FrancophonIA/ELRC3.0 huggingface dataset:
English: The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexyon.
Slovenian: Učinke so primerjali s kombinacijo ločenih cepiv, namenjenih za zaščito pred boleznimi, ki so vključene v cepivo Hexyon.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hexyon have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo cepiva, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Hexyon contains small amounts of materials derived from the bacteria and viruses it protects against.
Slovenian: Zdravilo Hexyon vsebuje majhne količine materiala, pridobljenega iz bakterij in virusov, proti katerim ščiti.
English: Regarding safety, the CHMP considered that Hexyon's overall safety profile is similar to other vaccines, although vaccination with Hexyon is more likely than similar vaccines to cause reactions (mainly at the injection site).
Slovenian: Kar zadeva varnost, je CHMP mnenja, da je celotni varnostni profil cepiva Hexyon podoben drugim cepivom, čeprav je bolj verjetno, da bo cepivo Hexyon povzročilo reakcije (večinoma na mestu injiciranja), kot druga cepiva.
English: It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy, unless the condition has stabilised with treatment and the benefit clearly outweighs the risk.
Slovenian: Ne sme se uporabljati pri otrocih, ki imajo nenadzorovana ali resna obolenja možganov ali živčnega sistema, kot je nenadzorovana epilepsija (napadi), razen če se je stanje z zdravljenjem ustalilo in so koristi cepljenja veliko večje od tveganj.
English: What are the risks associated with Hexyon?
Slovenian: Kakšna tveganja so povezana z zdravilom Hexyon?
English: What benefits of Hexyon have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Hexyon izkazalo v študijah?
English: Why is Hexyon approved?
Slovenian: Zakaj je bilo zdravilo Hexyon odobreno?
English: For more information about treatment with Hexyon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Hexyon preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Hexyon and what is it used for?
Slovenian: Kaj je zdravilo Hexyon in za kaj se uporablja?
English: Hexyon has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules.
Slovenian: Cepivo Hexyon je bilo proučevano v različnih državah sveta v 12 glavnih študijah, ki so vključevale več kot 3 400 otrok, starih od šest tednov do dveh let, in ki so v skladu z različnimi lokalnimi shemami cepljenja prejeli tri odmerke cepiva v prvih šestih mesecih življenja.
English: It is not intended to provide practical advice on how to use Hexyon.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Hexyon must not be used in children who have ever had an allergic reaction to Hexyon or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Slovenian: Cepiva Hexyon se ne sme uporabljati pri otrocih, ki so v preteklosti imeli alergijsko reakcijo nanj ali cepivo, ki vsebuje enake sestavine, vključno s snovmi, ki se uporabljajo med procesom izdelave cepiva in ki so lahko prisotne v zelo majhnih količinah (kot sta antibiotika neomicin ali streptomicin).
English: The most common side effects with Hexyon include pain and redness at the site of injection, irritability and crying.
Slovenian: Najpogostejši neželeni učinki cepiva Hexyon vključujejo bolečino in rdečico na mestu injiciranja, razdražljivost in jok.
English: For practical information about using Hexyon, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Hexyon naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Vaccination with Hexyon should be postponed if a child has a moderate to severe fever.
Slovenian: Cepljenje s cepivom Hexyon je treba odložiti, če ima otrok srednje ali zelo povišano telesno temperaturo.
English: Hexyon or an appropriate combination of other vaccines can be used for the booster dose.
Slovenian: Za poživitveni odmerek se lahko uporabi cepivo Hexyon ali ustrezna kombinacija drugih cepiv.
English: Hexyon is available as a suspension for injection in vials and prefilled syringes.
Slovenian: Cepivo Hexyon je na voljo kot suspenzija za injiciranje v vialah in napolnjenih injekcijskih brizgah.
English: For the full list of all side effects reported with Hexyon, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Hexyon, glejte navodilo za uporabo.
English: The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexyon; protection was maintained or improved when a booster dose was given.
Slovenian: Študije so pokazale, da so se zaščitne ravni protiteles, ki ščitijo pred različnimi boleznimi, razvile pri 90 do 100 % otrok po prvih treh odmerkih cepiva Hexyon.
English: These studies showed that Hexyon produces similar antibody profiles over time to comparable vaccines, and that the vaccine can be given at the same time as Prevenar and Rotarix.
Slovenian: Te študije so pokazale, da so po določenem času profili protiteles, ustvarjeni s cepivom Hexyon, podobni tistim, ki jih ustvarijo primerjalna cepiva, in da se sme cepivo uporabljati sočasno s cepivoma Prevenar in Roatrix.
English: Hexyon is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
Slovenian: Cepivo Hexyon se daje običajno z injekcijo globoko v stegensko ali ramensko mišico.
