FrancophonIA/ELRC3.0 huggingface dataset:
English: Consideration should be given to the types of opioid used (that is long- or short-acting opioid), time since last opioid use and the degree of opioid dependence.
Croatian: Prije početka liječenja, mora se utvrditi koja se vrsta opioida koristi (tj. kratkodjelujući ili dugodjelujući opioidi), vrijeme od zadnje uporabe opioida te stupanj ovisnosti o opioidima.
English: How to store Buvidal
Croatian: Kako čuvati Buvidal
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: Do not use this medicine after the expiry date which is stated on the carton or the syringe label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili naljepnici štrcaljke iza oznake EXP.
English: If the patient is switched to treatment with sublingual buprenorphine, this should be done one week after the last weekly dose or one month after the last monthly dose of Buvidal according to the recommendations in Table 1.
Croatian: Ako bolesnik prelazi na liječenja sublingvalnim buprenorfinom, to treba učiniti tjedan dana nakon zadnje tjedne doze ili mjesec dana nakon zadnje mjesečne doze Buvidala , u skladu s preporukama iz Tablice 1.
English: What you need to know before you receive Buvidal You must not receive Buvidal:
Croatian: Što morate znati prije nego počnete primjenjivati Buvidal
English: - Gently pull the needle out of the skin.
Croatian: Slika 6: - Lagano izvadite iglu iz kože.
English: • certain anxiolytics (used to treat anxiety disorders)
Croatian: • određeni anksiolitici (koriste se za liječenje anksioznih poremećaja)
English: Patients should be cautioned to use gabapentinoids (such as pregabalin and gabapentin) concurrently with this product only as directed by their physician (see section 4.4).
Croatian: Bolesnike treba upozoriti da gabapentionide (poput pregabalina i gabapentina) koriste istodobno s ovim lijekom samo prema uputama svojeg liječnika (vidjeti dio
English: No dose modification based on renal function is required, but caution is recommended when dosing subjects with severe renal impairment (see sections 4.2 and 4.4).
Croatian: Nije potrebna prilagodba doze vezano uz funkciju bubrega, ali se preporučuje oprez kod doziranja u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.2 i 4.4).
English: Any attempts to remove the depot should be monitored throughout treatment.
Croatian: Tijekom cijeloga liječenja potrebno je paziti na svaki pokušaj uklanjanja depoa lijeka.
English: Effect of hepatic impairment (change relative to healthy subjects) on pharmacokinetic parameters of buprenorphine following sublingual buprenorphine/naloxone administration (2.0/0.5 mg) in healthy subjects, and in subjects with varied degrees of hepatic impairment Pharmacokinetic
Croatian: Učinak oštećenja jetre (promjena se odnosi na zdrave ispitanika) na farmakokinetičke parametre buprenorfina nakon sublingvalne primjene buprenorfina/naloksona (2,0/0,5 mg) u zdravih ispitanika i u ispitanika s različitim stupnjevima oštećenja jetre Farmakokinetički parametar blago oštećenje jetre (Child-Pugh stupanj A) (n=9)
English: - As soon as the needle has been completely removed from the skin, slowly take the thumb off the plunger and allow the syringe guard to automatically cover the exposed needle (see Figure 8).
Croatian: Čim se igla potpuno izvadi iz kože, polako maknite palac s klipa i pustite da štitnik štrcaljke automatski prekrije izvučenu iglu (vidjeti Sliku 8).
English: If Buvidal treatment is discontinued, its prolonged-release characteristics and any withdrawal symptoms experienced by the patient must be considered, see section 4.4.
Croatian: U slučaju prekida liječenja Buvidalom, treba uzeti u obzir njegova svojstva produljenog oslobađanja i sve simptome ustezanja koje je bolesnik imao, vidjeti dio 4.4.
English: For the new-to-treatment patients, the percentage of patients with illicit opioid-negative urine samples was 0.0% at baseline and 63.0% at the end of the 48-week treatment period.
Croatian: Za bolesnike koji su po prvi put liječeni, postotak bolesnika s negativnim nalazom uzoraka mokraće na nedopuštene opioide bio je 0,0% u početnoj točki, a 63,0% na kraju 48-tjednog razdoblja liječenja.
