natgillin/translations-raw huggingface dataset:
An overview of Poteligeo and why it is authorised in the EU
Pregled zdravila Poteligeo in zakaj je odobreno v EU
The most commonly reported serious reactions are pneumonia (infection of the lungs), fever, infusion-related reactions and cellulitis (inflammation of the deep skin tissue).
Resne reakcije, o katerih so poročali najpogosteje, so pljučnica (okužba pljuč), zvišana telesna temperatura, reakcije, povezane z infundiranjem, in celulitis (vnetje globokega podkožnega tkiva).
The side effects seen with Poteligeo are considered manageable and most of them are mild or moderate.
Neželeni učinki, opaženi pri uporabi zdravila Poteligeo, veljajo za obvladljive, večina pa jih je blagih ali zmernih.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Poteligeo have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Poteligeo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What benefits of Poteligeo have been shown in studies?
Kakšne koristi zdravila Poteligeo so se pokazale v študijah?
Why is Poteligeo authorised in the EU?
Zakaj je bilo zdravilo Poteligeo odobreno v EU?
To reduce this risk, patients may be given other medicines such as an antipyretic (medicine that reduces fever) and an antihistamine (for treating allergic reactions) before or during treatment with Poteligeo.
Za zmanjšanje tega tveganja lahko bolniki pred ali med zdravljenjem z zdravilom Poteligeo prejmejo druga zdravila, na primer antipiretik (zdravilo za zniževanje zvišane telesne temperature) in antihistaminik (za zdravljenje alergijskih reakcij).
Side effects reported with Poteligeo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Poteligeo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It is used in patients who have received previous treatment by mouth or injection.
Uporablja se pri bolnikih, ki so že prejemali zdravila, ki se dajejo peroralno ali z injiciranjem.
What is Poteligeo and what is it used for?
Kaj je zdravilo Poteligeo in za kaj se uporablja?
Poteligeo can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the treatment of cancer and in a place where equipment for resuscitation is available in case of rare and severe allergic reaction to the medicine.
Predpisovanje in izdaja zdravila Poteligeo je le na recept, zdravljenje pa mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem raka, v okolju, kjer je na voljo oprema za oživljanje, če bi pri bolniku prišlo do redke in hude alergijske reakcije na zdravilo.
For more information about using Poteligeo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Poteligeo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
CCR4 is found on the surface of white blood cells, including the cancerous cells in mycosis fungoides or Sezary syndrome.
CCR4 se nahaja na površini belih krvnih celic, tudi rakavih celic pri bolnikih s fungoidno mikozo in Sézaryjevim sindromom.
Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Zdravilo Poteligeo vsebuje učinkovino mogamulizumab.
The most common side effects with Poteligeo (seen in more than 1 patient in 10) are infusion-related reactions and rash.
Najpogostejši neželeni učinki zdravila Poteligeo (opaženi pri več kot 1 od 10 bolnikov) so reakcije, povezane z infundiranjem, in izpuščaj.
Poteligeo is effective at prolonging the time patients with mycosis fungoides or Sezary syndrome live without their disease getting worse.
Zdravilo Poteligeo učinkovito podaljšuje čas, ki ga bolniki s fungoidno mikozo in Sézaryjevim sindromom preživijo brez poslabšanja bolezni.
By attaching to CCR4, mogamulizumab stimulates the body's immune system to attack the cancer cells, helping to control the disease.
Mogamulizumab z vezavo na CCR4 spodbudi imunski sistem, da napade rakave celice, kar pripomore k obvladovanju bolezni.
Poteligeo is a cancer medicine used to treat mycosis fungoides and Sezary syndrome - two cancers of blood cells that affect mainly the skin.
Poteligeo je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje fungoidne mikoze in Sézaryjevega sindroma - dveh vrst raka krvnih celic, ki prizadeneta predvsem kožo.
The active substance in Poteligeo, mogamulizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to a receptor (target) called CCR4.
