FrancophonIA/ELRC3.0 huggingface dataset:
English: In the overall population, including both asymptomatic and symptomatic patients, trimetazidine failed to demonstrate a benefit on both ergometric (total exercise duration, time to onset of 1mm ST and time to onset angina) and clinical endpoints.
Maltese: Fil-popolazzjoni ġenerali, li kienet tinkludi kemm pazjenti asintomatiċi kif ukoll pazjenti sintomatiċi, trimetazidine naqas milli juri benefiċċju fuq l-endpoints kemm ergometriċi (dewmien totali tal-eżerċizzju, ħin sal-bidu ta' 1mm ST u ħin sal-bidu ta' anġina) kif ukoll dawk kliniċi.
English: - Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders, - Severe renal impairment (creatinine clearance < 30ml/min).
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1. - Marda ta' Parkinson, sintomi ta' Parkinson, tregħid, sindrome tas-saqajn bla kwiet, u disturbi oħra relatati fil-moviment, - Indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' < 30 ml/min).
English: The safety and efficacy of trimetazidine in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' trimetazidine fit-tfal ta' taħt it-18-il sena ma ġewx determinati s'issa.
English: Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients.
Maltese: Trimetazidine jista' jikkawża jew jiggrava s-sintomi ta' Parkinson (tregħid, akinesija, ipertonija), li għandhom jiġu investigati b'mod regolari, speċjalment f'pazjenti anzjani.
English: No significant difference between groups could be found for the other secondary endpoints (total exercise duration, total workload and clinical endpoints).
Maltese: Ma setgħet tinstab l-ebda differenza sinifikanti bejn il-gruppi għallendpoints sekondarji l-oħra (id-dewmien totali tal-eżerċizzju, il-workload totali u l-endpoints kliniċi).
English: Trimetazidine does not have haemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience (see section 4.8), which may affect ability to drive and use machines.
Maltese: Trimetazidine m'għandux effetti emodinamiċi fl-istudji kliniċi, madankollu fl-esperjenza ta' wara ttqegħid tal-prodott fis-suq kienu osservati sturdament u ngħas (ara sezzjoni 4.8), li jistgħu jaffettwaw il-ħila biex issuq u tħaddem magni.
English: Dizziness, headache
Maltese: Sturdament, uġigħ ta' ras
English: The dose is one tablet of 20mg or 1 ml (20 drops) of oral drop solution of trimetazidine three times a day during meals.
Maltese: Id-doża hija pillola waħda ta' 20 mg jew 1 ml (20 qatra) ta' soluzzjoni għall-qtar orali ta' trimetazidine tliet darbiet kuljum waqt l-ikel.
English: Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.
Maltese: Ittqawwija tal-ossidazzjoni tal-glukożju ttejjeb il-proċessi ċellulari tal-enerġija, u b'hekk jinżamm metaboliżmu tajjeb tal-enerġija waqt iskemija.
English: Member State EU/EEA
Maltese: EU/EEA
English: Applicant
Maltese: Applikant
English: 1 VICH GL6: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal
Maltese: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal
English: Name
Maltese: Isem
English: Germany Norbrook Laboratories Limited
Maltese: L-Olanda Norbrook Laboratories Limited
English: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en duration of eprinomectin excretion and the keep off from water bodies two to five weeks after treatment.
Maltese: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305:
English: The benefit of the products is treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages, mange mites, lice and horn flies by using this product.
Maltese: Il-benefiċċju tal-prodotti huwa l-kura u l-kontroll ta' infezzjonijiet minn roundworms gastrointestinali (adulti u larva fir-raba' stadju), lungworms (adulti u larva fir-raba' stadju), warbles (stadji parassitiċi, mange mites, qamel u horn flies permezz tal-użu ta' dan il-prodott.
English: Direct therapeutic benefit
Maltese: Benefiċċju terapewtiku dirett
English: Eprinomectin has a n-octanol/water partition coefficient (KOW, expressed as log KOW) of 6.5 which was tested in a valid KOW study according to guideline 117 of the Organisation for Economic Co-operation and Development (OECD)4.
