natgillin/translations-raw huggingface dataset:
Place the pen back in the refrigerator and contact your healthcare professional.
Položite peresnik nazaj v hladilnik in se obrnite na vašega zdravstvenega delavca.
Disposal of Pen Needles and Device Disposal of Pen Needles and FORSTEO Device • Before disposing of the FORSTEO device, be sure to remove the pen needle. • Dispose of your FORSTEO and used needles as directed by your healthcare professional. • Dispose of the device 28 days after first use.
Odstranjevanje igel peresnika in medicinskega pripomočka Odstranjevanje igel peresnika in medicinskega pripomočka
Other Important Notes • The FORSTEO contains 28 days of medication. • Do not transfer the medication into a syringe.
Pred odstranjevanjem medicinskega pripomočka FORSTEO zagotovite, da ste odstranili iglo peresnika.
28 • Write down your first injection date on a calendar. • Read and follow the instructions in the Information for the Patient leaflet for using medication. • Check the FORSTEO label to make sure you have the correct medication and that it has not expired. • Contact your healthcare professional if you notice any of the following:
Medicinski pripomoček zavrzite 28 dni po prvi uporabi.
- The FORSTEO appears damaged
Druga pomembna opozorila
- The medication is NOT clear, colourless and free of particles
Preverite nalepko FORSTEA za zagotovitev, da imate pravo zdravilo, ki ni pretečeno.
• 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.
FORSTEA ne priporočamo uporabljati slepim ali slabovidnim osebam, ki so brez pomoči ali osebe, usposobljene za pravilno uporabo medicinskega pripomočka.
Manufactured by Lilly France, F-67640 Fegersheim, France for Eli Lilly and Company.
Izdeluje Lilly France, F- 67640 Fegersheim, Francija za Eli Lilly and Company.
Fosavance is a medicine containing two active substances: alendronate sodium trihydrate and colecalciferol (vitamin D3).
Fosavance je zdravilo, ki vsebuje dve zdravilni učinkovini: natrijev alendronat trihidrat in holekalciferol (vitamin D3).
It is available as white tablets (capsule-shaped:
Na voljo je v obliki belih tablet (kapsuli podobne oblike:
70 mg alendronate sodium trihydrate and 2,800 international units [IU] colecalciferol; rectangular:
70 mg natrijevega alendronata trihidrata in 2800 mednarodnih enot [i. e.] holekalciferola; pravokotniku podobne oblike:
70 mg alendronate sodium trihydrate and 5,600 IU colecalciferol).
70 mg natrijevega alendronata trihidrata in 5600 i. e. holekalciferola).
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.
Zdravilo Fosavance (ki vsebuje bodisi 2800 ali 5600 i. e. holekalciferola) se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D.
Fosavance 70 mg/ 5,600 IU is for use in patients who are not taking vitamin D supplements.
Zdravilo Fosavance 70 mg/ 5600 i. e. se uporablja pri bolnikih, ki ne jemljejo dodatkov vitamina D.
Fosavance reduces the risk of vertebral (spine) and hip fractures (breaks).
Zdravilo Fosavance zmanjšuje tveganje za vertebralne zlome (zlome hrbtenice) in zlome kolka.
Fosavance is intended for long-term use.
Zdravilo Fosavance je namenjeno dolgotrajni uporabi.
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).
Bolnik mora tableto zaužiti s polnim kozarcem vode (ne mineralne vode), in sicer najmanj 30 minut pred zaužitjem hrane, pijače ali drugih zdravil (vključno z antacidi, dodatki kalcija in vitamini).
Patients should also take calcium supplements if they are not getting enough calcium from their diet.
Bolniki morajo jemati tudi nadomestni kalcij, če njegov vnos s prehrano ni zadosten.
Osteoporosis is a disease in which the bones gradually become thin and fragile, and more likely to break (fracture).
Osteoporoza je bolezen, zaradi katere kosti postopoma postanejo tanke in krhke ter posledično bolj lomljive.
Alendronate is a bisphosphonate that has been used in osteoporosis since the mid-1990s.
Osteoporoza je pogostejša pri ženskah po menopavzi, ko raven ženskega hormona estrogena pade, saj estrogen prispeva k ohranjanju zdravih kosti.
Reproduction is authorised provided the source is acknowledged. these cells, alendronate leads to less bone loss.
Zdravilni učinkovini zdravila Fosavance sta alendronat in holekalciferol (vitamin D3).
Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.
Glede na to da utegnejo bolniki z osteoporozo z izpostavljanjem sončni svetlobi dobiti premalo vitamina D3, je ta vključen v zdravilo 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.
Ker se alendronat in vitamin D3 ločeno že uporabljata v zdravilih, odobrenih v EU, je družba predložila podatke iz starejših študij ter iz objavljene literature.
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.
Družba je izvedla tudi študijo, v katero je bilo vključenih 35 moških in 682 žensk s pomenopavzalno osteoporozo, da bi tako dokazala učinkovitost zdravila Fosavance pri zviševanju ravni vitamina D.
Patients received either Fosavance 70 mg/ 2,800 IU or alendronate only once a week.
Bolniki so enkrat tedensko prejemali bodisi zdravilo Fosavance 70 mg/ 2800 i. e. bodisi le alendronat.
The main measure of effectiveness was the percentage of patients with low vitamin D levels after 15 weeks.
Glavno merilo učinkovitosti je bil delež bolnikov z nizko ravnjo vitamina D po 15 tednih zdravljenja.
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).
Ta študija je bila pri 652 bolnikih podaljšana za nadaljnjih 24 tednov z namenom primerjati učinke nadaljevanja zdravljenja samo z zdravilom Fosavance 70 mg/ 2800 i. e. z učinki dodajanja 2800 i. e. vitamina D3 (kar je enakovredno uporabi zdravila Fosavance 70 mg/ 5600 i. e.).
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%).
Po 15 tednih zdravljenja je bil delež bolnikov z nizko ravnjo vitamina D med bolniki, zdravljenimi z zdravilom Fosavance 70 mg/ 2800 i. e., nižji (11%) kot pri tistih, ki so prejemali le alendronat (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.
V podaljšani študiji so bolniki, ki so prejemali zdravilo Fosavance 70 mg/ 5600 i. e., imeli v 24 tednih študije večje povečanje ravni vitamina D, kljub temu, da je bilo število bolnikov z nizkimi ravnmi vitamina D v skupini bolnikov, ki so jemali zdravilo Fosavance 70 mg/ 2800 i. e., podobno številu v skupini bolnikov, ki so prejemali zdravilo Fosavance 70 mg/ 5600 i. e.
The company also presented evidence that the dose of alendronate included in Fosavance was the same as the dose needed to prevent bone loss.
Družba je predložila tudi dokazila, da je odmerek alendronata, ki ga vsebuje zdravilo Fosavance, enak odmerku, potrebnemu za preprečevanje izgube kostne mase.
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.
Najpogostejši neželeni učinki zdravila Fosavance (opaženi pri 1 do 10 izmed 100 bolnikov) so glavobol, mišično- skeletne bolečine (v kosteh, mišicah ali sklepih) in prebavne težave, kot so bolečine v trebuhu, dispepsija (slaba prebava), zaprtje, driska, flatulenca (vetrovi), razjede požiralnika, disfagija (težave pri požiranju), napet trebuh in refluks kisline.
For the full list of all side effects reported with Fosavance, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fosavance, glejte navodilo za uporabo.
Fosavance should not be used in people who may be hypersensitive (allergic) to alendronate, vitamin D3 or any of the other ingredients.
Zdravila Fosavance ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) alendronat, vitamin D3 ali katero koli drugo sestavino zdravila.
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.
