FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Teysuno in all subsets of the paediatric population in gastric adenocarcinoma (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea dwar il-Mediċini ddiferiet l-obbligu li jiġu ppreżentati r-riżultati riżultati talistudju b'Teysuno fis-sottosetts kollha tal-popolazzjoni pedjatrika b'adenokarċinoma gastrika (ara sezzjoni 4.2 għal informazzjoni fuq l-użu pedjatriku).
English: No consistent relationship was seen between absolute QTcF interval values or change from Baseline values and maximum plasma concentration of Teysuno components.
Maltese: L-ebda relazzjoni konsistenti ma dehret bejn il-valuri assoluti tal-intervall ta' QTcF u l-bidla mill-valuri tal-linja bażi ta' riferiment u l-konċentrazzjoni massima fil-plażma ta' komponenti ta' Teysuno.
English: Following a reduced dose of Teysuno 20 mg/m2 administered once daily to the severe renal impairment group (CrCl < 30 ml/min), the single-dose AUC0-inf and multiple-dose AUC0-τ values for 5-FU were approximately 2-fold higher in the severe renal impairment group compared to those observed in the normal renal function group receiving 30 mg/m2 twice daily.
Maltese: Wara doża mnaqqsa ta' 20 mg/m2 Teysuno mogħtija darba kuljum lill-pazjenti fil-grupp b'indeboliment tal-kliewi sever (CrCl < 30 ml/min), il-valuri tal-AUC0-inf ta'-doża waħda tal-'AUC0-τ ta' doża multipla għal 5-FU kienu madwar darbtejn ogħla fil-grupp b'indeboliment tal-kliewi sever meta mqabbel ma' dak osservat fil-grupp tal-funzjoni normali tal-kliewi li kienu qed jirċievu 30 mg/m2 darbtejn kuljum.
English: - Gut and mouth: fluid in the abdomen, gastroesophageal reflux disease, increased salivary secretion, excessive burping and belching, lip inflammation, gastrointestinal disorder, oral pain, abnormal contractions of muscles of the oesophagus, blockage in the stomach and intestine, stomach ulcer, retroperitoneal fibrosis, teeth that crack or break easily, swallowing difficulty, disorder of the salivary gland, haemorrhoids
Maltese: - Mentali: tara u tisma' affarijiet li mhumiex hemm, bidla fil-personalità, mhux kapaċi toqgħod bilqegħda, konfużjoni, tħossok nervuż, dipressjoni, impotenza sesswali - Sistema nervuża:, disturb fil-vuċi, inkapaċità biex titkellem u tifhem il-kliem, problemi ta' memorja, pass mhux stabbli, problemi ta' bilanċ, dgħufija fuq naħa waħda tal-ġisem, ħedla, infjammazzjoni tan-nervi, sens distort ta' xamm, disfunzjoni tal-moħħ, sturdament, nuqqas ta' konoxxenza, puplesija, aċċessjonijiet, - Għajnejn: ħakk u ħmura tal-għajnejn, reazzjonijiet allerġiċi fl-għajnejn, il-kappel tal-għajn ta' fuq titbaxxa - Widnejn: vertigo, il-widna timblokka, skonfort tal-widnejn
English: Teysuno will be given with another anti-cancer medicine called cisplatin.
Maltese: Teysuno jista' jitkompla wara l-waqfien ta' cisplatin.
