FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people): - Infection, influenza, sore throat and painful swallowing, runny nose - Swollen glands (lymph nodes) - Hypersensitivity - Decreased appetite - Anxiety, agitation, depression, hostility, nervousness, abnormal thinking, paranoia - Sleepiness, feeling dizzy, migraine, burning or tingling in hands and feet, fainting, tremor,
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - Infezzjoni, influwenza, uġigħ fil-griżmejn u wġigħ meta tibla', imnieħer inixxi - Glandoli minfuħin (għoqod tal-limfa) - Sensittività eċċessiva - Tnaqqis fl-aptit - Ansjetà, aġitazzjoni, depressjoni, ostilità, nervożità, ħsieb anormali, paranojja - Tħossok bi ngħas, tħossok stordut, emigranja, sensazzjoni ta' ħruq u tnemnim fl-idejn u s saqajn, ħass ħażin, rogħda, żieda fit-tensjoni tal-muskoli, disturbi fid-diskors - Għajnejn idemmgħu, twessigħ jew tidjiq anormali tal-ħabba (il-parti skura tal-għajn)
English: In rats there were no adverse effects on fertility of general reproductive function.
Maltese: Fil-firien, ma kien hemm l-ebda effetti avversi fuq il-funzjoni riproduttiva ġenerali.
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).
Maltese: Is-superjorità ta' Buvidal kontra buprenorphine/naloxone għal taħt l-ilsien ġiet milħuqa (ordni tat-test speċifikata minn qabel) għall-funzjoni ta' distribuzzjoni kumulattiva (CDF, cumulative distribution function) tal-punt aħħari sekondarju għal perċentwali ta' kampjuni tal-awrina negattivi għall-opjojdi matul il-ġimgħat 4 sa 24 tat-trattament (Tabella 4).
English: - The active substance is buprenorphine - The other ingredients are soybean phosphatidylcholine, glycerol dioleate, ethanol anhydrous
Maltese: TA' EĊĊIPJENTI Sustanzi mhux attivi: Soybean phosphatidylcholine, glycerol dioleate, ethanol anhydrous
English: Norbuprenorphine is a µ-opioid agonist with weak intrinsic activity.
Maltese: Norbuprenorphine hu agonist ta' μ-opjojd b'attività intrinsika dgħajfa.
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
Maltese: L-effett ta' indeboliment epatiku (bidla relattiva għal individwi b'saħħithom) fuq parametri farmakokinetiċi ta' buprenorphine wara l-għoti ta' buprenorphine/naloxone taħt l-ilsien (2.0/0.5 mg) f'individwi b'saħħithom, u f'individwi bi gradi differenti ta' indebboliment tal-fwied
English: 64 mg prolonged-release solution for injection Each pre-filled syringe contains 64 mg buprenorphine 96 mg prolonged-release solution for injection Each pre-filled syringe contains 96 mg buprenorphine 128 mg prolonged-release solution for injection Each pre-filled syringe contains 128 mg buprenorphine For the full list of excipients, see section 6.1.
Maltese: U KWANTITATTIVA 64 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Kull siringa mimlija għal-lest fiha 64 mg buprenorphine 96 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Kull siringa mimlija għal-lest fiha 96 mg buprenorphine 128 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Kull siringa mimlija għal-lest fiha 128 mg buprenorphine Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Elimination of buprenorphine from Buvidal is release-rate limited with a terminal half-life ranging from 3 to 5 days.
Maltese: L-eliminazzjoni ta' buprenorphine minn Buvidal hija limitata mir-rata ta' tneħħija b'half-life terminali li tvarja minn 3 sa 5 ijiem.
English: Parameter mild hepatic impairment (Child-Pugh Class A) (n=9)
Maltese: (Child-Pugh Klassi A)
English: Adverse reactions listed by body system
Maltese: Reazzjonijiet avversi elenkati skont is-sistema tal-ġisem
English: - certain antifungal medicines (used to treat fungal infections) such as ketoconazole, itraconazole as they may increase the effects of this medicine.
Maltese: - ċertu mediċini antifungali (jintużaw biex jittrattaw infezzjonijiet fungali) bħal ketoconazole, itraconazole, għax jistgħu jżidu l-effetti ta' din il-mediċina.
English: Buvidal with alcohol
Maltese: Buvidal mal-alkoħol
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.
