natgillin/translations-raw huggingface dataset:
It was therefore concluded by the CHMP that efficacy and safety of dexamethasone active substance in the therapeutic indications applied for had been sufficiently demonstrated by the provided literature.
CHMP je zato zaključil, da sta učinkovitost in varnost zdravilne učinkovine deksametazon pri terapevtskih indikacijah, za katere je bila predložena vloga, zadostno dokazani s predloženo literaturo.
In order to extrapolate efficacy and safety data from these studies to the oral solution formulation applied for, the Applicant provided data that showed that irrespective of immediate release oral dosage formulation (tablet or solution), the bioavailability of dexamethasone in terms of extent and rate of absorption, was similar.
Da bi bilo mogoče podatke o učinkovitosti in varnosti iz teh študij prenesti na formulacijo v obliki peroralne raztopine, za katero je bila predložena vloga, je predlagatelj predložil podatke, iz katerih je razvidno, da je pri formulacijah s peroralno obliko odmerjanja s takojšnjim sproščanjem (tableta ali raztopina) biološka razpoložljivost deksametazona glede obsega in hitrosti absorpcije podobna.
As a justification for not providing bioequivalence study to bridge the data submitted on the tablet formulation and the oral solution formulation applied for, the Applicant applied for a BCS (Biopharmaceutics Classification System)-based biowaiver.
Kot utemeljitev, zakaj ni bila predložena študija biološke enakovrednosti za premostitev predloženih podatkov o formulaciji v obliki tablet in formulaciji v obliki peroralne raztopine, za katero je bila predložena vloga, je predlagatelj zaprosil za bio-opustitev na podlagi biofarmacevtskega sistema klasifikacije.
In addition, a few literature reports (CTs) on the efficacy and safety of dexamethasone in oral solution/syrup have been submitted in the following indications applied for:
Poleg tega je bilo za naslednje indikacije, za katere je bila predložena vloga, predloženih nekaj poročil iz literature (CT) o učinkovitosti in varnosti deksametazona v obliki peroralne raztopine/sirupa:
Therefore, a huge volume of efficacy and safety data exists for the dexamethasone pharmaceutical substance.
Za farmacevtsko učinkovino deksametazon torej obstaja veliko podatkov o učinkovitosti in varnosti.
Additional bridging data (or its absence fully justified) between the bibliographic data and the proposed pharmaceutical product were therefore requested to the Applicant during the decentralised and the CMD(h) referral procedures.
Med decentraliziranim postopkom in napotitvenim postopkom na CMD(h) so se zato od predlagatelja zahtevali dodatni premostitveni podatki (ali podrobna utemeljitev njihove odsotnosti) med bibliografskimi podatki in predlaganim zdravilom.
Whereas, - the Applicant has provided sufficient literature data to demonstrate well-established use of dexamethasone, - efficacy and safety of dexamethasone has been adequately shown in the indications applied for - adequate bridging data between the tablet formulation and the oral solution formulation have been provided by the Applicant, the CHMP has recommended the granting of the marketing authorisation(s) for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
CHMP je priporočil odobritev dovoljenj za promet z zdravilom, katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku usklajevalne skupine in navedenim v Prilogi III tega mnenja.
The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Nacionalni pristojni organi držav članic, ki jih usklajuje referenčna država članica, bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
Conditions for lifting the suspension of the Marketing Authorisations
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
Annex III Conditions for lifting the suspension of the Marketing Authorisations
Priloga III Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
This difference was considered to be too small to be relevant.
Ta razlika je bila premajhna, da bi bila pomembna.
International non-proprietary name (INN): ramelteon
Mednarodno nelastniško ime (INN): ramelteon
All of the studies but one were short-term, lasting five weeks or less.
Vse študije, razen ene, so bile kratke, saj so trajale pet tednov ali manj.
Ref. EMEA/CHMP/502946/2008
EMEA/549016/2008
‘Primary' means that the insomnia does not have any identified cause, including other medical, mental or environmental causes.
„Primarna“ pomeni, da za nespečnost ni znanih vzrokov, na primer drugih zdravstvenih, duševnih ali okoljskih vzrokov.
Most of the studies were carried out in sleep laboratories, but the three main studies were carried out in the ‘natural setting' (at home) in a total of 2,807 patients.
