FrancophonIA/ELRC3.0 huggingface dataset:
English: was 40 % lower when compared with patients with normal renal function (see section 4.4).
Estonian: Raske neerukahjustusega (kreatiniini kliirens alla 30 ml/min) patsientidel oli AsIII plasmakliirens 40% võrra väiksem võrreldes normaalse neerufunktsiooniga patsientidega (vt lõik 4.4).
English: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen.
Estonian: Teiste primaarsete pahaloomuliste kasvajate teke TRISENOX'i toimeaine arseentrioksiid on inimesele kartsinogeenne.
English: Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of TRISENOX.
Estonian: - Enne TRISENOX'i esimese annuse manustamist tehakse vereanalüüsid kaaliumi, magneesiumi, kaltsiumi ja kreatiniini sisalduse määramiseks.
English: Each ml of concentrate contains 2 mg of arsenic trioxide.
Estonian: Üks ml kontsentraati sisaldab 2 mg arseentrioksiidi.
English: There are no studies in pregnant women using TRISENOX.
Estonian: TRISENOX'i kasutamist rasedatel ei ole uuritud.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION TRISENOX 1 mg/ml concentrate for solution for infusion Each ml of concentrate contains 1 mg of arsenic trioxide.
Estonian: TRISENOX 1 mg/ml infusioonilahuse kontsentraat Üks ml kontsentraati sisaldab 1 mg arseentrioksiidi.
English: Patients in the ATRA + chemotherapy treatment group received IV idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then IV mitoxantrone at 10 mg/m2 on days 1
Estonian: Konsolideeriva ravi ajal said patsiendid 1. kuni 4. päeval idarubitsiini annuses 5 mg/m2 ja ATRA-t annuses 45 mg/m2 üks kord ööpäevas 15 päeva jooksul; seejärel 1. kuni 5. päeval i.v.
English: Cytogenetics after TRISENOX therapy Table 5
Estonian: Tsütogeneetika pärast ravi TRISENOX'iga
English: - If you have further questions, please ask your doctor, pharmacist or nurse.
Estonian: - Kui teil on lisaküsimusi, pidage nõu oma arsti, apteekri või meditsiiniõega.
English: What TRISENOX looks like and contents of the pack - TRISENOX is a concentrate for solution for infusion (sterile concentrate).
Estonian: - TRISENOX on infusioonilahuse kontsentraat (steriilne kontsentraat).
English: Skin and subcutaneous tissue disorders Pruritus
Estonian: Naha ja nahaaluskoe kahjustused
English: Tell your doctor or nurse straight away if you notice one or more of the following side effects, as these may be signs of allergic reaction: - difficulty in breathing - fever - sudden weight gain - water retention - fainting - palpitations (strong heartbeat you can feel in your chest)
Estonian: Rääkige oma arstile või meditsiiniõele kohe, kui teil tekib üks või mitu järgmistest kõrvaltoimetest, sest need võivad olla allergilise reaktsiooni nähud:
English: Dilution of TRISENOX
Estonian: TRISENOX'i lahjendamine
English: The daily dose can be escalated back to 100 % of the original dose if no prolongation occurs.
Estonian: Kui QTc-intervalli pikenemine ei kordu, võib suurendada ööpäevase annuse uuesti 100% algsele originaalannusele.
English: TRISENOX contains sodium
Estonian: TRISENOX sisaldab naatriumi
English: Contents of the pack and other information
Estonian: Kuidas TRISENOX'i säilitada Pakendi sisu ja muu teave
English: The following undesirable effects have been reported in the APL0406 study in newly diagnosed patients and in clinical trials and/or post-marketing experience in relapsed/refractory APL patients.
Estonian: Esmaselt diagnoositud patsientidega tehtud uuringus APL0406 ja kliinilistes uuringutes ja/või turuletulekujärgselt on teatatud retsidiividega või halvasti ravile alluva APL-iga patsientidel järgmistest kõrvaltoimetest, mis on alljärgnevalt loetletud tabelis 2 MedDRA eelisterminitena vastavalt organsüsteemi klassidele ja esinemissageduste alusel, mida täheldati TRISENOX'i kliinilistes uuringutes 52-l ravile raskesti alluva/ retsidiveeruva APL-iga patsiendil.
