FrancophonIA/ELRC3.0 huggingface dataset:
English: Tachycardia Palpitations
Maltese: Takikardija Palpitazzjo nijiet
English: An opaque white hard capsule imprinted with S 063.
Maltese: Kapsula iebsa bajda matta li fuqha hemm stampat S 063.
English: The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four openlabel, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative neoplasms (MPNs).
Maltese: 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'neoplażmi majeloproliferattivi (MPNs).
English: Serious cardiovascular adverse events including cases of torsade de pointes, ventricular tachycardia, cardiomyopathy, cardiomegaly and congestive heart failure have been reported (see section 4.8).
Maltese: Avvenimenti avversi kardjovaskulari serji li jinkludu każijiet ta' torsade de pointes, takikardija ventrikulari, kardjomijopatija, kardjomegalija u insuffiċjenza konġestiva tal-qalb ġew irrappurtati (ara sezzjoni 4.8).
English: Xagrid 0.5 mg hard capsules.
Maltese: Xagrid kapsula iebsa ta' 0.5 mg.
English: The most commonly reported adverse reactions associated with anagrelide 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%.
Maltese: L-aktar reazzjoni avversa komuni rrapportata assoċjata ma' anagrelide kienet l-uġigħ ta' ras li seħħet f'madwar 14%, palpitazzjonijiet li seħħew, f'madwar 9%, akkumulazzjoni ta' fluwidu u nawsja li ttnejn seħħew f'madwar 6%, u dijarea li seħħet f'5%.
English: The capsules are provided in bottles containing 100 hard capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 kapsula iebsa
English: EU/1/04/295/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/295/001
English: Pharmacokinetic data from exposed fasting children and adolescents (age range 7 - 16 years) with essential thrombocythaemia indicate that dose normalised exposure, Cmax and AUC, of anagrelide tended to be higher in children/adolescents compared with adults.
Maltese: Dejta farmakokinetika minn tfal u adolexxenti sajmin b'mod espost (età ta' bejn is 7 u 16-il sena) b'tromboċitemja essenzjali indikat li esponimenti nnormalizzati tad-doża, is-Cmax u l-AUC ta' anagrelide kellhom tendenza li jkunu ogħla fit-tfal/adolexxenti meta mqabbla ma' ta' l-adulti.
English: Very limited data are available on the use of anagrelide in the paediatric population and anagrelide should be used in this patient group with caution (see sections 4.2, 4.8, 5.1 and 5.2).
Maltese: Hemm dejta limitata ħafna dwar l-użu ta' anagrelide fil-popolazzjoni pedjatrika u anagrelide għandu jintuża b'kawtela f'dan il-grupp ta' pazjenti (ara sezzjonijiet 4.2, 4.8, 5.1 u 5.2).
English: 48 patients aged 6-17 years (19 children and 29 adolescents) have received anagrelide for up to 6.5 years either in clinical studies or as part of a disease registry (see section 5.1).
Maltese: 48 pazjent li kellhom 6-17-il sena (19 tfal u 29 adolexxenti) irċivew anagrelide għal sa 6.5 snin jew fi studji kliniċi jew bħala parti minn reġistru ta' mard (ara sezzjoni 5.1).
English: • 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.
Maltese: • 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.
English: Reported symptoms include sinus tachycardia and vomiting.
Maltese: Sintomi rrapportati jinkludu sinus, takikardja u rimettar.
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
Maltese: Anagrelide huwa impeditur ta' cyclic AMP phosphodiesterase
English: High-density polyethylene (HDPE) bottles with child-resistant closures and desiccant containing 100 capsules.
Maltese: Fliexken ta' high-density polyethylene (HDPE) b'għatu li ma jinfetaħx mit-tfal u dessikant li fihom 100 kapsula.
English: Atrial fibrillation Supraventricular tachycardia Arrhythmia Hypertension Syncope
Maltese: Sensittività eċċessiva għal anagrelide jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni
English: In studies 700-012, 700-014, 700-999 and study 13970-301 the time to complete response ranged from 4 to 12 weeks.
