FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended vaccination schedule consists of three doses within the first six months of life, with at least four weeks between each dose.
Slovenian: Priporočena shema cepljenja je sestavljena iz treh odmerkov, ki se jih daje v prvih šestih mesecih življenja s časovnimi presledki najmanj 4 tedne.
English: A booster dose is recommended before the end of the second year of life.
Slovenian: Priporočljivo je obnovitveno cepljenje pred zaključkom drugega leta življenja.
English: This means that the toxoids and the parts of the hepatitis B virus are fixed onto aluminium compounds, to stimulate a better immune response.
Slovenian: To pomeni, da sta toksoida in deli virusa hepatitisa B fiksirani na aluminijeve spojine za boljšo stimulacijo imunskega odziva.
English: The most common side effects with Tritanrix HepB (seen in more than 1 in 10 doses of the vaccine) are drowsiness, feeding problems, fever, redness, swelling, pain, unusual crying and irritability.
Slovenian: Najpogostejši neželeni učinki cepiva Tritanrix HepB (opaženi pri več kot 1 izmed 10 odmerkov cepiva) so zaspanost, težave pri hranjenju, zvišana telesna temperatura, pordelost, otekanje, bolečine, neobičajen jok in razdražljivost.
English: Tritanrix HepB has been studied in six studies involving a total of 872 infants aged between seven and 20 weeks, all of whom received the vaccine.
Slovenian: Cepivo Tritanrix HepB je bilo preučeno v šestih študijah, v katere je bilo vključenih skupno 872 dojenčkov, starih od 7 do 20 tednov.
English: The main measure of effectiveness was the production of protective antibodies in the infants after the first set of vaccinations.
Slovenian: Glavno merilo učinkovitosti je bila raven zaščitnih protiteles v krvi dojenčkov po opravljenem prvem cepljenju.
English: The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Tritanrix HepB on 19 July 1996.
Slovenian: Evropska Komisija je dovoljenje za promet s cepivom Tritanrix HepB, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 19. julija 1996.
English: Further studies looked at the effects of the vaccine in younger infants and at the persistence of antibody levels after vaccination.
Slovenian: V dodatnih študijah so preučevali učinke cepiva na mlajše dojenčke in vztrajanje ravni protiteles po
English: The effects of Tritanrix HepB were first tested in experimental modes before being studied in humans.
Slovenian: Učinki cepiva Tritanrix HepB so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: If a vaccine against hepatitis B has not been given at birth, Tritanrix HepB can be given as early as eight weeks of age.
Slovenian: Če cepivo proti hepatitisu B ni bilo dano ob rojstvu, se lahko cepivo Tritanrix HepB prične dajati pri osmih tednih starosti.
English: Their breathing should be monitored for up to three
Slovenian: Pri teh otrocih je treba dihanje spremljati
English: • killed whole B. pertussis, the bacterium that causes pertussis;
Slovenian: • uničene cele bakterije B. pertussis, ki povzroča oslovski kašelj,
English: Tritanrix HepB is a vaccine, which is available as a suspension for injection.
Slovenian: Zdravilo Tritanrix HepB je cepivo, ki je na voljo kot suspenzija za injiciranje.
English: Tritanrix HepB should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Slovenian: Cepivo Tritanrix HepB se ne sme uporabljati za dojenčke, ki utegnejo biti preobčutljivi za (alergični na) zdravilne učinkovine ali katerokoli drugo sestavino zdravila.
English: Other information about Tritanrix HepB:
Slovenian: Druge informacije o zdravilu Tritanrix HepB:
English: The studies showed that the production of protective levels of antibodies against diphtheria, tetanus and hepatitis B occurred in at least 98% of the infants.
Slovenian: Študije so pokazale, da je imelo najmanj 98 % dojenčkov zaščitne ravni protiteles proti davici, tetanusu in hepatitisu B. Najmanj 92 % dojenčkov je imelo zaščitne ravni protiteles proti oslovskemu
English: Tritanrix HepB is a vaccine.
Slovenian: Zdravilo Tritanrix HepB je cepivo.
English: It contains toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough) and parts of the hepatitis B virus as active substances.
