FrancophonIA/ELRC3.0 huggingface dataset:
English: For pharmacokinetic properties, see section 5.2 and for treatment termination, see section 4.2.
Croatian: Za farmakokinetička svojstva pogledajte dio 5.2, a za prekid liječenja dio 4.2.
English: To avoid missed doses, the weekly dose may be administered up to 2 days before or after the weekly time point, and the monthly dose may be administered up to 1 week before or after the monthly time point.
Croatian: Kako bi se izbjeglo propuštanje doza, tjedna doza može se primijeniti do 2 dana prije ili nakon predviđene tjedne vremenske točke primjene, a mjesečna doza se može primijeniti do 1 tjedan prije ili nakon predviđene mjesečne vremenske točke primjene.
English: Symptoms of overdose may include breathing more slowly and weakly than usual, feeling more sleepy than normal, smaller pupils.
Croatian: Simptomi prekomjerne doze mogu uključivati sporije i slabije disanje od uobičajenog, jači osjećaj pospanosti nego obično, sužene zjenice.
English: Preliminary symptoms of overdose may also include excessive sweating, somnolence, amblyopia, miosis, hypotension, nausea, vomiting and / or speech disorders.
Croatian: Preliminarni simptomi predoziranja također mogu uključivati prekomjerno znojenje, somnolenciju, ambliopiju, miozu, hipotenziju, mučninu, povraćanje i/ili poremećaje govora.
English: If you have received more buprenorphine than you should you need to contact your doctor immediately since this can cause very slow and shallow breathing which can lead to death.
Croatian: Ako ste primili više buprenorfina nego je potrebno, morate se odmah obratiti svojem liječniku, jer to može uzrokovati vrlo sporo i plitko disanje koje može završiti smrću.
English: • Must not be used if the safety syringe is broken or the packaging is damaged.
Croatian: • Ne smije se koristiti ako je sigurnosna štrcaljka slomljena ili je pakiranje oštećeno.
English: Your doctor will prescribe the correct dose for you.
Croatian: Liječnik će Vam propisati odgovarajuću dozu.
English: The study enrolled a total of 227 patients with moderate to severe opioid dependence, of which 190 patients were switched from sublingual buprenorphine (with or without naloxone), and 37 patients were new to buprenorphine treatment.
Croatian: U ispitivanje je bilo uključeno ukupno 227 bolesnika s umjerenom do teškom ovisnošću o opioidima, od čega je 190 bolesnika prešlo sa sublingvalnog buprenorfina (sa ili bez naloksona), a 37 bolesnika je prvi put liječeno buprenorfinom.
English: - Inspect the safety syringe closely:
Croatian: - Pažljivo pregledajte sigurnosnu štrcaljku:
English: • gabapentinoids: This combination may result in death due to respiratory depression.
Croatian: • gabapentinoidi: Ova kombinacija može dovesti do smrti zbog depresije disanja.
English: After
Croatian: Poslije
English: The risks of using Buvidal in pregnant women are not known.
Croatian: Rizici primjene lijeka Buvidal u trudnica nisu poznati.
English: Immediately dispose of the needle shield (never try to recap the needle).
Croatian: Odmah bacite zaštitni poklopac igle (nikad nemojte pokušavati vratiti poklopac na iglu).
English: Yellowish to yellow clear liquid.
Croatian: Žućkasta do žuta bistra tekućina.
English: Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines whilst 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 treba 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: • Dispose of the used safety syringe right away after use.
Croatian: • Bacite upotrijebljenu sigurnosnu štrcaljku neposredno nakon uporabe.
English: • UGT1A1 inhibitors may affect the systemic exposure of buprenorphine.
Croatian: • Inhibitori UGT1A1 mogu utjecati na sistemsko izlaganje buprenorfina.
English: Do not use this medicine if you notice visible particles or if it is cloudy.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive čestice ili ako je zamućen.
English: It is very important to keep all your appointments to receive Buvidal.
