FrancophonIA/ELRC3.0 huggingface dataset:
English: Duration of immunity is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C).
Croatian: Trajanje imuniteta je približno 3 mjeseca nakon cijepljenja (dokazano u laboratorijskim uvjetima pri temperaturi vode od 12 ±2 °C).
English: No effects other than those described in section 4.6 have been observed following the administration of an overdose.
Croatian: Nisu zabilježeni drugi učinci osim onih opisanih u odjeljku 4.6 nakon predoziranja.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju da se nehotice samoinjicira, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: Personal protective equipment, for example, appropriate protective gloves, should be worn when handling the veterinary product.
Croatian: Osobna zaštita, treba nositi odgovarajuće zaštitne rukavice kod rukovanja veterinarskim proizvodom.
English: A minimum body weight of 25 g is recommended at vaccination.
Croatian: Za cijepljenje se preporuča minimalna tjelesna težina od 25 g.
English: Needle injuries at the site of injection are common following administration of the vaccine which can persist in up to 5% of fish for at least 90 days, and can be seen both macroscopically and microscopically.
Croatian: Ozljede od uboda igle na mjestu injekcije su vrlo česte nakon primjene cjepiva i mogu potrajati kod 5% riba do 90 dana te se mogu vidjeti i makroskopski i mikroskopski.
English: Atlantic salmon (Salmo salar).
Croatian: Atlantski losos (Salmo salar)
English: Position the needle at 90° in the epaxial muscle, central to the dorsal fin and above the mid-line.
Croatian: Postaviti iglu pod kutom od 90° u epaksijalni mišić, po sredini dorzalne peraje i iznad središnje crte.
English: Connect the other end of the transfer tubing set to the vaccine injection equipment (gun).
Croatian: Drugi kraj prijenosnog kompleta cjevčice spaja se za opremu za injiciranje cjepiva (pištolj).
English: WITHDRAWAL PERIOD Zero degree days.
Croatian: Nula stupnja dana.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne rabite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi.
English: CLYNAV contains a supercoiled DNA plasmid which expresses proteins of salmon alphavirus which induces a protective immune response in vaccinated Atlantic salmon.
Croatian: CLYNAV sadrži superzavijeni DNA plazmid koji izražava proteine alfavirusa lososa koji potiče zaštitni imunološki odgovor kod cijepljenog atlantskog lososa.
English: Based on a 25 g fish weight a standard 0.5 mm diameter 3mm depth needle is recommended to be used routinely.
Croatian: Temeljem standarda težine ribe od 25 g preporuča se rutinska primjena igle standardnog promjera od 0,5 mm i s dubinom uboda 3 mm.
English: Anaesthetise the fish to immobilise them, and administer 0.05 ml of the vaccine by intramuscular injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle.
Croatian: Anestezirajte ribu kako bi se umirila i dajte 0,05 ml cjepiva intramuskularnom injekcijom u predio neposredno ispred i bočno od dorzalne peraje u epaksijalni mišić.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C).
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti na hladnom (2°C-8°C).
English: Intramuscular use.
Croatian: Intramuskularna primjena
English: Do not use in clinically diseased groups of fish.
Croatian: Ne primjenjivati na skupine riba s klinički izraženom bolešću.
English: No effects other than those described in section 6 have been observed following the administration of an overdose.
Croatian: Predoziranje Nisu zabilježeni drugi učinci osim onih opisanih u odjeljku 6 nakon predoziranja.
English: TARGET SPECIES Atlantic salmon (Salmo salar).
Croatian: CILJNE VRSTE ŽIVOTINJA Atlantski losos (Salmo salar)
English: Transfer tubing kit instructions: using the spiked end, screw the transfer tubing set onto the fill port of the ethyl vinyl acetate (EVA) bag with a ¼ turn in order to secure the line in place.
Croatian: Upute za prijenosni komplet cjevčice: zašiljenim krajem zaviti prijenosni komplet cjevčice na ulazni port plastične vrećice od etil vinil acetata (EVA) okretom od ¼ kruga da cijev sjedne na mjesto.
English: Pharmacotherapeutic group: Immunologicals for Atlantic salmon.
Croatian: Farmakoterapijska grupa: imunološki proizvodi za atlantskog lososa.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA Lijekove ne treba odlagati s otpadnim vodama ni kućnim otpadom.
English: Shake product gently before use.
Croatian: Prije primjene blago protresti proizvod.
English: Do not use in broodstock.
Croatian: Ne primjenjivati kod mrijesta.
English: SPECIAL WARNING(S), IF NECESSARY
Croatian: KARENCIJA Karencija: nula stupnja dana POSEBNO(A) UPOZORENJE(A), UKOLIKO JE POTREBNO
English: A clear, colourless, particulate-free solution.
Croatian: OBLIK Otopina za injekciju Bistra, bezbojna otopina bez čestica
English: 250 ml sterile, flexible, ethyl vinyl acetate (EVA) bags with a locking snap down port. A sterile and individually packaged transfer tube set is included in the final product packaging.
Croatian: Sterilna, fleksibilna vrećica od etil vinil acetata (EVA), zapremnine 250 ml s potisnim zatvaračem snap down na ulazu.
English: Active substance: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Croatian: Djelatna tvar: pUK-SPDV-poly2#1 DNA plazmid šifre za virusni protein bolesti gušterače lososa: 5,1 - 9,4 μg.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA CLYNAV otopina za injekcije za atlantskog lososa
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Each 0.05 ml dose contains: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg.
Croatian: Jedna doza od 0,05 ml sadrži: pUK-SPDV-poly2#1 DNA plazmid šifre za virusni protein bolesti gušterače lososa: 5,1 - 9,4 μg
English: PACKAGE LEAFLET FOR: CLYNAV solution for injection for Atlantic salmon
Croatian: UPUTA O VMP ZA: CLYNAV otopina za injekcije za atlantskog lososa
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Intramuskularna injekcija Prije uporabe pročitajte Uputu o VMP.
English: Manufacturer responsible for batch release: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Lohmann Animal Health GmbH
English: Disposal: read package leaflet.
Croatian: ILI OTPADNIH MATERIJALA, AKO IH IMA Odlaganje: pročitati uputu o VMP
English: 4.11 Withdrawal period(s) Zero degree days.
Croatian: KARENCIJA Nula stupnja dana.
English: Overdose
Croatian: NUSPOJAVE
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Croatian: Izdaje se samo na veterinarski recept. 14. RIJEČI “ČUVATI IZVAN POGLEDA
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPORABLJENIH PROIZVODA
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS EVA (250 ml)
Croatian: PLASTIČNA VREĆICA (250 ml)
English: Strength Pharmaceutical Form Route of Administration
Croatian: Jačina Farmacutski oblik
English: Pack size
Croatian: Putprimjene Unutarnjepakiranje
English: One dose should be taken in the morning and one dose should be taken in the evening.
Croatian: Jedna doza se mora uzeti ujutro, a jedna navečer.
English: B-2220 Heist-op-den-Berg, Belgium
Croatian: B-2220 Heist-op-den-Berg, Belgija
English: This medicine belongs to a group of medicines called antipsychotics.
Croatian: Ovaj lijek pripada skupini lijekova koji se zovu antipsihotici.
English: Reported estimated doses were between 15 and 400 mg.
Croatian: Prijavljene procijenjene doze kretale su se između 15 i 400 mg.
English: If you are unable to take this medicine as is described below, the treatment may not be effective for you.
Croatian: Ako ne možete uzeti ovaj lijek kako je opisano, liječenje za Vas možda neće biti učinkovito.
English: Immediate medical treatment may be needed.
Croatian: Možda će biti potrebno hitno liječenje.
English: If this combination is deemed necessary, the lowest effective dose of each treatment should be prescribed.
Croatian: Ako je takva kombinacija neophodna, mora se propisati najnižu djelotvornu dozu svakog pojedinog lijeka.
English: Take the medicine pack with you.
Croatian: Ponesite sa sobom kutiju lijeka.
English: Consequently, newborn infants should be monitored carefully.
Croatian: Stoga se novorođenčad mora pomno nadzirati.
English: Paediatric population (children and adolescents)
Croatian: Pedijatrijska populacija (djeca i adolescenti)
English: What Sycrest is and what it is used for
Croatian: Što je Sycrest i za što se koristi
English: Other serious ADRs are discussed in more detail in section 4.4.
Croatian: Ostale ozbiljne nuspojave podrobnije su opisane u dijelu 4.4.
English: Other side effects reported with this medicine include:
Croatian: Druge nuspojave prijavljene tijekom primjene ovog lijeka uključuju:
English: Keep the tablet under your tongue until it dissolves.
Croatian: Držite tabletu pod jezikom dok se ne otopi.
English: If you miss one dose, take your next dose as usual.
Croatian: Ako propustite jednu dozu, uzmite sljedeću u uobičajeno vrijeme.
