FrancophonIA/ELRC3.0 huggingface dataset:
English: No adverse effects on fertility or general reproduction were seen following once weekly intravenous injections of cidofovir in male rats for 13 consecutive weeks at doses up to 15 mg/kg/week.
Slovenian: Po intravenskem injiciranju cidofovira podganjim samcem enkrat na teden 13 tednov zapored v odmerkih do 15 mg/kg/teden niso ugotovili neželenih učinkov na plodnost ali splošno reprodukcijsko sposobnost.
English: Eye disorders Common
Slovenian: Očesne bolezni Pogosti
English: Each vial contains 375 mg/5 ml cidofovir anhydrous as the active substance.
Slovenian: Ena viala kot zdravilno učinkovino vsebuje 375 mg/5 ml brezvodnega cidofovira.
English: Food should be taken before you are given Vistide.
Slovenian: Pred uporabo zdravila Vistide morate zaužiti hrano.
English: 23 April 2007
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 23.4.2007
English: Elderly population:
Slovenian: Starejši:
English: • You should not be given Vistide if you are breast-feeding.
Slovenian: • Če dojite, ne smete dobiti zdravila Vistide.
English: particular attention should be paid to assessing renal function before and during administration of Vistide.
Slovenian: Starejši imajo pogosto zmanjšano delovanje glomerulov, zato je treba pred aplikacijo zdravila Vistide in med njo posebno pozornost nameniti oceni delovanja ledvic.
English: Interruption, and possibly discontinuation, is required for changes in renal function.
Slovenian: Če se delovanje ledvic spremeni, je treba uporabo zdravila prekiniti in morda končati.
English: (Invented) name Strength Pharmaceutical form Route of administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: You may need urgent medical treatment.
Slovenian: Morda boste potrebovali nujno medicinsko pomoč.
English: Adopted at the 6-9 July 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC, 6.-9. julija 2015
English: Donepezil - Rhabdomyolysis (EPITT no 18261)
Slovenian: Donepezil - rabdomioliza (EPITT št. 18261)
English: Remember to also mention any other ill-effects like pain in your joints.
Slovenian: Ne pozabite omeniti morebitnih drugih neželenih učinkov, kot je bolečina v sklepih.
English: • if you have ever had a skin reaction after treatment with a medicine similar to {Drug name} that reduces stomach acid.
Slovenian: • če ste že kdaj imeli kožno reakcijo po zdravljenju z zdravilom, podobnim zdravilu {Ime zdravila}, ki zmanjšuje izločanje želodčne kisline.
English: Dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Subacute cutaneous lupus erythematosus (EPITT no 18119)
Slovenian: Dekslansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol, rabeprazol - subakutni kožni eritematozni lupus (EPITT št. 18119)
English: Section 4: Possible side effects • Frequency 'not known': rash, possibly with pain in the joints
Slovenian: Poglavje 4: Možni neželeni učinki • Pogostnost „neznana“: izpuščaj, lahko z bolečino v sklepih
English: Summary of Product Characteristics (both prescription and non-prescription)
Slovenian: Povzetek glavnih značilnosti zdravila (na recept in brez recepta)
English: Musculoskeletal, connective tissue and bone disorders Frequency ‘very rare': Rhabdomyolysis* (To be inserted in the table footnote): * Rhabdomyolysis has been reported to occur independently of neuroleptic malignant syndrome and in close temporal association with donepezil initiation or dose increase.
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogostnost „zelo redki“: rabdomioliza* (vstaviti v opombe preglednice): * Poročali so o pojavu rabdomiolize, neodvisnem od nevroleptičnega malignega sindroma in v tesni časovni povezavi z uvedbo ali povečanjem odmerka donepezila.
English: Frequency 'not known': Subacute cutaneous lupus erythematosus (see section 4.4).
Slovenian: Pogostnost „neznana“: subakutni kožni eritematozni lupus (glejte poglavje 4.4).
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping {Drug name}.
Slovenian: Če se pojavijo lezije, zlasti na koži, ki je izpostavljena soncu, in sočasna artralgija, mora bolnik takoj poiskati zdravniško pomoč, zdravstveni delavec pa mora razmisliti o prekinitvi zdravljenja z zdravilom {Ime zdravila}.