English: Pulmonary alveolar haemorrhage
Estonian: Kopsualveoolide hemorraagia
English: OTHER
Estonian: III
English: - fatigue (weariness), pain, fever, headache
Estonian: - hingamisraskused; - köha; - rindkerevalu; - palavik.
English: - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Estonian: Väga sage (võib esineda rohkem kui 1 inimesel 10st): - väsimus (kurnatus), valu, palavik, peavalu; - iiveldus, oksendamine, kõhulahtisus; - pearinglus, lihasvalu, tundetus või torkimine; - lööve või sügelus, vere suhkrusisalduse suurenemine, tursed (liigsest vedelikust tingitud paistetus); - õhupuudus, kiire pulss, EKG kõrvalekalded; - kaaliumi või magneesiumi sisalduse vähenemine veres, maksa- või neerufunktsiooni peegeldavate analüüside patoloogilised tulemused, sh vere liigne bilirubiinisisaldus või gamma glutamüültransferaasi aktiivsuse suurenemine veres.
English: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RARα by RT-PCR or micro speckled PML nuclear distribution in leukaemic cells were included.
Estonian: Kaasati ka esmaselt diagnoositud APL-iga patsiendid, kelle haigust kinnitas t(15;17) või RT-PCR abil tuvastatud
English: Erythema
Estonian: Kihelus
English: TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide
Estonian: TRISENOX 2 mg/ml infusioonilahuse kontsentraat Arseentrioksiid
English: Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted.
Estonian: Neerukahjustusega patsientidel oli süsteemne kokkupuude MMAV ja DMAV-ga pigem suurenenud;
English: Pleural effusion
Estonian: Vaskulaarsed häired
English: TRISENOX 1 mg/ml concentrate for solution for infusion arsenic trioxide
Estonian: TRISENOX 1 mg/ml infusioonilahuse kontsentraat Arseentrioksiid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/002
Estonian: EU/1/02/204/002
English: Arsenic is excreted in human milk.
Estonian: Arseen eritub rinnapiima.
English: Intravenous use after dilution Single use only
Estonian: Intravenoosne pärast lahjendamist Ainult ühekordseks kasutamiseks Enne ravimi kasutamist lugege pakendi infolehte.
English: If your doctor or nurse gives you more TRISENOX than he/she should You may experience convulsions, muscle weakness and confusion.
Estonian: Kui arst või meditsiiniõde manustab teile rohkem TRISENOX'i kui ette nähtud
English: Contraception in males and females
Estonian: Ainevahetus- ja toitumishäired
English: Relapsed/refractory acute promyelocytic leukaemia (APL) Induction treatment schedule
Estonian: Retsidiividega või halvasti ravile alluv äge promüelotsüütne leukeemia (APL)
English: Lymphopenia
Estonian: Pleuraefusioon
English: The total clearance of AsIII over the single-dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 l/h and the renal clearance is 9 l/h.
Estonian: (manustatuna 0,15 mg/kg) on 49 l/h ja neerukliirens on 9 l/h.
English: Ventricular tachycardia
Estonian: Ventrikulaarne tahhükardia
English: Table 1 Recommendation for initiation of hydroxyurea WBC
Estonian: Soovitused hüdroksüuureaga ravi alustamiseks Vere valgelibled
English: Dyspnoea
Estonian: Entsefalopaatia
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/001
Estonian: EU/1/02/204/001
English: Mechanism of action
Estonian: Induktsioonravi skeem
English: Oedema
Estonian: Paresteesia
English: Relapsed/refractory APL
Estonian: Retsidiividega või halvasti ravile alluv APL
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TRISENOX 1 mg/ml sterile concentrate arsenic trioxide
Estonian: Pakendi infoleht: teave patsiendile TRISENOX 1 mg/ml infusioonilahuse kontsentraat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TRISENOX 2 mg/ml sterile concentrate arsenic trioxide
Estonian: Pakendi infoleht: teave patsiendile TRISENOX 2 mg/ml infusioonilahuse kontsentraat
English: EXP
Estonian: Surmad
English: A.
Estonian: As
English: Pain
Estonian: Püreksia
English: EXPIRY DATE
Estonian: TRISENOX'i annuses
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS
English: CLINICAL PARTICULARS
Estonian: Psühhiaatrilised häired
English: At Risk
Estonian: Ohustatud
English: Renal impairment
Estonian: Febriilne neutropeenia
English: Three patients from the single institution study and 15 patients from the multicentre study had stem cell transplants after completing TRISENOX.
Estonian: TRISENOX'iga ravi lõpetamisel siirati tüvirakke kolmele patsiendile ühekeskuselisest ja 15 patsiendile mitmekeskuselisest uuringust.
English: Table 3 Endpoint
Estonian: Tabel 3
English: The treatment may be repeated every three months depending on the patient's symptoms.
Estonian: Ravi võib korrata iga kolme kuu järel, olenevalt patsiendi sümptomitest.
English: The painful area should be determined by a doctor and marked on the skin.
Estonian: Valuliku piirkonna peab määrama arst ja märkima nahale.
English: The full EPAR for Qutenza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Qutenza kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can be used alone or together with other medicines for pain.
Estonian: Seda võib kasutada ainsa ravimina või koos muude valuvaigistitega.
English: What measures are being taken to ensure the safe and effective use of Qutenza?
Estonian: Mis meetmed võetakse, et tagada Qutenza ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Qutenza is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Qutenza võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Qutenza on 15 May 2009.
Estonian: Euroopa Komisjon andis Qutenza müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. mail
English: Because of this, healthcare professionals should wear nitrile gloves while applying and removing the patch.
Estonian: Selle tõttu peavad tervishoiutöötajad kandma plaastri paigaldamisel ja eemaldamisel nitriilkindaid.
English: Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body.
Estonian: Qutenza tuleb jätta jalalabadele 30 minutiks ja teistesse nahapiirkondadesse 60 minutiks.
English: Before applying Qutenza, the area may be treated with a local anaesthetic to numb it; this helps to reduce discomfort.
Estonian: Enne Qutenza paigaldamist võib piirkonda tuimastada paikse anesteetikumiga; see aitab vähendada ebamugavustunnet.
English: Qutenza capsaicin
Estonian: Qutenza kapsaitsiin
English: Other information about Qutenza
Estonian: Muu teave Qutenza kohta
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza's benefits are greater than its risks and recommended that Qutenza be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Qutenza kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: The rapid release of high doses of capsaicin from Qutenza overstimulates the TRPV1 receptors so they become less sensitive to the stimuli that normally cause neuropathic pain.
Estonian: Suurte annuste kapsaitsiini kiire vabanemine Qutenzast stimuleerib TRPV1-retseptoreid üle ja muudab nad vähem tundlikuks stiimulitele, mis tavaliselt tekitavad neuropaatilise valu.
English: The programme will include information on how to administer, handle and dispose of Qutenza and on warnings and precautions that should be considered during treatment.
Estonian: Koolitusprogrammis käsitletakse Qutenza manustamise, käsitsemise ja kõrvaldamise teavet, samuti ravi ajal järgitavaid hoiatusi ja ettevaatusmeetmeid.
English: This is a summary of the European public assessment report (EPAR) for Qutenza.
Estonian: See on ravimi Qutenza Euroopa avaliku hindamisaruande kokkuvõte.
English: All of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection).
Estonian: Kõigil patsientidel oli neuropaatiline valu, mis tulenes kas postherpeetilisest neuralgiast (valu inimestel, kellel on olnud vöötohatis ehk tuulerõugeviiruse tekitatud teatud nakkus) või HI-viirusega seotud neuropaatiast (HI-viiruse nakkusest tingitud närvikahjustus).
English: The main measure of effectiveness in all main studies was the reduction in the 24-hour pain score during an eight- or 12-week period after application of the patch.
Estonian: Efektiivsuse põhinäitaja kõikides põhiuuringutes oli valu ööpäevase hindamise skaala punktide vähenemine 8 või 12 nädala jooksul pärast plaastri paigaldamist.
English: In addition, the company that makes Qutenza will make sure that an educational programme is available for healthcare professionals who will prescribe Qutenza.
Estonian: Lisaks tagab Qutenza tootja koolitusprogrammi tervishoiutöötajatele, kes määravad Qutenzat.
English: Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor.
Estonian: Qutenza peab paigaldama arst või arsti järelevalve all muu tervishoiutöötaja.
English: The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and redness at the site of application.
Estonian: Qutenza kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on valu ja punetus paigalduskohal.
English: For more information about treatment with Qutenza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Qutenzaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Supportive data showed benefit when Qutenza was repeated over a 1-year period in combination with other treatments.
Estonian: Toetavad andmed näitasid, et Qutenzaga ravi kordamine koos muu raviga üheaastase perioodi jooksul oli kasulik.
English: A fifth study compared Qutenza with a placebo (dummy) patch in 369 patients with painful peripheral diabetic neuropathy, a form of neuropathic pain associated with diabetes; a supportive study looked at repeated treatment over one year.
Estonian: Viiendas uuringus võrreldi Qutenzat platseeboga (näiv ravim) 369 patsiendil, kellel oli valulik diabeetiline perifeerne neuropaatia, diabeediga seostatav neuropaatilise valu vorm; toetavas uuringus vaadeldi korduvat ravi ühe aasta jooksul.
English: Once the patch is removed, the area is cleaned using the cleansing gel provided.
Estonian: Pärast plaastri eemaldamist tuleb piirkond puhastada pakendis sisalduva puhastusgeeliga.
English: Alternatively, medicines for pain may be taken.
Estonian: Alternatiivina tohib manustada valuvaigisteid.
English: Qutenza has been compared with control patches containing lower amounts of capsaicin (0.04%) in four main studies involving a total of 1,619 adults with moderate to severe neuropathic pain.
Estonian: Qutenza toimet võrreldi plaastritega, mis sisaldasid vähem kapsaitsiini (0,04%) neljas põhiuuringus, milles osales 1619 mõõduka kuni tugeva neuropaatilise valuga täiskasvanud patsienti.
English: Qutenza is used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves) in adults.
Estonian: Qutenzat kasutatakse perifeerse neuropaatilise valu (valu, mille tekitab närvikahjustus) ravimiseks täiskasvanutel.
English: No more than four patches should be used on the patient at the same time.
Estonian: Patsiendil võib olla korraga kuni neli plaastrit.
English: Qutenza can only be applied to unbroken, non-irritated, dry skin.
Estonian: Qutenzat tohib paigaldada üksnes tervele ärrituseta kuivale nahale.
English: It stimulates the ‘transient receptor potential vanilloid 1' (TRPV1) receptor which is found in the nerves in the skin that detect pain.
Estonian: See stimuleerib transientset retseptoripotentsiaali tekitavat vanilloidretseptor-1 (TRPV1), mida leidub valutundlikes nahanärvides.
English: Qutenza can cause a burning sensation on the skin.
Estonian: Qutenza võib tekitada nahal põletustunde.
English: Why has Qutenza been approved?
Estonian: Miks Qutenza heaks kiideti?
English: The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers.
Estonian: Qutenza toimeaine kapsaitsiin on tavapäraselt tšillipipras sisalduv aine.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Qutenza, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Qutenza omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Qutenza.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: It may take up to three weeks for Qutenza to have an effect.
Estonian: Qutenza hakkab mõjuma kuni kolme nädala jooksul.
English: Qutenza was more effective at reducing neuropathic pain than the control patches.
Estonian: Qutenza oli neuropaatilise valu vähendamisel võrreldud plaastritest efektiivsem.
English: What is the risk associated with Qutenza?
Estonian: Mis riskid Qutenzaga kaasnevad?
English: Qutenza is a cutaneous patch (a patch that delivers a medicine into the skin).
Estonian: Qutenza on nahaplaaster (plaaster, millest ravim imbub organismi läbi naha).
English: In the second study of patients with HIV-associated neuropathy, although Qutenza reduced pain by 30% it was not shown to be more effective than the control.
Estonian: HI-viirusega seotud neuropaatiaga patsientide teises uuringus vähendas Qutenza valu 30%, kuid ei olnud võrdlusplaastrist efektiivsem.
English: Patches can be cut to match the area to cover.
Estonian: Plaastri võib lõigata kaetava piirkonna kujuga sobivaks.
English: For the full list of all side effects and restrictions with Qutenza, see the package leaflet.
Estonian: Qutenza kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: In patients with painful peripheral diabetic neuropathy, the reduction in pain score from week 2 to after 8 weeks with Qutenza was about 27% compared with 21% for the placebo.
Estonian: Valuliku diabeetilise perifeerse neuropaatiaga patsientidel vähenesid 2 kuni 8 nädala jooksul pärast Qutenza paigaldamist valuskaala punktid 27%, samas kui platseebot saanud patsientide punktid vähenesid 21%.
English: In one of the studies of patients with HIV-associated neuropathy, patients who were given Qutenza experienced a 23% reduction in pain scores after 12 weeks compared with an 11% reduction in patients who were given the control.
Estonian: Ühes HI-viirusega seotud neuropaatiaga patsientide uuringus vähenesid Qutenzat saanud patsientide valuskaala punktid 12 nädala järel 23%, samas kui võrdlusplaastreid saanud patsientide punktid vähenesid 11%.
English: What benefit has Qutenza shown during the studies?
Estonian: Milles seisneb uuringute põhjal Qutenza kasulikkus?
English: How does Qutenza work?
Estonian: Kuidas Qutenza toimib?
English: In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches.
Estonian: Postherpeetilise neuralgiaga patsientide mõlemas uuringus vähenesid Qutenzat saanud patsientide valuskaala punktid vastavalt 30% ja 32%, samas kui võrdlusplaastreid saanud patsientide punktid vähenesid 20% ja 24%.
English: What is Qutenza used for?
Estonian: Milleks Qutenzat kasutatakse?
English: How is Qutenza used?
Estonian: Kuidas Qutenzat kasutatakse?
English: It is applied to the most painful areas of the skin.
Estonian: Qutenza paigaldatakse naha kõige valulikumale piirkonnale.
English: How has Qutenza been studied?
Estonian: Kuidas Qutenzat uuriti?
English: Other information about Refixia
Estonian: Muu teave Refixia kohta
English: The full EPAR for Refixia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Refixia kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Refixia?
Estonian: Mis meetmed võetakse, et tagada Refixia ohutu ja efektiivne kasutamine?
English: Patients or their carers may be able to inject Refixia themselves at home once they have been trained appropriately.
Estonian: Patsiendid või nende hooldajad tohivad süstida Refixiat ise kodus, kui nad on saanud asjakohase väljaõppe.
English: Since this could potentially cause problems especially in children below 12 years of age, Refixia is only approved for use in in adults and children from 12 years of age.
Estonian: Et see võib tekitada probleeme, eelkõige alla 12-aastastel lastel, kiidetakse Refixia heaks kasutamiseks üksnes täiskasvanutel ja vähemalt 12-aastastel lastel.
English: Why is Refixia approved?
Estonian: Miks Refixia heaks kiideti?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Refixia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Refixia kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What is Refixia and what is it used for?
Estonian: Mis on Refixia ja milleks seda kasutatakse?
English: It can be used in adults and children from 12 years of age.
Estonian: Ravimit tohib kasutada täiskasvanutel ja vähemalt 12-aastastel lastel.
English: In the second study in 25 children aged below 13 years, all patients were given Refixia as a weekly preventive treatment.
Estonian: Teises uuringus, milles osales 25 alla 13-aastast last, said kõik patsiendid Refixiat iganädalase ennetava ravina.
English: Hypersensitivity (allergic) reactions are uncommon with Refixia (may affect up to 1 in 100 patients) and may include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Estonian: Ülitundlikkusreaktsioonid (allergiareaktsioonid) esinevad Refixia korral aeg-ajalt (võivad esineda kuni 1 patsiendil 100st) ning need on näiteks süstekoha turse või põletus- ja torkimistunne, külmavärinad, õhetus, sügelev lööve, peavalu, nõgeslööve, madal vererõhk, letargia, iiveldus ja oksendamine, rahutus, kiirenenud südametegevus, rõhumistunne rinnus ning vilistav hingamine.
English: It is not intended to provide practical advice on how to use Refixia.
Estonian: Hindamisaruandes ei anta Refixia kasutamise praktilisi nõuandeid.
English: The dose and frequency of treatment depend on whether Refixia is used to treat or prevent bleeding, or to reduce bleeding during surgery, the extent and location of the bleeding, and the patient's bodyweight.
Estonian: Annus ja manustamissagedus sõltuvad sellest, kas Refixiat kasutatakse verejooksude ravimiseks või ennetamiseks või verejooksu vähendamiseks operatsiooni ajal, samuti verejooksu raskusest ja asukohast ning patsiendi kehakaalust.