qanastek/EMEA-V3 huggingface dataset:
Table 2 Percent of Patients Responding by Treatment Group and Phase — Cycle 1 Moderately Emetogenic Chemotherapy
Tabella 2 Perċentwal ta ’ Pazjenti Li Qed Jirrispondu skond il- Grupp ta ’ Trattament u Fażi – Ċiklu 1 Kimoterapija Moderatament Emetoġenika
433 )†%
Aprepitant (N= 433) †%
INDIVIDUAL MEASURES No Emesis (no emetic episodes regardless of use of rescue therapy)
MIŻURI INDIVIDWALI L- ebda Emesi (l- ebda episodji emetiċi bla rigward għal użu ta ’ terapija ta ’ salvataġġ)
No Significant Nausea (maximum VAS < 25 mm on a scale of 0-100 mm)
L- Ebda Nawsja Sinifikattiva (VAS massimu < 25 mm fuq skala ta ’ 0- 100 mm)
* The confidence intervals were calculated with no adjustment for age category (< 55 years, ≥ 55 years) and investigator group, which were included in the primary analysis of odds ratios and logistic models. † One patient in the Aprepitant Regimen only had data in the acute phase and was excluded from the overall and delayed phase analyses.
* L- intervalli ta ’ kunfidenza kienu ikkalkulati mingħajr l- ebda aġġustament ta ’ kategorija ta ’ età (< 55 sena, ≥55 sena) u grupp investigatur, li kienu inklużi fl- analiżi primarja ta ’ l- odds ratios u mudelli loġistiċi. † Pazjent wieħed fir- Reġimen ta ’ Aprepitant biss kellu tagħrif fil- fażi akuta u kien eskluż mill - analiżi ġenerali u tal- fażi mdewwma.
12 The estimated time to first emesis in the study is depicted by the Kaplan-Meier plot in Figure 2.
Iż- żmien stmat għall- ewwel emesi fl- analiżi ikkombinata huwa deskrit permezz tad- dijagramma Kaplan- Meier f’ Figura 2.
Figure 2 Percent of Patients Receiving Moderately Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
Figura 2 Perċentwal ta ’ Pazjenti Li Qed Jirċievu Kimoterapija Moderatament Emetoġenika Li Jibqgħu Ħielsa mill- Emesi Maż- Żmien – Ċiklu 1
100%
100 Reġimen ta ’ Aprepitant Terapija Standard 90
80% Percent of Patients
80 Perċentwal ta ’
48
Ħin
In the same clinical study, 744 patients continued into the Multiple-Cycle extension for up to 3 additional cycles of chemotherapy.
13 Fl- istess studju kliniku, 744 pazjent komplew fl- estensjoni taċ- Ċiklu Multiplu għal sa 3 ċikli addizjonali ta ’ kimoterapija.
The efficacy of the aprepitant regimen was maintained during all cycles.
L- effikaċja tar- reġimen ta ’ aprepitant kienet miżmuma waqt iċ- ċikli kollha.
Fosaprepitant, a prodrug of aprepitant, when administered intravenously is rapidly converted to aprepitant.
Fosaprepitant, promediċina ta ’ aprepitant, meta amministrat fil- vina huwa rapidament mibdul f’ aprepitant.
Plasma concentrations of fosaprepitant are below quantifiable levels within 30 minutes of the completion of infusion.
Konċentrazzjonijiet fil- plażma ta ’ fosaprepitant kienu taħt livelli li jistgħu jkunu ikkwantifikati fi żmien 30 minuta mit- tlestija ta ’ l- infużjoni.
Aprepitant after fosaprepitant administration The AUC of aprepitant following 115 mg of fosaprepitant was equivalent to the AUC of 125 mg of oral aprepitant, while Cmax was 2.5-fold higher.
Aprepitant wara amministrazzjoni ta ’ fosaprepitant L- AUC ta ’ aprepitant wara 115 mg ta ’ fosaprepitant kien ekwivalenti għall- AUC ta ’ 125 mg ta ’ aprepitant orali, waqt li Cmax kien 2. 5 drabi ogħla.
Following a single intravenous dose of fosaprepitant administered as a 15-minute infusion to healthy volunteers the mean AUC0-24hr of aprepitant was 19.8 μ g• hr/ ml and the mean maximal aprepitant concentration was 3.26 μ g/ ml.
Wara doża waħda ta ’ fosaprepitant fil- vina amministrata bħal infużjoni ta ’ 15- il minuta lil voluntiera b’ saħħithom l- AUC0- 24hr medju ta ’ aprepitant kien 19. 8 μg• hr/ ml u l- konċentrazzjoni massima ta ’ aprepitant medju kienet 3. 26 μg/ ml.
The mean aprepitant plasma concentrations from 4 hours after dosing (including the concentration at 24 hours postdose) were similar between the 125 mg oral aprepitant dose and the 115 mg intravenous fosaprepitant dose.
Il- konċentrazzjonijiet fil- plażma ta ’ aprepitant medji minn 4 sigħat wara d- doża (inkluża l- konċentrazzjoni 24 siegħa wara d- doża) kienu simili bejn doża orali ta ’ aprepitant 125 mg u d- doża fil- vina ta ’ fosaprepitant 115 mg.
Distribution Aprepitant is highly protein bound, with a mean of 97%.
Distribuzzjoni Aprepitant huwa marbut sewwa bil- proteina, b’ medja ta ’ 97%.
The geometric mean apparent volume of distribution at steady state (Vdss) is approximately 66 l in humans.
Il- medja ġeometrika tal- valur ta ’ distubuzzjoni li jidher fi stat fiss (Vdss) hija madwar 66 l fil- bnedmin.
Metabolism Fosaprepitant was rapidly converted to aprepitant in in vitro incubations with liver preparations from humans.
Metaboliżmu Fosaprepitant kien mibdul rapidament għal aprepitant f’ inkubazzjonijiet in vitro bi preparazzjonijiet tal- fwied mill- bnedmin.
Furthermore, fosaprepitant underwent rapid and nearly complete conversion to aprepitant in S9 preparations from other human tissues including kidney, lung and ileum.
