FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended to resuspend the insulin as instructed every time you use a new pen.
Latvian: Insulīnu ir ieteicams saskalot, kā norādīts par katru reizi, kad lietojat jaunu pilnšļirci.
English: NovoMix 50 FlexPen 100 units/ml suspension for injection in a pre-filled pen 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Latvian: NovoMix 50 FlexPen 100 vienības/ml Suspensija injekcijām pildspalvveida pilnšļircē 50% šķīstoša asparta insulīna un 50% kristalizēta protamīna asparta insulīna
English: NovoMix 30 is presented as a suspension for injection in a pre-filled pen.
Latvian: NovoMix 30 ir suspensija injekcijām pildspalvveida pilnšļircē.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 70 Penfill 100 units/ml
Latvian: ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS NovoMix 70 Penfill 100 vienības/ml
English: Do not use the pen if the resuspended insulin does not look uniformly white, cloudy and aqueous.
Latvian: Nelietojiet pilnšļirci, ja saskalotais insulīns nav vienmērīgi balta un duļķaina ūdens suspensija.
English: NovoMix 30 is administered subcutaneously by injection in the thigh or in the abdominal wall.
Latvian: NovoMix 30 ievada subkutānas injekcijas veidā augšstilbā vai vēdera priekšējā sienā.
English: Suspension for injection in pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Latvian: Suspensija injekcijām kārtridžā 30% šķīstoša asparta insulīna un 70% kristalizēta protamīna asparta insulīna
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
Latvian: 12. REĢISTRĀCIJAS APLIECĪBAS NUMURI EU/1/00/142/020 1 pilnšļirce pa 3 ml EU/1/00/142/021 5 pilnšļirces pa 3 ml EU/1/00/142/022 10 pilnšļirces pa 3 ml
English: Posology
Latvian: Uzgalis
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Latvian: Ja Jums iestājusies grūtniecība vai barojat bērnu ar krūti, pirms jebkuru zāļu lietošanas konsultējieties ar ārstu vai farmaceitu.
English: ► NovoMix 70 FlexPen is only suitable for injecting under the skin.
Latvian: ► NovoMix 70 FlexPen ir piemērota tikai injicēšanai zem ādas.
English: NovoMix 50 Penfill EU/1/00/142/011 EU/1/00/142/012 EU/1/00/142/013
Latvian: EU/1/00/142/012 EU/1/00/142/013
English: ► Needles and NovoMix 50 Penfill must not be shared.
Latvian: ► Adatas un NovoMix 50 Penfill ir paredzēti tikai individuālai lietošanai.
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
Latvian: 12. REĢISTRĀCIJAS APLIECĪBAS NUMURI EU/1/00/142/014 1 pilnšļirce pa 3 ml EU/1/00/142/015 5 pilnšļirces pa 3 ml EU/1/00/142/016 10 pilnšļirces pa 3 ml
English: NovoMix 50 Penfill 100 units/ml suspension for injection in a cartridge 50% soluble insulin aspart and 50% insulin aspart crystallised with protamine
Latvian: NovoMix 50 Penfill 100 vienības/ml suspensija injekcijām kārtridžā 50% šķīstoša asparta insulīna (insulinum aspartum) un 50% kristalizēta protamīna asparta insulīna
English: ► NovoMix 50 FlexPen is only suitable for injecting under the skin.
Latvian: ► NovoMix 50 FlexPen ir piemērota tikai injicēšanai zem ādas.
English: The remaining 30% is in crystalline form as protamine-crystallised insulin aspart; this has a prolonged absorption profile similar to human NPH insulin.
Latvian: Atlikušie 30% ir kristāliskā formā kā kristalizēts protamīna asparta insulīns; tas uzsūcas lēnāk, līdzīgi kā cilvēka NPH insulīns.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 50 Penfill 100 units/ml suspension for injection in cartridge NovoMix 50 FlexPen 100 units/ml suspension for injection in pre-filled pen
Latvian: ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS NovoMix 50 FlexPen 100 vienības/ml Suspensija injekcijām
English: NAME OF THE MEDICINAL PRODUCT NovoMix 70 Penfill 100 units/ml suspension for injection in cartridge NovoMix 70 FlexPen 100 units/ml suspension for injection in pre-filled pen
Latvian: ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS NovoMix 70 FlexPen 100 vienības/ml Suspensija injekcijām
English: NovoMix 50 FlexPen is only suitable for injecting under the skin.
