natgillin/translations-raw huggingface dataset:
How often the treatment is repeated depends on which disease is being treated, and on the patient's response to the medicine.
Kako pogosto je treba zdravljenje ponavljati, je odvisno od vrste zdravljene bolezni in bolnikovega odziva na zdravilo.
The European Commission granted a marketing authorisation valid throughout the European Union for Inflectra on 10 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Inflectra, veljavno po vsej Evropski uniji, odobrila dne 10. septembra 2013.
This means that Inflectra is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Inflectra and the reference medicine contain the same active substance.
To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU), in vsebuje isto zdravilno učinkovino kot referenčno zdravilo.
It is not intended to provide practical advice on how to use Inflectra.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information on biosimilar medicines, see the question-and-answer document here.
Za več informacij o biološko podobnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
This is a summary of the European public assessment report (EPAR) for Inflectra.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Inflectra.
Inflectra was compared with Remicade in one main study involving 606 adult patients with rheumatoid arthritis.
Zdravilo Inflectra so primerjali z zdravilom Remicade v eni glavni študiji, v katero je bilo vključenih 606 odraslih bolnikov z revmatoidnim artritisom.
Inflectra is also used in patients aged between six and 17 years with severe, active Crohn's disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Zdravilo Inflectra se uporablja tudi pri bolnikih, starih od 6 do 17 let, s hudo aktivno Crohnovo boleznijo ali močno aktivnim ulceroznim kolitisom, ki se niso odzvali na druga zdravila ali zdravljenja ali pa jih ne smejo prejemati.
To reduce the risk of infusion-related reactions, patients may be given other medicines before or during treatment with Inflectra or the infusion time may be slowed down.
Za zmanjšanje tveganja za pojav reakcij, povezanih z infundiranjem, lahko bolniki pred ali med zdravljenjem z zdravilom Inflectra prejmejo druga zdravila ali pa se upočasni hitrost infundiranja.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Inflectra has been shown to have a comparable quality, safety and efficacy profile to Remicade.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Inflectra podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Remicade.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna določeno strukturo (imenovano antigen) v telesu in se veže nanjo.
The Committee recommended that Inflectra be approved for use in the EU.
Odbor je priporočil, da se zdravilo Inflectra odobri za uporabo v EU.
Inflectra is given as an infusion lasting one or two hours.
Zdravilo Inflectra se daje v obliki infuzije, ki traja eno ali dve uri.
The most common side effects with Inflectra (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Najpogostejši neželeni učinki zdravila Inflectra (ki lahko prizadenejo več kot 1 osebo od 10) so virusne okužbe (na primer gripa ali herpes), glavobol, okužbe zgornjih dihal (prehladi), sinusitis (vnetje sinusov), navzeja (slabost), bolečine v trebuhu (bolečine v želodcu), reakcije, povezane z infundiranjem, in bolečine.
In addition, the company that markets Inflectra will provide educational material to doctors who are expected to prescribe the medicine in adults and children including information on the safety of the medicine and an alert card to be given to patients.
Poleg tega bo družba, ki trži zdravilo Inflectra, zagotovila izobraževalno gradivo za zdravnike, ki naj bi predpisovali zdravilo odraslim in otrokom, vključno z informacijami o varnosti zdravila in opozorilno kartico za bolnike.
Inflectra is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Zdravilo Inflectra se pri revmatoidnem artritisu običajno daje v odmerku 3 mg na kilogram telesne mase, ki se ga lahko po potrebi poveča.
A risk management plan has been developed to ensure that Inflectra is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Inflectra je bil pripravljen načrt obvladovanja tveganj.
It can only be obtained with a prescription and treatment should be started and supervised by a specialised doctor who has experience in the diagnosis and treatment of the diseases that Inflectra can be used to treat.
Izdaja zdravila je le na recept, zdravljenje z njim pa mora začeti in nadzorovati zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, ki se lahko zdravijo z zdravilom Inflectra.
What benefits of Inflectra have been shown in studies?
Kakšne koristi je zdravilo Inflectra izkazalo v študijah?
