FrancophonIA/ELRC3.0 huggingface dataset:
English: The study showed that Kyprolis is effective at prolonging the time patients lived without their disease getting worse (progression-free survival): patients receiving Kyprolis with lenalidomide and dexamethasone lived on average for 26.3 months without their disease getting worse, compared with 17.6 months for patients receiving lenalidomide plus dexamethasone.
Maltese: L-istudju wera li Kyprolis huwa effikaċi biex itawwal iż-żmien li għexu l-pazjenti qabel ma l-marda tagħhom marret għall-agħar (sopravivenza mingħajr progressjoni): il-pazjenti li kienu qegħdin jirċievu Kyprolis ma' lenalidomide u dexamethasone għexu bħala medja għal 26.3 xhur mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 17.6 xhur għall-pazjenti li kienu qegħdin jirċievu lenalidomide flimkien ma' dexamethasone.
English: Kyprolis taken together with lenalidomide and dexamethasone has been compared with lenalidomide plus dexamethasone in one main study involving 792 patients with multiple myeloma whose disease had got worse after previous treatment.
Maltese: Kyprolis meħud flimkien ma' lenalidomide u dexamethasone tqabbel ma' lenalidomide flimkien ma' dexamethasone fi studju ewlieni wieħed li involva 792 pazjent b'majeloma multipla li l-marda tagħhom kienet marret għall-agħar wara kura preċedenti.
English: Kyprolis is available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Kyprolis jiġi bħala trab li jsir soluzzjoni għall-infużjoni (dripp) ġol-vina.
English: For the full list of side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: The study showed that the combination of Kyprolis and dexamethasone is more effective at improving progression-free survival than bortezomib and dexamethasone: patients receiving Kyprolis plus dexamethasone lived for an average of 18.7 months without their disease getting worse, compared with 9.4 months for patients receiving bortezomib and dexamethasone.
Maltese: Listudju wera li l-kombinazzjoni ta' Kyprolis u dexamethasone hija aktar effettiva fit-titjib tassopravivenza mingħajr progressjoni minn bortezomib u dexamethasone: il-pazjenti li kienu qegħdin jirċievu Kyprolis flimkien ma' dexamethasone għexu medja ta' 18.7 xhur mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 9.4 xhur għall-pazjenti li kienu qegħdin jirċievu bortezomib u dexamethasone.
English: What measures are being taken to ensure the safe and effective use of Kyprolis?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Kyprolis?
English: Another study in 929 multiple myeloma patients whose disease had got worse after previous treatment compared the combination of Kyprolis and dexamethasone with bortezomib and dexamethasone.
Maltese: Studju ieħor f'929 pazjent b'majeloma multipla li l-marda tagħhom marret għall-agħar wara kura preċedenti qabbel il-kombinazzjoni ta' Kyprolis u dexamethasone ma' bortezomib u dexamethasone.
English: How is Kyprolis used?
Maltese: Kif jaħdem Kyprolis?
English: Regarding safety, although side effects, including severe effects, were seen with treatment involving Kyprolis, these were considered acceptable and manageable.
Maltese: Rigward is-sigurtà, għalkemm bil-kura li tinvolvi Kyprolis dehru effetti sekondarji, inkluż effetti severi, dawn ġew ikkunsidrati aċċettabbli u maniġġabbli.
English: What benefits of Kyprolis have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Kyprolis li ħarġu mill-istudji?
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Maltese: Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
English: Via Isonzo, 71 04100 Latina Italy
Maltese: Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina Italy
English: CT13 9NJ United Kingdom200 mg/100ml Solution for Infusion
Maltese: CT13 9NJ United Kingdom200 mg/5ml Trab għal sospensjoni Użu orali
English: Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg, Luxembourg
Maltese: Kennedy L-1855 Luxembourg, Luxembourg
English: Boulevard de la Plaine 17 1050 Brussels Belgium200 mg/100ml Solution for Infusion
Maltese: Boulevard de la Plaine 17 1050 Brussels Belgium200 mg/5ml Trab għal sospensjoni Użu orali
English: Diflucan 100 mg
Maltese: Diflucan 100 mg 100 mg
English: Diflucan 150 mg
Maltese: Diflucan 150 mg 150 mg
English: Pfizer KFT 1123 Budapest Alkotás u. 53.
