FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: 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).
English: 2031 BN, Haarlem The Netherlands
Slovenian: 2031 BN, Haarlem Nizozemska
English: FOSAVANCE is a tablet containing the two active substances, alendronic acid (commonly called alendronate) and colecalciferol known as vitamin D3.
Slovenian: FOSAVANCE je tableta, ki vsebuje dve učinkovini: alendronsko kislino (splošno poimenovano alendronat) in holekalciferol oziroma vitamin D3.
English: If you forget to take FOSAVANCE
Slovenian: Če ste pozabili vzeti zdravilo FOSAVANCE
English: How to take FOSAVANCE tablets
Slovenian: Kako jemati tablete FOSAVANCE
English: FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
Slovenian: Bolnikom z okvaro ledvic, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila FOSAVANCE zaradi pomanjkanja izkušenj ne priporočamo.
English: FOSAVANCE should not be used during breast-feeding.
Slovenian: Zdravila FOSAVANCE se med dojenjem ne sme uporabljati.
English: What FOSAVANCE looks like and contents of the pack
Slovenian: Izgled zdravila FOSAVANCE in vsebina pakiranja
English: You may be advised to have a dental check-up before starting treatment with FOSAVANCE.
Slovenian: Zdravnik vam bo lahko pred začetkom zdravljenja z zdravilom FOSAVANCE svetoval zobozdravniški pregled.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Slovenian: 3) Potem ko ste pogoltnili tableto, se ne ulezite, ampak še vsaj 30 minut ostanite v pokončnem položaju (sede, stoje ali hodeč).
English: FOSAVANCE is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min (see section 4.2).
Slovenian: Bolnikom, pri katerih je kreatininski očistek manjši od 35 ml/min, zdravila FOSAVANCE ne priporočamo (glejte poglavje 4.2).
English: In case of overdose with FOSAVANCE, milk or antacids should be given to bind alendronate.
Slovenian: Če bolnik vzame prekomeren odmerek zdravila FOSAVANCE, naj pije mleko ali vzame antacid, ki vežeta alendronat.
English: 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.
Slovenian: 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.
English: The bioavailability of the 5,600 IU vitamin D3 in FOSAVANCE is similar to 5,600 IU vitamin D3 administered alone.
Slovenian: Biološka uporabnost 5.600 i.e. vitamina D3 v zdravilu FOSAVANCE je podobna kot pri zaužitju 5.600 i.e. vitamina D3 samega.
English: Talk to your doctor or pharmacist before taking FOSAVANCE if:
Slovenian: Pred začetkom jemanja zdravila FOSAVANCE se posvetujte z zdravnikom ali farmacevtom:
English: What is FOSAVANCE used for?
Slovenian: Za kaj uporabljamo zdravilo FOSAVANCE?
English: The bioavailability of the 2,800 IU vitamin D3 in FOSAVANCE is similar to 2,800 IU vitamin D3 administered alone.
Slovenian: Biološka uporabnost 2.800 i.e. vitamina D3 v zdravilu FOSAVANCE je podobna kot pri zaužitju 2.800 i.e. vitamina D3 samega.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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]).
Slovenian: 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]).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Zdravilo FOSAVANCE vsebuje laktozo in saharozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila pogovorite z zdravnikom.
English: FOSAVANCE studies
Slovenian: Študije z zdravilom FOSAVANCE
English: • FOSAVANCE should not be taken at bedtime or before arising for the day.
Slovenian: • Bolnik zdravila FOSAVANCE ne sme vzeti pred spanjem ali preden zjutraj vstane.
English: It is important that you take FOSAVANCE for as long as your doctor prescribes the medicine.
Slovenian: Če ste prenehali jemati zdravilo FOSAVANCE Pomembno je, da zdravilo FOSAVANCE jemljete tako dolgo, kot vam je predpisal zdravnik.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Do not take FOSAVANCE
Slovenian: Ne jemljite zdravila FOSAVANCE
English: It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time.
