FrancophonIA/ELRC3.0 huggingface dataset:
English: WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 France
Bulgarian: WINTHROP MEDICAMENTS 1-13 Boulevard Romain Rolland F-75159 Paris, Cedex 14 Frankrig
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Bulgarian: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: • If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)
Bulgarian: Skal i behandling for bi eller hvepsestik for at nedsætte en allergisk reaktion (desensibilisering)
English: The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least ≥ 55 years old (with no upper limit of age), with a majority of type 2 diabetes (and at least another CV risk factor), normotensive or hypertensive.
Bulgarian: til det eksisterende medicinske regime versus placebo hos 3.577 patienter, der var mindst 55 år gamle (ingen øvre aldersgrænse), med overvægt af type 2 diabetes (og mindst én yderligere CV risikofaktor), normotensiv eller hypertensive.
English: • Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
Bulgarian: Kløe og unormale hud tilstande såsom følelsesløshed, prikkende eller brændende fornemmelse i huden (parastesi)
English: Triatec Ramipril sanofi-aventis
Bulgarian: Ramipril sanofi-aventis
English: Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting
Bulgarian: Mave-tarmkanalen Gastrointestinal inflammation, fordøjelsesforstyrrelser, ubehag i maven, dyspepsi, diarre, kvalme, opkastning.
English: France:
Bulgarian: Frankrig:
English: • The usual dose is 5 mg or 10 mg once daily.
Bulgarian: Den almindelige dosis er 5 mg eller 10 mg én gang dagligt
English: PHARMACOLOGICAL PROPERTIES
Bulgarian: FARMAKOLOGISKE EGENSKABER
English: Treatment of heart failure
Bulgarian: Behandling af hjertesvigt
English: Greece
Bulgarian: Grækenland
English: Tablet Hard Capsule
Bulgarian: Tablet Kapsel, hård
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Bulgarian: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: The current indication of ramipril in hypertension differs among the EU countries.
Bulgarian: Den aktuelle indikation for ramipril ved hypertension er
English: Headache, dizziness
Bulgarian: Hovedpine, svimmelhed
English: Slovak Republic SANOFI-AVENTIS SLOVAKIA s.r.o.
Bulgarian: SANOFI-AVENTIS SLOVAKIA s.r.o.
English: The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i.e. mean urinary protein excretion > 1 and < 3 g/24 h) or severe proteinuria (≥ 3 g/24 h) due to chronic non-diabetic nephropathy.
Bulgarian: Et randomiseret, dobbeltblindet parallelgruppe-, placebokontrolleret multicenterstudie, REIN-studiet, havde som mål at vurdere effekten af behandling med ramipril på graden af forværring i glomerulærfunktionsraten (GFR) hos 352 normotensive eller hypertensive patienter (18-70 år), der led af mild til svær proteinuri (mild:
English: It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg TRITACE once daily.
Bulgarian: to ugers behandling og - efter yderligere to til tre uger - at forøge den op til den ønskede vedligeholdelsesdosis på 10 mg TRITACE en gang daglig.
English: SPECIAL STORAGE CONDITIONS [To be completed nationally]
Bulgarian: SÆRLIGE OPBEVARINGSBETINGELSER [Udfyldes nationalt]
English: - Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1) - History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs) - Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5) - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney - 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6) - Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Bulgarian: - ”Overfølsomhed over for ramipril, et eller flere af hjælpestofferne eller enhver anden ACE-hæmmer (se afsnit 6.1) - Tidligere hereditært eller idiopatisk angioødem - Ekstrakorporale behandlinger, som medfører kontakt af blod med negativt ladede overflader (se afsnit 4.5) - Signifikant bilateral nyrearteriestenose eller nyrearteriestenose i en enkelt fungerende nyre - Graviditet i 2.
English: Czech Republic:
Bulgarian: Tjekkiet:
English: The CHMP agreed the following: “The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Bulgarian: til 4 uger forekommer relevant baseret på individuel variabilitet. CHMP vedtog følgende: "Dosis fastlægges efter individuel vurdering ud fra patientprofilen (se afsnit 4.4) og blodtrykskontrol.
English: TRITACE can be used:
Bulgarian: Du kan anvende TRITACE:
English: - Treatment of symptomatic heart failure.
Bulgarian: ”Behandling af symptomatisk hjerteinsufficiens”.
English: Common
Bulgarian: Almindelig
English: Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8).
Bulgarian: Intestinalt angioødem er blevet rapporteret hos patienter i behandling med ACE-hæmmere inklusive TRITACE (se pkt.
English: Belgium:
Bulgarian: Belgien:
English: And finally, for patients with non diabetic nephropathy macroproteinuria ≥3gm/day, the recommended initial dose is 1.25 mg of Tritace once daily.
Bulgarian: Endelig er den anbefalede startdosis til patienter med ikke-diabetisk nefropati med makroproteinuri ≥3g/dag 1,25 mg Tritace én gang dagligt.
English: • Red, itchy, swollen or watery eyes
Bulgarian: Røde, kløende, hævede, fugtige øjne
English: The MAH calls on a high level of evidence for ACE-Is administered in the first 24 hours following acute myocardial infarction (MI) in international recommendations, to justify initiating therapy with 24 hours of MI at the lowest dose of 1.25 mg daily (that used as first dose in the heart failure indication), provided that stable haemodynamic conditions are met and the regulatory precedent with lisinopril wording.
Bulgarian: inden for 24 timer efter myokardieinfarkt med den laveste dosis på 1,25 mg dagligt (som anvendes som første dosis ved hjerteinsufficiens-indikationen), forudsat at patienten er hæmodynamisk stabil og det kontrolmæssige fortilfælde med ordlyden for lisinopril.
English: United Kingdom AVENTIS PHARMA LTD 50 Kings Hill Avenue
Bulgarian: AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Bulgarian: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day.
Bulgarian: Hvis startdosis på 2,5 mg ikke tolereres, bør der gives 1,25 mg to gange daglig i to dage, før dosis øges til 2,5 mg og 5 mg to gange daglig.
English: Sweden:
Bulgarian: Sverige:
English: Austria:
Bulgarian: Østrig:
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Bulgarian: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn}
English: • Procainamide (for heart rhythm problems).
Bulgarian: Procainamid (mod problemer med hjerterytmen)
English: Germany:
Bulgarian: Tyskland:
English: Cough has been reported with the use of ACE inhibitors.
Bulgarian: - Der er rapporteret hoste ved brug af ACE-hæmmere.
English: 65926 Frankfurt am Main Germany
Bulgarian: 65926 Frankfurt am Main Tyskland
English: If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
Bulgarian: Hvis dosis ikke kan øges til 2,5 mg to gange daglig bør behandlingen seponeres.
English: • Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin.
Bulgarian: Lettere tendens til blå mærker, længere blødningsperioder, tegn på blødninger (f.eks. blødning fra tandkødet), lilla mærker på huden, lettere tendens til at få infektioner, halsbetændelse, feber, træthedsfornemmelse, svimmel eller bleghed.
English: Your doctor will need to check your blood pressure.
Bulgarian: tage dit blodtryk.
English: Blood potassium increased
Bulgarian: Øget blodnatrium
English: Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).
Bulgarian: Akut leverunsufficiens eller cytolitisk hepatitis (i meget få tilfælde med dødelig udgang)
English: EXPIRY DATE
Bulgarian: UDLØBSDATO
English: Cyprus: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
Bulgarian: Cypern: Triatec 2.5 mg δισκία, Triatec 5 mg δισκία, Triatec 10 mg δισκία
English: Netherlands:
Bulgarian: Nederlandene:
English: The CHMP adopted the following: “Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor”.
Bulgarian: og mortalitet hos patienter med: i) manifest aterotrombotisk kardiovaskulær sygdom (tidligere koronar hjertesygdom eller slagtilfælde eller perifer vaskulær sygdom), eller ii) diabetes med mindst én kardiovaskulær risikofaktor”.
English: Immune system disorders
Bulgarian: Immunsystemet
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Tritace and associated names (see Annex I).
Bulgarian: Produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Tritace og tilknyttede navne (se bilag I).
English: • Blood tests showing less sodium than usual in your blood
Bulgarian: Blodprøveresultater der viser lavere indhold af natrium end normalt
English: • Blotches on your skin and cold extremities
Bulgarian: Hudpletter og kolde hænder og fødder
English: Based on urinary recovery, the extent of absorption is at least 56 % and is not significantly influenced by the presence of food in the gastrointestinal tract.
Bulgarian: Absorptionen er, baseret på urinopsamling, mindst 56 % og er
English: Hyperkalaemia
Bulgarian: Hyperkaliæmi
English: - Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
Bulgarian: Nedsættelse af mortalitet af den akutte fase af myokardieinfarkt hos patienter med kliniske tegn på hjerteinsufficiens, når behandlingen påbegyndes > 48 timer efter akut myokardieinfarkt”.
English: • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)
Bulgarian: ikke kan pumpe tilstrækkeligt blod rundt i din krop (hjertesvigt) Til forebyggelse efter blodprop
English: Guildford Surrey GU1 4YS UK
Bulgarian: One Onslow Street Guildford Surrey GU1 4YS UK
English: Psychiatric disorders
Bulgarian: Psykiske forstyrrelser
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Bulgarian: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt]
English: Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
Bulgarian: sig og reagere, og udgør derfor en risiko i situationer hvor disse evner er særligt vigtige (f.eks.ved betjening af motorkøretøj eller maskiner).
English: Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
Bulgarian: slagtilfælde eller perifer vaskulær sygdom i anamnesen), eller diabetes mellitus med mindst én ekstra risikofaktor (dokumenteret mikroalbuminuri, hypertension, forhøjet totalkolesterolniveau, lavt HDL kolesterolniveau eller rygning).
English: Italy:
Bulgarian: Italien:
English: Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II).
Bulgarian: Ramiprilat, den aktive metabolit fra prodrug ramipril, hæmmer enzymet dipeptidylcarboxypeptidase I (som er
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Bulgarian: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Bulgarian: Det er kendt, at eksponering for ACE-hæmmere/Angiotensin II Receptor Antagonister i graviditetens andet og tredje trimester forårsager human føtotoksicitet (nedsat nyrefunktion, oligohydramnion, forsinket ossifikation af kraniet) og neonatal toksicitet (nyreinsufficiens, hypotension, hyperkaliæmi) (se også pkt. 5.3).
English: [See Annex I - To be completed nationally]
Bulgarian: [Se bilag I - Udfyldes nationalt]
English: • Blood tests showing changes in the way your liver, pancreas or kidneys are working.
Bulgarian: Blodprøveresultater der viser ændring i lever, bugspytkirtel og nyrernes funktion
English: Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
Bulgarian: Angioødem er blevet rapporteret hos patienter i behandling med ACE-hæmmere inklusive ramipril (se pkt.
English: • If you have heart, liver or kidney problems
Bulgarian: Har dårligt hjerte, lever eller nyrer
English: Angioedema
Bulgarian: Angioødem
English: Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Bulgarian: til at genskabe hæmodynamisk stabilitet, såsom administration af alpha 1 adrenerge agonister eller angiotensin II (angiotensinamid).
English: Nervous system disorders
Bulgarian: Nervesystemet
English: • Swollen mouth
Bulgarian: Aftuøs stomatit mund.
English: - Treatment of renal disease: o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day (see section 5.1).
Bulgarian: − Behandling af nyrelidelser: o Begyndende glomerulær diabetisk nefropati defineret ved tilstedeværelsen af mikroalbuminuri o Manifest glomerulær diabetisk nefropati defineret ved makroproteinuri hos patienter med mindst én kardiovaskulær risikofaktor (se pkt.
English: United Kingdom
Bulgarian: Storbritannien/UK
English: The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/min/year; 23.1 % of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs. 45.5 % in the placebo group (p = 0.02).
Bulgarian: % af patienterne i ramiprilgruppen opnåede det kombinerede sekundære endepunkt, fordobling af baseline serumkreatininkoncentration og/eller end-stage nyresygdom (ESRD) (behov for dialyse eller nyretransplantation) vs. 45,5 % i placebogruppen (p=
English: ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Bulgarian: ACE-hæmmerinduceret hoste skal betragtes som en differentialdiagnose til hoste.
English: Spain:
Bulgarian: Spanien:
English: Symptomatic Heart failure
Bulgarian: Symptomatisk hjerteinsufficiens
English: • Breast enlargement in men
Bulgarian: Forstørrelse af brysterne hos mænd
English: TRITACE should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.
Bulgarian: til to uger op til en maksimal dosis på 10 mg. To daglige administrationer er at foretrække.
English: Exfoliative dermatitis, urticaria, onycholysis,
Bulgarian: Eksfoliativ dermatit, urticaria, nedbrydning af negle
English: Greece: Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
Bulgarian: Grækenland: Triatec 1.25 mg δισκία, Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
English: This is so the doctor knows what you have taken.
Bulgarian: Medbring pakningen og denne indlægsseddel så lægen kan se hvad du har taget.
