FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatigue, malaise peripheral oedema, withdrawal syndrome*, neonatal withdrawal syndrome
Maltese: Għeja kbira, telqa edema periferali, sindrome ta' rtirar tal-mediċina*,
English: Instanyl 200 micrograms/dose nasal spray, solution 1.8 ml containing 3.60 mg fentanyl ensuring the delivery of 10 doses of 200 micrograms 2.9 ml containing 5.80 mg fentanyl ensuring the delivery of 20 doses of 200 micrograms 5.0 ml containing 10.00 mg fentanyl ensuring the delivery of 40 doses of 200 micrograms
Maltese: Instanyl 200 mikrogramma/sprej iddożat għall-imnieħer, soluzzjoni 1.8 ml li fiha 3.60 mg fentanyl li tiżgura l-forniment ta' 10 dożi ta' 200 mikrogramma 2.9 ml li fiha 5.80 mg fentanyl li tiżgura l-forniment ta' 20 doża ta' 200 mikrogramma 5.0 ml li fiha 10.
English: The nasal spray comes in four different pack sizes: 2.0 ml (equal to 10 doses), 3.2 ml (equal to 20 doses), 4.3 ml (equal to 30 doses) and 5.3 ml (equal to 40 doses).
Maltese: 2.0 ml (ugwali għal 10 dożi), 3.2 ml (ugwali għal 20 doża), 4.3 ml (ugwali għal 30 doża) u 5.3 ml (ugwali għal 40 doża).
English: Nasal spray, solution 2.0 ml.
Maltese: Sprej għall-imnieħer, soluzzjoni 2.9 ml
English: The nasal spray is ready, when the display shows the number of doses (i.e. 10, 20, 30 or 40 doses).
Maltese: L-isprej nażali jkun lest meta d-display turi n-numru ta' dożi (i.e. 10, 20, 30 jew 40 doża).
English: Other medicines and Instanyl
Maltese: Mediċini oħra u Instanyl
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Maltese: Pazjenti li jirċievu terapija ta' manteniment b'opijojdi huma dwak li qed jieħdu tal-anqas 60 mg ta' morfina orali kuljum, tal-anqas 25 mikrogramma ta' fentanyl ġol-ġilda kull siegħa, tal-anqas 30 mg oxycodone kuljum, tal-anqas 8 mg ta' hydromorphone orali kuljum jew doża ekwianalġeżika ta'
English: Comparable bioavailability (AUC) of fentanyl was achieved with and without oxymetazoline, while fentanyl Cmax decreased and Tmax increased by a factor two when oxymetazoline was administered.
Maltese: Kien hemm bijodisponibilità komparabbli (AUC) għal fentanyl bi u mingħajr oxymetazoline,
English: INFORMATION IN BRAILLE Instanyl 200, single-dose
Maltese: Instanyl 200, doża waħda
English: The nasal spray container contains batteries.
Maltese: Il-kontenitur tal-isprej nażali fih il-batteriji.
English: - if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Maltese: - jekk m'intix qed tuża b'mod regolari mediċina opoid (eż codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) preskritta kuljum fuq skeda regolari, għal ta' l-inqas ġimgħa, għall-kontroll tal-uġigħ persistenti tiegħek.
English: The nasal spray is supplied in a child-resistant outer box and comes in three different pack sizes: 1.8 ml (equal to 10 doses), 2.9 ml (equal to 20 doses) and 5.0 ml (equal to 40 doses).
Maltese: It-tagħmir tal-isprej jiġi f'kaxxa ta' barra li hi reżistenti għal ftuħ mit-tfal u jiġi fi tliet daqsijiet differenti ta' pakkett: 1.8 ml (ugwali għal 10 dożi), 2.9 ml (ugwali għal 20 doża) u 5.0 ml (ugwali għal 40 doża).
English: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Maltese: 1 ml fih fentanyl citrate ekwivalenti għal 500 mikrogramma fentanyl.
English: Fall, diarrhoea, convulsions (fits), loss of consciousness, swelling of arms or legs, seeing or hearing things that are not really there (hallucinations), drug dependence (addiction), drug abuse, fatigue, malaise, withdrawal syndrome (may manifest by the occurrence of the following side effects nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shortness of breath.
