qanastek/EMEA-V3 huggingface dataset:
A daily regimen of 150 mg of Wilzin in three administrations was shown to be effective in significantly reducing copper absorption and inducing a negative copper balance.
Ammont ta ’ 150mg Wilzin kuljum fi tlett dożi kien muri li hu effettiv biex inaqqas b’ mod sinifikanti l- assorbiment ta 'copper u biex jikkaġuna bilanċ ta ’ copper negattiv
Since the mechanism of action of zinc is an effect on copper uptake at the level of the intestinal cell, pharmacokinetic evaluations based on blood levels of zinc do not provide useful information on zinc bioavailability at the site of action.
Peress li l- mekaniżmu ta ’ azzjoni ta 'zinc huwa effett fuq l- assorbiment ta' copper fil- livell taċ- ċellola intestinali, evalwazzjonijiet farmakokinetiċi fuq il- livelli ta 'zinc fid- demm ma jipprovdux informazzjoni utli fuq il - bijodisponibilità ta' zinc fis- sit ta ’ l- azzjoni.
Zinc is absorbed in the small intestine and its absorption kinetics suggest a tendency to saturation at increasing doses.
Zinc huwa assorbit mill- musrana ż- żgħira u l- kinetika ta ’ l- assorbiment tiegħu jissuggerixxu tendenza għas- saturazzjoni f’ dożi li jkunu qegħdin jiżdiedu.
Fractional zinc absorption is negatively correlated with zinc intake.
Assorbiment frazzjonali ta 'zinc huwa korelat b’ mod negattiv mat- teħid ta' zinc.
It ranges from 30 to 60% with usual dietary intake (7-15 mg/ d) and decreases to 7% with pharmacological doses of 100 mg/ d.
Ivarja fuq medda minn 30 sa 60% b’ teħid fid- dieta tas- soltu (7 - 15mg/ jum) u jonqos għal 7% b’ dożi farmakologiċi ta ’ 100mg/ jum.
In the blood, about 80% of absorbed zinc is distributed to erythrocytes, with most of the remainder being bound to albumin and other plasma proteins.
Fid- demm, madwar 80% ta 'zinc assorbit huwa mqassam liċ- ċelloli l- ħomor tad- demm, bil - maggoranza tal- kumplament ikun marbut ma ’ albumin u l- proteini tal- plażma oħrajn.
The liver is the main storage for zinc and hepatic zinc levels are increased during maintenance therapy with zinc.
Il- fwied huwa l - ħażna prinċipali għal zinc u l- livelli ta 'zinc fil- fwied jiżdiedu waqt terapija ta ’ manteniment b' zinc.
The plasma elimination half-life of zinc in healthy subjects is around 1 hour after a dose of 45 mg.
Il- half- life ta ’ l- eliminazzjoni ta 'zinc mill- plażma f’ pazjenti b’ saħħithom hija ta ’ madwar siegħa wara doża ta ’ 45 mg.
The elimination of zinc results primarily from faecal excretion with relatively little from urine and sweat.
L- eliminazzjoni ta 'zinc tirriżulta prinċipalment mill- eliminazzjoni ma ’ l- ippurgar b’ relattivament ftit ma ’ l- awrina u l- għaraq.
The faecal excretion is in the greatest part due to the passage of unabsorbed zinc but it is also due to endogenous intestinal secretion.
L- eliminazzjoni ma ’ l- ippurgar hija fl- akbar parti minħabba l- mogħdija ta ’ zinc mhux assorbit iżda hija ukoll minħabba tnixxija endogena intestinali.
Preclinical studies have been conducted with zinc acetate and with other zinc salts.
Studji ta ’ qabel l- użu kliniku saru b’ zinc acetate u b’ imluħa oħrajn ta 'zinc.
Pharmacological and toxicological data available showed large similarities between zinc salts and among animal species.
Tagħrif farmakoloġiku u tossikoloġiku disponibbli wrew xebħ kbir bejn l- imluħa ta 'zinc u fost speċi t’ annimali.
The oral LD50 is approximately 300 mg zinc/ kg body weight (about 100 to 150 times the human therapeutic dose).
L- LD50 orali hija bejn wieħed u ieħor 300mg zinc/ kg piż tal- ġisem (madwar 100 sa 150 darba d- doża terapewtika umana).
Repeat-dose toxicity studies have established that the NOEL (No Observed Effect Level) is about 95 mg zinc/ kg body weight (about 48 times the human therapeutic dose).
Studji tossikoloġici b’ dożi rrepetuti stabbilixxew li NOEL( No Observed Effect Level) hija madwar 95 mg zinc/ kg piż tal- ġisem (madwar 48 darba d- doża terapewtika umana).
The weight of evidence, from in vitro and in vivo tests, suggests that zinc has no clinically relevant genotoxic activity.
Il- piż ta ’ l- evidenza, minn testijiet in vitro u in vivo, tissuggerixxi li ż- zinc ma għandu l- ebda attività genotossika klinikament relevanti.
Reproduction toxicology studies performed with different zinc salts showed no clinically relevant evidence of embryotoxicity, foetotoxicity or teratogenicity.
Studji tossikoloġiċi fuq ir- riproduzzjoni magħmulin b’ imluħa ta 'zinc differenti ma wrew l- ebda evidenza klinikament relevanti ta ’ tossiċità fl- embrju, tossiċità fil- fetu jew teratoġeniċità.
No conventional carcinogenicity study has been conducted with zinc acetate dihydrate.
6 L- ebda studju konvenzjonali fuq il- karċinoġeniċità ma ġie magħmul b’ zinc acetate dihydrate.
Capsule content: maize starch magnesium stearate Capsule shell: gelatin titanium dioxide (E171) brilliant blue FCF (E133) Printing ink: black iron oxide (E172) shellac
Kontenut tal- kapsula: maize starch magnesium stearate Il- qoxra tal- kapsula: ġelatin titanium dioxide (E171) brilliant blue FCF (E133) Inka ta ’ l- istampar: black iron oxide (E172) shellac
White HDPE bottle which is equipped with a polypropylene and HDPE closure and contains a filler (cotton coil).
Flixkun HDPE abjad li hu mgħammar bi polypropylene u għeluq ta ’ l- HDPE u li fih filler (kojl tat - tajjar).
Each bottle contains 250 capsules.
Kull flixkun fih 250 kapsula.
Orphan Europe SARL Immeuble “ Le Wilson” F-92058 Paris-La-Défense - France
Orphan Europe SARL Immeuble “ Le Wilson ” F- 92058 Paris- La- Défense - Franza
13 October 2004
13 t’ Ottubru 2004
Wilzin 50 mg hard capsules
Wilzin 50 mg kapsuli iebsin
Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate).
