natgillin/translations-raw huggingface dataset:
A main study of 1,093 patients with advanced squamous non-small cell lung cancer showed that adding Portrazza to gemcitabine and cisplatin chemotherapy can lead to a modest improvement in survival.
Glavna študija s 1 093 bolniki z napredovalim skvamoznim nedrobnoceličnim pljučnim rakom je pokazala, da lahko dodajanje zdravila Portrazza pri kemoterapiji z gemcitabinom in cisplatinom prispeva k zmernemu izboljšanju preživetja.
In the main study, adding Portrazza to gemcitabine and cisplatin chemotherapy improved survival by a modest one and a half months without causing significant worsening in overall patient health.
V glavni študiji je dodajanje zdravila Portrazza pri kemoterapiji z gemcitabinom in cisplatinom izboljšalo preživetje za skromen mesec in pol brez povzročitve bistvenega poslabšanja splošnega zdravja bolnika.
For the first 6 cycles, Portrazza is given together with gemcitabine and cisplatin chemotherapy, after which it is given on its own for as long the disease remains stable and the patient can tolerate it.
Prvih šest ciklov se zdravilo Portrazza daje skupaj s kemoterapijo z gemcitabinom in cisplatinom, zatem se daje samostojno, dokler bolezen ostane stabilna in bolnik prenaša zdravilo.
Portrazza is a medicine for treating advanced stages of a type of lung cancer known as squamous nonsmall cell lung cancer.
Portrazza je zdravilo za zdravljenje napredovalih stopenj vrste pljučnega raka, imenovanega skvamozni nedrobnocelični pljučni rak.
Portrazza is available as a concentrate for making a solution and can only be obtained with a prescription.
Zdravilo Portrazza je na voljo kot koncentrat za pripravo raztopine in se izdaja le na recept.
For the full list of all side effects reported with Portrazza, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Portrazza, glejte navodilo za uporabo.
For practical information about using Portrazza, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Portrazza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For more information about treatment with Portrazza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Portrazza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Portrazza is only used in adults whose cancer cells have a specific protein (EGFR) on their surface and it is used together with gemcitabine and cisplatin chemotherapy.
Zdravilo Portrazza se uporablja samo pri odraslih, pri katerih imajo rakave celice na površini specifično beljakovino (EGFR), in sicer skupaj s kemoterapijo z gemcitabinom in cisplatinom.
There was no improved survival in patients with non-EGFR cancer cells.
Pri bolnikih z rakavimi celicami brez EGFR ni bilo izboljšanja preživetja.
How is Portrazza used?
Kako se zdravilo Portrazza uporablja?
Portrazza is given as a one hour infusion (drip) into a vein.
Zdravilo Portrazza se daje kot enourna infuzija (kapalna infuzija) v veno.
The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to EGFR on the surface of the cancer cells.
Zdravilna učinkovina zdravila Portrazza, necitumumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino EGFR na površini rakavih celic in se veže nanjo.
How does Portrazza work?
Kako zdravilo Portrazza deluje?
Portrazza contains the active substance necitumumab.
Zdravilo Portrazza vsebuje zdravilno učinkovino necitumumab.
Dissolution was evaluated over an 8-hour period.
Raztapljanje so preučevali v 8-urnem obdobju.
Overall summary of the scientific evaluation of Ethirfin and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Ethirfin in povezanih imen (glejte Dodatek I)
About 20% of the responders reported chronic pain (>6 months).
Okoli 20 odstotkov odzivnih bolnikov je poročalo o kronični bolečini (> 6 mesecev).
The application was submitted to the reference Member State Denmark and to the concerned Member States (CMS) Germany, Ireland, Italy and the United Kingdom.
Vloga je bila predložena referenčni državi članici Danski in zadevnim državam članicam Nemčiji, Irski, Italiji in Združenemu kraljestvu.
Source; Brennan et al., Addiction 2005; 100 : 777-86
Vir; Brennan et al. Addiction 2005; 100:777-86
• The Committee is also of the opinion that further risk minimisation measures would not adequately address the concern,
• Odbor tudi meni, da nadaljnji ukrepi za zmanjševanje tveganja ne bi ustrezno obravnavali zadeve,
This may be further aggravated by the fact that many patients with chronic pain will also suffer from depression.