Maltese: Waqa', dijarea, konvulżjonijiet, telf ta' konoxxenza, nefħa fid-dirgħajn jew fir-riġlejn, tara jew tisma affarijiet li mhux vera hemm (alluċinazzjonijiet), dipendenza fuq id-drogi (vizzju), abbuż mid-droga, għeja kbira, telqa, sindrome ta' rtirar tal-mediċina (tista' tiġi osservata bl-okkorrenza tal-effetti sekondarji li ġejjin, dardir, rimettar, dijarea, ansjetà, tertir, rogħda, u għaraq), qtugħ ta' nifs.
English: Ear and Labyrinth disorders Vertigo
Maltese: Disturbi fil-widnejn u fissistema labirintika
English: Explanation
Maltese: LISTA
English: Instanyl may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38 °C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
Maltese: Instanyl jista' jinteraġixxi ma' dawn il-mediċini u jista' jkollok bidliet fl-istat mentali (eż. aġitazzjoni, alluċinazzjonijiet, koma), u effetti oħra bħal temperatura tal-ġisem ogħla minn 38 °C, żieda fir-rata tat-taħbita tal-qalb, pressjoni tad-demm instabbli, u esaġerazzjoni tar-riflessi, riġidità fil-muskoli, nuqqas ta' koordinazzjoni u/jew sintomi gastrointestinali (eż. dardir, rimettar, dijarea).
English: Hyperalgesia
Maltese: Iperalġeżija
English: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Maltese: 1 ml fih fentanyl citrate ekwivalenti għal 1,000 mikrogramma fentanyl.
English: The number of doses in the display changes to ‘5'.
Maltese: In-numru ta' dożi fid-display jinbidel għal "5".
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Maltese: Depressjoni respiratorja li ssegwi doża eċċessiva tista'
English: The results of summary of PID at 60 minutes (SPID0-60) showed that all strengths of Instanyl had significantly higher mean SPID0-60 scores compared with placebo (p < 0.001) demonstrating better pain relief of Instanyl compared to placebo during 60 minutes.
Maltese: Ir-riżultati ta' sommarju ta' PID wara 60 minuta (SPID0-60) urew li kull qawwa ta' Instanyl kellha punteġġi medji sinifikament ogħla ta' SPID0-60 meta mqabbla ma' plaċebo (p< 0.001) li juri li l-uġigħ jittaffa' aħjar b'Instanyl meta mqabbel ma' plaċebo għal 60 minuta.
English: 200 micrograms/dose labelling is greenish-blue.
Maltese: It-tikkettar tal-200 mikrogramma/doża hu blu fl-aħdar.
English: • aprepitant (used to treat severe nausea);
Maltese: • aprepitant (użat biex jittratta tqalligħ sever) ;
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic medicinal products such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with medicinal products which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Maltese: L-iżvilupp ta' sindrome tas-serotonin li jista' jkun ta' periklu għall-ħajja jista' jseħħ bl-użu konkomitanti ta' prodotti mediċinali serotonerġiċi bħall-Inibituri Selettivi tat-Teħid mill-Ġdid tas-Serotonin (SSRIs) u l-Inibituri tat-Teħid mill-Ġdid tas-Serotonin Norepinephrine (SNRIs), u ma' prodotti mediċinali li jdgħajfu l-metaboliżmu tas-serotonin (inklużi l-Inibituri tal-Monoamine Oxidase
English: COUNTDOWN-CLOCK symbol
Maltese: Simbolu tal-ARLOĠĠ TAL-COUNTDOWN
English: Posology
Maltese: Spjegazzjoni
English: 200 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms fentanyl.
Maltese: 200 microgramma: dose 1 (100 mikrolitru) fiha fentanyl citrate ekwivalenti għal 200 mikrogramma fentanyl.
English: In a pharmacokinetic interaction study it was found that the maximum plasma concentration of nasally applied fentanyl was reduced about 50% by the concomitant use of oxymetazoline, while the time to reach Cmax (Tmax) was doubled.
