natgillin/translations-raw huggingface dataset:
If the Vidaza suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours.
Če suspenzijo zdravila Vidaza pripravite z vodo za injekcije, ki ni bila v hladilniku, morate dati suspenzijo takoj po pripravi v hladilnik (2 °C - 8 °C), kjer sme biti shranjena največ 8 ur.
HR = hazard ratio
Število ogroženih CCR azacitidin
Posology
Izdelovalec
What is in this leaflet:
Kaj vsebuje navodilo
What Vidaza is
Kaj je zdravilo Vidaza
OTHER
Občasni
Very common Common
Organski sistem Zelo pogosti
• Bruising.
• srbenje
One case of overdose with azacitidine was reported during clinical trials.
Med kliničnimi preskušanji so poročali o enem primeru prevelikega odmerjanja azacitidina.
• Being short of breath when you move.
• kratka sapa med gibanjem
• Shivering (chills).
• drgetanje (mrzlica)
How to store Vidaza
Zdravljenje azacitidin
• Weight loss.
• Zvišana telesna temperatura.
Common side effects (may affect up to 1 in 10 people)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
• Rash.
• modrice
• Liver failure.
• odpoved jeter
• Muscle spasms.
• suh kašelj
In some cases these reactions can become severe.
V nekaterih primerih lahko te reakcije postanejo resne.
Further information can be found in the summary of the risk management plan.
Dodatne informacije so na voljo v povzetku načrta obvladovanja tveganj.
The injection is given into a vein over several minutes.
Injekcija se daje v veno nekaj minut.
Comparable results were seen in patients who continued to take the medicine after completion of the initial study.
Primerljive rezultate so opazili pri bolnikih, ki so po koncu začetne študije še naprej jemali zdravilo.
What measures are being taken to ensure the safe and effective use of Iblias?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Iblias?
Other information about Iblias
Druge informacije o zdravilu Iblias
Response to treatment was considered good or excellent in about 90% of cases.
Odziv na zdravljenje je bil v 90 % primerih ocenjen kot dober ali odličen.
The full EPAR and risk management plan summary for Iblias 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) in povzetek načrta obvladovanja tveganj za zdravilo Iblias sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Pojasnjuje, kako je agencija ocenila to zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
Regarding safety, the reported effects are in line with those expected for a factor VIII product.
Kar zadeva varnost, so učinki, o katerih so poročali, v skladu s pričakovanimi učinki pri zdravilu s faktorjem VIII.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Iblias'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 Iblias 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 Iblias.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Iblias.
A risk management plan has been developed to ensure that Iblias is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Iblias je bil pripravljen načrt za obvladovanje tveganja.
Data from a supportive study also confirmed the benefits of preventative treatment with Iblias in reducing the number of bleeds.
Tudi podatki podporne študije so potrdili koristi preventivnega zdravljenja z zdravilom Iblias pri zmanjševanju števila krvavitev.
For further information, see the summary of product characteristics (also part of the EPAR).
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing.
Če se pojavijo, lahko vključujejo angioedem (otekanje podkožnega tkiva), pekoč občutek in zbadanje na mestu injiciranja, mrzlico, rdečico, srbeč izpuščaj po vsem telesu, glavobol, koprivnico, hipotenzijo (nizek krvni tlak), letargijo, navzeo (slabost), nemir, tahikardijo (pospešen srčni utrip), tiščanje v prsnem košu, mravljinčenje, bruhanje in sopenje.
It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.
Nadomešča manjkajoči faktor VIII ter tako pripomore k strjevanju krvi in omogoči začasen nadzor nad krvavitvijo.
In 12 patients who required major surgery during the study, control of blood loss was also rated as good or excellent by the patients' doctors.
Tudi pri 12 bolnikih, ki so med študijo potrebovali večji kirurški poseg, so njihovi zdravniki ocenili, da je bil nadzor nad izgubo krvi dober ali odličen.
It contains the active substance octocog alfa, which is the same as human factor VIII.
Vsebuje zdravilno učinkovino oktokog alfa, ki je enaka humanemu faktorju VIII.
What is Iblias and what is it used for?
Kaj je zdravilo Iblias in za kaj se uporablja?
Why is Iblias approved?
Zakaj je bilo zdravilo Iblias odobreno?
It is not intended to provide practical advice on how to use Iblias.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Iblias has been shown to be effective in both preventing and treating bleeds, including managing blood loss during surgery, and can be used in all age groups.
Dokazali so, da je zdravilo Iblias učinkovito pri preprečevanju in zdravljenju krvavite, vključno z obvladovanjem izgube krvi med kirurškimi posegi, in se lahko uporablja pri vseh starostnih skupinah.
