FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that cancer cells cannot divide and eventually die.
Slovenian: To pomeni, da se celice raka ne morejo razmnoževati in sčasoma odmrejo.
English: The most common side effect seen in all types of cancer (in more than 1 patient in 10) is nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinek, opažen pri vseh oblikah raka (pri več kot 1 bolniku izmed 10), je navzeja (slabost).
English: It also reduces its effects on non-cancer tissues and cells, so it is less likely to cause some side effects.
Slovenian: Prav tako zmanjša učinke zdravila na nerakava tkiva in celice, zato je verjetnost, da povzroči določene neželene učinke, manjša.
English: This is a summary of the European public assessment report (EPAR) for Caelyx.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Caelyx.
English: The main measure of effectiveness was time until the disease got worse or, for Kaposi's sarcoma, the number of patients who responded to treatment.
Slovenian: Glavno merilo učinkovitosti je bil čas do poslabšanja bolezni, pri Kaposijevem sarkomu pa število bolnikov, ki so se odzvali na zdravljenje.
English: For more information about treatment with Caelyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Caelyx preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: It contains the active substance doxorubicin hydrochloride (2 mg/ml).
Slovenian: Vsebuje zdravilno učinkovino doksorubicinijev klorid (2 mg/ml).
English: For Kaposi's sarcoma, around 70% of the patients had a complete or partial response to treatment, with similar results in the study of patients who had been treated before.
Slovenian: Pri zdravljenju Kaposijevega sarkoma se je približno 70 % bolnikov popolnoma ali delno odzvalo na zdravljenje, podobni rezultati pa so bili doseženi tudi v študiji z bolniki, ki so se že prej zdravili.
English: It cannot be interchanged with other medicines containing doxorubicin hydrochloride.
Slovenian: Ne sme se zamenjevati z drugimi zdravili, ki vsebujejo doksorubicinijev klorid.
English: Caelyx is used to treat the following types of cancer in adults:
Slovenian: Zdravilo Caelyx se uporablja za zdravljenje naslednjih vrst raka pri odraslih:
English: The additional studies showed that Caelyx was also more effective than the comparator combinations.
Slovenian: Dodatne študije so pokazale, da je zdravilo Caelyx učinkovitejše od primerjanih kombinacij.
English: Caelyx doxorubicin hydrochloride
Slovenian: Caelyx doksorubicinijev klorid
English: Other very common side effects include palmar-plantar erythrodysaesthesia syndrome (redness and pain on the hands and feet), vomiting, stomatitis (inflammation of the lining of the mouth), rash, asthenia (weakness), low blood cell counts, loss of appetite, alopecia (hair loss), fatigue (tiredness), diarrhoea, constipation and mucositis (inflammation of the mouth and throat).
Slovenian: Drugi zelo pogosti neželeni učinki so sindrom palmarno-plantarne eritrodisestezije (pordelost in bolečine na dlaneh in stopalih), bruhanje, stomatitis (vnetje ustne sluznice), izpuščaj, astenija (šibkost), nizka raven krvnih celic, izguba teka, alopecija (izpadanje las), utrujenost, driska, zaprtost in mukozitis (vnetje v ustih in žrelu).
English: • metastatic breast cancer in patients at risk of heart problems.
Slovenian: • metastatskega raka dojk pri bolnikih s povečanim tveganjem za nastanek bolezni srca.
English: For Kaposi's sarcoma, the dose is 20 mg/m2 every two to three weeks for two to three months, and for multiple myeloma, it is 30 mg/m2 on day four of each three-week cycle of bortezomib treatment, for as long as the patient continues to benefit from the treatment and can tolerate it.
Slovenian: Za Kaposijev sarkom je odmerek 20 mg/m2 na vsaka dva do tri tedne v skupnem trajanju dva do tri mesece, za multipli mielom pa je odmerek 30 mg/m2 na četrti dan vsakega tritedenskega cikla zdravljenja z bortezomibom tako dolgo, dokler bolniku zdravljenje koristi in ga dobro prenaša.
English: However, patients receiving Caelyx were less likely to experience heart problems.
Slovenian: Vendar je bila pri bolnikih, ki so prejemali zdravilo Caelyx, verjetnost težav s srcem manjša.
English: Further studies compared Caelyx with the combination of doxorubicin, bleomycin and vincristine (other anticancer medicines) in 258 patients and with the combination of bleomycin and vincristine in 241 patients.
