natgillin/translations-raw huggingface dataset:
Only safety data were collected in this study; no new safety signals were identified.
V tej študiji so bili zbrani le podatki o varnosti; novih učinkov, povezanih z varnostjo, niso ugotovili.
After 4 weeks:
Po 4 tednih:
Your doctor will discuss with you the risks and benefits of using this medicine in these situations.
Zdravnik se bo pogovoril z vami o tveganjih in koristih uporabe tega zdravila v takih situacijah.
If this happens to you, do not drive or use machines.
Če se vam to zgodi, ne smete voziti in upravljati s stroji.
The capsules can be taken either with or without food.
Kapsule se lahko jemljejo s hrano ali brez nje.
• abnormally frequent daytime urination
• nenormalno pogosto dnevno uriniranje
However, some side effects may be serious and require treatment.
Nekateri neželeni učinki pa so lahko resni in zahtevajo zdravljenje.
(syncope), fall
(sinkopa), padci
Children and adolescents NUEDEXTA should not be used in children and adolescents below the age of 18 years.
Otroci in mladostniki Zdravilo NUEDEXTA se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Subjects were 25 to 80 years of age with a mean age of approximately 51 years.
Preskušanci so bili stari od 25 do 80 let, s povprečno starostjo približno 51 let.
This medicine may cause changes in heart rhythm.
To zdravilo lahko povzroči spremembe srčnega ritma.
• you have a tendency to have falls.
• ste nagnjeni k padcem.
Do not stop taking this medicine without speaking to your doctor first, even if you begin to feel better.
Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali z zdravnikom, tudi če se počutite bolje.
Furthermore, educational material for HCPs should provide information on the following safety concerns and on the actions needed to reduce the risks:
Poleg tega bo izobraževalni material zdravstvenim delavcem zagotovil informacije o naslednjih varnostnih zadržkih in o ukrepih, ki so potrebni za zmanjševanje tveganj:
• Pivotal study (07-AVR-123)
• Ključna študija (07-AVR-123)
Clinical studies did not include a sufficient number of patients aged ≥65 years to conclusively determine whether they respond differently in terms of efficacy and safety.
Klinične študije niso vključile zadostnega števila bolnikov, starih ≥ 65 let, da bi lahko zagotovo potrdili, ali se odzivajo drugače glede na učinkovitost in varnost.
• Allergic reactions
• alergijskih reakcijah;
• Weeks 2-4 (day 8-28):
• 2.-4. teden (8.-28. dan):
Regardless of which strength of NUEDEXTA has been prescribed to you: • continue the treatment with: two capsules per day (one capsule every 12 hours).
Ne glede na to, katera jakost zdravila NUEDEXTA vam je bila predpisana: • nadaljujte zdravljenje z: dvema kapsulama na dan (ena kapsula na vsakih 12 ur).
Depending on your response to the treatment, your doctor may either decide:
Glede na vaš odziv na zdravljenje, se bo zdravnik odločil:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree an educational programme with the National Competent Authority.
Pred uvedbo na trg v vsaki državi članici se bo imetnik dovoljenja za promet s pristojnim nacionalnim organom dogovoril o izobraževalnem programu.
This medicine may cause dizziness and your doctor might need to discuss appropriate precautions to reduce the risk of falls.
To zdravilo lahko povzroči omotico, zato se bo vaš zdravnik morda želel pogovoriti o primernih previdnostnih ukrepih za zmanjšanje tveganja za padce;
A review of the patient's current medicines is an essential part of the evaluation of patients for whom treatment with NUEDEXTA is proposed.
Pregled trenutnih bolnikovih zdravil je ključen del ocene bolnikov, za katere se predlaga zdravljenje z zdravilom NUEDEXTA.
Dose increase, if warranted, should be undertaken with caution in these patients.
Povečanje odmerka, kjer je upravičeno, je treba pri teh bolnikih uvesti previdno.
Approximately 74% were Caucasian, 4% were Black, 1% were Asian and 19% were of Hispanic origin.
Približno 74 % preskušancev je bilo kavkazijskega porekla, 4 % temnopoltih, 1 % jih je bil azijskega in 19 % hispanskega porekla.
The capsules should be taken orally at about the same time each day.
Kapsule se smejo uporabljati samo peroralno, ob približno istem času vsak dan.
Adverse reactions observed with this medicine may occur more often or may worsen and your doctor may perform some test and monitor you more closely.
