FrancophonIA/ELRC3.0 huggingface dataset:
English: Vectimax 10 mg/Ml Sol. Inj.
Latvian: Vectimax 10 mg/Ml Sol.
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
Latvian: Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 66 days.
Latvian: DZĪVNIEKU PRODUKCIJAS IZMANTOŠANĀ Liellopi: gaļai un blakusproduktiem - 66 dienas.
English: Therefore, the Committee concluded that a harmonised withdrawal period of 49 days could be established for the ivermectin component of all injectable products containing ivermectin, for use in cattle.
Latvian: Tāpēc Komiteja secināja, ka visu injicējamo ivermektīnu saturošo zāļu, ko lieto liellopiem, ivermektīna sastāvdaļai var noteikt saskaņotu 49 dienu izdalīšanās periodu.
English: 4 Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G.
Latvian: 4 Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G. (1993) Effect of formulation on the pharmacokinetics and efficacy of doramectin.
English: Invesa International S.A. Esmeralda 19
Latvian: Invesa International S.A.
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients:
Latvian: A. I pielikumā minētajām zālēm, kas kā aktīvās vielas satur ivermektīnu un klorsulonu:
English: Paramectin Injectável 1%
Latvian: Paramectin Inje ctável 1%
English: Belgium Laboratorios Calier SA Barcelones
Latvian: Nīderlande Laboratorios Calier SA Barcelones
English: Closiver Injection Ivermectin 5 mg/ml, Closantel 125 mg/ml
Latvian: Closiver Injection Ivermektīns 5 mg/ml, klosantels 125 mg/ml
English: The Netherlands Dopharma Research B.V. Zalmweg 24
Latvian: Nīderlande Dopharma Research B.V.
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days.
Latvian: DZĪVNIEKU PRODUKCIJAS IZMANTOŠANĀ Liellopi: gaļai un blakusproduktiem - 49 dienas.
English: 2.2 Derivation of the withdrawal period for injectable veterinary medicinal products contains ivermectin as well as a second active substance (combination products)
Latvian: Izdalīšanās perioda aprēķins injicējamām veterinārām zālēm, kas satur ivermektīnu un otru aktīvo vielu (kombinētiem preparātiem)
English: Cattle, Sheep, Goats, Pigs
Latvian: Liellopi, aitas, kazas, cūkas
English: INTERVET ROMANIA S.R.L.
Latvian: Rumānija INTERVET ROMANIA S.R.L. Şoseaua de Centură, nr.
English: Ivermectin 5 mg/ml, Closantel 125 mg/ml
Latvian: Ivermektīns 5 mg/ml, klosantels 125 mg/ml
English: bovine and porcine
Latvian: Liellopi, cūkas
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 4.11 Withdrawal period(s)
Latvian: A. I pielikumā minētajām zālēm, kas kā aktīvās vielas satur ivermektīnu un klorsulonu: 10. IEROBEŽOJUMU PERIODS(I)
English: The Netherlands Chanelle Animal Health Ltd 7 Rodney Street
Latvian: Nīderlande Chanelle Animal Health Ltd 7 Rodney Street
English: Gerbičeva 50, 1000 Ljubljana Slovenia
Latvian: 1000 Ljubljana
English: DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.
Latvian: Rumānija DAR AL DAWA VETERINARY & AGRICULTURAL
English: The Netherlands VIRBAC DE PORTUGAL Laboratorios Lda
Latvian: Nīderlande VIRBAC DE PORTUGAL Laboratorios Lda
English: Figure 1.
Latvian: 1. att.
English: Czech Republic Vétoquinol s.r.o., Zámečnícka 411,
Latvian: Vétoquinol s.r.o., Zámečnícka 411, 288 02 Nymburk, Czech Republic
English: The Netherlands Merial B.V. Kleermakerstraat 10
Latvian: Kleermakerstraat 10
English: Baymec Trio 1% Ivermectin 10 mg/ml
Latvian: Baymec Trio 1% Ivermektīns 10 mg/ml
English: VMD Animal Health Ltd. Közraktár u. 22/b.
Latvian: VMD Animal Health Ltd.
