FrancophonIA/ELRC3.0 huggingface dataset:
English: In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Estonian: Sigadel võivad pärast vaktsineerimist esineda mööduvad paiksed süstekoha reaktsioonid, milleks peamiselt on tihke, soe ja mõnikord valulik paistetus (diameetriga kuni 10 cm).
English: Immediate systemic hypersensitivitylike reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Estonian: Vahetult pärast vaktsineerimist võivad tekkida süsteemsed ülitundlikkusesarnased reaktsioonid, mille tulemusena tekivad kerged neuroloogilised sümptomid, nagu näiteks värin ja/või erutus, mis tavaliselt ei vaja ravi ja mööduvad mõne minuti jooksul.
English: Some piglets may be depressed and show a reduced feed intake for up to 5 days.
Estonian: Mõned põrsad võivad kuni 5 päeva jooksul olla loiud ning vähem süüa.
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Estonian: Juhuslik (enese-)süstimine võib tekitada tugevat valu ja turset, eriti kui ravimit süstiti liigesesse või sõrme, ning harvadel juhtudel võib see meditsiiniabi viibimisel põhjustada kahjustatud sõrme kaotust.
English: Porcilis PCV contains mineral oil.
Estonian: Porcilis PCV sisaldab mineraalõli.
English: PCV2 associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Estonian: PCV2-ga seotud infektsioonide hulka võivad kuuluda sellised tunnused, nagu kaalulangus või kasvupeetus, suurenenud lümfisõlmed, hingamisraskus, kõhulahtisus, kahvatu nahk ja naha muutumine kollaseks.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PCV EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE PORCILIS PCV Kokkuvõte üldsusele
English: The vaccine does not contain any live PCV2.
Estonian: Vaktsiin ei sisalda PCV2 elusviirust.
English: This helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Estonian: See aitab vähendada viiruse hulka looma veres ja lümfikudedes ja vähendada nuumaperioodil PCV2-infektsiooniga seostatavat kaalulangust.
English: Through this the immune system will be able to react more quickly when it is exposed to the virus.
Estonian: Seega on immuunsüsteem võimeline kiiremini reageerima kui loom puudub viirusega hiljem uuesti kokku.
English: Information on the prescription status of this product may be found on the outer package.
Estonian: Teave selle kohta, kas toode on retseptiravim, on esitatud välispakendil.
English: Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD).
Estonian: Sigade tsirkoviiruse tüüp 2 (PCV2) on tuntud kui mitmesuguste sündroomide tekitaja sigadel, mida koos nimetatakse sigade tsirkoviiruse tüübiga 2 seotud haigusteks.
English: Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection.
Estonian: Porcilis PCVd kasutatakse vähemalt kolme päeva vanuste sigade vaktsineerimiseks PCV2infektsiooni vastu.
English: Porcilis PCV has been studied in pigs in a number of trials.
Estonian: Porcilis PCVd on sigadel uuritud mitmetes uuringutes.
English: The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Estonian: Uuringud näitasid, et sigade vaktsineerimine Porcilis PCVga aitab vähendada viiruse hulka looma veres ja lümfikudedes ning nuumaperioodil vähendada PCV2-infektsiooniga seostatavat kaalulangust.
English: Porcilis PCV contains small amounts of a protein from PCV2.
Estonian: Porcilis PCV sisaldab väikest kogust PCV2 valku.
English: Porcilis PCV is a vaccine.
Estonian: Porcilis PCV on vaktsiin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009.
Estonian: Euroopa Komisjon andis Porcilis PCV müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Intervet International B.V.
English: Other information about Porcilis PCV:
Estonian: Muu teave Porcilis PCV kohta
English: When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Estonian: Kui seale antakse vaktsiini, peab sea immuunsüsteem valku võõraks ja tekitab sellele immuunvastuse.
English: It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2).
Estonian: See sisaldab sigade tsirkoviiruse tüüp 2 (PCV2) valku (antigeeni).
English: These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems.
