FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the level of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Slovenian: Glavno merilo učinkovitosti je bila raven protiteles proti virusu gripe v krvi v različnih obdobjih: pred cepljenjem, na dan druge injekcije (21. dan) in 21 dni pozneje (42. dan).
English: This is expected to help to protect against the disease caused by the virus.
Slovenian: To naj bi pripomoglo k zaščiti pred boleznijo, ki jo povzroča virus.
English: The injections were given 21 days apart.
Slovenian: Injekcije so bile dane v razmiku 21 dni.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium), which is expected to stimulate a better response.
Slovenian: Cepivo vsebuje tudi „adjuvans“ (sestavino, ki vsebuje aluminij), ki naj bi spodbudil boljši odziv.
English: Therefore, the Committee was also concerned that the vaccine's immunogenicity was low, regardless of the strain of virus included, and that the vaccine might not be able to adequately prepare the immune system for future infections.
Slovenian: Odbor je zato izrazil tudi pomislek, da je imunogenost cepiva nizka ne glede na vključeni sev virusa in da cepivo morda ne bo sposobno ustrezno pripraviti imunski sistem na prihodnje okužbe.
English: Emerflu contains a flu strain called ‘A/Vietnam/1194/2004 NIBRG 14' (H5N1).
Slovenian: Zdravilo Emerflu vsebuje sev gripe, imenovan „A/Vietnam/1194/2004 NIBRG 14“ (H5N1).
English: They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Slovenian: Nato lahko preskusijo cepivo, da ugotovijo, kako se ljudje odzivajo nanj, na podlagi česar lahko napovejo, kako se bodo ljudje odzvali, ko bo vključen sev gripe, ki povzroča pandemijo.
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Slovenian: V skladu z merili, ki jih je določil CHMP, mora modelno cepivo spodbuditi zaščitne ravni protiteles pri najmanj 70 % oseb, da se šteje za primernega.
English: The higher dose vaccine also contained the adjuvant.
Slovenian: Cepivo z višjim odmerkom je vsebovalo tudi adjuvans.
English: The effects of Emerflu were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Emerflu so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Slovenian: Pred začetkom pandemije nihče ne ve, kateri sev virusa gripe bo vključen, zato farmacevtske družbe ne morejo vnaprej pripraviti pravega cepiva.
English: It was only intended for use once a flu pandemic had been officially declared.
Slovenian: Uporabljalo naj bi se samo, ko bi bila pandemija gripe uradno razglašena.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „naučijo“ obrambe pred boleznijo.
English: Emerflu is a vaccine.
Slovenian: Zdravilo Emerflu je cepivo.
English: It is a suspension for injection that contains parts of influenza (flu) viruses that have been inactivated (killed).
Slovenian: Je suspenzija za injiciranje, ki vsebuje delce virusov gripe (influence), ki so inaktivirani (uničeni).
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Slovenian: Lahko pa pripravijo cepivo, ki vsebuje posebej izbran sev virusa gripe, ki mu ni bil nihče izpostavljen in proti kateremu ni nihče imun.
English: Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.
Slovenian: Ker je bila v glavnih študijah tvorba protiteles po dajanju zdravila Emerflu pod to ravnjo (manj kot 40 % pri udeležencih, mlajših od 60 let), je CHMP izrazil pomisleke, da zdravilo Emerflu ni primerno za uporabo kot modelno cepivo.
English: On 1 December 2010, Sanofi Pasteur SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Emerflu, for the prevention of ‘pandemic' flu.
Slovenian: Družba Sanofi Pasteur SA je dne 1. decembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Emerflu, namenjenim preprečevanju pandemske gripe.
English: Withdrawal of the marketing authorisation application for Emerflu [pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)]
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Emerflu [cepivo proti pandemski gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)]
English: Emerflu contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Slovenian: Zdravilo Emerflu vsebuje majhne količine hemaglutininov (beljakovin s površine) virusa, imenovanega H5N1.
English: In addition, 100 further people received Emerflu that contained a different strain of flu virus.
Slovenian: Poleg tega je drugih 100 oseb prejelo zdravilo Emerflu, ki je vsebovalo drugačen sev virusa gripe.
English: Similar results were seen in the people who received Emerflu that contained a different strain of flu virus, and there were contradictory results in the studies looking at the effects of a third dose of Emerflu.
Slovenian: Podobni rezultati so bili opaženi pri osebah, ki so prejele zdravilo Emerflu, ki je vsebovalo drugačen sev virusa gripe, v študijah, v katerih so proučevali učinke tretjega odmerka zdravila Emerflu, pa so si rezultati nasprotovali.