English: United Kingdom Chanelle Animal Health Ltd 7 Rodney Street
Latvian: Portugāle Chanelle Animal Health Ltd 7 Rodney Street
English: Ivermectin
Latvian: Ivermektīns
English: Belgium VIRBAC DE PORTUGAL Laboratorios Lda
Latvian: Norvēģija VIRBAC DE PORTUGAL Laboratorios Lda
English: BOVIMEC B Ivermectin 10 mg/ml
Latvian: BOVIMEC B Ivermektīns 10 mg/ml
English: Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Latvian: Slovēnija MERIAL 29 avenue Tony Garnier 69007 LYON France
English: Fat
Latvian: Stiprums
English: Introduction
Latvian: Lietošanas
English: The Netherlands Cross Vetpharm Group Ltd, Broomhill Road
Latvian: Nīderlande Cross Vetpharm Group Ltd, Broomhill Road
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Latvian: IZMAIŅAS, KAS VEICAMAS ATBILSTOŠOS ZĀĻU APRAKSTA APAKŠPUNKTOS
English: Wedemec R Ivermectin 10 mg/ml
Latvian: Wedemec R Ivermektīns 10 mg/ml
English: Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Latvian: Rumānija MERIAL 29 avenue Tony Garnier 69007 LYON France
English: IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE
Latvian: IVERMECTINE ECO 10 MG/ML SOLUTION INJECTABLE
English: Subcutaneous Cattle, Sheep, Goats: 200 μg ivermectin/kg bw
Latvian: Zemādas Liellopi, aitas, kazas: 200 μg ivermektīna uz 1 kg ķermeņa svara
English: MAXIMEC Ivermectin 10 mg/ml
Latvian: MAXIMEC Ivermektīns 10 mg/ml
English: United Kingdom VIRBAC DE PORTUGAL Laboratorios Lda
Latvian: Portugāle VIRBAC DE PORTUGAL Laboratorios Lda
English: 1070 Bruxelles
Latvian: 04011 Aprilia
English: Cattle, Reindeer, Pigs
Latvian: Liellopi, ziemeļbrieži, cūkas
English: FROMMECTIN Ivermectin 10 mg/ml
Latvian: FROMMECTIN Ivermektīns 10 mg/ml
English: Maximec Injectie Ivermectin 10 mg/ml
Latvian: Maximec Injectie Ivermektīns 10 mg/ml
English: Paramectin 1% Ivermectin 10 mg/ml
Latvian: Paramectin 1% Ivermektīns 10 mg/ml
English: Euromec Injectie Ivermectin 10 mg/ml
Latvian: Euromec Injectie Ivermektīns 10 mg/ml
English: The Netherlands ECO Animal Health Ltd 78 Coombe Road
Latvian: Nīderlande ECO Animal Health Ltd 78 Coombe Road
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill Road
Latvian: Portugāle Cross Vetpharm Group Ltd, Broomhill Road
English: Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Latvian: Ivermektīns 10 mg/ml, klorsulons 100 mg/ml
English: IVERTIN Ivermectin 10 mg/ml
Latvian: IVERTIN Ivermektīns 10 mg/ml
English: ECOMECTIN Ivermectin 10 mg/ml
Latvian: ECOMECTIN Ivermektīns 10 mg/ml
English: VETERMEC Ivermectin 10 mg/ml
Latvian: VETERMEC Ivermektīns 10 mg/ml
English: IVOMEC D Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Latvian: IVOMEC D Ivermektīns 10 mg/ml, klorsulons 100 mg/ml
English: Enovex Injection Ivermectin 10 mg/ml
Latvian: Enovex Injection Ivermektīns 10 mg/ml
English: The Netherlands Norbrook Laboratories Limited Station Works
Latvian: Nīderlande Norbrook Laboratories Limited Station Works
English: Biomectin 1 % Ivermectin 10 mg/ml
Latvian: Biomectin 1% Ivermektīns 10 mg/ml
English: Biomectin 1% Ivermectin 10 mg/ml
Latvian: Biomectin 1 % Ivermektīns 10 mg/ml
English: IVOMEC F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Latvian: IVOMEC F Ivermektīns 10 mg/ml, klorsulons 100 mg/ml
English: Bimectin Injectie Ivermectin 10 mg/ml
