natgillin/translations-raw huggingface dataset:
• the CVMP considered that sources of variation linked to the subcutaneous use of ivermectin in cattle are present that lead to different depletion profiles in residue studies, and this variation is of much more importance than any variation that may be caused by formulation differences. 
• veterinaarravimite komitee leidis, et veistel kasutamiseks ette nähtud ivermektiini subkutaanse kasutamisega seoses esineb varieeruvuse allikaid, mis viivad erinevate jääkide kadumise profiilideni jääkidealastes uuringutes, ning kõnealune varieeruvus on palju olulisem kui erineva ravimvormi põhjustatud mis tahes võimalik varieeruvus; kõnealused erinevused tekivad ilmselt ka praktikas;
Since the withdrawal period calculated based on the clorsulon component for these product exceeds the 49 days derived for the ivermectin component, 66 days is recommended as the withdrawal period for the combination products containing ivermectin and clorsulon. 
Et nendel ravimitel ületab klorsuloonikomponendi puhul väljaarvutatud keeluaeg 49 päeva, mis määrati keeluajaks ivermektiini komponendi puhul, soovitatakse klorsulooni ja ivermektiini sisaldavate kombinatsioonravimite keeluajaks 66 päeva.
Ganzestaartsedijk 8 - 5525 KC Duizel 
Rumeenia PANTEX Ganzestaartsedijk 8 - 5525 KC Duizel The Netherlands
100 μg/kg 100 μg/kg 
100 µg/kg 100 µg/kg
The withdrawal period for the product will be the longer of the withdrawal periods derived for the individual components. 
Ravimi keeluajaks on üksikkomponentidele määratud keeluaegade hulgast pikim.
Marker residue Animal species MRLs 
Markerjääk Loomaliigid Jääkide piirnormid
Slovak Republic Pharmagal spol.s.r.o. 
Pharmagal spol.s.r.o.
Moreover, because of the fact that the variation in the residue profile due to sources of variation connected to the subcutaneous use of ivermectin is much greater than the formulation effect, the Committee concluded that it would be appropriate to consider the totality of ivermectin residue data from all formulation groups to derive a single harmonised withdrawal period. 
Lisaks jõudis veterinaarravimite komitee seisukohale, et kuna ivermektiini subkutaanse kasutamisega seotud varieeruvuse allikatest tingitud jääkide kadumise profiilide erinevus on palju suurem kui ravimvormi mõju, siis oleks asjakohane kaaluda kõigi ravimvormi rühmade ivermektiini jääkidega seotud andmeid ning määrata ühtne keeluaeg.
3440 AB Woerden, The Netherlands 
3440 AB Woerden,
Czech Republic Bremer Pharma GmbH Cherbourger Str. 25 
Rumeenia Bremer Pharma GmbH Cherbourger Str. 25
If, on the other hand, the withdrawal period determined on the basis of residue depletion data for the second active substance is greater than 49 days, then the recommended withdrawal period for the product should be based on depletion of residues of the second active substance. 
Kui aga jääkide kadumise andmete alusel leitud teise toimeaine keeluaeg on pikem kui 49 päeva, peab ravimi soovitatav keeluaeg lähtuma teise toimeaine jääkide kadumisest.
The harmonised withdrawal period of 49 days is relevant only to the ivermectin component of injectable products containing ivermectin. 
Kooskõlastatud 49-päevane keeluaeg kehtib ivermektiini sisaldavate süsteravimite puhul ainult ivermektiinikomponendile.
AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 
Merial Portuguesa - Saúde Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro Portugal
22,23-Dihydroavermectin B1a 
Ivermektiin dihüdroavermek tiin B1a
ANNEX III AMENDMENT TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 
III LISA RAVIMI OMADUSTE KOKKUVÕTTE, PAKENDI MÄRGISTUSE JA PAKENDI INFOLEHE MUUDATUSED
Other sources of variation connected to the subcutaneous use of ivermectin were therefore considered to be of more importance than formulation with regard to residue depletion and withdrawal periods. 
Invermektiini subkutaanse kasutamisega seotud muid varieeruvuse allikaid hinnati seetõttu jääkide kadumise ja keeluajaga seoses olulisemaks kui ravimvormi.
If the withdrawal period determined on the basis of residue depletion data for the second active substance is less than 49 days, then a withdrawal period of 49 days is recommended for the product. 
