FrancophonIA/ELRC3.0 huggingface dataset:
English: White, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Estonian: Valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “2.5” kohale “OLA”.
English: INFORMATION IN BRAILLE Olanzapine Apotex 7.5 mg film-coated tablet
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Olanzapine Apotex 7,5 mg õhukese polümeerikattega tablett
English: • Each Olanzapine Apotex 15 mg orodispersible tablet contains 15 mg olanzapine.
Estonian: • Iga Olanzapine Apotex 15 mg suus dispergeeruv tablett sisaldab 15 mg olansapiini.
English: Aluminium/aluminium blister strips in cartons of 28 film-coated tablets per carton.
Estonian: Alumiinium/alumiinimblisterribadel karpides, mis sisaldavad 28 õhukese polümeerikattega tabletti.
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 muutused; ringlevate rasvade sisalduse muutused ja 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.
English: If you get any side effects talk to your doctor or pharmacist.
Estonian: Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely ( ≥ 0.01% and < 0.1%) when olanzapine is stopped abruptly.
Estonian: Olansapiinravi järsul katkestamisel on harva (≥ 0,01% ja < 0,1%) registreeritud ägedaid sümptomeid nagu higistamine, unetus, treemor, ärevus, iiveldus või oksendamine.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 7.5 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 7,5 mg õhukese polümeerikattega tabletid
English: Common: Elevated cholesterol levels
Estonian: Sage: Kolesteroolitaseme tõus15
English: • Olanzapine Apotex 2.5 mg film-coated tablets are available in blisters packs of 28 tablets.
Estonian: • Olanzapine Apotex 2,5 mg polümeerikattega tabletid on saadaval 28 tabletti sisaldavates blisterpakkides.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Estonian: Kerged, mööduvad antikolinergilised toimed, sh. kõhukinnisus ja
English: Do not stop taking your tablets just because you feel better.
Estonian: Kui te lõpetate Olanzapine Apotex'i võtmise Ärge lõpetage tablettide kasutamist kohe, kui tunnete ennast paremini.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga suus dispergeeruv tablett sisaldab 20 mg olansapiini.
English: • Olanzapine Apotex 5 mg and 10 mg orodispersible tablets are available in blisters packs of 28 , 56
Estonian: • Olanzapine Apotex 5 mg ja 10 mg polümeerikattega tabletid on saadaval 28, 56 ja 98 tabletti sisaldavates blisterpakkides.
English: Hepatic impairment
Estonian: Kõhuseina pingsus
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 10 mg olansapiini.
English: • Each Olanzapine Apotex 10 mg orodispersible tablet contains 10 mg olanzapine.
Estonian: • Iga Olanzapine Apotex 10 mg suus dispergeeruv tablett sisaldab 10 mg olansapiini.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 15 mg olansapiini.
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘20' on the other side.
Estonian: Kollased, ümmargused, lamedad radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “20” kohale “OL”.
English: Dyskinesia6
Estonian: Ülitundlikkus11
English: • Olanzapine Apotex 2.5 mg are white, round, biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘2.5' on the other side.
Estonian: • Olanzapine Apotex 2,5 mg on valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “2.5” kohale “OLA”.
English: 28 orodispersible tablets 56 orodispersible tablets
Estonian: 56 suus dispergeerruvat tabletti
English: Aluminium/aluminium blister strips in cartons of 28 and 56 film-coated tablets per carton.
Estonian: Alumiinium/alumiinimblisterribadel karpides, mis sisaldavad 28 ja 56 õhukese polümeerikattega tabletti.
English: • Olanzapine Apotex 10 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Estonian: • Olanzapine Apotex 10 mg on valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “10” kohale “OLA”.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg olanzapine.
Estonian: TOIMEAINE(TE) SISALDUS Iga tablett sisaldab 5 mg olansapiini.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga õhukese polümeerikattega tablett sisaldab 2,5 mg olansapiini.
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘7.5' on the other side.
Estonian: Valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “7.5” kohale “OLA”.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets 56 film-coated tablets 98 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use.
Estonian: RAVIMVORM JA PAKENDI SUURUS 28 suus dispergeerruvat tabletti 56 suus dispergeerruvat tabletti 98 õhukese polümeerikattega tabletti
English: INFORMATION IN BRAILLE Olanzapine Apotex 20 mg orodispersible tablet
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Olanzapine Apotex 20 mg suus dispergeerruv tablett
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 2,5 mg õhukese polümeerikattega tabletid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga suus dispergeeruv tablett sisaldab 15 mg olansapiini.
