FrancophonIA/ELRC3.0 huggingface dataset:
English: An effect of buprenorphine on fertility in animals has not been seen (see section 5.3).
Croatian: Učinak buprenorfina na plodnost u životinja nije zabilježen (vidjeti dio 5.3).
English: Overall, buprenorphine plasma exposure increased approximately 3-fold in subjects with severely impaired hepatic function (see sections 4.2, 4.3 and 4.4).
Croatian: Općenito se izloženost buprenorfinu u plazmi povećala za oko 3 puta u ispitanika s teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.2, 4.3 i 4.4).
English: For patients who were switched from sublingual buprenorphine, the percentage of patients with illicit opioid-negative urine samples was 78.8% at baseline and 84.0% at the end of the 48-week treatment period.
Croatian: Za bolesnike koji su prešli sa sublingvalnog buprenorfina, postotak bolesnika s pozitivnim nalazom uzoraka mokraće na nedopuštene opioide bio je 78,8% u početnoj točki, a 84,0% na kraju 48-tjednog razdoblja liječenja.
English: Buprenorphine is oxidatively metabolised by 14-N-dealkylation to N-desalkyl-buprenorphine (also known as norbuprenorphine) via cytochrome P450 CYP3A4 and by glucuroconjungation of the parent molecule and the dealkylated metabolite.
Croatian: Buprenorfin se oksidativno metabolizira 14-N-dealkiliranjem na N-dezalkilbuprenorfin (poznat i pod nazivom norbuprenorfin) putem citokroma P450 CYP3A4 i glukurokonjugacijom ishodišne molekule i dealkiliranog metabolita.
English: • CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.
Croatian: • induktori CYP3A4 mogu inducirati metabolizam buprenorfina što rezultira smanjenjem razina buprenorfina.
English: Buprenorphine may cause drowsiness particularly when taken together with alcohol or central nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids or hypnotics (see sections 4.5 and 4.7).
Croatian: Buprenorfin može uzrokovati pospanost, osobito ako se uzme zajedno s alkoholom ili depresorima središnjeg živčanog sustava (kao što su benzodiazepini, trankvilizatori, gabapentinoidi ili hipnotici) (vidjeti dio 4.5 i 4.7).
English: Buprenorphine is primarily eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70%), the remainder being eliminated in the urine.
Croatian: Buprenorfin se primarno eliminira stolicom, putem bilijarne ekskrecije glukurokonjugiranih metabolita (70 %), dok se ostatak eliminira urinom.
English: During the 12 weeks with monthly injections, patients in both groups could receive one additional 8 mg weekly Buvidal dose per month, if needed.
Croatian: Tijekom zadnjih 12 tjedana s mjesečnim injekcijama, bolesnici u obje skupine mogli su po potrebi primiti jednom mjesečno dodatnu tjednu dozu Buvidala.
English: After injection, the buprenorphine plasma concentration increases with a median time to maximum plasma concentration (tmax) of 6-10 hours.
Croatian: Nakon injekcije se koncentracija buprenorfina u plazmi povećava, a medijan vremena do postizanja maksimalne koncentracije u plazmi (tmax) iznosi oko 6-10 sati.
English: The recommended starting dose of Buvidal is 16 mg, with one or two additional 8 mg doses at least 1 day apart, to a target dose of 24 mg or 32 mg during the first treatment week.
Croatian: Preporučena početna doza Buvidala je 16 mg, s jednom ili dvije dodatne doze od 8 mg s razmakom od najmanje 1 dan, do ciljane doze od 24 mg ili 32 mg u prvom tjednu liječenja.
English: Precautions to be taken before initiation of treatment
Croatian: Prije početka liječenja treba poduzeti mjere opreza
English: Please note that the smallest injection volume is barely visible in the viewing window as the spring of the safety device “cover” part of the glass cylinder close to the needle.
Croatian: Napominjemo da je najmanji volumen ubrizgavanja jedva vidljiv u kontrolnom prozorčiću jer opruga sigurnosnog uređaja "prekriva" dio staklenog cilindra pokraj igle.
