FrancophonIA/ELRC3.0 huggingface dataset:
English: Protopy 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Latvian: Protopy 0,1% ziedi lieto, lai ārstētu vidēji smagu vai smagu atopisku dermatītu (ekzēmu) pieaugušiem pacientiem, kuri adekvāti nereaģē uz parasto terapiju, piemēram, lokāli lietotiem kortikosteroīdiem, vai to nepanes.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Latvian: 2. KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS 1 g Protopy 0,03% ziede satur 0,3 mg tacrolimus kā takrolima monohidrātu (0,03%).
English: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Germany
Latvian: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Vācija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Latvian: 2. KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS 1 g Protopy 0,1% ziede satur 1,0 mg tacrolimus kā takrolima monohidrātu (0,1%).
English: A white to slightly yellowish ointment.
Latvian: Balta vai viegli dzeltenīga ziede.
English: Astellas Pharma B.V. Elisabethhof 19
Latvian: Elisabethhof 19
English: Apply Protopy as a thin layer to affected areas of your skin.
Latvian: Uzziediet Protopy plānā slānī uz ādas skartajiem rajoniem.
English: INSTRUCTIONS ON USE
Latvian: Lietošanai uz ādas
English: Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Latvian: Vidēji smaga vai smaga atopiska dermatīta ārstēšanā pieaugušiem pacientiem, kuri adekvāti nereaģē uz parasto terapiju, piemēram, lokāli lietotiem kortikosteroīdiem, vai to nepanes.
English: Acne is an uncommon side effect.
Latvian: Pinnes ir retāka blakusparādība.
English: BEFORE YOU USE PROTOPY
Latvian: 2. PIRMS PROTOPY LIETOŠANAS
English: In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. AUC) of tacrolimus from Protopy is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients.
Latvian: AUC) no Protopy ir apmēram 30 reizes mazāka, salīdzinot ar to, kāda novērota pēc perorālām imūnsupresīvām devām pacientiem ar nieru un aknu transplantātiem.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.03% OINTMENT (10 g TUBE)
Latvian: MINIMĀLĀ INFORMĀCIJA IZVIETOJAMĀ UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMĀ PROTOPY 0,03% ZIEDE (10 g TŪBA)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.1% OINTMENT (10 g TUBE)
Latvian: MINIMĀLĀ INFORMĀCIJA IZVIETOJAMĀ UZ MAZA IZMĒRA TIEŠĀ IEPAKOJUMĀ PROTOPY 0,1% ZIEDE (10 g TŪBA)
English: One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Latvian: Viens grams Protopy 0,03% ziedes satur 0,3 mg takrolima (takrolima monohidrāta veidā).
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
Latvian: Bieži novērota arī alkohola nepanesamība (sejas pietvīkums, vai ādas kairinājums pēc alkoholisku dzērienu lietošanas).
English: One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Latvian: Viens grams Protopy 0,1% ziedes satur 1,0 mg takrolima (takrolima monohidrāta veidā).
English: Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
Latvian: Ir pieejamas divas Protopy koncentrācijas (Protopy 0,03% un Protopy 0,1% ziede).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA PROTOPY 0,1% ZIEDE (10 g, 30 g, 60 g KĀRBA)
English: Liquid paraffin
Latvian: Parafīneļļa
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/006 10 g
Latvian: 12. REĢISTRĀCIJAS NUMURI EU/1/02/202/006 10 g
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate),
Latvian: 2. AKTĪVĀS VIELAS NOSAUKUMS UN DAUDZUMS 1 g ziedes satur: 0,3 mg tacrolimus kā takrolima monohidrātu (0,03%),
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.03% ointment
Latvian: 1. ZĀĻU NOSAUKUMS Protopy 0,03% ziede
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ ĀRĒJĀ IEPAKOJUMA PROTOPY 0,03% ZIEDE (10 g, 30 g, 60 g KĀRBA)
English: Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
Latvian: Uz ādas rajoniem, kur uzziež Protopy ziedi, 2 stundas nedrīkst lietot mīkstinošus līdzekļus.
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate),
Latvian: 2. AKTĪVĀS VIELAS NOSAUKUMS UN DAUDZUMS 1 g ziedes satur: 1,0 mg tacrolimus kā takrolima monohidrātu (0,1%),
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/005 10 g
Latvian: 12. REĢISTRĀCIJAS NUMURI EU/1/02/202/005 10 g
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Latvian: 13. SĒRIJAS NUMURS Sērija: {numurs}
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ TIEŠĀ IEPAKOJUMA PROTOPY 0,03% ZIEDE (30 g, 60 g TŪBA)
English: Astellas Pharma Ges.m.b.H.
Latvian: Astellas Pharma B.V.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.1% OINTMENT (30 g, 60 g TUBE)
Latvian: INFORMĀCIJA, KAS JĀNORĀDA UZ TIEŠĀ IEPAKOJUMA PROTOPY 0,1% ZIEDE (30 g, 60 g TŪBA)
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/003 30 g
Latvian: 12. REĢISTRĀCIJAS NUMURI EU/1/02/202/003 30 g
English: What Protopy looks like and contents of the pack Protopy is a white to slightly yellowish ointment.
Latvian: Protopy ir balta vai viegli dzeltenīga ziede.
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.1% ointment
Latvian: 1. ZĀĻU NOSAUKUMS Protopy 0,1% ziede
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/003
Latvian: 9. REĢISTRĀCIJAS NUMURI EU/1/02/202/003
English: Name and address of the manufacturer responsible for batch release Astellas Ireland Co. Ltd.,
Latvian: Ražotājs: Astellas Ireland Co.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/001 30 g
Latvian: 12. REĢISTRĀCIJAS NUMURI EU/1/02/202/001 30 g
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Latvian: Pieaugušiem pacientiem pieejami divi Protopy stiprumi (Protopy 0,03% un Protopy 0,1% ziede).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.03% Ointment
Latvian: 1. ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS Protopy 0,03% Ziede
English: Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) Metabolism and nutrition disorders Common:
Latvian: Nervu sistēmas traucējumi Bieži: Parestēzijas un diastēzijas (hiperestēzija, dedzinoša sajūta)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.1% Ointment
Latvian: 1. ZĀĻU NOSAUKUMS UN IEVADĪŠANAS VEIDS Protopy 0,1% Ziede
English: Rosacea and rosacea-like dermatitis have also been reported.
Latvian: Ir ziņojumi par rozāciju un rozācijai līdzīgu dermatītu.
English: Astellas Pharma Co. Ltd.
Latvian: Astellas Pharma Co.
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients (16 years of age and older).
Latvian: Pieaugušiem pacientiem (no 16 gadu vecuma) pieejami divi Protopy stiprumi (Protopy 0,03% un Protopy 0,1% ziede).
English: General disorders and administration site conditions Very common: Application site burning, application site pruritus Common:
Latvian: Ādas un zemādas audu bojājumi Bieži: Folikulīts, nieze Retāk:
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/001
Latvian: 8. REĢISTRĀCIJAS NUMURI EU/1/02/202/001
English: Via delle Industrie 1 I-20061 Carugate (Milano) Tel: +39 (0)2 921381
Latvian: Astellas Pharma S.p.A. Via delle Industrie 1 I-20061 Carugate (Milano)
English: This summary was last updated in 10-2006.©EMEA 2006
Latvian: Šis kopsavilkums pedejo reizi tika atjauninats 10-2006.©EMEA 2006
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Latvian: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: The patient's blood sugar should be tested regularly to find the lowest effective dose.
Latvian: Regulāri jāpārbauda cukura līmenis slimnieku asinīs, lai noteiktu zemāko efektīvo devu.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ultratard to Novo Nordisk A/S in on 7 October 2002.
Latvian: Eiropas Komisija 2002. gada 7. oktobrī piešķīra Ultratard reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam Novo Nordisk A/S.
English: In type 1 diabetes, the dosage varies between 0.5 and 1.0 IU/kg (0.7 and 1.0 IU/kg in children before puberty), in type 2 diabetes the dosage is 0.3 to 0.6 IU/kg.
Latvian: Slimniekiem ar 1. tipa diabētu šī deva svārstās no 0,5 līdz 1,0 SV/kg (0,7 līdz 1,0 SV/kg bērniem, kas nav sasnieguši pubertāti), slimniekiem ar 2. tipa diabētu tā ir 0,3 līdz 0,6 SV/kg.
English: By controlling the blood sugar, the symptoms and complications of diabetes are reduced.
Latvian: Regulējot cukura saturu asinīs, tas samazina diabēta simptomus un komplikācijas.
English: Other information about Ultratard:
Latvian: Cita informācija par Ultratard
English: The Committee for Medicinal products for Human Use (CHMP) decided that Ultratard's benefits are greater than its risks for the treatment of diabetes.
Latvian: Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka Ultratard ieguvumi pārsniedz tā radīto risku, ārstējot diabēta slimniekus.
English: Ultratard is an insulin suspension for injection.
Latvian: Ultratard ir insulīna suspensija injekcijām.
English: The full EPAR for Ultratard is available here.
Latvian: Pilns Ultratard EPAR teksts ir atrodams šeit.
