FrancophonIA/ELRC3.0 huggingface dataset:
English: Leukocytosis Leukopenia Lymphadenopathy Thrombocytopenia
Maltese: Lewkoċitożi Lewkopenija Limfadenopatija Tromboċitopenija
English: • rash, itching, hives
Maltese: • ażżma, qtugħ ta' nifs, titwib
English: White, capsule shaped tablets, length 10.3 mm and width 8.2 mm, debossed with “11.4” on one side.
Maltese: Pilloli bojod, b'forma ta' kapsula, b'tul ta' 10.3 mm u wisa' ta' 8.2 mm, imnaqqxa b'”11.4” fuq naħa waħda.
English: White, oval tablet, length 6.8 mm and width 4.0 mm
Maltese: Pillola bajda u ovali, b'tul ta' 6.8 mm u wisa' ta' 4.0 mm
English: This product can cause dependence.
Maltese: Dan il-prodott jista' jikkawża dipendenza.
English: • CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of norbuprenorphine Patients receiving Zubsolv should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, azole antifungals such as ketoconazole, itraconazole or macrolide antibiotics)
Maltese: • Inibituri ta' CYP3A4: studju ta' interazzjoni bejn buprenorphine ma' ketoconazole (inibitur qawwi ta' CYP3A4) irriżulta f'żieda fis-Cmax u fl-AUC (erja taħt il-kurva) ta' buprenorphine (madwar 50% u 70%, rispettivament) u, fi grad inqas, ta' norbuprenorphine.
English: Taking Zubsolv
Maltese: Zubsolv
English: White, D-shaped tablets, height 7.3 mm and width 5.65 mm, debossed with “2.9” on one side.
Maltese: Pilloli bojod, b'forma ta' D, b'għoli ta' 7.3 mm u wisa' ta' 5.65 mm, imnaqqxa b'”2.9” fuq naħa waħda.
English: White, diamond shaped tablets, length 9.5 mm and width 8.2 mm, debossed with “8.6” on one side.
Maltese: Pilloli bojod, b'forma ta' djamant, b'tul ta' 9.5 mm u wisa' ta' 8.2 mm, imnaqqxa b'”8.6” fuq naħa waħda.
English: White, oval tablets, length 6.8 mm and width 4.0 mm, debossed with “.7” on one side.
Maltese: Pilloli bojod, ovali, b'tul ta' 6.8 mm u wisa' ta' 4.0 mm, imnaqqxa b'”.7” fuq naħa waħda.
English: • Children and adolescents
Maltese: • Tfal u adolexxenti
English: • naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Maltese: • naltrexone u nalmefene huma antagonisti tal-opjojdi li jistgħu jimblukkaw l-effetti farmakoloġiċi ta' buprenorphine.
English: White, round tablet, 7 mm in diameter
Maltese: Pillola bajda u tonda, b'dijametru ta' 7 mm
English: • some medicines may decrease the effect of Zubsolv.
Maltese: • xi mediċini jistgħu jnaqqsu l-effett ta' Zubsolv.
English: • anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine
Maltese: • antiretrovirali (jintużaw biex jittrattaw l-HIV) bħal ritonavir, nelfinavir, indinavir, jistgħu jżidu l-effetti ta' din il-mediċina
English: • spinning sensation
Maltese: Sensittività eċċessiva
English: medicine dependence, exaggerated feeling of well-being, feelings of hostility
Maltese: dipendenza fuq il-mediċina, sensazzjoni esaġerata li tħossok tajjeb ħafna, sentimenti ta' ostilità
English: Headache
Maltese: Uġigħ
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.
Maltese: Il-kombinazzjoni (4:1) ta' buprenorphine hydrochloride u naloxone hydrochloride ma kinitx mutaġenika f'assaġġ ta' mutazzjoni batterika (Ames test), u ma kinitx klastoġenika f'assaġġ ċitoġeniku in vitro f'limfoċiti umani jew f'test tal-mikronukleu ġol-vini fil-firien.
English: Buprenorphine is metabolised by 14-N-dealkylation and glucuroconjugation of the parent molecule and the dealkylated metabolite.
