FrancophonIA/ELRC3.0 huggingface dataset:
English: No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted.
Maltese: Ma kienet osservata lebda bidla fl-espożizzjoni għal carbamazepine jew il-metabolit tiegħu carbamazepine-epoxide.
English: Exalief 600 mg tablets are packed in HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Maltese: Pilloli Exalief 600 mg huma ppakkjati fi fliexken HDPE b'għatu li ma jinfetaħx mit-tfal, impoġġijin f'kaxex tal-kartun, li fihom 90 pillola.
English: Exalief 800 mg tablets are packed in HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Maltese: Pilloli Exalief 800 mg huma ppakkjati fi fliexken HDPE b'għatu li ma jinfetaħx mit-tfal, impoġġijin f'kaxex tal-kartun, li fihom 90 pillola.
English: Based on individual response, the dose may be increased to 1200 mg once daily (see section 5.1).
Maltese: Id-doża tista' tiżdied għal 1200 mg darba kuljum, abbażi tar-reazzjoni individwali (ara sezzjoni 5.1).
English: Eslicarbazepine acetate was evaluated in rats and mice for potential adverse effects on fertility of the parental and F1 generation.
Maltese: Eslicarbazepine acetate ġie evalwat fil-firien u fil-ġrieden għal effetti avversi potenzjali fuq il-fertilità talġenituri u ta' ġenerazzjoni F1.
English: The tablets are packaged in blisters in cardboard boxes containing 7, 14 or 28 tablets.
Maltese: Il-pilloli huma ppakkjati f'folji f'kaxxi tal-kartun li fihom 7, 14 jew 28 pilloli.
English: Monitoring and prevention
Maltese: Monitoraġġ u prevenzjoni
English: In patients with CLCR <30 ml/min use is not recommended due to insufficient data.
Maltese: F'pazjenti b'CLCR <30 ml/min, l-użu mhuwiex rakkomandat minħabba nuqqas ta' dejta.
English: Liver centrilobular hypertrophy was seen in repeated dose toxicity studies in mice and rats and an increased incidence of liver tumours was observed in the carcinogenicity study in mice; these findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving eslicarbazepine acetate.
Maltese: Ipertrofija ċentrilobulari tal-fwied dehret fl-istudji tat-tossiċità ta' doża ripetuta fil-ġrieden u fil-firien u ġiet osservata żieda fl-inċidenza ta' tumuri tal-fwied fl-istudju tal-karċinoġeniċità fil-ġrieden; dawn is-sejbiet huma konsistenti ma' induzzjoni ta' enzimi mikrosomali tal-fwied, effett li ma ġiex osservat f'pazjenti li jirċievu eslicarbazepine acetate.
English: • Do not take oxcarbazepine (a medicine used to treat epilepsy) with Exalief, as it is not known whether it is safe to take these medicines together.
Maltese: • Tiħux oxcarbazepine (mediċina użata biex tikkura l-epilessija) ma' Exalief, minħabba li mhuwiex magħruf jekk huwiex perikoluż li tieħu dawn il-mediċini flimkien.
English: Alopecia, dry skin, hyperhidrosis, erythema, nail disorder, skin disorder
Maltese: Alopixja, ġilda xotta, iperidrożi, eritima, disturb tad-dwiefer, disturb tal-ġilda
English: The usual maintenance dose is 800 mg once daily.
Maltese: Id-doża ta' manteniment tas-soltu hija 800 mg darba kuljum.
English: The pharmacokinetics of eslicarbazepine has not been evaluated in patients with severe hepatic impairment (see section 4.4 and 5.2) and use in these patients is therefore not recommended.
Maltese: Il-farmakokinetiċi ta' eslicarbazepine ma ġewx evelwati f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.4 u 5.2) u għaldaqstant, l-użu f'dawn il-pazjenti mhuwiex rakkomandat.
English: Headache, abnormal coordination disturbance in attention, tremor
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Maltese: Kura multipla bi prodott mediċinali kontra l-epilessija tista' tkun assoċjata ma' riskju ogħla ta' malformazzjonijiet konġenitali milli b'monoterapija, għaldaqstant huwa importanti li kull fejn possibbli, tiġi pprattikata monoterapija.
English: Method and route of administration Swallow the tablet with a glass of water.
Maltese: Metodu u rotta ta' mnejn jingħata Ibla' l-pillola ma' tazza ilma.
English: Palpitations, bradycardia, sinus bradycardia
Maltese: Uġigħ fil-widnejn, hypoacusis, tinnitus
English: White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side.
Maltese: Pilloli bojod tondi bikonvessi, imnaqqxin b'‘ESL 400' fuq naħa waħda u mnaqqxin b'sinjal fuq in-naħa l-oħra.
