qanastek/EMEA-V3 huggingface dataset:
Expected adverse events The following adverse reactions are expected under the use of SIFROL: abnormal dreams, amnesia, behavioural symptoms of impulse control disorders and compulsions such as binge eating, compulsive shopping, hypersexuality and pathological gambling; confusion, constipation, delusion, dizziness, dyskinesia, fatigue, hallucinations, headache, hyperkinesia, hyperphagia, hypotension, insomnia, libido disorders, nausea, paranoia, peripheral oedema, pruritus and rash and other hypersensitivity; restlessness, somnolence, sudden onset of sleep, visual disturbance including vision blurred and visual acuity reduced, vomiting, weight decrease, weight increase.
50 Avvenimenti avversi mistennija Ir- reazzjonijiet avversi li ġejjin huma mistennija waqt l- użu ta 'SIFROL: ħolm anormali, amnesija, sintomi ta ’ disturbi fl- imġiba tal- kontroll tal- impulsi u kompulsjonijiet, bħal li wieħed jiekol bl - addoċċ, xiri kompulsiv, ipersesswalità u logħob patoloġiku tal- azzard; konfużjoni, stitikezza, delużjoni, sturdament, diskinesija, għeja kbira, alluċinazzjonijiet, uġigħ ta ’ ras, iperkinesija, iperfaġja, pressjoni tad- demm baxxa, nuqqas ta ’ rqad, disturbi fil- libido, nawseja, paranojja; edema periferali, ħakk, raxx u sensittività eċċessiva oħra; nuqqas ta ’ kwiet f’ ġismek, ngħas, irqad li jiġi għal għarrieda, sinkope, disturb tal- vista li jinkludi vista mċajpra u tnaqqis fiċ- ċarezza tal- vista, rimettar, tnaqqis fil - piż, żieda fil- piż.
Restless Legs Syndrome, most common adverse events The most commonly (≥ 5%) reported adverse drug reactions in patients with Restless Legs Syndrome treated with SIFROL were nausea, headache, dizziness and fatigue.
Sindrome tas- Saqajn Bla Kwiet, l- iktar avvenimenti avversi komuni L- aktar reazzjonijiet avversi (≥ 5%) li kienu rrappurtati b’ mod komuni fil- pazjenti li kellhom is- Sindrome tas- Saqajn Bla Kwiet, ikkurati b’ SIFROL, kienu nawseja, uġigħ ta ’ ras, sturdament u għeja kbira.
Libido disorders SIFROL may be associated with libido disorders (increased (0.1%) or decreased (0.4%)).
52 SIFROL jista ’ jkun assoċjat ma ’ disturbi fil- libido (żieda (0. 1%) jew tnaqqis (0. 4%)).
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
53 tliet snin, ma kien hemm l- ebda sinjali ta ’ tnaqqis fl- effikaċja.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to an hypotensive effect was discerned in the monkey.
54 Tnaqqis fil- pressjoni dijastolika u sistolika u fir- rata ta ’ taħbit tal- qalb kienu nnutati fil- minipig, u kienet osservata tendenza għal effett ipotensiv fix- xadini.
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) Fuq talba tal- EMEA
SIFROL 0.088 mg tablets Pramipexole
SIFROL 0. 088 mg pilloli Pramipexole
SIFROL 0.18 mg tablets Pramipexole
SIFROL 0. 18 mg pilloli Pramipexole
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
SIFROL 0.18 mg
SIFROL 0. 18 mg
- 70 -
70 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SIFROL 0.35 mg tablets Pramipexole
SIFROL 0. 35 mg pilloli Pramipexole
SIFROL 0.35 mg
SIFROL 0. 35 mg
SIFROL 0.7 mg tablets Pramipexole
SIFROL 0. 7 mg pilloli Pramipexole
SIFROL 0.7 mg
SIFROL 0. 7 mg
SIFROL 1.1 mg tablets Pramipexole
SIFROL 1. 1 mg pilloli Pramipexole
SIFROL 1.1 mg
SIFROL 1. 1 mg
SIFROL 0.088 mg tablets pramipexole
SIFROL 0. 088 mg pilloli pramipexole
What SIFROL is and what it is used for 2.
X’ inhu SIFROL u għalxiex jintuża 2.
Before you take SIFROL 3.
Qabel ma tuża SIFROL 3.
How to take SIFROL 4.
Kif tuża SIFROL 4.
How to store SIFROL 6.
Kif taħżen SIFROL 6.
WHAT SIFROL IS AND WHAT IT IS USED FOR
X’ INHU SIFROL U GĦALXIEX JINTUŻA
SIFROL belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
SIFROL jappartjeni għal grupp ta ’ mediċini magħrufa bħala agonisti ta ’ dopamine, li jistimulaw ir- riċetturi ta ’ dopamine fil- moħħ.
SIFROL is used to:
SIFROL jintuża biex:
BEFORE YOU TAKE SIFROL
QABEL MA TUŻA SIFROL
DO NOT take SIFROL
TIĦUX SIFROL
Take special care with SIFROL Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:
Oqgħod attent ħafna b’ SIFROL Għid lit- tabib tiegħek jekk għandek (jew kellek), jew jekk tiżviluppa kwalunkwe kundizzjonijiet jew sintomi mediċi, speċjalment xi waħda minn dawn li ġejjin:
If you have advanced Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of SIFROL.
Jekk għandek marda ta ’ Parkinson li qiegħda fi stadju avvanzat u qed tieħu wkoll levodopa, inti tista ’ tiżviluppa diskinesija matul it- titrazzjoni ’ l fuq ta ’ SIFROL.
- psychosis (e. g. comparable with symptoms of schizophrenia)
- psikosi, (eż. komparabbli ma ’ sintomi ta ’ l- iskiżofrenja)
You should have regular eye examinations during treatment with SIFROL.
Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ SIFROL.
You will need to have your blood pressure checked regularly, especially at the beginning of treatment.
87 Ser ikollok bżonn li jkollok il- pressjoni tad- demm tiegħek iċċekkjata regolarment, speċjalment fil- bidu tal- kura.
This is to avoid postural hypotension (a fall in blood pressure on standing up)
Dan biex tiġi evitata pressjoni tad- demm baxxa ħafna li tiddependi mill- qagħda (il- pressjoni tad- demm titbaxxa malli tqum bilwieqfa).
Children and adolescents SIFROL is not recommended for use in children or adolescents under 18 years.
Tfal u adolexxenti SIFROL mhuwiex rakkomandat għall- użu fit- tfal jew fl- adolexxenti taħt it- 18- il sena.
You should avoid taking SIFROL together with antipsychotic medicines.
