natgillin/translations-raw huggingface dataset:
24 Hepatic impairment Following multiple doses of 80 mg of ADENURIC in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, the Cmax and AUC of febuxostat and its metabolites did not change significantly compared to subjects with normal hepatic function.
Okvarjeno delovanje jeter Pri ponavljajočih se odmerkih zdravila ADENURIC 80 mg pri bolnikih z blago (razred A po Child - Pughu) ali zmerno (razred B po Child- Pughu) okvaro jeter se Cmax in AUC febuksostata in njegovih presnovkov nista pomembneje spremenili v primerjavi z osebami z normalnim delovanjem jeter.
Carcinogenesis, mutagenesis, impairment of fertility In male rats, a statistically significant increase in urinary bladder tumours (transitional cell papilloma and carcinoma) was found only in association with xanthine calculi in the high dose group, at approximately 11 times human exposure.
Karcinogeneza, mutageneza, škodljivo delovanje na plodnost Pri podganjih samcih so opazili statistično pomembno večjo pojavnost tumorjev sečnega mehurja (prehodnocelični papilom in karcinom) samo v povezavi s ksantinskimi kamni pri skupini, ki je bila izpostavljena visokim odmerkom, približno 11- kratni izpostavljenosti človeka.
Tablet core Lactose monohydrate Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose 25 Croscarmellose sodium Silica, colloidal hydrated
Jedro tablete laktoza monohidrat mikrokristalna celuloza magnezijev stearat hidroksipropilceluloza premreženi natrijev karmelozat koloidni hidratirani silicijev dioksid
ADENURIC 120 mg is available in pack sizes of 28 and 84 film-coated tablets.
Zdravilo ADENURIC 120 mg je na voljo v škatlah po 28 in 84 filmsko obloženih tablet.
27 ANNEX II
25 DODATEK II
AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Patheon France 40 Boulevard de Champaret FR-38300 Bourgoin Jallieu France
Patheon France 40 Boulevard de Champaret FR- 38300 Bourgoin Jallieu Francija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 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. 0, 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.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 (19 February 2008) 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 2. 0 (19 Februar 2008) Načrta za obvladovanje tveganja predstavljenega v Modulu 1. 8. 2. vloge ter naknadnih dopolnil Načrta za obvladovanje 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 za obvladovanje tveganja v skladu s Smernicami za sisteme obvladovanja 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 za obvladovanje 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 (EMEA).
29 ANNEX III
27 DODATEK III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
29 PODATKI NA ZUNANJI OVOJNINI ŠKATLA
BATCH NUMBER Lot:
ŠTEVILKA SERIJE
33 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
31 PODATKI NA ZUNANJI OVOJNINI ŠKATLA
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
BATCH NUMBER Lot
ŠTEVILKA SERIJE
Mon Tue Wed Thurs Fri Sat Sun
Pon Tor Sre Čet Pet Sob Ned
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
34 PODATKI NA ZUNANJI OVOJNINI ŠKATLA
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
36 PODATKI NA ZUNANJI OVOJNINI ŠKATLA
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
INFORMATION FOR THE USER
40 NAVODILO ZA UPORABO
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What ADENURIC is and what it is used for 2.
Kaj je zdravilo ADENURIC in za kaj ga uporabljamo 2.
Before you take ADENURIC 3.
Kaj morate vedeti, preden boste vzeli zdravilo ADENURIC 3.
How to take ADENURIC 4.
Kako jemati zdravilo ADENURIC 4.
Possible side effects 5 How to store ADENURIC 6.
Možni neželeni učinki 5 Shranjevanje zdravila ADENURIC 6.
WHAT ADENURIC IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ADENURIC IN ZA KAJ GA UPORABLJAMO
ADENURIC tablets are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body.
Tablete ADENURIC uporabljamo za zdravljenje protina, ki je povezan z izločanjem substance, ki se imenuje sečna kislina (urati) v telesu.
Left untreated, larger deposits called tophi (TOE-FI) may form in and around joints.