Kull kapsula iebsa fiha 50 mg ta ’ zinc (li jikkorispondi għal 167. 84 mg ta ’ zinc acetate dihydrate).
Size 1 hard capsule with orange opaque cap and body, imprinted "93-377”.
Kapsula iebsa opaka ta ’ daqs 1 ta lewn oranġjo b' kappa ta 'l- istess kulur, li fuqha hemm stampat "93 - 377 ”.
Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson’ s disease (see section 4.4).
It- trattament b ’ Wilzin għandu jiġi mibdi taħt is- sorveljanza ta ’ tabib li għandu esperjenza fit - trattament tal- marda ta ’ Wilson (ara sezzjoni 4. 4).
Wilzin is a life-long therapy.
It- terapija b’ Wilzin tingħata għal għomrok.
Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible.
It- tagħrif fit- tfal ta ’ taħt is- 6 snin huwa limitat ħafna iżda peress li l- marda hija penetranti bi sħiħ trattament profilattiku għandu jiġi kkonsiderat mill- aktar fis possibbli.
In children who are unable to swallow capsules, these should be opened and their content suspended in a little water (possibly sugar or syrup flavoured water).
9 Fi tfal li mhumiex kapaċi jibilgħu l- kapsuli, dawn għandhom jiġu miftuħin u l- kontenut tagħhom jitħallat ma ’ ftit ilma (possibbilment ilma mħawwar biz- zokkor jew ġulepp).
When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for 8 the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Meta pazjent jinqaleb minn fuq trattament kelanti għal terapija ta ’ manteniment b’ Wilzin, it- trattament kelanti għandu jinzamm u jingħata ma Wilzin għal 2- 3 ġimgħat għaliex dan huwa ż- żmien li t - trattament b’ zinc jieħu biex jistimola induzzjoni massima ta ’ metallothionein u l- impediment totali ta ’ l- assorbiment ta 'copper.
Nevertheless, while awaiting zinc induced duodenal metallothionein production and consequential effective inhibition of copper absorption, zinc acetate dehydrate could be administered initially in symptomatic patients in combination with a chelating agent.
Madankollu, waqt l- istennija tal- produzzjoni ta’ metallothionein fid- duwodenu kawżata minn zinc u l - impediment effettiv ta ’ l- assorbiment ta 'copper b' konsegwenza ta dan, zinc acetate dihydrate jista ’ jingħata inizjalment f’ pazjenti sintomatici flimkien ma ’ mediċina kelanti.
Two patients of a series of 16 died from hepatic decompensation and advanced portal hypertension after being changed from penicillamine to zinc therapy.
Żewġ pazjenti minn 16- il pazjent mietu minn dekompensazzjoni tal- fwied u pressjoni għolja portali avvanzata wara li nqalbu minn fuq peniċillamine għal fuq terapija b’ zinc.
The non-ceruloplasmin plasma copper is calculated by subtracting the ceruloplasmin-bound copper from the total plasma copper, given that each milligram of ceruloplasmin contains 3 micrograms of copper.
Non- ceruloplasmin copper fil- plażma huwa kkalkulat billi jitnaqqas copper ċeruloplasmin fiha 3 mikrogrammi ta ’ copper.
Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine.
Il- livelli ta 'copper fl- awrina ġeneralment jogħlew b ’ terapija kelanti bħal ma hija penicillamine jew trientine.
Like with all anti-copper agents overtreatment carries the risk of copper deficiency, which is especially harmful for children and pregnant women since copper is required for proper growth and mental development.
Bħal f’ kull trattament b’ mediċini kontra r- copper, trattament eċċessiv iġor ir- riskju ta ’ defiċjenza ta 'copper, li hu speċjalment ta ’ ħsara għat- tfal u n- nisa tqal billi copper huwa meħtieġ għall- iżvilupp kif suppost u għall- iżvilupp mentali.
Laboratory follow-up including haematological surveillance and lipoproteins determination should also be performed in order to detect early manifestations of copper deficiency, such as anaemia and/ or leukopenia resulting from bone marrow depression, and decrease in HDL cholesterol and HDL/ total cholesterol ratio.
Eżamijiet ta 'wara fil- laboratorju li jinkludu sorveljanza ematoloġika u kejl tal’ lipoproteini għandhom isiru wkoll sabiex tiskopri manifestazzjonijiet bikrin ta ’ defiċjenza ta' copper, bħal anemija u/ jew
In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid- morning, between breakfast and lunch.
F’ kaz ta ’ intolleranza gastrika, li ta ’ spiss iseħħ bid- doża ta ’ filgħodu, din id- doża tista ’ tiġi mdewwma sa nofs l- għodwa, bejn il- kolazzjon u l- ikla ta ’ nofsinhar.
The capsule shell includes sunset yellow FCF (E110) which may cause allergic reactions.
Il- qoxra tal- kapsula tinkludi sunset yellow FCF (E110) li jista ’ jikkaġuna reazzjonijiet allerġiċi.
9 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
They showed no significant overall effect on copper balance although mild interaction of zinc with chelators (penicillamine and trientine) could be detected with decreased faecal but increased urinary copper excretion as compared with zinc alone.
Ma wrew l- ebda effett totali sinifikattiv fuq il- bilanċ ta 'copper għalkemm interazzjoni ħafifa ta' zinc ma ’ kelaturi (penicillamine u trientene) setgħet tiġi osservata bi tnaqqis fl- ippurgar iżda b’ żieda fl- eskrezzjoni ta 'copper fl- awrina meta mqabbla maż- zinc waħdu.
When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Meta pazjent ikun qed jinqaleb minn fuq trattament kelanti għal fuq Wilzin bħala terapija ta ’ manteniment, il- trattament kelanti għandu jitkompla u jingħata ma Wilzin għal 2- 3 gimagħat billi dan huwa ż- żmien li jieħu t- trattament b’ zinc biex jikkawża induzzjoni massima ta’ metallothionein u impediment totali ta ’ l- assorbiment ta 'copper.
The administration of the chelating treatment and Wilzin should be separated by at least 1 hour.
Bejn l- għoti tat- trattament kelanti u ta’ Wilzin għandha tgħaddi mill- inqas siegħa.
Other medicinal products The absorption of zinc may be reduced by iron and calcium supplements, tetracyclines and phosphorus-containing compounds, while zinc may reduce the absorption of iron, tetracyclines, fluoroquinolones.
