natgillin/translations-raw huggingface dataset:
The full EPAR for Ibrance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Ibrance nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In both studies, the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
U oba ispitivanja, glavna mjera djelotvornosti bila je dužina života bolesnica bez pogoršanja bolesti (preživljenje bez napredovanja bolesti).
The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle.
Preporučena doza je 125 mg jednom dnevno uzastopno tijekom 21 dana, a nakon toga slijedi 7 dana bez terapije čime je dovršen ciklus liječenja od 28 dana.
Regarding safety, the main risk is neutropenia, which is a well-known risk of many cancer medicines and is considered manageable.
S obzirom na sigurnost, glavni rizik je neutropenija, a to je dobro poznati rizik kod primjene mnogih lijekova protiv raka i smatra se da ga se može kontrolirati.
What measures are being taken to ensure the safe and effective use of Ibrance?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ibrance?
What is Ibrance and what is it used for?
Što je Ibrance i za što se koristi?
If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.
Ako bolesnica osjeti neke nuspojave, terapiju će možda trebati privremeno prekinuti ili zaustaviti ili smanjiti dozu.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje za stavljanje u promet u EU-u te uvjete za njegovu primjenu.
Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable.
Liječenje treba nastaviti sve dok bolesnica ima koristi od liječenja, a nuspojave su podnošljive.
Why is Ibrance approved?
Zašto je Ibrance odobren?
Ibrance palbociclib
Ibrance palbociklib
In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
U žena koje još nisu u menopauzi, potrebno je davati i lijek koji se naziva agonist hormona koji oslobađa luteinizirajući hormon.
• together with an aromatase inhibitor (a hormonal medicine for cancer);
• u kombinaciji s inhibitorom aromataze (hormonskim lijekom protiv raka);
Other information about Ibrance
Ostale informacije o lijeku Ibrance
Ibrance is a cancer medicine used to treat locally advanced or metastatic breast cancer (cancer that has begun to spread to other parts of the body).
Ibrance je lijek protiv raka, a primjenjuje se za liječenje lokalno uznapredovalog ili metastatskog raka dojke (raka koji se počeo širiti na druge dijelove tijela).
This is a summary of the European public assessment report (EPAR) for Ibrance.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Ibrance.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Ibrance's benefits are greater than its risks and recommended that it be approved for use in the EU.
Stoga je Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio da koristi od lijeka Ibrance nadmašuju s njime povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
Ibrance can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER [human epidermal growth factor] negative).
Ibrance se može primjenjivati samo onda kada stanice raka na svojoj površini imaju receptore za određene hormone (HR pozitivne) i ne proizvode abnormalno velike količine receptora pod nazivom HER2 (HER [humani epidermalni faktor rasta] negativni).
The first study involved 521 women with metastatic breast cancer that had got worse after treatment with a hormonal medicine.
Prvo ispitivanje uključivalo je 521 ženu s metastatskim rakom dojke koji se pogoršao nakon liječenja hormonskim lijekom.
Ibrance can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Ibrance se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik iskusan u primjeni lijekova protiv raka.
They received either Ibrance and letrozole (an aromatase inhibitor) or placebo and letrozole.
Primale su ili Ibrance i letrozol (inhibitor aromataze) ili placebo i letrozol.
The second study involved 666 women who had been through the menopause and whose breast cancer had started to spread and who had not yet received cancer treatment.
Drugo ispitivanje uključivalo je 666 žena koje su prošle menopauzu i u kojih se rak dojke počeo širiti, a još nisu primale terapiju protiv raka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ibrance have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ibrance nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
The most common side effects with Ibrance (which may affect more than 1 in 5 people) are neutropenia (low blood levels of neutrophils, a type of white blood cell that fights infection), infections, leucopenia (low white blood cell counts), tiredness, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), anaemia (low red blood cell counts), alopecia (hair loss) and diarrhoea.
Najčešće nuspojave lijeka Ibrance (koje se mogu javiti u više od 1 na 5 osoba) jesu neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica koje suzbijaju infekciju), infekcije, leukopenija (mali broj bijelih krvnih stanica), umor, mučnina, stomatitis (upala sluznice usta), anemija (mali broj crvenih krvnih stanica), alopecija (gubitak kose) i proljev.
The active substance in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Djelatna tvar u lijeku Ibrance, palbociklib, blokira aktivnost enzima poznatih kao kinaze ovisne o ciklinima (CDK) 4 i 6, koje imaju ključnu ulogu u regulaciji načina na koji stanice rastu i dijele se.
It is not intended to provide practical advice on how to use Ibrance.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Ibrance.
