FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute between-group difference in the mean change in FEV1 during the treatment period was 152 mL, or approximately 11% of the mean FEV1 at enrollment.
Maltese: Id-differenza assoluta bejn il-gruppi fil-bida medja fil-FEV1 waqt il-perjodu tal-kura kienet 152 mL, jew madwar 11% tal-FEV1 medju mar-reġistrazzjoni.
English: Prophylaxis of organ rejection
Maltese: Profilassi ta' rifjut tal-organi
English: Kidney damage with low blood cell counts (thrombocytopaenic purpura/haemolytic uraemic syndrome)
Maltese: Ħsara fil-kliewi b'għadd baxx ta' ċelluli tad-demm (purpura tromboċitopenika/sindrome uremiku emolitiku)
English: Do not pass it on to others.
Maltese: L-aktar sintomu komuni ta' S-LAM huwa qtugħ ta' nifs.
English: Undesirable effects observed with patients with S-LAM
Maltese: Effetti mhux mixtieqa osservati f'pazjenti b'S-LAM
English: Cases of interstitial lung disease (including pneumonitis and infrequently bronchiolitis obliterans organising pneumonia (BOOP) and pulmonary fibrosis), some fatal, with no identified infectious aetiology have occurred in patients receiving immunosuppressive regimens including Rapamune.
Maltese: Każijiet ta' mard interstizjali tal-pulmun (li jinkludu pnewmonja u infrekwentement bronchitis obliterans organizing pneumonia (BOOP) u fibrożi pulmunarja), xi wħud minnhom fatali, bl-ebda etjoloġija infettiva identifikata, seħħew f'pazjenti li qegħdin jingħataw korsijiet immunosoppressivi li jinkludu Rapamune.
English: Stomach pain, diarrhoea, constipation, nausea
Maltese: Uġigħ fl-istonku, dijarea, stitikezza, nawsja
English: Each pack contains: one bottle (amber glass) containing 60 mL of Rapamune solution, one syringe adapter, 30 dosing syringes (amber plastic) and one syringe carry case.
Maltese: Kull pakkett fih: flixkun wieħed (ħġieġ ta' lewn safrani) li fih 60 mL ta' soluzzjoni ta' Rapamune, adapter wieħed għas-siringa, 30 siringa għad-dożaġġ (plastik ta' lewn safrani) u kaxxa tal-ġarr għal siringa waħda.
English: It is important to follow the instructions to drink Rapamune oral solution at once when a plastic container is used for the dilution and/or administration (see section 6.6).
Maltese: Huwa importanti li wieħed isegwi listruzzjonijiet sabiex tixrob Rapamune soluzzjoni orali minnufih meta l-kontenitur tal-plastik jintuża għad-dilwizzjoni u/jew għoti (ara sezzjoni 6.6).
English: In a study evaluating conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients, increased urinary protein excretion was commonly observed at 6 to 24 months after conversion to Rapamune (see section 5.1).
Maltese: Fi studju li evalwa l-bdil minn inibituri ta' calcineurin għal Rapamune f'pazjenti li kellhom trapjant tal-kliewi u li kienu fuq terapija ta' manteniment, żieda fit-tneħħija ta' proteini mal-awrina kienet osservata b'mod komuni wara minn 6 sa 24 xahar mill-bidla għal Rapamune (ara sezzjoni 5.1).
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA10.
Maltese: Il-qalba tal-pillola: lactose monohydrate, macrogol, magnesium stearate, talc.
English: Patients treated with ciclosporin and Rapamune beyond 3 months had higher serum creatinine levels and lower calculated glomerular filtration rates compared to patients treated with ciclosporin and placebo or azathioprine controls.
Maltese: Pazjenti kkurati b'ciclosporin u Rapamune għal aktar minn 3 xhur, kellhom livelli ogħla ta' krejatinina fis-serum u rati kkalkulati ta' filtrazzjoni glomerulari iktar baxxi meta mqabbla ma' pazjenti kkurati b'ciclosporin u plaċebo jew kontrolli b'azathioprine.
English: SPECIAL STORAGE CONDITIONS Do not store above 25˚C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25˚C.
English: Each pack contains: one bottle (amber glass) containing 60 mL of Rapamune solution, one syringe adapter, 30 dosing syringes (amber polypropylene) and one syringe carry case.
