qanastek/EMEA-V3 huggingface dataset:
Limited pharmacokinetic and/ or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted.
Saru għadd limitat ta ’ studji farmakokinetiċi u/ jew farmakodinamiċi li jistħarrġu r- reazzjonijiet possibbli bejn anagrelide u prodotti mediċinali oħrajn.
Drug interactions: effects of other substances on anagrelide • Anagrelide is primarily metabolised by CYP1A2.
Interazzjonijiet mediċinali: effetti ta ’ sustanzi oħrajn fuq anagrelide: • Anagrelide huwa metabolizzat primarjament minn CYP1A2.
It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine and omeprazole, and such medicinal products could theoretically adversely influence the clearance of anagrelide. • In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the pharmacokinetic properties of anagrelide.
Huwa magħruf li CYP1A2 huwa impedut minn diversi prodotti mediċinali, li jinkludu fluvoxamine u omeprazole, u prodotti mediċinali bħal dawn jistgħu teoritikament jinfluwenzaw b' mod ħażin ir- rata ta 'l - eliminazzjoni ta ’ anagrelide. • Studji ta ’ interazzjonijet in vivo fil- bnedmin urew li digoxin u warfarin ma jaffetwawx il - kwalitajiet farmakokinetiċi ta ’ anagrelide.
Drug interactions: effects of anagrelide on other substances • Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism e. g. theophylline. • Anagrelide is an inhibitor of PDE III.
Interazzjonijiet mediċinali: effetti ta ’ anagrelide fuq sustanzi oħrajn: • Anagrelide juri xi attività inibitorja limitata lejn CYP1A2 li tista ’ tippreżenta potenzjal teoretiku għal interazzjonijiet ma ’ prodotti mediċinali oħrajn mogħtija flimkien li għandhom l - istess mekkaniżmu ta ’ eliminazzjoni eż. theophylline. • Anagrelide huwa impeditur ta ’ PDE III.
The effects of medicinal products with similar properties such as the inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by anagrelide. • In vivo interaction studies in humans have demonstrated that anagrelide does not affect the pharmacokinetic properties of digoxin or warfarin. • At the doses recommended for use in the treatment of essential thrombocythaemia, anagrelide may theoretically potentiate the effects of other medicinal products that inhibit or modify platelet function e. g. acetylsalicylic acid. • A clinical interaction study performed in healthy subjects showed that co-administration of repeat-dose anagrelide 1mg once daily and acetylsalicylic acid 75mg once daily may enhance the anti-platelet aggregation effects of each drug compared with administration of acetylsalicylic acid alone.
L- effetti ta ’ prodotti mediċinali bi kwalitajiet simili bħall- inotropi milrinone, enoximone, amrinone, olprinone u cilostazol jistgħu jiħraxu permezz ta ’ anagrelide. • Studji ta ’ interazzjonijiet in vivo fil- bnedmin urew li anagrelide ma jaffettwax il- kwalitajiet farmakokinetiċi ta ’ digoxin jew warfarin. • Fid- dożi rakkomandati għal użu fit- trattament ta ’ tromboċitemja essenzjali, anagrelide jista ’ teoritikament iqawwi l- effetti ta ’ prodotti mediċinali oħra li jimpedixxu jew jimmodifikaw il - funzjoni tal- plejtlets eż. acetylsalicylic acid. • Studju dwar interazzjoni klinika li sar fuq persuni b’ saħħithom wera li l- għoti flimkien ta ’ doża ripetuta ta ’ anagrelide 1mg darba kuljum u acetylsalicylic acid 75mg darba kuljum jista ’ jtejjeb l- effetti tal- aggregazzjoni tal- anti- plejtlits ta ’ kull mediċina meta mqabbel mal- għoti ta ’ acetylsalicylic acid waħdu.
Therefore, due to the lack of data in ET patients, the potential risks of the concomitant use of anagrelide with acetylsalicylic acid should be assessed, particularly in patients with a high risk profile for haemorrhage before treatment is initiated. • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Għalhekk, minħabba n- nuqqas ta ’ dejta f’ pazjenti ET, ir- riskji potenzjali tal- użu fl- istess ħin ta ’ anagrelide ma ’ acetylsalicylic acid għandhom jiġu evalwati, partikularment f’ pazjenti bi profil ta ’ riskju għoli għal emorraġija qabel tinbeda l- kura. • Anagrelide jista ’ jikkaġuna disturbi intestinali f ’ xi pazjenti u jikkomprometti l- assorbiment ta ’ kontraċettivi ormonali orali.
Food interactions: • Food delays the absorption of anagrelide but does not significantly alter systemic exposure. • The effects of food on bioavailability are not considered clinically relevant to the use of anagrelide.
Interazzjonijiet ma ’ l- ikel: • L- ikel idewwem l- assorbiment ta ’ anagrelide imma ma jbiddilx b’ mod sinifikanti l - espożizzjoni sistemika. • L- effetti ta ’ l- ikel fuq il- bijodisponibiltà mhumiex ikkunsidrati li huma klinikament rilevanti għall- użu ta ’ angrelide.
There are no adequate data from the use of anagrelide in pregnant women.
M' hemmx biżżejjed tagħrif dwar l- użu ta 'anagrelide f' nisa tqal.
The potential risk for humans is unknown.
Ir- riskju li jista 'jkun hemm għall- bniedem m' huwiex magħruf.
4 Use of Xagrid during pregnancy is not recommended.
4 L- użu ta 'Xagrid waqt it- tqala mhux rakkomandat.
If Xagrid is used during pregnancy, or if the patient becomes pregnant while using the drug, she should be advised of the potential risk to the foetus.
Jekk Xagrid jintuża waqt it- tqala, jew jekk il - pazjenta toħroġ tqila waqt li tkun qed tuża l- mediċina, għandha tiġi avżata dwar ir- riskju potenzjali għall- fetu.
Women of child-bearing potential should use adequate birth-control measures during treatment with anagrelide.
Nisa li jista 'jkollhom it- tfal għandhom jużaw miżuri xierqa ta' kontraċezzjoni waqt it- trattament b' anagrelide.
It is not known whether anagrelide hydrochloride is excreted in milk.
M' huwiex magħruf jekk anagrelide hydrochloride joħroġx fil- ħalib tal- bniedem.
Since many medicinal products are excreted in human milk and because of the potential for adverse reactions in breast-feeding infants, mothers should discontinue breast-feeding when taking Xagrid.
