natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 20 mg hard capsules
Fluctin Kapseln 20.mg trda kapsula peroralna uporaba
What (Invented name)® 20mg capsules contain:
Kaj vsebuje zdravilo (Izmišljeno ime)® 20 mg kapsule Zdravilna učinkovina je fluoksetinijev klorid.
NAME OF THE MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]>
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM <[Glejte Dodatek I - Dopolnjeno nacionalno]>
SPECIAL STORAGE CONDITIONS Do not store above 25˚C.
Shranjevanje pri temperaturi do 25 °C.
Pharmacodynamic properties
5.1 Farmakodinamične lastnosti
Further information on Emgality can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Emgality so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This will stop the symptoms of migraine.
To prepreči simptome migrene.
What measures are being taken to ensure the safe and effective use of Emgality?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emgality?
The European Medicines Agency therefore decided that Emgality's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Emgality večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It contains the active substance galcanezumab.
Vsebuje učinkovino galkanezumab.
Emgality (galcanezumab) EMA/658658/2018
Emgality (galkanezumab) EMA/658658/2018
Patients can inject the medicine themselves after being trained.
Bolniki si po ustreznem usposabljanju zdravilo lahko injicirajo sami.
Other information about Emgality
Druge informacije o zdravilu Emgality
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emgality 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 Emgality upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Po treh mesecih morajo zdravniki oceniti zdravljenje in z njim nadaljevati, če bolniku koristi.
As for all medicines, data on the use of Emgality are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Emgality stalno spremljajo.
The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
Najpogostejši neželeni učinki zdravila Emgality (ki se lahko pojavijo pri največ 1 bolniku od 10) so reakcije na mestu injiciranja, na primer bolečina, rdečina, srbečica, podplutba ali oteklina.
Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Emgality je zdravilo, ki se uporablja za preprečevanje migrene pri odraslih, ki imajo migreno vsaj štiri dni na mesec.
The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size.
Učinkovina zdravila Emgality, galkanezumab, je monoklonsko protitelo (vrsta beljakovine), zasnovano tako, da se veže na snov CGRP in zavre njeno delovanje ter tako pripomore, da se krvne žile vrnejo v običajno velikost.
Treatment should be started with the injection of the content of 2 syringes (or pens), followed a month later by single injections given every month.
Zdravljenje je treba začeti z injiciranjem vsebine dveh injekcijskih brizg (ali injekcijskih peresnikov), čemur mesec pozneje sledi mesečno injiciranje vsebine ene injekcijske brizge.
Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Emgality, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Emgality have been shown in studies?
Kakšne koristi je zdravilo Emgality izkazalo v študijah?
An overview of Emgality and why it is authorised in the EU
Pregled zdravila Emgality in zakaj je odobreno v EU
Why is Emgality authorised in the EU?
Zakaj je zdravilo Emgality odobreno v EU?
A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain.
Izkazalo se je, da snov, imenovana CGRP, sodeluje pri razvoju migrene, tako da širi krvne žile v možganih.
What are the risks associated with Emgality?
Kakšna tveganja so povezana z zdravilom Emgality?
For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Emgality glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What is Emgality and what is it used for?
Kaj je zdravilo Emgality in za kaj se uporablja?
Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
Zdravilo Emgality se je pri zmanjševanju števila migrenskih dni izkazalo za učinkovitejše od placeba, čeprav je učinek omejen, zlasti pri bolnikih s kroničnimi migrenami.
Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine.
Predpisovanje in izdaja zdravila Emgality je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem migrene.
Emgality is injected under the skin using a pre-filled syringe or pen.
Zdravilo Emgality se injicira pod kožo z uporabo napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika.
The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
Neželeni učinki, opaženi pri zdravilu Emgality, veljajo za obvladljive, večina je blagih ali zmernih.
In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.
V tretji študiji, v katero je bilo vključenih 1 117 bolnikov, ki so imeli migreno v povprečju več kot 15 dni na mesec (kronična migrena), so imeli bolniki, zdravljeni z zdravilom Emgality, na mesec približno pet migrenskih dni manj, bolniki, ki so jemali placebo, pa tri migrenske dneve manj.
Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
Na splošno je zdravilo Emgality povzročilo dva migrenska dneva manj na mesec v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
V dveh študijah, pri katerih je sodelovalo 1 784 bolnikov, ki so imeli migreno med štiri in 14 dni na mesec, so tisti, ki so bili zdravljeni z zdravilom Emgality, imeli štiri ali pet migrenskih dni manj na
For the full list of side effects and restrictions of Emgality, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Emgality glejte navodilo za uporabo.
How does Emgality work?
Kako zdravilo Emgality deluje?
How is Emgality used?
Kako se zdravilo Emgality uporablja?
Emgality was shown to be effective at reducing the number of days patients suffer migraines in 3 main studies.
