FrancophonIA/ELRC3.0 huggingface dataset:
English: Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 5.7 mg ta' buprenorphine (bħala hydrochloride) u 1.4 mg ta' naloxone (bħala hydrochloride dihydrate).
English: A dietary dose of 100 ppm (estimated exposure approximately 2.4 x for buprenorphine at a human dose of 17.2 mg buprenorphine/naloxone based on AUC, plasma levels of naloxone were below the limit of detection in rats) had no adverse effect on fertility in females.
Maltese: (esponiment stmata ta' madwar 2.4x għal buprenorphine f'doża umana ta' 17.2 mg buprenorphine/naloxone ibbażata fuq l-AUC, il-livelli ta' naloxone fil-plażma kienu taħt il-limitu ta' osservazzjoni fil-firien), u ma kellhomx effetti avversi fuq il-fertilità tan-nisa.
English: Anxiety
Maltese: Astenja
English: Undesirable effects were based on the known pharmacological activity of opioid agonistic and/or antagonistic substances.
Maltese: L-effetti mhux mixtieqa kienu bbażati fuq l-attività farmakoloġika magħrufa ta' agonisti tal-opjojdi u/jew sustanzi antagonistiċi.
English: Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.
Maltese: Hu rakkomandat li jsiru testijiet tal-funzjoni tal-fwied fil-linja bażi u dokumentazzjoni tal-istat talepatite virali qabel ma tinbeda t-terapija.
English: Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 8.6 mg ta' buprenorphine (bħala hydrochloride) u 2.1 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Buprenorphine is eliminated in the faeces by biliary excretion of the glucuroconjugated metabolites (70 %), the rest being eliminated in the urine.
Maltese: Buprenorphine jitneħħa fl-ippurgar permezz ta' tneħħija biljari tal-metaboliti glukurokonjugati (70%), bil-bqija jitneħħa fl-awrina.
English: 2.7-fold increase
Maltese: Żieda ta' 2.7 darbiet aktar
English: If the patient vomits, care must be taken to prevent aspiration of the vomitus.
Maltese: Jekk il-pazjent jirremetti, wieħed għandu joqgħod attent sabiex jiġi evitat li r-rimettar ikun aspirat.
English: • Starting treatment of Zubsolv whilst dependent on heroin:
Maltese: • Kif tibda l-kura b'Zubsolv meta tkun dipendenti fuq l-eroina:
English: 1.2-fold increase
Maltese: Żieda ta' 1.2 darbiet aktar
English: Zubsolv 11.4 mg / 2.9 mg sublingual tablets
Maltese: Zubsolv 11.4 mg/2.9 mg pilloli għal taħ t l-ilsien
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 triesponenzjali, u għandha half-life medja mill-plażma ta' 32 siegħa.
English: 11.3-fold increase
Maltese: Żieda ta' 11.3 darbiet aktar
English: There are small deviations in buprenorphine dose proportionality exposure parameters as well as deviations from strict compositional proportionality for the three lower strengths (2.9/0.71, 1.4/0.36, and 0.7/0.18 mg) compared to the three higher dose presentations.
Maltese: Hemm devjazzjonijiet żgħar fil-parametri tal-esponiment għall-proporzjonalità tad-doża ta' buprenorphine kif ukoll devjazzjonijiet mill-proporzjonalità kompożizzjonali stretta għat-tliet qawwiet aktar baxxi (2.9/0.71, 1.4/0.36, u 0.7/0.18 mg) meta mqabbla mat-tliet preżentazzjonijiet tad-doża ogħla.
English: Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 0.7 mg ta' buprenorphine (bħala hydrochloride) u 0.18 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Cough
Maltese: Mejt
English: Acne
Maltese: Akne
English: ZUBSOLV 2.9mg / 0.71 mg
Maltese: 36 mg jew 2.9 mg/0.71 mg kuljum.
English: Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 2.9 mg ta' buprenorphine (bħala hydrochloride) u 0.71 mg ta' naloxone (bħala hydrochloride dihydrate).
English: The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly
Maltese: • Indutturi ta' CYP3A4:
English: Caution is recommended when dosing patients with severe renal impairment (creatinine clearance <30 ml/min) (see sections 4.4 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 4.4 u 5.2).
