qanastek/EMEA-V3 huggingface dataset:
Film-coated tablet [To be completed nationally.]
Pillola miksija b’ rita
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHU UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
92 [To completed nationally.]
[Biex timtela mill- pajjiż partikolari.]
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
98 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton for Foil/ Foil blister (PVC-Al-Polyamide/ 4511 heat seal coating/ A1-polyester paper)
Kartuna għall- Fojl/ Folja tal- Fojl (PVC- Al- Polyamide/ 4511 kisja issiġillata bis- sħana/ A1- karta tal - polyester)
RISPERDAL and associated names (see Annex I) 0.5 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 1 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 2 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 3 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 4 mg orodispersible tablets
RISPERDAL u ismijiet assocjati miegħu (Ara Anness I) pilloli ta ’ 0. 5 mg jinħallu fil- ħalq RISPERDAL u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 1 mg jinħallu fil- ħalq RISPERDAL u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 2 mg jinħallu fil- ħalq RISPERDAL u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 3 mg jinħallu fil- ħalq RISPERDAL u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 4 mg jinħallu fil- ħalq
Orodispersible tablet [To be completed nationally]
Pillola li tinħall fil- ħalq [Biex timtela mill- pajjiż partikolari]
Peel open the blister and tip the tablet out Do not push the tablet through the foil Melts on the tongue.
Iftaħ il- folja billi tqaxxarha u mejjel fuq naħa waħda biex il- pillola toħroġ il- barra Timbuttax il- pillola minn ġol- fojl Tinħall fuq l- ilsien.
95 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
100 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton for Film/ Foil Blister (PVC-PE-PCTFE/ Al blister)
Kartuna għar- Rita/ Folja tal- Fojl (Folja PVC- PE- PCTFE/ A)
Orodispersible tablet [To be completed nationally]
[Biex timtela mill- pajjiż partikolari]
97 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
102 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Foil/ Foil blister (PVC-Al-Polyamide/ 4511 heat seal coating/ A1-polyester paper) Film/ Foil Blister (PVC-PE-PCTFE/ Al blister)
Fojl/ Folja tal- Foil (PVC- Al- Polyamide/ 4511 kisja ssiġillata bis- sħana / A1- karta tal- polyester) Rita/ Folja tal- Foil (folja PVC- PE- PCTFE/ Al)
98 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
103 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton for amber glass bottle
Kartuna għall- flixkun tal- ħġieġ kulur l- ambra
RISPERDAL and associated names (see Annex I) 1 mg/ ml oral solution
RISPERDAL u ismijiet assoċjati miegħu (ara Anness I) 1 mg/ ml soluzzjoni orali
Administration:
Kif jingħata:
To facilitate accurate measurement, use the enclosed calibrated pipette or a graduated measure.
Biex tkejjel faċilment b’ mod preċiż, uża l- pipetta kkalibrata li hemm miegħu jew kejl ggradwat.
Use within 3 months of first opening.
JIS Uża fi żmien 3 xhur minn meta tiftħu l- ewwel darba.
100 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
105 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
amber glass bottle
flixkun tal- ħgieġ kulur l- ambra
Use within 3 months of first opening.
Uża fi żmien 3 xhur minn meta tiftħu l- ewwel darba.
Date opened……..
Data meta nfetaħ ………..
102 PACKAGE LEAFLET
107 FULJETT TA ’ TAGĦRIF
103 PACKAGE LEAFLET:
108 FULJETT TA ’ TAGĦRIF:
0.5, 1, 2, 3 and 4 mg orodispersible tablets RISPERDAL and associated names (see Annex I) 1 mg/ ml oral solution [See Annex I – To be completed nationally) Risperidone
RISPERDAL u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b’ rita ta ’ 0. 25, 0. 5, 1, 2, 3, 4 u 6 mg RISPERDAL Quicklet u ismijiet assoċjati miegħu (Ara Anness I): pilloli jinħallu fil- ħalq ta ’ 0. 5, 1, 2, 3 u 4 mg orodispersible tablets RISPERDAL u ismijiet assoċjati miegħu (Ara Anness I) soluzzjoni orali 1 mg/ ml [Ara Anness I – Biex timtela mill- pajjiż partikolari] Risperidone
What RISPERDAL is and what it is used for 2.
X’ inhu RISPERDAL u għalxiex jintuża 2.
Before you take RISPERDAL 3.
Qabel ma tieħu RISPERDAL 3.
How to take RISPERDAL 4.
Kif għandek tieħu RISPERDAL 4.
How to store RISPERDAL 6.
Kif taħżen RISPERDAL 6.
WHAT RISPERDAL IS AND WHAT IT IS USED FOR
X’ inhu RISPERDAL u għalxiex jintuża
RISPERDAL belongs to a group of medicines called ‘ anti-psychotics’.
RISPERDAL tagħmel parti minn grupp ta ’ mediċini imsejħa ‘ anti- psikotiċi ’.
RISPERDAL is used to treat the following:
RISPERDAL jintuża biex jikkura dawn li ġejjin:
• Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused • Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive Mania occurs in an illness called “ bipolar disorder” • Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’ s dementia, who harm themselves or others.
Manija sseħħ f’ marda imsejħa “ disturb bipolari ” • Kura għal żmien qasir (sa 6 ġimgħat) ta ’ agressjoni li ilha preżenti f’ persuni li jbatu bid - dimenzja ta ’ Alzheimer li jagħmlu ħsara lilhom infushom.
Alternative (non-drug) treatments should have been used previously • Short-term treatment (up to 6 weeks) of long-term, aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder.
It- trattamenti alternattivi (mingħajr drogi) għandhom ikunu intużaw qabel. • Kura għal żmien qasir (sa 6 ġimgħat) ta ’ agressjoni li ilha preżenti fi tfal b’ diżabilità intellettwali (ta ’ età ta ’ mill- anqas 5 snin) u adoloxxenti b’ disturb fl- imġiba
BEFORE YOU TAKE RISPERDAL
Qabel ma tieħu RISPERDAL
Do not take RISPERDAL if: • You are allergic (hypersensitive) to risperidone or any of the other ingredients of RISPERDAL (listed in Section 6 below).
Tieħux RISPERDAL jekk: • Inti allerġiku (tbagħti minn sensittività eċċessiva għal risperidone jew għal xi wieħed mis - sustanzi l- oħra ta ’ RISPERDAL (elenkati f’ Sezzjoni 6 hawn taħt).
If you are not sure if the above applies to you, talk to your doctor or pharmacist before using RISPERDAL.
