FrancophonIA/ELRC3.0 huggingface dataset:
English: The Summary of Product Characteristics for all medicinal products used in combination with Empliciti must be consulted before starting therapy.
Estonian: Enne ravi alustamist tuleb tutvuda Emplicitiga koosmanustatavate kõikide ravimi omaduste kokkuvõtetega.
English: Powder for concentrate for solution for infusion 1 vial
Estonian: RAVIMVORM JA PAKENDI SUURUS Infusioonilahuse kontsentraadi pulber 1 viaal
English: Exposure-adjusted rates for adverse reactions (all Grades and Grade 3/4) in CA204004, a clinical trial in patients with multiple myeloma comparing Empliciti combined with lenalidomide and dexamethasone treatment (N = 318) to lenalidomide and dexamethasone treatment (N = 317), is shown in Table 6.
Estonian: Ravimi ekspositsiooni suhtes kohandatud kõrvaltoimete esinemissageduse määrad (kõik raskusastmed ning 3. ja 4. raskusaste) uuringus CA204004, mis oli kliiniline uuring hulgimüeloomiga patsientidel, milles Empliciti kombinatsioonravi lenalidomiidi ja deksametasooniga (N = 318) võrreldi lenalidomiidi ja deksametasooniga (N = 317), on esitatud tabelis 6.
English: Median PFS (months) [95% CI]
Estonian: PFS-i mediaan kuudes [95% CI]
English: E-Ld 321 282 240 206 164 133 87 43 12 1
Estonian: Riskirühma kuuluvate uuringus osalejate arv E-Ld 321 282 240 206 164 133 87 43 12 1 Ld 325 262 204 168 130 97 53 24 7
English: Infusion related reaction
Estonian: Infusiooniga seotud reaktsioonid
English: After reconstitution and dilution The reconstituted solution should be transferred from the vial into the infusion bag immediately.
Estonian: Valmistamise ja lahjendamise järgselt Valmis manustamiskõlblik lahus tuleb kohe kanda viaalist infusioonikotti.
English: Infusion related reaction Common
Estonian: Infusiooni ga seotud reaktsioon
English: You must use effective contraception while you are being treated with Empliciti, if there is any chance you could become pregnant.
Estonian: Kui te olete rasestumisvõimeline naine, peate te ravi ajal Emplicitiga kasutama tõhusat rasestumisvastast vahendit.
English: Grade 3-4 infections were noted in 13.3% and 21.8% of Empliciti combined with pomalidomide and dexamethasone and pomalidomide and dexamethasone treated patients, respectively.
Estonian: 3. kuni 4. raskusastme infektsioone täheldati 13,3%-l Emplicitit kombinatsioonis pomalidomiidi ja deksametasooniga saanud ning 21,8%-l pomalidomiidi ja deksametasooniga ravitud patsientidest.
English: Mood altered 1
Estonian: Meeleolu muutused a
English: EU/1/16/1088/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/16/1088/001
English: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Estonian: Bristol-Myers Squibb S.A. Tél/Tel: + 32 2 352 76 11
English: Grade 3-4 infections were noted in 28% and 24.3% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
Estonian: 3. kuni 4. astme infektsioone märgiti 28%-l ja 24,3%-l patsientidest, kes said vastavalt Emplicitit koos lenalidomiidi ja deksametasooniga ning lenalidomiidi ja deksametasooni.
English: HR [95% CI]
Estonian: Riskimäär [95% CI]
English: Frequency overall
Estonian: Sagedus
English: The flip-off seal button colour is ivory for the 300 mg presentation and blue for the 400 mg presentation.
Estonian: 300 mg sisaldava pakendi eemaldatav kate on elevandiluu värvi ja 400 mg pakendil sinist värvi.
English: The administration of the reconstituted and diluted solution must be initiated at an infusion rate of 0.5 mL/min.
Estonian: Manustamiskõlblikuks muudetud ja lahjendatud vedeliku manustamist tuleb alustada infusioonikiirusega 0,5 ml/minutis.
English: There is no human experience with elotuzumab during pregnancy.
Estonian: Elotuzumabi kasutamise kohta rasedatel andmed puuduvad.
English: In a clinical trial of patients with multiple myeloma that compared Empliciti combined with lenalidomide and dexamethasone treatment to lenalidomide and dexamethasone treatment (CA204004), the incidence of SPMs, and specifically of solid tumours and non-melanoma skin cancer, was higher in patient treated with Empliciti (see section 4.8).
Estonian: Sekundaarsed esmased halvaloomulised kasvajad (second primary malignancies, SPM-id) Hulgimüeloomiga patsientidega läbi viidud kliinilises uuringus, kus Empliciti kombinatsioonravi lenalidomiidi ja deksametasooniga võrreldi lenalidomiid- ja deksametasoonraviga (CA204004), oli SPM ide ning eriti soliidtuumorite ja mittemelanoomse nahavähi esinemissagedus Emplicitit saanud patsientide rühmas suurem (vt lõik 4.8).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PAKEND
English: Second Primary Malignancies are known to be associated with lenalidomide exposure which was extended in patients treated with Empliciti combined with lenalidomide and dexamethasone vs. lenalidomide and dexamethasone.
Estonian: Sekundaarsed esmased halvaloomulised kasvajad on teadaolevalt seotud lenalidomiidiga, mille kasutamine pikenes kombinatsioonis Empliciti koos lenalidomiidi ja deksametasooniga vs. lenalidomiid ja deksametasoon.
English: If you miss a dose of Empliciti
Estonian: Kui te unustate Emplicitit kasutada
English: b The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.
Estonian: Mõiste pneumoonia alla kuuluvad kopsupõletik, atüüpiline kopsupõletik, bronhopneumoonia, lobaarpneumoonia, bakteriaalne kopsupõletik, mükootiline pneumoonia, viiruspneumoonia ja pneumokokk-pneumoonia.
English: Calculate the dose (mg) and determine the number of vials needed for the dose (10 mg/kg or 20 mg/kg) based on patient weight.
Estonian: Patsiendi kehakaalu alusel arvutatakse annus (mg) ja määratakse annuseks (10 mg/kg või 20 mg/kg) vajaminevate viaalide arv.
English: d The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, herpes virus infection and ophthalmic herpes zoster.
Estonian: d Mõiste herpes zoster alla kuuluvad vöötohatis, huuleherpes, herpesviirusnakkus ja silma herpes zoster.
English: PHARMACEUTICAL FORM AND CONTENTS
Estonian: Muud ravimid ja Empliciti
English: What Empliciti is and what it is used for 2.
Estonian: 1. Mis ravim on Empliciti ja milleks seda kasutatakse 2. Mida on vaja teada enne Empliciti kasutamist 3.
English: The administration of reconstituted and diluted solution must be initiated at an infusion rate of 3 mL/min.
Estonian: Manustamiskõlblikuks muudetud ja lahjendatud lahuse manustamist tuleb alustada infusioonikiirusega 3 ml/minutis.
English: Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5-20 mg/kg.
Estonian: Elotuzumabi farmakokineetika on mittelineaarne, kliirens väheneb annuse suurenemisel vahemikus 0,5...20 mg/kg.
English: Non-melanoma skin cancer was reported in 3.1% and 1.6% of patients treated with Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone, respectively.
Estonian: Mittemelanoomset nahavähki registreeriti 3,1%-l ja 1,6%-l patsientidest, kes said vastavalt Emplicitit koos lenalidomiidi ja deksametasooniga ning lenalidomiidi ja deksametasooni.
English: In a clinical trial of patients with multiple myeloma (CA204004), infections were reported in 81.4% of patients in the Empliciti combined with lenalidomide and dexamethasone arm (N = 318) and 74.4% in lenalidomide and dexamethasone arm (N = 317).
Estonian: Hulgimüeloomiga patsientide kliinilises uuringus (CA204004) registreeriti infektsioone 81,4%-l patsientidest, kes said Emplicitit kombinatsioonis lenalidomiidi ja deksametasooniga (N = 318), ning 74,4%-l lenalidomiidi ja deksametasooni rühmas (N = 317).
