FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients with the complete deletion/large rearrangement genotype developed antibodies, and the majority of them (7/8) also tested positive for neutralizing antibodies on at least 3 consecutive occasions.
Slovenian: Vsi bolniki z genotipom s popolno delecijo/obsežno preureditvijo so razvili protitelesa in pri večini od njih (7/8) so bili testi za nevtralizirajoča protitelesa vsaj trikrat zaporedoma pozitivni.
English: Approximately half of the patients in the weekly treatment group (15 of 32; 47%) had left ventricular hypertrophy at baseline, defined as LVM index 103 g/m2.
Slovenian: V skupini, ki je prejemala tedensko zdravljenje, je imela na začetku študije približno polovica bolnikov (15 od 32; 47 %) hipertrofijo levega prekata, opredeljeno kot indeks LVM  103 g/m2.
English: Concentrate for solution for infusion 3 ml
Slovenian: Koncentrat za raztopino za infundiranje 3 ml
English: The recommended dose is an infusion of 0.5 mg (half a milligram) for every kg you weigh
Slovenian: Priporočeni odmerek je infundiranje 0,5 mg (pol miligrama) na kilogram telesne mase.
English: A total of 11 of 31 (36%) patients in the weekly treatment group versus 5 of 31 (16%) patients in the placebo group had an increase in FEV1 of at least 0.2 l at or before the end of the study, indicating a dose-related improvement in airway obstruction.
Slovenian: V skupini, ki je zdravljenje prejemala enkrat tedensko, so pri skupno 11 od 31 (36 %) bolnikov, v skupini, ki je prejemala placebo, pa pri skupno 5 od 31 (16%) na koncu študije ali pred njim opazili povečanje vrednosti FEV1 za najmanj 0,2 l, kar kaže na od odmerka odvisno izboljšanje obstrukcije dihalnih poti.
English: Fifty-four percent of patients tested positive for neutralizing antibodies at least once and half of the patients tested positive for neutralizing antibodies on at least three consecutive study visits.
Slovenian: Štiriinpetdeset odstotkov bolnikov je bilo vsaj enkrat pozitivnih na nevtralizirajoča protitelesa in pol bolnikov je bilo pozitivnih na nevtralizirajoča protitelesa ob vsaj treh zaporednih študijskih obiskih.
English: The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing (redness).
Slovenian: Najpogostejši simptomi so srbenje, izpuščaj, koprivnica, zvišana telesna temperatura, glavobol, zvišan krvni tlak in vročinski oblivi (rdečica).
English: Changes in urinary GAG levels were the earliest signs of clinical improvement with idursulfase treatment and the greatest decreases in urinary GAG were seen within the first 4 months of treatment in all treatment groups; changes from Month 4 to 36 were small.
Slovenian: Največje zmanjšanje vrednosti GAG v urinu so opazili v prvih štirih mesecih zdravljenja v vseh skupinah, ki so jih zdravili; spremembe od četrtega do 36. meseca so bile majhne.
English: Patients with this genotype have a higher probability of developing infusion-related adverse events and tend to show a muted response as assessed by decrease in urinary output of glycosaminoglycans, liver size and spleen volume compared to patients with the missense genotype.
Slovenian: Bolniki s tem genotipom imajo večjo verjetnost, da razvijejo z infundiranjem povezane neželene učinke in so nagnjeni k zmanjšani odzivnosti, kar so ocenili po zmanjšanem izločanju glikozaminoglikanov z urinom, velikosti jeter in volumnu vranice v primerjavi z bolniki z genotipom z »missense« (drugačnosmiselno) mutacijo.
English: Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue.
Slovenian: Glikozaminoglikan se značilno kopiči v vranici, jetrih, pljučih, srcu in vezivnem tkivu.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: You may be given additional medicines such as antihistamines and corticosteroids to treat or help prevent allergic-type reactions.
Slovenian: Za preprečevanje alergijskih reakcij boste morda prejeli dodatna zdravila, kot so antihistaminiki in kortikosteroidi.
English: Once diluted, the solution should be mixed gently, but not shaken.
Slovenian: Raztopino po redčenju nežno premešajte, vendar je ne stresajte.
English: Care must be taken to ensure the sterility of the prepared solutions since Elaprase does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Slovenian: Zdravilo Elaprase ne vsebuje nikakršnih konzervansov ali bakteriostatičnih sredstev, zato morate paziti, da je pripravljena raztopina sterilna; uporabiti morate aseptično tehniko.
English: Each vial contains 3 ml of concentrate for solution for infusion.
