qanastek/EMEA-V3 huggingface dataset:
4 4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Interactions between deferiprone and other medicinal products have not been reported.
Interazzjonijiet bejn deferiprone u prodotti mediċinali oħrajn ma kinux irrappurtati.
However, since deferiprone binds to metallic cations, the potential exists for interactions between deferiprone and trivalent cation-dependent medicinal products such as aluminium-based antacids.
Madankollu, billi deferiprone jeħel ma ’ cations metalliċi, jeżisti l- potenzjal għal interazzjonijiet bejn deferiprone u l - prodotti mediċinali trivalenti li huma dipendenti fuq il- cations, bħall- antaċidi bbażati fuq l- aluminju.
Therefore, it is not recommended to concomitantly ingest aluminium-based antacids and deferiprone.
Għalhekk mhux irrakkomandat li tieħu antaċidi bbażati fuq l- aluminju u deferiprone fl- istess ħin.
The safety of concurrent use of deferiprone and vitamin C has not been formally studied.
Is- sigurtà ta ’ l- użu flimkien ta ’ deferiprone u l- vitamina Ċ għadha ma ġietx studjata formalment.
Based on the reported adverse interaction that can occur between deferoxamine and vitamin C, caution should be used when administering deferiprone and vitamin C concurrently.
Skond l- interazzjoni avversa rrappurtata li tista ’ sseħħ bejn deferoxamine u l- vitamina Ċ, għandha tingħata attenzjoni meta deferiporne u l- vitamina Ċ jingħataw ma ’ xulxin.
Due to the unknown mechanism of deferiprone induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.3).
Minħabba l- mekkaniżmu mhux magħruf dwar newtropenja sensitizzata minn deferiprone, pazjenti m’ għandhomx jieħdu prodotti mediċinali magħrufa li huma assoċjati ma ’ newtropenja jew dawk li jistgħu jikkawżaw agranuloċitosi (ara sezzjoni 4. 3)
Pregnancy There are no adequate data from the use of deferiprone in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ deferiprone f’ nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq bhejjem urew tossiċità riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju potenzjali għall- bnedmin mhuwiex magħruf.
Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of the medicinal product.
Nisa li jista ’ jkollhom it- tfal għandhom jiġu avżati biex ma joħorġux tqal minħabba l- proprjetajiet klastoġeniċi u teratoġeniċi tal- prodott mediċinali.
These women should be counselled to take contraceptive measures and must be advised to immediately stop taking deferiprone if they become pregnant or plan to become pregnant (see section 4.3).
Dawn in- nisa għandu jingħatalhom parir biex jużaw miżuri kontraċettivi, u għandu jingħatalhom parir biex jieqfu jieħdu deferiprone immedjatament jekk joħorġu tqal jew jekk qed jippjanaw li joħorġu tqal (ara sezzjoni 4. 3).
Lactation It is not known whether deferiprone is excreted in human milk.
Treddigħ Mhux magħruf jekk deferiprone jitneħħiex fil- ħalib tal- bniedem.
No prenatal and postnatal reproductive studies have been conducted in animals.
Ma saru l- ebda studji dwar ir - riproduzzjoni fl- annimali, qabel jew wara t- twelid.
Deferiprone must not be used by breast-feeding mothers.
Deferiprone m’ għandux jintuża minn nisa li jreddgħu.
If treatment is unavoidable, breast feeding must be stopped.
Jekk it- trattament ma jkunx jista ’ jiġi evitat, it- treddigħ għandu jitwaqqaf.
The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils < 0.5x109/ l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
L- aktar effett serju mhux mixtieq irrappurtat fi provi kliniċi b’ deferiprone hu l- agranuloċitosi (newtrofili < 0. 5x109/ l), b’ inċidenza ta ’ 1. 1% (0. 6 każijiet għal kull 100 sena ta ’ kura lill- pazjenti) (ara sezzjoni 4. 4).
The observed incidence of the less severe form of neutropenia (neutrophils < 1.5x109/ l) is 4.9% (2.5 cases per 100 patient-years).
L- inċidenza osservata tal- forma inqas serja ta ’ newtropenja (newtrofili < 1. 5x109/ l) hi ta ’ 4. 9% (2. 5 każijiet għal kull 100 sena ta ’ kura lill- pazjenti).
This rate should be considered in the context of the underlying elevated incidence of neutropenia in thalassaemia patients, particularly in those with hypersplenism.
Din ir- rata għandha tiġi kkunsidrata fil - kuntest ta ’ l- inċidenza għolja ta ’ newtropenja f’ pazjenti bit- talassemja, b’ mod partikulari dawk b’ iperspleniżmu.
Episodes of diarrhoea, mostly mild and transient, have been reported in patients treated with deferiprone.
Episodji ta ’ dijarea, il- biċċa l- kbira ħafifa u temporanja, kienu rrappurtati f’ pazjenti li kienu kkurati b’ deferiprone.
Gastrointestinal effects are more frequent at the beginning of therapy and resolve in most patients within a few weeks without the discontinuation of treatment.
L- effetti gastrointestinali huma aktar frekwenti fil- bidu tat- terapija, u fil- biċċa l- kbira tal- pazjenti jfiequ wara ftit ġimgħat mingħajr it- twaqqif tat- trattament.
In some patients it may be beneficial to reduce the dose of deferiprone and then scale it back up to the former dose.
F’ xi pazjenti jista ’ jkun ta ’ benefiċċju li tnaqqas id- doża ta ’ deferiprone u mbagħad terġa ’ żżidha bil- mod sad- doża ta ’ qabel.
Arthropathy events, which ranged from mild pain in one or more joints to severe arthritis with effusion and significant disability, have also been reported in patients treated with deferiprone.
Avvenimenti ta ’ artropatija, li kienu jvarjaw minn uġigħ ħafif f’ wieħed jew aktar mill- ġogi, sa artrite severa b’ effużjoni u diżabilità sinifikanti, kienu rrappurtati wkoll f’ pazjenti li kienu kkurati b’ deferiprone.
Mild arthropathies are generally transient.
Artropatiji ħfief ġeneralment huma temporanji.
Increased levels of serum liver enzymes have been reported in patients taking deferiprone.
Livelli għolja ta ’ enzimi tas- serum fil- fwied kienu rrappurtati f’ pazjenti li kienu qed jieħdu deferiprone.
