FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Studies SPD503-301 and SPD503-304 were 8 and 9 weeks in duration, respectively, both conducted in the United States.
Slovenian: Študiji SPD503-301 in SPD503-304 sta trajali 8 oziroma 9 tednov, obe so opravili v Združenih državah.
English: • Swallow the tablet whole with a drink of water or other liquid (but not grapefruit juice).
Slovenian: • Tableto pogoltnite célo s kozarcem vode ali kake druge pijače (ne pa soka grenivke).
English: In particular, tell your doctor or pharmacist if you are taking any of the following types of medicines:
Slovenian: Zdravniku ali farmacevtu še zlasti povejte, če jemljete kakšno od naslednjih vrst zdravil:
English: • medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics)
Slovenian: • zdravila za težave z duševnim zdravjem (benzodiazepini, barbiturati in antipsihotiki);
English: Your doctor will routinely monitor you to see how this medicine affects you.
Slovenian: Zdravnik vas bo redno spremljal, da bo videl, kako to zdravilo vpliva na vas.
English: These patients should receive further cardiac evaluation based on clinical judgement (see section 4.8).
Slovenian: Pri teh bolnikih je potrebna nadaljnja kardiološka obravnava na podlagi klinične presoje (glejte poglavje 4.8).
English: Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician.
Slovenian: Bolnike, pri katerih se med zdravljenjem zaradi ADHD pojavijo samomorilne misli ali samomorilno vedenje, mora nemudoma pregledati njihov zdravnik.
English: The dose may be adjusted in increments of not more than 1 mg per week.
Slovenian: Odmerek lahko prilagajamo v korakih, ki ne smejo biti večji od 1 mg na teden.
English: This is because Intuniv and some other medicines can affect each other.
Slovenian: Zdravilo Intuniv in nekatera druga zdravila namreč lahko vplivajo drugo na drugega.
English: The elimination half-life of guanfacine is approximately 18 hours.
Slovenian: Razpolovni čas odstranjevanja gvanfacina iz telesa je približno 18 ur.
English: Monitoring during titration
Slovenian: Spremljanje med titriranjem
English: As part of your treatment your doctor will closely monitor how Intuniv is affecting you during initial dosing and/or dose adjustments.
Slovenian: V okviru vašega zdravljenja bo zdravnik skrbno spremljal, kako zdravilo Intuniv vpliva na vas med začetnim odmerjanjem in/ali prilagoditvami odmerka,.
English: • changes in liver blood test results (increased alanine aminotransferase)
Slovenian: • spremembe rezultatov jetrnih krvnih preskusov (zvišana alanin aminotransferaza),
English: Difference from placebo (95%CI)
Slovenian: Razlika od placeba (95 % CI)
English: All drug-drug interaction studies have been performed in adults, however, the outcome is expected to be similar in the indicated paediatric age range.
Slovenian: Vse študije interakcij med zdravili so opravili pri odraslih, vendar v navedenem pediatričnem starostnem razponu pričakujemo podoben rezultat.
English: • sit still
Slovenian: • sedijo pri miru;
English: The mode of action of guanfacine in ADHD is not fully established.
Slovenian: Način delovanja gvanfacina pri ADHD ni popolnoma pojasnjen.
English: Do not use this medicine if the tablets or blister pack look damaged.
Slovenian: Ne uporabljajte tega zdravila, če so tablete ali pretisni omot videti poškodovani.
English: Fainting has also been reported but is not a common effect.
Slovenian: Poročali so tudi o omedlevici, vendar to ni pogosto.
English: Management of Intuniv overdose should include monitoring for and treatment of these signs and symptoms.
Slovenian: Zdravljenje prevelikega odmerjanja zdravila Intuniv mora vključevati spremljanje in zdravljenje teh znakov in simptomov.
English: If you feel unwell in any way while you are taking your medicine please tell an adult straight away.
Slovenian: Če se na kakršen koli način slabo počutite, tačas ko jemljete to zdravilo, to takoj povejte kakemu odraslemu.
English: Systemic exposure to guanfacine is similar for men and women given the same mg/kg dose.
Slovenian: Sistemska izpostavljenost gvanfacinu je podobna pri moških in ženskah, ki prejmejo enak odmerek v mg/kg.
English: The clinical relevance of this finding is uncertain.
Slovenian: Klinični pomen te ugotovitve je negotov.
English: • trouble sleeping (insomnia) or broken sleep (middle insomnia) or nightmares
Slovenian: • nespečnost (insomnija) ali prekinjeno spanje (srednja nespečnost) ali nočne more,
English: Guanfacine is moderately bound to plasma proteins (approximately 70%), independent of drug concentration.
Slovenian: Gvanfacin se zmerno veže na plazemske beljakovine (približno 70 %), neodvisno od koncentracije zdravila.
English: During the first year of treatment, the patient should be assessed at least every 3 months for:
Slovenian: Spremljanje med zdravljenjem V prvem letu zdravljenja morate bolnika vsaj vsake 3 mesece ocenjevati glede:
English: Intuniv is taken once daily either morning or evening.
Slovenian: Zdravilo Intuniv se jemlje enkrat na dan, bodisi zjutraj bodisi zvečer.
English: ADHD with Oppositional Symptoms Study
Slovenian: Študija ADHD z uporniškimi simptomi
English: However, individuals may have larger increases than reflected by the mean changes.
Slovenian: Vendar lahko zvišanje vrednosti pri posameznikih presega povprečne spremembe.
English: The effect of co-administration with psychostimulants was examined in an add-on study in partial responders to psychostimulants.
Slovenian: Učinek sočasnega dajanja s psihostimulanti so raziskali v dodatni študiji pri delnih responderjih na psihostimulante.
English: • medicines for epilepsy such as valproic acid
Slovenian: • zdravila za epilepsijo, na primer valproično kislino;
English: The recommended dose titration for children and adolescents is provided below (see tables 1 and 2).
Slovenian: Priporočeno titriranje odmerkov za otroke in mladostnike je podano v nadaljevanju (glejte preglednici 1 in 2).
English: Guanfacine is a non-stimulant.
Slovenian: Gvanfacin ni spodbujevalec.
English: • medicines that make you sleepy (sedatives)
Slovenian: • zdravila, ki vas naredijo zaspanega (sedativi);
English: It is not known if Intuniv will affect your unborn baby.
Slovenian: Ni znano, ali bo zdravilo Intuniv vplivalo na vašega nerojenega otroka.
English: 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.
Slovenian: 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.
English: Syncope may involve risks of falls or accidents, which could result in serious harm (see sections 4.8 and 4.7).
Slovenian: Sinkopa lahko povzroči nevarnost padcev ali nezgod, lahko z resnimi poškodbami (glejte poglavji 4.8 in 4.7).
English: Patients should be warned of these possible effects and be advised that if affected, they should avoid these activities (see section 4.4).
Slovenian: 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).
English: • your response to treatment, in particular if it makes you sleepy or drowsy
Slovenian: • vaš odziv na zdravljenje, posebno še, če ste zaradi njega zaspani ali se vam drema;
English: The clinical relevance is unknown.
Slovenian: Klinični pomen je neznan.
English: • you have low or high blood pressure, heart problems or have a family history of heart problems
Slovenian: • imate nizek ali visok krvni tlak, težave s srcem ali družinsko anamnezo težav s srcem;
English: Difference from placebo (95%CI) Effect size
Slovenian: Razlika od placeba (95 % CI) Velikost učinka
English: 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:
Slovenian: 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:
English: 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.
Slovenian: 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.
English: Guanfacine is cleared by the kidneys via filtration and active secretion and the liver.
Slovenian: Gvanfacin čistijo ledvice s filtracijo in aktivno sekrecijo in jetra.
English: The following table presents all adverse reactions based on clinical trials and spontaneous reporting.
Slovenian: V naslednji preglednici so navedeni vsi neželeni učinki iz kliničnih preskušanj in spontanih poročil.
English: Dose Titration Schedule for Adolescents (Aged 13-17 Years)
Slovenian: Načrt titriranja odmerka za mladostnike (stare 13-17 let)
English: The ADHD Rating Scale is a measure of the core symptoms of ADHD.
Slovenian: Lestvica za ocenjevanje ADHD je merilo najpomembnejših simptomov ADHD.
English: The following serious side effects have been reported.
Slovenian: Pogosto so poročali o naslednjih resnih neželenih učinkih.
English: Patients/caregivers should be instructed not to discontinue guanfacine without consulting their physician.
Slovenian: Bolnike/skrbnike je treba poučiti, naj ne prekinejo jemanja gvanfacina, ne da bi se prej posvetovali s svojim zdravnikom.
English: • your blood pressure and heart rate and other checks on your heart if appropriate
Slovenian: • vaš krvni tlak in srčni utrip in druge preiskave srca, če je primerno;
English: Due to lack of proper toxicokinetic data, comparison to human clinical exposure was not possible.
Slovenian: Ker ustreznih toksikokinetičnih podatkov ni na voljo, primerjava s klinično izpostavljenostjo pri ljudeh ni bila možna.
English: 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.
Slovenian: Gvanfacin je selektiven agonist adrenergičnih receptorjev alfa2A, saj ima 15-20-krat večjo afiniteto za to podvrsto receptorjev kot za podvrsto alfa2B ali alfa2C.
English: No age differences were observed with respect to response to the ADHD-RS-IV.
Slovenian: Glede odziva na ADHD-RS-IV niso opazili nikakršnih starostnih razlik.
English: Hypotension, bradycardia and syncope
Slovenian: Hipotenzija, bradikardija in sinkopa
English: • 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.
Slovenian: • Vaš dnevni odmerek bo med 1 in 7 mg, odvisno od vaše starosti in odziva na zdravilo Intuniv, ne bo pa presegel 7 mg.
English: • It can be taken with or without food, but do not take it with fatty foods (e.g., high fat breakfast).
Slovenian: • Lahko ga jemljete s hrano ali brez nje, ne pa z mastno hrano (npr. z mastnim zajtrkom).
English: 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.
Slovenian: 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.
English: Shire Pharmaceuticals Ireland Limited (as MA Logo)
Slovenian: Shire Pharmaceuticals Ireland Limited (kot logotip imetnika dovoljenja)
English: Guanfacine is an in vitro inhibitor of MATE1 and the clinical relevance of MATE1 inhibition cannot be excluded.
Slovenian: Gvanfacin je in vitro zaviralec MATE1 in kliničnega pomena zaviranja MATE1 ni mogoče izključiti.
English: • Checklist prior to initiating treatment with Intuniv to identify patients at risk for serious undesirable effects
Slovenian: • kontrolni seznam pred uvedbo zdravljenja z zdravilom Intuniv za prepoznavanje bolnikov, pri katerih obstajajo tveganja za pojav resnih neželenih učinkov;
English: This finding has no known clinical relevance.
Slovenian: Ta ugotovitev nima znanega kliničnega pomena.
English: The results with respect to the primary endpoint study are presented in Table 5.
Slovenian: Rezultati študije primarnega končnega stanja so povzeti v preglednici 5.
English: • Do not break, crush or chew the tablet; this will affect how the tablet works.
Slovenian: • Tablete ne zlomite, zdrobite ali žvečite; to bi vplivalo na način delovanja tablete.
English: Length of treatment
Slovenian: Trajanje zdravljenja
English: The occurrence of somnolence/sedation and hypotension was most prominent in the first few weeks of treatment and diminished gradually thereafter.
Slovenian: Pojavljanje somnolence /sedacije in hipotenzije je bilo najbolj izrazito prvih nekaj tednov zdravljenja, nato se je postopoma zmanjševalo.
English: 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.
Slovenian: 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.
English: • you suffer from any other psychiatric conditions
Slovenian: • imate kakšno drugo duševno bolezen.
English: • unusual heart rhythm (sinus arrhythmia and first-degree arterioventricular block)
Slovenian: • nenavaden srčni ritem (sinusna aritmija in atrioventrikularni blok prve stopnje),
English: Renal excretion is the major elimination pathway (80%) with parent drug accounting for 30% of the urinary radioactivity.
Slovenian: Ledvična sekrecija je najpomembnejša pot izločanja (80 %), pri čemer izhodno zdravilo predstavlja 30 % radioaktivnosti v urinu.
English: Pharmacotherapeutic group: Antihypertensives, antiadrenergic agents, centrally acting ATC code: C02AC02.
Slovenian: Farmakoterapevtska skupina: Antihipertenzivi, antiadrenergiki s centralnim delovanjem; oznaka ATC: C02AC02.
English: Concomitant administration of guanfacine with OCT1 substrates with a similar Tmax (e.g., metformin) may result in increases in Cmax of these medicinal products.
Slovenian: Sočasna uporaba gvanfacina s substrati OCT1 s podobnim Tmax (npr. z metforminom) lahko povzroči povečanje vrednosti Cmax teh zdravil.
