natgillin/translations-raw huggingface dataset:
In vivo studies conducted with a hydromorphone formulation based on ammonio methacrylate copolymer type B (Eudragit RS) confirmed the existing in vitro data suggesting that alcohol affects the formulation.
In vivo študije, izvedene s formulacijo hidromorfona na osnovi amonijevega metakrilata ko-polimera tipa B (Eudragit RS), so potrdile obstoječe in vitro podatke, ki kažejo, da alkohol učinkuje na formulacijo.
The CHMP had not addressed the issue of the additional risk to patients posed by modified release formulations of opioids which exhibit a greater vulnerability to alcohol compared with the reference product, whilst conferring no additional patient benefit.
Odbor ni obravnaval vprašanja dodatnega tveganja za bolnike, ki ga predstavljajo formulacije opioidov s prirejenim sproščanjem, ki kažejo večjo občutljivost na alkohol v primerjavi z referenčnim zdravilom, pri tem pa ne zagotavljajo nobenih dodatnih koristi za bolnika.
• The Committee took the view that modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism are harmful under the normal conditions of use in accordance with article 116 of Directive 2001/83/EC, as amended.
• Odbor je podprl stališče, da so peroralna opioidna zdravila s prirejenim sproščanjem III. stopnje po lestvici SZO za lajšanje bolečin, ki vsebujejo premaz iz polimetakrilat-trietilcitrata kot mehanizem za prirejeno sproščanje, pri normalnih pogojih uporabe v skladu s členom 116 Direktive 2001/83/ES, kakor je bila spremenjena, škodljiva.
• The Committee, based on the published literature, considered that a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications, and that therefore the existing risk minimisation measures do not adequately address the concern,
• Odbor je na podlagi objavljene literature ugotovil, da se pomemben delež bolnikov, ki se zdravi s temi zdravili, navkljub obstoječim opozorilom in kontraindikacijam ne vzdržuje pri uporabi alkohola, zato obstoječi ukrepi za zmanjševanje tveganja tega vprašanja ne obravnavajo ustrezno.
The question of what could be considered as a clinical significant interaction with alcohol was left for the EWP to consider.
Odgovor na vprašanje, kaj velja za klinično pomembno interakcijo z alkoholom, je morala podati delovna skupina za učinkovitost.
The Committee also reflected on the usefulness for prescribers and patients of a pharmacokinetic warning in the Product Information referring to the in vitro data.
Odbor je ocenil tudi uporabnost farmakokinetičnega opozorila glede in vitro podatkov v informacijah o zdravilu za predpisovalce in bolnike.
In its detailed grounds for re-examination the MAH referred to statistical analysis confirming different behaviours in the presence of alcohol for a generic and its originator product.
V podrobni utemeljitvi zahtevka za ponovni pregled je imetnik dovoljenja za promet z zdravilom navedel statistično analizo, ki je potrdila različno delovanje generičnega in originatorskega zdravila v prisotnosti alkohola.
• The Committee considered that, based on the published literature, a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications,
• Odbor je na podlagi objavljene literature ugotovil, da pomemben delež bolnikov, ki se zdravi s temi zdravili, navkljub obstoječim opozorilom in kontraindikacijam ne preneha z uživanjem alkohola.
Not all MAHs of modified-release oral opioid products in the level III of the WHO scale for the management of pain in the European market submitted data, and so it can not be guaranteed that all products approved in the EU have been assessed.
Ker podatkov niso predložili vsi imetniki dovoljenja za promet s peroralnimi opioidnimi zdravili s prirejenim sproščanjem III. stopnje po lestvici SZO za lajšanje bolečin na evropskem trgu, ni mogoče potrditi, da so bila ocenjena vsa v EU odobrena zdravila.
The CHMP having assessed all the detailed grounds for re-examination and argumentation presented by the MAH and having considered the views of the Rapporteurs, the scientific discussion within the Committee and the conclusions of the ad hoc expert group as well as the concerns raised by the MAH in this respect, concluded that products with a polymethacrylate-triethylcitrate coating are harmful under the normal conditions of use and that, for the remaining products, the Product Information should be amended to include a warning and recommendation for avoiding concomitant use with alcohol.