In the majority of these patients, the increase was asymptomatic and transient, and returned to baseline without discontinuation or decreasing the dose of deferiprone (see section 4.4).
Fil- maġġoranza ta ’ dawn il- pazjenti, din iż- żjieda kienet mingħajr sintomi u temporanja, u reġgħet lura lejn il- linja bażi mingħajr ma d- doża ta ’ deferiprone twaqqfet jew tnaqqset (ara sezzjoni 4. 4).
Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
5 Xi pazjenti ġarrbu progressjoni tal- fibrożi li kienet assoċjata ma ’ żjieda fil- livelli żejda ta ’ ħadid jew ta ’ epatite Ċ.
5 Low plasma zinc levels have been associated with deferiprone, in a minority of patients.
Livelli baxxi ta ’ żingu fil- plażma kienu assoċjati ma ’ deferiprone, f’ minoranza ta ’ pazjenti.
The levels normalised with oral zinc supplementation.
Il- livelli ġew lura għan- normal meta ttieħdet doża supplimentari ta ’ żingu mill- ħalq.
Neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/ kg/ day for several years.
Disturbi newroloġiċi (bħal sintomi ċerebellari, diplopja, nystagmus laterali, psychomotor slowdown, movimenti ta ’ l- idejn u ipotonija assjali) kienu osservati fi tfal li, b’ mod voluntarju, ingħataw riċetta li kienet 2. 5 darbiet aktar mid- doża massima rakkomandata ta ’ 100 mg/ kg/ jum għal diversi snin.
The neurological disorders progressively regressed after deferiprone discontinuation (see sections 4.2, 4.4 and 4.9).
Id - disturbi newroloġiċi naqsu b’ mod progressiv wara t- twaqqif ta ’ deferiprone (ara sezzjonijiet 4. 2, 4. 4 u 4. 9).
Adverse reaction frequencies:
Frekwenzi ta ’ reazzjonijiet avversi:
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100).
Komuni ħafna (≥1/ 10), Komuni (≥1/ 100 sa < 1/ 10), Mhux komuni (≥1/ 1, 000 sa < 1/ 100).
SYSTEM ORGAN CLASS Investigations Blood and lymphatic system disorders Nervous system disorders
SISTEMA TAL- KLASSIFIKA TA ’ L- ORGANI
VERY COMMON (≥ 1/ 10)
KOMUNI ĦAFNA (≥1/ 10)
COMMON (≥ 1/ 100 to < 1/ 10) Increased liver enzymes Neutropenia Agranulocytosis Headache
KOMUNI (≥1/ 100 SA < 1/ 10)
UNCOMMON (≥ 1/ 1,000 to < 1/ 100)
MHUX KOMUNI (≥1/ 1, 000 SA < 1/ 100)
Gastrointestinal disorders
Investigazzjonijiet
Nausea Abdominal Pain Vomiting
Żjieda fl- enzimi tal - fwied
Renal and urinary disorders
Nawseja Uġigħ ta ’ żaqq Rimettar
Chromaturia
Kromaturja
Increased Appetite
Żjieda fl- aptit
No cases of acute overdose have been reported.
L- ebda każ ta ’ doża eċċessiva ma kien irrappurtat.
However, neurological disorders (such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia) have been observed in children who had been voluntarily prescribed more than 2.5 times the maximum recommended dose of 100 mg/ kg/ day for several years.
Madankollu, disturbi newroloġiċi (bħal sintomi ċerebellari, diplopja, nystagmus laterali, psychomotor slowdown, movimenti ta ’ l- idejn u ipotonija assjali) kienu osservati fi tfal li, b’ mod voluntarju, ingħataw riċetta li kienet 2. 5 darbiet aktar mid- doża massima rakkomandata ta ’ 100 mg/ kg/ jum għal diversi snin.
The neurological disorders progressively regressed after deferiprone discontinuation.
Disturbi newroloġiċi naqsu b’ mod progressiv wara li deferiprone twaqqaf.
In case of overdose, close clinical supervision of the patient is required.
F’ każ ta ’ doża eċċessiva, superviżjoni klinika mill- qrib tal- pazjent hi meħtieġa.
Iron chelating agents, ATC code:
Aġenti kelanti tal- ħadid, Kodici ATC:
The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds to iron in a 3:1 molar ratio.
6 Is- sustanza attiva hi deferiprone (3- hydroxy- 1, 2- dimethylpyridin- 4- one), ligand bidentate li jeħel mal - ħadid fi proporzjon molari ta ’ 3: 1.
Clinical studies have demonstrated that deferiprone is effective in promoting iron excretion and that a dose of 25 mg/ kg three times per day can prevent the progression of iron accumulation as assessed by serum ferritin, in patients with transfusion-dependent thalassaemia.
Studji kliniċi wrew li deferiprone hu effettiv biex jippromwovi t- tneħħija tal- ħadid, u li doża ta ’ 25 mg/ kg kuljum tista ’ timpedixxi l- progressjoni ta ’ l- akkumulazzjoni tal- ħadid hekk kif evalwat mill - ferritin fis- serum, f’ pazjenti li għandhom it- talessimja li huma dipendenti fuq it- trasfużjoni.
However, chelation therapy may not necessarily protect against iron-induced organ damage.
Madankollu, it- terapija tal- kelazzjoni tista ’ ma tipproteġix kontra l- ħsara fl- organi kkaġunata mill - ħadid.
6 Deferiprone has been investigated in 247 patients in two phase III trials and a compassionate use programme.
Deferiprone kien investigat f’ 247 pazjent f’ żewġ provi ta ’ fażi III u fi programm ta ’ użu compassionate.
Serum ferritin was chosen as the primary efficacy criterion in the studies.
Il- ferritin fis- serum intgħażel bħala l- kriterju primarju ta ’ l- effikaċja fl- istudji.
In one study of two-year duration deferiprone was compared to deferoxamine.
Fi studju minnhom li dam sejjer sentejn, deferiprone tqabbel ma ’ deferoxamine.
The mean serum ferritin levels were not significantly different in the two treatment groups, but mean hepatic iron concentration in deferiprone treated patients seems to increase more than in deferoxamine treated patients.
Il- livelli medji ta ’ ferritin fis- serum ma kinux differenti b’ mod sinifikanti fiż- żewġ gruppi tal- kura, imma l- medja tal - konċentrazzjoni ta ’ ħadid epatiku f’ pazjenti kkurati b’ deferiprone jidher li tiżdied aktar minn dik ta ’ pazjenti kkurati b’ deferoxamine.