Estonian: Porcilis PCVd on uuritud nii laboritingimustes kui ka seakasvatuse tavatingimustes eri tootmissüsteemides.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et Porcilis PCV kasulikkus selle kasutamisel vähemalt kolme päeva vanuste sigade aktiivseks immuniseerimiseks PCV2 vastu on suurem kui sellega kaasnevad riskid.
English: What is the risk associated with Porcilis PCV?
Estonian: Mis riskid Porcilis PCVga kaasnevad?
English: What is Porcilis PCV?
Estonian: Mis on Porcilis PCV?
English: Why has Porcilis PCV been approved?
Estonian: Miks Porcilis PCV heaks kiideti?
English: Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection.
Estonian: Porcilis PCV on vaktsiin sigadele, mida turustatakse süsteemulsioonina.
English: monitored included weight gain, mortality as well as faecal and nasal shedding.
Estonian: Jälgiti efektiivsuse näitajaid, nagu kehakaalu tõus ja suremus, kuid ka viiruse eritumine roojaga ja
English: How does Porcilis PCV work?
Estonian: Kuidas Porcilis PCV toimib?
English: What is Porcilis PCV used for?
Estonian: Milleks Porcilis PCVd kasutatakse?
English: How has Porcilis PCV been studied?
Estonian: Kuidas Porcilis PCVd uuriti?
English: What benefit has Porcilis PCV shown during the studies?
Estonian: Milles seisneb uuringute põhjal Porcilis PCV kasulikkus?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamistee
English: EU/1/15/1022/001
Estonian: EU/1/15/1022/001 Unituxin
English: 3.5 mg/ml Concentrate for solution for infusion
Estonian: 3,5 mg/ml Infusioonilahuse kontsentraat
English: Intravenous use Vial (glass)
Estonian: Intravenoosne Viaal (klaasist) 5 ml
English: This summary was last updated in April 2013.
Estonian: Kokkuvõtte viimane uuendus: aprill 2013.
English: This will help to protect against the disease.
Estonian: See aitab kaitsta loomi haiguse eest.
English: The duration of protection was 12 months after primary vaccination as well as after the yearly single booster vaccination.
Estonian: Viirusevastase kaitse kestis 12 kuud pärast esmast vaktsineerimist ja pärast igaaastast ühekordset korduvvaktsineerimist.
English: The effectiveness of Equilis West Nile was first studied in a number of laboratory studies that examined how long it took to achieve protection after vaccination, and how long the protection lasted.
Estonian: Vaktsiini Equilis West Nile efektiivsust uuriti kõigepealt mitme laboratoorse katsega, mille käigus selgitati välja, kui kaua aega kulub pärast vaktsineerimist viirusevastase kaitse tekkimiseks ja kaua kaitse kestab.
English: The laboratory studies showed that horses developed protection two weeks after primary vaccination.
Estonian: Laboratoorsed katsed näitasid, et hobustel tekkis viirusevastane kaitse kaks nädalat pärast esmast vaktsineerimist.
English: A slight increase in body temperature, by up to 1.5 °C, may occur for one or two days.
Estonian: Ühe või kahe päeva vältel võib esineda ka vähene kehatemperatuuri tõus kuni 1,5 °C võrra.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha või piima toiduks tarvitada.
English: The first involved 128 pregnant mares of mixed breeds and the second involved 41 pregnant thoroughbred mares.
Estonian: Esimesse uuringusse võeti 128 tiinet segaverelist mära ja teise uuringusse 41 tiinet tõupuhast mära.
English: The first of these involved 173 horses at least six months of age, in which vaccination with Equilis West Nile was compared with a placebo (dummy injection).
Estonian: Esimene uuring hõlmas 173 vähemalt kuue kuu vanust hobust ja selles võrreldi vaktsiini Equilis West Nile platseeboga (näiva vaktsiini süst).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis West Nile on 6 June 2013.
Estonian: Euroopa Komisjon andis vaktsiini Equilis West Nile müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 06/06/2013.
English: The vaccine was also compared with placebo in two other field studies involving pregnant mares.
