natgillin/translations-raw huggingface dataset:
The relevance to humans is unknown.
Pomen le- tega za ljudi ni poznan.
Colecalciferol At doses far higher than the human therapeutic range, reproductive toxicity has been observed in animal studies.
Holekalciferol Pri odmerkih, ki daleč presegajo terapevtsko območje pri ljudeh, so v raziskavah na živalih ugotovili toksični učinek na reprodukcijo.
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)
10 6.2 Incompatibilities
6. 2 Inkompatibilnosti
6.5 Nature and contents of container
10 6. 5 Vrsta ovojnine in vsebina
Wallet with sealed aluminium/ aluminium blisters, in cartons containing 2 (1 wallet x 2 tablets), 4 (1 wallet x 4 tablets), 6 (3 wallets x 2 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets.
Zgibanka s pretisnimi omoti (aluminij/ aluminij) v škatli, ki vsebuje 2 (1 zgibanko x 2 tableti), 4 (1 zgibanko x 4 tablete), 6 (3 zgibanke x 2 tableti), 12 (3 zgibanke x 4 tablete) ali 40 (10 zgibank x 4 tablete) tablet.
MARKETING AUTHORISATION HOLDER(S)
IMETNIK DOVOLJENJA ZA PROMET
EU/ 1/ 06/ 364/ 001 – 2 tablets EU/ 1/ 06/ 364/ 002 – 4 tablets EU/ 1/ 06/ 364/ 003 – 6 tablets EU/ 1/ 06/ 364/ 004 – 12 tablets EU/ 1/ 06/ 364/ 005 – 40 tablets
EU/ 1/ 06/ 364/ 001 – 2 tableti EU/ 1/ 06/ 364/ 002 – 4 tablete EU/ 1/ 06/ 364/ 003 – 6 tablet EU/ 1/ 06/ 364/ 004 – 12 tablet EU/ 1/ 06/ 364/ 005 – 40 tablet
DATE OF FIRST AUTHORISATION/ RENEWAL OF AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
4 January 2007
4. januar 2007
ADROVANCE 70 mg/ 5600 IU tablets
ADROVANCE 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).
Each tablet contains 63 mg lactose anhydrous and 16 mg sucrose.
Vsaka tableta vsebuje 63 mg brezvodne laktoze in 16 mg saharoze.
Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270 'on the other.
Tablete v obliki podobni pravokotniku, bele do skoraj bele barve, ki imajo na eni strani vtisnjen obris kosti, na drugi pa oznako '270'.
Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin D supplementation and are at risk of vitamin D insufficiency.
Zdravljenje pomenopavzalne osteoporoze pri bolnikih, ki ne prejemajo dodatka vitamina D in imajo tveganje za pomanjkanje vitamina D.
The recommended dosage is one ADROVANCE tablet once weekly.
Priporočeni odmerek je ena tableta ADROVANCE enkrat tedensko.
• Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
12 • bolnik se ne sme uleči, dokler ne zaužije prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete,
12 • Patients should not lie down for at least 30 minutes after taking ADROVANCE.
• bolnik se še vsaj 30 minut po zaužitju tablete ADROVANCE ne sme uleči,
• ADROVANCE should not be taken at bedtime or before arising for the day.
• bolnik zdravila ADROVANCE ne sme vzeti pred spanjem ali preden zjutraj vstane.
The equivalence of intake of 5600 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 800 IU has not been studied.
Ekvivalent vnosa 5. 600 i. e. vitamina D3 tedensko v zdravilu ADROVANCE dnevnemu odmerjanju vitamina D 800 i. e. ni bil preučevan.
13 While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8).
V obdobju trženja zdravila so redko poročali o razjedah v želodcu in dvanajstniku (nekatere so bile resne in s komplikacijami) (glejte poglavje 4. 8).
14 Excipients This medicinal product contains lactose and sucrose.
14 Pomožne snovi To zdravilo vsebuje laktozo in saharozo.
15 Nervous system disorders:
Pogosti: glavobol Bolezni živčevja
Rare: hypersensitivity reactions including urticaria and angioedema
astenija, periferni edemi Splošne težave in spremembe na mestu aplikacije
Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
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, but such cases have also been reported in patients treated for osteoporosis.
10%, pri bolnikih, ki so jemali placebo, pa za približno 12% oz.
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
3%.
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4); joint swelling.
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.
asthenia, peripheral oedema
4. 9 Preveliko odmerjanje
Laboratory test findings In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking alendronate 10 mg/ day versus approximately 12% and 3% of those taking placebo.
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.
