natgillin/translations-raw huggingface dataset:
Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4)..
V kolikor je vnos s hrano nezadosten, morajo bolniki prejemati nadomestni kalcij (glejte poglavje 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.
Ekvivalent vnosa 5. 600 i. e. vitamina D3 tedensko v zdravilu FOSAVANCE dnevnemu odmerjanju vitamina D 800 i. e. ni bil preučevan.
15 Nervous system disorders:
Pogosti: glavobol Bolezni živčevja Redke: uveitis, skleritis, episkleritis Očesne bolezni
Osteonecrosis of the jaw has been reported in patients treated by
V kliničnih raziskavah so opazili asimptomatska, blaga in prehodna zmanjšanja serumskega kalcija in fosfata: pri bolnikih, ki so jemali alendronat 10 mg na dan, za približno 18% oz.
The majority of the reports refer to cancer patients, bone disorders:
3%.
Colecalciferol Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/ day.
16 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 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]).
Raziskave z zdravilom FOSAVANCE Vpliv nižjega odmerka 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
Bolnice so enkrat tedensko dobivale zmanjšano 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.
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 pomanjkanjem vitamina D (serumski 25- hidroksivitamin D ≤ 22, 5 nmol/ l [≤ 9 ng/ mol]) je bil v skupini, ki je prejemala
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).
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.
(vrednost vitamina D3 v višjem odmerku zdravila FOSAVANCE) enkrat tedensko, so ugotavljali v 24- tedenski podaljšani raziskavi, v katero je bilo vključenih 619 žensk s pomenopavzalno osteoporozo.
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.
Bolnice v skupini "Vitamin D3 2. 800" so prejemale FOSAVANCE (70 mg/ 2. 800 i. e.) (n=299), bolnice v skupini "Vitamin D3 5. 600" pa so prejemale FOSAVANCE (70 mg/ 2. 800 i. e.) in dodatnih 2. 800 i. e. vitamina D3 (n=309) enkrat tedensko; dovoljeni so bili tudi drugi dodatki vitamina D.
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]).
Po 24- ih tednih zdravljenja so bile srednje serumske vrednosti 25- hidroksivitamina D v skupini "Vitamin D3 5. 600" pomembno večje (69 nmol/ l [27, 6 ng/ ml]) kot v skupini "Vitamin D3 2. 800" (64 nmol/ l [25, 5 ng/ ml]).
A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture.
V tej raziskavi je dnevno zdravljenje z alendronatom zmanjšalo pojavnost enega ali več novih zlomov vretenc za 47% (alendronat 7, 9% v primerjavi s placebom 15, 0%).
In this study alendronate daily reduced the incidence of ≥ 1 new
Statistično značilno zmanjšanje je bilo ugotovljeno tudi pri pojavnosti zlomov kolka (1, 1% v primerjavi z 2, 2%, 51% zmanjšanje).
18 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
Štiriletna raziskava pri 4. 432 bolnicah z nizko kostno maso, vendar na začetku brez zloma • vretenca.
2.2%, a reduction of 51%).
V tej raziskavi so pri analizi podskupine žensk z osteoporozo (37% svetovne populacije, ki ustreza že omenjeni definiciji osteoporoze) opazili pomembno razliko v pojavnosti zlomov kolka (alendronat 1, 0% v primerjavi s placebom 2, 2%, 56% zmanjšanje) in v pojavnosti ≥ 1 zlomov vretenc (2, 9% v primerjavi s 5, 8%, 50% zmanjšanje).
A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture.
5. 2 Farmakokinetične lastnosti
The alendronate component in the FOSAVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Alendronat v kombinirani tableti FOSAVANCE (70 mg/ 5. 600 i. e.) je bioekvivalenten alendronatu v 70 mg tableti.
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.
Absorpcija Pri zdravih odraslih preiskovancih (moški in ženske) je po zaužitju zdravila FOSAVANCE 70 mg/ 5. 600 i. e. na tešče (po postu celo noč) 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.
The bioavailability of the 5600 IU vitamin D3 in FOSAVANCE is similar to 5600 IU vitamin D3 administered alone.
Biološka uporabnost 5. 600 i. e. vitamina D3 v zdravilu FOSAVANCE je podobna kot pri zaužitju samo 5. 600 i. e. vitamina D3.
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)
mikrokristalna celuloza (E460) brezvodna laktoza srednjeverižni trigliceridi želatina premrežen natrijev karmelozat saharoza koloidni silicijev dioksid magnezijev stearat (E572) butilhidroksitoluen (E321) modificiran škrob (koruzni) natrijev aluminijev silikat (E554) 6. 2 Inkompatibilnosti
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 tableti EU/ 1/ 05/ 310/ 007 – 4 tablete EU/ 1/ 05/ 310/ 008 – 12 tablet EU/ 1/ 05/ 310/ 009 – 40 tablet
24 August 2005
21 24. avgust 2005
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.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne dejavnosti, ki so opisane v Farmakovigilančnem načrtu, tako kot je bilo dogovorjeno v različici 1 Načrta tveganja predstavljenega v Modulu 1. 8. 2. vloge, ter naknadnih dopolnil Načrta tveganja potrjenih s strani Odbora za zdravila za uporabo v humani medicini (CHMP).
FOSAVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
FOSAVANCE 70 mg/ 2. 800 i. e. tablete Alendronska kislina v obliki natrijevega alendronata trihidrata/ holekalciferol
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 2800 IU
FOSAVANCE 70 mg 2. 800 i. e.
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).
Ko na izbrani dan zjutraj vstanete in še preden pojeste prvo hrano ali popijete prvo pijačo ali vzamete katero koli drugo zdravilo, pogoltnite (ne žvečite in ne raztapljajte v ustih) eno tableto FOSAVANCE s polnim kozarcem vode (ne z mineralno vodo).
Don’ t lie down, eat, drink or take other medicines for at least 30 minutes.
Ne uležite se, ne jejte, ne pijte in ne jemljite drugih zdravil vsaj še 30 minut.
Remember, take FOSAVANCE once each week on that same day for as long as your doctor prescribes it.
Zapomnite si - FOSAVANCE je treba vzeti le enkrat na teden, vedno na ta isti dan v tednu, tako dolgo, dokler vam ga je predpisal zdravnik.
There is important additional information about how to take FOSAVANCE in the enclosed package leaflet.
V priloženem navodilu za uporabo so pomembne dodatne informacije o jemanju zdravila FOSAVANCE.
For your convenience, place a sticker on your calendar each week as a reminder to take your FOSAVANCE.
Da se boste lažje spomnili, kdaj je treba vzeti FOSAVANCE, na koledar nalepite nalepko za vsak teden.
FOSAVANCE WEEK 1 FOSAVANCE WEEK 2 FOSAVANCE WEEK 3 FOSAVANCE WEEK 4 TIME TO REFILL
FOSAVANCE TEDEN 1 FOSAVANCE TEDEN 2 FOSAVANCE TEDEN 3 FOSAVANCE TEDEN 4 TREBA JE PO NOV RECEPT
FOSAVANCE 70 mg/ 5600 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
FOSAVANCE 70 mg/ 5. 600 i. e. tablete Alendronska kislina v obliki natrijevega alendronata trihidrata in holekalciferol
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 tableti) EU/ 1/ 05/ 310/ 007 (4 tablete) EU/ 1/ 05/ 310/ 008 (12 tablet) EU/ 1/ 05/ 310/ 009 (40 tablet)
FOSAVANCE 70 mg 5600 IU
FOSAVANCE 70 mg 5. 600 i. e.
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).
Ko na izbrani dan zjutraj vstanete in še preden pojeste prvo hrano ali popijete prvo pijačo ali vzamete katerokoli drugo zdravilo, pogoltnite (ne žvečite in ne raztapljajte v ustih) eno tableto FOSAVANCE s polnim kozarcem vode (ne z mineralno vodo).
34 Take one tablet once a week
Prosimo, da jih natančno preberete.
Mark the day of the week that best fits your schedule:
Vzemite eno tableto enkrat na teden 34 Označite dan v tednu, ki vam najbolj ustreza:
Date: _____ WEEK 3.
Datum: ____ TEDEN 3.
Date: _____ TIME TO REFILL
Datum: _____ TREBA JE PO NOV RECEPT
FOSAVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
FOSAVANCE 70 mg/ 2. 800 i. e. tablete alendronska kislina v obliki natrijevega alendronata trihidrata/ holekalciferol
FOSAVANCE, before taking this medicine.
ZDRAVILO FOSAVANCE.
2.
Kaj je zdravilo FOSAVANCE in za kaj ga uporabljamo 2.
3.
Kaj morate vedeti, preden boste vzeli zdravilo FOSAVANCE 3.
4.
Kako jemati zdravilo FOSAVANCE 4.
What FOSAVANCE is and what it is used for Before you take FOSAVANCE How to take FOSAVANCE Possible side effects How to store FOSAVANCE Further information
Dodatne informacije
WHAT FOSAVANCE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FOSAVANCE IN ZA KAJ GA UPORABLJAMO
What is FOSAVANCE?
Kaj je FOSAVANCE?
FOSAVANCE is a tablet containing the two active substances, alendronate sodium trihydrate and colecalciferol known as vitamin D3.
FOSAVANCE je tableta, ki vsebuje dve zdravilni učinkovini: natrijev alendronat trihidrat in holekalciferol oziroma vitamin D3.
Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
Zdravnik vam je predpisal FOSAVANCE za zdravljenje osteoporoze in zato, ker pri vas obstaja tveganje pomanjkanja vitamina D.
FOSAVANCE reduces the risk of spine and hip fractures.
FOSAVANCE zmanjša tveganje za zlome hrbtenice in za zlome kolka.
FOSAVANCE is a once weekly treatment.
FOSAVANCE se uporablja za enkrat tedensko zdravljenje.
FOSAVANCE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.
FOSAVANCE ne le preprečuje izgubo kostnine, ampak tudi pomaga pri ponovni gradnji kosti, ki ste jo že izgubili, ter zmanjša tveganje za zlome hrbtenice in kolka.
BEFORE YOU TAKE FOSAVANCE
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO FOSAVANCE
Do not take FOSAVANCE (1) if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients, (2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing, (3) if you cannot stand or sit upright for at least 30 minutes, (4) if your doctor has told you that you have low blood calcium.
(1) če ste alergični na (preobčutljivi za) natrijev alendronat trihidrat, holekalciferol ali katerokoli drugo sestavino, (2) če imate težave s požiralnikom (del prebavne cevi med žrelom in želodcem) kot je zoženo ali oteženo požiranje, (3) če ne morete stati ali pokončno sedeti vsaj 30 minut, (4) če vam je zdravnik povedal, da imate nizko vrednost kalcija v krvi.
Take special care with FOSAVANCE It is important to tell your doctor before taking FOSAVANCE • if you suffer from kidney problems, • if you have any allergies, • if you have any swallowing or digestive problems, • if you have low blood calcium levels, • if you have cancer, • if you are undergoing chemotherapy or radiotherapy, • if you are taking steroids, • if you don’ t receive routine dental care.
Bodite posebno pozorni pri jemanju zdravila FOSAVANCE Pomembno je, da pred začetkom jemanja zdravila FOSAVANCE poveste svojemu zdravniku: • če imate težave z ledvicami, • če imate kakšne alergije, • če imate kakšne težave pri požiranju ali s prebavo, • če imate nizke vrednosti kalcija v krvi, • če imate raka, • če prejemate kemoterapijo ali radioterapijo, • če jemljete steroide, • če nimate rednih zobzdravniških pregledov.
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 (del prebavne cevi med žrelom in želodcem), navadno z znaki bolečine v prsnem košu, zgage ali težkega/ bolečega požiranja, še posebej če bolnik 30 minut po zaužitju zdravila FOSAVANCE ne spije polnega kozarca vode in/ ali če se po zaužitju zdravila uleže.
These side effects may worsen if patients continue to take FOSAVANCE after developing these symptoms.
Neželeni učinki se lahko stopnjujejo, če bolnik nadaljuje z jemanjem zdravila FOSAVANCE potem, ko so se že pojavili neželeni učinki.
39 Children and adolescents FOSAVANCE should not be given to children and adolescents.
39 Otroci in mladostniki Zdravila FOSAVANCE se ne sme dajati otrokom ali mladostnikom.
Taking other medicines It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time.
Jemanje drugih zdravil Verjetno je, da bi lahko pripravki kalcija, antacidi in nekatera peroralna zdravila motili absorpcijo zdravila FOSAVANCE, če bi jih vzeli istočasno.
HOW TO TAKE FOSAVANCE.
KAKO JEMATI ZDRAVILO FOSAVANCE.
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, orlistat and the cholesterol- lowering medicines, cholestyramine and colestipol.
Verjetno je, da bi lahko določena zdravila ali dodatki hrani, vključno z umetnimi nadomestki maščob, mineralnimi olji, orlistatom in zdravili za zniževanje holesterola, holestiraminom in holestipolom, preprečevala vnos vitamina D in zdravila FOSAVANCE v telo.
Taking FOSAVANCE with food and drink It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time.
Jemanje zdravila FOSAVANCE skupaj s hrano in pijačo Verjetno je, da bi lahko hrana in pijače (vključno z mineralno vodo) zmanjšale učinek zdravila FOSAVANCE ob sočasnem zaužitju.
Pregnancy and breast-feeding FOSAVANCE is only intended for use in postmenopausal women.
Nosečnost in dojenje FOSAVANCE je namenjen le ženskam po menopavzi.
Driving and using machines FOSAVANCE should not affect your ability to drive or operate machines.
Vpliv na sposobnost upravljanja vozil in strojev FOSAVANCE ne bi smel vplivati na vašo sposobnost vožnje in upravljanja strojev.
Important information about some of the ingredients of FOSAVANCE FOSAVANCE contains lactose and sucrose.
Pomembne informacije o nekaterih sestavinah zdravila FOSAVANCE FOSAVANCE vsebuje laktozo in saharozo.
