natgillin/translations-raw huggingface dataset:
Styrke 70 mg/ 2800 IE 70 mg/ 2800 IE 70 mg/ 2800 IE 70 mg/ 2800 IE 70 mg/ 2800 IE 70 mg / 5600 IE 70 mg / 5600 IE 70 mg / 5600 IE 70 mg / 5600 IE
70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU
Lægemiddelform Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Administrationsvej Til oral anvendelse Til oral anvendelse Til oral anvendelse Til oral anvendelse Til oral anvendelse Til oral anvendelse Til oral anvendelse Til oral anvendelse Til oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage 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)
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)
Pakningsstørrelse 2 tabletter 4 tabletter 6 tabletter 12 tabletter 40 tabletter 2 tabletter 4 tabletter 12 tabletter 40 tabletter
2 tablets 4 tablets 6 tablets 12 tablets 40 tablets 2 tablets 4 tablets 12 tablets 40 tablets
FOSAVANCE 70 mg/ 2800 IE, tabletter
FOSAVANCE 70 mg/ 2800 IU tablets
Den anbefalede dosis er en FOSAVANCE tablet én gang ugentligt.
The recommended dosage is one FOSAVANCE tablet once weekly.
• FOSAVANCE skal først tages, efter patienten er stået op, og skal tages sammen med et helt glas postevand (mindst 200 ml).
• FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200ml or 7fl. oz.).
2 • Patienten må ikke ligge ned, før dagens første måltid er indtaget, hvilket bør være mindst 30 minutter efter indtagelse af tabletten.
• Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
• Patienten må ikke ligge ned de første 30 minutter efter indtagelsen af FOSAVANCE.
• Patients should not lie down for at least 30 minutes after taking FOSAVANCE.
• FOSAVANCE må ikke tages ved sengetid eller før patienten står op.
2 • FOSAVANCE should not be taken at bedtime or before arising for the day.
Ækvivalensen mellem indtagelse af 2800 IE D3 - vitamin ugentligt i FOSAVANCE og daglig dosering af D- vitamin 400 IE er ikke undersøgt.
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.
På grund af manglende erfaring anbefales FOSAVANCE ikke til patienter med nyreinsufficiens, hvor kreatinin - clearance er < 35 ml/ min.
FOSAVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min, due to lack of experience.
FOSAVANCE er ikke undersøgt hos børn og unge og bør derfor ikke anvendes til dem.
FOSAVANCE has not been studied in children and adolescents and therefore should not be given to them.
Risikoen for alvorlige, esophageale bivirkninger synes større hos patienter, der ikke tager alendronat som foreskrevet, og/ eller som fortsætter med at tage alendronat efter at have udviklet symptomer, der
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.
Kæbeosteonekrose, som normalt er associeret med tandudtrækning og/ eller lokal infektion (inklusive osteomyelitis), er rapporteret hos cancerpatienter, som modtagerbehandlingsregimer, inklusive primært intravenøst administrerede bisphosphonater.
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.
Den behandlende læges kliniske vurdering bør være vejledende for den enkelte patients behandlingsplan og være baseret på individuel fordel/ risiko vurdering.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
4. 2).
FOSAVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min (see section 4.2).
4. 3).
Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
Andre lidelser, som påvirker mineralmetabolismen (såsom D- vitaminmangel og hypoparathyroidisme), skal også behandles effektivt, før behandling med FOSAVANCE initieres.
Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting FOSAVANCE.
Indholdet af D- vitamin i FOSAVANCE er ikke velegnet til opretning af D- vitaminmangel.
The content of vitamin D in FOSAVANCE is not suitable for correction of vitamin D deficiency.
Hos patienter med disse lidelser bør serumkalcium og symptomer på hypokalcæmi monitoreres under behandling med FOSAVANCE.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE.
4 Colecalciferol D3- vitamin kan øge sværhedsgraden af hyperkalcæmi og/ eller hyperkalciuri, når det gives til patienter med sygdomme, der er forbundet med ureguleret overproduktion af calcitriol (f. eks. leukæmi, lymphoma, sarcoidosis).
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).
Hjælpestoffer Dette lægemiddel indeholder lactose og saccharose.
4 Excipients This medicinal product contains lactose and sucrose.
FOSAVANCE er kun beregnet til anvendelse for postmenopausale kvinder, og bør derfor ikke anvendes under graviditet eller af ammende kvinder.
FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
Der er ikke tilstrækkelige data fra brug af FOSAVANCE til gravide kvinder.
There are no adequate data from the use of FOSAVANCE in pregnant women.
Der er imidlertid ingen information, der indikerer, at FOSAVANCE påvirker patientens evne til at køre bil eller betjene maskiner.
However, there is no information to indicate that FOSAVANCE affects a patient’ s ability to drive or operate machines.
Der er ikke identificeret nye bivirkninger for FOSAVANCE.
No additional adverse reactions have been identified for FOSAVANCE.
Øjne:
5 Nervous system disorders:
Mave- tarmkanalen:
Common: headache
Sjælden:
Eye disorders:
Sjælden:
Gastrointestinal disorders:
Udslæt, kløe, erythema.
Musculoskeletal and connective tissue disorders:
Sjælden:
Metabolism and nutrition disorders:
Udslæt med lysoverfølsomhed.
General disorders and administration site conditions:
Meget sjælden:
Immune system disorders:
Metabolisme og ernæring:
dizziness
Sjælden:
Ear and labyrinth disorders:
Immunsystemet:
vertigo
Sjælden:
Skin and subcutaneous tissue disorders:
Bisphosphonater, kombinationer ATC- kode:
Bisphosphonates, combinations, ATC code:
FOSAVANCE er en kombinationstablet indeholdende de to aktive substanser alendronatnatriumtrihydrat og colecalciferol (D3- vitamin).
FOSAVANCE is a combination tablet containing the two active substances alendronate sodium trihydrate and colecalciferol (vitamin D3).
7 Osteoporosis er defineret som knoglemineraltætheden (BMD) for columna spinalis eller hofte på 2, 5 standarddeviationer (SD) under middelværdien for en normal ung population eller som tidligere skørhedsfraktur uden hensyntagen til BMD.
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.
Gennemsnit, 56 nmol/ l [22, 3 ng/ ml]; variationsbredde, 22, 5- 225 nmol/ l [9- 90 ng/ ml]).
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]).
Patienterne fik den lavere styrke (70 mg/ 2800 IE) af FOSAVANCE (n=350) eller FOSAMAX UGETABLET (alendronat) 70 mg (n=332) én gang ugentligt; yderligere D - vitamin tilskud var ikke tilladt.
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
Efter 15 ugers behandling var de gennemsnitlige serum 25 - hydroxyvitamin D niveauer signifikant højere (26%) i FOSAVANCE (70 mg/ 2800 IE) gruppen (56 nmol/ l [23 ng/ ml]) end i gruppen med alendronat alene (46 nmol/ l [18, 2 ng/ ml]).
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]).
Procentdelen af patienter med D- vitaminmangel (serum 25- hydroxyvitamin D < 37, 5 nmol/ l [< 15 ng/ ml]) var signifikant reduceret med 62, 5% med FOSAVANCE (70 mg/ 2800 IE) versus alendronat alene (henholdsvis 12% versus 32%) efter uge 15.
32%, respectively), through week 15.
Procentdelen af patienter med D- vitaminmangel (serum 25- hydroxyvitamin D < 22, 5 nmol/ l [< 9 ng/ ml]) var signifikant reduceret med 92% med FOSAVANCE (70 mg/ 2800 IE) versus alendronat alene (henholdsvis 1% versus 13%).
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).
I denne undersøgelse øgedes de gennemsnitlige 25- hydroxyvitamin D niveauer hos patienter med D - vitaminmangel ved baseline (25- hydroxyvitamin D, 22, 5 til 37, 5 nmol/ l [9 til < 15 ng/ ml]) fra 30 nmol/ l (12, 1 ng/ ml) til 40 nmol/ l (15, 9 ng/ ml) ved uge 15 i FOSAVANCE (70 mg/ 2800 IE) gruppen (n=75) og faldt fra 30 nmol/ l (12, 0 ng/ ml) ved baseline til 26 nmol/ l (10, 4 ng/ ml) ved uge 15 i gruppen med alendronat alene (n=70).
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).
I denne undersøgelse observeredes en signifikant forskel i en analyse 8 af subgruppen af osteoporotiske kvinder (37% af global population som havde osteoporose svarende til ovennævnte definition) i incidensen af hoftefrakturer (alendronat 1, 0% versus placebo 2, 2%, en reduktion på 56%) og i incidensen af ≥ 1 vertebral fraktur (2, 9% versus 5, 8%, en reduktion på 50%).
5.8%, a reduction of 50%).
Alendronatkomponenten i FOSAVANCE (70 mg/ 2800 IU) kombinationstabletten er bioekvivalent til alendronat i 70 mg tabletten.
The alendronate component in the FOSAVANCE (70 mg/ 2800 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Absorption Ved administration af FOSAVANCE efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum- koncentration- tid (AUC0- 120 timer) for D3- vitamin (ikke justeret for endogene D3- vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 296, 4 ng time/ ml.
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.
Biotilgængeligheden for 2800 IE D3- vitamin i FOSAVANCE er lig med 2800 IE D3- vitamin, administreret alene.
