natgillin/translations-raw huggingface dataset:
Given this and the negligible systemic exposure following topical use, the PRAC considered that no further risk minimization activities are deemed necessary. 
Glede na to in na zanemarljivo sistemsko izpostavljenost po lokalni uporabi je odbor PRAC ocenil, da nadaljnje aktivnosti za zmanjšanje tveganja niso potrebne.
The indications for the topical retinoids are non-life-threatening and there is no absolute clinical need for the treatment during pregnancy and pregnancy should be excluded before prescribing. 
ki niso življenjsko nevarna, zato ni absolutne klinične potrebe po zdravljenju med nosečnostjo.
• With regards to the teratogenic risk of topical retinoids (adapalene, alitretinoin, isotretinoin, tretinoin and tazarotene), the PRAC concluded that the data available show that after topical application, systemic exposure is expected to be negligible and unlikely to result in adverse fetal outcomes. 
• kar zadeva tveganje lokalnih retinoidov (adapalena, alitretinoina, izotretinoina, tretinoina in tazarotena) za teratogenost, je odbor PRAC zaključil, da razpoložljivi podatki kažejo, da je sistemska izpostavljenost po lokalni uporabi po pričakovanju zanemarljiva in ni verjetno, da bi pri plodu povzročila neželene izide.
• The PRAC considered the totality of the data submitted, including responses from the marketing authorisation holders with regard to the consistency and effectiveness of existing routine and additional risk minimisation measures for oral and topical retinoids-containing medicinal products in relation to teratogenic effects and neuropsychiatric disorders. 
• odbor PRAC je ocenil vse predložene podatke, vključno z odgovori imetnikov dovoljenj za promet z zdravilom, glede skladnosti in učinkovitosti obstoječih rutinskih in dodatnih ukrepov za zmanjšanje tveganja pri peroralnih in lokalnih zdravilih, ki vsebujejo retinoide, v zvezi s teratogenimi učinki in nevropsihiatričnimi motnjami.
• The PRAC further considered that for the oral retinoids acitretin, alitretinoin and isotretinoin a drug utilisation study with a complementary survey should be conducted to assess the effectiveness of the proposed updated risk minimisation measures. 
• odbor PRAC je nadalje menil, da je za peroralne retinoide acitretin, alitretinoin in izotretinoin treba opraviti študijo o uporabi zdravil z dopolnilno raziskavo, namenjeno oceni učinkovitosti predlaganih posodobljenih ukrepov za zmanjšanje tveganja;
In addition, the views of patients and healthcare professionals regarding communication, awareness and understanding of the risks of retinoids during pregnancy and in women of childbearing potential were taken into account in the recommendation along with their views on options for improving risk communication. 
Pri oblikovanju priporočila so upoštevali tudi stališča bolnikov in zdravstvenih delavcev glede obveščanja o tveganjih retinoidov med nosečnostjo in pri ženskah v rodni dobi, glede seznanjenosti s tveganji in njihovega razumevanja, upoštevali pa so tudi njihova stališča o možnostih za izboljšanje obveščanja o tveganju.
Given this and the negligible systemic exposure following topical no further risk minimization activities are deemed necessary. 
Glede na to in na zanemarljivo sistemsko izpostavljenost po lokalni uporabi nadaljnje aktivnosti za zmanjšanje tveganja niso potrebne.
For tretinoin and bexarotene, it was considered that in light of the oncological indications, specialist management in a hospital setting and population at risk that existing risk minimisation was appropriate and proportionate. 
Za tretinoin in beksaroten je bilo ocenjeno, da so obstoječi ukrepi za zmanjšanje tveganja v luči onkoloških indikacij, specialistične obravnave v bolnišničnem okolju in ogrožene populacije ustrezni in sorazmerni;
The PRAC thereby concludes that the benefit-risk balance of topical retinoids in pregnancy is not favourable, and therefore recommends that use of topical retinoids should be contraindicated during pregnancy and in women planning a pregnancy. 
Odbor PRAC torej zaključuje, da razmerje med tveganji in koristmi lokalnih retinoidov med nosečnostjo ni ugodno, zato priporoča kontraindikacijo za uporabo lokalnih retinoidov med nosečnostjo in pri ženskah, ki načrtujejo nosečnost.
• The PRAC also concluded that there was a need to further harmonise and streamline the measures in the PPP including associated educational materials for the oral retinoids acitretin, alitretinoin and isotretinoin to ensure these are optimal to support discussions between patients and healthcare professionals on the risks and the associated risk minimisation measures. 