Slovenian: Cepivo vsebuje naslednje zdravilne učinkovine: toksoida (kemijsko oslabljena toksina) iz bakterij, ki povzročata davico in tetanus, inaktivirano (uničeno) bakterijo Bordetella pertussis (bakterijo, ki povzroča oslovski
English: What benefit has Tritanrix HepB shown during the studies?
Slovenian: Kakšne koristi je zdravilo Tritanrix HepB izkazalo med študijami?
English: In areas where hepatitis B is common, vaccination against hepatitis B at birth should be continued as normal, with Tritanrix HepB started at six weeks of age.
Slovenian: V področjih, kjer je hepatitis B pogost, je treba po cepljenju proti hepatitisu B ob rojstvu nadaljevati s cepivom Tritanrix HepB pri šestih
English: As for all vaccines, if Tritanrix HepB is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Slovenian: Če cepivo Tritanrix HepB kot tudi vsa cepiva uporabimo pri veliko prezgodaj rojenih nedonošenčkih, obstaja tveganje pojava apneje (kratkih prekinitev dihanja).
English: For the full list of all side effects reported with Tritanrix HepB, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Tritanrix HepB, glejte navodilo za uporabo.
English: Tritanrix HepB is given by deep injection into a muscle, preferably the thigh.
Slovenian: Cepivo Tritanrix HepB se daje z globokim injiciranjem v mišico, najboljše v stegno.
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses contained in the vaccine as ‘foreign' and makes antibodies against them.
Slovenian: • „površinski antigen“ (beljakovino površine) virusa hepatitisa B. Ko otroka cepimo, imunski sistem prepozna dele bakterij in virusa v cepivu kot „tuje“ in izdela protitelesa, usmerjena proti njim.
English: What is the risk associated with Tritanrix HepB?
Slovenian: Kakšna tveganja so povezana z zdravilom Tritanrix HepB?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TRITANRIX HEPB EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TRITANRIX HEPB
English: It should also not be used in infants who have had an allergic reaction after being given diphtheria, tetanus, pertussis or hepatitis B vaccines.
Slovenian: Cepivo se ne sme uporabljati tudi za dojenčke, ki so imeli alergično reakcijo po cepljenju proti davici, tetanusu, oslovskemu kašlju ali hepatitisu B. Cepljenje s cepivom Tritanrix HepB je treba odložiti pri dojenčkih s hudo, nenadno zvišano telesno temperaturo.
English: Tritanrix HepB should be postponed in infants with a severe sudden fever, and it should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination
Slovenian: Cepiva ne smejo prejeti otroci, ki so imeli encefalopatijo (bolezen možganov) neznanega vzroka v sedmih dneh po prejšnjem cepljenju s cepivom proti oslovskemu
English: Tritanrix HepB contains small amounts of:
Slovenian: Cepivo Tritanrix HepB vsebuje majhne
English: The Committee recommended that Tritanrix HepB be
Slovenian: Odbor je priporočil, da se za cepivo Tritanrix HepB odobri
English: How has Tritanrix HepB been studied?
Slovenian: Kako je bilo zdravilo Tritanrix HepB raziskano?
English: Tritanrix HepB is used to vaccinate infants from six weeks of age against diphtheria, tetanus, pertussis The medicine can only be obtained with a prescription.
Slovenian: Cepivo Tritanrix HepB se uporablja za cepljenje otrok, mlajših od šest tednov, proti davici, tetanusu,
English: The full EPAR for Tritanrix HepB can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tritanrix HepB je na voljo
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Tritanrix HepB's benefits are greater than its risks for active immunisation against diphtheria, tetanus, pertussis and hepatitis B in infants from six weeks onwards.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Tritanrix HepB večje od z njim povezanih tveganj.
English: Response to treatment was defined as reduction by at least 50% in the signs of melanoma.
Slovenian: Odziv na zdravljenje je bil opredeljen kot vsaj 50-odstotno zmanjšanje znakov melanoma.
English: The full EPAR and risk management plan summary for Imlygic 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) in povzetek načrta obvladovanja tveganj za zdravilo Imlygic sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Imlygic?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imlygic?
English: The second dose is given three weeks after the first dose and treatment is continued every two weeks for at least six months, unless the doctor considers that the patient is not benefiting from the medicine.
Slovenian: Drugi odmerek se da tri tedne po prvem odmerku, zdravljenje pa se nadaljuje na dva tedna vsaj šest mesecev, razen če zdravnik oceni, da bolniku zdravilo ne koristi.
English: Imlygic talimogene laherparepvec
Slovenian: Imlygic talimogen laherparepvek
English: Other information about Imlygic
Slovenian: Druge informacije o zdravilu Imlygic
English: This is a summary of the European public assessment report (EPAR) for Imlygic.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imlygic.
English: This is a type of medicine that works by delivering genes into the cells of the body.
Slovenian: Gre za skupino zdravil, ki delujejo tako, da prenesejo gene v celice v telesu.
English: The company has put in place a controlled distribution programme to qualified centres to ensure that the cold storage and handling requirements are observed and to control the distribution to the patients.
Slovenian: Družba je vzpostavila program nadzorovanega izdajanja v kvalificirane centre, s čimer se zagotavlja upoštevanje zahtev za hladno shranjevanje in ravnanje ter nadzoruje izdajanje bolnikom.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and for whom the response lasted for at least six months before the patients' health declined or they required another therapy.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so se odzvali na zdravljenje in pri katerih je odziv trajal vsaj šest mesecev, preden se je bolnikovo zdravstveno stanje poslabšalo ali je potreboval drugo vrsto zdravljenja.
English: Treatment with Imlygic should be started and given under the supervision of a doctor with expertise in the treatment of cancer.
Slovenian: Zdravljenje z zdravilom Imlygic se sme uvesti in izvajati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem raka.
English: A risk management plan has been developed to ensure that Imlygic is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Imlygic je bil pripravljen načrt obvladovanja tveganj.
English: Although Imlygic can enter healthy cells, it is not designed to multiply inside them.
Slovenian: Čeprav lahko zdravilo Imlygic vstopa tudi v zdrave celice, ni zasnovano tako, da bi se v njih razmnoževalo.
English: Most of these side effects were mild or moderate in severity.
Slovenian: Večina teh neželenih učinkov je bila blaga ali zmerna.
English: This protein stimulates the patient's immune system (the body's natural defences) to recognise and destroy melanoma cells.
Slovenian: Ta beljakovina spodbuja bolnikov imunski sistem (naravno obrambo telesa), da prepozna in uniči celice melanoma.
English: When looking at the subset of patients in the study (249 patients) whose disease had not spread to the lung or other internal organs, 25% (41 out of 163) of patients treated with Imlygic had a sustained response to treatment, compared with around 1% (1 out of 86) of patients treated with GM-CSF.
Slovenian: V podskupini bolnikov v študiji (249 bolnikov), pri katerih se bolezen ni razširila na pljuča ali druge notranje organe, je do trajnega odziva na zdravljenje prišlo pri 25 % (41 od 163) bolnikov, zdravljenih z zdravilom Imlygic, in pri približno 1 % (1 od 86) bolnikov, zdravljenih z GM-CSF.
English: Thus, CHMP decided that Imlygic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor je zato zaključil, da so koristi zdravila Imlygic večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Imlygic is available as a solution for injection in two different strengths.
Slovenian: Zdravilo Imlygic je na voljo v obliki raztopine za injiciranje v dveh različnih jakostih.
English: The most common serious side effect (affecting around 2 in 100 people) was cellulitis (infection of the upper layers of the skin).
Slovenian: Najpogostejši resni neželeni učinek (ki je prizadel približno 2 osebi od 100) je bil celulitis (okužba zgornjih plasti kože).
English: What benefits of Imlygic have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Imlygic izkazalo v študijah?
English: What is Imlygic and what is it used for?
Slovenian: Kaj je zdravilo Imlygic in za kaj se uporablja?
English: The volume to be injected depends on the size of the tumour and the number of tumours to be injected.
Slovenian: Injicirana količina je odvisna od velikosti in števila tumorjev.
English: The company will also carry out three studies to further characterise the benefits and risks of Imlygic, including a study of Imlygic in patients with advanced melanoma that can be surgically removed.
Slovenian: Družba bo izvedla tudi tri študije, s katerimi bodo nadalje opredelili koristi in tveganja zdravila Imlygic, vključno s študijo zdravila Imlygic pri bolnikih z napredovalim melanomom, ki se lahko kirurško odstrani.
