qanastek/EMEA-V3 huggingface dataset:
The MAH commits to analysing the data from patients who have received clinical and then commercial process product to determine if there was any change to safety (antibody formation) or efficacy parameters stemming from the transition to commercial material and will provide this analysis in the clinical study reports for each of these studies when complete.
Id- Detentur ta ’ l- Awtorizzazzjoni għat - tqegħid fis- Suq jikkommetti ruħu li janalizza t- tagħrif minn pazjenti li rċevew il- prodott kliniku u wara dak kummerċjali biex ikun determinat jekk kienx hemm xi bdil fil- parametri ta ’ sigurtà (formazzjoni ta ’ antikorpi) jew ta ’ effikaċja li jkun ġej mill- bdil għal materjal kummerċjali u li jipprovdi din l - analiżi fir- rapporti ta ’ studji kliniċi għal kull wieħed minn dawn l- istudji meta jkunu finalizzati.
(CARTON)
(KARTUNA)
Naglazyme 1 mg/ ml concentrate for solution for infusion Galsulfase
Naglazyme 1 mg/ ml Konċentrat għal soluzzjoni għall- infużjoni Galsulfase
Sodium chloride Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80 Water for injections
Sodium chloride Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80 Ilma għall- injezzjoni
1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/ 5 ml
kunjett ta ’ konċentrat għal soluzzjoni għall- infużjoni 6 kunjett ta ’ konċentrat għal soluzzjoni għall- infużjoni 5 mg/ 5 ml
Intravenous use Read the package leaflet before use.
Użu għal ġol- vina Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP MM/ YYYY
JIS MM/ YYYY
Store in a refrigerator Do not freeze
Aħżen fi friġġ Tagħmlux fil- friża.
For single use only Any unused solution should be discarded
Għall- użu ta ’ darba biss Soluzzjoni li ma tintużax għandha tintrema
BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL United Kingdom
BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL Ir- Renju Unit
EU/ 1/ 05/ 324/ 001 1 vial EU/ 1/ 05/ 324/ 002 6 vials
EU/ 1/ 05/ 324/ 001 kunjett 1 EU/ 1/ 05/ 324/ 002 6 kunjetti
{Clear type 1, 5 ml VIAL}
{KUNJETT 5 ml, Ċar tat- tip 1}
Naglazyme, 1 mg/ ml Concentrate for solution for infusion Intravenous use
Naglazyme, 1 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Użu għal ġol- vina
Naglazyme 1 mg/ ml concentrate for solution for infusion Galsulfase
Naglazyme 1 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Galsulfase
What Naglazyme is and what it is used for 2.
X’ inhu Naglazyme u għalxiex jintuża 2.
Before you take Naglazyme 3.
Qabel ma tieħu Naglazyme 3.
How to take Naglazyme 4.
Kif għandek tieħu Naglazyme 4.
How to store Naglazyme 6.
Kif taħżen Naglazyme 6.
WHAT NAGLAZYME IS AND WHAT IT IS USED FOR
X’ INHU NAGLAZYME U GĦALXIEX JINTUŻA
Galsulfase is a form of the human enzyme N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology.
Galsulfase huwa forma ta ’ l- enżima umana N- acetylgalactosamine 4- sulfatase u huwa magħmul b’ teknoloġija ta ’ DNA rikombinanti.
It is used for enzyme replacement therapy in Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome), a storage disorder where the level of N- acetylgalactosamine 4-sulfatase enzyme activity is absent or lower than normal.
Huwa jintuża għat- terapija ta ’ sostituzzjoni ta ’ enżimi f’ Mucopolisakkaridosi VI (MPS VI; sindromu ta ’ Maroteaux- Lamy), disturbi fil- ħażna fejn il- livell ta ’ attività tal- enżima N- acetylgalactosamine 4- sulfatase hija assenti jew anqas minn normal.
If you suffer from the MPS VI storage disorder, the reduced or absent N-acetylgalactosamine 4-sulfatase activity results in the accumulation of substrates in most cell types and tissue.
Jekk issofri minn disturbi fil- ħażna MPS VI, l- attività mnaqqsa jew assenti ta ’ N- acetylgalactosamine 4- sulfatase tirriżulta f’ akkumulazzjoni ta ’ substratti fil- biċċa l- kbira ta ’ tipi ta ’ ċelluli u tessuti.
Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency).
Naglazyme huwa ndikat għall- terapija fit- tul ta ’ sostituzzjoni ta ’ enżima f’ pazjenti b’ dijanjosi kkonfermata ta ’ Mucopolisakkaridosi VI (MPS VI; defiċjenza ta ’ N- acetylgalactosamine 4- sulfatase).
BEFORE YOU USE NAGLAZYME
QABEL MA TUŻA NAGLAZYME
Do not use Naglazyme
Tużax Naglazyme
- If you are allergic (hypersensitive) to galsulfase or any of the other ingredients of Naglazyme.
