FrancophonIA/ELRC3.0 huggingface dataset:
English: At the time of the withdrawal, the company had not demonstrated that Zioxtenzo is highly similar to Neulasta and an inspection to confirm that it was being manufactured according to GMP standards had not yet taken place.
Estonian: Taotluse tagasivõtmise ajal ei olnud ettevõte tõestanud, et Zioxtenzo on väga sarnane Neulastaga, ning ei olnud veel toimunud kontrollkäiku, mis kinnitaks, et ravimit toodetakse kooskõlas hea tootmistavaga.
English: Zioxtenzo was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Estonian: Zioxtenzot kavatseti kasutada neutropeenia kestuse ja febriilse neutropeenia (palavikuga neutropeenia) esinemissageduse vähendamiseks.
English: One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta.
Estonian: Esiteks ei tõestanud uuringutulemused, et pegfilgrastiimi kontsentratsioon veres oli pärast Zioxtenzo manustamist sama kui Neulasta korral.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
Estonian: Tuginedes esitatud andmete analüüsile, nägi komitee taotluse tagasivõtmise ajal kaht põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimit Zioxtenzo ei ole võimalik Neulastaga bioloogiliselt sarnase ravimina heaks kiita.
English: Zioxtenzo was developed as a ‘biosimilar' medicine.
Estonian: Zioxtenzo töötati välja bioloogiliselt sarnase ravimina.
English: The active substance in Zioxtenzo, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Estonian: Zioxtenzo toimeaine pegfilgrastiim koosneb pegüleeritud (polüetüleenglükooliga (PEG) kaetud) filgrastiimist.
English: Zioxtenzo was to be used in cancer patients to treat neutropenia (low levels of neutrophils, a type of white blood cell that helps fight infection).
Estonian: Zioxtenzot kavatseti kasutada vähipatsientidel neutropeenia raviks (neutrofiilide ehk teatud infektsioonivastaste valgeliblede vähesus).
English: What was Zioxtenzo expected to be used for?
Estonian: Milleks kavatseti Zioxtenzot kasutada?
English: granulocyte-colony-stimulating factor (G-CSF).
Estonian: Filgrastiim on väga sarnane inimvalguga, mida nimetatakse granülotsüütide kolooniat stimuleerivaks faktoriks (G-CSF).
English: It was to be available as a solution for injection under the skin.
Estonian: Seda kavatseti turustada subkutaanse süstelahusena.
English: The Ministerie van Landbouw, Natuurbeheer en Visserij confirmed that the manufacturing site was authorised under number 324-BVEAK for pharmaceutical products.
Estonian: Ministerie van Landbouw, Natuurbeheer en Visserij kinnitas, et tootmiskohale oli omistatud luba number 324-BVEAK farmaatsiatoodete tootmiseks.
English: 24 months.
Estonian: 24 kuud
English: SPECIAL WARNING(S), IF NECESSARY
Estonian: ERIHOIATUS(ED) KUI VAJALIK
English: Avoid contact with the product.
Estonian: Vältida otsest kontakti preparaadiga.
English: Its mineralocorticoid and progestational activity is very low.
Estonian: Tema mineralokortikoidne ja progestatsionaalne aktiivsus on väga madal.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Estonian: Wim de Körverstraat 35 5831 AN BOXMEER Holland
English: Wash hands after use.
Estonian: Pärast preparaadi kasutamist pesta käsi.
English: Pharmacotherapeutic group: Glucocorticosteroid, ATCvet code: QD07AC90.
Estonian: Farmakoterapeutiline grupp: glükokortikosteroid, ATC-vet kood: QD07AC90
English: The treatment period should not exceed 14 days.
Estonian: Ravikuur ei tohiks ületada 14 päeva.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Pruban 0.1 % cream for dogs
Estonian: VETERINAARPREPARAADI NIMETUS Pruban 0,1 % kreem koertele
English: Do not use in puppies under 6 months of age.