Maltese: Buprenorphine jiġi metabolizzat permezz ta' 14-N-dealkalizzazzjoni u glukurokonjugazzjoni talmolekula primarja u l-metabolit dealkalizzat.
English: Urine abnormality Albuminuria Dysuria
Maltese: Ħolm anormali Aġitazzjoni Apatija
English: • CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.
Maltese: L-użu fl-istess ħin ta' indutturi ta' CYP3A4 ma' buprenorphine, jista' jnaqqas il-konċentrazzjonijiet ta' buprenorphine fil-plażma, u dan potenzjalment jirriżulta fi trattament subottimali tad-dipendenza fuq l-opjojdi bi buprenorphine.
English: • have poor adrenal gland function (e.g. Addison's disease)
Maltese: • għandek funzjoni batuta tal-glandola tal-kliewi (eż. il-marda ta' Addison)
English: Efficacy and safety data for buprenorphine/naloxone are primarily derived from a one-year clinical trial, comprising a 4-week randomised double blind comparison of buprenorphine/naloxone, buprenorphine and placebo followed by a 48 week safety study of buprenorphine/naloxone.
Maltese: Dejta dwar l-effikaċja u sigurtà għal buprenorphine/naloxone inkisbet primarjament minn prova klinika li damet sena, li tinkludi paragun randomised double blind ta' 4 ġimgħat ta' buprenorphine/naloxone, buprenorphine u plaċebo, segwit minn studju dwar is-sigurtà li dam 48 ġimgħa ta' buprenorphine/naloxone.
English: Zubsolv with food, drink and alcohol
Maltese: Zubsolv ma' ikel, xorb u alkoħol
English: • Naltrexone and nalmefene (drugs used to treat addictive disorders) as they may prevent the therapeutic effects of Zubsolv.
Maltese: • Naltrexone u nalmefene (mediċini użati sabiex jittrattaw disturbi ta' dipendenza fuq id-drogi), għax dawn jistgħu jipprevjenu l-effetti terapewtiċi ta' Zubsolv.
English: 14.0-fold increase
Maltese: Żieda ta' 14.0 darbiet aktar
English: Following intravenous administration, naloxone is rapidly distributed (distribution half-life ~ 4 minutes).
Maltese: Wara l-għoti minn ġol-vini, naloxone jiġi ddistribwit malajr (half-life tad-distribuzzjoni ta' ~4 minuti).
English: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Maltese: Trattament ta' sostituzzjoni għal dipendenza fuq mediċini opjojdi, fil-qafas ta' kura medika, soċjali u psikoloġika.
English: Buprenorphine is a partial agonist at the μ (mu)-opiate receptor and chronic administration produces dependence of the opioid type.
Maltese: Buprenorphine hu agonist parzjali għar-riċettur ta' μ (mu)-opiate, u l-għoti kroniku jikkawża dipendenza tat-tip tal-opjojdi.
English: “2.9” on one side
Maltese: “2.9” fuq naħa waħda
English: “1.4” on one side
Maltese: “1.4” fuq naħa waħda
English: White, round tablets, 7 mm in diameter, debossed with “5.7” on one side.
Maltese: Pilloli bojod, tondi, b'dijametru ta' 7 mm, imnaqqxa b'”5.7” fuq naħa waħda.
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets Zubsolv 1.4 mg / 0.36 mg sublingual tablets Zubsolv 2.9 mg / 0.71 mg sublingual tablets Zubsolv 5.7 mg / 1.4 mg sublingual tablets Zubsolv 8.6 mg / 2.1 mg sublingual tablets Zubsolv 11.4 mg / 2.9 mg sublingual tablets buprenorphine / naloxone
Maltese: 71 mg pilloli għal taħt l-ilsien Zubsolv 5.7 mg/1.4 mg pilloli għal taħt l-ilsien Zubsolv 8.6 mg/2.1 mg pilloli għal taħt l-ilsien Zubsolv 11.4 mg/2.9 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: ZUBSOLV 0.7 mg / 0.18 mg
Maltese: Zubsolv 0.7 mg/0.
English: Zubsolv sublingual tablets are available in six different strengths, differentiated by shape and debossing:
Maltese: Pilloli għal taħt l-ilsien Zubsolv huma disponibbli f'sitt qawwiet differenti, iddifferenzjati skont ilforma u t-tinqix fuqhom:
English: Induction
Maltese: Induzzjoni
English: These include medicines used to treat epilepsy (such as carbamazepine and phenytoin), and medicines used to treat tuberculosis (rifampicin)
Maltese: Dawn jinkludu mediċini użati biex jikkuraw lepilessija (bħal carbamazepine u phenytoin), u mediċini użati biex jikkuraw it-tuberkulożi (rifampicin)
English: Amenorrhoea Ejaculation disorder Menorrhagia Metrorrhagia
Maltese: Disturbi muskoluskeletriċi u tat tessuti konnettivi
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets Zubsolv 1.4 mg / 0.36 mg sublingual tablets Zubsolv 2.9 mg / 0.71 mg sublingual tablets Zubsolv 5.7 mg / 1.4 mg sublingual tablets Zubsolv 8.6 mg / 2.1 mg sublingual tablets Zubsolv 11.4 mg / 2.9 mg sublingual tablets
Maltese: 71 mg pilloli għal taħt l-ilsien Zubsolv 5.7 mg/1.4 mg pilloli għal taħt l-ilsien Zubsolv 8.6 mg/2.1 mg pilloli għal taħt l-ilsien Zubsolv 11.4 mg/2.9 mg pilloli għal taħt l-ilsien
English: The tablet contains buprenorphine which is responsible for the treatment of opioid (narcotic) dependence.
Maltese: Il-pillola fiha buprenorphine, li hu responsabbli għat-trattament ta' dipendenza fuq l-opjojdi (narkotiċi).
English: 11.4 mg / 2.9 mg 3 years
Maltese: 11.4 mg/2.9 mg 3 snin
English: 0.2-fold decrease
Maltese: Żieda ta' 0.2 darbiet aktar
English: “.7” on one side
Maltese: “. 7” fuq naħa waħda
English: Zubsolv 11.4 mg / 2.9 mg sublingual tablets buprenorphine / naloxone
Maltese: Zubsolv 11.4 mg/2.9 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: • anxiety, depression, decreased sexual drive, nervousness, abnormal thinking
Maltese: • ansjetà, tnaqqis, tnaqqis fl-aptit sesswali, nervożiżmu, ħsiebijiet mhux normali
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.
Maltese: Il-kombinazzjoni ta' buprenorphine u naloxone ġiet investigata fi studji dwar it-tossiċità fl-annimali, b'dożi akuti u ripetuti (għal sa 90 jum fil-firien).
English: Each 11.4 mg / 2.9 mg sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' 11.4 mg/2.9 mg fiha 11.4 mg ta' buprenorphine (bħala hydrochloride) u 2.9 mg ta' naloxone (bħala hydrochloride dihydrate).
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).
Maltese: Għal passi ta' 1.4-5.7 mg ta' buprenorphine din it- titrazzjoni hi ggwidata minn evalwazzjoni mill-ġdid tal-istatus kliniku u psikoloġiku tal-pazjent, u m'għandhiex taqbeż doża waħda massima ta' kuljum ta' buprenorphine ta' 17.2 mg (eż. mogħtija bħala 11.4 + 5.7 mg, 2 x 8.6 mg jew 3 x 5.7 mg).
English: • abnormal blood tests swollen, glands (lymph nodes)
Maltese: • testijiet tad-demm b'riżultat mhux normali, glandoli minfuħin (għoqod tal-limfa)
English: Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Maltese: Mediċini li jinibixxu l-enzima CYP3A4 jistgħu jikkawżaw żieda fil-konċentrazzjonijiet ta' buprenorphine.
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets buprenorphine / naloxone
Maltese: Zubsolv 8.6 mg/2.1 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: ZUBSOLV 1.4 mg / 0.36 mg
Maltese: Zubsolv addizzjonali ta' 1.4 mg/0.36 mg jew 2.9 mg/0.
English: Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Maltese: It-trattament huwa intenzjonat għall-adulti u adolexxenti li jkollhom aktar minn 15-il sena, li jkunu qablu li għandhom jingħataw kura għall-vizzju tagħhom.
English: Asthma Dyspnoea Yawning
Maltese: Itwi hawn Ċarrat hawn
English: Hepatitis and hepatic events
Maltese: Epatite u avvenimenti epatiċi:
English: 8.6 mg / 2.1 mg 3 years
Maltese: 8.6 mg/2.1 mg 3 snin
English: In comparative bioavailability studies Zubsolv 11.4/2.9 mg displayed equivalent buprenorphine exposure to 16/4mg (2 x 8/2mg) buprenorphine/naloxone administered as conventional sublingual tablets however Zubsolv 2 x 1.4/0.36 mg displayed 20% lower buprenorphine exposure to 2 x 2/0.5 mg buprenorphine/naloxone administered as conventional sublingual tablets.
Maltese: 36 mg wera esponiment ta' buprenorphine 20% aktar baxx għal 2 x 2/0.5 mg buprenorphine/naloxone mogħti bħala pilloli konvenzjonali għal taħt l-ilsien.
English: Each 0.7 mg / 0.18 mg sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' 0.7 mg/0.18 mg fiha 0.7 mg ta' buprenorphine (bħala hydrochloride) u 0.18 mg ta' naloxone (bħala hydrochloride dihydrate).
English: In patients with severe hepatic insufficiency the use of buprenorphine/naloxone is contraindicated (see section 4.3).
Maltese: F'pazjenti b'insuffiċjenza severa tal-fwied, l-użu ta' buprenorphine/naloxone hu kontraindikat (ara sezzjoni 4.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH
Maltese: PAKKETT TA' 7, 28, u 30 PILLOLA B'QAWWA TA' 8,6 mg / 2,1 mg
English: Influenza Infection Pharyngitis Rhinitis
Maltese: Influwenza Infezzjoni Farinġite Rinite
English: Opioids may produce orthostatic hypotension in ambulatory patients.
Maltese: L-opjojdi jistgħu jipproduċu pressjoni baxxa ortostatika f'pazjenti ambulatorji.
English: The frequency of possible side effects listed below is defined using the following convention:
Maltese: Il-frekwenza tal-effetti sekondarji possibbli elenkata hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja:
English: Sublingual use.
Maltese: Mhux applikabbli.
English: Misuse, abuse and diversion
Maltese: Użu ħażin, abbuż u diverżjoni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH
Maltese: PAKKETT TA' 7, 28, u 30 PILLOLA B'QAWWA TA' 0,7 mg / 0.18 mg
English: Each 1.4 mg / 0.36 mg sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' 1.4 mg/0.36 mg fiha 1.4 mg ta' buprenorphine (bħala hydrochloride) u 0.36 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Zubsolv is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Maltese: Zubsolv jintuża għat-trattament ta' dipendenza fuq mediċini opjojdi (narkotiċi) bħall-eroina jew morfina fl-persuni bill-vizzju tad-doga li jkunu qablu li jiġu ttrattati għall-vizzju tagħhom.
English: Sublingual tablet
Maltese: Deskrizzjoni tal-pillola
English: Pregnancy
Maltese: Parestesija
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets buprenorphine / naloxone
Maltese: Zubsolv 5.7 mg/1.4 mg pilloli għal taħt l-ilsien buprenorphine/naloxone
English: White, capsule shaped tablet, length 10.3 mm and width 8.2 mm
Maltese: Pillola bajda b'forma ta' kapsula, b'tul ta' 10.3 mm u wisa' ta'
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).
Maltese: Studji fl-annimali wrew tnaqqis fil-fertilità tan-nisa f'dożi għoljin (esponiment sistemiku ta' >2.4 drabi tal-esponiment tal-bniedem fid-doża massima rakkomandata ta' 17.2 mg ta' buprenorphine, ibbażat fuq AUC) (ara sezzjoni 5.3).
English: All strengths will be available as packs of 7, 28, and 30 tablets presented in aluminium blisters.
