qanastek/EMEA-V3 huggingface dataset:
In the rasagiline clinical program overall 1361 patients were treated with rasagiline for 3076.4 patient years.
Fil- programm kliniku ta ’ rasagiline, b’ kollox 1361 pazjent irċievew trattament b’ rasagiline għal total ta ’ 3076. 4 l- sena bejn il- pazjenti kollha.
In the double blind placebo controlled studies 529 patients were treated with rasagiline 1 mg/ day for 212 patient years and 539 patients received placebo for 213 patient years.
F’ studji kliniċi double- blind ikkontrollati bil- plaċebo, 529 l - pazjent kienu trattati b’ rasagiline 1 mg/ ġurnata għal total ta ’ 212 sena bejn il- pazjenti kollha u 539 l - pazjent irċievew plaċebo għal total ta ’ 213 sena bejn il- pazjenti kollha.
Monotherapy The list below includes adverse reactions which were reported with a higher incidence in placebo- controlled studies, in patients receiving 1 mg/ day rasagiline (rasagiline group n=149, placebo group n=151).
Monoterapija Il- lista hawn taħt tinkludi reazzjonijiet avversi li kienu rrapportati b’ inċidenza ogħla f’ studji kkontrollati bil- plaċebo, f’ pazjenti li kienu jirċievu 1 mg/ ġurnata ta ’ rasagiline (grupp ta ’ rasagiline
Adverse reactions with at least 2% difference over placebo are marked in italics.
Reazzjonijiet avversi b’ inċidenza ta ’ mill- inqas differenza ta ’ 2% mill- plaċebo huma miktubin b’ italics.
In parentheses is the adverse reaction incidence (% of patients) in rasagiline vs. placebo, respectively.
Fil- parentesi hemm l- inċidenza tar- reazzjonijiet avversi (% ta ’ pazjenti) fil- grupp ta ’ rasagiline vs. dak tal- plaċebo, rispettivament.
Adverse reactions are ranked under headings of frequency using the following conventions: very common (> 1/ 10) common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10000, < 1/ 1000), very rare (< 1/ 10000) including isolated reports.
Ir- reazzjonijiet avversi huma maqsuma skond il- frekwenza permezz ta ’ dawn il- konvenzjonijiet: komuni ħafna (> 1/ 10) komuni (> 1/ 100, < 1/ 10), mhux komuni (> 1/ 1000, < 1/ 100), rari (> 1/ 10000, < 1/ 1000), rari ħafna (< 1/ 10000) inklużi rapporti iżolati.
Body as a Whole: very common: headache (14.1% vs.
Il- Ġisem Kollu Kemm Hu: komuni ħafna: uġigħ ta ’ ras (14. 1% vs.
11.9%) common: flu syndrome (6.0% vs.
11. 9%) komuni: sindrome ta ’ l - influwenza (6. 0% vs.
0%), neck pain (2.0% vs.
0. 7%), telqa mingħajr sinjali ta ’ mard (2. 0% vs.
0%), allergic reaction (1.3% vs.
0%), uġigħ fl- għonq (2. 0% vs.
1.3%) Cardiovascular system: common: angina pectoris (1.3% vs.
0%), reazzjoni allerġika (1. 3% vs 0. 7%), deni (2. 7% vs 1. 3%) Sistema Kardjovaskolari: komuni: anġina pectoris (1. 3% vs.
0%) uncommon: cerebrovascular accident (0.7% vs.
0%) mhux komuni aċċident ċerebro - vaskulari (0. 7% vs.
0%)
0%), infart mijokardijaku (0. 7% vs.
4 Digestive System: common: dyspepsia (6.7% vs.
0%) Sistema Diġestiva: komuni: dispepsja (6. 7% vs.
4%), anorexia (1.3% vs.
4%), anoressija (1. 3% vs.
0%) Haemic and lymphatic system: common: leucopenia (1.3% vs.
0%) Sistema Ematika u limfatika: komuni: lewkopenja (1. 3% vs.
0%) Musculoskeletal System: common: arthralgia (7.4% vs.
0%) Sistema Muskolu- skeletrika: komuni: artralġja (7. 4% vs.
4%), arthritis (2.0% vs.
4%), artrite (2. 0% vs.
0.7%) Nervous System: common: depression (5.4% vs.
0. 7%) Sistema Nervuża: komuni: depressjoni (5. 4% vs.
2%), vertigo (2.0% vs.
2%), vertigo (2. 0% vs.
0.7%), hallucinations (1.3% vs.
0. 7%), alluċinazzjonijiet (1. 3% vs.
1.3%) Special Senses: common: conjunctivitis (2.7% vs.
0. 7%) Sistema Respiratorja: komuni: rinite (2. 7% vs 1. 3%) Sensi Speċjali: komuni: konġuntivite (2. 7% vs.
0%), vesiculobullous rash (1.3% vs.
0. 7%) Ġilda, Riġlejn u Dirgħin: komuni: dermatite tal- kuntatt (1. 3% vs 0%),, raxx vesikulobullożu (1. 3% vs.
0%), skin carcinoma (1.3% vs.
0%), karċinoma tal- ġilda (1. 3% vs.
0.7%) Urogenital system: common: urinary urgency (1.3% vs.
0. 7%) Sistema Urinoġenitali: komuni: urġenza awrinali (1. 3% vs.
Adjunct Therapy The list below includes adverse reactions which were reported with a higher incidence in placebo- controlled studies in patients receiving 1 mg/ day rasagiline (rasagiline group n=380, placebo group n=388).
Terapija Miżjuda Il- lista ta ’ hawn taħt tinkludi reazzjonijiet avversi li kienu rrapportati b’ inċidenza ogħla f’ istudji kkontrollati bil- plaċebo, f’ pazjenti li kienu jirċievu 1 mg/ ġurnata ta ’ rasagiline (grupp ta ’ rasagiline n=380, grupp ta ’ plaċebo n=388).
Adverse reactions with at least 2% difference over placebo are in italics.
Reazzjonijiet avversi b’ inċidenza ta ’ mill- inqas differenza ta ’ 2% mill- plaċebo huma miktubin b’ italics.
Adverse reactions are ranked under headings of frequency using the following conventions: very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10000, < 1/ 1000), very rare (< 1/ 10000) including isolated reports.
