FrancophonIA/ELRC3.0 huggingface dataset:
English: Suboxone is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Croatian: Suboxone se koristi u odraslih osoba i adolescenata starijih od 15 godina, koji također primaju medicinsku, socijalnu i psihološku pomoć.
English: The patient should be transferred to an environment within which full resuscitation facilities are available.
Croatian: Bolesnika treba premjestiti na odjel gdje postoji kompletna oprema za oživljavanje.
English: 2 - Remove just one section from the blister pack, tearing it along the perforated line.
Croatian: 2 - Odvojite samo jedan odjeljak od blistera, kidajući ga uzduž perforirane linije.
English: Content of the pack and other Information
Croatian: Sadržaj pakiranja i druge informacije
English: No synergistic enhancement of toxicity has been observed.
Croatian: Nije primjećeno sinergističko pojačanje toksičnosti.
English: • any liver disease such as hepatitis
Croatian: • bilo koju bolest jetre poput hepatitisa
English: This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative medicines when you take Suboxone.
Croatian: Do ovog može doći češće u prvih nekoliko tjedana liječenja kada Vam se mijenja doza, no također se može pojaviti ako uz Suboxone konzumirate alkohol ili uzimate druge sedative.
English: • Do not chew or swallow the tablets, as the medicine will not work and you may get withdrawal symptoms.
Croatian: • Nemojte žvakati ili gutati tablete, jer lijek neće djelovati i možete imati simptome ustezanja.
English: If you have the impression that the effect of Suboxone is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako imate dojam da je učinak lijeka Suboxone prejak ili preslab, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: When a hepatic event is suspected, further biological and etiological evaluation is required.
Croatian: Kad se sumnja na jetreni događaj, potrebna su daljnja biološka i etiološka ispitivanja.
English: The frequency of possible side effects listed below is defined using the following convention: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100), Not known (cannot be estimated from available data).
Croatian: Učestalost mogućih nuspojava navedenih u nastavku definirana je na sljedeći način: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Suboxone can also cause withdrawal symptoms if you stop taking it abruptly.
Croatian: Suboxone može također uzrokovati simptome ustezanja ako ga naglo prestanete uzimati.
English: • alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).
Croatian: • alkoholnim pićima ili lijekovima koji sadrže alkohol, jer alkohol pojačava sedativni učinak buprenorfina (vidjeti dio 4.7).
English: • asthma or other breathing problems
Croatian: • astmu ili bilo koji drugi problem s disanjem
English: Suboxone should not be taken together with:
Croatian: Suboxone ne bi trebalo uzimati zajedno s:
English: Some medicines may increase the side effects of Suboxone and may sometimes cause very serious reactions.
Croatian: Neki lijekovi mogu povećati nuspojave lijeka Suboxone te mogu ponekad uzrokovati vrlo ozbiljne reakcije.
English: Do not take Suboxone together with alcohol.
Croatian: Ne uzimajte Suboxone zajedno s alkoholom.
English: Patients with rare hereditary problems of galactose intolerance, should not take this medicine.
Croatian: Bolesnici s nasljednim problemima netolerancije galaktoze ne bi trebali uzimati ovaj lijek
English: However, Suboxone can be a target for people who abuse prescription medicine.
Croatian: Međutim, Suboxone može biti meta osobama koje zloupotrebljavaju lijekove koji se izdaju na recept.
English: • Misuse and abuse
Croatian: • Pogrešna uporaba i zlouporaba
English: Dublin 2
Croatian: Dublin 2 Irska
English: Naloxone has a mean half-life from plasma of 1.2 hours.
Croatian: Nalokson ima srednji poluvijek u plazmi od 1,2 sata.
English: Therefore, breastfeeding should be discontinued during treatment with Suboxone.
Croatian: Stoga dojenje treba prekinuti za vrijeme liječenja lijekom Suboxone.
English: o benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Croatian: o benzodiazepinima: Ova kombinacija može dovesti do smrti zbog središnje prouzročene depresije disanja.