• odbor PRAC je zaključil tudi, da je treba nadalje uskladiti in racionalizirati ukrepe v okviru programa preprečevanja nosečnosti, vključno s povezanimi izobraževalnimi gradivi za peroralne retinoide acitretin, alitretinoin in izotretinoin, da se zagotovi, da so ti ukrepi optimalni za podporo pogovorom med bolniki in zdravstvenimi delavci o tveganjih in povezanih ukrepih za zmanjšanje tveganja;
The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for retinoid-containing medicinal products. 
Odbor PRAC posledično priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo retinoide.
• Dissemination of the patient reminder card; 
• razdelitev opozorilnih kartic za bolnika;
In addition, the PRAC considered the views of patients and healthcare professionals in relation to their understanding and the awareness of the teratogenic risk associated with the use of retinoid-containing medicines. 
Odbor je upošteval tudi stališča bolnikov in zdravstvenih delavcev v zvezi z njihovim razumevanjem tveganja za teratogenost, povezanega z uporabo zdravil, ki vsebujejo retinoide, in seznanjenostjo s tem tveganjem;
In view of the above, the PRAC considers that the benefit-risk balance of retinoid-containing medicinal products remains favourable subject to the agreed amendments to the product information and risk management plan, the conditions to the marketing authorisations and the related communication. 
Glede na zgoraj navedeno odbor PRAC meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo retinoide, še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in načrta za obvladovanje tveganja, pogojev dovoljenj za promet z zdravilom in povezanega obveščanja.
In this respect, the PRAC recommended amendments to the product information, including harmonising the warnings and precautions of use for the oral retinoids acitretin, alitretinoin and isotretinoin to reflect the teratogenic risk associated with their use and communication to healthcare professionals through a direct healthcare professional communication. 
V zvezi s tem je odbor PRAC priporočil dopolnitev informacij o zdravilu, vključno z uskladitvijo opozoril in previdnostnih ukrepov za peroralne retinoide acitretin, alitretinoin in izotretinoin, da bodo vključevali tveganje za teratogenost, povezano z njihovo uporabo, in obveščanje zdravstvenih delavcev z neposrednimi obvestili za zdravstvene delavce.
Given the indications and patients populations that use acitretin, alitretinoin and isotretinoin, it was considered that any use of these oral retinoids in female patients at risk of pregnancy must be in accordance with the conditions of a pregnancy prevention programme (PPP). 
alitretinoin in izotretinoin, je bilo ocenjeno, da mora biti vsaka uporaba teh peroralnih retinoidov pri bolnicah s tveganjem za nosečnost v skladu s pogoji programa preprečevanja nosečnosti.
The human data on congenital malformations after oral retinoid exposure show a significant risk of retinoid embryopathy (of up to 30% of fetuses exposed); furthermore it is known that approximately one-third of pregnant patients exposed to oral retinoids during pregnancy will have spontaneous abortions. 
Podatki o prirojenih malformacijah pri ljudeh po izpostavljenosti peroralnim retinoidom kažejo precejšnje tveganje za retinoidno embriopatijo (do 30 % izpostavljenih plodov).
PRAC considered that given the oncological indications of oral tretinoin and oral bexarotene, further risk minimisation measures (RMMs) for these products regarding teratogenic effects, such as strengthening the product information (PI) and additional risk minimisation measures (aRMMs) would not provide an added value given the specialist management, the population at risk and the nature of the illness. 
Odbor PRAC je presodil, da glede na onkološke indikacije peroralnega tretinoina in peroralnega beksarotena in zaradi specialistične obravnave, ogrožene populacije in narave bolezni nadaljnji ukrepi za zmanjšanje tveganja za ti zdravili glede teratogenih učinkov, kot so okrepitev informacij o zdravilu,
Furthermore, specific studies to measure effectiveness of the agreed changes to the PPP have been imposed on the marketing authorisation holders as an outcome of the referral. 
Nadalje je bila kot izid napotitve imetnikom dovoljenj za promet z zdravilom naložena izvedba posebnih študij za ugotavljanje učinkovitosti dogovorjenih sprememb programov preprečevanja nosečnosti.
• Furthermore, the PRAC noted the extremely limited data relating to neuropsychiatric reactions after topical administration of retinoids. 
• odbor PRAC je nadalje ugotovil, da so podatki o nevropsihiatričnih učinkih po lokalnem dajanju retinoidov zelo omejeni.
