natgillin/translations-raw huggingface dataset:
It is given in combination with aspirin (acetylsalicylic acid) and where appropriate with a third medicine, clopidogrel, both of which also help prevent atherothrombotic events.
Seda manustatakse koos aspiriiniga (atsetüülsalitsüülhape) ja vajaduse korral koos kolmanda ravimi klopidogreeliga, mis samuti aitavad aterotrombootilisi tüsistusi ära hoida.
In this group, 8.5% of patients (719 out of 8,458 patients) treated with Zontivity had an atherothrombotic event, compared with 10.3% of patients (867 out of 8,439 patients) on placebo.
Selles rühmas oli aterotrombootiliste tüsistustega patsiente Zontivity uuringurühmas 8,5% (719 patsienti 8458st) ja platseeborühmas 10,3% (867 patsienti 8439st).
For more information about treatment with Zontivity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Zontivityga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
How does Zontivity work?
Kuidas Zontivity toimib?
Vorapaxar blocks the PAR-1 receptors (known as ‘thrombin receptors') on the surface of the platelets.
Vorapaksaar blokeerib trombotsüütide pinnal paiknevad PAR-1-retseptorid (trombiiniretseptorid).
It is given in combination with either aspirin or, where appropriate, with clopidogrel.
Seda antakse kas koos aspiriini või vajadusel koos klopidogreeliga.
Among patients with peripheral arterial disease, 10.9% (177 out of 1,622 patients) taking Zontivity had an atherothrombotic event compared with 12.5% (206 out of 1,651 patients) of patients taking placebo.
Perifeersete arterite haigusega patsiente, kellel esines aterotrombootilisi tüsistusi, oli Zontivity uuringurühmas 10,9% (177 patsienti 1622st) ja platseeborühmas 12,5% (206 patsienti 1651st).
The medicine has been shown to be beneficial in reducing the number of atherothrombotic events in patients who had had a heart attack.
Ravimi kasulikkus aterotrombootiliste tüsistuste arvu vähendamisel südameinfarkti anamneesiga patsientidel on tõestatud.
Zontivity is a medicine used to reduce the occurrence of atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes in adult patients who have already had a heart attack or who have peripheral arterial disease (problem with blood flow in the arteries) with symptoms.
Zontivity on ravim, mida kasutatakse aterotrombootiliste tüsistuste (trombidest ja arterite lubjastumisest põhjustatud probleemid), nt südameinfarktide või insultide esinemissageduse vähendamiseks südameinfarkti või perifeersete arterite haiguse (arteriverevoolu probleemi) anamneesiga täiskasvanud patsientidel.
How is Zontivity used?
Kuidas Zontivityt kasutatakse?
Blocking the PAR-1 receptor stops the platelets becoming sticky, reducing the risk of a blood clot forming and helping to prevent a stroke or heart attack.
PAR-1-retseptori blokeerimise tõttu ei kleepu trombotsüüdid kokku ja väheneb trombide tekkerisk, millega ennetatakse insulti või südameinfarkti.
Overall, 9.5% of patients (1,259 out of 13,225 patients) taking Zontivity had an atherothrombotic event compared with 10.7% (1,417 out of 13,224 patients) of patients taking placebo.
Kokku oli patsiente, kellel esines aterotrombootilisi tüsistusi, Zontivity uuringurühmas 9,5% (1259 patsienti 13 225st) ja platseeborühmas 10,7% (1417 patsienti 13 224st).
It therefore considered it appropriate to restrict the use to patients who have not had a stroke.
Seetõttu otsustas komitee, et ravimit tohivad võtta ainult patsiendid, kellel ei ole olnud insulti.
What benefits of Zontivity have been shown in studies?
Milles seisneb uuringute põhjal Zontivity kasulikkus?
The main measure of effectiveness was based on the number of patients having an ‘event' such as a heart attack or stroke, or dying from cardiovascular disease (problems affecting the heart and blood vessels).
Efektiivsuse põhinäitaja oli nende patsientide arv, kellel tekkis selline tüsistus, näiteks südameinfarkt või insult, või kes surid kardiovaskulaarse (südameveresoonkonna) haiguse tõttu.
For patients who have had a heart attack, treatment with Zontivity should start from 2 weeks after and preferably within one year of the occurrence of the heart attack.
Ravi Zontivityga tuleb alustada vähemalt 2 nädalat pärast südameinfarkti (soovitatavalt kuni ühe aasta jooksul pärast infarkti).
