FrancophonIA/ELRC3.0 huggingface dataset:
English: The bioavailability of the 5,600 IU vitamin D3 in VANTAVO is similar to 5,600 IU vitamin D3 administered alone.
Maltese: Il-bijodisponibiltà tal-5600 IU vitamina D3 f'VANTAVO hija simili għal 5600
English: The mean BMD increases were 2.3 % and 2.9 % at the femoral neck and 2.9 % and 3.1 % at the total hip in the 70 mg once weekly and 10 mg daily groups, respectively.
Maltese: Iż-żjidiet medja fil-BMD kienu 2.3 % u 2.9 % fl-għonq tal-femora u 2.9 % u 3.1 % flgħadam tal-ġenbejn totali fil-gruppi ta' 70 mg darba fil-ġimgħa u 10 mg kuljum, rispettivament.
English: Circulating vitamin D3 is bound to vitamin D-binding protein.
Maltese: Il-vitamina D3 li tkun qed tiċirkola hija marbuta mal-proteina tal-vitamina D.
English: The percentage of patients with vitamin D deficiency (serum 25-hydroxyvitamin D  22.5 nmol/l [ 9 ng/ml]) was significantly reduced by 92 % with VANTAVO (70 mg/2800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Maltese: Il-perċentwali ta' pazjenti b'insuffiċjenza ta' vitamina D (25-hydroxyvitamin D fis-serum < 22.5 nmol/l [< 9 ng/ml]) kien sinifikattivament imnaqqas bi 92 % b'VANTAVO (70 mg/2800 IU) kontra alendronate biss (1 % kontra 13 %, rispettivament).
English: Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Maltese: Il-bidla għal ormon mobilizzanti tal-kalċju attiv 1,25-dihydroxyvitamin D3 (calcitriol) fil-kilwa hija strettament irregolata.
English: BLISTER FOR VANTAVO 70 mg/2,800 IU
Maltese: KARTUNA GĦAL VANTAVO 70 mg/2800 IU
English: In addition, a statistically significant reduction was found in the incidence of hip fractures (1.1 % vs. 2.2 %, a reduction of
Maltese: Barra minn hekk, tnaqqis statistikament sinifikattiv instab fl-inċidenzi ta' fratturi tal-għadam tal-ġenbejn (1.1 % kontra 2.2 %, tnaqqis ta' 51 %).
English: There was a 48 % reduction (alendronate 3.2 % vs placebo 6.2 %) in the proportion of patients treated with alendronate experiencing one or more vertebral fractures relative to those treated with placebo.
Maltese: Kien hemm ukoll tnaqqis ta' 48 % (alendronate 3.2 % kontra plaċebo 6.2 %) fil-proporzjon ta' pazjenti li kellhom waħda jew aktar fratturi vertebrali trattati b'alendronate relattivament ma' dawk ittrattati bi plaċebo.
English: However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption) (see section 4.8).
Maltese: Madankollu, kien hemm rapporti rari ta' ipokalċemia mhux sintomatika, li xi drabi kienet serja u ta' spiss ġrat f'pazjenti b'kundizzjonijiet li jippredisponu (eż. ipoparatirojdiżmu, defiċjenza tal-vitamina D u malassorbiment tal-kalċju) (ara sezzjoni 4.8).
English: It is likely that certain medicines or food additives may prevent the vitamin D in VANTAVO 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 tal-ikel jimpedixxu l-vitamina D f'VANTAVO milli tidħol f'ġismek, u dawn jinkludu sostituti artifiċjali tax-xaħam, żjut minerali, il-mediċina orlistat għat-telf talpiż u l-mediċini li jnaqqsu l-kolesterol, cholestyramine u colestipol.
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 tal-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 this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37 % of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0 % vs. placebo 2.2 %, a reduction of 56 %) and in the incidence of  1 vertebral fracture (2.9 % vs. 5.8 %, a reduction of 50 %).
Maltese: F'dan l-istudju, differenza sinifikattiva kienet osservata flanaliżi ta' sottogrupp ta' nisa osteoporotiċi (37 % tal-popolazzjoni globali li jikkorispondu maddefinizzjoni ta' osteoporożi) fl-inċidenza ta' fratturi tal-għadam tal-ġenbejn (alendronate 1.0 % kontra plaċebo 2.2 %, tnaqqis ta' 56 %) u fl-inċidenza ta' ≥1 frattura vertebrali (2.9 % kontra 5.8 %, tnaqqis ta' 50 %).