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal galsulfase jew sustanzi oħra ta ’
- If you develop an infusion-associated reaction while being treated with Naglazyme, you should
- Jekk tiżviluppa reazzjoni assoċjata ma ’ l- infużjoni waqt li qed tiġi kkurat b’ Naglazyme, kellem
contact your physician immediately (see section 4)
lit- tabib tiegħek immedjatament (ara sezzjoni 4).
- If you have a fever, or if you are having difficulty breathing, talk with your doctor about
- Jekk għandek id- deni jew qed ikollok diffikultà biex tieħu n- nifs, kellem lit- tabib tiegħek dwar
delaying your Naglazyme infusion.
il- possibiltà li tittardja l- infużjoni tiegħek ta ’ Naglazyme.
If severe allergic or
- Bħal b’ kull prodott mill- proteina għal użu għal ġol- vini, reazzjonijiet allerġiċi huma possibli.
anaphylactic reactions occur, immediate discontinuation of the administration of Naglazyme may be considered and an appropriate treatment will have to be initiated by your physician.
Jekk iseħħu reazzjonijiet allerġiċi jew anafilattiċi severi, jista ’ jiġi kkunsidrat li jitwaqqaf l- għoti ta ’ Naglazyme immedjatament u kura xierqa għandha tinbeda mit- tabib tiegħek.
The safety and efficacy of Naglazyme in children below the age of 5 years and in patients older than 65 years have not been established.
Is- sigurtà u l- effikaċja fi tfal taħt l- età ta ’ 5 snin u f’ pazjenti ta ’ età akbar minn 65 sena, ma ġietx stabbilita.
20 Kidney and liver insufficiency:
Insuffiċjenza tal- kliewi u tal- fwied:
The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated.
Is- sigurtà u l- effikaċja ta ’ Naglazyme f’ pazjenti b’ insuffiċjenza renali jew epatika ma ġewx evalwati.
Using other medicines There are no known interactions with other medicinal products.
20 Meta tuża mediċini oħra Ma hemmx interazzjonijiet magħrufa ma ’ prodotti mediċinali oħra.
Using Naglazyme with food and drink Naglazyme is given via intravenous infusion, therefore no interaction with food and drink is expected.
Meta tuża Naglazyme ma ’ l- ikel u max- xorb Naglazyme jingħata permezz ta ’ infużjoni ġol- vina, għalhekk mhux mistennija interazzjonijiet ma ’ l - ikel u max- xorb.
Pregnancy Naglazyme should not be used during pregnancy unless clearly necessary.
Tqala Naglazyme m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku.
Breast-feeding It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Treddigħ Mhux magħruf jekk galsulfase joħroġx fil- ħalib, għalhekk it- treddigħ għandu jitwaqqaf waqt kura b’ Naglazyme.
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 biex ssuq jew tħaddem magni.
HOW TO USE NAGLAZYME
KIF GĦANDEK TUŻA NAGLAZYME
The concentrate for solution for infusion has to be diluted prior to administration by intravenous infusion.
Il- konċentrat għal soluzzjoni għall- infużjoni għandu jiġi dilwit qabel jingħata permezz ta ’ infużjoni fil - vini.
Dosage The recommended dosage regimen of galsulfase is 1 mg/ kg body weight administered once every week as an intravenous infusion.
Dożaġġ Il- kors ta ’ dożaġġ rakkomandat ta ’ galsulfase huwa ta ’ 1 mg/ kg piż tal- ġisem mogħti darba fil- ġimgħa bħala infużjoni fil- vini.
The initial infusion rate is adjusted so that approximately 2.5% of the total solution is infused during the first hour, with infusion of the remaining volume (approximately 97.5%) over the next 3 hours.
Ir- rata tal- bidu ta ’ l- infużjoni tiġi aġġustata biex madwar 2. 5% tas- soluzzjoni totali tkun infuża fl- ewwel siegħa, u l- bqija tal- volum (madwar 97. 5%) jiġi infuż fuq it- 3 sigħat ta ’ wara.
If you use more Naglazyme than you should No case of overdose of Naglazyme has been reported.
Jekk tuża Naglazyme aktar milli suppost L- ebda każ ta ’ doża eċċessiva ta ’ Naglazyme ma ġie rrappurtat.
If you forget to take Naglazyme If you forget to take Naglazyme, please contact your doctor.
Jekk tinsa tuża Naglazyme Jekk tinsa tieħu Naglazyme, jekk jogħġbok kellem lit- tabib tiegħek.
If a dose is partially administered or missed, the next dose will not be increased to make up for this.
Jekk doża ma ġietx mogħtija kollha jew kienet maqbuża, d- doża ta ’ wara m’ għandiex tiżdied biex tpatti għal dan.
Like all medicines, Naglazyme can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Naglazyme jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects were reported as being related to Naglazyme:
L- effetti sekondarji li ġejjin kienu rrappurtati bħala relatati ma ’ Naglazyme.