Maltese: Kull pakkett fih: flixkun wieħed (ħġieġ ta' lewn safrani) li fih 60 mL ta' soluzzjoni ta' Rapamune, adapter wieħed għas-siringa, 30 siringa għad-dożaġġ (polypropylene ta' lewn safrani) u carry case għal siringa waħda.
English: When taken with medicines called calcineurin inhibitors (ciclosporin or tacrolimus), Rapamune may increase the risk of kidney damage with low blood platelets and low red blood cell counts, with or without rash (thrombocytopaenic purpura/haemolytic uraemic syndrome).
Maltese: Meta jittieħed ma' mediċini msejħa inibituri ta' calcineurin (ciclosporin jew tacrolimus), Rapamune jista' jżid ir-riskju ta' ħsara fil-kliewi b'għadd baxx ta' plejlits fid-demm u għadd baxx ta' ċelluli taddemm ħomor, b'raxx jew mingħajru (purpura tromboċitopenika/sindrome uremiku emolitiku).
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni:jista' jaffettwa sa persuna 1 minn kull 100
English: 100 iu/ml Suspension for
Maltese: Mixtard 30 FlexPen 100 IU/ml
English: The mutual recognition procedure (UK/V/0355/001/MR) started on 26 November 2009.
Maltese: Il-proċedura ta' rikonoxximent reċiproku (UK/V/0355/001/MR) inbdiet fis-26 ta' Novembru 2009.
English: 5 August 2011
Maltese: 5 ta' Awwissu 2011
English: International non-proprietary name (inn): amoxicillin, clavulanic acid and prednisolone
Maltese: Denominazzjoni Komuni Internazzjonali (inn): amoxicillin, clavulanic acid u prednisolone
English: Oral explanations were given on 12 January 2011.
Maltese: Ingħataw spjegazzjonijiet orali fit-12 ta' Jannar 2011.
English: Written explanations were provided by the marketing authorisation holder on 13 September 2011 and 10 March 2011.
Maltese: Kienu pprovduti spjegazzjonijiet bil-miktub mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fit-13 ta' Settembru 2011 u fl-10 ta' Marzu 2011.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the co-rapporteurship.
Maltese: Wara r-riżenja tas-Sinjura Ruth Kearsley minn membru tas-CVMP, is-Sinjura Helen Jukes inħatret minflokha u ħadet ix-xogħol ta' korelatur.
English: Nine CVMP members expressed divergent positions, which are appended to the opinion.
Maltese: Disa' membri tas-CVMP esprimew pożizzjonijiet diverġenti, li huma annessi għall-opinjoni.
English: Nisamox Lactating Cow Intramammary Suspension (Nisamox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Maltese: Nisamox Sospensjoni Intramammarja għal Baqar li Jreddgħu (Nisamox) hija sospensjoni intramammarja li fiha amoxicillin, clavulanic acid u prednisolone.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Nisamox via a mutual recognition procedure in the Netherlands on the basis of the marketing authorisation granted by the United Kingdom.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Norbrook laboratories Ltd, issottometta applikazzjoni għal Nisamox permezz ta' proċedura ta' rikonoxximent reċiproku fil-Pajjiżi l-Baxxi abbażi tal-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mir-Renju Unit.
English: The application was submitted as a generic of the reference product, Synulox Lactating Cow Intramammary Suspension marketed by Pfizer Ltd.
Maltese: L-applikazzjoni kienet sottomessa bħala ġenerika tal-prodott ta' referenza, Synulox Sospensjoni Intramammarja għal Baqar li Jreddgħu mqiegħda fis-suq minn Pfizer Ltd.
English: The Committee appointed Mr Johan Schefferlie as rapporteur and Mrs Ruth Kearsley as co-rapporteur.
Maltese: Il-Kumitat ħatar lis-Sur Johan Schefferlie bħala relatur u lis-Sinjura Ruth Kearsley bħala korelatur.
English: The referral procedure started on 14 July 2010.
Maltese: Il-proċedura ta' riferiment inbdiet fl-14 ta' Lulju 2010.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, the Netherlands, that the safety and efficacy of the product had not been sufficiently demonstrated.