English: Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Maltese: Għaldaqstant, xi akkumulazzjoni akbar ta' alendronate fl-għadam tista' tkun mistennija f'pazjenti b'funzjoni renali mxekkla (ara sezzjoni 4.2).
English: A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.
Maltese: Perċentwali żgħir ta' vitamina D3 issirilha glucuronidation qabel l-eliminazzjoni.
English: Marketing Authorisation Holder and Manufacturer Merck Sharp & Dohme B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Merck Sharp & Dohme B.V.
English: insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with VANTAVO (70 mg/2800 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'VANTAVO (70 mg/2800 IU) kontra alendronate biss (12 % kontra 32 %, rispettivament), matul ġimgħa 15.
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: Il-konċentrazzjoni massima medja fis-serum (Cmax) ta' vitamina D3 kienet 12.2 ng/ml, u l-ħin medjan għal konċentrazzjoni massima fis-serum (Tmax) kienet ta' 10.6 sigħat.
English: VANTAVO tablet whole with a full glass of water only (not mineral water) (not less than
Maltese: VANTAVO tiegħek sħiħa ma' tazza mimlija ilma (mhux ilma minerali) (mhux inqas minn
English: The effect of the lower dose of VANTAVO (alendronate 70 mg/vitamin D3 2800 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 talvitamina 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: In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 % and 10 %, respectively, of patients taking alendronate 10 mg/day versus approximately 12 % and 3 % of those taking placebo.
Maltese: Fi studji kliniċi, tnaqqis mingħajr sintomi, ħafif u temporanju fil-livelli tal-kalċju u l-fosfat fis-serum kienu osservati f'madwar18 % u 10 %, rispettivament, ta' pazjenti li kienu qed jieħdu alendronate 10 mg/kuljum kontra bejn wieħed u ieħor 12 % u 3 % ta' dawk li kienu qed jieħdu plaċebo.
English: The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Maltese: Il-half-life terminali fil-bnedmin hija meqjusa li taqbez l-għaxar snin, u tirrifletti ħelsien minn ġol-iskeletru.
English: VANTAVO 70 mg/2,800 IU tablets
Maltese: VANTAVO 70 mg/2800 IU pilloli
English: VANTAVO contains lactose and sucrose.
Maltese: TA' EĊĊIPJENTI Fih ukoll: lactose u sucrose.
English: The mean half-life of vitamin D3 in the serum following an oral dose of VANTAVO (70 mg/2800 IU) is approximately 24 hours.
Maltese: Il-half-life medja ta' vitamina D3 fis-serum wara doża orali ta' VANTAVO (70 mg/2800
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 tal-anqas frattura (ta' kompressjoni) vertebrali waħda fil-linja bażi ta' riferiment.
English: ; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Maltese: Rari osteonekrożi tax-xedaq‡§; ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk (reazzjoni avversa tal-klassi tal-bisphosphonate)
English: Pharmacokinetic properties
Maltese: GĦAMLA FARMAĊEWTIKA
English: EU/1/09/572/002 - 4 tablets
Maltese: EU/1/09/572/007 - 4 pilloli
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 tal-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 fit-trochanter, rispettivament.
English: FIT consisted of two placebo-controlled studies using alendronate daily (5 mg daily for two years and 10 mg daily for either one or two additional years):
Maltese: FIT ikkonsista f'żewġ studji kontrollati bi plaċebo fejn intuża alendronate kuljum (5 mg għal sentejn u 10 mg kuljum għal sena jew sentejn addizzjonali):
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bisphosphonates, combinations, ATC code: M05BB03
Maltese: Mediċini għall-kura ta' mard tal-għadam, kombinazzjonijiet ta' bisphosphonates, Kodiċi ATC:
English: Each VANTAVO 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3)
Maltese: VANTAVO 70 mg/5600 IU pilloli Kull pillola fiha 70 mg alendronic acid (bħala sodium trihydrate), u 140 mikrogramma (5600
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: VANTAVO 70 mg/2800 IU tablets alendronic acid /colecalciferol
Maltese: VANTAVO 70 mg/2800 IU pilloli alendronic acid/colecalciferol
English: In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20 % to 44 %).