English: The CHMP was concerned over the ability of Emerflu to trigger the production of enough antibodies against the flu virus.
Slovenian: CHMP je imel pomisleke glede sposobnosti zdravila Emerflu za sprožitev tvorbe zadostne količine protiteles proti virusu gripe.
English: The main study of Emerflu included 600 healthy adults and compared the ability of two doses of Emerflu, to trigger the production of antibodies (‘immunogenicity').
Slovenian: V glavni študiji zdravila Emerflu, ki je vključevala 600 zdravih odraslih, so primerjali sposobnost dveh odmerkov zdravila Emerflu za sprožitev tvorbe protiteles („imunogenost“).
English: Emerflu was expected to be used in adults to protect against ‘pandemic' flu.
Slovenian: Zdravilo Emerflu naj bi se uporabljalo pri odraslih za zaščito pred pandemsko gripo.
English: The company informed the CHMP that, at the time of the withdrawal, there were no clinical trials being carried out with Emerflu.
Slovenian: Družba je obvestila CHMP, da v času umika vloge ni bilo nobenih kliničnih preskušanj zdravila Emerflu.
English: At that point in time, the CHMP was of the opinion that the benefits of Emerflu used for prophylaxis of influenza in an officially declared pandemic situation did not outweigh its risks.
Slovenian: Takrat je CHMP menil, da koristi zdravila Emerflu, ki se uporablja za preprečevanje gripe v primeru uradne razglasitve pandemije, ne odtehtajo z njim povezanih tveganj.
English: If a pandemic were to start, the virus strain in Emerflu would have been replaced by the strain causing the pandemic before the vaccine could have been used.
Slovenian: Če bi prišlo do pandemije, bi sev virusa v zdravilu Emerflu nadomestili s sevom, ki povzroča pandemijo, in cepivo bi bilo mogoče uporabljati šele po tem.
English: Some of the participants in the studies of Emerflu went on to receive a third dose of the vaccine, containing either of the two flu virus strains, with or without the adjuvant.
Slovenian: Nekateri udeleženci študij zdravila Emerflu so nato prejeli še tretji odmerek cepiva z enim od dveh sevov virusa gripe, z adjuvansom ali brez njega.
English: What was Emerflu expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Emerflu uporabljalo?
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Slovenian: Po cepljenju imunski sistem prepozna virus kot „tujek“, zato proti njemu začne tvoriti protitelesa.
English: The participants received two injections of Emerflu containing one of two different doses of haemagglutinin.
Slovenian: Sodelujoči so prejeli dve injekciji zdravila Emerflu z enim od dveh različnih odmerkov hemaglutinina.
English: What is Emerflu?
Slovenian: Kaj je zdravilo Emerflu?
English: Hence, the CHMP recommended that Emerflu be refused marketing authorisation.
Slovenian: CHMP je zato priporočil zavrnitev dovoljenja za promet z zdravilom Emerflu.
English: A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Slovenian: Do pandemije gripe pride, ko se pojavi nova vrsta (sev) virusa gripe, ki se hitro širi med ljudmi, ker proti njemu ljudje niso imuni (zaščiteni).
English: Emerflu was expected to work as a ‘mock-up' vaccine.
Slovenian: Zdravilo Emerflu naj bi delovalo kot modelno cepivo.
English: How was Emerflu expected to work?
Slovenian: Kako naj bi zdravilo Emerflu delovalo?
English: The immune system is then able to produce antibodies more quickly when it is exposed to the virus again.
Slovenian: Ob ponovni izpostavitvi virusu je imunski sistem sposoben hitreje tvoriti protitelesa.
English: Further information on Grasustek can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/grasustek.
Slovenian: Nadaljnje informacije o zdravilu Grasustek so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/grasustek.
English: What measures are being taken to ensure the safe and effective use of Grasustek?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Grasustek?
English: This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: An overview of Grasustek and why it is authorised in the EU
Slovenian: Pregled zdravila Grasustek in zakaj je odobreno v EU
English: The most common side effect with Grasustek (which may affect more than 1 in 10 people) is pain in the bones.
Slovenian: Najpogostejši neželeni učinek zdravila Grasustek (ki se lahko pojavi pri več kot 1 bolniku od 10) je bolečina v kosteh.
English: Why is Grasustek authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Grasustek odobreno v EU?
English: What is Grasustek and what is it used for?
Slovenian: Kaj je zdravilo Grasustek in za kaj se uporablja?
