FrancophonIA/ELRC3.0 huggingface dataset:
English: These effects can be worse if you drink alcohol or take other sedative medicines.
Croatian: Ti učinci se mogu pogoršati ako pijete alkohol ili uzimate druge sedative.
English: Rifampicin may decrease the effect of Buvidal.
Croatian: Rifampicin može smanjiti učinak Buvidala.
English: Push the needle all the way in.
Croatian: Iglu gurnite do kraja unutra.
English: These combinations increase central nervous system depression.
Croatian: Ove kombinacije povećavaju depresiju središnjeg živčanog sustava.
English: This is more likely at the start of treatment and when your dose is being changed.
Croatian: To je vjerojatnije na početku liječenja i kod promjene Vaše doze lijeka.
English: Buvidal has complete absolute bioavailability.
Croatian: Buvidal ima potpunu apsolutnu bioraspoloživost.
English: Nervousness Thinking abnormal Paranoia
Croatian: Abnormalno razmišljanje Paranoja
English: If you need a benzodiazepine, your doctor will prescribe the correct dose.
Croatian: Ako Vam je potreban benzodiazepin, Vaš liječnik će Vam propisati odgovarajuću dozu.
English: These may be symptoms of liver damage.
Croatian: Ovo mogu biti simptomi oštećenja jetre.
English: During your treatment, the doctor may adjust the dose, depending on how well the medicine works.
Croatian: Tijekom liječenja, Vaš liječnik može prilagođavati dozu, ovisno o tome koliko dobro djeluje lijek.
English: These medicines may also increase the risk of opioid overdose
Croatian: Ti lijekovi također mogu povećati rizik od predoziranja opioidima
English: Rechon Life Science AB Soldattorpsvägen 5 216 13 Limhamn Sweden
Croatian: Rechon Life Science AB Soldattorpsvägen 5 216 13 Limhamn Švedska
English: Overall, 156 patients (68.7%) completed the 48-week treatment period.
Croatian: Ukupno 156 bolesnika (68,7%) je završilo 48-tjedno razdoblje liječenja.
English: This may happen from several hours to several days after birth.
Croatian: Do toga može doći unutar nekoliko sati do nekoliko dana nakon rođenja.
English: There is no clinical data supporting reinjection of the monthly dose into the same site.
Croatian: Nema kliničkih podataka koji bi podržali ponovno injektiranje mjesečne doze u isto mjesto.
English: Assessment of long-term treatment is based on 48-week data.
Croatian: Procjena dugoročnog liječena temelji se na podacima prikupljenima tijekom 48 tjedana.
English: Buprenorphine should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Croatian: Buprenorfin se za vrijeme trudnoće smije koristiti samo ako potencijalna korist nadmašuje potencijalnu opasnost za fetus.
English: Not known (frequency cannot be estimated from the available data): - Hallucinations, feeling happiness and excitement (euphoria)
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - halucinacije, osjećaj sreće i uzbuđenja (euforija)
English: The syndrome is generally delayed from several hours to several days after birth.
Croatian: Sindrom se obično pojavljuje nekoliko sati do nekoliko dana nakon rođenja.
English: If you miss an appointment, ask your doctor when to schedule your next dose.
Croatian: Ako propustite termin, pitajte svojeg liječnika kada zakazati sljedeću dozu.
English: Your doctor may ask you to have regular blood tests to check your liver.
Croatian: Vaš liječnik može Vas zamoliti da redovito obavljate kontrolne pretrage za provjeru rada jetre.
English: During continued treatment with Buvidal, your doctor may decrease or increase your dose according to your need.
Croatian: Tijekom daljeg liječenja Buvidalom, Vaš liječnik može smanjivati ili povećavati dozu u skladu s Vašim potrebama.
English: Your doctor will prescribe the correct starting dose of Buvidal for you depending on the dose of sublingual buprenorphine you are now taking.
Croatian: Vaš liječnik propisat će Vam odgovarajuću početnu dozu Buvidala, ovisno o dozi sublingvalnog buprenorfina koju trenutno uzimate.
