FrancophonIA/ELRC3.0 huggingface dataset:
English: Scientific reports do not support immunosuppressive effects of hydrocortisone in doses that have been used for replacement therapy in patients with adrenal insufficiency.
Maltese: Rapporti xjentifiċi ma jappoġġjawx l-effetti immunosuppressivi ta' hydrocortisone f'dożi li ntużaw għal terapija ta' sostituzzjoni f'pazjenti b'insuffiċjenza adrenali.
English: Plenadren 5 mg modified-release tablets Each modified-release tablet contains hydrocortisone 5 mg.
Maltese: Plenadren 5 mg: Kull pillola li terħi l-mediċina b'mod modifikat fiha 5 mg ta' hydrocortisone.
English: Plenadren 20 mg modified-release tablets The tablets are round (diameter 8 mm), convex and white.
Maltese: Il-pilloli huma tondi (dijametru ta' 8 mm), konvessi u bojod.
English: Plenadren 20 mg: Each modified-release tablet contains 20 mg of hydrocortisone.
Maltese: Plenadren 20 mg: Kull pillola li terħi l-mediċina b'mod modifikat fiha 20 mg ta' hydrocortisone.
English: • Erythromycin, telithromycin and clarithromycin - used to treat bacterial infections
Maltese: • Erythromycin, telithromycin u chlarithromycin - użati fil-kura ta' infezzjonijiet batterjali
English: Due to a lower bioavailability of the daily dose of Plenadren compared to that of conventional hydrocortisone tablets given three times daily (see section 5.2) clinical response needs to be monitored and further dose individualisation may be required.
Maltese: Minħabba bijodisponibilità aktar baxxa tad-doża ta' kuljum ta' Plenadren meta mqabbla ma' dik tal-pilloli konvenzjonali ta' hydrocortisone mogħtija tliet darbiet kuljum (ara sezzjoni 5.2), ir-rispons kliniku għandu jiġi mmonitorjat u jista' jkun hemm il-ħtieġa ta' individwalizzazzjoni ulterjuri tad-doża.
English: Symptoms may range from excitement/arousal to mania or psychosis.
Maltese: Is-sintomi jistgħu jvarjaw minn eċitament /tqanqil għal manija jew psikożi.
English: The pivotal study was a randomised, two-period 12-week crossover multi-centre trial in 64 patients with primary adrenal insufficiency, 11 of whom had concomitant diabetes mellitus and 11 had hypertension.
Maltese: L-istudju pivotali kien prova randomizzata, multi-ċentrika crossover fuq żewġ perjodi ta' 12-il ġimgħa fuq 64 pazjent bl-insuffiċjenza adrenali primarja, li 11 minnhom kellhom id-dijabete mellitus u 11
English: In addition they modify the body's immune responses to diverse stimuli.
Maltese: Barra minn hekk jimmodifikaw irrispons immuni tal-ġisem għal stimuli differenti.
English: Patients with adrenal insufficiency and concomitant retroviral infection, such as HIV, need careful dose adjustment due to potential interaction with antiretroviral medicinal products and increased hydrocortisone dose due to the infection.
Maltese: Pazjenti b'insuffiċjenza adrenali u infezzjoni retrovirali konkomitanti, bħall-HIV, jeħtieġu aġġustament bir-reqqa tad-doża minħabba l-potenzjal ta' interazzjoni ma' prodotti mediċinali antiretrovirali u żieda fid-doża ta' hydrocortisone minħabba l-infezzjoni.
English: Paediatric population No pharmacokinetic data are available in children or adolescents.
Maltese: Ma hemm l-ebda dejta farmakokinetika disponibbli fuq it-tfal u l-adolexxenti.
English: Adrenal crisis can develop in patients with acute adrenal insufficiency.
Maltese: Kriżi adrenali tista' tiżviluppa f'pazjenti b'insuffiċjenza adrenali akuta.
English: 40 mg is the highest maintenance dose studied.
Maltese: L-ogħla doża ta' manteniment li ġiet studjata hija ta' 40 mg.
English: Microcrystalline cellulose Pregelatinised starch (maize) Colloidal, anhydrous silica Magnesium stearate
Maltese: Is-sinjali jinkludu pressjoni tad-demm għolja, livelli elevati ta' glukożju fil-plażma u ipokalemija.
