FrancophonIA/ELRC3.0 huggingface dataset:
English: Steglujan was shown to be effective at controlling blood glucose levels.
Maltese: Steglujan intwera li kien effettiv fil-kontroll tal-livelli tal-glukożju fid-demm.
English: How is Steglujan used?
Maltese: Steglujan?
English: Side effects reported with Steglujan are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Steglujan huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Sitagliptin blocks the breakdown of incretin hormones in the body.
Maltese: is-sitagliptin timblokka t-tkissir ta' ormoni ta' inkretin fil-ġisem.
English: 1 g / 0.5 g Powder for concentrate for solution for infusion
Maltese: 1 g / 0.5
English: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, Ireland.
Maltese: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, L-Irlanda.
English: MedDRA system organ class
Maltese: Sistema tal-klassifika tal-organi MedDRA
English: Central nervous system (CNS) depressants
Maltese: Depressanti tas-sistema nervuża ċentrali (CNS)
English: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas Dublin 11 Ireland
Maltese: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas Dublin 11 L-Irlanda
English: Abuse potential and tolerance
Maltese: Abbuż potenzjali u tolleranza
English: Respiratory arrest
Maltese: Arrest respiratorju
English: Gastrointestinal effects
Maltese: Effetti gastrointestinali
English: The maximum daily dose is 720 micrograms (24 tablets per day).
Maltese: Id-doża massima hija ta' 720 mikrogramma (24-il pillola kuljum).
English: Ventricular extrasystoles
Maltese: Fibrillazzjoni atrijali Extrasystoles ventrikulari
English: - The other ingredient(s) are mannitol (E421), dicalcium phosphate, hypromellose, croscarmellose sodium, Indigo Carmine (E132), stearic acid, and magnesium stearate.
Maltese: - Is-sustanza/i l-oħra hija/huma mannitol (E421), dicalcium phosphate, hypromellose, croscarmellose sodium, Indigo Carmine (E132), stearic acid, u magnesium stearate.
English: - Regularly prescribed opioid medicine (e.g. morphine, codeine, fentanyl, hydromorphone, oxycodone).
Maltese: - Mediċina opjojde preskritta b'mod regolari (eż. morphine, codeine, fentanyl, hydromorphone,
English: Dzuveo will be available in cartons of 5 and 10.
Maltese: Dzuveo se jkun disponibbli f'kartuniet ta' 5 u 10.
English: The Ames test revealed no mutagenic activity of sufentanil.
Maltese: Mutaġeniċità It-test Ames ma żvela ebda attività mutaġenika ta' sufentanil.
English: Of the 221 patients, 147 received active treatment and 74 received placebo.
Maltese: Mill-221 pazjent, 147 ingħataw kura attiva u 74 ingħataw plaċebo.
English: ≥1/10,000 to
Maltese: ≥ 1/10,000 sa < 1/1,000
English: 35, 80339 Munich, Germany.
Maltese: FGK Representative Service GmbH, Heimeranstr. 35, 80339 Munich, Il-Ġermanja.
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) ta' 19%, żieda flesponiment globali għas-sustanza attiva (AUC) ta' 77% u jdewwem iż-żmien sakemm tintlaħaq il konċentrazzjoni massima b'41%.
English: Electrocardiogram abnormal
Maltese: Elettrokardjogramma anormali
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: Calcium hydrogen phosphate Hypromellose Croscarmellose sodium Indigo carmine -E132 Stearic acid
Maltese: Hypromellose Croscarmellose sodium Indigo carmine -E132 Stearic acid Magnesium stearate 6.2 Inkompatibbiltajiet
English: Significant respiratory depression or pulmonary compromise.
Maltese: Depressjoni respiratorja sinifikanti jew kompromess pulmonari.
English: - Vision disturbances, eye pain.
Maltese: - Disturbi fil-vista, uġigħ fl-għajnejn.
English: It measures 3 mm in diameter and is enclosed within a single-dose applicator (labelled [sublingual tablet]).