Slovenian: Ena viala vsebuje 3 ml koncentrata za raztopino za infundiranje.
English: It was not possible, however, to accurately predict individual clinical outcome based on antibody response or genotype.
Slovenian: Vendar pa na podlagi odziva s protitelesi ali genotipa ni bilo mogoče natančno napovedati kliničnih rezultatov za posamezne bolnike.
English: Study HGT-ELA-038
Slovenian: Študija HGT-ELA-038
English: Twenty-one percent (13/63) tested positive for neutralizing antibodies at least once and 13 % (8/63) tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Slovenian: Enaindvajset odstotkov bolnikov (13/63) je bilo vsaj enkrat pozitivnih za nevtralizirajoča protitelesa, 13 % (8/63) pa jih je bilo za nevtralizirajoča protitelesa pozitivnih pri vsaj 3 zaporednih obiskih v študiji.
English: ≥ 40 and < 50 (n=5)
Slovenian: ≥ 40 in < 50 (n=5)
English: Patients who tested antibody-positive displayed less reduction in urinary output of glycosaminoglycans than antibody-negative patients.
Slovenian: Pri bolnikih, ki so bili pozitivni za protitelesa, se je pojavilo manjše zmanjšanje izločanja glikozaminoglikanov z urinom kot pri bolnikih, negativnih za protitelesa.
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) CL (mL/min/kg) Mean ± SD Vss (mL/kg)
Slovenian: AUC0-∞ (min*μg/ml) CL (ml/min/kg) Srednja vrednost ± SD
English: Patients using supplemental oxygen should have this treatment readily available during infusion in the event of an infusion-related reaction.
Slovenian: Pri bolnikih, ki prejemajo nadomestni kisik, mora biti zaradi možnosti razvoja učinkov, povezanih z infundiranjem, tako zdravljenje na voljo ves čas infundiranja.
English: Patients experiencing severe or refractory anaphylactoid/anaphylactic reactions may require prolonged clinical monitoring.
Slovenian: Bolnike s hudimi ali refraktarnimi anafilaktoidnimi/anafilaktičnimi reakcijami bo morda treba opazovati dalj časa.
English: Table 4.
Slovenian: Tabela 4.
English: Talk to your doctor or nurse before using this medicine.
Slovenian: Pred začetkom uporabe tega zdravila se posvetujte z zdravnikom ali medicinsko sestro.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: - The solution in the vials should not be used if it is discoloured or if particulate matter is present.
Slovenian: - Ne uporabljajte, če je raztopina v vialah spremenila barvo ali če so v njej prisotni delci.
English: Mean treatment difference compared with placebo (SE)
Slovenian: Srednja vrednost razlike med zdravljenjem in placebom (SN)
English: How to use Elaprase
Slovenian: Kako uporabljati zdravilo Elaprase
English: ≥ 20 and < 30 (n=18)
Slovenian: ≥ 20 in < 30 (n=18)
English: Infusion-related reactions
Slovenian: Učinki, povezani z infundiranjem
English: Pharmacokinetic parameters measured during the first infusion at week 1 of studies TKT024 (0.5 mg/kg weekly arm) and HGT-ELA-038 are displayed in table 3 and table 4 below as a function of age and body weight, respectively.
Slovenian: Farmakokinetični parametri, izmerjeni med prvo infuzijo v 1. tednu študije TKT024 (krak z odmerkom 0,5 mg/kg tedensko) in študije HGT-ELA-038, v odvisnosti od starosti in telesne mase, so prikazani v tabelah 3 in 4.
English: Elaprase contains sodium
Slovenian: Zdravilo Elaprase vsebuje natrij
English: ≥ 30 and < 40 (n=9)
Slovenian: ≥ 30 in < 40 (n=9)
English: Treatment of Hunter syndrome patients with intravenous idursulfase provides exogenous enzyme for uptake into cellular lysosomes.
Slovenian: Pri zdravljenju bolnikov s Hunterjevim sindromom z idursulfazo lahko celični lizosomi privzamejo eksogeni encim.
English: Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well.
Slovenian: Pri bolnikih, ki so prejeli več mesecev zdravljenja na kliniki in dobro prenašajo infundiranje, je infundiranje mogoče tudi na domu.
English: Anaphylactoid/anaphylactic reactions
Slovenian: Anafilaktoidne/anafilaktične reakcije
English: • Dizziness, tremor
Slovenian: • zasoplost, sopenje
English: Cyanosis, arrhythmia, tachycardia
Slovenian: Srčne bolezni cianoza, aritmija, tahikardija
English: For single use only Read the package leaflet before use Intravenous use
Slovenian: Pred uporabo preberite priloženo navodilo!