Ne sme se uporabljati v primeru nenormalnosti požiralnika, pri bolnikih s hipokalciemijo (nizkimi ravnmi kalcija) ali pri bolnikih, ki ne morejo stati ali sedeti vzravnano vsaj 30 minut.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Fosavance pri zdravljenju pomenopavzalne osteoporoze pri bolnikih s tveganjem za pomanjkanje vitamina D večje od z njim povezanih tveganj.
The Committee recommended that Fosavance be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Fosavance odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the EU for Fosavance to Merck Sharp & Dohme Ltd. on 24 August 2005.
Evropska komisija je dovoljenje za promet z zdravilom Fosavance, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd. dne 24. avgusta 2005.
The full EPAR for Fosavance is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fosavance je na voljo tukaj.
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
70 mg/ 5. 600 i. e.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
tableta tableta tableta tableta tableta tableta tableta tableta tableta
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)
Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu) Pretisni omot (alu/ alu)
2 tablets 4 tablets 6 tablets 12 tablets 40 tablets 2 tablets 4 tablets 12 tablets 40 tablets
2 tableti 4 tablete 6 tablet 12 tablet 40 tablet 2 tableti 4 tablete 12 tablet 40 tablet
FOSAVANCE 70 mg/ 2800 IU tablets
FOSAVANCE 70 mg/ 2. 800 i. e. tablete
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate, and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Vsaka tableta vsebuje 70 mg alendronske kisline v obliki natrijevega alendronata trihidrata in 70 mikrogramov (2. 800 i. e.) holekalciferola (vitamina D3)
FOSAVANCE reduces the risk of vertebral and hip fractures.
FOSAVANCE zmanjša tveganje za vertebralne zlome in za zlome kolka.
The recommended dosage is one FOSAVANCE tablet once weekly.
Priporočeni odmerek je ena FOSAVANCE tableta enkrat tedensko.
Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use.
Zaradi narave bolezenskega procesa osteoporoze, je FOSAVANCE namenjen za dolgotrajno uporabo.
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.
Moramo FOSAVANCE vzeti izključno z navadno vodo (ne z mineralno vodo) najmanj pol ure pred prvim dnevnim obrokom hrane in pijače ali zaužitjem drugih zdravil (vključno z antacidi, pripravki kalcija in vitamini).
• FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200ml or 7fl. oz.).
• bolnik mora FOSAVANCE pogoltniti zjutraj, ko vstane, s polnim kozarcem vode (ne manj kot 200 ml),
• Patients should not lie down for at least 30 minutes after taking FOSAVANCE.
2 • bolnik se še vsaj 30 minut po zaužitju tablete FOSAVANCE ne sme uleči,
2 • FOSAVANCE should not be taken at bedtime or before arising for the day.
• bolnik zdravila FOSAVANCE ne sme vzeti pred spanjem ali preden zjutraj vstane.
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.
Ekvivalent vnosa 2. 800 i. e. vitamina D3 tedensko v zdravilu FOSAVANCE dnevnemu odmerjanju vitamina D 400 i. e. ni bil preučevan.
FOSAVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min, due to lack of experience.
Bolnikom, pri katerih je hitrost glomerulne filtracije pod 35 ml/ min, pa se zdravilo FOSAVANCE zaradi pomanjkanja izkušenj ne priporoča.
FOSAVANCE has not been studied in children and adolescents and therefore should not be given to them.
Zdravila FOSAVANCE pri otrocih in mladostnikih niso preučevali, zato ga ne smejo jemati.
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.
O osteonekrozi čeljusti, navadno povezani z ekstrakcijo zoba in / ali lokalno okužbo (vključno z osteomielitisom), so poročali pri bolnikih z rakom, ki so kot del zdravljenja prejemali predvsem intravensko aplicirane bisfosfonate.
FOSAVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min (see section 4.2).
Bolnikom, pri katerih je hitrost glomerulne filtracije manjša od 35 ml/ min, se zdravila FOSAVANCE ne priporoča (glejte poglavje 4. 2).
Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
Hipokalcemijo je treba korigirati pred začetkom zdravljenja z zdravilom FOSAVANCE (glejte poglavje 4. 3).
The content of vitamin D in FOSAVANCE is not suitable for correction of vitamin D deficiency.
Količina vitamina D v zdravilu FOSAVANCE ne zadošča za odpravo pomanjkanja vitamina D.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE.
Pri bolnikih s temi boleznimi je treba med zdravljenjem z zdravilom FOSAVANCE spremljati serumski kalcij in simptome hipokalcemije.
FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
FOSAVANCE je namenjen le ženskam po menopavi, zato se ga ne sme uporabljati v času nosečnosti ali dojenja.
There are no adequate data from the use of FOSAVANCE in pregnant women.
Ni zadostnih podatkov o uporabi zdravila FOSAVANCE pri nosečnicah.
However, there is no information to indicate that FOSAVANCE affects a patient’ s ability to drive or operate machines.
Vendar pa ni podatkov, ki bi kazali, da FOSAVANCE vpliva na sposobnost vožnje ali upravljanja s stroji.
No additional adverse reactions have been identified for FOSAVANCE.
Pri zdravilu FOSAVANCE niso ugotovili dodatnih neželenih učinkov.
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.
Pojavnost zmanjšanja serumskega kalcija na < 8, 0 mg/ dl (2, 0 mmol/ l) in serumskega fosfata na ≤ 2, 0 mg/ dl (0, 65 mmol/ l) pa je bila v obeh skupinah podobna.
6 4.9 Overdose
4. 9 Preveliko odmerjanje
Alendronate Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
Alendronat Zaradi prekomernih peroralnih odmerkov lahko pride do hipokalcemije, hipofosfatemije in neželenih učinkov v zgornjem delu prebavil, kot so razdraženost želodca, zgaga, ezofagitis, gastritis ali razjeda.
Colecalciferol Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/ day.
6 Holekalciferol Toksičnega učinka vitamina D pri sicer na splošno zdravih odraslih, ki so dlje časa dobivali odmerke manj kot 10. 000 i. e. dnevno, niso ugotovili.
FOSAVANCE is a combination tablet containing the two active substances alendronate sodium trihydrate and colecalciferol (vitamin D3).
FOSAVANCE je kombinirana tableta, ki vsebuje dve zdravilni učinkovini natrijev alendronat trihidrat in holekalciferol (vitamin D3).
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]).
Raziskave z zdravilom FOSAVANCE Vpliv zdravila FOSAVANCE (alendronat 70 mg/ vitamin D3 2. 800 i. e.) na status vitamina D so ugotavljali v 15- tedenski, mednarodni raziskavi, v katero je bilo vključenih 682 žensk s pomenopavzalno osteoporozo (serumski 25- hidroksivitamin D ob začetku raziskave: povprečna vrednost 56 nmol/ l [22, 3 ng/ ml]; obseg vrednosti 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
Bolnice so enkrat tedensko dobivale manjšo jakost (70 mg/ 2. 800 i. e.) zdravila FOSAVANCE (n = 350) ali zdravilo FOSAMAX (alendronat) 70 mg (n = 332) enkrat tedensko; dodatno jemanje vitamina D je bilo prepovedano.
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]).
Po 15 tednih zdravljenja so bile srednje serumske vrednosti 25- hidroksivitamina D v skupini, ki je dobivala FOSAVANCE (70 mg/ 2. 800 i. e.), pomembno večje (26%) (56 nmol/ l [23 ng/ ml]) kot v skupini, ki je jemala samo alendronat (46 nmol/ l [18, 2 ng/ ml]).
The percentage of patients with vitamin D insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/ l [< 15 ng/ ml]) was significantly reduced by 62.5% with FOSAVANCE (70 mg/ 2800 IU) vs. alendronate-only (12% vs.