Barra dan, fosaprepitant sarlu tibdil rapidu u kważi komplut għal aprepitant fi preparazzjonijiet S9 minn tessuti tal- bniedem oħra inklużi kliewi, pulmun u iljum.
Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple tissues.
Għalhekk, jidher li t- tibdil ta ’ fosaprepitant għal aprepitant jista ’ jseħħ f’ tessuti multipliċi.
In humans, fosaprepitant administered intravenously was rapidly converted to aprepitant within 30 minutes following the end of infusion.
Fil- bnedmin, fosaprepitant amministrat fil- vina kien mibdul rapidament għal aprepitant fi żmien 30 minuta wara tmiem l - infużjoni.
13 Aprepitant undergoes extensive metabolism.
Aprepitant jgħaddi minn metaboliżmu estensiv.
In healthy young adults, aprepitant accounts for approximately 19% of the radioactivity in plasma over 72 hours following a single intravenous administration 100 mg dose of [14C]-aprepitant prodrug, indicating a substantial presence of metabolites in the plasma.
F’ adulti għadhom żgħar u b’ saħħithom, aprepitant jammonta għal madwar 19% tar- radjuattività fil- plażma fuq 72- il siegħa wara amministrazzjoni ta ’ doża ta ’ 100 mg fil- vina waħda tal- promediċina [14C] - aprepitant, u dan jindika l- preżenza sostanzjali ta ’ metaboliti fil- plażma.
Twelve metabolites of aprepitant have been identified in human plasma.
Tnax- il metabolit ta ’ aprepitant ġew identifikati fil- plażma tal- bniedem.
The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Il - metaboliżmu ta ’ aprepitant iseħħ fil- parti l- kbira permezz ta ’ ossidazzjoni fiċ- ċirku morpholine u l - ktajjen tal- ġenb tiegħu u l- metaboliti li jirriżultaw kienu biss ta ’ attività dgħajfa.
In vitro studies using human liver microsomes indicate that aprepitant is metabolised primarily by CYP3A4 and potentially with minor contribution by CYP1A2 and CYP2C19.
Studji in vitro bl- użu ta ’ mikrosomi tal- fwied tal- bniedem jindikaw li aprepitant huwa metabolizzat primarjament permezz ta ’ CYP3A4 u potenzjalment b’ kontribuzzjoni minuri minn CYP1A2 u CYP2C19.
All metabolites observed in urine, faeces and plasma following an intravenous 100 mg [14C]-fosaprepitant dose were also observed following an oral dose of [14C]-aprepitant.
Il- metaboliti kollha osservati fl- awrina, ippurgar u plażma wara doża fil- vina ta ’ 100 mg [14C] - fosaprepitant kienu osservati wkoll wara doża orali ta ’ [14C] - aprepitant.
Upon conversion of 115 mg of fosaprepitant to aprepitant, 18.3 mg of phosphate is liberated from fosaprepitant.
Kif 115 mg ta ’ fosaprepitant jikkonverti għal aprepitant, 18. 3 mg ta ’ fosfat huwa illiberat minn fosaprepitant.
Elimination Aprepitant is not excreted unchanged in urine.
Eliminazzjoni Aprepitant m’ huwiex eliminat mhux mibdul fl- awrina.
Metabolites are excreted in urine and via biliary excretion in faeces.
Il- metaboliti huma eliminati fl- awrina u permezz ta ’ eliminazzjoni biljari fl- ippurgar.
Following a single intravenously administered 100 mg dose of [14C]- fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in faeces.
Wara doża waħda ta ’ 100 mg ta ’ [14C] - fosaprepitant mogħtija fil- vina, 57% tar- radjuattività kienet irkuprata mill- awrina u 45% mill- ippurgar.
The pharmacokinetics of aprepitant is non-linear across the clinical dose range.
Il- farmakokinetika ta ’ aprepitant m’ hijiex linejari matul il- medda ta ’ doża klinika.
The terminal half-life of aprepitant after oral administration ranged from approximately 9 to 13 hours.
Il- half- life terminali ta ’ aprepitant wara amministrazzjoni orali jvarja minn madwar 9 sa 13- il siegħa.
Pharmacokinetics in special populations Fosaprepitant pharmacokinetics has not been evaluated in special populations.
Farmakokinetika f’ popolazzjonijiet speċjali Il- farmakinetika ta ’ Fosaprepitant ma ġietx evalwata f’ popolazzjonijiet speċjali.
No clinically relevant differences in aprepitant pharmacokinetics is expected due to age and gender.
L- ebda differenza klinikament relevanti fil- farmakokinetika ta ’ aprepitant ma hija mistennija minħabba l- età u s- sess.
Paediatric patients:
14 Pazjenti pedjatiċi:
Fosaprepitant has not been evaluated in patients below 18 years of age.
Fosaprepitant ma ġiex evalwat f’ pazjenti taħt it- 18- il sena.
Hepatic insufficiency:
Indeboliment epatiku:
Fosaprepitant is metabolized in various extrahepatic tissues; therefore hepatic insufficiency is not expected to alter the conversion of fosaprepitant to aprepitant.
Fosaprepitant huwa metabolizzat f’ diversi tessuti ekstraepataċi; għaldaqstant indeboliment epatiku mhux mistenni li jbiddel il- konverżjoni ta ’ fosaprepitant għal aprepitant.
Mild hepatic insufficiency (Child-Pugh score 5 to 6) does not affect the pharmacokinetics of aprepitant to a clinically relevant extent.
Indeboliment epatiku ħafif (Skor Child- Pugh 5 sa 6) ma jaffettwax il- farmakokinetika ta ’ aprepitant għal xi medda kbira klinikament relevanti.
No dose adjustment is necessary for patients with mild hepatic insufficiency.
L- ebda aġġustament fid- doża ma huwa neċessarju għal pazjenti b’ indeboliment epatiku ħafif.
Conclusions regarding the influence of moderate hepatic insufficiency (Child-Pugh score 7 to 8) on aprepitant pharmacokinetics cannot be drawn from available data.
