FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical data in healthy volunteers support CYP2C8 as being the most important enzyme involved in repaglinide metabolism with CYP3A4 playing a minor role, but the relative contribution of CYP3A4 can be increased if CYP2C8 is inhibited.
Maltese: Informazzjoni klinika f'voluntiera b'saħħithom tappoġġja l-fatt li CYP2C8 hi l-iktar enzima importanti involuta fil-metaboliżmu ta' repaglinide, b'CYP3A4 għandha rwol iżgħar, iżda lkontribuzzjoni relattiva ta' CYP3A4 tista' tiżdied jekk CYP2C8 tkun impeduta.
English: * see section Description of selected adverse reactions below
Maltese: * ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi partikulari aktar 'l isfel Deskrizzjoni ta' reazzjonijiet avversi partikulari
English: • Deferasirox (used to reduce chronic iron overload).
Maltese: • Deferasirox ( użat biex jitnaqqas l-ammont kroniku żejjed ta' ħadid)
English: • Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers).
Maltese: • Mediċini anti-infjammatorji mhux sterojdi (NSAID)
English: Repaglinide Teva 0.5 mg tablets EU/1/09/530/001-005
Maltese: EU/1/09/530/001-005
English: Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
Maltese: Meta repaglinide (doża waħda ta' 0.25 mg) ingħata flimkien ma' trimethoprim (160 mg darbtejn kuljum), inibitur moderat ta' CYP2C8, kien hemm żieda fl-AUC, fis-Cmax u fil-t½ ta' repaglinide (1.6 darbiet, 1.4 darbiet u 1.2 darbiet rispettivament), mingħajr ebda effett statistikament sinifikanti fuq il-livelli tal-glukows fid-demm.
English: Repaglinide has been given with weekly escalating doses from 4 - 20 mg four times daily in a 6 week period.
Maltese: Repaglinide ngħata b'doża miżjuda kull ġimgħa minn 4-20 mg erba' darbiet kuljum f'perijodu ta' 6 ġimgħat.
English: Iron oxide, yellow (E172)
Maltese: Maize starch Magnesium stearate Iron oxide, isfar (E172)
English: In an interaction study in healthy volunteers, co-administration of 250 mg clarithromycin, a potent mechanism based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Maltese: Fi studju dwar l-effetti ta' mediċini fuq xulxin, li sar fuq voluntiera b'saħħithom, it-teħid flimkien ma' 250 mg ta' clarithromycin, impeditur qawwi ta' CYP3A4 fuq livell ta' mekkaniżmu ta' azzjoni, żied bi ftit l-AUC ta' repaglinide b'1.4 darbiet u s-Cmax b'1.7 darbiet, u żied il-medja inkrementali ta' l-AUC ta' l-insulina fis-serum b'1.5 darbiet u l konċentrazzjoni massima b'1.6 darbiet.
English: After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min.
Maltese: Wara kura ta' 5 tijiem b'repaglinide(2 mg x 3/ġurnata) f'pazjenti b'indeboliment renali gravi (tneħħija tal-krejatinina : 20-39 ml/min) ir-riżultati wrew żieda sinifikanti li kienu ta' darbtejn iżjed fl espożizzjoni (AUC) u fil-half-life (t½), meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: In an interaction study with healthy volunteers, co-administration of clopidogrel (300 mg loading dose), a CYP2C8 inhibitor, increased repaglinide exposure (AUC0-∞) 5.1-fold and continued administration (75 mg daily dose) increased repaglinide exposure (AUC0-∞) 3.9-fold.
Maltese: F'studju ta' interazzjoni f'volontiera b'saħħithom, it-teħid flimkien ma' clopidogrel (doża ta' kkargar ta' 300 mg), inibitur ta' CYP2C8, żied l-espożizzjoni sistemika ta' repaglinide (AUC0-∞) b'5.1 darbiet u b'teħid kontinwu (doża ta' 75 mg kuljum) żied l-espożizzjoni sistemika ta' repaglinide
English: Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
Maltese: Ibla' l-pilloli ma' tazza ilma eżatt qabel jew sa 30 minuta wara kull ikla prinċipali.
English: How to store Repaglinide Teva
Maltese: Kif gћandek tieћu Repaglinide Teva
English: • Severe hepatic function disorder.
Maltese: • Disturbi severi fil-funzjoni tal-fwied.