Maltese: F'suġġetti b'saħħithom prednisolone mogħti oralment (20 mg tliet darbiet kuljum għal hamest ijiem) ma għamilx bidla klinikament sinifikattiva fil-bijodisponibiltà orali ta' alendronate (żjieda medja tvarja minn 20 % sa 44 %).
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' kura, il-livelli medji ta' 25-hydroxyvitamin D fis-serum kienu ferm ogħla fil-grupp tal-Vitamina D3 5600 (69 nmol/l [27.6 ng/ml]) milli fil-grupp tal-Vitamina D3 2800 (64 nmol/l [25.5 ng/ml]).
English: VANTAVO 70 mg/5600 IU tablets alendronic acid /colecalciferol
Maltese: VANTAVO 70 mg/5600 IU pilloli alendronic acid/colecalciferol
English: In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the VANTAVO (70 mg/2800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70).
Maltese: F'dan l-istudju, livelli medji ta' 25-hydroxyvitamin D f'pazjenti b'insuffiċjenza ta' vitamina D fil-linja bażi ta' riferiment (25- hydroxyvitamin D, 22.5 għal 37.5 nmol/l [9 għal < 15 ng/ml]) żdiedu minn 30 nmol/l (12.1 ng/ml) għal 40 nmol/l (15.
English: Each VANTAVO 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Maltese: VANTAVO 70 mg/2800 IU pilloli Kull pillola fiha 70 mg alendronic acid (bħala sodium trihydrate), u 70 mikrogramma (2800 IU)
English: The bone formed during treatment with alendronate is of normal quality.
Maltese: L-għadam iffurmat waqt trattament b'alendronate huwa ta' kwalità normali.
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with VANTAVO.
Maltese: F'pazjenti b'dawn il-kundizzjonijiet, il-kalċju fis-serum u sintomi ta' ipokalċemija għandhom jiġu monitorjati waqt terapija b'VANTAVO.
English: VANTAVO 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Maltese: VANTAVO 70 mg/2800 IU pilloli jiġu f'pakketti li fihom 2, 4, 6, jew 12-il pillola.
English: In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate.
Maltese: Fi studji kliniċi ma kienx hemm differenza fil-profili tal-effikaċja jew tas-sigurtà ta' alendronate b'rabta mal-età.
English: 70 mg/2800 IU tablets alendronic acid/colecalciferol
Maltese: 70 mg/2800 UI pilloli alendronic acid/colecalciferol
English: • mouth ulcers.
Maltese: • ulċeri fil-ħalq.
English: The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).
Maltese: L-effetti ta' alendronate fuq il-massa tal-għadma u l-inċidenza ta' fratturi f'nisa wara l-menopawża kienu eżaminati f'żewġ studji tal-effikaċja fil-bidu ta' disinn identiku (n=994) kif ukoll fil-Fracture Intervention Trial (FIT: n=6,459).
English: The content of vitamin D in VANTAVO is not suitable for correction of vitamin D deficiency.
Maltese: Il-kontenut ta' vitamina D f'VANTAVO mhix adattata għal korrezzjoni ta' defiċjenza tal-vitamina D.
English: Vitamin D3 is required for normal bone formation.
Maltese: Vitamin D3 hi meħtieġa għal formazzjoni normali tal-għadam.
English: 70 mg/5600 IU tablets alendronic acid/colecalciferol
Maltese: 70 mg/5600 UI pilloli alendronic acid/colecalciferol
English: • joint swelling,
Maltese: • għandek kanċer,
English: While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8).
Maltese: Waqt li l-ebda żjieda fir-riskju ma kienet osservata fi provi kliniċi estensivi b'alendronate, kien hemm rapporti (ta' wara t-tqegħid fis-suq) rari ta' ulċeri gastriċi u duwodenali, li xi wħud minnhom kienu serji u bil-kumplikazzjonijiet (ara sezzjoni 4.8).
English: The therapeutic equivalence of alendronate once weekly 70 mg (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis.
Maltese: L-ekwivalenza terapewtika ta' alendronate 70 mg (n=519) mogħti darba fil-ġimgħa u alendronate 10 mg kuljum (n=370) kienet murija fi studju ta' sena f'ċentri multipli fuq nisa wara l-menopawża blosteoporożi.
English: Children and adolescents VANTAVO should not be given to children and adolescents less than 18 years of age.
Maltese: Tfal u adolexxenti VANTAVO ma għandux jingħata lil tfal u adolexxenti li għandhom anqas minn 18-il sena.
English: Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/day.
Maltese: Ma ġietx dokumentata waqt terapija kronika f'adulti li huma ġeneralment b'saħħithom tossiċità bilvitamina D f'doża ta' anqas minn 10,000
English: • taste disturbance.
Maltese: • disturb fit-togħma.
English: Uncommon eye inflammation (uveitis, scleritis, or episcleritis)
Maltese: Mhux komuni infjammazzjoni fl-għajn (uveite, sklerite jew episklerite)
English: EU/1/09/572/004 - 12 tablets
Maltese: EU/1/09/572/008 - 12-il pillola
English: Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Maltese: Alendronate jappartjeni għal grupp ta' mediċini mhux ormonali li jissejħu bisphosphonates.
English: After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the VANTAVO (70 mg/2800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
Maltese: Wara 15-il ġimgħa ta' trattament, il-livelli medji ta' 25hydroxyvitamin D fis-serum kienu sinifikattivament ogħla (26 %) fil-grupp VANTAVO (70 mg/2800 IU) (56 nmol/l [23 ng/ml]) milli fil-grupp ta' alendronate biss (46 nmol/l [18.2 ng/ml]).
English: 5 How to store VANTAVO Contents of the pack and other information
Maltese: Kif taħżen VANTAVO Kontenut tal-pakkett u informazzjoni oħra
English: In severe cases, deficiency results in secondary hyperparathyroidism, hypophosphataemia, proximal muscle weakness and osteomalacia, further increasing the risk of falls and fractures in osteoporotic individuals.
Maltese: F'każijiet serji, id-defiċjenza tirriżulta f'iperparatirojdiżmu sekondarju, ipofosfatemija, dgħjufija tal-muskoli prossimali u osteomalaċja, li tkompli żżid ir-riskju ta' waqgħat u fratturi f'individwi osteoporotiċi.
English: However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
Maltese: Madankollu, hemm riskju teoretiku ta' ħsara għall-fetu, il-biċċa l-kbira skelettrika, jekk mara tinqabad tqila wara li tkun temmet kors ta' terapija b'bisphosphonate.
English: VANTAVO is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Maltese: VANTAVO huwa pillola li fiha ż-żewġ sustanzi attivi, alendronic acid (magħruf b'mod komuni bħala alendronate) u colecalciferol magħruf bħala vitamina
English: No additional adverse reactions have been identified for the combination of alendronate and colecalciferol.
Maltese: L-ebda reazzjoni avversa addizzjonali ma ġiet identifikata għall-kombinazzjoni ta' alendronate u colecalciferol.
English: VANTAVO 70 mg/2800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
Maltese: VANTAVO 70 mg/2800 IU pilloli jiġu bħala pilloli modifikati f'għamla ta' kapsuli, ta' lewn bajdani jew bojod jagħtu fil-griż immarkati b' kontorn ta' immaġni ta' għadma fuq naħa u '710' fuq in-naħa loħra.
English: • FIT 2: A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture.
Maltese: • FIT 2: Studju ta' erba' snin fuq 4,432 pazjenti b'massa tal-għadam baxx imma mingħajr fratturi vertebrali fil-linja bażi ta' riferiment.
English: and cumulative dose
Maltese: U KWANTITATTIVA
English: The mean maximal serum concentration (Cmax) of vitamin D3 was 5.9 ng/ml, and the median time to maximal serum concentration (Tmax) was 12 hours.
Maltese: Il-konċentrazzjoni massima medja fis-serum (Cmax) ta' vitamina D3 kienet 5.9 ng/ml, u l-ħin medjan għal konċentrazzjoni massima fis-serum (Tmax) kienet ta' 12-il siegħa.
English: What is VANTAVO?
Maltese: X'inhu VANTAVO?
English: In both cases, the excreted radioactivity was almost exclusively as metabolites of the parent.
