FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission issued a legally binding decision to suspend the marketing authorisation on 8 March 2018.
Estonian: 8. märtsil 2018 avaldas Euroopa Komisjon õiguslikult siduva otsuse müügiloa peatamise kohta.
English: The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.
Estonian: Seetõttu kinnitas ravimiohutuse riskihindamise komitee oma varasemaid järeldusi, et Zinbryta riskid on hulgiskleroosiga patsientidel suuremad kui ravimi kasulikkus.
English: On 6 March 2018, while the review was ongoing, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspension of the marketing authorisation of Zinbryta and a recall of the
Estonian: 6. märtsil 2018, kui läbivaatamine veel kestis, soovitas EMA ravimiohutuse riskihindamise komitee peatada Zinbryta müügiloa ja võtta ravim turult tagasi.
English: The PRAC has now concluded its review of the available evidence on Zinbryta.
Estonian: Nüüdseks on ravimiohutuse riskihindamise komitee Zinbryta kohta kättesaadava tõendusmaterjali läbivaatamise lõpetanud.
English: On 27 March 2018, the European Commission withdrew the marketing authorisation of the medicine at the request of the marketing authorisation holder Biogen Idec Ltd.
Estonian: 27. märtsil 2018 tühistas Euroopa Komisjon müügiloa hoidja Biogen Idec Ltd taotlusel ravimi müügiloa.
English: On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.
Estonian: 27. märtsil 2018 tühistati ravimi müügiluba turustaja Biogen Idec Ltd taotlusel.
English: 0.5 mL (0.5 mg/mL) 1 pre-filled syringe
Estonian: EU/1/00/130/001 Orgalutran 0.25 mg/0,5 ml Süstelahus injection
English: This summary was last updated in 03-2011.
Estonian: Kokkuvõtte viimane uuendus: 03-2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Valtropin to BioPartners GmbH on 24 April 2006.
Estonian: Euroopa Komisjon andis Valtropini müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele BioPartners GmbH 24. aprillil 2006.
English: The full EPAR for Valtropin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Valtropini kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Valtropin was compared with Humatrope in 149 children with a lack of growth hormone and who had not been treated before.
Estonian: Valtropini võrreldi Humatropega 149 lapsel, kellel oli kasvuhormooni puudulikkus ja keda ei olnud varem ravitud.
English: Valtropin is used to treat children in the following situations:
Estonian: Valtropini kasutatakse laste raviks järgmistes olukordades:
English: After 12 months, treatment with Valtropin and Humatrope brought about similar increases in height and speed of growth (speed of +11.4 and +10.5 cm per year, respectively).
Estonian: 12-kuulise ravi järel saavutati Valtropini ja Humatropega sarnane kasvuiive ja -kiirus (kiirus vastavalt 11,4 cm ja 10,5 cm aastas).
English: The study lasted 12 months, and measured the children's height at the beginning and the end of the study, and the speed of growth during the study.
Estonian: Uuring kestis 12 kuud ja selle alguses ja lõpus uuriti laste kasvu ja uuringuaegset kasvukiirust.
English: Therefore, the CHMP's view was that, as for Humatrope, the benefit outweighs the identified risks.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Humatrope korral, ületab ravimi kasulikkus tuvastatud riskid.
English: This means that Valtropin is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Valtropin and the reference medicine contain the same active substance.
Estonian: See tähendab, et Valtropin on sarnane bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba ning mis sisaldab sama toimeainet.
English: The CHMP decided that, in accordance with EU requirements, Valtropin has been shown to have a comparable quality, safety and efficacy profile to Humatrope.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Valtropini võrdväärne kvaliteet ning ohutus- ja efektiivsusprofiil ravimiga Humatrope.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Valtropin.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The doctor calculates the dose for each patient individually, depending on the body weight and condition, and may need to adjust it over time, depending on changes in body weight and response.
Estonian: Arst arvutab igale patsiendile tema kehakaalu ja haigust arvesse võttes sobiva annuse, mida võib tarvis olla aja jooksul kohandada vastavalt kehakaalu ja ravivastuse muutumisele.
English: • children from two years of age and adolescents who fail to grow because they lack growth hormone (replacement therapy);
Estonian: • vähemalt 2-aastased lapsed ja noorukid, kes kasvuhormooni puudulikkuse tõttu ei kasva (asendusravi);
English: Valtropin is also used to treat adults with pronounced growth hormone deficiency, which has started in adulthood or childhood and needs to be confirmed by testing before treatment (replacement therapy).
