qanastek/EMEA-V3 huggingface dataset:
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Ma kien hemm l- ebda differenzi bejn il- gruppi tat- trattament fil - medji tal- kalċju u tal- fosfat fis- serum, jew fil- kalċju fl- awrina ta ’ 24 siegħa.
Alendronate studies 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.
Studji fuq alendronate 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 bl - osteoporożi.
The mean increases from baseline in lumbar spine BMD at one year were 5.1% (95% CI:
Iż- żjidiet medji mill- linja bażi ta 'riferiment fis- sinsla lumbari fi żmien sena kienu 5. 1% (95% CI:
4.8, 5.4%) in the 70 mg once-weekly group and 5.4% (95% CI:
4. 8, 5. 4%) fil- grupp ta ’ 70 mg darba fil- ġimgħa u 5. 4% (95% CI:
5.0, 5.8%) in the 10 mg daily group.
5. 0, 5. 8%) fil- grupp ta ’ 10 mg kuljum.
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.
Iż- żjidiet medja fil- BMD kienu 2. 3% u 2. 9% fl- għonq tal- femora u 2. 9% u 3. 1% fl - għadam tal- ġenbejn totali fil- gruppi ta ’ 70 mg darba fil- ġimgħa u 10 mg kuljum, rispettivament.
The two treatment groups were also similar with regard to BMD increases at other skeletal sites.
Iż - żewġ ġruppi tat- trattament kienu ukoll simili fir- rigward ta ’ żjidiet fil- BMD f’ siti skeletriċi oħrajn.
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).
L- effetti ta ’ alendronate fuq il- massa ta ’ l- għadma u l- inċidenza ta ’ fratturi f’ nisa wara l- menopawża kienu eżaminati f’ żewġ studji ta ’ l- effikaċja fil- bidu ta ’ disinn identiku (n=994) kif ukoll fil- Fracture Intervention Trial (FIT: n=6, 459).
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.
Fl- istudji ta ’ l- effikaċja fil- bidu, żjidiet fil- BMD medja b ’ alendronate 10 mg/ kuljum relattivament ma ’ plaċebo fi żmien tliet snin kienu 8. 8%, 5. 9% u 7. 8% fis- sinsla, fl- għonq femurali u fit - trochanter, rispettivament.
Total body BMD also increased significantly.
Il- BMD totali tal- ġisem ukoll żdiedet sinifikattivament.
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.
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.
In the two-year extension of these studies BMD at the spine and trochanter continued to increase and BMD at the femoral neck and total body were maintained.
Fl - estensjoni ta ’ sentejn ta ’ dawn l- istudji l- BMD fis- sinsla u fit- trochanter kompliet tiżdied u l- BMD fl - għonq femurali u fil- ġisem totali kienet miżmuma.
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):
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):
A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture.
Studju ta ’ tliet snin fuq 2, 027 pazjenti li kellhom ta ’ l- anqas frattura (ta ’ kompressjoni) vertebrali waħda fil- linja bażi ta 'riferiment.
In this study alendronate daily reduced the incidence of ≥ 1 new vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
F’ dan l- istudju alendronate mogħti kuljum naqqas l - inċidenza ta’ ≥1 frattura vertebrali ġdida b ’ 47% (alendronate 7. 9% kontra plaċebo 15. 0%).
2.2%, a reduction of 51%).
Barra minn hekk, tnaqqis statistikament sinifikattiv instab fl- inċidenzi ta ’ fratturi tal- għadam tal - ġenbejn (1. 1% kontra 2. 2%, tnaqqis ta ’ 51%).
A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture.
Studju ta ’ erba ’ snin fuq 4, 432 pazjenti b’ massa ta ’ l- għadam baxx imma mingħajr fratturi vertebrali fil- linja bażi ta 'riferiment.
5.8%, a reduction of 50%).
F’ dan l- istudju, differenza sinifikattiva kienet osservata fl- analiżi ta ’ sottogrupp ta ’ nisa osteoporotiċi (37% tal- popolazzjoni globali li jikkorispondu mad- definizzjoni 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%).
Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Absorption Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast.
Assorbiment B' mod relattiv ma 'doża ta ’ referenza mogħtija ġol- vina, il- bijodisponibiltà orali medja ta ’ alendronate fin- nisa kienet 0. 64% għal dożi li jvarjaw minn 5 sa 70 mg meta mogħtija wara sawma ta' matul il- lejl u sagħtejn qabel kolazzjon standardizzat.
Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast.
Il- bijodisponibiltà kienet l- istess imnaqqsa għal stima ta ’ 0. 46% u 0. 39% meta alendronate kien mogħti siegħa jew nofs siegħa qabel kolazzjon standardizzat.
In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
Fi studji fuq l- osteoporożi, alendronate kien effettiv meta ngħata ta ’ l- anqas 30 minuta qabel l- ewwel ikel jew xorb tal- jum.