Therefore, the CHMP's view was that, as for Remicade, the benefit outweighs the identified risks.
Zato je menil, da so njegove koristi, tako kot pri zdravilu Remicade, večje od znanih tveganj.
Inflectra is used with methotrexate (a medicine that acts on the immune system);
Inflectra se uporablja skupaj z metotreksatom (zdravilom, ki deluje na imunski sistem);
Patients who receive Inflectra must be given a special alert card that summarises the safety information about the medicine.
Bolniki, ki prejemajo zdravilo Inflectra, morajo prejeti posebno opozorilno kartico, na kateri so povzete informacije o varnosti zdravila.
It is usually used when other medicines or treatments have failed, in adults with the following diseases:
Običajno se uporablja pri odraslih z naslednjimi boleznimi, kadar druga zdravila ali zdravljenja niso učinkovita:
Inflectra must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Inflectra.
Zdravila Inflectra ne smejo uporabljati bolniki, ki so bili v preteklosti preobčutljivi za (alergični na) infliksimab, in bolniki, ki so preobčutljivi za (alergični na) mišje beljakovine ali katero koli drugo sestavino zdravila Inflectra.
An additional study was also carried involving 250 patients with ankylosing spondylitis out to show that Inflectra produces levels of the active substance in the body that are comparable to the reference medicine, Remicade.
Opravili so tudi dodatno študijo z 250 bolniki z ankilozirajočim spondilitisom, s katero so želeli dokazati, da so ravni zdravilne učinkovine v telesu po uporabi zdravila Inflectra primerljive z ravnmi po uporabi referenčnega zdravila Remicade.
Other information about Inflectra
Druge informacije o zdravilu Inflectra
After 30 weeks of treatment Inflectra was as effective as Remicade with around 60 % of patients responding to treatment with either medicine.
Po 30 tednih zdravljenja je bilo zdravilo Inflectra enako učinkovito kot zdravilo Remicade, pri čemer se je na zdravljenje s posameznim zdravilom odzvalo približno 60 % bolnikov.
The reference medicine for Inflectra is Remicade.
Referenčno zdravilo za zdravilo Inflectra je Remicade.
What are the risks associated with Inflectra?
Kakšna tveganja so povezana z zdravilom Inflectra?
For more information about treatment with Inflectra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Inflectra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Inflectra approved?
Zakaj je bilo zdravilo Inflectra odobreno?
Inflectra must not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure (an inability of the heart to pump enough blood around the body).
Zdravilo Inflectra se ne sme uporabljati pri bolnikih s tuberkulozo, drugimi hudimi okužbami ali zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj velike količine krvi skozi telo).
Patients received either Inflectra or Remicade in addition to methotrexate for 30 weeks.
Bolniki so 30 tednov prejemali bodisi zdravilo Inflectra bodisi Remicade skupaj z metotreksatom.
What is Inflectra and what is it used for?
Kaj je zdravilo Inflectra in za kaj se uporablja?
By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of the diseases.
Z zaviranjem faktorja TNF-alfa infliksimab olajša vnetje in druge simptome bolezni.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inflectra, 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 uporabo za zdravilo Inflectra vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Inflectra was studied to show that it is comparable to the reference medicine, Remicade.
Zdravilo Inflectra so raziskali, da bi dokazali njegovo primerljivost z referenčnim zdravilom Remicade.
Infliximab has been designed to attach to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Infliksimab je bil zasnovan tako, da se v telesu veže na kemični prenašalec, imenovan tumorski nekrozni faktor alfa (TNF-alfa).
For practical information about using Inflectra, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Inflectra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Inflectra is used to treat.
Ta prenašalec sodeluje pri povzročanju vnetja in ga je pri bolnikih z boleznimi, za zdravljenje katerih se uporablja zdravilo Inflectra, mogoče najti v velikih koncentracijah.
‘Inflectra is a ‘biosimilar' medicine.
Inflectra je „biološko podobno“ zdravilo.
• Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
• Crohnovo boleznijo (boleznijo, ki povzroča vnetje prebavnega trakta), ki je zmerna do huda ali fistulirajoča (s fistulami, tj. nenormalnimi prehodi med črevesjem in drugimi organi);
The active substance in Inflectra, infliximab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilu Inflectra, infliksimab, je monoklonsko protitelo.
For the full list of all side effects reported with Inflectra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Inflectra, glejte navodilo za uporabo.
See the summary of product characteristics (also part of the EPAR) for full details.
Za več informacij glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Inflectra is an anti-inflammatory medicine that contains the active substance infliximab.
Inflectra je protivnetno zdravilo, ki vsebuje zdravilno učinkovino infliksimab.
How is Inflectra used?
Kako se zdravilo Inflectra uporablja?
Inflectra is available as a powder to be made up into a solution for infusion (drip) into a vein.
Zdravilo Inflectra je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
• rheumatoid arthritis (an immune-system disease causing inflammation of the joints).
• revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov).
All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
Med infundiranjem in še najmanj eno do dve uri po njem je treba preverjati, ali so se pri bolniku pojavile kakršne koli reakcije.
The infliximab is made by cells that have received a gene (DNA), which makes them able to produce it.
Zdravilo Inflectra se pridobiva s t. i. „tehnologijo rekombinantne DNK“, pri kateri infliksimab izdelajo celice, ki so prejele gen (DNK), s pomočjo katerega ga lahko tvorijo.
• psoriasis (a disease causing red, scaly patches on the skin).
• psoriazo (boleznijo, ki povzroča rdeče luskaste zaplate na koži).
• ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine);
• ankilozirajočim spondilitisom (boleznijo, ki povzroča vnetje in bolečino v sklepih v hrbtenici);
• psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints);
• psoriatičnim artritisom (boleznijo, ki povzroča rdeče luskaste zaplate na koži in vnetje sklepov);
• ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
• ulceroznim kolitisom (boleznijo, ki povzroča vnetje in razjede na črevesni sluznici);
At any time:
Kadarkoli:
• Grade ≤1;
• stopnje ≤ 1;
* Not statistically significant.
Ni statistično pomembno.
Patients should be encouraged to take their dose at approximately the same time each day.
Bolnike je treba spodbujati, da vzamejo svoj odmerek vsak dan ob približno istem času.
Date of first authorisation: 09 November 2016
Datum prve odobritve: 9. november 2016
Approximately 20% of patients were pre/perimenopausal.
Približno 20 % bolnic je bilo v pred/perimenopavzi.
Urgent treatment may be necessary.
Morda boste potrebovali nujno zdravljenje.
The next prescribed dose should be taken at the usual time.
Naslednji predpisani odmerek mora vzeti ob običajnem času.
*If further dose reduction below 75 mg/day is required, discontinue the treatment.
*Če je potrebno nadaljnje zmanjšanje odmerka pod 75 mg/dan, zdravljenje prekinite.
Day 15 of first 2 cycles:
15. dan prvih 2 ciklov:
Coadministration should only be considered after careful evaluation of the potential benefits and risks.
Sočasna uporaba pride v poštev šele po skrbni oceni morebitnih koristi in tveganj.
Supportive PFS analyses were based on an Independent Central Radiology Review.
Podporne analize PFS so temeljile na neodvisnem osrednjem radiološkem pregledu.
This medicine contains lactose (found in milk or dairy products).
To zdravilo vsebuje laktozo (prisotna v mleku in mlečnih izdelkih).
Do not stop taking IBRANCE unless your doctor tells you to.
Zdravila IBRANCE ne prenehajte jemati, razen če vam tega ne naroči zdravnik.
However, no clinical data have been obtained on fertility in humans.
Vendar niso pridobili nobenih kliničnih podatkov o plodnosti pri ljudeh.
Your doctor will tell you how many capsules of IBRANCE to take.
Zdravnik vam bo povedal, koliko kapsul zdravila IBRANCE morate vzeti.
Take the carton and this leaflet, so that the doctor knows what you have been taking.
S seboj vzemite škatlo in to navodilo za uporabo, da bo zdravnik vedel, kaj ste vzeli.