Maltese: 1123 Budapest Alkotás u. 53.
English: Suspension
Maltese: Diflucan suspensie
English: Pfizer KFT 1123 Budapest, Alkotás u. 53.
Maltese: 1123 Budapest, Alkotás u. 53.
English: Diflucan 50 mg/5 mlTrockensaft
Maltese: Diflucan 50 mg/5 ml - Trockensaft
English: Powder for Oral suspension
Maltese: Trab għal sospensjoni orali
English: Diflucan 50 mg
Maltese: Diflucan 50 mg 50 mg
English: Diflucan i.v.-100mg 100 mg/50 ml
Maltese: Diflucan i.v.100mg
English: Fluconazole Pfizer
Maltese: Fluconazole Pfizer 200 mg
English: Diflucan 2mg/ml
Maltese: Diflucan 2mg/ml 2 mg/ml
English: Diflucan 2 mg/ml
Maltese: Diflucan 2 mg/ml 2 mg/ml
English: 200 mg/100ml Solution for Infusion
Maltese: 100 mg/50ml Soluzzjoni għal infużjoni
English: Syrup
Maltese: Żvezja
English: Diflucan suspensie 200 200 mg/5ml
Maltese: Diflucan P.O .S. 200 mg/5ml
English: Infusion
Maltese: Mistura
English: The full EPAR for Cayston 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: It contains the active substance aztreonam.
Maltese: Fih is-sustanza attiva ażtreonam.
English: EPAR summary for the public aztreonam
Maltese: Sommarju tal-EPAR għall-pubbliku ażtreonam
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cayston can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The third study showed that Cayston compared favourably with the comparator antibiotic: after four weeks of treatment, the increase in FEV1 adjusted for age, height and sex was 8.35% with Cayston and 0.55% with the comparator; after three treatment cycles, the increase with Cayston was 2.05% compared with a decrease of 0.66% with the comparator.
Maltese: It-tielet studju wera li Cayston tqabbel b'mod favorevoli mal-antibijotiku komparatur: wara erba' ġimgħat ta' kura, iż-żieda fil-FEV1 aġġustat għall-età, tul u sess kienet ta' 8.35% b'Cayston u 0.55% bil-komparatur; wara tliet ċikli ta' kura, iż-żieda b'Cayston kienet 2.05% meta mqabbla ma' tnaqqis ta' 0.66% bil-komparatur.
English: The active substance in Cayston, aztreonam, is an antibiotic that belongs to the group ‘beta-lactams'.
Maltese: Is-sustanza attiva f'Cayston, l-ażtreonam, hija antibijotiku li tappartieni lill-grupp tal-‘beta-lattami'.
English: This document is a summary of the European public assessment report (EPAR) for Cayston.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Cayston.
English: A third main study involving 268 patients (including 59 children from six to 17 years of age) compared Cayston with another inhaled antibiotic (tobramycin nebuliser solution).
Maltese: It-tielet studju ewlieni, li involva 268 pazjent (inkluż 59 tifel/tifla ta' età bejn is-sitt snin u s-17-il sena) qabbel Cayston ma' antibijotiku ieħor li jittieħed man-nifs (soluzzjoni nebulizzatur ta' tobramycin).
English: Why has Cayston been approved?
Maltese: Għaliex ġie approvat Cayston?
English: Because the number of patients with bacterial lung infection in cystic fibrosis is low, the disease is considered ‘rare', and Cayston was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2004.
Maltese: Billi l-għadd ta' pazjenti li jbatu min infezzjoni batterika fil-pulmun mill-fibrożi ċistika huwa baxx, ilmarda hija meqjusa ‘rari' u fil-21 ta' Ġunju 2004 Cayston ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata kontra mard rari).
English: Cayston was more effective than placebo at suppressing lung infection caused by P. aeruginosa bacteria in patients with cystic fibrosis.
Maltese: Cayston kien aktar effikaċi mill-plaċebo fis-soppressjoni tal-infezzjoni pulmonari kkaġunata minn batterji P. aeruginosa f'pazjenti li jbatu minn fibrożi ċistika.
English: What is Cayston?
