qanastek/EMEA-V3 huggingface dataset:
Using the metering pump to dispense the oral solution The nozzle has two positions and can be turned gently – anti-clockwise (unlocked position) and clockwise (locked position).
Kif tuża l- pompa tad- dożaġġ sabiex tieħu s- soluzzjoni orali Iż- żennuna għandha żewġ pożizzjonijiet u tista tiddawwar ġentilment – lejn ix- xellug (pożizzjoni miftuħa) u lejn il- lemin (pożizzjoni maqfula).
In the locked position, the nozzle cannot be pressed down and no oral solution can be discharged.
Fil- pożizzjoni maqfula ż- żennuna ma tistax tiġi magħfusa ‘ l isfel u għalhekk is- soluzzjoni orali ma toħroġx.
The unlocked position is the normal position for discharging the oral solution.
Il- pożizzjoni miftuħa hija l- pożizzjoni normali sabiex tinħareġ is- soluzzjoni orali.
The nozzle should be turned gently anti-clockwise until it cannot be turned any further (about one-quarter turn); the pump is then ready for use.
Dawwar ġentilment iż- żennuna lejn ix- xellug sakemm ma tistax iddur iżjed (daqs kwart ta ’ dawra); imbagħad il- pompa hija lesta biex tintuża.
Dosing the oral solution Preparing the metering pump for dosing When the pump is pressed for the first time it will not discharge the correct quantity of oral solution.
Kif tħejji d- doża tas- soluzzjoni orali Kif tipprepara l- pompa għad- dożaġġ Meta l- pompa tingħafas l- ewwel darba din ma toħroġx il- kwantita` korretta tas- soluzzjoni orali.
Therefore, the pump must be prepared (primed) by fully pressing down the nozzle 3 times; the oral solution which comes out of the nozzle should be disposed of.
Għalhekk il- pompa għanda tiġi ppreparata għall- użu billi tagħfas iż- żennuna ‘ l isfel kompletament għal 3 darbiet; is- soluzzjoni orali li toħroġ miż- żennuna għanda tintrema.
Thereafter, each pump will give the correct dose (1 ml containing 15 mg of the active substance mirtazapine).
Wara dan, kull darba li tippompja tingħata d- doża korretta (1ml li fih 15 mg tas- sustanza attiva mirtazapine).
Using the metering pump for normal dosing The bottle should be placed on a flat level surface, such as a table top.
Kif tuża l- pompa għal doża normali Poġġi l- flixkun fuq superfiċje ċatt, bħal per ezempju fuq wiċċ ta ’ mejda.
The nozzle should be pressed in a firm, smooth, continuous action (not too slowly) all the way down until it stops, holding a glass containing some water under the opening of the nozzle.
Iż- żennuna għanda tiġi magħfusa b’ azzjoni soda, regolari u kontinwa (mhux bil- mod wisq) s’ isfel nett sakemm tieqaf, waqt li żżomm tazza bi ftit ilma taħt il- fetħa taż- żennuna.
The nozzle can then be released and the pump is ready for the following dose.
Imbagħad itlaq iż- żennuna u l- pompa hija lesta għad- doża li jmiss.
Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly
Jekk xorta waħda
If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
93 tittieħed deċiżjoni, ibbażata fuq bżonn kliniku, sabiex jingħata trattament, il- pazjent għandu jiġi segwit bir- reqqa għal apparizzjoni ta ’ sintomi suwiċidali.
With regard to the chance of suicide, in particular at the beginning of treatment, only a limited quantity of Remeron oral solution should be given to the patient.
Għar- rigward tal- possibilita` ta ’ suwiċidju, b’ mod partikolari fil- bidu tat- trattament, għanda tingħata kwantita` limitata ta ’ s- soluzzjoni orali Remeron lill- pazjent.
The average plasma concentration of mirtazapine was about 55% increased. – renal impairment:
Il- konċentrazzjoni medja tal- plażma ta ’ mirtazapine żdiedet b’ madwar 55%.
No significant differences were found in patients with mild renal impairment (creatinine clearance < 80 ml/ min) as compared to the control group.
Ma nstabux differenzi sinjifikanti f’ pazjenti b’ indeboliment renali ħafif (tneħħija ta ’ cretainine < 80 ml/ min) meta pparagunati mal- grupp tal - kontroll.
95 – cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarct, where normal precautions should be taken and concomitant medicines carefully administered. – low blood pressure. – diabetes mellitus:
- mard kardijaku bħal disturbi tal- konduzzjoni, angina pectoris u infart mijokardjali riċenti, fejn
Like with other antidepressants, the following should be taken into account: – Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified. – When the depressive phase of bipolar disorder is being treated, it can transform into the manic phase.
bi skiżofrenja jew disturbi psikotiċi oħrajn; ħsibijiet paranojiċi jistgħu jiġu intensifikati.
Patients with a history of mania/ hypomania should be closely monitored.
Mirtazapine għandu jitwaqqaf f’ pazjenti li jidħlu fil- fażi manika.
Mirtazapine should be discontinued in any patient entering a manic phase. – Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms.
- Għalkemm Remeron mhux vizzjuż, esperjenza ta ’ wara l- tqegħid fuq is- suq turi li terminazzjoni
Maltitol liquid This medicinal product contains maltitol liquid.
Maltitol Likwidu Dan il- prodott mediċinali fih il- maltitol likwidu.
Ethanol This medicinal product contains small amounts of ethanol, less than 100 mg per daily dose.
Ethanol
Switching from tablets to oral solution
95 Din il- mediċina fiha ammonti zgħar ta ’ ethanol inqas minn 100 mg għal kull doża ta ’ kulljum.
96 There are slight pharmacokinetic differences between oral solution and tablets; although these differences are likely to be of no clinical relevance, care should be taken when switching from tablets to oral solution.
Bidla minn pilloli għal soluzzjoni orali Hemm differenzi farmakokinetiċi żgħar bejn is- soluzzjoni orali u l- pilloli; għalkemm x’ aktarx dawn id- differenzi m’ għandhomx ikunu ta ’ rilevanza klinika, għanda tingħata attenzjoni meta teqleb minn pilloli għal soluzzjoni orali.
- Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in
- Mirtazapine f’ doża ta ’ 30mg darba kuljum ikkawżat żieda żgħira imma statistikament
the international normalized ratio (INR) in subjects treated with warfarin.
sinjifikanti fir- razzjon normalizzat internazzjonali (INR) f’ suġġetti ttrattati b’ warfarin.