IBRANCE may reduce the number of your white blood cells and weaken your immune system.
Zdravilo IBRANCE lahko zmanjša število vaših belih krvnih celic in oslabi vaš imunski sistem.
If you have taken too much IBRANCE, see a doctor or go to a hospital immediately.
Če ste vzeli preveč zdravila IBRANCE, nemudoma obiščite zdravnika ali pojdite v bolnišnico.
If you feel unusually tired, take special care when driving or using machines.
Če se počutite nenavadno utrujeni, bodite pri upravljanju vozil in strojev posebno previdni.
Resume at next lower dose.
Nadaljujte z naslednjim manjšim odmerkom.
At the data cutoff date of 26-February-2016, the study met its primary objective of improving PFS.
Na datum zaključka zajema podatkov, 26. februarja 2016, je preskušanje doseglo svoj primarni cilj izboljšanja PFS.
- if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na palbociklib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
You will have regular blood tests during treatment to check whether IBRANCE affects your blood cells (white blood cells, red blood cells, and platelets).
Med zdravljenjem boste imeli redne preiskave krvi za preverjanje, ali zdravilo IBRANCE vpliva na vaše krvne celice (bele krvne celice, rdeče krvne celice in krvne ploščice).
Women of childbearing potential or their partners
Ženske v rodni dobi ali njihovi partnerji
Steady state was achieved within 8 days following repeated once daily dosing.
Stanje dinamičnega ravnovesja so dosegli v 8 dneh po ponavljajočem se odmerjanju enkrat na dan.
Blocking these proteins can slow down growth of cancer cells and delay the progression of your cancer.
Blokiranje teh beljakovin lahko upočasni rast rakavih celic in odloži napredovanje vašega raka.
Physicians should inform patients to promptly report any episodes of fever.
Zdravniki morajo bolnikom naročiti, naj takoj poročajo o vseh pojavih vročine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
N/A 42.1
N/V 42,1
After a median follow-up time of 45 months, the final OS analysis was performed based on 310 events (60% of randomised patients).
Po medianem času spremljanja 45 mesecev so opravili končno analizo OS na podlagi 310 dogodkov (60 % randomiziranih bolnikov).
The treatment with IBRANCE should be continued as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
Zdravljenje z zdravilom IBRANCE je treba nadaljevati, dokler ima bolnik od zdravljenja klinično korist ali dokler se ne pojavi nesprejemljiva toksičnost.
Withhold until symptoms resolve to:
Prekinite zdravljenje, dokler simptomi ne izzvenijo do:
IBRANCE with food and drink
Zdravilo IBRANCE skupaj s hrano in pijačo
These methods should be used during therapy and for at least 3 weeks after completing therapy for females and for at least 14 weeks for males.
Te metode je treba uporabljati med zdravljenjem in še najmanj 3 tedne po prenehanju zdravljenja za ženske in najmanj 14 tednov za moške.
Crossover between treatment arms was not allowed.
Prehajanje med zdravljenima skupinama ni bilo dovoljeno.
IBRANCE may affect the way some other medicines work.
Zdravilo IBRANCE lahko vpliva na delovanje nekaterih drugih zdravil.
Day 1 of cycle:
1. dan cikla:
i ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query
i. ILD/pnevmonitis vključuje vse PT, o katerih so poročali in ki so del standardizirane MedDRA
The safety and efficacy of IBRANCE in children and adolescents <18 years of age have not been established.
Varnost in učinkovitost zdravila IBRANCE pri otrocih in mladostnikih, starih < 18 let, nista bili dokazani.
Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Bolnice so prejemale dodeljeno zdravljenje do objektivnega napredovanja bolezni, poslabšanja simptomov, nesprejemljive toksičnosti, smrti ali preklica soglasja, karkoli je nastopilo prej.
In vitro studies with transporters
Študije in vitro s prenašalci
It may harm them, even if their signs of illness are the same as yours.
30,5 (27,4; NE) 19,3 (16,4; 30,6) 35,7 (27,7; 38,9) 19,5 (16,6; 26,6)
The median age of patients enrolled in this study was 57 years (range 29, 88).