The bioavailability of the 2800 IU vitamin D3 in FOSAVANCE is similar to 2800 IU vitamin D3 administered alone.
24 timer.
The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/ 2800 IU) is approximately 24 hours.
EU/ 1/ 05/ 310/ 001 – 2 tabletter EU/ 1/ 05/ 310/ 002 – 4 tabletter EU/ 1/ 05/ 310/ 003 – 6 tabletter EU/ 1/ 05/ 310/ 004 – 12 tabletter EU/ 1/ 05/ 310/ 005 – 40 tabletter
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
FOSAVANCE 70 mg/ 5600 IE, tabletter
FOSAVANCE 70 mg/ 5600 IU tablets
Modificeret kapselformede, hvide/ beige tabletter, mærket med et omrids af en knogle på den ene side og ” 270 ” på den anden.
Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270 'on the other.
Den anbefalede dosis er én FOSAVANCE tablet en gang ugentligt.
The recommended dosage is one FOSAVANCE tablet once weekly.
12 • Patienten må ikke ligge ned de første 30 minutter efter indtagelsen af FOSAVANCE.
12 • Patients should not lie down for at least 30 minutes after taking FOSAVANCE.
• FOSAVANCE må ikke tages ved sengetid eller før patienten står op.
• FOSAVANCE should not be taken at bedtime or before arising for the day.
Patienterne skal have supplerende kalcium, hvis indtagelsen fra kosten ikke er tilstrækkelig (se pkt.
Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4)..
Ækvivalensen mellem indtagelse af 5600 IE D3- vitamin ugentligt i FOSAVANCE og daglig dosering af D- vitamin 800 IE er ikke undersøgt.
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.
En dental undersøgelse med hensigtsmæssig præventiv tandlægebehandling bør overvejes før behandling med biphosphonater hos patienter med samtidige risikofaktorer (f. eks. cancer, kemoterapi, strålebehandling, kortikosteroider, dårlig oral hygiejne, paradentose).
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).
På grund af alendronats positive effekt på øgning i knoglemineraltætheden, kan der opstå fald i serumkalcium og serumphosphat.
Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur.
FOSAVANCE er kun beregnet til anvendelse hos postmenopausale kvinder og bør derfor ikke anvendes under graviditet eller af ammende kvinder.
FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
[Almindelig( ≥1/ 100, < 1/ 10), ikke almindelig (≥1/ 1000, < 1/ 100), sjælden (≥1/ 10. 000, < 1/ 1000), meget sjælden (< 1/ 10. 000)].
[Common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1000), very rare (< 1/ 10,000)]
15
15 Nervous system disorders:
Nervesystemet:
Musculoskeletal,
Knogler, led, musk - ler og bindevæv:
Osteonecrosis of the jaw has been reported in patients treated by
Alopeci.
connective tissue and bisphosphonates.
Kæbeosteonekrose er rapporteret hos patienter, der er behandlet med bisphosphonater.
The majority of the reports refer to cancer patients, bone disorders:
Størstedelen af rapporterne refererer til cancerpa - tienter, men sådanne tilfælde har også været rapporteret for patienter, der er behandlet for osteoporose.
but such cases have also been reported in patients treated for osteoporosis.
Almene symptomer og reaktioner på administrationsste - det:
General disorders and asthenia, peripheral oedema administration site conditions:
Imidlertid var incidensen af fald i serumkalcium til < 8, 0 mg/ dl (2, 0 mmol/ l) og serumphosfat til ≤ 2, 0 mg/ dl (0, 65 mmol/ l) ens i begge behandlingsgrupper.
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.
16 Der er ingen specifik information vedrørende behandling af overdosering med alendronat.
16 4.9 Overdose
Bisphosphonater, kombinationer, ATC- kode:
Bisphosphonates, combinations, ATC code:
Alendronat Alendronatnatrium er et bisphosphonat, der hæmmer osteoklasters knogleresorption uden direkte effekt på knogleopbygningen.
Alendronate Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation.
D3- vitamin omdannes til 25- hydroxyvitamin D3 i leveren og lagres, indtil der er brug for det.
Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Den vigtigste funktion for 1, 25 dihydroxyvitamin D3 er at øge den intestinale absorption af både kalcium og phosphat såvel som at regulere serumkalcium, renal kalcium og phosphatudskillelsen, knogleopbygningen og knogleresorptionen.
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.
Gennemsnit, 56 nmol/ l [22, 3 ng/ ml]; variationsbredde, 22, 5- 225 nmol/ l [9- 90 ng/ ml]).
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]).
Patienterne fik den lavere styrke (70 mg/ 2800 IE) af FOSAVANCE (n=350) eller FOSAMAX UGETABLET (alendronat) 70 mg (n=332) én gang ugentligt; yderligere D- vitamin tilskud var ikke tilladt.