English: • Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Slovenian: • Šibkost mišic, občutljivost na dotik ali bolečina, zlasti če to spremlja slabo počutje, povišana telesna temperatura ali temen urin.
English: They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis).
Slovenian: Te simptome lahko povzroča nenormalna razgradnja mišic, ki je lahko smrtno nevarna in povzroči težave z ledvicami (stanje, imenovano rabdomioliza).
English: If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with {Drug name}.
Slovenian: Če se pojavi kožni izpuščaj, zlasti na koži, ki je izpostavljena soncu, čim prej obvestite zdravnika, saj boste morda morali prekiniti zdravljenje z zdravilom {Ime zdravila}.
English: Section 4: Possible side effects
Slovenian: Poglavje 4: Možni neželeni učinki
English: Proton pump inhibitors are associated with very infrequent cases of SCLE.
Slovenian: Zaviralci protonske črpalke so povezani z zelo redkimi primeri subakutnega kožnega eritematoznega lupusa.
English: Talk to your doctor before taking {Drug name}:
Slovenian: Preden vzamete zdravilo {Ime zdravila}, se morate posvetovati z zdravnikom:
English: SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Slovenian: Subakutni kožni eritematozni lupus po predhodnem zdravljenju z zaviralcem protonske črpalke lahko poveča tveganje za pojav subakutnega1 kožnega eritematoznega lupusa z drugimi zaviralci protonske črpalke.
English: You must tell your doctor immediately if you notice these serious side effects mentioned.
Slovenian: Če opazite navedene resne neželene učinke, morate o njih takoj obvestiti zdravnika.
English: Section 2: What you need to know before you take {Drug name}
Slovenian: Navodilo za uporabo (na recept in brez recepta) Poglavje 2: Kaj morate vedeti, preden boste vzeli zdravilo {Ime zdravila} Opozorila in previdnostni ukrepi
English: Subacute cutaneous lupus erythematosus (SCLE)
Slovenian: Subakutni kožni eritematozni lupus
English: Skin and subcutaneous tissue disorders
Slovenian: Poglavje 4.8 - Neželeni učinki Bolezni kože in podkožja
English: The full EPAR for Pantozol Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pantozol Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Pantozol Control on 12 June 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pantozol Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
English: The recommended dose of Pantozol Control is one tablet once a day until symptoms have stopped.
Slovenian: Priporočeni odmerek zdravila Pantozol Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
English: Pantozol Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantozol.
Slovenian: Zdravilo Pantozol Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Pantozol.
English: This is a summary of the European public assessment report (EPAR) for Pantozol Control.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pantozol Control.
English: The most common side effects with Pantozol Control (seen in around 1 patient in 100) are diarrhoea and headache.
Slovenian: Najpogostejša neželena učinka zdravila Pantozol Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
English: For more information about treatment with Pantozol Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pantozol Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Pantozol Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Slovenian: Zdravila Pantozol Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
English: Pantozol Control pantoprazole
Slovenian: Pantozol Control pantoprazol
English: The CHMP therefore decided that Pantozol Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je zaključil, da so koristi zdravila Pantozol Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For the full list of all side effects reported with pantoprazole, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi pantoprazola, glejte navodilo za uporabo.
English: 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.
Slovenian: Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Pantozol Control.
English: 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.
Slovenian: 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.
English: Pantozol Control is used for the short-term treatment of the symptoms of acid reflux in adults.
Slovenian: Zdravilo Pantozol Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
English: What benefit has Pantozol Control shown during the studies?
Slovenian: Kakšne koristi je zdravilo Pantozol Control izkazalo med študijami?
English: It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection).
Slovenian: Zdravilo Pantozol Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
English: Pantozol Control is a medicine that contains the active substance pantoprazole.
Slovenian: Zdravilo Pantozol Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
English: The reference medicine, Pantozol, is only available with a prescription.
Slovenian: Referenčno zdravilo Pantozol se izdaja le na recept.
English: The active substance in Pantozol Control, pantoprazole, is a proton pump inhibitor.
Slovenian: Zdravilna učinkovina zdravila Pantozol Control, pantoprazol, je zaviralec protonske črpalke.
English: Other information about Pantozol Control
Slovenian: Druge informacije o zdravilu Pantozol Control:
English: What is the risk associated with Pantozol Control?
Slovenian: Kakšna tveganja so povezana z zdravilom Pantozol Control?
English: Why has Pantozol Control been approved?
