natgillin/translations-raw huggingface dataset:
Skin reactions (e.g. rash, urticaria).
Kožne reakcije (npr. izpuščaj, koprivnica).
Section 4.4 Special warnings and precautions for use [This section should be amended to reflect the following wording] Because of the potential serious safety concerns (in particular fibrotic reactions), methysergide should only be used after other treatment have failed.
Zaradi možnosti resnih pomislekov glede varnosti (še posebej fibrotičnih reakcij) se sme metizergid uporabljati šele po neuspehu drugih zdravljenj.
During clinical assessment of the patient, particular attention should be paid to complaints of: abdominal, loin or chest pain, palpitations, dyspnoea, dry cough, nausea, malaise, fatigue, anorexia/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Med klinično oceno bolnika je treba posvetiti posebno pozornost poročilom o: bolečini v trebuhu, ledjih ali prsih, palpitacijah, dispneji, suhem kašlju, navzei, slabem počutju, utrujenosti, anoreksiji/izgubi telesne mase, urinarnih simptomih, bolečini/hladnosti/omrtvičenosti v udih.
Retroperitoneal Fibrosis may occur.
Lahko pride do retroperitonealne fibroze.
Fibrotic symptoms of the pleura are: chest pain and shortness of breath, dry cough and weight loss.
Simptomi fibroze pljučne mrene so: bolečina v prsih in zasoplost, suh kašelj in izguba telesne mase.
Fibrosis of the retroperitoneum can cause symtpoms such general discomfort, back pain, waist- or rib pain, pain during urination, reduced urine production, loss of appetite and skin discolouration in the legs.
Fibroza trebušne mrene lahko povzroči simptome, kot so splošno nelagodje, bolečina v hrbtu, bolečina v pasu ali rebrih, bolečina med uriniranjem, zmanjšana količina urina, izguba apetita in razbarvanje kože na nogah.
The duration of continuous administration must not exceed six months.
Trajanje neprekinjene uporabe naj ne preseže šestih mesecev.
Pleuro-pulmonary fibrosis presents as precordial pains, dyspnoea, pleural frictional noise, lung basal crepitations or pleural effusion, digital clubbing, dry cough, anorexia and weight loss.
Plevropulmonalna fibroza se kaže kot prekordialne bolečine, dispneja, zvoki plevralnega trenja, pljučne bazalne krepitacije ali plevralni izliv, betičasti prsti, suh kašelj, anoreksija in izguba telesne mase.
Pleuro-pulmonary fibrosis (see General disorders), dyspnoea, pleurisy, pleural effusion.
Bolezni dihal, prsnega koša in mediastinalnega prostora Plevropulmonalna fibroza (glejte Splošne težave), dispneja, plevritis, plevralni izliv.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.> <Or> <[Invented name] contains lactose and sucrose.
Bolniki z redkimi dednimi težavami intolerance za galaktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze tega zdravila ne smejo jemati.> <ali> <Zdravilo [izmišljeno ime] vsebuje laktozo in sukrozo.
Pleuro-pulmonary fibrosis (see General disorders), difficulty of breath, pleura inflammation, presence of fluid in the pleura.
Bolezni dihal, prsnega koša in mediastinalnega prostora Plevropulmonalna fibroza (glejte Splošne težave), oteženo dihanje, vnetje pljučne mrene, tekočina v pljučni mreni.
Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.>
Bolniki z redkimi dednimi težavami intolerance za galaktozo ali fruktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze ali insuficience sukraze/izomaltaze tega zdravila ne smejo jemati.>
<Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take [Invented name].>
<Bolniki z redkimi dednimi težavami intolerance za galaktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze ne smejo jemati zdravila [izmišljeno ime].>
Always take [Invented name] exactly as your doctor has told you to.
Pri jemanju zdravila [izmišljeno ime] natančno upoštevajte navodila zdravnika.
<Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take [Invented name].>
<Bolniki z redkimi dednimi težavami intolerance za galaktozo ali fruktozo, laponske oblike pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze ali insuficience sukraze/izomaltaze ne smejo jemati zdravila [izmišljeno ime].>
How to take [Invented name] [This section should be amended to reflect the following wording] You should only get your medication initiated and supervised by a doctor who specialises in the treatment of migraine and cluster headache (neurologist).
To zdravilo smete začeti jemati le na podlagi odločitve zdravnika, ki je specializiran za zdravljenje migrene in glavobola v rafalih (nevrologa), in ta mora vaše zdravljenje tudi nadzorovati.
Cluster headache
Glavoboli v rafalih
Package Leaflet
Bolezni prebavil
6 August 2014
6. avgust 2014
Consequently, newborns should be monitored carefully.
Novorojenčke je zato treba skrbno spremljati.
The European Commission issued a decision on 6 August 2014.
Evropska komisija je sklep izdala 6. avgusta 2014.
• treatment of schizophrenia;
• zdravljenje shizofrenije;
Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Kvetiapin se zato lahko uporablja med nosečnostjo samo, če koristi upravičujejo možna tveganja.
Seroquel is available as tablets (25, 100, 150, 200 and 300 mg) while Seroquel XR is available as prolonged-release tablets (50, 150, 200, 300 and 400 mg).
Zdravilo Seroquel je na voljo v obliki tablet (25, 100, 150, 200 in 300 mg), zdravilo Seroquel XR pa v obliki tablet s podaljšanim sproščanjem (50, 150, 200, 300 in 400 mg).
Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Podaljšano sproščanje pomeni, da se zdravilna učinkovina počasi sprošča iz tablete nekaj ur.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je potrebna uskladitev informacij o predpisovanju teh zdravil v Evropski uniji (EU).
As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this affects signals transmitted between brain cells.
Ker so živčni prenašalci kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic, to vpliva na signale, ki se prenašajo med možganskimi celicami.
The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Natančen mehanizem delovanja kvetiapina ni znan, se pa veže na več receptorjev na površini živčnih celic v možganih, med katerimi so tudi receptorji za živčna prenašalca dopamin in serotonin.
The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use) and 4.8 (undesirable effects).
Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjema 4.4 (Posebna opozorila in previdnostni ukrepi) in 4.8 (Neželeni učinki).
This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
To je povzročilo razlike med državami članicami glede tega, kako se zdravili lahko uporabljata, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, v katerih se zdravili tržita.
Having reviewed the data available on the use of quetiapine during pregnancy, the CHMP concluded that no definite conclusion can be drawn on the risk of malformations in the unborn child when the medicine is used during early pregnancy (first trimester).
Potem ko je odbor CHMP pregledal razpoložljive podatke o uporabi kvetiapina med nosečnostjo, je zaključil, da ni mogoče podati dokončnega zaključka o tveganju za malformacije pri nerojenem otroku, kadar se zdravilo uporablja v zgodnji nosečnosti (v prvem trimesečju).
The company that markets these medicines is Astra Zeneca.
Zdravili trži farmacevtska družba Astra Zeneca.
The CHMP also harmonised the dosing recommendations, particularly how to increase the dose and the recommended daily dose.
Odbor CHMP je uskladil tudi priporočila za odmerjanje, zlasti v zvezi s povečevanjem odmerka in priporočenim dnevnim odmerkom.
After reviewing the available data supporting the use of the medicines, the CHMP agreed that Seroquel and Seroquel XR can continue to be used for the treatment of schizophrenia and treatment and prevention of bipolar disorder, but recommended harmonised wordings for these indications as follows:
Potem ko je odbor CHMP pregledal razpoložljive podatke v podporo uporabi teh zdravil, se je strinjal, da se lahko zdravili Seroquel in Seroquel XR še naprej uporabljata za zdravljenje shizofrenije ter zdravljenje in preprečevanje bipolarne motnje, vendar je za te indikacije priporočil naslednja usklajena besedila:
They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Uporabljata se pri bolnikih s shizofrenijo, tj. duševno boleznijo, ki ima vrsto simptomov, med katerimi so nepovezano razmišljanje in govorjenje, halucinacije (bolnik sliši ali vidi stvari, ki jih ni), sumničavost ter blodnje (zmotna prepričanja).
