FrancophonIA/ELRC3.0 huggingface dataset:
English: Within the system organ classes they are listed under the following headings: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Rari (≥ 1/10,000 sa < 1/1,000);
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX35.
Maltese: Sustanzi antineoplastiċi oħrajn, Kodiċi ATC:
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
Maltese: Anagrelide hu impeditur ta' AMP phosphodiesterase
English: Pancytopenia Thrombocytopenia Haemorrhage Ecchymosis
Maltese: Sindrome li tixbaħ linfluwenza Uġigħ Astenja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1256/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1256/002
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 trattament b'anagrelide fil-passat jew li kienu qed jirċievu anagrelide għal sa 5 snin qabel l-istudju), l-għadd medjan tal-plejtlits naqas għal livelli kkontrollati wara 12-il ġimgħa ta' trattament.
English: Show them the pack of Anagrelide Mylan.
Maltese: Urihom il-pakkett ta' Anagrelide Mylan.
English: NAME OF THE MEDICINAL PRODUCT Anagrelide Mylan 0.5 mg hard capsules Anagrelide Mylan 1 mg hard capsules
Maltese: Anagrelide Mylan 0.5 mg kapsuli ibsin Anagrelide Mylan 1 mg kapsuli ibsin
English: • Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone,
Maltese: • Mediċini li jintużaw biex jittrattaw disturbi tal-qalb, pereżempju, milrinone, enoximone,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1256/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1256/001
English: • > 60 years of age or
Maltese: • >'il fuq minn 60 sena jew
English: Care should also be taken in populations that may have a higher maximum plasma concentration (Cmax) of anagrelide or its active metabolite, 3-hydroxy-anagrelide, e.g. hepatic impairment or use with CYP1A2 inhibitors (see section 4.5).
Maltese: Għandu jkun hemm attenzjoni wkoll f'popolazzjonijiet li jista' jkollhom konċentrazzjoni massima ogħla fil-plażma (Cmax) ta' anagrelide jew tal-metabolit attiv tiegħu, 3-hydroxy-anagrelide, eż. indeboliment tal-fwied jew l-użu ma' inibituri ta' CYP1A2 (ara sezzjoni 4.5).
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 firrata 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 għal 2.5 mg.
English: At the NOEL dose (3 mg/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 2 mg/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 no observed effect level (NOEL) for male dogs (0.3 mg/kg/day) corresponds to 0.1, 0.1, and 1.6-fold the AUC in humans for anagrelide at 2 mg/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 l-metaboliti BCH24426 u RL603, rispettivament.
English: The plasma half-life of anagrelide is short, approximately 1.3 hours and as expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Maltese: Il-half-life fil-plażma hija qasira, madwar 1.3 sigħat, u kif mistenni mill-half-life tiegħu, m'hemm l-ebda evidenza ta' akkumulazzjoni ta' anagrelide fil-plażma.
English: Anagrelide Mylan is available in plastic bottles of 30 ml or 75 ml with a tamper evident, child-resistant closure and a desiccant.
Maltese: Anagrelide Mylan hu disponibbli fi fliexken tal-plastik ta' 30 mL jew 75 mL, b'għatu li ma jinfetaħx mit-tfal u kontra t-tbagħbis u dessikant.
English: 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.
Maltese: F'pazjenti b'tromboċitemja essenzjali, rispons komplut kien definit bħala tnaqqis fl-għadd tal-plejtlets għal ≤ 600 x 109/l jew tnaqqis ta' ≥ 50% mil-linja bażi ta' riferimet u żamma tat-tnaqqis għal tal-anqas 4 ġimgħat.
English: Anagrelide Mylan contains lactose
Maltese: Kif jidher Anagrelide Mylan u l-kontenut tal-pakkett
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 l-metabolit attiv tiegħu.
English: Pulmonary hypertension Pneumonia Pleural effusion Dyspnoea Epistaxis
Maltese: Pressjoni tad-demm pulmonari għolja
English: The reference medicinal product containing anagrelide has been authorised under “exceptional circumstances”.
Maltese: Il-prodott mediċinali ta' referenza li fih anagrelide ġie awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: Capsule shell
Maltese: U KONTENUT Kapsula iebsa
English: In male rats, anagrelide at oral doses up to 240 mg/kg/day (> 1,000 times a 2 mg/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 (>1,000 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: Each hard capsule contains anagrelide hydrochloride monohydrate equivalent to 0.5 mg anagrelide.
