FrancophonIA/ELRC3.0 huggingface dataset:
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Maltese: Jekk issir dijanjosi ta' tuberkulożi mhux attiva (‘moħbija') terapija kontra t-tuberkulożi għandha tinbeda b'terapija kontra t-tuberkulożi qabel ma jinbeda infliximab, u skont ir-rakkomandazzjonijiet lokali.
English: The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
Maltese: Il-kombinazzjoni ta' infliximab ma' sustanzi bijoloġiċi terapewtiċi oħrajn li jintużaw biex jikkuraw listess kundizzjonijiet bħal infliximab, inkluż anakinra u abatacept, mhix irrakkomandata (ara sezzjoni 4.4).
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Maltese: • Sinjali ta' problemi tal-fwied (inkluża infezzjoni tal-epatite B meta tkun qabditek epatite B fil-passat) bħal meta l-ġilda jew għajnejk jisfaru, l-awrina jkollha lewn kannella-skur, uġigħ jew nefħa fil-parti leminija ta' fuq tal-istonku, uġigħ fil-ġogi, raxx fil-ġilda, jew deni.
English: (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD c)
Maltese: Punteġġ totali d (punteġġ van der Heijde Sharp) Bdil mil-linja bażi (Medja ± SD
English: In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with infliximab at doses similar to those used in rheumatoid arthritis and Crohn's disease.
Maltese: Fi studju kliniku esploratorju li kien jinvolvi pazjenti b'COPD moderat sa sever li kienu jew ipejpu fil-preżent jew kienu jpejpu fil-passat, 157 pazjent adult kienu kkurati b'infliximab b'dożi simili għal dawk użati f'artrite rewmatojde u l-marda ta' Crohn. Disgħa minn dawn il-pazjenti żviluppaw tumuri malinni, inkluża limfoma.
English: • If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Maltese: • Jekk tesperjenza riattivazzjoni tal-epatite B, it-tabib tiegħek jista' jkollu bżonn iwaqqaf il-kura tiegħek u jista' jagħtik mediċini bħal terapija antivirali effettiva b'kura ta' sostenn.
English: • Stroke
Maltese: Flimkien
English: Cyanosis, pericardial effusion.
Maltese: Ċijanożi, effużjoni mill-perikardju.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Maltese: TNF alfa hija involuta fil-proċessi infjammatorji tal-ġisem għalhekk meta tkun imblukkata tista' tonqos l-infjammazzjoni f'ġismek.
English: Whereas
Maltese: {ISEM
English: The temporary suspension of atorvastatin during fusidic acid therapy has been included in line with the Type II MRP variation (DE/H/0109/001- 004/II/094).
Maltese: Is-sospensjoni temporanja ta' atorvastatin matul terapija ta' fusidic acid ġiet inkluża b'mod konformi mal-varjazzjoni tal-MRP Tip II (DE/H/0109/001- 004/II/094).
English: The indication proposed by the MAH for the prevention of cardiovascular disease is in line with the wording agreed upon by the CHMP on 20-23 March 2006 (CHMP/76062/2006) during the Article 6(12) referral.
Maltese: L-indikazzjoni proposta mill-MAH għall-prevenzjoni ta' mard kardjovaskulari hija konformi malformolazzjoni li kien sar qbil fuqha mis-CHMP fl-20-23 ta' Marzu 2006 (CHMP/76062/2006) waqt irreferenza skont l-Artikolu 6(12).
English: Only limited data are available (see section 5.1).
Maltese: Hija disponibbli biss dejta limitata (ara sezzjoni 5.1).
English: Data were reviewed for all doses combined (10-80mg) vs placebo, and adverse events were grouped by categories of organ systems.
Maltese: Id-dejta ġiet riveduta għad-dożi kollha kkombinati (10-80mg) vs plaċebo, u l-episodji avversi ġew raggruppati skont il-kategoriji tas-sistemi ta' klassifika tal-organi.
English: The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily (see section 5.1).
Maltese: Id-doża ta' atorvastatin f'pazjenti b'iperkolesterolemija familjali omożigotika hija ta' 10 sa 80 mg kuljum (ara sezzjoni 5.1).