Prodotti mediċinali oħrajn L- assorbiment ta 'zinc jista ’ jiġi mnaqqas minn supplimenti ta’ iron u ta' calcium, tetracyclines u prodotti li fihom phosphorus, filwaqt li zinc jista ’ jnaqqas l- assorbiment ta ’ iron, tetracyclines u fluoroquinolones.
Food Studies of the co-administration of zinc with food performed in healthy volunteers showed that the absorption of zinc was significantly delayed by many foods (including bread, hard boiled eggs, coffee and milk).
Ikel Studji fuq l- għoti flimkien ta' zinc ma ’ l- ikel ġo voluntiera b’ saħħithom urew li l- assorbiment ta 'zinc kien imdewwem b' mod sinifikanti minn ħafna ikel (li jinkludi ħobż, bajd iebes mgħolli, kafe u ħalib).
Dose adjustments to guarantee that the foetus will not become copper deficient must be done and close monitoring of the patient is mandatory (see section 4.4).
Aġġustamenti fid- doża biex jiżguraw li l- fetu ma jkollux nuqqas ta ’ copper għandhom jsiġu w monitoraġġ mill- qrib tal- pazjenta huwa obbligatorju (ara sezzjoni 4. 4)
Zinc is excreted in human breast milk and zinc-induced copper deficiency in the breast-fed baby may occur.
Zinc huwa eliminat fil- ħalib tas- sider ta ’ l- omm u jista ’ jkun hemm nuqqas ta 'copper ikkawżat minn zinc fit- tarbija li qed titredda.
Therefore, breast-feeding should be avoided during Wilzin therapy.
Ghaldaqstant, it- treddigħ għandu jiġi evitat waqt t- terapija b’ Wilzin.
10 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Clinical experience of more than 1 000 patient-years with zinc (more than 500 with zinc acetate dihydrate) as well as post-marketing surveillance with zinc acetate dihydrate of more than 1 000 patient-years showed that the most common undesirable effect is gastric irritation.
Esperjenza klinika fuq aktar minn 1000 sena ta ’ pazjenti b’ zinc (aktar minn 500 b’ zinc acetate dihydrate) kif ukoll sorveljanza ta ’ wara t- tqegħid fis- suq b’ zinc acetate dihydrate ta ’ aktar minn 1000 sena ta ’ pazjenti wriet li l- aktar effett mhux mixtieq komuni hija l- irritazzjoni gastrika.
Bone marrow examination usually reveals characteristic "ringed sideroblasts" (i. e. developing red blood cells containing iron-engorged paranuclear mitochondria).
Eżami tal- mudullun ġeneralment juri l- karatteristiċi“ sideroblasti biċ- ċrieki ” (i. e. ċelloli tad- demm ħomor li qed jiżviluppaw li fihom mitokondrija paranuklejari mimlijin bil- ħadid).
Pharmacotherapeutic group: various alimentary tract and metabolism product, ATC code:
Kategorija farmakoterapewtika: prodott ta 'partijiet varji ta' l- apparat alimentari u tal- metaboliżmu Kodiċi ATC:
When the liver capacity of storing copper is exceeded copper is released into the blood and is taken up in extra hepatic sites, such as the brain, resulting in motor disorders and psychiatric manifestations.
Meta l- kapaċità tal- fwied li jaħżen copper tiġi maqbuża copper joħroģ fid - demm u ma jiģix assorbit mill- fwied imma minn postijiet oħra, bħall- moħħ, li jirriżulta f’ disturbi fil - moviment u manifestazzjonijiet psikjattriċi.
Zinc induces the 11 production of metallothionein in the enterocyte, a protein that binds copper thereby preventing its transfer into the blood.
Zinc jqanqal il- produzzjoni ta ’ metallothionein fl - enteroċita, proteina li torbot copper magħha u b’ hekk ma thallix it- trasferiment tiegħu għal ġod- demm.
The liver is the main storage for zinc and hepatic zinc levels are increased during maintenance therapy with zinc.
Il- fwied huwa l - ħażna prinċipali għal zinc u l- livelli ta 'zinc fil- fwied jiżdiedu waqt terapija ta ’ manteniment b’ zinc.
The elimination of zinc results primarily from faecal excretion with relatively little from urine and sweat.
L- eliminazzjoni ta 'zinc tirriżulta prinċipalment mill- eliminazzjoni ma’ l- ippurgar b’ relattivament ftit ma’ l- awrina u l- għaraq.
The faecal excretion is in the greatest part due to the passage of unabsorbed zinc but it is also due to endogenous intestinal secretion.
L- eliminazzjoni ma’ l- ippurgar hija fl- akbar parti minħabba l- mogħdija ta’ zinc mhux assorbit iżda hija ukoll minħabba tnixxija endoġena intestinali.
Preclinical studies have been conducted with zinc acetate and with other zinc salts.
Studji ta ’ qabel l- użu kliniku saru b’ zinc acetate u b’ imluħa oħrajn ta’ zinc.
Pharmacological and toxicological data available showed large similarities between zinc salts and among animal species.
Tagħrif farmakoloġiku u tossikoloġiku disponibbli wrew xebħ kbir bejn l- imluħa ta’ zinc u fost speċi t’ annimali.
The weight of evidence, from in vitro and in vivo tests, suggests that zinc has no clinically relevant genotoxic activity.
Il- piż ta ’ l- evidenza, minn testijiet in vitro u in vivo, tissuggerixxi li zinc ma għandu l- ebda attività genotossika klinikament relevanti.
Reproduction toxicology studies performed with different zinc salts showed no clinically relevant evidence of embryotoxicity, foetotoxicity or teratogenicity.
Studji tossikoloġiċi fuq ir- riproduzzjoni magħmulin b’ imluħa ta’ zinc differenti ma wrew l- ebda evidenza klinikament relevanti ta ’ tossiċità fl- embrju, tossiċità fil- fetu jew teratoġeniċità.
No conventional carcinogenicity study has been conducted with zinc acetate dihydrate.
