FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Slovenian: Albert-SchweitzerGasse 3, 1140 WIEN, Avstrija µg/h transdermales Matrixpflaster vsebuje 4,125 mg fentanila (ustreza hitrosti sproščanja učinkovine 25 mikrogramov/h)
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Slovenian: (glejte poglavje 4.8).
English: London, 23 October 2007 EMEA/338591/2007
Slovenian: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanija
English: Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Slovenian: V tem smislu je CHMP sprejel indikacijo „Huda kronična bolečina, ki jo je mogoče ustrezno obvladati le z opioidnimi analgetiki“.
English: Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Slovenian: Znaki zastrupitve so globoka sedacija, ataksija, mioza, epileptični napadi in respiratorna depresija, ki je najpomembnejši simptom.
English: Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Slovenian: Fentanyl ratiopharm 25 µg/uur, pleister voor transdermaal gebruik Velika Britanija Telfanyl 25 microgram/hr Transdermal patch
English: During their July 2007 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 Fentanylratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, that the objections raised by France 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.
Slovenian: Glede shem za odmerjanje za prehod z drugih analgetikov, ki so na voljo v povzetku glavnih značilnosti zdravila za prehod s peroralnega morfina na transdermalni fentanil je CHMP na podlagi razpoložljivih podatkov izoblikoval mnenje, da je treba v povzetku glavnih značilnosti zdravila (tabela 4.2) navesti obe tabeli: konzervativno shemo za prehod (150:1), navedeno v obstoječem povzetku glavnih značilnosti zdravila za zdravilo Fentanyl ratiopharm za bolnike, ki potrebujejo rotacijo opioidov, ter shemo za prehod 100:1 (Donnerjevo tabelo) za bolnike s stabilnim zdravljenjem z opioidi, ki ga bolniki dobro prenašajo.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names International Non-Proprietary Name (INN): fentanyl
Slovenian: NAVODILO ZA UPORABO Fentanyl-ratiopharm 25 µg/h Matrixpflaster in povezana imena (glejte dodatek I) [Glejte Dodatek I - Izpolni država članica] fentanil
English: The final opinion was converted into a Decision by the European Commission on 23 October 2007.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: The Reference Member State was Germany and the Concerned Member States were Austria, France, the Netherlands, Spain and the United Kingdom.
Slovenian: Spanija ratiopharm España, S.A.
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur was Dr Eric Abadie.
Slovenian: tahikardija, bradikardija
English: The majority of these reactions were mild or moderate.
Slovenian: Večina teh reakcij je bila blagih ali zmernih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Revestive, veljavno po vsej Evropski uniji, izdala 30. avgusta 2012.
English: The company will provide more data about the medicine's safety from a registry of patients.
Slovenian: Družba bo zagotovila več podatkov o varnosti zdravila iz registra bolnikov.
English: If a benefit is not observed, treatment should be stopped.
Slovenian: Če ni prišlo do izboljšanja, je treba zdravljenje prekiniti.
English: What measures are being taken to ensure the safe and effective use of Revestive?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Revestive?
English: Revestive teduglutide
Slovenian: Revestive teduglutid
English: Patients or their carers can inject the medicines once they have received adequate training.
Slovenian: Bolniki ali njihovi negovalci lahko zdravilo injicirajo sami, ko so bili za to ustrezno usposobljeni.
English: Furthermore, Revestive showed an acceptable safety profile.
Slovenian: Poleg tega je bilo dokazano, da ima zdravilo Revestive sprejemljiv varnostni profil.
English: It is not intended to provide practical advice on how to use Revestive.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Other information about Revestive
Slovenian: Druge informacije o zdravilu Revestive
English: This is a summary of the European public assessment report (EPAR) for Revestive.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Revestive.
English: What are the risks associated with Revestive?
Slovenian: Kakšna tveganja so povezana z zdravilom Revestive?
English: What is Revestive and what is it used for?
Slovenian: Kaj je zdravilo Revestive in za kaj se uporablja?
English: The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini je zato zaključil, da so koristi zdravila Revestive večje od z njim povezanih tveganj, in priporočil, naj se zanj izda dovoljenje za promet.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Revestive je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revestive have also 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 Revestive upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: It must not be used in patients who have had a gastrointestinal cancer (cancer of the stomach, gut or liver) in the last five years.
Slovenian: Ne smejo ga uporabljati bolniki, ki so v zadnjih petih letih imeli raka prebavil (želodca, črevesa ali jeter).
English: The most commonly reported side effects with Revestive (which may occur in more than 1 in 10 patients) were respiratory tract infections (infections of the throat, sinuses, airways or lungs), headache, belly ache and swollen stomach, nausea, vomiting, and reddening, pain or swelling at the site of the injection.
