FrancophonIA/ELRC3.0 huggingface dataset:
English: No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Croatian: Nisu dostupni podaci o primjeni cjepiva kod seropozitivnih goveda, uključujući one s materinjim antitijelima.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjenih za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Croatian: Povremeno, prisustvo materinjih antitijela kod ovaca minimalne preporučene starosti povremeno može interferirati sa zaštitom koju inducira cjepivo.
English: An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Croatian: Prosječno povećanje temperature tijela varira između 0,5 i 1,0 ºC i česta je reakcija uočena u ovaca i goveda.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, 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) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
English: EXP {month/year} Once broached, use within 10 hours.
Croatian: EXP {mjesec/godina} Jednom otvoren, upotrijebiti unutar 10 sati.
English: Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine.
Croatian: Povremeno se opaža blagi porast temperature (0,5 ºC - 1,0 ºC) tijekom 24-48 sati nakon primjene dvostruke doze cjepiva.
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: Odluku o primjeni ovog cjepiva prije odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda treba donositi od slučaja do slučaja.
English: Hypersensitivity reactions are very rarely observed.
Croatian: U vrlo rijetkim slučajevima, opažaju se reakcije preosjetljivosti.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: {DD/MM/GGGG} Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: SC
Croatian: s.c
English: Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful.
Croatian: U vrlo rijetkim slučajevima na mjestu injiciranja javljaju se privremene lokalne reakcije, u obliku čvorića promjera od 0,5 do 1 cm u ovaca, odnosno od 0,5 do 3 cm u goveda, koji nestaje najkasnije u roku od 14 dana i koja može biti bolna.
English: The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle).
Croatian: Nisu utvrđene sigurnost i djelotvornost ovog cjepiva kod rasplodnih mužjaka (ovnova i bikova).
English: Store and transport refrigerated (2 ºC - 8 ºC).
Croatian: Čuvati i prevoziti na hladnom (2 ºC - 8 ºC).
English: Aluminium hydroxide Purified saponin (Quil A) Thiomersal
Croatian: Aluminijev hidroksid Pročišćeni saponin (Quil A) Tiomersal
English: Marketing authorisation holder: Intervet International BV
Croatian: Nositelj odobrenja za stavljanje u promet: Intervet International BV
English: {MM/YYYY}
Croatian: {MM/ GGGG}
English: Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
Croatian: Fiziološka otopina puferirana fosfatom (natrijev klorid, dinatrijev fosfat i kalijev fosfat, voda za injekcije)
English: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Croatian: Primijeniti dvije doze od 4 ml potkožno s intervalom od 3 tjedna.
English: Administer two doses of 2 ml subcutaneously with a 3 week interval.
Croatian: Primijeniti dvije doze od 2 ml potkožno s intervalom od 3 tjedna.
English: Inactivated BTV8: 106.5 CCID50/ml
Croatian: Inaktivirani BTV8: 106,5 CCID50/ml
English: Bovilis Blue-8 suspension for injection for cattle and sheep
Croatian: Bovilis Blue-8 suspenzija za injekciju za goveda i ovce
English: Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Croatian: Bovilis Blue-8 stimulira aktivni imunitet na virus plavog virusa, serotip 8.
English: Manufacturer responsible for batch release: Intervet UK Ltd
Croatian: Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet: Intervet UK Ltd
English: Each ml contains: Inactivated BTV8: 106.5 CCID50
Croatian: Svaki ml sadrži: Inaktivirani BTV8: 106,5 CCID50
English: Package sizes:
Croatian: Veličina pakiranja:
English: High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and aluminium seals.
Croatian: Bočice od polietilena visoke gustoće (HDPE) od 52 ml, 100 ml ili 252 ml s bromobutilnim čepovima i aluminijskim brtvama.
English: For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.
Croatian: Za aktivnu imunizaciju goveda počevši od 2,5 mjeseci života za prevenciju viremije* uzrokovane serotipom 8 virusa bolesti plavog jezika.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Croatian: Nema negativnog utjecaja na prinos mlijeka kad se cjepivo primjenjuje ovcama i kravama u fazi laktacije.