Latvian: Bimectin Injectie Ivermektīns 10 mg/ml
English: BIMECTIN Ivermectin 10 mg/ml
Latvian: BIMECTIN Ivermektīns 10 mg/ml
English: Ivomec 1% Ivermectin 10 mg/ml
Latvian: Ivomec 1% Ivermektīns 10 mg/ml
English: Ecomectin 1% Ivermectin 10 mg/ml
Latvian: Ecomectin 1% Ivermektīns 10 mg/ml
English: Pandex 1 % Ivermectin 10 mg/ml
Latvian: Pandex 1% Ivermektīns 10 mg/ml
English: Pandex 1% Ivermectin 10 mg/ml
Latvian: Pandex 1 % Ivermektīns 10 mg/ml
English: VALANEQ Ivermectin 10 mg/ml
Latvian: VALANEQ Ivermektīns 10 mg/ml
English: Anisec Injection Ivermectin 10 mg/ml
Latvian: Anisec Injection Ivermektīns 10 mg/ml
English: Alfamec 1 % Ivermectin 10 mg/ml
Latvian: Alfamec 1 % Ivermektīns 10 mg/ml
English: TIZOVAL Ivermectin 10 mg/ml
Latvian: TIZOVAL Ivermektīns 10 mg/ml
English: Cevamec 1% Ivermectin 10 mg/ml
Latvian: Cevamec 1% Ivermektīns 10 mg/ml
English: Belgium Norbrook Laboratories Limited Station Works
Latvian: Norvēģija Norbrook Laboratories Limited Station Works
English: Animec Injection Ivermectin 10 mg/ml
Latvian: Animec Injection Ivermektīns 10 mg/ml
English: Ivotan LA Ivermectin 10 mg/ml
Latvian: Ivotan LA Ivermektīns 10 mg/ml
English: Ivermectina 1% Ivermectin 10 mg/ml
Latvian: Ivermectina 1% Ivermektīns 10 mg/ml
English: Topimec Injection Ivermectin 10 mg/ml
Latvian: Topimec Injection Ivermektīns 10 mg/ml
English: ANTIBIOTICE IASI S.A. Str. Valea Lupului, nr. 1, Iaşi, jud.
Latvian: 1, Iaşi, jud.
English: Belgium ECO Animal Health Ltd 78 Coombe Road
Latvian: Bulgārija ECO Animal Health Ltd 78 Coombe Road
English: Virbamec F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Latvian: Virbamec F Ivermektīns 10 mg/ml, klorsulons 100 mg/ml
English: BOVECTIN Ivermectin 10 mg/ml
Latvian: IVERTIN BOVIN Ivermektīns 10 mg/ml
English: IVERVETo 1 % Ivermectin 10 mg/ml
Latvian: Iverveto 1% Ivermektīns 10 mg/ml
English: Iverveto 1% Ivermectin 10 mg/ml
Latvian: IVERVETo 1 % Ivermektīns 10 mg/ml
English: Belgium MERIAL Belgium S.A. Bld Sylvain Dupuis 243
Latvian: MERIAL Belgium S.A.
English: United Kingdom Norbrook Laboratories Limited Station Works
Latvian: Portugāle Norbrook Laboratories Limited Station Works
English: PROMECTINE Ivermectin 10 mg/ml
Latvian: PROMECTINE Ivermektīns 10 mg/ml
English: Iverktin Injection Ivermectin 10 mg/ml
Latvian: Iverktin Injection Ivermektīns 10 mg/ml
English: Czech Republic ECO Animal Health Ltd 78 Coombe Road
Latvian: Rumānija ECO Animal Health Ltd 78 Coombe Road
English: Aniject Injection Ivermectin 10 mg/ml
Latvian: Aniject Injection Ivermektīns 10 mg/ml
English: Ivodad 1% Ivermectin 10 mg/ml
Latvian: Ivodad 1% Ivermektīns 10 mg/ml
English: Cattle, pigs Subcutaneous Cattle: 200 μg ivermectin/kg bw
Latvian: Zemādas Liellopi, ziemeļbrieži: 200 μg ivermektīna uz 1 kg ķermeņa svara
English: Sumiject Injection Ivermectin 10 mg/ml
Latvian: Medimec Injection Ivermektīns 10 mg/ml
English: WITHDRAWAL PERIOD
Latvian: 10. IEROBEŽOJUMU PERIODS(I)
English: This especially affects fast-growing cells such as cancer cells.
Latvian: Tas jo īpaši ietekmē ātri augošas šūnas, piemēram, vēža šūnas.
English: What measures are being taken to ensure the safe and effective use of Jylamvo?
Latvian: Kas tiek darīts, lai garantētu drošu un efektīvu Jylamvo lietošanu?
