natgillin/translations-raw huggingface dataset:
Mylotarg is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Mylotarg je prašek za pripravo raztopine za infundiranje (dajanje v veno).
How is Mylotarg expected to work?
Kako naj bi zdravilo Mylotarg delovalo?
The active substance in Mylotarg, gemtuzumab ozogamicin, is a cytotoxic (cell-killing) substance that is linked to a monoclonal antibody.
Gemtuzumab ozogamicin, zdravilna učinkovina v zdravilu Mylotarg, je citotoksična učinkovina (učinkovina, ki ubija celice), ki je vezana na monoklonsko protitelo.
Complete remission is when the leukaemia cells can no longer be detected in the blood and are at very low levels in the bone marrow.
O popolni remisiji govorimo, ko v krvi celic levkemije ni več
The monoclonal antibody part of the active substance (gemtuzumab) has been designed to bind to CD33, an antigen which is found on the surface of acute myeloid leukaemia cells in about 80% of patients.
antigen, ki ga pri približno 80 % bolnikov najdemo na površini celic akutne mieloične levkemije.
The study was then extended to four years.
Študija je bila nato podaljšana na štiri leta.
All patients should be assessed at least once every two years.
Vse bolnike je treba oceniti vsaj enkrat na dve leti.
Further information on Rebif can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rebif.
Nadaljnje informacije za zdravilo Rebif so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/rebif.
Other information about Rebif
Druge informacije o zdravilu Rebif
What measures are being taken to ensure the safe and effective use of Rebif?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rebif?
The European Medicines Agency decided that Rebif's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Rebif večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The patients had experienced at least two relapses in the previous two years.
Bolniki so imeli vsaj dva zagona v preteklih dveh letih.
Rebif received a marketing authorisation valid throughout the EU on 4 May 1998.
Za zdravilo Rebif je bilo 4. maja 1998 izdano dovoljenje za promet, veljavno po vsej EU.
As for all medicines, data on the use of Rebif are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rebif stalno spremljajo.
Some effect on progression of disability could be seen, but only in the patients who had relapses in the two years before the start of the study.
Opaziti je mogoče določen učinek na napredovanje invalidnosti, vendar le pri bolnikih, ki so imeli zagone v dveh letih pred začetkom študije.
What benefits of Rebif have been shown in studies?
Kakšne koristi zdravila Rebif so se pokazale v študijah?
Side effects reported with Rebif are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Rebif, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Rebif?
Kakšna tveganja so povezana z zdravilom Rebif?
Why is Rebif authorised in the EU?
Zakaj je bilo zdravilo Rebif odobreno v EU?
When first starting treatment with Rebif, the dose should be slowly increased from a starting dose of 8.8 micrograms three times a week to avoid side effects.
Po prvi uvedbi zdravljenja z zdravilom Rebif je treba odmerek počasi povečati od začetnega odmerka 8,8 mikrograma trikrat na teden, da se preprečijo neželeni učinki.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rebif have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rebif upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Rebif and why it is authorised in the EU
Pregled zdravila Rebif in zakaj je odobreno v EU
The probability of developing MS over 24 months was 62.5% for patients given Rebif three times a week and 75.5% for patients given Rebif once a week compared with 85.8% for patients given placebo.
Verjetnost razvoja multiple skleroze v 24 mesecih je bila 62,5 % pri bolnikih, ki so prejemali zdravilo Rebif trikrat na teden, in 75,5 % pri bolnikih, ki so prejemali zdravilo Rebif enkrat na teden, v primerjavi s 85,8 % pri bolnikih, ki so prejemali placebo.
What is Rebif and what is it used for?
Kaj je zdravilo Rebif in za kaj se uporablja?
For more information about using Rebif, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Rebif glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Rebif (which may affect more than 1 in 10 people) are flu-like symptoms, neutropenia, lymphopenia and leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, inflammation and other reactions at the injection site, and increases in transaminases (liver enzymes).