English: Cattle and sheep
Croatian: Goveda i ovce
English: Shelf life after first opening the immediate packaging: 10 hours.
Croatian: Rok valjanosti nakon prvog otvaranja unutarnjeg pakovanja: 10 sati.
English: Box with 1 bottle of 52 ml, 100 ml or 252 ml.
Croatian: Kutija s 1 bočicom od 52 ml, 100 ml ili 252 ml.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Uputa o veterinarsko-medicinskom proizvodu treba imati naziv i adresu proizvođača odgovornog za puštanje serije u promet za važeću seriju.
English: PSUR submissions for Bovilis Blue-8 shall be synchronised and submitted at the same frequency as for Bluevac BTV8.
Croatian: PSUR za Bovilis Blue -8 će biti predavan usklađeno sa Bluevac BTV 8.
English: Bluetongue virus inactivated, serotype 8: 106.5 CCID50* (* equivalent to titre prior to inactivation)
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 8: 106,5 CCID50* (*jednako titru prije inaktivacije)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija (52 ml, 100 ml i 252 ml)
English: Pharmacotherapeutic group: Immunologicals for Bovidae/Ovidae, inactivated bluetongue virus vaccines.
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska skupina: imunološki pripravci za goveda/ovce, cjepiva s inaktiviranim virusom plavog jezika.
English: Store and transport refrigerated (2 °C - 8 °C).
Croatian: 6.4 Posebne mjere pri čuvanju Čuvati i prevoziti u hladnjaku (2 °C - 8 °C).
English: Bluetongue virus inactivated, serotype 8 106.5 CCID50* Aluminium hydroxide
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 8 106,5 CCID50* Aluminijev hidroksid
English: Revaccination:
Croatian: Ponovno cijepljenje:
English: PACKAGE LEAFLET: Bovilis Blue-8 suspension for injection for cattle and sheep
Croatian: UPUTA O VMP ZA: Bovilis Blue-8 suspenzija za injekciju za goveda i ovce
English: 31 days after the second dose.
Croatian: Početak imunosti: 31 dan nakon druge doze.
English: Cardboard box with 1 bottle containing either 126 sheep doses or 63 cattle doses (252 ml).
Croatian: Kartonska kutija s 1 bočicom koja sadrži 126 doza za ovce ili 63 doze za goveda (252 ml).
English: 20 days after the second dose.
Croatian: Početak imunosti: 20 dana nakon druge doze.
English: Cardboard box with 1 bottle containing either 50 sheep doses or 25 cattle doses (100 ml).
Croatian: Kartonska kutija s 1 bočicom koja sadrži 50 doza za ovce ili 25 doza za goveda (100 ml).
English: Cardboard box with 1 bottle containing either 26 sheep doses or 13 cattle doses (52 ml).
Croatian: Veličine pakiranja: Kartonska kutija s 1 bočicom koja sadrži 26 doza za ovce ili 13 doza za goveda (52 ml).
English: EU/2/17/218/001 EU/2/17/218/002
Croatian: EU/2/17/218/002
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
Croatian: Povremeno se nakon primjene dvostruke doze javljaju bezbolne otekline veličine do 2 cm kod ovaca i 4,5 cm kod goveda.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 252 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica od 100 ml i 252 ml
English: Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Croatian: Wim de Körverstraat 35, 5831 AN Boxmeer
English: Name and address of the manufacturer of the biological active substance CZ Veterinaria, S.A.
Croatian: Naziv i adresa proizvođača biološki djelatne tvari
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: 11. POSEBNE MJERE PRI ČUVANJU Držati izvan pogleda i dosega djece.
English: For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Croatian: Za aktivnu imunizaciju ovaca počevši od 2,5 mjeseca života za prevenciju viremije* i za smanjenje kliničkih znakova uzrokovanih serotipom 8 virusa bolesti plavog jezika. *(Ciklička vrijednost (Ct) ≥ 36 prema validiranoj metodi RT-PCR, što ukazuje na odsutnost virusnog genoma).