English: In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
Maltese: Fi studju li sar fuq voluntiera b'saħħithom, l-għoti fl-istess ħin ta' repaglinide (doża waħda ta' 0.25 mg) u ciclosporin (doża ripetuta ta' 100 mg) żiedu l-AUD u Cmax b'madwar 2.5 u 1.8 darbiet rispettivament.
English: Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Maltese: Meta repaglinide (doża waħda ta' 0.25 mg) ingħata flimkien ma' gemfibrozil (600 mg darbtejn kuljum), li hu impeditur ta' CYP2C8, kien hemm żieda fl-AUC ta' repaglinide ta' 8.1 darbiet u fil-Cmax ta' 2.4 darbiet f'voluntiera b'saħħithom.
English: • If you are under 18 or over 75 years of age.
Maltese: • Jekk inti taħt it-18-il sena jew għandek aktar minn 75 sena.
English: Repaglinide is not affected by renal disorders (see section 5.2).
Maltese: Indeboliment renali Repaglinide ma jiġix affettwat minn disturbi tal-kliewi (ara sezzjoni 5.2).
English: Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil.
Maltese: Kien hemm żieda fil-half-life minn 1.3 sa 3.7 sigħat, li jirriżulta possibbilment f'effett ipogliċemizzanti ta' repaglinide aktar qawwi u aktar fit-tul, u l-konċentrazzjoni fil-plażma ta' repaglinide fis-seba' siegħa żdiedet b'28.6 darbiet bit-teħid ta'
English: Do not take Repaglinide Teva
Maltese: Mediċini oħra u Repaglinide Teva
English: Repaglinide Teva 0.5 mg tablets Each tablet contains 0.5 mg of repaglinide.
Maltese: Repaglinide Teva 0.5 mg pilloli Kull pillola fiha 0.5 mg ta' repaglinide.
English: Repaglinide is also indicated in combination with metformin in adults with type 2 diabetes mellitus who are not satisfactorily controlled on metformin alone.
Maltese: Repaglinide hu indikat ukoll f'kombinazzjoni ma' metformin f'adulti li għandhom id-dijabete mellitus tat-tip 2 li ma jiġux ikkontrollati b'metformin biss.
English: There is no reason to suspect cross-allergenicity with sulphonylurea due to the difference in chemical structure.
Maltese: Ma hemm l-ebda raġuni għalxiex għandu jkun hemm xi suspett ta' allerġija trasversali mal-mediċini tat tip sulphonylurea peress li għandhom struttura kimika differenti.
English: • Risk Management Plan (RMP) Not applicable
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli
English: Repaglinide Teva 2 mg tablets Each tablet contains 2 mg of repaglinide.
Maltese: 2 mg pilloli Kull pillola fiha 2 mg ta' repaglinide.
English: Based on in vitro data, repaglinide appears to be a substrate for active hepatic uptake (organic anion transporting protein OATP1B1).
Maltese: Skont tagħrif miġbur minn testijiet li saru in vitro, repaglinide jidher li hu sottostrat għal teħid mill-fwied (anijon organiku għat-trasport ta' proteina OATP1B1).
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide Teva 1 mg tablets Repaglinide Teva 2 mg tablets
Maltese: Repaglinide Teva Repaglinide Teva ta' 0.5 mg Pilloli ta'Repaglinide Teva 1 mg Pilloli ta'Repaglinide Teva
English: • Stomach pain
Maltese: • Remettar • Stitikezza
English: • If you take too much Repaglinide Teva.
Maltese: • Jekk tieħu wisq Repaglimide Teva.
English: Repaglinide Teva 0.5 mg tablets Light blue to blue, capsule shaped tablet, debossed with "93" on one side and “210” on the other side.
Maltese: Pillola ta' Repaglinide Teva ta' 0.5 mg hija ta' lewn kaħlani għal blu, pillola f'għamla ta' kapsula, intaljata bil-kodiċi "93" fuq naħa waħda u “210” fuq in-naħa l-oħra tal-pillola.
