FrancophonIA/ELRC3.0 huggingface dataset:
English: Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg
Latvian: Domperidon JJC zetpillen voor volwassenen 60 mg
English: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon domperidone DOMPERIDONE ARROW 10 mg, comprimé pelliculé
Latvian: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
English: LABORATORI ALTER S.R.L.
Latvian: LABORATORI ALTER S.R.L. Via Egadi 7
English: United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Latvian: Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom domperidone maleate
English: Domperidone Motilium 30 mg Suppositories
Latvian: Motilium 30 mg Suppositories
English: Domperidone EG-10 10 mg tablet
Latvian: Domperidone EG-10 10 mg tablete
English: 10 mg suppository rectal use
Latvian: 10 mg supozitorijs rektālai lietošanai
English: SUBSTIPHARM 8, rue Bellini 75116 Paris France domperidone DOMPERIDONE GERDA 10 mg, comprimé pelliculé
Latvian: SUBSTIPHARM 8, rue Bellini 75116 Paris France
English: Ireland domperidone maleate
Latvian: Roscommon, Ireland domperidone maleate
English: 49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible
Latvian: 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: MEDICAMENT 10 mg, comprimé orodispersible
Latvian: OROPERIDYS 10 mg, comprimé orodispersible
English: Domperidone Domperidon Bellwood 10 mg, tabletten
Latvian: Domperidon Bellwood 10 mg, tabletten
English: Via Pavia 6 20136 Milano Italy
Latvian: CRINOS S.P.A. Via Pavia 6 20136 Milano Italy
English: Domperidone Domperidon Sandoz 10 mg, tabletten
Latvian: Domperidon Sandoz 10 mg, tabletten
English: 30 mg suppository rectal use
Latvian: 30 mg supozitorijs rektālai lietošanai
English: Domperidone Motilium filmomhulde tabletten 10 mg
Latvian: Motilium filmomhulde tabletten 10 mg
English: Belgium domperidone Motilium-30 supp 30 mg suppository rectal use
Latvian: Motilium-30 supp 30 mg supozitorijs rektālai lietošanai
English: Domperidone Motilium instant
Latvian: Motilium instant
English: Austria domperidone Motilium 60 mgZäpfchen
Latvian: Motilium 60 mgZäpfchen
English: Domperidone Nauzelin 1 mg/ml suspensión oral
Latvian: Nauzelin 1 mg/ml suspensión oral
English: Domperidone DOMERID 10mg Tablets.
Latvian: DOMERID 10mg Tablets.
English: Domperidone Domperidon Actavis 10 mg, omhulde tabletten
Latvian: Domperidon Actavis 10 mg, omhulde tabletten
English: Domperidone Domperidon PCH 10, filmomhulde tabletten 10 mg
Latvian: Domperidon PCH 10, filmomhulde tabletten 10 mg
English: Domperidone Domperidon Faribérica 10 mg, tabletten
Latvian: Domperidon Faribérica 10 mg, tabletten
English: Estrada Consiglieri Pedroso, 69 AQueluz de Baixo
Latvian: Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2730-055 Barcarena Portugal
English: Austria domperidone Motilium 30 mgZäpfchen
Latvian: Motilium 30 mgZäpfchen
English: Domperidone Domperidon 10 PCH, filmomhulde tabletten 10 mg
Latvian: Domperidon 10 PCH, filmomhulde tabletten 10 mg
English: WD18 9SS
Latvian: DE14 2WX
English: Domperidone Domperidon 10 mg Pharmachemie, tabletten
Latvian: Domperidon 10 mg Pharmachemie, tabletten
English: Domperidone Motilium 1 mg/ ml suspensión oral
Latvian: Motilium 1 mg/ ml suspensión oral
English: Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
Latvian: DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
English: Domperidone DOMPERIDONE DR. REDDY'S
Latvian: DOMPERIDONE DR.