English: The mechanism of this interaction is unknown, although both guanfacine and valproic acid are metabolised by glucuronidation, possibly resulting in competitive inhibition.
Slovenian: Mehanizem te interakcije ni znan, čeprav se tako gvanfacin kot valproična kislina presnavljata z glukuronidacijo, kar bi lahko povzročilo kompetitivno inhibicijo.
English: Thorough QT /QTc study
Slovenian: Temeljita študija intervala QT /QTc
English: Sedation and somnolence
Slovenian: Sedacija in somnolenca
English: About ADHD
Slovenian: O ADHD
English: Intuniv should not be used in children under the age of 6 years because efficacy and safety in this patient population has not been studied.
Slovenian: Zdravilo Intuniv se ne sme uporabljati pri otrocih, mlajših od 6 let, ker v tej skupini bolnikov učinkovitosti in varnosti zdravila niso proučevali.
English: This results in a decrease in peripheral vascular resistance and blood pressure, and a reduction in heart rate.
Slovenian: To povzroči zmanjšanje perifernega vaskularnega upora in krvnega tlaka ter zmanjšanje srčne frekvence.
English: The increases in blood pressure were observed in some individuals at the end of the follow up period which ranged between 3 and 26 weeks post final dose (see sections 4.2 and 5.1).
Slovenian: Pri nekaterih posameznikih so izmerili zvišanje krvnega tlaka na koncu obdobja spremljanja, ki se je gibalo med 3 in 26 tedni po zadnjem odmerku (glejte poglavji 4.2 in 5.1).
English: Patients are advised against operating heavy equipment, driving or cycling until they know how they respond to treatment with Intuniv (see section 4.7).
Slovenian: Bolnikom svetujemo, naj ne upravljajo težkih strojev, vozijo avtomobila ali kolesarijo, dokler ne vedo, kako se odzivajo na zdravljenje z zdravilom Intuniv (glejte poglavje 4.7).
English: Treatment must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.
Slovenian: Zdravljenje se mora začeti pod nadzorom ustreznega specialista za otroške in/ali mladostniške vedenjske motnje.
English: • allergic reaction (hypersensitivity)
Slovenian: • alergijska reakcija (preobčutljivost),
English: Checks your doctor will do when you take Intuniv
Slovenian: Preiskave, ki jih bo opravil vaš zdravnik, ko boste jemali zdravilo Intuniv
English: These reductions represent a percentage reduction of 56% vs. 33% for guanfacine vs. placebo, respectively.
Slovenian: Ta zmanjšanja predstavljajo odstotno zmanjšanje za 56 % proti 33 % za gvanfacin proti placebu.
English: If two or more consecutive doses are missed, re-titration is recommended based on the patient's tolerability to guanfacine.
Slovenian: Če bolnik izpusti dva ali več zaporednih odmerkov, je priporočljivo ponovno titriranje na podlagi bolnikovega prenašanja gvanfacina.
English: For all patients, the recommended starting dose is 1 mg of guanfacine, taken orally once a day.
Slovenian: Za vse bolnike je priporočeni začetni odmerek 1 mg gvanfacina, ki ga jemljejo peroralno enkrat na dan.
English: There is no evidence of any impact of ethnicity on the pharmacokinetics of Intuniv.
Slovenian: Ni dokazov, da bi etnični izvor kakor koli vplival na farmakokinetiko zdravila Intuniv.
English: Patients should be advised that somnolence and sedation can occur, particularly early in treatment or with dose increases.
Slovenian: Bolnikom morate svetovati, da se lahko pojavita somnolenca in sedacija, posebno v začetku zdravljenja ali pri zvečanjih odmerka.
English: • medicines that can affect the way Intuniv is eliminated by the liver (please see table below)
Slovenian: • zdravila, ki lahko vplivajo na način, na katerega jetra izločajo zdravilo Intuniv (oglejte si preglednico v nadaljevanju):
English: In case of concomitant use of strong and moderate CYP3A inhibitors, a 50% reduction of the guanfacine dose is recommended.
Slovenian: V primeru sočasne uporabe močnih in zmernih zaviralcev CYP3A je priporočljivo 50-odstotno zmanjšanje odmerka gvanfacina.
English: The primary efficacy assessment was the ADHD-RS-IV total score.
Slovenian: Ocena primarne učinkovitosti je bila skupna ocena ADHD-RS-IV.
