FrancophonIA/ELRC3.0 huggingface dataset:
English: One of the vaccines was Optaflu, a previously authorised vaccine which contains three of the four strains of influenza in Flucelvax Tetra and whose effectiveness in preventing flu is well established.
Slovenian: Eno izmed teh cepiv je bilo zdravilo Optaflu, ki je bilo predhodno odobreno cepivo in vsebuje tri od štirih sevov gripe, ki se nahajajo v zdravilu Flucelvax Tetra in katerih učinkovitost je bila že dokazana.
English: Flucelvax Tetra is as effective as the comparator vaccines at stimulating immune responses against the 4 strains included in the vaccine in people from 9 years of age.
Slovenian: Zdravilo Flucelvax Tetra je enako učinkovito kot primerjalna cepiva pri spodbujanju imunskega odziva proti 4 sevom, vključenim v cepivo pri osebah, starejših od devet let.
English: Flucelvax Tetra is a vaccine.
Slovenian: Zdravilo Flucelvax Tetra je cepivo.
English: For the full list of side effects and restrictions with Flucelvax Tetra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Flucelvax Tetra glejte navodilo za uporabo.
English: What is Flucelvax Tetra and what is it used for?
Slovenian: Kaj je zdravilo Flucelvax Tetra in za kaj se uporablja?
English: What benefits of Flucelvax Tetra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Flucelvax Tetra izkazalo v študijah?
English: The viruses used to produce Flucelvax Tetra are grown in mammalian cells.
Slovenian: Virusi, ki se uporabljajo v cepivu , so vzgojeni v celicah sesalcev.
English: What are the risks associated with Flucelvax Tetra?
Slovenian: Kakšna tveganja so povezana z zdravilom Flucelvax Tetra?
English: Historically, seasonal flu vaccines have contained three strains of flu: one influenza A-H1N1 virus, one influenza AH3N2 virus, and one influenza B virus.
Slovenian: V preteklosti so cepiva proti gripi vsebovala tri seve virusa gripe: en virus gripe A-H1N1, en virus gripe AH3N2 in en virus gripe B. Zdravilo Flucelvax Tetra vsebuje dodaten sev virusa gripe B.
English: Flucelvax Tetra contains proteins from the surface of four different strains of flu virus.
Slovenian: Zdravilo Flucelvax Tetra vsebuje delce s površine štirih različnih sevov virusa gripe.
English: Together the comparator vaccines contain the four strains of influenza in Flucelvax Tetra.
Slovenian: Primerjalni cepivi skupaj vsebujeta vse štiri seve, ki se nahajajo v zdravilu Flucelvax Tetra.
English: How is Flucelvax Tetra used?
Slovenian: Kako se zdravilo Flucelvax Tetra uporablja?
English: How does Flucelvax Tetra work?
Slovenian: Kako zdravilo Flucelvax Tetra deluje?
English: Flucelvax Tetra includes an additional B virus strain.
Slovenian: Flucelvax Tetra (cepivo proti gripi [površinski antigen,
English: What measures are being taken to ensure the safe and effective use of Liprolog?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Liprolog?
English: Liprolog Mix is a mixture of these two formulations.
Slovenian: Liprolog Mix je mešanica teh dveh pripravkov.
English: The full EPAR for Liprolog 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 Liprolog je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Liprolog on 1 August 2001.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Liprolog, veljavno po vsej Evropski uniji, izdala dne 1. avgusta 2001.
English: Patients can inject themselves with this medicine if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo Liprolog vbrizgajo sami, če so bili za to ustrezno usposobljeni.
English: This is a summary of the European public assessment report (EPAR) for Liprolog.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Liprolog.
English: • Liprolog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Slovenian: • Liprolog: raztopina insulina lispro, na voljo v standardni ali višji jakosti (100 ali 200 enot/ml);
English: For more information about treatment with Liprolog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Liprolog preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Liprolog
Slovenian: Druge informacije o zdravilu Liprolog
English: Liprolog and Liprolog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary.
Slovenian: Zdravili Liprolog in Liprolog Mix se običajno dajeta tik pred obrokom, po potrebi pa se lahko jemljeta tudi kmalu po obroku.
English: Studies also looked at the use of Liprolog in 542 patients aged between two and 19 years, and the use of Liprolog in combination with sulphonylureas.
Slovenian: V študijah so proučevali tudi uporabo zdravila Liprolog pri 542 bolnikih, starih od dve do 19 let, in uporabo zdravila Liprolog v kombinaciji s sulfonilsečninami.
English: What is the risk associated with Liprolog?
Slovenian: Kakšna tveganja so povezana z zdravilom Liprolog?
English: Insulin lispro is very slightly different from human insulin.
Slovenian: Insulin lispro se zelo malo razlikuje od humanega insulina.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Liprolog.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What benefit has Liprolog shown during the studies?