The alendronate component in the FOSAVANCE (70 mg/ 2800 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Il- komponent alendronate fil- pillola kombinata FOSAVANCE (70 mg/ 2800 IU) huwa bijoekwivalenti għal pillola ta ’ 70 mg alendronate.
Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast.
Il- bijodisponibiltà kienet negliġibbli kemm jekk alendronate kien mogħti ma ’, jew sa sagħtejn wara, kolazzjon standardizzat.
Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
Għoti konkomitanti ta ’ alendronate mal- kafè jew meraq tal- larinġ naqqas il - bijodisponibiltà b’ bejn wieħed u ieħor 60%.
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%).
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%).
Distribution Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/ kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine.
Firxa Studji fil- firien urew li alendronate jinfirex għal ftit tal- ħin fit- tessuti rotob wara l- għoti minn ġol- vina ta ’ 1 mg/ kg imma mbagħad huwa malajr mferrex mill- ġdid fl- għadam jew eliminat fl- awrina.
The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Il- volum ta ’ distribuzzjoni fi stat fiss medju, esklussivament mill- għadam, huwa ta ’ l- anqas 28 litru fil- bnedmin.
Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ ml).
Konċentrazzjonijiet ta ’ alendronate fil- plażma wara dożi terapewtiċi orali huma baxxi wisq għal osservanza analitika (< 5 ng/ ml).
Protein binding in human plasma is approximately 78%.
Irbit mal- proteina fil- plażma umana huwa ta ’ bejn wieħed u ieħor 78%.
Biotransformation There is no evidence that alendronate is metabolised in animals or humans.
Bijotrasformazzjoni M’ hemm l- ebda evidenza li alendronate huwa metabolizzat fl- annimali jew fil- bnedmin.
Elimination Following a single intravenous dose of [14C]alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Eliminazzjoni Wara doża waħdanija minn ġol- vina ta ’ [14C] alendronate, madwar 50% tar- radjuattività kienet eliminata fl- awrina fi żmien 72 siegħa u ftit li xejn radjuattività ma kienet rikoverata fl- ippurgar.
Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/ min, and systemic clearance did not exceed 200 ml/ min.
Wara doża waħdanija minn ġol- vina ta ’ 10 mg, l- eliminazzjoni renali ta ’ alendronate kienet 71 ml/ min, u l - eliminazzjoni sistemika ma qabżitx 200 ml/ min.
Plasma concentrations fell by more than 95% within six hours following intravenous administration.
Il- konċentrazzjonijiet fil- plażma waqgħu b’ aktar minn 95% fi żmien sitt sigħat wara l- għoti ġol- vina.
The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Il- half- life terminali fil- bnedmin hija meqjusa li taqbez l- għaxar snin, u tirrifletti ħelsien minn ġol- iskeletru.
Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not anticipated to interfere with the excretion of other medicinal products by those systems in humans.
Alendronate mhuwiex eliminat permezz ta ’ sistemi aċidiċi jew bażiċi mill- kliewi tal- firien, u għalhekk mhuwiex antiċipat li jtellef l - eliminazzjoni ta ’ prodotti mediċinali oħrajn minn dawn is- sistemi fil- bnedmin.
Absorption In healthy adult subjects (males and females), following administration of FOSAVANCE after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng• hr/ ml.
Assorbiment Wara l- għoti ta ’ FOSAVANCE 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- 120 hrs) għal
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.
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.
The bioavailability of the 2800 IU vitamin D3 in FOSAVANCE is similar to 2800 IU vitamin D3 administered alone.
Il- bijodisponibiltà tal- 2800 IU vitamina D3 f’ FOSAVANCE hija simili għal 2800 IU D3 mogħtija waħeda.
Distribution Following absorption, vitamin D3 enters the blood as part of chylomicrons.
Firxa Wara l- assorbiment, il- vitamina D3 tidħol fid- demm bħala parti miċ- chylomicrons.
Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form.
Il- vitamina D3 hija distribwita malajr l- aktar fil- fwied fejn tgħaddi minn metaboliżmu għal 25- hydroxyvitamin D3, il - forma ta ’ ħażna prinċipali.
Lesser amounts are distributed to adipose and muscle tissue and stored as vitamin D3 at
Ammonti aktar żgħar huma distribwiti lit- tessuti tax- xaħam u tal- muskoli u maħżuna bħala vitamina D3 f’ dawn is- siti għal tnixxija aktar tard għal ġoċ- ċirkulazzjoni.
Circulating vitamin D3 is bound to vitamin D-binding protein.
Il- vitamina D3 li tkun qed tiċirkola hija marbuta mal- proteina tal- vitamina D.
Biotransformation Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1,25-dihydroxyvitamin D3, which represents the biologically active form.
