natgillin/translations-raw huggingface dataset:
Tell your doctor or pharmacist if you notice any of the side effects above.
Drugi neželeni učinki Obvestite svojega zdravnika ali farmacevta, če opazite katerega od naslednjih neželenih učinkov:
• Permanently discontinue Nerlynx treatment
• Trajno ukinite dajanje zdravila Nerlynx.
Estimated 2 year event free rates1 (%)
Ocenjene stopnje brez dogodkov po dveh letih1
Concomitant treatment with substances that increase gastric pH should be avoided, as neratinib solubility and absorption may decrease.
Zaviralci protonske črpalke, antagonisti receptorja H2 in antacidi Topnost neratiniba je odvisna od vrednosti pH. Sočasnemu zdravljenju z učinkovinami, ki povečujejo vrednost pH želodčne kisline, se je treba izogibati, saj se topnost in absorpcija neratiniba lahko zmanjšata.
• Remark on importance of reading the PIL • Remarks on the importance of reporting ADRs
o kdaj obvestiti zdravstvene delavce in pomembnost obveščanja za nadaljnjo prilagoditev zdravljenja; • opomba o pomembnosti branja navodila za uporabo;
After discontinuation of a strong CYP3A4/P-gp inhibitor, resume previous dose of Nerlynx 240 mg (see Section 4.4 and Section 4.5).
Po prekinitvi jemanja močnega zaviralca CYP3A4/P-gp znova začnite dajati prejšnji odmerek zdravila Nerlynx
There were 0.2% of Nerlynx treated patients who experienced Grade 3 nail disorder.
pa pri 0,2 % bolnikov, zdravljenih z zdravilom Nerlynx, in pri 0,0 % bolnikov, zdravljenih s placebom.
• If diarrhoea resolves to Grade 0-1 in longer than one week, then resume Nerlynx treatment at reduced dose (see Table 1).
• Če se izboljšanje na stopnjo ≤ 1 pojavi v treh tednih, znova začnite dajati zdravilo Nerlynx v naslednji zmanjšani velikosti odmerka.
UNIQUE IDENTIFIER - HUMAN READABLE DATA
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI Škatla :
Some side effects associated with taking more Nerlynx than you should are: diarrhoea, nausea, vomiting and dehydration.
Nekateri neželeni učinki, povezani s tem, da ste vzeli več zdravila Nerlynx, kot bi smeli, so driska,
Renal impairment
Stanje bezgavk
Your doctor will stop your treatment with Nerlynx if your liver tests show severe problems.
Če bodo testi delovanja jeter pokazali hude težave, bo zdravnik zdravljenje z zdravilom Nerlynx prekinil.
Very Common Decreased appetite Common
Preiskave pogosti zmanjšana telesna masa
The frequency and severity of gastrointestinal disorders (diarrhoea, abdominal pain, nausea and vomiting) appeared to be dose-related.
Izkazalo se je, da sta pogostnost in resnost bolezni prebavil (driske,
Grade 3 ALT increased was reported in 1.1% vs 0.2% and Grade 4 ALT increased was reported in 0.2% vs 0.0% of Nerlynx- vs placebotreated patients.
1,1 % bolnikov, zdravljenih z zdravilom Nerlynx, in pri 0,2 % bolnikov, zdravljenih s placebom, o neželenih učinkih stopnje 4 zaradi povečane vrednosti ALT pa pri 0,2 % bolnikov, zdravljenih z zdravilom Nerlynx, in pri 0,0 % bolnikov, zdravljenih s placebom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN PLASTENKA
o The Summary of Product Characteristics o Guide for healthcare professionals o Patient educational material The Guide for healthcare professionals shall contain the following key elements: o Name of the product, active substance and approved indication of the product o Relevant information on the safety concern “Gastrointestinal toxicity (diarrhoea)” (e.g. seriousness, severity, frequency, time to onset, duration, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern o Key message to convey in patients counselling on how to prevent and minimise Gastrointestinal toxicity through appropriate monitoring and management: o prophylactic treatment with antidiarrhoeal medicinal product o dietary changes o dose modification (with guideline to adjust doses)/ discontinuation of treatment o The importance of handing over the educational material to the patients/carers at the end of counselling o Remarks on the importance of reporting ADRs
o podrobnosti o populaciji, pri kateri je tveganje za varnost večje; o ključno sporočilo, ki ga je treba podati pri svetovanju bolnikom o tem, kako preprečiti in zmanjšati toksičnost za prebavila z ustreznim spremljanjem in obvladovanjem:
• Fluid intake of ~2 L should be maintained to avoid dehydration
• Za preprečevanje dehidracije je treba dnevno vnesti ~ 2 l tekočine.
