natgillin/translations-raw huggingface dataset:
Around 94% of patients who received either medicine were alive 30 days after treatment.
Ligikaudu 94% kumbagi ravimit saanud patsientidest oli 30 päeva pärast ravi elus.
Metalyse tenecteplase
Metalyse tenekteplaas
The main measure of effectiveness was the number of patients who were alive 30 days after treatment.
Efektiivsuse põhinäitaja oli nende patsientide arv, kes olid 30 päeva pärast ravi elus.
Based on this and all other available data, the Committee decided that Metalyse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Sellest ja olemasolevatest andmetest lähtudes otsustas komitee, et Metalyse kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
Treatment with Metalyse should be started as soon as possible after the start of heart attack symptoms.
Ravi Metalysega tuleb alustada võimalikult kiiresti pärast südameinfarkti sümptomite ilmnemist.
The dose to be given is adjusted according to the patient's weight (see the package leaflet).
Ravimi annust kohandatakse vastavalt patsiendi kehakaalule (vt pakendi infoleht).
If treatment is necessary in these patients, facilities for resuscitating them must be readily available.
Kui sellistele patsientidele tuleb siiski ravimit anda, peavad olema käepärast elustamisvahendid.
The CHMP noted that while Metalyse was as effective as alteplase in preventing death, it caused less serious bleeding, which meant that fewer blood transfusions were required.
Inimravimite komitee märkis, et Metalyse oli surma ennetamisel sama efektiivne kui alteplaas, kuid põhjustas kergemat verejooksu, mistõttu vajadus vereülekande järele oli väiksem.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Metalyse.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
With the blood clot broken down, blood can flow more easily into the heart muscle, allowing the heart to keep working and helping to save the patient's life.
Verehüüvete lagundamine hõlbustab vere voolu südamelihasesse, parandades südame tööd ja päästes nii patsiendi elu.
For more information about treatment with Metalyse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Metalysega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
This document is a summary of the European Public Assessment Report (EPAR) for Metalyse.
See on ravimi Metalyse Euroopa avaliku hindamisaruande kokkuvõte.
It works by converting a protein in the clots called plasminogen into its active form, plasmin, which breaks down the fibrous protein holding the clot together.
See muundab verehüüvetes sisalduva proteiini plasminogeeni selle aktiivseks vormiks plasmiiniks, mis lagundab verehüübeid kooshoidvat fibriini.
Metalyse should not be used in patients who have or have had recent bleeding problems or major surgery, or have a disease which may cause bleeding (such as a past stroke or severe high blood pressure).
Metalyset ei tohi kasutada ka patsiendid, kellel on hiljuti olnud probleeme verejooksuga või kes on teinud läbi suurema kirurgilise operatsiooni või kes põevad mõnd haigust, mis võib põhjustada verejooksu (nt eelnev insult või raskekujuliselt kõrge vererõhk).
The patients were given either medicine within six hours of their symptoms appearing in addition to either aspirin or heparin.
Patsientidele anti kuue tunni jooksul pärast sümptomite ilmnemist ühte neist ravimitest (lisaks aspiriinile või hepariinile).
The most common bleedings (seen in between 1 and 10 patients in 100) are epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), ecchymosis (bleeding beneath the skin), urogenital haemorrhage (bleeding from the structures that carry urine or from the genital area), bleeding at the injection site, and bleeding at puncture site.
Sagedamad verejooksud (esinenud 1-10 patsiendil 100st) on epistaksis (ninaverejooks), seedekulgla hemorraagia (verejooks maos või sooles), ekhümoos (verevalum), kuse-suguelundite verejooks ja süstekoha verejooks.
Tenecteplase is made by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Tenekteplaasi valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud selle tekkimist võimaldav geen (DNA).
Metalyse was compared with alteplase (another medicine used to treat heart attacks) in one main study involving about 17,000 adults who were having a heart attack.
Metalyset võrreldi alteplaasiga (samuti südameinfarktiravim) põhiuuringus, milles osales 17 000 südameinfarktiga täiskasvanut.
