natgillin/translations-raw huggingface dataset:
For the full list of all side effects reported with pantoprazole, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi pantoprazola, glejte navodilo za uporabo.
It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantozol Control. 
Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Pantozol Control.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pantozol Control. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pantozol Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Pantozol Control is used for the short-term treatment of the symptoms of acid reflux in adults. 
Zdravilo Pantozol Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
What benefit has Pantozol Control shown during the studies? 
Kakšne koristi je zdravilo Pantozol Control izkazalo med študijami?
It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection). 
Zdravilo Pantozol Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
Pantozol Control is a medicine that contains the active substance pantoprazole. 
Zdravilo Pantozol Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
The reference medicine, Pantozol, is only available with a prescription. 
Referenčno zdravilo Pantozol se izdaja le na recept.
The active substance in Pantozol Control, pantoprazole, is a proton pump inhibitor. 
Zdravilna učinkovina zdravila Pantozol Control, pantoprazol, je zaviralec protonske črpalke.
Other information about Pantozol Control 
Druge informacije o zdravilu Pantozol Control:
What is the risk associated with Pantozol Control? 
Kakšna tveganja so povezana z zdravilom Pantozol Control?
Why has Pantozol Control been approved? 
Zakaj je bilo zdravilo Pantozol Control odobreno?
It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of 
Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Pantozol Control brez medicinskega nadzora ustrezna.
How has Pantozol Control been studied? 
Kako je bilo zdravilo Pantozol Control raziskano?
How does Pantozol Control work? 
Kako zdravilo Pantozol Control deluje?
What is Pantozol Control used for? 
Za kaj se zdravilo Pantozol Control uporablja?
How is Pantozol Control used? 
Kako se zdravilo Pantozol Control uporablja?
What is Pantozol Control? 
Kaj je zdravilo Pantozol Control?
Current Step 4 version dated July 2000. 
Trenutno veljavna različica 4. koraka iz julija 2000.
There are limited data on the long term outcomes. 
O dolgoročnih izidih so na voljo omejeni podatki.
The timetable for the implementation of the agreement is set out in Annex V. 
Časovni razpored za izvajanje sporazuma je opredeljen v Prilogi V.
In addition, the CMDh clarified that the study should be conducted in more than one Member State. 
Poleg tega je skupina CMDh pojasnila, da mora biti študija izvedena v več kot eni državi članici.
This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%. 
To pomeni, da je tveganje za večje malformacije večje kot pri splošni populaciji, pri kateri tveganje znaša približno 2-3 %.
Clinical Investigation of Medicinal Products in the Pediatric Population E11. 
Klinična raziskava zdravil pri pediatrični populaciji E11.
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation. 
Potem ko je pregledala priporočilo odbora PRAC, se je skupina CMDh strinjala s splošnimi znanstvenimi zaključki in podlago za priporočilo.
- Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures and partial epileptic seizures; 
− zdravljenje primarno generaliziranih epileptičnih napadov, sekundarno generaliziranih epileptičnih napadov in delnih epileptičnih napadov,
The incidence of risk appears to be higher with valproate than with other antiepileptics. 
Zdi se, da je incidenca tveganja pri uporabi valproata večja kot pri uporabi drugih antiepileptikov.
• The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for valproate and related substances-containing medicinal products. 
• Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo valproat in sorodne učinkovine;
The PRAC noted that in some Member States valproate is authorised for the prevention of migraine attacks. 
Odbor PRAC je upošteval, da je valproat v nekaterih državah članicah odobren za preprečevanje migrenskih napadov.
The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded. 
Točnega gestacijskega obdobja, v katerem se pojavi tveganje za te učinke, ni mogoče z gotovostjo opredeliti niti ni mogoče izključiti možnosti, da je tveganje prisotno celotno nosečnost.
The CMDh included a clarification about the population affected by the recommendations as these are also applicable to female adolescents (aged between 12 to 16-18 years) according to the ICH E11 age classification of the paediatric population10. 
Skupina CMDh je vključila pojasnilo v zvezi s populacijo, na katero se nanašajo priporočila, saj ta veljajo tudi za mladostnice (stare od 12 do 16-18 let) v skladu s starostno razvrstitvijo pediatrične populacije iz smernic ICH E1110.
This included the responses submitted by the marketing authorisation holders in writing and at oral explanation, as well as the outcome of the scientific advisory group in neurology. 
