natgillin/translations-raw huggingface dataset:
Meget sjælden:
Common: musculoskeletal (bone, muscle or joint) pain Rare: severe musculoskeletal (bone, muscle or joint) pain (see section 4.4) Rare: symptomatic hypocalcaemia, often in association with predisposing conditions.
Alvorlige hudreaktioner, inklusive Steven Johnsons syndrom og toksisk epidermal nekrolyse.
(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.
Knogler, led, muskler og bindevæv:
Rare: hypersensitivity reactions including urticaria and angioedema
Muskuloskeletale (knogle, muskel eller led) smerter.
During post-marketing experience the following reactions have been reported (frequency not known):
Sjælden:
Nervous system disorders:
4. 4).
dizziness
Metabolisme og ernæring:
Ear and labyrinth disorders:
Sjælden:
vertigo
Almene symptomer og reaktioner på administrationsstedet:
Skin and subcutaneous tissue disorders:
Sjælden:
alopecia
Knogler, led, muskler og bindevæv:
Musculoskeletal, connective tissue and bone disorders:
Kæbeosteonekrose er rapporteret hos patienter, der er behandlet med bisphosphonater.
Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Størstedelen af rapporterne refererer til cancerpa - tienter, men sådanne tilfælde har også været rapporteret for patienter, der er behandlet for osteoporose.
The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Kæbeosteonekrose er normalt asso - cieret med tandudtrækning og/ eller lokal infektion (inklusive osteo - myelitis).
Osteonecrosis of the jaw is generally associated with tooth extraction and / or local infection (including osteomyelitis).
4. 4); ledhævelse.
Diagnosis of cancer, chemotherapy, radiotherapy, corticosteroids and poor oral hygiene are also deemed as risk factors (see section 4.4); joint swelling.
Asteni, perifert ødem.
asthenia, peripheral oedema
12% og 3% af de patienter, der fik placebo.
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.
Imidlertid var incidensen af fald i serumkalcium til < 8, 0 mg/ dl (2, 0 mmol/ l) og serumfosfat til ≤ 2, 0 mg/ dl (0, 65 mmol/ l) ens i begge behandlingsgrupper.
However, the incidences of decreases in serum calcium to < 8.0 mg/ dl (2.0 mmol/ l) and serum phosphate to ≤ 2.0 mg/ dl (0.65 mmol/ l) were similar in both treatment groups.
4. 9 Overdosering
6 4.9 Overdose
Alendronat Overdosering kan forårsage hypokalcæmi, hypophosphatæmi og øvre gastrointestinale bivirkninger som mavebesvær, halsbrand, esophagitis, gastritis eller ulcus.
Alendronate Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
På
In case of overdose with ADROVANCE, milk or antacids should be given to bind alendronate.
6 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.
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.
I en klinisk undersøgelse med raske voksne blev en D3 - vitamin dosis på 4. 000 IE/ dag givet i op til fem måneder ikke forbundet med hyperkalciuri eller hyperkalcæmi.
In a clinical study of healthy adults a 4000 IU daily dose of vitamin D3 for up to five months was not associated with hypercalciuria or hypercalcaemia.
5. 1 Farmakodynamiske egenskaber
Pharmacodynamic properties
ATC- kode:
Bisphosphonates, combinations, ATC code:
M05BB03.
M05BB03.
alendronatnatriumtrihydrat og colecalciferol (D3- vitamin).
ADROVANCE is a combination tablet containing the two active substances alendronate sodium trihydrate and colecalciferol (vitamin D3).
Alendronat Alendronat natrium er et bisphosphonat, der hæmmer osteoklasters knogleresorption uden direkte effekt på knogleopbygningen.
Alendronate Alendronate sodium is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation.
Colecalciferol (D3- vitamin) D3- vitamin dannes i huden ved omdannelse af 7- dehydrocholesterol til D3- vitamin ved hjælp af ultraviolet lys.
Colecalciferol (vitamin D3) Vitamin D3 is produced in the skin by conversion of 7-dehydrocholesterol to vitamin D3 by ultraviolet light.
Ved mangel på tilstrækkelig eksponering for sollys er D3- vitamin et væsentligt kosttilskud.
In the absence of adequate sunlight exposure, vitamin D3 is an essential dietary nutrient.
D3- vitamin omdannes til 25- hydroxyvitamin D3 i leveren og lagres indtil der er brug for det.
Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver, and stored until needed.
Omdannelse til det aktive kalcium- mobiliserende hormon 1, 25- dihydroxyvitamin D3 (calcitriol) i nyrerne reguleres stramt.
Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is tightly regulated.
Den vigtigste funktion for 1, 25 dihydroxyvitamin D3 er at øge den intestinale absorption af både kalcium og fosfat såvel som at regulere serumkalcium, renal kalcium og fosfatudskillelsen, knogleopbygningen og knogleresorptionen.
The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.
D3- vitamin er nødvendig for den normale knogleopbygning.
Vitamin D3 is required for normal bone formation.
D- vitaminmangel udvikles, når både eksponering for sollys og indtaget gennem kosten er utilstrækkelig.
Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate.
Insufficiens er forbundet med negativ kalciumbalance, knogletab og øget risiko for knoglefraktur.
Insufficiency is associated with negative calcium balance, bone loss, and increased risk of skeletal fracture.
Yderligere forøges risiko for fald og fraktur hos osteoporosepatienter.
In severe cases, deficiency results in secondary hyperparathyroidism, hypophosphataemia, proximal muscle weakness and osteomalacia, further increasing the risk of falls and fractures in osteoporotic individuals.
Osteoporosis er defineret som knoglemineraltætheden (BMD) for columna spinalis eller hofte på 2, 5 standarddeviationer (SD) under middelværdien for en normal ung population eller som tidligere skørhedsfraktur uden hensyntagen til BMD.
Osteoporosis is defined as bone mineral density (BMD) of the spine or hip 2.5 standard deviations (SD) below the mean value of a normal young population or as a previous fragility fracture, irrespective of BMD.
Gennemsnit, 56 nmol/ l [22, 3 ng/ ml]; variationsbredde, 22, 5- 225 nmol/ l [9- 90 ng/ ml]).
ADROVANCE studies The effect 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 D supplements
Efter 15 ugers behandling var de gennemsnitlige serum 25- hydroxyvitamin D niveauer signifikant højere (26%) i ADROVANCE (70 mg/ 2800 IE) gruppen (56 nmol/ l [23 ng/ ml]) end i gruppen med alendronat alene (46 nmol/ l [18, 2 ng/ ml]).
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]).
Procentdelen af patienter med D- vitaminmangel (serum 25- hydroxyvitamin D < 37, 5 nmol/ l
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.
7 [< 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.
32%, respectively), through week 15.
Procentdelen af patienter med D - 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).
Der var ingen forskel i middel serumkalcium, fosfat eller 24 timers urinkalcium mellem behandlingsgrupperne.
There were no differences in mean serum calcium, phosphate, or 24-hour urine calcium between treatment groups.
Alendronat undersøgelser Den terapeutiske ekvivalens for alendronat 70 mg en gang ugentligt (n=519) og alendronat 10 mg dagligt (n=370) blev påvist i en 1- årig multicenterundersøgelse med postmenopausale kvinder med osteoporose.
Alendronate studies The therapeutic equivalence of alendronate once weekly 70 mg (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis.
Den gennemsnitlige øgning fra baseline i columna lumbalis efter et år var 5, 1% (95% CI:
The mean increases from baseline in lumbar spine BMD at one year were 5.1% (95% CI:
4, 8, 5, 4%) i den gruppe, der fik 70 mg ugentligt, og 5, 4% (95% CI:
4.8, 5.4%) in the 70 mg once-weekly group and 5.4% (95% CI:
5, 0, 5, 8%) i den gruppe, der fik 10 mg dagligt.
5.0, 5.8%) in the 10 mg daily group.
Gennemsnitlige forhøjelser af BMD var 2, 3% og 2, 9% ved collum femoris og 2, 9% og 3, 1% i hele hoften i henholdsvis 70 mg gruppen og 10 mg gruppen.
The mean BMD increases were 2.3% and 2.9% at the femoral neck and 2.9% and 3.1% at the total hip in the 70 mg once weekly and 10 mg daily groups, respectively.
Effekten af alendronat på knoglemasse og frakturincidens hos postmenopausale kvinder blev undersøgt i to initiale effektundersøgelser med identisk design (n=994) samt i undersøgelsen ” Fracture Intervention Trial ” (FIT: n=6. 459).
