FrancophonIA/ELRC3.0 huggingface dataset:
English: Lacosamide has minor to moderate influence on the ability to drive and use machines.
Croatian: Lakozamid malo do umjereno utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: Lacosamide did not affect the AUC of midazolam (metabolised by CYP3A4, lacosamide given 200 mg twice a day) but Cmax of midazolam was slightly increased (30 %).
Croatian: Lakozamid nije utjecao na AUC midazolama (metabolizira ga CYP3A4, lakozamid primijenjen 200 mg dvaput na dan) no Cmax midazolama bio je blago povišen (30 %).
English: In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.
Croatian: U istraživanjima interakcija lakozamid nije značajno utjecao na koncentracije karbamazepina i valproatne kiseline u plazmi.
English: This pack (treatment initiation pack) is used when you start your treatment with Lacosamide UCB.
Croatian: Ovo pakiranje (pakiranje za početak liječenja) se koristi kada započinjete
English: Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with these diluents and stored in glass or PVC bags.
Croatian: Kemijska i fizikalna stabilnost u primjeni dokazana je tijekom 24 sata na temperaturama do 25C za lijek pomiješan s navedenim otopinama i čuvan u staklu ili PVC vrećicama.
English: The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method.
Croatian: Procijenjene stope bolesnika sa 6-mjesečnim razdobljem bez napadaja bile su 89,8 % za bolesnike liječene lakozamidom i 91,1 % za bolesnike liječene karbamazepinom CR koristeći analizu po Kaplan-Meierovoj metodi.
English: Also, it is not known whether Lacosamide UCB passes into the breast milk.
Croatian: Također nije poznato izlučuje li se Lakozamid UCB u majčino mlijeko.
English: Lacosamide UCB tablets and syrup are bioequivalent.
Croatian: Lakozamid UCB tablete i sirup su bioekvivalentni.
English: Instructions for use are provided in the package leaflet.
Croatian: Upute za uporabu navedene su u uputi o lijeku.
English: Pull the piston down to the millilitre (ml) dose marker prescribed by your doctor (figure 8).
Croatian: • Povucite klip prema dolje do oznake za dozu u mililitrima (ml) koju je propisao Vaš liječnik
English: Each ml of solution for infusion contains 2.99 mg sodium.
Croatian: Jedan ml otopine za infuziju sadrži 2,99 mg natrija.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The dose is determined based on body weight.
Croatian: Djeca (od navršenih 4 godine života) i adolescenti tjelesne težine manje od 50 kg Doza se utvrđuje na temelju tjelesne težine.
English: Seek advice immediately from your doctor if you get pregnant or are planning to become pregnant.
Croatian: Odmah zatražite savjet svog liječnika ako ste trudni ili ako planirate imati dijete.
English: As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of lacosamide.
Croatian: Nakon odmjerne oznake za 1 ml svaka odmjerna oznaka odgovara volumenu od 0,25 ml, što je 2,5 mg lakozamida.
English: What you need to know before you take Lacosamide UCB
Croatian: Što morate znati prije nego počnete uzimati Lakozamid UCB
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite but the main contributing isoenzyme has not been confirmed in vivo.
Croatian: Podaci in vitro pokazuju da su CYP2C9, CYP2C19 i CYP3A4 sposobni katalizirati stvaranje Odezmetilnog metabolita, ali glavni izoenzim koji u tome sudjeluje nije potvrđen in vivo.
English: Ltd Τηλ: + 357 22 34 74 40
Croatian: Lifepharma (Z.A.M.) Ltd Τηλ: + 357 22 34 74 40
English: Carton of 56 film-coated tablets 150 mg (without Blue Box)
Croatian: Kutija s 56 filmom obloženih tableta 150 mg (bez plavog okvira)
English: If you stop taking Lacosamide UCB
Croatian: Ako prestanete uzimati Lakozamid UCB
English: Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Croatian: Ovisno o odgovoru i podnošljivosti, doza održavanja se svakih tjedan dana može dalje povećavati za 50 mg dvaput na dan (100 mg/dan) do maksimalne preporučene dnevne doze od 400 mg (200 mg dvaput na dan).
English: You have been given this medicine to lower the number of fits (seizures) you have.
Croatian: • Ovaj Vam je lijek dan za smanjenje broja napadaja.