English: • Worsening of seizures
Maltese: • Diffikultà fid-diskors
English: • Shaking
Maltese: • Guffaġni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14 or 28 tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' 7, 14 jew 28 pillola
English: Thus, interactions can arise when coadministering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19.
Maltese: Għaldaqstant, jista' jkun hemm interazzjonijiet meta dożi għoljin ta' eslicarbazepine acetate jingħataw fl-istess ħin ma' prodotti mediċinali li huma metabolizzati b'mod ewlieni minn CYP2C19.
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side.
Maltese: Pilloli bojod tawwalin, imnaqqxin b'‘ESL 600' fuq naħa waħda u mnaqqxin b'sinjal fuq in-naħa l-oħra.
English: Based on a structural relationship of eslicarbazepine acetate to tricyclic antidepressants, an interaction between eslicarbazepine acetate and MAOIs is theoretically possible.
Maltese: Effett fuq xulxin bejn eslicarbazepine u MAOIs huwa teoretikament possibbli, ibbażat fuq ir-relazzjoni strutturali ta' eslicarbazepine acetate għal anti-depressanti triċikliċi.
English: • Skin rash
Maltese: • Ikollok pirjids irregolari
English: Eslicarbazepine acetate adversely interacts with oral contraceptives.
Maltese: Eslicarbazepine acetate jinteraġġixxi b'mod avvers ma' kontraċettivi orali.
English: • Headache
Maltese: • Farġa
English: Safety margins based on comparative exposure have thus not been established.
Maltese: Għaldaqstant għadu ma ġiex stabbilit marġini ta' sigurtà bbażat fuq espożizzjoni komparattiva.
English: Blood pressure decreased, weight decreased, blood pressure diastolic decreased, blood pressure increased, blood pressure systolic decreased, blood sodium decreased, haematocrit decreased, haemoglobin decreased, heart rate increased, transaminases increased, triglycerides increased, triiodothyronine (T3) free decreased, thyroxine (T4) free decreased
Maltese: Tnaqqis fil-pressjoni taddemm, tnaqqis fil-piż, tnaqqis fil-pressjoni taddemm dijastolika, żieda fil-pressjoni tad-demm, tnaqqis fil-pressjoni taddemm sistolika, tnaqqis fis-sodju fid-demm, tnaqqis fl-ematokrit, tnaqqis fl-emoglobina, żieda fir-rata tal-qalb, żieda fittransaminases, żieda fittrigliċeridi, tnaqqis f'triiodothyronine (T3) ħieles, tnaqqis f'thyroxine (T4) ħieles
English: In the mouse, the overall incidence of major abnormalities and the incidence for major skeletal abnormalities were increased.
Maltese: Fil-ġrieden, l-inċidenza totali ta' anormalitajiet maġġuri u linċidenza għal anormalitajiet skeletriċi maġġuri żdiedu.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u l-attivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deciż fl-verżjoni 4.0 tas-Sistema ta' l-Immaniġġar tar-Riskju inkluz f' Modulu 1.8.2 tal- Applikazzjoni għall-awtorizzazzjoni għat-Tqegħid fis-Suq Applikazzjoni u aġġornamenti sussegwenti tas-Sistema ta' l-Immaniġġar tar-Riskju kif deciż mill-Kumitat ghall-Prodotti Mediċinali għall-Użu Uman ta' l-Aġenzija Ewropeja dwar il-Mediċini (CHMP).
English: Each tablet contains 800 mg of eslicarbazepine acetate.
Maltese: Exalief 800 mg pilloli Eslicarbazepine acetate
English: Elderly (over 65 years of age) If you are elderly your doctor will decide the suitable dose for you.
Maltese: Anzjani (età aktar minn 65 sena) Jekk inti anzjan it-tabib tiegħek jiddeċiedi d-doża addattata għalik.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate.
Maltese: Il-mekkaniżmu ta' dan irriskju mhuwiex magħruf u d-dejta disponibbli ma teskludix il-possibbilità ta' żieda fir-riskju għal eslicarbazepine acetate.
English: Apart from this, sodium levels should be determined during routine laboratory examination.
Maltese: Apparti dan, il-livelli tassodju għandhom jiġu stabbiliti matul eżami tal-laboratorju ta' rutina.
English: Concomitant use of Exalief with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.
Maltese: Użu konkomittanti ta' Exalief ma' oxcarbazepine mhuwiex rakkomandat minħabba li dan jista' jikkaġuna esponiment żejjed għall-metaboliti attivi.
English: Oxcarbazepine and felbamate were not allowed as concomitant medicinal products in these studies.