4.8 Pregnancy and lactation
4. 6 Tqala u effetti fuq il- ħalib tas- sider
Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts.
96 Studji fuq annimali u tagħrif limitat fuq il- bniedem wrew ħruġ f’ ammonti żgħar ta ’ mirtazapine fil - ħalib tas- sider.
97 Remeron has minor or moderate influence on the ability to drive and use machines.
Remeron għandu influwenza żgħira jew moderata fuq il- ħila biex issuq u tħaddem magni.
The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo.
Il- meta- analiżi kkonċernat 20 prova, b’ durata ta ’ trattament ippjanata sa 12- il ġimgħa, b’ 1501 pazjent (134 sena ta ’ persuni) li irċevew dożi ta ’ mirtazapine sa 60 mg u 850 pazjent (79 sena ta ’ persuni) li rċevew plaċebo.
Table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials statistically significantly more frequently during treatment with Remeron than with placebo, added with adverse reactions from spontaneous reporting.
Tabella 1turi l- inċidenza kategorizzata tal- effetti mhux mixtieqa li seħħew fi provi kliniċi b’ mod statistikament sinjifikanti iktar frekwenti waqt it- trattament b’ Remeron milli bi plaċebo, miżjuda ma ’ effetti mhux mixtieqa rrapurtati spontanjament.
Lethargy1 Dizziness Tremor
Letarġija1,
Paraesthesia2 Restless legs Syncope
Paraesteżija2
Myoclonus
mijoklonus
Convulsions (insults) Serotonin syndrome Oral paraesthesia
konvulżjoniji
Gastrointestinal disorders
Sedazzjoni1, 4
Dry mouth
Sturdament
Nausea3 Diarrhea2 Vomiting2
Aġitazzjoni
Oral hypoaesthesia
et (insulti)
Mouth oedema
Uġigħ ta ’ ras2
Skin and subcutaneous tissue disorders
Tregħid Nawsja3
Exanthema2
fir- riġlejn sinkope
Musculoskeletal and connective tissue disorders
serotonin syndrome paraesteżija orali
Arthralgia Myalgia Back pain1
Disturbi gastro -
Metabolism and nutrition disorders
Ħalq xott
Increase in appetite1
ipoesteżija
Hyponatraemia
edema tal -
Vascular disorders General disorders
97 intestinali Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda Disturbi muskolu - skeltrali u tal - connective tissue
Orthostatic hypotension Oedema
Dijarrea2 iremettar2 Raxx fil- ġilda2 (exanthema) Arthralgia Uġigħ fil - muskoli (Myalgia) Uġigħ fid - dahar1
Hypotension2
ħalq
98 System organ class and administration site conditions
Disturbi fil - metaboliżmu u n - nutrizzjoni
Very common (≥ 1/ 10)
Żieda fl- aptit1
Common (≥ 1/ 100 to < 1/ 10) peripheral1 Fatigue
Disturbi vaskulari Disturbi ġenerali u kondizzjonijiet ta’ mnejn jingħata Disturbi fil- fwiet u fil- marrara
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Pressjoni baxxa ħafna (ortostatika) Edema periferali1 għejja
Rare (≥ 1/ 10,000 to < 1/ 1,000)
Pressjoni baxxa2
Frequency not known
Elevazzjoniji et fl- attivita` ta ’ serum transaminase s.
Hepatobiliary disorders
Inkubi2
Elevations in serum transaminase activities
Disturbi psikjatriċi
Psychiatric disorders
Ħolm anormali
Abnormal dreams Confusion Anxiety2, 5 Insomnia3, 5
Ideazzjoni suwiċidali6
Nightmares2 Mania Agitation2 Hallucinations Psychomotor restlessness (incl. akathisia, hyperkinesia)
Konfużjoni
Suicidal ideation6 Suicidal behaviour6
Manija
Endocrine disorders 1
Disturbi fis- sistema endokrinarja 1
Inappropriate antidiuretic hormone secretion
Anzjeta`2, 5 Insomnja3, 5
In clinical trials these events occurred statistically significantly more frequently during treatment with Remeron than with placebo.
Akathisia, iperkinesia)
4 N. B. dose reduction generally does not lead to less somnolence/ sedation but can jeopardize antidepressant efficacy 5 Upon treatment with antidepressants in general, anxiety and insomnia (which may be symptoms of depression) can develop or become aggravated.
Riduzzjoni fid- doża ġeneralment ma twassalx għal sonnolenza/ sedazzjoni imma jista ’ jippreġudika l- effikaċja antidipressanti 5 Bi trattament b’ anti dipressanti in ġenerali, jistgħu jiżviluppaw jew jiġu aggravati l- anzjeta` jew insomnja (li jistgħu jkunu sintomi ta ’ dipressjoni).
After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50%), reaching peak plasma levels after approx. one hour.
Wara amministrazzjoni orali ta ’ Remeron, is- sustanza attiva mirtazapine hija assorbita rapidament u tajjeb (bijodisponibilita` ≈ 50%), tilħaq l- ogħla livelli plażma wara madwar sagħtejn.
The half-life of elimination is sufficient to justify once-a-day dosing.
Iż- żmien ta ’ eliminazzjoni biex jinżel il- valur għal nofs hija suffiċjenti biex tiġġustifika dożaġġ ta ’ darba kuljum.
At two-fold systemic exposure compared to maximum human therapeutic exposure, there was an increase in post-implantation loss, decrease in the pup birth weights, and reduction in pup survival during the first three days of lactation in rats.
F’ esposizzjoni sistemika għal darbtejn meta mqabbel ma ’ esposizzjoni terapewtika umana massima, kien hemm żieda fit- telf wara l- impjantazzjoni, tnaqqis fil - piż tat- twelid tal- ġriewi, u tnaqqis fir- rata ta ’ sopravivenza taż- żgħar fl- ewwel tlett ijiem ta ’ treddigħ fil- firien.
6.1 List of excipients
99 6. 1 Lista ta ’ sustanzi mhux attivi
L-methionine sodium benzoate (E211) saccharin sodium (E954) citric acid monohydrate (E330) glycerol (E422) maltitol liquid (E965) orange tangerine flavour No.
L- methionine sodium benzoate (E211) saccharin sodium (E954) citric acid monohydrate (E330) glycerol (E422) maltitol liquid (E965) orange tangerine flavour No.
