FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: • have low blood pressure, enlarged prostate gland or difficulties passing water because of narrowing of the urethra
Croatian: • ako imate nizak krvni tlak, uvećanu prostatu ili poteškoće s mokrenjem zbog sužene uretre
English: Hallucination
Croatian: Halucinacije
English: No dose modification based on renal function is required but caution is recommended when dosing subjects with severe renal impairment (see section 4.4).
Croatian: Nije potrebna prilagodba doze vezano uz funkciju bubrega, ali se preporučuje oprez kad se doza primjenjuje u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 4.4).
English: Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports.
Croatian: Slučajevi akutnog oštećenja jetre prijavljeni su u ovisnika o opioidima u kliničkim ispitivanjima kao i u prijavama nuspojava nakon stavljanja lijeka u promet.
English: Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome
Croatian: Žutica Hepatička nekroza Hepatorenalni sindrom
English: Intravenous or intranasal misuse of Zubsolv is expected to be less likely than buprenorphine alone since the naloxone in Zubsolv can precipitate withdrawal in individuals dependent on heroin, methadone, or other opioid agonists.
Croatian: Manje je vjerojatna intravenska ili intranazalna pogrešna uporaba lijeka Zubsolv nego samog buprenorfina, s obzirom da nalokson u lijeku Zubsolv može izazvati simptome ustezanja u pojedinaca ovisnih o heroinu, metadonu ili drugim agonistima opioida.
English: Pack-size of 28 (4 x 7) tablets.
Croatian: Veličina pakiranja od 28 (4 x 7) tableta.
English: Pack-size of 7 (1 x 7) tablets.
Croatian: Veličina pakiranja od 7 (1 x 7) tableta.
English: “8.6” on one side
Croatian: „8.6” na jednoj strani
English: Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of buprenorphine/naloxone sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment.
Croatian: Tablica 3 sažeto prikazuje rezultate kliničkog ispitivanja u kojem je izloženost nakon primjene jednokratne doze sublingvalne tablete buprenorfina/naloksona utvrđena u zdravih ispitanika i ispitanika s oštećenjem jetre.
English: Signs of overdose may also include somnolence, amblyopia, miosis, hypotension, nausea, vomiting and/or speech disorders.
Croatian: Znakovi predoziranja također mogu uključivati somnolenciju, ambliopiju, miozu, hipotenziju, mučninu,
English: The other ingredients are mannitol, citric acid anhydrous, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica and sodium stearyl fumarate.
Croatian: Drugi sastojci su manitol, citratna kiselina, bezvodna, natrijev citrat, mikrokristalična celuloza, umrežena karmelozanatrij, sukraloza, levomentol, silicijev dioksid, koloidni, bezvodni i natrijev stearilfumarat.
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Croatian: Poremećaji su se kretali u rasponu od prolaznih asimptomatskih povišenja jetrenih transaminaza do zatajenja jetre, nekroze jetre, hepatorenalnog sindroma, hepatalne encefalopatije i smrti.
English: If you are dependent upon heroin or a short acting opioid, your first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 6 hours after you last used opioids
Croatian: Ako ste ovisni o heroinu ili kratkodjelujućim opioidima, prvu dozu lijeka Zubsolv trebate uzeti kad se pojave znakovi ustezanja, no ne ranije od 6 sati od zadnjeg uzimanja opioida.
English: • weakness, chest pain, chills, fever, feeling of general discomfort, pain, swelling (hands and feet)
Croatian: • slabost, bol u prsnom košu, zimica, vrućica, osjećaj opće nelagode, bol, oticanje (ruku i stopala)
English: Patients who are positive for viral hepatitis, receiving concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Croatian: Bolesnici koji su pozitivni na virusni hepatitis, koji istodobno uzimaju druge lijekove (vidjeti dio 4.5) i/ili imaju postojeći poremećaj jetrene funkcije izloženi su opasnosti od ubrzanog oštećenja jetre.
English: Opioids should be used with caution in patients with myxoedema, hypothyroidism, or adrenal cortical insufficiency (e.g., Addison's disease).
Croatian: Opioide je potrebno koristiti uz oprez u bolesnika s miksedemom, hipotireoidizmom ili insuficijencijom adrenalnog korteksa (npr. Addisonova bolest).
English: Opioids should be used with caution in patients with hypotension, prostatic hypertrophy or urethral stenosis.
Croatian: Opioide je potrebno koristiti uz oprez u bolesnika s hipotenzijom, hipertrofijom prostate ili stenozom uretre.