English: Why has Ultratard been approved?
Latvian: Kāpēc Ultratard tika apstiprināts?
English: Ultratard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Latvian: Ultratard deva ir jāpielāgo, ja to lieto kopā ar dažām citām zālēm, kas var ietekmēt cukura līmeni asinīs (pilns saraksts ir ietverts zāļu lietošanas pamācībā).
English: Ultratard is a long-acting insulin, it can be given as a once daily or twice daily injection, with or without a fast-acting insulin (at meal times), according to the doctor's recommendation.
Latvian: Ultratard ir ilgstošas darbības insulīns, to var injicēt vienreiz vai divreiz dienā kopā ar ātras darbības insulīnu (ēšanas laikā) vai bez tā, ievērojot ārsta ieteikumus.
English: Ultratard can be used in type 1 diabetes, when the pancreas cannot produce insulin, and in type 2 diabetes, when the body is not able to use insulin effectively.
Latvian: Ultratard var lietot slimnieki ar 1. tipa diabētu, kuru aizkuņģa dziedzeris nespēj ražot insulīnu, un slimnieki ar 2. tipa diabētu, kuru organisms nespēj efektīvi izmantot insulīnu.
English: Ultratard is given subcutaneously (under the skin) by injection, usually in the thigh.
Latvian: Ultratard ievada subkutāni (zem ādas), to parasti injicē gurnā.
English: Ultratard may cause hypoglycaemia (low blood sugar).
Latvian: Ultratard var izraisīt hipoglikēmiju (pazemināt cukura līmeni asinīs).
English: Ultratard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Latvian: Ultratard nedrīkst lietot pacienti, kas ir īpaši jutīgi (kam ir alerģija) pret cilvēka insulīnu (rDNS) vai kādu citu sastāvdaļu.
English: The studies measured the level of fasting blood sugar or a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood sugar is controlled.
Latvian: Šajos pētījumos noteica cukura vai citas vielas (glikozilētā hemoglobīna HbA1c) līmeni asinīs tukšā dūšā, pēc kura var spriest, cik labi tiek regulēts cukura līmenis asinīs.
English: Ultratard was effective for both Type 1 and Type 2 diabetes.
Latvian: Ultratard ir iedarbīgs gan pret 1. tipa, gan pret 2. tipa diabētu.
English: Ultratard has been studied in both type 1 and type 2 diabetes, and it has been compared to other types of insulin (porcine, human).
Latvian: Ultratard tika ordinēts slimniekiem ar 1. un 2. tipa diabētu, salīdzinot to ar citas izcelsmes (cūkas, cilvēka) insulīnu.
English: Ultratard is used in patients with diabetes mellitus.
Latvian: Ultratard lieto cukura diabēta slimnieki.
English: Ultratard contains the active ingredient insulin human (rDNA).
Latvian: Ultratard satur aktīvo sastāvdaļu - cilvēka insulīnu (rDNS).
English: The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Latvian: Insulīnu sintezē rauga šūnas, kurās ir ievadīts gēns (DNS), kas ļauj tām ražot insulīnu.
English: Ultratard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Latvian: Ultratard pazemina HbA1c koncentrāciju, kas norāda, ka cukurs asinīs ir sasniedzis tādu pašu līmeni, kā lietojot citas izcelsmes cilvēka insulīnu.
English: Ultratard contains insulin mixed with another substance, zinc, in particles from which the insulin is absorbed much more slowly during the day; and this gives Ultratard a longer duration of action.
Latvian: Ultratard satur insulīnu, kas ir sajaukts ar cinka daļiņām, no kurām tas daudz lēnāk uzsūcas dienas laikā, kas nodrošina Ultratard ilgāku iedarbību.
English: If convenient it may also be given in the abdominal wall (tummy), the buttocks or the deltoid region (shoulder).
Latvian: Ērtības labad to var ievadīt arī vēdera sienā, sēžas muskulī vai deltveida muskulī pleca apvidū.
English: What is the risk associated with Ultratard?
Latvian: Kāds pastāv risks, lietojot Ultratard?
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood sugar.
Latvian: Diabēta slimnieku organisms nespēj pietiekamā daudzumā saražot insulīnu, kas regulē cukura līmeni asinīs.
English: They recommended that Ultratard be given marketing authorisation.
Latvian: Komiteja ieteica izsniegt Ultratard reģistrācijas apliecību.
English: How does Ultratard work?
Latvian: Kā Ultratard darbojas?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ULTRATARD EPAR summary for the public
Latvian: ULTRATARD EPAR kopsavilkums plašākai sabiedrībai
English: Ultratard is supplied as 40 or 100 IU strengths in vials.