Slovenian: Zdravilo FOSAVANCE skupaj s hrano in pijačo Hrana in pijače (vključno z mineralno vodo) lahko ob sočasnem zaužitju zmanjšajo učinek zdravila FOSAVANCE.
English: Colloidal silicon dioxide Magnesium stearate (E572) Butylhydroxytoluene (E321) Modified starch (maize) Sodium aluminium silicate (E554)
Slovenian: 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)
English: 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.
Slovenian: 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.
English: 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)
Slovenian: 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)
English: 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.
Slovenian: 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.
English: 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]).
Slovenian: 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]).
English: 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.
Slovenian: Ekvivalentnost vnosa 2.800 i.e. vitamina D3 tedensko z zdravilom FOSAVANCE in 400 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ekvivalentnost vnosa 5.600 i.e. vitamina D3 tedensko z zdravilom FOSAVANCE in 800 i.e. vitamina D pri dnevnemu odmerjanju ni bila preučevana.
English: FOSAVANCE is indicated for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Slovenian: 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.
English: EU/1/05/310/006 (2 tablets) EU/1/05/310/007 (4 tablets) EU/1/05/310/008 (12 tablets)
Slovenian: EU/1/05/310/006 (2 tableti) EU/1/05/310/007 (4 tablete) EU/1/05/310/008 (12 tablet)
English: FOSAVANCE 70 mg/2,800 IU tablets
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete
English: • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing.
Slovenian: • zgaga, težave pri požiranju, bolečine pri požiranju, razjede požiralnika, ki lahko povzročijo bolečine v prsnem košu, zgago ali težko/boleče požiranje
English: Always take FOSAVANCE exactly as your doctor or pharmacist has told you.
Slovenian: Pri jemanju zdravila FOSAVANCE natančno upoštevajte navodila zdravnika ali farmacevta.
English: Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency.
Slovenian: Zdravnik vam je predpisal zdravilo FOSAVANCE za zdravljenje osteoporoze in zato, ker pri vas obstaja tveganje za pomanjkanje vitamina D. Zdravilo zmanjša tveganje za zlome hrbtenice in za zlome kolka pri ženskah po menopavzi.
English: What is FOSAVANCE?
Slovenian: Kaj je zdravilo FOSAVANCE?
English: FOSAVANCE 70 mg/5,600 IU tablets
Slovenian: FOSAVANCE 70 mg/5.600 i.e. tablete
English: FOSAVANCE 70 mg/2,800 IU tablets EU/1/05/310/001 - 2 tablets
Slovenian: FOSAVANCE 70 mg/5.600 i.e. tablete EU/1/05/310/006 - 2 tableti
English: 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/2,800 IU) vs. alendronate-only (1 % vs 13 %, respectively).
Slovenian: Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 22,5 nmol/l [< 9 ng/ml]) je bil v skupini, ki je prejemala zdravilo FOSAVANCE (70 mg/2.800 i.e.), pomembno nižji (za 92 %) kot v skupini, ki je prejemala le alendronat (1 % oz. 13 %).
English: FOSAVANCE 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
Slovenian: FOSAVANCE 70 mg/5.600 i.e tablete so na voljo v pakiranjih, ki vsebujejo 2, 4 ali 12 tablet.
English: FOSAVANCE 70 mg/2,800 IU tablets FOSAVANCE 70 mg/5,600 IU tablets
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete FOSAVANCE 70 mg/5.600 i.e. tablete
English: FOSAVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete so na voljo v pakiranjih, ki vsebujejo 2, 4, 6 ali 12 tablet.
English: FOSAVANCE 70 mg/5,600 IU tablets EU/1/05/310/006 - 2 tablets EU/1/05/310/007 - 4 tablets EU/1/05/310/008 - 12 tablets
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete 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
English: 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/2,800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Slovenian: Delež bolnic s pomanjkanjem vitamina D (serumski 25-hidroksivitamin D < 37,5 nmol/l [< 15 ng/ml]) je bil v skupini, ki je prejemala zdravilo FOSAVANCE (70 mg/2.800 i.e.), v 15. tednu pomembno nižji (za 62,5 %) kot v skupini, ki je prejemala le alendronat (12 % oz. 32 %).