Peress li ħafna prodotti mediċinali huma eliminati fil- ħalib uman u minħabba r- riskju potenzjali ta ’ reazzjonijiet avversi fi trabi li jkunu qegħdin jiġu mredda`, l- ommijiet għandhom iwaqqfu t- treddigħ meta jkunu qed jieħdu Xagrid.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u t- tħaddim ta ’ magni.
In clinical development, dizziness was commonly reported.
Fl- iżvilupp kliniku, l - isturdamenti kienu rrapportati ta 'spiss.
Patients are advised not to drive or operate machinery while taking Xagrid if dizziness is experienced.
Il- pazjenti għandhom jiġu avżati biex ma jsuqux jew iħaddmu inġenji meta jkunu qed jieħdu Xagrid jekk ikollhom isturdament.
The safety of anagrelide has been examined in 4 open label clinical studies.
Is- sigurtà ta 'anagrelide ġiet eżaminata f' 4 studji kliniċi open label.
In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2mg/ day were assessed for safety.
Fi 3 mill- istudji 942 pazjent li rċevew anagrelide f' doża medja ta 'madwar 2mg/ jum ġew assessjati għas- sigurà.
In these studies 22 patients received anagrelide for up to 4 years.
F' dawn l- istudji 22 pazjent irċevew anagrelide sa 4 snin.
In the later study 3660 patients who received anagrelide at a mean dose of approximately 2mg/ day were assessed for safety.
Fi studju li sar aktar tard 3660 pazjent li rċevew anagrelide f' doża medja ta 'madwar 2mg/ jum ġew assessjati għas- sigurà.
In this study 34 patients received anagrelide for up to 5 years.
F' dan l- istudju 34 pazjent irċevew anagrelide sa 5 snin.
The most commonly reported drug related adverse reactions were headache occurring at approximately 14%, palpitations occurring at approximately 9%, fluid retention and nausea both occurring at approximately 6%, and diarrhoea occurring at 5%.
L- aktar reazzjoni avversa komuni relatat mal- mediċina rrapportata kienet l- uġigħ ta 'ras li seħħet f' madwar 14%, palpitazzjonijiet li seħħew, f' madwar 9%, akkumulazzjoni ta' fluwidu u nawsja li t - tnejn seħħew f' madwar 6%, u dijarea li seħħet f' 5%.
These adverse drug reactions are expected based on the pharmacology of anagrelide (inhibition of PDE III).
Dawn ir- reazzjonijiet avversi tal- mediċina huma mistennija skond il- farmakoloġija ta 'anagrelide (inpediment ta' PDE III).
Gradual dose titration may help diminish these effects (see section 4.2).
Titrazzjoni gradwali tad - doża tista 'tgħin biex tnaqqas dawn l- effetti (ara sezzjoni 4. 2).
The following convention was used for frequency of adverse drug reactions: very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1 ,000, < 1/100); rare (> 1/10,000, < 1/ 1,000); not known (cannot be estimated from the available data).
Il- konvenzjoni li ġejja ntużat għall- frekwenza ta 'reazzjonijiet avversi tal- mediċina: komuni ħafna (> 1/ 10) komuni (> 1/ 100, < 1/ 10) mhux komuni (> 1/ 1, 000, < 1/ 100) rari (> 1/ 10, 000, < 1/ 1, 000); mhux magħrufa (ma tistax issir stima mill- informazzjoni disponibbli).
Uncommon:
Disturbi fid- demm u fis- sistema limfatika Komuni:
Anaemia Thrombocytopenia, pancytopenia, ecchymosis, haemorrhage
Anemija
Fluid retention Oedema, weight loss Weight gain
Tromboċitopenja, panċitopenja, ekċimosi, emorraġija
Headache Common:
Disturbi fil -- metabolizmu u n- nutrizzjon:
Dizziness Paraesthesia, insomnia, depression, confusion, hypoaesthesia, nervousness, dry mouth, amnesia
Akkumulazzjoni ta’ fluwidu
Somnolence, abnormal coordination, dysarthria, migraine
Uġigħ ta 'ras Komuni:
Special senses
Sturdament.
Vision abnormal, tinnitus, diplopia
Vista anormali, tinnite, diplopja
Palpitations, tachycardia
Palpitazzjonijiet, takikardja
Angina pectoris, myocardial infarction, cardiomegaly, cardiomyopathy, pericardial effusion, vasodilatation, postural hypotension
Angina pektoris, infart mijokardijaku, kardjomegalija, kardjomijopatija, effużjoni perikardjali, twessigħ tal- vażi, pressjoni baxxa minħabba l- qagħda
Respiratory and thoracic disorders Uncommon:
Disturbi respiratorji u toraċiċi Mhux komuni:
Not known:
Dispneja, epistassi, effużjoni plewrali, pnewmonja Rari:
Dyspnoea, epistaxis, pleural effusion, pneumonia Pulmonary hypertension, pulmonary infiltrates Allergic alveolitis
Alveolite allerġika
Gastrointestinal disorders Common:
Disturbi gastrointestinali Komuni:
Nausea, diarrhoea, abdominal pain, flatulence, vomiting Dyspepsia, anorexia, pancreatitis, constipation, gastrointestinal haemorrhage, gastrointestinal disorder
Nawsja, dijarrea, uġigħ addominali, gass, rimettar
Colitis, gastritis, gingival bleeding
Kolite, gastrite, fsada fil- ħanek
Hepatic enzymes increased
Disturbi fil- ġilda u fit - tessuti taħtha Komuni:
Uncommon:
Raxx
Rash Alopecia, skin discoloration, pruritus Dry skin
Alopeċja, tibdil fil- kulur tal- ġilda, prurite Rari:
Musculoskeletal and connective tissue disorders Uncommon:
Disturbi muskolu- skeltrali u tat- tessut konnettiv Mhux komuni:
Myalgia, arthralgia, back pain
Uġigħ fil- muskoli, artralġja, uġigħ fid- dahar
Uncommon:
Uroġenitali Mhux komuni:
Rare:
Impotenza Rari:
Impotence Nocturia, renal failure
Notturja, insuffiċjenza renali
Investigations Rare:
Investigazzjonijiet Rari:
Blood creatinine increased
Żieda fil- krejatinina fid- demm
Uncommon:
Għeja
Fatigue Chest pain, weakness, chills, malaise, fever Asthenia, pain, flu-like syndrome
Astenja, uġigħ, sindromu li jixbaħ lir- riħ / influwenza
There have been a small number of post-marketing case reports of intentional overdose with anagrelide.
