FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Injection site reactions (e.g. stinging, burning, pain , redness, oedema) Reporting of suspected adverse reactions
Estonian: Sage: süstekoha reaktsioonid (nt kipitus, kõrvetustunne, valu, punetus, ödeem) Võimalikest kõrvaltoimetest teavitamine
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe
Estonian: RAVIMPREPARAADI NIMETUS Relistor 12 mg süstelahus süstlis
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/011
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/011
English: STATEMENT OF ACTIVE SUBSTANCE Each vial of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Estonian: TOIMEAINE(TE) SISALDUS Üks 0,6 ml viaal sisaldab 12 mg metüülnaltreksoonbromiidi.
English: Constipation not related to opioid use
Estonian: Opioidide kasutamisega mitteseotud kõhukinnisus
English: Each vial contains 0.6 mL of solution for injection.
Estonian: Üks viaal sisaldab 0,6 ml süstelahust.
English: There was no significant relationship between baseline opioid dose and laxation response in methylnaltrexone bromide-treated patients in these studies.
Estonian: Neis uuringutes ei sõltunud laksatsiooniline ravivastus metüülnaltreksoonbromiidiga ravitud patsientidel oluliselt ravi algul kasutatud opioidiannusest.
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Estonian: TOIMEAINE(TE) SISALDUS Üks 0,6 ml süstel sisaldab 12 mg metüülnaltreksoonbromiidi.
English: Each pre-filled syringe contains 0.4 mL of solution for injection.
Estonian: Üks süstel sisaldab 0,4 ml süstelahust.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/007
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/007
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/009
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/009
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Estonian: RAVIMPREPARAADI NIMETUS Relistor 12 mg süstelahus süstlis Metüülnaltreksoonbromiid
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/010
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/010
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LABEL TEXT FOR INTERMEDIATE CARTON (VIAL PRESENTATION)
Estonian: VAHEKARBI ETIKETI TEKST (VIAALI PUHUL)
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/005
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/004
English: There were no clinically relevant changes from baseline in pain scores in either the methylnaltrexone bromide or placebo-treated patients.
Estonian: Ei metüülnaltreksoonbromiidiga ega platseeboga ravitud patsientidel valuskoorides võrreldes lähtetasemega kliiniliselt olulisi muutusi ei toimunud.
English: Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Estonian: samm: Relistori süstimine pakendis sisalduva tagasitõmmatava süstlanõelaga süstimissüstlaga 4b.
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/002
English: Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, vomiting, abdominal pain, palpitations, and blushing have occurred in patients treated with methylnaltrexone bromide.
Estonian: Metüülnaltreksoonbromiidiga ravitud patsientidel on võõrutusnähud sarnased sellele, mida täheldatakse opiaatide ärjätmisel, sealhulgas liighigistamine, külmavärinad, oksendamine, kõhuvalu, palpitatsioonid, punetus.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/463/008
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/008
English: MARKETING AUTHORISATION NUMBER EU/1/08/463/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/08/463/003
English: Breast-feeding
Estonian: • pearinglus
English: Glycine hydrochloride
Estonian: Sage: pearinglus
English: Each pre-filled syringe contains 0.6 mL of solution for injection.
Estonian: Üks süstel sisaldab 0,6 ml süstelahust.
English: 10 March 2014
Estonian: 10. märts 2014
English: The European Commission issued a decision on 10 March 2014.
Estonian: Euroopa Komisjon tegi otsuse 10. märtsil 2014.
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Estonian: Direktiivi 2001/83/EÜ artikli 29 lõike 4 kohase menetluse tulemused
English: What is Valebo?
Estonian: Mis on Valebo?
English: Why was Valebo reviewed?
Estonian: Miks Valebo taotlus uuesti läbi vaadati?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom).
