natgillin/translations-raw huggingface dataset:
Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Sonata nije utjecala na farmakokinetičke i farmakodinamičke profile digoksina i varfarina, dvije tvari s uskim terapijskom indeksom.
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see section 4.4).
Primjena (čak pri terapijskim dozama) može dovesti do razvoja fizičke ovisnosti: prekid terapije može dovesti do simptoma ustezanja ili povratnog (“rebound”) fenomena (vidjeti dio 4.4).
Should this occur, use of this product should be discontinued.
U slučaju njihove pojave treba prekinuti primjenu ovog lijeka.
Paediatric patients Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3).
Sonata je kontraindicirana kod djece i adolescenata mlađih od 18 godina (vidjeti dio 4.3).
The risk of dependence increases with dose and duration of treatment and is greater with patients having a history of alcohol and medicinal product abuse.
Rizik od ovisnosti raste s dozom i trajanjem liječenja te je veći u bolesnika s anamnezom zloupotrebe alkohola i lijekova.
Metabolism
Metabolizam
Additionally, there was no pharmacokinetic interaction between zaleplon and venlafaxine (extended release).
Pored toga, nije bilo farmakokinetičke interakcije između zaleplona i venlafaksina (s produljenim oslobađanjem).
Follow-up studies indicated that impaired fertility was due to an effect on the female.
Ispitivanja praćenja ukazala su da je plodnost narušena zbog učinka na ženke.
Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC considered that changes to the product information were warranted.
Stoga, uzimajući u obzir dostupne podatke vezane za učinke lijeka na upravljanje vozilima i mentalnu budnost sljedeći dan, PRAC je smatrao da su promjene u informacijama o lijeku opravdane.
Also, because of the increased risk for intentional overdose in patients with depression in general, the quantity of a medicinal product, including zaleplon, prescribed for such patients should be kept to the necessary minimum.
Također, zbog općenito povećanog rizika namjernog predoziranja u bolesnika s depresijom, količina lijeka, uključujući zaleplon, propisanog tim bolesnicima treba biti svedena na nužni minimum.
In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Sonata.
Nadalje, ibuprofen, kao primjer tvari koja mijenja izlučivanje putem bubrega, nije pokazao interakcije sa Sonatom.
Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina.
PHARMACEUTICAL FORM AND CONTENTS 7 hard capsules
OBLIK I SADRŽAJ 7 tvrdih kapsula
Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum recommended dose.
Iako se ponašanja poput vožnje u snu mogu pojaviti uz primjenu samog sedativa-hipnotika pri terapijskim dozama, čini se da primjena alkohola i drugih depresora središnjeg živčanog sustava (SŽS) uz sedative-hipnotike, kao i prekoračenje maksimalne preporučene doze, povećavaju rizik od takvih ponašanja.
visual impairment, diplopia
oštećenje vida, diplopija
If you still have problems sleeping after you have finished your capsules, contact your doctor again.
Ako i nakon što ste potrošili kapsule imate problema sa spavanjem, ponovno se obratite svom liječniku.
You should not take a second dose within a single night.
Ne smijete uzeti drugu dozu u istoj noći.
The elimination half-life of zaleplon is approximately 1 hour.
Poluvijek eliminacije zaleplona je približno 1 sat.
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).
Morate reći svom liječniku ili ljekarniku ako uzimate cimetidin (lijek za želudac) ili eritromicin
Hence, no dose adjustment is required in these patients.
Stoga nije potrebno prilagođavanje doze u tih bolesnika.
What Sonata contains
Što Sonata sadrži
This decreased sleep latency was significantly different from that observed with placebo.
Ovo skraćeno vrijeme do usnivanja znatno se razlikovalo od onog uočenog kod primjene placeba.
At these doses, a significant reduction in the weight of both prostate and testes was apparent in a three month study in prepubescent dogs.
Pri ovim dozama, bilo je vidljivo znatno smanjenje težine prostate i testisa u tromjesečnom ispitivanju na spolno nezrelim psima.
Repeated dose toxicity
Toksičnost ponovljenih doza
Induced vomiting is not recommended.
Ne preporučuje se inducirati povraćanje.
As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Sonata.
S obzirom da primjena nakon jela produljuje vrijeme za postizanje maksimalne koncentracije u plazmi za približno 2 sata, uz Sonatu ili nedugo prije uzimanja Sonate nije dozvoljen unos hrane.
Tolerance
Tolerancija
Amnestic effects may be associated with inappropriate behaviour (see section 4.4).
Učinci amnezije mogu biti povezani s nepriličnim ponašanjem (vidjeti dio 4.4).
• Do not use a second dose of Sonata within a single night.
• Ne uzimajte drugu dozu Sonate u istoj noći.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
The oxidative metabolites are further metabolised by conjugation via glucuronidation.
Oksidativni metaboliti se nakon toga metaboliziraju konjugacijom kroz glukuronidaciju.
Treatment of Sonata overdose is largely supportive.
Liječenje predoziranja Sonatom uvelike je suportivno.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Ako bilo koja nuspojava postane ozbiljna ili ako opazite bilo koju nuspojavu koja nije navedena u ovoj uputi, molimo obavijestite svojeg liječnika ili ljekarnika.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Unutar svake skupine učestalosti, nuspojave su navedene prema sve manjoj ozbiljnosti.
• if you have sleep apnoea syndrome (stopping breathing for short periods while asleep).
• ako imate sindrom apneje u snu (kratkotrajni prekid disanja dok spavate)
6.6 Special precautions for disposal and other handling No special requirements.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Nema posebnih zahtjeva.
However, because both of these compounds have CNS effects, an additive pharmacodynamic effect is possible.
zbog toga što obje ove tvari imaju učinak na središnji živčani sustav, moguć je aditivni farmakodinamički učinak.
The remainder of the urinary recovery consists of minor metabolites.
Ostatak lijeka izlučenog u urinu čine manje važni metaboliti.
Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data are available on Sonata to assess its safety during pregnancy and breastfeeding.
Iako ispitivanja na životinjama nisu pokazala teratogene ili embriotoksične učinke, nema dovoljno dostupnih kliničkih podataka za procjenu sigurnosti primjene Sonate tijekom trudnoće i dojenja.
In patients with moderate impairment and those on dialysis there was a reduction of approximately 23% in peak plasma concentration compared to healthy volunteers.
U bolesnika s umjerenim oštećenjem i onih na dijalizi, vršne koncentracije u plazmi smanjene su za približno 23% u usporedbi sa zdravim dobrovoljcima.
depersonalisation, hallucinations, depression, confusional state, apathy somnambulism
depersonalizacija, halucinacije, depresija, stanje zbunjenosti, apatija somnambulizam
What you need to know before you take Sonata
Što morate znati prije prije nego počnete uzimati Sonatu
Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data)
Rijetke (≥1/10,000 do <1/1,000) Vrlo rijetke (<1/10,000) nepoznate (ne mogu se procjeniti iz dostupnih podataka)
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines the next day.
Sedacija, amnezija, poremećaj koncentracije i poremećaj mišićne funkcije mogu štetno utjecati na sposobnost upravljanja vozilima i rada sa strojevima sljedeći dan.
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma.
Ako uzmete prekomjernu dozu vrlo brzo možete postati pojačano omamljeni, a velike doze vjerojatno mogu dovesti do kome.
There are different doses for people who are 65 or older, and those who have mild to moderate liver problems: 65 or older: Take one 5 mg capsule Mild to moderate liver problems: Take one 5 mg capsule
Doze su drugačije za osobe koje imaju 65 ili više godina i za one koje imaju blage do umjerene probleme s jetrom: 65 godina ili stariji: uzeti jednu kapsulu od 5 mg Blagi do umjereni problemi s jetrom: uzmite jednu kapsulu od 5 mg
Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Sonata at recommended doses in humans.
U cjelini, rezultati nekliničkih ispitivanja ne ukazuju nikakvu značajnu sigurnosnu opasnost od primjene Sonate u ljudi pri preporučenim dozama.
There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose levels in humans have not been determined.
Postoji ograničeno kliničko iskustvo o učincima akutnog predoziranja Sonatom, a razine predoziranja u ljudi nisu utvrđene.
In combination with its subtype selective receptor-binding characteristics, with high selectivity and low affinity for the benzodiazepine type I receptor, these properties are responsible for the overall characteristics of Sonata.
kombinaciji sa svojim karakteristikama selektivnog vezanja za benzodiazepinski podtip receptora i uz visoku selektivnost i nizak afinitet za benzodiazepinski receptor tipa I, ova su svojstva odgovorna za cjelokupne karakteristike Sonate.
PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters.
6.5 Vrsta i sadržaj spremnika PVC / PVDC aluminijsko blister pakiranje sa 7, 10 i 14 kapsula u perforiranim blisterima djeljivim na jedinične doze.
Insomnia that persists or worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient.
Nesanica koja ne prolazi ili se pogoršava nakon kratkotrajnog liječenja zaleplonom može ukazivati na potrebu za ponovnom evaluacijom bolesnika.
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
U liječenju predoziranja bilo kojim lijekom, treba imati na umu da se možda uzelo više tvari.
Specific patient groups
Posebne skupine bolesnika
Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide metabolite.
Pedeset i sedam posto (57%) doze izlučuje se u urinu u obliku 5-okso-zaleplona i njegovog glukuronidnog metabolita, a dodatnih 9% u obliku 5-okso-dezetilzaleplona i njegovog glukuronidnog metabolita.
10 hard capsules
10 tvrdih kapsula
However, there is no clinical experience with the use of flumazenil as an antidote to a Sonata overdose.
Međutim, nema dovoljno kliničkog iskustva o primjeni flumazenila kao antidota kod predoziranja Sonatom.
Do not take any other medicines without asking your doctor or pharmacist first.
Ne uzimajte nikakve druge lijekove bez prethodnog savjetovanja sa svojim liječnikom ili ljekarnikom.
anorexia
anoreksija
Reporting of suspected adverse reactions
Prijavljivanje sumnji na nuspojave
photosensitivity reaction angioedema
reakcija fotoosjetljivosti angioedem
What Sonata is and what it is used for
Što se nalazi u ovoj uputi: Što je Sonata i za što se koristi
While there were no significant findings in relation to zaleplon, a small number of cases have been reported in the post-marketing setting, although mostly in combination with other CNS depressant agents and at doses greater than 10mg.
Nakon stavljanja lijeka na tržište nije bilo značajnih otkrića vezanih za zaleplon, ali prijavljen je mali broj slučajeva, no većinom u kombinaciji s drugim depresorima SŽS-a i u dozama većim od 10 mg.
Therefore, caution is advisable in co-administering cimetidine and Sonata.
Stoga se preporučuje oprez prilikom istodobne primjene cimetidina i Sonate.
All of zaleplon's metabolites are inactive in both animal behavioural models and in vitro activity assays.
Svi metaboliti zaleplona neaktivni su u životinjskim bihevioralnim modelima kao i u in vitro analizama aktivnosti.
On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness.
Kod prekida liječenja može Vam se vratiti izvorna nesanica te možete imati simptome poput promjena raspoloženja, tjeskobe i nemira.
Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Sonata je indicirana za liječenje bolesnika s nesanicom koji imaju poteškoća s usnivanjem.
Sonata's efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
Djelotvornost Sonate dokazana je i u laboratorijskim ispitivanjima spavanja koja su koristila objektivna polisomnografska (PSG) mjerenja sna i u ispitivanjima ambulantnih bolesnika koja su koristila upitnike za bolesnike za procjenu spavanja.
Pre-and postnatal growth of rats was reduced at the maternally toxic dose of 100 mg/kg/day.
Pre- i postnatalni rast štakora bio je smanjen pri maternalnoj toksičnoj dozi od 100 mg/kg/dan.
Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations are reached in approximately 1 hour.
Zaleplon se brzo i gotovo u potpunosti apsorbira nakon peroralne primjene, a vršne koncentracije postižu se za prosječno 1 sat.
Some can cause drowsiness and should not be taken while taking Sonata.
Neki lijekovi mogu uzrokovati omamljenost i ne smiju se uzimati istodobno sa Sonatom.
It may be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and restlessness.
To može biti popraćeno drugim reakcijama koje uključuju promjene raspoloženja, tjeskobu ili poremećaje spavanja i nemir.
Co. Meath
Meath
Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).
Nikad ne konzumirajte alkohol dok se liječite Sonatom (vidjeti „Upozorenja i mjere opreza“).
• There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
• Kada uzimate lijekove za spavanje, postoji mogućnost da ćete doživjeti određenu vrstu privremenog gubitka pamćenja (amneziju) i nedostatak koordinacije.
Dependence
Ovisnost
There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug.
Ne postoji farmakokinetička interakcija između zaleplona i difenhidramina nakon primjene jednokratne doze (10 mg odnosno 50 mg) svakoga lijeka.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „Rok valjanosti“ ili kratice EXP.
In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
U blagim slučajevima, simptomi uključuju omamljenost, mentalnu smetenost i letargiju; u ozbiljnijim slučajevima, simptomi mogu uključivati ataksiju, hipotoniju, hipotenziju, respiratornu depresiju, rijetko komu, a vrlo rijetko smrt.
The value of forced dialysis or haemodialysis in the treatment of over dosage has not been determined.
Nije utvrđena vrijednost forsirane dijalize ili hemodijalize u liječenju predoziranja.
14 hard capsules
14 tvrdih kapsula
Co-administration of Sonata together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Istodobna primjena Sonate zajedno s induktorima CYP3A4, poput rifampicina, karbamazepina i fenobarbitona može rezultirati smanjenjem djelotvornosti zaleplona.
The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea.
Najčešće zabilježene nuspojave na lijek su amnezija, parastezija, somnolencija i dismenoreja.
Do not take Sonata
Nemojte uzimati Sonatu
Amnesia
Amnezija
Carcinogenicity
Karcinogenost
It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Indicirana je samo u slučajevima kad su poremećaji teški, onesposobljavajući ili dovode pojednica u stanje krajnje iscrpljenosti.
Due to the risk to the patient and the community, discontinuation of zaleplon is recommended for patients who report a “sleep-driving” episode.
Zbog rizika za bolesnika i zajednicu, u bolesnika u kojih je zabilježena epizoda “vožnje u snu” preporučuje se prekinuti uzimanje zaleplona.
• If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.
• Ako Vaša nesanica potraje ili se pogorša nakon kratkotrajnog liječenja Sonatom, obratite se svom liječniku.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant increase in benign but not in malignant liver tumors.
Peroralna primjena zaleplona kod miševa tijekom 65 ili 104 uzastopna tjedna pri visokim razinama doze (≥100 mg/kg/dan) izazvala je statistički znatno povećanje broja benignih, no ne i malignih tumora jetre.
Insomnia may represent an underlying physical or psychiatric disorder.
Nesanica može predstavljati podležeći fizički ili psihijatrijski poremećaj.
In line with effects observed with other compounds binding to benzodiazepine receptors, reversible increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral administration of high multiples of the maximum human therapeutic dose.
U skladu s učincima uočenim kod primjene drugih tvari koje se vežu na benzodiazepinske receptore, reverzibilno povećanje težine jetre i nadbubrežnih žlijezda kod štakora i pasa opaženo je samo nakon ponovljene peroralne primjene velikih višekratnika maksimalnih terapijskih doza za ljude.
Infants born to mothers who took benzodiazepine and benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Novorođenčad majki koje su tijekom kasnijih faza trudnoće dugoročno uzimale benzodiazepine i lijekove srodne benzodiazepinima možda su razvila fizičku ovisnost te mogu biti podložna određenom riziku od razvijanja simptoma ustezanja u postnatalnom razdoblju.
Memory and psychomotor impairment
Poremećaj pamćenja i psihomotorni poremećaj
Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Benzodiazepini i lijekovi srodni benzodiazepinima ne preporučuju se kao primarno liječenje psihotične bolesti.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ako Vam je liječnik rekao da ne podnosite neke šećere, prije uzimanja ovog lijeka, obratite se svom liječniku.
Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Raspodjela Zaleplon je lipofilna tvar s volumenom raspodjele od oko 1,4 ± 0,3 l/kg nakon intravenske primjene.
If for compelling medical reasons, the medicinal product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.
Ako su u kasnoj fazi trudnoće ili tijekom poroda zbog opravdanih medicinskih razloga primjenjivane veće doze lijeka, mogu se očekivati učinci na novorođenče kao što su hipotermija, hipotonija i umjerena respiratorna depresija uzrokovani farmakološkim djelovanjem tvari.
Warnings already exist in the zaleplon product information however based on the available information the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure clear information is available for patients and healthcare professionals given the potentially serious consequences of next day psychomotor impairment.
Međutim, temeljem dostupnih informacija PRAC smatra da je pametno u sklopu ovog postupka to još naglasiti u tekstu sažetka opisa svojstava lijeka i upute o lijeku kako bi se osigurala jasnoća informacija za bolesnike i zdravstvene djelatnike, s obzirom na potencijalno ozbiljne posljedice poremećene psihomotorne funkcije sljedeći dan.
If you stop taking Sonata
Ako prestanete uzimati Sonatu
Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately
Zaleplon se podvrgava presistemskom metabolizmu što rezultira apsolutnom bioraspoloživosti od približno 30%.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Učestalost mogućih, dolje navedenih nuspojava definirana je kako slijedi: vrlo često (javlja se u više od 1 na 10 korisnika) često (javlja se u 1 do 10 na 100 korisnika) manje često (javlja se u 1 do 10 na 1 000 korisnika)
No adverse effects on embryofetal development were observed in rabbits.
Kod kunića nisu uočeni štetni učinci na embriofetalni razvoj.
• if you have severe breathing or chest problems.
• ako imate teške probleme s disanjem ili prsnim košem
No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata pharmacokinetics is not altered in such patients.
Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim zatajenjem bubrega jer u tih bolesnika farmakokinetika Sonate nije promijenjena.
• Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
• Sonatu ili bilo koji drugi lijek za spavanje nemojte upotrebljavajti dulje nego
In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and decreased growth and physical development, were observed in the offspring of females treated with doses of ≥7 mg/kg/day that did not elicit maternal toxicity.
Tijekom ispitivanja pre- i postnatalnog razvoja štakora, uočeni su povećan broj mrtvorođene mladunčadi i postnatalni mortalitet, te smanjen rast i fizički razvoj mladunčadi ženki koje su primile doze ≥7 mg/kg/dan koje nisu izazvale toksičnost kod majke.
See also below under Amnesia Eye disorders
Također vidjeti u nastavku pod Amnezija
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 March 1999
Datum prvog odobrenja: 12. ožujka 1999.