Kien hemm għadd żgħir ta ’ rapporti ta ’ wara t- tqegħid fis- suq dwar dożaġġ eċċessiv intenzjonali b’ anagrelide.
Reported symptoms include sinus tachycardia and vomiting.
Sintomi rrapportati jinkludu sinus, takikardja u rimettar.
Symptoms resolved with conservative management.
Is- sintomi ġew riżolti b’ manigment konservattiv.
A specific antidote for anagrelide has not been identified.
Ma ġie indentifikat l- ebda antidot għal anagrelide.
In case of overdose, close clinical supervision of the patient is required; this includes monitoring of the platelet count for thrombocytopenia.
F’ każ ta ’ doża eċċessiva, sorveljanza klinika mill - qrib hija meħtieġa; din tinkludi monitoraġġ ta ’ l- għadd tal- plejtlets għat- tromboċitopenja.
Dosage should be decreased or stopped, as appropriate, until the platelet count returns to within the normal range.
Id- dożaġġ għandu jitnaqqas jew jitwaqqaf, kif suppost, sakemm l- għadd tal- plejtlets jerġa 'jiġi fil- livelli normali.
Xagrid, at higher than recommended doses, has been shown to produce reductions in blood pressure with occasional instances of hypotension.
F’ dożi aktar għoljin minn dawk rrakkomandati, Xagrid wera li jikkaġuna tnaqqis fil- pressjoni tad - demm u kultant anke każijiet ta ’ pressjoni baxxa.
A single 5mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
Doża waħdanija ta ’ 5mg anagrelide tista ’ tikkaġuna twaqqigħ fil- pressjoni tad- demm li ġeneralment tkun akkompanjata bi sturdament.
PHARMACOLOGICAL PROPERTIES
6 Kodiċi ATC:
L01XX35 (Other Antineoplastic Agents)
L01XX35 (Sustanzi Antineoplastiċi oħrajn)
The specific mechanism of action by which anagrelide reduces platelet count is not yet fully understood although it has been confirmed that anagrelide is platelet selective from in vitro and in vivo study information.
Il- mekkaniżmu ta ’ azzjoni speċifika li bih anagrelide jnaqqas l- għadd tal- plejtlets s’ issa mhux mifhum kompletament għalkemm ġie konfermat minn informazzjoni ta ’ studji in vitro u in vivo li anagrelide huwa selettiv għal plejtlets.
In vitro studies of human megakaryocytopoiesis established that anagrelide’ s inhibitory actions on platelet formation in man are mediated via retardation of maturation of megakaryocytes, and reducing their size and ploidy.
Studji in vitro ta ’ megakarjoċitopoeżi umana stabbilixxew li l- azzjonijiet inibitorji ta ’ anagrelide fuq il- formazzjoni tal- plejtlets fil- bniedem huma medjati permezz ta ’ dewmien fil- maturazzjoni tal - megakarjoċiti, u bi tnaqqis tad- daqs u l- ploidy tagħhom.
Evidence of similar in vivo actions was observed in bone marrow biopsy samples from treated patients.
Evidenza ta ’ azzjonijiet simili in vivo kienet osservata f’ kampjuni tal- bijopsiji mill- mudullun ta ’ pazjenti trattati.
Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
Anagrelide huwa impeditur ta ’ cyclic AMP phosphodiesterase III.
The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four open- label, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative disorders (MPDs).
Is- sigurtà u l- effikaċja ta ’ anagrelide bħala mediċina li tbaxxi l- għadd tal- plejtlets kienu evalwati f’ erba ’ provi kliniċi open- label u mhux ikkontrollati (in- numri ta 'l- istudji 700- 012, 700- 014, 700- 999 u 13970- 301) li nkludew aktar minn 4000 pazjent b’ disturbi majeloproliferattivi (MPDs).
In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x 109/ l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
F’ pazjenti b’ tromboċitemja essenzjali, respons komplut kien definit bħala tnaqqis fl- għadd tal- plejtlets għal ≤600 x 109/ l jew tnaqqis ta ’ ≥50% mil- linja bażi ta 'riferimet u tat- tnaqqis jibqa ’ għal ta ’ l- anqas 4 ġimgħat.
In studies 700- 012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
Il- ħin biex jintlaħaq respons komplut fl- istudji 700- 012, 700- 014, 700- 999 u l- istudju 13970- 301varja minn 4 sa 12- il ġimgħa.
Clinical benefit in terms of thrombohaemorrhagic events has not been convincingly demonstrated.
Ma ġiex muri b’ konvinzjoni s- siwi kliniku f’ termini ta ’ reazzjonijiet tromboemorraġiċi.
An open label clinical study with a 3 month treatment period did not raise any safety concerns for anagrelide in 17 children/ adolescent patients with ET (age range 7-14 years) compared to 18 adult patients.
Studju kliniku, open label b’ perijodu ta ’ trattament ta ’ 3 xhur ma qajjimx tħassib dwar is- sigurtà ta ’ anagrelide fi 17- il tifel jew tifla/ adolexxenti b’ ET (età ta ’ bejn is- 7 u l- 14- il sena) meta mqabbel ma ’ 18- il pazjent adult.
Earlier during clinical development a limited number (12) of children (age range 5 - 17 years) with essential thrombocythaemia were treated with anagrelide.
Aktar kmieni fi żvilupp kliniku għadd limitat (12) ta ’ tfal (età ta ’ bejn il- 5 u s- 17- il sena) bi tromboċitemja essenzjali kienu ttrattati b’ anagrelide.
Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract.
Wara l- għoti orali ta ’ anagrelide fil- bniedem, ta ’ l- anqas 70% jiġi assorbit mill- passaġġ gastrointestinali.
In fasted subjects, peak plasma levels occur about 1 hour after a 0.5mg dose; the plasma half- life is short, approximately 1.3 hours.
F’ individwi sajmin, il- livelli massimi fil- plażma jseħħu f' madwar siegħa wara doża ta ’ 0. 5mg; il- half- life fil- plażma hija qasira, madwar 1. 3 sigħat.
Dose proportionality has been found in the dose range 0.5mg to 2mg.
Il- proporzjonalità fid- doża nstabet f’ doża li tvarja minn 0. 5mg sa 2mg.
Anagrelide is primarily metabolised by CYP1A2; less than 1% is recovered in the urine as anagrelide.