Kui jääkide kadumise andmete alusel leitud teise toimeaine keeluaeg on lühem kui 49 päeva, soovitatakse ravimile kehtestada keeluaeg pikkusega 49 päeva.
For injectable veterinary medicinal products containing ivermectin in combination with another active substance residue depletion of the second active substance must also be considered, and a withdrawal period for the second active substance derived. 
Süstitavate veterinaarravimite puhul, mis sisaldavad ivermektiini kombinatsioonis teise toimeainega, tuleb arvestada ka teise toimeaine jääkide kadumisega ja määrata seega teise toimeaine keeluaeg.
Ivermectin was previously evaluated by the CVMP in order to establish maximum residue limits (MRLs). 
Veterinaarravimite komitee hindas ivermektiini, et teha kindlaks ravimijääkide piirnormid.
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 10. 
A. I lisas loetletud ravimitele, mis sisaldavad toimeainetena ivermektiini ja klorsulooni: 10.
• the CVMP considered that for combination products containing ivermectin as well as a second active substance, residue depletion of the second active substance must also be considered when setting the withdrawal period and the withdrawal period for the product shall be the longest established for the individual components. 
• veterinaarravimite komitee leidis, et ivermektiini ja ka teist toimeainet sisaldavate ravimite puhul tuleb keeluaja määramisel arvestada ka teise toimeaine jääkide kadumisega ning ravimi keeluajaks määrata pikim keeluaeg üksikkomponentide keeluaegade hulgast;
B. For products listed in Annex I containing ivermectin as sole active ingredient or in combination with closantel: 
B. I lisas loetletud ravimitele, mis sisaldavad ivermektiini ainsa toimeainena või kombinatsioonis klosanteeliga:
Residue depletion data submitted for the formulation group containing ivermectin and closantel led to a withdrawal period of 36 days for closantel, calculated using the alternative approach and applying a safety span of 30%. 
Ivermektiini ja klosanteeli sisaldava ravimvormide rühma kohta esitatud jääkide kadumise andmete alusel leiti (alternatiivne lähenemine ja 30%-line ohutusvahemik), et klosanteeli keeluaeg on 36 päeva.
IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE 
IVERMEKTIINE ECO 10 MG/ML SOLUTION I NJECTABLE
Paramectin Multi Injection 1% w/v Solution for Injection for Cattle, Sheep and Pigs 
Paramectin Multi Injection 1% w/v Solution for Injection for Veised, Lambad and Sead
BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria 
Bulgaaria BIOVET JSC 39 Petar Rakov Str.
Since this is below the 49 days limit applied for the ivermectin component, a withdrawal period of 49 days is recommended for the combination products containing ivermectin and closantel. 
Et see on lühem kui ivermektiinikomponendi puhul kehtiv 49-päevane periood, soovitatakse ivermektiini ja klosanteeli sisaldavate kombinatsioonravimite keeluajaks 49 päeva
DUTCH FARM VETERINARY PHARMACEUTICALS B.V. 
Rumeenia DUTCH FARM VETERINARY PHARMACEUTICALS
Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 - 335 Sintra Portugal 
Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro
Closiver Injection Ivermectin 5 mg/ml, Closantel 125 mg/ml 
Closiver Injection Ivermektiin 5 mg/ml, Klosanteel 125 mg/ml
A safety span of 30% was used in view of the large variation in the intake figures, which was primarily caused by the variation of residues found in injection sites. 
Arvestades tarbitud koguste näitajate suurt varieeruvust, mille tingis eeskätt süstekohtades leitud jääkide varieeruvus, kasutati 30%-list ohutusvahemikku.
United Kingdom Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland 
Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
Ivomec Classic Injection for Cattle and Sheep 1% w/v 
Ivomec Classic Injection for Veised and Lambad 1% w/v
Pharmacologically active substance 
Farmakoloogiline toimeaine
Sant Hipolit, km 71 08503 - Gurb-Vic Barcelona 
08503 - Gurb-Vic
A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 
A. I lisas loetletud ravimitele, mis sisaldavad toimeainetena ivermektiini ja klorsulooni:
In these studies, different formulations showed different absorption patterns of avermectins (including ivermectin), while all other parameters were the same (such as species, breed, weight, and place of injection). 
