FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific antidotes for combined use of bupropion and naltrexone are known.
Croatian: Nisu poznati specifični antidoti kombinirane uporabe bupropiona i naltreksona.
English: Adverse reactions reported in subjects who received Naltrexone/Bupropion as a fixed-dose combination
Croatian: Nuspojave prijavljene u ispitanika koji su primali naltrekson/bupropion, kao fiksnu kombinaciju MedDRA - klasifikacije organskih sustava
English: In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced, as these patients may have higher drug concentrations which could result in an increase in adverse drug reactions (see sections 4.2, 4.8, and 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem bubrega, maksimalnu preporučenu dnevnu dozu naltreksona / bupropiona potrebno je smanjiti jer ti bolesnici mogu imati povećane koncentracije lijeka što može dovesti do porasta nuspojava (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Diarrhoea, Flatulence, Haemorrhoids , Ulcer
Croatian: Učestalost Nuspojava (lijek*) nepoznato dijareja, flatulencija, hemoroidi, ulkus
English: Effects on glycaemic control in obese subjects with type 2 diabetes After 56 weeks of treatment in subjects with type 2 diabetes (NB-304), naltrexone / bupropion exhibited improvements in glycaemic control parameters compared to placebo (Table 5).
Croatian: Nakon 56 tjedana liječenja u bolesnika s dijabetesom tipa 2 (NB-304), naltrekson / bupropion je pokazao poboljšanja parametara glikemijske kontrole u usporedbi s placebom (Tablica 5).
English: Mechanism of action and pharmacodynamic effects The exact neurochemical appetite suppressant effects of naltrexone / bupropion are not fully understood.
Croatian: Točni neurokemijski učinci naltrekson / bupropiona na suzbijanje apetita nisu u potpunosti razjašnjeni.
English: Naltrexone and bupropion are well absorbed from the gastrointestinal tract (>90% absorbed), however, naltrexone has a significant first pass effect thereby limiting systemic bioavailablity, with only 5-6% reaching the systemic circulation intact.
Croatian: međutim, naltrekson ima značajan učinak prvog prolaska čime se ograničava sistemska bioraspoloživost, sa samo 5-6 % u sistemskoj cirkulaciji u nepromijenjenom obliku.
English: For individuals who are at elevated risk for renal impairment, in particular patients with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion.
Croatian: Za osobe u kojih je rizik od oštećenja bubrega povećan, naročito u bolesnika s dijabetesom ili starijih osoba, procijenjena brzina glomerularne filtracije se mora utvrditi prije početka liječenja s naltrekson / bupropionom.
English: Do not cut, chew or crush.
Croatian: Ne smijete rezati, žvakati, ili drobiti.
English: There have also been cases of elevated liver enzymes from post-marketing reporting.
Croatian: Nakon stavljanja lijeka u promet, također su prijavljeni slučajevi povećanja razine jetrenih enzima.
English: How to take Mysimba
Croatian: Kako uzimati lijek Mysimba
English: Hepatic impairment: A single-dose pharmacokinetic study has been conducted with naltrexone / bupropion in patients with hepatic impairment.
Croatian: Oštećenje jetre: Provedena su farmakokinetička ispitivanja jedne doze naltreksona / bupropiona u bolesnika s oštećenjem jetre.
English: Cysteine Hydrochloride Microcrystalline Cellulose Hydroxypropyl Cellulose Magnesium Stearate
Croatian: Jezgra tablete: cisteinklorid celuloza, mikrokristalična hidroksipropilceluloza magnezijev stearat laktoza, bezvodna laktoza hidrat krosprovidon vrste
English: Of the subjects with observed data at Week 16 in the four Phase 3 clinical trials, 50.8% of those randomized to receive naltrexone / bupropion had lost ≥5% of their baseline body weight, compared to
Croatian: Od ispitanika s opaženim podacima 16. tjedna u četiri klinička ispitivanja faze 3, 50,8 % randomiziranih za primanje naltrekson / bupropiona izgubilo je ≥ 5 % svoje početne tjelesne težine, u usporedbi s 19,3 % u ispitanika koji su primali placebo (koji su odgovorili na liječenje u 16. tjednu).
English: Data summaries for mean change in body weight reflect the Intent-to-Treat (ITT) population, defined as subjects who were randomized, had a baseline body weight measurement, and had at least one post-baseline body weight measurement during the defined treatment phase, using a last observation carried forward (LOCF)
Croatian: Intent-to-Treat, ITT), definiranu kao ispitanici koji su bili randomizirani i imali su mjerenje tjelesne težine na početku te barem jedno mjerenje tjelesne težine nakon početnog tijekom definirane faze liječenja, pomoću analize zadnjeg zapažanja prenesenog dalje
English: Adverse reactions of the individual components Naltrexone and Bupropion identified in the respective approved SmPCs.
