FrancophonIA/ELRC3.0 huggingface dataset:
English: Fentanyl is highly lipophilic and can be absorbed very rapidly through the oral mucosa and more slowly by the conventional gastrointestinal route.
Maltese: Fentanyl huwa lipofiliku ħafna u jista' jiġi assorbit malajr ħafna minn ġol-mukuża orali u aktar bilmod mir-rotta gastro-intestinali konvenzjonali .
English: Risks of concomitant administration with benzodiazepines or related drugs Concomitant use of opioids, including Effentora, with benzodiazepines or related drugs may result in profound sedation, respiratory depression, coma, and death.
Maltese: Riskji ta' għoti flimkien ma' benzodiazepines jew mediċini relatati L-użu konkomitanti ta' opjojdi, inkluż Effentora, flimkien ma' benzodiazepines jew mediċini relatati jista' jwassal għal sedazzjoni profonda, depressjoni respiratorja, koma, u mewt.
English: Drug dependence (addiction)*, Drug abuse, Delirium
Maltese: Dipendenza fuq id-drogi (vizzju)*
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where EFFENTORA is marketed all healthcare professionals who are expected to prescribe EFFENTORA are provided with an information pack containing the following items:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li, wara diskussjonijiet u ftehim mal-Awtoritajiet Kompetenti Nazzjonali f'kull Stat Membru fejn EFFENTORA jkun imqiegħed fis-suq, il-professjonisti kollha fil-qasam mediku li huma mistennija li jagħtu riċetta għal EFFENTORA, ikun pprovduti b'pakkett ta' informazzjoni li jkun fih dawn lelementi li ġejjin:
English: Alternatively, the tablet could be placed sublingually (see section 5.2).
Maltese: B'mod alternattiv, il-pillola tista' titpoġġa taħt l-ilsien (ara sezzjoni 5.2).
English: Following the intravenous administration of fentanyl, less than 7% of the administered dose is excreted unchanged in the urine, and only about 1% is excreted unchanged in the faeces.
Maltese: Wara għoti ġol-vini ta' fentanyl, inqas minn 7% tad-doża mogħtija hija mneħħija mhux mibdula flawrina, u madwar 1% biss hija mneħħija mhux mibdula fl-ippurgar.
English: Effentora tablet once exposed to moisture utilises an effervescent reaction to deliver the active substance.
Maltese: Ladarba pillola Effentora tiġi esposta għall-umdità, din tutilizza reazzjoni effervexxenti biex twassal is-sustanza attiva.
English: Particular caution should be used when titrating Effentora in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Effentora may further decrease respiratory drive to the point of respiratory failure.
Maltese: Għandha tintuża attenzjoni partikulari meta jiġi ttitrat Effentora f'pazjenti b'marda pulmonari ostruttiva kronika mhux severa jew b'kundizzjonijiet mediċi oħra li jippredisponu għal depressjoni respisratorja, minħabba li anki dożi terapewtiċi normali ta' Effentora jistgħu jnaqqsu aktar l-ħidma respiratorja sal-punt ta' insuffiċjenza respiratorja.
English: Nervousness Hallucination Visual hallucination Mental status changes Disorientation
Maltese: Nervożità Alluċinazzjoni Alluċinazzjoni viżwali
English: resulting in a median terminal elimination half-life t1/2 of approximately 22 hours following buccal administration of the effervescent formulation and approximately 18 hours following intravenous administration.
Maltese: Din il-fażi ta' eliminazzjoni hija bil-mod, u twassal għall-half-life t1/2 ta' eliminazzjoni terminali medjana ta' madwar 22 siegħa wara għoti mill-ħalq tal formulazzjoni effervexxenti u ta' madwar 18-il siegħa wara għoti ġol-vini.
English: Norfentanyl is not pharmacologically active in animal studies.
Maltese: Norfentanyl mhux farmakoloġikament attiv fi studji fl-annimali.
English: General introduction
Maltese: Introduzzjoni Ġenerali
English: The differences observed were not clinically significant.
