FrancophonIA/ELRC3.0 huggingface dataset:
English: • The CHMP noted that the product information for the different auto-injectors would benefit from an update to include warnings and precautions on uncertainties in whether a single administration would suffice for any given episode and advise that patients are prescribed two pens which they should carry at all times, training of immediate associates of patients and inclusion of information on the needle length.
Croatian: • je CHMP zaključio kako bi informacije o proizvodu za različite automatske brizgalice imale koristi od ažuriranja kojim bi se uključila upozorenja i mjere opreza o nesigurnostima vezanima uz dostatnost jedne primjene za navedene epizode i savjet da se bolesnicima trebaju propisivati dvije brizgalice koje trebaju nositi u svakom trenutku, obuku neposredno povezanih osoba s bolesnicima i uključenje informacija o dužini igle.
English: 2 F. Estelle R. Simons, MD, FRCPC, Xiaochen Gu, PhD, and Keith J. Simons, PhD. Epinephrine absorption in adults:
Croatian: 2 F. Estelle R. Simons, MD, FRCPC, Xiaochen Gu, PhD, and Keith J. Simons, PhD.
English: 1 F. Estelle R. Simons, MD, FRCPC, Janet R Roberts, MD, FRCPC, Xiaochen Gu, PhD, and Keith J. Simons, PhD. Epinephrine absorption in children with a history of anaphylaxis.
Croatian: 1 F. Estelle R. Simons, MD, FRCPC, Janet R Roberts, MD, FRCPC, Xiaochen Gu, PhD, and Keith J. Simons, PhD.
English: The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the conditions to the marketing authorisations and taking into account the amendments to the product information and other risk minimisation measures recommended.
Croatian: CHMP je zaključio da omjer koristi i rizika za automatsku brizgalicu za adrenalin ostaje povoljan, što je predmetom uvjeta za izdavanje odobrenja za stavljanje lijeka u promet i uzimajući u obzir izmjene u informacijama o proizvodu kao i ostale preporučene mjere za smanjivanje rizika.
English: Bhalla, M.C., B.D.
Croatian: Bhalla, M.C., B.D. Gable, J.A. Frey, M.R.
English: Gable, J.A.
Croatian: Frey, M.R.
English: The CHMP also concluded on the need for a PK/PD study to be conducted in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device.
Croatian: CHMP je također zaključio da postoji potreba za uključivanjem PK/PD ispitivanja kako bi se razumio utjecaj različitih čimbenika za distribuciju, izlaganje i djelovanje adrenalina u slučaju primjene putem automatske brizgalice za adrenalin.
English: The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the agreed changes to the product information and the above-mentioned additional risk minimisation measures.
Croatian: CHMP je zaključio da omjer koristi i rizika za automatsku brizgalicu za adrenalin ostaje pozitivan, te je predmetom usuglađenih izmjena u informacijama o lijeku i prethodno navedene dodatne mjere za smanjivanje rizika.
English: Daniel C. Bewick, MD, Neville B. Wright, MD, Richard S. Pumphrey, MD, Peter D. Arkwright, MD, DPhil.
Croatian: Bewick, MD, Neville B. Wright, MD, Richard S.
English: <ANNEX IV
Croatian: <PRILOG IV.
English: Marketing authorisation under exceptional circumstances
Croatian: Odobrenje za stavljanje lijeka u promet u iznimnim okolnostima
English: [ For the status on marketing authorisation under exceptional circumstances and, in case of similarity and an accepted derogation, please select the statement(s) as provided below.]
Croatian: For the status on marketing authorisation under exceptional circumstances and, in case of for similarity and an accepted derogation, please select the statement(s) as provided below.]
