FrancophonIA/ELRC3.0 huggingface dataset:
English: Budesonide, Micronised 200µg Dose Inhalation Powder
Maltese: Budesonide, Doża Mikronizzata ta' 200 µg
English: Cyclocaps Beclometason Beclometasone Dipropionate 200µg Units
Maltese: Cyclocaps Beclometason Beclometasone Dipropionate Unitajiet ta' 200 µg
English: Fluticasonpropionat „allen“ Fluticasone Propionate 125µg Dose Pressurised Inhalation,
Maltese: Fluticasonpropionat „allen“ Fluticasone Propionate Doża ta' 125 µg Inalazzjoni taħt Pressjoni, Sospensjoni
English: Belgium Pari Pharma Gmbh
Maltese: Il-Belġju Pari Pharma Gmbh
English: Fluticasone Propionate 125µg Capsule Inhalation Powder, Hard Capsule
Maltese: Fluticasone Propionate 125 µg Kapsula Trab li Jittieħed manNifs, Kapsula Iebsa
English: Luxembourg Glaxosmithkline Pharmaceuticals S.A.
Maltese: Glaxosmithkline Pharmaceuticals S.A.
English: Fluticasonpropionat „allen“ Fluticasone Propionate 250µg Dose Pressurised Inhalation,
Maltese: Fluticasonpropionat „allen“ Fluticasone Propionate Doża ta' 250 µg Inalazzjoni taħt Pressjoni, Sospensjoni
English: Budesonide 0.5mg Ampoule
Maltese: Budesonide 0.5mg Ampulla
English: Astrazeneca Kft.
Maltese: L-Ungerija Astrazeneca Kft.
English: Beclometasone Dipropionate 100µg Actuation, Formoterol Fumarate Dihydrate 6µg Dose
Maltese: Beclometasone Dipropionate Attwazzjoni ta' 100 µg, Formoterol Fumarate Dihydrate Doża ta' 6 µg
English: Fluticasonpropionat „allen“ Fluticasone Propionate 250µg Dose Inhalation Powder
Maltese: Fluticasonpropionat „allen“ Fluticasone Propionate Doża ta' 250 µg Trab Li Jittieħed ManNifs
English: Belgium Elpen Pharmaceutical Co. Inc.
Maltese: Il-Belġju Elpen Pharmaceutical Co.
English: Beclometasone Dipropionate 0,1 Mg Pressurised Inhalation, Solution
Maltese: Beclometasone Dipropionate 0,1 Mg Inalazzjoni taħt Pressjoni, Soluzzjoni
English: Fluticasone Propionate 250 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose
Maltese: Fluticasone Propionate Doża ta' 250 Mcg, Salmeterol Xinafoate Doża ta' 50
English: Fluticasone Propionate 125µg Dose Aerosol
Maltese: Fluticasone Propionate Doża ta' 125 µg Aerosol
English: Budesonide 800µg Units
Maltese: Budesonide Unitajiet ta' 800 µg
English: Glaxosmithkline Gmbh & Co. Kg Flixotide Forte Diskus
Maltese: L-Awstrija GlaxoSmithKline Pharma GmbH Flixotide Diskus Forte
English: Fluticasone Propionate 100 Mcg Dose, Salmeterol Xinafoate 50 Mcg Dose
Maltese: Fluticasone Propionate Doża ta' 100 Mcg, Salmeterol Xinafoate Doża ta' 50
English: Fluticasone Propionate 250µg Capsule Inhalation Powder, Hard Capsule
Maltese: Fluticasone Propionate 250 µg Kapsula Trab li Jittieħed manNifs, Kapsula Iebsa
English: Budesonide, Micronised 400µg Dose Inhalation Powder
Maltese: Budesonide, Doża Mikronizzata ta' 400 µg
English: Cyclocaps Beclometason Beclometasone Dipropionate 100µg Units
Maltese: Cyclocaps Beclometason Beclometasone Dipropionate Unitajiet ta' 100 µg
English: Beclometasone Dipropionate 0,2 Mg Pressurised Inhalation, Solution
Maltese: Beclometasone Dipropionate 0,2 Mg Inalazzjoni taħt Pressjoni, Soluzzjoni
English: Beclometasone Dipropionate 100µg Inhalation, Formoterol Fumarate 6µg Inhalation
Maltese: Beclometasone Dipropionate Inalazzjoni ta' 100 µg, Formoterol Fumarate Inalazzjoni ta' 6 µg
English: Fluticasone Propionate 250µg Dose Inhalation Powder, Pre-Dispensed
Maltese: Fluticasone Propionate 250mcg/Doża Inalazzjoni taħt Pressjoni, Sospensjoni
English: Glaxosmithkline As
Maltese: In-Norveġja Glaxosmithkline As
English: Netherlands Elpen Pharmaceutical Co. Inc.