PHL-132597 (contains ethanol) purified water
PHL- 132597 (fih ethanol) ilma ppurifikat
The oral solution should not be mixed with fluids other than water.
Is- soluzzjoni orali m’ għanda titħallat ma ’ l- ebda fluwidu ħlief ilma.
100 2 years Shelf life after first opening of the bottle:
Sentejn Żmien kemm idum tajjeb il- prodott wara li jinfetaħ il- flixkun l- ewwel darba:
6 weeks
6 ġimgħat
Do not store above 25 °C
Taħżinx f’ temperatura ‘ l- fuq minn 25 °C
The carton contains one brown (type III) glass bottle containing 66 ml of Remeron oral solution and one metering pump.
Il- kartuna fiha flixkun wieħed kannella (tip III) tal- ħġieġ b’ 66 ml ta ’ soluzzjoni orali Remeron u pompa waħda tad- dożaġġ.
The supplied bottle with Remeron oral solution is closed with a sealed, polypropylene screw cap which has child-resistant features.
Il- flixkun supplit bis- soluzzjoni orali Remeron huwa magħluq b’ tapp tal- polipropelin tal- kamin issiġillat li għandu karatteristiċi kontra l- użu mit- tfal.
The supplied metering pump is packed in a sealed polyethylene bag.
Il- pompa supplita hija ppakkjata f’ borża tal - politin issiġillata.
101 LABELLING
101 TIKKETTA
102 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
102 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Outer carton and label, 15 mg/ ml
Kartuna ta ’ barra u tikketta, 15 mg/ ml
Remeron and associated names (see Annex I) 15 mg/ ml oral solution [See Annex I - To be completed nationally]
Remeron u ismijiet assoċjati miegħu (Ara Anness I) 15 mg/ ml soluzzjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari]
1 ml of oral solution contains 15 mg mirtazapine
1 ml tas- soluzzjoni orali fih 15 mg mirtazapine
Maltitol liquid
Maltitol likwidu
Oral solution 1 bottle containing 66 ml
Soluzzjoni orali Flixkun wieħed li fih 66 ml
Do not use the bottle more than 6 weeks after opening.
Tużax il- flixkun għal iżjed minn 6 ġimgħat wara li jinfetaħ.
Do not store above 25 °C
103 Taħżinx f’ temperatura ‘ l- fuq minn 25 °C
104 PACKAGE LEAFLET
104 FULJETT TA ’ TAGĦRIF
Remeron and associated names (see Annex I) 15 mg/ ml oral solution
Remeron u ismijiet assoċjati miegħu (Ara Anness I) soluzzjoni orali 15 mg/ ml
Do not take Remeron • if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Remeron.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal mirtazapine jew sustanzi oħra ta ’
If so, you must talk to your doctor as soon as you can before taking Remeron. • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).
impedituri ta ’ monoamine oxidase (MAO- Is).
106 Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
106 Ħsibijiet suwiċidali u tiħżin tad- dipressjoni tiegħek Jekk inti qed tbati minn dipressjoni kultant jistgħu jgħaddulek ħsibijiet li tweġġa lilek inniffsek jew li toqtol lilek inniffsek.
John’ s Wort – Hypericum perforatum preparations (a
Oqgħod attent/ a meta tieħu Remeron flimkien ma ’:
107 herbal remedy for depression).
107 • antidepressanti bħal SSRIs, venlafaxine u L- tryptophan jew triptans (użati biex jikkuraw l - emigranja), tramadol (itaffi l- uġigħ), linezolid (antibijotiku), lithium (użat biex jikkura xi kundizzjonijiet psikjatriċi) u St.
In combination with these medicines Remeron can increase the drowsiness caused by these medicines. • medicines for infections: medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole) and medicines for HIV/ AIDS (such as HIV- protease inhibitors).
F’ kombinazzjoni ma ’ dawn il- mediċini Remeron jista jżid it- tħeddil ikkawżat minn dawn il - mediċini. • mediċini għall- infezzjonijiet: mediċini għal infezzjonijiet batteriċi (bħal erythromycin), mediċini għat- trattament ta ’ infezzjonijiet fungali (bħal ketoconazole) u mediċini għal HIV/ AIDS (bħal inibituri HIV- protease).
Important information about some of the ingredients of Remeron Remeron oral solution contains maltitol liquid.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Remeron Is- soluzzjoni orali Remeron fiha maltitol likwidu.
Remeron oral solution contains small amounts of ethanol (alcohol), less than 100 mg per daily dose.
108 Is- soluzzjoni orali Remeron fiha ammonti zgħar ta ’ ethanol (alkoħol), inqas minn 100 mg għal kull doża ta ’ kulljum.
108 Always take Remeron exactly as your doctor or pharmacist tells you to.
Dejjem għandek tieħu Remeron eżattament skond il- parir tat- tabib jew tal- ispiżjar tiegħek.
Take the oral solution as follows Take the oral solution orally.
Ħu s- soluzzjoni orali kif ser jingħad Ħu s- soluzzjoni orali mill- ħalq.
Drink your prescribed dose of Remeron oral solution in a glass or cup mixed with some water.
Ixrob id- doża preskritta tas- soluzzjoni orali Remeron f’ tazza jew kikkra mħallta ma ’ ftit ilma.
Remeron oral solution comes with a metering pump to help you measure your dose.
Is- soluzzjoni orali Remeron tiġi b’ pompa ta ’ dożaġġ biex tgħinek tkejjel id- doża tiegħek.
Preparing the Remeron metering pump for use Before you take Remeron, you need to fit the pump onto the bottle.
Biex tipprepara l- pompa ta ’ dożaġġ ta ’ Remeron għall- użu Qabel ma tieħu Remeron għandek tqabbad il- pompa mal- flixkun.
Take the screw cap off the bottle Press the cap downwards and turn it anticlockwise to break the seal.
Aqla t- tapp tal- kamin minn mal- flixkun Għafas it- tapp ‘ l isfel u dawwru lejn ix- xellug biex tkisser is- siġill.
Keep pressing and turning to unscrew the cap.
Kompli għafas u dawwar sabiex tħoll it- tapp.
This procedure is given in symbolic instructions on the top of the screw cap.
Din il- proċedura hija mogħtija b’ istruzzjonijiet simboliċi fuq it- tapp tal - kamin.
Fit the metering pump onto the bottle Take the pump out of its bag.