English: Preparation of the solution for infusion
Estonian: Infusioonilahuse ettevalmistamine
English: Very Good Partial Response (VGPR) n (%) Partial Response (RR/PR) n (%) Combined Responses (CR+sCR+VGPR) n (%) Overall Survivalg Hazard Ratio [95.4% CI] Stratified log-rank test p-value
Estonian: Väga hea osaline ravivastus (VGPR) n (%) Osaline ravivastus (RR/PR) n (%) Kombineeritud ravivastus (CR + sCR + VGPR) n (%) Üldine elulemusg
English: Vascular disorders
Estonian: Vaskulaarsed häired Süvaveenitromboos
English: PFS (ITT) Hazard Ratio [95% CI] Stratified log-rank test p-valuea Median PFS in months [95% CI]
Estonian: Riskimäär [95,4% CI] Stratifitseeritud logaritmilise astaktesti p-väärtus
English: Empliciti has not been studied in patients with moderate (TB > 1.5 to 3 × ULN and any AST) or severe (TB > 3 × ULN and any AST) hepatic impairment (see section 5.2).
Estonian: Mõõduka (BIL > 1,5...3 × ULN ja mis tahes ASAT) või raske (BIL > 3 × ULN ja mis tahes ASAT) maksakahjustusega patsientidel ei ole Emplicitit kasutamist uuritud (vt lõik 5.2).
English: Solid tumours were reported in 2.5% and 1.9% of Empliciti combined with lenalidomide and dexamethasone and lenalidomide and dexamethasone treated patients, respectively.
Estonian: Soliidtuumorite esinemist registreeriti 2,5%-l ja 1,9%-l patsientidest, kes said vastavalt Emplicitit koos lenalidomiidi ja deksametasooniga ning lenalidomiidi ja deksametasooni.
English: Pneumoniab
Estonian: Kopsupõletikb
English: Infusion rate for Empliciti 20 mg/kg
Estonian: Empliciti 20 mg/kg infusioonikiirus
English: Infusion rate for Empliciti 10 mg/kg
Estonian: Empliciti 10 mg/kg infusioonikiirus
English: Oropharyngeal pain
Estonian: Kehakaalu langus
English: Common
Estonian: Standardrisk
English: There were no SPM events reported in patients treated in the Empliciti combined with pomalidomide and dexamethasone study arm (N = 60) and 1 (1.8%) in patients treated in the pomalidomide and dexamethasone arm (N = 55) in study CA204125.
Estonian: Uuringus CA204125 Emplicitit kombinatsioonis pomalidomiidi ja deksametasooniga saanud patsientidel (N = 60) sekundaarseid esmaseid pahaloomulisi kasvajaid ei kirjeldatud ning pomalidomiidi ja deksametasooniga ravitud patsientide rühmas (N = 55) täheldati 1 juhtu (1,8%).
English: Weight decreased
Estonian: raskusaste Kõrvaltoime Juhtu de arv
English: Each vial contains 400 mg elotuzumab.
Estonian: Üks viaal sisaldab 400 mg elotuzumabi.
English: In the clinical trial of patients with multiple myeloma (CA204004), invasive SPMs have been observed in 6.9% of patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 4.1% of patients treated with lenalidomide and dexamethasone (N = 317).
Estonian: Hulgimüeloomiga patsiente hõlmanud kliinilises uuringus (CA204004) esines invasiivset SPM-i Emplicitit kombinatsioonis lenalidomiidi ja deksametasooniga saavas rühmas 6,9%-l patsientidest (N = 318) ning lenalidomiidi ja deksametasooni saavas rühmas 4,1%-l (N = 317) patsientidest.
English: d The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, and herpes virus infection.
Estonian: d Mõiste Herpes Zosteri alla kuuluvad vöötohatis, huuleherpes ja herpesviirusnakkused.
English: In a clinical trial of patients with multiple myeloma (CA204004), deep vein thromboses were reported in 7.2% of patients treated with Empliciti combined with lenalidomide and dexamethasone (N = 318) and 3.8% of patients treated with lenalidomide and dexamethasone (N = 317).
Estonian: Hulgimüeloomiga patsiente hõlmanud kliinilises uuringus (CA204004) esines süvaveenitromboosi 7,2%-l patsientidest Emplicitit kombinatsioonis lenalidomiidi ja deksametasooniga saavas rühmas -(N = 318) ning 3,8%-l lenalidomiidi ja deksametasooni saavas rühmas -(N = 317) patsientidest.
English: Table 4: Infusion rate for Empliciti 20 mg/kg
Estonian: Tabel 4: Empliciti 20 mg/kg infusioonikiirus
English: On weeks with Empliciti infusion, dexamethasone was administered before Empliciti as a divided dose: subjects  75 years an oral dose of 28 mg and an intravenous dose of 8 mg, and in subjects > 75 years an oral dose of 8 mg and an intravenous dose of 8 mg. On weeks without an Empliciti infusion and in the control group, dexamethasone was administered in subjects  75 years as an oral dose of 40 mg and in subjects > 75 years as an oral dose of 20 mg dexamethasone.
Estonian: Empliciti infusiooni nädalatel manustati deksametasooni enne Emplicitit jagatud annustena: ≤ 75-aastastele patsientidele 28 mg suukaudne ja 8 mg intravenoosne annus ning > 75-aastastele 8 mg suukaudne ja 8 mg intravenoosne annus.
English: Day of Cycle 1 Premedication
Estonian: 1. ravikuur, 1. annus
English: Each vial contains 300 mg elotuzumab.
Estonian: Üks viaal sisaldab 300 mg elotuzumabi.
English: Median OS in months [95% CI]
Estonian: OS-i mediaan kuudes [95% CI]
English: Elotuzumab has not been studied in patients with moderate (TB > 1.5 to 3 × ULN and any AST) or severe hepatic impairment (TB > 3 × ULN and any AST) (see section 4.2).
Estonian: Mõõduka (BIL > 1,5...3 × ULN ja mis tahes ASAT) või raske (BIL > 3 × ULN ja mis tahes ASAT) maksakahjustusega patsientidel ei ole Emplicitit uuritud (vt lõik 4.2).
English: Bristol-Myers Squibb SARL Tél: + 33 (0)1 58 83 84 96
Estonian: Bristol-Myers Squibb SARL Tel: + 33 1 58 83 84
English: Table 2: Infusion rate for Empliciti 10 mg/kg
Estonian: Tabel 2: Empliciti 10 mg/kg infusioonikiirus
English: The rates of deep vein thromboses observed between treatment arms were similar for patients given prophylaxis with low molecular weight heparin (2.2% in both treatment arms), and for patients given vitamin K antagonists the rates were 0% for patients treated with E-Ld and 6.7% for patients treated with Ld.
Estonian: Patsientidel, kellele manustati K vitamiini antagonisti olid esinemissagedused vastavalt 0% E-Ld ravirühmas ning 6,7% Ld ravirühmas.
English: Psychiatric disorders
Estonian: Psühhiaatrilised häired Meeleolu muutused
English: Gently mix the infusion by manual rotation.
Estonian: Segamiseks pöörake infusioonikotti käes.
English: Cycle 1, Dose 2
Estonian: 1. ravikuur, 2. annus
English: Table 3: Infusion rate for Empliciti 10 mg/kg
Estonian: Tabel 3: Empliciti 10 mg/kg infusioonikiirus
English: Your doctor may decide not to continue Empliciti treatment if you have a strong infusion reaction.
Estonian: Kui teil esineb raske infusioonireaktsioon, siis võib teie arst otsustada ravi Emplicitiga katkestada.
English: b The term lymphopenia includes the following terms: lymphopenia and lymphocyte count decreased.
Estonian: b Mõiste lümfopeenia alla kuuluvad lümfopeenia ja lümfotsüütide madal arv.
English: Table 3: Infusion rate for Empliciti 20 mg/kg
Estonian: Tabel 3: Empliciti 20 mg/kg infusioonikiirus
English: After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag immediately.
Estonian: Pärast manustamiskõlblikuks muutmist tuleb lahus kohe viaalist infusioonikotti üle kanda.
English: a The term cough includes the following terms: cough, productive cough, and upper airway cough syndrome.
Estonian: Mõiste köha alla kuuluvad köha, rögaeritusega köha ja ülemiste hingamisteede köha sündroom.
English: Overall Response (ORR)c n (%)
Estonian: c n (%)
English: Empliciti 300 mg powder for concentrate for solution for infusion.
Estonian: Empliciti 300 mg infusioonilahuse kontsentraadi pulber.
English: Empliciti 300 mg powder for concentrate for solution for infusion Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab
Estonian: Empliciti 300 mg infusioonilahuse kontsentraadi pulber Empliciti 400 mg infusioonilahuse kontsentraadi pulber elotuzumab
English: d The term cough includes the following terms: cough, productive cough, and upper airway cough syndrome.
Estonian: d Mõiste köha alla kuuluvad köha, rögaeritusega köha ja ülemiste hingamisteede köha sündroom.
English: Do not freeze the reconstituted or diluted solution.
Estonian: Manustamiskõlblikuks muudetud lahust ei tohi lasta külmuda.
