natgillin/translations-raw huggingface dataset:
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/ RENEWAL OF AUTHORISATION
ADROVANCE 70 mg/ 5600 IU tabletter
ADROVANCE 70 mg/ 5600 IU tablets
Hver tablet indeholder 70 mg alendronsyre som alendronatnatriumtrihydrat og 140 mikrogram (5600 IE) colecalciferol (D3- vitamin).
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3).
Hver tablet indeholder 63 mg vandfrit lactose og 16 mg saccharose.
Each tablet contains 63 mg lactose anhydrous and 16 mg sucrose.
Kapselformede, hvide/ beige tabletter, mærket med et omrids af en knogle på den ene side og ” 270 ” på den anden.
Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270 'on the other.
Behandling af postmenopausal osteoporose hos patienter, som ikke får tilskud af D- vitamin og med risiko for D- vitaminmangel.
Treatment of postmenopausal osteoporosis in patients who are not receiving vitamin D supplementation and are at risk of vitamin D insufficiency.
Den anbefalede dosis er én ADROVANCE tablet én gang ugentligt.
The recommended dosage is one ADROVANCE tablet once weekly.
• Patienten må ikke tygge eller opløse tabletten i munden, på grund af risiko for oropharyn - geale ulcerationer.
• Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
12 • Patienten må ikke ligge ned de første 30 minutter efter indtagelsen af ADROVANCE.
12 • Patients should not lie down for at least 30 minutes after taking ADROVANCE.
• ADROVANCE må ikke tages ved sengetid eller før patienten står op.
• ADROVANCE should not be taken at bedtime or before arising for the day.
Ækvivalensen mellem indtagelse af 5600 IE D3- vitamin ugentligt i ADROVANCE og daglig dosering af D- vitamin 800 IE er ikke undersøgt.
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.
• Overfølsomhed over for de aktive indholdsstoffer eller over for et eller flere af hjælpe - stofferne.
• Hypersensitivity to the active substances or to any of the excipients.
4. 8).
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).
14 Dette lægemiddel indeholder lactose og saccharose.
14 Excipients This medicinal product contains lactose and sucrose.
[Almindelig (≥1/ 100, < 1/ 10), ikke almindelig (≥1/ 1000, < 1/ 100), sjælden (≥1/ 10. 000, < 1/ 1000), meget sjælden (< 1/ 10. 000)].
[Common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1000), very rare (< 1/ 10,000)]
Nervesystemet:
15 Nervous system disorders:
15
Common: headache
Alvorlige hudreaktioner, inklusive Steven Johnsons syndrom og toksisk epidermal nekrolyse.
Uncommon: rash, pruritus, erythema Rare: rash with photosensitivity Very rare: severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Almindelig:
Metabolism and nutrition disorders:
Muskuloskeletale (knogle, muskel eller led) smerter.
General disorders and administration site conditions:
Alvorlige muskuloskeletale (knogle, muskel eller led) smerter (se pkt.
(see section 4.4) Rare: transient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment.
4. 4).
Rare: hypersensitivity reactions including urticaria and angioedema
Metabolisme og ernæring:
Nervous system disorders:
Sjælden:
dizziness
Immunsystemet:
Ear and labyrinth disorders:
Efter markedsføring er følgende
Skin and subcutaneous tissue disorders:
reaktioner rapporteret (hyppighed ukendt):
alopecia
Der er i kliniske undersøgelser
asthenia, peripheral oedema
4. 9 Overdosering
16 4.9 Overdose
På grund af risiko for esophageal irritation bør opkastning ikke induceres, og patienten skal forblive oprejst.
Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
16 Colecalciferol D- vitamin toksicitet er ikke blevet dokumenteret under kronisk behandling hos generelt raske voksne ved en dosis på mindre end 10. 000 IE/ dag.
Colecalciferol Vitamin D toxicity has not been documented during chronic therapy in generally healthy adults at a dose less than 10,000 IU/ day.
5. 2 Farmakodynamiske egenskaber
Pharmacodynamic properties
Gennemsnit, 56 nmol/ l [22, 3 ng/ ml]; variationsbredde, 22, 5- 225 nmol/ l [9- 90 ng/ ml]).
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]).
Patienterne fik den lavere styrke (70 mg/ 2800 IE) af ADROVANCE (n=350) eller FOSAMAX UGETABLET (alendronat) 70 mg (n=332) én gang ugentligt; yderligere D- vitamin tilskud var ikke tilladt.