English: FOSAVANCE 70 mg/2,800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete imajo obliko modificirane kapsule, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘710'.
English: Patients in the Vitamin D3 2,800 group received FOSAVANCE (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received FOSAVANCE (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Slovenian: Bolnice v skupini "Vitamin D3 2.800" so prejemale zdravilo FOSAVANCE (70 mg/2.800 i.e.) (n = 299), bolnice v skupini "Vitamin D3 5.600" pa so prejemale zdravilo 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. Po 24 tednih zdravljenja so bile povprečne vrednosti 25-hidroksivitamina D v serumu v skupini "Vitamin D3 5.600" pomembno višje (69 nmol/l [27,6 ng/ml]) kot v skupini "Vitamin D3 2.800" (64 nmol/l [25,5 ng/ml]).
English: FOSAVANCE 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
Slovenian: FOSAVANCE 70 mg/5.600 i.e. tablete imajo obliko modificiranega pravokotnika, so bele do skoraj bele barve, na eni strani imajo vtisnjen obris kosti, na drugi pa oznako ‘270'.
English: FOSAVANCE 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4, 6 ali 12 tablet.
English: FOSAVANCE 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Slovenian: FOSAVANCE 70 mg/5.600 i.e. tablete Pretisni omoti (aluminij/aluminij) v škatlah, ki vsebujejo 2, 4 ali 12 tablet.
English: What FOSAVANCE contains
Slovenian: Kaj vsebuje zdravilo FOSAVANCE
English: Each FOSAVANCE 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Slovenian: Ena FOSAVANCE 70 mg/2.800 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 70 mikrogramov (2.800 i.e.) holekalciferola (vitamina D3).
English: Each FOSAVANCE 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Slovenian: Ena FOSAVANCE 70 mg/5.600 i.e. tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 140 mikrogramov (5.600 i.e.) holekalciferola (vitamina D3).
English: BLISTER FOR FOSAVANCE 70 mg/2,800 IU
Slovenian: ŠKATLA ZA ZDRAVILO FOSAVANCE 70 mg/2.800 i.e.
English: Every week, take one FOSAVANCE tablet on your chosen day.
Slovenian: 1) Izberite dan v tednu, ki vam najbolj ustreza, nato pa vsak teden na izbrani dan vzemite eno tableto FOSAVANCE.
English: How to take FOSAVANCE
Slovenian: Kako jemati zdravilo FOSAVANCE
English: In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with FOSAVANCE.
Slovenian: Količina vitamina D v zdravilu FOSAVANCE ne zadošča za odpravo pomanjkanja vitamina D. Pri bolnikih s temi boleznimi je treba med zdravljenjem z zdravilom FOSAVANCE spremljati vrednost kalcija v serumu in simptome hipokalciemije.
English: EU/1/05/310/004 - 12 tablets
Slovenian: EU/1/05/310/007 - 4 tablete EU/1/05/310/008 - 12 tablet
English: These side effects may worsen if patients continue to take FOSAVANCE after developing these symptoms.
Slovenian: Če potem, ko so se že pojavili neželeni učinki, bolnik nadaljuje z jemanjem zdravila FOSAVANCE, se lahko neželeni učinki še poslabšajo.
English: FOSAVANCE 70 mg/2,800 IU tablets alendronic acid/colecalciferol
Slovenian: FOSAVANCE 70 mg/2.800 i.e. tablete alendronska kislina/holekalciferol
English: Very common (may affect more than 1 in 10 people):
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: BLISTER FOR FOSAVANCE 70 mg/5,600 IU
Slovenian: ŠKATLA ZA ZDRAVILO FOSAVANCE 70 mg/5.600 i.e.
English: FOSAVANCE 70 mg/5,600 IU tablets alendronic acid/colecalciferol
Slovenian: FOSAVANCE 70 mg/5.600 i.e. tablete alendronska kislina/holekalciferol
English: Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2,800 IU) colecalciferol (vitamin D3).