Għandek tevita li tieħu SIFROL flimkien ma ’ mediċini antipsikotiċi.
If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with SIFROL.
Jekk qed tieħu levodopa, hu rakkomandat li d- doża ta ’ levodopa titnaqqas meta tibda l- kura b’ SIFROL.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Oqgħod attenta/ a jekk qed tuża kwalunkwe mediċini li jikkalmawk (li għandhom effett sedattiv) jew jekk qed tixrob l- alkoħol.
In these cases SIFROL may affect your ability to drive and operate machinery.
F’ dawn il- każijiet SIFROL jista ’ jaffettwa l- ħila tiegħek li ssuq u tħaddem il- makkinarju.
Taking SIFROL with food and drink You should be cautious while drinking alcohol during treatment with SIFROL.
Meta tieħu SIFROL ma ’ l- ikel u max- xorb Għandek toqgħod attent/ a meta tixrob l- alkoħol matul il- kura b’ SIFROL.
SIFROL can be taken with or without food.
SIFROL jista ’ jittieħed ma ’ l- ikel jew mingħajr l- ikel.
Your doctor will then discuss with you if you should continue to take SIFROL.
It- tabib tiegħek imbagħad ser jiddiskuti miegħek jekk għandekx tkompli tieħu SIFROL.
The effect of SIFROL on the unborn child is not known.
L- effett ta ’ SIFROL fuq it- tarbija mhix imwielda mhuwiex magħruf.
Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so.
Għalhekk, tiħux SIFROL jekk inti tqila ħlief jekk it- tabib tiegħek jgħidlek biex tagħmel hekk.
SIFROL should not be used during breast-feeding.
SIFROL m’ għandux jintuża waqt it- treddigħ. SIFROL jista ’ jnaqqas il- produzzjoni tal- ħalib tas- sider.
If use of SIFROL is unavoidable, breast-feeding should be stopped.
Jekk l- użu ta ’ SIFROL ma jkunx jista ’ jiġi evitat, it- treddigħ għandu jitwaqqaf.
Driving and using machines SIFROL can cause hallucinations (seeing, hearing or feeling things that are not there).
Sewqan u tħaddim ta ’ magni SIFROL jista ’ jikkawża alluċinazzjonijiet (tara, tisma ’ jew tħoss affarijiet li ma jkunux hemm).
SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson’ s disease.
SIFROL kien assoċjat ma ’ rqad u ma ’ episodji ta ’ rqad li jiġi f’ daqqa, partikularment f’ pazjenti bil- marda ta ’ Parkinson.
Important information about some of the ingredients of SIFROL tablets SIFROL tablets contain mannitol.
Tagħrif importanti dwar xi wħud mis- sustanzi tal- pilloli SIFROL Il- pilloli SIFROL fihom il- mannitol.
HOW TO TAKE SIFROL
KIF TUŻA SIFROL
Always take SIFROL exactly as your doctor has told you.
Dejjem għandek tieħu SIFROL skond il- parir tat- tabib.
You can take SIFROL with or without food.
Tista 'tieħu SIFROL ma' l- ikel jew mingħajr l- ikel.
Swallow the tablets with water.
Ibla 'l- pilloli ma' l- ilma.
1st week
Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg tliet darbiet kuljum (ekwivalenti għal 0. 264 mg kuljum):
1 tablet SIFROL 0.088 mg three times a day
1 pillola SIFROL 0. 088 mg tliet darbiet kuljum
3rd week
SIFROL 0. 088 mg tliet darbiet kuljum
1 tablet SIFROL 0.35 mg three times a day OR 2 tablets SIFROL 0.18 mg three times a day
2 pilloli SIFROL 0. 18 mg tliet darbiet kuljum
A lower maintenance dose of three SIFROL 0.088 mg tablets a day is also possible.
Doża tal- manteniment iktar baxxa ta ’ tliet pilloli SIFROL 0. 088 mg kuljum hi wkoll possibbli.
1 tablet SIFROL 0.088 mg three times a day
1 pillola SIFROL 088 mg tliet darbiet kuljum
1 tablet SIFROL 1.1 mg three times a day
pillola SIFROL 1. 1 mg tliet darbiet kuljum
If you have moderate kidney disease, the usual starting dose is 1 tablet SIFROL 0.088 mg twice a day.
Jekk għandek mard moderat, id- doża normali tal- bidu hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darbtejn kuljum.
In severe kidney disease, the usual starting dose is just 1 tablet SIFROL 0.088 mg a day.
F’ mard sever tal- kliewi, id- doża normali tal- bidu hi ta ’ pillola waħda biss ta ’ SIFROL 0. 088 mg kuljum.
During the first week, the usual dose is 1 tablet SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily):
Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
- 89 -
89 1el ġimgħa
1st week
1 pillola SIFROL 088 mg
Number of tablets
Doża totali ta ’ kuljum (mg)
1 tablet SIFROL 0.088 mg
0. 088
1 tablet SIFROL 0.18 mg OR
1 pillola SIFROL 0. 18 mg JEW
1 tablet SIFROL 0.35 mg OR
1 pillola SIFROL 0. 35 mg JEW
2 tablets SIFROL 0.088 mg
1 pillola SIFROL 0. 35 mg u 1 pillola SIFROL 0. 18 mg
4 tablets SIFROL 0.088 mg
2 pilloli SIFROL 0. 088 mg
SIFROL 0.18 mg OR
2 pilloli SIFROL 0. 18 mg JEW 4 pilloli SIFROL 0. 088 mg
6 tablets SIFROL 0.088 mg Total
JEW 3 pilloli SIFROL 0. 18 mg JEW 6 pilloli SIFROL 0. 088 mg
The daily dose should not exceed 6 tablets SIFROL 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Id- doża ta ’ kuljum m’ għandhiex taqbeż 6 pilloli SIFROL 0. 088 mg jew doża ta ’ 0. 54 mg (0. 75 mg ta ’ melħ ta ’ pramipexole).
If you have severe kidney disease, SIFROL may not be a suitable treatment for you.
Jekk għandek mard sever tal- kliewi, SIFROL jista ’ ma jkunx kura adattata għalik.
If you take more SIFROL than you should If you accidentally take too many tablets,
Jekk tieħu SIFROL aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda
- contact your doctor or nearest hospital casualty department immediately for advice.
- ikkuntattja lit- tabib tiegħek jew lill- eqreb dipartiment ta ’ l- emerġenza immedjament għal parir.
- you may experience vomiting, restlessness, or any of the side effects as described in chapter 4
- jista ’ jkollok rimettar, nuqqas ta ’ kwiet f’ ġismek, jew kwalunkwe mill- effetti sekondarji deskritti
(Possible side effects).
f’ Kapitlu 4 (Effetti sekondarji li jista ’ jkollu)
If you forget to take SIFROL Do not worry.
