qanastek/EMEA-V3 huggingface dataset:
There is no experience with overdoses of Elaprase.
L- ebda każ ta ’ doża eċċessiva ta ’ Elaprase ma ġie rrapurtat.
Alimentary tract and metabolism products – enzymes, ATC code:
Prodotti tal- passaġġ ta ’ l- ikel u metaboliżmu – enżimi, Kodiċi ATC:
Hunter syndrome is an X-linked disease caused by insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Is- sindromu Hunter huwa marda tat- tip X- linked ikkaġunata minn livelli insuffiċjenti ta ’ l- enzima liżożomali iduronate- 2- sulfatase.
Iduronate-2-sulfatase functions to catabolize the glycosaminoglycans (GAG) dermatan sulfate and heparan sulfate by cleavage of oligosaccharide-linked sulfate moieties.
Iduronate- 2- sulfatase taħdem biex tikkatabolizza glycosaminoglycans (GAG) dermatan sulfate u heparan sulphate permezz ta ’ qsim ta ’ oligosaccharide - linked sulfate moieties.
Due to the missing or defective iduronate-2-sulfatase enzyme in patients with Hunter syndrome, glycosaminoglycans progressively accumulate in the cells, leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction.
Minħabba l- enzima iduronate- 2- sulfatase nieqsa jew difettuża f’ pazjenti bis - sindromu Hunter, il- glycoaminoglycans jakkumulaw progressivament fiċ- ċelloli, u jwasslu għal nefħa ċellolari, organomegalija, qerda tat- tessuti, u funzjoni ħażina tas- sistema ta ’ l- organi.
Idursulfase is a purified form of the lysosomal enzyme iduronate-2-sulfatase, produced in a human cell line providing a human glycosylation profile, which is analogous to the naturally occurring enzyme.
Idursulfase hija l- forma ippurifikata ta ’ l- enzima liżożomali iduronate- 2- sulfatase, magħmula f’ linja ta ’ ċellula umana li tipprovdi profil ta ’ glajkosilazzjoni umana, li hija analoga ma ’ enzima li tinstab
Idursulfase is secreted as a 525 amino acid glycoprotein and contains 8 N-linked glycosylation sites that are occupied by complex, hybrid, and high-mannose type oligosaccharide chains.
Idursulfase tiġi rilaxxata bħala 525 amino acid glycoprotein u fiha 8 siti ta ’ N- linked glycosylation li huma okkupati minn ktajjen oligosaccharide tat- tip ibridi u b’ ħafna mannose kumplessi.
Idursulfase has a molecular weight of approximately 76 kD.
Idursulfase għandu piż molekulari ta ’ madwar 76 kD.
Treatment of Hunter syndrome patients with intravenous Elaprase provides exogenous enzyme for uptake into cellular lysosomes.
Trattament intravenuż b’ Elaprase fuq pazjenti bis- sindromu Hunter jipprovdi enzima eżoġena biex tittieħed fil- liżożomi ċellolari.
Mannose-6-phosphate (M6P) residues on the oligosaccharide chains allow specific binding of the enzyme to the M6P receptors on the cell surface, leading to cellular internalization of the enzyme, targeting to intracellular lysosomes and subsequent catabolism of accumulated GAG.
Residwi ta ’ mannose- 6- phosphate (M6P) fuq il- ktajjen ta ’ oligosaccharide iħallu rbit speċifiku ta ’ l- enzima ma ’ riċetturi M6P fuq il- wiċċ taċ- ċellola, li jwassal għal internalizzazzjoni ċellolari ta ’ l- enzima, immirata għal liżożomi ċellolari u kataboliżmu sussegwenti ta ’ GAG akkumulati.
5 A total of 108 male Hunter syndrome patients with a broad spectrum of symptoms were enrolled in two randomized, placebo-controlled clinical studies, 106 continued treatment in two open-label, extension studies.
Total ta ’ 108 pazjenti bis- sindromu Hunter bi spettru wiesa ta ’ sintomi kienu inklużi f’ żewġ studji kliniċi fuq bażi każwali, ikkontrollati bi plaċebo, 106 komplew it- trattament f’ żewġ studji ta ’ estensjoni b’ tikketta mikxufa.
In a 52-week, randomized, double-blind, placebo-controlled clinical study, 96 patients between the ages of 5 and 31 years received Elaprase 0.5 mg/ kg every week (n=32) or 0.5 mg/ kg every other week (n=32), or placebo (n=32).
Fi studju kliniku ta ’ 52 ġimgħa, fuq bażi każwali, double- blind, ikkontrollat bi plaċebo, 96 pazjent ta ’ età bejn 5 u 31 sena rċievew Elaprase 0. 5 mg/ kg kull ġimgħa (n=32) jew 0. 5 mg/ kg ġimgħa iva u ġimgħa le (n=32), jew plaċebo (n=32).
The study included patients with a documented deficiency in iduronate-2- sulfatase enzyme activity, a percent predicted FVC < 80%, and a broad spectrum of disease severity.
L- istudju nkluda pazjenti b’ defiċjenza dokumentata fl- attività ta ’ l- enzima iduronate- 2- sulfatase, FVC perċentwali mbassar < 80%, u spettru wiesa ’ ta ’ serjetà tal - marda.
The primary efficacy endpoint was a two-component composite score based on the sum of the ranks of the change from baseline to the end of the study in the distance walked during six minutes (6-minute walk test or 6MWT) as a measure of endurance, and% predicted forced vital capacity (FVC) as a measure of pulmonary function.
Il- punt tat- tmiem primarju ta ’ l- effikaċja kien skor imżewwaq b’ żewġ komponenti ibbażat fuq is - somma tar- ranki tal- bidla mil- linja bażi sat- tmiem ta ’ l- istudju fid- distanza koperta matul sitt minuti (test ta ’ mixja ta ’ 6- minuti jew 6MWT) bħala miżura tal- kapaċità li wieħed jissaporti t- tbatija, u l - kapaċità% vitali sfurzata prevista (FVC) bħala miżura tal- funzjoni pulmonari.