Anagrelide huwa primarjament metabolizzat minn CYP1A2; anqas minn 1% huwa rikoverat fl- awrina bħala anagrelide.
Two major urinary metabolites, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline and N-(5,6-dichloro- 3,4-dihydroquinazalin-2-yl)-2-oxoacetamide have been identified.
Żewġ metaboliti maġġuri fl- awrina, 2- amino- 5, 6- dichloro- 3, 4- dihydroquinazoline u N - (5, 6- dichloro- 3, 4- dihydroquinazalin- 2- yl) - 2- oxoacetamide ġew identifikati.
The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
L- irkupru medju ta ’ 2- amino- 5, 6- dichloro- 3, 4- dihydroquinazoline fl- awrina huwa ta ’ bejn wieħed u ieħor 18% - 35% tad - doża mogħtija.
Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Dejta farmakokinetika minn individwi f’ saħħithom stabbilixxiet li l- ikel inaqqas is- Cmax ta ’ anagrelide b’ 14% imma jżid l- AUC b ’ 20%.
Food had a more significant effect on the active metabolite and decreased the Cmax by 29%, although it had no effect on the AUC.
L- ikel kellu effett aktar sinifikattiv fuq il- metabolit attiv u naqqas is- Cmax b ’ 29% għalkemm ma kellu l- ebda effett fuq l- AUC.
As expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Kif mistenni mill- half- life tiegħu, m’ hemm l- ebda evidenza ta ’ akkumulazzjoni ta ’ anagrelide fil - plażma.
Additionally these results show no evidence of auto-induction of the anagrelide clearance.
Barra minn hekk dawn ir- riżultati ma juru l- ebda evidenza ta ’ awto- induzzjoni ta 'l - eliminazzjoni ta ’ anagrelide.
7 Special populations
7 Popolazzjonijiet speċjali
Children and adolescents Pharmacokinetic data from fasting children and adolescents (age range 7 - 14 years) with essential thrombocythaemia indicate that dose and body weight normalised exposure, Cmax and AUC, of anagrelide were lower in children/ adolescents compared to adults.
Tfal u adoloxxenti Dejta farmakokinetika minn tfal u adolexxenti sajmin (età ta ’ bejn is - 7 u l- 14- il sena) b’ tromboċitemja essenzjali indikat li esponimenti nnormalizzati tad- doża u tal- piż korporali, is- Cmax u l- AUC ta ’ anagrelide kienu aktar baxxi fit- tfal/ adolexxenti meta mqabbla ma ’ ta ’ l- adulti.
There was also a trend to lower exposure to the active metabolite.
Kien hemm ukoll tendenza li jitbaxxa l- esponiment għal metabolit attiv.
These observations may be a reflection of more efficient metabolic clearance in younger subjects.
Dawn l- osservazzjonijiet jistgħu jkunu riflessjoni ta ’ eliminazzjoni metabolika aktar effiċjenti f’ individwi iżgħar.
Elderly Pharmacokinetic data from fasting elderly patients with ET (age range 65-75 years) compared to fasting adult patients (age range 22-50 years) indicate that the Cmax and AUC of anagrelide were 36% and 61% higher respectively in elderly patients, but that the Cmax and AUC of the active metabolite, 2- amino-5, 6-dichloro-3, 4-dihydroquinazoline, were 42% and 37% lower respectively in the elderly patients.
Anzjani Dejta farmakokinetika minn pazjenti anzjani fl- istat sajjem b’ ET (medda ta ’ età ta ’ 65- 75 sena) meta mqabbla ma ’ pazjenti adulti fl- istat sajjem (medda ta ’ età ta ’ 22- 50 sena) tindika li s- Cmax u l- AUC ta ’ anagrelide kienu 36% u 61% ogħla rispettivament f’ pazjenti anzjani, iżda li s- Cmax u l- AUC tal - metabolit attiv, 2- amino- 5, 6- dichloro- 3, 4- dihydroquinazoline, kienu 42% u 37% iktar baxxi fil - pazjenti anzjani.
These differences were likely to be caused by lower presystemic metabolism of anagrelide to 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in the elderly patients.
Dawn id- differenzi kienu x’ aktarx ikkawżati minn metaboliżmu presistemiku iktar baxx ta ’ anagrelide għal 2- amino- 5, 6- dichloro- 3, 4- dihydroquinazoline fil- pazjenti anzjani.
Repeated dose toxicity.
Tossiċità ta ’ dożi rrepetuti.
Following repeated administration of anagrelide, at doses of 1mg/ kg/ day or higher, subendocardial haemorrhage and focal myocardial necrosis occurred in dogs.
Wara l- għoti ripetut ta ’ anagrelide, f’ dożi ta ’ 1mg/ kg/ jum jew ogħla, kien hemm emorraġija sottoendokardjali u nekrożi mijokardjali fokali fil- klieb.
Reproductive toxicology.
Tossiċità fis- sistema riproduttiva.
Maternally toxic doses of anagrelide (60 mg/ kg/ day and above) in rats and rabbits were associated with increased embryo resorption and foetal mortality.
Dożi ta ’ anagrelide li huma tossiċi fil- maternita ’ (60mg/ kg/ jum jew aktar) fil- firien u fil- fniek kienu assoċjati ma żieda fir- risorbiment ta ’ l- embriju u tal- mortalità tal- fetu.
Mutagenic and carcinogenic potential.
Potenzjal mutaġeniku u karċinoġeniku.
Studies on the genotoxic potential of anagrelide did not identify any mutagenic or clastogenic effects.
Studji fuq il- potenzjal ġenotossiku ta ’ anagrelide ma identifika l- ebda effett mutaġeniku jew klastoġeniku.
In a two-year rat carcinogenicity study, non-neoplastic and neoplastic findings were observed and related or attributed to an exaggerated pharmacological effect.
Fi studju dwar il- karċinoġeneċità fil- firien li dam sentejn, kienu osservati sejbiet non- neoplastiċi u neoplastiċi, li kienu marbuta jew attribwiti ma ’ effett farmakoloġiku esaġerat.
Among them, the incidence of adrenal phaeochromocytomas was increased relative to control in males at all dose levels (≥ 3 mg/ kg/ day) and in females receiving 10 mg/ kg/ day and above.
Fosthom, l- inċidenza ta ’ phaeochromocytomas adrenali żdiedet meta mqabbla mal- kontroll fil- firien maskili fil- livelli kollha tad- doża (≥ 3 mg/ kg/ kuljum) u fil- firien femminili li kienu qed jirċievu 10 mg/ kg/ kuljum u aktar.