English: • Each Olanzapine Apotex 5 mg orodispersible tablet contains 5 mg olanzapine.
Estonian: • Iga Olanzapine Apotex 5 mg suus dispergeeruv tablett sisaldab 5 mg olansapiini.
English: Mutagenicity
Estonian: Amneesia9
English: • Olanzapine Apotex 5 mg are white, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Estonian: • Olanzapine Apotex 5 mg on valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “5” kohale “OLA”.
English: • Olanzapine Apotex 10 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Estonian: • Olanzapine Apotex 10 mg suus dispergeeruvad tabletid on kollased, ümmargused, lamedad, radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “10” kohale “OL”.
English: • Olanzapine Apotex 5 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Estonian: • Olanzapine Apotex 5 mg suus dispergeeruvad tabletid on kollased, ümmargused, lamedad, radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “5” kohale “OL”.
English: Rhabdomyolysis
Estonian: • Krambid
English: Transient, asymptomatic elevations of hepatic aminotransferases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Estonian: Tavaliselt, eriti ravi varajases faasis, on esinenud maksa aminotransferaaside alaniintransferaasi (ALAT) ja aspartaattransferaasi (ASAT) aktiivsuse mööduvat, asümptomaatilist tõusu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga õhukese polümeerikattega tablett sisaldab 10 mg olansapiini.
English: 11 Adverse event identified from spontaneous post-marketing reporting with frequency determined utilising the Olanzapine Integrated Database.
Estonian: 11 Kõrvaltoime on identifitseeritud spontaansetest turuletulekujärgsetest teatistest esinemissagedusega,
English: Abdominal distension
Estonian: Tardiivne düskineesia
English: Stuttering
Estonian: Krambid
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 2.5 mg film-coated tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 2,5 mg õhukese polümeerikattega tabletid olansapiin
English: (≥ 6.2 mmol/l).
Estonian: muutumine kõrgeks (≥ 6,2 mmol/l) oli väga sage.
English: INFORMATION IN BRAILLE Olanzapine Apotex 15 mg orodispersible tablet
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Olanzapine Apotex 15 mg suus dispergeerruv tablett
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 20 mg suus dispergeerruvad tabletid
English: There is a risk of feeling drowsy when you are given Olanzapine Apotex.
Estonian: Olanzapine Apotex'i kasutamise ajal võite end uimasena tunda.
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Estonian: Selle uuringu prospektiivne sekundaarne analüüs, mis hindas meeleolu punktisumma muutust ravi algusest kuni lõpuni, näitas olansapiini (-6,0) statistiliselt olulist paremust (p=0,001) haloperidooliga (-3,1) võrreldes.
English: INFORMATION IN BRAILLE Olanzapine Apotex 5 mg orodispersible tablet
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Olanzapine Apotex 5 mg suus dispergeerruv tablett
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side.
Estonian: Kollased, ümmargused, lamedad radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “15” kohale “OL”.
English: • Each Olanzapine Apotex 5 mg film-coated tablet contains 5 mg olanzapine.
Estonian: • Iga Olanzapine Apotex 5 mg õhukese polümeerikattega tablett sisaldab 5 mg olansapiini.
English: • Each Olanzapine Apotex 10 mg film-coated tablet contains 10 mg olanzapine.
Estonian: • Iga Olanzapine Apotex 10 mg õhukese polümeerikattega tablett sisaldab 10 mg olansapiini.
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘10' on the other side.
Estonian: Kollased, ümmargused, lamedad radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “10” kohale “OL”.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription INSTRUCTIONS ON USE
Estonian: RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAVAD TOOTJAD
English: • Olanzapine Apotex 15 mg orodispersible tablets are yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘15' on the other side
Estonian: • Olanzapine Apotex 15 mg suus dispergeeruvad tabletid on kollased, ümmargused, lamedad, radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “15” kohale “OL”.
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg orodispersible tablet
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Olanzapine Apotex 10 mg suus dispergeerruv tablett
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘10' on the other side.
Estonian: Valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “10” kohale “OLA”.
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Apotex unless your doctor tells you to.
Estonian: Olanzapine Apotex'i ööpäevane annus on 5 mg ja 20 mg. Sümptomite taastumisel konsulteerige arstiga, kuid ärge katkestage Olanzapine Apotex'i kasutamist ilma arsti korralduseta.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga suus dispergeeruv tablett sisaldab 5 mg olansapiini.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 15 mg suus dispergeerruvad tabletid
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 5 mg suus dispergeerruvad tabletid
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 10 mg suus dispergeerruvad tabletid
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 5 mg orodispersible tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 5 mg suus dispergeerruvad tabletid olansapiin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 15 mg orodispersible tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 15 mg suus dispergeerruvad tabletid olansapiin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 20 mg orodispersible tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 20 mg suus dispergeerruvad tabletid olansapiin
English: White, round biconvex film-coated tablets engraved ‘APO' on one side and ‘OLA' over ‘5' on the other side.