Slovenian: Zakaj je bilo zdravilo Pantozol Control odobreno?
English: It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of
Slovenian: Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Pantozol Control brez medicinskega nadzora ustrezna.
English: How has Pantozol Control been studied?
Slovenian: Kako je bilo zdravilo Pantozol Control raziskano?
English: How does Pantozol Control work?
Slovenian: Kako zdravilo Pantozol Control deluje?
English: What is Pantozol Control used for?
Slovenian: Za kaj se zdravilo Pantozol Control uporablja?
English: How is Pantozol Control used?
Slovenian: Kako se zdravilo Pantozol Control uporablja?
English: What is Pantozol Control?
Slovenian: Kaj je zdravilo Pantozol Control?
English: Current Step 4 version dated July 2000.
Slovenian: Trenutno veljavna različica 4. koraka iz julija 2000.
English: There are limited data on the long term outcomes.
Slovenian: O dolgoročnih izidih so na voljo omejeni podatki.
English: The timetable for the implementation of the agreement is set out in Annex V.
Slovenian: Časovni razpored za izvajanje sporazuma je opredeljen v Prilogi V.
English: In addition, the CMDh clarified that the study should be conducted in more than one Member State.
Slovenian: Poleg tega je skupina CMDh pojasnila, da mora biti študija izvedena v več kot eni državi članici.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Slovenian: To pomeni, da je tveganje za večje malformacije večje kot pri splošni populaciji, pri kateri tveganje znaša približno 2-3 %.
English: Clinical Investigation of Medicinal Products in the Pediatric Population E11.
Slovenian: Klinična raziskava zdravil pri pediatrični populaciji E11.
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Slovenian: Potem ko je pregledala priporočilo odbora PRAC, se je skupina CMDh strinjala s splošnimi znanstvenimi zaključki in podlago za priporočilo.
English: - Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures and partial epileptic seizures;
Slovenian: − zdravljenje primarno generaliziranih epileptičnih napadov, sekundarno generaliziranih epileptičnih napadov in delnih epileptičnih napadov,
English: The incidence of risk appears to be higher with valproate than with other antiepileptics.
Slovenian: Zdi se, da je incidenca tveganja pri uporabi valproata večja kot pri uporabi drugih antiepileptikov.
English: • 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.
Slovenian: • 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;
English: The PRAC noted that in some Member States valproate is authorised for the prevention of migraine attacks.
Slovenian: Odbor PRAC je upošteval, da je valproat v nekaterih državah članicah odobren za preprečevanje migrenskih napadov.
English: The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 1 - PRAC recommendation
Slovenian: Priporočilo odbora PRAC
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Slovenian: Podatki so pokazali, da ima lahko izpostavljenost valproatu in utero škodljive učinke na duševni in telesni razvoj izpostavljenih otrok.
English: 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.
Slovenian: 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.
English: Minor editorial amendments were also introduced in the rest of the product information for clarity.
Slovenian: Manjše redakcijske spremembe so zaradi jasnosti vključili tudi v druge dele informacij o zdravilu.
English: The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.
Slovenian: O nadaljnjem zdravljenju po manični epizodi se lahko razmisli pri bolnicah, ki so se odzvale na valproat pri akutni maniji;
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The review confirms the already known teratogenic risks associated with the use of valproate in pregnant women.
Slovenian: Pregled je potrdil že znana tveganja za teratogenost, povezana z uporabo valproata pri nosečnicah.
English: 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.
Slovenian: 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.
English: The previous statements warning against the risks associated with valproate during pregnancy were summarised and included in rectangle frame.
Slovenian: Prejšnje navedbe z opozorili glede tveganj, povezanih z valproatom v nosečnosti, so bile povzete in vključene v pravokoten okvir.
English: Intellectual and language functions in children of mothers with epilepsy.
Slovenian: 4 Thomas SV et al. Intellectual and language functions in children of mothers with epilepsy.
English: 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.
Slovenian: Prav tako je skupina CMDh predlagala nove roke za razdelitev neposrednega obvestila zdravstvenim delavcem, tako da bo zadevnim prejemnikom na voljo čim prej.
English: The CMDh also considered the need to review the first part of the package leaflet for clarity reasons.
Slovenian: Skupina CMDh je proučila tudi potrebo po ponovnem pregledu prvega dela navodila za uporabo zaradi večje jasnosti.