Qabbad il- pompa ta ’ dożaġġ mal- flixkun Oħroġ il- pompa minn ġol- borża tagħha.
Fit it onto the bottle, putting the plastic tube inside the bottle.
Qabbadha mal- flixkun u daħħal it- tubu tal- plastik ġol - flixkun.
Press the pump onto the top of the bottle, and turn it clockwise until it clicks tightly into place.
Għafas il- pompa għal fuq il- flixkun, u dawwar lejn il- lemin sakemm tikklikkja sewwa f’ postha.
Tighten the pump a little more to make sure it is firmly in place.
Issikka l- pompa ftit iżjed sabiex tkun ċert/ a li qiegħda sewwa f’ postha.
Turn the nozzle to the open position The nozzle has two positions – locked and open.
Dawwar iż- żennuna għall- pożizzjoni miftuħa Iż- żennuna għandha żewġ pożizzjonijiet – magħluqa u miftuħa.
When it is locked, no liquid will come out.
Meta hi magħluqa ma joħroġ l - ebda likwidu.
To open the nozzle, turn it anticlockwise as far as it will go (about one-quarter turn).
Biex tiftaħ iż- żennuna, dawwar lejn ix- xellug it- tul kollu (daqs kwart ta ’ dawra).
4. ‘ Prime’ the metering pump before you take Remeron The very first time you press the pump, it will not measure out the right amount of Remeron solution.
Ipprajmja l- pompa ta ’ dożaġġ qabel ma tieħu Remeron L- ewwel darba li tagħfas il- pompa, din ma tagħtix l- ammont tajjeb tas- soluzzjoni Remeron.
You need to prime it before your first dose.
Għandek bżonn tipprajmjaha qabel l- ewwel doża.
Place the bottle on a flat surface.
Waqqaf il- flixkun fuq superfiċje ċatta.
Hold a glass or cup under the nozzle (see picture).
Żomm tazza jew kikkra taħt iż- żennuna (ara stampa).
Press the nozzle down as far as it will go, three times.
Għafas iż- żennuna ‘ l isfel it- tul kollu, tlett darbiet.
Rinse away the liquid that comes out.
Laħlaħ mill- likwidu li joħroġ.
The pump is now ready for use.
Issa l- pompa hija lesta għall- użu.
Taking your dose of Remeron The pump is used to measure your dose.
Biex tieħu d- doża tiegħek ta ’ Remeron Il- pompa tintuża biex tkejjel id- doża.
Pour a little water into a glass or cup, and hold it under the nozzle.
Waddab ftit ilma f’ tazza jew kikkra, u żomm taħt iż- żennuna.
Each time you press the nozzle, the pump dispenses 15 mg of Remeron.
Kull darba li tagħfas iż- żennuna, il- pompa tagħti 15 mg ta ’ Remeron.
Press the nozzle down as far as it will go.
Għafas iż- żennuna ‘ l isfel it- tul kollu.
Use a firm, smooth action - not too slow.
Uża azzjoni soda u kontinwa – mhux bil- mod wisq.
You may need to press the nozzle more than once to get the dose your doctor has prescribed (see picture).
Jista jagħti l- każ li jkollok tagħfas iż- żennuna iżjed minn darba sabiex tagħmel id- doża li kitblek it- tabib (ara stampa) 5.
Drink the mixture all at once.
Ixrob it- taħlita kollha f’ daqqa.
109 Dose 15 mg 1 press 30 mg 2 presses 45 mg 3 presses
109 Doża 15 mg għafsa 1 30 mg 2 għafsiet 45 mg 3 għafsiet
If you still don’t feel better, your doctor may prescribe a higher dose.
Jekk tibqa ma tħossokx aħjar, it- tabib jista ’ jiktiblek doża ogħla.
If you take more Remeron than you should → If you or someone else have taken too much Remeron, call a doctor straight away.
Jekk tieħu Remeron aktar milli suppost: → Jekk inti jew xi ħadd ieħor jieħu Remeron aktar milli suppost, sejjaħ tabib immedjatament.
If you are supposed to take your dose twice a day • if you have forgotten to take your morning dose, simply take it together with your evening dose. • if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses. • if you have forgotten to take both doses, do not attempt to make up for the missed doses.
Jekk inti għandek tieħu s- soluzzjoni orali darbtejn kuljum • jekk inti insejt tieħu d- doża ta ’ filgħodu, sempliċement ħudha ma ’ d- doża ta ’ filgħaxija. • jekk inti insejt tieħu d- doża ta ’ filgħaxija, teħodiex mad- doża ta ’ filgħodu li jmiss; aqbiżha u kompli bid- dożi normali ta ’ filgħodu u filgħaxija. • jekk inti insejt tieħu ż- żewġ dożi, tippruvax tpatti għad- dożi li tlift.
POSSIBLE SIDE EFFECTS
110 Bħal kull mediċina oħra, Remeron jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Uncommon: • feeling elated or emotionally ‘high’ (mania) → Stop taking Remeron and tell your doctor straight away. • abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia) • restless legs • fainting (syncope) • sensations of numbness in the mouth (oral hypoaesthesia) • low blood pressure • nightmares • feeling agitated • hallucinations • urge to move
Mhux komuni: • tħossok ferħan iżżejjed jew emozzjonalment ‘ high ’ (manija) → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament. • sensazzjoni anormali fil- ġilda p. e. ħruq, tingiż, tagħrix jew textix (paraesteżija) • aġitazzjoni fir- riġlejn • ħass ħażin (sinkope) • sensazzjoni ta ’ tirżiħ fil- ħalq (ipoesteżija orali) • pressjoni baxxa tad- demm • ħmar il- lejl • tħossok eċitat/ a • alluċinazzjonijiet • bżonn li tiċċaqlaq
111 Not known: • signs of infection such as sudden inexplicable high fever, sore throat and mouth ulcers (agranulocytosis) → Stop taking Remeron and contact your doctor straight away for a blood test.
111 • sinjali ta ’ infezzjoni bħal deni għoli inspjegabbli f’ daqqa, uġigħ fil- griżmejn u ulċeri fil- ħalq (agranuloċitożi) → Ieqaf tieħu Remeron u kellem lit- tabib tiegħek immedjatament għal test tad- demm.
Do not use Remeron after the expiry date which is stated on the carton and the bottle.
Tużax Remeron wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- flixkun.
Do not store above 25 °C Do not use the bottle more than 6 weeks after opening.