• If grade 3 diarrhoea persists longer than 3weeks, discontinue Nerlynx permanently.
• Če je driska stopnje 3 prisotna več kot tri tedne,
Grade 3 adverse reactions were reported in 1.6% vs 0.5% and Grade 4 adverse reactions were reported in 0.2% vs. 0.1%, Nerlynx- and placebo-treated patients, respectively.
bolnikov, zdravljenih z zdravilom Nerlynx, in pri 0,5 % bolnikov, zdravljenih s placebom, o neželenih učinkih stopnje 4 pa pri 0,2 % bolnikov, zdravljenih z zdravilom Nerlynx, in pri 0,1 % bolnikov,
Infections and infestations
Infekcijske in parazitske bolezni pogosti okužbe sečil
Sequential
Zaporedno
Very common Fatigue
Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost
In the multicentre, randomised, double-blind, placebo-controlled, pivotal phase III study, ExteNET (3004), 2,840 women with early-stage HER2-positive breast cancer (as confirmed locally by assay)
Klinična učinkovitost in varnost V multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani ključni študiji III. faze,
2 Includes rash, rash erythematous, rash follicular, rash generalised, rash pruritic, and rash pustular.
2 Vključuje izpuščaj in eritematozni, folikularni, generaliziran, pruritični ter pustularni izpuščaj.
- The active substance is neratinib.
- Učinkovina je neratinib.
Following single doses of neratinib, the mean apparent plasma half-life of neratinib was 17 hours in patients.
Pri bolnikih je bil povprečni navidezni razpolovni čas v plazmi po enkratnih odmerkih neratiniba
The incidence of serious adverse reactions in the Nerlynx arm vs placebo arm was 7.0% vs. 5.7% (<65 years-old) and 9.9% vs. 8.1% (≥65 years-old).
Pojavnost resnih neželenih učinkov je v kraku z zdravilom Nerlynx znašala 7,0 % (pri bolnikih, starih
The difference was between 4.8 and 11.8% depending on the type of chemotherapy.
Razlika je znašala od 4,8 % do 11,8 % odvisno od vrste kemoterapije.
The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin on 28 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom Herceptin, veljavno po vsej Evropski uniji, odobrila dne 28. avgusta 2000.
Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Bolniki, ki prenesejo prvo 90-minutno infuzijo, lahko prejmejo naslednje infuzije v trajanju 30 minut.
The full EPAR for Herceptin 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 Herceptin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
All the above studies were in patients whose cancers expressed HER2.
Vse zgoraj omenjene študije so potekale na bolnikih, katerih rak je izražal HER2.
This document is a summary of the European public assessment report (EPAR) for Herceptin.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Herceptin.
Herceptin can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Zdravilo Herceptin lahko povzroči kardiotoksičnost (poškodbe srca), vključno s srčnim popuščanjem (ko srce ne deluje tako dobro, kot bi moralo).
Other information about Herceptin:
Druge informacije o zdravilu Herceptin:
Herceptin is used to treat the following types of cancer:
Zdravilo Herceptin se uporablja za zdravljenje naslednjih vrst raka:
It is used on its own in patients in whom previous treatments have failed.
Uporablja se samostojno za zdravljenje bolnic, pri katerih je bilo predhodno zdravljenje neuspešno.
The CHMP decided that Herceptin's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Herceptin večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For more information about treatment with Herceptin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Herceptin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The studies measured how many patients died or had their cancer reappear or worsen.
V študijah so ugotavljali, koliko bolnic je umrlo, oziroma pri kolikih se je rak ponovil oziroma poslabšal.
Herceptin treatment should only be started by a doctor who has experience in the use of anticancer medicines.
Zdravljenje z zdravilom Herceptin lahko uvede le zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Herceptin.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Herceptin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Herceptin shown during the studies?
Kakšne koristi je zdravilo Herceptin izkazalo med študijami?
Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.
