natgillin/translations-raw huggingface dataset:
This is called ‘dose dumping' and could put patients at risk of exposure to large doses of the opioid, leading to side effects such as respiratory depression (an inhibition of breathing).
Ta pojav se imenuje prekomerno sproščanje in zaradi njega so lahko bolniki izpostavljeni tveganju zaradi velikih odmerkov opioida, kar lahko povzroči neželene učinke, na primer respiratorno depresijo (zmanjšanje dihanja).
• Prescribers of modified-release opioids and their patients should be aware of the potential interaction between these medicines and alcohol.
• Zdravniki, ki predpisujejo opioide s prirejenim sproščanjem, in njihovi bolniki se morajo zavedati možnega medsebojnega delovanja teh zdravil z alkoholom.
However, studies looking at the drinking behaviour of patients with severe pain show that many patients drink alcohol while being treated with strong opioids.
Vendar pa so študije, v katerih so preučevali navade pitja pri bolnikih s hudo bolečino, pokazale, da veliko bolnikov pri zdravljenju z močnimi opioidi pije alkohol.
The CHMP used the results of these studies to predict what would happen if these medicines were taken with alcohol.
CHMP je rezultate teh študij uporabil za napoved, kaj bi se zgodilo, če bi se ta zdravila jemala skupaj z alkoholom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of most of these medicines continue to outweigh their risks, but that warnings on the use of these medicines together with alcohol should be made consistent across the class.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi večine teh zdravil še vedno odtehtajo z njimi povezana tveganja, vendar je treba za celotno skupino dosledno navajati opozorila glede uporabe teh zdravil skupaj z alkoholom.
break down slowly in the body or limit the active substance's release, such as cellulose-based substances and polymers.
razgrajujejo ali omejujejo sproščanje zdravilne učinkovine, kot so snovi na osnovi celuloze in polimeri.
The CHMP also took information from studies looking at the drinking habits of patients with severe pain into account.
CHMP je upošteval tudi informacije iz študij, v katerih so preučevali navade pitja pri bolnikih s hudimi bolečinami.
Because some of the chemicals used in the controlled-release systems dissolve in alcohol, there is a theoretical possibility that taking these medicines together with alcohol may cause the active substance to be released too quickly.
Ker so nekatere od kemičnih snovi, ki se uporabljajo pri sistemih za nadzorovano sproščanje, topne v alkoholu, je teoretično mogoče, da bi jemanje teh zdravil skupaj z alkoholom lahko povzročilo prehitro sproščanje zdravilne učinkovine.
However, the CHMP noted that all medicines in this class have the potential to interact with alcohol, such as increasing the opioids' sedative effects.
Vendar pa je CHMP tudi menil, da lahko vsa zdravila v tem razredu medsebojno delujejo z alkoholom, na primer povečajo pomirjevalni učinek opioidov.
Oral opioid medicines of the WHO level III scale for the management of pain are strong painkillers that are taken by mouth and used to treat intense pain that has not been controlled sufficiently with other medicines.
Peroralna opioidna zdravila III. stopnje po lestvici SZO za obvladovanje bolečine so močna protibolečinska zdravila, ki se pogoltnejo in se uporabljajo za zdravljenje močne bolečine, ki je z drugimi zdravili ni mogoče ustrezno obvladovati.
These medicines were reviewed following concerns that alcohol might have an effect on the way they release the active substance in the body.
Zdravila so bila pregledana po tem, ko so se pojavili zadržki, da lahko alkohol vpliva na način sproščanja zdravilne učinkovine v telesu.
These suspensions will remain in force until the companies that make these medicines have reformulated them so that they are more stable in alcohol.
Začasni umiki bodo veljali, dokler družbe, ki proizvajajo ta zdravila, ne spremenijo njihovih formulacij tako, da bodo stabilnejša v alkoholu.
Therefore, the Committee recommended that the marketing authorisations for these medicines should be suspended until the companies that make these medicines have reformulated the medicines so that they are more stable in alcohol.