Croatian: Nuspojave prijavljene za pojedinačne komponente naltrekson i bupropion navedene u njihovim odobrenim sažecima opisa svojstava lijeka.
English: There are no data on fertility from the combined use of naltrexone and bupropion.
Croatian: Nema podataka o plodnosti s kombiniranom primjenom naltreksona i bupropiona.
English: • Week 1: One tablet in the morning
Croatian: • 1. tjedan: jedna tableta ujutro
English: Each tablet contains 8 milligrams of naltrexone hydrochloride, equivalent to 7.2 milligrams of naltrexone, and 90 milligrams of bupropion hydrochloride, equivalent to 78 milligrams of bupropion.
Croatian: Jedna tableta sadrži 8 miligrama naltreksonklorida, što odgovara 7,2 miligrama naltreksona i 90 miligrama bupropionklorida, što odgovara 78 miligrama bupropiona.
English: • Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening
Croatian: • 4. tjedan i nadalje: dvije tablete dva puta na dan, dvije ujutro i dvije navečer
English: If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Lijek Mysimba sadrži laktozu (vrsta šećera) Ako Vam je rečeno da ne podnosite neke šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
English: Change in Cardiovascular and Metabolic Parameters from Baseline to Week 56 in Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Croatian: Promjene kardiovaskularnih i metaboličkih parametara od početka do 56. tjedna u ispitivanjima faze 3 NB-301, NB-302, i NB-304, i od početka do 28. tjedna u ispitivanju faze 3 NB-303.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Inhibitori monoaminooksidaze (MAOI)
English: In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see sections 4.4 and 5.2).
Croatian: U bolesnika s blagim oštećenjem jetre, najviša preporučena dnevna doza naltreksona / bupropiona je dvije tablete (jedna ujutro i jedna uvečer) (vidjeti dijelove 4.4 i 5.2).
English: There are no or limited amounts of data from the use of naltrexone / bupropion in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni naltrekson / bupropiona u trudnica ograničeni.
English: Loss + With baseline observation carried forward (BOCF) ++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment.
Croatian: S početnim zapažanjem prenesenim dalje (BOCF) ++ Ispitanici kojima je mjerena početna i tjelesna težina nakon početne i završili su liječenje od 56 tjedana (ispitivanja NB-301, NB-302, i NB-304) ili 28 tjedana (NB-303).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release MIAS Pharma Ltd
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(odgovornih) za puštanje serije lijeka u promet
English: • quinolones (antibiotics such as ciprofloxacine to treat infections);
Croatian: • lijekovi koji se koriste za sprječavanje malarije; • kinoloni (antibiotici poput ciprofloksacina za liječenje infekcija);
English: Naltrexone / bupropion is contraindicated in patients with end-stage renal failure.
Croatian: Naltrekson / bupropion je kontraindiciran u bolesnika sa završnim stadijem zatajenja bubrega.
English: Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion.
Croatian: Jedna tableta sadrži 8 mg naltreksonklorida, što odgovara 7,2 mg naltreksona i 90 mg bupropionklorida, što odgovara 78 mg bupropiona.
English: • Week 1: One tablet once a day in the morning
Croatian: • 1. tjedan: jedna tableta jedanput na dan ujutro
English: Mean Weight Loss (% Change) from Baseline to Week 56 in Naltrexone / Bupropion (NB) Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Croatian: Srednja vrijednost gubitka težine (% promjene) od početka do 56. tjedna u ispitivanjima faze 3 s naltrekson / bupropionom (NB) NB-301, NB-302, i NB-304 i od početka do 28. tjedna u ispitivanju faze 3 NB-303
English: Naltrexone / bupropion is not recommended in patients with moderate hepatic impairment (see sections 4.4 and 5.2).
Croatian: Naltrekson / bupropion se ne preporučuje bolesnicima s umjerenim oštećenjem jetre (vidjeti dijelove 4.4. i 5.2).