By blocking CDK4 and CDK6, Ibrance slows the growth of HRpositive breast cancer cells.
Blokiranjem CDK4 i CDK6, Ibrance usporava rast HR pozitivnih stanica raka dojke.
The most common severe side effects with Ibrance (which may affect up to 1 in 50 people) are neutropenia, leucopenia, anaemia, tiredness and infections.
Najčešće teške nuspojave lijeka Ibrance (mogu se javiti u do 1 na 50 osoba) jesu neutropenija, leukopenija, anemija, umor i infekcije.
What are the risks associated with Ibrance?
Koji su rizici povezani s lijekom Ibrance?
Ibrance has been shown to prolong the time patients live without their disease getting worse by an average of 6 to 10 months, which is considered of clear clinical value.
Pokazalo se da Ibrance produljuje vrijeme koje bolesnice prožive bez pogoršanja bolesti za prosječno 6 do 10 mjeseci, što se smatra izravnim pokazateljem kliničke vrijednosti.
• together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
• u kombinaciji s fulvestrantom (drugim hormonskim lijekom protiv raka) u bolesnica koje su prethodno liječene hormonskim lijekovima.
For more information about treatment with Ibrance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Ibrance pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Ibrance has been studied in two main studies of women with HR-positive, HER2-negative breast cancer.
Ibrance je ispitivan u dva glavna ispitivanja u žena s HR pozitivnim i HER2 negativnim rakom dojke.
In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably.
U nekih tipova raka, uključujući HR pozitivni rak dojke, aktivnost CDK-a 4 i 6 povećana je, što pomaže stanicama raka da se nekontrolirano umnažaju.
Women taking Ibrance and letrozole lived on average 24.8 months without their disease getting worse compared with 14.5 months for women taking placebo and letrozole.
Žene koje su uzimale Ibrance i letrozol živjele su u prosjeku 24,8 mjeseci bez pogoršanja bolesti, u usporedbi s 14,5 mjeseci za žene koje su uzimale placebo i letrozol.
Ibrance contains the active substance palbociclib.
Ibrance sadrži djelatnu tvar palbociklib.
Women taking Ibrance and fulvestrant lived on average 11.2 months without their disease getting worse compared with 4.6 months for women taking placebo and fulvestrant.
Žene koje su uzimale Ibrance i fulvestrant živjele su u prosjeku 11,2 mjeseca bez pogoršanja bolesti, u usporedbi s 4,6 mjeseci za žene koje su uzimale placebo i fulvestrant.
Ibrance must not be used by patients who are taking St John's wort (a herbal preparation used to treat depression).
Ibrance ne smiju primjenjivati bolesnice koje uzimaju gospinu travu (biljni pripravak za liječenje depresije).
For practical information about using Ibrance, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Ibrance bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
What benefits of Ibrance have been shown in studies?
Koje su koristi lijeka Ibrance utvrđene u ispitivanjima?
How does Ibrance work?
Kako djeluje Ibrance?
How is Ibrance used?
Kako se Ibrance koristi?
For the full list of all side effects reported with Ibrance, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ibrance potražite u uputi o lijeku.
--1 Live attenuated Muscovy duck parvovirus ≥ 2.6 log10 CCID50 * * Cell culture infectious dose 50%
--1 Živi atenuirani parvovirus mošusne patke ≥2,6-4,8 log10 CCDI50* * Infektivne doza 50% kultura stanica
10 bags + 10 trocars
10 vrećica + 10 troakara
Packaging Content Package size
Sastav Veličina pakovanja
Muscovy ducks
Mošusne patke
1 bag + 1 trocar
1 vrećica + 1 troakar
Invented name
EU broj odobrenja Izmišljeno ime
Suspension and diluent for suspension for injection
EU/2/14/162/001 Parvoduk _ _1 Suspenzija i otapalo za suspenziju za injekciju
1 vial
Mošusne
Route of administration
Put primjene Pakovanje
The full EPAR for Relistor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This summary was last updated in 12-2016.
Ovaj sažetak je posljednji put ažuriran: 12. 2016.
The percentages of successful injections for the two groups were around 30% and 9%, respectively.
Postotak uspješnih injekcija za te dvije grupe bio je otprilike 30 % odnosno 9 %.
The dose depends on the patient's body weight.
Doza lijeka ovisi o tjelesnoj težini bolesnika.
These side effects are generally mild or moderate.
Te su nuspojave većinom blage ili umjerene.
The European Commission granted a marketing authorisation valid throughout the European Union for Relistor on 2 July 2008.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Relistor na snazi u Europskoj uniji od 2. srpnja 2008.
This is a summary of the European public assessment report (EPAR) for Relistor.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Relistor.