13 L- ebda studju konvenzjonali fuq il- karċinoġeniċità ma ġie magħmul b’ zinc acetate dihydrate.
Capsule content: maize starch magnesium stearate Capsule shell: gelatin titanium dioxide (E171) sunset yellow FCF (E110) Printing ink: black iron oxide (E172)
Kontenut tal- kapsula: maize starch magnesium stearate Il- qoxra tal- kapsula: ġelatin titanium dioxide (E171) sunset yellow FCF (E110) Inka ta ’ l- istampar: black iron oxide (E172) shellac
13 ANNEX II
15 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
14 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
16 A DETENTUR TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) tas- sustanza( i) bijoloġika( ċi) attiva( i)
Orphan Europe SARL Immeuble "Le Wilson" 70 avenue du Général de Gaulle F-92800 Puteaux France
Orphan Europe SARL Immeuble "Le Wilson" 70 avenue du Général de Gaulle F- 92800 Puteaux Franza
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq għandu jinforma l- Kummissjoni Ewropea dwar il- pjanijiet ta ’ kummerċjalizzazzjoni għall- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
15 ANNEX III
17 ANNESS III
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
19 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 25 mg hard capsules)
KAXXA TAL- KARTUN TA ’ BARRA U T- TIKKETTA TAL- FLIXKUN (Wilzin 25 mg kapsuli iebsin)
Wilzin 25 mg hard capsules Zinc acetate dihydrate
Wilzin 25 mg kapsuli iebsin Zinc acetate dihydrate
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate)
Kull kapsula iebsa tikkonsisti minn 25 mg ta 'zinc (li jikkorispondi għal 83. 92 mg ta ’ zinc acetate dihydrate)
250 hard capsules
250 kapsuli iebsin
Do not store above 25°C
Taħżinx f’ temperatura ’ l fuq minn 25 C
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 50 mg hard capsules)
KAXXA TAL- KARTUN TA ’ BARRA U T- TIKKETTA TAL- FLIXKUN (Wilzin 50 mg kapsuli iebsin)
Wilzin 50 mg hard capsules Zinc acetate dihydrate
Wilzin 50 mg kapsuli iebsin Zinc acetate dihydrate
Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate)
Kull kapsula iebsa tikkonsisti minn 50 mg ta ’ zinc (li jikkorispondi għal 167. 84 mg ta ’ zinc acetate dihydrate)
Wilzin 50 mg hard capsules Includes E110.
Jinkludi E110.
22 PACKAGE LEAFLET
24 FULJETT TA ’ TAGĦRIF
- This medicine has been prescribed for you personally and you should not pass it on to others.
TAGĦTIHIEX lil persuni oħra.
It
Tista ’ tagħmlilhom il- ħsara,
may harm them, even if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
What Wilzin is and what it is used for 2.
X’ inhu Wilzin u għalxiex jintuża 2.
Before you take Wilzin 3.
Qabel ma ’ tieħu Wilzin 3.
How to take Wilzin 4.
Kif għandek tieħu Wilzin 4.
Possible side effects 5 Storing Wilzin 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen Wilzin 6.
Wilzin 25 mg hard capsules Wilzin 50 mg hard capsules zinc acetate dihydrate
Wilzin 25 mg kapsuli iebsin Wilzin 50 mg kapsuli iebsin zinc acetate dihydrate
• The active substance is zinc acetate dihydrate.
Is- sustanza attiva hi zinc acetate dihydrate.
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate) or 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate). • The other ingredients are maize starch and magnesium stearate.
Kull kapsula iebsa tikkonsisti minn 25 mg ta ’ zinc (li jikkorispondi għal 83. 92 mg ta ’ zinc acetate dihydrate) jew 50 mg ta ’ zinc (li jikkorispondi għal 167. 84 mg ta ’ zinc acetate dihydrate).
The capsule shells contains gelatin, titanium dioxide (E171) and either brilliant blue FCF (E133) for Wilzin 25 mg or sunset yellow FCF (E110) for Wilzin 50 mg.
Il- qoxra tal- kapsula tikkonsisti minn ġelatina, titanium dioxide (E171) u jew brilliant blue FCF (E133) għal Wilzin 25 mg jew sunset yellow FCF (E110) għal Wilzin 50 mg.
The printing ink contains black iron oxide (E172) and shellac.
L- inka ta ’ l- istampar fiha black iron oxide (E172) u shellac.
Marketing Authorisation Holder and Manufacturer:
Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
WHAT WILZIN IS AND WHAT IT IS USED FOR
X’ INHU WILZIN U GĦALXIEX JINTUŻA
Wilzin 25 mg is an aqua blue hard capsule imprinted "93-376”.
Wilzin 25 mg hija kapsula iebsa ta ’ lewn ikħal li fuqha hemm stampat "93- 376 ”.
Wilzin 50 mg is a orange opaque hard capsule imprinted “ 93-377”.
Wilzin 50 mg hija kapsula iebsa opaka ta 'lewn oranġjo li fuqha hemm stampat “ 93- 377 ”.
It is available in packs of 250 hard capsules in a polyethylene bottle closed by a polypropylene and polyethylene closure.
Huwa jiġi f’ pakketti ta ’ 250 kapsuli iebsin fi flixkun ta 'polyethylene li jingħalaq b’ tapp ta' polypropylene u polyethylene.
The bottle also contains a cotton filler.
Il- flixkun fih ukoll filler tat- tajjar.
Wilzin is prescribed for the treatment of Wilson’ s disease, which is a rare inherited defect in copper excretion.
Wilzin jingħata b’ riċetta għat- trattament tal- marda ta ’ Wilson, li hi kundizzjoni rari li tintired fl - eskrezzjoni ta 'copper.
Dietary copper, which cannot be properly eliminated, accumulates first in the liver, then in other organs such as the eyes and the brain.
Copper fid- dieta, li ma jistax jiġi eliminat sew, jakkumula l- ewwel fil- fwied imbagħad f’ organi oħrajn bħal ma huma l- għajnejn u l- moħħ.
This potentially leads to liver damage and neurological disorders.
Dan potenzjalment iwassal għal ħsara fil- fwied u għal disturbi newroloġiċi.
Wilzin blocks the absorption of copper from the intestine thereby preventing its transfer into the blood and its further accumulation in the body.
Wilzin jimpedixxi l- assorbiment ta 'copper mill- imsaren biex b’ hekk jevita t- trasferiment tiegħu fid - demm u aktar akkumulazzjoni fil- ġisem.
Unabsorbed copper is then eliminated in the stool.
Copper li mhux assorbit mbagħad jiġi eliminat fl- ippurgar.
Wilson’ s disease will persist during the entire lifetime of the patient and therefore the need for this treatment is life-long.
Il- marda ta ’ Wilson tibqa ’ tippersisti matul ħajjet il- pazjent u għalhekk il- bżonn ta ’ dan it- trattament hu għal ħajtu kollha.
BEFORE YOU TAKE WILZIN
QABEL MA TIEĦU WILZIN
Do not take Wilzin:
Tieħux Wilzin:
If you are hypersensitive (allergic) to zinc or any of the other ingredients of Wilzin.
Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal zinc jew sustanza oħra ta ’ Wilzin.
Take special care with Wilzin:
Oqgħod attent ħafna b’ Wilzin:
Wilzin is usually not recommended for initial therapy of patients with signs and symptoms of Wilson’ s disease because of its slow onset of action.