English: It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Slovenian: Cepivo Hexyon se ne sme uporabljati pri otrocih, ki so v preteklosti preboleli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po prejemu cepiva, ki je vsebovalo komponente oslovskega kašlja.
English: How does Hexyon work?
Slovenian: Kako zdravilo Hexyon deluje?
English: Hexyon is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
Slovenian: Zdravilo Hexyon je cepivo, ki vsebuje zdravilne učinkovine, pridobljene iz bakterij davice, tetanusa, oslovskega kašlja in Haemophilus influenzae tipa b, virusa hepatitisa B in neaktiviranih poliovirusov.
English: The CHMP noted that Hexyon has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b infections in children between six weeks and two years of age regardless of ethnicity.
Slovenian: Ugotovil je, da je bilo dokazano, da cepivo Hexyon ustvari zaščitne ravni protiteles proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, otroški paralizi in okužbam, ki jih povzročajo bakterije H. influenzae tipa b pri otrocih, starih od šest mesecev do dveh let, ne glede na njihovo etnično pripadnost.
English: How is Hexyon used?
Slovenian: Kako se zdravilo Hexyon uporablja?
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Slovenian: Hexyon konjugirano (adsorbirano) cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rDNK), otroški paralizi (inaktivirano) in bakteriji Haemophilus influenzae tipa b
English: A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexyon, and another study in 1,336 children evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix).
Slovenian: V drugi študiji so pri 1 336 otrocih proučevali odziv na različne skupine cepiv in kaj se zgodi, če se cepivo daje sočasno s cepivi za okužbe, ki jih povzročata bakterija Streptococcus pneumoniae (Prevenar) in rotavirus (Rotarix).
English: In the study, children who either received Hexyon produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.
Slovenian: Študija je pokazala, da so se pri otrocih, ki so prejeli cepivo Hexyon v dveh odmerkih, ki mu je čez šest mesecev sledil obnovitveni odmerek, ustvarile primerljive ravni protiteles, kot pri tistih, ki so prejeli primerjalno cepivo (Infanrix hexa).
English: Treatment is continued for as long as the disease is not getting worse.
Slovenian: Zdravljenje se nadaljuje, dokler se bolezen ne poslabša.
English: Further information on Lynparza can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lynparza.
Slovenian: Nadaljnje informacije za zdravilo Lynparza so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/lynparza.
English: What measures are being taken to ensure the safe and effective use of Lynparza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lynparza?
English: Furthermore, while tablets can be taken with food or between meals, the patient should take the capsules at least 1 hour after food and not eat for up to 2 hours afterwards.
Slovenian: Tablete se lahko jemljejo s hrano ali med obroki, kapsule pa mora bolnik vzeti vsaj eno uro po obroku in nato ne sme jesti še vsaj dve uri.
English: The European Medicines Agency therefore decided that Lynparza's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Lynparza večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Lynparza received a marketing authorisation valid throughout the EU on 16 December 2014.
Slovenian: Za zdravilo Lynparza je bilo 16. decembra 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: The side effects with Lynparza were mostly mild or moderate and were generally manageable.
Slovenian: Neželeni učinki zdravila Lynparza so bili v glavnem blagi ali zmerni in so bili na splošno obvladljivi.
English: The most common side effects with Lynparza (which may affect more than 1 in 10 people) are tiredness, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (heartburn), cough, headache, dysgeusia (taste disturbances), decreased appetite, dizziness, upper abdominal pain (stomach ache), dyspnoea (difficulty breathing), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and thrombocytopenia (low blood platelet counts).
Slovenian: Najpogostejši neželeni učinki zdravila Lynparza (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so utrujenost, navzeja (siljenje na bruhanje), bruhanje, driska, dispepsija (zgaga), kašelj, glavobol, disgevzija (motnja okušanja), zmanjšan tek, omotica, bolečine v zgornjem delu trebuha, dispneja (oteženo dihanje), anemija (nizka raven rdečih krvnih celic), levkopenija (nizka raven belih krvnih celic), nevtropenija (nizka raven nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam) in trombocitopenija (nizko število trombocitov).
English: Women must not breastfeed during treatment with Lynparza and for a month after stopping treatment.
Slovenian: Ženske med zdravljenjem z zdravilom Lynparza in še en mesec po koncu zdravljenja ne smejo dojiti.
English: As for all medicines, data on the use of Lynparza are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lynparza stalno spremljajo.
English: Other information about Lynparza
Slovenian: Druge informacije o zdravilu Lynparza
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynparza have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lynparza upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: In advanced ovarian cancer, the doctor may stop treatment after 2 years if X-rays show no signs of the cancer.
Slovenian: Pri napredovalem raku jajčnikov lahko zdravnik po dveh letih preneha zdravljenje, če rentgenski posnetki ne kažejo znakov raka.