Maltese: Kull kapsula fiha anagrelide hydrochloride monohydrate ekwivalenti għal 0.5 mg ta' anagrelide.
English: Limited pharmacokinetic and/or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted.
Maltese: Saru għadd limitat ta' studji farmakokinetiċi u/jew farmakodinamiċi li jistħarrġu r-reazzjonijiet possibbli bejn anagrelide u prodotti mediċinali oħrajn.
English: Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1 mg/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: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Anagrelide Mylan fih il-lactose Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' lactase totali jew malassorbiment tal-glucose-galactose, m'għandhomx jieħdu din il-mediċina.
English: A transient increase in mean QTc was observed for both doses during periods of increasing heart rate and the maximum change in mean QTcF (Fridericia correction) was +5.0 msec occurring at 2 hours for 0.5 mg and +10.0 msec occurring at 1 hour for 2.5 mg.
Maltese: Ġiet osservata żieda temporanja fil-medja tal-QTc għaż-żewġ dożi matul perjodi ta' żieda fir-rata ta' taħbit tal-qalb, u l-bidla massima fil-medja tal-QTcF (korrezzjoni Fridericia) kienet ta' +5.0 msek li seħħet wara sagħtejn għal 0.5 mg u +10.
English: Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking anagrelide.
Maltese: Nisa li huma f'riskju li jinqabdu tqal għandhom ikunu ċerti li qed jużaw kontraċezzjoni effettiva meta jieħdu Xagrid.
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III (PDE III).
Maltese: Dawn ir-reazzjonijiet avversi għall-mediċina huma mistennija skont il-farmakoloġija ta' anagrelide (inpediment ta' PDE III).
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Maltese: Ara l-istruzzjonijiet fil-fuljett ta' tagħrif tal pillola kontraċettiva li tkun qed tieħu.
English: Nausea Flatulence
Maltese: Żieda fl-enżimi talfwied
English: After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 109/l and ideally at levels between 150 x 109/l and 400 x 109/l.
Maltese: Wara ġimgħa d-doża għandha tiġi mibdula fuq bażi individwali, biex tinkiseb l-anqas doża effettiva meħtieġa biex tnaqqas u/jew iżżomm l-għadd tal-plejtlets għal anqas minn 600 x 109/l u idealment f'livelli bejn 150 x 109/l u 400 x 109/l.
English: Colitis Gastritis Gingival bleeding
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains anagrelide hydrochloride monohydrate equivalent to 0.5 mg anagrelide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kapsula iebsa fiha anagrelide hydrochloride monohydrate ekwivalenti għal 0.5 mg ta' anagrelide.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Anagrelide Mylan 0.5 mg hard capsules
Maltese: U KWANTITATTIVA Anagrelide Mylan 0.5 mg kapsuli ibsin
English: Atrial fibrillation Supraventricular tachycardia Arrhythmia Hypertension Syncope
Maltese: Effetti ta' sustanzi attivi oħrajn fuq anagrelide
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-maternità fil-firien u fil-fniek kienu assoċjati ma żieda firrisorbiment tal-embriju u tal-mortalità tal-fetu.
English: Effects on heart rate and QTc interval
Maltese: Effetti fuq ir-rata ta' taħbit tal-qalb u l-intervall tal-QTc
English: Each hard capsule contains anagrelide hydrochloride monohydrate equivalent to 1 mg anagrelide.
Maltese: Kull kapsula fiha anagrelide hydrochloride monohydrate ekwivalenti għal 1 mg ta' anagrelide.
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 li għandhom iktar minn 6 snin (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.2).
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
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 Anagrelide Mylan”);
English: The effect of two dose levels of anagrelide (0.5 mg and 2.5 mg single doses) on the heart rate and QTc interval was evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy adult men and women.
Maltese: L-effett ta' żewġ livelli ta' doża ta' anagrelide (dożi singoli ta' 0.5 mg u 2.5 mg) fuq ir-rata ta' taħbit tal-qalb u l-intervall tal-QTc ġie evalwat fi studju double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo u b'mod attiv, tat-tip cross-over, li sar fuq irġiel u nisa adulti b'saħħithom.
