FrancophonIA/ELRC3.0 huggingface dataset:
English: Plendil contains the active substance felodipine.
Maltese: Plendil fih is-sustanza attiva felodipine.
English: • hypertension;
Maltese: • pressjoni għolja;
English: • stable angina pectoris (a type of angina pectoris that occurs with activity or stress).
Maltese: • anġina pectoris stabbli (tip ta' anġina pectoris li sseħħ b'attività jew stress).
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħrajn tal-SmPC inklużi sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.6 (fertilità, tqala u treddigħ) u 4.8 (effetti sekondarji).
English: The CHMP agreed to include the following contraindications in the product information: hypersensitivity (allergy) to felodipine or to any other ingredients; pregnancy; decompensated heart failure (worsening of symptoms in patients with heart problems); acute myocardial infarction (heart attack); unstable angina pectoris (a type of chest pain that happens suddenly, even at rest or asleep, and which may lead to a heart attack), and certain types of heart valve and bloodflow obstructions.
Maltese: Is-CHMP qabel li jinkludi l-kontraindikazzjonijiet li ġejjin fl-informazzjoni tal-prodott: sensittività eċċessiva (allerġija) għal felodipine jew għal kwalunkwe sustanza oħra; tqala; insuffiċjenza tal-qalb dikumpensata (aggravar tas-sintomi f'pazjenti bi problemi tal-qalb); infart mijokardijaku akut (attakk tal-qalb); anġina pectoris instabbli (tip ta' uġigħ fis-sider li jseħħ f'daqqa, anki waqt il-mistrieħ jew lirqad, u li jista' jwassal għal attakk tal-qalb), u ċertu tipi ta' ostruzzjonijiet tal-valvi tal-qalb u ċċirkolazzjoni.
English: The medicine is available as prolonged release tablets (2.5, 5 and 10 mg) which release the active substance over an extended period of time.
Maltese: Il-mediċina hija disponibbli bħala pilloli ta' rilaxx fit-tul (2.5, 5 u 10 mg) li jirrilaxxaw is-sustanza attiva fuq tul ta' żmien estiż.
English: Plendil is a medicine used to treat hypertension (high blood pressure).
Maltese: Plendil huwa mediċina li tintuża għall-kura ta' ipertensjoni (pressjoni tad-demm għolja).
English: On 23 October 2014, the European Medicines Agency completed a review of Plendil and associated names.
Maltese: Fit-23 ta' Ottubru 2014, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Plendil u ismijiet assoċjati.
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Plendil can be used to treat the following:
Maltese: Wara li rreveda d-dejta disponibbli li tappoġġja l-użu tal-mediċina, is-CHMP qabel li Plendil jista' jintuża għal dan li ġej:
English: Why was Plendil reviewed?
Maltese: Għaliex ġie rivedut Plendil?
English: Plendil and associated names have been authorised in EU Member States through national procedures since 1987.
Maltese: Plendil u ismijiet assoċjati ilhom awtorizzati fl-Istati Membri tal-UE permezz ta' proċeduri nazzjonali mill-1987.
English: In view of this, on 12 November 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Plendil in the EU.
Maltese: Fid-dawl ta' dan, fit-12 ta' Novembru 2013, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Plendil fl-UE.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Plendil should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika fil-Kumitat, kien tal-opinjoni li lSmPCs, it-tikkettar u l-fuljetti ta' tagħrif għandhom jiġu armonizzati madwar l-UE kollha.
English: The Committee also agreed that Plendil should no longer be recommended to treat ‘vasospastic angina pectoris' (another type of angina pectoris caused by spasms in the vessels supplying blood to the heart), because the available data to support this use were considered too limited.
Maltese: Il-Kumitat qabel ukoll li Plendil m'għandux jibqa' jiġi rakkomandat għall-kura ta' ‘anġina pectoris vażospastika' (tip ieħor ta' anġina pectoris ikkawżata minn spażmi fil-vini li jwasslu d-demm għallqalb), minħabba li d-dejta disponibbli li tappoġġja dan l-użu ġiet ikkunsidrata wisq limitata.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses and recommendations for special populations.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet fuq id-dożi u rrakkomandazzjonijiet għal popolazzjonijiet speċjali.
English: As Plendil has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (summary of product characteristics), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Minħabba li Plendil ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali, dan wassal għal diverġenzi madwar l-Istati Membri fil-mod ta' kif tista' tintuża l-mediċina, kif jidher mid-differenzi fl-SmPCs (Sommarju tal-Karatteristiċi tal-Prodott), it-tikkettar u l-fuljetti ta' tagħrif fil-pajjiżi fejn il-mediċina titqiegħed fis-suq.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Plendil and associated names in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn li tiġi armonizzata l-informazzjoni ta' preskrizzjoni għal Plendil u ismijiet assoċjati flUnjoni Ewropea (UE).
English: Oral use blister (PVC/PVDCalu/PET/paper)
Maltese: Użu orali folja (PVC/PVDCalu/PET/karta)
English: 200 mg Film-coated tablet
Maltese: 200 mg Pillola miksija b'rita
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Numru tal-MA (UE) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Ref. EMEA/CHMP/494721/2008
Maltese: EMEA/CHMP/494735/2008
English: Cozaar and associated names, 12,5 mg, 25mg, 50 mg, 100 mg, film-coated tablets is an orally active angiotensin II (Ang- II) receptor antagonist, losartan, acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Maltese: Cozaar u l-ismijiet assoċjati, 12,5 mg, 25 mg, 50 mg, 100 mg, pilloli miksijin b'rita huwa antagonista riċettur tat-tip angiotensin II (Ang- II) attiv oralment, losartan, li jaġixxi fuq is-subtip tar-riċettur AT1, b'hekk jimblokka l-effett ta' Ang-II fil-kaskada tas-sistema ta' anġjotensin tar-renin (RAS).
English: Losartan may also delay progression of diabetic nephropathy and is also indicated for the reduction of renal disease progression in patients with type 2 diabetes, and microalbuminuria (>30 mg/24 hours) or proteinuria (>900 mg/24 hours).
Maltese: Losartan jista' jdewwem ukoll in-nefropatija dijabetika u huwa indikat ukoll għat-tnaqqis tal-progressjoni tal-mard renali f'pazjenti b'dijabete tip 2, u b'mikroalbuminurija (>30 mg/24 sigħat) jew bi proteinurija (>900 mg/24 sigħat).
English: Losartan is indicated for the treatment of hypertension.
Maltese: Losartan huwa indikat għall-kura tal-pressjoni għolja.
English: On 23 February 2007, Denmark presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised summaries of product characteristics, package leaflet and labelling of the medicinal product Cozaar and associated names for the following indications: Treatment of essential hypertension; Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria > 0.5 g/day as part of an antihypertensive treatment; Reduction of risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG; Treatment of chronic heart failure (in patients ≥ 60 years), when treatment with ACE inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication.
Maltese: Fit-23 ta' Frar 2007, id-Danimarka ippreżentat lill-EMEA riferment skont l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata, sabiex jiġu armonizzati s-sommarji tal-karatteristiċi tal-prodott, il-fuljett ta' tagħrif u t-tikketta awtorizzati fuq livell nazzjonali tal-prodott mediċinali Cozaar u l-ismijiet assoċjati għall-indikazzjonijiet li ġejjin:
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar and associated names International Non-Proprietary Name (INN): losartan
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA RIFERIMENT SKOND L-ARTIKOLU 30 GĦAL Cozaar u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): losartan
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, labelling and package leaflet for Cozaar and associated names.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' April 2008 u rrakkomanda l-armonizzazzjoni tal-SPC, tikketta u fuljett ta' tagħrif għal Cozaar u l-ismijiet assoċjati.
English: The full EPAR for Incresync can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Alogliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Maltese: Alogliptin huwa inibitur ta' dipeptidyl-peptidase-4 (DPP 4).
English: Other information about Incresync
Maltese: Informazzjoni oħra dwar Incresync
English: Why is Incresync approved?
Maltese: Għal xiex ġiet approvat Incresync?
English: Incresync is available as tablets (12.5 or 25 mg alogliptin and 30 mg pioglitazone; 12.5 or 25 mg alogliptin and 45 mg pioglitazone) and can only be obtained with a prescription.
Maltese: Incresync huwa disponibbli bħala pilloli (12.5 jew 25 mg alogliptin u 30 mg pioglitazone; 12.5 jew 25 mg alogliptin u 45 mg pioglitazone) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Incresync alogliptin / pioglitazone
Maltese: Sommarju tal-EPAR għall-pubbliku alogliptin / pioglitazone
English: The most common side effects with Incresync (which may affect up to 1 in 10 people) are upper respiratory tract infections (colds), sinusitis, headache, nausea (feeling sick), dyspepsia (heartburn), abdominal pain (tummy ache), pruritus (itching), myalgia (muscle pain), peripheral oedema (swelling in arms and legs) and weight gain.