Estonian: Mitte kasutada alla kuue kuu vanustel kutsikatel.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/024/001
Estonian: NUMBER(NUMBRID) ÜHENDUSE RAVIMREGISTRIS EU/2/00/024/001
English: Do not store above 25 °C.
Estonian: Hoida temperatuuril kuni 25 °C.
English: During initial treatment apply the cream twice daily.
Estonian: Ravi algul manustada kreemi 2 korda päevas.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Estonian: MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS” NING TINGIMUSED VÕI PIIRANGUD TARNIMISE JA KASUTAMISE OSAS, kui need on kohaldatavad
English: Treat for 7 to 14 days.
Estonian: Ravida 7...14 päeva.
English: 4.6 Adverse reactions (frequency and seriousness) On rare occasions hyperaemia of the treated area has been observed.
Estonian: 4.6 Kõrvaltoimed (sagedus ja tõsidus) Harvadel juhtudel on täheldatud ravitavas piirkonnas hüpereemiat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s)
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Toimeaine(d):
English: The expression of these effects depends on the mode of application and the dosage applied.
Estonian: Toime väljendumine sõltub manustamisviisist ja doosist.
English: PACKAGE SIZE Tube containing 15 g of cream
Estonian: PAKENDI SUURUS Tuub sisaldab 15 g kreemi
English: ANNEX III LABELLING AND PACKAGE INSERT
Estonian: LISA III PAKENDI MÄRGISTUS JA INFOLEHT
English: D. STATEMENT OF THE MRLs Not applicable.
Estonian: D. RAVIMJÄÄKIDE PIIRNORMID Ei kohaldata.
English: Shelf-life after first opening of the tube: 8 weeks.
Estonian: Kõlblikkusaeg pärast esmast avamist: 8 nädalat.
English: Lesions should be monitored closely for signs of infection.
Estonian: Nahakahjustusi tuleb hoolikalt uurida, et avastada võimalikku infektsiooni.
English: On rare occasions hyperaemia of the treated area has been observed.
Estonian: Harvadel juhtudel on täheldatud ravitavas piirkonnas hüpereemiat.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Estonian: VETERINAARPREPARAADI NIMETUS
English: Since glucocorticosteroids can slow growth, use in young, growing animals should be well controlled and large lesions should not be treated.
Estonian: Et glükokortikosteroidid aeglustavad kasvu, siis noorte loomade ravimisel peab neid hoolikalt jälgima ning noorte koerte ulatuslikke nahakahjustusi ei tohiks antud preparaadiga ravida.
English: Special precautions for use in animals
Estonian: Ettevaatusabinõud loomadel kasutamisel
English: Overdosing, i.e. application rate of more than twice a day, or extension of the duration of treatment, increases the risk of glucocorticoid systemic effects particularly when administered on extensive lesions.
Estonian: Üledoseerimine (manustamine rohkem kui 2 korda päevas, ravikuuri pikenemine) suurendab glükokortikoidi süsteemse toime tekke ohtu, seda eriti ulatuslike nahakahjustuste ravimisel.
English: It is recommended that the animal be distracted for several minutes following treatment to prevent licking (oral absorption of the cream is not harmful to the dog, but removal of the cream by licking directly after treatment might decrease efficacy).
Estonian: Pärast ravimi manustamist on soovitav mitme minuti jooksul koera tähelepanu köita, et koer ei saaks ravitavat piirkonda lakkuda (suu kaudu organismi sattununa on ravim küll koerale ohutu, kuid ravimi äralakkumine ravitavalt piirkonnalt vähendab ravi efektiivsust).
English: Apply a 1 cm strip (0.2 g) of cream per 10 cm2 of lesion.
Estonian: 1 cm portsjon (ligikaudu 0,2 g) 10 cm2 põletikulise pinna kohta.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril kuni 25°C.
English: THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN" Keep out of reach and sight of children
Estonian: MÄRGE ”HOIDA LASTE EEST VARJATUD JA KÄTTESAAMATUS KOHAS” Hoida laste eest varjatud ja kättesaamatus kohas.
English: The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing process and secondary infections.