The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).
I de initiale effektundersøgelser, efter 3 års behandling med alendronat 10 mg dagligt, var de gennemsnitlige stigninger i BMD på henholdsvis 8, 8%, 5, 9% og 7, 8% i columna spinalis, colum femoris og trochanter, sammenlignet med placebo.
In the initial efficacy studies, the mean BMD increases with alendronate 10 mg/ day relative to placebo at three years were 8.8%, 5.9% and 7.8% at the spine, femoral neck and trochanter, respectively.
Af patienter i behandling med alendronat oplevede 48% færre en eller flere vertebrale frakturer (alendronat 3, 2% versus placebo 6, 2%) sammenlignet med patienter behandlet med placebo.
There was a 48% reduction (alendronate 3.2% vs placebo 6.2%) in the proportion of patients treated with alendronate experiencing one or more vertebral fractures relative to those treated with placebo.
BMD i collum femoris og total- BMD blev opretholdt.
In the two-year extension of these studies BMD at the spine and trochanter continued to increase and BMD at the femoral neck and total body were maintained.
• FIT 1:
• FIT 1:
En 3- årig undersøgelse af 2. 027 patienter som havde mindst én vertebral (kompressions) fraktur ved baseline.
A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture.
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 vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%).
Derudover fandtes statistisk signifikant reduktion i incidensen af hoftefrakturer (1, 1% versus 2, 2%, en reduktion på 51%).
2.2%, a reduction of 51%).
En 4- årig undersøgelse af 4. 432 patienter med lav knoglemasse, men uden vertebral fraktur ved baseline.
A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture.
I denne undersøgelse observeredes en signifikant forskel i en analyse af subgruppen af osteoporotiske kvinder (37% af global population som havde osteoporose 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%).
8 5. 2 Farmakokinetiske egenskaber
Pharmacokinetic properties
Absorption I forhold til intravenøs referencedosis er den perorale biotilgængelighed for alendronat, når det administreres efter en nats faste og 2 timer før et standardiseret morgenmåltid, 0, 64% for kvinder ved doser fra 5- 70 mg.
Absorption Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast.
0, 46% og 0, 39%, når alendronat administreredes en time, eller en halv time, før et standardiseret morgenmåltid.
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.
Alendronatkomponenten i ADROVANCE (70 mg/ 2800 IE) kombinationstabletten er bioekvivalent til alendronat i 70 mg tabletten.
The alendronate component in the ADROVANCE (70 mg/ 2800 IU) combination tablet is bioequivalent to the alendronate 70 mg tablet.
60%.
Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.
Hos raske forsøgspersoner ændrer peroral prednison (20 mg, 3 gange dagligt i 5 dage) ikke alendronats perorale biotilgængelighed i signifikant grad (gennemsnitlig stigning fra 20- 44%).
In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20% to 44%).
Distribution Undersøgelser med rotter viser, at alendronat forbigående distribueres i blødt væv efter intravenøs administration af 1 mg/ kg, men herefter hurtigt redistribueres til knogler eller udskilles i urinen.
Distribution Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/ kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine.
Det gennemsnitlige steady- state fordelingsvolumen, ikke medregnende knogler, er mindst 28 liter hos mennesker.
The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans.
Koncentrationen af alendronat i plasma efter terapeutiske, orale doser er under analysegrænsen (< 5ng/ ml).
Concentrations of alendronate in plasma following therapeutic oral doses are too low for analytical detection (< 5 ng/ ml).
78%.
Protein binding in human plasma is approximately 78%.
50% af radioaktiviteten i urinen inden for 72 timer og kun lidt eller ingen radioaktivitet genfindes i fæces.
Elimination Following a single intravenous dose of [14C]alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces.
Efter en enkelt intravenøs dosis på 10 mg er renal clearance 71 ml/ minut, og systemisk clearance overstiger ikke 200 mg/ min.
Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/ min, and systemic clearance did not exceed 200 ml/ min.
Plasmakoncentrationen falder med mere end 95% inden for 6 timer efter intravenøs administration.
Plasma concentrations fell by more than 95% within six hours following intravenous administration.