Croatian: Vrlo je važno doći na sve zakazane termine za primanje Buvidala.
English: In many cases, the presence of pre-existing liver enzyme abnormalities, genetic disease, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicinal products and ongoing injecting drug use may have a causative or contributory role.
Croatian: U mnogim slučajevima prisutnost postojećih abnormalnosti jetrenih enzima, genetskih bolesti, infekcije virusom hepatitisa B ili C, alkoholizma, anoreksije, uz istodobnu primjenu drugih potencijalno hepatotoksičnih lijekova i aktualna intravenska uporaba sredstava ovisnosti mogli su prouzročiti ove poremećaje ili im doprinijeti.
English: Titration of oral or intravenous short-acting opioid pain medicinal products (immediaterelease morphine, oxycodone or fentanyl) to the desired analgesic effect in patients treated with Buvidal might require higher doses.
Croatian: Titracija oralnog ili intravenskog kratkodjelujućeg opioidnog analgetika (morfina s trenutnim oslobađanjem, oksikodona ili fentanila) do željenog analgetskog učinka u bolesnika liječenih Buvidalom, može zahtijevati više doze.
English: • sedative antihistamines (used to treat allergic reactions)
Croatian: • sedativni antihistaminici (koriste se za liječenje alergijskih reakcija)
English: These underlying factors must be taken into consideration before prescribing buprenorphine and during treatment.
Croatian: Spomenuti čimbenici moraju se uzeti u obzir prije propisivanja buprenorfina, kao i tijekom samog liječenja.
English: If you are not already receiving sublingual (under the tongue) buprenorphine (the same active substance as in Buvidal), the recommended starting dose is 16 mg, with one or two additional Buvidal 8 mg doses given at least 1 day apart during the first treatment week.
Croatian: Ako već ne primate sublingvalni (ispod jezika) buprenorfin (ista djelatna tvar kao u Buvidalu), preporučena početna doza je 16 mg, s jednom ili dvije dodatne doze Buvidala od 8 mg dane s razmakom od najmanje 1 dana u prvom tjednu liječenja.
English: - Withdrawal symptoms: This medicine can cause withdrawal symptoms if you take it less than 6 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: - Simptomi ustezanja: Ovaj lijek može uzrokovati simptome ustezanja ako ga uzmete prije nego prođe 6 sati od zadnjeg uzimanja kratkodjelujućeg opioida (npr. morfin, heroin) ili 24 sata od zadnjeg uzimanja dugodjelujućeg opioida poput metadona.
English: If you are dependent on long-acting opioids (e.g. methadone), your dose of methadone will be reduced to below 30 mg per day before beginning with Buvidal.
Croatian: Ako ste ovisni o opioidima produljenog djelovanja (npr. metadon), Vaša doza metadona smanjit će se na manje od 30 mg dnevno prije početka terapije Buvidalom.
English: - Dispose of the used safety syringe right away after use.
Croatian: - Bacite upotrijebljenu sigurnosnu štrcaljku neposredno nakon uporabe.
English: Buprenorphine and its metabolites are excreted in human breast milk and Buvidal should be used with caution during breast-feeding.
Croatian: Buprenorfin i njegovi metaboliti izlučuju se u majčino mlijeko i Buvidal tijekom dojenja treba koristiti oprezno.
English: Recommended dose conversion when switching from weekly to monthly dosing or from monthly to weekly dosing
Croatian: Preporučena konverzija doze kod prelaska s tjednog na mjesečno doziranje ili s mjesečnog na tjedno doziranje
English: - Hold the safety syringe as shown and smoothly insert the needle at an angle of approximately
Croatian: - Držite sigurnosnu štrcaljku kako je prikazano i glatko uvedite iglu pod kutem od oko 90°
English: • Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4.
Croatian: • Buprenorfin se metabolizira u norbuprenorfin primarno pomoću CYP3A4.
English: It is recommended that the plunger is kept fully depressed while the needle is carefully lifted straight out from the injection site (see Figure 7).
Croatian: Preporuča se klip držati potisnutim do kraja dok se igla pažljivo ravno izvlači iz mjesta ubrizgavanja (vidjeti Sliku 7).
English: Undesirable effects were based on the known pharmacological activity of buprenorphine.
Croatian: Nuspojave su se temeljile na poznatoj farmakološkoj aktivnosti burpenorfina.
English: When switching from sublingual buprenorphine to Buvidal, patients may need to be monitored to ensure plasma buprenorphine levels are adequate.
Croatian: Kod prelaska sa sublingvalnog buprenorfina na Buvidal, bolesnike može biti potrebno pratiti kako bi se osiguralo da su razine buprenorfina u plazmi odgovarajuće.
English: Norbuprenorphine is a µ-opioid agonist with weak intrinsic activity.
Croatian: Norbuprenorfin je μ-opioidni agonist sa slabom intrinzičkom aktivnošću.
English: Conventional sublingual buprenorphine daily treatment doses and recommended corresponding doses of weekly and monthly Buvidal Dose of daily sublingual buprenorphine
Croatian: Konvencionalne dnevne terapijske doze sublingvalnog buprenorfina i preporučene odgovarajuće tjedne i mjesečne doze Buvidala Dnevna doza sublingvalnog buprenorfina
English: The efficacy and safety of buprenorphine in elderly patients > 65 years have not been established.
Croatian: Sigurnost i djelotvornost buprenorfina u bolesnika starijih od 65 godina nisu ustanovljene.
English: Buprenorphine may cause drowsiness, dizziness or impaired thinking, especially during treatment induction and dose adjustment.
Croatian: Buprenorfin može izazvati omamljenost, omaglicu ili umanjiti sposobnost razmišljanja, osobito tijekom početka liječenja i prilagodbe doze.
English: • antipsychotics (used to treat psychiatric disorders such as schizophrenia)
Croatian: • antipsihotici (koriste se za liječenje psihijatrijskih poremećaja poput shizofrenije)
English: • benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Croatian: • benzodiazepinima: Ova kombinacija može dovesti do smrti zbog depresije disanja središnjeg podrijetla.
English: The dose of buprenorphine in mg can differ between sublingual products, which needs to be taken into consideration on a product-by-product basis.
Croatian: Doza buprenorfina izražena u mg može se razlikovati od jednog do drugog sublingvalnog lijeka, što treba uzeti u obzir kod svakog proizvoda.
English: If you have any further questions on the use of this product, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku.
English: - While holding the safety syringe by the syringe guard body as shown (see Figure 4), carefully pull the needle shield straight off.
Croatian: - Držeći sigurnosnu štrcaljku za štitnik prema prikazu (vidjeti Sliku 4), pažljivo ravno povucite zaštitni poklopac igle.
English: Doses may be increased or decreased and patients can be switched between weekly and monthly products according to individual patient's needs and treating physician's clinical judgement as per recommendations in Table 2.
Croatian: Doze se mogu povećavati ili smanjivati, a bolesnici mogu prelaziti s tjednih na mjesečne primjene lijeka i obrnuto u skladu s osobnim potrebama i kliničkoj prosudbi ordinirajućeg liječnika, prema preporukama iz Tablice
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za primjenu za zdravstvene radnike
English: - Liver damage: Liver damage can occur with buprenorphine, especially when it is misused.
Croatian: - Oštećenje jetre: Može doći do oštećenja jetre kod uzimanja buprenorfina, pogotovo kada se zlorabi.
English: Intravascular such as intravenous injection would present a risk of serious harm as Buvidal forms a solid mass upon contact with body fluids, which potentially could cause blood vessel injury, occlusion, or thromboembolic events.
