FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and effectiveness of NovoThirteen in children below 6 years of age was supported by preliminary data from an ongoing long-term study during which the patients were given NovoThirteen to prevent bleeding episodes.
Estonian: NovoThirteeni ohutuse ja efektiivsuse toetuseks alla 6-aastastel lastel esitati esialgsed tulemused, mis saadi käimasolevast pikaajalisest uuringust, kus patsientidele anti veritsusepisoodide ennetamiseks NovoThirteeni.
English: NovoThirteen is a medicine that contains the active substance catridecacog.
Estonian: NovoThirteen on ravim, mis sisaldab toimeainena katridekakoogi.
English: For more information about treatment with NovoThirteen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate NovoThirteeniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: NovoThirteen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et NovoThirteeni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: What is the risk associated with NovoThirteen?
Estonian: Mis riskid NovoThirteeniga kaasnevad?
English: In certain situations the doctor may decide to adjust the dose required to prevent bleeding, based on the patient's factor XIII levels in the blood.
Estonian: Teatud olukordades võib arst otsustada kohandada verejooksu ennetamiseks vajalikku annust vastavalt patsiendi XIII hüübimisfaktori sisaldusele veres.
English: NovoThirteen does not work in patients lacking the factor XIII B-subunit.
Estonian: NovoThirteen ei mõju patsientidele, kellel puudub XIII hüübimisfaktori B-allosa.
English: During the long-term study, no bleeding episodes were observed in children below 6 years of age treated with NovoThirteen.
Estonian: Pikaajalises uuringus ei täheldatud NovoThirteeniga ravitud alla 6-aastastel lastel veritsusepisoode.
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 NovoThirteen.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This includes information on storage procedures, since incorrect storage after reconstitution can cause increased levels of activated NovoThirteen, thereby increasing the risk of thrombosis (formation of blood clots in the blood vessels), and information on administration procedures, since the factor XIII concentration in NovoThirteen is different from other factor XIIIcontaining medicines.
Estonian: See hõlmab säilitamisteavet, sest ebaõige säilitamine pärast lahustamist võib põhjustada aktiveeritud NovoThirteeni sisalduse suurenemist ja tromboosi (verehüüvete tekkimine veresoontes) suurenenud riski, ning manustamisteavet, sest XIII hüübimisfaktori kontsentratsioon NovoThirteenis ei ole sama mis teistes XIII hüübimisfaktorit sisaldavates ravimites.
English: The most common side effects with NovoThirteen (seen in between 1 and 10 patients in 100) are headache, leucopenia (low white blood cell counts), aggravated neutropenia (low levels of neutrophils, a type of white blood cell), pain in the extremities, injection site pain, and the presence in the blood of antibodies that attach to factor XIII and of small protein fragments called ‘fibrin D-dimer'.
Estonian: NovoThirteeni kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on peavalu, leukopeenia (vere valgeliblede vähesus), neutropeenia (neutrofiilide e teatud valgeliblede vähesuse) ägenemine, jäsemevalu, valu süstekohal ning XIII hüübimisfaktorile kinnituvate antikehade ja fibriini lagunemisel tekkivate valgufragmentide D-dimeeride esinemine veres.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoThirteen, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele NovoThirteeni ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Patients with congenital factor XIII A-subunit deficiency do not have enough of the factor XIII A-subunit, or it does not work correctly, which makes them prone to bleeding.
Estonian: XIII hüübimisfaktori A-allosa vaegusega patsientidel ei ole piisavalt XIII hüübimisfaktori A-allosa või ei toimi see õigesti, mis põhjustab kalduvust verejooksudeks.
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: NovoThirteeni kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Factor XIII is a protein involved in the blood clotting process.
Estonian: XIII hüübimisfaktor on valk, mis osaleb vere hüübimisprotsessis.
English: Treatment with NovoThirteen should be started under the supervision of a doctor experienced in treating rare bleeding disorders.
Estonian: Ravi NovoThirteeniga peab alustama harvaesinevate hüübimishäirete ravis kogenud arsti järelevalve all.
English: The active substance in NovoThirteen, catridecacog, is structurally the same as the human factor XIII A-subunit.