Very common (greater than 1 out of 10 patients):
Komuni ħafna (aktar minn 1 minn kull 10 pazjenti):
Abdominal pain, ear pain, pain, reddened eye, shortness of breath, chills, chest pain, sore throat, stomach pain, poor reflexes, cloudy eyes, swollen face, gastroenteritis, high blood pressure, malaise, nasal congestion, bulging belly button, fever, headache, rash, nausea, vomiting and joint pain.
Uġigħ addominali, uġigħ fil- widnejn, uġigħ, għajnejn ħomor, qtugħ ta ’ nifs, rogħda ta ’ bard, uġigħ fis- sider, uġigh fil- grizmejn, uġigħ fl- istonku, riflessi batuti, għajnejn imċajpra, nefħa fil- wiċċ, gastro- enterite, pressjoni tad- demm għolja, telqa, imnieħer misdud, żokra mqabbża, deni, uġigħ ta ’ ras, raxx, tqalligħ, rimettar u uġigħ fil- ġogi.
21 Common (greater than 1 out of 100 patients):
Komuni (aktar minn 1 minn kull 100 pazjent):
Hives, swelling of the tongue and throat, low blood pressure, difficulty breathing and apnoea.
Ħorriqija, nefħa ta ’ l- ilsien u tal- griżmejn, pressjoni tad- demm baxxa, diffikultà biex tieħu n- nifs u apneja.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
21 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 TO STORE NAGLAZYME
KIF TAĦŻEN NAGLAZYME
Do not use Naglazyme after the expiry date which is stated on the vial after EXP.
Tużax Naglazyme wara d- data ta ’ skadenza li tidher fuq il- kunjett wara JIS.
Do not use after the expiry date stated on the labelling after the letters EXP.
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta wara JIS.
Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23°C - 27°C).
Stabbilità kimika u fiżika waqt l- użu kienet demostrata sa 4 tijiem f’ temperatura tal- kamra (23°C - 27°C).
From a microbiological safety point of view, the product is to be used immediately.
Mill- aspett ta ’ sigurta ’ mikrobijoloġika, il- prodott għandu jintuża ’ immedjatament.
If not used immediately, in-use storage times and conditions are the responsibility of the user and must normally not be longer than 24 hours at 2°C - 8°C followed by up to 24 hours at room temperature (23°C - 27°C) during administration.
Jekk ma jintużax immedjatament, il- ħin u l- kondizzjonijiet ta ’ ħażna waqt l- użu huma r- responsabbilità ta ’ minn qed juża ’ l- prodott, u normalment m’ għandhomx ikunu itwal minn 24 siegħa f’ temperatura ta ’ 2°C - 8°C, segwit minn massimu ta ’ 24 siegħa f’ temperatura tal- kamra (23°C - 27°C) waqt li jkun qed jingħata.
Do not use Naglazyme if it contains visible particles.
Tużax Naglazyme jekk ikun fih xi frak li jidher.
What Naglazyme contains
X’ fih Naglazyme:
- The active substance is galsulfase.
- Is- sustanza attiva hija galsulfase.
One ml of Naglazyme contains 1 mg galsulfase.
Ml wieħed ta ’ Naglazyme fih 1 mg ta ’ galsulfase.
One vial of
Kunjett
5 ml contains 5 mg galsulfase.
wieħed ta ’ 5 ml fih 5 mg galsulfase.
Galsulfase is recombinant human N-acetylgalactosamine 4- sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Galsulfase huwa forma rikombinanti ta ’ N - acetylgalactosamine 4- sulfatase uman magħmul permezz ta ’ inġinerija ġenetika minn ċelluli tal - Ovarju tal- Hamster Ċiniż (CHO).
- The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate,
- Is- sustanzi l- oħra huma: sodium chloride, sodium phosphate monobasic, monohydrate, sodium
sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
phosphate dibasic, heptahydrate, polysorbate 80, ilma għall- injezzjoni.
What Naglazyme looks like and contents of the pack Naglazyme is supplied as a concentrate for solution for infusion.
Naglazyme huwa pprovdut bħala konċentrat għal soluzzjoni għall- infużjoni.
The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Il- konċentrat ċar għal kemmxejn ikanġi, u bla kulur għal isfar ċar ma ’ jridx ikun fih frak viżibbli.
The solution must be diluted further before it can be infused.
Is- soluzzjoni għandha tiġi dilwita qabel ma tkun tista ’ tiġi nfuża.
1 and 6 vials.
1 u 6 kunjett.
Not all package sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall - skop kummerċjali.
22 Marketing authorization Holder BioMarin Europe Limited, 164 Shaftesbury Avenue London, WC2H 8HL United Kingdom
BioMarin Europe Limited, 164 Shaftesbury Avenue
Manufacturer Catalent UK Packaging Ltd., Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX United Kingdom
Catalent UK Packaging Ltd., Wingates Industrial Park, Westhoughton, Bolton, Lancs, BL5 3XX Ir- Renju Unit
For any information about this medicine 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:
This medicine has been authorised under “ exceptional circumstances”.
Din il- mediċina kienet awtorizzata taħt ‘ ċirkustanzi ta ’ eċċezzjoni ’.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għall- websites oħra dwar mard rari u l - kura.