English: • increased blood pressure, flushing
Croatian: • povišen krvni tlak, navale crvenila
English: • abnormal liver function, weight loss
Croatian: • poremećaj jetrene funkcije, gubitak tjelesne težine
English: Do not swallow or consume food or any drink until the tablet is completely dissolved.
Croatian: Nemojte gutati ili konzumirati hranu ili bilo kakvo piće dok se tableta potpuno ne rastopi.
English: • are debilitated
Croatian: • ako ste u oslabljenom stanju
English: Reproduction studies by oral administration of buprenorphine: naloxone (ratio 1:1) indicated that embryolethality occurred in rats in the presence of maternal toxicity at all doses.
Croatian: Ispitivanja utjecaja na reprodukciju u štakora pokazala su da peroralno primijenjeni buprenorfin i nalokson (u omjeru 1:1) imaju letalne učinke na embrije štakora pri svim maternalno toksičnim dozama.
English: If a patient is changed between buprenorphine or buprenorphine and naloxone containing products, dose adjustments may be necessary due to the potential differences in bioavailability (see sections 4.4 and 5.2).
Croatian: Ako je bolesnik prelazio s lijekova koji sadrže buprenorfin ili buprenorfin i nalokson, možda će biti potrebne prilagodbe doze zbog potencijalnih razlika u bioraspoloživosti (vidjeti dijelove 4.4 i 5.2).
English: • Do not consume any food or drink until the tablets have completely dissolved.
Croatian: • Nemojte konzumirati hranu ili piće dok se tablete potpuno ne otope.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.
Croatian: Istovremena primjena antagonista opioida (naltrekson, nalmefen) za liječenje ovisnosti o alkoholu ili opioidima.
English: “2.9” on one side
Croatian: „2.9” na jednoj strani
English: Abrupt discontinuation of treatment is not recommended as it may result in withdrawal syndrome with delayed onset.
Croatian: Ne preporučuje se nagli prekid terapije, jer on može uzrokovati sindrom ustezanja od lijeka koji može imati odgođeni nastup.
English: • Breathing problems (see also ‘Do not take Zubsolv' above ) Some people have died from respiratory failure (inability to breathe) because they misused this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.
Croatian: Neke su osobe umrle zbog zatajenja disanja (nisu mogle disati), jer su uzele ovaj lijek na pogrešan način ili su ga uzele u kombinaciji s drugim depresorima središnjeg živčanog sustava, kao što su alkohol, benzodiazepini (sredstva za umirenje) ili drugi opioidi.
English: Transaminases increased
Croatian: Povišene vrijednosti transaminaza
English: The lowest dose studied represented exposure multiples of 1x for buprenorphine and 5 x for naloxone at the maximum human therapeutic dose calculated on a mg/m² basis.
Croatian: Najniža ispitivana doza kojoj su štakori bili izloženi odgovarala je umnošcima od 1x izloženosti za buprenorfin i 5x za nalokson pri maksimalnoj terapijskoj dozi za ljude izračunate na temelju mg/m².
English: Overall, buprenorphine plasma exposure increased approximately 3-fold in patients with severely impaired hepatic function, while naloxone plasma exposure increased 14-fold with severely impaired hepatic function.
Croatian: Sveukupno, izloženost buprenorfina u plazmi povećana je približno 3 puta, a izloženost naloksona u plazmi povećana je 14 puta u bolesnika s teškim oštećenjem jetre.
English: • abnormal blood tests swollen, glands (lymph nodes)
Croatian: • neuobičajeni rezultati krvnih pretraga, otečene žlijezde (limfni čvorovi)
English: Amnesia Hyperkinesia Seizure
Croatian: Amnezija Hiperkinezija Napadaji
English: “11.4” on one side
Croatian: „11.4” na jednoj strani
English: Combining buprenorphine with naloxone in Zubsolv is intended to deter misuse and abuse of the buprenorphine.
Croatian: Kombiniranje buprenorfina s naloksonom u lijeku Zubsolv namijenjeno je odvraćanju od pogrešne uporabe i zlouporabe buprenorfina.
English: Very common side effects (may affect more than one in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: Zubsolv sublingual tablets should be used with caution in patients with moderate hepatic impairment (see sections 4.2 and 5.2).
Croatian: Zubsolv sublingvalne tablete trebaju se primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre (vidjeti dijelove 4.2 i 5.2).