English: Date of latest renewal: 8
Maltese: Data tal-ewwel awtorizzazzjoni: 3 ta' Novembru, 2011
English: The terminal half-life of cortisol following administration of Plenadren was about 3 hours and formulation release controlled.
Maltese: Il-half-life terminali ta' kortisol wara l-għoti ta' Plenadren kien ta' madwar 3 sigħat u l formulazzjoni kienet terħi l-mediċina b'mod ikkontrollat.
English: In case of severe hepatic impairment, the functional liver mass decreases and thus the metabolising capacity for hydrocortisone.
Maltese: Filkaż ta' indeboliment epatiku sever, il-massa funzjonali tal-fwied tonqos u b'hekk il-kapaċità għallmetaboliżmu ta' hydrocortisone.
English: Plenadren 20 mg modified-release tablets Tablet coating
Maltese: Plenadren 20 mg pilloli li jerħu l-mediċina b'mod modifikat
English: Carton containing 2 bottles of 50 modified-release tablets (100 tablets).
Maltese: Kartuna li fiha 2 fliexken b'50 pillola li jerħu l-mediċina b'mod modifikat (100 pillola).
English: Plenadren comes in bottles with a screw cap containing 50 tablets.
Maltese: Plenadren jiġi fi fliexken b'għatu bil-kamin li fihom 50 pillola;
English: Animal studies have also shown that prenatal exposure to high doses of glucocorticoids (but lower than teratogenic doses) may be associated with increased risk of intrauterine growth retardation, cardiovascular disease in adulthood and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour.
Maltese: Studji fuq lannimali wrew ukoll li l-espożizzjoni prenatali għal dożi għolja ta' glukokortikojdi (iżda anqas middożi teratoġeniċi) tista' tkun assoċjata ma' żieda fir-riskju ta' ritardazzjoni ta' tkabbir fil-ġuf, mard kardjovaskulari fil-ħajja adulta u tibdil permanenti fid-densità tar-riċettur tal- glukokortikojdi, turnover tan-newrotrażmettituri u fl-imġieba.
English: Cortisol is the principal glucocorticoid secreted by the adrenal cortex.
Maltese: Kortisol huwa l-glukokortikojdi ewlieni mnixxi mill-kortiċi adrenali.
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets
Maltese: Plenadren 5 mg pilloli li jerħu l-mediċina b'mod modifikat Plenadren 20 mg pilloli li jerħu l-mediċina b'mod modifikat
English: On the other hand, the extent of absorption and bioavailability was approximately 30% higher for the 20 mg tablet after food intake compared to fasting and there was no absorption failure or dose dumping.
Maltese: Min-naħa l-oħra, l-ammont ta' assorbiment u l-bijodisponibilità kienu ta' madwar 30% ogħla għall-pillola ta' 20 mg wara t-teħid mal-ikel meta mqabbla ma' sawm u ma kienx hemm nuqqas ta' assorbiment jew dumping tad-doża.
English: Plenadren 5 mg modified-release tablets Tablet coating
Maltese: Plenadren 5 mg pilloli li jerħu l-mediċina b'mod modifikat
English: Plenadren 5 mg: the tablets are pink.
Maltese: Il-pilloli ta' 5 mg huma roża.
English: Talc
Maltese: FLIXKUN
English: Carton containing 1 bottle of 50 modified-release tablets.
Maltese: Kartuna li fiha 1 flixkun b'50 pillola li jerħu l-mediċina b'mod modifikat.
English: What Plenadren looks like and contents of the pack The modified-release tablets are round (diameter 8 mm) and convex.
Maltese: Kif jidher Plenadren u l-kontenut tal-pakkett Il-pilloli li jerħu l-mediċina b'mod modifikat huma tondi (dijametru ta' 8 mm) u konvessi.
English: Prolonged use of high doses of glucocorticoids may produce posterior subcapsular cataracts, and glaucoma with possible damage to the optic nerves.
Maltese: Mhuwiex probabbli li d-dożi ta' hydrocortisone użati fit-terapija ta' sostituzzjoni jkollhom xi impatt klinikament sinifikanti fuq it-tarbija.
