FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Slovenian: Cepivo zmanjšuje znake influence in izločanje virusa po okužbi.
English: Equilis Prequenza contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Slovenian: Zdravilo Equilis Prequenza vsebuje inaktivirane cele viruse sevov influence, za katere je cepivo indicirano.
English: The initial studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age.
Slovenian: Študije so pokazale, da je zdravilo Equilis Prequenza učinkovito cepivo proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi pri konjih, starejših od šest mesecev.
English: The viruses included in the current formulation of Equilis Prequenza are grown in mammalian cells, unlike those in the initial formulation, which were grown in hens' eggs.
Slovenian: Viruse, ki so vključeni v trenutno formulacijo cepiva Equilis Prequenza, gojijo v celicah sesalcev, virusi v prvotni formulaciji cepiva pa so bili gojeni v kokošjih jajcih.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Slovenian: Ko bo imunski sistem naslednjič izpostavljen kateremu od teh virusnih sevov, bo lahko hitreje tvoril protitelesa.
English: The withdrawal period for Equilis Prequenza for meat and milk is zero days.
Slovenian: Karenca za cepivo Equilis Prequenza za meso in mleko je nič dni.
English: What benefit has Equilis Prequenza shown during the studies?
Slovenian: Kakšne koristi je zdravilo Equilis Prequenza izkazalo med študijami?
English: Most of the studies used Equilis Prequenza Te, a vaccine which protects against tetanus as well as the strains of equine influenza included in Equilis Prequenza.
Slovenian: V večini študij je bilo uporabljeno cepivo Equilis Prequenza Te, ki ščiti tako pred tetanusom in pred sevi virusov influence konj, ki so vključeni v cepivo Equilis Prequenza.
English: The antibodies will then help to protect against the disease caused by these strains of the equine influenza virus.
Slovenian: Ta mu bodo pomagala pri obrambi pred boleznijo, ki jo ti sevi virusa influence konj povzročajo.
English: Why has Equilis Prequenza been approved?
Slovenian: Zakaj je bilo zdravilo Equilis Prequenza odobreno?
English: Equilis Prequenza is used to vaccinate horses from six months of age against equine influenza.
Slovenian: Cepivo Equilis Prequenza se uporablja za cepljenje konj, ki so starejši od šestih mesecev, proti influenci konj.
English: What is the risk associated with Equilis Prequenza?
Slovenian: Kakšna tveganja so povezana s cepivom Equilis Prequenza?
English: How has Equilis Prequenza been studied?
Slovenian: Kako je bilo zdravilo Equilis Prequenza raziskano?
English: How does Equilis Prequenza work?
Slovenian: Kako zdravilo Equilis Prequenza deluje?
English: What is Equilis Prequenza?
Slovenian: Kaj je zdravilo Equilis Prequenza?
English: What is Equilis Prequenza used for?
Slovenian: Za kaj se zdravilo Equilis Prequenza uporablja?
English: Equine influenza vaccine
Slovenian: Equilis Prequenza cepivo proti influenci konj
English: Although a possible effect in these conditions was observed, several shortcomings were identified.
Slovenian: Čeprav je bil zaznan možen učinek pri teh stanjih, je bilo ugotovljenih več pomanjkljivosti.
English: 1 Dry extract (DER 3-7.4:1), extraction solvent: ethanol 40-70% (V/V).
Slovenian: 1 Suhi ekstrakt (DER 3-7,4:1), ekstrakcijsko topilo: etanol 40-70 % (v/v).
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Slovenian: To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njegovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
English: This means that, although there is insufficient evidence from clinical studies, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Slovenian: To pomeni, da je kljub pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedeni način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
English: Results showed improvements in the time it takes to fall asleep and sleep quality.
Slovenian: Rezultati so pokazali izboljšanje v smislu časa, potrebnega za uspavanje, in kakovosti spanja.
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian root medicines.
Slovenian: Bolniki z odprtimi ranami, težavami s kožo, zelo povišano telesno temperaturo, hudimi okužbami ter resnimi težavami s srcem in prekrvavitvijo se ne smejo kopati v kopelih z zdravili, ki vsebujejo korenino zdravilne špajke.
English: DER or drug extract ratio is the ratio between the amount of herbal substance used and the quantity of extract obtained.
Slovenian: DER ali razmerje med rastlinsko drogo in ekstraktom je razmerje med uporabljeno količino rastlinske snovi in količino pridobljenega ekstrakta.
English: Valerian root medicines should be used only in adults and adolescents over the age 12 years.
Slovenian: Zdravila, ki vsebujejo korenino zdravilne špajke, se smejo uporabljati samo pri odraslih in mladostnikih, starejših od 12 let.
English: Valerian root is the common name for the underground parts of the plant Valeriana officinalis L.
Slovenian: Korenina zdravilne špajke je splošno ime za podzemne dele rastline Valeriana officinalis L.
English: This summary is not intended to provide practical advice on how to use medicines containing valerian root.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo korenino zdravilne špajke.
English: When used for the relief of mild nervous tension and sleep disorders, if symptoms persist or worsen after 2 weeks of continued use with the medicine, a doctor should be consulted.
Slovenian: Kadar se zdravilo uporablja za lajšanje blage živčne napetosti in motenj spanja in simptomi po dveh tednih neprekinjene uporabe zdravila ne izginejo ali se poslabšajo, se je treba posvetovati z zdravnikom.
English: These include nausea and abdominal cramps.
Slovenian: Ti vključujejo slabost in trebušne krče.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian root.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo korenine zdravilne špajke.
English: The other herbal preparations of valerian root are available in solid or liquid form to be taken by mouth.
Slovenian: Drugi pripravki rastlinskega izvora s korenino zdravilne špajke so na voljo v trdni ali tekoči obliki za jemanje skozi usta.
English: The way valerian root medicines work is not fully known, but from some experiments it is thought that effects on the brain leading to relaxation and sleepiness might play a role.
Slovenian: Način delovanja zdravil s korenino zdravilne špajke ni v celoti znan, vendar nekateri poskusi kažejo, da morda vplivajo na možgane ter povzročajo sprostitev in zaspanost.
English: How does valerian root work as a medicine?
Slovenian: Kako korenina zdravilne špajke deluje kot zdravilo?
English: Further information on the risks associated with valerian root 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 korenino 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 conclusions only cover valerian root preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the underground parts of the plant, by expressing the juice of the fresh root, and as dry or liquid extracts.
Slovenian: Zaključki odbora HMPC zajemajo samo pripravke s korenino zdravilne špajke, ki se pridobivajo s sušenjem in drobljenjem (zmanjševanjem na majhne delce) ali z drobljenjem podzemnih delov rastline v prah, z iztiskanjem soka iz sveže korenine in kot suhi ali tekoči ekstrakti.
English: In its assessment, the HMPC also considered clinical studies involving patients with mild symptoms of mental stress and insomnia (difficulty sleeping).
Slovenian: V svoji oceni je odbor HMPC prav tako upošteval klinične študije, ki so vključevale bolnike z blagimi simptomi stresa in nespečnosti (težav s spanjem).
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian root.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo korenino zdravilne špajke.
English: Any applications for the licensing of medicines containing valerian root 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 korenino 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 root 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 korenino 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: Herbal medicines containing comminuted valerian root are usually available as herbal tea to be drunk or as bath additives.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo zdrobljeno korenino zdravilne špajke, so navadno na voljo kot zdravilni čaj, ki se popije, ali kot dodatek kopeli.
English: Information on the use and licensing of valerian root medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo korenino zdravilne špajke, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Extracts are prepared using a technique to extract compounds by putting the plant material in a solvent (such as ethanol, methanol or water) to dissolve compounds and form a liquid extract.
Slovenian: Ekstrakti se pripravljajo z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol, metanol ali vodo), v katerem se raztopijo spojine in se pridobi tekoči ekstrakt.
English: How are valerian root medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo korenino zdravilne špajke, odobrena v EU?
English: Valerian root preparations may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki s korenino zdravilne špajke so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Detailed instructions on how to take valerian root 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 korenino zdravilne špajke, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: What evidence supports the use of valerian root medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo korenino zdravilne špajke?
English: The HMPC conclusions on the use of other valerian medicines for relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi drugih zdravil, ki vsebujejo zdravilno špajko, za lajšanje blagih simptomov stresa in kot pomoč pri spanju temeljijo na njihovi „tradicionalni uporabi“.
English: For more information about treatment with valerian root 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 korenino zdravilne špajke, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about valerian root medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo korenino zdravilne špajke
English: The HMPC also concluded that, on the basis of its long-standing use, the other valerian root preparations described above can be used for relief of mild symptoms of mental stress and to aid sleep.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe prav tako zaključil, da se lahko drugi zgoraj opisani pripravki s korenino zdravilne špajke uporabljajo za lajšanje blagih simptomov stresa in kot pomoč pri spanju.
