FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 7 Trial 4: Changes from baseline in body weight at week 56
Maltese: Tabella 7 Prova 4: Tibdil mil-linja bażi fil-piż tal-ġisem f'ġimgħa 56
English: The mean apparent volume of distribution after subcutaneous administration is 20-25 L (for a person weighing approximately 100 kg).
Maltese: Il-volum apparenti medju tad-distribuzzjoni wara l-għoti taħt il-ġilda hu ta' 20-25 L (għal persuna li tiżen madwar 100 kg).
English: Proportion of patients losing ≥5% body weight at week 32, % (95% CI) Proportion of patients losing >10% body weight at week 32 % (95% CI)
Maltese: Bidla medja f'ġimgħa 32, % (95% CI) Bidla medja f'ġimgħa 32, kg (95% CI) Proporzjon ta' pazjenti li tilfu ≥5% talpiż tal-ġisem f'ġimgħa 32, % (95% CI) Proporzjon ta' pazjenti li tilfu >10% talpiż tal-ġisem f'ġimgħa 32, % (95% CI)
English: In the 56-week part of trial 1, fewer patients treated with liraglutide had developed type 2 diabetes mellitus compared to patients treated with placebo (0.2% vs. 1.1%).
Maltese: Fil-parti ta' prova 1 li damet 56 ġimgħa, inqas pazjenti kkurati b'liraglutide kienu żviluppaw dijabete mellitus ta' tip 2 meta mqabbla ma' pazjenti kkurati bi plaċebo (0.2% vs. 1.1%).
English: Treatment with liraglutide significantly improved glycaemic parameters across sub-populations with normoglycaemia, pre-diabetes and type 2 diabetes mellitus.
Maltese: Il-kura b'liraglutide tejbet b'mod sinifikanti il-parametri gliċemiċi fis-sottopopolazzjonijiet kollha b'normogliċemija, predijabete u dijabete mellitus ta' tip 2.
English: (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).
Maltese: 1.8 mg, 2.4 mg u 3.0 mg.
English: After first use: Store below 30°C or store in a refrigerator (2°C-8°C).
Maltese: Aħżen f'temperatura taħt 30°C jew aħżen fi friġġ (2°C-8°C).
English: Adverse reactions are listed by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassi tas-sistemi u tal-organi u l-frekwenza.
English: • Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation - these usually go away after a few days or weeks.
Maltese: • Dardir (nawsja), rimettar, dijarea, stitikezza - dawn normalment jgħaddu wara ftit jiem jew ġimgħat
English: Specific data on weight loss, responders, time course and cumulative distribution of weight change (%) for trials 1-4 are presented in tables 3-7 and figures 1, 2 and 3.
Maltese: Dejta speċifika dwar it-telf fil-piż, dawk li rrispondew, iż-żmien li ttieħed u d-distribuzzjoni kumulattiva tal-bidla fil-piż (%) għall-provi 1-4 huma ppreżentati fit-tabelli 3-7 u l-figuri 1-4.
English: At week 160, while on treatment, 3% treated with Saxenda and 11% treated with placebo were diagnosed with type 2 diabetes mellitus.
Maltese: Fil-160 ġimgħa, waqt li kienu fuq it-trattament,, 3% li kienu ttrattati b'Saxenda u 11% li kienu ttrattati bi plaċebo ġew iddijanjostikati bid-dijabete mellitus ta' tip 2.
English: Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin
Maltese: Ipogliċemija f'pazjenti bid-dijabete mellitus ta' tip 2 ittrattati bl-insulina
English: Proportion of patients losing ≥5% body weight at week 56, % (95% CI)
Maltese: Bidla medja f'ġimgħa 56, % (95% CI)
English: For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are means, changes from baseline at week 160 are estimated means (least-squares) and treatment contrasts at week
Maltese: Għall-piż tal-ġisem, HbA1c, FPG, pressjoni tad-demm u ċirkonferenza tal-qadd, il-valuri fil-linja bażi huma medji, il-bidliet mil-linja bażi f'ġimgħa 160 huma medji stmati (least-squares) u l-kuntrasti tal-kura f'ġimgħa 160 huma differenzi stmati tal-kura.
English: You can select up to 3.0 mg per dose.
Maltese: Tista' tagħżel sa 3.0 mg għal kull doża.
English: 2.4 mg left
Maltese: 2.4 mg darba kuljum
English: Saxenda is administered once daily at any time, independent of meals.