English: <one-year <marketing protection> <data exclusivity>>
Croatian: <Jednogodišnja <zaštita stavljanja lijeka u promet> <zaštita podataka o lijeku>>
English: CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND <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 DAVANJU ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA TE <SLIČNOSTI I ODSTUPANJU> <I> <ZAHTJEVU ZA JEDNOGODIŠNJU <ZAŠTITU STAVLJANJA LIJEKA U PROMET> <ZAŠTITU PODATAKA O LIJEKU>>
English: <The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.>
Croatian: <Nakon razmatranja zahtjeva, mišljenje je CHMP-a da je omjer rizika i koristi povoljan te se može preporučiti davanje odobrenja za stavljanje lijeka u promet u iznimnim okolnostima, što je dodatno pojašnjeno u Europskom javnom izvješću o ocjeni lijeka.>
English: <The CHMP is of the opinion that pursuant to Article 8 of Regulation (EC) No. 141/2000 and <Article 3 of Commission Regulation (EC) No 847/2000> [only for the superiority derogation] the following derogation
 laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report :
Croatian: 3 Uredbe Komisije (EZ) br. 847/2000> [only for the superiority derogation] primjenjuje(u) sljedeće(a) odstupanje(a) navedeno(a) u čl. 8.3 iste Uredbe, 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: These reactions resolve without treatment in 2 to 5 days.
Croatian: Te reakcije nestaju bez ikakve terapije u roku od 2 do 5 dana.
English: Protection starts at the beginning of pregnancy and lasts for 6 months.
Croatian: Zaštita započinje na početku graviditeta i traje šest mjeseci.
English: If the animals come into contact with the virus the immune system will be able to respond quickly.
Croatian: Ako životinje budu izložene virusu, imunosni sustav moći će brzo reagirati.
English: An increase in body temperature can occur after vaccination (which may affect up to 1 in 10 animals) but this resolves within 24 to 48 hours.
Croatian: Nakon cijepljenja može doći do povećanja tjelesne temperature (može se javiti u do 1 na 10 životinja), no ta nuspojava nestaje u roku od 24 do 48 sati.
English: The initial vaccination course is two injections given 3 weeks apart, with the second injection given at least 3 weeks before mating.
Croatian: Početni ciklus cijepljenja sastoji se od dvije injekcije koje se daju u razmaku od tri tjedna, pri čemu se druga injekcija daje barem tri tjedna prije parenja.
English: Further information on ReproCyc ParvoFLEX can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
Croatian: Više informacija o VMP-u ReproCyc ParvoFLEX nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/veterinary/EPAR/reprocyc-parvoflex.
English: It is given into the muscle of female pigs from 5 months of age.
Croatian: Daje se u mišić ženki svinja u dobi od 5 mjeseci ili starijima.
English: A single booster injection can be given every 6 months to maintain immunity.
Croatian: Radi zadržavanja imuniteta može se provesti docjepljivanje jednom injekcijom svakih šest mjeseci.
English: The vaccine contains a porcine parvovirus protein that does not cause disease.
Croatian: Cjepivo sadržava protein parvovirusa svinja koji ne uzrokuje bolest.
English: The withdrawal period for meat from pigs treated with ReproCyc ParvoFLEX is ‘zero' days, which means that there is no mandatory waiting time.
Croatian: Razdoblje karencije za meso svinja liječenih VMP-om ReproCyc ParvoFLEX iznosi „nula” dana, drugim riječima, nema obveznog razdoblja čekanja.
English: This will help protect the unborn piglets against porcine parvovirus infections during pregnancy.
Croatian: To će pomoći zaštititi nerođenu prasad od infekcija parvovirusom svinja za vrijeme graviditeta.
English: The most common side effect with ReproCyc ParvoFLEX (which may affect more than 1 in 10 animals) is short lived redness or swelling (up to 4 cm) at the injection site.
Croatian: Najčešća je nuspojava VMP-a ReproCyc ParvoFLEX (može se javiti u više od 1 na 10 životinja) kratkotrajno crvenilo ili oteklina (veličine do 4 cm) na mjestu primjene injekcije.
English: ReproCyc ParvoFLEX also contains the adjuvant (ingredient that strengthens the immune response) carbomer.
Croatian: ReproCyc ParvoFLEX sadržava i adjuvans (sastojak koji jača imunosni odgovor) karbomer.
English: ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine) EMA/153444/2019
Croatian: ReproCyc ParvoFLEX (inaktivirano cjepivo protiv parvoviroze svinja) EMA/245841/2019
English: When ReproCyc ParvoFLEX is given to female pigs the animals' immune system recognises the viral protein as ‘foreign' and makes antibodies against it.