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
17 ng/ ml]).
17 D supplements were prohibited.
Procentdelen af patienter med D - vitaminmangel (serum 25- hydroxyvitamin D ≤ 22, 5 nmol/ l [≤9 ng/ ml]) var signifikant reduceret med 92% med FOSAVANCE (70 mg/ 2800 IE) versus alendronat alene (henholdsvis 1% versus 13%).
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).
I denne undersøgelse øgedes de gennemsnitlige 25- hydroxyvitamin D niveauer hos patienter med D - vitaminmangel ved baseline (25- hydroxyvitamin D, 22, 5 til 37, 5 nmol/ l [9 til < 15 ng/ ml]) fra 30 nmol/ l (12, 1 ng/ ml) til 40 nmol/ l (15, 9 ng/ ml) ved uge 15 i FOSAVANCE (70 mg/ 2800 IE) gruppen (n=75) og faldt fra 30 nmol/ l (12, 0 ng/ ml) ved baseline til 26 nmol/ l (10, 4 ng/ ml) ved uge 15 i gruppen med alendronat alene (n=70).
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).
Der var ingen forskel i middel serumkalcium, phosphat eller 24 timers urinkalcium mellem behandlingsgrupperne.
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Effekten af den lavere dose af FOSAVANCE (alendronat 70 mg/ D3- vitamin 2800 IE) plus yderligere 2800 IE D3- vitamin til i alt 5600 IE (mængden af D3- vitamin i den højere dose af FOSAVANCE) én gang ugentligt blev påvist i en 24 ugers ekstensionundersøgelse, der inkluderede 619 postmenopausale kvinder med osteoporose.
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.
Patienter i D3- vitamin 2800 gruppen fik FOSAVANCE (70 mg/ 2800 IE) (n=299), og patienter i D3- vitamin 5600 gruppen fik FOSAVANCE (70 mg/ 2800 IE) plus yderligere 2800 IE D3- vitamin (n=309) én gang ugentligt; yderligere D- vitamintilskud var tilladt.
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.
Efter 24 ugers behandling var de gennemsnitlige serum 25- hydroxyvitamin D niveauer signifikant højere i D3 - vitamin 5600 gruppen (69 nmol/ l [27, 6 ng/ ml] end i D3- vitamin 2800 gruppen (64 nmol/ l [25, 5 ng/ ml].
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]).
I denne undersøgelse reducerede alendronat 1 gang dagligt incidensen af ≥ 1 ny vertebral fraktur med 47% (alendronat 7, 9% versus placebo 15, 0%).
18 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
18 • FIT 2:
• FIT 2:
Alendronatkomponenten i FOSAVANCE (70 mg/ 5600 IU) kombinationstabletten er bioekvivalent til alendronat i 70 mg tabletten.
The alendronate component in the FOSAVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
19 gennemsnitlige tid til maksimal serumkoncentration (Tmax) var 10, 6 timer.
19 Colecalciferol
Biotilgængeligheden for 5600 IE D3- vitamin i FOSAVANCE er lig med 5600 IE D3- vitamin, administreret alene.
The bioavailability of the 5600 IU vitamin D3 in FOSAVANCE is similar to 5600 IU vitamin D3 administered alone.
Distribution Efter absorption går D3- vitamin ind i blodet som en del af chylomikronerne.
Distribution Following absorption, vitamin D3 enters the blood as part of chylomicrons.
20 Kolloid vandfri silica Magnesiumstearat (E572) Butylhydroxytoluen (E321) Modificeret majsstivelse Natriumaluminiumsilicat (E554)
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)
EU/ 1/ 05/ 310/ 006 – 2 tabletter EU/ 1/ 05/ 310/ 007 – 4 tabletter EU/ 1/ 05/ 310/ 008 – 12 tabletter EU/ 1/ 05/ 310/ 009 – 40 tabletter
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
FREMSTILLER( E) ANSVARLIG( E) FOR
CONDITIONS OF THE MARKETING AUTHORISATION
Indehaveren af markedsføringstilladelsen er forpligtet til at udføre studier og nye pharmacovigilance aktiviteter beskrevet i Pharmacovigilance planen i overensstemmelse med version 1 af Risk Management Plan (RMP) beskrevet i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse samt alle de efterfølgende RMP- opdateringer, aftalt med CHMP.
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.
Ifølge CHMP guideline om Risk Management System for lægemidler til human brug, bør de opdaterede RMP indsendes samtidig med den næste sikkerhedsopdateringsrapporter (PSUR).
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).
FOSAVANCE 70 mg/ 2800 IE tabletter Alendronsyre som alendronatnatriumtrihydrat/ colecalciferol
FOSAVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol