FrancophonIA/ELRC3.0 huggingface dataset:
English: The percentages of patients with clinically meaningful improvements in TDI focal score (defined as an increase of at least 1 unit) were higher with Duaklir Genuair than with placebo in ACLIFORM-COPD (64.8% compared to 45.5%; p<0.001) and AUGMENT (58.1% compared to 36.6%; p<0.0001).
Estonian: TDI fookusskoori kliiniliselt olulise paranemisega (määratletakse tõusuna vähemalt 1 ühiku võrra) patsientide osakaal oli uuringus ACLIFORM-COPD (64,8% võrreldes 45,5%-ga, p < 0,001) ja uuringus AUGMENT (58,1% võrreldes 36,6%-ga; p < 0,0001) Duaklir Genuair´i kasutamisel suurem kui platseebo korral.
English: Duaklir Genuair is not indicated for the treatment of acute episodes of bronchospasm.
Estonian: Mitte kasutada haiguse ägenemisel Duaklir Genuair ei ole mõeldud kasutamiseks bronhospasmi ägedate episoodide korral.
English: The percentage of patients in AUGMENT who achieved a clinically meaningful improvement from baseline in SGRQ total score (defined as a decrease of at least 4 units) was higher with Duaklir Genuair than with placebo (58.2% compared to 38.7%, respectively; p<0.001).
Estonian: Uuringus AUGMENT oli SGRQ koguskoori kliiniliselt olulise paranemise (määratletud vähenemisena vähemalt 4 ühiku võrra) ravieelse tasemega võrreldes saavutanud patsientide osakaal Duaklir Genuair´i kasutamisel suurem kui platseebo puhul (vastavalt 58,2% võrreldes 38,7%-ga, p < 0,001).
English: Dry mouth has been observed with medicines like Duaklir Genuair.
Estonian: Duaklir Genuair´i sarnaste ravimite puhul on täheldatud suukuivust.
English: No clinically significant effects of Duaklir Genuair on cardiac rhythm were observed on 24-hour Holter monitoring in a subset of 551 patients, of whom 114 received Duaklir Genuair twice daily.
Estonian: Lisaks ei täheldatud pärast 551 patsiendist koosnevas alamrühmas, kellest 114 sai kaks korda päevas Duaklir Genuair´i, tehtud 24-tunnises Holter-monitooringus Duaklir Genuair´i kliiniliselt olulisi toimeid südame rütmile.
English: What Duaklir Genuair is used for
Estonian: Milleks Duaklir Genuair´i kasutatakse
English: In clinical studies, paradoxical bronchospasm was not observed with Duaklir Genuair at its recommended dose.
Estonian: Kliinilistes uuringutes Duaklir Genuair´i kasutamisel soovitatud annuses paradoksaalset bronhospasmi ei täheldatud.
English: What Duaklir Genuair is
Estonian: Mis on Duaklir Genuair
English: There is limited evidence on the management of overdose with Duaklir Genuair.
Estonian: Duaklir Genuair´i üleannustamise kohta on tõendeid piiratud hulgal.
English: Duaklir Genuair reduced the use of rescue medication over 6 months compared to placebo (by 0.9 puffs per day [p<0.0001]), aclidinium (by 0.4 puffs/day [p<0.001]) and formoterol (by 0.2 puffs/day [p=0.062]).
Estonian: Duaklir Genuair vähendas esmaabiravimi kasutamist 6 kuu vältel võrreldes platseeboga (0,9 inhalatsiooni võrra ööpäevas [p<0,0001]), võrreldes aklidiiniumiga (0,4 inhalatsiooni võrra ööpäevas [p<0,001]) ja võrreldes formoterooliga (0,2 inhalatsiooni võrra ööpäevas [p<0,062]).
English: This section contains information on how to use your Genuair inhaler.
Estonian: See lõik sisaldab Duaklir Genuair´i inhalaatori kasutusteavet.
English: For inhalation use.
Estonian: Manustamisviis Inhaleerimiseks.
English: A total of 1222 patients were treated with Duaklir Genuair 340 micrograms /12 micrograms.