Zato je Odbor priporočil, da se dovoljenja za promet s temi zdravili začasno umaknejo, dokler družbe, ki ta zdravila proizvajajo, ne spremenijo njihovih formulacij, tako da bodo stabilnejša v alkoholu.
The CHMP concluded that around half of the controlled-release systems tested showed a slight increase in the amount of active substance they released when placed in an alcohol solution, but that this effect was mild and would only have a minor effect on the release of the active substance.
CHMP je ugotovil, da se je pri približno polovici testiranih sistemov za nadzorovano sproščanje pokazalo majhno povečanje količine zdravilne učinkovine, ki se je sprostila ob umestitvi sistemov v alkoholno raztopino, vendar pa je bil ta učinek blag in bi imel le majhen vpliv na sproščanje zdravilne učinkovine.
However, for one of the controlled-release systems tested - once-daily capsules using a polymethacrylate-triethylcitrate coating to control the release of morphine - there was a significant interaction with alcohol.
Pri enem testiranem sistemu za nadzorovano sproščanje - kapsulah s prevleko iz polimetakrilat-trietilcitrata za nadzorovanje sproščanja morfina, ki se jemljejo enkrat na dan - pa se je pojavilo pomembno medsebojno delovanje z alkoholom.
This ladder gives recommendations on the order in which painkillers of increasing strength should be used to control a patient's pain1.
Lestvica daje priporočila o tem, v kakšnem vrstnem redu glede na naraščajočo jakost se morajo pri bolnikih za obvladovanje bolečine uporabljati protibolečinska zdravila1.
The CHMP reviewed the results of laboratory studies looking at the way that controlled-release systems act when they are placed in solutions containing alcohol.
CHMP je pregledal rezultate laboratorijskih študij, ki so preučevale način delovanja sistemov za nadzorovano sproščanje v primerih, kadar so postavljeni v raztopine z alkoholom.
Questions and answers on the review of modified-release oral opioid medicines of the WHO level III scale for the management of pain
Vprašanja in odgovori glede pregleda peroralnih opioidnih zdravil s prirejenim sproščanjem III. stopnje po lestvici SZO za obvladovanje bolečine
Therefore, the CHMP concluded that modified-release opioids using the polymethacrylate-triethylcitrate controlled-release system are highly sensitive to alcohol and that there is a risk of dose dumping if patients drink alcohol while taking them.
Zato je CHMP sklenil, da so opioidi s prirejenim sproščanjem, pri katerih se uporablja sistem za nadzorovano sproščanje s polimetakrilat-trietilcitratom, zelo občutljivi na alkohol in da obstaja tveganje prekomernega sproščanja, če bolniki ob jemanju teh opioidov pijejo alkohol.
However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system', the Committee concluded that the marketing authorisations should be suspended.
Vendar pa je Odbor glede zdravil s prirejenim sproščanjem, ki vsebujejo „sistem za nadzorovano sproščanje s polimetakrilat-trietilcitratom“, sklenil, da je treba dovoljenja za promet z zdravilom začasno umakniti.
They are called ‘WHO level III scale' medicines as they are on the highest step of the World Health Organization's three-step pain relief ladder.
stopnje po lestvici SZO“, saj so na najvišji stopnji tristopenjske lestvice Svetovne zdravstvene organizacije za lajšanje bolečin.
The European Medicines Agency has completed a review of the safety and effectiveness of modifiedrelease oral opioid medicines of the WHO level III scale for the management of pain.
Evropska agencija za zdravila je zaključila pregled varnosti in učinkovitosti peroralnih opioidnih zdravil s prirejenim sproščanjem III. stopnje po lestvici SZO za obvladovanje bolečine.
They should consider switching patients currently taking opioids containing the polymethacrylate-triethylcitrate controlled-release system to alternatives while the suspension is in force.
Upoštevati morajo, da je treba pri bolnikih, ki trenutno jemljejo opioide, ki vsebujejo sistem za nadzorovano sproščanje s polimetakrilat-trietilcitratom, v obdobju začasnega umika dovoljenja za promet te opioide zamenjati z nadomestnimi zdravili.