English: For the full list of excipients, see section 6.1
Croatian: Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1
English: INFORMATION IN BRAILLE Lacosamide UCB 10 mg/ml (only for the outer carton)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lakozamid UCB 10 mg/ml (samo za kutiju)
English: Carton of 56 film-coated tablets 200 mg (without Blue Box)
Croatian: Kutija s 56 filmom obloženih tableta 200 mg (bez plavog okvira)
English: If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single “loading” dose of 200 mg (20 ml).
Croatian: Ako je Vaša tjelesna težina 50 kg ili veća, Vaš liječnik može odlučiti započeti liječenje lijekom Lakozamid UCB jednokratnom „udarnom“ dozom od 200 mg (20 ml).
English: Lacosamide UCB syrup contains sodium.
Croatian: Lakozamid UCB sirup sadrži natrij.
English: The treatment initiation pack is only suitable in adolescents and children weighing 50 kg or more and in adults.
Croatian: Pakiranje za početak liječenja prikladno je samo za adolescente i djecu tjelesne težine 50 kg ili više te odrasle.
English: In children weighing less than 20 kg, due to an increased clearance compared to adults, a maximum dose of up to 12 mg/kg/day is recommended.
Croatian: U djece tjelesne težine manje od 20 kg, zbog povećanog klirensa u odnosu na odrasle, preporučena je maksimalna doza od najviše 12 mg/kg/dan.
English: Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
Croatian: Ovisno o odgovoru i podnošljivosti, doza održavanja se svakih tjedan dana može dalje povećavati za 50 mg dvaput na dan (100 mg/dan) do maksimalne preporučene dnevne doze od 300 mg dvaput na dan (600 mg/dan).
English: Overall, the proportion of subjects with at least a 50 % reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was 52.9 % in the lacosamide group compared with 33.3 % in the placebo group.
Croatian: Ukupno je omjer ispitanika s barem 50 %-tnim smanjenjem djelomičnih pojava učestalosti napajada od 28 dana od početne točke do razdoblja održavanja bio 52,9 % u skupini koja je primala lakozamid u usporedbi s 33,3 % u skupini koja je primala placebo.
English: Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent.
Croatian: Lakozamid klinički značajno ne inhibira niti inducira CYP2C19 i CYP3A4.
English: Lacosamide therapy can be initiated with either oral or intravenous administration.
Croatian: Terapiju lakozamidom može se započeti bilo peroralnom bilo intravenskom primjenom.
English: (1) children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup.
Croatian: (1) Djeca i adolescenti tjelesne težine manje od 50 kg trebali bi započeti liječenje Lakozamid UCB 10 mg/ml sirupom.
English: Fall Skin laceration Contusion (1) Adverse reactions reported in post marketing experience.
Croatian: Pad Laceracije kože Kontuzije (1) Nuspojave prijavljene u razdoblju nakon stavljanja lijeka u promet.
English: No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric patients (CLCR > 30 ml/min).
Croatian: U odraslih i pedijatrijskih bolesnika s blagim do umjerenim oštećenjem bubrega ne treba prilagođavati dozu (CLCR > 30 ml/min).
English: Eligible patients on a stable dose regimen of 1 to ≤ 3 antiepileptic medicinal products, who still experienced at least 2 partial onset-seizures during the 4 weeks prior to screening with seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline period, were randomised to receive either placebo (n=172) or lacosamide (n=171).
Croatian: Podobni bolesnici na režimu stabilne doze od 1 do ≤ 3 antiepileptička lijeka koji su još uvijek iskusili najmanje 2 parcijalna napadaja tijekom 4 tjedna prije probira s razdobljima bez napadaja ne dulje od 21 dan u razdoblju od 8 tjedana prije ulaska u početno razdoblje, randomizirani su za primanje ili placeba (n=172) ili lakozamida (n=171).
English: Lacosamide UCB solution for infusion can be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated Ringer's solution.
Croatian: Lakozamid UCB otopina za infuziju se može primijeniti bez daljnjeg razrijeđenja ili se može razrijediti sa sljedećim otopinama: otopina natrijeva klorida 9 mg/ml (0,9 %), otopina glukoze 50 mg/ml (5 %) ili otopina Ringerovog laktata.
English: They will help you decide if you should use Lacosamide UCB or not.
Croatian: Liječnik će Vam pomoći u donošenju odluketrebate li upotrebljavati Lakozamid UCB ili ne.
English: A maximum dose of 250 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease.
Croatian: Maksimalna doza od 250 mg/dan preporučuje se za pedijatrijske bolesnike tjelesne težine jednake ili veće od 50 kg i za odrasle bolesnike s teškim oštećenjem bubrega (CLCR ≤ 30 ml/min) ili za bolesnike sa završnim stadijem bubrežne bolesti.