Minn dejta disponibbli ma jistgħux jinġibdu konklużjonijiet rigward l- influwenza ta ’ indeboliment epatiku moderat (Skor Child- Pugh 7 sa 8) fuq il - farmakokinetika ta ’ aprepitant.
There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Ma hemm l- ebda tagħrif kliniku jew farmakokinetiku f’ pazjenti b’ indeboliment epatiku sever (Skor Child- Pugh > 9).
Renal Insufficiency:
Indeboliment renali:
A single 240 mg dose of oral aprepitant was administered to patients with severe renal insufficiency (CrCl < 30 ml/ min) and to patients with end stage renal disease (ESRD) requiring haemodialysis.
Doża waħda ta ’ 240 mg ta ’ aprepitant orali ngħatat lil pazjenti b’ indeboliment renali sever (CrCl < 30 ml/ min) u lil pazjenti b’ mard renali ta ’ stadju finali (ESRD) li jeħtieġu emodijaliżi.
In patients with severe renal insufficiency, the AUC0-∞ of total aprepitant (unbound and protein bound) decreased by 21% and Cmax decreased by 32%, relative to healthy subjects.
F’ pazjenti b’ indeboliment renali sever, l- AUC0- ∞ ta ’ aprepitant (mhux marbut u marbut mal- proteina) naqas b’ 21% u Cmax naqas b’ 32%, fir- rigward ta ’ suġġetti b’ saħħithom.
In patients with ESRD undergoing haemodialysis, the AUC0-∞ of total aprepitant decreased by 42% and Cmax decreased by 32%.
F’ pazjenti b’ ESRD li qed issirilhom emodijaliżi, l- AUC0- ∞ ta ’ aprepitant totali naqas b’ 42% u Cmax naqas b’ 32%.
Due to modest decreases in protein binding of aprepitant in patients with renal disease, the AUC of pharmacologically active unbound aprepitant was not significantly affected in patients with renal insufficiency compared with healthy subjects.
Minħabba tnaqqis modest fl- irbit ma ’ proteina ta ’ aprepitant f’ pazjenti b’ mard renali, l- AUC ta ’ aprepitant mhux marbut farmakoloġikament attiv ma kienx effetwat b’ mod sinjifikanti f’ pazjenti b’ indeboliment renali meta mqabbla ma ’ suġġetti b’ saħħithom.
Haemodialysis conducted 4 or 48 hours after dosing had no significant effect on the pharmacokinetics of aprepitant; less than 0.2% of the dose was recovered in the dialysate.
Emodijaliżi li saret 4 jew 48 siegħa wara d- doża ma kellha l - ebda effett sinjifikanti fuq il- farmakokinetika ta ’ aprepitant; inqas minn 0. 2% tad- doża kienet irkuprata fid- dialysate.
No dose adjustment is necessary for patients with renal insufficiency or for patients with ESRD undergoing haemodialysis.
L- ebda aġġustament fid- doża ma huwa meħtieġ għal pazjenti b’ insuffiċjenza renali jew għal pazjenti b’ ESRD li qed issirilhom emodijaliżi.
Relationship between concentration and effect Fosaprepitant is a prodrug of aprepitant.
Relazzjoni bejn konċentrazzjoni u effett Fosaprepitant huwa promediċina ta ’ aprepitant.
PET imaging studies, using a highly specific NK1-receptor tracer, in healthy young men after administration of oral aprepitant have shown that aprepitant penetrates into the brain and occupies NK1 receptors in a dose-and plasma-concentration-dependent manner.
Wara amministrazzjoni ta ’ aprepitant orali, studji ta ’ l - immaġini PET, bl- użu ta ’ trejser speċifiku ħafna għar- riċettur- NK1, f’ irġiel għadhom żgħar b’ saħħithom urew li aprepitant jippenetra għal ġol- moħħ u jokkupa riċetturi NK1 b’ mod dipendenti fuq il- konċentrazzjoni tad- doża u tal- plażma.
Aprepitant plasma concentrations achieved with the 3-day regimen of oral aprepitant are predicted to provide greater than 95% occupancy of brain NK1 receptors.
Huwa mbassar li konċentrazzjonijiet ta ’ aprepitant fil - plażma li jinkisbu bir- reġimen ta ’ 3 ijiem ta ’ aprepitant orali jipprovdu aktar minn 95% okkupanza ta ’ riċetturi NK1 tal- moħħ.
The relationship between concentration and effect has not been evaluated after administration of fosaprepitant.
Ir- relazzjoni bejn konċentrazzjoni u effett ma ġietx evalwata wara amministazzjoni orali ta ’ fosaprepitant.
14 5.3 Pre-clinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
In laboratory animals, fosaprepitant in non-commercial formulations caused vascular toxicity and hemolysis at concentrations below 1 mg/ ml and higher, dependent on the formulation.
Tagħrif ta ’ qabel l- użu kliniku miksuba permezz ta ’ amministrazzjoni fil- vina ta ’ fosaprepitant u amministrazzjoni orali ta ’ aprepitant ma turi l- ebda periklu speċjali għall- bnedmin abbażi ta ’ studji konvenzjonali ta ’ tossiċità ta ’ doża waħda u repetuta, ġenotossiċità (inklużi testijiet in vitro), u tossiċità għar- riproduzzjoni, F’ annimali tal- laboratorju, fosaprepitant f’ formulazzjonijiet mhux kummerċjali kkawża tossiċità vaskulari u emoliżi f’ konċentrazzjonijiet taħt il- 1 mg/ ml u ogħla, jiddependi fuq il- formolazzjoni.
In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ ml and higher, although tests in human whole blood were negative.
F’ ċelloli umani maħsulin bid- demm instabet ukoll evidenza ta ’ emoliżi b’ formulazzjonijiet mhux kummerċjali f’ konċentrazzjonijiet ta ’ fosaprepitant ta ’ 2. 3 mg/ ml u ogħla, għalkemm it- testijiet fid- demm sħiħ uman kienu negattivi.
No hemolysis was found with the commercial formulation up to a fosaprepitant concentration of 1 mg/ ml in human whole blood and washed human erythrocytes.
