FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take.
Croatian: Nisu provedene specifične studije koje bi dokazale izostanak utjecaja antitijela, prenesenih s majke na primjenu vakcine.
English: SP oil
Croatian: Adjuvans: SP ulje
English: Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip.
Croatian: I s pojedinačnom dozom (1 ml) zatvorena bromobutil gumenim čepom.
English: Any person intending to manufacture, import, possess, sell, supply and use Equip WNV must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati Equip WNV mora se savjetovati s nadležnim tijelom odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: In case of accidental self-injection, ingestion or spillage onto skin, seek medical advice immediately and show the package leaflet or label to the physician.
Croatian: U slučaju nehotičnog ubrizgavanja samome sebi, gutanja ili prolijevanja po koži odmah potražite liječničku pomoć i pokažite liječniku uputu o VMP ili etiketu.
English: For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Croatian: Za aktivnu imunizaciju konja starih 6 mjeseci ili starijih protiv virusa zapadnog Nila (WNV), smanjenje broja viremičnih konja nakon infekcije virusom zapadnog Nila linije sojeva 1 ili 2 i da bi se smanjilo trajanje i težina kliničkih znakova od virusa zapadnog Nila linije sojeva 2.
English: The vaccine can be used during pregnancy and lactation.
Croatian: Cjepivo se može primjenjivati tijekom graviditeta i laktacije.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: For WNV lineage 2 strains the duration of immunity has not been established.
Croatian: Za liniju sojeva 2 virusa zapadnog Nila trajanje imunosti nije utvrđeno.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses.
Croatian: Farmakoterapijska skupina: imunološki proizvodi za konje - inaktivirana virusna cjepiva -za konje
English: Duration of immunity: 12 months after primary vaccination course for WNV lineage 1 strains.
Croatian: Trajanje imuniteta: 12 mjeseci nakon primarnog ciklusa cijepljenja za virus zapadnog Nila liniju sojeva 1.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single dose syringe
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: PACKAGE SIZE 2 single-dose syringes 4 single-dose syringes 10 single-dose syringes
Croatian: VELIČINA PAKOVANJA 2 štrcaljke s pojedinačnom dozom 4 štrcaljke s pojedinačnom dozom 10 štrcaljki s pojedinačnom dozom
English: Zoetis Belgium SA Teл: +359 2 4775791
Croatian: Teл: +359 2 4775791
English: 4.2 Indications for use, specifying the target species For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.
Croatian: Za aktivnu imunizaciju konja starih 6 mjeseci ili starijih protiv virusa zapadnog Nila (WNV), smanjenje broja viremičnih konja nakon infekcije virusom bolesti zapadnog Nila linije sojeva 1 ili 2 i da bi se smanjilo trajanje i težina kliničkih znakova od virusa zapadnog Nila linije sojeva 2.
English: However, no specific efficacy studies were conducted in pregnant mares.
Croatian: Međutim, specifične studije djelotvornosti na bređim kobilama nisu provedene.
English: Packaging: box of 2, 4 or 10 single-dose syringes with needles.
Croatian: Pakovanje: kutija s 2, 4 ili 10 štrcaljki s pojedinačnim dozama i iglama.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2, 4 or 10 single-dose pre-filled syringes
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija s 2, 4, ili 10 napunjenih štrcaljki s pojedinačnom dozom.
English: The manufacture, import, possession, sale, supply and/or use of Equip WNV may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena Equip WNV može biti zabranjena u državi članici na cijelom ili na dijelu njenog teritorija sukladno nacionalnim propisima.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena ovog veterinarsko-medicinskog proizvoda može biti zabranjena u državi članici na cijelom ili na dijelu teritorija, za daljnje informacije vidi uputu o VMP.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For intramuscular use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: Inactivated West Nile virus, strain VM-2
Croatian: Inaktivirani virus zapadnog Nila, soj VM-2
English: Zoetis France Tél: +33 (0)810 734 937
Croatian: Tél: +33 (0)810 734 937
English: Inactivated West Nile virus, strain VM-2 (1.0-2.2 RP).
Croatian: Djelatna tvar: Inaktivirani virus zapadnog Nila, soj VM-2 RP* 1,0 - 2,2
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: 11. POSEBNE MJERE OPREZA PRI ČUVANJU Držati izvan pogleda i dosega djece.