Maltese: Id-differenza osservata ma kienitx ta' sinifikanza klinika.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTURA(I) RESPONSABBLI
English: Carcinogenicity studies (26-week dermal alternative bioassay in Tg.AC transgenic mice; two-year subcutaneous carcinogenicity study in rats) with fentanyl did not reveal any findings indicative of oncogenic potential.
Maltese: Studji dwar il-karċinoġeniċità (bijoanaliżi alternattiv tal-ġilda ta' 26 ġimgħa fi ġrieden Tg.AC transġeniċi; studju ta' sentejn dwar il-karċinoġeniċità taħt il-ġilda fil-firien) b'fentanyl ma żvelax sejbiet li jindikaw potenzjal onkoġeniku.
English: • Do not use this medicine after the expiry/use before date which is stated on the blister package label and the carton.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-pakkett tal-folja u fuq il-kartuna.
English: Oral candidiasis Pharyngitis
Maltese: Infafet fil mukuża orali
English: How to use Effentora
Maltese: TUŻAX Effentora:
English: Tear 2.
Maltese: N02AB03.
English: Insomnia
Maltese: Immaniġġjar
English: Cognitive disorder Motor dysfunction
Maltese: Disturb konoxxittiv Disfunzjoni fil-moviment
English: Co-administration 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: 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: Mean Plasma Concentration Versus Time Profiles Following Singles Doses of EFFENTORA and OTFC in Healthy Subjects
Maltese: Konċentrazzjonijiet Medji fil-Plażma Kontra Ħin Profili Wara Dożi Singoli ta' EFFENTORA u OTFC f'Individwi f'Saħħithom
English: • Any medicines that might have an effect on the way in which your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections), troleandomycine, clarithromycine, or erythromycine (medicines for treatment of bacterial infections), aprepitant (used for severe nausea) and diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases).
Maltese: • Ikollok taħlita tas-sintomi li ġejjin: dardir, rimettar, anoressija, għeja, dgħufija, sturdament u pressjoni tad-demm baxxa. Flimkien, dawn is-sintomi jistgħu jkunu sinjal ta' kondizzjoni potenzjalment ta' periklu għall-ħajja msejħa insuffiċjenza adrenali, kondizzjoni li fiha l-glandoli adrenali ma jipproduċux biżżejjed ormoni.
English: redness, swelling or spots
Maltese: sensazzjoni, ħmura, nefħa jew ponot
English: • 200 micrograms fentanyl (as citrate)
Maltese: • 200 mikrogramma fentanyl (bħala citrate)
English: • drug dependence (addiction)
Maltese: • dipendenza fuq id-drogi (vizzju)
English: Transient pH changes accompanying the effervescent reaction may optimise dissolution (at a lower pH) and membrane permeation (at a higher pH).
Maltese: Bidliet temporanji tal-pH li jseħħu marreazzjoni effervexxenti jistgħu jtejbu d-dissoluzzjoni (f'pH aktar baxxa) u l-porożita tal-membrana (f'pH aktar għoli).
English: • 800 micrograms fentanyl (as citrate)
Maltese: • 800 mikrogramma fentanyl (bħala citrate)
English: Effentora 800 micrograms buccal tablets
Maltese: Effentora 800 mikrogramma pilloli għall-ħalq
English: Hypersensitivity reactions have been reported in post-marketing experience, including rash, erythema, lip and face swelling, and urticaria (see section 4.4).
Maltese: Reazzjonijiet ta' sensittività eċċessiva ġew irrappurtati fl-esperjenza ta' wara t-tqegħid fis-suq, li jinkludu raxx, eritema, nefħa tal-wiċċ u tax-xufftejn, u urtikarja (ara sezzjoni 4.4).
English: Effentora 100 micrograms buccal tablets Each buccal tablet contains 100 micrograms fentanyl (as citrate).
Maltese: U KWANTITATTIVA Effentora 100 mikrogramma pilloli għall-ħalq Kull pillola għall-ħalq fiha 100 mikrogramma fentanyl (bħala citrate).