Therefore deferiprone at the recommended dose could be less effective than deferoxamine.
Għalhekk deferiprone fid- doża rakkomandata jista ’ jkun inqas effettiv minn deferoxamine.
The other study was a supportive open, non-comparative study.
L- istudju l- ieħor kien studju tat- tip supportive open u mhux komparattiv.
In this study patients maintained serum ferritin values at pre-study levels.
F’ dan l- istudju, il- pazjenti żammew il- valuri ta ’ ferritin fis- serum fil- livelli ta ’ qabel l- istudju.
The primary end-point was the incidence of agranulocytosis, which occurred at a frequency of 1.2%.
Il- punt aħħari primarju kienet l - inċidenza ta ’ agranuloċitosi, li seħħet bi frekwenza ta ’ 1. 2%.
Absorption Deferiprone is rapidly absorbed from the upper part of the gastrointestinal tract.
Assorbiment Deferiprone hu assorbit malajr mill- parti ta ’ fuq ta ’ l- apparat gastrointestinali.
Peak serum concentration is reported to occur 45 to 60 minutes following a single dose in fasted patients.
L- ogħla konċentrazzjoni fis- serum hi rrappurtata li sseħħ minn 45 sa 60 minuta wara t- teħid ta ’ doża waħda f’ pazjenti sajmin.
This may be extended to 2 hours in fed patients.
Dan il- ħin jista ’ jiġi estiż għal sagħtejn f’ pazjenti li jkunu kielu.
Following a dose of 25 mg/ kg, lower peak serum concentrations have been detected in patients in the fed state (85 μ mol/ l) than in the fasting state (126 μ mol/ l), although there was no decrease in the amount of deferiprone absorbed when it was given with food.
Wara doża ta ’ 25 mg/ kg, konċentrazzjonijiet massimi iktar baxxi fis- serum kienu osservati fil- pazjenti li jkunu kielu (85 μmol/ l) milli f’ dawk fl- istat sajjem (126 μmol/ l), għalkemm ma kienx hemm tnaqqis fl- ammont ta ’ deferiprone assorbit meta dan ingħata ma ’ l- ikel.
Biotransformation Deferiprone is metabolised predominantly to a glucuronide conjugate.
Biotrasformazzjoni Deferiprone hu metabolat l- aktar għall- konjugat glucuronide.
This metabolite lacks iron-binding capability due to inactivation of the 3-hydroxy group of deferiprone.
Dan il- metabolit m’ għandux il- kapaċità li jeħel mal- ħadid minħabba l- inattivazzjoni tal- grupp 3- hydroxy ta ’ deferiprone.
Peak serum concentrations of the glucuronide occur 2 to 3 hours after administration of deferiprone.
Konċentrazzjonijiet massimi tal- glukoronide fis- serum iseħħu minn 2 sa 3 sigħat wara t- teħid ta ’ deferiprone.
Elimination In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
Eliminazzjoni Fil- bniedem, deferiprone jiġi eliminat prinċipalment mill- kliewi; minn 75% sa 90% tad- doża li tittieħed hi rrappurtata li tiġi rkuprata fl- awrina fl- ewwel 24 siegħa, fil- forma ta ’ deferiprone liberu, metabolit glucuronide u kumpless ħadid- deferiprone.
A variable amount of elimination via the faeces has been reported.
Ammont varjabbli ta ’ eliminazzjoni permezz ta ’ l- ippurgar kien irrappurtat.
The elimination half-life in most patients is 2 to 3 hours.
Il- half- life ta ’ l- eliminazzjoni fil- biċċa l- kbira tal- pazjenti hi minn 2 sa 3 sigħat.
Non-clinical studies have been conducted in animal species including mice, rats, rabbits, dogs and monkeys.
Studji mhux kliniċi saru fuq speċi ta ’ annimali inklużi ġrieden, firien, fniek, klieb u xadini.
The most common findings in non-iron-loaded animals at doses of 100 mg/ kg/ day and above were hematologic effects such as bone marrow hypocellularity, and decreased WBC, RBC and/ or platelet counts in peripheral blood.
L- aktar sejbiet komuni f’ annimali li ma kellhomx ħadid, f’ dożi ta ’ 100 mg/ kg/ kuljum u iżjed, kienu effetti ematoloġiċi bħal ipoċellularità tal- mudullun, u tnaqqis fl- għadd tal- WBC, tar- RBC u/ jew tal - plejtlits fid- demm periferali.
Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/ kg/ day or greater in non-iron-loaded animals.
L- atrofija tat- timu, tat- tessut tal- limfa, u tat- testikoli, u ipertrofija ta ’ l- adrenali, kienu rrappurtati f’ dożi ta ’ 100 mg/ kg/ kuljum jew iżjed f’ annimali li ma kellhomx ħadid.
No carcinogenicity studies in animals have been conducted with deferiprone.
7 Ma saru l- ebda studji b’ deferiprone dwar il- karċinoġeneċità fl- annimali.
The genotoxic potential of deferiprone was evaluated in a set of in vitro and in vivo tests.
Il- potenzjal ġenotossiku ta ’ deferiprone kien evalwat f’ sett ta ’ testijiet in vitro u in vivo.
Deferiprone did not show direct mutagenic properties; however, it did display clastogenic characteristics in in vitro assays and in vivo in animals.
Deferiprone ma weriex karatteristiċi mutaġeniċi diretti; madankollu wera karatteristiċi klastoġeniċi f’ assaġġi in vitro u in vivo fl- annimali.
Deferiprone was teratogenic and embryotoxic in reproductive studies in non-iron-loaded rats and rabbits at doses at least as low as 25 mg/ kg/ day.
Deferiprone kien teratoġeniku u embrijotossiku fi studji dwar ir- riproduzzjoni ta ’ firien u fniek li ma kellhomx ħadid, f’ dożi li kienu ta ’ mill- anqas 25 mg/ kg/ kuljum.
Tablet core Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Microcrystalline cellulose Magnesium stearate Colloidal silicon dioxide
Coating Hypromellose Macrogol Titanium dioxide
Kisja Hypromellose Macrogol Titanium dioxide
Do not store above 30ºC
Taħżinx f’ temperatura ’ l fuq minn 30ºC
High density polyethylene (HDPE) bottles with child resistant closure (polypropylene).
HDPE fliexken li għandhom għatjien li huma reżistenti għat- tfal.