Estonian: See on menetlus, mille käigus üks liikmesriik (viiteliikmesriik, käesoleval juhul Saksamaa) hindab ravimit, et otsustada, kas anda ravimi müügiluba, mis kehtib selles riigis ja teistes liikmesriikides (asjaomased liikmesriigid, praegusel juhul Austria, Belgia, Bulgaaria, Hispaania, Iirimaa, Madalmaad, Portugal, Prantsusmaa, Slovakkia, Sloveenia, Taani, Ungari ja Ühendkuningriik).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Valebo outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom.
Estonian: Euroopa Ravimiameti inimravimite komitee järeldas, et Valebo kasulikkus ületab sellega kaasnevad riskid ning müügiloa võib anda Saksamaal ja järgmistes ELi liikmesriikides: Austria, Belgia, Bulgaaria, Hispaania, Iirimaa, Madalmaad, Portugal, Prantsusmaa, Slovakkia, Sloveenia, Taani, Ungari ja Ühendkuningriik.
English: Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s.
Estonian: Alendroonhape on bisfosfonaat, mida on kasutatud osteoporoosi raviks alates 1990. aastate keskpaigast.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Valebo should be granted marketing authorisation in all concerned Member States for the treatment of postmenopausal women with osteoporosis.
Estonian: Olemasolevate andmete hindamise ja komitees peetud teadusliku arutelu tulemusena jõudis inimravimite komitee järeldusele, et Valebole tuleb anda müügiluba kõigis asjaomastes liikmesriikides menopausijärgses eas naistel osteoporoosi raviks.
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Valebo.
Estonian: 19. detsembril 2013 lõpetas Euroopa Ravimiamet vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele Valebo heakskiitmises.
English: Alfacalcidol is a type of vitamin D (a ‘vitamin D analogue'), which is required for calcium absorption and normal bone formation.
Estonian: Alfakaltsidool on D-vitamiini tüüp (D-vitamiini analoog), mis on vajalik kaltsiumi imendumiseks ja luukoe normaalseks moodustumiseks.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 28 February.
Estonian: Et liikmesriigid ei jõudnud kokkuleppele, pöördus Saksamaa ravimiamet 28. veebruaril vahekohtumenetluseks inimravimite komitee poole.
English: TEVA Pharma B.V. submitted Valebo to the German medicines regulatory agency for a decentralised procedure.
Estonian: esitas Valebo Saksamaa ravimiametile detsentraliseeritud menetluseks.
English: The grounds for the referral was a concern raised by Spain that appropriate data had not been submitted to support a statement which was to be included in the indication for Valebo (in section 4.1 of the summary of product characteristics) that alfacalcidol reduces the rate of falls in older people.
Estonian: Esildise aluseks oli Hispaania tõstatatud küsimus, et ei ole esitatud sobivaid andmeid, mis toetaksid Valebo näidustustesse (ravimi omaduste kokkuvõtte lõiku 4.1) lisatavat väidet, et alfakaltsidool vähendab kukkumissagedust vanematel inimestel.
English: However, although alfacalcidol has been shown in some clinical studies to reduce the risk of falls in older people, the Committee considered that this information should be included under section 5.1 of the summary of product characteristics (and not in section 4.1).
Estonian: Inimravimite komitee leidis, et kuigi mõnes kliinilises uuringus on näidatud, et alfakaltsidool vähendab kukkumisi eakatel inimestel, tuleb see teave lisada ravimi omaduste kokkuvõtte lõiku 5.1 (mitte lõiku 4.1).
English: It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Estonian: See aeglustab osteoklastide ehk luukoe lagundamises osalevate rakkude aktiivsust.
English: Alfacalcidol has been used for many years in women who have been through the menopause.
Estonian: Alfakaltsidooli on kasutatud palju aastaid menopausijärgses eas naistel.
English: Valebo is a combination of tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol.
Estonian: Valebo on kombinatsioonpakend 70 mg alendroonhapet sisaldavatest tablettidest ja 1 mikrogrammi alfakaltsidooli sisaldavatest kapslitest.
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol) EMA/793424/2013 rev.1
Estonian: Teave Valebo ja sarnaste nimetuste kohta (70 mg alendroonhapet sisaldavad tabletid ja 1 mikrogrammi alfakaltsidooli sisaldavad kapslid) EMA/793424/2013 rev.1
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol)
Estonian: Teave Valebo ja sarnaste nimetuste kohta (70 mg alendroonhapet sisaldavad tabletid ja 1 mikrogrammi alfakaltsidooli sisaldavad kapslid)
English: It is to be used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Estonian: Valebot kasutatakse menopausijärgses eas naistel osteoporoosi (luu-urbnemuse) raviks.
English: Horses Intraarticular use Vial (plastic)
Estonian: Süstesuspensioon Hobused Intraartikulaarne Plastviaal
English: Suspension (stem cells): 1 ml
Estonian: Suspensioon (tüvirakud): 1 ml tüvirakusus pensiooni viaal
English: Content
Estonian: Suukaudne
English: 483 mg/g Granules
Estonian: 483 mg/g Graanulid
English: EU (MA) Number
Estonian: Müügiloa number Euroopa Liidus
English: 1 bottle + 1 dosing spoon
Estonian: Pudel (HDPE) 174 g 1 pudel ja 1 doseerimislu sikas
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imprida HCT to Novartis Europharm Limited on 15 October 2009.
Estonian: Euroopa Komisjon andis Imprida HCT müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Novartis Europharm Limited 15. oktoobril 2009.
English: Imprida HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Estonian: Imprida HCT-d võetakse suu kaudu üks tablett üks kord ööpäevas alati samal ajal, soovitavalt hommikul.
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Estonian: Seda turustatakse tablettidena, mis sisaldavad amlodipiini, valsartaani ja hüdroklorotiasiidi järgmistes kogustes: 5/160/12,5 mg, 10/160/12,5 mg, 5/160/25 mg, 10/160/25 mg ja 10/320/25 mg.
English: The Committee recommended that Imprida HCT be given marketing authorisation.
Estonian: Komitee soovitas anda Imprida HCT-le müügiloa.
English: Because the combination of the three active substances has been in use for a number of years, the company presented studies showing that the tablet containing all three substances is absorbed in the body in the same way as the separate tablets.
Estonian: Et kolme toimeaine kombinatsiooni on kasutatud aastaid, esitas ettevõte uuringute tulemused, mis näitasid, et kolme toimeainet koos sisaldav tablett imendus organismis samal viisil kui toimeained eraldi tablettidena.
English: The three active substances in Imprida HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Estonian: Imprida HCT kolm toimeainet on kõrgvererõhu ravimid, mida Euroopa Liidus juba turustatakse.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Imprida HCT which combines the three substances in a single tablet.
Estonian: Inimravimite komitee märkis, et patsiendid, kes juba manustavad neid kolme toimeainet, järgivad raviskeemi tõenäoliselt paremini, kui neile anda Imprida HCT-d, milles on kolm toimeainet ühes tabletis.
English: The main study showed the benefit of the highest strength of Imprida HCT in lowering the blood pressure.
Estonian: Põhiuuring näitas et Imprida HCT suurima annuse kasulikkust vererõhu alandamisel.
English: The daily dose of Imprida HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Estonian: Imprida HCT ööpäevases annuses ei tohi olla üle 10 mg amlodipiini, 320 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: Imprida HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Estonian: Imprida HCT on ravim, mis sisaldab kolme toimeainet: amlodipiini, valsartaani ja hüdroklorotiasiidi.
English: The dose of Imprida HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Estonian: Imprida HCT-d tuleb anda samas annuses kui kolme toimeainet eraldi, mida patsient varem võttis.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Estonian: Kui kaltsiumiioonid sisenevad veresoonte seinte lihaste rakkudesse, tõmbuvad need rakud kokku.
English: The most common side effects with Imprida HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Estonian: Imprida HCT kõige sagedamad kõrvalnähud (esinenud ühel kuni kümnel patsiendil sajast) on hüpokaleemia (vere kaaliumivaegus), peapööritus, peavalu, hüpotensioon (madal vererõhk) düspepsia (kõrvetised), pollakiuuria (ebanormaalselt sage urineerimine), väsimus ja ödeem (turse).
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Imprida HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Estonian: Lisaks viidi läbi põhiuuring 2271-l mõõduka kuni raske kõrgvererõhuga patsiendil, kellele anti Imprida HCT-d suurimas annuses (320 mg valsartaani, 10 mg amlodipiini ja 25 mg hüdroklorotiasiidi).
English: Imprida HCT should not be used in people who may be hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Imprida HCT.
Estonian: Imprida HCT-d ei tohi kasutada patsiendid, kes võivad olla selle toimeainete, teiste sulfoonamiidide, dihüdropüridiini derivaatide klassi kuuluvate ravimite või Imprida HCT mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce.
Estonian: Blokeerides retseptorid, millele angiotensiin II tavaliselt kinnitub, peatab valsartaan selle hormooni toime ja soodustab veresoonte laienemist ning vererõhu alanemist.
English: Other information about Imprida HCT:
Estonian: Muu teave Imprida HCT kohta
English: Treatment with the highest strength of Imprida HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Estonian: Ravi Imprida HCT suurima annusega oli vererõhu alandamisel efektiivsem kui ravi mis tahes kahe toimeaine kombinatsiooniga.
English: For the full list of all side effects reported with Imprida HCT, see the Package Leaflet.
Estonian: Imprida HCT kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Imprida HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Estonian: Imprida HCT-d manustanud patsientidel alanes vererõhk keskmiselt 39,7/24,7 mmHg võrra, ent valsartaani-hüdroklorotiasiidi, valsartaani-amlodipiini ja hüdroklorotiasiidi-amlodipiini kombinatsiooni manustanud patsientidel vastavalt 32/19,7 mmHg, 33,5/21,5 mmHg ja 31,5/19,5 mmHg võrra.
English: The full EPAR for Imprida HCT can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Imprida HCT kohta leiate siit.
English: Imprida HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Estonian: Imprida HCT-d kasutatakse essentsiaalse hüpertensiooniga (kõrgvererõhutõvega) täiskasvanutel, kelle vererõhk allub piisavalt ravile amlodipiini, valsartaani ja hüdroklorotiasiidi kombinatsiooniga.
English: What is the risk associated with Imprida HCT?
Estonian: Mis riskid Imprida HCT-ga kaasnevad?
English: What is Imprida HCT?
Estonian: Mis on Imprida HCT?
English: Patients received either Imprida HCT or one of the three combinations containing only two of the active substances for eight weeks.
Estonian: Patsiendid manustasid kaheksa nädala jooksul kas Imprida HCT-d või kahe toimeaine kolmest kombinatsioonist ühte kombinatsiooni.
English: Finally, Imprida HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Estonian: Imprida HCT-d ei tohi anda ka patsientidele, kellel on ravile allumatu hüpokaleemia (vere kaaliumivaegus), hüponatreemia (vere naatriumivaegus) või hüperkaltseemia (suur kaltsiumisisaldus veres), samuti patsientidele, kellel on hüperurikeemia (vere liigne uureasisaldus), mis põhjustab haigusnähte.
English: The CHMP therefore decided that Imprida HCT's benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Estonian: Seetõttu otsustas inimravimite komitee, et Imprida HCT kasulikkus essentsiaalse hüpertensiooniga täiskasvanutel, kelle vererõhk allub piisavalt ravile amlodipiini, valsartaani ja hüdroklorotiasiidi kombinatsiooniga, on suurem kui sellega kaasnevad riskid.
English: Why has Imprida HCT been approved?
Estonian: Miks Imprida HCT heaks kiideti?
English: Imprida HCT amlodipine, valsartan and hydrochlorothiazide EPAR summary for the public
Estonian: Imprida HCT amlodipiin, valsartaan ja hüdroklorotiasiid
English: What benefit has Imprida HCT shown during the studies?
Estonian: Milles seisneb uuringute põhjal Imprida HCT kasulikkus?
English: For all doses, Imprida HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Estonian: Imprida HCT kõigi annuste kohta tõendati, et nende mõju on sama mis kolmel toimeainel eraldi võetuna.
English: How is Imprida HCT used?
Estonian: Kuidas Imprida HCT-d kasutatakse?
English: How does Imprida HCT work?
Estonian: Kuidas Imprida HCT toimib?
English: What is Imprida HCT used for?
Estonian: Milleks Imprida HCT-d kasutatakse?
English: How has Imprida HCT been studied?
Estonian: Kuidas Imprida HCT-d uuriti?
English: An alert card will also be given to patients.
Estonian: Patsientidele antakse ka hoiatuskaart.
English: After 24 weeks, a 20% improvement in symptoms was seen in 74% of Hulio-treated patients (270 of 363) and 76% of Humira treated patients (271 of 358).
Estonian: 24 nädala pärast täheldati sümptomite 20% paranemist 74%-l Hulioga ravitud patsientidest (270 patsienti 363st) ja 76%-l Humiraga ravitud patsientidest (271 patsienti 358st).
English: What measures are being taken to ensure the safe and effective use of Hulio?
Estonian: Mis meetmed võetakse, et tagada Hulio ohutu ja efektiivne kasutamine?
English: Further information on Hulio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Hulio kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Hulio
Estonian: Muu teave Hulio kohta
English: Hulio (adalimumab)
Estonian: Hulio (adalimumaab)
English: This means that Hulio is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Estonian: See tähendab, et Hulio on väga sarnane teise bioloogilise ravimiga (võrdlusravimiga), millel juba on ELis müügiluba.
English: What is Hulio and what is it used for?
Estonian: Mis on Hulio ja milleks seda kasutatakse?
English: After training, patients or their carers may inject Hulio if their doctor considers it appropriate.
Estonian: Patsiendid või nende hooldajad võivad pärast asjakohase väljaõppe saamist süstida Huliot ise, kui arst peab seda kohaseks.
English: As for all medicines, data on the use of Hulio are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Hulio kasutamise kohta pidevat järelevalvet.
English: Hulio is available as a solution for injection under the skin in a vial or pre-filled syringe or pen and is usually given every 2 weeks.
Estonian: Huliot turustatakse naha alla süstitava süstelahusena viaalis või eeltäidetud süstlas või pensüstlas ja tavaliselt manustatakse seda iga 2 nädala järel.
English: Side effects reported with Hulio are carefully evaluated and any necessary action taken to protect patients.
Estonian: Hulio kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Hulio is mostly used in adults when their condition is severe, moderately severe or getting worse, or when patients cannot use other treatments.
Estonian: Huliot kasutatakse enamasti raskes, mõõdukalt raskes või halvenevas seisundis täiskasvanutel või kui patsiendid ei saa muid ravimeid kasutada.
English: What are the risks associated with Hulio?
Estonian: Mis riskid Hulioga kaasnevad?
English: Hulio is a medicine that acts on the immune system and is used to treat the following conditions:
Estonian: Hulio on immuunsüsteemile toimiv ravim ja seda kasutatakse järgmiste haiguste raviks:
English: Therefore, the Agency's view was that, as for Humira, the benefit of Hulio outweighs the identified risk and it can be authorised.
Estonian: Seetõttu on amet arvamusel, et nagu ka Humira korral, ületab Hulio kasulikkus sellega kaasnevad riskid ja seda võib kasutada.
English: The reference medicine for Hulio is Humira.
Estonian: Hulio võrdlusravim on Humira.