This endpoint differed significantly from placebo for patients treated weekly (p=0.0049).
Il- punt ta ’ tmiem kien ferm differenti mill- plaċebo għal pazjenti ittrattati kull ġimgħa (p=0. 0049).
Additional clinical benefit analyses were performed on individual components of the primary endpoint composite score, absolute changes in FVC, changes in urine GAG levels, liver and spleen volumes, measurement of forced expiratory volume in 1 second (FEV1), and changes in left ventricular mass (LVM).
Saru analiżi ta ’ benefiċċju kliniku addizzjonali fuq komponenti individwali ta ’ l- iskor imżewwaq tal - punt ta ’ tmiem primarju, bidliet assoluti fl- FVC, bidliet fil- livelli ta ’ GAG awrinarji, volumi tal- fwied u l- milsa, miżura tal- volum tan- nifs sfurzat ’ il barra (FEV1), u bidliet fil- massa ventrikulari tax- xellug (LVM).
52 Weeks of Treatment 0.5 mg/ kg Weekly Endpoint
52 Ġimgħa ta ’ Trattament 0. 5 mg/ kg kull Ġimgħa
Marginally Weighted (OM) Mean (SE) Idursulfase Placebo
Mgħobbi Marġinalment (OM) Medja (SE) Idursulfase Plaċebo
Mean Treatment Difference Compared with Placebo (SE)
Valur- P (Imqabbel ma ’ Plaċebo)
P-value (Compared with Placebo)
ma ’ Plaċebo (SE)
Composite (6MWT and %FVC)
Tiżwieqa (6MWT u% FVC)
74.5 (4.5) 55.5 (4.5)
74. 5 (4. 5) 55. 5 (4. 5)
0.0049
0. 0049
6MWT (m)% Predicted FVC FVC Absolute Volume (cc)
6MWT (m)% FVC Previst Volum Assolut FVC (cc)
43.3 (9.6) 8.2 (9.6) 4.2 (1.6) -0.04 (1.6) 230.0 (40.0) 50.0 (40.0)
43. 3 (9. 6) 8. 2 (9. 6) 4. 2 (1. 6) - 0. 04 (1. 6) 230. 0 (40. 0) 50. 0 (40. 0)
35.1 (13.7) 4.3 (2.3) 190.0 (60.0)
35. 1 (13. 7) 4. 3 (2. 3) 190. 0 (60. 0)
0.0131 0.0650 0.0011
0. 0131 0. 0650 0. 0011
Urine GAG Levels (μ g GAG/ mg creatinine)
Livelli ta ’ GAG fl - awrina (μg GAG/ mg kreatinin)
-223.3 (20.7) 52.23 (20.7)
- 223. 3 (20. 7) 52. 23 (20. 7)
-275.5 (30.1)
- 275. 5 (30. 1)
% Change in Liver Volume
% Bidla fil- Volum tal- Fwied
-25.7 (1.5) -0.5 (1.6)
- 25. 7 (1. 5) - 0. 5 (1. 6)
-25.2 (2.2)
- 25. 2 (2. 2)
% Change in Spleen Volume
% Bidla fil- Volum tal- Milsa
-25.5 (3.3) 7.7 (3.4)
- 25. 5 (3. 3) 7. 7 (3. 4)
-33.2 (4.8)
- 33. 2 (4. 8)
A total of 11 of 31 (36%) patients in the weekly treatment group versus 5 of 31 (16%) patients in the placebo group had an increase in FEV1 of at least 200 cc at or before the end of the study, indicating a dose-related improvement in airway obstruction.
Total ta ’ 11- il pazjent minn 31 (36%) fil- grupp ta ’ trattament ta ’ kull ġimgħa kontra 5 pazjenti minn 31 (16%) fil- grupp tal- plaċebo kellhom żieda fl- FEV1 ta ’ mill- inqas 200 cc fi jew qabel tmiem l - istudju, u dan jindika titjib kontra l- imblokkar tal- passaġġ ta ’ l- arja relatat mad- doża.
The patients in the weekly treatment group experienced a clinically significant 15% mean improvement in FEV1 at the end of the study.
Il- pazjenti fil - grupp ta ’ trattament ta ’ kull ġimgħa esperjenzaw titjib medju ta ’ 15% klinikament sinifikattiv f’ FEV1 fit- tmiem ta ’ l- istudju.
Urine GAG levels were normalized below the upper limit of normal (defined as 126.6 µg GAG/ mg creatinine) in 50% of the patients receiving weekly treatment.
6 Livelli ta ’ GAG fl- awrina kienu innormalizzati taħt il- limitu ta ’ fuq tan- normal (iddefiniti bħala 126. 6 µg GAG/ mg kreatinin) f’ 50% tal- pazjenti li jirċievu trattament ta ’ kull ġimgħa.
Of the 25 patients with abnormally large livers at baseline in the weekly treatment group, 80% (20 patients) had reductions in liver volume to within the normal range by the end of the study.
Mill- 25 pazjent bi fwied kbir b’ mod anormali fil- linja bażi fil- grupp ta ’ trattament ta ’ kull ġimgħa, 80% (20 pazjent) kellhom tnaqqis fil- volum tal- fwied fi ħdan il- medda normali sa tmiem l- istudju.
6 Of the 9 patients in the weekly treatment group with abnormally large spleens at baseline, 3 had spleen volumes that normalized by the end of the study.
Mid- 9 pazjenti b’ milsiet kbar b’ mod anormali fil- linja bażi fil- grupp ta ’ trattament ta ’ kull ġimgħa, 3 kellhom volumi tal- milsa li innormalizzaw sa tmiem l- istudju.
Approximately half of the patients in the weekly treatment group (15 of 32; 47%) had left ventricular hypertrophy at baseline, defined as LVM index > 103 g/ m2.