English: • Heartburn, aggravation of any existing stomach ulcer
Maltese: • Ħruq ta' stonku, aggravament ta' ulċera eżistenti fl-istonku
English: Patients with adrenal insufficiency have been shown to have reduced parity, which is most likely due to the underlying disease, but there is no indication that hydrocortisone in doses for replacement therapy will affect fertility.
Maltese: Pazjenti bl-insuffiċjenza adrenali ntwerew li għandhom parità mnaqqsa, li x'aktarx hija minħabba lmarda prinċipali, iżda ma hemm l-ebda indikazzjoni li hydrocortisone f'dożi f'terapija ta' sostituzzjoni sejjer jaffettwa l-fertilità.
English: Animal experiments have shown that prenatal exposure to very high doses of glucocorticoids can induce malformations (cleft palate, skeletal malformations).
Maltese: Esperimenti fuq l-annimali wrew li l-espożizzjoni prenatali għal dożi għoljin ħafna ta' glukokortikojdi tista' twassal għal malformazzjonijiet (palat mixquq, malformazzjonijiet skeletali).
English: Long-term treatment with higher than physiological hydrocortisone doses can lead to clinical features resembling Cushing´s syndrome with increased adiposity, abdominal obesity, hypertension and diabetes, and thus result in an increased risk of cardiovascular morbidity and mortality.
Maltese: hydrocortisone ogħla minn dawk fiżjoloġiċi tista' twassal għal fatturi kliniċi li jixbħu lis-sindromu ta' Cushing b'żieda fl-adipożità, obeżità addominali, pressjoni għolja u dijabete, u b'hekk twassal għal żieda fir-riskju ta' morbidità kardjovaskulari u mwiet.
English: Stopping Plenadren may be life threatening.
Maltese: Jekk tieqaf tieħu Plenadren dan jista' jkun fatali.
English: • Raised pressure in the eye (glaucoma), clouding of the lens in the eye (cataract)
Maltese: • Żieda fil-pressjoni tal-għajnejn (glawkoma), tiċpir tal-lenti tal-għajn (kataretti)
English: NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets hydrocortisone
Maltese: Plenadren 5 mg pilloli li jerħu l-mediċina b'mod modifikat hydrocortisone
English: Psychiatric adverse reactions may occur with systemic glucocorticoids.
Maltese: Reazzjonijiet psikjatriċi avversi jistgħu jseħħu bil-glukokortikojdi sistemiċi.
English: Frequencies of these possible side effects are not known (frequency cannot be estimated from the available data).
Maltese: Il-frekwenza ta' dawn l-effetti sekondarji possibbli mhijiex magħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli).
English: Common vertigo
Maltese: Komuni vertigo
English: Common alopecia
Maltese: Komuni alopeċja
English: (malabsorption syndrome),
Maltese: (sindrome ta' assorbiment ħażin),
English: Frequencies are defined as: very common (≥1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥1/10,00 sa, < 1/1000), rari ħafna (< 1/10,000)
English: Date of first authorisation: 24 August 2005 Date of latest renewal: 24 April 2015
Maltese: Data tal-aħħar tiġdid: 24 ta' April 2015
English: The other ingredients are microcrystalline cellulose (E460), lactose anhydrous (see section 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E572), butylhydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose (E460), lactose anhydrous (ara sezzjoni 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (ara sezzjoni 2), colloidal silicon dioxide, magnesium stearate (E572), butylhydroxytoluene (E321), modified starch (maize), u sodium aluminium silicate (E554).
English: The frequency of rare was estimated based on relevant clinical trials.
Maltese: Ilfrekwenza ta' rari kienet stmata fuq bażi ta' provi kliniċi rilevanti.
English: Colecalciferol (vitamin D3)
Maltese: Colecalciferol (vitamina
English: †, pruritus Uncommon rash, erythema Rare rash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Maltese: †, ħakk Mhux Komuni raxx, eritema Rari raxx b'fotosensittività, reazzjonijiet severi tal-ġilda li jinkludu s-sindrome ta' Stevens-Johnson u nekrolisi epidermika tossika
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' 18il sena.
English: FOSAVANCE 70 mg/2,800 IU tablets EU/1/05/310/001 - 2 tablets
Maltese: FOSAVANCE 70 mg/2800 IU pilloli EU/1/05/310/001 - 2 pilloli
English: In this study alendronate daily reduced the incidence of  1 new vertebral fracture by 47 % (alendronate 7.9 % vs. placebo 15.0 %).