What are modified-release oral medicines of the WHO level III scale for the management of pain?
Kaj so peroralna zdravila s prirejenim sproščanjem III. stopnje po lestvici SZO za obvladovanje bolečine?
A European Commission decision on this opinion will be issued in due course.
Evropska komisija je odločbo izdala dne 20. aprila 2011.
Modifiedrelease tablets and capsules are made by combining the active substance with other substances that
To zmanjša število odmerkov, ki jih mora bolnik vzeti vsak dan. Tablete in kapsule s prirejenim sproščanjem vsebujejo kombinacijo zdravilne učinkovine in drugih snovi, ki se v telesu počasi
Companies responses provided on: 25 January 2010, 4 May 2010 and 2 July 2010 Opinion date:
Po ponovnem pregledu je Odbor dne 18. novembra 2010 ta priporočila potrdil.
Member State in EEA
Država članica EU/EGP
Product name
Izmišljeno ime
Pharmaceutical form Route of administration
Farmacevtska oblika Pot uporabe zdravila
Human Medicines Evaluation Division
Imetnik dovoljenja za promet z zdravilom
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for flupirtine-containing medicinal products
Priloga I Seznam zdravil in oblik
Flupirtinmaleat Tamarang
Flupirtinmaleat Tamarang flupirtinijev maleat 100 mg kapsula
This plan shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about: a) The intravitreal procedure as it was performed in the pivotal clinical studies b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events
Ta program mora biti sestavljen iz ukrepov, katerih cilj je kar najbolj zmanjšati neželene dogodke, povezane s postopkom intravitrealnega injiciranja (npr. endoftalmitisa), prek ustreznega izobraževanja o: a) intravitrealnem postopku, kot so ga opravljali v ključnih kliničnih študijah b) sterilnih tehnikah za zmanjševanje tveganja okužbe na najmanjšo mogočo mero c) uporabi antibiotikov d) uporabi povidon jodida e) opravljanju čiščenja vek f) uporabi anestetika za preprečevanje neprijetnosti postopka za bolnika g) tehnikah intravitrealnega injiciranja h) urejanju intraokularnega tlaka (IOP - »intraocular pressure«) i) zdravljenju endoftalmitisa j) poznavanju dejavnikov tveganja za nastanek endoftalmitisa k) prijavljanju resnih neželenih dogodkov
• An educational plan for patients which is aimed at risk minimisation and to support safe and effective use for the product.
• Izobraževalni program za bolnike, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider
Ta program mora biti sestavljen iz ukrepov za ustrezno izobraževanje glede: l) ključnih znakov in simptomov resnih neželenih dogodkov, povezanih s postopkom injiciranja v steklovino m) tega, kdaj naj bolnik poišče urgentno pomoč zdravstvenega delavca.
• An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product.
• Izobraževalni program za zdravnike in zdravstvene delavce, katerega namen je zmanjševanje tveganj na najmanjšo mogočo mero in podpora varni in učinkoviti uporabi zdravila.
¾ The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) prior to marketing.
¾ Države članice morajo zagotoviti, da bodo v izobraževalne programe za zdravnike, zdravstvene delavce in bolnike vključeni ukrepi od a) do m), kot je navedeno v nadaljevanju, in da bodo ti programi primerni za cilj kar najbolj učinkovitega zmanjševanja neželenih dogodkov, povezanih s postopkom intravitrealnega injiciranja (npr. endoftalmitisa), pred dajanjem zdravila v promet.
84 x 1 capsules (unit dose)
84 x 1 kapsul (posamični odmerek)
100 mg Capsule, hard Oral use blister (PVC/ PCTFE/Alu)
100 mg kapsula, trda peroralna uporaba pretisni omot (PVC/PCTFE/alu)
EMA Number
Številka EMA
Yargesa
Jakost
Immediate Packaging
Pot uporabe Stična ovojnina Velikost pakiranja
Similar results were seen after a year.
Podobne rezultate so opazili tudi po enem letu.
This summary was last updated in 10-2008.
Povzetek je bil nazadnje posodobljen 10-2008.
The marketing authorisation was renewed on 9 October 2003 and on 9 October 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 9. oktobra 2003 in 9. oktobra 2008.
Other information about Simulect:
Druge informacije o zdravilu Simulect:
The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998.
Evropska komisija je dovoljenje za promet z zdravilom Simulect, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 9. oktobra 1998.
The main measure of effectiveness was the number of treatment failures (death, loss of the new kidney or signs of rejection) over the first year after the transplant.
Glavno merilo učinkovitosti je bilo število neuspelih zdravljenj (smrt, izguba nove ledvice ali znaki zavrnitve) v prvem letu po presaditvi.
Simulect was more effective than placebo.
Zdravilo Simulect je bilo učinkovitejše od placeba.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SIMULECT EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) SIMULECT Povzetek EPAR za javnost
Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant.
Zdravilo Simulect so proučevali v treh glavnih študijah, ki so vključevale skupaj 1 067 odraslih, pri katerih je bila opravljena presaditev ledvice.
Simulect is given as two injections.
Zdravilo Simulect se daje v obliki dveh injekcij.
The Committee recommended that Simulect be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Simulect odobri dovoljenje za promet.
The first injection should be given a maximum of two hours before transplantation surgery, and the second four days after the transplant, unless the patient has had a severe hypersensitivity (allergic) reaction or has complications after the operation, such as loss of the new kidney.
Prvo injekcijo je treba dati največ dve uri pred kirurškim posegom presaditve, drugo pa štiri dni po presaditvi, razen če se pri bolniku ne pojavijo hude preobčutljivostne (alergijske) reakcije ali se po posegu pojavijo zapleti, kot so izguba nove ledvice.
The studies in children and adolescents showed that the lower dose of Simulect was appropriate for children, and that adolescents could use the adult dose.
Študije pri otrocih in mladostnikih so pokazale, da je za otroke primeren manjši odmerek zdravila Simulect in da mladostniki lahko uporabljajo odmerek za odrasle.
It should be given under qualified medical supervision.
Zdravilo se mora dajati pod strokovnim medicinskim nadzorom.
What benefit has Simulect shown during the studies?
Kakšne koristi je zdravilo Simulect izkazalo med študijami?
Simulect should not be given unless it is absolutely certain that the patient will receive the transplant and other medicines to prevent rejection.
Zdravilo Simulect bolnik ne sme prejeti, če ni popolnoma gotovo, da bo dobil presadek in druga zdravila za preprečitev zavrnitve.
This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.
Tako se zmanjša število aktiviranih limfocitov T in s tem tudi tveganje zavrnitve presadka.
Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
Iz rezultatov prvih dveh študij skupaj je razvidno, da zdravljenje v šestih mesecih ni uspelo pri 40 % bolnikov, ki so zdravilo Simulect prejemali poleg dvotirnega zdravljenja (145 od 363), v primerjavi s 56 % bolnikov, ki so prejemali placebo (201 od 359).
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je zasnovano tako, da prepozna in se veže na določeno strukturo (imenovano antigen), ki se nahaja na določenih celicah telesa.
Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant.
Zdravilo Simulect lahko predpiše le zdravnik, ki ima izkušnje z imunosupresivnim zdravljenjem po presaditvi organov.
What is the risk associated with Simulect?
Kakšna tveganja so povezana z zdravilom Simulect?
Simulect is given into a vein, either as a ‘bolus' injection (given all at once) or as an infusion over 20 to 30 minutes.
Zdravilo Simulect se daje v veno bodisi kot „bolusna“ injekcija (bolnik prejme celo injekcijo naenkrat) ali kot infuzija, ki traja 20 do 30 minut.
Simulect is used in adults and children aged over one year, to prevent the body from rejecting a newly transplanted kidney.
Zdravilo Simulect se uporablja pri odraslih in otrocih, starejših od enega leta, za preprečevanje zavrnitve nove ledvice po presaditvi.
In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘dual therapy'), with some patients also taking azathioprine or mycophenolate mofetil.
V prvih dveh študijah je večina od 722 bolnikov jemala tudi ciklosporin in kortikosteroide (dvotirno zdravljenje), nekateri bolniki pa so jemali tudi azatioprin ali mofetilmikofenolat.
In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Najpogostejši neželeni učinki pri odraslih (opaženi pri več kot 20 % bolnikov) so bili zapeka, okužbe sečil (okužbe struktur, po katerih se prenaša urin), bolečine, občutek slabosti, periferni edem (oteklina), hipertenzija (povišan krvni tlak), anemija (majhno število rdečih krvnih celic), glavobol, hiperkaliemija (visoke ravni kalija v krvi), hiperholesterolemija (visoke ravni holesterola v krvi), pooperativni zapleti ran, povečanje telesne mase, zvišana vrednost kreatinina v krvi (označevalec ledvičnih težav), hipofosfatemija (nizke ravni fosfata v krvi), driska in okužbe zgornjih dihal (prehladi).
In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses.
Pri otrocih, ki tehtajo manj kot 35 kg, celotni odmerek znaša 20 mg, ki se daje v obliki dveh odmerkov po 10 mg.
In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses.
Pri odraslih in otrocih, ki tehtajo več kot 35 kg, je priporočeni celotni odmerek 40 mg, ki ga bolnik prejme kot dva odmerka po 20 mg.
Two additional studies looked at how Simulect is handled in the body when it is given to children aged over one year or to adolescents.
V dveh dodatnih študijah so opazovali, kakšni so odzivi na zdravilo Simulect v telesu otrok, starejših od enega leta, ali mladostnikov.
Simulect should not be used in people who may be hypersensitive to basiliximab or any of the other ingredients.
Zdravila Simulect ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za baziliksimab ali katero koli drugo sestavino zdravila.
In the studies, side effects were similar in patients taking Simulect and those receiving placebo, in combination with other medicines.
Neželeni učinki v študijah so bili podobni pri bolnikih, ki so jemali zdravilo Simulect in placebo v kombinaciji z drugimi zdravili.
In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘triple therapy').
V tretji študiji je vseh 345 odraslih jemalo ciklosporin, steroide in azatioprin (trotirno zdravljenje).
Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants).
Učinkovina baziliksimab je bila zasnovana tako, da se veže na antigen, imenovan CD25, ki je prisoten na površini limfocitov T (vrste belih krvničk, ki sodeluje pri zavrnitvi presajenih organov).
The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Simulect za zaščito pred akutno zavrnitvijo organa pri de novo alogeni presaditvi ledvice pri odraslih bolnikih in otrocih večje od z njim povezanih tveganj.
In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
V tretji študiji je bilo število bolnikov, pri katerih je bilo zdravljenje neuspešno, manjše pri bolnikih, ki so prejemali zdravilo Simulect sočasno s trotirnim zdravljenjem (26 %), kot pri bolnikih, ki so prejemali placebo (40 %).
Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein).
Zdravilo Simulect je prašek in vehikel, ki se uporabljata za pripravo raztopine za injiciranje ali infundiranje (vnašanje tekočine v veno po kapljicah).
Why has Simulect been approved?
Zakaj je bilo zdravilo Simulect odobreno?
For the full list of all side effects reported with Simulect, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Simulect, glejte navodilo za uporabo.
Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil.
Zdravilo Simulect se uporablja v kombinaciji z drugimi zdravili, kot so ciklosporin, kortikosteroidi, azatioprin in mofetilmikofenolat, za preprečevanje zavrnitve organov.
By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the lymphocytes multiply.
Baziliksimab z vezanjem na CD25 blokira aktivnost interlevkina-2 in tako zmanjša hitrost, s katero se limfociti razmnožujejo.
CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide.
CD25 je receptor za sporočilno molekulo interlevkin-2, ki spodbuja limfocite T k razmnoževanju.