natgillin/translations-raw huggingface dataset:
According to the CHMP anticancer guideline (CPMP/EWP/205/95/Rev.3/Corr.
EMA/CHMP/735863/2009 rev. EMEA/H/A-29/1238
France
7. julij 2010
Applicant company name, address
Odgovori družbe, poslani dne:
Austria
18. marec 2010
The CHMP noted the submitted trials assessing the role of bendamustine in CLL, MM and rituximabrefractory NHL.
CHMP je ocenil dve klinični študiji, ki ju je družba predložila v podporo indikacijama multipli mielom in ne-Hodgkinov limfom.
A number of concerned member states raised potential serious risks to public health with regards to the efficacy of the medicinal product in these indications, considering that non-inferiority or superior efficacy when compared to the efficacy of well established chemotherapy regimens recommended in international guideline had not been demonstrated.
Podlaga za napotitev je bila, da ena država članica, Združeno kraljestvo, ni mogla odobriti indikacije ne-Hodgkinov limfom, dve državi članici, Belgija in Francija, pa nista mogli odobriti indikacije multipli mielom, saj ni bilo dovolj podatkov glede učinkovitosti tega zdravila pri teh indikacijah.
Levact contains bendamustine, an alkylating anti-tumour agent which acts by impairing DNA matrix functions and DNA synthesis and repair.
Zdravilna učinkovina v zdravilu Levact, bendamustin hidroklorid, spada v skupino zdravil proti raku, imenovanih „alkilirajoče učinkovine“.
Efficacy of bendamustine in multiple myeloma (MM)
Jean-François Baurain (Belgija)
Therefore, the CHMP considered that the benefit-risk ratio is positive for all applied indications, albeit with different degrees of certainty.
Odbor je tako priporočil odobritev dovoljenja za promet z zdravilom Levact v Nemčiji in v vseh zadevnih državah članicah za vse indikacije, za katere je bila vložena vloga.
SCIENTIFIC CONCLUSIONS
Soporočevalec:
The Applicant presented an abstract of the final analysis of a trial in first line setting, comparing bendamustine in combination with rituximab (B-R) to R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin (Adriamycin), Oncovin (vincristine), and prednisone) treatment, allowing the contribution of bendamustine vs CHOP to be deduced.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Levact odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Nemčiji ter v navedenih državah članicah EU: Avstrija, Belgija, Danska, Finska, Francija, Irska, Italija, Luksemburg, Norveška, Poljska, Španija in Združeno kraljestvo.
Finally, the Applicant noted the characteristic neurotoxicity profiles of recently authorised drugs and emphasized the non-overlapping and well-established toxicity profile of bendamustine (no neurotoxicity) for patients not eligible for thalidomide or bortezomib.
65 let, ki niso primerni za presaditev matičnih celic in jih ni mogoče zdraviti s talidomidom ali bortezomibom (drugima vrstama zdravil proti raku).
the CHMP has recommended the granting of the Marketing Authorisations 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 for Levact and associated names (see Annex I).
Evropska agencija za zdravila je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Levact in povezanih imen.
The CR rate was significantly higher for the B-R group (40.1 vs. 30.8%), PFS was higher (54.8 vs. 34.8 months) and the Hazard Ratio (HR) was 0.5765.
Vprašanja in odgovori v zvezi z zdravilom Levact in povezanimi imeniF F (bendamustin hidroklorid, 2,5 mg/ml, prašek za koncentrat za raztopino za infundiranje) EMA/CHMP/735863/2009
In conclusion, the CHMP adopted the following indications:
Uporablja se za zdravljenje naslednjih vrst raka:
International Non-proprietary Name (INN): Rubitecan
Mednarodno nelastniško ime (INN): rubitekan
Alkaloids are substances that are naturally found in plants.
Alkaloidi so snovi, ki so naravno prisotne v rastlinah.
However, if you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving you the treatment.
Če pa ste vključeni v klinično preizkušanje ali program sočutne uporabe ter potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
Orathecin was designated as an orphan medicinal product on 10 June 2003.
Zdravilo Orathecin je bilo 10. junija 2003 določeno kot zdravilo sirota.
London, 26 January 2006 Doc.Ref.