Maltese: Għandha dijametru ta' 3 mm u tiġi magħluqa f'applikatur ta' doża waħda (tikkettat [sublingual tablet]).
English: Direct effects of sufentanil on myocardial function were not observed.
Maltese: Ma ġewx osservati effetti diretti ta' sufentanil fuq il-funzjoni mijokardijaka.
English: Interaction with cytochrome P450-3A4 enzyme
Maltese: Interazzjoni mal-enzima ta' ċitokromu P450-3A4
English: Analgesia
Maltese: Analġeżija
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 gastrointestinali ta' sufentanil jinkludu tnaqqis fil-motilità propulsiva, tnaqqis fis sekrezzjoni u żieda fit-ton tal-muskoli (sa spażmi) tal-isfinteri tal-passaġġ gastrointestinali (ara sezzjoni 4.4).
English: Primary pharmacodynamics effects
Maltese: Effetti farmakodinamiċi primarji
English: Respiratory Depression
Maltese: Depressjoni Respiratorja
English: Studies in rats have revealed reduced fertility and enhanced embryo mortality (see section 5.3).
Maltese: Studji fil-firien urew tnaqqis fil-fertilità u żieda fil-mortalità tal-embrijun (ara sezzjoni 5.3).
English: Tachycardia Sinus tachycardia
Maltese: Takikardija Takikardija tassinus
English: Patients using Dzuveo had a mean SPID12 score that was superior to patients using placebo (25.8 vs. 13.1) in abdominal surgery patients (p<0.001) and (5.93 vs. -6.7) in bunionectomy patients (p=0.005) respectively.
Maltese: Il-pazjenti li użaw Dzuveo kellhom punteġġ SPID12 medjus ogħla mill-pazjenti li użaw il-plaċebo (25.8 vs. 13.1) fil-pazjenti li kellhom intervent kirurġiku addominali (p<0.001) u (5.93 vs.
English: Secondary pharmacodynamics effects
Maltese: Effetti farmakodinamiċi sekondarji
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Propak Health Ltd
Maltese: Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott Propak Health Ltd
English: Maximum concentrations of sufentanil are achieved approximately 60 minutes after a single dose; this is shortened to approximately 40 minutes following repeated hourly dosing.
Maltese: Il-konċentrazzjonijiet massimi ta' sufentanil jintlaħqu madwar 60 minuta wara doża waħda; dan ilperjodu jitnaqqas għal madwar 40 minuta wara dożi ripetuti kull siegħa.
English: • Risk Management Plan (RMP)
Maltese: • Pjan ta' Ġestjoni tar-Riskju (RMP)
English: If swallowed, the oral bioavailability of Dzuveo is only 9% which would result in a subtherapeutic dose.
Maltese: Jekk tinbela', il-bijodisponibbiltà ta' Dzuveo hija biss 9% li tirriżulta f'doża sottoterapewtika.
English: This may range from hypoventilation to respiratory arrest.
Maltese: Din tista' tvarja minn ipoventilazzjoni għal arrest respiratorju.
English: Pharmacotherapeutic group: Anesthetics, opioid anesthetics, ATC Code: N01AH03.
Maltese: Anestetiċi, anestetiċi opjojdi, Kodiċi ATC:
English: Blood urea increased Electrocardiogram T wave abnormal
Maltese: Mewġa T tal elettrokardjogramma anormali
English: No pharmacokinetic data exist for sufentanil in paediatric patients.
Maltese: Ma teżisti ebda data farmakokinetika għal sufentanil fil-pazjenti pedjatriċi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first utilisation: 25 June 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 25 Ġunju 2018
English: Hypomagnesaemia Hypoproteinaemia Hyperkalaemia Diabetes mellitus Hyperglycaemia Hyperlipidaemia Hypophosphataemia Hypovolaemia
Maltese: Ipomagnesemja Ipoproteinimja Iperkalemija Dijabete mellitus Ipergliċemija
English: Dzuveo with alcohol
Maltese: Dzuveo mal-alkoħol
English: Eye pain Visual disturbance
Maltese: Disturb fil-vista
English: - Medicines for the treatment of depression known as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
Maltese: Serotonin Selettivi (SSRIs, Selective Serotonin Reuptake Inhibitors), Inibituri ta' Teħid mill-Ġdid ta' Serotonin Norepinephrine (SNRIs, Serotonin Norepinephrine Reuptake Inhibitors) jew Inibituri tal
English: Sufentanil is rapidly metabolised to a number of inactive metabolites, with oxidative N- and O-dealkylation being the major routes of elimination.