English: Therefore, the HMPC conclusions on these uses of valerian root medicines are based on their long-standing use.
Slovenian: Zaključki odbora HMPC v zvezi s tovrstno uporabo zdravil, ki vsebujejo korenino zdravilne špajke, zato temeljijo na njihovi dolgotrajni uporabi.
English: What are the risks associated with valerian root medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo korenino zdravilne špajke?
English: The HMPC considered that clinical studies with dry ethanol extracts support its use for relief of mild nervous tension and in sleep disorders.
Slovenian: Odbor HMPC je presodil, da klinične študije s suhimi etanolnimi ekstrakti podpirajo njegovo uporabo za lajšanje blage živčne napetosti in motenj spanja.
English: For practical information about using valerian root 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: The HMPC concluded that a specific valerian root preparation obtained as dry ethanol extract1 can be used for the relief of mild nervous tension and sleep disorders.
Slovenian: Odbor HMPC je zaključil, da se lahko poseben pripravek s korenino zdravilne špajke, pridobljen kot suhi etanolni ekstrakt1, uporablja za lajšanje blage živčne napetosti in motenj spanja.
English: The HMPC conclusions on the use of a specific valerian root preparation obtained as dry ethanol extract for the relief of mild nervous tension and sleep disorders are based on their ‘well-established use'.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo posebnega pripravka s korenino zdravilne špajke, pridobljenega kot suhi etanolni ekstrakt, za lajšanje blage živčne napetosti in motenj spanja temeljijo na njegovi „dobro uveljavljeni medicinski uporabi“.
English: What is valerian root?
Slovenian: Kaj je korenina zdravilne špajke?
English: For dry extracts, the solvent is then evaporated off.
Slovenian: Topilo se nato odpari, s čimer se pridobi suhi ekstrakt.
English: A doctor or healthcare practitioner should be consulted if symptoms persist during treatment for mental stress and to aid sleep.
Slovenian: Če simptomi med lajšanjem stresa in kot pomoč pri spanju ne izginejo, se je treba posvetovati z zdravnikom ali zdravstvenim delavcem.
English: Side effects have been reported with valerian root.
Slovenian: Pri uporabi korenine zdravilne špajke so poročali o neželenih učinkih.
English: 1 MU: Million Units
Slovenian: *ME: Milijonov Enot
English: EU - Number
Slovenian: EU številka
English: Pharmaceutical
Slovenian: Farmacevtska oblika
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dynastat on 22 March 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dynastat, veljavno po vsej Evropski uniji, odobrila dne 22. marca 2002.
English: • a history of serious allergic reactions to medicines, especially skin reactions;
Slovenian: • anamnezo hudih alergijskih reakcij na zdravila, še zlasti kožnih reakcij;
English: It was generally more effective than placebo and as effective as other painkillers.
Slovenian: Na splošno je bilo učinkovitejše od placeba in enako učinkovito kot druga zdravila proti bolečinam.
English: This means that it is converted to valdecoxib in the body.
Slovenian: To pomeni, da se v telesu pretvori v valdekoksib.
English: Other information about Dynastat:
Slovenian: Druge informacije o zdravilu Dynastat:
English: Dynastat parecoxib
Slovenian: Dynastat parekoksib
English: This document is a summary of the European public assessment report (EPAR) for Dynastat.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dynastat.
English: The main measures of effectiveness were changes in pain scores as rated by the patients.
Slovenian: Glavno merilo učinkovitosti so bile spremembe rezultatov v zvezi z bolečino, kot so jo ocenili bolniki.
English: Dynastat must not be used in patients with:
Slovenian: Zdravila Dynastat ne smejo uporabljati bolniki z:
English: What benefit has Dynastat shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dynastat izkazalo med študijami?
English: The CHMP decided that Dynastat's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Dynastat večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Dynastat can be given at the same time as opioid painkillers (medicines that are related to morphine).
Slovenian: Zdravilo Dynastat se lahko daje sočasno z opioidnimi protibolečinskimi zdravili (zdravili, ki so povezana z morfinom).
English: It must not be used after coronary bypass surgery.
Slovenian: Ne sme se uporabljati po obvodni operaciji koronarnih arterij.
English: Dynastat must not be given to women during the last three months of pregnancy or to breast-feeding women.
Slovenian: Zdravilo Dynastat se ne sme dajati nosečnicam v zadnjem trimesečju ali doječim materam.