Maltese: Fi studju ta' interazzjoni farmakokinetika, instab li l-konċentrazzjoni massima ta' fentanyl li jittieħed mill-imnieħer ġol plażma tnaqqset b'50% bl-użu fl-istess ħin ta' oxymetazoline, filwaqt li l-ħin sabiex jintlaħaq Cmax (Tmax) kien irdoppjat.
English: Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Maltese: Sinjali ta' tossiċità huma sedazzjoni profonda, atassja, mijosi, konvulsjonijiet u depressjoni respiratorja, bħala s-sintomu ewlieni.
English: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Maltese: 1 ml fih fentanyl citrate ekwivalenti għal 2,000 mikrogramma fentanyl.
English: 200 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Maltese: 200 microgramma/doża: 1 ml fih fentanyl citrate ekwivalenti għal 2,000 mikrogramma fentanyl.
English: The adverse reactions considered to be at least possibly related to treatment in the clinical trials of Instanyl are included in the table below.
Maltese: Ir-reazzjonijiet avversi kkunsidrati li huma tal-anqas possibilment marbuta ma' trattament fil-provi kliniċi ta' Instanyl huma inklużi fit-tabella hawn isfel.
English: Instanyl 200 micrograms/dose nasal spray, solution.
Maltese: Instanyl 200 mikrogramma/sprej iddożat għall-imnieħer, soluzzjoni.
English: EU/1/09/531/010 EU/1/09/531/011 EU/1/09/531/012 EU/1/09/531/013
Maltese: EU/1/09/531/011 EU/1/09/531/012 EU/1/09/531/013
English: 2.0 ml containing 2.00 mg fentanyl ensuring the delivery of 10 doses of 100 micrograms 3.2 ml containing 3.20 mg fentanyl ensuring the delivery of 20 doses of 100 micrograms 4.3 ml containing 4.30 mg fentanyl ensuring the delivery of 30 doses of 100 micrograms 5.3 ml containing 5.30 mg fentanyl ensuring the delivery of 40 doses of 100 micrograms
Maltese: 3.2 ml li fiha 3.20 mg fentanyl li tiżgura l-forniment ta' 20 doża ta' 100 mikrogramma 4.3 ml li fiha 4.30 mg fentanyl li tiżgura l-forniment ta' 30 doża ta' 100 mikrogramma 5.3 ml li fiha 5.30 mg fentanyl li tiżgura l-forniment ta' 40 doża ta' 100 microgramma
English: Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution fentanyl
Maltese: Informazzjoni għall-utent Instanyl 50 mikrogramma/sprej iddożat tal-imnieħer, soluzzjoni Instanyl 100 mikrogramma/sprej iddożat tal-imnieħer, soluzzjoni Instanyl 200 mikrogramma/sprej iddożat tal-imnieħer, soluzzjoni fentanyl
English: The influence of hepatic and renal impairment on the pharmacokinetics of Instanyl have not been evaluated; however, when administered intravenously the clearance of fentanyl has shown to be altered due to hepatic and renal impairment caused by alterations in metabolic clearance and plasma proteins.
Maltese: L-influwenza ta' indeboliment tal-fwied u tal-kliewi fuq il-farmakokinetiċi ta' Instanyl ma ġewx evalwati; madankollu, meta jingħata ġol-vina it-tneħħija ta' fentanyl intweriet li nbidlet minħabba l-indeboliment tal-fwied jew tal-kliewi minħabba alterazzjonijiet fit-tneħħija metabolika u l-proteini fil-plażma.
English: 100 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Maltese: 100 mikrogramma/doża: 1 ml fih fentanyl citrate ekwivalenti għal 1,000 mikrogramma fentanyl.
English: After intravenous administration of fentanyl the initial distribution half-life is approximately 6 minutes and a similar half-life is seen after the nasal administration of Instanyl.
Maltese: Wara l-għoti minn ġol-vina ta' fentanyl il-half-life tal-firxa inizjali hi madwar 6 minuti u half-life simili tidher wara l-għoti mill-imnieħer ta' Instanyl.
English: INFORMATION IN BRAILLE Instanyl 100, single-dose
Maltese: Instanyl 100, doża waħda
English: NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray Fentanyl
Maltese: Instanyl 50 mikrogramma/sprej tal-imnieħer iddożat Fentanyl
English: muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
Maltese: abnormalitajiet newromuskolari (eż. iperrifleksija, nuqqas ta' koordinazzjoni, riġidità), u/jew sintomi gastrointestinali (eż. dardir, rimettar, dijarea).
