FrancophonIA/ELRC3.0 huggingface dataset:
English: Drinking alcohol and taking NovoMix 50
Estonian: NovoMix 50 kasutamine koos alkoholiga
English: 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine SC use
Estonian: 50% lahustuvat aspartinsuliini ja 50% protamiiniga kristalliseeritud aspartinsuliini s.c.
English: 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Estonian: 50% lahustuvat aspartinsuliini ja 50% protamiiniga kristalliseeritud aspartinsuliini
English: Before you use NovoMix 70 Penfill, remove it from the refrigerator.
Estonian: Enne NovoMix 70 Penfill'i kasutamist võtke see külmkapist välja ning segaga nii, nagu seda on soovitatud teha enne esmakordset kasutamist.
English: Before you use NovoMix 50 FlexPen, remove it from the refrigerator.
Estonian: Enne NovoMix 50 FlexPen'i kasutamist võtke see külmkapist välja ning segage nii, nagu seda on soovitatud teha enne esmakordset kasutamist.
English: ► NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
Estonian: ► NovoMix 70 Penfill on ette nähtud üksnes nahaaluseks süstimiseks korduvkasutatava süstevahendiga.
English: Before you use NovoMix 70 FlexPen, remove it from the refrigerator.
Estonian: Enne NovoMix 70 FlexPen'i kasutamist võtke see külmkapist välja ning segage nii, nagu seda on soovitatud teha enne esmakordset kasutamist.
English: NovoMix 30 FlexPen is only suitable for subcutaneous injections.
Estonian: NovoMix 30 FlexPen on ette nähtud üksnes subkutaanseks süstimiseks.
English: NovoMix 30 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Estonian: NovoMix 30 FlexPen on pen-süstel, mis on ette nähtud kasutamiseks koos nõeltega NovoFine või NovoTwist.
English: NovoMix 50 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Estonian: NovoMix 50 manustatakse naha alla reide või kõhupiirkonda.
English: Drinking alcohol and taking NovoMix 70
Estonian: NovoMix 70 kasutamine koos alkoholiga
English: ► NovoMix 70 FlexPen is only suitable for injecting under the skin.
Estonian: ► NovoMix 70 FlexPen on ette nähtud üksnes nahaaluseks süstimiseks.
English: NovoMix 30 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Estonian: NovoMix 30 manustatakse naha alla reide või kõhupiirkonda.
English: During use or when carried as a spare: NovoMix 70 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Estonian: Kasutamise ajal või tagavaraks kaasaskandmisel ei tohi NovoMix 70 Penfill'i hoida külmkapis.
English: Before you use NovoMix 30 Penfill, remove it from the refrigerator.
Estonian: Enne NovoMix 30 Penfill'i kasutamist võtke see külmkapist välja ning segage nii, nagu seda on soovitatud teha enne esmakordset kasutamist.
English: NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Estonian: NovoMix 70 Penfill on ette nähtud kasutamiseks koos Novo Nordiski insuliinisüstevahenditega ja nõeltega NovoFine või NovoTwist.
English: Drinking alcohol and taking NovoMix 30
Estonian: NovoMix 30 kasutamine koos alkoholiga
English: ► NovoMix 50 FlexPen is only suitable for injecting under the skin.
Estonian: ► NovoMix 50 FlexPen on ette nähtud üksnes nahaaluseks süstimiseks.
English: NovoMix 50 FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist needles.
Estonian: NovoMix 50 FlexPen on pen-süstel, mis on ette nähtud kasutamiseks koos nõeltega NovoFine või NovoTwist.
English: During use or when carried as a spare: NovoMix 30 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Estonian: Kasutamise ajal või tagavaraks kaasaskandmisel ei tohi NovoMix 30 FlexPen'i hoida külmkapis.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/142/020 1 pen of 3 ml EU/1/00/142/021 5 pens of 3 ml EU/1/00/142/022 10 pens of 3 ml
Estonian: MÜÜGILOA NUMBRID EU/1/00/142/020 1 pen-süstel x 3 ml EU/1/00/142/021 5 pen-süstlit x 3 ml EU/1/00/142/022 10 pen-süstlit x 3 ml
English: Before you use NovoMix 50 Penfill, remove it from the refrigerator.
