FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeated oral administration of zaleplon to rats and dogs elicited increases in liver and adrenal weights; however, these increases occurred at high multiples of the maximum therapeutic dose, were reversible, were not associated with degenerative microscopic changes in liver or adrenal glands, and were consistent with effects in animals with other compounds that bind to benzodiazepine receptors.
Slovenian: Večkratno peroralno dajanje zaleplona podganam in psom je povzročilo povečanje mase jeter in nadledvičnih žlez, vendar pa je to povečanje, ki je nastopilo pri mnogokratnikih največjega terapevtskega odmerka, reverzibilno, ni povezano z degenerativnimi mikroskopskimi spremembami v jetrih in nadledvičnih žlezah in je bilo v skladu z učinki drugih zdravil, ki se vežejo na benzodiazepinske receptorje pri živalih.
English: Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2).
Slovenian: Benzodiazepini in njim podobne snovi, niso indicirani za zdravljenje bolnikov s hudo jetrno insuficienco, saj lahko povzročijo encefalopatijo (glejte poglavje 4.2).
English: It is not recommended that you take Zerene with or immediately after eating a large meal as it may work more slowly.
Slovenian: Odsvetujemo zaužitje zdravila Zerene skupaj z večjim obrokom ali takoj po zaužitju večjega obroka, saj lahko v tem primeru zdravilo deluje počasneje.
English: The increased incidence of benign liver tumors in mice was likely an adaptive event.
Slovenian: Povečana pojavnost benignih jetrnih tumorjev je bila verjetno posledica prilagoditvene reakcije.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
English: Do not store above 30ºC.
Slovenian: Shranjujte pri temperaturi do 30ºC.
English: In this leaflet: What Zerene is and what it is used for
Slovenian: KAJ JE ZDRAVILO ZERENE IN ZA KAJ GA UPORABLJAMO
English: Some can cause drowsiness and should not be taken while taking Zerene.
Slovenian: Nekatera zdravila lahko povzročijo zaspanost in jih ne smete jemati skupaj z zdravilom Zerene.
English: In elderly patients, sleep latency was often significantly decreased with Zerene 5 mg and was consistently decreased with Zerene 10 mg compared with placebo in 2-week studies.
Slovenian: Pri starostnikih se je spalna latenca pogosto bistveno zmanjšala pri uporabi zdravila Zerene 5 mg in dosledno zmanjšala pri uporabi zdravila Zerene 10 mg v primerjavi s placebom v 2-tedenskih raziskavah.
English: Because zaleplon is excreted in the breast milk, Zerene should not be administered to breast-feeding mothers.
Slovenian: Ker se zaleplon izloča v materino mleko, se zdravilo Zerene ne sme dajati doječim materam.
English: Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a history of alcohol or medicinal product abuse.
Slovenian: Benzodiazepine in njim podobne snovi, morate uporabljati zelo previdno pri bolnikih, ki imajo v anamnezi zlorabo alkohola ali zdravila.
English: Zerene contains lactose.
Slovenian: Zdravilo Zerene vsebuje laktozo.
English: 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.
Slovenian: Peroralno dajanje zaleplona mišim v času 65 ali 104 zaporednih tednov v velikih odmerkih (≥100 mg/kg/dan) je privedlo do statistično pomembnega povečanja pogostnosti benignih, ne pa tudi malignih tumorjev jeter.
English: Like all medicines, Zerene can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila tudi zdravilo Zerene lahko povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: 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.
Slovenian: V blagih primerih so med simptomi zaspanost, mentalna zmedenost in letargija, v resnejših primerih pa simptomi ataksija, hipotonija, hipotenzija, depresija dihanja, redko koma in zelo redko smrt.
English: Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Zerene 10 mg.
Slovenian: Spalna latenca se je v ambulantnih študijah zmanjšala za čas do 4 tednov pri nestarostnikih, ki so prejemali zdravilo Zerene 10 mg.
English: In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Slovenian: Pri zdravljenju prevelikega odmerka s katerimkoli zdravilom morate upoštevati, da je bolnik lahko zaužil več zdravil naenkrat.
English: What Zerene looks like and contents of the pack
Slovenian: Izgled zdravila Zerene in vsebina pakiranja
English: Zaleplon is lipophilic with a volume of distribution of about 1.4±0.3 l/kg following intravenous administration.
Slovenian: Zaleplon je lipofilna snov s porazdelitvenim volumnom okoli 1,4 ± 0,3 l/kg po intravenskem odmerku.
English: Co-administration of Zerene together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Slovenian: Sočasno dajanje zdravila Zerene skupaj z induktorji CYP3A4, kot so rifampicin, karbamazepin in fenobarbiton, lahko povzroči zmanjšanje učinkovitosti zaleplona.
