FrancophonIA/ELRC3.0 huggingface dataset:
English: Type I hydrolytic glass vials containing 10 or 50 doses of lyophilisate and 10 or 50 ml of solvent.
Slovenian: Viala iz hidrolitskega stekla tipa I, ki vsebuje 10 ali 50 odmerekov liofilizata in10 ali 50 ml vehikla.
English: 10 doses 50 doses
Slovenian: 50 odmerkov
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/.
Slovenian: Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
English: Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses against Erns-BVDV after solely herd vaccination with CP7_E2alf from responses against Erns-CSFV after natural field CSFV infection.
Slovenian: Serološke metode DIVA, ki temeljijo na odkrivanju protiteles virusa KPK, razen tistih proti E2, kot je odkrivanje protiteles proti Erns - BVDV (BVDV - virus goveje virusne driske), bi morale razlikovati med odzivom protiteles izključno pri čredah, cepjenih s CP_7E2alf, od odziva protiteles proti Erns - CSFV (CSFV - virus klasične prašičje kuge) pri živalih, ki so bile naravno okužene s terenskim virusom klasične prašičje kuge.
English: Lyophilisate: Off-white pellet Solvent: Clear colourless liquid
Slovenian: Liofilizat: pelet belkaste barve Vehikel: bistra, brezbarvna tekočina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 1 vial of 10 or 50 doses
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 1 vialo z 10 ali 50 odmerki
English: Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Slovenian: Kartonska škatla, ki vsebuje 1 vialo z 10 odmerki liofilizata in 1 vialo z 10 ml vehikla.
English: Cardboard box containing 1 vial with 50 doses of lyophilisate and 1 vial with 50 ml solvent.
Slovenian: Kartonska škatla, ki vsebuje 1 vialo z 50 odmerki liofilizata in 1 vialo z 50 ml vehikla.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila
English: EXP {month/year} Once reconstituted use immediately.
Slovenian: Rekonstituirano zdravilo uporabite takoj.
English: 10 ml 50 ml
Slovenian: 50 ml
English: RT-PCR tools could be used in outbreak situations to differentiate between the vaccine virus genome and those of fields strains based on sequences unique to the CP7_E2alf.
Slovenian: V primeru izbruha bolezni bi se na podlagi edinstvenosti sekvenc za CP7_E2alf, za razlikovanje med virusnim genomom iz cepiva in tistimi iz izoliranih sevov na terenu lahko uporabilo RT-PCR
English: Lyophilisate: bromobutyl rubber stoppers and aluminium caps Solvent: chlorobutyl rubber stoppers and aluminium caps Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Slovenian: Liofilizat: zamaški iz brombutilne gume in aluminijaste zaporke Vehikel: zamaški iz klorbutilne gume in aluminijaste zaporke
English: The recombinant vaccine virus has potential marker properties for use in DIVA (differentiation between field virus infected and solely vaccinated animals).
Slovenian: Rekombinantno cepivo ima potencialne lastnosti markerja za uporabo kot DIVA cepivo (DIVA, ang.
English: Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene (CP7_E2alf)
Slovenian: ki vsebuje gen E2 klasične prašičje kuge (CP7_E2alf)
English: TARGET SPECIES
Slovenian: CILJNE ŽIVALSKE VRSTE Prašiči
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK( DOVOLJENJA ZA PROMET
English: Marketing authorisation holder and manufacturer responsible for batch release:
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovren za sproščanje serij:
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij:
English: Suvaxyn CSF Marker lyophilisate for suspension for injection for pigs
Slovenian: Suvaxyn CSF Marker liofilizat za suspenzijo za injiciranje za prašiče
English: Vaccine virus genome is rarely detectable by RT-PCR in tonsils and lymph nodes for up to 63 days after vaccination and vaccine virus is very rarely detectable by virus isolation in tonsil for the first week after vaccination.
Slovenian: Do 63. dneva po cepljenju je virusni genom iz cepiva v tonzilah in bezgavkah redko možno dokazati z RT-PCR diagnostičnimi metodami.
English: The vaccine is a live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene.