Estonian: Enne NovoMix 50 Penfill'i kasutamist võtke see külmkapist välja ning segage nii, nagu seda on soovitatud teha enne esmakordset kasutamist.
English: During use or when carried as a spare: NovoMix 50 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Estonian: Kasutamise ajal või tagavaraks kaasaskandmisel ei tohi NovoMix 50 FlexPen'i hoida külmkapis.
English: 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Estonian: 70% lahustuvat aspartinsuliini ja 30% protamiiniga kristalliseeritud aspartinsuliini
English: ► NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Estonian: ► NovoMix 50 Penfill on ette nähtud üksnes nahaaluseks süstimiseks korduvkasutatava süstevahendiga.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/142/014 1 pen of 3 ml EU/1/00/142/015 5 pens of 3 ml EU/1/00/142/016 10 pens of 3 ml
Estonian: MÜÜGILOA NUMBRID EU/1/00/142/014 1 pen-süstel x 3 ml EU/1/00/142/015 5 pen-süstlit x 3 ml EU/1/00/142/016 10 pen-süstlit x 3 ml
English: Before you use NovoMix 30 FlexPen, remove it from the refrigerator.
Estonian: Enne NovoMix 30 FlexPen'i kasutamist võtke see külmkapist välja ning segage nii, nagu seda on soovitatud teha enne esmakordset kasutamist.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/142/011 1 cartridge of 3 ml EU/1/00/142/012 5 cartridges of 3 ml EU/1/00/142/013 10 cartridges of 3 ml
Estonian: MÜÜGILOA NUMBRID EU/1/00/142/011 1 kolbampull x 3 ml EU/1/00/142/012 5 kolbampulli x 3 ml EU/1/00/142/013 10 kolbampulli x 3 ml
English: ► NovoMix 30 FlexPen is only suitable for injecting under the skin.
Estonian: ► NovoMix 30 FlexPen on ette nähtud üksnes nahaaluseks süstimiseks .
English: Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose.
Estonian: Insuliiniannus võib vajada muutmist kaasneva neeru-, maksa- või neerupealist, ajuripatsit või kilpnääret mõjutava haiguse korral.
English: ► NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Estonian: ► NovoMix 30 Penfill on ette nähtud üksnes nahaaluseks süstimiseks korduvkasutatava süstevahendiga.
English: NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Estonian: NovoMix 30 Penfill on ette nähtud kasutamiseks koos Novo Nordiski insuliinisüstevahenditega ja nõeltega NovoFine või NovoTwist.
English: Before opening: NovoMix 70 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Enne avamist: NovoMix 70 Penfill'i, mida te ei kasuta, peab hoidma külmkapis temperatuuril 2 °C...8 °C, eemal jahutuselemendist.
English: ► There are no restrictions on treatment with NovoMix 70 during breast-feeding.
Estonian: ► Imetamise ajal ei ole piiranguid NovoMix 70 kasutamiseks.
English: NovoMix 50 Penfill 100 units/ml suspension for injection in a cartridge 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Estonian: NovoMix 50 Penfill 100 ühikut/ml süstesuspensioon kolbampullis 50% lahustuvat aspartinsuliini ja 50% protamiiniga kristalliseeritud aspartinsuliini
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 50/50 (equivalent to 3.5 mg).
Estonian: 1 ml suspensiooni sisaldab 100 ühikut lahustuvat aspartinsuliini/protamiiniga kristalliseeritud aspartinsuliini suhtes 50/50 (vastab 3,5 mg-le).
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 50/50 (equivalent to 3.5 mg).
Estonian: 1 ml suspensiooni sisaldab 100 ühikut lahustuvat aspartinsuliini*/protamiiniga kristalliseeritud aspartinsuliini* suhtes 50/50 (vastab 3,5 mg-le).
