qanastek/EMEA-V3 huggingface dataset:
- The medication is NOT clear, colourless and free of particles
Kellem lill- professjonist tal- kura tas- saħħa tiegħek jekk tinnota xi waħda minn dawn li ġejjin: - Il- pinna FORSETO tidher li fiha l- ħsara - Il- medikazzjoni MHIX ċara, bla kulur u mingħajr frak
• Use a new needle for each injection. • During injection, you may hear one or more clicks – this is a normal device operation. • Do not share your medication. • The FORSTEO is not recommended for use by the blind or visually impaired persons without the assistance of a person trained in the proper use of the device. • Keep the FORSTEO out of the reach and sight of children.
Il- pinna FORSTEO mhix irrakkomandata li tintuża minn persuni għomja jew b' vista batuta mingħajr l- assistenza ta 'persuna mħarrġa fl- użu korrett ta' dan l- apparat.
Manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company.
Żomm il- pinna FORSTEO fejn ma tintlaħaqx u ma tidhirx mit- tfal.
29
29 Immanifatturata minn Lilly France, F- 67640 Fegersheim, Franza għal Eli Lilly and Company.
What is Fosavance?
X' inhu Fosavance?
Fosavance is a medicine containing two active substances: alendronate sodium trihydrate and colecalciferol (vitamin D3).
Fosavance huwa mediċina li fiha żewġ sustanzi attivi: alendronat tas- sodju triidrat (alendronate sodium trihydrate) u colecalciferol (vitamina D3).
It is available as white tablets (capsule-shaped:
Huwa disponibbli f' pilloli bojod (f' forma ta 'kapsuli:
70 mg alendronate sodium trihydrate and 2,800 international units [IU] colecalciferol; rectangular:
70 mg alendronat tas- sodju triidrat u 2, 800 unità internazzjonali (IU) colecalciferol; rettangolari:
70 mg alendronate sodium trihydrate and 5,600 IU colecalciferol).
70 mg alendronat tas- sodju triidrat u 5, 600 IU colecalciferol).
What is Fosavance used for?
Għal xiex jintuża Fosavance?
Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in post-menopausal women at risk of low vitamin D levels.
Fosavance (li fih 2, 800 jew 5, 600 IU colecalciferol) jintuża fit- trattament ta 'l- osteoporożi (marda li tagħmel l- għadam fraġli) fin- nisa wara l- menopawża f' riskju ta' livelli baxxi ta 'vitamina D.
Fosavance 70 mg/ 5,600 IU is for use in patients who are not taking vitamin D supplements.
Fosavance 70 mg/ 5, 600 IU jintuża f' pazjenti li mhumiex qegħdin jieħdu supplementi tal- vitamina D.
Fosavance reduces the risk of vertebral (spine) and hip fractures (breaks).
Fosavance inaqqas ir- riskju ta 'ksur tal- vertebri (is- sinsla tad- dahar) u tal- ġenbejn.
How is Fosavance used?
Kif jintuża Fosavance?
The recommended dose is one tablet once a week.
Id- doża rakkomandata hija ta 'pillola waħda fil- ġimgħa.
Fosavance is intended for long-term use.
Fosavance huwa mediċina għal terapiji fit- tul.
The patient must take the tablet with a full glass of water (not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Il- pazjent għandu jibla 'l- pillolla b' tazza mimlija ilma (mhux ilma minerali), talanqas 30 minuta qabel kwalunkwe ikel, xorb, jew mediċina oħra (fosthom antiaċidi, supplimenti tal- kalċju u vitamini).
To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Biex tiġi evitata l- irritazzjoni ta 'l- esofagu (il- gerżuma ta' l- ikel) ladarba tittieħed il- mediċina, il- pazjent għandu jimtedd biss wara li jkun kiel għall- ewwel darba fil- ġurnata, li għandu jsir talanqas 30 minuta wara li l- pazjent jieħu l- pillola.
The tablet should not be chewed or allowed to dissolve in the mouth.
Il- pazjent ma għandux jomgħod jew iħalli l- pillola tinħall fil- ħalq.
Patients should also take calcium supplements if they are not getting enough calcium from their diet.
Jekk id- dieta normali tal- pazjent ma tipprovdilux biżżejjed kalċju, dan għandu jieħu supplimenti tal - kalċju.
How does Fosavance work?
Kif jaħdem Fosavance?
It happens when not enough new bone grows to replace the bone that is naturally broken down.
L- għadam huwa magħmul minn tessuti ħajjin li jiġġeddu permezz ta 'proċess ta' erożjoni ta 'l- għadam il- qadim (jittiekel l- għadam) u dan ta' l- aħħar jiġi sostitwit bl- istess rata minn għadam ġdid.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
L - osteoporożi hija marda li biha gradwalment l- għadam jinsilet u jsir aktar fraġli, u għalhekk ikun aktar faċli li jinkiser.
The active substances in Fosavance are alendronate and colecalciferol (vitamin D3).
Din hija marda kkawżata meta l- għadam ġdid ma jiġġenerax ruħu biżżejjed biex jissostitwixxi l- għadam li jitfarrak naturalment.
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
L- osteoporożi hija aktar komuni fin- nisa li għaddew mill- menopawża minħabba t- tnaqqis tal- livelli ta 'l- estroġeni billi dawn ta' l- aħħar jgħinu biex l - għadam jibqa 'b' saħħtu.
Reproduction is authorised provided the source is acknowledged. these cells, alendronate leads to less bone loss.