Latvian: NovoMix 50 FlexPen ir piemērota tikai injicēšanai zem ādas.
English: If you take the wrong type of insulin, your blood sugar level may get too high or too low.
Latvian: Ja ievadīsiet nepareizo insulīnu, tas var radīt pārāk augstu vai pārāk zemu glikozes līmenis Jūsu asinīs.
English: ► NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
Latvian: ► NovoMix 70 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu pildspalvveida šļirci.
English: What NovoMix 50 looks like and contents of the pack
Latvian: NovoMix 50 ārējais izskats un iepakojums
English: ► NovoMix 30 FlexPen is only suitable for injecting under the skin.
Latvian: ► NovoMix 30 FlexPen ir piemērota tikai injicēšanai zem ādas.
English: NAME OF THE MEDICINAL PRODUCT NovoMix 50 Penfill 100 units/ml
Latvian: ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS NovoMix 50 Penfill 100 vienības/ml
English: NovoMix 70 FlexPen is only suitable for injecting under the skin.
Latvian: NovoMix 70 FlexPen ir piemērota tikai injicēšanai zem ādas.
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 50/50 (equivalent to 3.5 mg).
Latvian: 1 ml suspensijas satur 100 vienības šķīstoša asparta insulīna/kristalizēta protamīna asparta insulīna attiecībā 50/50 (atbilst 3,5 mg),
English: ► Needles and NovoMix 30 Penfill must not be shared.
Latvian: Adatas un NovoMix 30 Penfill ir paredzēti tikai individuālai lietošanai.
English: NovoMix 30 dose adjustment
Latvian: NovoMix 30 satur nātriju
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.
Latvian: Lietošanas laikā vai nēsājot līdzi rezervei: NovoMix 70 FlexPen, ko pašreiz lietojat vai nēsājiet līdzi rezervei, nav jāuzglabā ledusskapī.
English: ► NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Latvian: ► NovoMix 50 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu pildspalvveida šļirci.
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).
Latvian: 1 ml suspensijas satur 100 vienības šķīstoša asparta insulīna (insulinum aspartum)*/kristalizēta protamīna asparta insulīna* attiecībā 50/50 (atbilst 3,5 mg).
English: Needles, cartridges and pre-filled pens must not be shared.
Latvian: Adatas, kārtridži un pildspalvveida pilnšļirces ir paredzētas tikai individuālai lietošanai.
English: NovoMix 30 FlexPen is only suitable for injecting under the skin.
Latvian: NovoMix 30 FlexPen ir piemērota tikai injicēšanai zem ādas.
English: Before opening: NovoMix 70 FlexPen that is not being used must be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Latvian: Pirms atvēršanas: NovoMix 70 FlexPen, kas netiek lietota, jāuzglabā ledusskapī (2°C - 8°C), atstatus no saldētavas nodalījuma.
English: ► NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Latvian: ► NovoMix 30 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu pildspalvveida šļirci.
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.
Latvian: Lietošanas laikā vai nēsājot līdzi rezervei: NovoMix 70 Penfill, ko pašeiz lietojat vai nēsājat līdzi rezervei, nav jāuzglabā ledusskapī.
English: NovoMix 70 Penfill EU/1/00/142/017 EU/1/00/142/018 EU/1/00/142/019
Latvian: EU/1/00/142/018 EU/1/00/142/019
English: NovoMix 70 FlexPen 100 units/ml suspension for injection in a pre-filled pen 70% soluble insulin aspart and 30% insulin aspart crystallised with protamine
Latvian: NovoMix 70 FlexPen 100 vienības/ml Suspensija injekcijām pildspalvveida pilnšļircē 70% šķīstoša asparta insulīna un 30% kristalizēta protamīna asparta insulīna
English: Making the injection
Latvian: Ūdens injekcijām
English: NovoMix 70 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Latvian: NovoMix 70 Penfill ir paredzēts lietošanai ar Novo Nordisk insulīna ievadīšanas ierīcēm un NovoFine vai NovoTwist adatām.
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.
Latvian: Lietošanas laikā vai nēsājot līdzi rezervei: NovoMix 50 FlexPen, ko pašreiz lietojat vai nēsājat līdzi rezervei, nav jāuzglabā ledusskapī.
English: NovoMix 70 Penfill is only suitable for injecting under the skin using a reusable pen.
Latvian: NovoMix 70 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu pildspalvveida šļirci.
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.
