natgillin/translations-raw huggingface dataset:
In patients receiving Erbitux in combination with oxaliplatin-containing chemotherapy (FOLFOX) patients with wild-type RAS lived for longer without their disease getting worse compared with patients on FOLFOX alone (12.0 months compared with 5.8 months, on average).
Kui oksaliplatiini sisaldavale keemiaravile (FOLFOX) lisati Erbituxi, kulus muteerumata RAS-geeniga patsientidel haiguse süvenemiseni rohkem aega kui ainult FOLFOX-ravi korral (keskmiselt 12,0 kuud võrreldes 5,8 kuuga).
For cancers of the head and neck, Erbitux was investigated in two main studies:
Erbituxi tõhusust pea- ja kaelapiikonna kasvajate ravis uuriti kahes põhiuuringus:
One of the studies also looked at the results separately in patients whose tumours carried wild-type forms of all RAS genes and patients with mutated forms of any RAS gene.
Ühes uuringus vaadeldi eraldi ka muteerumata ja muteerunud RAS-geenidega kasvajatega patsientide tulemusi.
What benefit has Erbitux shown during the studies?
Milles seisneb uuringute põhjal Erbituxi kasulikkus?
How is Erbitux used?
Kuidas Erbituxi kasutatakse?
What is Erbitux used for?
Milleks Erbituxi kasutatakse?
How has Erbitux been studied?
Kuidas Erbituxi uuriti?
How does Erbitux work?
Kuidas Erbitux toimib?
Erbitux is also used to treat ‘squamous cell' cancers of the head and neck.
Erbituxi kasutatakse ka pea ja kaela lamerakk-kartsinoomide raviks.
Most of the studies looked at the results separately in patients whose tumours had wildtype KRAS (one of the types of RAS genes) and patients whose tumours had mutated KRAS.
Enamikus uuringutes vaadeldi eraldi muteerumata ja muteerunud KRAS-geeniga (RAS-geeni alaliik) kasvajatega patsientide tulemusi.
In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
Lokaalselt kaugelearenenud (metastaasideta) vähi korral kasutatakse Erbituxi koos kiiritusraviga.
In locally advanced head and neck cancers, the patients lived for longer without their disease getting worse when Erbitux was added to radiotherapy (24.4 months compared with 14.9 months, on average).
Pea- ja kaelapiirkonna paikse vähi korral kulus haiguse süvenemiseni Erbituxi lisamisel kiiritusravile rohkem aega (keskmiselt 24,4 kuud võrreldes 14,9 kuuga).
• the first study involved 424 patients with locally advanced cancer, looking at the effects of adding Erbitux to radiotherapy;
• esimeses uuringus osales 424 lokaalselt kaugelearenenud vähiga patsienti.
In the studies of cancer of the colon or rectum, Erbitux was shown overall to increase the time patients lived without their cancer getting worse or how long they survived:
Käär- ja pärasoolevähi uuringutes osalenud patsientidel, kes said Erbituxi, kulus haiguse süvenemiseni rohkem aega või elasid nad üldiselt kauem järgmistel juhtudel.
Patients who had failed oxaliplatin treatment lived for an average of 4.0 months without their disease getting worse with Erbitux plus irinotecan, compared with 2.6 months in those receiving irinotecan alone.
Progresseerumiseta elulemus oli patsientidel, kelle ravi oksaliplatiiniga ei andnud tulemusi, Erbituxi ja irinotekaani kasutamisel 4 kuud ning ainult irinotekaani kasutamisel 2,6 kuud.
Erbitux is used to treat metastatic cancer of the colon or rectum (large intestine).
Erbituxi kasutatakse metastaatilise käär- või pärasoolevähi raviks.
The medicine can only be obtained with a prescription.
Erbitux on retseptiravim.
EGFR is involved in switching on genes called RAS that are involved in the growth of cells; by attaching to EGFR, cetuximab prevents this from happening in the tumour cells and helps stop them growing.
EGFR-ga seondudes takistab tsetuksimaab seda protsessi vähirakkudes, pärssides nende kasvu.
