FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of two ml: - F4ab (K88ab) fimbrial adhesin
Croatian: 2. IZJAVA DJELATNE(IH) I DRUGIH TVARI U dozi od dva ml: - F4ab (K88ab) fimbrijski adhesin
English: MARKETING AUTHORISATION NUMBER(S) EU/2/96/001/003-008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/96/001/003-008
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I NOSIOC(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
Croatian: PODACI KOJI SE POJAVLJUJU NA VANJSKOM PAKOVANJU 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
English: Potassium chlorideb
Croatian: Kalij kloridb
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Croatian: UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE
English: (E340i) All food-producing species
Croatian: (E340i)
English: TARGET SPECIES Pigs (sows and gilts)
Croatian: 3. CILJNE VRSTE Svinje(krmače i nazimice)
English: 4.2 Indications for use, specifying the target species For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains, which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
Croatian: Za pasivnu imunizacija prasadi te aktivnu imunizaciju krmača/nazimica, za smanjenje smrtnosti i kliničkih znakova kao što su: proljev zbog neonatalne enterotoksikoze tijekom prvih dana života, uzrokovane tim sojevima E.coli, koji izlučuju fimbrijski adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) ili F6(987P).
English: EU/2/96/001/008
Croatian: EU/2/96/001/008 100 ml PET
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 50 ml & 100 ml vial labels (EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/007 & EU/2/96/001/008 only)
Croatian: PODACI KOJI SE POJAVLJUJU NA UNUTARNJEM PAKOVANJU 50 ml i 100 ml bočice s etiketom (EU/2/96/001/004 , EU/2/96/001/005, EU/2/97/001/007 &EU/2/96/001/008 samo)
English: PACKAGE SIZE 100 ml (50 doses)
Croatian: 4. VELIČINA PAKOVANJA 100 ml (50 doza)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 20 ml & 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 & EU/2/96/001/007)
Croatian: 20 ml i 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 & EU/2/96/001/007)
English: CONTRA-INDICATIONS
Croatian: 4. INDIKACIJE
English: 13.. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
Croatian: 13. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: Pharmacologically active substance
Croatian: Farmakološka djelatna tvar
English: TARGET SPECIES Pigs (sows/gilts)
Croatian: 5. CILJNE VRSTE Svinje (krmače i nazimice)
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: 15. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: ROUTE(S) OF ADMINISTRATION IM injection
Croatian: 3. NAČIN PRIMJENE i.m injekcija
English: - Shake well before use.
Croatian: Pročitati uputu prije primjene.
English: Active substances: - F4ab (K88ab) fimbrial adhesin
Croatian: - F4ab (K88ab) fimbrijski adhesin
English: PACKAGE SIZE 20 ml (10 doses) 50 ml (25 doses)
Croatian: 4. VELIČINA PAKOVANJA 20 ml (10 doza)
English: B. PACKAGE LEAFLET
Croatian: 6. NUSPOJAVE
English: MARKETING AUTHORISATION HOLDER
Croatian: 14. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 20 ml vial labels (EU/2/96/001/003 & EU/2/96/001/006 only)
Croatian: ILI TRAKAMA 20 ml bočice s etiketom(EU/2/96/001/003i EU/2/96/001/006 samo)
English: Other provisions dl-α-tocopherol acetatea
Croatian: Vrsta životinje dl--tokoferol acetata
English: PACKAGE SIZE 50 ml (25 doses) 100 ml (50 doses)
Croatian: 50 ml (25 doza)
English: MANUFACTURER'S BATCH NUMBER Batch: .......
Croatian: 11. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Croatian: 16. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: (Dimethicone) All food-producing species a OJ No L122 of 12.05.99
Croatian: a SL L122 od 12.05.99
English: DATE OF RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Croatian: Doza Farmaceutski oblik Put primjene
English: 10 vials + 10 vials
Croatian: 3 bočice + 3 bočice
English: 1 vial + 1 ampoule
Croatian: 3 bočice + 3 ampule
English: The European Commission issued a decision on this opinion on 28/04/2017.
Croatian: Europska je komisija odluku o tom mišljenju objavila 28/04/2017.
English: The areas harmonised include:
Croatian: Područja koja je potrebno uskladiti obuhvaćaju:
English: Haldol Decanoate and associated names (such as Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat, and Serenase Depot) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Sweden and United Kingdom, and in Iceland and Norway.