Maltese: 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.
English: In earlier, open-label studies, median platelet count reductions were observed in 7 children and 9 adolescents treated for between 3 months and 6.5 years.
Maltese: Fi studji open-label iktar bikrin, it-tnaqqis fil-medjan tal-għadd tal-plejtlits ġie osservat f'7 itfal u 9 adolexxenti kkurati għal bejn 3 xhur u 6.5 snin.
English: A feeling of weakness or feeling unwell, high blood pressure, irregular heart beat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle aches, painful joints, back pain, decreased or loss of feeling or sensation such as numbness, especially in the skin, abnormal feeling or sensation such as tingling and ‘pins and needles', sleeplessness, depression, confusion, nervousness, dry mouth, loss of memory, breathlessness, nosebleed, serious lung infection with fever, shortness of breath, cough, phlegm; hair loss, skin itching or discolouration, impotence, chest pain, reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia), accumulation of fluid around the lungs or an increase in liver enzymes.
Maltese: Effetti sekondarji mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 persuna Tħossok debboli jew ma tħossokx f'tiegħek, pressjoni għolja tad-demm, taħbit tal-qalb irregolari, ħass ħażin, sried jew deni, indiġestjoni, telf ta' aptit, stitikezza, tbenġil, ħruġ ta' demm, nefħa (edema), telf ta' piż, uġigħ fil-muskoli, ġogi muġugħa, uġigħ fid-dahar, tnaqqis jew telf ta' ħass jew sensazzjoni bħal tnemnim, speċjalment fil-ġilda, sensazzjoni anormali jew sensazzjoni bħal tnemmin u sensazzjoni bħal qisu xi ħadd qed iniggżek bil-labar, ngħas, dipressjoni, konfużjoni, nervi, ħalq xott, telf ta' memorja, nuqqas ta' nifs, l-imnieħer jinfaraġ, infezzjoni serja fil-pulmun bid-deni, qtugħ ta' nifs, sogħla, imħat li jinqata' mas-sogħla; telf ta' xagħar, ħakk fil-ġilda jew tibdil fil-kulur, impotenza, uġigħ fis-sider, tnaqqis fil-plejtlits tad-demm, li jżid ir-riskju ta' ħruġ ta' demm jew tbenġil (tromboċitopenija), akkumulazzjoni ta' fluwidu madwar il-pulmun jew żieda fl-enżimi tal-fwied.
English: Interstitial lung disease including pneumonitis and allergic alveolitis
Maltese: Mard interstizjali tal-pulmun li jinkludi pnewmonite u alveolite allerġika
English: Anagrelide at ≥60 mg/kg increased parturition time and mortality in the dam and foetus respectively.
Maltese: Anagrelide f'doża ta' ≥60 mg/kg żied it-tul tal-ħin tal-ħlas u l-mortalità fl-ommijiet firien u l-feti rispettivament.
English: Therapy requires close clinical supervision of the patient which will include a full blood count (haemoglobin and white blood cell and platelet counts), assessment of liver function (ALT and AST), renal function (serum creatinine and urea) and electrolytes (potassium, magnesium and calcium).
Maltese: It-terapija li għandha tinkludi l-għadd tad-demm komplut (emoġlobina u ċelloli bojod tad-demm u għadd tal-plejtlets), stima ta' tal-funzjoni tal-fwied (ALT u AST), tal-funzjoni renali (kreatinina fisserum u urea) u elettroliti (potassium, magnesium u calcium) teħtieġ sorveljanza klinika mill-qrib talpazjent.
English: At the NOEL dose (30mg/kg/day), the AUCs for anagrelide and the metabolites BCH24426 and RL603 were 425-, 31- and 13-fold higher than the AUC in humans administered an oral dose of anagrelide 2 mg/day, respectively.