The lowest dose in males (3 mg/ kg/ day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
L - inqas doża f’ dawk maskili (3 mg/ kg/ kuljum) tikkorrispondi għal 37 darba ta ’ l- espożizzjoni ta ’ l- AUC fil- bniedem wara doża ta ’ 1 mg darbtejn kuljum.
Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
Adenokarċinomi fl- utru, ta ’ oriġini epiġenetika, jistgħu jkunu marbuta ma ’ induzzjoni ta ’ enżima tal- familja CYP1.
They were observed in females receiving 30 mg/ kg/ day, corresponding to 572 times the human AUC exposure after a 1 mg twice daily dose.
Dawn kienu osservati fil- firien femminili li kienu qed jirċievu 30 mg/ kg/ kuljum, li jikkorrispondu għal 572 darba ta ’ l- espożizzjoni ta ’ l- AUC fil- bniedem wara doża ta ’ 1 mg darbtejn kuljum.
Currently, there is no clinical evidence that these findings are of relevance to human use.
Bħalissa, m’ hemm l- ebda evidenza klinika li dawn is- sejbiet huma rilevanti għall- użu fil- bniedem.
Capsule contents Povidone (E1201) Anhydrous lactose Lactose monohydrate Microcrystalline cellulose (E460) Crospovidone Magnesium stearate
X' fihom il- kapsuli Povidone (E1201) Anhydrous lactose Lactose monohydrate Microcrystalline cellulose (E460) Crospovidone Magnesium stearate
Capsule shell Gelatin Titanium dioxide (E171)
8 Il- qoxra tal- kapsula Gelatin Titanium dioxide (E171)
8 Printing ink Shellac Strong ammonium solution Potassium hydroxide (E525) Black iron oxide (E172)
Linka ta 'l- istampar Shellac Soluzzjoni qawwija ta' ammonium Potassium hydroxide (E525) Black iron oxide (E172)
No special precautions for storage
Din il- mediċina m’ għandhiex bżonn ħażna speċjali
High-density polyethylene (HDPE) bottles containing desiccant with child-resistant closures containing 100 capsules
Fliexken ta 'high- density polyethylene (HDPE) li fihom dessikant b' għatu li ma jinfetaħx mit- tfal li fihom 100 kapsula.
Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom
Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP Ir- Renju Unit
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Wasdell Packaging Limited, Upper Mills Estate, Bristol Road, Stonehouse, Gloucestershire, GL10 2BJ, United Kingdom
Wasdell Packaging Limited, Upper Mills Estate, Bristol Road, Stonehouse, Gloucestershire, GL10 2BJ, Ir- Renju Unit
Summary of Product Characteristics, 4.2).
Karatteristiċi tal- Prodott fil - Qosor, 4. 2).
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Sid ta 'din l- awtorizzazzjoni għall- kummerċ għandu jagħti tagħrif lill- Kummissjoni Ewropeja dwar il - pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b' din id- deċiżjoni.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena.
Shire will conduct a Post Authorisation Safety Study (PASS) Study SPD422-401 A non- interventional, post authorisation safety study, to continuously monitor safety and pregnancy outcomes in a cohort of at-risk Essential Thrombocythaemia (ET) subjects exposed to Xagrid compared to other conventional cytoreductive treatments.
Shire ser tmexxi Studju dwar is- Sigurtà ta 'Wara l- Awtorizzazzjoni (PASS) SPD422- 401 Studju dwar is- sigurtà ta' wara l- awtorizzazzjoni li ma jintervjenix, sabiex jiġu kontinwament mmonitorjati riżultati dwar is- sigurtà u t- tqala f' ko- orti ta 'individwi li jbatu bi Tromboċitemja Essenzjali (ET) li jinsabu f’ riskju u huma esposti għal Xangrid mqabbel ma' trattamenti konvenzjonali ċitoriduttivi oħra.
Objectives:
Għanijiet:
Primary To continuously monitor safety and pregnancy outcomes in a cohort of at-risk ET subjects exposed to Xagrid compared to other conventional cytoreductive treatments.
Ewlieni Sabiex kontinwament jiġu monitorati riżultati dwar sigurtà u tqala f' ko- orti ta 'individwi b’ ET li jinsabuf’ riskju u li huma esposti għal Xagrid meta mqabbel ma trattamenti ċitoriduttivi konvenzjonali oħrajn.
Secondary Efficacy (platelet reduction, incidence of thrombohaemorrhagic events).
Sekondarji Effikaċja (tnaqqis fil- plejtlets, inċidenza ta każijiet tromboemorragiċi).
Drug utilisation (drug type, drug dose, duration of exposure).
Użu ta 'mediċini (tip ta' mediċini, doża tal- mediċina, tul ta 'espożizzjoni).
Updates and progress reports will be provided at 6 monthly intervals for 5 years post-approval on patients treated with Xagrid.
Rapporti ta ’ aġġornamenti u progress dwar pazjenti trattati b' Xagrid ser jiġu provduti f' intervalli ta '6 xhur għal 5 snin wara l- approvazzjoni.
Following the 5 year review the study may be continued for an additional 5 years to obtain specific information on:
Wara r- reviżjoni ta '5 snin l- istudju jista' jissokta għal 5 snin oħra sabiex tinkiseb informazzjoni speċifika dwar:
Pregnancy outcomes and follow-up in women of childbearing potential, Haematological transformations.
Riżultati fit- tqala u l- follow- up f' nisa li jista 'jkollhom it- tfal, trasformazzjonijiet ematoloġiċi.
Study recruitment was initiated during May 2005.
Ir- rekrutaġġ għall- istudju beda matul Mejju 2005.
The sixth and seventh 6-monthly safety update reports are expected in May 2008 and November 2008, respectively.
Is- sitt u s- seba ’ rapporti ta 'aġġornamenti dwar is- sigurta ta' kull 6 xhur huma mistennija f' Mejju 2008 u Novembru 2008, rispettivament.
Shire will conduct a randomised, comparative study in patients with ET.
Shire ser tmexxi studju komparattiv li fih il- pazjenti b ’ 'ET ntgħażlu bl- addoċc.
Study SPD422-403.
Studju SPD422- 403.
A Phase IIIb, randomised study to compare the efficacy, tolerability and safety of anagrelide hydrochloride versus hydroxyurea in high-risk patients with essential thrombocythaemia.