English: EU/1/19/1383/010 EU/1/19/1383/011 EU/1/19/1383/012 EU/1/19/1383/013 EU/1/19/1383/014 EU/1/19/1383/015 EU/1/19/1383/016 EU/1/19/1383/017 EU/1/19/1383/018 EU/1/19/1383/019 EU/1/19/1383/020 EU/1/19/1383/021 EU/1/19/1383/022 EU/1/19/1383/023 EU/1/19/1383/024 EU/1/19/1383/025 EU/1/19/1383/026 EU/1/19/1383/027
Croatian: EU/1/19/1383/004 EU/1/19/1383/005 EU/1/19/1383/006 EU/1/19/1383/007 EU/1/19/1383/008 EU/1/19/1383/009 EU/1/19/1383/010 EU/1/19/1383/011 EU/1/19/1383/012 EU/1/19/1383/013 EU/1/19/1383/014 EU/1/19/1383/015 EU/1/19/1383/016 EU/1/19/1383/017 EU/1/19/1383/018 EU/1/19/1383/019 EU/1/19/1383/020 EU/1/19/1383/021 EU/1/19/1383/022 EU/1/19/1383/023 EU/1/19/1383/024 EU/1/19/1383/025 EU/1/19/1383/026 EU/1/19/1383/027
English: Common: may affect up to 1 in 10 children
Croatian: Često: mogu se javiti u do 1 na 10 djece
English: Your doctor may also prescribe a starting dose of 100 mg (10 ml) of Lacosamide UCB twice a day.
Croatian: Vaš liječnik također može propisati početnu dozu od 100 mg (10 ml) lijeka Lakozamid UCB dvaput na dan.
English: This is because we do not yet know whether it will work and whether it is safe for children in this age group.
Croatian: Lakozamid UCB se ne preporučuje za djecu mlađu od 4 godine zato što još nije poznato je li djelotvoran i siguran za djecu u toj dobnoj skupini.
English: If you have missed a dose within the first 6 hours of the scheduled dose, take it as soon as you remember.
Croatian: • Ako primijetite da ste propustili dozu, a od propuštene doze je proteklo manje od 6 sati, dozu uzmite čim se sjetite.
English: Diluents: sodium chloride 9 mg/ml (0.9 %) solution for injection glucose 50 mg/ml (5 %) solution for injection lactated Ringer's solution for injection.
Croatian: 0,9 %-tna (9 mg/ml) otopina natrijeva klorida za injekciju 5 % -tna (50 mg/ml) otopina glukoze za injekciju otopina Ringerovog laktata za injekciju.
English: The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2).
Croatian: Farmakokinetika lakozamida nije ispitana u bolesnika s teškim oštećenjem jetre (vidjeti dio 5.2).
English: Lacosamide is less than 15 % bound to plasma proteins.
Croatian: Manje od 15 % lakozamida se veže na proteine.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 10 mg lacosamide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml otopine za infuziju sadrži 10 mg lakozamida.
English: Each vial contains 20 ml.
Croatian: Jedna bočica sadrži 20 ml.
English: Ventricular tachyarrhythmia (1)
Croatian: Ventrikularna tahiaritmija(1)
English: In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended.
Croatian: U pedijatrijskih bolesnika tjelesne težine manje od 50 kg s teškim oštećenjem bubrega (CLCR ≤ 30 ml/min) i u bolesnika sa završnim stadijem bubrežne bolesti preporučuje se smanjenje maksimalne doze za 25 %.
English: Being sick (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or bowel, diarrhoea;
Croatian: • povraćanje, suha usta, zatvor, probavne tegobe, prekomjerna nadutost u želucu ili crijevima,
English: What Lacosamide UCB contains
Croatian: Što Lakozamid UCB sadrži
English: Lacosamide film-coated tablets are for oral use.
Croatian: Lakozamid filmom obložene tablete namijenjene su peroralnoj primjeni.
English: Maximum recommended dose: 0.4 ml/kg
Croatian: Maksimalna preporučena doza: 0,4 ml/kg
English: Using Lacosamide UCB on its own - This is for information only.
Croatian: Kada se primjenjuje samo Lakozamid UCB- ovo je samo informativno.
English: After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (for example 4 graduation marks corresponds to 10 mg).
Croatian: Nakon toga, svaka odmjerna oznaka (0,25 ml) odgovara 2,5 mg lakozamida (na primjer, 4 odmjerne oznake odgovaraju 10 mg).