Maltese: X'inhu Cayston?
English: Cayston was compared with placebo (a dummy treatment) in two main studies involving a total of 375 patients with cystic fibrosis who had long-term lung infection due to P.aeruginosa, most of whom were adults.
Maltese: Cayston tqabbel ma' plaċebo (trattament finta) f'żewġ studji ewlenin li involvew total ta' 375 pazjent li jbatu minn fibrożi ċistika li kellhom infezzjoni fil-pulmun għal perjodu ta' żmien twil minħabba P.aeruginosa, li l-maġġoranza tagħhom kienu adulti.
English: The most common side effects with Cayston (seen in more than 1 patient in 10) are wheezing, cough, pharyngolaryngeal pain (pain in the throat and voice box), nasal congestion (blocked nose), dyspnoea (difficulty breathing) and fever.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Cayston (li dehru f'aktar minn pazjent 1 minn 10) kienu tħarħir fin-nifs, sogħla, uġigħ faringolarinġeali (uġigħ fil-gerżuma u fil-larinġi), konġestjoni nażali (imnieħer misdud), dispnea (diffiklutà fit-teħid tan-nifs) u deni.
English: The CHMP concluded that there was an unmet medical need for new antibiotics in patients with cystic fibrosis, since many of these patients have already developed resistance to other antibiotics by the time they reach adulthood, and because P. aeruginosa lung infections are a cause of severe health problems in patients with cystic fibrosis.
Maltese: Is-CHMP ikkonkluda li kien hemm ħtieġa medika bla preċedenti ta' antibijotiċi ġodda f'pazjenti li jbatu minn fibrożi ċistika, billi ħafna minn dawn il-pazjenti kienu diġà żviluppaw reżistenza għal antibijotiċi oħra saż-żmien li fih ikunu saru adulti, u billi l-infezzjonijiet pulmonari P. aeruginosa huma kkawżati minn problemi gravi fis-saħħa fil-pazjenti li jbatu minn fibrożi ċistika.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cayston on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Cayston valida fl-Unjoni Ewropea kollha fil-21 ta' Settembru 2009.
English: It works by attaching to proteins on the surface of the P. aeruginosa bacteria.
Maltese: Din taħdem billi teħel ma' ċerti tipi ta' proteina preżenti fuq il-wiċċ tal-batterji P. aeruginosa.
English: What is the risk associated with Cayston?
Maltese: Għal xiex jintuża Cayston?
English: In patients with cystic fibrosis, P. aeruginosa infections usually start in the first 10 years of life and can cause long-term lung problems.
Maltese: Fil-pazjenti li jbatu minn fibrożi ċistika, normalment l-infezzjonijiet P. aeruginosa jibdew fl-ewwel 10 snin tal-ħajja u jistgħu jikkawżaw problemi pulmonari kroniċi.
English: How has Cayston been studied?
Maltese: Kif ġie studjat Cayston?
English: The CHMP decided that Cayston's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Cayston huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fissuq.
English: In cystic fibrosis these secretions become thick, blocking the airways and the flow of digestive juices.
Maltese: Fil-fibrożi ċistika, dawn is-sekrezzjonijiet isiru ħoxnin, u jimblokkaw il-passaġġi tal-arja u l-flussi tal-meraq diġestiv.
English: In Cayston, aztreonam is available as a ‘lysine salt', which makes it possible for the antibiotic to be breathed directly into the lungs without causing irritation.
Maltese: F'Cayston, lażtreonam huwa disponibbli bħala ‘melħ ta' lisina', li jagħmilha possibbli għall-antibijotiku li jinġibed direttament man-nifs ġewwa l-pulmuni mingħajr ma jikkawża irritazzjonijiet.
English: The main measure of effectiveness was based on improvements in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: Ilkejl ewlieni tal-effikaċja kien ibbażata fuq it-titjib fil-volumi espiratorji furzati tal-pazjenti (FEV1, ilvolum massimu ta' arja li persuna tista' timbotta 'l barra f'sekonda waħda).
English: Cayston is a powder and solvent that are made up into a nebuliser solution.
Maltese: Cayston jikkonsisti fi trab u solvent li jitħalltu flimkien sabiex jiffurmaw soluzzjoni għal nebulizzatur.