Maltese: Fid-doża NOEL (30 mg/kg/jum), l-AUCs għal anagrelide u l-metaboliti BCH24426 u RL603 kienu 425, 31 u 13-il darba ogħla mill-AUC fi bnedmin li ngħataw doża orali ta' anagrelide ta' 2 mg/jum, rispettivament.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Headache Dizziness Depression Amnesia
Maltese: Sturdament Dipressjoni Amnesija
English: Concomitant use of anagrelide with other PDE III inhibitors such as milrinone, amrinone, enoximone, olprinone and cilostazol is not recommended.
Maltese: L-użu ta' anagrelide flimkien ma' impedituri oħrajn PDE III bħal ma huma milrinone, amrinone, enoximone, olprinone u cilostazol mhux rakkomandat.
English: Pulmonary hypertension
Maltese: Indeboliment epatiku
English: One hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride).
Maltese: Kull kapsula iebsa fiha 0.5 mg anagrelide (bħala anagrelide hydrochloride).
English: Also contains lactose.
Maltese: TA' EĊĊIPJENTI Fih ukoll lactose.
English: How to take Xagrid
Maltese: Ġilda xotta
English: In an open-label clinical study in 8 children and 10 adolescents (including patients who were anagrelide treatment naïve or who had been receiving anagrelide for up to 5 years pre-study), median platelet counts were decreased to controlled levels after 12 weeks of treatment.
Maltese: Fi studju kliniku open-label fi 8 itfal u 10 adolexxenti (li jinkludu pazjenti li qatt ma rċivew kura b'anagrelide fil-passat jew li kienu ġew qed jirċievu anagrelide għal sa 5 snin qabel l-istudju), l-għadd medjan tal-plejtlits naqas għal livelli kkontrollati wara 12-il ġimgħa ta' kura.
English: 9/l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
Maltese: 9/l jew tnaqqis ta' ≥ 50% mil-linja bażi ta' riferimet u tat-tnaqqis jibqa' għal ta' l-anqas 4 ġimgħat.
English: Package leaflet: Information for the patient Xagrid 0.5 mg hard capsules anagrelide
Maltese: Informazzjoni għall-pazjent Xagrid 0.5 mg kapsuli ibsin anagrelide
English: • Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone, olprinone and cilostazol;
Maltese: amrinone, olprinone and cilostazol;
English: Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease, (signs include fatigue, chest pain and palpitations), enlarged heart, accumulation of fluid around the heart, loss of coordination, difficulty in speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness on standing up (especially when getting up from a sitting or lying position), increased need to pass water at night, pain, ‘flu-like' symptoms, sleepiness, widening of blood vessels, inflammation of the large bowel (signs include: diarrhoea, usually with blood and mucus, stomach pain, fever), inflammation of the stomach (signs include: pain, nausea, vomiting), area of abnormal density in the lung, increased creatinine level in blood tests, which may be a sign of kidney problems.
Maltese: Effetti sekondarji rari: jistgħu jaffettwaw sa 1 minn kull 1,000 persuna Fsada fil-ħanek, żieda fil-piż, uġigħ sever fis-sider (anġina pectoris), mard fil-muskolu tal-qalb (sinjali jinkludu għeja, uġigħ fis-sider u palpitazzjonijiet), qalb imkabbra, akkumulazzjoni ta' fluwidu madwar il-qalb, telf fil-koordinazzjoni, diffikultà meta wieħed jitkellem, ġilda xotta, emigranja, disturbi filvista jew vista doppja, ċenċil fil-widnejn, sturdament meta tqum bilwieqfa (speċjalment meta tqum minn pożizzjoni bilqiegħda jew mimduda), bżonn aktar ta' spiss biex tagħmel l-awrina bil-lejl, uġigħ, sintomi bħal tar-riħ / l-influwenza, ngħas, twessigħ tal-vini/arterji tad-demm, infjammazzjoni talmusrana l-kbira (sinjali jinkludu: dijarea, normalment bid-demm u mukus, uġigħ fl-istonku, deni), infjammazzjoni tal-istonku (sinjali jinkludu: uġigħ, dardir, rimettar), żona ta' densità mhux normali fil-pulmun, żieda fil-livell tal-krejatinina fit-testijiet tad-demm, li tista' tkun sinjal ta' problemi filkliewi.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC Code: L01XX35.