Maltese: F'dan l-istudju alendronate mogħti kuljum naqqas linċidenza ta'1 frattura vertebrali ġdida b' 47 % (alendronate 7.9 % kontra plaċebo 15.0
English: Also contains: lactose and sucrose.
Maltese: Fih ukoll: lactose u sucrose.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (tista' taffettwa sa persuna waħda minn kull 1,000 persuna):
English: An Instruction Card is included in the carton for FOSAVANCE.
Maltese: Il-Kard tal-Istruzzjonijiet hija inkluża fil-kartuna ta' FOSAVANCE.
English: EU/1/05/310/003 - 6 tablets
Maltese: EU/1/05/310/003 - 6 pilloli
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: FOSAVANCE 70 mg/5,600 IU tablets
Maltese: FOSAVANCE 70 mg/5600 IU pilloli
English: FOSAVANCE 70 mg/5,600 IU tablets EU/1/05/310/006 - 2 tablets EU/1/05/310/007 - 4 tablets EU/1/05/310/008 - 12 tablets
Maltese: FOSAVANCE 70 mg/5600 IU pilloli EU/1/05/310/006 - 2 pilloli EU/1/05/310/007 - 4 pilloli EU/1/05/310/008 - 12-il pillola
English: FOSAVANCE 70 mg/2,800 IU tablets FOSAVANCE 70 mg/5,600 IU tablets
Maltese: FOSAVANCE 70 mg/2800 IU pilloli FOSAVANCE 70 mg/5600 IU pilloli
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 fisserum għal  2.0 mg/dl (0.65 mmol/l) kienu simili fiż-żewġ gruppi ta' kura.
English: ; atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Maltese: ; ksur subtrochanteric u diaphyseal mhux tipiku tal-għadma tal-wirk (reazzjoni avversa tal-klassi tal-bisphosphonate)
English: EU/1/05/310/002 - 4 tablets
Maltese: EU/1/05/310/002 - 4 pilloli
English: Frequency in Clinical Trials was similar in the medicinal product and placebo group.
Maltese: Il-Frekwanza fil-Provi Kliniċi kienet simili fil-gruppi tal-prodott mediċinali u tal-plaċebo.
English: The alendronate component in the FOSAVANCE (70 mg/2,800 IU) combination tablet and the FOSAVANCE (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Maltese: Il-komponent alendronate fil-pillola kombinata FOSAVANCE (70 mg/2,800 IU) u fil-pillola kombinata FOSAVANCE (70 mg/5600 IU) huwa bijoekwivalenti għal pillola ta' 70 mg alendronate.
English: FOSAVANCE 70 mg/2,800 IU tablets
Maltese: FOSAVANCE 70 mg/2800 IU pilloli
English: EU/1/05/310/001 (2 tablets) EU/1/05/310/002 (4 tablets) EU/1/05/310/003 (6 tablets) EU/1/05/310/004 (12 tablets)
Maltese: EU/1/05/310/001 (2 pilloli) EU/1/05/310/002 (4 pilloli) EU/1/05/310/003 (6 pilloli) EU/1/05/310/004 (12-il pillola)
English: BLISTER FOR FOSAVANCE 70 mg/5,600 IU
Maltese: FOLJA GĦAL FOSAVANCE 70 mg/5600 IU
English: BLISTER FOR FOSAVANCE 70 mg/2,800 IU
Maltese: FOLJA GĦAL FOSAVANCE 70 mg/2800 IU
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: Patients in the Vitamin D3 2,800 group received FOSAVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received FOSAVANCE (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: Il-pazjenti fil-grupp tal-Vitamina D3 2800 irċevew FOSAVANCE (70 mg/2800 IU) (n=299) u l-pazjenti fil-grupp tal-Vitamina D3 5600 irċevew FOSAVANCE (70 mg/2800 IU) flimkien ma' 2,800 IU addizzjonali ta' Vitamina D3 (n=309) darba fil-ġimgħa; supplimenti ta' vitamina D addizzjonali kienu permessi.
English: Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose, intolleranza għal galactose, id-defiċjenza ta' Lapp lactase, jew lassorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: • Patients should only swallow FOSAVANCE whole.