Croatian: Haldol Decanoate i povezani nazivi (kao što su Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat i Serenase Depot) stavljaju se u promet u Austriji, Belgiji, na Cipru, Danskoj, Finskoj, Francuskoj, Grčkoj, Irskoj, Italiji, Luksemburgu, Nizozemskoj, Njemačkoj, Portugalu, Švedskoj, Ujedinjenoj Kraljevini te na Islandu i u Norveškoj.
English: The companies that market these medicines include Janssen-Cilag Ltd and associated companies.
Croatian: Poduzeća koja stavljaju u promet te lijekove uključuju Janssen-Cilag Ltd i povezana poduzeća.
English: Low doses are recommended for elderly patients unless they have already been receiving higher doses of haloperidol and have not had unacceptable side effects.
Croatian: Male doze preporučuju se za starije bolesnike, osim ako su već primali veće doze haloperidola bez pojave neprihvatljivih nuspojava.
English: Haldol Decanoate is authorised in the EU via national procedures.
Croatian: Lijek Haldol Decanoate odobren je u EU-u u okviru nacionalnih postupaka.
English: 4.4 Special warnings and precautions
Croatian: Posebna upozorenja i mjere opreza
English: What is Haldol Decanoate?
Croatian: Što je Haldol Decanoate?
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je rezultiralo razlikama među državama članicama u pogledu načina primjene lijeka, što je vidljivo u razlikama u sažetcima opisa svojstava lijeka, označivanju i uputama o lijeku u zemljama u kojima se lijek stavlja u promet.
English: In particular, Haldol Decanoate must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness).
Croatian: Haldol Decanoate se posebice ne smije upotrebljavati u bolesnika s poremećajima rada srca, kao što su određeni problemi sa srčanim ritmom, zatajenje srca i nedavni srčani udar, te depresija središnjeg živčanog sustava (smanjena aktivnost mozga koja usporava disanje i srčani ritam te smanjuje budnost).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol Decanoate in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje lijeka Haldol Decanoate u Europskoj uniji (EU).
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol Decanoate and other medicines (section 4.5), as well as information on pregnancy, lactation and fertility (section
Croatian: CHMP je uskladio ostale odjeljke sažetka opisa svojstava lijeka, uključujući interakciju između lijeka Haldol Decanoate i ostalih lijekova (odjeljak 4.5.) te informacije o trudnoći, dojenju i plodnosti (odjeljak 4.6.).
English: Why was Haldol Decanoate reviewed?
Croatian: Zašto je Haldol Decanoate ponovno ocjenjivan?
English: It is also available in the EU as generic haloperidol decanoate.
Croatian: Dostupan je u EU-u i kao generički haloperidol dekanoat.
English: Haldol Decanoate is an antipsychotic medicine used for schizophrenia and schizoaffective disorder (schizophrenia with mood disorders), which are mental disorders that affect how the person thinks, feels or behaves.
Croatian: Haldol Decanoate je antipsihotik koji se upotrebljava za liječenje shizofrenije i shizoafektivnog poremećaja (shizofrenija s poremećajima raspoloženja), mentalnih poremećaja koji utječu na način razmišljanja, osjećanja i ponašanja.
English: Haldol Decanoate is given by injection into the muscle usually every 4 weeks, to patients who have been taking haloperidol by mouth.
Croatian: Haldol Decanoate primjenjuje se ubrizgavanjem injekcijom u mišić obično svaka četiri tjedna u bolesnika koji su uzimali haloperidol kroz usta.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Odbora, CHMP je smatrao da se sažetci opisa svojstava lijekova, označivanje i upute za lijekove moraju uskladiti na razini EU-a.
English: On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol Decanoate and associated names in the EU.
Croatian: Europska je komisija 18. lipnja 2014. uputila predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Haldol Decanoate i povezanih naziva u EU-u.
English: EMA/122472/2017 Rev 1 EMEA/H/A-30/1405
Croatian: 1 EMEA/H/A-30/1405
English: The CHMP agreed that Haldol Decanoate injection can be used for the continuing treatment of schizophrenia and schizoaffective disorder in adults who have been on a stable dose of haloperidol by mouth.