Erbitux is given in the following ways:
Seda tohib kasutada nii:
United Kingdom Teva Uk Limited
Teva Uk Limited
United Kingdom Norton Healthcare Ltd T/A Ivax
Norton Healthcare Ltd T/A Ivax
Genéricos Españoles Laboratorio, S.A.
G,E,S, Genéricos Españoles Laboratorio, S.A.
Gastro-Resistant Capsule
Gastroresistentne kapsel
United Kingdom Noridem Enterprises Ltd Sodium Valproate Noridem Enterprises
Noridem Enterprises Ltd Naatriumvalproaat Noridem Enterprises
Valproate Magnesium 10000mg/100 Ml
Magneesiumvalproaat 10000 mg/100 ml
United Kingdom Winthrop Pharmaceuticals Uk Ltd
Winthrop Pharmaceuticals Uk Ltd
Prolonged-Release Capsule
Toimeainet prolongeeritult vabastav kapsel
Sanofi-Aventis Cyprus Ltd
Sanofi-Aventis Kypros Ltd
Sodium Valproate Wockhardt Uk
Naatriumvalproaat Wockhardt Uk
ácido Valpróico Generis Valproic Acid 400mg/4 Ml
ácido Valpróico Generis Valproehape 400 mg/4 ml
Sodium Valproate Bp 200mg
Naatriumvalproaat Bp 200 mg
United Kingdom Aventis Pharma Ltd Epilim Chrono
Aventis Pharma Ltd Epilim Chrono
Depakine Chrono 500 Valproic Acid 145.14mg Tablet, Sodium
Depakine Chrono 500 Valproehape 145,14 mg tablett,
Solution For Injection Intravenous Use
Süste/infusioonilahus Intravenoosne
Valproate Semisodium 269.1mg Tablet
Seminaatriumvalproaat 269,1 mg tablett
Valproate Semisodium 538.2mg Tablet
Seminaatriumvalproaat 538,2 mg tablett
Natriumvalproat Aristo Sodium Valproate 300mg G
Natriumvalproat Aristo Naatriumvalproaat 300 mg G
Sodium Valproate Wockhardt
Naatriumvalproaat Wockhardt
Valproic Acid 43.38mg/Ml
Valproehape 43,38 mg/ml
Intravenous Use
Intravenoosne
ácido Valproico G.E.S Sodium Valproate 400mg Vial
ácido Valproico G.E.S Naatriumvalproaat 400 mg viaal
United Kingdom Aventis Pharma Ltd Depakote
Aventis Pharma Ltd Depakote
Valproic Acid 145mg G, Sodium Valproate 333mg G
Valproehape 145 mg G, Naatriumvalproaat 333 mg G
Valproic Acid 87mg G, Sodium Valproate 200mg Tablet
Valproehape 87 mg G, Naatriumvalproaat 200 mg tablett
Valproat Ratiopharm Valproic Acid 145mg G, Sodium Valproate
Valproat Ratiopharm Valproehape 145 mg G, Naatriumvalproaat
United Kingdom Aventis Pharma Ltd Epilim
Aventis Pharma Ltd Epilim
Natriumvalproaat Teva Valproic Acid 145mg G, Sodium Valproate
Natriumvalproaat Teva Valproehape 145 mg G, Naatriumvalproaat
Modified-Release Tablet Oral Use
Toimeainet modifitseeritult vabastav tablett
Depakine Chrono 300 Valproic Acid 87mg Tablet, Sodium
Depakine Chrono 300 Valproehape 87 mg tablett,
Prolonged-Release Granules
Toimeainet prolongeeritult vabastavad graanulid
Valproic Acid 50mg/Ml
Valproehape 50 mg/ml
Sodium Valproate 400mg Vial
Naatriumvalproaat 400 mg viaal
Sodium Valproate Winthrop
Naatriumvalproaat Winthrop
Sodium Valproate 1000mg Container
Naatriumvalproaat 1000 mg konteiner
Sodium Valproate Ivax Sodium Valproate 200mg/5 Ml
Naatriumvalproaat Ivax Naatriumvalproaat 200 mg/5 ml
Solution For Injection/Infusion
Süste/infusioonilahuse kontsentraat
ácido Valpróico Generis Valproic Acid 145mg Tablet, Sodium
ácido Valpróico Generis Valproehape 145 mg tablett,
ácido Valpróico Generis Valproic Acid 87mg Tablet, Sodium
ácido Valpróico Generis Valproehape 87 mg tablett,
Powder And Solvent For Solution For Injection/Infusion
Süste/infusioonilahuse pulber ja lahusti
Prolonged-Release Granules In Sachet
Toimeainet prolongeeritult vabastavad graanulid kotikeses
Sodium Valproate 500mg
Naatriumvalproaat 500 mg
