FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
Bulgarian: Havrix Adult за защита от хепатит A и Engerix-B за защита от хепатит B.
English: How does Twinrix Adult work?
Bulgarian: Как действа Twinrix Adult?
English: Why has Twinrix Adult been approved?
Bulgarian: Основания за одобряване на Twinrix Adult?
English: How is Twinrix Adult used?
Bulgarian: Как да използвате Twinrix Adult?
English: Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver).
Bulgarian: А и хепатит B (заболявания, засягащи черния дроб).
English: Canazole clotrimazole cream was authorised in Ireland on 8 December 2000 under Article 4.8 (a) (iii) of Directive 65/65/EEC.
Bulgarian: Canazole clotrimazole крем е разрешен в Ирландия на 8 декември 2000 г. съгласно член 4, параграф 8, буква а), точка iii) на Директива 65/65/ЕИО.
English: It is therefore considered that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Bulgarian: Поради това се счита, че данните, представени в подкрепа на заявлението, не съответстват на член 10 от Директива 2001/83/ЕО, както е изменена.
English: It was not possible to discuss variability between and within batches of the test and reference products as information on the necessary batches of each product was not provided.
Bulgarian: Не е възможно да се обсъди вариабилността между и вътре в партидите на изследвания и референтния продукт, тъй като не е предоставена информация за необходимите партиди на всеки продукт.
English: The totality of data submitted does not support the conclusion that the product is therapeutically equivalent.
Bulgarian: Съвкупността от представените данни не подкрепя заключението, че продуктът е терапевтично еквивалентен.
English: In addition, the CHMP considered that the preservative efficacy test lacked the methodological details which would allow a correct interpretation.
Bulgarian: В допълнение CHMP счита, че в изследването за ефикасност на консерванта липсват методологически подробности, които да позволят правилно тълкуване.
English: At the time of the initial authorisation, the need for therapeutic equivalence studies was waived based on quality data demonstrating that the proposed formulation was similar to the reference product with respect to formulation (except the benzyl alcohol concentration), pH and viscosity of the cream, globule size of the dispersed oil phase and size of the active substance present as particles.
Bulgarian: Към момента на първоначалното разрешение необходимостта от проучвания за терапевтична еквивалентност е отменена въз основа на данните за качеството, доказващи че предложената формулировка е аналогична на референтния продукт по отношение на състава (с изключение на концентрацията на бензиловия алкохол), рН и вискозитета на крема, размера на капката на диспергираната маслена фаза и големината на активното вещество, присъстващо под формата на частици.
English: Key pharmaceutical parameters, such as the dissolution of drug substance in the oily phase were not appropriately validated.
Bulgarian: Ключови фармацевтични параметри, като например разтваряне на лекарственото вещество в маслената фаза, не са подходящо потвърдени.
English: The CHMP noted that inconsistent data were provided regarding the state of the drug substance in the drug product and critical quality attributes were not satisfactorily addressed.
Bulgarian: СНМР отбелязва, че са предоставени непоследователни данни по отношение на състоянието на лекарственото вещество в лекарствения продукт, а критичните качествени характеристики не са били засегнати в задоволителна степен.
English: Comparative in vitro microbial tests to investigate the antimicrobial nature of the drug product were not provided.
Bulgarian: Сравнителни in vitro микробни тестове за изследване на антимикробната същност на лекарствения продукт не са били предоставени.
English: Canazole Clotrimazole Cream 1% w/w is an anti-fungal agent indicated for the treatment of superficial fungal skin and mucous membrane infections, such as candidiasis, dermatophytoses and commensal yeast infections.
Bulgarian: Canazole Clotrimazole крем 1 % т/т е противогъбичен агент, показан за лечение на повърхностни гъбични инфекции на кожата и лигавичните мембрани, като кандидоза, дерматофитози и инфекции, причинени от дрожди, под формата на коменсална флора.
English: Differences in droplets size and their possible effect in tissue penetration were not explained.
Bulgarian: Различията в големината на капката и техният възможен ефект, свързан с проникване в тъканите, не са изяснени.
English: The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and, in these circumstances, the marketing of the product constitutes a risk to public health.