Jekk tinsa tieħu SIFROL Tinkwetax.
If you stop taking SIFROL Do not stop taking SIFROL without first talking to your doctor.
Jekk tieqaf tieħu SIFROL Tiqafx tieħu SIFROL mingħajr ma l- ewwel titkellem mat- tabib tiegħek.
If you suffer from Parkinson’ s disease you should not stop treatment with SIFROL abruptly.
Jekk tbati mill- marda ta ’ Parkinson, m’ għandekx twaqqaf il- kura b’ SIFROL f’ daqqa.
Like all medicines, SIFROL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SIFROL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you suffer from Parkinson’ s disease, you may experience the following side effects:
Jekk tbati mill- Marda ta ’ Parkinson jista ’ jkollok dawn l- effetti sekondarji:
- Hypersexuality
- Logħob patoloġiku tal- azzard, speċjalment meta tieħu dożi qawwija ta ’ SIFROL
- Compulsive shopping
- Ipersesswalità
- Pathological gambling, especially when taking high doses of SIFROL
- Logħob patoloġiku ta ’ l- azzard, speċjalment meta tieħu dożi qawwija ta ’ SIFROL
HOW TO STORE SIFROL
KIF TAĦŻEN SIFROL
Do not take SIFROL after the expiry date, which is stated on the pack.
Tużax SIFROL wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Do not store above 30°C.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
- 92 -
92 Taħżinx f’ temperatura ’ l fuq minn 30°C.
What SIFROL contains The active substance is pramipexole.
X’ fih SIFROL Is- sustanza attiva hi pramipexole.
Each SIFROL 0.088 mg tablet contains 0.088 mg of pramipexole base (as 0.125 mg of pramipexole dihydrochloride monohydrate).
Kull pillola SIFROL ta ’ 0. 088 mg fiha 0. 088 mg ta ’ bażi ta ’ pramipexole (bħala 0. 125 mg ta ’ pramipexole dihydrochloride monohydrate).
What SIFROl looks like and contents of the pack SIFROL 0.088 mg tablets are white, round, flat, embossed with a code, without scoring.
Id- dehra ta ’ SIFROL u l- kontenuti tal- pakkett Il- pilloli SIFROL 0. 88 mg huma bojod, tondi, ċatti u mnaqqxa b’ kodiċi, mingħajr ferq.
SIFROL is available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
SIFROL hu disponibbli fi strixxi bil- folji ta ’ l- aluminju ta ’ 10 pilloli f’ kull strixxa, f’ kaxxi tal- kartun li fihom 3 jew 10 strixxi bil- folji (30 jew 100 pillola).
This leaflet was last approved on {date}
Din fuljett kienet approvat l- aħħar fi {data}
SIFROL 0.18 mg tablets pramipexole
SIFROL 0. 18 mg pilloli pramipexole
- kidney disease.
- mard tal- kliewi.
- 96 -
96 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ SIFROL.
1st week
Jekk għandek mard moderat, id- doża normali tal- bidu hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darbtejn kuljum.
2nd week
F’ mard sever tal- kliewi, id- doża normali tal- bidu hi ta ’ pillola waħda biss ta ’ SIFROL 0. 088 mg kuljum.
3rd week
98 Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
4th week
1el ġimgħa
Number of
Numru ta ’ pilloli
1 tablet SIFROL 0.18 mg
1 pillola SIFROL 088 mg
1 tablet SIFROL 0.35 mg
Doża totali ta ’ kuljum (mg)
1 tablet SIFROL
0. 088
tablets
2ni ġimgħa
OR OR
3et ġimgħa
0.35 mg and 1 tablet
4ba ġimgħa
2 tablets SIFROL 0.088 mg
Numru ta ’ pilloli
2 tablets SIFROL 0.18 mg OR
1 pillola SIFROL 0. 18 mg JEW
SIFROL
1 pillola SIFROL 0. 35 mg JEW
0.18 mg OR
1 pillola SIFROL 0. 35 mg u 1 pillola SIFROL 0. 18 mg
4 tablets
2 pilloli SIFROL 0. 088 mg
SIFROL 0.088 mg
2 pilloli SIFROL 0. 18 mg JEW 4 pilloli SIFROL 0. 088 mg
3 tablets SIFROL 0.18 mg OR 6 tablets SIFROL 0.088 mg
JEW 3 pilloli SIFROL 0. 18 mg JEW 6 pilloli SIFROL 0. 088 mg
(Possible side effects).
deskritti f’ Kapitlu 4 (Effetti sekondarji li jista ’ jkollu)
These symptoms include:
Is- sintomi jinkludu:
- unstable blood pressure
- muskoli iebsin
If you suffer from Parkinson’ s disease, you may experience the following side effects:
Jekk tbati mill- Marda ta ’ Parkinson, jista ’ jkollok dawn l- effetti sekondarji:
Very common:
(Komuni ħafna:
- Hypersexuality
- Iħossok ħażin
Do not take SIFROL after the expiry date, which is stated on the pack.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
- 101 -
101 Tużax SIFROL wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Store in the original package to protect the tablets from light.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
Each SIFROL 0.18 mg tablet contains 0.18 mg of pramipexole base (as 0.25 mg of pramipexole dihydrochloride monohydrate).
Kull pillola SIFROL 0. 18 mg fiha 0. 18 mg ta ’ bażi ta ’ pramipexole (bħala 0. 25 mg of pramipexole dihydrochloride monohydrat).
What SIFROL looks like and contents of the pack SIFROL 0.18 mg tablets are white, oval, flat, embossed with a code.
Id- dehra ta ’ SIFROL u l- kontenuti tal- pakkett Il- pilloli SIFROL 0. 18 mg huma bojod, ovali, ċatti u mnaqqxa b’ kodiċi.
SIFROL 0.35 mg tablets pramipexole
SIFROL 0. 35 mg pilloli pramipexole
3rd week
107 Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
If you take more SIFROL than you should If you accidentally take too many tablets
Jekk tieħu SIFROL aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda
(Possible side effects)
deskritti f’ Kapitlu 4 (Effetti sekondarji li jista ’ jkollu)
- 110 -
110 Tużax SIFROL wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Each SIFROL 0.35 mg tablet contains 0.35 mg of pramipexole base (as 0.5 mg of pramipexole dihydrochloride monohydrate).
Kull pillola SIFROL 0. 35 mg fiha 0. 35 mg ta ’ bażi ta ’ pramipexole (bħala 0. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
What SIFROL looks like and contents of the pack SIFROL 0.35 mg tablets are white, oval, flat, embossed with a code.