Maltese: Tabella 5 tagħti fil-qosor ir-riżultati minn prova klinika li fiha l-esponiment wara l-għoti ta' pillola ta' buprenorphine/naloxone 2.0/0.5 mg taħt l-ilsien ġie ddeterminat f'individwi b'saħħithom, u f'individwi bi gradi differenti ta' indeboliment tal-fwied.
English: Vasodilation Hypotension
Maltese: Differenza fittrattament
English: Baseline liver function tests and documentation of viral hepatitis status are recommended prior to starting therapy.
Maltese: Testijiet tal-funzjoni tal-fwied fil-linja bażi u dokumentazzjoni tal-istat tal-epatite virali huma rakkomandati qabel ma tinbeda t-terapija.
English: Renal elimination plays a relatively small role (≈ 30%) in the overall clearance of buprenorphine.
Maltese: It-tneħħija mill-kliewi għandha rwol relattivament żgħir (≈ 30%) fit-tneħħija globali ta' buprenorphine.
English: • alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative effect of buprenorphine (see section 4.7).
Maltese: • xorb alkoħoliku jew prodotti mediċinali li jkun fihom l-alkoħol għax l-alkoħol iżid l-effett sedattiv ta' buprenorphine (ara sezzjoni 4.7).
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]
Maltese: 32 mL] EU/1/18/1336/003 [24 mg buprenorphine 0.48 mL] EU/1/18/1336/004 [32 mg buprenorphine/0.
English: • UGT1A1 inhibitors may affect the systemic exposure of buprenorphine.
Maltese: • Inibituri ta' UGT1A1 jistgħu jaffettwaw l-esponiment sistemiku ta' buprenorphine.
English: Symptomatic treatment of respiratory depression, following standard intensive care measures, should be instituted.
Maltese: Trattament sintomatiku ta' tnaqqis respiratorju, u miżuri standard ta' kura intensiva, għandhom jiġu implimentati.
English: Buvidal 8 mg prolonged-release solution for injection Buvidal 16 mg prolonged-release solution for injection Buvidal 24 mg prolonged-release solution for injection Buvidal 32 mg prolonged-release solution for injection Buvidal 64 mg prolonged-release solution for injection Buvidal 96 mg prolonged-release solution for injection Buvidal 128 mg prolonged-release solution for injection buprenorphine
Maltese: Buvidal 8 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Buvidal 16 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Buvidal 24 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Buvidal 32 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Buvidal 64 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Buvidal 96 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni Buvidal 128 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
English: Buprenorphine is primarily eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70%), the remainder being eliminated in the urine.
Maltese: Buprenorphine jitneħħa primarjament fl-ippurgar permezz ta' tneħħija biljari tal-metaboliti glukurokonjugati (70%), bil-bqija jitneħħa fl-awrina.
English: Reporting suspected adverse reactions after authorisation of the medical product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Buprenorphine should be used with caution in patients with moderate hepatic impairment (see sections 4.2 and 5.2).
Maltese: Buprenorphine għandu jintuża b'attenzjoni f'pazjenti b'indeboliment moderat tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Severe hepatic impairment
Maltese: Infezzjoni Influwenza Farinġite
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.
Maltese: 227 pazjent b'dipendenza fuq l-opjojdi moderata sa severa, li minnhom 190 pazjent qalbu minn buprenorphine għal taħt l-ilsien (bi jew mingħajr naloxone), u 37 pazjent ma kienu qatt irċevew trattament b'buprenorphine.
English: Total clearance of buprenorphine is approximately 68 L/h.
Maltese: It-tneħħija totali ta' buprenorphine hija bejn wieħed u ieħor 68 L/siegħa.
English: The first dose of this medicine will be given to you at least 24 hours after you last used methadone.
Maltese: L-ewwel doża ta' din ilmediċina se tingħata lilek mill-inqas 24 siegħa wara l-aħħar darba li użajt methadone.
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.
Maltese: Għal pazjenti li qatt ma kienu rċevew dan it-trattament, il perċentwali ta' pazjenti b'kampjuni tal-awrina negattivi għall-opjojdi illegali kien ta' 0.0% fil-linja bażi u 63.0% fit-tmiem tal-perjodu tat-trattament li dam 48 ġimgħa.
English: Pre-filled syringe
Maltese: Tnaqqis fl-aptit
English: • A small air bubble may be seen, which is normal.
Maltese: • Tista' tara bużżieqa żgħira tal-arja, li huwa normali.
