FrancophonIA/ELRC3.0 huggingface dataset:
English: Consult your doctor if your symptoms return but do not stop taking ZYPREXA unless your doctor tells you to.
Estonian: ZYPREXA ööpäevane annus on 5 mg ja 20 mg. Sümptomite taastumisel konsulteerige arstiga, kuid ärge katkestage ZYPREXA kasutamist ilma arsti korralduseta.
English: ZYPREXA 15 mg coated tablets
Estonian: ZYPREXA 15 mg kaetud tabletid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each coated tablet contains 2.5 mg olanzapine
Estonian: TOIMEAINE(TE) SISALDUS Iga kaetud tablett sisaldab 2,5 mg olansapiini.
English: EU/1/96/022/011 - ZYPREXA - 7.5 mg - coated tablets - 28 tablets, per box.
Estonian: EU/1/96/022/011 - ZYPREXA - 7,5 mg - kaetud tabletid - 28 tabletti karbis.
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Estonian: Sageli esinevad kõrvaltoimed (võivad mõjutada kuni 1 kasutajat 10-st): mõnede vererakkude hulga ja ringlevate rasvade sisalduse muutused; ravi varajases staadiumis maksaensüümide aktiivsuse ajutine tõus, suhkrusisalduse tõus veres ja uriinis; kusihappe- ja kreatiinfosfokinaasitaseme tõus veres; näljatunne; pearinglus; rahutus; värisemine;ebatavalised liigutused (düskineesia); kõhukinnisus; suukuivus; lööve; jõuetus; äärmine väsimus; vedelikupeetus, mis võib viia käte, pahkluude või jalgade paistetuseni; palavik ja liigesvalu, seksuaalsuse häired, nt libiido langus meestel ja naistel või erektsioonihäired meestel.
English: What ZYPREXA Injection looks like and contents of the pack ZYPREXA comes as a yellow powder in a vial.
Estonian: ZYPREXA't väljastatakse viaalis kollase pulbrina.
English: EU/1/96/022/006 - ZYPREXA - 7.5 mg - coated tablets - 56 tablets, per box.
Estonian: EU/1/96/022/006 - ZYPREXA - 7,5 mg - kaetud tabletid - 56 tabletti karbis.
English: EU/1/96/022/037 - ZYPREXA - 7.5 mg - coated tablets - 98 tablets, per box.
Estonian: EU/1/96/022/037 - ZYPREXA - 7,5 mg - kaetud tabletid - 98 tabletti karbis.
English: Store in the original package in order to protect from light and moisture.
Estonian: Niiskuse ja valguse eest kaitsmiseks hoida originaalpakendis.
English: EU/1/96/022/029 - ZYPREXA - 2.5 mg - coated tablets - 70 tablets, per box.
Estonian: EU/1/96/022/029 - ZYPREXA - 2,5 mg - kaetud tabletid - 70 tabletti karbis.
English: EU/1/96/022/031 - ZYPREXA - 7.5 mg - coated tablets - 70 tablets, per box.
Estonian: EU/1/96/022/031 - ZYPREXA - 7,5 mg - kaetud tabletid - 70 tabletti karbis.
English: EU/1/96/022/033 - ZYPREXA - 15 mg - coated tablets - 70 tablets, per box.
Estonian: EU/1/96/022/033 - ZYPREXA - 15 mg - kaetud tabletid - 70 tabletti karbis.
English: EU/1/96/022/009 - ZYPREXA - 10 mg - coated tablets - 28 tablets, per box.
Estonian: EU/1/96/022/009 - ZYPREXA - 10 mg - kaetud tabletid - 28 tabletti karbis.
English: EU/1/96/022/034 - ZYPREXA - 20 mg - coated tablets - 70 tablets, per box.
Estonian: EU/1/96/022/034 - ZYPREXA - 20 mg - kaetud tabletid - 70 tabletti karbis.
English: EU/1/96/022/012 - ZYPREXA - 15 mg - coated tablets - 28 tablets, per box.
Estonian: EU/1/96/022/012 - ZYPREXA - 15 mg - kaetud tabletid - 28 tabletti karbis.
English: EU/1/96/022/035 - ZYPREXA - 2.5 mg - coated tablets - 98 tablets, per box.
