FrancophonIA/ELRC3.0 huggingface dataset:
English: La Selva, 135 17170 Amer SPAIN
Slovenian: 17170 Amer SPAIN
English: Thiomersal: ………………..0.05 mg Whitish emulsion.
Slovenian: Tiomersal: ………………0,05 mg
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 ….
Slovenian: Virus hemoragične bolezni kuncev tipa 2(RHDV2),
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Slovenian: Virus hemoragične bolezni kuncev tipa 2 (RHDV2), sev V-1037, inaktiviran ≥70% cELISA40 ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
English: Inactivated RHDV2, strain V-1037: ……… ≥70% cELISA40*
Slovenian: RHDV2, sev V-1037, inaktiviran: ≥70% cELISA40 ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
English: HIPRA DEUTSCHLAND GmbH Tel: (+49) 211 698236 - 0
Slovenian: Tel: (+49) 211 698236 - 0
English: HIPRA BENELUX NV Tel: (+32) 9 324 21 58
Slovenian: Tel: (+32) 9 324 21 58
English: To be supplied only on veterinary prescription.
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian essential oil medicines.
Slovenian: Bolniki z odprtimi ranami, težavami s kožo, močno povišano telesno temperaturo, hudimi okužbami ter resnimi težavami s srcem in prekrvavitvijo se ne smejo kopati v kopelih z zdravili, ki vsebujejo eterično olje zdravilne špajke.
English: Valerian essential oil medicines should be used only in adults and adolescents over the age of 12 years.
Slovenian: Zdravila, ki vsebujejo eterično olje zdravilne špajke, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
English: Valerian essential oil is the common name for the essential oil extracted from the underground parts of the plant Valeriana officinalis L.
Slovenian: Eterično olje zdravilne špajke je splošno ime za eterično olje, ekstrahirano iz podzemnih delov rastline Valeriana officinalis L.
English: If symptoms continue during the use of the medicine, a doctor or a healthcare practitioner should be consulted.
Slovenian: Če simptomi med uporabo zdravila ne popustijo, se je treba posvetovati z zdravnikom ali zdravstvenim delavcem.
English: This summary is not intended to provide practical advice on how to use medicines containing valerian essential oil.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo eterično olje zdravilne špajke.
English: Further information on the risks associated with these valerian essential oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo eterično olje zdravilne špajke, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC noted the lack of clinical studies with valerian essential oil medicines, but took into account the well documented use of this herbal medicine.
Slovenian: Odbor HMPC je ugotovil pomanjkanje kliničnih študij z zdravili, ki vsebujejo eterično olje zdravilne špajke, vendar je upošteval dobro dokumentirano uporabo tega zdravila rastlinskega izvora.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian essential oil.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo eteričnega olja zdravilne špajke.
English: The HMPC conclusions on the use of these valerian essential oil medicines for the relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo eterično olje zdravilne špajke, za lajšanje blagih simptomov stresa in kot pomoč pri spanju temeljijo na njihovi „tradicionalni uporabi“.
English: The HMPC concluded that, on the basis of its long-standing use, valerian essential oil can be used for relief of mild symptoms of mental stress and to aid sleep.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko eterično olje zdravilne špajke uporablja za lajšanje blagih simptomov stresa in kot pomoč pri spanju.
English: Herbal medicines containing valerian essential oil are usually available in liquid forms to be taken by mouth or used as bath additives.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo eterično olje zdravilne špajke, so navadno na voljo v tekoči obliki za jemanje skozi usta ali kot dodatek kopeli.
English: Any applications for the licensing of medicines containing valerian essential oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo eterično olje zdravilne špajke, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Further information on the HMPC assessment of valerian essential oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo eterično olje zdravilne špajke, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian essential oil.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo eterično olje zdravilne špajke.
English: Valerian essential oil EMA/154066/2016
Slovenian: EMA/154066/2016
English: Information on the use and licensing of valerian essential oil medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo eterično olje zdravilne špajke, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Valerian essential oil is obtained by directing steam through the underground parts of the plant.
Slovenian: Eterično olje zdravilne špajke se pridobiva z uvajanjem pare skozi podzemne dele rastline.
English: Valerian essential oil may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Eterično olje zdravilne špajke je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Detailed instructions on how to take valerian essential oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo eterično olje zdravilne špajke, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: For more information about treatment with valerian essential oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo eterično olje zdravilne špajke, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: What evidence supports the use of valerian essential oil medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo eterično olje zdravilne
English: Other information about valerian essential oil medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo eterično olje zdravilne špajke
English: What is valerian essential oil?