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
Procentdelen af patienter med D- vitaminmangel (serum 25- hydroxyvitamin D < 37, 5 nmol/ l [< 15 ng/ ml]) var signifikant reduceret med 62, 5% med ADROVANCE (70 mg/ 2800 IE) versus alendronat alene (henholdsvis 12% versus 32%) efter uge 15.
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.
Procentdelen af patienter med D -
32%, respectively), through week 15.
17 vitaminmangel (serum 25- hydroxyvitamin D ≤22, 5 nmol/ l [≤9 ng/ ml]) var signifikant reduceret med 92% med ADROVANCE (70 mg/ 2800 IE) versus alendronat alene (henholdsvis 1% versus 13%).
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).
I denne undersøgelse øgedes de gennemsnitlige 25- hydroxyvitamin D niveauer hos patienter med D - vitaminmangel ved baseline (25- hydroxyvitamin D, 22, 5 til 37, 5 nmol/ l [9 til < 15 ng/ ml]) fra 30 nmol/ l (12, 1 ng/ ml) til 40 nmol/ l (15, 9 ng/ ml) ved uge 15 i ADROVANCE (70 mg/ 2800 IE) - gruppen (n=75) og faldt fra 30 nmol/ l (12, 0 ng/ ml) ved baseline til 26 nmol/ l (10, 4 ng/ ml) ved uge 15 i gruppen med alendronat alene (n=70).
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).
Effekten af den lavere dose af ADROVANCE (alendronat 70 mg/ D3- vitamin 2800 IE) plus yderligere 2800 IE D3- vitamin til i alt 5600 IE (mængden af D3- vitamin i den høje styrke af ADROVANCE) én gang ugentligt blev påvist i en 24 ugers ekstensionundersøgelse, der inkluderede 619 postmenopausale kvinder med osteoporose.
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.
Patienter i D3- vitamin 2800 gruppen fik ADROVANCE (70 mg/ 2800 IE) (n=299), og patienter i D3- vitamin 5600 gruppen fik ADROVANCE (70 mg/ 2800 IE) plus yderligere 2800 IE D3- vitamin (n=309) én gang ugentligt; yderligere D- vitamintilskud var tilladt.
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.
Efter 24 ugers behandling var de gennemsnitlige serum 25- hydroxyvitamin D niveauer signifikant højere i D3 - vitamin 5600 gruppen (69 nmol/ l [27, 6 ng/ ml] end i D3- vitamin 2800 gruppen (64 nmol/ l [25, 5 ng/ ml].
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]).
Procentdelen af patienter med D- vitaminmangel var 5, 4% i D3- vitamin 2800 gruppen versus 3, 2% i D3- vitamin 5600 gruppen gennem 24- ugers ekstensionsperioden.
3.2% in the Vitamin D3 5600 group through the 24-week extension.
Procentdelen af patienter med D - vitaminmangel var 0, 3% i D3- vitamin 2800 gruppen versus nul i D3- vitamin 5600 gruppen.
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.
Der var ingen forskelle i middel serumkalcium, phosphat eller 24- timers urinkalcium mellem behandlingsgrupperne.
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Procentdelen af patienter med hyperkalciuri ved slutningen af 24- ugers ekstensionsperioden var ikke statistisk signifikant mellem behandlingsgrupperne.
The percentage of patients with hypercalciuria at the end of the 24-week extension was not statistically different between treatment groups.
I denne undersøgelse reducerede alendronat 1 gang dagligt incidensen af ≥ 1 ny vertebral fraktur med 47% (alendronat 7, 9% versus placebo 15, 0%).
In this study alendronate daily reduced the incidence of ≥ 1 new 18 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
I denne undersøgelse observeredes en signifikant forskel i en analyse af subgruppen af osteoporotiske kvinder (37% af global population som havde osteoporose 18 svarende til ovennævnte definition) i incidensen af hoftefrakturer (alendronat 1, 0% versus placebo 2, 2%, en reduktion på 56%) og i incidensen af ≥ 1 vertebral fraktur (2, 9% versus 5, 8%, en reduktion på 50%).
5.8%, a reduction of 50%).
5. 2 Farmakokinetiske egenskaber
Pharmacokinetic properties
Alendronatkomponenten i ADROVANCE (70 mg/ 5600 IE) kombinationstabletten er bioekvivalent til alendronat i 70 mg tabletten.
