FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance of Rivastigmine 3M Health Care Ltd. is rivastigmine.
Slovenian: Zdravilna učinkovina v zdravilu Rivastigmin 3M Health Care Ltd. je rivastigmin.
English: - The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
Slovenian: - Obliž je treba z dlanjo čvrsto pritiskati na kožo najmanj 30 sekund, dokler se robovi dobro ne
English: Other medicines and Rivastigmine 3M Health Care Ltd.
Slovenian: Druga zdravila in zdravilo Rivastigmin 3M Health Care Ltd.
English: Very rare (may affect up to 1 in 10,000 people) - High blood pressure - Inflammation of the pancreas - the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting) - Bleeding in the gut - shows as blood in stools or when being sick - Seeing things that are not there (hallucinations) - Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)
Slovenian: - vnetje trebušne slinavke- med znaki so hude bolečine v zgornjem delu trebuha, pogosto skupaj z občutkom slabosti (navzeo) ali bruhanjem - krvavitev iz črevesja - kaže se kot kri v blatu ali pri bruhanju - vidna zaznava nečesa, česar v resnici ni tam (halucinacije) - pri nekaterih ljudeh je zaradi močnega bruhanja prišlo do raztrganja požiralnika (cevi, ki leži med usti in želodcem)
English: EXP
Slovenian: ADL
English: If you forget to use Rivastigmine 3M Health Care Ltd.
Slovenian: Če ste pozabili uporabiti zdravilo Rivastigmin 3M Health Care Ltd.
English: Hands should be washed with soap and water after removing the patch.
Slovenian: Po odstranjevanju obliža je treba roke umiti z milom in vodo.
English: No evidence of carcinogenicity was found in oral and topical studies in mice and in an oral study in rats at the maximum tolerated dose.
Slovenian: V raziskavah peroralnega in lokalnega odmerjanja na miših in raziskavah peroralnega odmerjanja na podganah pri največjem odmerku, ki so ga živali še prenašale, niso opazili nobenih znakov kancerogenosti.
English: Compared to a patient with a body weight of 65 kg, the rivastigmine steady-state concentrations in a patient with a body weight of 35 kg would be approximately doubled, while for a patient with a body weight of 100 kg the concentrations would be approximately halved.
Slovenian: V stanju dinamičnega ravnovesja so koncentracije pri bolniku s telesno maso 35 kg približno dvakrat tolikšne kot pri bolniku s telesno maso 65 kg, pri bolniku s telesno maso 100 kg pa pol manjše kot pri bolniku s telesno maso 65 kg. Zaradi vpliva telesne mase na izpostavljenost zdravilni učinkovini je potrebna posebna pozornost pri postopnem zviševanju odmerka bolnikom z zelo majhno telesno maso (glejte poglavje 4.4).
English: In case the adhesive residue is left over on your skin, gently soak the area with warm water and mild soap or use baby oil to remove it. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.
Slovenian: Če na koži ostane nekaj lepila, lepljivi predel kože navlažite s toplo raztopino blagega mila ali pa ostanke lepila odstranite z otroškim oljem.
English: Other side effects seen with Rivastigmine 3M Health Care Ltd. capsules or oral solution and which may occur with the patch:
Slovenian: Drugi neželeni učinki, ki so jih opažali pri uporabi kapsul ali peroralne raztopine Rivastigmin 3M Health Care Ltd. in bi se lahko pojavili tudi pri uporabi obližev:
English: The most commonly reported skin irritation events during the first 24 weeks of the double-blind period with rivastigmine 13.3 mg/24 h transdermal patches and rivastigmine 9.5 mg/24 h transdermal patches, respectively were application site erythema (5.7% vs 4.6%) and application site pruritus (3.6% vs 2.8%).
Slovenian: Najbolj pogoste oblike kožnih reakcij, o katerih so poročali v prvih 24 tednih dvojno slepega obdobja s transdermalnimi obliži z rivastigminom 13,3 mg/24 h in s transdermalnimi obliži z rivastigminom 9,5 mg/24 h, so bile rdečina na mestu aplikacije (5,7% v primerjavi s 4,6%) in srbenje na mestu aplikacije (3,6% v primerjavi z 2,8%).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLICA
English: - to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8) - to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because rivastigmine may cause increased gastric secretions (see section 4.8) - to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases.