English: If the infusion is well tolerated the infusion rate may be increased in a stepwise fashion as described in Table 3.
Estonian: Kui infusiooni talutakse hästi, siis võib infusioonikiirust järk-järgult suurendada, nagu on kirjeldatud tabelis 3.
English: Uncommon a The term herpes zoster is a grouping of the following terms: herpes zoster, oral herpes, and herpes virus infection.
Estonian: Mõiste Herpes Zosteri alla kuuluvad vöötohatis, huuleherpes ja herpesviirusnakkused.
English: c The term lymphopenia includes the following terms: lymphopenia and lymphocyte count decreased.
Estonian: c Mõiste lümfopeenia alla kuuluvad lümfopeenia ja lümfotsüütide madal arv.
English: If the infusion is well tolerated, the infusion rate maybe increased in a stepwise fashion as described in Table 4.
Estonian: Kui infusiooni talutakse hästi, siis võib infusioonikiirust järk-järgult suurendada, nagu on kirjeldatud tabelis 4.
English: Empliciti 400 mg powder for concentrate for solution for infusion.
Estonian: Empliciti 400 mg infusioonilahuse kontsentraadi pulber.
English: Empliciti 300 mg powder for concentrate elotuzumab
Estonian: RAVIMPREPARAADI NIMETUS Empliciti 300 mg kontsentraadi pulber elotuzumab
English: Empliciti 400 mg powder for concentrate elotuzumab
Estonian: RAVIMPREPARAADI NIMETUS Empliciti 400 mg kontsentraadi pulber elotuzumab
English: Pneumoniac
Estonian: Pneumoon iac
English: If well tolerated, the infusion rate maybe increased in a stepwise fashion as described in Table 3.
Estonian: Kui see on hästi talutav, siis võib infusioonikiirust järk-järgult suurendada, nagu on kirjeldatud tabelis 3.
English: Hepatic impairment
Estonian: Rindkere valu
English: Elotuzumab is not expected to be excreted into human milk.
Estonian: Eeldatavalt ei eritu elotuzumab rinnapiima.
English: If well tolerated, the infusion rate may be increased stepwise as described in Table 2.
Estonian: Kui infusiooni talutakse hästi, siis võib infusioonikiirust järk-järgult suurendada, nagu on kirjeldatud tabelis 2.
English: Final volume of reconstituted Empliciti in the vial
Estonian: Süstevee kogus, mis on vajalik valmistamiseks manustamiskõlblikuks muudetud Empliciti lõplik maht viaalis manustamiskõlblikuks muutmise järgne kontsentratsioon
English: There is no relevant use of Empliciti in the paediatric population for the indication of multiple myeloma.
Estonian: Lapsed Empliciti asjakohane kasutus lastel hulgimüeloomi näidustusel puudub.
English: Sodium citrate Citric acid monohydrate Polysorbate 80
Estonian: Naatriumtsitraat Sidrunhappe monohüdraat
English: See leaflet for further information.
Estonian: Lisateabe saamiseks tutvuge pakendi infolehega.
English: Dexamethasone (mg) intravenously Dexamethasone (mg) orally  75 years old 28 28 28 28 28 40 40 40 Dexamethasone (mg) orally > 75 years old 8 8 8 8 8 20 20 20 Day of Cycle 1 8 15 22 1 8 15 22
Estonian: Deksametasoon (mg), suukaudselt Ravikuuri päev 1 8 15 22 1 8 15 22
English: Hypoaesthesia 1
Estonian: Eelnevaid ravikuure=1
English: Cougha
Estonian: Kurguvalu
English: How Empliciti is given
Estonian: Kuidas Emplicitit manustatakse
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VIAALI ETIKETT
English: Table 1: Recommended dosing schedule of Empliciti in combination with lenalidomide and dexamethasone
Estonian: Empliciti, lenalidomiidi ja deksametasooni koosmanustamise soovitatav annustamisskeem
English: ANNEX II
Estonian: 1. annus
English: Very severe infusion reactions (≥ Grade 3) may require permanent discontinuation of Empliciti therapy and emergency treatment.
Estonian: Väga raskete infusioonireaktsioonide (≥ 3 .
