FrancophonIA/ELRC3.0 huggingface dataset:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u odjeljku 6.1 SPC su ili odobrene tvari za koje Tablica 1 Priloga Uredbe Komisije (EU) broj 37/2010 prikazuje da MRL nije potreban ili se smatra da ne spadaju pod odredbe Uredbe ( EC) broj 470/2009 kada se upotrebljavaju u ovom veterinarsko medicinskom proizvodu.
English: The second dose of the vaccine (V2) should be administered 4 weeks later.
Croatian: Druga doza cjepiva (V2) treba se primijeniti 4 tjedna kasnije.
English: potency test
Croatian: Eur testu potencije
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 08 July 2005 / 27 July 2010
Croatian: 08 July 2005/27 July 2010
English: Package size:
Croatian: Veličine pakovanja:
English: Concurrent active and passive immunisation (emergency vaccination)
Croatian: Istovremena aktivna i pasivna imunizacija (hitno cijepljenje)
English: Cholesterol
Croatian: Kolesterol
English: A/equine-2/ South Africa/4/03
Croatian: A/equine-2/Južna Afrika/4/03
English: Merck Sharp & Dohme Animal Health, S.L.
Croatian: Merck Sharp˛Dohme Animal Health, S.L. Poligono Ind.
English: Only healthy animals should be vaccinated.
Croatian: Cijepiti samo zdrave životinje.
English: Cardboard box with 10 glass vials of 1 ml.
Croatian: Kartonska kutija s 10 staklenih bočica od 1 ml.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 2 godine
English: 1 Antigenic units
Croatian: 1Antigenska jedinica
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim gore navedenim proizvodom.
English: Tetanus toxoid
Croatian: Tetanus toksoid
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Croatian: Djelatna tvar je biološkog podrijetla namijenjena da potakne aktivni imunitet i na nju se ne primjenjuju odredbe Uredbe (EC) 470/2009.
English: This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Croatian: To dovodi do pasivne zaštite protiv tetanusa za najmanje 21 dan nakon istovremene primjene.
English: Allow the vaccine to reach room temperature before use.
Croatian: Prije primjene pustiti da cjepivo dostigne sobnu temperaturu.
English: 375 micrograms
Croatian: 375 mikrograma
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: 125 micrograms
Croatian: 125 mikrograma
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA”
English: A/equine-2/ South Africa/4/03 (50 AU), A/equine-2/Newmarket/2/93 (50 AU), Tetanus toxoid 40 Lf.
Croatian: A/equine-2/ Južna Afrika/4/03 (50 AU),A/equine-2/ Newmarket/2/93 (50 AU),Tetanus toksoid 40 Lf.
English: None
Croatian: Nema
English: 62.5 micrograms
Croatian: 62,5 mikrograma
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Čuvati izvan pogleda i dosega djece.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/05/057/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/05/057/001-004
English: Administer one dose (1 ml), by strict intramuscular injection, according to the following schedule:
Croatian: Primijeniti jednu dozu (1 ml) izričito intramuskularnom injekcijom, u skladu sa sljedećim rasporedom:
English: Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Croatian: Kartonska(e) kutija(e) s 1,5 ili 10 šprica napunjenih iglama.
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the sight and reach of children.
Croatian: I POGLEDA DJECE” Čuvati izvan pogleda i dosega djece.
English: A primary vaccination course may be considered necessary in horses that have not been suitably primed.
Croatian: Primarno cijepljenje se smatra potrebnim kod konja koji nisu redovito cijepljeni.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
English: The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE U PROMET Periodičko izvješće o neškodljivosti (PSUR) treba ponovno predavati svakih 6 mjeseci (uključujući sve veličine pakovanja proizvoda) kroz 2 godine, nakon kojih slijedi godišnji izvještaj kroz iduće 2 godine, a nakon toga za razdoblje od 3 godine.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite navedene nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
English: 4.3 Contraindications None
Croatian: 4.3 Kontraindikacije
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Stoga se odluka o primjeni ovog cjepiva prije, odnosno poslije primjene bilo kojeg drugog veterinarsko medicinskog proizvoda mora donositi od slučaja do slučaja.
English: A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
Croatian: Treće cijepljenje s Equilis Perquenza Te treba se ponoviti barem 4 tjedna kasnije.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose of vaccine, no side-effects other than those described under
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon primjene dvostruke doze cjepiva osim onih nuspojava navedenih u poglavlju 4.6, nisu primijećene nijedne druge osim depresije na dan cijepljenja.