Estonian: Duaklir Genuair 340 mikrogrammi / 12 mikrogrammi ravi said kokku 1222 patsienti.
English: Duaklir Genuair should be discontinued in case of overdose.
Estonian: Üleannustamise korral tuleb Duaklir Genuair´i kasutamine katkestada.
English: Manufacturer: Industrias Farmacéuticas Almirall, S.A.
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutava tootja nimi ja aadress Industrias Farmacéuticas Almirall, S.L.
English: Duaklir Genuair provided a clinically meaningful improvement in disease-specific health status (as assessed by the St. George's Respiratory Questionnaire [SGRQ]) in study AUGMENT, with an improvement in the SGRQ total score compared to placebo of -4.35 units (p<0.0001).
Estonian: Questionnaire,SGRQ]) uuringus AUGMENT, kuna SGRQ järgi paranes koguskoor platseeboga võrreldes -4,35 ühiku võrra (p < 0,0001).
English: Duaklir Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Estonian: Duaklir Genuair 340 μg/12 μg inhalatsioonipulber aklidiinium/formoteroolfumaraatdihüdraat
English: No clinically relevant effects of Duaklir Genuair on ECG parameters (including QT-interval) compared with aclidinium, formoterol and placebo were seen in Phase III studies of 6 to 12 months duration conducted in approximately 4,000 patients with COPD.
Estonian: 6 kuni 12 kuud kestnud III faasi kliinilistes uuringutes, mis viidi läbi umbes 4000 KOK-patsiendil, ei tuvastatud Duaklir Genuair´i kliiniliselt olulist toimet EKG näitajatele (sh QT-intervallile) võrreldes aklidiiniumi, formoterooli ja platseeboga.
English: Duaklir Genuair 340 micrograms/12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Estonian: Duaklir Genuair 340 mikrogrammi / 12 mikrogrammi inhalatsioonipulber aklidiinium/formoteroolfumaraatdihüdraat
English: Duaklir Genuair 340 micrograms /12 micrograms inhalation powder aclidinium/formoterol fumarate dihydrate
Estonian: Duaklir Genuair 340 mikrogrammi/12 mikrogrammi inhalatsioonipulber aklidiinium/formoteroolfumaraatdihüdraat
English: You should not use Duaklir Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.
Estonian: Kui olete rase või imetate, ei tohi te Duaklir Genuair´i arsti ettekirjutuseta kasutada.
English: How to store Duaklir Genuair
Estonian: Kuidas Duaklir Genuair´i säilitada
English: Stop taking Duaklir Genuair and seek medical help immediately if you experience any of the following:
Estonian: Lõpetage Duaklir Genuair´i kasutamine ja otsige otsekohe arstiabi, kui teil esineb järgmist: - Kui teil tekib kohe pärast ravimi kasutamist äkiline pitsitustunne rinnus, köha, vilistav hingamine või hingeldus.
English: What Duaklir Genuair is and what it is used for 2.
Estonian: 1. Mis ravim on Duaklir Genuair ja milleks seda kasutatakse 2. Mida on vaja teada enne Duaklir Genuair´i kasutamist 3.
English: How to use Duaklir Genuair
Estonian: Kuidas Duaklir Genuair´i kasutada
English: Milk: 5 days.
Estonian: Piimale: 5 päeva.
English: ATC vet code: QJ51FF90
Estonian: ATCvet kood: QJ51FF90
English: The excipients listed in section 6.1 of the SPC are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Estonian: Abiained, mis on loetletud ravimi omaduste kokkuvõtte lõigus 6.1 on Määruse (EÜ) nr 470/2009 reguleerimisalasse mittekuuluvateks, kui neid kasutatakse nii nagu selles veterinaarravimis.
English: Avoid contact with the solution.
Estonian: Vältida kontakti lahusega.
English: Gram-positive isolates with an MIC > 2 µg/ml are to be considered resistant.
Estonian: Gram-positiivseid isolaate, mille MIC>2 µg/ml, loetakse resistentseteks.