Since these neurotransmitters are involved in schizophrenia, bipolar disorder and major depression, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Ker omenjena živčna prenašalca sodelujeta pri shizofreniji, bipolarni motnji in hudi depresiji, kvetiapin pomaga normalizirati dejavnost možganov in s tem zmanjša simptome teh bolezni.
They are also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Prav tako se uporabljata za preprečevanje in zdravljenje bipolarne motnje, tj. duševne bolezni, pri kateri imajo bolniki manične epizode (obdobja nenormalno privzdignjenega razpoloženja), ki se izmenjujejo z obdobji normalnega razpoloženja, ter depresivne epizode.
Additionally, the data available show that newborns who were exposed to antipsychotics (including quetiapine) during late pregnancy (third trimester) are at risk of side effects including agitation, somnolence, breathing and feeding problems.
Poleg tega razpoložljivi podatki kažejo, da pri novorojenčkih, ki so izpostavljeni antipsihotikom (vključno s kvetiapinom) med pozno nosečnostjo (v tretjem trimesečju), obstaja tveganje za neželene učinke, kot so agitacija, somnolenca, težave z dihanjem in težave pri hranjenju.
Seroquel XR can also continue to be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Zdravilo Seroquel XR se lahko prav tako še naprej uporablja kot dopolnilno zdravljenje k obstoječemu zdravljenju velikih depresivnih epizod pri bolnikih z veliko depresivno motnjo, ki so imeli suboptimalni odziv na zdravljenje z drugimi antidepresivi.
• treatment of moderate to severe manic episodes in bipolar disorder and major depressive episodes in bipolar disorder;
• zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji in velikih depresivnih epizod pri bipolarni motnji;
• prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
• preprečevanje ponovnega pojava maničnih ali depresivnih epizod pri bolnikih z bipolarno motnjo, ki so se predhodno odzvali na zdravljenje s kvetiapinom.
On 22 May 2014, the European Medicines Agency completed a review of Seroquel and Seroquel XR.
Evropska agencija za zdravila je 22. maja 2014 zaključila pregled zdravil Seroquel in Seroquel XR.
Seroquel XR can also be used as add-on treatment in major depression.
Zdravilo Seroquel XR se lahko uporablja tudi kot dopolnilno zdravljenje pri hudi depresiji.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Odbor CHMP je na podlagi predloženih podatkov in znanstvene razprave v odboru menil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodilo za uporabo po vsej EU.
Seroquel and Seroquel XR are also marketed under other trade names.
Zdravili Seroquel in Seroquel XR se tržita tudi pod drugimi trgovskimi imeni.
Seroquel and Seroquel XR are authorised in the EU via national procedures.
Zdravili Seroquel in Seroquel XR sta bili v EU odobreni po nacionalnih postopkih.
Seroquel and Seroquel XR are antipsychotic medicines that contain the active substance quetiapine.
Zdravili Seroquel in Seroquel XR sta antipsihotika, ki vsebujeta zdravilno učinkovino kvetiapin.
Why were Seroquel and Seroquel XR reviewed?
Zakaj sta bili zdravili Seroquel in Seroquel XR pregledani?
What are Seroquel and Seroquel XR?
Kaj sta zdravili Seroquel in Seroquel XR?
On 12 June 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Seroquel and Seroquel XR in the EU.
Da bi uskladili dovoljenja za promet z zdraviloma Seroquel in Seroquel XR v EU, je Evropska komisija 12. junija 2013 zadevo napotila na odbor CHMP.
Seroquel and Seroquel XR were identified by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) as needing harmonisation.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravili Seroquel in Seroquel XR potrebno usklajevanje.
The use of Kepivance should be supervised by a doctor who has experience in anticancer therapy.
Zdravljenje z zdravilom Kepivance lahko izvaja samo zdravnik z izkušnjami pri zdravljenju raka.