English: • Week 3: Three tablets every day, two in the morning and one in the evening
Croatian: • 3. tjedan: tri tablete svaki dan, dvije ujutro i jedna navečer
English: Baseline (kg)
Croatian: Početna vrijednost (kg)
English: Cough, Dysphonia, Dyspnoea, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sinus disorder, Sneezing, Yawning
Croatian: prsišta i sredoprsja nepoznato kašalj, disfonija, dispneja, nazalna kongestija, nazalna nelagoda, orofaringealna bol, rinoreja, poremećaj sinusa, kihanje, zijevanje
English: Affective disorders, Aggression, Confusional state, Delusions, Depression, Disorientation, Disturbance in attention, Hostility, Loss of libido, Nightmares, Paranoia, Psychotic disorder, Suicidal ideation*, Suicide attempt, Suicidal behaviour
Croatian: rijetko halucinacije nepoznato afektivni poremećaji, agresija, konfuzno stanje, deluzije, depresija, dezorijentiranost, poremećaj pažnje, neprijateljstvo, gubitak libida, noćne more,
English: Naltrexone / bupropion has not been extensively evaluated in subjects with hepatic impairment.
Croatian: Naltrekson / bupropion nije opsežno ispitan u ispitanika s oštećenjem jetre.
English: Uncommon Abnormal dreams, Agitation, Mood swings, Nervousness, Tension, Dissociation (feeling spacey)
Croatian: nervoza, napetost, disocijacija (osjećaj odvojenosti)
English: • you have any kidney problems before you start Mysimba.
Croatian: • imate bilo kakvih problema s bubrezima prije nego što počnete uzimati lijek Mysimba.
English: Completers Analysis Set++ N
Croatian: Ispitanici koji završili ispitivanje++
English: • Week 2: One tablet twice a day, one in the morning and one in the evening
Croatian: • 2. tjedan: jedna tableta dva puta na dan, jedna ujutro i jedna navečer
English: Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3) and is not recommended in patients with moderate hepatic impairment (see section 4.4).
Croatian: Naltrekson / bupropion je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3) i ne preporučuje se u bolesnika s umjerenim oštećenjem jetre (vidjeti dio 4.4).
English: Concentration disturbance (B)
Croatian: Psihijatrijski poremećaji često poremećaj koncentracije (B)
English: NB-303 NB PBO NB PBO NB PBO NB PBO Randomized Population+ N ≥5% Weight Loss
Croatian: NB PBO NB PBO NB PBO NB PBO Randomizirana populacija+
English: NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
Croatian: Mysimba 8 mg / 90 mg tablete s produljenim oslobađanjem naltreksonklorid / bupropionklorid
English: ++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment.
Croatian: Ispitanici kojima je mjerena početna i tjelesna težina nakon početne i koji su završili liječenje od 56 tjedana (ispitivanja NB-301, NB-302, i NB-304) ili 28 tjedana (NB-303).
English: • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight (see Section 5.1).
Croatian: • ≥ 27 kg/m2 do < 30 kg/m2 (prekomjerna tjelesna težina) u prisustvu jedne ili više bolesti povezane s težinom (npr. dijabetes tipa 2, dislipidemija, ili kontrolirana hipertenzija)
English: • Week 2: One tablet in the morning and one tablet in the evening
Croatian: • 2. tjedan: jedna tableta ujutro i jedna tableta navečer
English: How to store Mysimba
Croatian: Kako čuvati lijek Mysimba
English: • Patients with severe hepatic impairment (see sections 4.2 and 5.2) • Patients with end-stage renal failure (see sections 4.2 and 5.2)
Croatian: • Bolesnici sa završnim stadijem zatajenja bubrega (vidjeti dijelove 4.2 i 5.2).
English: The effects of combined bupropion and naltrexone use have not been studied in animals.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Učinci kombinirane uporabe bupropiona i naltreksona nisu ispitivane u životinja.
English: • Week 3: Two tablets in the morning and one tablet in the evening
Croatian: • 3. tjedan: dvije tablete ujutro i jedna tableta navečer
English: The incidence of seizure in subjects receiving naltrexone / bupropion in clinical trials was approximately 0.06% (2/3239 subjects) vs. 0.0% (0/1515 subjects) on placebo.
Croatian: (2/3239 ispitanika) naspram 0,0 % (0/1515 ispitanika) na placebu.
English: Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment, and not recommended in patients with moderate hepatic impairment (see sections 4.2 4.3, and 5.2).
Croatian: Naltrekson / bupropion je kontraindiciran u bolesnika s teškim oštećenjem jetre, i ne preporučuje se u bolesnika s umjerenim oštećenjem jetre (vidjeti dijelove 4.2, 4.3, i 5.2).