English: This will usually pass on its own but if it does not, tell your doctor.
Croatian: Ovi simptomi obično prolaze sami od sebe, ali ako ne prođu, obavijestite liječnika.
English: - The exact amount is shown on your Sycrest tablet pack.
Croatian: - Točna količina navedena je na Vašem pakiranju lijeka Sycrest.
English: Serious hypersensitivity reactions have been reported.
Croatian: Prijavljene su ozbiljne reakcije preosjetljivosti.
English: You should not stop taking this medicine, unless your doctor tells you as your symptoms may return.
Croatian: Ne smijete prestati uzimati ovaj lijek, osim ako Vam to nije rekao liječnik, jer se simptomi bolesti mogu vratiti.
English: You should be aware that both of these conditions may be caused by this type of medicine.
Croatian: Morate znati da ova vrsta lijekova može prouzročiti obje bolesti.
English: What Sycrest is and what it is used for What you need to know before you take Sycrest How to take Sycrest
Croatian: Što je Sycrest i za što se koristi Što morate znati prije nego počnete uzimati Sycrest Kako uzimati Sycrest
English: Exactly how this medicine works is unknown, however, it is believed to adjust the balance of these chemicals.
Croatian: Nije točno poznato na koji način djeluje ovaj lijek, ali se smatra da popravlja ravnotežu tih tvari.
English: Pharmacotherapeutic group: Psycholeptics, antipsychotics, ATC code: N05AH05
Croatian: Farmakoterapijska skupina: Psiholeptici, antipsihotici, ATK oznaka: N05AH05
English: Extrapyramidal Symptoms (EPS)
Croatian: Ekstrapiramidalni simptomi (EPS)
English: Patients should be advised to avoid alcohol while taking Sycrest.
Croatian: Bolesnicima se mora savjetovati da izbjegavaju alkohol dok uzimaju Sycrest.
English: * See subsection “Falls” below
Croatian: * vidjeti dio "Padovi" niže
English: Check with your doctor or pharmacist before taking Sycrest:
Croatian: Provjerite s liječnikom ili ljekarnikom prije nego uzmete Sycrest:
English: Do not take Sycrest while you are pregnant, unless your doctor tells you so.
Croatian: Nemojte uzimati Sycrest za vrijeme trudnoće osim ako Vam to nije rekao liječnik.
English: The tablet will dissolve in saliva within seconds.
Croatian: Tableta će se otopiti u slini za nekoliko sekundi.
English: In most cases it was not clear if asenapine had been taken sublingually.
Croatian: U većini slučajeva nije bilo jasno je li asenapin uzet sublingvalno.
English: Packs may contain 20, 60 or 100 tablets.
Croatian: Pakiranje može sadržavati 20, 60 ili 100 tableta.
English: Also contact your doctor immediately if any of these conditions develops or worsens while using Sycrest.
Croatian: Isto tako, odmah se javite liječniku ako se neko od navedenih stanja pojavi ili pogorša dok uzimate Sycrest.
English: Other medicines and Sycrest
Croatian: Drugi lijekovi i Sycrest
English: Do not take Sycrest If you are allergic to asenapine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Sycrest Ako ste alergični na asenapin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Therefore, eating and drinking should be avoided for 10 minutes after administration (see section 4.2).
Croatian: Stoga se mora izbjegavati jelo i piće 10 minuta nakon primjene lijeka (vidjeti dio 4.2).
English: In the early stages of treatment, some people may faint, especially when getting up from a lying or sitting position.
Croatian: U ranoj fazi liječenja neke osobe mogu izgubiti svijest, osobito kad ustaju iz ležećeg ili sjedećeg položaja.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije.
English: Sycrest may cause low blood pressure.
Croatian: Sycrest može uzrokovati sniženi krvni tlak.
English: Following an initial more rapid distribution phase, the terminal half-life of asenapine is approximately 24 h.
Croatian: Nakon početne brže faze raspodjele, terminalni poluvijek asenapina iznosi približno 24 h.
English: Since Sycrest can lower blood pressure, care should be taken when Sycrest is taken with other medicines that lower blood pressure.
Croatian: Budući da Sycrest može sniziti krvni tlak, potreban je oprez kad se primjenjuje zajedno s drugim lijekovima koji snižavaju krvni tlak.
English: Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters).
Croatian: Antipsihotici djeluju na spojeve koji omogućuju komunikaciju između živčanih stanica (neurotransmitere).