Nezdravljeni izbruhi protina lahko povzročijo odlaganje večjih depozitov uratov v sklepih in okoli njih, ki se imenujejo tofi.
BEFORE YOU TAKE ADENURIC
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ADENURIC
Do not take ADENURIC if you are: • If you are allergic (hypersensitive) to febuxostat, the active ingredient of ADENURIC, or any of the other ingredients in these tablets.
Ne jemljite zdravila ADENURIC: • če ste alergični na (preobčutljivi za) febuksostat, zdravilno učinkovino zdravila ADENURIC, ali katerokoli sestavino tablet.
Take special care with ADENURIC Tell your doctor before you start to take this medicine: • If you have or have had heart failure or heart problems • If you are being treated for high uric acid levels as a result of cancer disease or Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood) • If you have thyroid problems
Bodite posebno pozorni pri jemanju zdravila ADENURIC Obvestite svojega zdravnika, preden začnete jemati to zdravilo: • če imate ali ste imeli srčno popuščanje ali težave s srcem, • če se zdravite zaradi visokih ravni sečne kisline, ki so posledica rakavega obolenja ali Lesch - Nyhanovega sindroma (redka dedna bolezen, pri kateri je v krvi preveč sečne kisline), • če imate težave s ščitnico.
43 For some people, gout attacks may flare up when starting certain medicines that control uric acid levels.
41 Pri nekaterih ljudeh se izbruh protina lahko pojavi, ko začnejo jemati nekatera zdravila, ki nadzirajo ravni sečne kisline.
Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day.
Čez čas se izbruhi protina pojavljajo manj pogosto in so manj boleči, če z jemanjem zdravila ADENURIC nadaljujete vsak dan.
Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with ADENURIC and your doctor may wish to consider necessary measures: • Mercaptopurine (used to treat cancer) • Azathioprine (used to reduce immune response) • Theophylline (used to treat asthma) • Warfarin (used to thin your blood if you have a heart condition)
Zlasti pomembno je, da zdravnika ali farmacevta obvestite, če jemljete zdravila, ki vsebujejo katero od naslednjih učinkovin, da bo vaš zdravnik ocenil, ali so potrebni ustrezni ukrepi, saj lahko pride do medsebojnega delovanja z zdravilom ADENURIC: • merkaptopurin (uporablja se za zdravljenje raka), • azatioprin (uporablja se za zaviranje imunskega odziva), • teofilin (uporablja se za zdravljenje astme), • varfarin (uporablja se za preprečevanje strjevanja krvi, če imate bolezen srca).
Taking ADENURIC with food and drink The tablets should be taken by mouth and can be taken with or without food.
Lahko jih jemljete s hrano ali brez nje.
Pregnancy and breast-feeding It is not known if ADENURIC may harm your unborn child.
Nosečnost in dojenje Ni znano, ali zdravilo ADENURIC škodljivo vpliva na nerojenega otroka.
Tell your doctor if you think you are pregnant or if you are planning to become pregnant as ADENURIC should not be used during pregnancy.
Zdravnika obvestite, če mislite, da ste noseči ali nameravate zanositi, saj zdravila ADENURIC med nosečnostjo ne smete jemati.
Driving and using machines No studies on the effects of ADENURIC on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študij o vplivu zdravila ADENURIC na sposobnost vožnje in upravljanja s stroji niso izvedli.
However, you should be aware that you may experience dizziness, sleepiness and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
Če se pojavi karkoli od navedenega, ne smete voziti ali upravljati s stroji.
Important information about some of the ingredients of ADENURIC ADENURIC tablets contain lactose (a type of sugar).
Pomembne informacije o nekaterih sestavinah zdravila ADENURIC Zdravilo ADENURIC vsebuje laktozo (vrsto sladkorja).
If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
HOW TO TAKE ADENURIC
KAKO JEMATI ZDRAVILO ADENURIC
Always take ADENURIC exactly as your doctor has told you.
Pri jemanju zdravila ADENURIC natančno upoštevajte zdravnikova navodila.
• The usual dose is one tablet daily.
Običajni odmerek je ena tableta na dan.
