natgillin/translations-raw huggingface dataset:
Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Zdravilo Instanyl se uporablja pri bolnikih, ki že jemljejo opioide (zdravila iz skupine protibolečinskih zdravil, kamor spadata morfin in fentanil) za obvladovanje dolgotrajne bolečine pri raku.
How is Instanyl used?
Kako se zdravilo Instanyl uporablja?
Instanyl must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression (inhibition of breathing) or who have severe obstructive lung conditions (diseases that severely impede breathing).
Zdravila Instanyl ne smejo uporabljati bolniki, ki še ne jemljejo opioidov za uravnavanje bolečine, in bolniki, ki imajo resno depresijo dihanja (oteženo dihanje) ali obolenje s hudo obstrukcijo pljuč (bolezen, pri kateri je dihanje močno ovirano).
The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain relief.
Največji odmerek je bil 200 mikrogramov, ki so ga bolniki jemali kot en vpih v eno nosnico, nato pa so lahko po desetih minutah prejeli še en vpih, če bolečina ni bila zadostno ublažena.
Instanyl contains the active substance fentanyl.
Zdravilo Instanyl vsebuje učinkovino fentanil.
Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to relieve pain.
Fentanil začne z vstopom v krvni obtok delovati na receptorje v možganih in hrbtenjači ter tako olajša bolečino.
It must not be used in patients treated with medicines containing sodium oxybate (used to treat narcolepsy, a sleep disorder).
Ne smejo ga uporabljati niti bolniki, ki se zdravijo z zdravili, ki vsebujejo natrijev oksibat (uporablja se za zdravljenje narkolepsije, motnje spanja).
A patient's breakthrough pain was considered to have responded to treatment if there was a reduction of at least 2 points.
Kot bolnik, ki se je odzval na zdravljenje, je bil opredeljen bolnik s prebijajočo bolečino, pri katerem je prišlo do zmanjšanja bolečine za vsaj dve točki.
The reduction in pain intensity after 10 minutes was between 1.8 and 2.7 points on an 11-point pain scale for patients who took Instanyl, compared with 1.4 for patients who took placebo.
Zmanjšanje intenzivnosti bolečine po desetih minutah, ocenjene na podlagi 11-točkovne bolečinske lestvice, je bilo pri bolnikih, ki so prejeli zdravilo Instanyl, med 1,8 in 2,7 točke, pri bolnikih, ki so prejeli placebo, pa 1,4 točke.
The number of breakthrough pain episodes that responded to treatment was also higher among patients who received Instanyl than those who received placebo.
Število epizod prebijajoče bolečine, pri katerih je prišlo do odziva na zdravljenje, je bilo višje pri bolnikih, ki so prejemali zdravilo Instanyl, kot pri bolnikih, ki so prejemali placebo.
It must also not be used in patients who have had facial radiotherapy (treatment with radiation to the face) or who have recurrent episodes of epistaxis (nosebleeds).
Prav tako ga ne smejo uporabljati bolniki, ki so pred tem imeli radioterapijo (zdravljenje z obsevanjem) v predelu obraza, ali bolniki s ponavljajočimi se epizodami krvavitev iz nosu.
Instanyl is a medicine used to treat breakthrough pain in adults with cancer.
Zdravilo Instanyl se uporablja za zdravljenje prebijajoče bolečine pri odraslih bolnikih z rakom.
It must not be used to treat short-term pain other than breakthrough pain.
Zdravilo se lahko uporablja samo za zdravljenje prebijajoče bolečine, ne sme pa se uporabljati za zdravljenje drugih vrst kratkotrajnih bolečin.
The change in pain intensity after 10 minutes was between 2.0 and 2.7 points after receiving doses of Instanyl compared with 1.3 after receiving placebo.
Sprememba intenzivnosti bolečine po desetih minutah je bila pri bolnikih, ki so prejemali odmerke zdravila Instanyl, med 2,0 in 2,7 točke, pri bolnikih, ki so prejemali placebo, pa 1,3 točke.
Each patient then used the identified dose of Instanyl or placebo to treat breakthrough pain.
Za zdravljenje prebijajoče bolečine je nato vsak bolnik uporabljal tako določeni odmerek zdravila Instanyl ali placebo.
How does Instanyl work?
Kako zdravilo Instanyl deluje?
The number of patients who responded to treatment was also higher in the Instanyl group than in the placebo group.
Tudi število bolnikov, ki so se odzvali na zdravljenje, je bilo višje pri bolnikih, ki so prejeli zdravilo Instanyl, v primerjavi z bolniki, ki so prejeli placebo.
For the full list of side effects with Instanyl, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Instanyl, glejte navodilo za uporabo.
For more information about using Instanyl, see the package leaflet or contact your doctor or pharmacist.
Bolnik lahko prejme zdravilo Instanyl za največ štiri epizode prebijajoče bolečine na dan. Za več informacij glede uporabe zdravila Instanyl glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is increased as necessary until reaching the dose that gives the patient adequate pain relief.
Prvi odmerek zdravila Instanyl je 50 mikrogramov (en vpih pršila najmanjše jakosti) v eno nosnico.
In Instanyl, fentanyl is contained inside a nasal spray.
Zdravilo Instanyl vsebuje fentanil v obliki pršila za nos.
Patients taking Instanyl were allowed to take a second spray 10 minutes after the first dose if there had been insufficient pain relief.
Če olajšanje bolečine pri bolnikih, ki so jemali zdravilo Instanyl, ni bilo zadostno, so ti lahko deset minut po prvem odmerku prejeli še drugega.
Annex IV Conditions for lifting the suspension
Priloga IV Pogoji za preklic začasnega umika
The new formulation must be approved by the National Competent Authorities of the concerned Member States.
Novo formulacijo morajo odobriti pristojni nacionalni organi zadevnih držav članic.
Evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol.
Dokaz, da je bila formulacija zdravila spremenjena ter da ima ustrezen profil sproščanja z enakim profilom kakovosti, varnosti in učinkovitosti, kot ga ima trenutno odobrena formulacija, vendar brez klinično pomembne interakcije z alkoholom.
Only applicable to products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism
Velja le za zdravila, ki vsebujejo premaz iz polimetakrilat-trietilcitrata kot mehanizem za prirejeno sproščanje
For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom pristojnim nacionalnim organom predložiti naslednje:
Safety studies have shown that the strain is safe for turkeys.
Študije o varnosti so pokazale, da je sev varen za purane.
The full EPAR for Innovax-ILT can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Innovax-ILT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the EU for Innovax-ILT on 3 July 2015.
Evropska komisija je dovoljenje za promet z zdravilom Innovax-ILT, veljavno po vsej Evropski uniji, izdala 3. julija 2015.
In the future if the animals are exposed to a similar virus the immune system will be able to respond more quickly.
Če so živali kasneje izpostavljene podobnemu virusu, se lahko imunski sistem nanj hitreje odzove.
This is a summary of the European public assessment report (EPAR) for Innovax-ILT.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Innovax-ILT.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that InnovaxILT's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Innovax-ILT večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck.
Cepivo se lahko daje piščancem, starim en dan, z enkratnim injiciranjem pod kožo na vratu.
The disease is caused by a herpesvirus and can be mild (causing watery eyes, nasal discharge and mild inflammation of the windpipe) or severe, causing dyspnoea (difficulty breathing), respiratory depression and coughing up of blood.
Bolezen povzroča herpes virus in je lahko blaga (povzroči solzenje, izcedek iz nosu in blago vnetje sapnika) ali huda, pri čemer povzroči dispnejo (oteženo dihanje), respiratorno depresijo in izkašljevanje krvi.
ILT is an infection of the airways which may affect growth and decrease egg production in chickens.
ILT je okužba dihalnih poti, ki lahko vpliva na rast in zmanjša nastajanje jajc pri kokoših.
It is not intended to provide practical advice on how to use Innovax-ILT.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The withdrawal period for meat and eggs from chickens treated with Innovax-ILT is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za meso in jajca piščancev, zdravljenih z zdravilom Innovax-ILT, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Other information about Innovax-ILT
Druge informacije o zdravilu Innovax-ILT
When Innovax-ILT is given to chickens, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against it.
Ko piščanci prejmejo cepivo Innovax-ILT, imunski sistem živali prepozna virus kot „tujek“ ter začne proti njemu tvoriti protitelesa.
Avian infectious laryngotracheitis and Marek's disease vaccine (live recombinant)
cepivo proti aviarnemu infekcijskemu laringotraheitisu in Marekovi bolezni (živo, rekombinantno)
Chickens become infected at an early age via inhalation of dander (flakes of skin) containing the virus which can remain infectious for several months after being shed from the body.
Piščanci se okužijo v zgodnjem življenjskem obdobju z vdihavanjem prhljaja (delčkov kože), ki vsebuje virus in je lahko kužen še več mesecev po tem, ko odpade s telesa.
Innovax-ILT is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Zdravilo Innovax-ILT je na voljo v obliki suspenzije in vehikla za pripravo suspenzije za injiciranje in se izdaja le na recept.
What is Innovax-ILT and what is it used for?
Kaj je zdravilo Innovax-ILT in za kaj se uporablja?
The turkey herpesvirus strain HVT/ILT-138 has been modified so that it will produce the glycoproteins gD and gI which form part of the outer coat of the ILT virus.
Sev puranjega herpes virusa HVT/ILT-138 je bil spremenjen tako, da tvori glikoproteina gD in gI, ki sestavljata zunanjo ovojnico virusa ILT.
What benefits of Innovax-ILT have been shown in studies?
Kakšne koristi je zdravilo Innovax-ILT izkazalo v študijah?
Innovax-ILT is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which is closely related to MD virus but does not cause disease in chickens.
Innovax-ILT je cepivo, ki vsebuje serotip 3 puranjega herpes virusa, tj. vrsto herpes virusa, ki je tesno povezan z virusom Marekove bolezni, vendar pri piščancih ne povzroča bolezni.
What are the risks associated with Innovax-ILT?
Kakšna tveganja so povezana z zdravilom Innovax-ILT?
Since Innovax-ILT is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Cepivo Innovax-ILT je živo cepivo, zato se sev cepiva izloča iz cepljenih ptic in se lahko razširi na purane.
Chickens were taken from the field trial and challenged (exposed to infection) in the laboratory to demonstrate protection after vaccination.
Piščance iz terenskega preskušanja so nato prenesli v laboratorij, kjer so izvedli provokacijski test (jih izpostavili okužbi), da bi dokazali, da se je po cepljenju razvila zaščita.
Innovax-ILT contains live turkey herpesvirus strain HVT/ILT-138.
Zdravilo Innovax-ILT vsebuje sev živega puranjega herpes virusa HVT/ILT-138.
Why is Innovax-ILT approved?
Zakaj je bilo zdravilo Innovax-ILT odobreno?
Protection against ILT starts 4 weeks after vaccination and lasts 60 weeks.
Zaščita pred infekcijskim laringotraheitisom se razvije štiri tedne po cepljenju in traja 60 tednov.
To evaluate the effects of the vaccine against MD, chickens vaccinated either with Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac (a vaccine which also protects against Marek's disease) were infected with very virulent strains of the MD virus.
Da bi ovrednotili učinke cepiva proti Marekovi bolezni, so piščance, cepljene bodisi zgolj s cepivom Innovax-ILT bodisi s cepivom Innovax-ILT v kombinaciji s cepivom Nobilis Rismavac (cepivom, ki prav tako ščiti pred Marekovo boleznijo), okužili z zelo virulentnimi sevi virusa Marekove bolezni.
The level of protection in general was higher when Innovax-ILT was given alone.
Stopnja zaščite je bila na splošno višja po cepljenju zgolj s cepivom Innovax-ILT.
MD is another herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Marekova bolezen je prav tako okužba s herpes virusom, ki prizadene piščance in lahko povzroči paralizo kril in nog ter nastanek tumorjev v različnih organih.
For more information about treatment with Innovax-ILT, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Innovax-ILT naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ILT, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
V povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
For practical information about using Innovax-ILT, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Innovax-ILT naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Innovax-ILT is a veterinary vaccine used to protect chickens against infectious laryngotracheitis (ILT) and Marek's disease (MD).
Innovax-ILT je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito piščancev pred infekcijskim laringotraheitisom (ILT) in Marekovo boleznijo (MB).
A field trial in chickens was performed to evaluate the effects of the vaccine against ILT and MD. Mortality was low, no disease related signs were observed and the condition of the chickens was good throughout the trial, indicating effectiveness of the vaccine.
Umrljivost je bila majhna, opazili niso nobenih z boleznijo povezanih znakov in tudi stanje piščancev je bilo skozi celotno preskušanje dobro, kar kaže na to, da je cepivo učinkovito.
In a second challenge study the effectiveness of the vaccination with Innovax-ILT alone and InnovaxILT mixed with Nobilis Rismavac was also examined by evaluation of protection after infection under laboratory conditions with the ILT virus.
V drugi provokacijski študiji so učinkovitost cepljenja zgolj s cepivom Innovax-ILT in s cepivom Innovax-ILT v kombinaciji s cepivom Nobilis Rismavac raziskali tudi tako, da so ovrednotili zaščito po okužbi z virusom ILT v laboratorijskih pogojih.
When Innovax-ILT was applied mixed with Nobilis Rismavac, the start of protection against ILT was delayed by up to 10 weeks after vaccination.
Po dajanju cepiva Innovax-ILT v kombinaciji s cepivom Nobilis Rismavac se je zaščita pred ILT razvila kasneje, in sicer do 10 tednov po cepljenju.
How does Innovax-ILT work?
Kako zdravilo Innovax-ILT deluje?
How is Innovax-ILT used?
Kako se zdravilo Innovax-ILT uporablja?
When Innovax-ILT is given mixed with Nobilis Rismavac protection against MD starts at 5 days after vaccination.
Pri uporabi cepiva Innovax-ILT v kombinaciji s cepivom Nobilis Rismavac se zaščita pred Marekovo boleznijo razvije peti dan po cepljenju.
This will help protect the chickens against ILT and MD.
To pomaga zaščititi piščance pred infekcijskim laringotraheitisom in Marekovo boleznijo.
Chickens showed varying levels of protection after vaccination with either Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac.
Po cepljenju bodisi zgolj s cepivom Innovax-ILT bodisi s cepivom Innovax-ILT v kombinaciji s cepivom Nobilis Rismavac so pri piščancih opazili različne stopnje zaščite.
Chickens showed significant protection after both vaccination with Innovax-ILT alone and Innovax-ILT mixed with Nobilis Rismavac.
Tako po cepljenju zgolj s cepivom Innovax-ILT kot s cepivom Innovax-ILT v kombinaciji s cepivom Nobilis Rismavac so pri piščancih opazili znatno zaščito.
It is available as tablets (50, 100, 200, 300 and 400 mg).
Na voljo je v obliki tablet (50, 100, 200, 300 in 400 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Trobalt on 28 March 2011.
Evropska komisija je dovoljenje za promet z zdravilom Trobalt, veljavno po vsej Evropski uniji, odobrila dne 28. marca 2011.
The full EPAR for Trobalt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trobalt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In the other two studies, the main measure of effectiveness was the number of patients whose number of seizures was at least halved.
V drugih dveh študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih se je število napadov vsaj prepolovilo.
Other information about Trobalt
Druge informacije o zdravilu Trobalt
What measures are being taken to ensure the safe use of Trobalt?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Trobalt?