English: ‘Hypercholesterolaemia ‘{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol (totalC), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in patients 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: IL-PRODOTT} huwa indikat bħala addizzjoni għad-dieta għat-tnaqqis ta' total elevat ta' kolesterol (total-C), LDL-kolesterol (LDL-C), apolipoprotein B, u trigliċeridi f'pazjenti b'iperkolesterolemija primarja inkluża iperkolesterolemija familjali (varjant eterożigotiku) jew iperlipidemija kkombinata (imħallta) (li tikkorrispondi għat-Tipi IIa u IIb tal-klassifikazzjoni Fredrickson) meta r-rispons għad-dieta u miżuri mhux farmakoloġiċi ma jkunux tajbin biżżejjed.
English: The information that rare reports of congenital anomalies have been received following exposure to HMG-CoA reductase inhibitors has been included.
Maltese: Ġiet inkluża informazzjoni li waslu rapporti rari ta' anomaliji konġenitali wara espożizzjoni għal inibituri ta' HMG-CoA reductase.
English: Summaries of the studies investigating the effect of atorvastatin on Atherosclerosis (REVERSAL study), Acute Coronary Syndrome (MIRACL trial), the Prevention of Cardiovascular Disease (ASCOT-LLA and CARDS trials), Recurrent Stroke (SPARCL study) were included.
Maltese: Ġew inklużi sommarji tal-istudji li jinvesigaw l-effett ta' atorvastatin fuq Aterosklerożi (studju REVERSAL), Sindromu Koronarju Akut (prova MIRACL), il-Prevenzjoni tal-Mard Kardjovaskulari (provi ASCOT-LLA u CARDS trials), Puplesija Rikorrenti (studju SPARCL).
English: The MAH conducted a review of the pooled data from the 17 completed placebo-controlled clinical trials in the atorvastatin clinical trial database as of June 24, 2008, when the review was initiated.
Maltese: Il-MAH wettaq reviżjoni tad-dejta miġbura mis-17-il prova klinika kkontrollata bi plaċebo mwettqa fiddatabase tal-prova klinika ta' atorvastatin mill-24 ta' Ġunju 2008, meta nbdiet ir-reviżjoni.
English: Homozygous familial hypercholesterolaemia
Maltese: Iperkolesterolemija familjali omożigotika
English: The pooled dataset included a total of 16,066 patients, treated for a median period of 53 weeks.
Maltese: Is-sett ta' dejta miġbur inkluda total ta' 16,066 pazjent ikkurati għal perjodu medjan ta' 53 ġimgħa.
English: Pharmacokinetic data in the paediatric population are not available.
Maltese: Tagħrif farmakokinetiku fil-popolazzjoni pedjatrika mhuwiex disponibbli.
English: Hepatic impairment {PRODUCT NAME} should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
Maltese: IL-PRODOTT} għandu jintuża b'kawtela f'pazjenti b'indeboliment epatiku (ara sezzjonijiet 4.4 u 5.2).
English: The four cut-off ranges as proposed by the MAH take into account the dose proportional increase in AUC exposure over the 1080 mg atorvastatin dose range and the available strengths (10, 20, 40, and 80 mg) of atorvastatin tablets.
Maltese: L-erba' meded cutoff kif proposti mill-MAH iqisu ż-żieda proporzjonali tad-doża f'espożizzjonijiet tal-AUC fuq il-medda tad-doża ta' 10-80 mg atorvastatin u l-qawwiet disponibbli (10, 20, 40, u 80 mg) ta' pilloli ta' atorvastatin.
English: Hence, the MAH has not included this wording in the proposed harmonised SmPC.
Maltese: Għaldaqstant, il-MAH ma nkludiex din il-formolazzjoni fl-SmPC armonizzat propost.
English: The CHMP agreed with the MAH's proposal.
Maltese: Is-CHMP qabel mal-proposta tal-MAH.
English: Heterozygous familial hypercholesterolaemia
Maltese: Iperkolesterolemija familjali eterożigotika
English: The adverse events in the database were all mapped to MedDRA dictionary terms.
