natgillin/translations-raw huggingface dataset:
• The PRAC recommended further changes to the product information such as warnings and precautions and updated information on the risks related to exposure during pregnancy to better inform the healthcare professionals and women.
• odbor PRAC je priporočil dodatne spremembe informacij o zdravilu, kot so opozorila in previdnostni ukrepi ter posodobljene informacije o tveganjih, povezanih z izpostavljenostjo v nosečnosti, da bodo zdravstveni delavci in ženske z njimi bolje seznanjeni.
In addition, the PRAC recommended education materials to be put in place in order to ensure that healthcare professionals and patients are informed about the risks associated with valproate in pregnant women and women of childbearing potential and on the measures necessary to minimise the risk.
Poleg tega je odbor PRAC priporočil, da se pripravi izobraževalno gradivo, ki bo zagotovilo, da bodo zdravstveni delavci in bolniki seznanjeni s tveganji, povezanimi z uporabo valproata pri nosečnicah in ženskah v rodni dobi, ter z ukrepi, potrebnimi za zmanjšanje tveganja.
The PRAC also imposed a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Poleg tega je odbor PRAC zahteval, da se izvede študija o uporabi zdravila, namenjena oceni učinkovitosti ukrepov za zmanjšanje tveganja in podrobnejši opredelitvi vzorcev predpisovanja valproata.
Available data show an increased incidence of minor and major malformations in children born to mothers treated with valproate and related substances during pregnancy.
Razpoložljivi podatki kažejo večjo incidenco manjših in večjih malformacij pri otrocih, rojenih materam, ki so se v nosečnosti zdravile z valproatom in sorodnimi učinkovinami.
In view of the risks of valproate use during pregnancy and the available therapeutic alternatives for the treatment of acute migraine attacks, the PRAC concluded that in prophylaxis of migraine attacks valproate should be contraindicated in pregnancy or in women of childbearing potential who are not using effective methods of contraception.
Ob upoštevanju tveganj, povezanih z uporabo valproata v nosečnosti, in razpoložljivih drugih možnosti zdravljenja akutnih migrenskih napadov je odbor PRAC zaključil, da je treba uporabo valproata za profilakso migrenskih napadov kontraindicirati v nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo učinkovitih kontracepcijskih metod.
The Committee, as a consequence, concluded that the benefit-risk balance of valproate and related substances-containing medicinal products, remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information, where applicable, and other risk minimisation measures recommended.
Odbor je posledično zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo valproat in sorodne učinkovine, še naprej ugodno pod pogojem, da se upoštevajo pogoji dovoljenj za promet z zdravilom ter spremembe informacij o zdravilu, kadar je to primerno, in drugi priporočeni ukrepi za zmanjšanje tveganja.
The PRAC noted that valproate is considered to be an effective drug in the treatment of epilepsy and of manic episode in bipolar disorder, serious conditions that might be life threatening if not adequately controlled.
Odbor PRAC je upošteval, da naj bi bil valproat učinkovito zdravilo za zdravljenje epilepsije in manične epizode pri bipolarni motnji, pri čemer gre za resni stanji, ki sta lahko življenjsko nevarni, če nista ustrezno obvladani.
The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Tveganje je odvisno od odmerka, vendar mejne velikosti odmerka, pod katero tveganje ni prisotno, ni mogoče določiti.
• The PRAC considered that intra-uterine exposure to valproate and related substances is associated with an increased risk of developmental disorders in the offspring.
• odbor PRAC je menil, da je izpostavljenost valproatu in sorodnim učinkovinam v maternici povezana s povečanim tveganjem za razvojne motnje pri potomcih.
The PRAC noted the concerns raised from patients about a lack of awareness on the risks associated with valproate in utero exposure.
Odbor PRAC je upošteval zaskrbljenost, ki so jo bolniki izrazili nad nezadostnim poznavanjem tveganj, povezanih z izpostavljenostjo valproatu in utero.
In this respect, the PRAC recommended amendments to the product information, including strengthening of the wording to reflect the current knowledge of risks of developmental disorders and congenital anomalies and communication to healthcare professionals through a direct healthcare professional communication.
Ob upoštevanju navedenega je odbor PRAC priporočil spremembe informacij o zdravilu, ki vključujejo razširitev besedila, da se vključi vse, kar je trenutno znanega o tveganjih za razvojne motnje in prirojene anomalije, ter obveščanje zdravstvenih delavcev z neposrednim obvestilom za zdravstvene delavce.
• The PRAC considered the totality of the data submitted with regard to safety and efficacy in female children, women of childbearing potential and pregnant women treated with valproate and related substances.
• odbor PRAC je proučil vse predložene podatke v zvezi z varnostjo in učinkovitostjo pri otrocih ženskega spola, ženskah v rodni dobi in nosečnicah, zdravljenih z valproatom in sorodnimi učinkovinami.