English: • a urinary disorder (especially linked to enlarged prostrate in men)
Croatian: • poremećaj mokrenja (koji je osobito povezan s uvećanom prostatom u muškaraca)
English: Symptomatic treatment of respiratory depression, and standard intensive care measures, should be implemented.
Croatian: Treba provesti simptomatsko liječenje respiratorne depresije i standardne mjere intenzivne njege.
English: Like all medicines, Suboxone can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Suboxone može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the intervening days.
Croatian: Doza koja se daje ponedjeljkom i srijedom treba biti dvostruko viša od individualno titrirane dnevne doze, a doza petkom treba biti tri puta viša od individualno titrirane dnevne doze, bez uzimanja doze u međuvremenu.
English: What Suboxone looks like and contents of the pack
Croatian: Kako Suboxone izgleda i sadržaj pakiranja
English: Patients should be monitored following medical withdrawal because of the potential for relapse.
Croatian: Bolesnike treba nadzirati nakon ustezanja lijeka od strane liječnika zbog mogućnosti pojave relapsa.
English: Do not take any other medicines whilst taking Suboxone without first talking to your doctor, especially:
Croatian: Nemojte uzimati bilo koje druge lijekove dok uzimate Suboxone bez prethodnog razgovora sa svojim liječnikom, osobito:
English: (see section 4.3 and 5.2).
Croatian: (vidjeti dijelove 4.4. i 5.2).
English: Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Croatian: Buprenorfin/nalokson bi za vrijeme trudnoće trebalo koristiti isključivo ako potencijalna korist nadmašuje potencijalnu opasnost po fetus.
English: The maximum daily dose is 24 mg.
Croatian: Maksimalna dnevna doza je 24 mg.
English: Clear signs of withdrawal should be evident before taking your first dose of Suboxone.
Croatian: Jasni znakovi ustezanja trebali bi biti očiti prije uzimanja prve doze lijeka Suboxone.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek, jer sadrži Vama važne informacije.
English: Both Cmax and AUC of buprenorphine increased with the increase in dose (in the range of 4-16 mg), although the increase was less than dose-proportional.
Croatian: I Cmax i AUC buprenorfina povećali su se s povišenjem doze (u rasponu od 4-16 mg), iako povećanje nije bilo proporcionalno dozi, nego manje.
English: Depending on your condition, the dose of Suboxone may continue to be reduced under careful medical supervision, until eventually it may be stopped.
Croatian: Ovisno o Vašem stanju, sa snižavanjem doze lijeka Suboxone se može nastaviti pod pažljivim liječničkim nadzorom, sve do trenutka kad se eventualno može prekinuti.
English: Talk to your doctor before taking Suboxone if you have:
Croatian: Obratite se svom liječniku prije nego uzmete Suboxone ako imate:
English: Speech disorder Tremor
Croatian: Poremećaj govora Tremor
English: For any information about this medicine, please contact the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku, molimo obratite se nositelju odobrenja za stavljanje u promet gotovog lijeka:
English: Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4).
Croatian: Bolesnike se mora upozoriti da je iznimno opasno samoprimjenjivati nepropisane benzodiazepine tijekom uzimanja ovog lijeka, a također ih treba upozoriti da uzimaju benzodiazepine zajedno s ovim lijekom isključivo prema uputama njihovog liječnika (vidjeti dio 4.4).
English: If you forget to take Suboxone Tell your doctor as soon as possible if you miss a dose.
Croatian: Ako ste zaboravili uzeti Suboxone Obavijestite svog liječnika čim prije ako ste propustili dozu.
English: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Croatian: Nadomjesno liječenje ovisnosti o opioidimau okviru medicinskog, socijalnog i psihološkog liječenja.
English: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Croatian: Prijavljeni su smrtni slučajevi zbog depresije disanja, osobito kad se buprenorfin rabio u kombinaciji s benzodiazepinima (vidjeti dio 4.5), ili kad se buprenorfin nije rabio u skladu s propisanim uputama.
English: Following intravenous administration, naloxone is rapidly distributed (distribution halflife ~ 4 minutes).
Croatian: Nakon intravenske primjene, nalokson se brzo distribuira (poluvrijeme distribucije ~ 4 minute).
English: Tell your doctor if you have any liver problems before you start treatment with Suboxone.
Croatian: Obavijestite svog liječnika ako imate bilo kakvih problema s jetrom prije nego počnete liječenje lijekom Suboxone.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: U slučaju istovremenog PSUR-a i dopune RMP-a, možete ih podnijeti istovremeno.
English: Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes until a satisfactory response is achieved, but should not exceed a 10 mg starting dose.
Croatian: Početne doze naloksona mogu iznositi do 2 mg i mogu se ponavljati svakih 2-3 minute do postizanja zadovoljavajuće reakcije, s tim da početna doza ne bi smjela biti viša od 10 mg.
English: Urine Abnormality
Croatian: Abnormalnosti urina
English: • seeing or hearing things that are not there (hallucinations).
Croatian: • vidnih ili slušnih priviđanja (halucinacija).
English: Peak plasma concentrations are achieved 90 minutes after sublingual administration.
Croatian: Vršne koncentracije u plazmi postižu se 90 minuta nakon sublingvalne primjene.
English: A doctor's assessment of your readiness for treatment will guide the timing of your first Suboxone dose.
Croatian: Liječnička procjena Vaše spremnosti za liječenje odredit će vrijeme kada ćete uzeti prvu dozu lijeka Suboxone.
English: After a time of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Croatian: Nakon uspješnog liječenja, možete se složiti s Vašim liječnikom da se doza postupno snizi na nižu dozu održavanja.
English: The effectiveness of buprenorphine, 8 mg per day was similar to that of the moderate active control dose, but equivalence was not demonstrated.
Croatian: Učinkovitost buprenorfina u dozi od 8 mg/dan bila je slična onoj aktivne kontrole s umjerenom dozom, iako ekvivalencija nije dokazana.
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Croatian: Smrtni slučajevi također su prijavljeni vezano uz istovremenu primjenu buprenorfina i drugih depresora poput alkohola i drugih opioida.
English: If you stop taking Suboxone
Croatian: Ako prestanete uzimati Suboxone
English: • severe tiredness, itching with yellowing of skin or eyes.
Croatian: • jakog umora, svrbeža sa žutom bojom kože ili očiju.
English: Indivior Europe Limited Telephone 0808 234 9243
Croatian: Telefon: 0800 222 899
English: Animal studies have shown a reduction in female fertility at high doses (systemic exposure > 2.4 times the human exposure at the maximum recommended dose of 24 mg buprenorphine, based on AUC).
Croatian: Ispitivanja na životinjama pokazala su smanjenje plodnosti ženki pri izloženosti visokim dozama (sistemska izloženost > 2,4 puta od izloženosti ljudi pri maksimalnoj preporučenoj dozi od 24 mg buprenorfina, na temelju AUC).
English: When taken during pregnancy, particularly late pregnancy, medicines like Suboxone may cause drug withdrawal symptoms including problems with breathing in your newborn baby.
Croatian: Ako se uzimaju tijekom trudnoće, osobito u kasnom stadiju trudnoće, lijekovi poput lijeka Suboxone mogu uzrokovati sindrom ustezanja uključujući probleme s disanjem u Vašeg novorođenčeta.
English: Dosage adjustment and maintenance therapy:
Croatian: Prilagodba doze i terapija održavanja:
English: • Dependence This product can cause dependence.
Croatian: Ovaj lijek može uzrokovati ovisnost.
English: • Starting treatment of Suboxone whilst dependent on heroin
Croatian: • Početak liječenja lijekom Suboxone dok ste ovisni o heroinu
English: Opioids should be administered with caution to elderly or debilitated patients.
Croatian: Opioide je potrebno koristiti uz oprez u starijih i oslabljenih bolesnika.
English: Tell your doctor immediately or seek urgent medical attention if you experience side effects, such as:
Croatian: Odmah obavijestite svojeg liječnika ili potražite hitnu medicinsku pomoć ako primijetite nuspojave, kao što su:
English: Liver damage has been reported after taking Suboxone, especially when the medicine is misused.
Croatian: Zabilježeni su slučajevi oštećenja jetre nakon uzimanja lijeka Suboxone, osobito prilikom pogrešne uporabe lijeka.