English: - Skin: loss of skin colour, peeling skin, excessive body hair, nail shrinkage, excessive sweating, - General: general condition worsening, weight increase, redness and swelling at the injection site, cancer pain and bleeding, multiple organ failure - Changes in blood tests: high blood sugar, high blood lipids, changes in blood clotting time, high blood cell counts, low or high protein level - Other: frequent urination, blood in urine, neck pain, back pain, breast pain, muscle tightness or cramps, joint swelling, limb discomfort, muscle weakness, arthritis inflammation and pain
Maltese: - Mentali: tara u tisma' affarijiet li mhumiex hemm, bidla fil-personalità, mhux kapaċi toqgħod bilqegħda, konfużjoni, tħossok nervuż, dipressjoni, impotenza sesswali - Sistema nervuża:, disturb fil-vuċi, inkapaċità biex titkellem u tifhem il-kliem, problemi ta' memorja, pass mhux stabbli, problemi ta' bilanċ, dgħufija fuq naħa waħda tal-ġisem, ħedla, infjammazzjoni tan-nervi, sens distort ta' xamm, disfunzjoni tal-moħħ, sturdament, nuqqas ta' konoxxenza, puplesija, aċċessjoniiet, - Għajnejn: ħakk u ħmura tal-għajnejn, reazzjonijiet allerġiċi fl-għajnejn, il-kappel tal-għajn ta' fuq titbaxxa - Widnejn: vertigo, il-widna timblokka, skonfort tal-widnejn - Il-qalb: taħbit tal-qalb irregolari u mgħaġġel, uġigħ fis-sider, akkumulazzjoni ta' fluwidu żejjed madwar il-qalb, attakk tal-qalb, falliment tal-qalb - Vażi tad-demm: infjammazzjoni ta' vina, fwawar sħan - Passaġġi tal-pulmun u tal-imnieħer:, mnieħer iqattar, disturb fil-vuċi, mnieħer imblokkat, eritema farinġeali, deni tal-ħuxlief
English: Hypotension, deep vein thrombosis, hypertension
Maltese: Pressjoni baxxa, trombożi profonda tal-vini, pressjoni għolja,
English: Patients with moderate renal impairment (CrCl 30 to 50 ml/min) who received a reduced dose of 20 mg/m2 twice daily showed no significant increase in mean 5-FU AUC0-inf relative to that of the normal group.
Maltese: Pazjenti b'indeboliment tal-kliewi moderat (CrCl 30 sa 50 ml/min) li ħadu doża mnaqqsa ta' 20 mg/m2
English: Caution is advised as co-administration of Teysuno and coumarin anticoagulation therapy may increase the risk of bleeding (see section 4.4).
Maltese: Il-kawtela hija rakkomandata peress li l-għoti fl-istess ħin ta' Teysuno u terapija antikoagulanti b'kumarin tista' żżid ir-riskju ta' emorraġiji (ara sezzjoni 4.4).
English: Teysuno doses
Maltese: ANNESS II
English: Febrile neutropenia, lymphopenia
Maltese: Newtropenija biddeni, Limfopenija,
English: You must not breastfeed if you are taking Teysuno.
Maltese: Aħsel sninek u omħot bilmod.
English: Repeat-dose toxicity studies in rats, dogs and monkeys produced changes typically associated with administration of an anti-cancer medicinal product eliciting cytotoxic effects on populations of rapidly dividing cells, such as anaemia, decrease in the immune and digestive system function, disruption of spermatogenesis, and atrophy in male and female reproductive organs.
Maltese: Dożi ripetuti dwar it-tossiċità fil-firien, il-klieb u x-xadini kkaġunaw bidliet li huma tipikament assoċjati mal-għoti ta' prodott mediċinali ta' kontra l-kanċer li jwassal għal effetti ċitotossiċi fuq popolazzjonijiet ta' ċelluli li jikondividu malajr, bħal anemija, tnaqqis fil-funzjoni immuni u tassistema diġestiva, tħarbit ta' spermatoġenisi, u atropija fl-organi ta' riproduzzjoni tar-raġel u tal-mara.
English: The overall safety profile of Teysuno in combination with cisplatin is based primarily on clinical study data from 593 patients with advanced gastric cancer treated with this regimen.
Maltese: Il-profil tas-sigurtà globali ta' Teysuno flimkien ma' cisplatin hu bażat prinċipalment fuq tagħif minn studju kliniku li sar fuq 593 pazjent b'kanċer tal-istonku avvanzat li ġew kkurati b'dan il-programm ta' kura.
English: Efforts should be made to ensure early detection of ocular reactions, including an early ophthalmologic consultation in the event of any persistent or vision-reducing ocular symptoms such as lacrimation or corneal symptoms.
Maltese: Il-maġġoranza tar-reazzjonijiet avversi huma riversibbli u jistgħu jiġu ġestiti b'terapija sintomatika, waqfien tad-doża u tnaqqis fiddoża.
English: A study of the effect of Teysuno on cardiac repolarisation conducted in advanced cancer patients met the definition for a negative study according to International Conference on Harmonisation (ICH) guidelines.
Maltese: Studju dwar l-effett ta' Teysuno fuq ripolarizzazzjoni kardijaka li saret f'pazjenti b'kanċer avvanzat issodisfat it-tifsira għal studju negattiv skont il-linji gwida tal-Konferenza Internazzjonali dwar l-Armonizzazzjoni (ICH).