English: - rifampicin (used to treat tuberculosis).
Croatian: - rifampicin (koristi se za liječenje tuberkuloze).
English: Any used syringe should be discarded.
Croatian: Sve upotrijebljene štrcaljke treba baciti.
English: Do not touch the cleaned area again before injecting.
Croatian: Nemojte ponovno dodirivati očišćeno mjesto prije ubrizgavanja.
English: The recommended dose for the second treatment week is the total dose administered during the week of initiation.
Croatian: Preporučena doza za drugi tjedan liječenja je ukupna doza primijenjena tijekom tjedna uvođenja.
English: - Diagnosis of unrelated medical conditions: This medicine may mask pain and make it difficult to diagnose some diseases.
Croatian: - Dijagnoza nevezanih zdravstvenih stanja: Ovaj lijek može prekriti bol i otežati dijagnozu nekih bolesti.
English: Tell your doctor if you have any liver problems before you start treatment with Buvidal.
Croatian: Obavijestite svog liječnika ako imate bilo kakvih problema s jetrom prije nego počnete liječenje lijekom Buvidal.
English: - if you start to feel faint, as this may be a sign of low blood pressure.
Croatian: - ako osjetite da ćete se onesvijestiti, jer to može biti znak niskog krvnog tlaka.
English: If the patient vomits, precautions must be taken to prevent aspiration.
Croatian: Ako bolesnik povraća, treba primijeniti mjere za sprječavanje aspiracije.
English: Buvidal is not for use in children below 16 years of age.
Croatian: Buvidal nije namijenjen djeci mlađoj od 16 godina.
English: If a dose is missed, the next dose should be administered as soon as practically possible.
Croatian: Ako se doza propusti, sljedeću dozu treba dati što je prije praktično izvedivo.
English: • barbiturates (used to cause sleep or sedation)
Croatian: • barbiturati (koriste se za spavanje ili umirenje)
English: The first dose of Buvidal will be given to you when you show clear signs of withdrawal.
Croatian: Prva doza Buvidala dat će Vam se kada se pojave jasni znakovi ustezanja.
English: No interaction studies have been performed with Buvidal.
Croatian: Nisu provedena ispitivanja interakcija s Buvidalom.
English: Buvidal contains alcohol
Croatian: Buvidal sadrži alkohol
English: Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.
Croatian: Nemojte upravljati vozilima, koristiti se alatima ili strojevima, ili obavljati rizične aktivnosti dok ne znate kako ovaj lijek utječe na Vas.
English: These medicines may not work properly when taken together with Buvidal and they may increase the risk of overdose.
Croatian: Ti lijekovi možda neće pravilno djelovati kada se uzimaju zajedno s Buvidalom i mogu povećati rizik od predoziranja.
English: Monthly injection:
Croatian: Mjesečna injekcija:
English: It is especially important to tell your doctor if you are taking: - benzodiazepines (used to treat anxiety or sleep disorders).
Croatian: Pogotovo je važno da kažete svojem liječniku ako uzimate: - benzodiazepine (koriste se za liječenje tjeskobe ili poremećaja spavanja).
English: - Put on gloves and clean the injection site with a circular motion using an alcohol wipe (not provided in the pack).
Croatian: - Stavite rukavice i očistite mjesto ubrizgavanja kružnim pokretima koristeći alkoholni rupčić (nije priložen u pakiranju).
English: What Buvidal is and what it is used for
Croatian: Što je Buvidal i za što se koristi
English: The patient should be transferred to an environment within which full resuscitation facilities are available.
Croatian: Bolesnika treba premjestiti u uvjete gdje postoji kompletna oprema za oživljavanje.
English: - Blood pressure: This medicine may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.
Croatian: - Krvni tlak: Ovaj lijek može uzrokovati iznenadan pad Vašeg krvnog tlaka, uzrokujući osjećaj omaglice ako prebrzo ustajete iz sjedećeg ili ležećeg položaja.