Estonian: Valtropini kasutatakse ka täiskasvanud patsientidel, kellel on väljendunud kasvuhormooni puudulikkus, mis võis olla alanud täiskasvanu- või lapseeas ning enne ravi algust on vaja diagnoosi analüüsidega kinnitada (asendusravi).
English: This is a summary of the European public assessment report (EPAR) for Valtropin.
Estonian: Käesolev dokument on ravimi Valtropin Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Valtropin
Estonian: Muu teave Valtropini kohta
English: The most common side effects with Valtropin are reactions at the site of injection and hormonal changes, and, in adults, headache, paraesthesia (unusual sensation like pins and needles), arthralgia (joint pain) and joint disorders.
Estonian: Valtropini kõige sagedamad kõrvalnähud on süstekoha reaktsioonid ja hormonaalsed muutused ning täiskasvanutel peavalu, paresteesia (vääraistingud, nt torkiv valu), liigesevalu ja -põletik.
English: • children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Estonian: • lapsed, kellel on Turneri sündroomi (harva esinev tüdrukute geneetiline häire) tõttu tekkinud kasvupeetus, kui sündroomi olemasolu on tõestatud DNA-analüüsiga;
English: For more information about treatment with Valtropin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Valtropiniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Why has Valtropin been approved?
Estonian: Miks Valtropin heaks kiideti?
English: The active substance in Valtropin, somatropin, is identical to human growth hormone.
Estonian: Valtropini toimeaine somatropiin on inimese kasvuhormooniga identne.
English: Valtropin contains the active substance somatropin.
Estonian: Valtropin sisaldab toimeainena somatropiini.
English: What is Valtropin?
Estonian: Mis on Valtropin?
English: Valtropin must not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Estonian: Valtropini ei tohi kasutada kasvu soodustamiseks lastel, kellel on epifüüsid luustunud (toruluud on lõpetanud kasvamise).
English: Valtropin should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the solvent for Valtropin contains metacresol).
Estonian: Valtropini ei tohi kasutada patsiendid, kes võivad olla somatropiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised) (Valtropini lahusti sisaldab metakresooli).
English: Valtropin replaces the natural hormone.
Estonian: Valtropin asendab kehaomast hormooni.
English: This was considered sufficient to demonstrate that the benefits of Valtropin are comparable to those of the reference medicine.
Estonian: Seda peeti piisavaks, et näidata Valtropini ja selle võrdlusravimi kasulikkuse võrreldavust.
English: Valtropin was studied to show that it is comparable to the reference medicine, Humatrope.
Estonian: Valtropini uuriti, et näidata selle võrreldavust võrdlusravimiga Humatrope.
English: Valtropin is a powder and solvent that are made up into a solution for injection.
Estonian: Valtropin on pulber ja lahusti, millest valmistatakse süstelahus.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a yeast that has received a gene (DNA) that makes it able to produce somatropin.
Estonian: Seda valmistatakse rekombinant-DNAtehnika abil: hormooni toodab pärm, millele on lisatud somatropiini teket võimaldav geen (DNA).
English: Valtropin is given by injection under the skin, once a day.
Estonian: Valtropini manustatakse nahaaluse süstina üks kord ööpäevas.
English: • children before puberty, who fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Estonian: • puberteedieelsetel lastel, kelle kasvupeetuse põhjuseks on pikaajaline neeruhaigus (krooniline neerupuudulikkus).
English: For the full list of all side effects reported with Valtropin, see the package leaflet.
Estonian: Valtropini kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The reference medicine for Valtropin is Humatrope.
Estonian: Valtropini võrdlusravim on Humatrope.
English: The patient or caregiver can inject Valtropin after training by a doctor or a nurse.
Estonian: Kui patsient või tema hooldaja on saanud arstilt või õelt asjakohase väljaõppe, tohivad nad süstida Valtropini ka ise.
English: Valtropin must not be used when the patient suffers from an active tumour, or a life-threatening illness.
Estonian: Valtropini ei tohi kasutada aktiivse kasvajaga või eluohtliku haigusega patsientidel.
English: Valtropin treatment should be supervised by a doctor experienced in the management of patients with growth disorders.
Estonian: Ravi Valtropiniga võib toimuda üksnes kasvuhäiretega patsientide ravis kogenud arsti järelevalve all.
English: How does Valtropin work?
Estonian: Kuidas Valtropin toimib?
English: Valtropin is a ‘biosimilar' medicine.
Estonian: Valtropin on bioloogiliselt sarnane ravim.