The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day. • The tablets should be taken by mouth and can be taken with or without food.
Na hrbtni strani pretisnega omota so oznake dni v tednu, s pomočjo katerih lahko nadzirate jemanje svojega odmerka vsak dan.
It is important that you do not stop taking ADENURIC unless your doctor tells you to.
Pomembno je, da ne prenehate jemati zdravila ADENURIC, razen če se tako odloči vaš zdravnik.
Continue to take ADENURIC every day even when you are not experiencing gout flare or attack.
42 Z jemanjem zdravila ADENURIC nadaljujte vsak dan, tudi ko pri vas ne pride do izbruha ali poslabšanja protina.
44 If you take more ADENURIC than you should In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
Če ste vzeli večji odmerek zdravila ADENURIC, kot bi smeli V primeru nezgodnega prevelikega odmerka se o tem, kaj morate storiti, posvetujte s svojim zdravnikom ali pojdite v najbližji urgentni oddelek za nezgode in nujne primere.
If you forget to take ADENURIC If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
V tem primeru pozabljeni odmerek izpustite in vzemite naslednji odmerek ob običajnem času.
If you stop taking ADENURIC Do not stop taking ADENURIC without the advice of your doctor even if you feel better.
Če ste prenehali jemati zdravilo ADENURIC Brez nasveta zdravnika ne prenehajte jemati zdravila ADENURIC, tudi če se počutite bolje.
Like all medicines, ADENURIC can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ADENURIC neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Common side effects (more than 1 in 100 patients but less than 1 in 10 patients) are: • abnormal liver test results • diarrhoea • headache • rashes • feeling sick
Pogosti neželeni učinki (pojavijo se pri več kot 1 od 100 bolnikov, vendar manj kot pri 1 od 10) so: • nenormalni izvidi testov delovanja jeter, • driska, • glavobol, • izpuščaj, • siljenje na bruhanje.
Uncommon side effects (more than 1 in 1,000 patients but less than 1 in 100 patients) are: • weight gain, increased appetite, change in blood sugar levels (diabetes) of which a symptom may be excessive thirst, increased blood fat levels • erectile difficulties and/ or loss of sex drive • difficulty in sleeping • dizziness, numbness or tingling sensation, sleepiness, impaired sense of taste, reduction in sensation of touch • abnormal ECG heart tracing • hot flushes or blushing (e. g. redness of the face or neck), increased blood pressure • cough, shortness of breath, flu-like symptoms • dry mouth, abdominal pain/ discomfort or wind, heartburn/ indigestion, constipation, more frequent passing of stools • vomiting • itching, hives, skin inflammation or discolouration, other type of skin conditions • muscle cramp, pain/ ache in muscles/ joints, bursitis or arthritis (inflammation of joints usually accompanied by pain, swelling and/ or stiffness) • blood in the urine, abnormal frequent urination, kidney stones, abnormal urine tests (increased level of proteins in urine), a reduction in the ability of the kidneys to function properly • fatigue, localised swelling due to the retention of fluids in the tissues (oedema) • changes in blood chemistry or amount of blood cells (abnormal blood test results)
Občasni neželeni učinki (pojavijo se pri več kot 1 od 1. 000 bolnikov, vendar manj kot pri 1 od 100) so: • povišanje telesne mase, povečan apetit, spremembe ravni sladkorja v krvi (sladkorna bolezen), katerih simptom je huda žeja, povišane ravni maščob v krvi, • težave z erekcijo ali izguba spolne sle, • težave s spanjem, • omotičnost, občutek odrevenelosti ali ščemenja, zaspanost, okvara čuta za okušanje, zmanjšana občutljivost za dotik, • nenormalnosti izvidov EKG, • vročični navali ali zardevanje (npr. pordelost obraza ali vratu), zvišan krvni tlak, • kašelj, težko dihanje, gripi podobni simptomi, • suha usta, bolečine/ nelagodje v trebuhu ali napenjanje, zgaga/ slaba prebava, zaprtost, pogostejše izločanje blata, • bruhanje, • srbenje, izpuščaj, vnetje ali sprememba barve kože, druge vrste kožnih težav, • mišični krči, bolečine v mišicah ali sklepih, burzitis ali artritis (vnetje sklepov, ki ga običajno spremlja bolečina, oteklost ali otrdelost), • kri v urinu, nenormalno pogosto uriniranje, ledvični kamni, nenormalni rezultati testov urina (povišana raven beljakovin v urinu), oslabljeno delovanje ledvic, • utrujenost, lokalizirana oteklina zaradi zastajanja tekočine v tkivu (edem), • spremembe v krvni sliki ali v številu krvnih celic (nenormalni rezultati krvnih preiskav).