English: Do not use if the safety syringe is broken or the packaging is damaged.
Croatian: Nemojte koristiti ako je sigurnosna štrcaljka slomljena ili je pakiranje oštećeno.
English: Monitoring beyond the weekly and monthly treatment period may be needed.
Croatian: Može biti potrebno praćenje i nakon razdoblja tjednog i mjesečnog liječenja.
English: The most common adverse reactions were injection site pain (8.9%), injection site pruritus (6.1%) and injection site erythema (4.7%).
Croatian: Najčešće nuspojave bile su bol na mjestu primjene injekcije (8,9%), svrbež na mjestu primjene injekcije (6,1%) i eritem na mjestu primjene injekcije (4,7%).
English: Hepatic function should be monitored regularly whilst on treatment.
Croatian: Jetrenu funkciju tijekom liječenja treba redovito pratiti.
English: Maintenance treatment and dose adjustments
Croatian: Terapija održavanja i prilagodbe doze
English: Uncommon side effects (may affect up to 1 in 100 people): - Skin infection at the injection site - A feeling of dizziness or spinning (vertigo)
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - infekcija kože na mjestu primjene injekcije - osjećaj vrtnje (vrtoglavica)
English: Buprenorphine should be used cautiously when co-administered with:
Croatian: Buprenorfin treba koristiti uz oprez kod istodobne primjene s:
English: The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally (into the skin) (see section 4.4).
Croatian: Doza se ne smije davati u krvne žile (intravenski), intramuskularno ni intradermalno (u kožu) (vidjeti dio 4.4).
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 opioids.
Croatian: Preporučuje se uporaba antagonista opioida (tj. naloksona), usprkos skromnom učinku koji taj antagonist može imati u otklanjanju respiratornih simptoma buprenorfina, u usporedbi s njegovim učincima na potpune agoniste opioida.
English: - Take the syringe out of the cardboard box: pick up the syringe by the syringe guard body.
Croatian: - Izvadite štrcaljku iz kartonske kutije: uhvatite štrcaljku za štitnik.
English: Dose-proportional increases in exposure are observed in the dose interval 64 mg to 128 mg.
Croatian: Povećanja izloženosti razmjerna dozi zabilježena su za doze u rasponu od 64 mg do 128 mg.
English: Subcutaneous administration of Buvidal results in significantly lower plasma concentrations of norbuprenorphine metabolite compared to administration of sublingual buprenorphine, due to avoidance of first-pass metabolism.
Croatian: Potkožna primjena Buvidala uzrokuje značajno niže koncentracije metabolita norbuprenorfina u plazmi u usporedbi sa sublingvalnom primjenom buprenorfina, zbog zaobilaženja metabolizma prvog prolaza.
English: Buprenorphine is also metabolised to buprenorphine-3βglucuronide by UGT1A1.
Croatian: Buprenorfin se također metabolizira u buprenorfin3β-glukuronid pomoću UGT1A1.
English: - naltrexone and nalmefene (used to treat addiction disorders) as they can stop Buvidal from working properly.
Croatian: - naltrekson i nalmefen (koriste se za liječenje poremećaja ovisnosti) jer mogu onemogućiti pravilno djelovanje Buvidala.
English: The potential for overdose also exists with a full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining (see section 4.4)
Croatian: Također, postoji mogućnost predoziranja punim agonistom, naročito kad se pokušavaju nadići učinci buprenorfina koji je parcijalni agonist ili kad su razine buprenorfina u plazmi u opadanju (vidjeti dio 4.4)
English: Before administration
Croatian: Prije primjene
English: Table 5 summarises the results of a clinical study in which exposure to buprenorphine was determined following administration of a buprenorphine/naloxone 2.0/0.5 mg sublingual tablet in healthy subjects and in subjects with different degrees of hepatic impairment.
Croatian: Tablica 5 sažeto prikazuje rezultate kliničkog ispitivanja u kojem se određivala izloženost nakon primjene sublingvalne tablete buprenorfina/naloksona od 2,0/0,5 mg u zdravih ispitanika i ispitanika s različitim stupnjem oštećenja jetre.