Latvian: Zāļu pudelītes satur 40 vai 100 SV Ultratard.
English: What benefit has Ultratard shown during the studies?
Latvian: Kāds ir Ultratard iedarbīgums šajos pētījumos?
English: How has Ultratard been studied?
Latvian: Kā noritēja Ultratard izpēte?
English: What is Ultratard?
Latvian: Kas ir Ultratard?
English: Ultratard is a replacement insulin which identical to the insulin made by the pancreas .The active ingredient of Ultratard, insulin human (rDNA), is produced by a method known as ‘recombinant technology'.
Latvian: Ultratard aktīvo sastāvdaļu - cilvēka insulīnu (rDNS) - iegūst, izmantojot tā dēvēto “rekombinanto tehnoloģiju”.
English: How is Ultratard used?
Latvian: Kā lieto Ultratard?
English: For the full description of the side effects reported with Ultratard, please see the Package Leaflet.
Latvian: Pilns Ultratard izraisīto blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
English: The European Commission issued a Decision on 22 September 2011.
Latvian: Eiropas Komisija pieņēma lēmumu 2011. gada 22. septembrī.
English: What is Canazole?
Latvian: Kas ir Canazole?
English: Why was Canazole reviewed?
Latvian: Kādēļ tika pārskatīta informācija par Canazole?
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 25 November 2010.
Latvian: Taču dalībvalstis nespēja vienoties, un Īrijas zāļu aģentūra nosūtīja lietu pārskatīšanai CHMP šķīrējtiesā 2010. gada 25. novembrī.
English: The marketing authorisation in Ireland should also be suspended.
Latvian: Jāaptur arī Īrijā izsniegtā reģistrācijas apliecība.
English: The company which recently marketed this product wanted the authorisation to be recognised in the United Kingdom (the ‘concerned Member State').
Latvian: Uzņēmums, kurš nesen bija laidis tirgū šīs zāles, vēlējās, lai šo reģistrāciju atzīst arī Apvienotajā Karalistē (“iesaistītajā dalībvalstī”).
English: Without ergosterol, the fungus is killed or prevented from spreading.
Latvian: Bez ergosterola sēnīte iet bojā vai nespēj izplatīties.
English: Pinewood Laboratories Ltd submitted Canazole for mutual recognition on the basis of the initial authorisation granted by Ireland on 8 December 2000.
Latvian: Pinewood Laboratories Ltd iesniedza Canazole lietu savstarpējās atzīšanas procedūrai, pamatojoties uz sākotnēji 2000. gada 8. decembrī Īrijā izsniegto reģistrācijas apliecību.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.
Latvian: Eiropas Zāļu aģentūra ir pabeigusi arbitrāžas procedūru, kuras pamatā bija nesaskaņas starp Eiropas Savienības (ES) dalībvalstīm par zāļu Canazole reģistrāciju.
English: Canazole is a cream that contains the active substance clotrimazole (1%).
Latvian: Canazole ir krēms, kas satur aktīvo vielu klotrimazolu (1 %).
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the currently available data were not sufficient to show therapeutic equivalence with the reference medicine and that further data would need to be generated.
Latvian: Pamatojoties uz tolaik pieejamo datu novērtējumu un zinātniskajām apspriedēm Komitejā, CHMP secināja, ka konkrētajā brīdī pieejami dati nav pietiekami, lai pierādītu terapeitisko līdzvērtību ar atsauces zālēm un ka būtu jāiegūst papildu informācija.
English: In addition, the Committee has also recommended that the marketing authorisation for Canazole in Ireland be suspended until further studies are done.
Latvian: Komiteja ieteica arī apturēt Īrijā izsniegtās Canazole reģistrācijas apliecības darbību, kamēr nav veikti papildu pētījumi.
English: EMA/206825/2011 Rev.1 EMEA/H/A-29/1286
Latvian: EMEA/H/A-29/1286
English: Questions and answers on Canazole (clotrimazole cream 1%) EMA/837098/2011
Latvian: Jautājumi un atbildes par Canazole (1 % klotrimazola krēmu) EMA/206825/2011
English: The grounds for the referral were that the United Kingdom did not agree that Canazole cream and Canesten cream are similar enough to have therapeutic equivalence.
Latvian: Pārskatīšanas procedūras uzsākšanas pamatā bija fakts, ka Apvienotā Karaliste nepiekrita, ka Canazole krēms un Canesten krēms ir pietiekami līdzīgi, lai būtu terapeitiski līdzvērtīgi.
English: Canazole is a generic medicine based on a ‘reference medicine', Canesten, which is authorised in the United Kingdom.