Latvian: Pirms atvēršanas: NovoMix 70 Penfill, kas netiek lietots, jāuzglabā ledusskapī (2°C - 8°C), atstatus no saldētavas nodalījuma.
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.
Latvian: Lietošanas laikā vai nēsājot līdzi rezervei: NovoMix 30 Penfill, ko pašeiz lietojat vai nēsājat līdzi rezervei, nav jāuzglabā ledusskapī.
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.
Latvian: Pirms atvēršanas: NovoMix 50 FlexPen, kas netiek lietota, jāuzglabā ledusskapī (2°C - 8°C), atstatus no saldētavas nodalījuma.
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.
Latvian: Pirms atvēršanas: NovoMix 30 FlexPen, kas netiek lietota, jāuzglabā ledusskapī (2°C - 8°C), atstatus no saldētavas nodalījuma.
English: Pregnancy
Latvian: Lipodistrofija
English: NovoMix 30 Penfill is only suitable for injecting under the skin using a reusable pen.
Latvian: NovoMix 30 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu pildspalvveida šļirci.
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.
Latvian: Lietošanas laikā vai nēsājot līdzi rezervei: NovoMix 30 FlexPen, ko pašreiz lietojat vai nēsājiet līdzi rezervei, nav jāuzglabā ledusskapī.
English: NovoMix 50 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Latvian: NovoMix 50 Penfill ir paredzēts lietošanai ar Novo Nordisk insulīna ievadīšanas ierīcēm un NovoFine vai NovoTwist adatām.
English: NovoMix 30 Penfill 100 units/ml suspension for injection in a cartridge 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Latvian: NovoMix 30 Penfill 100 vienības/ml suspensija injekcijām kārtridžā 30% šķīstoša asparta insulīna (insulinum aspartum) un 70% kristalizēta protamīna asparta insulīna
English: NovoMix 30 Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Latvian: NovoMix 30 Penfill ir paredzēts lietošanai ar Novo Nordisk insulīna ievadīšanas ierīcēm un NovoFine vai NovoTwist adatām.
English: Pack sizes of 1, 5 and 10 cartridges.
Latvian: Iepakojuma lielumi ir 1 vai 5, vai 10 kārtridži.
English: NovoMix 50 Penfill is only suitable for injecting under the skin using a reusable pen.
Latvian: NovoMix 50 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu pildspalvveida šļirci.
English: NovoMix 30 FlexPen 100 units/ml suspension for injection in a pre-filled pen 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine
Latvian: NovoMix 30 FlexPen 100 vienības/ml suspensija injekcijām pildspalvveida pilnšļircē 30% šķīstoša asparta insulīna (insulinum aspartum) un 70% kristalizēta protamīna asparta insulīna
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.
Latvian: Lietošanas laikā vai nēsājot līdzi rezervei: NovoMix 50 Penfill, ko pašeiz lietojat vai nēsājat līdzi rezervei, nav jāuzglabā ledusskapī.
English: Do not use NovoMix 50
Latvian: Nelietojiet NovoMix 50 šādos gadījumos
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.
Latvian: Pirms atvēršanas: NovoMix 30 Penfill, kas netiek lietots, jāuzglabā ledusskapī (2°C - 8°C), atstatus no saldētavas nodalījuma.
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.
Latvian: Pirms atvēršanas: NovoMix 50 Penfill, kas netiek lietots, jāuzglabā ledusskapī (2°C - 8°C), atstatus no saldētavas nodalījuma.
English: Resuspending your insulin
Latvian: Insulīna saskalošana
English: Resuspension of NovoMix 50
Latvian: NovoMix 50 saskalošana
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70 (equivalent to 3.5 mg).
Latvian: 1 ml suspensijas satur 100 vienības šķīstoša asparta insulīna/kristalizēta protamīna asparta insulīna attiecībā 30/70 (atbilst 3,5 mg),
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
Latvian: NovoMix 30 FlexPen 100 vienības/ml suspensija injekcijām pildspalvveida pilnšļircē.
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).
Latvian: 1 ml suspensijas satur 100 vienības šķīstoša asparta insulīna (insulinum aspartum)*/kristalizēta protamīna asparta insulīna* attiecībā 30/70 (atbilst 3,5 mg).
English: 1 ml suspension contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 70/30 (equivalent to 3.5 mg).
Latvian: 1 ml suspensijas satur 100 vienības šķīstoša asparta insulīna/kristalizēta protamīna asparta insulīna attiecībā 70/30 (atbilst 3,5 mg),
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).
