qanastek/EMEA-V3 huggingface dataset:
Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
Qiegħed il- labra b’ mod sod fl- apparat Needle- Pro b’ imbuttatura u tidwira lejn in - naħa tal- lemin.
Prepare the patient for injection.
Folja forma ta ’ borża
RESUSPENSION OF RISPERDAL CONSTA WILL BE NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
IS- SUSPENSJONI MILL- ĠDID TA ’ RISPERDAL CONSTA TINĦTIEĠ QABEL MA ’ DAN JINGĦATA MINĦABBA LI T- TRAB JINŻEL FIL- QΙEGĦ MAL- ĦIN LADARBA L- PRODOTT JIĠI RIKOSTITWIT.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
FERREX IL- MIKROSFERI MILL - ĠDID FIS- SUSPENSJONI ĠOS- SIRINGA BILLI TĦAWWAD BIS- SAĦĦA.
Pull sheath away from the needle – do not twist sheath as needle may be loosened from Needle- Pro device.
Iġbed l- għant minn madwar il- labra – iddawwarx l- għant minħabba l- labra tista ’ tinħall minn ma l- apparat Needle- Pro.
Tap the syringe gently to make any air bubbles rise to the top.
Taptap is- siringa b’ mod delikat biex iġġiegħel il- bżieżaq ta ’ l- arja jitilgħu fil- wiċċ.
Remove air bubbles from the syringe barrel by moving the plunger rod forward with the needle in an upright position.
Neħħi l- bżieżaq ta ’ l- arja mill- parti ċilindrika tas- siringa billi timbotta l- planġer il- ġewwa bil - labra miżmuma f’ pożizzjoni dritta.
Inject the entire contents of the syringe intramuscularly into the buttock of the patient.
Injetta il- kontenut kollu tas- siringa ġol- muskolu tal- warrani tal- pazjent.
DO NOT ADMINISTER INTRAVENOUSLY.
39 Apparat ta ’ protezzjoni għall - labra
To avoid a needle stick injury with a contaminated needle, do not: • Intentionally disengage the Needle-Pro device • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged • Mishandle the needle protection device that could lead to protrusion of the needle from it 38 12.
Biex tevita li titniggeż bil- labra kkontaminata, tippruvax: • Taqla intenzjonalment l- apparat Needle- Pro • Tipprova tiddritta l- labra jew twaħħal l- apparat Needle- Pro jekk il- labra hija mgħawwġa jew mhix tajba • Taqbad l- apparat ta ’ protezzjoni tal- labra b’ mod goff li jista ’ jwassal biex il- labra toħroġ minnu
After procedure is completed, press the needle into the needle protection device.
Wara li l- proċedura titlesta, agħfas il- labra ġo l- apparat ta ’ protezzjoni għall- labra.
Perform a one- handed technique by GENTLY pressing the needle protection device against a flat surface.
Agħmel dan b’ id waħda billi BIL- ĦLEWWA tagħfas l- apparat ta ’ protezzjoni tal- labra ma ’ superfiċje ċatt.
As the needle protection device is pressed, the needle is firmly engaged into it.
Kif l- apparat ta ’ protezzjoni tal- labra jingħafas, il- labra tidħol b’ mod sod fih.
Visually confirm that the needle is fully engaged into the needle protection device.
Ikkonferma viżwalment li l- labra daħlet sewwa fl- apparat ta ’ protezzjoni tal- labra.
Immediately discard appropriately.
Armi b’ mod xieraq immedjatament.
Instructions for Needle-Free Vial Access Device
Struzzjonijiet għall- Apparat ta ’ Aċċess għall- Kunjett Mingħajr Labra
RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringe supplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Mikrosferi RISPERDAL CONSTA li jintreħew bil- mod, li qegħdin fil- kunjett, għandhom jiġu rikostitwiti biss fis- solvent ta ’ ġos- siringa pprovduta fil- pakkett tad- doża, u għandu jingħata biss bil - labra ta ’ sigurtà Needle- Pro pprovduta fil- pakkett tad- doża.
To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered.
Biex tiżgura li d- doża intenzjonata ta ’ risperidone ingħatat kollha, għandu jingħata l - kontenut sħiħ tal- kunjett.
• One vial containing RISPERDAL CONSTA extended release microspheres • One Alaris SmartSite needle-free vial access device for reconstitution • One prefilled syringe containing the solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle-with needle protection device)
• Kunjett wieħed li fih mikrosferi ta ’ RISPERDAL CONSTA li jintreħew bil- mod • Apparat wieħed ta ’ Aċċess għall- Kunjett Mingħajr Labra Alaris SmartSite għar- rikostituzzjoni • Siringa waħda mimlija għal- lest li fiha s- solvent għal RISPERDAL CONSTA • Labra waħda Needle- Pro għall- injezzjoni ġol- muskolu (labra ta ’ sigurtà 20G 2 "TW b’ apparat ta ’ protezzjoni għal- labra)
Flip off the plastic coloured cap from the vial.
Aqla l- għatu tal- plastik ikkulurit mill- kunjett.
Peel back the blister pouch and remove the vial access device by holding the white luer cap.
Qaxxar il- folja forma ta ’ borża u neħħi l- apparat ta ’ aċċess għall- kunjett billi żżomm it- tapp luer abjad.
Do not touch the spike tip of the access device at any time.
Qatt tmiss il- ponta tal- metall ta ’ l- apparat ta ’ aċċess.
Place vial on a hard surface.
Poġġi l- kunjett fuq superfiċje iebes.
With a straight push down movement press the spike tip of the vial access device through the centre of the vial’ s rubber stopper until the device securely snaps onto the vial top.
B’ imbottatura dritta l- isfel agħfas il- ponta tal- metall ta ’ l - apparat ta ’ aċċess għall- kunjett, biex tinfed iċ- ċentru tat- tapp tal- gomma tal- kunjett sakemm l - apparat jaqbad b’ mod sod mal- parti ta’ fuq tal- kunjett.