English: Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo.
Latvian: Sīkāka informācija par Jylamvo ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/medicines/human/EPAR/jylamvo.
English: Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017.
Latvian: 2017. gada 29. martā Jylamvo reģistrācijas apliecību, kas derīga visā ES.
English: It must not be used if the patient is breastfeeding or is receiving live vaccines.
Latvian: Tās nedrīkst lietot, ja paciente baro bērnu ar krūti vai saņem dzīvas vakcīnas.
English: The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week.
Latvian: Ārsts var ar pacienta vai pacienta aprūpētāja palīdzību pārbaudīt, vai var droši lietot zāles reizi nedēļā.
English: In most cases, methotrexate medicines are used for long-term treatment.
Latvian: Vairumā gadījumu metotreksātu saturošas zāles tiek lietotas ilgstošai ārstēšanai.
English: For inflammatory conditions it is taken once a week, on the same day each week.
Latvian: Iekaisuma slimību ārstēšanai šīs zāles lieto vienreiz nedēļā vienā un tajā pašā nedēļas dienā.
English: What is Jylamvo and what is it used for?
Latvian: Kas ir Jylamvo un kāpēc tās lieto?
English: As for all medicines, data on the use of Jylamvo are continuously monitored.
Latvian: Tāpat kā par visām zālēm dati par Jylamvo lietošanu tiek pastāvīgi uzraudzīti.
English: How often methotrexate is given depends on the other medicines it is used with.
Latvian: Metotreksāta lietošanas biežums ir atkarīgs no citām zālēm, ar ko kopā to lieto.
English: The company will also send out follow-up questionnaires for dosing errors that result in overdose.
Latvian: Uzņēmums arī nosūtīs atbildes uz anketas jautājumiem par dozēšanas kļūdām, kas izraisa pārdozēšanu.
English: The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.
Latvian: Uzņēmums sniedza datus no publicētās literatūras par metotreksāta ieguvumiem un riskiem attiecībā uz apstiprinātajiem lietošanas veidiem.
English: Side effects reported with Jylamvo are carefully evaluated and any necessary action taken to protect patients.
Latvian: Ziņotās ar Jylamvo lietošanu saistītās blakusparādības tiek rūpīgi izvērtētas, un tiek veikti visi pacientu aizsardzībai nepieciešamie pasākumi.
English: An overview of Jylamvo and why it is authorised in the EU
Latvian: Jylamvo pārskats un kāpēc tās ir reģistrētas ES
English: Why is Jylamvo authorised in the EU?
Latvian: Kāpēc Jylamvo ir reģistrētas ES?
English: The company that markets Jylamvo will supply a guide for healthcare professionals and a patient alert card, on how to use the medicine correctly and how to avoid medication errors.
Latvian: Uzņēmums, kas piedāvā tirgū Jylamvo, izsniegs rokasgrāmatu veselības aprūpes speciālistiem un pacienta brīdinājuma karti par to, kā pareizi lietot šīs zāles un kā izvairīties no zāļu lietošanas kļūdām.
English: Jylamvo (methotrexate)
Latvian: Jylamvo (metotreksāts)
English: As for every medicine, the company provided studies on the quality of Jylamvo.
Latvian: Kā visām zālēm, uzņēmums nodrošināja pētījumus par Jylamvo kvalitāti.
English: The way methotrexate works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system.
Latvian: Vēl nav pilnībā izprasts, kā metotreksāts darbojas pacientiem ar artrītu un psoriāzi, bet metotreksāta lietošanas ieguvumi, domājams, ir saistīti ar tā spēju mazināt iekaisumu un nomākt pārmērīgi aktīvo imūnsistēmas darbību.
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Latvian: Tās drīkst izrakstīt tikai ārsti ar pieredzi metotreksāta lietošanā un pilnīgu izpratni par risku, kas saistīts ar ārstēšanu, lietojot metotreksātu.
English: The dose that the patient takes each week depends on which inflammatory condition it is being used for, how well the treatment is working and, in the case of children, on the child's height and weight.
Latvian: Katru nedēļu injicētā deva ir atkarīga no tā, kādas slimības ārstēšanai zāles tiek izmantotas un cik labi šī ārstēšana iedarbojas, un bērniem tā ir arī atkarīga no bērna auguma un masas.
English: Other information about Jylamvo
Latvian: Cita informācija par Jylamvo
English: The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat.
