FrancophonIA/ELRC3.0 huggingface dataset:
English: Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes.
Maltese: Id-dapagliflożina flimkien mal-metformina kienet evalwata f'6 studji ewlenin li kienu jinvolvu 3,200 adult bid-dijabete tat-tip 2.
English: • patients with diabetic precoma (a dangerous condition that can occur in diabetes);
Maltese: • f'pazjenti li jbatu minn prekoma dijabetika (kondizzjoni perikoluża li tista' sseħħ fid-dijabete);
English: The most common side effects with Xigduo (which may affect more than 1 in 10 people) are hypoglycaemia (when used together with insulin or a sulphonylurea) and gastrointestinal symptoms (symptoms affecting the stomach and gut).
Maltese: L-effetti sekondarji l-aktar komuni b'Xigduo (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma ipogliċemija (meta jintuża flimkien mal-insulina jew ma' sulfonilurea) u sintomi gastrointestinali (sintomi li jaffettwaw l-istonku u l-imsaren).
English: Regarding its safety profile, this was considered similar to the safety profile of dapagliflozin.
Maltese: Fir-rigward tal-profil tas-sigurtà tiegħu, dan tqies simili għall-profil tas-sigurtà tad-dapagliflożina.
English: As for all medicines, data on the use of Xigduo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Xigduo hija ssorveljata kontinwament.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Maltese: Studju fit-tul, li kien jinvolvi iktar minn 17 000 pazjent bid-dijabete tat-tip 2, ħares lejn l-effetti taddapagliflożina fuq il-mard kardjovaskulari (il-qalb u ċ-ċirkolazzjoni).
English: HbA1c (glycosylated haemoglobin) is a substance in the blood which gives an indication of how well the blood glucose is controlled.
Maltese: HbA1c (emoglobina glikosilata) hija sustanza fid-demm li tagħti indikazzjoni ta' kemm ilglukożju fid-demm ikun ikkontrollat.
English: Xigduo is a diabetes medicine used, together with diet and exercise in adults with type 2 diabetes.
Maltese: Xigduo huwa mediċina tad-dijabete użata flimkien ma' dieta u eżerċizzju f'adulti bid-dijabite tat-tip 2.
English: How is Xigduo used?
Maltese: Kif jaħdem Xigduo?
English: The majority of these data had already been used in the authorisation of Forxiga.
Maltese: Il-maġġoranza ta' din id-data kienet diġà ntużat fl-awtorizzazzjoni ta' Forxiga.
English: Xigduo (dapagliflozin / metformin)
Maltese: Xigduo m'għandux jintuża:
English: For the full list of side effects of Xigduo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Xigduo, ara l-fuljett ta' tagħrif.
English: When Xigduo is added to treatment with insulin or a medicine that helps the body to produce insulin, such as a sulphonylurea, the doctor may need to lower the dose of insulin or sulphonylurea to prevent hypoglycaemia (low blood sugar levels).
Maltese: Meta Xigduo jiżdied ma' kura bl-insulina jew mediċina li tgħin lill-ġisem jipproduċi l-insulina, bħal sulfonilurea, it-tabib jista' jkollu bżonn inaqqas id-doża tal-insulina jew tas-sulfonilurea għallprevenzjoni ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: • metformin works mainly by reducing glucose production and reducing its absorption from the gut.
Maltese: • il-metformina taħdem prinċipalment billi tnaqqas il-produzzjoni ta' glukożju u tnaqqas lassorbiment tiegħu fl-imsaren.
English: • in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Maltese: • flimkien ma' mediċini oħra tad-dijabete meta dawn il-mediċini flimkien mal-metformina ma jkunux qed jikkontrollow id-dijabete b'mod sodisfaċenti.
English: België/Belgique/Belgien Luxemburg/Luxembourg S.A. Grünenthal N.V.
Maltese: België/Belgique/Belgien Luxembourg/Luxemburg S.A. Grünenthal N.V.
English: Patients with BMI > 30 kg/m
Maltese: Pazjenti b'BMI > 30 kg/m
English: Grünenthal Norway AS C.J. Hambros Plass 2C 0164 Oslo
Maltese: Grünenthal Norway AS C.J. Hambros Plass 2C 0164
English: Immeuble Eurêka 19 rue Ernest Renan CS 90001
Maltese: Laboratoires Grünenthal SAS Immeuble Eurêka 19 rue Ernest Renan CS 90001
English: Local tolerance
Maltese: Tolleranza lokali
English: Respiratory depression
Maltese: Depressjoni respiratorja
English: 52078 Aachen Germany
Maltese: 52078 Aachen
English: Date of first authorisation: 18 September 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 18 Settembru 2015
English: F- 92024 Nanterre Cedex Tél: + 33 (0)1 41 49 45 80
Maltese: Nanterre Cedex Tél: + 33 (0)1 41 49 45 80
English: Sufentanil may produce bradycardia.
Maltese: Sufentanil jista' jikkawża bradikardija.
English: The Ames test revealed no mutagenic activity of sufentanil.
Maltese: It-test Ames ma żvela l-ebda attività mutaġenika ta' sufentanil.
English: ≥1/10,000 and <1/1,000
Maltese: ≥ 1/10,000 u < 1/1,000
English: Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazol, ritonavir) cannot be excluded.
Maltese: Effetti simili b'inibituri ta' CYP3A4 b'saħħithom oħra (eż. itraconazol, ritonavir) ma jistgħux jiġu esklużi.
English: Zamenhof, 36 E-28027 Madrid Tel: +34 (91) 301 93 00
Maltese: Grünenthal Pharma, S.A. C/Dr. Zamenhof, 36 E-28027 Madrid Tel: +34 (91) 301 93 00
English: Central nervous system (CNS) depressants
Maltese: Mediċini kontra d-depressjoni tas-sistema nervuża ċentrali (CNS)
English: Somnolence Paraesthesia Ataxia* Dystonia* Hyperreflexia*
Maltese: Atassja b'Paraesteżija* Distonja* Iperrefleksja*
English: * see “Description of selected adverse reactions”
Maltese: * ara “Deskrizzjoni ta' reazzjonijiet avversi magħżula”
English: - Medicines for the treatment of depression known as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
Maltese: - Mediċini għall-kura tad-depressjoni magħrufin bħala Inibituri ta' Teħid mill-Ġdid ta' Serotonin Selettivi (SSRIs, Selective Serotonin Reuptake Inhibitors) u Inibituri ta' Teħid mill-Ġdid ta' Serotonin Norepinephrine (SNRIs, Serotonin Norepinephrine Reuptake Inhibitors).
English: EXP see page 1 EXP see reverse
Maltese: EXP ara paġna 1 EXP ara fuq wara
English: Annex IV
Maltese: ANNESS IV
English: ≥1/100 and <1/10
Maltese: ≥ 1/100 u < 1/10≥ 1/10
English: Confusional state Apathy* Nervousness*
Maltese: Apatija* Tħossok nervuż*
English: OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY
Maltese: TIKKETTA TA' BARRA (BIL-BLUE BOX) PAKKETTI MULTIPLI BISS
English: Apnoea
Maltese: Apneja
English: Each sublingual tablet contains 0.013 mg sodium.
Maltese: Kull pillola għal taħt l-ilsien fiha 0.013 mg sodium.
English: - Medicines for the treatment of depression known as Monoamine Oxidase Inhibitors (MAOIs).
Maltese: Mediċini għall-kura tad-depressjoni magħrufin bħala Inibituri tal-Monoamine Oxidase (MAOIs, Monoamine Oxidase Inhibitors).
English: Zalviso 15 micrograms sublingual tablets Sufentanil
Maltese: Zalviso 15-il mikrogramma pilloli għal taħt l-ilsien Sufentanil
English: Alameda Fernão Lopes, 12-8.º A P-1495 - 190 Algés Tel: +351 / 214 72 63 00
Maltese: Alameda Fernão Lopes, 12-8.º A P-1495 - 190
English: Ketoconazole, a potent CYP3A4 inhibitor, can significantly increase the systemic exposure to sublingual sufentanil (maximal plasma levels (Cmax) increase of 19 %, overall exposure to the active substance (AUC) increase of 77 %) and prolong the time to reach maximum concentration by 41 %.
Maltese: Ketoconazole, inibitur qawwi ta' CYP3A4, jista' jżid b'mod sinifikanti l-esponiment sistematiku għal sufentanil għal taħt l-ilsien (żieda fil-livelli massimi fil-plażma (Cmax) b'19%, żieda fl-esponiment globali għas-sustanza attiva (AUC) ta' 77%) u jdewwem iż-żmien sakemm tintlaħaq il-konċentrazzjoni massima b'41%.