Neželene reakcije, ki so jih opazili pri uporabi tega zdravila, se lahko pojavijo pogosteje ali se poslabšajo, zato bo vaš zdravnik morda opravil teste in vas podrobneje spremljal.
Treatment of hypotension and of other signs and symptoms should be directed at symptomatic and supportive measures.
Zdravljenje hipotenzije in drugih znakov ter simptomov mora biti usmerjeno na simptomatske in podporne ukrepe.
Squeeze and hold at tabs above and below () Pull out card to the right ( )
Za odvijanje kapsul iz embalaže: stisnite in držite na jezičkih zgoraj in spodaj (); izvlecite kartico na desno stran ( ).
NMDA receptor antagonists (memantine)
Antagonisti receptorjev NMDA (memantin)
• Studies to Assess Cardiac Effects
• Študije za oceno učinkov na srce
• you have problems with your liver or kidney.
• imate težave z jetri ali ledvicami.
• you have had at any time a serious condition called “serotonin syndrome”, which can be caused by certain medicines e.g. antidepressants.
• ste kadar koli imeli resno bolezen, imenovano “serotoninski sindrom”, ki ga lahko povzročijo določena zdravila, npr. antidepresivi.
The patient alert card should be provided to all patients with instructions to carry it on them at all times.
Kartica z opozorili za bolnika mora biti dana vsem bolnikom z navodilom, naj jo imajo ves čas pri sebi.
These may be a sign of a serious condition called “serotonin syndrome”.
To so lahko znaki resne bolezni, imenovane “serotoninski sindrom”.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
The dose of paroxetine can then be adjusted based on clinical response; however, dosage above 35 mg/day is not recommended.
Potem se lahko odmerek paroksetina prilagodi na podlagi kliničnega odziva, vendar odmerek, večji od 35 mg/dan, ni priporočljiv.
However, cases of dextromethorphan abuse have been reported, predominately in adolescents.
Vendar so poročali o primerih zlorabe dekstrometorfana, predvsem pri mladostnikih.
In the event of inadequate clinical response, see recommended dose titration schedule.
Če je klinični odziv nezadosten, glejte priporočeni razpored titracije odmerka.
The clinical relevance of this observation to drugs that are OCT1 substrates, such as metformin, is unknown.
Klinični pomen te ugotovitve za zdravila, ki so substrati OCT1, npr. za metformin, ni znan.
Other antiarrhythmics with Class I (procainamide) or Class III activities should (if possible) be avoided.
Prav tako se je treba izogibati drugim antiaritmikom z dejavnostjo razreda I (prokainamid) ali razreda III (če je to mogoče).
• The active substances are:
• Zdravilni učinkovini sta:
It is very important to tell your doctor if you are taking any of the medicines listed below, as these medicines should never be taken while you are taking NUEDEXTA:
Zelo pomembno je, da svojega zdravnika obvestite, če jemljete katero koli od spodaj naštetih zdravil,saj se teh zdravil ne sme jemati, ko jemljete zdravilo NUEDEXTA:
• you or a family member currently have or have ever had any heart disease or problems.
• imate vi ali vaš družinski član oz. če ste imeli vi ali vaš družinski član kakršno koli srčno bolezen ali težave s srcem.
In addition it shows affinity for the serotonin transporter (SERT) and for the 5-HT1B/D receptor.
Poleg tega je pokazal afiniteto za prenašalec serotonina (SERT) in receptor 5-HT1B/D.
In case a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Če bolnik pozabi vzeti odmerek, ne sme vzeti dodatnega odmerka, ampak mora vzeti naslednji predpisani odmerek ob običajnem času.
Stopping treatment may cause your symptoms to return.
Prenehanje zdravljenja lahko povzroči ponoven nastop vaših simptomov.
Methods as to acidify the urine and dialysis are of no demonstrated benefit.
Metode z zakisanjem urina in dializo niso pokazale nobene koristi.
No pharmacodynamic interactions were apparent.
Opazili niso nobenih očitnih farmakodinamičnih interakcij.
If you have certain heart problems or are currently taking certain other medicines, NUEDEXTA may not be appropriate for you, or your doctor may want to monitor your heart activity when you start NUEDEXTA.