Each pack contains one bottle of 100 tablets.
Kull pakkett fih flixkun wieħed ta ’ 100 pillola.
Darwinweg 20 2333 CR Leiden Netherlands
Darwinweg 20 2333 CR Leiden L- Olanda
25/ 08/ 1999 Date of latest renewal:
25/ 08/ 1999 Data ta ’ l- aħħar tiġdid:
Ferriprox 100 mg/ ml oral solution
Ferriprox 100 mg/ ml soluzzjoni orali
Each ml of oral solution contains 100 mg deferiprone.
Kull ml ta ’ soluzzjoni orali fih 100 mg deferiprone.
Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Kull ml ta ’ soluzzjoni orali fih 0. 4 mg Sunset Yellow (E110).
Clear, reddish orange coloured liquid.
Likwidu ta ’ lewn oranġjo ħamrani ċar.
Dose per kilogram body weight should be calculated to the nearest 2.5 ml.
Id- doża għal kull kilogramm ta ’ piż korporali għandha tiġi kkalkulata sa l- eqreb 2. 5 ml.
(see section 4.4).
Trid tingħata attenzjoni meta l- kownt assolut tan- newtrofili (absolute neutrophil count - ANC) ikun baxx, kif ukoll meta jkunu qed jiġu kkurati pazjenti b’ insuffiċjenza renali jew b’ disfunzjoni tal- fwied (ara sezzjoni 4. 4).
Dose table
Tabella tad- dożi
To obtain a dose of about 75 mg/ kg/ day, use the volume of oral solution suggested in the following table for the body weight of the patient.
Sabiex tikseb doża ta ’ madwar 75 mg/ kg/ kuljum, uża l- volum tas- soluzzjoni orali suġġerita fit- tabella li ġejja għal piż korporali tal- pazjent.
Sample body weights at 10 kg increments are listed.
10 Piż tal- Ġisem (kg)
9
Doża (mg, tliet
Body weight
ml ta ’ soluzzjoni orali (tliet darbiet/ kuljum)
ml of oral solution
500 500
times/ day) 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5
10. 0 12. 5 15. 0 17. 5 20. 0 22. 5
The risk of agranulocytosis and neutropenia is higher, if the baseline absolute neutrophil count (ANC) is less than 1.5x109/ l.
Ir- riskju ta ’ agranuloċitosi u newtropenja huwa ogħla, jekk l- għadd assolut ta ’ newtrofili (ANC) meħud bħala punt ta ’ riferiment ikun inqas minn 1. 5x109/ l.
It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to be obtained for three consecutive weeks, to ensure that the patient recovers fully.
11 CBC, tal- WBC, tan- newtrofili u tal- plejtlits, u dan għandu jibqa ’ jinkiseb kull ġimgħa għal tliet ġimgħat konsekuttivi, biex jiġi żgurat li l- pazjent jirkupra kompletament.
10 In the event of severe neutropenia or agranulocytosis:
F’ każ ta ’ newtropenja jew agranuloċitosi severa:
Excipients Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
12 Sustanzi mhux attivi Ferriprox soluzzjoni orali fih l- aġent li jlewwem Sunset Yellow (E110) li jista ’ jikkaġuna reazzjonijiet allerġiċi.
11 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 affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Increased levels of serum liver enzymes have been reported in patients taking deferiprone.
13 Livelli għolja ta ’ enzimi tas- serum fil- fwied kienu rrappurtati f’ pazjenti li kienu qed jieħdu deferiprone.
Some patients experienced progression of fibrosis associated with an increase in iron overload or hepatitis C.
Xi pazjenti ġarrbu progressjoni tal- fibrożi li kienet assoċjata ma ’ żjieda fil- livelli żejda ta ’ ħadid jew ta ’ epatite Ċ.
12 Low plasma zinc levels have been associated with deferiprone, in a minority of patients.
Livelli baxxi ta ’ żingu fil- plażma kienu assoċjati ma ’ deferiprone, f’ minoranza ta ’ pazjenti.
SYSTEM ORGAN
SISTEMA TAL- KLASSIFIKA TA ’ L- ORGANI
VERY
KOMUNI ĦAFNA (≥1/ 10)
COMMON COMMON
KOMUNI (≥1/ 100 SA < 1/ 10)
UNCOMMON
MHUX KOMUNI (≥1/ 1, 000 SA < 1/ 100)
CLASS Investigations Blood and lymphatic system disorders Nervous system disorders
Investigazzjonijiet
(≥ 1/ 10)
Żjieda fl- enzimi tal - fwied
(≥ 1/ 100 to < 1/ 10) Increased liver enzymes Neutropenia Agranulocytosis Headache
Disturbi tad- demm u tas- sistema limfatika Disturbi fis- sistema nervuża
(≥ 1/ 1,000 to < 1/ 100)
Newtropenja Agranuloċitosi Uġigħ ta ’ ras
Nausea Abdominal Pain Vomiting
Nawseja Uġigħ ta ’ żaqq Rimettar
The active substance is deferiprone (3-hydroxy-1,2-dimethylpyridin-4-one), a bidentate ligand which binds to iron in a 3:1 molar ratio.
Is- sustanza attiva hi deferiprone (3- hydroxy- 1, 2- dimethylpyridin- 4- one), ligand bidentate li jeħel mal - ħadid fi proporzjon molari ta ’ 3: 1.
13 Deferiprone has been investigated in 247 patients in two phase III trials and a compassionate use programme.
Deferiprone kien investigat f’ 247 pazjent f’ żewġ provi ta ’ fażi III u fi programm ta ’ użu compassionate.
Atrophy of the thymus, lymphoid tissues, and testis, and hypertrophy of the adrenals, were reported at doses of 100 mg/ kg/ day or greater in non-iron-loaded animals.
15 L- atrofija tat- timu, tat- tessut tal- limfa, u tat- testikoli, u ipertrofija ta ’ l- adrenali, kienu rrappurtati f’ dożi ta ’ 100 mg/ kg/ kuljum jew iżjed f’ annimali li ma kellhomx ħadid.
No carcinogenicity studies in animals have been conducted with deferiprone.
Ma saru l- ebda studji b’ deferiprone dwar il- karċinoġeneċità fl- annimali.