English: Store at 2-8 °C, protected from light.
Croatian: Čuvati pri temperaturi 2 °C - 8 °C, zaštiti od svjetla.
English: Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Croatian: Tip I staklena napunjena šprica koja sadrži klip s halogenbutil završetkom zatvorena s halogenbutil čepom.
English: C/Zeppelin 6, Parcela 38 37008 Carbajosa de la Sagrada Salamanca
Croatian: 37008 Carbajosa de la Sagrada
English: Phosphate buffer, traces of thiomersal, traces of formaldehyde
Croatian: Fosfatni pufer, , tragovi formaldehida, tragovi tiomerzala 6.2 Inkompatibilnosti
English: In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Croatian: U iznimnim slučajevima lokalna reakcija može premašiti 5 cm veličine i trajati duže od 2 dana.
English: Prequenza Prequenza Te
Croatian: Equilis Prequenza Te
English: The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus.
Croatian: Cjepivo se može primjenjivati zajedno s Tetanus-Serumom od Interveta, za liječenje ozlijeđenih konja koji nisu bili cijepljeni protiv tetanusa.
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later)
Croatian: U slučaju povećanog rizika od infekcije ili nedovoljnog unosa kolostruma, dodatna početna injekcija može biti data pri starosti od 4 mjeseca kao puni program cijepljenja (primarno cijepljenje pri starosti od 6 mjeseci i 4 tjedna kasnije).
English: Equine influenza virus strains:
Croatian: Djelatne tvari: Sojevi virusa influence konja:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Doza od 1 ml sadrži:
English: In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
Croatian: U tom slučaju, prva doza (V1) cjepiva može se dati istovremeno s prikladnom profilaktičnom dozom Tetanus-Serum od Interveta na različitim mjestima uboda, koristeći zasebne šprice i igle.
English: In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Croatian: U jako rijetkim slučajevima može se pojaviti groznica popraćena letargijom i inapetencijom u iznimnim okolnostima u trajanju od 1 do 3 dana
English: • Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Croatian: • Primarno cijepljenje: prva injekcija u dobi od 6 mjeseci, druga injekcija 4 tjedna nakon prve
English: Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Croatian: Tip I staklena bočica zatvorena s halogenbutil gumenim čepom i zapečaćena aluminijskom kapicom.
English: Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Croatian: Ne cijepiti ždrebad mlađu od 6 mjeseci, posebno onu koja je oždrijebljena od kobile koja je bila revakcinirana u posljednjih dva mjeseca graviditeta, zbog moguće interferencije s maternalnim protutijelima.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: Name and address of the manufacturer of the biological active substance(s)
Croatian: Naziv i adresa proizvođača biološki djelatne(ih) tvari
English: Adjuvants: Purified Saponin
Croatian: Pročišćeni saponin
English: Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur.
Croatian: Flokulacijski ekvivalenti,odgovaraju ≥ 30 IU/ml seruma zamorca u Ph.
English: It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine.
Croatian: Preporuča se jedna booster doza samo u slučaju da je konj već primarno cijepljen sa cjepivom koje sadrži iste tipove virusa influence konja.
English: 24 months after the first revaccination
Croatian: 24 mjeseca nakon prve revakcinacije
English: TARGET SPECIES Horses
Croatian: CILJNE VRSTE ŽIVOTINJA
English: Revaccination
Croatian: Revakcinacija
English: This revaccination results in immunity to equine influenza lasting at least 12 months.
Croatian: Ova revakcinacija rezultira otpornošću na konjsku gripu najmanje 12 mjeseci.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere predostrožnosti za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 8).
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo smije biti primjenjeno istog dana, ali ne pomiješano s Tetanus serumom od Interveta (vidi odjeljak 8).
English: Zero days
Croatian: Nula dana
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 nehotičnog samo-injiciranja odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: PHARMACEUTICAL FORM Clear opalescent suspension for injection
Croatian: Bistra opalescentna suspenzija za injekciju
English: Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Croatian: U rijetkim slučajevima može se pojaviti bol na mjestu uboda, koja može rezultirati privremenom ukočenošću.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te [a clear pictogram of a horse]
Croatian: Equilis Prequenza Te [jasan piktogram konja]
English: The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course.
Croatian: Prva revakcinacija (treća doza) protiv influence konja primjenjuje se 5 mjeseci nakon primarnog cijepljenja.
