natgillin/translations-raw huggingface dataset:
However, you will need to speak to your doctor or pharmacist about the best replacement if you need further treatment once your supply runs out.
Vendar se boste morali pogovoriti z zdravnikom ali farmacevtom o najboljšem nadomestilu, če potrebujete nadaljnje zdravljenje, ko bo vaše zaloge zmanjkalo.
Following a request from companies involved in the review, the PRAC re-examined and confirmed its previous recommendation in December 2017.
Na zahtevo družb, vključenih v pregled, je odbor opravil ponovni pregled in decembra 2017 potrdil svoje prejšnje priporočilo.
The dose of NAC may have to be increased and the optimal dosing has not been determined.
Morda je treba povečati odmerek NAC, vendar optimalno odmerjanje ni določeno.
Although this should be determined at local level in consultation with local Poison Information Centres, the following general guidance may be helpful unless local guidelines have already been adapted or already recommend a more conservative approach:
Čeprav je treba postopek določiti na lokalni ravni ob posvetovanju z lokalnimi centri za zastrupitve, so lahko koristna naslednja splošna navodila, razen če so lokalna navodila že prilagojena ali je v njih že priporočen bolj konservativen pristop:
They are available in Belgium, Denmark, Finland, Greece, Iceland, Luxembourg, the Netherlands, Portugal, Romania, and Sweden under various names including Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard and Pinex Retard.
Na voljo so v Belgiji, na Danskem, Finskem, v Grčiji, Islandiji, Luksemburgu, na Nizozemskem, Portugalskem, v Romuniji in na Švedskem pod različnimi imeni, med katere spadajo Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard in Pinex Retard.
The medicines will remain suspended unless the companies that hold the marketing authorisations can provide evidence of appropriate and practical EU-wide measures to help prevent overdose with these products and adequately reduce its risks.
Zdravila bodo začasno umaknjena, razen če družbe, ki imajo dovoljenje za promet, predložijo dokaze o ustreznih in praktičnih ukrepih na ravni EU za preprečevanje prevelikega odmerjanja s temi zdravili in ustrezno zmanjšanje njegovih tveganj.
Recommendation endorsed due to the difficulty in managing overdose
Priporočilo je potrjeno zaradi težav pri obravnavi prevelikega odmerjanja
− antidote should be dosed as recommended by the local Poison Information Centre.
− antidot moramo odmerjati v skladu s priporočili lokalnega centra za zastrupitve.
Paracetamol has been widely used for many years to relieve pain and fever in adults and children.
Paracetamol se že vrsto let uporablja za lajšanje bolečin in zniževanje zvišane telesne temperature pri odraslih in otrocih.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety of human medicines, which made recommendations in September 2017.
Pregled je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnosti zdravil za uporabo v humani medicini, in septembra 2017 podal priporočila.
• If you are taking modified-release medicines, you can continue to do so.
• Če jemljete zdravila s prirejenim sproščanjem, jih lahko še naprej.
Additional samples should be considered if serum paracetamol concentrations are not declining to low levels.
Razmislimo o odvzemu dodatnih vzorcev, če koncentracije paracetamola v serumu ne padejo na nizke ravni.
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position.
Priporočila odbora PRAC so bila poslana Skupini za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela stališče.
Modified-release medicines containing paracetamol with the opioid painkiller tramadol are available under the names Diliban Retard or Doreta SR in Bulgaria, Czech Republic, Estonia, Hungary, Iceland, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia and Spain, and these medicines are also covered by this review.
Zdravila s prirejenim sproščanjem proti bolečinam, ki vsebujejo paracetamol z opioidom tramadolom, so na voljo pod imenoma Diliban Retard ali Doreta SR v Bolgariji, na Češkem, v Estoniji, na Madžarskem, v Islandiji, Latviji, Litvi, na Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji in Španiji.
CMDh noted the PRAC conclusion that practical measures to sufficiently reduce the risk to patients had not been identified.
Skupina je upoštevala sklep odbora PRAC, da praktični ukrepi za zadostno zmanjšanje tveganja pri bolnikih niso bili ugotovljeni.
Patients can safely continue treatment in the approved indication and doses with any remaining supply.
Bolniki lahko varno nadaljujejo zdravljenje s preostalo zalogo za odobrene indikacije in z odobrenimi odmerki.
These combination products are also being removed.
Tudi ta kombinirana zdravila bodo umaknjena iz prometa.
15 December 2017 EMA/811872/2017
19. februar 2018 EMA/109109/2018
• Patients should continue using paracetamol medicines in line with instructions in the package leaflets, particularly instructions on how much to take.