Slovenian: atrioventrikularni blok) (glejte poglavje 4.8) - bolnikom z aktivnimi razjedami želodca ali dvanajstnika ali bolnikom z nagnjenostjo k tem boleznim, ker rivastigmin lahko povzroči povečano izločanje želodčne kisline (glejte
English: Skin application site reactions may occur with rivastigmine patch and are usually mild or moderate in intensity.
Slovenian: Pri uporabi transdermalnega obliža z rivastigminom lahko na koži pride do reakcij na mestu apliciranja, ki so običajno blago do zmerno izražene.
English: Consider using the 4.6 mg/24 h transdermal patch both as initial and maximum dose in these patients.
Slovenian: Pri teh bolnikih velja razmisliti o tem, da je začetni odmerek 4,6 mg/24 h za njih lahko tudi najvišji odmerek.
English: Uncommon (may affect up to 1 in 100 people) - Uneven heart rate (e.g. fast heart rate) - Difficulty sleeping - Accidental falls
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - neredno bitje srca (npr. hitro bitje srca)
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali z medicinsko sestro.
English: - A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to
Slovenian: - Bolnik, ki jemlje rivastigmin peroralno v odmerku 6 mg/dan, lahko preide na zdravljenje s
English: Hepatic impairment
Slovenian: Prebavne motnje
English: Overdose with rivastigmine transdermal patches resulting from misuse/dosing errors (application of multiple patches at a time) has been reported in the post-marketing setting.
Slovenian: V obdobju trženja zdravila so poročali o prevelikem odmerjanju s transdermalnimi obliži z rivastigminom, do česar je prišlo zaradi nepravilne uporabe/odmerjanja (nameščenih več obližev hkrati).
English: Marketing Authorisation Holder 3M Health Care Limited, 1 Morley Street,
Slovenian: 3M Health Care Limited, 1 Morley Street, Loughborough,
English: You should wash your hands with soap and water after removing the patch.
Slovenian: Po odstranjevanju obliža si morate roke umiti z milom in vodo.
English: Age had no impact on the exposure to rivastigmine in Alzheimer's disease patients treated with rivastigmine transdermal patches.
Slovenian: Pri bolnikih z Alzheimerjevo boleznijo, ki so jih zdravili s transdermalnimi obliži z rivastigminom, starost ni vplivala na izpostavljenost rivastigminu.
English: If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Slovenian: Na obliž lahko s tankim kemičnim svinčnikom napišete na primer
English: IMPORTANT: - Take off the previous patch before putting ONE new patch on. - Only one patch per day.
Slovenian: POMEMBNO: - Najprej odstranite prejšnji obliž in šele nato namestite EN nov obliž.
English: Dose escalation
Slovenian: Zviševanje odmerka
English: How to apply your Rivastigmine 3M Health Care Ltd. transdermal patch Rivastigmine 3M Health Care Ltd. patches are transparent to translucent, plastic patches that stick to the skin.
Slovenian: Obliži Rivastigmin 3M Health Care Ltd. so prozorni ali prosojni plastični obliži, ki jih prilepite na kožo.
English: Package Leaflet: Information for the user Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Slovenian: Navodilo za uporabo Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž rivastigmin
English: PHARMACEUTICAL FORM
Slovenian: IME ZDRAVILA
English: • Take off the previous patch before putting ONE new patch on.
Slovenian: • Najprej odstranite prejšnji obliž in šele nato namestite EN nov obliž.
English: No specific interaction studies have been performed with Rivastigmine 3M Health Care Ltd. transdermal patches.
Slovenian: S transdermalnimi obliži Rivastigmin 3M Health Care Ltd. niso izvedli specifičnih študij medsebojnega delovanja.
English: No study was conducted with rivastigmine transdermal patches in subjects with renal impairment.
Slovenian: Pri osebah z okvaro ledvic niso opravili nobene študije s transdermalnimi obliži z rivastigminom.
English: - to patients with a history of asthma or obstructive pulmonary disease.