Croatian: CHMP se usuglasio oko toga da se Haldol Decanoate u obliku za otopine za ubrizgavanje injekcijom može upotrebljavati za trajno liječenje shizofrenije i shizoafektivnog poremećaja u odraslih bolesnika koji su primali stabilnu dozu haloperidola kroz usta.
English: The CHMP agreed to harmonisation of Haldol Decanoate's contra-indications.
Croatian: CHMP se usuglasio oko usklađivanja kontraindikacija lijeka Haldol Decanoate.
English: The CHMP harmonised the SmPC to include information on when Haldol Decanoate's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain.
Croatian: CHMP je uskladio sažetak opisa svojstava lijeka radi uključivanja informacija o mogućem vremenu javljanja nuspojava lijeka Haldol Decanoate povezanih s kretanjem, pojedinostima o smrtnosti u starijih bolesnika te učincima na srce i mozak.
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol Decanoate.
Croatian: Europska agencija za lijekove dovršila je ocjenjivanje lijeka Haldol Decanoate 24. veljače 2017.
English: The SmPC recommends caution in patients who have a high level of the hormone prolactin and in those who have tumours that are worsened by prolactin.
Croatian: U sažetku opisa svojstava lijeka preporučuje se oprez u bolesnika s visokom razinom hormona prolaktina i u bolesnika koji imaju tumore koje prolaktin pogoršava.
English: It contains the active ingredient haloperidol decanoate.
Croatian: Sadržava djelatnu tvar haloperidol dekanoat.
English: The CHMP has harmonised the guidance on calculating the dose of Haldol Decanoate based on the patient's dose of haloperidol by mouth.
Croatian: CHMP je uskladio smjernice o izračunu doze lijeka Haldol Decanoate na temelju doze haloperidola koju je bolesnik uzimao kroz usta.
English: Haldol Decanoate was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska skupina za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) utvrdila je da je u pogledu lijeka Haldol Decanoate potrebno provesti usklađivanje.
English: After first opening: 40 days
Croatian: Nakon prvog otvaranja: 40 dana
English: The four components of this comprehensive program are:
Croatian: Četiri komponente ovog opsežnog programa su:
English: Your doctor may gradually increase your dose.
Croatian: Vaš liječnik može postupno povećati vašu dozu.
English: What Xyrem is and what it is used for
Croatian: Što je Xyrem i za što se koristi
English: This needs only to be done the first time that the bottle is opened.
Croatian: Ovaj postupak treba napraviti samo prvi put kad otvarate bocu.
English: You should take the labelled medicine bottle with you, even if it is empty.
Croatian: Uvijek uzmite bocu lijeka sa sobom, čak i ako je prazna.
English: Not known: dry mouth
Croatian: Nepoznato: suha usta
English: • topiramate (used for treatment of epilepsy)
Croatian: • topiramat (koristi se za liječenje epilepsije)
English: To date no other relevant epidemiological data are available.
Croatian: Za sada ne postoje odgovarajući epidemiološki podaci.
English: If you take more Xyrem than you should
Croatian: Ako uzmete više Xyrema nego što ste trebali
English: Patients with major depression.
Croatian: Bolesnici s teškom depresijom.
English: Allée de la Recherche 60 B-1070 Brussels Belgium
Croatian: Allée de la Recherche 60 B-1070 Bruxelles Belgija
English: Other mechanisms, which have yet to be elucidated, may also be involved.
Croatian: Moguće da postoje i drugi mehanizmi koje će trebati još razjasniti.
English: The following instructions explain how to prepare Xyrem.
Croatian: Sljedeće upute objašnjavaju kako pripremiti Xyrem.
English: The medicinal product should be used within 40 days after the first opening.
Croatian: Lijek treba iskoristiti unutar 40 dana nakon prvog otvaranja.
English: Injury, poisoning and procedural complications Common: fall
Croatian: Ozljede, trovanja i proceduralne komplikacije Često: pad
English: Take Xyrem orally two times each night.
Croatian: Uzmite Xyrem kroz usta dva puta svake večeri.
English: Responders* N (%)
Croatian: Bolesnici s odgovorom* N (%)
English: Other medicines and Xyrem
Croatian: Drugi lijekovi i Xyrem
English: • medicines that increase central nervous system activity and antidepressants
Croatian: • lijekove koji pojačavaju aktivnost središnjeg živčanog sustava i antidepresive
English: Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava: vrlo često (≥1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: It is not always possible to reliably estimate the frequency of their incidence in the population to be treated.