Rare side effects (more than 1 in 10,000 patients but less than 1 in 1,000 patients) are: • weakness • nervousness • feeling thirsty • feeling your heartbeat
43 Redki neželeni učinki (pojavijo se pri več kot 1 od 10. 000 bolnikov, vendar manj kot pri 1 od 1. 000) so: • oslabelost, • živčnost, • žeja, • neprijetni občutek ob hitrem ali močnem utripanju srca.
45 If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE ADENURIC
SHRANJEVANJE ZDRAVILA ADENURIC
• Keep out of the reach and sight of children. • Do not use after the expiry date which is stated on the carton and the tablet blister foil after ‘ EXP .’ The expiry date refers to the last day of that month. • This medicinal product does not require any special storage conditions.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
What ADENURIC contains
Kaj vsebuje zdravilo ADENURIC
Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172)
Opadry II rumena 85F42129, ki vsebuje: polivinil alkohol, titanov dioksid (E171), makrogol 3350, smukec, rumeni železov oksid (E172).
The 80 mg film-coated tablets are marked on one side with ‘ 80’.
80 mg filmsko obložene tablete imajo na eni strani vtisnjeno oznako ‘ 80 ’.
The 120 mg film-coated tablets are marked on one side with ‘ 120’.
120 mg filmsko obložene tablete imajo na eni strani vtisnjeno oznako ‘ 120 ’.
ADENURIC is supplied in 2 blisters of 14 tablets (28 tablet pack), or 6 blisters of 14 tablets (84 tablet pack).
Zdravilo ADENURIC je na voljo v 2 pretisnih omotih po 14 tablet (pakiranje z 28 tabletami) ali 6 pretisnih omotih po 14 tablet (pakiranje s 84 tabletami).
Marketing Authorisation Holder Beaufour Ipsen Pharma 24 rue Erlanger 75781 Paris Cedex 16 France
Imetnik dovoljenja za promet z zdravilom Beaufour Ipsen Pharma 24 rue Erlanger 75781 Paris Cedex 16 Francija
Manufacturer Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu France
44 40 boulevard de Champaret 38300 Bourgoin Jallieu Francija
46 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
България Beaufour Ipsen Pharma 24 rue Erlanger F-75781 Paris Cedex 16 France Tél: + 33 - 1 - 44 96 13 13
България Beaufour Ipsen Pharma 24 rue Erlanger F- 75781 Paris Cedex 16 Francija Tél: + 33 - 1 - 44 96 13 13
Eesti ESTOBIIN OÜ Udeselja 4-4 11913 Tallinn Tel: +372 51 55810
Eesti ESTOBIIN OÜ Udeselja 4- 4
Δημητρίου 63 Άλιμος GR-17456 Αθήνα / Athens ΕΛΛΑΔΑ / GREECE Τηλ / Tel: + 30 - 210 - 984 3324
Δημητρίου 63 Άλιμος GR- 17456 Αθήνα/ Athens ΕΛΛΆΔΑ/ GREECE
Slovenija Pharmaswiss d. o. o Dolenjska cesta 242c SI-1000 Ljubljana Tel: + 386 1 236 47 00
Dolenjska cesta 242c SI- 1000 Ljubljana Tel: + 386 1 236 47 00
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
What is ADROVANCE?
Kaj je zdravilo ADROVANCE?