Najpogostejši neželeni učinki zdravila Rebif (ki se lahko pojavijo pri več kot 1 od 10 oseb) so gripi podobni simptomi, nevtropenija, limfopenija in levkopenija (nizko število belih krvnih celic), trombocitopenija (nizko število trombocitov v krvi), anemija (nizko število rdečih krvnih celic), glavobol, vnetje in druge reakcije na mestu injiciranja ter povečanja vrednosti transaminaz (jetrnih encimov).
A 22-microgram dose is recommended for patients who cannot tolerate the higher dose.
Pri bolnikih, ki ne morejo prenašati višjega odmerka, je priporočen 22-mikrogramski odmerek.
Rebif (44 micrograms given once or three times a week) has also been compared with placebo in 515 patients who had experienced a single attack of demyelination.
Zdravilo Rebif (44 mikrogramov, ki so ga dajali enkrat ali trikrat na teden) so primerjali tudi s placebom pri 515 bolnikih, ki so imeli samo en napad demielinizacije.
The doctor may advise the patient to take a fever-reducing painkiller before each injection and for 24 hours after injection to reduce the influenza (flu)-like symptoms that may occur as a side effect of treatment.
Zdravnik lahko svetuje bolniku, naj pred vsakim injiciranjem in v 24 urah po injiciranju vzame protibolečinsko zdravilo za zniževanje povišane telesne temperature, da se zmanjšajo gripi podobni simptomi, ki bi se lahko pojavili kot neželeni učinek zdravljenja.
Rebif must not be used in patients who have severe depression or have thoughts of suicide.
Zdravilo Rebif se ne sme uporabljati pri bolnikih s hudo depresijo in/ali samomorilnimi mislimi.
The recommended dose of Rebif is 44 micrograms given three times a week by injection under the skin.
Priporočeni odmerek zdravila Rebif je 44 mikrogramov, ki se daje trikrat na teden z injiciranjem v podkožje.
The active substance in Rebif is the protein interferon beta-1a, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Učinkovina v zdravilu Rebif je beljakovina interferon beta-1a, ki je ena od skupin interferonov, ki jih lahko telo naravno ustvari v boju proti virusom in drugim napadom.
Rebif is available as a solution for injection in prefilled syringes, prefilled pens and cartridges for use in an electronic injection device.
Zdravilo Rebif je na voljo kot raztopina za injiciranje v napolnjenih injekcijskih brizgah, napolnjenih injekcijskih peresnikih ali vložkih za uporabo z elektronskim pripomočkom za injiciranje.
Rebif can also be used in patients who have had a single attack of demyelination accompanied by inflammation.
Zdravilo Rebif se lahko uporablja tudi pri bolnikih, ki so imeli samo en napad demielinizacije, ki ga je spremljalo vnetje.
Rebif is a medicine used to treat patients with relapsing multiple sclerosis (MS).
Rebif je zdravilo, ki se uporablja za zdravljenje bolnikov z multiplo sklerozo (MS) z zagoni.
The exact way that Rebif works in MS is not yet known but the active substance, interferon beta-1a, seems to calm down the immune system, and prevents relapses of MS.
Natančen način delovanja zdravila Rebif pri multipli sklerozi še ni znan, vendar se zdi, da učinkovina, interferon beta-1a, pomirja imunski sistem in preprečuje zagone multiple skleroze.
For the full list of side effects and restrictions with Rebif, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Rebif glejte navodilo za uporabo.
Patients received either Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years.
Bolniki so dve leti prejemali bodisi zdravilo Rebif (v odmerku 22 ali 44 mikrogramov) ali placebo (zdravilo brez učinkovine).
Rebif was more effective than placebo in reducing the number of relapses in relapsing MS. Relapses were reduced by about 30% over two years for both Rebif 22 and 44 micrograms compared with placebo, and by 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over four years.
Število zagonov se je v dveh letih zmanjšalo za približno 30 % ob jemanju zdravila Rebif v odmerkih 22 in 44 mikrogramov v primerjavi s placebom, in za 22 % (z zdravilom Rebif v odmerku 22 mikrogramov) in za 29 % (z zdravilom Rebif v odmerku 44 mikrogramov) v štirih letih.
Rebif's effectiveness has not been shown in patients with secondary progressive MS (the type of MS that comes after relapsing MS) that is not relapsing.