V treh glavnih študijah je bilo dokazano, da je zdravilo Emgality učinkovito pri zmanjševanju števila migrenskih dni pri bolnikih.
This summary was last updated in 07-2007.
Povzetek je bil nazadnje posodobljen 07-2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Gliolan to m e d a c Gesellschaft für klinische Spezialpräparate mbH on 7 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom Gliolan, veljavno po vsej Evropski uniji, odobrila družbi m e d a c Gesellschaft für klinische Spezialpräparate mbH dne 7. september 2007.
However, because 5-aminolevulinic acid is a naturally occurring substance which is already used in some other conditions, the company also presented data from the published literature.
Ker pa je 5-aminolevulinska kislina snov, ki se naravno pojavlja, ter se že uporablja pri nekaterih drugih stanjih, je podjetje predstavilo tudi podatke iz objavljene literature.
Other information about Gliolan:
Druge informacije o zdravilu Gliolan:
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Which measures are being taken to ensure the safe use of Gliolan?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Gliolan?
The brain scans were analysed by an expert who did not know whether the patients had received Gliolan or not.
Slike možganov je analiziral strokovnjak, ki ni vedel, ali so bolniki prejeli zdravilo Gliolan ali ne.
The summary of opinion of the Committee for Orphan Medicinal Products for Gliolan is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Gliolan je na voljo tukaj.
It contains the active substance 5-aminolevulinic acid hydrochloride (30 mg/ml).
Vsebuje zdravilno učinkovino hidroklorid 5-aminolevulinske kisline (30 mg/ml).
The side effects seen most commonly (in more than 1 patient in 10) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leukocytosis (high levels of leukocytes, a type of white blood cell) and increased levels of liver enzymes in the blood (bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase and amylase).
Najpogostejši neželeni stranski učinki (opaženi pri več kot 1 od 10 bolnikov) so slabokrvnost (nizka koncentracija rdečih krvničk), trombocitopenija (nizka koncentracija krvnih ploščic), levkocitoza (visoka koncentracija levkocitov, vrste belih krvničk) ter povišane ravni jetrnih encimov v krvi (bilirubina, alanin-aminotransferaze, aspartataminotransferaze, gamaglutamil-transferaze in amilaze).
It is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
V telesu ga absorbirajo celice, v le-teh pa ga encimi pretvorijo v fluorescentne kemikalije, zlasti protoporfirin IX (PPIX).
The effects of Gliolan were first tested in experimental models before being studied in humans.
Učinki zdravila Gliolan so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GLIOLAN EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) GLIOLAN Povzetek EPAR za javnost
It should also not be used by patients who have porphyria (an inability to break down porphyrins) or during pregnancy.
Prav tako ga ne smejo uporabljati bolniki s porfirijo (nezmožnostjo razgradnje porfirinov) ali nosečnice.
The recommended dose of Gliolan is 20 mg per kilogram body weight, taken two to four hours before the patient is anaesthetised.
Priporočeni odmerek zdravila Gliolan je 20 mg na kilogram telesne mase, ki ga bolnik prejme dve do štiri ure pred prejemom anestezije.
Because the number of patients with malignant glioma is low, the disease is considered ‘rare', and Gliolan was designated an ‘orphan medicine' (a medicine used in rare diseases) on 13 November
Ker je število bolnikov z malignim gliomom majhno, velja ta bolezen za redko, zato je bilo zdravilo Gliolan 13. novembra 2002 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
After six months, 20.5% of the patients given Gliolan were still alive without progression, compared with 11.0% of those who did not receive the medicine.
Po šestih mesecih je bilo še živih brez napredovanja bolezni 20,5 % bolnikov, ki so prejeli zdravilo Gliolan, v primerjavi z 11 % bolnikov, ki zdravila niso prejeli.
When illuminated under blue light of a specific wavelength, the PPIX in the tumour glows an intense red, while the normal brain tissue appears blue.
Ob osvetlitvi z modro svetlobo z določeno valovno dolžino PPIX v tumorju žari intenzivno rdeče, medtem ko je normalno možgansko tkivo videti modro.
What benefit has Gliolan shown during the studies?
Kakšne koristi je zdravilo Gliolan izkazalo med raziskavami?
Before the medicine is launched, the company that makes Gliolan will set up training courses in all Member States for brain surgeons to inform them about how to use the medicine safely and effectively during surgery.
Pred pričetkom trženja zdravila bo podjetje, ki proizvaja zdravilo Gliolan, pripravilo izobraževalne tečaje za nevrokirurge v vseh državah članicah, katerih namen bo posredovanje informacij o varni in učinkoviti uporabi zdravila med operacijo.
The most common side effects seen with Gliolan are due to a combination of the medicine itself, as well as anaesthesia and the removal of the tumour.