English: Pirlimycin has a basic pKa (8.5).
Estonian: Pirlimütsiinil on aluseline pKa (8,5).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2001
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA PIKENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 29/01/2001
English: BATCH NUMBER Lot{number}
Estonian: PARTII NUMBER Lot: {number}
English: The following instructions should therefore be followed carefully.
Estonian: Järgida hoolikalt järgnevat juhendit.
English: Date of last renewal: 08/02/2006
Estonian: Müügiloa viimase uuendamise kuupäev: 08/02/2006
English: This means it will be more active in an acid environment and tends to concentrate, relative to plasma, in areas with lower pH, such as abscesses.
Estonian: See tähendab, et aine on aktiivsem happelises keskkonnas ja kipub plasmast sõltuvalt kontsentreeruma madalama pH-ga kohtades, nagu näiteks abstsessid.
English: Insertion: Remove the white end cap by pulling straight up.
Estonian: Manustamine: Eemaldada valge otsik tõmmates seda otse üles.
English: After intramammary infusion, mean parent concentrations in milk were 10.3 µg/ml at 12 hours and 0.77 µg/ml at 24 hours.
Estonian: Pärast intramammaarset manustamist olid keskmised algaine kontsentratsioonid piimas 10,3 µg/ml 12 tunni pärast ja 0,77 µg/ml 24 tunni pärast.
English: The active substance in Pirsue 5mg/ml intramammary solution for cattle is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Estonian: Toimeaine preparaadi Pirsue 5 mg/ml intramammaarne lahus veistele on Komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 kirjeldatud lubatud aine:
English: Meat and offal: 23 days.
Estonian: Lihale ja söödavatele kudedele: 23 päeva.
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Estonian: TOOTJAPOOLNE PARTII NUMBER Partii nr: {number}
English: The product is indicated for use in lactating dairy cows and can be used during pregnancy.
Estonian: Preparaat on mõeldud kasutamiseks lakteerivatel lehmadel ja selle kasutamine tiinuse ajal on lubatud.
English: Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval.
Estonian: Sarnased kontsentratsioonid saavutati 12 ja 24 tundi pärast teistkordset manustamist, kahe manustamistsükli vaheline intervall oli 24 tundi.
English: Of the dose infused, 10-13% is excreted in the urine, and 24-30% via the faeces; the remainder is excreted in the milk.
Estonian: Manustatud doosist väljutati 10-13 % uriiniga, 24-30% roojaga, ülejäänud piimaga.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril kuni 25°C.
English: Pirlimycin hydrochloride is a semi-synthetic lincosamide antibiotic.
Estonian: Pirlimütsiin hüdrokloriid on poolsünteetiline linkoosamiid antibiootikum.
English: Keep the syringes in the original container.
Estonian: Süstlaid hoida originaalpakendis.
English: Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Estonian: Võib esineda ristresistentsust pirlimütsiini ja teiste linkosamiidide või makroliididega.
English: The teat end should be cleaned until no more dirt appears on the swab.
Estonian: Nisaotsa tuleb puhastada, kuni lapile enam mustust ei jää.
English: Antiinfectious agents/ Antibiotics
Estonian: Infektsioonivast ased ained/ Antibiootikumi d
English: The treatment consists of eight infusions of one syringe every 24 hours.
Estonian: Ravi koosneb kaheksast manustamisest, üks süstlatäis iga kord, iga 24 tunni järel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {label on the syringe}
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: Pirlimycin
Estonian: Pirlimütsiin
English: Ensure adequate cleansing of the teat (and udder - if needed) before infusion.
Estonian: Tagada nisa (ja vajadusel udara) puhtus enne manustamist.
English: Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of Staphylococcus aureus was not demonstrated.
Estonian: On selgunud, et pirlimütsiin akumuleerub polümorfnukleaarsetes rakkudes, kuid Staphylococcus aureuse intratsellulalarset hävitamist ei täheldatud.
English: Any unused veterinary medical product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
Estonian: Kasutamata veterinaarravim või selle jäätmed tuleb hävitada vastavalt kohalikule seadusandlusele.