Učinkovitost zdravila Rebif ni bila dokazana pri bolnikih s sekundarno progresivno multiplo sklerozo (vrsto multiple skleroze, ki sledi tisti z zagoni), ki nimajo zagonov.
How is Rebif used?
Kako se zdravilo Rebif uporablja?
The patients can inject Rebif themselves once they have been trained.
Bolniki si lahko po ustreznem usposabljanju zdravilo Rebif injicirajo sami.
Rebif contains the active substance interferon beta-1a.
Zdravilo Rebif vsebuje učinkovino interferon beta-1a.
Rebif can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of MS.
Predpisovanje in izdaja zdravila Rebif je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
Rebif has been studied in 560 patients with relapsing MS.
Zdravilo Rebif so raziskovali pri 560 bolnikih z multiplo sklerozo z zagoni.
How does Rebif work?
Kako zdravilo Rebif deluje?
It is used when the patient is considered to be at high risk of developing MS. Before using Rebif, doctors need to exclude other causes for the symptoms.
Pred uporabo zdravila Rebif morajo zdravniki izključiti druge možne vzroke za simptome.
Relapsing MS is the type of MS where the patient has attacks (relapses) between periods with no symptoms.
Multipla skleroza z zagoni je vrsta multiple skleroze, pri kateri ima bolnik napade (zagone) med obdobji brez simptomov.
Rebif has also been studied in patients with secondary progressive MS. Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Zdravilo ni bistveno vplivalo na napredovanje invalidnosti, stopnja zagonov pa se je znižala za približno 30 %.
3 x 30 tablets (multipack)
3 x 30 tablet (pakiranje po več enot)
In addition, the Committee was of the opinion that more information was needed about how the medicine is absorbed, modified and removed from the body.
Poleg tega je bil odbor mnenja, da je potrebnih več informacij o absorpciji in modifikaciji zdravila ter njegovem odstranjevanju iz telesa.
The main measure of effectiveness was improvement in vision.
Glavno merilo učinkovitosti je bilo izboljšanje vida.
Progressive means that symptoms get steadily worse over time.
Progresivna oblika pomeni, da se simptomi sčasoma vztrajno slabšajo.
Symptoms include weakness, difficulty walking and problems with vision.
Simptomi vključujejo oslabelost, težave s hojo in vidom.
Qizenday is a medicine that contains the active substance biotin.
Qizenday je zdravilo, ki vsebuje zdravilno učinkovino biotin.
Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
Trije od teh encimov so vključeni v proizvodnjo energije, četrti pa naj bi bil vključen v tvorbo ovojnic okrog živčnih celic.
Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
Umik vloge za pridobitev dovoljenja za promet z zdravilom Qizenday (biotin) EMA/821654/2017
The second study involved 93 patients with multiple sclerosis who had visual loss due to inflammation of the optic nerve.
V drugo študijo je bilo vključenih 93 bolnikov z multiplo sklerozo, pri katerih je prišlo do izgube vida zaradi vnetja vidnega živca.
The mechanism of action of Qizenday in multiple sclerosis is not well understood; however, it is thought that the medicine acts on enzymes (known as carboxylases) to increase energy production in the damaged nerves and to help repair the protective sheath around the nerve cells.
Mehanizem delovanja zdravila Qizenday pri multipli sklerozi ni dobro znan; vendar pa se domneva, da zdravilo deluje na encime (znane kot karboksilaze), s čimer poveča proizvodnjo energije v poškodovanih živcih in pomaga popravljati zaščitno ovojnico okrog živčnih celic.
The first study involved 154 patients with spinal progressive multiple sclerosis.
V prvo študijo je bilo vključenih 154 bolnikov s progresivno
measure of effectiveness was the number of patients whose overall disability decreased and whose ability to walk improved.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je skupna prizadetost sčasoma zmanjšala in zmožnost hoje izboljšala.
The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment).
Družba je predstavila podatke dveh glavnih študij, v katerih so zdravilo Qizenday primerjali s placebom (zdravilom brez zdravilne učinkovine).
Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate.
