FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Croatian: Bolesnici (i njegovatelji bolesnika) trebaju biti upozoreni o potrebi nadziranja bilo kojeg kliničkog pogoršanja, suicidalnog ponašanja ili misli i neobičnih promjena u ponašanju i odmah potražiti savjet liječnika ako primijete ove simptome.
English: Patients who did not meet the early response criterion were not found to have increased tolerability or safety issues relative to patients who did have a favourable early response.
Croatian: U bolesnika koji nisu zadovoljili kriterij ranog odgovora, utvrđeno je da nemaju povećane probleme s podnošljivosti ili sa sigurnosti u odnosu na bolesnike koji su imali povoljan rani odgovor.
English: The tablets should preferably be taken with food (see section 5.2).
Croatian: Tablete treba po mogućnosti uzeti sa hranom (vidjeti dio 5.2).
English: Obesity in adults over 18 years of age is defined as a body mass index of greater than or equal to 30 and overweight in adults over 18 years of age is defined as a body mass index greater than or equal to 27 and less than 30.
Croatian: Pretilost u odraslih iznad 18 godina je definirana kao indeks tjelesne mase veći od ili jednak 30, a prekomjerna težina u odraslih iznad 18 godina je definirana kao indeks tjelesne mase veći ili jednak 27 i manji od 30.
English: The treatment should be discontinued if there are concerns with the safety or tolerability of ongoing treatment, including concerns about increased blood pressure (see Section 4.8).
Croatian: Liječenje treba prekinuti ako postoje zabrinutosti oko sigurnosti i podnošljivosti liječenja u tijeku, uključujući i zabrinutosti oko povećanog krvnog tlaka (vidjeti dio 4.8).
English: Overall adherence was similar between trials, and similar between treatment groups.
Croatian: Sveukupno pridržavanje je bilo slično između ispitivanja i slično između liječenih skupina.
English: The clinical relevance of these equivocal findings is unknown.
Croatian: Klinički značaj ovih dvosmislenih nalaza je nepoznat.
English: Polska Valeant Pharma Poland sp. z o.o.
Croatian: Valeant Pharma Poland sp. z o.o.
English: Use caution when taking Mysimba, if you are 65 years or older.
Croatian: Budite oprezni prilikom uzimanja lijeka Mysimba, ako imate 65 godina ili više.
English: Non-clinical data on individual components reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Croatian: Neklinički podaci o pojedinim sastavnicama ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosti, farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
English: Mysimba has been shown to cause fits (seizures) in up to 1 in 1,000 patients (see also section 4).
Croatian: Pokazalo se da lijek Mysimba uzrokuje napadaje u do 1 na 1000 bolesnika (vidjeti također dio 4).
English: Mysimba may be discontinued by your doctor after 16 weeks if you have not lost at least 5 percent of your initial body weight.
Croatian: Lijek Mysimba se može obustaviti od strane liječnika nakon 16 tjedana, ako niste izgubili barem 5 posto svoje početne tjelesne težine.
English: If you take more Mysimba than you should
Croatian: Ako uzmete više lijeka Mysimba nego što ste trebali
English: The maximum recommended daily dose of Mysimba is two tablets taken twice a day.
Croatian: Maksimalna preporučena dnevna doza lijeka Mysimba su dvije tablete uzete dva puta na dan.
English: You may need to take Mysimba for at least 16 weeks to have its full effect.
Croatian: Trebali bi uzimati lijek Mysimba najmanje 16 tjedana kako biste osjetili njen potpuni učinak.
English: If you have problems with your liver or kidney, or if you are older than 65, and depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you or recommend that you take a different dose, and monitor you more closely for potential side effects.
Croatian: Ako imate problema s jetrom ili bubrezima, ili ako ste stariji od 65 godina, a ovisno o težini Vaših problema, Vaš liječnik mora pažljivo razmotriti je li ovaj lijek prikladan za Vas ili preporučiti uzimanje drugačije doze i pratiti Vas pobliže na moguće nuspojave.
English: The combination has not been tested in reproductive toxicity studies.
Croatian: Kombinacija nije ispitana u ispitivanjima reproduktivne toksičnosti.
English: Symptoms of a fit include convulsions and usually loss of consciousness.
Croatian: Simptomi napadaja su konvulzije i obično gubitak svijesti.
English: There is an increased incidence of gastrointestinal disorders with higher age categories.
Croatian: Postoji i povećana incidencija gastrointestinalnih poremećaja u kategorijama starije dobi.