The main measure of effectiveness was the number of days during which patients experienced severe oral
Glavna končna točka glede učinkovitosti v študiji je bilo število dni, ko so bolniki imeli hud oralni mukozitis (3./4.
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Three doses are given on three consecutive days before myeloablative therapy, finishing 24 to 48 hours before the therapy.
Prve tri odmerke je treba uporabiti pred mieloablacijsko terapijo, in sicer tako, da bolnik dobi tretji odmerek v 24 do 48 urah pred mieloablacijsko radiokemoterapijo.
It contains the active substance
Kaj vsebuje navodilo
Palifermin is very similar to a natural growth factor found in the body called keratinocyte growth factor (KGF).
Palifermin deluje enako kot keratinocitni rastni dejavnik (KGF), ki v majhni količini naravno nastaja v človeškem telesu.
Kepivance is a powder that is made up into a solution for injection.
6 vial s praškom za raztopino za injiciranje
Kepivance stimulates the growth of the epithelial cells, helping to reduce the incidence, severity and duration of oral mucositis in cancer patients undergoing intensive therapy.
Zdravilo Kepivance uporabljamo za zmanjšanje pogostosti, trajanja in izrazitosti simptomov oralnega mukozitisa.
Patients receiving Kepivance also reported less mouth and throat soreness with improved swallowing, drinking, eating and talking.
V klinični študiji 3. faze so bolniki, ki so dobivali palifermin, doživeli pomembne koristi v zvezi s samoopisanim izidom bolečin v ustih in žrelu ter njihovim vplivom na požiranje, pitje, hranjenje in govorjenje.
The study involved 281 adults who were receiving chemotherapy to treat multiple myeloma (a type of blood cancer), but without any radiotherapy.
V študiji (n = 281) so bili bolniki z multiplim mielomom pred avtologno presaditvijo krvotvornih matičnih celic deležni pripravljalne terapije z melfalanom (200 mg/m2).
Kepivance is used in adults who are likely to develop severe mucositis because they have blood cancer, and are being treated with myeloablative chemotherapy (medicines to destroy the bone marrow) in combination with radiotherapy (treatment with radiation) and an autologous haematopoietic stem-cell transplant (a transplant of their own blood-producing cells).
Za zdravljenje vašega krvnega raka morda dobivate kemoterapijo, radioterapijo in presaditev avtolognih hematopoetskih matičnih celic (krvotvornih celic iz vašega lastnega organizma).
In the main study, the patients receiving chemotherapy and radiotherapy had severe oral mucositis for a shorter time if they received Kepivance (3.7 days, on average) than if they received placebo (10.4 days, on average).
Poleg tega so pri bolnikih, ki so prejemali palifermin pred in po kemoterapiji, opazili večjo incidenco okužb (49,5 %), kot pri bolnikih, ki so prejemali placebo (24,6 %).
Other information about Kepivance:
Preiskave zelo pogosti:
Kepivance should not be used in people who may be hypersensitive (allergic) to palifermin, proteins produced by Escherichia coli (a bacterium) or any of the other ingredients.
- če ste alergični na palifermin, beljakovine, pridobljene iz bakterije Escherichia coli ali katerokoli drugo sestavino tega zdravila (navedeno v poglavju 6).
The European Commission granted a marketing authorisation valid throughout the European Union for Kepivance on 25 October 2005.
Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 23. september 2010
For the full list of all side effects reported with Kepivance, see the package leaflet.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The most common side effects with Kepivance (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), increased levels of lipase and amylase (enzymes used in digestion), hypertrophy (increase in the number or size of cells) or discoloration of the mouth and tongue, rash, pruritus (itching), erythema (redness), arthralgia (joint pain), oedema (swelling), pain and pyrexia (fever).
Učinkovitost in varnost palifermina so ugotavljali v randomizirani, dvojno slepi, s placebom kontrolirani študiji bolnikov s hematološkimi malignomi (ne-Hodgkinov limfom (NHL), Hodgkinova bolezen, akutna mieloična levkemija (AML), akutna limfatična levkemija (ALL), kronična mieloična levkemija (KML), kronična limfatična levkemija (KLL) ali multipli mielom).
