FrancophonIA/ELRC3.0 huggingface dataset:
English: Resume LIBTAYO if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to ≤10 mg/day prednisone or equivalent
Lithuanian: Gydymą LIBTAYO atnaujinti, jei odos reakcija palengvėja iki 0 laipsnio ar 1-ojo laipsnio po laipsniško kortikosteroidų (prednizono ar jo atitikmens) dozės sumažinimo iki ≤ 10 mg per parą
English: • rash, itching
Lithuanian: • išbėrimas, niežėjimas
English: Recommended treatment modifications
Lithuanian: Rekomenduojamas gydymo koregavimas Nepageidaujama reakcija
English: mCSCC cemiplimab: 3 mg/kg Q2W (Group 1) (N = 59)
Lithuanian: Tyrimo 1540 metu nustatyti metastazinė OPLK pagal dozavimo grupę, lokaliai išplitusi OPLK veiksmingumo rezultatai mOPLK 3 mg/kg cemiplimabo Q2W (1 grupė) (N = 59)
English: Nephritis
Lithuanian: Nefritas
English: • Gut problems (colitis) such as frequent diarrhoea often with blood or mucus, more bowel movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain or tenderness.
Lithuanian: dažnesnis nei įprasta tuštinimasis, juodos arba deguto spalvos išmatos ir smarkus skrandžio (pilvo) skausmas ar jautrumas.
English: Skin and subcutaneous skin disorders Rashg
Lithuanian: Odos ir poodinio audinio sutrikimai Išbėrimas g
English: Mix the diluted solution by gentle inversion.
Lithuanian: Maišelį švelniai pavartykite, kad praskiestas tirpalas susimaišytų.
English: Patients should be monitored for signs and symptoms of diarrhoea or colitis and managed with cemiplimab treatment modifications, anti-diarrhoeal agents, and corticosteroids (see section 4.2).
Lithuanian: Būtina stebėti, ar pacientams nepasireiškia viduriavimo ar kolito požymiai ir simptomai, bei kontroliuoti jų būklę koreguojant gydymą cemiplimabu bei skiriant vaistinių preparatų nuo viduriavimo ir kortikosteroidus (žr.
English: Strength Pharmaceutical form
Lithuanian: Stiprumas Farmacinė forma Vartojimo būdas Vidinė pakuotė Pakuotės dydis
English: MA (EU) number (Invented) name
Lithuanian: RP (EU) numeris (Sugalvotas) pavadinimas
English: 200 mg Concentrate for solution for infusion
Lithuanian: 200 mg Koncentratas infuziniam tirpalui
English: Intravenous use vial (glass)
Lithuanian: Leisti į veną flakonas (stiklinis)
English: Strength Pharmaceutical Form
Lithuanian: Farmacinė forma Vartojimo būdas Vidinė pakuotė Kiekis (koncentracija)
English: Pack size
Lithuanian: Stiprum as
English: 1231 Ljubljana- Crnuce Slovenia
Lithuanian: 1231 Ljubljana- Crnuce
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Lithuanian: I PRIEDAS VAISTŲ PAVADINIMŲ, VAISTŲ FORMŲ, STIPRUMO, VARTOJIMO BŪDŲ, REGISTRAVIMO LIUDIJIMŲ TURĖTOJŲ VALSTYBĖSE NARĖSE SĄRAŠAS
English: Nieuwe Donk 3
Lithuanian: V. Nieuwe Donk 3
English: 92300 Levallois-Perret France
Lithuanian: 92300 Levallois-Perret
English: Hampden Park, Eastbourne East Sussex BN22 9AG United Kingdom
Lithuanian: Hampden Park, Eastbourne East Sussex BN22 9AG
English: Alexandriei, nr 145 A B07-Bragadiru, jud Ilfov România
Lithuanian: Alexandriei, nr 145 A B07-Bragadiru, jud Ilfov
English: Slandrova ulica 4
Lithuanian: Ljubljana Slandrova ulica 4
English: Leeds, W Yorkshire LS11
Lithuanian: Leeds, W Yorkshire LS11 9XE
English: North evon EX32 8NS United Kingdom
Lithuanian: North evon EX32 8NS
English: spa Via Scandicci, 37 50143 Firenze Italy
Lithuanian: Via Scandicci, 37 50143 Firenze Italy
English: United Kingdom Teva United Kingdom Limted
Lithuanian: Jungtinė Karalystė Teva United Kingdom Limted
English: 82102 Bratislava
Lithuanian: 82102 Bratislava Slovakia
English: Limassol Industrial Estate Aharnon Street P.O.