Estonian: NovoThirteeni toimeaine katridekakoog on samasuguse struktuuriga kui inimese XIII hüübimisfaktori A-allosa.
English: NovoThirteen was investigated in a main study involving 41 adults and children above 6 years of age with congenital factor XIII A-subunit deficiency who had been treated in the past with medicines containing factor XIII.
Estonian: NovoThirteeni uuriti põhiuuringus, milles osales 41 kaasasündinud XIII hüübimisfaktori A-allosa vaegusega täiskasvanut ja üle 6 aasta vanust last, keda oli varem ravitud XIII hüübimisfaktorit sisaldavate ravimitega.
English: What is NovoThirteen?
Estonian: Mis on NovoThirteen?
English: The factor XIII A-subunit in NovoThirteen is made by a method known as ‘recombinant DNA technology': it is produced by yeast cells that have received the gene (DNA) which makes the cells able to produce it.
Estonian: NovoThirteenis sisalduv XIII hüübimisfaktori A-allosa on valmistatud rekombinant-DNA-tehnika abil: seda toodavad pärmirakud, millesse on lisatud selle tootmist võimaldav geen (DNA).
English: Why has NovoThirteen been approved?
Estonian: Miks NovoThirteen heaks kiideti?
English: The patients were given NovoThirteen for one year for preventative use.
Estonian: Patsientidele manustati aasta jooksul ennetava meetmena NovoThirteeni.
English: A specific component of factor XIII called the A-subunit is involved in stabilising blood clots and increasing the strength of the clot.
Estonian: XIII hüübimisfaktori eriline koostisosa (A-allosa) aitab stabiliseerida verehüübeid ja suurendada nende tugevust.
English: This dose is given in a single, slow injection into a vein.
Estonian: Annus manustatakse ühe aeglase veenisisese süstena.
English: It is available as a powder and solvent to be made up into a solution for injection.
Estonian: Seda turustatakse pulbri ja lahustina, millest valmistatakse süstelahus.
English: The study looked at the number of bleeding episodes requiring treatment with a factor XIII-containing medicine in these patients, compared with patients who had not received NovoThirteen, based on earlier data from 16 patients with congenital factor XIII A-subunit deficiency.
Estonian: Uuringus jälgiti patsientidel XIII hüübimisfaktorit sisaldavaid ravimeid vajavate veritsusepisoodide arvu võrreldes patsientidega, kellele ei manustatud NovoThirteeni (uuring põhines kaasasündinud XIII hüübimisfaktori A-allosa vaegusega 16 patsiendi eelnevatel andmetel).
English: NovoThirteen works by providing the factor XIII A-subunit, which helps to prevent bleeding in these patients.
Estonian: NovoThirteen varustab patsienti XIII hüübimisfaktori A-allosaga, mis aitab ennetada verejooksu.
English: The rate of bleeding episodes in patients receiving NovoThirteen preventatively was lower than the rate seen in the earlier data from patients treated on demand with another medicine containing factor XIII.
Estonian: NovoThirteeniga ennetavat ravi saanud patsientidel oli veritsusepisoode vähem kui patsientidel, keda raviti teiste XIII hüübimisfaktorit sisaldavate ravimitega (eelnevate andmete põhjal).
English: On average, there were approximately 0.15 bleeding episodes requiring factor XIII treatment per year per patient treated preventatively with NovoThirteen.
Estonian: NovoThirteeniga ennetavat ravi saanud rühmas esines aastas patsiendi kohta keskmiselt 0,15 veritsusepisoodi, mis vajasid ravi XIII hüübimisfaktoriga, teisi XIII hüübimisfaktorit sisaldavaid ravimeid saanud rühmas aga ligikaudu 2,9 episoodi patsiendi kohta aastas.
English: How does NovoThirteen work?
Estonian: Kuidas NovoThirteen toimib?
English: How has NovoThirteen been studied?
Estonian: Kuidas NovoThirteeni uuriti?
English: What benefit has NovoThirteen shown during the studies?
Estonian: Milles seisneb uuringute põhjal NovoThirteeni kasulikkus?
English: How is NovoThirteen used?
Estonian: Kuidas NovoThirteeni kasutatakse?
English: What is NovoThirteen used for?
Estonian: Milleks NovoThirteeni kasutatakse?