• Bolniki morajo še naprej uporabljati zdravila s paracetamolom v skladu z navodili v navodilu za uporabo, zlasti navodili o odmerjanju zdravila.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
1 Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn in Norveško.
If serum paracetamol levels exceed the treatment nomogram at any time point, treatment with antidote (NAC) is indicated;
Če vrednosti paracetamola v serumu presegajo nomogram za zdravljenje ob katerem koli času, je indicirano zdravljenje z antidotom (NAC);
Paracetamol-containing immediate-release products have been authorised in all EU Member States but are not included in EMA's review.
Zdravila s takojšnjim sproščanjem, ki vsebujejo paracetamol, so odobrena v vseh državah članicah EU, vendar niso vključena v postopek pregleda pri agenciji.
A letter providing further information and advice in case of known or suspected overdoses with paracetamol modified-release containing products will be circulated to healthcare professionals who deal with paracetamol overdosage in the affected Member States.
Dopis z dodatnimi informacijami in nasveti v primeru znanih ali domnevnih prevelikih odmerkov z zdravili s prirejenim sproščanjem, ki vsebujejo paracetamol, bodo razdeljeni zdravstvenim delavcem, ki se ukvarjajo s prevelikim odmerjanjem paracetamola v zadevnih državah članicah.
Because the CMDh decision was agreed by majority vote it will now be sent to the European Commission which will issue a final legally binding decision valid throughout the EU.
Ker je skupina svoje stališče sprejela z večino glasov, so ga poslali Evropski komisiji, ki je izdala končni pravno zavezujoč sklep za vso EU.
− if NAC treatment has been initiated, it should be prolonged beyond the first 21-hour NAC course if paracetamol level remains above the limit of detection (or greater than 10 mg/L) or if ALT is increasing (greater than 100 U/L), and should be continued until paracetamol is below the limit of detection (or 10 mg/L) or if ALT is falling below 100 U/L;
− če začnemo zdravljenje z NAC, ga moramo podaljšati po prvi 21-urni shemi NAC, če raven paracetamola ostane nad mejo zaznavnosti (ali je višja od 10 mg/l) ali če vrednost ALT narašča (višja od 100 e./l), in ga moramo nadaljevati, dokler se raven paracetamola ne zniža pod mejo zaznavnosti (ali 10 mg/l) ali se vrednost ALT ne zniža pod 100 e./l;
• When used correctly and at the recommended doses, paracetamol is an effective and safe treatment for pain and fever.
• Ob pravilni uporabi in pri priporočenih odmerkih je paracetamol učinkovit in varen za zdravljenje bolečin in zvišane telesne temperature.
Furthermore, it had not proved possible to agree a feasible and standardised way to adapt the management of overdose across the EU to cover both immediate- and modified-release paracetamol products.
Poleg tega ni bilo možno soglasje o izvedljivem in standardiziranem načinu prilagajanja obravnave prevelikega odmerjanja po vsej EU, tako da bi zajemala zdravila s paracetamolom s takojšnjim in prirejenim sproščanjem.
• Until modified-release products have been removed from the market, adaptations of the standard protocol for paracetamol overdose should be considered.
• Dokler zdravila s prirejenim sproščanjem ne bodo umaknjena iz prometa, je treba razmisliti o prilagoditvah standardnega protokola za preveliko odmerjanje paracetamola.
Products covered by this review contain paracetamol for modified-release and are intended to be taken by mouth and have a longer action.
Zdravila, ki jih zajema ta pregled, vsebujejo paracetamol s prirejenim sproščanjem, so namenjena zaužitju skozi usta in imajo daljše delovanje.
The Agency's recommendations are based on a review of available data including a retrospective pharmacokinetic and clinical analysis of 53 cases of acute overdose with modified-release paracetamol by the Swedish Poison Information Centre,1 which found that the standard treatment protocol utilising solely the Rumack-Matthew nomogram (or variations thereof) based on conventional paracetamol formulations may not be effective for overdoses with modified-release paracetamol formulations.
Priporočila agencije temeljijo na pregledu razpoložljivih podatkov, vključno z retrospektivno farmakokinetično in klinično analizo 53 primerov akutnega prevelikega odmerjanja s paracetamolom s prirejenim sproščanjem, ki jo je pripravil Švedski informacijski center za zastrupitve,1 v kateri ugotavlja, da standardni protokol zdravljenja z izključno uporabo nomograma Rumack-Matthew (ali njegove različice) na podlagi običajnih formulacij paracetamola morda ni učinkovit pri prevelikih odmerkih s formulacijami paracetamola s prirejenim sproščanjem.