Slovenian: Najpogostejši neželeni učinki zdravila Revestive (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe dihal (okužba žrela, sinusov, dihalnih poti ali pljuč), glavobol, bolečine v trebuhu in napet trebuh, navzeja, bruhanje ter pordelost, bolečina ali oteklina na mestu injiciranja.
English: In a second study in children, 53% (8 out of 15) of those who received Revestive had their parenteral nutrition at 12 weeks reduced by at least a tenth, while none (0 out of 5) of the patients who received a standard treatment achieved the same.
Slovenian: V drugi študiji se je pri 53 % (8 od 15) otrok, ki so prejemali zdravilo Revestive, količina parenteralne prehrane po 12 tednih zmanjšala za vsaj desetino, medtem ko se to ni zgodilo pri nobenem (0 od 5) bolniku, ki so prejemali standardno zdravljenje.
English: Why is Revestive approved?
Slovenian: Zakaj je bilo zdravilo Revestive odobreno?
English: What benefits of Revestive have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Revestive izkazalo v študijah?
English: In one study in adults, 63% (27 out of 43) of those who received Revestive had their parenteral nutrition at 20 weeks reduced by at least a fifth and maintained this reduced intake at 24 weeks.
Slovenian: V eni študiji pri odraslih se je pri 63 % (27 od 43) bolnikov, ki so prejemali zdravilo Revestive, količina parenteralne prehrane po 20 tednih zmanjšala za vsaj petino, pri čemer se je zmanjšani vnos ohranil tudi po 24 tednih.
English: Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above.
Slovenian: Revestive je zdravilo za zdravljenje sindroma kratkega črevesa pri odraslih in otrocih, starejših od enega leta.
English: The medicine can only be obtained with a prescription, and treatment should be started under the supervision of a doctor with experience in treating short bowel syndrome.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje zdravljenjem sindroma kratkega črevesa.
English: For more information about treatment with Revestive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Revestive preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s zdravnikom ali farmacevtom.
English: Patients who need high volumes of parenteral nutrition may benefit from a significant reduction, whereas patients in need of low amounts may have the chance to be weaned off completely.
Slovenian: Bolniki, ki potrebujejo velike količine parenteralne prehrane, bodo mogoče te potrebovali znatno manj, pri bolnikih, ki potrebujejo majhne količine, pa bo mogoče možna popolna ukinitev tovrstne prehrane.
English: Because the number of patients with the condition is low, the disease is considered ‘rare', and Revestive was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Slovenian: Ker je bolnikov s sindromom kratkega črevesa malo, velja ta bolezen za redko, zato je bilo zdravilo Revestive 11. decembra 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Revestive must not be used in patients who have, or are suspected to have, cancer.
Slovenian: Zdravilo Revestive se ne sme uporabljati pri bolnikih, ki imajo raka oziroma pri katerih obstaja sum, da ga imajo.
English: Revestive has been shown in 2 studies to reduce the amount of parenteral nutrition that patients need.
Slovenian: V dveh študijah je bilo ugotovljeno, da zdravilo Revestive zmanjšuje količino parenteralne prehrane, ki jo bolniki potrebujejo.
English: Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition).
Slovenian: Bolniki s sindromom kratkega črevesa običajno prejmejo hranila z infuzijo neposredno v vene (parenteralna prehrana).
English: The full EPAR for Revestive 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 Revestive je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In addition, patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine) commonly experienced complications, such as swelling of the stoma.
Slovenian: Poleg tega je pri bolnikih s stomo (umetno odprtino na sprednji strani trebuha za zbiranje blata in urina iz telesa) pogosto prišlo do zapletov, kot je oteklina stome.
English: The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP-2), a hormone made in the gut that increases absorption of nutrients from the intestine.
Slovenian: Zdravilna učinkovina v zdravilu Revestive, teduglutid, je podobna človeškemu glukagonu podobnemu peptidu 2 (GLP-2), tj. hormonu, ki se tvori v črevesu in povečuje absorpcijo iz črevesa.
English: Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine.
Slovenian: Teduglutid deluje podobno kot GLP-2 in povečuje absorpcijo iz črevesa tako, da poveča pretok krvi v črevo in iz njega, zmanjša hitrost, s katero hrana potuje po njem, ter zmanjša izločanje želodčne kisline, ki lahko ovira absorpcijo v črevesu.
English: For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Revestive naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
Slovenian: Sindrom kratkega črevesa je motnja, pri kateri črevo hranilnih snovi in tekočine ne absorbira pravilno, do česar običajno pride po kirurški odstranitvi velikega dela tankega črevesa.
English: Revestive contains the active substance teduglutide.
Slovenian: Zdravilo Revestive vsebuje zdravilno učinkovino teduglutid.
English: Revestive is given as an injection under the skin of the abdomen.
Slovenian: Zdravilo Revestive se daje z injiciranjem pod kožo trebuha.
English: This compares with 30% (13 out of 43) of those given placebo (a dummy treatment).
Slovenian: Ta delež je pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine), znašal 30 % (13 od 43).
English: Studies show that Revestive is beneficial for patients with short bowel syndrome as it significantly reduces the amount of parenteral nutrition they need.
Slovenian: Študije so pokazale, da je zdravilo Revestive koristilo bolnikom s sindromom kratkega črevesa, saj je pomembno pripomoglo k zmanjšanju količine parenteralne prehrane.
English: For the full list of all side effects reported with Revestive, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Revestive, glejte navodilo za uporabo.
English: Teduglutide has the advantage of lasting longer than GLP-2 in the body.
Slovenian: Njega prednost v primerjavi z GLP-2 je, da se v telesu obdrži dlje.
English: The recommended dose is 0.05 mg per kilogram body weight once a day, with the daily dose reduced by half in patients with moderate or severely reduced kidney function.
Slovenian: Priporočeni odmerek znaša 0,05 mg na kilogram telesne mase enkrat na dan.
English: How is Revestive used?
Slovenian: Kako se zdravilo Revestive uporablja?
English: How does Revestive work?
Slovenian: Kako zdravilo Revestive deluje?
English: The protocol shall be submitted to the National Competent Authorities:
Slovenian: Protokol je treba predložiti pristojnim nacionalnim organom:
English: The final study report shall be submitted to the National Competent Authorities:
Slovenian: Končno poročilo o študiji se predloži nacionalnim pristojnim organom:
English: The educational materials should ensure that healthcare professionals and patients/carers are able to successfully administer the product based on the instructions in the product information.
Slovenian: Izobraževalna gradiva morajo zagotavljati, da bodo zdravstveni delavci in bolniki/negovalci sposobni uspešno uporabiti zdravilo v skladu z navodili v informacijah o zdravilu.
English: The Marketing Authorisation Holders of adrenaline auto-injectors shall submit to the National Competent Authorities a Risk Management Plan containing key elements as described in the CHMP assessment report (including educational materials).
Slovenian: Imetniki dovoljenj za promet z zdravilom za samoinjektorje adrenalina morajo nacionalnim pristojnim organom predložiti načrt obvladovanja tveganja, ki vsebuje ključne elemente, opisane v poročilu odbora CHMP o oceni (vključno z izobraževalnimi gradivi).
English: Each Marketing Authorisation Holder of adrenaline auto-injectors shall perform a PK/PD study to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via their adrenaline auto-injector device.
Slovenian: Vsak imetnik dovoljenja za promet z zdravilom za samoinjektorje adrenalina bo izvedel FK-/FD-študijo, s katero bi lahko pojasnili vpliv različnih dejvnikov na porazdelitev, izpostavljenost in aktivnost adrenalina, kadar se uporablja s samoinjektorjem adrenalina.
English: National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Slovenian: Pristojni nacionalni organi držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
English: Austria and Hungary
Slovenian: Avstrija in Madžarska
English: As above
Slovenian: Kot zgoraj
English: Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia
Slovenian: Belgija, Češka republika, Danska, Španija, Finska, Italija, Luksemburg, Nizozemska, Norveška, Poljska in Slovaška
English: The responses were submitted to the EMEA on 12 September 2006.
Slovenian: Odgovori so bili predloženi EMEA 12. septembra
English: Not known.
Slovenian: Niso znane.
English: In these cases take immediate contact to a doctor.
Slovenian: V takšnih primerih se takoj posvetujte z zdravnikom.
English: The variation between individual cows was 1-3 hours.
Slovenian: Razlika med posameznimi kravami je znašala 1 do 3 ure.
English: For generic applications bioequivalence must be demonstrated.
Slovenian: Za splošno uporabo je treba dokazati bioekvivalenco.
English: The bioavailability after per-oral dosing is about 76 %.
Slovenian: Biološka razpoložljivost po peroralnem odmerjanju je približno 76 %.
English: The reason for this was that the national competent authorities of Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the ground that the efficacy has not been sufficiently substantiated in the dossier.
Slovenian: Razlog za to je bilo mnenje nacionalnih pristojnih organov Belgije in Norveške, da lahko zdravilo predstavlja potencialno resno tveganje za zdravje živali, saj v dosjeju učinkovitost zdravila ni bila zadostno utemeljena.
English: No such studies have been conducted with cattle.
Slovenian: Podobnih študij na govedu niso opravili.
English: Do not use in animals which have completely lost their appetite because this could lead to insufficient absorption of ketoprofen.
Slovenian: Ne uporabite pri živalih, ki so v celoti izgubile apetit, ker to lahko privede do nezadostne absorbcije ketoprofena.
English: This is also the indication applied for at the start of the mutual recognition procedure (MRP).
Slovenian: Ta indikacija je tudi v vlogi za začetek postopka medsebojnega priznavanja (MRP).
English: There is no specific antidote.
Slovenian: Specifičnih protistrupov ni na voljo.
English: Rifen 2.4g As above
Slovenian: Rifen 2,4 g Kot zgoraj
English: However, given that the pharmacokinetic data allowed to optimise the dose (keeping overall exposure comparable between the two products), it is concluded that a bridge exists that allows wellestablished use to apply to Dolovet.
Slovenian: Vendar se glede na to, da so farmakokinetični podatki omogočili optimizacijo odmerka (z ohranjanjem primerljivosti celokupne izpostavljenosti med obema zdraviloma), lahko zaključi, da obstaja povezava, ki omogoča dobro utemeljeno uporabo zdravila Dolovet.
English: Although not all effects of ketoprofen are covered by thromboxane activity (ketoprofen also has lipooxygenase activity), thromboxane activity is a sensitive parameter, not only for evaluating inflammation in this experimental model, but also for allowing extrapolation to the field condition up to a certain point.
Slovenian: Čeprav vseh učinkov ketoprofena ne pokriva tromboksanska aktivnost (ketoprofen ima tudi lipooksigenazno aktivnost), je tromboksanska aktivnost občutljiv parameter ne samo za oceno vnetja v tem eksperimentalnem modelu temveč tudi za ekstrapolacijo terenskih pogojev do določene točke.
English: In cases of overdose symptomatic therapy should be given.
Slovenian: V primerih prevelikega odmerjanja uvedemo simptomatsko zdravljenje.
English: If one accepts that a bridge exists, then the clinical indications that exist for Ketofen, as evidence in the literature, should apply in large part to Dolovet.
Slovenian: Če sprejmemo, da obstaja povezava, potem morajo obstoječe klinične indikacije za Ketofen, dokazane v literaturi, v veliki meri veljati tudi za zdravilo Dolovet.
English: The experimental design of the study mimics an acute toxic mastitis.
Slovenian: Eksperimentalni načrt raziskave posnema akutni toksični mastitis.
English: 4..6 Adverse reactions (frequency and seriousness)
Slovenian: Neželeni učinki (pogostost in resnost)
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 3.8.2005 (revised2 10.11.2006)
Slovenian: 3.8.2005 (datum zadnje revizije: 10.11.2006)
English: However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”.
Slovenian: Vendar vlagatelj šteje raziskavo določitve odmerka, ki jo je predložil z odgovorom, kot ključno za oceno učinkovitosti: „Določitev peroralnega odmerka ketoprofena pri mastitisu pri kravah, sproženem z endotoksinom, Raziskava 06-131-LC, 7. avgust 2006“.
English: For example, in generic applications, a preclinical bridge is made that allows extrapolation to the field situation.
Slovenian: Npr. za splošno uporabo se vzpostavi predklinična povezava, ki omogoča ekstrapolacijo na terensko situacijo.
English: Even though equivalence has not been formally shown, the two products perform similarly when compared to placebo in regards to a number of critical parameters, both clinical and otherwise (thromboxane B2 levels in plasma).
Slovenian: Čeprav enakovrednost ni bila formalno dokazana, imata obe zdravili podobno učinkovitost v primerjavi s placebom glede na številne kritične parametre, tako klinične kot tudi drugačne parametre (ravni tromboksana B2 v plazmi).
English: The elimination half life after per oral administration was about 4,5 hours.
Slovenian: Razpolovni čas izločanja po peroralnem vnosu je znašal približno 4,5 ure.
English: Considering then the data provided and the well-established use of ketoprofen, CVMP is of the opinion that the following claim can be substantiated:
Slovenian: Na osnovi predloženih podatkov in dobro utemeljene uporabe ketoprofena CVMP meni, da obstajajo dokazi za naslednji zahtevek:
English: Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been demonstrated clearly enough.
Slovenian: Zniževanje pireksije oz. zvišane telesne temperature in lajšanje vnetja se štejeta za pomembna klinična zahtevka in ju je treba ohraniti v indikacijah, saj sta bila zadostno dokazana.