Maltese: Saxenda jingħata darba kuljum fi kwalunkwe ħin, indipendentement mill-ikel.
English: If you have diabetes, do not use Saxenda as a replacement for insulin.
Maltese: Jekk għandek id-dijabete, tużax Saxenda bħala sostitut għall-insulina.
English: Mean baseline HbA1c was 8.7 and had improved after 3 years by 1.2 % in patients assigned to liraglutide and by 0.8 % in patients assigned to placebo.
Maltese: Il-medja tal-HbA1c fil-linja bażi kienet ta' 8.7 u wara 3 snin kienet tjiebet b'1.2 % f'pazjenti li kienu ngħataw liraglutide u b'0.8 % f'pazjenti li kienu ngħataw plaċebo.
English: (such as diabetes, high blood pressure, abnormal levels of fats in the blood or breathing problems during sleep called ‘obstructive sleep apnoea').
Maltese: (bħal dijabete, pressjoni tad-demm għolja, livelli mhux normali ta' xaħmijiet fid-demm jew problemi tan-nifs waqt l-irqad li jissejħu ‘apnea ostruttiva waqt l-irqad').
English: 1 ml of solution contains 6 mg of liraglutide*.
Maltese: Millilitru ta' soluzzjoni fih 6 mg ta' liraglutide*.
English: Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg.
Maltese: Kull pinna fiha 3 ml ta' soluzzjoni u kapaċi tforni dożi ta' 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg u 3.0 mg.
English: The hazard ratio and 95% CI is 0.33 [0.12; 0.90] for liraglutide versus placebo.
Maltese: 12; 0.90] għal liraglutide kontra l-plaċebo.
English: Caring for your pen
Maltese: Għatu tal pinna
English: Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg
Maltese: Kull pinna fiha 3 ml ta' soluzzjoni u kapaċi tforni dożi ta' 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg u 3.0 mg
English: The efficacy and safety of liraglutide for weight management in conjunction with reduced calorie intake and increased physical activity were studied in four phase 3 randomised, double-blind, placebocontrolled trials which included a total of 5,358 patients.
Maltese: L-effikaċja u s-sigurtà ta' liraglutide għall-immaniġġjar tal-piż flimkien ma' teħid imnaqqas ta' kaloriji u żieda fl-attività fiżika ġew studjati f'erba' provi ta' fażi 3, double-blind, ikkontrollati bi plaċebo, li fihom il-pazjenti ntgħażlu b'mod każwali, li kienu jinkludu total ta' 5,358 pazjent.
English: Flatulence Eructation Abdominal distension
Maltese: Reazzjonijiet allerġiċi
English: In patients treated with GLP-1 receptor agonists, there have been reports of acute renal failure.
Maltese: F'pazjenti kkurati b'agonisti għar-riċetturi ta' GLP-1, kien hemm rapporti ta' insuffiċjenza renali akuta.
English: • Allergic reactions including skin rash
Maltese: • Reazzjonijiet allerġiċi li jinkludu raxx fil-ġilda
English: A clinically relevant interaction with active substances with poor solubility or narrow therapeutic index such as warfarin cannot be excluded.
Maltese: Ma tistax tiġi eskluża interazzjoni klinikament rilevanti ma' sustanzi attivi b'solubilità baxxa jew b'indiċi terapewtiku żgħir bħal warfarin.
English: Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be selected with the dose selector.
Maltese: Dożi ta' 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg jew 3.0 mg iridu jintgħażlu bisselettur tad-doża.
English: Saxenda is not recommended for use in patients with severe renal impairment (creatinine clearance <30 ml/min) including patients with end-stage renal disease (see sections 4.4, 4.8 and 5.2).
Maltese: L-esperjenza terapewtika f'pazjenti ta' ≥75 sena hi limitata u l-użu f'dawn il-pazjenti mhuwiex rakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: The change in heart rate was reversible upon discontinuation of liraglutide (see section 4.4).
Maltese: Il-bidla fir-rata ta' taħbit tal-qalb kienet riversibbli malli twaqqaf liraglutide (ara sezzjoni 4.4).
English: Liraglutide does not increase energy expenditure compared to placebo.
Maltese: Liraglutide ma jżidx ilkonsum tal-enerġija meta mqabbel mal-plaċebo.
English: See section 4 for the warning signs of low blood sugar.