Maltese: Fiż-żewġ każijiet, ir-radjuattività eliminata kienet kważi esklusivament bħala metaboliti tal-ġenitur.
English: Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 140 micrograms (5600 IU) colecalciferol (vitamin D3.
Maltese: Kull pillola fiha 70 mg ta' alendronic acid (bħala sodium trihydrate) u 140 mikrogramma (5600
English: Continue your morning activities.
Maltese: Issokta bl-attivitajiet ta' filgħodu tiegħek.
English: In healthy adult subjects (males and females), following administration of VANTAVO 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Maltese: Wara l-għoti ta' VANTAVO 70 mg/5600 IU pilloli f'suġġetti adulti b'saħħithom (irġiel u nisa) wara sawma tul il-lejl u sagħtejn qabel ikla, l-erja medja taħt il-kurva tal-konċentrazzjoni tas-serum mal-ħin (AUC0-80 hrs) għal vitamina D3 (mhux aġġustata għal-livelli ta' vitamina D3 endoġena) kienet ta' 490.2 ng•hr/ml.
English: Medicines for fits (seizures) (like phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.
Maltese: Mediċini għall-aċċessjonijiet (attakki) (bħal phenytoin jew phenobarbital) jistgħu jnaqqsu l-effettività ta' vitamina D.
English: VANTAVO studies
Maltese: Studji dwar VANTAVO
English: SUN
Maltese: JIS
English: It is very important to follow instructions 2), 3), 4) and 5) to help the VANTAVO tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Maltese: Huwa importanti ħafna li ssegwi l-istruzzjonijiet 2), 3), 4) u 5) sabiex tgħin il-pillola ta' VANTAVO tilħaq 'l-istonku tiegħek malajr u sabiex jitnaqqas iċ-ċans li hija tirritalek il-passaġġ mill-griżmejn salistonku (esofagu - it-tubu li jgħaqqad 'il ħalqek ma l-istonku).
English: Following absorption, vitamin D3 enters the blood as part of chylomicrons.
Maltese: Wara l-assorbiment, il-vitamina D3 tidħol fid-demm bħala parti miċ-chylomicrons.
English: • your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
Maltese: • it-tabib tiegħek qallek li inti għandek esofagu ta' Barrett (kundizzjoni assoċjata ma' tibdiliet fiċ ċelluli li jinfurraw l-esofagu t'isfel),
English: Rare symptomatic hypocalcaemia, often in association with predisposing conditions.
Maltese: Dan huwa ġeneralment żgħir u mhux sintomatiku.
English: Each tablet contains 70 mg of alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3.
Maltese: pillola fiha 70 mg alendronic acid (bħala sodium trihydrate) u 70 mikrogramma (2800
English: It contains important information reminding you how to take VANTAVO properly.
Maltese: Din tinkludi informazzjoni importanti li tfakkrek kif għandek tieħu VANTAVO sew.
English: Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com
Maltese: +372 6144 200 msdeesti@merck.com
English: Vitamin D3 may increase the magnitude of hypercalcaemia and/or hypercalciuria when administered to patients with disease associated with unregulated overproduction of calcitriol (e.g. leukaemia, lymphoma, sarcoidosis).
Maltese: Vitamin D3 tista' tkabbar il-grad tal-iperkalċemija u/jew l-iperkalċijurja meta tingħata lil pazjenti b'mard assoċjat ma' produzzjoni żejda ta' calcitriol mhux reġolata (eż. lewkimja, limfoma, sarkojdożi).
English: Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a greater risk of fractures.
Maltese: Nuqqas serju ta' vitamina D jista' jwassal għal indeboliment muskolari li jista' jwassal għal waqgħat u għal riskju akbar ta' ksur.
English: †, peripheral oedema Uncommon transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
Maltese: Mhux komuni sintomi temporanji bħal f'rispons ta' fażi akuta (uġigħ fil-muskoli, telqa u f'każijiet rari, deni), tipikament marbuta mal-bidu tal-kura†
English: VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Maltese: VANTAVO mhux rakkomandat għal pazjenti b'indeboliment renali meta t-tneħħija tal-kreatinina hija anqas minn 35 ml/min (ara sezzjoni 4.2).
English: Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
Maltese: +32 (0) 27766211 dpoc_belux@merck.com