Purified water Hydroxyethylcellulose Glycerol Hydrochloric acid, concentrated Artificial cherry flavour Peppermint oil Sunset Yellow (E110) Sucralose (E955)
Ilma purifikat Hydroxyethylcellulose Glycerol Hydrochloric acid, konċentrat Benna artifiċjali taċ- ċirasa Żejt tal- menta Sunset Yellow (E110) Sucralose (E955)
After first opening use within 35 days.
2 snin Wara li tiftħu l- ewwel darba, uża fi żmien 35 jum.
Amber polyethylene terephthalate (PET) bottles with child resistant closure (polypropylene), and a graduated measuring cup (polypropylene).
Fliexken ambra tal- polyethylene terephthalate (PET) b’ għotjien (polypropylene) reżistenti għat- tfal, u kikkra gradata tal- kejl (polypropylene).
Each pack contains one bottle of 250 ml or 500 ml oral solution.
Kull pakkett fih flixkun wieħed ta ’ 250 ml jew 500 ml soluzzjoni orali.
Name and address of the manufacturer responsible for batch release
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Bio Science Park Archimedesweg 2 2333 CN Leiden Netherlands
Bio Science Park Archimedesweg 2 2333 CN Leiden L- Olanda
The MAH must ensure that the system of pharmacovigilance as described in version 01 (dated 4 May 2006) presented in Module 1.8.1 of the Marketing Authorisation Application is in place and functioning before and whilst the product is on the market.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza kif deskritta f’ verżjoni 01 (datata 4 ta ’ Mejju 2006) ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq qegħda f’ postha u qed tiffunzjona qabel u waqt il- prodott ikun fis- suq.
Risk Management plan
Pjan għal Ġestjoni tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan as agreed in version 2 (dated 19 September 2007) of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP
L- MAH timpenja li twettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftehma f’ verżjoni 2 (datata 19 ta ’ Settembru 2007) tal- Pjan dwar il - Ġestjoni tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni dwar l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament ieħor ta ’ l- RMP miftiehem mas- CHMP
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP dwar Sistemi ta ’ Ġestjoni ta ’ Riskju għal prodotti mediċinali għal użu mill- bniedem, RMP aġġornat għandu jiġi sottomess fl- istess żmien tar- Rapport Perijodiku dwar Aġġornament (PSUR) fuq is- Sigurtà li jkun jmiss.
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 says of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
19 Barraminhekk, RMP aġġornat għandu jiġi sottomess: • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- ispeċifikazzjoni attwali dwar is- Sigurtà, Il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jimminimizzaw ir- riskju • Fi żmien 60 jum minn meta jintlaħaq tragward importanti (farmakoviġilanza jew minimizzazzjoni ta ’ riskju) • Fuq talba ta ’ l- EMEA.
PSURs: the MAH will continue to provide Periodic Safety Update Reports every 6 months.
Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura ser ikompli jipprovdi Rapporti Perjodiċi dwar l- Aġġornament tas- Sigurtà kull 6 xhur.
18 ANNEX III
20 ANNESS III
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE OF 100 TABLETS
FLIXKUN TA ’ 100 PILLOLA
Ferriprox 500 mg film-coated tablets deferiprone
Pilloli Ferriprox ta ’ 500 mg miksija b’ rita Deferiprone
One tablet contains 500 mg deferiprone
Kull pillola fiha 500 mg ta ’ deferiprone
Film-coated tablets 100 tablets
Pilloli miksija b’ rita 100 pillola
Read the package leaflet before use.
Aqra l- fuljett fil- pakkett qabel l- użu.
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BOTTLES OF 250 ML AND 500 ML ORAL SOLUTION
FLIEXKEN TA ’ 250 ML JEW 500 ML SOLUZZJONI ORALI
Ferriprox 100 mg/ ml oral solution Deferiprone
Ferriprox 100 mg/ ml soluzzjoni orali Deferiprone
Contains Sunset Yellow (E110); see leaflet for further information.
Fih Sunset Yellow (E110); ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
250 ml oral solution 500 ml oral solution
250 ml soluzzjoni orali 500 ml soluzzjoni orali
After first opening use within 35 days.
Wara li tiftħu l- ewwel darba, uża fi żmien 35 jum.
25 PACKAGE LEAFLET:
27 FULJETT TA ’ TAGĦRIF:
Ferriprox 500 mg film-coated tablets Deferiprone
Pilloli Ferriprox ta ’ 500 mg miksija b’ rita Deferiprone
It may harm them, even if their symptoms are the same as yours. − If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. − Attached to this leaflet you will find a patient/ carer reminder card.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. − Jekk tinnota xi effetti kollaterali oħra mhux elenkati f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek. − Mehmuż ma ’ dan il- fuljett għandek ssib kard li jfakkar il- pazjent jew lil min jieħu ħsiebu.
You should detach, complete, read the card carefully and carry it with you.
Għandek tqatta ’, timla, taqra l- kard b’ attenzjoni u żżommha fuqek.
What Ferriprox is and what it is used for 2.
X’ inhu Ferriprox u għalxiex jintuża 2.
Before you take Ferriprox 3.
Qabel ma tieħu Ferriprox 3.
How to take Ferriprox 4.
Kif għandek tieħu Ferriprox 4.
How to store Ferriprox 6.
Kif taħżen Ferriprox 6.
WHAT FERRIPROX IS AND WHAT IT IS USED FOR
X’ INHU FERRIPROX U GĦALXIEX JINTUŻA
Ferriprox is a medicine that removes iron from the body.
Ferriprox hi mediċina li tneħħi l- ħadid mill- ġisem.
Deferiprone is the active substance in Ferriprox.
Deferiprone hi s- sustanza attiva f’ Ferriprox.
BEFORE YOU TAKE FERRIPROX
QABEL MA ’ TIEĦU FERRIPROX
Do not take Ferriprox − if you are allergic (hypersensitive) to deferiprone or any of the other ingredients of Ferriprox. − if you have a history of repeated episodes of neutropenia (low neutrophil count). − if you have a history of agranulocytosis (very low white blood cell count < 0.5x109/ l). − if you are currently taking medicines known to cause neutropenia. − if you are pregnant or breast-feeding.
Tieħux Ferriprox − jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal deferiprone jew sustanzi oħra ta ’ Ferriprox. − jekk għandek passat ta ’ episodji ripetuti ta ’ newtropenja (kownt baxx ta ’ newtrofili). − jekk għandek passat ta ’ agranuloċitosi (kownt baxx ħafna ta ’ ċelluli bojod tad- demm < 0. 5x109/ l). − jekk attwalment qed tieħu xi mediċini magħrufa li jikkaġunaw newtropenja. − jekk inti tqila jew qed tredda ’
Therapy with Ferriprox may be associated with the occurrence of a very low white blood cell count in some patients.