Učinkovina v zdravilu Poteligeo, mogamulizumab, je monoklonsko protitelo (tj. vrsta beljakovine), ki je bilo zasnovano tako, da se veže na receptor (tarčo), imenovan CCR4.
Both mycosis fungoides and Sezary syndrome belong to a group of rare cancers (cutaneous T-cell lymphomas), and Poteligeo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 October 2016.
Fungoidna mikoza in Sézaryjev sindrom spadata v skupino redkih vrst raka (imenovanih kožni T-celični limfomi), zato je bilo zdravilo Poteligeo 14. oktobra 2016 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Patients should be monitored during and after the infusion for certain side effects related to the infusion.
Med infuzijo in po njej je treba bolnike nadzorovati, saj bi se pri njih lahko pojavili nekateri neželeni učinki, povezani z infundiranjem.
How is Poteligeo used?
Kako se zdravilo Poteligeo uporablja?
For the full list of side effects and restrictions with Poteligeo, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Poteligeo glejte navodilo za uporabo.
Other information about Poteligeo
Druge informacije o zdravilu Poteligeo
Poteligeo was shown to be more effective than a comparator medicine, vorinostat, in a study of 372 adults with either mycosis fungoides or Sezary syndrome.
V študiji pri 372 odraslih s fungoidno mikozo in Sézaryjevim sindromom se je pokazalo, da je zdravilo Poteligeo učinkovitejše od primerjalnega zdravila, vorinostata.
The doctor may interrupt or stop treatment, or reduce the dose, if the patient develops certain serious side effects.
Če se pri bolniku pojavijo nekateri resni neželeni učinki, bo zdravnik morda začasno ali trajno prekinil zdravljenje oziroma zmanjšal odmerek.
This may take up to 5 weeks.
To lahko traja do pet tednov.
This summary was last updated in 03-2017.
Povzetek je bil nazadnje posodobljen 03-2017.
This may help these women to become pregnant.
To lahko tem ženskam pomaga pri zanositvi.
Pergoveris must not be used in women who have:
Zdravila Pergoveris ne smejo uporabljati ženske, ki imajo:
The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris on 25 June 2007.
Evropska komisija je dovoljenje za promet z zdravilom Pergoveris, veljavno po vsej Evropski uniji, izdala 25. junija 2007.
Using less than the recommended starting dose may not be sufficient to stimulate development of a follicle.
Uporaba manjšega začetnega odmerka od priporočenega morda ne bo zadostovala za stimulacijo razvoja folikla.
What measures are being taken to ensure the safe and effective use of Pergoveris?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pergoveris?
If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Po potrebi se lahko odmerek folitropina alfa poveča z dodajanjem te učinkovine v ločenem zdravilu, pri čemer mora biti med vsakokratnim povečanjem odmerka od sedem do 14 dni premora.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Pergoveris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Pergoveris večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Pergoveris.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pergoveris.
Other information about Pergoveris
Druge informacije o zdravilu Pergoveris
The first injection must be given under direct supervision of a doctor who has experience in the treatment of fertility problems, but the patient can inject herself if she wants to, provided she has been properly trained and has access to expert advice.
Prva injekcija se daje pod neposrednim nadzorom zdravnika, ki ima izkušnje z zdravljenjem težav s plodnostjo, zdravilo pa si lahko injicira tudi bolnica sama, če je bila za to predhodno ustrezno usposobljena in ji je na voljo strokovno svetovanje.
It must also not be used in women who have malformations of the sexual organs or fibroid tumours of the womb that would stop them from becoming pregnant.
Prav tako se ne sme uporabljati pri ženskah z malformacijo spolnih organov ali fibroidnimi tumorji maternice, ki bi preprečili zanositev.
• enlarged ovaries or a cyst on the ovary that is not due to polycystic ovarian disease and is of unknown origin,
• povečanje jajčnikov ali cisto jajčnika, ki ni povezana s policistično boleznijo jajčnikov in je neznanega izvora;
The company also carried out bioequivalence studies to establish whether the combined injection produced the same levels of the active substances in the body as the two medicines given separately.