Wilzin ġeneralment mhux rakkomandat bħala terapija inizjali f’ pazjenti li għandhom sinjali u sintomi tal- marda ta ’ Wilson minħabba li jdum biex jibda jaħdem.
If you are currently treated with another anti-copper agent, for example, penicillamine, your doctor may add Wilzin before stopping the initial treatment.
Jekk attwalment qed tingħata xi trattament ieħor b’ mediċina ta ’ kontra copper, per eżempju, penicillamine, it- tabib tiegħek għandu mnejn iżid Wilzin qabel ma jwaqqaf it- trattament inizjali.
As with other anti-copper agents such as penicillamine, your symptoms may get worse after starting the treatment.
Bħal fil- każ ta ’ mediċini oħra ta ’ kontra copper bħal penicillamine, is- sintomi tiegħek għandhom mnejn imorru għal agħar wara li tibda t- trattament.
In this case, you must inform your doctor.
F’ dak il- każ, għandek tinforma t- tabib tiegħek.
In order to follow up your condition and treatment your doctor will check your blood and urine on a regular basis.
Sabiex isegwi l- kundizzjoni u t- trattament tiegħek it- tabib tiegħek ser jiċċekkja d- demm u l- awrina tiegħek fuq bażi regolari.
This is to ensure that you receive sufficient treatment.
Dan biex jiġi żgurat li tirċievi trattament sodisfaċenti.
Monitoring may detect evidence of insufficient treatment (copper excess) or excessive treatment (copper deficiency), both of which can be harmful, particularly to growing children and pregnant women.
Il- monitoraġġ jista ’ jinnota xi evidenza ta ’ trattament insuffiċjenti (copper żejjed) jew trattament eċċessiv (nuqqas ta ’ copper), li t- tnejn jistgħu jkunu ta ’ ħsara, b’ mod partikolari għat- tfal u n- nisa tqal.
Taking Wilzin with food and drink:
Meta tieħu Wilzin ma ’ l- ikel u x- xorb:
Wilzin should be taken on an empty stomach, separated from mealtimes.
Wilzin għandu jittieħed fuq stonku vojt, mhux fil- ħinijet ta ’ l- ikel.
Dietary fibres and some dairy products, in particular, delay the absorption of zinc salts.
Fibri fid- dieta u xi prodotti tal - ħalib, b’ mod partikolari, iddewmu l- assorbiment ta ’ zinc salts.
Some patients experience stomach upset after the morning dose.
Xi pazjenti jkollhom tqalligħ fl- istonku wara d- doża ta ’ filgħodu.
Please discuss the matter with your Wilson’ s disease physician if this affects you.
Jekk jogħġbok kellem lit- tabib tiegħek li qed jieħu ħsibek għal marda ta ’ Wilson dwar dan jekk din taffettwak.
This side effect may be reduced by postponing the first dose of the day until mid-morning (between breakfast and the midday meal).
Dan l- effett mhux mixtieq jista ’ jitnaqqas jekk l- ewwel doża tal- jum tittieħed aktar tard f’ nofs l - għodwa (bejn il- kolazzjon u l- ikla ta ’ nofsinhar).
It may also be minimised by taking the first dose of Wilzin with a small amount of protein-containing food, such as meat (but not milk).
Tista ’ ukoll tiġi minimizzata billi l- ewwel doża ta 'Wilzin tittieħed ma ’ ammont żgħir ta ’ proteina bħal- laħam (imma mhux ħalib).
Pregnancy Please consult your doctor if you plan to become pregnant.
Tqala Jekk jogħġbok itlob il- parir tat- tabib tiegħek jekk qed tippjana li tinqabad tqila.
It is very important to continue anti-copper therapy during pregnancy.
Huwa importanti ħafna li tkompli t- terapija kontra copper waqt it- tqala.
If you become pregnant during therapy with Wilzin, your doctor will decide which treatment and which dose is best in your situation.
Jekk tinqabad tqila waqt it- terapija b’ Wilzin, it- tabib tiegħek għandu jiddeċiedi liema trattament u liema doża hija l- aħjar fis- sitwazzjoni tiegħek.
Breast-feeding Breast-feeding should be avoided if you are on Wilzin therapy.
Treddigħ It- treddigħ għandu jiġi evitat jekk qegħda fuq terapija b’ Wilzin.
Please discuss with your physician.
Jekk jogħġbok itlob il- parir tat- tabib tiegħek.
No studies of the effects on the ability to drive and use machines have been performed.
Ma saru ebda studji fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of Wilzin Wilzin 50 mg hard capsules include sunset yellow FCF (E110) which may cause allergic reactions.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Wilzin Il- kapsuli iebsin ta ’ Wilzin 50 mg jinkludu sunset yellow FCF (E110) li jista ’ jikkawża reazzjonijiet allerġiċi.
Please consult your doctor before taking any other medicines which may reduce the effectiveness of Wilzin, such as iron, calcium supplements, tetracyclines (antibiotics) or phosphorus.
Jekk jogħġbok itlob il- parir tat- tabib tiegħek qabel ma tieħu xi mediċini oħra li jistgħu inaqqsu l - effettività ta ’ Wilzin, bħal iron, supplimenti ta 'calcium, tetracyclines (antibijotiċi) jew phosphorus.
Conversely, the effectiveness of some medicines, such as iron, tetracyclines, fluoroquinolones (antibiotics), may be reduced by Wilzin.
Minn naħa l- oħra, l- effettività ta ’ ċertu mediċini, bħal iron, tetracyclines, fluoroquinolones (antibijotiċi), tista ’ titnaqqas b’ Wilzin.
HOW TO TAKE WILZIN
KIF GĦANDEK TIEĦU WILZIN
Wilzin treatment should be initiated and monitored by a physician experienced in the treatment of Wilson’ s disease.
It- trattament b’ Wilzin għandu jinbeda u jkun monitorat minn tabib li għandu l- esperjenza fit - trattament tal- marda ta ’ Wilson.
Always take Wilzin exactly as your doctor has instructed you.
Dejjem għandek tieħu Wilzin skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat- tabib jew l - ispiżjar tiegħek jekk ikollok xi dubju.
For the different dosage regimens Wilzin is available in hard capsules of 25 mg or 50 mg.
Għall- dożaġġi differenti Wilzin jiġi f’ kapsuli iebsin ta ’ 25 mg jew 50 mg.
• For adults:
Għall- adulti:
The usual dosage is:
Id- doża li ġeneralment tingħata hi ta ’ kapsula iebsa 1 ta ’ Wilzin 50 mg (jew 2 kapsuli iebsin ta ’ Wilzin 25 mg) tliet darbiet kuljum sa doża massima ta ’ kapsula iebsa 1 ta ’ Wilzin 50 mg (jew 2 kapsuli iebsin ta ’ Wilzin 25 mg) ħames darbiet kuljum.