English: Naltrexone is primarily metabolized to 6-beta-naltrexol by the dihydrodiol dehydrogenases (DD1, DD2 and DD4).
Croatian: Naltrekson se prvenstveno metabolizira u 6-beta-naltreksol pomoću dihidrodiol dehidrogenaza
English: In patients requiring intermittent opiate treatment, naltrexone / bupropion therapy should be temporarily discontinued and opiate dose should not be increased above the standard dose.
Croatian: bupropionom treba privremeno prekinuti, a dozu opijata se ne smije povisiti iznad standardne doze.
English: LDL-C/HDL-C ratio
Croatian: LDL-K/HDLK omjer
English: Uncommon Delusions (B), Depersonalisation (B), Libido disorder (N), Paranoid ideation (B)
Croatian: poremećaj libida (N), paranoja (B)
English: Do not take Mysimba: - if you are allergic to naltrexone, to bupropion or to any of the other ingredients of this medicine
Croatian: - ako ste alergični na naltrekson, na bupropion ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.);
English: Elderly patients may be more sensitive to the central nervous system adverse reactions of naltrexone / bupropion.
Croatian: Stariji bolesnici mogu biti osjetljiviji na nuspojave na naltrekson / bupropion u središnjem živčanom sustavu.
English: In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Croatian: U bolesnika s blagim oštećenjem jetre preporučena najviša dnevna doza naltreksona / bupropiona mora se smanjiti (vidjeti dio 4.2).
English: Lactose Monohydrate Crospovidone type A Indigo Carmine Aluminium Lake (E132) Hypromellose
Croatian: A indigo carmine aluminium lake (E132) hipromeloza dinatrijev edetat silicijev dioksid, koloidni
English: Naltrexone / bupropion must not be administered to patients receiving chronic opiate therapy (see section 4.3).
Croatian: Bolesnici koji primaju opioidne analgetike Naltrekson / bupropion se ne smije davati bolesnicima koji primaju kroničnu terapiju opijatima (vidjeti dio 4.3).
English: The incidence of severe nausea, severe constipation, and severe vomiting was low, but was higher in subjects treated with naltrexone / bupropion compared to subjects treated with placebo (severe nausea: naltrexone / bupropion 1.9%, placebo <0.1%; severe constipation: naltrexone / bupropion 0.6%, placebo 0.1%; severe vomiting: naltrexone / bupropion 0.7%, placebo 0.3%).
Croatian: (teška mučnina: naltrekson / bupropion 1,9 %, placebo < 0,1 %; težak zatvor: naltrekson / bupropion 0,6 %, placebo 0,1 %, teško povraćanje: naltrekson / bupropion 0,7 %, placebo 0,3 %).
English: PharmaSwiss d.o.o.
Croatian: PharmaSwiss Hellas A.E.
English: Uncommon Ataxia (B), Incoordination (B)
Croatian: Poremećaji živčanog sustava manje često ataksija (B), nekoordiniranost (B)
English: Uncommon Visual disturbance (B)
Croatian: Poremećaji oka manje često poremećaj vida (B)
English: NB-303 NB PBO NB PBO NB PBO NB PBO Intent-to-Treat Analysis Set+ N Baseline (kg) LS Mean (95% CI)
Croatian: NB-303 NB PBO NB PBO NB PBO NB PBO Komplet potpune analize+
English: Palpitations, Heart rate increased Uncommon Tachycardia
Croatian: Srčani poremećaji često palpitacije, ubrzan rad srca manje često tahikardija
English: You will have your blood pressure and heart rate measured before you start taking Mysimba and while you are taking it.
Croatian: Prije nego što počnete uzimati lijek Mysimba i dok ga uzimate mjerit će Vam se krvni tlak i puls.
English: Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment (see section 4.3).
Croatian: Naltrekson / bupropion je kontraindiciran u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme including certain antidepressants (SSRIs and many tricyclic antidepressants, e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product.
Croatian: Istodobnoj primjeni bupropiona s lijekovima koji se metaboliziraju putem CYP2D6 izoenzima uključujući određene antidepresive (selektivne inhibitore ponovne pohrane serotonina i mnoge tricikličke antidepresive, npr. dezipramin, imipramin, paroksetin), antipsihotike (npr. haloperidol,
English: Naltrexone / bupropion is contraindicated in patients with end-stage renal failure (see section 4.3).
Croatian: Naltrekson / bupropion je kontraindiciran u bolesnika sa završnim stadijem zatajenja bubrega (vidjeti dio 4.3).
English: Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnoea requiring medical treatment have been reported in clinical trials with bupropion.