Družba je prav tako izvedla študije biološke enakovrednosti, da bi proučila, ali kombinirana injekcija ustvari enake ravni zdravilnih učinkovin v telesu kot injiciranje teh učinkovin ločeno.
The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient's response.
Priporočeni začetni odmerek je 150 mednarodnih enot (i.e.) folitropina alfa in 75 i.e. lutropina alfa enkrat na dan, ki pa ga je treba prilagoditi odzivu bolnice.
It is not intended to provide practical advice on how to use Pergoveris.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For further information see the package leaflet.
Za več informacij glejte navodilo za uporabo.
• cancer of the ovary, womb or breast.
• rak jajčnikov, maternice ali dojke.
The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection).
Najpogostejši neželeni učinki zdravila Pergoveris (opaženi pri več kot 1 bolnici od 10) so glavobol, ciste na jajčnikih in reakcije na mestu injiciranja (npr. bolečina, srbenje, rdečina, podplutba, oteklina ali vzdraženost na mestu injiciranja).
The medicine can only be obtained with a prescription.
Predpisovanje in izdaja zdravila je le na recept.
Pergoveris must not be used when a benefit cannot be obtained, such as in women with primary ovarian failure (when the ovaries stop working before the menopause).
Zdravilo Pergoveris se ne sme uporabljati, če ne more prinesti koristi, kot na primer pri ženskah s primarno odpovedjo jajčnikov (ko jajčniki prenehajo delovati pred nastopom menopavze).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pergoveris have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pergoveris upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Pergoveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pergoveris preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
EPAR summary for the public follitropin alfa / lutropin alfa
Povzetek EPAR za javnost folitropin alfa/lutropin alfa
Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems.
Zdravljenje s tem zdravilom lahko povzroči prekomerno stimulacijo jajčnikov (znano kot sindrom hiperstimulacije jajčnikov, OHSS), ki lahko povzroči resne zdravstvene težave.
What is Pergoveris and what is it used for?
Kaj je zdravilo Pergoveris in za kaj se uporablja?
• bleeding from the genital region whose cause is unknown,
• ginekološke krvavitve neznanega izvora,
Why is Pergoveris approved?
Zakaj je bilo zdravilo Pergoveris odobreno?
What benefits of Pergoveris have been shown in studies?
Kakšne koristi je zdravilo Pergoveris izkazalo v študijah?
What are the risks associated with Pergoveris?
Kakšna tveganja so povezana z zdravilom Pergoveris?
For practical information about using Pergoveris, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pergoveris naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects and restrictions with Pergoveris, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Pergoveris glejte navodilo za uporabo.
Pergoveris is injected under the skin once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels.
Zdravilo Pergoveris se injicira v podkožje enkrat na dan, dokler se pri bolnici ne razvije ustrezen folikel, kar se oceni z ultrazvočnim pregledom in merjenjem ravni estrogena v krvi.
Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris.
Obe zdravilni učinkovini sta že bili odobreni v Evropski uniji (EU), folitropin alfa kot zdravilo GONAL-f, lutropin alfa pa kot zdravilo Luveris.
The full EPAR for Pergoveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pergoveris je na voljo na spletni strani agencije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004085/human_ med_002074.jsp.
Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris.
Zato je družba v podporo zdravilu Pergoveris predstavila podatke iz študij, izvedenih v času razvoja zdravila Luveris.
• tumours of the hypothalamus or pituitary gland,
• tumor hipotalamusa ali hipofize,
Pergoveris is a fertility medicine used in women to stimulate the development of follicles, the structures inside the ovaries that contain an egg.
Pergoveris je zdravilo za zdravljenje plodnosti pri ženskah za stimulacijo razvoja foliklov, tj. mešičkov v jajčnikih, ki vsebujejo jajčece.
Pergoveris is available as a solution for injection in a pre-filled pen or as a powder and solvent to be made up into a solution for injection.