London, 26. januar 2006 Sklic dok.
No information has been given by the Company on the future development of the product.
Podjetje ni predložilo podatkov o prihodnjem razvoju zdravila.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for Orathecin
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo Orathecin
On 19 January 2006, EuroGen Pharmaceuticals Ltd officially notified the Agency's Committee for Medicinal Products for Human Use (CHMP) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan).
Podjetje EuroGen Pharmaceuticals Ltd je 19. januarja 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji, da so se odločili umakniti vlogo za dovoljenje za promet z zdravilom Orathecin (rubitekan).
When cells are growing, as in the case for cancer cells, the genetic material (DNA) inside the cell may become twisted.
Ko celice rastejo (kar se dogaja pri rakavih celicah), se lahko genetski material (DNA) v celici navije v navoje.
Link to the withdrawal letter.
Povezava do dopisa o umiku.
Link to withdrawal EMEA press release.
Povezava do tiskovnega sporočila EMEA o umiku.
This avoids that the DNA breaks, which would damage the cells.
S tem preprečijo lomljenje DNA, ki bi poškodovalo celice.
The CHMP was assessing the responses given by the Company to a list of questions.
CHMP je ocenjeval odgovore, ki jih je podjetje podalo na vprašanja s seznama vprašanj.
Orathecin has been investigated in two main clinical studies.
Zdravilo Orathecin so preizkusili v dveh glavnih kliničnih raziskavah.
Certain camptothecins are used in medicine as anti-cancer agents.
Določeni kamptotecini se uporabljajo v medicini kot zdravila proti raku.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Zato je bil v času umika CHMP mnenja, da koristni učinki niso bili zadostno dokazani in niso večji od znanih tveganj.
Orathecin contains 0.5 or 1.25 of the active substance rubitecan.
Zdravilo Orathecin vsebuje 0,5 mg ali 1,25 mg zdravilne učinkovine rubitekan.
In the studies presented by the Company, it could not be shown that Orathecin extends the life of patients nor improves their quality of life.
Raziskave, ki jih je predložilo podjetje, niso pokazale, da zdravilo Orathecin podaljša življenje bolnikov ali izboljša kakovost njihovega življenja.
This protein is called topoisomerase I. By blocking this protein, Orathecin is expected to damage the cancer cells.
Tej beljakovini pravimo topoizomeraza I. Z blokiranjem te beljakovine naj bi zdravilo Orathecin poškodovalo rakave celice.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orathecin?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe z zdravilom Orathecin?
Moreover, patients treated with Orathecin experienced many side effects, including serious ones.
Razen tega so imeli bolniki, ki so bili zdravljeni z zdravilom Orathecin, veliko neželenih učinkov, vključno z resnimi neželenimi učinki.
The effects of orathecin were first tested in experimental models before being studied in humans.
Učinki zdravila Orathecin so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
Orathecin belongs to a group of alkaloids called camptothecins.
Zdravilo Orathecin spada v skupino alkaloidov, ki jim pravimo kamptotecini.
Based on the review of the data and the Company's response to the CHMP list of questions, at the time the withdrawal, the CHMP had concerns and was of the provisional opinion that Orathecin could not be approved for treatment of patients with advanced or metastatic pancretic cancer.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo ni mogoče odobriti dovoljenja za zdravljenje bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
The Company informed the Agency that at the time of the withdrawal, all clinical trials in the European Union are closed to enrolment and there is no ongoing compassionate use programmes.
Podjetje je obvestilo Evropsko agencijo za zdravila, da se v času umika v nobeno klinično preizkušanje v Evropski uniji več ne vključuje bolnikov ter da programi sočutne uporabe ne potekajo več.
The application was at Day 172 days, when the Company withdrew it.
Podjetje je umaknilo vlogo na dan 172.
Orathecin was to be used to treat patients with advanced cancer of the pancreas, who cannot be operated or who have metastasis (cancer cells that spread from the original site to other parts of the body), and who do not respond to the other anticancer drugs used for the treatment of their disease.