Latvian: 1 ml suspensijas satur 100 vienības šķīstoša asparta insulīna (insulinum aspartum)*/kristalizēta protamīna asparta insulīna* attiecībā 70/30 (atbilst 3,5 mg).
English: ► NovoMix 70 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Latvian: NovoMix 70 Penfill kārtridži ir paredzēti lietošanai kopā ar Novo Nordisk insulīna ievadīšanas ierīcēm un NovoFine vai NovoTwist adatām.
English: NovoMix 70 Penfill is only suitable for subcutaneous injections from a reusable pen.
Latvian: NovoMix 70 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu insulīna pildspalvveida šļirci.
English: Do not use NovoMix 70
Latvian: Nelietojiet NovoMix 70 šādos gadījumos
English: ► NovoMix 50 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Latvian: NovoMix 50 Penfill kārtridži ir paredzēti lietošanai kopā ar Novo Nordisk insulīna ievadīšanas ierīcēm un NovoFine vai NovoTwist adatām.
English: NovoMix 30 Penfill is only suitable for subcutaneous injections from a reusable pen.
Latvian: NovoMix 30 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu insulīna pildspalvveida šļirci.
English: This makes it easier to resuspend.
Latvian: Tas padarīs vieglāku insulīna saskalošanu.
English: What NovoMix 30 looks like and contents of the pack
Latvian: NovoMix 30 ārējais izskats un iepakojums
English: Do not use NovoMix 30
Latvian: Nelietojiet NovoMix 30 šādos gadījumos
English: OTHER SPECIAL WARNINGS, IF NECESSARY Resuspend according to instructions Only use resuspension if uniformly white, cloudy and aqueous.
Latvian: CITI ĪPAŠI BRĪDINĀJUMI, JA NEPIECIEŠAMS Saskalot, ievērojot norādījumus.
English: Discard the needle after each injection
Latvian: Pēc katras injekcijas izmetiet lietoto adatu.
English: ► NovoMix 30 Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Latvian: NovoMix 30 Penfill kārtridži ir paredzēti lietošanai kopā ar Novo Nordisk insulīna ievadīšanas ierīcēm un NovoFine vai NovoTwist adatām.
English: Drinking alcohol and taking NovoMix 30
Latvian: NovoMix 30 kopā ar alkoholu
English: NovoMix 70 Penfill and NovoMix 70 FlexPen:
Latvian: NovoMix 70 Penfill un NovoMix 70 FlexPen: Novo Nordisk A/S
English: NovoMix 50 Penfill is only suitable for subcutaneous injections from a reusable pen.
Latvian: NovoMix 50 Penfill ir piemērots tikai injicēšanai zem ādas ar atkārtoti lietojamu insulīna pildspalvveida šļirci.
English: Marketing Authorisation Holder
Latvian: Reģistrācijas apliecības īpašnieks:
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Latvian: LIETOŠANAS UN IEVADĪŠANAS VEIDS Pirms lietošanas izlasiet instrukciju.
English: 15 April 2014 EMA/235924/2014
Latvian: 2014. gada 15. aprīlis EMA/235924/2014
English: • If you have any questions, speak to your doctor or pharmacist.
Latvian: • Ja Jums rodas kādi jautājumi, vaicājiet ārstam vai farmaceitam.
English: More information can be found here.
Latvian: Sīkāka informācija ir pieejama šeit.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Latvian: Tālr. +44 (0)20 3660 8427 E-pasts: press@ema.europa.eu
English: Importantly, the company is required to conduct further research to demonstrate the effectiveness of the new measures.
Latvian: Svarīgi, ka uzņēmumam ir lūgts veikt papildu pētījumus, lai pierādītu jauno pasākumu efektivitāti.
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.
Latvian: Protelos/Osseor lietas pārskatīšanu sāka 2013. gada maijā pēc Eiropas Komisijas lūguma saskaņā ar Regulas (EK) Nr. 726/2004 20. pantu.
English: Protelos/Osseor to remain available but with further restrictions
Latvian: Protelos/Osseor paliek pieejami, bet ar papildu ierobežojumiem
English: Further information on the PRAC recommendation and the background to this review can be found on Agency's website.
Latvian: Sīkāka informācija par PRAC ieteikumu un šīs pārskatīšanas pamatojums ir atrodams Aģentūras tīmekļa vietnē.
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).