Estonian: Valged, ümmargused, kaksikkumerad õhukese polümeerikattega tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “5” kohale “OLA”.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Apotex 10 mg orodispersible tablets olanzapine
Estonian: RAVIMPREPARAADI NIMETUS Olanzapine Apotex 10 mg suus dispergeerruvad tabletid olansapiin
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/635/008-009 EU/1/10/635/017 BATCH NUMBER
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/10/635/008-009
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg olanzapine.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga õhukese polümeerikattega tablett sisaldab 5 mg olansapiini.
English: Carmellose calcium
Estonian: Karmellooskaltsium
English: Metabolism and nutrition disorders Weight gain
Estonian: Ainevahetus- ja toitumishäired
English: Aluminium/aluminium blister strips in cartons of 28, 56 and 98 orodispersible tablets per carton Not all pack sizes may be marketed.
Estonian: Alumiinium/alumiinimblisterribadel karpides, mis sisaldavad 28, 56 ja 98 suus dispergeeruvat tabletti karbi kohta.
English: Talk to your doctor or pharmacist before taking Olanzapine Apotex.
Estonian: Hoiatused ja ettevaatusabinõud Enne Olanzapine Apotex'i võtmist pidage nõu oma arsti või apteekriga.
English: EU/1/10/635/010-011 EU/1/10/635/018
Estonian: EU/1/10/635/018
English: Yellow round flat faced radial edge tablets engraved ‘APO' on one side and ‘OL' over ‘5' on the other side.
Estonian: Kollased, ümmargused, lamedad, radiaalse servaga tabletid, mille ühele küljele on sisse pressitud “APO” ja teisele küljele numbri “5” kohale “OL”.
English: Hypersensitivity11
Estonian: Düsartria Kogelemine11
English: Parkinsonism6
Estonian: Pearinglus Akatiisia6
English: INFORMATION IN BRAILLE Olanzapine Apotex 10 mg film-coated tablet
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Olanzapine Apotex 10 mg õhukese polümeerikattega tablett
English: London, 30 May 2008 Doc.
Estonian: London, 30. mai 2008 Dok.
English: Ref. EMEA/245771/2008
Estonian: viide: EMEA/402804/2008
English: What is Tygacil?
Estonian: Mis on Tygacil?
English: Both antibiotics were given for up to two weeks.
Estonian: Mõlemat antibiootikumi manustati kuni kaks nädalat.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Juhul kui te osalete kliinilises uuringus ja vajate oma ravi kohta lisateavet, pöörduge palun arsti poole, kes teile ravi määras.
English: Following the CHMP's opinion, it usually takes around six weeks for the European Commission to update the licence.
Estonian: Pärast inimravimite komitee arvamuse vastuvõtmist kulub tavaliselt ligikaudu kuus nädalat, enne kui Euroopa Komisjon loa uuendab.
English: The application was at day 150 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 150 päeva, kui ettevõte taotluse tagasi võttis.
English: On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.
Estonian: 22. aprillil 2008 teavitas Wyeth Europa Limited ametlikult inimravimite komiteed oma soovist võtta tagasi taotlus kasutada Tugacili uue näidustuse - keskkonnatekkelise pneumoonia - raviks.
English: The CHMP also had concerns over the measures that the company intended to put in place to minimise the risks associated with the medicine.
Estonian: Lisaks põhjustasid komitee ettevaatlikkust meetmed, mida ettevõte kavatses kasutusele võtta ravimiga seotud riskide minimeerimiseks.
English: The main measure of effectiveness was the number of patients who were cured of their pneumonia within the three weeks after their last dose of antibiotic.
Estonian: Peamiseks efektiivsuse näitajaks oli nende patsientide arv, kes paranesid pneumooniast kolme nädala jooksul pärast viimast antibiootikumiannust.
English: What were the major concerns that led the CHMP to recommend the refusal of the change to the marketing authorisation?
Estonian: Mis olid ettevaatlikkuse peamised põhjused, mille tõttu inimravimite komitee soovitas müügiloa muutmisest keelduda?
English: By blocking the production of new proteins, the bacteria cannot multiply and they eventually die.