English: As part of this programme, the medicine will only be supplied to doctors who have received appropriate educational materials on the risk of herpes infection, particularly in patients with an impaired immune system, on the risk of transmission of the virus to healthcare professionals or other close contacts of the patient (accidental exposure), and on the necessary precautions to be taken when administering and disposing of the product.
Slovenian: Kot del tega programa bo to zdravilo izdano samo zdravnikom, ki so prejeli ustrezno izobraževalno gradivo o tveganjih za herpesno okužbo, zlasti pri bolnikih z oslabljenim imunskim sistemom, o tveganju za prenos virusa na zdravstvene delavce ali druge osebe, ki prihajajo v tesen stik z bolnikom (naključna izpostavljenost), in o potrebnih previdnostnih ukrepih pri dajanju in odstranjevanju zdravila.
English: It is derived from a weakened herpes simplex virus 1 (the cold sore virus).
Slovenian: Pridobljen je iz oslabljenega virusa herpes simpleks tipa 1 (virus herpes na ustnicah).
English: It is not intended to provide practical advice on how to use Imlygic.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In addition, Imlygic makes the infected melanoma cells produce a protein called GM-CSF.
Slovenian: Poleg tega zdravilo Imlygic v okuženih celicah melanoma sproži proizvodnjo beljakovine, imenovane GM-CSF.
English: Because Imlygic contains a herpes virus, it may reactivate at a later time causing herpes infections such as cold sores.
Slovenian: Ker zdravilo Imlygic vsebuje virus herpes, se lahko pozneje ponovno aktivira in povzroči herpesne okužbe, kot je herpes na ustnici.
English: In patients whose immune system is weak (e.g. patients with HIV), Imlygic may cause more widespread disease.
Slovenian: Pri bolnikih z oslabljenim imunskim sistemom (npr. bolnikih z virusom HIV) lahko zdravilo Imlygic povzroči bolj razširjeno bolezen.
English: Patients will also be provided with educational materials and a patient alert card informing on the risks with the medicine and how to avoid accidental exposure to Imlygic.
Slovenian: Tudi bolniki bodo prejeli izobraževalno gradivo in opozorilno kartico, ki bo vsebovala informacije o tveganjih, povezanih z zdravilom, in kako se izogniti naključni izpostavljenosti zdravilu Imlygic.
English: What are the risks associated with Imlygic?
Slovenian: Kakšna tveganja so povezana z zdravilom Imlygic?
English: It is given as an injection into melanoma tumours.
Slovenian: Daje se z injekcijo v melanomske tumorje.
English: The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea (feeling sick), flu-like illness and pain at the injection site.
Slovenian: Najpogostejši neželeni učinki zdravila Imlygic (ki lahko prizadenejo več kot 1 osebo od 4) so utrujenost, mrzlica, pireksija (zvišana telesna temperatura), navzeja (slabost), gripi podobna bolezen in bolečina na mestu injiciranja.
English: Imlygic must not be used in patients with a severely impaired immune system because if the virus gets reactivated, the herpes infection could spread to other parts of the body.
Slovenian: Zdravilo Imlygic se ne sme uporabljati pri bolnikih z močno oslabljenim imunskim sistemom, ker se herpesna okužba v primeru ponovne aktivacije virusa lahko razširi na druge dele telesa.
English: Why is Imlygic approved?
Slovenian: Zakaj je bilo zdravilo Imlygic odobreno?
English: It contains the active substance talimogene laherparepvec.
Slovenian: Vsebuje zdravilno učinkovino talimogen laherparepvek.
English: Regarding safety, Imlygic was relatively well tolerated and most side effects were mild or moderate in severity.
Slovenian: Kar zadeva varnost, so bolniki zdravilo Imlygic sorazmerno dobro prenašali, večina neželenih učinkov je bila namreč blaga ali zmerna.
English: This virus has been modified so it can infect and multiply inside melanoma cells.
Slovenian: Ta virus je spremenjen tako, da lahko okuži celice melanoma in se v njih razmnožuje.
English: For the full list of all side effects and restrictions reported with Imlygic, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Imlygic, glejte navodilo za uporabo.
English: For more information about treatment with Imlygic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Imlygic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Imlygic, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Imlygic naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The active substance in Imlygic, talimogene laherparepvec, is a type of gene therapy called ‘oncolytic virus'.