Maltese: Lepisodji avversi fid-database tqabblu mat-termini tad-dizzjunarju tal-MedDRA.
English: • Efficacy and safety issues
Maltese: • Kwistjonijiet ta' effikaċja u sigurtà
English: The following wording was agreed by the CHMP:
Maltese: Il-formolazzjoni li ġejja sar qbil fuqha mis-CHMP:
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 irripons u t-tollerabilità.
English: Section 4.4 - Special warnings and precautions for use The list of clinically relevant CYP3A4-inhibitors or transporter inhibitors has been made more general including inhibitors for which there is no interaction data available but where significant interaction could be assumed, since an increased risk can be expected for all potent CYP3A4 or OATP1B1 inhibitors.
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Il-lista ta' inibituri ta' CYP3A4 klinikament relevanti jew inibituri trasportaturi ġiet magħmula iktar ġenerali li tinkludi inibituri li għalihom ma hemm ebda dejta ta' interazzjoni disponibbli iżda fejn tista' tiġi presupposta interazzjoni sinifikanti, minħabba li jista' jkun mistenni riskju miżjud għall-inibituri CYP3A4 jew OATP1B1 qawwija kollha.
English: The MAH has used the MRP text as the harmonised SmPC including the proposed harmonised wording for special populations such as the elderly, paediatrics, gender differences, patients with renal and hepatic insufficiency and SLOC1B1 polymorphism (and its effects on atorvastatin exposure) have been included.
Maltese: Il-MAH uża t-test tal-MRP minħabba li ġie inkluż l-SmPC armonizzat inkluż il-formolazzjoni armonizzata proposta għal popolazzjoni speċjali bħall-anzjani, il-pedjatriċi, differenzi bejn is-sessi, pazjenti b'indeboliment tal-kliewi u tal-fwied u polimorfiżmu ta' SLOC1B1 (u l-effetti tiegħu fuq l-espożizzjoni ta' atorvastatin).
English: Experience in paediatrics 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 minħabba n-numru żgħir ta' pazjenti (età 4 - 17 sena) b' dyslipidemias serji, bħal iperkolesterolemija familjali omożigotika.
English: In the primary prevention trials the dose was 10 mg/day.
Maltese: Fil-provi ta' prevenzjoni primarja, id-doża kienet ta' 10 mg/jum.
English: - The MAH has followed the request by the CHMP to include a recommendation for caution for patients with hepatic impairment in section 4.2, with cross references to sections 4.4 and 5.2 of the harmonised SmPC.
Maltese: - Il-MAH mexa skont it-talba tas-CHMP li tiġi inkluża rakkomandazzjoni ta' twissija għal pazjenti b'indeboliment tal-fwied fis-sezzjoni 4.2, b'kontro-referenzi għas-sezzjonijiet 4.4 u 5.2 tal-SmPC armonizzat.
English: The harmonized text is identical to the current approved MRP SPC.
Maltese: It-test armonizzat huwa identiku għall-SPC tal-MRP approvat attwalment.
English: - The information derived from a compassionate use study in the homozygous familial hypercholesterolemia patient population has been moved to section 5.1 as suggested by the CHMP.
Maltese: - L-informazzjoni derivata minn studju b'użu kompassjonali fil-popolazzjoni tal-pazjenti b'iperkolesterolemija familjali omożigotika tressqat għal sezzjoni 5.1 kif issuġġerit mis-CHMP.
English: Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
Maltese: Wara dan, jew id-doża tkun tista' tiżdied għal massimu ta' 80 mg kuljum jew bile acid sequestrant jista' jiġi kkombinat ma' 40 mg atorvastatin darba kuljum.
English: The following wording was agreed by the CHMP: ‘Prevention of cardiovascular disease
Maltese: Il-formolazzjoni li ġejja sar qbil fuqha mis-CHMP: ‘Prevenzjoni ta' mard kardjovaskulari
English: Discontinuation due to adverse reactions occurred in 5.2% of patients on atorvastatin compared to 4.0% of the patients on placebo.
Maltese: It-twaqqif minħabba reazzjonijiet avversi seħħ f'5.2% tal-pazjenti li kienu fuq atorvastatin meta mqabbla ma' 4.0% tal-pazjenti li kienu fuq plaċebo.