English: The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Maltese: Is-sinjali ta' twissija ta' ipo jistgħu jitfaċċew f'salt u jistgħu jinkludu: għaraq kiesaħ, ġilda kiesħa u pallida, uġigħ ta' ras; qalb tħabbat tgħaġġel; tħossok marid; tħossok bil-ġuħ ħafna; bidla temporanja fil-vista; ngħas; għeja mhux tas-soltu u debbulizza; nervożità jew rogħda; tħossok konfuż; diffikultà biex tikkonċentra.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 2 mg tablets Repaglinide
Maltese: Kull pillola fiha 2 mg ta' repaglinide
English: Repaglinide Teva with alcohol
Maltese: Repaglinide Teva
English: • Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
Maltese: • Sensittività eċċessiva (bħal raxx, ħakk fil-ġilda, ħmura tal-ġilda, nefħa tal-ġilda)
English: Repaglinide Teva 2 mg tablets EU/1/09/530/011-015
Maltese: EU/1/09/530/011-015
English: Repaglinide should be used with caution or be avoided in patients receiving medicinal products which influence repaglinide metabolism (see section 4.5).
Maltese: Repaglinide għandu jintuża b'kawtela jew jiġi evitat f'pazjenti li jingħataw prodotti mediċinali li jinfluwenza l-metaboliżmu ta' repaglinide (ara sezzjoni 4.5).
English: The maximum recommended daily dose is 16 mg.
Maltese: L-ogħla doża rrakkomandata ta' kuljum hi ta' 16 mg.
English: Repaglinide Teva 0.5 mg tablet is a light blue to blue, capsule shaped tablet, debossed with "93" on one side and “210” on the other side of the tablet.
Maltese: Pillola f'għamla ta' kapsula blu ċar għal blu, li fuqha hemm imnaqqxa bil-kodiċi "93" fuq naħa waħda tal-pillola u “210” fuq in-naħa l-oħra.
English: • Diarrhoea.
Maltese: gemfibrozil.
English: Repaglinide Teva 2 mg tablets Mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side.
Maltese: Pillola ta' Repaglinide Teva ta' 2 mg hija għandha dbabar ta' lewn il-ħawħ, pillola f'għamla ta' intaljata bil-kodiċi "93" fuq naħa waħda u “212” fuq in-naħa l-oħra tal-pillola.
English: Seven days pre-treatment with rifampicin (600 mg), followed by co-administration of repaglinide (a single dose of 4 mg) at day seven resulted in a 50% lower AUC (effect of a combined induction and inhibition).
Maltese: Trattament minn qabel għal sebat ijiem b'rifampicin (600 mg), segwit b'teħid konkomitanti ta' repaglinide (doża waħda ta' 4 mg) fis-seba' jum, irriżulta fi tnaqqis ta' 50% fl'AUC (effett kemm ta' sensitizzazzjoni kif ukoll ta'
English: Repaglinide Teva is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Maltese: Repaglinide Teva hu mediċina orali kontra d-dijabete li fih repaglinide li jgħin il-frixa sabiex tipproduċi aktar insulina u b'hekk jonqos il-livell ta' zokkor fid-demm (glukows) .
English: Periodic monitoring is necessary to detect inadequate lowering of blood glucose at the recommended maximum dose level (i.e. primary failure) and to detect loss of adequate blood glucose-lowering response after an initial period of effectiveness (i.e. secondary failure).
Maltese: Monitoraġġ perijodiku huwa meħtieġ sabiex jiġi magħruf l-ammont inadegwat imnaqqas ta' zokkor fil-livell massimu ta' doża rrakkomandata (i.e. insuffiċjenza primarja) u sabiex jiġi mnaqqas ir-rispons għal tnaqqis adegwat ta' zokkor wara perijodu inizjali ta' effettività (i.e. insuffiċjenza sekondarja).
English: Repaglinide Teva 1 mg tablets Each tablet contains 1 mg of repaglinide.
Maltese: Repaglinide Teva 1 mg pilloli Kull pillola fiha 1 mg ta' repaglinide.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide
Maltese: Repaglinide Teva 0.5 mg pilloli Repaglinide
English: Abnormal hepatic function, increased liver enzymes*
Maltese: Disturbi fil-fwied u fil-marrara Funzjoni epatika mhux normali, żieda fil-livelli tal enzimi tal-fwied*
English: The recommended maximum single dose is 4 mg taken with main meals.
Maltese: Id-doża singolari massima rrakkomandata hi ta' 4 mg li tingħata ma' l-ikliet prinċipali.
English: Other medicines and Repaglinide Teva
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present.