English: NovoThirteen is used for the long-term prevention of bleeding in patients with a condition called ‘congenital factor XIII A-subunit deficiency'.
Estonian: NovoThirteeni kasutatakse pikaajaliseks verejooksude ennetamiseks kaasasündinud XIII hüübimisfaktori A-allosa vaegusega patsientidel.
English: The medicine can only be obtained with a prescription.
Estonian: NovoThirteen on retseptiravim.
English: The recommended dose is one tablet once a week.
Estonian: Soovitatav annus on üks tablett üks kord nädalas.
English: What measures are being taken to ensure the safe and effective use of Vantavo?
Estonian: Mis meetmed võetakse, et tagada Vantavo ohutu ja efektiivne kasutamine?
English: The name of the medicine was changed to Vantavo on 26 March 2010.
Estonian: Ravimi nimetus muudeti 26. märtsil 2010 Vantavoks.
English: A risk management plan has been developed to ensure that Vantavo is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Vantavo võimalikult ohutu kasutamine.
English: The full EPAR for Vantavo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Vantavo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.
Estonian: Tablett tuleb neelata tervelt, seda ei tohi purustada, närida ega lasta suus lahustuda.
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink, or other medicines (including antacids, calcium supplements and vitamins).
Estonian: Patsient peab tableti sisse võtma terve klaasi veega (mitte mineraalveega) vähemalt 30 minutit enne söögi, joogi või muu ravimi (sh antatsiidide, kaltsiumipreparaatide ja vitamiinide) võtmist.
English: The CHMP decided that Vantavo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Vantavo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
English: Other information about Vantavo:
Estonian: Muu teave Vantavo kohta
English: Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight.
Estonian: D3-vitamiin on toitaine, mida sisaldub teatud toiduainetes, kuid seda moodustub ka nahas loodusliku päikesevalguse toimel.
English: For more information about treatment with Vantavo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Vantavoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantavo, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Vantavo omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The European Commission granted a marketing authorisation valid throughout the EU for Alendronate Sodium And Colecalciferol, MSD on 16 October 2009.
Estonian: Euroopa Komisjon andis ravimi Alendronate Sodium And Colecalciferol, MSD müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. oktoobril 2009.
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Vantavo was the same as the dose needed to prevent bone loss.
Estonian: Ettevõtte esitatud teave, mis põhineb varasematel uuringutel ja avaldatud kirjandusel, näitab, et Vantavos sisalduv alendroonhappe kogus on sama kui luukoe hävimise ennetamiseks vajalik kogus.
English: Vantavo 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements.
Estonian: 70 mg/5600 IU Vantavot kasutatakse patsientidel, kes ei võta täiendavat D-vitamiini.
English: 1 Previously known as Alendronate Sodium And Colecalciferol, MSD.
Estonian: 1 Varasem nimetus: Alendronate Sodium And Colecalciferol, MSD.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Vantavo.
Estonian: Et osteoporoosiga patsiendid ei tarvitse saada päikesevalgusega piisavalt D3-vitamiini, sisaldab seda Vantavo.
English: Why has Vantavo been approved?
Estonian: Miks Vantavo heaks kiideti?
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Estonian: Et alendroonhape ja D3-vitamiin on kumbki kasutusel ravimites, millel juba on Euroopa Liidus müügiluba, esitas ettevõte varasematest uuringutest saadud ja kirjanduses avaldatud andmed menopausijärgses eas naiste kohta, kes on kasutanud alendroonhapet ja D3-vitamiini eraldi ravimitena.
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 Vantavo.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Vantavo must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Estonian: Ravimit ei tohi kasutada patsientidel, kellel on söögitoru häired, hüpokaltseemia (kaltsiumivaegus) või kes ei saa vähemalt 30 minutit püsti seista või sirgelt istuda.
English: It is available as tablets (70 mg alendronic acid and 2,800 international units [IU] colecalciferol; 70 mg alendronic acid and 5,600 IU colecalciferol).
Estonian: Ravimit turustatakse tablettidena (70 mg alendroonhapet ja 2800 rahvusvahelist ühikut (IU) kolekaltsiferooli; 70 mg alendroonhapet ja 5600 IU kolekaltsiferooli).
English: The most common side effects with Vantavo include abdominal pain (stomach ache), dyspepsia (heartburn), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
Estonian: Vantavo kõige sagedamad kõrvalnähud on kõhuvalu, düspepsia (kõrvetised), söögitoru haavandid, düsfaagia (neelamisraskus), gaaside kogunemine (kõhu paisumine) ja maohappe tagasivool.
English: Vantavo reduces the risk of broken bones in the spine and the hip.
Estonian: Vantavo vähendab lülisamba ja puusamurdude riski.
English: This document is a summary of the European Public Assessment Report (EPAR) for Vantavo.
Estonian: See on ravimi Vantavo Euroopa avaliku hindamisaruande kokkuvõte.
English: What benefit has Vantavo shown during the studies?
Estonian: Milles seisneb uuringute põhjal Vantavo kasulikkus?
English: What is Vantavo?
Estonian: Mis on Vantavo?
English: Vantavo (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Estonian: Vantavot (2800 IU või 5600 IU kolekaltsiferooli) kasutatakse osteoporoosi (luu-urbnemuse) raviks menopausijärgses eas naistel, kellel on D-vitamiini vaeguse risk.
English: This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Vantavo 70 mg/2,800 IU on its own or adding 2,800 IU vitamin D3 (equivalent to using Vantavo 70 mg/5,600 IU).
Estonian: Uuringut pikendati 652 patsiendil 24 nädala võrra, et võrrelda ravi jätkamist kas üksnes 70 mg/2800 IU Vantavoga või koos lisatud 2800 IU D3-vitamiiniga (võrdväärne 70 mg/5600 IU Vantavo kasutamisega).
English: Vantavo contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Estonian: Vantavo sisaldab kaht toimeainet: alendroonhapet ja kolekaltsiferooli (D3-vitamiin).
English: Patients received either Vantavo 70 mg/2,800 IU or alendronic acid only once a week.
Estonian: Patsiendid said üks kord nädalas kas 70 mg/2800 IU Vantavot või alendroonhapet.
English: How does Vantavo work?
Estonian: Kuidas Vantavo toimib?
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Vantavo's ability to increase vitamin D levels.
Estonian: Alendroonhappe ja D3-vitamiini ühes tabletis kasutamise ja Vantavo mõjul D-vitamiini sisalduse suurenemise toetuseks viis ettevõte läbi uuringu, milles osales 717 osteoporoosiga patsienti, sealhulgas 682 menopausijärgses eas naist.
English: In the extension study, similar numbers of patients taking Vantavo 70 mg/2,800 IU and Vantavo 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Vantavo 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Estonian: Jätku-uuringus oli D-vitamiini vaegusega (alla 6%) patsientide arv samalaadne nii 70 mg/2800 IU kui ka 70 mg/5600 IU Vantavot võtnute seas, kuid 70 mg/5600 IU Vantavot manustanud patsientide D-vitamiini sisaldus suurenes 24 uuringunädala jooksul enam.
English: What is the risk associated with Vantavo?
Estonian: Mis riskid Vantavoga kaasnevad?
English: For the full list of all side effects reported with Vantavo, see the package leaflet.
Estonian: Vantavo kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: the day, which should be at least 30 minutes after taking the tablet.
Estonian: Söögitoru ärritusnähtude vältimiseks tohib patsient pikali heita alles pärast päeva esimest söögikorda, mis peaks olema vähemalt 30 minutit pärast tableti võtmist.
English: Vantavo alendronic acid and colecalciferol
Estonian: alendroonhape ja kolekaltsiferool
English: What is Vantavo used for?
Estonian: Milleks Vantavot kasutatakse?
English: After 15 weeks, fewer patients had low vitamin D levels when they took Vantavo 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Estonian: Vantavot annuses 70 mg/2800 IU manustanud patsientide seas oli 15. nädala järel D-vitamiini vaegusega patsiente vähem (11%) kui ainult alendroonhapet manustanud patsientide seas (32%).
English: How is Vantavo used?
Estonian: Kuidas Vantavot kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Vantavo on retseptiravim.
English: How has Vantavo been studied?
Estonian: Kuidas Vantavot uuriti?