Bejn wieħed u ieħor nofs il- pazjenti fil- grupp ta ’ trattament ta ’ kull ġimgħa (15 minn 32; 47%) kellhom ipertrofija ventrikulari xellugija fil- linja bażi, iddefinita bħal indiċi LVM > 103 g/ m2.
Of these 6 (40%) had normalised LVM by the end of the study.
Minn dawn 6 (40%) kellhom LVM innormalizzat sa tmiem l- istudju.
No clinical data exist demonstrating a benefit on the neurological manifestations of the disorder.
Ma jeżisti l- ebda tagħrif kliniku li juri benefiċċju fuq il- manifestazzjonijiet newroloġiċi tad- disturb.
This medicinal product has been authorised under “ Exceptional Circumstances”.
Dan il- prodott mediċinali ġie awtorizzat taħt “ Ċirkostanzi ta ’ Eċċezzjoni ”.
The European Medicines Agency (EMEA) will review any new information which may become available every year and this SPC will be updated as necessary.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari ma kienx possibbli li tinkiseb informazzjoni kompleta dwar il- benefiċċji u r- riskji ta ’ dan il- prodott mediċinali L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u ser taġġorna dan is- Sommarju tal- Karatteristiċi tal- Prodott, skond il- bżonn.
Idursulfase is taken up by selective receptor-mediated mechanisms involving binding to mannose 6- phosphate receptors.
Idursulfase jittieħed permezz ta ’ mekkaniżmi selettivi medjati mir- riċetturi li jinvolvu rbit ma ’ riċetturi ta ’ mannose 6- phosphate.
Upon internalization by cells, it is localized within cellular lysosomes, thereby limiting distribution of the protein.
Jiġi lokalizzat fi ħdan il- liżożomi ċellolari, malli ssir internalizzazzjoni miċ - ċelloli, u b’ hekk tillimita d- distribuzzjoni tal- proteina.
Degradation of idursulfase is achieved by generally well understood protein hydrolysis mechanisms to produce small peptides and amino acids, consequently renal and liver function impairment is not expected to affect the pharmacokinetics of idursulfase.
Degradazzjoni ta ’ idursulfase tinkiseb permezz ta ’ mekkaniżmi mifhuma sewwa ta ’ idroliżi tal- proteina biex jipproduċu peptidi u aċidi amino, konsegwentemant funzjoni indebolita renali u tal- fwied mhix mistennija li taffettwa il- farmakokinetiċi ta ’ idursulfase.
Pharmacokinetics was evaluated in 10 patients at Week 1 and Week 27 following administration of 0.5 mg/ kg weekly as a 3-hour infusion.
Il- farmakokinetiċi kienu evalwati f’ 10 pazjenti f’ Ġimgħa 1 u f’ Ġimgħa 27 wara l- amministrazzjoni ta ’ 0. 5 mg/ kg kull ġimgħa bħala infużjoni ta ’ 3 sigħat.
There were no differences in pharmacokinetic parameters following 27 weeks of treatment.
Ma kien hemm l- ebda differenza fil- parametri farmakokinetiċi wara 27 ġimgħa ta ’ trattament.
Week 1 (SD) 1.5 (0.6)
Ġimgħa 1 (SD) 1. 5 (0. 6)
Week 27 (SD) 1.1 (0.3)
Ġimgħa 27 (SD) 1. 1 (0. 3)
AUC (min* μ g/ ml) T1/ 2 (min)
AUC (min * μg/ ml) T1/ 2 (min) Cl (ml/ min/ kg) Vss (% BW)
206 (87) 44 (19)
206 (87) 44 (19) 3. 0 (1. 2) 21 (8)
169 (55) 48 (21)
169 (55) 48 (21) 3. 40 (1. 0) 25 (9)
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and male fertility.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku ta ’ doża waħda, effett tossiku minn dożi ripetuti, u fertilità tar- raġel, ma turi l- ebda periklu speċjali għall- bnedmin.
No reproductive toxicity studies in female animals have been performed.
Ma sar l- ebda studju fuq it- tossiċità riproduttiva f’ annimali nisa.
Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Water for Injections
7 Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Ilma għal injezzjonijiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
7 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
2 years Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Stabbiltà kimika u fiżika ta ’ waqt l- użu ġiet murija għal 8 sigħat f’ 25°C.
From a microbiological safety point of view, the diluted product should be used immediately.
Mil- lat ta ’ sigurtà mikrobijoloġika, il- prodott dilwit għandu jintuża minnufih.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.
Jekk ma jintużax minnufih, iż- żminijiet u l- kondizzjonijiet ta ’ waqt l- użu huma r- responsabbiltà ta ’ l- utent u m’ għandhomx ikunu itwal minn 24 siegħa fi 2 sa 8°C.
For storage conditions of the diluted medicinal product, see section 6.3.
Għall- kondizzjonijiet ta ’ ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
3 ml of concentrate for solution for infusion in a 5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flip-off cap.
3 ml ta ’ konċentrat għal soluzzjoni għal infużjoni f’ kunjett ta ’ 5 ml (ħġieġ tip I) b’ tapp (lastiku butyl miksi bi fluoro- resin), siġill f’ biċċa waħda u kappa blu li titneħħa b’ saba ’ wieħed.
Pack sizes of 1, 4 and 10 vials.
Daqsijiet tal- pakkett ta ’ 1, 4 u10 kunjetti.
Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution.
Kull kunjett ta ’ Elaprase huwa intenzjonat sabiex jintuża darba biss u fih 6 mg ta ’ idursulfase f’ soluzzjoni ta ’ 3 ml.
Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ ml (0.9%) solution for infusion prior to use.
Elaprase huwa għal infużjoni intravenuża u għandu jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) qabel l- użu.
- Determine the number of vials to be diluted based on the individual patient’ s weight and the
- Stabbilixxi n- numru ta ’ kunjetti li jridu jiġu dilwiti fuq il- piż tal- pazjent individwali u d- doża
recommended dose of 0.5 mg/ kg.
irrikmandata ta ’ 0. 5 mg/ kg.