Maltese: Dan għandu jkun ibbażat fuq il-konċentrazzjonijiet tal-glukows fid-demm li jkunu mmonitorjati bir-reqqa, kemm fil-bidu tal-kura b'rifampicin (inibizzjoni akuta), kemm fid-dożi suċċessivi (taħlita ta' impediment u sensitizzazzjoni), kemm meta titwaqqaf il-kura (sensitizzazzjoni waħidha) u kif ukoll sa madwar ġimagħtejn wara li titwaqqaf il-kura b'rifampicin, meta jispiċċa l-effett induttiv ta' rifampicin .
English: Repaglinide Teva 2 mg tablet is a mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side of the tablet.
Maltese: Pillola f'għamla ta' kapsula bi dbabar ta' lewn il-ħawħ, li fuqha hemm imnaqqxa l-kodiċi "93" fuq naħa waħda tal-pillola u “212” fuq in-naħa l-oħra.
English: Repaglinide had no clinically relevant effect on the pharmacokinetic properties of digoxin, theophylline or warfarin at steady state, when administered to healthy volunteers.
Maltese: mediċini li jaġixxu kontra l-infjammazzjoni u li mhumiex sterojdi (NSAIDs), octreotide, alkoħol, u sterojdi anaboliċi.
English: • Sympathomimetics (used to treat asthma).
Maltese: • Simpatomimetiċi (użati biex tittratta l-ażma).
English: Repaglinide Teva 1 mg tablets EU/1/09/530/006-010
Maltese: EU/1/09/530/006-010
English: Combination with insulin secretagogues
Maltese: Tfal u adolexxenti
English: Refraction disorders
Maltese: Repaglinide
English: Repaglinide is almost completely metabolised, and no metabolites with clinically relevant hypoglycaemic effect have been identified.
Maltese: Repaglinide jiġi mmetabolizzat kważi kollu, u ma ġewx identifikati metaboli b'effett ipogliċemiku ta'
English: Repaglinide Teva 1 mg tablets Yellow to light yellow, capsule shaped tablet, debossed with "93" on one side and “211” on the other.
Maltese: Pillola ta' Repaglinide Teva ta' 1 mg hi ta' lewn safrani għal safrani ċar, pillola f'għamla ta' kapsula, intaljata bil-kodiċi "93" fuq naħa waħda u “211” fuq in-naħa l-oħra tal-pillola.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 1 mg tablets Repaglinide
Maltese: Kull pillola fiha 1 mg ta' repaglinide
English: The use of repaglinide might be associated with an increased incidence of acute coronary syndrome (e.g. myocardial infarction), see sections 4.8 and 5.1.
Maltese: infart mijokardjali),ara sezzjonijiet 4.8 u 5
English: 2132NP Hoofddorp The Netherlands
Maltese: 2132NP Hoofddorp L-Olanda
English: Tmax (hours)* 0.33 (0.08
Maltese: Tmax (sigħat)* 0.33 (0.08
English: Date of priming: ……….
Maltese: Data tal-prajming: ……….
English: Fentanyl may produce bradycardia.
Maltese: Fentanyl jista' jipproduċi bradikardija.
English: L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A Strada Statale 67 Tosco Romagnola, Fraz.
Maltese: Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A Strada Statale 67 Tosco Romagnola, Fraz.
English: micrograms micrograms micrograms micrograms micrograms
Maltese: mikrogramma mikrogramma mikrogramma mikrogramma mikrogramma
English: Granatieri - 50018 Scandicci (FI) Italy
Maltese: Granatieri - 50018 Scandicci (FI) L-Italja
English: Intestinal perforation Peritonitis
Maltese: Perforazzjoni intestinali Peritonite
English: This is called ‘priming'.
Maltese: Dan jissejjaħ ‘priming'.
English: Serotoninergic medicinal products:
Maltese: Prodotti mediċinali serotoninerġiċi:
English: Repeat step 5 three times.
Maltese: Irrepeti pass 5 tliet darbiet.
English: • allergic reaction, rash
Maltese: • reazzjoni allerġika, raxx
English: It is more than 90 % eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Maltese: Iktar minn 90% minnu jiġi eliminat permezz ta' bijotrasformazzjoni għal N-dealkylated u hydroxylated metaboliti inattivi.