HOW TO TAKE FOSAVANCE
KAKO JEMATI ZDRAVILO FOSAVANCE
Follow these instructions carefully to make sure you will benefit from FOSAVANCE.
Da vam bo zdravilo FOSAVANCE pomagalo, morate upoštevati spodnja navodila.
Every week, take one FOSAVANCE tablet on your chosen day.
Izberite dan v tednu, ki vam najbolje ustreza, nato pa vsak teden na izbrani dan vzemite eno tableto FOSAVANCE.
It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).
Tako bo tableta FOSAVANCE lažje hitro prišla v želodec in možnost draženja požiralnika (del prebavne cevi med žrelom in želodcem) bo manjša.
2) After getting up for the day and before taking any food, drink, or other medicine, swallow your FOSAVANCE tablet with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.). • Do not take with mineral water (still or sparkling). • Do not take with coffee or tea. • Do not take with juice or milk.
Potem ko zjutraj vstanete in še preden zaužijete prvo hrano, pijačo ali katerokoli drugo zdravilo, pogoltnite tableto FOSAVANCE samo s polnim kozarcem vode (ne mineralne vode) (in ne manj kot 200 ml).
4) Do not take FOSAVANCE at bedtime or before getting up for the day.
Zdravila FOSAVANCE ne jemljite zvečer ali preden zjutraj vstanete.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
Če se pojavijo težave ali bolečine pri požiranju, bolečine v prsih, zgaga ali če se težave z zgago stopnjujejo, prenehajte jemati FOSAVANCE in se posvetujte z zdravnikom.
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.
Ko pogoltnete tableto FOSAVANCE, vsaj še 30 minut počakajte, preden zaužijete prvo hrano, pijačo ali katerokoli drugo zdravilo, vključno z antacidi, dodatki kalcija in vitamini.
FOSAVANCE is effective only if taken when your stomach is empty.
FOSAVANCE je učinkovit samo, če ga vzamete na tešče.
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 svojega zdravnika.
If you forget to take FOSAVANCE If you miss a dose, just take one tablet on the morning after you remember.
Če ste pozabili vzeti zdravilo FOSAVANCE Če pozabite vzeti odmerek, vzemite tableto FOSAVANCE naslednje jutro, potem ko se spomnite.
If you stop taking FOSAVANCE It is important that you continue taking FOSAVANCE for as long as your doctor prescribes the medicine.
Če ste prenehali jemati zdravilo FOSAVANCE Pomembno je, da FOSAVANCE jemljete tako dolgo, kot vam je predpisal zdravnik.
FOSAVANCE can treat your osteoporosis only if you continue to take the tablets.
FOSAVANCE lahko zdravi osteoporozo le, če ga redno jemljete.
Like all medicines, FOSAVANCE can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo FOSAVANCE neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Uncommon: • nausea; vomiting, • irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach, • black or tar-like stools, • rash; itching; redness of the skin.
Pogosti: • zgaga, težave pri požiranju, bolečine pri požiranju, razjede požiralnika, ki lahko povzročijo bolečine v prsnem košu, zgago ali težko/ boleče požiranje • bolečine v kosteh, mišicah in/ ali sklepih • bolečine v trebuhu, neprijeten občutek v želodcu ali napet trebuh po jedi, zaprtje, občutek polnega ali napihnjenega želodca, driska, vetroviž • glavobol
HOW TO STORE FOSAVANCE
SHRANJEVANJE ZDRAVILA FOSAVANCE
Do not use FOSAVANCE after the expiry date which is stated on the carton and the wallet after EXP.
Zdravila FOSAVANCE ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in zgibanki poleg oznake Uporabno do.
42 What FOSAVANCE looks like and contents of the pack
Izgled zdravila FOSAVANCE in vsebina pakiranja
FOSAVANCE 70 mg/ 2800 IU tablets are available as capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘ 710’ on the other.
FOSAVANCE 70 mg/ 2. 800 i. e. tablete so kapsuli podobne oblike, bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘ 710 ’.
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0)1 47 54 87 00 Contact@msd-france. com
Tel: +34 91 321 06 00 Fosavance@ msd. es France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 Contact@ msd- france. com
România Merck Sharp & Dohme Romania S. R. L.
Portugal Merck Sharp & Dohme, Lda Tel: +351 214 465 700 informacao_ doente@ merck. com România Merck Sharp & Dohme Romania S. R. L.
44 Lietuva UAB “ Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck. com
44 Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
45 PACKAGE LEAFLET:
45 NAVODILO ZA UPORABO
FOSAVANCE 70 mg/ 5600 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
FOSAVANCE 70 mg/ 5. 600 i. e. tablete alendronska kislina v obliki natrijevega alendronata trihidrata/ holekalciferol
46 Early on, osteoporosis usually has no symptoms.
46 Osteoporoza je v začetni fazi običajno brez simptomov.