English: - macrolide antibiotics (used to treat bacterial infections) such as clarithromycin and erythromycin as they may increase the effects of this medicine.
Maltese: - Antibijotiċi makrolidi (jintużaw biex jittrattaw infezzjonijiet batteriċi) bħal clarithromycin u erythromycin, għax jistgħu jżidu l-effetti ta' dan il-mediċina.
English: Hypertonia Speech disorders
Maltese: indeboliment moderat talfwied
English: It is used to treat opioid dependence in patients who are also receiving medical, social and psychological support.
Maltese: Trattament ta' dipendenza fuq mediċini opjojdi, fil-qafas ta' kura medika, soċjali u psikoloġika.
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.
Maltese: L-effikaċja u s-sigurtà ta' Buvidal fit-trattament ta' dipendenza fuq l-opjojdi kienu determinati fi studju kruċjali ta' fażi 3 b'doża flessibbli, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, double-dummy, ikkontrollat b'mod attiv, li sar fuq pazjenti b'dipendenza fuq l-opjojdi moderata sa severa.
English: Buvidal avoids first-pass effects and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine.
Maltese: (eż. inibituri tal-protease bħal ritonavir, nelfinavir jew indinavir, jew antifungali azole bħal ketoconazole jew itraconazole, jew antibijotiċi makrolidi) huma mistennija li jkollhom inqas effetti fuq il-metaboliżmu ta' buprenorphine meta jingħataw flimkien ma' Buvidal meta mqabbla ma' meta jingħataw flimkien ma' buprenorphine li jingħata taħt l-ilsien.
English: If the patient vomits, precautions must be taken to prevent aspiration.
Maltese: Jekk il-pazjent jirremetti, wieħed għandu joqgħod attent sabiex jiġi evitat li r-rimettar ikun aspirat.
English: Preliminary symptoms of overdose may also include excessive sweating, somnolence, amblyopia, miosis, hypotension, nausea, vomiting and / or speech disorders.
Maltese: Sintomi preliminari ta' doża eċċessiva jistgħu jinkludu wkoll għaraq eċċessiv, ngħas, amblijopija, mijożi, pressjoni baxxa, dardir, rimettar u/jew disturbi fid-diskors.
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).
Maltese: L-istudju laħaq il-punt primarju aħħari ta' nuqqas ta' inferjorità f'perċentwali medju ta' kampjun talawrina negattiv għal opjojdi illegali matul il-ġimgħat 1 sa 24 tat-trattament għall-grupp ta' Buvidal meta mqabbel mal-grupp ta' buprenorphine/naloxone għal taħt l-ilsien (Tabella 4).
English: After injection, the buprenorphine plasma concentration increases with a median time to maximum plasma concentration (tmax) of 6-10 hours.
Maltese: Wara l-injezzjoni, il-konċentrazzjoni fil-plażma ta' buprenorphine tiżdied b'ħin medjan għallkonċentrazzjoni massima fil-plażma (tmax) ta' 6-10 sigħat.
English: Arthralgia Back pain Myalgia Muscle spasms Neck pain Bone pain
Maltese: X'għandek tkun taf qabel ma tuża Buvidal
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.
Maltese: Għal pazjenti li kienu maqluba minn buprenorphine għal taħt l-ilsien, il-perċentwali ta' pazjenti b'kampjuni tal-awrina negattivi għall-opjojdi illegali kien ta' 78.8% fil-linja bażi u 84.
English: Buvidal 8 mg, 16 mg, 24 mg, 32 mg Soybean phosphatidylcholine Glycerol dioleate
Maltese: Buvidal 8 mg, 16 mg, 24 mg u 32 mg fih ammonti żgħar ta' etanol (alkoħol), anqas minn 100 mg għal kull doża.
English: Dose-proportional increases in exposure are observed in the dose interval 8 mg to 32 mg.
Maltese: Żidiet proporzjonali għad-doża fl-esponiment huma osservati fl-intervall bejn id-dożi ta' 8 mg sa 32 mg.
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
Maltese: 8 mg: Siringa mimlija għal-lest li fiha 8 mg ta' buprenorphine f'soluzzjoni ta' 0.16 mL 16 mg: Siringa mimlija għal-lest li fiha 16 mg ta' buprenorphine f'soluzzjoni ta' 0.
English: The injection site reactions were all mild or moderate in severity and most events were transient.