English: Marketing Authorisation Holder Mylan S.A.S
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Mylan S.A.S
English: Each bottle contains 100 hard capsules.
Maltese: Kull flixkun fih 100 kapsula iebsa.
English: Uncommon side effects: may affect up to 1 in 100 people 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',
Maltese: Effetti sekondarji mhux komuni: jistgħu jaffettwaw sa 1 minn kull 100 persuna Tħossok debboli jew ma tħossokx ftiegħek, pressjoni għolja tad-demm, taħbit tal-qalb irregolari, ħass ħażin, tertir ta' bard 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, tinfaraġ, infezzjoni serja fil-pulmun bid-deni, qtugħ ta' nifs, sogħla,
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains anagrelide hydrochloride monohydrate equivalent to 1 mg anagrelide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kapsula iebsa fiha anagrelide hydrochloride monohydrate ekwivalenti għal 1 mg ta' anagrelide.
English: In combination with 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), there is an increased risk of major haemorrhages (bleeding) (see section “Other medicines and Anagrelide Mylan”).
Maltese: Flimkien ma' acetylsalicylic acid (sustanza li tinsab f'ħafna mediċini li jintużaw għall-uġigħ u biex jitnaqqas id-deni, kif ukoll għall-prevenzjoni ta' tagħqid tad-demm, magħrufa wkoll bħala aspirina), hemm żieda fir-riskju ta' emorraġiji serji (ħruġ ta' demm) (ara sezzjoni “Mediċini oħra u Anagrelide Mylan”).
English: Uterine adenocarcinomas, of epigenetic origin, could be related to an enzyme induction of CYP1 family.
Maltese: Adenokarċinomi fl-utru, ta' oriġini epiġenetika, jistgħu jkunu marbuta ma' induzzjoni ta' enżima tal-familja CYP1.
English: Patients with moderate or severe hepatic impairment.
Maltese: Pazjenti b'indeboliment epatiku moderat jew serju.
English: Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Maltese: Anagrelide Mylan fih l-istess sustanza attiva u jaħdem fl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-UE.
English: Diarrhoea Vomiting Abdominal pain
Maltese: Studji dwar l-iżvilupp embrijufetali
English: The observed pharmacokinetic differences between elderly and young patients with ET (see section 5.2) do not warrant using a different starting regimen or different dose titration step to achieve an individual patient-optimised anagrelide regimen.
Maltese: Id-differenzi farmakokinetiċi osservati bejn pazjenti anzjani u żgħażagħ bl-ET (ara sezzjoni 5.2) ma jiġġustifikawx l-użu ta' kors tal-bidu differenti jew pass differenti tat-titrazzjoni tad-doża biex jittwettaq kors ta' anagrelide li jkun ottimizzat għall-pazjent individwali.
English: Food also decreased the Cmax of the active metabolite, 3-hydroxy-anagrelide, 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.
English: Very common side effects: may affect more than 1 in 10 people Headache.
Maltese: Effetti sekondarji komuni ħafna: jistgħu jaffettwaw iktar minn persuna 1 f'10 Uġigħ ta' ras.
English: GENERAL CLASSIFICATION FOR SUPLY
Maltese: KLASSIFIKAZZJONI ĠENERALI
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 jintużaw għall-uġigħ u biex jitnaqqas id-deni, kif ukoll għall-prevenzjoni ta' tagħqid tad-demm, magħrufa wkoll bħala aspirina);
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 tal-għadd tal-plejtlets għat-tromboċitopenja.
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), increased pressure in the lung arteries (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 tal-frixa 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), żieda fil-pressjoni fl-arterji tal-pulmun (is-sinjali jinkludi qtugħ ta' nifs, nefħa fir-riġlejn u fl-għekiesi u x-xufftejn u l-ġilda jistgħu jsiru ta' kulur blu).
English: Sant Boi de Llobregat
Maltese: F'dan il-fuljett
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 tal-espożizzjoni tal-AUC fil-bniedem wara doża ta' 1 mg darbtejn kuljum.
English: Common side effects: may affect up to 1 in 10 people Dizziness, tiredness, rapid heart beat, irregular or strong heartbeat (palpitations), feeling sick (nausea), diarrhoea, stomach pain, wind, being sick (vomiting), reduction in red blood cell count (anaemia), fluid retention or rash.