Latvian: Canazole ir ģenēriskas zāles, kas izgatavotas, izmantojot “atsauces zāles” Canesten, kas reģistrētas Apvienotajā Karalistē.
English: It is used to treat skin infections caused by fungi, such as thrush, ringworm or athlete's foot.
Latvian: To lieto, lai ārstētu sēnīšu izraisītas ādas infekcijas, piemēram, kandidozi, cirpējēdi vai atlēta pēdu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Canazole do not outweigh its risks, and the marketing authorisation granted in Ireland cannot be recognised in other Member States of the EU.
Latvian: Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka Canazole sniegtie ieguvumi neattaisno to izraisīto risku un ka Īrijā izsniegto reģistrācijas apliecību nevar atzīt citās Eiropas Savienības dalībvalstīs.
English: The active substance in Canazole, clotrimazole, is an antifungal medicine that belongs to the group called triazoles.
Latvian: Canazole aktīvā viela klotrimazols ir pretsēnīšu līdzeklis, kas pieder triazolu grupai.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Latvian: Ergosterols ir nozīmīga sēnītes šūnas sienas daļa.
English: The CHMP therefore concluded that the benefits of Canazole do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member State.
Latvian: Tādēļ CHMP secināja, ka Canazole sniegtie ieguvumi neattaisno šo zāļu izraisīto risku un ka iesaistītajā dalībvalstī nedrīkst izsniegt reģistrācijas apliecību.
English: Questions and answers on Canazole (clotrimazole cream
Latvian: Jautājumi un atbildes par Canazole (1 % klotrimazola krēmu)
English: Ref.: EMEA/528144/2009 EMEA/H/C/535
Latvian: Atsauces dok.: EMEA/528144/2009 EMEA/H/C/535
English: The marketing authorisation was renewed on 13 October 2009.
Latvian: Reģistrācijas apliecību atjaunoja 2009. gada 13. oktobrī.
English: It is available as capsules (blue: 25 mg; orange: 50 mg).
Latvian: Tās ir pieejamas kā kapsulas (zilas: 25 mg; oranžas: 50 mg).
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 1884 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Latvian: (44-20) 74 18 84 00 Fax (44-20) 74 1884 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: Wilzin should be taken on an empty stomach, at least one hour before or two to three hours after meals.
Latvian: Wilzin ir jāieņem tukšā dūšā vismaz vienu stundu vai divas līdz trīs stundas pēc ēšanas.
English: The usual dose for adults is 50 mg three times a day.
Latvian: Parastā deva pieaugušajiem ir 50 mg trīs reizes dienā.
English: This causes a variety of effects, including liver disease and damage to the nervous system.
Latvian: Tas izraisa dažādas sekas, ieskaitot aknu slimību un nervu sistēmas bojājumus.
English: This results in copper building up in the body, first in the liver, then in other organs such as the eye and the brain.
Latvian: Tā rezultātā varš uzkrājas organismā, sākotnēji aknās, pēc tam citos orgānos, piemēram, acīs un smadzenēs.
English: Over time, the amount of copper in the body falls, improving the symptoms of the disease.
Latvian: Laika gaitā vara daudzums organismā samazinās, līdz ar to slimības simptomi uzlabojas.
English: Gastric irritation is usually worst with the first morning dose and disappears after the first few days of treatment.
Latvian: Kuņģa kairinājums parasti ir visvairāk izteikts pēc pirmās rīta devas un izzūd pēc dažām ārstēšanas dienām.
English: A reduced dose is used in children.
Latvian: Bērniem lieto zemāku devu.
English: The Committee for Medicinal products for Human Use (CHMP) noted that Wilson's disease is a fatal disease and the other medicines already being used for the disease can have severe side effects.
Latvian: Cilvēkiem paredzēto zāļu komiteja (CHMP) atzīmēja, ka Vilsona slimība ir nāvējoša slimība, bet citas zāles, kuras jau lieto šīs slimības ārstēšanai, var izraisīt smagas blakusparādības.
English: The main study involved 148 patients who were treated with Wilzin, but did not compare Wilzin with any other treatments.
Latvian: Pamatpētījumā iesaistīja 148 pacientus, kurus ārstēja ar Wilzin, taču Wilzin nesalīdzināja ar citām zālēm.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Wilzin to Orphan Europe SARL on 13 October 2004.
Latvian: Eiropas Komisija 2004. gada 13. oktobrī izsniedza Wilzin reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam Orphan Europe SARL.
English: Wilzin is a medicine that contains the active substance zinc.
Latvian: Wilzin ir zāles, kas satur aktīvo vielu cinku.