Studju ta 'Fażi IIIb, li fih il- pazjenti ntgħażlu bl- addoċc sabiex iqabbel l- effikaċja, it - tollerabilità u s- sigurtà ta' anagrelide
Objectives:
hydrochloride kontra hydroxyurea f' pazjenti bi
11 Primary:
Ewlieni:
To compare the safety of anagrelide and hydroxyurea in short and long term usage of up to three years with particular reference to cardiovascular safety (as assessed by echocardiography).
Sabiex tiġi mqabbla s- sigurtà ta 'anagrelide u hydroxyurea meta jintużaw fuq perijodu qasir u fit - tul sa tliet snin b' referenza partikolari għas- sigurà kardjovaskulari (kif assessjat b' ekokardjografija).
Secondary:
Sekondarji:
To compare the efficacy of anagrelide and hydroxyurea in terms of the platelet count after 6 months of treatment.
Sabiex tiġi mqabbla l- effikaċja ta 'anagrelide u hydroxurea f' termini ta' l- għadd ta 'plejtlets wara 6 xhur ta' trattament.
To compare the efficacy of anagrelide and hydroxyurea in terms of the platelet count after 3 months of treatment.
Sabiex tiġi mqabbla l- effikaċja ta 'anagrelide u hydroxurea f' termini ta' l- għadd ta 'plejtlets wara 3 xhur ta' trattament.
To compare the efficacy of anagrelide and hydroxyurea in terms of the number of patients achieving a complete response.
Sabiex tiġi mqabbla l- effikaċja ta 'anagrelide u hydroxurea f' termini ta' l- għadd ta 'pazjenti li jkollhom respons komplet.
To compare the cytoreductive impact of anagrelide and hydroxyurea on white blood cell and red blood cell lines.
Sabiex jiġi mqabbel l- impatt ċitoriduttiv ta 'anagrelide u hydroxyurea fuq ir- razez ta' ċelloli bojod u ċelloli ħomor.
To investigate the tolerability of anagrelide and hydroxyurea in short and long term usage of up to three years.
Sabiex tiġi mistħarrġa t- tollerabilità ta 'anagrelide u hydroyxurea meta jintużaw għal perijodu ta' żmien qasir u fit- tul sa tliet snin.
To investigate the effects of anagrelide and hydroxyurea on incidence of disease related thrombotic and haemorrhagic events.
Sabiex jiġu mistħarrġa l- effetti ta 'anagrelide u hydroxyurea fuq inċidenzi ta' każijiet trombotiċi u emorraġiċi relatati mal- mard.
To compare the average time to response following treatment with anagrelide or hydroxyurea.
Sabiex jiġu mqabbla l- ħinijiet medji ta 'respons wara trattament b' anagrelide jew hydroxyurea.
The study will include a centralized and blinded review of the echocardiographs as part of the assessment of the effect of both treatments on LVEF.
L- istudju għandu jinkludi eżaminazzjoni centralized u blinded ta 'l- ekokardjografiji bħala parti mill- eżami ta' l- effetti taż- żewġ trattamenti fuq LVEF.
Interim safety reports every 6 months.
Rapporti interim dwar is- sigurtà kull 6 xhur.
Progress and recruitment updates will be provided alongside the standard PSURs.
Aġġornamenti dwar il- progress u r- rekrutaġġ għandhom jiġu provduti flimkien mal- PSURs standard.
The final study report will be provided 4 months after data base lock.
Ir- rapport ta 'studju finali għandu jiġi provdut 4 xhur wara l- għeluq fid- database.
Study recruitment was initiated during January 2006.
Ir- rekrutaġġ għall- istudju beda matul Jannar 2006.
The sixth and seventh 6-monthly safety update reports are expected in May 2008 and November 2008, respectively.
Is- sitt u s- seba ’ rapporti ta 'aġġornamenti ta' kull 6 xhur huma mistennija f' Mejju 2008 u Novembru 2008, rispettivament.
Shire will conduct a pharmacokinetic study in young and elderly patients with ET.
Shire ser tmexxi studju farmakokinetiku f' pazjenti b' ET żgħar u anzjani.
Study SPD422-203 A phase II, open label, multi centre, pharmacokinetic, pharmacodynamic and safety study of anagrelide hydrochloride in young (18-50 years) and elderly (≥ 65 years) patients with essential thrombocythaemia.
Studju SPD422- 203 Studju ta 'fażi II, open label, multi ċentrali, farmakokinetiku, farmakodinamiku u ta ’ sigurta’ dwar anagrelide hydrochloride f' pazjenti żgħar (18- 50 sena) u anzjani (≥ 65 sena) bi tromboċitopenja essenzjali Għanijiet:
Primary:
Ewlieni:
To compare the steady state pharmacokinetic profile of anagrelide and its active metabolite in young (18-50 years) versus elderly (≥ 65 years) essential thrombocythaemia (ET) patients.
Sabiex jiġi mqabbel il- profil farmakokinetiku fi stat fiss ta 'anagrelide u l- metabolit attiv tiegħu f' pazjenti b' tromboċitopenija essenzjali (ET) żgħar (18- 50 sena) u anzjani (65 sena).
To evaluate the correlation, if any, between plasma concentration of anagrelide and its active metabolite and heart rate and blood pressure in young (18-50 years) and elderly (≥ 65 years) ET patients.
Sabiex tiġi evalwata l- korrelazzjoni, jekk hemm, bejn doża ta 'kuljum ta' anagrelide u l - konċentrazzjonijiet tal- plażma ta 'anagrelide u bidliet mil- livell bażi ta' riferiment fl- għadd ta 'plejtlets f' pazjenti żgħar (18- 50 sena) u anzjani (≥ 65 sena) b' ET Sabiex tiġi evalwata l- korrelazzjoni, jekk hemm, bejn konċentrazzjoni ta' anagrelide fil- plażma u l- metabolit attiv tiegħu u r- rata tal- qalb u l- pressjoni tad- demm f' pazjenti b' ET ta 'eta żgħira (18 - 50 sena) u anzjani (≥ 65 sena).
To assess the safety and tolerability of anagrelide in young (18-50 years) and elderly (≥ 65 years) ET patients.
Sabiex tiġi assessjata s- sigurtà u t- tollerabilità f' pazjenti b' ET żgħar (18- 50 sena) u anzjani (≥ 65 sena).
24 patients (12 per age group) will be enrolled into the study.
24 pazjent (12 f’ kull grupp ta 'etajiet) ser jiġu rekrutati fl- istudju.