English: Other information about Cayston:
Maltese: Aktar tagħrif dwar Cayston:
English: Date of first authorisation: 4 January 2007 Date of latest renewal: 21 November 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 4 ta' Jannar 2007 Data tal-aħħar tiġdid: 21 Novembru 2011
English: Tablet
Maltese: il pillola.
English: Addenda Pharma S.r.l., Tel: +39-06-9139 3303 addendapharma@legalmail.it
Maltese: Addenda Pharma S.r.l., Tel: +39-06-9139 3303
English: ADROVANCE 70 mg/2,800 IU tablets EU/1/06/364/001 - 2 tablets
Maltese: ADROVANCE 70 mg/2800 IU pilloli EU/1/06/364/001 - 2 pilloli
English: MSD Α.Φ.Β.Ε.Ε Τηλ: +30 210 98 97 300 dpoc_greece@merck.com
Maltese: Τηλ: + 30-210 98 97 300 dpoc_greece@merck.com
English: Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
Maltese: Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com
English: (bisphosphonate class adverse reaction)
Maltese: (reazzjoni avversa tal-klassi tal-bisphosphonate)
English: Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Maltese: Olestra, żjut minerali, orlistat, u sekwestranti tal-aċidi biljari (eż. cholestyramine, colestipol) jistgħu jimpedixxu l-assorbiment ta' vitamina D.
English: What is ADROVANCE?
Maltese: X'inhu ADROVANCE?
English: The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss medju, esklussivament mill-għadam, huwa ta' l-anqas 28 litru fil-bnedmin.
English: Merck Sharp & Dohme BV Tel: +31 (0)800 99 99 000 (+31 (0)23 5153153) medicalinfo.nl@merck.com
Maltese: Merck Sharp & Dohme BV Tel: +31 (0)800 99 99 000 (+31 (0)23
English: Eλλάδα
Maltese: IU/kuljum.
English: The mean increases from baseline in lumbar spine BMD at one year were 5.1 % (95 % CI: 4.8, 5.4 %) in the 70 mg once-weekly group and 5.4 % (95 % CI: 5.0, 5.8 %) in the 10 mg daily group.
Maltese: (95 % CI: 4.8, 5.4 %) fil-grupp ta' 70 mg darba fil-ġimgħa u 5.4 % (95 % CI: 5.0, 5.8 %) fil-grupp ta'
English: However, the incidences of decreases in serum calcium to < 8.0 mg/dl (2.0 mmol/l) and serum phosphate to  2.0 mg/dl (0.65 mmol/l) were similar in both treatment groups.
Maltese: Madankollu, l-inċidenzi ta' tnaqqis tal-kalċju fis-serum għal < 8.0 mg/dl (2.0 mmol/l) u l-fosfat fis serum għal ≤ 2.0 mg/dl (0.65 mmol/l) kienu simili fiż-żewġ gruppi ta' kura.
English: EU/1/06/364/001 (2 tablets) EU/1/06/364/002 (4 tablets) EU/1/06/364/003 (6 tablets) EU/1/06/364/004 (12 tablets)
Maltese: EU/1/06/364/001 (2 pilloli) EU/1/06/364/002 (4 pilloli) EU/1/06/364/003 (6 pilloli) EU/1/06/364/004 (12-il pillola)
English: Colloidal silicon dioxide Magnesium stearate (E572) Butylhydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Maltese: Modified starch (maize) Sodium aluminium silicate (E554)
English: †, pruritus Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: Rari raxx b'fotosensittività, reazzjonijiet severi tal-ġilda li jinkludu s-sindrome ta' Stevens-Johnson u nekrolisi epidermika tossika‡
English: BLISTER FOR ADROVANCE 70 mg/2,800 IU
Maltese: FOLJA GĦAL ADROVANCE 70 mg/2,800 IU
English: BLISTER FOR ADROVANCE 70 mg/5,600 IU
Maltese: FOLJA GĦAL ADROVANCE 70 mg/5,600 IU
English: ADROVANCE 70 mg/5,600 IU tablets
Maltese: ADROVANCE 70 mg/5600 IU pilloli
English: ADROVANCE 70 mg/5,600 IU tablets EU/1/06/364/006 - 2 tablets EU/1/06/364/007 - 4 tablets EU/1/06/364/008 - 12 tablets
Maltese: ADROVANCE 70 mg/5600 IU pilloli EU/1/06/364/006 - 2 pilloli EU/1/06/364/007 - 4 pilloli EU/1/06/364/008 - 12-il pillola
English: The percentage of patients with vitamin D deficiency was 0.3 % in the Vitamin D3 2,800 group vs. zero in the Vitamin D3 5,600 group.
