FrancophonIA/ELRC3.0 huggingface dataset:
English: Leganto is a range of transdermal patches (patches that deliver a medicine across the skin).
Slovenian: Zdravilo Leganto je serija transdermalnih obližev (ki dovajajo zdravilo skozi kožo).
English: The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
Slovenian: Obliž se namesti na suho, čisto, zdravo kožo na trebuhu, stegnu, kolku, boku, ramenu ali nadlakti.
English: Two of these studies also compared Leganto with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Slovenian: V dveh od teh študij so zdravilo Leganto primerjali tudi z drugimi agonisti dopamina (ropinirolom v zgodnji fazi bolezni in pramipeksolom pri napredovali bolezni).
English: In moderate to severe restless legs syndrome, Leganto has been compared with placebo in two main studies involving a total of 963 patients.
Slovenian: Pri zmernem do hudem sindromu nemirnih nog so zdravilo Leganto primerjali s placebom v dveh glavnih študijah, v katerih je sodelovalo skupaj 963 bolnikov.
English: The most common side effects with Leganto in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin.
Slovenian: Najpogostejši neželeni učinki zdravila Leganto pri bolnikih s Parkinsonovo boleznijo (opaženi pri več kot 1 bolniku od 10) so zaspanost, omotica, glavobol, navzeja (slabost), bruhanje in reakcije na mestu nanosa, npr. pordelost, srbečica in vzdraženost kože.
English: In smaller studies completed later, the effectiveness of Leganto was found to be comparable with ropinirole.
Slovenian: V manjših študijah, izvedenih naknadno, je bila učinkovitost zdravila Leganto primerljiva z ropinirolom.
English: In Parkinson's disease, Leganto has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease.
Slovenian: Pri zdravljenju Parkinsonove bolezni so zdravilo Leganto primerjali s placebom (zdravilom brez zdravilne učinkovine) v štirih študijah, v katerih je sodelovalo 830 bolnikov v zgodnjem stadiju bolezni in 842 bolnikov z napredovalo boleznijo.
English: The CHMP decided that Leganto's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Leganto večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For the full list of all side effects reported with Leganto, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Leganto, glejte navodilo za uporabo.
English: Why has Leganto been approved?
Slovenian: Zakaj je bilo zdravilo Leganto odobreno?
English: The maximum dose is 8 mg/24 h for early-stage Parkinson's disease and 16 mg/24 h for advanced disease.
Slovenian: V zgodnji fazi Parkinsonove bolezni je najvišji odmerek 8 mg/24 h, pri napredovali bolezni pa 16 mg/24 h. Pri sindromu nemirnih nog znaša največji odmerek 3 mg/24 h.
English: To avoid skin burns, Leganto must be removed if the patient has to have magnetic resonance imaging (MRI) or cardioversion (a process that restores the heart's normal rhythm).
Slovenian: Če je treba pri bolniku opraviti magnetnoresonančno slikanje (MRI) ali kardioverzijo (postopek za ponovno vzpostavitev normalnega srčnega ritma), je treba obliž Leganto odstraniti, da se preprečijo opekline kože.
English: In advanced Parkinson's disease, patients using Leganto had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Leganto compared with 0.9 h with placebo).
Slovenian: Pri napredovali Parkinsonovi bolezni se je pri bolnikih, ki so uporabljali zdravilo Leganto, obdobje „izklopa“ skrajšalo bolj (zmanjšanje za 2,1 do 2,7 ure pri uporabi zdravila Leganto v primerjavi s zmanjšanjem za 0,9 ure pri uporabi placeba).
English: In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application site reactions, asthenic conditions (conditions such as tiredness, weakness and feeling unwell) and headache.
Slovenian: Pri bolnikih s sindromom nemirnih nog so najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) slabost, reakcije na mestu nanosa, astenična stanja (stanja, kot so utrujenost, šibkost in občutek nelagodja) ter glavobol.
English: The decrease seen with Leganto was similar to that seen with pramipexole (2.8 h).
Slovenian: Skrajšanje tega obdobja pri uporabi zdravila Leganto je bilo podobno kot pri uporabi pramipeksola (2,8 ure).
English: What is Leganto used for?
Slovenian: Za kaj se zdravilo Leganto uporablja?
