FrancophonIA/ELRC3.0 huggingface dataset:
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Estonian: Kliiniliste uuringute tulemused luustikuga seotud tüsistuste vältimisel luukude haarava kaugelearenenud pahaloomulise kasvajaga patsientidel Esimeses randomiseeritud, topeltpimedas platseebokontrolliga uuringus võrreldi 4 mg zoledroonhappe ja platseebo efektiivsust luustikuga seotud tüsistuste - LST (Skeletal Related EventsSREs) vältimises prostatavähiga patsientidel.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 VIAL
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 1 VIAALI KARP
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30 - 60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Estonian: Kerge kuni keskmise neerupuudulikkusega luumetastaasidega patsientidele kreatiniinikliirensiga 30…60 ml/min on ravi alustamiseks soovitatavad järgmised zoledroonhappe annused (vt lõik 4.4):
English: • Additional risk minimisation measures The MAH shall ensure that a patient reminder card regarding osteonecrosis of the jaw is implemented.
Estonian: Müügiloa hoidja tagab patsiendi lõualuu osteonekroosi meeldetuletuskaardi kasutusele võtmise.
English: To avoid potential incompatibilities, Zoledronic acid medac concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution or 5% glucose solution.
Estonian: Sobimatuse vältimiseks tuleb Zoledroonhape medac'i kontsentraati lahjendada 0,9% naatriumkloriidivõi 5% glükoosilahusega.
English: Episcleritis
Estonian: segasusseisund
English: Pyrexia, fatigue Acute phase reaction, pain
Estonian: Ägeda faasi reaktsioon, valu
English: How to store Zoledronic acid medac
Estonian: Kuidas Zoledroonhape medac'it säilitada
English: - High blood pressure, shortness of breath, dizziness, sleep disturbances, taste disturbances,
Estonian: - Kõrge vererõhk, õhupuudus, pearinglus, unehäired, maitsetundlikkuse häired, värinad, käte või jalgade surisemine või tuimus, kõhulahtisus, kõhuvalu, suukuivus.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Zoledroonhape medac 4 mg/100 ml infusioonilahus
English: Manufacturer Sanochemia Pharmazeutika AG
Estonian: Sanochemia Pharmazeutika AG Landegger Straße 7
English: LABEL ON MULTIPACKS WITH 4 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Estonian: LÄBIPAISTVASSE KILESSE PAKITUD 4 PUDELIGA MITMIKPAKENDI ETIKETT (KOOS "BLUE BOX'IGA")
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Estonian: Zoledroonhappe manustamisel on patsientidel täheldatud kliinilistes uuringutes aeg-ajalt ja turuletuleku järgselt lõualuu osteonekroosi (LON).
English: Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Estonian: Raske neerupuudulikkusega TIH patsientidel võib ravi zoledroonhappega alustada vaid pärast võimaliku riski/eeldatava kasu suhte hindamist.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer)
Estonian: Tabel 3: Kliinilise uuringu tulemuste kokkuvõte (soliidtuumoritega patsiendid, v.a. prostata- ja rinnavähk)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/001<1 vial>
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/779/001 <1 vial> EU/1/12/779/007<4 vials>
English: Zoledronic acid medac belongs), or any of the other ingredients of this medicine (listed in section 6).
Estonian: Teile ei tohi Zoledroonhape medac'it anda: - kui olete zoledroonhappe, mõne teise bisfosfonaadi (ravimirühm, millesse Zoledroonhape medac kuulub) või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline - kui toidate last rinnaga.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg of zoledronic acid (as monohydrate).
Estonian: TOIMEAINE(TE) SISALDUS Üks viaal sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: Anaemia
Estonian: Naatrium
English: LABEL ON MULTIPACKS WITH 10 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Estonian: LÄBIPAISTVASSE KILESSE PAKITUD 10 VIAALIGA MITMIKPAKENDI ETIKETT (KOOS "BLUE BOX"-IGA)
English: Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 cartons each containing 1 bottle.
Estonian: Zoledroonhape medac'it turustatakse pakendis, mis sisaldab 1 pudelit, või 4 või 10 karbiga mitmikpakendites, millest igas on 1 pudel.
English: LABEL ON MULTIPACKS WITH 10 BOTTLES WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Estonian: LÄBIPAISTVASSE KILESSE PAKITUD 10 PUDELIGA MITMIKPAKENDI ETIKETT (KOOS "BLUE BOX'IGA")
English: STATEMENT OF ACTIVE SUBSTANCE(S) One bottle contains 4 mg of zoledronic acid (as monohydrate).