English: Packed in packs of 7 and 28 tablets.
Croatian: Pakirane su po 7 i 28 tableta.
English: Towards the end of pregnancy buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration.
Croatian: Pred kraj trudnoće, buprenorfin može izazvati respiratornu depresiju u novorođenčeta, čak i nakon kratkog perioda primjene.
English: This product can cause withdrawal symptoms if you take it less than six hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone.
Croatian: Ovaj lijek može uzrokovati simptome ustezanja ako ga uzmete manje od šest sati otkad ste zadnji put uzeli kratkodjelujući opioid (npr. morfij, heroin) ili manje od 24 sata nakon što ste uzeli dugodjelujući opioid poput metadona.
English: For patients who may require a lower buprenorphine dose, buprenorphine 0.4 mg may be used.
Croatian: U bolesnika kojima treba niža doza buprenorfina, može se koristiti buprenorfin od 0,4 mg.
English: The risks of using Suboxone in pregnant women are not known.
Croatian: Rizici uzimanja lijeka Suboxone u trudnica nisu poznati.
English: However, the dose given on any one day should not exceed 24 mg buprenorphine.
Croatian: Međutim, sveukupna dnevna doza nikada ne smije biti viša od 24 mg buprenorfina.
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin).
Croatian: To su lijekovi koji se koriste za liječenje epilepsije (poput karbamazepina i fenitoina) i lijekovi koji se koriste za liječenje tuberkuloze (rifampicin).
English: Suboxone may cause drowsiness.
Croatian: Suboxone može izazvati omamljenost.
English: Table 1 summarises adverse reactions reported from pivotal clinical trials in which, 342 of 472 patients (72.5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.
Croatian: Tablica 1 sažima nuspojave zabilježene tijekom ključnih kliničkih ispitivanja u kojima su 342 od 472 bolesnika (72,5%) prijavila nuspojave i nuspojave zabilježene nakon stavljanja lijeka u promet.
English: Anxiety Depression Libido decreased Nervousness Thinking abnormal
Croatian: Anksioznost Depresija Smanjeni libido Nervoza Abnormalno razmišljanje
English: Dose titration in steps of 2-8 mg buprenorphine is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 24 mg buprenorphine.
Croatian: Doza se titrira u koracima od 2 do 8 mg buprenorfina u skladu s ponovnom procjenom kliničkog i psihološkog stanja bolesnika te ne smije premašiti maksimalnu pojedinačnu dnevnu dozu od 24 mg buprenorfina.
English: • feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you.
Croatian: • osjećaj pospanosti i nekoordiniranosti, zamagljen vid, nerazgovjetan govor, nemogućnost jasnog ili dobrog razumijevanja ili ako dišete mnogo sporije nego što je to uobičajeno.
English: • clonidine (used to treat high blood pressure) may extend the effects of this medicine.
Croatian: • klonidin (koristi se za liječenje visokog krvnog tlaka) može produljiti učinke ovog lijeka.
English: East Yorkshire HU8 7DS, United Kingdom.
Croatian: East Yorkshire HU8 7DS, Ujedinjeno Kraljevstvo.
English: Patients who are positive for viral hepatitis, on concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Croatian: U bolesnika koji su pozitivni na virusni hepatitis, istovremeno koriste druge lijekove (vidjeti dio 4.5) i/ili onih s postojećim poremećajem funkcije jetre postoji rizik od ubrzanog oštećenja jetre.
English: • if you are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion, or hallucinations caused by alcohol
Croatian: • ako ste intoksicirani zbog konzumacije alkohola ili imate drhtavicu, znojite se, tjeskobni ste, smeteni ili imate halucinacije uzrokovane alkoholom
English: Some risks of misuse and abuse include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury.
Croatian: Neki rizici pogrešne uporabe i zlouporabe lijeka uključuju predoziranje, širenje krvlju prenosivih virusnih ili lokaliziranih i sistemskih infekcija, depresiju disanja i oštećenje jetre.
English: Following treatment induction on day one, the patient should be stabilised to a maintenance dose during the next few days by progressively adjusting the dose according to the clinical effect of the individual patient.
