FrancophonIA/ELRC3.0 huggingface dataset:
English: • The correct dose will be calculated by your doctor and consists of a total of 6 mg of asfotase alfa per kg of body weight every week, administered by injection under the skin (subcutaneous), (see the dosing chart below for detailed information on the volume to be injected, and the type of vials to be used, based on your weight).
Maltese: • Id-doża korretta għandha tiġi kkalkulata mit-tabib tiegħek u tikkonsisti minn total ta' 6 mg ta' asfotase alfa għal kull kg ta' piż tal-ġisem kull ġimgħa, mogħtija permezz ta' injezzjoni taħt il-ġilda (subkutanea), (ara t-tabella tad-dożaġġ hawn taħt għal informazzjoni dettaljata dwar il-volum li għandu jiġi injettat, u t-tip ta' kunjetti li għandhom jintużaw, skont il-piż tiegħek).
English: • Hypersensitivity reactions have been observed in patients treated with Strensiq, including a description of sign and symptoms
Maltese: • Reazzjonijiet ta' sensittività eċċessiva ġew osservati f'pazjenti ttrattati bi Strensiq, li jinkludu deskrizzjoni tas-sinjali u s-sintomi
English: Stretched skin, skin discolouration Feeling sick (nausea), numbness of the mouth (hypoaesthesia oral) Aching muscles (myalgia)
Maltese: Ġilda mġebbda, tibdil fil-kulur tal-ġilda Tħossok imdardar (nawseja), tmewwit tal-ħalq (ipoestesija orali) Uġigħ fil-muskoli (mijalġija)
English: Age at inclusion in the study was between 6 and 12 years old and was between 10 and 18 years old at completion, with 9 patients who became between 13 and 17 years old during the study.
Maltese: L-età fl-inklużjoni fl-istudju kienet ta' bejn 6 u 12-il sena u kienet bejn 10 u 18il sena fit-tmiem tal-istudju, b'9 pazjenti li laħqu l-età bejn 13 u 17-il sena matul l-istudju.
English: Each vial of 0.45 ml solution (40 mg/ml) contains 18 mg of asfotase alfa.
Maltese: Kull kunjett ta' 0.45 ml ta' soluzzjoni (40 mg/ml) fih 18 mg ta' asfotase alfa.
English: 1 vial of 0.3[0.45; 0.7; 1] ml 12 vials of 0.3[0.45; 0.7; 1] ml
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 1 kunjett ta' 0.3[0.45; 0.7; 1] ml 12-il kunjett ta' 0.3[0.45; 0.7; 1] ml
English: Twenty five percent (15 out of 60) of the overall patient population was adult (>18 years) at baseline.
Maltese: Ħamsa u għoxrin fil-mija (15 minn 60) tal-popolazzjoni totali tal-pazjenti kienet adulta (>18-il sena) fillinja bażi.
English: Improvements in median RGI-C were maintained over the course of treatment, which ranged from 0.9 to 302.3 weeks, even if fewer patients were followed after Week 96 (a total of 29 patients were followed after Week 96 and ≤8 patients after Week 192).
Maltese: Titjib fir-RGI-C medjan kien miżmum matul iż-żmien tal-kura, li kien ivarja minn 0.9 sa 302.3 ġimgħat, anki jekk kien hemm inqas pazjenti li ġew segwiti wara Ġimgħa 96 (total ta' 29 pazjent kienu segwiti wara Ġimgħa 96 u ≤8 pazjenti wara Ġimgħa 192).
English: Each vial of 0.7 ml solution (40 mg/ml) contains 28 mg of asfotase alfa.
Maltese: Kull kunjett ta' 0.7 ml ta' soluzzjoni (40 mg/ml) fih 28 mg ta' asfotase alfa.
English: • Warning and precautions on the potential risk of medication errors and injection site reactions associated with the use of Strensiq
Maltese: • Twissija u prekawzjonijiet dwar ir-riskju potenzjali ta' żbalji tal-medikazzjoni u reazzjonijiet fis-sit ta' injezzjoni assoċjati mal-użu ta' Strensiq
English: Thirty-eight patients were treated for at least 2 years (24 months) and 6 patients have been treated for at least 5 years (60 months).
Maltese: Tmienja u tletin pazjent kienu kkurati għal mill-inqas sentejn (24 xahar) u 6 pazjenti kienu kkurati għal mill-inqas 5 snin (60 xahar).