Kõnealustes uuringutes ilmnes erinevate ravimvormide puhul ja kõigi muude parameetrite (loomaliik, tõug, kehamass, süstekoht) samaks jäämisel avermektiinide (sealhulgas ivermektiin) imendumiskiiruste erinevus.
Cattle: Meat and offal - 66 days. 
Veised: liha ja söödav rups - 66 päeva.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING 
PAKENDI MÄRGISTUSE ASJAKOHASTESSE LÕIKUDESSE TEHTAVAD MUUDATUSED
Discussion of specific issues raised in the referral notification 
Esildises tõstatatud konkreetsete küsimuste arutelu
Cattle, Sheep, Goats, Pigs 
Veised, lambad, kitsed, sead
Interchemie werken “de Adelaar” BV 
Interchemie werken “de Adelaar” BV Horsterweg 26A
Sumex Injection for Cattle, 1%, Solution for injection for cattle 
Sumex Injection for Veised, 1%, Solution for injection for veised
Animal species 
Tugevus Loomaliigid Manustamisviis
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland 
Loughrea, Co. Galway, Ireland
Ivermectin 5 mg/ml, Closantel 125 mg/ml 
Ivermektiin 5 mg/ml, Klosanteel 125 mg/ml
4.11 Withdrawal period(s) Cattle: Meat and offal - 49 days. 
4.11 Keeluaeg (-ajad) Veised: liha ja söödav rups - 49 päeva.
Ivomec Classic Injection for Cattle and Sheep 
Ivomec Classic Injection for Veised and Lambad
Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), 
Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road
Paramectin Injectie 
Paramectin Injectável
Gerbičeva 50, 1000 Ljubljana Slovenia 
1000 Ljubljana
Individual withdrawal periods (days) derived from the ivermectin residue studies 
Ivermektiini jääkide kadumise uuringute alusel arvutatud individuaalsed keeluajad (päevades)
Virbamec Injectable Solution For Cattle and Swine 
Virbamec Injectable Solution For Veised and Swine
Maximec Injection for Cattle & Sheep 
Maximec Injection for Veised & Lambad
WITHDRAWAL PERIOD Cattle: Meat and offal - 66 days. 
KEELUAEG Veised: liha ja söödav rups - 66 päeva.
The Netherlands Merial B.V. Kleermakerstraat 10 
Kleermakerstraat 10
Panomec 1% Solution for Injection for Cattle, Sheep and Pigs 
Panomec 1% Solution for Injection for Veised, Lambad and Sead
WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days 
KEELUAEG Veised: liha ja söödav rups - 49 päeva
Bovimec 1.0% w/v Solution for Injection for Cattle 
Bovimec 1.0% w/v Solution for Injection for Veised
Centrovet Ltd. 
Alstoe Ltd
Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght 
Bimeda (a division of Cross Vetpharm Group Limited)
Based on the 11 ivermectin residue depletion studies of adequate quality provided, the CVMP calculated the withdrawal periods for 12 products. 
Veterinaarravimite komitee arvutas keeluaja 12 toote puhul, toetudes esitatud 11-le piisava kvaliteediga ivermektiini jääkide kadumise uuringule.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET 
PAKENDI INFOLEHE ASJAKOHASTESSE LÕIKUDESSE TEHTAVAD MUUDATUSED
DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. 
Rumeenia DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. Jordan NA UR 11710 PO BOX 285 Jordania
Cattle, Reindeer, Pigs 
Veised, põhjapõdrad, sead
MERIAL GmbH Am Söldnermoos 6 D-85399 Hallbergmoos Germany 
D-85399 Hallbergmoos Germany
Baymec Trio 1% Ivermectin 10 mg/ml 
Baymec Trio 1% Ivermektiin 10 mg/ml
Czech Republic Vétoquinol s.r.o., Zámečnícka 411, 
Vétoquinol s.r.o., Zámečnícka 411, 288 02 Nymburk, Czech Republic
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS 
RAVIMI OMADUSTE KOKKUVÕTTE ASJAKOHASTESSE LÕIKUDESSE TEHTAVAD MUUDATUSED
United Kingdom VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1, 
Saksamaa VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1,
BOVIMEC B Ivermectin 10 mg/ml 
BOVIMEC B Ivermektiin 10 mg/ml
The numbering of the formulation groups is arbitrary. 
Ravimvormide järjestus on juhuslik.
Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON 
Sloveenia MERIAL 29 avenue Tony Garnier 69007 LYON France
Panomec Injection for Cattle, Sheep and Pigs 
Panomec Injection for Veised, Lambad and Sead
WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days. 
KEELUAEG Veised: liha ja söödav rups - 49 päeva.
Subcutaneous Cattle, Sheep, Goats: 200 μg ivermectin/kg bw 
Subkutaanne Veised, lambad, kitsed: 200 μg ivermektiini/kg kehamassi kohta
Wedemec R Ivermectin 10 mg/ml 
Wedemec R Ivermektiin 10 mg/ml
C/ Esmeralda, 19 
INDUSTRIAL VETERINARIA, S.A. C/ Esmeralda, 19
Subcutaneous 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw 
Subkutaanne 200 μg ivermektiini/kg kehamassi kohta, 2 mg klorsulooni/kg kehamassi kohta
Ivomec Super Injection for Cattle 
Ivomec Super Injection for Veised
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. 
Seetõttu jõudis veterinaarravimite komitee järeldusele, et kõigi veistel kasutamiseks ette nähtud ivermektiini sisaldavate süsteravimite puhul tuleks ivermektiinikomponendile kehtestada ühtne keeluaeg pikkusega 49 päeva.
Diapec R Ivermectin 10 mg/ml 
Diapec R Ivermektiin 10 mg/ml
Formulation groups allocated for the 293 products that are the subject of this referral. 
Esildise aluseks olevad 293 toodet ravimvormi rühmade järgi Ravimvormi rühm
Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON 
Prantsusmaa MERIAL 29 avenue Tony Garnier 69007 LYON France
United Kingdom Chanelle Animal Health Ltd 7 Rodney Street 
Hispaania Chanelle Animal Health Ltd 7 Rodney Street
MAXIMEC Ivermectin 10 mg/ml 
MAXIMEC Ivermektiin 10 mg/ml
Subcutaneous 200 μg ivermectin/kg bw, 5 mg closantel/kg bw 
Subkutaanne 200 μg ivermektiini/kg kehamassi kohta, 5 mg klosanteeli/kg kehamassi kohta
PROMECTINE Ivermectin 10 mg/ml 
PROMECTINE Ivermektiin 10 mg/ml
Ivotan LA Ivermectin 10 mg/ml 
Ivotan LA Ivermektiin 10 mg/ml
Luxembourg 
Barcelona
ECOMECTIN Ivermectin 10 mg/ml 
ECOMECTIN Ivermektiin 10 mg/ml
Belgium Laboratorios Calier SA Barcelones 
Hispaania Laboratorios Calier SA Barcelones
Enovex Injection Ivermectin 10 mg/ml 
Enovex Injection Ivermektiin 10 mg/ml
Paramectin 1% Ivermectin 10 mg/ml 
Paramectin 1% Ivermektiin 10 mg/ml
Ivomec 1% Ivermectin 10 mg/ml 
Ivomec 1% Ivermektiin 10 mg/ml
VALANEQ Ivermectin 10 mg/ml 
VALANEQ Ivermektiin 10 mg/ml
Anisec Injection Ivermectin 10 mg/ml 
Anisec Injection Ivermektiin 10 mg/ml
Cattle, Pigs Subcutaneous Cattle: 200 μg ivermectin/kg bw 
Veised, sead Subkutaanne Veised: 200 μg ivermektiini/kg kehamassi kohta
The Netherlands Chanelle Animal Health Ltd 7 Rodney Street 
Prantsusmaa Chanelle Animal Health Ltd 7 Rodney Street
Maximec Injectie Ivermectin 10 mg/ml 
Maximec Injectie Ivermektiin 10 mg/ml
IVOMEC F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
IVOMEC F Ivermektiin 10 mg/ml, Klorsuloon 100 mg/ml
Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
Ivermektiin 10 mg/ml, Klorsuloon 100 mg/ml
Alfamec 1 % Ivermectin 10 mg/ml 
Alfamec 1 % Ivermektiin 10 mg/ml
Ivermektin S Ivermectin 10 mg/ml 
Ivermektin S Ivermektiin 10 mg/ml
Biomectin 1% Ivermectin 10 mg/ml 