Sodium Valproate 200mg
Naatriumvalproaat 200 mg
Sodium Valproate 500mg Container
Naatriumvalproaat 500 mg konteiner
Valproate Retard Mylan Sodium Valproate 500mg Tablet
Valproate Retard Mylan Naatriumvalproaat 500 mg tablett
Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Austria sanofi-aventis GmbH Depakine Chronosphere Valproehape 145,14 mg kotike,
Espa-Valept Retard Sodium Valproate 300mg Tablet
Espa-Valept Retard Naatriumvalproaat 300 mg tablett
Valproate Retard Mylan Sodium Valproate 300mg Tablet
Valproate Retard Mylan Naatriumvalproaat 300 mg tablett
Depakine Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Depakine Chronosphere Valproehape 217,75 mg kotike,
Sodium Valproate 400mg Container
Naatriumvalproaat 400 mg konteiner
Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Sanofi-Aventis Aebe Depakine Chronosphere Valproehape 29,03 mg kotike,
Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Austria sanofi-aventis GmbH Depakine Chronosphere Valproehape 72,61 mg kotike,
Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Sanofi-Aventis Aebe Depakine Chronosphere Valproehape 290,27 mg kotike,
Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Sanofi-Aventis Aebe Depakine Chronosphere Valproehape 72,61 mg kotike,
Valproat Neuraxpharm Sodium Valproate 60mg/Ml
Valproat Neuraxpharm Naatriumvalproaat 60 mg/ml
Valproate Magnesium 500mg Tablet
Magneesiumvalproaat 500 mg tablett
Sodium Valproate 300mg Capsule
Naatriumvalproaat 300 mg kapsel
Sodium Valproate 150mg Capsule
Naatriumvalproaat 150 mg kapsel
Valproate Semisodium 250mg Tablet
Seminaatriumvalproaat 250 mg tablett
Valproate 333mg Tablet
333,3 mg tablett
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproehape 72,61 mg kotike,
Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Depakine Chronosphere Valproehape 290,27 mg kotike,
Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Austria sanofi-aventis GmbH Depakine Chronosphere Valproehape 14,51 mg kotike,
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproehape 29,03 mg kotike,
Sodium Valproate 300mg
Naatriumvalproaat 300 mg
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproehape 217,75 mg kotike,
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproehape 145,14 mg kotike,
Valproate Magnesium 200mg Tablet
Magneesiumvalproaat 200 mg tablett
Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Epilim Chronosphere Valproehape 29,03 mg kotike,
Sodium Valproate 500mg Capsule
Naatriumvalproaat 500 mg kapsel
Modified-Release Capsule, Hard
Toimeainet modifitseeritult vabastav kõvakapsel
Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Epilim Chronosphere Valproehape 72,61 mg kotike,
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproehape 290,27 mg kotike,
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproehape 14,51 mg kotike,
Valproat Neuraxpharm Sodium Valproate 300mg/Ml
Valproat Neuraxpharm Naatriumvalproaat 300 mg/ml
ácido Valpróico Sandoz Sodium Valproate 500mg Tablet
ácido Valpróico Sandoz Naatriumvalproaat 500 mg tablett
ácido Valpróico Sandoz Sodium Valproate 300mg Tablet
ácido Valpróico Sandoz Naatriumvalproaat 300 mg tablett
Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Depakine Chronosphere Valproehape 29,03 mg kotike,
Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Depakine Chronosphere Valproehape 14,51 mg kotike,
Valproate 200mg Tablet