Overall, the PRAC concludes that the benefit-risk balance of medicinal products containing retinoids remains favourable, but that marketing authorisation(s) should be varied for both the oral and topical retinoids to ensure risks associated with the adverse teratogenic effects and neuropsychiatric disorders are accurately and consistently addressed, as appropriate. 
ostaja ugodno, vendar je treba spremeniti dovoljenja za promet z zdravilom za peroralne in lokalne retinoide, da se zagotovi točna in skladna obravnava tveganj, povezanih z neželenimi teratogenimi učinki in nevropsihiatričnimi motnjami, kot ustreza.
The PRAC further noted the extremely limited data relating to neuropsychiatric reactions after topical administration of retinoids. 
Odbor PRAC je nadalje ugotovil, da so podatki o nevropsihiatričnih učinkih po lokalnem dajanju retinoidov zelo omejeni.
The PRAC was requested to assess the impact of the above concerns on the benefit-risk balance of retinoid-containing medicinal products and issue a recommendation on whether the products should be maintained, varied, suspended or revoked. 
ter izda priporočilo o tem, ali naj se ta zdravila ohranijo, spremenijo, začasno umaknejo ali prekličejo.
The CHMP, as a consequence, considers that the benefit-risk balance of retinoid-containing medicinal products remains favourable subject to the agreed amendments to the product information and risk management plan, the conditions to the marketing authorisations and the related communication. 
še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu in načrta za obvladovanje tveganja, pogojev dovoljenj za promet z zdravilom in povezanega obveščanja.
In addition, the PRAC recommended changes to the educational materials for the oral retinoids (acitretin, alitretinoin and isotretinoin) to ensure healthcare professionals and patients are informed about the risks associated with oral retinoids (acitretin, alitretinoin and isotretinoin) in pregnant women and women of child-bearing potential and on the measures necessary to minimise the risk. 
Poleg tega je odbor PRAC priporočil spremembe izobraževalnih gradiv za peroralne retinoide (acitretin, alitretinoin in izotretinoin), da se zagotovi obveščenost zdravstvenih delavcev in bolnikov o tveganjih, povezanih s peroralnimi retinoidi
The PRAC therefore recommended that the use of topical retinoids should be contraindicated during pregnancy and in women planning a pregnancy given the non-life threatening nature of the indications. 
Odbor PRAC zato priporoča, da je treba uporabo lokalnih retinoidov med nosečnostjo in pri ženskah, ki načrtujejo nosečnost,
The daily dose is divided into two halves, taken morning and evening about 12 hours apart. 
Dnevni odmerek je razdeljen na dve polovici, ki se vzameta zjutraj in zvečer v razmiku približno 12 ur.
The European Medicines Agency decided that Inovelon's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Inovelon večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Inovelon? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Inovelon?
Inovelon received a marketing authorisation valid throughout the EU on 16 January 2007. 
Za zdravilo Inovelon je bilo 16. januarja 2007 izdano dovoljenje za promet, veljavno po vsej EU.
The dose is then adjusted every other day according to the patient's response to treatment. 
Ta odmerek se nato glede na odziv bolnika na zdravljenje vsak drugi dan prilagodi.
Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children. 
Lennox-Gastautov sindrom je ena od najtežjih oblik epilepsije pri otrocih.
As for all medicines, data on the use of Inovelon are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Inovelon stalno spremljajo.
Further information on Inovelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Inovelon so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In older patients, treatment usually starts with a dose of 200 or 400 mg daily. 
Pri starejših bolnikih se zdravljenje običajno začne z dnevnim odmerkom 200 mg ali 400 mg.
Given that the disease behaves the same way in both age groups, Inovelon could therefore be expected to act similarly in children aged 1 to 4 years. 
Ker bolezen poteka enako v obeh starostnih skupinah, bi bilo zato mogoče za zdravilo Inovelon pričakovati, da bo delovalo podobno pri otrocih, starih od enega do štirih let.
Inovelon should be taken with water and food. 
Zdravilo Inovelon je treba zaužiti skupaj z vodo in hrano.
By attaching to the channels, rufinamide prevents them switching from an inactive state to an active state. 
Ko se rufinamid veže nanje, jim prepreči, da bi prešli iz nedejavnega v dejavno stanje.
Treatment in children less than 4 years of age generally starts with a daily dose of 10 mg per kilogram body weight. 
Zdravljenje otrok, mlajših od štirih let, se na splošno začne z dnevnim odmerkom 10 mg na kilogram telesne mase.