Zdravilo Orathecin naj bi se uporabljalo za zdravljenje bolnikov z napredovalim rakom trebušne slinavke, pri katerih kirurški poseg ni možen ali pa imajo metastaze (rakave celice, ki so se zasejale izven prvotnega mesta v drugih delih telesa) in ki se ne odzivajo na druga zdravila proti raku, ki se uporabljajo za zdravljenje te bolezni.
Following CHMP opinion, it usually takes around 2 months to the European Commission to give a licence.
Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
The studies included approximately 800 patients with advanced or metastatic cancer of the pancreas.
V raziskave je bilo vključenih približno 800 bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
Orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore.
Zdravilo Orathecin so dajali bolnikom, dokler rak ni napredoval ali dokler niso več prenesli zdravljenja.
What documentation has been presented by the Company to support the application to the CHMP?
Kakšno dokumentacijo je podjetje predložilo CHMP za podkrepitev svoje vloge?
The studies looked at how long the patients survived after receiving orathecin, compared to those receiving the standard medicines used to treat pancreatic cancer, including 5-fluorouracil (5-FU) or gemcitabine.
Čas preživetja teh bolnikov so primerjali s časom preživetja bolnikov, ki so prejemali zdravila, ki se običajno uporabljajo za zdravljenje raka trebušne slinavke, med drugim 5-fluorouracil (5-FU) ali gemcitabin.
Camptothecins are able to block one of the proteins that can remove twists in the DNA.
Kamptotecini lahko blokirajo eno izmed beljakovin, ki odvijajo navoje na DNA.
Orathecin is a capsule to be taken orally.
Zdravilo Orathecin so kapsule, ki se jemljejo peroralno.
What is Orathecin?
Kaj je zdravilo Orathecin?
The indication applied for was the treatment of patients with advanced or metastatic pancretic cancer.
Indikacija, navedena v vlogi, je bila zdravljenje bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
What was Orathecin expected to be used for?
Za kaj naj bi se zdravilo Orathecin uporabljalo?
Once the Company has supplied responses to the questions, the CHMP reviews them and may, before give an opinion, ask any remaining questions (at day 180) to the Company.
Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za
How is Orathecin expected to work?
Kako naj bi zdravilo Orathecin delovalo?
Cells have several proteins, which help to remove any twists in the DNA.
Celice imajo več beljakovin, ki odvijajo navoje na DNA.
The recommended dose is one capsule taken three times a day.
Priporočeni odmerek je ena kapsula trikrat na dan.
Patients should be assessed every six months and treatment should be stopped if no improvement is seen.
Bolnike je treba ocenjevati vsakih šest mesecev in zdravljenje prekiniti, če ni vidnega izboljšanja.
No major safety concerns were identified, and the possible risk of bleeding can be minimised with appropriate precautions.
Večjih varnostnih zadržkov niso ugotovili, morebitno tveganje za krvavitev pa se lahko zmanjša z ustreznimi previdnostnimi ukrepi.
What measures are being taken to ensure the safe and effective use of Elmiron?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Elmiron?
The full EPAR for Elmiron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Elmiron je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bladder pain syndrome is a distressing condition for which no medicines were previously approved in the EU.
Sindrom bolečega mehurja je mučno stanje, za katero v EU še ni bilo odobrenih zdravil.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Elmiron's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Elmiron večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Elmiron.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Elmiron.
This reinforcement of the protective layer may reduce inflammation and bladder pain.
Okrepitev zaščitnega sloja morda zmanjša vnetje in bolečino v mehurju.
Other information about Elmiron
Druge informacije o zdravilu Elmiron
The studies involved a total of 454 patients with small bleeds and lesions in the bladder wall.
Študije so skupaj vključevale 454 bolnikov z majhnimi krvavitvami in lezijami na steni mehurja.
Because pentosan polysulfate sodium is a well-known substance, and its use in bladder pain syndrome is well established, the company for Elmiron presented data from the scientific literature.
Ker je natrijev pentosan polisulfat dobro znana snov in njegova uporaba pri sindromu bolečega mehurja dobro uveljavljena, je družba za zdravilo Elmiron predložila podatke iz znanstvene literature.
Since Elmiron may have a weak anticoagulant effect (i.e. it may stop the blood from clotting properly), it must not be used in patients who actively bleed (but this does not include women during menstrual cycle).
