natgillin/translations-raw huggingface dataset:
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.
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.
Jylamvo ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
For acute lymphoblastic leukaemia, the dose of Jylamvo depends on the patient's height and weight.
Ägeda lümfoblastleukeemia korral sõltub Jylamvo annus patsiendi pikkusest ja kehamassist.
This means that it is similar to a ‘reference medicine' containing the same active substance, but Jylamvo is given in a different way.
See tähendab, et Jylamvo on sarnane sama toimeainet sisaldava(te) võrdlusravimi(te)ga, kuid seda manustatakse teisiti.
For the full list of side effects and restrictions of Jylamvo, see the package leaflet.
Jylamvo kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
The European Medicines Agency decided that Jylamvo was of comparable quality and was bioequivalent to the methotrexate-containing medicines Methotrexat Lederle and Ebetrexat.
Euroopa Ravimiamet otsustas, et Jylamvo on samaväärse kvaliteediga ja bioekvivalentne metotreksaati sisaldavate ravimitega Methotrexat Lederle ja Ebetrexat.
The active substance in Jylamvo, methotrexate, stops cells from growing by interfering with the production of DNA.
Jylamvo toimeaine metotreksaat peatab rakkude kasvu, häirides DNA sünteesi.
How is Jylamvo used?
Kuidas Jylamvot kasutatakse?
How does Jylamvo work?
Kuidas Jylamvo toimib?
• 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;
• raske juveniilne idiopaatiline artriit (lastel esinev liigesepõletik) vähemalt 3-aastastel lastel, kui mittesteroidsete põletikuvastastele ravimite (NSAID) toime on olnud ebapiisav;
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.
Kõige raskemad kõrvalnähud on vähenenud vereloome, kopsu-, maksa-, neeru- ja närvikahjustused, trombemboolia (veresoonetrombidest põhjustatud probleemid) ning rasked allergilised ja nahareaktsioonid.
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.
Jylamvo kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on toime seedesüsteemile (nt suulimaskestapõletik, seedehäired, kõhuvalu, iiveldus ja isutus) ning maksafunktsiooni näitajate muutused vereanalüüsis.
Jylamvo is a ‘hybrid medicine'.
Jylamvo on hübriidravim.
• acute lymphoblastic leukaemia (ALL), a cancer of white blood cells, in adults and children over the age of 3 years.
• äge lümfoblastleukeemia (vere valgeliblede vähk) täiskasvanutel ja üle 3-aastastel lastel.
• active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
• aktiivne reumatoidartriit (liigesepõletikku põhjustav haigus) täiskasvanutel;
An overview of Jylamvo and why it is authorised in the EU
Ülevaade ravimist Jylamvo ja ELis müügiloa väljastamise põhjendus
Jylamvo contains the active substance methotrexate.
Jylamvo sisaldab toimeainena metotreksaati.
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.
Patsiendi iganädalane annus oleneb ravitavast põletikuhaigusest, ravi toimivusest ning lastel ka pikkusest ja kehamassist.
• severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
• raske psoriaatiline artriit (psoriaasiga patsientidel esinev liigesepõletik) täiskasvanutel;
It must not be used if the patient is breastfeeding or is receiving live vaccines.
Jylamvot ei tohi kasutada imetavad patsiendid ega elusvaktsiine saavad patsiendid.
What benefits of Jylamvo have been shown in studies?
Milles seisneb uuringute põhjal Jylamvo kasulikkus?
The reference medicine for Jylamvo is Methotrexat Lederle injection.
Jylamvo võrdlusravim on süstitav Methotrexat Lederle.
• severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;
• raske invaliidistav psoriaas (punaseid ketendavaid nahalaike põhjustav põletikuhaigus)
Jylamvo is available as a liquid to be taken by mouth and it can only be obtained with a prescription.
Jylamvot turustatakse suukaudse vedelikuna.
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.
müügiloa hoidja esitab ravimi perioodilisi ohutusaruandeid kooskõlas direktiivi 2001/83/EÜ artikli 107c punktis 7 sätestatud ja Euroopa ravimite veebiportaalis avaldatud liidu kontrollpäevade loetelu (EURD loetelu) nõuetega.
Condition to the marketing authorisations
Müügilubade tingimus
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):
Liikmesriikide või (kui asjakohane) viiteliikmesriikide riiklikud pädevad asutused peavad tagama, et müügiloa hoidjad täidavad järgmisi tingimusi:
Annex IV Condition to the marketing authorisations
IV lisa Müügilubade tingimus
HbA1c, % Not applicable
HbA1c, % Ei kohaldata
The need for continued treatment should be evaluated after 16 weeks (see section 4.1) and reevaluated annually.
Ravi jätkamise vajadust tuleb hinnata pärast 16 nädala möödumist (vt lõik 4.1) ja kord aastas uuesti hinnata.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2015
ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 26 märts 2015