Slovenian: - bolnikom, ki so nagnjeni k zapori sečnih izvodil in k epileptičnim napadom, ker holinomimetiki lahko sprožijo te bolezni ali njihovo poslabšanje - bolnikom z anamnezo astme ali obstruktivne pljučne bolezni.
English: Unchanged rivastigmine is found in trace amounts in the urine; renal excretion of the metabolites is the major route of elimination after transdermal patch administration.
Slovenian: Nespremenjeni rivastigmin najdemo v urinu samo v sledovih.
English: After a minimum of four weeks of treatment and if well tolerated according to the treating physician, the dose of 4.6 mg/24 h should be increased to 9.5 mg/24 h, the daily recommended effective dose, which should be continued for as long as the patient continues to demonstrate therapeutic benefit.
Slovenian: Če bolnik ta odmerek po presoji lečečega zdravnika dobro prenaša, je treba po najmanj štirih tednih odmerek 4,6 mg/24 h zvišati na 9,5 mg/24 h, kar je priporočeni dnevni učinkoviti odmerek.
English: Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
Slovenian: Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž rivastigmin
English: Urinary tract infection Metabolism and nutrition disorders Common
Slovenian: - urinska inkontinenca (nezmožnost zadrževanja urina)
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and oral rivastigmine.
Slovenian: Pri sočasni uporabi digoksina in peroralnega rivastigmina niso opazili neželenih učinkov na srčno prevodnost.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h
Slovenian: Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h
English: How to store Rivastigmine 3M Health Care Ltd.
Slovenian: Kako jemati zdravilo Rivastigmin 3M Health Care Ltd.
English: The percentages decreased in both rivastigmine 13.3 mg/24 h transdermal patch and rivastigmine 9.5 mg/24 h transdermal patch treatment groups over time (>24 weeks): application site erythema (0.8% vs. 1.6%) and application site pruritus (0.4% vs. 1.2%), respectively.
Slovenian: Odstotek bolnikov z navedenimi težavami se je sčasoma ( po več kot 24-tedenski uporabi) znižal tako v skupini, v kateri so uporabljali transdermalni obliž z rivastigminom 13,3 mg/24 h, kot tudi v skupini, v kateri so uporabljali transdermalni obliž z rivastigminom 9,5 mg/24 h: rdečina na mestu aplikacije (0,8 % v primerjavi z 1,6 %) in srbenje na mestu aplikacije (0,4 % v primerjavi z 1,2 %).
English: • Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Slovenian: • Obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund.
English: Rivastigmine 3M Health Care Ltd. is used for the treatment of adult patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Slovenian: Zdravilo Rivastigmin 3M Health Care Ltd. uporabljamo za zdravljenje odraslih bolnikov z blago do zmerno hudo Alzheimerjevo demenco.
English: - Do not cut the patch into pieces.
Slovenian: - Samo en obliž na dan. - Obliža ne smete rezati na manjše dele.
English: Rivastigmine 9.5 mg/24 h
Slovenian: Rivastigm in 9,5 mg/24 h n povpre čje
English: Aggression
Slovenian: Rivastigmin
English: You should not breast-feed during treatment with Rivastigmine 3M Health Care Ltd. transdermal patches.
Slovenian: Med zdravljenjem s transdermalnimi obliži Rivastigmin 3M Health Care Ltd. ne smete dojiti.
English: NAP226-90) and bodyweight was observed in Alzheimer's dementia patients.
Slovenian: Pri bolnikih z Alzheimerjevo demenco so opazovali razmerje med telesno maso in izpostavljenostjo zdravilni učinkovini (rivastigminu in presnovku NAP226-90) v stanju dinamičnega ravnovesja.
English: No study was conducted with rivastigmine transdermal patches in subjects with hepatic impairment.
Slovenian: Pri osebah z okvaro jeter niso opravili nobene študije s transdermalnimi obliži z rivastigminom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž
English: - Treatment usually starts with Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h. - The recommended daily dose is Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h (this high strength is currently not available from 3M but may be available from other Marketing
Slovenian: - Zdravljenje se običajno začne z obližem Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h. - Priporočeni običajni dnevni odmerek zdravila Rivastigmin 3M Health Care Ltd. je 9,5 mg/24 h.