Bijotrasformazzjoni Il- vitamina D3 hija malajr metaboliżżata b’ hydroxylation fil- fwied għal 25- hydroxyvitamin D3, u sussegwentament metaboliżżata fil- kilwa għal 1, 25- dihydroxyvitamin D3, li tirrapreżenta l- forma bijoloġika attiva.
Further hydroxylation occurs prior to elimination.
Aktar idrosilazzjoni sseħħ qabel l- eliminazzjoni.
A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.
Perċentwali żgħir ta ’ vitamina D3 issirilha glucuronidation qabel l- eliminazzjoni.
Elimination When radioactive vitamin D3 was administered to healthy subjects, the mean urinary excretion of radioactivity after 48 hours was 2.4%, and the mean faecal excretion of radioactivity after 4 days was 4.9%.
Eliminazzjoni Meta ngħatat il- vitamina D3 radjuattiv lil suġġetti f’ saħħithom, l- eliminazzjoni medja fl- awrina tar - radjuattività wara 48 siegħa kienet ta '2. 4%, u l- eliminazzjoni medja tar- radjuattività fl- ippurgar wara 4 ijiem kienet ta' 4. 9%.
In both cases, the excreted radioactivity was almost exclusively as metabolites of the parent.
Fiż- żewġ każijiet, ir- radjuattività eliminata kienet kważi esklusivament bħala metaboliti tal- ġenitur.
The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/ 2800 IU) is approximately 24 hours.
Il- half- life medja ta ’ vitamina D3 fis- serum wara doża orali ta ’ FOSAVANCE (70 mg/ 2800 IU) hija madwar 24 siegħa.
Characteristics in patients Preclinical studies show that alendronate that is not deposited in bone is rapidly excreted in the urine.
Karatteristiċi fil- pazjenti Studji ta ’ qabel l- użu kliniku juru li alendronate li mhux depożitat fl- għadam huwa malajr eliminat fl - awrina.
No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/ kg in animals.
L- ebda evidenza ta ’ saturazzjoni tat- teħid fl- għadam ma nstabet wara ddożar kroniku b’ dożi kumulattivi mogħtija minn ġol- vina sa 35 mg/ kg fl- annimali.
Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function.
Għalkemm m’ hemm l- ebda informazzjoni klinika disponibbli, huwa probbabli li, bħal fl- annimali, l- eliminazzjoni ta ’ alendronate mill- kilwa tkun mnaqqsa f’ pazjenti b’ funzjoni renali indebolita.
Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Għaldaqstant, xi akkumulazzjoni akbar ta ’ alendronate fl- għadam tista ’ tkun mistennija f’ pazjenti b’ funzjoni renali mxekkla (ara sezzjoni 4. 2).
Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted.
Ma saru ebda studji mhux kliniċi b' kombinazzjoni ta 'alendronate u colecalciferol.
Alendronate Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Alendronate Informazzjoni li mhux kliniċi magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Studies in rats have shown that treatment with alendronate during pregnancy was associated with dystocia in dams during parturition which was related to hypocalcaemia.
Fi studji fuq il- firien urew li trattament b’ alendronate waqt it- tqala kien assoċjat ma ’ distoċja f’ firien nisa waqt it- twelid li kien relatat ma ’ ipokalċemija.
In studies, rats given high doses showed an increased incidence of incomplete foetal ossification.
Fi studji, firien li ngħataw dożi għoljin urew inċidenza akbar ta ’ ossifikazzjoni fetali mhux kompluta.
The relevance to humans is unknown.
Ir- relevanza għal bniedem għadu mhux magħruf.
Colecalciferol At doses far higher than the human therapeutic range, reproductive toxicity has been observed in animal studies.
Colecalciferol F' dożi li huma ferm ogħla mill- medda terapewtika tal- bniedem, ġiet osservata tossiċità riproduttiva fi studji fuq l- annimali.
Microcrystalline cellulose (E460) Lactose anhydrous Medium chain triglycerides Gelatin Croscarmellose sodium Sucrose Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Microcrystalline cellulose (E 460) Lactose anhydrous
10 6.2 Incompatibilities
10 Medium chain triglycerides Gelatin Croscarmellose sodium Sucrose Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Not applicable.
6. 2 Inkompatibilitajiet
6.3 Shelf life
Ma jgħoddx f’ dan il- każ.
18 months.
18- il xahar.
Store in the original blister in order to protect from moisture and light.
Żomm fil- folja oriġinali sabiex tipproteġi mill- umdità u d- dawl.
Wallet with sealed aluminium/ aluminium blisters, in cartons containing 2 (1 wallet x 2 tablets), 4 (1 wallet x 4 tablets), 6 (3 wallets x 2 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets.