Estonian: Nende ainete terapeutiline kasutamine inimesel on põhjustanud lokaalseid kõrvalnähte nagu naha paksenemine, naha hapraks muutumine, pikaleveninud paranemine ja sekundaarsed nakkused.
English: This product belongs to the class of dermocorticoids.
Estonian: Preparaat kuulub dermokortikoidide rühma.
English: Resocortol butyrate has local and systemic glucocorticoid effects.
Estonian: Resokortoolbutüraadil on lokaalne ja süsteemne glükokortikoidne toime.
English: In case of diabetes mellitus, the potential systemic effects of the product may influence glycaemia.
Estonian: Diabetes mellitus'e korral võib ravim süsteemse toime tõttu mõjutada glükeemiat.
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Estonian: C. MÜÜGILOA TINGIMUSED VÕI PIIRANGUD OHUTU JA EFEKTIIVSE KASUTAMISE OSAS
English: For example, the total surface area treated of a dog weighing 5 kg should not exceed 50 cm2).
Estonian: Näiteks kui ravitava koera kaal on 5 kg, ei tohi ravitava pindala suurus ületada 50 cm2.
English: 6.3 Special precautions for storage
Estonian: 6.3 Säilitamise eritingimused
English: Do not use in animals suffering from Cushing's syndrome.
Estonian: Mitte kasutada Cushing-sündroomi korral.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only
Estonian: LAUSE “AINULT VETERINAARSEKS KASUTAMISEKS” Ainult veterinaarseks kasutamiseks.
English: Do not use in dogs with extensive lesions.
Estonian: Mitte kasutada koertel kellel on laialdased põletikud.
English: Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ulcerated lesions.
Estonian: Mitte kasutada juhtudel, kui põletikuga kaasneb bakterite, viiruste, seente ja parasiitide nakkus või haavandid..
English: After oral administration in dogs few systemic effects were observed.
Estonian: Suukaudsel manustamisel koertele avalduvad mõned süsteemsed toimed.
English: PHARMACEUTICAL FORM Cream
Estonian: RAVIMVORM Kreem
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 15 g
Estonian: PAKENDI SISU KAALU, MAHU VÕI DOOSIDE JÄRGI
English: B. PACKAGE INSERT
Estonian: B. PAKENDI INFOLEHT
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Estonian: Kasutamata veterinaarpreparaat või jäätmematerjal tuleb hävitada vastavalt kohalikule seadusandlusele.
English: Resocortol butyrate is a corticosteroid which has a high intrinsic glucocorticoid activity.
Estonian: Resokortoolbutüraat on kortikosteroid, millel on kõrge glükokorikoidne aktiivsus.
English: 4.2 Indications for use
Estonian: 4.2 Näidustused
English: INDICATION(S) Treatment of acute localised moist dermatitis.
Estonian: NÄIDUSTUS(ED) Ägedate lokaliseerunud niiskete dermatiitide ravi.
English: PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE
Estonian: MÜÜGILOA TINGIMUSED, SEALHULGAS HANKE- JA KASUTUSPIIRANGUD
English: 4.11 Withdrawal periods
Estonian: 4.11 Keeluajad
English: After topical application on the skin, a local anti-inflammatory effect is seen, which is accompanied by a moderate and reversible adrenal suppression at higher doses.
Estonian: Naha pinnale manustades võib täheldada põletikuvastast toimet koos mõõduka pöörduva adrenaalsupressiooniga suurte dooside korral.
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Estonian: TOOTMISLOA HOIDJA(D), KES VASTUTAB (VASTUTAVAD) RAVIMIPARTII VÄLJASTAMISE EEST
English: WITHDRAWAL PERIOD Not applicable
Estonian: MÜÜGILOA KEELAMINE Ei rakendata
English: 4.10 Overdose
Estonian: 4.10 Üleannustamine
English: Pruban contains the active principle resocortol butyrate.
Estonian: Pruban sisaldab toimeainena resokortoolbutüraati.
English: Treatment of acute localised moist dermatitis.
Estonian: Ägedate lokaliseerunud niiskete dermatiitide ravi.
English: PACKAGE INSERT
Estonian: PAKENDI INFOLEHT
English: Do not use in dogs used for breeding and in lactating or pregnant bitches.
Estonian: Mitte kasutada tõuaretuses kasutatavatel koertel ning tiinetel ja imetavatel koertel.
English: Once broached, use within 8 weeks
Estonian: Pärast esmast avamist 8 nädalat
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Estonian: MANUSTAMISVIIS JA -TEE(D) Välispidine.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Estonian: Ettevaatusabinõud veterinaarravimi manustajale
English: 11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Estonian: MÜÜGI-, HANKE- JA/VÕI KASUTUSKEELD
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD PREPARAADI VÕI NENDE JÄÄTMETE, KUI NEID TEKIB, HÄVITAMISEL
English: The maximum total surface of lesions (treated in cm2) should not exceed 10 times the body weight (in kg).
Estonian: Maksimaalne ravitav pindala sentimeetrites ei tohi ületada 10 korda looma kehamassi kilogrammides.
English: PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities None known.
Estonian: 6.1 Sobimatus
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS IF ANY
Estonian: ERINÕUDED KASUTAMATA JÄÄNUD RAVIMI VÕI JÄÄTMEMATERJALI HÄVITAMISEKS (KUI NEID ON)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS JA PARTII VABASTAMISE EEST
English: CONTRA-INDICATIONS
Estonian: VASTUNÄIDUSTUSED
English: Clean the affected areas and clip the hair covering the lesions before application.
Estonian: Enne ravimi manustamist puhastada ravitav piirkond ja pügada sellelt karvad.
English: The dog should be re-examined by the veterinarian, if the lesion is not cured after 14 days of treatment.
Estonian: Kui ravi ei ole andnud 14 päeva jooksul tulemusi, peab loomaarst looma uuesti põhjalikult läbi vaatama.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISTEE(D) JA -MEETOD
English: SPECIAL STORAGE PRECAUTIONS
Estonian: Erihoiatused kasutamisel
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Resocortol butyrate 1mg/g
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Pruban sisaldab aktiivse toimeainena 1 mg/g resokortool butüraati [11β,17α-dihüdroksü-21-metüülpregna-4-ene-3,20- dione-17-butüraat].
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Estonian: VÄLISPAKENDIL VÕI SELLE PUUDUMISEL SISEPAKENDIL PEAVAD OLEMA
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Estonian: B. MÜÜGILOA TINGIMUSED VÕI PIIRANGUD TARNIMISE VÕI KASUTAMISE OSAS Retseptiravim.
English: Wear disposable gloves when applying the product.
Estonian: Preparaadi manustamisel tuleb kanda ühekordselt kasutatavaid kaitsekindaid.
English: 4.8 Interaction with other veterinary medicinal products and other forms of interaction Do not apply other topical preparations concomitantly to the same lesions.
Estonian: Mitte kasutada teisi lokaalselt manustatavaid ravimeid sama kahjustuse ravimiseks.
English: WITHDRAWAL PERIOD
Estonian: KÕRVALTOIMED
English: Resocortol butyrate
Estonian: Resokortoolbutüraat
English: 6.4 Nature and composition of immediate packaging Collapsible aluminium tube containing 15 g cream, sealed with aluminium and closed with a polyethylene screw cap, packed in cardboard boxes, one tube per box.
Estonian: Üks kokkuvajutatav alumiiniumtuub, sisaldab 15 g kreemi.
English: Apply to the affected skin by gently applying it to the lesion.
Estonian: Manustada ravim ettevaatlikult kahjustatud nahale.
English: PHARMACEUTICAL FORM White to off-white cream
Estonian: RAVIMVORM Kahvatuvalge kreem
English: ROUTE(S) OF ADMINISTRATION Cutaneous use.
Estonian: MANUSTAMISTEE(D) Välispidine.
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
Estonian: TOIMEAINE(TE) JA ABIAINETE SISALDUS Resokortoolbutüraat
English: Wearing disposable gloves, apply the cream gently to the lesion.
Estonian: Manustada ravim ettevaatlikult kahjustatud nahale, kanda ühekordselt kasutatavaid kaitsekindaid.
English: BATCH NUMBER
Estonian: PARTII NUMBER PARTII:
English: 30 June 2024
Estonian: 30. juuni 2024.
English: Submission of study results:
Estonian: Uuringu tulemuste esitamine:
English: Use of this medicine during pregnancy should be avoided if possible.
Estonian: Selle ravimi kasutamist raseduse ajal tuleb võimaluse korral vältida.
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Ireland
Estonian: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Iirimaa
English: These types of symptoms occur in greater than 1 out of every 10 patients.
Estonian: Selliseid sümptomeid esineb enam kui 1 patsiendil 10-st.
English: pH: 5.0 to 6.0
Estonian: pH: 5,0…6,0
English: You will only be given this medicine if the possible benefit is greater than the possible risks.
Estonian: Teile antakse seda ravimit üksnes juhul, kui ravimi võimalik kasulikkus on suurem kui võimalikud riskid.
English: Other medicines and GIAPREZA
Estonian: Muud ravimid ja GIAPREZA
English: Osmolarity: 130 to 170 mOsm/kg
Estonian: Osmolaalsus: 130…170 mOsm/kg
English: Peripheral ischaemia
Estonian: Perifeerne isheemia
English: 38/58 patients mITT=modified intent-to-treat population
Estonian: 38 patsienti 58-st mITT = modifitseeritud ravikavatsuslik populatsioon
English: A risk to the suckling child cannot be excluded.
Estonian: Riski rinnaga toidetavale lapsele ei saa välistada.
English: The diluted solution should be used immediately.
Estonian: Lahjendatud lahus tuleb kohe ära kasutada.
English: Median age was 64 years (range: 22-89 years).
Estonian: Mediaanvanus oli 64 aastat (vahemik 22…89 aastat).
English: Overdose may result in severe hypertension.
Estonian: Üleannustamine võib põhjustada rasket hüpertensiooni.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1384/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/19/1384/001
English: Animal studies are insufficient with respect to reproductive toxicity.
Estonian: Loomkatsed on reproduktiivtoksilisuse hindamiseks ebapiisavad.
English: EXP: After dilution, use immediately.
Estonian: EXP: Pärast lahjendamist kasutada kohe.
English: Your doctor should be told if you are using, have recently used, or might use any other medicines.
Estonian: Teie arst peab teadma, kui te kasutate või olete hiljuti kasutanud või kavatsete kasutada mis tahes muid ravimeid.
English: Very common side effects (may affect more than 1 in 10 people) are: - Too high blood pressure
Estonian: Väga sagedad kõrvaltoimed (võivad esineda enam kui 1 inimesel 10-st): - liiga kõrge vererõhk.
English: GIAPREZA should not be used in children or adolescents under 18 years of age as it has not been studied in these age groups.
Estonian: GIAPREZAt ei tohi kasutada lastel ega alla 18-aastastel noorukitel, sest seda ei ole nendes vanuserühmades uuritud.
English: Diluted solution should be clear and colourless.
Estonian: Lahjendatud lahus peab olema selge ja värvitu.
English: There are no data available on the potential effects on fertility in humans.
Estonian: Andmed võimaliku mõju kohta inimese fertiilsusele puuduvad.
English: While not all of these symptoms lead to life-threatening complications, your doctor should be told about them immediately.
Estonian: Ehkki kõik need sümptomid ei pruugi põhjustada eluohtlikke tüsistusi, tuleb neist viivitamata teatada oma arstile.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja viaalil pärast märget „EXP:“ (kõlblik kuni).
English: The effect of GIAPREZA on morbidity and mortality has not been determined in appropriate studies.
Estonian: GIAPREZA toimet haigestumusele ja suremusele ei ole vastavates uuringutes kindlaks tehtud.
English: If this occurs, hospital staff will monitor your vital signs and you will be provided with supportive care.
Estonian: Sellisel juhul jälgivad haiglatöötajad teie tervisenäitajaid ning teile tagatakse toetav ravi.
English: It has not been tested in other types of shock.
Estonian: Seda ei ole uuritud muud tüüpi šokiga patsientidel.
English: Final concentration (ng/mL)
Estonian: Lõppkontsent ratsioon (ng/ml)
English: Vial strength
Estonian: Viaali tugevus
English: You will be monitored closely to make sure that your blood pressure is at the right level.
Estonian: Teid jälgitakse hoolikalt veendumaks, et teie vererõhu väärtused on õiged.
English: Your doctor will continue to assess your response and will adjust the dose accordingly up to a maximum of 80 ng per kilogram each minute during the first 3 hours of treatment.
Estonian: Teie arst hindab pidevalt ravivastust ning kohandab sellele vastavalt annust kuni maksimumannuseni 80 ng kilogrammi kohta minutis esimese 3 ravitunni jooksul.
English: 114/163 patients
Estonian: 114 patsienti 163-st
English: One patient in each arm discontinued treatment as a result.
Estonian: Mõlemas uuringurühmas katkestas selle tõttu ravi üks patsient.
English: Frequency of adverse reactions MedDRA System Organ Class Very common
Estonian: Kõrvaltoimete esinemissagedus MedDRA organsüsteemi klass Väga sage
English: Your doctor will monitor your blood pressure and adjust your dose as needed.
Estonian: Teie arst jälgib teie vererõhku ning kohandab annust vastavalt vajadusele.
English: OTHER La Jolla Pharmaceutical
Estonian: MUU La Jolla Pharmaceutical
English: 91% of subjects had septic shock; the remaining subjects had other forms of distributive shock such as neurogenic shock.
Estonian: 91%-l uuringus osalenutest oli septiline šokk, ülejäänud patsientidel oli muu verevarustushäire vorm, näiteks neurogeenne šokk.
English: The safety and efficacy of GIAPREZA in children less than 18 years old has not yet been established.
Estonian: Lapsed GIAPREZA ohutus ja efektiivsus alla 18-aastastel lastel ei ole veel tõestatud.
English: The dose depends on your body weight.
Estonian: Annus sõltub teie kehakaalust.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac stimulants, ATC code: C01CX09
Estonian: Farmakoterapeutiline rühm: südamehaiguste ravi, teised südametegevust stimuleerivad ained, ATC-kood: C01CX09.
English: Instructions for preparation of the medicinal product before administration 1.
Estonian: Ravimpreparaadi manustamiseelse ettevalmistamise juhised 1.
English: Storage conditions
Estonian: Säilitamistingimused
English: Use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the foetus.
Estonian: Raseduse ajal kasutamist tuleb võimaluse korral vältida ning võrrelda võimalikku kasu patsiendile võimaliku riskiga lootele.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/10,000 to < 1/100), rare (≥ 1/10,000
Estonian: Sagedused on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/10 000 kuni < 1/100), harv (≥ 1/10 000 kuni < 1/1000), väga harv (< 1/10 000).
English: Yes
Estonian: Jah
English: The maximum dose after the first 3 hours will be 40 ng per kilogram each minute.
Estonian: Maksimumannus pärast esimest 3 tundi on 40 ng kilogrammi kohta minutis.
English: The adverse reactions described in this section were identified in the pivotal clinical study (N = 163 treated with GIAPREZA).
Estonian: Käesolevas lõigus kirjeldatud kõrvaltoimed tehti kindlaks keskses kliinilises uuringus (N = 163 patsienti, kes kasutasid GIAPREZAt).
English: It is not known whether GIAPREZA can affect fertility.
Estonian: Ei ole teada, kas GIAPREZA mõjutab viljakust.
English: GIAPREZA will be given to you in a hospital by a doctor or a nurse.
Estonian: GIAPREZAt manustab teile haiglas arst või meditsiiniõde.