Maltese: Effetti sekondarji komuni: jistgħu jaffettwaw sa 1 minn kull 10 persuni Sturdament, għeja, taħbit tal-qalb mgħaġġel, taħbit tal-qalb irregolari jew qawwi (palpitazzjonijiet), tħossok imdardar (dardir), dijarea, uġigħ fl-istonku, indiġestjoni u gass, tirremetti (rimettar), tnaqqis żgħir fl-għadd ta' ċelluli ħomor tad-demm (anemija), akkumulazzjoni ta' fluwidu jew raxx.
English: Available data in animals have shown excretion of anagrelide/metabolites in milk.
Maltese: Dejta flannimali uriet li kien hemm eliminazzjoni ta' anagrelide/metaboliti fil-ħalib tas-sider.
English: In female rats increases in pre- and post-implantation losses and a decrease in the mean number of live embryos was observed at 30 mg/kg/day.
Maltese: F'firien nisa, żidiet fit-telf qabel u wara l-impjantazzjoni u żieda fil-medja tan-numru ta' embriji ħajjin, ġew osservati f'doża ta' 30 mg/kg/jum.
English: It is unknown whether anagrelide/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk anagrelide/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: The lowest dose in males (3 mg/kg/day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
Maltese: L-inqas doża f'dawk maskili (3 mg/kg/kuljum) tikkorrispondi għal 37 darba tal-espożizzjoni tal-AUC fil-bniedem wara doża ta' 1 mg darbtejn kuljum.
English: A pre-treatment cardiovascular examination, including a baseline ECG and echocardiography is recommended for all patients prior to initiating therapy with anagrelide.
Maltese: Eżami kardjovaskulari qabel it-trattament, li jinkludi ECG fil-linja bażi u ekokardjografija hu rakkomandat għall-pazjenti kollha qabel ma tinbeda t-terapija b'anagrelide.
English: Repeated dose toxicity
Maltese: Tossiċità ta' dożi rrepetuti
English: EMA/477286/2015 EMEA/H/C/001112
Maltese: EMA/H/C/001112
English: It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; and 300 mg irbesartan and 25 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli, b'forma ta' kapsula (150 mg jew 300 mg irbesartan u 12.5 mg idroklorotijażid; u irbesartan 300 mg u 25 mg idroklorotijażid).
English: Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Maltese: Mhumiex rakkomandati dożi ogħla minn 300 mg irbesartan jew 25 mg idroklorotijażid darba kuljum.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan/Hydrochlorothiazide Teva on 26 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Irbesartan/Hydrochlorothiazide Teva valida fl-UE kollha fis-26 ta' Novembru 2009.
English: Irbesartan/Hydrochlorothiazide Teva is a ‘generic medicine'.
Maltese: Irbesartan/Hydrochlorothiazide Teva huwa ‘mediċina ġenerika'.
English: Because Irbesartan/Hydrochlorothiazide Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel.
Maltese: Billi Irbesartan/Hydrochlorothiazide Teva huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, CoAprovel.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan/Hydrochlorothiazide Teva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Irbesartan/Hydrochlorothiazide Teva.
English: Irbesartan/Hydrochlorothiazide Teva irbesartan and hydrochlorothiazide
Maltese: Irbesartan/Hydrochlorothiazide Teva irbesartan u idroklorotijażid
English: This means that Irbesartan/Hydrochlorothiazide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called CoAprovel.
Maltese: Dan ifisser li Irbesartan/Hydrochlorothiazide Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata flUnjoni Ewropea (UE) li jisimha CoAprovel.
English: The CHMP concluded that, in accordance with EU requirements, Irbesartan/Hydrochlorothiazide Teva has been shown to have comparable quality and to be bioequivalent to CoAprovel.
Maltese: Il-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Irbesartan/Hydrochlorothiazide Teva ntwera li għandu kwalità komparabbli u huwa bijoekwivalenti ma' CoAprovel.
English: Irbesartan/Hydrochlorothiazide Teva contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Irbesartan/Hydrochlorothiazide Teva fih żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażid.
English: What is Irbesartan/Hydrochlorothiazide Teva?
Maltese: Għal xiex jintuża Irbesartan/Hydrochlorothiazide Teva?