English: Less than daily dosing
Croatian: Doziranje rjeđe od jednom dnevno
English: • pain and sores in mouth, tongue discolouration
Croatian: • bol i ranice u ustima, promjena boje jezika
English: Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na poseban i ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio
English: Patients should not swallow or consume food or drink until the tablet is completely dissolved.
Croatian: Bolesnici ne smiju gutati niti konzumirati hranu ili tekućinu dok se tableta u potpunosti ne otopi.
English: How Zubsolv works
Croatian: Kako Zubsolv djeluje
English: The tablet is to be placed under the tongue until completely dissolved.
Croatian: Tableta se treba držati pod jezikom dok se potpuno ne otopi.
English: A reduction of the buprenorphine/naloxone dose may be needed.
Croatian: Stoga može biti potrebno sniziti dozu buprenorfina/naloksona.
English: In patients with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone (see sections 4.2 and 4.4).
Croatian: U bolesnika s izraženom ovisnosti o lijeku, početna primjena buprenorfina može uzrokovati sindrom ustezanja od lijeka sličan onom uzrokovanom primjenom naloksona (vidjeti dijelove 4.2 i 4.4).
English: • severe tiredness, itching with yellowing of skin or eyes.
Croatian: • jak umor, svrbež sa žutom bojom kože ili očiju.
English: There are no adequate data from the use of buprenorphine/naloxone in pregnant women.
Croatian: Nema podataka o primjeni buprenorfina/naloksona u trudnica.
English: Buprenorphine is a partial agonist at the μ (mu)-opiate receptor and chronic administration produces dependence of the opioid type.
Croatian: Buprenorfin je parcijalni agonist µ (mi)-opioidnih receptora i kronična primjena dovodi do ovisnosti opioidnog tipa.
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated dose multiples of 3 to75 times, based on a Zubsolv equivalent human daily sublingual dose of 11.4 mg of buprenorphine calculated on a mg/m² basis.
Croatian: Ispitivanje kancerogenosti buprenorfina/naloksona provedeno je na štakorima s dozama od 7, 30 i 120 mg/kg/dan, čime su štakori bili izloženi 3 do 75 puta višoj dozi, s obzirom na dnevnu sublingvalnu dozu ekvivalenta Zubsolva buprenorfina za ljude od 11,4 mg izračunatu na temelju mg/m².
English: It is unknown whether naloxone/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se nalokson/metaboliti u majčino mlijeko.
English: • protein in your urine, urinary tract infection, difficulty urinating, painful or difficult urination,
Croatian: • nalaz proteina u urinu, infekcija mokraćnih puteva, bolno ili otežano mokrenje, krv u mokraći,
English: Tell your doctor if you are pregnant or intend to become pregnant.
Croatian: Ako ste trudni ili planirate trudnoću obavijestite svog liječnika.
English: • Keep the tablets in place under the tongue until they have completely dissolved
Croatian: • Držite tablete na mjestu pod jezikom sve dok se potpuno ne otope.
English: • Blood pressure
Croatian: • Krvni tlak
English: If you forget to take Zubsolv
Croatian: Ako ste zaboravili uzeti Zubsolv
English: • rapid or slow heartbeat, myocardial infarction (heart attack), palpitations, chest tightness
Croatian: • ubrzani ili usporeni otkucaji srca, infarkt miokarda (srčani udar), osjećaj lupanja srca, stezanje u prsnom košu
English: “5.7” on one side
Croatian: „5.7” na jednoj strani
English: For subjects randomised to either active treatment, dosing began with 8 mg of buprenorphine on Day 1, followed by 16 mg (two 8 mg) of buprenorphine on Day 2.
Croatian: Za ispitanike randomizirane u jednu od dvije skupine koje su primale djelatnu tvar, doziranje je započelo s 8 mg buprenorfina 1. dana, a 2. dana ispitanici su dobili 16 mg (dvaput po 8 mg) buprenorfina.
English: Buprenorphine, when taken orally, undergoes first-pass metabolism with N-dealkylation and glucuroconjugation in the small intestine and the liver.
Croatian: Kad se uzima peroralno, buprenorfin se metabolizira pri prvom prolasku N-dealkilacijom i konjugacijom s glukuronskom kiselinom u tankom crijevu i jetri.
English: Warnings and precautions • Misuse, abuse and diversion
Croatian: Upozorenja i mjere opreza • Pogrešna uporaba, zlouporaba i uporaba lijeka u svrhe za koje nije namijenjen
English: In comparative bioavailability studies Zubsolv 11.4/2.9 mg displayed equivalent buprenorphine exposure to 16/4mg (2 x 8/2mg) buprenorphine/naloxone administered as conventional sublingual tablets however Zubsolv 2 x 1.4/0.36 mg displayed 20% lower buprenorphine exposure to 2 x 2/0.5 mg buprenorphine/naloxone administered as conventional sublingual tablets.
Croatian: U ispitivanjima usporedivosti bioraspoloživosti, Zubsolv 11,4/2,9 mg pokazao je ekvivalentnu izloženost buprenorfina u odnosu na 16/4 mg (2 x 8/2 mg) buprenorfina/naloksona primijenjenih kao konvencionalne sublingvalne tablete, no Zubsolv 2 x 1,4/0,36 mg pokazali su 20 % nižu izloženost buprenorfina u odnosu na 2 x 2/0,5 mg buprenorfina/naloksona primijenjenih kao konvencionalne sublingvalne tablete.
English: Both active substances of Zubsolv, buprenorphine and naloxone, are extensively metabolized in the liver, and the plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment.
Croatian: Obje djelatne tvari lijeka Zubsolv, buprenorfin i nalokson, opsežno se metaboliziraju u jetri i utvrđeno je da su njihove izmjerene razine u plazmi više u bolesnika s umjerenim i teškim oštećenjem jetre.
English: Abnormal dreams Agitation Apathy
Croatian: Agitacija Apatija
English: The reduced level of alertness can make driving and using machines hazardous
Croatian: Smanjenja razina pažnje može povećavati rizik pri upravljanju vozilima i strojevima.
English: Stopping treatment suddenly may cause withdrawal symptoms.
Croatian: Nagli prekid liječenja može prouzročiti simptome ustezanja lijeka.
English: Therefore, patients should be monitored when changing between different buprenorphine containing products as differences in bioavailability (see section 5.2) may be noticeable in some individual cases.
Croatian: Zato je potrebno pratiti bolesnike kada prelaze s jednog lijeka koji sadrži buprenorfin na drugi, budući da u pojedinim slučajevima može biti zamjetnih razlika u bioraspoloživosti (vidjeti dio 5.2).
English: Zubsolv tablet description Zubsolv tablet debossing
Croatian: Opis Zubsolv tablete Utisnuta oznaka Zubsolv tablete
English: Table 1: Treatment related adverse reactions reported in clinical trials and post-marketing surveillance of buprenorphine/naloxone
Croatian: Tablica 1: Nuspojave vezane uz liječenje, prijavljene u kliničkim ispitivanjima i nuspojave zabilježene nakon stavljanja buprenorfina/naloksona u promet Klasa sustava organa
English: An additional Zubsolv 1.4 mg / 0.36 mg or 2.9 mg / 0.71 mg may be administered on day one depending on the individual patient's requirement.
Croatian: Dodatna doza lijeka Zubsolv od 1,4 mg / 0,36 mg ili 2,9 mg / 0,71 mg može se primijeniti prvog dana ovisno o potrebama pojedinog bolesnika.
English: Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2).
Croatian: Buprenorfin/nalokson kontraindiciran je u bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.3 i 5.2).
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent patients.
Croatian: U ispitivanjima kliničke farmakologije primijećeni su „učinci plafona” uz opioidne agoniste u bolesnika ovisnih o opioidima.
English: Starting treatment
Croatian: Početak liječenja
English: one tablet of Zubsolv 1.4 mg / 0.36 mg each day, or
Croatian: - jedna tableta lijeka Zubsolv 1,4 mg / 0,36 mg svaki dan ili
English: • Withdrawal symptoms
Croatian: • Simptomi ustezanja
English: A patent airway and assisted or controlled ventilation must be assured.
Croatian: Mora se osigurati prohodnost dišnih puteva te asistirano ili kontrolirano disanje.
English: “1.4” on one side
Croatian: „1.4” na jednoj strani
English: The concomitant use of monoamine oxidase inhibitors (MAOI) might produce an exaggeration of opioid effects, based on experience with morphine (see section 4.5).
Croatian: Na temelju iskustva s morfijem, istovremena primjena inhibitora monoaminooksidaze (MAOI) može pojačati učinke opioida (vidjeti dio 4.5).
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone should be undertaken when objective signs of withdrawal are evident (see section 4.2).
Croatian: Da bi se izbjeglo izazivanje simptoma ustezanja, uvođenje buprenorfina/naloksona treba se poduzeti nakon očitih objektivnih simptoma ustezanja (vidjeti dio 4.2).