The usual protocols of sampling and treatment regimens used in the management of overdose with immediate-release formulations are therefore not adequate.
Običajni protokoli vzorčenja in zdravljenja, ki se uporabljajo pri zdravljenju prevelikega odmerjanja s formulacijami s takojšnjim sproščanjem, zato niso primerni.
• Some modified-release medicines are available in combination with another painkiller, tramadol.
• Nekatera zdravila s prirejenim sproščanjem so na voljo v kombinaciji z drugim zdravilom proti bolečinam, tramadolom.
Immediate-release paracetamol products, which are not affected by this review, will continue to be available as before.
Zdravila s paracetamolom s takojšnjim sproščanjem, na katere ta postopek pregleda ne vpliva, bodo še naprej na voljo kot doslej.
In many cases, it may not be known whether an overdose of paracetamol involves immediate-release or modifiedrelease products, making it difficult to decide how the overdose should be managed.
V mnogih primerih morda ni znano, ali je s prevelikim odmerjanjem paracetamola povezano zdravilo s takojšnjim sproščanjem ali prirejenim sproščanjem, zato je težko presoditi, kako obravnavati preveliko odmerjanje.
− if time since ingestion is unknown or serum paracetamol concentration cannot be obtained within 8 hours of the overdose, it is recommended that treatment with antidote (NAC) should be initiated without waiting for serum paracetamol concentrations to be available;
− če čas od zaužitja ni znan ali koncentracije paracetamola v serumu ni mogoče določiti v osmih urah po prevelikem odmerjanju, je priporočljivo, da zdravljenje z antidotom (NAC) začnemo brez čakanja na določitev serumske koncentracije paracetamola;
The CMDh1 has endorsed by majority a European Medicines Agency recommendation to suspend marketing of modified- or prolonged-release products containing paracetamol (designed to release paracetamol slowly over a longer period than the usual immediate-release products).
Dne 13. decembra 2017 je skupina CMDh1 z večino sprejela priporočilo Evropske agencije za zdravila za začasno prekinitev trženja zdravil s prirejenim ali podaljšanim sproščanjem, ki vsebujejo paracetamol (zasnovanih za počasno sproščanje paracetamola v daljšem časovnem obdobju kot pri običajnem zdravilu s takojšnjim sproščanjem).
• Paracetamol medicines designed to release the active ingredient over a long period (modifiedrelease medicines) are being taken off the market.
• Zdravila s paracetamolom, namenjena sproščanju zdravilne učinkovine v daljšem obdobju (zdravila s prirejenim sproščanjem), bodo umaknjena iz prometa.
− where <10 g of paracetamol has been ingested and time since ingestion is known, multiple serum paracetamol samples should be taken at suitable intervals (e.g. 4, 6, and 8 hours after ingestion).
− če je bolnik zaužil < 10 g paracetamola in je čas zaužitja znan, moramo določiti paracetamol v več vzorcih seruma v primernih časovnih presledkih (npr. štiri, šest in osem ur po zaužitju).
• The established treatment guidelines for paracetamol overdose are based on the immediaterelease products and may not be effective for treatment of overdoses with modified-release paracetamol.
• Uveljavljene smernice za zdravljenje prevelikega odmerjanja paracetamola temeljijo na zdravilih s takojšnjim sproščanjem in morda niso učinkovite za zdravljenje prevelikega odmerjanja paracetamola s prirejenim sproščanjem.
CMDh agreed with the Agency's advice that the advantages of a longer-acting product did not outweigh the complications of managing an overdose of the medicine, since the treatment procedures for immediate-release products are not appropriate for modified-release paracetamol.
Strinjala se je z nasvetom agencije, da prednosti zdravila z dolgotrajnim delovanjem ne odtehtajo zapletov pri obravnavi prevelikega odmerjanja zdravila, saj postopki zdravljenja za zdravila s takojšnjim sproščanjem niso primerni za paracetamol s prirejenim sproščanjem.
The CMDh therefore endorsed the PRAC recommendation that the marketing authorisations for medicines containing modified-release paracetamol, alone or combined with the opioid medicine tramadol, should be suspended.
Skupina CMDh je zato potrdila priporočilo odbora PRAC, da je treba začasno umakniti dovoljenja za promet z zdravili s prirejenim sproščanjem, ki vsebujejo samo paracetamol ali kombinacijo paracetamola in opioidnega zdravila tramadol.