Maltese: Fit-2 ta' Lulju 2010, ir-Renju Unit, bħala l-Istat Membru ta' Referenza, irrefera l-kwistjoni lill-Aġenzija Ewropea għall-Mediċini skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, minħabba tħassib imqajjem mill-Istat Membru Kkonċernat, il-Pajjiżi l-Baxxi, li s-sigurtà u l-effikaċja tal-prodott ma kinux intwerew b'mod suffiċjenti.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Nisamox Lactating Cow Intramammary Suspension is
Maltese: Abbażi tal-evalwazzjoni tal-valutazzjoni tar-relatur tad-dejta disponibbli attwalment, is-CVMP ikkunsidra li l-profil tal-benefiċċju/riskju ta' Nisamox Sospensjoni Intramammarja għal Baqar li Jreddgħu huwa negattiv, u għaldaqstant adotta opinjoni fis-6 ta' April 2011 li tirrakkomanda r-rifjut tal-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq u s-sospensjoni tal-awtorizzazzjoni għat-tqedgħid fissuq eżistenti.
English: The final opinion was converted into a Decision by the European Commission on 5 August 2011.
Maltese: L-opinjoni finali kienet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fil-5 ta' Awwissu 2011.
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel
Maltese: Westlaan 142 2909 LD Capelle a/d IJssel
English: Invented name Name
Maltese: Isem inventat Isem
English: Pharma Gyógyszerkereskedel mi Kft.
Maltese: C.P. Pharma Gyógyszerkereskedel mi Kft.
English: de Europa 20B Parque Empresarial la Moraleja
Maltese: Avda. de Europa 20B Parque Empresarial la Moraleja
English: Contains a source of phenylalanine.
Maltese: Fih sors ta' phenylalanine.
English: Via Livornese, 897La Vettola 56010 Pisa - Italy
Maltese: Via Livornese, 897La Vettola 56010
English: Pfizer Polska Sp.z o.o.
Maltese: Pfizer Polska Sp.z o.o. ul.
English: Czech Republic Pfizer, spol.
Maltese: Repubblika Ċeka Pfizer, spol.
English: Slovak Republic Pfizer Europe MA EEIG, Ramsgate
Maltese: Repubblika Slovakka Pfizer Europe MA EEIG, Ramsgate
English: Each {PRODUCT NAME} 5 mg chewable tablet contains 0.625 mg aspartame.
Maltese: TAL-PRODOTT} 5 mg pillola li tomgħodha fiha 0.625 mg aspartame.
English: {PRODUCT NAME} tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregelificatum, mannitol, aspartame, sucralose, grape flavour and magnesium stearate.
Maltese: TAL-PRODOTT} fihom ukoll is-sustanzi mhux attivi: calcium carbonate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregelificatum, mannitol, aspartame, sucralose, togħma tal-għeneb u magnesium stearate.
English: Hypercholesterolaemia:
Maltese: Iperkolesterolemija:
English: Pfizer KFT, 1123 Budapest, Alkotás u. 53.
Maltese: Pfizer KFT, 1123 Budapest, Alkotás u. 53. MOM Park "F" Ép., Hungary
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 26week double-blind phase.
Maltese: Il-valur medju miksub ta' LDL-C kien 3.38 mmol/l (medda: 1.81-6.26 mmol/l) filgrupp ta' atorvastatin meta mqabbel ma' 5.91 mmol/l (medda: 3.93-9.96 mmol/l) fil-grupp talplaċebo matul il-fażi double-blind ta' 26 ġimgħa.
English: Pfizer Pharma GmbH, Linkstraße 10 10785 Berlin, Germany
Maltese: GmbH, Linkstraße 10 10785
English: [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Biex timtela mill-pajjiż partikolari] {Isem u Indirizz} <{tel}> <{fax}> <{e-mail}>
English: This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
Maltese: Din il-mediċina tiġi bħala pilloli li tomgħodhom ta' 5 mg, 10 mg, 20 mg u 40 mg u pilloli miksijin b'rita ta' 10 mg, 20 mg, 40 mg u 80 mg.
English: Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
Maltese: Kien osservat tnaqqis konsistenti fil-LDL-C u t-TC fuq il-medda tal-esponimenti għal atorvastatin u o-hydroxyatorvastatin.
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: Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg
Maltese: Pfizer Lussemburgu SARL, 51, Avenue J. F.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 5 mg atorvastatin (as calcium salt trihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda (1) li tomgħodha fiha 5 mg atorvastatin (bħala calcium salt trihydrate).
English: Cohort A included 15 children, 6 to 12 years of age and at Tanner Stage 1.
Maltese: Grupp A kien jikkonsisti minn 15-il tifel u tifla, minn 6 sa 15-il sena u f'Tanner Stage 1.