English: Male fertility was affected at 8 mg/kg/day, the lowest dose tested, equivalent of 10.8 times the maximum recommended human dose of 0.12 mg/kg on a mg/m basis.
Slovenian: Plodnost samcev je bila prizadeta pri 8 mg/kg/dan, kar je bil najmanjši preskušani odmerek, ki je bil 10,8-krat večji od največjega priporočenega odmerka za človeka v mg/kg, ki je 0,12 mg/kg.
English: The pharmacokinetics of guanfacine is similar in children (aged 6 to 12) and adolescents (aged 13 to 17) ADHD patients, and healthy adult volunteers.
Slovenian: Farmakokinetika gvanfacina je podobna pri otrocih (starih 6 do 12 let) in mladostnikih (starih 13 do 17 let) z ADHD in zdravih odraslih prostovoljcih.
English: Intuniv should not be administered with high fat meals due to increased exposure, as it has been shown that high fat meals have a significant effect on the absorption of guanfacine.
Slovenian: Zdravila Intuniv ne smemo dajati skupaj z zelo mastnimi obroki zaradi zvečane izpostavljenosti, saj so dokazali, da zelo mastni obroki pomembno vplivajo na absorpcijo gvanfacina.
English: • Do not take this medicine with fatty foods (e.g., high fat breakfast), as it may affect the way this medicine works.
Slovenian: • Ne jemljite tega zdravila z obroki hrane, ki vsebujejo veliko maščob (na primer mastnim zajtrkom), ker maščobe v hrani lahko vplivajo na način delovanja tega zdravila.
English: Dose reduction may be required in patients with different degrees of hepatic impairment.
Slovenian: Pri bolnikih z različnimi stopnjami okvare jeter utegne biti potrebno zmanjšanje odmerka.
English: Your treatment will start under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.
Slovenian: Vaše zdravljenje se bo začelo pod nadzorom ustreznega specialista za otroške in/ali mladostniške vedenjske motnje.
English: Guanfacine showed embryo foetal developmental toxicity in mice and rats (NOAEL 0.5 mg/kg/day) and in rabbits (NOAEL 3.0 mg/kg/day) in the presence of maternal toxicity.
Slovenian: Gvanfacin je kazal toksičnost za razvoj zarodkov in plodov pri miših in podganah (NOAEL 0,5 mg/kg/dan) in pri kuncih (NOAEL 3,0 mg/kg/dan) v prisotnosti toksičnosti za mater.
English: If you take more Intuniv than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Intuniv, kot bi smeli, se takoj posvetujte z zdravnikom ali odidite v bolnišnico.
English: It may have a moderate to severe influence on the ability to drive, use machines or cycling.
Slovenian: Zdravilo Intuniv lahko zmerno do močno vpliva na sposobnost vožnje, upravljanja s stroji ali kolesarjenja.
English: Active renal secretion is mediated via OCT2 transporter.
Slovenian: Aktivno ledvično sekrecijo posreduje prenašalec OCT2.
English: Guanfacine is a known antihypertensive agent.
Slovenian: Gvanfacin je znana antihipertenzivna učinkovina.
English: This was a double-blind, randomised, placebo-controlled, dose-optimisation study, 9-weeks in duration conducted in the United States and Canada.
Slovenian: To je bila dvojno slepa, randomizirana, s placebom kontrolirana študija optimizacije odmerka, trajala je 9 tednov in bila opravljena v Združenih državah in Kanadi.
English: Bradycardia occurred in 1.5%, hypotension in 3.2% and syncope occurred in 0.7% of all guanfacine-treated patients.
Slovenian: Bradikardija se je pojavila pri 1,5 %, hipotenzija pri 3,2 % in sinkopa pri 0,7 % vseh bolnikov, zdravljenih z gvanfacinom.
English: Adolescents weighing 58.5 kg and above may be titrated to a 7 mg/day dose after the subject has completed a minimum of 1 week of therapy on a 6 mg/day dose and the physician has performed a thorough review of the subject's tolerability and efficacy.
Slovenian: Mladostnike, ki tehtajo 58,5 kg ali več, lahko titriramo na odmerek 7 mg/dan, potem ko je bolnik dokončal vsaj 1 teden zdravljenja z odmerkom 6 mg/dan in je zdravnik natančno pregledal bolnikovo prenašanje zdravila in učinkovitost zdravila pri njem.