English: Depression Anxiety Confusional state
Maltese: Indolenza Skonfort fissider
English: Patients who identified an effective dose entered the double-blind phase of the study.
Maltese: Pazjenti li identifikaw doża effettiva daħlu fil-fażi double-blind ta' l-istudju.
English: • fatigue
Maltese: Esofaġite
English: Effentora 600 micrograms buccal tablets
Maltese: Effentora 600 mikrogramma pilloli għall-ħalq
English: The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated, however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Maltese: influwenza ta' indeboliment tal-fwied u renali fuq il-farmakokinetika tal-prodott mediċinali ma ġietx ivvalutata, iżda, intwera li meta mogħti ġol-vini it-tneħħija ta' fentanyl tiġi mibdula f'indeboliment talfwied u renali minħabba bidliet fit-tneħħija metabolika u fil-proteini fil-plażma.
English: Thrombocytopenia
Maltese: Anemija Newtropenija
English: • feeling elated, nervous, abnormal, jittery or slow; seeing or hearing things that are not really there (hallucinations), reduced consciousness, change in mental state, dependence (reliance on the medicine, addiction), disorientation, lack of concentration, loss of balance, vertigo, problem with speaking, ringing in the ear, ear discomfort
Maltese: • griżmejn jaħarqutnaqqis fiċ-ċelluli li jgħinu d-demm jgħaqad • tħossok kuntent ħafna, nervuż, mhux normali, mferfex jew għajjien; tara jew tisma affarijiet li mhux vera hemm (alluċinazzjonijiet), inabilità biex torqod, koxxjenza mnaqqsa, bidla fl-istat mentali, dipendenza (dipendenza fuq il-mediċina, vizzju), diżorjentament, nuqqas ta'
English: • 100 micrograms fentanyl (as citrate)
Maltese: • 100 mikrogramma fentanyl (bħala citrate)
English: • lack of testosterone, abnormal sensation in eye, observing flashes of light, brittle nails
Maltese: • nuqqas ta' testosterone, sensazzjoni mhux normali fl-għajnejn, tara leħħa ta' dawl, dwiefer fraġili
English: • disturbed or blurred vision, red eye
Maltese: • vista disturbata jew imċajpra, għajn ħamra
English: Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating have been observed with transmucosal fentanyl.
Maltese: Jista' jkollok sintomi tas-sindrome ta' rtirar (dardir, rimettar, dijarea, ansjetà, tertir ta' bard, rogħda, u għaraq) waqt li tkun qed tuża dawn il-mediċini.
English: Respiratory arrest*
Maltese: Sensittività eċċessiva*
English: 4 buccal tablets 28 buccal tablets
Maltese: 28 pillola għall-ħalq
English: A comparison study between one 400 mcg Effentora tablet administered either buccally (i.e., between the cheek and the gum) or sublingually met the criteria of bioequivalence.
Maltese: Studju ta' paragun bejn pillola waħda ta' Effentora 400 mcg mogħtija fil-ħalq (i.e., bejn il-ħadd u l-ħanek) jew taħt l-ilsien laħaq il-kriterja ta' bijoekwivalenza.
English: Effentora 200 micrograms buccal tablets
Maltese: Effentora 200 mikrogramma pilloli għall-ħalq
English: • 400 micrograms fentanyl (as citrate)
Maltese: • 400 mikrogramma fentanyl (bħala citrate)
English: Constipation Stomatitis Dry mouth Diarrhoea Abdominal pain Gastrooesophageal reflux disease Stomach discomfort Dyspepsia Toothache
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: • 600 micrograms fentanyl (as citrate)
Maltese: • 600 mikrogramma fentanyl (bħala citrate)
English: Effentora 100 micrograms buccal tablets
Maltese: Effentora 100 mikrogramma pilloli għall-ħalq
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Maltese: Fentanyl huwa lipofiliku ħafna u huwa distribwit sew barra mis-sistema vaskulari, b'volum ta' distribuzzjoni apparenti kbir.
