FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare: Exfoliative dermatitis 2) 2) Cases were reported in patients with psoriasis diagnosis
Croatian: Eksfolijativni dermatitis 2) 2) Prijavljeni su slučajevi u bolesnika s dijagnosticiranom psorijazom
English: Caution should be exercised in the interpretation of these laboratory results in patients who are receiving sulfasalazine.
Croatian: Potrebno je pažljivo tumačiti te laboratorijske rezultate u bolesnika koji primaju sulfasalazin.
English: Tell your doctor, or seek medical attention immediately if you have the following side effects: Frequency not known (cannot be estimated from the available data): - Inflammation of the eye (uveitis) with symptoms such as eye redness, pain, sensitivity to light, runny eyes, seeing small dots or getting blurred vision
Croatian: Obavijestite svojeg liječnika ili odmah potražite medicinsku pomoć ako se pojave sljedeće nuspojave: Učestalost nepoznata (ne može se procijeniti iz dostupnih podataka): - Upala oka (uveitis) sa simptomima kao što su crvenilo oka, bol, osjetljivost na svjetlost, suzne oči, točkice u vidnom polju ili zamagljen vid
English: Examples of such assays may include urea, ammonia, LDH, α-HBDH and glucose.
Croatian: Primjeri takvih testova mogu uključivati ureu, amonijak, LDH, α-HBDH i glukozu.
English: • redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
Croatian: • crvenilo i ljuštenje kože na većem dijelu tijela, koje može biti popraćeno svrbežom ili bolom (eksfolijativni dermatitis)
English: What you need to know before you take sulfasalazine Tell your doctor if you are taking or have recently taken [Product name], or any other sulfasalazine containing products, because they may affect results of blood and urine tests.
Croatian: Što morate znati prije nego počnete uzimati sulfasalazin Obavijestite svojeg liječnika ako uzimate ili ste nedavno uzeli [naziv lijeka] ili bilo koji drugi lijek koji sadrži sulfasalazin jer oni mogu utjecati na rezultate krvnih pretraga i testova mokraće.
English: Women of childbearing potential should be informed about the potential risks of propylthiouracil use during pregnancy.
Croatian: Žene reproduktivne dobi potrebno je obavijestiti o potencijalnim rizicima uporabe propiltiouracila tijekom trudnoće.
English: Epidemiological studies provide conflicting results regarding the risk of congenital malformations.
Croatian: Epidemiološka ispitivanja ne pružaju nedvojbene rezultate u pogledu rizika od kongenitalnih malformacija.
English: It is possible that alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase-muscle/brain (CK-MB), glutamate dehydrogenase (GLDH), or thyroxine may also show interference when sulfasalazine treatment is given at high doses.
Croatian: Moguće je da alanin aminotransferaza (ALT), aspartat aminotransferaza (AST), kreatin-kinaza mišića/mozga (CK-MB), glutamat dehidrogenaza (GLDH) ili tiroksin također pokažu interferenciju ako se liječenje sulfasalazinom primijeni u velikim dozama.
English: Special warnings and precautions for use […] Overdose can unmask existing Brugada syndrome.
Croatian: Posebna upozorenja i mjere opreza pri uporabi […] Predoziranjem se može otkriti postojeći Brugada sindrom.
English: Sulfasalazine or its metabolites may interfere with ultraviolet absorbance, particularly at 340 nm, and may cause interference with some laboratory assays that use NAD(H) or NADP(H) to measure ultraviolet absorbance around that wavelength.
Croatian: Sulfasalazin ili njegovi metaboliti mogu interferirati s ultraljubičastom apsorbancijom, posebice pri 340 nm, te mogu uzrokovati interferenciju s nekim laboratorijskim testovima koji za mjerenje ultraljubičaste apsorbancije oko te valne duljine primjenjuju NAD(H) ili NADP(H).
English: Frequency not known: uveitis
Croatian: Učestalost nepoznata: uveitis
English: The potential of [Product name] to cause harm to an unborn baby is uncertain.
Croatian: Nije utvrđena mogućnost da [naziv lijeka] može naštetiti nerođenom djetetu.
English: Consult with the testing laboratory regarding the methodology used.
Croatian: Obratite se laboratoriju koji je proveo ispitivanje radi primijenjene metodologije.
English: If propylthiouracil is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended.