Med njimi so bili odgovori, ki so jih imetniki dovoljenja za promet z zdravilom podali v obliki pisne dokumentacije in ustne obrazložitve, ter tudi izidi sestanka znanstveno svetovalne skupine za nevrologijo.
The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems. 
Med najpogostejšimi vrstami malformacij so okvare nevralne cevi, dismorfizem obraza, heiloshiza in palatoshiza, kraniostenoza, okvare srca, ledvic in urogenitalnega trakta, okvare okončin (vključno z bilateralno aplazijo koželjnice) ter številne anomalije, ki prizadenejo različne organske sisteme.
1 - PRAC recommendation 
Priporočilo odbora PRAC
Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children. 
Podatki so pokazali, da ima lahko izpostavljenost valproatu in utero škodljive učinke na duševni in telesni razvoj izpostavljenih otrok.
Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems 2,3,4,5. 
Študije pri predšolskih otrocih, izpostavljenih valproatu in utero, kažejo, da se pri 30-40 % pojavi zaostanek v zgodnjem razvoju - na primer, da kasneje spregovorijo in shodijo, imajo manjše intelektualne sposobnosti, slabše jezikovne spretnosti (govorjenje in razumevanje) ter težave s spominom 2,3,4,5.
Minor editorial amendments were also introduced in the rest of the product information for clarity. 
Manjše redakcijske spremembe so zaradi jasnosti vključili tudi v druge dele informacij o zdravilu.
The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania. 
O nadaljnjem zdravljenju po manični epizodi se lahko razmisli pri bolnicah, ki so se odzvale na valproat pri akutni maniji;
Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29)1. 
Podatki, pridobljeni v metaanalizi (v katero so vključili tudi registre in kohortne študije), so pokazali, da so se pri 10,73 % otrok žensk z epilepsijo, ki so bile v nosečnosti izpostavljene monoterapiji z valproatom, pojavile prirojene malformacije (95-odstotni IZ: 8,16-13,29)1.
Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics. 
Inteligenčni količnik (IQ), izmerjen pri otrocih šoloobvezne starosti (6 let), ki so bili v preteklosti izpostavljeni valproatu in utero, je bil v povprečju za 7-10 točk nižji kot pri otrocih, izpostavljenih drugim antiepileptikom.
The PRAC agreed that targeted and appropriate information to healthcare professionals and patients were key to ensure a full understanding of the risks and that appropriate materials should be put in place. 
Odbor PRAC se je strinjal, da so ciljno usmerjene in primerne informacije za zdravstvene delavce ter bolnike ključne za zagotovitev popolnega razumevanja tveganj in da je treba pripraviti ustrezno gradivo.
The CMDh considered that the timeline for the submission of the drug utililsation study protocol should be extended in order to allow MAHs to perform a joint post-authorisation study (see Annex IV). 
Skupina CMDh je menila, da je treba roke za predložitev protokola študije o uporabi zdravila podaljšati, tako da bodo lahko imetniki dovoljenja za promet z zdravilom skupaj izvedli študijo po pridobitvi dovoljenja za promet (glejte Prilogo IV).
The PRAC reviewed all available data from pre-clinical studies, pharmacoepidemiological studies, published literature, spontaneous reports as well as the views of the relevant experts (i.e. in neurology, psychiatry, child neuropsychiatry, obstetrics etc.) on the safety and efficacy of valproate and related substances in female children, women of childbearing potential and pregnant women. 
Odbor PRAC je pregledal vse razpoložljive podatke iz predkliničnih študij, farmakoepidemioloških študij, objavljene literature in spontanih poročil ter mnenja zadevnih strokovnjakov (tj. strokovnjakov s področja nevrologije, psihiatrije, otroške nevropsihiatrije, porodništva itd.) o varnosti in učinkovitosti valproata in sorodnih učinkovin pri otrocih ženskega spola, ženskah v rodni dobi ter nosečnicah.
Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ6. 
Čeprav ni mogoče izključiti vloge sočasnih dejavnikov, obstajajo dokazi, da bi lahko bilo tveganje za intelektualno okvaro pri otrocih, izpostavljenih valproatu, neodvisno od inteligenčnega količnika matere6.
However, the CMDh emphasised that the referral procedure focussed on the risks associated with valproate and related substances in pregnant women and women of childbearing potential; the benefit-risk balance of valproate and related substances was assessed only in this subpopulation, and not in the general patient population for all indications. 