English: Atorvastatin significantly decreased plasma levels of totalC, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Maltese: Atorvastatin naqqas b'mod sinifikanti llivelli ta' C-totali, trigliċeridi, u apolipoproteina B fil-plażma matul il-fażi double-blind ta' 26 ġimgħa.
English: Pfizer Corporation Austria Ges.m.b.H.
Maltese: Pfizer Corporation Austria Ges.m.b.H. Floridsdorfer Hauptstraße 1
English: Each tablet contains 5 mg of atorvastatin as atorvastatin calcium trihydrate.
Maltese: Kull pillola fiha 5 mg ta' atorvastatin bħala atorvastatin calcium trihydrate.
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 filmcoated atorvastatin tablets once daily, respectively.
Maltese: Fi studju open-label ta' 8 ġimgħat, pazjenti pedjatriċi Tanner Stage 1 (N=15) u Tanner Stage 2 (N=24) (etajiet minn 6-17-il sena) b'iperkolesterolemija eterożigota familjali u LDL-C fil-linja 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: Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 6-17 years old
Maltese: Iperkolesterolemija Eterożigota Familjali fit-tfal minn 6 sa 17-il sena
English: Common: Headache
Maltese: Komuni: Uġigħ ta' żaqq
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 fl-LDL-C f'ġimgħa 26 (p<0.05) meta mqabbel ma' colestipol (N=31).
English: Developmental safety in the paediatric population has not been established (see section 4.8).
Maltese: Is-sigurtà għall-iżvilupp fit-tfal ma ġietx stabbilita (ara sezzjoni 4.8).
English: The study lasted 3 years: LDL-cholesterol was lowered by 36%.
Maltese: Il-kolesterol LDL tbaxxa b'36%.
English: Hypercholesterolaemia {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Maltese: TAL-PRODOTT} huwa indikat bħala żieda mad-dieta għat-tnaqqis tal-kolesterol totali għoli, il-kolesterol LDL, l-apolipoproteina B, u t-trigliċeridi f'pazjenti adulti, adoloxxenti u tfal ta' 10 snin jew aktar b'iperkolesterolemija primarja fosthom iperkolesterolemija familjali (varjant eterożigota) jew iperlipidemija kombinata (imħallta) (li jikkorrispondu għat-Tipi IIa u IIb tal-klassifikazzjoni ta' Fredrickson) meta r-rispons għad-dieta u miżuri oħra mhux farmakoloġiċi ma jkunx adegwat.
English: Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 10-17 years old
Maltese: Iperkolesterolemija Eterożigota Familjali f'Pazjenti Pedjatriċi minn 10 sa 17-il sena
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Maltese: FARMAĊEWTIKA U KONTENUT 30 pillola li tomgħodha
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' 10-17-il sena (età medja 14.1-il sena) b'iperkolesterolemija eterożigota familjali (FL) jew iperkolesterolemija severa ġew randomizzati għal atorvastatin (n=140) jew plaċebo (n=47) għal 26 ġimgħa u mbagħad kollha kemm huma ngħataw atorvastatin għal 26 ġimgħa.
English: A total of 39 children and adolescents, 6 to 17 years of age, were enrolled.
Maltese: B'kollox ħadu sehem 39 tifel u tifla u adoloxxenti, ta' bejn 6 u 17-il sena.
English: Paediatric: Pharmacokinetic data in the paediatric population are not available.
Maltese: Mhix disponibbli informazzjoni farmakokinetika dwar il-popolazzjoni pedjatrika.
English: The active substance of {PRODUCT NAME} is atorvastatin.
Maltese: Is-sustanza attiva ta' {ISEM
English: The European Medicines Agency has waived the obligation to submit the results of studies with atorvastatin in children aged 0 to less than 6 years in the treatment of heterozygous hypercholesterolaemia and in children aged 0 to less than 18 years in the treatment of homozygous familial hypercholesterolaemia, combined (mixed) hypercholesterolaemia, primary hypercholesterolaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea dwar il-Mediċini rrinunzjat l-obbligu li jiġu sottomessi r-riżultati ta' studji b'atorvastatin fi tfal minn 0 sa inqas minn 6 snin fil-kura ta' iperkolesterolemija eterożigota u fi tfal minn 0 sa taħt 18-il sena fil-kura ta' iperkolesterolemija omożigota familjali, iperkolesterolemija kombinata (mħallta), iperkolesterolemija primarja u fil-prevenzjoni ta' episodji kardjovaskulari (ara sezzjoni 4.2 għal informazzjoni dwar l-użu fit-tfal).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 5 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Maltese: Kull pillola li tomgħodha fiha 5 mg atorvastatin (bħala atorvastatin calcium (trihydrate)).