Taħżinx f’ temperatura ‘ l- fuq minn 25 °C Tużax il- flixkun għal iktar minn 6 ġimgħat minn meta jinfetaħ.
Make a note of the date of opening of the bottle.
Żomm nota tad- data ta ’ meta ftaħt il- flixkun.
Remeron 15 mg/ml oral solution contains 15 mg mirtazapine per ml solution. • The other ingredients are L-methionine, sodium benzoate (E211), saccharin sodium (E954), citric acid monohydrate (E330), glycerol (E422), maltitol liquid (E965), orange tangerine flavour No.:
PHL- 132597 (fih ethanol) u ilma ppurifikat.
PHL-132597 (contains ethanol) and purified water.
Id- Dehra ta ’ Remeron u l- kontenuti tal- pakkett:
112 What Remeron looks like and contents of the pack
112 Is- soluzzjoni orali Remeron hija soluzzjoni ċara, mingħajr kulur jew isfar pallidu b’ riħa ta ’ ċitru - larinġ.
The carton contains one brown glass bottle with 66 ml of Remeron oral solution and one metering pump.
Il- kaxxa fiha flixkun wieħed kannella tal- ħġieġ b’ 66ml tas- soluzzjoni orali Remeron u pompa waħda ta ’ dożaġġ.
The bottle containing the oral solution is closed with a child-resistant screw cap and a seal which is broken when the cap is unscrewed.
Il- flixkun bis- soluzzjoni orali huwa magħluq b’ tapp tal- kamin reżistenti għat- tfal u b’ siġill li jinkiser meta t- tapp jiġi żvitat.
The metering pump is packed in a sealed plastic bag.
Il- pompa hija ppakkjata f’ borża tal- plastik issiġillata.
This leaflet was last revised/approved in.
Dan il- fuljett kien approvat l- aħħar f ’
London, 16 September 2008 EMEA/ CHMP/ 500252/ 2008
Londra, 16 ta ’ Settembru 2008 EMEA/ CHMP/ 500097/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Remeron and associated names
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 30 GĦAL Remeron u ismijiet assoċjati
International Non-Proprietary Name (INN): mirtazapine
Denominazzjoni Komuni Internazzjonali (DKI): mirtazapine
Remeron and associated names, 15, 30 and 45 mg tablets, 15, 30 and 45 mg orodispersible tablets, 15 mg/ ml oral solution, is a noradrenergic and specific serotonergic antidepressant indicated for the treatment of episodes of major depression.
Remeron u ismijiet assoċjati, pilloli ta ’ 15, 30 u 45 mg, pilloli li jdubu fl- ilma ta ’ 15, 30 u 45 mg, soluzzjoni orali ta ’ 15 mg/ ml, huwa antidipressant oradrenerġiku u serotonerġiku speċifiku indikat għall - kura ta ’ episodji ta ’ depressjoni maġġuri.
On 11 October 2007, N. V.
Fil- 11 ta ’ Ottubru 2007, N. V.
Organon 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, including quality aspects of the medicinal product Remeron and associated names.
Organon 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, inkluż aspetti ta ’ kwalità tal- prodott mediċinali Remeron u l- ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Remeron and associated names approved across EU Member States, with respect to treatment of major depressive episodes.
Il- bażi tar- riferiment kienet li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) inkluż fl- aspetti ta ’ kwalità ta ’ Remeron u l- ismijiet assoċjati approvati madwar l- Istati Membri tal- UE fir- rigward ta ’ kura ta ’ episodji dipressivi maġġuri.
The procedure started on 15 November 2007.
Il- proċedura bdiet fil- 15 ta ’ Novembru 2007.
The Marketing Authorisation Holder provided supplementary information on 19 March 2008
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ta informazzjoni supplimentari fid- 19 ta ’ Marzu 2008.
During its June 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 including the quality aspects was acceptable and that they should be amended.
Matul il- laqgħa tiegħu ta ’ Ġunju 2008, il- CHMP, fid- dawl tad- dejta ġenerali ippreżentata u tad- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, it- Tikketta u l - Fuljett ta ’ Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Remeron and associated names.
Il- CHMP ta opinjoni pożittiva fis- 26 ta ’ Ġunju 2008 u rrakkomanda l- armonizzazzjoni tal- SPC, Tikketta u Fuljett ta ’ Tagħrif inkluż l- aspetti ta ’ kwalità għal Remeron u l- ismijiet assoċjati.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Il- konklużjonijiet xjentifiċi huma mogħtija fl- Anness II flimkien mal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif emendati fl- Anness III.
A Decision was issued by the European Commission on 15 September 2008.
Inħarġet Deċiżjoni mill- Kummissjoni Ewropea fil- 15 ta ’ Settembru 2008.