Zdravilo Qizenday naj bi se uporabljalo za zdravljenje odraslih s progresivno obliko multiple skleroze, bolezni, pri kateri pride do poškodbe zaščitne ovojnice okrog živčnih celic v možganih in hrbtenjači, živci pa postopoma degenerirajo.
On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.
Družba Medday Pharmaceuticals je 13. novembra 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Qizenday, namenjenim zdravljenju progresivne multiple skleroze.
Withdrawal of the marketing authorisation application for Qizenday (biotin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Qizenday (biotin)
What is Qizenday?
Kaj je zdravilo Qizenday?
How does Qizenday work?
Kako zdravilo Qizenday deluje?
The CHMP considered that the data on the medicine's effectiveness were not robust enough, and that there were uncertainties regarding the medicine's safety given the small number of patients treated with Qizenday.
Odbor CHMP je presodil, da podatki o učinkovitosti zdravila niso dovolj zanesljivi in da zaradi majhnega števila bolnikov, zdravljenih z zdravilom Qizenday, obstajajo nejasnosti o njegovi varnosti.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Qizenday.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Qizenday.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umik temelji na mnenju CHMP, da predstavljeni klinični podatki odboru ne dovoljujejo, da bi pozitivno ocenil razmerje med tveganji in koristmi zdravila Qizenday.
What was Qizenday expected to be used for?
Za kaj naj bi se zdravilo Qizenday uporabljalo?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qizenday did not outweigh its risks.
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Qizenday ne odtehtajo z njim povezanih tveganj.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis.
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Qizenday ni mogoče odobriti za zdravljenje progresivne multiple skleroze.
These checks may include:
Te preiskave lahko vključujejo:
31-January-2022
31. januar 2022.
• you have fainted recently
• ste pred nedavnim omedleli;
Date of first authorisation: 17/09/2015
Datum prve odobritve: 17. september 2015
Adolescent subjects must weigh at least 34 kg.
Mladostniki morajo tehtati vsaj 34 kg.
They can find it hard to behave well at home, at school or in other places.
Težko se lepo vedejo doma, v šoli in drugod.
Not known (cannot be estimated from the available data).
neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This is because this medicine can make these problems worse.
To zdravilo namreč lahko poslabša te težave.
ADHD can cause problems with everyday life.
ADHD lahko povzroča težave v vsakdanjem življenju.
It is recommended clinical judgement be exercised during this period.
Priporočljivo je, da v tem obdobju uporabljate klinično presojo.
• concentrate.
• se osredotočijo.
Children under 6 years
Otroci, mlajši od 6 let
Submission of final study Report:
Predložitev končnega poročila študije:
This will show if you still need to take the medicine.
Tako se bo izkazalo, ali morate zdravilo jemati še naprej.
• This medicine should be taken once a day either in the morning or evening.
• To zdravilo je treba jemati enkrat na dan, bodisi zjutraj bodisi zvečer.
• seeing or hearing things that are not there (hallucination).
• vidite ali slišite stvari, ki jih v resnici ni (halucinacija).
Take the medicine pack with you and tell them how much you have taken.
Vzemite ovojnino zdravila s seboj in jim povejte, koliko zdravila ste vzeli.
These small changes are not expected to be clinically meaningful.
Ni pričakovati, da so te majhne spremembe klinično pomembne.
ADHD does not affect the intelligence of a child or young person.
ADHD ne vpliva na inteligentnost otroka ali mlade osebe.
Tel + 44 (0) 1256 894 959 e-mail medinfoEMEA@shire.com
Tel + 44 (0) 1256 894 959 e-pošta medinfoEMEA@shire.com
• This leaflet has been written as though the person taking the medicine is reading it.
• To navodilo je napisano, kot da ga bo brala oseba, ki jemlje zdravilo.
This medicine belongs to a group of medicines which affects brain activity.
To zdravilo spada v skupino zdravil, ki vplivajo na aktivnost možganov.
Your doctor may want to review your treatment.
Zdravnik bo mogoče želel spet pretehtati vaše zdravljenje.
If you are giving this medicine to your child, please replace “you” with “your child” throughout.