English: Do not treat cows with palpable udder changes due to chronic subclinical mastitis.
Estonian: Mitte kasutada lehmadel, kelle on kroonilisest subkliinilisest mastiidist tekkinud palpeeritavad muutused udaras.
English: 1000 µg/kg
Estonian: 1000 μg/kg
English: Resistance against pirlimycin.
Estonian: Resistentsus pirlimütsiinile.
English: Susceptibility testing of the target bacteria should be carried out prior to treatment.
Estonian: Enne ravimi kasutamist tuleks teha bakterite antibiootikumitundlikkuse uuring.
English: Pharmacotherapeutic group: Antibacterial for intramammary use.
Estonian: FARMAKOLOOGILISED OMADUSED Farmakoterapeutiline rühm: antibakteriaalne aine intramammaarseks manustamiseks.
English: Liver Kidney Milk
Estonian: Lihas Rasv Maks Neer Piim
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Estonian: A. RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAVAD TOOTJAD B. TARNIMIS - JA KASUTAMISTINGIMUSED VÕI PIIRANGUD C. RAVIMJÄÄKIDE PIIRNORMID
English: Infuse one syringe (50 mg pirlimycin) into each infected quarter.
Estonian: Sisesta üks süstlatäis (50 mg pirlimütsiini) igasse nakatunud udaraveerandisse.
English: Wash hands and any exposed skin with soap and water and remove contaminated clothing immediately after use.
Estonian: Pesta käed ja ravimiga kokku puutunud nahk seebi ja veega ning eemaldada ravimiga kokku puutunud riided kohe pärast kasutamist.
English: Where necessary, wash teats thoroughly with warm water containing a suitable dairy cleansing agent and dry them thoroughly.
Estonian: Vajadusel pesta nisad hoolikalt sobivat puhastusvahendit sisaldava sooja veega ja kuivata hoolikalt.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and the container.
Estonian: Ärge kasutage veterinaarravimit pärast kõlblikkusaega, mis on märgitud kõlblikkusaja lõppu mitte kasutada.
English: Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.
Estonian: Soolebakterid nagu E.coli on pirlimütsiinile resistentsed.
English: Push plunger with continuous pressure gently and slowly to dispense entire contents into the gland and massage the quarter to distribute the product into the milk cistern.
Estonian: Vajuta kolvile ühtlase survega, õrnalt ja aeglaselt, et viia kogu sisu nisasse ja masseeri udaraveerandit, et jaotada ravim udaraurkesse.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml
Estonian: VETERINAARRAVIMI NIMETUS Pirsue 5 mg/ml
English: Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Estonian: Vältida patogeenide sattumist nisassse, et vähendada E.coli infektsiooni ohtu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 8 x 10 ml syringes in an outer carton box 24 x 10 ml syringes in an outer carton box, including 3 package inserts 120 x 10 ml syringes in a plastic bucket, including 15 package inserts
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 8 x 10 süstalt välimises pappkarbis 24 x 10 süstalt pappkarbis, sisaldab 3 pakendi infolehte 120 x 10 süstalt plastikämbris, sisaldab 15 pakendi infolehte
English: TARGET SPECIES Cattle (lactating dairy cows)
Estonian: LOOMALIIGID Veis (lakteerivad lehmad).
English: Flush eyes with water for 15 minutes immediately after exposure.
Estonian: Ravimi sattumisel silma loputadasilmi koheselt veega 15 minuti jooksul.Loputamise ajal hoida silmad lahti.
English: PHARMACEUTICAL FORM Intramammary solution
Estonian: RAVIMVORM Intramammaarne lahus
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: A. RAVIMIPARTII VABASTAMISE EEST VASTUTAVAD TOOTJA
English: Do not touch cleaned teat ends before administering the infusion substance.
Estonian: Mitte puutuda puhastatud nisaotsi enne ravimi manustamist.
English: Treatment of infections due to Gram-negative bacteria such as E. coli.
Estonian: Gramnegatiivsete bakterite nagu näiteks E.coli põhjustatud haiguste ravi.