English: - monoamine oxidase inhibitors (used to treat depression) such as phenelzine, isocarboxazid, iponiazid and tranylcypromine as they may increase the effects of this medicine.
Croatian: - inhibitori monoaminooksidaze (koriste se za liječenje depresije) poput fenelzina, izokarboksazida, iproniazida i tranilcipromina jer mogu povećati učinak ovog lijeka.
English: Buvidal is for single use only.
Croatian: Buvidal je namijenjen samo za jednokratnu primjenu.
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden Phone: +800 2577 2577
Croatian: Ideon Science Park SE-223 70 Lund, Švedska Telefon: +800 2577 2577
English: To avoid precipitating symptoms of withdrawal, treatment with Buvidal should be started when objective and clear signs of mild to moderate withdrawal are evident (see section 4.4).
Croatian: Kako bi se izbjeglo izazivanje simptoma ustezanja, liječenje Buvidalom treba početi kod očitih objektivnih i jasnih znakova blagog do umjerenog ustezanja (vidjeti dio 4.4).
English: The efficacy and safety of Buvidal in the treatment of opioid dependence were established in a pivotal phase 3, randomised, double-blind, double-dummy, active-controlled, flexible-dose study in patients with moderate to severe opioid dependence.
Croatian: Djelotvornost i sigurnost Buvidala u liječenju ovisnosti o opioidima utvrđeni su u randomiziranom, dvostruko slijepom i s dvostrukim placebom, pivotalnom kliničkom ispitivanju faze III s aktivnom kontrolom i fleksibilnom dozom, u bolesnika s umjerenom do teškom ovisnošću o opioidima.
English: Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration can produce opioid dependence.
Croatian: Buprenorfin je parcijalni agonist µ (mi)-opioidnih receptora i kronična primjena dovodi do ovisnosti o opioidima.
English: The prefilled syringe is assembled in a safety device for post-injection needlestick prevention.
Croatian: Napunjena štrcaljka ugrađena je u sigurnosni uređaj za zaštitu od uboda iglom nakon primjene injekcije.
English: It should be injected slowly and completely into the subcutaneous tissue of different areas (buttock, thigh, abdomen, or upper arm), provided there is enough subcutaneous tissue.
Croatian: Treba ga ubrizgati polako i do kraja u potkožno tkivo na jednom od više mogućih područja za primjenu (stražnjica, bedro, trbuh ili nadlaktica), pod uvjetom da ima dovoljno potkožnog tkiva.
English: Camurus AB Ideon Science Park SE-223 70 Lund, Sweden Tel: +800 2577 2577
Croatian: Ideon Science Park SE-223 70 Lund, Švedska Tel: +800 2577 2577
English: Buvidal 8 mg, 16 mg, 24 mg and 32 mg are given weekly.
Croatian: Buvidal od 8 mg, 16 mg, 24 mg i 32 mg daje se tjedno.
English: Discontinuation of treatment may result in a withdrawal syndrome that may be delayed in onset.
Croatian: Prekid liječenja može uzrokovati sindrom ustezanja s odgođenim nastupom.
English: What Buvidal is and what it is used for What you need to know before you use Buvidal How Buvidal is given
Croatian: Što morate znati prije nego počnete primjenjivati Buvidal Kako se primjenjuje Buvidal
English: Buprenorphine showed low tissue and biochemical toxicities when beagles were dosed subcutaneously for one month, rhesus monkeys orally for one month and rats and baboons intramuscularly for six months.
Croatian: Buprenorfin je pokazao nisku tkivnu i biokemijsku toksičnost, kada su psima pasmine bigl tijekom jednog mjeseca davane potkožne injekcije, resus majmunima peroralne doze tijekom jednog mjeseca,
English: Buvidal 64 mg, 96 mg and 128 mg are given monthly.
Croatian: Buvidal od 64 mg, 96 mg, i 128 mg mg daje se mjesečno.
English: - other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions (fits) and pain.
Croatian: Alkohol može pogoršati sedativni učinak ovog lijeka. - druge lijekove koji Vas mogu učiniti pospanim, a koji se koriste za liječenje bolesti poput tjeskobe, nesanice, konvulzija (napadaja) i boli.