Croatian: Ako se propiltiouracil primjenjuje tijekom trudnoće, preporučuje se pomno praćenje majke, fetusa i novorođenčeta.
English: Frequency ‘not known': Drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: Učestalost „nepoznata”: reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
English: Loperamide - Brugada syndrome in the context of abuse with loperamide (EPITT no 19379)
Croatian: Loperamid - Brugada sindrom u kontekstu zlouporabe loperamida (EPITT br. 19379)
English: Propylthiouracil should be administered during pregnancy at the lowest effective dose without additional administration of thyroid hormones.
Croatian: Propiltiouracil je tijekom trudnoće potrebno primijeniti u najmanjoj učinkovitoj dozi bez dodatne primjene hormona štitnjače.
English: […] Overdose can unmask existing Brugada syndrome.
Croatian: Predoziranje […] Predoziranjem se može otkriti postojeći Brugada sindrom.
English: Individual benefit/risk assessment is necessary before treatment with propylthiouracil during pregnancy.
Croatian: Pojedinačna procjena omjera koristi i rizika nužna je prije liječenja propiltiouracilom tijekom trudnoće.
English: Sulfasalazine - Interference with dihydronicotinamideadenine dinucleotide / dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADP) reaction assays (EPITT no 19351)
Croatian: Sulfasalazin - interferencija s testom reakcije dihidronikotinamid-adenin dinukleotida / dihidronikotinamidadenin dinukleotid fosfata (NADH/NADP) (EPITT br. 19351)
English: Topiramate - Uveitis (EPITT no 19345)
Croatian: Topiramat - uveitis (EPITT br. 19345)
English: Fertility, pregnancy and lactation Women of childbearing potential
Croatian: 4.6. Plodnost, trudnoća i dojenje
English: Temozolomide - Drug reaction with eosinophilia and systemic symptoms (DRESS) (EPITT no 19332)
Croatian: Temozolomid - reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS) (EPITT br. 19332)
English: Rivaroxaban - Premature ending of the GALILEO study in patients who have received an artificial heart valve through a transcatheter aortic valve replacement (TAVR) (EPITT no
Croatian: Rivaroksaban - prerani završetak ispitivanja GALILEO u bolesnika koji su primili umjetni srčani zalistak transkateterskom zamjenom aortnog zaliska (TAVR) (EPITT br. 19294)
English: Secukinumab - Dermatitis exfoliative generalised (EPITT no 19354)
Croatian: Sekukinumab - generalizirani eksfolijativni dermatitis (EPITT br. 19354)
English: Undesirable effects Eye disorders
Croatian: Poremećaji oka
English: Overdose
Croatian: Nuspojave
English: Propylthiouracil - Risk of congenital anomalies (EPITT no
Croatian: Propiltiouracil - rizik od kongenitalnih anomalija (EPITT br. 19358)
English: Propylthiouracil is able to cross the human placenta.
Croatian: Propiltiouracil može proći kroz posteljicu u ljudi.
English: EU/1/08/453/002
Croatian: EU/1/08/453/002 Prepandrix 3,75 µg HA
English: 2.5 ml (suspension) 2.5 ml (emulsion)
Croatian: 2,5 ml (suspenzija) 2,5 ml (emulzija)
English: After mixing, 1 dose (0.5 ml) contains: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Croatian: Virus influence (fragmentiran, inaktiviran), sadrži antigene* koji odgovaraju soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
English: 50 vials (suspension) 2 x 25 vials (emulsion)
Croatian: 50 bočica (suspenzija) 2 x 25 bočica (emulzija)
English: 3.75 micrograms propagated in eggs ** haemagglutinin
Croatian: * umnoženi na jajima ** hemaglutinin
English: Prepandrix 3.75 µg HA1 Suspension and Emulsion for emulsion for injection
Croatian: Suspenzija i emulzija za emulziju za injekciju
English: Invented name
Croatian: ime
English: Packaging
Croatian: Primarno pakiranje
English: Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Croatian: U mišić suspenzija (H5N1):
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Croatian: Dodatak I Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene,
English: Hungary
Croatian: Madžarska
English: 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products for topical use Member
Croatian: Lijekovi koji sadrže 0,005 % w/w estradiola/0,4 % w/w prednizolona za topikalnu primjenu Država članica (u EGP)
English: 0.01 % w/w estradiol containing medicinal products for topical use Member
Croatian: Lijekovi koji sadrže 0,01 % w/w estradiola za topikalnu primjenu Država članica (u EGP)
English: Vaginal cream Vaginal use, topical use
Croatian: Krema za rodnicu U rodnicu, Topikalna primjena
English: Vaginal emulsion Cutaneous use, vaginal use
Croatian: Emulzija za rodnicu
English: Tafinlar is available as capsules (50 and 75 mg).
Croatian: Tafinlar je dostupan kao kapsula (50 i 75 mg).
English: It is used for the treatment of:
Croatian: Upotrebljava se i za liječenje:
English: Further information on Tafinlar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Tafinlar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Croatian: Glavno mjerilo djelotvornosti bio je postotak bolesnika koji su potpuno ili djelomično reagirali na liječenje.
English: Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur.
Croatian: Možda će biti potrebno prekinuti ili obustaviti liječenje te smanjiti dozu ako se razviju određene nuspojave.
English: Other information about Tafinlar
Croatian: Ostale informacije o lijeku Tafinlar
English: It is used in combination with trametinib.
Croatian: Primjenjuje se samo u kombinaciji s trametinibom.
English: What measures are being taken to ensure the safe and effective use of Tafinlar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tafinlar?
English: Tafinlar received a marketing authorisation valid throughout the EU on 26 August 2013.
Croatian: Lijek Tafinlar dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 26. kolovoza 2013.
English: Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.
Croatian: Približno 40 % bolesnika koji su primali kombinaciju lijekova umrlo je ili im se bolest vratila u prosjeku nakon 3,5 godina u usporedbi s 59 % bolesnika koji su primali placebo.
English: The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal).
Croatian: Doza lijeka Tafinlar koja se primjenjuje samostalno ili u kombinaciji s trametinibom je 150 mg dvaput dnevno na prazan želudac (barem 1 sat prije ili 2 sata nakon obroka).
English: By blocking the action of the abnormal BRAF, Tafinlar helps to slow down the growth and spread of the cancer.
Croatian: Blokiranjem djelovanja abnormalnog BRAF-a, Tafinlar pomaže usporiti rast i širenje raka.
English: What is Tafinlar and what is it used for?
Croatian: Što je Tafinlar i za što se primjenjuje?
English: An overview of Tafinlar and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Tafinlar i zašto je odobren u EU-u
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tafinlar 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 Tafinlar nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Liječenje lijekom Tafinlar mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Side effects reported with Tafinlar are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Tafinlar pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: As for all medicines, data on the use of Tafinlar are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Tafinlar kontinuirano se prate.
English: This was based on one main study involving 250 patients, which measured how long patients lived until their disease got worse.
Croatian: To se temeljilo na jednom glavnom ispitivanju koje je uključivalo 250 bolesnika kojim je mjereno vrijeme bez pogoršanja bolesti.
English: What are the risks associated with Tafinlar?
Croatian: Koji su rizici povezani s lijekom Tafinlar?
English: • advanced non-small cell lung cancer.
Croatian: • uznapredovalog raka pluća nemalih stanica.
English: Why is Tafinlar authorised in the EU?
Croatian: Zašto je lijek Tafinlar odobren u EU-u?
English: The most common side effects with Tafinlar (which may affect more than 1 in 10 people) are papilloma (warts), headache, nausea, vomiting, hyperkeratosis (thickening and toughening of the skin), hair loss, rash, joint pain, fever and tiredness.
Croatian: Najčešće nuspojave lijeka Tafinlar (zabilježene u više od 1 na 10 osoba) su papilomi (čirevi), glavobolja, mučnina, povraćanje, hiperkeratoza (zadebljana i tvrda koža), gubitak kose, osip, bol u zglobovima, vrućica i umor.
English: For more information about using Tafinlar, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Tafinlar pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Tafinlar was more effective than the cancer medicine dacarbazine at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Croatian: Tafinlar je učinkovitiji od lijeka protiv raka dakarbazina u kontroliranju melanoma koji se proširio na druge dijelove tijela ili se ne može kirurški ukloniti.
English: Tafinlar contains the active substance dabrafenib.
Croatian: Tafinlar sadrži djelatnu tvar dabrafenib.
