chickenpox should be given for full protection against the disease.
Slovenian: CHMP je zaključil, da so koristi cepiva ProQuad večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet za uporabo pri otrocih, starejših od 12 mesecev, pri čemer je proti noricam potreben drugi odmerek cepiva, da se zagotovi popolna zaščita proti tej bolezni.
English: The most common side effect with ProQuad (seen in more than 1 patient in 10) are fever, and pain and erythema (redness) at the site of injection.
Slovenian: Najpogostejši neželeni učinki cepiva ProQuad (opaženi pri več kot 1 od 10 bolnikov) so povišana telesna temperatura in bolečina ter eritem (pordelost) na mestu injiciranja.
English: What is the risk associated with ProQuad?
Slovenian: Kakšna tveganja so povezana z zdravilom ProQuad?
English: The response rates in children above 12 months of age (measuring how the immune system had responded to the viruses) were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox.
Slovenian: Stopnje odziva pri otrocih, starejših od 12 mesecev (merilo odzivnosti imunskega sistema na viruse), so bile: 98 % pri ošpicah, od 96 % do 99 % pri mumpsu, 96 % pri rdečkah in 91 % pri noricah.
English: After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.
Slovenian: Po drugem odmerku so bile stopnje odziva 99 % pri ošpicah, 100 % pri mumpsu, 98 % pri rdečkah in 99 % pri noricah.
English: The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age.
Slovenian: Študija pri otrocih, starih od 9 do 12 mesecev, je pokazala, da je bil po dveh odmerkih cepiva ProQuad imunski odziv proti mumpsu, rdečkam in noricam pri otrocih, ki so prvi odmerek prejeli v 9. mesecu starosti, primerljiv s tistim pri otrocih, ki so prvi odmerek prejeli v 12. mesecu starosti.
English: For the full list of all side effects reported with ProQuad, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi cepiva ProQuad, glejte navodilo za uporabo.
English: To protect against chickenpox, a second injection is needed, given one to three months after the first one; this can be done either by giving a second dose of ProQuad, or by giving a dose of another vaccine that only protects against chickenpox.
Slovenian: Za zaščito pred noricami je potrebna druga injekcija, ki jo je treba dati od enega do tri mesece po prvem odmerku, pri čemer se lahko uporabi bodisi drugi odmerek zdravila ProQuad ali pa odmerek katerega drugega cepiva, ki ščiti samo pred noricami.
English: The Committee also recommended that the vaccine be authorised in children from nine to 12 months of age only in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Slovenian: Odbor je poleg tega priporočil, da se cepivo v določenih okoliščinah lahko uporablja tudi pri otrocih, ki so dopolnili devet do 12 mesecev, kot npr. v okviru nacionalnega programa cepljenja, ob izbruhu bolezni ali potovanju v kraje, kjer so ošpice pogost pojav.
English: For children above 12 months of age, one ProQuad injection is sufficient to provide optimal protection against measles, mumps and rubella.
Slovenian: Pri otrocih, ki so stari več kot 12 mesecev, zadostuje ena injekcija cepiva ProQuad za optimalno zaščito proti ošpicam, mumpsu in rdečkam.
English: ProQuad is available as a powder and solvent that are made up into a suspension for injection.
Slovenian: Na voljo je v obliki praška in vehikla za pripravo suspenzije za injiciranje.
English: ProQuad must not be used in children who are hypersensitive (allergic) to any chickenpox vaccine or measles, mumps or rubella vaccine, to any of the other ingredients, or to neomycin.
Slovenian: Cepivo ProQuad se ne sme uporabljati pri otrocih, ki so preobčutljivi za (alergični na) katero koli cepivo proti noricam oziroma cepivo proti ošpicam, mumpsu in rdečkam, katero koli drugo sestavino zdravila ali na neomicin.
English: The main studies were carried out to look at the ability of one or two doses of the vaccine to trigger an immune response in 5,446 healthy children (aged 12 to 23 months).
Slovenian: Glavne študije so bile izvedene pri 5 446 zdravih otrocih (starih od 12 do 23 mesecev), da bi proučili sposobnost sprožanja imunskega odziva z dajanjem enega ali dveh odmerkov cepiva.
English: ProQuad may also be given to children from nine months of age in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.
Slovenian: V določenih okoliščinah se daje tudi otrokom, ki so dopolnili devet mesecev starosti, npr. v okviru nacionalnega programa cepljenja, ob izbruhu bolezni ali pri potovanju v kraje, kjer so ošpice pogost pojav.
English: Why has ProQuad been approved?
Slovenian: Zakaj je bilo zdravilo ProQuad odobreno?
English: ProQuad is given to children from 12 months of age to help protect them against the four diseases: measles, mumps, rubella, and chickenpox.
Slovenian: Cepivo ProQuad se daje otrokom po dopolnjenem 12. mesecu starosti za zaščito pred naslednjimi štirimi boleznimi: ošpicami, mumpsom, rdečkami in noricami.
English: ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella and chickenpox.
