FrancophonIA/ELRC3.0 huggingface dataset:
English: A fifth study showed that Lifmior on its own or in combination with methotrexate was more effective than methotrexate alone.
Slovenian: Peta študija je pokazala, da je samo zdravilo Lifmior ali skupaj z metotreksatom učinkovitejše kot samo metotreksat.
English: Lifmior is given as an injection under the skin.
Slovenian: Zdravilo Lifmior se daje z injiciranjem pod kožo.
English: Further studies have been carried out in over 2,300 patients with other inflammatory diseases (juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and axial spondyloarthritis).
Slovenian: Nadaljnje študije so bile izvedene na več kot 2 300 bolnikih z drugimi vnetnimi boleznimi (juvenilni idiopatski artritis, psoriatični artritis, ankilozirajoči spondilitis, psoriaza v plakih in aksialni spondiloartritis).
English: Lifmior must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections.
Slovenian: Zdravila Lifmior ne smejo jemati bolniki, ki imajo sepso ali pri katerih obstaja nevarnost sepse (kadar bakterije in toksini krožijo v krvi in poškodujejo organe), ali bolniki z okužbami.
English: It is not intended to provide practical advice on how to use Lifmior.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What is Lifmior and what is it used for?
Slovenian: Kaj je zdravilo Lifmior in za kaj se uporablja?
English: The active substance in Lifmior, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor (TNF).
Slovenian: Zdravilna učinkovina v zdravilu Lifmior, etanercept, je beljakovina, katere namen je zavirati delovanje snovi, ki se imenuje dejavnik tumorske nekroze (TNF).
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Slovenian: Etanercept z zaviranjem delovanja TNF zmanjša vnetje in druge simptome bolezni.
English: The most common side effects with Lifmior (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Slovenian: Najpogostejši neželeni učinki zdravila Lifmior (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (vključno s krvavitvami, modricami, rdečico, srbečico, bolečino in otekanjem) in okužbe (vključno s prehladi ter vnetji pljuč, mehurja in kože).
English: What is the risk associated with Lifmior?
Slovenian: Kakšna tveganja so povezana z zdravilom Lifmior?
English: Patients developing a serious infection should stop Lifmior treatment.
Slovenian: Bolniki, pri katerih se pojavi resna okužba, morajo zdravilo Lifmior prenehati jemati.
English: In a fourth study of rheumatoid arthritis patients who had not taken methotrexate before, those receiving 25 mg Lifmior twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months.
Slovenian: V četrti študiji so bolniki z revmatoidnim artritisom, ki prej niso jemali metotreksata in so dvakrat tedensko prejemali 25 mg zdravila Lifmior, po 12 oziroma 24 mesecih imeli manj poškodb sklepov kot tisti, ki so jemali samo metotreksat.
English: The company that markets Lifmior will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.
Slovenian: Družba, ki trži zdravilo Lifmior, bo zagotovila izobraževalno gradivo za zdravnike, ki naj bi ga predpisovali, da bodo bolnike poučili o pravilni uporabi napolnjenega peresnika in mu izročili kartico s posebnim opozorilom za bolnike, da lahko prepoznajo resne neželene učinke in vedo, kdaj poiskati nujno zdravniško pomoč.
English: Why is Lifmior approved?
Slovenian: Zakaj je bilo zdravilo Lifmior odobreno?
English: Three of these studies in patients who had taken arthritis medicines in the past showed about two-thirds of the patients who received Lifmior had a reduction in symptoms of 20% or more after three months based on a standard rating score (ACR 20).
Slovenian: Tri od teh študij na bolnikih, ki so v preteklosti jemali zdravila proti artritisu, so pokazale, da so se pri približno dveh tretjinah bolnikov, ki so jemali zdravilo Lifmior, po treh mesecih simptomi na podlagi standardne ocenjevalne lestvice (ACR 20) zmanjšali za 20 % ali več .