Estonian: TOIMEAINE(TE) SISALDUS Üks pudel sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Estonian: Tabel 6: Raskekujulise osteogenesis imperfecta'ga lastel täheldatud kõrvaltoimed (uuringud H2202/H2202E1)1
English: Zoledronic acid medac is supplied as packs containing 1 bottle or multipacks of 4 or 10 packs each containing 1 bottle.
Estonian: Zoledroonhape medac'it turustatakse ühte pudelit sisaldava pakendina või mitmikpakenditena, mis koosnevad 4 või 10 pakendist, igaühes üks pudel.
English: 1.0 mg/dl or 88 µmol/l.
Estonian: 30 ng/ml kuni 5000 ng/ml.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Estonian: RAVIMPREPARAADI NIMETUS Zoledroonhape medac 4 mg/100 ml infusioonilahus Acidum zoledronicum
English: Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 packs each containing 1 vial.
Estonian: Zoledroonhape medac'it turustatakse üksikpakendis, milles on 1 viaal või 4 viaali, või 4 või 10 pakendiga mitmikpakendis, igas pakendis 1 viaal.
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Estonian: Kuni seisundi paranemiseni ja võimaluse korral riskitegurite leevendamiseni tuleb kaaluda ravi ajutist katkestamist zoledroonhappega.
English: Table 7: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders Common:
Estonian: Tabel 7: Raskekujulise osteogenesis imperfecta'ga lastel täheldatud kõrvaltoimed (uuringud H2202/H2202E1)1
English: Tell your doctor and dentist immediately if you experience such symptoms while being treated with Zoledronic acid medac or after stopping treatment.
Estonian: Kui teil esinevad ravi ajal või pärast ravi lõpetamist Zolendroonhape medac'iga need sümptomid, rääkige sellest kohe oma arstile ja hambaarstile.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Zoledroonhape medac 4 mg/5 ml infusioonilahuse kontsentraat
English: Do not mix Zoledronic acid medac with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Estonian: Zoledroonhape medac'i ei tohi segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Estonian: Võtke ühendust oma arstiga, kui tunnete valu, nõrkust või ebamugavustunnet reies,
English: Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Estonian: - 4,4 ml kontsentraati 3,5 mg annuse valmistamiseks
English: Zoledronic acid medac contains sodium
Estonian: Mida Zoledroonhape medac sisaldab
English: Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 cartons each containing 1 vial.
Estonian: Zoledroonhape medac'it turustatakse üksikpakendis, milles on 1 viaal või 4 viaali, või 4 või 10 karbiga mitmikpakendis, igas pakendis 1 viaal.
English: − For patients with normal baseline serum creatinine (< 1.4 mg/dl or 124 µmol/l), an increase of
Estonian: (<1,4 mg/dl või 124 µmol/l); - kreatiniini sisalduse tõus 1,0 mg/dl või 88 µmol/l võrra, kui algväärtus ei olnud normi piires
English: LIST OF EXCIPIENTS
Estonian: uveiit episkleriit
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/779/005
English: EXP:
Estonian: SN:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL ON MULTIPACKS WITH 4 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Estonian: LÄBIPAISTVASSE KILESSE PAKITUD 4 VIAALIGA MITMIKPAKENDI ETIKETT (KOOS "BLUE BOX"-IGA)
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic acid medac or after stopping treatment.
Estonian: Kui teil esinevad Zoledroonhappe medac'iga ajal või pärast ravi lõppu sümptomitena valu, valuhoogude või jäikuse teke või ägenemine, rääkige sellest kohe oma arstile ja hambaarstile.
English: Very common: Common:
Estonian: Uuringud väga sage:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/779/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/002
Estonian: MÜÜGILOA NUMBER(NUMBRID) EU/1/12/779/002
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Estonian: Võimalike sobimatuste vältimiseks tuleks lahjendamiseks kasutada naatriumkloriidi 9 mg/ml (0,9%) süstelahust või 5-massi-mahuprotsendilist glükoosilahust.
English: PHARMACEUTICAL FORM AND CONTENTS
Estonian: MANUSTAMISVIIS JA -TEE
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Estonian: RAVIMPREPARAADI NIMETUS Zoledroonhape medac 4 mg/5 ml infusioonilahuse kontsentraat Acidum zoledronicum
English: LIST OF EXCIPIENTS Excipients: mannitol, sodium citrate, water for injections.
