natgillin/translations-raw huggingface dataset:
• are using anti-platelet agents such as aspirin, or low molecular weight heparin (which prevent blood clots).
• te kasutate tromboosivastased aineid, nt aspiriini või madalmolekulaarset hepariini (mis ennetavad verehüübeid); teie arst otsustab, kuidas teid tuleb ravida;
Each vial contains 10 mg caplacizumab.
Üks viaal sisaldab 10 mg kaplatsizumabi.
Step 5 - Prepare the syringe
Valmistage süstal ette.
• pre-filled syringe The pre-filled syringe contains 1 mL water for injections.
* Üks süstel lahustiga sisaldab 1 ml süstevett.
• Pull out the needle at the same angle you inserted it. Do not rub the injection site.
• Tõmmake nõel välja sama nurga all, nagu sisestasite.
Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Cablivi 10 mg süstelahuse pulber ja lahusti Kaplatsizumab (caplacizumabum)
STATEMENT OF ACTIVE SUBSTANCE Each vial of powder contains 10 mg caplacizumab.
TOIMEAINE(TE) SISALDUS Üks pulbriga viaal sisaldab 10 mg kaplatsizumabi.
Cablivi contains the active substance caplacizumab.
Cablivi sisaldab toimeainena kaplatsizumabi.
Place the tip of the syringe on the connector part of the vial adapter.
Asetage süstla ots viaaliadapteri ühendusosale.
• water for injections in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish.
Pärast pulbri lahustamist lahustis on lahus läbipaistev, värvitu või kergelt kollakas.
MARKETING AUTHORISATION NUMBERS EU/1/18/1305/002
MÜÜGILOA NUMBRID EU/1/18/1305/002
As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP.
Kaplatsizumab ennetab seetõttu omandatud trombootilisele trombotsütopeenilisele purpurile iseloomulikku ülisuurt trombotsüütide adhesiooni, mida vahendab von Willebrandi faktor.
• If you have any further questions, ask your doctor or pharmacist.
Kui teil on lisaküsimusi, pidage nõu oma arsti või apteekriga.
LIST OF EXCIPIENTS Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80.
ABIAINED Abiained: sahharoos, veevaba sidrunhape, trinaatriumtsitraatdihüdraat, polüsorbaat 80.
Marketing Authorisation Holder and Manufacturer Ablynx NV
Müügiloa hoidja ja tootja
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Cablivi 10 mg powder for injection caplacizumab IV and SC
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Cablivi 10 mg süstelahuse pulber caplacizumabum i.v./s.c.
• to mitigate the risk of serious bleeding episode particularly in emergency situations (e.g. accident) to inform physicians about the medical blockage of the von Willebrand Factor.
• teavitada arste tõsise verejooksu episoodi riski leevendamiseks, eriti erakorralistes olukordades
Haematuria*
Hematuuria*
• multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.
• mitmikpakina, mis sisaldab 7 viaali kaplatsizumabi pulbriga, 7 süstlit lahustiga, 7
• have severely reduced liver function.
• väga tugev menstruatsiooniverejooks;
MARKETING AUTHORISATION NUMBERS EU/1/18/1305/001
MÜÜGILOA NUMBRID EU/1/18/1305/001
NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection
RAVIMPREPARAADI NIMETUS Cablivi 10 mg süstelahuse pulber ja lahusti
Each pre-filled syringe of solvent contains 1 mL of water for injections.
Üks süstel lahustiga sisaldab 1 ml süstevett.
• single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
• Üksikpakk, mis sisaldab 1 viaali pulbriga, 1 süstlit lahustiga, 1 viaaliadapterit, 1 hüpodermilist nõela (30 G) ja 2 alkoholiga immutatud vatipatja.
Step 13 - After administration
13. samm.
Close monitoring for signs and symptoms of bleeding is recommended.
Soovitatav on hoolikas jälgimine veritsuse nähtude ja sümptomite osas (vt lõik 4.4.
It is unknown whether caplacizumab is excreted in human milk.