Other information about Relistor
Ostale informacije o lijeku Relistor
These receptors are also found in the gut.
Isti se receptori nalaze i u crijevima.
What measures are being taken to ensure the safe and effective use of Relistor?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Relistor?
The Agency's Committee for Medicinal Products for Human Use decided that Relistor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka Relistor nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
What is Relistor and what is it used for?
Što je Relistor i za što se koristi?
Relistor is used to treat constipation caused by opioid painkillers (such as morphine) when laxative medicines have not worked well enough.
Relistor se koristi za liječenje zatvora uzrokovanog opioidnim analgeticima (poput morfija) kada se laksativi nisu pokazali dovoljno dobrima.
Relistor has also been compared with placebo in a third study involving 496 patients with constipation caused by opioids, but no advanced illness.
Relistor je također uspoređen s placebom u trećem ispitivanju koje je obuhvatilo 496 bolesnika sa zatvorom uzrokovanim opioidima, no bez uznapredovale bolesti.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relistor have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Relistor nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Why is Relistor approved?
Zašto je Relistor odobren?
Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique).
Relistor se ne preporučuje za bolesnike koji imaju vrlo ozbiljne probleme s bubrezima koji zahtijevaju dijalizu (tehnika čišćenja krvi).
The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal pain (stomach ache), nausea (feeling sick), diarrhoea and flatulence.
Najčešće nuspojave lijeka Relistor (uočene kod više od 1 na 10 bolesnika) su abdominalna bol (bol u trbuhu), mučnina, proljev i vjetrovi.
This means that it blocks a specific type of opioid receptor called the ‘mu-opioid receptor'.
To znači da inhibira određeni tip opioidnih receptora naziva „mu-opioidni receptor”.
It is not intended to provide practical advice on how to use Relistor.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Relistor.
Relistor methylnaltrexone bromide
Relistor metilnaltreksonbromid
Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids.
Relistor se pokazao djelotvornijim od placeba (prividnog liječenja) u poticanju pražnjenja crijeva u dvama glavnim ispitivanjima koja su obuhvatila ukupno 288 bolesnika s uznapredovalom bolesti i zatvorom uzrokovanim opioidima.
In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines.
U bolesnika koji primaju palijativnu skrb (terapiju simptoma ozbiljne bolesti čija namjena nije izlječenje), Relistor se primjenjuje kao potkožna injekcija jednom svaka dva dana, kao dodatak uobičajenim laksativima.
In patients not on palliative care, Relistor is given as an injection under the skin at a dose of 12 mg once a day, for at least 4 days per week and up to 7 days per week as needed; treatment with usual laxatives should be stopped when starting Relistor.
U bolesnika koji ne primaju palijativnu skrb, Relistor se primjenjuje kao potkožna injekcija u dozi od 12 mg jednom na dan najmanje 4 dana tjedno a, prema potrebi, do 7 dana tjedno; kad započne terapija lijekom Relistor, liječenje uobičajenim laksativima treba prekinuti.
For more information about treatment with Relistor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Relistor pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Relistor can only be obtained with a prescription.
Relistor se izdaje samo na recept.
It is available as a solution for injection in vials or in prefilled syringes.
Dostupan je kao otopina za injekciju u bočicama ili napunjenim štrcaljkama.
Methylnaltrexone bromide is less able to enter the brain than naltrexone, meaning that it blocks the mu-opioid receptors in the gut but not in the brain.
Metilnaltreksonbromid ima manju mogućnost prodiranja u mozak od naltreksona, što znači da inhibira mu-opioidne receptore u crijevima, no ne i u mozgu.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Metilnaltreksonbromid se dobiva iz naltreksona, dobro poznate tvari koja se koristi za inhibiranje djelovanja opioida.
What are the risks associated with Relistor?
Koji su rizici povezani s lijekom Relistor?
Relistor must not be used in patients whose bowel is blocked, who are at risk of recurrent bowel blockage or who have a condition that needs immediate bowel surgery.
Relistor se ne smije koristiti u bolesnika čija su crijeva začepljena, u kojih postoji opasnost od uzastopnog začepljenja ili čije stanje zahtijeva neodgodiv kirurški zahvat na crijevima.
By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects.
Inhibirajući te receptore Relistor smanjuje zatvor uzrokovan opioidima, no ne interferira s njihovim analgetičkim djelovanjem.
Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Opioidi ublažavaju bol vezujući se na „opioidne receptore” u mozgu i leđnoj moždini.
The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'.
Djelatna tvar lijeka Relistor, metilnatreksonbromid, antagonist je „mu-opioidnih receptora”.