What is the risk associated with Metalyse?
Mis riskid Metalysega kaasnevad?
Metalyse should not be used in people who have had an anaphylactic reaction (a severe, lifethreatening allergic reaction) to tenecteplase, gentamicin (an ingredient found in the medicine) or any of the other ingredients.
Metalyset ei tohi kasutada patsiendid, kel on olnud anafülaktiline reaktsioon (eluohtlik allergiline reaktsioon) tenekteplaasi, gentamütsiini või ravimi mis tahes muu koostisaine suhtes.
Metalyse is used to treat adults suspected of having an acute myocardial infarction (heart attack) within six hours of the first symptoms appearing.
Metalyset kasutatakse patsientidel, kellel kahtlustatakse ägedat südamelihaseinfarkti, kuue tunni jooksul pärast esmaste sümptomite ilmnemist.
Other information about Metalyse:
Muu teave Metalyse kohta
The most common side effect with Metalyse was haemorrhage (bleeding).
Metalyse peamine kõrvalnäht on verejooks.
Metalyse was as effective as alteplase in keeping patients alive after a heart attack.
Metalyse oli südameinfarktiga patsientide elus hoidmisel sama efektiivne kui alteplaas.
Metalyse is given once as a single injection into a vein over around 10 seconds.
Metalyset manustatakse ühekordse intravenoosse (veeni süstitava) süstina umbes 10 sekundi vältel.
For the full list of all side effects reported with Metalyse, see the package leaflet.
Metalyse kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
What is Metalyse?
Mis on Metalyse?
The active substance in Metalyse, tenecteplase, is a modified copy of the human enzyme ‘tissue plasminogen activator', which the body uses to break down clots.
Metalyse toimeaine tenekteplaas on inimensüümi koe plasminogeeni aktivaatori (trombe lahustav aine) modifitseeritud koopia.
Why has Metalyse been approved?
Miks Metalyse heaks kiideti?
In addition to Metalyse, the patient should also be treated with other medicines that are used to prevent blood clots such as aspirin and heparin.
Metalysele lisaks tuleb anda teisi verehüübeid ennetavaid ravimeid (aspiriin, hepariin).
Metalyse should be prescribed by doctors who have experience in the use of thrombolytic treatments (treatments to dissolve blood clots).
Metalyset võib määrata üksnes trombolüütilise (soonesiseseid verehüübeid lahustava) ravi alal kogenud arst.
What is Metalyse used for?
Milleks Metalyset kasutatakse?
It contains the active substance tenecteplase.
Metalyse sisaldab toimeainena tenekteplaasi.
How is Metalyse used?
Kuidas Metalyset kasutatakse?
What benefit has Metalyse shown during the studies?
Milles seisneb uuringute põhjal Metalyse kasulikkus?
How has Metalyse been studied?
Kuidas Metalyset uuriti?
Metalyse is a powder and a solvent that are made up into a solution for injection.
Metalyse on süstelahuse pulber ja lahusti.
How does Metalyse work?
Kuidas Metalyse toimib?
It is used to dissolve the blood clots that have formed inside the blood vessels supplying the heart.
Ravimit kasutatakse südame veresoontes moodustunud verehüüvete (trombide) lahustamiseks.
The medicine can only be obtained with a prescription.
Metalyse on retseptiravim.
The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan.
Müügiloa hoidja tagab, et ravimit turustatakse üksnes tervishoiu asutustele, mis vastavad riskijuhtimiskavas kirjeldatud kriteeriumidele.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Liikmesriigid peavad tagama kõikide allpool kirjeldatavate ravimi ohutu ja tõhusa kasutamise tingimuste ja piirangute täitmise.
• The handling of ChondroCelect and its preparation for the implantation
• ChondroCelecti käitlemine ja ettevalmistamine implantatsiooniks;
• The schedule of follow-up of patients
• patsiendi operatsioonijärgse uuringu ajakava;
The Marketing Authorisation Holder (MAH) shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of ChondroCelect or its components, as well as those involved in follow-up of patients treated with ChondroCelect in the Healthcare Establishment, receive training as per the educational programme described in the Risk Management Plan.