Če imate določene težave s srcem ali če trenutno jemljete določena druga zdravila, zdravilo NUEDEXTA morda ne bo primerno za vas ali pa bo vaš zdravnik morda želel spremljati delovanje vašega srca, ko boste začeli uporabljati zdravilo NUEDEXTA;
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, or if you are not using reliable contraception, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev oziroma če ne uporabljate zanesljive metode kontracepcije, se posvetujte z zdravnikom, preden vzamete to zdravilo.
A list of all other side effects is provided below:
Seznam vseh ostalih neželenih učinkov se nahaja spodaj:
Your doctor will decide if you should take this medicine while breast-feeding.
Vaš zdravnik se bo odločil, ali lahko uporabljate to zdravilo med dojenjem.
NUEDEXTA is a combination of two active substances:
Zdravilo NUEDEXTA je kombinacija dveh zdravilnih učinkovin:
Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicine or NUEDEXTA.
Zdravnik vas bo natančno spremljal glede neželenih učinkov in/ali bo morda moral prilagoditi odmerek drugega zdravila ali zdravila NUEDEXTA.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
• For the first seven days of treatment: one capsule per day, taken in the morning.
• v prvih sedmih dneh zdravljenja: eno kapsulo na dan, ki jo vzamete zjutraj;
• if you have a heart problem called “complete heart block” or “long QT syndrome” or have had a problem with your heart called “torsades de pointes”.
• če imate težave s srcem, imenovane „popolni srčni blok“ ali „sindrom dolgega intervala QT“ ali pa ste imeli težave s srcem, imenovane „torsades de pointes“;
The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where Nuedexta is marketed, at launch and after launch, all healthcare professionals who are expected to prescribe Nuedexta are provided with the following items:
Imetnik dovoljenja za promet bo zagotovil, da bodo po razpravi in v soglasju z nacionalnimi pristojnimi organi v vsaki državi članici, kjer se bo zdravilo Nuedexta tržilo, ob uvedbi na trg in po uvedbi na trg vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Nuedexta, prejeli naslednje:
Pharmacotherapeutic group: Other nervous system drugs; ATC code: N07XX59
Farmakoterapevtska skupina: druga zdravila z delovanjem na živčevje; oznaka ATC: N07XX59
Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls.
Uvesti je treba previdnostne ukrepe za zmanjšanje tveganja za padce, predvsem pri bolnikih z motorično okvaro, ki vpliva na hojo, ali padce v anamnezi.
Depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you and monitor you more closely for potential side effects.
Glede na resnost vaših težav bo vaš zdravnik natančno razmislil, ali je to zdravilo primerno za vas, in vas natančneje spremljal glede morebitnih neželenih učinkov;
Non-clinical data reveal no special hazard for a genotoxicity or carcinogenic potential, nor for fertility impairment.
Predklinični podatki ne kažejo posebnega tveganja za genotoksični ali karcinogeni potencial ali za zmanjšano plodnost.
• tamoxifen, used to treat or prevent some cancers
• tamoksifen, ki ga uporabljamo za zdravljenje in preprečevanje nekaterih vrst raka;
• Week 1 (day 1-7):
• 1. teden (1.-7. dan):
In the pre and post-natal developmental study, slight developmental delay was seen in offspring at the mid- and high-doses.
V študiji prenatalnega in postnatalnega razvoja so opazili manjši razvojni zaostanek mladičev pri srednjih in visokih odmerkih.
Do not take NUEDEXTA if you have taken these antidepressants during the last two weeks and allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
Ne vzemite zdravila NUEDEXTA, če ste v zadnjih dveh tednih jemali te antidepresive, in počakajte vsaj 14 dni po prenehanju jemanja zdravila NUEDEXTA, preden začnete z jemanjem MAOI.
• you have a history of drug abuse.
• v vaši anamnezi obstaja zloraba drog.
The most important effects of acute overdoses are ventricular arrhythmias and hypotension.
Najpomembnejši učinki akutnega prevelikega odmerjanja so ventrikularne aritmije in hipotenzija.
• if you are allergic to dextromethorphan, quinidine or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na dekstrometorfan, kinidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
NUEDEXTA has no or negligible influence on the ability to drive and use machines.
Zdravilo NUEDEXTA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Each blister is packed in a sleeve.
Vsaka plastenka je pakirana v škatlo.
Due to the possibility of dextromethorphan abuse, physicians should evaluate patients for a history of drug abuse, and observe such patients closely for signs of misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behaviour).