Ker ima zdravilo Elmiron šibek antikoagulacijski učinek (kar pomeni, da lahko prepreči pravilno strjevanje krvi), se ne sme uporabljati pri bolnikih z aktivno krvavitvijo (kar pa ne vključuje žensk v času menstruacije).
A review of 4 main studies from the literature showed that pentosan polysulfate sodium is effective at reducing symptoms, such as pain and the urge to pass urine frequently.
Pregled štirih glavnih študij iz literature je pokazal, da je natrijev pentosan polisulfat učinkovit pri zmanjševanju simptomov, kot sta bolečina in nujnost pogostega uriniranja.
Looking at the results of the 4 studies together, 1 in 3 (33%) patients taking pentosan polysulfate sodium showed an overall improvement in their condition compared with around 1 in 6 (16%) patients taking placebo (a dummy treatment).
Skupna analiza rezultatov štirih študij je pokazala, da je do skupnega izboljšanja stanja prišlo pri 1 od 3 (33 %) bolnikov, ki so jemali natrijev pentosan polisulfat, v primerjavi s približno 1 od 6 (16 %) bolnikov, ki so jemali placebo (zdravilo brez zdravilne učinkovine).
What benefits of Elmiron have been shown in studies?
Kakšne koristi je zdravilo Elmiron izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elmiron have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Elmiron upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Elmiron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Elmiron preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Elmiron pentosan polysulfate sodium
Elmiron natrijev pentosan polisulfat
What are the risks associated with Elmiron?
Kakšna tveganja so povezana z zdravilom Elmiron?
Elmiron is available as 100-mg capsules and can only be obtained with a prescription.
Zdravilo Elmiron je na voljo v obliki 100-miligramskih kapsul, njegovo predpisovanje in izdaja pa je le na recept.
What is Elmiron and what is it used for?
Kaj je zdravilo Elmiron in za kaj se uporablja?
The most common side effects with Elmiron (which may affect up to 1 in 10 people) include headache, dizziness, and effects in the digestive systems such as diarrhoea, nausea (feeling sick), abdominal (belly) pain and bleeding from the rectum.
Najpogostejši neželeni učinki zdravila Elmiron (ki se lahko pojavijo pri več kot 1 bolniku od 10) vključujejo glavobol, omotico in učinke na prebavila, kot so driska, navzeja (siljenje na bruhanje), bolečine v trebuhu in krvavitev iz danke.
For practical information about using Elmiron, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Elmiron naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
In patients with small bleeds and lesions in the bladder wall, treatment with Elmiron led to significantly more patients having an overall improvement in symptoms.
Kar zadeva bolnike z majhnimi krvavitvami in lezijami na steni mehurja, so se simptomi pri zdravljenju z zdravilom Elmiron skupno izboljšali pri velikem številu bolnikov.
Why is Elmiron approved?
Zakaj je bilo zdravilo Elmiron odobreno?
Elmiron is used in patients with moderate to severe pain and who have small bleeds or lesions (sores) in the bladder wall.
Zdravilo Elmiron se uporablja pri bolnikih z zmerno do hudo bolečino, ki imajo majhne krvavitve ali lezije (razjede) na steni mehurja.
It is not intended to provide practical advice on how to use Elmiron.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects and restrictions with Elmiron, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Elmiron glejte navodilo za uporabo.
Elmiron is a medicine used to treat adults with bladder pain syndrome, a condition of the bladder which causes pain in the pelvic area and a frequent, urgent need to pass urine.
Zdravilo Elmiron se uporablja za zdravljenje odraslih s sindromom bolečega mehurja, boleznijo mehurja, ki povzroča bolečino v medeničnem predelu ter pogosto in nujno potrebo po uriniranju.
Elmiron contains the active substance pentosan polysulfate sodium.
Zdravilo Elmiron vsebuje zdravilno učinkovino natrijev pentosan polisulfat.
The way the active substance in Elmiron, pentosan polysulfate sodium, works is not fully understood but it passes into the urine and is thought to attach to and help repair the protective layer of mucus lining the bladder, which is deficient in patients with bladder pain syndrome.