Maltese: Ara sezzjoni 4 għal sinjali ta' twissija ta' livell baxx ta' zokkor fid-demm.
English: For body weight, HbA1c, FPG, blood pressure and waist circumference, baseline values are means, changes from baseline at week 56 are estimated means (least-squares) and treatment contrasts at week 56
Maltese: Għall-piż tal-ġisem, HbA1c, FPG, pressjoni tad-demm u ċirkonferenza tal-qadd, il-valuri fil-linja bażi huma medji, il-bidliet mil-linja bażi f'ġimgħa 56 huma medji stmati (least-squares) u l-kuntrasti talkura f'ġimgħa 56 huma differenzi stmati tal-kura.
English: Also, in these patients documented symptomatic hypoglycaemia was reported by 43.6% of patients treated with Saxenda and in 27.3% of patients treated with placebo.
Maltese: Barra minn hekk, f'dawn il-pazjenti, ipogliċemija sintomatika dokumentata ġiet irrappurtata minn 43.6% tal-pazjenti kkurati b'Saxenda u f'27.3% tal-pazjenti kkurati bi plaċebo.
English: In trial 4, more patients maintained the weight loss achieved prior to treatment initiation with liraglutide than with placebo (81.4% and 48.9%, respectively).
Maltese: Fi prova 4, aktar pazjenti żammew it-telf fil-piż li kien inkiseb qabel il-bidu tal-kura b'liraglutide milli bil-plaċebo (81.4% u 48.9%, rispettivament).
English: 1.8 mg once a day
Maltese: 1.8 mg darba kuljum
English: The dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one week intervals to improve gastro-intestinal tolerability (see table 1).
Maltese: Id-doża għandha tiżdied għal 3.0 mg darba kuljum f'inkrementi ta' 0.6 mg b'intervalli ta' mill-inqas ġimgħa biex tittejjeb it-tollerabilità gastrointestinali (ara tabella 1).
English: The predicted mean weight loss in early responders who complete 1 year of treatment is 11.2% of their baseline body weight (9.7% for males and 11.6% for females).
Maltese: It-telf fil-piż medju mbassar f'dawk li rrispondew kmieni li jtemmu sena ta' kura hu ta' 11.2% tal-piż tal-ġisem tagħhom fil-linja bażi (9.7% għall-irġiel u 11.6% għan-nisa).
English: Dose escalation 4 weeks
Maltese: Eskalazzjoni tad-doża 4 ġimgħat
English: • Trial 4 (SCALE Maintenance - 1923): A 56-week trial assessing body weight maintenance and weight loss in 422 randomised (305 completers) obese and overweight patients with hypertension or dyslipidaemia after a preceding weight loss of ≥5% induced by a low-calorie diet.
Maltese: Prova li damet 56 ġimgħa li evalwat il-manteniment tal-piż tal-ġisem u t-telf fil-piż f'422 pazjent li kellhom obeżità u piż żejjed, li ntgħażlu b'mod każwali (305 temmew il-prova), bi pressjoni għolja jew dislipidemija wara telf fil-piż qabel ta' ≥5% ikkaġunat minn dieta b'kaloriji baxxi.
English: All 3,731 patients were randomised to 56 weeks of treatment and the 2,254 patients with pre-diabetes at screening were randomised to 160 weeks of treatment.
Maltese: Kull wieħed mit-3,731 pazjent intgħażlu b'mod arbitrarju għal 56 ġimgħa ta' trattament u l-2,254 pazjent bi predijabete fil-ħin tal-evalwazzjoni intgħażlu b'mod arbitrarju għal 160 ġimgħa ta' trattament.
English: Liraglutide exposure was decreased by 13-23% in patients with mild to moderate hepatic impairment compared to healthy subjects.
Maltese: L-espożizzjoni ta' liraglutide tnaqqset bi 13-23% f'pazjenti b'indeboliment tal-fwied ħafif għal moderat meta mqabbel ma' persuni f'saħħithom.
English: Needle
Maltese: Nawsja
English: Baseline values are means, changes from baseline at week 32 are estimated means (leastsquares) and treatment contrasts at week 32 are estimated treatment differences (95% CI).
Maltese: (least-squares) u l-kuntrasti tal-kura f'ġimgħa 32 huma differenzi stmati tal-kura (95% CI).
