FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack sizes:
Estonian: Pakendi suurus:
English: 4.2 Indications for use, specifying the target species
Estonian: 4.2 Näidustused, määrates kindlaks vastavad loomaliigid
English: The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product.
Estonian: Enne segatud toote manustamist peab läbi vaatama vastavate Nobivaci vaktsiinide ravimiteabe.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Estonian: Näiteks võib süstekohal täheldada lokaalset turset diameetriga kuni 5 cm, mille täieliku kadumiseni võib minna üle 5 nädala.
English: Special warnings for each target species: Vaccinate healthy animals only.
Estonian: Erihoiatused iga loomaliigi kohta Vaktsineerida ainult terveid loomi.
English: Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Estonian: Enne kasutamist veenduge, et vaktsiin on toatemperatuuril (15 °C-25 °C).
English: When mixed with Nobivac vaccines containing canine parainfluenza virus at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Estonian: On tõestatud, et paragripiviirust sisaldavate Nobivaci vaktsiinidega segamine iga-aastasel revaktsineerimisel ei mõjuta süstitava koerte paragripiviiruse koostisosa põhjustatud anamnestilist reaktsiooni.
English: Shelf life after reconstitution of Nobivac vaccines according to directions: 45 mins.
Estonian: Kõlblikkusaeg pärast Nobivaci vaktsiinide lahustamist: 45 minutit.
English: A small transient swelling at the site of injection (≤ 4 cm), which can occasionally be firm and painful on palpation, has been observed very commonly in clinical studies.
Estonian: Kliinilistes uuringutes on väga sageli täheldatud süstekohal väikest mööduvat turset (≤ 4 cm), mis mõnikord võib palpatsioonil olla kõva ja valulik.
English: None.
Estonian: Ei ole.
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Estonian: - L. interrogans'i serogrupi Australis serotüüp Bratislava (tüvi As-05-073)
English: SPECIAL STORAGE PRECAUTIONS
Estonian: SÄILITAMISE ERITINGIMUSED
English: Marketing authorisation holder and manufacturer responsible for batch release:
Estonian: Müügiloa hoidja ja ja partii vabastamise eest vastutav tootja:
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Estonian: Plastkarp, milles on 1 ml viaale 5, 10, 25 või 50 Pappkarp, milles on 10 ml viaale 1
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Estonian: - L. kirschneri serogrupi Grippotyphosa serotüüp Dadas (tüvi Gr-01-005)
English: 6.2 Major incompatibilities
Estonian: 6.2 Sobimatus
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS Iga annus 1 ml sisaldab:
English: MARKETING AUTHORISATION HOLDER
Estonian: MÜÜGILOA HOIDJA NIMI
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Estonian: Inaktiveeritud Leptospira tüved: - L. interrogans'i serogrupi Canicola serotüüp Portland-vere (tüvi Ca-12-000)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILISTE TOIMEAINETE TOOTJA JA RAVIMIPARTII VABASTAMISE EEST VASTUTAV TOOTJA
English: The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Estonian: Kokku segatud vaktsiinid peavad enne subkutaanse süstimisega manustamist olema toatemperatuuril (15 °C-25 °C).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4
Estonian: VETERINAARRAVIMI NIMETUS Nobivac L4
English: Excipient:
Estonian: Abiaine:
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISTEE(D) JA -MEETOD
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) See package leaflet.
Estonian: TOIMEAINE(TE) KOGUS Vaata pakendi infolehte.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.
Estonian: Olemasolevad ohutuse ja efektiivsuse andmed näitavad, et seda vaktsiini võib manustada samal päeval, kuid mitte kokku segatuna Nobivac-i vaktsiinidega, mis sisaldavad koostisosadena Bordetella bronchiseptica't ja/või paragripiviirust intranasaalseks manustamiseks.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Estonian: B. TARNIMIS- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD Retseptiravim.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Estonian: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Estonian: Wim de Körverstraat 35 5831 AN Boxmeer HOLLAND
English: Can be used during pregnancy.
Estonian: Lubatud kasutada tiinuse ajal.
English: Vaccination scheme: Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Estonian: Baasvaktsineerimine: esmase vaktsineerimise võib teostada alates 6. kuni 9.
English: In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of crossprotection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Estonian: In vitro ja in vivo andmed mittesihtliikidel viitavad, et vaktsiin võib mingil määral anda ristkaitse L. interrogans'i serogrupi Icterohaemorrhagiae serotüübi Icterohaemorrhagiae ja L. kirschneri serogrupi Grippotyphosa serotüübi Grippotyphosa vastu.