Maltese: Oxcarbazepine u felbamate ma tħallewx bħala prodotti mediċinali konkomittanti f'dawn l-istudji.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fiż-żmien 60 jum ta' meta għandu jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskju);
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Maltese: L-aktar li jiġu rrapportati huma qasma fix-xoffa, malformazzjonijiet kardjovaskulari u difetti fit-tubu newrali.
English: • Disturbances in the sense of smell and/or tasting
Maltese: • Disturbi fis-sens tax-xamm u/jew tat-togħma
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4.Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with Exalief.
Maltese: Għaldaqstant, tista' tkun meħtieġa żieda fid-doża tal-prodotti mediċinali li jkunu primarjament metabolizzati permezz ta' CYP3A4, meta jintuża fl-istess ħin ma' Exalief.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/007-011
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/520/007-011
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' 30 jew 60 pillola
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/001-006
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/520/001-006
English: • Tell your doctor if you are taking tricyclic antidepressants e.g. amitriptyline.
Maltese: • Għid lit-tabib tiegħek jekk qed tieħu antidepressanti triċikliki ngħidu aħna, amitriptyline.
English: In a fertility study in mice, developmental effects were observed in embryos; however, effects could also result from lower corpora lutea count and thus show impairment of fertility.
Maltese: Fi studju dwar il-fertilità fil-ġrieden, kienu osservati effetti waqt liżvilupp fl-embriji; madankollu, l-effetti jistgħu jirriżultaw ukoll minn għadd iktar baxx ta' corpora lutea u għaldaqstant juru indeboliment fil-fertilità.
English: The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Maltese: Il-pilloli huma ppakkjati f'folji f'kaxxi tal-kartun li fihom 30 jew 60 pilloli, u fi fliexken tal-HDPE b'għatu li ma jistax jinfetaħ mit-tfal f'kaxxi tal-kartun li fihom 90 pillola.
English: Evidence of nephrotoxicity was observed in repeated dose toxicity studies in the rat, but was not seen in studies in mice or dogs, and is consistent with an exacerbation of spontaneous chronic progressive nephropathy in this species.
Maltese: Evidenza ta' nefrotossiċità ġiet osservata fi studji ta' tossiċità ta' doża ripetuta fil-firien, iżda din ma dehritx fi studji fuq il-ġrieden jew il-klieb, u hija konsistenti mat-taħrix ta' nefropatija progressiva kronika spontaneja f'din l-ispeċi.
English: If signs or symptoms of hypersensitivity develop, Exalief must be discontinued.
Maltese: Exalief għandu jitwaqqaf, jekk jiżviluppaw sinjali u sintomi ta' sensittività eċċessiva.
English: • Hair loss
Maltese: • KUNDIZZJONIJIET OĦRA
English: • Cold limbs
Maltese: • Problemi tal-fwied
English: Exalief 800 mg tablets are white and oblong.
Maltese: Pilloli Exalief 800 mg huma bojod u tawwalin.
English: However, Exalief is not recommended if you have severe liver problems.
Maltese: Exalief mhuwiex rakkomandat jekk inti għandek problemi serji fil-kliewi.
English: • Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures.
Maltese: • Disturb newroloġiku fil-moviment, fejn il-muskoli jinġibdu u jikkawżaw tgħawwiġ u movimenti ripetittivi jew qagħdiet skomdi.
English: Rzymowskiego 28 02-697 Warszawa Poland
Maltese: Rzymowskiego 28 02-697 Warszawa Polond
English: s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic
Maltese: s r.o., Stroupežnického 17, 150 00 Prague 5,
English: Magnesium stearate Hydroxypropyl cellulose Amylum pregelificatum Mannitol (E421) Aspartame (E951) Sucralose (E955) Grape flavour
Maltese: Magnesium stearate Hydroxypropyl cellulose Amylum pregelificatum Mannitol (E421) Aspartame (E951) Sucralose (E955) Togħma tal-għeneb
English: Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg
Maltese: Pfizer Luxembourg SARL, 51, Avenue J. F.
English: Each {PRODUCT NAME} 10 mg chewable tablet contains 1.25 mg aspartame.
Maltese: TAL-PRODOTT} 10 mg pillola li tomgħodha fiha 1.25 mg aspartame.
English: Cohort B included 24 children, 10 to 17 years of age and at Tanner Stage ≥2.
Maltese: Grupp B kien jikkonsisti minn 24 tifel u tifla, minn 10 sa 17-il sena u f'Tanner Stage ≥2.