English: • Problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth
Maltese: • Problemi li jaffettwaw l-istonku u l-imsaren, bħal indiġestjoni (dispepsija), infjammazzjoni fil kisja tal-istonku (gastrite), skumdità fl-istonku, uġigħ fil-parti ta' fuq tal-istonku, ħruq ta'
English: Waist circumference, cm
Maltese: Ċirkonferenza tal-qadd, ċm
English: There was no clinically relevant effect on the overall exposure of either ethinylestradiol or levonorgestrel.
Maltese: Ma kien hemm l-ebda effett klinikament rilevanti fuq l-espożizzjoni totali kemm ta' ethinyloestradiol kif ukoll ta' levonorgestrel.
English: Liraglutide regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake.
Maltese: Liraglutide jirregola l aptit billi jżid is-sensazzjonijiet ta' stonku mimli u xaba', filwaqt li jnaqqas sensazzjonijiet ta' ġuħ u lkonsum prospettiv tal-ikel, u b'hekk iwassal għat-tnaqqis fit-teħid tal-ikel.
English: Treatment with liraglutide significantly improved systolic blood pressure and waist circumference compared with placebo (tables 3, 4 and 5).
Maltese: Il-kura b'liraglutide tejbet b'mod sinifikanti il-pressjoni sistolika tad-demm u ċ-ċirkonferenza tal-qadd meta mqabbla mal-plaċebo (tabelli 3, 4 u 5).
English: 1.2 mg once a day
Maltese: 1.2 mg darba kuljum
English: Early responders were defined as patients who achieved ≥5% weight loss after 12 weeks on treatment dose of liraglutide (4 weeks of dose escalation and 12 weeks on treatment dose).
Maltese: Dawk li rrispondew kmieni kienu definiti bħala pazjenti li kisbu telf fil-piż ta' ≥5% wara 12-il ġimgħa fuq kura b'doża ta' liraglutide (4 ġimgħat ta' eskalazzjoni tad-doża u 12-il ġimgħa fuq id-doża talkura).
English: • Inflamed gall bladder
Maltese: • Ġebel fil-marrara
English: Liraglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner which results in a lowering of fasting and post-prandial glucose.
Maltese: Liraglutide jistimula s-sekrezzjoni tal-insulina u jbaxxi s-sekrezzjoni ta' glucagon b'mod li jiddependi mill-glucose li jirriżulta fi tnaqqis ta' glucose fl-istat sajjem u dak ta' wara l-ikel.
English: Inner needle cap
Maltese: Bidla Linja bażi
English: • Trial 1 (SCALE Obesity & Pre-Diabetes - 1839): A total of 3,731 patients with obesity (BMI
Maltese: • Prova 4 (SCALE Manteniment - 1923):
English: This makes sure that the solution flows.
Maltese: Jista' jkun li mhux il-pakketti taddaqsijiet kollha jkunu fis-suq.
English: Your pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32 G.
Maltese: Il-pinna tiegħek hi maħsuba biex tintuża mal-labar NovoFine jew NovoTwist li jintremew wara li jintużaw u li jkollhom tul ta' mhux iżjed minn 8 mm u rquqija sa 32 G.
English: The starting dose is 0.6 mg once daily.
Maltese: Fil-bidu d-doża għandha tkun ta' 0.6 mg darba kuljum.
English: Thyroid disease
Maltese: Mard tat-tirojde
English: Dizziness Dysgeusia
Maltese: Indeboliment tal-fwied
English: Consult your doctor before you continue.
Maltese: Ikkonsulta mat-tabib tiegħek qabel ma tkompli.
English: Nausea Vomiting Diarrhoea Constipation
Maltese: Telf ta' fluwidu u deidratazzjoni
English: 1 ml solution for injection contains 6 mg liraglutide.
Maltese: Millilitru ta' soluzzjoni għall-injezzjoni fih 6 mg ta' liraglutide.
English: The 160-week part of trial 1 assessed time to onset of type 2 diabetes in the 2,254 randomised patients with pre-diabetes (1,128 completers).
Maltese: Il-parti ta' prova 1 li damet 160 ġimgħa evalwat iż-żmien sakemm ħarġet id-dijabete tat-tip 2 fl2,254 pazjent bi predijabete li ntgħażlu b'mod arbitrarju (1,128 li temmew il-prova).
English: From clinical trials and post-marketing use of liraglutide overdoses have been reported up to 72 mg (24 times the recommended dose for weight management).