Swab the connection point of the vial access device with preferred antiseptic prior to attaching the syringe to the vial access device.
Imsaħ il- punt ta ’ konnessjoni ta ’ l- apparat ta ’ aċċess għall- kunjett b’ antisettiku li tippreferi qabel ma ’ twaħħal is- siringa ma ’ l- apparat ta ’ aċċess għall- kunjett.
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside.
Iftaħ is- siringa mimlja għal- lest billi tkisser is- siġill li hi magħluqa bih u neħħi t- tapp abjad flimkien mat- tapp bit- tarf tal- gomma li hemm fih..
Press the syringe tip into the vial access device and twist in a clockwise motion to ensure that the syringe is securely attached to the white luer cap of the vial access device.
Agħfas il- ponta tas- siringa ġo l- apparat ta ’ aċċess għall- kunjett u dawwar b’ ċaqliqa lejn il- lemin biex tiżgura l- s- siringa weħlet b’ mod sod mat- tapp abjad luer ta ’ l- apparat ta ’ aċċess għall - kunjett.
Hold the skirt of the vial access device during attachment to prevent spinning.
Żomm il- għata ta ’ l- apparat ta ’ aċċess għall- kunjett waqt li tkun qed twaħħlu biex tevita li jdur fuqu nnifsu.
Keep the syringe and the vial access device aligned.
Żomm is- siringa u l- apparat ta ’ aċċess għall- kunjett bi dritt xulxin.
Inject the entire contents (solvent) of the syringe into the vial.
Injetta l- kontenut kollu (solvent) tas- siringa ġol- kunjett.
Holding the plunger rod down with the thumb, shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Filwaqt li żżomm il- panġer l- isfel b’ sebgħek il- kbir, ħawwad il- kunjett bis- saħħa għal mill - anqas 10 sekondi sakemm tikseb suspensjoni omoġena.
Mixing is complete when the suspension appears uniform, thick, and milky in colour and all the powder is fully dispersed.
It- taħlit ikun komplut meta s- suspensjoni tidher uniformi, magħquda u kulur il- ħalib u t- trab kollu jkun xtered kompletament fit- taħlita.
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
TAĦŻINX IL- KUNJETT WARA R- RIKOSTITUZZJONI GĦAX INKELLA S - SUSPENSJONI TISTA ’ TISSEPARA U T- TRAB JINŻEL FIL- QIEGĦ.
Invert the vial completely and slowly withdraw the entire contents of the suspension from the vial.
Aqleb il- kunjett rasu l- isfel u bil- mod il- mod iġbed il- kontenut kollu tas- suspensjoni mill - kunjett.
Unscrew the syringe from the vial access device.
Ħoll is- siringa minn ma ’ l- apparat ta ’ aċċess għall- kunjett.
Discard the vial and the vial access device appropriately.
Armi l- kunjett u l- apparat ta ’ aċċess għall- kunjett kif xieraq.
Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
Qiegħed il- labra b’ mod sod fuq l- apparat Needle- Pro b’ imbuttatura u tidwira lejn in- naħa tal- lemin.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY SHAKING VIGOROUSLY.
FERREX IL- MIKROSFERI MILL - 44 ĠDID FIS- SUSPENSJONI ĠOS- SIRINGA BILLI TĦAWWAD BIS- SAĦĦA.
Pull sheath away from the needle – do not twist sheath as needle may be loosened from Needle- Pro device.
Iġbed l- għant minn madwar il- labra – iddawwarx l- għant minħabba li l- labra tista ’ tinħall minn ma ’ l- apparat Needle- Pro.
Inject the entire contents of the syringe intramuscularly into the buttock of the patient.
Injetta l- kontenut kollu tas- siringa ġol- muskolu tal- warrani tal- pazjent.
DO NOT ADMINISTER INTRAVENOUSLY.
Apparat ta ’ protezzjoni għall- labra
43 WARNING:
TWISSIJA:
To avoid a needle stick injury with a contaminated needle, do not: • Intentionally disengage the Needle-Pro device • Attempt to straighten the needle or engage the Needle-Pro device if the needle is bent or damaged • Mishandle the needle protection device that could lead to protrusion of the needle from it
Biex tevita li titniggeż bil- labra kkontaminata, tippruvax: • Taqla intenzjonalment l- apparat Needle- Pro • Tipprova tiddritta l- labra jew twaħħal l- apparat Needle- Pro jekk il- labra hija mgħawwġa jew mhix tajba • Taqbad l- apparat ta ’ protezzjoni tal- labra b’ mod goff li jista ’ jwassal biex il- labra toħroġ minnu
After procedure is completed, press the needle into the needle protection device.
Wara li l- proċedura titlesta, agħfas il- labra ġo l- apparat ta ’ protezzjoni.
Visually confirm that the needle is fully engaged into the needle protection device.
Ikkonferma viżwalment li l - labra daħlet sewwa fl- apparat ta ’ protezzjoni tal- labra.
[See Annex I – To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari.]
{Name and address}
{Isem u indirizz}
44 LABELLING
46 TIKKETTA
Outer Carton (Pack with ALARIS)
Kartuna ta ’ Barra (Pakkett b’ ALARIS)
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally]
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 12. 5 mg ta ’ trab u solvent għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu [Ara Anness I - Biex timtela mill- pajjiż partikolari.]
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 25 mg ta ’ trab u solvent għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 37. 5 mg ta ’ trab u solvent għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 50 mg ta ’ trab u solvent għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu
Powder and solvent for prolonged-release suspension for injection.
Trab u Solvent għal suspensjoni li jintreħa bil- mod għall- injezzjoni.
For intramuscular use only.
Għal użu ġol- muskolu biss.
[See Annex I - To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari.]