English: Shelf life of the veterinary product as packaged for sale: pre-filled glass syringe: 2 years.
Croatian: napunjena staklena štrcaljka: 2 godine.
English: No specific efficacy studies were conducted in pregnant mares.
Croatian: Nisu provedena specifična istraživanja djelotvornosti na bređim kobilama.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 1 ml contains:
Croatian: I DRUGIH TVARI 1 ml sadrži:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equip WNV emulsion for injection for horses
Croatian: UPUTA O VMP Equip WNV emulzija za injekciju za konje
English: Agrimed Limited Tel: +356 21 465 797
Croatian: Tel: +356 21 465 797
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja).
English: PACKAGE LEAFLET FOR: Equip WNV emulsion for injection for horses
Croatian: Equip WNV emulzija za injekciju za konje
English: Zoetis Belgium SA Tel: +353 (0) 1 256 9800
Croatian: Tel: +353 (0) 1 256 9800
English: ADVICE ON CORRECT ADMINISTRATION Not applicable.
Croatian: SAVIJETI ZA ISPRAVNU PRIMJENU
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated West Nile virus, strain VM-2.
Croatian: Djelatna tvar: Inaktivirani virus zapadnog Nila, soj VM-2
English: Oriola Vilnius UAB Tel: +370 610 05088
Croatian: Tel: +370 610 05088
English: Luxembourg/ Luxemburg Zoetis Belgium SA Tél/Tel.
Croatian: Luxembourg / Luxemburg
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: država članica može zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da:
English: Active substance:
Croatian: KOLIČINA DJELATNE(IH) TVARI
English: SPECIAL WARNING(S) Special precautions for use in animals: Vaccinate healthy animals only.
Croatian: Posebne mjere opreza prilikom primijene na životinjama:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana).
English: United Kingdom Zoetis UK Limited Tel: +44 (0) 845 300 8034
Croatian: Tel: +44 (0) 845 300 8034
English: Magyarország Zoetis Hungary Kft. Tel: +361 224 5222
Croatian: Slovenská republika Zoetis Česká republika, s.r.o. Tel: +420 257 101 111
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom day.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Pregabalin Zentiva is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Croatian: Lijek Pregabalin Zentiva dostupan je u tabletama (25, 50, 75, 100, 150, 200, 225 i 300 mg), a izdaje se samo na recept.
English: Stopping treatment with Pregabalin Zentiva should also be done gradually, over at least a week.
Croatian: Prekid terapije lijekom Pregabalin Zentiva treba također provoditi postepeno, tijekom najmanje jednog tjedna.
English: This summary was last updated in July-2015.
Croatian: Sažetak je posljednji put ažuriran u srpnju 2015.
English: The recommended starting dose is 150 mg per day, divided into two or three doses.
Croatian: Preporučena početna doza iznosi 150 mg na dan, podijeljeno u dvije ili tri doze.
English: Doses can be increased up to twice more until the most effective dose is reached.
Croatian: dvostruko veće doze sve dok se ne dosegne djelotvorna doza.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Croatian: Ovo smanjuje djelovanje pojedinih živčanih stanica u mozgu i kralježničnoj moždini, smanjujući otpuštanje drugih neurotransmitera koji su uključeni u epilepsiju i anksioznost.
English: Pregabalin Zentiva is a medicine used to treat adults with the following conditions:
Croatian: Pregabalin Zentiva je lijek koji se koristi za liječenje odraslih osoba sa sljedećim stanjima:
English: This means that Pregabalin Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Croatian: To znači da je Pregabalin Zentiva sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Lyrica.
English: The maximum dose is 600 mg per
Croatian: Maksimalna doza je 600 mg na dan.
English: Pregabalin Zentiva is a ‘generic medicine'.
Croatian: Pregabalin Zentiva je „generički lijek”.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Zentiva on 17 July 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Pregabalin Zentiva na snazi u Europskoj uniji od 17. srpnja 2015.
English: The active substance in Pregabalin Zentiva, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Croatian: Djelatna tvar lijeka Pregabalin Zentiva, pregabalin, slična je po strukturi neurotransmiteru tijela gamaaminobutiričnoj kiselini (GABA), no ima vrlo drugačije biološko djelovanje.
English: The Committee recommended that Pregabalin Zentiva be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Pregabalin Zentiva za korištenje u EU-u.
English: What is Pregabalin Zentiva and what is it used for?