Jekk m’ intix ċert/ a jekk dan t’ hawn fuq japplikax għalik, tkellem mat- tabib jew l- ispiżjar tiegħek qabel tuża RISPERDAL.
Take special care with RISPERDAL Check with your doctor or pharmacist before taking RISPERDAL if:
Oqogħod attent ħafna b ’ RISPERDAL Iċċekkja mat- tabib jew l- ispiżjar tiegħek qabel tieħu RISPERDAL jekk:
104 • You have a heart problem.
109 • Inti għandek problema f’ qalbek.
Examples include an irregular heart rhythm or if you are prone to low blood pressure or if you are using medicines for your blood pressure.
Eżempji jinkludu ritmu irregolari tal- qalb, jew jekk inti għandek tendenza li tinżillek il- pressjoni jew jekk inti qed tuża mediċini għall- pressjoni.
RISPERDAL may cause low blood pressure.
RISPERDAL jista ’ jikkawża pressjoni baxxa.
Your dose may need to be adjusted • You know of any factors which would favour you having a stroke, such as high blood pressure, cardiovascular disorder or blood vessel problems in the brain • You have Parkinson’ s disease or dementia • You are diabetic • You have epilepsy • You are a man and you have ever had a prolonged or painful erection If you experience this while taking RISPERDAL, contact your doctor straight away • You have problems controlling your body temperature or overheating • You have kidney problems • You have liver problems • You have an abnormally high level of the hormone prolactin in your blood or if you have a tumour, which is possibly dependent on prolactin.
Jekk tesperjenza dan waqt li qed tieħu RISPERDAL, ikkuntattja lit- tabib tiegħek mill- ewwel. • Inti għandek problemi biex tikkontrolla t- temperatura ta ’ ġismek jew ġismek jisħon iż- żejjed • Inti għandek problemi fil- kliewi • Inti għandek problemi fil- fwied • Inti għandek livelli għolja b’ mod mhux normali ta ’ l- ormon prolactin fid- demm jew jekk inti għandek tumur, li jista ’ jkun li huwa dipendenti mill- prolactin
Tell your doctor immediately if you experience • involuntary rhythmic movements of the tongue, mouth and face.
Għid lit- tabib tiegħek mill- ewwel jekk ikollok • movimenti involuntarji ritmiċi ta ’ l- ilsien, tal- ħalq u tal- wiċċ.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL.
Jekk m’ intix ċert/ a jekk xi waħda minn dawn tapplikax għalik, tkellem mat- tabib jew l- ispiżjar tiegħek qabel tuża RISPERDAL.
RISPERDAL may cause you to gain weight.
RISPERDAL jista ’ jġgħalek iżżid fil- piż.
Elderly people with dementia In elderly patients with dementia, there is an increased risk of stroke.
Persuni anzjani bid- dimenzja F’ pazjenti anzjani bid- dimenzja, hemm riskju akbar ta ’ puplesija.
You should not take risperidone if you have dementia caused by stroke.
Inti m’ għandekx tieħu risperidone jekk għandek id- dimenzja ikkawżata minn puplesija.
During treatment with risperidone you should frequently see your doctor.
Waqt il- kura b’ risperidone inti għandek tara lit- tabib tiegħek b’ mod frekwenti.
Medical treatment should be sought straight away if you or your care-giver notice a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
Kura medika għanda tiġi mfittxija immedjatament jekk inti jew il- persuna li tieħu ħsiebek tinnota tibdil f’ daqqa waħda fl- istat mentali tiegħek jew jekk f’ daqqa waħda tħoss dgħjufija fil- wiċċ, fid - dirgħajn jew fis- saqajn, jew tħosshom imtarrxin, speċjalment fuq naħa waħda, jew jekk il- kliem ma ’ jiftehemx, anke għal perjodu qasir ta ’ żmien.
Children and adolescents Before treatment is started in conduct disorder, other causes of aggressive behaviour should have been ruled out.
Tfal u adoloxxenti Qabel ma tinbeda l- kura f’ disturb ta ’ l- imġiba, kawżi oħra ta ’ komportament aggressiv iridu jiġu esklużi.
If during treatment with risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Jekk waqt il- kura b’ risperidone ikun hemm għeja, bidla fil- ħin li fih jingħata jista ’ jtejjeb diffikultajiet fl- attenzjoni.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inkluż mediċini li ksibt mingħajr riċetta u mediċini magħmula mill- ħxejjex.
It is especially important to talk to your doctor or pharmacist if you are taking any of the following: • Medicines that work on your brain such as to help you calm down (benzodiazepines) or some medicines for pain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these • Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems • Medicines that cause a slow heart beat • Medicines that cause low blood potassium (e. g. certain diuretics) • Medicines to treat elevated blood pressure.
Huwa speċjalment importanti li tkellem lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu xi waħda minn dawn li ġejjin: • Mediċini li jaħdmu fuq moħħok bħal dawk li jgħinuk tikkalma (benzodiazepines), jew xi mediċini għall- uġigħ (opiates), mediċini għall- allerġija (xi anti- istaminiċi), minħabba li risperidone jista ’ jżid l- effett sedattiv ta ’ dawn kollha • Mediċini li jistgħu jibdlu l- attività ta ’ l- elettriku ta ’ qalbek, bħal mediċini għall- malarja, tal - problemi fir- ritmu tal- qalb (bħal quinidine), ta ’ l- allerġiji (anti- istaminiċi) xi antidepressanti jew mediċini oħra għall- problemi mentali • Mediċini li jikkawżaw taħbit bil- mod tal- qalb • Mediċini li jikkawżaw potassium baxx fid- demm (eż. ċerti dijuretiċi) 110 • Mediċini li jikkuraw pressjoni għolja.
RISPERDAL can lower blood pressure • Medicines for Parkinson's disease (such as levodopa) 105 • Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too much fluid (such as furosemide or chlorothiazide).
RISPERDAL jista ’ jbaxxi l- pressjoni • Mediċini għall- marda ta ’ Parkinson (bħal levodopa) • Pilloli tal- pipì (dijuretiċi) użati għall- problemi tal- qalb jew nefħa f’ xi parti ta ’ ġismek minħabba li jinġabar fluwidu żejjed (bħal furosemide jew chlorothiazide).
RISPERDAL taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.
RISPERDAL meta jittieħed waħdu jew ma ’ furosemide, jista ’ joħloq riskju ogħla ta ’ puplesija jew mewt f’ persuni anzjani bid- dimenzja.
The following medicines may reduce the effect of risperidone • Rifampicin (a medicine for treating some infections) • Carbamazepine, phenytoin (medicines for epilepsy) • Phenobarbital If you start or stop taking such medicines you may need a different dose of risperidone.