Id- dehra ta ’ SIFROL u l- kontenuti tal- pakkett Il- pilloli SIFROL 0. 35 mg huma bojod, ovali, ċatti u mnaqqxa b’ kodiċi.
SIFROL 0.7 mg tablets pramipexole
SIFROL 0. 7 mg pilloli pramipexole
SIFROL belongs to a group of medicines known as dopamine agonists, which stimulate dopamine receptors in the brain.
SIFROL. jappartjeni għal grupp ta ’ mediċini magħrufa bħala agonisti ta ’ dopamine, li jistimulaw ir- riċetturi ta ’ dopamine fil- moħħ.
If you have advanced Parkinson’ s disease and are also taking levodopa, you might develop dyskinesia during the uptitration of SIFROL.
Jekk għandek marda ta ’ Parkinson li qiegħda fi stadju avvanzat u qed tieħu wkoll levodopa, inti tista ’ tiżviluppa d- diskinesija matul it- titrazzjoni ’ l fuq ta ’ SIFROL.
- 114 -
114 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ SIFROL.
3rd week
116 Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
- Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
- Tibdil fir- rittmu ta ’ l- irqad, bħal problemi biex torqod (insomnja) u ngħas Għeja
- 119 -
119 Tużax SIFROL wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Each SIFROL 0.7 mg tablet contains 0.7 mg of pramipexole base (as 1 mg of pramipexole dihydrochloride monohydrate).
Kull pillola SIFROL 0. 7 mg fiha 0. 7 mg ta ’ bażi ta ’ pramipexole (bħala 1 mg ta ’ pramipexole dihydrochloride monohydrate).
What SIFROL looks like and contents of the pack SIFROL 0.7 mg tablets are white, round, flat, embossed with a code.
Id- dehra ta ’ SIFROL u l- kontenuti tal- pakkett Il- pilloli SIFROL 0. 7 mg huma bojod, ovali, ċatti u mnaqqxa b’ kodiċi.
SIFROL 1.1 mg tablets pramipexole
SIFROL 1. 1 mg pilloli pramipexole
- 123 -
123 Għandhom isirulek eżamijiet regolari ta ’ l- għajnejn eżamijiet matul il- kura b’ SIFROL.
3rd week
125 Matul l- ewwel ġimgħa, id- doża normali hi ta ’ pillola waħda ta ’ SIFROL 0. 088 mg darba kuljum (ekwivalenti għal 0. 088 mg kuljum):
(Possible side effects)..
deskritti f’ Kapitlu 4 (Effetti sekondarji li jista ’ jkollu)
If you suffer from Parkinson’ s disease you should not stop treatment with SIFROL abruptlyA sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk.
It- twaqqif f’ daqqa jista ’ jkun il- kawża li tiżviluppa kundizzjoni medika msejħa sindrome malinn newroleptiku li jista ’ jirrappreżenta riskju maġġuri għas- saħħa.
- Pathological gambling, especially when taking high doses of SIFROL
- Logħob patoloġiku ta ’ l- azzard, speċjalment meta tieħu dożi qawwija ta’ SIFROL
- 128 -
128 Tużax SIFROL wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Each SIFROL 1.1 mg tablet contains 1.1 mg of pramipexole base (as 1.5 mg of pramipexole dihydrochloride monohydrate).
Kull pillola SIFROL 1. 1 mg fiha 1. 1 mg ta ’ bażi ta ’ pramipexole base (bħala 1. 5 mg ta ’ pramipexole dihydrochloride monohydrate).
What SIFROL looks like and contents of the pack SIFROL 1.1 mg tablets are white, round, flat, embossed with a code.
Id- dehra ta ’ SIFROL u l- kontenuti tal- pakkett Il- pilloli SIFROL 1. 1 mg huma bojod, ovali, ċatti u mnaqqxa b’ kodiċi.
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Siklos?
X' inhu Siklos?
Siklos is a medicine containing the active substance hydroxycarbamide.
Siklos hu mediċina li fiha s- sustanza attiva hydroxycarbamide.
It is available as tablets (1,000 mg).
Huwa disponibbli f’ forma ta ’ pilloli (1, 000 mg).
What is Siklos used for?
Għal x' hiex jintuża Siklos?
Siklos is used in adults and in children who have sickle cell syndrome (a genetic disease where the red blood cells change shape and become inflexible when they are not carrying oxygen).
Siklos jintuża f' adulti u tfal li jkollhom sickle cell syndrome (marda ġenetika li fiha, iċ- ċelloli tad - demm jibdlu l- għamla tagħhom u jtilfju l- flessibbilità tagħhom meta ma jkunux qed iġorru l- ossiġenu).
It is used to prevent painful vaso-occlusive crises that are recurrent (keep coming back).
Jintuża biex jipprevjeni kriżijiet vaso- okklussivi rikorrenti li jikkawżaw uġigħ kbir (li jseħħu b’ mod ripetittiv).
Vaso-occlusive crises happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ.
Il- kriżijiet vaso- okklusivi jseħħu meta l- arterji u l- vini jinstaddu minn ċelloli tad- demm ħomor anormali, u b' hekk inaqqsu ix- xnigħa tad- demm lejn xi organu.
They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X-ray.
Jistgħu jinkludu s- sindromu perikoluż li fih, il- pazjent ikollu uġigħ immedjat f' sidru, deni, tbatija fin- nifs jew sinjali ta 'fluwidu fil - pulmun fir- raġġi X.
The medicine can only be obtained with a prescription.
Billi l- għadd ta 'pazjenti li għandhom sickle cell syndrome huwa wieħed baxx, il- marda hi meqjusa' rari 'u Siklos ġie propost bħala' mediċina orfni '(mediċina użata fil- mardiet rari) fid- 9 ta' Lulju ta 'l - 2003 Il- mediċina tista' tinkiseb biss b' riċetta ta 'tabib.
How is Siklos used?
Kif jintuża Siklos?
Treatment with Siklos should be initiated by a doctor who has experience in the management of sickle cell syndrome.
It- trattament b' Siklos għandu jiġi preskritt minn tabib li jkollu esperjenza fil- ġestjoni tas- sickle cell syndrome.
Siklos is taken once a day, preferably in the morning before breakfast.
Siklos jittieħed darba kuljum, preferibbilment filgħodu qabel il- kolazzjon.
The starting dose is usually 15 mg per kilogram body weight, to the nearest 250 mg (quarter tablet).
Id- doża inizjali ġeneralment tkun 15- il mg għal kull kilogramma li jiżen il- pazjent, sa l- eqreb 250 mg (kwart ta 'pillola).