Zdravilo Pergoveris je na voljo v obliki raztopine za injiciranje v napolnjenem injekcijskem peresniku ali praška in vehikla za pripravo raztopine za injiciranje.
Pergoveris is for adult women who have low levels of two hormones that stimulate the ovariesfollicle-stimulating hormone (FSH) and luteinising hormone (LH).
Namenjeno je ženskam v odrasli dobi, ki imajo nizko raven dveh hormonov, ki stimulirata jajčnike: folikle stimulirajočega hormona (FSH) and luteinizirajočega hormona (LH).
By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG).
Zdravilo Pergoveris z nadomeščanjem manjkajočih hormonov ženskam s pomanjkanjem folikle stimulirajočega hormona in luteinizirajočega hormona omogoča nastanek folikla, iz katerega se bo po injiciranju hormona, imenovanega humani horionski gonadotropin (hCG), sprostilo jajčece.
In these studies, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles.
V teh študijah je kombinacija folitropina alfa in lutropina lafa v enakih odmerkih kot v zdravilu Pergoveris spodbudila nastanek aktivnih foliklov.
These studies confirmed that Pergoveris produced similar blood levels of follitropin alfa and lutropin alfa as when the two medicines are given separately.
Študije so potrdile, da zdravilo Pergoveris ustvari podobne ravni folitropina alfa in lutropina alfa v krvi kot dajanje teh učinkovin ločeno.
The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH.
Zdravilni učinkovini v zdravilu Pergoveris, folitropin alfa in lutropin alfa, sta kopiji naravnega folikle stimulirajočega hormona (FSH) in naravnega luteinizirajočega hormona (LH).
The medicine contains the active substances follitropin alfa and lutropin alfa.
Zdravilo vsebuje zdravilni učinkovini folitropin alfa in lutropin alfa.
Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Trombembolizem (strdki v krvnih žilah) se pojavi zelo redko, navadno pa je značilen za hudo obliko sindroma hiperstimulacije jajčnikov.
In the body, FSH stimulates the production of eggs, and LH stimulates their release.
Folikle stimulirajoči hormon v telesu spodbuja tvorbo jajčec, luteinizirajoči hormon pa spodbudi njihovo sprostitev.
How is Pergoveris used?
Kako se zdravilo Pergoveris uporablja?
Mild or moderate OHSS is common, while severe OHSS is uncommon.
Blag ali zmeren sindrom hiperstimulacije jajčnikov je pogost, huda oblika tega sindroma pa redka.
How does Pergoveris work?
Kako zdravilo Pergoveris deluje?
It is intended for short-term use.
Namenjeno je kratkotrajni uporabi.
Ref.: EMEA/644240/2009 EMEA/H/C/396
: EMEA/644240/2009 EMEA/H/C/396
After five years, the marketing authorisation was renewed for a further five years.
Po petih letih je bilo dovoljenje za promet z zdravilom podaljšano za nadaljnjih pet let.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto pregledala vse razpoložljive nove podatke in po potrebi posodobila ta povzetek.
All the studies looked at the number of patients who had died after 28 days.
V vseh študijah so beležili število bolnikov, ki so umrli po 28 dneh.
If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Xigris has been authorised under ‘Exceptional Circumstances'.
Zdravilo Xigris je bilo odobreno v „izjemnih okoliščinah“.
The recommended dose of Xigris is 24 micrograms per kilogram body weight per hour, given as a continuous infusion for 96 hours.
Priporočeni odmerek zdravila Xigris je 24 mikrogramov na kilogram telesne mase na uro, ki se daje kot neprekinjena infuzija v skupnem trajanju 96 ur.
The European Commission granted a marketing authorisation valid throughout the European Union for Xigris to Eli Lilly Nederland B.V. on 22 August 2002.
Evropska komisija je dovoljenje za promet z zdravilom Xigris, veljavno po vsej Evropski uniji, odobrila družbi Eli Lilly Nederland B.V.