The alendronate component in the ADROVANCE (70mg/ 5600 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
Colecalciferol
19 Colecalciferol
Absorption Ved administration af ADROVANCE 70 mg/ 5600 IE efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum- koncentration- tid (AUC0- 120 timer) for D3- vitamin (ikke justeret for endogene D3- vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 296, 4 ng time/ ml.
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.
Gennemsnitlig maksimal serumkoncentration (Cmax) for D3- vitamin var 5, 9 ng/ ml, og den gennemsnitlige tid til maksimal serumkoncentration (Tmax) var 12 timer.
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.
Biotilgængeligheden for 5600 IE D3- vitamin i ADROVANCE er lig med 5600 IE D3- vitamin, administreret alene.
The bioavailability of the 5600 IU vitamin D3 in ADROVANCE is similar to 5600 IU vitamin D3 administered alone.
19 Distribution Efter absorption går D3- vitamin ind i blodet som en del af chylomikronerne.
Distribution Following absorption, vitamin D3 enters the blood as part of chylomicrons.
Mindre mængder distribueres til det adipøse væv og muskelvævet og oplagres som D3- vitamin på disse steder for senere frigivelse til kredsløbet.
Lesser amounts are distributed to adipose and muscle tissue and stored as vitamin D3 at these sites for later release into the circulation.
20 Butylhydroxytoluen (E321) Modificeret majsstivelse Natriumaluminiumsilicat (E554)
PHARMACEUTICAL PARTICULARS
6. 2 Uforligeligheder
6.1 List of excipients
Forseglede aluminium/ aluminium blisterpakninger, i æsker med 2 (1 blisterpakning x 2 tabletter), 4 (1 blisterpakning x 4 tabletter), 12 (3 blisterpakninger x 4 tabletter) eller 40 (10 blisterpakninger x 4 tabletter) tabletter.
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.
MARKEDSFØRINGSTILLADELSESNUMRE (NUMRE)
MARKETING AUTHORISATION NUMBER(S)
EU/ 1/ 06/ 364/ 006 – 2 tabletter EU/ 1/ 06/ 364/ 007 – 4 tabletter EU/ 1/ 06/ 364/ 008 – 12 tabletter EU/ 1/ 06/ 364/ 009 – 40 tabletter
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
21 BILAG II
21 9.
FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
4 January 2007
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
DATE OF REVISION OF THE TEXT
22 A
22 ANNEX II
FREMSTLLER( E) ANSVARLIG( E) FOR
CONDITIONS OF THE MARKETING AUTHORISATION
BATCHFRIGIVELSE
23 A.
Via Complutense, 140 28805 Alcalá de Henares Madrid Spanien
Via Complutense, 140 ES-28805 Alcalá de Henares Madrid, Spain
B BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
CONDITIONS OF THE MARKETING AUTHORISATION
Pharmacovigilance system
Pharmacovigilance system
Indehaveren af markedsføringstilladelsen skal sikre sig, at pharmacovigilance systemet, som står beskrevet i version 2 i Modul 1. 8. 1 i ansøgningen om markedsføringstilladelse, er til stede og i brug før og medens produktet er på markedet.
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.
Risk Management plan
Risk Management Plan
Indehaveren af markedsføringstilladelsen er forpligtet til at udføre studier og nye pharmacovigilance aktiviteter beskrevet i Pharmacovigilance planen i overensstemmelse med version 2 af Risk Management Plan (RMP) beskrevet i Modul 1. 8. 2 i ansøgningen om markedsføringstilladelse samt alle de efterfølgende RMP- opdateringer, aftalt med CHMP.
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.
Ifølge CHMP guideline om Risk Management System for lægemidler til human brug, bør de opdaterede RMP indsendes samtidig med den næste sikkerhedsopdateringsraport (PSUR).
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).
Yderligere, bør en opdateret RMP indsendes • Når der modtages ny information, der har indvirkning på den gældende sikkerhedsspecifikation, Pharmacovigilance plan eller risiko minimeringsaktiviteterne • Inden 60 dage, når en vigtig (pharmacovigilance eller risiko minimering) milepæl opnås • Ved anmodning fra EMEA
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
PSUR' er
PSURs
PSUR cyklusen for ADROVANCE er på line med produktet FOSAVANCE indtil andet aftales.
The PSUR cycle of ADROVANCE is aligned with the one of the product, FOSAVANCE, until otherwise specified.
ETIKETTERING
LABELLING AND PACKAGE LEAFLET
25 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
LABELLING
YDRE EMBALLAGE – KARTON TIL 1, 3 eller 10 BLISTERPAKNING MED 2 eller 4 TABLETTER
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
ADROVANCE 70 mg/ 2800 IE tabletter Alendronsyre som alendronatnatriumtrihydrat/ colecalciferol
ADROVANCE 70 mg/ 2800 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
70 mg alendronsyre som alendronatnatriumtrihydrat og 70 mikrogram (2800 IE) colecalciferol (D3 - vitamin)
70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D3.).
Vandfrit lactose og saccharose.
Also contains: lactose anhydrous and sucrose.
2 tabletter 4 tabletter 6 tabletter 12 tabletter 40 tabletter.
2 tablets 4 tablets 6 tablets 12 tablets 40 tablets
Skal tages én gang ugentligt, og på den samme dag hver uge.
For oral use To be taken once weekly, on the same day each week.
Ugetablet.
Once weekly
26 Opbevares i den originale blisterpakning for at beskytte mod fugt og lys.
Store in the original blister in order to protect from moisture and light.
EU/ 1/ 06/ 364/ 001 (2 tabletter) EU/ 1/ 06/ 364/ 002 (4 tabletter) EU/ 1/ 06/ 364/ 003 (6 tabletter) EU/ 1/ 06/ 364/ 004 (12 tabletter) EU/ 1/ 06/ 364/ 005 (40 tabletter)
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)
ADROVANCE 70 mg 2800 IE
ADROVANCE 70 mg 2800 IU
27 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
INDRE EMBALLAGE – BLISTERPAKNING MED 2 eller 4 TABLETTER
IMMEDIATE PACKAGING – TRIFOLD PACK OF 2 or 4 TABLETS
2 tabletter 4 tabletter.
2 tablets 4 tablets
Hvordan De skal tage ADROVANCE tabletterne
How to take ADROVANCE tablets
Vælg den ugedag, der passer Dem bedst.
Choose the day of the week that best fits your schedule.
Når De står op på den valgte ugedag, og før De indtager dagens første måltid, drikkevarer eller anden medicin, skal de sluge (ikke tygge eller sutte) én ADROVANCE tablet med et helt glas postevand (ikke mineralvand).
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).
Fortsæt med Deres morgenaktiviteter.
Continue your morning activities.
De kan sidde, stå eller gå – blot De forbliver oprejst.
You can sit, stand or walk – just stay fully upright.
De må ikke lægge Dem ned, spise, drikke eller tage anden medicin i mindst 30 minutter.
Don ’ t lie down, eat, drink or take other medicines for at least 30 minutes.
De må ikke lægge Dem ned, før de har fået dagens første måltid.
Do not lie down until after your first food of the day.
Husk at tage ADROVANCE én gang om ugen på den samme ugedag, så længe Deres læge foreskriver det.
Remember, take ADROVANCE once each week on that same day for as long as your doctor prescribes it.
Hvis De glemmer en tablet, skal De blot tage en ADROVANCE tablet om morgenen, efter De er kommet i tanke om det.
If you miss a dose, take only one ADROVANCE tablet on the morning after you remember.
Fortsæt med at tage én tablet om ugen, på den ugedag, De oprindeligt har valgt.
Return to taking one tablet once a week, as originally scheduled on your chosen day.
Der er yderligere vigtige informationer om, hvordan De skal tage ADROVANCE i den medfølgende indlægsseddel.
There is important additional information about how to take ADROVANCE in the enclosed package leaflet.
Tag 1 tablet 1 gang ugentligt.
29 Take one tablet once a week
28 Markér den ugedag, der passer Dem bedst:
Mark the day of the week that best fits your schedule:
MA FR TI LØ ON SØ TO
MON FRI TUE SAT WED SUN THU
UGE 1.
WEEK 1.
Dato: _____ UGE 2.
Date: ____ WEEK 2.
Dato: _____ UGE 3.
Date: _____ WEEK 3.
Dato: _____ UGE 4.
Date: ____ WEEK 4.
Dato: _____ TID TIL NY RECEPT
Date: _____ TIME TO REFILL
Sæt et klistermærke i Deres kalender for at huske at tage Deres ADROVANCE.
For your convenience, place a sticker on your calendar each week as a reminder to take your ADROVANCE.
ADROVANCE UGE 1 ADROVANCE UGE 2 ADROVANCE UGE 3 ADROVANCE UGE 4 TID TIL NY RECEPT
ADROVANCE WEEK 1 ADROVANCE WEEK 2 ADROVANCE WEEK 3 ADROVANCE WEEK 4 TIME TO REFILL
Tryk tabletten igennem fra denne side.
To remove, push tablets through from this side.
Tryk tabletten igennem fra den anden side.
To remove, push tablets through from other side.
Ugetablet
Once weekly
29 Merck Sharp & Dohme Ltd.
Merck Sharp & Dohme Ltd.
EU/ 1/ 06/ 364/ 001 (2 tabletter) EU/ 1/ 06/ 364/ 002 (4 tabletter) EU/ 1/ 06/ 364/ 003 (6 tabletter) EU/ 1/ 06/ 364/ 004 (12 tabletter) EU/ 1/ 06/ 364/ 005 (40 tabletter)
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)
30 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE – KARTON TIL 1, 3 eller 10 BLISTERPAKNING MED 2 eller 4 TABLETTER
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING – CARTON FOR 1, 3 or 10 TRIFOLD PACK OF 2 or 4 TABLETS
ADROVANCE 70 mg/ 5600 IE tabletter Alendronsyre som alendronatnatriumtrihydrat/ colecalciferol
ADROVANCE 70 mg/ 5600 IU tablets Alendronic acid as alendronate sodium trihydrate/ colecalciferol
70 mg alendronsyre som alendronatnatriumtrihydrat og 140 mikrogram (5600 IE) colecalciferol (D3 - vitamin)
70 mg alendronic acid as alendronate sodium trihydrate and 140 micrograms (5600 IU) colecalciferol (vitamin D3.).
2 tabletter 4 tabletter 12 tabletter 40 tabletter.
2 tablets 4 tablets 12 tablets 40 tablets
31 Opbevares i den originale blisterpakning for at beskytte mod fugt og lys.
Store in the original blister in order to protect from moisture and light.
EU/ 1/ 06/ 364/ 006 (2 tabletter) EU/ 1/ 06/ 364/ 007 (4 tabletter) EU/ 1/ 06/ 364/ 008 (12 tabletter) EU/ 1/ 06/ 364/ 009 (40 tabletter).
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)
ADROVANCE 70 mg 5600 IE
ADROVANCE 70 mg 5600 IU
32 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Tag 1 tablet 1 gang ugentligt.
34 Take one tablet once a week
33 Markér den ugedag, der passer Dem bedst:
Mark the day of the week that best fits your schedule:
ADROVANCE UGE 1 ADROVANCE UGE 2 ADROVANCE UGE 3 ADROVANCE UGE 4TID TIL NY RECEPT
ADROVANCE WEEK 1 ADROVANCE WEEK 2 ADROVANCE WEEK 3 ADROVANCE WEEK 4 TIME TO REFILL
34 Merck Sharp & Dohme Ltd.
Merck Sharp & Dohme Ltd.
EU/ 1/ 06/ 364/ 006 (2 tabletter) EU/ 1/ 06/ 364/ 007 (4 tabletter) EU/ 1/ 06/ 364/ 008 (12 tabletter) EU/ 1/ 06/ 364/ 009 (40 tabletter)
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)
35 B.
--
36 INDLÆGSSEDDEL:
PACKAGE LEAFLET
Læs denne indlægsseddel grundigt, inden De begynder at tage medicinen.
Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.
- Spørg lægen eller på apoteket, hvis der er mere De vil vide.
- If you have any further questions, ask your doctor or pharmacist.
- Lægen har ordineret ADROVANCE til Dem personligt.
- This medicine has been prescribed for you.
Lad derfor være med at give det til
It may harm them, even if
Det kan være skadeligt for andre, selvom de har de samme symptomer, som De har.
their symptoms are the same as yours.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
3.
- It is particularly important to understand the information in section 3.
SÅDAN SKAL DE TAGE ADROVANCE,
HOW TO TAKE
før De tager dette lægemiddel.
ADROVANCE, before taking this medicine.
Oversigt over indlægssedlen 1.
In this leaflet:
ADROVANCEs virkning og hvad De skal bruge det til 2.
3.
Bivirkninger 5.
5 6.