English: Grasustek is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of cancer treatment.
Slovenian: Zdravilo Grasustek se daje v obliki enkratnega 6-miligramskega odmerka, ki se injicira pod kožo vsaj 24 ur po koncu vsakega ciklusa zdravljenja raka.
English: What benefits of Grasustek have been shown in studies?
Slovenian: Kakšne koristi zdravila Grasustek so se pokazale v študijah?
English: What are the risks associated with Grasustek?
Slovenian: Kakšna tveganja so povezana z zdravilom Grasustek ?
English: Other information about Grasustek
Slovenian: Druge informacije o zdravilu Grasustek
English: Severe neutropenia lasted just over one-and-a-half days on average with both medicines.
Slovenian: Pri obeh zdravilih je huda oblika nevtropenije v povprečju trajala malo več kot en dan in pol.
English: As for all medicines, data on the use of Grasustek are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Grasustek stalno spremljajo.
English: Side effects reported with Grasustek are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Grasustek, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The reference medicine for Grasustek is Neulasta.
Slovenian: Referenčno zdravilo za zdravilo Grasustek je zdravilo Neulasta.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Grasustek have 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 Grasustek upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Grasustek can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Slovenian: Predpisovanje in izdaja zdravila Grasustek je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem rakavih obolenj ali krvnih bolezni.
English: For more information about using Grasustek, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Grasustek glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: All these data were considered sufficient to conclude that Grasustek will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Grasustek pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
English: The active substance in Grasustek, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Slovenian: Učinkovina zdravila Grasustek, pegfilgrastim, je vrsta filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
English: The safety of Grasustek has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Slovenian: Varnost zdravila Grasustek je bila ocenjena in na podlagi vseh izvedenih študij so bili neželeni učinki zdravila ocenjeni kot primerljivi z neželenimi učinki referenčnega zdravila Neulasta.
English: Because Grasustek is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Grasustek.
Slovenian: Zdravilo Grasustek je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Grasustek ni treba ponavljati.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Grasustek has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Grasustek po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neulasta in da se po telesu enako prenaša.
English: In addition, a study involving 248 patients who had chemotherapy after surgery for breast cancer showed that Grasustek was as effective as Neulasta in reducing the duration of neutropenia.
Slovenian: Poleg tega so v študiji, ki je vključevala 248 bolnic, ki so se po kirurškem posegu zaradi raka na dojki zdravile s kemoterapijo, dokazali, da je zdravilo Grasustek pri skrajševanju trajanja nevtropenije enako učinkovito kot zdravilo Neulasta.
English: For the full list of side effects and restrictions with Grasustek, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Grasustek glejte navodilo za uporabo.
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Grasustek in reducing the duration of neutropenia is equivalent to that of Neulasta.
Slovenian: Poleg tega so študije pri bolnicah z rakom na dojki, ki so prejemale kemoterapijo, pokazale, da je učinkovitost zdravila Grasustek pri zmanjševanju trajanja nevtropenije, enakovredna zdravilu Neulasta.
English: Grasustek is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Slovenian: Zdravilo Grasustek ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
English: Therefore, the Agency's view was that, as for Neulasta, the benefits of Grasustek outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je agencija menila, da koristi zdravila Grasustek enako kot pri zdravilu Neulasta odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: In Grasustek, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: V zdravilu Grasustek je filgrastim „pegiliran“ (vezan na kemično snov, imenovano polietilenglikol).
English: Grasustek is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections.
Slovenian: Grasustek je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nevtropeniji (zmanjšanem številu nevtrofilcev, vrste belih krvnih celic), ki je pogost neželeni učinek pri zdravljenju raka s kemoterapijo, zaradi katerega pa so bolniki dovzetnejši za okužbe.
English: Studies have also shown that giving Grasustek produces similar levels of the active substance in the body to giving Neulasta.
Slovenian: Študije so pokazale tudi, da zdravilo Grasustek vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
English: Grasustek is a ‘biosimilar medicine'.
Slovenian: Zdravilo Grasustek je „podobno biološko zdravilo“.
English: How is Grasustek used?
Slovenian: Kako se zdravilo Grasustek uporablja?
English: Laboratory studies comparing Grasustek with Neulasta have shown that the active substance in Grasustek is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Grasustek primerjali z zdravilom Neulasta, so pokazale, da je učinkovina zdravila Grasustek po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
English: How does Grasustek work?
Slovenian: Kako zdravilo Grasustek deluje?
English: This summary was last updated in 06-2006.