English: Buvidal may make you sleepy and dizzy.
Croatian: Buvidal može uzrokovati pospanost i omaglicu.
English: Rash Pruritus Urticaria
Croatian: Pruritus Urtikarija
English: Steadystate exposure is reached at the fourth weekly dose.
Croatian: Izloženost u stanju dinamičke ravnoteže postiže se kod četvrte tjedne doze.
English: For opioid-dependent patients currently receiving buprenorphine treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms.
Croatian: Za bolesnike ovisne o opioidima koji trenutno primaju terapiju buprenorfinom, naltrekson može izazvati iznenadan nastup produljenih i intenzivnih simptoma ustezanja opioida.
English: - Drowsiness: This medicine may cause drowsiness especially when used with alcohol or other central nervous system depressants (substances that slow down some brain activity) such as benzodiazepines, other medicines that reduce anxiety or cause sleepiness, pregabalin or gabapentin.
Croatian: - Pospanost: Ovaj lijek može uzrokovati pospanost, pogotovo kada se uzima s alkoholom ili drugim supresorima središnjeg živčanog sustava (tvari koje usporavaju određenu aktivnost mozga), poput benzodiazepina, ostalih lijekova koji smanjuju tjeskobu ili uzrokuju pospanost,
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of cytolytic hepatitis, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Croatian: Poremećaji su se kretali u rasponu od prolaznih asimptomatskih povišenja jetrenih transaminaza do pojedinačnih izvješća o slučajevima citolitičkog hepatitisa, nekroze jetre, hepatorenalnog sindroma, hepatalne encefalopatije i smrti.
English: Buvidal prolonged-release solution for injection (weekly) EU/1/18/1336/001 [8 mg buprenorphine/0.16 mL]
Croatian: Buvidal otopina za injekciju s produljenim oslobađanjem (za tjednu primjenu) EU/1/18/1336/001 [8 mg buprenorfina/0,16 ml]
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.4 and 5.2).
Croatian: Preporučuje se oprez pri doziranju u bolesnika s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) (vidjeti dijelove 4.4 i 5.2).
English: Administration of Buvidal is restricted to healthcare professionals.
Croatian: Primjena Buvidala ograničena je na zdravstvene radnike.
English: Figure 8:
Croatian: Slika 8:
English: Do not use the safety syringe if the liquid contains particles or is cloudy.
Croatian: Nemojte koristiti sigurnosnu štrcaljku ako tekućina sadrži čestice ili je zamućena.
English: Adverse reactions listed by body system
Croatian: Nuspojave navedene prema organskom sustavu
English: Important information Before administration Administration Disposing of the syringe
Croatian: Važne informacije Prije primjene Primjena
English: - While holding the syringe as shown (see Figure 6), slowly depress the plunger until the plunger head latches between the syringe guard wings and all the solution is injected.
Croatian: Slika 5 - Držeći štrcaljku kako je prikazano (vidjeti Sliku 6), lagano potiskujte klip dok glava klipa ne upadne između krilaca štitnika štrcaljke i ne ubrizga se sva otopina.
English: Pre-filled syringes containing 8 mg, 16 mg, 24 mg, 32 mg, 64 mg, 96 mg and 128 mg solution for injection.
Croatian: Dostupne su sljedeće veličine pakiranja: Napunjene štrcaljke koje sadrže 8 mg, 16 mg, 24 mg, 32 mg, 64 mg, 96 mg i 128 mg otopine za injekciju.
English: The adverse reactions most frequently reported for buprenorphine are headache, nausea, hyperhidrosis, insomnia, drug withdrawal syndrome and pain.
Croatian: Najčešće prijavljivane reakcije na buprenorfin su glavobolja, mučnina, hiperhidroza, nesanica,
English: Superiority of Buvidal versus sublingual buprenorphine/naloxone was met (pre-specified test order) for the secondary endpoint cumulative distribution function (CDF) for percentage of opioid-negative urine samples during treatment weeks 4 to 24 (Table 4).