Zontivity must not be used together with prasugrel or ticagrelor, two other medicines that help to prevent platelets from sticking together.
Zontivityt ei tohi kasutada koos prasugreeli ega tikagrelooriga - ka need on toimeained, mis takistavad trombotsüütide kokkukleepumist.
Zontivity was more effective than placebo at reducing the occurrence of atherothrombotic events.
Zontivity oli aterotrombootiliste tüsistuste esinemissageduse vähendamisel efektiivsem kui platseebo.
It is given in combination with aspirin and where appropriate, clopidogrel.
Ravimit antakse koos aspiriiniga ja vajadusel koos klopidogreeliga.
The active substance in Zontivity, vorapaxar, is an inhibitor of platelet aggregation.
Zontivity toimeaine vorapaksaar on trombotsüütide agregatsiooni inhibiitor, mis aitab ennetada trombide (soonesiseste verehüüvete) tekkimist.
Immediate Packaging
Pakendi suuarus
EU/1/11/727/001 Xaluprine 20 mg/ml
EU/1/11/727/001 Xaluprine
1 bottle + 1 bottle adaptor + 2 oral syringes
1 pudel + 1 dosaator + 2 suusüstalt
Oral suspension Oral use bottle (glass); syringe (PET)
Pudel (klaas); süstal (PET)
Strength Pharmaceutical Form
Tugevus Ravimvorm Manustamisviis Pakendi iseloomustus
Packaging
Suukaudne
EMEA Number (Invented) name
(Väljamõeldud) nimetus
Hands and equipment should be washed and disinfected after use.
Käed ja seadmed tuleb pärast kasutamist pesta ning desinfitseerida.
Protection starts at 3 weeks after vaccination and lasts until 60 weeks after vaccination.
Kaitse algab 3 nädalat pärast vaktsineerimist ja kestab kuni 60 nädalat pärast vaktsineerimist.
The full EPAR for Evalon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Evaloni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Evalon is a vaccine.
Evalon on vaktsiin.
The vaccine suspension should be diluted with the solvent and water according to dosing instructions and sprayed onto the birds so that each bird receives one dose.
Vaktsiini suspensioon tuleb lahjendada lahusti ja veega annustusjuhiste järgi ning pihustada lindudele, nii et iga lind saab ühe annuse.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Evalon's benefits are greater than its risks and recommended that it be approved for use in the EU.
Veterinaarravimite komitee järeldas, et Evaloni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas vaktsiini kasutamise Euroopa Liidus heaks kiita.
It is also the time required after administration of a medicine before eggs may be used for human consumption.
See on ka aeg, mis peab ravimi manustamisest mööduma, enne kui mune tohib tarvitada inimtoiduks.
This is a summary of the European public assessment report (EPAR) for Evalon.
See on vaktsiini Evalon Euroopa avaliku hindamisaruande kokkuvõte.
This will help protect against coccidiosis.
See aitab kaitsta linde koktsidioosi eest.
The withdrawal period for meat and eggs from chickens treated with Evalon is ‘zero' days, which means there is no mandatory waiting time.
Evaloniga ravitud kanade liha ja munade keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
The results with Evalon and the comparator vaccine were similar for 3 out 4 farms; on 1 farm Evalon vaccinated chickens showed better protection than those given the comparator.
Evaloni ja võrdlusvaktsiini tulemused sarnanesid 3 farmis 4st; 1 farmis esines Evaloniga vaktsineeritud kanadel parem kaitse kui võrdlusvaktsiini saanud kanadel.
In the future if the animals are exposed to the same Eimeria species the immune system will be able to respond more quickly.
Kui linnud puutuvad hiljem samade Eimeria liikidega uuesti kokku, reageerib immuunsüsteem kiiremini.
What is Evalon and what is it used for?
Mis on Evalon ja milleks seda kasutatakse?
Why is Evalon approved?
Miks Evalon heaks kiideti?
Coccidiosis is a disease of the gut which results in reduced growth, severe diarrhoea, reduced egg production and a high death rate.
Koktsidioos on soolehaigus, mis põhjustab kasvupeetust, rasket kõhulahtisust, vähenenud munatoodangut ja suurt suremust.
It is not intended to provide practical advice on how to use Evalon.
Hindamisaruandes ei anta Evaloni kasutamise praktilisi nõuandeid.
Evalon is a veterinary vaccine to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Evalon on veterinaarvaktsiin kanade kaitsmiseks koktsidioosi eest, mida põhjustavad koktsiidparasiidid Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix ja Eimeria tenella.