English: There is limited experience in children between 6-10 years of age (see section 5.1).
Maltese: Teżisti esperjenza limitata fi tfal ta' bejn 6-10 snin (ara sezzjoni 5.1).
English: Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Maltese: L-esperjenza fil-pedjatrija hija limitata għal numru żgħir ta' pazjenti (età 4 - 17-il sena) b' dislipidemiji severi, bħal iperkolesterolemija omożigota familjali.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattożju, defiċjenza ta' Lapp lactose jew assorbiment ħażin tal-glukożju-galattożju m'għandhomx jieħdu din il-mediċina.
English: Mean values for LDL-C, TC, VLDL-C, and Apo B decreased by Week 2 among all subjects.
Maltese: Il-valuri medji għal LDL-C, TC, VLDL-C, u Apo B sa Ġimgħa 2 kienu naqsu fost l-individwi kollha.
English: A compassionate use study in patients with severe hypercholesterolaemia (including homozygous hypercholesterolaemia) included 46 paediatric patients treated with atorvastatin titrated according to response (some subjects received 80 mg atorvastatin per day).
Maltese: Studju ta' użu b'kompassjoni f'pazjenti b'iperkolesterolemija severa (iperkolesterolemija omożigota) inkluda 46 pazjenti tfal ttrattati b'atorvastatin titrat skont ir-rispons (xi individwi ngħataw 80 mg ta' atorvastatin fil-ġurnata).
English: White to off-white, round chewable tablets with pink to purple specks, debossed "5" on one side and “Pfizer” on the other measuring 5.6 mm in diameter.
Maltese: Pilloli tondi li tomgħodhom, bojod għal offwajt u b'tikek roża għal vjola, imnaqqxa bin-numru “5” fuq naħa u l-kelma “Pfizer” fuq in-naħa l-oħra, b'dijametru ta' 5.6 mm.
English: Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors.
Maltese: Prevenzjoni ta' episodji kardjovaskulari f'pazjenti adulti stmati li huma f'riskju għoli għall-ewwel episodju kardjovaskulari (ara Sezzjoni 5.1), bħala żieda mal-korrezzjoni ta' fatturi oħra ta' riskju.
English: The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Maltese: Id-dejtabejż dwar is-sigurtà klinika tinkludi informazzjoni dwar is-sigurtà għal 249 pazjenti tfal li ngħataw atorvastatin, li 7 pazjenti minnhom kellhom inqas minn 6 snin, 14-il pazjent kellhom bejn 6 u 9 snin, u 228 pazjent kellhom bejn 10 u 17-il sena.
English: They are marked with 5 on one side and Pfizer on the other side.
Maltese: Huma mmarkati bin-numru 5 fuq naħa u Pfizer fuq in-naħa l-oħra.
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: 4.3 Contraindications {To be completed nationally}.
Maltese: 4.3 Kontra-indikazzjonijiet {Biex timtela mill-pajjiż partikolari}.
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-sigurta` fi tfal ikkurati b'dożi ogħla minn 20 mg, li jikkorrispondu għal madwar 0.5 mg/kg, hija limitata.
English: Apparent oral clearance of atorvastatin in paediatric subjects appeared similar to adults when scaled allometrically by body weight.
Maltese: It-tneħħija orali apparenti ta' atorvastatin f'individwi pedjatriċi dehret simili għall-adulti meta skalata b'mod allometriku skont il-piż tal-ġisem.
English: Avda.
Maltese: Awstrija
English: The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and up-titrated to 20 mg if the LDL-C level was >3.36 mmol/l.
Maltese: Id-doża ta' atorvastatin (darba kuljum) kienet 10 mg għall-ewwel 4 ġimgħat u miżjuda għal 20 mg jekk il-livell ta' LDL-C kien >3.36 mmol/l.
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: Grape flavour
Maltese: TAGĦRIF
English: See package leaflet for further information.
Maltese: Ara l-fuljett ta' tagħrif għal aktar informazzjoni.
English: 6.2 Incompatibilities {To be completed nationally}.
Maltese: .2 Inkompatibilitajiet {Biex timtela mill-pajjiż partikolari}.