FrancophonIA/ELRC3.0 huggingface dataset:
English: There was also a lack of data on the long-term effects in a European population.
Estonian: Samuti puudusid andmed pikaajalise efektiivsuse kohta Euroopa patsientidel.
English: Ref.: EMA/814249/2009 EMEA/H/C/1034 EMEA/H/C/1122
Estonian: London, 19. november 2009 Viide: EMA/64538/2010 EMEA/H/C/1034 EMEA/H/C/1122
English: The cause of fibromyalgia is not known.
Estonian: Fibromüalgia tekkepõhjus ei ole teada.
English: The applicant requested a re-examination of the opinion.
Estonian: Müügiloa taotleja soovis arvamuse taasläbivaatamist.
English: The main measures of effectiveness were based on the patients perceived improvement in symptoms, particularly pain levels and their overall wellbeing.
Estonian: Efektiivsuse põhinäitaja põhines sellel, kuidas patsiendid hindasid oma sümptomite (eelkõige valu) ja üldise heaolu paranemist.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.
Estonian: Pärast taotluse põhjenduste kaalumist vaatas komitee oma algse arvamuse läbi ja kinnitas 19. novembril 2009 soovitust müügiloa andmisest keelduda.
English: Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Estonian: Fibromüalgia võib põhjustada ka muid sümptomeid, nagu puutetundlikkus, jäikus, väsimus, ärevus ning une-, tunde- ja mõttehäired.
English: Since these neurotransmitters are involved in reducing the sensation of pain, it was expected that blocking their re-uptake into nerve cells would improve the symptoms of fibromyalgia.
Estonian: Et need neurotransmitterid osalevad valuaistingu vähendamises, eeldati, et nende närvirakkudesse tagasihaarde blokeerimine vähendab fibromüalgia sümptomeid.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Estonian: Mis olid peamised probleemid, mille tõttu soovitas inimravimite komitee müügiloa andmisest keelduda?
English: Milnacipran Pierre Fabre Médicament/Impulsor was expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Estonian: Ravimit Milnacipran Pierre Fabre Médicament/Impulsor kavatseti kasutada fibromüalgia raviks täiskasvanud patsientidel; fibromüalgia on haigus, mis põhjustab pikaajalist ja levinud valu ning valulikke reaktsioone puudutusele.
English: In three main studies, 2,960 adult patients with fibromyalgia were given either Milnacipran Pierre Fabre Médicament/Impulsor or placebo (a dummy treatment) for around four to seven months.
Estonian: Kolmes põhiuuringus said kokku 2960 fibromüalgiaga täiskasvanud patsienti 4-7 kuu vältel ravimit Milnacipran Pierre Fabre Médicament/Impulsor või platseebot (näiv ravim).
English: The CHMP was of the opinion that the effect of the medicine was marginal.
Estonian: Inimravimite komitee leidis, et ravimi toime oli tagasihoidlik.
English: The company that applied for authorisation is Pierre Fabre Medicament.
Estonian: Müügiluba taotles ettevõte Pierre Fabre Médicament.
English: On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults.
Estonian: 23. juulil 2009 võttis inimravimite komitee vastu negatiivse arvamuse, soovitades täiskasvanute fibromüalgia raviks kasutada kavatsetud ravimi Milnacipran Pierre Fabre Médicament/Impulsor müügiloa andmisest keelduda.
English: It was expected to work by preventing the neurotransmitters 5hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Estonian: Ravim pidi pärssima neurotransmitterite 5-hüdroksütrüptamiini (serotoniin) ja noradrenaliini tagasihaaret peaaju ja seljaaju närvirakkudesse.
English: By blocking their re-uptake, milnacipran was expected to increase the level of communication between these nerve cells.
Estonian: Milnatsipraan pidi tagasihaarde blokeerimisega suurendama signaalivahetust närvirakkude vahel.
English: The CHMP refusal was confirmed after re-examination.
Estonian: Komitee kinnitas soovitust keelduda ka pärast taotluse taasläbivaatamist.
English: Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Estonian: Milnacipran Pierre Fabre Médicament/Impulsor on ravim, mis sisaldab toimeainena milnatsipraani.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Milnacipran Pierre Fabre Médicament/Impulsor in the treatment of fibromyalgia did not outweigh its risks.