Bulgarian: Комитетът счита, че не е възможно, въз основа на подадените в подкрепа на това заявление данни, да се докаже положително съотношение полза/риск за продукта и при тези обстоятелства пускането на пазара на продукта представлява риск за общественото здраве.
English: The application was submitted in the concerned member state (UK) under the mutual recognition procedure.
Bulgarian: (Обединеното кралство) по процедурата за взаимно признаване.
English: The comparative quality data provided and the preservative efficacy test were, therefore, not considered sufficient to justify a waiver of the need to demonstrate therapeutic equivalence by clinical studies or other validated model, and these were therefore deemed necessary in this case to prove equivalence.
Bulgarian: Предоставените сравнителни данни за качеството и изследването за ефикасност на консерванта, следователно, не са били счетени за достатъчно основание за отмяна на необходимостта да се докаже терапевтична еквивалентност от клинични проучвания или друг утвърден модел, а в този случай са били необходими, за да се докаже еквивалентност.
English: However, the need for a therapeutic equivalence study or other validated model for the formulation to prove equivalence was considered essential by the concerned member state and the matter was referred to the CHMP.
Bulgarian: Въпреки това, заинтересованата държава-членка е сметнала, че необходимостта от проучване за терапевтична еквивалентност на състава или от друг утвърден модел, който да докаже еквивалентността на препарата, е от съществено значение и CHMP е сезиран по въпроса.
English: An appropriate skin permeation or similar in vitro studies should have been performed to investigate this matter.
Bulgarian: За да се проучи този въпрос, е трябвало да бъдат извършени подходящи изследвания за кожна инфилтрация или други подобни in vitro проучвания.
English: The CHMP considered the comparative quality data and a preservative efficacy test (in vitro) to demonstrate comparable anti-fungal activity provided.
Bulgarian: За да докаже сравнима противогъбична активност, СНМР разглежда сравнителните данни за качеството и изследване за ефикасност на консерванта (in vitro).
English: The proposals are acceptable with some improvements.
Bulgarian: Forslagene er acceptable med nogle forbedringer.
English: You may need to read it again.
Bulgarian: Du kan få brug for at læse den igen.
English: Member State EU/EEA
Bulgarian: Medlemsland EU/EEA
English: {Name and address} {Tel} {fax} {e-mail}
Bulgarian: {Navn og adresse} {Tel} {fax} {e-mail}
English: However the effect of multiple doses is not known.
Bulgarian: Dog kendes ikke effekten af flere doser.
English: There are differences, however, in the results obtained from various trials (HOPE, EUROPA, PEACE, and PART 2).
Bulgarian: Der er imidlertid forskelle i resultaterne fra de forskellige undersøgelser (HOPE, EUROPA, PEACE og PART 2).
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Bulgarian: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
English: Both subpopulations were prospectively stratified.
Bulgarian: Begge subpopulationer blev lagdelt prospektivt.
English: 1000 Ljubljana Slovenia
Bulgarian: 1000 Ljubljana Slovenien
English: Ethnic differences
Bulgarian: Etniske forskelle
English: Placebo relative risk (95% confidence interval)
Bulgarian: Placebo relativ risiko (95% konfidensinterval)
English: Do not pass it on to others.
Bulgarian: Lad derfor være med at give TRITACE til andre.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Bulgarian: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: It must not be chewed or crushed.
Bulgarian: Må ikke tygges eller knuses.
English: How much to take
Bulgarian: Hvor meget må jeg tage:
English: It is recommended that TRITACE is taken each day at the same time of the day.
Bulgarian: Det anbefales, at TRITACE tages hver dag på samme tidspunkt.
English: All patients n=4,645
Bulgarian: Alle patienter n=4.645
English: It also reduced neuroendocrine activation.
Bulgarian: Det øgede også neuroendokrin aktivering.
English: • If your blood pressure is abnormally low or unstable.
Bulgarian: Hvis dit blodtryk er unormalt lavt eller ustabilt.
English: Caution is therefore recommended since these patients may be volume and/or salt depleted.
Bulgarian: Forsigtighed anbefales derfor, da disse patienter kan være udtømte for væske og/eller salt.
English: Emergency therapy should be instituted promptly.
Bulgarian: Nødbehandling bør iværksættes hurtigt.