Is- sustanzi attivi f' Fosavance huma l- alendronat u colecalciferol (vitamina D3).
Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Billi jimblokka l- azzjoni taċ- ċelluli, l - alendronat iwassal għal anqas telf ta 'għadam.
Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Il- vitamina D3, kif ukoll il - forom l- oħra tal- vitamina D, hija neċessarja għall- assorbiment tal- kalċju u l- formazzjoni naturali ta 'l - għadam.
Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.
Billi waħda mill- kawżi ta 'l- osteoporożi hija kwantità insuffiċjenti ta' vitamina D3 li hi prodotta mill- esponiment għad- dawl tax- xemx, Fosavance fih il- vitamina D3.
How has Fosavance been studied?
Kif ġie studjat Fosavance?
Because alendronate and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature.
Billi l- alendronat u l- vitamina D3 diġà jintużaw separatament f' mediċini awtorizzati oħra fl- Unjoni Ewropea (UE), il- kumpanija ppreżentat dejta miksuba minn studji preċedenti u mil- letteratura ppubblikata.
The company also carried out a study in 35 men and 682 post-menopausal women with osteoporosis to show Fosavance’ s effectiveness in increasing vitamin D levels.
Barra minn hekk, il- kumpanija wettqet studju f' 35 raġel u 682 mara li għaddew mill - menopawża li jbatu mill- osteoporożi biex turi l- effikaċja ta 'Fosavance biex jgħolli l- livelli ta' vitamina D3.
Patients received either Fosavance 70 mg/ 2,800 IU or alendronate only once a week.
Lill- pazjenti ngħatalhom Fosavance 70 mg/ 2, 800 IU jew alendronat waħdu darba fil - ġimgħa.
The main measure of effectiveness was the percentage of patients with low vitamin D levels after 15 weeks.
Il- kejl ewlieni ta 'l- effikaċja kien il- perċentwal ta' pazjenti b' livelli baxxi ta 'vitamina D wara 15- il ġimgħa.
This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg/ 2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Fosavance 70 mg/ 5,600 IU).
Dan l- istudju ttawwal għal 24 ġimgħa oħra għal 652 pazjent biex jitqabblu l- effetti bejn it- tkomplija ta 'trattament b' Fosavance 70 mg/ 2, 800 IU waħdu jew b' żieda ta' 2, 800 IU vitamina D3 (li huwa ekwivalenti għal trattament b' Fosavance 70 mg/ 5, 600 IU).
What benefit has Fosavance shown during the studies?
X' benefiċċju wera Fosavance matul l- istudji mwettqa?
After 15 weeks of treatment, the proportion of patients with low vitamin D levels was lower among the patients treated with Fosavance 70 mg/ 2,800 IU (11%) than among those taking alendronate only (32%).
Wara 15- il ġimgħa ta 'trattament, il- perċentwal ta' pazjenti b' livelli baxxi ta 'vitamina D rriżulta anqas fost dawk il- pazjenti ttrattati b' Fosavance 70 mg/ 2, 800 IU (11%) meta mqabbla ma' dawk li ħadu alendronat biss (32%).
In the extension study, although similar numbers of patients taking Fosavance 70 mg/ 2,800 IU and Fosavance 70 mg/ 5,600 IU had low vitamin D levels, the patients taking Fosavance 70 mg/ 5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Fl- istudju mtawwal, minkejja li f' numru simili ta 'pazjenti ttrattati b' Fosavance 70 mg/ 2, 800 IU u b' Fosavance 70 g/ 5, 600 IU ġew osservati livelli baxxi ta' vitamina D, fil- pazjenti ttrattati b' Fosavance 70 mg/ 5, 600 IU ġew osservati żidiet ogħla fil- vitamina D fuq il- perjodu ta '24 ġimgħa li kopra l- istudju.
The company also presented evidence that the dose of alendronate included in Fosavance was the same as the dose needed to prevent bone loss.
Il- kumpanija ppreżentat ukoll evidenza li d- doża ta 'alendronat li fih Fosavance kienet l- istess bħad- doża meħtieġa għall- prevenzjoni tat- telf ta' għadam.
What is the risk associated with Fosavance?
X’ inhu r- riskju assoċjat ma 'Fosavance?
The most common side effects with Fosavance (seen in between 1 and 10 patients in 100) are headache, musculoskeletal (bone, muscle or joint) pain and gastro-intestinal symptoms such as abdominal (tummy) pain, dyspepsia (indigestion), constipation, diarrhoea, flatulence (wind), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
L- effetti sekondarji l- aktar komuni b' Fosavance (li dehru f' bejn pazjent 1 u 10 minn 100) kienu wġigħ ta 'ras, uġigħ muskoloskeletriku (għadam, muskoli, ġogi) u sintomi gastrointestinali bħal uġigħ addominali (ta' żaqq), dispepsija (indiġestjoni) stitikezza, dijarrea, flatulenza (gass), ulċeri fl- esofagu, disfaġija (diffikultà biex tibla '), distensjoni addominali (żaqq minfuħa) u tlugħ ta' aċidu mill- istonku.
For the full list of all side effects reported with Fosavance, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji kollha rrapportati b' Fosavance, ara l- Fuljett ta' Tagħrif.
Fosavance should not be used in people who may be hypersensitive (allergic) to alendronate, vitamin D3 or any of the other ingredients.
Fosavance ma għandux jintuża f' persuni li aktarx ikunu ipersensittivi (allerġiċi) għall- alendronat, għall- vitamina D3 jew għal kwalunkwe ingredjent ieħor.