English: Carton of 168 film-coated tablets containing 3 Cartons of 56 film-coated tablets (with Blue box)
Croatian: Kutija sa 168 filmom obloženih tableta koja sadrži 3 kutije s 56 filmom obloženih tableta (s plavim okvirom)
English: Week 2
Croatian: DRUGO 2. tjedan
English: Maximum recommended dose in patients < 40 kg up to 12 mg/kg/day Maximum recommended dose in patients ≥ 40 kg to < 50 kg up to 10 mg/kg/day
Croatian: Maksimalna preporučena doza u bolesnika < 40 kg do 12 mg/kg/dan Maksimalna preporučena doza u bolesnika ≥ 40 kg do < 50 kg do 10 mg/kg/dan
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %),
Croatian: Sigurnosni profil lakozamida u placebom kontroliranim (vidjeti pojedinosti o ispitivanju u dijelu 5.1) i otvorenim ispitivanjima (n=408) u dodatnoj terapiji u djece u dobi od navršene 4 godine starosti podudarao se sa sigurnosnim profilom zabilježenim u odraslih iako je učestalost nekih nuspojava (somnolencija, povraćanje i konvulzije) bila povećana i prijavljene su dodatne nuspojave (nazofaringitis, pireksija, faringitis, smanjenje teka, letargija i abnormalno ponašanje) u pedijatrijskih bolesnika: nazofaringitis (15,7 %), povraćanje (14,7%), somnolencija (14,0 %), omaglica (13,5 %),
English: The percent reduction over placebo based on analysis of covariance was 31.72 % (95 % CI: 16.342,44.277).
Croatian: Postotno smanjenje u odnosu na analizu kovarijance temeljenu na placebu između lakozamida i placebo skupine bilo je 31,72 % (95 % CI: 16,342; 44,277).
English: On the first day of treatment the patient starts with Lacosamide UCB 50 mg tablets twice a day.
Croatian: Prvog dana liječenja bolesnik započinje s Lakozamid UCB tabletom od 50 mg dvaput na dan.
English: What Lacosamide UCB is used for
Croatian: Za što se Lakozamid UCB koristi
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, the extent of increase in PR interval was comparable between lacosamide and carbamazepine.
Croatian: U kliničkom ispitivanju monoterapije u kojem je lakozamid uspoređivan s karbamazepinom CR, stupanj produljenja PR intervala bio je usporediv između lakozamida i karbamazepina.
English: Dosing was initiated at a dose of 2 mg/kg/day in subjects weighing less than 50 kg or 100 mg/day in subjects weighing 50 kg or more in 2 divided doses.
Croatian: Doziranje je započelo s dozom od 2 mg/kg/dnevno u ispitanika s tjelesnom težinom manjom od 50 kg ili od 100 mg/dnevno u ispitanika s tjelesnom težinom od 50 kg ili većom u 2 odvojene doze.
English: If you have any questions, please go back to your doctor or pharmacist.
Croatian: Ako imate bilo kakvih pitanja, ponovno se obratite svom liječniku ili ljekarniku.
English: It is unknown whether lacosamide is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se lakozamid u majčino mlijeko u ljudi.
English: Maximum recommended dose: 0.5 ml/kg
Croatian: Maksimalna preporučena doza: 0,5 ml/kg
English: Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Croatian: Višestruka pakiranja koja sadrže 168 (3 pakiranja s 56 tableta) filmom obloženih tableta u PVC/PVDC blisteru, zatvorenom aluminijskom folijom.
English: Angioedema(1) Urticaria(1)
Croatian: Angioedem(1) Urtikarija(1)
English: Adolescents and children weighing 50 kg or more and adults Use the measuring cup provided in the carton box.
Croatian: Adolescenti i djeca tjelesne težine 50 kg ili više i odrasli • Upotrebljavajte mjernu čašu isporučenu u kartonskoj kutiji.
English: Conversion to or from oral and intravenous administration can be done directly without titration.
Croatian: S peroralne na intravensku primjenu, i obratno, može se prijeći izravno bez titracije.
English: Warnings and precautions Talk to your doctor before taking Lacosamide UCB if: you have thoughts of harming or killing yourself.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Lakozamid UCB:
English: 1 bottle of 200 ml contains 2,000 mg lacosamide.
Croatian: 1 boca od 200 ml sadrži 2000 mg lakozamida.
English: Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg.
Croatian: Udarna doza se ne preporučuje u adolescenata i djece tjelesne težine manje od 50 kg.