Maltese: Eprinomektin għandu koeffiċjent tal-partizzjoni n-octanol/ilma (KOW, espress bħala log KOW) ta' 6.5 li ġie ttestjat fi studju validu tal-KOW skont il-linja gwida 117 tal-Organizzazzjoni għall-Kooperazzjoni u lIżvilupp Ekonomiċi (OECD)4.
English: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf for the active ingredient in order to assess the fate of the substance and the effects on organisms that might occur in the environment by the use of the product.
Maltese: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf sustanza attiva sabiex jiġi vvalutat id-destin tas-sustanza u l-effetti li jistgħu jseħħu fuq organiżmi flambjent mill-użu tal-prodott.
English: 4.5 Special precautions for use iii.
Maltese: 4.5 Prekawzjonijiet speċjali għall-użu iii.
English: Therefore, a referral to CVMP under Article 33(4) of Directive 2001/82/EC was made.
Maltese: Għalhekk sar riferiment lis-CVMP skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: Because eprinomectin is a parasiticide a Phase II assessment according to VICH GL38 was presented
Maltese: Minħabba li eprinomektin huwa parassitiċida ġiet ippreżentata valutazzjoni tal-Fażi II skont VICH GL38 għas
English: Potential serious risks were identified during the decentralised procedure by Germany who considered that eprinomectin might potentially be a PBT (persistent, bioaccumulative and toxic) substance.
Maltese: Matul il-proċedura deċentralizzata ġew identifikati riskji serji potenzjali mill-Ġermanja li qieset li eprinomektin jista' potenzjalment ikun sustanza PBT (persistenti, bijoakkumulattiva u tossika).
English: In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Maltese: Sabiex jindirizza t-tħassib imqajjem mir-riferiment, l-applikant ipprovda valutazzjoni tar-riskju ambjentali (ERA) skont il-linji gwida tal-VICH GL61 u GL382 u f'konformità mal-linja gwida tas-CVMP b'appoġġ tal-linji gwida tal-VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005)3.
English: The application in question, submitted via the decentralised procedure, is a ‘hybrid' application according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex Pour-On Solution for Beef and Dairy Cattle authorised in the United Kingdom.
Maltese: L-applikazzjoni in kwistjoni, ippreżentata permezz tal-proċedura deċentralizzata, hija applikazzjoni ‘ibrida' skont l-Art. 13(3) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza Eprinex Soluzzjoni Li Titferra' għall-Baqar taċ-Ċanga u tal-Ħalib awtorizzat fir-Renju Unit.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle shows that the product is not expected to pose a risk for the environment when used as recommended in the SPC which includes following the recommended RMM.
Maltese: Wara li kkunsidra d-dejta ġenerali kollha ppreżentata bil-miktub, is-CVMP ikkonkluda li l-ERA għal Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Baqar taċ-Ċanga u tal-Ħalib turi li l-prodott mhuwiex mistenni jkun ta' riskju għall-ambjent meta jintuża kif rakkomandat fl-SPC li jinkludi l-RMM rakkomandati.
English: These characteristics are also addressed in the SPC and the package leaflet with the information "... is persistent in soils and may accumulate in sediments ".
Maltese: Dawn il-karatteristiċi ġew indirizzati wkoll fl-SPC u filfuljett tal-pakkett bl-informazzjoni "... huwa persistenti fil-ħamrija u jista' jakkumula fis-sedimenti".
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle.
Maltese: Ir-riskju għal ekosistemi akkwatiċi u l-fawna tad-demel jista 'jitnaqqas billi jiġi evitat użu wisq frekwenti u ripetut ta' eprinomectin (u prodotti tal-istess klassi antelmintiċi) fil-baqar.
English: Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments.
Maltese: Eprinomectin huwa tossiku ħafna għall-organiżmi akkwatiċi, huwa persistenti fil-ħamrija u jista 'jakkumula fis-sedimenti.
English: Northern Ireland
Maltese: L-Irlanda ta' fuq
English: Valid data on the acute and developmental toxicity of eprinomectin to dung beetle larvae were provided which indicated that risk quotient values for dung insects were >1.
Maltese: Ġiet ipprovduta dejta valida dwar it-tossiċità akuta u tal-iżvilupp ta' eprinomektin għal-larva tal-ħanfus tad-demel li indikat li l-valuri tal-kwozjent tar-riskju għall-insetti tad-demel kienu >1.
English: Additionally, risk mitigation measures (RMM) have been considered and proposed for the risk identified for dung insects.
Maltese: Abbażi tar-riskji identifikati fl-ERA RMM ġew proposti biex dan ir-riskju jiġi indirizzat.
English: The ERA was full and complete in terms of data requirements.
Maltese: L-ERA kienet sħiħa u kompluta f'termini ta' rekwiżiti ta' dejta.
English: Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks.
Maltese: Wara t-trattament, l-eskrezzjoni ta 'livelli potenzjalment tossiċi ta' eprinomectin jistgħu jsiru fuq perjodu ta 'diversi ġimgħat.
English: An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Maltese: ERA skont il-linji gwida tal-VICH u tas-CVMP kienet ipprovduta li kien fiha taħlita ta' studji ppubblikati u kkummissjonati mill-applikant u indirizzat l-aspetti kollha ta' riskju ambjentali.
English: Co. Down
Maltese: Down
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin, a synthetic avermectin.
Maltese: Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Baqar taċ-Ċanga u tal-Ħalib fih eprinomektin, avermektin sintetiku.
English: Pour-on solution Cattle Topical use
Maltese: Valutazzjoni tad-dejta ppreżentata
English: Results from a bioaccumulation study according to OECD guideline 3055 demonstrate that eprinomectin is not likely to concentrate to levels that would pose a risk to aquatic organisms.
Maltese: Ir-riżultati minn studju ta' bijoakkumulazzjoni skont il-linja gwida 3055 tal-OECD juru li eprinomektin mhuwiex probabbli li jilħaq livelli ta' konċentrazzjoni li joħolqu riskju għall-organiżmi akwatiċi.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwa tal-prodotti mediċinali veterinarji, speċi tal-annimali, mnejn jingħata, lapplikant fl-Istati Membri
English: Evaluation of the benefit-risk balance
Maltese: Valutazzjoni tal-bilanċ tal-benefiċċju-riskju
English: Eprinomectin fulfils the 'P' criterion as a conclusion from the PBT assessment and has a high adsorption coefficient (KOC).
Maltese: Bħala konklużjoni mill-valutazzjoni tal-PBT eprinomectin jissodisfa l-kriterju 'P' u għandu koeffiċjent għoli ta' adsorbiment (KOC).
English: Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms.
Maltese: Bħal lattoni makroċikliċi oħra, eprinomectin għandu l-potenzjal li jaffettwa ħażin organiżmi mhux immirati.
English: Benefit-risk assessment
Maltese: Valutazzjoni tar-riskju
English: Quality, target animal safety, user safety, residues and resistance were not assessed in this referral procedure, but all risks were addressed during the decentralised procedure.
Maltese: Il-kwalità, is-sigurtà tal-annimal fil-mira, is-sigurtà tal-utent, ir-residwi u r-reżistenza ma kinux ivvalutati f'din il-proċedura ta' riferiment, iżda r-riskji kollha kienu ġew indirizzati matul il-proċedura deċentralizzata.
English: Strength Pharmaceutical form
Maltese: Qawwa għamla farmaċewtika
English: A screening for PBT properties as required by the CVMP guidelines indicated that eprinomectin fulfils the criteria for 'P' and 'T' but it was considered not to be 'B'.
Maltese: Skrinjar għal proprjetajiet PBT kif meħtieġ mil-linji gwida tas-CVMP indika li eprinomektin jissodisfa l-kriterji għal 'P' u 'T' iżda ma kienx meqjus li kien 'B'.
English: Consequently in order to mitigate the risk for dung insects RMM were included in the product information.
Maltese: Konsegwentement, sabiex ir-riskju għall-insetti tad-demel jitnaqqas, ġew inklużi RMM fl-informazzjoni dwar il-prodott.
English: The deriving bioaccumulation potential and the potential for being considered a PBT compound and secondary poisoning were addressed as required by VICH and CVMP guidelines.
Maltese: Il-potenzjal ta' bijoakkumulazzjoni b'riżultat ta' dan u l-potenzjal li jiġi meqjus kompost PBT u avvelenament sekondarju ġew indirizzati kif meħtieġ mil-linji gwida tal-VICH u tas-CVMP.
English: Eprinomectin residues will be introduced into the environment following direct excretion onto pasture.
Maltese: Residwi ta' eprinomektin jiġu introdotti fl-ambjent wara eskrezzjoni diretta fil-mergħa.
English: An ERA was provided for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle which was in accordance with VICH and CVMP guidelines.
Maltese: ERA ġiet ipprovduta għal Norbonex 5 mg/ml Soluzzjoni Li Titferra' għall-Baqar taċ-Ċanga u tal-Ħalib f'konformità mal-linji gwida tal-VICH u tas-CVMP.
English: Other precautions
Maltese: Prekawzjonijiet oħra
English: United Kingdom
Maltese: Stat
English: MA (EU) Number
Maltese: Numru tal-EU
English: Immediate packaging
Maltese: Daqs talpakkett
English: Strength Pharmaceutical form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: References
Maltese: Referenzi
English: 12 December 2016 EMA/868987/2016
Maltese: EMA/868987/2016
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Maltese: 3660 8427 Indirizz tal-email: press@ema.europa.eu
English: The following medicines containing combinations of metformin with other diabetes medicines in the same tablet have been authorised centrally through EMA: pioglitazone/metformin (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) and empagliflozin/metformin (Synjardy).
Maltese: Il-mediċini li ġejjin li fihom kombinazzjonijiet ta' metformin flimkien ma' mediċini oħra tad-dijabete fl-istess pillola ġew awtorizzati ċentralment permezz tal-EMA: (Competact, Glubrava), dapagliflozin/metformin (Ebymect, Xigduo), sitagliptin/metformin (Efficib, Janumet, Ristfor, Velmetia), linagliptin/metformin (Jentadueto), saxagliptin/metformin (Komboglyze), alogliptin/metformin (Vipdomet), canagliflozin/metformin (Vokanamet), vildagliptin/metformin (Eucreas, Icandra, Zomarist) u empagliflozin/metformin (Synjardy).
English: et al., ‘Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus', Cochrane Database Syst Rev, 2010, CD00296.
Maltese: Salpeter, S.R. et al., ‘Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus', Cochrane Database Syst Rev, 2010, CD00296.
English: Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am Geriatr Soc, 2013, Vol. 61, p. 1253.
Maltese: Solini, A. et al., ‘Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the Renal Insufficiency and Cardiovascular Events Italian Multicenter Study', J Am
English: et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
Maltese: Inzucchi, S.E. et al., ‘Metformin in patients with type 2 diabetes and kidney disease: a systematic review', JAMA, 2014, Vol. 312, p. 2668.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Maltese: intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE fit-12/12/2016.
English: et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
Maltese: Richy, F.F. et al., ‘Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study', Diabetes Care, 2014, Vol. 37 (8), p.
English: For example, dapagliflozin/metformin (Ebymect, Xigduo) is not recommended in patients with GFR<60 ml/min; canagliflozin/metformin (Vokanamet) and empagliflozin/metformin (Synjardy) are not recommended in patients with GFR<45 ml/min and should not be started in patients with GFR<60 ml/min.
Maltese: Pereżempju, dapagliflozin/metformin (Ebymect, Xigduo) mhuwiex rakkomandat fuq pazjenti b'GFR<60 ml/min; canagliflozin/metformin (Vokanamet) u empagliflozin/metformin (Synjardy) mhumiex rakkomandati fuq pazjenti b'GFR<45 ml/min u ma għandhomx jinbdew fuq pazjenti b'GFR<60 ml/min.
English: In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
Maltese: Barra minn hekk, il-kombinazzjoni glibenclamide/metformin (Glucovance) ġiet awtorizzata fuq livell nazzjonali.
English: Information for healthcare professionals
Maltese: Informazzjoni għall-pazjenti
English: • The review of metformin-containing medicines concluded that they can now be used in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Maltese: • Ir-rieżami ta' mediċini li fihom metformin ikkonkluda li issa jistgħu jintużaw fuq pazjenti b'indeboliment moderat fil-funzjoni tal-kliewi (GFR=30-59 ml/min).
English: The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' mediċini li fihom metformin inbeda fit-28 ta' Jannar 2016 fuq talba tan-Netherlands, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: • Dehydration (significant loss of body fluids) increases the risk of developing lactic acidosis.
Maltese: • Id-deidratazzjoni (telf sinifikanti tal-fluwidi tal-ġisem) iżżid ir-riskju tal-iżvilupp ta' aċidożi lattika.
English: Use in patients with GFR<30 ml/min is still contraindicated.
Maltese: L-użu fuq pazjenti b'GFR<30 ml/min għadu kontraindikat.
English: However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Maltese: Madankollu, wara li kkunsidrat il-letteratura xjentifika, id-data klinika, l-istudji epidemjoloġiċi u l-linji gwida kliniċi minn korpi mediċi, l-EMA kkonkludiet li l-popolazzjoni kbira ta' pazjenti b'indeboliment moderat fil-funzjoni tal-kliewi tista' tibbenefika mill-użu ta' metformin.
English: • Several fixed-dose combination products containing metformin are available in Europe (see below).
Maltese: • Fl-Ewropa hemm diversi prodotti f'kombinazzjonijiet ta' dożi fissi li fihom metformin (ara hawn taħt).
English: The recommendations were the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.
Maltese: Ir-rakkomandazzjonijiet kienu r-riżultat ta' rieżami li sar mill-EMA ta' mediċini li fihom metformin wara tħassib li l-evidenza xjentifika attwali ma tiġġustifikax kontraindikazzjoni f'pazjenti b'indeboliment moderat fil-funzjoni tal-kliewi.
English: This recommendation has now changed to allow their use in patients with moderately reduced kidney function (GFR=30-59 ml/min).
Maltese: Issa din ir-rakkomandazzjoni nbidlet biex tippermetti li jintużaw fuq pazjenti b'indeboliment moderat fil-funzjoni tal-kliewi (GFR=30-59 ml/min).
English: Richy, F.F.
Maltese: L-opinjoni tas-CHMP
English: The contraindication for patients with severely reduced kidney function will remain (GFR less than 30 ml/min).
Maltese: Il-kontraindikazzjoni għal pazjenti b'indeboliment sever filfunzjoni tal-kliewi ser tibqa' (GFR ta' inqas minn 30 ml/min).
English: On 13 October 2016, the European Medicines Agency (EMA) concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate] = 30-59 ml/min) for the treatment of type 2 diabetes.
Maltese: Fit-13 ta' Ottubru 2016, l-Aġenzija Ewropea għall-Mediċini (EMA) kkonkludiet li mediċini li fihom metformin issa jistgħu jintużaw fuq pazjenti b'indeboliment moderat fil-funzjoni tal-kliewi (GFR [rata ta' filtrazzjoni glomerulari] = 30-59 ml/min) għall-kura tad-dijabete tat-tip 2.
English: However, for patients with only moderately reduced kidney function any risk can be minimised by careful checking of dose and monitoring, allowing these patients to get the benefits these medicines can provide.
Maltese: Madankollu, għal pazjenti b'indeboliment moderat biss fil-funzjoni tal-kliewi kwalunkwe riskju jista' jiġi minimizzat permezz ta' kontroll bir-reqqa tad-doża u monitoraġġ, li jippermetti lil dawn il-pazjenti li jiksbu l-benefiċċji li dawn il-mediċini jistgħu jipprovdu.
English: • Up to now, metformin medicines were not recommended for patients with moderate to severe reduction of kidney function.
Maltese: • S'issa, mediċini li fihom metformin ma kinux rakkomandati għal pazjenti b'indeboliment minn moderat sa sever fil-funzjoni tal-kliewi.
English: These medicines should still not be used in patients with severely reduced kidney function (GFR less than 30 ml/min).
Maltese: Dawn il-mediċini xorta ma għandhomx jintużaw fuq pazjenti b'indeboliment sever fil-funzjoni tal-kliewi (GFR ta' inqas minn 30 ml/min).
English: Type 2 (MEF-1)
Maltese: Tip 2 (MEF-1)
English: Type 3 (Saukett)
Maltese: Tip 3 (Saukett)
English: Haemophilus influenzae type b polysaccharide
Maltese: Haemophilus influenzae polysaccharide tip b
English: (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Maltese: (Polyribosylribitol Phosphate) konjugat għal proteina tat-Tetnu