Based on clinical data and also the views of the relevant experts it was concluded valproate should remain an option for female patients, but should be reserved for situations when other treatment alternatives have been tried and failed.
Na podlagi kliničnih podatkov in mnenj zadevnih strokovnjakov je bilo zaključeno, da mora valproat ostati možnost zdravljenja za bolnice, vendar se lahko uporablja samo v primerih, ko so bile že preskušene druge vrste zdravljenja, a niso bile uspešne.
These include a prescriber guide, patient booklet and information ensuring the understanding and the awareness of prescribers and patients on the risks.
Gradivo vključuje navodila za predpisovanje, brošuro za bolnike in informacije, s katerimi se bo zagotovilo, da bodo zdravniki in bolniki poznali in razumeli tveganja.
Therefore, the PRAC recommends the variation to the terms of the marketing authorisation for the valproate and related substances containing medicinal products referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Odbor PRAC je zato priporočil spremembo pogojev dovoljenja za promet z zdravilom za zdravila, ki vsebujejo valproat in sorodne učinkovine ter so navedena v Prilogi I, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III k priporočilu odbora PRAC.
• The PRAC concluded that valproate and related substances should be contraindicated in prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate.
• odbor PRAC je zaključil, da je treba valproat in sorodne učinkovine kontraindicirati pri profilaksi migrenskih napadov v nosečnosti in pri ženskah v rodni dobi, ki med zdravljenjem z valproatom ne uporabljajo učinkovitih kontracepcijskih metod;
Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Znanstveni zaključki in podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC
Therefore, the PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women for the treatment of epilepsy and manic episode in bipolar disorder unless alternatives treatments are ineffective or not tolerated.
Odbor PRAC je zato zaključil, da se valproat in sorodne učinkovine ne smejo uporabljati pri otrocih ženskega spola, ženskah v rodni dobi in nosečnicah za zdravljenje epilepsije in manične epizode pri bipolarni motnji, razen kadar so druge vrste zdravljenja neučinkovite ali pa jih bolnice ne prenašajo.
In addition, the PRAC considered the views of patients, families and carers, and the views of healthcare professionals for the understanding and the awareness of the risks associated with valproate in utero exposure.
Poleg tega je odbor PRAC proučil mnenja bolnikov, družin in negovalcev ter mnenja zdravstvenih delavcev o poznavanju in razumevanju tveganj, povezanih z izpostavljenostjo valproatu in utero;
Core elements of a direct healthcare professional communication (DHPC) were agreed, together with the timelines for its distribution.
Opredeljeni so bili bistveni deli neposrednega obvestila zdravstvenim delavcem in roki za njegovo razdelitev.
Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom pod določenimi pogoji ter podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC
2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC
• The PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated in the following indications:
• odbor PRAC je zaključil, da se valproat in sorodne učinkovine ne smejo uporabljati pri otrocih ženskega spola, ženskah v rodni dobi in nosečnicah, razen kadar so druge vrste zdravljenja neučinkovite ali pa jih bolnice ne prenašajo, za naslednje indikacije:
In addition, the views of patients, families and carers, and the view of healthcare professionals regarding the implications, the understanding and awareness of the risks associated with valproate in utero exposure were taken into account in the recommendation.
Poleg tega je pri pripravi priporočila upošteval tudi mnenja bolnikov, družin in negovalcev ter mnenje zdravstvenih delavcev o posledicah, poznavanju in razumevanju tveganj, povezanih z izpostavljenostjo valproatu in utero.
The European Commission issued a decision on 30 March 2010.
Evropska komisija je odločbo izdala dne 30. marca 2010.
Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi morebitnega resnega tveganja za javno zdravje
Dr Harald Enzmann (Germany)
dr. Harald Enzmann (Nemčija)
Dr Robert James Hemmings (United Kingdom)
dr. Robert James Hemmings (Združeno kraljestvo)
The review was carried out under an ‘Article 29' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom1 po členu 29.
20 August 2009
20. avgust 2009
Ref. EMEA/CHMP/734816/2009 rev. EMEA/H/A-29/1216
: EMEA/CHMP/734816/2009 rev. EMEA/H/A-29/1216
London, 30 March 2010 Doc.
London, 30. marca 2010 Sklic dok.
Company responses provided on: 21 September 2009, 26 October 2009 Opinion date:
Odgovori družbe predloženi dne: 21. septembra 2009, 26. oktobra 2009 Datum izdaje mnenja:
Bioequivalence studies are used to compare how a generic medicine is absorbed by the body in comparison to the reference medicine.
Študije biološke enakovrednosti se uporabljajo za primerjavo načina, kako telo absorbira generično zdravilo v primerjavi z referenčnim zdravilom.