To lahko nadalje poslabša dejstvo, da se pri velikem številu bolnikov s kronično bolečino pojavlja tudi depresija.
This strength is considered representative for the other (20, 60 and 120 mg) strengths as all strengths are dose proportional and manufactured with the same microgranules.
Ta jakost je reprezentativna za druge jakosti (20, 60 in 120 mg), saj so vse jakosti sorazmerne z odmerkom in se proizvedejo z istimi mikro zrnci.
Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
Sočasna depresija in bolečina imata bistveno večji vpliv kot vsaka motnja posebej, pri bolnikih z bolečino je depresija povezana z več mesti bolečine, večjo intenzivnostjo bolečine, daljšim trajanjem bolečine in večjo verjetnostjo, da bo odziv na zdravljenje slab (Bair, J. et al., Psychosom Med. 2008 oktober; 70(8): 890-897).
However, a significant percentage of the patients with chronic pain who uses opioids still reports high alcohol intake (10.8%) and binge drinking at least once a month (22.3%), despite existing warnings.
Vendar pa velik delež bolnikov s kronično bolečino, ki jemljejo opioide, še vedno poroča o visokem vnosu alkohola (10,8 odstotka) in popivanju najmanj enkrat mesečno (22,3 odstotka) kljub obstoječim opozorilom.
It was shown that the dissolution rate increases with increased concentration of ethanol in the dissolution medium.
Ugotovitve kažejo, da se stopnja raztapljanja povečuje s povečanjem koncentracije etanola v mediju za raztapljanje.
Whereas
ORa
The CHMP considered the matter and adopted an Opinion in July 2010 recommending the renewal of the marketing authorisation subject to conditions considered essential to the safe and effective use of the product.
CHMP je preučil zadevo in julija 2010 sprejel mnenje, v katerem je priporočil podaljšanje dovoljenje za promet z zdravilom v skladu s pogoji, ki so bistveni za varno in učinkovito uporabo zdravila.
While it may be argued that patients may use less alcohol as a self-medication strategy if they are sufficiently treated with analgesics like opioids, the results of a recently published Danish Health survey (Ekholm et al. Eur J Pain 2009; 13: 606-12) reveal a different pattern of behavior.
Čeprav nekateri morda zagovarjajo stališče, da bi bolniki zaužili manj alkohola kot sredstva za samozdravljenje, če bi bili ustrezno zdravljeni z analgetiki, kot so opioidi, so rezultati nedavno objavljene danske zdravstvene raziskave (Ekholm et al. Eur J Pain 2009; 13:606-12) pokazali drugačen vzorec vedenja.
In the scientific literature, drinking alcohol is referred as a coping mechanism to deal with the stress associated with pain.
V znanstveni literaturi je uživanje alkohola znano kot mehanizem za obvladovanje stresa, povezanega z bolečino.
Out of specification results were obtained after 0.25 hours in 20% alcohol, after 0.5 hour in 10% alcohol and after 2 hours in 5% alcohol.
Rezultati zunaj specifikacijskih meja so bili pridobljeni po 0,25 ure pri 20-odstotnem alkoholu, po 0,5 ure pri 10-odstotnem alkoholu in po 2 urah pri 5-odstotnem alkoholu.
Dissolution profiles have been performed using the 200 mg capsule strength only.
Profili raztapljanja so bili preučevani samo z uporabo kapsul jakosti 200 mg.
It is noted that the product already contains a specific contraindication for concomitant intake of alcohol.
Znano je, da zdravilo že vključuje specifično kontraindikacijo za sočasno uživanje alkohola.
Ethypharm submitted an application for the renewal, under the mutual recognition procedure, of Ethirfin and associated names, 20mg, 60 mg, 120 mg and 200 mg.
Družba Ethypharm je v okviru postopka z medsebojnim priznavanjem predložila vlogo za podaljšanje dovoljenja za promet z zdravilom Ethirfin in povezanimi imeni, 20 mg, 60 mg, 120 mg in 200 mg.
At the end of the CMD(h) procedure, and since there could be no agreement the procedure was referred to the CHMP.
Ker do zaključka postopka CMD(h) ni prišlo do soglasja, je bila zadeva napotena na CHMP.
Modified-release products are complex dosage forms designed to release drugs in a controlled manner to achieve desired efficacy and safety profiles.
Zdravila s spremenjenim sproščanjem so kompleksne oblike odmerjanja, ki so namenjene nadzorovanemu sproščanju zdravil, da sta doseženi želena učinkovitost in varnost.
In this study, subjects were interviewed about their number of alcohol consumptions of the last week and frequency of binge drinking in the last month (5292 responders).
V tej študiji so preiskovance spraševali o številu zaužitih enot alkohola v preteklem tednu in pogostosti popivanja v preteklem mesecu (5292 odzivnih bolnikov).
The amount of pain at baseline was a significant predictive factor for alcohol use in the 3-years follow-up period.
Bolečina v izhodišču je bila pomemben napovedni dejavnik uporabe alkohola v triletnem obdobju spremljanja.
Germany and the United Kingdom raised potential serious risk to public health concerns due to the dissolution profile of the modified-release product allowing the release of up to 80% of the active substance within 30 minutes, when exposed to 20% alcohol.
Državi Nemčija in Združeno kraljestvo sta izpostavili morebitna resna tveganja za javno zdravje zaradi profila raztapljanja zdravila s spremenjenim sproščanjem, ki omogoča sproščanje do 80 odstotkov zdravilne učinkovine v 30 minutah, kadar je zdravilo izpostavljeno 20-odstotnemu alkoholu.
The polymethacrylate is a polymer that forms a continuous film when processed.
Polimetakrilat je polimer, ki po postopku obdelave tvori trajni film.
The association between pain and drinking was evaluated by Brennan et al in a cohort of 401 elderly with different drinking behavior (Brennan, Addiction.
Povezavo med bolečino in uživanjem alkohola so ocenjevali Brennan et al v skupini 401 starostnika z različnimi vzorci uživanja alkohola (Brennan, Addiction.
The triethylcitrate acts as a plasticizer.
Trietilcitrat deluje kot plastifikator.
However, alcohol use is common in patients with chronic pain due to the fact that it reduces pain perception.
Vendar je uporaba alkohola pri bolnikih s kronično bolečino pogosta, saj zmanjšuje zaznavanje bolečine.
• The Committee considered all the data submitted by the MAH,
• Odbor je preučil vse podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom,
Patients being treated with opioids tend to drink less alcohol than patients who do not use opioids at all.
Bolniki, ki se zdravijo z opioidi, navadno uživajo manj alkohola kot bolniki, ki opioidov sploh ne jemljejo.
The prolonged release properties of this product are ensured by the film coating composed of the polymethacrylate derivative plasticized by triethylcitrate (TEC) to which talc and hydrophobic colloidal silica are added.
Podaljšano sproščanje tega zdravila se zagotovi s filmsko oblogo, ki je sestavljena iz derivata polimetakrilata, plastificiranega s trietilcitratom (TEC), kateremu sta dodana smukec in hidrofobni koloidni silicijev dioksid.
• The Committee considered the procedure under Article 29(4) of Directive 2001/83/EC, as amended for Ethirfin and associated names,
• Odbor je upošteval postopek iz člena 29(4) Direktive 2001/83/ES, kakor je bila spremenjena, za zdravilo Ethirfin in povezana imena,
This effect is known as ‘dose-dumping'.
Ta učinek se imenuje „prekomerno sproščanje“.
Both problem drinkers as non-problem drinkers reported to use alcohol to manage pain, although in the latter group to less extent (see figure 1).
Tako problematični kot neproblematični pivci so poročali o uporabi alkohola za obvladovanje bolečine, čeprav je bil ta pojav v drugi skupini prisoten v manjši meri (gl. sliko 1).
If, however, the modified-release system is influenced by an external factor or substance (such as alcohol), it is possible that a large quantity of the active substance is released in a short timeframe so that it resembles an immediate-release dosage form.
Če na sistem s spremenjenim sproščanjem vpliva zunanji dejavnik ali snov (na primer alkohol), je mogoče, da se velik delež zdravilne učinkovine sprosti v kratkem časovnem obdobju, podobno kot pri obliki odmerjanja s takojšnjim sproščanjem.
No in vivo studies have been performed to investigate the effect of alcohol on the absorption of the product.
Študije in vivo za preučitev učinka alkohola na absorpcijo zdravila niso bile opravljene.
