natgillin/translations-raw huggingface dataset:
Contact your doctor promptly for advice if you notice any of these.
Če opazite kaj od tega, se nemudoma posvetujte z zdravnikom.
NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets hydrocortisone
Plenadren 5 mg tablete s prirejenim sproščanjem hidrokortizon peroralna uporaba
Tabulated list of adverse reactions
Posebne populacije Okvarjeno delovanje ledvic
NAME OF THE MEDICINAL PRODUCT Plenadren 5 mg modified-release tablets Plenadren 20 mg modified-release tablets
Plenadren 5 mg tablete s prirejenim sproščanjem Plenadren 20 mg tablete s prirejenim sproščanjem
PHARMACEUTICAL FORM AND CONTENTS Modified-release tablet
FARMACEVTSKA OBLIKA IN VSEBINA
STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains hydrocortisone 20 mg.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s prirejenim sproščanjem vsebuje 20 mg hidrokortizona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains hydrocortisone 5 mg.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta s prirejenim sproščanjem vsebuje 5 mg hidrokortizona.
Ask your doctor promptly for information on how you should handle these situations.
Glede ravnanja v takšnih primerih se nemudoma posvetujte z zdravnikom.
Tablet core
Tablete pogoltnite cele.
Package leaflet: Information for the patient
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Plenadren
You should tell your doctor if you become pregnant as the dose of Plenadren may have to be adjusted.
Če med jemanjem zdravila Plenadren zanosite, o tem obvestite zdravnika, saj bo morda moral prilagoditi odmerek.
Date of first authorisation: 24 August 2005 Date of latest renewal: 24 April 2015
Datum prve odobritve: 24. avgust 2005 Datum zadnjega podaljšanja: 24. april 2015
No special requirements.
Ni posebnih zahtev za.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo.
It contains important information reminding you how to take FOSAVANCE properly.
Ta vsebuje pomembne informacije, ki vas spomnijo, kako pravilno jemati zdravilo FOSAVANCE.
Due to the nature of the disease process in osteoporosis, FOSAVANCE is intended for long-term use.
Zaradi narave bolezenskega procesa osteoporoze je zdravilo FOSAVANCE namenjeno za dolgotrajno uporabo.
Children and adolescents FOSAVANCE should not be given to children and adolescents less than 18 years of age.
Otroci in mladostniki Zdravila FOSAVANCE se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let.
5,600 IU
5600 i.e.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
Therefore, caution should be used when these medicines are taken at the same time as FOSAVANCE.
Zato je potrebna previdnost, kadar ta zdravila uporabljate istočasno kot zdravilo FOSAVANCE.
FOSAVANCE has no or negligible direct influence on the ability to drive and use machines.
Zdravilo FOSAVANCE nima neposrednega vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• rash made worse by sunlight;
• izpuščaj, ki se poslabša na soncu
2,800 IU
2800 i.e.
Since it is not known how long you should take FOSAVANCE, you should discuss the need to stay on this medicine with your doctor periodically to determine if FOSAVANCE is still right for you.
Ker ni znano, kako dolgo je treba jemati zdravilo FOSAVANCE, se morate glede nadaljevanja zdravljenja s tem zdravilom redno posvetovati z zdravnikom, ki bo odločil, ali je zdravljenje z zdravilom FOSAVANCE za vas še vedno primerno.
If you take more FOSAVANCE than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Če ste vzeli večji odmerek zdravila FOSAVANCE, kot bi smeli Če po pomoti vzamete preveč tablet, popijte poln kozarec mleka in nemudoma pokličite zdravnika.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAVANCE on an individual patient basis, particularly after 5 or more years of use.
Potrebo po nadaljevanju zdravljenja z zdravilom FOSAVANCE je treba ponovno periodično oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
The safety and efficacy of FOSAVANCE in children less than 18 years of age have not been established.
Varnost in učinkovitost zdravila FOSAVANCE pri otrocih, mlajših od 18 let, nista bili dokazani.
Hypocalcaemia must be corrected before initiating therapy with FOSAVANCE (see section 4.3).
Hipokalciemijo je treba korigirati pred začetkom zdravljenja z zdravilom FOSAVANCE (glejte poglavje 4.3).
• Patients should not lie down for at least 30 minutes after taking FOSAVANCE and until after the first food of the day.
• Bolnik se ne sme uleči še vsaj 30 minut po zaužitju tablete FOSAVANCE in dokler ne zaužije prvega dnevnega obroka hrane.
As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:
Poleg zdravljenja z zdravilom FOSAVANCE vam zdravnik lahko svetuje nekaj sprememb v načinu življenja, ki pomagajo pri vaši bolezni.
It is important to maintain good oral hygiene when being treated with FOSAVANCE.
Pomembno je, da med zdravljenjem z zdravilom FOSAVANCE vzdržujete dobro ustno higieno.
FOSAVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
Zdravilo FOSAVANCE je namenjeno le ženskam po menopavzi, zato se ga ne sme uporabljati v času nosečnosti ali dojenja.
Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss.
Kljub temu da so zlomi običajno boleči, pa se zgodi, da se zlomov hrbtenice ne opazi, vse dokler ne povzročijo zmanjšanja telesne višine.
What FOSAVANCE is and what it is used for
Kaj je zdravilo FOSAVANCE in za kaj ga uporabljamo
• FOSAVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200 ml).
• Bolnik mora zdravilo FOSAVANCE pogoltniti zjutraj, ko vstane, s polnim kozarcem vode (ne manj kot 200 ml).
• you have been told you have trouble absorbing minerals in your stomach or intestines
• če so vam povedali, da imate težave z absorpcijo mineralov v želodcu ali črevesju (sindrom malabsorpcije),
Remember, take FOSAVANCE once each week on that same day for as long as your doctor prescribes it.
Zapomnite si - zdravilo FOSAVANCE je treba vzeti le enkrat na teden, vedno na isti dan v tednu, tako dolgo, kot vam ga je predpisal zdravnik.
Take one FOSAVANCE tablet once a week.
Vzemite eno tableto FOSAVANCE enkrat na teden.
FOSAVANCE should not be used during pregnancy.
Zdravila FOSAVANCE se med nosečnostjo ne sme uporabljati.
• unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
• redko se lahko pojavijo neobičajni zlomi stegnenice, zlasti pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
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 crush or chew the tablet or allow it to dissolve in your mouth) one FOSAVANCE tablet with a full glass of water (not mineral water).
Ko na izbrani dan zjutraj vstanete in še preden pojeste prvo hrano ali popijete prvo pijačo ali vzamete katero koli drugo zdravilo, pogoltnite (ne zdrobite, ne žvečite in ne raztapljajte v ustih) eno tableto FOSAVANCE s polnim kozarcem vode (ne z mineralno vodo).
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions,
• alergijske reakcije, kot so koprivnica, otekanje obraza, ustnic, jezika in/ali žrela, ki lahko otežuje dihanje ali požiranje, hude kožne reakcije
4) Do not take FOSAVANCE at bedtime or before getting up for the day.
4) Zdravila FOSAVANCE ne jemljite zvečer ali preden zjutraj vstanete.
An Instruction Card is included in the carton for FOSAVANCE.
V škatli zdravila FOSAVANCE je priložena kartica z navodili.
• Patients should only swallow FOSAVANCE whole.
• Bolnik mora pogoltniti celo tableto FOSAVANCE.
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.
Zdravilo FOSAVANCE je treba vzeti izključno z navadno vodo (ne z mineralno vodo) najmanj 30 minut pred prvim dnevnim obrokom hrane in pijače ali zaužitjem drugih zdravil (vključno z antacidi, pripravki kalcija in vitamini).
Certain medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause digestive problems.
Določena zdravila za zdravljenje revmatičnih obolenj ali dolgotrajne bolečine, imenovana nesteroidni antirevmatiki (NSAID) (npr.: acetilsalicilna kislina ali ibuprofen), lahko povzročijo prebavne motnje.
What FOSAVANCE is and what it is used for What you need to know before you take FOSAVANCE How to take FOSAVANCE
Kaj je zdravilo FOSAVANCE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo FOSAVANCE Kako jemati zdravilo FOSAVANCE Možni neželeni učinki
Patients should be instructed that if they miss a dose of FOSAVANCE they should take one tablet on the morning after they remember.
Bolnikom je treba naročiti, naj v primeru, da pozabijo vzeti odmerek zdravila FOSAVANCE, vzamejo eno tableto zjutraj potem, ko se spomnijo.
6) After swallowing your FOSAVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins.
6) Ko pogoltnete tableto FOSAVANCE, vsaj še 30 minut počakajte, preden zaužijete prvo hrano, pijačo ali katero koli drugo zdravilo, vključno z antacidi, dodatki kalcija in vitamini.