Il- mediċini li ġejjin jistgħu jnaqqsu l- effett ta ’ risperidone • Rifampicin (mediċina li tikkura xi infezzjonijiet) • Carbamazepine, phenytoin (mediċini għall- epilessija) • Phenobarbital Jekk tibda tieħu jew tieqaf tieħu mediċini bħal dawn inti jista ’ jkollok bżonn doża differenti ta ’ risperidone.
The following medicines may increase the effect of risperidone • Quinidine (used for certain types of heart disease) • Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants • Medicines known as beta blockers (used to treat high blood pressure) • Phenothiazines (e. g. used to treat psychosis or to calm down) • Cimetidine, ranitidine (blockers of the acidity of stomach) If you start or stop taking such medicines you may need a different dose of risperidone.
Il- mediċini li ġejjin jistgħu jżidu l- effett ta ’ risperidone • Quinidine (użat għal ċerti tipi ta ’ mard tal- qalb) • Antidepressanti bħal paroxetine, fluoxetines, antidepressanti triċikliċi • Mediċini magħrufa bħala beta blockers (użati biex jikkuraw il- pressjoni għolja) • Phenothiazines (eż. użati biex jikkuraw psikożi jew biex tikkalma) • Cimetidie, ranitidine (imblokkaturi ta ’ l- aċidu ta ’ l- istonku) Jekk tibda tieħu jew tieqaf tieħu mediċini bħal dawn inti jista ’ jkollok bżonn doża differenti ta ’ risperidone
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL.
Jekk m’ intix ċert jekk xi waħda minn dawn t’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill - ispiżjar tiegħek qabel tuża RISPERDAL.
Taking RISPERDAL with food and drink You can take this medicine with or without food.
Meta tieħu RISPERDAL ma ’ l- ikel jew max- xorb Tista ’ tieħu din il- mediċina ma ’ l- ikel jew mingħajru.
You should avoid drinking alcohol when taking RISPERDAL.
Għandek tevita li tixrob l- alkoħol meta tieħu RISPERDAL.
Pregnancy and breast-feeding • Talk to your doctor before using RISPERDAL if you are pregnant, trying to become pregnant or breast-feeding.
Tqala u treddigħ • Kellem lit- tabib tiegħek qabel tuża RISPERDAL jekk inti tqila, qed tipprova toħroġ tqila jew qed tredda ’.
Your doctor will decide if you can take it • Shaking, muscle stiffness and problems feeding, all of which are reversible, have been seen in newborn babies when RISPERDAL was used during the last trimester of pregnancy.
It- tabib tiegħek jiddeċiedi jekk tistax toħodha • Rogħda, ebusija fil- muskoli u problemi biex jixorbu, li kollha kemm huma kienu riversibbli, intwerew fit- trabi tat- twelid meta RISPERDAL intuża fl- aħħar trimestru tat- tqala.
Driving and using machines Dizziness, tiredness, and vision problems may occur during treatment with RISPERDAL.
Sewqan u tħaddim ta ’ magni Sturdament, għejja, u problemi bil- vista jistgħu jseħħu waqt kura b’ RISPERDAL.
Important information about some of the ingredients of RISPERDAL
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ RISPERDAL
HOW TO TAKE RISPERDAL
Kif għandek tieħu RISPERDAL
How much to take
Kemm għandek tieħu
For the treatment of schizophrenia
Għall- kura ta ’ skizofrenja
Adults • The usual starting dose is 2 mg per day, this may be increased to 4 mg per day on the second day • Your dose may then be adjusted by your doctor depending on how you respond to the treatment • Most people feel better with daily doses of 4 to 6 mg • This total daily dose can be divided into either one or two doses a day.
111 • Id- doża tiegħek tista ’ tiġi aġġustata mit- tabib tiegħek skond kif tirrispondi għall- kura. • Il- biċċa l- kbira tal- persuni jħossuhom aħjar b’ dożi ta ’ 4 sa 6 mg kuljum • Din id- doża totali kuljum tista ’ tittieħed f’ daqqa jew tinqasam f’ żewġ dożi kuljum.
Your doctor will tell you which is the best for you.
It- tabib tiegħek jgħidlek liema huwa l- aħjar għalik.
106 Elderly people • Your starting dose will normally be 0.5 mg twice a day • Your dose may then be gradually increased by your doctor to 1 mg to 2 mg twice a day • Your doctor will tell you which is the best for you.
Persuni anzjani • Id- doża li se tibda biha normalment tkun ta ’ 0. 5 mg darbtejn kuljum • Id- doża tiegħek tista ’ imbagħad tiżdied bil- mod il- mod mit- tabib tiegħek għal 1 mg sa 2 mg darbtejn kuljum • It- tabib tiegħek jgħidlek liema huwa l- aħjar għalik.
Children and adolescents • Children and adolescents under 18 years old should not be treated with RISPERDAL for schizophrenia.
Tfal u adoloxxenti • Tfal u adoloxxenti taħt il- 18- il sena m’ għandhomx jiġu kkurati b’ RISPERDAL għal skizofrenja.
For the treatment of mania
Għall- kura ta ’ manija
Adults • Your starting dose will usually be 2 mg once a day • Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment • Most people feel better with doses of 1 to 6 mg once a day.
Adulti • Id- doża li se tibda biha s- soltu tkun 2 mg darba kuljum • Id- doża tiegħek tista ’ imbagħad tkun aġġustata bil- mod il- mod mit- tabib tiegħek skond kif tirrispondi għall- kura • Il- biċċa l- kbira tal- persuni jħossuhom aħjar b’ dożi ta ’ 1 mg sa 6 mg darba kuljum.
Elderly people • Your starting dose will usually be 0.5 mg twice a day • Your dose may then be gradually adjusted by your doctor to 1 mg to 2 mg twice a day depending on how much you respond to the treatment.
Persuni anzjani • Id- doża li inti se tibda biha s- soltu tkun ta ’ 0. 5 mg darbtejn kuljum • Id- doża tiegħek tista ’ mbagħad tkun aġġustata bil- mod il- mod mit- tabib tiegħek għal 1 mg sa 2mg darbtejn kuljum skond kemm inti tirrispondi għall- kura
Children and adolescents • Children and adolescents under 18 years old should not be treated with RISPERDAL for bipolar mania.
Tfal u adoloxxenti • Tfal u adoloxxenti taħt it- 18- il sena m’ għandhomx jiġu kkurati b’ RISPERDAL għall- manija bipolari.