24 < -------------------------------------------------------------------------------------------------------------------------- --- The following information is intended for medical or healthcare professionals only:
---------------------------------------------------------------------------------------------------------------------
Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Naglazyme m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn fl- istess infużjoni, ħlief dawk imsemmija hawn taħt.
The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ ml (0.9%) solution for infusion using aseptic technique.
Il- konċentrat għal soluzzjoni għall - infużjoni jrid jiġi dilwit b’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) permezz ta ’
Preparation of the Naglazyme Infusion (Use Aseptic Technique)
Preparazzjoni ta ’ l- Infużjoni ta ’ Naglazyme (Għandha Tintuża Teknika Asettika)
The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.
Is- soluzzjoni ċara għal kemmxejn tkanġi, u bla kulur għal safra ċara m’ għandux ikollha frak viżibbli.
100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/ min) should be decreased so that the total duration remains no less than 4 hours.
Boroż ta ’ l- infużjoni ta ’ 100 ml għandhom jiġu kkunsidrati għall- pazjenti li huma suxxettibli għal ammont eċċessiv ta ’ volum ta ’ fluwidi u jiżnu anqas minn 20 kg; f’ dan il- każ ir- rata ta ’ l- infużjoni (ml/ min) għandha titnaqqas biex b’ hekk l- infużjoni tingħata fuq medda ta ’ ħin totali ta ’ mill- anqas 4 sigħat.
The solution is to be mixed gently for infusion.
Is- soluzzjoni trid titħallat bil- mod qabel l- infużjoni.
Clear and colourless solutions without visible particles should be used.
Għandhom jintużaw biss soluzzjonijiet ċari, bla kulur u mingħajr frak viżibbli.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll ara parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Neoclarityn?
X' inhu Neoclarityn?
Neoclarityn is a medicine containing the active substance desloratadine.
Neoclarityn 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, 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 Neoclarityn used for?
Għal xiex jintuża Neoclarityn?
Neoclarityn 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).
Neoclarityn 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 Neoclarityn used?
Kif jintuża Neoclarityn?
The dose in children depends on their age.
Id- doża għat- tfal tiddependi mill- età tagħhom.
For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution.
Għal tfal li l- età tagħhom tvarja minn sena sa ħames snin, id- doża hi ta '1. 25 mg darba kuljum, li tittieħed bħala 2. 5 ml mistura jew soluzzjoni orali.
For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Għal tfal li l- età tagħhom tvarja bejn sitta u ħdax- il sena, id- doża hi ta '2. 5 mg darba kuljum, li tittieħed jew bħala 5 ml mistura jew soluzzjoni orali, jew bħala pillola ta' 2. 5 mg li tinħall fil- ħalq.
Adults and adolescents can use any form of the medicine.
L- adulti u l - adoloxxenti jistgħu jużaw kwalunkwe għamla tal- mediċina.
Neoclarityn can be taken with or without food.
Neoclarityn jista 'jittieħed fuq stonku vojt jew le.
How does Neoclarityn work?
Kif jaħdem Neoclarityn?
The active substance in Neoclarityn, desloratadine, is an antihistamine.
Is- sustanza attiva f' Neoclarityn, 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.
How has Neoclarityn been studied?
Kif ġie studjat Neoclarityn?
Neoclarityn 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 Neoclarityn 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 Neoclarityn 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 'Neoclarityn 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.
Neoclarityn has also been studied in 416 patients with urticaria.
Neoclarityn ġie studjat ukoll f' 416- il pazjent b' urtikarja.
In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Fl- istudji kollha, l- effikaċja ta 'Neoclarityn tqabblet ma' dik ta 'plaċebo (trattament finta).
What benefit has Neoclarityn shown during the studies?
X' benefiċċju wera Neoclarityn matul l- istudji?
In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Neoclarityn 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' Neoclarityn 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 Neoclarityn 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' Neoclarityn, 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 Neoclarityn?
X' inhu r- riskju assoċjat ma 'Neoclarityn?
For the full list of all side effects reported with Neoclarityn, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Neoclarityn, ara l- Fuljett ta' Tagħrif.
Neoclarityn should not be used in people who may be hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Neoclarityn ma 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 Neoclarityn been approved?
Għaliex ġie approvat Neoclarityn?
The Committee for Medicinal Products for Human Use (CHMP) decided that Neoclarityn’ 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 'Neoclarityn fis- serħan mis- sintomi assoċjati mar- rinite allerġika jew ma' l- urtikarja huma akbar mir - riskji.
The Committee recommended that Neoclarityn be given marketing authorisation.
Il- Kumitat irrakkomanda li Neoclarityn jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Neoclarityn:
Aktar tagħrif dwar Neoclarityn:
The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn to SP Europe on 15 January 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Neoclarityn lil SP Europe fil- 15 ta 'Jannar 2001.
The full EPAR for Neoclarityn is available here.
L- EPAR sħiħ dwar Neoclarityn jista 'jiġi kkonsultat hawn.