CHMP je proučil podrobno utemeljitev zahtevka za ponovni pregled in dokaze, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, ter ob upoštevanju stališč poročevalcev, znanstvene razprave v odboru in sklepov ad hoc strokovne skupine ter zadržkov, ki jih je v zvezi s tem izrazil imetnik dovoljenja za promet z zdravilom, zaključil, da so zdravila s prevleko iz polimetakrilatatrietilcitrata v normalnih pogojih uporabe škodljiva in da je treba pri ostalih zdravilih spremeniti podatke o zdravilu tako, da bodo vključevali opozorilo in priporočilo glede izogibanja sočasni uporabi z alkoholom.
Considering that the proposed pharmacodynamic warning already advises against concomitant use with alcohol, considering also the limitations of the in vitro data and difficulties in its interpretation by prescribers, the majority of the Committee was of the opinion that the addition of a pharmacokinetic interaction warning based on a description of the in vitro data would not favour the clarity of the message to patients and prescribers regarding the need to avoid concomitant use with alcohol.
Ob upoštevanju, da je v predlaganem farmakodinamičnem opozorilu sočasna uporaba z alkoholom že odsvetovana, ob upoštevanju omejenih in vitro podatkov in težav, ki jih imajo pri njihovi interpretaciji predpisovalci, je večina članov Odbora menila, da vključitev opozorila glede farmakokinetične interakcije na podlagi opisa in vitro podatkov ne bi prispevala k jasnosti sporočila bolnikom in predpisovalcev glede izogibanja sočasni uporabi z alkoholom.
Overall summary of the scientific evaluation of modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) (see Annex I)
Splošni povzetek znanstvenega vrednotenja peroralnih opioidnih zdravil s prirejenim sproščanjem III stopnje po lestvici Svetovne zdravstvene organizacije za lajšanje bolečin (močne dolgotrajne bolečine, odporne na predhodna zdravila) (glejte Prilogo I)
Food related interactions are taken into consideration and reflected in the SPC and package leaflet for the benefit of patients and prescribers.
Interakcije, povezane s hrano, se zato upoštevajo in so v korist bolnikov in predpisovalcev navedene v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
Consequently, the CHMP has recommended the suspension of the marketing authorisation for modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism (see annex I).
CHMP je tako priporočil začasni umik dovoljenja za promet za peroralna opioidna zdravila s prirejenim sproščanjem III. stopnje po lestvici SZO za lajšanje bolečin, ki vsebujejo premaz iz polimetakrilattrietilcitrata kot mehanizem za prirejeno sproščanje (glejte Prilogo I).
The dissolution profile of this product (80% dissolved substance within 15 min in 20% alcohol) is beyond the limit of the Ph. Eur.
Profil raztapljanja tega zdravila (80 odstotkov raztopljene snovi v 15 minutah v 20 odstotkih alkohola) presega mejne vrednosti Evropske farmakopeje za zdravila s konvencionalnim sproščanjem (ne manj kot 75 odstotkov raztopljene zdravilne učinkovine v 45 minutah).
Further to that, the IVIV correlation is, at present time, uncertain for most products.
Poleg tega je za večino zdravil korelacija in vitro - in vivo trenutno negotova.
Whereas
Brez
It is however clear that, in the cases where the highest degree of in vitro interaction was observed, the high alcohol solubility of the excipients provided a clear explanation for the observation.
V primerih, ko je bila opažena najvišja stopnja in vitro interakcije, je bilo to mogoče razložiti z visoko topnostjo pomožnih snovi v alkoholu.
This is justified on the basis that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation.
To utemeljuje dejstvo, da se lahko farmakodinamična interakcija med opioidnim zdravilom in alkoholom pojavi neodvisno od formulacije.
The exception is one morphine formulation using polymethacrylate-triethylcitrate coating as modified-release mechanism, for which dose dumping might occur when taken together with alcohol.
Izjema je bila le ena formulacija morfina, pri kateri je uporabljen premaz iz polimetakrilattrietilcitrata kot mehanizem za prirejeno sproščanje in pri kateri se lahko pri sočasni uporabi z alkoholom pojavi učinek prekomernega sproščanja.