Croatian: Nakon uvođenja terapije 1. dana, bolesnika treba stabilizirati na dozi održavanja tijekom sljedećih nekoliko dana, progresivnim prilagođavanjem doze sukladno kliničkom učinku u pojedinog bolesnika.
English: If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
Croatian: Ako se buprenorfin primjenjuje u osoba koje nisu ovisne o opioidima i nemaju toleranciju na učinke opioida, može doći do po život opasne depresije disanja.
English: These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines.
Croatian: Te vrste lijekova smanjuju Vašu razinu pažnje što Vam otežava upravljanje vozilima i strojevima.
English: Hull, East Yorkshire
Croatian: Dansom Lane Hull, East Yorkshire
English: The safety and efficacy of buprenorphine/naloxone in children below the age of 15 years have not been established.
Croatian: Sigurnost i djelotvornost buprenorfina/naloksona u djece mlađe od 15 godina nije ustanovljena.
English: Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms, so a continuing infusion may be necessary.
Croatian: Nalokson se može iščistiti brže od buprenorfina zbog čega bi se mogli vratiti prethodno kontrolirani simptomi predoziranja buprenorfinom, stoga bi kontinuirana infuzija mogla biti potrebna.
English: Buprenorphine/naloxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Croatian: Buprenorfin/nalokson može uzrokovati pospanost, osobito ako se uzme zajedno s alkoholom ili depresorima središnjeg živčanog sustava (kao što su sredstva za umirenje, sedativi ili hipnotici) (vidjeti dio 4.5).
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, povraćanje i/ili poremećaje govora.
English: They should not be taken at the same time as Suboxone treatment because you may experience a sudden onset of prolonged and intense withdrawal.
Croatian: Ne smiju se uzimati u isto vrijeme dok traje terapija lijekom Suboxone jer biste mogli osjetiti iznenadnu pojavu produljenih i intenzivnih simptoma ustezanja.
English: • Starting treatment of Suboxone whilst dependent on methadone
Croatian: • Početak liječenja lijekom Suboxone dok ste ovisni o metadonu
English: The availability of doses of 2 mg/0.5 mg and 8 mg/2 mg allows for a downward titration of dosage.
Croatian: Raspoloživost doza od 2 mg/0,5 mg i 8 mg/2 mg omogućava postupno snižavanje doze.
English: Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Croatian: Suboxone se koristi za liječenje ovisnosti o opioidima (narkoticima) kao što su heroin ili morfin kod ovisnika o drogama koji su pristali na liječenje ovisnosti.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the -opioid receptors which, over a prolonged period, might minimise the need of addicted patients for drugs.
Croatian: Njegova aktivnost u održavanju liječenja ovisnosti o opioidima pripisuje se njegovim sporim reverzibilnim svojstvima na µ-opioidne receptore koja, tijekom duljeg razdoblja, mogu minimalizirati potrebu ovisnika za lijekovima.
English: • Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain.
Croatian: • Druge lijekove koji Vas mogu učiniti pospanim, a koji se koriste za liječenje bolesti poput tjeskobe, nesanice, konvulzija/napadaja, boli.
English: Patients must be warned to store the blister safely, to never open the blister in advance, to keep them out of the reach of children and other household members, and not to take this medicine in front of children.
Croatian: Bolesnike je potrebno upozoriti da pakiranja čuvaju na sigurnom, da blister nikada ne otvaraju unaprijed, da ga čuvaju izvan dohvata djece i drugih članova kućanstva te da ne uzimaju lijek pred djecom.
English: Blood creatinine increased
Croatian: Povišene vrijednosi kreatinina u krvi
English: During the initiation of treatment, daily supervision of dosing is recommended to ensure proper sublingual placement of the dose and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.
Croatian: Tijekom početka liječenja, preporučuje se svakodnevno kontrolirati uzimanje lijeka kako bi se osiguralo pravilno sublingvalno postavljanje tablete/a i promatrati odgovor bolesnika na liječenje, kao pokazatelj učinkovitog titriranja doze sukladno kliničkom učinku.