natgillin/translations-raw huggingface dataset:
Lenalidomide Celgene Europe was to be used in patients who were dependent on receiving blood transfusions to treat their anaemia and whose myelodysplastic syndromes were associated with a specific genetic mutation (deletion of part of chromosome number 5), and with a low to intermediate risk of progressing to leukaemia or death.
Zdravilo Lenalidomide Celgene Europe naj bi se uporabljalo pri bolnikih, ki morajo za zdravljenje anemije prejemati transfuzije krvi in pri katerih so mielodisplastični sindromi povezani s specifično gensko mutacijo (izgubo dela kromosoma št. 5) in ki so izpostavljeni majhnemu ali srednjemu tveganju za napredovanje bolezni v levkemijo ali za nastop smrti.
The active substance in Lenalidomide Celgene Europe, lenalidomide, is an immunomodulating agent.
Zdravilna učinkovina zdravila Lenalidomide Celgene Europe je lenalidomid, ki je imunomodulator.
What is Lenalidomide Celgene Europe?
Kaj je zdravilo Lenalidomide Celgene Europe?
How is Lenalidomide Celgene Europe expected to work?
Kako naj bi zdravilo Lenalidomide Celgene Europe delovalo?
What was Lenalidomide Celgene Europe expected to be used for?
Za kaj naj bi se zdravilo Lenalidomide Celgene Europe uporabljalo?
In particular, because the study did not compare the medicine to any other treatment, it was difficult to determine if treatment with Lenalidomide Celgene Europe increased the risk of progression to acute myeloid leukaemia.
Presoja, ali zdravljenje z zdravilom Lenalidomide Celgene Europe poveča tveganje za napredovanje bolezni v akutno mieloidno levkemijo, je bila otežena zlasti zato, ker študija ni primerjala zdravila z nobenim drugim zdravljenjem.
--1 Live attenuated Muscovy duck parvovirus ≥ 2.6 log10 CCID50 * * Cell culture infectious dose 50%
--1 Atenuiran parvovirus rac moškatnih bleščavk, sev GM 199 ≥2,6 log10 CCID50* (*) 50% infektivni odmerek za celično kulturo
EU (MA) Number
EU številka
Suspension and diluent for suspension for injection
Suspenzija in vehikel za
10 vials Not applicable
1 viala Ni smiselno
Not applicable
Ni smiselno
Muscovy ducks
Race moškatne
This summary was last updated in 12-2016.
Povzetek je bil nazadnje posodobljen 12-2016.
The percentages of successful injections for the two groups were around 30% and 9%, respectively.
Odstotek uspešnih injiciranj v obeh skupinah je bil okoli 30 % oziroma 9 %.
The European Commission granted a marketing authorisation valid throughout the European Union for Relistor on 2 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Relistor, veljavno po vsej Evropski uniji, izdala 2. julija 2008.
The full EPAR for Relistor 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 Relistor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
These side effects are generally mild or moderate.
Ti neželeni učinki so bili običajno blagi ali zmerni.
This is a summary of the European public assessment report (EPAR) for Relistor.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Relistor.
The dose depends on the patient's body weight.
Odmerek je odvisen od bolnikove telesne mase.
These receptors are also found in the gut.
Ti receptorji so prisotni tudi v črevesju.
What measures are being taken to ensure the safe and effective use of Relistor?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Relistor?
The Agency's Committee for Medicinal Products for Human Use decided that Relistor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Relistor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Relistor
Druge informacije o zdravilu Relistor
This means that it blocks a specific type of opioid receptor called the ‘mu-opioid receptor'.
To pomeni, da zavira posebno vrsto opioidnih receptorjev, imenovanih muopioidni receptorji.
It is not intended to provide practical advice on how to use Relistor.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In patients not on palliative care, Relistor is given as an injection under the skin at a dose of 12 mg once a day, for at least 4 days per week and up to 7 days per week as needed; treatment with usual laxatives should be stopped when starting Relistor.