Kartiera b' folji ta 'l- aluminju/ aluminju siġillati, f' kartun li fihom 2 (1 kartiera x 2 pilloli), 4 (1 kartiera x 4 pilloli), 6 (3 kartieri x 2 pilloli), 12 (3 kartieri x 4 pilloli) jew 40 (10 kartieri x 4 pilloli) pillola.
MARKETING AUTHORISATION HOLDER(S)
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
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 EU/ 1/ 05/ 310/ 005 – 40 tablets
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 EU/ 1/ 05/ 310/ 005 - 40 pillola
24 August 2005
24 ta ’ Awissu 2005
FOSAVANCE 70 mg/ 5600 IU tablets
FOSAVANCE 70 mg/ 5600 IU pilloli
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3).
Kull pillola fiha 70 mg alendronic acid bħala alendronate sodium trihydrate u 140 mikrogramma (5600 IU) colecalciferol (vitamina D3).
Each tablet contains 63 mg lactose anhydrous and 16 mg sucrose.
Kull pillola fiha 63 mg lactose anhydrous u 16 mg sucrose.
Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270 'on the other.
Pilloli ta ’ għamla rettangolari modifikata, ta ’ lewn abjad għal abjad fil- griż, immarkati b’ kontorn ta ’ immaġni ta ’ għadma fuq naħa, u '270' fuq in- naħa l- oħra.
Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin D supplementation and are at risk of vitamin D insufficiency.
Għat- trattament ta 'l- osteoporożi ta' wara l- menopawsa f' pazjenti li m’ humiex qed jirċievu s - supplimentazzjoni tal- vitamina D u li huma f’ riskju ta ’ insuffiċjenza ta ’ vitamina D.
• Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
13 • 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.
12 • Patients should not lie down for at least 30 minutes after taking FOSAVANCE.
• Il- pazjenti m' għandhomx jimteddu għal talanqas 30 minuta wara li jieħdu FOSAVANCE.
• 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).
The equivalence of intake of 5600 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 800 IU has not been studied.
L- ekwivalenza ta ’ teħid ta ’ 5600 IU ta ’ vitamina D3 kull ġimgħa f’ FOSAVANCE mad- doża ta ’ kuljum ta ’ 800 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 ta ’ l- effikaċja jew tas- sigurtà ta 'alendronate b’ rabta ma ’ l- età.
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 jieħdu alendronate wara li jiżviluppaw sintomi suġġestivi ta ’ irritazzjoni esofaġika.
13 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.
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).
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).
15 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).
14 Excipients This medicinal product contains lactose and sucrose.
Dan il- prodott mediċinali fih il- lactose u s- sucrose.
No other clinically significant interactions with medicinal products are anticipated.
L- ebda interazzjoni klinikament sinjifikanti ma ’ prodotti mediċinali ta 'sinifikat kliniku ma hija mistennija.
However, there is no information to indicate that FOSAVANCE affects a patient’ s ability to drive or operate machines.
Madankollu, mhemmx informazzjoni li tindika li FOSAVANCE jaffettwa l- ħila ta 'pazjent biex issuq jew iħaddem magni.
4.8 Undesirable effects
16 4. 8 Effetti mhux mixtieqa
15 Nervous system disorders:
Komuni: uġigħ ta ’ ras Disturbi fis- sistema nervuża:
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:
Ear and labyrinth disorders:
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda Disturbi muskolu - skeltrali u tal- connective tissue:
Skin and subcutaneous tissue disorders:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata:
Osteonecrosis of the jaw has been reported in patients treated by
alopesja Osteonekrosi tax- xedaq ġiet irrapportata f’ pazjenti ttrattati b’ bisphosphonates.
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.
General disorders and asthenia, peripheral oedema administration site conditions:
17
Laboratory test findings 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.
Eżitu tat- testijiet fil- laboratorju Fi studji kliniċi, tnaqqis mhux sintomatiku, ħafif u għaddien fil- kalċju u l- fosfat fis- serum kienu osservati f’ madwar18% u 10%, rispettivament, ta ’ pazjenti li qed jieħdu alendronate 10 mg/ kuljum kontra bejn wieħed u ieħor 12% u 3% ta ’ dawk li qed jieħdu plaċebo.
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.
Madankollu, l- inċidenzi ta ’ tnaqqis fil- kalċju fis- serum għal < 8. 0 mg/ dl (2. 0 mmol/ l) u l- fosfat fis- serum għal ≤ 2. 0 mg/ dl (0. 65 mmol/ l) kienu simili fiż- żewġ gruppi tat- trattament.
16 4.9 Overdose
4. 9 Doża eċċessiva
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.
18 dgħjufija tal- muskoli prossimali u osteomalaċja, li tkompli żżid ir- riskju ta ’ waqgħat u fratturi f’ individwi osteoporotiċi.
FOSAVANCE studies The effect of the lower dose 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
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.
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).