Invented Name
Isem Ivvintat
Content (concentration)
Il- Kontenut (Konċentrat)
Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Austria
Janssen- Cilag Pharma GmbH Risperdal Consta Pfarrgasse 75, 1232 Wien, L - Awstrija
Powder and solvent for prolonged-release suspension for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Austria
Janssen- Cilag Pharma GmbH Rispolin Consta Pfarrgasse 75, 1232 Wien, L - Awstrija
Austria
Qawwa
Roderveldlaan 1, 2600 Berchem, Belgium
Belivon Consta Roderveldlaan 1, 2600 Berchem, Il- Belġju
Powder and solvent for Intramuscular use solution for injection
Trab u solvent għal soluzzjoni għall injezzjoni
Member State
Il- Belġju
Roderveldlaan 1, 2600 Berchem, Belgium
Risperdal Consta Roderveldlaan 1, 2600 Berchem, Il- Belġju
Smartinska cesta 53, 1000 Ljubljana, Slovenia
Rispolept Consta Smartinska cesta 53, 1000 Ljubljana, Slovenja
Smartinska cesta 53, 1000 Ljubljana, Slovenia
Rispolept Consta Smartinska cesta 53, 1000
Powder and solvent for Intramuscular use solution for injection
Trab u solvent għal soluzzjoni għall
Janssen-Cilag International NV, Risperdal Consta Belgium Turnhoutseweg 30, 2340 Beerse, Belgium
Janssen- Cilag International NV, Il- Belġju Turnhoutseweg 30, 2340 Beerse, Il- Belġju
Intramuscular use
Trab għal suspenzjoni Użu għal ġol - muskoli għall injezzjoni
Czech
Repubblika Ċeka
Risperdal Consta
Karla Engliše 3201/ 6, 15000 Praha 5, Repubblika Ċeka
Karla Engliš e 3201/ 6, 15000 Praha 5, Czech Republic
Trab u solvent għal Użu għal ġol - muskoli suspenzjoni għall injezzjoni
Karla Engliš e 3201/ 6, 15000 Praha 5, Czech Republic
Karla Engliše 3201/ 6, 15000 Praha 5, Repubblika Ċeka
Powder and solvent for Intramuscular use suspension for injection
Trab u solvent għal Użu għal ġol - muskoli suspenzjoni għall injezzjoni
Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Lithuania
Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Il- Litwanja
Powder and solvent for Intramuscular use suspension for injection
Trab u solvent għal suspenzjoni għall injezzjoni
Jansen-Cilag Oy Metsänneidonkuja 8 02130 Espoo Finland
Jansen- Cilag Oy Metsänneidonkuja 8 02130 Espoo Il- Finlandja
Powder and solvent for Intramuscular use prolonged-release suspension for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
Jansen-Cilag Oy Metsänneidonkuja 8
Jansen- Cilag Oy Metsänneidonkuja 8 02130 Espoo Il- Finlandja
Powder and solvent for Intramuscular use prolonged-release
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
Marketing Authorisation Holder
Użu għal ġol - muskoli
Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9 France
Janssen Cilag 1 rue Desmoulins TSA 91003 92787 Issy les Moulineaux Cedex 9 Franza
Powder for suspension Intramuscular use for injection
Użu għal ġol - muskoli
37.5 mg/ 2 ml
5 Stat Membru
Powder for suspension Intramuscular use for injection
Trab għal suspenzjoni Użu għal ġol - muskoli għall injezzjoni
8 41470 Neuss Germany
8 41470 Neuss Ġermanja
Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Greece
Janssen- Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Il- Greċja
Janssen-Cilag Pharmaceuticals
Janssen- Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Il- Greċja
Powder and solvent for Intramuscular use
Trab u solvent għal Użu għal ġol - muskoli suspenzjoni għall injezzjoni
Janssen-Cilag AB c/ oVistor hf. Hörgatúni 2 Garðabær, Iceland
Janssen- Cilag AB c/ oVistor hf. Hörgatúni 2 Garðabær, L- Islanda
Janssen-Cilag AB c/ oVistor hf. Hörgatúni 2 Garðabær, Iceland
Janssen- Cilag AB
Powder and solvent for Intramuscular use suspension for injection
Trab u solvent għal Użu għal ġol - muskoli
Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Janssen- Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ Ir- Renju Unit
Powder for Suspension Intramuscular use for Injection
Trab għal suspenzjoni Użu għal ġol - muskoli għall injezzjoni
23 Cologno Monzese, 20093, Milano, Italy
23 Cologno Monzese, 20093, Milano, L- Italja
Prolonged release powder and solvent for suspension for injection
Trab u solvent għal
UAB Johnson & Johnson, Š eimyniš kiu g.1A, Vilnius, Lithuania
UAB Johnson & Johnson, Šeimyniškiu g. 1A, Vilnius, Il - Litwanja
Prolonged release powder and solvent for suspension for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
UAB, ,Johnson & Johnson“, Š eimyniš kių g.
UAB,, Johnson & Johnson “, Rispolept Consta Šeimyniškių g.
1A, LT-09312 Vilnius, Lithuania
1A, LT- 09312 Vilnius, Il- Litwanja
Prolonged-release powder and solvent for solution for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
Janssen Cilag International NV Risperdal Consta Turnhoutseweg 30, 2340 Beerse, Il- Belġju
Powder for suspension for injection
Trab għal suspenzjoni għall injezzjoni
Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
Janssen Cilag International NV Risperdal Consta
37.5mg/ 2ml
37. 5mg/ 2ml
Malta
Qawwa
Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
Turnhoutseweg 30, 2340 Beerse, Il- Belġju
Risperdal Consta
għall injezzjoni
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg The Netherlands
Paul Janssenweg 150 PO Box 90240 5000 LT Tilburg The L- Olanda
Powder and solution for Intramuscular use suspension and injection
Trab u soluzzjoni għal Użu għal ġol - muskoli suspenzjoni u injezzjoni
Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway
Janssen- Cilag AS Hoffsveien 1D 0275 Oslo In- Norveġja
Prolonged-release Intramuscular use powder (microspheres) and a solvent for suspension for injection
Trab li jerħi bil- mod Użu għal ġol - muskoli (mikrosferi) u solvent għal suspenzjoni għall injezzjoni
9 Member State
10 Stat Membru
Hoffsveien 1D 0275 Oslo Norway
Hoffsveien 1D 0275 Oslo In- Norveġja
powder (microspheres) and a solvent for suspension for injection
(mikrosferi) u solvent għal suspenzjoni għall injezzjoni
Prolonged-release powder (microspheres) and a solvent for suspension for injection
Trab li jerħi bil- mod Użu għal ġol - muskoli (mikrosferi) u solvent għal suspenzjoni għall injezzjoni
Turnhoutseweg 30 2340 Beerse Belgium
Turnhoutseweg 30 2340 Beerse Il- Belġju
Prolonged-release microcapsule and solvent for suspension for injection
Mikrokapsula li terħi Użu għal ġol - muskoli bil- mod il - mediċina u solvent għal suspenzjoni għall injezzjoni
Janssen Farmacêutica Portugal Lda.
Janssen Farmacêutica Il - Portugall Lda.
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734- 503 Barcarena Il- Portugall
Pó e veículo para suspensão injectável
Trab u solvent għal Użu għal ġol - muskoli suspenzjoni għall injezzjoni
10 Member State
11 Stat Membru
Pharmaceutical Form Route of administration
jingħata
Janssen Farmacêutica Portugal Risperdal Consta Lda.
Janssen Farmacêutica Il - Portugall Lda.