Other medicines and FOSAVANCE
Druga zdravila in zdravilo FOSAVANCE
What you need to know before you take FOSAVANCE
Kaj morate vedeti, preden boste vzeli zdravilo FOSAVANCE
Studies in animals have shown reproductive toxicity.
Študije na živalih so pokazale škodljiv vpliv na sposobnost razmnoževanja.
5 How to store FOSAVANCE Contents of the pack and other information
Shranjevanje zdravila FOSAVANCE Vsebina pakiranja in dodatne informacije
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
5) Če se pojavijo težave ali bolečine pri požiranju, bolečine v prsih, zgaga ali če se težave z zgago stopnjujejo, prenehajte jemati zdravilo FOSAVANCE in se posvetujte z zdravnikom.
It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time.
Dodatki kalcija, antacidi in nekatera zdravila, ki jih zaužijete, lahko motijo absorpcijo zdravila FOSAVANCE, če jih vzamete istočasno.
This leaflet was last revised in <{MM/YYYY}>
Navodilo je bilo nazadnje revidirano dne
If you miss a dose, take only one FOSAVANCE tablet on the morning after you remember.
Če pozabite vzeti odmerek, vzemite le eno tableto FOSAVANCE naslednje jutro, potem ko se spomnite.
Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3).
Študije na živalih so pri velikih odmerkih vitamina D pokazale hiperkalciemijo in škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
Irritation, inflammation or ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAVANCE.
Po zaužitju lahko pride do draženja, vnetja ali razjede požiralnika, pogosto z bolečino v prsnem košu, zgago ali oteženim ali bolečim požiranjem, še posebej, če bolnik ne spije polnega kozarca vode in/ali če se uleže prej kot v 30 minutah po zaužitju zdravila FOSAVANCE.
FOSAVANCE is only intended for use in postmenopausal women.
Zdravilo FOSAVANCE je namenjeno le ženskam po menopavzi.
The mean half-life of vitamin D3 in the serum following an oral dose of FOSAVANCE (70 mg/2,800 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.
FOSAVANCE is effective only if taken when your stomach is empty.
Zdravilo FOSAVANCE je učinkovito samo, če ga vzamete na tešče.
The other ingredients are microcrystalline cellulose (E460), lactose anhydrous (see section 2), medium chain triglycerides, gelatin, croscarmellose sodium, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E572), butylhydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).
Pomožne snovi so: mikrokristalna celuloza (E460), brezvodna laktoza (glejte poglavje 2), srednjeverižni trigliceridi, želatina, premreženi natrijev karmelozat, saharoza (glejte poglavje 2), koloidni silicijev dioksid, magnezijev stearat (E572), butilhidroksitoluen (E321), modificirani škrob (koruzni) in aluminijev natrijev silikat (E554).
FOSAVANCE is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
FOSAVANCE je tableta, ki vsebuje dve učinkovini: alendronsko kislino (splošno poimenovano alendronat) in holekalciferol oziroma vitamin D3.
If you forget to take FOSAVANCE
Če ste pozabili vzeti zdravilo FOSAVANCE
How to take FOSAVANCE tablets
Kako jemati tablete FOSAVANCE
FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Bolnikom z okvaro ledvic, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila FOSAVANCE zaradi pomanjkanja izkušenj ne priporočamo.
FOSAVANCE should not be used during breast-feeding.
Zdravila FOSAVANCE se med dojenjem ne sme uporabljati.
What FOSAVANCE looks like and contents of the pack
Izgled zdravila FOSAVANCE in vsebina pakiranja
You may be advised to have a dental check-up before starting treatment with FOSAVANCE.
Zdravnik vam bo lahko pred začetkom zdravljenja z zdravilom FOSAVANCE svetoval zobozdravniški pregled.
3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
3) Potem ko ste pogoltnili tableto, se ne ulezite, ampak še vsaj 30 minut ostanite v pokončnem položaju (sede, stoje ali hodeč).
FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Bolnikom, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila FOSAVANCE ne priporočamo (glejte poglavje 4.2).
In case of overdose with FOSAVANCE, milk or antacids should be given to bind alendronate.
Če bolnik vzame prekomeren odmerek zdravila FOSAVANCE, naj pije mleko ali vzame antacid, ki vežeta alendronat.