Maltese: Mill-provi kliniċi u l-użu wara t-tqegħid fis-suq ta' liraglutide, ġew irrappurtati dożi eċċessivi sa 72 mg (24 darba aktar mid-doża rrakkomandata għall-immaniġġjar tal-piż).
English: Liraglutide did not change the overall exposure of paracetamol following a single dose of 1,000 mg. Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.
Maltese: Is-Cmax ta' paracetamol tnaqqas b'31% u t-tmax medjan ittardja b'sa 15-il minuta.
English: C Count slowly:
Maltese: Meta tibda tuża l-pinna:
English: Your pen is a pre-filled dial-a-dose pen.
Maltese: Tużax l-iskala tal-pinna.
English: Outer needle cap
Maltese: U MNEJN GĦANDU JINGĦATA
English: The pen can dial up to a maximum of 3.0 mg.
Maltese: Il-pinna tista' tagħżel sa massimu ta' 3.0 mg.
English: Mean change at week 56, % (95% CI) Mean change at week 56, kg (95% CI)
Maltese: Bidla medja f'ġimgħa 56, kg (95% CI)
English: Pack sizes of 1, 3 or 5 pre-filled pens.
Maltese: Daqsijiet tal-pakkett ta' 1, 3, jew 5 pinen mimlija għal-lest.
English: Proportion of patients losing >10% body weight at week 56, % (95% CI)
Maltese: Proporzjon ta' pazjenti li tilfu >10% talpiż tal-ġisem f'ġimgħa 56, % (95% CI)
English: Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.
Maltese: Ilbijodisponibilità assoluta ta' liraglutide wara l-għoti taħt il-ġilda hi ta' madwar 55%.
English: The 0 must line up with the dose pointer.
Maltese: Iż-0 irid jiġi bi dritt l-indikatur tad-doża.
English: Antibody formation has not been associated with reduced efficacy of liraglutide.
Maltese: Il-formazzjoni ta' antikorpi ma kinitx assoċjata ma' effikaċja mnaqqsa ta' liraglutide.
English: How to store Saxenda
Maltese: X'inhu Saxenda
English: A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%.
Maltese: 15%; is-Cmax naqas b'27%.
English: • a BMI of 30 kg/m² or greater (obese) or
Maltese: • BMI ta' 30 kg/m² jew aktar (obeżi) jew
English: 0.6 mg once a day
Maltese: Eżempju 0.6 mg magħżula
English: Saxenda should not be used in children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Saxenda m'għandux jintuża fi tfal u adolexxenti taħt l-età ta' 18-il sena.
English: In mouse models of atherosclerosis, liraglutide prevented aortic plaque progression and reduced inflammation in the plaque.
Maltese: Barra minn hekk, liraglutide kellu effett benefiku fuq il-lipidi filplażma.
English: Saxenda should not be used in combination with another GLP-1 receptor agonist.
Maltese: Saxenda m'għandux jintuża flimkien ma' agonist ieħor għar-riċettur GLP-1.
English: Hyperglycaemia in insulin treated patients with diabetes mellitus
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Figure 3 Change from randomisation (week 0) in body weight (%) by time in trial 4
Maltese: Figura 4 Bidla mill-għażla b'mod każwali (ġimgħa 0) fil-piż tal-ġisem (%) skont iż-żmien fi prova 4
English: Weight loss response after 12 weeks with liraglutide (3.0 mg) treatment
Maltese: Rispons għat-telf fil-piż wara 12-il ġimgħa ta' kura b' liraglutide (3.0 mg)
English: • you are taking medicines for diabetes called ‘sulfonylurea' (such as glimepiride or glibenclamide) or if you are taking insulin - you may get low blood sugar (hypoglycaemia)
Maltese: • qed tieħu mediċini għad-dijabete msejħa ‘sulfonylurea' (bħal glimepiride jew glibenclamide) jew qed/a tieħu l-insulina- jista' jkollok livell baxx ta' zokkor fid-demm (ipogliċemija) meta tuża dawn il-mediċini ma' Saxenda.
English: Saxenda is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2).
Maltese: Saxenda mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment epatiku sever u għandu jintuża b'kawtela f'pazjenti b'indeboliment epatiku ħafif jew moderat (ara sezzjonijiet 4.4 u 5.2).
English: When initiating Saxenda, it should be considered to reduce the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.