Maltese: Ir-reazzjonijiet fis-sit tal-injezzjoni kienu kollha ħfief għall-moderati fis-severità u l-maġġoranza tal-avvenimenti kienu temporanji.
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
Maltese: 96 mg: Siringa mimlija għal-lest li fiha 96 mg ta' buprenorphine f'soluzzjoni ta' 0.27 mL 128 mg: Siringa mimlija għal-lest li fiha 128 mg ta' buprenorphine f'soluzzjoni ta' 0.36 mL Kif jidher Buvidal u l-kontenut tal-pakkett
English: EU/1/18/1336/004 [32 mg buprenorphine/0.64 mL]
Maltese: EU/1/18/1336/005 [64 mg buprenorphine/0.
English: • CYP3A4 inducers may induce the metabolism of buprenorphine resulting in decreased buprenorphine levels.
Maltese: • Indutturi ta' CYP3A4 jistgħu jinduċu l-metaboliżmu ta' buprenorphine li jirriżulta fi tnaqqis tal-livelli ta' buprenorphine.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: Dose-proportional increases in exposure are observed in the dose interval 64 mg to 128 mg.
Maltese: Żidiet proporzjonali għad-doża fl-esponiment huma osservati fl-intervall bejn id-dożi ta' 64 mg sa 128 mg.
English: Figure 1: Safety Syringe: Before Use a) Needle shield, b) Syringe Guard Body, c) Syringe Guard Wings, d) Plunger, e) Plunger Head
Maltese: Qabel l-Użu a) Protezzjoni tal-labra, b) Ilqugħ tal-Parti Ċentrali tas-Siringa, c) Ilqugħ tal-Ġwienaħ tas-Siringa, d) Planġer, e) Ras tal-Planġer
English: Limhamn
Maltese: Anzjani
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe respiratory insufficiency
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1
English: severe hepatic impairment (Child-Pugh Class C) (n=8)
Maltese: (Child-Pugh Klassi Ċ)
English: Rechon Life Science AB Soldattorpsvägen 5 216 13 Limhamn Sweden
Maltese: 216 13 Limhamn l-Iżvezja
English: Acute toxicity of buprenorphine was determined in mice and rats following oral and parenteral (intravenous, intraperitoneal) administration.
Maltese: Tossiċità akuta ta' buprenorphine kienet determinata fi ġrieden u firien wara l-għoti orali u parenterali (ġol-vini, intraperitonalment).
English: Do not use this medicine after the expiry date which is stated on the carton or the syringe label after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq it-tikketta wara EXP.
English: See section 6.6 for administration instructions.
Maltese: Ara sezzjoni 6.6 għal istruzzjonijiet dwar l-għoti.
English: Infection Influenza Pharyngitis Rhinitis
Maltese: .2 Tagħrif farmakokinetiku
English: - The needle shields of the safety syringe may contain rubber latex that may cause allergic reactions in latex-sensitive individuals.
Maltese: - Il-protezzjoni tal-labra tas-siringa tas-sigurtà jista' jkun fihom lastku tal-latex li jista' jikkawża reazzjonijiet allerġiċi f'individwi sensittivi għal-latex.
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.
Maltese: Għall-immaniġġjar ta' wġigħ akut waqt użu kontinwu ta' Buvidal, tista' tkun neċessarja kombinazzjoni ta' użu ta' opjojdi b'affinità għolja mar-riċettur mu-opjojde (eż. fentanyl), analġeżiċi mhux tal-opjojdi u anestesija lokali.
English: Buvidal 96 mg prolonged-release solution for injection buprenorphine
Maltese: Buvidal 96 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
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.
Maltese: Il-firxa ta' anormalitajiet tvarja minn żidiet temporanji mingħajr sintomi fit-transaminases tal-fwied, sa rapport tal-każijiet ta' epatite ċitolitika, insuffiċjenza tal-fwied, nekrożi tal-fwied, sindrome epatorenali, enċefalopatija tal-fwied u mewt.
English: EXPIRY DATE
Maltese: Camurus AB
English: EU/1/18/1336/002 [16 mg buprenorphine/0.32 mL]
Maltese: EU/1/18/1336/001 [8 mg buprenorphine/0.
English: When a hepatic event is suspected, further biological and aetiological evaluation is required.
Maltese: Meta avveniment epatiku jkun issuspettat, ikun meħtieġ li ssir evalwazzjoni bijoloġika u etjoloġika addizzjonali.