Croatian: Što je Pregabalin Zentiva i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Zentiva.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Pregabalin Zentiva.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Zentiva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pregabalin Zentiva?
English: A risk management plan has been developed to ensure that Pregabalin Zentiva is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pregabalin Zentiva.
English: What are the benefits and risks of Pregabalin Zentiva?
Croatian: Koje su koristi i rizici od lijeka Pregabalin Zentiva?
English: It is not intended to provide practical advice on how to use Pregabalin Zentiva.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pregabalin Zentiva.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Pregabalin Zentiva nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva has been shown to have comparable quality and to be bioequivalent to Lyrica.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno kako Pregabalin Zentiva posjeduje usporedivu kakvoću te je bioekvivalentan s lijekom Lyrica.
English: Because Pregabalin Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Pregabalin Zentiva generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: Other information about Pregabalin Zentiva
Croatian: Ostale informacije o lijeku Pregabalin Zentiva
English: For practical information about using Pregabalin Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Pregabalin Zentiva bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Croatian: • epilepsijom, kada se koristi kao dodatna terapija postojećoj terapiji u bolesnika koji imaju djelomične napadaje (epileptične napadaje u jednom specifičnom djelu mozga) koji se ne može kontrolirati s njihovim aktualnim liječenjem;
English: Why is Pregabalin Zentiva approved?
Croatian: Zašto je Pregabalin Zentiva odobren?
English: The full EPAR and risk management plan summary for Pregabalin Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Pregabalin Zentiva nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o liječenju lijekom Pregabalin Zentiva pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da kao i u slučaju lijeka Pregabalin Zentiva koristi nadmašuju utvrđene rizike.
English: Because Pregabalin Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Croatian: Budući da je Pregabalin Zentiva generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Lyrica.
English: Pregabalin Zentiva contains the active substance pregabalin.
Croatian: Pregabalin Zentiva sadrži djelatnu tvar pregabalin.
English: How is Pregabalin Zentiva used?
Croatian: Kako se koristi Pregabalin Zentiva?
English: How has Pregabalin Zentiva been studied?
Croatian: Kako je Pregabalin Zentiva ispitivan?
English: How does Pregabalin Zentiva work?
Croatian: Kako djeluje Pregabalin Zentiva?
English: <and>
Croatian: <i>
English: CONCLUSIONS ON <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Croatian: ZAKLJUČCI EUROPSKE AGENCIJE ZA LIJEKOVE O <SLIČNOSTI I ODSTUPANJU> <I> < ZAHTJEVU ZA JEDNOGODIŠNJU <ZAŠTITU STAVLJANJA LIJEKA U PROMET> <ZAŠTITU PODATAKA O LIJEKU>>
English: [Art 74(a)- legal status switch]<Furthermore, the CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 74(a) of Directive 2001/83/EC, and considers that the data submitted in support of the classification of {specify medicinal product name} as ‘medicinal product not subject to medical prescription' were significant as further explained in the European Public Assessment Report.>
Croatian: [Art 74(a)- legal status switch]<Osim toga, CHMP je pregledao podatke koje je dostavio nositelj odobrenja, sukladno čl. 74(a) Direktive 2001/83/EZ, te smatra da su podaci koji podupiru klasifikaciju {navesti ime lijeka} kao „lijeka koji se izdaje bez recepta”, bili značajni, što je dodatno pojašnjeno u Europskom javnom izvješću o ocjeni lijeka.>
English: <The CHMP is of the opinion that <name of product> is similar to authorised orphan medicinal product(s) within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report.
Croatian: <Mišljenje je CHMP-a da je <naziv lijeka> sličan odobrenom (im) lijeku (ovima) za rijetke i teške bolesti („orphan“ lijek) sukladno čl. 3 Uredbe Komisije (EZ) br. 847/2000, što je dodatno pojašnjeno u Europskom javnom izvješću o ocjeni lijeka.
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>.
Croatian: <podnositelj zahtjeva može utvrditi u zahtjevu da je lijek, iako sličan <odobrenom lijeku za rijetke i teške bolesti>, sigurniji, učinkovitiji ili na neki drugi način klinički superiorniji (prema definicijama u čl.
English: (20.3, NE)
Croatian: (20,3; NO)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20 November 2015
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA 20. studenoga 2015.
English: · This medicine has been prescribed for you only.
Croatian: · Ovaj je lijek propisan samo Vama.