Estonian: Kui uusi valke ei saa toota, ei ole bakterid võimelised paljunema ja lõpuks hävivad.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Tygacil had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Inimravimite komitee oli tagasivõtmise ajal seepärast arvamusel, et Tygacili kasulikkus ei ole küllaldaselt tõendatud ega ületa tuvastatud riske.
English: Tigecycline works by blocking the bacteria's ribosomes, the parts of the bacterial cells where new proteins are made.
Estonian: Tigetsükliin blokeerib bakterite ribosoome, mis on bakterirakkude osad, kus toodetakse uusi valke.
English: The effectiveness of Tygacil was tested in two main studies involving a total of 846 adults who needed treatment in hospital for community-acquired pneumonia.
Estonian: Tygacili efektiivsust kontrolliti kahes põhiuuringus, kus osales kokku 846 täiskasvanut, kes vajasid keskkonnatekkelise pneumoonia ravi haiglas.
English: The CHMP was concerned that the patients included in the main studies may not have needed hospital treatment using medicines given intravenously (into a vein), so they did not match the types of patients for whom the medicine was intended.
Estonian: Inimravimite komitee ettevaatlikkuse põhjuseks oli asjaolu, et põhiuuringutes osalenud patsientidel ei pruukinud olla vaja haiglaravi koos ravimite intravenoosse (veeni tilgutamise teel) manustamisega; seega ei olnud need patsiendid sellised, kelle jaoks oli ravim ette nähtud.
English: This is a serious type of lung infection that is caught outside of hospital.
Estonian: See on raskekujuline kopsuinfektsioon, mis tekib patsiendil väljaspool haiglat.
English: There are no consequences on the use of Tygacil in the authorised indications, for which the balance of benefits and risks remains unchanged.
Estonian: Tagasivõtmine ei avalda mõju Tygacili kasutamisele nende näidustuste raviks, mille kohta on müügiluba juba antud ning mille korral jääb kasulikkuse ja riski suhe muutumatuks.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tygacil could not have been approved for the treatment of community-acquired pneumonia.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Tygacilile ei või anda keskkonnatekkelise pneumoonia ravis kasutamiseks müügiluba.
English: How is Tygacil expected to work?
Estonian: Milline on Tygacili eeldatav toime?
English: Tygacil is a powder that is made up into a solution for infusion (drip into a vein).
Estonian: Tygacil on pulber, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: Both studies compared Tygacil with levofloxacin (another antibiotic).
Estonian: Mõlemas uuringus võrreldi Tygacili levofloksatsiiniga (samuti antibiootikum).
English: Community-acquired pneumonia is usually caused by infection with bacteria.
Estonian: Keskkonnatekkelist pneumooniat põhjustab tavaliselt bakternakkus.
English: This raised doubts over whether Tygacil would be sufficiently effective in the treatment of patients with severe community-acquired pneumonia.
Estonian: See tekitas kahtlusi, kas Tygacil on ikka piisavalt efektiivne raskekujulise keskkonnatekkelise pneumooniaga patsientide raviks.
English: International non-proprietary name (INN): tigecycline
Estonian: TEAVE MÜÜGILOA MUUTMISTAOTLUSE TAGASIVÕTMISE KOHTA TYGACIL Rahvusvaheline mittekaubanduslik nimetus (INN): tigetsükliin
English: It contains the active substance tigecycline.
Estonian: Selle toimeaine on tigetsükliin.
English: The Committee was also concerned over the number of deaths in patients receiving Tygacil with more serious infections, especially in the study of patients who had caught pneumonia in hospital.
Estonian: Komitee ettevaatlikkuse põhjuseks oli ka surmajuhtude arv patsiendirühmas, kus kasutati Tygacili raskekujulisemate infektsioonide raviks, ning eelkõige nende patsientide uuringus, kel oli pneumoonia tekkinud haiglas.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Tygacil.
Estonian: Ettevõte teatas inimravimite komiteele, et praegu Tygacili kliinilistes uuringutes osalevatele patsientidele tagasivõtmine mõju ei avalda.
English: What is happening for Tygacil for treatment of complicated skin and soft tissue infections and complicated infections in the abdomen?
Estonian: Mis toimub Tygacili kasutamisel naha ja pehmete kudede ning kõhukoopa tüsistunud infektsioonide raviks?
English: The active substance in Tygacil, tigecycline, belongs to the group of antibiotics called ‘glycylcyclines', which are similar to tetracycline.
Estonian: Tygacili toimeaine tigetsükliin kuulub tetratsükliiniga sarnaste antibiootikumide glütsüültsükliinide rühma.