Če dajete to zdravilo svojemu otroku, po vsem navodilu zamenjajte besedico “vi” z besedama “vaš otrok”.
This medicine can help improve your attention, concentration and make you less impulsive and hyperactive.
To zdravilo vam lahko pomaga izboljšati pozornost in koncentracijo in vas narediti manj nepremišljenega in hiperaktivnega.
Syncope has also been observed.
Opazili so tudi sinkopo.
People with ADHD find it hard to:
Ljudje z ADHD težko:
Summary of primary efficacy for study SPD503-316: ADHD-RS-IV
Povzetek primarne učinkovitosti za študijo SPD503-316: ADHD-RS-IV
If you forget a dose, wait until the next day and take your usual dose.
Če pozabite vzeti odmerek, počakajte do drugega dne in takrat vzemite običajni odmerek.
Therefore, a risk on the breast-fed infant cannot be excluded.
Zato tveganja za dojenčka ne moremo izključiti.
• Do not take this medicine if you are pregnant or you are not using contraception.
• Ne jemljite tega zdravila, če ste noseči ali če ne uporabljate kontracepcije.
The Educational material and Prescriber checklist shall contain the following key messages:
Izobraževalno gradivo in kontrolni seznam za predpisovanje zdravila morata vsebovati naslednja ključna sporočila:
Formal pharmacokinetic studies for race have not been conducted.
Formalnih farmakokinetičnih študij za rase niso izvedli.
• Educational material (including prescriber checklist) for the healthcare professionals
• izobraževalno gradivo (vključno s kontrolnim seznamom za predpisovanje) za zdravstvene delavce.
Results of the secondary endpoints were consistent with that of the primary endpoint.
Rezultati sekundarnih končnih stanj so se ujemali z rezultati primarnega končnega stanja.
Activated charcoal may be useful in limiting the absorption.
Za zmanjševanje absorpcije je lahko koristno aktivno oglje.
Children and young people with ADHD may have difficulty learning and doing homework.
Otroci in mladi ljudje z ADHD se včasih težko učijo in delajo domače naloge.
Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible change in the ADHD treatment programme.
Mogoče bo potrebno zdravljenje osnovne psihiatrične bolezni, pretehtati pa je treba tudi možnost spremembe programa zdravljenja ADHD.
Treatment is recommended only for children who are able to swallow the tablet whole without problems.
Zdravljenje priporočajo le za otroke, ki lahko brez težav pogoltnejo tableto celo.
Before you start taking this medicine your doctor will check to make sure this medicine is safe for you and that it will help you.
Preden boste začeli jemati to zdravilo, bo vaš zdravnik preveril, da se bo prepričal, ali je to zdravilo za vas varno in ali vam bo pomagalo.
Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.
Zdravilo Intuniv se mora uporabljati kot del vsestranskega programa zdravljenja ADHD, ki praviloma vključuje psihološke, edukacijske in socialne ukrepe.
• you are allergic to guanfacine or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na gvanfacin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Patients should be advised to drink plenty of fluid.
Bolnikom je treba svetovati, naj uživajo veliko tekočine.
The blisters are contained in cardboard cartons.
Pretisni omoti so shranjeni v kartonskih škatlah.
Intuniv with food, drinks and alcohol
Zdravilo Intuniv skupaj s hrano, pijačo in alkoholom
Due to variability in interaction effect, further dose titration may be needed (see above).
Zaradi variabilnosti učinka interakcije bo mogoče potrebno nadaljnje titriranje odmerka (glejte zgoraj).
Guanfacine is not dialysable in clinically significant amounts (2.4%).
Gvanfacin se ne dializira v klinično pomembnih količinah (2,4 %).
• sleeping more than normal (hypersomnia)
• spite več, kot je normalno (hipersomnija),
The medicine is given as part of a treatment programme, which usually includes the following:
Zdravilo se uporablja v okviru terapevtskega programa, ki navadno vključuje:
Depending on how you respond to treatment your doctor may increase your dose more slowly.
Odvisno od vašega odziva na zdravljenje vam lahko zdravnik zvečuje odmerek še počasneje.