English: The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Slovenian: Učinkovina je idursulfaza, ki ima obliko humanega encima iduronat-2-sulfataze.
English: All patients with the frameshift/splice site mutation genotype developed antibodies and 4/6 also tested positive for neutralizing antibodies on at least 3 consecutive study visits.
Slovenian: Tudi vsi bolniki z mutacijo »frameshift« (premik bralnega okvira) oz. »splice site« (mutacija, ki spremeni mesto cepitve) so razvili protitelesa in pri 4 od 6 teh bolnikov so bili testi za nevtralizirajoča protitelesa pozitivni ob vsaj treh zaporednih študijskih obiskih.
English: Based on its metabolism in cellular lysosomes, idursulfase would not be a candidate for cytochrome P450 mediated interactions.
Slovenian: Idursulfaza se presnavlja v celičnih lizosomih, zato ni pričakovati interakcij povezanih s citokrom P450.
English: abdominal pain, nausea, and chest pain.
Slovenian: glavobol, bruhanje, bolečine v trebuhu, navzea in bolečina v prsih.
English: During clinical trials, the most common infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria), pyrexia, headache, hypertension, and flushing.
Slovenian: Med kliničnimi preskušanji so bili najpogostejši učinki, povezani z infundiranjem, kožne reakcije (izpuščaj, pruritus, urtikarija), pireksija, glavobol, hipertenzija in vročinski obliv.
English: 5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.
Slovenian: 5-mililitrska viala (steklo vrste I) z zamaškom (butilna guma, obložena s fluorovo smolo), enodelno tesnilo in modra zaporka „flip-off“.
English: No patient discontinued treatment due to an infusion reaction during clinical studies.
Slovenian: Zaradi učinkov, povezanih z infundiranjem, med kliničnimi preskušanji niso prekinili zdravljenja pri nobenem bolniku.
English: Of the 9 patients in the weekly treatment group with abnormally large spleens at baseline, 3 had spleen volumes that normalized by the end of the study.
Slovenian: Med 9 bolniki z nenormalno povečano vranico na začetku študije v skupini, ki je zdravljenje prejemala tedensko, se je do konca študije velikost vranice povrnila na normalno prostornino pri treh bolnikih.
English: • Hives, rash, itching, redness of the skin
Slovenian: • koprivnica, izpuščaj, srbenje, rdečica kože
English: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Water for injections
Slovenian: polisorbat 20 natrijev klorid natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat voda za injekcije
English: Common side effects (may affect up to 1 in 10 people) are:
Slovenian: Pogosti neželeni učinki (pojavijo se pri največ 1 od 10 bolnikov) so:
English: After dilution this medicine is given through a vein (drip feed).
Slovenian: Zdravilo se po redčenju daje v veno (z infuzijo).
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity, toxicity to reproduction and development and to male fertility.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnih in ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja ter vpliva na plodnost samcev ne kažejo posebnega tveganja za človeka.
English: The most common of these infusion-related reactions included cutaneous reactions (rash, pruritus, urticaria, and erythema), pyrexia, flushing, wheezing, dyspnoea, headache, vomiting,
Slovenian: Najpogostejši učinki, povezani z infundiranjem, so bile kožne reakcije (izpuščaj, pruritus, urtikarija in eritem), pireksija, vročinski oblivi, sopenje, dispneja,
English: Pharmacokinetic parameters at week 1 as a function of age in Studies TKT024 and HGT-ELA-038
Slovenian: Farmakokinetični parametri v 1. tednu študij TKT024 in HGT-ELA-038 v odvisnosti od starosti
English: Adverse reactions that were reported for the 32 patients treated with 0.5 mg/kg idursulfase weekly in the TKT024 phase II/III 52-week placebo-controlled study were almost all mild to moderate in severity.
Slovenian: Skoraj vsi neželeni učinki, o katerih so poročali pri 32 bolnikih, ki so jih zdravili z 0,5 mg/kg idursulfaze na teden v 52-tedenski, s placebom nadzorovani študiji TKT024 II./III.
English: Anaphylactoid/anaphylactic reactions, which have the potential to be life threatening, have been observed in some patients treated with idursulfase up to several years after initiating treatment.
Slovenian: Pri nekaterih bolnikih, ki so prejemali idursulfazo, so tudi do nekaj let po začetku zdravljenja opažali anafilaktoidne/anafilaktične reakcije, ki so lahko smrtno nevarne.
English: Elaprase 2 mg/ml sterile concentrate idursulfase
Slovenian: Elaprase 2 mg/ml sterilni koncentrat idursulfaza i.v.