Maltese: Ilperċentwal ta' pazjenti b'insuffiċjenza ta' vitamina D kien ta' 0.3% fil-grupp tal-Vitamina D3 2,800 vs. żero fil-grupp tal-Vitamina D3 5,600.
English: The alendronate component in the ADROVANCE (70 mg/2,800 IU) combination tablet and the ADROVANCE (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Maltese: Il-komponent alendronate fil-pillola kombinata ADROVANCE (70 mg/2800 IU) u fil-pillola kombinata ADROVANCE (70 mg/5600 IU) huwa bijoekwivalenti għal pillola ta' 70 mg alendronate.
English: EU/1/06/364/006 (2 tablets) EU/1/06/364/007 (4 tablets) EU/1/06/364/008 (12 tablets)
Maltese: EU/1/06/364/006 (2 pilloli) EU/1/06/364/007 (4 pilloli) EU/1/06/364/008 (12-il pillola)
English: Excipients with known effect Each tablet contains 63 mg lactose (as lactose anhydrous) and 16 mg sucrose.
Maltese: Kull pillola fiha 62 mg lactose (bħala lactose anhydrous) u 16-il mg sucrose.
English: Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years.
Maltese: Alendronate sodium ġie studjat f'numru żgħir ta' pazjenti b'osteogenesis imperfecta taħt l-età ta' 18
English: EU/1/06/364/003 - 6 tablets
Maltese: EU/1/06/364/003 - 6 pilloli
English: Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5 and section 4.8).
Maltese: Xorb ieħor (li jinkludi l-ilma minerali), ikel u xi prodotti mediċinali oħrajn x'aktarx inaqqsu lassorbiment ta' alendronate (ara sezzjoni 4.5 u sezzjoni 4.8).
English: The content of vitamin D in ADROVANCE is not suitable for correction of vitamin D deficiency.
Maltese: Il-kontenut ta' vitamina D f'ADROVANCE mhix adattata għal korrezzjoni ta' defiċjenza tal-vitamina D.
English: Patients in the Vitamin D3 2,800 group received ADROVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received ADROVANCE (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Maltese: Vitamina D3 2,800 irċevew ADROVANCE (70 mg/2,800 IU) (n=299) u pazjenti fil-grupp talVitamina D3 5,600 irċevew ADROVANCE (70 mg/2,800 IU) kif ukoll 2,800 IU vitamina D3
English: How to store ADROVANCE
Maltese: Studji dwar ADROVANCE
English: ADROVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol
Maltese: ADROVANCE 70 mg/5600 IU pilloli alendronic acid/colecalciferol
English: EU/1/06/364/002 - 4 tablets
Maltese: EU/1/06/364/002 - 4 pilloli
English: The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with ADROVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Maltese: Il-perċentwali ta' pazjenti b'insuffiċjenza ta' vitamina D (25-hydroxyvitamin D fis serum < 37.5 nmol/l [< 15 ng/ml]) kien sinifikattivament imnaqqas bi 62.5 % b'ADROVANCE (70 mg/2800 IU) kontra alendronate biss (12 % kontra 32 %, rispettivament), matul ġimgħa 15.
English: MSD Polska Sp.z o.o.
Maltese: MSD Danmark ApS
English: It is likely that certain medicines or food additives may prevent the vitamin D in ADROVANCE from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
Maltese: Jista' jkun li ċertu mediċini jew addittivi ta' l-ikel jimpedixxu l-vitamina D f'ADROVANCE milli tidħol f'ġismek, u dawn jinkludu sostituti artifiċjali tax-xaħam, żjut minerali, il-mediċina orlistat li tnaqqas il-piż, u l-mediċini li jnaqqsu l-kolesterol, cholestyramine u colestipol.
English: • FIT 1: A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture.
Maltese: • FIT 1: Studju ta' tliet snin fuq 2,027 pazjenti li kellhom ta' l-anqas frattura (ta' kompressjoni) vertebrali waħda fil-linja bażi ta' riferiment.
English: The mean maximal serum concentration (Cmax) of vitamin D3 was 12.2 ng/ml and the median time to maximal serum concentration (Tmax) was 10.6 hours.
Maltese: 12.2 ng/ml, u l-ħin medjan għal konċentrazzjoni massima fis-serum (Tmax) kien ta' 10.6 sigħat.
English: Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations (SD) below the mean value of a normal young population or as a previous fragility fracture, irrespective of BMD.
Maltese: L-osteoporożi hija definita bħala densità minerali ta' l-għadam (BMD) tas-sinsla jew tal-ġenbejn 2.5 b'devjazzjonijiet min-normal (SD) l-isfel mill-valur medju ta' popolazzjoni normali żagħżugħa jew bħala frattura ta' fraġilità preċedenti, irrespetivament mill-BMD.
English: In the initial efficacy studies, the mean BMD increases with alendronate 10 mg/day relative to placebo at three years were 8.8 %, 5.9 % and 7.8 % at the spine, femoral neck and trochanter, respectively.
Maltese: Fl-istudji ta' l-effikaċja fil-bidu, żjidiet fil-BMD medja b' alendronate 10 mg/kuljum relattivament ma' plaċebo fi żmien tliet snin kienu 8.8 %, 5.9 % u 7.8 % fis-sinsla, fl-għonq femurali u fittrochanter, rispettivament.
English: ADROVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol
Maltese: ADROVANCE 70 mg/2800 IU pilloli alendronic acid/colecalciferol
English: 2031 BN, Haarlem The Netherlands
Maltese: 2031 BN, Haarlem Il-Pajjiżi l-Baxxi
English: ADROVANCE 70 mg/2,800 IU tablets
Maltese: ADROVANCE 70 mg/2800 IU pilloli
English: Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Merck Sharp & Dohme B.V.
English: Rare oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)
Maltese: Rari tidjiq esofagali*, ulċerazzjoni orofarinġali*, PUBs (perforazzjonijiet, ulċeri, fsada) gastrointestinali finnaħa ta' fuq§
English: The effect of the lower dose of ADROVANCE (alendronate 70 mg/vitamin D3 2,800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic postmenopausal women (serum 25-hydroxyvitamin D at baseline: mean, 56 nmol/l [22.3 ng/ml]; range, 22.5-225 nmol/l [9-90 ng/ml]).
Maltese: IU) fuq l-istat tal-vitamina D kien muri fi studju multinazzjonali ta' 15-il ġimgħa li rreġistra 682 nisa ta' wara lmenopawża bl-osteoporożi (25-hydroxyvitamin D fis-serum fil-linja bażi: medja, 56 nmol/l [22.3 ng/ml]; firxa, 22.5-225 nmol/l [9-90 ng/ml]).
English: After 24-weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher in the Vitamin D3 5,600 group (69 nmol/l [27.6 ng/ml]) than in the Vitamin D3 2,800 group (64 nmol/l [25.5 ng/ml]).
Maltese: Wara 24 ġimgħa ta' trattament, il-livelli medji ta' 25-hydroxyvitamin D fis-serum kienu ferm ogħla fil grupp tal-Vitamina D3 5,600 (69 nmol/l [27.6 ng/ml]) milli fil-grupp tal-Vitamina D3 2,800 (64 nmol/l [25.5 ng/ml]).
English: Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Maltese: Antikonvulsanti, cimetidine u thiazides jistgħu jżiedu lkataboliżmu ta' vitamina D.
English: Other medicines and ADROVANCE
Maltese: Mediċini oħra u ADROVANCE
English: ; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Maltese: Rari ħafna osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa tal-klassi bisphosphonate)
English: EU/1/06/364/004 - 12 tablets
Maltese: EU/1/06/364/004 - 12-il pillola
English: ADROVANCE contains lactose and sucrose.
Maltese: ADROVANCE fih il-lactose u s-sucrose.