EU/ 1/ 00/ 161/ 001 EU/ 1/ 00/ 161/ 002 EU/ 1/ 00/ 161/ 003 EU/ 1/ 00/ 161/ 004 EU/ 1/ 00/ 161/ 005 EU/ 1/ 00/ 161/ 006 EU/ 1/ 00/ 161/ 007 EU/ 1/ 00/ 161/ 008 EU/ 1/ 00/ 161/ 009 EU/ 1/ 00/ 161/ 010 EU/ 1/ 00/ 161/ 011 EU/ 1/ 00/ 161/ 012 EU/ 1/ 00/ 161/ 013
Numru ta ’ l- EU EU/ 1/ 00/ 161/ 001 EU/ 1/ 00/ 161/ 002 EU/ 1/ 00/ 161/ 003 EU/ 1/ 00/ 161/ 004 EU/ 1/ 00/ 161/ 005 EU/ 1/ 00/ 161/ 006 EU/ 1/ 00/ 161/ 007 EU/ 1/ 00/ 161/ 008 EU/ 1/ 00/ 161/ 009 EU/ 1/ 00/ 161/ 010 EU/ 1/ 00/ 161/ 011 EU/ 1/ 00/ 161/ 012 EU/ 1/ 00/ 161/ 013
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
Isem inventat Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
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
Qawwa 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
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Għamla farmaċewtika Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali 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
Mnejn jingħata Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu) blister (Aclar/ PVC, alu)
Il- pakkett folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu) folji (Aclar/ PVC, alu)
1 tablet 2 tablets 3 tablets 5 tablets 7 tablets 10 tablets 14 tablets 15 tablets 20 tablets 21 tablets 30 tablets 50 tablets 100 tablets
Daqs tal- pakkett pillola 1 2 pilloli 3 pilloli 5 pilloli 7 pilloli 10 pilloli 14- il pillola 15- il pillola 20 pillola 21 pillola 30 pillola 50 pillola 100 pillola
EU/ 1/ 00/ 161/ 014 EU/ 1/ 00/ 161/ 015 EU/ 1/ 00/ 161/ 016 EU/ 1/ 00/ 161/ 017 EU/ 1/ 00/ 161/ 018 EU/ 1/ 00/ 161/ 019 EU/ 1/ 00/ 161/ 020 EU/ 1/ 00/ 161/ 021 EU/ 1/ 00/ 161/ 022 EU/ 1/ 00/ 161/ 023 EU/ 1/ 00/ 161/ 024 EU/ 1/ 00/ 161/ 025 EU/ 1/ 00/ 161/ 026 EU/ 1/ 00/ 161/ 027 EU/ 1/ 00/ 161/ 028 EU/ 1/ 00/ 161/ 029 EU/ 1/ 00/ 161/ 030 EU/ 1/ 00/ 161/ 031 EU/ 1/ 00/ 161/ 032
EU/ 1/ 00/ 161/ 014 EU/ 1/ 00/ 161/ 015 EU/ 1/ 00/ 161/ 016 EU/ 1/ 00/ 161/ 017 EU/ 1/ 00/ 161/ 018 EU/ 1/ 00/ 161/ 019 EU/ 1/ 00/ 161/ 020 EU/ 1/ 00/ 161/ 021 EU/ 1/ 00/ 161/ 022 EU/ 1/ 00/ 161/ 023 EU/ 1/ 00/ 161/ 024 EU/ 1/ 00/ 161/ 025 EU/ 1/ 00/ 161/ 026 EU/ 1/ 00/ 161/ 027 EU/ 1/ 00/ 161/ 028 EU/ 1/ 00/ 161/ 029 EU/ 1/ 00/ 161/ 030 EU/ 1/ 00/ 161/ 031 EU/ 1/ 00/ 161/ 032 EU/ 1/ 00/ 161/ 033 EU/ 1/ 00/ 161/ 034 EU/ 1/ 00/ 161/ 035 EU/ 1/ 00/ 161/ 036 EU/ 1/ 00/ 161/ 037 EU/ 1/ 00/ 161/ 038
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
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 5 mg
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 5 mg 5 mg 5 mg 2. 5 mg 2. 5 mg 2. 5 mg 2. 5 mg
Syrup Syrup Syrup Syrup Syrup Syrup Syrup Syrup Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate Oral lyophilisate
Mistura Mistura Mistura Mistura Mistura Mistura Mistura Mistura Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Lajofiliżejt orali Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq
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 Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu 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) blister (PVC/ Alu)
flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) flixkun (ħġieġ) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ Alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu)
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 30
flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall flixkun 1, mgħarfa għall 1 2 3 5 7 10 14 15 20 21 30 50 100 5 pilloli 6 pilloli 10 pilloli 12- il pillola
1/ 3 EU/ 1/ 00/ 161/ 033 EU/ 1/ 00/ 161/ 034 EU/ 1/ 00/ 161/ 035 EU/ 1/ 00/ 161/ 036 EU/ 1/ 00/ 161/ 037 EU/ 1/ 00/ 161/ 038 EU/ 1/ 00/ 161/ 039 EU/ 1/ 00/ 161/ 040 EU/ 1/ 00/ 161/ 041 EU/ 1/ 00/ 161/ 042 EU/ 1/ 00/ 161/ 043 EU/ 1/ 00/ 161/ 044 EU/ 1/ 00/ 161/ 045 EU/ 1/ 00/ 161/ 046 EU/ 1/ 00/ 161/ 047 EU/ 1/ 00/ 161/ 048 EU/ 1/ 00/ 161/ 049 EU/ 1/ 00/ 161/ 050 EU/ 1/ 00/ 161/ 051 EU/ 1/ 00/ 161/ 052 EU/ 1/ 00/ 161/ 053 EU/ 1/ 00/ 161/ 054 EU/ 1/ 00/ 161/ 055 EU/ 1/ 00/ 161/ 056 EU/ 1/ 00/ 161/ 057 EU/ 1/ 00/ 161/ 058