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer Carton (Pack with 3 needle system)
Kartuna ta ’ Barra (Pakkett b’ sistema ta ’ 3 labriet)
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally]
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 12. 5 mg ta ’ trab u solvent għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Powder and solvent for prolonged-release suspension for injection.
Trab u solvent għal suspensjoni li jintreħa bil- mod għall- injezzjoni.
Outer Carton (Pack with ALARIS and separate storage for solvent)
Kartuna ta ’ Barra (Pakkett b’ ALARIS u ħażna separata għas- solvent)
Powder and solvent for prolonged-release suspension for injection.
Trab li u solvent għal suspensjoni jintreħa bil- mod għall- injezzjoni.
Vial for powder for suspension for injection (all packs)
Kunjett għat- trab għal suspensjoni għall- injezzjoni (il- pakketti kollha)
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally]
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 12. 5 mg ta ’ trab għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu [Biex timtela mill- pajjiż partikolari.]
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 25 mg ta ’ trab għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 37. 5 mg ta ’ trab għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 50 mg ta ’ trab għal suspensjoni li tintreħa bil- mod għal injezzjoni għal ġol- muskolu
52 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
54 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Pre filled Syringe (all packs)
Siringa mimlija għal- lest (il- pakketti kollha)
Solvent for RISPERDAL CONSTA 12.5 mg/ 25 mg/ 37.5 mg/ 50 mg and associated names (see Annex I) [See Annex I – To be completed nationally]
Solvent għal RISPERDAL CONSTA 12. 5 mg/ 25 mg/ 37. 5 mg/ 50 mg u ismijiet assoċjati miegħu (ara Anness I)
Keep prefilled syringe in the outer carton
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra
53 PACKAGE LEAFLET
55 FULJETT TA ’ TAGĦRIF
54 PACKAGE LEAFLET:
56 FULJETT TA ’ TAGĦRIF:
RISPERDAL CONSTA and associated names (see Annex I) 12.5, 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally] Risperidone
RISPERDAL CONSTA 12. 5, 25, 37. 5 u 50 mg trab u solvent li jerħu il- mediċina bil- mod għal suspenzjoni għall- injezzjoni ġol- muskolu [Ara Anness I – Biex timtela mill- pajjiż partikolari] Risperidone
Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
What RISPERDAL CONSTA is and what it is used for 2.
X’ inhu RISPERDAL CONSTA u għalxiex jintuża 2.
Before you use RISPERDAL CONSTA 3.
Qabel ma tuża RISPERDAL CONSTA 3.
How to use RISPERDAL CONSTA 4.
Kif għandek tuża RISPERDAL CONSTA 4.
How to store RISPERDAL CONSTA 6.
Kif taħżen RISPERDAL CONSTA 6.
WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR
X’ INHU RISPERDAL CONSTA U GĦALXIEX JINTUŻA
RISPERDAL CONSTA belongs to a group of medicines called ‘ anti-psychotics’.
RISPERDAL CONSTA tagħmel parti minn grupp ta ’ mediċini imsejħa ‘ anti- psikotiċi ’.
RISPERDAL CONSTA is used to maintain the treatment of 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
RISPERDAL CONSTA jintuża biex tmantni l- kura ta ’ skizofrenja, fejn inti tista ’ tara, tisma ’ jew tħoss affarijiet li m’ humiex hemm, temmen affarijiet li m ’ humiex veri jew tħossok suspettuż/ a b’ mod mhux tas- soltu, jew konfuż/ a.
RISPERDAL CONSTA is intended for patients who are currently treated with oral (e. g. tablets, capsules) antipsychotics.
RISPERDL CONSTA huwa maħsub għall- pazjenti li bħalissa qed jiġu kkurati b’ antipsikotiċi mill - ħalq (eż. pilloli, kapsuli).
BEFORE YOU USE RISPERDAL CONSTA
QABEL MA TUŻA RISPERDAL CONSTA
Do not take RISPERDAL CONSTA • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of RISPERDAL CONSTA (listed in Section 6 below).
Tieħux RISPERDAL CONSTA: • Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva għal risperidone jew għal xi wieħed mis- sustanzi l- oħra ta ’ RISPERDAL CONSTA (elenkati f’ Sezzjoni 6 hawn taħt).
Take special care with RISPERDAL CONSTA • If you have never taken any form of RISPERDAL, you should begin with oral RISPERDAL before beginning treatment with RISPERDAL CONSTA.
Oqogħod attent ħafna b ’ RISPERDAL CONSTA • Jekk inti qatt ma ħadt l- ebda forma ta ’ RISPERDAL, inti għandek tibda b’ RISPERDAL li jittieħed mill- ħalq qabel tibda kura b ’ RISPERDAL CONSTA.
Check with your doctor or pharmacist before using RISPERDAL CONSTA if:
Iċċekkja mat- tabib jew l- ispiżjar tiegħek qabel tuża RISPERDAL CONSTA jekk:
• You have a heart problem.
57 • Inti għandek problema f’ qalbek.
RISPERDAL CONSTA may cause low 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 CONSTA 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 circulation disorders of the brain • You have Parkinson’ s disease or dementia • You are diabetic • You have epilepsy
Id- doża tiegħek jista ’ jkolla bżonn tiġi aġġustata • Inti taf b’ xi ċirkustanzi li jistgħu jgħinu biex inti jkollok puplesija, bħal pressjoni għolja, disturb kardjovaskulari jew disturbi ta ’ ċirkulazzjoni fil- moħħ • Inti għandek il- marda ta ’ Parkinson jew dimenzja • Inti dijabetiku/ a • Inti għandek l- epilessija • Inti raġel u inti qatt kellek erezzjoni fit- tul jew li tweġġgħek.
If you experience this while taking RISPERDAL CONSTA, contact your doctor straight away • You have difficulty controlling 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 CONSTA, 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
Għid lit- tabib tiegħek mill- ewwel jekk ikollok
• involuntary rhythmic movements of the tongue, mouth and face.