- from 1 to 6 years:
•
- from 6 to 16 years if bodyweight under 57 kg:
Id- doża li ġeneralment tingħata hi: - minn 1 sa 6 snin:
1 hard capsule of Wilzin 25 mg
Kapsula iebsa 1 ta ’ Wilzin 25 mg darbtejn kuljum - minn 6 sa 16- il sena ta ’ piż tal- ġisem huwa taħt 57 kg:
- from 16 years or if bodyweight above 57 kg:
Kapsula iebsa 1 ta ’ Wilzin 25 mg tliet darbiet kuljum - minn 16- il sena jew jekk il- piż tal- ġisem huwa aktar minn 57 kg:
2 hard capsules of Wilzin 25 mg or 1 hard
2 kapsuli iebsin ta ’ Wilzin 25 mg jew kapsula iebsa ta ’ Wilzin 50 mg tliet darbiet kuljum.
Always take Wilzin on an empty stomach, at least one hour before or 2-3 hours after meals.
Dejjem għandek tieħu Wilzin fuq stonku vojt ta ’ lanqas siegħa qabel jew 2- 3 sigħat wara l- ikel.
If the morning dose is not well tolerated (see section 4) it is possible to delay it to mid-morning, between breakfast and lunch.
Jekk id- doża ta ’ filgħodu mhix ittolerata tajjeb (ara sezzjoni 4) tista ’ tingħata f’ nofs l- għodwa, bejn il - kolazzjon u l- ikla ta ’ nofsinhar.
It is also possible to take Wilzin with a little protein, such as meat.
Huwa possibbli wkoll li Wilzin jingħata ma ’ daqsxejn proteina bħalma hu l- laħam.
If you have been prescribed Wilzin with another anti-copper agent, such as penicillamine, keep an interval of at least 1 hour between the two medicines.
Jekk se tingħata mediċina oħra ma Wilzin li taħdem kontra copper, bħalma hi penicillamine, żomm intervall ta ’ lanqas siegħa bejn iż- żewġ mediċini.
To administer Wilzin to children who are unable to swallow capsules, open the capsule and mix the powder with a little water (possibly flavoured with sugar or syrup).
Sabiex tagħti Wilzin lit- tfal li mhumiex kapaċi jibilgħu kapsuli, iftaħ il- kapsula u ħallat it- trab b’ daqsxejn ilma (tista ’ żżidlu daqsxejn zokkor jew ġulepp għat- togħma).
If you take more Wilzin than you should:
Jekk tieħu Wilzin aktar milli suppost:
If you take more Wilzin than prescribed, you may experience nausea, vomiting and dizziness.
Jekk tieħu aktar Wilzin milli suppost, jista ’ jkun li jħossok mqalla, tirremetti jew tistordi.
In this case you must ask your physician for advice.
F’ dan il- każ itlob il- parir tat- tabib tiegħek.
If you forget to take Wilzin:
Jekk tinsa tieħu Wilzin:
Like all medicines, Wilzin can have side effects.
Bħal kull mediċina oħra, Wilzin jista ’ jkollu effetti sekondarji.
You may not have any of them, but tell your doctor as soon as possible if any of the following side effects bothers you or continues:
Jista ’ jkun li ma jkollok ebda wieħed minnhom, imma għarraf lit- tabib kemm jista ’ jkun malajr hekk kif xi effett sekondarju minn dawn idejqek jew jibqa jippersisti:
Common effects (1 to 10 of every 100 patients have these): • After Wilzin intake, gastric irritation may occur, especially at the beginning of treatment. • Changes in blood tests have been reported, including an increase in some liver and pancreatic enzymes.
Effetti komuni (Minn 1 sa 10 minn kull 100 pazjent għandhom dawn): • Wara litieħu Wilzin, jista ’ jkun hemm irritazzjoni gastrika speċjalment fil- bidu tat- trattament. • Ġew irraportati bidliet fit- testijiet tad- demm, li jinkludu żieda fil- livell ta ’ enżimi tal- fwied u tal- frixa.
Uncommon effects (less than 1 of every 100 patients have these):
Effetti mhux komuni (inqas minn 1 minn kull 100 pazjent ikollu dawn):
A decrease in blood red and white cells may occur.
Jista ’ jkun hemm tnaqqis fiċ- ċelloli l- ħomor u ċ- ċelloli l- bojod.
25 If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
27 Jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
STORING WILZIN
KIF TAĦŻEN WILZIN
Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25 C.
Do not use after the expiry date stated on the bottle and the carton.
Tużax wara d- data ta 'skadenza li tidher fuq Il- flixkun u l- kartuna.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
6 D - 63128 Dietzenbach Németország Tel: +49 6074 812160 Malta Orphan Europe SARL Immeuble “ Le Wilson” F - 92058 Paris La Défense France Tel: +33 1 47 73 64 58 Nederland Orphan Europe SARL Immeuble « Le Wilson » F-92058 Paris La Défense Frankreich Tél/ Tel: +33 1 47 73 64 58 Norge Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm Sverige Tel: +46 8 545 80 230
6 D - 63128 Dietzenbach Németország Tel: +49 (0) 6074 812160 Malta Orphan Europe SARL Immeuble “ Le Wilson ” F – 92058 Paris La Défense France Tel: +33 1 47 73 64 58 Nederland Orphan Europe SARL Immeuble “ Le Wilson ” F - 92058 Paris La Défense Frankrijk Tel: +33 1 47 73 64 58 Norge Orphan Europe Nordic AB Banérgatan 37 S - 11522 Stockholm Sverige Tel: +46 8 545 80 230
Eesti Orphan Europe Nordic AB Banérgatan 37 S- 11522 Stockholm Rootsi Tel: +46 8 545 80 230 Ελλαδα Orphan Europe SARL Immeuble “ Le Wilson” F - 92058 Paris La Défense Γαλλία Τηλ: +33 1 47 73 64 58
Eesti Orphan Europe Nordic AB Banérgatan 37 S - 11522 Stockholm Rootsi Tel: +46 8 545 80 230 Ελλαδα Orphan Europe SARL Immeuble “ Le Wilson ” F - 92058 Paris La Défense Γαλλία
26 España Orphan Europe, S. L.
Τηλ: +33 1 47 73 64 58 España Orphan Europe, S. L.
Portugal Orphan Europe, S. L.
Tel: +49 (0) 6074 812160 Portugal Orphan Europe, S. L.
