FrancophonIA/ELRC3.0 huggingface dataset:
English: The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Estonian: Onbrez Breezhaler inhalaator võimaldab kapslis sisalduvat ravimit sisse hingata.
English: Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse.
Estonian: Kui KOKi sümptomid (hingeldus, vilisev hingamine, köha) ei parane või süvenevad, rääkige sellest otsekohe oma arstile.
English: Onbrez Breezhaler inhaler
Estonian: Onbrez Breezhaler inhalaator
English: Onbrez Breezhaler is used to make breathing easier for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD).
Estonian: Onbrez Breezhaler'it kasutatakse hingamise kergemaks muutmiseks kroonilisest obstruktiivsest kopsuhaigusest (KOK) tingitud hingamisraskustega täiskasvanutel.
English: Never wash the Onbrez Breezhaler inhaler with water.
Estonian: Ärge kunagi peske Onbrez Breezhaler inhalaatorit veega.
English: Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Estonian: Karbis on 30 kapslit ja üks Onbrez Breezhaler inhalaator.
English: What Onbrez Breezhaler is and what it is used for
Estonian: Mis ravim on Onbrez Breezhaler ja milleks seda kasutatakse
English: Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Estonian: Onbrez Breezhaler on näidustatud bronhe lõõgastavaks säilitusraviks hingamisteede obstruktsiooni korral kroonilise obstruktiivse kopsuhaigusega (KOK) täiskasvanud patsientidel.
English: Talk to your doctor or pharmacist before using Onbrez Breezhaler if you have asthma (in this case you should not use Onbrez Breezhaler).
Estonian: Enne Onbrez Breezhaler'i kasutamist pidage nõu oma arsti või apteekriga: kui teil on astma (sellisel juhul ei tohi Onbrez Breezhaler'it kasutada); kui teil on probleeme südamega; kui teil on epilepsia; kui teil on probleeme kilpnäärmega (türeotoksikoos); kui teil on suhkurtõbi.
English: Carton containing 10 capsules and one Onbrez Breezhaler inhaler.
Estonian: Karbis on 10 kapslit ja üks Onbrez Breezhaler inhalaator.
English: Only use the Onbrez Breezhaler inhaler contained in this pack.
Estonian: Kasutage ainult selles pakendis sisalduvat Onbrez Breezhaler inhalaatorit.
English: The Onbrez Breezhaler inhaler enables you to inhale the medicine contained in an Onbrez Breezhaler capsule.
Estonian: Onbrez Breezhaler inhalaator võimaldab sisse hingata Onbrez Breezhaler kapslis sisalduvat ravimit.
English: When you start a new pack, use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Estonian: Kui alustate uue pakendi kasutamist, kasutage pakendis olevat uut Onbrez Breezhaler inhalaatorit.
English: You should not use Onbrez Breezhaler unless your doctor tells you so.
Estonian: Onbrez Breezhaler'it tohib kasutada ainult juhul, kui arst seda soovitab.
English: Always use the new Onbrez Breezhaler inhaler that comes with your new pack.
Estonian: Kasutage alati uut Onbrez Breezhaler inhalaatorit, mis on uues pakendis.
English: 10 capsules and 1 inhaler.
Estonian: 10 kapslit ja 1 inhalaator.
English: Onbrez Breezhaler is a single-dose inhalation device.
Estonian: Onbrez Breezhaler on inhalatsiooniseade ühekordse annuse manustamiseks.
English: During treatment with Onbrez Breezhaler,
Estonian: Ravi ajal Onbrez Breezhaler'iga
English: What Onbrez Breezhaler is used for
Estonian: Milleks Onbrez Breezhaler'it kasutatakse
English: Never place a Onbrez Breezhaler capsule directly into the mouthpiece of the Onbrez Breezhaler inhaler.
Estonian: Ärge kunagi pange Onbrez Breezhaler kapslit otse Onbrez Breezhaler inhalaatori huulikusse.
English: If you forget to inhale a dose, inhale just one dose at the usual time the next day.
Estonian: Kui te unustate Onbrez Breezhaler'it kasutada Kui te unustate annuse sisse hingamata, hingake järgmisel päeval tavalisel ajal sisse vaid üks annus.
English: Indacaterol once a day
Estonian: Indakatero ol 300 1x päevas
English: Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol.
Estonian: Iga kapsel sisaldab indakateroolmaleaati koguses, mis vastab 150 mikrogrammile indakateroolile.
English: Each inhaler should be disposed of after 30 days of use.
Estonian: Pärast 30 päevast kasutamisaega tuleb inhalaator hävitada.
English: Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol.
Estonian: Iga kapsel sisaldab indakateroolmaleaati koguses, mis vastab 300 mikrogrammile indakateroolile.
English: • When you start a new pack, only use the new Onbrez Breezhaler inhaler that is supplied in the pack.
Estonian: • Kui alustate ravimi kasutamist uuest pakendist, kasutage uut pakendis olevat Onbrez Breezhaler inhalaatorit.
English: Never take the Onbrez Breezhaler inhaler apart.
Estonian: Ärge kunagi võtke Onbrez Breezhaler inhalaatorit osadeks lahti.
English: Do not store the capsules in the Onbrez Breezhaler inhaler.
Estonian: Ärge hoidke kapsleid Onbrez Breezhaler inhalaatoris.
English: How much Onbrez Breezhaler to use
Estonian: Kui palju Onbrez Breezhaler'it kasutada
English: INSTRUCTIONS FOR USE OF ONBREZ BREEZHALER INHALER
Estonian: ONBREZ BREEZHALER INHALAATORI KASUTUSJUHEND
English: Do not swallow Onbrez Breezhaler capsules.
Estonian: Ärge neelake Onbrez Breezhaler kapsleid.
English: Common 1 Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Onbrez Breezhaler.
Estonian: Turuletulekujärgselt on teatatud Onbrez Breezhaler'i kasutamisega seotud ülitundlikkusest.
English: Some people may occasionally cough briefly soon after inhaling the medicine.
Estonian: Varsti pärast ravimi sissehingamist võib mõnel inimesel tekkida lühiajaline köha.
English: Lung function
Estonian: Kopsufunktsioon
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Estonian: Onbrez Breezhaler 150 mikrogrammi inhaleeritav pulber kõvakapslites Onbrez Breezhaler 300 mikrogrammi inhaleeritav pulber kõvakapslites indakaterool (indacaterolum)
English: How to use Onbrez Breezhaler
Estonian: Kuidas Onbrez Breezhaler'it kasutada
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Estonian: Onbrez Breezhaler 300 mikrogrammi inhaleeritav pulber kõvakapslites indacaterolum
English: 53 b 55 c
Estonian: 53 a b b c b
English: Onbrez Breezhaler 300 microgram inhalation powder, hard capsules
Estonian: Onbrez Breezhaler 300 mikrogrammi inhaleeritav pulber kõvakapslites
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules
Estonian: Onbrez Breezhaler 150 mikrogrammi inhaleeritav pulber kõvakapslites
English: How to store Onbrez Breezhaler
Estonian: Kuidas Onbrez Breezhaler'it säilitada
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Onbrez Breezhaler (i.e. medicines such as salmeterol and formoterol).
Estonian: Onbrez Breezhaler'iga sarnased ravimid (ravimid nagu salmeterool ja formoterool) hingamisprobleemide leevendamiseks.
English: Onbrez Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Estonian: Onbrez Breezhaler 150 mikrogrammi inhaleeritav pulber kõvakapslites indacaterolum
English: OUTER CARTON OF UNIT PACK
Estonian: ÜKSIKPAKENDI KARP
English: What Onbrez Breezhaler is
Estonian: Mis ravim on Onbrez Breezhaler
English: Ontruzant trastuzumab
Estonian: Ontruzant trastusumaab
English: What is Ontruzant and what is it used for?
Estonian: Mis on Ontruzant ja milleks seda kasutatakse?
English: What measures are being taken to ensure the safe and effective use of Ontruzant?
Estonian: Mis meetmed võetakse, et tagada Ontruzanti ohutu ja efektiivne kasutamine?
English: The full EPAR for Ontruzant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Ontruzanti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Ontruzant is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Ontruzant sarnaneb bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba.
English: Why is Ontruzant approved?
Estonian: Miks Ontruzant heaks kiideti?
English: The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Estonian: Infusioon võib tekitada allergilisi reaktsioone, mistõttu tuleb patsienti infusiooni ajal ja järel jälgida.
English: In addition, a study involving 875 patients with early or locally advanced breast cancer looked at the effectiveness of Ontruzant and Herceptin.
Estonian: Uuringus, milles osales 875 varases staadiumis või lokaalselt levinud rinnavähiga patsienti, uuriti Ontruzanti ja Herceptini efektiivsust.
English: It is not intended to provide practical advice on how to use Ontruzant.
Estonian: Hindamisaruandes ei anta Ontruzanti kasutamise praktilisi nõuandeid.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ontruzant has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt Euroopa Liidu nõuetele bioloogiliselt sarnaste ravimite kohta on tõendatud Ontruzanti võrreldav kvaliteet, ohutus ja efektiivsus ravimiga Herceptin.
English: Absence of invasive cancer cells was noted in the tissue removed at surgery in 52% of women given Ontruzant and 42% of those given Herceptin, but in the light of all the available information from the study this difference was not assessed to be relevant.
Estonian: Patsiente, kellelt operatsioonil eemaldatud kudedest ei leitud invasiivseid vähirakke, oli Ontruzanti kasutanud naistest 52% ja Herceptini kasutanud naistest 42%, kuid kõiki kättesaadavaid uuringuandmeid arvestades ei hinnatud seda erinevust oluliseks.
English: Ontruzant can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Estonian: Ontruzant võib põhjustada kardiotoksilisust (kahjustada südant), sealhulgas südamepuudulikkust.
English: The most common or serious side effects with Ontruzant are heart problems, reactions related to the Ontruzant infusion, reduced levels of blood cells, especially white blood cells, infections and lung problems.
Estonian: Ontruzanti kõige sagedamad või raskemad kõrvalnähud on südamehäired, Ontruzanti infusiooniga seotud reaktsioonid, vererakkude, eriti leukotsüütide (vere valgeliblede) sisalduse vähenemine, infektsioonid (nakkused) ja kopsuhäired.
English: Ontruzant can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Estonian: Ontruzant on retseptiravim ja ravi peab alustama vähiravimite kasutamises kogenud arst.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit outweighs the identified risk and Ontruzant should be given marketing authorisation.
Estonian: Seetõttu on amet arvamusel, et nagu ka Herceptini korral, ületab Ontruzanti kasulikkus sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: What are the risks associated with Ontruzant?
Estonian: Mis riskid Ontruzantiga kaasnevad?
English: How is Ontruzant used?
Estonian: Kuidas Ontruzanti kasutatakse?
English: Other information about Ontruzant
Estonian: Muu teave Ontruzanti kohta
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ontruzant have been included in the summary of product characteristics and the package leaflet.
Estonian: Ontruzanti ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: On the basis of all the data provided it was concluded that Ontruzant would behave in the same way as Herceptin in its approved indications.
Estonian: Kõigi esitatud andmete põhjal järeldati, et Ontruzant toimib heakskiidetud näidustustel samamoodi kui Herceptin.
English: The women received one or the other trastuzumab medicine before and after surgery, with other cancer medicines and radiotherapy according to standard practice.
Estonian: Naised kasutasid enne ja pärast operatsiooni üht kummastki trastusumaabi sisaldavast ravimist koos teiste vähiravimite ja kiiritusraviga vastavalt standardravile.
English: It must not be used in patients who have serious breathing problems because of advanced cancer, even when resting, or who need oxygen therapy.
Estonian: Ontruzanti ei tohi kasutada patsiendid, kellel on kaugelearenenud vähi tõttu rasked hingamisprobleemid, ka puhkeseisundis, või kes vajavad hapnikuravi.
English: Studies have also shown that giving Ontruzant produces similar levels of the active substance in the body to giving Herceptin.
Estonian: Uuringud on samuti tõendanud, et Ontruzant tekitab organismis sarnase toimeainesisalduse kui Herceptin.
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Ontruzant is used before surgery in combination with chemotherapy and then again after surgery on its own;
Estonian: Lokaalselt levinud (ka põletikuliste) või üle 2 cm suuruste kasvajate korral kasutatakse Ontruzanti enne operatsiooni koos keemiaraviga ja seejärel uuesti pärast operatsiooni ainuravimina.
English: Because Ontruzant is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Ontruzant.
Estonian: Et Ontruzant on bioloogiliselt sarnane ravim, ei pea Herceptiniga tehtud trastusumaabi efektiivsus- ja ohutusuuringuid Ontruzantiga kordama.
English: This is a summary of the European public assessment report (EPAR) for Ontruzant.
Estonian: See on ravimi Ontruzant Euroopa avaliku hindamisaruande kokkuvõte.
English: Ontruzant is a cancer medicine used to treat the following conditions:
Estonian: Ontruzant on vähiravim, mida kasutatakse järgmiste seisundite raviks.
English: The recommended dose depends on the patient's body weight and depends on the condition to be treated and whether Ontruzant is given weekly or three-weekly.
Estonian: Soovitatav annus sõltub patsiendi kehamassist, ravitavast seisundist ja sellest, kas Ontruzanti manustatakse igal nädalal või iga kolme nädala järel.
English: What benefits of Ontruzant have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Ontruzanti kasulikkus?
English: The study showed that 94% of women given Ontruzant and 93% of those given Herceptin survived without return or worsening of their disease when followed up for around 14 months.
Estonian: Uuringus oli patsiente, kes olid ligikaudu 14-kuulise järelkontrolli ajal elus ja kelle haigus ei olnud taastunud ega süvenenud, Ontruzanti kasutanud naiste seas 94% ja Herceptini kasutanud naiste seas 93%.
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5‑fluorouracil (other cancer medicines).
Estonian: • Metastaatiline maovähk - ravimit kasutatakse koos tsisplatiini ja kas kapetsitabiini või 5fluorouratsiiliga (samuti vähiravimid).
English: Ontruzant must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Estonian: Ontruzanti ei tohi kasutada patsiendid, kes on trastusumaabi, hiirevalkude või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: For more information about treatment with Ontruzant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ontruzantiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: For practical information about using Ontruzant, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Ontruzanti kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The reference medicine for Ontruzant is Herceptin.
Estonian: Ontruzanti võrdlusravim on Herceptin.
English: Laboratory studies comparing Ontruzant with Herceptin have shown that the active substance in Ontruzant is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Estonian: Ontruzanti võrreldi Herceptiniga laboriuuringutes, mis tõendasid, et Ontruzanti toimeaine sarnaneb struktuuri, puhtuse ja bioloogilise toime poolest Herceptini toimeainega.
English: The active substance in Ontruzant, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Estonian: Ontruzanti toimeaine trastusumaab on monoklonaalne antikeha (teatud valk), mis tunneb ära valgu HER2 (mille üleekspressioon esineb ligikaudu neljandiku rinnavähijuhtude ja viiendiku maovähijuhtude korral) ja seondub sellega.
English: Ontruzant can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Estonian: Ontruzanti tohib kasutada üksnes HER2 üleekspressiooniga vähi korral (kui kasvajarakkude pinnal tekib palju valku HER2, mis stimuleerib kasvajarakkude kiiret kasvu).
English: Ontruzant is a ‘biosimilar medicine'.
Estonian: Ontruzant on bioloogiliselt sarnane ravim.
English: It can also be used earlier in treatment, in combination with chemotherapy.
Estonian: Ontruzanti tohib kasutada ravis varem koos keemiaraviga.
English: How does Ontruzant work?
Estonian: Kuidas Ontruzant toimib?
English: Ontruzant contains the active substance trastuzumab.
Estonian: Ontruzanti toimeaine on trastusumaab.
English: Date of first authorisation: 25 May 2000 Date of latest renewal: 25 May 2010
Estonian: Müügiloa esmase väljastamise kuupäev: 25/05/2000 Müügiloa viimase uuendamise kuupäev: 25/05/2010
English: You must not use PegIntron if any of the conditions above should apply to you, or the child you are caring for.
Estonian: Te ei tohi kasutada PegIntron'i, kui mõni ülalnimetatud seisunditest kehtib teie või teie eestkostel oleva lapse korral.
English: - Combination of PegIntron with telbivudine.
Estonian: - PegIntron'i kombineerimine telbivudiiniga.
English: Use in adults - PegIntron alone
Estonian: Kasutamine täiskasvanutel - ainult PegIntron
English: Patients may self-inject PegIntron if their physician determines that it is appropriate and with medical follow-up as necessary.
Estonian: Patsiendid võivad endale PegIntron'i ise süstida, kui nende arst otsustab, et see on sobiv ja vastavalt vajadusele tehakse meditsiinilist järelevalvet.
English: Suicidal ideation §, suicide attempt
Estonian: Enesetapumõtted §, enesetapukatse
English: Therefore, the combination of PegIntron with telbivudine is contraindicated (see section 4.3).
Estonian: Seetõttu on PegIntron'i kombinatsioon telbivudiiniga vastunäidustatud (vt lõik 4.3).
English: Elderly (≥ 65 years of age)
Estonian: Eakad (≥ 65-aastased)
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm 3 was observed in 4 %
Estonian: Uuringus 1 (vt lõik 5.1) täheldati absoluutse neutrofiilide arvu langust madalamale kui 500 rakku/mm
English: No studies have been conducted in juvenile animals to examine the effects of treatment with PegIntron on growth, development, sexual maturation, and behaviour.
Estonian: Noorloomadel ei ole teostatud uuringuid hindamaks PegIntron-ravi toimeid kasvule, arengule, seksuaalsele küpsemisele ja käitumisele.
English: Treatment with PegIntron in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Estonian: PegIntron'i ja ribaviriini kombinatsioonravi seostati CD4+ rakkude absoluutarvu vähenemisega esimese 4 nädala jooksul ilma CD4+ rakkude protsentuaalse vähenemiseta.
English: No specific antidote for PegIntron is available; therefore, symptomatic treatment and close observation of the patient are recommended in cases of overdose.
Estonian: PegIntron'ile ei ole saadaval ühtegi spetsiifilist antidooti; seetõttu on üleannustamise juhtude korral soovitatav sümptomaatiline ravi ja patsiendi hoolikas jälgimine.
English: For disposal instructions, see section 5 “How to store PegIntron”.
Estonian: Juhiseid äraviskamiseks vt lõik 5 „Kuidas PegIntron'i säilitada“.
English: ** For patients > 120 kg, the PegIntron dose should be calculated based on the individual patient weight.
Estonian: ** Patsientidele > 120 kg tuleb PegIntron'i annus arvutada vastavalt individuaalse patsiendi kehakaalule.
English: What PegIntron looks like and contents of the pack
Estonian: Kuidas PegIntron välja näeb ja pakendi sisu
English: If you forget to take PegIntron
Estonian: Kui te unustate PegIntron'i võtta
English: Table 5 Precautions for co-administration (PegIntron should be administered with care when co-administered with the following medicines)
Estonian: Tabel 5 Ettevaatusabinõud koosmanustamisel (PegIntroni tuleb manustada ettevaatusega, kui manustatakse koos järgmiste ravimitega)
English: The potential interaction of peginterferon alfa-2b (PegIntron) on substrates of metabolic enzymes was evaluated in 3 multiple-dose clinical pharmacology studies.
Estonian: Alfa-2b-peginterferooni (PegIntron) võimalikku koostoimet metaboolsete ensüümide substraatidega hinnati kolmes mitmeannuselises kliinilise farmakoloogia uuringus.
English: Reduce only PegIntron dose (see note 2) if:
Estonian: Vähendada ainult PegIntron'i annust (vt märkus 2), kui
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with PegIntron.
Estonian: See kõrvaltoime võib tekkida erinevatel ajahetkedel ravi ajal, tavaliselt mitu kuud pärast PegIntron'iga ravi alustamist.
English: SVR % (n/N) 99 % CI
Estonian: PVR % (n/N) 99% CI
English: A large long-term follow-up study enrolled 567 patients after treatment in a prior study with PegIntron (with or without ribavirin).
Estonian: Laiaulatuslikku pikaajalisse ravijärgsesse jälgimisuuringusse kaasati 567 patsienti, kes olid eelnevas uuringus saanud PegIntron-ravi (koos ribaviriiniga või ilma).
English: PegIntron vials are for single use only.
Estonian: PegIntron'i viaalid on mõeldud ainult ühekordseks kasutamiseks.
English: When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin (Table 5).
Estonian: Kui patsientidele manustatakse PegIntroni koos CYP1A2 või CYP2D6 abil metaboliseerivate ravimitega, siis tsütokroom P 450 aktiivsuse languse määr ei oma tõenäoliselt kliinilist mõju, välja arvatud ravimite korral, millel on kitsas terapeutiline vahemik (Tabel 5).
English: Two pivotal trials have been conducted, one (C/I97-010) with PegIntron monotherapy; the other (C/I98-580) with PegIntron in combination with ribavirin.
Estonian: On läbi viidud 2 olulist uuringut: üks (C/I97-010) PegIntron'i monoteraapiaga ja teine (C/I98-580) PegIntron'i ja ribaviriini kombinatsiooniga.
English: This may require combinations of various PegIntron dose strengths and volumes.
Estonian: Vajalik võib olla erinevate PegIntron'i annuse tugevuste ja mahtude kombineerimine.
English: There are no data available regarding potential effects of PegIntron treatment on male or female fertility.
Estonian: Fertiilsus Puuduvad andmed PegIntron-ravi võimalike mõjude kohta mehe või naise fertiilsusele.
English: Do not use PegIntron
Estonian: Ärge kasutage PegIntron'i