1/ 2 EU/ 1/ 00/ 161/ 039 EU/ 1/ 00/ 161/ 040 EU/ 1/ 00/ 161/ 041 EU/ 1/ 00/ 161/ 042 EU/ 1/ 00/ 161/ 043 EU/ 1/ 00/ 161/ 044 EU/ 1/ 00/ 161/ 045 EU/ 1/ 00/ 161/ 046 EU/ 1/ 00/ 161/ 047 EU/ 1/ 00/ 161/ 048 EU/ 1/ 00/ 161/ 049 EU/ 1/ 00/ 161/ 050 EU/ 1/ 00/ 161/ 051 EU/ 1/ 00/ 161/ 052 EU/ 1/ 00/ 161/ 053 EU/ 1/ 00/ 161/ 054 EU/ 1/ 00/ 161/ 055 EU/ 1/ 00/ 161/ 056 EU/ 1/ 00/ 161/ 057 EU/ 1/ 00/ 161/ 058
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn Neoclarityn
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
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
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
Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq Pillola li tinħall fil- ħalq
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 Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
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)
folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu) folja (PVC/ OPA/ alu)
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
15- il pillola 18- il pillola 20 pillola 30 pillola 50 pillola 60 pillola 90 pillola 100 pillola 5 pilloli 6 pilloli 10 pilloli 12- il pillola 15- il pillola 18- il pillola 20 pillola 30 pillola 50 pillola 60 pillola 90 pillola 100 pillola
bottle (glass) + syringe (plastic)
flixkun (ħġieġ) + kuċċarina (plastik)
Neoclarityn 5 mg film-coated tablets
Neoclarityn 5 mg pilloli miksija b’ rita
Neoclarityn is indicated for the relief of symptoms associated with:
Neoclarityn jintuża biex jittaffew is- sintomi assoċjati ma ’:
Efficacy and safety of Neoclarityn tablets in children under 12 years of age have not been established.
L- effikaċja u s- sigurtà tal- pilloli Neoclarityn fi tfal taħt it- tnax- il sena ma ġewx stabbiliti.
In the case of severe renal insufficiency, Neoclarityn should be used with caution (see section 5.2).
F’ każ ta ’ insuffiċjenza renali severa, Neoclarityn għandu jintuża b’ attenzjoni (ara sezzjoni 5. 2).
In a clinical pharmacology trial Neoclarityn taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Fi prova farmakoloġika klinika, pilloli Neoclarityn li ttieħdu flimkien ma ’ alkoħol ma żiedux l- effetti li jxekklu l- prestazzjoni ta ’ l- alkoħol (ara sezzjoni 5. 1).
The use of Neoclarityn during pregnancy is therefore not recommended.
L- użu ta ’ Neoclarityn waqt it- tqala għaldaqstant mhuwiex irrakkomandat.
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breast-feeding women.
Desloratidine joħroġ fil- ħalib tas- sider, għaldaqstant l- użu ta ’ desloratidine mhuwiex rakkomandat f’ nisa li qed ireddgħu.
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3% of patients in excess of those treated with placebo.
Fi provi kliniċi ta ’ medda ta ’ indikazzjonijiet fosthom rajnajtis allerġiku u urtikarja idjopatika kronika, bid- doża rakkomandata ta ’ 5 mg kuljum, l- effetti mhux mixtieqa b’ Neoclarityn kien rappurtati fi 3% tal- pazjenti aktar minn dawk fuq plaċebo.
Neoclarityn given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Neoclarityn mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg ma effettwax il - prestazzjonijiet psikomotriċi fi provi kliniċi.
In patients with allergic rhinitis, Neoclarityn was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
F’ pazjenti b ’ rajnajtis allerġiku, Neoclarityn, kien effettiv biex iserrħu sintomi bħal għatis, tnixxija mill- imnieħer, u hakk, kif ukoll ħakk, dmugħ u ħmura fl- għajnejn, u ħakk fis- saqaf tal- ħalq.
Neoclarityn effectively controlled symptoms for 24 hours.