Patients received the lower strength (70 mg/2,800 IU) of FOSAVANCE (n=350) or FOSAMAX (alendronate) 70 mg (n=332) once a week; additional vitamin D supplements were prohibited.
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); jemanje dodatkov vitamina D je bilo prepovedano.
The bioavailability of the 5,600 IU vitamin D3 in FOSAVANCE is similar to 5,600 IU vitamin D3 administered alone.
Biološka uporabnost 5.600 i.e. vitamina D3 v zdravilu FOSAVANCE je podobna kot pri zaužitju 5.600 i.e. vitamina D3 samega.
Talk to your doctor or pharmacist before taking FOSAVANCE if:
Pred začetkom jemanja zdravila FOSAVANCE se posvetujte z zdravnikom ali farmacevtom:
What is FOSAVANCE used for?
Za kaj uporabljamo zdravilo FOSAVANCE?
The bioavailability of the 2,800 IU vitamin D3 in FOSAVANCE is similar to 2,800 IU vitamin D3 administered alone.
Biološka uporabnost 2.800 i.e. vitamina D3 v zdravilu FOSAVANCE je podobna kot pri zaužitju 2.800 i.e. vitamina D3 samega.
The effect of the lower dose of FOSAVANCE (alendronate 70 mg/vitamin D3 2,800 IU) plus an additional 2,800 IU Vitamin D3 for a total of 5,600 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.
Vpliv manjšega odmerka zdravila FOSAVANCE (alendronat 70 mg/vitamin D3 2.800 i.e.) in dodatnih 2.800 i.e. vitamina D3, kar pomeni skupaj 5.600 i.e. (količina vitamina D3 v večjem odmerku zdravila FOSAVANCE), enkrat tedensko, so ugotavljali v 24-tedenski podaljšani študiji, v katero je bilo vključenih 619 žensk s pomenopavzalno osteoporozo.
In this study, mean 25-hydroxyvitamin D levels in patients with vitamin D insufficiency at baseline (25-hydroxyvitamin D, 22.5 to 37.5 nmol/l [9 to < 15 ng/ml]) increased from 30 nmol/l (12.1 ng/ml) to 40 nmol/l (15.9 ng/ml) at week 15 in the FOSAVANCE (70 mg/2,800 IU) group (n=75) and decreased from 30 nmol/l (12.0 ng/ml) at baseline to 26 nmol/l (10.4 ng/ml) at week 15 in the alendronate-only group (n=70).
V tej študiji so se povprečne vrednosti 25-hidroksivitamina D pri bolnicah s pomanjkanjem vitamina D na začetku študije (25-hidroksivitamin D, 22,5 do 37,5 nmol/l [9 do <15 ng/ml]) v skupini, ki je prejemala zdravilo FOSAVANCE (70 mg/2.800 i.e.) (n = 75), v 15. tednu zvišale s 30 nmol/l (12,1 ng/ml) na 40 nmol/l (15,9 ng/ml), v skupini, ki je prejemala le alendronat (n = 70) pa v 15. tednu znižale s 30 nmol/l (12,0 ng/ml) na 26 nmol/l (10,4 ng/ml).
The effect of the lower dose of FOSAVANCE (alendronate 70 mg/vitamin D3 2,800 IU) on vitamin D status was demonstrated in a 15-week, multinational study that enrolled 682 osteoporotic post-menopausal women (serum 25-hydroxyvitamin D at baseline: mean, 56 nmol/l [22.3 ng/ml]; range, 22.5-225 nmol/l [9-90 ng/ml]).
Vpliv manjšega odmerka zdravila FOSAVANCE (alendronat 70 mg/vitamin D3 2.800 i.e.) na status vitamina D so ugotavljali v 15-tedenski, mednarodni študiji, v katero je bilo vključenih 682 žensk s pomenopavzalno osteoporozo (serumski 25-hidroksivitamin D ob začetku študije: povprečna vrednost 56 nmol/l [22,3 ng/ml]; obseg vrednosti 22,5-225 nmol/l [9-90 ng/ml]).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Zdravilo FOSAVANCE vsebuje laktozo in saharozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila pogovorite z zdravnikom.
FOSAVANCE studies
Študije z zdravilom FOSAVANCE
• 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.
It is important that you take FOSAVANCE for as long as your doctor prescribes the medicine.
Če ste prenehali jemati zdravilo FOSAVANCE Pomembno je, da zdravilo FOSAVANCE jemljete tako dolgo, kot vam je predpisal zdravnik.