Croatian: Ubrizgavanje lijeka u krvnu žilu, poput intravenske injekcije, može predstavljati rizik od ozbiljnog oštećenja, jer Buvidal u kontaktu s tjelesnim tekućinama tvori krutu masu, koja bi mogla uzrokovati ozljedu krvnih žila, začepljenje ili tromboembolijske događaje.
English: If you are dependent on short-acting opioids (e.g. morphine or heroin), the first dose of Buvidal will be given to you at least 6 hours after you last used an opioid.
Croatian: Ako ste ovisni o opioidima kratkog djelovanja (npr. morfinu ili heroinu), prvu dozu Buvidala ćete primiti najmanje 6 sati nakon zadnjeg uzimanja opioida.
English: Ethanol anhydrous
Croatian: Etanol dehidrirani
English: Procedural dizziness
Croatian: Proceduralna vrtoglavica
English: Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms.
Croatian: Eliminacija naloksona može biti brža od eliminacije buprenorfina, omogućujući vraćanje prethodno kontroliranih simptoma predoziranja buprenorfinom.
English: Opioids may cause orthostatic hypotension.
Croatian: Opioidi mogu uzrokovati ortostatsku hipotenziju.
English: A patent airway and assisted or controlled ventilation must be assured.
Croatian: Mora se osigurati prohodnost dišnih puteva te asistirana ili kontrolirana ventilacija.
English: Buvidal with alcohol
Croatian: Buvidal s alkoholom
English: • Intravascular, intramuscular and intradermal administration must be avoided.
Croatian: • Mora se izbjegavati intravaskularna, intramuskularna i intradermalna primjena.
English: Modification of the buprenorphine dose is not required for patients with renal impairment.
Croatian: Promjena doze buprenorfina nije potrebna u bolesnika s oštećenjem bubrega.
English: Teratology and reproduction toxicity studies in rats and rabbits by intramuscular administration concluded that buprenorphine is not embryotoxic or teratogenic and has no marked effects on weaning potential.
Croatian: U ispitivanjima teratogenih učinaka i reproduktivne toksičnosti u štakora i kunića kod intramuskularne primjene, zaključeno je da buprenorfin nije embriotoksičan ni teratogen i da nema značajnih učinaka na potencijal odbijanja mladunčadi od sisanja.
English: If you stop using Buvidal
Croatian: Ako prestanete primjenjivati Buvidal
English: Therefore, opioids should be used with caution in patients with head injury, intracranial lesions, other circumstances where cerebrospinal pressure may be increased, or history of seizure.
Croatian: Stoga je opioide potrebno koristiti uz oprez u bolesnika s ozljedom glave, intrakranijalnim lezijama i drugim okolnostima u kojima bi cerebrospinalni tlak mogao biti povišen ili u bolesnika s napadajima u anamnezi.
English: Buvidal must be given by healthcare professionals only.
Croatian: Buvidal smiju davati samo zdravstveni radnici.
English: Termination of treatment
Croatian: Prekid liječenja
English: CDF of percentage of urine samples negative for illicit opioids over weeks 4-24
Croatian: CDF postotka uzoraka urina koji su negativni na nedopuštene opioide od 4. - 24. tjedna
English: Injections on the waistline or within 5 cm of the navel should be avoided.
Croatian: Treba izbjegavati ubrizgavanje u području struka ili u području unutar 5 cm oko pupka.
English: The long duration of action of buprenorphine and the prolonged release from Buvidal, should be taken into consideration when determining length of treatment needed to reverse the effects of an overdose, (see section 4.4).
Croatian: Dugo djelovanje buprenorfina i produljeno oslobađanje iz Buvidala, treba uzeti u obzir pri određivanju trajanja terapije potrebne za uklanjanje učinaka predoziranja, (vidjeti dio 4.4).
English: Due to the long half-life of buprenorphine, neonatal monitoring for several days after birth should be considered to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Croatian: Zbog dugog poluvijeka buprenorfina, potrebno je razmotriti praćenje novorođenčeta tijekom prvih nekoliko dana života, a radi sprječavanja rizika od depresije disanja ili sindroma ustezanja u novorođenčeta.