Estonian: Vaktsiini võrreldi platseeboga ka kahes ülejäänud väliuuringus tiinetel märadel.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis West Nile exceed the risks for the treatment of the approved indication and recommended that Equilis West Nile be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et vaktsiini Equilis West Nile kasulikkus heakskiidetud näidustusel on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: After this a single injection should be given each year as a booster.
Estonian: Seejärel tehakse üks kord aastas korduvvaktsineerimine ühe lihasesisese süstina.
English: If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Estonian: Vaktsiini eksikombel süstimisel iseendale tuleb kohe pöörduda arsti poole ja näidata arstile vaktsiini pakendi infolehte või etiketti.
English: The studies in pregnant mares showed that 89% of the vaccinated mixed-breed mares and 95% of the vaccinated thoroughbred mares produced protective antibody levels.
Estonian: Tiinetel märadel tehtud uuringud näitasid, et kaitsev antikehade hulk tekkis 89%-l vaktsineeritud segaverelistest märadest ja 95%-l vaktsineeritud tõupuhastest märadest.
English: Equilis West Nile contains an adjuvant to enhance the immune response.
Estonian: Equilis West Nile sisaldab parema immuunvastuse saamiseks ka adjuvanti.
English: The main field study showed that vaccination with Equilis West Nile when given as recommended produced protective antibody levels in 94% of the vaccinated horses at day 42 of the study.
Estonian: Põhiline väliuuring näitas, et soovituste kohasel vaktsineerimisel vaktsiiniga Equilis West Nile tekkis 42. uuringupäevaks kaitsev antikehade hulk 94%-l vaktsineeritud hobustest.
English: Equilis West Nile contains small amounts of West Nile virus that has been inactivated (killed) so that it can no longer cause disease.
Estonian: Equilis West Nile sisaldab väikeses koguses inaktiveeritud (hävitatud) Lääne-Niiluse viirust, mis ei põhjusta enam haigestumist.
English: Equilis West Nile is a veterinary vaccine that contains inactivated (killed) West Nile virus.
Estonian: Equilis West Nile on veterinaarvaktsiin, mis sisaldab inaktiveeritud (hävitatud) Lääne-Niiluse viirust.
English: The measure of effectiveness in all the field studies was the number of horses which developed protective antibody levels against West Nile virus.
Estonian: Efektiivsuse näitaja kõigis väliuuringutes oli hobuste arv, kellel tekkis vaktsineerimise järel kaitsev antikehade hulk Lääne-Niiluse viiruse vastu.
English: In future if the animals are exposed to West Nile virus the immune system will be able to respond more quickly.
Estonian: Kui loomad puutuvad hiljem Lääne-Niiluse viirusega uuesti kokku, tekivad antikehad kiiremini.
English: Equilis West Nile is used to vaccinate horses from six months of age against West Nile virus.
Estonian: Vaktsiini Equilis West Nile kasutatakse vähemalt 6 kuu vanuste hobuste vaktsineerimiseks LääneNiiluse viiruse vastu.
English: A mild short-lived swelling may develop at the injection site which resolves in one to five days.
Estonian: Süstekohas võib tekkida kergekujuline ja lühiajaline paistetus, mis möödub ühe kuni viie päevaga.
English: Equilis West Nile was also studied in three field studies.
Estonian: Vaktsiini Equilis West Nile uuriti ka kolmes väliuuringus.
English: The vaccine is initially given to horses over six months of age as two injections into the muscle, three to five weeks apart.
Estonian: Hobuste esmasel vaktsineerimisel alates 6. elukuust tehakse kaks lihasesisest süsti, mille vahe on 3−5 nädalat.
English: When Equilis West Nile is given to horses, their immune system recognises the virus contained in the vaccine as ‘foreign' and makes antibodies to defend against it.
Estonian: Kui hobustele manustatakse vaktsiini Equilis West Nile, peab immuunsüsteem vaktsiinis sisalduvaid baktereid võõraks ja tekitab nende vastu antikehi.
English: The benefit - risk balance may be found in the scientific discussion module of this EPAR.
Estonian: Vaktsiini kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu kokkuvõttes.
English: The withdrawal period for Equilis West Nile is zero days.
Estonian: Vaktsiini Equilis West Nile keeluaja pikkus on null päeva.
English: West Nile virus is an infection that is transmitted by mosquitoes and can cause severe disease and fatal brain infections in infected horses.
Estonian: Lääne-Niiluse viirust levitavad sääsed ja see võib põhjustada nakatunud hobustel raske haiguse või isegi surmaga lõppeva ajuinfektsiooni.
English: Flavivirus strain YF-WN
Estonian: Equilis West Nile flaviviiruse tüvi YF-WN
English: It contains a strain called Yellow Fever-West Nile (YF-WN).
Estonian: Vaktsiin sisaldab viirusetüve, mida nimetatakse kollapalaviku Lääne-Niiluse tüveks (YF-WN).
English: What is Equilis West Nile?
Estonian: Mis on Equilis West Nile?
English: It is available as a suspension for injection.
Estonian: Vaktsiini turustatakse süstesuspensioonina.
English: Why has Equilis West Nile been approved?
Estonian: Miks Equilis West Nile heaks kiideti?
English: Other information about Equilis West Nile:
Estonian: Muu teave vaktsiini Equilis West Nile kohta
English: What is the risk associated with Equilis West Nile?
Estonian: Mis riskid vaktsiiniga Equilis West Nile kaasnevad?
English: How does Equilis West Nile work?
Estonian: Kuidas Equilis West Nile toimib?
English: How has Equilis West Nile been studied?
Estonian: Kuidas vaktsiini Equilis West Nile uuriti?
English: What benefit has Equilis West Nile shown during the studies?
Estonian: Milles seisneb uuringute põhjal vaktsiini Equilis West Nile kasulikkus?
English: What is Equilis West Nile used for?
Estonian: Milleks vaktsiini Equilis West Nile kasutatakse?
English: EMA/CHMP/800908/2012 EMEA/H/C/002609
Estonian: 13. detsember 2012 EMA/130441/2013 EMEA/H/C/002609
English: What is Combimarv?
Estonian: Mis on Combimarv?
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Estonian: Diabeet on haigus, mille korral organismis ei teki vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Estonian: Inimravimite komitee viitas ka probleemidele seoses ettevõtte esitatud uuringuandmetega, nagu statistikavead ja lünklikud andmed.
English: In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Estonian: Peale selle esitas ettevõte 432 diabeediga patsiendil tehtud põhiuuringu andmed, milles võrreldi ettevõtte Marvel LifeSciences kolme eelnimetatud ravimi ohutust ja efektiivsust võrdlusravimitega.
English: The failures identified were such that the data provided by the company could not be used to evaluate the marketing authorisation application.
Estonian: Kontrollkäigul leitud puudused olid nii rasked, et ettevõtte esitatud andmeid ei olnud võimalik müügiloa taotluse hindamisel kasutada.
English: While the CHMP was awaiting the company's response to the questions, it requested an inspection of the site where studies with the medicine had taken place.
Estonian: Sellal kui inimravimite komitee ootas ettevõtte vastuseid küsimustele, soovis ta kontrollida kohta, kus olid toimunud ravimi uuringud.
English: Withdrawal of the marketing authorisation application for Combimarv (human insulin)
Estonian: Müügiloa taotluse tagasivõtmise teave Combimarv (iniminsuliin)
English: In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Estonian: Kirjas, milles ettevõte teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, väljendati soovi taotlus tagasi võtta, et korrata uuringud usaldusväärse lepingulise uurimisorganisatsiooni juures ja esitada inimravimite komiteele täiendavaid andmeid.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Estonian: Taotlus võeti tagasi pärast seda, kui inimravimite komitee oli hinnanud ettevõtte esialgu esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
English: The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Estonian: Kahtluste tõttu esitatud andmete suhtes soovis inimravimite komitee kontrollida India uuringukeskust Bombay Bioresearch Centre (BBRC), kus uuringute sponsor Marvel LifeSciences oli korraldanud uuringud, ja samuti ettevõtte Ühendkuningriigi ruume.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Combimarv in clinical trials.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmise ajal ei saanud ravimit Combimarv kliinilistes uuringutes mitte ükski patsient.
English: The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Estonian: Ettevõtte Marvel LifeSciences esitas ühistaotluse ravimi Combimarv ja veel kahe teise ravimi kohta (Solumarv ja Isomarv medium, mis on samuti välja töötatud bioloogiliselt sarnaste ravimitena).
English: The insulin in Combimarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Estonian: Ravimis Combimarv sisalduvat insuliini valmistatakse rekombinant-DNA-tehnoloogia abil: insuliini toodab bakter, millele on lisatud selle teket võimaldav geen (DNA).
English: Combimarv is a medicine that contains the active substance human insulin.
Estonian: Combimarv on ravim, mis sisaldab toimeainena iniminsuliini.
English: The initial concerns related mainly to the manufacture of the medicine and whether Combimarv was sufficiently similar to its reference medicine.
Estonian: Ettevaatlikkuse peamised põhjused olid seotud ravimi tootmisega, samuti kaheldi, kas Combimarv on võrdlusravimiga piisavalt sarnane.
English: The company presented the results of studies designed to show that Combimarv is similar to its reference medicine Humulin M3 in terms of its structure, biological activity and clinical performance.
Estonian: Ettevõte esitas uuringute tulemused, mille eesmärk oli näidata, et Combimarv on oma koostise, bioloogilise toime ja kliiniliste omaduste poolest sarnane võrdlusravimiga Humulin M3.
English: Among these were results from studies that looked at how the body handles Combimarv compared with Humulin M3 and how these insulins affect blood sugar levels.
Estonian: Esitati ka uuringute andmed, milles oli hinnatud, kuidas organism töötleb Combimarvi võrreldes Humulin M3-ga ja kuidas kummagi insuliin mõjutab vere glükoosisisaldust.
English: Combimarv was developed as a biosimilar medicine.
Estonian: Combimarv töötati välja bioloogiliselt sarnase ravimina.
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Estonian: Pärast taotluse esialgset hindamist nägi komitee põhjust ettevaatlikkuseks ja oli esialgsel arvamusel, et ravimi Combimarv müügiluba ei saa anda.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Combimarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Estonian: 15. novembril 2012 teatas Marvel LifeSciences Ltd. ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Combimarv müügiloa taotlus.
English: Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Estonian: Combimarvi kavatseti kasutada selliste diabeediga patsientide raviks, kes vajavad vere glükoosisisalduse (nn veresuhkru) reguleerimiseks insuliini.
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Combimarv pidi sarnanema bioloogilise võrdlusravimiga, millel juba on Euroopa Liidus müügiluba.
English: Withdrawal of the marketing authorisation application for Combimarv (human insulin) EMA/CHMP/800908/2012
Estonian: Müügiloa taotluse tagasivõtmise teave Combimarv (iniminsuliin) EMA/130441/2013
English: Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
Estonian: Ravimit Combimarv kavatseti kasutada asendusinsuliinina, mis on väga sarnane organismis tekkiva insuliiniga.
English: The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice (GCP) and seriously questioned the reliability of the study data.
Estonian: Kontrollkäigu korraldasid Saksamaa, Rootsi ja Ühendkuningriigi ravimiametid ning selle käigus leiti hulgaliselt kriitilisi ja olulisi puudusi.
English: It was to be available as a suspension for injection.
Estonian: Seda kavatseti turustada süstesuspensioonina.
English: How is Combimarv expected to work?
Estonian: Milline on ravimi Combimarv eeldatav toime?
English: What was Combimarv expected to be used for?
Estonian: Milleks kavatseti ravimit Combimarv kasutada?
English: The reference medicine for Combimarv in this application was Humulin M3. For more information on biosimilar medicines, see the questions-and-answers document here.
Estonian: Combimarvi võrdlusravim oli kõnealuse taotluse korral Humulin M3.