English: Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Maltese: Atorvastatin naqqas b'mod sinifikanti l-livelli ta' C-totali, LDL-C, trigliċeridi u apolipoproteina B fil-plażma matul il-fażi double-blind ta' 26 ġimgħa.
English: The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26-week double-blind phase.
Maltese: Ilvalur medju miksub ta' LDL-C kien 3.38 mmol/l (medda: 1.81-6.26 mmol/l) fil-grupp ta' atorvastatin meta mqabbel ma' 5.91 mmol/l (medda: 3.93-9.96 mmol/l) fil-grupp tal-plaċebo matul il-fażi double-blind ta' 26 ġimgħa.
English: Pfizer, spol.
Maltese: Repubblika Ċeka Pfizer, spol.
English: Each {PRODUCT NAME} 20 mg chewable tablet contains 2.5 mg aspartame.
Maltese: TAL-PRODOTT} 20 mg pillola li tomgħodha fiha 2.5 mg aspartame.
English: [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: {Isem u indirizz} <{tel}> <{fax}> <{e-mail}>
English: In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively.
Maltese: Fi studju open-label ta' 8 ġimgħat, pazjenti tfal Tanner Stage 1 (N=15) u Tanner Stage ≥2 (N=24) (etajiet minn 6 -17-il sena) b'iperkolesterolemija eterożigota familjali u LDL-C fillinja bażi ta' ≥4 mmol/L ġew ikkurati b'5 jew 10 mg ta' pilloli atorvastatin li tomgħodhom jew 10 jew 20 mg ta' pilloli atorvastatin miksijin b'rita darba kuljum, rispettivament.
English: LIST OF EXCIPIENTS Contains aspartame.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih l-aspartame.
English: Each {PRODUCT NAME} 40 mg chewable tablet contains 5 mg aspartame.
Maltese: TAL-PRODOTT} 40 mg pillola li tomgħodha fiha 5 mg aspartame.
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola li tomgħodha
English: FURTHER INFORMATION
Maltese: TAL-PRODOTT} Aktar informazzjoni
English: An additional paediatric study of atorvastatin versus colestipol in patients with hypercholesterolaemia aged 10-18 years demonstrated that atorvastatin (N=25) caused a significant reduction in LDL-C at week 26 (p<0.05) compared with colestipol (N=31).
Maltese: Studju addizzjonali ta' atorvastatin kontra colestipol f'pazjenti tfal ta' 10-18-il sena b'iperkolesterolemija wera li atorvastatin (N=25) ikkawża tnaqqis sinifikanti fil-LDL-C f'ġimgħa 26 (p<0.05) meta mqabbel ma' colestipol (N=31).
English: They are marked with 20 on one side and Pfizer on the other side.
Maltese: Huma mmarkati bin-numru 20 fuq naħa u Pfizer fuq in-naħa loħra.
English: − Paediatric: Pharmacokinetic data in the paediatric population are not available.
Maltese: Mhix disponibbli informazzjoni farmakokinetika dwar il-popolazzjoni pedjatrika.
English: They are marked with 40 on one side and Pfizer on the other side.
Maltese: Huma mmarkati bin-numru 40 fuq naħa u Pfizer fuq in-naħa loħra.
English: Each tablet contains 20 mg of atorvastatin as atorvastatin calcium trihydrate.
Maltese: Kull pillola fiha 20 mg ta' atorvastatin bħala atorvastatin calcium trihydrate.
English: They are marked with 10 on one side and Pfizer on the other side.
Maltese: Huma mmarkati bin-numru 10 fuq naħa u Pfizer fuq in-naħa loħra.
English: Each tablet contains 10 mg of atorvastatin as atorvastatin calcium trihydrate.
Maltese: Kull pillola fiha 10 mg ta' atorvastatin bħala atorvastatin calcium trihydrate.
English: Each tablet contains 40 mg of atorvastatin as atorvastatin calcium trihydrate.
Maltese: Kull pillola fiha 40 mg ta' atorvastatin bħala atorvastatin calcium trihydrate.
English: White to off-white, round chewable tablets with pink to purple specks debossed "20" on one side and "Pfizer" on the other measuring 8.7 mm in diameter.
Maltese: Pilloli tondi li tomgħodhom, bojod għal offwajt u b'tikek roża għal vjola, imnaqqxa bin-numru “20” fuq naħa u l-kelma “Pfizer” fuq in-naħa l-oħra, b'dijametru ta' 8.7 mm.
English: In a double-blind, placebo controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (FH) or severe hypercholesterolaemia were randomised to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks.