Slovenian: Kakšne koristi je zdravilo Liprolog izkazalo med študijami?
English: In addition, the company that makes Liprolog has provided information to patients and healthcare professionals to remind them that there are two strengths of Liprolog and to advise them on how to use them safely to avoid medication errors.
Slovenian: Poleg tega je družba, ki izdeluje zdravilo Liprolog, bolnikom in zdravstvenim delavcem zagotovila informacije, ki jih opominjajo, da obstajata dve jakosti zdravila Liprolog in nasvete o tem, kako ju varno uporabljati v izogib napačni uporabi.
English: The difference means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster.
Slovenian: Razlika je v tem, da človeško telo insulin lispro absorbira hitreje kot običajni humani insulin, zaradi česar lahko hitreje učinkuje.
English: A risk management plan has been developed to ensure that Liprolog is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Liprolog je bil pripravljen načrt obvladovanja tveganj.
English: Liprolog is a range of solutions and suspensions for injection.
Slovenian: Zdravilo Liprolog je serija raztopin in suspenzij za injiciranje.
English: LiprologLiprolog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Slovenian: Odmerke zdravila Liprolog bo morda treba prilagoditi, če se jemlje sočasno z nekaterimi drugimi zdravili, ki bi lahko vplivala na raven glukoze v krvi.
English: Liprolog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Slovenian: Zdravilo Liprolog so najprej proučevali v okviru osmih kliničnih študij z 2 951 bolniki s sladkorno boleznijo tipa 1 (pri kateri trebušna slinavka ne more tvoriti insulina) ali sladkorno boleznijo tipa 2 (pri kateri telo insulina ne more učinkovito izrabljati).
English: The Committee recommended that Liprolog be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Liprolog izda dovoljenje za promet.
English: The active substance in Liprolog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Slovenian: Zdravilno učinkovino v zdravilu Liprolog, insulin lispro, proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v bakterijo vstavi gen (DNK), s katerim lahko tvori insulin lispro.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne proizvaja dovolj insulina za vzdrževanje primerne koncentracije glukoze v krvi ali pri kateri telo ne more insulina učinkovito uporabljati.
English: Liprolog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Slovenian: Zdravilo Liprolog lahko povzroči hipoglikemijo (nizko raven glukoze v krvi) in se ne sme dajati bolnikom, katerih raven glukoze v krvi je že tako nizka.
English: For the full list of all side effects and restrictions with Liprolog, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Liprolog glejte navodilo za uporabo.
English: Liprolog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Slovenian: Zdravilo Liprolog 100 enot/ml se lahko daje tudi s kontinuirano infuzijo z insulinsko črpalko ali v veno.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Liprolog, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Why has Liprolog been approved?
Slovenian: Zakaj je bilo zdravilo Liprolog odobreno?
English: Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Slovenian: Zdravili Liprolog in Humulin R sta podobno učinkovali na nadzor sladkorne bolezni, kar so pokazale ravni HbA1c in ravni glukoze na tešče.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours).
Slovenian: V študijah so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako učinkovito je raven glukoze v krvi nadzorovana, in glukoze v krvi bolnika na tešče (izmerjene vsaj osem ur po zadnjem obroku).
English: Liprolog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.
Slovenian: Zdravilo Liprolog 200 enot/ml je treba injicirati pod kožo s peresnikom KwikPen, v katerem je pripravljeno za uporabo.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Liprolog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Slovenian: Odbor za zdravila za humano uporabo (CHMP) je zaključil, da so koristi zdravila Liprolog pri zdravljenju bolnikov s sladkorno boleznijo, ki potrebujejo insulin za vzdrževanje normalne homeostaze glukoze, pa tudi za začetno stabilizacijo sladkorne bolezni, večje od z njim povezanih tveganj.
English: The Liprolog range is comprised of fast-acting insulin solutions (Liprolog), longer-acting insulin suspensions (Liprolog Basal), and combinations of both in various proportions (Liprolog Mix):
Slovenian: Izdelki Liprolog vsebujejo raztopine insulinov s hitrim delovanjem (Liprolog), suspenzije insulinov z dolgotrajnejšim delovanjem (Liprolog Basal) ter kombinacije obeh v različnih razmerjih (Liprolog Mix):
English: Liprolog is a replacement insulin which is very similar to the insulin made by the body.
Slovenian: Zdravilo Liprolog je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja telo.
English: • Liprolog Basal: insulin lispro protamine suspension;
Slovenian: • Liprolog Basal: suspenzija insulina lispro-protamin;
English: The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Slovenian: Učinkovitost zdravila Liprolog so primerjali z učinkovitostjo zdravila Humulin R (topnega humanega insulina, nastalega s pomočjo tehnologije rekombinantne DNK), pri čemer so obe zdravili dodajali insulinom z dolgotrajnim delovanjem, ki se dajejo enkrat do dvakrat dnevno.