English: The injection site reactions were all mild or moderate in severity and most events were transient.
Croatian: Sve reakcije na mjestu primjene injekcije bile su blagog ili umjerenog intenziteta i većina slučajeva bila je prolaznog karaktera.
English: The pharmacokinetic properties of Buvidal are described in section 5.2.
Croatian: Farmakokinetička svojstva Buvidala opisana su u dijelu 5.2.
English: Table 3 presents adverse reactions reported for buprenorphine, including Buvidal.
Croatian: Tablica 3 prikazuje nuspojave koje su prijavljene za buprenorfin, uključujući Buvidal.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe respiratory insufficiency
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 Teška respiratorna insuficijencija
English: The first dose of this medicine will be given to you at least 24 hours after you last used methadone.
Croatian: Prvu dozu ovog lijeka primit ćete najmanje 24 sta nakon zadnjeg uzimanja metadona.
English: Statistic Buvidal
Croatian: Statistika Buvidal
English: Symptomatic treatment of respiratory depression, following standard intensive care measures, should be instituted.
Croatian: Treba provesti simptomatsko liječenje depresije disanja u skladu sa standardnim mjerama intenzivne skrbi.
English: Administered dose should be as a single injection and not divided.
Croatian: Primijenjena doza mora se dati jednom injekcijom i ne dijeliti na više primjena.
English: Regular monitoring of the liver function is recommended.
Croatian: Preporučuje se redovito praćenje funkcije jetre.
English: Patients should be monitored during treatment.
Croatian: Bolesnike treba pratiti tijekom liječenja.
English: - gabapentinoids (gabapentin or pregabalin) (used to treat epilepsy or neuropathic pain).
Croatian: - gabapentinoide (gabapentin ili pregabalin) (koriste se za liječenje epilepsije ili neuropatske boli).
English: Other medicines and Buvidal
Croatian: Drugi lijekovi i Buvidal
English: Treatment of opioid dependence within a framework of medical, social and psychological treatment.
Croatian: Liječenje ovisnosti o opioidima u okviru medicinskog, socijalnog i psihološkog liječenja.
English: Patients attended 12 weekly visits during the first 12 weeks and 6 visits during the last 12 weeks (3 scheduled monthly visits and 3 random urine toxicology visits).
Croatian: Bolesnici su obavili 12 tjednih posjeta tijekom prvih 12 tjedana i 6 posjeta tijekom zadnjih 12 tjedana (3 zakazana mjesečna posjeta i 3 nasumična posjeta za toksikologiju urina).
English: Due to limited data in adolescents (aged 16 or 17 years), patients in this age group should be monitored closely during treatment.
Croatian: S obzirom na ograničene podatke u adolescenata (u dobi od 16 ili 17 godina), bolesnici ove dobne skupine trebaju se pažljivo pratiti tijekom liječenja
English: What Buvidal looks like and contents of the pack
Croatian: Kako Buvidal izgleda i sadržaj pakiranja
English: Tell your doctor immediately or get urgent medical attention if you have side effects such as:
Croatian: Odmah obavijestite svojeg liječnika ili potražite hitnu medicinsku pomoć ako imate nuspojave kao što su:
English: • alcoholic drinks or medicinal products 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: Elderly No pharmacokinetic data in elderly patients (> 65 years) are available.
Croatian: Starije osobe Nema dostupnih podataka o farmakokinetici u starijih bolesnika (>65 godina).
English: Weekly injection:
Croatian: Tjedna injekcija:
English: During continued treatment, you might receive one additional Buvidal 8 mg dose between your weekly or monthly treatments if your doctor thinks this is appropriate for you.
Croatian: U nastavku terapije, možda ćete primati jednu dodatnu dozu Buvidala od 8 mg između tjednih ili mjesečnih terapija, ukoliko Vaš liječnik smatra da je to za Vas prikladno.