English: Muscle twitching*
Maltese: Ħalq xott*
English: Very common ≥1/10 Common
Maltese: Komuni ħafna ≥ 1/10
English: Efficacy of Zalviso for patient-controlled analgesia was demonstrated in 3 Phase III clinical trials in acute post-surgical nociceptive and visceral pain (post-surgical pain following major abdominal or orthopaedic surgery): 2 trials were double-blind placebo-controlled (Zalviso N = 430 patients; placebo N = 161 patients) and 1 was an open-label active-controlled (Zalviso N = 177 patients; morphine N = 180 patients) trial.
Maltese: 2 provi kienu double-blind ikkontrollati bi plaċebo (Zalviso N = 430 pazjent; plaċebo N = 161 pazjent) u 1 kienet prova b'tikketta mikxufa kkontrollata attivament (Zalviso N = 177 pazjent; morfina N = 180 pazjent).
English: Gastrointestinal effects of sufentanil comprise decreased propulsive motility, reduced secretion and increased muscle tone (up to spasms) of the sphincters of the gastrointestinal tract (see section 4.4).
Maltese: L-effetti gastro-intestinali ta' sufentanil jinkludu tnaqqis fil-motilità propulsiva, tnaqqis fis-sekrezzjoni u żieda fit-ton tal-muskoli (sa spażmi) tal-isfinteri tal-passaġġ gastro-intestinali (ara sezzjoni 4.4).
English: Hyperhidrosis Rash
Maltese: Iperidrożi Raxx
English: The safety and efficacy in elderly patients was similar to that observed in younger adults (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja f'pazjenti anzjani kienu simili għal dawk osservati f'adulti iżgħar (ara sezzjoni 5.2).
English: Gastrointestinal effects
Maltese: Effetti gastro-intestinali
English: What Zalviso contains - The active substance is sufentanil.
Maltese: X'fih Zalviso - Is-sustanza attiva hija sufentanil.
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Maltese: Sufentanil jista' jikkawża depressjoni respiratorja, li l-livell/severità tagħha hija relatata mad-doża.
English: In clinical trials approximately 30 % of enrolled patients were 65 to 75 years of age.
Maltese: Fi provi kliniċi madwar 30% tal-pazjenti li pparteċipaw kellhom minn 65 sa 75 sena.
English: Population pharmacokinetics
Maltese: Farmakokinetika tal-popolazzjoni
English: Serotonergic agents
Maltese: Sustanzi serotonerġiiċi
English: Repeat-dose toxicity
Maltese: Effett tossiku minn dożi ripetuti
English: Direct effects of sufentanil on myocardial function were not observed.
Maltese: Effetti diretti ta' sufentanil fuq il-funzjoni mijokardijaka ma ġewx osservati.
English: Analgesic doses of Zalviso resulted in respiratory depressive effects in some patients in the clinical trials.
Maltese: Fil-provi kliniċi dożi analġeżiċi ta' Zalviso rriżultaw f'effetti respiratorji depressivi f'ċerti pazjenti.
English: Zalviso 15 micrograms sublingual tablets
Maltese: Zalviso 15-il mikrogramma pilloli għal taħt l-ilsien
English: Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium Lake (E110).
Maltese: Kull pillola għal taħt l-ilsien fiha 0.074 mg sunset yellow FCF Aluminium Lake (E110).
English: Grünenthal Denmark ApS Arne Jacobsens Allé 7 2300 København S Tlf: +45 88883200
Maltese: Grünenthal Denmark ApS Arne Jacobsens Allé 7 2300
English: INTERMEDIATE CARTON COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Maltese: IL-KARTUNA TAN-NOFS TA' PAKKETT MULTIPLU (MINGĦAJR BLUE BOX)
English: The total plasma clearance after single intravenous administration is about 917 l/min.
Maltese: It-tneħħija totali mill-plażma wara għoti ta' darba ġol-vini hija ta' madwar 917 l/min.