English: The nasal spray container has an electronic display, a dose counter, a lock-out mechanism and a child-resistant cap.
Maltese: Il-kontenitur tal-isprej nażali għandu display elettroniku, kontro doża, mekkaniżmu lock out u għatu reżistenti għat-tfal.
English: 50 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Maltese: 50 mikrogramma/doża: 1 ml fih fentanyl citrate ekwivalenti għal 500 mikrogramma fentanyl.
English: EU/1/09/531/018 EU/1/09/531/019 EU/1/09/531/020 EU/1/09/531/021
Maltese: EU/1/09/531/018 EU/1/09/531/019 EU/1/09/531/020
English: EU/1/09/531/022 EU/1/09/531/023 EU/1/09/531/024 EU/1/09/531/025
Maltese: EU/1/09/531/022 EU/1/09/531/023 EU/1/09/531/024
English: Tel./Tél.
Maltese: Takeda Belgium Tel./Tél.:
English: EU/1/09/531/030 EU/1/09/531/031 EU/1/09/531/032 EU/1/09/531/033
Maltese: EU/1/09/531/031 EU/1/09/531/032 EU/1/09/531/033
English: Do not drink alcohol whilst being treated with Instanyl, as it can increase the risk of experiencing dangerous side effects.
Maltese: M'għandekx tixrob alkoħol waqt li qed tiġi trattat b'Instanyl, peress li jista' jżid ir-riskju li jkollok effetti perikolużi oħrajn.
English: 18 months
Maltese: 18 xahar.
English: Instanyl should be administered with caution to patients with moderate to severe renal impairment (see section 4.4).
Maltese: Instanyl għandu jingħata b'kawtela lil pazjenti li għandhom indeboliment fil-fwied li hu bejn moderat għal sever (ara sezzjoni 4.4).
English: This observation was most distinct for patients receiving Instanyl 50 micrograms.
Maltese: Din l-osservazzjoni dehret l-aktar f'pazjenti li rċivew Instanyl ta' 50 mikrogramma.
English: 2.0 ml containing 1.00 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 3.2 ml containing 1.60 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 4.3 ml containing 2.15 mg fentanyl ensuring the delivery of 30 doses of 50 micrograms 5.3 ml containing 2.65 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms
Maltese: 2.0 ml li fiha 1.00 mg fentanyl li tiżgura l-forniment ta' 10 dożi ta' 50 mikrogramma 3.2 ml li fiha 1.60 mg fentanyl li tiżgura l-forniment ta' 20 doża ta' 50 mikrogramma 4.3 ml li fiha 2.15 mg fentanyl li tiżgura l-forniment ta' 30 doża ta' 50 mikrogramma 5.3 ml li fiha 2.65 mg fentanyl li tiżgura l-forniment ta' 40 doża ta' 50 mikrogramma
English: Instanyl 200 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Maltese: Instanyl 200 mikrogramma/sprej iddożat għall-imnieħer, soluzzjoni Kull ml ta' soluzzjoni fih fentanyl citrate ekwivalenti għal 2,000 mikrogramma fentanyl.
English: 100 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms fentanyl.
Maltese: 100 mikrogramma: doża 1 (100 mikrolitru) fiha fentanyl citrate ekwivalenti għal 100 mikrogramma fentanyl.
English: Preparing Instanyl nasal spray for use:
Maltese: Effetti oħra rapportati wara l-użu ta' Instanyl:
English: Instanyl 100 micrograms/dose nasal spray, solution.
Maltese: Instanyl 100 mikrogramma/sprej iddożat għall-imnieħer, soluzzjoni.
English: The concomitant use of other central nervous system depressants (including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquillisers, sedating antihistamines and alcohol) and skeletal muscle relaxants, may produce additive depressant effects: hypoventilation, hypotension, profound sedation, coma or death may occur.
Maltese: L-użu fl-istess ħin ta' sedattivi oħra li jaġixxu fuq is-sistema nervuża ċentrali (li jinkludu opijojdi, sedattivi, ipnotiċi, anestetiċi ġenerali, phenothiazines, kalmanti, antiħistamini sedattivi u alkoħol) u rilassaturi tal-muskoli skelettriċi, jistgħu jikkaġunaw effetti depressanti addittivi: jistgħu jseħħu iperventilazzjoni, pressjoni baxxa, sedazzjoni qawwija, koma jew mewt.
English: - Use one dose of Instanyl - Wait 10 minutes
Maltese: - Stenna 10 minuti
English: Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Maltese: Instanyl hu indikat għall-ġestjoni ta' uġigħ qawwi li jiġi f'daqqa f'adulti li jkunu diġà qed jirċievu terapija ta' manteniment bl-opijojdi għal uġigħ kroniku mill-kanċer.
English: How to store Instanyl
Maltese: X'fih Instanyl
English: - if you take medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain) as you may experience symptoms of withdrawal syndrome.
Maltese: - jekk tieħu mediċini msejħa agonist/antagonisti parzjali eż. buprenorphine, nalbuphine u pentazoncine (mediċini għat-trattament tal-uġigħ) għax jista' jkollok sintomi ta' sindrome ta' rtirar.
English: Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes.
Maltese: Ma kienux osservati effetti fuq l-iżvilupp somatiku u mġieba tal-wild.
English: The clinical experience with Instanyl in patients with background opioid treatment equivalent to ≥ 500 mg/day morphine or ≥ 200 micrograms/hour transdermal fentanyl is limited.
Maltese: Hemm biss esperjenza ristretta b'Instanyl f'pazjenti bi trattament ta' opijojdi fl-isfond ekwivalenti għal ≥ 500 mg/jum morfina jew ≥ 200 mikrogramma/siegħa b'fentanyl li jingħata minn ġol-ġilda.
English: Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.
Maltese: Trattament għal sa erba' episodji ta' uġigħ qawwi li jiġi f'daqqa, kull wieħed minnhom b'mhux aktar minn żewġ dożi separati minn xulxin b' tal-anqas 10 minuti.
English: Instanyl 50 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Maltese: U KWANTITATTIVA Instanyl 50 mikrogrammi/sprej iddożat għall-imnieħer, soluzzjoni Kull ml ta' soluzzjoni fih fentanyl citrate ekwivalenti għal 500 mikrogramma fentanyl.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms nasal spray Fentanyl
Maltese: Instanyl 200 mikrogramma/sprej tal-imnieħer iddożat Fentanyl
English: 50 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms fentanyl.
Maltese: 50 mikrogramma: doża 1 (100 mikrolitru) fiha fentanyl citrate ekwivalenti għal 50 mikrogramma fentanyl.
English: Sleeplessness, drowsiness, convulsive muscle contractions, abnormal sensation of the skin even unpleasant, change of taste, motion sickness, low blood pressure, severe breathing problems, nose bleeds, nasal ulcer, runny nose, constipation, inflammation of the mouth, dry mouth, skin pain, itching of the skin, fever.
Maltese: Ma tistax torqod, ngħas, kontrazzjonijiet konvulżivi tal-muskoli, sensazzjoni abnormali fuq il-ġilda anke spjaċevoli, bidla fit-togħma, deni taċ-ċaqlieq, pressjoni baxxa tad-demm, problemi severi biex tieħu n-nifs, l-imnieħer jinfaraġ, ulċera fl-imnieħer, flisjoni, stitikezza, infjammazzjoni tal-ħalq, ħalq xott, uġigħ tal-ġilda, ħakk tal-ġilda, deni.
English: Takeda Pharma A/S Τηλ: +45 46 77 11 11
Maltese: Τηλ: +45 46 77 11 11
English: The content is:
Maltese: Tel.:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
Maltese: Takeda Pharma A/S
English: The nasal spray must be pumped 5 times (primed), before it can be used (see section ‘Preparing the Instanyl nasal spray').
Maltese: L-isprej nażali jrid jiġi ppumpjat 5 darbiet (ipprajmjat), qabel ma jkun jista' jintuża (ara s-sezzjoni ‘Kif tipprepara l-isprej nażali Instanyl').