Estonian: Seetõttu arvas inimravimite komitee negatiivse arvamuse vastuvõtmise ajal, et ravimi Milnacipran Pierre Fabre Médicament/Impulsor kasulikkus fibromüalgia ravis ei ole suurem kui sellega kaasnevad riskid.
English: The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Estonian: Ravimi Milnacipran Pierre Fabre Médicament/Impulsor toimeaine milnatsipraan on serotoniini ja noradrenaliini tagasihaarde inhibiitor.
English: The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Estonian: Ettevõte teatas inimravimite komiteele, et ravimi Milnacipran Pierre Fabre Médicament/Impulsor fibromüalgia ravis kasutamise kliinilist uuringut ega eriloaga kasutamise programmi praegu Euroopas ei toimu.
English: Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
Estonian: Müügiloa andmisest keeldumise soovituse teave Milnacipran Pierre Fabre Médicament/Impulsor milnatsipraan
English: What is Milnacipran Pierre Fabre Médicament/Impulsor?
Estonian: Mis on Milnacipran Pierre Fabre Médicament/Impulsor?
English: Hence, the CHMP recommended that Milnacipran Pierre Fabre Médicament/Impulsor be refused marketing authorisation.
Estonian: Milnacipran Pierre Fabre Médicament/Impulsor müügiloa andmisest keelduda.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Estonian: Kuidas mõjutab keeldumine praegu ravimi Milnacipran Pierre Fabre Médicament/Impulsor kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: What was Milnacipran Pierre Fabre Médicament/Impulsor expected to be used for?
Estonian: Milline on ravimi Milnacipran Pierre Fabre Médicament/Impulsor eeldatav toime?
English: The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti ravimi Milnacipran Pierre Fabre Médicament/Impulsor toimet muude katsetega.
English: However, such reports have been infrequent.
Estonian: Sellised teated ei ole olnud siiski sagedased.
English: Unopened bottle: 3 years.
Estonian: Avamata pudel: 3 aastat.
English: Please open here
Estonian: Avage siit
English: • At the request of the European Medicines Agency,
Estonian: • Euroopa Ravimiameti nõudel.
English: Not to be sold separately.
Estonian: Eraldi mitte müüa.
English: Your doctor will monitor this and take any necessary measures.
Estonian: Arst jälgib seda ja rakendab vajalikke meetmeid.
English: NA Not Applicable
Estonian: NA Pole kohaldatav
English: Adults and older people
Estonian: Täiskasvanud ja eakad
English: In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Estonian: Eelkõige puudusid selged tõendid efektiivsuse kohta luumurdude või valu korral.
English: Any SRE (+TIH)
Estonian: Kõik LST (+TIH)
English: In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Estonian: Enamikel juhtudel ei ole eriravi vajalik ja sümptomid kaovad lühikese aja (mõne tunni või päeva) jooksul.
English: Acquired Fanconi syndrome
Estonian: omandatud Fanconi sündroom
English: Patients aged 65 years and over
Estonian: Patsiendid vanuses 65 aastat ja eakamad
English: Children and adolescents Zometa is not recommended for use in adolescents and children below the age of 18 years.
Estonian: Lapsed ja noorukid Zometa't ei ole soovitatav kasutada alla 18-aastastel lastel ja noorukitel.
English: You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Estonian: Seetõttu peate te olema ettevaatlik auto juhtimisel, masinate käsitsemisel või suurt tähelepanu nõudvate tegevuste sooritamisel.
English: Low blood pressure.
Estonian: Madal vererõhk.
English: The response rate in these patients was about 52%.
Estonian: Neist umbes 52% reageerisid ravile.
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Estonian: Zoledroonhappe ohutus ja efektiivsus lastel vanuses 1 kuni 17 aastat ei ole tõestatud.
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Estonian: Farmakoterapeutiline rühm: luuhaiguste raviks kasutatavad ained, bisfosfonaadid, ATC-kood: M05BA08
English: In some instances the hypocalcaemia may be life-threatening.
Estonian: Mõningatel juhtudel võib hüpokaltseemia olla eluohtlik.