Zaradi možnosti zlorabe dekstrometorfana morajo zdravniki pri bolnikih oceniti, ali obstaja zloraba drog v anamnezi, in take bolnike pozorno spremljati za znake napačne uporabe ali zlorabe (npr. razvoj tolerance, povečanje odmerka, vedenje, ki kaže na zasvojenost).
If NUEDEXTA and paroxetine are prescribed concomitantly, the initial dose of paroxetine should be reduced.
Če se sočasno predpiše zdravilo NUEDEXTA in paroksetin, je treba začetni odmerek paroksetina zmanjšati.
When the urine pH is less than 7, about 20% of administered quinidine appears unchanged in the urine, but this fraction drops to as little as 5% when the urine is more alkaline.
Če je pH urina manj kot 7, se približno 20 % danega kinidina pojavi v urinu v nespremenjeni obliki, ta delež pa pade na 5 %, če je urin bolj bazičen.
• excessive muscle stiffness (spasticity)
• prekomerno otrdelost mišic (spastičnost);
• bone fractures (skeletal injury)
• zlomi kosti (poškodbe okostja)
Anticholinergic effects of quinidine
Antiholinergični učinki kinidina
Drug abuse and dependence
Zloraba drog in odvisnost od njih
What NUEDEXTA is and what it is used for
Kaj je zdravilo NUEDEXTA in za kaj ga uporabljamo
It is not known whether the active substances of NUEDEXTA are expressed into human milk.
Ni znano, ali se zdravilne učinkovine zdravila NUEDEXTA izločajo v človeško mleko.
• heart problems, such as slow, fast or irregular heart beat, or altered results during an electrocardiogram (ECG - QT prolongation)
• težave s srcem, npr. počasen, hiter ali nepravilen srčni utrip, ali sprememba rezultatov elektrokardiograma (EKG - podaljšanje intervala QT)
There are several hydroxylated metabolites of quinidine.
Obstaja več hidroksiliranih metabolitov kinidina.
Nuedexta is suitable only for the treatment of PBA, not for other causes of emotional lability.
Zdravilo Nuedexta je primerno samo za zdravljenje PBP, in ne za druge vzroke čustvene labilnosti.
The European Medicines Agency has waived the obligation to submit the results of studies with NUEDEXTA in all subsets of the paediatric population in PBA (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom NUEDEXTA za vse podskupine pediatrične populacije s PBP (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Quinidine clearance is unaffected, although there is an increased volume of distribution that leads to an increase in the elimination half-life.
Na očistek kinidina to ne vpliva, čeprav se pojavi povečan volumen porazdelitve, ki povzroči podaljšanje razpolovnega časa izločanja.
The capsule should be taken orally (by mouth) either with or without food at about the same time each day.
Kapsulo vzamete peroralno (jo pojeste) s hrano ali brez nje in ob približno istem času dneva.
Other hypersensitivity reactions
Druge preobčutljivostne reakcije
When NUEDEXTA is used with other serotoninergic medicines, the risk of “serotonin syndrome” may be increased due to pharmacodynamic interaction.
Če se zdravilo NUEDEXTA uporablja skupaj z drugimi serotoninergičnimi zdravili, se lahko tveganje za „serotoninski sindrom“ poveča zaradi farmakodinamične interakcije.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1.
• loss of appetite (anorexia)
• izguba teka (anoreksija)
Hypokalemia and hypomagnesemia should be corrected prior to initiation of therapy, and serum potassium and serum magnesium levels should be monitored during treatment if clinically indicated.
Hipokaliemijo in hipomagneziemijo je treba popraviti pred začetkom zdravljenja, med zdravljenjem pa je treba spremljati ravni kalija in magnezija v serumu, če je to klinično indicirano.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from NUEDEXTA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom NUEDEXTA, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
No other drug interactions with CYP2D6 substrates have been systematically investigated.
Nobenih drugih interakcij s substrati encima CYP2D6 niso proučevali sistematično.
• increased liver enzymes (GGT, AST, ALT)
• povišana raven jetrnih encimov (GGT, AST, ALT)
• medicines to reduce pain and/or cough, such as codeine and hydrocodone
• zdravila za odpravljanje bolečin in/ali kašlja, npr. kodein in hidrokodon;
Patients should be monitored for worsening clinical condition in myasthenia gravis and other conditions that may be adversely affected by anticholinergic effects.
Bolnike je treba spremljati za poslabšanje kliničnega stanja pri miasteniji gravis in drugih stanj, na katera lahko neželeno vplivajo antiholinergični učinki.