English: In general, recommended dosing for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Croatian: Općenito, preporučeno doziranje za starije bolesnike s normalnom bubrežnom funkcijom je isto kao i za mlađe odrasle bolesnike s normalnom bubrežnom funkcijom.
English: Respiratory depression, as a result of central nervous system depression, is the primary symptom requiring intervention in the case of buprenorphine overdose because it may lead to respiratory arrest and death.
Croatian: Depresija disanja kao rezultat depresije središnjeg živčanog sustava je glavni simptom zbog kojeg je potrebna intervencija u slučaju predoziranja buprenorfinom, jer može dovesti do respiratornog aresta i smrti.
English: Do not refrigerate or freeze.
Croatian: Ne odlagati u hladnjak ili zamrzavati.
English: In rats there were no adverse effects on fertility of general reproductive function.
Croatian: U štakora nije bilo nuspojava vezanih uz plodnost, a koje bi utjecale na opću reproduktivnu funkciju.
English: - if you have serious breathing problems - if you have serious liver problems - if you are intoxicated with alcohol or have trembling, sweating, anxiety, confusion or hallucinations caused by alcohol
Croatian: - ako imate ozbiljne poteškoće s disanjem - ako imate ozbiljne poteškoće s jetrom - ako imate intoksikaciju alkoholom ili imate drhtavicu, znojenje, tjeskobu, smetenost ili halucinacije uzrokovane alkoholom
English: If you are already taking sublingual buprenorphine, you can start receiving Buvidal the day after your last treatment.
Croatian: Ako već uzimate sublingvalni buprenorfin, možete početi primati Buvidal sljedeći dan nakon zadnje terapije.
English: Some medicines may increase the side effects of Buvidal and may cause very serious reactions.
Croatian: Neki lijekovi mogu povećati nuspojave lijeka Buvidal i uzrokovati vrlo ozbiljne reakcije.
English: A long-term, open-label, phase 3 safety study with flexible dosing of weekly and monthly Buvidal for 48 weeks was conducted.
Croatian: Provedeno je dugoročno, otvoreno ispitivanje faze III s fleksibilnim doziranjem tjednog i mjesečnog Buvidala tijekom 48 tjedana.
English: General supportive measures should be instituted, including close monitoring of respiratory and cardiac status of the patient.
Croatian: Potrebno je primijeniti opće suportivne mjere, uključujući strogu kontrolu respiratornog i kardijalnog statusa bolesnika.
English: Buvidal can be administered weekly or monthly.
Croatian: Buvidal se može primjenjivati jednom tjedno ili jednom mjesečno.
English: Do not refrigerate or freeze
Croatian: Ne odlagati u hladnjak ili zamrzavati
English: Buvidal contains the active substance buprenorphine, which is a type of opioid medicine.
Croatian: Buvidal sadrži djelatnu tvar buprenorfin, koji je vrsta opioidnog lijeka.
English: When initiating treatment with buprenorphine, it is important to be aware of the partial agonist profile of buprenorphine.
Croatian: Pri započinjanju terapije buprenorfinom, treba biti svjestan parcijalnog agonističkog profila buprenorfina.
English: If used together with alcohol or central nervous system depressants, the effect is likely to be more pronounced (see sections 4.4. and 4.5).
Croatian: Ako se uzima zajedno s alkoholom ili depresorima središnjeg živčanog sustava, učinak će vjerojatno biti naglašeniji (vidjeti dijelove 4.4 i 4.5).
English: It can also occur because of viral infections (chronic hepatitis C), alcohol abuse, anorexia (eating disorder) or use of other medicines which harm your liver.
Croatian: To može biti uzrokovano i virusnim infekcijama (kroničnim hepatitisom C), zlouporabom alkohola, anoreksijom (poremećajem prehrane) ili primjenom drugih lijekova koji oštećuju Vašu jetru.
English: Care must be taken to avoid inadvertent injection of Buvidal.
Croatian: Treba izbjegavati nehotično ubrizgavanje Buvidala.
English: • opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine.