How does Kepivance work?
Kepivance.
The remaining three doses are given on three consecutive days after myeloablative therapy, with the first dose given on the day of the stem-cell transplant.
Mediani čas do pojava je bil približno 6 dni po prvih 3 zaporednih dnevnih odmerkih zdravila Kepivance; mediano so trajali približno 5 dni.
Epithelial cells in the mouth are normally replaced by the body every few days.
Običajni odmerek zdravila Kepivance je 60 mikrogramov na kilogram telesne mase na dan.
At the request of the CHMP, the company carried out a further study comparing two schedules of Kepivance with placebo.
Nobena od zgornjih dveh shem odmerjanja ni pokazala statistično značilnih rezultatov v primerjavi s placebom.
The active substance in Kepivance, palifermin, is a growth factor that stimulates the ‘epithelial' cells that line the mouth and gastrointestinal tract to grow and develop.
V zdravilu Kepivance je rastni faktor, ki spodbuja proliferacijo epitelijskih celic z eksprimiranimi receptorji KGF.
Palifermin is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce palifermin.
Palifermin je humani keratinocitni rastni faktor (KGF - keratinocyte growth factor), pridobljen s tehnologijo rekombinantne DNA iz Escherichia coli.
It is given as an injection into a vein for a total of six doses.
Tak odmerek boste dobili v intravenski injekciji (injekciji v veno).
This document is a summary of the European Public Assessment Report (EPAR) for Kepivance.
stopnja po lestvici Svetovne zdravstvene organizacije [SZO]).
This summary was last updated in 03-2016.
Navodilo je bilo nazadnje revidirano dne
However, in the study of patients receiving chemotherapy without radiation, there was no difference in the severity of mucositis between the patients receiving placebo and those receiving either schedule of Kepivance.
V študiji za presojo potencialne kancerogenosti na transgenskih rasH miših niso opažali, da bi se incidence neoplastičnih lezij povečale v zvezi z zdravljenjem.
What is the risk associated with Kepivance?
Možno tveganje za človeški zarodek in plod ni znano.
For more information about treatment with Kepivance, read the package leaflet (also part of the EPAR).
Za informacije o pripravi in dajanju zdravila Kepivance glejte informacije za zdravstveno osebje na koncu teh navodil.
In patients receiving chemotherapy and radiotherapy, the cells are not replaced as quickly, which leads to the development of mucositis.
Hematološki malignomi nimajo eksprimiranih receptorjev KGF, toda bolnike, zdravljene s kemoterapijo in/ali radioterapijo, bolj ogrožajo sekundarni tumorji.
The full EPAR for Kepivance can be found here.
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
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
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Kepivance has been compared with placebo (a dummy treatment) in one main study in 212 adults receiving chemotherapy and radiotherapy for a blood cancer (mostly non-Hodgkin's lymphoma).
Pojavnost hudega (3. in 4. stopnje) oralnega mukozitisa v treh skupinah je bila 36,8-% v skupini s placebom, 38,3-% v skupini, ki je palifermin prejemala pred/po KT, in 23,9-% v skupini, ki je palifermin prejemala pred KT, pri tem pa ni bilo statistično značilnih razlik.
This study is still ongoing.
Ta študija še poteka.
The studies will include children below 2 years of age, for whom there are currently no data.
Študije bodo vključevale tudi otroke, mlajše od 2 let, saj zanje trenutno ni podatkov.
Brineura cerliponase alfa
Brineura cerliponaza alfa
A patient's final score was the sum of the two scores.
Bolnikova končna ocena je seštevek obeh ocen.
The treatment can continue for as long as the patient benefits from it.
Zdravljenje se nadaljuje tako dolgo, dokler je za bolnika koristno.
What measures are being taken to ensure the safe and effective use of Brineura?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Brineura?
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Brineura'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 Brineura večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It is not intended to provide practical advice on how to use Brineura.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Brineura.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Brineura.