It is clearly stated in the Opinion that 50% of the formulations were found to be affected by alcohol in vitro.
V mnenju je jasno navedeno, da je alkohol in vitro učinkoval na 50 odstotkov formulacij.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications),
• Odbor je upošteval postopek v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za peroralna opioidna zdravila s prirejenim sproščanjem III. stopnje po lestvici SZO za lajšanje bolečin (močne dolgotrajne bolečine, odporne na predhodna zdravljenja),
In its detailed grounds for re-examination, the MAH referred to a competitor product in which the release of oxycodone is accelerated in the presence of alcohol as an example of a potentially clinically meaningful interaction.
Imetnik dovoljenja za promet z zdravilom je v podrobni utemeljitvi zahtevka za ponovni pregled kot primer možne klinično pomembne interakcije navedel konkurenčno zdravilo, pri katerem je sproščanje oksikodona v prisotnosti alkohola pospešeno.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) on the EU market,
• Odbor je upošteval postopek v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za peroralna opioidna zdravila s prirejenim sproščanjem III. stopnje po lestvici SZO za lajšanje bolečin (močne dolgotrajea bolečine, odporne na predhodna zdravljenja), ki so na trgu EU.
The MAH further considered, in its grounds for re-examination, that the CHMP opinion was inconsistent in its approach regarding alcohol versus food interactions.
V utemeljitvi zahtevka za ponovni pregled je imetnik dovoljenja za promet z zdravilom menil, da je bilo mnenje Odbora glede pristopa do interakcije z alkoholom neskladno s pristopom do interakcije s hrano.
From the products tested, fifty percent of the formulations were found to be affected by alcohol solutions in vitro.
Med in vitro preizkušanimi zdravili je bilo 50 odstotkov formulacij, na katere so vplivale alkoholne raztopine.
The Opinion did not take account of the earlier advice of its own working parties, namely the EWP and QWP, which had been requested by the CMD(h); nor did it provide any proper reasons for discounting that advice.
Pri izdanem mnenju niso bili upoštevani predhodni nasveti delovnih skupin Odbora, in sicer delovne skupine za učinkovitost in delovne skupine za kakovost, ki jih je naročila Usklajevalna skupina za postopke z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini, prav tako pa niso bili navedeni ustrezni razlogi za neupoštevanje teh mnenj.
This morphine formulation with polymethacrylate- triethylcitrate coating as modified-release mechanism has been identified as a product where dose dumping might occur when taken together with alcohol.
Ugotovljeno je bilo, da je ta morfinska formulacija s premazom iz polimetakrilat-trietilcitrata kot mehanizmom za prirejeno sproščanje zdravilo, pri katerem se lahko ob sočasnem uživanju alkohola pojavi učinek prekomernega sproščanja.
• The Committee noted that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
• Odbor je ugotovil, da se farmakodinamična interakcija med opioidnimi zdravili in alkoholom lahko pojavi neodvisno od formulacije.
Further to the request from the MAH, the CHMP convened an Ad-Hoc Expert meeting including experts on technology/formulation science, pharmacokinetics and clinical/medical practice in order to deliver answers on a consultative basis to specific questions in relation to the grounds for re-examination.
farmakokinetike in klinične/medicinske prakse, da bi s posvetovanjem prišli do odgovorov na specifična vprašanja v zvezi z utemeljitvijo zahtevka za ponovni pregled.
A product containing hydromorphone and a prolonged release system consisting of ammonio methacrylate co-polymer type B (Eudragit RS) also suffered a significant effect of high concentrations of alcohol on in vitro dissolution.
Pomemben učinek pri visoki koncentraciji alkohola na in vitro raztopino se je pokazal tudi pri zdravilu, ki vsebuje hidromorfon, njegov sistem podaljšanega sproščanja pa je sestavljen iz kopolimera amonijevega metakrilata tipa B (Eudragit RS).
In order to assess the potential for dose-dumping of each product, MAHs of products in the level III of the WHO scale for the management of severe pain were asked to submit data on their products.
Imetniki dovoljenja za promet z zdravili III stopnje po lestvici SZO za lajšanje hudih bolečin so bili zaprošeni, da predložijo podatke o svojih zdravilih za ocenitev možnosti prekomernega sproščanja vsakega posameznega zdravila.
• The Committee considered that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Odbor je menil, da se lahko farmakodinamična interakcija med opioidnimi zdravili in alkoholom pojavi neodvisno od formulacije.
The withdrawal letter is available here.
Dopis o umiku vloge je na voljo tukaj.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you.
Če ste vključeni v klinično preskušanje in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
It was to be available as a suspension for inhalation.
Na voljo naj bi bilo v obliki suspenzije za inhaliranje.
What consequences does this withdrawal have for patients in clinical trials?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih?
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na zadnji sklop vprašanj, so nekatera vprašanja še vedno ostala nerešena.
It was to be used in patients whose infection has persisted despite previous treatment.
Uporabljalo naj bi se pri bolnikih, pri katerih je okužba tudi po predhodnem zdravljenju še vedno prisotna.
Further information on the orphan designation can be found here.
Več informacij o zdravilih sirotah je na voljo tukaj.
Withdrawal of the marketing authorisation application for Arikayce (amikacin) EMA/430267/2016
Umik vloge za pridobitev dovoljenja za promet z zdravilom Arikayce (amikacin) EMA/430267/2016
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
Withdrawal of the marketing authorisation application for Arikayce (amikacin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Arikayce (amikacin)
Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection.
Ker se zdravilo vdihava, tudi pljuča doseže prej kot amikacin, ki se daje z injiciranjem.
In this medicine, amikacin is contained within microscopic fat capsules known as liposomes.
V tem zdravilu amikacin obdaja mikroskopska maščobna kapsula, imenovana liposom.
The Committee's main concern was that the study submitted in the application did not provide enough evidence that Arikayce can permanently clear the bacteria from patients' sputum.
Glavni pomislek odbora je bil, da študija, ki so jo predložili z vlogo, ne zagotavlja dovolj dokazov, da lahko zdravilo Arikayce trajno odstrani bakterije iz bolnikovega izmečka.
What is Arikayce?
Kaj je zdravilo Arikayce?
In its letter notifying the Agency of the withdrawal, the company stated that its decision is based on the understanding that CHMP was not going to recommend approval of the medicine on the basis of current data.
V dopisu, s katerim družba Agencijo obvešča o umiku vloge, je navedeno, da odločitev družbe temelji na njenem razumevanju, da CHMP na podlagi trenutnih podatkov ne bo priporočil odobritve zdravila.
On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.
Družba Insmed Limited je dne 8. junija 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Arikayce, namenjenim zdravljenju pljučne bolezni, ki jo povzroča kompleks mikobakterij Mycobacterium avium.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials for Arikayce.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Arikayce.
The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria.
Družba je predložila rezultate zgodnje študije (2. faze) pri 89 odraslih bolnikih s pljučnimi okužbami, ki jih povzročajo kompleks mikobakterij Mycobacterium avium ali podobne bakterije.
These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer.
Ti liposomi pripomorejo k upočasnitvi razgrajevanja zdravilne učinkovine in podaljšajo čas njenega zadrževanja v telesu.
This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment.
V tej študiji so primerjali zdravilo Arikayce s placebom (zdravilom brez zdravilne učinkovine) in ugotavljali, kako učinkovito je zdravilo odstranilo bakterije iz bolnikovega izmečka (sluzi) po treh mesecih zdravljenja.
What was Arikayce expected to be used for?
Za kaj naj bi se zdravilo Arikayce uporabljalo?
Arikayce was expected to be used to treat adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water.
Zdravilo Arikayce naj bi se uporabljajo za zdravljenje odraslih s pljučno okužbo, ki jo povzroča kompleks mikobakterij Mycobacterium avium, skupina bakterij, ki so pogosto prisotne v okolju, na primer v prsti in vodi.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Arikayce did not outweigh its risks.
Zato je CHMP v času umika menil, da koristi zdravila Arikayce ne odtehtajo z njim povezanih tveganj.
The active substance in Arikayce, amikacin, is a well-established antibiotic of the group ‘aminoglycosides' that works by disrupting bacterial production of vital proteins.
Zdravilna učinkovina v zdravilu Arikayce, amikacin, je dobro uveljavljen antibiotik iz skupine „aminoglikozidov“, ki deluje tako, da pri bakterijah prekine tvorbo življenjsko pomembnih beljakovin.
Arikayce is an antibiotic containing the active substance amikacin.
Zdravilo Arikayce je antibiotik, ki vsebuje zdravilno učinkovino amikacin.
How is Arikayce expected to work?
Kako naj bi zdravilo Arikayce delovalo?
Based on the review of the data and the company's response to the CHMP lists of questions, the CHMP was of the provisional opinion that Arikayce could not be approved for the treatment of MAC lung infection.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor začasno menil, da zdravila Arikayce ni mogoče odobriti za zdravljenje pljučne okužbe s kompleksom mikobakterij Mycobacterium avium.
Arikayce was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 8 April 2014 for treating infections caused by MAC and similar bacteria.
Zdravilo Arikayce je bilo dne 8. aprila 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje okužb, ki jih povzročajo kompleks mikobakterij Mycobacterium avium in podobne bakterije.
Ethnic factors.
Etnični dejavniki.
Immediate admission to hospital is recommended.
Priporoča se takojšen sprejem v bolnišnico.
The clinical relevance of these differences is unknown.
Klinični pomen teh razlik ni poznan.
Median Time to Event (Days)
Mediana časa do dogodka (dnevi)
Interaction studies have only been performed in adults.
Študije medsebojnega delovanja so izvedli le pri odraslih.
This 21 day period is one treatment cycle.
To 21-dnevno obdobje je en cikel zdravljenja.
• Risk management plan (RMP)
• Načrt za obvladovanje tveganj (RMP)
This advice is applicable to all indications and to all special populations.
Ta nasvet velja za vse indikacije in za vse posebne skupine bolnikov.
- Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual.
- Slabost: če izgubite tek in je količina hrane, ki jo dnevno zaužijete, mnogo manjša kot ponavadi.
It cannot be excluded that other rare variants may also be associated with an increased risk of severe toxicity.
Ni mogoče izključiti, da so lahko tudi druge redke različice povezane s povečanim tveganjem za hudo toksičnost.
Tell your doctor immediately if you experience any of these symptoms.
Nemudoma povejte zdravniku, če opazite katerega koli od teh simptomov.
All measures should be initiated to prevent systemic infections and dehydration.
Uvesti je treba vse ukrepe za preprečevanje sistemskih okužb in dehidracije.
Median survival was 384 and 373 days.
Mediana preživetja je bila 384 in 373 dni.
This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
To je zelo pomembno, ker lahko jemanje več zdravil hkrati poveča ali oslabi njihov učinek.
See table 6 for treatment regimens.
Glejte preglednico 6 za sheme zdravljenja.
Your doctor will tell you what dose you need to take, when to take it and for how long you need to take it.
Zdravnik vam bo povedal, kolikšen odmerek morate jemati, kdaj ga vzeti in kako dolgo bo zdravljenje trajalo.
- Vomiting: if you vomit more than once in a 24-hour time period.
- Bruhanje: če bruhate več kot enkrat v 24 urah.
- Take the tablets morning and evening as prescribed by your doctor.
- Tablete jemljite zjutraj in zvečer, kot vam jih je predpisal zdravnik.
- It is important that you take all your medicine as prescribed by your doctor.
- Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal zdravnik.
Date of latest renewal: 9 December 2016
Datum prve odobritve: 20. april 2012 Datum zadnjega podaljšanja: 9. december 2016
- Fever: if you have a temperature of 38°C or greater.
- Zvišana telesna temperatura: če imate telesno temperaturo 38 °C ali več.
This increase is likely due to a change in renal function.
Razlog za povečanje je verjetno sprememba ledvičnega delovanja.
OTHER SPECIAL WARNING (S), IF NECESSARY
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA