FrancophonIA/ELRC3.0 huggingface dataset:
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Latvian: Izņēmums ir tādas ļoti bieži (≥ 1/10) novērotas blakusparādības kā miegainība (23,0 %), ekstrapiramidāli traucējumi (18,4 %), akatīzija (16,0 %) un nespēks (11,8 %), kā arī tādas bieži (≥ 1/100 līdz < 1/10) novērotas blakusparādības kā sāpes vēdera augšdaļā, paātrināta sirdsdarbība, ķermeņa masas palielināšanās, ēstgribas pastiprināšanās, muskuļu raustīšanās un diskinēzija.
English: In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 25.6 % and 45.0 %, respectively.
Latvian: Ar šizofrēniju slimojošu pusaudžu (13 - 17 gadi) populācijā, lietojot 5 mg līdz 30 mg aripiprazola līdz 72 mēnešiem ilgi, zems prolaktīna līmenis serumā bija 25,6 % sieviešu (< 3 ng/ml) un 45,0 % vīriešu (< 2 ng/ml).
English: What Aripiprazole Accord tablets contain
Latvian: Ko Aripiprazole Accord tabletes satur
English: Aripiprazole Accord 10 mg/ 30 mg tablets
Latvian: Aripiprazole Accord 10 mg/ 30 mg tabletes
English: In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
Latvian: Divos ilgtermiņa pētījumos, kuros piedalījās ar aripiprazolu ārstēti pusaudži (13 - 17 gadi), kuriem ir šizofrēnija un bipolāri traucējumi, zema prolaktīna līmeņa serumā sastopamība bija 37,0 % sievietēm (< 3 ng/ml) un 59,4 % vīriešiem (< 2 ng/ml).
English: In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (< 2 ng/ml) was 29.5 % and 48.3 %, respectively.
Latvian: Apvienotā pusaudžu šizofrēnijas pacientu populācijā (13 - 17 gadi), kas zāles saņēma līdz 2 gadiem, zema prolaktīna līmeņa serumā biežums sievietēm (< 3 ng/ml) un vīriešiem (< 2 ng/ml) bija attiecīgi 29,5 % un 48,3 %.
English: • weight loss,
Latvian: • ķermeņa masas zudums;
English: Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Latvian: Aripiprazole Accord 15 mg tabletes ir dzeltenā krāsā, apmēram 7,14 mm diametrā, apaļas formas, abpusēji izliektas, neapvalkotas tabletes ar slīpām malām, ar iegravētu "A15" vienā pusē un gludu otru pusi.
English: INFORMATION IN BRAILLE Aripiprazole Accord 30 mg
Latvian: 16. INFORMĀCIJA BRAILA RAKSTĀ Aripiprazole Accord 30 mg
English: Aripiprazole Accord 30 mg tablets: each tablet contains 30 mg of aripiprazole.
Latvian: Aripiprazole Accord 30 mg tabletes: katra tablete satur 30 mg aripiprazola.
English: Aripiprazole Accord 30 mg tablets
Latvian: Aripiprazole Accord 30 mg tabletes
English: Schizophrenia in adolescents aged 15 years and older: the recommended dose for Aripiprazole Accord is 10 mg/day administered on a once-a-day schedule without regard to meals.
Latvian: Šizofrēnija pusaudžiem, vecākiem par 15 gadiem: ieteicamā deva ir Aripiprazole Accord 10 mg/dienā.
English: Pancreatitis Dysphagia
Latvian: Aknu mazspēja
English: INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
Latvian: 16. INFORMĀCIJA BRAILA RAKSTĀ Aripiprazole Accord 5 mg
English: Aripiprazole Accord 10 mg tablets: each tablet contains 10 mg of aripiprazole.
Latvian: Aripiprazole Accord 10 mg tabletes: katra tablete satur 10 mg aripiprazola.
English: In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Latvian: I tipa bipolāri afektīvu traucējumu mānijas epizodes Divos 3 nedēļas ilgos, pielāgojamas devas, placebo kontrolētos monoterapijas pētījumos, kuros bija iesaistīti pacienti ar mānijas vai jauktu epizodi bipolāri afektīvu traucējumu gadījumos, aripiprazols uzrādīja labāku efektivitāti par placebo mānijas simptomu samazināšanā 3 nedēļu periodā.
English: Yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Latvian: Dzeltenas, apmēram 7,14 mm diametrā, apaļas formas, abpusēji izliektas, neapvalkotas tabletes ar slīpām malām, ar iegravētu "A15" vienā pusē un gludu otru pusi.
English: These medicines may increase the risk of side effects or reduce the effect of ARIPIPRAZOLE ACCORD; if you get any unusual symptom taking any of these medicines together with ARIPIPRAZOLE ACCORD you should see your doctor.
Latvian: lietojot jebkuras šīs zāles vienlaicīgi ar Aripiprazole Accord, Jums rodas jebkādi neparasti simptomi, Jums ir jāvēršas pie ārsta.
English: INFORMATION IN BRAILLE Aripiprazole Accord 10 mg
Latvian: 16. INFORMĀCIJA BRAILA RAKSTĀ Aripiprazole Accord 10 mg
English: Pink colored, approximately 9.1 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A30” on one side and another side is plain.
Latvian: Sārtas, apmēram 9,1 mm diametrā, apaļas formas, abpusēji izliektas, neapvalkotas tabletes ar slīpām malām, ar iegravētu "A30" vienā pusē un gludu otru pusi.
English: Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Latvian: Aripiprazole Accord 10 mg tabletes ir sārtā krāsā, apmēram 8,1 mm garas, 4,6 mm platas, modificēta taisnstūra formas, abpusēji izliektas, neapvalkotas tabletes ar iegravētu "A10" vienā pusē un gludu otru pusi.
English: Aripiprazole Accord 5 mg tablets
Latvian: Aripiprazole Accord 5 mg tabletes
English: Aripiprazole Accord 10 mg tablets
Latvian: Aripiprazole Accord 10 mg tabletes
English: Aripiprazole Accord 5 mg tablets: each tablet contains 5 mg of aripiprazole.
Latvian: Aripiprazole Accord 5 mg tabletes: katra tablete satur 5 mg aripiprazola.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1045/005- 30 tablets EU/1/15/1045/006- 100 tablets
Latvian: EU/1/15/1045/005- 30 tabletes EU/1/15/1045/006- 100 tabletes
English: Aripiprazole Accord 15 mg tablets
Latvian: Aripiprazole Accord 15 mg tabletes
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 30 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Accord 30 mg tabletes aripiprazolum
English: Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Latvian: Aripiprazole Accord tablešu ārējais izskats un iepakojums Aripiprazole Accord 5 mg tabletes ir zilā krāsā, apmēram 8,1 mm garas, 4,6 mm platas, modificēta taisnstūra formas, abpusēji izliektas, neapvalkotas tabletes ar iegravētu "A5" vienā pusē un gludu otru pusi.
English: In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.When considering concomitant administration of ketoconazole or other strong CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Latvian: CYP2D6 vājiem metabolizētājiem, lietojot vienlaikus spēcīgus CYP3A4 inhibitorus, aripiprazola līmenis plazmā var būt augstāks salīdzinājumā ar CYP2D6
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole.
Latvian: NOSAUKUMS (-I) UN DAUDZUMS(-I) Katra tablete satur 30 mg aripiprazola.
English: Aripiprazole Accord 15 mg tablets: each tablet contains 15 mg of aripiprazole.
Latvian: Aripiprazole Accord 15 mg tabletes: katra tablete satur 15 mg aripiprazola.
English: Blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Latvian: Zilas, apmēram 8,1 mm garas, 4,6 mm platas, modificēta taisnstūra formas, abpusēji izliektas, neapvalkotas tabletes ar iegravētu "A5" vienā pusē un gludu otru pusi.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 10 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Accord 10 mg tabletes aripiprazolum
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 5 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Accord 5 mg tabletes aripiprazolum
English: Pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Latvian: Sārtas, apmēram 8,1 mm garas, 4,6 mm platas, modificēta taisnstūra formas, abpusēji izliektas, neapvalkotas tabletes ar iegravētu "A10" vienā pusē un gludu otru pusi.
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Accord 15 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Accord 15 mg tabletes aripiprazolum
English: Hepatic impairment
Latvian: Sāpes krūškurvī
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole.
Latvian: NOSAUKUMS (-I) UN DAUDZUMS(-I) Katra tablete satur 15 mg aripiprazola.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of aripiprazole.
Latvian: NOSAUKUMS (-I) UN DAUDZUMS(-I) Katra tablete satur 5 mg aripiprazola.
English: • cardiovascular diseases (diseases of the heart and circulation),, family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Latvian: • netīšas, neregulāras muskuļu kustības, sevišķi sejā; sirds un asinsvadu slimības, sirds un asinsvadu slimība agrāk kādam ģimenes loceklim, insults vai mikroinsults, patoloģiskas asinsspiediena izmaiņas;
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of aripiprazole.
Latvian: NOSAUKUMS (-I) UN DAUDZUMS(-I) Katra tablete satur 10 mg aripiprazola.
English: Aripiprazole Accord is for oral use.
Latvian: Lietošanas veids Zāles Aripiprazole Accord ir paredzētas iekšķīgai lietošanai.
English: EU/1/15/1045/001 14x1 tablets EU/1/15/1045/002 28x1 tablets EU/1/15/1045/023 49x1 tablets EU/1/15/1045/003 56x1 tablets EU/1/15/1045/004 98x1 tablets
Latvian: EU/1/15/1045/001 14x1 tabletes EU/1/15/1045/002 28x1 tabletes EU/1/15/1045/023 49x1 tabletes EU/1/15/1045/003 56x1 tabletes EU/1/15/1045/004 98x1 tabletes
English: EU/1/15/1045/019 14x1 tablets EU/1/15/1045/020 28x1 tablets EU/1/15/1045/026 49x1 tablets EU/1/15/1045/021 56x1 tablets EU/1/15/1045/022 98x1 tablets
Latvian: EU/1/15/1045/019 14x1 tabletes EU/1/15/1045/020 28x1 tabletes EU/1/15/1045/026 49x1 tabletes EU/1/15/1045/021 56x1 tabletes EU/1/15/1045/022 98x1 tabletes
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
Latvian: 56-99 gadi) gados vecākiem pacientiem ar psihozi, kas saistīta ar Alcheimera slimību, novēroja, ka tiem pacientiem, kuri tika ārstēti ar aripiprazolu, palielinājās mirstības risks, salīdzinot ar placebo grupu.
English: EU/1/15/1045/013 14x1 tablets EU/1/15/1045/014 28x1 tablets EU/1/15/1045/025 49x1 tablets EU/1/15/1045/015 56x1 tablets EU/1/15/1045/016 98x1 tablets
Latvian: EU/1/15/1045/013 14x1 tabletes EU/1/15/1045/014 28x1 tabletes EU/1/15/1045/025 49x1 tabletes EU/1/15/1045/015 56x1 tabletes EU/1/15/1045/016 98x1 tabletes
English: EU/1/15/1045/007 14x1 tablets EU/1/15/1045/008 28x1 tablets EU/1/15/1045/024 49x1 tablets EU/1/15/1045/009 56x1 tablets EU/1/15/1045/010 98x1 tablets
Latvian: EU/1/15/1045/007 14x1 tabletes EU/1/15/1045/008 28x1 tabletes EU/1/15/1045/025 49x1 tabletes EU/1/15/1045/009 56x1 tabletes EU/1/15/1045/010 98x1 tabletes
English: INFORMATION IN BRAILLE Aripiprazole Accord 15 mg 17.
Latvian: 16. INFORMĀCIJA BRAILA RAKSTĀ Aripiprazole Accord 15 mg
English: Each 5 mg tablet contains 63 mg lactose (as monohydrate).
Latvian: Katra 5 mg tablete satur 63 mg laktozes (monohidrāta veidā) Aripiprazole Accord 10 mg tabletes Katra tablete satur 10 mg aripiprazola (Aripiprazolum).
English: Constipation Dyspepsia Nausea Salivary hypersecretion Vomiting
Latvian: Akatīzija Ekstrapiramidāli traucējumi Tremors Galvassāpes Sedācija Miegainība Reibonis
English: Each 15 mg tablet contains 88 mg lactose (as monohydrate).
Latvian: Katra 15 mg tablete satur 88 mg laktozes (monohidrāta veidā) Aripiprazole Accord 30 mg tabletes Katra tablete satur 30 mg aripiprazola (Aripiprazolum).
English: Insomnia Anxiety Restlessness
Latvian: Bezmiegs Trauksme Nemiers
English: The withdrawal letter can be found here.
Latvian: Atsaukuma vēstule ir atrodama šeit.
English: EMEA/H/C/000169/WS/132/G
Latvian: EMEA/H/C/000169/WS/132/G EMEA/H/C/000255/WS/132/G
English: What was the recommendation of the CHMP at that tim
Latvian: Kāds bija CHMP ieteikums tajā laikā?
English: This means that the CHMP had eval documentation provided by the company and formulated lists of questions.
Latvian: Tas nozīmē, ka CHMP bija novērtējusi uzņēmuma iesniegtos dokumentus un sagatavojusi jautājumu sarakstu.
English: The Committee therefore considered that the pharmacokinetic data were not sufficient to draw conclusions on the effectiveness of the patch and that additional data would be required.
Latvian: Tāpēc Komiteja uzskatīja, ka farmakokinētikas dati nav pietiekami, lai varētu izdarīt secinājumus par plākstera efektivitāti un ka būtu nepieciešami papildu dati.
English: 11 April 2012
Latvian: 2012. gada 11. aprīlis EMA/226251/2012
English: About half of the patients took the capsule, and half were tre for 76 weeks.
Latvian: Aptuveni puse pacientu 76 nedēļas lietoja kapsulas, bet pusi pacientu ārstēja ar plāksteriem.
English: es this withdrawal have for patients in clinical trials?
Latvian: Kādas sekas šis atsaukums radīs pacientiem, kuri piedalās klīniskajos pētījumos?
English: The full European Public Assessment Report for Prometax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Latvian: Pilns Prometax Eiropas Publiskā novērtējuma ziņojums ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The full European Public Assessment Report for Exelon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Latvian: Pilns Exelon Eiropas Publiskā novērtējuma ziņojums ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: y informed the CHMP that there are no consequences for patients currently included in clinical trials with Exelon or Prometax.
Latvian: Uzņēmums informēja CHMP, ka tas nerada sekas pacientiem, kuri pašlaik piedalās Exelon vai Prometax klīniskajos pētījumos.
English: Exelon and Prometax are medicines containing the active substance rivastigmine.
Latvian: Exelon un Prometax ir zāles, kas satur aktīvo vielu rivastigmīnu.
English: a clinical trial and need more information about your treatment, contact the doctor who is
Latvian: Ja Jūs pašreiz piedalāties klīniskajā pētījumā un vēlaties saņemt plašāku informāciju par terapiju, jautājiet ārstam, kurš Jums to nodrošina.
English: What did the company present to support its application?
Latvian: Kā uzņēmums pamatoja pieteikuma atsaukšanu?
English: The company had presented pharmacokinetic data showing that, when using the patch, rivastigmine levels in patients with Parkinson's disease were similar to the levels seen in patients with Alzheimer's, but the CHMP noted that the dementia in the two diseases was different and could respond differently to treatment.
Latvian: Uzņēmums bija iesniedzis farmakokinētikas datus, kas apliecina, ka, lietojot šo plāksteri, rivastigmīna līmenis pacientiem ar Pārkinsona slimību bija līdzīgs kā pacientiem ar Alcheimera slimību, bet CHMP ņēma vērā, ka demence šo divu slimību gadījumā ir atšķirīga un pacientiem reakcija uz ārstēšanu var būt atšķirīga.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Exelon/Prometax transdermal patch in the treatment of mild to moderately severe dementia associated with Parkinson's disease were uncertain and did not outweigh its risks.