English: Patients given the combination lived for 11 months without their disease worsening, compared with 8.8 months for those given Tafinlar alone.
Croatian: Bolesnici liječeni kombinacijom lijekova živjeli su 11 mjeseci bez pogoršanja bolesti, u usporedbi s 8,8 mjeseca u bolesnika koji su primali samo Tafinlar.
English: Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600'.
Croatian: Tafinlar je lijek protiv raka namijenjen samo odraslim bolesnicima čije su stanice raka pokazale specifičnu genetsku mutaciju (promjenu) koja se naziva BRAF V600.
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, the abnormal form of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Croatian: Kod melanoma i raka pluća nemalih stanica s mutacijom BRAF V600, abnormalni oblik BRAF-a djeluje na razvoj raka omogućavanjem nekontrolirane diobe stanica tumora.
English: How does Tafinlar work?
Croatian: Kako djeluje Tafinlar?
English: The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically.
Croatian: Agencija smatra i da koristi bolesnicima s uznapredovalim melanomom koji je kirurški uklonjen.
English: The use of Tafinlar and trametinib led to a response in over 60% of the patients, compared with 23% of patients using Tafinlar alone.
Croatian: Kombinirana primjena lijeka Tafinlar i trametiniba dovela je do reakcije u više od 60 % bolesnika, a monoterapija lijekom Tafinlar u 23 % bolesnika.
English: When Tafinlar is taken in combination with trametinib, the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Croatian: Kada se Tafinlar uzima u kombinaciji s trametinibom, najčešće nuspojave (zabilježene u više od 1 na 5 osoba) su vrućica, umor, mučnina, glavobolja, zimica, proljev, povraćanje, osip i bol u zglobovima.
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Tafinlar and trametinib given for 1 year was compared with placebo (a dummy treatment).
Croatian: U ispitivanju u kojem je sudjelovalo 870 bolesnika s melanomom faze III koji je kirurški odstranjen, uspoređena je primjena kombinacije Tafinlara i trametiniba tijekom 1 godine s primjenom placeba (prividnog liječenja).
English: Tafinlar can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back.
Croatian: Nakon operacije uznapredovalog melanoma liječenje se normalno nastavlja tijekom 12 mjeseci, osim ako se bolest ne vrati.
English: The Agency considered that Tafinlar when used alone or in combination with trametinib had shown clinically relevant benefit in patients with advanced non-small cell lung cancer or with melanoma that had spread or could not be removed surgically.
Croatian: Agencija smatra da je primjena lijeka Tafinlar samostalno ili u kombinaciji s trametinibom pokazala klinički relevantne prednosti u bolesnika s uznapredovalim rakom pluća nemalih stanica ili s melanomom koji se proširio ili se ne može kirurški ukloniti.
English: The European Medicines Agency decided that Tafinlar's benefits in cancers that carry the BRAF V600 mutation 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 Tafinlar za liječenje raka s mutacijom BRAF V600 nadmašuju s njim povezane rizike te da može biti odobren za primjenu u Europskoj uniji.
English: In one study 423 patients were given either the combination or Tafinlar alone.
Croatian: U jednom ispitivanju, 423 bolesnika primilo je ili kombinaciju lijekova ili samo Tafinlar.
English: Patients taking Tafinlar lived on average 6.9 months before the disease got worse, compared with 2.7 months in patients given dacarbazine.
Croatian: Bolesnici koji su primali lijek Tafinlar živjeli su u prosjeku 6,9 mjeseci bez pogoršanja bolesti, a oni koji su primali dakarbazin 2,7 mjeseci.
English: In a second study involving 704 patients, Tafinlar with trametinib was compared with another medicine for melanoma, vemurafenib.
Croatian: U drugom ispitivanju, kojim je bilo obuhvaćeno 704 bolesnika, kombinacija lijeka Tafinlar i trametiniba uspoređena je s drugim lijekom za liječenje melanoma, vemurafenibom.
English: What benefits of Tafinlar have been shown in studies?
Croatian: Koje su koristi od lijeka Tafinlar utvrđene u ispitivanjima?
English: In one main study, 171 patients with non-small cell lung cancer received either Tafinlar combined with trametinib or Tafinlar alone.
Croatian: U jednom glavnom ispitivanju 171 osoba oboljela od raka pluća nemalih stanica primala je ili Tafinlar u kombinaciji s trametinibom ili samo Tafinlar.