English: NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Estonian: NovoMix 50 Penfill on ette nähtud kasutamiseks koos Novo Nordiski insuliinisüstevahenditega ja nõeltega NovoFine või NovoTwist.
English: 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine SC use
Estonian: 70% lahustuvat aspartinsuliini ja 30% protamiiniga kristalliseeritud aspartinsuliini s.c.
English: 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine SC use
Estonian: 30% lahustuvat aspartinsuliini ja 70% protamiiniga kristalliseeritud aspartinsuliini s.c.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 30 Penfill 100 units/ml suspension for injection in cartridge NovoMix 30 FlexPen 100 units/ml suspension for injection in pre-filled pen
Estonian: NovoMix 30 Penfill 100 ühikut/ml süstesuspensioon kolbampullis NovoMix 30 FlexPen 100 ühikut/ml süstesuspensioon pen-süstlis
English: Before opening: NovoMix 30 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Enne avamist: NovoMix 30 FlexPen'i, mida te ei kasuta, peab hoidma külmkapis temperatuuril 2 °C...8 °C, eemal jahutuselemendist.
English: During use or when carried as a spare: NovoMix 30 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Estonian: Kasutamise ajal või tagavaraks kaasaskandmisel ei tohi NovoMix 30 Penfill'i hoida külmkapis.
English: During use or when carried as a spare: NovoMix 50 Penfill that is being used or carried as a spare should not be kept in the refrigerator.
Estonian: Kasutamise ajal või tagavaraks kaasaskandmisel ei tohi NovoMix 50 Penfill'i hoida külmkapis.
English: NovoMix 70 Penfill is only suitable for subcutaneous injections from a reusable pen.
Estonian: NovoMix 70 Penfill on ette nähtud üksnes subkutaanseks süstimiseks koos korduvkasutatava süstevahendiga.
English: 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Estonian: 30% lahustuvat aspartinsuliini ja 70% protamiiniga kristalliseeritud aspartinsuliini
English: Before opening: NovoMix 50 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Enne avamist: NovoMix 50 FlexPen'i, mida te ei kasuta, peab hoidma külmkapis temperatuuril 2 °C...8 °C, eemal jahutuselemendist.
English: 1 cartridge contains 3 ml equivalent to 300 units
Estonian: 1 kolbampull sisaldab 3 ml, mis vastab 300 ühikule;
English: Nervous system disorders
Estonian: annustamisrežiimide ja glükeemilise kontrolliga.
English: NovoMix 70 FlexPen is only suitable for injecting under the skin.
Estonian: NovoMix 70 FlexPen on ette nähtud üksnes nahaaluseks süstimiseks.
English: Pack sizes of 1, 5 and 10 cartridges of 3 ml.
Estonian: Pakendi suurused: 3 ml kolbampullid 1, 5 ja 10 kaupa.
English: ► Needles and NovoMix 50 Penfill must not be shared.
Estonian: ► Nõelad ja NovoMix 50 on individuaalseks kasutamiseks.
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Estonian: Kui olete rase või imetate, pidage enne ükskõik millise ravimi kasutamist nõu oma arsti,meditsiiniõe või apteekriga.
English: NovoMix 50 FlexPen is only suitable for injecting under the skin.
Estonian: NovoMix 50 FlexPen on ette nähtud üksnes nahaaluseks süstimiseks.
English: Before opening: NovoMix 30 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Enne avamist: NovoMix 30 Penfill'i, mida te ei kasuta, peab hoidma külmkapis temperatuuril 2 °C...8 °C, eemal jahutuselemendist.
English: Before opening: NovoMix 50 Penfill that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Enne avamist: NovoMix 50 Penfill'i, mida te ei kasuta, peab hoidma külmkapis temperatuuril 2 °C...8 °C, eemal jahutuselemendist.
English: Only use resuspension if uniformly white, cloudy and aqueous For use by one person only
Estonian: Kasutada ainult ühtlaselt valget ja hägusat vesisuspensiooni.