ADROVANCE is a white capsule-shaped tablet containing two active substances: alendronate sodium trihydrate (70 mg) and colecalciferol (vitamin D3, 70 micrograms equivalent to 2,800 international units).
Zdravilo ADROVANCE so bele tablete v obliki kapsule, ki vsebujejo dve zdravilni učinkovini: natrijev alendronat trihidrat (70 mg) in holekalciferol (vitamin D3, 70 mikrogramov, kar ustreza 2. 800 mednarodnim enotam – i. e.).
This medicine is the same as FOSAVANCE, which is already authorised in the European Union.
Gre za enako zdravilo kot je zdravilo FOSAVANCE, ki je že odobreno v Evropski uniji.
The company that makes FOSAVANCE has agreed that its scientific data can be used for ADROVANCE.
Podjetje, ki proizvaja zdravilo FOSAVANCE se strinja, da se lahko znanstveni podatki zdravila uporabijo za zdravilo ADROVANCE.
What is ADROVANCE used for?
Za kaj se zdravilo ADROVANCE uporablja?
ADROVANCE is used to treat osteoporosis (a disease that makes bones fragile) in post-menopausal women at risk of low vitamin D levels.
Zdravilo ADROVANCE se uporablja za zdravljenje osteoporoze (bolezni, zaradi katere postanejo kosti krhke) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D.
ADROVANCE reduces the risk of vertebral (spine) and hip fractures (breaks).
Zdravilo ADROVANCE zmanjšuje tveganje za vertebralne zlome (hrbtenice) in zlome kolka.
How is ADROVANCE used?
Kako se zdravilo ADROVANCE uporablja?
The recommended dose is one tablet once a week.
Priporočeni odmerek je ena tableta enkrat tedensko.
ADROVANCE is intended for long-term use.
Zdravilo ADROVANCE je namenjeno za dolgotrajno uporabo.
The patient must take the tablet with a full glass of water (not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Bolnik mora zaužiti tableto s polnim kozarcem vode (ne mineralne vode), in sicer najmanj 30 minut pred zaužitjem hrane, pijače ali drugih zdravil (vključno z antacidi, dodatki kalcija in vitamini).
To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Da bi preprečili draženje požiralnika, bolnik ne sme leči, dokler ne zaužije prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
The tablet should not be chewed or allowed to dissolve in the mouth.
Bolnik tablete ne sme žvečiti ali je raztopiti v ustih.
Patients should also take calcium supplements if they are not getting enough calcium from their diet.
Bolniki morajo jemati tudi nadomestni kalcij, če vnos le- tega s prehrano ni zadosten.
For more information, see the Package Leaflet.
Več informacij najdete v Navodilih za uporabo.
How does ADROVANCE work?
Kako zdravilo ADROVANCE deluje?
Bone is a living tissue that is constantly renewed by a process that erodes old bone and replaces it with new bone at the same rate.
Kost je živo tkivo, ki se neprestano obnavlja na podlagi procesa, ki razgrajuje staro kostno maso in jo v enaki meri nadomešča z novo.
Osteoporosis is a disease in which the bones gradually become thin and fragile, and more likely to break (fracture).
Osteoporoza je bolezen, zaradi katere postanejo kosti postopoma tanke in krhke ter posledično bolj lomljive.
It happens when not enough new bone grows to replace the bone that is naturally broken down.
Do osteoporoze pride, ko se ne tvori več dovolj nove kostne mase, da bi nadomestila naravno razgradnjo kosti.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.
Osteoporoza je pogostejša pri ženskah po menopavzi, ko raven ženskega hormona estrogena pade, saj estrogen prispeva k ohranjanju zdravih kosti.
The active substances in ADROVANCE are alendronate and vitamin D3.
Zdravilni učinkovini zdravila ADROVANCE sta alendronat in vitamin D3.
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Alendronat je difosfonat, ki se pri zdravljenju osteoporoze uporablja od sredine devetdesetih let.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Ustavi delovanje osteoklastov, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Z zaviranjem delovanja teh celic alendronat privede do manjše izgube kostne mase.