Lithuanian: Limassol Industrial Estate Aharnon Street
English: Sanofi Aventis France 1-13, boulevard Romain Rolland
Lithuanian: Sanofi Aventis France 1-13, boulevard Romain
English: S.C. BIOFARM S.A.
Lithuanian: BIOFARM S.A.
English: B-dul Theodor Pallady nr. 44C
Lithuanian: B-dul Theodor Pallady nr.
English: Hospira Italia srl Via Orazio, 20/22 80122 NAPOLI Italy
Lithuanian: Via Orazio, 20/22 80122 NAPOLI
English: Teofarma srl Via Fratelli Cervi, 8 27010 Valle Salimbene Pavia
Lithuanian: Via Fratelli Cervi, 8 27010 Valle Salimbene Pavia
English: United Kingdom Accord Healthcare Ltd Sage House
Lithuanian: Jungtinė Karalystė Accord Healthcare Ltd Sage House
English: Czech Republic Teva Pharmaceuticals CR, s.r.o.
Lithuanian: Čekijos Respublika Teva Pharmaceuticals CR, s.r.o.
English: 4879 AC Etten Leur The Netherlands
Lithuanian: 4879 AC Etten Leur
English: Pharmaceutical Works POLPHARMA SA 19 Pelplińska Street 83-200 Starogard Gdański Poland
Lithuanian: POLPHARMA SA 19 Pelplińska Street 83-200 Starogard Gdański
English: Accord Healthcare B.V. De Waterman 15 A 4891 TL Rijsbergen The Netherlands
Lithuanian: De Waterman 15 A 4891 TL Rijsbergen
English: 49, avenue Georges Pompidou
Lithuanian: 49, avenue Georges
English: 75016 Paris
Lithuanian: 75016 Paris France
English: Mercury Pharmacuticals (Ireland) Ltd 4045 Kingswood Road Citywest Business Park Co. Dublin
Lithuanian: Mercury Pharmacuticals (Ireland) Ltd 4045 Kingswood Road Citywest Business Park
English: D-82041 Oberhaching Germany
Lithuanian: D-82041 Oberhaching
English: 1 - 1 - Venda Nova 2700-547 Amadora Portugal
Lithuanian: 2700-547 Amadora Portugal
English: Luxembourg Hexal AG Industriestr.
Lithuanian: HEXAL AG Industriestr.
English: S.C. MEDUMAN S.A.
Lithuanian: MEDUMAN S.A.
English: Meda Pharma France 25, boulevard de l'Amiral Bruix
Lithuanian: 25, boulevard de l'Amiral
English: United Kingdom Chelonia Healthcare Limited
Lithuanian: Jungtinė Karalystė Chelonia Healthcare Limited
English: Radlická 3185/1c
Lithuanian: Radlická 3185/1c 150 00 Prague Czech Republic
English: 1-10, Constantinoupleos Street
Lithuanian: 1-10, Constantinoupleos
English: Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Lithuanian: 2740-244 Porto Salvo
English: United Kingdom Generics (United Kingdom) Limited
Lithuanian: Jungtinė Karalystė Generics (United Kingdom) Limited
English: PROKINYL L.P. 15 mg, gélule à libération prolongée
Lithuanian: 15 mg, gélule à libération prolongée
English: Gloucester GL3 4AG
Lithuanian: Gloucester GL3 4AG United Kingdom
English: F.I.R.M.A.
Lithuanian: F.I.R.