Biomectin 1% Ivermektiin 10 mg/ml
VIRBAMEC Ivermectin 10 mg/ml 
VIRBAMEC VET Ivermektiin 10 mg/ml
VETERMEC Ivermectin 10 mg/ml 
VETERMEC Ivermektiin 10 mg/ml
Euromec Injectie Ivermectin 10 mg/ml 
Euromec Injectie Ivermektiin 10 mg/ml
Pandex 1 % Ivermectin 10 mg/ml 
Pandex 1% Ivermektiin 10 mg/ml
Pandex 1% Ivermectin 10 mg/ml 
Pandex 1 % Ivermektiin 10 mg/ml
Cevamec 1% Ivermectin 10 mg/ml 
Cevamec 1% Ivermektiin 10 mg/ml
Animec Injection Ivermectin 10 mg/ml 
Animec Injection Ivermektiin 10 mg/ml
Ivodad 1% Ivermectin 10 mg/ml 
Ivodad 1% Ivermektiin 10 mg/ml
IVOMEC D Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
IVOMEC D Ivermektiin 10 mg/ml, Klorsuloon 100 mg/ml
Belgium Norbrook Laboratories Limited Station Works 
Hispaania Norbrook Laboratories Limited Station Works
Virbamec F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml 
Virbamec F Ivermektiin 10 mg/ml, Klorsuloon 100 mg/ml
Ecomectin 1 % Ivermectin 10 mg/ml 
Ecomectin 1% Ivermektiin 10 mg/ml
Ecomectin 1% Ivermectin 10 mg/ml 
Ecomectin 1 % Ivermektiin 10 mg/ml
BOVECTIN Ivermectin 10 mg/ml 
BOVECTIN Ivermektiin 10 mg/ml
Topimec Injection Ivermectin 10 mg/ml 
Topimec Injection Ivermektiin 10 mg/ml
Iverktin Injection Ivermectin 10 mg/ml 
Iverktin Injection Ivermektiin 10 mg/ml
FROMMECTIN Ivermectin 10 mg/ml 
FROMMECTIN Ivermektiin 10 mg/ml
IVERTIN Ivermectin 10 mg/ml 
IVERTIN Ivermektiin 10 mg/ml
Bimectin Injectie Ivermectin 10 mg/ml 
Bimectin injection Ivermektiin 10 mg/ml
Subcutaneous Cattle, Reindeer: 200 μg ivermectin/kg bw 
Subkutaanne Veised, põhjapõdrad: 200 μg ivermektiini/kg kehamassi kohta
Av.Los Cerrilos 602 Santiago, 
Bulgaaria Centrovet Ltd. Av.Los Cerrilos 602
United Kingdom Cross Vetpharm Group Ltd, Broomhill Road 
Prantsusmaa Cross Vetpharm Group Ltd, Broomhill Road
Aniject Injection Ivermectin 10 mg/ml 
Aniject Injection Ivermektiin 10 mg/ml
Belgium Cross Vetpharm Group Ltd, Broomhill Road 
Hispaania Cross Vetpharm Group Ltd, Broomhill Road
Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2, 
VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2,
United Kingdom Laboratorios Calier SA Barcelones 
Prantsusmaa Laboratorios Calier SA Barcelones
The Netherlands Dopharma Research B.V. Zalmweg 24 
Madalmaad Dopharma Research B.V.
Iverveto 1% Ivermectin 10 mg/ml 
IVERVETo 1 % Ivermektiin 10 mg/ml
IVERVETo 1 % Ivermectin 10 mg/ml 
Iverveto 1% Ivermektiin 10 mg/ml
Virbamec for Cattle Swine and Sheep 1% 
Virbamec for Veised Swine and Lambad
Belgium ECO Animal Health Ltd 78 Coombe Road 
Bulgaaria ECO Animal Health Ltd 78 Coombe Road
TIZOVAL Ivermectin 10 mg/ml 
TIZOVAL Ivermektiin 10 mg/ml
Czech Republic Norbrook Laboratories Limited Station Works 
Prantsusmaa Norbrook Laboratories Limited Station Works
Slovak Republic ECO Animal Health Ltd 78 Coombe Road 
Hispaania ECO Animal Health Ltd 78 Coombe Road
Sumiject Injection Ivermectin 10 mg/ml 
Sumiject Injection Ivermektiin 10 mg/ml
United Kingdom ECO Animal Health Ltd 78 Coombe Road 
Prantsusmaa ECO Animal Health Ltd 78 Coombe Road
Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017. 