• movimenti involuntarji ritmiċi ta ’ l- ilsien, tal- ħalq u tal- wiċċ.
Withdrawal of risperidone may be needed • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “ neuroleptic malignant syndrome).
It- twaqqif ta ’ risperidone jista ’ jkun meħtieġ • deni, ebusija qawwija fil- muskoli, għaraq jew livell imnaqqas ta ’ koxjenza (disturb imsejjaħ “ sindrome newrolettiku malinn ”).
Immediate medical treatment may be needed.
Kura medika immedjata tista ’ tkun meħtieġa.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL or RISPERDAL CONSTA.
Jekk m’ intix ċert/ a jekk xi waħda minn dawn tapplikax għalik, tkellem mat- tabib jew l- ispiżjar tiegħek qabel tuża RISPERDAL jew RISPERDAL CONSTA.
RISPERDAL CONSTA may cause you to gain weight.
RISPERDAL CONSTA jista ’ jġagħlek iżżid fil- piż.
Elderly people with dementia RISPERDAL CONSTA is not for use in elderly people with dementia.
Persuni anzjani bid- dimenzja RISPERDAL CONSTA mhux qiegħed għall- użu f’ persuni anzjani bid- dimenzja.
Medical treatment should be sought straight away if you or your carer 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 ’ jiftiehemx, anke għal perjodu qasir ta ’ żmien.
These may be signs of a stroke.
Dawn jistgħu jkunu sinjali ta ’ puplesija.
Using other medicines Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription and herbal medicines.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tuża jew użajt 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 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 for Parkinson's disease (such as levodopa) • 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 tal- qalb tiegħek, bħal mediċini għall- malarja, tal- problemi fir- ritmu tal- qalb (bħal quinidine), ta ’ l- allerġiji (anti- istaminiċi) xi antidepressanti u mediċini oħra għall- problemi mentali • Mediċini li jikkawżaw taħbit bil- mod tal- qalb • Mediċini li jikkawżaw potassium baxx fid- demm (eż. ċerti dijuretiċi) • Mediċini għall- marda ta ’ Parkinson (bħal levodopa) • Mediċini li jikkuraw pressjoni għolja.
RISPERDAL CONSTA can lower blood pressure • 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 CONSTA jista ’ jbaxxi l- pressjoni • 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 CONSTA taken by itself or with furosemide, may have an increased risk of stroke or death in elderly people with dementia.
RISPERDAL CONSTA meta
The following medicines may reduce the effect of risperidone • Rifampicin (a medicine for treating some infections) • Carbamazepine, phenytoin (mdicines for epilepsy) • Phenobarbital If you start or stop taking such medicines you may need a different dose of risperidone
58 jittieħed waħdu jew ma ’ furosemide, jista ’ joħloq riskju ogħla ta ’ puplesija jew mewt f’ persuni anzjani bid- dimenzja.
The following medicines may increase the effect of risperidone • Quinidine (used for certain types of heart disease)
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
56 • 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) • Cimetidie, 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 CONSTA.
Jekk m’ intix ċert jekk xi waħda minn dawn t’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill - ispiżjar tiegħek qabel tuża RISPERDAL CONSTA.
Using RISPERDAL CONSTA with food and drink You should avoid drinking alcohol when using RISPERDAL CONSTA.
Meta tuża RISPERDAL ma ’ l- ikel u max- xorb Għandek tevita li tixrob l- alkoħol meta tuża RISPERDAL CONSTA.
Pregnancy and breast-feeding • Talk to your doctor before using RISPERDAL CONSTA if you are pregnant, trying to become pregnant or breast-feeding.
Tqala u treddigħ • Kellem lit- tabib tiegħek qabel tuża RISPERDAL CONSTA jekk inti tqila, qed tipprova toħroġ tqila jew qed tredda ’.
Your doctor will decide if you can use 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 tużaha • 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Staqsi lill- ispiżjar jew lit- tabib tiegħek għall- parir qabel tieħu xi mediċina.
Driving and using machines Dizziness, tiredness, and vision problems may occur during treatment with RISPERDAL CONSTA.
Sewqan u tħaddim ta ’ magni Sturdament, għejja, u problemi bil- vista jistgħu jseħħu waqt kura b’ RISPERDAL CONSTA.
Do not drive or use any tools or machines without talking to your doctor first.
Issuqx jew tħaddem għodod jew magni mingħajr ma ’ l- ewwel tkellem lit- tabib tiegħek.
HOW TO USE RISPERDAL CONSTA
KIF TUŻA RISPERDAL CONSTA
RISPERDAL CONSTA is given as an intramuscular injection into the buttocks every two weeks, administered by a health care professional.
RISPERDAL CONSTA jingħata bħala injezzjoni ġol- muskolu tal- warrani kull ġimgħatejn, minn professjonist/ a fil- qasam mediku.
Adults Starting dose If your daily dose of oral (e. g. tablets) risperidone was 4 mg or less for the last two weeks, your starting dose should be 25 mg RISPERDAL CONSTA.
Adulti Doża tal- bidu Jekk id- doża tiegħek ta ’ kuljum ta ’ risperidone mill- ħalq (eż. pilloli) kienet ta ’ 4 mg jew anqas għal dawn l- aħħar ġimgħatejn, id- doża tiegħek tal- bidu għandha tkun ta ’ 25 mg RISPERDAL CONSTA.
If your daily dose of oral (e. g. tablets) risperidone was more than 4 mg for the last two weeks, you may be given 37.5 mg RISPERDAL CONSTA as a starting dose.
Jekk id- doża tiegħek ta ’ kuljum ta ’ risperidone mill- ħalq (eż. pilloli) kienet ta ’ aktar minn 4 mg għal dawn l- aħħar ġimgħatejn, inti tista ’ tingħata 37. 5 mg RISPERDAL CONSTA bħala doża tal- bidu.