It- terapija b’ Ferriprox tista ’ tkun assoċjata ma ’ l- okkorrenza ta ’ kownt baxx ħafna ta ’ ċelluli bojod tad - demm f’ xi pazjenti.
This condition is known as severe neutropenia or agranulocytosis and may place you at risk of developing a serious infection.
Din il- kundizzjoni hi magħrufa bħala newtropenja severa jew agranuloċitosi u tista ’ tpoggik f’ riskju li tiżviluppa infezzjoni serja.
The way Ferriprox causes neutropenia is not known.
Il- mod Ferriprox jikkawża neutropenja mhux magħruf.
Patients must not take any medicines known to be associated with neutropenia or those that can cause agranulocytosis.
Pazjenti m’ għandhomx jieħdu mediċini magħrufa li huma assoċjati ma ’ newtropenja jew dawk li jistgħu jikkawżaw agranuloċitosi.
Take special care with Ferriprox − if you have a history of neutropenia, since one of the most serious side effects that may occur is a very low white blood cell (neutrophil) count.
Oqgħod attent ħafna b’ Ferriprox − jekk għandek passat ta ’ newtropenja, għax wieħed mill- aktar effetti sekondarji serji li jistgħu jseħħu hu kownt baxx ħafna ta ’ ċelluli bojod tad- demm (newtrofili) tad- demm.
This condition, known as severe neutropenia or agranulocytosis, has occurred in about 1 out of 100 people who have taken Ferriprox in clinical studies.
Din il - kundizzjoni, magħrufa bħala newtropenja severa jew agranuloċitosi, seħħet f’ madwar 1 minn kull 100 ruħ li ħadu Ferriprox fi studji kliniċi.
It is very important for you to keep all of these appointments.
Minħabba li ċ- ċelluli bojod jgħinu biex jiġġieldu kontra l- infezzjoni, il- kownt baxx ta ’ newtrofili jista ’ jpoġġik f’ riskju li tiżviluppa infezzjoni serja li potenzjalment tista ’ tkun ta ’ periklu għall- ħajja.
Please refer to the patient/ carer
Biex jiċċekkja għan- newtropenja, it -
Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
28 It- tabib tiegħek għandu wkoll jagħtik parir biex tmur għal testijiet biex tiċċekkja il- ħażna ta ’ ħadid fil - ġisem.
In addition he or she also might ask you to undergo liver biopsies.
Ma ’ dan, hu jew hi jista ’ / tista ’ jitolbok/ titolbok biex tagħmel xi bijopsiji tal- fwied.
Taking other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Jekk jogħġbok ikkonsulta mat- tabib jew ma ’ l- ispiżjar tiegħek qabel ma ’ tieħu vitamina Ċ ma ’ Ferriprox.
Do not take aluminium-based antacids while taking Ferriprox.
Tiħux antaċidi bbażati fuq l- aluminju waqt li tkun qed tieħu Ferriprox.
Do not take medicines known to cause neutropenia (see section “ Do not take Ferriprox ”).
M’ għandekx tieħu mediċini li huma magħrufa li jikkawżaw newtropenja (ara s - sezzjoni “ Tieħux Ferriprox ”).
Pregnancy and breast feeding Do not take this medicine if you are pregnant or if you are trying to become pregnant.
Tqala u treddigħ M’ għandekx tieħu din il- mediċina jekk inti tqila jew jekk qed tipprova tinqabad tqila.
This medicine could seriously harm your baby.
Din il- mediċina tista ’ tagħmel ħsara serja lit- tarbija tiegħek.
You must use effective contraception while you are taking Ferriprox.
Għandek tuża kontraċezzjoni effettiva waqt li tkun qed tieħu Ferriprox.
Ask your doctor which method is best for you.
Staqsi lit- tabib tiegħek liema hu l- aħjar metodu għalik.
If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.
Jekk toħroġ tqila waqt li tkun qed tieħu Ferriprox, ieqaf immedjatament milli tieħu din il- mediċina u għid lit- tabib tiegħek.
Do not use Ferriprox if you are a nursing mother.
Tużax Ferriprox jekk inti omm li qed tredda ’.
Please refer to the patient/ carer reminder card attached to this leaflet.
Jekk jogħġbok irreferi għal kard tal- pazjent/ min jieħu ħsiebu mehmuża ma ’ dan il- fuljett.
HOW TO TAKE FERRIPROX
KIF GĦANDEK TIEĦU FERRIPROX
Always take Ferriprox exactly as your doctor has told you.
Dejjem għandek tieħu Ferriprox skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar jekk ikollok xi dubju.
The amount of Ferriprox that you take will depend on your weight.
L- ammont ta ’ Ferriprox li inti tieħu jiddependi mill- piż tiegħek.
The usual dose is 25 mg/ kg, 3 times per day, for a total daily dose of 75 mg/ kg/ day.
Id- doża normali hi ta ’ 25 mg/ kg, 3 darbiet kuljum, għal doża totali ta ’ 75 mg/ kg/ kuljum.
The total daily dose should not exceed 100 mg/ kg/ day.
Id- doża totali ta ’ kuljum m’ għandhiex taqbeż il- 100 mg/ kg/ kuljum.
Take your first dose in the morning.
Ħu l- ewwel doża tiegħek filgħodu.
Take your second dose midday.
Ħu t- tieni doża tiegħek f’ nofsinhar.
Take your third dose in the evening.
Ħu t- tielet doża tiegħek filgħaxija.
It is not necessary to take Ferriprox with food.
Mhux meħtieġ li tieħu Ferriprox ma ’ l - ikel.
However, you may find it easier to remember to take Ferriprox if you take it with your meals.
Madankollu, għandek mnejn issibha aktar faċli tiftakar biex tieħu Ferriprox jekk tieħdu ma ’ l - ikliet tiegħek.
If you take more Ferriprox than you should There are no reports of acute overdose with Ferriprox.
M’ hemmx rapporti ta ’ doża eċċessiva b’ Ferriprox.
If you have accidentally taken more than the prescribed dose, you should contact your doctor.
Jekk tkun ħadt aċċidentalment aktar mid- doża ta ’ Ferriprox li għaliha ngħatajt riċetta, għandek tikkuntattja lit- tabib tiegħek.