English: In restless legs syndrome, patients using doses of Leganto between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Slovenian: Pri sindromu nemirnih nog so rezultati obeh lestvic za merjenje simptomov v obeh študijah pokazali, da je prišlo do večjega izboljšanja pri bolnikih, ki so uporabljali zdravilo Leganto v odmerku od 1 do 3 mg/24 h, kot pri tistih, ki so uporabljali placebo.
English: What is Leganto?
Slovenian: Kaj je zdravilo Leganto?
English: How has Leganto been studied?
Slovenian: Kako je bilo zdravilo Leganto raziskano?
English: How does Leganto work?
Slovenian: Kako zdravilo Leganto deluje?
English: A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson's disease.
Slovenian: Na začetku zdravljenja zgodnje faze Parkinsonove bolezni je bolnikom v pomoč poseben komplet z obliži štirih različnih jakosti.
English: Leganto delivers a constant supply of rotigotine through the skin into the bloodstream.
Slovenian: Zdravilo Leganto skozi kožo v krvni obtok dovaja stalno količino rotigotina.
English: Two smaller studies comparing Leganto with ropinirole were completed after the medicine's authorisation.
Slovenian: Po odobritvi zdravila sta bili izvedeni še dve manjši študiji, v katerih so zdravilo Leganto primerjali z ropinirolom.
English: How is Leganto used?
Slovenian: Kako se zdravilo Leganto uporablja?
English: What measures are being taken to ensure the safe and effective use of Spectrila?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Spectrila?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom multiply, and so its reduction in the blood causes the cells to die.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom razmnoževanje, zato upad njene ravni v krvi povzroči odmrtje teh celic.
English: Other information about Spectrila
Slovenian: Druge informacije o zdravilu Spectrila
English: The full EPAR and risk management plan summary for Spectrila 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) in povzetek načrta obvladovanja tveganj za zdravilo Spectrila sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available.
Slovenian: Zdravnik mora zdravilo dati v bolnišničnem okolju, kjer je na voljo oprema za oživljanje.
English: This is a summary of the European public assessment report (EPAR) for Spectrila.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Spectrila.
English: It is not intended to provide practical advice on how to use Spectrila.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient's age and body surface area.
Slovenian: Zdravilo Spectrila se daje vsake tri dni z infundiranjem (kapalno infuzijo) v veno, odmerek pa je odvisen od bolnikove starosti in telesne površine.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Spectrila večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What is Spectrila and what is it used for?
Slovenian: Kaj je zdravilo Spectrila in za kaj se uporablja?
English: A risk management plan has been developed to ensure that Spectrila is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Spectrila je bil pripravljen načrt obvladovanja tveganj.
English: What benefits of Spectrila have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Spectrila izkazalo v študijah?
English: What are the risks associated with Spectrila?
Slovenian: Kakšna tveganja so povezana z zdravilom Spectrila?
English: Why is Spectrila approved?
Slovenian: Zakaj je bilo zdravilo Spectrila odobreno?
English: The cancer cells need this amino acid to grow and
Slovenian: Rakave celice to aminokislino potrebujejo za rast in
English: Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
Slovenian: V nasprotju z njimi pa normalne celice lahko proizvajajo lasten asparagin, zato ima zdravilo nanje manjši vpliv.
English: In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.
Slovenian: V študiji s 199 otroki z ALL je bilo zdravilo Spectrila pri zmanjševanju koncentracije asparagina v krvi enako učinkovito kot drugo zdravilo z asparaginazo (obe sta se uporabljali v kombinaciji z drugimi zdravili): zaloge asparagina v krvi so se izpraznile (zmanjšale) pri 95 % bolnikov, zdravljenih z zdravilom Spectrila, in pri 94 % bolnikov, zdravljenih z drugim zdravilom, ki vsebuje asparaginazo.
English: It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment.
Slovenian: Prav tako ga ne smemo uporabljati pri bolnikih, ki so kadar koli imeli pankreatitis ali hude krvavitve ali krvne strdke po zdravljenju z asparaginazo.
English: The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests.
Slovenian: Najpogostejši neželeni učinki zdravila Spectrila (ki lahko prizadenejo več kot 1 osebo od 10) so alergijske reakcije (vključno z vročinskimi oblivi, izpuščajem, nizkim krvnim tlakom, koprivnico in težavami z dihanjem), driska, slabost, bruhanje, bolečine v trebuhu, utrujenost, otekanje (zaradi nabiranja tekočine), visoka raven sladkorja v krvi in nizka raven albumina (določene vrste beljakovine) v krvi ter druge nenormalne vrednosti krvnih preiskav.