Müügiloa hoidja tagab, et enne ravimi turustamist konkreetsele tervishoiu asutusele saavad riskijuhtimiskavas kirjeldatud koolitusprogrammile vastavat koolitust kõik kirurgid ja teised tervishoiu spetsialistid, kes käitlevad või manustavad ChondroCelecti või selle koostisosi, samuti ChondroCelectiga ravitud patsientide järelraviga tegelevad isikud.
The educational programme for healthcare professionals contains the following components:
Tervishoiu spetsialistide koolitusprogramm hõlmab järgmist:
The training materials for Surgeons shall include the following key messages and components:
Kirurgide koolitusmaterjalid peavad sisaldama järgmisi põhidokumente ja koostisosi:
• The handling of the biopsy harvest
• biopsia koetüki käitlemine;
• The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
• doonorite sõeluuring patsiendi küsitluslehe ja C-hepatiidi, B-hepatiidi, HIVi ja süüfilise määramise laborianalüüside alusel;
• The implantation procedure by knee-joint arthrotomy
• implantatsiooniprotseduur põlveliigese artrotoomia abil;
• Training material for other Healthcare Professionals • Informed consent for the patients to be signed prior to the treatment with ChondroCelect
• teabel põhineva nõusoleku leht, mille patsient allkirjastab enne ravi ChondroCelectiga.
The training material for other Healthcare Professionals shall include the following key messages and components:
Tervishoiuspetsialistide koolitusmaterjalid peavad sisaldama järgmisi põhidokumente ja koostisosi:
• The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure.
millega kontrollitakse patsiendi, ravimi ja implanteerimispoole õigsust ning protseduuris kasutatava bioloogilise membraani ja fibriinliimi tüüp;
This summary was last updated in 01-2011.
Kokkuvõtte viimane uuendus: 01-2011.
The full EPAR for Prevenar can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Prevenari kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports..
The additional studies showed that Prevenar was safe and effective in children up to the age of five years.
Lisauuringud näitasid, et Prevenari kasutamine on kuni viie aasta vanustel lastel ohutu ja efektiivne.
The vaccination schedule to be used depends on the age of the child and should be based on official
Kasutatav vaktsineerimisskeem sõltub lapse vanusest ning see peab põhinema ametlikel soovitustel.
Prevenar is a vaccine.
Prevenar on vaktsiin.
Prevenar was given at two, four, six and 12 to 15 months of age.
Prevenari manustati kahe, nelja, kuue ja 12 kuni 15 kuu vanuses.
The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S.A. on 2 February 2001.
Euroopa Komisjon väljastas Prevenari müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Wyeth Lederle Vaccines S.A. 2. veebruaril 2001.
What is the risk associated with Prevenar?
Mis riskid Prevenariga kaasnevad?
In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five
Need serotüübid põhjustavad Euroopas hinnangute kohaselt ligikaudu 54-84% alla kahe aasta vanuste imikute ja laste invasiivsetest nakkustest (organismis levivad nakkused) ja ligikaudu 62-83% 2-5-aastaste laste invasiivsetest nakkustest.
The marketing authorisation is valid for
Müügiluba on tähtajatu.
Alternatively, when Prevenar is given as part of a ‘universal infant immunisation programme' (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age.
Teise võimalusena, kui Prevenari manustatakse imikute üldise immuniseerimisprogrammi raames (kui piirkonna kõiki imikuid vaktsineeritakse umbes samal ajal), võib anda kaks annust, jättes annuste vahele vähemalt kaks kuud, ning seejärel antakse tugevdav annus vanuses 11-15 kuud.
The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep.
Prevenari kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on oksendamine, kõhulahtisus, isutus, süstekoha reaktsioonid (punetus, kõvenemine, paistetus või valu), palavik, ärrituvus, uimasus ja rahutu uni.