English: 167 14 Bromma Sweden
Bulgarian: 167 14 Bromma Sverige
English: Critical Evaluation
Bulgarian: Kritisk vurdering
English: It may harm them even if their symptoms are the same as yours.
Bulgarian: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Bulgarian: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Tremor, balance disorder
Bulgarian: Tremor, balanceforstyrrelser
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Bulgarian: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse.
English: Your doctor will need to make this assessment.
Bulgarian: Dette skal din læge vurdere.
English: Rats, dogs and monkeys tolerated daily doses of 2, 2.5 and 8 mg/kg/d respectively without harmful effects.
Bulgarian: Rotter, hunde og aber tolererede daglige doser på 2, 2,5 og 8 mg/kg/dag respektivt, uden skadelige virkninger.
English: Tell your doctor immediately if you experience:
Bulgarian: Kontakt straks lægen hvis du oplever:
English: • Making it easier for your heart to pump blood around your body.
Bulgarian: Gør det lettere for dit hjerte at pumpe blodet rundt i din krop
English: You may need to stop your TRITACE treatment one day beforehand; ask your doctor for advice
Bulgarian: Det kan være nødvendigt at stoppe TRITACE behandlingen en dag i forvejen; spørg din læge
English: This means an absolute mortality reduction of 5.7 % and a relative risk reduction of 27 % (95 % CI
Bulgarian: Det betyder en absolut reduktion i mortalitet på 5,7% og en relativ risikoreduktion på 27 % (95 % KI [11-40 %]
English: Blood glucose monitoring is recommended.
Bulgarian: Der anbefales monitorering af blodglukose.
English: Hospitalisation for heart failure 3.2 Complications related to diabetes 6.4
Bulgarian: Indlæggelse for hjerteinsufficiens 3.2 Diabetesrelaterede komplikationer 6.4
English: 08019 Barcelona Spain
Bulgarian: 08019 Barcelona Spanien
English: NO-1325 Lysaker Norway
Bulgarian: NO-1325 Lysaker Norge
English: • Medicines to stop the rejection of organs after a transplant such as ciclosporin
Bulgarian: Medicin der stopper afstødning af organer efter en transplantation såsom ciklosporin
English: The main areas for harmonisation were: the sections 4.1, 4.2, 4.3, 4.4 and 4.6 of the summary of product information (SPC).
Bulgarian: Følgende hovedområder skulle harmoniseres: punkterne 4.1, 4.2, 4.3, 4.4 og 4.6 i produktresuméet.
English: Usually the dose is administered once daily.
Bulgarian: Denne dosis administreres sædvanligvis en gang daglig.
English: If you are not sure, talk to your doctor before taking TRITACE.
Bulgarian: Hvis du er usikker, så tal med din læge, inden du anvender TRITACE.
English: This change of the text is to ensure it doesn't suggest an immediate artificial abortion, which is not justified by the clinical experiences collected till now.
Bulgarian: Denne ændring af teksten skal sikre, at der ikke tilrådes omgående, provokeret abort, hvilket der ikke er grundlag for i de kliniske erfaringer, der er indsamlet
English: However the company challenged this view and proposed a contraindication through out pregnancy, based on data from the ramipril pregnancy register.
Bulgarian: Virksomheden imødegik imidlertid dette synspunkt og foreslog en kontraindikation under hele graviditeten baseret på data fra graviditetsregistret for ramipril.
English: It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia.
Bulgarian: Det anbefales, at monitorere det hvide blodlegemetal for at kunne detektere muligt leukopeni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TRITACE AND ASSOCIATED NAMES (SEE ANNEX I)
Bulgarian: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF TRITACE OG TILKNYTTEDE NAVNE (SE BILAG I)
English: This could be a sign of a severe allergic reaction to TRITACE
Bulgarian: Dette kan være tegn på en alvorlig allergisk reaktion mod TRITACE.
English: After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
Bulgarian: Efter første dosis eller efterfølgende stigninger i dosis frarådes det, at føre motorkøretøjer, eller betjene maskiner i adskillige timer.
English: Your doctor will reduce the initial dose and adjust your treatment more slowly.
Bulgarian: Lægen vil nedsætte startdosis og tilpasse behandlingen langsomt
English: Clinical efficacy and safety
Bulgarian: Klinisk effekt og sikkerhed
English: In most countries the dose is doubled every 1-2 weeks, except in Hungary where the duration is 2-3 weeks.