English: What is the risk associated with Valtropin?
Estonian: Mis riskid Valtropiniga kaasnevad?
English: The site of injection must be varied to avoid lipoatrophy (loss of fat below the skin).
Estonian: Lipoatroofia (nahaaluse rasvkoe kadumine) tekke vältimiseks peab süstekohta muutma.
English: What benefit has Valtropin shown during the studies?
Estonian: Milles seisnes uuringute põhjal Valtropini kasulikkus?
English: How is Valtropin used?
Estonian: Kuidas Valtropini kasutatakse?
English: What is Valtropin used for?
Estonian: Milleks Valtropini kasutatakse?
English: How has Valtropin been studied?
Estonian: Kuidas Valtropini uuriti?
English: This occurs in both men and women of all ages.
Estonian: See esineb nii meestel kui ka naistel igas vanuses.
English: Total BMD also increased significantly.
Estonian: Kogu BMD suurenes samuti oluliselt.
English: ATC code: M05BA04
Estonian: ATC-kood: M05BA04
English: Placebo (n=397)
Estonian: Platseebo (n = 397)
English: The relevance for humans is unknown.
Estonian: Selle tähtsus inimesele ei ole teada.
English: • Hypocalcaemia.
Estonian: • Hüpokaltseemia.
English: *See section 4.2 and 4.4.
Estonian: * Vt lõigud 4.2 ja 4.4.
English: Protein binding in human plasma is approximately 78%.
Estonian: Seondumine valkudega inimplasmas on umbes 78%.
English: These studies involved a total of 560 patients aged 17-83 years.
Estonian: Need uuringud hõlmasid 560 patsienti vanuses 17…83 aastat.
English: Talk to your doctor first and follow the advice given.
Estonian: Rääkige esmalt oma arstiga ja järgige tema nõuandeid.
English: 14, 28, 56, 98, 112 and 50 x 1 (unit dose).
Estonian: 14, 28, 56, 98, 112 ja 50 x 1 (üksikannus).
English: It will help if you make a note of what you experienced, when it started and how long it lasted.
Estonian: Abiks on, kui täheldate üles, millised sümptomid tekkisid, millal need algas ja kaua kestsid.
English: These are usually slight and asymptomatic.
Estonian: Need on tavaliselt vähesed ja asümptomaatilised.
English: Like muscles, bones need exercise to stay strong and healthy.
Estonian: Nagu lihased, vajavad ka luud treeningut, et püsida tugevate ja tervetena.
English: A causal relationship cannot be excluded (see section 4.8).
Estonian: Põhjuslikku seost ei saa välistada (vt lõik 4.8).
English: • Inability to stand or sit upright for at least 30 minutes.
Estonian: • Võimetus seista või sirgelt istuda vähemalt 30 minuti jooksul.
English: Plasma concentrations fell by more than 95% within 6 hours following intravenous administration.
Estonian: Plasma kontsentratsioonid langesid rohkem kui 95% 6 tunni jooksul pärast intravenoosset manustamist.
English: Consult your doctor before you begin any exercise programme.
Estonian: Pidage nõu oma arstiga, enne kui alustate mingi treeningprogrammiga.
English: Conventional studies of general toxicity, genotoxicity and carcinogenicity did not reveal any special risks for humans.
Estonian: Tavapärased üldise toksilisuse, genotoksilisuse ja kartsinogeensuse uuringud ei ole näidanud mingeid erilisi ohte inimesele.
English: If you think any of these apply to you, do not take the tablets.
Estonian: Kui arvate, et mõni eelnevaist punktidest kehtib teie kohta, ärge võtke tablette.
English: Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Estonian: Raviarsti kliiniline hinnang peab juhtima iga patsiendi raviplaani, põhinedes individuaalsel kasu/riski hindamisel.
English: Do not lie down until after your first food of the day.
Estonian: Ärge heitke pikali enne päeva esimest söögikorda.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Estonian: Ravi ajal peavad need patsiendid võimalusel vältima invasiivseid hambaraviprotseduure.
English: Very rare: < 1/10,000, not known (cannot be estimated from the available data)
Estonian: Väga harv: <1/10 000, ei ole teada (ei saa hinnata olemasolevate andmete alusel)
English: The time to onset of symptoms varied from one day to several months after starting treatment.
Estonian: Sümptomite algusaeg varieerus ühest päevast kuni mitme kuuni pärast ravi algust.
English: Talk to your doctor if you suffer from cancer or if your teeth are in bad condition as this is a risk factor.