English: Long-term administration during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Croatian: Dugoročna primjena buprenorfina u zadnjem tromjesečju trudnoće može izazvati sindrom ustezanja u novorođenčeta (npr. hipertoniju, neonatalni tremor, neonatalnu agitaciju, mioklonus ili konvulzije).
English: Renal elimination plays a relatively small role (≈ 30%) in the overall clearance of buprenorphine.
Croatian: Eliminacija putem bubrega ima relativno malu ulogu (≈ 30 %) u ukupnom klirensu buprenorfina.
English: • other opioids such as methadone, certain painkillers and cough medicines.
Croatian: • drugi opioidi poput metadona, određeni lijekovi protiv boli i lijekovi protiv kašlja.
English: Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na poseban i ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: Buprenorphine should be used with care in patients with respiratory insufficiency (e.g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis).
Croatian: Ovaj lijek treba primjenjivati uz oprez u bolesnika s respiratornom insuficijencijom (npr. kronična opstruktivna bolest pluća, astma, plućno srce, smanjena respiratorna rezerva, hipoksija, hiperkapnija, prethodno postojeća depresija disanja ili kifoskolioza).
English: Each pre-filled syringe contains a yellowish to yellow clear liquid.
Croatian: Jedna napunjena štrcaljka sadrži žućkastu do žutu bistru tekućinu.
English: • For patients using heroin or short-acting opioids, the initial dose of Buvidal must not be administered until at least 6 hours after the patient last used opioids.
Croatian: • Za bolesnike koji uzimaju heroin ili kratkodjelujuće opioide, početna doza Buvidala ne smije se davati dok nije proteklo najmanje 6 sati od zadnjeg uzimanja opioida od strane bolesnika.
English: A 1 mL pre-filled syringe (glass, Type I) with plunger stopper (fluoropolymer-coated bromobutyl rubber) with needle (½-inch, 23 gauge, 12 mm) and needle shield (styrene butadiene rubber).
Croatian: Napunjena štrcaljka od 1 ml (staklena, tip I) s čepom klipa (brombutilna guma obložena fluoropolimerom) s iglom (1/2 inča, 23 G, 12 mm) i zaštitni poklopac za iglu (stiren-butadien guma).
English: severe hepatic impairment (Child-Pugh Class C) (n=8)
Croatian: teško oštećenje jetre (Child-Pugh stupanj C) (n=8)
English: Check with your doctor before using Buvidal during breastfeeding as this medicine passes into breast milk.
Croatian: Ako dojite, prije uzimanja Buvidala provjerite sa svojim liječnikom, jer ovaj lijek prelazi u majčino mlijeko.
English: Elimination of buprenorphine from Buvidal is release-rate limited with a terminal half-life ranging from 19 to 25 days.
Croatian: Eliminacija buprenorfina iz Buvidala ograničenu je stopom otpuštanja s terminalnim poluvijekom u rasponu od 19 do 25 dana.
English: You may be switched from weekly and monthly treatment and from monthly to weekly treatment.
Croatian: Možete prelaziti s tjedne terapije na mjesečnu i s mjesečne na tjednu terapiju.
English: Before administration Safety syringe parts:
Croatian: Prije primjene Dijelovi sigurnosne štrcaljke:
English: Figure 1: Safety Syringe: Before Use a) Needle shield, b) Syringe Guard Body, c) Syringe Guard Wings, d) Plunger, e) Plunger Head
Croatian: Slika 1: Sigurnosna štrcaljka: Prije primjene a) zaštitni poklopac igle, b) tijelo štitnika štrcaljke, c) krilca štitnika štrcaljke, d) štap klipa, e) glava klipa
English: Vasodilation Hypotension
Croatian: Vazodilatacija Hipotenzija
English: 5.2 Pharmacokinetic properties Weekly Buvidal
Croatian: 5.2 Farmakokinetička svojstva Tjedni Buvidal
English: Opioids should be used with caution in patients with myxoedema, hypothyroidism, or adrenal cortical insufficiency (e.g. Addison's disease).