English: ► There are no restrictions on treatment with NovoMix 50 during breast-feeding.
Estonian: ► Imetamise ajal ei ole piiranguid NovoMix 50 kasutamiseks.
English: NovoMix 30 Penfill 100 units/ml suspension for injection in a cartridge 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Estonian: NovoMix 30 Penfill 100 ühikut/ml süstesuspensioon kolbampullis 30% lahustuvat aspartinsuliini ja 70% protamiiniga kristalliseeritud aspartinsuliini
English: This is called acute painful neuropathy and is usually transient.
Estonian: Kui teie veresuhkru tase paraneb väga kiiresti, siis võib tekkida närvidega seotud valu, mida nimetatakse akuutseks valulikuks neuropaatiaks ning mis on enamasti mööduv.
English: Protamine sulfate
Estonian: Protamiinsulfaat
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70 (equivalent to 3.5 mg).
Estonian: 1 ml suspensiooni sisaldab 100 ühikut lahustuvat aspartinsuliini/protamiiniga kristalliseeritud aspartinsuliini suhtes 30/70 (vastab 3,5 mg-le).
English: ► NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Estonian: ► Kolbampullid NovoMix 50 Penfill on ette nähtud kasutamiseks koos Novo Nordiski insuliinisüstevahendite ja nõeltega NovoFine või NovoTwist.
English: NovoMix 30 Penfill is only suitable for subcutaneous injections from a reusable pen.
Estonian: NovoMix 30 Penfill on ette nähtud üksnes subkutaanseks süstimiseks koos korduvkasutatava süstevahendiga.
English: Each pre-filled pen contains 300 units of insulin aspart in 3 ml suspension for injection.
Estonian: Üks pen-süstel sisaldab 3 ml süstesuspensiooni, mis vastab 300 ühikut aspartinsuliinile.
English: Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and aqueous.
Estonian: Ärge kasutage süstevahendit, kui resuspendeeritud insuliin ei ole ühtlaselt valge ja hägune vesisuspensioon.
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 30/70 (equivalent to 3.5 mg).
Estonian: 1 ml suspensiooni sisaldab 100 ühikut lahustuvat aspartinsuliini*/protamiiniga kristalliseeritud aspartinsuliini* suhtes 30/70 (vastab 3,5 mg-le).
English: NovoMix 50 Penfill is only suitable for subcutaneous injections from a reusable pen.
Estonian: NovoMix 50 Penfill on ette nähtud üksnes subkutaanseks süstimiseks koos korduvkasutatava süstevahendiga.
English: 1 ml of the suspension contains 100 units soluble insulin aspart*/protamine-crystallised insulin aspart* in the ratio 70/30 (equivalent to 3.5 mg).
Estonian: 1 ml suspensiooni sisaldab 100 ühikut lahustuvat aspartinsuliini*/protamiiniga kristalliseeritud aspartinsuliini* suhtes 70/30 (vastab 3,5 mg-le).
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 70/30 (equivalent to 3.5 mg).
Estonian: 1 ml suspensiooni sisaldab 100 ühikut lahustuvat aspartinsuliini/protamiiniga kristalliseeritud aspartinsuliini suhtes 70/30 (vastab 3,5 mg-le).
English: ► There are no restrictions on treatment with NovoMix 30 during breast-feeding.
Estonian: ► Imetamise ajal ei ole piiranguid NovoMix 30 kasutamiseks.
English: These usually disappear after a few weeks of taking your insulin.
Estonian: Tavaliselt kaovad sellised nähud paari nädala jooksul.
English: Do not use the cartridge if the resuspended insulin does not look uniformly white and cloudy.
Estonian: Ärge kasutage kolbampulli, kui vesisuspensioon ei ole ühtlaselt valge ja hägune.
English: NovoMix 30 FlexPen is only suitable for injecting under the skin.
Estonian: NovoMix 30 FlexPen on ette nähtud üksnes nahaaluseks süstimiseks .