Slovenian: V dodatnih študijah so zdravilo Caelyx primerjali s kombinacijo doksorubicina, bleomicina in vinkristina (drugih zdravil proti raku) pri 258 bolnikih ter s kombinacijo bleomicina in vinkristina pri 241 bolnikih.
English: Caelyx is used in combination with bortezomib (another anticancer medicine).
Slovenian: Zdravilo Caelyx se uporablja v kombinaciji z bortezomibom (drugim zdravilom proti raku).
English: What benefit has Caelyx shown during the studies?
Slovenian: Kakšne koristi je zdravilo Caelyx izkazalo med študijami?
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 Caelyx.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Caelyx, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Caelyx must not be used to treat Kaposi's sarcoma that could be treated effectively with ‘local' treatments that only affect the site of the tumour or with whole-body alfa interferon treatment.
Slovenian: Zdravilo Caelyx se ne sme uporabljati za zdravljenje Kaposijevega sarkoma, ki bi ga bilo mogoče učinkovito zdraviti „lokalno“ z zdravili, ki delujejo le na mesto tumorja, ali z interferonom alfa, ki deluje na celotno telo.
English: The recommended starting dose of Caelyx for breast or ovarian cancer is 50 mg per square metre body surface area (calculated using the patient's height and weight) every four weeks for as long as the disease does not get worse and the patient can tolerate the treatment.
Slovenian: Priporočeni začetni odmerek zdravila Caelyx za zdravljenje raka dojk in raka jajčnikov je 50 mg na kvadratni meter telesne površine (ki se izračuna na podlagi telesne višine in mase bolnika) enkrat na vsake štiri tedne, dokler se bolezen ne poslabša in bolnik dobro prenaša zdravljenje.
English: • Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS) who have very damaged immune systems and extensive sarcoma on the skin, the moist body surfaces or the internal organs;
Slovenian: • Kaposijevega sarkoma (raka žil) pri bolnikih s sindromom pridobljene imunske pomanjkljivosti (aidsom), ki imajo zelo prizadet imunski sistem in razširjen sarkom na koži, vlažnih telesnih površinah ali notranjih organih;
English: Caelyx is used on its own for this disease;
Slovenian: Za to bolezen se zdravilo Caelyx uporablja samostojno;
English: • multiple myeloma (a cancer of the cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already undergone or are unsuitable for a bone marrow transplant.
Slovenian: • multiplega mieloma (raka celic v kostnem mozgu) pri bolnikih z napredujočo boleznijo, ki so prejeli najmanj eno drugačno terapijo in so že prestali presaditev kostnega mozga ali zanjo niso primerni.
English: The CHMP decided that Caelyx's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Caelyx večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For multiple myeloma, adding Caelyx to bortezomib increased the time until the disease got worse from 6.5 to 9.3 months.
Slovenian: Z dodajanjem zdravila Caelyx k bortezomibu za zdravljenje multiplega mieloma se je čas do poslabšanja bolezni podaljšal s 6,5 na 9,3 meseca.
English: Caelyx accumulates in areas in the body where the blood vessels have an abnormal shape, such as within tumours, where its action is concentrated.
Slovenian: Zdravilo Caelyx se kopiči v delih telesa, kjer imajo žile neobičajno obliko, npr. v tumorjih, v katerih se njegovo delovanje skoncentrira.
English: Caelyx is not recommended for patients whose spleen has been removed.
Slovenian: Zdravljenje z zdravilom Caelyx ni priporočljivo za bolnike, ki jim je bila odstranjena vranica.
English: Caelyx should not be used in people who may be hypersensitive (allergic) to doxorubicin hydrochloride or any of the other ingredients.
Slovenian: Zdravila Caelyx ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) doksorubicinijev klorid ali katero koli drugo sestavino zdravila.
English: In the treatment of breast cancer, Caelyx was as effective as standard doxorubicin: the time until the disease got worse was around 7.5 months in both groups.
Slovenian: Zdravilo Caelyx je bilo pri zdravljenju metastatskega raka dojk enako učinkovito kot običajni doksorubicin: čas do poslabšanja bolezni je bil v obeh skupinah približno 7,5 meseca.
English: Other information about Caelyx
Slovenian: Druge informacije o zdravilu Caelyx:
English: In Caelyx, it is contained in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Slovenian: V zdravilu Caelyx se nahaja v „pegiliranih liposomih“ (majhnih maščobnih kroglicah, ki so prevlečene s snovjo, imenovano polietilenglikol).