For more information about treatment with Prevenar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Prevenariga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
These polysaccharides have been purified, then ‘conjugated' (attached) to a carrier to help them be better recognised by the immune system.
Neid polüsahhariide on puhastatud ja need on seejärel konjugeeritud (kinnitatud) kandjale, et immuunsüsteem need paremini ära tunneks.
Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).
Prevenar sisaldab S. pneumoniae eri tüüpide (serotüübid 4, 6B, 9V, 14, 18C, 19F ja 23F) polüsahhariide.
The vaccine is also ‘adsorbed' (fixed) onto an aluminium compound to stimulate a better response.
Vaktsiin on adsorbeeritud (fikseeritud) parema ravivastuse stimuleerimiseks ka alumiiniumiühendile.
Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Prevenari ei tohi kasutada lapsed, kes võivad olla streptokokivaktsiini või mis tahes muu selle ravimi koostisaine või difteeriatoksoidi (difteeriat põhjustava bakteri nõrgenenud toksiin) suhtes ülitundlikud (allergilised).
Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a
Lisauuringutes uuriti Prevenari kasutamise efektiivsust ja ohutust vanematel imikutel ja lastel ning samuti imikutel antikehade teket pärast kaheannuselist immuniseerimisskeemi ja seejärel manustatud
A third dose is recommended in the second year of life.
Kolmas annus on soovitatav manustada 2. eluaastal.
Prevenar is used to vaccinate infants and children aged between two months and five years against diseases caused by S. pneumoniae.
Prevenari kasutatakse 2-kuuliste kuni 5-aastaste imikute ja laste vaktsineerimiseks S. pneumoniae põhjustatud haiguste vastu.
The CHMP decided that Prevenar's benefits are greater than its risks and recommended that Prevenar
Inimravimite komitee otsustas, et Prevenari kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
The first dose is usually given at two months of age with an interval of at least one month between doses.
Esimene annus manustatakse tavaliselt 2 kuu vanuses, kusjuures annuste vahele jäetakse vähemalt ühekuune vahe.
During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.
Põhiuuringus esines kontrollvaktsiini saanud lastel 49 juhul S. pneumoniae serotüüpidest 4, 6B, 9V, 14, 18C, 19F ja 23F põhjustatud nakkust, võrreldes kolme juhuga Prevenariga vaktsineeritud imikutel.
The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants.
Prevenari efektiivsust S. pneumoniae põhjustatud invasiivse haiguse ennetamisel uuriti ligikaudu 38 000 imikul.
A fourth dose (booster) is recommended in the second year of life.
Neljas (tugevdav) annus on soovitatav manustada teisel eluaastal.
When a person is given the vaccine, the immune system recognises the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Kui inimesele manustatakse vaktsiini, peab immuunsüsteem vaktsiinis sisalduvaid baktereid võõraks ja tekitab nende vastu antikehi.
Vaccination should be postponed in children with a severe infection
Vaktsineerimine tuleb edasi lükata lastel, kellel on äkki tekkinud äge infektsioon ja kõrge
This is a summary of the European public assessment report (EPAR) for Prevenar.
Käesolev dokument on ravimi Prevenar Euroopa avaliku hindamisaruande kokkuvõte.
Pneumococcal saccharide conjugated vaccine, adsorbed
pneumokoki sahhariididest valmistatud adsorbeeritud ja konjugeeritud
The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.
Uuringus mõõdeti nende laste arvu, kellel tekkis 3,5-aastase uuringu jooksul S. pneumoniae põhjustatud invasiivne
What benefit has Prevenar shown during the studies?
Milles seisneb uuringute põhjal Prevenari kasulikkus?
The immune system will then be able to produce antibodies more quickly when it is exposed to the bacterium again.
Kui immuunsüsteem puutub bakteriga kokku hiljem uuesti, tekivad organismis antikehad kiiremini.
It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
See on süstesuspensioon, mis sisaldab bakteri Streptococcus pneumoniae
However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.