Benefit-Risk assessment
Ocena koristi in tveganj
During the assessment, major issues on safety were raised by Germany and the United Kingdom, hence the procedure was referred to CMD(h), under Article 29, paragraph 1 of Directive 2001/83/EC, as amended.
Med oceno sta glavne zadržke glede varnosti izrazili državi Nemčija in Združeno kraljestvo, zato je bil postopek napoten na CMD(h) v skladu s členom 29, odstavkom 1 Direktive 2001/83/ES, kakor je bila spremenjena.
The dissolution test method used was the routine test, i.e. paddle apparatus at 100 rpm with 1000 ml of medium.
Uporabljena metoda preskusa raztapljanja je bil rutinski preskus, in sicer je bil uporabljen aparat z lopaticami pri hitrosti 100 vrt/min s 1000 ml medija.
The association between chronic pain and alcohol use is summarized in the table below.
Povezava med kronično bolečino in uporabo alkohola je prikazana v spodnji preglednici.
This film acts as a membrane allowing the diffusion of the active substance depending on its permeability.
Ta film deluje kot membrana in omogoča razširjanje zdravilne učinkovine v skladu s svojo prepustnostjo.
The dissolution medium was water, loaded with 5, 10 and 20% ethanol in line with the EMA QWP Q&A document Need for in vitro Dissolution Studies with Alcohol for Modified Release Oral Products Including Opioid Drug Products.
Medij za raztapljanje je bila voda s 5-, 10- in 20-odstotnim etanolom, kot določa dokument z vprašanji in odgovori EMA QWP „Potreba po študijah raztapljanja in vitro z alkoholom pri zdravilih za peroralno uporabo s spremenjenim sproščanjem, vključno z opioidnimi zdravili“.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR NON-RENEWAL OF THE MARKETING AUTHORISATION
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA NEPODALJŠANJE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Following a request from the European Commission, in September 2010 the CHMP further considered, in light of the benefit-risk balance and the requirements of article 24(2) of Directive 2001/83/EC as amended, the recommendation previously adopted for the product.
Na zahtevo Evropske komisije je CHMP septembra 2010 ob upoštevanju razmerja med koristmi in tveganji ter določb člena 24(2) Direktive 2001/83/ES, kakor je bila spremenjena, nadalje obravnaval priporočilo, ki je bilo predhodno sprejeto za to zdravilo.
Grounds for non-renewal of the marketing authorisation
Podlaga za nepodaljšanje dovoljenja za promet z zdravilom
ANNEX II
Table 2
No adverse events have been reported for Ethirfin and associated names suspect to be related to the concomitant use of alcohol.
Pri zdravilu Ethirfin in povezanih imenih niso poročali o neželenih učinkih pri sočasni uporabi alkohola.
• The Committee therefore considered that patients exposed to the above mentioned products and concomitant intake of alcohol are at significantly greater risk of developing serious adverse reactions such as respiratory depression and death, and took the view that the risk-benefit balance of the product is not positive under normal conditions of use.
• Odbor je zato menil, da so bolniki ob sočasnem uživanju alkohola in jemanju zgoraj navedenih zdravil izpostavljeni bistveno večjemu tveganju pojava resnih neželenih reakcij, kot sta depresija dihanja in smrt, in zaključil, da pri normalnih pogojih uporabe razmerje med koristmi in tveganji za zdravilo ni pozitivno.
• In addition, the dissolution profile of Ethirfin is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, and therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
• poleg tega na profil raztapljanja zdravila Ethirfin bistveno vpliva prisotnost alkohola, ki povzroči nenadzorovano hitro sprostitev večine zdravilne učinkovine, zato je za zdravilo značilna močna interakcija z alkoholom s potencialno pomembnimi kliničnimi učinki (npr. depresija dihanja in smrt),
The polymethacrylate preparation is miscible in water and in ethanol.
Polimetakrilatni pripravek se meša z vodo in etanolom.
Both problem drinkers and non-problem drinkers were included.
V študiji so bili vključeni problematični in neproblematični pivci.