Ma nstabet ebda emoliżi bil - formolazzjoni kummerċjali sa konċentrazzjoni ta ’ fosaprepitant ta ’ 1 mg/ ml f’ demm sħiħ uman u b’ eritroċiti umani maħsulin.
Carcinogenic potential in rodents was only investigated with orally administered aprepitant.
Il- potenzjal karċinoġeniku kien mistħarreġ biss b’ aprepitant amministrat oralment.
However, it should be noted that the value of the toxicity studies carried out with rodents, rabbit and monkey, including the reproduction toxicity studies, are limited since systemic exposures to fosaprepitant and aprepitant were only similar or even lower than therapeutic exposure in humans.
Madankollu, għandu jiġi innotat li espożizzjoni sistemika għal aprepitant f’ annimali gerriema kienet simili jew anke aktar baxxa mill- espożizzjoni terapewtika fil- bnedmin.
In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were 4-7 times and 60-70 times, respectively, higher than clinical values.
Fil- farmakoloġija tas- sigurtà mwettqa u fl - istudji tat- tossiċità b’ dożi ripetuti fuq il- klieb, Cmax ta ’ fosaprepitant u l- valuri AUC ta ’ aprepitant kienu 4- 7 darbiet u 60- 70 darba, rispettivament, ogħla mill- valuri kliniċi.
Disodium edetate (E386) Polysorbate 80 (E433) Lactose anhydrous Sodium hydroxide (E524) (for pH adjustment) and/ or Hydrochloric acid diluted (E507) (for pH adjustment)
Disodium edetate (E386) Polysorbate 80 (E433) Lactose anhydrous Sodium hydroxide (E524) (għal aġġustament pH) u/ jew Hydrochloric acid dilwit (E507) (għal aġġustament pH)
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6..
6. 2 Inkompatibilitajiet
After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Wara rikostituzzjoni u dilwizzjoni, l- istabbilità kimika u fiżika waqt l- użu intweriet għal 24 siegħa f’ 25°C.
From a microbiological point of view, the product should be used immediately.
Minn lat mikrobijoloġiku, il- prodott għandu jintuża minnufih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.
Jekk ma jintużax minnufih, żminijiet ta ’ ħażna waqt l- użu u kundizzjonijiet qabel l- użu huma r- responsabbilità ta ’ l- utent u normalment ma jkunux itwal minn 24 siegħa f’ 2 sa 8°C.
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħżin tal- prodott mediċinali rikostitwit u dilwit, ara s- sezzjoni 6. 3.
15 10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a blue plastic flip off cap.
Kunjett tal- ħġieġ ċar Tip I ta ’ 10 ml, tapp tal- lastiku tal- chlorobutyl jew bromobutyl u siġill ta ’ l - aluminju b’ kappa tal- plastik blu li titneħħa b’ saba ’ wieħed.
IVEMEND will be available as a pack of 1 vial of 115 mg fosaprepitant or 10 vials of 115 mg fosaprepitant.
IVEMEND se jkun magħmul disponibbli bħala pakkett ta ’ kunjett 1 ta ’ 115 mg fosaprepitant jew 10 kunjetti ta ’ 115 mg fosaprepitant.
No special requirements for disposal.
L- ebda rekwiżiti speċjali għar- rimi.
IVEMEND must be reconstituted and then diluted prior to administration.
IVEMEND għandu jiġi rikostitwit u mbagħad dilwit qabel l- amministrazzjoni.
Preparation for intravenous administration:
Preparazzjoni għal amministrazzjoni fil- vina:
Inject 5 ml sodium chloride 9 mg/ ml (0.9%) solution for injection into the vial.
Injetta 5 ml ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għal injezzjoni fil- kunjett.
Assure that sodium chloride 9 mg/ ml (0.9%) solution for injection is added to the vial along the vial wall in order to prevent foaming.
Agħmel żgur li soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għal injezzjoni tiżdied mal- ġenb tal- kunjett sabiex ma tifformax ragħwa.
Swirl the vial gently.
Ċaqlaq il- kunjett b’ ġentilezza.
Avoid shaking and jetting sodium chloride 9 mg/ ml (0.9%) solution for injection into the vial.
Evita li tħarrek u soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għal injezzjoni għal ġol- kunjett.
Prepare an infusion bag filled with 110 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection (for example, by adding 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to a 100 ml sodium chloride 9 mg/ ml (0.9%) solution for injection infusion bag).
Ipprepara borża ta ’ l- infużjoni mimlija b’ 110 ml ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għal injezzjoni (per eżempju, billi żżid 10 ml ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) ma ’ injezzjoni ta ’ 100 ml ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għal boroż ta ’ infużjoni).
Withdraw the entire volume from the vial and transfer it into an infusion bag containing 110 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection to yield a total volume of 115 ml.
Iġbed il- volum sħiħ minn ġol- kunjett u ittrasferixxih għal ġo borża ta ’ l- infużjoni li jkun fiha 110 ml ta ’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) għal injezzjoni biex tagħti volum totali ta ’ 115 ml.
Gently invert the bag 2-3 times.
Aqleb il- borża bil- mod darbtejn jew tliet darbiet.
The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).
Il- prodott mediċinali m’ għandux jiġi rikostitwit jew imħallat ma ’ soluzzjonijiet għal liema l - kompatibbiltà fiżika jew kimika ma ġietx stabbilita (ara sezzjoni 6. 2).
The appearance of the reconstituted solution is the same as the appearance of the diluent.
Id- dehra tas- soluzzjoni rikostitwita hija l- istess bħad- dehra tad- dilwent.
The medicinal product should be inspected visually for particulate matter and discoloration before administration.
Il- prodott mediċinali għandu jkun spezzjonat viżwalment għal materjal partikulat jew tindis fil- kulur qabel l- amministrazzjoni.