Delovanje zdravilne učinkovine zdravila Elmiron, natrijevega pentosan polisulfata, ni v celoti znano, vendar prehaja v urin in naj bi se pritrdila na zaščitni sloj sluznice mehurja, ki je pri bolnikih s
How does Elmiron work?
Kako zdravilo Elmiron deluje?
How is Elmiron used?
Kako se zdravilo Elmiron uporablja?
In most cases you will need a doctor.
V večini primerov boste potrebovali zdravnika.
Always check both dates!
Vedno preverite oba datuma!
Tell your relatives, friends and close colleagues the following:
Sorodnikom, prijateljem in bližnjim sodelavcem povejte naslednje:
Your dose number may be different than the one in this example.
Številka vašega odmerka bo morda drugačna od tiste, ki je prikazana v tem primeru.
• Always carry some sugar (at least 20 grams) with you.
• Pri sebi vedno imejte nekaj sladkorja (vsaj 20 gramov).
Wash your hands before continuing.
Preden nadaljujete, si umijte roke.
These include:
Ti dejavniki vključujejo:
This step helps to ensure that you will get your full dose later on.
Ta korak pomaga zagotoviti, da boste kasneje prejeli celoten odmerek.
Be careful when you start or stop taking another medicine.
Previdni bodite, kadar začnete ali prenehate uporabljati katero drugo zdravilo.
If it does not work, you will need to try with a new needle.
Če ne deluje, boste morali poskusiti z novo iglo.
• Keep it away from direct heat and light.
• Zaščitite ga pred neposredno vročino in svetlobo.
These injections are justified even if it is not certain that you have hypoglycaemia.
Uporaba teh injekcij je upravičena tudi, če ni gotovo, da imate hipoglikemijo.
Always tell people who are caring for you or treating you that you require insulin.
Osebam, ki za vas skrbijo ali vas zdravijo, vedno povejte, da potrebujete insulin.
It may take up to five tries.
Morda boste morali poskusiti tudi do petkrat.
The potency of this medicinal product is stated in units.
Jakost tega zdravila je navedena v enotah.
Glucose Utilization Rate* (mg/kg/min)
Hitrost porabljanja glukoze* (mg/kg/min)
Do not use it after this time period.
Po tem času ga ne uporabljajte več.
Do not stop LUSDUNA without speaking to a doctor, who will tell you what needs to be done.
Ne prenehajte uporabljati zdravila LUSDUNA, ne da bi se posvetovali z zdravnikom, ki vam bo povedal, kaj je treba storiti.
Be familiar with your warning symptoms.
Poznajte svoje opozorilne simptome.
This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
To lahko predstavlja tveganje v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avtomobila ali upravljanju s stroji).
In your body
V telesu
For storage conditions after removing this medicinal product from the refrigerator, see section 6.3.
Za pogoje shranjevanja po tem, ko se zdravilo vzame iz hladilnika, glejte poglavje 6.3.
Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage.
Nemudoma zaužijte približno 10 do 20 gramov sladkorja, na primer v obliki glukoze, kock sladkorja ali s sladkorjem sladkane pijače.
This kills germs that might make you sick.
To uniči bakterije, zaradi katerih bi lahko zboleli.
You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Običajno bi morali biti zmožni prepoznati, ko se vam krvni sladkor preveč zniža, tako da lahko pravilno ukrepate.
• Your doctor or nurse will show you how to use your pen.
• Zdravnik ali medicinska sestra vam bosta pokazala, kako uporabljati injekcijski peresnik.
Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby.
Posebno skrbno spremljanje vaše sladkorne bolezni in preprečevanje hipoglikemij sta pomembna za zdravje vašega otroka.
Careful monitoring of glucose control is essential.
Natančno spremljanje urejenosti glukoze je ključnega pomena.
Repeat until you see insulin
Ponavljajte, dokler ne zagledate insulina
See Step 9 for how to remove a needle.
Glejte 9. korak o tem, kako odstranite iglo.
Check your insulin
Preverite svoj insulin
Your doctor will show you in which area of the skin you should inject LUSDUNA.
Zdravnik vam bo pokazal, v kateri predel kože morate injicirati zdravilo LUSDUNA.