Maltese: L-Ungerija Elpen Pharmaceutical Co.
English: Luxembourg Elpen Pharmaceutical Co. Inc.
Maltese: Il-Litwanja Elpen Pharmaceutical Co.
English: Fluticasone Propionate 50µg Inhalation
Maltese: Fluticasone Propionate 50 µg Inalazzjoni
English: Formoterol Fumarate Dihydrate 6µg Actuation, Beclometasone Dipropionate Anhydrous 100µg Actuation
Maltese: Formoterol Fumarate Dihydrate Attwazzjoni ta' 6 µg, Beclometasone Dipropionate Attwazzjoni ta' 100 µg Anidruża
English: Salmeterol Xinafoate 50µg Dose, Fluticasone 250µg Dose
Maltese: Salmeterol Xinafoate Doża ta' 50 µg, Fluticasone Doża ta' 250 µg
English: Fluticasone Propionate 500µg
Maltese: Fluticasone Propionate 500 µg Folja
English: Budesonide 0.2mg Dose
Maltese: Budesonide Doża ta' 0.2 mg
English: Salmeterol Xinafoate 50µg Dose, Fluticasone 500µg Dose
Maltese: Salmeterol Xinafoate Doża ta' 50 µg, Fluticasone Doża ta' 500 µg
English: Fluticasone Propionate 250µg Dose Aerosol
Maltese: Fluticasone Propionate Doża ta' 250 µg Aerosol
English: Glaxosmithkline Gmbh & Co. Kg Flixotide Forte
Maltese: L-Awstrija GlaxoSmithKline Pharma GmbH Flixotide
English: Pari Pharma Gmbh
Maltese: Il-Ġermanja Pari Pharma Gmbh
English: Glaxosmithkline Gmbh & Co. Kg Flixotide Diskus
Maltese: L-Awstrija GlaxoSmithKline Pharma GmbH Flixotide Diskus Junior
English: Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 250µg Dose
Maltese: Salmeterol Xinafoate Doża ta' 50 µg, Fluticasone Propionate Doża ta' 250 µg
English: Salmeterol Xinafoate 50µg Dose, Fluticasone Propionate 500µg Dose
Maltese: Salmeterol Xinafoate Doża ta' 50 µg, Fluticasone Propionate Doża ta' 500 µg
English: Fluticasone Propionate 500µg Inhalation, Salmeterol 50µg Inhalation
Maltese: Fluticasone Propionate Inalazzjoni ta' 500 µg, Salmeterol Inalazzjoni ta' 50 µg
English: Budesonide 100µg Units
Maltese: Budesonide Unitajiet ta' 100 µg
English: Glaxosmithkline Pharma Gmbh.
Maltese: Il-Ġermanja Glaxosmithkline Gmbh & Co.
English: Salmeterol 50µg Dose, Fluticasone Propionate 500µg Dose
Maltese: Salmeterol Doża ta' 50 µg, Fluticasone Propionate Doża ta' 500 µg
English: Nebuliser Solution
Maltese: Soluzzjoni Nebulizzatur
English: Fluticasone Propionate 220µg Puff
Maltese: Fluticasone Propionate 250 µg Folja
English: Fluticasone Propionate 500µg Dose Inhalation Powder, Pre-Dispensed
Maltese: Fluticasone Propionate Doża ta' 50 µg Sprej tal-Imnieħer, Sospensjoni
English: Fluticasone Propionate 500 Microgram, Salmeterol Xinafoate 50 Microgram
Maltese: Fluticasone Propionate Doża ta' 500 g, Salmeterol Doża ta' 50 µg
English: This may take 5-10 minutes.
Maltese: Dan jista' jieħu 5-10 minuti.
English: PK Parameter
Maltese: PK Parametru
English: Email: PatientSafetyRoW@indivior.com
Maltese: PatientSafetyRoW@indivior.com
English: Dublin 2
Maltese: Dublin 2 Irlanda
English: Povidone K 30
Maltese: Maize starch Povidone K 30
English: System Organ Class
Maltese: Sistemi klassifika tal-organi
English: Indivior Europe Limited 27 Windsor Place Dublin 2
Maltese: Indivior Europe Limited 27 Windsor Place
English: • thyroid problems
Maltese: • problemi bit-tirojde
English: Date of latest renewal: 26 September 2011
Maltese: Data ta' l-aħħar tiġdid: 26 ta' Settembru 2011
English: CYP 3A inhibitors
Maltese: Inibituri ta' CYP 3A
English: • adrenocortical disorder (e.g. Addison's disease)
Maltese: • disturbi adrenokortikali (eż. il-marda ta' Addison)
English: Initiation therapy (induction)
Maltese: Terapija tal-bidu (induzzjoni)
English: East Yorkshire HU8 7DS, United Kingdom.
Maltese: East Yorkshire HU8 7DS, Ir-Renju Unit.
English: - The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium u togħma naturali ta'
English: The maximum daily dose is 24 mg.
Maltese: Id-doża massima ta' kuljum hi ta' 24 mg.
English: Table 1 summarises adverse reactions reported from pivotal clinical trials in which, 342 of 472 patients (72.5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.
Maltese: Tabella 1 turi fil-qosor ir-reazzjonijiet avversi rrappurtati minn provi kliniċi importanti ħafna li fihom, 342 minn 472 pazjent (72.5%) irrappurtaw reazzjonijiet avversi u reazzjonijiet avversi rrappurtati waqt sorveljanza ta 'wara marketing.
English: East Yorkshire HU8 7DS,
Maltese: Hull, East Yorkshire HU8 7DS
English: Albuminuria Dysuria
Maltese: Albuminurija Disurja
English: Use in adolescents (Age 15-<18)
Maltese: L-użu fl-adolexxenti (Età ta' 15-<18-il sena)
English: Ireland
Maltese: Malta
English: Suboxone contains lactose
Maltese: Suboxone fih lactose
English: Packed in packs of 7 and 28 tablets.
Maltese: Ippakkjat f'pakketti ta' 7 u 28 pillola.
English: Citric acid anhydrous Sodium citrate
Maltese: Citric acid anhydrous
English: 28 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
Maltese: 28 pillola f'pakketti tal-folji tan-Karta/Aluminju/Nylon/Aluminju/PVC.
English: Clinical data confirm that CYP3A4 is responsible for the Ndealkylation of buprenorphine.
Maltese: Dejta klinika tikkonferma li CYP3A4 hi responsabbli għal N-dealkylation ta' buprenorphine.
English: Pharmacokinetic Parameter Suboxone 4 mg Suboxone 8 mg Suboxone 16 mg
Maltese: Suboxone 4 mg Suboxone 8 mg Suboxone 16-il mg
English: CNS depression
Maltese: Depressjoni tas-CNS
English: Statistically significant increases in the incidence of benign testicular interstitial (Leydig's) cell adenomas were observed in all dosage groups.
Maltese: Żidiet statistikament sinifikanti fl-inċidenza ta' adenomi ta' ċelluli interstizjali (ta' Leydig) testikulari beninni ġew osservati fil-gruppi kollha tad-dożaġġ.
English: Patients with rare hereditary problems of galactose intolerance, should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal galactose, m'għandhomx jieħdu din il-mediċina.
English: Side effects reported with Suboxone
Maltese: Effetti sekondarji rraportati b'Suboxone
English: Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see section 4.3 and 5.2).
Maltese: Buprenorphine/naloxone hu kontraindikat f'pazjenti b'indeboliment epatika severa (ara sezzjoni 4.3 u 5.2).
English: Buprenorphine is metabolised by 14-N-dealkylation and glucuroconjugation of the parent molecule and the dealkylated metabolite.
Maltese: Buprenorphine jiġi metabolizzat minn 14-N-dealkylation u glukurokonjugazzjoni tal-molekula oriġinali u l-metabolit dealkylated.
English: Severe Hepatic Impairment (Child-Pugh Class C) (n=8)
Maltese: Indeboliment tal-fwied Sever (Child-Pugh Klassi C) (n = 8)
English: sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine.
Maltese: - antagonisti sedattivi tar-riċettur Hı (użati biex jiġu ttrattati reazzjonijiet allerġiċi) bħal diphenhydramine u chlorphenamine.
English: o 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.
Maltese: o inibituri ta' CYP3A4: studju dwar l-interazzjoni ta' 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, b'mod inqas notevoli, ta' norbuprenorphine.
English: Mild Hepatic Impairment (Child-Pugh Class A) (n=9)
Maltese: Indeboliment tal-fwied ħafif (Child-Pugh Klassi A) (n = 9)
English: Content of the pack and other Information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Due to the lack of data in adolescents (age 15-<18), patients in this age group should be more closely monitored during treatment.
Maltese: Minħabba n-nuqqas ta' dejta fl-adolexxenti (età 15-<18-il sena), il-pazjenti f'dan il-grupp tal-età għandhom jiġu mmonitorjati aktar mill-qrib waqt il-kura.
English: Severe respiratory insufficiency
Maltese: Insuffiċjenza respiratorja severa
English: • This medicine has been prescribed for you.
Maltese: • xi mediċini jistgħu jnaqqsu l-effett ta' Suboxone.
English: Suboxone with food, drink and alcohol
Maltese: Suboxone ma' ikel, xorb u alkoħol
English: Taking Suboxone
Maltese: Tiħux Suboxone
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 24 mg buprenorphine, based on AUC).
Maltese: Studji fl-annimali wrew tnaqqis fil-fertilità femminili f'dożi għoljin (esponiment sistemiku ta' > 2.4 drabi tal-esponiment uman bid-doża massima rakkomandata ta' 24 mg ta' buprenorphine, ibbażat fuq l-AUC).
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as, diazepam, temazepam, alprazolam.
Maltese: • Benzodiazepines (użati biex jiġu ttrattati l -ansjetà jew disturbi fl-irqad) bħal, diazepam, temazepam, alprazolam.
English: Buprenorphine is eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70 %), the rest being eliminated in the urine.
Maltese: Buprenorphine jiġi eliminat fl-ippurgar permezz ta' tneħħija biljari tal-metaboliti glukurokonjugati (70%), u l-bqija jiġi eliminat fl-awrina.
English: Asthma Dyspnoea Yawning
Maltese: Stitikezza Nawsja
English: The availability of doses of 2 mg/0.5 mg and 8 mg/2 mg allows for a downward titration of dosage.
Maltese: Id-disponibilità ta' dożi ta' 2 mg/0.5 mg u 8 mg/2 mg tippermetti li ssir titrazzjoni 'l isfel tad-dożaġġ.
English: Magnesium stearate Acesulfame potassium Natural lemon and lime flavour
Maltese: Sodium citrate Magnesium stearate Acesulfame potassium
English: 6.5 Nature and contents of container 7 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 7 pillola f'pakketti tal-folji tan-Karta/Aluminju/Nylon/Aluminju/PVC.
English: Do not take Suboxone together with alcohol.
Maltese: Tiħux Suboxone mal-alkoħol.
English: Moderate Hepatic Impairment (Child-Pugh Class B) (n=8)
Maltese: (Child-Pugh Klassi B) (n = 8)
English: 2.8-fold increase
Maltese: 2.8- żieda ta' 2.8 darbiet
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: L-użu flimkien (4:1) ta' buprenorphine hydrochloride u naloxone hydrochloride ma kienx mutaġeniku f'assaġġ ta' mutazzjoni batterjali (test ta' Ames), u ma kienx klastoġeniku in vitro f'assaġġ ċitoġenetiku f'limfoċiti umani jew f'test tal-mikronukleu ġol-vini fil-firien.
English: Renal elimination plays a relatively small role (~30 %) in the overall clearance of buprenorphine/naloxone.
Maltese: It-tneħħija mill-kliewi għandha rwol relattivament żgħir (~ 30%) fit-tneħħija globali ta' buprenorphine/naloxone.
English: Naloxone has a mean half-life from plasma of 1.2 hours.
Maltese: Naloxone għandu half-life medja mill-plażma ta' 1.2 siegħa.
English: o naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Maltese: o naltrexone u nalmefene huma antagonista tal-opjojde li jista' jimblokka l-effetti farmakoloġiċi ta' buprenorphine.
English: When a hepatic event is suspected, further biological and etiological evaluation is required.
Maltese: Meta jkun hemm suspett ta' avveniment epatiku, ikun hemm bżonn ta' evalwazzjoni bijoloġika u etjoloġika addizzjonali.
English: Back Pain Arthralgia Muscle spasms Myalgia
Maltese: Uġigħ fid-Dahar Artralġja Spażmi muskolari Mijalġja
English: The concomitant use of monoamine oxidase inhibitors (MAOI) might produce an exaggeration of the effects of opioids, based on experience with morphine (see section 4.5).
Maltese: L-użu konkomitanti ta' inibituri ta' monoamine oxidase (MAOI) jista' jipproduċi esaġerazzjoni taleffetti tal-opjojdi, abbażi tal-esperjenza bil-morfina (ara sezzjoni 4.5).
English: The absorption of buprenorphine is followed by a rapid distribution phase (distribution half-life of 2 to 5 hours).
Maltese: L-assorbiment ta' buprenorphine jiġi segwit minn fażi mgħaġla ta' distribuzzjoni (half-life taddistribuzzjoni ta' minn sagħtejn sa 5 sigħat).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 September 2006
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 26 ta' Settembru 2006
English: Depersonalisation Drug dependence Euphoric mood Hostility
Maltese: Depersonalizzazzjoni Dipendenza fuq id drogi
English: Dosage adjustment and maintenance therapy:
Maltese: Aġġustment tad-dożaġġ u terapija ta' manteniment:
English: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Maltese: Kura ta' sostituzzjoni għal dipendenza fuq drogi li fihom l-oppjojdi, f'qafas ta' kura medika, soċjali u psikoloġika.
English: Suboxone 16 mg/4 mg sublingual tablets are white round biconvex tablets of 10.5 mm with “N16” debossed on one side.
Maltese: Il-pilloli ta' taħt l-ilsien ta' Suboxone 16 mg/4 mg huma bojod, tondi u bikonvessi , , ta'10.5 mm u imnaqqxa bil-“N16” fuq naħa waħda.
English: 1.7-fold increase
Maltese: - żieda ta' 1.7 darbiet
English: • anti-retrovirals (used to treat HIV) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine.
Maltese: • Anti-retrovirali (użati biex tiġi ttrattata l-HIV) bħal ritonavir, nelfinavir, indinavir jistgħu jżidu l-effetti ta' din il-mediċina.
English: o other central nervous system depressants, other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase central nervous system depression.
Maltese: o dipressanti oħrajn tas-sistema nervuża ċentrali, derivattivi oħrajn ta' oppjojdi (eż. methadone, mediċini analġeżiċi u kontra s-sogħla), ċerti antidepressanti, antagonisti sedattivi ta' riċettur H1, barbiturati, mediċini kontra l-ansjetà minbarra benzodiazepines, mediċini newrolettiċi, clonidine u sustanzi relatati: dawn it-taħlitiet iżidu d-depressjoni tas-sistema nervuża ċentrali.
English: Clinical data confirm that CYP3A4 is responsible for the N
Maltese: o indutturi ta' CYP3A4:
English: Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome
Maltese: Epatite akuta Suffejra Sindrome epatorenali
English: PACK OF 7 and 28 TABLETS 16 mg STRENGTH
Maltese: PAKKETT TA' 7 u 28 PILLOLA B'QAWWA TA' 16 mg
English: General warnings relevant to the administration of opioids Opioids may produce orthostatic hypotension in ambulatory patients.
Maltese: Twissijiet ġenerali relevanti għall-amministrazzjoni ta' oppjojdi Oppjojdi jistgħu jipproduċu pressjoni baxxa ortostatika f'pazjenti ambulatorji.
English: Orthostatic hypotension
Maltese: Ortostatika baxxa
English: Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole, macrolide antibiotics).
Maltese: Pazjenti li jirċievu Suboxone għandhom jiġu mmonitorjati mill-qrib, u jista' jkollhom bżonn ta' tnaqqis fid-doża jekk jiġi kkombinat ma' inibituri qawwija ta' CYP3A4 (eż. inibituri ta' protease bħal ritonavir, nelfinavir jew indinavir jew antifungali azole bħal ketoconazole jew itraconazole, antibijotiċi makrolidi).