This is a summary of the European public assessment report (EPAR) for Trobalt.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trobalt.
In the first study, the main measure of effectiveness was the change in the number of seizures per month.
V prvi študiji je bilo glavno merilo učinkovitosti sprememba števila napadov na mesec.
What benefit has Trobalt shown during the studies?
Kakšne koristi je zdravilo Trobalt izkazalo med študijami?
This will stop further transmission of electrical impulses thereby preventing epileptic seizures.
To preprečuje nadaljnji prenos električnih signalov ter posledično epileptične napade.
The CHMP decided that the benefits of Trobalt are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Trobalt večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Epilepsy is caused by excessive electrical activity in the nerve cells of the brain.
Epilepsijo povzroča prekomerna električna aktivnost v živčnih celicah v možganih.
The recommended maintenance dose is between 600 mg a day and a maximum of 1,200 mg a day.
Priporočeni vzdrževalni odmerek znaša od 600 mg na dan do največ 1 200 mg na dan.
Treatment with Trobalt starts with one 100 mg tablet three times a day for one week; the dose is then increased weekly by 50 mg per dose according to the patient's response.
Zdravljenje z zdravilom Trobalt se začne z enotedenskim zdravljenjem z eno 100-miligramsko tableto trikrat na dan, nato pa se ta odmerek vsak teden poveča za 50 mg v skladu z bolnikovim odzivom.
For more information on how to use Trobalt, including detailed recommendations for different patients groups, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Trobalt, vključno s podrobnimi priporočili za posamezne skupine bolnikov, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
However, because of the risk of retinal discolouration, which could possibly result in impaired vision, the CHMP concluded that the use of Trobalt should be restricted only to those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.
Vendar je zaradi tveganja za spremembo barve mrežnice, zaradi česar bi lahko prišlo do okvare vida, zaključil, da je treba uporabo zdravila Trobalt omejiti le na tiste bolnike, pri katerih so se druga zdravila proti epilepsiji izkazala za nezadostna ali jih ne prenašajo.
It is used in epilepsy with or without ‘secondary generalisation' (when the excessive electrical activity reaches the whole brain).
Uporablja se pri epilepsiji s sekundarno generalizacijo (ko prekomerna električna aktivnost zajame celotne možgane) ali brez nje.
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 Trobalt.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Trobalt, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The effect of Trobalt at 600 mg a day was inconclusive in this study.
Učinka jemanja 600 mg zdravila Trobalt na dan s to študijo ni bilo mogoče ovrednotiti.
These are pores that let potassium move in and out of the cell and play a role in terminating electrical impulses.
Imajo obliko por, ki prepuščajo kalij v celico in iz nje ter imajo pomembno vlogo pri ustavljanju električnih signalov.
What is the risk associated with Trobalt?
Kakšna tveganja so povezana z zdravilom Trobalt?
The company that makes Trobalt must ensure that doctors who are expected to prescribe Trobalt receive an information pack containing important safety information, including information on the risk of pigment changes in the eye and discolouration of the nails, lips and skin, and on the need for a full eye examination at the start of treatment and at least every 6 months during treatment.
Družba, ki izdeluje zdravilo Trobalt, mora zdravnikom, ki bodo predpisovali zdravilo Trobalt, zagotoviti informativno gradivo, ki bo vsebovalo pomembne informacije o varnosti zdravila, vključno z informacijami o tveganju za pigmentne spremembe v očeh ter spremembo barve nohtov, ustnic in kože ter o nujnosti za temeljit pregled oči na začetku zdravljenja in vsaj vsakih šest mesecev med zdravljenjem.
For more information about treatment with Trobalt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Trobalt preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
To je vrsta epilepsije, pri kateri prevelika električna aktivnost v enem delu možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
Trobalt was more effective than placebo in reducing the number of seizures.
Zdravilo Trobalt je bilo pri zmanjševanju števila napadov učinkovitejše od placeba.