This leaflet was last approved on:
Dan il- fuljett kien approvat l- aħħar fit -:
Xagrid 0.5mg hard capsule
Xagrid 0. 5mg kapsula iebsa
Each capsule contains 0.5 mg anagrelide (as 0.61 mg anagrelide hydrochloride)
Kull kapsula fiha 0. 5 mg anagrelide (bħala 0. 61 mg anagrelide hydrochloride) Għal- lista sħiħa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1..
Capsule, hard An opaque white hard capsule imprinted with S 063
Kapsula, iebsa Kapsula iebsa bajda matta li fuqha hemm stampat S 063
Xagrid is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.
Xagrid huwa indikat biex inaqqas l- għadd għoli tal- plejtlets f’ pazjenti li jkunu f’ riskju bi tromboċitemja essenzjali (ET) li ma jittolerawx it- terapija attwali tagħhom jew li l- għadd għoli tal - plejtlets tagħhom ma jitnaqqasx għal- livell aċċettabbli bit- terapija attwali tagħhom.
An at risk patient An at risk essential thrombocythaemia patient is defined by one or more of the following features: > 60 years of age or A platelet count > 1000 x 109/ l or A history of thrombo-haemorrhagic events.
Pazjent li jkun f’ riskju Pazjent bi tromboċitemja essenzjali li jkun f’ riskju huwa ddefenit b’ waħda jew aktar mill- karatteristiċi li ġejjin: `l fuq minn 60 sena jew Għadd tal- plejtlets > 1000 x 109/ l jew Passat mediku ta ’ reazzjonijiet trombo- emorraġiċi.
Treatment with Xagrid capsules should be initiated by a clinician with experience in the management of essential thrombocythaemia.
Trattament b’ kapsuli ta ’ Xagrid għandu jinbeda minn tabib b’ esperjenza fl- immaniġġjar ta ’ tromboċitemja essenzjali.
The recommended starting dosage of anagrelide is 1mg/ day, which should be administered orally in two divided doses (0.5mg/ dose).
Id- dożaġġ tal- bidu rrakkomandat ta ’ anagrelide huwa ta ’ 1mg/ jum, li għandu jingħata oralment f’ żewġ dożi maqsumin (0. 5mg/ doża).
The starting dose should be maintained for at least one week.
Id- doża tal- bidu għandha tinżamm għal ta ’ lanqas ġimgħa.
After one week the dosage may be titrated, on an individual basis, to achieve the lowest effective dosage required to reduce and/ or maintain a platelet count below 600 x 109/ l and ideally at levels between 150 x 109/ l and 400 x 109/ l.
Wara ġimgħa d- dożaġġ għandu jiġi ttittrat, fuq bażi ndividwali, biex tikseb l- anqas doża effettiva meħtieġa biex tnaqqas u/ jew iżżomm l - għadd tal- plejtlets anqas minn 600 x 109/ l u idejalment f’ livelli bejn 150 x 109/ l u 400 x 109/ l.
The dosage increment must not exceed more than 0.5mg/ day in any one-week and the recommended maximum single dose should not exceed 2.5mg (see section 4.9).
Iż- żieda fid- doża m’ għandhiex tkun aktar minn 0. 5mg/ jum fi kwalunkwe ġimgħa u d- doża waħdanija massima rakkomandata m’ għandhiex taqbeż 2. 5mg (ara sezzjoni 4. 9).
During clinical development dosages of 10mg/ day have been used.
Waqt żvilupp kliniku ntużaw dożaġġi ta ’ 10mg/ jum.
The effects of treatment with anagrelide must be monitored on a regular basis (see section 4.4).
L- effetti ta ’ trattament b’ anagrelide għandhom jiġu mmonitorjati fuq bażi reġolari (ara sezzjoni 4. 4).
If the starting dose is > 1mg/ day platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until a stable maintenance dose is reached.
Jekk id- doża tal- bidu hija > 1mg/ jum, l- għadd tal- plejtlets għandu jsir kull jumejn matul l- ewwel ġimgħa tat- trattament u ta ’ l- anqas kull ġimgħa minn hemm ’ l quddiem sakemm tintlaħaq doża stabbli li tinżamm.
Typically, a fall in the platelet count will be observed within 14 to 21 days of starting treatment and in most patients an adequate therapeutic response will be observed and maintained at a dosage of 1 to 3mg/ day (for further information on the clinical effects refer to section 5.1).
Tipikament, tnaqqis fl- għadd tal- plejtlets għandu jiġi osservat fi żmien 14 sa 21 ġurnata minn mindu jinbeda t- trattament u fil- parti l- kbira tal- pazjenti reazzjoni terapewtika adegwata tiġi osservata u miżmuma f’ dożaġġ ta ’ 1 sa 3mg/ jum (għal aktar informazzjoni fuq l- effetti kliniċi ara sezzjoni 5. 1).
2 Elderly The observed pharmacokinetic differences between elderly and young patients with ET (see section 5.2) do not warrant using a different starting regimen or different dose titration step to achieve an individual patient-optimised anagrelide regimen.
Anzjani Id- differenzi farmakokinetiċi osservati bejn pazjenti anzjani u żgħażagħ bl- ET (ara sezzjoni 5. 2) ma jiġġustifikawx l- użu ta ’ kors tal- bidu differenti jew pass differenti tat- titrazzjoni tad- doża biex jittwettaq kors ta ’ anagrelide li jkun ottimizzat għall- pazjent individwali.
During clinical development approximately 50% of the patients treated with anagrelide were over 60 years of age and no age specific alterations in dosage were required in these patients.
2 Waqt l- iżvilupp kliniku bejn wieħed u ieħor 50% tal- pazjenti ttrattati b’ anagrelide kellhom età ta ’ ’ l fuq minn 60 sena u l- ebda tibdil speċifiku fid- dożaġġ minħabba l- età ma kien meħtieġ f’ dawn il - pazjenti.
However, as expected, patients in this age group had twice the incidence of serious adverse events (mainly cardiac).
Madankollu, kif mistenni, pazjenti f’ dan il- grupp ta ’ età kellhom inċidenza doppja ta ’ reazzjonijiet avversi (prinċipalment kardijaċi).
Renal impairment Currently, there are no specific pharmacokinetic data for this patient population and the potential risks and benefits of anagrelide therapy in a patient with impairment of renal function should be assessed before treatment is commenced.
Indeboliment renali Attwalment, ma hemm l- ebda dejta speċifika għal din il- popolazzjoni ta ’ pazjenti u r- riskju potenzjali u s- siwi ta ’ terapija b’ anagrelide f’ pazjent b’ indeboliment tal- funzjoni renali għandhom jiġu valutati qabel ma jinbeda t- trattament.