English: Several studies have shown that Lifmior is more effective at reducing symptoms of inflammatory conditions than placebo (a dummy treatment) or a comparator medicine.
Slovenian: Različne študije so pokazale, da zdravilo Lifmior učinkoviteje zmanjšuje simptome vnetij kot placebo (zdravilo brez zdravilne učinkovine) ali primerjalno zdravilo.
English: Lifmior is effective at reducing symptoms in several inflammatory conditions and its side effects are considered manageable.
Slovenian: Zdravilo Lifmior učinkovito blaži različne simptome pri številnih vnetjih, njegovi neželeni učinki pa se štejejo za obvladljive.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lifmior have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lifmior upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: It contains the active substance etanercept.
Slovenian: Vsebuje zdravilno učinkovino etanercept.
English: Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Lifmior is used for.
Slovenian: Zdravljenje začne in nadzoruje zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se uporablja zdravilo Lifmior.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Lifmior is used to treat.
Slovenian: Ta snov sodeluje pri nastanku vnetij in je v visokih koncentracijah prisotna pri bolnikih z boleznimi, za katerih zdravljenje se uporablja zdravilo Lifmior.
English: • certain forms of juvenile idiopathic arthritis (inflammation of joints in children and adolescents)
Slovenian: • nekaterih oblik juvenilnega idiopatskega artritisa (vnetja sklepov pri otrocih in mladoletnikih);
English: For more information about treatment with Lifmior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lifmior preberite navodilo za uporabo (ki je tudi del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: These studies also showed that Lifmior produced a greater improvement in symptoms than placebo after three to four months using various standard rating scores such as ACR, ASAS and PASI.
Slovenian: Tudi te študije so pokazale, da so se po treh do štirih mesecih pri bolnikih, ki so jemali zdravilo Lifmior, simptomi bolj izboljšali kot pri bolnikih, ki so jemali placebo, kar je bilo ugotovljeno na podlagi različnih standardnih ocenjevalnih lestvic, kot so ACR, ASAS in PASI.
English: For detailed information on the use of Lifmior in all conditions, see the summary of product characteristics (also part of the EPAR).
Slovenian: Več informacij o uporabi zdravila Lifmior za vsa obolenja je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: For practical information about using Lifmior, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lifmior naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Lifmior is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough.
Slovenian: Zdravilo Lifmior se uporablja predvsem za huda do srednje huda bolezenska stanja ali zaradi neuspešnosti drugih vrst zdravljenja.
English: For the full list of all side effects reported with Lifmior, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Lifmior, glejte navodilo za uporabo.
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children
Slovenian: • psoriaze v plakih (bolezni, ki povzroča rdeče luskaste lise na koži) pri odraslih in otrocih;
English: How is Lifmior used?
Slovenian: Kako se zdravilo Lifmior uporablja?
English: • psoriatic arthritis (psoriasis with inflammation of the joints) in adults
Slovenian: • psoriatičnega artritisa (psoriaze z vnetjem sklepov) pri odraslih;
English: How does Lifmior work?
Slovenian: Kako zdravilo Lifmior deluje?
English: • rheumatoid arthritis (a disease causing inflammation of the joints) alone or with methotrexate in adults
Slovenian: • revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov) pri odraslih, pri čemer se uporablja samostojno ali skupaj z metotreksatom;
English: • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults
Slovenian: • ankilozirajočega spondilitisa (bolezni, ki povzroča vnetje sklepov v hrbtenici) pri odraslih;
English: Educational material for the pharmacists should highlight the following:
Slovenian: Izobraževalno gradivo za farmacevte mora poudariti naslednje:
English: The Member States should ensure that, the MAH provides all physicians, pharmacists and patients expected to prescribe/dispense/use Instanyl with educational material regarding the correct and safe use of the product.
Slovenian: Države članice morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom oskrbi vse zdravnike, farmacevte in bolnike, ki naj bi predpisovali/izdajali/uporabljali zdravilo Instanyl z izobraževalnim gradivom glede pravilne in varne uporabe zdravila.
English: • Not to use Instanyl nasal spray to treat any other short-term pain or pain status.
Slovenian: - zdravilo Instanyl pršila za nos se ne uporablja za zdravljenje drugih kratkotrajnih bolečin ali bolečinskih stanj
English: The Member States shall agree the final educational material with the Marketing Authorisation Holder (MAH) prior to launch of the multi dose and the single dose product in their territory.
Slovenian: Države članice se z imetnikom dovoljenja za promet z zdravilom dogovorijo o končnem izobraževalnem gradivu pred uvajanjem večodmernega in enoodmernega zdravila na svoje tržišče.
English: • Not to use Instanyl nasal spray for treatment of more than four breakthrough cancer pain episodes a day
Slovenian: - zdravilo Instanyl pršila za nos se ne uporablja za zdravljenje več kot štirih epizod prebijajoče bolečine zaradi raka na dan
English: • Instanyl nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Slovenian: - Instanyl pršilo za nos je indicirano le za obvladovanje prebijajoče bolečine pri odraslih, ki že prejemajo vzdrževalno opioidno zdravljenje za kronične bolečine zaradi raka
English: • Information about dose counting scheme included in the labelling and the educational material for the multi-dose nasal spray
Slovenian: - informacije o shemi štetja odmerkov, ki so vključene v označevanje in izobraževalna gradiva za večodmerno pršilo za nos
English: • The prescribers of Instanyl nasal spray must critically select the patients and counsel them on:
Slovenian: - Predpisovalci zdravila Instanyl pršila za nos morajo kritično izbirati bolnike in jim svetovati o: - navodilu za uporabo pršila za nos
English: • Only to use Instanyl nasal spray if they have received the proper information regarding the use of the device and the safety precautions from the prescriber and/or the pharmacist.
Slovenian: - Instanyl pršilo za nos uporabljati samo, če jih je predpisovalec in/ali farmacevt seznanil z ustreznimi informacijami glede uporabe pršila in previdnostnimi ukrepi
English: • That for the multi-dose nasal spray all unused devices or empty containers should be returned systematically according to the local regulation.
Slovenian: - da je pri večodmernem pršilu za nos treba vsa neuporabljena pršila ali prazne vsebnike sistematično vračati v skladu z lokalnimi predpisi - da je pri enoodmernem pršilu za nos treba vsa neuporabljena pršila sistematično vračati v skladu z lokalnimi predpisi - predpisovalec mora uporabiti kontrolni seznam za predpisovalce
English: • Instructions for opening and closing of the child-resistant box (for the multi-dose nasal spray) or blister (for the single-dose nasal spray)
Slovenian: - navodila za odpiranje in zapiranje škatle, ki je varna za otroke (za večodmerno pršilo za nos) ali
English: • The Instanyl nasal spray dose strengths cannot be compared with other Fentanyl products.
Slovenian: - Jakosti odmerkov zdravila Instanyl pršilo za nos ni mogoče primerjati z drugimi zdravili, ki vsebujejo fentanil - navodila za uporabo pršila za nos
English: • The pharmacist must be familiar with the educational material of Instanyl nasal spray before using it in his/her organisation.
Slovenian: - Farmacevt mora biti pred uporabo zdravila v svoji ustanovi seznanjen z izobraževalnimi gradivi o zdravilu Instanyl pršilo za nos
English: • Only to use Instanyl nasal spray if they have been experiencing breakthrough cancer pain episodes.
Slovenian: - zdravilo Instanyl pršilo za nos se lahko uporablja samo, če bolniki preživljajo epizode prebijajočih bolečin zaradi raka
English: • For the multi-dose nasal spray all unused devices or empty containers should be returned systematically according to the local regulation.
Slovenian: - za večodmerno pršilo za nos: vsa neuporabljena pršila ali prazne vsebnike je treba sistematično vračati v skladu z lokalnimi predpisi - za enoodmerno pršilo za nos: vsa neuporabljena pršila je treba sistematično vračati v skladu z lokalnimi predpisi Izobraževalno gradivo za zdravnike mora vsebovati naslednje: - Instanyl pršilo za nos smejo predpisati samo zdravniki, ki imajo izkušnje z vodenjem opioidnega zdravljenja pri bolnikih z rakom
English: • The pharmacist must inform the patients that in order to prevent theft and misuse of Instanyl nasal spray they have to keep it in a safe place to avoid misuse and diversion.
Slovenian: - farmacevt mora obvestiti bolnika, da je treba zdravilo Instanyl pršilo za nos zaradi preprečevanja kraje in zlorabe shranjevati na varnem mestu, kjer ni možna zloraba ali napačna uporaba - za večodmerno pršilo za nos: vsa neuporabljena pršila ali prazne vsebnike je treba sistematično vračati v skladu z lokalnimi predpisi - za enoodmerno pršilo za nos: vsa neuporabljena pršila je treba sistematično vračati v skladu z lokalnimi predpisi - farmacevt mora uporabiti kontrolni seznam za farmacevte
English: Kivexa has been studied in three main studies involving a total of 1,230 patients.
Slovenian: Zdravilo Kivexa so raziskali v treh glavnih študijah, v katere je bilo vključenih skupno 1 230 bolnikov.
English: The main measure of effectiveness was the change in the level of HIV in the blood (viral load) after 24 or 48 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni virusa HIV v krvi (virusnega bremena) po 24 oziroma 48 tednih zdravljenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kivexa on 17 December 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kivexa, veljavno po vsej Evropski uniji, izdala 17. decembra 2004.
English: What measures are being taken to ensure the safe and effective use of Kivexa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kivexa?
English: The full EPAR for Kivexa 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 Kivexa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kivexa
Slovenian: Druge informacije o zdravilu Kivexa
English: This document is a summary of the European public assessment report (EPAR) for Kivexa.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kivexa.
English: In the first study, 66% (253 out of 384) of the patients taking abacavir once a day had viral loads below 50 copies/ml after 48 weeks of treatment, compared with 68% (261 out of 386) of the patients taking it twice a day.
Slovenian: V prvi študiji je po 48 tednih zdravljenja 66 % (253 od 384) bolnikov, ki so jemali abakavir enkrat na dan, imelo virusno breme pod 50 kopijami/ml v primerjavi z 68 % (261 od 386) bolnikov, ki so ga jemali dvakrat na dan.
English: Both active substances have been available in the European Union (EU) since the late 1990s: abacavir has been authorised as Ziagen since 1999, and lamivudine has been authorised as Epivir since 1996.
Slovenian: Obe zdravilni učinkovini sta v Evropski uniji (EU) na voljo od poznih devetdesetih let prejšnjega stoletja: abakavir je odobren kot zdravilo Ziagen od leta 1999, lamivudin pa kot zdravilo Epivir od leta 1996.
English: For more information about treatment with Kivexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kivexa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: A risk management plan has been developed to ensure that Kivexa is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Kivexa je bil pripravljen načrt obvladovanja tveganj.
English: Kivexa abacavir and lamivudine
Slovenian: Kivexa abakavir in lamivudin
English: In addition, the company that makes Kivexa will provide educational material for all doctors who are expected to prescribe this medicine to increase awareness of the risk of hypersensitivity reactions and to provide guidance on how to manage it.
Slovenian: Poleg tega bo družba, ki izdeluje zdravilo Kivexa, pripravila izobraževalno gradivo za vse zdravnike, ki bodo predpisovali zdravilo, in tako povečala ozaveščenost o tveganjih za preobčutljivostne reakcije ter zagotovila smernice za njihovo obvladovanje.
English: Kivexa is a medicine that contains two active substances, abacavir (600 mg) and lamivudine (300 mg).
Slovenian: Kivexa je zdravilo, ki vsebuje dve zdravilni učinkovini, abakavir (600 mg) in lamivudin (300 mg).