The vaccine solvent contains the adjuvant montanide IMS to enhance the immune response.
Vaktsiini lahusti sisaldab immuunvastuse tugevdamiseks adjuvanti montaniid IMS.
The vaccine contains the oocysts of Eimeria species that have been weakened so that they cannot cause disease.
Vaktsiin sisaldab parasiidi Eimeria mitme liigi ootsüste, mida on nõrgestatud, et need ei põhjustaks haigust.
In a field study involving 4 farms, shedding of oocysts in the faeces was reduced within 3 weeks of vaccination both in Evalon vaccinated chicks and those vaccinated with another vaccine against Eimeria.
4 farmis toimunud väliuuringus vähenes ootsüstide eritumine väljaheitega 3 nädala jooksul pärast vaktsineerimist nii Evaloniga vaktsineeritud tibudel kui ka neil, keda vaktsineeriti Eimeria vastase muu vaktsiiniga.
Other information about Evalon?
Muu teave Evaloni kohta
When Evalon is given to chickens, the animals' immune system recognises the Eimeria oocysts as foreign and makes defences against them.
Kui kanadele manustatakse Evaloni, peab linnu immuunsüsteem Eimeria ootsüste võõraks ja tekitab nende vastu antikehi.
Evalon is available as a suspension and solvent and can only be obtained with a prescription.
Evaloni turustatakse suspensiooni ja lahustina ning see on retseptivaktsiin.
What are the risks associated with Evalon?
Mis riskid Evaloniga kaasnevad?
Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Nakatunud linnud eritavad haiguse spoore (ootsüste) väljaheitega, mis võib levitada nakkust.
The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Vaktsiin sisaldab parasiitide Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix ja Eimeria tenella elusaid atenueeritud (nõrgestatud) ootsüste.
Safety information has been included in the summary of product characteristics and the package leaflet for Evalon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati Evaloni ohutusteave, kus on ka tervishoiuspetsialistide ja loomaomanike või -pidajate võetavad meetmed.
For practical information about using Evalon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Kui loomaomanikud või -pidajad vajavad Evaloni kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
The European Commission granted a marketing authorisation valid throughout the EU for Evalon on
Euroopa Komisjon andis Evalonile müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 18/04/2016.
There are no known side effects with Evalon.
Evalonil puuduvad teadaolevad kõrvaltoimed.
How does Evalon work?
Kuidas Evalon toimib?
Evalon avian coccidiosis vaccine (live)
Evalon lindude koktsidioosi elusvaktsiin
How is Evalon used?
Kuidas Evaloni kasutatakse?
What benefits of Evalon have been shown in studies?
Milles seisneb uuringute põhjal Evaloni kasulikkus?
The vaccine is given to one-day-old chicks by coarse spray vaccination.
Vaktsiini manustatakse ühepäevastele tibudele jämespreina.
The birds consume the vaccine when preening their feathers.
Linnud manustavad vaktsiini sulgede puhastamisel.
Pharmaceutical Form
Tugevus Ravimvorm Manustamistee
Immediate Packaging Pack size blister (PVC/PVDC-Alu); wallet blister (PVC/PVDC-AluAlu); carton
Õhukese polümeerikattega tabletid blister (PVC/PVDCAlu); blistritasku blister (PVC/PVDCAlu); karp
It is given once a day by slow infusion lasting about one hour.
Ravimit manustatakse üks kord ööpäevas ligikaudu tund aega kestva aeglase infusioonina.
In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the patient's height and weight).
12-kuuste kuni 17-aastaste patsientide annus sõltub kehapindalast (arvutatakse patsiendi pikkuse ja kaalu alusel).
The full EPAR and risk management plan summary for Caspofungin Accord 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 Caspofungin Accordi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In adults, treatment begins with a 70mg starting dose, followed by a daily dose of 50 mg, or of 70 mg if the patient weighs more than 80 kg. A lower dose is given to adults who have moderate problems with their liver.
Täiskasvanutel algab ravi 70 mg algannusega, millele järgneb ööpäevane annus 50 mg või 70 mg, kui patsient kaalub üle 80 kg.
Caspofungin Accord should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Caspofungin Accordi kasutamisel alla 12-kuustel lastel peab olema ettevaatlik, sest selles vanuserühmas ei ole ravimit piisavalt uuritud.