For the treatment of long-standing aggression in people with Alzheimer’ s dementia
Għall- kura ta ’ aggressjoni li ilha għal tul ta ’ żmien f’ persuni bid- dimenzja ta ’ Alzheimer
Adults (including elderly people) • Your starting dose will normally be 0.25 mg twice a day • Your dose may then be gradually adjusted by your doctor depending on how you respond to the treatment • Most people feel better with 0.5 mg twice a day.
Adulti (inkluż persuni anzjani) • Id- doża li tibda biha normalment tkun ta ’ 0. 25 mg darbtejn kuljum • Id- doża tiegħek tista ’ imbagħad tiġi aġġustata bil- mod il- mod mit- tabib tiegħek skond kif tirrispondi għall- kura • Il- biċċa l- kbira tal- persuni jħossuhom aħjar b’ 0. 5 mg darbtejn kuljum.
Some patients may need 1 mg twice a day • Treatment duration in patients with Alzheimer’ s dementia should be not more than 6 weeks.
Xi pazjenti jista ’ jkollhom bżonn 1 mg darbtejn kuljum. • Tul ta ’ żmien ta ’ kura f’ pazjenti bid- dimenzja ta ’ Alzheimer m’ għandux ikun aktar minn 6 ġimgħat.
For the treatment of conduct disorder in children and adolescents
Għall- kura ta ’ disturb fl- imġiba fit- tfal u adoloxxenti
The dose will depend on your child’ s weight:
Id- doża tiddependi fuq il- piż ta ’ ibnek/ bintek:
For children who weigh less than 50 kg • The starting dose will normally be 0.25 mg once a day • The dose may be increased every other day in steps of 0.25 mg per day. • The usual maintenance dose is 0.25 mg to 0.75 mg once a day.
Għal tfal li jiżnu anqas minn 50 kg • Id- doża tal- bidu normalment tkun ta ’ 0. 25 mg darba kuljum • Id- doża tista ’ tiżdied ġurnata iva u oħra le b’ doża ta ’ 0. 25 mg kull ġurnata • Id- doża ta ’ manteniment hija bejn 0. 25 mg u 0. 75 mg darba kuljum.
For children who weigh 50 kg or more • The starting dose will normally be 0.5 mg once a day • The dose may be increased every other day in steps of 0.5 mg per day. • The usual maintenance dose is 0.5 mg to 1.5 mg once a day.
Għal tfal li jiżnu 50 kg jew aktar • Id- doża tal- bidu normalment tkun ta ’ 0. 5 mg darba kuljum • Id- doża tista ’ tiżdied ġurnata iva u oħra le b’ doża ta ’ 0. 5 mg kull ġurnata • Id- doża ta ’ manteniment hija bejn 0. 5 mg u 1. 5 mg darba kuljum.
Treatment duration in patients with conduct disorder should be not more than 6 weeks.
112 It- tul ta ’ żmien ta’ kura f’ pazjenti b’ disturb fl- imġiba ma jridx ikun ta ’ aktar minn 6 ġimgħat.
Children under 5 years old should not be treated with RISPERDAL for conduct disorder.
Tfal taħt il- 5 snin m’ għandhomx jiġu kkurati b’ RISPERDAL għal disturb fl- imġiba.
People with kidney or liver problems Regardless of the disease to be treated, all starting doses and following doses of risperidone should be halved.
Persuni bi problemi fil- kliewi jew fil- fwied Hi x’ hini l- marda li qed tiġi kkurata, id- dożi kollha tal- bidu u dawk li jiġu wara għandhom jitnaqqsu bin- nofs.
Dose increases should be slower in these patients.
Żidiet fid- doża għandhom ikunu aktar bil- mod f’ dawn il- pazjenti.
107 Risperidone should be used with caution in this patient group.
Risperidone għandu jintuża b' attenzjoni f’ dan il- grupp ta ’ pazjenti.
How to take RISPERDAL
Dejjem għandek tieħu RISPERDAL skond il- parir tat- tabib.
Your doctor will tell you how much medicine to take and for how long.
It- tabib jgħidlek kemm tieħu mediċina u għal kemm żmien.
This will depend on your condition and varies from person to person.
Dan jiddependi fuq il- kundizzjoni tiegħek u jvarja minn persuna għal oħra.
The amount of medicine you should take is explained under the ‘ How much to take’ sub-heading below.
L- ammont ta ’ mediċina li għandek tieħu huwa spjegat taħt is - sottotitlu ‘ Kemm għandek tieħu ’ hawn taħt.
RISPERDAL film-coated tablets • You should swallow your tablet with a drink of water
RISPERDAL pilloli miksijin b’ rita • Inti għandek tibla ’ l- pillola tiegħek ma ’ l- ilma
RISPERDAL Quicklet orodispersible tablets Only remove a tablet from the blister when it is time to take your medicine. • Peel open a blister to expose the tablet • Do not push the tablet through the foil because it may break • Remove the tablet from the blister with dry hands • Place the tablet on your tongue straight away • The tablet will begin disintegrating within seconds • It can then be swallowed with or without water.
RISPERDAL Quicklet pilloli li jinħallu fil- ħalq Neħħi l- pillola mill- folja biss meta jasal il- ħin li tieħu l- mediċina. • Qaxxar folja biex tiftaħha u tikxef il- pillola • Timbuttax il- pillola minn ġol- fojl għax tista ’ titfarrak • Neħħi l- pillola mill- folja b’ idejn nexfin • Poġġi l- pillola fuq ilsienek mill- ewwel • Il- pillola tibda ’ tiddiżintegra fi ftit sekondi • Tista ’ imbagħad tiblagħha ma ’ l- ilma jew mingħajru.
RISPERDAL oral solution The solution comes with a syringe (pipette).
RISPERDAL soluzzjoni orali Is- soluzzjoni tiġi b’ siringa (pipetta).
This should be used to help you measure the exact amount of medicine you need.
Din għandha tintuża biex tgħinek tkejjel l- ammont eżatt ta ’ mediċina li għandek bżonn.
Follow these steps:
Segwi dawn il- punti:
Remove the child-proof cap.
Neħħi t- tapp li ma jistgħux jiftħuh it- tfal.
Push the plastic screw cap down while turning it counter clockwise (Figure 1) 2.
Agħafs it- tapp tal- plastik li fih il- kamin l- isfel waqt li ddawru lejn il- lemin (Figura 1) 2.
Insert the syringe into the bottle 3.
Daħħal is- siringa fil- flixkun 3.
While holding the bottom ring, pull the top ring up to the mark that corresponds to the number of millilitres or mg you need to take (Figure 2) 4.