English: 62.5 micrograms For a full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 4.9).
Croatian: Podaci o neškodljivosti i djelotvornosti su dostupni, što je dokaz da ovo cjepivo može biti primijenjeno istog dana, ali ne i pomiješano sa Tetanus Serum-om od Interveta.(vidjeti odjeljak 4.9)
English: 12 months after the first revaccination
Croatian: 12 mjeseci nakon prve revakcinacije
English: Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Croatian: Equilis Perquenza Te i Tetanus Serum od Interveta može smanjiti aktivnu imunizaciju protiv tetanusa u usporedbi s konjima cijepljenim s Equilis Perquenza Te u odsutnosti tetanus antitoksin seruma.
English: INDICATION(S) Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Croatian: Za aktivnu imunizaciju konja u dobi od 6 mjeseci i više protiv influence konja u svrhu smanjenja kliničkih znakova i izlučivanja virusa, te za aktivnu imunizaciju protiv tetanusa u svrhu sprečavanja smrtnost.
English: The second revaccination is given 12 months after the first revaccination.
Croatian: Druga revakcinacija se primjenjuje 12 mjeseci nakon prve revakcinacije.
English: Emil-von-Behring-Str. 76
Croatian: Emil-von-Behring-Str. 76 35 041 Marburg Njemačka
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Prequenza Te suspension for injection for horses
Croatian: Equilis Prequenza Tesuspenzija za injekciju za konje
English: Primary vaccination course
Croatian: Primarno cijepljenje
English: PACKAGE LEAFLET FOR: Equilis Prequenza Te suspension for injection for horses
Croatian: Equilis Prequenza Te, suspenzija za injekciju, za konje
English: 2 weeks after the primary vaccination course Duration of immunity: 5 months after the primary vaccination course
Croatian: Početak imuniteta: 2 tjedna nakon primarnog cijepljenja Trajanje imuniteta: 5 mjeseci nakon primarnog cijepljenja
English: INDICATION(S) Active immunisation of horses against equine influenza and tetanus
Croatian: Za aktivnu imunizaciju konja protiv influence konja i tetanusa
English: A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2 days.
Croatian: Na mjestu uboda može doći do stvaranja većih ili manjih oteklina (max. do 5 cm) u trajanju od 2 dana.
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Croatian: Za održavanje razine imunosti za komponente influence, preporučeno je prikladno cjepivo protiv konjske gripe koje sadrži sojeve A/equine 2/Južna Afrika/4/03i A/equine 2/Newmarket-2/93 u intervalu od 12 mjeseci (vidi shemu).
English: The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Croatian: Za održavanje razine imunosti za komponente influence, preporučeno je prikladno cjepivo protiv influence konja koje sadrži sojeve, A/equine 2/ Južna Afrika/4/03i A/equine-2 2/Newmarket-2/93 u intervalu od 12 mjeseci (vidi shemu).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Per dose of 1 ml:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Doza od 1 ml sadrži:
English: Prequenza
Croatian: KARENCIJA
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 1 ml:
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI Doza od 1 ml sadrži:
English: 2 weeks after the primary vaccination course Duration of immunity: 17 months after the primary vaccination course
Croatian: Trajanje imuniteta: 17 mjeseci nakon primarnog cijepljenja
English: The first revaccination is given not later than 17 months after the primary vaccination course.
Croatian: Prva revakcinacija se daje unutar 17 mjeseci koji prođu od primarnog cijepljenja.
English: To stimulate active immunity against Equine influenza and tetanus ATC-vet code: QI05AL01
Croatian: ATCvet kod: QI05AL01
English: METHOD AND ROUTE OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Read package leaflet before use.
Croatian: Prije primjene pročitati uputu o VMP
English: use
Croatian: NUSPOJAVE
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Intervet International B.V.
English: SPECIAL STORAGE CONDITIONS
Croatian: Posebne mjere predostrožnosti za čuvanje
English: Intramuscular use
Croatian: 1 ml. intramuskularnu primjenu
English: CLINICAL PARTICULARS
Croatian: FARMACEUTSKI PODACI
English: WITHDRAWAL PERIOD
Croatian: Plan cijepljenja
English: Poligono Ind. El Montalvo I
Croatian: El Montalvo I C/Zeppelin 6, Parcela 38
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Croatian: (Zaštićeno) ime Doza
English: Alcohol should be avoided.