16 4.9 Overdose
16 Posebnih napotkov o ukrepih pri prekomernem odmerjanju alendronata ni na voljo.
No specific information is available on the treatment of overdose with alendronate.
Če bolnik vzame prekomeren odmerek zdravila ADROVANCE, naj pije mleko ali vzame antacid, ki vežeta alendronat.
In case of overdose with ADROVANCE, milk or antacids should be given to bind alendronate.
Zaradi nevarnosti draženja požiralnika se bruhanja ne sme izzvati.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Bolnik mora ostati v popolnoma vzravnanem položaju.
Bisphosphonates, combinations, ATC code:
Difosfonati, kombinacije Oznaka ATC:
ADROVANCE studies The effect of the lower dose of ADROVANCE (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 ADROVANCE Vpliv nižjega odmerka zdravila ADROVANCE (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 ADROVANCE (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 ADROVANCE (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 ADROVANCE (70 mg/ 2800 IU) group (56 nmol/ l [23 ng/ ml]) than in the alendronate-only group (46 nmol/ l [18.2 ng/ ml]).
Delež bolnic s
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 ADROVANCE (70 mg/ 2800 IU) vs. alendronate-only (12% vs.
17 pomanjkanjem vitamina D (serumski 25- hidroksivitamin D < 37, 5 nmol/ l [< 15 ng/ mol]) je bil v skupini, ki je prejemala ADROVANCE (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 ADROVANCE (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 ADROVANCE (70 mg/ 2. 800 i. e.) pomembno nižji (za 92%) kot v skupini, ki je prejemala le alendronat (1% oz.
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 ADROVANCE (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 ADROVANCE (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 ADROVANCE (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 ADROVANCE) once weekly was demonstrated in a 24-week, extension study that enrolled 619 osteoporotic post-menopausal women.
(vrednost vitamina D3 v višjem odmerku zdravila ADROVANCE) 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 ADROVANCE (70 mg/ 2800 IU) (n=299) and patients in the Vitamin D3 5600 group received ADROVANCE (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 ADROVANCE (70 mg/ 2800 i. e.) (n=299), bolnice v skupini "Vitamin D3 5. 600" pa so prejemale ADROVANCE (70 mg/ 2800 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]).
3.2% in the Vitamin D3 5600 group through the 24-week extension.
Tekom raziskave je bil delež bolnic s pomanjkanjem vitamina D 5, 4% v skupini "Vitamin D3 2. 800" in 3, 2% v skupini "Vitamin D3 5. 600".
The percentage of patients with vitamin D deficiency was 0.3% in the Vitamin D3 2800 group vs. zero in the Vitamin D3 5600 group.
Delež bolnic s hudim pomanjkanjem vitamina D je bil 0, 3% v skupini "Vitamin D3 2. 800" in 0% v skupini "Vitamin D3 5. 600".
The percentage of patients with hypercalciuria at the end of the 24-week extension was not statistically different between treatment groups.
Po 24 tedenskem podaljšku deleža bolnic s hiperkalceurijo v obeh skupinah nista bila statistično različna.
In this study alendronate daily reduced the incidence of ≥ 1 new 18 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
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
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.
Biološka uporabnost se je pri zaužitju alendronata eno uro ali pol ure pred standardiziranim zajtrkom podobno zmanjšala na ocenjenih 0, 46% in 0, 39%.
The alendronate component in the ADROVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Alendronat v kombinirani tableti ADROVANCE (70 mg/ 5. 600 i. e.) je bioekvivalenten alendronatu v 70 mg tableti.
19 Colecalciferol
19 Holekalciferol
Absorption In healthy adult subjects (males and females), following administration of ADROVANCE 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 ADROVANCE 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 mean maximal serum concentration (Cmax) of vitamin D3 was 12.2 ng/ ml and the median time to maximal serum concentration (Tmax) was 10.6 hours.
Povprečna maksimalna serumska koncentracija (Cmax) vitamina D3 je znašala 12, 2 ng/ ml, mediana časa do maksimalne serumske koncentracije (Tmax) pa je bila 10, 6 ur.
The bioavailability of the 5600 IU vitamin D3 in ADROVANCE is similar to 5600 IU vitamin D3 administered alone.
Biološka uporabnost 5. 600 i. e. vitamina D3 v zdravilu ADROVANCE je podobna kot pri zaužitju samo 5. 600 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 4, 9%.
Wallet with sealed aluminium/ aluminium blisters, in cartons containing 2 (1 wallet x 2 tablets), 4 (1 wallet x 4 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets.