11 January 2008
11 Jannar 2008
DATE OF REVISION OF THE TEXT 16 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Waarderweg 39 2031 BN Haarlem 2003 PC Haarlem The Netherlands
Waarderweg 39 2031 BN Haarlem 2003 PC Haarlem L- Olanda
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3. 0 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qed taħdem qabel u waqt li l- prodott ikun fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqhom fil- verżjoni 1. 3 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. ta ’ l - Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP li jkun sar qbil fuqu mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
B’ mod konformi mal- Linja gwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi ippreżentat fl- istess żmien tar- Rapport Perjodiku ta ’ Aġġornament tas- Sigurtà (PSUR).
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, fuq il- Pjan tal- Farmakoviġilanza jew fuq l- attivitajiet ta ’ minimizzazzjoni tar- riskji Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) Fuq talba ta ’ l- EMEA
19 ANNEX III
19 ANNESS III
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON
IL- PAKKETT LI JMISS MAL- PRODOTT
IVEMEND 115 mg powder for solution for infusion Fosaprepitant dimeglumine
Fosaprepitant dimeglumine
Disodium edetate, polysorbate 80, lactose anhydrous, NaOH and/ or HCl diluted (for pH adjustment)
Disodium edetate, polysorbate 80, lactose anhydrous, NaOH u/ jew HCl dilwit (għal aġġustament tal - pH)
1 vial 10 vials 1 mg/ ml
1 kunjett 10 kunjetti 1 mg/ ml
Intravenous use after reconstitution and dilution.
Użu intravenuż wara rikostituzzjoni u dilwizzjoni.
22 After reconstitution and dilution:
22 Wara rikostituzzjoni u dilwizzjoni:
24 hours at 25°C.
24 siegħa f’ 25°C.
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Unitied Kingdom
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir- Renju Unit
EU/ 1/ 07/ 437/ 001 1 x 1 vial EU/ 1/ 07/ 437/ 002 1 x 10 vials
EU/ 1/ 07/ 437/ 001 1 x 1 kunjett EU/ 1/ 07/ 437/ 002 1 x 10 kunjetti
IVEMEND 115 mg powder for solution for infusion Fosaprepitant dimeglumine Intravenous use
IVEMEND 115 mg trab għal soluzzjoni għal infużjoni Fosaprepitant dimeglumine Użu intravenuż
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, IL- VOLUM JEW PARTI INDIVIDWALI
IVEMEND 115 mg powder for solution for infusion fosaprepitant dimeglumine
IVEMEND 115 mg trab għal soluzzjoni għal infużjoni (fosaprepitant dimeglumine)
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What IVEMEND is and what it is used for 2.
X’ inhu IVEMEND u għalxiex jintuża 2.
Before you use IVEMEND 3.
Qabel ma tuża IVEMEND 3.
How to use IVEMEND 4.
Kif għandek tuża IVEMEND 4.
How to store IVEMEND 6.
Kif taħżen IVEMEND 6.
WHAT IVEMEND IS AND WHAT IT IS USED FOR
X’ INHU IVEMEND U GĦALXIEX JINTUŻA
IVEMEND is used along with other medicines to prevent nausea and vomiting caused by chemotherapy treatment (e. g., cancer therapy).
IVEMEND jintuża flimkien ma ’ mediċini oħra biex jimpedixxi nawsja u rimettar ikkaġunati minn trattament kimoterapewtiku (eż. terapija ta ’ kontra l- kanċer).
BEFORE YOU USE IVEMEND
QABEL MA TUŻA IVEMEND
Do not use IVEMEND • If you are allergic (hypersensitive) to fosaprepitant (which is converted to aprepitant in your body), aprepitant, or to polysorbate 80 or any of the other ingredients. • With medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating gastrointestinal motility disorders).
Tużax IVEMEND • Jekk inti allerġiku (sensittiv iżżejjed) għal fosaprepitant (li jinqeleb f’ aprepitant f’ ġisemek), aprepitant, jew f’ polysorbate 80 jew għal xi sustanzi attivi l- oħra tiegħu. • Ma ’ mediċini li fihom pimozide (użat biex jittratta mard psikjatriku), terfenadine u astemizole (użati għall- hayfever jew kundizzjonijiet allerġiċi oħra), cisapride (użat biex jittratta disturbi taċ - ċaqliq gastrointestinali).
Tell your doctor if you are taking these medicines since your treatment must be modified before you start using IVEMEND.
Għid lit- tabib tiegħek jekk qed tieħu dawn il- mediċini minħabba li t - trattament tiegħek jeħtieġ li jiġi modifikat jekk tibda tuża IVEMEND.
Take special care with IVEMEND: • If you have liver disease
Oqgħod attent ħafna b ’ IVEMEND: • Jekk għandek mard tal- fwied.
Use in children and adolescents Do not give IVEMEND to patients under 18 years of age.
Użu fit- tfal u adolexxenti Tagħtix IVEMEND lil pazjenti taħt it- 18- il sena.
Using IVEMEND with other medicines IVEMEND can affect other medicines both during and after treatment with IVEMEND.
Użu ta ’ IVEMEND ma ’ mediċini oħra IVEMEND jista ’ jeffettwa mediċini oħra kemm waqt kif ukoll wara trattament b ’ IVEMEND.
There are some medicines that should not be taken with IVEMEND or that require a dose adjustment (see also Do not use IVEMEND).
Hemm xi mediċini li m’ għandhomx jittieħdu ma ’ IVEMEND jew li jeħtieġu aġġustament tad- dożaġġ (ara ukoll Tużax IVEMEND).
IVEMEND should be used with caution with many other medicines.
IVEMEND għandu jintuża bil- kawtela ma ’ mediċini oħra.
Therefore, before starting treatment, it is important that you tell your doctor about any other medicines or herbal remedies you are taking, have recently taken, or plan to take, even those obtained without a prescription.
Għaldaqstant, qabel jinbeda t- trattament, huwa importanti li tavża lit- tabib tiegħek bil- mediċini jew rimedji erbali li qed tieħu, li ħadt dan l- aħħar, jew li qed tippjana li tieħu, anke dawk li jinkisbu mingħajr riċetta tat - tabib.
Pregnancy and breast-feeding You should not use IVEMEND during pregnancy unless clearly necessary.