• 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, and that therefore the existing risk minimisation measures do not adequately address the concern,
• na podlagi objavljene literature velik delež populacije bolnikov, ki uporabljajo ta zdravila, ne preneha z uživanjem alkohola kljub obstoječim opozorilom in kontraindikacijam, in da zato obstoječi ukrepi za zmanjševanje tveganja zadeve ne obravnavajo v zadostni meri,
• The Committee considered that the dissolution profile of Ethirfin and associated names is significantly affected in the presence of alcohol, leading to an uncontrolled rapid release of the majority of the active substance, therefore the product exhibits a significant interaction with alcohol with potentially significant clinical effects (e.g. respiratory depression and death),
• Odbor je menil, da na profil raztapljanja zdravila Ethirfin in povezanih imen bistveno vpliva prisotnost alkohola, ki povzroči nenadzorovano hitro sprostitev večine zdravilne učinkovine, zato je za zdravilo značilna močna interakcija z alkoholom s potencialno pomembnimi kliničnimi učinki (npr. depresija dihanja in smrt),
Having considered the overall submitted data provided by the MAH, the CHMP concluded that
CHMP je ob upoštevanju vseh podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, zaključil:
The CHMP therefore recommended the non-renewal of the marketing authorisation in line with article 24(2) of Directive 2001/83/EC as amended.
CHMP je zato priporočil nepodaljšanje dovoljenja za promet v skladu s členom 24(2) Direktive 2001/83/ES, kakor je bila spremenjena.
• 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 zaključil, da velik delež populacije bolnikov, ki uporabljajo ta zdravila, ne preneha z uživanjem alkohola kljub obstoječim opozorilom in kontraindikacijam ter da zato obstoječi ukrepi za zmanjševanje tveganja zadeve ne obravnavajo v zadostni meri,
• A pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
• ne glede na formulacijo se lahko pojavi farmakodinamična interakcija med opioidnimi zdravili in alkoholom,
• The Committee noted that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
• Odbor je ugotovil, da se lahko ne glede na formulacijo pojavi farmakodinamična interakcija med opioidnimi zdravili in alkoholom,
Notification of a referral for arbitration, under Article 29(4) of Directive 2001/83/EC as amended, to the CHMP was made by Denmark on 30 October 2009.
Danska je dne 30. oktobra 2009 v skladu s členom 29(4) Direktive 2001/83/ES, kakor je bila spremenjena, obvestila CHMP o uradni napotitvi na arbitražo.
Triethylcitrate is water-soluble and miscible in ethanol.
Trietilcitrat je topen v vodi in se meša z etanolom.
for conventional-release products (NLT 75% dissolved active substance within 45 minutes) and therefore experiences severe alteration, leading to an uncontrolled rapid release of the majority of the active substance.
Rezultati preskusov raztapljanja kažejo, da je formulacija v okviru omejitev Evropske farmakopeje za zdravila s konvencionalnim sproščanjem (ne manj kot 75 odstotkov raztopljene zdravilne učinkovine v 45 minutah), zato so prisotne precejšnje spremembe, ki vodijo do nenadzorovane hitre sprostitve večine zdravilne učinkovine.
The repeated dose vaccination often gave slightly better results than the single vaccination.
Cepljenje s ponovljenim odmerkom je pogosto dalo nekoliko boljše rezultate kot enkratno cepljenje.
In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi živali virusu ali bakteriji v prihodnosti se bo imunski sistem tako hitreje odzval.
Further information on Porcilis PCV M Hyo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Porcilis PCV M Hyo so na voljo na spletni strani agencije:ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given.
Nenamerno injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst na roki - brez takojšnje zdravniške oskrbe lahko pride do izgube prsta.
In three of the studies there was a third similar-sized group of pigs that were vaccinated using the two-dose schedule.
Tri študije so vključevale podobno veliko skupino prašičev, ki so bili cepljeni po shemi z dvema odmerkoma.
The European Medicines Agency decided that Porcilis PCV M Hyo's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je odločila, da so koristi zdravila Porcilis PCV M Hyo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
The vaccine contains small amounts of a protein from PCV2 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease.
Cepivo vsebuje majhne količine beljakovine iz virusa PCV2 in cele bakterije Mycoplasma hyopneumoniae, ki so bile uničene (inaktivirane), tako da ne povzročajo bolezni.
For more information about using Porcilis PCV M Hyo, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Porcilis PCV M Hyo glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.