English: Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition
Maltese: Nuqqas ta' rqad Stat konfużjonali, irrikwitezza, disturb ta' personalità, alluċinazzjoni, dipressjoni, ansjetà, tnaqqis fl-aptit sesswali, inibizzjoni sesswali
English: The activity of a coumarin-derivative anticoagulant was enhanced by Teysuno.
Maltese: L-attività ta' antikoagulant derivat minn kumarin kien mħarrax b'Teysuno.
English: The corresponding median Tmax are 12-15 minutes.
Maltese: It-Tmax medjan korrispondenti huwa ta' bejn 12-15 minuta.
English: Instanyl shows linear kinetics.
Maltese: Instanyl juri kinetiċi linejari.
English: Serotonin syndrome
Maltese: Sindrome tas-serotonin
English: BATTERY symbol
Maltese: Simbolu tal-BATTERIJA
English: Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Germany
Maltese: Takeda GmbH Robert-Bosch-Strasse 8 D - 78224
English: Symbols in the electronic display
Maltese: Simboli fid-display elettronika
English: Recurrent episodes of epistaxis (see section 4.4).
Maltese: Episodji rikorrenti ta' epistassi (ara sezzjoni 4.4).
English: 1.8 ml - 10 doses 2.9 ml - 20 doses 5.0 ml - 40 doses
Maltese: 1.8 ml - 10 dożi 2.9 ml - 20 doża 5.0 ml - 40 doża
English: The absolute bioavailability of Instanyl is approximately 89.
Maltese: Il-bijodisponibilità assoluta ta' Instanyl hi madwar 89%.
English: Sedation, myoclonus, paraesthesia, dysaesthesia, dysgeusia
Maltese: Sedazzjoni, mijklonus, paraestesja, disaestesja, disgewsja
English: Store below 30 C.
Maltese: Aħżen f'temperatura taħt 30 °C.
English: United Kingdom Takeda UK Ltd Tel.: +44 (0)1628 537 900
Maltese: Takeda UK Ltd Tel.: +44 (0)1628 537 900
English: Fentanyl exhibits three compartment distribution kinetics.
Maltese: Fentanyl jesebixxi tliet kinetiċi ta' distribuzzjoni kompartamentali.
English: The patients had an average of 1 to 4 episodes per day while taking maintenance opioid therapy.
Maltese: Il-pazjenti kellhom medja ta' bejn 1 sa 4 episodji kuljum waqt li kienu qed jieħdu terapija ta' manteniment ta' opijojdi.
English: 10 doses (2.0 ml) 20 doses (3.2 ml) 30 doses (4.3 ml) 40 doses (5.3 ml)
Maltese: 10 dożi (2.0 ml) 20 doża (3.2 ml) 20 doża (4.3 ml) 40 doża (5.3 ml)
English: • CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections);
Maltese: • impedituri CYP3A4 bħal ketoconazole, itraconazole, jew fluconazole (użati fit-trattament għal infezzjonijiet tal-moffa) ;
English: A priming sequence of 5 actuations of the nasal spray container is required, indicated by ‘P5', ‘P4', ‘P3', ‘P2' and ‘P1' in the display.
Maltese: Sekwenza ta' pprajmjar ta' 5 attivazzjonijiet tal-isprej nażali hi meħtieġa, u din hi indikata bħala "P5", "P4", "P3", "P2" u "P1" fid-display.
English: • ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection);
Maltese: • ritonavir, nelfinavir, amprenavir, u fosamprenavir (mediċini li jgħinu jikkontrollaw l-infezzjoni ta' HIV) ;
English: Ελλάδα
Maltese: Nuqqas ta' rqad
English: All three strengths of Instanyl demonstrated statistically significant (p < 0.001) higher pain intensity difference at 10 minutes (PID10) compared with placebo.
Maltese: It-tliet qawwiet ta' Instanyl urew differenzi statistikament sinifikanti (p< 0.001) fl-intensità ta' uġigħ ogħla wara 10 minuti (PID10) meta mqabbla mal-plaċebo.
English: The major metabolite, norfentanyl is inactive.
Maltese: Il-metabolit ewlieni, norfentanyl mhux attiv.