English: PHARMACEUTICAL FORM Solution for injection (injection).
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-injezzjoni (injezzjoni).
English: Each vial of 0.3 ml solution (40 mg/ml) contains 12 mg of asfotase alfa.
Maltese: Kull kunjett ta' 0.3 ml ta' soluzzjoni (40 mg/ml) fih 12 mg ta' asfotase alfa.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC {number}
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li gejjin:
English: These have been generally assessed as non-serious, mild to moderate in severity and self-limiting.
Maltese: Dawn ġew ġeneralment evalwati bħala mhux serji, minn ħfief sa moderati fis-severità tagħhom u li jillimitaw lilhom infushom.
English: How to inject Strensiq:
Maltese: Kif għandek tinjetta Strensiq:
English: • Risk management plan (RMP) The marketing authorisation holder (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: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Dietary supervision is recommended.
Maltese: Superviżjoni djetetika hi rakkomandata.
English: Dose - and time-dependent acute injection reactions that were transient and self-limiting were noted in rats at intravenous use doses of 1 to 180 mg/kg.
Maltese: Reazzjonijiet akuti tal-injezzjoni dipendenti mid-doża u miż-żmien, li kienu temporanji u li jillimitaw lilhom infushom, ġew osservati fil-firien f'dożi ġol-vini ta' 1 sa 180 mg/kg.
English: • Patients receiving asfotase alfa have had allergic reactions including life threatening allergic reactions requiring medical treatment similar to anaphylaxis.
Maltese: • Pazjenti li kienu qed jirċievu asfotase alfa kellhom reazzjonijiet allerġiċi, li jinkludu reazzjonijiet allerġiċi ta' theddida għall-ħajja li kienu jeħtieġu trattament mediku simili għal dak tal-anafilassi.
English: Infection of skin at injection site (injection site cellulitis) Reduced levels of calcium in the blood (hypocalcaemia) Kidney stones (nephrolithiasis)
Maltese: Infezzjoni tal-ġilda fis-sit tal-injezzjoni (ċellulite fis-sit tal-injezzjoni) Livelli mnaqqsa ta' kalċju fid-demm (ipokalċimija) Ġebel fil-kliewi (nefrolitijasi)
English: Cohort 1 (n=3) of the study received asfotase alfa 3 mg/kg intravenously the first week followed by 3 doses at 1 mg/kg subcutaneous at weekly intervals from weeks 2 to 4.
Maltese: Koort 1 (n = 3) tal-istudju rċieva asfotase alfa 3 mg/kg ġol-vini flewwel ġimgħa segwit minn 3 dożi ta' 1 mg/kg taħt il-ġilda f'intervalli ta' kull ġimgħa minn ġimgħat 2 sa 4.
English: 12 vials of 0.8 mL
Maltese: 12-il kunjett ta' 0.8 ml
English: Green
Maltese: Deni
English: Severe or potentially life-threatening hypersensitivity is a contraindication to re-challenge, if hypersensitivity is not controllable (see section 4.3).
Maltese: Sensittività eċċessiva severa jew potenzjalment ta' theddida għall-ħajja hi kontraindikazzjoni għal rechallenge, jekk is-sensittività ma tkunx kontrollabbli (ara sezzjoni 4.3).
English: It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa.
Maltese: Hu rakkomandat li l-ormon paratirojde fis-serum u l-calcium jiġu mmonitorjati f'pazjenti ttrattati b'asfotase alfa.
English: Injections sites should be rotated and carefully monitored for signs of potential reactions (see section 4.4).
Maltese: Is-siti tal-injezzjonijiet għandhom jinbidlu u jiġu mmonitorjati b'attenzjoni għal sinjali ta' reazzjonijiet potenzjali (ara sezzjoni 4.4).
English: • Localized lipodystrophy (fatty lumps or deceased fatty tissue on the surface of the skin) have been reported at injection sites after several months in patients using Strensiq.
Maltese: • Lipodistrofija lokalizzata (għoqod tax-xaħam jew tnaqqis tat-tessut xaħmi fil-wiċċ tal-ġilda) ġew irrappurtati fis-siti tal-injezzjoni wara bosta xhur f'pazjenti li kienu qed jużaw Strensiq.