English: Sanofi Aventis AEBE 348 Syngrou avenue Building A
Lithuanian: Sanofi Aventis AEBE 348 Syngrou avenue
English: Farmakopea spa Via Cavriana, 14 20134 MILANO Italy
Lithuanian: Via Cavriana, 14 20134 MILANO
English: Nexus, Gloucester
Lithuanian: Nexus, Gloucester Business
English: D-89079 Ulm mcP Ratiopharm SF
Lithuanian: D-89079 Ulm Germany mcP Ratiopharm SF
English: United Kingdom Mercury Pharma International Limited 4045 Kingswood Raod City West Business Park County Dublin
Lithuanian: International Limited 4045 Kingswood Raod City West Business Park County Dublin Ireland
English: Str. Logofăt Tăutu, nr. 99 sector 3, Bucureşti 031212 Romania
Lithuanian: 99 sector 3, Bucureşti 031212
English: 83-200 Starogard Gdański Poland
Lithuanian: Pelplińska 19 83-200 Starogard Gdański
English: DIGESTIVO S.PELLEGRINO 5mg
Lithuanian: DIGESTIVO S.PELLEGRINO
English: United Kingdom Amdipharm plc Regency House
Lithuanian: Jungtinė Karalystė Amdipharm plc
English: Techni-Pharma 7, rue de l'Industrie BP 717
Lithuanian: 7, rue de l'Industrie
English: Sopharma PLC 16 Iliensko Shosse Str. Sofia
Lithuanian: 16 Iliensko Shosse Str.
English: S.C. LAROPHARM S.R.L.
Lithuanian: LAROPHARM S.R.L.
English: Metoclopramidum 0,5% Polpharma
Lithuanian: Metoclopramidum 0,5%
English: Abbott Arzneimittel GmbH Freundallee 9A 30173 Hannover Germany
Lithuanian: Abbott Arzneimittel GmbH Freundallee 9A
English: Middlesex HA1 4HF
Lithuanian: Middlesex HA1 4HF United Kingdom
English: Orion Corporation Orionintie 1A FI-02200 Espoo Finland
Lithuanian: Orion Corporation Orionintie 1A
English: Yorkdale Industrial Park Braithwaite Street
Lithuanian: Yorkdale Industrial Park
English: Miles Gray Road, Basildon Essex SS14 3AF
Lithuanian: Miles Gray Road, Basildon
English: S.C. SLAVIA PHARM S.R.L.
Lithuanian: SLAVIA PHARM S.R.L.
English: Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki Finland
Lithuanian: Huopalahdentie 24 00350 Helsinki Finland
English: Laboratório MedinfarProdutos Farmacêuticos, S.A. l Ribeiro de Pavia, 1 - 1ºVenda Nova 2700-547 Amadora Portugal
Lithuanian: l Ribeiro de Pavia, 1 - 1ºVenda Nova 2700-547
English: London W1H 1DP
Lithuanian: 78 York Street London W1H 1DP United Kingdom
English: Sanofi-Aventis spa Viale Luigi BODIO, 37/B 20158 Milano Italy
Lithuanian: Sanofi-Aventis spa Viale Luigi BODIO, 37/B
English: Sanofi-Aventis Netherlands B.V.
Lithuanian: Sanofi-Aventis Netherlands B.
English: MCP-ratiopharm 10mg Zäpfchen
Lithuanian: MCP-ratiopharm 10mg Zäpfchen 10 mg
English: 1372 Asker Norway
Lithuanian: Postboks 205 1372 Asker Norway
English: Wasastrasse 50
Lithuanian: Wasastrasse 50 Radebeul
English: Czech Republic Lek Pharmaceuticals d.d.
Lithuanian: Čekijos Respublika Lek Pharmaceuticals d.d.
English: Luxembourg Dolorgiet Gmbh&Co Otto-von-Guericke-Str. 1
Lithuanian: Dolorgiet Gmbh&Co Otto-von-Guericke-Str.