The tablet has special score lines so that it can be easily divided into four equal parts.
Il- pillola għandha linji tal- qsim apposta biex tkun tista 'tinqasam faċilment f' erba' biċċiet indaqs.
The dose is adjusted according to response to treatment, with the usual dose being between 15 and 30 mg per kilogram body weight per day.
Id- doża tiġi aġġustata skond ir- rispons għat- trattament, bid- doża normali tkun bejn 15 u 30 mg għal kull kilogramma li jiżen il- pazjent.
Doses of up to 35 mg per kilogram body weight per day can be used in exceptional cases, as long as the patient ’ s blood is monitored for side effects.
Dożi sa 35 mg għal kull kilo li jiżen il- pazjent kuljum jistgħu jintużaw f' każijiet eċċezzjonali, sakemm id- demm tal- pazjent jiġi sorveljat għall- effetti sekondarji.
Patients who do not respond to this dose or who have side effects may need to stop or suspend treatment.
Il- pazjenti li ma jirrispondux għal din id- doża jew li jkollhom effetti sekondarji jista 'jkollhom iwaqqfu jew jissospendu t- trattament.
The dose of Siklos should be reduced in patients who have mild or moderate problems with their kidneys, and it should not be used in patients with severe problems with their kidneys or liver.
Id- doża ta 'Siklos għandha titnaqqas f' pazjenti li jkollhom problemi ħfief jew moderati fil- kliewi, u m' għandhiex tintuża minn pazjenti bi problemi severi fil- kliewi jew fil- fwied.
Siklos is not recommended for children aged below 2 years.
Siklos mhux rakkomandat għal tfal ta 'inqas minn sentejn.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged red blood cells changing shape in patients with sickle cell syndrome.
Is- sustanza attiva f' Siklos, hydroxycarbamide, tinibixxi l- kobor u r- riproduzzjoni ta 'xi ċelloli bħaċ - ċelloli tad- demm.
This reduces the risk of blood vessels becoming blocked.
Dan inaqqas ir- riskju li jinstaddu l- arterji u l- vini tad- demm.
Hydroxycarbamide, which used to be known as hydroxyurea, has been available in the European Union (EU) for several decades for use in other illnesses, including some types of cancer.
Hydroxycarbamide, li qabel kien magħruf bħala hydroxyurea, ilu disponibbli fl- Unjoni Ewropea (UE) għal diversi għexieren ta ’ snin sabiex jintuża għal mardiet oħra, inkluż xi tipi ta 'kankru.
How has Siklos been studied?
Kif ġie studjat Siklos?
Because hydroxycarbamide is a well-known substance that is already used in other medicines, the company used data from the scientific literature to support the use of Siklos in adults and children with sickle cell syndrome.
Billi hydroxycarbamide hu sustanza magħrufa li tintuża diġà f' mediċini oħra, il- kumpanija użat it - tagħrif mil- letteratura xjentifika biex tappoġġja l- użu ta 'Siklos fl- adulti u t- tfal bis- sickle cell síndrome.
In particular, it presented evidence on the effectiveness of Siklos from 11 published studies involving 378 children and from three national registries of information on 155 children who were treated with Siklos for up to 7 years.
B' mod partikolari, il- kumpanija ppreżentat evidenza dwar l- effettività ta 'Siklos minn 11- il studju ppubblikat li fihom ħadu sehem 378 tifel u tifla u minn tliet reġistri nazzjonali ta' tagħrif fuq 155 tifel u tifla b' sickle cell syndrome li kienu ttrattati b' Siklos għal mhux iktar minn seba 'snin.
It also presented evidence from one study in 299 adults, in which the effects of Siklos were compared with those of placebo (a dummy treatment), as well as the results of other studies involving 430 adults and one national registry of information on 123 adults treated with Siklos.
Ġiet murija wkoll evidenza fi studju fuq 299 adulti fejn l- effetti tas- Siklos ġew paragunati ma ’ dak tal - placebo (trattament finta), kif ukoll mar- riżultati ta ’ studji oħrajn li kienu jinvolvu 430 adult u reġistru ta ’ l- informazzjoni nazzjonali wieħed rigward 123 adult li ġew trattati bis- Siklos.
The studies compared the number of vaso-occlusive crises before and after treatment with Siklos, as defined by any painful episode involving the arms, legs, abdomen (tummy), back or chest.
L- istudji qabblu n - numru ta 'kriżijiet vaso- okklusivi qabel u wara t- trattament b' Siklos, liema kriżijiet jiġu definiti bħala episodju ta' uġigħ fid- dirgħajn, fis- saqajn, fiż- żaqq, fid- dahar u fis- sider.
What benefit has Siklos shown during the studies?
X' benefiċċji ta 'Siklos intwerew f' dawn l- istudji?
Patients treated with Siklos had fewer vaso-occlusive crises after treatment with Siklos than before treatment, with the frequency falling by between 66% and 80% in children and adults.
Il- pazjenti ttrattati b' Siklos kellhom inqas kriżijiet vaso- okklusivi wara t- trattament b' Siklos milli qabel it- trattament, bil- frekwenza taqa 'b' bejn 66% u 80% fit- tfal u l- adulti.
The frequency of cases of acute chest syndrome also fell by 25 to 33%.
Il- frekwenza tal- każijiet tas - sindromu akut tal- pulmun ukoll naqset b' bejn 25 u 33%.
There were also fewer admissions into hospital, and fewer days spent in hospital.
Kien hemm ukoll inqas pazjenti li kellhom bżonn jiddaħħlu l- isptar, u inqas jiem imqattgħin l- isptar.
The effects were sustained for up to 7 years.
L- effetti nżammu sa mhux aktar minn 7 snin.
In the study comparing Siklos to placebo in adults, there were fewer vaso-occlusive crises in the patients taking Siklos (2.5 crises per year) than in those taking placebo (4.5 crises per year).
Fil- paragun li sar f’ dan l- istudju bejn Siklos u l- placebo, kien hemm anqas kriżijiet vaskokklużivi fil- pazjenti li jieħdu s- Siklos (2. 5 kriżijiet fis- sena) milli f’ dawk li jieħdu l- placebo (4. 5 kriżijiet fis - sena).
What is the risk associated with Siklos?
X' inhu r- riskju assoċjat ma 'Siklos?
The most common side effect with Siklos (seen in more than 1 patient in 10) is bone marrow suppression, causing neutropenia (low levels of neutrophils, a type of white blood cell), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and macrocytosis (enlargement of red blood cells).