Slovenian: Zdravilna učinkovina zdravila Imlygic, talimogen laherparepvek, je vrsta zdravila za gensko zdravljenje, imenovana „onkolitični virus“.
English: The study, which lasted 24 months, compared Imlygic with GM-CSF injected under the skin.
Slovenian: V študiji, ki je trajala 24 mesecev, so zdravilo Imlygic primerjali s podkožno injiciranim GMCSF.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imlygic, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Imlygic in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Imlygic is a therapy with a novel mechanism of action which can be a valuable addition to existing therapies for advanced inoperable melanoma, an area of unmet medical need.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je opozoril, da ima zdravilo Imlygic nov mehanizem delovanja, ki je lahko dragocen dodatek obstoječim načinom zdravljenja za napredovali melanom, ki ga ni mogoče kirurško odstraniti, tj. na področju, kjer medicinske potrebe ostajajo neizpolnjene.
English: The first dose is given using the lower strength of Imlygic, but subsequent doses use the higher strength.
Slovenian: Pri prvem odmerku se uporabi manjša jakost zdravila Imlygic, pri vseh naslednjih pa večja.
English: Imlygic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that cannot be surgically removed and that has spread to other parts of the body (but not to bone, lung, brain and other internal organs).
Slovenian: Imlygic je zdravilo za zdravljenje raka, ki se uporablja pri odraslih z melanomom (vrsto kožnega raka), ki ga ni mogoče kirurško odstraniti in se je že razširil na druge dele telesa (vendar ne na kosti, pljuča, možgane in druge notranje organe).
English: Imlygic has been studied in one main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (but not to bone and brain).
Slovenian: Zdravilo Imlygic so proučevali v glavni študiji, v katero je bilo vključenih 436 bolnikov z melanomom, ki ga ni mogoče kirurško odstraniti in se je razširil na druge dele telesa (vendar ne na kosti ali možgane).
English: Patients with inoperable melanoma which had spread to other parts of the body (but not to bone, brain or lung) showed a prolonged reduction in their melanoma tumours when treated with Imlygic, although it is still not known whether this will translate into longer survival.
Slovenian: Z zdravljenjem z zdravilom Imlygic so pri bolnikih z melanomom, ki ga ni mogoče kirurško odstraniti in se je razširil na druge dele telesa (vendar ne na kosti, možgane ali pljuča), dokazali dolgotrajno zmanjšanje melanomskih tumorjev, vendar še ni jasno, ali to pomeni tudi daljše preživetje.
English: Imlygic is a type of advanced therapy medicine called a ‘gene therapy product'.
Slovenian: Zdravilo Imlygic spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila za gensko zdravljenje“.
English: How is Imlygic used?
Slovenian: Kako se zdravilo Imlygic uporablja?
English: Imlygic uses the melanoma cells' own machinery to multiply, eventually overwhelming melanoma cells and killing them.
Slovenian: Zdravilo Imlygic za razmnoževanje uporablja mehanizem celic melanoma ter jih s tem sčasoma preobremeni in uniči.
English: How does Imlygic work?
Slovenian: Kako zdravilo Imlygic deluje?
English: This information is presented below.
Slovenian: Ti podatki so predstavljeni spodaj.
English: 06 May 2019
Slovenian: 6. maja 2019
English: The clinical relevance of this finding is uncertain.
Slovenian: Klinični pomen teh ugotovitev je negotov.
English: If this happens to you, do not drive or use any tools or machines.
Slovenian: Če se to pojavi pri vas, ne vozite ali uporabljajte orodja ali strojev.
English: Ελλάδα Teva Ελλάς Α.Ε.
Slovenian: Teva Ελλάς Α.Ε.
English: Patients 75 years and older
Slovenian: Bolniki, stari 75 let in več
English: Gemcitabine (N=430)
Slovenian: Gemcitabin (N = 430)
English: • Depression, sleep problems
Slovenian: • depresija, težave s spanjem
English: The reconstituted dispersion should be milky and homogenous without visible precipitates.
Slovenian: Rekonstituirana disperzija mora biti mlečna in homogena brez vidnih oborin.
English: Cycles were administered at 3 week intervals.
Slovenian: Cikluse so prejemali v razmikih 3 tednov.
English: • if you have heart problems.
Slovenian: • če imate težave s srcem.