English: Buvidal 128 mg prolonged-release solution for injection buprenorphine
Maltese: Buvidal 128 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
English: • The needle shield of the syringe may contain rubber latex that may cause allergic reactions in latex sensitive individuals.
Maltese: • Il-protezzjoni tal-labra tas-siringa jista' jkun fiha lastku tat-tip latex li jista' jikkawża reazzjonijiet allerġiċi f'individwi sensittivi għal-latex.
English: It is very important to keep all your appointments to receive Buvidal.
Maltese: Huwa importanti ħafna li tmur għall-appuntamenti kollha tiegħek biex tirċievi Buvidal.
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.4 and 5.2).
Maltese: Ilkawtela hi rakkomandata meta jingħata dożaġġ lil pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' < 30 mL/min) (ara sezzjonijiet 4.4 u 5.2).
English: Malaise
Maltese: Depressjoni
English: Buvidal 24 mg prolonged-release solution for injection buprenorphine
Maltese: Buvidal 24 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
English: - monoamine oxidase inhibitors (used to treat depression) such as phenelzine, isocarboxazid, iponiazid and tranylcypromine as they may increase the effects of this medicine.
Maltese: Rifampcicin jista' jnaqqas l-effett ta' Buvidal. - inibituri ta'monoamine oxidase (jintużaw biex jittrattaw id-depressjoni) bħal phenelzine, isocarboxazid, iponiazid u tranylcypromine, għax jistgħu jżidu l-effetti ta' din il-mediċina.
English: Figure 5
Maltese: Figura 5).
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ (mu) and κ (kappa) opioid receptors of the brain.
Maltese: Buprenorphine hu agonist/antagonist parzjali tal-opjojdi li jeħel mar-riċetturi tal-opjojdi μ (mu) u κ (kappa) tal-moħħ.
English: Buvidal 64 mg, 96 mg, 128 mg Soybean phosphatidylcholine Glycerol dioleate N-Methylpyrrolidone
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa (1) mimlija għal-lest li fiha 128 mg ta' buprenorphine
English: There are no or limited data on effects of buprenorphine on human fertility.
Maltese: M'hemmx dejta jew hemm dejta limitata dwar l-effetti ta' buprenorphine fuq il-fertilità tal-bniedem.
English: Figure 1: Safety Syringe: Before Use a) Needle shield b) Syringe Guard Body c) Syringe Guard Wings d) Plunger, e) Plunger Head
Maltese: Qabel l-Użu a) Protezzjoni tal-labra b) Ilqugħ tal-Parti Ċentrali tas-Siringa c) Ilqugħ tal-Ġwienaħ tas-Siringa d) Planġer, e) Ras tal-Planġer
English: The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally (into the skin) (see section 4.4).
Maltese: Id-doża m'għandhiex tingħata b'mod intravaskulari (ġol-vini), intramuskolari jew intradermikament (ġol-ġilda) (ara sezzjoni 4.4).
English: Interaction with co-administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine.
Maltese: Linterazzjoni ma' indutturi u inibituri li jingħataw flimkien ġiet determinata fi studji bl-użu ta' buprenorphine transmukożali u transdermali.
English: 5.2 Pharmacokinetic properties Monthly Buvidal
Maltese: Kif jingħata Buvidal
English: Assessment of long-term treatment is based on 48-week data.
Maltese: L-evalwazzjoni ta' trattament fit-tul hija bbażata fuq dejta ta' 48 ġimgħa.
English: Buvidal 64 mg prolonged-release solution for injection buprenorphine
Maltese: Buvidal 64 mg soluzzjoni li terħi l-mediċina fuq tul ta' żmien għall-injezzjoni buprenorphine
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.
Maltese: Matul il-perjodu ta' trattament li dam 48 ġimgħa, il-pazjenti setgħu jkunu maqluba bejn injezzjonijiet ta' kull ġimgħa u ta' kull xahar b'Buvidal u bejn dożi (8 mg sa 32 mg kull ġimgħa ta' Buvidal u 64 mg sa 160 mg kull xahar ta' Buvidal) skont il-ġudizzju kliniku tat-tabib.
English: EU/1/18/1336/003 [24 mg buprenorphine 0.48 mL]
Maltese: EU/1/18/1336/007 [128 mg buprenorphine/0.
English: A small air bubble may be seen, which is normal.
Maltese: Tista' tara bużżieqa żgħira tal-arja, li huwa normali.
English: Method of administration
Maltese: Ideon Science Park