English: 92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose
Latvian: 92787 Issy-les-Moulineaux Cedex 9
English: Domperidone Domperidon CF 10 mg, tabletten
Latvian: Domperidon CF 10 mg, tabletten
English: Domperidone PERIDON
Latvian: Domperidona Labesfal
English: 5 mg effervescent granules
Latvian: 5 mg putojošās granulas iekšķīgai lietošanai
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Latvian: Heizel Esplanade b22 1020 Brussels Belgium
English: Austria domperidone Motilium 10 mgZäpfchen
Latvian: Motilium 10 mgZäpfchen
English: Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Latvian: Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras 1070-274 Lisboa Portugal
English: Domperidone Domperidon Accord 10 mg, tabletten
Latvian: Domperidon Accord 10 mg, tabletten
English: 25 83607 Holzkirchen Germany
Latvian: 2 78467 Konstanz Germany
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
Latvian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
English: 75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
Latvian: DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable.
English: Domperidone Domperidon Mylan 10 mg, tabletten
Latvian: Domperidon Mylan 10 mg, tabletten
English: Domperidone Domperidon Mdq 10 mg, tabletten
Latvian: Domperidon Mdq 10 mg, tabletten
English: 4230 Skaelskoer Denmark domperidone Domperidon "Alternova"
Latvian: 4230 Skaelskoer Denmark
English: Domperidone Domperidon Actavis 10 mg, tabletten
Latvian: Domperidon Actavis 10 mg, tabletten
English: Domperidone GERDI
Latvian: Domperidona Germed
English: Via Cantù 11
Latvian: Laarstraat 16
English: UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania domperidone Motilium 10 mg filmcoated tablets
Latvian: 18A LT-08104 Vilnius Lithuania
English: Domperidone Domperidon Pharmacin 10 mg, tabletten
Latvian: Domperidon Pharmacin 10 mg, tabletten
English: Limassol CY-3505 Cyprus domperidone Costi 10mg Film coated tablets
Latvian: Limassol CY-3505 Cyprus
English: Domperidone Motilium 1mg/ml Oral Suspension
Latvian: Domperidone 1mg/ml Oral Suspension
English: Via Manunzio 7
Latvian: DOC GENERICI S.R.L. Via Manunzio 7
English: Domperidone Domperidon STADA 10 mg tabletten
Latvian: Domperidon STADA 10 mg Tabletten
English: Domperidone DOMPERIDONE ABC 10 mg tablet
Latvian: DOMPERIDONE ABC 10 mg tablete
English: Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé
Latvian: Sanofi-Aventis France 1-13, boulevard Romain Rolland
English: 75116 Paris domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
Latvian: DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
English: Domperidone Domperidon Sofar 10 mg, tabletten
Latvian: Domperidon Sofar 10 mg, tabletten
English: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
Latvian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
English: 92654 Boulogne Cedex France
Latvian: 92931 Paris La Défense Cedex France
English: Domperidone Domperidon Kela 10 mg, tabletten
Latvian: Domperidon Kela 10 mg, tabletten
English: Domperidone Domperidon Actavis 10 mg tablet
Latvian: Domperidon Actavis 10 mg tablets
English: Janssen-Cilag
Latvian: Janssen-Cilag Kft.
English: 2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet
Latvian: 2770-229 Paço de Arcos Portugal
English: 75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Latvian: DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
English: Belgium Kela Pharma nv Industriepark 68
Latvian: Kela Pharma nv Industriepark 68 9100 Sint-Niklaas Belgium
English: Domperidone Domperidon 10 mg PCH, tabletten
Latvian: Domperidon 10 mg PCH, tabletten
English: 20 mg effervescent granules
Latvian: 20 mg putojošās granulas iekšķīgai lietošanai
English: Hungary domperidone Domperidon-EP 10 mg tabletta
Latvian: Domperidon-EP 10 mg tabletta
English: LABORATORIOS DR. ESTEVE, S.A. Avda.
Latvian: Labesfal Genéricos, S.A Avenida Dr. Afonso Costa,
English: Domperidone mylan 10 mg film-coated tablet
Latvian: DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
English: Motilium Instants 10 mg orodispersible tablet oral use
Latvian: Motilium Instants 10 mg mutē disperģējamā tablete
English: 10 mg effervescent granules
Latvian: MOTILIUM 10 mg, granulés effervescents en sachet-dose
English: Domperidone OROPERIDYS 10 mg 10 mg tablet
Latvian: OROPERIDYS 10 mg 10 mg tablete
English: United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday Court
Latvian: Focus Pharmaceuticals Limited Unit 5, Faraday Court First Avenue, Centrum 100 Burton Upon Trent, Staffordshire
English: Domperidone Motilium 10mg FilmCoated Tablets
Latvian: Motilium 10mg FilmCoated Tablets
English: Domperidone Oroperidys
Latvian: Oroperidys
English: Domperidone Domperidon 10 mg, tabletten
Latvian: Domperidon 10 mg, tabletten
English: 10 mg orodispersible tablet oral use
Latvian: Oroperidys 10 mg orodispersible tablets
English: 10 mg coated tablet
Latvian: Costi 10mg Film coated tablets
English: Einnehmen
Latvian: RIGES
English: Domperidone EG 10 mg tablet
Latvian: Domperidone EG 10 mg tablete
English: Domperidone Domperidon 10 mg tabletten
Latvian: Domperidon 10 mg tabletten
English: Healthypharm B.V. Nieuwe Donk 3
Latvian: Healthypharm B.V.
English: Domperidone DOMPERIDONE FG 10 mg tablet
Latvian: DOMPERIDONE FG 10 mg tablete
English: Austria domperidone Motilium 1 mg/mlSuspension zum
Latvian: Motilium 1 mg/mlSuspension zum Einnehmen
English: 5 mg/5 ml oral solution
Latvian: 5 mg/5 ml suspensija iekšķīgai lietošanai
English: DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use
Latvian: DOMPERIDONE OROPERIDYS 10 mg 10 mg mutē disperģējamā tablete
English: Belgium domperidone Motilium pediatrie 1 mg/ml oral suspension oral use
Latvian: Motilium pediatrie 1 mg/ml suspensija iekšķīgai lietošanai
English: 5 mg chewable tablet
Latvian: 5 mg putojošā tablete
English: Samenwerkende
Latvian: NEOPERIDYS
English: 20 mg orodispersible tablet oral use
Latvian: 20 mg mutē disperģējamā tablete
English: 1 mg/ml oral suspension oral use
Latvian: 1 mg/ml suspensija iekšķīgai lietošanai
English: PIERRE FABRE PHARMA S.R.L.
Latvian: AbZ Pharma GmbH Graf-Arco-Str.
English: Via Winckelmann 1 20146 Milano Italy
Latvian: PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano
English: Austria domperidone Motilium 10 mgFilmtabletten
Latvian: Motilium 10 mgFilmtabletten
English: 53859 Niederkassel-Mondorf Germany
Latvian: 53859 Niederkassel-Mondorf Vācija
English: Orchard Business Centre St Barnabas Close Allington Maidstone Kent ME16 OJZ England
Latvian: Orchard Business Centre St Barnabas Close Allington Maidstone Kent ME16 OJZ Anglija
English: 87 Avenue de la Constitution B-1083 Brussel Belgium
Latvian: 87 Avenue de la Constitution B-1083 Brussel Beļģija
English: Dubrova 308 52220 Labin Croatia
Latvian: 52220 Labin Horvātija
English: Septodont NV-SA 87 Avenue de la Constitution B-1083 Bruxelles Belgium
Latvian: Septodont NV-SA 87 Avenue de la Constitution B-1083 Bruxelles Beļģija
English: John Tsaprazis SA 157 Michalakopoulou Str. 11527, Athens Greece
Latvian: John Tsaprazis SA 157 Michalakopoulou Str.
English: 3% without vasoconstrictor
Latvian: 3% bez vazokonstriktora
English: Infiltration Perineural use
Latvian: Infiltrācijai Perineirālai lietošanai
English: Periodontal use
Latvian: Perineirālai lietošanai
English: Dental use Perineural use Submucosal use Infiltration
Latvian: Lietošanai zobārstniecībā Perineirālai lietošanai Submukozālai lietošanai Infiltrācijai
English: Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés Cedex
Latvian: Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-desFossés Cedex Francija
English: Perineural use Infiltration
Latvian: Perineirālai lietošanai Infiltrācijai
English: Spécialités Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Latvian: Spécialités Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France
Latvian: Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Perineural use Submucosal use
Latvian: Perineirālai lietošanai Submukozālai lietošanai
English: Dental use Perineural use
Latvian: Lietošanai zobārstniecībā Perineirālai lietošanai
English: technology'.
Latvian: tehnoloģiju”.
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Latvian: Turklāt Komiteja apšaubīja ierosināto zāļu sterilizācijas metodi.
English: EMA/430531/2016 Rev 1 EMEA/H/C/003846
Latvian: EMA/430531/2016 EMEA/H/C/003846
English: What is Kyndrisa?
Latvian: Kas ir Kyndrisa?
English: Kyndrisa is a medicine that contains the active substance drisapersen.
Latvian: Kyndrisa ir zāles, kas satur aktīvo vielu drisapersēnu.
English: This medicine works by ‘exon 51 skipping
Latvian: Šīs zāles darbojas ar „51. eksona izlaišanas
English: It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood.
Latvian: Tā izraisa pakāpenisku vājumu un muskuļu darbības zudumu, un parasti pusaudža gados vai agrīnā pusaudža vecumā iestājas nāve.
English: It was to be available as a solution for injection under the skin.
Latvian: Bija paredzēts, ka tās būs pieejamas kā suspensija zemādas injekcijām.
English: Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy.
Latvian: Kyndrisa tika pētītas trijos pētījumos, kopumā iesaistot 290 pacientus ar Dišēna muskuļu distrofiju.
English: Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6.
Latvian: Dišēna muskuļu distrofija ir nopietna ģenētiska slimība, kas galvenokārt skar zēnus un ko parasti diagnosticē pirms 6 gadu vecuma.
English: The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment.
Latvian: Pētījumos salīdzināja Kyndrisa iedarbību ar placebo (fiktīvu ārstēšanu), un galvenais efektivitātes rādītājs bija izmaiņas attālumā, kādu spēja noiet pacients sešās minūtēs pēc 24 vai 48 ārstēšanas nedēļām.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Latvian: Pieteikums tika atsaukts, kad CHMP bija izvērtējusi uzņēmuma sākotnēji iesniegtos dokumentus un sagatavojusi jautājumu sarakstu.
English: The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa.
Latvian: Uzņēmums norādīja, ka ir paredzējis pārtraukt zāļu ražošanu, tomēr tas neplāno pārtraukt sadarbību ar ārstiem, pacientiem un vietējās pārvaldes iestādēm, lai ļautu pašlaik ārstētajiem pacientiem saņemt zāļu Kyndrisa atlikumus.
English: The Committee considered that data from the clinical studies did not sufficiently demonstrate a beneficial effect of Kyndrisa: the main study did not show any benefit in patients with the condition, while two other studies failed to consistently show a beneficial effect.
Latvian: Komiteja uzskatīja, ka klīnisko pētījumu dati nav pietiekami, lai pierādītu Kyndrisa labvēlīgo ietekmipamatpētījums neuzrādīja nekādu ieguvumu pacientiem ar šādu veselības stāvokli, savukārt divos citos pētījumos neizdevās konsekventi pierādīt labvēlīgo ietekmi.
English: Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications.
Latvian: Turklāt zāļu lietošanas drošības profils netika uzskatīts par apmierinošu, jo īpaši sakarā ar persistējošu reakciju risku injekcijas vietā (piemēram, pietūkums, iekaisums un ulcerācija), kam var būt negatīva ietekme uz dzīves kvalitāti, un trombocitopēnijas (samazināta trombocītu daudzuma asinīs) risku, kas var izraisīt pacientiem nopietnas hemorāģiskas komplikācijas.
English: Kyndrisa was expected to be used for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older who are able to walk and whose disease is due to certain genetic mutations (defects) that can be treated with ‘exon 51 skipping technology'.
Latvian: Kyndrisa bija paredzēts lietot Dišēna muskuļu distrofijas ārstēšanai tādiem pacientiem no 5 gadu vecuma, kuri spēj staigāt un kuru slimība ir saistīta ar noteiktām ģenētiskām mutācijām (defektiem), ko var ārstēt ar „51. eksona izlaišanas tehnoloģiju”.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Kyndrisa did not outweigh its risks.
Latvian: Tāpēc atsaukšanas brīdī CHMP uzskatīja, ka zāļu Kyndrisa ieguvumi nepārsniedz to radīto risku.
English: On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy.
Latvian: 2016. gada 31. maijā BioMarin International Limited oficiāli informēja Cilvēkiem paredzēto zāļu komiteju (CHMP) par savu lēmumu atsaukt pieteikumu Kyndrisa reģistrācijas apliecības saņemšanai.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it would not be able to address the CHMP concerns regarding the results of the clinical studies within the expected timeframe.
Latvian: Uzņēmuma vēstulē, kurā tas informē aģentūru par pieteikuma atsaukšanu, ir norādīts, ka atsaukšana saistīta ar to, ka uzņēmums nespēs atrisināt CHMP paustās bažas par klīnisko pētījumu rezultātiem noteiktajā termiņā.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Kyndrisa could not have been approved for the treatment of Duchenne muscular dystrophy.
Latvian: Pamatojoties uz izskatītajiem datiem un uzņēmuma atbildēm uz CHMP jautājumiem, atsaukšanas brīdī CHMP bija izteikusi bažas un bija sagatavojusi iepriekšēju slēdzienu par to, ka Kyndrisa nevarētu tikt apstiprināts Dišēna muskuļu distrofijas ārstēšanai.
English: This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein.
Latvian: Šī tehnoloģija darbojas, ļaujot olbaltumvielu sintēzes mehānismam šūnās izlaist noteiktus punktus distrofīna gēnā un sintezēt saīsinātu, daļēji funkcionējošu distrofīna olbaltumvielu.
English: What was Kyndrisa expected to be used for?
Latvian: Kādam nolūkam bija paredzēts lietot Kyndrisa?
English: Duchenne muscular dystrophy is caused by mutations in the gene for the protein dystrophin, which lead to the production of a non-functional dystrophin.
Latvian: Dišēna muskuļu distrofiju izraisa mutācijas olbaltumvielas distrofīna gēnā, kā rezultātā tiek pārtraukta normālas distrofīna olbaltumvielas veidošanās.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues.
Latvian: Novērtējusi uzņēmuma sniegtās atbildes uz pēdējā posma jautājumiem, CHMP konstatēja, ka dažas svarīgas problēmas vēl nav atrisinātas.
English: Kyndrisa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 February 2009 for Duchenne muscular dystrophy.
Latvian: 2009. gada 27. februārī Kyndrisa atzina par zālēm retu slimību ārstēšanai, ko lieto Dišēna muskuļu distrofijas ārstēšanai.
English: How is Kyndrisa expected to work?
Latvian: Kāda ir paredzamā Kyndrisa iedarbība?
English: Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen) EMA/430531/2016
Latvian: EMA/430531/2016
English: 22014 Incheon Republic of Korea
Latvian: 22014 Incheon Korejas Republika
English: Important information:
Latvian: Svarīga informācija:
English: HIT-6 total
Latvian: HIT-6 kopā
English: Not all pack sizes may be available in your country.
Latvian: Ne visi iepakojuma lielumi var būt pieejami Jūsu valstī.
English: Your doctor will discuss and decide with you the most appropriate dosing schedule.
Latvian: Ārsts ar Jums apspriedīsies un izlems Jums vispiemērotāko devu režīmu.
English: This is normal.
Latvian: Tas ir pieņemami.
English: Long-term study (Study 3)
Latvian: Ilgtermiņa pētījums (3. pētījums)
English: The antibody responses were of low titer.
Latvian: Antivielu atbildes reakcija bija ar zemu titru.
English: The treatment benefit should be assessed within 3 months after initiation of treatment.
Latvian: Ieguvums no ārstēšanas jāizvērtē 3 mēnešu laikā pēc ārstēšanas sākuma.
English: More than 1,400 patients were treated for at least 12 months.
Latvian: Vairāk nekā 1400 pacienti tika ārstēti vismaz 12 mēnešus.
English: No safety signal was observed during the 15-month combined treatment period.
Latvian: 15 mēnešu apvienotajā ārstēšanas periodā netika novēroti drošuma signāli.
English: Date of first authorisation: 28 March 2019
Latvian: PIRMĀS REĢISTRĀCIJAS/PĀRREĢISTRĀCIJAS DATUMS Reģistrācijas datums: 2019. gada 28. marts
English: How much and when to inject
Latvian: Cik daudz injicēt un kad veikt injekciju
English: One of these 6 patients developed neutralising antibodies.
Latvian: Vienam no šiem 6 pacientiem izveidojās neitralizējošas antivielas.
English: No safety data are available in these patients.
Latvian: Dati par drošumu šiem pacientiem nav pieejami.
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.
Latvian: Tomēr ir zināms, ka cilvēka IgG izdalās pienā pirmajās dienās pēc dzemdībām, bet drīz pēc tam samazinās līdz zemai koncentrācijai, tāpēc šajā īsajā laika periodā nevar izslēgt risku ar krūti barotiem zīdaiņiem.
English: Two dosing options are available:
Latvian: Ir pieejamas divas ieteiktās devu izvēles:
English: (Note: When the blue plunger has filled the viewing window you will still be able to see the grey stopper.)
Latvian: (Piezīme: pēc tam, kad zilais virzulis būs aizpildījis aplūkošanas lodziņu, Jūs joprojām varēsiet redzēt pelēko aizbāzni.)
English: AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.
Latvian: AJOVY nav ieteicams lietošanai bērniem un pusaudžiem, kuri jaunāki par 18 gadiem, jo tas nav pētīts šajā vecuma grupā.
English: See section 4.8 for how to report adverse reactions.
Latvian: Skatīt 4.8. apakšpunktu par to, kā ziņot par nevēlamām blakusparādībām
English: Overall, 19% of the patients had previously used topiramate.
Latvian: Pavisam 19% pacientu iepriekš bija lietojuši topiramātu.
English: Mean change a
Latvian: Vidējā izmaiņa a
English: Pharmacotherapeutic group: Not yet assigned.
Latvian: Farmakoterapeitiskā grupa: vēl nav piešķirts.
English: Any further decision to continue treatment should be taken on an individual patient basis.
Latvian: Lēmums par ārstēšanas turpināšanu jāpieņem, pamatojoties uz pacienta individuālo reakciju.
English: 61% of patients completing Study 3 achieved a 50% response in the last month of the study.
Latvian: 61% pacientu, kuri pabeidza 3. pētījumu, sasniedza 50% atbildes reakciju pētījuma pēdējā mēnesī.
English: Your doctor or nurse will explain to you or your caregiver how to give the injection.
Latvian: Ārsts vai medmāsa izskaidros Jums vai Jūsu aprūpētājam, kā veikt injekciju.
English: The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established.
Latvian: AJOVY drošums un efektivitāte, lietojot bērniem un pusaudžiem, kuri jaunāki par 18 gadiem, līdz šim nav pierādīta.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Latvian: Ieteicams vēlāk regulāri pārskatīt nepieciešamību turpināt ārstēšanu.
English: Demographics and baseline disease characteristics were balanced and comparable between the study arms.
Latvian: Demogrāfiskie raksturlielumi un slimības īpašības sākumstāvoklī bija līdzsvarotas un salīdzināmas starp pētījuma grupām.