natgillin/translations-raw huggingface dataset:
The first study involved 154 patients with spinal progressive multiple sclerosis. 
V prvo študijo je bilo vključenih 154 bolnikov s progresivno
measure of effectiveness was the number of patients whose overall disability decreased and whose ability to walk improved. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je skupna prizadetost sčasoma zmanjšala in zmožnost hoje izboljšala.
The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment). 
Družba je predstavila podatke dveh glavnih študij, v katerih so zdravilo Qizenday primerjali s placebom (zdravilom brez zdravilne učinkovine).
Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate. 
Zdravilo Qizenday naj bi se uporabljalo za zdravljenje odraslih s progresivno obliko multiple skleroze, bolezni, pri kateri pride do poškodbe zaščitne ovojnice okrog živčnih celic v možganih in hrbtenjači, živci pa postopoma degenerirajo.
On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis. 
Družba Medday Pharmaceuticals je 13. novembra 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Qizenday, namenjenim zdravljenju progresivne multiple skleroze.
Withdrawal of the marketing authorisation application for Qizenday (biotin) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Qizenday (biotin)
What is Qizenday? 
Kaj je zdravilo Qizenday?
How does Qizenday work? 
Kako zdravilo Qizenday deluje?
The CHMP considered that the data on the medicine's effectiveness were not robust enough, and that there were uncertainties regarding the medicine's safety given the small number of patients treated with Qizenday. 
Odbor CHMP je presodil, da podatki o učinkovitosti zdravila niso dovolj zanesljivi in da zaradi majhnega števila bolnikov, zdravljenih z zdravilom Qizenday, obstajajo nejasnosti o njegovi varnosti.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Qizenday. 
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Qizenday.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umik temelji na mnenju CHMP, da predstavljeni klinični podatki odboru ne dovoljujejo, da bi pozitivno ocenil razmerje med tveganji in koristmi zdravila Qizenday.
What was Qizenday expected to be used for? 
Za kaj naj bi se zdravilo Qizenday uporabljalo?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qizenday did not outweigh its risks. 
Zato je odbor CHMP ob umiku vloge menil, da koristi zdravila Qizenday ne odtehtajo z njim povezanih tveganj.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis. 
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Qizenday ni mogoče odobriti za zdravljenje progresivne multiple skleroze.
These checks may include: 
Te preiskave lahko vključujejo:
31-January-2022 
31. januar 2022.
• you have fainted recently 
• ste pred nedavnim omedleli;
Date of first authorisation: 17/09/2015 
Datum prve odobritve: 17. september 2015
Adolescent subjects must weigh at least 34 kg. 
Mladostniki morajo tehtati vsaj 34 kg.
They can find it hard to behave well at home, at school or in other places. 
Težko se lepo vedejo doma, v šoli in drugod.
Not known (cannot be estimated from the available data). 
neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This is because this medicine can make these problems worse. 
To zdravilo namreč lahko poslabša te težave.
ADHD can cause problems with everyday life. 
ADHD lahko povzroča težave v vsakdanjem življenju.
It is recommended clinical judgement be exercised during this period. 
Priporočljivo je, da v tem obdobju uporabljate klinično presojo.
• concentrate. 
• se osredotočijo.
Children under 6 years 
Otroci, mlajši od 6 let
Submission of final study Report: 
Predložitev končnega poročila študije:
This will show if you still need to take the medicine. 
Tako se bo izkazalo, ali morate zdravilo jemati še naprej.
• This medicine should be taken once a day either in the morning or evening. 
• To zdravilo je treba jemati enkrat na dan, bodisi zjutraj bodisi zvečer.
• seeing or hearing things that are not there (hallucination). 
• vidite ali slišite stvari, ki jih v resnici ni (halucinacija).
Take the medicine pack with you and tell them how much you have taken. 
Vzemite ovojnino zdravila s seboj in jim povejte, koliko zdravila ste vzeli.
These small changes are not expected to be clinically meaningful. 
Ni pričakovati, da so te majhne spremembe klinično pomembne.
ADHD does not affect the intelligence of a child or young person. 
ADHD ne vpliva na inteligentnost otroka ali mlade osebe.
Tel + 44 (0) 1256 894 959 e-mail medinfoEMEA@shire.com 
Tel + 44 (0) 1256 894 959 e-pošta medinfoEMEA@shire.com
• This leaflet has been written as though the person taking the medicine is reading it. 
• To navodilo je napisano, kot da ga bo brala oseba, ki jemlje zdravilo.
This medicine belongs to a group of medicines which affects brain activity. 
To zdravilo spada v skupino zdravil, ki vplivajo na aktivnost možganov.
Your doctor may want to review your treatment. 
Zdravnik bo mogoče želel spet pretehtati vaše zdravljenje.
If you are giving this medicine to your child, please replace “you” with “your child” throughout. 
Če dajete to zdravilo svojemu otroku, po vsem navodilu zamenjajte besedico “vi” z besedama “vaš otrok”.
This medicine can help improve your attention, concentration and make you less impulsive and hyperactive. 
To zdravilo vam lahko pomaga izboljšati pozornost in koncentracijo in vas narediti manj nepremišljenega in hiperaktivnega.
Syncope has also been observed. 
Opazili so tudi sinkopo.
People with ADHD find it hard to: 
Ljudje z ADHD težko:
Summary of primary efficacy for study SPD503-316: ADHD-RS-IV 
Povzetek primarne učinkovitosti za študijo SPD503-316: ADHD-RS-IV
If you forget a dose, wait until the next day and take your usual dose. 
Če pozabite vzeti odmerek, počakajte do drugega dne in takrat vzemite običajni odmerek.
Therefore, a risk on the breast-fed infant cannot be excluded. 
Zato tveganja za dojenčka ne moremo izključiti.
• Do not take this medicine if you are pregnant or you are not using contraception. 
• Ne jemljite tega zdravila, če ste noseči ali če ne uporabljate kontracepcije.
The Educational material and Prescriber checklist shall contain the following key messages: 
Izobraževalno gradivo in kontrolni seznam za predpisovanje zdravila morata vsebovati naslednja ključna sporočila:
Formal pharmacokinetic studies for race have not been conducted. 
Formalnih farmakokinetičnih študij za rase niso izvedli.
• Educational material (including prescriber checklist) for the healthcare professionals 
• izobraževalno gradivo (vključno s kontrolnim seznamom za predpisovanje) za zdravstvene delavce.
Results of the secondary endpoints were consistent with that of the primary endpoint. 
Rezultati sekundarnih končnih stanj so se ujemali z rezultati primarnega končnega stanja.
Activated charcoal may be useful in limiting the absorption. 
Za zmanjševanje absorpcije je lahko koristno aktivno oglje.
Children and young people with ADHD may have difficulty learning and doing homework. 
Otroci in mladi ljudje z ADHD se včasih težko učijo in delajo domače naloge.
Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible change in the ADHD treatment programme. 
Mogoče bo potrebno zdravljenje osnovne psihiatrične bolezni, pretehtati pa je treba tudi možnost spremembe programa zdravljenja ADHD.
Treatment is recommended only for children who are able to swallow the tablet whole without problems. 
Zdravljenje priporočajo le za otroke, ki lahko brez težav pogoltnejo tableto celo.
Before you start taking this medicine your doctor will check to make sure this medicine is safe for you and that it will help you. 
Preden boste začeli jemati to zdravilo, bo vaš zdravnik preveril, da se bo prepričal, ali je to zdravilo za vas varno in ali vam bo pomagalo.
Intuniv must be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. 
Zdravilo Intuniv se mora uporabljati kot del vsestranskega programa zdravljenja ADHD, ki praviloma vključuje psihološke, edukacijske in socialne ukrepe.
• you are allergic to guanfacine or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na gvanfacin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Patients should be advised to drink plenty of fluid. 
Bolnikom je treba svetovati, naj uživajo veliko tekočine.
The blisters are contained in cardboard cartons. 
Pretisni omoti so shranjeni v kartonskih škatlah.
Intuniv with food, drinks and alcohol 
Zdravilo Intuniv skupaj s hrano, pijačo in alkoholom
Due to variability in interaction effect, further dose titration may be needed (see above). 
Zaradi variabilnosti učinka interakcije bo mogoče potrebno nadaljnje titriranje odmerka (glejte zgoraj).
Guanfacine is not dialysable in clinically significant amounts (2.4%). 
Gvanfacin se ne dializira v klinično pomembnih količinah (2,4 %).
• sleeping more than normal (hypersomnia) 
• spite več, kot je normalno (hipersomnija),
The medicine is given as part of a treatment programme, which usually includes the following: 
Zdravilo se uporablja v okviru terapevtskega programa, ki navadno vključuje:
Depending on how you respond to treatment your doctor may increase your dose more slowly. 
Odvisno od vašega odziva na zdravljenje vam lahko zdravnik zvečuje odmerek še počasneje.
If this happens do not drive, cycle, use any tools or machines or participate in activities that could cause injury until you know how this medicine affects you. 
Če se to zgodi, ne vozite, ne kolesarite, ne uporabljajte orodja ali strojev in ne sodelujte pri dejavnostih, pri katerih bi lahko poškodovali sebe ali druge, dokler ne boste spoznali, kako to zdravilo vpliva na vas.
Studies SPD503-301 and SPD503-304 were 8 and 9 weeks in duration, respectively, both conducted in the United States. 
Študiji SPD503-301 in SPD503-304 sta trajali 8 oziroma 9 tednov, obe so opravili v Združenih državah.
• Swallow the tablet whole with a drink of water or other liquid (but not grapefruit juice). 
• Tableto pogoltnite célo s kozarcem vode ali kake druge pijače (ne pa soka grenivke).
In particular, tell your doctor or pharmacist if you are taking any of the following types of medicines: 
Zdravniku ali farmacevtu še zlasti povejte, če jemljete kakšno od naslednjih vrst zdravil:
• medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics) 
• zdravila za težave z duševnim zdravjem (benzodiazepini, barbiturati in antipsihotiki);
Your doctor will routinely monitor you to see how this medicine affects you. 
Zdravnik vas bo redno spremljal, da bo videl, kako to zdravilo vpliva na vas.
These patients should receive further cardiac evaluation based on clinical judgement (see section 4.8). 
Pri teh bolnikih je potrebna nadaljnja kardiološka obravnava na podlagi klinične presoje (glejte poglavje 4.8).
Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician. 
Bolnike, pri katerih se med zdravljenjem zaradi ADHD pojavijo samomorilne misli ali samomorilno vedenje, mora nemudoma pregledati njihov zdravnik.
The dose may be adjusted in increments of not more than 1 mg per week. 
Odmerek lahko prilagajamo v korakih, ki ne smejo biti večji od 1 mg na teden.
This is because Intuniv and some other medicines can affect each other. 
Zdravilo Intuniv in nekatera druga zdravila namreč lahko vplivajo drugo na drugega.
The elimination half-life of guanfacine is approximately 18 hours. 
Razpolovni čas odstranjevanja gvanfacina iz telesa je približno 18 ur.
Monitoring during titration 
Spremljanje med titriranjem
As part of your treatment your doctor will closely monitor how Intuniv is affecting you during initial dosing and/or dose adjustments. 
V okviru vašega zdravljenja bo zdravnik skrbno spremljal, kako zdravilo Intuniv vpliva na vas med začetnim odmerjanjem in/ali prilagoditvami odmerka,.
• changes in liver blood test results (increased alanine aminotransferase) 
• spremembe rezultatov jetrnih krvnih preskusov (zvišana alanin aminotransferaza),
Difference from placebo (95%CI) 
Razlika od placeba (95 % CI)
All drug-drug interaction studies have been performed in adults, however, the outcome is expected to be similar in the indicated paediatric age range. 
Vse študije interakcij med zdravili so opravili pri odraslih, vendar v navedenem pediatričnem starostnem razponu pričakujemo podoben rezultat.
• sit still 
• sedijo pri miru;
The mode of action of guanfacine in ADHD is not fully established. 
Način delovanja gvanfacina pri ADHD ni popolnoma pojasnjen.
Do not use this medicine if the tablets or blister pack look damaged. 
Ne uporabljajte tega zdravila, če so tablete ali pretisni omot videti poškodovani.
Fainting has also been reported but is not a common effect. 
Poročali so tudi o omedlevici, vendar to ni pogosto.
Management of Intuniv overdose should include monitoring for and treatment of these signs and symptoms. 
Zdravljenje prevelikega odmerjanja zdravila Intuniv mora vključevati spremljanje in zdravljenje teh znakov in simptomov.
If you feel unwell in any way while you are taking your medicine please tell an adult straight away. 
Če se na kakršen koli način slabo počutite, tačas ko jemljete to zdravilo, to takoj povejte kakemu odraslemu.
Systemic exposure to guanfacine is similar for men and women given the same mg/kg dose. 
Sistemska izpostavljenost gvanfacinu je podobna pri moških in ženskah, ki prejmejo enak odmerek v mg/kg.
The clinical relevance of this finding is uncertain. 
Klinični pomen te ugotovitve je negotov.
• trouble sleeping (insomnia) or broken sleep (middle insomnia) or nightmares 
• nespečnost (insomnija) ali prekinjeno spanje (srednja nespečnost) ali nočne more,
Guanfacine is moderately bound to plasma proteins (approximately 70%), independent of drug concentration. 
Gvanfacin se zmerno veže na plazemske beljakovine (približno 70 %), neodvisno od koncentracije zdravila.
During the first year of treatment, the patient should be assessed at least every 3 months for: 
Spremljanje med zdravljenjem V prvem letu zdravljenja morate bolnika vsaj vsake 3 mesece ocenjevati glede:
Intuniv is taken once daily either morning or evening. 
Zdravilo Intuniv se jemlje enkrat na dan, bodisi zjutraj bodisi zvečer.
ADHD with Oppositional Symptoms Study 
Študija ADHD z uporniškimi simptomi
However, individuals may have larger increases than reflected by the mean changes. 
Vendar lahko zvišanje vrednosti pri posameznikih presega povprečne spremembe.
The effect of co-administration with psychostimulants was examined in an add-on study in partial responders to psychostimulants. 
Učinek sočasnega dajanja s psihostimulanti so raziskali v dodatni študiji pri delnih responderjih na psihostimulante.
• medicines for epilepsy such as valproic acid 
• zdravila za epilepsijo, na primer valproično kislino;
The recommended dose titration for children and adolescents is provided below (see tables 1 and 2). 
Priporočeno titriranje odmerkov za otroke in mladostnike je podano v nadaljevanju (glejte preglednici 1 in 2).
Guanfacine is a non-stimulant. 
Gvanfacin ni spodbujevalec.
• medicines that make you sleepy (sedatives) 
• zdravila, ki vas naredijo zaspanega (sedativi);
It is not known if Intuniv will affect your unborn baby. 
Ni znano, ali bo zdravilo Intuniv vplivalo na vašega nerojenega otroka.
The safety and efficacy of guanfacine in adult and the elderly with ADHD has not been established and therefore should not be used in this group. 
Varnost in učinkovitost gvanfacina pri odraslih in starejših bolnikih z ADHD nista bili dokazani, zato se to zdravilo v tej skupini bolnikov ne sme uporabljati.
Syncope may involve risks of falls or accidents, which could result in serious harm (see sections 4.8 and 4.7). 
Sinkopa lahko povzroči nevarnost padcev ali nezgod, lahko z resnimi poškodbami (glejte poglavji 4.8 in 4.7).
Patients should be warned of these possible effects and be advised that if affected, they should avoid these activities (see section 4.4). 
Bolnike moramo opozoriti na te možne učinke in jim svetovati, naj se izogibajo tem dejavnostim, če pri sebi opazijo te učinke (glejte poglavje 4.4).
• your response to treatment, in particular if it makes you sleepy or drowsy 
• vaš odziv na zdravljenje, posebno še, če ste zaradi njega zaspani ali se vam drema;
The clinical relevance is unknown. 
Klinični pomen je neznan.
• you have low or high blood pressure, heart problems or have a family history of heart problems 
• imate nizek ali visok krvni tlak, težave s srcem ali družinsko anamnezo težav s srcem;
Difference from placebo (95%CI) Effect size 
Razlika od placeba (95 % CI) Velikost učinka
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Intuniv is launched all healthcare professionals who are expected to prescribe Intuniv are informed through an information letter on having access to / are provided with the following items: 
MAH bo zagotovil, da bodo po pogovorih in dogovoru s pristojnimi nacionalnimi organi v vseh državah članicah, kjer se trži zdravilo Intuniv, vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Intuniv, obveščeni s spremnim dopisom, ki vsebuje informacije, da imajo dostop do naslednjih dokumentov oziroma prejmejo naslednje dokumente:
Prior to launch of Intuniv in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila Intuniv na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) dogovoriti s pristojnim nacionalnim organom o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini distribucije in vsemi drugimi vidiki programa.
Guanfacine is cleared by the kidneys via filtration and active secretion and the liver. 
Gvanfacin čistijo ledvice s filtracijo in aktivno sekrecijo in jetra.
The following table presents all adverse reactions based on clinical trials and spontaneous reporting. 
V naslednji preglednici so navedeni vsi neželeni učinki iz kliničnih preskušanj in spontanih poročil.
Dose Titration Schedule for Adolescents (Aged 13-17 Years) 
Načrt titriranja odmerka za mladostnike (stare 13-17 let)
The ADHD Rating Scale is a measure of the core symptoms of ADHD. 
Lestvica za ocenjevanje ADHD je merilo najpomembnejših simptomov ADHD.
The following serious side effects have been reported. 
Pogosto so poročali o naslednjih resnih neželenih učinkih.
Patients/caregivers should be instructed not to discontinue guanfacine without consulting their physician. 
Bolnike/skrbnike je treba poučiti, naj ne prekinejo jemanja gvanfacina, ne da bi se prej posvetovali s svojim zdravnikom.
• your blood pressure and heart rate and other checks on your heart if appropriate 
• vaš krvni tlak in srčni utrip in druge preiskave srca, če je primerno;
Due to lack of proper toxicokinetic data, comparison to human clinical exposure was not possible. 
Ker ustreznih toksikokinetičnih podatkov ni na voljo, primerjava s klinično izpostavljenostjo pri ljudeh ni bila možna.
Guanfacine is a selective alpha2A-adrenergic receptor agonist in that it has 15-20 times higher affinity for this receptor subtype than for the alpha2B or alpha2C subtypes. 
Gvanfacin je selektiven agonist adrenergičnih receptorjev alfa2A, saj ima 15-20-krat večjo afiniteto za to podvrsto receptorjev kot za podvrsto alfa2B ali alfa2C.
No age differences were observed with respect to response to the ADHD-RS-IV. 
Glede odziva na ADHD-RS-IV niso opazili nikakršnih starostnih razlik.
Hypotension, bradycardia and syncope 
Hipotenzija, bradikardija in sinkopa
• Your daily dose will be between 1 and 7 mg depending on your age and how you respond to Intuniv, but not more that 7 mg. 
• Vaš dnevni odmerek bo med 1 in 7 mg, odvisno od vaše starosti in odziva na zdravilo Intuniv, ne bo pa presegel 7 mg.
• It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast). 
• Lahko ga jemljete s hrano ali brez nje, ne pa z mastno hrano (npr. z mastnim zajtrkom).
While you are taking this medicine your doctor will repeat these checks weekly during initial dosing, after dose adjustments, at least every 3 months for the first year and then at least twice a year. 
Med jemanjem tega zdravila bo zdravnik ponavljal te preiskave vsak teden med začetnim odmerjanjem, po prilagoditvah odmerka, prvo leto vsaj vsake 3 mesece, pozneje pa vsaj dvakrat na leto.
Shire Pharmaceuticals Ireland Limited (as MA Logo) 
Shire Pharmaceuticals Ireland Limited (kot logotip imetnika dovoljenja)
Guanfacine is an in vitro inhibitor of MATE1 and the clinical relevance of MATE1 inhibition cannot be excluded. 
Gvanfacin je in vitro zaviralec MATE1 in kliničnega pomena zaviranja MATE1 ni mogoče izključiti.
• Checklist prior to initiating treatment with Intuniv to identify patients at risk for serious undesirable effects 
• kontrolni seznam pred uvedbo zdravljenja z zdravilom Intuniv za prepoznavanje bolnikov, pri katerih obstajajo tveganja za pojav resnih neželenih učinkov;
This finding has no known clinical relevance. 
Ta ugotovitev nima znanega kliničnega pomena.
The results with respect to the primary endpoint study are presented in Table 5. 
Rezultati študije primarnega končnega stanja so povzeti v preglednici 5.
• Do not break, crush or chew the tablet; this will affect how the tablet works. 
• Tablete ne zlomite, zdrobite ali žvečite; to bi vplivalo na način delovanja tablete.
Length of treatment 
Trajanje zdravljenja
The occurrence of somnolence/sedation and hypotension was most prominent in the first few weeks of treatment and diminished gradually thereafter. 
Pojavljanje somnolence /sedacije in hipotenzije je bilo najbolj izrazito prvih nekaj tednov zdravljenja, nato se je postopoma zmanjševalo.
The physician who elects to use guanfacine for extended periods (over 12 months) should re-evaluate the usefulness of guanfacine every 3 months for the first year and then at least yearly based on clinical judgement (see section 4.4), and consider trial periods off medication to assess the patient's functioning without pharmacotherapy, preferably during times of school holidays. 
Zdravnik, ki se odloči za dolgotrajno uporabo gvanfacina (več kot 12 mesecev), mora ponovno ocenjevati koristnost gvanfacina prvo leto vsake 3 mesece, nato pa vsaj enkrat na leto na podlagi klinične presoje (glejte poglavje 4.4), in pretehtati možnost poskusnih obdobij brez zdravila, da se oceni bolnikovo funkcioniranje brez farmakoterapije, po možnosti v času šolskih počitnic.
• you suffer from any other psychiatric conditions 
• imate kakšno drugo duševno bolezen.