English: Information on paediatric studies has not been included in this procedure as the Art 29 paediatric referral has no bearing on this Art 30 harmonisation referral.
Maltese: Informazzjoni dwar studji pedjatriċi ma ġietx inkluża f'din il-proċedura minħabba li rreferenza pedjatrika ta' Art. 29 ma għandha ebda effett fuq ir-referenza għall-armonizzazzjoni tal-Art 30.
English: - during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6).'
Maltese: - matul tqala, waqt it-treddigħ u f'nisa f'età li fiha jista' jkollhom it-tfal li ma jużawx miżuri kontraċettivi xierqa (ara Sezzjoni 4.6).'
English: The information in Section 4.5 (text and table formats) has been rearranged such that drug interactions are now grouped under either “Effect of co-administered drugs on atorvastatin” or “Effect of atorvastatin on co-administered drugs.” As requested by the CHMP, the MAH has included mechanistic information and extrapolations.
Maltese: L-informazzjoni fis-Sezzjoni 4.5 (test u formati tat-tabelli) ġiet irranġata mill-ġdid b'tali mod li linterazzjonijiet tal-mediċina issa huma raggruppati taħt jew “Effett ta' mediċini ko-amministrati fuq atorvastatin” jew l-“Effett ta' atorvastatin fuq mediċini ko-amministrati.”
English: In line with the SmPC guidance, dated September 2009, brief and qualitative statement covering the nonclinical safety profile of atorvastatin have been included.
Maltese: B'mod konformi mal-gwida tal-SmPC, datata Settembru 2009, ġiet inkluża dikjarazzjoni qasira u kwalitattiva li tkopri l-profil tas-sigurtà mhux kliniku ta' atorvastatin.
English: Prevention of cardiovascular events in 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' avvenimenti kardjovaskolari f'pazjenti stmati li għandhom riskju akbar għall-ewwel avveniment kardjovaskulari (ara sezzjoni 5.1), bħala aġġunt għall-korrezzjoni ta' fatturi ta' riskju oħrajn.'
English: As "insomnia" and "nightmares" have already been included in the SmPC and "memory loss" is found as "amnesia", additional terms were not considered to be necessary by the MAH, in order to fulfill the PhVWP Statin Class wording, and this proposal was accepted by the CHMP.
Maltese: Minħabba li "insomnija" u "ħmar il-lejl" diġà ġew inklużi fl-SmPC u t-"telf tal-memorja" jinstab bħala "amnesija", termini addizzjonali ma tqisux neċessarji mill-MAH, sabiex tiġi ssodisfata lformolazzjoni tal-kliem tal-Klassi ta' Statin tal-PhVWP, u l-proposta ġiet aċċettata mis-CHMP.
English: Following agreement of the Statin Class wording by the PhVWP in November 2009, the agreed text has been included.
Maltese: Wara qbil fuq il-formolazzjoni tal-Klassi ta' Statin mill-PhVWP f'Novembru 2009, it-test maqbul ġie nkluż.
English: The maximum dose is 80 mg once a day.
Maltese: Id-doża massima hija ta' 80 mg darba kuljum.
English: Variations to the drug product - atorvastatin calcium, small, round film-coated tablets - are comprehensively documented and the amendments proposed regarding the harmonisation are considered acceptable by the CHMP.
Maltese: Varjazzjonijiet għall-prodott mediċinali - atorvastatin calcium, pilloli żgħar, tondi, miksijin b'rita - huma ddokumentati b'mod komprensiv u l-emendi proposti fir-rigward tal-armonizzazzjoni tqiesu aċċettabbli mis-CHMP.
English: Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
Maltese: Id-dożi għandhom ikunu individwalizzati u aġġustati kull 4 ġimgħat sa 40 mg kuljum.
English: Myopathy has not been included in the list of contraindications since no contraindication regarding myopathy was agreed for previous Art 30 procedures for pravastatin, simvastatin and fluvastatin.