Croatian: Kada se ReproCyc ParvoFLEX daje ženkama svinja, imunosni sustav životinja prepoznaje virusni protein kao „strano tijelo” te proizvodi protutijela protiv njega.
English: ReproCyc ParvoFLEX (inactivated porcine parvovirosis vaccine)
Croatian: ReproCyc ParvoFLEX (inaktivirano cjepivo protiv parvoviroze svinja)
English: The European Medicines Agency decided that ReproCyc ParvoFLEX's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka ReproCyc ParvoFLEX nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: ReproCyc ParvoFLEX contains inactivated (killed) porcine parvovirus strain 27a viral protein 2.
Croatian: ReproCyc ParvoFLEX sadrži inaktivirani (umrtvljeni) parvovirus svinja, soj 27a, virusni protein 2.
English: Three laboratory studies showed that ReproCyc ParvoFLEX protects against transplacental porcine parvovirus infection, since more than 95% of piglets from vaccinated female pigs were protected from infection, as shown by absence of parvovirus.
Croatian: U trima laboratorijskim ispitivanjima utvrđeno je da ReproCyc ParvoFLEX štiti od transplacentalne infekcije uzrokovane parvovirusom svinja jer je više od 95 % prasadi cijepljenih ženki svinja bilo zaštićeno od infekcije, što se utvrdilo na temelju odsutnosti parvovirusa.
English: Other information about ReproCyc ParvoFLEX
Croatian: Ostale informacije o VMP-u ReproCyc ParvoFLEX
English: ReproCyc ParvoFLEX is a vaccine.
Croatian: ReproCyc ParvoFLEX je cjepivo.
English: ReproCyc ParvoFLEX can only be obtained with a prescription and is available as an injection.
Croatian: ReproCyc ParvoFLEX izdaje se samo na veterinarski recept i dostupan je u obliku injekcije.
English: A field study in Spain showed that ReproCyc ParvoFLEX, when given to female pigs, was as effective as an authorised porcine parvovirus vaccine, Parvoseng, as measured by the fertility of vaccinated animals, the number of still births and the size of the litters.
Croatian: Terenskim ispitivanjem u Španjolskoj utvrđeno je da je ReproCyc ParvoFLEX, kad je davan ženkama svinja, bio jednako učinkovit kao i odobreno cjepivo protiv parvovirusa svinja, Parvoseng, u pogledu plodnosti cijepljenih životinja, prašenja mrtve prasadi i broja prasadi u leglu.
English: ReproCyc ParvoFLEX is a veterinary vaccine given to female pigs to protect their unborn piglets from porcine parvovirus infection via the placenta.
Croatian: ReproCyc ParvoFLEX veterinarsko je cjepivo koje se daje ženkama svinja radi zaštite njihove nerođene prasadi od transplacentalne infekcije uzrokovane parvovirusom svinja.
English: Why is ReproCyc ParvoFLEX authorised in the EU?
Croatian: Zašto je ReproCyc ParvoFLEX odobren u EU-u?
English: An overview of ReproCyc ParvoFLEX and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u ReproCyc ParvoFLEX i zašto je odobren u EU-u
English: For more information about using ReproCyc ParvoFLEX, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a ReproCyc ParvoFLEX pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: What is ReproCyc ParvoFLEX and what is it used for?
Croatian: Što je ReproCyc ParvoFLEX i za što se primjenjuje?
English: What are the risks associated with ReproCyc ParvoFLEX?
Croatian: Koji su rizici povezani s VMP-om ReproCyc ParvoFLEX?
English: Porcine parvovirus causes infertility, still births and small litters in female pigs.
Croatian: Parvovirus svinja u ženki svinja uzrokuje neplodnost, prašenje mrtve prasadi i smanjen broj prasadi u leglu.
English: How does ReproCyc ParvoFLEX work?
Croatian: Kako djeluje ReproCyc ParvoFLEX?
English: What benefits of ReproCyc ParvoFLEX have been shown in studies?
Croatian: Koje su koristi od VMP-a ReproCyc ParvoFLEX utvrđene u ispitivanjima?
English: How is ReproCyc ParvoFLEX used?
Croatian: Kako se ReproCyc ParvoFLEX primjenjuje?