Pó e veículo para suspensão injectável
Trab u solvent għal suspenzjoni għall injezzjoni
Turnhoutseweg 30, 2340 Beerse, Belgium
Turnhoutseweg 30, 2340 Beerse, Il- Belġju
Plynárenská 7/ B Bratislava Slovak Republic
Plynárenská 7/ B Bratislava Is- Slovakkja
Powder and solvent for Intramuscural use suspension for injection
Trab u solvent għal suspenzjoni għall injezzjoni
Prolonged release Intramuscural use powder and solvent for suspension for injection
Trab u solvent għal suspenzjoni li terħi l -
Slovenia
12 Stat Membru
Johnson & Johnson d. o. o.,
Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
Risperdal Consta
Isem Ivvintat
37,5 mg
Qawwa
Prolonged release Intramuscural use
Għamla Farmaċewtika Mnejn
37,5 mg/ 2 ml
jingħata
Marketing Authorisation Holder
Il- Kontenut (Konċentrat)
Strength
Slovenja
Pharmaceutical Form Route of administration
mediċina bil - mod għall injezzjoni
Content (concentration)
Slovenja
Š martinska 53, Ljubljana, Slovenia
Johnson & Johnson d. o. o., Šmartinska 53, Ljubljana, Slovenja
powder and solvent for suspension for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
Johnson & Johnson d. o. o., Š martinska 53, Ljubljana, Slovenia
Johnson & Johnson d. o. o., Šmartinska 53, Ljubljana, Slovenja
Prolonged release Intramuscural use powder and solvent for suspension for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall injezzjoni
JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Spain
JANSSEN CILAG, SA Paseo de las 12 estrellas, 5- 7 Madrid, Spanja
Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden
Janssen- Cilag AB Box 7073 192 07 Sollentuna L- Isvezja
Janssen-Cilag AB Box 7073 192 07 Sollentuna Sweden
Janssen- Cilag AB Box 7073 192 07 Sollentuna
Powder and solvent for Intramuscular use prolonged-release suspension for injection
Trab u solvent għal suspenzjoni li terħi l - mediċina bil - mod għall
Saunderton High-Wycombe Buckinghamshire HP 14 4HJ United Kingdom
Saunderton High- Wycombe Buckinghamshire HP 14 4HJ Ir- Renju Unit
14 SCIENTIFIC CONCLUSIONS
14 ANNESS II
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RISPERDAL CONSTA AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ RISPERDAL CONSTA U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Risperdal Consta (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Risperdal Consta (risperidone) huwa derivattiv ta ’ benzisoxazole b’ karatteristiċi qawwijin ta ’ imblokkar tar- receptor ta ’ serotonin 5HT2A u dopamine D2 ikkumbinati.
It is an effective atypical antipsychotic that is well tolerated, based on extensive clinical experience including long-term use.
Huwa antipsikotiku atipiku effettiv li huwa ttollerat sewwa, ibbażat fuq esperjenza klinika estensiva inkluż użu fit- tul.
The authorised formulation of Risperdal Consta is a prolonged-release formulation for intramuscular (i. m.) injection containing 12.5, 25, 37.5, or 50 mg risperidone.
Il - formulazzjoni awtorizzata ta ’ Risperdal Consta hija formulazzjoni ta ’ rilaxx fit- tul għall- injezzjoni intramuskolari (i. m.) li fiha 12. 5, 25, 37. 5, jew 50 mg risperidone.
The intramuscular long-acting injection (LAI) formulation provides slow and steady release of risperidone over a period of several weeks.
Il- formulazzjoni intramuskolari li taħdem fit- tul (LAI) tipprovdi rilaxx bil- mod u kostanti ta ’ risperidone fuq perijodu ta ’ diversi ġimgħat.
The Referral procedure under Article 30 of Directive 2001/ 83/ EC, as amended for Risperdal Consta was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to indications, special warnings and precautions for use and interaction with other medicinal products and other forms of interaction.
Il- proċedura ta ’ Riferenza skond l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendata għal Risperdal Consta inbdiet sabiex tirrisolvi diverġenzi fost it- testi tal- Fuljett ta ’ Tagħrif awtorizzati fuq livell nazzjonali madwar l- UE u fl- Istati Membri taż- ŻEE, b’ mod partikolari fir- rigward ta ’ indikazzjonijiet, twissijiet speċjali u prekawżjonijiet għall- użu u interazzjoni ma ’ prodotti mediċinali oħrajn u forom oħra ta ’ interazzjoni.
The CHMP assessed the proposed wording provided by the MAH, and particular attention was given to the following issues:
Is- CHMP ivvaluta l- formolazzjoni ta ’ kliem proposta pprovduta mill- MAH u ngħatat attenzjoni partikolari għall- argumenti li ġejjin:
For section 4.1, the indication “ schizophrenic disorders” was assessed in details, as the existing divergences were likely to have implications for the selection of the treatment population and for the dose regiment and concomitant treatments.
Għal sezzjoni 4. 1, l- indikazzjoni “ disturbi skiżofreniċi ” kienet ivvalutata fid- dettall, minħabba li kien probabbli li d- diverġenzi eżistenti kien sejjer ikollhom implikazzjonijiet għall- għażla tal- popolazzjoni tal- kura u għar- reġimen tad- doża u kuri konkomittanti.
The CHMP assessed the MAH responses and the submitted data, noting that Risperdal Consta was developed for the maintenance treatment of schizophrenia and adopting a harmonised wording that conveys the concept of a therapy to be administered after a disease has been brought under control.
Is- CHMP ivvaluta r- reazzjonijiet tal- MAH u d - dejta sottomessa, u nnota li Risperdal Consta ġie żviluppat għat- trattament ta ’ manteniment ta ’ l - iskizofrenija u adotta formolazzjoni ta ’ kliem armonizzata li twassal il- kunċett ta ’ kura li għandha tingħata wara li l- marda tkun ġiet taħt kontroll.
It was considered shown that it is not mandatory for patients to have been stabilised on oral medications, and even preferable that patients be switched to the long-acting injectable Risperdal Consta treatment, to increase adherence to the treatment.
Tqies li ntwera li mhuwiex obbligatorju għall- pazjenti li jkunu ġew stabbilizzati fuq medikazzjonijiet orali, u anki preferibbli li l- pazjenti jinqelbu għall- kura b’ Risperdal Consta injettabbli li taħdem fit- tul, biex tiżdied l- adeżjoni mal- kura.
However, the CHMP requested the MAH to further discuss the proposed wording of the indication, and the need to establish tolerability with oral risperidone prior to initiating treatment with Risperdal Consta.
Madankollu, is - CHMP talab lill- MAH biex jiddiskuti l- formolazzjoni ta ’ kliem proposta ta ’ l- indikazzjoni, u l- ħtieġa li tkun iġġustifikata t- tollerabbilità b’ risperidone orali qabel ma tinbeda l- kura b’ Risperdal Consta.