English: • troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial infections);
Maltese: • troleandomycin, clarithromycin, jew erythromycin (mediċini użati għal trattament ta'
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħrufa (frekwenza ma tistax tiġi stmata mid-data disponibbli):
English: The efficacy and safety of Instanyl (50, 100 and 200 micrograms) have been assessed in two randomised, double-blind, cross-over, placebo-controlled pivotal studies in 279 opioid-tolerant adult cancer patients (age 32-86 years) with breakthrough pain (BTP).
Maltese: L-effikaċja u s-sigurtà ta' Instanyl (50, 100 u 200 mikrogramma) ġew assessjati f'żewġ studji każwali, double-blind, inkroċjati u pivotali kontrollati bi plaċebo f'279 pazjent adult bil-kanċer li huma tolleranti għal opijojdi (fl-etajiet 32-86 sena) b'uġigħ qawwi li jiġi f'daqqa (BTP).
English: The display counts downward after each pump (P5, P4, P3, P2 and P1).
Maltese: In-numru fid-display jonqos b'wieħed wara kull ippumpjar (P5, P4, P3, P2 u P1).
English: Abuse potential and dependence
Maltese: Potenzjal t'abbuż u dipendenza
English: The secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Maltese: L-effetti farmakoloġiċi sekondarji huma depressjoni sekondarja, bradikardja, stitikezza, mijosi, dipendenza fiżika u ewforija.
English: Pharmacotherapeutic group: Analgesics, opioids, ATC code: N02AB03
Maltese: Analġeżiċi, opijojdi, Kodiċi ATC:
English: Instanyl comes in different pack sizes of 2, 6, 8 and 10 single-dose containers.
Maltese: Instanyl jiġi f'daqsijiet ta' kontenituri ta' doża waħda differenti ta' 2, 6, 8 u 10.
English: The following categories are used to rank the undesirable effects by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); and very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari (≥ 1/10,000 sa
English: Date of latest renewal: 01 July 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju 2009 Data tal-aħħar tiġdid: 01 ta' Lulju 2019
English: Somnolence, dizziness, headache
Maltese: Stitikezza, stomatite,
English: Furthermore, Instanyl was significantly superior to placebo in BTP relief at 10, 20, 40, and 60 minutes following administration.
Maltese: Barra minn hekk Instanyl kien sinifikament superjuri sabiex jittaffa l-uġigħ qawwi li jiġi f'daqqa wara 10, 20, 40 u 60 minuta wara li ngħata.
English: Symptoms of overdose are:
Maltese: Sintomi ta' doża eċċessiva jinkludu:
English: Fentanyl is metabolised primarily in the liver via CYP3A4.
Maltese: Fentanyl jiġi metabolizzat prinċipalment fil-fwied b'CYP3A4.
English: Instanyl with food, drink and alcohol
Maltese: Instanyl ma' ikel, xorb u alkoħol
English: Instanyl in doses above 400 micrograms have not been evaluated in clinical trials.
Maltese: Instanyl f'dożi ogħla minn 400 mikrogramma ma ġewx valutati fi provi kliniċi.
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of Instanyl.
Maltese: L-għoti flimkien ma' prodotti mediċinali li jinduċu l-attività ta' 3A4 jista' jnaqqas l-effikaċja ta' Instanyl.
English: The display will now turn on and show ‘P5'.
Maltese: Id-display issa se tixgħel u turi "P5".
English: This is indicated by a ‘P' in the display.
Maltese: Dan ikun indikat bħala "P"
English: The display now shows ‘P3' and the lock symbol.
Maltese: Id-display issa turi "P3" u s-simbolu tal-katnazz.
English: Fentanyl use may be associated with bradycardia.
Maltese: L-użu ta' fentanyl jista' jkun assoċjat ma' bradikardija.
English: You may experience withdrawal symptoms similar to the possible side effects of Instanyl when discontinuing Instanyl.
Maltese: Tista' tesperjenza sintomu ta' nuqqas ta' teħid tal-prodott simili għall-effetti sekondarji possibbli ta' Instanyl meta twaqqaf Instanyl.
English: Repeat this procedure for ‘P2' and ‘P1' (press the white button and pump) until the display changes to show the number of doses in the nasal spray (i.e. 10, 20, 30 or 40 doses) and flashing lock symbol.