English: EU/1/15/1042/001 1 cartridge of 40 sublingual tablets EU/1/15/1042/002 10 cartridges of 40 sublingual tablets each EU/1/15/1042/003 20 cartridges of 40 sublingual tablets each
Maltese: EU/1/15/1042/001 1 stoċċ ta' 40 pillola għal taħt l-ilsien EU/1/15/1042/002 10 stoċċijiet ta' 40 pillola għal taħt l-ilsien kull wieħed EU/1/15/1042/003 20 stoċċ ta' 40 pillola għal taħt l-ilsien kull wieħed
English: 1932 Sint-Stevens-Woluwe België/Belgique/Belgien Tél/Tel: + 32 (0)2 290 52 00 beinfo@grunenthal.com
Maltese: Tél/Tel: + 32 (0)2 290 52 00 beinfo@grunenthal.com
English: However, there was a statistically significant lower percentage of patients who experienced oxygen desaturation episodes following the administration of Zalviso sublingual tablets (19.8 %) with the administration device than in the IV PCA morphine group (30.0 %).
Maltese: Madankollu, kien hemm perċentwal statistikament sinifikanti u aktar baxx ta' pazjenti li kellhom episodji ta' desaturazzjoni tal-ossiġnu wara l-għoti ta' Zalviso pilloli għal taħt l-ilsien (19.8%) bl-apparat tal-għoti mill-grupp tal-morfina IV PCA (30.0%).
English: Co-administration of sufentanil with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), or Monoamine Oxidase Inhibitors (MAOIs), may increase the risk of serotonin syndrome, a potentially life threatening condition.
Maltese: L-għoti fl-istess ħin ta' sufentanil ma' sustanza serotonerġika, bħal Inibituri ta' Teħid mill-Ġdid ta' Serotonin Selettivi (SSRIs, Selective Serotonin Reuptake Inhibitors), Inibituri ta' Teħid mill-Ġdid ta' Serotonin Norepinephrine (SNRIs, Serotonin Norepinephrine Reuptake Inhibitors) jew Inibituri talMonoamine Oxidase (MAOIs, Monoamine Oxidase Inhibitors), jista' jżid ir-riskju tas-sindrome ta' serotonin, kundizzjoni li potenzjalment hija ta' theddida għall-ħajjja.
English: OUTER CARTON for 1, 10 and 20 cartridges
Maltese: KARTUNA TA' BARRA għal stoċċ 1, 10 u 20 stoċċijiet
English: - The other ingredients are mannitol (E421), calcium hydrogen phosphate (anhydrous), hypromellose, croscarmellose sodium, stearic acid, magnesium stearate, sunset yellow FCF Aluminium Lake (E110) (see section 2 “What you need to know before you take Zalviso”)
Maltese: Kull pillola għal taħt l-ilsien fiha 15-il mikrogramma sufentanil (bħala ċitrat) - Is-sustanzi l-oħra huma mannitol (E421), calcium hydrogen phosphate (anhydrous), hypromellose, croscarmellose sodium, stearic acid, magnesium stearate, sunset yellow FCF Aluminium Lake (E110) (ara sezzjoni 2 “X'għandek tkun taf qabel ma tieħu Zalviso”)
English: Miosis disturbances
Maltese: Disturbi vaskulari
English: Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances
Maltese: Riskju minn użu konkomitanti ta' prodotti mediċinali ta' sedazzjoni bħal benzodiazepines jew sustanzi relatati
English: In clinical trials during repeated administrations the bioavailability decreased to 37.6 %.
Maltese: Fil-provi kliniċi matul l-għoti ripetut il-bijodisponibbiltà naqqset għal 37.6%.
English: A significantly higher proportion of patients (78.5 %) rated the method of pain control as “good” or “excellent” with Zalviso than with intravenous morphine patient-controlled analgesia method (65.5 %) (primary endpoint at 48 hours; P = 0.007).
Maltese: Proporzjon sinifikanti ogħla ta' pazjenti (78.5%) ikklassifikaw il-metodu ta' kontroll tal-uġigħ bħala “tajjeb” jew “eċċellenti” b'Zalviso meta mqabbel mal-metodu ta' analġeżija bil-morfina kkontrollata mill-pazjent (65.5%) (punt ta' tmiem primarju fi 48 siegħa; P = 0.007).
English: Contains sunset yellow FCF Aluminium Lake (E110), contains sodium.
Maltese: Fih sunset yellow FCF Aluminium Lake (E110), fih sodium.