English: Effentora buccal tablets are for oromucosal use.
Maltese: Il-parametri farmakokinetiċi maġġuri huma mniżżla fit-tabella li ġejja.
English: Each tablet of Effentora 200 micrograms, Effentora 400 micrograms, Effentora 600 micrograms and Effentora 800 micrograms contains 20 mg of sodium.
Maltese: Effentora 800 mikrogramma fiha 20 mg ta' sodium.
English: In each Member State where EFFENTORA is marketed the Marketing Authorisation Holder (MAH) shall agree an updated educational programme with the National Competent Authority.
Maltese: F'kull Stat Membru fejn EFFENTORA ikun imqiegħed fis-suq, id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH) għandu jaqbel dwar programm edukattiv aġġornat mal-Awtorità Kompetenti Nazzjonali.
English: With long-term use of fentanyl during pregnancy, there is a risk of neonatal opioid withdrawal syndrome which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
Maltese: B'użu fit-tul ta' fentanyl waqt it-tqala, hemm riskju ta' sindrome ta' rtirar tal-opjojdi fi trabi tat-twelid li jista' jkun ta' periklu għall-ħajja jekk ma jkunx identifikat u ttrattat, u jeħtieġ immaniġġjar skont protokolli żviluppati minn esperti fin-neonatoloġija.
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: Depressed level of consciousness Disturbance in attention Balance disorder Dysarthria
Maltese: Disturbi taddemm u tassistema limfatika
English: Effentora 400 micrograms buccal tablets Each buccal tablet contains 400 micrograms fentanyl (as citrate).
Maltese: Kull pillola għall-ħalq fiha 400 mikrogramma fentanyl (bħala citrate).
English: These might be early symptoms of a serious allergic reaction (anaphylaxis, hypersensitivity; see section 4 under “Serious side effects”)
Maltese: Dawn jistgħu jkunu sintomi bikrija ta' reazzjoni allerġika serja (anafilassi, sensittività eċċessiva; ara sezzjoni 4 taħt “Effetti sekondarji serji”)
English: Effentora 400 micrograms buccal tablets
Maltese: Effentora 400 mikrogramma pilloli għall-ħalq
English: • Safe use, storage and disposal of EFFENTORA.
Maltese: • Użu sigur, ħażna u rimi ta' EFFENTORA.
English: Vertigo Tinnitus Ear discomfort
Maltese: Indeboliment epatiku jew renali
English: • If a single 200 micrograms tablet of Effentora (or two 100 micrograms tablets) is not considered to be efficacious the patient can be instructed to use two 200 micrograms tablets (or four 100 micrograms tablets) to treat the next episode of BTP.
Maltese: • Jekk pillola waħda ta' 200 mikrogramma ta' Effentora (jew żewġ pilloli ta' 100 mikrogramma) m'hijiex ikkunsidrata bħala effikaċi, l-pazjent jista' jiġi rakkomandat biex juża żewġ pilloli ta' 200 mikrogramma (jew erba' pilloli ta' 100 mikrogramma) għall-kura ta' l-episodju ta' BTP ta' wara.
English: Effentora 800 micrograms buccal tablets Each buccal tablet contains 800 micrograms fentanyl (as citrate).
Maltese: Kull pillola għall-ħalq fiha 800 mikrogramma ta' fentanyl (bħala citrate)
English: If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during the titration period.
Maltese: Jekk l-uġigħ li jinħass ma jittaffiex wara 30 minuta, uża biss pillola waħda oħra ta' Effentora waqt il-perijodu ta' titrazzjoni.
English: Do not change doses of Effentora or your other pain medicines on your own.
Maltese: ara sezzjoni 2 taħt “Tużax Effentora” u “Mediċini oħra u Effentora”.
English: Fentanyl can get into breast milk and may cause side effects in the breast-fed infant.
Maltese: Effentora, din hija possibli b'fentanyl u b'opioids oħra.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients.