English: Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Slovenian: Insulin lispro je v zdravilu Liprolog na voljo v topni obliki, zaradi česar večinoma učinkuje takoj po injekciji, v zdravilu Liprolog Basal pa v obliki suspenzije protamina, ki se absorbira veliko počasneje in zato učinkuje dlje.
English: Liprolog is used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.
Slovenian: Zdravilo Liprolog se uporablja za zdravljenje odraslih in otrok s sladkorno boleznijo, ki potrebujejo insulin za nadzor sladkorja v krvi, vključno z bolniki, katerim je bila sladkorna bolezen šele diagnosticirana.
English: Liprolog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Slovenian: Zdravilo Liprolog se lahko uporablja z insulinom z daljšim delovanjem ali s sulfonilsečninami (skupino peroralnih zdravil za zdravljenje sladkorne bolezni).
English: Liprolog Mix, Liprolog Basal and Liprolog 200 units/ml should never be given into a vein.
Slovenian: Zdravil Liprolog Mix, Liprolog Basal in Liprolog 200 enot/ml se ne sme dajati v veno.
English: How has Liprolog been studied?
Slovenian: Kako je bilo zdravilo Liprolog raziskano?
English: Liprolog is supplied in vials, cartridges and prefilled pens (Liprolog KwikPen).
Slovenian: Na voljo je v vialah, vložkih ali napolnjenih injekcijskih peresnikih (Liprolog KwikPen).
English: Liprolog, Liprolog Basal and Liprolog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Slovenian: Zdravila Liprolog, Liprolog Basal in Liprolog Mix se dajejo pod kožo z injekcijo v nadlaket, stegno, zadnjico ali trebuh.
English: What is Liprolog?
Slovenian: Kaj je zdravilo Liprolog?
English: What is Liprolog used for?
Slovenian: Za kaj se zdravilo Liprolog uporablja?
English: Liprolog contains the active substance insulin lispro.
Slovenian: Zdravilo Liprolog vsebuje zdravilno učinkovino insulin lispro.
English: How is Liprolog used?
Slovenian: Kako se zdravilo Liprolog uporablja?
English: How does Liprolog work?
Slovenian: Kako zdravilo Liprolog deluje?
English: It can also be used on its own in:
Slovenian: Uporablja se lahko tudi samostojno pri:
English: This was converted into a full marketing authorisation on 20 November 2018.
Slovenian: To je bilo 20. novembra 2018 spremenjeno v običajno dovoljenje za promet.
English: Further information on Venclyxto can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Venclyxto.
Slovenian: Nadaljnje informacije o zdravilu Venclyxto so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Venclyxto.
English: Regarding safety, the medicine's side effects are considered acceptable.
Slovenian: Kar zadeva varnost, neželeni učinki zdravila veljajo za sprejemljive.
English: The starting dose is 20 mg daily and the dose is gradually increased over 5 weeks to 400 mg.
Slovenian: Začetni odmerek je 20 mg na dan, ta pa se v obdobju pet tednov postopoma povečuje do 400 mg.
English: Although there is a risk of tumour lysis syndrome, a complication that occurs when the cancer cells are being destroyed too quickly, this risk can be contained through preventive measures, such as increasing the dose gradually or reducing the dose, if needed.
Slovenian: Čeprav obstaja tveganje za sindrom tumorske lize, tj. zaplet, ki se pojavi, kadar se rakave celice prehitro uničujejo, se to tveganje lahko obvlada s preventivnimi ukrepi, kot sta postopno povečevanje odmerka ali zmanjšanje odmerka, če je potrebno.
English: Venclyxto received a conditional marketing authorisation valid throughout the EU on 5 December 2016.
Slovenian: Za zdravilo Venclyxto je bilo 5. decembra 2016 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: If the patient experiences certain side effects, treatment may be stopped temporarily or the dose reduced.
Slovenian: Če bolnik občuti določene neželene učinke, bo zdravljenje morda treba začasno prekiniti ali zmanjšati odmerek.
English: What measures are being taken to ensure the safe and effective use of Venclyxto?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Venclyxto?
English: Patients in this second study had all previously taken B-cell receptor pathway inhibitors.
Slovenian: Vsi bolniki v tej drugi študiji so predhodno prejemali zaviralce receptorske poti celic B.
English: This protein is present in high amounts in CLL cancer cells, where it helps the cells survive for longer in the body and makes them resistant to cancer medicines.
Slovenian: Ta beljakovina je v velikih količinah prisotna v rakavih celicah KLL, kjer celicam pripomore k daljšemu preživetju v telesu in jih naredi odporne proti zdravilom za zdravljenje raka.