The effect of the lower dose of FOSAVANCE (alendronate 70 mg/ vitamin D3 2800 IU) plus an additional 2800 IU Vitamin D3 for a total of 5600 IU (the amount of vitamin D3 in the higher dose of FOSAVANCE) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women.
L- effett ta ’ l- anqas doża qawwija ta ’ FOSAVANCE (alendronate 70 mg/ vitamina D3 2800 IU) flimkien ma ’ 2800 IU addizzjonali ta ’ Vitamina D3 għal total ta ’ 5600 IU (l- ammont ta Vitamina D3 fid - doża l- aktar qawwija ta ’ FOSAVANCE) darba fil- ġimgħa ġie muri fi studju ta ’ estensjoni, ta ’ 24 ġimgħa, li rreġistra 619- il mara ta ’ wara l- menopawsa bl- osteoporożi.
Patients in the Vitamin D3 2800 group received FOSAVANCE (70 mg/ 2800 IU) (n=299) and patients in the Vitamin D3 5600 group received FOSAVANCE (70 mg/ 2800 IU) plus an additional 2800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
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 ’ 2800 IU addizzjonali ta ’ Vitamina D3 (n=309) darba fil- ġimgħa; supplimenti ta ’ vitamina D addizzjonali kienu permessi.
After 24-weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher in the Vitamin D3 5600 group (69 nmol/ l [27.6 ng/ ml]) than in the Vitamin D3 2800 group (64 nmol/ l [25.5 ng/ ml]).
Wara 24 ġimgħa ta ’ kura, il- livelli medji ta ’ 25- hydroxyvitamin D fis- serum kienu sinifikattivament 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]).
The percentage of patients with vitamin D insufficiency was 5.4% in the Vitamin D3 2800 group vs.
Il- perċentwal ta ’ pazjenti b’ insuffiċjenza ta ’ vitamina D kien 5. 4% fil- grupp tal- Vitamina D3 2800 vs.
3.2% in the Vitamin D3 5600 group through the 24-week extension.
3. 2% fil- grupp tal- Vitamina D3 5600 matul l- estensjoni ta ’ 24 ġimgħa.
The percentage of patients with vitamin D deficiency was 0.3% in the Vitamin D3 2800 group vs. zero in the Vitamin D3 5600 group.
Il - perċentwal ta ’ pazjenti b’ defiċjenza ta ’ vitamina D kien 0. 3% fil- grupp tal- Vitamina D3 2800 vs. żero fil- grupp tal- Vitamina D3 5600.
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Ma kien hemm l- ebda differenza bejn il- gruppi tat- trattament fil- medji tal- kalċju u tal- fosfat fis- serum, jew fil- kalċju fl- awrina ta ’ 24 siegħa.
The percentage of patients with hypercalciuria at the end of the 24-week extension was not statistically different between treatment groups.
Il- perċentwal ta ’ pazjenti b’ iperkalċurja fi tmiem l- estensjoni ta ’ 24 ġimgħa ma kienx statistikament differenti bejn il- gruppi tat - trattament.
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.
19 Fl- istudji ta ’ l- effikaċja fil- bidu, żjidiet fil- BMD medja b ’ alendronate 10 mg/ kuljum relattivament ma ’ plaċebo fi żmien tliet snin kienu 8. 8%, 5. 9% u 7. 8% fis- sinsla, fl- għonq femurali u fit - trochanter, rispettivament.
In this study alendronate daily reduced the incidence of ≥ 1 new
Studju ta ’ tliet snin fuq 2, 027 pazjenti li kellhom ta ’ l- anqas frattura (ta ’ kompressjoni) vertebrali waħda fil- linja bażi ta 'riferiment.
18 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
F’ dan l- istudju alendronate mogħti kuljum naqqas l - inċidenza ta’ ≥1 frattura vertebrali ġdida b ’ 47% (alendronate 7. 9% kontra plaċebo 15. 0%).
The alendronate component in the FOSAVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Il- komponent alendronate fil- pillola kombinata FOSAVANCE (70 mg/ 5600 IU) huwa bijoekwivalenti għal pillola ta ’ 70 mg alendronate.
Biotransformation There is no evidence that alendronate is metabolised in animals or humans.
20 Bijotrasformazzjoni M’ hemm l- ebda evidenza li alendronate huwa metabolizzat fl- annimali jew fil- bnedmin.
Absorption In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/ 5600 IU after an overnight fast and two hours before a meal, the mean area under the serum- concentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng• hr/ ml.
Assorbiment Wara l- għoti ta ’ FOSAVANCE 70 mg/ 5600 IU 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.
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.
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) kien ta '10. 6 sigħat.
The bioavailability of the 5600 IU vitamin D3 in FOSAVANCE is similar to 5600 IU vitamin D3 administered alone.