− where overdose with ≥10 g of paracetamol (or ≥150 mg/kg body weight in children) is known or suspected, or where dose is unknown, treatment with antidote (N-acetylcysteine, NAC) should be started immediately regardless of the initial serum paracetamol level, since serum paracetamol level after acute overdose with modified-release products may peak up to 24 hours after ingestion;
− ob znanem prevelikem odmerjanju z ≥ 10 g paracetamola (ali ≥ 150 mg/kg telesne mase pri otrocih) ali sumu nanj ali če je odmerek neznan, moramo takoj začeti zdravljenje z antidotom (N-acetilcistein, NAC) ne glede na začetno raven paracetamola v serumu, ker lahko raven paracetamola v serumu po akutnem prevelikem odmerjanju zdravila s prirejenim sproščanjem doseže vrh do 24 ur po zaužitju;
• These modified-release medicines are being removed from the market because of the difficulty in managing overdoses.
• Zdravila s prirejenim sproščanjem bodo iz prometa umaknjena zaradi težav pri obravnavi prevelikega odmerjanja.
Modified-release paracetamol-containing products to be suspended from EU market
Zdravila s prirejenim sproščanjem, ki vsebujejo paracetamol, je treba začasno umakniti iz prometa v EU
• Modified-release paracetamol (alone or combined with tramadol) is being removed from the EU market since overdoses with modified-release paracetamol products can be unpredictable in their pharmacokinetics, and complex to manage.
• Paracetamol s prirejenim sproščanjem (sam ali v kombinaciji s tramadolom) bo umaknjen iz prometa v EU, ker ima preveliko odmerjanje zdravil s prirejenim sproščanjem, ki vsebujejo paracetamol, nepredvidljivo farmakokinetiko in zapleteno obravnavo.
The recommendation was made by the Agency's experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC).
Odbor za oceno tveganja na področju farmakovigilance (PRAC).
• There are no issues with modified-release paracetamol preparations when used in accordance with their product information.
• Pri uporabi pripravkov s paracetamolom s prirejenim sproščanjem v skladu z informacijami o zdravilu ni težav.
• Ordinary ‘immediate-release' paracetamol medicines are not affected by this review and will continue to be available as before.
• Ta postopek pregleda ne vpliva na običajna zdravila s paracetamolom za takojšnje sproščanje, ki bodo še naprej na voljo kot doslej.
• You should seek medical advice quickly if you have taken, or think you may have taken, more than the recommended amount of any paracetamol-containing product.
• Če ste vzeli, ali menite da ste vzeli, večji odmerek zdravila, ki vsebuje paracetamol, od priporočenega, se nemudoma posvetujte z zdravnikom.
Prescribers should discuss switching to an appropriate alternative if necessary once patients' supply runs out.
Ko bodo bolnikom zaloge pošle, naj se z zdravnikom, ki je zdravilo predpisal, posvetujejo o prehodu na ustrezno nadomestno zdravljenje.
Efficacy after 24 weeks of treatment
Učinkovitost po 24 tednih zdravljenja
The results were similar in study 3.
Rezultati so bili podobni v študiji 3.
Physician's overall assessment of treatment effectiveness:
Zdravnikova celotna ocena učinkovitosti zdravljenja:
300 300 450 525 600 DO NOT ADMINISTER- data is unavailable for dose recommendation
300 300 450 525 600 NE UPORABLJAJTE - podatki za priporočila za odmerjanje niso na voljo
Date of first authorisation: 25 October 2005 Date of latest renewal: 22 June 2015
Datum prve odobritve: 25. oktober 2005 Datum zadnjega podaljšanja: 22. junij 2015
You may see an air bubble, which is normal.
Morda lahko vidite majhen zračni mehurček, kar je normalno.
If necessary, the product may be returned to the refrigerator for later use, but this must not be done more than once.
Če je potrebno, je injekcijsko brizgo mogoče ponovno shraniti v hladilnik za kasnejšo uporabo, vendar tega ne smete storiti več kot enkrat.
Do not use if solid particles are present.
Ne uporabite ga, če so prisotni trdni delci.
Then talk to your doctor to discuss when you should inject the next dose.
Nato se pogovorite z zdravnikom in se posvetujte, kdaj si morate injicirati naslednji odmerek.
Note that in some cases it may take longer than 20 minutes for the powder to dissolve completely.
Upoštevajte, da utegne včasih trajati dalj kot 20 minut, da se bo prašek povsem raztopil.
Most of the reactions were mild or moderate in severity.
Reakcije so bile večinoma blage ali zmerne.
There are not enough data in this group.
V tej starostni skupini ni dovolj podatkov.
Training to recognise serious allergic reactions
Učenje prepoznavanja resnih alergijskih reakcij
15 months.