English: For AIDS-related Kaposi's sarcoma, the effectiveness of Caelyx was studied in two main studies involving 384 patients, including 77 who had received treatment before.
Slovenian: Učinkovitost zdravila Caelyx pri z aidsom povezanem Kaposijevem sarkomu so proučevali v dveh glavnih študijah, ki sta vključevali 384 bolnikov, vključno s 77 bolniki, ki so se zdravili že prej.
English: For the full list of all side effects reported with Caelyx, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Caelyx, glejte navodilo za uporabo.
English: • advanced ovarian cancer (cancer of the ovary) in women whose previous treatment including a platinum-based anticancer medicine has stopped working;
Slovenian: • napredovalega raka jajčnikov pri bolnicah, pri katerih predhodno zdravljenje, vključno s platinsko kemoterapijo, ni bilo več uspešno;
English: Caelyx has been studied in a total of 2,512 patients in seven main studies.
Slovenian: Zdravilo Caelyx so proučevali v sedmih glavnih študijah, v katere je bilo vključenih skupno 2512 bolnikov.
English: What is the risk associated with Caelyx?
Slovenian: Kakšna tveganja so povezana z zdravilom Caelyx?
English: Why has Caelyx been approved?
Slovenian: Zakaj je bilo zdravilo Caelyx odobreno?
English: The active substance in Caelyx, doxorubicin hydrochloride, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Slovenian: Zdravilna učinkovina zdravila Caelyx, doksorubicinijev klorid, je citotoksično zdravilo iz skupine „antraciklinov“.
English: For multiple myeloma, the effectiveness of the combination of Caelyx and bortezomib was compared with that of bortezomib alone in 646 patients.
Slovenian: Učinkovitost kombinacije zdravila Caelyx in bortezomiba pri multiplem mielomu so primerjali s samostojno uporabo bortezomiba pri 646 bolnikih.
English: For ovarian cancer, Caelyx was as effective as topotecan in extending time until the disease got worse.
Slovenian: Pri raku jajčnikov je bilo zdravilo Caelyx glede podaljšanja časa do poslabšanja bolezni enako učinkovito kot topotekan.
English: For metastatic breast cancer, Caelyx has been compared with standard doxorubicin in one main study involving 509 women.
Slovenian: Uporabo zdravila Caelyx pri metastatskem raku dojk so v glavni študiji, v katero je bilo vključenih 509 žensk, primerjali z običajnim doksorubicinom.
English: For advanced ovarian cancer, Caelyx has been compared with topotecan (another anticancer medicine) in one study involving 474 women who had received platinum-based chemotherapy in the past.
Slovenian: Uporabo zdravila Caelyx pri napredovalem raku jajčnikov so primerjali s topotekanom (drugim zdravilom proti raku) v študiji, v katero je bilo vključenih 474 žensk, ki so se prej zdravile s platinsko kemoterapijo.
English: The side effects with Caelyx depend on the type of cancer being treated.
Slovenian: Neželeni učinki zdravila Caelyx so odvisni od vrste raka, ki se zdravi.
English: Treatment should be stopped or the dose reduced in patients who experience certain side effects or who have liver problems.
Slovenian: Pri bolnikih, pri katerih se pojavijo določeni neželeni učinki, in pri tistih, ki imajo težave z jetri, je treba zdravljenje prekiniti ali zmanjšati odmerek.
English: Caelyx should be given under the supervision of a doctor who is qualified in the use of cytotoxic (cellkilling) medicines.
Slovenian: Zdravilo Caelyx se sme uporabljati le pod nadzorom zdravnika, ki je usposobljen za dajanje citotoksičnih zdravil (zdravil, ki uničujejo celice).
English: Caelyx is concentrate to be made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Caelyx je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: What is Caelyx?
Slovenian: Kaj je zdravilo Caelyx?
English: How has Caelyx been studied?
Slovenian: Kako je bilo zdravilo Caelyx raziskano?
English: What is Caelyx used for?
Slovenian: Za kaj se zdravilo Caelyx uporablja?
English: How does Caelyx work?
Slovenian: Kako zdravilo Caelyx deluje?
English: How is Caelyx used?
Slovenian: Kako se zdravilo Caelyx uporablja?
English: Further information on Kineret can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Kineret je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The improvement was maintained over a follow-up period of up to 60 months.