Zgibanka s pretisnimi omoti (aluminij/ aluminij) v škatli, ki vsebuje 2 (1 zgibanko x 2 tableti), 4 (1 zgibanko x 4 tablete), 12 (3 zgibanke x 4 tablete) ali 40 (10 zgibank x 4 tablete) tablet.
EU/ 1/ 06/ 364/ 006 – 2 tablets EU/ 1/ 06/ 364/ 007 – 4 tablets EU/ 1/ 06/ 364/ 008 – 12 tablets EU/ 1/ 06/ 364/ 009 – 40 tablets
EU/ 1/ 06/ 364/ 006 – 2 tableti EU/ 1/ 06/ 364/ 007 – 4 tablete EU/ 1/ 06/ 364/ 008 – 12 tablet EU/ 1/ 06/ 364/ 009 – 40 tablet
22 ANNEX II
22 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
23 A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Via Complutense, 140 ES-28805 Alcalá de Henares Madrid, Spain
Via Complutense, 140 ES- 28805 Alcalá de Henares Madrid, Španija
CONDITIONS OF THE MARKETING AUTHORISATION
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
The MAH must ensure that the system of pharmacovigilance, as described in version 2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance (kot je opisano v različici 2, predstavljeni v modulu 1. 8. 1 Vloge za izdajo dovoljenja za promet z zdravilom) vzpostavljen in deluje preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 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).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Sočasno z naslednjim Periodičnim poročilom o varnosti zdravila (PSUR) je potrebno predložiti dopolnjen Načrt upravljanja tveganja v skladu s Smernicami za sisteme upravljanja tveganja pri zdravilih za uporabo v humani medicini Odbora za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Prav tako je potrebno dopolnjen Načrt upravljanja tveganja predložiti: • ko je pridobljena nova informacija, ki bi lahko vplivala na trenutni varnostni profil, farmakovigilančni plan ali postopke za zmanjšanje tveganja • v roku 60 dni od prepoznanega pomembnega mejnika (farmakovigilančnega ali za zmanjšanje tveganja) • na zahtevo Evropske agencije za zdravila in medicinske pripomočke (EMEA)
24 ANNEX III
24 DODATEK III
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
ZUNANJA OVOJNINA – ŠKATLA ZA 1, 3 ali 10 ZGIBANK Z 2 ali 4 TABLETAMI
ADROVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
ADROVANCE 70 mg/ 2. 800 i. e. tablete Alendronska kislina v obliki natrijevega alendronata trihidrata/ holekalciferol
70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D3.).
70 mg alendronske kisline v obliki natrijevega alendronata trihidrata in 70 mikrogramov (2. 800 i. e.) holekalciferola (vitamin D3).
Also contains: lactose anhydrous and sucrose.
Vsebuje tudi: brezvodno laktozo in saharozo.
2 tablets 4 tablets 6 tablets 12 tablets 40 tablets
2 tableti 4 tablete 6 tablet 12 tablet 40 tablet
For oral use To be taken once weekly, on the same day each week.
Vzemite enkrat tedensko, na isti dan v tednu.
Once weekly
Enkrat tedensko
EU/ 1/ 06/ 364/ 001(2 tablets) EU/ 1/ 06/ 364/ 002 (4 tablets) EU/ 1/ 06/ 364/ 003 (6 tablets) EU/ 1/ 06/ 364/ 004 (12 tablets) EU/ 1/ 06/ 364/ 005 (40 tablets)
EU/ 1/ 06/ 364/ 001 (2 tableti) EU/ 1/ 06/ 364/ 002 (4 tablete) EU/ 1/ 06/ 364/ 003 (6 tablet) EU/ 1/ 06/ 364/ 004 (12 tablet) EU/ 1/ 06/ 364/ 005 (40 tablet)
ADROVANCE 70 mg 2800 IU
ADROVANCE 70 mg 2. 800 i. e.
28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
28 PODATKI NA PRIMARNI OVOJNINI
IMMEDIATE PACKAGING – TRIFOLD PACK OF 2 or 4 TABLETS
STIČNA OVOJNINA – ZGIBANKA Z 2 ali 4 TABLETAMI
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 ADROVANCE 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 ADROVANCE 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.
Do not lie down until after your first food of the day.
Ne uležite se, dokler ne pojeste prvega dnevnega obroka hrane.
Remember, take ADROVANCE once each week on that same day for as long as your doctor prescribes it.
Zapomnite si - ADROVANCE 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 ADROVANCE in the enclosed package leaflet.