English: Tafinlar has been studied in patients whose cancer had the BRAF V600 mutation.
Croatian: Tafinlar je ispitivan u bolesnika koji boluju od raka s mutacijom BRAF V600.
English: Tafinlar's side effects were considered acceptable and manageable with appropriate measures.
Croatian: Nuspojave lijeka Tafinlar smatraju se prihvatljivima te da ih je moguće kontrolirati.
English: Patients given the combination lived 25.6 months on average, versus 18 months with vemurafenib.
Croatian: Bolesnici koji su primali kombinaciju lijekova živjeli su u prosjeku dulje, i to 25,6 mjeseci u odnosi na 18 mjeseci koliko su živjeli bolesnici kojima je davan vemurafenib.
English: For the full list of side effects and restrictions with Tafinlar, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Tafinlar potražite u uputi o lijeku.
English: How is Tafinlar used?
Croatian: Kako se Tafinlar primjenjuje?
English: • advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
Croatian: • uznapredovalog melanoma (faza III) nakon operacije.
English: The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division.
Croatian: Djelatna tvar lijeka Tafinlar, dabrafenib, inhibitor je bjelančevine BRAF koja potiče diobu stanica.
English: Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
Croatian: • melanoma (raka kože) koji se proširio ili se ne može kirurški odstraniti; Tafinlar se primjenjuje kao monoterapija ili u kombinaciji s trametinibom, drugim lijekom za liječenje raka;
English: Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Tafinlar with trametinib.
Croatian: U još dva ispitivanja ispitana je uporaba kombinacije lijekova Tafinlar i trametinib za melanom koji se proširio na druge dijelove tijeka ili se nije mogao kirurški ukloniti.
English: Take the remaining doses at the correct time.
Croatian: Preostale doze uzmite u ispravno vrijeme.
English: Date of first authorisation: 19 November 2015
Croatian: Datum prvog odobrenja: 19. studenog 2015
English: These differences are primarily explained by the lower body weight in females.
Croatian: Te se razlike primarno objašnjavaju nižom tjelesnom težinom u žena.
English: See section 4.
Croatian: Pogledajte odjeljak 4.
English: Take it as soon as you remember unless it is nearly time to take the next dose.
Croatian: Uzmite je čim se sjetite osim ako uskoro nije vrijeme za uzimanje sljedeće doze.
English: 30 months 90 days after first opening.
Croatian: 90 dana nakon prvog otvaranja.
English: Numient with food and drink
Croatian: Numient s hranom i pićem
English: You must swallow your capsules whole.
Croatian: Morate progutati cijele kapsule.
English: Each double-blind study period lasted 2 weeks.
Croatian: Svako razdoblje dvostruko slijepog ispitivanja trajalo je 2 tjedna.
English: What Numient is and what it is used for
Croatian: Što je Numient i za što se koristi
English: This is because the medicine may affect the results of some tests.
Croatian: To je zbog toga jer lijek može utjecati na rezultate nekih testova.
English: Other medicines and Numient
Croatian: Drugi lijekovi i Numient
English: Dosing this medicinal product more than 5 times per day is not recommended.
Croatian: Ne preporučuje se doziranje ovog lijeka više od 5 puta na dan.
English: If your diet contains too much protein (meat, eggs, milk, cheese), Numient may not work as well as it should.
Croatian: Ako Vaša prehrana sadrži previše proteina (meso, jaja, mlijeko, sir), Numient možda neće djelovati onako dobro kako bi trebao.
English: The daily dose must be determined by careful titration.
Croatian: Dnevna doza mora se odrediti pažljivom titracijom.
English: Because Parkinson's disease is progressive, periodic clinical evaluations are recommended.
Croatian: Budući da je Parkinsonova bolest progresivna, preporučuju se periodične kliničke procjene.
English: If you take more Numient than you should
Croatian: Ako uzmete više Numienta nego što ste trebali
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Croatian: Iznenadni nastup sna tijekom dnevnih aktivnosti, u nekim slučajevima bez svijesti o tome ili znakova upozorenja, prijavljen je vrlo rijetko.
English: Furthermore a reduction of dose or termination of therapy may be considered.
Croatian: Pored toga, može se razmotriti smanjenje doze ili prekid terapije.