Siiski jõudis inimravimite komitee järeldusele, et Prevenari kasutamisel rutiinse immuniseerimisprogrammi raames, mil vaktsineeritakse enamikku imikuid, ei ole tõenäoline, et S. pneumoniae nakkuse vastase kaitse määras oleks erinevusi pärast tugevdavat annust.
Prevenar was effective in preventing S. pneumoniae invasive disease.
Prevenar ennetas efektiivselt haigestumist S. pneumoniae põhjustatud invasiivsesse haigusesse.
Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae.
Neist pooled said Prevenari ja pooled teist vaktsiini, millel puudus S. pneumoniae vastane toime.
Prevenar contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Prevenar sisaldab vähesel hulgal polüsahhariide (teatud suhkruid), mis on eraldatud bakteri S. pneumoniae kestast.
These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).
Nende haiguste hulka kuuluvad sepsis (verenakkus), meningiit (pea- ja seljaaju kelmete põletik), kopsupõletik, keskkõrvapõletik ja bakterieemia.
This helps to
See aitab kaitsta haiguse eest.
The vaccine is given by injection into the thigh muscle in infants, or into the upper arm muscle in
Vaktsiini manustatakse süstina imikutel reielihasesse ja väikelastel õlavarrelihasesse
• Children aged between 12 and 23 months need two doses, with an interval of at least two months between doses.
• 12-23-kuused lapsed vajavad kaht annust, mille vahele tuleb jätta vähemalt kahekuune vahe.
• Children aged between 24 months and five years need one single dose.
• 24 kuu kuni 5 aasta vanustele lastele manustatakse üht ühekordne annus.
• Infants aged between two and six months need three doses.
• 2-6-kuused imikud vajavad kolme annust.
• Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses.
• 7-11-kuused imikud vajavad kaht annust, mille vahele tuleb jätta vähemalt ühekuune vahe.
For the full list of all side effects reported with
Prevenari kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
S. pneumoniae, but to a lower level than the three-dose schedule.
Imikute puhul kutsus kaheannuseline immuniseerimisskeem esile S. pneumoniae vastaste antikehade tekke, kuid väiksemal määral kui kolmeannuseline skeem.
This summary was last updated in November 2017.
Kokkuvõtte viimane uuendus: november 2017.
It is given to dogs once daily on an empty stomach at least one hour before the next meal.
Seda antakse koertele korra päevas tühja kõhu peale vähemalt 1 tund enne järgmist söögikorda.
Galliprant is a veterinary medicine.
Galliprant on veterinaarravim.
The full EPAR for Galliprant can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Gallipranti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The most common side effect with Galliprant (which may affect more than 1 in 10 animals) is mild and generally short-lived vomiting.
Gallipranti kõige sagedam kõrvaltoime (võib esineda enam kui 1 loomal 10st) on kerge ja üldjuhul mööduv oksendamine.
What is Galliprant and what is it used for?
Mis on Galliprant ja milleks seda kasutatakse?
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Galliprant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Veterinaarravimite komitee järeldas, et Gallipranti kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
Why is Galliprant approved?
Miks Galliprant heaks kiideti?
It is not intended to provide practical advice on how to use Galliprant.
Hindamisaruandes ei anta Gallipranti kasutamise praktilisi nõuandeid.
Galliprant must not be given to pregnant, lactating or breeding dogs.
Gallipranti ei tohi anda tiinetele, lakteerivatele ega tõuaretuses kasutatavatele koertele.
Galliprant contains grapiprant, a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug (NSAID), of the piprant class, that works in a different way from other NSAIDs, which block a range of cyclo-oxygenase enzymes.
Galliprant sisaldab toimeainena grapipranti, mis on piprantide klassi kuuluv mittesteroidne, tsüklooksügenaasi mitteinhibeeriv põletikuvastane ravim (NSAID), mille toimemehhanism erineb teiste NSAIDide (mis blokeerivad tsüklooksügenaasi eri ensüüme) omast.