Ei ole teada, kas kaplatsizumab eritub rinnapiima.
• tiredness
• hingeldus;
Step 8 - Draw up solution
8. samm.
• black, tarry stools
• must, tõrvavärvi väljaheide;
PHARMACEUTICAL FORM Powder and solvent for solution for injection.
RAVIMVORM Süstelahuse pulber ja lahusti Valge lüofiliseeritud pulber.
• are using anticoagulants such as vitamin K antagonists , rivaroxaban, apixaban (which treat blood clots).
K-vitamiini antagoniste, rivaroksabaani, apiksabaani; teie arst otsustab, kuidas teid tuleb ravida;
Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to a lesser extent for factor VIII:C, in guinea pigs.
Lisaks täheldati farmakoloogilist von Willebrandi faktori antigeeni ja FVIII:C taseme langust jaava makaakidel ning vähemal määral FVIII:C langust merisigadel.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous and subcutaneous use For single use only
MANUSTAMISVIIS JA -TEE(D) Enne ravimi kasutamist lugege pakendi infolehte.
• bleeding gums
• verejooks pärasoolest;
• bruise
• Süstel
Step 4 - Attaching the adapter
Adapteri paigaldamine.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
RAVIMPREPARAADI NIMETUS Cablivi 10 mg süstelahuse pulber ja lahusti caplacizumabum
Citric acid anhydrous Trisodium citrate dihydrate Polysorbate 80
Sahharoos, veevaba sidrunhape, trinaatriumtsitraatdihüdraat, polüsorbaat 80.
Step 7 - Prepare the solution
4.7 Toime reaktsioonikiirusele
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT SYRINGE LABEL NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Cablivi
RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Cablivi lahusti
In the setting of concomitant use of anti-platelet agents and / or low molecular weight heparin (LMWH)
Trombotsüütide agregatsiooni inhibiitorite ja/või madalmolekulaarse hepariini samaaegne manustamine
• stroke
• veriköha;
Pyrexia, Fatigue
Püreksia, kurnatus
• bleeding from eye
• veritsus silmast;
Neuraceq florbetaben (
Neuraceq florbetabeen (
The European Commission granted a marketing authorisation valid throughout the European Union for Neuraceq on 20 February 2014.
Euroopa Komisjon andis Neuraceqi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil 20. veebruaril 2014.
The full EPAR and risk management plan summary for Neuraceq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Neuraceqi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A risk management plan has been developed to ensure that Neuraceq is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada Neuraceqi võimalikult ohutu kasutamine.
Neuraceq has been investigated in one main study involving 216 volunteers divided into two groups: a group of healthy young people and a group of patients nearing the end of their lives who had consented to autopsies when they died; 41 volunteers (10 healthy young people and 31 patients) completed the study and were included in the results.
Neuraceqi uuriti ühes põhiuuringus, milles osales 216 vabatahtlikku, kes jagati kahte rühma: tervete noorte rühm ja patsientide rühm, kelle elu hakkas lõppema ja kes nõustusid lahanguga pärast surma; uuringu lõpetas ka 41 vabatahtlikku (10 tervet noort inimest ja 31 patsienti), kes lisati tulemustesse.
Other information about Neuraceq
Muu teave Neuraceqi kohta
What measures are being taken to ensure the safe and effective use of Neuraceq?
Mis meetmed võetakse, et tagada Neuraceqi ohutu ja efektiivne kasutamine?
This means that the PET scans were able to correctly identify as positive 77.4% of the cases where patients had significant amounts of plaques, and that almost all patients without significant plaques were correctly rated as negative.
See tähendab, et PET-uuringud suutsid õigesti tuvastada positiivsena 77,4% juhtudest, mille puhul patsiendil oli olulisel määral naaste, ja et peaaegu kõik patsiendid ilma olulise hulga naastudeta hinnati õigesti kui negatiivsed.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Neuraceq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Inimravimite komitee otsustas, et Neuraceqi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
These data were further supported by the results from additional patients analysed after completion of the study.
Neid andmeid toetasid ka lisapatsientide tulemused, mida hinnati pärast uuringu lõppu.
The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence that early diagnosis following PET scans with Neuraceq and early management of treatment will improve patient outcomes.
Inimravimite komitee märkis siiski, et Alzheimeri tõve praegu olemasolevate ravimeetodite piiratud toimete tõttu puuduvad kindlad tõendid, et varane diagnoos pärast PET-uuringuid Neuraceqiga ja ravi varane algus parandavad patsientide lõpptulemusi.
When the results of the autopsies were compared with the PET scans, the scans were shown to have a sensitivity of 77.4% and a specificity of 94.2%.
Lahangutulemuste võrdlemisel PET-uuringutega selgus, et uuringute tundlikkus oli 77,4% ja spetsiifilisus 94,2%.
There is however a risk of false positive results, and therefore Neuraceq should not be used as the sole diagnostic method for dementia, but in conjunction with clinical evaluation.
Valepositiivsete tulemuste riski tõttu ei tohi aga Neuraceqi kasutada dementsuse ainukese diagnostilise meetodina, vaid seda tuleb kasutada koos kliinilise hindamisega.
Doctors will therefore need to use the scans together with clinical evaluation.
Seetõttu peavad arstid kasutama PET-kujutisi koos kliinilise hindamisega.
β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some elderly people with no symptoms.
Beeta-amüloidnaastud on ladestused, mis esinevad mõnikord dementsuse (Alzheimeri tõbi, Lewy kehakeste dementsus ja Parkinsoni tõve dementsus) põhjustatud mäluprobleemidega inimeste ajus ja samuti mõne sümptomiteta eaka inimese ajus.
This is a summary of the European public assessment report (EPAR) for Neuraceq.
See on ravimi Neuraceq Euroopa avaliku hindamisaruande kokkuvõte.
This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
See parandab oluliselt selliste mäluprobleemidega patsientide diagnoosimist, keda hinnatakse seoses Alzheimeri tõve ja teiste dementsuse tüüpidega.
Patients should discuss the results of their PET scan with their doctor.
Patsiendid peavad PET-uuringu tulemusi arutama oma arstiga.
Neuraceq delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Neuraceqi kiirituse kogus on väga väike minimaalse vähi- või mis tahes pärilike kõrvalekallete riskiga.
Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Neuraceq on süstelahus, mis sisaldab toimeainet florbetabeeni (18F) ja on ette nähtud ainult diagnostiliseks kasutamiseks.
What is Neuraceq and what is it used for?
Mis on Neuraceq ja milleks seda kasutatakse?
The medicine is given by injection into a vein about 90 minutes before obtaining an image from a PET scan.
Ravimit manustatakse veenisüstina umbes 90 minutit enne PET-kujutise tegemist.
The type of scan used with Neuraceq is called positronemission tomography (PET).
Uuringut Neuraceqiga nimetatakse positronemissioontomograafiaks (PET).
In addition, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Lisaks ei ole tuvastatud Neuraceqi kasulikkust mäluprobleemidega patsientide Alzheimeri tõve arengu prognoosimisel ja patsientide ravivastuse jälgimisel.
The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain, irritation and reddening of the skin at the site of injection.
Neuraceqi kõige sagedamad kõrvalnähud (võivad esineda kuni 1 patsiendil 10st) on süstekoha valulikkus, ärritus ja nahapunetus.
It is not intended to provide practical advice on how to use Neuraceq.
Hindamisaruandes ei anta Neuraceqi kasutamise praktilisi nõuandeid.
However, a positive scan on its own is not sufficient to make a diagnosis in patients with memory problems, as plaques may be seen with several types of dementia and also in some elderly people with no symptoms.
Siiski ei piisa positiivsest tulemusest mäluhäiretega patsiendi diagnoosimiseks, sest naaste võib esineda eri tüüpi dementsuse korral ja samuti mõnel sümptomita eakal inimesel.