Shire will provide pharmacokinetic data from a cohort of elderly patients.
Shire ser tipprovdi dejta farmakokinetika minn ko- orti ta 'pazjenti anzjani.
Progress and recruitment updates will be provided alongside the standard PSURs.
12 progress u r- rekrutaġġ għandhom jiġu pprovduti flimkien mal- PSURs standard.
Study recruitment was initiated during September 2006.
Ir- rekrutaġġ għall- istudju beda matul Settembru 2006.
Shire will provide an annual update of all published data concerning the efficacy and safety of anagrelide in ET patients alongside the annual PSURs (years 1 to 4 post-approval) and as part
Shire ser tipprovdi aġġornament kull sena tad- dejta kollha ppubblikata dwar l- effiċjenza u s - sigurtà ta 'anagrelide f' pazjenti b' ET flimkien mal- PSURs annwali (snin 1- 4 ta' wara l - approvazzjoni) u bħala parti mit- tiġdid ta 'l- applikazzjoni.
The fourth annual update is expected as part of the fourth Annual Reassessment Report in November 2008.
Ir- raba ’ aġġornament annwali hu mistenni bħala parti mir- raba ’ Rapport Annwali tar- rivalutazzjoni f' Novembru 2008.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA JEW, FIN- NUQQAS TA' DAN FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
(OUTER CARTON AND LABEL)
(KARTUNA TA 'BARRA U TIKKETTA)
Xagrid 0.5mg hard capsules Anagrelide (as hydrochloride)
Xagrid 0. 5mg kapsuli iebsin Anagrelide (bħala hydrochloride)
One capsule contains 0.5mg anagrelide (as hydrochloride)
Kapsula waħda fiha 0. 5mg anagrelide (bħala hydrochloride)
Xagrid capsules also contain lactose.
Il- kapsuli Xagrid fihom ukoll lactose
100 hard capsules
100 kapsula iebsa
Oral use Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu
There are no special storage instructions
Din il- mediċina m’ għandhiex bżonn ħażna speċjali
Shire Pharmaceutical Contracts Ltd Basingstoke, RG24 8EP, UK
Shire Pharmaceutical Contracts Ltd Basingstoke, RG24 8EP, UK
18 PACKAGE LEAFLET:
18 FULJETT TA 'TAGĦRIF:
Xagrid 0.5mg hard capsules (anagrelide)
Xagrid 0. 5mg kapsuli iebsin (anagrelide)
Read all of this leaflet carefully before you start taking this medicine • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you.
Jista 'jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija għall- użu personali tiegħek.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Xagrid is and what it is used for 2.
X’ inhu Xagrid u għalxiex jintuża 2.
Before you take Xagrid 3.
Qabel ma tieħu Xagrid 3.
How to take Xagrid 4.
Kif għandek tieħu Xagrid 4.
How to store Xagrid 6.
Kif taħżen Xagrid 6.
WHAT XAGRID IS AND WHAT IT IS USED FOR
X’ INHU XAGRID U GĦALXIEX JINTUŻA
Xagrid is a medicine which interferes with the development of platelets.
Xagrid huwa mediċina li jinterferixxi ma 'l- iżvilupp tal- plejtlets.
It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level.
Huwa jnaqqas l- għadd ta 'plejtlets magħmula fil- mudullun, li jirriżulta f' għadd imnaqqas ta' plejtlets fid- demm biex jintlaħaq livell aktar normali.
For this reason it is used to treat patients with essential thrombocythaemia.
Għal din ir- raġuni huwa jintuża biex jittratta pazjenti bi tromboċitopenja essenzjali.
Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets.
Tromboċitopenja essenzjai hija kondizzjoni li sseħħ meta l- mudullun jipproduċi wisq ċelluli tad- demm magħrufa bħala plejtlets.
Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.
Għadd kbir ta 'plejtlets fid- demm jistgħu joħolqu problemi serji fic - ċirkolazzjoni u fit- tagħqid tad- demm.
BEFORE YOU TAKE XAGRID
QABEL MA TIEĦU XAGRID
Do not take Xagrid: • If you have had an allergic reaction to anagrelide or to any of the other ingredients in Xagrid.
Tiħux Xagrid • Jekk kellek xi reazzjoni allerġika għal anagrelide jew għal xi sustanza oħra ta 'Xagrid.
Check the ingredients of Xagrid listed in Section 6 of this leaflet.
Iċċekkja l - ingredjenti ta 'Xagrid elenkati f’ Sezzjoni 6 ta ’ dan il- fuljett.
An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath. • If you have moderate or severe liver problems • If you have moderate or severe kidney problems
Reazzjoni allerġika tista 'tiġi rikonoxxuta b' raxx, ħakk, wiċċ jew xofftejn minfuħa jew qtugħ ta ’ nifs. • Jekk għandek problemi moderati jew serji tal- fwied • Jekk għandek problemi moderati jew serji tal- kliewi
Take special care with Xagrid:
Oqgħod attent ħafna b' Xagrid:
Before treatment with Xagrid, tell your doctor • If you have or think you might have a problem with your heart • If you have any problems with your liver or kidneys • If you are pregnant or breastfeeding • If you have been told by a doctor that you have an intolerance to some sugars.
Qabel il- kura b’ Xagrid, għid it- tabib tiegħek • Jekk għandek jew taħseb li jista 'jkollok problema b' qalbek • Jekk għandek xi problemi bil- fwied jew il- kliewi tiegħek • Jekk inti tqila jew qed tredda' • Jekk it- tabib qallek li għandek intolleranza għal xi tipi ta ’ zokkor.
Tell your doctor if you are taking any of the following medicines: - • Fluvoxamine used to treat depression
Għid lit- tabib tiegħek jekk qed tieħu xi waħda minn dawn il- mediċini li ġejjin: - • Fluvoxamine li jintuża biex jikkura d- dipressjoni
19 • Omeprazole used to treat gastro-intestinal problems like reflux oesophagitis and duodenal and gastric ulcers • Theophylline used to treat severe asthma and breathing problems • Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone, olprinone and cilostazol • Acetylsalicylic acid (aspirin) used to treat mild to moderate pain, for example, headaches • Other medicines used to treat conditions affecting the platelets in your blood.