Croatian: Superiornost Buvidala naspram sublingvalnog buprenorfina/naloksona je pokazana (unaprijed određen redoslijed testova) za kumulativnu funkciju distribucije sekundarne mjere ishoda (eng. cumulative distribution function, CDF) - postotka uzoraka urina koji su negativni na opioide u 4. do 24. tjednu liječenja (Tablica 4).
English: Patients with moderate hepatic impairment should be monitored for signs and symptoms of precipitated opioid withdrawal, toxicity or overdose caused by increased levels of buprenorphine.
Croatian: Bolesnike s umjerenim oštećenjem jetre treba pratiti zbog znakova i simptoma izazvanih ustezanja od opioida, toksičnosti ili predoziranja uzrokovanih povišenim razinama buprenorfina.
English: - a urinary disorder (especially linked to enlarged prostate in men) - thyroid problems - an adrenocortical disorder (e.g. Addison's disease) - gall bladder problems
Croatian: - poremećaj mokraćnog sustava (pogotovo vezano uz povećanu prostatu u muškaraca) - probleme sa štitnjačom
English: Switching from sublingual buprenorphine products to Buvidal Patients treated with sublingual buprenorphine may be switched directly to weekly or monthly Buvidal, starting on the day after the last daily buprenorphine sublingual treatment dose in accordance with the dosing recommendations in Table 1.
Croatian: Prelazak sa sublingvalnog buprenorfina na Buvidal Bolesnici koji se liječe sublingvalnim buprenorfinom mogu izravno prijeći na tjedni ili mjesečni Buvidal, počevši sljedeći dan nakon zadnje terapijske doze sublingvalnog buprenorfina, u skladu s preporukama za doziranje navedenima u Tablici
English: Injection site cellulitis
Croatian: Celulitis na mjestu primjene injekcije
English: 90° (see Figure 5).
Croatian: (vidjeti Sliku 5).
English: Abnormal liver function tests
Croatian: Odstupanja u rezultatima pretraga funkcije jetre
English: Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzymes increased
Croatian: Povišena aspartat aminotransferaza
English: Prolonged-release solution for injection 1 pre-filled syringe with safety device and 1 plunger rod
Croatian: OBLIK I SADRŽAJ Otopina za injekciju s produljenim oslobađanjem 1 napunjena štrcaljka sa sigurnosnim uređajem i 1 štap klipa
English: 8 mg: Pre-filled syringe containing 8 mg buprenorphine in 0.16 mL solution 16 mg: Pre-filled syringe containing 16 mg buprenorphine in 0.32 mL solution 24 mg: Pre-filled syringe containing 24 mg buprenorphine in 0.48 mL solution 32 mg: Pre-filled syringe containing 32 mg buprenorphine in 0.64 mL solution
Croatian: 8 mg: Napunjena štrcaljka koja sadrži 8 mg buprenorfina u 0,16 ml otopine 16 mg: Napunjena štrcaljka koja sadrži 16 mg buprenorfina u 0,32 ml otopine 24 mg: Napunjena štrcaljka koja sadrži 24 mg buprenorfina u 0,48 ml otopine 32 mg: Napunjena štrcaljka koja sadrži 32 mg buprenorfina u 0,64 ml otopine
English: Medical dependence
Croatian: Ovisnost o lijekovima
English: How to use Buvidal
Croatian: Kako se primjenjuje Buvidal
English: The 8 mg, 16 mg, 24 mg and 32 mg strengths contain small amounts of ethanol (alcohol), less than 100 mg per dose.
Croatian: Jačine od 8 mg, 16 mg, 24 mg i 32 mg sadrže male količine etanola (alkohola), manje od 100 mg po dozi.
English: Somnolence Dizziness Migraine Paraesthesia Syncope Tremor
Croatian: Somnolencija Vrtoglavica Migrena Parestezija Sinkopa
English: Read the package leaflet before use Subcutaneous use For single use only Once weekly
Croatian: Supkutana primjena Samo za jednokratnu primjenu Jednom tjedno
English: Buvidal is for administration of healthcare professionals only.
Croatian: Buvidal je namijenjen isključivo za primjenu od strane zdravstvenih radnika.