English: Sycrest should not be used during pregnancy unless the clinical condition of the woman requires treatment with asenapine and only if the potential benefit outweighs the potential risk to the foetus.
Croatian: Sycrest se ne smije uzimati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje asenapinom i samo ako moguća korist od liječenja nadilazi mogući rizik za plod.
English: In elderly patients (between 65 and 85 years of age), exposure to asenapine is approximately 30 % higher than in younger adults.
Croatian: U starijih je bolesnika (između 65 i 85 godina) izloženost asenapinu otprilike 30% veća nego u mlađih odraslih osoba.
English: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
Croatian: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, Nizozemska
English: What you need to know before you take Sycrest
Croatian: Što morate znati prije nego počnete uzimati Sycrest
English: - To ensure optimal absorption, place the tablet under the tongue and wait until it dissolves completely (Figure 3).
Croatian: - Kako biste osigurali optimalnu apsorpciju, stavite tabletu pod jezik i pričekajte dok se potpuno ne otopi (Slika 3).
English: The full therapeutic dose of fluvoxamine would be expected to produce a greater increase in asenapine plasma concentrations.
Croatian: Očekuje se da bi puna terapijska doza fluvoksamina izazvala veći porast koncentracije asenapina u plazmi.
English: Date of first authorisation: 01 September 2010 Date of latest renewal: 05 May 2015
Croatian: Datum posljednje obnove odobrenja: 5. svibnja 2015.
English: If you take too much Sycrest, contact a doctor straight away.
Croatian: Ako uzmete previše Sycrest tableta, odmah se javite liječniku.
English: You should tell your doctor if you are taking medicines for Parkinson's disease (such as levodopa), as this medicine may make them less effective.
Croatian: Morate obavijestiti liječnika ako uzimate lijekove za liječenje Parkinsonove bolesti (poput levodope) jer ovaj lijek može umanjiti njihovu učinkovitost.
English: Asenapine demonstrated superior efficacy to placebo in the reduction of manic symptoms over 3 weeks.
Croatian: Asenapin se pokazao djelotvornijim od placeba u smanjivanju maničnih simptoma tijekom tri tjedna.
English: There is no specific antidote to Sycrest.
Croatian: Ne postoji specifični antidot za Sycrest.
English: If you stop taking Sycrest, you will lose the effects of this medicine.
Croatian: Ako prestanete uzimati Sycrest, djelovanje ovog lijeka će se izgubiti.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako se u Vašeg djeteta pojavi neki od navedenih simptoma, možda ćete se morati javiti liječniku.
English: Very common side effects (may affect more than 1 in 10 people) - anxiety - sleepiness
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - tjeskoba - pospanost
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije padovi*
English: Cerebrovascular events have been reported in patients treated with asenapine but there is no evidence of any excess incidence over what is expected in adults between 18 and 65 years of age.
Croatian: U bolesnika liječenih asenapinom prijavljeni su cerebrovaskularni događaji, ali nema dokaza o većoj incidenciji od očekivane u odraslih osoba u dobi od 18 do 65 godina.
English: Patients from the two pivotal 3 week trials were studied for a further 9 weeks an extension trial.
Croatian: Bolesnici iz dva temeljna trotjedna ispitivanja ispitivani su u dodatnom 9-tjednom produžetku ispitivanja.
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000) and not known (cannot be estimated from the available data).
Croatian: Sve nuspojave razvrstane su prema organskim sustavima i učestalosti pojavljivanja: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you are taking this medicine and you become pregnant or you plan to get pregnant, ask your doctor as soon as possible whether you may continue taking Sycrest.
Croatian: Ako uzimate ovaj lijek i zatrudnite ili planirate trudnoću, čim prije upitajte liječnika možete li nastaviti uzimati Sycrest.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Sycrest.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Sycrest.
English: Long term efficacy could not be established in a 50-week, uncontrolled, open-label extension trial.
Croatian: Dugoročnu djelotvornost nije bilo moguće ustanoviti u 50-tjednom, nekontroliranom otvorenom nastavku ispitivanja.
English: Asenapine is rapidly distributed and has a large volume of distribution (approximately 20-25 L/kg), indicating extensive extravascular distribution.
Croatian: Asenapin se brzo raspodjeljuje i ima velik volumen distribucije (približno 20-25 l/kg), što ukazuje na opsežnu raspodjelu izvan krvnih žila.
English: - Gently remove the tablet (Figure 2).
Croatian: - Pažljivo izvadite tabletu (Slika 2).