Croatian: Opioide je potrebno koristiti uz oprez u bolesnika s miksedemom, hipotireoidizmom ili insuficijencijom adrenalnog korteksa (npr. Addisonova bolest).
English: Buprenorphine has minor to moderate influence on the ability to drive and use machines when administered to opioid-dependent patients.
Croatian: Buprenorfin malo do umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima kad se primjenjuje u bolesnika ovisnih o opioidima.
English: Taking too much of a gabapentinoid may lead to death because both medicines can cause very slow and shallow breathing (respiratory depression).
Croatian: Uzimanje prevelike količine gabapentinoida može uzrokovati smrt jer oba lijeka mogu uzrokovati vrlo sporo i plitko disanje (respiratornu depresiju).
English: In the double-blind, phase 3 efficacy trial, injection site-related adverse reactions were observed in 36 (16.9%) of the 213 patients (5% of the administered injections) in the Buvidal treatment group.
Croatian: U dvostruko slijepom ispitivanju faze III, u kojem se ispitivala djelotvornost, zabilježene su nuspojave vezane uz mjestu primjene injekcije kod 36 (16,9%) od 213 bolesnika (5% primijenjenih injekcija) u skupini liječenih Buvidalom.
English: moderate hepatic impairment (Child-Pugh Class B) (n=8)
Croatian: umjereno oštećenje jetre (Child-Pugh stupanj B) (n=8)
English: Treatment with monthly Buvidal can be started after treatment initiation with weekly Buvidal, in accordance with the dose conversion in Table 2 and once patients have been stabilised on weekly treatment (four weeks or more, where practical).
Croatian: Liječenje mjesečnim Buvidalom može započeti nakon uvodnog liječenja tjednim Buvidalom, u skladu s konverzijom doze u Tablici 2- i nakon što su bolesnici stabilizirani na tjednom liječenju (četiri tjedna ili više kad je to praktično).
English: For management of acute pain during continued use of Buvidal, a combination of use of opioids with high mu-opioid receptor affinity (e.g. fentanyl), non-opioid analgesics and regional anaesthesia might be necessary.
Croatian: Za liječenje akutne boli tijekom kontinuirane primjene Buvidala, može biti potrebna kombinirana primjena opioida s visokim afinitetom za µ (mi) opioidne receptore (primjerice fentanil), neopioidnih analgetika i lokalne anestezije.
English: • Administration should be made into the subcutaneous tissue
Croatian: • Lijek treba primijeniti u potkožno tkivo
English: The safety and efficacy buprenorphine in children and adolescents below 16 years of age have not been established (see section 4.4).
Croatian: Sigurnost i djelotvornost buprenorfina u djece i adolescenata mlađih od 16 godina nisu još ustanovljene (vidjeti dio 4.4).
English: Do not uncap the safety syringe until you are ready to inject.
Croatian: Nemojte skidati zaštitni poklopac igle sa sigurnosne štrcaljke dok niste spremni za ubrizgavanje.
English: Name and address of the manufacturer(s) responsible for batch release Rechon Life Science AB
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Rechon Life Science AB
English: Safety syringe parts
Croatian: Dijelovi sigurnosne štrcaljke
English: If you use too much buprenorphine, you must immediately seek medical attention as overdose may cause serious and life-threatening breathing problems.
Croatian: Ako uzmete previše buprenorfina, morate odmah zatražiti liječničku pomoć, jer prekomjerna doza može uzrokovati teške i po život opasne probleme s disanjem.
English: Buvidal may trigger withdrawal symptoms in methadone-dependent patients.
Croatian: Buvidal može izazvati simptome ustezanja u bolesnika koji su ovisni o metadonu.
English: To minimise the risk of misuse, abuse and diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine.
Croatian: Kako bi se minimizirala opasnost od pogrešne primjene, zlouporabe i prosljeđivanja lijeka u nedopuštene svrhe, treba poduzeti odgovarajuće mjere opreza pri propisivanju i izdavanju buprenorfina.
English: A number of cases of death due to respiratory depression have been reported for patients being treated with buprenorphine, particularly when used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Croatian: Kod liječenja buprenorfinom prijavljeni su smrtni slučajevi zbog depresije disanja, osobito u bolesnika kod kojih se buprenorfin primjenjivao u kombinaciji s benzodiazepinima (vidjeti dio 4.5) ili kad se buprenorfin nije primjenjivao u skladu s propisanim uputama.
English: Take-home use or self-administration of the product by patients is not allowed.
Croatian: Nije dopušteno izdavati lijek za primjenu u kući ili samostalnu primjenu od strane bolesnika.
English: - if you start to breathe more slowly or weakly than usual (respiratory depression).
Croatian: Ovo mogu biti znakovi životno ugrožavajuće alergijske reakcije. - ako počnete disati sporije ili slabije nego obično (respiratorna depresija).
English: Buvidal prolonged-release solution for injection (monthly) EU/1/18/1336/005 [64 mg buprenorphine/0.18 mL] EU/1/18/1336/006 [96 mg buprenorphine/0.27 mL] EU/1/18/1336/007 [128 mg buprenorphine/0.36 mL]
Croatian: Buvidal otopina za injekciju s produljenim oslobađanjem (primjena jednom mjesečno) EU/1/18/1336/005 [64 mg buprenorfina/0,18 ml] EU/1/18/1336/006 [96 mg buprenorfina/0,27 ml] EU/1/18/1336/007 [128 mg buprenorfina/0,36 ml]
English: - Handle the safety syringe carefully to avoid a needle stick.
Croatian: • Pažljivo rukovati sigurnosnom štrcaljkom, kako biste izbjegli ubod iglom.
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, antipsychotics, clonidine and related substances.
Croatian: • drugim supresorima središnjeg živčanog sustava: Drugi derivati opioida (npr. metadon, analgetici i antitusici), određeni antidepresivi, sedativni antagonisti H1-receptora, barbiturati, drugi anksioliticima koji nisu benzodiazepini, antipsihotici, klonidin i slične tvari.
English: Stopping treatment may cause withdrawal symptoms.
Croatian: Prekid liječenja može prouzročiti simptome ustezanja lijeka.
English: Baseline liver function tests and documentation of viral hepatitis status are recommended prior to starting therapy.
Croatian: Prije početka terapije preporučuje se napraviti i dokumentirati osnovne pretrage funkcije jetre i status virusnog hepatitisa.
English: Chronic toxicity studies in rat and dog of the vehicle used for Buvidal revealed no special hazard for humans.
Croatian: Ispitivanja kronične toksičnosti farmaceutskog nosača (vehikl) korištenog za Buvidal, provedena u štakora i psa, nisu otkrila posebnu opasnost za ljude.
English: There are no or limited data on effects of buprenorphine on human fertility.
Croatian: Nema podataka o učincima buprenorfina na plodnost ljudi ili su ograničeni.
English: Elimination of buprenorphine from Buvidal is release-rate limited with a terminal half-life ranging from 3 to 5 days.
Croatian: Eliminacija buprenorfina iz Buvidala ograničena je stopom otpuštanja s terminalnim poluvijekom u rasponu od 3 do 5 dana.
English: Patients in the sublingual buprenorphine/naloxone group (n = 215) received weekly placebo injections during the first 12 weeks and monthly placebo injections during the last 12 weeks, plus daily sublingual buprenorphine/naloxone tablets during the complete treatment period (8 mg to 24 mg during the first 12 weeks and 8 mg to 32 mg during the last 12 weeks).
Croatian: Bolesnici u skupini koja je primala sublingvalni buprenorfin/nalokson (n = 215), primali su injekcije placeba tjedno tijekom prvih 12 tjedana, a potom mjesečnu injekciju placeba tijekom zadnjih 12 tjedana i sublingvalne tablete buprenorfina/naloksona svaki dan tijekom cijelog razdoblja liječenja (8 mg do 24 mg tijekom prvih 12 tjedana, a 8 mg do 32 mg tijekom zadnjih 12 tjedana).
English: Do not use the safety syringe after the expiration date shown on the cardboard box or on the syringe label.