Hepatic impairment Currently, there are no specific pharmacokinetic data for this patient population.
Indeboliment epatiku Attwalment, ma hemm l- ebda dejta speċifika għal din il- popolazzjoni ta ’ pazjenti.
However, hepatic metabolism represents the major route of drug clearance and liver function may therefore be expected to influence this process.
Madankollu, il - metaboliżmu epatiku jirrappreżenta l- passaġġ ewlieni ta ’ eliminazzjoni tal- mediċina u l- funzjoni tal - fwied għalhekk tista ’ tiġi mistennija li tinfluwenza dan il- proċess.
The potential risks and benefits of anagrelide therapy in a patient with mild impairment of hepatic function should be assessed before treatment is commenced (see sections 4.3 and 4.4).
Għalhekk huwa rrakkomandat li pazjenti b’ indeboliment moderat jew serju ma jiġux ittrattati b’ anagrelide. Ir- riskji potenzjali u s- siwi ta ’ terapija b’ anagrelide f’ pazjent b’ indeboliment ħafif tal- funzjoni epatika għandhom jiġu mkejla qabel ma jinbeda t- trattament (ara sezzjonijiet 4. 3 u 4. 4).
Hypersensitivity to anagrelide or to any of the excipients of the medicinal product.
Sensittività eċċessiva għal anagrelide jew għal xi sustanzi mhux attivi tal- prodott mediċinali.
Patients with moderate or severe hepatic impairment.
Pazjenti b' indeboliment epatiku moderat jew serju.
Patients with moderate or severe renal impairment (creatinine clearance < 50ml/ min).
Pazjenti b' indeboliment renali moderat jew serju (rata ta 'eliminazzjoni tal- krejatinina < 50ml/ min).
(see sections 4.2 and 4.3) the potential risks and benefits of anagrelide therapy in a patient with mild impairment of hepatic function should be assessed before treatment is commenced.
Indeboliment epatiku (ara sezzjonijiet 4. 2 u 4. 3) Ir- riskji potenzjali u s- siwi ta ’ terapija b’ anagrelide f’ pazjent b’ indeboliment ħafif tal- funzjoni epatika għandhom jiġu valutati qabel ma jinbeda t - trattament.
It is not recommended in patients with elevated transaminases (> 5 times the upper limit of normal).
Mhux rrakkomandat f’ pazjenti bi transaminases għoljin (> 5 darbiet mil- limitu ta ’ fuq tan - normal).
(see sections 4.2 and 4.3) the potential risks and benefits of anagrelide therapy in a patient with impairment of renal function should be assessed before treatment is commenced.
Indeboliment renali (ara sezzjonijiet 4. 2 u 4. 3) Ir- riskji potenzjali u s- siwi ta ’ terapija b’ anagrelide f’ pazjenti b’ indeboliment ħafif tal- funzjoni renali għandhom jiġu valutati qabel ma jinbeda t - trattament.
General: therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), and assessment of liver function (ALT and AST) and renal function (serum creatinine and urea) tests.
Ġenerali: it- terapija li għandha tinkludi l- għadd tad- demm komplut (emoġlobina u ċelloli bojod tad - demm u għadd tal- plejtlets), u stima ta ’ testijiet tal- funzjoni tal- fwied (ALT u AST) u tal- funzjoni renali (krejatinina fis- serum u ureja) teħtieġ sorveljanza klinika mill- qrib tal- pazjent.
Platelets: the platelet count will increase within 4 days of stopping treatment with Xagrid capsules and will return to pre-treatment levels within 10 to 14 days.
Plejtlets: l- għadd tal- plejtlets jiżdied fi żmien 4 ijiem mit- twaqqif ta ’ trattament bil - kapsuli ta ’ Xagrid u jirritorna għal- livelli ta ’ qabel it- trattament fi żmien 10 sa 14- il jum.
Cases of cardiomegaly and congestive heart failure have been reported (see section 4.8).
Kardjovaskulari Każijiet ta ’ kardjomegalija u insuffiċjenza tal- qalb konġestiva ġew irrapportati (ara sezzjoni 4. 8).
Anagrelide should be used with caution in patients of any age with known or suspected heart disease, and only if the potential benefits of therapy outweigh the potential risks.
Anagrelide għandu jintuża b’ kawtela f’ pazjenti ta ’ kull età b’ mard tal- qalb ikkonfermat jew suspettat, u għandu jintuża biss jekk is- siwi potenzjali tat- terapija jegħleb ir- riskji potenzjali.
Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and because of its positive inotropic effects, a pre- treatment cardiovascular examination (including further investigation such as echocardiography, electrocardiogram) is recommended.
Anagrelide huwa impeditur ta ’ cyclic AMP phosphodiesterase III u minħabba l- effetti inotropiċi pożittivi tiegħu, eżami kardjovaskulari qabel it- trattament (li jinkludi aktar investigazzjonijiet bħal ekokardjografija, elektrokardjogramma) huwa rrakkomandat.
Patients should be monitored during treatment for evidence of cardiovascular effects that may require further cardiovascular examination and investigation.
Waqt it- trattament, pazjenti ghandħom jiġu mmonitorjati għal evidenza ta ’ effetti kardjovaskulari li jistgħu jehtieġu iktar eżamijiet u nvestigazzjonijiet.
Paediatric patients:
Pażjenti pedjatriċi:
(see section 5.1) limited data are available on the use of anagrelide in the paediatric population and anagrelide should be used in this patient group with caution.
(ara sezzjoni 5. 1) hemm dejta ristretta dwar l- użu ta ’ anagrelide fil- popolazzjoni pedjatrika u anagrelide għandu jintuża b' kawtela f’ dan il- grupp ta ’ pazjenti.
3 Clinically relevant interactions: anagrelide is an inhibitor of cyclic AMP phosphodiesterase III (PDE III).
3 Interazzjonijiet klinikament rilevanti: anagrelide huwa impeditur ta ’ cyclic AMP phosphodiesterase III (PDE III).
Concomitant use of anagrelide with other PDE III inhibitors such as milrinone, amrinone, enoximone, olprinone and cilostazol is not recommended.
L- użu ta ’ anagrelide flimkien ma ’ impedituri oħrajn PDE III bħal ma huma milrinone, amrinone, enoximone, olprinone u cilostazol mhux rakkomandat.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi rari ereditarji ta ’ intolleranza għal galactose, defiċjenza tal- lactase ta ’ Lapp jew assorbiment ħażin ta ’ glucose- galactose, m’ għandhomx jieħdu din il- mediċina.