English: Ask your doctor about the best contraception for you.
Croatian: Razgovarajte sa svojim liječnikom o najboljoj kontracepciji za Vas.
English: Cotellic is taken on a 28 day cycle.
Croatian: Cotellic se uzima u 28-dnevnim ciklusima.
English: · Do not throw away any medicines via wastewater or household waste.
Croatian: · Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: On average, 94% of the dose was recovered within 17 days.
Croatian: U prosjeku se 94% doze izlučilo iz tijela unutar 17 dana.
English: N/A = Not Applicable
Croatian: N/P = nije primjenjivo
English: Study NO25395 (BRIM7)
Croatian: Ispitivanje NO25395 (BRIM7)
English: · Do not take a double dose to make up for a missed dose.
Croatian: · Nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: · Take the tablets every day for 21 days (called a “treatment period”).
Croatian: · Uzimajte tablete svaki dan tijekom razdoblja od 21 dana (to se naziva "razdobljem liječenja").
English: These data show that the efficacy of the combination will be lower in these patients (see section 5.1).
Croatian: Ti podaci pokazuju da će djelotvornost ove kombinacije u tih bolesnika biti manja (vidjeti dio 5.1).
English: · After the 21 days, do not take any Cotellic tablets for 7 days.
Croatian: · Nakon 21 dana, nemojte uzimati Cotellic tablete 7 dana.
English: Changes in reported laboratory data
Croatian: Promjene u prijavljenim laboratorijskim vrijednostima
English: Patients should be closely monitored.
Croatian: Potrebno je pomno nadzirati bolesnike.
English: They can be taken with or without food.
Croatian: Mogu se uzimati s hranom ili bez nje.
English: Transparent PVC/PVDC blisters containing 21 tablets.
Croatian: Prozirni PVC/PVDC blisteri koji sadrže 21 tabletu.
English: Cotellic is not recommended for children and adolescents.
Croatian: Cotellic se ne preporučuje za primjenu u djece i adolescenata.
English: The magnitude of interaction could potentially be lower in patients.
Croatian: Opseg te interakcije mogao bi biti manji u bolesnika.
English: The majority of events were Grade 1 or 2 and non-serious.
Croatian: Većina događaja bila je 1. ili 2. stupnja težine te nije bila ozbiljna.
English: Mortality occurred in juvenile animals at a dose (3 mg/kg) which did not lead to mortalities in adult animals.
Croatian: Smrt je u juvenilnih štakora nastupila pri dozi (3 mg/kg) koja nije uzrokovala smrt u odraslih životinja.
English: The difference in ORR was 22.9 % (p-value<0.0001).
Croatian: Razlika u ORR-u bila je 22,9% (p-vrijednost < 0,0001).
English: · This medicine does not require any special storage conditions.
Croatian: · Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Before starting treatment, your doctor will test for this mutation.
Croatian: Prije početka liječenja liječnik će napraviti test na tu mutaciju.
English: If doses are omitted for toxicity, these doses should not be replaced.
Croatian: Ako se doze propuste zbog toksičnosti, te se doze ne smiju nadomjestiti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1048/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1048/001
English: The transport across the blood brain barrier is unknown.
Croatian: Prijenos kroz krvno-moždanu barijeru nije poznat.
English: What you need to know before you take Cotellic 3.
Croatian: Što morate znati prije nego počnete uzimati Cotellic
English: Study GO28141 (coBRIM)
Croatian: Ispitivanje GO28141 (coBRIM)
English: · Cotellic can be taken with or without food.
Croatian: · Cotellic se može uzimati s hranom ili bez nje.
English: 0.70 (95% CI: 0.55, 0.90) (p-value = 0.0050
Croatian: 0,70 (95% CI: 0,55, 0,90) e) (p-vrijednost = 0,0050
English: If you stop taking Cotellic
Croatian: Ako prestanete uzimati Cotellic
English: · If you become pregnant during treatment with Cotellic or in the 3 months after your last dose, tell your doctor straight away.
Croatian: · Ako zatrudnite tijekom liječenja lijekom Cotellic ili unutar 3 mjeseca nakon uzimanja posljednje doze, odmah o tome obavijestite svog liječnika.
English: The safety and efficacy of Cotellic in children and adolescents below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Cotellic u djece i adolescenata mlađih od 18 godina nisu ustanovljene.