Filwaqt li żżomm iċ- ċirku ta ’ taħt iġbed iċ- ċirku ta ’ fuq sal- marka li taqbel man- numru ta ’ millilitri jew mg li għandek bżonn tieħu (Figura 2) 4.
Holding the bottom ring, remove the entire syringe from the bottle (Figure 3) 5.
Filwaqt li żżomm iċ- ċirku ta ’ taħt neħħi s- siringa kollha mill- flixkun (Figura 3) 5.
Empty the syringe into any non-alcoholic drink, except for tea.
Żerżaq iċ- ċirku ta ’ fuq l - isfel.
Close the bottle 7.
Agħlaq il- flixkun 7.
Rinse the syringe with some water.
Laħlaħ is- siringa bi ftit ilma.
108 If you take more RISPERDAL than you should • See a doctor right away.
113 Jekk tieħu RISPERDAL aktar milli suppost • Ara tabib mill- ewwel.
Take the medicine pack with you • In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits.
Ħu l- pakkett tal- mediċina miegħek. • F’ każ ta ’ doża eċċessiva inti tista ’ tħossok bi ngħas jew għajjien/ a jew ikollok movimenti f’ ġismek mhux normali, problema biex toqogħod bilwieqfa u timxi, tħossok stordut/ a minħabba pressjoni baxxa jew ikollok qalbek ma tħabbatx normali jew aċċessjonijiet.
If you forget to take RISPERDAL • If you forget to take a dose, take it as soon as you remember it.
Jekk tinsa ’ tieħu RISPERDAL • Jekk tinsa ’ tieħu doża ħudha malli tiftakar.
However, if it is almost time for your next dose, skip the missed dose and continue as usual.
Madankollu, jekk ikun kważi wasal il- ħin għad- doża li jmiss, aqbeż id- doża li tkun tlift u kompli bħas- soltu.
If you miss two or more doses, contact your doctor • Do not take a double dose (two doses at the same time) to make up for a forgotten dose
Jekk titlef żewġ dożi jew aktar, ikkuntattja lit- tabib tiegħek. • M’ għandekx tieħu doża doppja (żewġ dożi fl- istess ħin) biex tpatti għal kull doża li tkun insejt
If you stop taking RISPERDAL You should not stop taking this medicine unless told to do so by your doctor.
Jekk tieqaf tieħu RISPERDAL M’ għandekx tieqaf tieħu din il- mediċina sakemm it- tabib tiegħek ma jgħidlekx tagħmel dan.
Your symptoms may return.
Is - sintomi tiegħek jistgħu jerġgħu jitfaċċaw.
If your doctor decides to stop this medicine, your dose may be decreased gradually over a few days.
Jekk it- tabib tieghek jiddeċiedi li jwaqqaf din il- mediċina, id- doża tista ’ titnaqqaslek bil- mod il- mod fuq perjodu ta ’ ftit ġranet.
109 4.
114 4.
POSSIBLE SIDE EFFECTS
Effetti sekondarji li jista ’ jkollu
Like all medicines, RISPERDAL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra RISPERDAL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very rare:
Rari:
The following side effects may happen:
L- effetti sekondarji li ġejjin jistgħu jseħħu:
Very Common (affects more than 1 user in 10): • Parkinsonism.
Komuni Ħafna (jaffettwaw aktar minn persuna waħda li tużah minn kull 10): • Parkinsoniżmu.
Each individual symptom may occur less frequently than in 1 in 10 people.
Kull sintomu individwali jista ’ jseħħ f’ anqas minn persuna 1 minn kull 10.
Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex) • Headache, difficulty falling or staying asleep.
Parkinsoniżmu jinkludi: żieda fit- tnixxija tal- bżieq jew ħalq dgħumju, ebusija muskolu- skeletrali, tlegħib, ġbid involontarju tal- muskoli meta tgħawweġ l- idejn jew is- saqajn, movimenti tal- ġisem bil- mod, imnaqqsa jew dgħajjfa, l- ebda espressjoni fil- wiċċ, tagħfis fil- muskoli, ebusija fl- għonq, ebusija fil- muskoli, passi żgħar, imkarkrin, bl- għaġġla u nuqqas ta ’ movimenti normali tad- dirgħajn waqt il- mixi, tpetpit ta ’ l - għajnejn persistenti bħala rispons għall- taptip fuq il- ġbin (rifless mhux normali) • Uġigħ ta ’ ras, diffikultà biex torqod jew biex tibqa rieqed/ rieqda.
Common (affects 1 to 10 users in 100): • Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder • Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth • Weight increased, increase in body temperature, decreased appetite • Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred vision, nose congestion, nose bleeding, cough • Urinary tract infection, bed wetting • Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs • Rash, skin redness • Fast beating heart, chest pain • Blood prolactin hormone level increased.
Mhux komuni (jaffettwaw minn 1 sa 10 persuna li tużah minn kull 1, 000): • Xorb eċċessiv ta ’ ilma, inkontinenza ta ’ l- ippurgar, għatx, ippurgar iebes ħafna, ħanqa jew disturb fil- vuċi • Infezzjoni fil- pulmun ikkawżata minn ġbid ta ’ ikel man- nifs għal ġol- passaġġi tan- nifs, infezzjoni fil- bużżieqa ta ’ l- awrina, “ għajn roża ”, infezzjoni tas- sinus, infezzjoni virali, infezzjoni fil- widnejn, infezzjoni fit- tunsilli, infezzjoni taħt il- ġilda, infezzjoni fl- għajnejn, infezzjoni fl- istonku, għajnejn iħammġu, infezzjoni tal- ħmira fid- dwiefer, • Konduzzjoni elettrika tal- qalb mhux normali, pressjoni li tinżel meta toqogħod bil- wieqfa, pressjoni baxxa, tħossok stordut wara li tibdel il- pożizzjoni tal- ġisem, traċċa ta ’ attività elettrika tal- qalb (ECG) mhux normali, ritmu tal- qalb mhux normali, tkun konxju ta ’ qalbek tħabbat, żieda jew tnaqqis fir- rata ta ’ taħbit tal- qalb • Inkontinenza ta ’ l- awrina, uġigħ waqt li tagħmel l- awrina, tagħmel l- awrina aktar frekwenti • Konfuż/ a, disturb fl- attenzjoni, livell baxx ta ’ koxjenza, rqad eċċessiv, nervożiżmu, burdata ta ’ ferħ kbir (manija), nuqqas ta ’ enerġija u interess • Żieda fil- livell ta ’ zokkor fid- demm, żieda fl- enzimi tal- fwied, tnaqqis fl- għadd ta ’ ċelluli bojod, emoglobina baxxa jew għadd ta ’ ċelluli ħomor tad- demm baxxi (anemija), żieda fil - eosinofils (ċelluli bojod tad- demm speċjali), żieda fil- creatinine phosphokinase tad- demm, tnaqqis fil- plejtlits (ċelluli tad- demm li jgħinu l- fsada tieqaf)
Rare (affects 1 to 10 users in 10,000): • Inability to reach orgasm, menstrual disorder • Dandruff • Drug allergy, coldness in arms and legs, lip swelling, lip inflammation • Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling • Lack of emotion • Change in consciousness with increased body temperature and twitching of muscles, edema all over the body, drug withdrawal syndrome, body temperature decreased • Fast shallow breathing, trouble breathing during sleep, chronic otitis media • Obstruction of intestine, • Reduced blood flow to the brain • Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume • Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder • Coma due to uncontrolled diabetes • Yellowing of the skin and the eyes (jaundice) • Inflammation of the pancreas.
Rari (jaffettwaw minn 1 sa 10 persuna li tużah minn kull 10, 000): • Inabbiltà li tilħaq orgażmu, disturb fil- menstrwazzjoni • Brija • Allerġija għall- mediċina, kesħa fid- dirgħajn u s- saqajn, nefħa fix- xufftejn, infjammazzjoni fix - xufftejn • Glawkoma, nuqqas ta ’ ċarezza fil- vista, qoxra niexfa fix- xifer ta ’ tebqet l- għajn, tidwir ta ’ l - għajnejn, • Nuqqas ta ’ emozzjoni • Bidla fil- koxjenza meta togħla t- temperatura tal- ġisem u movimenti involuntarji tal- muskoli, edima madwar il- ġisem kollu, sindrome ta ’ twaqqif tal- mediċina, tnaqqis fit- temperatura tal - ġisem • Teħid tan- nifs qasir u mgħaġġel diffikultà biex tieħu n- nifs waqt l- irqad • Sadd fl- imsaren • Tnaqqis ta ’ demm li jmur lejn il- moħħ • Tnaqqis fiċ- ċelluli bojod tad- demm, tnixxija mhux adattata ta ’ l- ormon li jikkontrolla l- volum ta ’ l- awrina • Ħsara fil- fibra tal- muskolu u uġigħ fil- muskoli (rabdomijaliżi), disturb fil- moviment, • Koma minħabba dijabete mhux ikkontrollata • Ġilda tisfar u l- abjad ta ’ l- għajnejn jisfar (suffejra) • Infjammazzjoni tal- frixa
Very rare (affects less than 1 user in 10,000): • Life threatening complications of uncontrolled diabetes.
Rari ħafna (jaffettwaw anqas minn persuna waħda li tużah minn kull 10, 000): • kumplikazzjonijiet ta ’ dijabete mhux kontrollata li huma ta ’ periklu għall- ħajja
111 Unknown frequency of occurrence (frequency cannot be estimated from the available data): • Severe allergic reaction resulting in difficulty in breathing and shock • No granulocytes (a type of white blood cell to help you against infection) • Prolonged and painful erection • Dangerously excessive intake of water.
Mhix magħrufa l- frekwenza li biha jseħħu (ma tistax tittieħed stima mid- data disponibbli): • Reazzjoni allerġika qawwija li twassal għal diffiklutà fit- teħid tan- nifs u xokk • Ma jkunx hemm granuloċiti (tip ta ’ ċellula bajda tad- demm li tgħinek kontra infezzjoni) • Erezzjoni li ddum u tkun bl- uġigħ • Tixrob ammont eċċessiv u perikoluż ta ’ ilma.
RISPERDAL CONSTA The following side effects have been reported with the use of RISPERDAL CONSTA, a long acting injection.
116 RISPERDAL CONSTA L- effetti sekondarji li ġejjin kienu rrappurtati bl- użu ta ’ RISPERDAL CONSTA, injezzjoni li taħdem fit- tul.
Even if you are not being treated with long acting injections of RISPERDAL CONSTA but you experience any of the following, talk to your doctor.
Anke jekk inti m’ intix qed tiġi kkurat b’ injezzjonijiet ta ’ RISPERDAL CONSTA li jaħdmu fit - tul iżda jkollok xi waħda minn dawn li ġejjin, kellem lit- tabib tiegħek.
• Infection of the intestine • Abscess under the skin, tingling pricking or numbness of skin, inflammation of the skin • Decrease in white blood cell counts that helps to protect you against bacterial infection • Depression • Convulsion • Eye blinking • Sensation of spinning or swaying • Slow beating heart, high blood pressure • Toothache, tongue spasm • Buttock pain • Weight decreased.
• Infezzjoni ta ’ l- intestina • Axxess taħt il- ġilda, tnemnim, tingiż jew titrix fil- ġilda, infjammazzjoni tal- ġilda • Tnaqqis fl- għadd taċ- ċelloli bojod li jgħinu biex jipproteġuk kontra infezzjoni mill- batterji • Depressjoni • Aċċessjoni • Teptip ta ’ l- għajnejn • Sensazzjoni li kollox qed idur jew jitbandal • Qalb tħabbat bil- mod, pressjoni għolja • Uġigħ tas- snien, spażmu fl- ilsien • Uġigħ fil- warrani • Tnaqqis fil- piż
HOW TO STORE RISPERDAL
Kif taħżen RISPERDAL
[To be completed nationally] Keep out of the reach and sight of children.
[Biex timtela mill- pajjiż partikolari.] Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use after the expiry date which is stated on the blister, foil, carton, or bottle.
Tużahx wara d- data ta ’ skadenza li tidher fuq il- folja, fojl, kartuna jew flixkun.
RISPERDAL Quicklet orodispersible tablets
Pilloli RISPERDAL Quicklet li jinħallu fil- ħalq
RISPERDAL oral solution
RISPERDAL Soluzzjoni orali
FURTHER INFORMATION
Aktar tagħrif
What RISPERDAL contains
X’ fih RISPERDAL
The active substance is risperidone
Is- sustanza attiva hi risperidone
Each RISPERDAL film-coated tablet contains either 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 6 mg of risperidone.
Kull pillola RISPERDAL miksija b’ rita fiha jew 0. 25 mg, 0. 5 mg, 1 mg, 2 mg, 3 mg, 4 mg jew 6 mg ta ’ risperidone.