English: If you miss a dose of Buvidal
Croatian: Ako propustite dozu Buvidala
English: Using this medicine during late pregnancy may cause drug withdrawal symptoms including breathing problems in your new-born baby.
Croatian: Ako se ovaj lijek koristi u kasnom stadiju trudnoće, može uzrokovati simptome ustezanja uključujući probleme s disanjem u Vašeg novorođenčeta.
English: Injection sites should be rotated for both weekly and monthly injections.
Croatian: Mjesta za ubrizgavanje treba mijenjati i kod tjednih i kod mjesečnih injekcija.
English: - Pinch the skin at the injection site between the thumb and finger as shown (see Figure 5).
Croatian: Slika 4: - Kožu na mjestu ubrizgavanja uhvatite između palca i prsta kako je prikazano (vidjeti Sliku 5).
English: If you have not used buprenorphine before you will receive a 4 mg sublingual buprenorphine dose and be observed for an hour before the first Buvidal dose.
Croatian: Ako prethodno niste koristili buprenorfin, primit ćete sublingvalnu dozu buprenorfina od 4 mg i biti na promatranju jedan sat prije prve doze Buvidala.
English: • For patients receiving methadone, the methadone dose should be reduced to a maximum of 30 mg/day before starting treatment with Buvidal which should not be administered until at least 24 hours after the patient last received a methadone dose.
Croatian: • Za bolesnike koji uzimaju metadon, dozu metadona treba smanjiti na najviše 30 mg/dan prije početka terapije Buvidalom, koji se ne smije davati dok nije proteklo najmanje 24 sata nakon što je bolesnik primio zadnju dozu metadona.
English: Once uncapped, never try to recap the needle.
Croatian: Nakon skidanja poklopca nikad nemojte pokušavati vratiti poklopac na iglu.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the μ-opioid receptors which, over a prolonged period, might minimise the need of illicit opioids for patients with opioid dependence.
Croatian: Njegova aktivnost u održavanju liječenja ovisnosti o opioidima pripisuje se njegovom svojstvu sporo reverzibilnog vezanja na μ-opiodne receptore koje bi, tijekom duljeg razdoblja, moglo minimalizirati potrebu ovisnika za nedopuštenim opioidima.
English: Taking too much of a benzodiazepine together with Buvidal may lead to death because both medicines can cause very slow and shallow breathing (respiratory depression).
Croatian: Uzimanje prevelike količine benzodiazepina zajedno s Buvidalom može uzrokovati smrt jer oba lijeka mogu uzrokovati vrlo sporo i plitko disanje (respiratornu depresiju).
English: If treatment is continued, hepatic function should be monitored closely.
Croatian: Ako se nastavi s liječenjem, treba pomno pratiti funkciju jetre.
English: Percentage of urine samples negative for illicit opioids
Croatian: Postotak uzoraka urina koji su negativni na nedopuštene opioide
English: Continuing treatment and dose adjustment
Croatian: Dalje liječenje i prilagodba doze
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in opioid dependence, ATC code: N07BC01
Croatian: Farmakoterapijska skupina: Ostali lijekovi koji djeluju na središnji živčani sustav, lijekovi za liječenje ovisnosti o opioidima, ATK oznaka: N07BC01
English: • antidepressants (used to treat depression)
Croatian: • antidepresivi (koriste se za liječenje depresije)
English: After injection, the buprenorphine plasma concentration increases with a median time to maximum plasma concentration (tmax) of about 24 hours.
Croatian: Nakon injekcije se koncentracija buprenorfina u plazmi povećava, a medijan vremena do postizanja maksimalne koncentracije u plazmi (tmax) iznosi oko 24 sata.
English: - sudden wheezing, difficulty breathing, swelling of the eyelids, face, tongue, lips, throat or hands; rash or itching especially over your whole body.