Večina študij je potekala v spalnih laboratorijih, tri glavne študije pa so potekale v naravnem okolju (doma) s skupaj 2 807 bolniki.
It was to be available as tablets.
Naj voljo naj bi bilo v tabletah.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Družba je zahtevala ponovno proučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je odločila za umik svoje vloge.
The one long-term study lasted six months, during which patients spent some nights in a sleep laboratory.
Dolga študija je trajala šest mesecev, med njo pa so bolniki preživeli nekaj noči v spalnem laboratoriju.
The effects of Ramelteon were first tested in experimental models before being studied in humans.
Učinki zdravila Ramelteon so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main measure of effectiveness was the time taken for the patients to fall asleep.
Glavno merilo učinkovitosti je bil čas, potreben, da je bolnik zaspal.
Ramelteon was expected to be used to treat primary insomnia (difficulty falling and staying asleep, and poor quality of sleep) in patients aged 18 years or over.
Zdravilo Ramelteon naj bi se uporabljalo za zdravljenje primarne nespečnosti (težave z uspavanjem in zbujanje ter slaba kakovost spanca) pri bolnikih starih 18 let in več.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramelteon?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ramelteon?
On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.
Družba Takeda Global Research & Development Centre (Europe) Ltd je dne 19. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ramelteon, namenjenim zdravljenju primarne nespečnosti pri odraslih bolnikih.
The Committee was also concerned that the company had not demonstrated the long-term effectiveness of Ramelteon.
Odbor je imel pomisleke tudi zato, ker družba ni dokazala dolgotrajne učinkovitosti zdravila Ramelteon.
The effectiveness of Ramelteon was compared with that of placebo (a dummy treatment) in a total of about 5,400 patients.
Učinkovitost zdravila Ramelteon so primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine) pri skupaj približno 5 400 bolnikih.
Questions and answers on the withdrawal of the marketing application for Ramelteon
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ramelteon
Ramelteon was expected to work in the same way as melatonin in promoting sleep.
Zdravilo Ramelteon naj bi na enak način kot melatonin delovalo pri spodbujanju spanca.
only one of the three studies carried out in the natural setting was there a difference in the time taken to fall asleep between patients taking Ramelteon and those taking placebo.
Poleg tega je bila med študijami, ki so potekale doma, samo pri eni opažena razlika v času, potrebnem, da je bolnik zaspal, tj. med bolniki, ki so jemali Ramelteon in tistimi, ki so jemali placebo.
When other aspects of sleep were considered, Ramelteon did not have any effect.
Pri proučevanju drugih vidikov spanja zdravilo ni imelo Ramelteon nobenega učinka.
The CHMP was concerned that the company had not demonstrated the effectiveness of Ramelteon, which was measured by looking at only one aspect of insomnia, the time to fall asleep.
CHMP je imel pomisleke, da družba ni zadovoljivo dokazala učinkovitosti zdravila Ramelteon, ki je bila merjena z opazovanjem enega samega vidika nespečnosti, tj. časa, potrebnega, da je bolnik zaspal.
The active substance in Ramelteon, ramelteon, is a melatonin-receptor agonist.
Zdravilna učinkovina v zdravilu Ramelteon, ramelteon, je agonist receptorja melatonina.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Ramelteon for the treatment of primary insomnia in adult patients.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet za zdravilo Ramelteon, namenjenim zdravljenju primarne nespečnosti pri odraslih bolnikih.
This means that it works by attaching itself to the receptors that melatonin normally attaches to. Melatonin is a naturally occurring hormone that is involved in co-ordinating the body's sleep cycle by acting on receptors in specific areas of the brain.
Melatonin je naravno prisoten hormon, ki sodeluje pri usklajevanju spalnega cikla telesa tako, da učinkuje na receptorje v določenih predelih možganov.
Ramelteon is a medicine that contains the active substance ramelteon.
Ramelteon je zdravilo, ki vsebuje zdravilno učinkovino ramelteon.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programs with Ramelteon in the European Union.