English: Nephrocalcinosis occurred in 51.6% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients.
Maltese: Nefrokalċinożi seħħet f'51.6% tal-pazjenti bejn it-twelid sa meta kellhom 5 snin fi studju ta' storja naturali ta' pazjenti b'ipofosfatasija li bdiet fi żmien it-tfulija, mhux ittrattati.
English: NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection asfotase alfa
Maltese: Strensiq 40 mg/ml soluzzjoni għall-injezzjoni asfotase alfa
English: - Mean (SD) osteoid thickness was 12.8 (3.5) µm at baseline and 9.5 (5.1) µm at week 24
Maltese: - Il-medja (SD) tal-ħxuna tal-ostejojde kienet ta' 12.8(3.5) μm fil-linja bażi u 9.5(5.1) μm f'ġimgħa 24 - Il-medja (SD) tal-volum tal-ostejojde kienet ta' 11.8(5.9)% fil-linja bażi u 8.6(7.2)% f'ġimgħa 24 - Il-medja (SD) tal-lag-time tal-mineralizzazzjoni kienet ta' 93 (70) jum fil-linja bażi u 119-il (225) jum f'ġimgħa 24
English: Strensiq 40 mg/ml solution for injection Filled volumes of the vials are: 0.3 ml, 0.45 ml, 0.7 ml and 1.0 ml
Maltese: Il-volumi mimlija tal-kunjetti huma 0.3 ml, 0.45 ml, 0.7 ml u 1.0 ml Strensiq 100 mg/ml soluzzjoni għall-injezzjoni
English: Use in children and adolescents
Maltese: Pazjenti adulti
English: Contusion
Maltese: Lipodistrofija
English: What is hypophosphatasia
Maltese: X'inhi ipofosfatasija
English: Each vial of 0.8 ml solution (100 mg/ml) contains 80 mg of asfotase alfa.
Maltese: Kull kunjett ta' 0.8 ml ta' soluzzjoni (100 mg/ml) fih 80 mg ta' asfotase alfa.
English: Administration of asfotase alfa may result in local injection site reactions (including, but not limited to, erythema, rash, discoloration, pruritus, pain, papule, nodule, atrophy) defined as any related adverse event occurring during the injection or until the end of the injection day (see section 4.8).
Maltese: L-għoti ta' asfotase alfa jista' jirriżulta f'reazzjonijiet lokali fis-sit tal-injezzjoni (li jinkludu, iżda mhumiex limitati għal, eritema, raxx, tibdil fil-kulur, ħakk, uġigħ, bżieżaq żgħar, għoqda, atrofija) definiti bħala kwalunkwe avveniment avvers relatat li jseħħ matul l-injezzjoni jew sat-tmiem tal-jum tal-injezzjoni (ara sezzjoni 4.8).
English: The majority of the patients who received asfotase alfa moved to scores of +2 and +3 over the first 6 months of exposure and this was sustained with on-going treatment.
Maltese: Il-maġġoranza tal-pazjenti li rċivew asfotase alfa avvanzaw għal punteġġi ta' +2 u +3 matul l-ewwel 6 xhur ta' esponiment, u dan kien sostnut bi trattament li kompla.
English: NAME OF THE MEDICINAL PRODUCT Strensiq 40 mg/ml solution for injection Strensiq 100 mg/ml solution for injection
Maltese: Strensiq 40 mg/ml soluzzjoni għall-injezzjoni Strensiq 100 mg/ml soluzzjoni għall-injezzjoni
English: Ectopic calcifications and injection site reactions were observed in monkeys when asfotase alfa was administered subcutaneously at daily doses up to 10 mg/kg through 26 weeks.
Maltese: Kalċifikazzjonijiet ektopiċi u reazzjonijiet fis-sit tal-injezzjoni ġew osservati fix-xadini meta asfotase alfa ngħata taħt il-ġilda f'dożi ta' kuljum ta' sa 10 mg/kg sa 26 ġimgħa.
English: A few case reports of anaphylactoid/hypersensitivity reaction have also been received and were associated with signs and symptoms of difficulty breathing, choking sensation, periorbital edema and dizziness.
Maltese: Xi ftit rapporti ta' każijiet ta' reazzjoni anafilattojde/ta' sensittività eċċessiva ġew ukoll riċevuti u kienu assoċjati ma' sinjali u sintomi ta' diffikultà biex wieħed jieħu n-nifs, sensazzjoni li wieħed ikun qed jifga, edema periorbitali, u sturdament.