It should not be used where there are abnormalities of the oesophagus (gullet), in patients who have hypocalcaemia (low calcium levels), or in patients who cannot stand or sit upright for at least 30 minutes.
Fosavance ma għandux jintuża wkoll meta jkun hemm anomaliji ta 'l- esofagu, f' pazjenti b' ipokalċemija (livelli baxxi ta' kalċju), jew f' pazjenti li ma jkunux jistgħu joqogħdu bil- wieqfa jew bil- qiegħda f' qagħda wieqfa għal talanqas 30 minuta.
Why has Fosavance been approved?
Għaliex ġie approvat Fosavance?
The Committee for Medicinal Products for Human Use (CHMP) decided that Fosavance’ s benefits are greater than its risks for the treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Fosavance huma ogħla mir- riskji tiegħu għat- trattament ta' l- osteoporożi wara l- menopawża f' pazjenti f' riskju ta 'insuffiċjenza ta' vitamina D.
The Committee recommended that Fosavance be given marketing authorisation.
Il- Kumitat irrakkomanda li Fosavance jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Fosavance:
Aktar tagħrif dwar Fosavance:
The European Commission granted a marketing authorisation valid throughout the EU for Fosavance to Merck Sharp & Dohme Ltd. on 24 August 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha, għal Fosavance lil Merck Sharp & Dohme Ltd. fl- 24 ta 'Awwissu 2005.
The full EPAR for Fosavance is available here.
L- EPAR sħiħ għal Fosavance jista 'jiġi kkonsultat hawn.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola Pillola
blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu)
folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu) folja (alu/ alu)
2 tablets 4 tablets 6 tablets 12 tablets 40 tablets 2 tablets 4 tablets 12 tablets 40 tablets
2 pilloli 4 pilloli 6 pilloli 12- il pillola 40 pillola 2 pilloli 4 pilloli 12- il pillola 40 pillola
FOSAVANCE 70 mg/ 2800 IU tablets
FOSAVANCE 70 mg/ 2800 IU pilloli
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate, and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Kull pillola fiha 70 mg alendronic acid bħala alendronate sodium trihydrate, u 70 mikrogramma (2800 IU) colecalciferol (vitamina D3).
Each tablet contains 62 mg lactose anhydrous and 8 mg sucrose.
Kull pillola fiha 62 mg lactose anhydrous u 8 mg sucrose.
Capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '710 'on the other.
Pilloli f' għamla ta 'kapsula, bojod għal bojod jagħtu fil- griż, immarkati b' kontorn ta' immaġni ta 'għadma fuq naħa, u' 710 'fuq in- naħa l- oħra.
Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
Għat- trattament ta 'l- osteoporożi ta' wara l- menopawsa f' pazjenti li jinsabu f' riskju minn insuffiċjenza ta 'vitamina D.
FOSAVANCE reduces the risk of vertebral and hip fractures.
FOSAVANCE inaqqas ir- riskju ta 'ksur vertebrali u tal- ġenbejn.
The recommended dosage is one FOSAVANCE tablet once weekly.
Id- doża rakkomandata hija pillola FOSAVANCE waħda darba fil- ġimgħa.
Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use.
Minħabba n- natura tal- proċess tal- marda fl- ostoeporożi, FOSAVANCE hu intiż biex jintuża fuq perijodu ta 'żmien twil.
To permit adequate absorption of alendronate:
Sabiex ikun hemm assorbiment adegwat ta 'alendronate:
FOSAVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
FOSAVANCE għandu jittieħed ma 'l- ilma biss (mhux ilma minerali) ta' l- anqas 30 minuta qabel l - ewwel ikel, xorb jew prodott mediċinali (li jinkludi antaċidi, supplimenti tal- kalċju u vitamini) tal- jum.
Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5).
Xorb ieħor (li jinkludi l- ilma minerali), ikel u xi prodotti mediċinali oħrajn wisq probabbli nnaqqsu l - assorbiment ta 'alendronate (ara sezzjoni 4. 5).
The following instructions should be followed exactly in order to minimize the risk of oesophageal irritation and related adverse reactions (see section 4.4):
L- istruzzjonijiet li ġejjin għandhom jiġu segwiti bl- eżatt sabiex jitnaqqas ir- riskju ta ’ irritazzjoni ta ’ l - esofagu u reazzjonijiet avversi relatati (ara sezzjoni 4. 4):
• FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200ml or 7fl. oz.).
• FOSAVANCE għandu jinbela ’ biss ma ’ tazza mimlija bl- ilma (mhux anqas minn 200 ml jew 7uq. fl.) filgħodu wara li l- pazjent iqum.
• Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
• Il- pazjenti m’ għandhomx jomogħdu l- pillola jew iħallu l- pillola tinħall f’ ħalqhom minħabba l - potenzjal ta ’ ulċerazzjoni orofarinġjali.
• Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
• Il- pazjenti m’ għandhomx jimteddu sakemm jieħdu l- ewwel ikel tal- jum li għandu jkun ta ’ l - anqas 30 minuta wara t- teħid tal- pillola.
• Patients should not lie down for at least 30 minutes after taking FOSAVANCE.
2 • Il- pazjenti m' għandhomx jimteddu għal talanqas 30 minuta wara li jieħdu FOSAVANCE.
2 • FOSAVANCE should not be taken at bedtime or before arising for the day.
• FOSAVANCE m' għandux jittieħed fil- ħin ta 'qabel l- irqad jew qabel il- ħin tal- qawmien għall - jum.
Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4).
Il- pazjenti għandhom jingħataw kalċju supplimentali jekk it- teħid tiegħu mad- dieta ma jkunx adegwat (ara sezzjoni 4. 4).
Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.
Supplimentazzjoni addizzjonali bil- vitamina D għandha tiġi kunsidrata fuq bażi individwali billi jittieħed kont ta ’ kwalunkwe teħid ta ’ vitamina D minn vitamini u supplimenti tad - dieta.
The equivalence of intake of 2800 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 400 IU has not been studied.
L- ekwivalenza ta ’ teħid ta ’ 2800 IU ta ’ vitamina D3 kull ġimgħa f’ FOSAVANCE mad- doża ta ’ kuljum ta ’ 400 IU ta ’ vitamina D ma ġietx mistħarrġa.
In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate.
Użu f' pazjenti anzjani Fi studji kliniċi ma kienx hemm differenza fil- profili tal- effikaċja jew tas- sigurtà ta 'alendronate nkoness mal- età.
Therefore no dosage adjustment is necessary for the elderly.
Għalhekk l- ebda aġġustament fid- doża m' huwa meħtieġ għall- anzjani.
No dosage adjustment is necessary for patients with a glomerular filtration rate (GFR) greater than 35ml/ min.
Użu f’ indeboliment renali L- ebda aġġustament fid- doża ma hija meħtieġa għal pazjenti b’ rata ta ’ filtrazzjoni glomerulari (GFR) ta ’ aktar minn 35ml/ min.
FOSAVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min, due to lack of experience.
FOSAVANCE mhux rakkomandat għal pazjenti b’ indeboliment renali meta l- GFR hija anqas minn 35ml/ min, minħabba nuqqas ta ’ esperjenza.
FOSAVANCE has not been studied in children and adolescents and therefore should not be given to them.
Użu fi tfal u adoloxxenti FOSAVANCE ma ġiex studjat fi tfal u adoloxxenti u għalhekk m' għandux jingħatalhom.
• Hypersensitivity to the active substances or to any of the excipients.
• Sensittività eċċessiva għas- sustanza attiva jew għal sustanzi mhux attivi.
• Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
• Anormalitajiet ta ’ l- esofagu u fatturi oħra li jdewmu t- tbattil ta ’ l- esofagu bħal tidjiq jew twessigħ.
• Inability to stand or sit upright for at least 30 minutes.
• Nuqqas ta ’ kapacità li toqgħod bilwieqfa jew bilqieghda dritt għal ta ’ l- anqas 30 minuta.
• Hypocalcaemia.
• Ipokalċemija
Alendronate Alendronate can cause local irritation of the upper gastrointestinal mucosa.
Alendronate Alendronate jista ’ jikkaġuna irritazzjoni lokali tal- mukoża gastrointestinali tan- naħa ta ’ fuq.
Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Minħabba li hemm il- potenzjal għal deterjorament tal- marda prinċipali, għandha tintuża l- kawtela meta alendronate jingħata 'l pazjenti bi problemi gastrointestinali attivi tan- naħa ta ’ fuq, bħal disfaġja, mard ta' l- esofaġu, gastrite, duwodenite, ulċeri, jew bi storja riċenti (fi żmien l- aħħar sena) ta ’ mard gastrointestinali maġġur bħal ulċeri peptiċi, jew emorraġiji gastrointestinali attivi, jew kirurġija fuq il - passaġġ gastrointestinali tan- naħa ta ’ fuq ħlief għal piloroplasti (ara sezzjoni 4. 3).
Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate.
Reazzjonijiet esofaġiċi (xi kultant serji u li jeħtieġu d- dħul fl- isptar), bħal esofaġite, ulċeri esofaġiċi u erożjonijiet esofaġiċi, rarament segwiti b' tidjiq esofaġiku, ġew irrapportati f’ pazjenti li qed jieħdu alendronate.
Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn (see section 4.8).
It- tobba għandhom għalhekk ikunu żvelti għal kwalunkwe sinjali jew sintomi li possibbilment jindikaw reazzjoni esofiġika u l- pazjenti għandhom jiġu informati biex iwaqqfu alendronate u jfittxu l- attenzjoni medika jekk jiżviluppaw sintomi ta ’ irritazzjoni esofaġika bħal disfaġja, uġigħ waqt li jkunu qed jibilgħu jew uġigħ wara l- isternu jew qrusa fl- istonku ġdida jew li taggrava (ara sezzjoni 4. 8).
The risk of severe oesophageal adverse reactions appears to be greater in patients who fail to take alendronate properly and/ or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation.
Ir- riskju ta ’ reazzjonijiet avversi esofaġiċi serji jidher li huwa akbar f’ pazjenti li ma jieħdux alendronate kif suppost u/ jew ikomplu jiehdu alendronate wara li jiżviluppaw sintomi suġġestivi ta ’ irritazzjoni esofaġika.
It is very important that the full dosing instructions are provided to, and are understood by the patient (see section 4.2).
Huwa importanti ħafna li l- istruzzjonijet kompluti fuq l- iddożar huma mogħtija,
Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.
Il- pazjenti għandhom jiġu infurmati li fin- nuqqas li jsegwu dawn l- istruzzjonijiet jista ’ jiżdidilhom ir- riskju ta ’ problemi esofaġiċi.
3 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).
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).
Osteonecrosis of the jaw, generally associated with tooth extraction and/ or local infection (including osteomyelitis), has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates.