English: ReproCyc ParvoFLEX received a marketing authorisation valid throughout the EU on 26 April 2019.
Croatian: Lijek ReproCyc ParvoFLEX dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji
English: Patients should be monitored at least every six months.
Croatian: Bolesnike je potrebno pratiti barem svakih šest mjeseci.
English: Further information on Nityr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Nityr nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nityr (nitisinone)
Croatian: Nityr (nitizinon)
English: Nityr (nitisinone) EMA/396203/2018
Croatian: Nityr (nitizinon) EMA/396203/2018
English: Nityr is intended for long-term use.
Croatian: Nityr je namijenjen za dugoročnu primjenu.
English: Tyrosine is broken down in the body by a number of enzymes.
Croatian: Tirozin se u tijelu razgrađuje pomoću više enzima.
English: What measures are being taken to ensure the safe and effective use of Nityr?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nityr?
English: Patients with HT-1 lack one of these enzymes, so tyrosine is not properly eliminated but is converted into harmful substances.
Croatian: Bolesnicima koji imaju HT-1 nedostaje jedan od tih enzima pa se tiroksin ne može pravilno ukloniti nego se pretvara u štetne tvari.
English: This is a rare disease in which the body is unable to completely break down the amino acid tyrosine and, as a result, harmful substances are formed, causing serious liver problems and liver cancer.
Croatian: To je rijetka bolest u kojoj tijelo ne može potpuno razgraditi aminokiselinu tirozin te se posljedično stvaraju štetne tvari koje uzrokuju ozbiljne tegobe s jetrom i rak jetre.
English: As for every medicine, the company provided studies on the quality of Nityr.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Nityr.
English: Nityr is available as 10 mg tablets to be taken by mouth.
Croatian: Nityr je dostupan u obliku tableta od 10 mg koje se uzimaju na usta.
English: What are the benefits and risks of Nityr?
Croatian: Koje su koristi i rizici od lijeka Nityr?
English: Treatment should be started as early as possible and the dose of Nityr adjusted according to the patient's response and body weight.
Croatian: Liječenje treba započeti što prije, a dozu lijeka Nityr prilagoditi prema bolesnikovoj reakciji i tjelesnoj težini.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nityr.
Croatian: Ispitivanja koristi i rizika od djelatne tvari u odobrenoj primjeni već su provedena s referentnim lijekom Orfadin i stoga ih nije potrebno ponavljati za lijek Nityr.
English: Nityr can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Croatian: Nityr se izdaje samo na liječnički recept, a terapiju smiju započeti i pratiti samo liječnici s iskustvom u liječenju bolesnika koji imaju HT-1.
English: This means that Nityr contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Orfadin.
Croatian: To znači da Nityr sadržava istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Orfadin.
English: What is Nityr and what is it used for?
Croatian: Što je Nityr i za što se primjenjuje?
English: Nityr is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Croatian: Nityr se koristi za liječenje nasljedne tirozinemije tipa 1 (HT-1).
English: Side effects reported with Nityr are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Nityr pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Nityr authorised in the EU?
Croatian: Zašto je lijek Nityr odobren u EU-u?
English: Because Nityr 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 Nityr generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: However, as the unconverted tyrosine remains in the body during Nityr treatment, patients need to eat
Croatian: Međutim, kako nepromijenjeni tirozin ostaje u tijelu tijekom terapije lijekom Nityr, bolesnici moraju biti na posebnoj prehrani koja sadrži
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nityr have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Nityr nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Other information about Nityr
Croatian: Ostale informacije o lijeku Nityr
English: An overview of Nityr and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Nityr i zašto je odobren u EU-u
English: The European Medicines Agency concluded that, in accordance with EU requirements, Nityr has been shown to have comparable quality and to be bioequivalent to Orfadin.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Nityr posjeduje usporedivu kakvoću te da je bioekvivalentan s lijekom Orfadin.
English: The active substance in Nityr, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Croatian: Djelatna tvar u lijeku Nityr, nitizinon, blokira enzim koji pretvara tirozin u štetne tvari.
English: For more information about using Nityr, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Nityr, pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku
English: As for all medicines, data on the use of Nityr are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Nityr kontinuirano se prate.