Maltese: Il-mijopatija ma ġietx inkluża fil-lista ta' kontraindikazzjonijiet minħabba li ebda kontraindikazzjoni firrigward tal-mijopatija ma ġiet inkluża għal proċeduri ta' Art. 30 preċedenti għal pravastatin, simvastatin u fluvastatin.
English: Lower starting doses of atorvastatin for potent CYP3A4 inhibitors and lower maximum doses of atorvastatin for both potent and moderate CYP3A4 inhibitors have been recommended as requested by the CHMP.
Maltese: Dożi tal-bidu iktar baxxi ta' atorvastatin għal inibituri CYP3A4 qawwijin u dożi massimi iktar baxxi ta' atorvastatin kemm għal inibituri CYP3A4 qawwijin u moderati ġiet rakkomandata kif mitlub mis-CHMP.
English: Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Maltese: Iperkolesterolemija primarja u iperlipidemija kkombinata (mħallta)
English: The MAH's proposal regarding hypercholesterolaemia indications were mostly supported except for the proposal to include the wording that: ‘Lipitor also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios'.
Maltese: Il-proposti tal-MAH fir-rigward tal-indikazzjonijiet għall-iperkolesterolemija kienu fil-maġġoranza tagħhom appoġġjati ħlief għall-proposta li jkun inkluż il-kliem li: ‘Lipitor jgħolli wkoll il-proporzjonijiet tal-HDL-kolesterol u jnaqqas l-LDL/HDL u kolesterol/HDL totali'.
English: The proposed SmPC changes were based on data from the Anglo-Scandinavian Cardiac Outcomes Trial - Lipid-Lowering Arm (ASCOT-LLA), and the Collaborative Atorvastatin Diabetes Study (CARDS).
Maltese: KardijaċiFergħa tat-Tnaqqis tal-Lipidi (ASCOT-LLA), u l-Istudju Kollaborattiv Atorvastin Dijabete (CARDS).
English: Section 4.6 - Pregnancy and lactation
Maltese: Sezzjoni 4.6 - Fertilità, tqala u treddigħ
English: The usual starting dose is 10 mg once a day.
Maltese: Id-doża tal-bidu normali hija ta' 10 mg darba kulljum.
English: {PRODUCT NAME} is contraindicated in patients with active liver disease (see section 4.3).
Maltese: IL-PRODOTT} huwa kontro-indikat f'pazjenti b'mard tal-fwied attiv (ara sezzjoni 4.3).
English: Information regarding Concomitant treatment with other medications has been included in section 4.5.
Maltese: Informazzjoni dwar kura konkomittanti ma' medikazzjonijiet oħrajn ġiet inkluża fis-sezzjoni 4.5.
English: - with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
Maltese: - b'mard tal-fwied attiv jew żidiet persistenti mhux spjegati ta' serum transaminases li jaqbżu 3 darbiet il-limitu ta' fuq tan-normal
English: For the indication relating to the prevention of cardiovascular disease, the dosing information is taken from the MRP SmPC.
Maltese: Għall-indikazzjoni relatata mal-prevenzjoni ta' mard kardjovaskulari, l-informazzjoni għad-dożaġġ hija meħuda mill-SmPC tal-MRP.
English: The main areas of disharmony which were addressed by the MAH related to the indication, posology, special warnings and precaution for use, interaction with other medicinal products, pregnancy and lactation, undesirable effects, pharmacodynamic properties, pharmacokinetic properties and preclinical safety data.
Maltese: L-oqsma prinċipali ta' nuqqas ta' armonija li ġew indirizzati mill-MAH kellhom x'jaqsmu malindikazzjoni, pożoloġija, twissijiet speċjali u prekawzjonijiet għall-użu, interazzjoni ma' prodotti mediċinali oħrajn, tqala u treddigħ, effetti mhux mixtieqa, tagħrif farmakodinamiku, tagħrif farmakokinetiku u tagħrif ta' qabel l-użu kliniku.
English: The remaining undesirable effects mentioned in the PhVWP Statin Class wording have also been included.
Maltese: Il-bqija tal-effetti mhux mixtieqa msemmija fil-formolazzjoni tal-kliem tal-Klassi ta' Statin ta' PhVWP ġew inklużi wkoll.