English: After you stop treatment with Mysimba you may be more sensitive to low doses of opiates (see “Do not take Mysimba”).
Croatian: Nakon što prestanete liječenje lijekom Mysimba možete biti osjetljiviji na niske doze opijata (vidjeti „Nemojte uzimati lijek Mysimba”).
English: • Patients with a known central nervous system tumour
Croatian: • Bolesnici s poznatim tumorom središnjeg živčanog sustava
English: Tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects:
Croatian: Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova, jer će Vas liječnik pažljivo pratiti na nuspojave:
English: When feasible, the option of therapeutic drug monitoring should be considered for medicinal products with a narrow therapeutic index, such as tricyclic antidepressants.
Croatian: Kada je to moguće, treba razmotriti mogućnost terapijskog praćenja lijeka za lijekove s uskim terapijskim indeksom, kao što su triciklički antidepresivi.
English: • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu(e) tvar(i) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: If your blood pressure or heart rate increases significantly, you may need to stop taking Mysimba.
Croatian: Ako se Vaš krvni tlak ili puls znatno povećaju, možda ćete morati prestati uzimati lijek Mysimba.
English: Bupropion is indicated for the treatment of depression in some countries.
Croatian: U nekim zemljama bupropion je indiciran za liječenje depresije.
English: This suggests that the hepatic findings in laboratory animals have only limited importance in the evaluation and risk assessment of bupropion.
Croatian: To ukazuje na to da jetreni nalazi u laboratorijskih životinja imaju samo ograničenu važnost u procjeni i ocjeni rizika bupropiona.
English: You must stop taking these medicines for at least 14 days before starting Mysimba (see “Do not take Mysimba”).
Croatian: Morate prestati uzimati te lijekove najmanje 14 dana prije početka uzimanja lijeka Mysimba (vidjeti „Nemojte uzimati lijek Mysimba”).
English: CYP2D6 substrates
Croatian: CYP2D6 supstrati
English: Mysimba is not recommended if you are over 75 years.
Croatian: Lijek Mysimba se ne preporučuje ako ste stariji od 75 godina.
English: Any effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: Bilo koji učinci u nekliničkim ispitivanjima uočeni su samo pri izloženostima lijeka za koje se smatra da su dovoljno veći od maksimalne izloženosti u ljudi, ukazujući na malu važnost za kliničku uporabu.
English: Do not stop taking Mysimba without talking to your doctor first.
Croatian: Nemojte prestati uzimati lijek Mysimba bez da se najprije savjetujete s liječnikom.
English: An adequate airway, oxygenation, and ventilation should be ensured.
Croatian: Treba osigurati odgovarajuću prohodnost, oksigenaciju i ventilaciju dišnih putova.
English: Naltrexone / bupropion may be used with caution after chronic opioid use has been stopped for 7 to 10 days in order to prevent precipitation of withdrawal.
Croatian: Naltrekson / bupropion se može koristiti s oprezom nakon što je kronična uporaba opioida prekinuta na 7 do 10 dana kako bi se spriječila precipitacija ustezanja.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Mysimba in one or more subsets of the paediatric population in obesity (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Mysimba u jednoj ili više podskupina pedijatrijske populacije s pretilosti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Ticlopidine or clopidogrel, mainly used in the treatment of heart disease or stroke;
Croatian: • tiklopidin i klopidogrel, koji se uglavnom koriste u liječenju srčanih bolesti ili moždanog udara;
English: - a reminder of the contraindications, warnings and precautions as well as patient characteristics that place patients at higher risk of adverse reactions to Mysimba, to help ensure appropriate patient selection.
Croatian: - podsjetnik na kontraindikacije, upozorenja i mjere opreza kao i karakteristike bolesnika koje stavljaju bolesnika u viši rizik od nuspojava na lijek Mysimba, kako bi se pomoglo osigurati odgovarajući odabir bolesnika.
English: Metabolites of bupropion (and to a lesser extent unmetabolised bupropion) accumulate and reach steady state concentrations in approximately one week.
Croatian: Metaboliti bupropiona (i u manjoj mjeri nemetaboliziran bupropion) se akumuliraju i dostižu koncentraciju stanja dinamičke ravnoteže za oko tjedan dana.
English: Bupropion and its metabolites inhibit CYP2D6.
Croatian: Bupropion i njegovi metaboliti inhibiraju CYP2D6.
English: The metabolites have longer elimination half-lives than bupropion and accumulate to a greater extent.
Croatian: Metaboliti imaju duži poluvijek eliminacije od bupropiona i akumuliraju se u većoj mjeri.
English: Liver changes are seen in animal studies with bupropion but these reflect the action of a hepatic enzyme inducer.
Croatian: Promjene jetre su opažene u životinjskim ispitivanjima s bupropionom, ali one odražavaju djelovanje induktora jetrenih enzima.
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Mysimba.
Croatian: Prijavljeni su slučajevi depresije, suicidalnih misli, i pokušaja samoubojstva tijekom liječenja lijekom Mysimba.
English: Not known - frequency cannot be estimated from the available data in people taking Mysimba.
Croatian: Nepoznato - učestalost se ne može procijeniti iz dostupnih podataka kod osoba koje uzimaju lijek Mysimba.
English: As NB is a fixed combination of two active ingredients, in addition to the terms listed in Table 1, additional adverse reactions seen with one of the active substances may potentially occur.
Croatian: Budući da je NB fiksna kombinacija dvije djelatne tvari, osim nuspojava navedenih u tablici 1, mogu se pojaviti dodatne nuspojave uočene s jednim od sastojaka.
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: (≥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: Ask your doctor for advice before you drive and operate machines since Mysimba might make you feel dizzy and sleepy which may weaken your ability to concentrate and react.
Croatian: Obratite se svom liječniku za savjet prije upravljanja vozilima ili rada sa strojevima jer lijek Mysimba može uzrokovati omaglicu i pospanost što može oslabjeti Vašu sposobnost koncentracije i reagiranja.
English: These results suggest that most of the total weight loss was attributable to a reduction in adipose tissue, including visceral adipose.
Croatian: Ovi rezultati upućuju na to da se većina ukupnog gubitka težine može pripisati smanjenju masnog tkiva uključujući visceralno masno tkivo.
English: • you have high blood pressure before taking Mysimba, because it can become worse.
Croatian: • imate povišeni krvni tlak prije uzimanja lijeka Mysimba, jer se može pogoršati.
English: Rare - may affect up to 1 in 1,000 people taking Mysimba with risk of having a fit.
Croatian: Rijetko - mogu se pojaviti u do 1 na 1000 osoba koje uzimaju lijek Mysimba s rizikom od napadaja.
English: Naltrexone and its metabolites are excreted primarily by the kidney (37 to 60% of the dose).
Croatian: Naltrekson i njegovi metaboliti izlučuju se prvenstveno putem bubrega (37 do 60 % doze).
English: Blood pressure and pulse should be measured prior to initiation of therapy with naltrexone / bupropion and should be assessed at regular intervals consistent with usual clinical practice.
Croatian: Krvni tlak i puls treba mjeriti prije započinjanja terapije s naltrekson / bupropionom i mora ih se procjenjivati u redovnim intervalima u skladu s uobičajenom kliničkom praksom.
English: Plasma protein binding is not extensive for naltrexone (21%) or bupropion (84%) indicating low potential for drug interactions by displacement.
Croatian: Vezanje na proteine plazme nije opsežno za naltrekson (21 %) ili bupropion (84 %) što ukazuje na niski potencijal za interakcije lijeka zamjenom.
English: Plasma protein binding of hydroxybupropion is similar to that of bupropion (84%) whereas the other two metabolites have approximately half the binding.
Croatian: Vezanje hidroksibupropiona na plazma proteine je slično vezanju bupropiona (84 %) dok druga dva metabolita imaju otprilike polovicu vezanja.
English: Prior to launch of Mysimba in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the prescriber guide with the National Competent Authority.
Croatian: Prije puštanja lijeka Mysimba u promet u svakoj državi članici nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti sadržaj i format vodiča za propisivanje s nacionalnim nadležnim tijelom.
English: Rhabdomyolysis is an abnormal breakdown of muscle tissue which can lead to kidney problems.
Croatian: Rabdomioliza je abnormalni raspad mišićnog tkiva koji može dovesti do problema s bubrezima.
English: Blue, biconvex, round tablet of 12.0-12.2 mm diameter debossed with “NB-890” on one side.
Croatian: Plava, bikonveksna, okrugla tableta promjera 12,0-12,2 mm s utisnutim “NB-890” na jednoj strani.
English: Naltrexone / bupropion was also evaluated in combination with intensive behavioural modification counseling in the NB-302 study.
Croatian: Naltrekson / bupropion također je procijenjen u kombinaciji s intenzivnim savjetovanjem promjene ponašanja u ispitivanju NB-302.
English: If you experience fainting, muscle weakness or fits during treatment, do not drive or use machines.
Croatian: Ako doživite nesvjesticu, mišićnu slabost ili napadaje tijekom liječenja, nemojte upravljati vozilima ili raditi sa strojevima.
English: Naltrexone / bupropion contains bupropion.
Croatian: Naltrekson / bupropion sadrži bupropion.
English: 6.4 Special precautions for storage Do not store above 30°C.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 30°C
English: Genotoxicity data indicate that bupropion is a weak bacterial mutagen, but not a mammalian mutagen, and therefore is of no concern as a human genotoxic agent.
Croatian: Podaci genotoksičnosti ukazuju na to da je bupropion slab bakterijski mutagen, ali nije mutagen sisavaca, te stoga nema zabrinutosti da je gentotoksičan za ljude.
English: • if you are currently dependent on or addicted to cocaine or other stimulating products;
Croatian: • ako ste trenutno ovisni ili ste ovisnik o kokainu ili drugim stimulativnim lijekovima;
English: Studies with naltrexone in animals have shown reproductive toxicity (see section 5.3); animal studies with bupropion show no clear evidence of reproductive harm.
Croatian: Ispitivanja na životinjama s naltreksonom pokazala su reproduktivnu toksičnost (vidjeti dio 5.3); ispitivanja na životinjama s bupropionom ne daju jasan dokaz štetnog učinka na reprodukciju.
English: However, there is some evidence on hepatotoxicity with increasing dose, since reversible increases of liver enzymes have been found in humans with therapeutic and higher doses (see section 4.4 and 4.8).
Croatian: Međutim, postoje neki dokazi o hepatotoksičnosti s povećanjem doze, budući da su nađeni reverzibilni porasti jetrenih enzima kod ljudi s terapijskim i višim dozama (vidjeti dio 4.4 i 4.8).
English: Naltrexone / bupropion should not be used during pregnancy or in women currently attempting to become pregnant.
Croatian: Naltrekson / bupropion se ne smije koristiti tijekom trudnoće, ili u žena koje trenutno pokušavaju ostati trudne.
English: When α-MSH is released, POMC neurons simultaneously release β-endorphin, an endogenous agonist of the mu-opioid receptors.
Croatian: Kad se α-MSH otpušta, POMC neuroni istodobno otpuštaju β-endorfin, koji je endogeni agonist mu-opioidnih receptora.
English: Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna tableta s produljenim oslobađanjem sadrži 73,2 mg laktoze (vidjeti dio 4.4).
English: Symptoms include severe muscle cramps, muscle pain or muscle weakness.
Croatian: Simptomi uključuju teške grčeve u mišićima, bol u mišićima ili mišićnu slabost.
English: Older People
Croatian: Starije osobe
English: These components affect two principal areas of the brain, specifically the arcuate nucleus of the hypothalamus and the mesolimbic dopaminergic reward system.
Croatian: Ove sastavnice utječu na dva glavna područja u mozgu, a posebno na arkuatnu jezgru hipotalamusa i mezolimbički dopaminergički sustav nagrade.
English: Though less potent than naltrexone, 6-beta-naltrexol is eliminated more slowly and thus circulates at much higher concentrations than naltrexone.
Croatian: Iako slabije djelotvoran od naltreksona, 6-beta-naltreksol se eliminira sporije i stoga cirkulira pri puno višim koncentracijama od naltreksona.
English: Naltrexone blocks the effects of opiates; if you take higher doses of opiates to overcome these effects of naltrexone, you may suffer from an acute opiate intoxication which may be life threatening.
Croatian: Naltrekson blokira djelovanje opijata; ako uzmete veće doze opijata za prevladavanje tih učinaka naltreksona, možete doživjeti akutnu intoksikaciju opijatima koja može biti opasna za život.
English: • Patients undergoing acute alcohol or benzodiazepine withdrawal
Croatian: • Bolesnici koji se podvrgavaju akutnom ustezanju od alkohola ili benzodiazepina
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza “EXP”.
English: Excessive use of alcohol while being treated with Mysimba might increase the risk for fits (seizures), mental disorder events or might reduce alcohol tolerance.
Croatian: Pretjerana uporaba alkohola, dok se liječite s lijekom Mysimba može povećati rizik od napadaja, događaja mentalnih poremećaja ili možda smanjiti toleranciju alkohola.
English: Other medicines and Mysimba
Croatian: Drugi lijekovi i lijek Mysimba
English: Although clinical data do not identify a pharmacokinetic interaction between bupropion and alcohol, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients drinking alcohol during bupropion treatment.