For practical information about using Relistor, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Relistor bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
When opioids attach to the gut receptors, the mobility of the gut is reduced, leading to constipation.
Kada se opioidi vezuju na receptore u crijevima, mobilnost crijeva se smanjuje, što rezultira zatvorom.
The main measure of effectiveness in both studies was the number of patients who had a bowel movement within four hours of the first dose.
Glavna mjera djelotvornosti u oba ispitivanja bio je broj bolesnika u kojih je došlo do pražnjenja crijeva unutar četiri sata od uzimanja prve doze.
In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
U drugom ispitivanju, 52 % bolesnika koji su primali lijek Relistor imalo je pražnjenje crijeva najmanje dva puta u roku od četiri sata od uzimanja prve četiri doze (32 od 62), u usporedbi s 8 % onih koji su primali placebo (6 od 71).
Relistor contains the active substance methylnaltrexone bromide.
Relistor sadrži djelatnu tvar metilnaltreksonbromid.
Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Promatrajući rezultate oba ispitivanja zajedno, u 55 % bolesnika koji su primali lijek Relistor do pražnjenja crijeva došlo je unutar četiri sata nakon prve injekcije (91 od 165), u usporedbi s 15 % bolesnika koji su primali placebo (18 od 123).
The main measures of effectiveness were the number of patients who had a bowel movement within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement.
Glavne mjere djelotvornosti bile su broj bolesnika u kojih je došlo do pražnjenja crijeva unutar četiri sata od prve doze i postotak injekcija koje su dovele do pražnjenja crijeva.
How does Relistor work?
Kako djeluje Relistor?
The second study also looked at the number of patients who had a bowel movement at least twice within four hours of the first four doses.
Drugo je ispitivanje istražilo broj bolesnika koji su imali pražnjenje crijeva najmanje dva puta unutar četiri sata od uzimanja prve četiri doze.
What benefits of Relistor have been shown in studies?
Koje su koristi lijeka Relistor utvrđene u ispitivanjima?
Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162).
Rezultati su pokazali da je do pražnjenja crijeva unutar četiri sata nakon prve injekcije došlo u 34 % bolesnika (102 od 298) koji su primali lijek Relistor, u usporedbi s 10 % onih koji su primali placebo (16 od 162).
Patients can inject Relistor themselves once they have been trained appropriately.
Ako prođu odgovarajuću obuku, bolesnici si mogu samostalno injicirati lijek Relistor.
Relistor is usually injected under the skin of the upper legs, belly or upper arms.
Potkožna injekcija lijeka Relistor obično se daje u bedro, trbuh ili nadlakticu.
For the full list of all side effects reported with Relistor, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Relistor potražite u uputi o lijeku.
How is Relistor used?
Kako se Relistor koristi?
The dose of Relistor should be reduced in patients who have severe kidney problems.
U bolesnika koji imaju ozbiljne probleme s bubrezima dozu lijeka Relistor treba smanjiti.
- Allow the area to dry for 15 minutes.
- Pustite da se to područje suši 15 minuta.
No overall differences in safety or efficacy were observed between younger and older patients.
Nisu primijećene ukupne razlike u sigurnosti ili djelotvornosti između mlađih i starijih bolesnika.
Instructions for use: - Open a new tube each time you use this medicine.
Upute za uporabu: - Otvorite novu tubu svaki put kad upotrebljavate ovaj lijek.
This leaflet was last revised in.
Ova uputa je zadnji puta revidirana u.
Wash the area with soap and water.
Operite područje sapunom i vodom.
For single use only.
Samo za jednokratnu upotrebu.
to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
<1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
- Do not apply more gel than your doctor has advised.
- Ne upotrebljavajte više gela nego što Vam je savjetovao liječnik.
8 weeks after randomisation
8 tjedana nakon randomizacije
The tube is for single use only and should be discarded after use (see section 6.6).
Tuba je namijenjena samo za jednokratnu upotrebu i treba se baciti nakon upotrebe (vidjeti dio 6.6).
The level of efficacy varied between the individual anatomical locations.
Razina djelotvornosti razlikovala se između pojedinih anatomskih lokacija.
The study should be based on an agreed protocol.
Ispitivanje se treba temeljiti na dogovorenom planu ispitivanja.
Tubes should be discarded after first opening.
Tube je potrebno zbrinuti nakon prvog otvaranja.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego što počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
gel 2 tubes
gel 2 tube
Do not apply Picato on open-wounds or damaged skin.
Nemojte nanositi Picato na otvorene rane ili oštećenu kožu.
What Picato is and what it is used for
Što je Picato i za što se koristi
Experience with more than one treatment course
Iskustvo s više od jednog ciklusa liječenja