Maltese: Dawn għandhom affinità għolja għar-riċetturi ta' opioid, b'attività ntrinsika relattivament baxxa, u għalhekk parzjalment inaqqsu l-effett analġeżiku ta' fentanyl u jistgħu jikkawżaw sintomi ta' rtirar f'pazjenti dipendenti fuq l-opioids.
English: Blister packs are supplied in cartons of 4 or 28 tablets.
Maltese: Pakketti tal-folja huma fornuti f'kartuna ta' 4 jew 28 pillola.
English: Peripheral oedema Fatigue Asthenia Drug withdrawal syndrome* Chills
Maltese: Deni Sindrome ta' rtirar tal mediċina fi trabi tattwelid (ara sezzjoni
English: CYP3A4 inducers Co-administration with agents that induce 3A4 activity may reduce the efficacy of Effentora.
Maltese: L-għoti flimkien ma' sustanzi li jinduċu l-attività ta' 3A4 tista' tnaqqas l-effikaċja ta' Effentora.
English: If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 400 micrograms tablet of Effentora.
Maltese: Jekk din id-doża hija kkunsidrata li hija d-doża effettiva, kura ta' episodji suċċessivi ta' BTP tista' titkompla b'pillola waħda ta' 400 mikrogramma ta' Effentora.
English: There are no human data on fertility available.
Maltese: Fertilità M'hemm l-ebda dejta mill-bnedmin disponibbli dwar il-fertilità.
English: Effentora 200 micrograms buccal tablets Each buccal tablet contains 200 micrograms fentanyl (as citrate).
Maltese: Kull pillola għall-ħalq fiha 200 mikrogramma ta' fentanyl (bħala citrate)
English: It is important that the maintenance opioid treatment used to treat the patient's persistent pain has been stabilised before Effentora therapy begins and that the patient continues to be treated with the maintenance opioid treatment whilst taking Effentora.
Maltese: Trattament ta' manteniment b'opioid Huwa importanti li t-trattament ta' manteniment b'opioid użat għat-trattament tal-uġigħ persistenti tal pazjent ikun ġie stabilizzat qabel tinbeda terapija b'Effentora u li l-pazjent ikompli jiġi kkurat bi trattament ta' manteniment ta' opioid waqt li qed jieħu Effentora.
English: Effentora employs a delivery technology which utilises an effervescent reaction which enhances the rate and extent of fentanyl absorbed through the buccal mucosa.
Maltese: Effentora juża teknoloġija ta' tqassim li tutilizza reazzjoni effervexxenti li ttejjeb ir-rata u l-kwantità ta' assorbiment ta' fentanyl minn ġol-mukuża tal-ħalq.
English: Oral mucosal blistering Dry lip
Maltese: Jekk tieqaf tuża Effentora
English: Effentora is a pain-relieving medicine known as an opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain.
Maltese: Effentora huwa mediċina li ttaffi l-uġigħ magħrufa bħala opioid, li tintuża għall-kura ta' uġugħ li jinħass f'pazjenti adulti bil-kanċer li diġà qed jieħdu mediċini opioid ta' l-uġigħ għall-uġigħ persistenti (l-ħin kollu) tal-kanċer.
English: • Store in the original package in order to protect from moisture.
Maltese: • Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdita'.
English: Effentora 600 micrograms buccal tablets Each buccal tablet contains 600 micrograms fentanyl (as citrate).
Maltese: Kull pillola għall-ħalq fiha 600 mikrogramma ta' fentanyl (bħala citrate)
English: Peel
Maltese: Ċarrat
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jaffetwaw sa persuna waħda minn kull 100
English: Place in buccal cavity.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: • You drink alcohol; please refer to section Effentora with food, drink and alcohol.
Maltese: • Tixrob l-alkoħol; jekk jogħġbok irreferi għas-sezzjoni ‘Effentora ma' ikel, xorb u alkoħol'.
English: Pyrexia Neonatal withdrawal syndrome (see section 4.6)
Maltese: Id-doża u t-tul tal-użu konkomitanti għandhom ikunu limitati (ara sezzjoni 4.4).