These are tablets that pass through the stomach without being broken down until they reach the intestine.
Te tablete preidejo skozi želodec nedotaknjene in se razgradijo šele, ko dosežejo črevesje.
Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Pantoprazole Bluefish pantoprazol 20 in 40 mg tablete
The grounds for the referral were concerns expressed by the Dutch, German, Irish and Italian medicines regulatory agencies regarding the bioequivalence study comparing Pantoprazole Bluefish and Pantecta.
Razlogi za napotitev so bili zadržki, ki so jih izrazili nizozemski, nemški, irski in italijanski regulativni organi za zdravila glede študije biološke enakovrednosti, v kateri so primerjali zdravili Pantoprazole Bluefish in Pantecta.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Pantoprazole Bluefish had been shown to be bioequivalent to the reference medicine, and therefore the marketing authorisation should be granted in Sweden and all concerned member states.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je ta zaključil, da se je zdravilo Pantoprazole Bluefish izkazalo za biološko enakovredno referenčnemu zdravilu, zato se lahko odobri dovoljenje za promet z zdravilom na Švedskem in v vseh zadevnih državah članicah.
However, the member states were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 July 2009.
Ker pa omenjene države članice niso dosegle soglasja, je švedski regulatorni organ dne 30. julija 2009 zadevo napotil na CHMP v arbitražo.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Bluefish.
Evropska agencija za zdravila (EMEA) je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Pantoprazole Bluefish.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Bluefish outweigh its risks, and the marketing authorisation can be granted in Sweden and in the following Member States of the European Union, Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, Spain as well as in Norway.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da koristi zdravila Pantoprazole Bluefish odtehtajo z njim povezana tveganja in da se dovoljenje za promet z zdravilom lahko odobri na Švedskem in naslednjih državah članicah Evropske unije: Avstriji, na Danskem, v Nemčiji, na Finskem, v Franciji, na Madžarskem, Irskem, v Italiji, na Nizozemskem, Poljskem, Portugalskem, v Španiji kot tudi na Norveškem.
The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
20-miligramske tablete se lahko uporabljajo za lajšanje simptomov refluksa, kot sta zgaga in regurgitacija kisline (vračanje kisline v usta), za dolgoročno zdravljenje in preprečevanje ponovne pojavitve refluksnega ezofagitisa (vnetje požiralnika zaradi kisline), za preprečevanje razjed na želodcu, ki jih lahko povzročajo nekatera zdravila za lajšanje bolečin in vnetij, imenovana neselektivna nesteroidna protivnetna zdravila (NSAID), kadar bolnik potrebuje stalno zdravljenje z NSAID.
Pantoprazole Bluefish is a medicine used to treat diseases where the stomach produces too much acid.
Pantoprazole Bluefish je zdravilo, ki se uporablja za zdravljenje bolezni, pri katerih želodec tvori preveč kisline.
Bluefish Pharmaceuticals AB submitted Pantoprazole Bluefish to the Swedish medicines regulatory agency for a decentralised procedure.
Družba Bluefish Pharmaceuticals AB je zdravilo Pantoprazole Bluefish predložila švedskemu regulatornemu organu za zdravila v presojo po decentraliziranem postopku.
Why was Pantoprazole Bluefish reviewed?
Zakaj je bilo zdravilo Pantoprazole Bluefish pregledano?
The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
40-miligramske tablete se lahko uporabljajo za zdravljenje hujših obolenj zaradi kisline, kot so razjede na želodcu in dvanajstniku, Zollinger-Ellisonovega sindroma (stanja, ki nastane zaradi čezmernega izločanja kisline v želodcu) in za pomoč pri odstranitvi bakterije Helicobacter pylori iz želodca, za katero je znano, da povzroča razjedo na želodcu.
This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal and Spain).
tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Avstriji, na Danskem, v Nemčiji,na Finskem, v Franciji, na Madžarskem, Irskem, v Italiji, na Nizozemskem, Norveškem, Poljskem, Portugalskem in v Španiji).
Pantoprozole Bluefish is a generic medicine based on the reference medicine Pantecta.
Pantoprozole Bluefish je generično zdravilo na osnovi referenčnega zdravila Pantecta.
What is Pantoprazole Bluefish?
Kaj je zdravilo Pantoprazole Bluefish?
It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Deluje tako, da zavira „protonske črpalke“, beljakovine v specializiranih celicah v želodčni sluznici, ki črpajo kislino v želodec Z zaviranjem črpalk pantoprazol zmanjša tvorbo kisline.
The active substance in Pantoprazole Bluefish, pantoprazole, is a proton pump inhibitor.
Zdravilna učinkovina zdravila Pantoprazole Bluefish, pantoprazol, je zaviralec protonske črpalke.