Osteonekrożi tax- xedaq, ġeneralment assoċjata ma ’ qlugħ tas- snien u/ jew infezzjonijiet lokali (inklużi osteomajlite) ġiet irrapportata f’ pazjenti bil- kanċer li qed jieħdu reġimen ta ’ trattamenti li jinkludu bisphosphonates mogħtija prinċipalment minn ġol- vina.
Many of these patients were also receiving chemotherapy and corticosteroids.
Hafna minn dawn il- pazjenti kienu qed jieħdu wkoll kemoterapija u kortikosterojdi.
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
Osteonekrożi tax- xedaq ġiet ukoll irrapportata f’ pazjenti b’ osteoporożi li jkunu qed jingħataw bisphosphonates orali.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, periodontal disease).
Eżami dentali b’ dentistrija preventiva adattata għandha tiġi kkunsidrata qabel trattament bil - bisphosphonates f’ pazjenti b’ fatturi ta ’ riskju konkomitanti (ez. kanċer, kemoterapija, radjuterapija, kortikosterojdi, iġene orali mhux adegwata, mard perjodontali).
While on treatment, these patients should avoid invasive dental procedures if possible.
Waqt it- trattament, dawn il- pazjenti għandhom jevitaw proċeduri dentali invażivi jekk huwa possibbli.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Għal pazjenti li jiżviluppaw osteonekrożi tax- xedaq waqt li jkunu fuq terapija b' bisphosphonates, kirurġija dentali tista ’ tħarrax il- kundizzjoni.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Għal pazjenti li jeħtieġu proċeduri dentali, m’ hemm l - ebda dejta li tisuġġerixxi li l- waqfien tat- trattament b' bisphosphonates inaqqas ir- riskju ta ’ osteonekrożi tax- xedaq.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Il- ġudizzju kliniku tat- tabib kuranti għandu jigwida l- pjan ta ’ tmexxija ta ’ kull pazjent msejjes fuq stima ta ’ siwi/ riskju individwali.
Bone, joint, and/ or muscle pain has been reported in patients taking bisphosphonates.
Uġigħ fl- għadam, fil- ġogi u/ jew fil- muskoli ġie rapportat f’ pazjenti li qed jieħdu l- bisphosphonates.
In post-marketing experience, these symptoms have rarely been severe and/ or incapacitating (see section 4.8).
F’ esperjenzi ta ’ wara t- tqegħid fis- suq, dawn is- sintomi rarament kienu serji u/ jew inkapaċitanti (ara sezzjoni 4. 8).
The time to onset of symptoms varied from one day to several months after starting treatment.
Il- bidu tad- dehra tas- sintomi varjat minn jum għal diversi xhur wara l- bidu tat - trattament.
Most patients had relief of symptoms after stopping treatment.
Il- parti l- kbira tal- pazjenti kellhom serħan mis- sintomi wara li waqqfu t- trattament.
A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.
Subset minnhom kellhom rikorenza tas- sintomi meta ġew sfidati mill- ġdid bl- istess prodott mediċinali jew bisphosphonate ieħor.
Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember.
Il- pazjenti għandhom jiġu mgħarrfa li jekk jaqbzu doża ta ’ FOSAVANCE għandhom jieħdu pillola fl - għodwa ta ’ wara li jiftakru.
They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
M’ għandhomx jieħdu żewġ pilloli fl- istess jum imma għandhom imorru lura għal li jieħdu pillola darba fil- ġimgħa, kif kien oriġinalment skedat fil- ġurnata magħzula minnhom.
FOSAVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min (see section 4.2).
FOSAVANCE mhux rakkomandat għal pazjenti b’ indeboliment renali meta l- GFR hija anqas minn 35ml/ min (ara sezzjoni 4. 2).
Causes of osteoporosis other than oestrogen deficiency and ageing should be considered.
Kawżi għall- osteoporożi minħabba nuqqas ta 'estroġen u x- xjuħija għandhom jiġu konsidrati.
Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
L- ipokalċemija għandha tiġi korretta qabel ma tinbeda t- terapija b’ FOSAVANCE (ara sezzjoni 4. 3).
Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting FOSAVANCE.
Mard ieħor li jaffetwa l- metaboliżmu minerali (bħal defiċjenza fil- vitamina D u ipoparatirojdiżmu) għandhom jiġu wkoll ittrattati effettivament qabel ma jinbeda FOSAVANCE.
The content of vitamin D in FOSAVANCE is not suitable for correction of vitamin D deficiency.
Il- kontenut ta ’ vitamina D f’ FOSAVANCE mhix adattata għal korrezzjoni ta ’ defiċjenza tal- vitamina D.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE.
F’ pazjenti b’ dawn il - kundizzjonijiet, il- kalċju fis- serum u sintomi ta ’ ipokalċemija għandhom jiġu monitorjati waqt terapija b’ FOSAVANCE.
Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur.
Minħabba l- effetti pożittivi ta ’ alendronate fiż- żjieda tal- minerali fl- għadam, tnaqqis fil- livelli tal - kalċju fis- serum u fil- fosfat jista ’ jseħħ.
These are usually small and asymptomatic.
Dan huwa ġeneralment żgħir u mhux sintomatiku.
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).
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).
Colecalciferol 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).
4 Colecalciferol Vitamin D3 tista ’ tkabbar il- grad ta 'l- iperkalċemija u/ jew l- iperkalċijurja meta tingħata lil pazjenti b’ mard assoċjat ma ’ produzzjoni żejda ta ’ calcitriol mhux reġolata (eż. lewkimja, limfoma, sarkojdożi).