Vendar je skupina CMDh poudarila, da je bil napotitveni postopek osredotočen na tveganja, povezana z valproatom in sorodnimi učinkovinami pri nosečnicah in ženskah v rodni dobi - razmerje med tveganji in koristmi valproata in sorodnih učinkovin je bilo ocenjeno samo pri tej subpopulaciji, in ne pri splošni populaciji bolnikov za vse indikacije.
The review confirms the already known teratogenic risks associated with the use of valproate in pregnant women. 
Pregled je potrdil že znana tveganja za teratogenost, povezana z uporabo valproata pri nosečnicah.
The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, agreed on the variation to the terms of the marketing authorisations of valproate and related substances containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV. 
Skupina CMDh se je po proučitvi priporočila, ki ga je dne 9. oktobra 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES podal odbor PRAC, strinjala s spremembo pogojev dovoljenj za promet z zdravilom za zdravila, ki vsebujejo valproat in sorodne učinkovine, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III, in pod pogoji, določenimi v Prilogi IV.
The previous statements warning against the risks associated with valproate during pregnancy were summarised and included in rectangle frame. 
Prejšnje navedbe z opozorili glede tveganj, povezanih z valproatom v nosečnosti, so bile povzete in vključene v pravokoten okvir.
The CMDh also proposed a new timeline for the circulation of the DHPC in order to have it available to relevant recipients as soon as possible. 
Prav tako je skupina CMDh predlagala nove roke za razdelitev neposrednega obvestila zdravstvenim delavcem, tako da bo zadevnim prejemnikom na voljo čim prej.
The CMDh also considered the need to review the first part of the package leaflet for clarity reasons. 
Skupina CMDh je proučila tudi potrebo po ponovnem pregledu prvega dela navodila za uporabo zaradi večje jasnosti.
Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population. 
Razpoložljivi podatki kažejo, da pri otrocih, izpostavljenih valproatu in utero, obstaja večje tveganje za motnjo avtističnega spektra (približno trikrat večje) in otroški avtizem (približno petkrat večje) v primerjavi s splošno proučevano populacijo.
This follows the format used in the summary of product characteristics. 
Takšna oblika je skladna s tisto v povzetku glavnih značilnosti zdravila.
The PRAC also confirmed the known risk of congenital anomalies. 
Prav tako je odbor PRAC potrdil že znano tveganje za prirojene anomalije;
• The PRAC also concluded that there was a need for further risk minimisation measures such as educational materials aimed to better inform patients and healthcare professionals on the risks and a drug utilisation study to assess the effectiveness of the proposed risk minimisation measures. 
• odbor PRAC je prav tako zaključil, da so potrebni dodatni ukrepi za zmanjšanje tveganja, kot sta na primer izobraževalno gradivo, s katerim bi bolnike in zdravstvene delavce bolje seznanili s tveganji, in študija o uporabi zdravila, namenjena oceni učinkovitosti predlaganih ukrepov za zmanjšanje tveganja.
- Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. 
− zdravljenje manične epizode pri bipolarni motnji, kadar je litij kontraindiciran ali pa ga bolnice ne prenašajo.
The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data. 
Zdi se, da je tveganje odvisno od odmerka, vendar mejne velikosti odmerka, pod katero tveganje ni prisotno, na podlagi razpoložljivih podatkov ni mogoče določiti.
Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD)7,8,9. 
Omejeni podatki kažejo, da bi lahko obstajala večja verjetnost, da se bodo pri otrocih, izpostavljenih valproatu in utero, razvili simptomi motnje pomanjkanja pozornosti s hiperaktivnostjo (ADHD)7,8,9.
The CMDh considered the below PRAC recommendation with regard to valproate and related substances-containing medicinal products: 
Skupina CMDh je proučila spodnje priporočilo odbora PRAC v zvezi z zdravili, ki vsebujejo valproat in sorodne učinkovine:
The CMDh included a clarification on the use of prolonged release formulation to avoid high peak plasma concentrations in the summary of product characteristics. 
Skupina CMDh je v povzetek glavnih značilnosti zdravila vključila pojasnilo v zvezi z uporabo formulacije z dolgotrajnim sproščanjem, da bi preprečili visok porast koncentracije v plazmi.
• 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