English: 2.8-fold increase
Maltese: Żieda ta' 2.8 darbiet aktar
English: • migraines, dizziness, fainting, increase in muscle tension, tingling, drowsiness
Maltese: • emigranji, sturdament, ħass ħażin, żieda fit-tensjoni tal-muskoli, tnemnim, ngħas
English: A carcinogenicity study with buprenorphine/naloxone was conducted in rats at doses of 7, 30 and 120 mg/kg/day, with estimated dose multiples of 3 to75 times, based on a Zubsolv equivalent human daily sublingual dose of 11.4 mg of buprenorphine 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/jum, b'multipli stmati tad-doża ta' 3 sa 75 darba, ibbażati fuq doża umana ekwivalenti ta' Zubsolv ta' kuljum minn taħt l-ilsien ta' 11.4 mg ta' buprenorphine ikkalkulata fuq bażi ta' mg/m².
English: Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Maltese: Kull pillola għal taħt l-ilsien fiha 1.4 mg ta' buprenorphine (bħala hydrochloride) u 0.36 mg ta' naloxone (bħala hydrochloride dihydrate).
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets
Maltese: Zubsolv 5.7 mg/1.4 mg pilloli għal taħ t l-ilsien
English: • flu-like symptoms, infection, sore throat and painful swallowing, runny nose
Maltese: • sintomi bħal tal-influwenza, infezzjoni, uġigħ fil-griżmejn u wġigħ meta tibla', imnieħer inixxi
English: In this trial, 326 heroin-addicted subjects were randomly assigned to either buprenorphine/naloxone 16 mg per day, 16 mg buprenorphine per day or placebo.
Maltese: F'dan l-istudju, 326 individwu bil-vizzju tal-eroina ntgħażlu b'mod każwali biex jirċievu jew buprenorphine/naloxone 16 mg kuljum, 16 mg buprenorphine kuljum, jew plaċebo.
English: Appearance
Maltese: Ansjetà
English: 1.6-fold increase
Maltese: .9 Doża eċċessiva
English: Fold here Tear here
Maltese: ISTRUZZJONIJIET DWAR L­UŻU
English: Never open in advance as the tablet is sensitive to moisture
Maltese: Korriment u avvelenament u komplikazzjonijiet ta' xi proċedura
English: Medical withdrawal
Maltese: TAL-PRODOTT MEDIĊINALI
English: to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data).
Maltese: Rari ħafna (<1/10,000), Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The primary study comparison was to assess the efficacy of buprenorphine and buprenorphine/naloxone individually against placebo.
Maltese: Il-paragun tal-istudju primarju kien biex jevalwa l-effikaċja ta' buprenorphine u buprenorphine/naloxone b'mod individwali kontra l-plaċebo.
English: This product should be used with care in patients with asthma or respiratory insufficiency (e.g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (curvature of spine leading to potential shortness of breath)).
Maltese: Dan il-prodott għandu jintuża b'attenzjoni f'pazjenti bl-ażżma jew insuffiċjenza respiratorja (eż. mard pulmonari ostruttiv kroniku, cor pulmonale, tnaqqis fir-riserva respiratorja, ipossija, iperkapnija, tnaqqis respiratorju li kien jeżisti minn qabel jew kifoskoljożi (kurvatura tas-sinsla li twassal għal qtugħ potenzjali tan-nifs)).
English: Asthenia Chest Pain Chills Pyrexia Malaise Pain
Maltese: GĦAMLA FARMAĊEWTIKA Pillola għal taħt l-ilsien
English: The most commonly reported treatment related adverse reactions reported during the pivotal clinical trials were constipation and symptoms commonly associated with drug withdrawal (i.e. insomnia, headache, nausea, hyperhidrosis and pain).
Maltese: L-aktar avvenimenti avversi relatati mat-trattament li ġew irrappurtati b'mod komuni matul il-provi kliniċi importanti ħafna kienu stitikezza u sintomi komunement assoċjati ma' sintomi ta' meta wieħed jieqaf jieħu l-opjojdi (i.e. insomnja, uġigħ ta' ras, dardir, iperidrożi u wġigħ).
English: Precautions to be taken before induction
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Below is a list of examples of these types of medicines: - other opioid containing medicines such as methadone, certain pain killers and cough suppressants - some anti-depressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate and monoamine oxidase inhibitors (MAOIs) may increase the effects of this medicine - sedative Hı receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine - barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital - tranquilisers (used to cause sleep or sedation) such as chloral hydrate - clonidine (used to treat high blood pressure) and related medicines may extend the effects of this medicine
Maltese: Hawn taħt hawn lista ta' eżempji ta' dawn it-tipi ta' mediċini: - mediċini oħrajn li fihom l-opjojdi bħal methadone, ċerti mediċi għal kontra l-uġigħ, soppressanti tas-sogħla - xi antidepressanti (jintużaw biex jittrattaw id-tnaqqis) bħal isocarboxazid, phenelzine, selegiline, tranylcypromine, valproate u inibituri ta' monoamine oxidase (MAOIs) jistgħu jżidu l-effetti ta' din il-mediċina - antagonisti tar-riċettur sedattiv Hı (jintużaw biex jittrattaw reazzjonijiet allerġiċi) bħal diphenhydramine u chlorphenamine - barbiturates (jintużaw biex jikkawżaw l-irqad jew sedazzjoni) bħal phenobarbital, secobarbital - kalmanti (jintużaw biex jikkawżaw l-irqad jew sedazzjoni) bħal chloral hydrate - clonidine (jintuża biex jittratta pressjoni tad-demm għolja) u mediċini relatati, jistgħu jestendu l-effetti ta' din il-mediċina
English: Table 3: Effect of hepatic impairment on pharmacokinetic parameters of buprenorphine and naloxone following administration (change relative to healthy subjects) PK Parameter
Maltese: Tabella 3: L-effett ta' indeboliment tal-fwied fuq il-parametri farmakokinetiċi ta' buprenorphine u naloxone wara l-għoti (bidla fir-rigward ta' individwi b'saħħithom) Parametru PK Indeboliment Ħafif tal-Fwied
English: Other medicines and Zubsolv
Maltese: Kif tieħu Zubsolv
English: The active substances are buprenorphine and naloxone.
Maltese: Is-sustanzi attivi huma buprenorphine u naloxone.
English: Class
Maltese: Komuni
English: Back Pain Arthralgia Muscle spasms Myalgia
Maltese: Ugigħ fid-Dahar Artralġija Spażmi talmuskoli
English: Remove just one section from the blister pack, tearing it along the perforated line.
Maltese: Neħħi sezzjoni waħda biss mill-pakkett bil-folji, billi ċċartu matul illinja mtaqqba.
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets
Maltese: Zubsolv 8.6 mg/2.1 mg pilloli għal taħ t l-ilsien
English: Zubsolv disintegrates usually within 40 seconds, however it may take 5 to 10 minutes for the patient to feel complete tablet disappearance from the mouth.
Maltese: Zubsolv normalment jiddiżintegra fi żmien 40 sekonda, madankollu, pazjent jista' jieħu minn 5 sa 10 minuti biex iħoss li l-pillola sparixxiet kompletament mill-ħalq.
English: Peak plasma concentrations are achieved approximately 90 minutes after sublingual administration.
Maltese: Il-konċentrazzjonijiet massimi fil-plażma jintlaħqu madwar 90 minuta wara l-għoti minn taħt l-ilsien.
English: Orthostatic hypotension
Maltese: Pressjoni baxxa ortostatika
English: Zubsolv tablet strength
Maltese: Tinqix fuq il-pillola Zubsolv
English: Hypertension Vasodilatation
Maltese: Infezzjoni vaġinali
English: Renal elimination may be prolonged since 30 % of the administered dose is eliminated by the renal route.
Maltese: L-eliminazzjoni mill-kliewi tista' tittawwal billi 30% tad-doża mogħtija tiġi eliminata mill-kliewi.
English: Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingћata b'riċetta speċjali u ristretta tat-tabib (ara Anness I: Sommarju talKaratteristiċi tal-Prodott, sezzjoni 4.2).
English: • heat stroke
Maltese: Stitikezza Dardir
English: How to store Zubsolv
Maltese: X'fih Zubsolv
English: Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome
Maltese: Epatite Epatite akuta Suffejra Nekrożi talfwied
English: Amblyopia Lacrimal disorder
Maltese: Albuminurija Disurija
English: • Starting treatment of Zubsolv whilst dependent on methadone: If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Zubsolv therapy.
Maltese: • Għal pazjenti li jirċievu l-methadone, id-doża tal-methadone għandha titnaqqas sa massimu ta' 30 mg/jum qabel il-bidu tat-terapija bi buprenorphine/naloxone.
English: Buprenorphine/naloxone may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Maltese: Buprenorphine/naloxonejista' jikkawża n-ngħas, l-aktar jekk jittieħed flimkien mal-alkoħol jew sustanzi li jikkawżaw tnaqqis tas-sistema nervuża ċentrali (bħal kalmanti, sedattivi jew ipnotiċi) (ara sezzjoni 4.5).
English: Hepatic encephalopathy Syncope
Maltese: Enċelopatija talfwied
English: White, diamond shaped tablet, length 9.5 mm and width 8.2 mm
Maltese: Pillola bajda b'forma ta' djamant, b'tul ta' 9.5 mm u wisa' ta'
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to 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 insuffiċjenza tal-fwied, nekrożi tal-fwied, sindrome epatorenali, enċefalopatija tal-fwied u mewt.
English: If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
Maltese: Jekk buprenorphine jingħata li xi individwi mhux dipendenti fuq l-opjojdi, li ma jkunux tolleranti għall-effetti tal-opjojdi, tnaqqis respiratorju potenzalment fatali jista' jseħħ.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: AH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: This may involve taking a combination of different strengths, but your daily dose should not exceed 17.2mg of buprenorphine.
Maltese: Dan jista' jinvolvi li inti tieħu taħlita ta' qawwiet differenti, iżda d-doża tiegħek ta' kuljum m'għandhiex taqbeż 17.2 mg ta' buprenorphine.
English: In patients with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone (see sections 4.2 and 4.4).
Maltese: F'pazjenti li jkunu dipendenti ħafna fuq id-drogi, l-għoti inizjali ta' buprenorphine jista' jikkawża sindrome ta' meta wieħed jieqaf jieħu l-opjojdi li jkun simili għal dak assoċjat ma' naloxone (ara sezzjonijiet 4.2 u 4.4).
English: Zubsolv tablet description Zubsolv tablet debossing
Maltese: Qawwa tal-pillola Zubsolv buprenorphine/naloxone
English: In many cases the presence of pre-existing mitochondrial impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Maltese: F'ħafna każijiet, il-preżenza ta' indeboliment mitokondrjali li kien jeżisti minn qabel (mard ġenetiku, anormalitajiet fl-enzimi tal-fwied, infezzjoni bil-virus tal-epatite B jew epatite C, abbuż tal-alkoħol, anoressija, l-użu fl-istess ħin ta' mediċini oħrajn li potenzjalment epatotossiċi) u injettar tad-drogi li jkun għadu għaddej, jista' jkollhom rwol kawżattiv jew kontributorju.
English: The lowest dose studied represented exposure multiples of 1x for buprenorphine and 5 x for naloxone at the maximum human therapeutic dose calculated on a mg/m² basis.
Maltese: L-aktar doża baxxa studjata kienet tirrappreżenta multipli ta' esponimenti ta' 1x għal buprenorphine u 5x għal naloxone flogħla doża terapewtika umana kkalkulata fuq bażi ta' mg/m².
English: Zubsolv is not interchangeable with other buprenorphine products.
Maltese: Zubsolv ma jistax jinbidel ma' prodotti oħra li fihom buprenorphine.
English: - one tablet of Zubsolv 2.9 mg / 0.71 mg each day
Maltese: - pillola Zubsolv waħda 2.9 mg/0.
English: A number of cases of death due to respiratory depression have been reported, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Maltese: Numru ta' każijiet ta' mewt minħabba tnaqqis respiratorju ġew irrappurtati, partikularment meta buprenorphine intuża flimkien ma' benzodiazepines (ara sezzjoni 4.5), jew meta buprenorphine ma ntużax skont l-informazzjoni fuq ir-riċetta.
English: Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious.
Maltese: Xi rapporti ta' aċċessjonijiet, rimettar, dijarea, u testijiet tal-funzjoni tal-fwied b'riżultat għoli kienu kkunsidrati bħala serji.
English: Zubsolv is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support.
Maltese: Zubsolv jintuża fl-adulti u l-adolexxenti li jkollhom aktar minn 15-il sena, li jkun qed jirċievu wkoll sapport mediku, soċjali u psikoloġiku.
English: EU/1/17/1233/004 EU/1/17/1233/013 EU/1/17/1233/014
Maltese: EU/1/17/1233/011 EU/1/17/1233/012 EU/1/17/1233/013 EU/1/17/1233/014
English: Pruritus Rash Urticaria
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: • rapid or slow heartbeat, myocardial infarction (heart attack), palpitations, chest tightness
Maltese: • taħbit tal-qalb mgħaġġel jew bil-mod, infart mijokardijaku (attakk tal-qalb), palpitazzjonijiet,
English: Reproduction studies by oral administration of buprenorphine: naloxone (ratio 1:1) indicated that embryolethality occurred in rats in the presence of maternal toxicity at all doses.
Maltese: naloxone (proporzjon 1:1) indikaw li lembrijoletalità seħħet fil-firien fil-preżenza ta' tossiċità fl-omm fid-dożi kollha.
English: On Day 3, those randomised to receive buprenorphine/naloxone were switched to the combination tablet.
Maltese: F'Jum 3, dawk li ntgħażlu b'mod każwali biex jirċievu buprenorphine/naloxone, inqalbu għall-pillola kombinata.
English: Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of buprenorphine/naloxone sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment.
Maltese: Tabella 3 turi fil-qosor ir-riżultati minn prova klinika li fiha l-esponiment wara l-għoti ta' doża waħda ta' pillola buprenorphine/naloxone għal taħt l-ilsien, ġiet determinata f'individwi b'saħħithom, u f'individwi b'indeboliment tal-fwied.
English: The long half-life of methadone should be considered when starting buprenorphine/naloxone.
Maltese: Il-half-life twila ta' methadone għandha tiġi kkunsidrata meta tibda buprenorphine/naloxone.
English: Buprenorphine, when taken orally, undergoes first-pass metabolism with N-dealkylation and glucuroconjugation in the small intestine and the liver.
Maltese: Buprenorphine, meta jittieħed b'mod orali, jgħaddi minn metaboliżmu first pass b'N-dealkalizzazzjoni u glukurkonjugazzjoni fil-musrana ż-żgħira u l-fwied.
English: For subjects randomised to either active treatment, dosing began with 8 mg of buprenorphine on Day 1, followed by 16 mg (two 8 mg) of buprenorphine on Day 2.
Maltese: Għall-pazjenti li ntgħażlu b'mod każwali għal xi wieħed miż-żewġ trattamenti attivi, id-dożaġġ beda bi 8 mg ta' buprenorphine f'Jum 1, segwit minn 16 mg (żewġ pilloli ta' 8 mg) ta' buprenorphine f'Jum 2.
English: Dosage adjustment and maintenance therapy
Maltese: Aġġustament tad-doża u terapija ta' manteniment:
English: Use of an opioid antagonist (i.e., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.
Maltese: Hu rakkomandat l-użu ta' antagonist tal-opjojdi (i.e. naloxone), minkejja l-effett modest li jista' jkollu biex ireġġa' lura s-sintomi respiratorji ta' buprenorphine meta mqabbel ma l-effetti tiegħu fuq sustanzi li huma agonisti kompleti tal-opjojdi.
English: It is unknown whether naloxone/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk naloxone/metaboliti jiġux eliminati millħalib tas-sider tal-bniedem.
English: • Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain and other mental disorders.
Maltese: • Mediċini oħrajn li jistgħu jqabbduk in-ngħas li jintużaw għall-kura ta' mard bħalma huma lansjetà, nuqqas ta' rqad, konvulsjonijiet/aċċessjonijiet, uġigħ u disturbi mentali oħrajn.
English: Teva Gyógyszergyár Zrt.
Maltese: Magyarország Teva Gyógyszergyár Zrt.
English: Anti-doping test
Maltese: Testijiet anti-doping
English: Ísland ratiopharm Oy Finnland
Maltese: Ísland ratiopharm Oy
English: Pregelatinized starch (maize) Poloxamer 188
Maltese: Pregelatinized starch (qamħirrun) Poloxamer 188
English: Metabolic and endocrine effects
Maltese: Effetti metaboliċi u endokrinali
English: Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 26 Novembru 2009 Data tal-aħħar reviżjoni: 11 Novembru 2014
English: UAB Sicor Biotech filiāle Latvijā
Maltese: Latvija UAB Sicor Biotech filiāle Latvijā
English: Limit in ppm in API
Maltese: Limitu f'ppm fl-API
English: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Maltese: Teva Pharmaceutical Works Private Limited Company
English: The volume of distribution for irbesartan is 53-93 litres.
Maltese: Il-volum ta' distribuzzjoni għal irbesartan huwa 53-93 litru.
English: Indigotine (Indigo carmine aluminium lake FD&C blue #2) Iron Oxide Black
Maltese: Indigotine (Indigo carmine aluminium lake FD&C blue #2)
English: Gastrointestinal disorders:
Maltese: Disturbi gastrointestinali:
English: Nederland
Maltese: The Netherlands
English: The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age.
Maltese: L-età medja kienet ta' 52.5 sena, 13 % kienu ≥ 65 sena, u 2 % biss kienu ≥ 75 sena.
English: 300 mg/25 mg strength:
Maltese: 300 mg/25 mg:
English: 2031 GA Haarlem The Netherlands
Maltese: 2031 GA Haarlem
English: Primary aldosteronism
Maltese: Aldosteroniżmu primarju
English: 2031GA Haarlem The Netherlands
Maltese: 2031GA Haarlem
English: Drug substance
Maltese: Sustanza mediċinali
English: Respiratory distress (including pneumonitis and pulmonary oedema)
Maltese: Diffikultà respiratorja (li tinkludi pnewmonite u edem pulmonari)
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS)
English: • slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit);
Maltese: • tnaqqis żgħir fil-parametri ta' l-eritroċiti (eritroċiti, emoglobina, ematokrit);
English: The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Maltese: 157-176 u 3.0-3.5 ml/min, rispettivament.