Croatian: Iako klinički podaci ne identificiraju farmakokinetičku interakciju između bupropiona i alkohola, bilo je rijetkih prijava štetnih neuropsihijatrijskih događaja ili smanjene tolerancije alkohola u bolesnika koji su pili alkohol tijekom liječenja bupropionom.
English: Opioid analgesics
Croatian: Opioidni analgetici
English: In clinical practice with other bupropion containing products, hypertension, in some cases severe and requiring acute treatment, has been reported.
Croatian: U kliničkoj praksi s drugim lijekovima koji sadržavaju bupropion, prijavljena je hipertenzija, u nekim slučajevima i ozbiljna koja je zahtijevala akutno liječenje.
English: No events of nausea, constipation, or vomiting were considered serious.
Croatian: Niti jedan događaj mučnine, zatvora ili povraćanja nije smatran ozbiljnim.
English: The major metabolite of naltrexone is 6-beta-naltrexol.
Croatian: Glavni metabolit naltreksona je 6-beta-naltreksol.
English: The tablets should not be cut, chewed, or crushed.
Croatian: Tablete se ne smiju rezati, žvakati ili drobiti.
English: There were no consistent changes in naltrexone or bupropion metabolites related to varying degrees of hepatic impairment.
Croatian: Nije bilo konzistentnih promjena metabolita naltreksona ili bupropiona povezanih s različitim stupnjevima oštećenja jetre.
English: The most common type of seizures is generalised tonic-clonic seizures, a seizure type which can result in some cases in post-ictal confusion or memory impairment (see section 4.4).
Croatian: Najčešći tip napadaja je generalizirani kloničko-tonički napadaji, vrsta napadaja koja može rezultirati u nekim slučajevima u postiktalnom konfuzijom ili poremećajem pamćenja (vidjeti dio 4.4).
English: Patients who experience dizziness, somnolence, loss of consciousness or seizure should be advised to avoid driving or operating machines until these adverse effects have resolved.
Croatian: Bolesnicima koji dožive omaglicu, somnolenciju, gubitak svijesti ili napadaj treba savjetovati izbjegavanje upravljanja vozilima ili rada sa strojevima sve dok te nuspojave ne prestanu.
English: NB-304 evaluated subjects with type 2 diabetes not achieving glycaemic goal of HbA1c <7% (53 mmol/mol) with oral anti-diabetes agents or on diet and exercise alone.
Croatian: NB-304 je procijenio ispitanike s dijabetesom tipa 2 koji nisu postigli glikemijski cilj od HbA1c < 7 % (53 mmol/mol) s oralnim antidijabeticima ili samo dijetom ili vježbama.
English: Based on its half-life, 6-beta-naltrexol is estimated to reach steady state concentrations in approximately 3 days.
Croatian: Na temelju svog poluvijeka, procjenjuje se da 6-beta-naltreksol dostiže svoju koncentraciju stanja dinamičke ravnoteže za oko 3 dana.
English: Although most subjects recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in subjects ingesting large doses of the drug.
Croatian: Iako se većina ispitanika oporavila bez posljedica, smrti povezane s predoziranjem samo bupropionom su prijavljene u ispitanika koji su uzeli velike doze lijeka.
English: • At the request of the European Medicines Agency;
Croatian: Ažurirani RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove;
English: INFORMATION IN BRAILLE mysimba
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mysimba
English: The types of tolerability events were similar to the events observed in patients with normal renal function (see sections 4.2, 4.4, and 5.2).
Croatian: Vrste događaja podnošljivosti su bile slične događajima uočenih kod bolesnika s normalnom funkcijom bubrega (vidjeti dijelove 4.2, 4.4, i 5.2).
English: • Patients with uncontrolled hypertension (see section 4.4)
Croatian: • Bolesnici s nekontroliranom hipertenzijom (vidjeti dio 4.4)
English: • tramadol (a painkiller belonging to the class of opiates);
Croatian: • tramadol (lijek protiv boli koji pripada skupini opijata);
English: The relevance of these observations to human fertility is not known.
Croatian: Važnost tih opažanja za ljudsku plodnost nije poznata.
English: Other sources of information
Croatian: Drugi izvori i informacija
English: If you feel depressed, contemplate suicide, have a history of attempting suicide or any other mental health problems, you should inform your doctor before taking this medicine.
Croatian: Ako se osjećate depresivno, razmišljate o samoubojstvu, imate povijest pokušaja samoubojstva ili imate neki drugi problem mentalnog zdravlja, morate obavijestiti svog liječnika prije nego uzmete ovaj lijek.