English: Nityr is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Croatian: Nityr se primjenjuje u kombinaciji s prehranom s ograničenim unosom aminokiselina tirozin i fenilalanin.
English: Nityr contains the active substance nitisinone and is a ‘generic medicine'.
Croatian: Nityr sadrži djelatnu tvar nitizinon te je „generički lijek”.
English: The diet also needs to be low in phenylalanine, as this is converted to tyrosine in the body.
Croatian: Prehrana treba sadržavati i male količine fenilalanina jer se on u tijelu pretvara u tirozin.
English: Therefore, the Agency's view was that, as for Orfadin, the benefit of Nityr outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Nityr, kao i od lijeka Orfadin, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: How does Nityr work?
Croatian: Kako djeluje Nityr?
English: How is Nityr used?
Croatian: Kako se Nityr koristi?
English: How has Nityr been studied?
Croatian: Kako je Nityr ispitivan?
English: a special diet low in tyrosine.
Croatian: male količine tirozina.
English: • Try to take it at about the same time each day.
Croatian: • Nastojte ga uzimati u otprilike isto vrijeme svakog dana.
English: Eating less than usual;
Croatian: jedu manje nego obično.
English: You may experience:
Croatian: Možda ćete doživjeti:
English: Date of first authorisation: 18 September 2017
Croatian: Datum prvog odobrenja: 18. rujna 2017
English: The duration of the treatment was up to 121 weeks depending on the response.
Croatian: Liječenje je trajalo do 121 tjedna, ovisno o odgovoru.
English: This presentation is not suitable for this category of patients.
Croatian: Ovo pakiranje nije prikladno za tu kategoriju bolesnika.
English: • Lacosamide Accord may be used on its own or with other antiepileptic medicines.
Croatian: • Lakozamid Accord se može koristiti samostalno ili s drugim antiepileptičkim lijekovima.
English: Week Package to be used
Croatian: Tjedan Pakiranje koje se koristi
English: Abnormal thinking or losing touch with reality;
Croatian: • neuobičajeno razmišljanje ili gubitak veze sa stvarnošću;
English: Maintenance treatment (after the first 4 weeks)
Croatian: Održavanje liječenja (nakon prva 4 tjedna)
English: If you are allergic to peanut or soya, do not use this medicinal product.
Croatian: Ako ste alergični na kikiriki ili soju, nemojte koristiti ovaj lijek.
English: Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
Croatian: Liječnik može propisati drugačiju dozu ako imate problema s bubrezima ili jetrom.
English: • medicines to treat heart problems;
Croatian: • lijekovi za liječenje srčanih problema;
English: The dose is determined based on body weight.
Croatian: Doza se utvrđuje na temelju tjelesne težine.
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: Do not take Lacosamide Accord if any of the above applies to you.
Croatian: Nemojte uzimati Lakozamid Accord ako se na Vas odnosi bilo koja od gornjih tvrdnji.
English: You should continue to take Lacosamide Accord until your doctor tells you to stop.
Croatian: Lakozamid Accord morate nastaviti uzimati sve dok Vam liječnik ne odredi da prestanete.
English: • you are often dizzy or fall over.
Croatian: • ako često imate omaglicu ili padate.
English: Risk related to epilepsy and antiepileptic medicinal products in general
Croatian: Rizik povezan s epilepsijom i antiepileptici općenito
English: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Croatian: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ujedinjeno Kraljevstvo ili
English: • Do not stop taking Lacosamide Accord without talking to your doctor, as your epilepsy may come back again or become worse.
Croatian: • Ne prekidajte uzimanje Lakozamid Accorda bez savjetovanja s liječnikom jer bi se epilepsija mogla ponovno pojaviti ili pogoršati.
English: Each package contains a different dosage strength of Lacosamide Accord, so you will increase your dose gradually.
Croatian: Svako pakiranje sadrži drugu jačinu doze Lakozamid Accorda, tako da ćete Vašu dozu postupno povećavati.
English: Instead take Lacosamide Accord at the next time that you would normally take it.
Croatian: Umjesto toga, uzmite Lakozamid Accord u sljedeće vrijeme kada ga uobičajeno uzimate.