A risk management plan has been developed to ensure that Caspofungin Accord is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada Caspofungin Accordi võimalikult ohutu kasutamine.
What measures are being taken to ensure the safe and effective use of Caspofungin Accord?
Mis meetmed võetakse, et tagada Caspofungin Accordi ohutu ja efektiivne kasutamine?
The company provided data from the published literature on caspofungin.
Ettevõte esitas kaspofungiini kohta avaldatud kirjandusest pärinevad andmed.
The Committee recommended that Caspofungin Accord be approved for use in the EU.
Komitee soovitas Caspofungin Accordi kasutamise Euroopa Liidus heaks kiita.
Caspofungin Accord caspofungin
Caspofungin Accord kaspofungiin
Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children with:
Caspofungin Accord on seenevastane ravim, millega ravitakse täiskasvanuid, noorukeid ja lapsi, kellel esineb:
Because Caspofungin Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Et Caspofungin Accord on geneeriline ravim, peetakse tema kasulikkust ja riske samasuguseks nagu võrdlusravimil.
No additional studies in humans were needed as Caspofungin Accord is a generic medicine that is given by infusion and contains the same active substance as Cancidas.
Lisauuringuid ei olnud vaja, sest Caspofungin Accord on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui Cancidas.
Caspofungin Accord must be made up into a concentrated solution and then diluted before use, using a diluent that does not contain glucose.
Caspofungin Accordist tuleb enne kasutamist valmistada kontsentreeritud lahus, kasutades lahjendit, mis ei sisalda glükoosi.
• invasive candidiasis (a type of fungal infection due to Candida);
• invasiivne kandidoos (mikroseene Candida põhjustatud seennakkuse liik);
• invasive aspergillosis (another type of fungal infection due to Aspergillus) when the infection does not respond to or the patient does not tolerate amphotericin B or itraconazole (other antifungal medicines);
• invasiivne aspergilloos (mikroseene Aspergillus põhjustatud seennakkuse liik) patsientidel, kellel amfoteritsiin B ja/või itrakonasool (teised seenevastased ravimid) on ebaefektiivsed või esineb nende suhtes talumatus;
This means that Caspofungin Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cancidas.
See tähendab, et Caspofungin Accord on sarnane võrdlusravimiga Cancidas, millel juba on Euroopa Liidus müügiluba.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Caspofungin Accord has been shown to be comparable to Cancidas.
Inimravimite komitee järeldas, et Euroopa Liidu nõuete kohaselt on tõendatud ravimi Caspofungin Accord sarnane toime ravimiga Cancidas.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Caspofungin Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Selle alusel lisati Caspofungin Accordi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
It is not intended to provide practical advice on how to use Caspofungin Accord.
Hindamisaruandes ei anta Caspofungin Accordi kasutamise praktilisi nõuandeid.
For practical information about using Caspofungin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate Caspofungin Accordi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
• suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile
• seennakkuse kahtlus (näiteks mikroseene Candida või Aspergillus põhjustatud), kui patsiendil on palavik ja neutropeenia (vere valgeliblede vähesus).
What is Caspofungin Accord and what is it used for?
Mis on Caspofungin Accord ja milleks seda kasutatakse?
Caspofungin Accord is a ‘generic medicine'.
Caspofungin Accord on geneeriline ravim.
Fungal cells treated with Caspofungin Accord have incomplete or defective cell walls, making them fragile, unable to grow and causing their death.
Caspofungin Accordi mõjul ei teki seenerakul täielikku või tervet membraani, mille tõttu on rakud haprad ja ei saa kasvada.
It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to survive and grow.
Selle toime seisneb seene eluks ja kasvamiseks vajaliku rakumembraani komponendi glükaanpolüsahhariidi tootmise takistamises.
For more information about treatment with Caspofungin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Caspofungin Accordiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
Therefore, the CHMP's view was that, as for Cancidas, the benefit outweighs the identified risk.
Seetõttu on inimravimite komitee arvamusel, et nagu Cancidasi korral, ületab ka ravimi Caspofungin Accord kasulikkus sellega kaasnevad riskid.
Other information about Caspofungin Accord
Muu teave Caspofungin Accordi kohta
This is a summary of the European public assessment report (EPAR) for Caspofungin Accord.
See on ravimi Caspofungin Accord Euroopa avaliku hindamisaruande kokkuvõte.
Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein.
Caspofungin Accord on infusioonilahuse (veeni tilgutatava lahuse) pulber.
It contains the active substance caspofungin.