Jylamvo on saanud müügiloa, mis kehtib kogu ELis, 29. märtsil 2017.
What measures are being taken to ensure the safe and effective use of Jylamvo? 
Mis meetmed võetakse, et tagada Jylamvo ohutu ja efektiivne kasutamine?
This especially affects fast-growing cells such as cancer cells. 
See mõjutab eelkõige kiiresti kasvavaid rakke, nt vähirakke.
In most cases, methotrexate medicines are used for long-term treatment. 
Enamikul juhtudel kasutatakse metotreksaatravimeid pikaajaliseks raviks.
Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo. 
Lisateave Jylamvo kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/jylamvo.
The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week. 
Arstil tuleb patsiendi või tema hooldajaga kontrollida, et ravimit saab üks kord nädalas usaldusväärselt manustada.
What is Jylamvo and what is it used for? 
Mis on Jylamvo ja milleks seda kasutatakse?
For inflammatory conditions it is taken once a week, on the same day each week. 
Põletikuhaiguste korral manustatakse Jylamvot kord nädalas samal nädalapäeval.
Why is Jylamvo authorised in the EU? 
Miks Jylamvo ELis heaks kiideti?
How often methotrexate is given depends on the other medicines it is used with. 
Metotreksaadi manustamise sagedus sõltub sellest, mis muude ravimitega seda koos kasutatakse.
Jylamvo (methotrexate) 
Jylamvo (metotreksaat)
As for every medicine, the company provided studies on the quality of Jylamvo. 
Nagu iga ravimi korral, esitas ettevõte Jylamvo kvaliteedi uuringud.
Other information about Jylamvo 
Muu teave Jylamvo kohta
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. 
Metotreksaadi toimemehhanism artriidi ja psoriaasiga patsientidel ei ole päris selge, kuid arvatakse, et metotreksaadi kasulik toime on seotud selle omadusega vähendada põletikku ja pärssida liigaktiivset immuunsüsteemi.
The company will also send out follow-up questionnaires for dosing errors that result in overdose. 
Ettevõte saadab ka välja järelküsimustikud üleannustamist põhjustavate annustusvigade kohta.
The Agency therefore decided that Jylamvo's benefits are greater than its risks and it can be authorised for use in the EU. 
Euroopa Ravimiamet otsustas, et Jylamvo kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment. 
Seda tohib välja kirjutada üksnes metotreksaatravi kasutamise oskustega arst, kes mõistab täielikult metotreksaatravi riske.
For more information about using Jylamvo, see the package leaflet or contact your doctor or pharmacist. 
Lisateavet Jylamvo kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
As for all medicines, data on the use of Jylamvo are continuously monitored. 
Nagu kõigi ravimite puhul, tehakse Jylamvo kasutamise kohta pidevat järelevalvet.
Side effects reported with Jylamvo are carefully evaluated and any necessary action taken to protect patients. 
Jylamvo kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
Jylamvo is an anti-inflammatory and cancer medicine used to treat the following conditions: 
Jylamvo on põletiku- ja vähivastane ravim, mida kasutatakse järgmiste haiguste raviks:
The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses. 
Ettevõte esitas avaldatud kirjandusest pärit andmed metotreksaadi kasulikkuse ja riskide kohta heakskiidetud näidustustel.
What are the risks associated with Jylamvo? 
Mis riskid Jylamvoga kaasnevad?
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. 
Jylamvo turustaja annab tervishoiutöötajatele juhendi ja patsientidele hoiatuskaardi, kuidas ravimit õigesti kasutada ja kuidas vältida ravivigu.
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). 
Ettevõte tegi ka uuringud, mis tõendasid Jylamvo bioekvivalentsust teiste metotreksaati sisaldavate ravimitega, mida kasutatakse põletikuhaiguste ja ägeda lümfoblastleukeemia raviks (Methotrexat Lederle ja Ebetrexat tablettidena).
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. 
Jylamvot ei tohi kasutada patsiendid, kes kuritarvitavad alkoholi või kellel on rasked maksa- või neeruprobleemid, verehäired, nõrgenenud immuunsüsteem (organismi kaitsemehhanismid), rasked või pikaajalised infektsioonid, nt tuberkuloos ja HIV-infektsioon, suuhaavandid, suupõletik ja seedesüsteemi haavandid.