Croatian: - iznenadno piskanje u plućima, otežano disanje, oticanje očnih kapaka, lica, jezika, usana, grla ili šaka; osip ili svrbež, pogotovo ako zahvaća cijelo tijelo.
English: Injections should be rotated between sites in the buttock, thigh, abdomen, or upper arm (see Figure 3) with a minimum of 8 weeks before re-injecting a previously used injection site.
Croatian: Mjesto ubrizgavanja treba izmjenjivati između stražnjice, bedra, trbuha ili nadlaktice (vidjeti Sliku 3), pri čemu treba proći najmanje 8 tjedana prije ponovnog ubrizgavanja u prethodno korišteno mjesto ubrizgavanja.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ (mu) and κ (kappa) opioid receptors of the brain.
Croatian: Buprenorfin je parcijalni agonist/antagonist opioida koji se veže za µ (mi) i κ (kapa) opioidne receptore u mozgu.
English: The effects on buprenorphine exposure in patients treated with Buvidal have not been studied.
Croatian: Učinci izlaganja buprenorfinu u bolesnika liječenih Buvidalom nisu ispitani.
English: The needle protection will help to prevent needle stick injuries.
Croatian: Štitnik igle će pomoći spriječiti ozljede uzrokovane ubodom igle.
English: Caution should be exercised when co-administering Buvidal with other medicinal products that prolong the QT interval and in patients with a history of long QT syndrome or other risk factors for QT prolongation.
Croatian: Treba postupati oprezno kod paralelne primjene Buvidala s ostalim lijekovima koji produljuju QT interval i u bolesnika s anamnezom sindroma dugog QT intervala ili drugih čimbenika rizika za produljenje QT intervala.
English: However, because elderly patients may have diminished renal/hepatic function, dose adjustment may be necessary (see Hepatic impairment and Renal impairment below).
Croatian: Međutim, kako je kod starijih bolesnika moguća smanjena bubrežna/jetrena funkcija, može biti potrebna prilagodba doze (vidjeti u nastavku Oštećenje funkcije jetre i Oštećenje funkcije bubrega).
English: The prolonged-release properties of the product should be considered during treatment including initiation and termination.
Croatian: Svojstva produljenog otpuštanja lijeka treba uzeti u obzir tijekom liječenja, uključujući uvođenje i prekid uzimanja lijeka.
English: Buvidal is intended for use in adults and adolescents aged 16 years or over.
Croatian: Buvidal je namijenjen za primjenu u odraslih i adolescenata u dobi od 16 godina ili više.
English: - if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primati Buvidal: - ako ste alergični nabuprenorfin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Please note that the smallest injection volume is barely visible in the viewing window as the spring of the safety device is “covering” part of the glass cylinder close to the needle.
Croatian: Napomena: Najmanji volumen ubrizgavanja je jedva vidljiv u kontrolnom prozorčiću jer opruga sigurnosnog uređaja "prekriva" dio staklenog cilindra pokraj igle.
English: Important things to be aware of - Breathing problems: Some people have died from very slow or shallow breathing caused by taking buprenorphine with other central nervous system depressants (substances that slow down some brain activity) such as benzodiazepines, alcohol or other opioids.
Croatian: Važne stvari o kojima treba voditi računa - Problemi s disanjem: Ima ljudi koji su umrli zbog vrlo sporog ili plitkog disanja uzrokovanog uzimanjem buprenorfina s drugim supresorima središnjeg živčanog sustava (tvarima koje usporavaju određenu aktivnost mozga), poput benzodiazepina, alkohola ili drugih opioida.
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol, gabapentinoids (such as pregabalin and gabapentin) (see section 4.5) or other opioids.
Croatian: Smrtni slučajevi također su prijavljeni vezano uz istodobnu primjenu buprenorfina i drugih depresora poput alkohola, gabapentinoida (poput pregabalina i gabapentina) (vidjeti dio 4.5) ili drugih opioida.