It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
Določena zdravila ali dodatki hrani, vključno z umetnimi nadomestki maščob, mineralnimi olji, zdravili za hujšanje, orlistatom in zdravili za zniževanje holesterola, holestiraminom in holestipolom, lahko preprečijo absorpcijo vitamina D iz zdravila FOSAVANCE v telo.
There have been side effects (for example, blurred vision, dizziness and severe bone, muscle or joint pain) reported with FOSAVANCE that may affect your ability to drive or operate machinery (see section 4).
Vpliv na sposobnost upravljanja vozil in strojev Pri uporabi zdravila FOSAVANCE so poročali o neželenih učinkih (na primer zamegljenem vidu, omotici in hudih bolečinah v kosteh, mišicah ali sklepih), ki lahko vplivajo na vašo sposobnost vožnje ali upravljanja strojev (glejte poglavje 4).
Do not take FOSAVANCE
Ne jemljite zdravila FOSAVANCE
It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time.
Zdravilo FOSAVANCE skupaj s hrano in pijačo Hrana in pijače (vključno z mineralno vodo) lahko ob sočasnem zaužitju zmanjšajo učinek zdravila FOSAVANCE.
Colloidal silicon dioxide Magnesium stearate (E572) Butylhydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
6.1 Seznam pomožnih snovi mikrokristalna celuloza (E460) brezvodna laktoza srednjeverižni trigliceridi želatina premreženi natrijev karmelozat saharoza koloidni silicijev dioksid magnezijev stearat (E572) butilhidroksitoluen (E321) modificiran škrob (koruzni) aluminijev natrijev silikat (E554)
In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
Pri zdravih odraslih preiskovancih (moških in ženskah) je po zaužitju FOSAVANCE 70 mg/5.600 i.e. tablet zjutraj na tešče in dve uri pred obrokom povprečna površina pod krivuljo serumska koncentracija-čas (AUC0-80 ur) za vitamin D3 (neprilagojen endogenim vrednostim vitamina D3) znašala 490,2 ngh/ml.
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/1/05/310/001 (2 tableti) EU/1/05/310/002 (4 tablete) EU/1/05/310/003 (6 tablet) EU/1/05/310/004 (12 tablet)
The alendronate component in the FOSAVANCE (70 mg/2,800 IU) combination tablet and the FOSAVANCE (70 mg/5,600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Alendronat v kombinirani tableti FOSAVANCE (70 mg/2.800 i.e.) in kombinirani tableti FOSAVANCE (70 mg/5.600 i.e.) je bioekvivalenten alendronatu v 70 mg tableti.
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the FOSAVANCE (70 mg/2,800 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 povprečne vrednosti 25-hidroksivitamina D v serumu v skupini, ki je dobivala zdravilo FOSAVANCE (70 mg/2.800 i.e.), pomembno višje (26 %) (56 nmol/l [23 ng/ml]) kot v skupini, ki je jemala samo alendronat (46 nmol/l [18,2 ng/ml]).
The equivalence of intake of 2,800 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 400 IU has not been studied.
Ekvivalentnost vnosa 2.800 i.e. vitamina D3 tedensko z zdravilom FOSAVANCE in 400 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
In healthy adult subjects (males and females), following administration of FOSAVANCE 70 mg/2,800 IU tablets 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.
Pri zdravih odraslih preiskovancih (moških in ženskah) je po zaužitju FOSAVANCE 70 mg/2.800 i.e. tablet zjutraj na tešče 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 equivalence of intake of 5,600 IU of vitamin D3 weekly in FOSAVANCE to daily dosing of vitamin D 800 IU has not been studied.
Ekvivalentnost vnosa 5.600 i.e. vitamina D3 tedensko z zdravilom FOSAVANCE in 800 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Zdravilo FOSAVANCE je indicirano za zdravljenje pomenopavzalne osteoporoze pri ženskah s tveganjem za pomanjkanje vitamina D. Zdravilo zmanjša tveganje za vertebralne zlome in za zlome kolka.
EU/1/05/310/006 (2 tablets) EU/1/05/310/007 (4 tablets) EU/1/05/310/008 (12 tablets)
EU/1/05/310/006 (2 tableti) EU/1/05/310/007 (4 tablete) EU/1/05/310/008 (12 tablet)
FOSAVANCE 70 mg/2,800 IU tablets
FOSAVANCE 70 mg/2.800 i.e. tablete