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Estonian: - L. interrogans'i serogrupi Icterohaemorrhagiae serotüüp Copenhageni (tüvi Ic-02-001)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4 suspension for injection for dogs
Estonian: VETERINAARRAVIMI NIMETUS Nobivac L4 süstesuspensioon koertele
English: Vial of 1 ml or 10 ml
Estonian: ETIKETT 1 ml ja 10 ml viaal
English: PHARMACEUTICAL FORM Suspension for injection.
Estonian: RAVIMVORM Süstesuspensioon.
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Estonian: Pärast kahekordse vaktsiiniannuse manustamist ei täheldatud muid kõrvaltoimeid kui need, mis on mainitud punktis 4.6.
English: 4.5 Special precautions for use
Estonian: 4.5 Ettevaatusabinõud
English: PHARMACEUTICAL FORM Suspension for injection
Estonian: RAVIMVORM Süstesuspensioon
English: ADVERSE REACTIONS
Estonian: ERIHOIATUSED
English: To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
Estonian: Aktiivse immuunsuse stimuleerimiseks koertel L. interrogans'i serogrupi Canicola serotüübi Canicola, L. interrogans'i serogrupi Icterohaemorrhagiae serotüübi Copenhageni, L. interrogans'i serogrupi Australis serotüübi Bratislava ja L. kirschneri serogrupi Grippotyphosa serotüübi Bananal/Lianguang vastu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP
English: For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.
Estonian: Koerte aktiivseks immuniseerimiseks: - L. interrogans'i serogrupi Canicola serotüübi Canicola vastu vähendamaks nakatumist ja eritumist uriiniga - L. interrogans'i serogrupi Icterohaemorrhagiae serotüübi Copenhageni vastu vähendamaks nakatumist ja eritumist uriiniga - L. interrogans'i serogrupi Australis serotüübi Bratislava vastu vähendamaks nakatumist - L. kirschneri serogrupi Grippotyphosa serotüübi Bananal/Lianguang vastu vähendamaks nakatumist ja eritumist uriiniga
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD PREPARAADI VÕI NENDE JÄÄTMETE, KUI NEID TEKIB, HÄVITAMISEL
English: PACKAGE LEAFLET: Nobivac L4 suspension for injection for dogs
Estonian: PAKENDI INFOLEHT Nobivac L4 süstesuspensioon koertele
English: For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4.
Estonian: Samaaegseks kasutamiseks teiste vaktsiinidega tuleb 1 annusNobivaci vaktsiini, mis sisaldab koostisosadena koerte katkuviirust, koerte adenoviiruse tüüp 2 , koerte parvoviirust ja/või koerte paragripiviirust, lahustada 1 annuse (1 ml) vaktsiiniga Nobivac L4.
English: 4.11 Withdrawal period
Estonian: 4.11 Keeluaeg (-ajad)
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components for subcutaneous administration.
Estonian: Olemasolevad ohutuse ja efektiivsuse andmed näitavad, et seda vaktsiini võib segada ja manustada koos Nobivaci vaktsiinidega, mis sisaldavad koostisosadena koerte katkuviirust, koerte adenoviiruse tüüp 2, koerte parvoviirust ja/või koerte paragripiviirust subkutaanseks manustamiseks.
English: Cardboard box with 1 vial of 10 ml (10 doses).
Estonian: Pappkarp, milles on 10 ml (10-annuselisi) viaale 1.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Estonian: MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS” Ad us. vet.
English: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate
Estonian: Dinaatriumfosfaatdihüdraat Kaaliumdivesinikfosfaat Süstevesi
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Estonian: MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VÄLJASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Vältida juhuslikku ravimi süstimist iseendale või sattumist nahale.
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml (1 dose).
Estonian: Plastkarp, milles on 1ml (1-annuselisi) viaale 5, 10, 25 või 50 .
English: ANNEX II
Estonian: LISAINFO
English: STATEMENT OF ACTIVE SUBSTANCES Read the package leaflet before use.
Estonian: TOIMEAINE(TE) SISALDUS Enne kasutamist lugege pakendi infolehte.
English: TARGET SPECIES
Estonian: LOOMALIIGID
English: Pregnancy: Can be used during pregnancy.
Estonian: Tiinus Lubatud kasutada tiinuse ajal.
English: No adverse reactions other than those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Estonian: Üleannustamine (sümptomid, esmaabi, antidoodid) Pärast kahekordse vaktsiiniannuse manustamist ei täheldatud muid kõrvaltoimeid kui need, mis on mainitud punktis 6.
English: CONTRAINDICATIONS
Estonian: KÕRVALTOIMED
English: WITHDRAWAL PERIOD(S) Not applicable.
Estonian: KEELUAEG Ei rakendata.
English: Name and address of the manufacturer of the biological active substances
Estonian: Bioloogiliste toimeainete tootja nimi ja aadress Intervet International B.V.
English: ROUTE(S) OF ADMINISTRATION
Estonian: MANUSTAMISVIIS(ID)
English: Water for injections
Estonian: Naatriumkloriid
English: 6.1 List of excipients
Estonian: FARMATSEUTILISED ANDMED 6.1 Abiainete loetelu Tiomersaal
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Estonian: B. TARNIMIS- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD
English: Page 2/2
Estonian: Lehekülg 2/2
English: What is Spanidin?
Estonian: Mis on Spanidin?
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a license.
Estonian: Pärast komitee otsust kulub Euroopa Komisjonil müügiloa andmiseks ligikaudu kaks kuud.
English: The application was at day 194 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 194 päeva, kui ettevõte võttis taotluse tagasi.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete ravimi kliinilises uuringus või eriloaga kasutamise programmis ja vajate oma ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: The main measure of effectiveness was the number of patients who stayed in remission (with no signs of active disease) for at least two months during treatment.
Estonian: Peamiseks tõhususe näitajaks oli nende patsientide arv, kellel remissioon (aktiivsete haigusnähtude puudumine) püsis ravi ajal vähemalt kahe kuu jooksul.
English: Ref. EMEA/309003/2008
Estonian: London, 26. juuni 2008 Viide: EMEA/378418/2008
English: If left untreated, it can result in organ damage or death.
Estonian: Ravimata jääv haigus või põhjustada elundi kahjustumist või surma.
English: This causes a range of symptoms that mainly affect the airways, lungs and kidneys.
Estonian: See põhjustab mitmesuguseid sümptomeid, mis mõjutavad peamiselt hingamisteid, kopse ja neere.
English: The CHMP noted that an additional study would be necessary to overcome these concerns.
Estonian: Inimravimite komitee märkis, et kahtluste lahendamiseks oleks vaja teha täiendav uuring.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte kiri, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, on avaldatud siin.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Estonian: Esialgsete dokumentide analüüsi tulemuste põhjal koostab komitee 120. päeval küsimuste loetelu, mis saadetakse ettevõttele.
English: In addition, Spanidin was not compared with any other treatment, so it was not possible to distinguish the effects of Spanidin and of steroids.
Estonian: Lisaks ei võrreldud Spanidini ühegi teise ravimiga, seega ei olnud võimalik eristada Spanidini ja steroidide toimet.
English: Spanidin was designated as an orphan medicine on 29 March
Estonian: Spanidin nimetati harva kasutatavaks ravimiks 29. märtsil 2001.
English: What were the reasons given by the company to withdraw the application?
Estonian: Mis põhjustel ettevõte taotluse tagasi võttis?
English: On 17 June 2008, Euro Nippon Kayaku GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Spanidin, for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Estonian: 17 juunil 2008 teatas Euro Nippon Kayaku GmbH ametlikult inimravimite komiteele oma soovi võtta tagasi kliinilisele ravile allumatu Wegeneri granulomatoosiga täiskasvanud patsientide remissiooni induktsiooniks kasutada kavatsetud ravimi Spanidin müügiloa taotlus.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Estonian: Uue taotluse hindamiseks kulub inimravimite komiteel enamasti kuni 210 päeva.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that a benefit of Spanidin had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Spanidini kasulikkus ei ole küllaldaselt tõendatud ega ületa tuvastatud riske.
English: How far into the evaluation was the application when it was withdrawn?
Estonian: Millises järgus oli müügiloa taotluse hindamine, kui see tagasi võeti?
English: Spanidin is a powder that is made up into a solution for injection.
Estonian: Spanidin on pulber, millest valmistatakse süstelahus.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Estonian: Inimravimite komitee oli ettevõttele esitatud küsimuste vastused läbi vaadanud, kuid mõni küsimus oli veel lahendamata.
English: The CHMP was concerned that the main study was not sufficient to demonstrate the effectiveness of Spanidin, because of the way it was designed and carried out.
Estonian: Inimravimite komitee arvates oli probleemiks, et põhiuuringus ei näidatud piisavalt Spanidini tõhusust, sest uuring ei olnud kavandatud ja läbi viidud asjakohaselt.
English: In this disease, the immune system attacks neutrophils (a type of white blood cell), causing inflammation of small and medium-sized blood vessels and the formation of granulomas (clumps of white blood cells).
Estonian: Selle haiguse korral ründab kaitsemehhanism neutrofiile (valgeliblede liik), põhjustades väikeste ja keskmise suurusega veresoonte põletikku ning granuloomide (valgeliblekogumite) moodustumist.
English: What were the main concerns of the CHMP at that time?
Estonian: Mis olid sel ajal inimravimite komitee ettevaatlikkuse peamised põhjused?
English: What documentation did the company present to support its application to the CHMP?
Estonian: Mis dokumendid esitas ettevõte inimravimikomiteele oma taotluse toetuseks?
