FrancophonIA/ELRC3.0 huggingface dataset:
English: Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Slovenian: Zdravilo Gutal je generično zdravilo za uporabo v veterinarski medicini, ki temelji na referenčnem zdravilu ZincoTec Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, ki je odobreno v Združenem kraljestvu.
English: The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Slovenian: Zdravilo je namenjeno preprečevanju driske pri prašičkih po odstavitvi.
English: Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Slovenian: Zato je priporočil, naj se v informacije o zdravilu vključi več ukrepov za zmanjšanje tveganja, ki naj bi zmanjšali kopičenje cinka v okolju.
English: The active substance of Gutal is zinc oxide.
Slovenian: Zdravilna učinkovina v zdravilu Gutal je cinkov oksid.
English: Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
Slovenian: Družba Huvepharma NV je v Združenem kraljestvu predložila vlogo za pridobitev dovoljenja za promet z zdravilom Gutal po decentraliziranem postopku.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se za zdravilo Gutal lahko izda dovoljenje za promet z zdravilom, če se v informacije o zdravilu vključijo priporočeni ukrepi za zmanjšanje tveganja, za katere se pričakuje, da bodo zmanjšali kopičenje cinka v okolju.
English: What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Slovenian: Kaj je zdravilo Gutal 1 000 g/kg predmešanica za zdravilno krmno mešanico za prašičke?
English: Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Slovenian: Zakaj je bilo zdravilo Gutal 1 000 g/kg predmešanica za zdravilno krmno mešanico za prašičke pregledano?
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but given in a different way.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje isto zdravilno učinkovino, vendar se jemlje na drugačen način.
English: EPAR summary for the public granisetron
Slovenian: Povzetek EPAR za javnost granisetron
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sancuso on 20 April 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sancuso, veljavno po vsej Evropski uniji, odobrila dne 20. aprila 2012.
English: Each patch releases 3.1 mg of granisetron over 24 hours.
Slovenian: Vsak obliž sprosti 3,1 mg granisetrona v 24 urah.
English: The full EPAR for Sancuso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Sancuso je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The majority of adverse reactions were mild or moderate in severity.
Slovenian: Večina neželenih reakcij je bila blaga ali zmerna.
English: The main measure of effectiveness was the number of patients who had their nausea and vomiting under control.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bil vzpostavljen nadzor nad slabostjo in bruhanjem.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Slovenian: To pomeni, da kemični snovi v telesu, imenovani 5- hidroksitriptamin (5HT, znani tudi kot serotonin) prepreči vezavo na receptorje 5HT3 v črevesju.
English: This is a summary of the European public assessment report (EPAR) for Sancuso.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sancuso.
English: Other information about Sancuso
Slovenian: Druge informacije o zdravilu Sancuso
English: One transdermal patch is applied 24 to 48 hours before chemotherapy.
Slovenian: En transdermalni obliž se namesti 24 do 48 ur pred kemoterapijo.
English: Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).
Slovenian: Transdermalni obliž Sancuso je izkazal podobne učinke pri preprečevanju bruhanja in slabosti po kemoterapiji kot granisetron, dajan peroralno: pri 60,2 % bolnikov, ki so prejeli transdermalni obliž Sancuso (171 od 284 bolnikov), je bila vzpostavljen nadzor nad slabostjo in bruhanjem, v primerjavi s 64,8 % bolnikov, ki so jemali granisetron peroralno (193 od 298 bolnikov).
English: For more information about treatment with Sancuso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sancuso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The patch is applied to dry, clean, healthy skin on the outer part of the upper arm or if this is not possible, it may be applied to the abdomen.
Slovenian: Obliž se namesti na suho, čisto, zdravo kožo na zunanji del nadlakti; če to ni mogoče, se obliž lahko namesti na trebuh.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Slovenian: Kadar se veže na te receptorje, 5HT običajno povzroči slabost in bruhanje.
English: By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Slovenian: Z zaviranjem teh receptorjev zdravilo Sancuso prepreči slabost in bruhanje, ki pogosto nastopita po nekaterih vrstah kemoterapije.
English: The patch can remain on the skin for up to seven days depending on the duration of the chemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy.
Slovenian: Obliž lahko ostane na koži do sedem dni, odvisno od trajanja kemoterapije, odstrani pa se ga vsaj 24 ur po dokončanju kemoterapije.
English: It is available as a transdermal patch (a patch that delivers a medicine across the skin).
Slovenian: Na voljo je v obliki transdermalnega obliža (obliža, ki dovaja zdravilo prek kože).
English: The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation.