English: INFORMATION IN BRAILLE Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h
Slovenian: Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h
English: Application site skin reactions (e.g. application site erythema, application site pruritus, application site oedema, application site dermatitis, application site irritation), asthenic conditions (e.g. fatigue,
Slovenian: Bolezni sečil pogosti urinska inkontinenca Splošne težave in spremembe na mestu aplikacije pogosti kožne reakcije na mestu aplikacije (npr. rdečina na mestu aplikacije, srbenje na mestu aplikacije, oteklina na mestu aplikacije, dermatitis na mestu aplikacije, draženje na mestu aplikacije), astenična stanja (npr. utrujenost, astenija), zvišana telesna temperatura, zmanjšanje telesne mase redki padec
English: ADAS-cog scores: A negative difference in DLSM indicates greater improvement in Rivastigmine 13.3 mg/24 h as compared to Rivastigmine 9.5 mg/24 h.
Slovenian: DLSM - razlika po metodi najmanjših kvadratov (angl. difference in least square means) LOCF - metoda prenosa zadnje ocene naprej (angl. Last Observation Carried Forward) ocene pri lestvici ADAS-cog: negativna vrednost razlike po metodi najmanjših kvadratov pomeni večje izboljšanje pri uporabi obliža Rivastigmin 13,3 mg/24 h kot pri uporabi obliža Rivastigmin 9,5 mg/24 h. ocene pri lestvici ADCS-IADL: pozitivna vrednost razlike po metodi najmanjših kvadratov pomeni večje izboljšanje pri uporabi obliža Rivastigmin 13,3 mg/24 h kot pri uporabi obliža Rivastigmin 9,5 mg/24 h.
English: Only one patch should be worn at a time (see section 4.9).
Slovenian: Nameščen sme biti samo en obliž naenkrat (glejte
English: - Press the patch firmly in place for at least 30 seconds using the palm of the hand.
Slovenian: - Obliž z dlanjo čvrsto pritiskajte na kožo najmanj 30 sekund.
English: The patient's weight should be monitored during therapy with Rivastigmine 3M Health Care Ltd. transdermal patches.
Slovenian: Med zdravljenjem s transdermalnimi obliži Rivastigmin 3M Health Care Ltd. je treba spremljati bolnikovo telesno maso.
English: Skin application site reactions
Slovenian: Večina kožnih reakcij je bila omejena na mesto aplikacije.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 9.5 mg/24 h transdermal patch rivastigmine
Slovenian: IME ZDRAVILA Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni obliž
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h transdermal patch rivastigmine
Slovenian: IME ZDRAVILA Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni obliž
English: Rivastigmine 13.3 mg/24 h N = 265
Slovenian: Rivastigmin transdermalni obliži 9,5 mg/24 h N = 251
English: BATCH NUMBER
Slovenian: vrednost p
English: How to use Rivastigmine 3M Health Care Ltd.
Slovenian: Kako odstraniti transdermalni obliž Rivastigmin 3M Health Care Ltd.
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Imetnik dovoljenja za promet z zdravilom
English: The backing layer is transparent to translucent, labelled with “R10” in a repeated pattern.
Slovenian: Krovna plast je prozorna do prosojna in označena z oznako
English: PHARMACEUTICAL PARTICULARS
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:
Slovenian: Če opazite katerega od naslednjih neželenih učinkov, ki bi lahko postali resni, takoj snemite
English: Carefully remove the existing patch before putting on a new one.
Slovenian: Previdno odstranite obliž, ki je že na koži, in šele potem
English: - Carefully remove any existing patch before putting on a new one.
Slovenian: - Preden namestite nov obliž, previdno odstranite prešnjega.
English: 4.6 mg
Slovenian: vrednost p a
English: Take off your patch and tell your doctor straight away, if you notice any of the side effects above.
Slovenian: Če opazite katerega od zgoraj navedenih neželenih učinkov, takoj snemite obliž in obvestite svojega
English: Otherwise your doctor will restart your treatment on Rivastigmine 3M Health Care Ltd. 4.6 mg/24 h.