English: Hypersensitivity reactions occur in patients taking Kivexa, usually within the first six weeks of treatment, and can be life-threatening.
Slovenian: Preobčutljivostne reakcije se pojavijo pri približno 3 % bolnikov, ki jemljejo zdravilo Kivexa, običajno v prvih šestih tednih zdravljenja, in so lahko smrtno nevarne.
English: The CHMP decided that Kivexa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Kivexa večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Both doses of abacavir, taken in combination with lamivudine and other antiviral medicines, were equally effective in reducing viral loads.
Slovenian: Oba odmerka abakavirja v kombinaciji z lamivudinom in drugimi protivirusnimi zdravili sta bila enako učinkovita pri zniževanju virusnega bremena.
English: Kivexa does not cure HIV infection or AIDS, but can delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: What benefit has Kivexa shown during the studies?
Slovenian: Kakšne koristi je zdravilo Kivexa izkazalo med študijami?
English: Kivexa is used in combination with at least one other antiviral medicine to treat adults and children weighing at least 25 kg who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Kivexa se uporablja v kombinaciji z vsaj še enim protivirusnim zdravilom za zdravljenje odraslih in otrok, ki tehtajo najmanj 25 kg, okuženih z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Kivexa, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Kivexa v kombinaciji z vsaj enim drugim zdravilom za zdravljenje okužbe z virusom HIV zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
English: Therefore, the studies compared abacavir taken at a dose of 600 mg once a day and at a dose of 300 mg twice a day, in combination with lamivudine and one or two other antiviral medicines.
Slovenian: V študijah so zato primerjali abakavir v odmerku 600 mg enkrat na dan z odmerkom 300 mg dvakrat na dan v kombinaciji z lamivudinom ter enim ali dvema drugima protivirusnima zdraviloma.
English: Kivexa should be prescribed by a doctor who has experience in the management of HIV infection.
Slovenian: Zdravilo Kivexa lahko predpiše le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
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 Kivexa.
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: The most common side effects with Kivexa (seen in between 1 and 10 patients in 100) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal pain (stomach ache), headache, arthralgia (joint pain), muscle disorders, cough, nasal symptoms (nose problems, such as irritation and runny nose), fever, lethargy (lack of energy), tiredness, insomnia (difficulty sleeping), malaise (feeling unwell), loss of appetite and alopecia (hair loss).
Slovenian: Najpogostejši neželeni učinki zdravila Kivexa (opaženi pri 1 do 10 bolnikov od 100) so preobčutljivost (alergijske reakcije), izpuščaj, navzeja (slabost), bruhanje, driska, bolečine v trebuhu, glavobol, artralgija (bolečine v sklepih), mišična obolenja, kašelj, simptomi v nosu (težave z nosom, kot sta draženje in izcedek), povišana telesna temperatura, letargija (pomanjkanje energije), utrujenost, nespečnost, slabo počutje, izguba teka in alopecija (izpadanje las).
English: Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, dyspnoea (difficulty breathing), cough, lethargy, malaise, headache, signs of liver damage in the blood and myalgia (muscle pain).
Slovenian: Med simptomi sta skoraj vedno povišana telesna temperatura ali izpuščaj, zelo pogosto pa tudi slabost, bruhanje, driska, bolečine v trebuhu, dispneja (oteženo dihanje), kašelj, letargija, slabo počutje, glavobol, znaki obolenja jeter v krvi in mialgija (bolečine v mišicah).
English: Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Kivexa.
Slovenian: Bolniki s tem genom so izpostavljeni višjemu tveganju za pojav alergijske reakcije na abakavir, zato ne smejo jemati zdravila Kivexa.
English: Two studies used the active substances taken as separate medicines, while the third used a combination tablet for the once-daily dose.
Slovenian: V dveh študijah so primerjali zdravilni učinkovini kot samostojni zdravili, v tretji pa so proučevali kombinacijo tablet za enkratni dnevni odmerek.