Maltese: Il-qawwiet kollha se jkunu disponibbli bħala pakketti ta' 7, 28, u 30 pillola ppreżentati f'folji talaluminju.
English: These include local reactions, sometimes septic (abscess, cellulitis), potentially serious acute hepatitis, and other acute infections such as pneumonia, endocarditis (see section 4.4).
Maltese: Dawn jinkludu reazzjonijiet lokali, xi kultant settiċi (axxess, ċellulite), epatite akuta potenzjalment serja, u infezzjonijiet akuti oħrajn bħal pnewmonja u endokardite (ara sezzjoni 4.4).
English: White, triangular tablet, base 7.2 mm and height 6.9 mm
Maltese: Pillola bajda u trijangulari, b'bażi ta' 7.2 mm u għoli ta'
English: • urine abnormality
Maltese: Anormalità erettili
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomised to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
Maltese: Fi studju double-blind, double-dummy, ta' gruppi paralleli, li qabbel soluzzjoni etanolika ta' buprenorphine ma' kontroll attiva ta' agonist sħiħ, 162 individwu ntgħażlu b'mod każwali biex jirċievu s-soluzzjoni etanolika għal taħt l-ilsien ta' buprenorphine f'doża ta' 8 mg/jum (doża li hi bejn wieħed u ieħor komparabbli ma' doża ta' 12 mg/jum ta' buprenorphine/naloxone), jew żewġ dożi relattivament baxxi ta' kontroll attiv, li wieħed minnhom kien baxx biżżejjed biex iservi bħala alternattiva għall-plaċebo, matul il-fażi tal-induzzjoni li damet minn 3 sa 10 ijiem, fażi ta' manteniment ta' 16-il ġimgħa, u fażi ta' detossifikazzjoni ta' 7 ġimgħat.
English: Naloxone is metabolised in the liver, primarily by glucuronide conjugation, and excreted in the urine.
Maltese: Naloxone jiġi metabolizzat fil-fwied, l-aktar permezz ta' konjugazzjoni glucuronide, u jitneħħa flawrina.
English: Regular monitoring of liver function is recommended (see section 4.4).
Maltese: Monitoraġġ regolari tal-funzjoni talkliewi hu rakkomandat (ara sezzjoni 4.4).
English: Store in the original package below 25°C in order to protect from moisture.
Maltese: Aħżen fil-pakkett oriġinali f'temperatura taħt 25°C sabiex tilqa' mill-umdità.
English: “5.7” on one side
Maltese: “5.7” fuq naħa waħda
English: Each 8.6 mg / 2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' 8.6 mg/2.1 mg fiha 8.6 mg ta' buprenorphine (bħala hydrochloride) u 2.1 mg ta' naloxone (bħala hydrochloride dihydrate).
English: • some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole and certain antibiotics, may extend the effects of this medicine
Maltese: • xi mediċini antifungali (jintużaw biex jittrattaw infezzjonijiet fungali) bħal ketoconazole, itraconazole u ċerti antibijotiċi, jistgħu jestendu l-effetti ta' din il-mediċina
English: Each 2.9 mg / 0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' 2.9 mg/0.71 mg fiha 2.9 mg ta' buprenorphine (bħala hydrochloride) u 0.71 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Signs of overdose may also include somnolence, amblyopia, miosis, hypotension, nausea, vomiting and/or speech disorders.
Maltese: Sinjali ta' doża eċċessiva jistgħu jinkludu wkoll ngħas, amblijopija, mijożi, pressjoni baxxa, dardir, remettar u/jew disturbi fid-diskors.
English: Amnesia Hyperkinesia Seizure
Maltese: Sindrome epatorenali
English: Each 5.7 mg / 1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien ta' 5.7 mg/1.4 mg fiha 5.7 mg ta' buprenorphine (bħala hydrochloride) u 1.4 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Therefore, dosages must be limited and this combination must be avoided in cases where there is a risk of misuse.
Maltese: Għalhekk, id-dożaġġi jridu jiġu limitati, u din il-kombinazzjoni trid tiġi evitata f'każijiet fejn ikun hemm riskju ta' użu ħażin.
English: Store the blister safely.
