FrancophonIA/ELRC3.0 huggingface dataset:
English: New onset of psoriasis (including pustular psoriasis) and worsening of pre-existing psoriasis have been reported during the use of teriflunomide.
Slovenian: Ob uporabi teriflunomida so poročali o novem pojavu psoriaze (vključno s pustulozno psoriazo) in poslabšanju že obstoječe psoriaze.
English: Uncommon: cerebrovascular accident, transient ischaemic attack, ischaemic stroke
Slovenian: Občasni: cerebrovaskularni insult, prehodni ishemični napad, ishemična možganska kap
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDSs (see section 4.8).
Slovenian: V zvezi z uporabo nesteroidnih protivnetnih zdravil (NSAID) so zelo redko3 poročali o resnih kožnih reakcijah, pri čemer so bile nekatere od njih smrtne, vključno z eksfoliativnim dermatitisom, StevensJohnsonovim sindromom in toksično epidermalno nekrolizo (glejte poglavje 4.8).
English: You should stop taking <product name> and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction.
Slovenian: Če se pri vas pojavijo kakršni koli kožni izpuščaji, lezije na sluznicah, mehurji ali drugi znaki alergije, morate zdravilo <ime zdravila> nemudoma prenehati jemati in poiskati zdravniško pomoč, saj so to lahko prvi znaki zelo resne kožne reakcije.
English: Ibrutinib - Ischaemic stroke (EPITT no 19369)
Slovenian: Ibrutinib - ishemična možganska kap (št. EPITT 19369)
English: Warnings and precautions - Take special care with <product name> Skin reactions2
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila> Opozorila in previdnostni ukrepi - Pri uporabi zdravila <ime zdravila> bodite posebej previdni: Kožne reakcije2
English: Treatment withdrawal and initiation of an accelerated elimination procedure may be considered taking into account patient's disease and medical history.
Slovenian: Ob upoštevanju bolnikove bolezni in anamneze je smiselno razmisliti o ukinitvi zdravljenja in začetku postopka pospešenega izločanja.
English: Special warnings and precautions for use Severe skin reactions
Slovenian: Posebna opozorila in previdnostni ukrepi Kožne reakcije
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products.
Slovenian: Pri zdravljenju z ibuprofenom in zdravili, ki vsebujejo psevdoefedrin, se lahko pojavijo hude kožne reakcije, npr. akutna generalizirana eksantemska pustuloza (AGEP).
English: Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
Slovenian: V povezavi z zdravili, ki vsebujejo ibuprofen, so poročali o akutni generalizirani eksantemski pustulozi (AGEP).
English: Severe skin reactions
Slovenian: Bolezni živčevja
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Slovenian: Večina teh reakcij je bila blagih do zmernih in niso bile dolgoročne.
English: The children were followed up until the end of their second year of life.
Slovenian: Otroke so spremljali do konca drugega leta življenja.
English: The children were followed up for an average of around 2 years.
Slovenian: V povprečju so otroke spremljali približno dve leti.
English: Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children.
Slovenian: V dodatnih študijah so proučevali učinke obnovitvenih cepljenj in cepljenj pri starejših dojenčkih in otrocih.
English: The vaccine is given by injection into the thigh muscle in infants or into the shoulder muscle in young children.
Slovenian: Cepivo se daje z injekcijo v stegensko mišico pri dojenčkih ali v ramensko mišico pri majhnih otrocih.
English: The full EPAR for Synflorix 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 zdravilo Synflorix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The vaccine is also adsorbed (fixed) onto an aluminium compound to stimulate a better response.
Slovenian: Cepivo je tudi „adsorbirano“ (vezano) na površino aluminijeve spojine, kar spodbudi boljši odziv.
English: This is a summary of the European public assessment report (EPAR) for Synflorix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Synflorix.
English: In Europe, it is estimated that these are responsible for 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of 5 years.
Slovenian: V Evropi se ocenjuje, da ti vplivajo na 56 do 90 % primerov invazivne bolezni, ki jih povzroča bakterija S. pneumoniae pri otrocih, mlajših od pet let.
English: The vaccination schedule for Synflorix depends on the age of the child and should be based on official recommendations.
Slovenian: Shema cepljenja za zdravilo Synflorix je odvisna od starosti otroka in mora temeljiti na uradnih priporočilih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synflorix on 30 March 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Synflorix, veljavno po vsej Evropski uniji, izdala 30. marca 2009.
English: What measures are being taken to ensure the safe and effective use of Synflorix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Synflorix?
English: For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.
Slovenian: Pri treh dodatnih polisaharidih (1, 5, 7F), je bilo zdravilo Synflorix učinkovito pri sprožanju tvorbe protiteles.
English: Synflorix contains the polysaccharides from ten different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Slovenian: Zdravilo Synflorix vsebuje polisaharide iz desetih različnih vrst bakterije S. pneumoniae (serotipe 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F in 23F).
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infection.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj brani telo pred okužbami.
English: The children received one dose of Synflorix in the first study and two doses in the second study.
Slovenian: Otroci so prejeli en odmerek zdravila Synflorix v prvi študiji in dva odmerka v drugi študiji.
English: However, children aged under 6 months with conditions that make them more likely to catch these invasive diseases, such as those with human immunodeficiency virus (HIV) infection, sickle cell disease or spleen problems, should be given three doses followed by a booster dose.
Slovenian: Vendar morajo otroci, mlajši od šest mesecev, z boleznimi, zaradi katerih so bolj dovzetni za okužbo s temi invazivnimi boleznimi, kot je na primer okužba z virusom humane imunske pomanjkljivosti (HIV), boleznijo srpastih celic ali težavami z vranico, prejeti tri odmerke, katerim sledi obnovitveni odmerek.
English: The most common side effects with Synflorix (which may affect more than 1 in 10 people) are pain, redness and swelling at the injection site, fever, drowsiness, irritability and loss of appetite.
Slovenian: Najpogostejši neželeni učinki zdravila Synflorix (ki se lahko pojavijo pri več kot 1 bolniku od 10) so bolečina, pordelost in oteklina na mestu injiciranja, vročina, zaspanost, razdražljivost in izguba teka.
English: Other information about Synflorix
Slovenian: Druge informacije o zdravilu Synflorix
English: Invasive disease results from the bacterium spreading through the body causing serious infections such as septicaemia (blood infection), meningitis (infection of the membranes around the brain and spine) and pneumonia.
Slovenian: Invazivna bolezen nastopi, ko se bakterija razširi po telesu, kar povzroči resne okužbe, kot sta septikemija (okužba krvi), meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo) in pljučnica.
English: The percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.
Slovenian: Odstotek otrok z bakterijsko pljučnico je bil 2,3 % (240 od več kot 10 000) med tistimi, ki so prejemali zdravilo Synflorix, v primerjavi s 3 % (304 od več kot 10 000) med tistimi, ki so prejemali primerjalno cepivo.
English: Synflorix is available as a suspension for injection.
Slovenian: Zdravilo Synflorix je na voljo v obliki suspenzije za injiciranje.
English: These polysaccharides have been purified, then conjugated (attached) to a carrier to help them to be recognised by the immune system.
Slovenian: Ti polisaharidi se prečistijo in nato „konjugirajo“ (vežejo) na nosilec, zaradi česar jih imunski sistem lahko prepozna.
English: The response to Synflorix in 2 to 5 year olds was similar to the younger age group, with better results in children who received two doses.
Slovenian: Odziv na zdravilo Synflorix pri skupini od dveh do pet let je bil podoben kot pri mlajši starostni skupini, pri čemer so bili boljši rezultati pri otrocih, ki so prejeli dva odmerka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synflorix have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Synflorix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: In particular, two clinical studies in children aged 2 to 5 years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups.
Slovenian: Zlasti so v dveh kliničnih študijah z otroki, starih od 2 do 5 let, proučevali zmožnost zdravila Synflorix, da tvori protitelesa v tej starostni skupini, v primerjavi z drugimi starostnimi skupinami.
English: • When Synflorix is given as part of a routine infant immunisation programme (when all infants in an area are vaccinated at around the same time), a course of two doses may be given 2 months apart, from the age of 6 weeks, followed by a booster dose at least 6 months later.
Slovenian: • Kadar se zdravilo Synflorix daje kot del rutinskega programa cepljenja dojenčkov (kadar se vsi dojenčki na območju cepijo približno isti čas), se lahko daje sklop dveh odmerkov v razmaku dveh mesecev, od starosti šest tednov dalje, temu pa sledi obnovitveni odmerek najmanj šest mesecev pozneje.
English: For more information about treatment with Synflorix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Synflorix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between 6 and 12 weeks.
Slovenian: Učinkovitost cepiva Synflorix pri sprožanju nastanka protiteles (imunogenosti) so ocenjevali v eni glavni študiji, v kateri je sodelovalo 1 650 zdravih dojenčkov, starih od šest do 12 tednov.
English: It is used to protect infants and children aged between 6 weeks and 5 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Slovenian: Uporablja se za zaščito dojenčkov in otrok, starih od šest tednov do pet let, pred invazivno boleznijo, pljučnico (okužbo pljuč) in akutnim vnetjem srednjega ušesa, ki ga povzroča bakterija S. pneumoniae.
English: In studies in infants and older children, although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled pre-defined criteria and was considered acceptable in this group.
Slovenian: V študijah z dojenčki in starejšimi otroki so bila, čeprav je bil pri zdravilu Synflorix manjši odziv na protitelesa kot pri primerjalnem cepivu, izpolnjena vnaprej določena merila, zato je zdravilo veljalo za sprejemljivo v tej skupini.
English: The Agency also noted that Synflorix contains additional polysaccharides from the types of S. pneumoniae that are responsible for disease in Europe and therefore decided that Synflorix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Ugotovila je tudi, da vsebuje zdravilo Synflorix dodatne polisaharide iz vrst bakterije S. pneumoniae, ki povzročajo bolezen v Evropi, zato je sklenila, da so koristi zdravila Synflorix večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Synflorix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Synflorix was effective in protecting against invasive disease: no cases were seen among the 10,000 children given three doses of Synflorix and a booster dose, one case occurred among the 10,000 children given two doses of Synflorix and a booster dose and 12 cases occurred in 10,000 children given the comparator vaccine.
Slovenian: Zdravilo Synflorix je bilo učinkovito pri zaščiti pred invazivno boleznijo: med 10 000 otroki, ki so prejeli tri odmerke zdravila Synflorix in obnovitveni odmerek, ni bilo primerov; en primer se je pojavil pri 10 000 otrocih, ki so prejeli dva odmerka zdravila Synflorix in obnovitveni odmerek; in 12 primerov se je pojavilo pri 10 000 otrocih, ki so prejeli primerjalno cepivo.
English: Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F).
Slovenian: Zdravilo Synflorix je bilo enako učinkovito kot primerjalno cepivo pri sprožanju tvorbe protiteles proti petim polisaharidom (4, 9V, 14, 18C in 19F), ki so skupni obema cepivoma, vendar je bilo pri dveh (6B in 23F) manj učinkovito od primerjalnega cepiva.
English: The studies showed that Synflorix led to an increase in antibody production following booster vaccinations.
Slovenian: Tri študije so pokazale, da je zdravilo Synflorix povzročilo povečano tvorb protiteles po obnovitvenih cepljenjih.
English: What benefits of Synflorix have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Synflorix izkazalo v študijah?
English: A fourth (‘booster') dose is recommended at least 6 months after the third dose, preferably when the child is between 12 and 15 months of age.
Slovenian: Četrti (obnovitveni) odmerek se priporoča najmanj šest mesecev po tretjem odmerku, po možnosti pri starosti otroka med 12 in 15 mesecev.
English: What is Synflorix and what is it used for?
Slovenian: Kaj je zdravilo Synflorix in za kaj se uporablja?
English: Synflorix was also investigated in a large study involving around 24,000 children aged between 6 and 16 weeks that focussed mainly on the vaccine's benefit in preventing community acquired pneumonia.
Slovenian: Zdravilo Synflorix so proučevali tudi v večji študiji s približno 24 000 otroki, starih od šest do 16 tednov, katere cilj je bil predvsem ugotoviti koristi cepiva pri preprečevanju zunajbolnišnične pljučnice.
English: The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the investigational vaccine compared with those given the comparator.
Slovenian: Pojavitev prve epizode akutnega vnetja srednjega ušesa, ki ga povzroča bakterija S. pneumoniae, je bila približno dvakrat manjša pri otrocih, ki so prejeli cepivo v preskušanju, v primerjavi z otroki, ki so prejeli primerjalno cepivo.
English: What are the risks associated with Synflorix?
Slovenian: Kakšna tveganja so povezana z zdravilom Synflorix?
English: It is recommended that a booster dose is given at least 2 months after the second dose, during the child's second year of life.
Slovenian: Priporočljivo je, da se obnovitveni odmerek injicira najmanj dva meseca po drugem odmerku v drugem letu otrokovega življenja.
English: Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Slovenian: Zdravilo Synflorix vsebuje majhne količine polisaharidov (vrste sladkorja), pridobljenih iz „ovojnice“, ki obdaja bakterijo S. pneumoniae.
English: The study involved almost 5,000 infants aged 3 months and compared an investigational vaccine that contains the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae (in this case, a vaccine against hepatitis A virus).
Slovenian: Študija je vključevala skoraj 5 000 dojenčkov, starih tri mesece, in v njej so cepivo v preskušanju, ki vsebuje enake polisaharide kot zdravilo Synflorix, primerjali z drugim cepivom, ki ni aktivno proti bakteriji S. pneumoniae (v tem primeru cepivo proti virusu hepatitisa A).
English: Why is Synflorix approved?
Slovenian: Zakaj je bilo zdravilo Synflorix odobreno?
English: The children in this study were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae and were followed up for an average of 30 months.
Slovenian: Otroci v tej študiji so prejemali zdravilo Synflorix ali primerjalno cepivo, ki ni bilo aktivno proti bakteriji S. pneumoniae; spremljali so jih v povprečju 30 mesecev.
English: The European Medicines Agency noted that the immune system's response to Synflorix was comparable to its response to another vaccine, which is also authorised for the protection of children against S. pneumoniae in the EU.
Slovenian: Evropska agencija za zdravila je ugotovila, da je bil imunski odziv na zdravilo Synflorix primerljiv z imunskim odzivom na drugo cepivo, ki je prav tako odobreno v EU za zaščito otrok pred okužbo z bakterijo S. pneumoniae.
English: Synflorix is a vaccine that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae, also called pneumococcus).
Slovenian: Zdravilo Synflorix je cepivo, ki vsebuje dele bakterije Streptococcus pneumoniae (S. pneumoniae, imenovane tudi pnevmokoki).
English: The study compared the immunogenicity of Synflorix with that of another vaccine that is authorised in the EU to protect children against S. pneumoniae infection, and which contains seven of the ten polysaccharides in Synflorix.
Slovenian: V študiji so primerjali imunogenost zdravila Synflorix in drugega cepiva, ki je odobreno v EU za zaščito otrok pred okužbo z bakterijo S. pneumoniae in vsebuje sedem od desetih polisaharidov iz zdravila Synflorix.
English: It is recommended that a booster dose be given at least 6 months after the third dose.
Slovenian: Priporočljivo je, da se obnovitveni odmerek injicira najmanj šest mesecev po tretjem odmerku.
English: Based on a comparison of the immune response of Synflorix with the investigational vaccine used in the study, Synflorix is expected to provide similar protection against acute otitis media caused by S. pneumoniae.
Slovenian: Na podlagi primerjave imunskega odziva zdravila Synflorix s cepivom v preskušanju, ki se je uporabljalo v študiji, je pričakovati, da zdravilo Synflorix zagotavlja podobno zaščito pred akutnim vnetjem srednjega ušesa, ki ga povzroča bakterija S. pneumoniae.
English: Synflorix is a vaccine that protects against infections caused by S. pneumoniae.