Urine and serum calcium should be monitored in these patients.
Il- kalċju fis- serum u fl- awrina għandu jiġi monitorjat f’ dawn il- pazjenti.
Patients with malabsorption may not adequately absorb vitamin D3.
Pazjenti b’ malassorbiment jistgħu ma jassorbux il- vitamina D3 adegwatament.
4 Excipients This medicinal product contains lactose and sucrose.
Dan il- prodott mediċinali fih il- lactose u s- sucrose.
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.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal fructose, intolleranza għal galactose, id- defiċjenza ta 'Lapp lactase, jew l- assorbiment ħażin ta' glucose- galactose jew insuffiċjenza ta ’ sucrase- isomaltase m’ għandhomx jieħdu din il- mediċina.
Alendronate If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate.
Alendronate Huwa probabbli li ikel u xorb (li jinkludi l- ilma minerali), supplimenti tal- kalċju, antaċidi, u xi prodotti mediċinali orali ser itellfu l- assorbiment ta ’ alendronate, jekk jittieħdu fl- istess ħin.
Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
Għalhekk, il- pazjenti għandhom jistennew ta ’ l- anqas 30 minuta wara li jieħdu alendronate qabel ma jieħdu xi prodott medicinali orali ieħor (ara sezzjoni 4. 2 u 5. 2).
No other clinically significant interactions with medicinal products are anticipated.
L- ebda interazzjoni klinikament sinjifikanti ma ’ prodotti mediċinali ta ’ sinifikat kliniku ma hija mistennija.
A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate.
Għadd ta 'pazjenti fi provi kliniċi ngħataw estroġenu (intravaġinali, transdermali, jew orali) waqt it- teħid ta ’ alendronate.
No adverse reactions attributable to their concomitant use were identified.
L- ebda reazzjonijiet avversi minħabba l- użu konkomitanti tagħhom ma ġew identifikati.
Although specific interaction studies were not performed, in clinical studies alendronate was used concomitantly with a wide range of commonly prescribed medicinal products without evidence of interactions of clinical relevance.
Għalkemm studji dwar interazzjonijiet speċifiċi ma sarux, fi studji kliniċi alendronate kien użat flimkien ma ’ firxa kbira ta ’ prodotti mediċinali komuni mogħtija b’ riċetta ta ’ tabib mingħajr evidenza ta ’ interazzjonijiet ta ’ relevanza klinika.
Colecalciferol Olestra, mineral oils, orlistat, and bile acid sequestrants (e. g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Colecalciferol Olestra, żjut minerali, orlistat, u sekwestranti tal- aċidi biljari (eż. cholestyramine, colestipol) jistgħu jimpedixxu l- assorbiment ta ’ vitamina D.
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Antikonvulsanti, cimetidine u thiazides jistgħu jżiedu l - kataboliżmu ta ’ vitamina D.
Additional vitamin D supplements may be considered on an individual basis.
Supplimenti addizjonali tal- vitamina D jistgħu jiġu kunsidrati fuq bażi individwali.
FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
FOSAVANCE jintuża biss għal użu f’ nisa wara l- menopawża u għalhekk m’ għandux jiġi użat waqt it - tqala jew f’ nisa li jreddgħu.
There are no adequate data from the use of FOSAVANCE in pregnant women.
Ma hemm l- ebda dejta adekwata dwar l- użu ta ’ FOSAVANCE f’ nisa tqal.
Animal studies with alendronate do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, or postnatal development.
Studji bl- alendronate fl - annimali ma indikawx effetti ta ’ ħsara diretti b’ rispett għat- tqala, żvilupp embrijonali/ fetali, jew żvilupp ta ’ wara t- twelid.
Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3).
Alendronate mogħti waqt it- tqala fil- firien ikawża distoċja relatata ma 'l - ipokalċemija (ara sezzjoni 5. 3) Studji fl- annimali wrew iperkalċemija u tossiċità riproduttiva b’ dożi għoljin ta ’ vitamina D (ara sezzjoni 5. 3).
It is not known whether alendronate is excreted into human breast milk.
Mhux magħruf jekk alendronate jiġix eliminat fil- ħalib tal- bniedem.
Colecalciferol and some of its active metabolites pass into breast milk.
Colecalciferol u xi ftit mill - metaboliti attivi tiegħu jgħaddu fil- ħalib tal- omm.
However, there is no information to indicate that FOSAVANCE affects a patient’ s ability to drive or operate machines.
Madankollu, m’ hemmx informazzjoni li tindika li FOSAVANCE jaffettwa l- ħila ta 'pazjent biex issuq jew iħaddem magni.
The following adverse reactions have been reported during clinical studies and/ or post-marketing use with alendronate.
Ir- reazzjonijiet avversi li ġejjin ġew irraportati waqt l- istudji kliniċi u/ jew l- użu wara t- tqegħid fis- suq b' alendronate.
No additional adverse reactions have been identified for FOSAVANCE.
L- ebda reazzjoni avversa addizzjonali ma ġiet identifikata għal FOSAVANCE.