English: ► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Estonian: ► Kolbampullid NovoMix 70 Penfill on ette nähtud kasutamiseks koos Novo Nordiski süstevahendite ja nõeltega NovoFine või NovoTwist.
English: NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Estonian: NovoMix 50 Penfill on ette nähtud üksnes nahaaluseks süstimiseks korduvkasutatava süstevahendiga.
English: 1 pre-filled pen contains 3 ml equivalent to 300 units
Estonian: 1 pen-süstel sisaldab 3 ml, mis vastab 300 ühikule;
English: Each cartridge contains 300 units of insulin aspart in 3 ml suspension for injection.
Estonian: Üks kolbampull sisaldab 3 ml süstesuspensiooni, mis vastab 300 ühikut aspartinsuliinile.
English: When NovoMix 50 is used in combination with metformin the dose should be adjusted.
Estonian: Annust tuleb täpsustada, kui NovoMix 50 kasutatakse koos metformiiniga.
English: ► Needles and NovoMix 70 Penfill must not be shared.
Estonian: ► Nõelad ja NovoMix 70 on individuaalseks kasutamiseks.
English: ► After each injection, be sure to remove and discard the needle and store NovoMix 50 without the needle attached.
Estonian: Pärast iga süstimist eemaldage alati nõel ja hoidke FlexPen'i ilma nõelata.
English: ► NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Estonian: ► Kolbampullid NovoMix 30 Penfill on ette nähtud kasutamiseks koos Novo Nordiski süstevahendite ja nõeltega NovoFine või NovoTwist.
English: When NovoMix 70 is used in combination with metformin the dose should be adjusted.
Estonian: Annust tuleb täpsustada, kui NovoMix 70 kasutatakse koos metformiiniga.
English: During use or when carried as a spare: NovoMix 70 FlexPen that is being used or carried as a spare should not be kept in the refrigerator.
Estonian: Kasutamise ajal või tagavaraks kaasaskandmisel ei tohiNovoMix 70 FlexPen'i hoida külmkapis.
English: NovoMix 70 is presented as a suspension for injection in a pre-filled pen.
Estonian: NovoMix 70 on valge süstesuspensioon pen-süstlis.
English: • There is limited experience with NovoMix 30 in children aged 6-9 years.
Estonian: • Kasutamise kogemus 6…9-aastastel lastel on piiratud.
English: 15 April 2014 EMA/235924/2014
Estonian: 15. aprill 2014 EMA/235924/2014
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Estonian: Tel. +44 (0)20 3660 8427 E-post: press@ema.europa.eu
English: • If you have any questions, speak to your doctor or pharmacist.
Estonian: • Kui teil on küsimusi, pidage nõu oma arsti või apteekriga.
English: Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures.
Estonian: Lisaks peab ettevõte korraldama lisauuringuid, et näidata uute meetmete tõhusust.
English: The review of Protelos/Osseor was initiated in May 2013 at the request of European Commission under Article 20 of Regulation (EC) No 726/2004.
Estonian: Euroopa Komisjoni algatas 2013. aasta mais ravimite Protelos/Osseor määruse (EÜ) nr 726/2004 artikli 20 kohase läbivaatamise.
English: The results showed an increased risk of myocardial infarction with Protelos/Osseor as compared with placebo (1.7% versus 1.1 %), with a relative risk of 1.6 (95% CI, 1.07 to 2.38), and an increased risk of venous thrombotic and embolic events - 1.9% versus 1.3 % with a relative risk of 1.5 (95% CI, 1.04 to 2.19).
Estonian: Nende tulemuste põhjal suurenes Protelose/Osseori kasutamisel platseeboga võrreldes südamelihaseinfarkti risk (vastavalt 1,7% ja 1,1%), suhteline risk 1,6 (95% usaldusvahemik, 1,07 kuni 2,38), ja venoossete trombembooliate juhtumite risk: vastavalt 1,9% ja 1,3%, suhteline risk 1,5 (95% usaldusvahemik, 1,04 kuni 2,19).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom should remain an option for patients with no history of cardiovascular disease who cannot take other medicines.
