FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
Latvian: EU/1/15/1029/015 10 tabletes EU/1/15/1029/016 14 tabletes EU/1/15/1029/017 16 tabletes EU/1/15/1029/018 28 tabletes EU/1/15/1029/019 30 tabletes EU/1/15/1029/020 35 tabletes EU/1/15/1029/021 56 tabletes EU/1/15/1029/022 70 tabletes EU/1/15/1029/023 14 x 1 tabletes EU/1/15/1029/024 28 x 1 tabletes EU/1/15/1029/025 49 x 1 tabletes EU/1/15/1029/026 56 x 1 tabletes EU/1/15/1029/027 98 x 1 tabletes
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
Latvian: Aripiprazole Sandoz 5 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Sandoz 30 mg tabletes aripiprazole
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Sandoz 10 mg tabletes aripiprazole
English: EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
Latvian: EU/1/15/1029/001 10 tabletes EU/1/15/1029/002 14 tabletes EU/1/15/1029/003 16 tabletes EU/1/15/1029/004 28 tabletes EU/1/15/1029/005 30 tabletes EU/1/15/1029/006 35 tabletes EU/1/15/1029/007 56 tabletes EU/1/15/1029/008 70 tabletes EU/1/15/1029/009 14 x 1 tabletes EU/1/15/1029/010 28 x 1 tabletes EU/1/15/1029/011 49 x 1 tabletes EU/1/15/1029/012 56 x 1 tabletes EU/1/15/1029/013 98 x 1 tabletes
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
Latvian: 16. INFORMĀCIJA BRAILA RAKSTĀ Kārbiņa: Aripiprazole Sandoz 15 mg
English: Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Latvian: Aripiprazole Sandoz 5 mg tabletes Laktozes monohidrāts Kukurūzas ciete
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: What Aripiprazole Sandoz tablets contain
Latvian: Ko Aripiprazole Sandoz satur
English: What Aripiprazole Sandoz tablets look like and contents of the pack´
Latvian: Aripiprazole Sandoz ārējais izskats un iepakojums
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Sandoz 5 mg tabletes aripiprazole
English: • rapid heartbeat, agitation/aggressiveness, problems with speech.
Latvian: Pacientiem, kas ir lietojuši pārāk daudz aripiprazola, ir bijuši šādi simptomi: strauja sirdsdarbība, uzbudinājums/agresivitāte, runas problēmas;
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Sandoz 20 mg tabletes aripiprazole
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
Latvian: 12. REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/15/1029/028
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
Latvian: hidroksipropilceluloze, magnija stearāts, indigo karmīna (E132) alumīnija laka.
English: EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
Latvian: EU/1/15/1029/029 10 tabletes EU/1/15/1029/030 14 tabletes EU/1/15/1029/031 16 tabletes EU/1/15/1029/032 28 tabletes EU/1/15/1029/033 30 tabletes EU/1/15/1029/034 35 tabletes EU/1/15/1029/035 56 tabletes EU/1/15/1029/036 70 tabletes EU/1/15/1029/037 14 x 1 tabletes EU/1/15/1029/038 28 x 1 tabletes EU/1/15/1029/039 49 x 1 tabletes EU/1/15/1029/040 56 x 1 tabletes EU/1/15/1029/041 98 x 1 tabletes
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
Latvian: 12. REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/15/1029/014
English: EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
Latvian: EU/1/15/1029/048 10 tabletes EU/1/15/1029/049 14 tabletes EU/1/15/1029/050 16 tabletes EU/1/15/1029/051 28 tabletes EU/1/15/1029/052 30 tabletes EU/1/15/1029/053 35 tabletes EU/1/15/1029/054 56 tabletes EU/1/15/1029/055 70 tabletes EU/1/15/1029/056 14 x 1 tabletes EU/1/15/1029/057 28 x 1 tabletes EU/1/15/1029/058 49 x 1 tabletes EU/1/15/1029/059 56 x 1 tabletes EU/1/15/1029/060 98 x 1 tabletes
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
Latvian: ZĀĻU NOSAUKUMS Aripiprazole Sandoz 15 mg tabletes aripiprazole
English: • pain killers (such as tramadol and pethidine) used for pain relief
Latvian: Vadošo zīmolu (Abilify un Abilify Maintena)
English: Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets)
Latvian: Aripiprazole Sandoz 5 mg tabletes EU/1/15/1029/001 (10 tabletes) EU/1/15/1029/002 (14 tabletes) EU/1/15/1029/003 (16 tabletes) EU/1/15/1029/004 (28 tabletes) EU/1/15/1029/005 (30 tabletes) EU/1/15/1029/006 (35 tabletes) EU/1/15/1029/007 (56 tabletes)
English: Constipation Dyspepsia Nausea
Latvian: Bezmiegs Trauksme Nemiers
English: Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).The safety profile in a 26-week open-label extension trial was similar to that observed in the short-term, placebo-controlled trial.
Latvian: Bieži (≥ 1/100, < 1/10) tika ziņots par sausumu mutē, palielinātu apetīti un ortostatisko hipotensiju.
English: This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Latvian: Šis dokuments ir Eiropas Publiskā novērtējuma ziņojuma (EPAR) kopsavilkums par PegIntron.
English: The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Latvian: Pilns PegIntron EPAR teksts ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In adults, the most common side effects with PegIntron (seen in more than 1 patient in 10) are viral infection, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), loss of appetite, depression, anxiety, emotional lability (mood swings), impaired concentration, insomnia (difficulty sleeping), headache, dizziness, dyspnoea (difficulty breathing), cough, vomiting, nausea (feeling sick), abdominal pain (stomach ache), diarrhoea, dry mouth, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection, inflammation at the site of the injection, fatigue (tiredness), asthenia (weakness), irritability, chills, pyrexia (fever), influenza (flu)-like illness and weight loss.
Latvian: Pieaugušajiem visbiežāk novērotās PegIntron blakusparādības (vairāk nekā 1 pacientam no 10) ir vīrusu infekcija, faringīts (rīkles iekaisums), anēmija (mazs sarkano asinsķermenīšu skaits), neitropēnija (mazs balto asinsķermenīšu neitrofilu skaits), ēstgribas zudums, depresija, trauksme, emocionāla labilitāte (pēkšņas garastāvokļa izmaiņas), koncentrēšanās traucējumi, bezmiegs (miega traucējumi), galvassāpes, reibonis, elpas trūkums (apgrūtināta elpošana), klepus, vemšana, slikta dūša, vēdersāpes, caureja, sausa mute, alopēcija (matu izkrišana), nieze, sausa āda, izsitumi, mialģija (muskuļu sāpes), artralģija (sāpes locītavās), sāpes muskuļos un kaulos, reakcijas injekcijas vietā, iekaisums injekcijas vietā, nogurums (nespēks), astēnija (vājums), aizkaitināmība, drebuļi, pireksija (drudzis), gripai līdzīga slimība un ķermeņa masas zudums.
English: PegIntron is also linked to weight loss and reduced growth in children and adolescents.
Latvian: PegIntron ir saistīts arī ar svara zudumu un aizkavētu augšanu bērniem un pusaudžiem.
English: Because PegIntron is linked to side effects such as depression, patients must be closely monitored during treatment.
Latvian: Tā kā PegIntron ir saistīts ar tādām blakusparādībām kā depresija, pacienti ārstēšanas laikā rūpīgi jāuzrauga.
English: The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Latvian: Eiropas Komisija 2000. gada 25. maijā izsniedza PegIntron reģistrācijas apliecību, kas derīga visā Eiropas Savienībā.
English: Other information about PegIntron:
Latvian: Cita informācija par PegIntron
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PegIntron.
Latvian: Tajā ir paskaidrots, kā Cilvēkiem paredzēto zāļu komiteja (CHMP) novērtēja šīs zāles, pirms sniegt pozitīvu atzinumu par reģistrācijas apliecības piešķiršanu un ieteikumus par PegIntron lietošanu.
English: The combination of PegIntron with ribavirin was effective in patients with cirrhosis and in patients infected with HIV.
Latvian: PegIntron kombinācija ar ribavirīnu bija efektīva pacientiem ar cirozi un ar HIV inficētiem pacientiem.
English: Triple therapy led to an increase of about 30% in the number of previously untreated early responders who were cured.
Latvian: Trīskārša terapija par aptuveni 30 % palielināja izārstēšanas biežumu iepriekš neārstētiem pacientiem ar agrīnu atbildes reakciju.
English: Around a quarter of the adults whose previous treatment had failed and around two-thirds of the children and adolescents responded to treatment with PegIntron and ribavirin.
Latvian: Aptuveni ceturtdaļa pieaugušo, kuriem iepriekšējā ārstēšana bijusi neveiksmīga, un aptuveni divas trešdaļas bērnu un pusaudžu reaģēja uz ārstēšanu ar PegIntron un ribavirīnu.
English: PegIntron must not be used in patients with a severe medical condition, severe liver problems, thyroid disease that is not controlled, epilepsy or other central nervous system problems.
Latvian: PegIntron nedrīkst lietot pacienti ar smagām slimībām, smagiem aknu darbības traucējumiem, nekontrolētu vairogdziedzera slimību, epilepsiju vai citiem centrālās nervu sistēmas darbības traucējumiem.
English: PegIntron peginterferon alfa-2b
Latvian: PegIntron peginterferons alfa-2b
English: PegIntron must not be used in people who are hypersensitive (allergic) to any interferon or any of the other ingredients.
Latvian: PegIntron nedrīkst lietot cilvēki ar paaugstinātu jutību (alerģija) pret jebkuru interferonu vai kādu citu šo zāļu sastāvdaļu.
English: The CHMP decided that PegIntron's benefits are greater than its risks and recommended that it be given marketing authorisation.
Latvian: CHMP nolēma, ka pacienta ieguvums, lietojot PegIntron, pārsniedz šo zāļu radīto risku, un ieteica izsniegt PegIntron reģistrācijas apliecību.
English: Why has PegIntron been approved?
Latvian: Kāpēc PegIntron tika apstiprinātas?
English: In adults (aged 18 years and older), PegIntron can be used in patients who have not been treated before or whose previous treatment failed.
Latvian: PegIntron var lietot pieaugušiem pacientiem (no 18 gadu vecuma) , kuri iepriekš nav ārstēti vai kuriem iepriekš veiktā ārstēšana bijusi nesekmīga.
English: The combination of PegIntron and ribavirin has also been studied in one study involving 1,354 adults whose previous treatment had failed and in one study involving 107 children and adolescents aged between three and 17 years who had not been treated before.
Latvian: PegIntron un ribavirīna kombināciju pētīja arī vienā pētījumā, iesaistot 1354 pieaugušos, kuriem iepriekšējā ārstēšana bijusi neveiksmīga, un vienā pētījumā, iesaistot 107 iepriekš neārstētus bērnus un pusaudžus 3-17 gadu vecumā.
English: What benefit has PegIntron shown during the studies?
Latvian: Kādas bija PegIntron priekšrocības šajos pētījumos?
English: The doses of ribavirin and PegIntron may need to be adjusted for patients who experience side effects.
Latvian: Ribavirīna un PegIntron devas, iespējams, jāpielāgo, ja pacientam rodas blakusparādības.
English: For more information about treatment with PegIntron, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Latvian: PegIntron pieejama zāļu lietošanas instrukcijā (kas arī ir daļa no EPAR) vai, sazinoties ar ārstu vai farmaceitu.
English: In children and adolescents receiving PegIntron in combination with ribavirin, side effects were similar to adults, although reduced growth was also seen in more than 1 patient in 10.
Latvian: Bērniem un pusaudžiem, kas saņem PegIntron kombinācijā ar ribavirīnu, nevēlamās blakusparādības bija līdzīgas kā pieaugušajiem, lai gan novēroja arī aizkavētu augšanu vairāk nekā vienam pacientam no desmit.
English: PegIntron can be given in a triple therapy combination with ribavirin and boceprevir to adults with type 1 hepatitis C whose liver is damaged but still able to work normally (compensated liver disease).
Latvian: PegIntron var lietot trīskāršas kombinētas terapijas veidā kopā ar ribavirīnu un bocepreviru pieaugušajiem ar 1. tipa C hepatītu, kuriem aknas ir bojātas, bet aizvien spēj normāli darboties (kompensēta aknu slimība).
English: The interferon alfa-2b in PegIntron is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce interferon alfa-2b.
Latvian: PegIntron sastāvā esošo interferonu alfa-2b iegūst ar paņēmienu, ko sauc par „rekombinantās DNS tehnoloģiju”: to ražo baktērija, kurā ievadīts gēns (DNS), kas nodrošina interferona alfa-2b sintēzi.
English: In other adults with hepatitis C virus in their blood, including patients also infected with human immunodeficiency virus (HIV), PegIntron is given either with ribavirin (dual therapy) or on its own if they cannot take ribavirin.
Latvian: Citiem pieaugušajiem ar C hepatīta vīrusu asinīs, tostarp pacientiem, kas inficēti arī ar cilvēka imūndeficīta vīrusu (HIV), PegIntron lieto kopā ar ribavirīnu (divkārša terapija) vai vienu pašu, ja pacienti nevar lietot ribavirīnu.
English: PegIntron, with or without ribavirin, has been compared with interferon alfa-2b in five main studies involving a total of over 6,000 adults with hepatitis C who had not been treated before, including 328 patients with cirrhosis and 507 patients also infected with HIV.
Latvian: PegIntron iedarbību, lietojot kopā ar ribavirīnu vai bez tā, salīdzināja ar interferonu alfa-2b piecos pamatpētījumos, iesaistot kopumā vairāk nekā 6000 iepriekš neārstētu pieaugušo ar C hepatītu, tostarp 328 pacientus ar cirozi un 507 pacientus, kas inficēti arī ar HIV.
English: PegIntron is a medicine that contains the active substance peginterferon alfa-2b.
Latvian: PegIntron ir zāles, kas satur aktīvo vielu peginterferonu alfa-2b.
English: What is PegIntron?
Latvian: Kas ir PegIntron?
English: In adults, PegIntron was more effective than interferon alfa-2b in patients who had not been treated before, with around a quarter of the patients responding to PegIntron alone and around a half responding to the combination of PegIntron and ribavirin.
Latvian: Pieaugušajiem PegIntron bija efektīvākas par interferonu alfa-2b iepriekš neārstētiem pacientiem; aptuveni ceturtdaļa pacientu reaģēja uz ārstēšanu tikai ar PegIntron un aptuveni puse reaģēja uz PegIntron un ribavirīna kombināciju.
English: What is the risk associated with PegIntron?
Latvian: Kāds risks pastāv, lietojot PegIntron?
English: PegIntron is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Latvian: PegIntron lieto, lai ārstētu pacientus no trīs gadu vecuma ar ilgstošu C hepatītu (aknu slimību, ko izraisa inficēšanās ar C hepatīta vīrusu).
English: There is also a marked increase in cure rates in patients with long-term type 1 hepatitis C when given the triple therapy of PegIntron in combination with ribavirin and boceprevir.
Latvian: Ievērojami palielinās arī izārstēšanas biežums pacientiem ar ilgstošu 1. tipa C hepatītu, lietojot trīskāršu PegIntron terapiju kombinācijā ar ribavirīnu un bocepreviru.
English: In the studies on triple therapy in patients with type 1 hepatitis C and compensated liver disease, PegIntron in combination with ribavirin and boceprevir was shown to be more effective than the dual combination of PegIntron with ribavirin alone.
Latvian: Trīskāršas terapijas pētījumos pacientiem ar 1. tipa C hepatītu un kompensētu aknu slimību pierādīts, ka PegIntron kombinācijā ar ribavirīnu un bocepreviru ir efektīvāks nekā divkārša PegIntron kombinācija tikai ar ribavirīnu.
English: Depending on the severity of the side effects treatment may have to be stopped altogether (including boceprevir).Patients can inject themselves once they have been trained appropriately.
Latvian: Atkarībā no blakusparādību smaguma pakāpes, ārstēšana var būt pilnībā jāpārtrauc (arī ar bocepreviru).
English: Two main studies involving 1,503 adult patients with type 1 hepatitis C and compensated liver disease investigated the effect of PegIntron in a triple therapy combination with ribavirin and boceprevir compared with PegIntron and ribavirin alone.
Latvian: Divos pamatpētījumos, kuros piedalījās 1503 pieauguši pacienti ar 1. tipa C hepatītu un kompensētu aknu slimību, pētīja PegIntron ietekmi trīskāršas terapijas veidā kombinācijā ar ribavirīnu un bocepreviru salīdzinājumā ar gadījumiem, kad PegIntron lietots tikai kombinācijā ar ribavirīnu.
English: Treatment with PegIntron should be started and supervised by a doctor who has experience in the management of patients with hepatitis C. PegIntron is given once a week as an injection under the skin.
Latvian: Ārstēšana ar PegIntron jāsāk un jāuzrauga ārstam ar pieredzi C hepatīta pacientu ārstēšanā.
English: The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Latvian: PegIntron aktīvā viela peginterferons alfa-2b pieder „interferonu” grupai.
English: How does PegIntron work?
Latvian: Kā PegIntron darbojas?
English: For the full list of all side effects reported with PegIntron, see the package leaflet.
Latvian: Pilns visu PegIntron izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas instrukcijā.
English: How is PegIntron used?
Latvian: Kā lieto PegIntron?
English: In PegIntron, the interferon alfa-2b has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Latvian: PegIntron satur interferonu alfa-2b, kas ir „pegilēts" (pārklāts ar ķīmisko vielupolietilēnglikolu).
English: How has PegIntron been studied?
Latvian: Kā noritēja PegIntron izpēte?
English: What is PegIntron used for?
Latvian: Kāpēc lieto PegIntron?
English: The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Tamiflu a Direct Healthcare Professional Communication (DHPC) letter, the text of which is appended to the CHMP assessment report.
Latvian: Dalībvalstīm jānodrošina, ka Reģistrācijas apliecības īpašnieks , visiem ārstiem, kuri varētu ordinēt vai izmantot Tamiflu, piegādās Tieši Veselības Aprūpes Speciālistiem (DHCP - Direct Healthcare Professional Communication) paredzētu vēstuli, kuras teksts ir pievienots CHMP vērtējuma ziņojumam.
English: The Member States shall agree with the MAH the communication plan for the DHPC letter.
Latvian: Dalībvalstij jāvienojas ar Reģistrācijas apliecības īpašnieku par DHCP vēstules izplatīšanas plānu.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
Latvian: Dalībvalstīm jānodrošina, ka visi zemāk aprakstītie nosacījumi vai ierobežojumi attiecībā uz zāļu drošu un efektīvu lietošanu ir ieviesti.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Latvian: PIELIKUMS ZĀĻU DROŠAS UN EFEKTĪVAS LIETOŠANAS NOSACĪJUMI VAI IEROBEŽOJUMI, KAS JĀIEVIEŠ DALĪBVALSTĪS
English: Overall, the safety profile was considered acceptable.
Latvian: Kopumā Takhzyro drošuma profilu uzskatīja par pieņemamu.
English: The doctor may decide that patients or their caregivers can inject the medicine themselves after they have been properly trained.
Latvian: Ārsts var izlemt, vai pacients pats vai viņa aprūpētājs drīkst ievadīt zāles pēc pienācīgas apmācības.
English: As for all medicines, data on the use of Takhzyro are continuously monitored.
Latvian: Tāpat kā par visām zālēm, dati par Takhzyro lietošanu tiek pastāvīgi uzraudzīti.
English: What measures are being taken to ensure the safe and effective use of Takhzyro?
Latvian: Kas tiek darīts, lai garantētu drošu un efektīvu Takhzyro lietošanu?
English: Further information on Takhzyro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Takhzyro.
Latvian: Sīkāka informācija par Takhzyro ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/medicines/human/EPAR/Takhzyro.
English: Other information about Takhzyro
Latvian: Cita informācija par Takhzyro
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3151551
Latvian: Sīkāka informācija par retu slimību ārstēšanai paredzēto zāļu statusa piešķiršanu ir atrodama: ema.europa.eu/medicines/human/orphan-designations/eu3151551
English: The recommended starting dose of Takhzyro is 300 mg every 2 weeks.
Latvian: Ieteicamā Takhzyro sākumdeva ir 300 mg ik pēc divām nedēļām.
English: The European Medicines Agency therefore decided that Takhzyro's benefits are greater than its risks and it can be authorised for use in the EU.
Latvian: Tādēļ Eiropas Zāļu aģentūra nolēma, ka ieguvums, lietojot Takhzyro, pārsniedz šo zāļu radīto risku un zāles var reģistrēt lietošanai ES.
English: Side effects reported with Takhzyro are carefully evaluated and any necessary action taken to protect patients.
Latvian: Ziņotās ar Takhzyro lietošanu saistītās blakusparādības tiek rūpīgi izvērtētas, un tiek veikti visi pacientu aizsardzībai nepieciešamie pasākumi.
English: Patients with angioedema have rapid swelling under the skin in areas such as the face, throat, arms and legs.
Latvian: Pacientiem ar angioedēmu strauji veidojas pietūkums zem ādas tādās vietās kā seja, rīkle, rokas un kājas.
English: If the patient remains free of attacks with the two-weekly dose, the doctor can reduce the frequency to once every 4 weeks.
Latvian: Ja pacientam ar devu ik pēc divām nedēļām lēkmes neatkārtojas, ārsts var samazināt devas biežumu līdz četru nedēļu intervālam.
English: Takhzyro is effective in preventing angioedema attacks and the fact that it only needs to be given every 2 or 4 weeks was considered an advantage over existing treatments.
Latvian: Takhzyro efektīvi novērš angioedēmas lēkmes, un fakts, ka tās jālieto tikai ik pēc divām vai četrām nedēļām, tika uzskatīts par priekšrocību salīdzinājumā ar citām zālēm.