V priloženem navodilu za uporabo so pomembne dodatne informacije o jemanju zdravila ADROVANCE.
29 Take one tablet once a week
29 Vzemite eno tableto enkrat na teden
Mark the day of the week that best fits your schedule:
Označite dan v tednu, ki vam najbolj ustreza:
MON FRI TUE SAT WED SUN THU
PON PET TOR SOB SRE NED ČET
WEEK 1.
TEDEN 1.
Date: ____ WEEK 2.
Datum: _____ TEDEN 2.
Date: _____ WEEK 3.
Datum: _____ TEDEN 3.
Date: ____ WEEK 4.
Datum: _____ TEDEN 4.
Date: _____ TIME TO REFILL
Datum: _____ TREBA JE PO NOV RECEPT:
For your convenience, place a sticker on your calendar each week as a reminder to take your ADROVANCE.
Da se boste lažje spomnili, kdaj je treba vzeti ADROVANCE, na koledar nalepite nalepko za vsak teden.
ADROVANCE WEEK 1 ADROVANCE WEEK 2 ADROVANCE WEEK 3 ADROVANCE WEEK 4 TIME TO REFILL
ADROVANCE TEDEN 1 ADROVANCE TEDEN 2 ADROVANCE TEDEN 3 ADROVANCE TEDEN 4 TREBA JE PO NOV RECEPT
To remove, push tablets through from this side.
Tableto vzemite iz ovojnine tako, da jo potisnete s te strani.
To remove, push tablets through from other side.
Tableto vzemite iz ovojnine tako, da jo potisnete z druge strani.
EU/ 1/ 06/ 364/ 001 (2 tablets) EU/ 1/ 06/ 364/ 002 (4 tablets) EU/ 1/ 06/ 364/ 003 (6 tablets) EU/ 1/ 06/ 364/ 004 (12 tablets) EU/ 1/ 06/ 364/ 005 (40 tablets)
EU/ 1/ 06/ 364/ 001 (2 tableti) EU/ 1/ 06/ 364/ 002 (4 tablete) EU/ 1/ 06/ 364/ 003 (6 tablet) EU/ 1/ 06/ 364/ 004 (12 tablet) EU/ 1/ 06/ 364/ 005 (40 tablet)
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
ZUNANJA OVOJNINA – ŠKATLA ZA 1, 3 ali 10 ZGIBANK Z 2 ali 4 TABLETAMI
ADROVANCE 70 mg/ 5600 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
ADROVANCE 70 mg/ 5. 600 i. e. tablete Alendronska kislina v obliki natrijevega alendronata trihidrata in holekalciferol
70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3.).
70 mg alendronske kisline v obliki natrijevega alendronata trihidrata in 140 mikrogramov (5. 600 i. e.) holekalciferola (vitamin D3).
2 tablets 4 tablets 12 tablets 40 tablets
2 tableti 4 tablete 12 tablet 40 tablet
EU/ 1/ 06/ 364/ 006 (2 tablets) EU/ 1/ 06/ 364/ 007 (4 tablets) EU/ 1/ 06/ 364/ 008 (12 tablets) EU/ 1/ 06/ 364/ 009 (40 tablets)
EU/ 1/ 06/ 364/ 006 (2 tableti) EU/ 1/ 06/ 364/ 007 (4 tablete) EU/ 1/ 06/ 364/ 008 (12 tablet) EU/ 1/ 06/ 364/ 009 (40 tablet)
ADROVANCE 70 mg 5600 IU
ADROVANCE 70 mg 5. 600 i. e.
33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
33 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
34 Take one tablet once a week
Vzemite eno tableto enkrat na teden 34 Označite dan v tednu, ki vam najbolj ustreza:
37 PACKAGE LEAFLET:
37 NAVODILO ZA UPORABO
ADROVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
ADROVANCE 70 mg/ 2. 800 i. e. tablete alendronska kislina v obliki natrijevega alendronata trihidrata/ holekalciferol
Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.
Pred začetkom jemanja natančno preberite navodilo!
their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
- It is particularly important to understand the information in section 3.
- Zelo pomembno je, da pred začetkom jemanja razumete navodila v poglavju 3.
HOW TO TAKE
KAKO JEMATI
ADROVANCE, before taking this medicine.
ZDRAVILO ADROVANCE.
2.
Kaj je zdravilo ADROVANCE in za kaj ga uporabljamo 2.
3.
Kaj morate vedeti, preden boste vzeli zdravilo ADROVANCE 3.
4.
Kako jemati zdravilo ADROVANCE 4.
5 6.
Možni neželeni učinki 5.