Slovenian: To izboljšanje se je ohranilo v obdobju spremljanja bolnikov do 60 mesecev.
English: • cryopyrin-associated periodic syndromes (CAPS).
Slovenian: • s kriopirinom povezanih periodičnih sindromov (CAPS).
English: In addition levels of amyloid A, a marker of inflammation were also reduced.
Slovenian: Poleg tega so se znižale tudi ravni amiloida A, označevalca vnetja.
English: Kineret received a marketing authorisation valid throughout the European Union on 8 March 2002.
Slovenian: Za zdravilo Kineret je bilo 8. marca 2002 izdano dovoljenje za promet, veljavno po vsej EU.
English: What is Kineret and what is it used for?
Slovenian: Kaj je zdravilo Kineret in za kaj se uporablja?
English: An overview of Kineret and why it is authorised in the EU
Slovenian: Pregled zdravila Kineret in zakaj je odobreno v EU
English: Other information about Kineret
Slovenian: Druge informacije o zdravilu Kineret
English: What measures are being taken to ensure the safe use of Kineret?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Kineret?
English: As for all medicines, data on the use of Kineret are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Kineret stalno spremljajo.
English: Kineret is a medicine that is used to treat:
Slovenian: Kineret je zdravilo, ki se uporablja za zdravljenje:
English: What benefits of Kineret have been shown in studies?
Slovenian: Kakšne koristi zdravila Kineret so se pokazale v študijah?
English: Patients either received Kineret or another type of medicine, called a DMARD.
Slovenian: Bolniki so prejemali zdravilo Kineret ali drugo vrsto zdravila, imenovano DMARD.
English: Side effects reported with Kineret are carefully evaluated and any necessary action is taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Kineret, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: However, because of the way the study was designed, the results were considered insufficient to support the use of the medicine on its own.
Slovenian: Vendar zaradi načina zasnove študije te ugotovitve ne štejejo kot zadosten dokaz v podporo uporabi tega zdravila kot samostojnega zdravila.
English: Kineret has been studied in three main studies involving a total of 1,388 patients with rheumatoid arthritis.
Slovenian: Zdravilo Kineret so raziskovali v treh glavnih študijah, ki so vključevale skupaj 1 388 bolnikov z revmatoidnim artritisom.
English: The recommended dose of Kineret for rheumatoid arthritis is 100 mg once a day, given at around the same time each day.
Slovenian: Priporočeni odmerek zdravila Kineret pri revmatoidnem artritisu je 100 mg enkrat na dan, ki se daje vsak dan ob približno istem času.
English: The injection site should be varied with each dose to avoid discomfort.
Slovenian: Mesto injiciranja je treba z vsakim odmerkom spremeniti, da bi se izognili neugodju.
English: Severe disabilities such as deafness and loss of vision may also occur;
Slovenian: Prav tako lahko pride do resne prizadetosti, kot sta naglušnost in okvara vida;
English: Results showed a significant and rapid improvement in symptoms, with a fall in average symptom score from 4.5 to 0.8 within 3 days of starting treatment.
Slovenian: Rezultati so pokazali znatno in hitro izboljšanje simptomov, in sicer je povprečna ocena simptomov v treh dneh po začetku zdravljenja padla s 4,5 na 0,8.
English: Why is Kineret authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Kineret odobreno v EU?
English: The Agency recommended that Kineret be given marketing authorisation.
Slovenian: Priporočila je, da se zanj izda dovoljenje za promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kineret 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 Kineret upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: • signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults.
Slovenian: • znakov in simptomov revmatoidnega artritisa (obolenja imunskega sistema, ki povzroča vnetje sklepov) pri odraslih.
English: Although patients with Still's disease had a higher risk of liver problems, this risk was considered to be outweighed by the medicine's benefits.
Slovenian: Čeprav so imeli bolniki s Stillovo boleznijo večje tveganje za težave z jetri, je bilo ocenjeno, da koristi zdravila to tveganje odtehtajo.
English: What are the risks associated with Kineret?
Slovenian: Kakšna tveganja so povezana z zdravilom Kineret?
English: Results showed that Kineret was more effective than placebo when used as an add-on to methotrexate.
Slovenian: Rezultati so pokazali, da je bilo zdravilo Kineret učinkovitejše od placeba, če se je uporabljalo kot dodatek metotreksatu.
English: Patients were given Kineret at a starting dose of 1 to 2 mg per kg body-weight daily, increased after a month if necessary.