If you forget to take Ferriprox Ferriprox will be most effective if you do not miss any doses.
Ferriprox ikun l- aktar effettiv jekk ma tinsiex tieħu xi dożi.
If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time.
Jekk tinsa tieħu xi doża, ħudha hekk kif tiftakar u ħu d- doża li jmiss fil- ħin regolari skedat tagħha.
If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule.
Jekk tinsa tieħu aktar minn doża waħda, m’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu, imma kompli bl- iskeda normali tiegħek.
Do not change your daily dose without first talking to your doctor.
Tbiddilx id- doża tiegħek ta ’ kuljum qabel ma tkellem lit- tabib tiegħek.
Like all medicines, Ferriprox can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Ferriprox jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (more than 1 in 10 patients):
Effetti kollaterali komuni ħafna (aktar minn pazjent 1 f’ kull 10):
Abdominal pain, nausea, vomiting, and reddish/ brown discolouration of urine.
Uġigħ addominali, dardir, remettar, kulur ta ’ l- awrina fl- aħmar/ kannella.
If you experience nausea or vomiting, it may help to take your Ferriprox with some food.
29 Jekk tħossok mdardar jew trid tirremetti, għandu mnejn jgħinek jekk tieħu l- Ferriprox ma ’ xi ikel.
Discoloured urine is a very common effect and is not harmful.
Awrina b’ kulur mhux tas- soltu hu effett komuni ħafna u mhuwiex ta ’ periklu.
Common side effects (more than 1 in 100, fewer than 1 in 10 patients):
Effetti kollaterali komuni (aktar minn pazjent 1 f’ 100, inqas minn 1 f’ 10):
Low white blood cell count (agranulocytosis and neutropenia), headache, diarrhoea, increase in liver enzymes, fatigue, increase in appetite.
Għadd baxx ta ’ ċelluli bojod tad- demm (agranuloċitosi u newtropenja), uġigħ ta ’ ras, dijarea, żieda fl- enżimi tal- fwied, għeja, żieda fl- aptit.
27 The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
L- aktar effett kollaterali serju ta ’ Ferriprox hu l- għadd baxx ħafna ta ’ ċelluli bojod tad- demm (newtrofili).
This condition, known as severe neutropenia or agranulocytosis, has occurred in fewer than 2 in 100 people who have taken Ferriprox in clinical studies.
Din il- kundizzjoni, magħrufa bħala newtropenja jew agranuloċitosi seħħet f’ inqas minn 2 f’ kull 100 persuna li ħadu Ferriprox fl- istudji kliniċi.
A low white blood cell count can be associated with a serious and potentially life-threatening infection.
Għadd baxx ta’ ċ elluli tad- demm bojod jista ’ jkun assoċjat ma ’ infezzjoni serja jew li potenzjalment hi ta ’ periklu għal ħajja.
Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.
Irraporta minnufih lit - tabib tiegħek kull sintomu ta ’ infezzjoni bħal: deni, uġigħ fil- griżmejn jew sintomi bħal ta ’ l - influwenza.
Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Każijiet bħal uġigħ fil- ġogi u nefħa kienu jvarjaw minn uġigħ ħafif f’ ġog wieħed jew aktar għal diżabilità severa.
In most cases, the pain disappeared while patients continued taking Ferriprox.
F’ ħafna każijiet, l- uġigħ sparixxa waqt li l- pazjenti baqgħu jieħdu Ferriprox.
In post-marketing experience with Ferriprox, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/ kg/ day for several years.
Fl- esperjenza ta ’ wara t- twegħid fis- suq, disturbi newroloġiċi (bħal rogħda, disturbi fil- mod kif timxi, tara doppju, kontrazzjonijiet involontarji tal- muskoli, problemi fil- koordinazzjoni tal- moviment) kienu rrappurtati fi tfal li, b’ mod voluntarju, ingħataw riċetta li kienet aktar mid- doppju tad- doża massima rrakkomandata ta ’ 100 mg/ kg/ jum għal diversi snin.
They recovered from these symptoms after Ferriprox discontinuation.
Huma rkupraw minn dawn is- sintomi wara li Ferriprox twaqqaf.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE FERRIPROX
KIF TAĦŻEN FERRIPROX
Do not use Ferriprox after the expiry date which is stated on the carton and the label after EXP.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal Tużax Ferriprox wara d- data ta ’ skadenza li tidher fuq it- tikketta u il- kartuna wara EXP.
Do not store above 30ºC.
Taħżinx f’ temperatura ’ l fuq minn 30ºC
Each tablet contains 500 mg deferiprone.
X’ fih Ferriprox Is- sustanza attiva hi deferiprone Kull pillola fiha 500 mg ta ’ deferiprone
Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.
Hypromellose, Macrogol, Titanium dioxide.
Hypromellose, Macrogol, Titanium dioxide.
What Ferriprox looks like and contents of the pack Ferriprox tablets are white to off-white, capsule-shaped, film-coated tablets imprinted “ APO” bisect “ 500” on one side, plain on the other.
Id- Dehra ta ’ Ferriprox u d- daqs tal- pakkett Il- pilloli Ferriprox huma ta ’ lewn abjad jew abjad jagħti fil- griż, li għandhom forma ta ’ kapsula, miksija b’ rita, li għandhom stampat fuqhom “ APO ” b’ qasma fin- nofs u “ 500 ” fuq naħa waħda, u xejn fuq in- naħa l- oħra.
The tablets are scored and breakable in half.
Il- pilloli għandhom ferq u jistgħu jinqasmu min- nofs.
Ferriprox is packaged in bottles of 100 tablets.
Ferriprox hu ppakkjat fi fliexken ta ’ 100 pillola.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
30 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Manufacturing Authorisation Holder:
Il- Manifattur:
For any information about this medicine, 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:
Ísland SWEDISH ORPHAN A/ S Sími: + 45 32 96 68 69
31 Slovenská republika Ísland SWEDISH ORPHAN A/ S Sími: + 45 32 96 68 69
This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar f ’.
30 PACKAGE LEAFLET:
32 FULJETT TA ’ TAGĦRIF:
Before you take Ferriprox 3.
X’ inhu Ferriprox u għalxiex jintuża 2 Qabel ma tieħu Ferriprox 3.
Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection.
Biex jiċċekkja għan- newtropenja, it -
To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox.