Maltese: Sustanzi antineoplastiċi oħrajn, Kodiċi ATC:
English: • If you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes e.g. potassium, magnesium or calcium (see section “Other medicines and Xagrid”);
Maltese: • Jekk inti twelidt bi, jew għandek storja medika familjari ta' intervall tal-QT imtawwal (li jidher fuq ECG, reġistrazzjoni elettrika tal-qalb), jew qed tieħu mediċini oħrajn li jirriżultaw f'tibdil mhux normali tal-ECG, jew jekk għandek livelli baxxi ta' elettroliti, eż. potassium, magnesium jew calcium (ara sezzjoni “Mediċini oħra u Xagrid”);
English: The NOEL (10mg/kg/day) to this effect was 143, 12 and 11-fold higher than the AUC in humans administered a dose of anagrelide 2 mg/day, and the metabolites BCH24426 and RL603, respectively.
Maltese: L-NOEL (10 mg/kg/jum) għal dan l-effett kien ta' 143, 12 u 11-il darba ogħla mill-AUC fil-bnedmin li ngħataw doża ta' anagrelide ta' 2 mg/jum, u lmetaboliti BCH24426 u RL603, rispettivament.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucosegalactose m'għandhomx jieħdu din ilmediċina.
English: • > 60 years of age or
Maltese: • >`il fuq minn 60 sena jew
English: The maximum change in mean heart rate occurred at 2 hours after administration and was +7.8 beats per minute (bpm) for 0.5 mg and +29.1 bpm for 2.5 mg.
Maltese: Il-bidla massima fir-rata medja ta' taħbit tal-qalb seħħet sagħtejn wara l-għoti u kienet ta' +7.8 taħbitiet kull minuta (bpm) għal 0.5 mg u +29.1 bpm għall 2.5 mg.
English: Xagrid is supplied as opaque, white, hard capsules.
Maltese: Xagrid hu pprovdut bħala kapsuli opaki, bojod u ibsin.
English: Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1mg/kg/day or higher in males and females with males being more sensitive.
Maltese: Wara l-għoti orali ripetut ta' anagrelide fil-klieb, emorraġija sottoendokardjali u nekrożi mijokardjali ġiet osservata f'doża ta' 1 mg/kg/jum jew ogħla fl-irġiel u n-nisa, bl-irġiel li kienu aktar sensittivi.
English: The no observed effect level (NOEL) for male dogs (0.3mg/kg/day) corresponds to 0.1, 0.1, and 1.6-fold the AUC in humans for anagrelide at 2mg/day, and the metabolites BCH24426 and RL603, respectively.
Maltese: Illivell ta' ebda effett osservat (NOEL - no observed effect level) għal klieb irġiel (0.3 mg/kg/jum) jikkorrispondi għal 0.1, 0.1, u 1.6 drabi tal-AUC fil-bnedmin għal anagrelide f'doża ta' 2 mg/jum, u lmetaboliti BCH24426 u RL603, rispettivament.
English: In male rats, anagrelide at oral doses up to 240 mg/kg/day (>1000 times a 2mg/day dose, based on body surface area) was found to have no effect on fertility and reproductive performance.
Maltese: F'firien irġiel, anagrelide f'dożi orali sa 240 mg/kg/jum (>1000 darba aktar minn doża ta' 2 mg/jum, ibbażat fuq is-superfiċje tal-ġisem) instab li ma kellu l-ebda effett fuq il-fertilità u l-prestazzjoni riproduttiva.
English: Gastrointestinal haemorrhage Pancreatitis Anorexia Dyspepsia Constipation
Maltese: Emorraġija gastrointestinali Pankreatite Anoreksja Dispepsja Stitikezza Disturb gastrointestinali
English: At the NOEL dose (3mg/kg/day), the AUCs for anagrelide and the metabolites BCH24426 and RL603 were 14, 2 and 2-fold higher than the AUC in humans administered an oral dose of anagrelide 2mg/day.