English: Film-coat: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), colourants*.
Croatian: Film ovojnica: poli(vinilni alkohol), polietilenglikol, talk, titanijev dioksid (E171), bojila* * Bojila su:
English: you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation or atrial flutter).
Croatian: • ako imate srčani problem koji utječe na srčani ritam i često imate osobito usporene, ubrzane ili nepravilne otkucaje srca (kao što su AV blok, treperenje pretklijetki i lepršanje pretklijetki).
English: In vitro data show that CYP2C9, CYP2C19 and CYP3A4 are capable of catalysing the formation of the O-desmethyl metabolite.
Croatian: Podaci in vitro pokazuju da su CYP2C9, CYP2C19 i CYP3A4 sposobni katalizirati stvaranje
English: The oral bioavailability of lacosamide tablets is approximately 100 %.
Croatian: Bioraspoloživost lakozamida nakon peroralne primjene je otprilike 100 %.
English: If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR the extent of increase in PR interval was comparable between lacosamide and carbamazepine.
Croatian: U kliničkom ispitivanju monoterapije u kojem je lakozamid uspoređivan s karbamazepinom CR stupanj produljenja PR intervala bio je usporediv između lakozamida i karbamazepina.
English: Adolescents and children weighing 50 kg or more and adults
Croatian: Adolescenti i djeca tjelesne težine 50 kg ili više i odrasli
English: Lacosamide UCB 10 mg/ml solution for infusion is a clear, colourless solution.
Croatian: • Lakozamid UCB 10 mg/ml otopina za infuziju je bistra, bezbojna otopina.
English: The following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults.
Croatian: U sljedećoj je tablici sažeto prikazano preporučeno doziranje za adolescente i djecu tjelesne težine od 50 kg ili više, te za odrasle.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER UCB Pharma S.A.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET UCB Pharma S.A.
English: If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed syrup anymore.
Croatian: • Ako je od propuštene doze protekloviše od 6 sati, nemojte uzimati propušteni sirup.
English: Week 1
Croatian: DRUGO 1. tjedan
English: 2 mg/kg/day
Croatian: 2 mg/kg/dan
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Croatian: StevensJohnsonov sindrom(1)
English: Week 4 Package marked "Week 4"
Croatian: 4. tjedan Pakiranje označeno "4. tjedan "
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Croatian: Sigurnosni profil lakozamida u placebom kontroliranim (vidjeti pojedinosti o ispitivanju u dijelu 5.1) i otvorenim ispitivanjima (n=408) u dodatnoj terapiji u djece u dobi od navršene 4 godine starosti podudarao se sa sigurnosnim profilom zabilježenim u odraslih iako je učestalost nekih nuspojava (somnolencija, povraćanje i konvulzije) bila povećana i prijavljene su dodatne nuspojave (nazofaringitis, pireksija, faringitis, smanjenje teka, letargija i abnormalno ponašanje) u pedijatrijskih bolesnika: nazofaringitis (15,7 %), povraćanje (14,7%), somnolencija (14,0 %), omaglica (13,5 %), pireksija (13,0 %), konvulzije (7,8 %), smanjenje teka (5,9 %), faringitis (4,7 %), letargija (2,7 %) i abnormalno ponašanje (1,7 %).
English: Take the oral syringe out of the adaptor (figure 10).
Croatian: • Izvadite štrcaljku za usta iz nastavka (slika 10).
English: Itching, rash.
Croatian: • svrbež, osip.
English: Take off the adaptor from the oral syringe (figure 2).
Croatian: • Skinite nastavak sa štrcaljke za usta (slika 2).
English: Lacosamide UCB solution for infusion can be administered intravenously without further dilution or can be diluted with sodium chloride 9 mg/ml (0.9 %) solution for injection, glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution for injection.
Croatian: Lakozamid UCB otopina za infuziju se može primijeniti intravenski bez dodatnog razrjeđivanja ili se može razrijediti s otopinom natrijevog klorida za injekciju 9 mg/ml (0,9 %), otopinom glukoze za injekciju 50 mg/ml (5 %) ili otopinom Ringerovog laktata za injekciju.
English: The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above.
Croatian: • Mjerna čaša prikladna je za odrasle, adolescente i djecu tjelesne težine 50 kg ili više.
English: For precautionary measures, breast-feeding should be discontinued during treatment with lacosamide.
Croatian: Zbog mjera opreza tijekom liječenja lakozamidom dojenje treba prekinuti.
English: Do not take Lacosamide UCB if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na lakozamid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).