112 What RISPERDAL looks like and contents of the pack
Id- Dehra ta ’ RISPERDAL u l- kontenuti tal- pakkett
RISPERDAL film-coated Tablets
Pilloli RISPERDAL miksijin b’ rita
RISPERDAL Quicklet orodispersible tablets
117 Pilloli Quicklet li jinħallu fil- ħalq
Belgium:
Risperdal ® / Rispolin ® / Risperdal® Quicklet® / Rispolin® Quicklet® L- Awstrija:
Risperdal ®/ Rispolin ®/ Risperdal® Quicklet® / Rispolin® Quicklet® RISPERDAL® / Risperidone J-C ® / RISPERDAL Instasolv ® / Risperidone J-C Instasolv ®
RISPERDAL® / Risperidone J- C ® / RISPERDAL Instasolv ® / Il- Belġju:
Bulgaria:
Risperidone J- C Instasolv ® РИСПОЛЕПТ® Il- Bulgarija:
Cyprus:
RISPERDAL® Ċipru:
Denmark:
RISPERDAL® RISPERDAL® Id- Danimarka:
Estonia:
RISPOLEPT® / RISPOLEPT® QUICKLET® L- Estonja:
Finland:
RISPERDAL® / RISPERDAL® INSTASOLV® Il- Finlandja:
France:
RISPERDAL® / BELIVON® / RISPERDALORO® Franza:
Latvia:
Latvja:
РИСПОЛЕПТ ® RISPERDAL® RISPERDAL® RISPERDAL® RISPOLEPT® / RISPOLEPT® QUICKLET® RISPERDAL® / RISPERDAL® INSTASOLV® RISPERDAL®/ BELIVON® / RISPERDALORO® Belivon / Rehablit / RISPERDAL / RISPERDAL QUICKLET / Risperidon-Janssen RISPERDAL® / RISPERDAL® QUICKLET RISPERDAL RISPERDAL® RISPERDAL® / RISPERDAL® Quicklet® RISPERDAL®/ BELIVON® / ACTASE® RISPOLEPT® / RISPOLEPT® Quicklet® RISPOLEPT® / RISPERDAL® Quicklet® RISPERDAL® / RISPERDAL® QUICKLET® RISPERDAL® / Risperidone J-C ® RISPERDAL Instasolv ® / Risperidone J-C Instasolv ®
RISPERDAL RISPERDAL® RISPERDAL® / RISPERDAL® Quicklet® RISPERDAL® / BELIVON® / ACTASE® RISPOLEPT® / RISPOLEPT® Quicklet® RISPOLEPT® / RISPERDAL® Quicklet® RISPERDAL® / RISPERDAL® QUICKLET®
Netherlands:
RISPERDAL® / BELIVON® / RISPERDAL Quicklet ® L- Olanda:
Norway:
RISPERDAL® / RISPERDAL®smeltetabletter In- Norveġja:
Poland:
RISPOLEPT® / RISPOLEPT® QUICKLET Il- Polonja:
Portugal:
RISPERDAL® / RISPERDAL® QUICKLET® Il- Portugall:
Romania:
RISPOLEPT® / RISPOLEPT QUICKLET Ir- Rumanija:
Slovenia:
RISPERDAL® / RISPERDAL® QUICKLET® Is- Slovakkja:
RISPERDAL® RISPERDAL®/ BELIVON® / RISPERDAL Quicklet ® RISPERDAL® / RISPERDAL®smeltetabletter RISPOLEPT® / RISPOLEPT® QUICKLET RISPERDAL® / RISPERDAL® QUICKLET® RISPOLEPT® / RISPOLEPT QUICKLET RISPERDAL® / RISPERDAL® QUICKLET® RISPERDAL® / RISPERDAL QUICKLET®
RISPERDAL® / RISPERDAL QUICKLET® Slovenja:
Sweden:
RISPERDAL® / RISPERDAL® FLAS Spanja:
United Kingdom:
RISPERDAL® / BELIVON® L- Isvezja:
RISPERDAL® / RISPERDAL® FLAS RISPERDAL®/ BELIVON® RISPERDAL®/ RISPERDAL® Quicklet®
RISPERDAL® / RISPERDAL® Quicklet® Ir- Renju Unit:
This leaflet was last approved in {MM/ YYYY}.
118 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
114 ANNEX IV
119 ANNESS IV
CONDITIONS OF THE MARKETING AUTHORISATIONS
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONIJIET GĦAT- TQEGĦID FIS- SUQ
115 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
120 L- Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill- Istat Membru ta ’ Referenza, għandhom jassiguraw li l- kundizzjonijiet li ġejjin jiġu osservati mid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
The Marketing Authorisation Holder commits to generate a collection of long-term data for the evaluation of long-term safety of risperidone in children and adolescents with conduct disorder in terms of potential effects on growth (height and weight), mental development, and sexual maturation (by Tanner stage).
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jipproduċi ġabra ta ’ informazzjoni fuq perjodu fit- tul għall- evalwazzjoni tas- sigurtà ta ’ risperidone fuq perjodu fit- tul fi tfal u adolexxenti b’ disturb tal- imġiba għal dak li għandu x’ jaqsam mal- effetti potenzjali fuq it- tkabbir (tul u piż), l- iżvilupp mentali, u l- maturazzjoni sesswali (skont l- istadju Tanner).
Regarding cognitive assessment, the MAH should make a proposal as to how it would be possible to assess effects on cognitive development.
Dwar l - evalwazzjoni konoxxittiva, l- MAH għandu jagħmel proposta dwar kif ikunu jistgħu jiġu evalwati l - effetti fuq l- iżvilupp konoxxittiv.
116
121
EMEA/ CHMP/ 384877/ 2008
EMEA/ CHMP/ 556344/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal and associated names
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 30 GĦAL Risperdal u ismijiet assoċjati
Risperdal and associated names is as an antipsychotic, indicated for the treatment of schizophrenia, manic episodes associated with bipolar disorders, persistent aggression in patients with moderate to severe Alzheimer’ s dementia and treatment of persistent aggression in conduct disorder in children.
Risperdal u ismijiet assoċjati huwa antipsikotiku, indikat għat- trattament tal- iskizofrenija, episodji manijaċi assoċjati ma ’ disturbi bipolari, aggressjoni persistenti f’ pazjenti b’ dimenzja tal- Alzheimer moderata sa severa u trattament ta ’ aggressjoni persistenti f’ disturbi fl- imġiba tat- tfal.
It is available as film coated tablets, oro-dispersible tablets (rapidly disintegrating) and oral solution.
Jiġi bħala pilloli miksijin b’ rita, pilloli li jinħallu fil- ħalq (li jiddisintegraw malajr) u bħala soluzzjoni orali.
On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal and associated names.
Fl- 24 ta ’ Lulju 2007, il- Kummissjoni Ewropea ippreżentat lill- EMEA riferment skont l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendata, sabiex jiġu armonizzati s- Sommarji tal- Karatteristiċi tal - Prodott (SPC), it- Tikketta u l- Fuljett ta ’ Tagħrif awtorizzati fuq livell nazzjonali, tal- prodott mediċinali Risperdal u ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal and associated names approved across EU Member States, with respect to the indications, the posology and method of administration, the contra-indications, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Il- bażi għar- riferiment kien li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Risperdal u ismijiet assoċjati approvati madwar l- Istati Membri tal- UE, fir- rigward tal - indikazzjonijiet, il- pożoloġija u l- metodu ta ’ għoti, il- kontraindikazzjonijiet, it- twissijiet speċjali u l - prekawzjonijiet għall- użu u l- interazzjoni ma ’ prodotti mediċinali oħrajn u ma ’ forom ta ’ interazzjoni oħrajn.
This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Dan il- prodott mediċinali jappartjeni għal- lista ta ’ prodotti identifikati fl- 2007 għall- armonizzazzjoni tal- SPC.
During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Matul il- laqgħa tiegħu ta ’ Lulju 2008, is- CHMP, fid- dawl tad- dejta ġenerali ppreżentata u tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, Tikketta u Fuljett ta ’ Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal and associated names.
Is- CHMP ta opinjoni pożittiva fl- 24 ta ’ Lulju 2008 u rrakkomanda l- armonizzazzjoni tal- SPC, it - Tikketta u l- Fuljett ta ’ Tagħrif għal Risperdal u l- ismijiet assoċjati.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
LISTA TA ’ L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, IL- QAWWA TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L- APPLIKANTI FL- ISTATI MEMBRI
1 Member State EU/ EEA
1 Stat Membru
(Invented) Name
Isem Ivvintat Isem
Pressurised
Il- Belġju
25 83607 Holzkirchen Germany
25, 83607 Holzkirchen Il- Ġermanja
100 μ g/ dose
Salbutamol Sandoz 100 µg/ doża 100µg Aërosol, suspensie
inhalation, suspension
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs nifs, suspensjoni
Inhalation use
Id- Danimarka
100 μ g/ dose
Salbutamol Sandoz 100 µg/ doża
Pressurised
L- Estonja
100 mikrogrammi/ annuses
Salbutamol Sandoz 100 µg/ doża 100 mikrogrammi/ annus es
Inhalation use
Il- Finlandja
Inhalation use
Il- Ġermanja
25 83607 Holzkirchen
25, 83607 Holzkirchen Il- Ġermanja
100 mikrogramm Dosieraerosol
Salbutamol Sandoz 100 µg/ doża 100 mikrogramm Dosieraerosol Druckgasinhalation, Suspension
Inhalation use
Il- Greċja
Germany
HEXAL AG, Industriestr.
Druckgas-inhalation, Suspension
25, 83607 Holzkirchen Il- Ġermanja
100 μ g/ dose
Salbutamol/ Sandoz 100 µg/ doża
Pressurised
L- Ungerija
100 µg túlnyomásos inhalációs szuszpenzió
Salbutamol Sandoz 100 µg/ doża 100 µg túlnyomásos inhalációs szuszpenzió
100 μ g/ dose
Salbutamolo Sandoz 100 µg/ doża 100 mcg
inhalation, suspension
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs
Hexal AG
L- Italja
Salbutamol Sandoz
83607 Holzkirchen Il- Ġermanja
Latvia
nifs, suspensjoni
100 μ g/ dose
Salbutamol Sandoz 100 µg/ doża 100
Inhalation use
Il- Latvja
Hexal AG
83607 Holzkirchen Il- Ġermanja
Pressurised
nifs, suspensjoni
100 μ g/ dose
Solbutamol Sandoz 100 µg/ doża 100 mikrogramu dozeje suslegta
25
25, 83607 Holzkirchen
aërosol 100 µg/ dosis,
Salbutamol Sandoz 100 µg/ doża aërosol 100 µg/ dosis, aërosol,
inhalation,
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs nifs, suspensjoni
aërosol, suspensie 100 microgram per dosis
suspensie 100 microgram per dosis
Pressurised
In- Norveġja
100 μ g/ dose
100 µg/ doża
Inhalation use
83607 Holzkirchen Il- Ġermanja
SalbuLEK
nifs, suspensjoni
Pressurised
Il- Polonja
Portugal
SalbuLEK
Salbutamol Lek 100
nifs, suspensjoni
Pressurised
Il- Portugall
mikrogramov
Salbutamol Sandoz
inhalation,
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs
Strength
25,
Pharmaceutical Form
Salbutamol Lek 100 100 µg/ doża mikrogramov
Route of administration
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs
83607 Holzkirchen Germany
83607 Holzkirchen Il- Ġermanja
inhalacijska suspenzija pod tlakom
inhalacijska suspenzija pod tlakom
suspension
nifs, suspensjoni
100 mcg/ dosis suspensión para inhalación en envase a presción EFG
Salbutamol Sandoz 100 µg/ doża 100 mcg/ dosis
Inhalation use
Spanja
Salbutamol 100
Sabumalin 100 µg/ doża
Pressurised
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs nifs, suspensjoni
Woolmer Way Bordon Hants GU35 9QE United Kingdom
25, 83607 Holzkirchen
microgram per actuation pressurised inhalation, suspension
Salbutamol 100 100 µg/ doża microgram per actuation
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SABUMALIN AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ SABUMALIN U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Sabumalin is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/ spray, with HFA 134a as propellant.
Sabumalin huwa inalatur aerosol ta ’ doża mkejla li fih formulazzjoni ta ’ sospensjoni ta ’ salbutamol sulfat 100 µg/ sprej, b’ HFA 134a bħala propellent.
The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/ 83/ EC and the EU reference product is Sultanol Dosier-Aerosol 100 μ g/ dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
L- applikazzjonijiet għat- tqegħid fis- suq ġew ippreżentati bħala applikazzjonijiet ibridi skont l- Artikolu 10( 3) tad- Direttiva 2001/ 83/ KE u l- prodott ta ’ referenza tal- UE huwa Sultanol Dosier- Aerosol 100 μg/ doża, Druckgasinhalation, sospensjoni, (GlaxoSmithKline).
The reference product in SE is Ventoline Evohaler, 0.1 mg/ dose (GlaxoSmithKline AB).
Il- prodott ta ’ referenza fl- SE huwa Ventoline Evohaler, 0. 1 mg/ doża (GlaxoSmithKline AB).