Bulgarian: I de fleste lande fordobles dosis hver uge eller hver anden uge med undtagelse af Ungarn, hvor varigheden er 2-3 uger.
English: Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Bulgarian: Hyperkaliæmi kan opstå, derfor kræves tæt monitorering af serumkalium.
English: In patients with diabetes and microalbuminuria:
Bulgarian: Hos patienter med diabetes og microalbuminuri:
English: The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9 % and in the placebo treated patients was 22.6 %.
Bulgarian: Studiet viste, at efter en gennemsnitlig opfølgningstid på 15 måneder, var dødeligheden hos ramiprilbehandlede patienter 16,9 % og hos placebobehandlede patienter var den 22,6 %.
English: A number of areas of disharmony in the product information for Tritace have been evaluated by the CHMP and a revised product information was adopted.
Bulgarian: CHMP har vurderet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for Tritace, og en revideret produktinformation blev vedtaget.
English: • Sleep problems
Bulgarian: • Søvnproblemer
English: A temporary discontinuation of TRITACE should be considered prior to desensitization.
Bulgarian: En midlertidig seponering af TRITACe bør overvejes før desensibilisering.
English: AstraZeneca Sverige SE-151 85 Södertälje Sweden
Bulgarian: AstraZeneca Sverige SE-151 85 Södertälje Sverige
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Bulgarian: BILAG I LISTE OVER NAVNE, LÆGEMIDDELFORMER, STYRKER PÅ LÆGEMIDLERNE, ADMINISTRATIONSVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSLANDENE
English: Tritace was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended, as the above-mentioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Bulgarian: Tritace stod på den liste over produkter, for hvilke produktresuméerne skulle harmoniseres, som CMD(h) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF med senere ændringer, da produktresuméet for ovennævnte lægemiddel ikke er det samme i EU-medlemsstaterne, Island og Norge.
English: Like all medicines, TRITACE can cause side effects, although not everybody gets them.
Bulgarian: TRITACE kan som al anden medicin give bivirkninger, ikke alle får bivirkninger.
English: Your lithium amount will need to be closely checked by your doctor.
Bulgarian: Dit litiumindhold skal derfor overvåges nøje af din læge.
English: • Decreasing your body's production of substances that could raise your blood pressure
Bulgarian: Mindske kroppens produktion af stoffer der gør at man får forhøjet blodtryk
English: - Patients at risk of cardiac or cerebral ischemia in case of acute hypotension The initial phase of treatment requires special medical supervision.
Bulgarian: -Patienter med risiko for kardiel- eller cerebral iskæmi i tilfælde af akut hypotension Opstartsfasen af behandlingen kræver særligt medicinsk opsyn.
English: LABELLING
Bulgarian: ETIKETTERING
English: AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italy
Bulgarian: AstraZeneca S.p.A Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) Italien
English: The peak effect of a single dose is usually reached 3 to 6 hours after oral administration.
Bulgarian: Maksimal effekt af en enkelt dosis nås almindeligvis fra 3 til 6 timer efter oral administration.
English: In case of angioedema, TRITACE must be discontinued.
Bulgarian: I tilfælde af angioødem skal TRITACE seponeres.
English: These patients presented with abdominal pain (with or without nausea or vomiting).
Bulgarian: Disse patienter meddelte om mavesmerter (med eller uden kvalme og opkastning).
English: Indications of plasma electrolyte shifts and changes in blood picture have been found in the 3 species.
Bulgarian: tegn på plasmaelektrolytskift og ændringer i blodbilledet i disse 3 arter.
English: Extensive mutagenicity testing using several test systems has yielded no indication that ramipril possesses mutagenic or genotoxic properties.
Bulgarian: Omfattende mutagenicitetstestning med flere testsystemer har ikke givet nogen indikation af, at ramipril besidder mutagene eller genotoksiske egenskaber.
English: A reduced initial dose of 1.25 mg ramipril should be considered.
Bulgarian: En reduceret startdosis på 1,25 mg ramipril bør overvejes.