Slovenian: Bolniki so prejemali zdravilo Kineret v začetnem odmerku 1 do 2 mg na kilogram telesne mase na dan, po mesecu dni pa se je ta odmerek po potrebi povečal.
English: It blocks the receptors for a chemical messenger in the body called interleukin 1.
Slovenian: Zavira receptorje za kemični prenašalec v telesu, ki se imenuje interlevkin 1.
English: The first study included 468 patients, some of whom had taken other medicines for their disease in the past, and who were given either Kineret on its own or placebo.
Slovenian: V prvo študijo je bilo vključenih 468 bolnikov, od katerih so nekateri v preteklosti jemali druga zdravila proti tej bolezni, v študiji pa so prejemali bodisi zdravilo Kineret kot samostojno zdravilo bodisi placebo.
English: By attaching to the receptors that interleukin 1 would normally attach itself to, anakinra blocks the activity of interleukin 1, helping to relieve the symptoms of these diseases.
Slovenian: Anakinra z vezavo na receptorje, na katere se običajno veže interlevkin 1, prepreči delovanje interlevkina 1 in tako ublaži simptome teh bolezni.
English: In the other two studies, Kineret was used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient's weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day.
Slovenian: V drugih dveh študijah so zdravilo Kineret uporabili kot dodatek k obstoječemu zdravljenju, ki je vključevalo metotreksat: v prvi študiji, ki je vključevala 419 bolnikov, so uporabili različne odmerke zdravila Kineret glede na telesno maso bolnikov, v drugi študiji, v kateri je sodeloval 501 bolnik, pa so bolniki zdravilo Kineret prejemali v stalnem odmerku 100 mg enkrat na dan.
English: The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘human interleukin 1 receptor antagonist'.
Slovenian: Učinkovina v zdravilu Kineret, anakinra, je kopija naravne človeške beljakovine, imenovane „antagonist človeškega receptorja za interlevkin 1“.
English: Results showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of the disease, measured by the doctor and the patient using the ‘American College of Rheumatology' score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C reactive protein in the blood (a marker of inflammation).
Slovenian: Rezultati so pokazali, da so določeni odmerki zdravila Kineret pri zmanjševanju simptomov bolezni učinkovitejši od placeba, kot sta simptome ocenjevala zdravnik in bolnik na podlagi lestvice ameriškega inštituta za revmatologijo (American College of Rheumatology), ki vključuje merjenje števila bolečih ali občutljivih sklepov, aktivnosti bolezni, bolečine, gibalne nezmožnosti in ravni C-reaktivne beljakovine v krvi (označevalca vnetja).
English: For Still's disease, three small studies have been carried out.
Slovenian: Pri bolnikih s Stillovo boleznijo so izvedli tri manjše študije.
English: The most common side effects with Kineret (which may affect more than 1 patient in 10) are headache, injection site reactions (redness, bruising, pain and inflammation), and increase in blood cholesterol.
Slovenian: Najpogostejši neželeni učinki zdravila Kineret (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, reakcije na mestu injiciranja (rdečina, podplutba, bolečina in vnetje) in povišane ravni holesterola v krvi.
English: A second study in 24 children showed similar results: 67 % had at least a 30% reduction in symptoms after one month compared with 8 % given placebo.
Slovenian: Druga študija pri 24 otrocih je pokazala podobne rezultate: pri 67 % so se simptomi po enem mesecu zmanjšali za vsaj 30 %, v primerjavi z 8 % tistih, ki so prejemali placebo.
English: Kineret must not be started in patients who have neutropenia (low levels neutrophils, a type of blood cell that fights infection).
Slovenian: Zdravilo se ne sme uvesti pri bolnikih z nevtropenijo (nizkimi vrednostmi nevtrofilcev, vrste krvnih celic, ki se borijo proti okužbam).
English: Kineret should be used with caution in patients who have severely reduced liver function or moderately reduced kidney function.
Slovenian: Zdravilo Kineret je treba uporabljati previdno pri bolnikih s hudo okvaro delovanja jeter ali zmerno okvaro delovanja ledvic.
English: The active substance in Kineret, anakinra, is an immunosuppressive medicine (a medicine that reduces the activity of the immune system).
Slovenian: Učinkovina v zdravilu Kineret, anakinra, je imunosupresivno zdravilo (zdravilo za zaviranje delovanja imunskega sistema).