Ir- reazzjonijiet avversi huma maqsuma skond il- frekwenza permezz ta ’ dawn il- konvenzjonijiet: komuni ħafna (> 1/ 10) komuni (> 1/ 100, < 1/ 10), mhux komuni (> 1/ 1000, < 1/ 100), rari (> 1/ 10000, < 1/ 1000), rari ħafna (< 1/ 10000) inklużi rapporti iżolati.
Body as a Whole: common: abdominal pain (3.9% vs.
Il- Ġisem Kollu Kemm Hu: komuni: uġigħ addominali (3. 9% vs.
1.3%), accidental injury (primarily falls) (8.2% vs.
1. 3%), korriment aċċidentali (primarjament waqgħat) (8. 2% vs.
5.2%), neck pain (1.6% vs.
5. 2%), uġigħ fl- għonq (1. 6% vs.
0.5%) Cardiovascular System: common: postural hypotension (4.7% vs.
0. 5%) Sistema Kardjo- vaskulari: komuni: pressjoni posturali baxxa (4. 7% vs.
1.3%) uncommon: angina pectoris (0.5% vs.
1. 3%) mhux komuni: anġina pectoris (0. 5% vs.
0%), cerebrovascular accident (0.5% vs.
0%), aċċident ċerebro- vaskulari (0. 5% vs.
0.3%) Digestive System: common: constipation (4.2% vs.
0. 3%) Sistema Diġestiva: komuni: stitikezza (4. 2% vs.
2.1%), vomiting (3.4% vs.
2. 1%), rimettar (3. 4% vs.
1.0%), anorexia (2.1% vs.
1. 0%) anoressija (2. 1% vs.
0.5%), dry mouth (3.4% vs.
0. 5%), ħalq xott (3. 4% vs.
1.8%) Musculoskeletal System: common: arthralgia (3.2% vs.
1. 8%) Sistema Muskolu- skeletrika: komuni: artralġja (3. 2% vs.
1.3%), tenosynovitis (1.3% vs.
1. 3%), tenosinovite (1. 3% vs.
1.5%) Nervous System: very common: dyskinesia (10.3% vs.
0%) Metabolika u Nutrizzjonali: komuni: telf ta ’ piz (4. 2% vs. 1. 5%) Sistema Nervuża: komuni ħafna: diskajneżja (10. 3% vs.
6.4%) common: dystonia (2.4% vs.
6. 4%) komuni: distownja (2. 4% vs.
0.8%), Abnormal dreams (2.1% vs.
0. 8%), ħolm abnormali (2. 1% vs 0. 8%), ataksja (1. 3% vs.
0.8%), ataxia (1.3% vs.
0. 3%), alluċinazzjonijiet (2. 9% vs.
0.3%), hallucinations (2.9% vs.
2. 1%), mhux komuni: konfużjoni (0. 8% vs.
0.8%) Skin and appendages: common: rash (2.6% vs.
Ġilda, Riġlejn u Dirgħin: komuni: raxx (2. 6% vs.
1.5%) uncommon: skin melanoma (0.5% vs.
1. 5%), mhux komuni: melanoma fil- ġilda (0. 5% vs.
Other important adverse events that were reported in clinical studies with rasagiline (other dose or in studies without placebo control) occurred in two patients each were rhabdomyolysis (both cases were following fall and prolonged immobilization) and inappropriate antidiuretic hormone (ADH) secretion.
Effetti avversi importanti oħrajn li ġew irrapportati f’ studji kliniċi b’ rasagiline (f’ dożi oħra jew fi studji mhux ikkontrollati bil- plaċebo) seħħew f’ żewġ pazjenti t- tnejn b ’ rabdomijoliżi (iż- żewġ każi kienu wara waqgħa u żmien twil ta ’ immobilita`) u sekrezzjoni mhux normali ta ’ l- ormon antidijuretiku (ADH).
The complicated nature of these cases makes it impossible to determine what role, if any, rasagiline played in their pathogenesis.
In- natura kumplikata ta ’ dawn il- każi tagħmilha impossibli li issir taf jekk kellux parti jew x’ parti kellu rasagiline fil- patoġenesi tagħhom.
Parkinson's disease is associated with symptoms of hallucinations and confusion.
5 Il- marda ta ’ Parkinson hija assoċjata ma ’ sintomi ta ’ alluċinazzjonijiet u konfużjoni.
In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
F’ esperjenza wara t- tqegħid fis- suq, dawn is- sintomi ġew osservati wkoll f’ pazjenti bil- marda ta ’ Parkinson li kienu fuq trattament b’ rasagiline.
Theoretically, overdose can cause significant inhibition of both MAO-A and MAO-B.
Tejoretikament, doża eċċessiva tista ’ tikkawża inibizzjoni sinifikanti ta ’ kemm MAO- A u MAO- B.
In a single-dose study healthy volunteers received 20 mg/ day and in a ten-day study healthy volunteers received 10 mg/ day.
F’ studji ta ’ dożi singoli, voluntiera f’ saħħithom irċievew 20 mg/ ġurnata ta ’ rasagiline u f’ studju li dam għaxart ijiem voluntieri f’ saħħithom irċievew 10 mg/ ġurnata.
Adverse events were mild or moderate and not related to rasagiline treatment.
Effetti avversi kienu ħfief jew moderati u ma kienux relatati ma ’ trattament b ’ rasagiline.
In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/ day of rasagiline, there were reports of cardiovascular undesirable effects (including hypertension and postural hypotension) which resolved following treatment discontinuation.
F’ studju fejn kienet tiżdied id- doża f’ pazjenti fuq terapija kronika b ’ levodopa li ngħataw 10 mg/ ġurnata ta ’ rasagiline, kien hemm rapporti ta ’ effetti kardjo- vaskulari mhux mixtieqa (inklużi pressjoni għolja u pressjoni posturali baxxa) li għaddew kif twaqqaf it- trattament.
These symptoms may resemble those observed with non- selective MAO inhibitors.
Dawn is- sintomi jistgħu jixbħu dawk osservati b’ impedituri mhux selettivi ta ’ MAO.
5 There is no specific antidote.
M’ hemmx antidotu speċifiku.
In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
F’ każ ta ’ doża eċċessiva, il- pazjenti għandhom jiġu osservati u jingħataw terapija sintomatika u ta ’ appoġġ.
Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors, ATC code:
Mediċini kontra l- marda ta ’ Parkinson, impedituri ta ’ monoamine oxidase – B, Kodiċi ATC:
Mechanism of action:
Il- Mod kif jaħdem:
Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an increase in extracellular levels of dopamine in the striatum.
Rasagiline kien muri li huwa impeditur selettiv ħafna u rriversibli ta ’ MAO- B, li jista ’ jikkawża żieda fil- livelli extra- ċellulari ta ’ dopamine fl- istriatum.
The elevated dopamine level and subsequent increased dopaminergic activity are likely to mediate rasagiline's beneficial effects seen in models of dopaminergic motor dysfunction.
Il- livelli għolja ta ’ dopamine u ż- żieda f’ attivita` ta ’ dopamine li tirriżulta, x’ aktarx iwasslu għall- effetti ta ’ ġid li għandu rasagiline u li dehru f’ mudelli ta ’ disfunzjoni dopaminerġika ta ’ l- moviment.
1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
1- Aminoindan, prodott attiv ewlieni tal- metabolizmu, m’ huwiex impeditur ta ’ MAO- B.
The efficacy of rasagiline was established in three studies: as monotherapy treatment in study I and as adjunct therapy to levodopa in the studies II and III.
L- effikaċja ta ’ rasagiline ġiet stabbilita fi tlett studji: bħala trattament b’ monoterapija fi studju I u bħala trattament miżjud ma ’ levodopa fi studji II u III.
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/ day (134 patients) or rasagiline 2 mg/ day (132 patients) and were treated for 26 weeks, there was no active comparator.
Ma kien hemm ebda strument attiv biex iqabbel.
In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson’ s Disease Rating Scale (UPDRS, parts I-III).
F’ dan l- istudju, il- kejl primarju ta ’ effikaċja kien it- tibdil mill- linja bażi fl- għadd ta ’ l- punti totali ta ’ l - Iskala Unifikata ta ’ Klassifika għall- Marda ta ’ Parkinson (UPDRS, partijiet I- III).
The difference between the mean change from baseline to week 26/ termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p < 0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p < 0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p < 0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Id- differenza bejn il- bidla medja mill- linja bażi sa ġimgħa 26/ tmiem (LOCF, L- Aħħar Osservazzjoni Tiġi Trasferita) kienet statistikament sinifikanti (UPDRS, partijiet I- III: għal rasagiline 1 mg imqabbel ma ’ plaċebo - 4. 2, 95% CI [- 5. 7, - 2. 7]; p < 0. 0001; għal rasagiline 2 mg mqabbel ma ’ plaċebo - 3. 6, 95% CI [- 5. 0, - 2. 1]; p < 0. 0001, UPDRS tal- moviment, parti II: għal- rasagiline 1 mg mqabbel ma ’ plaċebo - 2. 7, 95% CI [- 3. 87, - 1. 55], p < 0. 0001; għal rasagiline 2 mg meta mqabbel ma ’ plaċebo - 1. 68, 95% CI [- 2. 85, - 0. 51], p=0. 0050).
The effect was evident, although its magnitude was modest in this patient population with mild disease.
L- effett kien evidenti għalkemm modest fil- popolazzjoni ta ’ pazjenti bil- marda ħafifa.
There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Kien hemm titjib sinifikanti fil- kwalita` tal- ħajja (meta mkejjel bl- iskala PD- QUALIF).
Adjunct therapy:
6 Terapija Miżjuda:
In study II patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/ day (231 patients) or the catechol-O– methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/ decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
Damu jirċievu dan it- trattament għal 18- il ġimgħa.
In study III patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/ day (164 patients), or rasagiline 1 mg/ day (149 patients), and were treated for 26 weeks.
Fi studju III, il- pazjenti kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (159 l - pazjent), rasagiline 0. 5 mg/ ġurnata (164 l- pazjent) jew rasagiline 1 mg/ ġurnata (149 l- pazjent).
In both studies the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “ OFF” state during the day (determined from “ 24-hour ” home diaries completed for 3 days prior to each of the assessment visits).
Fiż- żewġ studji l- kejl primarju ta ’ l- effikaċja kien il- bidla fil- medja ta ’ numru ta ’ sigħat li kienu mgħoddija fi stat “ OFF ” matul il- ġurnata mill- linja bażi għall- perjodu ta ’ trattament.
In study II, the mean difference in the number of hours spent in the “ OFF” state compared to placebo was -0.78h, 95% CI [-1.18, -0.39], p=0.0001.
(Dan ġie determinat minn djarji ta ’ 24 siegħa li għamlu d- dar fit- tlett ijiem ta ’ qabel kull vista ta ’ valutazzjoni.) F’ studju II, id- differenza medja bejn in- numru ta ’ sigħat fi stat “ OFF ” meta mqabbla ma ’ plaċebo kienet ta ’ - 0. 78 sigħat, 95% CI [- 1. 18, - 0. 39], p=0. 0001.
The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p < 0.0001) to that observed in the rasagiline 1 mg group.
Il- medja ta ’ tnaqqis totali ta ’ ħin mgħoddi fi stat “ OFF ” f’ ġurnata fil- grupp ta ’ entacapone (- 0. 80 sigħat, 95% CI [- 1. 20, - 0. 41], p < 0. 0001) kien simili ta ’ dak osservat fil- grupp ta ’ rasagiline 1 mg.
In study III the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p < 0.0001.
F’ studju III, id- differenza medja meta mqabbla ma ’ plaċebo kien ta ’ - 0. 94 sigħat, 95% CI [- 1. 36, - 0. 51], p < 0. 0001.
There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Fil- grupp ta ’ rasagiline 0. 5 mg kien hemm ukoll titjib li hu statistikament sinifikanti meta mqabbel ma ’ plaċebo, imma dan l- ammont ta ’ titjib kien inqas.
The robustness of the results for the primary efficacy endpoint, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Il- qawwa tar- riżulati għall- konklużżjoni ta ’ l- effikaċja primarja kienet ikkonfermata b’ sensiela ta ’ mudelli statistiċi addizzjonali u kienet murija fi tlett cohorts (ITT, skond il- protokol u completers).
6 The secondary measures of efficacy included global assessments of improvement by the examiner, Activities of Daily Living (ADL) subscale scores when OFF and UPDRS motor while ON.
Kejl sekondarji ta ’ l- effikaċja inkludew valutazzjonijiet globali għal titjib minn eżaminatur, l- għadd ta ’ punti ta ’ l- iskala sekondarja Attivitajiet tal- Ħajja ta ’ Kuljum (ADL) meta fi stat “ OFF ” u UPDRS tal- moviment meta fi stat “ ON ”.
Rasagiline produced statistically significant benefit compared to placebo.
Rasagiline ħalla titjib li huwa statistikament sinifikanti meta mqabbel ma ’ plaċebo.
Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Rasagiline huwa assorbit malajr, u jilħaq l- ogħla konċentrazzjoni fil- plażma (Cmax) f’ bejn wieħed u ieħor 0. 5 siegħa.
The absolute bioavailability of a single rasagiline dose is about 36%.
Il- biodisponibilita` assoluta ta ’ doża waħda ta ’ rasagiline kienet ta ’ madwar 36%.
Food does not affect the Tmax of rasagiline, although Cmax and exposure (AUC) are decreased by approximately 60% and 20%, respectively, when the medicinal product is taken with a high fat meal.
L- ikel ma jkollux effett fuq Tmax ta ’ rasagiline, għalkemm Cmax u l- espożizzjoni (AUC) huma mnaqqsa b’ bejn wieħed u ieħor 60% u 20% rispettivament meta l- prodott mediċinali jittieħed ma ’ ikla b’ kontenut għoli ta ’ xaħam.
Because AUC is not substantially affected, rasagiline can be administered with or without food.
Peress li AUC mhux affetwat sostanzjalment, rasagiline jista ’ jittieħed kemm ma ’ l- ikel kif ukoll fuq stonku vojt.
The mean volume of distribution following a single intraveneous dose of rasagiline is 243 l.
Il- volum ta ’ distribuzzjoni medju wara doża waħda ta ’ rasagiline fil- vina huwa ta ’ 243 l.
Plasma protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%.
L- ammont li jeħel ma ’ l- proteini tal- plażma wara doża waħda mill- ħalq ta ’ rasagiline bit - tikketta 14C kien ta ’ bejn wieħed u ieħor 60% sa 70%.
Rasagiline undergoes almost complete biotransformation in the liver prior to excretion.
Rasagiline jiġi kważi kompletament biotrasformat fil- fwied qabel jitneħħa.
The metabolism of rasagiline proceeds through two main pathways:
Il - metaboliżmu ta ’ rasagiline jsir f’ żewġ rotot differenti:
N-dealkylation and/ or hydroxylation to yield:
N- dialkajlazzjoni u/ jew idroxilazzjoni biex jipproduċi:
1-Aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
1- Aminoindan, 3- hydroxy- N- propargyl- 1 aminoindan u 3- hydroxy- 1- aminoindan.
In vitro experiments indicate that both routes of rasagiline metabolism are dependent on cytochrome P450 system, with CYP1A2 being the major iso-enzyme involved in rasagiline metabolism.
Esperimenti in vitro juru li ż- żewġ rotot ta ’ metaboliżmu ta ’ rasagiline jiddependu fuq is- sistema ta ’ cytochrome P450, u li CYP1A2 huwa l- iżoenzim prinċipali involut fil- metaboliżmu ta ’ rasagiline.
Conjugation of rasagiline and its metabolites was also found to be a major elimination pathway to yield glucuronides.
Mod ieħor prinċipali ta ’ eliminazzjoni huwa l- konjugazzjoni ta ’ rasagiline u l- prodotti ta ’ l - metaboliżmu biex jiffurmaw glukoronidi.
After oral administration of 14C-labelled rasagiline, elimination occurred primarily via urine (62.6%) and secondarily via faeces (21.8%), with a total recovery of 84.4% of the dose over a period of 38 days.
84. 4% tad- doża kienet rikoverata fuq perjodu ta ’ 38 ġurnata.
Less than 1% of rasagiline is excreted as unchanged product in urine.
Inqas minn 1% ta ’ rasagiline ġie mneħħi bħala prodott mhux mibdul fl- awrina.
Linearity/ non-linearity:
Linearita` / non- linearita`:
Rasagiline pharmacokinetics are linear with dose over the range of 0.5-2 mg.
Il- karatteristiċi farmakokinetiċi ta ’ rasagiline huma lineari mad- doża fuq medda ta ’ 0. 5- 2 mg.
Its terminal half-life is 0.6-2 hours.
Il- half- life terminali hija ta ’ 0. 6- 2 sigħat.
Characteristics in patients
7 Karatteristiċi fil- pazjenti
In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
F’ suġġetti b’ indeboliment ħafif tal- fwied, AUC u Cmax żdiedu b ’ 80% u 38%, rispettivament.
In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
F’ suġġetti b ’ indeboliment moderat tal- fwied, AUC u Cmax żdiedu b’ 568% u 83%, rispettivament (ara sezzjoni 4. 4).
Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/ min) and moderate (CLcr 30-49 ml/ min) renal impairment were similar to healthy subjects.
Il- karatteristiċi farmakokinetiċi ta ’ rasagiline f’ suġġetti b ’ indeboliment ħafif (CLcr 50- 80 ml/ min) u b’ indeboliment moderat (CLcr 30- 49 ml/ min), kienu simili ta ’ dawk f’ suġġetti f’ saħħithom.
5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà ta ’ l- mediċina
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and reproduction toxicity.
Tagħrif ta ’ qabel l- użu kliniku magħmul fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq is- sistema riproduttiva, ma juri l- ebda periklu speċjali għall- bnedmin.
Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or hepatocytes.
Rasagiline ma kellux potenzjal għall- ġenotossiċita` in vivo u f’ bosta sistemi in vitro b’ batteri u epatoċiti.
In the presence of metabolite activation rasagiline induced an increase of chromosomal aberrations at concentrations with excessive cytotoxicity which are unattainable at the clinical conditions of use.
Meta kien hemm attivazzjoni tal- prodott tal- metaboliżmu, rasagiline ikkawża żieda f’ aberrazzjonijiet kromożomali f’ konċentazzjonijiet b’ ċitotossiċita` eċċessiva li ma jintlaħqux bil - kundizzjonijiet tal- użu kliniku.