English: By reducing the number of lymphocytes and interfering with the way they work, Spanidin is expected to reduce the inflammation in the blood vessels that causes the symptoms of the disease.
Estonian: Vähendades lümfotsüütide arvu ja takistades ennde talitlust, alandab Spanidin eeldatavasti haiguse sümptomeid põhjustavat veresoonepõletikku.
English: Wegener's granulomatosis is a rare, auto-immune disease (a disease which is caused by the body's own defence system attacking normal tissue).
Estonian: Wegeneri granulomatoos on haruldane autoimmuunhaigus (haigus, kui organismi kaitsemehhanism ründab normaalseid kudesid).
English: International non-proprietary name (INN): gusperimus
Estonian: TEAVE MÜÜGILOA TAOTLUSE TAGASIVÕTMISE KOHTA SPANIDIN Rahvusvaheline mittekaubanduslik nimetus (INN): gusperimus
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Spanidin could not have been approved for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi inimravimite komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Spanidinile ei või anda kliinilisele ravile allumatu Wegeneri granulomatoosiga täiskasvanud patsientide remissiooni induktsioonis kasutamiseks müügiluba.
English: Spanidin was not compared with any other treatment in this study, but the patients could take corticosteroids (a group of immunosuppressive medicines) in addition to Spanidin.
Estonian: Spanidini toimet selles uuringus teiste ravimitega ei võrreldud, kuid uuringus võisid patsiendid lisaks Spanidinile saada kortikosteroide (samuti immunosupressandid).
English: The active substance in Spanidin, gusperimus, is an immunosuppressive medicine, which means that it reduces the activity of the immune system (the body's natural defences).
Estonian: Spanidini toimeaine gusperimus on immunosuppressant, mis vähendab immuunvastust (organismi loomuliku kaitsemehhanismi).
English: The CHMP was also concerned that the study included some patients for whom induction treatment was not necessary, and others who did not have the symptoms of ‘classic' Wegener's granulomatosis affecting the airways, lungs or kidneys.
Estonian: Inimravimite komitee ei olnud samuti rahul, et uuringus osalesid patsiendid, kes ei vajanud induktsiooniravi, ja patsiendid, kellel puudusid klassikalise Wegeneri granulomatoosi sümptomid, mis mõjutavad hingamisteid, kopse ja neere.
English: What was Spanidin expected to be used for?
Estonian: Milleks kavatseti Spanidini kasutada?
English: Spanidin was expected to be used to control the symptoms of Wegener's granulomatosis in patients who were not responding to other treatments.
Estonian: Spanidini kavatseti kasutada Wegeneri granulomatoosi sümptomite ohjeldamiseks patsientidel, kelle haigus ei allu ravile muude ravimitega.
English: In particular, the study included some patients who could have taken other treatments for their disease, so could not be considered to be ‘refractory'.
Estonian: Eelkõige osalesid uuringus patsiendid, kelle haiguse korral oleks võinud manustada muid ravimeid ja keda ei oleks pidanud käsitama muude ravimitega ravile allumatute patsientidena.
English: They received Spanidin for six ‘cycles', with each cycle consisting of three weeks ‘on' treatment followed by one week ‘off'.
Estonian: Spanidini anti kuue tsüklina: ravimit manustati kolme nädala jooksul, millele järgnes ühenädalane paus.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Spanidin.
Estonian: Ettevõte teatas inimravimikomiteele, et praegu Spanidini kliinilistes uuringutes või erilaoga kasutamise programmides osalevatele patsientidele tagasivõtmine mõju ei avalda.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Spanidin?
Estonian: Kuidas mõjutab taotluse tagasivõtmine praegu Spanidini kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: This study would need to involve patients who are truly refractory to other treatments, or it would need to compare Spanidin directly with cyclophosphamide (the standard treatment for inducing remission in Wegener's granulomatosis).
Estonian: Selles peaksid osalema patsiendid, kelle haigus tõepoolest ei allu ravile teiste ravimitega, või tuleks uuringus võrrelda Spanidini toimet Wegeneri granulomatoosi remissiooni induktsiooniks kasutatava standardravimi tsüklofosfamiidi toimega.
English: Spanidin has been studied in one main study involving 45 patients with Wegener's granulomatosis who were ‘refractory' (not responding) to standard treatment.
Estonian: Spanidini uuriti ühes uuringus, milles osales 45 Wegeneri granulomatoosiga patsienti, kelle haigus ei allunud ravile standardsete ravimitega.
English: How is Spanidin expected to work?
Estonian: Milline on Spanidini eeldatav toime?
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Estonian: enne otsuse tegemist esitada 180. päeval täiendavaid küsimusi.
English: The effects of Spanidin were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Spanidini toimet muude katsetega.
English: It contains the active substance gusperimus.
Estonian: Ravimi toimeaine on gusperimus.