26 Tqala u treddigħ M’ għandekx tuża IVEMEND waqt it- tqala sakemm dan ma jkunx meħtieġ b’ mod ċar.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving IVEMEND.
Huwa importanti li tgħid lit- tabib tiegħek jekk inti tqila jew qed tippjana li toħroġ tqila qabel tirċievi IVEMEND.
26 Birth control medicines may not work when taken with IVEMEND; another form of birth control should be used during treatment with IVEMEND and for up to 2 months after using IVEMEND.
Mediċini għall- kontroll tat- twelid jistgħu ma jaħdmux meta jittieħdu ma ’ IVEMEND; waqt trattament b ’ IVEMEND u sa xahrejn wara l- użu ta ’ IVEMEND għandha tintuża forma oħra ta ’ kontroll tat - twelid.
It is not known whether IVEMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with IVEMEND.
Mhux magħruf jekk IVEMEND jiġix eliminat fil- ħalib tal- bniedem; għaldaqstant, it- treddigħ mhuwiex irrikmandat waqt trattament b ’ IVEMEND.
It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before receiving IVEMEND.
Huwa importanti li tgħid lit- tabib tiegħek jekk inti qegħda tredda ’ jew qegħda tippjana li tredda ’ qabel tirċievi IVEMEND.
Driving and using machines It should be taken into account that some people get dizzy and get sleepy after using IVEMEND.
Sewqan u tħaddim ta ’ magni Għandu jitqies li ċerti persuni jistordju u jaqbadhom in- ngħas wara li jużaw IVEMEND.
If you get dizzy or get sleepy, you should avoid driving or operating machines after using IVEMEND.
Jekk inti tistordi jew jaqbdek in- ngħas, għandek tevita li ssuq jew tħaddem magni wara li tuża IVEMEND.
(See section 4 POSSIBLE SIDE EFFECTS).
(Ara sezzjoni 4 EFFETTI SEKONDARJI POSSIBBLI).
HOW TO USE IVEMEND
KIF GĦANDEK TIEĦU IVEMEND
The recommended dose of IVEMEND is 115 mg fosaprepitant (IVEMEND) on Day 1 only of a 3-day regimen.
Id- doża irrikmandata ta ’ IVEMEND hija 115 mg fosaprepitant (IVEMEND) f’ Jum 1 biss minn reġimen ta ’ 3 ijiem.
The powder is reconstituted and diluted before use.
It- trab jiġi rikostitwit u dilwit qabel l- użu.
The solution for infusion is given via an intravenous infusion (a drip) 30 minutes before you start your chemotherapy treatment.
Is- soluzzjoni għal infużjoni tingħata permezz ta ’ infużjoni ġol- vina (drip) għal 30 minuta qabel tibda tieħu t- trattament tal- kimoterapija tiegħek.
On Days 2 and 3 following your chemotherapy treatment you will receive one 80 mg capsule of aprepitant each morning.
F’ Jiem 2 u 3 wara t- trattament tal- kimoterpaija tiegħek, inti tirċievi kapsula ta ’ 80 mg ta ’ aprepitant kull filgħodu għall- jumejn ta ’ wara t- trattament tal- kimoterapija tiegħek.
Like all medicines, IVEMEND can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, IVEMEND jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In studies, such side effects usually have been mild or moderate.
Fl- istudji, dawn l- effetti sekondarji kienu ħfief jew moderati.
Common side effects (those likely to affect between 1 and 10 patients in every 100) are: burping, constipation, diarrhoea, dizziness, weakness, tiredness, headache, hiccups, indigestion, loss of appetite, injection site pain, hardening of site of injection and increased liver enzymes.
Effetti sekondarji komuni (dawk li x’ aktarx jaffettwaw bejn pazjent 1 u 10 minn kull 100) huma: tifwiq, stitikezza, dijarea, sturdament, għeja, uġigħ ta ’ ras, sulluzzu, indiġestjoni, telf ta ’ aptit, uġigħ fis- sit ta ’ l- infezzjoni, ebusija tas- sit ta ’ l- injezzjoni u żieda fl- enzimi tal- fwied.
Uncommon side effects (those likely to affect between 1 and 10 patients in every 1,000) are: abnormal dreaming, acne, anxiousness, bacterial infection, bloating, blood in the urine, chest discomfort, cough, difficulty thinking, disorientation, dry mouth, eye discharge and itching, euphoria (feeling of extreme happiness), excessive sweating, excessive thirst, fever with increased risk of infection, fungal infection, heartburn, high sugar levels in the blood, hot flush, increased painful or burning urination, inflammation of the small intestine and colon, itching, low sodium levels in the blood, lowering of red blood cells, mucus in back of throat, muscle cramp or pain, nausea, oily skin, passing wind, presence of red blood cells in the urine, rash, reddening of the face, ringing in the ear, sensitivity to light, severe constipation, slow heartbeat, sneezing, sore throat, sores in mouth, sores on skin, stomach pain, stomach ulcer, swelling, taste disturbance, throat irritation, vomiting, and weight gain or loss.
Effetti sekondarji mhux komuni (dawk li x’ aktarx jaffettwaw bejn pazjent 1 u 10 minn kull 1, 000) huma: ħolm anormali, akne, ansjetà, infezzjoni batterika, tneffiħ, demm fl- awrina, dwejjaq fis- sider, sogħla, diffikultà fil- ħsieb, diżorjentazzjoni, ħalq xott, tisfija mill- għajnejn u ħakk, ewforija (li wieħed iħoss ferħ estrem), ħruġ eċċessiv ta ’ għaraq, għatx eċċessiv, deni biż- żieda ta ’ riskju ta ’ infezzjoni, infezzjoni fungali, ħruq ta ’ stonku, livelli ta ’ zokkor fid- demm għoljin, fwawar, żieda fl- għemil ta ’ l - awrina b’ uġigħ jew ħruq, infjammazzjoni ta ’ l- intestin iż- żgħir u l- kolon, ħakk, livelli baxxi ta ’ sodju fid- demm, tnaqqis fiċ- ċelloli l- ħomor tad- demm, mukus fuq wara tal- grieżem, bugħawwieġ jew uġigħ muskolari, nawsja, ġilda żejtnija, gass, preżenza ta ’ ċelloli tad- demm ħomor l- awrina, raxx, ħmura tal - wiċċ, tisfir fil- widna, sensittività għad- dawl, kostipazzjoni severa, taħbit bil- mod tal- qalb, għatis, uġigħ fil- grieżem, ġrieħi fil- ġilda, uġigħ fl- istonku, ulċera fl- istonku, nefħa, disturb fit- togħma, irritazzjoni fil - griżmejn, rimettar u żieda jew telf fil- piż.
Stevens-Johnson syndrome (rare severe skin reaction), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing) and urticaria (hives).
Ġew irrapportati każijiet waħdanin ta ’ dawn li ġejjin: sindromu ta ’ Stevens- Johnson (reazzjoni tal - ġilda severa rari), anġjoedima (nefħa tal- wiċċ, xofftejn, ħalq, ilsien jew gerżuma li jistgħu jikkaġunaw diffikultà biex tibla ’ jew fit- teħid tan- nifs) u urtikarja.
If any of the side effects gets serious, or if you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE IVEMEND
KIF TAĦŻEN IVEMEND
27 Do not use this medicine after the expiry date which is stated on the carton and vial.
Tużax din il- mediċina wara d- data ta 'skadenza li tidher fuq il- kartuna u fuq il- kunjett.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
L- ewwel żewġ numri jindikaw ix- xahar; l- 4 numri ta 'wara jindikaw is- sena.
The reconstituted and diluted solution is stable for 24 hours at 25°C.
Is- soluzzjoni rikostitwita u dilwita hija stabbli għal 24 siegħa f’ 25°C.
What IVEMEND contains • The active substance is fosaprepitant.
X’ fih IVEMEND • Is- sustanza attiva hija fosaprepitant.
After reconstitution 1 ml of solution contains 1 mg fosaprepitant.
Wara r- rikostituzzjoni 1 ml tas- soluzzjoni fih 1 mg ta ’ fosaprepitant.
• The other ingredients are: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (for pH adjustment) and/ or hydrochloric acid diluted (E507) (for pH adjustment).
• Is- sustanzi l- oħra huma: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (għal aġġustament tal- pH) u/ jew hydrochloric acid dilwit (E507) (għal aġġustament tal- pH).
What IVEMEND looks like and contents of the pack IVEMEND is a white to off-white powder for solution for infusion.
IVEMEND huwa trab abjad għal offwajt għal soluzzjoni għall- infużjoni.
The powder is contained in a clear glass vial with a rubber stopper and an aluminum seal with a blue plastic flip off cap.
It- trab jiġi f’ kunjett tal- ħġieġ ċar, tapp tal- lastiku tal- chlorobutyl jew bromobutyl u siġill ta ’ l- aluminju b’ kappa tal- plastik blu li titneħħa b’ saba ’ wieħed.
Not all pack sizes may be marketed.
IVEMEND se jiġi bħala pakkett ta ’ kunjett 1 jew ta ’ 10 kunjetti ta ’ fosaprepitant 115 mg Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
Hertford Road, Hoddesdon UK- Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon UK - Hertfordshire EN11 9BU Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@msd-france. com
29 France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@ msd- france. com
This leaflet was last approved in 01/ 2008
Dan il- fuljett kien l- aħħar approvat f ’ 01/ 2008
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. -----------------------------------------------------------------------------------------------------------------------------
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
Instructions of how to reconstitute and dilute IVEMEND
Struzzjonijiet fuq kif tirrikostitwixxi u tiddilwa IVEMEND
Gently invert the bag 2-3 times (see section 3 HOW TO USE IVEMEND).
Aqleb il- borża bil- mod darbtejn jew tliet darbiet (ara sezzjoni 3 KIF TUŻA IVEMEND)..
The reconstituted final solution is stable for 24 hours at 25°C.
Is- soluzzjoni finali rikostitwita hija stabbli għal 24 siegħa f’ 25°C.
Parenteral medicines should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Mediċini parenterali għandhom ikunu spezzjonati viżwalment għal materjal partikulat jew tindis fil - kulur qabel l- amministrazzjoni meta s- soluzzjoni u l- kontenitur jippermettu.
What is Jalra?
X’ inhu Jalra?
Jalra is a medicine containing the active substance vildagliptin.
Jalra huwa mediċina li fiha s- sustanza attiva vildagliptin.
This medicine is the same as Galvus, which is already authorised in the European Union (EU).
Din il- mediċina hija l- istess bħal Galvus, li huwa diġà awtorizzat fl- Unjoni Ewropea (UE).
The company that makes Galvus has agreed that its scientific data can be used for Jalra.
Il - kumpanija li tipproduċi Galvus qablet li l- informazzjoni xjentifika tagħha tista ’ tintuża għal Jalra.
What is Jalra used for?
Għal xiex jintuża Jalra?
Jalra is used to treat type 2 diabetes mellitus (non-insulin-dependent diabetes).
Jalra jintuża għat- trattament tad- dijabete mellitu tat- 2 tip (dijabete mhux dipendenti mill- insulina).
It is used together with another antidiabetes medicine (as ‘ dual therapy’) when the patient ’ s diabetes is insufficiently controlled by this other medicine taken alone.
Jintuża flimkien ma ’ mediċina oħra kontra d- dijabete (bħala ‘ terapija doppja ’) meta d- dijabete tal - pazjent ma tkunx ikkontrollata biżżejjed minn din il- mediċina l- oħra meħuda waħedha.
Jalra can be used with metformin, a thiazolidinedione or a sulphonylurea, but it is only used in combination with a sulphonylurea in patients who cannot take metformin.
Jalra jista ’ jintuża mal- metformina, thiazolidinedione jew sulfonilurea, iżda jintuża biss f’ kombinazzjoni ma ’ sulfonilurea f’ pazjenti li ma jistgħux jieħdu l- metformina.
How is Jalra used?
Kif jintuża Jalra?