Estonian: EU/1/96/022/035 - ZYPREXA - 2,5 mg - kaetud tabletid - 98 tabletti karbis.
English: EU/1/96/022/025 - ZYPREXA - 7.5 mg - coated tablets - 35 tablets, per box.
Estonian: EU/1/96/022/025 - ZYPREXA - 7,5 mg - kaetud tabletid - 35 tabletti karbis.
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 10 mg powder for solution for injection olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 10 mg süstelahuse pulber olansapiin
English: LIST OF EXCIPIENTS Lactose monohydrate, tartaric acid, hydrochloric acid, sodium hydroxide
Estonian: ABIAINED Laktoosmonohüdraat, viinhape, soolhape, naatriumhüdroksiid.
English: EU/1/96/022/023 - ZYPREXA - 2.5 mg - coated tablets - 35 tablets, per box.
Estonian: EU/1/96/022/023 - ZYPREXA - 2,5 mg - kaetud tabletid - 35 tabletti karbis.
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 7.5 mg coated tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 7,5 mg kaetud tabletid olansapiin
English: EU/1/96/022/002 - ZYPREXA - 2.5 mg - coated tablets - 28 tablets, per box.
Estonian: EU/1/96/022/002 - ZYPREXA - 2,5 mg - kaetud tabletid - 28 tabletti karbis.
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 20 mg coated tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 20 mg kaetud tabletid Olansapiin
English: EU/1/96/022/040 - ZYPREXA - 20 mg - coated tablets - 98 tablets, per box.
Estonian: EU/1/96/022/040 - ZYPREXA - 20 mg - kaetud tabletid - 98 tabletti karbis.
English: EU/1/96/022/032 - ZYPREXA - 10 mg - coated tablets - 70 tablets, per box.
Estonian: EU/1/96/022/032 - ZYPREXA - 10 mg - kaetud tabletid - 70 tabletti karbis.
English: EU/1/96/022/028 - ZYPREXA - 20 mg - coated tablets - 35 tablets, per box.
Estonian: EU/1/96/022/028 - ZYPREXA - 20 mg - kaetud tabletid - 35 tabletti karbis.
English: EU/1/96/022/004 - ZYPREXA - 5 mg - coated tablets - 28 tablets, per box.
Estonian: EU/1/96/022/004 - ZYPREXA - 5 mg - kaetud tabletid - 28 tabletti karbis.
English: EU/1/96/022/014 - ZYPREXA - 20 mg - coated tablets - 28 tablets, per box.
Estonian: EU/1/96/022/014 - ZYPREXA - 20 mg - kaetud tabletid - 28 tabletti karbis.
English: EU/1/96/022/027 - ZYPREXA - 15 mg - coated tablets - 35 tablets, per box.
Estonian: EU/1/96/022/027 - ZYPREXA - 15 mg - kaetud tabletid - 35 tabletti karbis.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 10 mg COATED TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA 10 mg KAETUD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: Eli Lilly Nederland B.V. Tel: + 31 (0)30 6025800
Estonian: Tel: + 31(0)30 6025800
English: EU/1/96/022/038 - ZYPREXA - 10 mg - coated tablets - 98 tablets, per box.
Estonian: EU/1/96/022/038 - ZYPREXA - 10 mg - kaetud tabletid - 98 tabletti karbis.
English: Inject into a vial of ZYPREXA.
Estonian: Süstige see ZYPREXA viaali.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 20 mg COATED TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA 20 mg KAETUD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 2.5 mg coated tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 2,5 mg kaetud tabletid olansapiin
English: EU/1/96/022/019 - ZYPREXA - 2.5 mg - coated tablets - 56 tablets, per box.
Estonian: EU/1/96/022/019 - ZYPREXA - 2,5 mg - kaetud tabletid - 56 tabletti karbis.
English: EU/1/96/022/039 - ZYPREXA - 15 mg - coated tablets - 98 tablets, per box.
Estonian: EU/1/96/022/039 - ZYPREXA - 15 mg - kaetud tabletid - 98 tabletti karbis.
English: EU/1/96/022/030 - ZYPREXA - 5 mg - coated tablets - 70 tablets, per box.
Estonian: EU/1/96/022/030 - ZYPREXA - 5 mg - kaetud tabletid - 70 tabletti karbis.
English: EU/1/96/022/026 - ZYPREXA - 10 mg - coated tablets - 35 tablets, per box.
Estonian: EU/1/96/022/026 - ZYPREXA - 10 mg - kaetud tabletid - 35 tabletti karbis.
English: EU/1/96/022/022 - ZYPREXA - 20 mg - coated tablets - 56 tablets, per box.
Estonian: EU/1/96/022/022 - ZYPREXA - 20 mg - kaetud tabletid - 56 tabletti karbis.
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1 % and < 1 %).
Estonian: Aeg-ajalt (≥ 0,1% ja < 1%) on registreeritud olansapiinravi ajalist kokkulangemist venoossete trombembooliatega.
English: EU/1/96/022/024 - ZYPREXA - 5 mg - coated tablets - 35 tablets, per box.
Estonian: EU/1/96/022/024 - ZYPREXA - 5 mg - kaetud tabletid - 35 tabletti karbis.
English: EU/1/96/022/036 - ZYPREXA - 5 mg - coated tablets - 98 tablets, per box.
Estonian: EU/1/96/022/036 - ZYPREXA - 5 mg - kaetud tabletid - 98 tabletti karbis.
English: EU/1/96/022/004 28 coated tablets EU/1/96/022/024 35 coated tablets EU/1/96/022/020 56 coated tablets EU/1/96/022/030 70 coated tablets EU/1/96/022/036 98 coated tablets
Estonian: EU/1/96/022/004 28 kaetud tabletid EU/1/96/022/024 35 kaetud tabletid EU/1/96/022/020 56 kaetud tabletid EU/1/96/022/030 70 kaetud tabletid EU/1/96/022/036 98 kaetud tabletti
English: EU/1/96/022/021 - ZYPREXA - 15 mg - coated tablets - 56 tablets, per box.
Estonian: EU/1/96/022/021 - ZYPREXA - 15 mg - kaetud tabletid - 56 tabletti karbis.
English: EU/1/96/022/010 - ZYPREXA - 10 mg - coated tablets - 56 tablets, per box.
Estonian: EU/1/96/022/010 - ZYPREXA - 10 mg - kaetud tabletid - 56 tabletti karbis.
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Estonian: 5 Täheldati neil, kel esines esialgselt normaalne tase tühja kõhu seisundis (< 1,69 mmol/l), mis tõusis kõrgele (≥ 2,26 mmol/l).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 15 mg COATED TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA 15 mg KAETUD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: EU/1/96/022/020 - ZYPREXA - 5 mg - coated tablets - 56 tablets, per box.
Estonian: EU/1/96/022/020 - ZYPREXA - 5 mg - kaetud tabletid - 56 tabletti karbis.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each coated tablet contains 5 mg olanzapine
Estonian: TOIMEAINE(TE) SISALDUS Iga kaetud tablett sisaldab 5 mg olansapiini.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency.
Estonian: Ajakohastatud riskijuhtimiskva tuleb esitada:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA 5 mg COATED TABLETS: BLISTER FOIL LABEL
Estonian: ZYPREXA 5 mg KAETUD TABLETID: BLISTERPAKENDI FOOLIUMI MÄRGISTUS
English: EU/1/96/022/01128 coated tablets EU/1/96/022/025 35 coated tablets EU/1/96/022/006 56 coated tablets EU/1/96/022/031 70 coated tablets EU/1/96/022/037 98 coated tablets
Estonian: EU/1/96/022/011 28 kaetud tabletti EU/1/96/022/025 35 kaetud tabletti EU/1/96/022/006 56 kaetud tabletti EU/1/96/022/031 70 kaetud tabletti EU/1/96/022/037 98 kaetud tabletti
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 10 mg coated tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 10 mg kaetud tabletid Olansapiin
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 10 mg coated tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 10 mg kaetud tabletid olansapiin
English: EU/1/96/022/014 28 coated tablets EU/1/96/022/028 35 coated tablets EU/1/96/022/022 56 coated tablets EU/1/96/022/034 70 coated tablets EU/1/96/022/040 98 coated tablets
Estonian: EU/1/96/022/014 28 kaetud tabletti EU/1/96/022/028 35 kaetud tabletti EU/1/96/022/022 56 kaetud tabletti EU/1/96/022/034 70 kaetud tabletti EU/1/96/022/040 98 kaetud tabletti
English: SPECIAL STORAGE CONDITIONS Do not store above 25º C. Store in original package in order to protect from light
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril kuni 25 °C.