Posebna skrb je potrebna, kadar ga uporabljajo bolniki, ki že imajo težave s srcem ali visokim krvnim tlakom, pri vseh bolnikih pa je delovanje srca med zdravljenjem in po njem treba nadzorovati.
Herceptin is a medicine that contains the active substance trastuzumab.
Herceptin je zdravilo, ki vsebuje zdravilno učinkovino trastuzumab.
Herceptin must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Zdravila Herceptin ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) trastuzumab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
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) that is found on certain cells in the body.
To je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen), ki se nahaja na določenih celicah v telesu, in se veže nanjo.
These studies measured how many patients responded to treatment, or how long they lived without their cancer getting worse.
V obeh študijah so ugotavljali, koliko bolnic se je odzvalo na zdravljenje ali koliko časa so živele, ne da bi se bolezen poslabšala.
The first study was in patients who had first been treated with surgery, chemotherapy and radiotherapy (if applicable).
Prva študija je zajemala bolnice, ki so bile najprej zdravljene z operacijo, kemoterapijo in radioterapijo (če je bilo ustrezno).
For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Pri zgodnjem raku dojke se zdravilo uporablja eno leto ali do ponovnega izbruha bolezni, pri metastatskem raku dojk ali želodca se zdravljenje nadaljuje, dokler je učinkovito.
The most common or serious side effects with Herceptin are heart problems, infections, lung and blood problems, and reactions related to the way Herceptin is given.
Najpogostejši ali najresnejši neželeni učinki zdravila Herceptin so težave s srcem, okužbe, težave s pljuči in krvjo ter reakcije, povezane z načinom dajanja zdravila Herceptin.
It is also used in combination with other anticancer medicines: with paclitaxel or docetaxel, or with an aromatase inhibitor;
Uporablja se tudi v kombinaciji z drugimi zdravili proti raku: s paklitakselom ali docetakselom ali v kombinaciji z inhibitorjem aromataze;
When used as an infusion into a vein, Herceptin can also be used for:
Kot infuzija v veno se lahko zdravilo Herceptin uporablja tudi za zdravljenje:
It must not be used in patients who have serious breathing problems when they are at rest because of advanced cancer, or who need oxygen therapy.
Prav tako ga ne smejo uporabljati bolniki, ki imajo zaradi napredovalega raka v mirovanju velike težave z dihanjem ali potrebujejo zdravljenje s kisikom.
In early breast cancer, Herceptin given by infusion into a vein has been studied in five main studies involving around 10,000 patients.
Pri zgodnjem raku dojke so zdravilo Herceptin, dano v obliki infuzije v veno, proučevali v petih glavnih študijah, v katerih je sodelovalo okoli 10 000 bolnic.
When given as an infusion into a vein, Herceptin is given over 90 minutes every week or every three weeks for breast cancer, and every three weeks for gastric cancer.
Zdravilo Herceptin se kot infuzija v veno daje v trajanju 90 minut vsak teden ali vsake tri tedne pri raku dojk ter vsake tri tedne pri raku želodca.
Patients receiving Herceptin in combination with anastrozole also lived for longer without their cancer getting worse (4.8 months, on average) than those receiving anastrozole alone (2.4 months, on average).
Bolnice, ki so prejemale zdravilo Herceptin v kombinaciji z anastrozolom, so tudi živele dlje, ne da bi se bolezen poslabšala (povprečno 4,8 meseca), kot tiste, ki so prejemale samo anastrozol (povprečno 2,4 meseca).
When given as an injection under the skin, the recommended dose of Herceptin does not depend on the patient's body weight and is 600 mg given over 2 to 5 minutes every three weeks.
Priporočeni odmerek zdravila Herceptin, ki se daje v obliki injekcije pod kožo, ni odvisen od telesne mase bolnika, ampak znaša 600 mg in se daje v trajanju 2 do 5 minut vsake tri tedne.
Herceptin can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Zdravilo Herceptin se uporablja pri tistih oblikah raka, ki preveč izražajo HER2: to pomeni, da na površini rakavih celic v velikih količinah nastaja beljakovina, imenovana HER2, kar povzroča hitrejšo rast tumorskih celic.
The active substance in Herceptin, trastuzumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Herceptin, trastuzumab, je monoklonsko protitelo.
HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
HER2 je preveč izražen pri približno četrtini primerov raka dojke in petini primerov raka želodca.
What is the risk associated with Herceptin?