Il- bijodisponibiltà tal- 5600 IU vitamina D3 f’ FOSAVANCE hija simili għal 5600 IU D3 mogħtija waħedha.
Lesser amounts are distributed to adipose and muscle tissue and stored as vitamin D3 at these sites for later release into the circulation.
Ammonti aktar żgħar huma distribwiti lit- tessuti tax- xaħam u tal- muskoli u maħżuna bħala vitamina D3 f’ dawn is- siti għal tnixxija aktar tard għal ġoċ- ċirkulazzjoni.
5.3 Preclinical safety data
21 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Microcrystalline cellulose (E460) Lactose anhydrous Medium chain triglycerides Gelatin Croscarmellose sodium Sucrose Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Microcrystalline cellulose (E 460) Lactose anhydrous Medium chain triglycerides Gelatin Croscarmellose sodium Sucrose Colloidal silicon dioxide Magnesium stearate (E572) Butyl hydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Wallet with sealed aluminium/ aluminium blisters, in cartons containing 2 (1 wallet x 2 tablets), 4 (1 wallet x 4 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets.
Kartiera b' folji ta 'l- aluminju/ aluminju siġillati, f' kartun li fihom 2 (1 kartiera x 2 pilloli), 4 (1 kartiera x 4 pilloli), 12 (3 kartieri x 4 pilloli) jew 40 (10 kartieri x 4 pilloli) pillola.
EU/ 1/ 05/ 310/ 006 – 2 tablets EU/ 1/ 05/ 310/ 007 – 4 tablets EU/ 1/ 05/ 310/ 008 – 12 tablets EU/ 1/ 05/ 310/ 009 – 40 tablets
EU/ 1/ 05/ 310/ 006 – 2 pilloli EU/ 1/ 05/ 310/ 007 – 4 pilloli EU/ 1/ 05/ 310/ 008 – 12- il pillola EU/ 1/ 05/ 310/ 009 – 40 pillola
22 ANNEX II
23 ANNESS II
Via Complutense, 140 ES-28805 Alcalá de Henares Madrid, Spain
Via Complutense, 140 ES- 28805 Alcalá de Henares Madrid, Spanja
The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2 ippreżentata fis- Sezzjoni 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qed taħdem qabel u waqt li l- prodott ikun fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni 1 tal- Pjan tal- Ġestjoni tar- Riskju (RMP) ippreżentaat fis- Sezzjoni 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mill - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
B’ mod konformi mal- Linja gwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għall- użu mill- bniedem, l- RMP aġġornat għandu jiġi ippreżentat fl- istess żmien tar - Rapport Perjodiku ta ’ Aġġornament tas- Sigurtà (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, fuq il- Pjan tal- Farmakoviġilanza jew fuq l- attivitajiet ta ’ minimizzazzjoni tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) • Fuq talba ta ’ l- EMEA
25 A.
25 ANNESS III
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA 'BARRA – KARTUNA 1, 3 jew 10 GĦAL PAKKETT MILWI TLIET DARBIET TA' 2 jew 4 PILLOLI
FOSAVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
FOSAVANCE 70 mg/ 2800 IU pilloli Alendronic acid bħala alendronate sodium trihydrate/ colecalciferol
Each tablet contains:
Kull pillola fiha:
70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D3.).
70 mg alendronic acid bħala alendronate sodium trihydrate u 70 mikrogramma (2800 IU) colecalciferol (vitamina D3).
Also contains: lactose anhydrous and sucrose.
Fih ukoll: lactose anhydrous u sucrose.
See package leaflet for further information.
Ara l- fuljett ta 'tagħrif għal aktar tagħrif.
2 tablets 4 tablets 6 tablets 12 tablets 40 tablets
2 pilloli 4 pilloli 6 pilloli 12- il pillola 40 pillola
For oral use To be taken once weekly, on the same day each week.
Għandu jittieħed darba fil- ġimgħa, fl- istess jum kull ġimgħa.
Once weekly
Darba fil- ġimgħa
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) EU/ 1/ 05/ 310/ 005 (40 tablets)
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) EU/ 1/ 05/ 310/ 005 (40 pillola)
28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
IMMEDIATE PACKAGING – TRIFOLD PACK OF 2 or 4 TABLETS
PAKKETT LI JMISS MAL- PRODOTT – PAKKETT MILWI TLIET DARBIET B' 2 jew 4 PILLOLI
2 tablets 4 tablets
2 pilloli 4 pilloli
For oral use.
Jittieħed mill- ħalq.
Important information
Tagħrif importanti
How to take FOSAVANCE tablets
Kif għandek tieħu l- pilloli FOSAVANCE
Take one tablet once a week.
Ħu pillola waħda darba fil- ġimgħa.
Choose the day of the week that best fits your schedule.