Croatian: Nije uvijek moguće pouzdano procijeniti učestalost njihove incidencije u liječenoj populaciji.
English: Secondary Efficacy Duration Active treatment and Dose (g/d)
Croatian: Trajanje Aktivno liječenje i doza (g/d)
English: Abuse potential and dependence
Croatian: Rizik od zlouporabe i ovisnosti
English: Once you open a bottle of Xyrem, any contents that you have not used with 40 days of opening should be disposed of.
Croatian: Jednom kada otvorite bocu Xyrema, sav sadržaj koji ne iskoristite unutar 40 dana nakon otvaranja trebate baciti.
English: On average, less than 5% of unchanged medicinal product appears in human urine within 6 to 8 hours after dosing.
Croatian: U prosjeku manje od 5% nepromijenjenog lijeka pojavljuje se u urinu 6 do 8 sati nakon doziranja.
English: These are usually mild to moderate.
Croatian: One su obično blage do umjerene.
English: Placebo 3.0 g/day 6.0 g/day 9.0 g/day
Croatian: Placebo 3,0 g/dan 6,0 g/dan 9,0 g/dan
English: * The CGI-c data were analysed by defining responders as those patients who were very much improved or much improved.
Croatian: * CGI-c podaci analizirani su na način da su bolesnici s odgovorom definirani kao oni kojima se stanje značajno ili jako značajno popravilo.
English: If you forget to take the first dose, take it as soon as you remember and then continue as before.
Croatian: Ako ste zaboravili uzeti prvu dozu uzmite ju čim se sjetite, a nakon toga nastavite uzimati lijek kao prije.
English: When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup.
Croatian: Kad se probudite 2,5 do 4 sata kasnije, odstranite zatvarač s druge dozirne čaše.
English: Food decreases the amount of Xyrem that is absorbed by your body.
Croatian: Hrana smanjuje količinu Xyrema koja se apsorbira u tijelu.
English: Children and adolescents Do not give this medicine to children and adolescents.
Croatian: Nemojte dati ovaj lijek djeci i adolescentima.
English: Therefore, it is best to take Xyrem at set times two-three hours after a meal.
Croatian: Stoga je najbolje uzeti Xyrem uvijek u isto vrijeme dva-tri sata nakon obroka.
English: No active metabolites have been identified.
Croatian: Aktivni metaboliti nisu poznati.
English: These levels are considerably higher than levels achieved with therapeutic doses.
Croatian: Ove razine su značajno veće od razina koje se postižu primjenom terapijskih doza.
English: You may need to set an alarm clock to make sure you wake up to take the second dose.
Croatian: Možda ćete morati namjestiti alarm za buđenje kako biste bili sigurni da ćete se probuditi na vrijeme za uzimanje druge doze.
English: It is unclear if some or all of these episodes correspond to true somnambulism (a parasomnia occurring during non-REM sleep) or to any other specific medical disorder.
Croatian: Nije poznato da li neke ili sve te epizode odgovaraju pravom somnambulizmu (parasomnija koja se javlja tijekom non-REM faze spavanja) ili nekom drugom specifičnom medicinskom poremećaju.
English: Just before going to sleep, place your second dose near your bed.
Croatian: Neposredno prije odlaska na spavanje postavite drugu dozu uz svoj krevet.
English: If you have liver problems, the starting dose should be halved.
Croatian: Ako imate problema s jetrom, početnu dozu treba prepoloviti.
English: Remove the syringe from the centre opening of the bottle.
Croatian: Odstranite štrcaljku iz središnjeg otvora boce.
English: Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown.
Croatian: Xyrem djeluje tako da poboljšava noćno spavanje, iako točan mehanizam djelovanja nije poznat.
English: What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem
Croatian: Što je Xyrem i za što se koristi Što morate znati prije nego počnete uzimati Xyrem Kako uzimati Xyrem
English: The adaptor can then be left in the bottle for all subsequent uses
Croatian: Nastavak može ostati u boci za naredna korištenja.
English: Single doses greater than 4.5 g have not been studied.
Croatian: Pojedinačne doze veće od 4,5 g nisu ispitivane.
English: It is eliminated mainly by metabolism with a half-life of 0.5 to 1 hour.
Croatian: Uglavnom se eliminira tako da se metabolizira uz poluvijek od 0,5 do 1 sat.