Estonian: Rääkige arstile, kui teil on vähk või kui teie hambad on halvas seisukorras, sest see on riskifaktoriks.
English: Most patients had relief of symptoms after stopping treatment.
Estonian: Enamusel patsientidest leevenesid sümptomid pärast ravi peatamist.
English: The incidence of new vertebral fractures was evaluated as a safety variable.
Estonian: Uute lülisamba lülide esinemissagedust hinnati ohutuse muutujana.
English: - Do not take with coffee or tea.
Estonian: - Ärge võtke ravimit koos kohvi või teega.
English: Always take Alendronate HEXAL exactly as your doctor has told you.
Estonian: Kasutage Alendronat HEXALi alati täpselt nii, nagu arst on teile rääkinud.
English: If you miss a dose, just take one tablet on the morning after you remember.
Estonian: Kui üks annus jääb vahele, võtke pärast meenumist järgmisel hommikul üks tablett.
English: The CHMP has recommended the following indication, which is in accordance with the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CHMP/EWP/552/95 Rev.2)
Estonian: soovitas inimtervishoius kasutatavate ravimite komitee järgmist näidustust, mis vastab suunisele esmase osteoporoosi raviks kasutatavate ravimite hindamiseks (CHMP/EWP/552/95 Rev.2)
English: - Do not take with juice or milk.
Estonian: - Ärge võtke ravimit koos mahla või piimaga.
English: Alendronate belongs to a group of non-hormonal medicines called bisphosphonates.
Estonian: Alendronaat kuulub mittehormonaalsete ravimite rühma, mida nimetatakse bisfosfonaatideks.
English: See also section 4.4 .
Estonian: Vt ka lõik 4.4.
English: 7) It is important that you continue taking Alendronate HEXAL for as long as your doctor prescribes the medicine.
Estonian: 7) On tähtis, et jätkaksite Alendronat HEXALi võtmist nii kaua, kui arst on ravimit määranud.
English: Long-term use of steroids is often associated with the development of osteoporosis accompanied by fractures.
Estonian: Pikaajaline steroidide kasutamine on sageli seotud osteoporoosi arenguga, millega kaasnevad luumurrud.
English: Therefore no adjustment of the dose is necessary for elderly patients.
Estonian: Seetõttu ei ole eakatel patsientidel annuse kohandamine vajalik.
English: For oral use only.
Estonian: Ainult peroraalseks kasutamiseks.
English: In addition, BMD at the femoral neck and total body was maintained.
Estonian: Lisaks jäi BMD reieluu kaelas ja kogu organismis samaks.
English: The tablets are supplied in triplex blister (PVC/PE/PVDC/AL) packs containing 14, 28, 56, 98, 112 and 50 x 1 (unit dose).
Estonian: Tabletid on saadaval kolme blistriga (PVC/PE/PVDC/AL) pakendites, mis sisaldavad 14, 28, 56, 98, 112 ja 50 x 1 (üksikannus) tabletti.
English: 3) Do not lie down - stay fully upright (sitting, standing or walking) - for at least 30 minutes after swallowing the tablet.
Estonian: 3) Ärge heitke pikali - ajage selg sirgu (istudes, seistes või käies) - vähemalt 30 minutiks pärast tableti allaneelamist.
English: 2) Do not chew the tablet or allow it to dissolve in your mouth.
Estonian: 2) Ärge närige tabletti ega laske sel suus lahustuda.
English: If you take more Alendronate HEXAL than you should If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Estonian: Kui te kasutate Alendronat HEXALi rohkem kui ette nähtud Kui võtate kogemata liiga palju tablette, jooge terve klaas piima ja võtke kohe ühendust oma arstiga.
English: Biotransformation There is no evidence that alendronate is metabolised in animals or humans.
Estonian: Biotransformatsioon Puuduvad tõendid, et alendronaat inimestel või loomadel metaboliseerub.
English: Bone formed during treatment with alendronate is of normal quality.
Estonian: Alendronaatravi ajal formeerunud luu on normaalse kvaliteediga.
English: Alendronate HEXAL should not be given to children and adolescents.
Estonian: Alendronat HEXAL-i ei tohi anda lastele ega noorukitele.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/PE/PVDC/AL
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA BLISTERPAKENDIL PVC/PE/PVDC/AL
English: Three-year studies Alendronate10 mg daily (n=196)
Estonian: Kolmeaastased uuringud Alendronaat 10 mg päevas (n = 196)
English: This medicinal product is authorised in the Member States of the EEA under the following names:>
Estonian: See ravimpreparaat on saanud müügiloa Euroopa Majanduspiirkonna liikmesriikides järgmiste nimetustega:
English: Patients should be informed that the risk of oesophageal problems may increase if they do not follow these instructions.