It must not be used in patients below 18 years of age, in patients who have long-term liver disease, a brain tumour or pressure on the brain, in patients also receiving high-dose heparin (another medicine used to prevent blood clots) or in patients who currently have internal bleeding or are at risk of bleeding.
Ne sme se uporabljati pri bolnikih, mlajših od 18 let, pri bolnikih, ki imajo dolgotrajno obolenje jeter, možganski tumor ali pritisk v možganih, pri bolnikih, ki prejemajo heparin v visokih odmerkih (drugo zdravilo za preprečevanje krvnih strdkov), ali pri bolnikih, ki imajo notranjo krvavitev ali so v nevarnosti, da bodo krvaveli.
The toxins cause the patient's organs to fail, such as the heart, lungs and kidneys.
Toksini povzročajo odpoved organov bolnika, kot so srce, pljuča, ledvice.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xigris's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Xigris večje od z njim povezanih tveganj, in priporočil, da se za zdravilo odobri dovoljenje za promet.
For the full list of restrictions, see the Package Leaflet.
Za celoten seznam omejitev glejte navodilo za uporabo.
This means that it has not been possible to obtain complete information about Xigris.
To pomeni, da o zdravilu ni bilo mogoče pridobiti vseh informacij.
Xigris is used when the patient has two or more organs failing, in addition to best standard care such as antibiotics, medicines to support the organs and treatment in a specialised unit.
Zdravilo Xigris se uporablja, ko bolniku odpovedujeta dva organa ali več, kot dodatek najboljšemu standardnemu zdravljenju, kot so antibiotiki, zdravila za podporo organom in zdravljenje na specializiranem oddelku.
Other information about Xigris:
Druge informacije o zdravilu Xigris:
Sepsis is a condition when bacteria get into the bloodstream and produce harmful substances (toxins).
Sepsa je stanje, ko bakterije vstopijo v krvni obtok in tvorijo škodljive snovi (toksine).
Excessive blood clotting is a problem during severe sepsis, because blood clots can block the blood supply to important parts of the body such as the kidneys and lungs.
Pri hudi sepsi je težava čezmerno strjevanje krvi, ker lahko krvni strdki ovirajo oskrbo pomembnih delov telesa s krvjo, kot so ledvice in pljuča.
The company that makes Xigris will conduct an additional study looking at the safety and effectiveness of Xigris in patients with severe sepsis.
Družba, ki izdeluje zdravilo Xigris, bo opravila dodatno študijo, v kateri bo proučila varnost in učinkovitost zdravila pri bolnikih s hudo sepso.
• in the ADDRESS study, Xigris was compared with placebo in almost 3,000 patients who were at a lower risk of death than in the first two studies.
• v študiji ADRESS so zdravilo Xigris primerjali s placebom pri skoraj 3 000 bolnikih, ki so bili manj življenjsko ogroženi kot v prvih dveh študijah.
In the body, drotrecogin alfa limits how much thrombin (one of the factors involved in blood clotting) is produced, and also reduces the inflammation caused by the infection.
V telesu drotrekogin alfa omeji nastajanje trombina (enega od dejavnikov pri strjevanju krvi) ter zmanjša vnetje, ki ga povzroča okužba.
• in the ENHANCE study, over 2,000 patients received Xigris;
• v študiji ENHANCE je zdravilo Xigris prejelo več kot 2 000 bolnikov;
The active substance in Xigris, drotrecogin alfa (activated), is very similar to a natural anticoagulant found in the body called activated protein C. Drotrecogin alfa is 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 drotrecogin alfa.
Zdravilna učinkovina zdravila Xigris, drotrekogin alfa (aktiviran), je zelo podobna naravnemu antikoagulacijskemu sredstvu v telesu, ki se imenuje aktiviran protein C. Drotrekogin alfa je izdelan z metodo, znano kot „tehnologija rekombinantne DNK“.
It contains the active substance drotrecogin alfa (activated).
Vsebuje zdravilno učinkovino drotrekogin alfa (aktiviran).