English: Annex I
Lithuanian: Building A
English: Pensa Pharma, S.A.U Jorge Comín (médico pediatra)
Lithuanian: Pensa Pharma, S.A.U Jorge Comín (médico pediatra) 3 - 46015 Valencia Spain
English: Rua Manuel Ribeiro de Pavia
Lithuanian: Rua Manuel Ribeiro de Pavia 1 - 1 - Venda Nova
English: Laboratoire Renaudin Z A. Errobi
Lithuanian: Laboratoire Renaudin
English: Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2 ml
Lithuanian: Primperan injectie 10/2 ml, oplossing voor injection 10 mg/2
English: Sanofi-Aventis Belgium N.V.
Lithuanian: Sanofi-Aventis Belgium N.
English: United Kingdom Rosemont Pharmaceuticals Limited
Lithuanian: Jungtinė Karalystė Rosemont Pharmaceuticals Limited
English: United Kingdom Hameln Pharmaceuticals Limited
Lithuanian: Jungtinė Karalystė Hameln Pharmaceuticals Limited
English: 3542 DR Utrecht The Netherlands
Lithuanian: Computerweg 10 3542 DR Utrecht
English: Medochemie Limited 1-10 Constantinoupleos Str
Lithuanian: Medochemie Limited 1-10 Constantinoupleos Str 3011 Limassol Cyprus
English: Boumpoulinas 11, 3rd Floor
Lithuanian: Boumpoulinas 11, 3rd Floor Nicosia, CY-1060
English: United Kingdom Metwest Pharmaceuticals Limited
Lithuanian: Jungtinė Karalystė Metwest Pharmaceuticals Limited
English: Panpharma ZI du Clairay Luitré 35133 Fougères France
Lithuanian: 35133 Fougères France
English: S.C.
Lithuanian: Z A.
English: Mylan SAS 117, allée des Parcs 69800 Saint-Priest France
Lithuanian: 69800 Saint-Priest France
English: United Kingdom Pharmvit Limited 177 Bilton Road, Perivale Middlesex UB6 7HQ United Kingdom
Lithuanian: Jungtinė Karalystė Pharmvit Limited 177 Bilton Road, Perivale
English: Solution for injection Intravenous use
Lithuanian: Solution for Injection
English: 01445 Radebeul
Lithuanian: 01445 Radebeul Germany
English: Metoclopramid AWD 10 mg Tabletten axcount Generika AG Max-Planck-Str. 36b D-61381 Friedrichsdorf Germany
Lithuanian: Metoclopramid AWD 10 mg Tabletten axcount Generika AG Max-Planck-Str.
English: Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Lithuanian: 2803 PE GOUDA The Netherlands
English: S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj - Napoca 400632 România
Lithuanian: Cluj - Napoca 400632
English: ARENA GROUP S.A Str. Stefan Mihaileanu, nr.31 sector 2; Bucuresti 024022 România
Lithuanian: sector 2; Bucuresti 024022 România
English: Czech Republic Hexal AG Industriestrasse 25
Lithuanian: Čekijos Respublika Hexal AG
English: Sirton Medicare spa Piazza XX Settembre, 2 22079 Villa GuardiaCOMO
Lithuanian: Piazza XX Settembre, 2
English: Modified-release capsule, soft
Lithuanian: Modifikuoto atpalaidavimo minkštoji kapsulė
English: Labesfal - Laboratórios Almiro, S.A.
Lithuanian: Labesfal - Laboratórios
English: PRIMPERAN 20 mg, suppositoire
Lithuanian: PRIMPERAN 20 mg, suppositoire 20 mg
English: Sanofi Aventis Cyprus ltd Charalambou Mouskou 14 2015 Strovolos Nicosia Cyprus
Lithuanian: Sanofi Aventis Cyprus ltd
English: Maxolon High Dose 100mg/20ml
Lithuanian: Maxolon High Dose 100mg/20ml 0.5% w/v
English: Chandler House Castle Street, Roscrea County Tipperary Ireland
Lithuanian: Castle Street, Roscrea
English: 75014 Paris
Lithuanian: Rolland 75014 Paris France
English: Polhampton Lane, Overton Hampshire RG25 3ED
Lithuanian: Polhampton Lane, Overton
English: CHLORHYDRATE DE METOCLOPRAMIDE RENAUDIN 10 mg/2 ml, solution injectable en ampoule
Lithuanian: METOCLOPRAMIDE RENAUDIN 10 mg/2 ml, solution injectable en ampoule
English: Slovak Republic Sandoz Pharmaceuticals d.d.
Lithuanian: Sandoz Pharmaceuticals d.d.
English: MCP-ratiopharm SF 10mg/2ml Injektionslösung ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Lithuanian: MCP-ratiopharm SF 10mg/2ml Injektionslösung ratiopharm GmbH Graf-Arco-Str.
English: United Kingdom Actavis UK Limited Whiddon Valley
Lithuanian: Jungtinė Karalystė Actavis UK Limited
English: METOCLOPRAMID ARENA 10 mg
Lithuanian: METOCLOPRAMID ARENA 10 mg 10 mg
English: Alkaloid Ltd 2 Ricardo Vakarini str. Sofia
Lithuanian: 2 Ricardo Vakarini str.
English: Luxembourg Eurogenerics s.a. Heizel Esplanade B22
Lithuanian: Heizel Esplanade B22 1020 Laeken Belgium
English: Luxembourg Nycomed Belgium s.a. 615, chaussee de Gand B-1080 Bruxelles
Lithuanian: 615, chaussee de Gand
English: Str. Aleea Eroilor nr. 28, Vişeu de Sus, Judeţul Maramureş 435700 România
Lithuanian: Judeţul Maramureş 435700
English: D-89079 Ulm
Lithuanian: D-89079 Ulm Germany
English: Intramuscular use Intravenous use
Lithuanian: Injekcinis tirpalas Parenterinis vartojimas
English: Primperan drank, drank 1 mg/ml
Lithuanian: Primperan drank, drank
English: Temmler Pharma GmbH & Co
Lithuanian: Temmler Pharma GmbH &
English: Accord Healthcar Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
Lithuanian: Accord Healthcar Ltd Sage House 319 Pinner Road
English: Modified-release capsules, hard
Lithuanian: Modifikuoto atpalaidavimo kietoji kapsulė
English: Sanofi - Produtos Farmacêuticos, Lda.
Lithuanian: Farmacêuticos, Lda.
English: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str. 1 D-53757 Sankt Augustin Germany
Lithuanian: Dolorgiet GmbH & Co.KG Otto-von-Guericke-Str.
English: Accord Healthcare Ltd Sage House 319 Pinner Road North Harrow Middlesex HA1 4HF United Kingdom
Lithuanian: Accord Healthcare Ltd Sage House 319 Pinner Road
English: Business Park
Lithuanian: Park
English: Prolonged-release capsule, hard
Lithuanian: Prailginto atpalaidavimo kietoji kapsulė
English: MCP AbZ 5 mg/ml Tropfen 5.91mg/ml
Lithuanian: MCP AbZ 5 mg/ml Tropfen
English: Oral solution betapharm Arzneimittel GmbH
Lithuanian: Geriamasis tirpalas betapharm Arzneimittel GmbH
English: Metoclopramide HCl CF 10 mg, tabletten
Lithuanian: Metoclopramide HCl CF 10 mg,
English: Slovak Republic TEVA Pharmaceuticals Slovakia s.r.o.
Lithuanian: Slovakia s.r.o.
English: Mylan dura GmbH Wittichstr.
Lithuanian: Mylan dura GmbH
English: Stadapharm GmbH Stadastr.
Lithuanian: Stadapharm GmbH
English: 2031 GA HAARLEM The Netherlands
Lithuanian: Swensweg 5 2031 GA HAARLEM
English: MCP-ratiopharm 10 mg Tabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Lithuanian: MCP-ratiopharm 10 mg Tabletten 11.82 mg ratiopharm GmbH Graf-Arco-Str.
English: Teva Pharma B.V. Computerweg 10
Lithuanian: Teva Pharma B.
English: Prolonged-release capsule ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Lithuanian: Pailginto atpalaidavimo kapsulė ratiopharm GmbH Graf-Arco-Str.