Latvian: Rezultāti liecināja par paaugstinātu miokarda infarkta risku, lietojot Protelos/Osseor, salīdzinājumā ar placebo (1,7 %, salīdzinot ar 1,1 %), relatīvais risks 1,6 (95 % TI, no 1,07 līdz 2,38), un paaugstinātu venozu trombotisku un embolisku traucējumu risku - 1,9 %, salīdzinot ar 1,3 %, relatīvais risks 1,5 (95 % TI, no 1,04 līdz 2,19).
English: 'The PRAC will continue to monitor the safety of Protelos /Osseor and the effectiveness of risk minimisation in long term use.'
Latvian: "PRAC turpinās uzraudzīt Protelos /Osseor drošumu un riska mazināšanas efektivitāti ilgstošas lietošanas gadījumā."
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.
Latvian: • Pirms ārstēšanas uzsākšanas ārsts Jums novērtēs sirds slimības un paaugstināta asinsspiediena risku un turpinās pārbaudīt Jūsu risku regulāri ārstēšanas laikā.
English: Additional risk minimisation measures include providing educational material to prescribers to ensure that only the appropriate patients are treated with the medicine.
Latvian: Papildu riska mazināšanas pasākumi ietver izglītojošu materiālu izsniegšanu zāļu parakstītājiem, lai nodrošinātu, ka ar šī zālēm tiek ārstēti vienīgi atbilstoši pacienti.
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.
Latvian: CHMP atzinumu nosūtīja Eiropas Komisijai, kas to apstiprināja un 2014. gada 15. aprīlī pieņēma galīgo juridiski saistošo lēmumu, kas ir spēkā visā Eiropas Savienībā.
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.'
Latvian: "Tomēr CHMP uzskatīja, ka pacientiem, kuriem nav pieejama alternatīva terapija, regulārs skrīnings un uzraudzība, lai izslēgtu kardiovaskulāru slimību, pietiekami mazinās PRAC konstatēto risku, lai šie pacientiem šīs zāles aizvien būtu pieejamas."
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.
Latvian: "Visu procedūras laiku PRAC cieši sadarbojās ar CHMP, un lai gan mēs atzīstam, ka abu komiteju ieteikumi ir atšķirīgi, mūsu izpratne par zāļu ieguvumu un riska attiecību ir ļoti līdzīga un mēs esam vienisprātis par kardiovaskulārā riska efektīvas uzraudzības nozīmi," teica PRAC vadītāja June Raine.
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;
Latvian: Kardiovaskulāras slimības risks pacientam jānovērtē pirms ārstēšanas uzsākšanas un regulāri turpmāk, parasti ik pēc 6-12 mēnešiem.
English: This final EMA recommendation on the use of Protelos/Osseor was based on an analysis of pooled data from randomised studies in around 7,500 post-menopausal women with osteoporosis.
Latvian: Šis EMA galīgais ieteikums par Protelos/Osseor lietošanu bija balstīts uz nejaušinātu pētījumu apvienoto datu analīzi aptuveni 7500 pēcmenopauzes vecuma sievietēm ar osteoporozi.
English: In addition, patients treated with Protelos/Osseor should be screened and monitored regularly, every 6 to 12 months.
Latvian: Turklāt ar Protelos/Osseor ārstētiem pacientiem regulāri (ik pēc 6-12 mēnešiem) jāveic skrīnings un uzraudzība.
English: The CHMP's recommendations were sent to the European Commission, which endorsed them and issued a final legally binding decision valid throughout the EU.
Latvian: CHMP ieteikumus nosūtīja Eiropas Komisijai, kas tos apstiprināja un pieņēma galīgo juridiski saistošo lēmumu, kas ir spēkā visā Eiropas Savienībā.
English: These final recommendations from the Agency's Committee for Medicinal Products for Human Use (CHMP) come after initial advice from the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend the medicine due to its cardiovascular risk.
Latvian: Šie Aģentūras Cilvēkiem paredzēto zāļu komitejas (CHMP) ieteikumi sniegti pēc Farmakovigilances riska vērtēšanas komitejas (PRAC) sākotnējā ieteikuma apturēt zāļu lietošanu kardiovaskulārā riska dēļ.
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.
Latvian: Abas komitejas cieši sadarbojās, un PRAC ieteikumu mēs izmantojām, lai pilnībā novērtētu šo zāļu ieguvumu un riska attiecību," sacīja CHMP vadītājs Tomas Salmonson.