English: The European Medicines Agency decided that Venclyxto's benefits outweigh its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da koristi zdravila Venclyxto odtehtajo njegova tveganja in da se lahko odobri za uporabo v EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Venclyxto 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 Venclyxto upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: A high response rate was also seen in patients whose previous treatment with ibrutinib or idelalisib failed.
Slovenian: Poleg tega so visoko stopnjo odziva opazili tudi pri bolnikih, pri katerih je bilo predhodno zdravljenje z ibrutinibom ali idelalisibom neuspešno.
English: Venclyxto (venetoclax)
Slovenian: Venclyxto (venetoklaks)
English: As for all medicines, data on the use of Venclyxto are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Venclyxto stalno spremljajo.
English: In these patients, Venclyxto is used when medicines known as B-cell receptor pathway inhibitors (ibrutinib and idelalisib) are not suitable or have failed.
Slovenian: Pri teh bolnikih se zdravilo Venclyxto uporablja, kadar zdravila, znana kot zaviralci receptorske poti celic B (ibrutinib in idelalisib), niso primerna ali niso bila uspešna.
English: Side effects reported with Venclyxto are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Venclyxto, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Venclyxto authorised in the EU?
Slovenian: Zakaj je zdravilo Venclyxto odobreno v EU?
English: In another study of 127 patients with or without 17p deletion or TP53 mutation, the response rate was 70%.
Slovenian: V drugi študiji s 127 bolniki z delecijo 17p ali mutacijo TP53 ali brez njiju je bila stopnja odziva 70 %.
English: For more information about using Venclyxto, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Venclyxto glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: A high proportion of patients respond to Venclyxto after other treatments have failed or are unsuitable.
Slovenian: Na zdravilo Venclyxto se odzove velik delež bolnikov, kadar druga zdravila niso uspešna ali niso primerna.
English: When Venclyxto is used on its own, treatment should continue for as long as the patient improves or remains stable and the side effects are tolerable.
Slovenian: Kadar se zdravilo Venclixto uporablja samostojno, je treba zdravljenje nadaljevati tako dolgo, dokler se stanje bolnika izboljšuje oziroma ostaja stabilno in dokler so neželeni učinki znosni.
English: Venclyxto should be taken for 24 months from day 1 of the first cycle of rituximab.
Slovenian: Zdravilo Venclixto je treba jemati 24 mesecev od prvega dne v prvem ciklusu zdravljenja z rituksimabom.
English: In a main study of 107 previously treated patients with CLL and 17p deletion, 75% responded partially or completely to Venclyxto.
Slovenian: V glavni študiji s 107 predhodno zdravljenimi bolniki s KLL in delecijo 17p se jih je 75 % delno ali popolnoma odzvalo na zdravilo Venclyxto.
English: Venclyxto is available as tablets (10, 50 and 100 mg) to be taken by mouth once a day with a meal.
Slovenian: Zdravilo Venclyxto je na voljo v obliki tablet (10 mg, 50 mg in 100 mg), ki se jemljejo peroralno enkrat na dan med obrokom.
English: An overview of Venclyxto and why it is authorised in the EU
Slovenian: Pregled zdravila Venclyxto in zakaj je odobreno v EU
English: Venclyxto can be used in combination with rituximab (another cancer medicine) in patients who have received at least one previous treatment.
Slovenian: Zdravilo Venclyxto se lahko uporablja v kombinaciji z rituksimabom (drugim zdravilom za zdravljenje raka) pri bolnikih, ki so bili zdravljeni že vsaj enkrat.
English: What is Venclyxto and what is it used for?
Slovenian: Kaj je zdravilo Venclyxto in za kaj se uporablja?
English: By attaching to Bcl-2 and blocking its actions, venetoclax causes the death of cancer cells and thereby slows down the progression of the disease.
Slovenian: Venetoklaks z vezavo na beljakovino Bcl-2 in zaviranjem njenega delovanja povzroči odmrtje rakavih celic in tako upočasni napredovanje bolezni.
English: • patients with particular genetic changes (17p deletion or TP53 mutation) that make them unsuitable for chemo-immunotherapy (a type of cancer treatment).
Slovenian: • bolnikih z določenimi genskimi spremembami (delecijo 17p ali mutacijo TP53), zaradi katerih niso primerni za kemoimunoterapijo (vrsta zdravljenja raka).
English: Venclyxto should be started and supervised by a doctor with experience of cancer medicines and can only be obtained with a prescription.
Slovenian: Zdravljenje z zdravilom Venclyxto mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravili za zdravljenje raka, predpisovanje in izdaja zdravila pa je le na recept.
English: • patients who do not have these genetic changes after treatments with chemo-immunotherapy and a B-cell receptor pathway inhibitor have both failed.
Slovenian: • bolnikih brez teh genskih sprememb, pri katerih zdravljenje s kemoimunoterapijo in zaviralcem receptorske poti celic B ni bilo uspešno.