English: Therefore, caution is advisable in co-administering cimetidine and Zerene.
Slovenian: Zato svetujemo previdnost pri sočasnem dajanju cimetidina in zdravila Zerene.
English: If you stop taking Zerene
Slovenian: Če ste prenehali jemati zdravilo Zerene
English: Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for zaleplon's metabolism.
Slovenian: Cimetidin, nespecifičen zmerni zaviralec nekaterih jetrnih encimov, vključno z aldehidno oksidazo in CYP3A4, je povzročil 85% povečanje koncentracije zaleplona v plazmi, ker je zaviral tako primarni encim (aldehidno oksidazo) in sekundarni (CYP3A4) encim, ki sta oba odgovorna za presnovo zaleplona.
English: The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and dysmenorrhea.
Slovenian: Najpogostejši neželeni učinki so amnezija, parestezija, somnolenca in dismenoreja..
English: If you forget to take Zerene
Slovenian: Če ste pozabili vzeti zdravilo Zerene
English: Take special care with Zerene
Slovenian: Bodite posebno pozorni pri jemanju zdravila Zerene
English: 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 Zerene.
Slovenian: Ker jemanje zdravila po hrani zadrži nastop maksimalne koncentracije v plazmi za približno 2 uri, ne uživajte hrane ob jemanju ali neposredno pred jemanjem zdravila Zerene.
English: • Never drink alcohol while you are being treated with Zerene.
Slovenian: • Med zdravljenjem z zdravilom Zerene nikoli ne pijte alkohola.
English: Zerene can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep.
Slovenian: Zdravilo Zerene lahko bolnik vzame tik preden gre v posteljo ali potem, ko je že v postelji in ne more zaspati.
English: Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Zerene overdose.
Slovenian: Študije na živalih kažejo, da je flumazenil antagonist zaleplona in se lahko uporablja pri zdravljenju prevelikega odmerjanja zdravila Zerene.
English: Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compoundrelated tumorigenicity.
Slovenian: Peroralno dajanje zaleplona podganam v času 104 zaporednih tednov v odmerkih do 20 mg/kg/dan ni povzročilo tumorogenih učinkov, povezanih s to spojino.
English: Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data are available on Zerene to assess its safety during pregnancy and breastfeeding.
Slovenian: Čeprav študije na živalih niso pokazale teratogenih ali embriotoksičnih učinkov, za zdravilo Zerene ni na voljo dovolj kliničnih podatkov, da bi lahko ocenili njegovo varnost v času nosečnosti in dojenja.
English: Hypersensitivity to the active substance or to any of the excipients Severe hepatic impairment
Slovenian: Preobčutljivost za zdravilno učinkovino ali katero izmed pomožnih snovi Huda jetrna okvara
English: photosensitivity reaction angioedema
Slovenian: Fotosenzitivnost Angioedem
English: Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Slovenian: Uporaba benzodiazepinov in njim sorodnih učinkovin, lahko privede do telesne in duševne odvisnosti.
English: • Do not use a second dose of Zerene within a single night.
Slovenian: • Ne vzemite drugega odmerka v isti noči.
English: Co-administration of Zerene with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's plasma concentrations.
Slovenian: Sočasna uporaba zdravila Zerene z enkratnim 800 mg odmerkom eritromicina, močnega, selektivnega zaviralca CYP3A4, je povzročila 34% povečanje koncentracije zaleplona v plazmi.
English: 7 hard capsules 10 hard capsules 14 hard capsules
Slovenian: 7 trdih kapsul 10 trdih kapsul 14 trdih kapsul
English: Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment.
Slovenian: Benzodiazepini in njim podobne snovi, lahko sprožijo anterogradno amnezijo in psihomotorične motnje.
English: Zerene has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Slovenian: Zdravilo Zerene je izdelano tako, da v primeru raztopitve vsebine kapsule v tekočini le-ta spremeni barvo in postane motna.
English: • If you are taking any medicines belonging to the sleep inducing group, including Zerene, there is a possibility that you may become dependent on them.
Slovenian: • Če jemljete katerokoli zdravilo, ki spada v skupino uspaval, vključno s Sonato, obstaja nevarnost,
English: If the medicinal product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant.
Slovenian: Če je zdravilo predpisano ženski v rodni dobi, jo morate opozoriti, naj obišče zdravnika, če namerava zanositi ali je noseča.
English: If you suffer from these symptoms, ask your doctor for advice.
Slovenian: Če imate te simptome, se posvetujte s svojim zdravnikom.
English: In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration.
Slovenian: Nasprotno pa je rifampicin, močan induktor nekaterih jetrnih encimov, vključno s CYP3A4, privedel do štirikratnega zmanjšanja koncentracije zaleplona v plazmi.