English: Lynparza is a cancer medicine used on its own for:
Slovenian: Lynparza je zdravilo za zdravljenje raka, ki se uporablja kot samostojno zdravilo za:
English: Lynparza is available as tablets (100 and 150 mg) and capsules (50 mg) which the patient takes twice a day.
Slovenian: Zdravilo Lynparza je na voljo v obliki tablet (100 in 150 mg) in kapsul (50 mg), ki jih bolnik jemlje dvakrat na dan. Odmerki v miligramih se pri tabletah in kapsulah razlikujejo.
English: The dose and the choice between capsules and tablets of Lynparza depends on what disease it is being used for.
Slovenian: Odmerek in izbira tablet ali kapsul zdravila Lynparza sta odvisna od bolezni, za katero se zdravilo uporablja.
English: Lynparza can increase the time these patients live without their disease getting worse.
Slovenian: Zdravilo Lynparza lahko podaljša čas preživetja teh bolnikov brez poslabšanja bolezni.
English: What benefits of Lynparza have been shown in studies?
Slovenian: Kakšne koristi zdravila Lynparza so se pokazale v študijah?
English: Side effects reported with Lynparza are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Lynparza, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Lynparza, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Lynparza glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: An overview of Lynparza and why it is authorised in the EU
Slovenian: Pregled zdravila Lynparza in zakaj je odobreno v EU
English: Why is Lynparza authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Lynparza odobreno v EU?
English: The company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit, of the medicine in patients with ovarian cancer.
Slovenian: Podjetje, ki trži zdravilo Lynparza, bo izvedlo študije za nadaljnjo potrditev koristi, vključno z dolgoročno koristjo zdravila pri raku jajčnikov.
English: Lynparza can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Lynparza je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: Therefore, when PARP proteins are blocked, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.
Slovenian: Z zaviranjem beljakovin PARP se poškodovana DNK v rakavih celicah ne more popraviti, zato rakave celice odmrejo.
English: The active substance in Lynparza, olaparib, blocks the action of enzymes called human poly (ADP ribose) polymerase (PARP), which help to repair damaged DNA in cells (both in normal and in cancer cells) during cell division.
Slovenian: Učinkovina v zdravilu Lynparza, olaparib, zavira delovanje encimov, imenovanih humane poli (ADPriboza) polimeraze (PARP), ki v celicah (normalnih in rakavih) pomagajo popravljati poškodovano DNK.
English: Lynparza contains the active substance olaparib.
Slovenian: Zdravilo Lynparza vsebuje učinkovino olaparib.
English: What are the risks associated with Lynparza?
Slovenian: Kakšna tveganja so povezana z zdravilom Lynparza?
English: • treatment of breast cancer which is HER2-negative and that has spread beyond the original site in patients with mutations in BRCA1 or BRCA2 genes who have been treated with certain breast cancer medicines (unless these medicines were not suitable).
Slovenian: • zdravljenje raka dojk, ki je HER2-negativen in se je razširil zunaj prvotne lokacije pri bolnikih z mutacijami v genih BRCA1 ali BRCA2 , ki so bili zdravljeni z določenimi zdravili za zdravljenje raka (razen če ta zdravila niso bila primerna).
English: What is Lynparza and what is it used for?
Slovenian: Kaj je zdravilo Lynparza in za kaj se uporablja?
English: Lynparza was effective in a study involving 302 patients with HER2-negative breast cancer with BRCA1/2 mutations whose cancer had spread.
Slovenian: Zdravilo Lynparza je bilo učinkovito v študiji, ki je vključevala 302 bolnika s HER2-negativnim rakom dojke z mutacijami genov BRCA1/2, pri katerih se je rak razširil.
English: • In a third study involving 391 patients with advanced cancer who had BRCA1/2 mutations, the disease had not got worse in around 74% of patients who took Lynparza for 2 years compared with 35% of patients on placebo.
Slovenian: • V tretji študiji, v katero je bilo vključenih 391 bolnikov z napredovalim rakom z mutacijami genov BRCA1/2, se bolezen ni poslabšala pri približno 74 % bolnikov, ki so jemali zdravilo Lynparza dve leti, v primerjavi z 35 % bolnikov, ki so prejemali placebo.
English: Studies show that Lynparza increases the time patients live without their disease getting worse after treatment with platinum-based chemotherapy has reduced or cleared the cancer:
Slovenian: Študije so pokazale, da zdravilo Lynparza podaljša čas, ki ga bolniki preživijo brez poslabšanja bolezni po zmanjšanju ali odstranitvi raka s kemoterapijo na osnovi platine.
English: − in newly diagnosed women with advanced cancer with mutations (changes) in one or both genes known as BRCA1 and BRCA2 who have been treated with platinum-based chemotherapy and in whom this treatment has reduced or cleared the cancer;
Slovenian: − ženskah z novo diagnosticiranim napredovalim rakom z mutacijami (spremembami) v enem ali obeh genih, znanih kot BRCA1 in BRCA2, ki so bile zdravljene s kemoterapijo na osnovi platine, zaradi česar se je rak zmanjšal ali izginil;
English: For the full list of side effects and restrictions with Lynparza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Lynparza glejte navodilo za uporabo.
English: • continuing treatment of high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in:
Slovenian: • nadaljevalno zdravljenje raka visoke stopnje (hitrorastočega raka) jajčnikov, jajcevodov (ki povezujejo jajčnike z maternico) in potrebušnice (mrene v trebušni votlini) pri:
English: In ovarian, fallopian tube or peritoneal cancers, Lynparza can also delay the next cycle of platinum chemotherapy.
Slovenian: Pri raku jajčnikov, jajcevodov ali potrebušnice lahko zdravilo Lynparza odloži naslednji cikel kemoterapije na osnovi platine.
English: − women whose cancer had come back (relapsed) after previous treatment and in whom platinum-based chemotherapy has reduced or cleared the cancer;
Slovenian: − ženskah, katerih rak se je po predhodnem zdravljenju ponovno pojavil in pri katerih se je s kemoterapijo na osnovi platine zmanjšal ali izginil;
English: Patients treated with Lynparza lived on average 7.0 months without their disease getting worse compared with 4.2 months for patients treated with the doctor's choice of another cancer medicine.
Slovenian: Bolniki, zdravljeni z zdravilom Lynparza, so v povprečju živeli 7,0 meseca brez poslabšanja bolezni, bolniki, zdravljeni z drugim zdravilom za zdravljenje raka po zdravnikovi presoji, pa štiri mesece.
English: How does Lynparza work?
Slovenian: Kako zdravilo Lynparza deluje?
English: Generally the outcome is poor for patients with ovarian, fallopian tube or peritoneal cancers and for patients with HER2-negative breast cancer with BRCA mutations whose cancer has spread.
Slovenian: Na splošno je izid pri bolnikih z rakom jajčnikov, jajcevodov ali potrebušnice ter pri bolnikih s HER2negativnim rakom dojke z mutacijami gena BRCA, pri katerih se je rak razširil, slab.
English: • In another study involving 265 patients with relapsed cancer, those who took Lynparza lived on average for 8.4 months without their disease getting worse compared with 4.8 months for patients on placebo.
Slovenian: • V drugi študiji, v katero je bilo vključenih 265 bolnikov s ponovljenim rakom, so tisti, ki so jemali zdravilo Lynparza, brez poslabšanja bolezni povprečno živeli 8,4 meseca, bolniki, ki so jemali placebo, pa 4,8 meseca.
English: How is Lynparza used?
Slovenian: Kako se zdravilo Lynparza uporablja?
English: • A study of 295 patients with relapsed cancer of the ovary, fallopian tube or peritoneum found that those receiving Lynparza lived on average for 19.1 months without their disease getting worse compared with 5.5 months for patients receiving placebo (a dummy treatment).
Slovenian: • V študiji z 295 bolniki s ponovljenim rakom jajčnikov, jajcevodov ali potrebušnice so ugotovili, da so bolniki, ki so prejemali zdravilo Lynparza, brez poslabšanja bolezni povprečno živeli 19,1 meseca, bolniki, ki so prejemali placebo (zdravilo brez učinkovine), pa 5,5 meseca.
English: Treatment may be interrupted or stopped or the dose reduced if certain side effects develop.
Slovenian: Če se pojavijo določeni neželeni učinki, bo morda treba začasno ali trajno prekiniti zdravljenje ali zmanjšati odmerek.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat on 29 August 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Vimpat, veljavno po vsej Evropski uniji, izdala 29. avgusta 2008.
English: It can also be used in patients who are temporarily unable to take the tablets or syrup.
Slovenian: Prav tako se lahko uporablja pri bolnikih, ki začasno ne morejo jemati tablet ali sirupa.
English: What measures are being taken to ensure the safe and effective use of Vimpat?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vimpat?
English: The full EPAR for Vimpat 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 Vimpat je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Vimpat and what is it used for?
Slovenian: Kaj je zdravilo Vimpat in za kaj se uporablja?
English: Vimpat infusion can be used to begin treatment.
Slovenian: Infuzija zdravila Vimpat se lahko uporablja za začetek zdravljenja.
English: It explains how the Agency assessed the medicine to recommend its authorisation and its conditions of use.
Slovenian: Pojasnjuje, kako je agencija ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev in pogoje njegove uporabe.
English: It is not intended to provide practical advice on how to use Vimpat.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Vimpat have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Vimpat izkazalo v študijah?