Slovenian: Zdravilo Synflorix je cepivo, ki ščiti pred okužbami z bakterijo S. pneumoniae.
English: Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae.
Slovenian: Zdravilo Synflorix so ocenjevali v večji študiji z več kot 30 000 dojenčki, mlajšimi od sedem mesecev, ki so prejemali zdravilo Synflorix ali primerjalno cepivo, ki ni bilo aktivno proti bakteriji S. pneumoniae.
English: The immune system will then be able to produce antibodies more quickly when it comes into contact with the bacterium again.
Slovenian: Ob ponovni izpostavitvi bakteriji bo imunski sistem tako lahko hitreje tvoril protitelesa.
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Slovenian: Synflorix cepivo proti pnevmokokom, polisaharidno, konjugirano (adsorbirano)
English: For the full list of side effects with Synflorix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Synflorix, glejte navodilo za uporabo.
English: Synflorix must not be used in children who have a high fever, but it can be given in children who have a mild infection such as a cold. For the full list of restrictions, see the package leaflet.
Slovenian: Zdravilo Synflorix se ne sme uporabljati pri otrocih, ki imajo povišano telesno temperaturo, lahko pa ga jemljejo otroci, ki imajo blago okužbo, na primer prehlad.
English: Another main study looked at whether Synflorix prevents acute otitis media.
Slovenian: V drugi glavni študiji so proučevali, ali zdravilo Synflorix preprečuje akutno vnetje srednjega ušesa.
English: It is not intended to provide practical advice on how to use Synflorix.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How does Synflorix work?
Slovenian: Kako zdravilo Synflorix deluje?
English: • Premature babies (born between 27 and 36 weeks gestation) are given a course of three doses with an interval of at least one month between each dose, with the first dose given at 2 months of age.
Slovenian: • Nedonošenčki (rojeni med 27. in 36. tednom nosečnosti) prejmejo sklop treh odmerkov v razmaku najmanj enega meseca med posameznimi odmerki, pri čemer se prvi odmerek injicira pri starosti dveh mesecev.
English: • Infants aged between 6 weeks and 6 months are given a course of three doses with an interval of at least one month between each dose, with the first dose usually given at 2 months of age.
Slovenian: • Dojenčki, stari od šest tednov do šest mesecev, prejmejo sklop treh odmerkov v razmaku najmanj enega meseca med posameznima odmerkoma, pri čemer se prvi odmerek običajno injicira pri starosti dveh mesecev.
English: How is Synflorix used?
Slovenian: Kako se zdravilo Synflorix uporablja?
English: • Children aged between 12 months and 5 years are given a course of two doses with an interval of at least 2 months between them.
Slovenian: • Otroci, stari od 12 mesecev do pet let, prejmejo sklop dveh odmerkov v razmaku najmanj dveh mesecev.
English: • Infants aged between 7 and 11 months are given a course of two doses with an interval of at least one month between them.
Slovenian: • Dojenčki, stari od sedem do enajst mesecev, prejmejo sklop dveh odmerkov v razmaku najmanj enega meseca.
English: However, these effects have only been observed during early treatment.
Slovenian: Vendar so bili ti učinki opaženi le pri zgodnjem zdravljenju.
English: This linear extrapolation is questionable, since the processes involved are not linear.
Slovenian: Ta linearna ekstrapolacija je vprašljiva, saj vključeni procesi niso linearni.
English: Determination of specific conditions
Slovenian: Določitev specifičnih pogojev
English: requested a re-examination of the CVMP opinion.
Slovenian: zahtevalo ponovno preučitev mnenja odbora CVMP.
English: However, more studies are required to fill remaining data gaps in this area and to confirm these effects.
Slovenian: Vendar bo potrebnih še več študij, ki bodo zapolnile vrzeli v podatkih s tega področja in potrdile te učinke.
English: Reduction of global use of antibiotics
Slovenian: Zmanjšanje vsesplošne uporabe antibiotikov
English: The administration period was 14 or 21 days immediately after weaning.
Slovenian: Obdobje dajanja je bilo 14 ali 21 dni takoj po odstavitvi.