English: Increased sweating.
Estonian: Higistamise suurenemine.
English: In some instances, the hypocalcaemia may be life-threatening (see section 4.8).
Estonian: Mõnedel juhtudel võib hüpokaltseemia olla eluohtlik (vt lõik 4.8).
English: Use immediately after first opening.
Estonian: Kasutada koheselt peale avamist.
English: Very common (may affect more than 1 in 10 people): Low level of phosphate in the blood.
Estonian: Väga sage (võivad esineda rohkem kui 1 inimesel 10-st): Madal fosfaaditase veres.
English: Placebo Δ Zometa 
Estonian: Platseebo Δ Zometa 
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Estonian: Enne ravimi võtmist lugege hoolikalt infolehte, sest siin on teile vajalikku teavet.
English: What Zometa contains
Estonian: Mida Zometa sisaldab
English: Tell your doctor about any of the following serious side effects straight away:
Estonian: Rääkige oma arstile mis tahes järgneva tõsise kõrvaltoime esinemisest otsekohe:
English: Your doctor, pharmacist or nurse knows how to store Zometa properly (see section 6).
Estonian: Teie raviarst, apteeker ja meditsiiniõde teavad kuidas Zometa't õigesti säilitada (vt lõik 6).
English: Powder vial:
Estonian: Pulber viaalis:
English: If you are given more Zometa than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Estonian: Kui teile manustatakse Zometa't rohkem kui ette nähtud Kui te olete saanud soovitatust suuremaid annuseid, peab arst teid hoolega jälgima.
English: Time on study (weeks)
Estonian: Uuringu kestvus (nädalad)
English: Most patients had relief of symptoms after stopping treatment.
Estonian: Enamusel patsientidest on need sümptomid pärast ravi katkestamist leevendunud.
English: A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Estonian: Neerutalitluse häire, mida kutsutakse Fanconi sündroomiks (tavaliselt tuvastab teie arst selle teatud uriinianalüüsidega).
English: Subchronic and chronic toxicity
Estonian: Subkrooniline ja krooniline toksilisus
English: Baseline creatinine clearance (ml/min)
Estonian: Ravieelne kreatiniini kliirens (ml/min)
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Estonian: Paljud neist patsientidest said täiendavalt kemoteraapiat ning korikosteroide ja neil esinesid lokaalse infektsiooni tunnused, kaasa arvatud osteomüeliit.
English: Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Estonian: Tähelepanu tuleks pöörata ka ravi ajal tekkida võivale hüpomagneseemiale.
English: 1 bottle, 100 ml
Estonian: 1 pudel, 100 ml
English: What Zometa is and what it is used for
Estonian: Mis ravim on Zometa ja milleks seda kasutatakse
English: Median time to SRE (days)
Estonian: Keskmine aeg LSTni (päevad)
English: What you need to know before you are given Zometa
Estonian: Mida on vaja teada enne Zometa võtmist
English: Any unused solution should be discarded.
Estonian: Kasutamata lahus tuleb hävitada.
English: Date of first authorisation: 24.03.2003 Date of latest renewal: 20.03.2006
Estonian: Müügiloa esmase väljastamise kuupäev: 24.03.2003 Müügiloa viimase uuendamise kuupäev: 20.03.2006
English: • To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Estonian: • Kaltsiumisisalduse vähendamiseks veres täiskasvanud patsientidel juhtudel, kui see on kasvaja tõttu liiga kõrge.
English: Date of first authorisation: 20.03.2001 Date of latest renewal: 20.03.2006
Estonian: Müügiloa esmase väljastamise kuupäev: 20.03.2001 Müügiloa viimase uuendamise kuupäev: 20.03.2006
English: Zometa should not be used during pregnancy.
Estonian: Zometa't ei tohi kasutada raseduse ajal.
English: One vial 4 mg
Estonian: Üks viaal 4 mg
English: While being treated with Zometa, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Estonian: Zometa'ga ravi ajal tuleb teil säilitada korralikku suuhügieeni (sealhulgas regulaarne hammaste pesemine) ning käia regulaarselt hammaste kontrollis.