Alendronat udskilles hos rotter ikke via nyrernes syre - eller basetransportsystem og forventes derfor ikke hos mennesker at interferere med andre lægemidlers udskillelse via disse systemer.
Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not anticipated to interfere with the excretion of other medicinal products by those systems in humans.
Colecalciferol
Colecalciferol
Absorption Ved administration af ADROVANCE 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 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.
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 5.9 ng/ ml, and the median time to maximal serum concentration (Tmax) was 12 hours.
Biotilgængeligheden for 2800 IE D3- vitamin i ADROVANCE er lig med 2800 IE D3- vitamin, administreret alene.
The bioavailability of the 2800 IU vitamin D3 in ADROVANCE is similar to 2800 IU vitamin D3 administered alone.
9 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.
D3- vitamin fordeles hurtigt til hovedsageligt leveren, hvor det metaboliseres til 25- hydroxyvitamin D3, den væsentligste oplagringsform.
Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form.
Mindre mængder distribueres til det adipøse væv og muskelvævet og oplagres som D3- vitamin på disse steder for senere frigivelse til kredsløbet.
9 these sites for later release into the circulation.
Cirkulerende D3- vitamin bindes til vitamin D- bindende protein.
Circulating vitamin D3 is bound to vitamin D-binding protein.
Biotransformation D3- vitamin metaboliseres hurtigt ved hydroxylering i leveren til 25- hydroxyvitamin D3 og metaboliseres efterfølgende i nyrerne til 1, 25- dihydroxyvitamin D3, som repræsenterer den biologisk aktive form.
Biotransformation Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1,25-dihydroxyvitamin D3, which represents the biologically active form.
For en lille procentdel af D3 - vitamin sker der en glucuronidisering før elimination.
A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.
Elimination Når radioaktivt D3- vitamin administreredes til raske forsøgspersoner, var den gennemsnitlige radioaktivitet i urinen efter 48 timer 2, 4%, og den gennemsnitlige radioaktivitet i fæces efter 4 dage var 4, 9%.
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%.
24 timer.
The mean half-life of vitamin D3 in the serum following an oral dose of ADROVANCE (70 mg/ 2800 IU) is approximately 24 hours.
Patientkarakteristika Prækliniske undersøgelser viser, at alendronat, der ikke deponeres i knoglen, hurtigt udskilles i urinen.
Characteristics in patients Preclinical studies show that alendronate that is not deposited in bone is rapidly excreted in the urine.
Der er ikke vist mætning af knogleoptagelsen efter kronisk dosering med kumulative, intravenøse doser på op til 35 mg/ kg hos dyr.
No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/ kg in animals.
Der foreligger ingen kliniske data herfor, men det er sandsynligt at eliminationen af alendronat via nyrerne, ligesom hos dyr, vil være reduceret hos patienter med nyreinsufficiens.
Although no clinical information is available, it is likely that, as in animals, elimination of alendronate via the kidney will be reduced in patients with impaired renal function.
4. 2).
Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).
Der er ikke udført non- kliniske studier med kombination af alendronat og colecalciferol.
Non-clinical studies with the combination of alendronate and colecalciferol have not been conducted.
Alendronat Non- kliniske data har ikke afsløret særlig risiko for mennesker, baseret på konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet ved gentagne doser, genotoksicitet og carcinogent potentiale.
Alendronate Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Colecalciferol Ved doser, der er meget højere end virkningsbredden for mennesker, er der observeret reproduktionstoksicitet i dyreundersøgelser.
Colecalciferol At doses far higher than the human therapeutic range, reproductive toxicity has been observed in animal studies.
Mikrokrystallinsk cellulose (E460) Vandfri laktose Triglycerider, middelkædelængde Gelatine Croscarmellosenatrium Saccharose Kolloid vandfri silica Magnesiumstearat (E572)
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)
6. 2 Uforligeligheder
10 6.2 Incompatibilities
6. 5 Emballage
6.5 Nature and contents of container
Forseglede aluminium/ aluminium blisterpakninger, i æsker med 2 (1 blisterpakning x 2 tabletter), 4 (1 blisterpakning x 4 tabletter), 6 (3 blisterpakninger x 2 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), 6 (3 wallets x 2 tablets), 12 (3 wallets x 4 tablets) or 40 (10 wallets x 4 tablets) tablets.
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