Maltese: • Il-pazjenti għandhom jibilgħu biss pilloli FOSAVANCE sħaħ.
English: EU/1/05/310/004 - 12 tablets
Maltese: EU/1/05/310/004 - 12-il pillola
English: EU/1/05/310/006 (2 tablets) EU/1/05/310/007 (4 tablets) EU/1/05/310/008 (12 tablets)
Maltese: EU/1/05/310/006 (2 pilloli) EU/1/05/310/007 (4 pilloli) EU/1/05/310/008 (12-il pillola)
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: It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE 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'FOSAVANCE 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: Alendronate studies
Maltese: Alendronate Sintomi
English: The content of vitamin D in FOSAVANCE is not suitable for correction of vitamin D deficiency.
Maltese: Il-kontenut ta' vitamina D f'FOSAVANCE mhix adattata għal korrezzjoni ta' defiċjenza tal-vitamina D.
English: 200 ml), so that FOSAVANCE is adequately absorbed.
Maltese: 200 ml), biex b'hekk FOSAVANCE jiġi assorbit b'mod adegwat.
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 FOSAVANCE (70 mg/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Maltese: Ilperċentwali 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'FOSAVANCE (70 mg/2800 IU) kontra alendronate biss (12 % kontra 32 %, rispettivament), matul ġimgħa 15.
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 FOSAVANCE (70 mg/2,800 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'FOSAVANCE (70 mg/2800 IU) kontra alendronate biss (1 % kontra 13 %, rispettivament).
English: The effect of the lower dose of FOSAVANCE (alendronate 70 mg/vitamin D3 2,800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic post-menopausal 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: Patients received the lower strength (70 mg/2,800 IU) of FOSAVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited.
Maltese: Pazjenti ngħataw l-qawwa l-baxxa (70 mg/2800 IU)ta' FOSAVANCE ) (n=350) jew FOSAMAX (alendronate) 70 mg (n=332)darba fil-ġimgħa; supplimenti addizzjonali ta' vitamina D kienu projbiti.
English: The bioavailability of the 5,600 IU vitamin D3 in FOSAVANCE is similar to 5,600 IU vitamin D3 administered alone.
Maltese: Ilbijodisponibiltà tal-5600 IU vitamina D3 f'FOSAVANCE hija simili għal 5600
English: Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
Maltese: L-ipokalċemija għandha tiġi korretta qabel ma tinbeda t-terapija b'FOSAVANCE (ara sezzjoni 4.3).
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Maltese: 70 mg alendronic acid (bħala sodium trihydrate) u 70 mikrogramma (2800 IU) colecalciferol (vitamina
English: The bioavailability of the 2,800 IU vitamin D3 in FOSAVANCE is similar to 2,800 IU vitamin D3 administered alone.
Maltese: Ilbijodisponibiltà tal-2800 IU vitamina D3 f'FOSAVANCE hija simili għal 2800
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew talmediċini.
English: FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Maltese: FOSAVANCE huwa indikat għat-trattament tal-osteoporożi ta' wara l-menopawsa f'nisa li jinsabu f'riskju minn insuffiċjenza ta' vitamina D.
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 FOSAVANCE (70 mg/2,800 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: FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Maltese: FOSAVANCE m'huwiex irrakkomandat għal pazjenti b'indeboliment renali fejn it-tneħħija talkreatinina hija anqas minn 35 ml/min, minħabba nuqqas ta' esperjenza.
English: FOSAVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Maltese: FOSAVANCE 70 mg/5600 IU pilloli Folji tal-aluminju/aluminju f'kartun li fihom 2, 4 jew 12-il pillola.
English: Do not take FOSAVANCE
Maltese: Tiħux FOSAVANCE
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE.
Maltese: F'pazjenti b'dawn il-kundizzjonijiet, il-kalċju fis-serum u sintomi ta' ipokalċemija għandhom jiġu monitorjati waqt terapija b'FOSAVANCE.
English: THU
Maltese: TNE
English: Other medicines and FOSAVANCE
Maltese: Mediċini oħra u FOSAVANCE
English: Uncommon eye inflammation (uveitis, scleritis, or episcleritis)
Maltese: Mhux Komuni infjammazzjoni fl-għajn (uveite, sklerite jew episklerite)