English: Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Estonian: Vanus, kehakaal, sugu ja kreatiniini kliirens ei paista zoledroonhappe süsteemsele ekspositsioonile mõju avaldavat.
English: Hypophosphataemia Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of Zometa (see section 4.8)
Estonian: Hüpofosfateemia Kõrvaltoimed esinemissagedusega <5% olid meditsiiniliselt hinnatud ning näidatud, et need juhtumid on kooskõlas Zometa ohutusandmetega (vt lõik 4.8).
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zometa.
Estonian: - Kui teid ravitakse vere kaltsiumisisalduse vähendamiseks, manustatakse teile üldjuhul ainult üks Zometa infusioon.
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Estonian: Kogukliirens on 5,042,5 l/t sõltumata annusest, soost, vanusest, rassist ja kehakaalust.
English: Painful redness and/or swelling of the eye.
Estonian: Silma valulik punetus ja/või turse.
English: There have been very rare cases of drowsiness and sleepiness with the use of Zometa.
Estonian: Väga harvadel juhtudel Zometa kasutamisel esinenud uimasust ja unisust.
English: Zoledronic acid was evaluated in rats for potential adverse effects on fertility of the parental and F1 generation.
Estonian: Rottidel uuriti zoledroonhappe võimalikke kõrvaltoimeid vanaloomade ja F1 põlvkonna fertiilsusele.
English: Caution is indicated when Zometa is used with other potentially nephrotoxic medicinal products.
Estonian: Ettevaatust nõuab Zometa kasutamine koos teiste potentsiaalselt nefrotoksiliste ravimitega.
English: if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of this medicine (listed in section 6).
Estonian: Kui olete zoledroonhappe, mõne teise bisfosfonaadi (ravimigrupp millesse Zometa kuulub) või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Estonian: Väliskuulmekanali osteonekroosi võimalike riskitegurite hulka kuuluvad steroidide kasutamine, keemiaravi ja/või lokaalsed riskitegurid, nagu infektsioon või trauma.
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Estonian: *Annuste arvutamisel on eeldatud, et AUC sihtväärtus on 0,66 (mg•hr/l) (CLcr = 75 ml/min).
English: Acute phase reaction, pain
Estonian: Ägeda faasi reaktsioon, valu
English: Each pack contains the vial with concentrate.
Estonian: Iga pakend sisaldab kontsentraadiga viaali.
English: Pam 90 mg
Estonian: Pamidronaat 90 mg
English: How often Zometa is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zometa every three to four weeks.
Estonian: Kui tihti Zometa't manustatakse - Kui teid ravitakse luumetastaasidest põhjustatud luutüsistuste ennetamiseks, manustatakse teile üks Zometa infusioon iga kolme kuni nelja nädala tagant.
English: White to off-white powder and clear, colourless solvent.
Estonian: Valge või valkjas pulber ja selge värvitu lahus.
English: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Estonian: JÄRGMINE TEAVE ON AINULT TERVISHOIUTÖÖTAJATELE
English: Cases of severe hypocalcaemia requiring hospitalisation have been reported.
Estonian: Teatatud on ka hospitaliseerimist vajavatest hüpokaltseemia rasketest juhtudest.
English: Acute phase reaction
Estonian: Akuutse faasi reaktsioon
English: Hyperkalaemia, hypernatraemia
Estonian: hüperkaleemia, hüpernatreemia
English: Follow carefully all instructions given to you by your doctor.
Estonian: Järgige täpselt arstilt saadud juhiseid.
English: Tell your doctor if you are or think that you may be pregnant.
Estonian: Informeerige arsti juhul, kui te olete rase või arvate et olete rasestunud.
English: It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
Estonian: Praegu ei ole selge, kas südame rütmihäireid põhjustab zoledroonhape; kui teil aga tekivad pärast zoledroonhappe manustamist sellised sümptomid, peate te sellest oma arstile teatama.
English: Low level of red blood cells (anaemia).
Estonian: Madal punaste vereliblede arv (aneemia).
English: There are no adequate data on the use of zoledronic acid in pregnant women.
Estonian: Zoledroonhappe kasutamise kohta rasedatel ei ole piisavalt andmeid.
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Estonian: Esimese 24 tunni jooksul eritub uriiniga 3916% manustatud annusest, ülejäänud seondub luukoega.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zometa.
Estonian: Kui teil esineb varasemalt hüpokaltseemia, tuleb see korrigeerida enne esimese Zometa annusega alustamist.
English: Women of child-bearing potential should be advised to avoid becoming pregnant.
Estonian: Fertiilses eas naistel tuleb soovitada rasestumist vältida.
English: For intravenous use only
Estonian: Ainult intravenoosseks manustamiseks
English: Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Estonian: Ravimata hüperkaltseemiaga patsientidel esineb tavaliselt mõningane neerupuudulikkus, seetõttu tuleb hoolikalt jälgida patsiendi neerufunktsiooni.
English: If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Estonian: Kui kaltsiumisisaldus on liiga madal, võib olla vaja manustada täiendavalt kaltsiumi infusiooni teel.
English: Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Estonian: Patsientidele manustati kas 4 mg zoledroonhapet või platseebot üks kord iga nelja nädala järel ühe aasta jooksul.
English: While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to zoledronic acid administration.
Estonian: Ravi ajal tuleb invasiivseid hambaprotseduure läbi viia ainult pärast hoolikat kaalumist ning protseduure vältida zoledroonhappe manustamisele lähedasel ajal.
English: Healthcare professionals are advised not to dispose of unused Zometa via the domestic sewage system.
Estonian: Tervishoiutöötajatel soovitatakse kasutamata Zometa lahust mitte kallata kanalisatsioonisüsteemi.
English: If any of these apply to you, tell your doctor straight away.
Estonian: Kui teil esineb mis tahes nendest loetletud kõrvaltoimetest, rääkige sellest oma arstile otsekohe.
English: Low counts of white blood cells and blood platelets.
Estonian: Madal valgete vereliblede ja vereliistakute arv.
English: One bottle contains 100 ml solution.
Estonian: Üks pudel sisaldab 100 ml lahust.
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Estonian: Hüpokaltseemia, hüpofosfateemia või hüpomagneseemia tekkimisel võib osutuda vajalikuks nende mineraalainete täiendav lühiajaline manustamine.
English: In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Estonian: Kliinilistes uuringutes jätkati ravi Zometa'ga alles siis, kui kreatiniini väärtus ei erinenud rohkem kui 10% algväärtusest (vt lõik 4.4).
English: The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Estonian: Enamik neist juhtudest on tekkinud vähihaigetel hambaekstraktsiooni või muude lõualuul teostatud kirurgiliste protseduuride järgselt.
English: Zometa can be given to people aged 65 years and over.
Estonian: Zometa't võivad kasutada ka 65-aastased ja vanemad patsiendid.
English: Angioneurotic oedema
Estonian: angioneurootiline turse
English: Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Estonian: Raske neerukahjustus (üldjuhul teeb selle spetsiaalsete vereanalüüsidega kindlaks arst).
English: Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Estonian: Patsientidele, kelle vere kaltsiumisisaldus ei ole liiga kõrge, määratakse igapäevaseks võtmiseks ka kaltsiumi ja D-vitamiini preparaate.
English: Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Estonian: Tõsine allergiline reaktsioon: hingeldus, peamiselt näo ja kurgu paistetus.
English: The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
Estonian: Bisfosfonaatide selektiivse toime aluseks on tugev afiinsus mineraliseerunud luu maatriksi suhtes, kuid osteoklastilise aktiivsuse inhibeerimise täpne toimemehhanism on endiselt ebaselge.
English: These could be signs of bone damage in the jaw (osteonecrosis).
Estonian: Need võivad olla lõualuu kahjustuse (osteonekroosi) märgid.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with Zometa has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Estonian: Antiangiogeenseid ravimeid (kasutatakse vähi ravimiseks), kuna nende kombinatsiooni Zometa'ga on seostatud suurenenud lõualuu osteonekroosi (LON) tekke riskiga.
English: Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Estonian: Osteonekroosi on täheldatud väga harva ka mujal kui lõualuus, eriti puusas või reies.
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1.
Estonian: • Ülitundlikkus toimeaine, teiste bisfosfonaatide või lõigus 6.1 loetletud mis tahes abiainete suhtes.