33 tabib tiegħek ser jagħtik parir biex tagħmel test tad- demm (sabiex jiċċekkja l- kownt ta ’ ċelluli bojod fid- demm) b’ mod regolari, anke bil- frekwenza ta ’ wieħed fil- ġimgħa, waqt li tkun qed tieħu t- trattament b’ Ferriprox.
It is very important for you to keep all of these appointments.
Hu importanti ħafna għalik li żżomm dawn l- appuntamenti kollha.
Please refer to the patient/ carer
Jekk jogħġbok irreferi għal kard tal- pazjent/ min jieħu ħsiebu mehmuża ma ’ dan il - fuljett.
Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
Irrapporta immedjatament lit- tabib tiegħek kwalunkwe sintomi ta ’ infezzjoni bħal deni, uġigħ fil- griżmejn u sintomi bħal dawk ta ’ l- influwenza.
Your doctor will also ask you to come in for tests to monitor body iron load.
It- tabib tiegħek għandu wkoll jagħtik parir biex tmur għal testijiet biex tiċċekkja il- ħażna ta ’ ħadid fil - ġisem.
Do not take medicines known to cause neutropenia (see section “ Do not take Ferriprox”).
M’ għandekx tieħu mediċini li huma magħrufa li jikkawżaw newtropenja (ara s - sezzjoni “ Tieħux Ferriprox ”).
Important information about some of the ingredients of Ferriprox Ferriprox oral solution contains Sunset Yellow (E110) which may cause allergic reactions.
Tagħrif importanti dwar xi wħud mis- sustanzi li jinsabu f’ Ferriprox Is- soluzzjoni orali Ferriprox fiha Sunset Yellow (E110) li jista ’ jikkawża reazzjonijiet allerġiċi.
Use the measuring cup to measure the volume prescribed by your doctor.
Uża l- kikkra tal- miżura bħala miżura biex tkejjel il- volum preskritt mit- tabib tiegħek.
It is not necessary to take Ferriprox with food.
Mhux meħtieġ li tieħu Ferriprox ma ’ l- ikel.
However, you may find it easier to remember to take Ferriprox if you take it with your meals.
Madankollu, għandek mnejn issibha aktar faċli tiftakar biex tieħu Ferriprox jekk tieħdu ma ’ l- ikliet tiegħek.
If you take more Ferriprox than you should There are no reports of acute overdose with Ferriprox.
Jekk tieħu aktar Ferriprox milli suppost għandek M’ hemmx rapporti ta ’ doża eċċessiva b’ Ferriprox.
If you forget to take Ferriprox Ferriprox will be most effective if you do not miss any doses.
Jekk tinsa tieħu Ferriprox Ferriprox ikun l- aktar effettiv jekk ma tinsiex tieħu xi dożi.
Very common side effects (more than 1 in 10 patients):
34 Effetti kollaterali komuni ħafna (aktar minn pazjent 1 f’ kull 10):
If you experience nausea or vomiting, it may help to take your Ferriprox with some food.
Jekk tħossok mdardar jew trid tirremetti, għandu mnejn jgħinek jekk tieħu l- Ferriprox ma ’ xi ikel.
32 Common side effects (more than 1 in 100, fewer than 1 in 10 patients):
Effetti kollaterali komuni (aktar minn pazjent 1 f’ 100, inqas minn 1 f’ 10):
The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
L- aktar effett kollaterali serju ta ’ Ferriprox hu l- għadd baxx ħafna ta ’ ċelluli bojod tad- demm (newtrofili).
Store in the original package in order to protect from light.
Taħżinx f’ temperatura ’ l fuq minn 30ºC Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
What Ferriprox contains The active substance is deferiprone.
X’ fih Ferriprox Is- sustanza attiva hi deferiprone.
The other ingredients are: purified water; hydroxyethylcellulose; glycerol; hydrochloric acid, concentrated; artificial cherry flavour; peppermint oil; Sunset Yellow (E110); sucralose (E955).
Is- sustanzi l- oħra huma: ilma purifikat; hydroxyethylcellulose; glycerol; hydrochloric acid, konċentrat; benna artifiċjali taċ- ċirasa; żejt tal- menta; Sunset Yellow (E110); sucralose (E955).
What Ferriprox looks like and contents of the pack Ferriprox oral solution is a clear, reddish orange coloured liquid.
Id- Dehra ta ’ Ferriprox u d- daqs tal- pakkett Is- soluzzjoni orali Ferriprox hija likwidu ċar, ta ’ lewn oranġjo ħamrani.
It is packaged in bottles of 250 ml or 500 ml.
Hi tiġi ppakkjata fi fliexken ta ’ 250 ml jew 500 ml.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
35 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
España Swedish Orphan International S. L Tel: + 34 913 91 35 80
Portugal España Swedish Orphan International S. L Tel: + 34 913 91 35 80
Portugal SWEDISH ORPHAN INTERNATIONAL AB Tel: + 351 21 383 08 91
SWEDISH ORPHAN INTERNATIONAL AB Tel: + 351 21 383 08 91
Ísland SWEDISH ORPHAN A/ S Sími: + 45 32 96 68 69
36 Slovenská republika Ísland SWEDISH ORPHAN A/ S Sími: + 45 32 96 68 69
35 PATIENT/ CARER REMINDER CARD
37 KARD TA ’ TFAKKIR TAL- PAZJENT/ PERSUNA LI TIEĦU ĦSIEB
Important Safety Reminders for Patients taking Ferriprox (deferiprone)
((Qoxra ta ’ wara)) ((Qoxra ta ’ Quddiem))
FOR WOMEN OF CHILD BEARING AGE Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
GĦAL NISA LI JISTA ’ JKOLLHOM IT - Punti ta ’ Tifkir dwar Sigurtà Importanti għal TFAL Pazjenti li qed jieħdu M’ għandekx tieħu Ferriprox jekk inti tqila Ferriprox (deferiprone) jew qed tipprova tinqabad tqila.
If taken
Jekk tieħdu
Prescribing doctor: ________________________
Tabib li jippreskrivi: ________________________ Nru tat -
during pregnancy, Ferriprox may seriously harm the unborn baby.
waqt it- tqala, Ferriprox jista ’ jagħmel ħsara serja lit- tarbija mhix mwielda.
You must use effective contraception while you are taking Ferriprox.
Għandek tuża kontraċezzjoni effettiva waqt li qed tieħu Ferriprox.