Latvian: Eiropas Zāļu aģentūra nolēma, ka Jylamvo ir līdzvērtīga kvalitāte un tās ir bioekvivalentas metotreksātu saturošām zālēm Methotrexat Lederle un Ebetrexat.
English: The company also carried out studies that showed that it is bioequivalent to other methotrexate medicines used to treat inflammatory conditions and ALL (Methotrexat Lederle and Ebetrexat tablets).
Latvian: Uzņēmums arī veica pētījumus, kuros tika pierādīts, ka šīs zāles ir “bioekvivalentas” citām metotreksātu saturošām zālēm, ko lieto iekaisuma slimību un ALL ārstēšanai (Methotrexat Lederle un Ebetrexat tabletes).
English: Jylamvo is available as a liquid to be taken by mouth and it can only be obtained with a prescription.
Latvian: Jylamvo ir pieejamas kā šķīdums iekšķīgai lietošanai, un tās var iegādāties tikai pret recepti.
English: For acute lymphoblastic leukaemia, the dose of Jylamvo depends on the patient's height and weight.
Latvian: Akūtas limfoblastiskas leikēmijas gadījumā Jylamvo deva ir atkarīga no pacienta auguma un masas.
English: What benefits of Jylamvo have been shown in studies?
Latvian: Kādi Jylamvo ieguvumi atklāti pētījumos?
English: Jylamo must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system.
Latvian: Jylamvo nedrīkst lietot pacientiem, kuri pārmērīgi lieto alkoholu, vai tiem, kuriem ir aknu vai smagu nieru darbības traucējumi, asins slimības, novājināta imūnsistēma (organisma aizsargsistēma), smagas vai ilgstošas infekcijas, piemēram, tuberkuloze un HIV infekcija, mutes čūlas, iekaisums mutē un čūlas gremošanas sistēmā.
English: For more information about using Jylamvo, see the package leaflet or contact your doctor or pharmacist.
Latvian: Papildu informāciju par Jylamvo lietošanu skatīt zāļu lietošanas instrukcijā vai jautāt ārstam vai farmaceitam.
English: The most common side effects with Jylamvo (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver.
Latvian: Visbiežākās Jylamvo blakusparādības (kas var rasties vairāk nekā 1 no 10 cilvēkiem) ir ietekme uz gremošanas sistēmu (piemēram, mutes gļotādas iekaisums, gremošanas traucējumi, sāpes vēderā, slikta dūša un ēstgribas zudums), kā arī asins analīžu rezultāti, kuros redzamas pārmaiņas aknās.
English: The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA.
Latvian: Jylamvo aktīvā viela metotreksāts aptur šūnu augšanu, kavējot DNS sintēzi.
English: The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU.
Latvian: Tādēļ aģentūra nolēma, ka ieguvums, lietojot Jylamvo, pārsniedz šo zāļu radīto risku un zāles var reģistrēt lietošanai ES.
English: Jylamvo is a ‘hybrid medicine'.
Latvian: Jylamvo ir “hibrīdzāles”.
English: The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions.
Latvian: Visbiežākās smagās blakusparādības ir asins šūnu ražošanas samazināšanās, plaušu, aknu, nieru un nervu bojājumi, trombembolija (problēmas saistībā ar trombiem asinsvados), kā arī smagas alerģiskas reakcijas un ādas reakcijas.
English: Jylamvo contains the active substance methotrexate.
Latvian: Jylamvo satur aktīvo vielu metotreksātu.
English: • acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.
Latvian: • akūta limfoblastiska leikēmija (ALL) (balto asinsšūnu vēzis) pieaugušiem pacientiem un bērniem vecumā no 3 gadu vecuma.
English: The reference medicine for Jylamvo is Methotrexat Lederle injection.
Latvian: Jylamvo atsauces zāles ir Methotrexat Lederle injekcija.
English: Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions:
Latvian: Jylamvo ir pretiekaisuma un pretvēža zāles, ko lieto šādu slimību ārstēšanai:
English: • active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
Latvian: • aktīvs reimatoīdais artrīts (slimība, kas izraisa locītavu iekaisumu) pieaugušiem pacientiem;
English: How does Jylamvo work?
Latvian: Kā Jylamvo darbojas?
English: • severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
Latvian: • smags psoriātiskais artrīts (locītavu iekaisums, kas rodas pacientiem ar psoriāzi) pieaugušiem pacientiem;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jylamvo have also been included in the summary of product characteristics and the package leaflet.