English: The MAH has provided satisfactory justification for the proposed atorvastatin dosing recommendations associated with the specific fold-increases of atorvastatin exposure during coadministration with the interacting drugs.
Maltese: Il-MAH ipprovda ġustifikazzjoni sodisfaċenti għar-rakkomandazzjonijiet ta' dożaġġ ta' atorvastatin proposti biż-żidiet speċifiċi ta' numru ta' drabi ta' espożizzjoni ta' atorvastatin waqt koamministrazzjoni mal-mediċini ta' interazzjoni.
English: - Paediatric information currently exists in the Member States, and this has been harmonised and included.
Maltese: - Fil-preżent, fl-Istati Membri teżisti informazzjoni pedjatrika, u din ġiet armonizzata u nkluża.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Lipitor and associated names (see Annex I).
Maltese: • is-sommarju tal-karatteristiċi tal-prodott, tikketta u fuljett ta' tagħrif proposti mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq ġew ivvalutati fuq il-bażi tad-dokumentazzjoni sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat is-CHMP irrakkomanda l-emenda tal-awtorizzazzjonijiet għat-tqegħid fis-suq li s-sommarju talkaratteristiċi tal-prodott, tikketta u fuljett ta' tagħrif huma stabbliti fl-Anness
English: - with hypersensitivity to the active substance or to any of the excipients of this medicinal product
Maltese: - b'sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza oħra ta' dan il-prodott mediċinali
English: The MAH has used the MRP SmPC text as the proposed harmonised SmPC text as the overdose wording across the Member State SmPCs is essentially identical to the current MRP SmPC text.
Maltese: Il-maġġoranza tas-swieq fil-preżent għandhom it-test armonizzat propost, li huwa konformi mal-linja gwida tal-SmPC datata Settembru 2009.
English: The following wording was agreed by the CHMP: ‘Posology
Maltese: Il-formolazzjoni li ġejja sar qbil fuqha mis-CHMP: ‘Pożoloġija
English: Regarding special populations:
Maltese: IL-PRODOTT} huwa kontra-indikat f'pazjenti:
English: The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response.
Maltese: Id-doża għandha tkun individwalizzata skont il-livelli bażi ta' livelli ta' LDL-C, l-għan tal-kura u rrispons tal-pazjent.
English: The MAH proposes the inclusion of the contraindication in patients during pregnancy, while breastfeeding and in women of childbearing potential not using appropriate contraceptive measures with a cross reference to section 4.3 of the SmPC.
Maltese: Il-kontra-indikazzjonijiet fir-rigward tal-interazzjonijiet tal-mediċini ma ġewx inklużi f'din is-Sezzjoni minħabba li dawn huma inidirizzati fis-Sezzjoni 4.5.
English: The MAH considered it important that physicians be aware of the potential increased risk in this population and monitor these patients for skeletal muscle effects, and a cross-reference to section 4.4 has been added referring to precautionary information regarding patient history of renal impairment as a potential risk factor for development of rhabdomyolysis and recommending closer monitoring for muscle symptoms.
Maltese: - Reviżjoni tad-dejta tal-provi kliniċi tal-MAH ma uritx tħassib dwar is-sigurtà fil-muskoli filpopolazzjoni b'indeboliment tal-kliewi u reviżjoni tar-riċensjoni medika tissuġġerixxi li statins jistgħu jintużaw b'mod sigur f'pazjenti b'mard kroniku tal-kliewi (CKD). Il-MAH ikkunsidra li huwa importanti li t-tobba jkunu konxji taż-żieda tar-riskji potenzjali f'din il-popolazzjoni u li jikkontrollaw dawn il-pazjenti għal effetti fil-muskoli skeletali, u ġiet miżjuda kontra-referenza għas-sezzjoni 4.4 li tirreferi għal informazzjoni ta' prekawzjoni fir-rigward tal-istorja ta' indeboliment fil-kliewi tal-pazjent bħala fattur potenzjali ta' riskju għall-iżvilupp ta' ħabdomijoliżi u tirrakkomanda kontroll aktar mill-viċin għal sintomi fil-muskoli.