English: Radebeul 1445
Lithuanian: Wasastrasse 50 Radebeul 1445 Germany
English: Sweden sanofi-aventis AB Box 14142
Lithuanian: Švedija sanofi-aventis AB
English: Nycomed Pharma AS Postboks 205
Lithuanian: Nycomed Pharma AS
English: Metoclopramide Hydrochloride 5mg/5ml Oral Solution
Lithuanian: 5mg/5ml Oral Solution
English: Laboratório MedinfarProdutos Farmacêuticos, S.A.
Lithuanian: Produtos Farmacêuticos, S.
English: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Lithuanian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str.
English: United Kingdom Crescent Pharma Limited Units 3 & 4
Lithuanian: Jungtinė Karalystė Crescent Pharma Limited
English: 83607 Holzkirchen Germany
Lithuanian: Industriestrasse 25 83607 Holzkirchen Germany
English: KG, Temmlerstrasse 2 DE-35039 Marburg Germany
Lithuanian: KG, Temmlerstrasse 2
English: Concentrate for solution for infusion
Lithuanian: Koncentratas infuziniam tirpalui
English: Paspertin 10 mg - Ampullen 10mg/2ml
Lithuanian: Paspertin 10 mg - Ampullen
English: Metoclopramide HCl 10 PCH, tabletten 10 mg
Lithuanian: Metoclopramide HCl 10 PCH,
English: United Kingdom Ennogen Limited 78 York Street
Lithuanian: Jungtinė Karalystė Ennogen Limited
English: Metoclopramide 10mg Tablets 10mg
Lithuanian: Metoclopramide 10mg Tablets
English: Elitan Injection, 10mg/2ml, Solution for Injection
Lithuanian: Elitan Injection, 10mg/2ml,
English: Metoclo-hameln 5mg/ml, Injektionslösung
Lithuanian: Metoclo-hameln 5mg/ml,
English: CSC Pharmaceuticals Ltd. 10 Assen Yordanov str. Sofia
Lithuanian: 10 Assen Yordanov str.
English: Long-term exposure (at least 48 weeks)
Lithuanian: Ilgalaikė (mažiausiai 48 savaičių) ekspozicija
English: Tell your doctor.
Lithuanian: Pasakykite gydytojui.
English: Consequently, newborns should be monitored carefully.
Lithuanian: Dėl šios priežasties naujagimiai turi būti atidžiai stebimi.
English: Patients should be closely monitored during this period.
Lithuanian: Šiuo laikotarpiu pacientus reikia labai atidžiai stebėti.
English: Interaction studies have only been performed in adults.
Lithuanian: Sąveikos tyrimai atlikti tik suaugusiems.
English: Package leaflet: Information for the user
Lithuanian: PAKUOTĖS LAPELIS: INFORMACIJA VARTOTOJUI
English: Information on long term safety is primarily limited to open-label, uncontrolled data.
Lithuanian: Informacija apie ilgalaikį saugumą yra ribota, nes visų pirma yra pagrįsta atviru būdu surinktais nekontroliuojamaisiais duomenimis.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Lithuanian: Kai kuriems iš jų prieš tai padidėjo kūno svoris, kas galėjo būti predisponuojančiu veiksniu.
English: There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Lithuanian: Kontroliuojamųjų duomenų apie ilgalaikį poveikį ar ilgalaikį saugumą nėra (žr. 4.4 ir 4.8 skyrius).
English: These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Lithuanian: Šie simptomai gali laikinai pablogėti ar net ir atsirasti nutraukus.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included 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.
Lithuanian: Tačiau registruotojas teikia šio vaistinio preparato periodiškai atnaujinamus saugumo protokolus, jei preparatas įtrauktas į Direktyvos 2001/83/EB 107c straipsnio 7 dalyje numatytą Sąjungos referencinių datų sąrašą (EURD), kuris skelbiamas Europos vaistų tinklalapyje.
English: Decreased bioavailability
Lithuanian: Sumažėjęs biologinis prieinamumas
English: Show the doctor your pack of tablets.
Lithuanian: Gydytojui parodykite tablečių pakuotę.
English: • Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Lithuanian: • Pasakykite gydytojui jeigu Jums arba kuriam nors Jūsų kraujo giminaičiui kraujagyslėse buvo susiformavę kraujo krešuliai, nes į šį vaistą panašūs vaistai yra susiję su kraujo krešulių formavimusi.
English: Discontinuation symptoms7, 12
Lithuanian: Nutraukimo simptomai7, 12
English: Take your tablets as soon as you remember.
Lithuanian: Tabletes išgerkite tuojau pat prisiminę.
English: Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Lithuanian: Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Airija Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Jungtinė Karalystė.
English: Some fatal cases have been reported in this particular group of patients.
Lithuanian: Buvo keli šios grupės pacientų mirties atvejai.
English: • Prostate problems
Lithuanian: • Prostatos problemos
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Lithuanian: TEKSTO PERŽIŪROS DATA {MMMM month dd.
English: Do not take a double dose to make up for the forgotten tablet.
Lithuanian: Negalima vartoti dvigubos dozės norint kompensuoti praleistą tabletę.
English: This will usually pass on its own but if it does not, tell your doctor.
Lithuanian: Tai paprastai praeina savaime, bet jeigu poveikis neišnyksta, kreipkitės į savo gydytoją.
English: Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Lithuanian: Demografiniai paauglių ir suaugusiųjų skirtumai yra šie: vidutinis paauglių kūno svoris yra mažesnis, mažiau paauglių rūko.
English: Signs and symptoms
Lithuanian: Požymiai ir simtomai
English: Bottles: After first opening use within 90 days.
Lithuanian: Buteliukai: Pirmą kartą atidarius suvartoti per 90 dienų.
English: Increased total bilirubin
Lithuanian: Bendrojo bilirubino koncentracijos padidėjimas
English: Your doctor will tell you how many Olanzapine Mylan tablets to take and how long you should continue to take them.
Lithuanian: Gydytojas pasakys, po kiek OLANZAPINAS MYLAN tablečių gerti ir kiek laiko jų vartoti.
English: There are no adequate and well-controlled studies in pregnant women.
Lithuanian: Nėra adekvačių ir gerai kontroliuojamų olanzapino poveikio nėščiajai tyrimų.
English: When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Lithuanian: Kai yra daugiau nei vienas veiksnys, galintis lėtinti metabolizmą (moteriška lytis, senyvas amžius, nerūkymas), turi būti sprendžiamas mažesnės pradinės dozės skyrimas.
English: People with this disease may also feel depressed, anxious or tense.
Lithuanian: Žmonės, sergantys šia liga, gali jaustis prislėgti, apimti nerimo ar įsitempę.
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lithuanian: Šis vaistas, kaip ir visi kiti, gali sukelti šalutinį poveikį, nors jis pasireiškia ne visiems žmonėms.
English: • Diabetes
Lithuanian: • Diabetas
English: After first opening use within 90 days.
Lithuanian: Pirmą kartą atidarius suvartoti per 90 dienų.
English: The efficacy of olanzapine was not established in these trials.
Lithuanian: Šių tyrimų metu olanzapino veiksmingumas nebuvo nustatytas.
English: Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Lithuanian: Olanzapino nerekomenduojama vartoti vaikams ir jaunesniems kaip 18 metų paaugliams, nes duomenų apie saugumą ir veiksmingumą nepakanka.
English: Hyperglycaemia and diabetes
Lithuanian: Hiperglikemija ir diabetas
English: The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Lithuanian: Didesnis mirčių dažnis nebuvo susijęs su olanzapino doze (vidutinė paros dozė 4,4 mg) ar gydymo trukme.
English: • if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Lithuanian: - Jeigu anksčiau buvo diagnozuota akių liga, pavyzdžiui, kurio nors tipo glaukoma (akispūdžio padidėjimas).
English: Dystonia (including oculogyration)11
Lithuanian: Distonija (įskaitant okulogiraciją)11
English: If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Lithuanian: Jei sergate demencija, Jūs arba Jumis besirūpinantis asmuo ar giminaitis turi pranešti gydytojui, jei Jums kada nors yra buvęs insultas arba „mikro“ insultas.
English: McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange road
Lithuanian: t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road