English: If you miss the second dose, skip that dose and do not take Xyrem again until the next night.
Croatian: Ako zaboravite uzeti drugu dozu, preskočite tu dozu i ne uzimajte Xyrem ponovno do iduće noći.
English: Repeat this step for the second dosing cup.
Croatian: Ponovite isti postupak za drugu dozirnu čašu.
English: Carton and bottle
Croatian: Kutija i boca
English: Most data derives from the illicit use of GHB.
Croatian: Većina podataka proizlazi iz iskustva s nedozvoljenom primjenom GHB-a.
English: Therefore, episodes of sleepwalking should be fully evaluated and appropriate interventions considered.
Croatian: Stoga epizode hodanja u snu treba u potpunosti evaluirati i razmisliti o provođenju odgovarajućih intervencija.
English: Then add about 60 ml of water to each dosing cup (60 mL is about 4 tablespoons).
Croatian: Zatim dodajte oko 60 ml vode u svaku dozirnu čašu (60 mL su otprilike 4 jušne žlice).
English: The risk of taking Xyrem during pregnancy is unknown, and, therefore, the use of Xyrem in pregnant women or women trying to become pregnant is not recommended.
Croatian: Nije poznato kakav rizik nosi uzimanje Xyrema tijekom trudnoće i zato se primjena Xyrema u trudnica ili žena koje planiraju trudnoću ne preporučuje.
English: Cheyne-Stokes respiration and apnoea have been observed.
Croatian: Uočeno je i Cheyne-Stokesovo disanje te apneja.
English: You should continue to take Xyrem for as long as instructed by your doctor.
Croatian: Nastavite uzimati Xyrem onoliko dugo koliko Vam je odredio Vaš liječnik.
English: What you need to know before you take Xyrem
Croatian: Što morate znati prije nego počnete uzimati Xyrem
English: Placebo (56) Sodium Oxybate (55) Modafinil (63) Sodium Oxybate + Modafinil (57)
Croatian: Placebo (56) Natrijev oksibat (55) Modafinil (63) Natrijev oksibat + Modafinil (57)
English: You need to monitor the amount of salt you take as Xyrem contains sodium (which is found in table salt) which may affect you if you have had high blood pressure, heart or kidney problems in the past.
Croatian: Trebate pratiti količinu soli koju uzimate budući da Xyrem sadrži natrij (koji se nalazi u kuhinjskoj soli) koji može utjecati na Vas ako ste u prošlosti imali povišen krvni tlak, probleme sa srcem ili bubrezima.
English: The safety and efficacy of sodium oxybate in children and adolescents aged 0-18 years has not been established.
Croatian: Sigurnost i djelotvornost primjene natrijeva oksibata u djece i adolescenata u dobi 0-18 godina nije utvrđena.
English: If you stop taking Xyrem for more than 14 consecutive days you should consult your doctor as you should restart taking Xyrem at a reduced dose.
Croatian: Ako prestanete uzimati Xyrem više od 14 uzastopnih dana, morali biste se posavjetovati s Vašim liječnikom jer biste morali ponovno početi uzimati Xyrem sa sniženom dozom.
English: You may need to set an alarm so you wake up to take your second dose no earlier than 2.5 hours and no later than 4 hours after your first dose.
Croatian: Možda ćete morati namjestiti alarm za buđenje kako biste svoju drugu dozu uzeli ne prije 2,5 sata niti kasnije od 4 sata nakon prve doze.
English: Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level.
Croatian: Pojedinačne doze od 4,5 g ne smiju se primijeniti, osim ako je u bolesnika prethodno provedena titracija do te doze.
English: Whilst there is no clear evidence of emergence of dependence in patients taking sodium oxybate at therapeutic doses, this possibility cannot be excluded.
Croatian: Iako još nema jasnog dokaza o pojavi ovisnosti u bolesnika koji uzimaju natrijev oksibat u terapijskim dozama, ta se mogućnost ne može isključiti.
English: There have been very few women who have taken Xyrem sometime during their pregnancy and a few of them had spontaneous abortions.
Croatian: Mali broj trudnica je u nekom razdoblju trudnoće uzimalo Xyrem i neke od njih su imale spontani pobačaj.
English: Xyrem 6 - 9 Modafinil 200-600 mg
Croatian: 8 tjedana Xyrem 6 - 9 Modafinil 200600 mg