Delež bolnic s pomanjkanjem vitamina D (serumski 25- hidroksivitamin D < 37, 5 nmol/ l [< 15 ng/ mol]) je bil v skupini, ki je prejemala FOSAVANCE (70 mg/ 2. 800 i. e.) pomembno nižji (za 62, 5%) kot v skupini, ki je prejemala le alendronat (12% oz.
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).
Delež bolnic s hudim pomanjkanjem vitamina D (serumski 25- hidroksivitamin D ≤ 22, 5 nmol/ l [≤ 9 ng/ mol]) je bil v skupini, ki je
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).
V tej raziskavi so se srednje vrednosti 25- hidroksivitamina D pri bolnicah s pomanjkanjem vitamina D (25- hidroksivitamin D, 22, 5 do 37, 5 nmol/ l [9 do < 15 ng/ ml]) dvignili z začetnih 30 nmol/ l (12, 1 ng/ ml) na 40 nmol/ l (15, 9 ng/ ml) v 15. tednu v skupini, ki je prejemala FOSAVANCE (70 mg/ 2. 800 i. e.) (n=75) in znižali z začetnih 30 nmol/ l (12, 0 ng/ ml) na 26 nmol/ l (10, 4 ng/ ml) v 15. tednu v skupini, ki je prejemala le alendronat (n=70).
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.
V raziskavah
In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
8 osteoporoze je bil alendronat učinkovit pri jemanju vsaj 30 minut pred prvim dnevnim obrokom hrane ali pijače.
The alendronate component in the FOSAVANCE (70 mg/ 2800 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Alendronat v kombinirani tableti FOSAVANCE (70 mg/ 2. 800 i. e.) je bioekvivalenten alendronatu v 70 mg tableti.
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.
Absorpcija Pri zdravih odraslih preiskovancih (moški in ženske) je po zaužitju zdravila FOSAVANCE na tešče (po postu celo noč) in dve uri pred obrokom povprečna površina pod krivuljo serumska koncentracija - čas (AUC0- 120 ur) za vitamin D3 (neprilagojen endogenim vrednostim vitamina D3) znašala 296, 4 ng h/ ml.
The bioavailability of the 2800 IU vitamin D3 in FOSAVANCE is similar to 2800 IU vitamin D3 administered alone.
Biološka uporabnost 2. 800 i. e. vitamina D3 v zdravilu FOSAVANCE je podobna kot pri zaužitju samo 2. 800 i. e. vitamina D3.
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%.
Izločanje Pri zdravih preiskovancih, ki so dobili radioaktivni vitamin D3, se je z urinom po 48 urah izločilo povprečno 2, 4% radioaktivnosti, povprečno izločanje radioaktivnosti z blatom po 4 dneh pa je bilo
The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/ 2800 IU) is approximately 24 hours.
Povprečni razpolovni čas vitamina D3 v serumu po peroralnem odmerku zdravila FOSAVANCE (70 mg/ 2. 800 i. e.) je približno 24 ur.
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 tableti EU/ 1/ 05/ 310/ 002 – 4 tablete EU/ 1/ 05/ 310/ 003 – 6 tablet EU/ 1/ 05/ 310/ 004 – 12 tablet EU/ 1/ 05/ 310/ 005 – 40 tablet
FOSAVANCE 70 mg/ 5600 IU tablets
FOSAVANCE 70 mg/ 5. 600 i. e. tablete
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3).
Vsaka tableta vsebuje 70 mg alendronske kisline v obliki natrijevega alendronata trihidrata in 140 mikrogramov (5. 600 i. e.) holekalciferola (vitamina D3)
The recommended dosage is one FOSAVANCE tablet once weekly.
Priporočeni odmerek je ena tableta FOSAVANCE enkrat tedensko.
12 • Patients should not lie down for at least 30 minutes after taking FOSAVANCE.
12 • bolnik se še vsaj 30 minut po zaužitju tablete FOSAVANCE ne sme uleči,
• FOSAVANCE should not be taken at bedtime or before arising for the day.
• bolnik zdravila FOSAVANCE ne sme vzeti pred spanjem ali preden zjutraj vstane.