English: For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Estonian: Pirlimütsiinile tundlike grampositiivset bakteritet, sealhulgas stafülokokkide nagu Staphylococcus aureus, nii penitsilinaas-positiivsete kui penitsilinaas-negatiivsete ja koagulaas-negatiivsete bakterite; streptokokkide, sealhulgas Streptococcus agalactiae, Streptococcus dysgalactiae ja Streptococcus uberis põhjustatud subkliiniliste mastiitide ravi lakteerivatel lehmadel.
English: Intramammary use.
Estonian: Intramammaarseks manustamiseks.
English: PACKAGE SIZE 8 x 10 ml intramammary syringes 24 x 10 ml intramammary syringes 120 x 10 ml intramammary syringes
Estonian: PAKENDI SUURUS(ED) 8 x 10 ml udarasüstlad 24 x 10 ml udarasüstlad 120 x 10 ml udarasüstlad
English: Gently insert the cannula into the teat canal; carefully infuse the product.
Estonian: Viia kanüül õrnalt nisakanalisse ja sisestada ravim ettevaatlikult.
English: Wash the udder if it is dirty.
Estonian: Kui udar on määrdunud, pesta see puhtaks.
English: Use a separate disinfectant towelette for each teat.
Estonian: Iga nisa jaoks kasutada eraldi desinfitseerimispadjakest.
English: Pirlimycin Bovine 100 µg/kg 100 µg/kg
Estonian: Pirlimütsiin Veis 100 μg/kg 100 μg/kg
English: Clean hands before handling the cow's udder.
Estonian: Enne udara käsitsemist puhasta käed.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/027/001-003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/00/027/001-003
English: Following infusion, dip all teats with a disinfectant teat dip.
Estonian: Pärast manustamist desinfitseerida kõik nisad nisakastutusvahendiga.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/027/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/00/027/001
English: Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe For the full list of excipients see Section 6.1
Estonian: 10 ml süstal sisaldab 50 mg pirlimütsiini pirlimütsiin-hüdrokloriidina Abiainete täielik loetelu on esitatud lõigus 6.1.
English: Administration: by intramammary infusion only.
Estonian: Manustada ainult intramammaarselt.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 50 mg Pirlimycin
Estonian: TOIMEAINE(TE) KOGUS 50 mg pirlimütsiini
English: They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.
Estonian: Linkoosamiidid (klindamütsiin, linkomütsiin ja pirlimütsiin) inhibeerivad proteiini sünteesi gram-positiivsetes bakterites ja anaeroobsetes bakterites ning Mycoplasma spp.-s. Nad toimivad seostudes ribosoomi 50S alaühikuga, raskendades sellega aminoatsüül-tRNA seostumist ja inhibeerides peptidüültransferaasi reaktsiooni, takistades sel moel bakteri proteiinisünteesi.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pirsue 5 mg/ml intramammary solution for cattle
Estonian: VETERINAARRAVIMI NIMETUS Pirsue 5 mg/ml intramammaarne lahus veistele
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramammary use
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISVIIS(ID) JA -MEETOD Intramammaarseks manustamiseks.
English: PACKAGE LEAFLET: Pirsue 5 mg/ml intramammary solution for cattle
Estonian: PAKENDI INFOLEHT Pirsue 5 mg/ml intramammaarne lahus veistele
English: No data on overdosing are available.
Estonian: Andmed puuduvad.
English: WITHDRAWAL PERIOD(S) Withdrawal period(s):
Estonian: Keeluaeg (-ajad)
English: STATEMENT OF ACTIVE SUBSTANCES Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS 10 ml süstal sisaldab 50 mg pirlimütsiini pirlimütsiin-hüdrokloriidina
English: Muscle Fat
Estonian: Veevaba sidrunhape
English: 400 µg/kg
Estonian: 400 μg/kg 100 μg/kg
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Estonian: TOIMEAINE(TE) SISALDUS 10 ml süstal sisaldab 50 mg pirlimütsiini pirlimütsiin-hüdrokloriidina
English: Disinfect teat end using a suitable cleansing agent.