Slovenian: Ena tableta vsebuje 70 mg alendronske kisline (v obliki natrijevega trihidrata) in 70 mikrogramov (2.800 i.e.) holekalciferola (vitamin D3).
English: There is important additional information about how to take FOSAVANCE in the package leaflet.
Slovenian: V priloženem navodilu za uporabo so pomembne dodatne informacije o jemanju zdravila FOSAVANCE.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR FOSAVANCE 70 mg/2,800 IU
Slovenian: PRETISNI OMOT ZA ZDRAVILO FOSAVANCE 70 mg/2.800 i.e.
English: How to store FOSAVANCE
Slovenian: Shranjevanje zdravila FOSAVANCE
English: FOSAVANCE 70 mg/5,600 IU tablets alendronic acid /colecalciferol
Slovenian: 70 mg/5.600 i.e. tablete alendronska kislina/holekalciferol
English: Route of Administration
Slovenian: Jakost
English: This summary was last updated on 09/01/2007.
Slovenian: Ta povzetek je bil nazadnje posodobljen 09/01/2007.
English: Cortavance is given once a day for 7 days.
Slovenian: Zdravilo Cortavance se daje enkrat dnevno 7 dni.
English: If no improvement is seen after 7 days, the treatment should be re-evaluated by a veterinarian.
Slovenian: Če po 7 dneh ni izboljšanja, mora veterinar ponovno oceniti zdravljenje.
English: Do not smoke when applying this product.
Slovenian: Pri ravnanju z zdravilom ne kadite.
English: Fifty-four dogs were treated with Cortavance and 51 with this other product.
Slovenian: Štiriinpetdeset psov je bilo zdravljenih z zdravilom Cortavance, 51 pa s tem drugim zdravilom.
English: The treatment area should not normally exceed an area corresponding to the two flanks of the animal.
Slovenian: Obseg zdravljene površine običajno ne sme presegati površine, ki ustreza obema bočnima stranema živali.
English: Information on the prescription status of this product may be found on the label/outer package.
Slovenian: Informacije o predpisovanju tega izdelka najdete na nalepki/zunanji ovojnini.
English: Other information about Cortavance:
Slovenian: Druge informacije o zdravilu Cortavance:
English: It is sprayed on the affected area, avoiding the eyes.
Slovenian: Razprši se po prizadetem območju, vendar ne sme priti v stik z očmi.
English: The studies to determine the dose generally supported the chosen dose and the length of treatment.
Slovenian: Raziskave za določanje odmerka so v splošnem potrdile izbrani odmerek in dolžino zdravljenja.
English: In case of accidental contact (skin, eye), wash thoroughly with water.
Slovenian: V primeru nenamernega stika (koža, oko) mesto stika temeljito umijte z vodo.
English: The medicine should not normally be used in dogs suffering from Cushing's syndrome (a disorder where the body produces too much natural steroid), and in young animals (under 7 months of age) as steroids are known to slow growth.
Slovenian: Zdravilo se običajno ne uporablja pri psih s Cushingovim sindromom (motnja, pri kateri telo proizvede preveč naravnega steroida) in pri mladih živalih (ki še nimajo 7 mesecev), saj je znano, da steroidi upočasnjujejo rast.
English: The pump delivers in two sprays enough medicine to treat an area of about 100 cm2.
Slovenian: Z dvema sprožitvama črpalke dovedemo dovolj zdravila za zdravljenje površine velikosti približno 100 cm2.
English: Significant improvement of the skin condition was demonstrated in several studies under controlled conditions, whereas significant reduction of itching was demonstrated in only one of these laboratory studies in which the dogs received treatment against external parasites at the same time.
Slovenian: Bistveno izboljšanje stanja kože je bilo dokazano v več raziskavah pri kontroliranih pogojih, medtem ko je bilo bistveno zmanjšanje srbenja dokazano le v eni takšni laboratorijski raziskavi, v kateri so psi hkrati prejemali zdravilo proti zunanjim zajedavcem.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cortavance to Virback S.A. on 09/01/2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Cortavance, veljavno po vsej Evropski uniji, odobrila družbi Virbac S.A. dne 9. januarja 2007.