The dose and frequency of the injections depend on whether Iblias is used to treat or prevent bleeding, the severity of the patient's factor VIII deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo Iblias uporablja za zdravljenje ali preprečevanje krvavitve, resnosti bolnikovega pomanjkanja faktorja VIII, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
What benefits of Iblias have been shown in studies?
Kakšne koristi je zdravilo Iblias izkazalo v študijah?
What are the risks associated with Iblias?
Kakšna so tveganja, povezana z zdravilom Iblias?
Patients may develop antibodies to hamster or mouse proteins; the medicine must not be used in patients who are hypersensitive (allergic) to octocog alfa or to hamster or mouse proteins.
Bolniki lahko tvorijo protitelesa proti beljakovinam hrčka ali miši; zdravilo se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) oktokog alfa ali beljakovine hrčka ali miši.
This compared with an average of 6.9 bleeds per year before Iblias treatment.
To povprečje je pred zdravljenjem z zdravilom Iblias znašalo 6,9 krvavitve na leto.
A second study involved 51 children under 12 years of age previously treated with other factor VIII products, who also had 3.8 bleeds per year on average during treatment with Iblias (mostly related to injuries).
Druga študija je vključevala 51 otrok, mlajših od 12 let, ki so se predhodno zdravili z drugimi zdravili s faktorjem VIII in so med zdravljenjem z zdravilom Iblias prav tako doživeli 3,8 krvavitve na leto (večinoma v povezavi s poškodbami).
Iblias can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Izdaja zdravila Iblias je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika z izkušnjami z zdravljenjem hemofilije.
There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Pri zdravilih s faktorjem VIII obstaja tudi tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvijo.
Iblias is available as a powder and solvent used to make a solution for injection.
Zdravilo Iblias je na voljo kot prašek in vehikel za pripravo raztopine za injiciranje.
The effectiveness of Iblias in preventing and treating bleeding has been shown in a main study involving 62 patients aged 12 years or older with severe haemophilia A who were previously treated with other factor VIII products.
Učinkovitost zdravila Iblias pri preprečevanju in zdravljenju krvavitev so dokazali v glavni študiji, ki je vključevala 62 bolnikov, starejših od 12 let, s hudo obliko hemofilije A, ki so se predhodno zdravili z drugimi zdravili s faktorjem VIII.
The active substance in Iblias, octocog alfa, works in the body in the same way as human factor VIII.
Zdravilna učinkovina zdravila Iblias, efmoroktokog alfa, deluje v telesu enako kot humani faktor VIII.
Iblias is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Iblias je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor VIII).
Hypersensitivity (allergic) reactions are uncommon with Iblias, affecting from 1 patient in 1,000 to less than 1 patient in 100.
Občasno so pri zdravilu Iblias opazili preobčutljivostne (alergijske) reakcije, ki prizadenejo med 1 osebo od 1 000 in manj kot 1 osebo od 100.
In addition, the company that markets Iblias will complete studies to investigate the safety and efficacy of the medicine in patients who have not previously been treated with other factor VIII products, and to provide further evidence of the safety and efficacy of long-term treatment with Iblias in children.
Poleg tega bo podjetje, ki trži zdravilo Iblias, izvedlo študije, s katerimi bodo proučili varnost in učinkovitost zdravila pri bolnikih, ki se predhodno niso zdravili z drugimi zdravili s faktorjem VIII, in zagotovili dodatne dokaze o varnosti in učinkovitosti dolgotrajnega zdravljenja z zdravilom Iblias pri otrocih.
For the full list of all side effects and restrictions with Iblias, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Iblias glejte navodilo za uporabo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iblias, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems such as bleeding into the joints, muscles and internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, tj. beljakovine, ki je potrebna za normalno strjevanje krvi, zato hitreje zakrvavijo in imajo lahko težave, kot so krvavitve v sklepe, mišice in notranje organe.
For more information about treatment with Iblias, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Iblias preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Iblias, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Iblias naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
About 70% of the bleeding events that occurred were managed with a single injection of Iblias, and about another 15% responded to a second injection; the response was considered good or excellent in around 80% of cases.
Približno 70 % krvavitev, ki so se pojavile, so obvladali z enkratno injekcijo zdravila Iblias , naslednjih 15 % pa se je odzvalo na drugo injekcijo.
The number of bleeds that occurred during Iblias treatment was calculated as 3.8 bleeds per year on average (mostly into joints).
Število krvavitev med zdravljenjem z zdravilom Iblias so z izračunom pretvorili v povprečno 3,8 krvavitve na leto (večinoma v sklepe).
Further evidence of effectiveness and safety in patients previously untreated with factor VIII medicines, and further data on long-term use in children should be provided by ongoing studies.
Potekajoče študije bodo morale prinesti dodatne dokaze o učinkovitosti in varnosti pri bolnikih, ki se predhodno niso zdravili z zdravili s faktorjem VIII, in nadaljnje podatke o dolgoročni uporabi pri otrocih.
How does Iblias work?
Kako zdravilo Iblias deluje?
How is Iblias used?
Kako se zdravilo Iblias uporablja?
This overview was last updated in 12-2019.
Povzetek je bil nazadnje posodobljen 12-2019.
In addition, the safety of the medicine was considered acceptable.
Poleg tega je bila varnost zdravila ocenjena kot sprejemljiva.
Further information on Zydelig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zydelig.
Nadaljnje informacije za zdravilo Zydelig so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zydelig.
Zydelig received a marketing authorisation valid throughout the EU on 18 September 2014.
Za zdravilo Zydelig je bilo 18. septembra 2014 izdano dovoljenje za promet, veljavno po vsej EU.
The Agency therefore concluded that Zydelig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Agencija je zato zaključila, da so koristi zdravila Zydelig večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Zydelig?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zydelig?
Other information about Zydelig
Druge informacije o zdravilu Zydelig
If the patient has severe side effects, treatment must be stopped and can be restarted at a lower dose of 100 mg twice a day.
Če se pri bolniku pojavijo resni neželeni učinki, je treba zdravljenje prekiniti in ponovno začeti z manjšim odmerkom 100 mg dvakrat na dan.
Why is Zydelig authorised in the EU?
Zakaj je zdravilo Zydelig odobreno v EU?
Patients should also be monitored for infection and have regular blood tests to measure the level of white blood cells.
Poleg tega je treba bolnike spremljati zaradi okužbe in pri njih redno opravljati krvne preiskave za merjenje števila belih krvnih celic.
Zydelig is available as 100 mg and 150 mg tablets.
Zdravilo Zydelig je na voljo v obliki 100- in 150-miligramskih tablet.
As for all medicines, data on the use of Zydelig are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zydelig stalno spremljajo.
What is Zydelig and what is it used for?
Kaj je zdravilo Zydelig in za kaj se uporablja?
The recommended dose is 150 mg twice a day, and treatment should be continued for as long as the patient improves or remains stable and the side effects are tolerable.
Priporočeni odmerek je 150 mg dvakrat na dan, zdravljenje pa se mora nadaljevati, dokler se bolnikovo stanje izboljšuje ali ostaja stabilno, neželeni učinki pa so znosni.
What benefits of Zydelig have been shown in studies?
Kakšne koristi zdravila Zydelig so se pokazale v študijah?
An overview of Zydelig and why it is authorised in the EU
Pregled zdravila Zydelig in zakaj je odobreno v EU
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zydelig 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 Zydelig upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
This enzyme plays a role in the growth, migration and survival of white blood cells but is overactive in blood cancers, where it enables the survival of the cancer cells.
Ta encim sodeluje pri rasti, migraciji in preživetju belih krvnih celic, vendar je preveč dejaven pri krvnem raku, kjer omogoča preživetje rakavih celic.
Side effects reported with Zydelig are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Zydelig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Zydelig?
Kakšna tveganja so povezana z zdravilom Zydelig?
Zydelig should not be started in patients with any generalised infection (infection that has spread with symptoms affecting the whole body, such as fever and chills).
Zdravilo Zydelig se ne sme uporabljati pri bolnikih s kakršno koli generalizirano okužbo (okužbo, ki se je razširila, s simptomi, ki vplivajo na celotno telo, kot so povišana telesna temperatura in mrzlica).
The European Medicines Agency noted that data from the main studies showed high response rates with Zydelig in patients with chronic lymphocytic leukaemia and follicular lymphoma.
Evropska agencija za zdravila je ugotovila, da so podatki iz glavnih študij pokazali visoke stopnje odziva na zdravilo Zydelig pri bolnikih s kronično limfocitno levkemijo in folikularnim limfomom.
For more information about using Zydelig, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Zydelig glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Zydelig can only be obtained with a prescription and it should be prescribed by a doctor experienced in using cancer medicines.
Predpisovanje in izdaja zdravila Zydelig je le na recept, zdravljenje z njim pa mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
By targeting this enzyme and blocking its effects, idelalisib causes death of the cancer cells, thereby delaying or stopping the progression of the cancer.
Idelalisib z delovanjem na ta encim in zaviranjem njegovih učinkov povzroči odmrtje rakavih celic, s čimer se upočasni ali zaustavi napredovanje raka.
Zydelig was effective, with 54% of patients with follicular lymphoma having either a complete or partial response to treatment.
Zdravilo Zydelig je bilo učinkovito, saj je pri 54 % bolnikov s folikularnim limfomom prišlo bodisi do popolnega bodisi delnega odziva na zdravljenje.