Neoclarityn itaffi b’ mod effettiv s- sintomi għal 24 siegħa.
The efficacy of Neoclarityn tablets has not been clearly demonstrated in trials with adolescent patients 12 through 17 years of age.
L- effikaċja tal- pilloli Neoclarityn ma ntwerietx b’ mod ċar fi provi bi pazjenti adolexxenti minn 12 sa 17- il sena.
Neoclarityn was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
4 Neoclarityn kien effettiv biex iserraħ il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mil- punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.
The greatest amelioration was seen in the domains of practical problems and daily activities limited by symptoms.
L- akbar titjib deher fil- qasam ta ’ problemi prattiċi u attivitaiet ta ’ kuljum limitati mis- sintomi.
4 In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
F’ żewġ provi kkontrollati bi plaċebo li damu sitt ġimgħat f’ pazjenti b’ urtikarja kronika idjopatika, Neoclarityn kien effettiv biex iserraħ il- ħakk u jnaqqas id- daqs u n- numru ta ’ ħbiebes fl- aħħar ta ’ l - ewwel intervall tad- dożaġġ.
Treatment with Neoclarityn also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Kura b’ Neoclarityn tejjbet ukoll b’ mod sinjifikanti in- nuqqas ta ’ rqad u funzjoni ta ’ matul il- jum, kif imkejjel bi skala b’ erba ’ punti li tintuża biex tevalwa dawn il- varjanti.
Neoclarityn is supplied in unit dose blisters comprised of laminant blister film with foil lidding.
Neoclarityn issibu ġo folja għal kull doża li tikkonsisti f’ rita llaminata tal- folji magħluqa bil- fojl.
Packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 tablets.
Pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 100 pillola.
Neoclarityn 0.5 mg/ ml syrup
Neoclarityn 0. 5 mg/ ml mistura
Neoclarityn may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria (see section 5.1).
Neoclarityn jista ’ jittieħed mingħajr ma jingħata każ għall- ħin ta ’ l- ikel għas- serħan mis- sintomi assoċjati ma ’ rajnajtis allerġiku (inkluż rajnajtis allerġiku intermittenti u dak persistenti) u urtikarja (ara sezzjoni 5. 1).
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin (see section 4.4) and there are no data supporting the treatment of infectious rhinitis with Neoclarityn.
Min jordna din il- mediċina għandu jżomm f’ rasu li ħafna mill- każijiet ta ’ rajnajtis taħt is- sentejn ikunu ġejjin min infezzjoni (ara sezzjoni 4. 4) u m’ hemmx tagħrif li juri li Neoclarityn huwa tajjeb għal kura ta ’ rajnajtis ta ’ l- infezzjoni.
2.5 ml (1.25 mg) Neoclarityn syrup once a day.
2. 5 ml (1. 25 mg) Neoclarityn mistura darba kuljum.
5 ml (2.5 mg) Neoclarityn syrup once a day.
5 ml (2. 5 mg) Neoclarityn mistura darba kuljum.
10 ml (5 mg) Neoclarityn syrup once a day.
Adulti u adolexxenti (minn 12- il sena ‘ l fuq): 10 ml (5 mg) Neoclarityn mistura darba kuljum.
Efficacy and safety of Neoclarityn syrup in children under 1 year of age have not been established.
L- effikaċja u s- sigurtà tal- mistura Neoclarityn fi tfal li għandhom anqas minn sena ma ġewx stabbiliti.
The safety of Neoclarityn syrup in children 2- to 11-years of age who are poor metabolisers is the same as in children who are normal metabolisers.
Is- sigurtà ta ’ desloratadine fi tfal ta ’ etajiet bejn 2 u 11- il sena li huma metabolizzaturi dgħajfin hija l- istess bħal dik fi tfal li huma metabolizzaturi normali.
The effects of Neoclarityn syrup in poor metabolisers < 2 years of age have not been studied.
L- effetti ta ’ desloratadine f’ metabolizzaturi dgħajfin li għandhom < sentejn ma ġewx studjati.
No clinically relevant interactions were observed in clinical trials with Neoclarityn tablets in which erythromycin or ketoconazole were co-administered (see section 5.1).
Ma dehrux interazzjonijiet klinikament rilevanti waqt provi kliniċi bil- pilloli desloratadine li fihom ingħataw erythromycin jew ketoconazole fl- istess ħin (ara sezzjoni 5. 1).
In a clinical pharmacology trial, Neoclarityn tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Fi prova farmakoloġika klinika, pilloli Neoclarityn li ttieħdu flimkien ma ’ alkoħol ma żiedux l- effetti li jxekklu l- prestazzjoni ta ’ l- alkoħol (ara sezzjoni 5. 1).
Desloratadine is excreted into breast milk, therefore the use of Neoclarityn is not recommended in breastfeeding women.
Desloratidine joħroġ fil- ħalib tas- sider, għaldaqstant l- użu ta ’ desloratidine mhuwiex rakkomandat f’ nisa li qed ireddgħu.