Croatian: • opioidni analgetici: Dostatnu analgeziju možda će biti teško postići kada se puni agonist opioida primjenjuje u bolesnika koji primaju buprenorfin.
English: No pharmacokinetic data in paediatrics (less than 18 years) are available.
Croatian: Nema dostupnih farmakokinetičkih podataka za pedijatrijsku populaciju (mlađi od 18 godina).
English: CDF = cumulative distribution function, CI = confidence interval, LS = least squares; SE = standard error, SL BPN/NX = sublingual buprenorphine/naloxone a Difference = Buvidal - SL BPN/NX.
Croatian: CDF = kumulativna funkcija distribucije, CI (confidence interval) = interval pouzdanosti, LS (least squares) = najmanji kvadrati; SE (standard error) = standardna greška, SL BPN/NX = sublingvalni buprenorfin/nalokson a Razlika = Buvidal - SL BPN/NX.
English: The following syringes are available:
Croatian: Dostupne su sljedeće štrcaljke:
English: Treatment is intended for use in adults and adolescents aged 16 years or over.
Croatian: Liječenje je namijenjeno za primjenu u odraslih i adolescenata u dobi od 16 godina ili više.
English: Acute toxicity of buprenorphine was determined in mice and rats following oral and parenteral (intravenous, intraperitoneal) administration.
Croatian: Akutna toksičnost buprenorfina utvrđena je u miševa i štakora nakon peroralne i parenteralne (intravenske, intraperitonealne) primjene.
English: Simulated buprenorphine exposure data in adolescents aged 16 years show lower Cmax and AUC compared to observed values in adults for weekly and monthly Buvidal.
Croatian: Simulirani podaci o izloženosti buprenorfinu u adolescenata u dobi od 16 godina pokazali su niže vrijednosti Cmax i AUC-a u usporedbi s uočenim vrijednostima u odraslih za tjednu i mjesečnu dozu
English: It is used to treat opioid dependence in patients who are also receiving medical, social and psychological support.
Croatian: Koristi se za liječenje ovisnosti o opioidima u bolesnika koji primaju zdravstvenu, socijalnu i psihološku potporu.
English: • clonidine (used to treat high blood pressure) - opioid painkillers.
Croatian: • klonidin (koristi se za liječenje visokog krvnog tlaka) - opioidne lijekove protiv bolova.
English: Taking alcohol with this medicine may increase drowsiness and may increase the risk of breathing problems.
Croatian: Uzimanje alkohola s ovim lijekom može pojačati pospanost i rizik od problema s disanjem.
English: The liquid should be clear.
Croatian: Tekućina treba biti bistra.
English: - Choose the injection site.
Croatian: - Izaberite mjesto ubrizgavanja.
English: Opioid-induced miosis, changes in the level of consciousness or changes in the perception of pain as a symptom of disease may interfere with patient evaluation or obscure the diagnosis or clinical course of concomitant disease.
Croatian: Mioza potaknuta opioidima, promjene u razini svijesti ili promjene u percepciji boli kao simptoma bolesti mogu utjecati na procjenu bolesnika ili otežati dijagnozu ili prikriti klinički tijek istodobno prisutne bolesti.
English: The patient should be cautioned not to drive or operate hazardous machinery whilst taking this medicine until it is known how the patient is affected by the medicine.
Croatian: Bolesnika treba upozoriti da ne vozi ili upravlja opasnim strojevima dok uzima lijek sve dok se ne sazna kako lijek utječe na bolesnika.
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 razdoblja primjene.
English: Depending on the findings, Buvidal may be discontinued.
Croatian: Ovisno o nalazima, davanje Buvidala se može prekinuti.
English: Of the 428 randomised patients, 69.0% (147/213) of the patients in the Buvidal treatment group and 72.6% (156/215) of the patients in the sublingual buprenorphine/naloxone treatment group completed the 24-week treatment period.