Croatian: Alkohol treba izbjegavati.
English: It does not matter whether you take it with or without food.
Croatian: Nije važno uzimate li ih s hranom ili ne.
English: This difference was not statistically significant.
Croatian: Navedena razlika nije bila statistički značajna.
English: Always take the tablet with water and swallow it whole.
Croatian: Tabletu uvijek pijte s vodom i progutajte je cijelu.
English: It is not known if it is safe and effective in these patients.
Croatian: Nije poznato je li siguran i djelotvoran u tih bolesnika.
English: The duration of the long-term safety study was limited to 52 weeks.
Croatian: Trajanje dugoročnog ispitivanja sigurnosti bilo je ograničeno na 52 tjedna.
English: Over 75% of patients were less than 13 years of age.
Croatian: Više od 75 % bolesnika bilo je mlađe od 13 godina.
English: • This medicine has been prescribed for you only.
Croatian: Ovaj je lijek propisan samo Vama.
English: Do not use this medicine in children and adolescents under 13 years of age.
Croatian: Nemojte primjenjivati ovaj lijek u djece i adolescenata mlađih od 13 godina.
English: If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Croatian: Ako ne možete stupiti u kontakt sa svojim liječnikom, pođite u najbližu bolnicu i ponesite pakiranje sa sobom.
English: However, the clinical relevance of this finding has not been established.
Croatian: Međutim, klinička važnost ovog nalaza nije ustanovljena.
English: Recurrence prevention was not established.
Croatian: Prevencija recidiva nije utvrđena.
English: Dose adjustments due to interactions
Croatian: Prilagodbe doze zbog interakcija
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam rekli Vaš liječnik ili ljekarnik.
English: Talk to your doctor about the best way to feed your baby if you are taking this medicine.
Croatian: Razgovarajte sa svojim liječnikom o najboljem načinu na koji hraniti svoje dijete ako uzimate ovaj lijek.
English: It is especially important to mention the following to your doctor:
Croatian: Osobito je važno da kažete liječniku ako uzimate sljedeće:
English: Consequently, the frequency of these adverse events is qualified as "not known”.
Croatian: Prema tome učestalost tih nuspojava kvalificira se kao „nepoznata”.
English: This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.
Croatian: To je potrebno uzeti u obzir u slučajevima u kojima je potrebna puna pozornost, npr., prilikom upravljanja vozilom ili rukovanja strojevima.
English: The absolute oral bioavailability of the tablet formulation is 87 %.
Croatian: Apsolutna oralna bioraspoloživost formulacije tablete je 87 %.
English: Some patients may benefit from a higher dose.
Croatian: Nekim bolesnicima može koristiti viša doza.
English: Increased mortality
Croatian: Povećan mortalitet
English: If your baby develops any of these symptoms you may need to contact your doctor.
Croatian: Ako se kod Vaše bebe razvije bilo koji od ovih simptoma, možda ćete trebati obavijestiti svog liječnika.
English: There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Croatian: Ne postoje adekvatna ni dobro kontrolirana ispitivanja aripiprazola u trudnica.
English: These trials included patients with or without psychotic features and with or without a rapid-cycling course.
Croatian: Ova su ispitivanja uključila bolesnike sa ili bez psihotičnih značajki i sa ili bez brzih ciklusa.
English: People with this condition may also feel depressed, guilty, anxious or tense.
Croatian: Osobe s ovom bolešću također mogu osjećati depresiju, krivnju, tjeskobu ili napetost.
English: Therefore, cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Croatian: Stoga se odmah mora započeti s kardiovaskularnim nadzorom i uključiti kontinuirano elektrokardiografsko praćenje kako bi se otkrile moguće aritmije.
English: These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Croatian: Ti se simptomi mogu s vremenom pogoršati, ili se čak mogu razviti i nakon prekida liječenja.
English: The maximum daily dose should not exceed 30 mg.
Croatian: Maksimalna dnevna doza ne smije biti veća od 30 mg.
English: Serotonin syndrome
Croatian: Serotoninski sindrom
English: The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks.
Croatian: Liječenje treba trajati samo onoliko koliko je potrebno da se simptomi stave pod kontrolu, a ne smije biti dulje od 12 tjedana.
English: The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
Croatian: Najveća netumorogena izloženost u ženki štakora bila je 7 puta veća od izloženosti ljudi pri preporučenoj dozi.