English: Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
Maltese: Xi bidliet li jistgħu jiġu osservati jinkludu żieda fil-prolactin fis-serum, u tnaqqis ta' cortisol u ta' testosterone filplażma.
English: The analgesic effects of fentanyl are related to its plasma level.
Maltese: L-effetti analġeżiċi ta' fentanyl huma relatati mal-livell tiegħu fil-plażma.
English: The concomitant use of alcohol with fentanyl can produce increased depressant effects which may result in a fatal outcome (see section 4.5).
Maltese: L-użu konkomitanti ta' alkoħol ma' fentanyl jista' jipproduċi żieda fl-effetti depressanti li jistgħu jwasslu għal riżultat fatali (ara sezzjoni 4.5).
English: A Q&A document, providing answers to potential questions on the following topics:
Maltese: Dokument b'mistoqsijiet u tweġibiet li jipprovdi tweġibiet għal mistoqsijiet potenzjali fuq ittemi li ġejjin:
English: Effentora should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Maltese: Fil-kuntest ta' doża eċċessiva kienu osservati telf ta' koxjenza u waqfien respiratorju (ara sezzjoni 4.9).
English: Respiratory, thoracic and mediastinal disorders
Maltese: Żieda fil-pressjoni intrakranjali, indeboliment fil-koxjenza
English: If Effentora is administered, an antidote for the child should be readily available.
Maltese: Jekk Effentora jingħata, antidotu għat-tarbija għandu jkun disponibbli malajr.
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “6”.
Maltese: Pillola b'uċuħ ċatti, bajda, tonda bix-xfar imtajra, fuq naħa waħda b'“C” imqabbża u fuq in-naħa loħra b'“6”.
English: • flushing
Maltese: Fwawar
English: Cold sweat Facial swelling Generalised pruritus Alopecia
Maltese: Mard tarrifluss gastroesofag ali
English: The rate of development of tolerance varies widely among individuals.
Maltese: Ir-rata ta' żvilupp ta' tolleranza tvarja ħafna fost individwi.
English: Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio.
Maltese: Titrazzjoni f'pazjenti li ħa jaqilbu minn prodotti oħra li fihom fentanyl Minħabba l-profili ta' assorbiment differenti, il-bidla m'għandiex issir f'proporzjon ta' 1:1.
English: • Peel the blister backing to expose the tablet.
Maltese: • Iftaħ il-folja biss meta tkun lest biex tuża l-pillola.
English: Pregnancy
Maltese: Dispneja
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is considered secondary to the sedative effects of fentanyl in animal studies.
Maltese: Fi studju dwar il-fertilità u l-iżvilupp bikri ta' l-embriju fil-firien, kien osservat effett medjat mill-irġiel b'dożi għolja (300 mcg/kg/kuljum) u huwa kkunsidrat li hu sekondarju għall-effetti sedattivi ta'
English: Sedative medicines such as benzodiazepines or related drugs The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
Maltese: Mediċini sedattivi bħal benzodiazepines jew mediċini relatati L-użu ta' opjojdi flimkien ma' mediċini sedattivi bħal benzodiazepines jew mediċini relatati jżid irriskju ta' sedazzjoni, depressjoni respiratorja, koma u mewt minħabba effett depressanti addittiv fuq is-CNS.
English: Each blister contains 4 buccal tablets, supplied in cartons of 4 or 28 buccal tablets.
Maltese: Kull folja fiha 4 pilloli għall-ħalq, fornuti f'kartun ta' 4 jew 28 pillola għall-ħalq.
English: vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shaking, falls, chills
Maltese: irritazzjoni, parestesija, anestesija, eritema,
English: Flat-faced, white, round bevelled-edge tablet, embossed on one side with a “C” and on the other side with “8”.
Maltese: Pillola b'uċuħ ċatti, bajda, tonda bix-xfar imtajra, fuq naħa waħda b'“C” imqabbża u fuq in-naħa loħra b'“8”.