Najpogostejši neželeni učinki, opaženi pri uporabi zdravila Gliolan, so posledica kombinacije zdravila samega, kakor tudi anestezije in odstranitve tumorja.
At 72 hours after the operation, 63.6% of the patients given Gliolan had no visible tumour on a brain scan, compared with 37.6% of those who did not receive Gliolan.
72 ur po operaciji 63,6 % bolnikov, ki so prejeli zdravilo Gliolan, ni imelo vidnega tumorja na sliki možganov, v primerjavi s 37,6 % med bolniki, ki niso prejeli zdravila Gliolan.
The outcome of the operation was compared between patients taking Gliolan (operated under blue light) and that of patients who did not take any medicines to improve the visibility of the tumour (operated under normal white light).
Primerjali so rezultate operacij pri bolnikih, ki so prejeli zdravilo Gliolan (operirani pod modro svetlobo), z rezultati operacij pri bolnikih, ki niso prejeli nikakršnega sredstva za izboljšanje vidnosti tumorja (operirani pod normalno belo svetlobo).
Gliolan should not be used in people who may be hypersensitive (allergic) to 5-aminolevulinic acid hydrochloride or porphyrins.
Zdravila Mimpara ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) hidroklorid 5-aminolevulinske kisline ali porfirine.
Since glioma cells take up more of the active substance and convert it more rapidly into PPIX, higher levels of PPIX accumulate in the cancer cells than in normal tissue.
Ker celice glioma absorbirajo več učinkovine in jo hitreje pretvorijo v PPIX, pride v rakavih celicah do višje koncentracije PPIX kot v normalnem tkivu.
Gliolan should be used with caution in patients who have problems with their liver or kidneys.
Zdravilo Gliolan je treba pri bolnikih, ki imajo težave z jetri ali ledvicami, uporabljati previdno.
It recommended that Gliolan be given marketing authorisation.
Priporočil je odobritev dovoljenja za promet z zdravilom Gliolan.
It concluded that Gliolan increases the ability of the tumour to be distinguished from healthy brain tissue during surgery, and that it increases the proportion of patients whose tumours are completely removed and extends the time that patients survive without progression.
Sklenil je, da zdravilo Gliolan poveča možnost razlikovanja med tumorjem in zdravim možganskim tkivom med operacijo ter da povečuje delež bolnikov, katerih tumorji so odstranjeni v celoti, kakor tudi podaljša čas preživetja bolnikov brez napredovanja bolezni.
The main measures of effectiveness were the proportion of patients who had no visible tumour on a brain scan taken 72 hours after the operation, and the proportion who survived six months without the brain tumour coming back or getting bigger (‘progressing').
Glavno merilo učinkovitosti sta bila delež bolnikov, ki na sliki možganov, posneti 72 ur po operaciji, ni imel vidnega tumorja, ter delež bolnikov, ki je 6 mesecev preživel brez ponovnega pojava tumorja ali njegove rasti (napredovanja).
Why has Gliolan been approved?
Zakaj je bilo zdravilo Gliolan odobreno?
For the full list of all side effects reported with Gliolan, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Gliolan, glejte Navodilo za uporabo.
What is the risk associated with Gliolan?
Kakšna tveganja so povezana z zdravilom Gliolan?
Gliolan is used in adult patients with malignant glioma (a type of brain tumour).
Zdravilo Gliolan se uporablja pri odraslih bolnikih z malignim gliomom (vrsto možganskega tumorja).
Removal of the brain tumour during surgery was more complete when Gliolan was used.
Odstranitev možganskega tumorja med operacijo je bila ob uporabi zdravila Gliolan popolnejša.
The Committee for Medicinal Products for Human Use (CHMP) noted that surgical treatment for malignant glioma should aim to remove as much of the tumour as possible while sparing healthy brain tissue.
Odbor za zdravila za uporabo v humani medicini (CHMP) je poudaril, da bi naj kirurško zdravljenje malignega glioma stremelo k odstranitvi kar se da velikega dela tumorja, vendar brez nepotrebnega odstranjevanja zdravega možganskega tkiva.
Gliolan powder should be dissolved in 50 ml tap water by a nurse or pharmacist before the patient drinks the solution.
Prašek Gliolan mora medicinska sestra ali farmacevt raztopiti v 50 ml pitne vode, tako dobljeno raztopino pa bolnik popije.
The active substance in Gliolan, 5-aminolevulinic acid, is a ‘sensitiser used in photodynamic therapy'.
Zdravilna učinkovina v zdravilu Gliolan, 5-aminolevulinska kislina, je pripravek, namenjen uporabi pri fotodinamični terapiji.
Gliolan has been studied in one main study involving 415 patients with malignant glioma who were about to undergo brain surgery to remove the tumour.
Zdravilo Gliolan so preučevali v okviru ene glavne študije, ki je vključevala 415 bolnikov z malignim gliomom, pri katerih bi naj izvedli operacijo možganov z namenom odstranitve tumorja.
Gliolan should only be used by experienced brain surgeons who are familiar with surgery of malignant glioma, who have an in-depth knowledge of the anatomy of the brain, and who have completed a training course in surgery guided by fluorescence.
Zdravilo smejo uporabljati samo nevrokirurgi z izkušnjami pri operacijah malignih gliomov in s poglobljenim znanjem anatomije možganov, ki so zaključili tečaj iz opravljanja kirurških posegov, vodenih s fluorescenco.
The Committee decided that Gliolan's benefits are greater than its risks for the visualisation of malignant tissue during surgery for malignant glioma.
Odbor je sklenil, da so koristi zdravila Gliolan za vizualizacijo malignega tkiva med operacijo malignega glioma večje od z njim povezanih tveganj.
This enables the surgeon to see the tumour more clearly during brain surgery and to remove it more accurately, sparing healthy brain tissue.
To zagotavlja kirurgu med operacijo boljšo vidnost tumorja in s tem njegovo natančnejšo odstranitev, brez nepotrebnega odstranjevanja zdravega možganskega tkiva.
What is Gliolan used for?
Za kaj se zdravilo Gliolan uporablja?
How has Gliolan been studied?
Kako je bilo zdravilo Gliolan raziskano?
Gliolan helps surgeons to see the tumour more clearly during an operation to remove it from the brain.
Zdravilo Gliolan omogoča kirurgom med operacijo boljšo vidnost tumorja in s tem njegovo odstranitev iz možganov.
How does Gliolan work?
Kako zdravilo Gliolan deluje?
What is Gliolan?
Kaj je zdravilo Gliolan?
Gliolan is a powder to be made up into a solution to be taken by mouth.
Zdravilo Gliolan je prašek, namenjen za pripravo peroralne raztopine (ki se daje skozi usta).
How is Gliolan used?
Kako se zdravilo Gliolan uporablja?
The full EPAR for Gliolan can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Gliolan je na voljo tukaj.
‘Invasive' means that the infection has spread into the blood;
„Invazivna“ pomeni, da se je okužba razširila v kri;
It is given once a day by infusion lasting about one hour.
Zdravilo se daje enkrat dnevno v obliki počasne infuzije, ki traja približno eno uro.
The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001.
Evropska komisija je dovoljenje za promet z zdravilom Caspofungin MSD, veljavno po vsej Evropski uniji, izdala 24. oktobra 2001.
What measures are being taken to ensure the safe and effective use of Cancidas?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cancidas?
This is known as ‘empirical treatment', which means that the doctor starts treatment based on an observation of the patient before confirming that the patient has the infection.
Temu pravimo „empirično zdravljenje“, kar pomeni, da se zdravljenje začne na podlagi opazovanja bolnika, preden lahko zdravnik potrdi, da je bolnik okužen.
The name of the medicine was changed to Cancidas on 9 April
Ime zdravila je bilo 9. aprila 2003 spremenjeno v Cancidas.
The full EPAR for Cancidas 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 Cancidas je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cancidas should be used with care in children below 12 months of age, because it has not been studied sufficiently in this age group.
Zdravilo Cancidas je treba pri otrocih, mlajših od 12 mesecev, uporabljati previdno, saj zdravilo v tej starostni skupini ni bilo zadostno raziskano.
Other information about Cancidas
Druge informacije o zdravilu Cancidas
This is a summary of the European public assessment report (EPAR) for Cancidas.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cancidas.
The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood.
Najpogostejši neželeni učinki zdravila Cancidas pri odraslih (ki lahko prizadenejo največ 1 osebo od 10) so zmanjšana raven hemoglobina ali rdečih krvnih celic, zmanjšano število belih krvnih celic, nizka raven kalija v krvi, glavobol, vnetje ven, težave pri dihanju, navzeja, driska, bruhanje, povišane ravni jetrnih encimov in bilirubina (kar lahko kaže na težave z jetri), izpuščaj, srbenje, pordelost kože, čezmerno znojenje, bolečina v sklepih, povišana telesna temperatura, mrzlica, srbenje na mestu injiciranja in zmanjšane ravni albumina (beljakovine v krvi).
In patients between 12 months and 17 years of age, the dose is calculated using the child's height and weight.
Pri bolnikih, starih od 12 mesecev do 17 let, se odmerek izračuna na podlagi otrokove višine in telesne mase.
It is not intended to provide practical advice on how to use Cancidas.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow.
Celice gliv, ki so izpostavljene zdravilu Cancidas, imajo nepopolne ali okvarjene celične stene, zaradi česar so občutljive in ne morejo rasti.
Treatment is continued for up to two weeks after the infection has been cured.
Ko je okužba pozdravljena, se zdravljenje nadaljuje še do dva tedna.