English: For patients currently receiving naltrexone treatment, the intended therapeutic effects of buprenorphine administration may be blocked by naltrexone.
Croatian: Kod bolesnika koji trenutno primaju terapiju naltreksonom, naltrekson može blokirati ciljane terapijske učinke buprenorfina.
English: 64 mg: Pre-filled syringe containing 64 mg buprenorphine in 0.18 ml solution 96 mg: Pre-filled syringe containing 96 mg buprenorphine in 0.27 ml solution 128 mg: Pre-filled syringe containing 128 mg buprenorphine in 0.36 ml solution
Croatian: 64 mg: Napunjena štrcaljka koja sadrži 64 mg buprenorfina u 0,18 ml otopine 96 mg: Napunjena štrcaljka koja sadrži 96 mg buprenorfina u 0,27 ml otopine 128 mg: Napunjena štrcaljka koja sadrži 128 mg buprenorfina u 0,36 ml otopine
English: Buvidal is intended for subcutaneous administration only.
Croatian: Buvidal je namijenjen samo za potkožnu primjenu.
English: Buprenorphine products have caused precipitated withdrawal symptoms in opioiddependent patients when administered before the agonist effects resulting from recent opioid use or misuse have subsided.
Croatian: Lijekovi koji sadrže buprenorfin doveli do izazivanja simptoma ustezanja u bolesnika ovisnih o opioidima, kada su se primjenjivali prije povlačenja agonističkih učinaka nedavnog uzimanja ili zlouporabe opioida.
English: Buvidal 8 mg, 16 mg, 24 mg and 32 mg contain small amounts of ethanol (alcohol), less than 100 mg per dose.
Croatian: Buvidal od 8 mg, 16 mg, 24 mg i 32 mg sadrže male količine etanola (alkohola), manje od 100 mg po dozi.
English: EU/1/18/1336/003 [24 mg buprenorphine 0.48 mL]
Croatian: EU/1/18/1336/003 [24 mg buprenorfina 0,48 ml]
English: Efficacy variables in a pivotal phase 3, randomised, double-blind, doubledummy, active-controlled, flexible-dose study in patients with moderate to severe opioid dependence
Croatian: Varijable djelotvornosti u pivotalnom, randomiziranom, dvostruko slijepom ispitivanju faze III s dvostrukim placebom i aktivnim komparatorom te fleksibilnom dozom u bolesnika s umjerenom do teškom ovisnošću o opioidima Varijabla djelotvornosti
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min), see sections 4.2 and
Croatian: Preporučuje se oprez pri doziranju u bolesnika s teškim oštećenjem bubrega (klirens kreatinina <30 ml/min) (vidjeti dijelove 4.2 i 5.2).
English: Appropriate precautions, such as to conduct patient follow-up visits with clinical monitoring according to the patient's needs, should be taken when prescribing and dispensing buprenorphine.
Croatian: Treba poduzeti odgovarajuće mjere opreza pri propisivanju i izdavanju buprenorfina kao što su praćenja bolesnika kroz posjete uz klinički nadzor u skladu s bolesnikovim potrebama.
English: Hallucinations Euphoric mood
Croatian: Euforično raspoloženje
English: - While holding the syringe by the needle shield, insert the plunger rod into the plunger stopper by gently rotating the plunger rod clockwise until secured (see Figure 2)
Croatian: - Držeći štrcaljku za štitnik, umetnite štap klipa u čep klipa blagim okretanjem štapa klipa u smjeru kazaljke na satu sve dok nije učvršćen (vidjeti Sliku 2)
English: Buvidal avoids first-pass effects and CYP3A4 inducers (e.g. phenobarbital, carbamazepine, phenytoin or rifampicin) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine.
Croatian: Buvidal zaobilazi metabolizam prvog prolaska kroz jetru i očekuje se slabiji učinak induktora CYP3A4 (npr. fenobarbitala, karbamazepina, fenitoina ili rifampicina) na metabolizam buprenorfina kod istodobne primjene s Buvidalom u usporedbi s istodobnom primjenom sa sublingvalnim buprenorfinom.
English: - Injection should be made into the subcutaneous tissue.
Croatian: Važne informacije - Injekciju treba primijeniti u potkožno tkivo.