Latvian: Turklāt zāļu aprakstā un lietošanas instrukcijā tika ietverti arī ieteikumi un piesardzības pasākumi, kas jāievēro veselības aprūpes speciālistiem un pacientiem, lai garantētu drošu un efektīvu Jylamvo lietošanu.
English: For the full list of side effects and restrictions of Jylamvo, see the package leaflet.
Latvian: Pilnu visu Jylamvo blakusparādību un ierobežojumu sarakstu skatīt zāļu lietošanas instrukcijā.
English: How is Jylamvo used?
Latvian: Kā lieto Jylamvo?
English: What are the risks associated with Jylamvo?
Latvian: Kāds risks pastāv, lietojot Jylamvo?
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Jylamvo is given in a different way.
Latvian: “atsauces zālēm vielu, bet Jylamvo tiek lietotas citā veidā.
English: • severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Latvian: • smags juvenils idiopātiskais artrīts (locītavu iekaisums bērniem) pacientiem no trīs gadu vecuma,
English: • severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;
Latvian: • smaga, invaliditāti izraisoša psoriāze (slimība, kas izraisa sarkanus, zvīņainus plankumus uz ādas)
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Latvian: reģistrācijas apliecības īpašniekam jāiesniedz šo zāļu periodiski atjaunojamie drošuma ziņojumi atbilstoši Eiropas Savienības atsauces datumu un periodisko ziņojumu iesniegšanas biežuma sarakstam (EURD sarakstam), kas sagatavots saskaņā ar Direktīvas 2001/83/EK 107.c panta 7. punktu un publicēts Eiropas Zāļu aģentūras tīmekļa vietnē.
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Latvian: Dalībvalsts(-u) vai atsauces dalībvalsts(-u), ja piemērojams, valstu kompetentajām iestādēm jānodrošina, lai reģistrācijas apliecības īpašnieks(-i) izpildītu šādus nosacījumus:
English: Annex IV Condition to the marketing authorisations
Latvian: IV pielikums
English: HbA1c, % Not applicable
Latvian: HbA1c, % Nav piemērojams
English: The study is to be monitored regularly by a Data Monitoring Committee (DMC).
Latvian: Pētījums regulāri jāuzrauga Datu uzraudzības komitejai (DUK).
English: You should talk to your doctor, especially if:
Latvian: Jums jākonsultējas ar savu ārstu, īpaši ja:
English: Submission of the protocol by 31 March
Latvian: Protokola iesniegšana līdz 2015. gada 31. martam.
English: The dose will be gradually adapted as follows:
Latvian: Deva tiks pakāpeniski pielāgota šādi:
English: Suicide and suicidal behaviour
Latvian: Pašnāvība un pašnāvnieciska uzvedība
English: Someone who has had a fit may be confused afterwards and may not remember what has happened.
Latvian: Daži cilvēki, kuriem bijusi krampju lēkme, pēc tam var būt apjukuši un var neatcerēties, kas noticis.
English: General supportive and symptomatic measures are also recommended.
Latvian: Ieteicami arī vispārēji atbalstoši un simptomātiskās ārstēšanas pasākumi.
English: The need for continued treatment should be evaluated after 16 weeks (see section 4.1) and reevaluated annually.
Latvian: Nepieciešamība turpināt ārstēšanu jāvērtē pēc 16 nedēļām (skatīt 4.1. apakšpunktu) un jāpārvērtē katru gadu.
English: OCT2 substrates
Latvian: OCT2 substrāti
English: Results are based on last-observation-carriedforward (LOCF).
Latvian: Rezultāti pamatojas uz pārcelto uz priekšu pēdējo novērojumu (LOCF).
English: Do not delay, contact your doctor or your nearest hospital emergency department immediately.
Latvian: Nevilcinieties, nekavējoties sazinieties ar ārstu vai tuvākās slimnīcas neatliekamās palīdzības nodaļu.
English: 56-Week Data
Latvian: 56. nedēļas dati
English: If you do drink a lot now, do not just stop suddenly, because that may put you at risk of having a fit.
Latvian: Ja Jūs tagad lietojat daudz alkohola, nepārtrauciet pēkšņi, jo tas Jums var radīt krampju attīstības risku.
English: 28-Week Data
Latvian: 28. nedēļas dati