Slovenian: Cepivo ProQuad vsebuje oslabljene oblike virusov, ki povzročajo ošpice, mumps, rdečke in norice.
English: ProQuad was compared with its ‘component vaccines', a triple vaccine against mumps, measles and rubella, and a vaccine against chickenpox.
Slovenian: Cepivo ProQuad so primerjali s „sestavljenimi cepivi“, tj. trojnim cepivom proti mumpsu, ošpicam in rdečkam, ter cepivom proti noricam.
English: How has ProQuad been studied?
Slovenian: Kako je bilo zdravilo ProQuad raziskano?
English: What is ProQuad used for?
Slovenian: Za kaj se zdravilo ProQuad uporablja?
English: How does ProQuad work?
Slovenian: Kako zdravilo ProQuad deluje?
English: How is ProQuad used?
Slovenian: Kako se zdravilo ProQuad uporablja?
English: What is ProQuad?
Slovenian: Kaj je zdravilo ProQuad?
English: ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox).
Slovenian: Zdravilo ProQuad je cepivo proti ošpicam, mumpsu, rdečkam in noricam (vodenim kozam).
English: Measles, mumps, rubella and varicella vaccine (live)
Slovenian: ProQuad cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo)
English: Children between nine and 12 months of age should receive a second dose at least three months after the first dose to ensure that they are adequately protected against measles and chickenpox.
Slovenian: Da se zagotovi ustrezna zaščita pred ošpicami in noricami, morajo otroci, stari od 9 do 12 mesecev, drugi odmerek prejeti najmanj tri mesece po prvem odmerku.
English: 3 tablets
Slovenian: 3 tablete
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU Izmišljeno Ime Jakost Farmacevtska Oblika Pot Uporabe
English: 1 tablet
Slovenian: 1 tableta
English: Package size
Slovenian: Velikost Pakiranja
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 4 pre-filled syringes l t o r
Slovenian: 4 napolnjene injekcijske brizge o ā
English: Pre-filled syringe (glass) 3 ml (1 mg/ml) 1 pre-filled syringe
Slovenian: 1 napolnjena injekcijska brizga
English: 18 weeks.
Slovenian: 18 tednov
English: Date of first authorisation: 04 December 2013 Date of latest renewal: 20 November 2018
Slovenian: Datum prve odobritve: 4. december 2013 Datum zadnjega podaljšanja: 20. november 2018
English: FFU***
Slovenian: FFE***
English: Age range as described in the protocol for the study.
Slovenian: Starostni razpon kot je opisan v protokolu za študijo.
English: Small white particles may be present.
Slovenian: Prisotni so lahko majhni beli delci.
English: This product contains genetically modified organisms (GMOs).
Slovenian: To cepivo vsebuje gensko spremenjene organizme (GSO).
English: See section 5 for advice on storage and disposal.
Slovenian: Glejte poglavje 5 za navodila o shranjevanju in odstranjevanju.
English: Each year the vaccine targets four strains of influenza, following the annual recommendations by the World Health Organisation.
Slovenian: Cepivo vsako leto cilja na štiri seve virusa gripe v skladu z vsakoletnimi priporočili Svetovne zdravstvene organizacije.
English: *** fluorescent focus units.
Slovenian: *** fluorescentna fokusna enota.
English: • allergic reactions
Slovenian: • alergijske reakcije
English: As a result, they replicate in the nasopharynx and induce protective immunity.
Slovenian: Posledično se replicirajo v nazofarinksu in inducirajo zaščitno imunost.
English: See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Slovenian: Glejte preglednici 1 in 2 za povzetek rezultatov učinkovitosti v pediatrični populaciji.
English: Some side effects may be serious
Slovenian: Nekateri neželeni učinki so lahko resni
English: For signs of allergic reactions, see section 4 “Possible side effects”.
Slovenian: Za znake alergijskih reakcij glejte poglavje 4 ”Možni neželeni učinki”.
English: Number of study participants for year 1 efficacy analysis.
Slovenian: Število preiskovancev v študiji v 1. letu analize učinkovitosti.
English: ** produced in VERO cells by reverse genetic technology.
Slovenian: ** pridobljen v celicah VERO s tehnologijo reverzne genetike.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
English: Read all of this leaflet carefully before the vaccine is given because it contains important information for you or your child.
Slovenian: Preden prejmete to cepivo, natančno preberite navodilo, ker vsebuje pomembne podatke za vas ali vašega otroka!
English: Data presented for clinical trial D153-P504 are for study participants who received two doses of study vaccine.
Slovenian: Podatki predstavljeni v klinični študiji D153-P504 so za preiskovance v študiji, ki so prejeli dva odmerka študijskega cepiva.
English: Do not inject.
Slovenian: Ne injicirajte.
English: Stability data indicate that the vaccine components are stable for 12 hours when stored at temperatures from 8°C to 25°C.
Slovenian: Podatki o stabilnosti kažejo, da so sestavine cepiva stabilne 12 ur, če je cepivo shranjeno pri temperaturi od 8 °C do 25 °C.