English: For more information about treatment with Spectrila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Spectrila preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Spectrila asparaginase
Slovenian: Spectrila asparaginaza
English: As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk minimisation plan.
Slovenian: Kar se tiče tveganj, so neželeni učinki zdravila Spectrila podobni kot pri drugih zdravilih z asparaginazo in so obravnavani v načrtu za zmanjševanje tveganja za to zdravilo.
English: Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.
Slovenian: Čeprav so podatki pri odraslih omejeni, je z asparaginazo dovolj kliničnih izkušenj, zato je pričakovati, da bodo koristi zdravila Spectrila podobne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Spectrila, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Spectrila naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Spectrila is effective at reducing blood asparagine that the cancer cells need to survive.
Slovenian: Zdravilo Spectrila je učinkovito pri zmanjševanju količine asparagina v krvi, ki ga za preživetje potrebujejo rakave celice.
English: How does Spectrila work?
Slovenian: Kako zdravilo Spectrila deluje?
English: The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.
Slovenian: Najresnejši neželeni učinki zdravila Spectrila vključujejo hude alergijske reakcije, krvne strdke, pankreatitis (vnetje trebušne slinavke) in težave z jetri.
English: Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems.
Slovenian: Zdravila Spectrila ne smemo uporabljati pri bolnikih, ki so alergični na katero koli zdravilo z asparaginazo, in bolnikih s pankreatitisom (vnetjem trebušne slinavke), hudo jetrno boleznijo ali motnjami strjevanja krvi.
English: For the full list of side effects reported with Spectrila, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Spectrila, glejte navodilo za uporabo.
English: The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine.
Slovenian: Zdravilna učinkovina zdravila Spectrila, asparaginaza, je encim, ki razgrajuje aminokislino asparagin in zmanjšuje njeno koncentracijo v krvi.
English: How is Spectrila used?
Slovenian: Kako se zdravilo Spectrila uporablja?
English: Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines.
Slovenian: Spectrila je zdravilo za zdravljenje akutne limfoblastne levkemije (ALL), vrste raka belih krvnih celic, imenovanih limfoblasti.
English: Only healthcare professionals experienced in cancer treatments should prescribe and give Spectrila.
Slovenian: Zdravilo Spectrila lahko predpisujejo in dajejo samo zdravniki, ki imajo izkušnje z zdravljenjem raka.
English: Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.
Slovenian: Na voljo je v viali kot prašek za pripravo raztopine za infundiranje.
English: Strength Pharmaceutical Form Route of administration Packaging
Slovenian: Številka EU Izmišljeno ime Jakost Farmacevtska oblika
English: EU Numbers
Slovenian: Ovojnina
English: Invented name
Slovenian: Pot uporabe
English: • Clear information about their difference in concentration.
Slovenian: • Jasne informacije o razliki v koncentraciji.
English: • Encouragement to report medications errors and their causes and consequences.
Slovenian: • Spodbudo za prijavljanje napak pri zdravljenju, njihovih vzrokih in posledicah.
English: • Information about the potential safety risks of errors in dosing calculation resulting from the confusion between the two formulations and its possible clinical consequences (e.g. potential for thrombotic risk if overdose).
Slovenian: • Informacije o možnih varnostnih tveganjih zaradi napak v odmerjanju, ki bi se pojavile zaradi nerazlikovanja med obema formulacijama, in o možnih kliničnih posledicah (npr. o možnem tveganju za trombozo v primeru prevelikega odmerjanja).
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States.
Slovenian: Imetnik dovoljenja za promet mora ta načrt izobraževanja izvesti na državni ravni, pred prihodom nove formulacije na trg in v soglasju s pristojnimi organi Držav članic.
English: The patient information pack to be used by healthcare professionals in the education of the patients should contain the same above described key elements.
Slovenian: ¸Komplet informacij za bolnike, ki ga bodo zdravstveni delavci uporabili za izobraževanje bolnikov, mora prav tako vključevati vse zgoraj opisane ključne elemente.
English: • Clear demarcation of the new formulation of NovoSeven from original NovoSeven, with clear descriptions of any differences in the vial sizes, colour codes and dosing and reconstitution instructions
Slovenian: • Jasno razmejitev med novo formulacijo NovoSeven in prvotnim NovoSeven z jasnim opisom vseh razlik v velikosti vial, barvnem kodiranju ter navodilih za odmerjanje in rekonstitucijo.
English: Both information packs are to be used as part of an educational plan provided to minimise risk of medication errors that may be associated with the change in concentration of the new Novoseven formulation.
Slovenian: Oba izobraževalna kompleta je treba uporabiti v okviru načrta izobraževanja, namenjenega zmanjšanju tveganja za napake pri uporabi zdravila, ki bi se lahko pojavile zaradi spremenjene koncentracije nove formulacije NovoSeven.
English: The physician information should contain the following key elements:
Slovenian: Informacije za zdravnike morajo vključevati naslednje ključne elemente:
English: • Dosing reference card
Slovenian: • Referenčno kartico za odmerjanje
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all physicians who are expected to prescribe/use NovoSeven are provided with an Educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet zagotavlja, da bodo ob prihodu zdravila na trg vsi zdravniki, ki bodo predvidoma predpisovali oz. uporabljali NovoSeven, dobili izobraževalno gradivo.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO VPELJATI DRŽAVE ČLANICE
English: • Letter to healthcare professionals
Slovenian: • Pismo zdravnikom
English: • Summary leaflet of the product features and reconstitution guide, including highlighted changes that have been made for the new formulation of NovoSeven.
Slovenian: • Povzetek lastnosti zdravila in navodilo za rekonstitucijo s poudarjenimi spremembami,
English: The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da bodo vpeljeni vsi spodaj opisani pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila,
English: The physician information pack should contain the following:
Slovenian: Komplet informacij za zdravnike mora vsebovati:
English: • Educational slide kit
Slovenian: • Izobraževalni komplet prosojnic
English: • Question & Answer booklet
Slovenian: • Knjižico z vprašanji in odgovori
English: • Physician information pack
Slovenian: • komplet informacij za zdravnike
English: It may harm them,
Slovenian: ki ga še prenašajo:
English: Date of first authorisation: 01 December 2008 Date of latest renewal: 31 July 2013
Slovenian: Datum prve odobritve: 01. december 2008 Datum zadnjega podaljšanja: 31 julij 2013
English: However, this has not been established in the target population.
Slovenian: Vendar pa le-teh niso ugotavljali pri ciljni populaciji.
English: These changes are not considered to be clinically relevant, however.
Slovenian: Vendar te spremembe ne veljajo za klinično pomembne.
English: The absolute bioavailability is 85%.
Slovenian: Absolutna biološka uporabnost je 85 %.
English: Medical attention may be necessary.
Slovenian: Morda bo potrebna zdravniška pomoč.
English: The mean volume of distribution (Vd) ranged between 63-276 litres.
Slovenian: Povprečni volumen porazdelitve (Vd) je bil v okviru 63-276 litrov.
English: PA/Alu/PVC/Alu 2 years PCTFE/PVC/Alu 18 months
Slovenian: PA/Alu/PVC/Alu 2 leti PCTFE/PVC/Alu 18 mesecev
English: The amount of Zomarist that people have to take varies depending on their condition.
Slovenian: Koliko zdravila Zomarist morajo ljudje jemati, je odvisno od njihovega stanja.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah,objavljenih na evropskem spletnem portalu o zdravilih.
English: Supportive management is recommended.
Slovenian: Priporočeno je podporno zdravljenje.
English: However, the magnitude of change is not clinically significant, so that vildagliptin can be given with or without food.
Slovenian: Vendar pa velikost te spremembe ni klinično pomembna, zato se lahko vildagliptin uživa s hrano ali brez nje.
English: What Zomarist is and what it is used for
Slovenian: Kaj je zdravilo Zomarist in za kaj ga uporabljamo
English: Cardiovascular risk
Slovenian: Kardiovaskularno tveganje
English: Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Nosečnost in dojenje - Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Type 2 diabetes develops if the body does not make enough insulin or if the insulin that the body makes does not work as well as it should.
Slovenian: Diabetes tipa 2 se razvije v primeru, ko organizem ne tvori dovolj insulina, ali pa če insulin, ki ga organizem tvori, ne deluje tako, kot bi moral.
English: If you have any questions about how long to take this medicine, talk to your doctor.
Slovenian: Če vas zanima, kako dolgo morate jemati to zdravilo, se pogovorite s svojim zdravnikom.
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so definirane kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Slovenian: Pri bolnikih s povečanim tveganjem dodatnega napredovanja okvare ledvic in pri starejših je treba delovanje ledvic oceniti pogosteje, na primer vsake 3 do 6 mesecev.