English: Vesdil 1,25 mg Kapseln Vesdil 2,5 mg kapseln Vesdil 5 mg Kapseln
Bulgarian: Vesdil 2,5 mg kapseln Vesdil 5 mg Kapseln
English: The HOPE study: Main results Ramipril
Bulgarian: Hovedresultater Ramipril
English: • If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis)
Bulgarian: til nyrerne er nedsat (renal arterie stenose)
English: Netherlands
Bulgarian: Holland
English: Jaundice cholestatic, hepatocellular damage
Bulgarian: Kolestatisk gulsot, beskadigelse af leverceller
English: • Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke
Bulgarian: Øget puls, hjertebanken (palpitations), brystsmerter, strammende fornemmelse i brystet eller mere alvorlige lidelser
English: The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
Bulgarian: Hvis du tidligere har haft en alvorlig overfølsomhedsreaktion der kaldes ”angioødem”. Symptomerne er kløe, nældefeber, røde pletter på hænderne, fødderne og på halsen hævelser af tungen, rundt om øjnene og læberne, besværligheder med at trække vejret og synkebesvær.
English: • Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs
Bulgarian: Smertestillende medicin (Nonsteroide antiinflammatoriske drugs (NSAID'er)
English: Respiratory, thoracic and mediastinal disorders
Bulgarian: Luftveje, thorax og mediastinum
English: The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/min/month, p = 0.038.
Bulgarian: i ramiprilgruppen) viste, at gennemsnitsraten hvormed GFR faldt var lavere i ramiprilgruppen, end i placebogruppen; -0,54 (0,66) vs.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Bulgarian: til råds, før du tager nogen form for medicin.
English: Hungary
Bulgarian: Ungarn
English: Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Bulgarian: Det har vist sig, at den antihypertensive effekt opretholdes under langtidsterapi på to år. Pludseligt ophør med ramipril giver ikke et hurtigt og excessivt tilbageslag med stigning i blodtryk
English: If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).
Bulgarian: til 3 dage før påbegyndelse af behandling med TRITACE (se pkt.
English: In this leaflet:
Bulgarian: i hjertet:
English: Hungary:
Bulgarian: Ungarn:
English: • Shortness of breath or a cough.
Bulgarian: Vejrtrækningsproblemer eller hoste.
English: Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema,
Bulgarian: Pankreatit (rapporter med fatalt udfald med ACEhæmmere er meget sjældent blevet indrapporteret), stigning i pankreasenzymer, tyndtarmsangioødem, øvre abdominalsmerter inklusive gastritis, forstoppelse, tør
English: reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).
Bulgarian: Alvorlige reaktioner på huden såsom hududslæt, sår i munden, forværring af eksisterende hudsygdomme, rødmen, forekomst af blistere på huden (såsom Stevens-Johnson syndrom, toksisk epidermisk nekrolyse eller erythema multiform)
English: If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Bulgarian: ikke er beskrevet i denne indlægsseddel, skal du kontakte din læge eller dit apotek.
English: MARKETING AUTHORISATION HOLDER
Bulgarian: Indehaver af markedsføringstilladelsen
English: Taking this medicine
Bulgarian: Brug af anden medicin
English: Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Bulgarian: i andet eller tredje trimester anbefales ultralydsscanning af fosterets nyre funktion og kranium. Børn, hvis mødre har taget ACE-hæmmere, bør observeres nøje for hypotension, oliguri og hyperkaliæmi (se punkt 4.3 og 4.4).
English: You may feel dizzy, while taking TRITACE.
Bulgarian: samtidig med at du anvender TRITACE kan du blive svimmel.
English: • Fever
Bulgarian: Feber
English: Starting dose In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.
Bulgarian: ”Hos patienter, som er stabiliserede med diuretikabehandling, er den anbefalede startdosis 1,25 mg dagligt.
English: P.O.
Bulgarian: A.
English: • If you miss a dose, take your normal dose when it is next due.
Bulgarian: tage den normale dosis næste gang Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Bulgarian: sagen var at harmonisere produktresuméerne, etiketteringen og indlægssedlen - produktresuméerne, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den
English: Tritace 2.5 mg comprimate, Tritace 5 mg comprimate, Tritace 10 mg comprimate Zenra 2.5 mg comprimate, Zenra 5 mg comprimate, Zenra 10 mg comprimate
Bulgarian: Zenra 2.5 mg comprimate, Zenra 5 mg comprimate, Zenra 10 mg comprimate
English: Arthralgia
Bulgarian: Artralgi
English: When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Bulgarian: skal behandling med ACE-hæmmere og AIIRA seponeres øjeblikkeligt, og der bør opstartes en alternativ behandling (se pkt.
English: SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Greece
Bulgarian: SANOFI-AVENTIS AEBE 348, Syngrou Av.
English: • Making your blood vessels relax and widen
Bulgarian: til at slappe af og udvide