Slovenian: Ta povzetek je bil nazadnje posodobljen 06-2006.
English: The marketing authorisation was renewed on 4 July 2004.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 4. julija 2004.
English: Medicinal product no longer authorise©EMEA 2006
Slovenian: Zdravilo nima veā dovoljenja za prome©EMEA 2006
English: The doses and duration of treatment depend on to the patient's response to the medicine.
Slovenian: Odmerki in trajanje zdravljenja so odvisni od odziva bolnika na zdravilo.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Forcaltonin to Unigene UK Limited on 11 January 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Forcaltonin, veljavno po vsej Evropski uniji, odobrila družbi Unigene UK Limited dne 11. januarja 1999.
English: This included the results of three studies of the effectiveness and safety of Forcaltonin in 94 women, including 58 with osteoporosis.
Slovenian: To je obsegalo rezultate treh raziskav učinkovitosti in varnosti zdravila Forcaltonin pri 94 ženskah, od katerih jih je 58 imelo osteoporozo.
English: Other information about Forcaltonin:
Slovenian: Druge informacije o zdravilu Forcaltonin:
English: These studies measured the markers of bone metabolism.
Slovenian: V teh raziskavah so merili označevalce presnove kosti.
English: The most common side effect found in about 10% of patients is nausea (feeling sick) with or without vomiting.
Slovenian: Najpogostejši neželeni učinek, opažen pri približno 10 % bolnikov, je bila slabost z ali brez bruhanja.
English: This side effect is less common when the injection is given in the evening and after meals.
Slovenian: Ta neželeni učinek je redkejši, če se zdravilo injicira zvečer ali po obroku.
English: Salmon calcitonin, either extracted from salmon or synthetic (man-made), has been in use as a medicine since the mid-1970s.
Slovenian: Lososov kalcitonin, ki se pridobi iz lososa ali izdela sintetično, uporabljamo kot zdravilo že od sredine 1970-ih.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FORCALTONIN EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FORCALTONIN Povzetek EPAR za javnost
English: Other common side effects are skin flushes (face or upper body).
Slovenian: Drugi pogosti neželeni učinek je rdečica na koži (obraza ali zgornjega dela telesa).
English: The active substance of Forcaltonin, salmon calcitonin, is a copy of the hormone produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce salmon calcitonin.
Slovenian: Zdravilna učinkovina zdravila Forcaltonin, lososov kalcitonin, je kopija hormona, ki se izdeluje z metodo, imenovano „tehnologija rekombinantne DNA“: izdela ga celica, ki je prejela gen (DNA), s katerim lahko tvori lososov kalcitonin.
English: The doctor may decide to perform a skin test to check the patient's allergy status before prescribing the medicine.
Slovenian: Pred izdajo recepta za zdravilo se lahko zdravnik odloči za izvedbo kožnega preskusa, s katerim preveri alergijski status bolnika.
English: In severe or emergency cases, Forcaltonin may be given as an intravenous infusion (10 IU per kg body weightover 6 hours).
Slovenian: V hudih ali nujnih primerih lahko zdravilo Forcaltonin dajemo kot intravensko infuzijo (10 i.e. na kg telesne mase v trajanju 6 ur).
English: This side effect is more likely at the start of treatment and tends to decrease or disappear with further doses or smaller doses.
Slovenian: Ta neželeni učinek je pogostejši na začetku zdravljenja, z nadaljevanjem zdravljenja ali zmanjšanjem odmerka pa se običajno zmanjša ali izzveni.
English: Each ampoule contains 100 IU (International Units) of the active substance salmon calcitonin.
Slovenian: Vsaka ampula vsebuje 100 i.e. (mednarodnih enot) zdravilne učinkovine lososovega kalcitonina.
English: In hypercalcaemia, the recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection.
Slovenian: Pri hiperkalciemiji je priporočeni začetni odmerek 100 i.e. vsakih 6 do 8 ur s podkožno ali intramuskularno injekcijo.
English: Forcaltonin can only be obtained with a prescription.
Slovenian: Zdravilo Forcaltonin se dobi samo na recept.
English: Forcaltonin contains the active ingredient salmon calcitonin, which works in the same way as natural human calcitonin but it is more effective and longer lasting.
Slovenian: Zdravilna učinkovina v zdravilu Forcaltonin je lososov kalcitonin, ki deluje kot naravni človeški kalcitonin, vendar je učinkovitejši in deluje dlje.
English: What benefit has Forcaltonin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Forcaltonin izkazalo med raziskavami?