Družba je CHMP obvestila, da v Evropski uniji ne potekajo nobena klinična preskušanja ali programi sočasne uporabe zdravila Ramelteon.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ramelteon had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
V času umika je zato CHMP menil, da koristi zdravila Ramelteon niso zadostno dokazane in da ne odtehtajo znanih tveganj.
What is Ramelteon?
Kaj je zdravilo Ramelteon?
What was Ramelteon expected to be used for?
Za kaj naj bi se zdravilo Ramelteon uporabljalo?
How is Ramelteon expected to work?
Kako naj bi zdravilo Ramelteon delovalo?
This procedure usually takes 3-4 hours.
Ta postopek običajno traja 3-4 ure.
In the insulated container 18 hours.
V izoliranem vsebniku 18 ur.
This may be due to a number of reasons, for example, if there is:
Vzrokov je lahko več, na primer:
Some have resulted in hospitalization.
Nekatere so povzročile hospitalizacijo.
It should not be given to children or adolescents under the age of 18 years.
Ni ga dovoljeno dajati otrokom ali mladostnikom, starim manj kot 18 let.
If this happens, do not drive or use any tools or machines until you feel better.
Če se to zgodi, ne vozite in ne upravljajte orodij ali strojev, dokler se ne počutite bolje.
• Additional risk minimisation measures
• Dodatni ukrepi za zmanjšanje tveganja
Educational material for Healthcare professionals 3.
Izobraževalno gradivo za zdravstvene strokovnjake 3.
A small number of these patients discontinued treatment as a result.
Majhno število teh bolnikov je posledično zdravljenje prekinilo.
To provide data from the observational US-based registry (PROCEED, Study P10-3)
Da predloži podatke iz seznama opazovanj v ZDA (PROCEED, študija P10-3)
It is very important that you arrive on time for your appointments.
Zelo pomembno je, da pravočasno pridete na vsak dogovorjen obisk.
Microbiological testing
Mikrobiološko testiranje
Abbreviations: CI = confidence interval.
Okrajšave: IZ = interval zaupanja
c p-value based on a log-rank test.
c vrednost p na podlagi testa log-rank.
Patients should be advised of this possibility prior to initiating treatment.
Bolnike je treba na to možnost pred začetkom zdravljenja opozoriti.
Overall survival was not a study endpoint but a pre-specified analysis.
Celokupno preživetje ni bil opazovani dogodek v študiji, temveč predhodno specificirana analiza.
These patients should be closely monitored for signs and symptoms of infection.
Te bolnike je treba skrbno spremljati za znake in simptome okužbe.
Once the infusion is complete you will be observed and monitored for at least 30-60 minutes, after which, you may go home.
Po končanem infundiranju vas bodo vsaj 30-60 minut opazovali in spremljali, nato pa lahko greste domov.
Submission of study protocol with first PSUR
Protokol študije predložiti s prvim PSUR
You may also be given other medicines if needed.
Po potrebi boste prejeli druga zdravila.
* Primarily associated with the leukapheresis procedure
* Primarno povezana s postopkom levkafereze
Table 2 Summary of overall survival (all patients as randomized) IMPACT
Preglednica 2 Povzetek celokupnega preživetja (vsi bolniki kot randomizirani) IMPACT
Your doctor or nurse will confirm that your details (name and date of birth) correspond to the details provided with the Provenge container.
Vaš zdravnik ali medicinska sestra bosta potrdila, da se vaši podatki (ime in datum rojstva) ujemajo s podrobnostmi na vsebniku z zdravilom Provenge.
A cell filter should not be used.
Celičnega filtra se ne sme uporabiti.
The physician should monitor and/or treat the patient as appropriate.
Zdravnik mora bolnika spremljati in/ali zdraviti, kot je ustrezno.
This peripheral delivery system is commonly used in clinical practice for the transfusion of blood components.
Ta periferni dostavni sistem se pogosto uporablja v klinični praksi za transfuzijo krvnih komponent.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/867/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/13/867/001
Your treatment will involve at least 6 visits to the cell collection site and/or clinic.
Vaše zdravljenje bo obsegalo vsaj 6 obiskov na mestu za odvzem celic in/ali v kliniki.
The median age was 71, 90% of the patients were Caucasian, and all had a life expectancy of at least 6 months.
Mediana starost je bila 71, 90 % bolnikov je bilo belcev, vsi pa so imeli pričakovano življenjsko dobo vsaj 6 mesecev.