English: Elaprase 2 mg/ml concentrate for solution for infusion
Slovenian: Elaprase 2 mg/ml koncentrat za raztopino za infundiranje
English: What Elaprase contains
Slovenian: Kaj vsebuje zdravilo Elaprase
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) Bistra do rahlo opalescentna, brezbarvna raztopina.
English: Each vial of Elaprase contains 6 mg of idursulfase.
Slovenian: Vsaka viala zdravila Elaprase vsebuje 6 mg idursulfaze.
English: Idursulfase treatment resulted in up to 60% reduction in urine output of glycosaminoglycans and in reductions of liver and spleen size: results were comparable to those found in study TKT024.
Slovenian: Zdravljenje z idursulfazo je povzročilo do 60-odstotno zmanjšanje izločanja glikozaminoglikanov z urinom ter zmanjšanje velikosti jeter in vranice.
English: Idursulfase
Slovenian: Občasni
English: Elaprase 2 mg/ml concentrate for solution for infusion idursulfase
Slovenian: Elaprase 2 mg/ml koncentrat za raztopino za infundiranje idursulfaza
English: This medicinal product contains 0.482 mmol sodium (or 11.1 mg) per vial.
Slovenian: To zdravilo vsebuje 0,482 mmol natrija (ali 11,1 mg) na vialo, kar je enako 0,6 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g.
English: If you experience an allergic side effect following administration of this medicine, you should contact your doctor immediately.
Slovenian: Če po dajanju tega zdravila opazite tako reakcijo, takoj povejte zdravniku.
English: All patients received weekly idursulfase up to 3.2 years in an extension to this study (TKT024EXT).
Slovenian: V podaljšku te študije (TKT024EXT) so vsi bolniki idursulfazo prejemali do 3,2 leta enkrat na teden.
English: Anaphylactoid/ anaphylactic reaction
Slovenian: Bolezni imunskega sistema anafilaktoidne/anafilaktične reakcije
English: Specific Obligation 5 - To evaluate the following long term clinical endpoints primarily through the HOS.
Slovenian: Posebna obveznost 5 - Oceniti naslednje dolgotrajne klinične opazovane dogodke, predvsem z raziskavo HOS: ti podatki se bodo ponovno ocenili vsako leto, rezultati pa se bodo poročali in obravnavali z vsakoletnimi ponovnimi ocenami.
English: A total of 108 male Hunter syndrome patients with a broad spectrum of symptoms were enrolled in the two randomized, placebo-controlled clinical studies, 106 continued treatment in two open-label, extension studies.
Slovenian: V dveh randomiziranih, s placebom nadzorovanih kliničnih študijah je sodelovalo 108 moških bolnikov s Hunterjevim sindromom s širokim spektrom simptomov.
English: Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion .
Slovenian: Skupen volumen potrebnega koncentrata za raztopino za infundiranje Elaprase razredčite v 100 ml raztopine natrijevega klorida za infundiranje (9 mg/ml; 0,9 %).
English: Do not freeze
Slovenian: Ne zamrzujte.
English: Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders Wheezing, dyspnoea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora sopenje, dispneja hipoksija, bronhospazem, kašelj tahipneja
English: Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use.
Slovenian: Zdravilo Elaprase je namenjeno intravenskemu infundiranju in ga je treba pred uporabo razredčiti v 0,9-odstotni raztopini (9 mg/ml) natrijevega klorida za infundiranje.
English: Speak with your healthcare professional if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravstvenim delavcem.
English: Assessment of long term pulmonary morbidity (e.g., incidence of infections, pulmonary function status) and mortality Assessment of long term cardiovascular morbidity (e.g., incidence of events, and echocardiography data, where available) and mortality Assessment of long term urinary GAG excretion patterns Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters
Slovenian: Ocena dolgotrajne kardiovaskularne obolevnosti (npr. incidenca dogodkov in podatkov o ehografiji, kadar so na razpolago) in umrljivosti.
English: • Chest pain
Slovenian: • bolečine v prsnem košu
English: Patients with renal or hepatic impairment There is no clinical experience in patients with renal or hepatic insufficiency.
Slovenian: Bolniki z ledvično in jetrno okvaro Kliničnih izkušenj pri bolnikih z ledvično ali jetrno insuficienco ni (glejte poglavje 5.2).
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol vrtoglavica, tremor
English: • Swollen tongue, indigestion
Slovenian: • otečen jezik, prebavne motnje
English: Each ml contains 2 mg of idursulfase.