English: Heat stroke
Croatian: Toplinski udar
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.4 and 5.2).
Croatian: Preporučuje se oprez pri doziranju u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.4 i 5.2).
English: The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly
Croatian: U skladu s tim potrebno je prilagoditi dozu buprenorfina ili induktora CYP3A4.
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2).
Croatian: Preporučuje se oprez pri doziranju u bolesnika s teškim oštećenjem bubrega (klirens kreatinina <30 ml/min) (vidjeti dijelove 4.2 i 5.2).
English: The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone were evaluated in a post-marketing study.
Croatian: Učinak oštećenja jetre na farmakokinetiku buprenorfina i naloksona procijenjen je u ispitivanju nakon stavljanja lijeka u promet.
English: Keep the tablet under your tongue until it dissolves.
Croatian: Tabletu držati pod jezikom dok se ne rastopi.
English: 2.8-fold increase
Croatian: 4.8 Nuspojave
English: Not all strengths and pack-sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve jačine.
English: It also contains naloxone which is used to deter intravenous abuse of the product.
Croatian: Sadrži i nalokson koji se primjenjuje za odvraćanje od intravenske zlouporabe ovog lijeka.
English: The first dose of Zubsolv should be taken when signs of withdrawal appear, but not less than 24 hours after you last used methadone
Croatian: Prvu dozu lijeka Zubsolv trebate uzeti kad se pojave znakovi ustezanja, no ne ranije od 24 sata od zadnjeg uzimanja metadona.
English: Zubsolv tablet strength
Croatian: Jačina Zubsolv tablete
English: Mouth ulceration Tongue discolouration
Croatian: Ulceracije u ustima
English: • flu-like symptoms, infection, sore throat and painful swallowing, runny nose
Croatian: • simptomi nalik gripi, infekcija, grlobolja i bolno gutanje, curenje iz nosa
English: Precipitation of opioid withdrawal syndrome
Croatian: Izazivanje sindroma ustezanja od opioida
English: • asthma, shortness of breath, yawning
Croatian: • astma, nedostatak zraka, zijevanje
English: Below is a list of examples of these types of medicines: - other opioid containing medicines such as methadone, certain pain killers and cough suppressants - some anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors (MAOIs) may increase the effects of this medicine - sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine - barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital - tranquilisers (used to cause sleep or sedation) such as chloral hydrate - clonidine (used to treat high blood pressure) and related medicines may extend the effects of this medicine
Croatian: U nastavku se nalazi popis primjera ovih vrsta lijekova: - drugi opioidi koji sadrže lijekove poput metadona, određeni lijekovi protiv boli i lijekovi protiv kašlja - neki antidepresivi (koriste se za liječenje depresije) poput izokarboksazida, fenelzina, selegilina, tranilcipromina, valproata i inhibitora monoaminooksidaze (MAOI) koji mogu povećati učinak ovog lijeka
English: The first dose of buprenorphine/naloxone should be taken only when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.
Croatian: Prvu dozu buprenorfina/naloksona treba uzeti tek kad se pojave znakovi ustezanja, ali ne prije nego što je proteklo 24 sata nakon što je bolesnik zadnji put uzeo metadon.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: Orthostatic hypotension
Croatian: Ortostatska hipotentzija
English: • have under-active thyroid gland which can cause tiredness or weight gain
Croatian: • ako imate smanjenju aktivnost štitne žlijezde, što može uzrokovati umor ili debljanje
English: • benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Croatian: Zubsolv treba koristiti uz oprez kod istovremene primjene s: • benzodiazepinima: Ova kombinacija može dovesti do smrti zbog depresije disanja središnjeg podrijetla.
English: • abdominal pain, upset stomach or other stomach discomfort, diarrhoea, flatulence, vomiting
Croatian: • bol u trbuhu, nadražen želudac ili druge nelagode želudca, proljev, vjetrovi, povraćanje
English: Since both buprenorphine and naloxone are extensively metabolized in liver, plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment after single-dose administration.
Croatian: S obzirom da se buprenorfin i nalokson opsežno metaboliziraju u jetri, njihova izmjerena razina u plazmi bila je viša u bolesnika s umjerenim i teškom oštećenjem jetre nakon primjene jednokratne doze.
English: Speech disorder Tremor
Croatian: Poremećaj govora
English: • constipation, nausea
Croatian: • zatvor, mučnina