In adults, the recommended dose of Jalra is:  one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione;  one tablet in the morning when taken with a sulphonylurea.
Fl- adulti, id- doża rakkomandata ta ’ Jalra hija:  pillola waħda filgħodu u oħra filgħaxija meta użata mal- metformina u ma ’ thiazolidinedione;  pillola waħda filgħodu meta tittieħed ma ’ sulfonilurea.
The daily dose should not exceed two tablets (100 mg).
Id- doża ta ’ kuljum ma għandhiex taqbeż iż- żewġ pilloli (100 mg).
Jalra can be taken with or without food.
Jalra jista 'jittieħed fuq stonku vojt jew le.
Jalra is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Jalra mhuwiex rakkomandat għal pazjenti bi problemi moderati jew gravi fil- kliewi, inkluż dawk f’ emodijaliżi (teknika ta ’ tisfija tad- demm) b’ mard renali fi stat terminali.
Jalra is not recommended for patients with liver problems.
Jalra mhuwiex rakkomandat għal pazjenti bi problemi fil- fwied.
It should be used with caution in patients aged over 75 years.
Għandu jintuża b’ kawtela f’ pazjenti ta ’ età ‘ l fuq minn 75 sena.
How does Jalra work?
Kif jaħdem Jalra?
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Id- dijabete tat- tip 2 hija marda li minħabba fiha l- frixa (pankreas) ma tipproduċix biżżejjed insulina biex tikkontrolla l- livell ta ’ glukożju (zokkor) fid- demm jew meta l- ġisem ma jkunx jista ’ juża l - insulina b’ mod effikaċi.
The active substance in Jalra, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Is- sustanza attiva f’ jalra, vildagliptin, hija inibitur tad- dipeptidil peptidażi tat - tip 4 (DPP- 4).
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Taħdem billi timblokka d- degradazzjoni tal- ormoni ‘ inkretini ’ fil- ġisem.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Dawn l - ormoni jiġu rilaxxati wara ikla u jistimulaw il- frixa biex tipproduċi l- insulina.
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Billi jżid il- livelli ta ’ ormoni ‘ inkretini ’ fid- demm, vildagliptin jistimula l- frixa biex tipproduċi aktar insulina meta l- livell ta ’ glukożju d- demm ikun għoli.
Vildagliptin does 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Vildagliptin ma jaħdimx meta l- livell ta ’ glukożju fid- demm ikun 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. not work when the blood glucose is low.
Reproduction is authorised provided the source is acknowledged. baxx.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin inaqqas ukoll l- ammont ta ’ zokkor prodott mill- fwied, billi jżid il- livelli tal- insulina u jnaqqas il- livelli tal- ormon glukagon.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Flimkien, dawn il- proċessi jnaqqsu l- livelli ta ’ glukożju fid - demm u jgħinu biex jikkontrollaw id- dijabete tat- tip 2.
How has Jalra been studied?
Kif ġie studjat Jalra?
The effects of Jalra were first tested in experimental models before being studied in humans.
L- effetti ta ’ Jalra għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fil- bniedem.
Jalra has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Jalra ġie studjat ukoll f’ seba ’ studji prinċipali li kienu jinvolvu total ta ’ aktar minn 4, 000 pazjent li jbatu mid- dijabete tat- tip 2 u b’ kontroll insuffiċjenti tal- livelli ta ’ glukożju fid- demm.
Three of these studies looked at the effects of Jalra taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
Tlieta minn dawn l- istudji analizzaw l- effetti ta ’ Jalra meta meħud waħdu f’ total ta ’ 2, 198 pazjent mhux ittrattati għad- dijabete qabel, u dan tqabbel ma ’ plaċebo (trattament finta), metformina jew rosiglitazone (thiazolidinedione).
The other four studies compared the effects of Jalra, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
L- erba ’ studji l- oħrajn qabblu l- effetti ta ’ Jalra, meħud f’ dożi ta ’ 50 jew 100 mg kuljum għal 24 ġimgħa, ma ’ dawk ta ’ plaċebo, meta użat bħala terapija addizzjonali (add- on) għat- trattament eżistenti bil- metformina (544 pazjent), pioglitazone (thiazolidinedione, 463 pazjent), glimepiride (sulfonilurea, 515- il pazjent) jew insulina (296 pazjent).
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Il- kejl ewlieni tal- effikaċja kien il- bidla fil - livelli tad- demm ta ’ sustanza msejħa emoglobina glikosilata (HbA1c - glycosylated haemoglobin), li tagħti indikazzjoni ta ’ kemm il- glukożju fid- demm huwa kkontrollat tajjeb.
What benefit has Jalra shown during the studies?
X’ benefiċċji wera Jalra fl- istudji mwettqa?
Jalra reduced levels of HbA1c in all studies.
Jalra naqqas il- livelli ta ’ HbA1c fl- istudji kollha.
When used alone, it caused a reduction in HbA1c levels by approximately 1% from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.
Meta użat waħdu, ikkawża tnaqqis fil- livelli ta ’ HbA1c ta ’ amdwar 1% mil- livell tal- bidu ta ’ madwar 8% wara 24 ġimgħa, iżda ma kienx effikaċi daqs il- metformina jew rosiglitazone.
When used as an add-on to existing treatment for type 2 diabetes, Jalra was more effective than placebo in reducing HbA1c levels.
Meta użat bħala terapija addizzjonali għat- trattament eżistenti għad- dijabete tat- tip 2, Jalra rriżulta aktar effikaċi minn plaċebo fit- tnaqqis tal- livelli ta ’ HbA1c.
With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0%.
Id- doża ta ’ kuljum ta ’ 100 mg, flimkien mal- metformina u pioglitazone, kienet aktar effikaċi mid- doża ta ’ 50 mg, bi tnaqqis tal- livelli ta ’ HbA1c bejn 0. 8% u 1. 0%.
In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6%.
Flimkien ma ’ glimepiride, iż- żewġ dożi, 50 mg u 100 mg li jittieħdu kuljum, ikkawżaw tnaqqis ta ’ madwar 0. 6%.