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom nendele patsientidele, kellel ei ole varem esinenud kardiovaskulaarseid haigusi ja kes ei saa teisi ravimeid võtta.
English: The patient's risk of developing cardiovascular disease should be evaluated before starting treatment and on a regular basis thereafter, generally every 6 to 12 months;
Estonian: Patsiendi kardiovaskulaarse haiguse tekke riski tuleb hinnata enne ravi alustamist ja seejärel regulaarselt, tavaliselt iga 6 kuni 12 kuu järel.
English: Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine.
Estonian: Riski minimeerimise lisameetmed hõlmavad ka teabematerjale ravimit määravatele arstidele tagamaks, et ravimit võtavad ainult sobivad patsiendid.
English: • Before starting treatment, your doctor will assess your risk of heart disease and high blood pressure and continue to check your risk at regular intervals during treatment.
Estonian: • Enne ravi alustamist hindab arst südamehaiguste ja kõrge vererõhu riski ning kontrollib seda riski ravi jooksul regulaarsete ajavahemike järel.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 15 April 2014.
Estonian: Inimravimite komitee arvamus edastati Euroopa Komisjonile, kes selle kinnitas ja andis 15. aprillil 2014 välja õiguslikult siduva lõpliku otsuse, mis kehtib kogu Euroopa Liidus.
English: 'The PRAC will continue to monitor the safety of Protelos /Osseor and the effectiveness of risk minimisation in long term use.'
Estonian: „Ravimiohutuse riskihindamiskomitee jätkab Protelose/Osseori ohutuse jälgimist ja riski minimeerimise meetmete tõhusust pikaajalise kasutuse korral.”
English: In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Estonian: Lisaks tuleb Protelose/Osseoriga ravitavaid patsiente jälgida regulaarselt iga 6 kuni 12 kuu tagant.
English: Both committees worked in close collaboration and the PRAC's recommendation was instrumental for us to fully assess the benefit-risk profile of the medicine', said Tomas Salmonson, chair of the CHMP.
Estonian: Komiteed tegid tihedat koostööd ja ravimiohutuse riskihindamiskomitee aitas meil ravimi kasulikkuse ja riski profiili täielikult hinnata,” ütles inimravimite komitee esimees Tomas Salmonson.
English: The current recommendations add to EMA recommendations made in April 2013 not to use Protelos/Osseor in patients with known circulatory problems.
Estonian: Siin toodud soovitused lisatakse EMA 2013. aasta aprilli soovitustele mitte kasutada ravimeid Protelos/Osseor patsientidel, kellel on teadaolevad veresoonkonna probleemid.
English: 'The PRAC has worked closely with the CHMP throughout the procedure and while we acknowledge that the recommendations of the two committees differed, our understanding of the medicine's benefit-risk profile is closely aligned and we share a common view of the importance of effective monitoring of cardiovascular risk', said June Raine, chair of the PRAC.
Estonian: „Ravimiohutuse riskihindamiskomitee on kogu menetluse käigus inimravimite komiteega tihedat koostööd teinud ja kuigi tunnistame, et kahe komitee soovitused on erinevad, oleme üksmeelel ravimite kasulikkuse ja riski profiili suhtes ning mõlemad komiteed peavad oluliseks kardiovaskulaarse riski tõhusat jälgimist,” ütles ravimiohutuse riskihindamiskomitee esinaine June Raine.
English: 'However, the CHMP considered that, for patients who have no alternative treatment, regular screening and monitoring to exclude cardiovascular disease will sufficiently reduce the risk identified by the PRAC so that these patients can continue to have access to the medicine.'
Estonian: „Inimravimite komitee jõudis aga järeldusele, et patsientidel, kelle puhul ei ole muu ravi võimalik, vähendab regulaarne jälgimine kardiovaskulaarsete haiguste välistamiseks ravimiohutuse riskihindamiskomitee tuvastatud riskide esinemist piisavalt, nii et need patsiendid saavad jätkuvalt seda ravimit võtta.”