Maltese: Irrepeti din il-proċedura għal "P2" u "P1" (agħfas il-buttuna l-bajda u ppompja) sakemm id-display tinbidel u tibda turi n-numru ta' dożi fl-isprej nażali (i.e. 10, 20, 30 jew 40 doża) u simbolu tal-katnazz iteptep.
English: Takeda GmbH Tel.: +49 (0) 800 825 3325 medinfo@takeda.de
Maltese: +49 (0) 800 825 3325 medinfo@takeda.de
English: The primary therapeutic action is analgesia.
Maltese: L-azzjoni terapewtika primarja hi analġesja.
English: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Maltese: It-tolleranza u dipendenza fiżika u/jew psikoloġika jistgħu jiżviluppaw bl-għoti ripetut ta' opijojdi bħal fentanyl.
English: INFORMATION IN BRAILLE Instanyl 200
Maltese: Instanyl 200
English: INFORMATION IN BRAILLE Instanyl 50
Maltese: Instanyl 50
English: 2 single-dose containers 6 single-dose containers 8 single-dose containers 10 single-dose containers
Maltese: 2 kontenituri b'doża waħda 6 kontenituri b'doża waħda 8 kontenituri b'doża waħda 10 kontenituri b'doża waħda
English: Pack sizes: 2, 6, 8 and 10 single-dose containers.
Maltese: Daqsijiet tal-pakkett: kontenituri b'doża waħda ta' 2, 6. 8 u 10.
English: Depending on the nasal spray, the starting number can be 10, 20, 30 or 40.
Maltese: Skont l-isprej nażali, in-numru tal-bidu jista' jkun 10, 20, 30 jew 40.
English: Patients being treated with medicinal products containing sodium oxybate.
Maltese: Pazjenti li qed jiġi kkurati bi prodotti mediċinali li fihom sodium oxybate.
English: Furthermore, studies in female rats revealed reduced fertility and enhanced embryonal mortality.
Maltese: Barra minn hekk studji f'firien nisa wrew fertilità mnaqqsa u żiedafil-mortalità embrijonali.
English: Withdrawal symptoms may be precipitated through the administration of substances with opioid antagonist activity, e.g. naloxone, or mixed agonist/antagonist analgesic (e.g. pentazocine, butorphanol, buprenorphine, nalbuphine).
Maltese: Sintomi ta' tiżmin jistgħu jiġu preċipitati bl-għoti ta' sustanzi b'attività antagonista għal opijojdi, eż. naloxone, jew taħlita analġeżika b'agonista/antagonista (eż. pentazocine, butorphanol, buprenorphine,
English: • diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases).
Maltese: • diltiazem u verapamil (mediċini użati għal pressjoni tad-demm għolja jew mard tal-qalb).
English: - experience extreme dizziness.
Maltese: - ikollok uġigħ konvulsiv.
English: Throat irritation Respiratory depression, epistaxis, nasal ulcer, rhinorrhea
Maltese: epistassi, ulċera nażali, rinorrea
English: The concomitant use of Instanyl with strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, and nelfinavir) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Maltese: Instanyl ma' impedituri qawwija CYP3A4 (eż. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, u nelfinavir) jew impedituri moderati (eż., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, u verapamil) jistgħu jirriżultaw f'żieda fil-konċentrazzjonijiet ta' fentanyl fil-plażma, li jista' jwassal għal reazzjonijiet avversi għal mediċina li jinkludi wkoll depressjoni respiratorja li tista' twassal għal mewt.
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Instanyl is given concurrently with medicinal products that affect CYP3A4 activity.
Maltese: P450 3A4 (CYP3A4), għalhekk interazzjonijiet potenzjali jistgħu jseħħu meta Instanyl jingħata flimkien ma' prodotti mediċinali li jaffettwaw l-attività ta' CYP3A4.
English: INFORMATION IN BRAILLE Instanyl 100
Maltese: Instanyl 100
English: If Instanyl has been administered, an antidote for the child should be readily available.
Maltese: Jekk ingħata Instanyl, antidot għat-tarbija għandu jkun faċilment disponibbli.
English: • To open cut with scissors along the line (above the scissors symbol) on the blister.
Maltese: • Biex tiftaħ aqta' b'imqass tul il-linja pperforata tal-folja (fuq is-simbolu tal-imqass).