Slovenian: Cepivo je živi rekombinatni virus goveje virusne driske z izbrisanim genom E2, ki vsebuje gen E2
English: Lyophilisate and solvent for suspension for injection for pigs
Slovenian: Liofilizat in vehikel za suspenzijo za injiciranje za prašiče
English: Pharmacotherapeutic group: live viral vaccines, live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene, ATC vet code: QI09AD04
Slovenian: IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: živa virusna cepiva, živi rekombinatni virus goveje virusne driske z izbrisanim genom E2, ki vsebuje gen E2 klasične prašičje kuge.
English: Lyophilisate: Off-white pellet
Slovenian: Liofilizat: pelet belkaste barve
English: Lyophilisate
Slovenian: INDIKACIJA
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: 16. ŠTEVILKI DOVOLJENJA ZA PROMET
English: 4.4 Special warnings for each target species
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto:
English: 6 BATCH NUMBER
Slovenian: 10 odmerkov
English: Lot {number}
Slovenian: {EXP}.
English: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Slovenian: Suvaxyn CSF Marker liofilizat in vehikel za suspenzijo za injiciranje za prašiče
English: Solvent:
Slovenian: Brejost:
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT UPORABE
English: C. STATEMENT OF THE MRLs
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
English: PACKAGE LEAFLET: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Slovenian: NAVODILO ZA UPORABO Suvaxyn CSF Marker liofilizat in vehikel za suspenzijo za injiciranje za prašiče
English: EXP {month/year} Once broached, use immediately.
Slovenian: Rekonstituirano zdravilo uporabite uporabite takoj.
English: Withdrawal period: Zero days.
Slovenian: Nastop imunosti: 14 dni po cepljenju.
English: IMMUNOLOGICAL PROPERTIES
Slovenian: KLINIČNI PODATKI
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for diacerin containing medicinal products
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 92931 Paris La Défense Cedex FRANCE
Slovenian: 92931 Paris La Défense Cedex
English: Diagonal, 67-69 08019 Barcelona Spain
Slovenian: Diagonal, 67-69 08019 Barcelona ESPAÑA
English: IZ NOE-Sued, Strasse 7, Obj.58D/1/2.OG, 2355 Wiener Neudorf, Austria
Slovenian: IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria
English: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur ISLANDE
Slovenian: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
English: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D2º
Slovenian: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D-2º 1990-090 Lisboa Portugal
English: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux FRANCE
Slovenian: 11-15 Quai de Dion Bouton 92800 Puteaux France
English: VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674, Athens
Slovenian: Gounari 150, Glyfada 16674, Athens Greece
English: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Slovenian: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes PâturesParc d'Activités des Peupliers
English: ANGELINI PHARMA HELLAS Nea Kifissia 14564, Athens Greece
Slovenian: ANGELINI PHARMA HELLAS Achaias and Troizinias, Nea Kifissia 14564, Athens Greece
English: PROTON PHARMA Anonymous Pharmaceutical Company, Achaias 4 and Trizoinias, Nea Kifissia 14564
Slovenian: PROTON PHARMA Achaias 4 and Trizoinias, Nea Kifissia 14564 Greece
English: 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Slovenian: 92300 Levallois-Perret France
English: 15, boulevard Charles de Gaulle 92700 C olombes
Slovenian: 15, boulevard Charles de Gaulle
English: MAZART 50 mg, gélule
Slovenian: MAZART 50 mg, gélule 50 mg
English: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris FRANCE
Slovenian: SUBSTIPHARM DEVELOPPEMENT 24, rue Erlanger 75016 Paris FRANCE
English: BROS EPE Avgis & Gallinis 15, n. Kifissia,
Slovenian: Avgis & Gallinis 15, n. Kifissia, 14564
English: VERBORIL 50 mg Kapseln
Slovenian: VERBORIL 50 mg Kapseln 50 mg
English: ZONDAR 50 mg, gélule
Slovenian: ZONDAR 50 mg, gélule 50 mg
English: 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
Slovenian: 92700 Colombes France
English: DIACEREIN /NORMA 50 mg capsule, hard
Slovenian: DIACEREIN/NORMA 50 mg peroralna raba
English: G. Koronis Dilou 9, Peristeri, Attikis, 12134 Greece
Slovenian: Dilou 9, Peristeri, Attikis,
English: Children (under 18 years of age)
Slovenian: Otroci (mlajši od 18 let)
English: Contact a doctor immediately and say how many capsules you have taken.