Other information about Inovelon 
Druge informacije o zdravilu Inovelon
The company also presented the results of a study showing that the oral suspension produced the same levels of the active substance in the blood as the tablets. 
Družba je predložila tudi rezultate študije, iz katerih je razvidno, da je peroralna suspenzija v krvi proizvedla enake ravni zdravilne učinkovine kot tablete.
A study involving 37 children aged 1 to 4 years was inconclusive because of its small size and because it was not designed to show benefit. 
Rezultati študije, v katero je bilo vključenih 37 otrok, starih od enega do štirih let, so bili nezanesljivi, ker je bila premajhna in ni bila zasnovana za prikaz koristi.
This dampens down the activity of the brain cells and prevents abnormal electrical activity from spreading through the brain. 
To zavira delovanje možganskih celic in prepreči širjenje nenormalne električne dejavnosti po možganih.
The most common side effects with Inovelon (seen in more than 1 in 10 patients) are sleepiness, headache, dizziness, vomiting, and tiredness. 
Najpogostejši neželeni učinki zdravila Inovelon (opaženi pri več kot 1 bolniku od 10) so zaspanost, glavobol, vrtoglavica, bruhanje in utrujenost.
Side effects reported with Inovelon are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Inovelon, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inovelon 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 Inovelon upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Inovelon? 
Kakšna tveganja so povezana z zdravilom Inovelon?
An overview of Inovelon and why it is authorised in the EU 
Pregled zdravila Inovelon in zakaj je odobreno v EU
All of the patients had Lennox-Gastaut syndrome that was not controlled despite continuous treatment for at least four weeks with up to three other anti-epileptic medicines. 
Vsi bolniki so imeli Lennox-Gastautov sindrom, ki ga kljub neprekinjenemu najmanj štiritedenskemu zdravljenju z do tremi drugimi zdravili za zdravljenje epilepsije ni bilo mogoče obvladati.
Why is Inovelon authorised in the EU? 
Zakaj je bilo zdravilo Inovelon odobreno v EU?
This reduces the likelihood of a seizure occurring. 
S tem se zmanjša verjetnost nastopa epileptičnega napada.
In a main study involving 139 patients aged between 4 and 30 years (three quarters of them below 17 years old) Inovelon caused a reduction in the number and severity of seizures. 
V glavni študiji, v katero je bilo vključenih 139 bolnikov, starih od štiri do 30 let (tri četrtine so bile mlajše od 17 let), je zdravilo Inovelon zmanjšalo število in resnost epileptičnih napadov.
For more information about using Inovelon, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Inovelon glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
However, other analyses showed that doses based on body weight in children aged 1 to 4 years produced similar levels of the medicine in the body to those seen with standard doses in older patients. 
Vendar pa so druge analize pokazale, da odmerki na podlagi telesne mase pri otrocih od enega do štirih let starosti proizvedejo podobne ravni zdravila v telesu kot običajni odmerki pri starejših bolnikih.
Lennox-Gastaut syndrome is rare, and Inovelon was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004. 
Lennox-Gastautov sindrom je redek, zato je bilo zdravilo Inovelon 20. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The main measures of effectiveness were the change in the number of seizures in the four weeks after Inovelon or placebo was added, compared with the four weeks before it was added, as well as the change in severity of seizures assessed on a 7-point scale by the patient's parent or guardian. 
Glavni merili učinkovitosti sta bili sprememba števila napadov v štirih tednih po dodajanju zdravila Inovelon ali placeba v primerjavi s štirimi tedni pred njunim dodajanjem ter sprememba resnosti napadov, ki so jo ocenili bolnikovi starši ali skrbniki na podlagi lestvice od 1 do 7.
What is Inovelon and what is it used for? 
Kaj je zdravilo Inovelon in za kaj se uporablja?
The active substance in Inovelon, rufinamide, acts by attaching to special channels (sodium channels) on brain cells that control their electrical activity. 
Zdravilna učinkovina v zdravilu Inovelon, rufinamid, deluje tako, da se veže na posebne kanalčke na površini možganskih celic (natrijeve kanalčke), ki nadzirajo električno delovanje celic.
Inovelon is an epilepsy medicine used to treat patients aged one year or older who have LennoxGastaut syndrome, a rare type of epilepsy that usually affects children but which can continue into adulthood. 