• Cardiac effects (QT prolongation) including pre-existing cardiovascular conditions and clinically significant electrolyte imbalances
• učinkih na srce (podaljševanje intervala QT), vključno z obstoječimi srčno-žilnimi boleznimi in klinično pomembnimi neravnovesji elektrolitov
Likewise, this medicinal product should not be restarted in sensitised patients, because more rapid and more severe thrombocytopenia than the original episode can occur.
Poleg tega se zdravilo ne sme ponovno uvesti pri preobčutljivih bolnikih, saj se lahko pojavi hitrejša in hujša trombocitopenija kot pri prvi epizodi.
Please tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects.
Obvestite svojega zdravnika, če jemljete katero koli od naslednjih zdravil, saj vas bo zdravnik natančno spremljal glede neželenih učinkov:
• From the eighth day of treatment onwards: two capsules per day, one in the morning and one in the evening, 12 hours apart.
• od osmega dne zdravljenja naprej: dve kapsuli na dan, eno vzamete zjutraj, drugo pa zvečer v razmiku 12 ur.
Paroxetine exposure (AUC0-24) increased by 1.7 fold and Cmax increased by 1.5 fold.
Izpostavljenost paroksetinu (AUC0-24) se je povečala za 1,7-krat, Cmax.
Patients should be warned about the potential for CNS-related effects like somnolence, dizziness and syncope or impaired vision (see section 4.8), and advised not to drive or operate machinery if these symptoms occur.
Bolnike je treba opozoriti na morebitne učinke na osrednje živčevje, kot so somnolenca, omotica ter sinkopa ali poslabšan vid (glejte poglavje 4.8), in jim svetovati, naj ne vozijo ali upravljajo strojev, če se pojavijo ti simptomi.
Your doctor will monitor you closely for signs of NUEDEXTA misuse or abuse.
Vaš zdravnik vas bo natančno spremljal za znake napačne uporabe ali zlorabe zdravila NUEDEXTA.
The exact mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown.
Natančni mehanizem, s katerim dekstrometorfan povzroča terapevtske učinke pri bolnikih s psevdobulbarno paralizo, ni znan.
Treatment of dextromethorphan overdose should be directed at symptomatic and supportive measures.
Zdravljenje prevelikega odmerjanja dekstrometorfana mora biti usmerjeno na simptomatske in podporne ukrepe.
Other medicines and NUEDEXTA
Druga zdravila in zdravilo NUEDEXTA
The pharmacokinetics of dextromethorphan/quinidine have not been investigated systematically in elderly subjects (aged >65 years) although such subjects were included in the clinical programme (14% ≥65 years, 2% ≥75 years).
Farmakokinetike dekstrometorfana/kinidina niso sistematično proučevali pri starejših bolnikih (starih > 65 let), čeprav so bili ti preskušanci vključeni v klinični program (14 % ≥ 65 let, 2 % ≥ 75 let).
• Serotonin syndrome
• serotoninskim sindromom;
• excessively slow or shallow breathing (respiratory depression) and/or turning blue.
• prepočasno ali plitko dihanje (respiratorno depresijo) in/ali pomodrelost.
The maximum mean (95% upper confidence bound) difference from placebo after baseline correction was 10.2 (12.6) ms.
Največja povprečna (95-odstotna zgornja meja zaupanja) razlika v primerjavi s placebom po korekciji glede na izhodišče je bila 10,2 (12,6) ms.
Interaction with NUEDEXTA may result in an increased effect on QT interval (see sections 4.4 and 4.5).
Interakcija z zdravilom NUEDEXTA lahko poveča učinek na interval QT (glejte poglavji 4.4 in 4.5).
These are medicines used to treat malaria or heart rhythm problems.
To so zdravila, ki jih uporabljamo za zdravljenje malarije ali težav s srčnim ritmom;
NUEDEXTA can help reduce how often you have episodes of PBA.
Zdravilo NUEDEXTA lahko pomaga zmanjšati pogostnost vaših epizod PBP.
The treatment of cardiac effects (haemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes)) is either immediate cardioversion or immediate overdrive pacing.
Zdravljenje učinkov na srce (hemodinamsko nestabilna polimorfna ventrikularna tahikardija (vključno s torsades de pointes)) vključuje takojšnjo kardioverzijo ali takojšnjo „pospeševalno“ (overdrive) elektrostimulacijo.