English: The study met the primary endpoint of non-inferiority in mean percentage of urine samples negative for illicit opioids during treatment weeks 1 to 24 for the Buvidal group compared with the sublingual buprenorphine/naloxone group (Table 4).
Croatian: Ispitivanje je zadovoljilo primarnu mjeru ishoda - neinferiornosti u srednjoj vrijednosti postotka uzoraka urina koji su bili negativni na nedopuštene opioide od 1. do 24. tjedna liječenja za skupinu liječenja Buvidalom, u usporedbi sa skupinom koja je primala buprenorfin/nalokson (Tablica 4).
English: • The needle shield of the syringe may contain rubber latex that may cause allergic reactions in latex sensitive individuals.
Croatian: • Zaštitni poklopac igle može sadržavati lateks gumu koja može uzrokovati alergijske reakcije kod osoba osjetljivih na lateks.
English: This means a target dose of 24 mg or 32 mg during the first treatment week.
Croatian: To znači da će u prvom tjednu terapije ciljana doza biti 24 mg ili 32 mg.
English: EU/1/18/1336/004 [32 mg buprenorphine/0.64 mL]
Croatian: EU/1/18/1336/004 [32 mg buprenorfina/0,64 ml]
English: Buprenorphine should be used with caution in patients with moderate hepatic impairment (see section 5.2).
Croatian: Buprenorfin treba oprezno primjenjivati u bolesnika s umjerenim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: In particular, patients with concomitant medicinal products and/or comorbidities, should be monitored for signs and symptoms of toxicity, overdose or withdrawal caused by increased or decreased levels of buprenorphine.
Croatian: Posebno treba nadzirati bolesnike koji istodobno uzimaju druge lijekove i/ili imaju druge bolesti, zbog mogućih znakova i simptoma toksičnosti, predoziranja ili ustezanja, uzrokovanih povišenim ili sniženim dozama buprenorfina.
English: EU/1/18/1336/002 [16 mg buprenorphine/0.32 mL]
Croatian: EU/1/18/1336/002 [16 mg buprenorfina/0,32 ml]
English: Figure 7:
Croatian: Slika 7:
English: Conversely, if a patient who is concomitantly treated with Buvidal and a CYP3A4 inhibitor stops treatment with the CYP3A4 inhibitor, the patient should be monitored for symptoms of withdrawal.
Croatian: Za razliku od toga, ako bolesnik koji istodobno prima terapiju Buvidalom i inhibitorom CYP3A4 prekine liječenje inhibitorom CYP3A4, treba ga nadzirati za simptome ustezanja.
English: - alcohol or medicines containing alcohol.
Croatian: Morate uzimati onu dozu koju Vam je propisao Vaš liječnik. - alkohol ili lijekove koji sadrže alkohol.
English: Figure 3:
Croatian: Slika 3:
English: Dose of monthly Buvidal
Croatian: Mjesečni Buvidal
English: - While holding the syringe by the needle shield, insert the plunger rod into the plunger stopper by gently rotating the plunger rod clockwise until secured (see Figure 2).
Croatian: - Držeći štrcaljku za štitnik, umetnite štap klipa u čep klipa blagim okretanjem štapa klipa u smjeru kazaljke na satu sve dok nije učvršćen (vidjeti Sliku 2).
English: Each pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod.
Croatian: Jedno pakiranje sadrži 1 napunjenu štrcaljku s čepom klipa, iglu, zaštitni poklopac za iglu, sigurnosni uređaj i 1 štap klipa.
English: Constipation Vomiting Abdominal pain Flatulence Dyspepsia Dry mouth Diarrhoea Gastrointestinal disorder
Croatian: Bol u abdomenu Flatulencija Dispepsija
English: Cases of acute hepatic injury have been reported in opioid-dependent patients both in clinical studies and in post-marketing adverse reaction reports with medicinal products containing buprenorphine.
Croatian: Slučajevi aktunog oštećenja jetre prijavljeni su vezano uz primjenu lijekova koji sadrže buprenorfin u bolesnika ovisnih o opioidima u kliničkim ispitivanjima i nakon stavljanja lijeka u promet.