19 • Omeprazole li jintuża biex jikkura problemi gastrointestinali bħar- rifluss ta ’ l- esofaġite u ulċeri duwodenali u gastriċi • Theophylline li jintuża biex jikkura problemi severi ta ’ l- ażżma u tan- nifs • Mediċini li jintużaw biex jikkuraw disturbi tal- qalb, per eżempju, milrinone, enoximone, amrinone, olprinone and cilostazol • Acetylsalicylic acid (aspirina) li tintuża biex tikkura uġigħ minn ħafif sa moderat, per eżempju, uġigħ ta ’ ras • Mediċini oħrajn li jintużaw biex jikkuraw kundizzjonijiet li jaffettwaw il- plejtlits fid- demm tiegħek.
Xagrid or these medicines may not work properly if taken together.
Xagrid jew dawn il- mediċini jistgħu ma jaħdmux kif suppost jekk jittieħdu flimkien.
If you are not sure, speak to your doctor or pharmacist for advice.
Jekk m’ intix ċert/ a, kellem lit- tabib jew lill- ispiżjar tiegħek għall- parir.
Taking Xagrid with food and drink:
Meta tieħu Xagrid ma ’ l- ikel u max- xorb:
Your capsules may be taken with food or after a meal or on an empty stomach.
Il- kapsuli jistgħu jittieħdu ma ’ l- ikel jew wara l- ikel jew fuq stonku vojt.
For more information on how to take your medicine, please refer to section 3.
Għal iktar informazzjoni fuq kif tieħu l- mediċina tiegħek, jekk jogħġbok irreferi għal sezzjoni 3.
There is limited data for the use of Xagrid in children and therefore Xagrid should be used with caution.
Tfal u adoloxxenti Hemm informazzjoni limitata dwar l- użu ta ’ Xagrid fit- tfal u għalhekk Xagrid għandu jintuża bl - attenzjoni.
Tell your doctor if you are pregnant or are planning to become pregnant.
Għid lit- tabib tiegħek jekk inti tqila jew qed tippjana biex tinqabad tqila.
Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking Xagrid.
Xagrid m’ għandux jingħata lil nisa tqal. Nisa li huma f' riskju li jinqabdu tqal għandhom ikunu ċerti li qed jużaw kontraċezzjoni effettiva meta jieħdu Xagrid.
Speak to your doctor if you need advice with contraception.
Kellem lit- tabib tiegħek jekk teħtieġ parir dwar kontraċezzjoni.
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Għid lit- tabib tiegħek jekk qed tredda 'jew qed tippjana li tredda' lit- tarbija tiegħek.
Xagrid should not be taken while breast-feeding.
Xagrid m' għandux jittieħed meta tkun qed tredda '.
You must stop breast-feeding if you are taking Xagrid.
Għandek tieqaf tredda 'jekk qed tieħu Xagrid.
Dizziness has been reported by some patients taking Xagrid.
Sewqan u tħaddim ta 'magni Xi pazjenti rraportaw li kellhom sturdamenti meta kienu fuq Xagrid.
Do not drive or use machinery if you are affected.
La għandek issuq u lanqas tħaddem magni jekk tiġi affettwat.
Important information about some of the ingredients of Xagrid Lactose is an ingredient in Xagrid.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Xagrid Lactose hu sustanza f’ Xagrid.
If you have been told that you have an intolerance to some sugars, contact your doctor before taking the capsules.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu l- kapsuli.
HOW TO TAKE XAGRID
KIF GĦANDEK TIEĦU XAGRID
Always take Xagrid exactly as your doctor has told you.
Dejjem għandek tieħu Xagrid skond il- parir tat- tabib.
The amount of Xagrid that people take can be different, and this depends on your condition.
L- ammont ta 'Xagrid li persuni jistgħu jieħdu jista' jkun differenti, u dan jiddependi mill- kundizzjoni tiegħek.
Your doctor will prescribe the best dose for you.
It- tabib tiegħek ser jiktiblek l- aħjar doża adattata għalik.
The usual starting dose of Xagrid is 1mg (2 of these capsules) per day, taken as one capsule twice a day, for at least one week.
Id- doża ta ’ Xagrid li wieħed ġeneralment jibda biha hija ta '1mg (2 minn dawn il- kapsuli) kuljum, li tittieħed bħala kapsula waħda darbtejn kuljum, għal ta' l- anqas ġimgħa.
After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.
Wara dan iż- żmien it- tabib tiegħek jista 'jżid jew inaqqas in- numru ta' kapsuli li għandek tieħu sabiex tinstab l- aktar doża adattata għalik u li tittratta il- kundizzjoni tiegħek bl- aktar mod effettiv.
Your capsules should be swallowed whole with a glass of water.
Il- kapsuli għandhom jinbelgħu sħaħ b' tazza ilma.
They may be taken with food or after a meal or on an empty stomach.
Jistgħu jittieħdu ma 'l- ikel jew wara xi ikla jew fuq stonku vojt.
It is best to take the capsules at the same time every day.
L- aħjar hu li dawn il- kapsuli jittieħdu fl- istess ħin kuljum.
Do not take more capsules than your doctor has recommended.
M' għandekx tieħu aktar kapsuli mill- ammont rakkomandat mit- tabib tiegħek.
20 Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively.
20 It- tabib tiegħek ser jgħidlek biex tagħmel testijiet tad- demm b' mod regolari sabiex jiċċekkja li l - mediċina qed taħdem b' mod effettiv.
If you take more Xagrid than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Jekk tieħu Xagrid aktar milli suppost Jekk tieħu Xagrid aktar milli suppost jew jekk xi ħadd ieħor ħa l- mediċina tiegħek, kellem lit- tabib jew lill- ispiżjar tiegħek minnufih.
Show them the pack of Xagrid.
Urihom il- pakkett ta 'Xagrid.
Take your capsules as soon as you remember.
Jekk tinsa tieħu Xagrid Ħu l- kapsuli tiegħek malli tiftakar.
Take your next dose at the usual time.
Ħu d- doża tiegħek li jmiss fil- ħin li suppost.
Like all medicines, Xagrid can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xagrid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
If you are worried, speak to your doctor.
Jekk qed tinkwieta, kellem lit- tabib tiegħek.
Very common side effects (may occur in more than 1 in 10 patients):
Effetti sekondarji komuni ħafna (jistgħu jseħħu f’ iktar minn 1 minn kull 10 pazjenti):
Common side effects (may occur in fewer than 1 in 10, but more than 1 in 100 patients):
Effetti sekondarji komuni (jistgħu jseħħu f’ inqas minn 1 minn kull 10 pazjenti, iżda f’ iktar minn 1 minn kull 100 pazjent):