Croatian: Od 428 randomiziranih bolesnika, 69,0% (147/213) u skupini liječenoj Buvidalom i 72,6% (156/215) bolesnika u skupini liječenoj buprenorfinom/naloksonom, završilo je 24-tjedno razdoblje liječenja.
English: Figure 2 Before
Croatian: Slika 2 Prije
English: Total clearance of buprenorphine is approximately 68 L/h.
Croatian: Ukupni klirens buprenorfina je približno 68 l/h.
English: See section 6.6 for administration instructions.
Croatian: Za upute za primjenu vidjeti dio 6.6.
English: These medicines when taken together with Buvidal can slow down some brain activity and reduce alertness and how well you will drive and use machines.
Croatian: Kada se uzimaju zajedno s Buvidalom, ti lijekovi mogu usporiti određenu aktivnost mozga i smanjiti budnost i sposobnost upravljanja vozilima i strojevima.
English: Closer monitoring of patients is recommended during the dosing period after the switch.
Croatian: Preporuča se pomnije nadzirati bolesnike u razdoblju doziranja nakon prelaska.
English: Healthcare professionals should administer Buvidal directly to the patient.
Croatian: Zdravstveni radnici trebaju primijeniti Buvidal izravno bolesniku.
English: Patients who are positive for viral hepatitis, on certain concomitant medicinal products (see section 4.5) and/or who have existing liver dysfunction are at greater risk of liver injury.
Croatian: U bolesnika koji su pozitivni na virusni hepatitis, istodobno primaju druge lijekove (vidjeti dio 4.5) i/ili onih s postojećim poremećajem funkcije jetre postoji veći rizik od oštećenja jetre.
English: Examples of medicines that can make you feel sleepy or less alert include:
Croatian: Primjeri lijekova koji mogu uzrokovati pospanost ili smanjiti budnost:
English: Buprenorphine is extensively metabolised in the liver.
Croatian: Buprenorfin se opsežno metabolizira u jetri.
English: The decision to reinject at the same site should also be guided by the attending physicians´ clinical judgement.
Croatian: Odluka o ponovnom injektiranju u isto mjesto mora se donijeti uz kliničku procjenu nadležnog liječnika.
English: A minimum of 8 weeks should be left before reinjecting a previously used injection site with the weekly dose.
Croatian: Mora proći najmanje 8 tjedana prije ponovnog ubrizgavanja tjedne doze u prethodno korišteno mjesto ubrizgavanja.
English: Use in children and adolescents
Croatian: Primjena kod djece i adolescenata
English: • naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine.
Croatian: • naltrekson i nalmefen: Oni su antagonisti opioida koji mogu blokirati farmakološke učinke buprenorfina.
English: Also tell your doctor immediately if you get side effects such as: - severe tiredness, have no appetite or if your skin or eyes look yellow.
Croatian: Isto tako odmah recite liječniku ako dobijete nuspojave poput: - teškog umora, gubitka apetita ili ako Vam oči požute.
English: Opioids may elevate cerebrospinal fluid pressure, which may cause seizures.
Croatian: Opioidi mogu povećati tlak cerebrospinalne tekućine, što može uzrokovati napadaje.
English: The reduced level of alertness can make driving and using machinery hazardous (see section 4.7).
Croatian: Smanjena razina pažnje može povećavati rizik pri upravljanju vozilima i strojevima (vidjeti dio 4.7).
English: Do not re-use the safety syringe.
Croatian: Nemojte ponovno koristiti upotrijebljenu sigurnosnu štrcaljku.
English: The safety syringe includes a needle protection safety device that will activate at the end of the injection.
Croatian: Sigurnosna štrcaljka sadrži sigurnosni uređaj za zaštitu igle koji će se aktivirati na kraju ubrizgavanja.
English: Interaction with co-administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine.
Croatian: Interakcija s istodobno primjenjivanim induktorima ili inhibitorima utvrđena je u ispitivanjima u kojima se koristi transmukozni i transdermalni buprenorfin.
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala reproduktivnu toksičnost (vidjeti dio 5.3).