Agħżel il- jum tal- ġimgħa li joqgħod l- aħjar fl- iskeda tiegħek.
When you get out of bed on the day you have chosen, and before taking your first food, drink or other medicines, swallow (do not chew or suck) one FOSAVANCE tablet with a full glass of water (not mineral water).
Meta tqum mis- sodda fil- jum magħżul, u qabel ma tieħu l- ewwel ikla, xarba jew mediċina oħra, ibla '(m' għandekx tomgħod jew terda') pillola waħda ta 'FOSAVANCE ma tazza mimlija bl- ilma (mhux ilma minerali).
Continue your morning activities.
Issokta bl- attivitajiet tal- ġurnata tiegħek.
You can sit, stand or walk – just stay fully upright.
Tista 'toqgħod bilqieghda, bilwieqfa jew timxi – oqgħod biss wieqaf.
Don’ t lie down, eat, drink or take other medicines for at least 30 minutes.
M' għandekx la timtedd, la tiekol, la tixrob u lanqas tieħu mediċini oħra għal ta 'lanqas 30 minuta.
Do not lie down until after your first food of the day.
M' għandekx timtedd sa wara li tkun ħadt l- ewwel ikla tal- jum.
Remember, take FOSAVANCE once each week on that same day for as long as your doctor prescribes it.
Tinsiex, ħu FOSAVANCE darba fil- ġimgħa fl- istess jum għal kemm it- tabib jibqa 'jippriskrivihulek.
If you miss a dose, take only one FOSAVANCE tablet on the morning after you remember.
Jekk tinsa tieħu xi doża, hu pillola waħda ta 'FOSAVANCE fl- għodwa wara li tiftakar.
Do not take two tablets on the same day.
M' għandekx tieħu żewġ pilloli fl- istess jum.
Return to taking one tablet once a week, as originally scheduled on your chosen day.
Irritorna għall- iskeda normali ta 'pillola waħda fil- ġimgħa fil- jum magħżul.
There is important additional information about how to take FOSAVANCE in the enclosed package leaflet.
Hemm tagħrif addizzjonali importanti dwar kif għandek tieħu FOSAVANCE fil- fuljett li jinsab fil - pakkett.
Please read it carefully.
Jekk jogħġbok aqrah sew.
29 Take one tablet once a week
30 Ħu pillola waħda darba fil- ġimgħa
Mark the day of the week that best fits your schedule:
Immarka l- jum tal- ġimgħa li joqgħod l- aħjar fl- iskeda tiegħek:
MON FRI TUE SAT WED SUN THU
TNE ĠIM TLI SIB ERB ĦAD ĦAM
WEEK 1.
ĠIMGĦA 1.
Date: ____ WEEK 2.
Data: ____ ĠIMGĦA 2.
Date: _____ WEEK 3.
Data: _____ ĠIMGĦA 3.
Date: ____ WEEK 4.
Data: ____ ĠIMGĦA 4.
Date: _____ TIME TO REFILL
Data: _____ ŻMIEN BIEX TERĠA 'IĠĠIB
For your convenience, place a sticker on your calendar each week as a reminder to take your FOSAVANCE.
Għal konvenjenza tiegħek, qiegħed stiker fuq il- kalendarju tiegħek biex tgħinek tiftakar biex tieħu FOSAVANCE.
FOSAVANCE WEEK 1 FOSAVANCE WEEK 2 FOSAVANCE WEEK 3 FOSAVANCE WEEK 4 TIME TO REFILL
FOSAVANCE ĠIMGĦA 1 FOSAVANCE ĠIMGĦA 2 FOSAVANCE ĠIMGĦA 3 FOSAVANCE ĠIMGĦA 4 ŻMIEN BIEX TERĠA 'IĠĠIB
To remove, push tablets through from this side.
Sabiex toħroġhom, imbotta l- pilloli minn din in- naħa.
To remove, push tablets through from other side.
Sabiex toħroġhom, imbotta l- pilloli min- naħa l- oħra.
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) EU/ 1/ 05/ 310/ 005 (40 tablets)
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 pilloli) EU/ 1/ 05/ 310/ 005 (40 pillola)
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA - KARTUNA GĦAL PAKKETT MILWI 1, 3 jew 10 DARBIET TA '2 jew 4 PILLOLI
FOSAVANCE 70 mg/ 5600 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
FOSAVANCE 70 mg/ 5600 IU pilloli Alendronic acid bħala alendronate sodium trihydrate/ colecalciferol
70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3.).
70 mg alendronic acid bħala alendronate sodium trihydrate u 140 mikrogramma (5600 IU) colecalciferol (vitamina D3).
2 tablets 4 tablets 12 tablets 40 tablets
2 pilloli 4 pilloli 12- il pillola 40 pillola
Store in the original blister in order to protect from moisture and light.
Żomm fil- folja oriġinali sabiex tilqa ’ mill- umdità u d- dawl.
EU/ 1/ 05/ 310/ 006 (2 tablets) EU/ 1/ 05/ 310/ 007 (4 tablets) EU/ 1/ 05/ 310/ 008 (12 tablets) EU/ 1/ 05/ 310/ 009 (40 tablets)
EU/ 1/ 05/ 310/ 006 (2 pilloli) EU/ 1/ 05/ 310/ 007 (4 pilloli) EU/ 1/ 05/ 310/ 008 (12- il pillola) EU/ 1/ 05/ 310/ 009 (40 pillola)
33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
34 Take one tablet once a week
35 Ħu pillola waħda darba fil- ġimgħa
Date: ____ WEEK 4.
Data: _____ ĠIMGĦA 4.
Date: _____ TIME TO REFILL
Data: _____
37 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina, anke jekk din hija riċetta ripetuta.
- It is particularly important to understand the information in section 3.
- Huwa importanti ħafna li tifhem l- informazzjoni f' sezzjoni 3.
HOW TO TAKE
KIF GĦANDEK TIEĦU
FOSAVANCE, before taking this medicine.
FOSAVANCE, qabel tieħu din il- mediċina.
2.
X’ inhu FOSAVANCE u għalxiex jintuża 2.
3.
Qabel ma tieħu FOSAVANCE 3.
4.
Kif għandek tieħu FOSAVANCE 4.
5 6.
Effetti sekondarji li jista ’ jkollu 5 Kif taħżen FOSAVANCE 6.
WHAT FOSAVANCE IS AND WHAT IT IS USED FOR
X’ INHU FOSAVANCE U GĦALXIEX JINTUŻA
What is FOSAVANCE?
X' inhu FOSAVANCE?
FOSAVANCE is a tablet containing the two active substances, alendronate sodium trihydrate and colecalciferol known as vitamin D3.
FOSAVANCE huwa pillola kombinata li fiha ż- żewġ sustanzi attivi, alendronate sodium trihydrate u colecalciferol magħruf bħala vitamina D3.
What is alendronate?
X' inhu alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Alendronate jappartjeni għal grupp ta 'mediċini mhux ormonali li jissejħu bisphosphonates.
Alendronate prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone.
Alendronate jipprevjeni t- telf ta 'l- għadam li jseħħ f' nisa wara li jkunu għaddew mill- menopawsa, u jgħinhom jibnu mill- ġdid l- għadam.
It reduces the risk of spine and hip fractures.
Huwa jnaqqas ir- riskju ta 'ksur vertebrali u tal- ġenbejn.
What is vitamin D?
X' inhi vitamina D?
Vitamin D is an essential nutrient, required for calcium absorption and healthy bones.
Il- vitamin D hija nutrijent essenzjali, meħtieġa għall- assorbiment tal- kalċju u l- għadam b' saħħtu.
The body can only absorb calcium properly from our food if it has enough vitamin D.
Il - ġisem jista 'biss jassorbi l- kalċju sew mill- ikel tagħna jekk ikollu biżżejjed vitamina D.
Very few foods contain vitamin D.
Ftit ikel biss fih il- vitamina D.
The main source is through exposure to summer sunlight, which makes vitamin D in our skin.
Is- sors ewlieni hu permezz ta 'espożizzjoni għad dawl tax- xemx fis- sajf li jagħmel il - vitamina D fil- ġilda tagħna.
As we get older our skin makes less vitamin D.
Kif nikbru fl- età il- ġilda tagħna tagħmel anqas vitamina D.
Too little vitamin D may lead to bone loss and osteoporosis.
Nuqqas ta 'vitamina D jista' jwassal għat- telf ta 'għadam u osteoporożi.
Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a greater risk of fractures.
Nuqqas serju ta 'vitamina D jista' jwassal għal indeboliment muskolari li jista 'jwassal għal waqgħat u għal riskju akbar ta' ksur.
What is FOSAVANCE used for?
Għalxiex jintuża FOSAVANCE?
Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
It- tabib tiegħek ippreskriva FOSAVANCE sabiex jittratta l- osteoporożi tiegħek u minħabba li inti f' riskju minħabba nuqqas ta 'vitamina D.
FOSAVANCE reduces the risk of spine and hip fractures.
FOSAVANCE inaqqas ir- riskju ta 'ksur vertebrali u tal - ġenbejn.
FOSAVANCE is a once weekly treatment.
FOSAVANCE huwa trattament li jittieħed darba fil- ġimgħa.
What is osteoporosis?
X' inhi l- osteoporożi?
Osteoporosis is a thinning and weakening of the bones.
L- osteoporożi hija it- tidjiq u d- dgħjufija ta 'l- għadam.
It is common in women after the menopause.
Hija komuni fin- nisa wara l- menopawsa.