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 5 mg coated tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 5 mg kaetud tabletid Olansapiin
English: EU/1/96/022/009 28 coated tablets EU/1/96/022/026 35 coated tablets EU/1/96/022/010 56 coated tablets EU/1/96/022/032 70 coated tablets EU/1/96/022/038 98 coated tablets
Estonian: EU/1/96/022/009 28 kaetud tabletti EU/1/96/022/026 35 kaetud tabletti EU/1/96/022/010 56 kaetud tabletti EU/1/96/022/032 70 kaetud tabletti EU/1/96/022/038 98 kaetud tabletti
English: EU/1/96/022/002 28 coated tablets EU/1/96/022/023 35 coated tablets EU/1/96/022/019 56 coated tablets EU/1/96/022/029 70 coated tablets EU/1/96/022/035 98 coated tablets
Estonian: EU/1/96/022/002 28 kaetud tabletti EU/1/96/022/023 35 kaetud tabletti EU/1/96/022/019 56 kaetud tabletti EU/1/96/022/029 70 kaetud tabletti EU/1/96/022/035 98 kaetud tabletti
English: EU/1/96/022/012 28 coated tablets EU/1/96/022/027 35 coated tablets EU/1/96/022/021 56 coated tablets EU/1/96/022/033 70 coated tablets EU/1/96/022/039 98 coated tablets
Estonian: EU/1/96/022/012 28 kaetud tabletti EU/1/96/022/027 35 kaetud tabletti EU/1/96/022/021 56 kaetud tabletti EU/1/96/022/033 70 kaetud tabletti EU/1/96/022/039 98 kaetud tabletti
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 15 mg coated tablets Olanzapine
Estonian: RAVIMPREPARAADI NIMETUS ZYPREXA 15 mg kaetud tabletid Olansapiin
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Estonian: 7 Olansapiinravi järsul lõpetamisel on väga harva täheldatud selliseid ägedaid sümptomeid nagu higistamine, unetus, treemor, ärevus, iiveldus ja oksendamine.
English: Hepatic impairment
Estonian: Teadmata suukuivus.
English: Administer the solution intramuscularly.
Estonian: Manustage lahus intramuskulaarselt.
English: 13Undesirable effects listed and observed following administration of oral and LAIM olanzapine, which may also occur following administration of RAIM olanzapine.
Estonian: 13 Suukaudse ja pika toimega intramuskulaarse olansapiini manustamise järgselt täheldatud kõrvaltoimed, mis võivad tekkida ka pärast kiire toimega intramuskulaarse olansapiini manustamist.
English: Some of these effects may be serious and may require medical attention.
Estonian: Mõned neist toimetest võivad olla tõsiseid ja vajada arstiabi.
English: You can take Ifirmasta with or without food.
Estonian: Ifirmasta't võib võtta koos toiduga või ilma.
English: See also information under the heading “Do not take Ifirmasta”.
Estonian: Vt ka teavet lõigus „Ärge võtke Ifirmasta't”.
English: Date of first authorisation: 1 December 2008 Date of latest renewal: 26 August 2013
Estonian: Müügiloa esmase väljastamise kuupäev: 1.detsember 2008 Müügiloa viimase uuendamise kuupäev: 26.august 2013
English: PVC/PE/PVDC/Alu
Estonian: PVC/PE/PVDC/Al
English: Therefore, the use of Ifirmasta is not recommended.
Estonian: Seetõttu ei ole Ifirmasta kasutamine soovitatav.
English: What Ifirmasta is and what it is used for
Estonian: Mis ravim on Ifirmasta ja milleks seda kasutatakse
English: However the terminal halflife was not significantly altered.
Estonian: Kuid poolväärtusaeg ei olnud märkimisväärselt muutunud.
English: Other medicines and Ifirmasta
Estonian: Muud ravimid ja Ifirmasta
English: If you forget to take Ifirmasta
Estonian: Kui te unustate Ifirmasta´t võtta
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Estonian: Antud hetkel teadaolevad andmed on esitatud lõikudes 4.8; 5.1 ja 5.2, aga soovitusi annustamise kohta ei ole võimalik anda.
English: What you need to know before you take Ifirmasta
Estonian: Mida on vaja teada enne Ifirmasta võtmist
English: What Ifirmasta contains - The active substance is irbesartan.
Estonian: Mida Ifirmasta sisaldab - Toimeaine on irbesartaan.
English: Ifirmasta should not be given to children under 18 years of age.
Estonian: Ifirmasta't ei tohi anda lastele ja alla 18-aastastele noorukitele.
English: The safety and efficacy of Ifirmasta in children aged 0 to 18 has not been established.
Estonian: Ifirmasta ohutus ja efektiivsus lastel vanuses 0 kuni 18 aastat ei ole tõestatud.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Estonian: Täpne teave selle ravimi kohta on Euroopa Ravimiameti kodulehel http://www.ema.europa.eu/.
English: Additional information on irbesartan interactions:
Estonian: Lisainformatsioon irbesartaani koostoimete kohta:
English: musculoskeletal pain*
Estonian: muskuloskeletaalne valu*
English: White, oval tablets.
Estonian: Valged, ovaalsed tabletid.
English: - Patients with high blood pressure
Estonian: - Kõrge vererõhuga patsiendid
English: Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code: C09CA04.
Estonian: Farmakoterapeutiline rühm: angiotensiin-II antagonist, ATC-kood: C09CA04.
English: What Ifirmasta is and what it is used for What you need to know before you take Ifirmasta How to take Ifirmasta
Estonian: Mis ravim on Ifirmasta ja milleks seda kasutatakse Mida on vaja teada enne Ifirmasta võtmist Kuidas Ifirmasta´t võtta
English: Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Estonian: Irbesartaani AUC ja Cmax olid pisut suuremad eakatel (≥ 65-aastastel) kui noorematel isikutel (18 kuni 40- aastastel).
English: Such conditions should be corrected before the administration of Ifirmasta.
Estonian: Sellised seisundid tuleb korrigeerida enne ravi alustamist Ifirmasta´ga.
English: If a child swallows some tablets, contact your doctor immediately.
Estonian: Kui laps neelas mõne tableti, võtke kohe ühendust oma arstiga.
English: Aliskiren-containing products or ACE-inhibitors:
Estonian: Aliskireeni sisaldavad ravimid või AKE-inhibiitorid:
English: It is important that you continue to take Ifirmasta until your doctor tells you otherwise.
Estonian: Oluline on kasutada Ifirmasta't nii kaua kuni arst ei ole otsustanud teisiti.
English: If you take more Ifirmasta than you should If you accidentally take too many tablets, contact your doctor immediately.
Estonian: Kui te võtate Ifirmasta´t rohkem kui ette nähtud Kui võtsite kogemata liiga palju tablette, võtke kohe ühendust oma arstiga.
English: Ifirmasta is for oral use.
Estonian: Ifirmasta on suukaudseks kasutamiseks.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Estonian: Alltoodud kõrvaltoimete esinemissagedus on defineeritud järgmiselt: väga sage (≥ 1/10); sage (≥ 1/100 kuni < 1/10); aeg-ajalt (≥ 1/1000 kuni < 1/100); harv (≥ 1/10 000 kuni < 1/1000); väga harv (< 1/10 000).
English: vertigo, headache
Estonian: vertiigo, peavalu
English: No specific information is available on the treatment of overdosage with Ifirmasta.
Estonian: Üleannustamise ravi kohta ei ole spetsiifilist informatsiooni.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3000
Estonian: Titaandioksiid (E171) Makrogool 3000 Talk
English: Uncommon: may affect up to 1 in 100 people
Estonian: Aeg-ajalt: võib mõjutada kuni 1 inimest 100-st.
English: How to take Ifirmasta
Estonian: Kuidas Ifirmasta't võtta
English: Although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dose adjustment is not usually necessary for older people.
Estonian: Kuigi üle 75-aastastel patsientidel võib kaaluda ravi alustamist annusega 75 mg, ei ole annuse kohandamine eakatel tavaliselt vajalik.
English: No significant effects on the number of corpora lutea, implants, or live foetuses were observed.