English: Fatigue
Estonian: Kiirus
English: Empliciti 400 mg powder for concentrate for solution for infusion elotuzumab
Estonian: RAVIMPREPARAADI NIMETUS Empliciti 400 mg infusioonilahuse kontsentraadi pulber elotuzumab
English: For men taking Empliciti
Estonian: Mehed, kes saavad Empliciti ravi
English: Serious cases have also been received following the implementation of the related risk minimisation measures.
Estonian: Rasketest juhtumitest on teatatud ka pärast asjaomaste riskivähendusmeetmete võtmist.
English: Flupirtine is a ‘selective neuronal potassium channel opener' that acts by opening Kv7 potassium channels leading to functional N-methyl-D-aspartate receptor antagonism.
Estonian: Flupirtiin avab selektiivselt närvrakumembraani kaaliumikanaleid (SNEPCO), avades valgu Kv7 kaaliumikanalid, tekitades N-metüül-D-aspartaadi (NMDA) retseptorite funktsionaalse antagonismi.
English: This included additional materials to communicate on the previous measures, reduction of the pack size, and introduction of a new warning regarding genetic risk factors.
Estonian: Need on näiteks täiendavad teabematerjalid varasemate meetmete kohta, väiksem pakendisuurus ja uue hoiatuse lisamine geneetiliste riskitegurite kohta.
English: It was noted that no medical guidelines recommending the use of flupirtine in any pain indication could be identified.
Estonian: Samuti märgiti, et ei leitud ravisuuniseid, kus oleks soovitatud flupirtiini kasutamist mis tahes valu vaigistamise näidustusel.
English: On 19 October 2017, the BfArM therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of flupirtine-containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Estonian: BfArM algatas 19. oktoobril 2017 ravimiohutuse järelevalve andmete põhjal direktiivi 2001/83/EÜ artikli 31 kohase esildismenetluse ja palus ravimiohutuse riskihindamise komiteel hinnata nimetatud küsimuste mõju flupirtiini sisaldavate ravimite kasulikkuse ja riski suhtele ning soovitada, kas asjakohased müügiload tuleb säilitada, muuta, peatada või tühistada.
English: These measures were communicated to the relevant healthcare professional (HCP) in a letter and educational materials was implemented to inform prescribers and patients of the risk and associated measures to minimise it.
Estonian: Nendest meetmetest teatati kirja teel asjaomastele tervishoiutöötajatele ja kasutusele võeti teabematerjalid, et teatada sellest riskist ja seotud riskivähendusmeetmetest ravimi määrajaid ja patsiente.
English: In view of the recent study results and as cases of liver injury continue to be reported, the German national competent authority (BfArM) considered that the impact of the risk of liver injury on the benefit-risk balance of these medicinal products and the adequacy of the related risk minimisation measures, should be reviewed.
Estonian: Arvestades hiljutisi uuringuandmeid ning asjaolu, et maksakahjustuse juhtumitest teatatakse jätkuvalt, leidis Saksamaa riiklik pädev asutus (BfArM), et maksakahjustuse riski mõju nende ravimite kasulikkuse ja riski suhtele ning seotud riskivähendusmeetmete adekvaatsus tuleb läbi vaadata.
English: These included the restriction of the maximum treatment duration to two weeks, a contraindication in patients with pre-existing liver disease or taking concomitantly other medication known to cause drug liver injury and weekly monitoring of liver functions.
Estonian: Need olid näiteks ravi kestuse piiramine kuni kahe nädalani, vastunäidustus maksahaigusega patsientidele või kasutamisele samaaegselt koos teiste ravimitega, mis teadaolevalt võivad põhjustada maksa ravimkahjustust, ning iganädalane maksafunktsiooni kontrollimine.
English: Additionally a facilitatory effect on gamma-aminobutyric acid A receptors has been described.
Estonian: Lisaks on kirjeldatud gamma-aminovõihappe A-retseptoreid stimuleerivat toimet.
English: The Committee, as a consequence, considers that the benefit-risk balance of flupirtine-containing medicinal products is no longer favourable.
Estonian: Komitee on seega arvamusel, et flupirtiini sisaldavate ravimite kasulikkuse ja riski suhe ei ole enam positiivne.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for flupirtine-containing medicinal products (see Annex I).
Estonian: • ravimiohutuse riskihindamise komitee arutas direktiivi 2001/83/EÜ artikli 31 kohast menetlust, mis käsitles flupirtiini sisaldavate ravimite (vt I lisa) ravimiohutuse järelevalve andmeid.