English: Uncommon ≥1/1,000 and <1/100 Rare
Maltese: ≥ 1/1,000 u < 1/100
English: EU/1/15/1042/004 2 x 20 cartridges of 40 sublingual tablets each EU/1/15/1042/005 3 x 20 cartridges of 40 sublingual tablets each EU/1/15/1042/006 5 x 20 cartridges of 40 sublingual tablets each
Maltese: 2 x 20 stoċċ ta' 40 pillola għal taħt l-ilsien kull wieħed EU/1/15/1042/005 3 x 20 stoċċ ta' 40 pillola għal taħt l-ilsien kull wieħed EU/1/15/1042/006 5 x 20 stoċċ ta' 40 pillola ta' taħt l-ilsien kull wieħed
English: Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme.
Maltese: Sufentanil huwa metabolizzat prinċipalment mill-enzima tal-bniedem ċitokromu P450-3A4.
English: Patients reported in all the 3 Phase III trials a clinically meaningful pain relief within the first hour of treatment with Zalviso (pain intensity difference to baseline and total pain response >1 NRS).
Maltese: III kollha l-pazjenti rrapportaw tnaqqis b'rilevanza klinika tal-uġigħ fl-ewwel siegħa ta' kura b'Zalviso (differenza fl-intensità tal-uġigħ għal-linja bażi u rispons totali għall-uġigħ > 1 NRS).
English: Mean absolute bioavailability after a single sublingual administration of Zalviso relative to a oneminute intravenous sufentanil infusion of 15 micrograms was 59 %.
Maltese: Il-bijodisponibbiltà assoluta medja wara l-għoti uniku taħt l-ilsien ta' Zalviso relattiv għal infużjoni ta' 15-il mikrogramma sufentanil ġol-vini għal minuta waħda kienet ta' 59%.
English: Only 2 % of the dose is excreted in unchanged form.
Maltese: Huwa biss 2% tad-doża li jiġi eliminat f'forma mhux mibdula.
English: Prior to launch of Zalviso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Zalviso f'kull Stat Membru d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (Marketing Authorization Holder, MAH) għandu jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi midja ta' kommunikazzjoni, modalitajiet ta' distribuzzjoni u kull aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: Population pharmacokinetic analysis with a BMI as covariate showed that patients with a BMI > 30 kg/m2 dosed more frequently.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni b'BMI bħala kovarjant tissuġġerixxi li pazjenti li għandhom BMI > 30 kg/m2 ħadu doża aktar frekwentement.
English: Therefore, Zalviso should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Maltese: Għalhekk, Zalviso għandu jintuża b'kawtela f'pazjenti b'mard fl-apparat biljari, inkluż pankreatite akuta.
English: Campus 21, Liebermannstraße A01/501 2345 Brunn am Gebirge Tel: +43(0)2236 379 550-0
Maltese: Campus 21, Liebermannstraße A01/501 2345
English: Concomitant use of Zalviso and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.
Maltese: Użu konkomitanti ta' Zalviso u prodotti mediċinali ta' sedazzjoni bħal benzodiazepines jew sustanzi relatati jista' jirriżulta f'sedazzjoni, depressjoni respiratorja, koma u mewt.
English: Clinically relevant plasma levels are largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50 % of Cmax after discontinuation of dosing (context sensitive halftime or CST½) rather than by the terminal half-life.
Maltese: Il-livelli fil-plażma klinikament rilevanti huma determinati l-aktar mill-ħin meħtieġ biex il-konċentrazzjoni fil-plażma ta' sufentanil taqa' minn Cmax għal 50% ta' Cmax wara li t-twaqqif tad-doża (half-time sensittiv għall-kuntest jew CST½) aktar milli permezz tal-half-life terminali.
English: Sufentanil may cause respiratory depression (see section 4.4) and also suppresses the cough reflex.
Maltese: Sufentanil jista' jikkawża depressjoni respiratorja (ara sezzjoni 4.4) kif ukoll irażżan ir-riflessi tas-sogħla.
English: After single administration of a 15 micrograms sufentanil sublingual tablet, mean terminal phase halflives in the range of 6 to 10 hours have been observed.
Maltese: Wara l-għoti ta' darba ta' pillola ta' 15-il migrogramma taħt l-ilsien ta' sufentanil, kienu osservati half-lives terminali medji fil-firxa ta' 6 sa 10 sigħat.
English: Zalviso sublingual tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Maltese: Zalviso fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles missodium'.