Rasagiline was not carcinogenic in rats at systemic exposure, 84 – 339 times the expected plasma exposures in humans at 1 mg/ day.
Ma kienx hemm riskju ta ’ kanċer fil- firien f’ espożizzjoni tal- plażma 84- 339 l- darba iżjed mill - espożizzjonijiet tal- plażma mistennija fil- bniedem b’ 1 mg kuljum.
In mice, increased incidences of combined bronchiolar/ alveolar adenoma and/ or carcinoma were observed at systemic exposures, 144 - 213 times the expected plasma exposure in humans at 1 mg/ day.
Fil- ġrieden, żieda fl- inċidenza ta ’ adenoma bronkjolari/ alvejolari u/ jew karċinoma kienu osservati f’ espożizzjonijiet sistemiċi, 144 - 213 l- darba iżjed mill- espożizzjonijiet tal- plażma mistennija fil- bniedem b’ 1 mg kuljum.
Mannitol Maize starch Pregelatinised maize starch Colloidal anhydrous silica Stearic acid Talc
Mannitol Maize starch Pregelatinised maize starch Collodial anhydrous silica Stearic acid Talc
3 years Bottles:
3 snin Flixken:
Do not store above 25ºC.
Taħżinx ‘ l fuq minn 25ºC.
6.5 Nature and contents of container
6. 5 In- natura ta ’ l- kontenitur u ta ’ dak li hemm ġo fih
Aluminium/ aluminium blister packs of 7, 10, 28, 30, 100 or 112 tablets.
Aluminju/ pakketti ta ’ folji ta ’ l- aluminju ta ’ 7, 10, 28, 30, 100 jew 112 pilloli.
Bottles:
8 Flixken:
White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.
Abjad, flixkun ta ’ polyethylene ta ’ densita` għolja b’ għatu li ma jinfetaħx mit- tfal, jew mingħajr dan il- tip ta ’ għatu, li fih 30 pillola.
Teva Pharma GmbH Kandelstr 10 D-79199 Kirchzarten Germany
Teva Pharma GmbH Kandelstr 10 D- 79199 Kirchzarten Il- Ġermanja
Computerweg 10 3542 DR Utrecht THE NETHERLANDS
Computerweg 10 3542 DR Utrecht OLANDA
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta 'din l- awtorizzazzjoni għall- kummerċ għandu jagħti tagħrif lill- Kummissjoni Ewropeja dwar il- pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON FOR BLISTER PACK)
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (KAXXA TA ’ L- KARTUN GĦAL FOLJI)
AZILECT 1 mg tablets rasagiline
AZILECT 1 mg pilloli rasagiline
Each tablet contains 1 mg of rasagiline (as mesilate).
Kull pillola fiha 1 mg ta ’ rasagiline (bħala mesilate).
7, 10, 28, 30, 100, 112 tablets
7, 10, 28, 30, 100, 112 il- pillola
Teva Pharma GmbH D-79199 Kirchzarten, Germany
Teva Pharma GmbH D- 79199 Kirchzarten, Il- Ġermanja
BATCH NUMBER
NUMRU TA ’ L- LOTT
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta ta ’ t- tabib.
15 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (CARTON FOR BOTTLE) PARTICULARS TO APPEAR ON THE BOTTLE LABEL
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (KAXXA TAL- KARTUN GĦALL- FLIXKUN) TAĠHRIF LI GĦANDU JIDHER FUQ IT- TIKKETTA TAL- FLIXKUN
AZILECT 1 mg tablets Rasagiline
AZILECT 1 mg pilloli Rasagiline
What AZILECT is and what it is used for 2.
X’ inhu AZILECT u għalxiex jintuża 2.
Before you take AZILECT 3.
Qabel ma tieħu AZILECT 3.
How to take AZILECT 4.
Kif għandek tieħu AZILECT 4.
How to store AZILECT 6.
Kif taħżen AZILECT 6.
WHAT AZILECT IS AND WHAT IT IS USED FOR
X’ INHU AZILECT U GĦALXIEX JINTUŻA
AZILECT is used for the treatment of Parkinson’ s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa).
AZILECT jintuża għat- trattament tal- marda ta ’ Parkinson bħala monoterapija (mingħajr levodopa) jew bħala terapija miżjuda (ma ’ levodopa).
In Parkinson’ s disease there is a loss of cells producing dopamine in certain areas in the brain.
Fil- marda ta ’ Parkinson jkun hemm tnaqqis ta ’ ċelloli li jipproduċu dopamine f’ ċerti partijiet tal - moħħ.
AZILECT enables increased and sustained levels of dopamine in these areas.
AZILECT jwassal għal livelli ogħla u sostenuti ta ’ dopamine f’ dawn il- partijiet.
BEFORE YOU TAKE AZILECT
QABEL MA TIEĦU AZILECT
Do not take AZILECT
Tieħux AZILECT:
- if you are allergic (hypersensitive) to rasagiline or any of the other ingredients of AZILECT.
- jekk tbagħti minn allerġija (sensittività eċċessiva) għal rasagiline jew għal sustanzi oħra ta ’
- if you have a severe liver insufficiency.
- jekk int tbagħti minn insuffiċjenza tal- fwied.
Do not take monoamine oxidase (MAO) inhibitors whether used as antidepressants, for the treatment of Parkinson’ s disease, or for any other indication (including medicinal and natural products without prescription e. g.
Waqt li qed tieħu AZILECT, tieħux impedituri ta ’ monoamine oxidase (MAO) kemm jekk jintużaw għal kontra d- depressjoni, għat- trattament tal- marda ta ’ Parkinson, jew għal xi indikazzjoni oħra (inklużi prodotti mediċinali u naturali mingħajr riċetta eż.
John's Wort), while taking AZILECT.
John’ s Wort).
Do not take the strong pain killer, pethidine, while taking AZILECT.
Tieħux il- mediċina qawwija ta ’ kontra l- uġigħ, pethidine, meta tkun qed tieħu AZILECT.
You should wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Trid tistenna mill- inqas 14 il- ġurnata wara li twaqqaf it- trattament b ’ AZILECT qabel ma tibda trattament b’ impeditur ta ’ MAO jew b’ pethidine.
Take special care with AZILECT
Oqgħod attent ħafna b’ AZILECT:
- if you have mild to moderate liver insufficiency
- jekk int għandek insuffiċienza ħafifa sa moderata tal- fwied
- if you take medicines containing fluoxetine, fluvoxamine, dextromethorphan or
- jekk tieħu xi mediċina li fiha fluoxetine, fluvoxamine, dextromethorphan jew simpatomimetiċi,
sympathomimetics, please see section "Taking other medicines"
jekk jogħġbok aqra sezzjoni “ Meta tieħu mediċini oħra ”
AZILECT is not recommended for use under the age of 18.
AZILECT mhux rikkmandat għall- użu minn dawk ta ’ taħt it- tmintax il- sena.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
20 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
20 The following medicines require specific medical advice before being taken together with AZILECT:
Hemm bżonn parir mediku speċifiku qabel jittieħdu fimkien ma ’ AZILECT dawn il- mediċini li ġejjin:
Certain antidepressants (selective serotonin reuptake inhibitors, tricyclic or tetracyclic antidepressants), the antibiotic ciprofloxacin used against infections, the cough suppressant dextromethorphan, sympathomimetics such as those present in nasal and oral decongestants and cold medications containing ephedrine or pseudoephedrine.
Ċerti mediċini kontra d- depressjoni (impedituri selettivi tal- ġbir mill- ġdid ta ’ serotonin, mediċini triċikliċi u tetraċikliċi kontra d- depressjoni), l- antibijotiku ciprofloxacin li jintuża kontra l - infezzjonijiet, il- mediċina kontra s- sogħla dextromethorphan, simpatomimetiċi bħal dawk f’ dekonġestjonanti ta ’ l- imnieħer u f’ dawk li jittieħdu mill- ħalq u prodotti mediċinali kontra l- irjiħat li fihom ephedrine u pseudoephedrine.
The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
L- użu ta ’ AZILECT flimkien ma ’ mediċini kontra d- depressjoni li fihom fluoxetine u fluvoxamine għandhom jiġu evitati.
You should wait at least five weeks after stopping fluoxetine treatment and starting treatment with AZILECT.
Trid tistenna mill- inqas ħames ġimgħat minn meta twaqqaf trattament b ’ fluoxetine biex tibda trattament b ’ AZILECT.
You should wait at least 14 days after stopping AZILECT treatment and starting treatment with fluoxetine or fluvoxamine.
Trid tistenna mill- inqas 14 il- ġurnata minn meta twaqqaf AZILECT biex tibda trattament b ’ fluoxetine jew fluvoxamine.
Taking AZILECT with food and drink AZILECT may be taken with or without food.
Meta tieħu AZILECT ma ’ l- ikel u max- xorb AZILECT jista ’ jittieħed kemm ma ’ l- ikel jew mhux ma ’ l- ikel.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar l- effetti fuq il- ħila għas- sewqan jew tħaddim ta ’ magni.
HOW TO TAKE AZILECT
KIF GĦANDEK TIEĦU AZILECT
Always take AZILECT exactly as your doctor has told you.
Dejjem għandek tieħu AZILECT skond il- parir tat- tabib.
The usual dose of AZILECT is one tablet of 1 mg taken orally once daily.
Id- doża li s- soltu tingħata hija ta ’ pillola waħda ta ’ AZILECT 1 mg darba kuljum li tittieħed mill- ħalq.
If you take more AZILECT than you should
Jekk tieħu AZILECT aktar milli suppost għandek:
If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately.
Jekk taħseb li ħadt iżjed AZILECT milli suppost, għarraf lit- tabib jew lill- ispiżjar tiegħek immedjatament.
Take the AZILECT carton/ bottle with you to show the doctor or pharmacist.
Hu l- kaxxa/ flixkun ta ’ AZILECT miegħek biex turieh lit- tabib jew lill- ispiżjar.
If you forget to take AZILECT
Jekk tinsa tieħu AZILECT:
If you stop taking AZILECT
Jekk tieqaf tieħu AZILECT
Like all medicines, AZILECT can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, AZILECT jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been reported in placebo controlled clinical trials:
L- effetti sekondarji li ġejjin ġew irrapportati fi provi kliniċi kontrollati b ’:
Very common (more than 10% of the patients):
Komuni ħafna (iżjed minn 10% tal- pazjenti):
Abnormal movements (dyskinesia), headache
Movimenti abnormali (diskajneżja), uġigħ ta ’ ras
Common (between 1-10% of the patients):
21 Komuni (bejn 1- 10% tal- pazjenti):
Abdominal pain, accidental injury (primary falls), allergic reaction, fever, flu syndrome, malaise, neck pain, angina pectoris, low blood pressure when rising to a standing position (postural hypotension), anorexia, constipation, dyspepsia, dry mouth, vomiting, abnormal results of blood tests (leucopenia), joint pain (arthralgia), arthritis, tenosynovitis, weight loss, abnormal dreams, difficulty in muscular co- ordination (ataxia), depression, vertigo, prolonged muscle contractions (dystonia), rhinitis, contact dermatitis, rash, vesiculobullous rash, conjunctivitis, urinary urgency
Uġigħ addominali, korriment aċċidentali (primarjament waqgħat), reazzjoni allerġika, deni, sindromu ta ’ l- influwenza, telqa mingħajr sinjali ta ’ mard, uġigħ fl- għonq, anġina pectoris, pressjoni baxxa meta tqum bil- wieqfa (pressjoni baxxa posturali), anoressija, stitikezza, dispepsja, ħalq xott, rimettar, riżultati abnormali tad- demm (lewkopenja), uġigħ fil- ġogi (artralġja), artrite, tenosinovite, telf ta ’ piz, ħolm abnormali, diffikulta` fil- ko- ordinazzjoni muskolari (ataksja), depressjoni, vertigo, kontrazzjonijiet muskolari mtawla (distownja), rinite, dermatite tal- kuntatt, raxx, raxx vesikulobullożu, konġuntivite, urġenza awrinali
Uncommon (between 0.1-1% of the patients):
Mhux komuni (bejn 0. 1- 1% tal- pazjenti):
Stroke (cerebrovascular accident), myocardial infarct
Attakk ta ’ puplesija (aċċident ċerebro- vaskulari), infart mijokardijaku
In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Kanċer fil- ġilda ġie wkoll rappurtat f’ madwar 1% tal- pazjenti fi provi kliniċi kontrollati b’ plaċebo.
Nevertheless, scientific evidence suggests that Parkinson’ s disease, and not any drug in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Madanakollu, evidenza xjentifika tissuġerixxi li l- marda ta ’ Parkinson, u mhux xi mediċina partikolari, hija assoċjata ma ’ riskju ogħla ta ’ kanċer tal- ġilda (mhux biss melanoma).
You should speak with your doctor about any suspicious skin changes.
Għandek tkellem lit- tabib tiegħek jekk tara xi bidliet suspettużi fil- ġilda.
Parkinson's disease is associated with symptoms of hallucinations and confusion.
Il- marda ta ’ Parkinson hija assoċjata ma ’ sintomi ta ’ alluċinazzjonijiet u konfużjoni.
In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with AZILECT.
F’ esperjenza ta ’ wara t- tqegħid fis- suq is- sintomi ġew osservati wkoll f’ pazjenti bil- marda ta ’ Parkinson li kienu fuq trattament b’ rasagiline AZILECT.
HOW TO STORE AZILECT
KIF TAĦŻEN AZILECT
Do not store above 25oC.
Taħżinx ‘ l fuq minn 25ºC.
Do not use AZILECT after the expiry date which is stated on the carton, bottle or blister.
M’ għandekx tuża AZILECT wara d- data ta ’ skadenza miktuba fuq il- kartuna, il- flixkun jew il- folja.
What AZILECT contains
X’ fih AZILECT:
- The active substance is rasagiline.
Is- sustanza attiva hi rasagiline.
- The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize
Sustanzi oħra jinkludu mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.
What AZILECT looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
22 AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “ GIL” and “ 1” underneath on one side and plain on the other side.
Il- pilloli AZILECT huma bojod għal offwajt, tondi, ċatti, b’ xifer imżerżaq, mnaqqxa b ’ “ GIL ” u “ 1 ” minn taħt fuq naħa waħda u mingħajr ebda marka speċjali in- naħa l- oħra.
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.
Il- pilloli issibhom f’ folji ta ’ 7, 10, 28, 30, 100 jew 112 pilloli jew ġo flixkun ta ’ 30 pillola.
Marketing Authorisation Holder Teva Pharma GmbH Kandelstrasse 10 D-79199 Kirchzarten Germany
22 Sid l- Awtorizzazzjoni għall- Kummerċ Teva Pharma GmbH Kandelstrasse 10 D- 79199 Kirchzarten Il- Ġermanja
Manufacturer Teva Pharmaceuticals Europe B. V.
Manifattur Teva Pharmaceuticals Europe B. V.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Avenue Molière 225 B-1050 Bruxelles/ Brüssel Belgique/ Belgien Tél/ Tel: +32 2 340 2828
Avenue Molière 225 B- 1050 Bruxelles Belgique/ Belgien Tél/ Tel: +32 2 340 2828
Magyarország Biogal-Teva Pharma Zrt Rákóczi út 70-72.
Magyarország Teva Magyarország Zrt Rákóczi út 70- 72.
What is Azomyr?
X' inhu Azomyr?
Azomyr is a medicine containing the active substance desloratadine.
Azomyr hija mediċina li fiha s- sustanza attiva desloratadina (desloratadine).
It is available as a 5 mg tablet, a 5 mg oral lyophilisate (dispersible tablet), 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ ml syrup and a 0.5 mg/ ml oral solution.
Hija disponibbli bħala pillola ta '5 mg, pillola lijofilizzata (li tinħall) ta' 5 mg, u bħala pilloli li jinħallu fil- ħalq ta '2. 5 mg u 5 mg, (mistura (xropp) ta ’ 0. 5 mg/ ml u soluzzjoni orali ta' 0. 5 mg/ ml
What is Azomyr used for?
Għal xiex jintuża Azomyr?
Azomyr is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Azomyr jintuża għal serħan mis- sintomi ta 'rinite allerġika (infjammazzjoni tal- passaġġi tan- nifs ikkawżata minn allerġija, per eżempju riħ tal- ħuxlief (hay fever) jew allerġija għad- dust mites) jew urtikarja (kundizzjoni tal- ġilda kkawżata minn allerġija, b' sintomi li jinkludu ħakk u ħorriqija).
How is Azomyr used?
Kif jintuża Azomyr?
Azomyr can be taken with or without food.
Azomyr jista 'jittieħed fuq stonku vojt jew le.
How does Azomyr work?
Kif jaħdem Azomyr?
The active substance in Azomyr, desloratadine, is an antihistamine.
Is- sustanza attiva f' Azomyr, desloratadina, hija antistaminiku.
It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself.
Din taħdem billi timblokka r- riċetturi li normalment teħel magħhom l- istamina, sustanza fil- ġisem li tikkawża s- sintomi ta 'l- allerġija.
When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Meta r - riċetturi jiġu mblukkati, l- istamina ma tkunx tista 'tagħmel l- effett tagħha, u b' hekk jonqsu s- sintomi ta' l- allerġija.
How has Azomyr been studied?
Kif ġie studjat Azomyr?
Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
B' kollox saru tmien studji fuq Azomyr li fihom ħadu sehem madwar 4, 800 pazjent adult u adoloxxenti b' rinite allerġika (li kienu jinkludu erba 'studji fuq rinite allerġika staġjonali u żewġ studji f' pazjenti li kellhom ukoll l- ażma).
The effectiveness of Azomyr was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
L- effikaċja ta 'Azomyr tkejlet billi ġew studjati t- tibdiliet fis- sintomi (flissjoni, ħakk, għatis u konġestjoni ta' l- imnieħer) qabel u wara trattament ta 'ġimagħtejn jew erba' ġimgħat.
Azomyr has also been studied in 416 patients with urticaria.
Azomyr ġie studjat ukoll f' 416- il pazjent b' urtikarja.
In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment).
Fl- istudji kollha, l- effikaċja ta 'Azomyr tqabblet ma' dik ta 'plaċebo (trattament finta).
What benefit has Azomyr shown during the studies?
X' benefiċċju wera Azomyr matul l- istudji?