If you are currently treated with other oral antipsychotics than risperidone, your starting dose of RISPERDAL CONSTA will depend on your current treatment.
Jekk inti bħalissa qed tiġi kkurat b’ antipsikotiċi orali oħrajn minbarra risperidone, id- doża tiegħek tal - bidu ta ’ RISPEDAL CONSTA tiddependi fuq il- kura tiegħek bħalissa.
Your doctor will choose RISPERDAL CONSTA 25 mg or 37.5 mg.
It- tabib tiegħek jagħżel RISPERDAL CONSTA 25 mg jew 37. 5 mg.
You may be given a lower dose of 12.5 mg.
Tista tingħata doża iktar baxxa ta ’ 12. 5 mg.
Your doctor will decide on the dose of RISPERDAL CONSTA that is right for you.
It- tabib tiegħek jiddeċiedi dwar id- doża ta ’ RISPERDAL CONSTA li hija tajba għalik.
Maintenance dose • The usual dose is 25 mg every two weeks as an injection • A lower dose of 12.5 mg or a higher dose of 37.5 or 50 mg may also be necessary.
59 Doża ta ’ manteniment • Id- doża li s- soltu tingħata hija 25 mg kull ġimgħatejn bħala injezzjoni. • Doża iktar baxxa ta ’ 12. 5 mg jew doża iktar ogħla ta ’ 35. 7 jew 50 mg tista ’ wkoll tkun meħtieġa.
Your doctor will decide on the dose of RISPERDAL CONSTA that is right for you • Your doctor may prescribe oral RISPERDAL for the first three weeks following your first injection.
It- tabib tiegħek jiddeċiedi dwar id- doża ta ’ RISPERDAL CONSTA li hija tajba għalik. • It- tabib tiegħek jista ’ jiktiblek RISPERDAL li jittieħed mill- ħalq għall- l- ewwel tliet ġimgħat wara l- ewwel injezzjoni tiegħek.
Children and adolescents RISPERDAL CONSTA is not for people who are under 18 years old.
Tfal u adoloxxenti RISPERDAL CONSTA m’ huwiex qiegħed għall- persuni li għandhom taħt it- 18- il sena.
57 • People who have been given more RISPERDAL CONSTA than they should have experienced the following symptoms: sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Jekk tingħata RISPERDAL CONSTA aktar milli suppost • Persuni li ngħataw RISPERDAL CONSTA aktar milli suppost ħassew is- sintomi li ġejjin: ngħas, għejja, temperatura tal- ġisem mhix normali, movimenti fil- ġisem mhux normali, problemi biex joqogħodu bilwieqfa u jimxu, sturdament minħabba pressjoni baxxa u qalb ma tħabbatx b’ mod normali.
Cases of abnormal electrical conduction in the heart and convulsion have been reported • See a doctor right away.
Każijiet ta ’ konduzzjoni elettrika mhux normali fil- qalb u konvulżjonijiet kienu rrappurtati • Ara tabib immedjatament..
If you stop using RISPERDAL CONSTA You will lose the effects of the medicine.
Jekk tieqaf tuża RISPERDAL CONSTA Inti tiltlef l- effett tal- mediċina.
You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
M’ għandekx tieqaf tuża din il- mediċina sakemm it- tabib tiegħek ma jgħidlekx tagħmel dan minħabba li s- sintomi tiegħek jistgħu jerġgħu jitfaċċaw.
Be sure not to miss your appointments when you are supposed to receive your injections every two weeks.
Kun żgur/ a li ma tfallix appuntamenti li jkollok biex tirċievi l- injezzjonijiet kull ġimgħatejn.
If you cannot keep your appointment, be sure to contact your doctor right away to discuss another date when you can come in for your injection.
Jekk ma tistax iżżomm l - appuntament tiegħek, żgura li tikkuntattja lit- tabib tiegħek immedjatament biex tiddiskuti data oħra meta tista ’ tmur għall- injezzjoni.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, RISPERDAL CONSTA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra RISPERDAL CONSTA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.
jaffettwaw aktar minn persuna waħda li tużah minn kull 10 jaffettwaw minn 1 sa 10 persuna li tużah minn kull 100 jaffettwaw minn 1 sa 10 persuna li tużah minn kull 1, 000 jaffettwaw minn 1 sa 10 persuna li tużah minn kull 10, 000 jaffettwaw anqas minn persuna waħda li tużah minn kull 10, 000
The following side
Mhux magħruf: ma tistax tittieħed stima mid- data disponibbli.
effects may happen:
L- effetti sekondarji li ġejjin jistgħu jiġru:
Very common side effects (affects more than 1 user in 10): • Inability to sleep, anxiety, depression, irritability, feeling of inner restlessness • Headache, nose and throat infection • Parkinsonism.
Effetti sekondarji komuni ħafna (jaffettwaw aktar minn persuna waħda li tużah minn kull 10): • Ma tkunx tista ’ torqod, ansjetà, depressjoni, irritabilità, tħoss nuqqas ta ’ kwiet minn ġewwa • Uġigħ ta ’ ras, infezzjoni ta ’ l- imnieħer u l- gerżuma • • Parkinsoniżmu.
This is a medical term that includes many symptoms.
Din hija kelma medika li tinkludi ħafna sintomi.
Each individual symptom may occur less frequently than in 1 in 10 people.
Kull sintomu individwali jista ’ jseħħ f’ anqas minn 1 minn kull 10 persuni.
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).
Parkinsoniżmu jinkludi żieda fit- tnixxija tal- bżiq 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)
Common side effects (affects 1 to 10 users in 100): • Restlessness, sleep disorder, dizziness, feeling dizzy when staying still, fatigue, drowsiness, sleepiness • Weight increased, toothache, weight decreased • Vomiting, diarrhea, constipation, nausea, dry mouth, abdominal pain or stomach discomfort, stomach infection • Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, urinary tract infection, increase in body temperature, urinary incontinence, sinus infection, viral infection, ear infection, nose congestion, sore throat, ‘ pink eye’, flu-like illness, cough • Blurred vision • Tremor, muscle weakness, fall, back pain, muscle spasm, pain in arms and legs, joint pain, involuntary movement of face or limb muscles, muscle pain, swelling of the arms and legs • Blood prolactin hormone level increased, liver enzymes increased, decrease in hemoglobin or red blood cell count (anemia), blood sugar increased • No menstruation, erectile dysfunction, breast discharge • Abnormal electrical conduction of the heart, high blood pressure, fast beating heart, chest pain, low blood pressure, abnormal electrical tracing of the heart (ECG) • Rash, injection site pain, skin redness.
60 • Nuqqas ta ’ kwiet, disturb fl- irqad, sturdament, tħossok sturdut meta ma tkunx qed tiċċaqlaq, għeja kbira, ħedla, xejra ta ’ ngħas, • Żieda fil- piż, uġigħ tas- snien, tnaqqis fil- piż • Rimettar, dijarrea, stitikezza, dardir, ħalq xott, uġigħ addominali jew skomfort fl- istonku, infezzjoni fl- istonku • Diffikultà fit- teħid tan- nifs, infezzjoni fil- pulmun (pulmonite), influwenza, infezzjoni tal - passaġġi tan- nifs, infezzjoni fl- apparat ta ’ l- awrina, żieda fit- temperatura tal- ġisem, inkontinenza ta ’ l- awrina, infezzjoni fis- sinus, infezzjoni virali infezzjoni fil- widnejn, konġestjoni fl- imnieħer, uġigħ tal- gerżuma, ‘ għajn roża ’, mard bħal ta ’ l- influwenza, sogħla • Vista mċajpra • Rogħda, dgħjufija fil- muskoli, waqa ’, uġigħ fid- dahar, spażmu fil- muskoli, uġigħ fid- dirgħajn u s- saqajn, uġigħ fil- ġogi, moviment involuontarju tal- muskoli tal- wiċċ jew tad- dirgħajn u s - saqajn, uġigħ fil- muskoli, nefħa fid- dirgħajn u s- saqajn, • Żieda fil- livell ta ’ l- ormon tal- prolactin fid- demm, żieda fl- enzimi tal- fwied, tnaqqis fl - emoglobina jew fl- għadd taċ- ċelluli ħomor tad- demm (anemija), żieda fil- livell taz- zokkor fid - demm • Ma jkunx hemm menstrwazzjoni, disfunzjoni erettili, tnixxija mis- sider • Konduzzjoni elettrika tal- qalb mhix normali, pressjoni għolja, qalb tħabbat tgħaġġel, uġigħ fis - sider, pressjoni baxxa, traċċa elettrika tal- qalb (ECG) mhix normali • Raxx, uġigħ fis- sit ta ’ l- injezzjoni, ħmura fil- ġilda
58 Uncommon side effects (affects 1 to 10 users in 1000): • Nervousness, poor attention, feeling very sleepy, exhausted, or weary, excessive sleep, elated mood (mania), feeling ‘ out of sorts’, sluggishness • Nasal congestion • Bladder infection, stomach and intestine infection, ear pain • Sudden swelling of lips and eyes along with difficulty breathing, allergy • Neck pain, buttock pain, musculoskeletal chest pain, pain during injection procedure, chest discomfort, swelling and thickening of skin at injection site • Decreased appetite, increased appetite • Sexual dysfunction, enlargement of breast in men, decreased sexual drive • Intense itching of the skin, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness of skin, abscess under the skin, hair loss, acne, dry skin • Fainting, drop in blood pressure after standing, feeling dizzy after changing body position • Abnormal heart rhythm, awareness of heart beating, slow beating heart, • Body shakes rapidly and uncontrollably (convulsion) • Decrease in white blood cells that help against infection, decrease in platelets (blood cells that help you stop bleeding).
Effetti sekondarji mhux komuni (jaffettwaw minn 1 sa 10 persuna li tużah minn kull 1000): • Nervożiżmu, nuqqas t’ attenzjoni, tħossok bi ngħas ħafna, eżawrit jew għajjien, irqad eċċessiv, burdata ta ’ ferħ kbir (manija) tħossok ‘ mhux f’ sikktek ’, għażż • Kongestjoni nażali • Infezzjoni fil- bużżieqa ta ’ l- awrina, infezzjoni fl- istonku u fl- imsaren, uġigħ fil- widnejn • Xufftejn u għajnejn jintefħu f’ daqqa flimkien ma ’ diffikultà biex tieħu n- nifs, allerġija • Uġigħ fl- għonq, uġigħ fil- warrani, uġigħ muskolu- skelettrali fis- sider, uġigħ waqt il- proċedura ta ’ l- injezzjoni, skomfort fis- sider, il- ġilda tintefaħ u teħxien fis- sit ta ’ l- injezzjoni • Tnaqqis fl- apptit, żieda fl- aptit • Disfunzjoni sesswali, tkabbir tas- sider fl- irġiel, tnaqqis fl- aptit sesswali • Ħakk qawwi fil- ġilda, tnaqqis ta ’ sensazzjoni fil- ġilda għall- uġigħ u l- ħass, sensazzjoni ta ’ tnemnim, tingiz jew titrix fil- ġilda, axxess taħt il- ġilda, xagħar jaqa ’, akne, ġilda xotta • Ħass ħażin, pressjoni titbaxxa mal- waqfien, tħossok stordut/ a wara li tbiddel il- pożizzjoni tal - ġisem • Ritmu mhux normali tal- qalb, tkun konxju ta ’ qalbek tħabbat, qalb tħabbat bil- mod • Ġisem jirtogħod b’ mod mgħaġġel u mingħajr kontroll (aċċessjoni) • Tnaqqis fiċ- ċelluli bojod tad- demm li jgħinu kontra infezzjoni, tnaqqis fil- plejtlits (ċelluli tad - demm li jgħinu l- fsada tieqaf).