English: • if the child is less than 24 months of age.
Slovenian: • če je otrok star manj kot 24 mesecev.
English: • if you have a blood disorder or a cancer that affects the immune system.
Slovenian: • če imate krvno bolezen ali raka, ki vplivata na vaš imunski sistem.
English: Since 1985, two distinct lineages of influenza B viruses (Victoria and Yamagata) have circulated worldwide.
Slovenian: Od leta 1985 sta v svetu znani dve liniji virusa gripe tipa B (Victoria in Yamagata).
English: • if you have ever had a severe allergic reaction to eggs or egg proteins.
Slovenian: • če ste že kdaj imeli hudo alergijsko reakcijo na jajca oziroma jajčne beljakovine.
English: Four placebo-controlled studies included second season revaccination.
Slovenian: Štiri s placebom kontrolirane študije so vključevale drugo sezonsko revakcinacijo.
English: Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C.
Slovenian: Pred uporabo lahko cepivo enkrat vzamete iz hladilnika za največ 12 ur pri temperaturi do 25 °C.
English: • severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
Slovenian: • huda alergijska reakcija: Znaki alergijske reakcije lahko vključujejo zasoplost in oteklost obraza ali jezika.
English: Influenza Season
Slovenian: Sezona gripe
English: In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti cepiva ne smemo mešati z drugimi zdravili.
English: This is because of the risk of Reye's syndrome, a very rare but serious disease that can affect the brain and liver.
Slovenian: To je zaradi tveganja Reyevega sindroma, zelo redke, vendar resne bolezni, ki lahko prizadane možgane in jetra.
English: M=months.
Slovenian: a m = meseci b
English: • if you are allergic to gentamicin, gelatin or any of the other ingredients of this vaccine (listed in section 6 “Contents of the pack and other information”).
Slovenian: • če ste alergični na gentamicin, na želatino ali katero koli sestavino tega cepiva (navedeno v poglavju 6 ”Vsebina pakiranja in dodatne informacije”).
English: Follow your doctor, nurse or pharmacist's instructions about if and when your child should return for the second dose.
Slovenian: Upoštevajte navodila zdravnika, medicinske sestre ali farmacevta glede tega, če in kdaj naj se otrok vrne po drugi odmerek.
English: At the end of this period, Fluenz Tetra should be used immediately or discarded.
Slovenian: Ob koncu tega obdobja je treba cepivo Fluenz Tetra uporabiti takoj ali ga zavreči.
English: None of the ingredients in the vaccine can cause the flu.
Slovenian: Nobena sestavina cepiva ne more povzročiti gripe.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime zdravila in številko serije uporabljenega zdravila.
English: Not all pack sizes may be available in your country.
Slovenian: V vaši državi morda niso na voljo vsa navedena pakiranja.
English: (See also, How Fluenz Tetra is given, in section 3).
Slovenian: (Glejte tudi Kako se aplicira cepivo Fluenz Tetra, poglavje 3).
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine or other treatment.
Slovenian: • če vam je zdravnik povedal, da imate oslabljen imunski sistem kot posledico bolezni, zdravila, ki ga jemljete ali drugega načina zdravljenja.
English: * propagated in fertilised hens' eggs from healthy chicken flocks.
Slovenian: * razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat.
English: Pharmacotherapeutic group: Influenza vaccines, influenza live attenuated; ATC Code: J07BB03
Slovenian: Farmakoterapevtska skupina: cepiva proti gripi, oslabljen živ virus; oznaka ATC: J07BB03
English: If the vaccine has not been used after this 12 hour period, it should be discarded.
Slovenian: Če zdravila v teh 12 urah ne porabite, ga morate zavreči.
English: Most hospitalisations were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination.
Slovenian: Največ hospitalizacij je bilo zaradi infekcij gastrointestinalnega in respiratornega trakta, ki so se pojavile več kot 6 tednov po cepljenju.
English: You do not need to actively inhale or sniff.
Slovenian: Ni potrebno aktivno inhalirati ali vdihavati skozi nosnice.
English: Common: Pyrexia
Slovenian: Pogosti: pireksija
English: Children less than 24 months of age should not receive this vaccine because of the risk of side effects.
Slovenian: Otroci, mlajši od 24 mesecev, ne smejo prejeti tega cepiva zaradi tveganja neželenih učinkov.
English: • if you have severe asthma or are currently wheezing.
Slovenian: • če imate hudo obliko astme ali trenutno sopete.
English: Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
Slovenian: Prejemniki cepiva morajo, kjer je to mogoče, preprečiti tesen stik s hudo imunsko oslabljenimi osebami (npr. prejemniki kostnega mozga, ki po presaditvi potrebujejo izolacijo) še 1 - 2 tedna po cepljenju.
English: The vaccine may contain residues of the following substances: egg proteins (e.g. ovalbumin) and gentamicin.
Slovenian: Cepivo lahko vsebuje ostanke naslednjih snovi: jajčne beljakovine (npr. ovalbumin) in gentamicin.