English: About 75 of fentanyl is excreted into the urine, mostly as inactive metabolites, with less than 10 as unchanged active substance.
Maltese: Madwar 75% ta' fentanyl jiġi eliminat fl-urina, prinċipalment permezz ta' metaboliti mhux attivi,
English: DoseGuard 2.0 ml containing 4.00 mg fentanyl ensuring the delivery of 10 doses of 200 micrograms
Maltese: DoseGuard 2.0 ml li fiha 4.00 mg fentanyl li tiżgura l-forniment ta' 10 dożi ta' 200 mikrogramma
English: The display now shows ‘P4' and a lock symbol appears.
Maltese: Id-display issa turi "P4" u jidher simbolu ta' katnazz.
English: Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3).
Maltese: L-użu fl-istess ħin ta' prodotti mediċinali li fihom sodium oxybate u fentanyl huwa kontraindikat (ara sezzjoni 4.3).
English: Nasal spray, solution 2.0 ml Nasal spray, solution 3.2 ml Nasal spray, solution 4.3 ml Nasal spray, solution 5.3 ml
Maltese: Sprej għall-imnieħer, soluzzjoni 2.0 ml Sprej għall-imnieħer, soluzzjoni 3.2 ml Sprej għall-imnieħer, soluzzjoni 4.3 ml Sprej għall-imnieħer, soluzzjoni 5.3 ml
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: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal web Ewropew tal-mediċini.
English: - If you are taking a medicine which contains sodium oxybate.
Maltese: - jekk qed tieħu mediċina li fiha sodium oxybate.
English: The plasma protein binding of fentanyl is approximately 80.
Maltese: Il-proteini fil-plażma ta' fentanyl hu madwar 80%.
English: Each titration step (dose strength) should be evaluated in several episodes.
Maltese: Kull stadju ta' tittrazzjoni (qawwa dożata) għandu jiġi valutat f'diversi episodji.
English: A polypropylene (PP) nasal spray container consisting of a glass bottle (brown Type 1 glass) with metering pump.
Maltese: Kontenitur tal-polypropylene (PP) sprej nażali jikkonsisti fi flixkun tal-ħġieġ (kannella tal-ħġieġ Tip 1) bil-pompa metraġġ.
English: Chronic pulmonary disease
Maltese: Mard tal-pulmun kroniku
English: Limited data on pharmacokinetics are available for the use of fentanyl in cachectic (debilitated) patients.
Maltese: Data limitata dwar il-farmakinetika hija disponibbli dwar l-użu ta' fentanyl f'pazjenti kakektiċi (debilitati).
English: PHARMACEUTICAL FORM Nasal spray, solution (nasal spray).
Maltese: GĦAMLA FARMAĊEWTIKA Sprej għall-imnieħer, soluzzjoni (sprej għall-imnieħer).
English: *opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating have been observed with transmucosal fentanyl
Maltese: *sintomi ta' rtirar ta' opioids bħal dardir, rimettar, dijarea, ansjetà, tertir, rogħda, u għaraq kienu osservati b'fentanyl transmukużali
English: DoseGuard Clear, colourless solution.
Maltese: DoseGuard Soluzzjoni ċara, mingħajr kulur.
English: However, higher values for Tmax were observed in a dose-proportionality study in healthy volunteers.
Maltese: Madankollu, ġew osservati valuri ogħla għal Tmax fi studju tal-proporzjonalità tad-doża f'voluntiera b'saħħithom.
English: The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).
Maltese: manteniment ta' kuljum ta' opijojdi fl-istudji kliniċi (ara sezzjoni 5.1).
English: Dose titration
Maltese: Sintomi ta' tiżmin
English: You could experience symptoms of withdrawal syndrome (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating).
Maltese: Jista' jkollok sintomi ta' sindrome ta' rtirar tal-mediċina (dardir, rimettar, dijarea, ansjetà, tertir, rogħda, u għaraq).
English: DK-2630 Taastrup Denmark
Maltese: Taastrup Id-Danimarka
English: INFORMATION IN BRAILLE Instanyl 50, single-dose
Maltese: Instanyl 50, doża waħda
English: For concomitant use of nasal vasoconstrictor see section 4.5.
Maltese: Għal użu fl-istess ħin ta' vażokonstrittur tal-imnieħer ara sezzjoni 4.5.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Water for injections
Maltese: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Ilma ppurifikat