Maltese: Fi studju double-blind, ikkontrollat bil-plaċebo, segwit minn fażi open-label, 187 tifel u tifla postmenarkali ta' bejn 10-17-il sena (età medja 14.1-il sena) b'iperkolesterolemija eterożigota familjali (FH) jew iperkolesterolemija severa ġew randomizzati għal atorvastatin (n=140) jew plaċebo (n=47) għal 26 ġimgħa u mbagħad kollha ngħataw atorvastatin għal 26 ġimgħa.
English: An 8-week, open-label study to evaluate pharmacokinetics, pharmacodynamics, and safety and tolerability of atorvastatin was conducted in children and adolescents with genetically confirmed heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L.
Maltese: Sar studju open-label ta' 8 ġimgħat fuq tfal u adoloxxenti b'iperkolesterolemija eterożigota familjali ġenetikament ikkonfermata u LDL-C fil-linja bażi ta' ≥4 mmol/L biex jiġu evalwati lfarmakokinetika, il-farmakodinamika, u s-sigurtà u t-tollerabilità ta' atorvastatin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 20 mg atorvastatin (as calcium salt trihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda (1) li tomgħodha fiha 20 mg atorvastatin (bħala calcium salt trihydrate).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 40 mg atorvastatin (as calcium salt trihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda (1) li tomgħodha fiha 40 mg atorvastatin (bħala calcium salt trihydrate).
English: The blisters consist of a forming foil made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl /acryl heat-seal coating.
Maltese: Il-folji jikkonsistu minn folja tal-iffurmar magħmula mill-polyamide/folja talaluminju/polyvinyl chloride u dahar magħmul minn folja tal-aluminju/vinyl/kisja tal-acryl issiġillat bis-sħana.
English: White to off-white, round chewable tablets with pink to purple specks, debossed "10" on one side and “Pfizer” on the other measuring 7.1 mm in diameter.
Maltese: Pilloli tondi li tomgħodhom, bojod għal offwajt u b'tikek roża għal vjola, imnaqqxa bin-numru “10” fuq naħa u l-kelma “Pfizer” fuq in-naħa l-oħra, b'dijametru ta' 7.1 mm.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 10 mg atorvastatin (as calcium salt trihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda (1) li tomgħodha fiha 10 mg atorvastatin (bħala calcium salt trihydrate).
English: Blister packs containing 30 chewable tablets.
Maltese: Il-pakketti ta' folji fihom 30 pillola li tomgħodha.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 20 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Maltese: Kull pillola li tomgħodha fiha 20 mg atorvastatin (bħala atorvastatin calcium (trihydrate)).
English: At Week 8, on average, the percent change from baseline in LDL-C and TC was approximately 40% and 30%, respectively, over the range of exposures.
Maltese: F'Ġimgħa 8, bħala medja, il-bidla perċentwali mil-linja bażi fl-LDL-C u t-TC kienet madwar 40% u 30%, rispettivament, tul il-medda tal-esponimenti.
English: Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg, is limited.
Maltese: L-informazzjoni dwar is-sikurezza għal pazjenti pedjatriċi ttrattati b'dożi ogħla minn 20 mg, li jikkorrispondu għal madwar 0.5 mg/kg, hija limitata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 40 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Maltese: Kull pillola li tomgħodha fiha 40 mg atorvastatin (bħala atorvastatin calcium (trihydrate)).
English: White to off-white, round chewable tablets with pink to purple specks, debossed "40" on one side and "Pfizer" on the other measuring 10.3 mm in diameter.
Maltese: Pilloli tondi li tomgħodhom, bojod għal offwajt u b'tikek roża għal vjola, imnaqqxa bin-numru “40” fuq naħa u l-kelma “Pfizer” fuq in-naħa l-oħra, b'dijametru ta' 10.3 mm.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Maltese: Kull pillola li tomgħodha fiha 10 mg atorvastatin (bħala atorvastatin calcium (trihydrate)).
English: The dose may be increased to 80 mg daily, according to the response and tolerability.
Maltese: Id-doża tista' tiżdied għal 80 mg kuljum, skont ir-rispons u t-tollerabbilità.
English: • Restart the cycle of PSUR submission for Sortis and associated names as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Maltese: • Għandu jiġi pprovdut Pjan tal-Immaniġjar tar-Riskju (jew aġġornament tiegħu) għal-Sortis u għall-ismijiet assoċjati miegħu, li jikkunsidra wkoll l-informazzjoni ġdida fit-tfal u rrakkomandazzjonijiet tal-CHMP.
English: {PRODUCT NAME} 20 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT} 20 mg pilloli li tomgħodhom Atorvastatin calcium [Ara Anness I - {Biex timtela mill-pajjiż partikolari}]
English: Angioedema#
Maltese: Anġjoedima#
English: Manufacturer Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy
Maltese: Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), L-Italja