Kakšna tveganja so povezana z zdravilom Herceptin?
In the study comparing Herceptin given under the skin and by infusion into a vein, some side effects have been reported more frequently with Herceptin given under the skin: infections with or without neutropenia (low levels of neutrophils, a type of white blood cells), heart problems, reactions related to the way Herceptin is given and high blood pressure.
V študiji, v kateri so primerjali zdravilo Herceptin, dano pod kožo, z zdravilom Herceptin, danim v veno, so bili pri uporabi zdravila, danega pod kožo, nekateri učinki pogostejši: okužbe z nevtropenijo (nizkimi ravnmi nevtrofilcev, vrsto belih krvnih celic) ali brez, težave s srcem, reakcije, povezane z načinom dajanja zdravila Herceptin, in visok krvni tlak.
The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Ker lahko infundiranje zdravila sproži alergijsko reakcijo, je treba bolnike med infundiranjem in po njem nadzorovati.
When used in combination with paclitaxel or docetaxel, around half of the patients responded to Herceptin, compared with around a quarter of those receiving paclitaxel or docetaxel alone.
Kjer so zdravilo Herceptin uporabljali skupaj s paklitakselom ali docetakselom, se je na zdravilo Herceptin odzvala približno polovica bolnic v primerjavi s četrtino tistih, ki so prejemale samo paklitaksel ali docetaksel.
For the full list of all side effects reported with Herceptin, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Herceptin, glejte navodilo za uporabo.
In the first study in early breast cancer, 8% of the patients who received Herceptin by infusion into a vein after having completed surgery, chemotherapy and radiotherapy (if applicable) experienced a reappearance of their cancer in the first year of treatment (127 out of 1,693), compared with 13% of the patients who did not receive it (219 out of 1,693).
V prvi študiji zgodnjega raka dojke je pri 8 % (127 od 1 693) bolnic, ki so prejemale zdravilo Herceptin v obliki infuzije v veno po opravljeni operaciji, kemoterapiji in radioterapiji (če je ustrezno), prišlo do vnovičnega pojava raka v prvem letu zdravljenja v primerjavi s 13 % (219 od 1 693) bolnic, ki zdravila niso prejemale.
• early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
• zgodnjega raka dojke (ki se je razširil v dojki ali na žleze pod pazduho, vendar ne na druge dele telesa) po operaciji, kemoterapiji (uporabi zdravil za zdravljenje raka) in radioterapiji (zdravljenju z obsevanjem), če je primerno; Uporablja se lahko tudi na začetku zdravljenja skupaj s kemoterapijo.
Herceptin was given before surgery and the main measure of effectiveness was response to treatment assessed by measuring the proportion of patients who had no cancerous cells found on examination of the breast removed by surgery.
Zdravilo Herceptin so bolnice prejele pred operacijo, glavno merilo učinkovitosti pa je bil odziv na zdravljenje, merjen z deležem bolnic, pri katerih pri pregledu dojk, odstranjenih z operacijo, niso našli rakavih celic.
The recommended dose depends on the patient's body weight and depends on the condition to be treated and whether Herceptin is given weekly or three-weekly.
Priporočeni odmerek je odvisen od telesne mase bolnika, vrste zdravljene bolezni, in od tega, ali se zdravilo Herceptin daje tedensko ali vsake tri tedne.
For locally advanced breast cancer, giving Herceptin by infusion into a vein before surgery in combination with chemotherapy and then again after surgery on its own resulted in fewer patients dying or having their cancer worsen or reappear over three years: after three years, 65% of patients given Herceptin were still alive without having their cancer worsen or reappear as compared to 52% in patients not given Herceptin.
Pri lokalno napredovalem raku dojke je dajanje zdravila Herceptin v obliki infuzije v veno pred kirurškim posegom v kombinaciji s kemoterapijo in uporabljenega samostojno po operaciji pomenilo manj smrtnih primerov ali primerov poslabšanja oziroma vnovičnega pojava raka po treh letih: po treh letih je 65 % bolnic še vedno živelo brez poslabšanja bolezni ali vnovičnega pojava raka v primerjavi z 52 % bolnic, ki niso prejemale zdravila Herceptin.
For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herceptin is used before surgery in combination with chemotherapy and then again after surgery on its own;
Pri lokalno napredovalih tumorjih (tudi vnetnih) ali tistih, ki so širši od dveh centimetrov, se zdravilo Herceptin uporablja pred kirurškim posegom v kombinaciji s kemoterapijo, po njem pa se uporabi samostojno;
The addition of Herceptin to chemotherapy resulted in fewer patients experiencing a reappearance of their cancer over three years.
Zaradi dodajanja zdravila Herceptin kemoterapiji je v treh letih do vnovičnega pojava raka prišlo pri manj bolnicah.
In metastatic gastric cancer, the patients with higher levels of HER2 expression who received Herceptin by infusion into a vein survived for an average of 16.0 months, compared with 11.8 months in those receiving cisplatin and either capecitabine or 5-fluorouracil alone.
Pri metastatskem raku želodca so bolniki z višjimi ravnmi izraženosti HER2, ki so prejemali zdravilo Herceptin v obliki infuzije v veno, preživeli povprečno 16 mesecev v primerjavi z 11,8 meseca pri tistih, ki so prejemali samo kombinacijo cisplatina in bodisi kapecitabina ali 5-fluorouracila.
The levels of the active substance were at least as high as when Herceptin is given by infusion into a vein.
Koncentracija zdravilne učinkovine je bila vsaj tako visoka kot takrat, ko je bilo zdravilo Herceptin dano v obliki infuzije v veno.
Why has Herceptin been approved?
Zakaj je bilo zdravilo Herceptin odobreno?
• metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5-fluorouracil (other anticancer medicines).
• metastatskega raka želodca v kombinaciji s cisplatinom in bodisi kapecitabinom ali 5-fluoroacilom
In metastatic breast cancer, Herceptin given by infusion into a vein has been studied in four main studies: one looked at Herceptin on its own in 222 patients whose previous treatment had failed; two looked at Herceptin in combination with paclitaxel or docetaxel in a total of 657 patients; and one looked at the combination of Herceptin and anastrozole (an aromatase inhibitor) in 208 women who had been through the menopause.
Pri metastatskem raku dojke so zdravilo Herceptin, dano kot infuzija v veno, proučevali v štirih glavnih študijah: v eni študiji so raziskovali samostojno uporabo zdravila Herceptin pri 222 bolnicah, pri katerih predhodna zdravljenja niso bila uspešna, drugi dve sta raziskovali uporabo zdravila Herceptin v kombinaciji s paklitakselom ali docetakselom pri skupaj 657 bolnicah, v zadnji pa so proučevali kombinacijo zdravila Herceptin in anastrozola (zaviralca aromataze) pri 208 bolnicah po končani menopavzi.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Z vezavo nanjo aktivira celice imunskega sistema, ki nato uničijo tumorske celice.
A fifth study, in patients with locally advanced or inflammatory breast cancer, looked at the effect of giving Herceptin before surgery in combination chemotherapy and then again after surgery on its own.
V peti študiji so pri bolnicah z lokalno napredovalim ali vnetnim rakom dojke proučevali učinke dodajanja zdravila Herceptin pred kirurškim posegom v kombinaciji s kemoterapijo ter nato uporabljenega samostojno po operaciji.
It is available as a powder to be made up into a solution for infusion (drip) into a vein or as a solution for injection under the skin.
Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno) ali raztopine za injiciranje v podkožje.
Trastuzumab has been designed to attach to HER2, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Trastuzumab je zasnovan tako, da se veže na beljakovino HER2, ki je preveč izražena pri približno četrtini primerov raka dojke in petini primerov raka želodca.
When given by injection under the skin, Herceptin had the same effectiveness as when given by infusion into a vein.
Zdravilo Herceptin, injicirano pod kožo, je bilo enako učinkovito kot takrat, ko je bilo dano v obliki infuzije v veno.
Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.
Trastuzumab beljakovini HER2 prepreči tvorjenje signalov, ki povzročajo rast tumorskih celic.
The study also compared the levels of the active substance in the blood for Herceptin given under the skin and into a vein to demonstrate that sufficient levels are obtained when given under the skin.
V študiji so pri zdravilu Herceptin, danem pod kožo in v veno, primerjali tudi koncentracije zdravilne učinkovine v krvi, da bi dokazali, da je pri dajanju zdravila pod kožo dosežena zadostna koncentracija.
What is Herceptin used for?
Za kaj se zdravilo Herceptin uporablja?