Slovenian: Če zdravljenja s transdermalnim obližem niste prekinili za več kot tri dni, lahko nadaljujete z enakim odmerkom, v nasprotnem primeru pa vam bo zdravnik ponovno uvedel zdravilo Rivastigmin 3M Health Care Ltd. v odmerku 4,6 mg/24 h.
English: This summary was last updated in 04-2016.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva on 23 February 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Bonviva, veljavno po vsej Evropski uniji, izdala 23. februarja 2004.
English: What measures are being taken to ensure the safe and effective use of Bonviva?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bonviva?
English: (In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used.)
Slovenian: (Na območjih s trdo vodo, kjer voda iz pipe vsebuje veliko raztopljenega kalcija, se lahko uporabi ustekleničena voda z nizko vsebnostjo mineralov).
English: The full EPAR for Bonviva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bonviva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Bonviva
Slovenian: Druge informacije o zdravilu Bonviva
English: Gradually, the bones become thin and fragile, and more likely to break.
Slovenian: Kosti se tako postopoma redčijo in postajajo krhkejše ter posledično bolj lomljive.
English: Blocking the action of these cells leads to less bone loss.
Slovenian: Zaviranje delovanja teh celic povzroči manjšo izgubo kostne mase.
English: Bonviva has been studied in three main studies involving women with osteoporosis.
Slovenian: Zdravilo Bonviva so raziskovali v treh glavnih študijah, v katere so bile vključene ženske z osteoporozo.
English: This is a summary of the European public assessment report (EPAR) for Bonviva.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bonviva.
English: Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
Slovenian: Bolnice, ki jemljejo zdravilo Bonviva, bi morale jemati tudi dodatke vitamina D in kalcija, če teh ne dobivajo v zadostni količini s prehrano.
English: What benefit has Bonviva shown during the studies?
Slovenian: Kakšne koristi je zdravilo Bonviva izkazalo med študijami?
English: For more information about treatment with Bonviva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Bonviva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The tablets must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit upright for at least an hour.
Slovenian: Tablet ne smejo jemati bolnice z nepravilnostmi v požiralniku ali bolnice, ki ne morejo stati ali sedeti vzravnano vsaj eno uro.
English: Bonviva ibandronic acid
Slovenian: Bonviva ibandronska kislina
English: The most serious side effects with Bonviva are anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut) irritation and eye inflammation.
Slovenian: Najresnejši neželeni učinki zdravila Bonviva so anafilaktične reakcije (hude alergijske reakcije), neznačilni zlomi stegnenice (neobičajne vrste zloma kosti v stegnu), osteonekroza čeljusti (poškodba čeljustne kosti, ki lahko povzroči bolečine, oteklost v ustih in majanje zob), gastrointestinalno razdraženost (razdražen želodec in črevesje) ter vnetje oči.
English: If the tablet is used, the dose is one tablet every month, preferably on the same date each month.
Slovenian: Pri uporabi tablet je odmerek ena tableta na mesec, zaželeno na isti dan v mesecu.
English: A risk management plan has been developed to ensure that Bonviva is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Bonviva je bil pripravljen načrt obvladovanja tveganj.
English: The 2.5-mg once-daily tablets used in the studies are no longer authorised.
Slovenian: V študiji uporabljene 2,5-miligramske tablete, ki se jemljejo enkrat na dan, niso več odobrene.
English: The dose by injection is 3 mg once every three months.
Slovenian: V primeru injiciranja se daje en 3-miligramski odmerek vsake tri mesece.
English: The CHMP decided that Bonviva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Bonviva večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
Slovenian: Učinek zdravila pri zmanjševanju tveganja za zlome hrbtenice je bil dokazan v študijah, medtem ko njegov učinek na tveganje za zlom stegneničnega vratu (zgornjega dela stegnenice) ni bil dokazan.
English: It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Slovenian: Zavira dejavnost osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
English: The studies looked at the change in the density of the bones in the spine and the hip over two years.
Slovenian: V študijah so primerjali spremembo gostote kosti v hrbtenici in kolkih v dveletnem obdobju.
English: It is available as tablets (150 mg) and as a solution for injection in a prefilled syringe (3 mg).
Slovenian: Na voljo je v obliki tablet (150 mg) in raztopine za injiciranje v napolnjeni injekcijski brizgi (3 mg).