Ravim sisaldab toimeainena kaspofungiini.
Why is Caspofungin Accord approved?
Miks Caspofungin Accord heaks kiideti?
The list of fungi against which Caspofungin Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Caspofungin Accordi suhtes tundlike seente loetelu on ravimi omaduste kokkuvõttes (samuti Euroopa avaliku hindamisaruande osa).
How has Caspofungin Accord been studied?
Kuidas Caspofungin Accordi uuriti?
How does Caspofungin Accord work?
Kuidas Caspofungin Accord toimib?
The active substance in Caspofungin Accord, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Caspofungin Accordis sisalduv toimeaine kaspofungiin kuulub seenevastaste ravimite ehhinokandiinide rühma.
How is Caspofungin Accord used?
Kuidas Caspofungin Accordi kasutatakse?
Caspofungin Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Ravi peab alustama invasiivsete seeninfektsioonide ravis kogenud arst.
What are the benefits and risks of Caspofungin Accord?
Milles seisneb Caspofungin Accordi kasulikkus ja mis riskid ravimiga kaasnevad?
2.5 ml (suspension) 2.5 ml (emulsion)
2,5 ml (suspensioon) 2,5 ml (emulsioon)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline
Prepandeemiline gripiviiruse vaktsiin (H5N1) (inaktiveeritud purustatud viirus, adjuveeritud) GlaxoSmithKlin e Biologicals
50 vials (suspension) 2 x 25 vials (emulsion)
50 viaali (suspensioon) 2 x 25 viaali (emulsioon)
Strength Pharmaceutical Form
Tugevus Ravimvorm Manustamiste e
Intramuscular use suspension (H5N1): vial (glass) emulsion (adjuvant): vial (glass)
Suspensioon (H5N1): viaal (klaas) Emulsioon (adjuvant): viaal (klaas)
Biologicals
Lihasesisene manustamine
3.75 µg HA Suspension and Emulsion for emulsion for injection
Suspensioon ja emulsioon süsteemulsiooni valmistamiseks
RAS-acting agents include angiotensinconverting enzyme inhibitors (ACE-inhibitors) such as benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril), angiotensin receptor blockers (ARBs) such as candesartan, telmisartan, valsartan, irbesartan, eprosartan, olmesartan, losartan and azilsartan and direct renin inhibitors such as aliskiren.
RAS-ile toimivate ainete hulka kuuluvad angiotensiinkonvertaasi (ACE) inhibiitorid, nagu benasepriil, kaptopriil, tsilasapriil, delapriil, fosinopriil, imidapriil, lisinopriil, moeksipriil, perindopriil, kvinapriil, ramipriil, spirapriil, trandolapriil ja zofenopriil, angiotensiini retseptori blokaatorid (ARB-d), nagu kandesartaan, telmisartaan, valsartaan, irbesartaan, eprosartaan, olmesartaan, losartaan ja asilsartaan, ning reniini inhibiitorid, nagu aliskireen.
This is of particular concern, as these patients and patients with renal impaired are already particularly prone to developing hyperkalaemia.
See on suur probleem, sest nendel patsientidel ja neerupuudulikkusega patsientidel võib hüperkaleemia kergemini tekkida.
In addition, the metaanalysis suggested that using multiple RAS-acting agents may not be more beneficial than using a single RAS-acting agent in terms of reducing overall mortality.
Lisaks viitas metaanalüüs sellele, et mitme RAS-ile toimiva aine kasutamine ei pruugi üldise suremuse vähendamisel olla kasulikum kui ühe RAS-ile toimiva aine kasutamine.
The PRAC was also of the opinion that the contraindication based on the ALTITUDE5 study data regarding the concomitant use of ACEinhibitors or ARBs with aliskiren-containing products in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) < 60 ml/min/1.73 m2) was confirmed by the additional data reviewed and that it should also be implemented in the product information of ARBs and ACE-inhibitors.
Ravimiohutuse riskihindamise nõuandekomitee oli ka arvamusel, et uuringu ALTITUDE5 vastunäidustuse andmeid ACE-inhibiitorite või ARB-de samaaegse kasutamise kohta koos aliskireeni sisaldavate ravimitega suhkurtõvega või neerupuudulikkusega patsientidel (glomerulaarfiltratsiooni kiirus (GFR) < 60 ml/min / 1,73 m2) kinnitasid läbivaadatud lisaandmed ning see teave tuleb lisada ka ARB-de ja ACE-inhibiitorite ravimiteabesse.