Maltese: Meta tibda Saxenda, wieħed għandu jikkunsidra li jnaqqas id-doża ta' insulina jew ta' sustanzi li jistimulaw is-sekrezzjoni tal-insulina (bħal sulfonylureas) mogħtija fl-istess ħin biex tnaqqas ir-riskju ta' ipogliċemija.
English: • Faster pulse.
Maltese: Kemm fadal soluzzjoni?
English: There are limited data from the use of liraglutide in pregnant women.
Maltese: Hemm dejta limitata dwar l-użu ta' liraglutide f'nisa tqal.
English: Pregnancy and breast-feeding
Maltese: Infjammazzjoni tal-frixa
English: and >10% weight loss with liraglutide than with placebo (tables 3-5).
Maltese: Fil-popolazzjonijiet kollha tal-provi, proporzjonijiet akbar tal-pazjenti kisbu telf fil-piż ta' ≥5% u >10% b'liraglutide milli bil-plaċebo (tabelli 3-5).
English: There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis.
Maltese: Hemm esperjenza limitata f'pazjenti b'mard infjammatorju tal-imsaren u gastroparesi dijabetika.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on posology can be made.
Maltese: It-tagħrif li hemm disponibbli bħalissa huwa deskritt f'sezzjonijiet 4.8, 5.1 u 5.2 iżda ma tista' ssir ebda rakkomandazzjoni dwar pożoloġija.
English: 31 May 2016 EMA/262389/2016
Maltese: EMA/262389/2016
English: Thymus vulgaris L. or Thymus zygis L., herba and Primula veris L. or Primula elatior (L.) Hill, radix
Maltese: Thymus vulgaris L. jew Thymus zygis L., herba and Primula veris L. jew Primula elatior (L.)
English: The HMPC conclusions only cover combinations of certain thyme and primula root preparations which are obtained using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or glycerol) to dissolve compounds and form a liquid extract.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss kombinazzjonijiet ta' ċerti preparazzjonijiet tas-sagħtar u lprimula li huma miksuba bl-użu ta' teknika għall-estrazzjoni ta' komponenti billi l-materjal tal-pjanta jitpoġġa f'solvent (bħall-etanol jew gliċerol) biex jinħallu l-komponenti u jiġi ffurmat estratt likwidu.
English: Further information on the HMPC assessment of thyme and primula root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Maltese: Dan ifisser li hemm informazzjoni biblijografika li tipprovdi evidenza xjentifika tal-effikaċja u s-sigurtà tagħhom meta jintużaw b'dan ilmod, li tkopri perjodu ta' mill-inqas 10 snin fl-UE.
English: Thyme and primula root
Maltese: Aktar informazzjoni dwar il-mediċini li fihom is-sagħtar u l-primula
English: The way thyme and primula root work is not fully known, but laboratory studies indicate that thyme may have an action against microbes and a muscle relaxant effect while primula root may increase production of sputum in the airways, thereby diluting phlegm and helping to bring it up.
Maltese: Il-mod kif jaħdmu s-sagħtar u l-primula għadu mhux magħruf għalkollox, iżda studji fil-laboratorju jindikaw li s-sagħtar jista' jkollu azzjoni kontra l-mikrobi u effett ta' rilassant fuq il-muskoli filwaqt li lprimula tista' żżid il-produzzjoni tal-bżieq fil-passaġġi tal-arja, b'hekk jiġu dilwiti l-bili u tgħin sabiex ittellagħhom.
English: What are thyme and primula root?
Maltese: X'inhuma s-sagħtar u l-primula?
English: What are the HMPC conclusions on their medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użijiet mediċinali tagħhom?
English: In its assessment, the HMPC considered a number of clinical studies with thyme and primula root showing that these medicines help reduce coughs in adults.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra għadd ta' studji kliniċi bit-timu u l-primula li juru li dawn ilmediċini jgħinu fit-tnaqqis tas-sogħla fl-adulti.
English: The HMPC concluded that certain thyme and primula root preparations can be used as an expectorant (a medicine that helps bring up phlegm) for productive (chesty) coughs in adults.
Maltese: L-HMPC ikkonkluda li ċerti preparazzjonijiet tat-timu u l-primula jistgħu jintużaw bħala espettorant (mediċina li tgħin biex jittellgħu l-bili) għal sogħa produttiva (mis-sider) fl-adulti.