Croatian: U kliničkim ispitivanjima s bupropionom su prijavljene anafilaktoidne / anafilaktičke reakcije okarakterizirane simptomima kao što su pruritus, urtikarija, angioedem, i dispneja koji su zahtijevali liječenje.
English: The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers.
Croatian: Učinci pušenja cigareta na farmakokinetiku bupropiona su ispitivani u 34 zdravih ženskih i muških dobrovoljaca; 17 su bili kronični pušači cigareta a nepušača je bilo 17. Nakon peroralne primjene jedne doze od 150 mg bupropionklorida, nije bilo statistički značajne razlike u Cmax, poluvijeku, Tmax, AUC ili klirensu bupropiona ili njegovih aktivnih metabolitima između pušača i nepušača.
English: Since bupropion is extensively metabolised, caution is advised when naltrexone / bupropion is co-administered with medicinal products known to induce CYP2B6 (e.g., carbamazepine, phenytoin, ritonavir, efavirenz) as these may affect the clinical efficacy of naltrexone / bupropion.
Croatian: Budući da se bupropion opsežno metabolizira, potreban je oprez kada se naltrekson / bupropion primjenjuju istodobno s lijekovima za koje se zna da induciraju CYP2B6 (npr. karbamazepin, fenitoin,
English: Uncommon Postural hypotension (B), Vasodilatation (B)
Croatian: Krvožilni poremećaji manje često posturalna hipotenzija (B), vazodilatacija (B)
English: Naltrexone / bupropion has not been extensively evaluated in subjects with renal insufficiency.
Croatian: Naltrekson / bupropion nije opsežno ocijenjen u ispitanika s insuficijencijom bubrega.
English: Fits (seizures)
Croatian: - koprivnjača (urtikarija)
English: Taste disorders (B)
Croatian: Klasifikacija organskih sustava Učestalost Nuspojava (B)
English: Drug induced liver injury
Croatian: Bolesnici s oštećenjem jetre
English: Metabolism and Nutrition Disorders
Croatian: Poremećaji metabolizma i prehrane rijetko dehidracija
English: • Patients currently dependent on chronic opioids (see sections 4.4 and 4.5) or opiate agonists
Croatian: • Bolesnici trenutno ovisni o kroničnoj primjeni opioida (vidjeti dijelove 4.4 i 4.5) ili agonistima opijata (npr. metadon) ili bolesnici u akutnom ustezanju od opijata • Bolesnici koji primaju istodobno inhibitore monoaminooksidaze (MAOI).
English: - if you have a condition that causes fits (seizures) or if you have a history of fits; - if you have a brain tumour; - if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Mysimba; - if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines), or if you are going to stop them while you are taking Mysimba; - if you have a bipolar disorder (extreme mood swings); - if you are using any other medicines which contain bupropion or naltrexone; - if you have an eating disorder or had one in the past (for example, bulimia or anorexia nervosa); - if you are currently dependent on chronic opiates or opiate agonists (for example methadone), or you are going through acute withdrawal (cold turkey); - if you are taking medicines for depression or Parkinson's disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days; - if you have severe liver disease; - if you have endstage kidney disease.
Croatian: ili prolazite kroz akutno ustezanje; - ako uzimate lijekove za depresiju ili Parkinsonovu bolest pod nazivom inhibitori monoaminooksidaze (MAOI), ili ste ih uzeli u posljednjih 14 dana; - ako imate tešku bolest jetre; - ako imate završni stadij bolesti bubrega.
English: Early, transient mean increases from baseline in systolic and diastolic blood pressure of up to 1 mmHg were observed in naltrexone / bupropion Phase 3 clinical trials.
Croatian: U kliničkim ispitivanjima faze 3 s naltrekson /bupropionom opaženo je rano, prolazno povišenje srednje vrijednosti sistoličkog i dijastoličkog krvnog tlaka u odnosu na početne vrijednosti do 1 mmHg.
English: Blood and Lymphatic System Disorders Rare
Croatian: Poremećaji krvi i limfnog sustava rijetko smanjen hematokrit, smanjen broj limfocita nepoznato limfadenopatija
English: Submission of final study report by 31
Croatian: Dostaviti konačno izvješće ispitivanja do 31. ožujka 2022.
English: There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the management of combined use of bupropion and naltrexone overdoses.
Croatian: hemoperfuzije ili zamjenske transfuzije u liječenju predoziranja kombinirane uporabe bupropiona i naltreksona.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Tablet core:
Croatian: PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA