FrancophonIA/ELRC3.0 huggingface dataset:
English: Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see section 2, Warnings and precautions).
Croatian: Pogrešna primjena ovog lijeka putem ubrizgavanja može uzrokovati simptome ustezanja, infekcije, druge kožne reakcije i potencijalno ozbiljne probleme s jetrom (vidjeti dio 2, „Upozorenja i mjere opreza”).
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-opioid dependent people.
Croatian: Ovaj lijek može uzrokovati tešku, moguće i sa smrtnim ishodom, respiratornu depresiju (smanjena sposobnost disanja) u djece i osoba koje nisu ovisne.
English: Sublingual tablet
Croatian: Sublingvalna tableta
English: This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines that can harm your liver.
Croatian: To može biti uzrokovano i virusnim infekcijama (kroničnim hepatitisom C), zlouporabom alkohola, anoreksijom ili primjenom drugih lijekova koji mogu biti štetni za jetru.
English: Clinical data confirm that CYP3A4 is responsible for the N-dealkylation of buprenorphine.
Croatian: Klinički podaci potvrđuju da je CYP3A4 odgovoran za N-dealkilaciju buprenorfina.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6. Plodnost, trudnoća i dojenje Trudnoća
English: • Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain and other mental disorders.
Croatian: • Druge lijekove koji Vas mogu učiniti pospanim, a koji se koriste za liječenje bolesti poput tjeskobe, nesanice, konvulzija/napadaja, boli ili drugih psihičkih poremećaja.
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Croatian: Farmakoterapijska skupina: ostali lijekovi s djelovanjem na živčani sustav, lijekovi za liječenje ovisnosti, ATK oznaka: N07BC51.
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: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake EXP.
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: Your doctor will decide if your treatment should be continued with an alternative medicine.
Croatian: Liječnik će odlučiti hoćete li nastaviti liječenje nekim drugim lijekom.
English: • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash.
Croatian: • oticanje lica, usnica, jezika ili ždrijela što može uzrokovati otežano gutanje ili disanje, jaku koprivnjaču/osip.
English: The combination of buprenorphine and naloxone has been investigated in acute and repeated dose (up to 90 days in rats) toxicity studies in animals.
Croatian: Kombinacija buprenorfina i naloksona ispitivana je u ispitivanjima akutne i toksičnosti ponovljenih doza u životinja (do 90 dana u štakora).
English: If infusion is not possible, repeated dosing with naloxone may be required.
Croatian: Ako infuzija nije moguća, možda će biti potrebno ponovljeno doziranje naloksonom.
English: Other medicines and Zubsolv
Croatian: Drugi lijekovi i Zubsolv
English: Injury
Croatian: Ozljede
English: If taken 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: 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 ili drugih opioida.
English: Zubsolv sublingual tablets are available in six different strengths, differentiated by shape and debossing:
Croatian: Zubsolv sublingvalne tablete dostupne su u šest različitih jačina te imaju različite oblike i utisnute oznake:
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 17.2 mg buprenorphine, based on AUC) (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su smanjenje plodnosti ženki pri visokim dozama (sistemska izloženost >2,4 puta od izloženosti ljudi pri maksimalnoj preporučenoj dozi od 17,2 mg buprenorfina, na temelju AUC vrijednosti) (vidjeti dio 5.3).
English: Sublingual use.
Croatian: Sublingvalna primjena.
English: If you stop taking Zubsolv
Croatian: Ako prestanete uzimati Zubsolv
English: Hepatitis and hepatic events
Croatian: Hepatitis i jetreni događaji
English: Therefore the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining
Croatian: Stoga postoji mogućnost predoziranja punim agonistom, naročito kad se pokušavaju poništiti učinci parcijalnog agonista buprenorfina ili kad su razine buprenorfina u plazmi u opadanju.
English: Furthermore, the use of buprenorphine/naloxone during pregnancy should be assessed by the physician.
Croatian: Nadalje, uporabu buprenorfina/naloksona tijekom trudnoće trebao bi odobriti liječnik.
English: Erectile dysfunction
Croatian: Erektilna disfunkcija
English: Fold the packet along the dotted line.
Croatian: Presavijte karticu uzduž točkaste crte.
English: • Full opioid agonist: adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine/naloxone.
Croatian: • Puni agonist opioida: dostatnu analgeziju možda će biti teško postići kada se puni agonist opioida primjenjuje u bolesnika koji primaju buprenorfin/nalokson.
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 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: • menstrual or vaginal problems, abnormal ejaculation
Croatian: • menstrualni ili vaginalni problemi, poremećaji ejakulacije
English: Zubsolv should not be taken together with:
Croatian: Zubsolv ne bi trebalo uzimati zajedno s:
English: Your doctor may increase the dose of Zubsolv you take according to your needs.
Croatian: Liječnik Vam može povisiti dozu lijeka Zubsolv prema Vašim potrebama.
English: Zubsolv may cause drowsiness.
Croatian: Zubsolv može izazvati omamljenost.
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 daje osobama koje su ovisne o neopijatnim lijekovima i ne podnose učinke opijata, može doći do potencijalno smrtonosne depresije disanja.
English: Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Croatian: Zbog dugog poluvijeka buprenorfina, na kraju trudnoće trebala bi se razmotriti mogućnost praćenja neonatalnog razvoja kroz nekoliko dana, a radi sprječavanja rizika od depresije disanja ili sindroma ustezanja u novorođenčeta.
English: - are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6)
Croatian: - ako ste alergični na buprenorfin, nalokson ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Once the appropriate dose has been identified for a patient with a specific buprenorphine product, that product should not be exchanged with another product.
Croatian: Jednom kada se utvrdi odgovarajuća doza specifičnog lijeka koji sadrži buprenorfin za bolesnika taj lijek se ne smije mijenjati drugim.
English: The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both buprenorphine/naloxone versus placebo (p < 0.0001) and buprenorphine versus placebo (p < 0.0001).
Croatian: Postotak uzoraka urina uzorkovanih tri puta tjedno koji su bili negativni na opioide izvan ispitivanja, bio je statistički veći za buprenorfin/nalokson u usporedbi s placebom (p < 0,0001), i za buprenorfin u usporedbi s placebom (p < 0,0001).
English: Angina Pectoris Bradycardia Myocardial infarction Palpitations Tachycardia
Croatian: Angina pectoris Bradikardija Infarkt miokarda Palpitacije Tahikardija
English: There are small deviations in buprenorphine dose proportionality exposure parameters as well as deviations from strict compositional proportionality for the three lower strengths (2.9/0.71, 1.4/0.36, and 0.7/0.18 mg) compared to the three higher dose presentations.
Croatian: Postoje mala odstupanja kod parametara izloženosti proporcionalnosti doze buprenorfina kao i odstupanja od stroge proporcionalnosti sastava za tri najniže jačine (2,9/0,71, 1,4/0,36 i 0,7/0,18 mg) u usporedbi s tri najviše doze.
English: The dose in mg can differ between buprenorphine products and products are not directly interchangeable.
Croatian: Doza u mg može se razlikovati između lijekova koji sadrže buprenorfin, a lijekovi nisu izravno međusobno zamjenjivi.
English: Zubsolv must not be taken together with:
Croatian: Zubsolv ne smije se uzimati zajedno s:
English: This medicine may mask pain symptoms that could assist in the diagnosis of some diseases.
Croatian: Ovaj lijek može zamaskirati bol koja ukazuje na neke bolesti.
English: All strengths will be available as packs of 7, 28, and 30 tablets presented in aluminium blisters.
Croatian: Sve jačine dostupne su u pakiranju od 7, 28 i 30 tableta upakiranih u aluminijske blistere.
English: Naloxone can be eliminated 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 eliminirati brže od buprenorfina zbog čega bi se mogli vratiti prethodno kontrolirani simptomi predoziranja buprenorfinom, stoga bi kontinuirana infuzija mogla biti potrebna.
English: • increased tearing (watering eyes) or other tearing disorder
Croatian: • pojačano suzenje (suzenje očiju) ili drugi poremećaji suzenja
English: For steps of 1.4-5.7 mg buprenorphine this titration is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 17.2 mg buprenorphine (e.g. given as 11.4 + 5.7 mg, 2 x 8.6 mg or 3 x 5.7 mg).
Croatian: Za korake od 1,4 do 5,7 mg buprenorfina, ova titracija se provodi u skladu s ponovnom procjenom kliničkog i psihološkog stanja bolesnika te ne smije premašiti maksimalnu pojedinačnu dnevnu dozu od 17,2 mg buprenorfina (primjerice doza od 11,4 + 5,7 mg, 2 x 8,6 mg ili 3 x 5,7 mg).
English: After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Croatian: Nakon postizanja zadovoljavajuće stabilizacije, uz suglasnost bolesnika, doza se može postupno snižavati na nižu dozu održavanja; u nekim povoljnim slučajevima liječenje se može i prekinuti.
English: Ongoing intravenous infusion rates should be titrated to patient response.
Croatian: Daljnju stopu intravenske infuzije trebalo bi titrirati prema reakciji bolesnika.
English: • low blood pressure
Croatian: • nizak krvni tlak
English: • acne, hair loss, dry or scaling skin, skin nodule
Croatian: • akne, gubitak kose, suha ili perutava koža, kožni čvorići
English: Bronchospasm Respiratory depression
Croatian: Bronhospazam Depresija disanja
English: Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicinal product is not safeguarded against theft.
Croatian: Zlouporaba buprenorfina od strane nekog drugog osim bolesnika kojem je buprenorfin namijenjen, predstavlja dodatni rizik pojave novih ovisnika koji koriste buprenorfin kao primarno sredstvo ovisnosti, a ovisnost se može pojaviti i ako bolesnik izravno distribuira lijek za zabranjenu primjenu ili ako se lijek ne zaštiti od krađe.
English: Physicians are encouraged to prescribe a single tablet once daily regimen where possible to minimise risk of diversion.
Croatian: Liječnicima se preporučuje propisivanje režima jedne tablete jednom dnevno, ako je moguće, kako bi se smanjio rizik od uporabe lijeka u svrhe za koje nije namijenjen.
English: The combination (4:1) of buprenorphine hydrochloride and naloxone hydrochloride was not mutagenic in a bacterial mutation assay (Ames test), and was not clastogenic in an in vitro cytogenetic assay in human lymphocytes or in an intravenous micronucleus test in the rat.
Croatian: Kombinacija (4:1) buprenorfin hidroklorida i nalokson hidroklorida nije imala mutagene učinke u ispitivanju mutagenosti na bakterijama (Amesov test) i nije bila klastogenična u citogenetičkom ispitivanju in vitro na ljudskim limfocitima ili u intravenskom mikronukleusnom testu u štakora.
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 pratiti doziranje kako bi se osiguralo pravilno sublingvalno postavljanje doze i promatrati odgovor bolesnika na liječenje, kao pokazatelj učinkovitog titriranja doze sukladno kliničkom učinku.
English: Depression Libido decreased Nervousness Thinking abnormal
Croatian: Anksioznost Depresija Smanjeni libido Nervoza Abnormalno razmišljanje
English: When taken during pregnancy, particularly late pregnancy, medicines like Zubsolv 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 Zubsolv mogu uzrokovati sindrom ustezanja uključujući probleme s disanjem u Vašeg novorođenčeta.
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 on the individual patient.
Croatian: Nakon uvođenja terapije prvog dana, bolesnika je potrebno stabilizirati na dozi održavanja tijekom sljedećih nekoliko dana, progresivnim prilagođavanjem doze sukladno kliničkom učinku u pojedinog bolesnika.
English: Naloxone is an antagonist at μ-opioid receptors.
Croatian: Nalokson je antagonist μ-opioidnih receptora.
English: Use of an opioid antagonist (i.e., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.
Croatian: Preporučuje se uporaba antagonista opioida (tj. naloksona), usprkos umjerenom učinku koji taj antagonist može imati u otklanjanju respiratornih simptoma buprenorfina, u usporedbi s njegovim učincima na pune agoniste opioida.
English: Blood creatinine increased
Croatian: Povišene vrijednosti kreatinina u krvi
English: In cases of intravenous drug misuse, some adverse reactions are attributed to the act of misuse rather than the medicinal product.
Croatian: U slučajevima pogrešne intravenske uporabe lijeka, neke nuspojave su prije povezane s činom pogrešne uporabe, nego s lijekom.
English: Opioids may elevate cerebrospinal fluid pressure, which may cause seizures, so 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: Opioidi mogu povisiti tlak cerebrospinalne tekućine što može uzrokovati napadaje, 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: • amnesia (memory disturbance), convulsion (fits), speech disorder, tremor
Croatian: • amnezija (poremećaj pamćenja), konvulzije (napadaji), poremećaji govora, nevoljno drhtanje
English: If the patient vomits, care must be taken to prevent aspiration of the vomitus.
Croatian: Ako bolesnik povraća, mora se spriječiti aspiracija povraćanog sadržaja.
English: In this trial, 326 heroin-addicted subjects were randomly assigned to either buprenorphine/naloxone 16 mg per day, 16 mg buprenorphine per day or placebo.
Croatian: U ovom ispitivanju, 326 ispitanika ovisnih o heroinu randomizirano je na 16 mg buprenorfina/naloksona dnevno, 16 mg buprenorfina dnevno, ili placebo.
English: Alcohol may increase drowsiness and may increase the risk of respiratory failure if taken with Zubsolv.
Croatian: Alkohol može pojačati omamljenost i rizik od zatajenja disanja ako se uzima s lijekom Zubsolv.
English: Opioids may produce orthostatic hypotension in ambulatory patients.
Croatian: Opioidi mogu izazvati ortostatsku hipotenziju u pokretnih bolesnika.
English: Oedema peripheral
Croatian: Periferni edem
English: Renal elimination plays a relatively small role (~30 %) in the overall clearance of buprenorphine/naloxone.
Croatian: Eliminacija putem bubrega ima relativno malu ulogu (~30 %) u ukupnom klirensu buprenorfina/naloksona.
English: They must not be taken at the same time as Zubsolv 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 Zubsolv jer biste mogli osjetiti iznenadnu pojavu produljenih i intenzivnih simptoma ustezanja.
English: Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route.
Croatian: Eliminacija bubrezima može biti produljena, jer se 30 % primijenjene doze eliminira putem bubrega.
English: In rats buprenorphine has been found to inhibit lactation.
Croatian: U štakora je pronađeno da buprenorfin inhibira laktaciju.
English: Hyperhidrosis
Croatian: Hiperhidroza
English: Depending upon the findings, the medicinal product may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
Croatian: Ovisno o nalazima, može se prekinuti primjena lijeka, ali uz oprez, kako bi se spriječio nastanak simptoma ustezanja od lijeka i povrat na zlouporabu lijeka.
English: • other central nervous system depressants, other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase central nervous system depression.
Croatian: • drugim depresorima središnjeg živčanog sustava, drugim derivatima opioida (npr. metadon, analgetici i antitusici), određenim antidepresivima, sedativnim antagonistima H1-receptora, barbituratima, drugim anksioliticima koji nisu benzodiazepini, neurolepticima, klonidinom i sličnim tvarima: ove kombinacije povećavaju depresiju središnjeg živčanog sustava.
English: Some risks to opioid misusers and abusers 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: Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Croatian: Lijekovi koji inhibiraju enzim CYP3A4 mogu dovesti do povišenih koncentracija buprenorfina.
English: The tablet contains buprenorphine which is responsible for the treatment of opioid (narcotic) dependence.
Croatian: Tableta sadrži buprenorfin koji je se primjenjuje za liječenje ovisnosti o opioidima (narkoticima).
English: Patients already treated with CYP3A4 inhibitors should have their dose of buprenorphine/naloxone titrated carefully since a reduced dose may be sufficient in these patients (see section 4.5).
Croatian: U bolesnika koji su već primali CYP3A4 inhibitore treba pažljivo titrirati dozu buprenorfina/naloksona, jer snižena doza može biti dostatna u ovih bolesnika (vidjeti dio 4.5).
English: Stopping treatment
Croatian: Prekid liječenja
English: • anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine
Croatian: • antiretrovirotici (koriste se za liječenje HIV-a) poput ritonavira, nelfinavira i indinavira mogu povećati učinke ovog lijeka
English: A patient who is under-dosed with buprenorphine/naloxone may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
Croatian: Bolesnik koji je subdoziran buprenorfinom/naloksonom može nastaviti reagirati na nekontrolirane simptome ustezanja tako da se sam liječi opioidima, alkoholom ili drugim sedativnim hipnoticima poput benzodiazepina.
English: • Remove the tablet as described below.
Croatian: • Izvadite tabletu prema opisu u nastavku.
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone only should be undertaken when objective and clear signs of withdrawal are evident (demonstrated e.g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).
Croatian: Da bi se izbjeglo naglo ustezanje, buprenorfin/nalokson treba se uvesti samo kad objektivni i jasni znakovi ustezanja postanu očiti [pokazuju se, primjerice, rezultatom koji upućuje na blago do umjereno ustezanje na validiranoj Kliničkoj skali ustezanja od opioida (Clinical Opioid Withdrawal Scale, COWS)].
English: Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence.
Croatian: Prije početka liječenja, mora se utvrditi o kojoj se vrsti ovisnosti o opioidima radi (tj. kratkodjelujućim ili dugodjelujućim opioidima), vremenu od zadnje uporabe opioida te stupnju ovisnosti o opioidima.
English: A peri-postnatal study has not been conducted with buprenorphine/naloxone; however, maternal oral administration of buprenorphine at high doses during gestation and lactation resulted in difficult parturition (possible as a result of the sedative effect of buprenorphine), high neonatal mortality and a slight delay in the development of some neurological functions (surface righting reflex and startle response) in neonatal rats.
Croatian: Nije provedeno peripostnatalno ispitivanje buprenorfina/naloksona; međutim, peroralna primjena visokih doza buprenorfina u ženki tijekom gestacije i laktacije rezultirala je otežanim okotom (vjerojatno posljedica sedativnog učinka buprenorfina), visokim neonatalnim mortalitetom i blago odgođenim razvojem nekih neuroloških funkcija (refleks uspravljanja i reakcija trzanja) u novookoćenih štakora.