English: Pruritus
Maltese: Prurite
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Zalviso is launched all healthcare professionals who are expected to prescribe Zalviso are informed through an information letter on having access to / are provided with the following items:
Maltese: L-MAH għandu jiżgura li, wara diskussjonijiet u ftehim mal-Awtoritajiet Nazzjonali Kompetenti f'kull Stat Membru fejn Zalviso jiġi mniedi l-professjonisti fil-qasam tal-kura tas-saħħa kollha li huma mistennija li jippreskrivu Zalviso jiġu informati permezz ta' ittra ta' informazzjoni biex ikollhom aċċess lil / jiġu provduti bl-oġġetti li ġejjin:
English: Uncommon side effects (may affect up to 1 in 100 people): allergic reactions, lack of interest or emotion, nervousness, sleepiness, abnormal sensation of the skin, problems coordinating muscle movements, muscle contractions, exaggeration of reflexes, vision disturbances, decreased heart rate, dry mouth, excessive sweating, rash, dry skin, chills, weakness.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): reazzjonijiet allerġiċi, nuqqas ta' interess jew emozzjoni, tħossok nervuż, ngħas, sensazzjoni anormali tal-ġilda, problemi bil-koordinazzjoni tal-movimenti tal-muskoli, kontrazzjonijiet fil-muskoli, eżaġerazzjoni fir-riflessi, disturbi fil-vista, tnaqqis fir-ritmu ta' taħbit tal-qalb, ħalq xott, tegħreq ħafna, raxx, ġilda xotta, tertir bil-bard, dgħjufija.
English: Some adverse reactions were not observed in the clinical trials with Zalviso.
Maltese: Ċertu reazzjonijiet avversi ma kinux osservati fil-provi kliniċi b'Zalviso.
English: The central volume of distribution after intravenous application of sufentanil is approximately 14 litres and the volume of distribution at steady state is approximately 350 litres.
Maltese: Il-volum ċentrali tad-distribuzzjoni wara l-applikazzjoni ġol-vini ta' sufentanil huwa ta' madwar 14-il litru u l-volum tad-distribuzzjonii fi stat fiss huwa ta' madwar 350 litru.
English: Similar CST½ values were observed following both single and repeated administration demonstrating that there is a predictable and consistent duration of action after multiple dosing of the sublingual tablet.
Maltese: Valuri CST½ simili kienu osservati kemm wara l-għoti ta' doża waħda kif ukoll ta' dożi ripetuti li juri li hemm dewmien prevedibbli u konsistenti tal-azzjoni wara diversi dożi tal-pillola għal taħt l-ilsien.
English: Sufentanil has been shown to induce opioid-like effects in a variety of laboratory animals (dogs, rats, guinea pigs, hamsters) at doses above those inducing analgesia and in two repeat-dose studies with sufentanil sublingual tablets administered buccally in Golden Syrian hamster.
Maltese: Sufentanil intwera li jinduċi effetti bħal ta' opjojdi f'diversi annimali tal-laboratorju (klieb, firien, fniek tal-Indi, ħamsters) f'dożi ogħla minn dawk li jinduċu analġeżja u f'żewġ studji b'doża ripetuta b'pilloli ta' taħt l-ilsien ta' sufentanil li ngħataw mill-ħalq lil ħamster tat-tip Golden Syrian.
English: Superiority over placebo was demonstrated in the Phase III placebo-controlled trials for the primary endpoint time-weighted sum of pain intensity difference from baseline over 48 hours (SPID48; P 0.001), and the secondary endpoints, time-weighted SPID (P 0.004), total pain relief (TOTPAR; P 0.004), and patients global assessment (P 0.007) over 24, 48 and 72 hours.
Maltese: III għas-somma tal-punt ta' tmiem primarju ppeżata skont il-ħin tad-differenza fl-intensità tal-uġigħ mil-linja bażi fuq 48 siegħa (SPID48; P 0.001), u l-punti ta' tmiem sekondarji, l-SPID ippeżat skont il-ħin (P 0.
English: Frequency not known (frequency cannot be estimated from the available data): severe allergic reactions (anaphylactic shock), convulsion (fits), coma, small pupil size, redness of the skin, withdrawal syndrome.
Maltese: Frekwenza mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): reazzjonijiet allerġiċi severi (xokk anafilattiku), konvulsjoni (aċċessjonijiet), koma, il-ħabba tal-għajn tiċkien, ħmura fil-ġilda, sindrome ta' rtirar.
English: Sedating medicinal products such as benzodiazepines or related substances
Maltese: Prodotti mediċinali ta' sedazzjoni bħal benzodiazepines jew sustanzi relatati