The study looked at sensitivity and specificity of the PET scans (how well they identified volunteers with plaques in the brain and how accurate they were in distinguishing them from those who did not).
Uuringus vaadeldi PET-uuringute tundlikkust ja spetsiifilisust (kui hästi need tuvastasid vabatahtlikke, kelle ajus olid naastud, uuritavatest, kelle ajus naaste ei olnud).
Why is Neuraceq approved?
Miks Neuraceq heaks kiideti?
What are the risks associated with Neuraceq?
Mis riskid Neuraceqiga kaasnevad?
After the image is obtained, it is read by physicians specially trained in interpreting PET scans with Neuraceq.
Pärast kujutise tegemist vaatavad seda arstid, kes on saanud spetsiaalse väljaõppe Neuraceqiga tehtud PET-uuringute tulemuste tõlgendamises.
At the planned end of the study, 31 patients had died and had autopsies carried out on them to prove whether or not they had significant amounts of β-amyloid plaques in their brains.
Uuringu plaanitud lõpuks oli 31 patsienti surnud ja neile tehti lahangud, et kindlaks teha, kas neil oli ajus olulisel määral beetaamüloidnaaste.
The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Neuraceqi toimeaine florbetabeen (18F) on radiofarmatseutikumiks nimetatav ravim, mis emiteerib väikeses koguses kiirgust ja kinnitub beeta-amüloidnaastudele ajus.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neuraceq, including the appropriate precautions to be followed by healthcare professionals and patients.
Selle alusel lisati Neuraceqi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
After it attaches to the plaques, the radiation it emits can be detected by the PET scanner, enabling doctors to see whether or not significant amounts of plaques are present.
Pärast naastudele kinnitumist saab ravimi emiteeritavat kiirgust tuvastada PET-skanneriga, mis võimaldab arstidel näha, kas ajus leidub olulisel arvul naaste või mitte.
For practical information about using Neuraceq, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate Neuraceqi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
With regard to the safety profile of Neuraceq, this was considered reassuring, with the most common adverse events being related to injection site reactions.
Neuraceqi ohutusprofiili puhul peeti positiivseks seda, et enamus kõrvalnähte olid seotud süstekoha reaktsioonidega.
Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Neuraceqi kasutatakse mäluprobleemidega patsientide aju-uuringutel, et arstid saaksid tuvastada, kas patsientide ajus on olulisel määral beeta-amüloidnaaste.
Neuraceq can only be obtained with a prescription, and PET scans with Neuraceq should only be requested by doctors experienced in the management of patients with diseases such as Alzheimer's and other dementias.
Neuraceq on retseptiravim ja PET-uuringule Neuraceqiga peab suunama arst, kes on kogenud selliste haigustega (Alzheimeri tõbi ja muud dementsused) patsientide ravis.
How does Neuraceq work?
Kuidas Neuraceq toimib?
For more information about treatment with Neuraceq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Neuraceqiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
How is Neuraceq used?
Kuidas Neuraceqi kasutatakse?
Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Põhiuuringu tulemused näitasid, et PETuuringutel Neuraceqiga on kõrge tundlikkus ja spetsiifilisus beeta-amüloidnaastude avastamisel ajus ja et uuringutulemused olid sarnased lahangutulemustega.
What benefits of Neuraceq have been shown in studies?
Milles seisneb uuringute põhjal Neuraceqi kasulikkus?
For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Neuraceqi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
Selgus, et PET-uuringutel Neuraceqiga oli kõrge spetsiifilisus ja tundlikkus nende patsientide tuvastamisel, kelle ajus leidus olulisel arvul beeta-amüloidnaaste.
Xgeva has been authorised since July 2011.
Xgeva sai müügiloa alates juulist 2011.
The full European Public Assessment Report for Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Xgeva kohta on ameti veebilehel ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What is Xgeva?
Mis on Xgeva?
The company presented the results of a study involving 33 patients with hypercalcaemia.
Ettevõte esitas tulemused uuringu kohta, milles osales 33 hüperkaltseemiaga patsienti.