Estonian: Ei täheldatud märkimisväärset mõju kollaskehade arvule, implantaatidele ega elusloodetele.
English: The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
Estonian: Maksimaalne vererõhku langetav toime peaks saabuma 4…6 nädalal pärast ravi alustamist.
English: Blister (PVC/PE/PVDC/Alu): 56 x 1 film-coated tablets in perforated unit dose blisters in box.
Estonian: Blister (PVC/PE/PVDC/Al): 56 x 1 õhukese polümeerikattega tablett üksikannusena perforeeritud blistris ja karbis.
English: Blister (PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 or 98 film-coated tablets in box are available.
Estonian: Blister (PVC/PE/PVDC/Al): 14, 28, 30, 56, 84, 90 või 98 õhukese polümeerikattega tabletti karbis.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Ifirmasta (see section 4.4).
Estonian: Eelnev ravi diureetikumi suurte annustega võib põhjustada vedeliku mahu vähenemist ja hüpotensiooni ohtu Ifirmasta´ga ravi alustamisel (vt lõik 4.4).
English: Irbesartan did not affect survival, development, or reproduction of offspring.
Estonian: Irbesartaan ei mõjutanud järglaste elulemust, arengut ega reproduktsiooni.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Estonian: IDNT oli topeltpime, kontrollgrupiga, haigestumuse ja suremuse uuring, kus võrreldi irbesartaani, amlodipiini ja platseebot.
English: Ifirmasta belongs to a group of medicines known as angiotensin-II receptor antagonists.
Estonian: Ifirmasta kuulub ravimite gruppi, mida tuntakse angiotensiin-II retseptori antagonistidena.
English: Ifirmasta is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Estonian: Ifirmasta't ei soovitata imetavatele emadele ning arst võib soovitada teile mõne muu ravimi kui soovite last rinnaga toita, eriti kui tegemist on vastsündinu või enneaegse imikuga.
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Estonian: Uuring käsitles irbesartaani pikaajalist (2 aastat) toimet kliinilise (manifesteerunud) proteinuuria (uriini albumiini ekskretsiooni määr (urinary albumin excretion rate, UAER) > 300 mg/ööpäevas ja UAER suurenemine vähemalt 30% algväärtusest) tekkele.
English: Studies in animals indicate that the radiolabelled irbesartan is detected in rat and rabbit foetuses.
Estonian: Loomkatsed näitavad, et radioaktiivselt märgistatud irbesartaani on leitav rottide ja küülikute loodetes.
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Estonian: Toimemehhanism: irbesartaan on tugevatoimeline, suukaudselt aktiivne, selektiivne angiotensiin-II retseptori (tüüp AT1) antagonist.
English: How to store Ifirmasta
Estonian: Kuidas Ifirmasta't säilitada
English: Your doctor may need to change your dose and/or to take other precautions: - If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Ifirmasta” and “Warnings and precautions”).
Estonian: Teie arst võib muuta teie ravimi annust ja/või rakendada teisi ettevaatusabinõusid: - Kui te võtate AKE-inhibiitorit või aliskireeni (vt ka teavet lõikudes „Ärge võtke Ifirmasta't ja
English: Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)].
Estonian: Ligikaudu 33% irbesartaani grupi patsientidest esines esmane liittulemusnäitaja, võrreldes 39% ja 41% platseebo ja amlodipiini grupis [suhtelise riski alanemine 20% vs platseebo (p = 0,024) ja suhtelise riski alanemine 23% võrreldes amlodipiiniga (p = 0,006)].
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Estonian: Suukaudsel manustamisel imendub irbesartaan hästi: absoluutse biosaadavuse uuringute andmetel ligikaudu 60…80%.
English: The usual dose is 150 mg once a day (two tablets a day).
Estonian: Tavaline annus on 150 mg üks kord ööpäevas (kaks tabletti ööpäevas).
English: Very common: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Estonian: Väga sage: hüperkaleemiat* esines diabeediga patsientidel sagedamini irbesartaani saavate patsientide grupis kui platseebo grupis.
English: Adverse reactions additionally reported from post-marketing experience are also listed.
Estonian: Loetellu on lisatud ka turuletulekujärgselt esinenud kõrvaltoimeid.