Slovenian: Nemudoma pokličite zdravnika in mu povejte, koliko kapsul ste vzeli.
English: Taking Zerene with food and drink
Slovenian: Jemanje zdravila Zerene s hrano in pijačo
English: This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication.
Slovenian: Vse to je lahko še slabše, če ste po zaužitju zdravila spali manj kot 7 do 8 ur.
English: • myasthenia gravis (very weak or tired muscles)
Slovenian: • če imate miastenijo gravis (zelo šibke ali utrujene mišice)
English: Children under 18 years of age must not take Zerene.
Slovenian: Otroci, mlajši od 18 let, ne smejo jemati zdravila Zerene.
English: Zerene will help you to sleep.
Slovenian: Zdravilo Zerene vam bo pomagalo zaspati.
English: This affects the ability to drive or use machines (see section 4.7).
Slovenian: To vpliva na sposobnost vožnje ali upravljanja s stroji (glejte poglavje 4.7).
English: 6.6 Special precautions for disposal and handling No special requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
English: Capsule core
Slovenian: Jedro kapsule:
English: hepatotoxicity (mostly described as transaminase increased)
Slovenian: Hepatotoksičnost (večinoma opisana kot povišanje transminaz)
English: To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Zerene (see section 4.7).
Slovenian: Za zmanjšanje tveganja bolniki ne bi smeli opravljati aktivnosti, ki zahtevajo psihomotorično koordinacijo do 4 ure ali več po zaužitju zdravila Zerene (glej poglavje 4.7).
English: Concomitant intake with alcohol is not recommended.
Slovenian: Sočasno zaužitje zdravila z alkoholom ni priporočljivo.
English: Results from the 2- and 4week studies showed that no pharmacological tolerance developed with any dose of Zerene.
Slovenian: Rezultati iz 2 in 4-tedenskih raziskav kažejo, da se pri nobenem odmerku zdravila Zerene ni razvila farmakološka toleranca.
English: 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)
Slovenian: Pogostnost možnih neželenih učinkov, ki so našteti spodaj, je določena z naslednjo razporeditvijo: zelo pogosti (prizadenejo več kot 1 uporabnika od 10) pogosti (prizadenejo 1 do 10 uporabnikov od 100) občasni (prizadenejo 1 do 10 uporabniokov na 1000) redki (prizadenejo 1 do 10 uporabnikov na 10.000) zelo redki (prizadenejo manj kot 1 uporabnika na 10.000) niso znani (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: • Do not use Zerene or any other sleeping medicine for longer than your doctor tells you to.
Slovenian: • Zdravila Zerene ali drugih uspaval ne jemljite dlje, kot vam je predpisal vaš zdravnik.
English: These occur most often up to several hours after ingesting the product.
Slovenian: Lete se največkrat pojavijo več ur po zaužitju zdravila.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: Zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: Tell your doctor if you are or intend to become pregnant.
Slovenian: Obvestite svojega zdravnika, če ste noseči ali nameravate zanositi.
English: When Zerene is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Slovenian: Kadar zdravilo Zerene jemljete z drugimi zdravili, ki učinkujejo na možgane, vas lahko kombinacija naredi bolj zaspane, kot bi vas smela.
English: • Use with extreme caution if you have ever been addicted to medicines or alcohol.
Slovenian: • Zdravilo Zerene uporabljajte še posebej previdno, če ste bili kdaj odvisni od zdravil ali alkohola.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION Date of first authorisation: 12 March 1999
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 12. marec 1999
English: If there is no advantage in emptying the stomach, activated charcoal should be given to reduce the absorption.
Slovenian: Če izpiranje želodca ni koristno, bolniku dajte aktivno oglje za zmanjšanje absorpcije.
English: The total daily dose of Zerene should not exceed 10 mg in any patient.
Slovenian: Celotni dnevni odmerek zdravila Zerene pri nobenem bolniku ne sme presegati 10 mg.
English: In a three month study in prepubescent dogs there was significant reduction in the weight of both prostate and testes at high multiples of the maximum therapeutic dose.
Slovenian: V trimesečni študiji s predpubertetnimi psi so opažali bistveno zmanjšanje mase prostate in testisov pri velikih mnogokratnikih največjega terapevtskega odmerka.
English: Do not take any other medicines without asking your doctor or pharmacist first.
Slovenian: Ne jemljite nobenih drugih zdravil, ne da bi se prej posvetovali s svojim zdravnikom ali farmacevtom.
English: The sedative effect may be enhanced when the product is used in combination with alcohol.
Slovenian: Pomirjevalni učinek se lahko poveča, kadar se zdravilo zaužije v kombinaciji z alkoholom.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razoporejeni po padajoči resnosti.
English: 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).
Slovenian: Uporaba zdravila (tudi pri terapevtskih odmerkih) lahko privede do nastanka telesne odvisnosti od zdravila: prekinitev terapije lahko povzroči odtegnitvene simptome ali povratni fenomen (glejte poglavje 4.4).
English: You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete cimetidin (zdravilo za želodec) ali eritromicin (antibiotik).
English: Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines.
Slovenian: Sedacija, amnezija, slabša koncentracija in slabša mišična funkcija lahko neugodno vplivajo na sposobnost vožnje in upravljanja s stroji.
English: Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Slovenian: Zaleplon se izloča v obliki neaktivnih presnovkov, predvsem s sečem (71%) in blatu (17%).
English: depersonalisation, hallucinations, depression, confusional state, apathy somnambulism
Slovenian: Depersonalizacija, halucinacije, depresija, zmedenost, apatija somnambulizem
English: Date of latest renewal: 12 March 2009
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 12. marec 2009
English: Never drink alcohol while you are being treated with Zerene (see “Take Special care with Zerene”).
Slovenian: Med zdravljenjem z zdravilom Zerene nikoli ne pijte alkohola (glejte odstavek »Bodite posebno pozorni pri jemanju zdravila Zerene«)
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Če potrebujete dodatne informacije o tem zdravilu se obrnite na lokalnega zastopnika imetnika dovoljenja za promet.
English: visual impairment, diplopia
Slovenian: Motnja vida, diplopija
English: Each pack contains 7, 10 or 14 hard capsules.
Slovenian: Vsako pakiranje vsebuje 7, 10 ali 14 trdih kapsul.
English: See also below under Depression and Psychiatric and “paradoxical” reactions
Slovenian: Glejte tudi spodaj pod Depresija in Psihiatrične in »paradoksalne« reakcije.
English: Very common (≥1/10)
Slovenian: Zelo pogosto (≥1/10)
English: Zerene did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Slovenian: Zdravilo Zerene ni vplivalo na farmakokinetični in farmakodinamični profil digoksina in varfarina, dveh učinkovin z ozkim terapevtskim indeksom.
English: • If your sleeplessness persists or worsens after a short course of Zerene treatment contact your doctor.
Slovenian: • Če nespečnost traja še naprej ali se poslabša po kratkotrajnem zdravljenju z zdravilom Zerene, se posvetujte s svojim zdravnikom.
English: Zerene may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Slovenian: Zdravilo Zerene lahko povzroči omotico, izgubo koncentracije ali spomina ali mišično šibkost.
English: Not applicable.
Slovenian: Navedba ni potrebna.
English: A routine dosage adjustment of Zerene is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Slovenian: Rutinska prilagoditev odmerka zdravila Zerene ni potrebna, vendar morate bolnike opozoriti na možnost okrepitve uspavalnih učinkov.
English: Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of Zerene at recommended doses in humans.
Slovenian: Na splošno izsledki predkliničnih študij ne kažejo nobenih bistvenih nevarnosti pri uporabi zdravila Zerene v priporočenih odmerkih za ljudi.
English: Zerene'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.
Slovenian: Učinkovitost zdravila Zerene je bila dokazana tako v študijah v spalnih laboratorijih z uporabo meritev spanja pri objektivni polisomnografiji (PSG) in v ambulantnih študijah z vprašalniki, v katerih so bolniki ocenjevali svoje spanje.
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Zerene.
Slovenian: Temu se običajno lahko izognete tako, da po zaužitju kapsule Zerene počivate vsaj 4 ure.
English: If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased (see section 4.5).
Slovenian: V primeru nezadostnega spanja se poveča možnost zmanjšane budnosti (glejte poglavje 4.5).
English: Following overdose with oral benzodiazepine or benzodiazepine-like agents, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious.
Slovenian: Po prevelikem odmerjanju peroralnih benzodiazepinov ali njim sorodnih učinkovin je treba sprožiti bruhanje (v roku ene ure), če je bolnik pri zavesti, ali opraviti izpiranje želodca z zaščito dihalnih poti, če je bolnik nezavesten.
English: In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Zerene.
Slovenian: Poleg tega ibuprofen kot primer učinkovine, ki spremenijo ledvično izločanje zdravila, ni pokazal nobenih interakcij z zdravilom Zerene.
English: Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep.
Slovenian: Zdravilo Zerene je indicirano za zdravljenje bolnikov z nespečnostjo, ki težko zaspijo.
English: Also contains: lactose monohydrate See leaflet for further information.
Slovenian: Vsebuje tudi: laktozo monohidrat Za nadaljnje informacije glejte navodilo za uporabo.
English: 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 Zerene.
Slovenian: Skupaj s selektivnostjo vezave na poseben podtip receptorjev, veliko selektivnostjo in majhno afiniteto za benzodiazepinski receptor tipa I so te lastnosti odgovorne za splošne značilnosti zdravila Zerene.
English: If you take more Zerene than you should
Slovenian: Če ste vzeli večji odmerek zdravila Zerene, kot bi smeli
English: However, there is no clinical experience with the use of flumazenil as an antidote to a Zerene overdose.
Slovenian: Vendar pa ni kliničnih izkušenj z uporabo flumazenila kot antidota pri prevelikem odmerjanju zdravila Zerene.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Slovenian: • POGOJI ALI OMEJITVEV ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Flumazenil may be useful as an antidote.
Slovenian: Flumazenil se lahko uporablja kot antidot.
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Zerene 5 mg. For severe hepatic impairment see section 4.3.
Slovenian: Ker je očistek zdravila zmanjšan, morate bolnike z blago do zmerno jetrno okvaro zdraviti z zdravilom Zerene 5 mg. Za hudo jetrno okvaro glejte poglavje 4.3.
English: Mild to moderate liver problems: Take one 5 mg capsule
Slovenian: Osebe z rahlimi do zmernimi težavami z jetri: vzemite eno 5 mg kapsulo
English: Psychiatric and “paradoxical” reactions
Slovenian: Psihiatrične in “paradoksalne” reakcije
English: Zerene is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
Slovenian: Zdravilo Zerene ni indicirano za zdravljenje bolnikov s hudo ledvično okvaro, ker pri takih bolnikih niso bile opravljene ustrezne študije.
English: Use of Zerene is not recommended during pregnancy.
Slovenian: Odsvetujemo uporabo zdravila Zerene v času nosečnosti.
English: There are different doses for people who are 65 or older, and those who have mild to moderate liver problems:
Slovenian: Za osebe, ki so stare 65 let in več in za tiste z rahlimi do zmernimi težavami z jetri so odmerki različni:
English: In Zerene studies using objective PSG measures, Zerene 10 mg was superior to placebo in decreasing sleep latency and increasing sleep duration during the first half of the night.
Slovenian: V študijah z zdravilom Zerene z uporabo objektivnih PSG meril je bilo zdravilo Zerene 10 mg boljše od placeba za zmanjšanje spalne latence in podaljšanje dolžine spanja v prvi polovici noči.
English: Zerene has major influence on the ability to drive and use machines.
Slovenian: Zdravilo Zerene ima velik vpliv na sposobnost vožnje in upravljanja s stroji.
English: Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Zerene.
Slovenian: Starejši bolniki so lahko občutljivi za učinke uspaval, zato je zanje priporočeni odmerek zdravila Zerene 5 mg.