Rare side effects (affects 1 to 10 users in 10,000): • Trouble breathing during sleep • Obstruction of intestine • Yellowing of the skin and the eyes (jaundice) • Inappropriate secretion of a hormone that controls urine volume • Inflammation of the pancreas.
Effetti sekondarji rari (jaffettwaw minn 1 sa 10 persuna li tużah minn kull 10, 000): • Diffikultà biex tieħu n- nifs waqt l- irqad • Sadd ta ’ l- intestina • Sfura fil- ġilda u fl- abjad ta ’ l- għajnejn (suffejra) • Tnixxija mhux xierqa ta ’ l- ormon li jikkontrolla l- volum ta ’ l- awrina • Infjammazzjoni tal- frixa
Very rare side effects (affects less than 1 user in 10,000) may include: • Life-threatening complications of uncontrolled diabetes.
Effetti sekondarji rari ħafna (jaffettwaw anqas minn persuna waħda li tużah minn kull 10, 000) jistgħu jinkludu: • Kumplikazzjonijiet ta ’ dijabete mhux ikkontrollata ta ’ periklu għall- ħajja
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 • Sudden loss of vision or blindness.
Mhix magħrufa l- frekwenza li biha jseħħu (ma tistax tittieħed stima mid- data disponibbli): • Reazzjoni allerġika qawwija li twassal għal diffikultà biex tieħu n- nifs u xokk • Ma jkunx hemm granuloċiti (tip ta ’ ċellula bajda li tgħinek kontra l- infezzjoni)
RISPERDAL Oral The following side effects have been reported with the use of RISPERDAL Oral.
61 • Erezzjoni li ddum u tkun bl- uġigħ • Xorb ta ’ ammont eċċessiv u perikoluż ta ’ ilma • Telf f’ daqqa tal- vista jew telf tad- dawl
59 • Abnormal posture, joint stiffness, neck pain, breakdown of muscle and pain in muscles • Gait disturbance, edema, body temperature increased, drug allergy, speech disorder, movement disorder • Eosinophil (special white blood cells) count increased, blood creatine phosphokinase increased • Inability to reach orgasm, ejaculation disorder, menstrual disorder • Change in consciousness with increased body temperature and twitching of muscles • Flushing, oily skin inflammation, dandruff, rash all over the body • Discomfort, chills, arm or leg coldness, drug withdrawal syndrome.
Anke jekk m’ intix qed tieħu RISPERDAL li Jittieħed mill- Ħalq iżda tesperjenza kwalunkwe waħda minn dawn li ġejjin, kellem lit- tabib tiegħek: • Tpixxija involuntarja fis- sodda, diffikultà biex tagħmel l- awrina, tagħmel l- awrina f’ intevalli qosra, tnixxija mill- vaġina • Tonsillite, infezzjoni fl- għajnejn, infezzjoni fil- ġilda, infezzjoni tal- moffa fid- dwiefer • Nuqqas ta ’ emozzjoni, konfużjoni, nuqqas t’ attenzjoni, telf mis- sensi, disturb fil- bilanċ • Ma jirrispondix għall- istimuli, puplesija, nuqqas ta ’ demm li jmur lejn il- moħħ, disturb fl- arterji u l- vini tal- moħħ, dgħjufija jew titrix f’ daqqa fil- wiċċ, fid- dirgħajn u fis- saqajn, speċjalment fuq naħa waħda, jew mumenti ta ’ taħdid ma jiftehemx li jdumu anqas minn 24 siegħa (dawn jissejħu puplesiji żgħar jew puplesiji) • Għajnejn iħammġu, għajnejn iduru, nefħa fl- għajnejn, żarżir fil- widnejn, fsada mill- imnieħer, għajnejn xotti, żieda fid- dmugħ, sensittività eċċessiva għad- dawl bl- uġigħ, żieda fil- pressjoni fil- boċċa ta ’ l- għajn, ċarezza mnaqqsa tal- vista • Tħarħir, pulmonite ikkawżata minn ikel li jinġibed man- nifs, ħanqa, sogħla bil- bili, konġestjoni fil- pulmun, konġestjoni fil- passaġġi tan- nifs, ħoss ta ’ tifqigħat żgħar fil- pulmun, disturb fil - passaġġ tan- nifs, teħid tan- nifs qasir u mgħaġġel • Ippurgar iebes ħafna, inkontinenza ta ’ l- ippurgar, skomfort fl- addome, għatx, nefħa fix- xufftejn, infjammazzjoni tal- musrana l- kbira, tnaqqis fil- bżiq • Telf ta ’ kulur fil- ġilda, ferita fil- ġilda, disturb fil- ġilda, ġilda teħxien • Pożizzjoni tal- ġisem mhux normali, ebusija fil- ġogi, uġigħ fl- għonq, ħsara fil- fibra tal- muskolu u uġigħ fil- muskoli • Disturb fil- mixi, edima, żieda fit- temperatura tal- ġisem, allerġija għall- mediċini, disturb fit - taħdid, disturb fil- moviment • Żieda fl- għadd ta ’ eosinofils (ċelluli bojod speċjali), żieda fil- creatine phosphokinase fid- demm • Inabbiltà li tilħaq orgażmu, disturb fl- eġakulazzjoni, disturb fil- menstrwazzjoni • Bidla fil- koxjenza b’ temperatura tal- ġisem għolja u moviment involontarju f’ daqqa tal- muskoli • Fwawar, infjammazzjoni f’ ġilda żejtnija, brija, raxx mifrux mal- ġisem kollu • Skomfort, tkexkix ta ’ bard, kesħa fid- dirgħajn u s- saqajn, sindrome ta ’ twaqqif tal- mediċina
HOW TO STORE RISPERDAL CONSTA
KIF TAĦŻEN RISPERDAL CONSTA
Do not use RISPERDAL CONSTA after the expiry date which is stated on the carton.
Tużax RISPERDAL CONSTA wara d- data ta ’ skadenza li tidher fuq il- kartuna.
What RISPERDAL CONSTA contains
62 X’ fih RISPERDAL CONSTA
The active substance is risperidone.
Is- sustanza attiva hija risperidone.
Each RISPERDAL CONSTA powder and solvent for prolonged-release suspension for injection contains either 12.5 mg, 25 mg, 37.5 mg or 50 mg of risperidone.
Trab u solvent RISPERDAL CONSTA għal suspenzjoni li terħi l- mediċina bil- mod għall- injezzjoni fih 12. 5 mg, 25 mg, 37. 5 mg jew 50 mg ta ’ risperidone.
Solvent (solution)
Solvent (soluzzjoni)
What RISPERDAL CONSTA looks like and contents of the pack
Id- dehra ta ’ RISPERDAL CONSTA u l- kontenut tal- pakkett
[To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari.]
RISPERDAL® CONSTA®
RISPERDAL® CONSTA® L- Awstrija:
RISPERDAL® CONSTA®/ BELIVON® CONSTA® Bulgaria:
RISPERDAL® CONSTA® / BELIVON® CONSTA® Il- Belġju:
РИСПОЛЕПТ КОНСТА™ Cyprus:
Ċipru:
RISPERDAL® CONSTA®
РИСПОЛЕПТ КОНСТА™ RISPERDAL® CONSTA® RISPERDAL® CONSTA®
RISPERDAL® CONSTA® Denmark:
RISPERDAL® CONSTA® Id- Danimarka:
RISPERDAL® CONSTA® Estonia:
RISPOLEPT® CONSTA® L- Estonja:
France:
RISPERDAL® CONSTA® Il- Finlandja:
RISPOLEPT® CONSTA® RISPERDAL® CONSTA® RISPERDALCONSTA® LP
RISPERDALCONSTA® LP Franza:
RISPERDAL CONSTA / Risperidon-Janssen CONSTA Greece:
Il- Greċja:
RISPERDAL CONSTA Iceland:
L- Islanda:
Lithuania:
Il- Litwanja:
RISPOLEPT® CONSTA®
Il- Latvja:
RISPERDAL® CONSTA® RISPERDAL® CONSTA® / BELIVON® CONSTA® RISPERDAL® CONSTA® RISPERDAL® CONSTA®
RISPERDAL CONSTA RISPERDAL® CONSTA® RISPERDAL® CONSTA™ RISPERDAL® RISPOLEPT® CONSTA® RISPOLEPT® CONSTA® RISPERDAL® CONSTA®
Poland:
Il- Lussemburgu:
RISPERDAL® CONSTA® RISPOLEPT CONSTA®
RISPERDAL® CONSTA® / BELIVON® CONSTA® RISPERDAL® CONSTA® Malta:
Portugal:
RISPERDAL® CONSTA® L- Olanda:
RISPERDAL® CONSTA® Romania:
RISPERDAL® CONSTA® In- Norveġja:
RISPOLEPT CONSTA® Slovakia:
RISPOLEPT CONSTA® Il- Polonja:
RISPERDAL® CONSTA® Slovenia:
RISPERDAL® CONSTA® Is- Slovakkja:
RISPERDAL CONSTA® Spain:
RISPERDAL CONSTA® Slovenja:
Sweden:
RISPERDAL® CONSTA Spanja:
RISPERDAL® CONSTA RISPERDAL® CONSTA®
RISPERDAL® CONSTA® L- Isvezja:
RISPERDAL® CONSTA®
63 RISPERDAL® CONSTA® Ir- Renju Unit:
61 IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS
64 INFORMAZZJONI IMPORTANTI GĦALL- PROFESSJONISTI FIL- QASAM MEDIKU
Instructions for Needle-Free Vial Access Device RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringesupplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Struzzjonijiet għall- Apparat ta ’ Aċċess għal- Kunjett Mingħajr Labra Mikrosferi RISPERDAL CONSTA li jintreħew bil- mod li qegħdin fil- kunjett għandhom jiġu rikostitwiti biss fis- solvent ta ’ ġos- siringa pprovduta fil- pakkett tad- doża, u għandu jingħata biss bil - labra ta ’ sigurtà Needle- Pro pprovduta fil- pakkett tad- doża.
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
Kontenut tal- pakkett tad- doża:
Contents of the dose pack: • One vial containing RISPERDAL CONSTA extended release microspheres • One Alaris SmartSite needle-free vial access device for reconstitution • One prefilled syringe containing 2 ml solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle-with needle protection device).
· Labra Needle- Pro waħda għall- injezzjoni ġol- muskolu (labra ta ’ sigurtà 20G 2 "TW b’ apparat
Flip off the plastic colored cap from the vial
Aqla l- għatu tal- plastik ikkulurit mill- kunjett
Peel back the blister pouch and remove the vial access device by holding the white luer cap.
Qaxxar il- folja forma ta ’ borża u neħħi l- apparat ta ’ aċċess għall- kunjett billi żżomm l- għatu luer abjad.
With a straight push down movement press the spike tip of the vial access device through the center of the vial’ s rubber stopper until the device securely snaps onto the vial top.
B’ imbottatura dritta l- isfel agħfas il- ponta tal- metall ta ’ l - apparat ta ’ aċċess għall- kunjett, biex tinfed iċ- ċentru tat- tapp tal- gomma tal- kunjett sakemm l - apparat jaqbad b’ mod sod mal- parti ta ’ fuq tal- kunjett.