English: Asfotase alfa contains a catalytic domain of tissue non-specific alkaline phosphatase.
Maltese: Strensiq hi mediċina użata biex tittratta l-marda li tintiret tal-ipofosfatasija.
English: Asfotase alfa activity results must not be interpreted as the same measure as serum alkaline phosphatase activity owing to differences in enzyme characteristics.
Maltese: Irriżultati tal-attività ta' asfotase alfa ma jridux jiġu interpretati bħall-istess kejl tal-attività ta' alkaline phosphatase fis-serum minħabba d-differenzi fil-karatteristiċi tal-enzimi.
English: Renal and urinary disorders Common
Maltese: Reazzjoni għall-injezzjoni
English: Some patients confirmed positive for antidrug antibodies experienced injection site reactions (ISRs) and/or hypersensitivity, however there was no consistent trend in the frequency of these reactions over time noted between ADA ever positive and ADA always negative patients.
Maltese: Xi pazjenti kkonfermati pożittivi għal antikorpi kontra l-mediċina esperjenzaw reazzjonijiet fis-sit tal­injezzjoni (ISRs, injection site reactions) u/jew sensittività eċċessiva, madankollu ma ġiet innotata lebda tendenza konsistenti maż-żmien fil-frekwenza ta' dawn ir-reazzjonijiet bejn pazjenti li jkollhom riżultati dejjem pożittivi għal ADA (adenosine deaminase) u l-pazjenti li jkollhom riżultati dejjem negattivi għal ADA.
English: Five out of 7 patients achieved an RGI-C score ≥2 - 5 patients continued with invasive ventilation support, 4 of them with RGI-C score <2 - 3 patients died whilst on ventilation support - 1 patient withdrew consent ∙ 13 patients required non-invasive ventilation support at baseline.
Maltese: - 5 pazjenti komplew b'sapport ta' ventilazzjoni invażiva, 4 minnhom b'punteġġ RGI-C ta' ≤2 - 3 pazjenti mietu waqt li kienu fuq sapport ta' ventilazzjoni - 1 pazjent irtira l-kunsens ∙ 13-il pazjent kienu jeħtieġu sapport b'ventilazzjoni mhux invażiva fil-linja bażi. - 10 pazjenti tneħħew gradwalment minn fuq kwalunkwe sapport b'ventilazzjoni (żmien fuq il-ventilazzjoni minn 3 sa 216-il ġimgħa). 9 minn 10 pazjenti kisbu punteġġ ta' RGI-C ta' ≥2, b'wieħed jew waħda biss ikollhom RGI-C <2. - 2 pazjenti kienu jeħtieġu sapport b'ventilazzjoni invażiv u pazjent wieħed kompla b'sapport b'ventilazzjoni mhux invażiva, it-3 pazjenti kollha mietu u tnejn kellhom punteġġ ta' RGI-C ta' <2
English: If asfotase alfa is present in clinical laboratory samples, aberrant values could be reported.
Maltese: Jekk asfotase alfa jkun preżenti fil-kampjuni kliniċi tal-laboratorju, jistgħu jiġu rrappurtati valuri aberranti.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. the product is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri il-prodott hu essenzjalment ‘ħieles mis-sodium'.
English: Other hypersensitivity reactions included vomiting, nausea, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus, and oral hypaesthesia.
Maltese: Reazzjonijiet oħra ta' sensittività eċċessiva kienu jinkludi rimettar, dardir, deni, uġigħ ta' ras, fwawar, irritabbiltà, tertir ta' bard, eritema tal-ġilda, raxx, ħakk, u ipestesija orali.
English: Important information about some of the ingredients of Strensiq This medicine contains less than 1 mmol sodium (23 mg) per vial, which means it is essentially ‘sodiumfree'.
Maltese: Informazzjoni importanti dwar xi wħud mis-sustanzi ta' Strensiq Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri il-prodott hu essenzjalment ‘ħieles mis-sodium'.
English: There was no evidence of ectopic calcification observed in any other tissues examined.
Maltese: Ma kien hemm ebda evidenza ta' kalċifikazzjoni ektopika osservata fi kwalunkwe tessuti oħrajn eżaminati.