English: Target species Route of administration
Estonian: Nimetus Tugevus Ravimvorm Loomaliigid Manustamisviis Pakend
English: EU Number Invented
Estonian: EL number
English: 9 July 2001
Estonian: 9. juuli 2001
English: Not applicable
Estonian: ei ole kohaldatav
English: See the Module ”All authorised presentations”
Estonian: vt moodulit ”All authorised presentations”
English: Antibacterial for systemic use JO1
Estonian: antibiootikum süsteemseks kasutamiseks JO1
English: Telithromycin
Estonian: telitromütsiin
English: Pharmaco-therapeutic group (ATC Code):
Estonian: Farmakoterapeutiline grupp (ATC-kood):
English: Levviax is indicated for the treatment of the following infections:
Estonian: Levviax on näidustatud järgmiste infektsioonide raviks:
English: differences on the molecular level may exist.
Estonian: makroliidide toimele, kuid molekulaarsel tasandil võib olla erinevusi.
English: Date of issue of Marketing Authorisation valid throughout the European Union:
Estonian: Kogu Euroopa Liidus kehtiva müügiloa väljastamiskuupäev:
English: Aventis Pharma S.A. 20 avenue Raymond Aron F-92160 Antony France
Estonian: 20 avenue Raymond Aron F-92160 Antony Prantsusmaa
English: For detailed conditions for the use of this product, scientific information or procedural aspects please refer to the relevant modules.
Estonian: Üksikasjalikult on preparaadi kasutamise tingimused, teaduslikud andmed ja menetlusega seotud aspektid esitatud asjakohastes moodulites.
English: Adverse events assessed as possibly related to study treatment were reported for 35.8% of the telithromycin patients, versus 28.3% of the comparators.
Estonian: Kõrvaltoimeid, mis võisid hinnangute kohaselt olla seotud uuritava raviga, esines 35,8%-l telitromütsiiniga ravitud patsientidest, võrreldes 28,3%-ga võrreldavate ravimpreparaatide puhul.
English: Telithromycin interacts with the translation at the 23S ribosomal RNA level and some data also indicate that assembly of the 30S subunit may be impaired.
Estonian: Telitromütsiin sekkub translatsiooni 23S ribosoomi RNA tasemel ja mõnede andmete kohaselt võib see blokeerida ka 30S alaühiku koostamist.
English: EMEA/H/C/0355 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Estonian: EMEA/H/C/355 INIMTERVISHOIUS KASUTATAVATE RAVIMITE KOMITEE EUROOPA AVALIK HINDAMISARUANNE (EPAR) LEVVIAX Rahvusvaheline mittekaubanduslik nimetus (INN): telitromütsiin Kokkuvõte
English: Currently approved therapeutic indication(s):
Estonian: Praegu heakskiidetud näidustus(ed):
English: The initial approval was based on studies, which showed that the potential benefits with telithromycin particularly relate to its use in the treatment of infections caused by penicillin and/or erythromycin resistant S. pneumoniae.
Estonian: Esialgne heakskiit põhines uuringute tulemustel, mille kohaselt telitromütsiini potentsiaalne kasulikkus on eelkõige seotud selle kasutamisega infektsioonide ravimiseks, mille põhjuseks on penitsilliinile ja/või erütromütsiinile resistentne S. pneumoniae.
English: The CHMP, on the basis of quality, safety and efficacy data submitted, considers that the benefit risk ratio for Levviax is favourable in the approved indication
Estonian: Inimtervishoius kasutatavate ravimite komitee leidis esitatud kvaliteedi-, ohutuse- ja efektiivsuseandmete põhjal, et Levviax'i kasulikkuse ja riski suhe heakskiidetud näidustuse suhtes on soodne.
English: However, clinical experience is still rather limited in the treatment of these infections, and therefore telithromycin should be used with caution until further experience of emergence of resistance has been gained, especially in areas with a high prevalence of resistant pneumococci.
Estonian: Kliinilised kogemused nende infektsioonide ravist on aga veel küllaltki piiratud, mistõttu telitromütsiini kasutamisel tuleb olla ettevaatlik kuni edasiste kogemuste omandamiseni resistentsuse tekkega, eriti piirkondades, kus esineb palju resistentseid pneumokokke.