L- iktar effett sekondarju komuni tat- teħid ta 'Siklos (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu s- sopressjoni tal- mudullun tal- għadam, li jwassal għal newtropenja (livelli baxxi ta' neutrophils, tip ta 'ċelloli tad- demm bojod), reticulocytopenia (livelli baxxi ta' reticulocytes, tip ta 'ċelloli tad- demm ħomor immaturi) u macrocytosis (tkabbir taċ- ċelloli ħomor tad- demm).
Patients taking Siklos should have blood tests before and regularly during treatment, to check blood cell counts and also to monitor their kidneys and liver.
Il- pazjenti li jkunu qed jieħdu Siklos għandhom jieħdu testijiet tad- demm qabel u regolarment waqt it- trattament, biex jiċċekkjaw l- għadd taċ- ċelloli tad- demm u wkoll jissorveljaw il- kliewi u l- fwied.
Blood cell counts normally return to normal within two weeks of stopping Siklos treatment.
L- għadd ta 'ċelloli tad- demm normalment jerġa' lura għan- normal sa ġimagħtejn wara li jkun twaqqaf it- trattament b' Siklos.
For the full list of all side effects reported with Siklos, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji rrappurtati ma' Siklos, ara l- Fuljett ta 'Tagħrif.
Siklos should not be used in people who may be hypersensitive (allergic) to hydroxycarbamide or any of the other ingredients.
Siklos m' għandux jintuża minn persuni li jkunu sensittivi żżejjed (allerġiċi) għal hydroxycarbamide jew għal xi sustanza oħra tiegħu.
It should also not be used by people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts.
Lanqas m' għandu jintuża minn persuni li jkollhom problemi severi bil- kliewi jew fil- fwied, jew li jkollhom l- għadd ta 'ċelloli tad- demm ħomor perikolożament baxx.
Breast-feeding should be stopped while taking Siklos.
It - treddigħ għandu jitwaqqaf waqt it- teħid ta 'Siklos.
Why has Siklos been approved?
Għaliex ġie approvat Siklos?
The Committee for Medicinal Products for Human Use (CHMP) decided that Siklos’ s benefits are greater than its risks for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle cell syndrome.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Siklos għandu iktar benefiċċji milli riskji fil- prevenzjoni ta 'kriżijiet vaso- oklussivi rikurrenti inkluż is- sindromu akut tal- pulmun f' pazjenti adulti u tfal li jkollhom sickle cell syndrome simtomatika.
The Committee recommended that Siklos be given marketing authorisation.
Il- Kumitat irrakkomanda li Siklos jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Siklos?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sikur ta ’ Siklos?
The company that makes Siklos will provide information packs for doctors and for patients describing the safety information on the medicine.
Il- kumpanija li tagħmel Siklos se tipprovdi pakketti ta 'tagħrif għat- tobba u għall- pazjenti li jiddeskrivu t- tagħrif dwar is- sigurtà ta' din il- mediċina.
Other information about Siklos:
Tagħrif ieħor dwar Siklos:
The European Commission granted a marketing authorisation valid throughout the EU for Siklos to Addmedica on 29 June 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Siklos, valida fl- Unjoni Ewropea kollha, lil Addmedica fid- 29 ta ’ Ġunju 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Siklos is available here.
Is- sommarju ta 'l- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal Siklos jista' jinstab hawn.
The full EPAR for Siklos can be found here.
L- EPAR sħiħ għal Siklos jista 'jinstab hawn.
This summary was last updated in 07-2007.
Dan is- sommarju ġie aġġornat f’ 07- 2007.
EU Number EU/ 1/ 07/ 397/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 397/ 001
Invented name Siklos
Isem inventat Siklos
Strength 1000 mg
Qawwa 1000 mg
Pharmaceutical Form Film-coated tablet
Għamla farmaċewtika Pillola miksija b' rita
Route of Administration Oral use
Mnejn jingħata Użu orali
Packaging blister (PVC/ PVDC/ alu)
Il- pakkett Folja (PVC/ PVDC- aluminju)
Package size 30 film-coated tablets
Daqs tal- pakkett 30 pillola miksija b’ rita
Siklos 1000 mg film-coated tablets.
Siklos 1000 mg pilloli miksija b’ rita.
Each tablet contains 1000 mg of hydroxycarbamide.
Kull pillola fiha 1000 mg ta ’ hydroxycarbamide.
Film-coated tablet (tablet)
Pillola miksija b’ rita (pillola).
An off-white, capsule-shaped, film-coated tablet with triple scoring on both sides.
Pillola miksija b’ rita, ta ’ kulur abjad maħmuġ, forma ta ’ kapsula u mnaqqxha bi tliet linji fuq iż- żewġ naħat biex tkun tista taqsamha f’ erba biċċiet indaqs.
(see section 5.1)
Siklos huwa indikat għall- prevenzjoni ta ’ kriżijiet rikorrenti vaso- okklussivi bl- uġigħ inkluż is - sindromu akut tas- sider f’ pazjenti tfal u adulti li jsofru mis- Sindromu Sickle Cell sintomatiku (ara sezzjoni 5. 1).
Treatment with Siklos should be initiated by a physician experienced in the management of Sickle Cell Syndrome.
Kura b’ Siklos trid tinbeda minn tabib b’ esperjenza fl- immaniġġjar tas- Sindromu Sickle Cell.
Posology In adults, adolescents and children older than 2 years:
Pożoloġija Fl- adulti, adolexxenti u tfal akbar minn sentejn:
The posology should be based on the patient’ s body weight (b. w.).
Il- pożoloġija trid tiġi bbażata fuq il- piż tal- ġisem tal- pazjent (b. w.).
The starting dose of hydroxycarbamide is 15 mg/ kg b. w. and the usual dose is between 15 and 30 mg/ kg b. w. / day.
Id- doża tal- bidu ta ’ hydroxycarbamide hija ta ’ 15 mg/ kg piż tal- ġisem u d- doża tas- soltu hija bejn 15 u 30 mg/ kg piż tal- ġisem / kuljum.
Under exceptional circumstances a maximum dose of 35 mg/ kg b. w. / day might be justified under close haematological monitoring (see section 4.4).
Taħt ċirkostanzi eċċezzjonali biss tista ’ tiġi iġġustifikata doża massima ta ’ 35 mg/ kg piż tal- ġisem / kuljum b’ sorveljanza ematoloġika mil- viċin (ara sezzjoni 4. 4).
The dosage of Siklos can be adjusted to body weight by increments of 250 mg by using a quarter of a tablet.
Id- dożaġġ ta ’ Siklos jista ’ jiġi aġġustat għall- piż tal- ġisem b’ żidiet ta ’ 250 mg billi tuża kwart ta ’ pillola.