Valpromiid 300 mg tablett
Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Depakine Chronosphere Valproehape 145,14 mg kotike,
Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Depakine Chronosphere Valproehape 72,61 mg kotike,
Acido Valproico Sandoz Sodium Valproate 500mg Tablet
Acido Valproico Sandoz Naatriumvalproaat 500 mg tablett
Acido Valproico Sandoz Sodium Valproate 300mg Tablet
Acido Valproico Sandoz Naatriumvalproaat 300 mg tablett
Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Epilim Chronosphere Valproehape 145,14 mg kotike,
Valproate Retard Eg Valproic Acid 87mg Tablet, Sodium
Valproate Retard Eg Valproehape 87 mg tablett,
Sodium Valproate 1000mg Sachet
Naatriumvalproaat 1000 mg kotike
Valproát Chrono Sandoz Sodium Valproate 500mg Tablet
Valproát Chrono Sandoz Naatriumvalproaat 500 mg tablett
Valproat Chrono Sandoz Sodium Valproate 500mg Tablet
Valproat Chrono Sandoz Naatriumvalproaat 500 mg tablett
Valproat 1 A Pharma Sodium Valproate 150mg Tablet
Valproat 1 A Pharma Naatriumvalproaat 150 mg tablett
Valproat Neuraxpharm Sodium Valproate 600mg Units
Valproat Neuraxpharm Naatriumvalproaat 600 mg ühikut
Valproat Chrono Sandoz Sodium Valproate 300mg Tablet
Valproat Chrono Sandoz Naatriumvalproaat 300 mg tablett
Valproát Chrono Sandoz Sodium Valproate 300mg Tablet
Valproát Chrono Sandoz Naatriumvalproaat 300 mg tablett
Valproat Neuraxpharm Sodium Valproate 150mg Units
Valproat Neuraxpharm Naatriumvalproaat 150 mg ühikut
Valproic Acid 72.61mg Sachet, Sodium Valproate 166.76mg Sachet
Naatriumvalproaat 166,76 mg kotike
Valproat 1 A Pharma Sodium Valproate 300mg Tablet
Valproat 1 A Pharma Naatriumvalproaat 300 mg tablett
Valproat 1 A Pharma Sodium Valproate 500mg Tablet
Valproat 1 A Pharma Naatriumvalproaat 500 mg tablett
Valproate Retard Eg Valproic Acid 145mg Tablet, Sodium
Valproate Retard Eg Valproehape 145 mg tablett,
Valproat 1 A Pharma Sodium Valproate 600mg Tablet
Valproat 1 A Pharma Naatriumvalproaat 600 mg tablett
Valproic Acid 29.03mg Sachet, Sodium Valproate 66.66mg Sachet
Naatriumvalproaat 66,66 mg kotike
Valproic Acid 290.27mg Sachet, Sodium Valproate 666.6mg Sachet
Naatriumvalproaat 666,6 mg kotike
Valproat Neuraxpharm Sodium Valproate 500mg Units
Valproat Neuraxpharm Naatriumvalproaat 500 mg ühikut
Valproat Neuraxpharm Sodium Valproate 300mg Units
Valproat Neuraxpharm Naatriumvalproaat 300 mg ühikut
Sodium Valproate Teva Sodium Valproate 200mg Tablet
Naatriumvalproaat Teva Naatriumvalproaat 200 mg tablett
Valpromide 300mg Tablet
Seminaatriumvalproaat 500 mg tablett
Sodium Valproate 300mg Suppository
Naatriumvalproaat 300 mg rektaalsuposiit
Oral Drops, Solution Oral Use
Suukaudsed tilgad, lahus
What measures are being taken to ensure the safe and effective use of Ucedane?
Mis meetmed võetakse, et tagada Ucedane ohutu ja efektiivne kasutamine?
Treatment may be started as early as the first day of life and the medicine is used for the patient's whole life.
Ravi võib alustada esimesel elupäeval ja ravimit kasutatakse kogu elu.
The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Ucedane algannus on 100 mg kehakaalu kg kohta ööpäevas, kuid vajaduse korral tohib kasutada kuni 250 mg/kg.
The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst Ucedane kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Ucedane and what is it used for?
Mis on Ucedane ja milleks seda kasutatakse?
Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water.
Ucedanet turustatakse dispergeeruvate tablettidena (200 mg), mis dispergeeritakse (segatakse) väikeses koguses vees.
As for every medicine, the company provided studies on the quality of Ucedane.
Nagu iga ravimi korral, esitas ettevõte uuringud Ucedane kvaliteedi kohta.
Ucedane carglumic acid
Ucedane kargluumhape
The Committee recommended that Ucedane be approved for use in the EU.
Komitee soovitas Ucedane kasutamise Euroopa Liidus heaks kiita.
Why is Ucedane approved?
Miks Ucedane heaks kiideti?
The dose should then be adjusted to maintain normal blood ammonia levels.
Annust võib seejärel kohandada, et säilitada vere normaalne ammoniaagisisaldus.
It is not intended to provide practical advice on how to use Ucedane.
Hindamisaruandes ei anta Ucedane kasutamise praktilisi nõuandeid.
Ucedane therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects.
Seega aitab Ucedane lagundada ammoniaaki ja vähendab ammoniaagi sisaldust veres ning selle mürgist toimet.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ucedane has been shown to have comparable quality and to be bioequivalent to Carbaglu.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Ucedane võrreldav kvaliteet ja bioekvivalentsus ravimiga Carbaglu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ucedane have been included in the summary of product characteristics and the package leaflet.
Ucedane ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia.
Selle eluaegse haigusega patsientidel puudub maksaensüüm N-atsetüülglutamaadi süntaas, mis aitab tavaliselt ammoniaaki lagundada.
Because Ucedane is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Et Ucedane on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
Other information about Ucedane
Muu teave Ucedane kohta
This means that Ucedane contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Carbaglu.
See tähendab, et Ucedane sisaldab sama toimeainet ja toimib samal viisil kui võrdlusravim Carbaglu, millel juba on Euroopa Liidus müügiluba.
If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.
Kui see ensüüm puudub, siis ammoniaak ei lagune ja koguneb verre.
Therefore, the CHMP's view was that, as for Carbaglu, the benefit outweighs the identified risk.
Seetõttu on inimravimite komitee arvamusel, et nagu ka Carbaglu korral, ületab ravimi Ucedane kasulikkus sellega kaasnevad riskid.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Carbaglu, and do not need to be repeated for Ucedane.
Võrdlusravimiga Carbaglu on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Ucedane korrata.
For practical information about using Ucedane, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate Ucedane kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
This is a summary of the European public assessment report (EPAR) for Ucedane.
See on ravimi Ucedane Euroopa avaliku hindamisaruande kokkuvõte.
How is Ucedane used?
Kuidas Ucedanet kasutatakse?
Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with N-acetylglutamate synthase (NAGS) deficiency.
Ucedane on ravim, mida kasutatakse hüperammoneemia (vere suur ammoniaagisisaldus) raviks N-atsetüülglutamaadi süntaasi (NAGS) vaegusega patsientidel.
For more information about treatment with Ucedane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Ucedanega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
The active substance in Ucedane, carglumic acid, is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia.
Ucedane toimeaine kargluumhape on struktuurilt väga sarnane N-atsetüülglutamaadiga, mis aktiveerib ammoniaaki lagundavat ensüümi.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with metabolic diseases such as NAGS deficiency.
Ucedane on retseptiravim ja ravi tohib alustada üksnes ainevahetushaigustega (nagu NAGS-i vaegus) patsientide ravis kogenud arst.
What are the benefits and risks of Ucedane?
Milles seisneb Ucedane kasulikkus ja mis riskid ravimiga kaasnevad?
When ammonia builds up in the blood, it is toxic to the body, especially the brain.
Verre kogunenud ammoniaak on organismile, eriti ajule mürgine.
Ucedane contains the active substance carglumic acid and is a ‘generic medicine'.
Ucedane sisaldab toimeainena kargluumhapet ja see on geneeriline ravim.
How does Ucedane work?
Kuidas Ucedane toimib?
How has Ucedane been studied?
Kuidas Ucedanet uuriti?