English: • An increased number of certain white blood cells (eosinophilia) found during a blood test
Bulgarian: Øget antal af visse hvide blodlegemer (eosinophilia) set i blodprøver
English: Administration of ramipril causes a marked reduction in peripheral arterial resistance.
Bulgarian: Administration af ramipril forårsager en udtalt reduktion i den perifere arterielle modstand.
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Bulgarian: NV AstraZeneca SA Egide Van Ophemstraat 110
English: Secondary endpoints Death from any cause Need for Revascularisation Hospitalisation for unstable angina
Bulgarian: Sekundære endepunkter Død af vilkårlig årsag Behov for revaskularisering Indlæggelse for ustabil angina
English: Antihypertensive properties:
Bulgarian: Antihypertensive egenskaber:
English: Anaphylactic reactions during desensitization
Bulgarian: Anafylaktiske reaktioner under desensibilisering
English: The ramipril treatment was started 3 to 10 days after the acute myocardial infarction.
Bulgarian: Ramiprilbehandlingen blev påbegyndt 3-10 dage efter akut myokardieinfarkt.
English: Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
Bulgarian: Generelt anbefales det, at udbedre dehydrering, hypovolæmi eller saltmangel før behandlingen påbegyndes (dog bør sådanne korrigerende handlinger nøje vurderes mod risikoen for volumenoverbelastning hos patienter med hjerteinsufficiens).
English: • If you are having dialysis or any other type of blood filtration.
Bulgarian: Hvis du er i dialysebehandling eller andre typer filtrering af blodet.
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Bulgarian: Epidemiologiske undersøgelser af risikoen for teratogenitet ved behandling med ACE-hæmmere under graviditetens første trimester er inkonklusive, men en lille forøget risiko kan ikke udelukkes.
English: United Kingdom HOECHST MARION ROUSSEL LTD.
Bulgarian: HOECHST MARION ROUSSEL LTD.
English: Generally, there are no major changes in renal plasma flow and glomerular filtration rate.
Bulgarian: ingen større ændring i det renale plasma flow og den glomerulære filtrationsrate.
English: This could be a sign of pancreatitis (inflammation of the pancreas).
Bulgarian: Dette kan være tegn på pancreatitis (betændelse i bugspytkirtlen).
English: • Medicines for cancer (chemotherapy)
Bulgarian: Medicin mod kræft (kemoterapi)
English: Monitoring of renal function
Bulgarian: Monitorering af nyrefunktionen
English: Hypotension may occur following initiation of therapy with TRITACE; this is more likely in patients who are being treated concurrently with diuretics.
Bulgarian: Hypotension kan forekomme efter påbegyndelse af behandling med TRITACE; Dette er mere sandsynligt hos patienter der samtidigt behandles med diuretika.
English: Always take TRITACE exactly as your doctor has told you.
Bulgarian: Tag altid TRITACE nøjagtigt efter lægens anvisning.
English: Contra-indicated combinations
Bulgarian: Kontraindicerede kombinationer
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Bulgarian: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: Uncommon Rare
Bulgarian: Ikke almindelig Sjælden
English: • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)
Bulgarian: • Til nedsættelse af risikoen eller forsinke forværring af nyresygdom (hvedenten du har diabetes eller ej)
English: If this happens, do not drive or use any tools or machines.
Bulgarian: Hvis dette sker for dig, bør du ikke køre eller bruge visse former for maskiner.
English: Distribution The serum protein binding of ramipril is about 73 % and that of ramiprilat about 56 %.
Bulgarian: Distribution Serum proteinbindingen af ramipril er omkring 73 % og omkring 56 % for ramiprilat.
English: 56218 Mülheim-Kärlich Germany
Bulgarian: 56218 Mülheim-Kärlich Tyskland
English: Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion.
Bulgarian: Da angiotensin II også stimulerer frigørelsen af aldosteron, forårsager ramiprilat en nedsættelse i aldosteron udskillelsen.
English: This leaflet does not contain all the information about your medicine.
Bulgarian: ikke al information om din medicin.
English: Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment.
Bulgarian: Nyrefunktionen bør fastslås før og under behandlingen, og dosis bør justeres i de første uger af behandlingen.
English: In patients with diabetes and at least one cardiovascular risk
Bulgarian: Hos patienter med diabetes og mindst én kardiovaskulær risikofaktor