Maltese: Sufentanil huwa metabolizzat malajr għal numru ta' metaboliti inattivi, bil-N- u O-dealkylation ossidattivi li huma r-rotot ewlenin ta' eliminazzjoni.
English: Angina pectoris Atrial fibrillation
Maltese: Bradikardija Anġina pectoris
English: Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare
Maltese: ≥ 1/1,000 sa < 1/100
English: After single administration of Dzuveo, mean terminal phase half-live of 13.4 hours (range of 2.5 to 34.4 hours) was observed.
Maltese: Wara l-għoti ta' darba ta' Dzuveo, ġiet osservata half-life tal-fażi terminali medja ta' 13.4 sigħat (medda ta' 2.5 sa 34.4 sigħat).
English: Risk from concomitant use of sedative medicines such as benzodiazepines or related medicinal products
Maltese: Riskju minn użu fl-istess ħin ta' mediċini sedattivi bħal benzodiazepines jew prodotti mediċinali relatati
English: In a study of a sufentanil 15 microgram sublingual tablet (with the same formulation as the 30 microgram tablet), a substantially lower bioavailability of 9% after oral intake (swallowed) was observed.
Maltese: Fi studju ta' pillola sufentanil ta' 15-il mikrogramma għal taħt l-ilsien (bl-istess formulazzjoni tal pillola ta' 30 mikrogramma), ġiet osservata bijodisponibbiltà aktar baxxa ta' 9% wara t-teħid millħalq (tinbela').
English: Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme.
Maltese: Sufentanil hija metabolizzata prinċipalment mill-enzima ċitokromu P450-3A4 tal-bniedem.
English: Discard the Lock.
Maltese: Armi l-Lokk.
English: The frequencies are defined as:
Maltese: Il-frekwenzi huma ddefiniti bħala:
English: In the abdominal surgery trial, mean baseline pain intensity was 5.61 (0.13) for sufentanil-treated patients and 5.48 (0.18) for placebo-treated patients.
Maltese: Fil-prova tal-kirurġija addominali, l- intensità medja tal-uġigħ tal-linja bażi kienet 5.61 (0.13) għall-pazjenti kkurati b'sufentanil u 5.48 (0.18) għall-pazjenti kkurati bi plaċebo.
English: Sufentanil is mainly metabolised in humans by the cytochrome P450-3A4 enzyme system (see section 4.5).
Maltese: Sufentanil huwa metabolizzat fil-bnedmin prinċipalment bis-sistema tal-enzimi taċ-ċitokromu P450-3A4 (ara sezzjoni 4.5).
English: Bronchitis Conjunctivitis infective Pharyngitis
Maltese: Bronkite Kunġuntivite infettiva Farinġite
English: Sufentanil may cause respiratory depression (see section 4.4) and also suppresses the cough reflex.
Maltese: Sufentanil tista' tikkawża depressjoni respiratorja (ara sezzjoni 4.4) kif ukoll trażżan ir-riflessi tassogħla.
English: The most serious adverse reaction of sufentanil is respiratory depression, which occurred at a rate of 0.6% in sufentanil clinical trials.
Maltese: Ir-reazzjoni avversa l-aktar serja ta' sufentanil hija d-depressjoni respiratorja, li seħħet f'rata ta' 0.6% fil-provi kliniċi b'sufentanil.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkati fis-sezzjoni 6.1.
English: Mean (SEM) baseline intensity in these trials was 6.48 (0.21) for the 12-hour bunionectomy trial in the sufenatil-treated patients and 5.98 (0.30) for placebo-treated patients.
Maltese: L-intensità tal-linja bażi medja (SEM) f'dawn il-provi kienet 6.48 (0.21) għall-prova ta' 12-il siegħa tal-bunionectomy fil pazjenti kkurati b'sufenatil u 5.98 (0.30) għall-pazjenti kkurati bi plaċebo.
English: Hypoaesthesia oral
Maltese: Ipostesija orali
English: Musculoskeletal pain Musculoskeletal chest pain
Maltese: Uġigħ muskoloskeletali fis-sider
English: For Dzuveo, population pharmacokinetic analysis showed an effect of age, with an 18% decrease in clearance in the elderly (above 65 years of age).
Maltese: Għal Dzuveo, l analiżi farmakokinetika tal-popolazzjoni wriet effett tal-età bi tnaqqis fl-eliminazzjoni ta' 18% fl anzjani (li għandhom aktar minn 65 sena).
English: The concomitant use of CNS depressants including barbiturates, benzodiazepines, neuroleptics or other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance respiratory depression.
Maltese: L-użu fl-istess ħin ta' depressanti CNS inklużi barbiturati, benzodjazepini, newrolettiċi jew opjojdi oħrajn, gassijiet aloġeni jew depressanti CNS oħrajn mhux selettivi (eż. l-alkoħol) jistgħu jżidu d depressjoni respiratorja.
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Maltese: malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u fin nutrizzjoni
English: With Dzuveo, first dose clearance in the typical patient of weight 78.5 kg and age 47 years is 84.2 L/hr.
Maltese: B'Dzuveo, it-tneħħija tal-ewwel doża fil-pazjent tipiku li jiżen 78.5 kg u għandu 47 sena hija 84.
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: Monoamine Oxidase (MAOIs, Monoamine Oxidase Inhibitors), jista' jżid ir-riskju tas-sindrome ta' serotonin, kundizzjoni li potenzjalment hija ta' theddida għall-ħajjja.
English: Dzuveo should not be used beyond 48 hours.
Maltese: Dzuveo ma għandux jintuża għal aktar minn 48 siegħa.
English: The most commonly reported adverse reactions seen in clinical trials and from post marketing experience with sufentanil containing products were nausea, vomiting and pyrexia (≥1/10 patients) (see section 4.4).
Maltese: wara t-tqegħid fis-suq ta' prodotti li fihom sufentanil kienu dardir, rimettar u deni (≥1/10 pazjenti)
English: Sufentanil may cause respiratory depression, for which the degree/severity is dose related.
Maltese: Sufentanil tista' tikkawża depressjoni respiratorja, li l-livell/severità tagħha huma relatati mad-doża.
English: With administration of Dzuveo, clinical duration of analgesia is largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50% of Cmax after discontinuation of dosing (context sensitive half-time or CST½) rather than by the terminal half-life.
Maltese: Bl-għoti ta' Dzuveo, it-tul ta' żmien kliniku ta' analġeżija huwa ddeterminat l-aktar mill-ħin meħtieġ biex il-konċentrazzjoni ta' sufentanil fil-plażma taqa' minn Cmax għal 50% ta' Cmax wara li jitwaqqaf id-dożar (half-time sensittiv għall-kuntest jew CST½) aktar milli permezz tal-half-life terminali.
English: Pruritus
Maltese: BORŻA
English: Patients were predominantly female (63%), mean age was 41 years (range 18-74 years), BMI 15.8 to 53.5 kg/m2, race was predominately White (69%) and Black or African American (21%).
Maltese: 8 sa 53.5 kg/m2, ir-razza predominanti kienet Bajda (69%) u Sewda jew Afro-Amerikana (21%).
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: Bradypnoea Epistaxis Hiccups Apnoea Atelectasis Hypoventilation Pulmonary embolism Pulmonary oedema Respiratory distress Respiratory failure Wheezing
Maltese: Bradipneja Epistassi Sulluzzu Apnea Atelektasi
English: - Keep this leaflet.
Maltese: Stat ta' konfużjoni
English: Pharyngolaryngeal pain
Maltese: Popolazzjoni pedjatrika
English: Rescue analgesia was allowed in both studies, with a higher proportion of patients in the placebo group requiring rescue medication due to inadequate analgesia (64.8%, 100%; abdominal, bunionectomy) than in the sufentanil group (27.1%, 70.0%;.
Maltese: 100%; addominali, bunionectomy) milli fil-grupp ta' sufentanil (27.1%, 70.0%; addominali, bunionectomy).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazole, ritonavir) cannot be excluded.
Maltese: Effetti simili b'inibituri ta' CYP3A4 b'saħħithom oħra (eż.
English: Anaemia Leukocytosis
Maltese: Anemija wara loperazzjoni
English: Dzuveo is packaged in a polypropylene single-dose applicator, which is packaged in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.
Maltese: Dzuveo huwa ppakkjat f'applikatur ta' doża waħda tal-polipropilene, li huwa ppakkjat f'film talpoliester/LDPE/fojl tal-aluminjum/qartas tal-LDPE b'assorbitur tal-ossiġnu.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for sufentanil, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal sufentanil, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: However, elderly patients should be observed closely for adverse reactions of sufentanil (see section 5.2).
Maltese: Madankollu, il-pazjenti anzjani għandhom jiġu osservati mill-qrib għal reazzjonijiet avversi ta' sufentanil (ara sezzjoni 5.2).
English: - Swelling, uncomfortable sensations in your chest, chills, and weakness (lack of energy).
Maltese: - Nefħa, sensazzjonijiet ta' skumdità fis-sider, sirda, u dgħufija (nuqqas ta' enerġija).
English: High doses of intravenously administered sufentanil are known to cause muscle rigidity, probably as a result of an effect on the substantia nigra and the striate nucleus.
Maltese: probabbilment bħala riżultat ta' effett fuq is-subsantia nigra u n-nukleu striate.
English: Contents of the pack and other information What Dzuveo contains - The active substance is sufentanil.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Dzuveo - Is-sustanza attiva hi sufentanil.
English: Dzuveo is indicated for the management of acute moderate to severe pain in adult patients.
Maltese: Dzuveo huwa indikat għall-ġestjoni ta' uġigħ akut minn moderat sa sever f'pazjenti adulti.
English: Each pack contains either 5 or 10 pouches.
Maltese: Kull pakkett fih jew 5 jew 10 boroż.
English: There are no clinical data on the effects of sufentanil on fertility.
Maltese: Ma hemm l-ebda data klinika dwar l-effetti ta' sufentanil fuq il-fertilità.
English: Others
Maltese: JIS
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 14il litru u l-volum tad-distribuzzjoni fi stat fiss huwa ta' madwar 350 litru.
English: Appendix V
Maltese: ANNESS IV
English: In the two placebo-controlled clinical trials, the mean number of doses used in the first 6 hours of dosing was 2.8 tablets, with less frequent dosing in the following 6 hours (mean of 1.7 tablets).
Maltese: Fil-provi kliniċi kkontrollati bi plaċebo, in-numru medju ta' dożi użati fl-ewwel 6 sigħat tad-dożar kienu 2.8 pilloli, b'dożar inqas frekwenti fis-6 sigħat ta' wara (medja ta' 1.7 pilloli).
English: Hyperbilirubinaemia
Maltese: Żieda fil-bilirubin fiddemm
English: The pouch contains one clear plastic SDA with a single blue-coloured tablet housed in the tip, and an oxygen absorber packet.
Maltese: Ilborża fiha SDA wieħed tal-plastik trasparenti b'pillola waħda ta' lewn blu fil-ponta tiegħu, u pakkett li jassorbi l-ossiġnu.
English: Increased resorption of foetuses and reduced litter size was noted in the high dose females suggesting the potential for foetotoxicity, likely due to maternal toxicity.