15 mesecev
Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue France
Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue Francija
Age, Race/Ethnicity, Gender, Body Mass Index
Starost, rasa/narodnost, spol, indeks telesne mase
Whole study 1 population Xolair N=209
Celotna populacija študije 1 Xolair N=209
• If you need to give more than one injection for the full dose, choose a different injection site each time you inject.
• Če morate za celotni odmerek dati več kot eno injekcijo, si za to vsakokrat izberite drugo mesto injiciranja.
Follow your doctor's instructions.
Upoštevajte navodila svojega zdravnika.
The lyophilised medicinal product takes 15-20 minutes to dissolve, although in some cases it may take longer.
Za raztopitev liofiliziranega zdravila je potrebno 15-20 minut, v nekaterih primerih pa lahko tudi več.
• Do not inject into areas where the skin is tender, bruised, red, or hard.
• Zdravila ne injicirajte v predele, kjer je koža bolj občutljiva, podpluta, rdeča ali trda.
1 vial and 1 ampoule.
1 viala in 1 ampula.
Your doctor will discuss with you the benefits and potential risks of being given this medicine during pregnancy.
Zdravnik se bo z vami pogovoril o koristih in možnih nevarnostih uporabe tega zdravila v nosečnosti.
Quality of life scores were measured using the Juniper Asthma-related Quality of Life Questionnaire.
Rezultate kvalitete življenja so vrednotili z uporabo vprašalnika “Juniper Asthma-related Quality of Life Questionnaire”.
p-value is derived from ANCOVA t-test.
Vrednost p je pridobljena z ANCOVA t-testom.
- It is important to be properly trained on how to inject the medicine before injecting yourself.
- Pomembno je, da ste ustrezno usposobljeni za injiciranje zdravila, preden si ga injicirate sami.
No effects on the breast-fed newborns/infants are anticipated.
Učinka na dojene novorojenčke/dojenčke ni pričakovati.
The chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours at 2°C to 8°C and for 4 hours at 30°C.
Kemijsko in fizikalno stabilnost rekonstituiranega zdravila so dokazali za 8 ur pri 2 °C do 8 °C in za 4 ure pri 30 °C.
Other items you need for your injection:
Dodatni pripomočki, ki jih potrebujete pri injiciranju:
Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
Odmerke je treba prilagajati pomembnim spremembam telesne mase (glejte preglednici 2 in 3).
The pathogenesis of SLE is not well understood.
Patogeneza SLE ni dobro pojasnjena.
Clinical trial experience of long-term treatment beyond 6 months in this indication is limited.
Kliničnih izkušenj z dolgotrajnim zdravljenjem več kot 6 mesecev za to indikacijo je malo.
From a microbiological point of view, the medicinal product should be used immediately after reconstitution.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
The shelf life includes potential temperature excursions.
Rok uporabnosti vključuje tudi morebitne temperaturne odklone.
Therefore treatment with this formulation is intended to be administered by a healthcare provider only.
Zato je pri zdravljenju s to formulacijo predvideno, da zdravilo aplicira samo zdravstveni delavec.
How much you will be given
Koliko zdravila boste prejeli
It belongs to a class of medicines called monoclonal antibodies.
Sodi v skupino zdravil, ki jih imenujemo monoklonska protitelesa.
Reactions reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
Učinkom, o katerih so poročali v obdobju trženja, je pripisana neznana navedba pogostnosti (ni mogoče oceniti iz razpoložljivih podatkov).
The dose for adolescents aged 12 years and above is the same as for adults.
Odmerki za mladostnike, ki so stari 12 let ali več, so enaki kot pri odraslih.
Important safety information
Pomembni varnostni podatki
Total injection volume (ml)
Celotni injicirani volumen (ml)
Medical treatment should be sought and instituted appropriately.
Poiskati je treba zdravniško pomoč in ustrezno ukrepati.
In addition, covariate effects were evaluated by analysing the relationship between omalizumab concentrations and clinical responses.
Poleg tega so ocenjevali tudi vpliv sospremenljivk z analiziranjem razmerja med koncentracijami omalizumaba in kliničnimi odzivi.
The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients.
Pogostnost infestacije s helminti je bila v celotnem kliničnem programu, ki ni bil zasnovan za odkrivanje takih infestacij, manj od 1 na 1.000 bolnikov.
This is intended to protect against accidental needlestick injuries.
To je namenjeno zaščiti pred poškodbami zaradi nehotenega vboda z iglo.
There are limited data available on the use of Xolair in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.
O uporabi zdravila Xolair pri bolnikih, starejših od 65 let, so na voljo omejeni podatki, ni pa dokazov, da bi bili pri starejših bolnikih potrebni drugačni odmerki kot pri mlajših odraslih bolnikih.