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Azomyr led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Fir- rinite allerġika, ir- riżultati kollha meħuda flimkien urew li trattament ta 'ġimagħtejn b' Azomyr ta' 5 mg wassal għal tnaqqis medju fil- punteġġ tas- sintomi minn 25 għal 32% meta mqabbel mat- tnaqqis minn 12 għal 26% fil- pazjenti li kienu qed jingħataw plaċebo.
In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Fiż- żewġ studji dwar l- urtikarja, wara trattament ta 'sitt ġimgħat b' Azomyr, it- tnaqqis fil- punteġġ tas- sintomi kien 58 u 67%, meta mqabbel ma' 40 u 33% f' pazjenti li kienu qed jieħdu plaċebo.
What is the risk associated with Azomyr?
X' inhu r- riskju assoċjat ma 'Azomyr?
For the full list of all side effects reported with Azomyr, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Azomyr, ara l - Fuljett ta' Tagħrif.
Azomyr should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Azomyr m' għandux jittieħed minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għad- desloratadina, il- loratadina jew għal xi sustanza oħra li tinsab f' din il- mediċina.
Why has Azomyr been approved?
Għaliex ġie approvat Azomyr?
The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr’ s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Azomyr fis- serħan mis- sintomi assoċjati mar- rinite allerġika jew ma' l- urtikarja huma akbar mir- riskji.
The Committee recommended that Azomyr be given marketing authorisation.
Il- Kumitat irrakkomanda li Azomyr jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Azomyr:
Informazzjoni oħra dwar Azomyr:
The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr to SP Europe on 15 January 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Azomyr lil SP Europe fil- 15 ta 'Jannar 2001.
The full EPAR for Azomyr is available here.
L- EPAR sħiħ dwar Azomyr jista 'jiġi kkonsultat hawn.
EU Number
Numru ta ’ l- EU EU/ 1/ 00/ 157/ 001
Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr
folji (Aclar/ PVC, alu)
EU/ 1/ 00/ 157/ 014 EU/ 1/ 00/ 157/ 015 EU/ 1/ 00/ 157/ 016 EU/ 1/ 00/ 157/ 017 EU/ 1/ 00/ 157/ 018 EU/ 1/ 00/ 157/ 019 EU/ 1/ 00/ 157/ 020 EU/ 1/ 00/ 157/ 021 EU/ 1/ 00/ 157/ 022 EU/ 1/ 00/ 157/ 023 EU/ 1/ 00/ 157/ 024 EU/ 1/ 00/ 157/ 025 EU/ 1/ 00/ 157/ 026 EU/ 1/ 00/ 157/ 027 EU/ 1/ 00/ 157/ 028 EU/ 1/ 00/ 157/ 029 EU/ 1/ 00/ 157/ 030 EU/ 1/ 00/ 157/ 031
10 pilloli
Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr
EU/ 1/ 00/ 157/ 007
0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 0.5 mg/ ml 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
Azomyr
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Lajofiliżejt orali
bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) bottle (glass) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu)
folji (Aclar/ PVC, alu)
30 ml 50 ml 60 ml 100 ml 120 ml 150 ml 225 ml 300 ml
30 pillola
1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 bottle with 1 spoon 1 2 3 5 7 10 14 15 20 21
50 pillola
1/ 3 EU/ 1/ 00/ 157/ 032 EU/ 1/ 00/ 157/ 033 EU/ 1/ 00/ 157/ 034 EU/ 1/ 00/ 157/ 035 EU/ 1/ 00/ 157/ 036 EU/ 1/ 00/ 157/ 037 EU/ 1/ 00/ 157/ 038 EU/ 1/ 00/ 157/ 039 EU/ 1/ 00/ 157/ 040 EU/ 1/ 00/ 157/ 041 EU/ 1/ 00/ 157/ 042 EU/ 1/ 00/ 157/ 043 EU/ 1/ 00/ 157/ 044 EU/ 1/ 00/ 157/ 045 EU/ 1/ 00/ 157/ 046 EU/ 1/ 00/ 157/ 047 EU/ 1/ 00/ 157/ 048 EU/ 1/ 00/ 157/ 049 EU/ 1/ 00/ 157/ 050 EU/ 1/ 00/ 157/ 051 EU/ 1/ 00/ 157/ 052 EU/ 1/ 00/ 157/ 053 EU/ 1/ 00/ 157/ 054 EU/ 1/ 00/ 157/ 055 EU/ 1/ 00/ 157/ 056 EU/ 1/ 00/ 157/ 057 EU/ 1/ 00/ 157/ 058
EU/ 1/ 00/ 157/ 013
Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr Azomyr
Azomyr
5 mg 5 mg 5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 2.5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg 5 mg
5 mg
Oral lyophilisate Oral lyophilisate Oral lyophilisate Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet Orodispersible tablet
Lajofiliżejt orali
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali
blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ Alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu) blister (PVC/ OPA/ alu)
folji (Aclar/ PVC, alu)
30 50 100 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets 5 tablets 6 tablets 10 tablets 12 tablets 15 tablets 18 tablets 20 tablets 30 tablets 50 tablets 60 tablets 90 tablets 100 tablets
100 pillola
Oral solution
Mistura
bottle (glass) + spoon (plastic)
flixkun (ħġieġ)
0.5 mg/ ml
Użu orali
Oral solution
folja (PVC/ Alu)
bottle (glass) + spoon (plastic)
flixkun (ħġieġ) + kuċċarina
Azomyr 5 mg film-coated tablets
Azomyr 5 mg pilloli miksija b’ rita
Azomyr is indicated for the relief of symptoms associated with:
Azomyr jintuża biex jittaffew is- sintomi assoċjati ma ’:
Efficacy and safety of Azomyr tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli Azomyr fi tfal taħt it- tnax- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Azomyr should be used with caution (see section 5.2).
F’ każ ta ’ insuffiċjenza renali severa, Azomyr għandu jintuża b’ attenzjoni (ara sezzjoni 5. 2).
In a clinical pharmacology trial Azomyr taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Fi prova farmakoloġika klinika, pilloli Azomyr li ttieħdu flimkien ma ’ alkoħol ma żiedux l- effetti li jxekklu l- prestazzjoni ta ’ l- alkoħol (ara sezzjoni 5. 1).
The use of Azomyr during pregnancy is therefore not recommended.
L- użu ta ’ Azomyr waqt it- tqala għaldaqstant mhuwiex irrakkomandat.