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX - CARTON (Single Dose)
Maltese: TIKKETTA / FLIXKUN (Ħafna dożi)
English: 1 dose (100 microlitres) contains 50 micrograms fentanyl.
Maltese: Doża waħda (100 mikrolitru) fiha 50 mikrogramma fentanyl.
English: Instanyl 100 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Maltese: Instanyl 100 mikrogramma/sprej iddożat għall-imnieħer, soluzzjoni Kull ml ta' soluzzjoni fih fentanyl citrate ekwivalenti għal 1,000 mikrogramma fentanyl.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray Fentanyl
Maltese: Instanyl 100 mikrogramma/sprej iddożat għall-imnieħer, soluzzjoni Fentanyl
English: 1 dose (100 microlitres) contains 200 micrograms fentanyl.
Maltese: Doża waħda (100 mikrolitru) fiha 200 mikrogramma fentanyl.
English: Clinically significant respiratory depression may occur with fentanyl, and patients must be observed for these effects.
Maltese: Depressjoni respiratorja klinikament sinifikanti tista' sseħħ b'fentanyl, u l-pazjenti għandhom jiġu osservati għal dawn l-effetti.
English: Adequate body temperature and fluid intake should be maintained.
Maltese: Temperatura adegwata tal-ġisem u t-teħid ta' fluwidu għandu jiġi mantnut.
English: Coadministration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Maltese: L-għoti fl-istess ħin ta' fentanyl ma' sustanza serotoninerġika, bħal Inibitur Selettiv tat-Teħid mill-Ġdid tas-Serotonin (SSRI) jew Inibitur tat-Teħid mill-Ġdid tas-Serotonin Norepinephrine (SNRI) jew Inibitur tal-Monoamine Oxidase (MAOI), jista' jżid ir-riskju tas-sindrome tas-serotonin, li hija kundizzjoni li tista' tkun ta' periklu għall-ħajja.
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Maltese: L-użu fl-istess ħin ta' kalmanti li jaġixxu fuq is-sistema nervuża ċentrali jistgħu jgħollu r-riskju ta' depressjoni respiratorja (ara sezzjoni 4.5).
English: In the clinical studies in cancer patients, the most frequent strengths used were 100 and 200 micrograms; however, patients should be titrated to the optimal dose of Instanyl for treating BTP in cancer (see section 4.2).
Maltese: Fl-istudji kliniċi f'pazjenti b'kanċer, il-qawwiet użati l-aktar frekwenti kienu dawk tal-100 u 200 mikrogramma; madanakollu, il-pazjenti għandhom jiġu ttitrati għad-doża ottimali ta' Instanyl għat-trattament ta' BTP f'kanċer (ara sezzjoni 4.2).
English: • Instanyl nasal spray is only indicated and licensed for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Maltese: • L-isprej għall-imnieħer Instanyl huwa indikat biss għall-ġestjoni ta' uġigħ qawwi f'daqqa f'adulti li diġà qed jirċievi terapija ta' manteniment b'opijodi għal uġigħ kroniku tal-kanċer.
English: INSTRUCTIONS FOR USE OF INSTANYL
Maltese: Instanyl meta twaqqaf Instanyl.
English: 1 dose (100 microlitres) contains 100 micrograms fentanyl.
Maltese: Doża waħda (100 mikrolitru) fiha 100 mikrogramma fentanyl.
English: 1 puff (100 microlitres) contains 200 micrograms fentanyl.
Maltese: Nefħa waħda (100 mikrolitru) fiha 200 mikrogramma fentanyl.
English: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms (mcg) fentanyl
Maltese: Doża waħda (100 mikrolitru) fiha fentanyl citrate ekwivalenti għal 200 mikrogramma (µg) fentanyl
English: - The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Maltese: - Ir-riskju ta' effetti sekondarji jiżdied jekk qiegħed tieħu mediċini bħal ċerti antidipressanti jew antipsikotiċi.
English: Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injections
Maltese: Fih ukoll: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, ilma ppurifikat
English: In animal studies, male and female fertility was impaired at sedative doses (see section 5.3).
Maltese: il-fertilità tar-raġel u tal-mara kienet indebolita f'dożi sedattivi (ara sezzjoni 5.3).