Maltese: Fid-doża NOEL (3 mg/kg/jum), l-AUCs għal anagrelide u l-metaboliti BCH24426 u RL603 kienu 14-il darba, darbtejn u darbtejn ogħla mill-AUC fi bnedmin li ngħataw doża orali ta' anagrelide ta' 2 mg/jum.
English: The average total daily dose of anagrelide across all studies in paediatric ET patients was highly variable, but overall the data suggest that adolescents could follow similar starting and maintenance doses to adults and that a lower starting dose of 0.5 mg/day would be more appropriate for children over 6 years (see sections 4.2, 4.4, 4.8, 5.2).
Maltese: Il-medja tad-doża totali ta' kuljum ta' anagrelide fl-istudji kollha f'pazjenti pedjatriċi b'ET kienet varjabbli ħafna, iżda globalment id-dejta tissuġġerixxi li l-adolexxenti jistgħu jsegwu dożi simili talbidu u ta' manteniment bħall-adulti, u li doża tal-bidu iktar baxxa ta' 0.5 mg/jum tkun iktar adattata għal tfal ta' aktar minn 6 snin (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.2).
English: • Fluvoxamine, used to treat depression;
Maltese: • Fluvoxamine, li jintuża biex jikkura d-dipressjoni;
English: In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x
Maltese: F'pazjenti b'tromboċitemja essenzjali, respons komplut kien definit bħala tnaqqis fl-għadd tal-plejtlets għal ≤ 600 x 10
English: Flu-like syndrome Pain
Maltese: Sindrome qisu influwenza Uġigħ
English: Angina pectoris Postural hypotension Vasodilatation
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Myocardial infarction Cardiomyopathy Cardiomegaly Pericardial effusion
Maltese: Potenzjal mutaġeniku u karċinoġeniku
English: • Acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin);
Maltese: • Acetylsalicylic acid (sustanza li tinsab f'ħafna mediċini li jiintużaw għal-uġigħ u biex jitnaqqas id-deni, kif ukoll għall-prevenzjoni ta' tagħqid tad-demm, magħrufa wkoll bħala aspirina);
English: Nausea Flatulence
Maltese: Tiħux Xagrid
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III (PDE III).
Maltese: Dawn ir-reazzjonijiet avversi tal-mediċina huma mistennija skond il-farmakoloġija ta' anagrelide (inpediment ta' PDE III).
English: • Certain types of antibiotic, such as enoxacin, used to treat infections;
Maltese: • Ċertu tip ta' antibijotiċi, bħal enoxacin, li jintuża biex jikkura infezzjonijiet;
English: Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, such as congenital long QT syndrome, a known history of acquired QTc prolongation, medicinal products that can prolong QTc interval and hypokalaemia.
Maltese: Għandu jkun hemm kawtela meta tuża anagrelide f'pazjenti b'fatturi ta' riskju magħrufa għal titwil tal-intervall tal-QT, bħas-sindrome konġenitali ta' QT twil, storja medika magħrufa ta' titwil tal-QTc akkwistat, prodotti mediċinali li jistgħu jtawwlu l-intervall tal-QTc u ipokalemija.
English: • CYP1A2 inducers (such as omeprazole) could decrease the exposure of anagrelide increasing its main active metabolite.
Maltese: • Indutturi ta' CYP1A2 (bħal omeprazole) jistgħu jnaqqsu l-esponiment ta' anagrelide, u jżidu lmetabolit attiv tiegħu.
English: 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.
Maltese: Dożi ta' anagrelide li huma tossiċi fil-maternita' fil-firien u fil-fniek kienu assoċjati ma żieda firrisorbiment ta' l-embriju u tal-mortalità tal-fetu.
English: Uncommon: Heart failure (signs include shortness of breath, chest pain, swelling of the legs due to fluid build-up), severe problem with the rate or rhythm of the heart beat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas which causes severe abdominal and back pain (pancreatitis), vomiting blood or passing bloody or black stools, severe reduction in blood cells which can cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling in legs or ankles, and lips and skin can turn bluish colour) .
Maltese: Mhux komuni: Insuffiċjenza tal-qalb (sinjali jinkludu qtugħ tan-nifs, uġigħ fis-sider, nefħa fis-saqajn minħabba akkumulazzjoni ta' fluwidu), problema serja bit-rata jew ritmu ta' taħbit tal-qalb (takikardija ventrikulari, takikardija supraventrikulari jew fibrillazzjoni atrijali), infjammazzjoni talfrixa li tikkawża wġigħ ta' żaqq qawwi u wġigħ ta' dahar (pankreatite), tirremetti d-demm, jew ikollok ippurgar bid-demm jew iswed, tnaqqis sever fiċ-ċelluli tad-demm li jista' jikkawża dgħufija, tbenġil, ħruġ ta' demm jew infezzjonijiet (panċitopenija), pressjoni tad-demm pulmonari għolja (is-sinjali jinkludi qtugħ ta' nifs, infiħ tar-riġlejn jew l-għekiesi, u x-xufftejn u l-ġilda jistgħu jsiru ta' kulur blu).
English: 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.
Maltese: 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.
English: In female rats, using doses in excess of the therapeutic range, anagrelide disrupted implantation (see section 5.3).
Maltese: F'firien nisa, bl-użu ta' dożi ogħla mill-medda terapewtika, anagrelide fixkel l-impjantazzjoni (ara sezzjoni 5.3).
English: • Theophylline, used to treat severe asthma and breathing problems;
Maltese: • Theophylline, li jintuża biex jikkura problemi severi ta' l-ażżma u tan-nifs;
English: Other medicines and Xagrid
Maltese: Kif taħżen Xagrid
English: In case of overdose, close clinical supervision of the patient is required; this includes monitoring of the platelet count for thrombocytopenia.
Maltese: F'każ ta' doża eċċessiva, sorveljanza klinika millqrib hija meħtieġa; din tinkludi monitoraġġ ta' l-għadd tal-plejtlets għat-tromboċitopenja.
English: Xagrid contains lactose
Maltese: Tossiċità ta' dożi rrepetuti
English: A single 5 mg dose of anagrelide can lead to a fall in blood pressure usually accompanied by dizziness.
Maltese: Doża waħda ta' 5 mg ta' anagrelide tista' twassal għal tnaqqis fil-pressjoni tad-demm normalment akkompanjata minn sturdament.
English: • Oral contraceptives: If you experience bad diarrhoea whilst taking this medicine, it may reduce how well the oral contraceptive works and use of an extra method of contraception is recommended (e.g condom).
Maltese: • Kontraċettivi orali: Jekk ikollok dijarea qawwija waqt li tkun qed tieħu din il-mediċina, din tista' tnaqqas kemm jaħdem tajjeb il-kontraċettiv orali, u l-użu ta' metodu ieħor addizzjonali ta'
English: INFORMATION IN BRAILLE
Maltese: Insuffiċjenza talkliewi
English: However, safety data are limited and do not allow a meaningful comparison between adult and paediatric patients to be made (see section 4.4).
Maltese: Madankollu, iddejta dwar is-sigurtà hi limitata u ma tippermettix li jsir paragun sinifikanti bejn pazjenti adulti u pedjatriċi (ara sezzjoni 4.4).
English: In the later study 3660 patients who received anagrelide at a mean dose of approximately 2 mg/day were assessed for safety.
Maltese: Fi studju li sar aktar tard 3660 pazjent li rċevew anagrelide f'doża medja ta' madwar 2 mg/jum ġew assessjati għas-sigurtà.
English: Food also decreased the Cmax of the active metabolite, 3-hydroxyanagrelide, by 29%, although it had no effect on the AUC.
Maltese: L-ikel ukoll naqqas is-Cmax tal-metabolit attiv 3-hydroxy-anagrelide b'29%, għalkemm ma kellu l-ebda effett fuq l-AUC.