English: 751 05 Uppsala Sweden
Maltese: 751 05 Uppsala
English: • Dependence
Maltese: • Dipendenza
English: Date of first authorisation: 10 November 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10 Novembru 2017
English: Acute alcoholism or delirium tremens.
Maltese: Alkoħoliżmu akut jew delirium tremens.
English: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥/10,000
Maltese: Komuni ħafna (≥1/10); Komuni (≥1/100 sa <1/10); Mhux komuni (≥1/1,000 sa <1/100); Rari (≥1/10,000 sa <1/1,000);
English: CYP 3A inhibitors
Maltese: Inibituri ta' CYP3A
English: Use in adolescents (Age 15 - <18 years)
Maltese: Użu fl-adolexxenti (Età 15 - <18-il sena)
English: Oedema peripheral
Maltese: Edema periferali
English: Absorption and distribution
Maltese: Assorbiment u distribuzzjoni
English: Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes.
Maltese: Id-doża inizjali ta' naloxone tista' tvarja sa 2 mg u tiġi ripetuta kull 2-3 minuti.
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 sommarju tar-reazzjonijiet avversi rrappurtati mill-provi kliniċi importanti ħafna, li fihom 342 minn 472 pazjent (72.5%) irrappurtaw reazzjonijiet avversi, u reazzjonijiet avversi rrappurtati waqt is-sorveljanza ta' wara t-tqegħid fis-suq.
English: Pack-size of 30 (3 x 10) tablets.
Maltese: Daqs tal-pakkett ta' 30 (3 x 10) pillola.
English: Angina Pectoris Bradycardia Myocardial infarction Palpitations Tachycardia
Maltese: Anġina Pectoris Bradikardija Infart mijokardijaku Palpitazzjonijiet Takikardija
English: • Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam.
Maltese: • Benzodiazepines (jintużaw biex jittrattaw l-ansjetà jew disturbi fl-irqad) diazepam, temazepam, alprazolam.
English: Pack-size of 7 (1 x 7) tablets.
Maltese: Daqs tal-pakkett ta' 7 (1 x 7) pillola.
English: The maximum daily dose is 17.2 mg.
Maltese: Id-doża massima ta' kuljum hi ta' 17.2 mg.
English: The other ingredients are mannitol, citric acid anhydrous, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica and sodium stearyl fumarate.
Maltese: Is-sustanzi mhux attivi l-oħra huma mannitol, citric acid anhydrous, sodium citrate, microcrystalline cellulose, croscarmellose sodium, sucralose, levomenthol, colloidal anhydrous silica u sodium stearyl fumarate.
English: • amnesia (memory disturbance), convulsion (fits), speech disorder, tremor
Maltese: • amnesija (disturb fil-memorja), konvulżjonijiet (aċċessjonijiet), disturbi fit-taħdit, rogħda
English: Pack-size of 28 (4 x 7) tablets.
Maltese: Daqs tal-pakkett ta' 28 (4 x 7) pillola.
English: Bronchospasm Respiratory depression
Maltese: Bronkospażm u Tnaqqis respiratorju
English: Arthritis
Maltese: Artrite
English: Severe respiratory insufficiency.
Maltese: Insuffiċjenza respiratorja severa
English: PVC/OPA/Al/PVC // Al/PET/Paper child resistant blister cards.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih kards bil-folji tal-PVC/OPA/Al/PVC//Al/PET/Karta, reżistenti għat-tfal.
English: “11.4” on one side
Maltese: “11.4” fuq naħa waħda
English: Clinical data confirm that CYP3A4 is responsible for the N-dealkylation of buprenorphine.
Maltese: Dejta klinika tikkonferma li CYP3A4 hu responsabbli għall-N-dealkalizzazzjoni ta' buprenorphine.
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 beninni taċ-ċelluli interstizjali (ta' Leydig) tat-testikoli, ġew osservati fil-gruppi kollha tad-dożaġġ.
English: Opioid agonist ceiling effects were observed during clinical pharmacology studies in opioid-dependent patients.
Maltese: L-effetti ceiling tal-agonisti tal-opjojdi ġew osservati matul studji farmakoloġiċi kliniċi fuq persuni dipendenti fuq l-opjojdi.
English: Severe Hepatic Impairment (Child-Pugh Class C) (n=8)
Maltese: (Child-Pugh Klassi C) (n=8)
English: System Organ
Maltese: Organi
English: Mild hepatic Impairment (Child-Pugh Class A) (n=9)
Maltese: (Child-Pugħ Klassi A) (n=9)
English: Moderate Hepatic Impairment (Child-Pugh Class B) (n=8)
Maltese: (Child-Pugh Klassi B) (n=8)
English: Table 1: Treatment related adverse reactions reported in clinical trials and post-marketing surveillance of buprenorphine/naloxone
Maltese: Tabella 1: Reazzjonijiet avversi relatati mat-trattament irrappurtati fil-provi kliniċi u fis sorveljanza ta' wara t-tqegħid fis-suq ta' buprenorphine/naloxone Sistema tal
English: Similar to control
Maltese: Simili għall-kontroll
English: Depression Libido decreased Nervousness Thinking abnormal
Maltese: Depressjoni Tnaqqis fil-libido Nervożità Ħsibijiet anormali
English: The percentage of thrice-weekly urine samples that were negative for non-study opioids was statistically higher for both buprenorphine/naloxone versus placebo (p < 0.0001) and buprenorphine versus placebo (p < 0.0001).
Maltese: Il-perċentwali tal-kampjuni tal-awrina li ttieħdu tliet darbiet fil-ġimgħa, li kienu negattivi għall-opjojdi mhux tal-istudju, kien statistikament ogħla kemm għal buprenorphine/naloxone kontra l-plaċebo (p < 0.0001) u buprenorphine kontra l-plaċebo (p < 0.0001).
English: White, D-shaped tablet, height 7.3 mm and width 5.65 mm
Maltese: Pillola bajda b'forma ta' D, b'għoli ta' 7.3 mm u wisa' ta' 5.65 mm
English: Buprenorphine/naloxone is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2).
Maltese: Buprenorphine/naloxone hu kontraindikat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjonijiet 4.3 u 5.2).
English: “8.6” on one side
Maltese: “8.6” fuq naħa waħda
English: 7 sublingual tablets 28 sublingual tablets 30 sublingual tablets
Maltese: 7 pillola għal taħt l-ilsien 28 pillola għal taħt l-ilsien 30 pillola għal taħt l-ilsien
English: White, triangular tablets, base 7.2 mm and height 6.9 mm, debossed with “1.4” on one side.
Maltese: Pilloli bojod, trijangolari, b'bażi 7.2 mm u għoli ta' 6.9 mm, imnaqqxa b'”1.4” fuq naħa waħda.
English: • abnormal dreams, agitation, loss of interest, depersonalisation (not feeling like yourself),
Maltese: • ħolm mhux normali, aġitazzjoni, telf ta' interess, depersonalizzazzjoni (ma tħossokx li int inti),
English: Respiratory depression
Maltese: Tnaqqis respiratorju
English: Depersonalisation Drug dependence Euphoric mood Hostility
Maltese: Depersonalizzazzjoni Dipendenza fuq iddroga
English: • 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: • depressanti oħrajn tas-sistema nervuża ċentrali, derivattivi oħrajn tal-opjojdi (eż. methadone, analġeżiċi u mediċini kontra s-sogħla), ċerti mediċini kontra d-depressjoni, antagonisti sedattivi tar-riċettur-H1, barbiturates, anxiolytics li mhumiex benzodiazepines, newrolettiċi, clonidine u sustanzi relatati: dawn il-kombinazzjonijiet iżidu t-tnaqqis tas-sistema nervuża ċentrali.
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 mgħaġġla ta' distribuzzjoni (half-life taddistribuzzjoni ta' 2 sa 5 sigħat).
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 sigħat.
English: Zubsolv contains the active substances buprenorphine and naloxone.
Maltese: Zubsolv fiha is-sustanzi attivi buprenorphine u naloxone.
English: Zubsolv is not interchangeable with other buprenorphine products, as different buprenorphine products have different bioavailability.
Maltese: Zubsolv ma jistax jinbidel ma' prodotti oħra li fihom buprenorphine, għax prodotti differenti li fihom buprenorphine għandhom bijodisponibilità differenti.
English: Elderly No pharmacokinetic data in elderly patients are available.
Maltese: M'hemm l-ebda dejta farmakokinetika f'pazjenti anzjani disponibbli.