Maltese: Aktar riassorbiment tal-feti u tnaqqis fid-daqs tal-boton kien innutat fin- nisa li ngħataw doża ogħla li jindika l-potenzjal għall-fetotossiċità, aktarx dovuta għat-tossiċità materna.
English: Minimum 1 hour dosing interval.
Maltese: Intervall minimu ta' siegħa bejn doża u oħra.
English: Dzuveo is to be administered by a healthcare professional in a medically monitored setting only.
Maltese: Dzuveo għandu jingħata biss minn professjonist tal-kura tas-saħħa f'ambjent mediku kkontrollat.
English: Dzuveo is to be administered by a healthcare professional from a disposable single-dose applicator (see section 6.6).
Maltese: Dzuveo għandu jingħata minn professjonist tal-kura tas-saħħa minn applikatur ta' doża waħda li jintuża darba biss (ara sezzjoni 6.6).
English: • The minimum dosing interval of one sublingual tablet per hour, in order to prevent / minimise the important identified risk of respiratory depression and the important potential risk of overdose;
Maltese: • L-intervall ta' dożar minimu ta' pillola waħda għal taħt l-ilsien fis-siegħa, biex jiġi evitat/jitnaqqas ir-riskju kbir identifikat ta' depressjoni respiratorja u r-riskju potenzjali kbir ta'
English: After multiple administrations, a longer mean terminal half-life of 15.7 hours (range 2.4 to 42.7 hours) was observed, owing to the higher plasma concentrations of sufentanil achieved after repeated dosing and due to the possibility to quantify these concentrations over a longer time period.
Maltese: Wara l-għoti għal diversi drabi, ġiet osservata half-life terminali medja itwal ta' 15.7 sigħat (medda ta' 2.4 sa 42.7 sigħat), minħabba l-kisba ta' konċentrazzjonijiet filplażma ogħla ta' sufentanil wara dożi ripetuti u minħabba l-possibbiltà ta' kwantifikazzjoni ta' dawn il- konċentrazzjonijiet fuq perjodu ta' żmien itwal.
English: Onset of analgesia, as measured by pain intensity difference to baseline scores, was greater (p<0.05) for sufentanil versus placebo by 15 minutes after the first dose in the abdominal study and 30 minutes in the bunionectomy study.
Maltese: Il-bidu tal-analġeżija, kif imkejjel mid-differenza fl-intensità tal-uġigħ mill-punteġġi tal-linja bażi, kien akbar (p<0.05) għal sufentanil kontra l-plaċebo bi 15-il minuta wara l-ewwel doża fl-istudju addominali u 30 minuta fl-istudju tal-bunionectomy.
English: Tabulated list of adverse reactions
Maltese: Tabella b'lista tar-reazzjonijiet avversi
English: The MAH shall ensure that in each MS where Dzuveo is marketed, all HCPs (i.e. physicians, hospital pharmacists, and nurses) who are expected to prescribe / administer the product are provided with a Healthcare Professional Guide, outlining critical information for the safe and effective use of Dzuveo, including:
Maltese: Il-MAH għandu jiżgura li f'kull Stat Membru fejn jinbiegħ Dzuveo, l-professjonisti kollha tas-saħħa (jiġifieri tobba, spiżjara tal-isptar u infermiera) li huma mistennija li jippreskrivu/jagħtu l-prodott jingħataw Gwida għall-Professjonisti tal-Kura tas-Saħħa, li tispjega l-informazzjoni essenzjali għallużu sigur u effettiv ta' Dzuveo, inklużi:
English: In particular,
Maltese: NN:
English: Drug withdrawal syndrome
Maltese: Sindrome ta' astinenza middroga
English: Dzuveo 30 micrograms sublingual tablets sufentanil
Maltese: Pilloli Dzuveo ta' 30 mikrogramma għal taħt l-ilsien sufentanil
English: See section 6.6 for instructions regarding handling of the Dzuveo sublingual tablet and applicator.
Maltese: Ara sezzjoni 6.6 għal struzzjonijiet dwar l-immaniġġjar ta' Dzuveo pillola għal taħt l-ilsien u tal applikatur.