Maltese: Aħżen il-folja b'mod sigur.
English: Buprenorphine is an opioid partial agonist/antagonist which binds to the μ and κ (kappa) opioid receptors of the brain.
Maltese: Buprenorphine hu agonist/antagonist parzjali tal-opjojdi li jeħel mar-riċetturi tal-opjojdi μ and κ (kappa) tal-moħħ.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Maltese: PAKKETT TA' 7, 28, u 30 PILLOLA B'QAWWA TA' 5,7 mg / 1,4 mg
English: Pharmacotherapeutic group: Other nervous system drugs, drugs used in addictive disorders, ATC code: N07BC51.
Maltese: Mediċini oħrajn tas-sistema nervuża, mediċini użati f'disturbi ta' dipendenza, Kodiċi ATC:
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.
Maltese: L-għoti fl-istess ħin ta' antagonisti tal-opjojdi (naltrexone, nalmefene) għat-trattament ta' dipendenza fuq l-alkoħol jew fuq l-opjojdi.
English: The availability of six different tablet strengths supports individual dose titration and tapering.
Maltese: Id-disponibiltà ta' sitt qawwiet differenti tal-pillola jappoġġja titrazzjoni u twaqqif gradwali tad-doża individwali.
English: Symptomatic treatment of respiratory depression and standard intensive care measures should be implemented.
Maltese: Trattament sintomatiku ta' tnaqqis respiratorju, u miżuri standard ta' kura intensiva, għandhom jiġu implimentati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
Maltese: PAKKETT TA' 7, 28, u 30 PILLOLA B'QAWWA TA' 1,4 mg / 0.36 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Maltese: PAKKETT TA' 7, 28, u 30 PILLOLA B'QAWWA TA' 2,9 mg / 0,71 mg
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.2 and 5.2).
Maltese: Il-kawtela hi rakkomandata meta jingħata dożaġġ lil pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' <30 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Maltese: PAKKETT TA' 7, 28, u 30 PILLOLA B'QAWWA TA' 11,4 mg / 2,9 mg
English: 1.7-fold increase
Maltese: Żieda ta' 1.7 darbiet aktar
English: Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 11.4 mg ta' buprenorphine (bħala hydrochloride) u 2.9 mg ta' naloxone (bħala hydrochloride dihydrate).
English: 0.7 mg / 0.18 mg
Maltese: 0.7 mg/0.
English: Dietary administration of buprenorphine in the rat at dose levels of 500 ppm or greater produced a reduction in fertility demonstrated by reduced female conception rates.
Maltese: L-għoti ta' buprenorphine mad-dieta fil-firien f'livelli tad-doża ta' 500 ppm jew aktar, ikkawża tnaqqis fil-fertilità li dehret permezz ta' tnaqqis fir-rati ta' konċepiment fin-nisa.
English: When a hepatic event is suspected, further biological and etiological evaluation is required.
Maltese: Meta avveniment epatiku jkun issuspettat, ikun meħtieġ li ssir evalwazzjoni bijoloġika u etjoloġika addizzjonali.
English: Both active substances of Zubsolv, buprenorphine and naloxone, are extensively metabolized in the liver, and the plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment.
Maltese: Iż-żewġ sustanzi attivi ta' Zubsolv, buprenorphine u naloxone, huma estensivament metabolizzati filfwied, u l-livelli fil-plażma instabu li huma ogħla kemm għal buprenorphine kif ukoll għal f'naloxone f'pazjenti b'indeboliment moderat jew sever tal-fwied.
English: • have problems with the biliary tract (e.g. gall bladder, bile duct)
Maltese: • għandek problemi fil-passaġġ diġestiv (eż. il-marrara, il-kanal tal-bili)
English: Buprenorphine/naloxone may cause severe, possibly fatal, respiratory depression in children and non-dependent persons in case of accidental or deliberate ingestion.
Maltese: Buprenorphine/naloxone jistgħu jikkawżaw tnaqqis sever, possibbilment fatali, respiratorju fit-tfal u persuni mhux dipendenti f'każ ta' inġestjoni aċċidentali jew intenzjonata.