EU/1/04/273/001 Lysodren
EU/1/04/273/001
Invented name Strength Pharmaceutical form Route of administration Packaging
Müügiloa nr Euroopa Liidus Ravimpreparaadi nimetus Tugevus Ravimvorm Manustamisviis Pakend
500 mg
500 mg Tablett
Date of first authorisation: 09 November 2015
Esmase müügiloa väljastamise kuupäev: 9. november 2015
Additional risk minimisation measures
Täiendavad riski minimeerimise meetmed
These effects were sustained in longer-term studies.
Need toimed püsisid pikemaajalistes uuringutes.
More information is given below under ‘Other medicines and Edistride'.
Rohkem teavet on esitatud allpool lõigus ‘Muud ravimid ja Edistride';
The patient may need to take extra insulin and drink water.
Patsient võib vajada lisakogust insuliini ja juua vett.
Edistride is used in adult patients (aged 18 years and older).
Edistridet kasutatakse täiskasvanud patsientidel (18-aastased ja vanemad).
Edistride is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Edistridet ei soovitata lastele ega alla 18-aastastele noorukitele, kuna seda ravimit ei ole neil patsientidel uuritud.
Measure your ketone levels again in 2 hours.
Mõõtke oma ketokehade sisaldust uuesti 2 tunni pärast.
The recommended actions are listed in Table 1.
Soovitatavad meetmed on loetletud tabelis 1.
See “Description of selected adverse reactions” and section 4.4.
Vt lõiku „Valitud kõrvaltoimete kirjeldus“ ja lõiku 4.4.
Edistride can be taken orally once daily at any time of day with or without food.
Edistridet võib võtta suukaudselt üks kord ööpäevas suvalisel ajal kas toiduga või ilma.
• For renal function with GFR < 60 mL/min, at least 2 to 4 times per year.
• neerufunktsioon, mille puhul GFR on < 60 ml/min, vähemalt kaks kuni neli korda aastas.
Patients should consider monitoring ketones levels three to four hours after changing pump materials.
Patsiendid peavad kaaluma ketokehade sisalduse kontrollimist kolme kuni nelja tunni möödumisel pumba materjalide vahetamisest.
Obligation to conduct post-authorisation measures: The MAH shall complete, within the stated timeframe, the below measures: Description
Kohustus võtta loa andmise järgseid meetmeid: Müügiloa hoidja võtab kehtestatud ajavahemiku jooksul järgmised meetmed: Kirjeldus
If you have type 2 diabetes, it can also help prevent heart disease.
Kui teil on 2. tüüpi suhkurtõbi, võib see samuti aidata ennetada südamehaigust.
This may occur regardless of blood sugar level.
See võib tekkida sõltumata veresuhkru sisaldusest.
Diet and exercise can help your body use its blood sugar better.
Dieet ja füüsiline koormus võivad aidata teie kehal veresuhkrut paremini kasutada.
• Edistride is used together with insulin.
• Edistridet kasutatakse koos insuliiniga.
Your doctor may decide to temporarily or permanently stop your treatment with Edistride.
Teie arst võib otsustada ajutiselt või täielikult lõpetada ravi Edistridega.
The recommended actions are listed in Table 1 (see section 4.2).
Soovitatavad meetmed on loetletud tabelis 1 (vt lõik 4.2).
• If it is 12 hours or more until your next dose, take a dose of Edistride as soon as you remember.
• Kui teie järgmise annuseni on jäänud 12 või rohkem tundi, siis võtke Edistride annus niipea, kui see teile meenub.
• Summary of the recommendations for patients, particularly regarding blood ketone measurement and managing sick days.
• Patsientidele mõeldud soovituste kokkuvõte, mis puudutab eelkõige ketokehade sisalduse mõõtmist verest ja haiguspäevadega toimetulemist.
Ketone levels should be also checked in situations that may predispose to or increase risk of DKA.
Ketokehade sisaldust tuleb kontrollida ka olukordades, mis võivad DKA teket soodustada või selle tekkeriski suurendada.
glimepiride 4 mg/day;
Glimepiriid 4 mg/ööpäevas;
See corresponding subsection below for additional information.
Lisateabeks vt vastavat alalõiku allpool.