Slovenian: Najpogostejši neželeni učinek zdravila Sancuso (opažen pri 1 do 10 bolnikih od 100) je zaprtje.
English: The benefit of Sancuso in the prevention of nausea and vomiting caused by chemotherapy was investigated in one main study involving a total of 641 patients.
Slovenian: Koristi zdravila Sancuso pri preprečevanju slabosti in bruhanja, ki ju povzroča kemoterapija, so proučevali v eni glavni študiji s skupno 641 bolniki.
English: Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.
Slovenian: Ker je zdravilo Sancuso hibridno generično zdravilo, je predlagatelj poleg rezultatov svojih lastnih študij predložil primerjalne podatke o referenčnem zdravilu.
English: Sancuso is only used in adults who would have difficulty swallowing medicines and when the chemotherapy lasts from three to five days.
Slovenian: Zdravilo Sancuso se uporablja samo pri odraslih, ki bi zdravila težko pogoltnili, in kadar traja kemoterapija od tri do pet dni.
English: What benefit has Sancuso shown during the studies?
Slovenian: Kakšne koristi je zdravilo Sancuso izkazalo med študijami?
English: Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
Slovenian: Zdravila Sancuso ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) granisetron, druge antagoniste 5HT3 ali katero koli drugo sestavino zdravila.
English: It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Slovenian: Uporablja se za preprečevanje slabosti in bruhanja, ki ju povzročajo vrste kemoterapije (zdravila, ki se uporabljajo za zdravljenje raka), ki so zmerne ali močne povzročiteljice slabosti in bruhanja.
English: This was defined as having no vomiting or retching (strong involuntary contractions of the stomach with the urge to vomit), no more than mild nausea and no need to take other anti-emetic medicines for quick relief after receiving chemotherapy.
Slovenian: Ta nadzor je pomenil: nobenega bruhanja ali spahovanja (močnih neželenih krčev želodca s potrebo po bruhanju), morda blaga slabost in nobene potrebe po drugih antiemetikih za hitro olajšanje po prejeti kemoterapiji.
English: Sancuso is a ‘hybrid generic medicine'.
Slovenian: Zdravilo Sancuso je „hibridno generično zdravilo“.
English: 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 Sancuso.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Sancuso, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections.
Slovenian: Vendar pa je CHMP menil, da bi imelo zdravilo Sancuso koristi za bolnike, ki imajo težave pri požiranju in bi sicer morali prejemati dnevne intravenske injekcije.
English: The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Slovenian: Zdravilna učinkovina zdravila Sancuso, granisetron, je „antagonist 5HT3“.
English: Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zato zaključil, da so koristi zdravila Sancuso večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What is the risk associated with Sancuso?
Slovenian: Kakšna tveganja so povezana z zdravilom Sancuso?
English: The study compared one Sancuso transdermal patch worn over seven days with granisetron taken by mouth once a day for the duration of the chemotherapy.
Slovenian: V študiji so primerjali en transdermalni obliž Sancuso, ki je bil nameščen sedem dni, z granisetronom, dajanim peroralno enkrat dnevno v času trajanja kemoterapije.
English: Sancuso is a medicine that contains the active substance granisetron.
Slovenian: Sancuso je zdravilo, ki vsebuje zdravilno učinkovino granisetron.
English: These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days.
Slovenian: Ti bolniki so nekaj dni prejemali kemoterapijo, ki je zmerna ali močna povzročiteljica slabosti in bruhanja.
English: The Committee considered that Sancuso transdermal patch showed a similar benefit to granisetron taken by mouth but that it may have a slower onset of action.
Slovenian: Odbor je menil, da je transdermalni obliž Sancuso izkazal podobne koristi kot granisetron, dajan peroralno, vendar ima lahko počasnejši začetek delovanja.
English: Why has Sancuso been approved?
Slovenian: Zakaj je bilo zdravilo Sancuso odobreno?
English: For the full list of all side effects reported with Sancuso, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sancuso, glejte navodilo za uporabo.
English: While the reference medicine for Sancuso is Kytril taken by mouth, Sancuso is a patch applied to the skin.
Slovenian: Zdravilo Kytril, ki je referenčno zdravilo zdravila Sancuso, se jemlje peroralno, zdravilo Sancuso pa se daje v obliki obliža, ki se namesti na kožo.
English: Sancuso is an ‘anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting.
Slovenian: Zdravilo Sancuso je antiemetik, tj. zdravilo, ki preprečuje slabost in bruhanje.
English: What is Sancuso used for?
Slovenian: Za kaj se zdravilo Sancuso uporablja?
English: How has Sancuso been studied?
Slovenian: Kako je bilo zdravilo Sancuso raziskano?
English: What is Sancuso?
Slovenian: Kaj je zdravilo Sancuso?
English: How does Sancuso work?
Slovenian: Kako zdravilo Sancuso deluje?
English: How is Sancuso used?
Slovenian: Kako se zdravilo Sancuso uporablja?
English: Package size l t o r
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja o ā
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
English: In addition, the company will ensure that the medicine is only provided from approved centres.
Slovenian: Podjetje bo prav tako zagotovilo, da se zdravilo daje samo v odobrenih zdravstvenih centrih.
English: However, measures are in place to monitor such events through a registry of patients and a long-term study to assess patients' long-term outcomes.
Slovenian: Vendar so bili vzpostavljeni ukrepi za spremljanje takih dogodkov s pomočjo registra bolnikov in dolgoročne študije za oceno dolgoročnega napredka.
English: What measures are being taken to ensure the safe and effective use of Zynteglo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zynteglo?
English: Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Slovenian: Nadaljnje informacije o zdravilu Zynteglo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zynteglo.
English: As a result, these patients have low red blood cell levels and need frequent blood transfusions.
Slovenian: Zato imajo ti bolniki nizke ravni rdečih krvnih celic in potrebujejo pogoste transfuzije krvi.
English: Although information on the safety of the medicine is limited because of the small number of patients treated to date and the lack of long-term data, the European Medicines Agency decided that Zynteglo's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Čeprav so informacije o varnosti zdravila omejene zaradi majhnega števila zdravljenih bolnikov doslej in pomanjkanja dolgoročnih podatkov, je Evropska agencija za zdravila zaključila, da so koristi zdravila Zynteglo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Patients will also receive a guide and a card that they should carry with them.
Slovenian: Bolniki bodo prejeli tudi vodnik in opozorilno kartico, ki jo morajo imeti vedno pri sebi.
English: An overview of Zynteglo and why it is authorised in the EU
Slovenian: Pregled zdravila Zynteglo in zakaj je odobreno v EU
English: This means that the patients can avoid the excessive build-up of iron that occurs with regular transfusions and which itself requires treatment.
Slovenian: To pomeni, da se lahko bolniki izognejo prenasičenosti z železom, ki nastane zaradi kroničnih transfuzij in ki sama po sebi zahteva zdravljenje.
English: Regarding safety, because Zynteglo is produced using a virus, there could be a theoretical risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Slovenian: Ker se zdravilo Zynteglo izdela s pomočjo virusa, obstaja z vidika varnosti teoretično tveganje za nastanek raka zaradi nenačrtovanih sprememb genskega materiala, čeprav do zdaj tovrstnih primerov niso opazili.
English: There is also a potential risk of bleeding since the medicine may cause a drop in platelets.
Slovenian: Poleg tega obstaja možno tveganje za krvavitve, saj lahko zdravilo povzroči padec ravni trombocitov.
English: As for all medicines, data on the use of Zynteglo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zynteglo stalno spremljajo.
English: Other information about Zynteglo
Slovenian: Druge informacije o zdravilu Zynteglo
English: Why is Zynteglo authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Zynteglo odobreno v EU?
English: The company that markets Zynteglo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risks of cancer and bleeding, and how it should be given.
Slovenian: Podjetje, ki trži zdravilo Zynteglo, bo priskrbelo izobraževalno gradivo za zdravstvene delavce, ki naj bi uporabljali zdravilo, ki bo vsebovalo informacije o njegovi varnosti, vključno z morebitnimi tveganji za nastanek raka in krvavitev, in načinu njegovega dajanja.
English: Side effects reported with Zynteglo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Zynteglo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Zynteglo and what is it used for?
Slovenian: Kaj je zdravilo Zynteglo in za kaj se uporablja?
English: Doctors should consider whether patients can be given the required pre-treatments needed before Zynteglo.
Slovenian: Zdravniki morajo proučiti, ali lahko bolniki pred zdravljenjem z zdravilom Zynteglo prejmejo predhodno pripravljalno zdravljenje.
English: Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
Slovenian: Beta talasemija je redka bolezen, zato je bilo zdravilo Zynteglo 24. januarja 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: In these studies, out of the 14 patients who did not completely lack beta-globin and were given Zynteglo, 11 of them had sufficiently high levels of red blood cells so that they did not need blood transfusions for at least 1 year after treatment.
Slovenian: V teh študijah je imelo izmed 14 bolnikov, ki jim ni v celoti primanjkovalo beta-globina in so prejemali zdravilo Zynteglo, 11 bolnikov dovolj visoke ravni rdečih krvnih celic, tako da vsaj eno leto po zdravljenju niso potrebovali transfuzije krvi.
English: It is given as an infusion (drip) into a vein and the dose depends on the bodyweight of the patient.
Slovenian: Daje se z infundiranjem (kapalno infuzijo) v veno, odmerek pa je odvisen od telesne mase bolnika.
English: Zynteglo must not be used in pregnant or breastfeeding women, and in patients who have previously had gene therapy treatment (medicine that delivers genes).
Slovenian: Zdravilo Zynteglo se ne sme uporabljati pri nosečnicah ali ženskah, ki dojijo, ter pri bolnikih, ki so v preteklosti že bili zdravljeni z genskim zdravljenjem (zdravilom, ki prenese gene v telo).
English: Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
Slovenian: Od transfuzije odvisna beta talasemija je huda bolezen, za katero so na voljo omejene možnosti zdravljenja.
English: What benefits of Zynteglo have been shown in studies?
Slovenian: Kakšne koristi zdravila Zynteglo so se pokazale v študijah?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynteglo have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zynteglo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Zynteglo has been given ‘conditional authorisation'.
Slovenian: Zdravilo Zynteglo je pridobilo „pogojno dovoljenje za promet“.
English: For more information about using Zynteglo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Zynteglo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The company will also provide data from a registry of patients treated with Zynteglo to study its longterm safety and effectiveness, as well as further data on the tests used in the manufacturing of the medicine to ensure its quality.
Slovenian: Hkrati bo predložilo podatke iz registra bolnikov, ki se zdravijo z zdravilom Zynteglo, s pomočjo katerih bo proučilo dolgoročno varnost in učinkovitost zdravila, ter dodatne podatke o testih, ki se uporabljajo pri proizvodnji zdravila, da se zagotovi njegova kakovost.
English: What are the risks associated with Zynteglo?
Slovenian: Kakšna tveganja so povezana z zdravilom Zynteglo?
English: When these modified cells are given back to the patient, they are transported in the bloodstream to the bone marrow where they start to make healthy red blood cells that produce beta-globin.
Slovenian: Ko se te spremenjene celice vrnejo bolniku, se prenesejo iz krvnega obtoka v krvni mozeg, kjer začnejo proizvajati zdrave rdeče krvne celice, ki tvorijo beta-globin.
English: Studies show that with a one-time treatment with Zynteglo most patients no longer need blood transfusions to increase their levels of working red blood cells.
Slovenian: Študije kažejo, da večina bolnikov z enkratnim zdravljenjem z zdravilom Zynteglo ne potrebuje več transfuzije krvi, da bi povečali svojo raven delujočih rdečih krvnih celic.
English: Zynteglo is made individually for each patient out of stem cells collected from their blood, and must only be given to the patient for whom it is made.
Slovenian: Zdravilo Zynteglo je izdelano za vsakega bolnika posebej iz matičnih celic, pridobljenih iz njihove krvi, zato se mora dajati samo tistemu bolniku, za katerega je bilo izdelano.
English: People with this genetic condition cannot make enough beta-globin, a component of haemoglobin, the protein in red blood cells that carries oxygen around the body.
Slovenian: Ljudje s to genetsko boleznijo ne morejo proizvajati dovolj beta-6globina, sestavine hemoglobina, tj. beljakovine v rdečih krvnih celicah, ki prenaša kisik po telesu.
English: The effects of Zynteglo are expected to last for the patient's lifetime.
Slovenian: Pričakovano je, da učinki zdravila Zynteglo trajajo vse bolnikovo življenje.
English: Since Zynteglo has been given conditional authorisation, the company that markets Zynteglo will provide results of ongoing studies to further assess the effectiveness and safety of the medicine.
Slovenian: Ker je zdravilo Zynteglo pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo rezultate potekajočih študij, s pomočjo katerih bo dodatno ocenilo učinkovitost in varnost zdravila.
English: Zynteglo is used in patients who do not completely lack beta-globin and who are eligible for stem cell transplantation but do not have a matching related donor.
Slovenian: Zdravilo Zynteglo se uporablja pri bolnikih, ki niso povsem brez beta globina in so primerni za presaditev matičnih celic, vendar nimajo ustreznega darovalca.
English: Zynteglo is a medicine used to treat a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions.
Slovenian: Zynteglo je zdravilo, ki se uporablja za zdravljenje krvnih motenj, znanih kot beta talasemija, pri bolnikih, starih 12 let in več, ki potrebujejo redno transfuzijo krvi.