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated exposure multiples of 3 to 75 times, based on a human daily sublingual dose of 16 mg calculated on a mg/m² basis.
Maltese: Twettaq studju dwar il-kanċeroġeniċità bi buprenorphine/naloxone fil-firien b'dożi ta' 7, 30 u 120 mg/kg/kuljum, b'multipli ta' esponimenti stmati ta' minn 3 sa 75 darba, ibbażat fuq id-doża ta' kuljum ta' 16-il mg fil-bniedem mogħtija taħt l-ilsien ikkalkulata fuq bażi ta' mg/m².
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 ħedla, amblijopja, mijożi, pressjoni baxxa, dardir, rimettar u/jew disturbi fid-diskors.
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
Maltese: • Benzodiazepines użati biex jittrattaw ansjetà jew disturbi fl-irqad bħal diazepam, temazepam, alprazolam.
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent persons.
Maltese: Effetti massimi tal-agonisti tal-oppjojd ġew osservati waqt studji farmakoloġiċi kliniċi f'persuni dipendenti fuq l-oppjojdi.
English: Table 1: Treatment-related adverse reactions reported in clinical trials and post-marketing surveillance of buprenorphine/naloxone
Maltese: Tabella 1: Reazzjonijiet avversi assoċjati mal-kura rrappurtati fil-provi kliniċi u sorveljanza tassuq ta'buprenorphine/naloxone
English: NAME OF THE MARKETING AUTHORISATION HOLDER Indivior Europe Limited
Maltese: FIS-SUQ Indivior Europe Limited
English: Suboxone 2 mg/0.5 mg sublingual tablets are white hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side.
Maltese: Il-pilloli ta' taħt l-ilsien ta' Suboxone 2 mg/0.5 mg huma bojod, bikonvessi eżagonali, , ta' 6.5 mm u imnaqqxa bil-“N2” fuq naħa waħda.
English: PHARMACEUTICAL FORM AND CONTENTS 7 sublingual tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7 pilloli għal taħt l-ilsien
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Maltese: It-tip ta' anormalitajiet ivarja minn żidiet temporanji mingħajr sintomi ta' transaminases fil-fwied sa rapporti ta' każijiet ta' insuffiċjenza tal-fwied, nekrożi tal-fwied, is-sindromu epatorenali, enċefalopatija tal-fwied u mewt.
English: Clinical efficacy
Maltese: Sensittività eċċessiva
English: Elimination of buprenorphine is bi- or tri-exponential, and has a mean half-life from plasma of 32 hours.
Maltese: L-eliminazzjoni ta' buprenorphine hi bi- jew tri-esponenzjali, u għandha half-life medja mill-plażma ta' 32 siegħa.
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 ta' doża ta' 500 ppm jew aktar, ipproduċa tnaqqis fil-fertilità li dehret minn rati mnaqqsa ta' konċepiment femminili.
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4 and 5.2).
Maltese: Ilkawtela hi rakkomandata meta jingħataw dożi lil pazjenti b'indeboliment sever tal-kliewi (eliminazzjoni tal-kreatinina < 30 ml/min) (ara sezzjonijiet 4.4 u 5.2).
English: • alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine (see section 4.7).
Maltese: • xorb alkoħoliku jew mediċini li jkun fihom l-alkoħol, għax l-alkoħol iżid l-effett sedattiv ta' buprenorphine (ara sezzjoni 4.7).
English: Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of Suboxone 2.0/0.5mg (buprenorphine/naloxone) sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment.
Maltese: Tabella 3 tagħti fil-qosor ir-riżultati minn prova klinika li fiha l-espożizzjoni wara l-għoti ta 'doża waħda ta' Suboxone 2.0 / 0.5mg (buprenorphine / naloxone) pillola taħt l-ilsien ġiet iddeterminata f'individwi b'saħħithom, u f'individwi b'indeboliment epatiku.
English: Following intravenous administration, naloxone is rapidly distributed (distribution halflife ~ 4 minutes).
Maltese: Wara l-għoti ġol-vina, naloxone jiġi ddistribwit malajr (half-life tad-distribuzzjoni ta' ~ 4 minuti).
English: Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.
Maltese: Testijiet tal-funzjoni tal-fwied fil-linja bażi u dokumentazzjoni tal-istat tal-epatite virali huma rakkomandati qabel ma tinbeda t-terapija.