Slovenian: Vsak ml vsebuje 2 mg idursulfaze.
English: Infusion-site swelling, face oedema, oedema peripheral Injury, poisoning and procedural complications Infusion-related reaction
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih učinki, povezani z infundiranjem
English: • Infusion-site swelling, swelling of the extremities, facial swelling
Slovenian: • otekanje na mestu infundiranja, otekanje okončin, otekanje obraza
English: How to store Elaprase
Slovenian: Shranjevanje zdravila Elaprase
English: - The total volume required of Elaprase should be diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion.
Slovenian: - Razredčite skupen potreben volumen zdravila Elaprase v 100 ml 0,9-odstotne raztopine natrijevega klorida za infundiranje (9 mg/ml).
English: Each ml contains 2 mg of idursulfase*.
Slovenian: En mililiter vsebuje 2 mg idursulfaze*.
English: - The number of vials to be diluted should be determined based on the individual patient's weight and the recommended dose of 0.5 mg/kg.
Slovenian: - Glede na bolnikovo telesno maso in priporočeni odmerek 0,5 mg/ml določite število vial, ki jih morate razredčiti.
English: Weight (kg)
Slovenian: Vss (ml/kg)
English: Each vial contains 6 mg of idursulfase.
Slovenian: Ena viala vsebuje 6 mg idursulfaze.
English: Pharmacokinetic parameters at week 1 as a function of body weight in studies TKT024 and HGT-ELA-038
Slovenian: Farmakokinetični parametri v 1. tednu študij TKT024 in HGT-ELA-038 v odvisnosti od telesne mase Telesna masa (v kg)
English: Sodium chloride
Slovenian: Idursulfaza Placebo
English: Elaprase has to be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion before use.
Slovenian: Zdravilo Elaprase je treba pred uporabo razredčiti v 0,9-odstotni raztopini natrijevega klorida za infundiranje (9 mg/ml).
English: LIST OF EXCIPIENTS
Slovenian: Vodenje evidence
English: What you need to know before you use Elaprase 3.
Slovenian: Kaj je zdravilo Elaprase in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Elaprase Kako uporabljati zdravilo Elaprase Možni neželeni učinki
English: Cmax (μg/mL) Mean ± SD AUC0-∞ (min*μg/mL) Mean ± SD CL (mL/min/kg) Mean ± SD Vss (mL/kg) Mean ± SD
Slovenian: AUC0-∞ (min*μg/ml) Srednja vrednost ± SD
English: After dilution
Slovenian: Po razredčitvi
English: Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4).
Slovenian: Zdravilo Elaprase se daje v odmerku 0,5 mg/kg telesne mase vsak teden kot triurna intravenska infuzija.
English: Gastrointestinal disorders Abdominal pain, nausea, diarrhoea, vomiting
Slovenian: Bolezni prebavil bolečine v trebuhu, navzea, driska, bruhanje otečen jezik, dispepsija
English: The solution should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Raztopino pred uporabo vizualno preglejte in preverite, ali so v njej delci in ali je spremenila barvo.
English: Skin and subcutaneous tissue disorders Urticaria, rash, pruritus, erythema Musculoskeletal and connective disorders Arthralgia General disorders and administration site conditions Pyrexia, chest pain
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, bolečine v prsnem košu otekanje na mestu infundiranja,
English: Swollen tongue, dyspepsia
Slovenian: edem obraza, periferni edem
English: - Keep this leaflet.
Slovenian: Raztopine ne pretresajte.
English: BACKGROUND INFORMATION
Slovenian: DODATNE INFORMACIJE
English: European Medicines Agency Evaluation of Medicines for Human Use
Slovenian: Država članica Imetnik dovoljenja za promet z zdravilom
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Slovenian: Nesoglasja, ki so privedla do tega napotitvenega postopka v skladu s členom 29(4) Direktive 2001/83/ES, zadevajo: 1- terapevtsko indikacijo, ki bi naj bila razširjena na nerakave bolnike s hudo kronično bolečino 2- izbor tabel za prehod z drugih analgetikov, ki bi naj bile vključene v povzetek glavnih značilnosti zdravila 3- vprašanje, ali naj bosta dojenje in sočasna uporaba z delnimi opioidnimi agonisti kontraindicirana 4- bioekvivalenčne študije, potrebne za dokazovanje ekvivalentnosti z referenčnim izdelkom.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
English: The arbitration procedure started on 24 January 2007 with the adoption of a list of questions.
Slovenian: Učinek se doseže v roku 24 ur po namestitvi prvega obliža, po odstranitvi pa postopoma izzveni.