As long as the patient responds to therapy either clinically or haematologically (e. g. increase of haemoglobin F (HbF), Mean Corpuscular Volume (MCV), neutrophil count) the dose of Siklos should be maintained.
Sakemm il- pazjent jirrispondi klinikament jew ematoloġikament għall- kura (e. ż. żieda fl- emoglobina F (HbF), Mean Corpuscular Volume (MCV), għadd ta ’ newtrofili) id- doża ta ’ Siklos għandha tinżamm.
In case of non-response (re-occurrence of crises or no decrease in crisis rate) the daily dose may be increased by 250 mg steps.
F’ każ ta ’ nuqqas ta ’ rispons (jerġu jseħħu l- kriżijiet jew l- ebda nuqqas fir- rata ’ ta ’ kriżi) id- doża ta ’ kuljum tista ’ tiġi miżjuda bi qwantitajiet ta ’ 250 mg kull darba.
In the event a patient does still not respond when treated with the maximum dose of hydroxycarbamide (35 mg/ kg b. w. / day) over three to six months, permanent discontinuation of Siklos should be considered.
F’ każ li l- pazjent xorta ma rrispondiex meta kkurat bl- għola doża ta ’ hydroxycarbamide (35 mg/ kg piż tal- ġisem / kuljum) fuq perjodu ta ’ bejn tliet sa sitt xhur, trid tiġi kkunsidrata l- waqfien permanenti ta ’ Siklos.
If blood counts are within the toxic range Siklos should be temporarily discontinued until blood counts recover.
Jekk l- għadd tad- demm huma ġol- limitu tossiku, Siklos irid jiġi mwaqqaf temporanjament sakemm l - għadd tad- demm jirkupra.
Haematologic recovery usually occurs within two weeks.
Rkupru ematoloġiku normalment iseħħ f’ ġimgħatejn.
Treatment may then be reinstituted
L- kura tista ’ mbagħad terġa tinbeda b’ doża mnaqqsa.
The dose of Siklos may then be increased again under close haematological monitoring.
Id- doża ta ’ Siklos tista ’ terġa tiġi miżjuda taħt sorvejanza ematoloġika mil- qrib.
A dose producing haematological toxicity should not be tried more than two times.
Doża li twassal għall- tossiċità ematoloġika ma tridx tiġi wżata aktar minn darbtejn.
The toxic range may be characterised by the following results of blood tests:
Il- limitu tossiku jista ’ jiġi kkaratterizzat mir- riżultati tat- testijiet tad- demm li ġejjin: < 2000 / mm3 Newtrofili < 80, 000 / mm3 Plejtlets 2
Neutrophils Platelets Haemoglobin Reticulocytes
Emoglobina Retikuloċiti
< 2000 / mm3 < 80,000/ mm3 < 4.5 g/ dl < 80,000/ mm3 if the haemoglobin concentration < 9 g/ dl
< 4. 5 g/ dl < 80, 000 / mm3 jekk il- konċentrazzjoni ta ’ l- emoglobina tkun < 9 g/ dl
Long-term data on the continued use of hydroxycarbamide in patients with Sickle Cell Syndrome are available in children and adolescents, with a follow-up of 12 years in adolescents and over 13 years in adults.
Informazzjoni fuq perjodu twil fuq l- użu kontinwu ta ’ hydroxycarbamide f’ pazjenti bis- Sindromu Sickle Cell hija disponibbli għat- tfal u adolexxenti, b’ sorveljanza ta ’ 12- il sena fl- adolexxenti u aktar minn 13- il sena fl- adulti.
It is currently unknown how long patients should be treated with Siklos.
Sa issa għadu mhux magħruf għal kemm żmien il- pazjenti għandhom jiġu kkurati b’ Siklos.
The duration of treatment is the responsibility of the treating physician and should be based on the clinical and haematological status of the individual patient.
It- tul tal- kura hija r- responsabiltà tat- tabib li qed jikkura u għandha tkun ibbażata fuq il- qagħda klinika u ematoloġika ta ’ kull pazjent individwali.
Children less than 2 years of age Because of the rarity of data on treatment with hydroxycarbamide in children less than 2 years of age, dosage regimens have not been established and thus, in this population, the treatment with hydroxycarbamide is not recommended.
Tfal taħt l- età ta ’ sentejn Minħabba li informazzjoni dwar kura b’ hydroxycarbamide fit- tfal taħt is- sentejn hija rari, dożaġġi għadhom ma ġewx stabbiliti u għalhekk, f’ din il- popolazzjoni, l- kura b’ hydroxycarbamide mhix rakkomandata.
Children and adolescents (2-18 years old) In children and adolescents with Sickle Cell Syndrome, systemic exposure to hydroxycarbamide is similar to adult patients.
Tfal u adolexxenti (2- 18- il sena) Fit- tfal u adolexxenti bis- Sindromu Sickle Cell, l- użu ta ’ hydroxycarbamide huwa simili bħal f’ pazjenti adulti.
Hence, no dose-adjustments are necessary in younger patients.
Għalhekk, m’ hemmx bżonn aġġustament tad- doża f’ pazjenti iżgħar.
As renal excretion is a main pathway of elimination, dosage reduction of Siklos should be considered in patients with renal impairment.
Indeboliment renali Minħabba li l- eskrezzjoni renali hija l- meżż prinċipali għall- eliminazzjoni, tnaqqis fid- doża ta ’ Siklos għandha tiġi kkunsidrata f’ pazjenti b’ indeboliment renali.
In patients with a creatinine clearance ≤ 60 ml/ min the initial Siklos dose should be decreased by 50%.
F’ pazjenti b’ eliminazzjoni tal- krejatinina ≤ 60 ml/ min, id- doża tal- bidu ta ’ Siklos trid tiġi mnaqqsa b’ 50%.
Close monitoring of haematologic parameters is advised in these patients.
Sorveljanza mill- qrib tal- parametri ematoloġiċi hija rakkomandata f’ dawn il- pazjenti.
Siklos should not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see sections 4.3, 4.4 and 5.2).
Siklos m’ għandux jingħata lill- pazjenti b’ indeboliment renali serju (eliminazzjoni tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3, 4. 4 u 5. 2).
There are no data that support specific dosage adjustments in patients with hepatic impairment.
Indeboliment tal- fwied M’ hemmx informazzjoni li ssostni aġġustament fid- dożaġġ speċifiku f’ pazjenti b’ indeboliment tal - fwied.
Close monitoring of haematologic parameters is advised in these patients.
Sorveljanza mil- qrib tal- parametri ematoloġiċi hija rakkomandata f’ dawn il- pazjenti.
Due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Minħabba konsiderazzjonijiet ta ’ sikurtà, Siklos huwa kontra- indikat f’ pazjenti b’ indeboliment tal- fwied serju (ara sezzjoni 4. 3 u 4. 4).
Method of administration Conforming with the individual dosage, the tablet or the halves or quarters of the tablet should be taken once daily, preferably in the morning before breakfast and, where necessary, with a glass of water or a very small amount of food.
Metodu ta ’ kif jingħata Skond id- dożaġġ individwali, il- pillolla jew in- nofsijiet jew kwartijiet ta ’ pillola iridu jittieħdu darba kuljum, preferibbilment fil- għodu qabel il- kolazzjoni u, meta neċessarju, ma ’ tazza ilma jew ammont żgħir ta ’ ikel.
Severe hepatic (Child-Pugh classification C) or severe renal impairment (creatinine clearance < 30ml/ min).
Indeboliment serju fil- fwied (Klassifikazzjoni C f’ Child- Pugh) fil- kliewi (eliminazzjoni tal- krejatinina < 30 ml/ min).
Toxic ranges of myelosuppression as described under section 4.2.
Limiti tossiċi ta ’ mijelosoppressjoni hekk kif deskritt f’ sezzjoni 4. 2.
Breast-feeding must be discontinued while taking Siklos (see section 4.6).
It- treddigħ għandu jitwaqqaf waqt li qed jittieħed Siklos (ara sezzjoni 4. 6).
3 Treatment with Siklos requires close clinical monitoring.
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu Kura b’ Siklos teħtieġ sorveljanza klinika mill- qrib.
The haematological status of the patient, as well as renal and hepatic functions should be determined prior to, and repeatedly during treatment.
L- qagħda emetoloġika tal- pazjent, kif ukoll l - funzjoni tal- kliewi u l- fwied irdu jiġu ddeterminati minn qabel, u b’ mod ripetut waqt il- kura.
During treatment with Siklos, blood counts must be monitored every two weeks at treatment initiation (i. e. for the first two months) and if the daily dose of hydroxycarbamide is up to 35 mg/ kg b. w.
Waqt kura b’ Siklos, l- għadd tad- demm iridu jiġu sorveljati kull ġimgħatejn mal- bidu tal- kura (i. e. għall - ewwel xahrejn) u jekk id- doża ta ’ kuljum ta ’ hydroxycarbamide hija sa ’ 35 mg/ kg piż tal- ġisem.
Patients who are stable on lower doses should be monitored every 2 months.
Pazjenti li huma stabbli b’ dożi iżgħar għandhom jiġu sorveljati kull xahrejn.
Treatment with Siklos should be discontinued if bone marrow function is markedly depressed.
3 Kura b’ Siklos trid titwaqqaf jekk il- funzjoni tal- mudullun ta ’ l- għadam tkun imnaqqsa ħafna.
Neutropenia is generally the first and most common manifestation of haematological suppression.
Newtropenja hija ġeneralment l- ewwel u l- aktar manifestazzjoni komuni ta ’ sopressjoni ematoloġika.
Thrombocytopenia and anaemia occur less frequently, and are rarely seen without a preceding neutropenia.
Tromboċitopenja u anemija jseħħu anqas ta ’ spiss, u rari jidru mingħajr ma jkun hemm newtropenja minn qabel.
Recovery from myelosuppression is usually rapid when therapy is discontinued.
Irkupru minn mijelosoppressjoni ġeneralment hija ta ’ malajr meta titwaqqaf il- kura.
Siklos therapy can then be re-initiated at a slightly lower dose (see section 4.2).
Wara kura b’ Siklos tista ’ terġa tinbeda b’ doża ħarira inqas (ara sezzjoni 4. 2).
Siklos should be used with caution in patients with mild to moderate renal or hepatic impairment (see section 4.2).
Siklos għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment ħafif għal moderat renali jew epatiku (ara sezzjoni 4. 2).
In patients with leg ulcers, Siklos should be used with caution.
F’ pazjenti b’ ulċeri fis- saqajn, Siklos għandu jintuża b’ attenzjoni.
Leg ulcers are a common complication of Sickle Cell Syndrome, but have also been reported in patients treated with hydroxycarbamide.
Ulċeri fis- saqajn huma komplikazzjoni komuni tas- Sindromu Sickle Cell, imma ġew irrapurtati wkoll f’ pazjenti kkurati b’ hydroxycarbamide.
Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Tossiċitajiet vaskulitiċi tal- ġilda, inkluż ulċeri vaskulitiċi u kankrena, seħħew f’ pazjenti b’ kundizzjonijiet mijeloproliferattivi waqt kura b’ hydroxycarbamide.
These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy.
Dawn it- tossiċitajiet vaskulitiċi kienu rrapurtati l- aktar f’ pazjenti bi storja ta ’, jew li bħalissa qed jieħdu, kura b’ interferon.
Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxycarbamide should be discontinued and/ or its dose reduced if cutaneous vasculitic ulcerations develop.
Minħabba riżultati potenzjalment severi klinikament ta ’ ulċeri vaskulitiċi tal- ġilda li ġew irrappurtati f’ pazjenti b’ mard mijeloproliferattiv, hydroxycarbamide għandu jitwaqqaf u/ jew id- doża tiegħu titnaqqas jekk ulċerazzjoni vaskulitika tal- ġilda tiżviluppa.
Rarely, ulcers are caused by leukocytoclastic vasculitis
Rari, ulċeri jiġu kkawżati b’ vaskulité lewkoċitoklastika.
Continuous follow-up of the growth of treated children is recommended.
Sorveljanza kontinwa ta ’ l- iżvilupp tat- tfal ikkurati hija rakkomandata.
Hydroxycarbamide causes macrocytosis, which may mask the incidental development of folic acid and vitamin B12 deficiency.
Hydroxycarbamide tikkawża makroċitożi, li tista ’ taħbi l- iżvilupp inċidentali ta ’ nuqqas ta ’ aċidu foliku u vitamina B12.
Prophylactic administration of folic acid is recommended.
L- għotja profilattika ta ’ aċidu foliku hija rakkomandata.
Patients and/ or parents or the legal responsible person must be able to follow directions regarding the administration of this medicinal product, their monitoring and care.
Pazjenti u/ jew ġenituri jew il- persuna legalment responsabbli iridu jkunu jistgħu jsegwu l - istruzzjonijiet dwar l- għotja ta ’ dan il- prodott mediċinali, u s- sorveljanza u l- kura tagħom.
Hydroxycarbamide is unequivocally genotoxic in a wide range of test systems.
Hydroxycarbamide huwa bla dubju ġenotossiku f’ sensiela vasta ta ’ sistemi ta ’ testijiet.