[Common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1000), very rare (< 1/ 10,000)]
[Komuni (≥1/ 100, < 1/ 10), mhux komuni (≥1/ 1000, < 1/ 100), rari (≥1/ 10, 000, < 1/ 1000), rari ħafna (< 1/ 10, 000)]
5 Nervous system disorders:
Komuni: uġigħ ta ’ ras Disturbi fis- sistema nervuża:
Gastrointestinal disorders:
Rari: uveite, sklerite, episklerite Disturbi fl- għajnejn:
Rare: uveitis, scleritis, episcleritis Common: abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation Uncommon: nausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melena Rare: oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding)(see section 4.4). *See sections 4.2 and 4.4
Komuni: uġigħ addominali, dispepsja, stitikezza, dijarea, gass, ulċera Disturbi gastro - esofagali *, disfaġja *, distensjoni addominali, regurġitazzjoni ta ’ l - intestinali: aċidu Mhux komuni: dardir, rimettar, gastrite, esofaġite *, taħfir esofagali *, melena Rari: tidjiq esofagali *, ulċerazzjoni orofarinġali *, upper gastrointestinal PUBs (perforazzjonijiet, ulċeri, fsada) (ara sezzjoni 4. 4). * Ara sezzjoni 4. 2 u 4. 4 Mhux komuni: raxx, ħakk, eritema Disturbi fil- ġilda u fit - Rari: raxx b’ fotosensittività tessuti ta ’ taħt il- ġilda:
Uncommon: rash, pruritus, erythema Rare: rash with photosensitivity Very rare: severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Rari ħafna: reazzjonijiet severi tal- ġilda li jinkludu s- sindrome ta ’ Stevens- Johnson u nekrolisi epidermika tossika Komuni: uġigħ muskoluskeltrali (għadam, muskoli jew ġogi) Disturbi muskolu - Rari: uġigħ muskoluskeltrali serju (għadam, muskoli jew ġogi) (ara skeltrali u tal- connective sezzjoni 4. 4) tissue:
Musculoskeletal and connective tissue disorders:
Rari: ipokalċemija sintomatika, sikwit marbuta ma ’ kondizzjonijiet li Disturbi fil- metaboliżmu għalihom hemm predisposizzjoni.
Metabolism and nutrition disorders:
(ara sezzjoni 4. 4) u n- nutrizzjoni:
General disorders and administration site conditions:
Rari: sintomi għaddiena bħal f’ rispons ta ’ fażi akuta (uġigħ fil - Disturbi ġenerali u muskoli, telqa u f’ każijiet rari, deni), tipikament marbuta mal- bidu tal - kundizzjonijiet ta ’ mnejn kura. jingħata:
Immune system disorders:
Rari: reazzjonijiet ta ’ sensittività eċċessiva fosthom urtikarja u Disturbi fis- sistema anġjoedema immuni:
Rare: hypersensitivity reactions including urticaria and angioedema
Matul l- esperjenza ta ’ wara t- tqegħid fis- suq ġew irrapportati r- reazzjonijiet li ġejjin (frekwenza mhux magħrufa):
Nervous system disorders:
sturdament Disturbi fis- sistema nervuża: vertiġini Disturbi fil- widnejn u fis- sistema labirintika:
Skin and subcutaneous tissue disorders:
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda Disturbi muskolu - skeltrali u tal- connective tissue:
Musculoskeletal, connective tissue and bone disorders:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
alopesja Osteonekrosi tax- xedaq ġiet irrapportata f’ pazjenti ttrattati b’ bisphosphonates.
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Il- maġġoranza tar- rapporti jirreferu għal pazjenti morda bil- kanċer, iżda każijiet bħal dawn ġew irrapportati wkoll f’ pazjenti kkurati għal osteoporożi.
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
L- osteonekrosi tax- xedaq ġeneralment hija assoċjata mal- qlugħ tas- snien u/ jew infezzjoni lokali (fosthom osteomjelite).
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4); joint swelling.
Id- dijanjosi ta ’ kanċer, il- kimoterapija, ir - radjuterapija, il- kortikosterojdi u iġjene orali mhux adegwata huma wkoll meqjusa bħala fatturi ta ’ riskju (ara sezzjoni 4. 4); nefħa fill - ġogi. astenja, edema periferali
Alendronate Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Alendronate Ipokalċemija, ipofosfatemija u reazzjonijiet avversi gastrointestinali tan- naħa ta ’ fuq, bħall- istonku mħawwad, qrusa fl- istonku, esofaġite, gastrite, jew ulċeri, jistgħu jirriżultaw minn doża orali eċċessiva.
No specific information is available on the treatment of overdose with alendronate.
Ma hemm l- ebda tagħrif speċifiku fuq it- trattament ta 'doża eċċessiva b' alendronade.
In case of overdose with FOSAVANCE, milk or antacids should be given to bind alendronate.
F’ kaz ta ’ doża eċċessiva b’ FOSAVANCE, ħalib jew antaċidi għandhom jingħataw biex jintrabtu ma 'alendronate.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Minħabba r- riskju ta ’ irritazzjoni esofaġeali, ir- remettar m’ għandux jiġi mqanqal u l- pazjent għandu jibqa 'bilwieqfa.
Colecalciferol Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/ day.
Colecalciferol Ma ġietx dokumentata waqt terapija kronika f’ adulti li huma ġeneralment b’ saħħithom tossiċità bil - vitamina D f’ doża ta ’ anqas minn 10, 000 IU/ kuljum.
In a clinical study of healthy adults a 4000 IU daily dose of vitamin D3 for up to five months was not associated with hypercalciuria or hypercalcaemia.
Fi studju kliniku fuq adulti b’ saħħithom doża ta ’ 4000 IU kuljum ta 'vitamina D3 sa żmien ħames xhur ma kinetx assoċjata ma ’ iperkalċijurja jew iperkalċemija.
Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku
Bisphosphonates, combinations, ATC code:
Kombinazzjonijiet ta ’ bisphosphonates, Kodiċi ATC:
FOSAVANCE is a combination tablet containing the two active substances alendronate sodium trihydrate and colecalciferol (vitamin D3).
FOSAVANCE hija pillola kombinata li fiha ż- żewġ sustanzi attivi alendronate sodium trihydrate u colecalciferol (vitamina D3).
Alendronate Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation.
Alendronate Alendronate sodium huwa bisphosphonate li jimpedixxi l- assorbiment osteoklastiku mill- ġdid ta ’ l - għadam mingħajr effett dirett fuq il- formazzjoni ta ’ l- għadam.
Preclinical studies have shown preferential localisation of alendronate to sites of active resorption.
Studji ta 'qabel l- użu kliniku wrew lokalizzazzjoni preferenzjali ta ’ alendronate għas- siti attivi ta ’ assorbiment mill- ġdid.
Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected.
Attività osteoklastika hija impeduta, imma r- rekrutaġġ jew twaħħil ta ’ osteoklasti mhux effettwat.
The bone formed during treatment with alendronate is of normal quality.
L- għadam iffurmat waqt trattament b’ alendronate huwa ta ’ kwalità normali.
Colecalciferol (vitamin D3) Vitamin D3 is produced in the skin by conversion of 7-dehydrocholesterol to vitamin D3 by ultraviolet light.
Colecalciferol (vitamina D3) Il- vitamina D3 hija magħmula fil- ġilda permezz tal- bidla ta ’ 7- dehydrocholesterol għal vitamina D3 bid- dawl ultravjola.
In the absence of adequate sunlight exposure, vitamin D3 is an essential dietary nutrient.
Fin- nuqqas ta ’ esponiment adekwat għad- dawl tax- xemx, il- vitamina D3 hija nutrijent essenzjali tad- dieta.
Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Il- vitamin D3 hija mibdula f’ 25- hydroxyvitamin D3 fil- fwied, u maħżuna sakemm tkun meħtieġa.
Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Il- bidla għal ormon mobilizzanti tal- kalċju attiv 1, 25- dihydroxyvitamin D3 (calcitriol) fil- kilwa hija strettament irregolata.
The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
L- azzjoni prinċipali ta '1, 25- dihydroxyvitamin D3 hija li żżid l- assorbiment intestinali kemm tal- kalċju u l- fosfat kif ukoll li tirregola l- kalċju fis- serum, il - kalċju renali u l- eliminazzjoni tal- fosfat, il- formazzjoni ta ’ l- għadam u l- assorbiment mill- ġdid ta ’ l - għadam.
Vitamin D3 is required for normal bone formation.
Vitamin D3 hi meħtieġa għal formazzjoni normali ta ’ l- għadam.
Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate.
Insuffiċjenza ta ’ vitamina D tiżviluppa meta kemm l- esponiment għad- dawl tax- xemx u kemm it- teħid fid- dieta huma inadekwati.
Insufficiency is associated with negative calcium balance, bone loss, and increased risk of skeletal fracture.
L- insuffiċjenza hija assoċjata ma ’ bilanċ tal- kalċju negattiv, telf ta ’ l- għadma, u riskju aktar ta ’ fratturi skeletriċi.
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.
7 dgħjufija tal- muskoli prossimali u osteomalaċja, li tkompli żżid ir- riskju ta ’ waqgħat u fratturi f’ individwi osteoporotiċi.
Supplemental vitamin D reduces these risks and their consequences.
Vitamina D supplimentari tnaqqas dawn ir- riskji u l- konsegwenzi tagħhom.
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.
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.
FOSAVANCE studies The effect of FOSAVANCE (alendronate 70 mg/ vitamin D3 2800 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]).
Studji dwar FOSAVANCE L- effett ta ’ FOSAVANCE (alendronate 70 mg/ vitamin D3 2800 IU) fuq l- istat tal- vitamina D kien muri fi studju multinazzjonali ta ’ 15- il ġimgħa li rreġistra 682 nisa ta ’ wara l- menopawża 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]).
Patients received the lower strength (70 mg/ 2800 IU) of FOSAVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements
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.
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26%) in the FOSAVANCE (70 mg/ 2800 IU) group (56 nmol/ l [23 ng/ ml]) than in the alendronate-only group (46 nmol/ l [18.2 ng/ ml]).
Wara 15- il ġimgħa ta ’ trattament, il- livelli medji ta ’ 25- hydroxyvitamin D fis- serum kienu sinifikattivament ogħla (26%) fil- grupp FOSAVANCE (70 mg/ 2800 IU) (56 nmol/ l [23 ng/ ml]) milli fil- grupp ta ’ alendronate biss (46 nmol/ l [18. 2 ng/ ml]).
32%, respectively), through week 15.
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’ FOSAVANCE (70 mg/ 2800 IU) kontra alendronate biss (12% kontra 32%, rispettivament), matul ġimgħa 15.
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/ 2800 IU) vs. alendronate-only (1% vs 13%, respectively).
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).
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/ 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).
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. 9 ng/ ml) f’ ġimgħa 15 fil- grupp FOSAVANCE (70 mg/ 2800 IU) (n=75) u naqsu minn 30 nmol/ l (12. 0 ng/ ml) fil- linja bażi għal 26 nmol/ l (10. 4 ng/ ml) f’ ġimgħa 15 fil- grupp alendronate- biss (n=70).