English: Cattle: QI02AA08 / Sheep: QI04AA02 Bovilis Blue-8 stimulates active immunity against bluetongue virus, serotype 8.
Croatian: ATKvet kodovi: goveda: QI02AA08 / ovce: QI04AA02
English: Transient fever was observed in rare cases.
Croatian: U rijetkim slučajevima bilo je zabilježeno kratkotrajno povećanje tjelesne temperature.
English: Excipient:
Croatian: Laktacija:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 52 ml
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: Withdrawal period: Zero days
Croatian: KARENCIJA Karencija: nula dana
English: Onset of immunity:
Croatian: Inkompatibilnosti:
English: {DD/MM/YYYY}
Croatian: EXP {mjesec/godina}
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Intervet UK Ltd
English: Pregnancy and lactation:
Croatian: Graviditet:
English: Eating less than usual.
Croatian: • jedu manje nego obično.
English: Then drink some water.
Croatian: Zatim popijte malo vode.
English: Do not try to drive.
Croatian: Nemojte pokušavati voziti.
English: Your doctor will tell you whether you need all 4 packages.
Croatian: Liječnik će Vam reći trebate li sva 4 pakiranja.
English: Make sure it is fixed well in place.
Croatian: Pobrinite se da je dobro pričvršćen.
English: A worsening of your disease can also harm your baby.
Croatian: Pogoršanje Vaše bolesti može biti štetno i za dijete.
English: The duration of the treatment was up to 121 weeks depending on the response.
Croatian: Liječenje je trajalo do 121 tjedana, ovisno o odgovoru.
English: Elderly (over 65 years of age)
Croatian: Starije osobe (iznad 65 godina života)
English: 3 years After first opening: 2 months.
Croatian: Nakon prvog otvaranja: 2 mjeseca.
English: An increased variability in exposure was also observed.
Croatian: Povećanje varijabilnosti u izloženosti također je uočeno.
English: This is partly related to lower body weight.
Croatian: To je dijelom povezano s manjom tjelesnom težinom.
English: Clinical efficacy and safety Adult population
Croatian: Klinička djelotvornost i sigurnost Odrasla populacija
English: - Maintenance treatment (after the first 4 weeks)
Croatian: Održavanje liječenja (nakon prva 4 tjedna)
English: This leaflet was last revised in {month/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {mjesec/GGGG}.
English: Suicidal ideation and behaviour
Croatian: Suicidalne ideacije i ponašanje
English: You do not need to remove the adaptor after use.
Croatian: Ne trebate ukloniti nastavak nakon uporabe.
English: If you are not sure whether you are allergic, please discuss with your doctor.
Croatian: Ako niste sigurni jeste li alergični, molimo razgovarajte sa svojim liječnikom
English: After the first 4 weeks of treatment, your doctor may adjust the dose with which you will continue your long term treatment.
Croatian: Nakon prva 4 tjedna liječenja liječnik će Vam možda prilagoditi dozu s kojom ćete nastaviti Vaše dugotrajno liječenje.
English: Opening date (only for the outer carton)
Croatian: Datum otvaranja (samo za vanjsku kutiju)
English: Children less than 4 years
Croatian: Djeca mlađa od 4 godine
English: Your doctor will show you how to use the oral syringe, before you use it for the first time.
Croatian: Vaš će Vam liječnik pokazati kako upotrebljavati štrcaljku za usta prije nego što je prvi put upotrijebite.
English: The doctor will prescribe the formulation that is best suited to them.
Croatian: Liječnik će propisati formulaciju koja im najbolje odgovara.
English: Your doctor will decide for how many days you will have infusions.
Croatian: • Vaš će liječnik odlučiti koliko ćete dana primati infuziju.
English: TOTAL daily dose
Croatian: UKUPNA dnevna doza
English: Moreover, effective antiepileptic therapy must not be interrupted, since the aggravation of the illness is detrimental to both the mother and the foetus.
Croatian: Štoviše, učinkovitu antiepileptičku terapiju ne smije se prekidati jer pogoršanje bolesti šteti i majci i fetusu.