In clinical trials in a paediatric population, Neoclarityn syrup was administered to a total of 246 children aged 6 months through 11 years.
Fi provi kliniċi f’ popolazzjoni pedjatrika, il- formulazzjoni ta ’ mistura ta ’ desloratadine ingħatat b’ kollox lill- 246 tifel u tifla ta ’ etajiet minn 6 xhur sa 11- il sena.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Neoclarityn syrup and the placebo groups.
L- inċidenza globali ta ’ każijiet avversi fi tfal minn sentejn sa 11- il sena kienet simili għal gruppi fuq desloratadine u dawk fuq plaċebo.
At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Neoclarityn were reported in 3% of patients in excess of those treated with placebo.
Fi provi kliniċi ta ’ medda ta ’ indikazzjonijiet fosthom rajnajtis allerġiku u urtikarja idjopatika kronika, bid- doża rakkomandata ta ’ 5 mg kuljum, l- effetti mhux mixtieqa b’ Neoclarityn kien
Other undesirable effects reported very rarely during the post-marketing period are listed in the following table.
Effetti mhux mixtieqa oħrajn li ġew rappurtati rari ħafna fil- perijodu ta ’ wara t- tqegħid fis- suq huma elenkati fit- tabella li ġejja.
9 Psychiatric disorders Nervous system disorders
4. 9 Doża eċċessiva
Efficacy of Neoclarityn syrup has not been investigated in separate paediatric trials.
L- effikaċja tal- mistura Neoclarityn ma ġietx investigata fi provi pedjatriċi separati.
Safety of Neoclarityn syrup was demonstrated in three paediatric trials.
Żewġ studji pedjatriċi wrew is- sigurtà tal- mistura Neoclarityn.
When given at the recommended doses, the plasma concentrations of desloratadine (see section 5.2) were comparable in the paediatric and adult populations.
Meta ingħata bid- dożi rrakkomandati, il - konċentrazzjonijiet ta ’ desloratadine fil- plażma (ara sezzjoni 5. 2) kienu komparabbli fil -
10 Desloratadine does not readily penetrate the central nervous system.
Desloratadine ma jippenetrax malajr fis- sistema nervuża ċentrali.
In controlled clinical trials, at the recommended dose of 5 mg daily for adults and adolescents, there was no excess incidence of somnolence as compared to placebo.
Fi provi kliniċi bid- doża rakkomandata ta ’ 5 mg kuljum għall- adulti u adolexxenti, il- każijiet ta ’ dawk li qabadhom ngħas żejjed ma kienux aktar meta mqabbla mal- plaċebo.
Neoclarityn tablets given at a single daily dose of 7.5 mg to adults and adolescents did not affect psychomotor performance in clinical trials.
Il- pilloli Neoclarityn mogħtija bħala doża waħda kuljum ta ’ 7. 5 mg lill- adulti u adolexxenti ma effettwax il- prestazzjonijiet psikomotriċi fi provi kliniċi.
Efficacy of Neoclarityn syrup has not been investigated in paediatric trials in children less than 12 years of age.
L- effikaċja tal- mistura Neoclarityn ma ġiext investigata fi provi pedjatriċi fi tfal ta ’ taħt it- 12- il sena.
In adult and adolescent patients with allergic rhinitis, Neoclarityn tablets were effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
F ’ pazjenti adulti u adolexxenti b’ rajnajtis allerġiku, il- pilloli Neoclarityn, kienu effettivi biex iserrħu sintomi bħal għatis, tnixxija mill- imnieħer u ħakk, kif ukoll ħakk, dmugħ u ħmura fl- għajnejn, u ħakk fis- saqaf tal- ħalq.
Neoclarityn tablets were effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Il- pilloli Neoclarityn kienu effettivi biex iserrħu il- problemi relatati ma ’ rajnajtis allerġiku ta ’ l- istaġun kif jidher mil- punteġġ totali tal- kwestjonarju fuq il- kwalità tal- ħajja b’ rajno- konġunktivite.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Neoclarityn was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
F’ żewġ provi kkontrollati bi plaċebo li damu sitt ġimgħat f’ pazjenti b’ urtikarja kronika idjopatika, Neoclarityn kien effettiv biex iserraħ il- ħakk u jnaqqas id- daqs u n- numru ta ’ ħbiebes fl- aħħar ta ’ l - ewwel intervall tad- dożaġġ.
An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of patients treated with placebo.
Kura b’ Neoclarityn
Treatment with Neoclarityn also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
11 tejjbet ukoll b’ mod sinjifikanti in- nuqqas ta ’ rqad u funzjoni ta ’ matul il- jum, kif imkejjel bi skala b’ erba ’ punti li tintuża biex tevalwa dawn il- varjanti.
11 In a series of pharmacokinetic and clinical trials, 6% of the subjects reached a higher concentration of desloratadine.
F’ serje ta ’ provi farmakokinetiċi u kliniċi, 6% ta ’ l- individwi kisbu konċentrazzjoni ogħla ta ’ desloratadine.