Estonian: ABIAINED Abiained: mannitool, naatriumtsitraat ja süstevesi.
English: - Chest pain.
Estonian: - Valu rinnus.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5 % (96 out of 3,862) and 1.9 % (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Estonian: ravis võrreldes platseeboga, oli kodade virvendusarütmia üldine esinemissagedus 5 mg zoledroonhapet või platseebot saanud patsientide seas vastavalt 2,5% (96 patsiendil 3862-st) ja 1,9% (75 patsiendil 3852-st).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cardalis on 23 July 2012.
Estonian: Euroopa Komisjon andis Cardalise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 23. juulil 2012.
English: It is available as chewable tablets (2.5 mg/20 mg, 5 mg/40 mg and 10 mg/80 mg).
Estonian: Ravimit turustatakse näritavate tablettidena (2,5 mg / 20 mg, 5 mg / 40 mg ja 10 mg / 80 mg).
English: The safety study showed Cardalis to have a good safety profile.
Estonian: Ohutusuuring näitas, et Cardalisel on hea ohutusprofiil.
English: A field study was conducted in dogs to demonstrate how well Cardalis tablets were taken and how easy they were to give.
Estonian: Koertel tehti väliuuring, et näidata, kui hästi Cardalise tablette võeti ja kui kerge oli neid anda.
English: The main measure of effectiveness was good treatment compliance, which was defined as dogs consuming at least 90% of their tablets.
Estonian: Efektiivsuse põhinäitaja oli ravi hea teostus, mis määratleti vähemalt 90% tablettide manustamisena koertele.
English: This is a type of heart disease where the heart cannot pump enough blood around the body.
Estonian: See on südamehaigus, mille korral süda ei suuda pumbata organismi piisavalt verd.
English: Other information about Cardalis:
Estonian: Muu teave Cardalise kohta
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Cardalis exceed the risks and recommended that be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et Cardalise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda Cardalise müügiloa.
English: The field study showed Cardalis to be voluntarily and fully consumed 92% of the time when offered with or without food and around 86% of dogs showed good compliance with treatment.
Estonian: Väliuuring näitas, et 92% Cardalise tablettidest, mis anti koos toiduga või ilma, tarbiti vabatahtlikult ja täielikult ja 86% koertest oli ravi hästi teostatav.
English: Spironolactone also works on the heart and blood vessels in other ways, although these mechanisms have not yet been fully demonstrated in dogs.
Estonian: Spironolaktoon toimib südamele ja veresoontele ka muude mehhanismide kaudu, kuigi nende esinemine koertel ei ole veel täielikult tõendatud.
English: People should wash their hands after handling the tablets.
Estonian: Pärast tablettide käsitsemist tuleb käsi pesta.
English: When the production of angiotensin II is lowered, the blood vessels relax and widen.
Estonian: Kui hormooni angiotensiin II tekib vähem, siis veresooned lõõgastuvad ja laienevad.
English: This allowed the existing field data on the single active substances to be applied to Cardalis.
Estonian: See võimaldab ainsa toimeainega korraldatud väliuuringute andmed üle kanda Cardalisele.
English: Cardalis is a veterinary medicine that contains two active substances, benazepril hydrochloride and spironolactone.
Estonian: Cardalis on veterinaarravim, mis sisaldab kahte toimeainet, benasepriilvesinikkloriidi ja spironolaktooni.
English: The tablets are given to the dog once a day with food at a dose of 0.25 mg benazepril hydrochloride and 2 mg spironolactone per kilogram bodyweight.
Estonian: Tablette manustatakse üks kord ööpäevas koos toiduga annuses 0,25 mg benasepriilvesinikkloriidi ja 2 mg spironolaktooni kehakaalu kg kohta.
English: The tablets may either be mixed with a small amount of food offered to the dog just before the main meal, or with the meal itself.
Estonian: Tabletid võib segada väikese söögikogusega, mis antakse koerale enne põhisöögikorda või segatuna põhisöögi sisse.
English: In the laboratory study, Cardalis was shown to be bioequivalent to combined treatment with products containing the single active substances (medicines are bioequivalent when they produce the same levels of active substance in the body).
Estonian: Laboriuuring näitas, et Cardalis oli bioekvivalentne individuaalseid toimeaineid sisaldavate ravimite kombineeritud raviga (ravimid on bioekvivalentsed, kui nad tekitavad organismis sama toimeainesisalduse).
English: Why has Cardalis been approved?
Estonian: Miks Cardalis heaks kiideti?
English: What is the risk associated with Cardalis?
Estonian: Mis riskid Cardalisega kaasnevad?
English: Cardalis is used for congestive heart failure caused by long-term damage to the heart valves.
Estonian: Cardalist kasutatakse, et ravida kongestiivset südamepuudulikkust, mida põhjustab pikaajaline südameklappide talitlushäire.
English: This allows the blood pressure to drop, reducing the load on the heart.
Estonian: See langetab vererõhku ja vähendab ühtlasi südame koormust.
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Estonian: Benaseprilaat on angiotensiini muundava ensüümi (ACE) inhibiitor.
English: By blocking aldosterone, spironolactone increases the elimination of salt and water in the urine.
Estonian: Aldosterooni toime blokeerimise teel suurendab spironolaktoon soola ja vee eritumist uriiniga.
English: What is Cardalis?
Estonian: Mis on Cardalis?
English: A six month safety study was also conducted in Beagle dogs at up to five times the recommended dose.
Estonian: Samuti korraldati hagijatel 6-kuuline ohutusuuring, milles kasutati soovitatavast annusest kuni 5 korda suuremat annust.
English: What is Cardalis used for?
Estonian: Milleks Cardalist kasutatakse?
English: The benefit/risk balance can be found in the scientific discussion module of this EPAR.
Estonian: Ravimi kasulikkuse ja riski tasakaalu teave on Euroopa avaliku hindamisaruande teadusliku arutelu kokkuvõttes.
English: Cardalis is used to treat dogs with congestive heart failure.
Estonian: Cardalist kasutatakse koerte kongestiivse südamepuudulikkuse ravimiseks.
English: This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
Estonian: See omakorda vähendab vere üldist mahtu, mistõttu südame koormus vere pumpamisel väheneb ja südametalitlus paraneb.
English: The company presented a laboratory study in Beagle dogs comparing treatment with spironolactone and benazepril as single active substances (in the products Prilactone and Fortekor which are already authorised in the EU) to treatment with Cardalis.
Estonian: Ettevõte esitas hagijatel (beagle) korraldatud laboriuuringu andmed, milles võrreldi spironolaktooni ja benasepriili kasutamisel ainsa toimeainena (ravimid Prilactone ja Fortekor, millel juba on Euroopa Liidus müügiluba) ja Cardalist.
English: It must not be used in dogs intended or used for breeding.
Estonian: Cardalist ei tohi kasutada koertel, keda kasutatakse või kavatsetakse kasutada tõuaretuses.
English: People with known hypersensitivity (allergy) to spironolactone or benazepril should avoid contact with Cardalis.
Estonian: Inimesed, kes on spironolaktooni või benasepriili suhtes teadaolevalt ülitundlikud (allergilised), peavad vältima kokkupuudet Cardalisega.
English: Benazepril hydrochloride / spironolactone
Estonian: Cardalis benasepriilvesinikkloriid/spironolaktoon
English: Pregnant women should take special care to avoid accidental oral exposure because ACE inhibitors have been found to affect the unborn child.
Estonian: Rasedad peavad olema eriti ettevaatlikud, et vältida tablettide juhuslikku neelamist, sest ACE-inhibiitorid võivad kahjustada loodet.
English: How does Cardalis work?
Estonian: Kuidas Cardalis toimib?
English: These studies demonstrated an increased survival in dogs treated concurrently with spironolactone and benazepril compared to benazepril alone.
Estonian: Uuringutes täheldati samal ajal spironolaktooni ja benasepriiliga ravitud koertel suuremat elulemust võrreldes ainult benasepriili saanud koertega.
English: Cardalis must not be used in dogs with Addison's disease or hypoadrenocorticism (a condition where the adrenal gland does not produce sufficient amounts of hormones), hyperkalaemia (increased blood potassium levels) or hyponatraemia (reduced blood sodium levels).
Estonian: Peale selle ei tohi Cardalist kasutada Addisoni tõve või hüpoadrenokortitsismiga (seisund, kus hormoonide teke neerupealistes on vähenenud), hüperkaleemia (vere liigne kaaliumisisaldus) või hüponatreemiaga (vere naatriumivaegus) koertel.
English: It must not be used in dogs which are hypersensitive (allergic) to ACE inhibitors or to any of the ingredients.
Estonian: Cardalist ei tohi manustada koertele, kes on ACE-inhibiitorite või ravimi mis tahes koostisaine suhtes ülitundlikud (allergilised).
English: Spironolactone blocks the actions of aldosterone, a hormone that causes the kidneys to retain salt and water within the body with harmful effects on the cardiovascular system.
Estonian: Spironolaktoon blokeerib aldosterooni toime; see on hormoon, mis põhjustab neerudes vedeliku- ja soolapeetuse, mis kahjustab kardiovaskulaarsüsteemi.
English: What benefit has Cardalis shown during the studies?
Estonian: Milles seisneb uuringute põhjal Cardalise kasulikkus?
English: Cardalis should be used with caution in dogs with liver damage as this may alter the way spironolactone is metabolised (processed) in the liver.
Estonian: Cardalise kasutamisel maksakahjustusega koertel tuleb olla ettevaatlik, sest see võib muuta spironolaktooni metabolismi (ainevahetust) maksas.
English: Cardalis must not be used in pregnant or lactating (milk producing) bitches as toxic effects for the foetus were seen in studies of benazepril in rats.
Estonian: Cardalist ei tohi samuti kasutada tiinetel või imetavatel koertel, sest rottidel toimunud uuringus täheldati benasepriilil toksilist toimet lootele.
English: Cardalis should not be given to growing dogs due to its effect on male sex hormones.
Estonian: Cardalist ei tohi toime tõttu isassuguhormoonidele manustada kasvueas koertele.
English: How has Cardalis been studied?
Estonian: Kuidas Cardalist uuriti?
English: Cardalis must not be used in cases of aortic or pulmonary stenosis (narrowing of the aorta or pulmonary blood vessels) affecting the heart's blood output.
Estonian: Cardalist ei tohi kasutada ka aordi või kopsuarteri stenoosi (ahenemise) korral, kui see takistab verevarustust.
English: Regular monitoring should continue in dogs with reduced kidney function as they may have an increased risk of hyperkalaemia (raised potassium levels in the blood) during treatment.
Estonian: Neerutalitluse puudulikkusega koertel tuleb neerutalitlust ravi ajal regulaarselt jälgida, sest neil võib olla hüperkaleemia (vere liigne kaaliumisisaldus) risk.
English: Kidney function and potassium levels in the blood should be monitored before start of treatment in all dogs.
Estonian: Enne ravi alustamist tuleb kõigil koertel kontrollida neerutalitlust ja vere kaaliumisisaldust.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Estonian: ACE-inhibiitorid vähendavad organismis tugevatoimelise vasokonstriktori (veresooni ahendava aine) hormooni angiotensiin II teket.
English: The company also presented the results of field studies with the individual active substances given as separate tablets, where the main measure of effectiveness was the number of dogs that died due to heart disease.
Estonian: Samuti esitas ettevõte väliuuringute andmed, kus manustati toimeaineid eraldi tablettidena.
English: Non-castrated male dogs treated with spironolactone may show atrophy (wasting) of the prostrate (a gland of the male reproductive system) that is reversible.
Estonian: Spironolaktooniga ravitavatel kastreerimata koertel võib tekkida eesnäärme atroofia (kõhetumine), mis on ravi lõpetamisel pöörduv.
English: What measures are being taken to ensure the safe and effective use of Lemtrada?
Estonian: Mis meetmed võetakse, et tagada Lemtrada ohutu ja efektiivne kasutamine?
English: Lemtrada received a marketing authorisation valid throughout the EU on 12 September 2013.
Estonian: Lemtrada on saanud müügiloa, mis kehtib kogu ELis, 12. septembril 2013.
English: • disease that is highly active, even though they have been treated with a disease-modifying therapy;
Estonian: • väga aktiivne haigus, isegi kui neid on ravitud haigust modifitseeriva raviga;
English: Further information on Lemtrada can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lemtrada
Estonian: Lisateave Lemtrada kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/lemtrada.
English: 1 See outcome of safety review carried out in 2019.
Estonian: 1Vt 2019. aastal koostatud ohutusteabe ülevaadet.
English: The European Medicines Agency decided that Lemtrada's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Lemtrada kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: What is Lemtrada and what is it used for?
Estonian: Mis on Lemtrada ja milleks seda kasutatakse?