The MAH provided further justifications, being of the position that restricting the use of Risperdal Consta to patients with an initial treatment response to oral risperidone would be unjustified and would introduce an unnecessary and potentially prolonged additional step for the prescribing physicians, delaying access of Risperdal Consta to those patients who may not be adherent to their oral medication and who may be among the most suitable candidates for a long-acting injectable medication.
Il - MAH ipprovda iktar ġustifikazzjonijiet, minħabba li kien tal- fehma li r- restrizzjoni ta ’ l- użu ta ’ Risperdal Consta għall- pazjenti b’ rispons inizjali għall- kura b’ risperidone orali ma kinitx tkun iġġustifikata u kienet tintroduci pass addizzjonali mhux neċessarju u potenzjalment imtawwal għat - tobba li jkunu qegħdin jagħtuh b’ riċetta, b’ hekk jittardjaw l- aċċess għal Risperdal Consta għal dawk il- pazjenti li jistgħu ma jżommux mal- medikazzjoni orali tagħhom u li jistgħu jkunu fost l- iktar kandidati adatti għall- medikazzjoni injettabbli li taħdem fit- tul.
Based on the submitted data, the CHMP was of the opinion that the presented clinical data show that patients stabilised with any antipsychotic medication (oral or depot formulations) can safely be switched to Risperdal Consta and achieve a clinical benefit similar to that seen in patients being switched from oral risperidone and without a higher incidence of clinical deterioration.
Abbażi tat- tagħrif sottomess, is - CHMP kien ta ’ l- opinjoni li t- tagħrif kliniku ppreżentat juri li pazjenti stabbilizzati b’ xi medikazzjoni antipsikotika (formulazzjoni orali jew depot) jistgħu jaqilbu għal Risperdal Consta mingħajr ebda inkwiet u jinkiseb benefiċċju kliniku simili għal dak li jidher f’ pazjenti li jaqilbu minn risperidone orali u mingħajr inċidenza ogħla ta ’ deterjorament kliniku.
The CHMP agreed that no non-inferiority study is required and the following wording for section 4.1 was adopted:
Is- CHMP qabel li ma huwa meħtieġ ebda studju ta ’ nuqqas ta ’ inferjorità u l- formolazzjoni ta ’ kliem li ġejja ġiet adottata għal sezzjoni 4. 1:
“ Risperdal Consta is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics”.
“ Risperdal Consta huwa indikat għall- kura ta ’ manteniment ta ’ skizofrenija f’ pazjenti li bħalissa huma stabbilizzati b’ antipsikotiċi orali ”.
The CHMP further assessed data from patients switched to Risperdal Consta without stabilisation on oral risperidone, and concluded that sufficient antipsychotic coverage should be ensured during a lag period following the first Risperdal Consta injection.
Is- CHMP kompla jivvaluta iktar tagħrif minn pazjenti li nqelbu għal fuq Risperdal Consta mingħajr stabilizzazzjoni fuq risperidone orali, u kkonkluda li għandha tkun assigurata kopertura antipsikotika suffiċjenti waqt perijodu ta ’ differenza wara l- ewwel injezzjoni ta ’ Risperdal Consta.
The length of the oral supplementation period was also discussed and the CHMP concluded that 3 weeks is the most appropriate length, leading neither to an overdose at the end of the oral supplementation period in those patients who have a relatively early release, nor to clinically relevant ‘ underdosing’ in patients for whom the main release starts from 4 weeks onwards only, given the relatively long half-life of the active moiety following oral risperidone.
It- tul tal - perijodu tas- supplimentazzjoni orali kien ukoll diskuss u s- CHMP ikkonkluda li 3 ġimgħat huwa l - iktar tul addattat, li la jwassal għal teħid eċċessiv fl- aħħar tal- perijodu ta ’ supplimentazzjoni orali f’ dawk il- pazjenti li jkollhom rilaxx relattivament kmieni u lanqas għal ‘ dożaġġ nieqes ’ klinikament relevanti f’ pazjenti li għalihom, ir- rilaxx ewlieni jibda minn 4 ġimgħat ’ l quddiem biss, minħabba l - half- life relattivament twil tal- parti attiva wara risperidone orali.
The need for increased patient monitoring during the switch period was discussed and the CHMP considered that the data provided showed no worsening in clinical symptoms after the therapy with long-acting risperidone was initiated.
Ġiet diskussa l- ħtieġa għal żieda fis- sorveljanza tal- pazjent matul il- perijodu ta ’ bidla u s- CHMP ikkunsidra li t- tagħrif ipprovdut ma wera l- ebda deterjorament fis- sintomi kliniċi wara li nbdiet it - terapija b’ risperidone li jaħdem fit- tul.
According to various treatment guidelines of schizophrenia, the switch of antipsychotic treatment in patients with schizophrenia requires “ per se” the increased
Skond id- diversi linji gwida ta ’ kura ta ’ l- iskiżofrenija, il- qlib tal- kura antipsikotika f’ pazjenti bi skiżofrenija “ per se ” teħtieġ żieda fis- sorveljanza tal- kura minn
15 monitoring of therapy by qualified physicians and the CHMP was therefore of the opinion that due to nature of the illness and long-term experience with treatment of schizophrenia by atypical antipsychotics, proper monitoring of therapy after switching antipsychotic treatment can be expected, without being explicitly mentioned in the SPC.
16 tobba kkwalifikati u s- CHMP kien għalhekk ta ’ l- opinjoni li minħabba n- natura tal- marda u l - esperjenza bil- kura ta ’ skizofrenija b’ antipsikotiċi atipiċi, għandha tkun mistennija sorveljanza xierqa wara l- qlib tal- kura antipsikotika, mingħajr ma din tkun espliċitament imsemmija fl- SPC.
For section 4.2, the CHMP discussed the Risperdal Consta starting dose (25 mg, intramuscular, every 2 weeks), considering the data provided by the MAH, and was of the opinion that the recommendation in the SPC that treatment should be started with the dose of 25 mg every two weeks should be maintained.
Għal sezzjoni 4. 2, is- CHMP iddiskuta d- doża tal- bidu ta ’ Risperdal Consta (25 mg, intramuskolari, kull ġimagħtejn), wara li kkunsidra t- tagħrif ipprovdut mill- MAH, u kien ta ’ l- opinjoni li r - rakkomandazzjoni fl- SPC li l- kura għandha tinbeda b’ doża ta ’ 25 mg kull ġimagħtejn għandha tinżamm.