English: • allergic-type reactions such as bronchospasm (excessive and prolonged contraction of the airway muscles), cold-like symptoms, polyps in the nose, swelling of the face or hives after taking aspirin or NSAIDs, including other COX-2 inhibitors;
Slovenian: • alergijskimi reakcijami, kot so bronhospazem (prekomerno in dlje časa trajajoče skrčenje mišic v dihalnih poteh), prehladu podobni simptomi, polipi v nosu, otekanje obraza ali izpuščaji po zaužitju aspirina ali nesteroidnih protivnetnih zdravil, vključno z drugimi zaviralci COX-2;
English: What is the risk associated with Dynastat?
Slovenian: Kakšna tveganja so povezana z zdravilom Dynastat?
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 Dynastat.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dynastat, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It is available as a powder to be made up into a solution for injection, in vials containing 20 or 40 mg of parecoxib, with or without a solvent.
Slovenian: Na voljo v obliki praška za pripravo raztopine za injiciranje v vialah, ki vsebujejo 20 ali 40 mg parekoksiba, z vehiklom ali brez njega.
English: The most common side effect with Dynastat (seen in more than 1 patient in 10) is nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinek zdravila Dynastat (opažen pri 1 bolniku od 10) je navzeja (slabost).
English: Dynastat must not be used in people who are hypersensitive (allergic) to parecoxib or any of the other ingredients.
Slovenian: Zdravila Dynastat ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) parekoksib ali katerokoli drugo sestavino zdravila.
English: In patients with severe kidney problems or who are likely to develop fluid retention, treatment should start with the lowest dose and the patient's kidneys should be monitored closely.
Slovenian: Pri bolnikih s hudo okvaro ledvic ali tistih, nagnjenih k zastajanju tekočine, je treba zdravljenje začeti z najnižjim odmerkom, pri čemer je treba skrbno spremljati delovanje bolnikovih ledvic.
English: Dynastat is used in adults for the short-term treatment of pain after an operation.
Slovenian: Zdravilo Dynastat se uporablja pri odraslih za kratkotrajno zdravljenje bolečin po operaciji.
English: Valdecoxib is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oxygenase-2 (COX-2) inhibitors'.
Slovenian: Valdekoksib je nesteroidno protivnetno zdravilo (NSAID), ki spada v skupino zdravil, imenovanih zaviralci ciklooksigenaze-2 (COX-2).
English: Dynastat has been studied in 2,582 adults who had undergone a variety of surgical procedures including dental, orthopaedic (bone), gynaecological or coronary (heart) bypass surgery.
Slovenian: Zdravilo Dynastat so proučevali pri 2 582 odraslih bolnikih, ki so prestali različne kirurške posege, vključno z zobozdravstvenimi, ortopedskimi (kostnimi), ginekološkimi posegi ali obvodno operacijo koronarnih (srčnih) arterij.
English: Dynastat was also shown to reduce the need for morphine, but this reduction did not seem to be accompanied with a reduction in the side effects associated with morphine.
Slovenian: Za zdravilo Dynastat so dokazali tudi, da zmanjša potrebo po morfinu, vendar pa slednje ni zagotovilo zmanjšanja neželenih učinkov, ki so povezani z morfinom.
English: By reducing the production of prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.
Slovenian: Zdravilo Dynastat z zmanjšanjem nastajanja prostaglandinov pomaga ublažiti simptome vnetja, vključno z bolečino.
English: Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ketorolac, morphine, valdecoxib, ibuprofen and tramadol.
Slovenian: Zdravilo Dynastat so primerjali s placebom (zdravilom brez zdravilne učinkovine) in tudi z drugimi zdravili proti bolečinam, kot so ketorolak, morfin, valdekoksib, ibuprofen in tramadol.
English: As with other medicines in the same group as Dynastat, the risk of heart and blood vessel problems may increase with higher doses and longer durations of Dynastat treatment.
Slovenian: Kot pri drugih zdravilih iz skupine, v katero spada zdravilo Dynastat, se lahko z višjimi odmerki in daljšim trajanjem zdravljenja z zdravilom Dynastat poveča tveganje za težave s srcem in ožiljem.
English: The shortest duration possible and the lowest effective dose of Dynastat should be used.
Slovenian: Zdravilo Dynastat je treba uporabljati čim krajše možno obdobje in v najnižjem še učinkovitem odmerku.
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Slovenian: Z zaviranjem encima COX-2 povzroči zmanjšanje nastajanja prostaglandinov, snovi, ki sodelujejo pri vnetnem procesu.