English: [8 spray bottle:]
Maltese: [Flixkun bi 8 sprejs:]
English: Figure 2: Clinically Meaningful Pain Relief - PecFent vs placebo: % Patients' Episodes With ≥2 Point Reduction in Pain Intensity
Maltese: Figura 2: Solliev minn Uġigħ Klinikament Sinifikanti - PecFent vs plaċebo: % ta' Episodji ta' Pazjenti Bi Tnaqqis ta' ≥2 Punti fl-Intensità tal-Uġigħ
English: Cmax (pg/ml)
Maltese: Cmax (pg/ml) AUC
English: • convulsion (fits)
Maltese: • konvulżjoni (aċċessjonijiet)
English: The plasma protein binding of fentanyl is 80 - 85 %.
Maltese: It-twaħħil tal-proteini mal-plażma ta' fentanyl hu ta' 80 - 85%.
English: • medicines for depression called ‘monoamine-oxidase inhibitors' (MAOI).
Maltese: • mediċini għad-dipressjoni msejħa ‘inibituri ta' monoamine-oxidase' (MAOI).
English: 1.55 ml - 8 sprays
Maltese: 1.55 ml - 8 sprejs
English: 0.95 ml - 2 sprays 1.55 ml - 8 sprays
Maltese: 0.95 ml - 2 sprejs 1.55 ml - 8 sprejs
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Maltese: L-effetti farmakoloġiċi sekondarji huma tnaqqis respiratorju, bradikardija, ipotermija, stitikezza, mijosi, dipendenza fiżika u ewforija.
English: Date of first authorisation: 31 August 2010 Date of latest renewal: 17 July 2015
Maltese: Data tal-aħħar tiġdid: 17 Lulju 2015
English: Serotonin Syndrome
Maltese: Sindrome tas-Serotonin
English: Name and address of the manufacturer responsible for batch release L. Molteni & C dei F. LLi Alitti Societá di Esercizio S.p.A Strada Statale 67
Maltese: Molteni & C dei F. LLi Alitti Societá di Esercizio S.p.A Strada Statale 67
English: Method of titration
Maltese: Metodu ta' titrazzjoni
English: EU/1/10/644/007 100 micrograms, 2 sprays, 1 bottle EU/1/10/644/001 100 micrograms, 8 sprays, 1 bottle EU/1/10/644/002 100 micrograms, 8 sprays, 4 bottles EU/1/10/644/005 100 micrograms, 8 sprays, 12 bottles
Maltese: EU/1/10/644/007 100 mikrogramma, 2 sprejs, 1 flixkun EU/1/10/644/001 100 mikrogramma, 8 sprejs, 1 flixkun EU/1/10/644/002 100 mikrogramma, 8 sprejs, 4 fliexken EU/1/10/644/005 100 mikrogramma, 8 sprejs, 12-il flixkun
English: PecFent can deliver 100, 200, 400 and 800 microgram doses as follows:
Maltese: PecFent jista' jforni dożi ta' 100, 200, 400 u 800 mikrogrammi kif ġej:
English: EU/1/10/644/003 400 micrograms, 8 sprays, 1 bottle EU/1/10/644/004 400 micrograms, 8 sprays, 4 bottles EU/1/10/644/006 400 micrograms, 8 sprays, 12 bottles
Maltese: EU/1/10/644/003 400 mikrogramma, 8 sprejs, 1 flixkun EU/1/10/644/004 400 mikrogramma, 8 sprejs, 4 fliexken EU/1/10/644/006 400 mikrogramma, 8 sprejs, 12-il flixkun
English: Pharmacokinetic parameters (mean (%CV))
Maltese: (medja (%CV))
English: Pharmacotherapeutic group: Analgesics; opioids; phenylpiperidine derivatives; ATC code: N02AB03.
Maltese: Analġesiċi; opjojdi, derivattivi ta' phenylpiperidine; Kodiċi ATC:
English: • After the first spray, number 1 will appear in the counting window.
Maltese: • Wara l-ewwel sprej, in-numru 1 ser tidher fil-counting window.
English: Each bottle contains 1.55 ml (6,200 micrograms fentanyl)
Maltese: Kull flixkun fih 1.55 ml (6.200 mikrogrammi ta' fentanyl)
English: Propylparahydroxybenzoate (E216) Sucrose
Maltese: Phenylethyl alcohol Propyl parahydroxybenzoate (E216) Sucrose
English: Hydrochloric acid (0.36%) or sodium hydroxide (for pH adjustment) Purified water
Maltese: Hydrochloric acid 0.36% jew sodium hydroxide (għal aġġustament tal-pH)
English: The following adverse reactions have been reported with PecFent and/or other fentanyl-containing compounds during clinical studies and post marketing experience (frequencies defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu irrapportati b'PecFent u/jew komposti oħra li fihom fentanyl waqt studji kliniċi u fl-esperjenza ta' wara t-tqegħid fis-suq (frekwenzi definiti bħala komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Figure 1: Mean (± SE) Pain Intensity Scores at Each Time Point (mITT Population)
Maltese: Figura 1: Medja (± SE) ta' Punteġġi tal-Intensità tal-Uġigħ f'Kull Punt ta' Ħin (Popolazzjoni mITT)
English: E. OTFC 200 µg dose
Maltese: OTFC 200 µg dose
English: This will tilt the bottle slightly (Figure 5).
Maltese: Dan ser imejjel il-flixkun bi ftit (Figura 5).
English: Chronic pulmonary disease
Maltese: Mard pulmonari kroniku
English: In a pharmacokinetic study comparing PecFent (100, 200, 400 and 800 micrograms) with oral transmucosal fentanyl citrate (OTFC, 200 micrograms), fentanyl was shown to be rapidly absorbed following single dose intranasal administration of PecFent, with median Tmax ranging from 15 to 21 minutes (Tmax for OTFC was approximately 90 minutes).
Maltese: Assorbiment Fi studju farmakokinetiku li qabbel PecFent (100, 200, 400 u 800 mikrogramma) ma' fentanyl citrate orali transmukożali (OTFC, 200 mikrogramma), intwera li fentanyl ġie assorbit malajr wara l-għoti ta' doża waħda intranażali ta' PecFent, b'medjan tat-Tmax li varja minn 15 sa 21 minuta (Tmax għal OTFC
English: During the longer-term, open-label study (CP045) this was 6.0 % of 42,227 episodes in 355 patients treated with PecFent during up to 159 days of treatment.
Maltese: Matul l-istudju open-label (CP045) li sar fuq perjodu ta' żmien itwal dan kien ta' 6.0% minn 42,227 episodju fi 355 pazjent ikkurati b'PecFent matul sa 159 jum ta' kura.
English: Superiority was demonstrated by the primary endpoint, Pain Intensity Difference within 15 minutes, which was 3.02 in patients treated with PecFent compared to 2.69 in patients treated with IRMS (p=0.0396).
Maltese: Is superjorità ntweriet mill-punt aħħari primarju, id-Differenza ta' Intensità tal-Uġigħ fi żmien 15il minuta, li kienet ta' 3.02 f'pazjenti kkurati b'PecFent meta mqabbla ma' 2.69 f'pazjenti kkurati b'IRMS (p=0.0396).
English: • 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: Take off the clear plastic protective cap from the nozzle (Figure 1).
Maltese: Neħħi l-għatu protettiv magħmul minn plastik ċar minn fuq in-nozzle (Figura 1).
English: Fentanyl is metabolised in the liver to norfentanyl by cytochrome CYP3A4 isoform.
Maltese: Fentanyl jiġi metabolizzat fil-fwied għal norfentanyl minn isoform ta' ċitokrom CYP3A4.
English: Oral hypoaesthesia Oral paraesthesia Diarrhoea
Maltese: Ipoestesija orali Parestesija orali Dijarea
English: 1.55 ml (1,550 micrograms fentanyl) - 8 spray bottle
Maltese: 1.55 ml (1.550 mikrogrammi ta' fentanyl - Flixkun bi 8 sprejs
English: The other ingredients (excipients) are pectin (E440), mannitol (E421), phenylethyl alcohol, propylparahydroxybenzoate (E216), sucrose, purified water and hydrochloric acid or sodium hydroxide for pH adjustment.
Maltese: Is-sustanzi l-oħra (eċċipjenti) huma: pectin (E440), mannitol (E421), phenylethyl alcohol, propyl parahydroxybenzoate (E216), sucrose, ilma ppurifikat u hydrochloric acid jew sodium hydroxide għal aġġustament tal-pH.