Inovelon je zdravilo, ki se uporablja za zdravljenje epilepsije pri bolnikih, starejših od enega leta, z Lennox-Gastautovim sindromom, tj. redko obliko epilepsije, ki navadno prizadene otroke, a se lahko nadaljuje tudi v odraslem obdobju.
The medicine should not be used in patients who have severe problems with their liver. 
Zdravila Inovelon ne smejo jemati bolniki s hudimi težavami z jetri.
Its symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems. 
Simptomi tega sindroma so različne vrste epileptičnih napadov, nenormalna električna dejavnost možganov, nezmožnost učenja in vedenjske težave.
Patients taking Inovelon had a 35.8% reduction in the total number of seizures, falling from an average of 290 seizures in the four-week period before Inovelon was started. 
Pri bolnikih, ki so jemali zdravilo Inovelon, se je število vseh napadov zmanjšalo za 35,8 % od povprečno 290 napadov v štirih tednih pred začetkom jemanja zdravila Inovelon.
Patients adding Inovelon also had a 42.5% reduction in the number of ‘tonic-atonic' seizures (a common type of fit in patients with Lennox-Gastaut syndrome that often involves the patient dropping to the floor), compared with a 1.9% increase in those adding placebo. 
Pri bolnikih, ki so dodajali zdravilo Inovelon, so opazili tudi zmanjšanje števila tonično-atoničnih napadov (vrste napadov, ki so običajno prisotni pri bolnikih z Lennox-Gastautovim sindromom, pri katerih bolnik pogosto pade na tla) za 42,5 %, v primerjavi z 1,9-odstotnim povečanjem pri tistih, ki so kot dodatek jemali placebo.
Inovelon contains the active substance rufinamide. 
Zdravilo Inovelon vsebuje zdravilno učinkovino rufinamid.
What benefits of Inovelon have been shown in studies? 
Kakšne koristi je zdravilo Inovelon izkazalo med študijami?
Inovelon is used as an add-on to other anti-epileptic medicines. 
Zdravilo Inovelon se uporablja kot dodatek zdravljenju z drugimi zdravili za preprečevanje epileptičnih napadov.
Inovelon must not be used in patients who are hypersensitive (allergic) to rufinamide, triazole derivatives (such as some medicines used to treat fungal infections) or any of the other ingredients. 
Zdravilo Inovelon se ne sme uporabljati pri bolnikih, ki utegnejo biti preobčutljivi za (alergični na) rufinamid, derivate triazola (kot so nekatera zdravila za zdravljenje glivičnih okužb) ali katero koli drugo sestavino zdravila.
The dose of Inovelon depends on the patient's age and weight and whether the patient is also taking valproate (another anti-epileptic medicine). 
Odmerek zdravila Inovelon je odvisen od starosti in telesne mase bolnika ter tega, ali bolnik jemlje tudi valproat (drugo zdravilo za zdravljenje epilepsije).
The study compared the effects of adding Inovelon tablets or adding placebo (a dummy treatment) to the other medicines the patients were taking. 
V študiji so primerjali učinke dodajanja tablet zdravila Inovelon ali dodajanja placeba (zdravila brez zdravilne učinkovine) k drugim zdravilom, ki so jih jemali bolniki.
An improvement in the severity of seizures was reported for about half of the patients adding Inovelon, compared with a third of those adding placebo. 
O zmanjšanju resnosti napadov so poročali pri približno polovici bolnikov, ki so kot dodatno zdravilo prejemali Inovelon, v primerjavi s tretjino tistih, ki so kot dodatno zdravilo prejemali placebo.
For the full list of side effects of Inovelon, see the package leaflet. 
Za celoten seznam neželenih učinkov zdravila Inovelon glejte navodilo za uporabo.
Inovelon can only be obtained with a prescription and treatment should be started by a paediatrician (a doctor specialised in treating children) or a neurologist (a doctor who treats brain disorders) experienced in the treatment of epilepsy. 
Predpisovanje in izdaja zdravila Inovelon je le na recept, zdravljenje pa mora začeti pediater (zdravnik, ki je specializiran za zdravljenje otrok) ali nevrolog (zdravnik, ki zdravi možganske bolezni).
How is Inovelon used? 
Kako se zdravilo Inovelon uporablja?
There was a 1.6% reduction in the patients who added placebo to their existing treatment. 
Pri bolnikih, ki so kot pomožno zdravilo prejemali placebo, so opazili 1,6-odstotno zmanjšanje števila napadov.
Its terminal half-life is about one day. 
Njegova končna razpolovna doba je približno en dan.