English: Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Slovenian: Respiratorna insuficienca Pri predpisovanju sedativnih zdravil bolnikom s kronično respiratorno insuficienco je potrebna previdnost.
English: No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Zerene pharmacokinetics is not altered in such patients.
Slovenian: Pri bolnikih z blago do zmerno ledvično insuficienco ni potrebna prilagoditev odmerka, ker farmakokinetika zdravila Zerene pri teh bolnikih ni spremenjena.
English: Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Slovenian: Benzodiazepini in njim sorodne učinkovine, se ne smejo uporabljati samostojno pri zdravljenju depresije ali tesnobe, povezane z depresijo (pri teh bolnikih obstaja nevarnost samomora).
English: Caution is recommended for patients performing skilled tasks.
Slovenian: Bolnikom, ki opravljajo zahtevna opravila, svetujemo previdnost.
English: Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Slovenian: Psihoza Benzodiazepini in njim sorodne učinkovine, niso priporočljive za primarno zdravljenje psihotičnih motenj.
English: Paediatric patients Zerene is contraindicated in children (see section 4.3).
Slovenian: Otroci Uporaba zdravila Zerene je kontraindicirana pri otrocih (glejte poglavje 4.3).
English: • severe breathing or chest problems
Slovenian: • če imate hude težave z dihanjem ali prsnim košem
English: INFORMATION IN BRAILLE Zerene 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zerene 5 mg
English: INFORMATION IN BRAILLE Zerene 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zerene 10 mg
English: Special attention should be paid to respiratory or cardiovascular functions in intensive care.
Slovenian: Na intenzivni negi posvetite posebno pozornost delovanju dihal in srčnožilnega sistema.
English: Zerene has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will change colour and become cloudy.
Slovenian: Zdravilo Zerene je zasnovano tako, da tekočina, v kateri se vsebina kapsule raztopi, spremeni barvo in postane motna.
English: Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.
Slovenian: Depresija Obstoječa latentna depresija lahko postane vidna med uporabo benzodiazepinov ali njim sorodnih učinkovin.
English: Common (≥1/100 to <1/10)
Slovenian: Pogosto (≥1/100 do <1/10)
English: Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism.
Slovenian: Zaleplon se presnavlja predvsem v jetrih in je podvržen pomembni predsistemski presnovi.
English: − This medicine has been prescribed for you.
Slovenian: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: What Zerene contains
Slovenian: Kaj vsebuje zdravilo Zerene
English: There is limited clinical experience with the effects of an acute overdose of Zerene, and overdose levels in humans have not been determined.
Slovenian: Klinične izkušnje z učinki akutnega prevelikega odmerka zdravila Zerene so omejene.
English: Zerene belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Slovenian: Zerene sodi v skupino zdravil, ki jih imenujemo benzodiazepinom sorodna zdravila oz. zdravila z uspavalnim delovanjem.
English: S-170 09 Solna
Slovenian: S-170 09 Solna Švedska
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Pomemben podatek o nekaterih sestavinah zdravila Zerene Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO ZA ZERENE 10 MG- VELIKOSTI PAKIRANJ 7, 10 IN 14 KAPSUL
English: • hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene
Slovenian: • če ste preobčutljivi za zaleplon ali katerokoli drugo sestavino zdravila Zerene
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Slovenian: Pogosti neželeni učinki: dremavost/zaspanost, težave s spominom, občutki kot so mravljinci, npr. v okončinah (parestezije), boleča menstruacija.
English: Zerene 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint “W”, and white body, with gold imprint “5 mg”.
Slovenian: Zerene 5 mg trde kapsule, ki vsebujejo prašek intenzivno temno modre barve, imajo svetlo rjavo kapico, na kateri je z zlato barvo natisnjena črka »W«, na belem telesu kapsule pa je natisnjeno prav tako v zlati barvi »5 mg«.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 5 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO ZA ZDRAVILO ZERENE 5 MG- VELIKOSTI PAKIRANJ 7, 10 IN 14 KAPSUL
English: Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
Slovenian: Tiskarska črnila na ovojnici kapsule vsebujejo naslednje snovi (zlato črnilo S-13050): šelak, lecitin, simetikon, rumeni železov oksid (E172).
English: Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion, abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Slovenian: Občasni neželeni učinki: omotičnost, šibkost, zmanjšana koordinacija gibov, negotovost in/ali padci (ataksija), zmanjšana koncentracija, apatija, nemir, depresija, vznemirjenos, razdražljivost, zmedenost, nenormalno mišljenje in obnašanje (ekstrovertnost, ki se zdi pretirana, popustitev zavor, agresivnost, bes, prividi, depersonalizacija, psihoza), nočne more, halucinacije, dvojni vid ali druge motnje vida, povečana občutljivost za zvok (hiperakuzija), motnje voha (parosmija), motnje govora, vključno z nerazločnim izgovarjanjem,,otopelost, npr. v okončinah (hipoestezija), slabost, zmanjšan apetit, povečana občutljivost za svetlobo (sončno svetlobo, UV svetlobo), slabo počutje (občutek bolehnosti).
English: The active substance in each Zerene hard capsule is zaleplon 5 mg.
Slovenian: Zdravilna učinkovina v vsaki trdi kapsuli Zerene je zaleplon 5 mg.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka kapsula vsebuje 5 mg zaleplona.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka kapsula vsebuje 10 mg zaleplona.
English: Capsules have an opaque white and opaque light brown hard shell with gold band, “W” and the strength “5 mg”.
Slovenian: Kapsule imajo neprozorno belo in neprozorno svetlo rjavo trdo ovojnico z zlato črto, »W« in jakostjo »5 mg«.
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Capsules have an opaque white hard shell with pink band, “W” and the strength “10 mg”.
Slovenian: Kapsule imajo neprozorno belo trdo ovojnico z rožnato črto, »W« in jakostjo »10 mg«.
English: anaphylactic/anaphylactoid reactions
Slovenian: Anafilaktične / anafilaktoidne reakcije
English: Do not use Zerene after the expiry date which is stated on the carton after EXP.
Slovenian: Zdravila Zerene ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Datum izteka roka uporabnosti zdravila se nanaša na zadnji dan navedenega meseca.
English: Chromaturia (blue-green urine discolouration) has been reported with zaleplon overdose.
Slovenian: Pri prekomernem odmerjanju zeleplona so poročali o kromaturiji (modro-zeleno obarvanje urina).
English: − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: Zerene has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Slovenian: V kontroliranih raziskavah za merjenje odstotka trajanja spanja v posameznih fazah spanja se je izkazalo, da zdravilo Zerene ohrani faze spanja.
English: Zerene 10 mg hard capsules, which contain an intensely dark blue powder, have a white cap, with pink imprint “W”, and white body, with pink imprint “10 mg”.
Slovenian: Izgled zdravila Zerene in vsebina pakiranja Zerene 10 mg trde kapsule, ki vsebujejo prašek intenzivno temno modre barve, imajo belo kapico na kateri je z rožnato barvo natisnjan črka »W«, na belem telesu kapsule pa je natisnjeno prav tako v rožnati barvi »10 mg«.
English: Skin and subcutaneous tissue disorders Uncommon:
Slovenian: Bolezni jeter, žolčnika in žolčevodov Pogostnost neznana:
English: Do not take Zerene if you have
Slovenian: Ne jemljite zdravila Zerene
English: • sleep apnoea syndrome (stopping breathing for short periods while asleep)
Slovenian: če med spanjem večkrat prenehate dihati za kratek čas)
English: Zerene should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy.
Slovenian: V tem primeru ne smete jemati zdravila Zerene, saj ni na voljo dovolj kliničnih podatkov za oceno varnosti jemanja zdravila Zerene med nosečnostjo.
English: Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.
Slovenian: Če se razvije odvisnost, se lahko pri nenadni prekinitvi zdravljenja pojavijoodtegnitveni simptomi.
English: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Slovenian: Glejte tudi spodaj pod amnezijo amnezija, parestezije, zaspanost ataksija/nekoordiniranost gibov, vrtoglavica, zmanjšana koncentracija, parosmija; motnje govora (dizartrija, nerazločno izgovarjanje); hipoestezija
English: Zerene should not be taken at this time because there are not enough clinical data available to assess its safety during breast-feeding.
Slovenian: V tem primeru ne smete jemati zdravila Zerene, saj ni na voljo dovolj kliničnih podatkov za oceno varnosti uporabe zdravila Zerene med dojenjem.
English: • severe kidney or liver problems
Slovenian: • če imate hudo ledvično ali jetrno okvaro
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Slovenian: POGOJI DOVOLJENJA ZA PROMET ZDRAVILOM
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/099/004 7 capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/099/004 7 kapsul
English: Co-administration of Zerene with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations.
Slovenian: Sočasno odmerjanje zdravila Zerene z zdravili, ki vplivajo na izoencim CYP3A4, lahko povzroči spremembe koncentracije zaleplona v plazmi (glejte poglavje 4.5).
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate and silicon dioxide.
Slovenian: Sestavine ovojnice kapsule: želatina, titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), črni železov oksid (E172), natrijev lavrilsulfat in silicijev dioksid.
English: If you have any further questions, please consult your doctor or pharmacist.
Slovenian: V primeru dodatnih vprašanj se posvetujte s svojim zdravnikom ali farmacevtom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/099/001 7 capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/99/099/001 7 kapsul