Latvian: Tāpēc atsaukšanas brīdī CHMP uzskatīja, ka Exelon/Prometax transdermālo plāksteru ieguvumi vieglas līdz vidēji smagas ar Pārkinsona slimību saistītas demences ārstēšanā nav droši un nepārsniedz to radīto risku.
English: s of the medicine can be entia, a progressive lly affects memory, intellectual ability and behaviour.
Latvian: Visas zāļu formas var izmantot, lai ārstētu pacientus ar vieglu līdz vidēji smagu Alcheimera demenci - progresējošu galvas smadzeņu bojājumu, kas pakāpeniski ietekmē atmiņu, intelektuālās spējas un uzvedību.
English: The transdermal patches of Exelon and Prometax were also expected to be used to treat mild to moderately severe dementia associated with Parkinson's disease, which can already be treated using the capsules and oral solution.
Latvian: Arī Exelon un Prometax transdermālos plāksterus bija paredzēts lietot, lai ārstētu vieglu līdz vidēji smagu demenci saistībā ar Pārkinsona slimību, kuras ārstēšanai jau var izmantot kapsulas un šķīdumu iekšķīgai lietošanai.
English: What are Exelon and Prometax?
Latvian: Kas ir Exelon un Prometax?
English: uated the er the CHMP had o the questions, there were still some unresolved issues.
Latvian: Novērtējusi uzņēmuma sniegtās atbildes uz pēdējā posma jautājumiem, CHMP konstatēja, ka dažas problēmas vēl nav atrisinātas.
English: How far into the evaluation was the applicatio
Latvian: Kurā pieteikuma vērtēšanas posmā pieteikumu atsauca?
English: The transdermal patches are expected to work in the same way as the capsules patients with dementia associated with Parkinson's disease, certain nerve cells die i resulting in low levels of the neurotransmitter acetylcholine (a substance that allo communicate with each other).
Latvian: Pacientiem, kuriem ir ar Pārkinsona slimību saistīta demence, noteiktas nervu šūnas galvas smadzenēs iet bojā, kā rezultātā neiromediatora acetilholīna (vielas, kas ļauj nervu šūnām savā starpā sazināties) līmenis pazeminās.
English: The active substance in Exelon and Prometax, ri blocking the enzymes that break down acetylcholine: acetylcholin By blocking these enzymes, rivastigmine allows levels of acetyl
Latvian: Exelon un Prometax aktīvā viela rivastigmīns darbojas, bloķējot enzīmus, kas noārda acetilholīnu: acetilholīnesterāzi un butirilholīnesterāzi.
English: capsules, an oral solution and transdermal patches (patches tha Exelon and Prometax have been authorised in the EU since May 1998.
Latvian: Exelon un Prometax Eiropas Savienībā ir reģistrētas kopš 1998. gada maija.
English: choline to be increased in the brain, helping to reduce the symptoms of dementia in patients with Parkinson's disease.
Latvian: Bloķējot šos enzīmus, rivastigmīns ļauj galvas smadzenēs palielināties acetilholīna līmenim, kas palīdz mazināt demences simptomus pacientiem ar Pārkinsona slimību.
English: Based on the review of the data and the company's response to the CHMP lists time of the withdrawal, the CHMP had some concerns and was of the provisional o transdermal patch could not have been approved for the treatment of mild to
Latvian: Pamatojoties uz izskatītajiem datiem un uzņēmuma atbildēm uz CHMP jautājumu sarakstu, atsaukšanas brīdī CHMP bija daži iebildumi, un CHMP tobrīd atzina, ka transdermālos plāksterus nevarēja apstiprināt vieglas līdz vidēji smagas ar Pārkinsona slimību saistītas demences ārstēšanai.
English: The capsules and oral solution can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Latvian: Kapsulas un šķīdumu iekšķīgai lietošanai var lietot arī vieglas līdz vidēji smagas demences ārstēšanai pacientiem ar Pārkinsona slimību.