English: Therefore, co-administration of asenapine and fluvoxamine should be approached with caution.
Croatian: Stoga se istodobnoj primjeni asenapina i fluvoksamina mora pristupiti s oprezom.
English: Sycrest sublingual tablets should not be chewed or swallowed.
Croatian: Sycrest sublingvalne tablete ne smiju se žvakati niti progutati.
English: If you miss two or more doses, contact your doctor or pharmacist.
Croatian: Ako propustite dvije ili više doza, javite se svom liječniku ili ljekarniku.
English: In a mass balance study, the majority of the radioactive dose was recovered in urine (about 50 %) and faeces (about 40 %), with only a small amount excreted in faeces (5-16 %) as unchanged compound.
Croatian: U ispitivanju masene bilance većina radioaktivno označene doze ustanovljena je u mokraći (oko 50%) i fecesu (oko 40%), dok je samo mali dio (5-16%) izlučen u fecesu u nepromijenjenom obliku.
English: Asenapine is not indicated for the treatment of children and adolescent patients below 18 years (see section 4.2).
Croatian: Asenapin nije indiciran za liječenje bolesnika dječje i adolescentske dobi mlađih od 18 godina (vidjeti dio 4.2).
English: - The other ingredients are gelatin and mannitol (E421).
Croatian: Drugi sastojci su želatina i manitol (E421).
English: Sycrest is not advised if you are unable to take the tablet as described below.
Croatian: Sycrest se ne preporučuje ako ne možete uzeti tabletu na način opisan u daljnjem tekstu.
English: The table is based on adverse reactions reported during clinical trials and/or post-marketing use.
Croatian: Tablica se temelji na nuspojavama prijavljenima u kliničkim ispitivanjima i/ili nakon stavljanja lijeka u promet.
English: Repeat-dose toxicity studies in rat and dog showed mainly dose-limiting pharmacological effects, such as sedation.
Croatian: Ispitivanja toksičnosti ponovljenih doza u štakora i pasa pokazala su uglavnom farmakološke učinke koji ograničavaju dozu, poput sedacije.
English: Potential for other medicines to affect Sycrest
Croatian: Potencijal drugih lijekova da djeluju na Sycrest
English: Be sure to tell your doctor if you meet any of these conditions as he/she may want to adjust your dose or monitor you for a while.
Croatian: Svakako obavijestite liječnika ako se nešto od navedenog odnosi na Vas jer će liječnik možda htjeti prilagoditi dozu ili Vas neko vrijeme nadzirati.
English: Asenapine is highly bound (95 %) to plasma proteins, including albumin and α1-acid glycoprotein.
Croatian: Asenapin se u velikoj mjeri (95%) veže na proteine plazme, uključujući albumin i α1-kiseli glikoprotein.
English: In case of severe extrapyramidal symptoms, anticholinergic medicines should be administered.
Croatian: U slučaju teških ekstrapiramidalnih simptoma se mora primijeniti antikolinergičke lijekove.
English: Asenapine did not impair fertility in rats and was not teratogenic in rat and rabbit.
Croatian: Asenapin nije smanjio plodnost u štakora niti je bio teratogen u štakora i kunića.
English: Do not breast-feed when taking Sycrest.
Croatian: Nemojte dojiti dok uzimate Sycrest.
English: The incidence of orthostatic hypotension in elderly subjects was 4.1 % compared to 0.3 % in the combined phase 2/3 trial population.
Croatian: Incidencija ortostatske hipotenzije u starijih je bolesnika iznosila 4,1%, u usporedbi s 0,3% u populaciji iz kombiniranog ispitivanja faze II/III.
English: Asenapine may cause somnolence and sedation.
Croatian: Asenapin može uzrokovati somnolenciju i sedaciju.
English: Limited data on efficacy in patients 65 years of age and older are available.
Croatian: Podaci o djelotvornosti u bolesnika starijih od 65 godina su ograničeni.
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
Croatian: Međutim, stariji bolesnici s demencijom koji se liječe drugim sličnim lijekovima mogu imati povećan rizik od moždanog udara ili smrti.
English: A statistically significant difference between asenapine and placebo was seen as early as day 2.
Croatian: Statistički značajna razlika između asenapina i placeba uočena je već drugog dana.
English: In subcutaneous carcinogenicity studies in rats and mice, no increases in tumour incidences were observed.
Croatian: U ispitivanjima supkutane kancerogenosti u štakora i miševa nije opažen porast incidencije tumora.