The active substance in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta.
Učinkovina v zdravilu Zydelig, idelalisib, zavira učinke encima, imenovanega PI3K-delta.
Zydelig was also more effective than placebo in patients who had a specific genetic mutation in their cancer cells that makes them unsuitable for certain other therapies.
Zdravilo Zydelig je bilo učinkovitejše od placeba tudi pri bolnikih, ki so imeli posebno gensko mutacijo v rakavih celicah, zaradi česar niso primerni za nekatere druge vrste zdravljenj.
The most common side effects with Zydelig (which may affect more than 1 in 10 people) are infections (including lung infection caused by Pneumocystis jirovecii, and cytomegalovirus infections), neutropenia (low levels of neutrophils, a type of white blood cell), lymphocytosis (increased levels of lymphocytes, another type of white blood cell), diarrhoea, blood tests showing changes in the liver, rash, fever and increased blood fat levels.
Najpogostejši neželeni učinki zdravila Zydelig (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužbe (vključno z okužbo pljuč, ki jo povzroča bakterija Pneumocystis jirovecii, in okužbe s citomegalovirusi), nevtropenija (nizke ravni nevtrofilcev, tj. vrste belih krvnih celic), limfocitoza (povečane ravni limfocitov, tj. druge vrste belih krvnih celic), driska, rezultati krvnih preiskav, ki kažejo spremembe na jetrih, izpuščaj, povišana telesna temperatura in povišane ravni maščob v krvi.
For the full list of side effects and restrictions of Zydelig, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zydelig glejte navodilo za uporabo.
How is Zydelig used?
Kako se zdravilo Zydelig uporablja?
In a main study of 220 patients with previously treated CLL, Zydelig was more effective at treating the cancer than placebo (a dummy treatment) when both were given in combination with rituximab: 75% of patients taking Zydelig had an improvement in their disease compared with 15% of patients receiving placebo.
V glavni študiji pri 220 bolnikih s predhodno zdravljeno kronično limfocitno levkemijo je bilo zdravilo Zydelig učinkovitejše pri zdravljenju raka kot placebo (zdravilo brez učinkovine), pri čemer sta bila oba dana v kombinaciji z rituksimabom: do izboljšanja bolezenskega stanja je prišlo pri 75 % bolnikov, ki so prejemali zdravilo Zydelig, v primerjavi s 15 % bolnikov, ki so prejemali placebo.
In a study of 261 previously treated CLL patients, it took over 16 months on average before the disease got worse in patients treated with Zydelig plus ofatumumab, compared with 8 months in those treated with ofatumumab alone.
V študiji, v kateri je sodelovalo 261 predhodno zdravljenih bolnikov s kronično limfocitno levkemijo, se je bolezen v povprečju poslabšala po več kot 16 mesecih v primerjavi z 8 meseci pri bolnikih, ki so jih zdravili samo z ofatumumabom.
In follicular lymphoma, Zydelig is used on its own in patients whose disease has not improved with two previous treatments.
Pri folikularnem limfomu se zdravilo Zydelig uporablja kot samostojno zdravilo pri bolnikih, katerih bolezen se po dveh predhodnih zdravljenjih ni izboljšala.
Another main study evaluated Zydelig in patients with different lymphomas, including 72 patients with follicular lymphoma that had failed two previous treatments.
V drugi glavni študiji so proučevali zdravilo Zydelig pri bolnikih z različnimi limfomi, vključno z 72 bolniki s folikularnim limfomom, pri katerih sta bili dve predhodni zdravljenji neuspešni.
Zydelig was also effective in chronic lymphocytic leukaemia patients whose cancer cells have the 17p deletion or TP53 mutation, who usually have a poor outcome.
Zdravilo Zydelig je bilo učinkovito tudi pri bolnikih s kronično limfocitno levkemijo, katerih rakave celice imajo delecijo 17p ali mutacijo TP53, pri katerih je izid zdravljenja običajno slab.
Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
Zydelig je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje kronične limfocitne levkemije (KLL, raka vrste belih krvnih celic, imenovanih limfociti B) in folikularnega limfoma (druge vrste raka, ki prizadene limfocite B).
In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients whose cancer cells have genetic mutations (changes) called 17p deletion or TP53 mutation and who cannot be treated with any other therapy.
Pri kronični limfocitni levkemiji se zdravilo Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimabom ali ofatumumabom) pri bolnikih, ki so prejemali vsaj eno predhodno zdravljenje, in pri bolnikih, ki imajo v rakavih celicah genske mutacije (spremembe), imenovane delecija 17p ali mutacija TP53, in katerih ni mogoče zdraviti z nobenim drugim zdravljenjem.
How does Zydelig work?
Kako zdravilo Zydelig deluje?