English: The Committee was concerned that the new study was not sufficient to conclude on of the patch in patients with dementia associated with Pa e the reasons given by the company for withdrawing the d that it decided to withdraw the application after the CHMP de on a favourable approval additional data was required, which could not be generated within the allowed timeframe.
Latvian: Oficiālajā vēstulē uzņēmums norādīja, ka ir pieņēmis lēmumu atsaukt pieteikumu pēc tam, kad CHMP norādījusi, ka pozitīva apstiprināšanas lēmuma pieņemšanai ir nepieciešami papildu dati, kurus nav iespējams iegūt atļautajā termiņā.
English: The company presented the results of a study designed to assess the long-t and transdermal patch in 583 patients with mild to moderately severe dementia ass Parkinson's disease.
Latvian: Pētījums bija veidots, lai novērtētu kapsulu un transdermālo plāksteru ilgtermiņa ietekmi 583 pacientiem, kuriem ir ar Pārkinsona slimību saistīta viegla līdz vidēji smaga demence.
English: On 14 March 2012, Novartis Europ and Prometax, to add the use of the transdermal patch for the treatment of mild to dementia in patients with Parkinson's disease.
Latvian: Novartis Europharm Ltd. 2012. gada 14. martā oficiāli informēja Cilvēkiem paredzēto zāļu komiteju (CHMP) par savu lēmumu atsaukt Exelon un Prometax indikāciju paplašināšanas pieteikumu ar mērķi pievienot transdermālā plākstera lietošanu vieglas līdz vidēji smagas demences ārstēšanai pacientiem ar Pārkinsona slimību.
English: The company also presented a ‘pharmacokinetic' analysis of the way rivastigmine from the patch is handled in the body th what is seen n when it was withdrawn?
Latvian: Uzņēmums iesniedza arī ”farmakokinētisku” analīzi, raksturojot veidu, kā rivastigmīns no plākstera nokļūst un darbojas organismā, ja to lieto pacientiem, kuriem ir ar Pārkinsona slimību saistīta demence, salīdzinājumā ar lietošanu pacientiem ar Alcheimera demenci.
English: They are available as t deliver the medicine across the skin).
Latvian: Tās ir pieejamas kā kapsulas, šķīdums iekšķīgai lietošanai un transdermālie plāksteri (plāksteri, ar kuru palīdzību zāles ievada caur ādu).
English: erm effects of the capsule ociated with ated with the patch, he capsules, but the company later extended its aim to include the assessment of the benefits and risks of the ase.
Latvian: Šā pētījuma sākotnējais nolūks bija novērtēt kapsulu ilgtermiņa drošumu, bet vēlāk uzņēmums tā mērķi paplašināja, iekļaujot transdermālo plāksteru ieguvumu un riska vērtēšanu, ārstējot ar Pārkinsona slimību saistītu demenci.
English: How are Exelon and Prometax expected to work?
Latvian: Kāda ir paredzamā Exelon un Prometax iedarbība?
English: What is happening with Exelon and Prometax in their authorised ised indications.
Latvian: Kas notiek ar Exelon un Prometax apstiprinātajām indikācijām?
English: What were Exelon and Prometax expected to be used for?
Latvian: Kādam nolūkam bija paredzēts lietot Exelon un Prometax?
English: Adopted at the 3-6 July 2017 PRAC
Latvian: Pieņemts PRAC sēdē 2017. gada 3.-6. jūlijā
English: For all epoetins
Latvian: Attiecībā uz visiem epoetīniem
English: For all epoetins - 4.4.
Latvian: Attiecībā uz visiem epoetīniem - 4.4.
English: <Product name> tonicity: XXX
Latvian: <Zāļu nosaukums> toniskums: XXX
English: For darbepoetin alfa:
Latvian: Attiecībā uz alfa darbepoetīnu:
English: When renal crisis is suspected, blood pressure should be carefully controlled.
Latvian: Ja ir aizdomas par renālo krīzi, rūpīgi jākontrolē asinsspiediens.
English: Scleroderma renal crisis
Latvian: Sklerodermijas renālā krīze
English: Adverse reaction (MedDRA term)
Latvian: Nevēlamā blakusparādība (MedDRA termins)