The medicinal product should be used immediately.
Zdravilo je treba porabiti takoj.
The clinical significance is uncertain.
Klinični pomen ni znan.
The most severe side effects are described below:
Najpogostejši resni neželeni učinki so opisani spodaj:
This includes medicines obtained without a prescription and herbal medicines.
To vključuje tudi zdravila, ki ste jih kupili brez recepta in rastlinska zdravila.
In 95.1% of patients reporting acute infusion reactions, the events were mild or moderate.
Pri 95,1 % bolnikov, ki so poročali akutne reakcije na infundiranje, so bili dogodki blagi ali zmerni.
All patients had baseline testosterone levels < 50 ng/mL.
Vsi bolniki so imeli ravni testosterona ob izhodišču < 50 ng/ml.
This procedure will take 3 to 4 hours (see section “Steps before Provenge treatment” below).
Ta postopek traja 3 do 4 ure (glejte poglavje "Koraki pred zdravljenjem z zdravilom Provenge" spodaj).
b Hazard ratio based on the unadjusted Cox Model.
b Razmerje tveganja na podlagi neprilagojenega Coxovega modela.
Since this medicine will be given by a qualified doctor or nurse, they are responsible for the correct disposal of the product.
Ker bo zdravilo predano usposobljenemu zdravniku ali medicinski sestri, sta odgovorna za pravilno odstranitev zdravila.
No data are available for these patients.
Podatki za te bolnike niso na voljo.
The first infusion of Provenge will be given approximately 3 days after the cell collection and will last approximately 1 hour (see also section 2 “Warnings and precautions”).
Prvo infuzijo zdravila Provenge boste prejeli približno 3 dni po odvzeli celic in bo trajala približno 1 uro (glejte tudi poglavje 2 "Opozorila in previdnostni ukrepi").
This test will determine whether you have enough blood cells to allow the leukapheresis procedure to be safely carried out.
S tem testom se določi, ali imate dovolj krvnih celic za varno izvedbo postopka levkafereze.
In case of using premedication, the status of the patient and possible contraindications/interactions should be taken into account.
V primeru uporabe premedikacije je treba upoštevati stanje bolnika in možne kontraindikacije/medsebojno delovanje.
Additionally, there is the small possibility/risk of transmitting infectious viruses to a patient if he is not the intended recipient of the product.
Dodatno obstaja tudi majhna možnost/tveganje za prenos kužnih virusov na bolnika, če ni prejemnik, ki mu je to zdravilo namenjeno.
Concurrent use of immunosuppressive agents (such as systemic corticosteroids) may alter its efficacy and/or safety.
Sočasna uporaba imunosupresivov (kot so sistemski kortikosteroidi) lahko spremeni njegovo učinkovitost in/ali varnost.
• A heart condition including blocked blood vessels which could lead to a heart attack
• bolezen srca, vključno z zamašenimi krvnimi žilami, kar lahko povzroči srčni napad
Overall survival Median, months (95% CI) Hazard ratio (95% CI)
Celokupno preživetje Mediana, meseci (95-% IZ) Razmerje tveganj (95-% IZ)
The doses of paracetamol and antihistamine given should be in accordance with local practice.
Odmerka paracetamola in antihistaminika je treba dati v skladu z lokalno prakso.
It is recommended that the minimum interval between leukapheresis procedures should not be less than 2 weeks.
Priporoča se, da čas med postopki levkafereze znaša najmanj 2 tedna.
Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX17.
Farmakoterapevtska skupina: Imunostimulanti, drugi imunostimulanti, oznaka ATC: L03AX17.
The entire volume of the infusion bag should be used.
Uporabiti je treba celotno količino infuzijske vrečke.
If you experience any of the following side effects several days after the infusion, contact a doctor immediately:
Če se pojavi kateri koli od naslednjih neželenih učinkov več dni po infundiranju, se takoj posvetujte z zdravnikom:
Final study report by 31 December 2020
Končno poročilo študije do 31. decembra 2020
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
IMPACT study
Študija IMPACT
Educational material for patients and/or carers to explain:
Izobraževalno gradivo za bolnike in / ali oskrbovalno osebje, ki pojasnjuje:
You can also report any side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
After removal from the insulated container
Po odstranitvi iz izoliranega vsebnika
It consists of immune cells (part of your body's natural defense system) taken from your own blood (also called autologous immune cells).
Sestavljajo ga imunske celice (del naravnega obrambnega sistema telesa), pridobljene iz vaše krvi (imenovane tudi avtologne imunske celice).
No specific dose recommendation can be provided in these patients.
Specifičnega priporočila za odmerjanje pri teh bolnikih ni mogoče dati.
What Provenge is and what it is used for
Kaj je zdravilo Provenge in za kaj ga uporabljamo
In addition to antigen presenting cells (APCs), the final product thus contains T cells, B cells, natural killer (NK) cells, and other cells.
Poleg antigen predstavljajočih celic (APC, antigen presenting cells) tako vsebuje končno zdravilo tudi celice T, celice B, naravne ubijalke (NK, natural killer) in druge celice.
This will be added to your Patient Alert Card that you should bring to each appointment.
Priložil ga bo vaši kartici z opozorili za bolnika, ki jo morate prinesti na vsak obisk.
Small clumps of cellular material should disperse with gentle manual mixing.
Majhne grudice celičnega materiala se morajo z nežnim ročnim mešanjem raziti.
Appropriate medical therapy should be administered as needed.
Uvesti je treba ustrezno terapijo z zdravili, kot je potrebno.
Therefore, vaccinations with live attenuated or inactivated vaccines whilst receiving Provenge should be carefully considered.
Zato je treba cepljenje z živimi oslabljenimi ali inaktiviranimi cepivi med prejemanjem zdravila Provenge skrbno pretehtati.
Patients should be observed for at least 30 minutes following each infusion.
Bolnike je treba opazovati vsaj 30 minut po vsakem infundiranju.
Your blood will be tested before it is collected (see section “Tests” below).
Pred odvzemom bodo vaši kri testirali (glejte poglavje "Testi" spodaj).
If the final results show that your medicine was not sterile, your doctor will be notified and you will be monitored closely for any signs of infection and will be treated accordingly.
Če končni rezultati pokažejo, da vaše zdravilo ni bilo sterilno, bo o tem obveščen vaš zdravnik, ki bo pri vas skrbno spremljal znake okužbe in jih bo ustrezno zdravil.
Thirty-five percent of patients had undergone radical prostatectomy, 54% had received local radiotherapy, and 82% had received combined androgen blockade.
Petintrideset odstotkov bolnikov je imelo radikalno prostatektomijo, 54 % jih je prejelo lokalno radioterapijo in 82 % jih je prejelo kombinirano androgensko blokado.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c (7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Conventional reproductive and development toxicity studies are not considered relevant given the nature and the intended clinical use of this autologous cell therapy product.
Običajne študije vpliva na sposobnost razmnoževanja in razvojne toksičnosti niso pomembne glede na naravo in nameravano klinično uporabo tega zdravila iz avtolognih celic.
• a delay in Provenge reaching the clinic where you will be given your treatment.
• zamuda dostave zdravila Provenge na kliniko, kjer boste deležni zdravljenja
Your doctor may decide that Provenge is not suitable for you due to one or more of these conditions.
Vaš zdravnik se lahko odloči, da zdravilo Provenge zaradi enega ali več od obstoječih stanj za vas ni primerno.
Patients did not require opioid analgesics for pain management and the majority had not received prior chemotherapy.
Bolniki za obravnavo bolečin niso potrebovali opioidnih analgetikov, večina pa predhodno ni prejela kemoterapije.
Dose and course of treatment
Odmerek in potek zdravljenja
Figure 1 Kaplan-Meier overall survival curve, IMPACT study
Slika 1 Splošna krivulja preživetja po Kaplan-Meierju, študija IMPACT
Some serious infections and sepsis were related to the use of central venous catheters (CVCs).
Nekatere resne okužbe in sepsa so bili povezani z uporabo centralnih venskih katetrov (CVC, central venous catheter).
The risks and benefits of vaccinating patients during the course of treatment with Provenge have not been studied.
Tveganj in koristi cepljenja bolnikov med zdravljenjem z zdravilom Provenge niso preučili.