Estonian: Desinfitseerida nisaots sobiva vahendiga.
English: None known
Estonian: SISSEK ANNET EI OLE
English: MRLs
Estonian: Süstevesi
English: 6.5 Nature and composition of immediate packaging Sterile aqueous solution in 10 ml polyethylene intramammary syringes, packaged as 8 x 10 ml, 24 x 10 ml in an outer cardboard box.
Estonian: Steriilne vesilahus 10 ml polüetüleenist udarasüstaldes, 8 või 24 süstalt pappakarbis või 120 süstalt plastikämbris.
English: Sodium citrate
Estonian: Naatriumtsitraat
English: EU (MA)Number
Estonian: EL (ML) number
English: Tablet
Estonian: Tugevus
English: --1 Porcine circovirus type 2 ORF2 protein RP 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Estonian: --1 Sigade tsirkoviiruse tüüp 2 ORF2 valk suhteline tugevus 1,0 -3,75 * Suhteline tugevus (ELISA testi põhjal), võrreldes referentsvaktsiiniga
English: Content
Estonian: Sisaldus
English: Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm Manustamistee Sispekendi iseloomustus
English: Pack size l t o r
Estonian: 30 mg Süstelahuse pulber ja lahusti
English: The marketing authorisation was renewed on 22 August
Estonian: Müügiluba pikendati 22. augustil 2007.
English: Neupopeg is not recommended for use in children, due to a lack of information on its safety and effectiveness in this group.
Estonian: Neupopegi ei soovitata kasutada lastel, sest ohutuse ja efektiivsuse andmed selle rühma kohta puuduvad.
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Estonian: Filgrastiimi on Euroopa Liidus turustatud muude ravimite koostisainena mitmeid aastaid.
English: The Committee recommended that Neupopeg be given marketing authorisation.
Estonian: Komitee soovitas anda Neupopegile müügiloa.
English: The replacement acts in same way as naturally produced G-CSF.
Estonian: Tehislik G-CSF toimib samuti kui loomulikul teel tekkiv G-CSF.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEUPOPEG EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE NEUPOPEG Kokkuvõte üldsusele
English: Neupopeg has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Estonian: Neupopegi uuriti kahes põhiuuringus, kus osales 467 rinnavähiga patsienti, kes said tsütotokslilist keemiaravi.
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
Estonian: Mõlemas uuringus oli patsientidel esimese keemiaravi tsükli jooksul raske neutropeenia ligikaudu 1,7 päeva.
English: The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Estonian: Efektiivsuse peamine näitaja oli raske neutropeenia kestus keemiaravi esimese tsükli jooksul.
English: Neupopeg is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Estonian: Neupopegi manustatakse 6 mg ühekordse nahaaluse süstina ligikaudu 24 tundi pärast keemiaravi iga tsükli lõppu.
English: Most of the side effects seen in patients taking Neupopeg in studies are due to their underlying disease or chemotherapy.
Estonian: Enamik kõrvalnähtudest, mis esinesid uuringutel Neupopegi saanud patsientidel, tulenesid nende haigusest või keemiaravist.
English: It consists of filgrastim, a copy of a human protein called granulocyte colony stimulating factor (G-CSF), which has been ‘pegylated' (coated with a chemical called polyethylene glycol).
Estonian: See koosneb filgrastiimist - inimvalgu koopiast, mida nimetatakse granülotsüütide kolooniat stimuleerivaks faktoriks (G-CSF), - mis on pegileeritud (kaetud keemilise aine polüetüleenglükooliga).
English: It is available in a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim.
Estonian: Seda turustatakse eeltäidetud süstlas ja eeltäidetud pensüstelis (SureClick), millest mõlemad sisaldavad 6 mg pegfilgrastiimi.
English: Neupopeg is used in cancer patients to help with some of the side effects of their treatment.
Estonian: Neupopegi kasutatakse vähktõvega patsientidel, et anda abi nende ravi mõnede kõrvaltoimete vastu.