Slovenian: Kaj je eterično olje zdravilne špajke?
English: What are the risks associated with valerian essential oil medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo eterično olje zdravilne
English: For practical information about using valerian essential oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: How are valerian essential oil medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo eterično olje zdravilne špajke, odobrena v
English: Side effects have been reported with valerian essential oil medicines.
Slovenian: Pri uporabi zdravil, ki vsebujejo eterično olje zdravilne špajke, so poročali o neželenih učinkih.
English: United Kingdom Medimpex UK LTD 127 Shirland road,
Slovenian: Združeno kraljestvo Medimpex UK LTD 127 Shirland road,
English: Annex I List of medicinal products and presentations
Slovenian: Priloga I Seznam poimenovanj, farmacevtskih oblik, jakosti, poti uporabe, imetnikov dovoljenj za promet v državah članicah
English: The main measure of effectiveness was overall survival (how long the patients lived).
Slovenian: Glavno merilo učinkovitosti je bil celokupni čas preživetja (kako dolgo so bolniki živeli).
English: Onivyde (irinotecan)
Slovenian: Onivyde (irinotekan)
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu311933.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu311933.
English: What measures are being taken to ensure the safe and effective use of Onivyde?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Onivyde?
English: In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer.
Slovenian: V Evropi je irinotekan že več let odobren za zdravljenje kolorektalnega raka.
English: Metastatic means that the cancer has spread to other parts of the body.
Slovenian: „Metastatski“ pomeni, da se je rak razširil na druge dele telesa.
English: Onivyde received a marketing authorisation valid throughout the EU on 14 October 2016.
Slovenian: Za zdravilo Onivyde je bilo 14. oktobra 2016 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
English: The European Medicines Agency decided that Onivyde's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Onivyde večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: As for all medicines, data on the use of Onivyde are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Onivyde stalno spremljajo.
English: Further information on Onivyde can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Onivyde.
Slovenian: Nadaljnje informacije o zdravilu Onivyde so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Onivyde.
English: The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby decreasing the rate at which irinotecan is removed from the body and allowing it to act for longer.
Slovenian: Pričakovano je, da se liposomi nakopičijo v tumorju in sčasoma počasi sproščajo zdravilo, s čimer zmanjšajo hitrost, s katero se irinotekan odstrani iz telesa, in omogočajo, da deluje dlje.
English: Other information about Onivyde
Slovenian: Druge informacije o zdravilu Onivyde
English: The recommended dose is 70 mg per square metre of body surface given every 2 weeks together with 5-fluorouracil and leucovorin.
Slovenian: Priporočeni odmerek je 70 mg na kvadratni meter telesne površine, ki se daje vsaka dva tedna skupaj s 5-fluorouracilom in levkovorinom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onivyde have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Onivyde upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Why is Onivyde authorised in the EU?
Slovenian: Zakaj je zdravilo Onivyde odobreno v EU?
English: An overview of Onivyde and why it is authorised in the EU
Slovenian: Pregled zdravila Onivyde in zakaj je odobreno v EU
English: Side effects reported with Onivyde are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Onivyde, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What is Onivyde and what is it used for?
Slovenian: Kaj je zdravilo Onivyde in za kaj se uporablja?
English: Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women.
Slovenian: Zdravilo Onivyde se ne sme dajati bolnikom, ki so imeli v preteklosti hudo preobčutljivostno (alergijsko) reakcijo na irinotekan, in ženskam, ki dojijo.
English: For more information about using Onivyde, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Onivyde glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects.
Slovenian: Zdravnik lahko prilagodi odmerek pri bolnikih, pri katerih se razvijejo hudi neželeni učinki, in tistih z določenimi genetskimi značilnostmi, ki povečajo tveganje za pojav neželenih učinkov.
English: What are the risks associated with Onivyde?
Slovenian: Kakšna tveganja so povezana z zdravilom Onivyde?
English: Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa lahko predpiše in daje le zdravnik z izkušnjami pri uporabi zdravil za zdravljenje raka.
English: It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells.
Slovenian: Ta zavira encim, imenovan topoizomeraza I, ki sodeluje pri podvajanju celične DNK, ki je potrebna za nastanek novih celic.
English: What benefits of Onivyde have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Onivyde izkazalo v študijah?
English: The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.
Slovenian: Študija je pokazala, da se je z dodajanjem zdravila Onivyde k režimu 5-fluorouracila in levkovorina podaljšalo življenje bolnikov: bolniki, ki so skupaj jemali tri zdravila, so živeli 6,1 meseca v primerjavi s 4,2 meseca pri bolnikih, ki so jemali 5-fluorouracil in levkovorin, in 4,9 meseca pri bolnikih, ki so jemali samo zdravilo Onivyde.
English: Pancreatic cancer is rare, and Onivyde was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
Slovenian: Rak trebušne slinavke je redka bolezen, zato je bilo zdravilo Onivyde 9. decembra 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination.
Slovenian: Bolniki so prejemali zdravilo Onivyde ali 5-fluorouracil in levkovorin ali vsa tri zdravila skupaj.
English: In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes'.
Slovenian: V zdravilu Onivyde je irinotekan vključen v drobne maščobne delce, imenovane liposomi.
English: The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth) and fever.
Slovenian: Najpogostejši neželeni učinki zdravila Onivyde (ki se lahko pojavijo pri več kot 1 bolniku od 5) so driska, navzeja (slabost), bruhanje, izguba teka, nevtropenija (nizke vrednosti nevtrofilcev, tj. vrste belih krvnih celic), utrujenost, oslabelost, anemija (nizka raven rdečih krvnih celic), stomatitis (vnetje ustne sluznice) in povišana telesna temperatura.
English: Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine.
Slovenian: Zdravilo Onivyde so proučevali v eni glavni študiji s 417 bolniki z metastatskim adenokarcinomom trebušne slinavke, pri katerih se je rak poslabšal kljub zdravljenju z gemcitabinom, zdravilom proti raku.
English: The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets).
Slovenian: Najpogostejši resni neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 50) so driska, navzeja in bruhanje, nevtropenija in povišana telesna temperatura, okužbe krvi ali pljuč (sepsa, pljučnica), šok, dehidracija, ledvična odpoved in trombocitopenija (nizka raven trombocitov).
English: Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.
Slovenian: Zdravilo Onivyde se uporablja skupaj s 5-fluorouracilom in levkovorinom (dvema drugima zdraviloma za zdravljenje raka) pri odraslih, pri katerih se je rak poslabšal kljub zdravljenju z gemcitabinom, tj. zdravilom za zdravljenje raka.
English: Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas.
Slovenian: Onivyde je zdravilo proti raku, ki se uporablja za zdravljenje oblike raka na trebušni slinavki, ki se imenuje metastatski adenokarcinom trebušne slinavke.
English: Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Onivyde je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Slovenian: Učinkovina v zdravilu Onivyde, irinotekan, je zdravilo za zdravljenje raka, ki spada v skupino zaviralcev topoizomeraze.
English: How is Onivyde used?
Slovenian: Kako se zdravilo Onivyde uporablja?
English: How does Onivyde work?
Slovenian: Kako zdravilo Onivyde deluje?
English: For the full list of side effects of Onivyde, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Onivyde, glejte navodilo za uporabo.
English: The Agency considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.
Slovenian: Ocenila je, da je bilo podaljšanje preživetja, ki je bilo opaženo, ko se je zdravilo Onivyde uporabljalo skupaj s 5-fluorouracilom in levkovorinom, pomembno pri predhodno zdravljenih bolnikih z metastatskim adenokarcinomom trebušne slinavke, za katere so na voljo omejene možnosti zdravljenja.
English: The full EPAR for Imatinib Accord 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 Imatinib Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alfa (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Slovenian: Uporablja se tudi pri odraslih in otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi);
English: This is a summary of the European public assessment report (EPAR) for Imatinib Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imatinib Accord.
English: Imatinib Accord is available as tablets (100 and 400 mg).
Slovenian: Na voljo je v obliki tablet (100 mg in 400 mg).
English: What measures are being taken to ensure the safe and effective use of Imatinib Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Accord?
English: Because Imatinib Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Imatinib Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Accord on 1 July 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Imatinib Accord, veljavno po vsej Evropski uniji, izdala 1. julija 2013.
English: As for every medicine, the company provided studies on the quality of Imatinib Accord.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Imatinib Accord.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Accord have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Imatinib Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Slovenian: Odmerek je odvisen od zdravljene bolezni, starosti bolnika in njegovega bolezenskega stanja ter odziva na zdravljenje, vendar ne sme presegati 800 mg na dan. Za več informacij glejte navodilo za uporabo.
English: These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Slovenian: Ti encimi so v nekaterih receptorjih na površini rakavih celic, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.