Do not
- Tużax is- soluzzjoni fil- kunjetti jekk din tkun ta ’ kulur imdennes jew jekk ikun fiha materjal
shake.
imfarrak.
- Withdraw the calculated volume of Elaprase from the appropriate number of vials.
- Iġbed il- volum ikkalkulat ta ’ Elaprase minn numru xieraq ta ’ kunjetti.
- Dilute the total volume required of Elaprase in 100 ml of 9 mg/ ml (0.9%) sodium chloride solution
- Iddilwa l- volum totali meħtieġ ta ’ Elaprase f’ 100 ml ta ’ 9 mg/ ml (0. 9%) soluzzjoni ta ’ sodium
for infusion.
chloride għal infużjoni.
Care must be taken to ensure the sterility of the prepared solutions since Elaprase does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Għandha tintuża l- kawtela biex tiġi żgurata l- isterilità tas- soluzzjoni ippreparata minħabba li Elaprase ma fihx preservattiv jew mediċina batterjostatika; għandha tiġi osservata teknika asettika.
Once diluted, the solution should be mixed gently, but not shaken.
Ġa la darba dilwita, is- soluzzjoni għandha titħallat bil- mod, mingħajr ma titħarrek.
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Sweden
8 Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, L- Isvezja
DATE OF REVISION OF THE TEXT
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ Ċ.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Shire (TK3) 205 Alewife Brook Parkway Cambridge, MA 02138 USA
Shire (TK3) 205 Alewife Brook Parkway Cambridge, MA 02138 L- Istati Uniti
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Shire Human Genetic Therapies AB Åldermansgatan 2, Box 1117, 221 04 Lund Sweden
Shire Human Genetic Therapies AB Åldermansgatan 2, Box 1117, 221 04 Lund L- Iżvezja
Summary of Product Characteristics, 4.2).
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni 4. 2).
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 03 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.
Sistema ta ’ farmakoviġilanza Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 03, ippreżentata fil- Modulu 1. 8. 1 tal- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l - prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 02, 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.
Pjan ta ’ Ġestjoni tar- Riskju Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqu fil- verżjoni 02 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ippreżentat fil- Modulu 1. 8. 2. tal- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u għal kwalunkwe aġġornament sussegwenti tal- RMP li jsir qbil fuqu mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Skond il- Linja gwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin tar- Rapport Perjodiku ta ’ Aġġornament dwar is- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted * 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.
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat * Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji attwali * Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) ”.
11 C.
11 * Fuq talba tal- EMEA.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI TAD- DETENTUR TA ’ AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
Clinical aspects
Aspetti kimiċi
To carry out the planned Immunogenicity and Specific Sub-Population (Under 5 years) studies with the following proposed timelines.
Li jsiru l- istudji ppjanati dwar l- Immunoġeniċità u s- Sub- Popolazzjoni Speċifika (Taħt il- 5 snin) bl- iskadenzi proposti li ġejjin.
HOS Final Protocol Available Patient Enrolment Analysis of Data Immunogenicity Sub-study
Protokoll Finali Disponibbli Ingaġġar tal- Pazjenti Analiżi finali tat- Tagħrif
Complete Underway At annual reassessment
Substudju ta ’ l- Immunoġeniċità
Final Protocol Available Patient Enrolment Final analysis of Data Under 5 years Sub-Study
Sub- studju taħt il- 5 snin
Final Protocol Available Patient Enrolment Final analysis of Data
Protokoll Finali Disponibbli Ingaġġar tal- Pazjenti Analiżi finali tat- Tagħrif
Complete Underway 30.11.2010
Sħiħ Qegħda ssir 30. 11. 2010
To submit data regarding immunogenicity after re-exposure to idursulfase within the Annual PSURs.
Li tiġi ppreżentata dejta rigward l- immunoġeniċità wara espożizzjoni mill- ġdid għall- idursulface fil- PSURs Annwali.
To evaluate the following long term clinical endpoints primarily through the HOS.
Li ssir evalwazzjoni ta ’ l- endpoints kliniċi fuq perjodu ta ’ żmien twil li ġejjin primarjament permezz ta ’ l- HOS.
These data will be re-evaluated annually and outcomes reported and discussed within the Annual Reassessments.
Dan it- tagħrif sejjer jiġi vvalutat mill- ġdid kull sena u r- riżultati jiġu rrapportati u diskussi fil- Valutazzjonijiet Annwali mill- Ġdid.
status) and mortality
Valutazzjoni tal- morbidità pulmonari fuq perjodu ta ’ żmien twil (eż., inċidenza ta ’ infezzjonijiet, status tal- funzjoni pulmonari) u mortalità
echocardiography data, where available) and mortality
Valutazzjoni tal- morbidità kardjovaskulari fuq perjodu ta ’ żmien twil (eż., inċidenza ta ’ l- episodji u tagħrif ekokardijaku, meta disponibbli) u mortalità
- Assessment of long term antibody levels, isotype and correlation to other therapeutic parameters
Valutazzjoni ta ’ modi ta ’ GAG excretion awrinarju fuq perjodu ta ’ żmien twil Valutazzjoni fuq perjodu ta ’ żmien twil ta ’ livelli ta ’ antikorpi, isotip u korrelazzjoni ma ’ parametri terapewtiċi oħrajn
OUTER CARTON / 1, 4, 10 VIAL
KARTUNA TA ’ BARRA / 1, 4, 10 KUNETTI
Elaprase 2 mg/ ml concentrate for solution for infusion Idursulfase
Elaprase 2 mg/ ml konċentrat għal soluzzjoni għal infużjoni Idursulfase
Each vial contains 6 mg of idursulfase Each ml contains 2 mg of idursulfase
Kull ml fih 2 mg ta ’ idursulfase
Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Water for Injections
Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Ilma għall- injezzjonijiet
1 vial [4, 10 vials] of 3 ml concentrate for solution for infusion
1 kunjett [4, 10 kunjetti] ta ’ 3 ml konċentrat għal soluzzjoni għal infużjoni
Intravenous use For single use only Read the enclosed package leaflet before use
Użu għal ġol- vini Għal użu ta ’ darba biss Aqra l- fuljett ta ’ tagħrif qabel l- użu
{MMM/ YYYY}
{XXX/ SSSS}
Store in a refrigerator Do not freeze
Aħżen fi friġġ Tagħmlux fil- friża
Any unused product or waste material should be disposed of in accordance with local requirements 15 11.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Sweden
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, L- Isvezja
Not Applicable.
Mhux applikabbli.
In accordance with the Guidance concerning the Braille requirements for labelling and the package leaflet; there is no need to put Braille on the packaging of products which are only intended for administration by healthcare professionals, as is the case for Elaprase.
Skond il- Gwida dwar ir- rekwiżiti tal- Braille għat- tikketta u l- fuljett ta ’ tagħrif, ma hemm ebda ħtieġa li l- Braille jitpoġġa fuq il- pakkett tal- prodotti li huma maħsubin biss għal amministrazzjoni minn professjonisti tal- kura tas- saħħa, bħal fil- kaħ ta ’ Elaprase.
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Elaprase 2 mg/ ml sterile concentrate Idursulfase Intravenous use
Elaprase 2 mg/ ml sterili konċentrat Idursulfase Użu għal ġol- vini
Read the enclosed package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
Read all of this leaflet carefully before you start having this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Elaprase is and what it is used for 2.
X’ inhu Elaprase u għalxiex jintuża 2.
What you need to know before you have Elaprase 3.
Qabel ma tieħu Elaprase 3.
How Elaprase is given to you 4.
Kif tingħata Elaprase 4.
Possible side effects 5 How Elaprase is stored 6.
Kif taħżen Elaprase 6.
WHAT ELAPRASE IS AND WHAT IT IS USED FOR
X’ INHU ELAPRASE U GĦALXIEX JINTUŻA
Elaprase is used as enzyme replacement therapy to treat Hunter syndrome (Mucopolysaccharidosis II) when the level of iduronate-2-sulfatase in the body is lower than normal.
Elaprase jintuża bħala terapija ta ’ sostituzzjoni ta ’ l- enzimi biex jitratta s- sindromu ta ’ Hunter (Mucopolysaccharidosis II) meta l- livell ta ’ iduronate- 2- sulfatase fil- ġisem ikun iktar baxx mis- soltu.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE ELAPRASE
QABEL MA TIEĦU ELAPRASE
Is there any reason for not being given Elaprase?
Hemm xi raġuni li għaliha m’ għandekx tingħata Elaprase?
If you are allergic (hypersensitive) to idursulfase or any of the other ingredients of Elaprase.
Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal idursulfase jew għal xi sustanza oħra ta ’ Elaprase.
If you are treated with Elaprase you may experience reactions during or following an infusion (see section 4 Possible Side Effects).
Oqgħod attent ħafna b’ Elaprase Jekk tkun qed tingħata trattament b’ Elaprase jista ’ jkollok xi reazzjonijiet waqt jew wara infużjoni (ara s- sezzjoni 4 Effetti sekondarji li jista ’ jkollok).
The most common symptoms are itching, rash, hives, fever, headache, increased blood pressure, and flushing (redness).
L- iktar sintomi komuni huma l- ħakk, raxx, ħorriqija, deni, uġigħ ta ’ ras, żieda fil- pressjoni, u ħmura.
Most of the time you can still be given Elaprase even if these symptoms occur.
Ħafna drabi xorta tkun tista ’ tingħata Elaprase anke jekk ikollok dawn is- sintomi.
If you experience an allergic side effect following administration of Elaprase, you should contact your doctor immediately.
Jekk ikollok reazzjoni allerġika wara l- għoti ta ’ Elaprase, għandek tikkuntattja lit- tabib tiegħek immedjatament.
You may be given additional medicines such as antihistamines and corticosteroids to treat or help prevent allergic-type reactions.
Tista ’ tingħata mediċini oħra bħal kortikosterojdi u anti - istaminiċi biex jittrattaw jew jgħinuk tevita reazzjonijiet allerġiċi.
If severe allergic (anaphylactic-type) reactions occur, your doctor will stop the infusion immediately, and start giving you suitable treatment.
Jekk ikun hemm reazzjonijiet allerġiċi severi (anafilattiċi), it- tabib iwaqqaf l- infużjoni immedjatament, u jibda jagħtik trattament xieraq.
You may need to stay in hospital.
Jista ’ jkollok bżonn tibqa ’ l- isptar.
There is no known interaction of Elaprase with other medicines.
Meta tieħu mediċini oħra Mhux magħruf li Elaprase jinteraġixxi ma ’ mediċini oħra.
Taking Elaprase with food and drink
Meta tieħu Elaprase ma ’ l- ikel u max- xorb Minħabba l- mod li bih jiġi metabolizzat mill- prodott fil- ġisem, huwa improbabbli li l- prodott jinteraġixxi ma ’ l- ikel jew max- xorb.
Due to the way the product is broken down by the body interactions with food and drink are unlikely.
Tqala u Treddigħ Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
19 Pregnancy and breast-feeding
19 Sewqan u tħaddim ta ’ magni Mhux magħruf jekk Elaprase jaffettwax il- ħila biex issuq jew tħaddem magni.
HOW ELAPRASE IS GIVEN TO YOU
KIF TINGĦATA ELAPRASE
Elaprase has to be diluted in 9 mg/ ml (0.9%) sodium chloride solution for infusion before use.
Elaprase irid jitħallat ma ’ l- ilma bil- melħ għall- infużjoni b’ konċentrazzjoni ta ’ 9 mg/ ml (0. 9%) qabel jintuża.
The usual dose is an infusion of 0.5 mg (half a milligramme) for every kg you weigh.
Id- doża wżata normalment hi ta ’ 0. 5 mg (nofs milligramma) għal kull kilogramm li tiżen.
After dilution Elaprase is given through a vein (drip feed).
Wara li jitħallat, Elaprase jingħata minn vina (bid- drip).
The infusion will normally last for 1 to 3 hours and will be given every week.
L- infużjoni normalment iddum bejn siegħa u 3 sigħat u tingħata kull ġimgħa.
What will happen if I am given too much Elaprase?
X’ jiġri jekk ningħata doża eċċessiva ta ’ Elaprase?
There is no experience with overdoses of Elaprase.
M’ hemmx esperjenza dwar dożi eċċessivi ta ’ Elaprase.
If you have missed an Elaprase infusion, please contact your doctor.
Jekk tinsa tieħu Elaprase Jekk taqbeż doża ta ’ l- infużjoni ta ’ Elaprase, jekk jogħġbok ikkuntattja lit- tabib tiegħek.
Like all medicines, Elaprase can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Elaprase jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate and associated with the infusion, however some side effects may be serious.
Il- biċċa l- kbira ta ’ l- effetti sekondarji huma ħfief jew moderati u assoċjati ma ’ l- infużjoni, iżda xi effetti sekondarji jistgħu jkunu serji.
Over time the number of these infusion-associated reactions decreases.
Maż- żmien, l- għadd ta ’ reazzjonijiet assoċjati ma ’ l- infużjoni jonqsu.
Very common side effects (more than 1 per 10) are: • Headache • Increased blood pressure • Chest pain • Hives, rash, itching • Fever, and infusion site swelling
Uġigħ ta ’ ras • Żieda fil- pressjoni • Uġigħ fis- sider • Ħorriqija, raxx, ħakk • Deni, u nefħa fis- sit ta ’ l- infużjoni •
Common side effects (more than 1 per 100) are: • Dizziness, tremor • Teary eyes • Changes in the way your heart beats, bluish skin • Decreased blood pressure, flushing (redness) • Difficulty breathing, wheezing, blood clot in the lung artery, cough, quickened breathing • Abdominal pain, nausea, diarrhoea, swollen tongue • Facial swelling, skin lesions (redness, eczema) • Pain in the joints • Swelling of the extremities
Sturdament, rogħda • Għajnejn idemmgħu • Tibdil fil- mod ta ’ taħbit tal- qalb, ġilda kaħlanija • Pressjoni baxxa, ħmura • Tbatija biex tieħu n- nifs, tħarħir, għoqda tad- demm f’ arterja tal- pulmun, sogħla, nifs mgħaġġel • Uġigħ ta ’ żaqq, dardir, dijarea, nefħa fl- ilsien • Nefħa fil- wiċċ, leżjonijiet fil- ġilda (ħmura, ekżema) • Uġigħ fil- ġogi • Nefħa fl- estremitajiet ta ’ l- idejn u tas- saqajn •
If you have problems breathing, with or without bluish skin, tell your doctor immediately.
Jekk tibda tbati biex tieħu n- nifs, u l- ġilda ssir kaħlanija jew tibqa ’ b’ lewn normali, għarraf lit - tabib tiegħek immedjatament.
If any of the side effects gets serious, or if your notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW ELAPRASE IS STORED
KIF TAĦŻEN ELAPRASE
Keep out of reach and sight of children.
Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use Elaprase after the expiry date which is stated on the label after the letters EXP.
Tużax Elaprase wara d- data ta ’ skadenza li tidher fuq it- tikketta wara l- ittri JIS.
Store in a refrigerator (2°C – 8°C) Do not freeze
Aħżen il- prodott fi friġġ (2°C – 8°C) 20 Tagħmlux fil- friża
Do not use Elaprase if you notice that there is discolouration or presence of foreign particles.
Tużax Elaprase jekk tinnota tibdil fil- kulur jew il- preżenza ta ’ partiċelli barranin.
What Elaprase contains
X’ fih Elaprase?
The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase.
Is- sustanza attiva hi idursulfase, li hi forma ta ’ l- enzim uman iduronate- 2- sulfatase.
Idursulfase is produced in a human cell line by genetic engineering technology.
Idursulfase jiġi prodott f’ linja ta ’ ċelloli umani permezz tat- teknoġija ta ’ l- inġinerija ġenetika.
Each vial of Elaprase contains 6 mg of idursulfase.
Kull kunjett ta ’ Elaprase jkun fiha 6 mg idursulfase.
Each ml contains 2 mg of idursulfase.
Kull millilitru jkun fih 2 mg idursulfase.
The other ingredients are Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Water for injections
Is- sustanzi l- oħra huma Polysorbate 20 Sodium chloride Sodium phosphate dibasic, heptahydrate Sodium phosphate monobasic, monohydrate Ilma għall- injezzjonijiet
What Elaprase looks like and contents of the pack
Id- Dehra ta ’ Elaprase u l- kontenut tal- pakkett
Elaprase is a concentrate for solution for infusion.
Elaprase hu konċentrat biex jitħallat għall- infużjoni.
It is supplied in a glass vial as a clear to slightly opalescent, colourless solution.
Jiġi fi kunjett tal- ħġieġ bħala soluzzjoni bla kulur bejn ċara u bejn kemmxejn opalexxenti.
Each vial contains 3 ml of concentrate for solution for infusion.
Kull kunjett jkun fiha 3 ml ta ’ konċentrat għat- taħlit għall- infużjoni.
Elaprase is supplied in pack sizes of 1, 4 and 10 vials per carton Not all pack sizes may be marketed.
Elaprase jiġi pprovvdut f’ pakketti bi kunjett waħda, b’ erba ’ kunjetti u b’ 10 kunjetti kull kartuna.
Marketing Authorisation Holder Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Sweden
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, L- Isvezja.
Shire Human Genetic Therapies AB, Åldermansgatan 2, PO Box 1117, SE 221 04 Lund, Sweden
Shire Human Genetic Therapies AB, Åldermansgatan 2, Box 1117, 221 04 Lund, L- Iżvezja
This medicine has been authorised under “ exceptional circumstances”.
Din il- mediċina kienet awtorizzata taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Dan ifisser li minħabba li l- marda li qed tbati minnha hija rari kien impossibbli li tinkiseb informazzjoni kompleta dwar din il- mediċina.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) ser tirrevedi kull tip ta ’ informazzjoni ġdida li toħroġ kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
More detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni iktar dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
There are also links to other web sites about rare disease and treatments. ---------------------------------------------------------------------------------------------------------------------------------
Hemm ukoll links għall- websites oħra dwar mard rari u kura. -----------------------------------------------------------------------------------------------------------------------
21 Instructions for use, handling and disposal
Struzzjonijiet għall- użu, maniġġ u rimi
Calculate the total dose to be administered and number of Elaprase vials needed.
Ikkalkula d- doża totali li trid tingħata u l- għadd ta ’ kunjetti ta ’ Elaprase meħtieġa.
Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of 9 mg/ ml sodium chloride solution for infusion (0.9%w/ v).
Iddilwa l- volum totali meħtieġ ta ’ Elaprase f’ 100 ml ta ’ 9 mg/ ml (0. 9%) soluzzjoni ta ’ sodium chloride għal infużjoni.
The solution should be inspected visually for particulate matter and discolouration prior to administration.
Ifli s- soluzzjoni biex tara jekk hemmx xi trab mhux maħlul jew tibdil fil- kulur qabel l- għoti.
It is recommended that administration is started as soon as possible.
Huwa rrikmandat li l- għoti jinbeda malajr kemm jista ’ jkun.
The chemical and physical stability of the diluted solution has been demonstrated for 8 hours at 25°C.
Intwera li s- soluzzjoni dilwita tibqa ’ fiżikament u kimikament stabbli għal 8 sigħat f’ temperatura ta ’ 25°C.
Do not infuse Elaprase concomitantly in the same intravenous line with other agents.
Tagħtix Elaprase fl- istess linja għall- għoti ta ’ mediċini fil- vina li fiha fl- istess ħin ikunu qed jingħataw aġenti oħra.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal - prodott għandu jintrema kif jitolbu l- liġijiet lokali.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT PUBBLIKU EWROPEW TA 'VALUTAZZJONI (EPAR)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta 'Valutazzjoni (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqa, sabiex jasal għar- rakkomandazzjonijiet tiegħ dwar kif tintuża l- mediċina.
What is Emadine?
X’ inhu EMADINE?
Emadine is a clear eye drop solution.
Emadine hu soluzzjoni ċara tat- taqtir tal- għajnejn.
It contains the active substance emedastine (0.5 mg/ ml).
Fih is- sustanza attiva emedastine (0. 5 mg/ ml).
Emadine is available in a bottle and in single-dose containers.
Emadine jiġi fi flixkun u f’ reċipjenti ta ’ doża waħdanija.
What is Emadine used for?
Għal xiex jintuża Emadine?
Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Emadine jintuża fit- trattament ta ’ sintomi tal- konġuntivite allerġika staġjonali (infjammazzjoni tal - għajnejn ikkawżata mill- polline f’ pazjenti bil- hayfever).
These symptoms include itching, redness and swelling.
Dawn is- sintomi jinkludu ħakk, ħmura u nefħa.
Emadine is used in adults and children aged three years and older.
Emadine jintuża f’ adulti u tfal minn tliet snin ‘ il fuq.
How is Emadine used?
Kif jintuża Emadine?
Emadine is given as one drop in the affected eye(s) twice a day.
Emadine jingħata bħala qatra waħda fil- għajn( ejn) imwettqa darbtejn kuljum.
Its effects have not been studied beyond six weeks.
L- effetti tiegħu ma ġewx studjati għal iktar minn sitt ġimgħat.
If more than one type of eye drop is being used, each one should be given at least 10 minutes apart.
Jekk qed jintużaw aktar minn tip wieħed ta ’ qtar tal- għajnejn, kull wieħed għandu jingħata tal- inqas 10 minuti bogħod minn xulxin.
Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Emadine mhux rakkomandat għal pazjenti ta ’ iktar minn 65 sena jew f’ pazjenti li jkollhom problemi fil- fwied jew fil- kliewi.
How does Emadine work?
Kif jaħdem Emadine?
The active substance in Emadine, emedastine, is an antihistamine.
Is- sustanza attiva f’ Emadine, emedastine, hija prodott anti- istaminiku.
It works by blocking the receptors that histamine normally attaches to.
Taħdem billi timblokka r - riċetturi li magħhom normalment teħel l- istamina.
Histamine is a substance in the body that causes allergic symptoms.
Histamine hija sustanza fil- ġisem li tikkawża sintomi allerġiċi.
When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Meta r- riċetturi jiġu imblukkati, l- istamina ma tkunx tista ’ tagħmel effett, li jwassal għal tnaqqis fis- sintomi tal- allerġija.
How has Emadine been studied?
Kif ġie studjat Emadine?
Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Emadine ġie mqabbel ma ’ levocabastine (histamine ieħor) fi studji ewlieni li fih ħadu sehem 222 pazjent ta ’ erba ’ snin jew iktar bil- konġuntivite staġjonali.
The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Il- mezz ewlieni tal- kejl tal- effettività kien it- tnaqqis fil- ħakk u l- ħmura, imkejjel fuq skala ta ’ disa ’ punti fuq perjodu ta ’ mhux iktar minn sitt ġimgħat.
The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘ allergen challenge’.
Il- kumpanija ppreżentat ukoll ir- riżultati ta ’ studji li fihom il- pazjenti ngħataw Emadine, levocabastine jew plaċebo (trattament finta) qabel ma ġew soġġetti għal ‘ sfida allerġenika ’.
This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
Dan hu test li fih il - pazjenti b’ allerġija li dak il- ħin ma jkunux qed juru sinjali allerġiċi, jingħataw doża definita ta ’ allerġen (is- sustanza li għaliha jkunu allerġiċi) biex tiġi stimulata reazzjoni allerġika.
What benefit has Emadine shown during the studies?
X’ inhuma l- benefiċċji ta ’ EMADINE li ntwerew f’ dawn l- istudji?
Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Emadine kien effettiv daqs levocabastine fit- tnaqqis tas- sintomi ta ’ konġuntivite staġjonali.
Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Fiż- żewġ gruppi ta ’ pazjenti, il- punteġġi li jirriflettu l- ħakk naqsu minn madwar 5. 1 fil- bidu tal- istudju, għal madwar 3. 8 wara ħames minuti u għal madwar 2. 7 wara sagħtejn.
In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks.
Deher tnaqqis simili fil- punteġġi tal- ħmura, li naqsu minn madwar 3. 9 fl- ewwel jum, niżlu għal madwar 0. 8 għal Emadine u 2. 0 għal levocabastine wara sitt ġimgħat.
For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Għall- ħmura, il- punteġġi naqsu minn madwar 2. 7 għal 0. 5 for Emadine u għal 1. 1 għal levocabastine.
Similar results were seen in adults and in children.
Dehru riżultati simili fl- adulti u fit- tfal.
The results of the allergen challenge tests supported these results.
Ir- riżultati tat- testijiet tal- isfidi allerġeniċi saħħew dawn ir- riżultati.
What is the risk associated with Emadine?
X’ inhu r- riskju assoċjat ma ’ Emadine?
The most common side effects with Emadine (seen in between 1 and 10 patients in 100) are headache, eye pain, eye irritation, blurred vision, eye pruritus (itchy eye), dry eye, staining of the cornea (the transparent layer in front of the pupil) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).
L- iktar effetti sekondarji komuni b’ Emadine (li dehru f’ bejn pazjent wieħed u 10 minn kull 100) huma uġiegħ ta ’ ras, uġiegħ tal- għajnejn, irritazzjoni tal- għajnejn, vista mċajpra, prurite (irritazzjoni fl - għajnejn), inxif fl- għajnejn, tħammiġ tal- kornea (il- parti trasparenti quddiem il- ħabba tal- għajn) u konġunġivite iperemja (żjieda fil- fluss tad- demm fil- għajn, li jwassal għal ħmura).
For the full list of all side effects reported with Emadine, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji rappurtati b’ Emadine, ara l- Fuljett ta ’ Tagħrif.
Emadine should not be used in people who may be hypersensitive (allergic) to emedastine or any of the other ingredients.
Emadine m’ għandux jingħata lil persuni allerġiċi għal emedastine jew għal xi sustanza oħra tiegħu.
The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Il - forma ta ’ Emadine fil- flixkun ikun fiha benzalkonium chloride, li hu magħruf li jibdel il- kulur ta ’ lentijiet tal- kuntatt rotob.
Therefore, care should be taken by people who wear soft contact lenses.
Għalhekk min jilbes lentijiet tal- kuntatt rotob għandu joqgħod attent.
Why has Emadine been approved?
Għaliex ġie approvat Emadine?
The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine’ s benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Emadine fit- trattament tal- konġuntivite allerġika staġjonali huma ikbar mir- riskji.
The Committee recommended that Emadine be given marketing authorisation.
Il- Kumitat irrakkomanda li Emadine jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Emadine:
Tagħrif ieħor dwar Emadine:
The European Commission granted a marketing authorisation valid throughout the European Union for Emadine to Alcon Laboratories (UK) Ltd. on 27 January 1999.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Emadine valida fl- Unjoni Ewropea kollha lil Alcon Laboratories (UK) Ltd. fis- 27 ta ’ Jannar 1999.
The marketing authorisation was renewed on 27 January 2004 and on 27 January 2009.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 27 ta ’ Jannar 2004.
The full EPAR for Emadine can be found here.
L- EPAR sħiħ għal Emadine huwa disponibbli minn hawnhekk.
This summary was last updated in 01-2009.
Dan is- sommarju ġie aġġornat l- aħħar f’ 01- 2009.
EMADINE 0.5 mg/ ml, Eye Drops, solution in multidose container
EMADINE 0. 5 mg/ ml, Qtar Għall- Għajnejn, soluzzjoni f’ kontenitur b’ ħafna dożi.
1 ml of solution contains emedastine 0.5 mg (as difumarate)
1 ml ta ’ soluzzjoni fih 0. 5 mg emedastine (bħala difumarate)
Benzalkonium chloride 0.1 mg/ ml
Benzalkonium chloride 0. 1 mg/ ml
Eye drops, (solution).
Qtar għall- għajnejn, (soluzzjoni).
Symptomatic treatment of seasonal allergic conjunctivitis.
Kura sintomatika ta ’ konġuntivite allerġika ta ’ l- istaġun.
Posology The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily.
EMADINE ma ’ ġiex studjat fi provi kliniċi għal iżjed minn sitt ġimgħat. Pożoloġija Id- doża hija qatra waħda ta ’ EMADINE li għandha tiġi applikata fl- għajn( ejn) darbtejn kuljum.
When used with other ophthalmic medicines, an interval of ten minutes should be allowed between applications of each medicinal product.
Meta jintuża flimkien ma ’ mediċini għall- għajnejn oħra, għandu jitħalla interval ta ’ għaxar minuti bejn l- applikazzjoni ta ’ kull prodott mediċinali.
Elderly population EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not recommended in this population.
Popolazzjoni anzjana EMADINE ma ’ ġiex studjat f’ pazjenti anzjani b’ età ’ l fuq minn 65 sena, għalhekk l- użu tiegħu f’ din il- popolazzjoni mhux irrakkomandat.