Pri bolnikih, ki ne prejemajo paliativne oskrbe, se zdravilo Relistor daje z injiciranjem v podkožje v odmerku 12 mg enkrat na dan, vsaj štirikrat na teden in največ sedem dni na teden, če je to potrebno; zdravljenje z običajnimi odvajalnimi zdravili je treba pred začetkom jemanja zdravila Relistor prenehati.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relistor have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Relistor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Relistor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Relistor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal pain (stomach ache), nausea (feeling sick), diarrhoea and flatulence.
Najpogostejši neželeni učinki zdravila Relistor (opaženi pri več kot 1 bolniku od 10) so abdominalne (trebušne) bolečine, navzeja (slabost), driska in napenjanje (vetrovi).
What is Relistor and what is it used for?
Kaj je zdravilo Relistor in za kaj se uporablja?
What benefits of Relistor have been shown in studies?
Kakšne koristi je zdravilo Relistor izkazalo v študijah?
Relistor methylnaltrexone bromide
Relistor metilnaltreksonijev bromid
What are the risks associated with Relistor?
Kakšna tveganja so povezana z zdravilom Relistor?
By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects.
Z zaviranjem teh receptorjev zdravilo Relistor zmanjšuje zaprtje zaradi opioidov, vendar ne vpliva na njihovo protibolečinsko delovanje.
Methylnaltrexone bromide is less able to enter the brain than naltrexone, meaning that it blocks the mu-opioid receptors in the gut but not in the brain.
Metilnaltreksonijev bromid slabše prehaja v možgane kot naltrekson, kar pomeni, da zavira muopioidne receptorje v črevesju, ne pa tudi v možganih.
Why is Relistor approved?
Zakaj je bilo zdravilo Relistor odobreno?
For practical information about using Relistor, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Relistor naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Relistor must not be used in patients whose bowel is blocked, who are at risk of recurrent bowel blockage or who have a condition that needs immediate bowel surgery.
Zdravilo Relistor se ne sme uporabljati pri bolnikih, ki imajo obstrukcijo prebavil, pri katerih obstaja nevarnost za ponovitev obstrukcije prebavil, ali bolnikih z obolenjem, ki zahteva takojšnji kirurški poseg na prebavilih.
Relistor has also been compared with placebo in a third study involving 496 patients with constipation caused by opioids, but no advanced illness.
Zdravilo Relistor so s placebom primerjali tudi pri 496 bolnikih, ki so bili zaprti zaradi jemanja opioidov, a niso imeli napredovale bolezni.
Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique).
Zdravilo Relistor ni priporočljivo za bolnike, ki imajo hude težave z ledvicami, zaradi česar potrebujejo dializo (tehniko čiščenja krvi).
The main measures of effectiveness were the number of patients who had a bowel movement within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so blato odvedli v štirih urah po prvem odmerku, in delež injekcij, ki so uspešno pospešile odvajanje blata.
Patients can inject Relistor themselves once they have been trained appropriately.
Bolniki si lahko po ustreznem usposabljanju zdravilo Relistor injicirajo sami.
It is available as a solution for injection in vials or in prefilled syringes.
Na voljo je v obliki raztopine za injiciranje v vialah ali napolnjenih brizgah.
The main measure of effectiveness in both studies was the number of patients who had a bowel movement within four hours of the first dose.
Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, ki so odvedli blato v štirih urah po prvem odmerku.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Metilnaltreksonijev bromid se pridobiva iz naltreksona, dobro znane učinkovine, ki se uporablja za zaviranje delovanja opioidov.
The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'.
Zdravilna učinkovina v zdravilu Relistor, metilnaltreksonijev bromid, je antagonist muopioidnih receptorjev.
Relistor is used to treat constipation caused by opioid painkillers (such as morphine) when laxative medicines have not worked well enough.
Relistor se uporablja za zdravljenje zaprtja, ki ga povzročajo opioidna zdravila za lajšanje bolečin (kot je na primer morfin), kadar je odziv na odvajalno zdravljenje nezadosten.
For the full list of all side effects reported with Relistor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Relistor, glejte navodilo za uporabo.
Relistor is usually injected under the skin of the upper legs, belly or upper arms.
Zdravilo Relistor se običajno injicira v podkožje stegna, trebuha ali nadlahti.
Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162).
Rezultati so pokazali, da je 34 % (102 od 298) bolnikov, ki so prejeli zdravilo Relistor, blato odvedlo v štirih urah po prvem injiciranju zdravila v primerjavi z 10 % (16 od 162) tistih, ki so prejeli placebo.
The second study also looked at the number of patients who had a bowel movement at least twice within four hours of the first four doses.
V drugi študiji so proučevali število bolnikov, pri katerih je do odvajanja blata prišlo vsaj dvakrat v štirih urah po prvih štirih odmerkih.
Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Opioidi lajšajo bolečine tako, da se vežejo na receptorje opioidov v možganih in hrbtenjači.
When opioids attach to the gut receptors, the mobility of the gut is reduced, leading to constipation.
Kadar se opioidi vežejo na receptorje v črevesju, se njegovo delovanje upočasni, kar povzroča zaprtje.
Relistor contains the active substance methylnaltrexone bromide.
Zdravilo Relistor vsebuje zdravilno učinkovino metilnaltreksonijev bromid.
In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Pri drugi študiji je 52 % (32 od 62) bolnikov, ki so prejeli zdravilo Relistor, odvedlo blato vsaj dvakrat v štirih urah po prvih štirih odmerkih v primerjavi z 8 % (6 od 71) bolnikov, ki so prejeli placebo.
In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines.
Zdravilo Relistor se pri bolnikih, ki prejemajo paliativno oskrbo (zdravljenje simptomov bolezni, ki pa ne vodi k ozdravitvi), injicira v podkožje vsak drugi dan poleg običajnih odvajalnih zdravil.
How does Relistor work?
Kako zdravilo Relistor deluje?
Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Skupni rezultati obeh študij kažejo, da je 55 % (91 od 165) bolnikov, ki so prejeli zdravilo Relistor, odvajalo blato v štirih urah po prvem injiciranju v primerjavi s 15 % (18 od 123) bolnikov, ki so prejeli placebo.
Relistor can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Relistor je le na recept.
Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids.
Zdravilo Relistor se je v dveh glavnih študijah, v kateri je bilo vključenih skupaj 288 bolnikov z napredovalo boleznijo in zaprtjem, ki ga povzroča jemanje opioidov, izkazalo za učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri pospeševanju odvajanja blata.
How is Relistor used?
Kako se zdravilo Relistor uporablja?
The dose of Relistor should be reduced in patients who have severe kidney problems.
Pri bolnikih, ki imajo težko ledvično okvaro, je treba odmerek zdravila Relistor prilagoditi.
Key elements to be included in the educational material
Ključni elementi, ki morajo biti vključeni v izobraževalnem materialu
• Information on the identified and potential risks.
• informacije o znanih in možnih nevarnostih.
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Imetnik dovoljenja za promet z zdravilom (MAH) se mora z nacionalnimi pristojnimi organi dogovoriti o podrobnostih izobraževalnega programa in mora ta program uvesti nacionalno, s čimer bo zagotovil, da bodo pred začetkom predpisovanja vsi zdravniki prejeli paket z zdravstvenimi profesionalnimi informacijami, ki bo vseboval:
• Educational material
• izobraževalni material,
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
• povzetek glavnih značilnosti zdravila (SPC) in navodilo za uporabo in označevanje.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Države članice morajo zagotoviti, da bodo izpolnjeni vsi pogoji ali uveljavljene vse omejitve za varno in učinkovito uporabo spodaj opisanih zdravil:
• Information on gel depot formation and possible injections site reactions
• informacije o oblikovanju gelskega depoja in možnih reakcijah na mestu injiciranja,
• Instructions for administration
• navodila za uporabo,
• Posology
• odmerjanje,
The Reference Member States were Germany, Hungary, Norway, Poland, Slovakia, Spain, United Kingdom.
Zadevne države članice so bile Nemčija, Madžarska, Norveška, Poljska, Slovaška, Španija in Združeno kraljestvo.
1 Article 29(2) of Directive 2001/83/EC, as amended.
1 Člen 29(2) Direktive 2001/83/ES, kot je bila spremenjena.
The CHMP appointed Dr. J.F.F.
CHMP je imenoval dr. J.F.F.
The final opinion was converted into a Decision by the European Commission on 11/10/2006.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 11/10/2006.
Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur.
Lekkerkerkerja (Nizozemska) za poročevalca in dr. Hudsona (Združeno kraljestvo) za soporočevalca.
A positive opinion was adopted 28 June 2006.
Pozitivno mnenje je bilo sprejeto 28. junija 2006.
The Mutual Recognition Procedure started on 21 October 2005.
Postopek za medsebojno priznavanje se je začel 21. oktobra 2005.
The Denmark referred the reasons for disagreement to the EMEA on 31 March 2006.
Danska je agenciji EMEA posredovala razloge za nesoglasje dne 31. marca 2006.
These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Omenjene države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
The arbitration procedure started on 27 April 2006.
Arbitražni postopek se je začel 27. aprila 2006.
During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
The scope of the referral was to agree whether Doxazosin “Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (Doxazosin) is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
Winthrop Pharmaceuticals UK Ltd submitted applications for mutual recognition of Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Družba Winthrop Pharmaceuticals UK Ltd je podala vloge za medsebojno priznavanje zdravila Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.
Supplementary information was provided by the Marketing Authorisation Holder on 23 May 2006.
Imetnik dovoljenja za promet z zdravilom je predložil dodatne informacije dne 23. maja 2006, ustna pojasnila pa je podal 27. junija 2006.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Doxazosin “Winthrop” 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
The study should be based on an agreed protocol.
Študija mora temeljiti na dogovorjenem protokolu.
Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017
Datum prve odobritve: 15. november 2012 Datum zadnjega podaljšanja: 13. julij 2017
The level of efficacy varied between the individual anatomical locations.
Raven učinkovitosti se je razlikovala med posameznimi anatomskimi lokacijami.
No overall differences in safety or efficacy were observed between younger and older patients.
Med mlajšimi in starejšimi bolniki niso opazili splošnih razlik v varnosti ali učinkovitosti.
8 weeks after randomisation
8 tednov po randomizaciji
Results demonstrated no systemic absorption.
Rezultati niso pokazali sistemske absorpcije.
The final study report shall be submitted:
Končno poročilo študije je treba predložiti do:
Long term efficacy
Dolgoročna učinkovitost
to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
do < 1/1.000); zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This leaflet was last revised in.
Navodilo je bilo nazadnje revidirano .
Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age.
Aktinična keratoza se ne pojavlja pri otrocih, zato tega zdravila ne smete uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Local skin responses
Lokalni odzivi kože
d p<0.001; compared to vehicle by logistic regression with treatment, study and anatomical location.
d p < 0,001; v primerjavi z vehiklom glede na logistično regresijo z zdravljenjem, študijo in anatomsko umestitvijo.
Contact your doctor if these local skin reactions get severe.
Obrnite se na svojega zdravnika, če te lokalne kožne reakcije postanejo hude.
The tube is for single use only and should be discarded after use (see section 6.6).
Tuba je namenjena samo enkratni uporabi, zato jo po uporabi zavrzite (glejte poglavje 6.6).
gel 2 tubes
gel 2 tubi
Patients were followed every 3 months for 12 months (see table 5).
Bolnike so spremljali 12 mesecev vsake 3 mesece (glejte preglednico 5).
Back of Hand
Roka Hrbtni del dlani
- If you are allergic to ingenol mebutate or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na ingenolmebutat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Wash the area with soap and water.
Umijte mesto z milom in vodo.
- Do not apply more gel than your doctor has advised.
- Ne nanašajte več gela, kot vam je naročil zdravnik.
Treatment effect may not be adequately assessed until resolution of local skin responses.
Učinka zdravljenja morda ne bo mogoče ustrezno oceniti, dokler se ne pozdravijo lokalni odzivi kože.
- Allow the area to dry for 15 minutes.
- Počakajte 15 minut, da se posuši.
At 12 months, the complete clearance rates in these groups were 31% and 19% respectively.
V 12. mesecu sta bili stopnji popolne ozdravitve v teh skupinah 31 % in 19 %.
If you have been prescribed two different strengths for treatment of two different areas you should make sure that you use the prescribed strength on the correct area.
Če so vam predpisali dve različni jakosti gela za zdravljenje na dveh različnih mestih, morate poskrbeti, da boste uporabljali predpisano jakost na pravem mestu.