Croatian: Nemojte koristiti sigurnosnu štrcaljku nakon isteka datuma roka valjanosti navedenog na kartonskoj kutiji ili naljepnici štrcaljke.
English: Safety syringe parts:
Croatian: Dijelovi sigurnosne štrcaljke:
English: A drop of liquid may be seen at the end of the needle.
Croatian: Na kraju igle može biti vidljiva kapljica tekućine.
English: The safety and efficacy of buprenorphine in children below the age of 16 years have not been established (see section 4.2).
Croatian: Sigurnost i djelotvornost buprenorfina u djece mlađe od 16 godina nisu ustanovljene (vidjeti dio 4.2).
English: In patients with severe hepatic impairment, the use of buprenorphine is contraindicated (see section 4.3).
Croatian: U bolesnika s teškim oštećenjem jetre primjena buprenorfina je kontraindicirana (vidjeti dio 4.3).
English: During the 48-week treatment period, patients could be transitioned between weekly and monthly injections with Buvidal and between doses (8 mg to 32 mg weekly Buvidal and 64 mg to 160 mg monthly Buvidal) according to the physician's clinical judgement.
Croatian: Tijekom 48-tjednog razdoblja liječenja, bolesnici su mogli prelaziti s tjednih na mjesečne injekcije Buvidala i obrnuto, te prelaziti s jedne na drugu dozu (8 mg do 32 mg Buvidala tjedno i 64 mg do 160 mg Buvidala mjesečno), prema kliničkog prosudbi liječnika.
English: Steady-state exposure is reached at the fourth monthly dose.
Croatian: Izloženost u stanju dinamičke ravnoteže postiže se kod četvrte mjesečne doze.
English: Initiation of treatment in patients not already receiving buprenorphine Patients not previously exposed to buprenorphine should receive a sublingual buprenorphine 4 mg dose and be observed for an hour before the first administration of weekly Buvidal to confirm tolerability to buprenorphine.
Croatian: Početak liječenja bolesnika koji prethodno nisu primali buprenorfin Bolesnici koji prethodno nisu izloženi buprenorfinu trebaju dobiti sublingvalni buprenorfin u dozi od 4 mg i biti na promatranju jedan sat prije prve primjene tjednog Buvidala, kako bi se potvrdilo podnošenje buprenorfina.
English: There are no or limited data from the use of buprenorphine in pregnant women.
Croatian: Nema podataka ili postoje ograničeni podaci o primjeni buprenorfina/naloksona u trudnica.
English: Treatment difference (%)a (95% CI)
Croatian: SL BPN/NX Razlika u liječenju (%)a (95 % CI)
English: Patients in the Buvidal group (n = 213) received weekly injections (16 mg to 32 mg) during the first 12 weeks followed by monthly injections (64 mg to 160 mg) during the last 12 weeks, plus daily doses of sublingual placebo tablets during the complete treatment period.
Croatian: Bolesnici u skupini koja je primala Buvidal (n = 213) primali su injekcije tjedno (16 mg do 32 mg) tijekom prvih 12 tjedana, a zatim mjesečno (64 mg do 160 mg) tijekom zadnjih 12 tjedana te dnevne doze sublingvalnih tableta placeba tijekom cijelog razdoblja liječenja.
English: Dose-proportional increases in exposure are observed in the dose interval 8 mg to 32 mg.
Croatian: Povećanja izloženosti razmjerna dozi zabilježena su za doze u rasponu od 8 mg do 32 mg.
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden
Croatian: Ideon Science Park SE-223 70 Lund, Švedska
English: Do not use the safety syringe if the liquid contains visible particles or is cloudy.
Croatian: Nemojte koristiti sigurnosnu štrcaljku ako tekućina sadrži vidljive čestice ili je zamućena.
English: A maximum of one supplemental Buvidal 8 mg dose may be administered at an unscheduled visit between regular weekly and monthly doses, based on individual patient's temporary needs.
Croatian: Kod nezakazanog posjeta između redovnih tjednih i mjesečnih doza može se primijeniti najviše jedna dodatna doza Buvidala od 8 mg, na osnovi individualnih privremenih potreba bolesnika.