English: The rates were also similar to those observed in the overall population.
Croatian: Stope su također bile slične onima utvrđenim u cjelokupnoj populaciji.
English: you are often dizzy or fall over.
Croatian: • ako često imate omaglicu ili padate.
English: First dose (in the morning)
Croatian: Prva doza (ujutro)
English: Irritability, trouble sleeping, depression;
Croatian: • razdražljivost, poteškoće sa spavanjem, depresija;
English: Titration (incremental steps)
Croatian: Titracija (koraci povećanja)
English: Some were dose-related and could be alleviated by reducing the dose.
Croatian: Neke su ovisile o dozi i mogle su biti ublažene smanjenjem doze.
English: If women decide to become pregnant, the use of this product should be carefully re-evaluated.
Croatian: Ako žena odluči zatrudnjeti, primjenu tog lijeka treba pažljivo procijeniti.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: This belongs to a group of medicines called “antiepileptic medicines”.
Croatian: On pripada skupini lijekova koji se nazivaju „antiepileptički lijekovi“.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for lacosamide.
Croatian: Mehanizam tog rizika nije poznat, a dostupni podaci ne isključuju mogućnost postojanja povećanog rizika za lakozamid.
English: Lacosamide should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Croatian: Lakozamid ne bi trebalo koristiti u trudnoći osim ako nije nužno potreban (ako korist za majku značajno nadilazi potencijalni rizik za fetus).
English: These medicines are used to treat epilepsy.
Croatian: Ti se lijekovi upotrebljavaju u liječenju epilepsije.
English: Try to take it at about the same time each day.
Croatian: • Nastojte ga uzimati u otprilike isto vrijeme svakog dana.
English: Instead take Lacosamide UCB at the next time that you would normally take it.
Croatian: Umjesto toga, uzmite Lakozamid UCB u sljedeće vrijeme kada ga uobičajeno uzimate.
English: Difficulties in coordinating your movements or walking.
Croatian: • poteškoće u koordinaciji pokreta ili hodanju.
English: The body weight normalized difference is 26 and 23 %, respectively.
Croatian: Normalizirana razlika prema tjelesnoj težini bila je 26 odnosno 23 %.
English: Patients should not take a double dose.
Croatian: Bolesnici ne smiju uzeti dvostruku dozu.
English: Apart from the hypertrophy of hepatocytes, no other histopathologic changes were observed.
Croatian: Osim hipertrofije hepatocita nisu nađene druge histopatološke promjene.
English: You will usually start by taking a low dose each day and your doctor will slowly increase this over a number of weeks.
Croatian: Obično se počinje uzimati niska doza svakog dana, koju će Vaš liječnik polako povećavati tijekom nekoliko tjedana.
English: Multiorgan hypersensitivity reactions
Croatian: Multiorganske reakcije preosjetljivosti
English: When prescribing the syrup the dose should be expressed in volume (ml) rather than weight (mg).
Croatian: Pri propisivanju sirupa doza se treba izraziti u volumenu (ml) umjesto u težini (mg).
English: Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Croatian: Stoga treba nadzirati bolesnike kako bi se uočili znakovi suicidalnih ideacija i ponašanja i treba razmotriti odgovarajuće liječenje.
English: For single use only
Croatian: Za jednokratnu uporabu.
English: More details are provided in the table below.
Croatian: Više detalja navedeno je u donjoj tablici.
English: The IV infusion is usually used for a short time when you cannot take the medicine by mouth.
Croatian: • i.v. infuzija obično se primjenjuje kratkotrajno kada ne možete uzimati lijek kroz usta.
English: After first opening, bottle may be used for up to 2 months.
Croatian: Nakon prvog otvaranja boca se smije upotrebljavati do 2 mjeseca.
English: Single loading dose (if applicable)
Croatian: Jednokratna udarna doza (ako je primjenjivo)
English: The plasma concentration increases with an accumulation factor of approximately 2.
Croatian: Koncentracija u plazmi raste s faktorom akumulacije od oko 2.
English: When you reach the dose that works for you, this is called the “maintenance dose”, you then take the same amount each day.