Estonian: Patsiendile tuleb öelda, et söögitoru probleemide risk võib suureneda, kui ta ei täida juhiseid.
English: The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton.
Estonian: Terminaalne poolväärtusaeg inimestel ületab hinnanguliselt 10 aastat, peegeldades alendronaadi vabanemist luustikust.
English: Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approx. 60 %.
Estonian: Samaaegne alendronaadi manustamine koos kohvi või apelsinimahlaga vähendas biosaadavust umbes 60% võrra.
English: Concentrations of active substance in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml).
Estonian: Toimeaine kontsentratsioonid plasmas pärast terapeutilisi suukaudseid annuseid on liiga madalad analüütiliseks avastamiseks (<5 ng/ml).
English: • FIT 2: A four-year study with 4432 patients who had a low bone mass but had not had any vertebral fracture at the start of the study.
Estonian: • FIT 2: neli aastat väldanud 4432 patsiendi uuring, kellel oli väike luumass, kuid uuringu alguses ei olnud veel esinenud ühtegi lülisamba lüli murdu.
English: Bioavailability decreased to an estimated 0.46 % and 0.39 % when alendronate was given an hour or half an hour before a standardised breakfast.
Estonian: Biosaadavus vähenes hinnangulise 0,46% ja 0,39%-ni, kui alendronaati manustati tund või pool tundi enne standardiseeritud hommikusööki.
English: In the two-year extensions of these studies the BMD in the spine and trochanter continued to increase.
Estonian: Nende uuringute kaheaastase pikenduse jooksul jätkas lülisamba seljaosa ja suure pöörli BMD suurenemist.
English: In clinical trials there was no age-related difference with regard to efficacy or safety profiles of alendronate.
Estonian: Kliinilistes uuringutes ei esinenud vanusega seotud erinevust seoses alendronaadi tõhusus- või ohutusprofiiliga.
English: The following undesirable effects have also been reported in clinical trials and/or post marketing:
Estonian: Järgnevatest kõrvaltoimetest on samuti teatatud kliinilistes uuringutes ja/või turustamisjärgselt.
English: The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Estonian: Enamus neist teadetest puudutavad vähihaigeid patsiente, kuid sellistest juhtudest on teatatud ka osteoporoosiravi saanud patsientidel.
English: Patients must therefore wait for at least 30 minutes after taking alendronate before taking any other oral medicine (see section 4.2).
Estonian: Seetõttu peavad patsiendid ootama vähemalt 30 minutit pärast alendronaadi kasutamist, enne kui nad võtavad mingeid muid suukaudseid ravimeid (vt lõik 4.2).
English: Causes of osteoporosis other than oestrogen deficiency, ageing and glucocorticoid use should be considered.
Estonian: Tuleb kaaluda muid osteoporoosi põhjuseid peale östrogeenide puuduse, vananemise ja glükokortikoidide kasutamise.
English: If you have been told by your doctor that you have an intolerance to some sugars (for example lactose), contact your doctor before taking this medicine.
Estonian: Kui teie arst on teile öelnud, et te ei talu mõningaid suhkruid (näiteks laktoosi), pidage enne ravimi võtmist nõu oma arstiga.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Estonian: LISA I RAVIMI NIMETUSTE, RAVIMVORMI, TUGEVUSE, MANUSTAMISVIISI, TAOTLEJA, MÜÜGILOA HOIDJA LOETELU LIIKMESRIIKIDES
English: The Applicant submitted an extensive review of the literature concerning the treatment of osteoporosis in men.
Estonian: Taotleja esitas põhjaliku ülevaate kirjandusest osteoporoosi ravi kohta meestel.
English: In postmarketing experience, these symptoms have rarely been seen and/or incapacitating (see section 4.8).
Estonian: Turustamisjärgse kogemuse alusel on need sümptomid esinenud harva, samuti on nad harva põhjustanud töövõimetust (vt lõik 4.8).
English: 50 x 1 (unit dose) tablet
Estonian: 50 x 1 (üksikannuse) tabletti
English: Osteoclastic activity is inhibited, but formation and binding of the osteoclasts is not affected.
Estonian: Osteoklastiline aktiivsus on inhibeeritud, kuid osteoklastide formeerumine ja seondumine ei ole mõjutatud.