Pantoprazole Bluefish is presented as gastro-resistant tablets.
Zdravilo Pantoprazole Bluefish je na voljo v obliki gastrorezistentnih tablet.
This overview was last updated in 04-2018.
Pregled je bil nazadnje posodobljen 04-2018.
Further information on Bosulif can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Več informacij o zdravilu Bosulif je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bosulif is available as tablets (100, 400 and 500 mg).
Zdravilo Bosulif je na voljo v obliki tablet (100, 400 in 500 mg).
The recommended dose is 400 mg once a day for newly diagnosed patients, and 500 mg once a day for patients who have already been treated with other medicines.
Priporočeni odmerek je 400 mg enkrat na dan pri novo diagnosticiranih bolnikih in 500 mg enkrat na dan pri bolnikih, ki so se že zdravili z drugimi zdravili.
The European Medicines Agency therefore decided that the benefits of Bosulif are greater than in its risks and recommended that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Bosulif večje od z njim povezanih tveganj, in priporočila, da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Bosulif?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bosulif?
The doctor may increase the dose up to 600 mg once a day or reduce it or interrupt treatment according to how the medicine is working and the side effects the patient has.
Zdravnik lahko poveča odmerek na 600 mg enkrat na dan, ga zmanjša ali zdravljenje prekine, odvisno od tega, kako zdravilo deluje in kakšne neželene učinke ima bolnik.
Bosulif received a marketing authorisation valid throughout the EU on 27 March 2013.
Za zdravilo Bosulif je bilo 27. marca 2013 izdano dovoljenje za promet, veljavno po vsej EU.
Every year, the Agency will review any new information that becomes available and this summary will be updated as necessary.
Agencija bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
As for all medicines, data on the use of Bosulif are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bosulif stalno spremljajo.
Bosulif was not compared with another treatment.
Zdravila Bosulif niso primerjali z nobenim drugim zdravljenjem.
The side effects of the medicine are considered to be manageable.
Neželeni učinki zdravila veljajo za obvladljive.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bosulif have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Bosulif upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Bosulif are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Bosulif, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
After one year of treatment, 47% (116 out of 246) of patients treated with Bosulif had a major molecular response, compared with 37% (89 out of 241) of patients treated with imatinib.
Po enem letu zdravljenja je imelo 47 % (116 od 246) bolnikov, zdravljenih z zdravilom Bosulif, pomembni citogenetski odziv, v primerjavi s 37 % (89 od 241) bolnikov, zdravljenih z imatinibom.
Effectiveness was also measured in other ways including ‘haematological response' (a return to normal of the number of white cells in the blood).
Učinkovitost so merili tudi drugače, vključno s „hematološkim odzivom‟ (vrnitvijo števila belih krvnih celic na običajno raven).
An overview of Bosulif and why it is authorised in the EU
Pregled zdravila Bosulif in zakaj je odobreno v EU
Bosulif has been given ‘conditional authorisation'.
Zdravilo Bosulif je pridobilo „pogojno dovoljenje za promet“.
Why is Bosulif authorised in the EU?
Zakaj je bilo zdravilo Bosulif odobreno v EU?
What benefits of Bosulif have been shown in studies?
Kakšne koristi zdravila Bosulif so se pokazale v študijah?
Other information about Bosulif
Druge informacije o zdravilu Bosulif
What are the risks associated with Bosulif?
Kakšna tveganja so povezana z zdravilom Bosulif?
It blocks the action of enzymes known as Src and Bcr-Abl tyrosine kinases found on leukaemia cells where they are involved in stimulating the cells to divide uncontrollably.
Zavira delovanje encimov, ki jih imenujemo tirozin-kinaze Src in Bcr-Abl in ki jih najdemo na levkemičnih celicah, na katerih sodelujejo pri stimulaciji celic k nenadzorovani delitvi.
What is Bosulif and what is it used for?
Kaj je zdravilo Bosulif in za kaj se uporablja?
For more information about treatment with Bosulif, read the package leaflet (also part of the EPAR) or contact a doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Bosulif preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Bosulif must not be used in patients with reduced liver function.
Zdravila Bosulif ne smejo uporabljati bolniki z okvaro delovanja jeter.
Bosulif was investigated in one main study involving 570 patients with Ph+ CML who had previously been treated with at least one tyrosine kinase inhibitor.
Zdravilo Bosulif so proučevali v eni glavni študiji, ki je vključevala 570 bolnikov s KML Ph+, ki so se predhodno zdravili z vsaj enim zaviralcem tirozin-kinaze.
The active substance in Bosulif, bosutinib, is a tyrosine kinase inhibitor.
Zdravilna učinkovina v zdravilu Bosulif, bosutinib, je zaviralec tirozin-kinaze.