Croatian: Kada dosegnete dozu koja Vam odgovara, koja se naziva „doza održavanja“, uzimat ćete istu količinu svakog dana.
English: The volume of distribution is approximately 0.6 L/kg.
Croatian: Volumen distribucije otprilike je 0,6 l/kg.
English: Once you have opened the syrup bottle, do not use beyond 2 months.
Croatian: Jednom kada ste otvorili bocu sirupa, ne smijete je upotrebljavati dulje od 2 mjeseca.
English: 40789 Monheim am Rhein GERMANY
Croatian: 40789 Monheim am Rhein NJEMAČKA
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne smiju uzimati ovaj lijek.
English: Potential for electro-clinical worsening in specific paediatric epilepsy syndromes
Croatian: Mogućnost elektrokliničkog pogoršanja u pojedinim pedijatrijskim epileptičkim sindromima
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be estimated from available data).
Croatian: Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: This major metabolite has no known pharmacological activity.
Croatian: Taj glavni metabolit nema poznatu farmakološku aktivnost.
English: These differences between elderly and younger adult patients were similar to those observed in the active comparator group.
Croatian: Te razlike između starijih i mlađih odraslih bolesnika bile su slične onima u skupini s aktivnim usporednim lijekom.
English: They usually start treatment with the syrup and only change to tablets if they are able to take tablets and get the correct dose with the different tablet strengths.
Croatian: Obično započinju liječenje sirupom i prelaze na tablete samo ako mogu uzimati tablete i dobiti točnu dozu s različitim jačinama tableta.
English: Data generally suggest that lacosamide has a low interaction potential.
Croatian: Podaci općenito pokazuju da lakozamid ima mali interakcijski potencijal.
English: Second dose (in the evening)
Croatian: Druga doza (navečer)
English: This means that you should take care until you are used to the effects of this medicine.
Croatian: Stoga morate biti oprezni dok se ne priviknete na učinke ovog lijeka.
English: After intravenous administration, Cmax is reached at the end of infusion.
Croatian: Nakon intravenske primjene Cmax se postiže na kraju infuzije.
English: Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
Croatian: Simptomi uočeni nakon slučajnog ili namjernog predoziranja lakozamidom prvenstveno su povezani sa SŽS-om i gastrointestinalnim sustavom.
English: If multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued.
Croatian: Ako se sumnja na multiorgansku reakciju preosjetljivosti, primjenu lakozamida treba prekinuti.
English: The dose should be gradually increased until the optimum response is obtained.
Croatian: Dozu treba postupno povećavati dok se ne dobije optimalan odgovor.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications.
Croatian: Suicidalne ideacije i ponašanje prijavljeni su u bolesnika liječenih antiepileptičkim lijekovima u nekoliko indikacija.
English: Food does not affect the rate and extent of absorption.
Croatian: Hrana ne utječe na brzinu i opseg apsorpcije.
English: Hold the bottle upside down in one hand and use the other hand to fill the oral syringe.
Croatian: • Jednom rukom držite bocu okrenutu naopako, a drugom rukom napunite štrcaljku za usta.
English: Any unused solution should be discarded (see section 3).
Croatian: Svu neiskorištenu otopinu treba baciti (vidjeti dio 3).
English: When you change from the infusion to taking the medicine by mouth (or the other way around) the total amount you take each day and how often you take it stays the same.
Croatian: Kada s infuzije prijeđete na uzimanje lijeka kroz usta (ili obrnuto), ukupna količina koju uzimate svakog dana i učestalost uzimanja ostaju iste.
English: In the treated population, an increase in malformations has been noted with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Croatian: U liječenoj populaciji zabilježeno je povećanje malformacija pri politerapiji, međutim nije jasno u kojoj su mjeri odgovorni liječenje i/ili bolest.
English: The most frequent cardiac-related adverse reaction reported in elderly compared to the younger adult population was first-degree AV block.
Croatian: Najčešća nuspojava povezana sa srcem zabilježena u starijih u odnosu na mlađu odraslu populaciju bila je AV blok prvog stupnja.