Maltese: L-effetti sekondarji l-aktar komuni b'Incresync (li jistgħu jolqtu sa 1 minn kull 10) huma infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (irjiħat), sinusite, uġigħ ta' ras, nawsja (tħossok imdardar), dispepsja (ħruq ta' stonku), uġigħ addominali (uġigħ fiż-żaqq), pruritus (ħakk), mijalġja (uġigħ filmuskoli), edema periferali (nefħa fid-dirgħajn u r-riġlejn) u żieda fil-piż.
English: This is a summary of the European public assessment report (EPAR) for Incresync.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Incresync.
English: When added to pioglitazone, the improvement was a fall of 0.47% at a dose of alogliptin of 12.5 mg, and 0.61% for alogliptin 25 mg. Incresync was at least as effective as pioglitazone and metformin in reducing HbA1c.
Maltese: Meta miżjud ma' pioglitazone, it-titjib kien tnaqqis ta' 0.47% b'doża ta' alogliptin ta' 12.5 mg, u 0.61% għal alogliptin 25 mg.
English: Regarding safety, Incresync's safety profile was consistent with that seen with the individual components.
Maltese: Fir-rigward tas-sigurtà, il-profil tas-sigurtà ta' Incresync kien konsistenti ma' dak osservat bil-komponenti individwali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Incresync on 19 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Incresync fil-19 ta' Settembru 2013.
English: What are the risks associated with Incresync?
Maltese: X'inhuma r-riskji assoċjati ma' Incresync?
English: Incresync has been studied in two main studies involving 1,296 patients with type-2 diabetes that was not well controlled by previous treatment.
Maltese: Incresync ġie studjat f'żewġ studji ewlenin li involvew 1,296 pazjent b'dijabete ta' tip 2 li ma kinitx ikkontrollata tajjeb b'kura preċedenti.
English: This summary was last updated in 08-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: 08-2013.
English: How does Incresync work?
Maltese: Kif jintuża Incresync?
English: The dose should be lowered in patients with moderately reduced kidney function.
Maltese: Id-doża għandha titbaxxa f'pazjenti b'funzjoni tal-kliewi moderatament imnaqqsa.
English: A risk management plan has been developed to ensure that Incresync is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Incresync jintuża bl-aktar mod sigur possibbli.
English: By blocking the breakdown of Incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi jimblokka d-degradazzjoni tal-ormoni Incretin fid-demm, alogliptin itawwal l-azzjoni tagħhom fl-istimular tal-frixa biex tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: The active substances in Incresync, alogliptin and pioglitazone, work in different ways to help correct this.
Maltese: Is-sustanzi attivi f'Incresync, alogliptin u pioglitazone, jaħdmu b'modi differenti biex jikkoreġu dan.
English: HbA1c levels were measured after 26 weeks in the first study and 52 weeks in the second study.
Maltese: Il-livelli tal-HbA1c ġew imkejla wara 26 ġimgħa fl-ewwel studju u 52 ġimgħa fit-tieni studju.
English: In addition, the company that markets Incresync will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Incresync se tipproduċi materjal edukattiv għat-tobba li jippreskrivu l-mediċina, li se jkopri r-riskju possibbli ta' insuffiċjenza tal-qalb u kanċer fil-bużżieqa talawrina bit-trattamenti li fihom pioglitazone, il-kriterji għall-għażla tal-pazjenti u l-ħtieġa ta' valutazzjoni regolari tal-kura u li l-kura titwaqqaf jekk il-pazjenti ma jibqgħux jibbenefikaw minnha.
English: The CHMP considered that adding alogliptin to existing treatment with pioglitazone with or without metformin had shown to produce modest but clinically relevant improvements in HbA1c.
Maltese: Is-CHMP qies li ż-żieda ta' alogliptin ma' kura eżistenti b'pioglitazone bi jew mingħajr metformin intweriet li tipproduċi titjib modest iżda klinikament rilevanti fl-HbA1c.
English: Incresync can also be used as a replacement tablet (supplying both alogliptin and pioglitazone) in patients who are already being treated with alogliptin and pioglitazone given separately.
Maltese: Incresync jista' jintuża wkoll bħala pillola ta' sostituzzjoni (li tipprovdi kemm alogliptin kif ukoll pioglitazone) f'pazjenti li diġà jkunu qed jiġu kkurati b'alogliptin u pioglitazone mogħtija separatament.
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Maltese: Alogliptin inaqqas ukoll l-ammont tal-glukożju prodott mill-fwied, billi jżid il-livelli tal-insulina u jnaqqas il-livelli tal-ormon glucagon.
English: Incresync is a diabetes medicine containing the active substances alogliptin and pioglitazone.
Maltese: Incresync huwa mediċina għad-dijabete li fiha s-sustanzi attivi alogliptin u pioglitazone.
English: Both studies showed that the combination of active substances in Incresync could produce a small but clinically relevant improvement in HbA1c.
Maltese: Iż-żewġ studji wrew li l-kombinazzjoni tas-sustanzi attivi f'Incresync tista' tipproduċi titjib żgħir iżda klinikament rilevanti fl-HbA1c.
English: Pioglitazone is authorised in the EU as Actos and associated names.
Maltese: Pioglitazone huwa awtorizzat fl-UE bħala Actos u ismijiet assoċjati.
English: HbA1c levels give an indication of how well the blood glucose is controlled.
Maltese: Il-livelli tal-HbA1c jagħtu indikazzjoni ta' kemm ikun ikkontrollat tajjeb il-glukożju fid-demm.
English: Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: Dawn l-ormoni jintreħew wara ikla u jistimulaw il-frixa biex tipproduċi l-insulina.
English: Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete ta' tip 2 hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell tal-glukożju fid-demm jew meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effettiv.
English: Alogliptin is licensed in the EU as Vipidia.
Maltese: pioglitazone u metformin.
English: One of the studies compared the effects of alogliptin with placebo (a dummy treatment) when used as an add-on to existing treatment with pioglitazone (the same combination as in Incresync), with or without metformin or another diabetes medicine.
Maltese: • f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti b'pioglitazone waħdu, u li ma jistgħux jiġu kkurati b'metformin (mediċina oħra għad-dijabete);
English: • together with metformin, in patients who are not satisfactorily controlled with a combination of pioglitazone and metformin.
Maltese: • flimkien ma' metformin, f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti b'kombinazzjoni ta'
English: Relative risk (95% CI) vs. placebo
Maltese: Riskju relativ (95 % CI) vs. plaċebo
English: Gyömrői út 19-21 1103 Budapest HUNGARY
Maltese: Gyömrői út 19-21 1103 Budapest L-UNGERIJA
English: Manufacturer Gedeon Richter Plc.
Maltese: Manifattur Gedeon Richter Plc.
English: Date of first authorisation: 11 January 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 11 ta' Jannar 2017
English: Distributor: XXXXXXXXXXX
Maltese: XXXXXXXXXXX
English: • Ypsomed mylife Clickfine 29 to 31 gauge (diameter 0.25 - 0.33 mm) and 12, 10, 8 or 6 mm length
Maltese: • Ypsomed mylife Clickfine 29 sa 31 gejġ (dijametru 0.25 - 0.33 mm) u tul ta' 12, 10, 8 jew 6 mm
English: 1 Movymia cartridge 1 Movymia Pen
Maltese: 1 Movymia skartoċċ 1 Movymia Pen
English: EU/1/16/1161/001 [1 cartridge] EU/1/16/1161/002 [3 cartridges]
Maltese: EU/1/16/1161/001 [1 skartoċċ] EU/1/16/1161/002 [3 skrataċ]
English: Movymia is indicated in adults.
Maltese: Movymia huwa indikat fl-adulti.
English: EU/1/16/1161/001 [1 cartridge] EU/1/16/1161/002 [3 cartridges] EU/1/16/1161/003 [cartridge and pen pack]
Maltese: EU/1/16/1161/001 [1 skartoċċ] EU/1/16/1161/002 [3 skrataċ] EU/1/16/1161/003 [pakkett ta' skartoċċ u pinna]
English: Movymia is a biosimilar medicinal product.
Maltese: Movymia huwa prodott mediċinali bijoloġiku simili.
English: The following convention has been used for the classification of the adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (≥1/10,000 to
Maltese: Bħala klassifikazzjoni tar- reazzjonijiet avversi ġiet użata s-sistema li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), u rari(≥ 1/10,000 sa < 1/1,000).
English: Dizziness, headache, sciatica, syncope
Maltese: Sturdament, uġigħ ta' ras, xjatika, sinkope
English: EU/1/16/1161/003 [cartridge and pen pack]
Maltese: EU/1/16/1161/003 [pakkett ta' skartoċċ u pinna]
English: Do not use Movymia:
Maltese: Tużax Movymia:
English: Subcutaneous use {1x} SC
Maltese: Użu għal taħt il-ġilda {1x} SC
English: Movymia cartridge
Maltese: Movymia skartoċċ
English: At baseline, the postmenopausal women had a mean age of 61 years, mean lumbar spine BMD T score of −2.7, median prednisone equivalent dose of 7.5 mg/day, and 34% had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of −2.5, median prednisone equivalent dose of 10 mg/day, and 9% had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD T score of −2.2, median prednisone equivalent dose of 10 mg/day, and 24% had one or more radiographic vertebral fractures.
Maltese: Fil-linja bażi, in-nisa wara l-menopawża kellhom età medja ta' 61 sena, medja ta' BMD filparti lumbari ta' l-ispina b'valur T ta' -2.7, doża medja ekwivalenti għal 7.5 mg/jum ta' prednisone u 34 %, skond ir-radjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra; in-nisa qabel il-menopawża kellhom età medja ta' 37 sena, medja ta' BMD fil-parti lumbari ta' l-ispina b'valur T ta' -2.5, doża medja ekwivalenti għal 10 mg/jum ta' prednisone u 9 %, skond ir-radjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra; u l-irġiel kellhom età medja ta' 57 sena, medja ta' BMD fil-parti lumbari ta' l ispina b'valur T ta' -2.2, doża medja ekwivalenti għal 10 mg/jum ta' prednisone u 24 %, skond irradjografiji, kellhom ksur ta' wieħed jew ta' aktar vertebra.
English: Major non-vertebral fragility fractures c (hip, radius, humerus, ribs and pelvis)
Maltese: Ksur ta' fraġilità maġġuri mhux vertebrali (ġenbejn, radjus, omeru, kustilji u pelvis)
English: Legal manufacturer: Ypsomed AG Brunnmattstrasse 6 3401 Burgdorf Switzerland
Maltese: Ypsomed AG Brunnmattstrasse 6
English: 1,013 (74.5%) patients completed the 24-month follow-up.
Maltese: 1,013-il pazjenta (74.5 %) temmew l-24 xahar ta' segwitu.
English: The cumulative incidence of pooled clinical fractures (clinical vertebral and non vertebral fractures) was 4.8% in teriparatide and 9.8% in risedronate-treated patients, hazard ratio (95% CI) = 0.48 (0.32-0.74), p=0.0009.
Maltese: Linċidenza kumulattiva tal-ksur kliniku miġbur flimkien (ksur kliniku tal-vertebra u mhux tal-vertebrae) kienet 4.8 % fil-pazjenti ttrattati b'teriparatide u 9.8 % fil-pazjenti ttrattati b'risedronate, proporzjon ta' periklu (95 % CI) = 0.48 (0.32-0.74), p=0.0009.
English: 1 carton of Movymia cartridge (containing 1 cartridge) and 1 carton of Movymia Pen (containing 1 pen).
Maltese: Kartuna 1 ta' Movymia skartoċċ (li fiha skartoċċ 1) u kartuna 1 ta' Movymia Pen (li fiha pinna 1).
English: At baseline, the women had a mean age of 72.1 years and a median of 2 prevalent vertebral fractures; 57.9% of patients had received previous bisphosphonate therapy and 18.8% took concomitant glucocorticoids during the study.
Maltese: Fil-linja bażi, n-nisa kellhom età medja ta' 72.1 sena u medjan ta' 2 ksur prevalenti tal-vertebrae; 57.9 % tal-pazjenti kienu rċivew terapija preċedenti b'bisphosphonate u 18.8 % ħadu glukokortikojdi fl-istess waqt matul l-istudju.
English: Other medicines and Movymia
Maltese: Mediċini oħra u Movymia
English: There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on Bone Mineral Density (BMD) response.
Maltese: Ma kienx hemm evidenza ta' reazzjonijiet ta' sensittivita' eċċessiva, reazzjonijiet allerġiċi, effetti fuq calcium fis-serum, jew effetti fuq id-Densità Minerali tal-Għadam (BMD).
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in teriparatide- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), p<0.0001.
Maltese: Għall-dawk l-individwi li kellhom radjugrafs tas-sinsla tal-linja bażi u tas-segwitu, linċidenza ta' ksur vertebrali ġdid kienet 28/516 (5.4 %) fil-pazjenti ttrattati b'teriparatide u 64/533 (12.0 %) fil-pazjenti ttrattati b'risedronate, riskju relattiv (95 % CI) = 0.44 (0.29-0.68), p<0.