Mediana starost bolnic, vključenih v to preskušanje, je bila 57 let (razpon 29, 88).
Comparator arms*
Primerjalne skupine*
When recovered to Grade ≤2, start the next cycle at the same dose.
Ko pride do izboljšanja na stopnjo ≤ 2, začnite naslednji cikel z enakim odmerkom.
Grade ≥3 non-haematological toxicity (if persisting despite medical treatment)
nehematološka toksičnost stopnje ≥ 3 (če vztraja kljub medicinski oskrbi)
IBRANCE is not to be used in children or adolescents (under 18 years of age).
Zdravila IBRANCE se ne sme uporabljati pri otrocih ali mladostnikih (starih manj kot 18 let).
No studies have been conducted in humans or animals to assess the effect of palbociclib on milk production, its presence in breast milk, or its effects on the breast-fed child.
Študij pri ljudeh ali živalih za oceno učinka palbocikliba na nastajanje mleka, njegovo prisotnost v materinem mleku ali njegovih učinkov na dojenega otroka niso izvedli.
These systemic toxicities were generally observed at clinically relevant exposures based on AUC.
Te sistemske toksičnosti so na splošno opažali pri klinično pomembnih izpostavljenostih na osnovi vrednosti AUC.
In the cell lines tested, the loss of retinoblastoma (Rb) was associated with loss of palbociclib activity.
V preskušenih celičnih linijah so izgubo retinoblastoma (Rb) povezali z izgubo aktivnosti palbocikliba.
You should not use IBRANCE if you are pregnant.
Zdravila IBRANCE ne smete uporabljati, če ste noseči.
If you experience certain side effects while you are taking IBRANCE (see section 4 “Possible side effects”), your doctor may lower your dose or stop treatment, either temporarily or permanently.
Če med jemanjem zdravila IBRANCE opazite določene neželene učinke (glejte poglavje 4, ''Možni neželeni učinki''), vam bo zdravnik morda zmanjšal odmerek ali prekinil zdravljenje, bodisi začasno ali trajno.
Grading according to CTCAE 4.0.
Stopnje po CTCAE 4.0.
If the patient vomits or misses a dose, an additional dose should not be taken that day.
Če bolnik bruha ali pozabi vzeti odmerek, na ta dan ne sme vzeti dodatnega odmerka.
Based on an analysis of the cumulative pharmacokinetic, safety, and efficacy data across Asian and non-Asian populations, no dose adjustment based on Asian race is considered necessary.
Na podlagi analize združenih podatkov o farmakokinetiki, varnosti in učinkovitosti pri azijski in neazijski populaciji prilagajanje odmerka na podlagi azijske rasne pripadnosti ni potrebno.
Dose modification of IBRANCE is recommended based on individual safety and tolerability.
Odmerek zdravila IBRANCE je priporočljivo prilagoditi glede na posameznikovo varnost in prenašanje.
PVC/PCTFE/PVC/Al blister strip containing 7 hard capsules (one capsule per cell).
Pretisni omot iz PVC/PCTFE/PVC/Al, ki vsebuje 7 trdih kapsul (ena kapsula na žepek).
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies.
Dajemo ga skupaj z zaviralci aromataze ali fulvestrantom, ki se uporabljajo za hormonsko zdravljenje raka.
What IBRANCE is and what it is used for 2.
Kaj je zdravilo IBRANCE in za kaj ga uporabljamo 2.
Palbociclib is not a substrate of OATP1B1 or OATP1B3.
Palbociklib ni substrat OATP1B1 in OATP1B3.
Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to
Pogostnosti neželenih učinkov so opredeljene na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
Secondary efficacy endpoints included objective response (OR), clinical benefit response (CBR), safety, and change in quality of life (QoL).
Sekundarni opazovani dogodki učinkovitosti so vključevali objektivni odziv (OR - Objective Response), odziv klinične koristi (CBR - Clinical Benefit Response), varnost in spremembo v kakovosti življenja (QoL - Quality of Life).