It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Ravimit kasutatakse patsientidel, keda ei saa ravida kirurgiliselt või kellel kirurgiline ravi põhjustaks raskeid probleeme.
The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Efektiivsuse põhinäitaja oli ravivastusega patsientide arv ning ravivastust määratleti vere kaltsiumisisalduse vähenemisena tasemele 2,9 mmol/l või alla selle 10 päeva jooksul alates esimese annuse manustamisest.
This reduces the loss of bone, making fractures and other serious bone complications less likely to happen, and also lowers calcium levels in the blood.
See vähendab luukoe hävimist, vähendades luumurdude ja muude luukahjustuste riski, ning vähendab ka kaltsiumisisaldust veres.
On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Amgen Europe BV teatas 13. jaanuaril 2017 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Xgeva taotlus Xgeva kasutamiseks pahaloomulisest kasvajast tingitud hüperkaltseemia (suur kaltsiumisisaldus veres) raviks.
High calcium levels are a serious complication that can affect cancer patients in the last stages of their disease.
Kaltsiumisisalduse suurenemine on raske tüsistus, mis võib esineda viimastes haigusstaadiumites vähipatsientidel.
By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
RANKLiga seondumise ja selle blokeerimisega vähendab denosumaab osteoklastide teket ja aktiivsust.
How does Xgeva work?
Kuidas Xgeva toimib?
Xgeva was not compared with any other treatment in this study.
Uuringus ei võrreldud Xgevat ühegi muu ravimiga.
What is happening with Xgeva for the prevention and treatment of other diseases?
Kuidas mõjutab taotluse tagasivõtmine Xgeva kasutamist teiste haiguste ennetamiseks/raviks?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.
Seetõttu oli inimravimite komitee taotluse tagasivõtmise ajal arvamusel, et uuringu tulemusi ei saa pidada piisavaks, ning otsustas, et ettevõtte esitatud andmete alusel ei saa ravimit heaks kiita.
These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Sellised luukahjustused on luumurrud, seljaaju kompressioon (seljaaju pitsumine luude vahel) või kiiritusravi või kirurgilist ravi vajavad kahjustused.
RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
RANKL osaleb osteoklastide ehk luukoe lagunemises osalevate organismirakkude aktiveerimises.
The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
Ettevõte teatas inimravimite komiteele, et Xgeva kliinilisi uuringuid ega eriloaga kasutamise programme praegu ei toimu.
Additionally, since patients were being treated with other hypercalcaemia treatments or had recently stopped treatment with bisphosphonates, it was not possible to determine the scale of the effect or whether the benefits observed in the study were due to Xgeva or were the effects of these other treatments.
Kuna patsiendid said ravi ka muude hüperkaltseemiaravimitega või olid hiljuti lõpetanud bisfosfonaatravi, ei olnud võimalik kindlaks määrata ravitoime määra ega seda, kas uuringus täheldatud kasulikkus oli seotud Xgeva või kõnealuste muude ravimitega.
The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients' condition had responded to bisphosphonates, as the patients' previous calcium levels were not available.
Inimravimite komitee tegi seoses põhiuuringuga kindlaks mitu probleemi, mille tõttu ei olnud komiteel võimalik teha lõplikke järeldusi Xgeva efektiivsuse kohta: uuringus ei võrreldud Xgevat ühegi muu ravimiga ning patsiendipopulatsioon oli väike, ühtlasi ei olnud piisavat kindlust bisfosfonaatravi toime suhtes patsientidel, kuna nende ravieelne kaltsiumisisaldus ei olnud teada.
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application because the CHMP considered the data provided insufficient to conclude that the benefits of Xgeva outweighed its risks in the treatment of hypercalcaemia caused by cancer.
Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et võtab taotluse tagasi, kuna inimravimite komitee arvates ei tõendanud esitatud andmed piisavalt, et Xgeva kasulikkus on vähist tingitud hüperkaltseemia ravis suurem kui sellega kaasnevad riskid.
What was Xgeva expected to be used for?
Milleks kavatseti Xgevat kasutada?