FrancophonIA/ELRC3.0 huggingface dataset:
English: Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).
Bulgarian: Allopurinol, immunosuppressiva, kortikosteroider, procainamid, cytostatika og andre stoffer der kan ændre antallet af blodlegemer:
English: • During the last 6 months of pregnancy (see section below on “Pregnancy and breast-feeding”)
Bulgarian: Hvis du er gravid i anden og tredje trimester (se afsnittet nedenfor om graviditet og amning)
English: TRITACE is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3
Bulgarian: Du bør ikke anvende TRITACE i de første 12 uger af din graviditet, og efter den 13.
English: See also posology on diuretic treated patients above.
Bulgarian: til patienter i behandling med diuretika ovenfor.
English: If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Bulgarian: serumkalium anbefales hvis samtidig behandling med de ovenfor nævnte midler vurderes passende (se pkt.
English: Secondary prevention after acute myocardial infarction In all countries where the post myocardial infarction indication has been approved the initial recommended dose is 2.5 mg twice daily.
Bulgarian: I alle lande, hvor indikationen efter myokardieinfarkt er godkendt, er den anbefalede startdosis 2,5 mg to gange dagligt.
English: • The usual starting dose is 1.25 mg once daily.
Bulgarian: Den almindelige startdosis er 1,25 mg én gang dagligt
English: Common (affects less than 1 in 10 people)
Bulgarian: Almindelige bivirkninger (forekommer hos færre end 1 ud af 10 patienter)
English: Special populations
Bulgarian: Særlige patientgrupper
English: Denmark:
Bulgarian: Danmark:
English: The text agreed in the PhVWP of this warning doesn't encourage or propose the use of ACE inhibitors during the first trimester of the pregnancy on the contrary once the pregnancy is detected the prescriber has to stop the use of ACE inhibitors and to change if it is necessary for another antihypertensive agent as soon as possible.
Bulgarian: Den tekst, som er vedtaget i arbejdsgruppen vedrørende lægemiddelovervågning for denne advarsel, opmuntrer ikke til eller foreslår anvendelse af ACE-hæmmere under graviditetens første trimester.
English: Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Bulgarian: Det anbefales at fordoble dosis til 2,5 mg efter to uger, og siden
English: Treatment of high blood pressure
Bulgarian: Behandling efter blodprop
English: Triatec faible 1,25 mg, gélule Triatec 2.5 mg, gélule
Bulgarian: Triatec faible 1,25 mg, gélule Triatec 2.5 mg, gélule Triatec 5 mg, gélule
English: Rare (affects less than 1 in 1,000 people)
Bulgarian: Sjældne bivirkninger (forekommer hos færre end 1 ud af 1.000 patienter):
English: They may be affected by TRITACE:
Bulgarian: De kan nemlig øge virkningen af TRITACE:
English: Chest pain, fatigue
Bulgarian: Brystsmerter, udmattethed
English: The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks.
Bulgarian: Den antihypertensive virkning af en enkelt dosis varer sædvanligvis 24 timer. Den maksimale antihypertensive effekt af fortsat behandling med ramipril ses almindeligvis efter 3
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Bulgarian: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
English: PRECLINICAL SAFETY DATA
Bulgarian: 5.3 Prækliniske sikkerhedsdata
English: • Disturbed hearing and ringing in your ears
Bulgarian: Høreforstyrrelser og ringen for ørerne
English: Regarding the therapeutic indications for heart failure, the MAH proposed the wording: “Treatment of congestive heart failure”.
Bulgarian: Indehaveren af markedsføringstilladelsen har foreslået følgende ordlyd for de terapeutiske indikationer for hjerteinsufficiens:
English: CLINICAL PARTICULARS
Bulgarian: KLINISKE OPLYSNINGER
English: Ramipril - Zentiva 2.5mg Ramipril - Zentiva 5mg Ramipril - Zentiva 10mg
Bulgarian: - Zentiva 1.25mg Ramipril - Zentiva 2.5mg Ramipril - Zentiva 5mg Ramipril
English: The MAH proposed indication “Secondary prevention after MI in patients with heart failure” has been justified on the basis of the: Acute Infarction Ramipril Efficacy Study (AIRE).
Bulgarian: Indikationen “Sekundær profylakse efter myokardieinfarkt hos patienter med hjerteinsufficiens”, som indehaveren af markedsføringstilladelsen har foreslået, er berettiget på basis af:
English: Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
Bulgarian: Den aktive metabolit af ramipril, ramiprilat, kan kun i ringe grad cleares fra cirkulation ved dialyse.
English: • Headache or feeling tired
Bulgarian: Hovedpine eller træthedsfornemmelse
English: WHAT TRITACE IS AND WHAT IT IS USED FOR TRITACE contains a medicine called ramipril.
Bulgarian: TRITACE indeholder det aktive lægemiddelstof ramipril.
English: Cardiac disorders
Bulgarian: Kardiovaskulær profylakse
English: AVENTIS PHARMA
Bulgarian: Aventis Pharma S.A.
English: • Hair loss.
Bulgarian: • Svimmelhed.
English: UK
Bulgarian: England
English: • Sexual inability in men, reduced sexual desire in men or women
Bulgarian: Nedsat libido hos mænd og kvinder
English: -Agranulatocytosis: the warning should be expanded to include bone marrow depression and other effects on blood.
Bulgarian: skal udvides til at omfatte knoglemarvsdepression og andre påvirkninger af blodet.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines).
Bulgarian: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Estonia : Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
Bulgarian: Estland : Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
English: The CHMP adopted the following wording in order to implement this section: -“ Renal Impairment: the warning should be expanded to include not just treatment in patients with renal impairment but the risk of subsequent renal impairment, risk factors and need for early discontinuation.
Bulgarian: til også at omfatte ikke kun behandling hos patienter med nedsat nyrefunktion, men også risiko for efterfølgende nedsat nyrefunktion, risikofaktorer og behov for tidlig seponering.
English: PHARMACEUTICAL FORM AND CONTENTS
Bulgarian: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
English: o Elderly patients See section 4.2.
Bulgarian: o Ældre patienter Se pkt.
English: UNDESIRABLE EFFECTS
Bulgarian: BIVIRKNINGER
English: Eosinophilia White blood cell count decreased (including neutropenia or agranulocytosis) , red blood cell count decreased, haemoglobin decreased, platelet count decreased
Bulgarian: Fald i hvide blodlegemer (inklusiv neutropeni eller agranulocytose), fald i hæmatokrit, fald i hæmoglobin, fald i trombocyttal.
English: Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Bulgarian: Patienter der planlægger graviditet bør skiftes til alternativ antihypertensiv behandling, der besidder en etablereret
English: Starting dose: The recommended initial dose is 2.5 mg of TRITACE once daily.
Bulgarian: Startdosis: Den anbefalede startdosis er 2,5 mg TRITACE en gang daglig.
English: SANOFI-AVENTIS D.O.O.
Bulgarian: SANOFI-AVENTIS S.A.
English: Latvia: Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
Bulgarian: Letland: Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes
English: Bulgaria: Tritace 2.5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки
Bulgarian: Bulgarien: Tritace 2.5 mg таблетки, Tritace 5 mg таблетки, Tritace 10 mg таблетки
English: If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Bulgarian: Er du i tvivl, så spørg lægen eller på apoteket.
English: Skin and subcutaneous tissue disorders
Bulgarian: Hud og subkutane væv Udslæt, særligt makulopapulært
English: SANOFI-AVENTIS DEUTSCHLAND GMBH Industriepark Hoechst D-65926 Frankfurt am Main Germany
Bulgarian: Industriepark Hoechst D-65926 Frankfurt am Main Tyskland
English: Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure.
Bulgarian: Symptomerne på overdosering kan være kraftig perifer vasodilation (med kraftig hypotension, shock) bradykardi, elektrolytforstyrrelse og nyreinsufficiens. Patienten bør monitoreres tæt, og behandles symptomatisk og understøttende.
English: Lithuania: Cardace 2.5 mg tabletės, Cardace 5 mg tabletės, Cardace 10 mg tabletės
Bulgarian: Litauen: Cardace 2.5 mg tabletės, Cardace 5 mg tabletės, Cardace 10 mg tabletės
English: Slovenia: Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete
Bulgarian: Slovenien: Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete
English: Starting dose The recommended initial dose is 2.5 mg of TRITACE once daily.
Bulgarian: Startdosis Den anbefalede startdosis er 2,5 mg TRITACE en gang daglig.
English: months of pregnancy, see section “Pregnancy and breast-feeding”.
Bulgarian: TRITACE anbefalse ikke de første tre måneder af graviditeten, se afsnittet ”Graviditet og amning”
English: Do not take TRITACE:
Bulgarian: Indtagelse af TRITACE:
English: In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration.
Bulgarian: Hos de fleste patienter ses den antihypertensive effekt fra behandlingsstart med en enkelt dosis 1
English: Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction.
Bulgarian: Hvis dosis ikke kan øges til 2,5 mg to gange daglig, bør behandlingen seponeres. Der er stadig utilstrækkelig erfaring med behandlingen af patienter med alvorlig (NYHA IV) hjerteinsufficiens umiddelbart efter myokardieinfarkt.
English: FURTHER INFORMATION What TRITACE.contains [To be completed nationally] What TRITACE looks like and contents of the pack Tablets, hard capsules [To be completed nationally]
Bulgarian: Udseende og pakningsstørrelser Tabletter, kapsler, hårde [Udfyldes nationalt]
English: You should check with your doctor or pharmacist if you are not sure.
Bulgarian: Kontakt din læge eller spørg på apoteket, hvis du har nogen spørgsmål, eller er i tvivl om noget.
English: Loavel 1.25mg capsules Loavel 2.5mg capsules Loavel 5mg capsules Loavel 10mg capsules
Bulgarian: Loavel 1.25mg Kapsler Loavel 2.5mg Kapsler Loavel
English: The maximal dose is 10 mg daily.
Bulgarian: Maksimumdosen er 10 mg dagligt.
English: Myocardial ischaemia including angina pectoris or myocardial infarction,
Bulgarian: Myokardiel iskæmi inklusive angina pectoris og myokardieinfarkt, takykardi, arrhytmia, palpitationer, perifert ødem.
English: • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Bulgarian: • Tal med lægen eller apoteket, hvis en bivirkninger bliver værre, eller du får bivirkninger, der ikke er nævnt her.
English: They can make TRITACE work less well:
Bulgarian: De kan nemlig mindske virkningen af TRITACE:
English: Ramipril 1.25mg capsules Ramipril 2.5mg capsules Ramipril 5mg capsules Ramipril 10mg capsules
Bulgarian: Ramipril 1.25mg Kapsler Ramipril 2.5mg Kapsler Ramipril
English: SANOFI-AVENTIS S.A. Josep Pla 2
Bulgarian: Josep Pla 2
English: Ramace 1.25 mg tabletten/comprimés/ Tabletten , Ramace 2.5 mg tabletten/comprimés/ Tabletten , Ramace 5 mg tabletten/comprimés/ Tabletten
Bulgarian: Tritace 1.25 mg tabletten/comprimés/ Tabletten, Tritace 2.5 mg tabletten/comprimés/ Tabletten
English: Uncommon (affects less than 1 in 100 people)
Bulgarian: Ikke almindelige bivirkninger (forekommer hos færre end 1 ud af 100 patienter):
English: • Change in the way things smell
Bulgarian: Forstyrrelse af lugtesansen
English: Starting dose: The recommended initial dose is 1.25 mg of TRITACE once daily.
Bulgarian: Startdosis Den anbefalede startdosis er 1,25 mg TRITACE en gang daglig.
English: Sanofi-aventis One Onslow Street Guildford
Bulgarian: Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK
English: Antidiabetic agents including insulin: Hypoglycaemic reactions may occur.
Bulgarian: Antidiabetika inklusiv insulin:
English: Delix 1.25 mg Kapseln, Delix 2.5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln Vesdil 1.25 mg Kapseln, Vesdil 2.5 mg Kapseln, Vesdil 5 mg Kapseln, Vesdil 1.25 mg Tabletten, Vesdil 2.5 mg Tabletten
Bulgarian: Delix 1.25 mg Kapseln, Delix 2.5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln Vesdil 1.25 mg Kapseln, Vesdil 2.5 mg Kapseln, Vesdil 5 mg Kapseln, Vesdil 1.25 mg Tabletten, Vesdil 2.5 mg Tabletten Vesdil N 2.5 mg Tabletten, Vesdil N 5 mg Tabletten Vedil 5 mg Tabletten
English: Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose.
Bulgarian: system kan efter den første dosis opleve et særligt stort blodtryksfald.
English: DK-2970 Hoersholm
Bulgarian: 2970 Hørsholm
English: AVENTIS PHARMA DEUTSCHLAND GMBH Brüningstraße 50
Bulgarian: AVENTIS PHARMA DEUTSCHLAND GmbH
English: WINTHROP MEDICAMENTS 1-13, Boulevard Romain Roland F-75014 Paris
Bulgarian: 1-13, Boulevard Romain Roland F-75014 Paris
English: Marketing Authorisation Holder (Invented) name
Bulgarian: Indehaver af markedsføringstil- (Lokalt) Navn ladelsen
English: • Heartburn, constipation or dry mouth
Bulgarian: Halsbrand, forstoppelse eller mundtørhed
English: LIST OF EXCIPIENTS [To be completed nationally]
Bulgarian: LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: Czech Republic AVENTIS PHARMA DEUTSCHLAND GMBH Industriepark Höchst
Bulgarian: AVENTIS PHARMA DEUTSCHLAND GMBH
English: A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients.
Bulgarian: Ramipril var standardbehandling hos 9.200 patienter i et præventivt, placebokontrolleret studie (HOPEstudiet).
English: Slovak Republic
Bulgarian: Slovakiet
English: TRITACE has to be swallowed with liquid.
Bulgarian: 5.2 TRITACE skal synkes med væske.
English: PHARMACOKINETIC PROPERTIES
Bulgarian: 5.2 Farmakokinetiske egenskaber
English: • As treatment following heart attack (myocardial infarction) complicated with heart failure.
Bulgarian: i hjertet (myocardie infarkt) og hjertesvigt.
English: HOW TO TAKE TRITACE
Bulgarian: SÅDAN SKAL DU TAGE TRITACE
English: - Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or o diabetes with at least one cardiovascular risk factor (see section 5.1).
Bulgarian: slagtilfælde eller perifer vaskulær sygdom i anamnesen) eller o Diabetes med mindst én kardiovaskulær risikofaktor (se pkt.
English: Considering the available data the CHMP adopted the following indication: “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: I betragtning af de tilgængelige data vedtog CHMP følgende indikation: ”Sekundær profylakse efter akut myokardieinfarkt:
English: Belgium Aventis Pharma S.A. Boulevard de la Plaine, 9
Bulgarian: Boulevard de la Plaine, 9 B-1050 Bruxelles
English: • Cramps or pain in your muscles
Bulgarian: Muskelkramper eller muskelsmerter
English: Slovak Republic: Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety
Bulgarian: Slovakiet: Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety
English: EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Bulgarian: 4.7 Virkning på evnen
English: • This medicine has been prescribed for you.
Bulgarian: Lægen har ordineret TRITACE til dig personligt.
English: Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Bulgarian: Tritace og tilknyttede navne kan bruges som monoterapi eller
English: Read all of this leaflet carefully before you start taking this medicine.
Bulgarian: inden du begynder at tage medicinen.
English: Starting dose
Bulgarian: Startdosis
English: • The usual dose is 10 mg daily.
Bulgarian: Den almindelige dosis er 10 mg dagligt.
English: TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRITACE and associated names (see Annex I) 10 mg tablets
Bulgarian: TRITACE og associerede navne (se bilag I) 1.25 mg tabletter TRITACE og associerede navne (se bilag I) 2.5 mg tabletter TRITACE og associerede navne (se bilag I) 5 mg tabletter TRITACE og associerede navne (se bilag I) 10 mg tabletter
English: • Nail problem (e.g. loosening or separation of a nail from its bed)
Bulgarian: Negle problemer (f.eks. at de løser
English: • You may be started on a dose of 1.25 mg or 2.5 mg once daily.
Bulgarian: sandsynligvis opstartet på en dosis på 1,25 mg eller 2,5 mg én gang dagligt Din læge vil herefter justere din dosis
English: DEUTSCHLAND GmbH 65926 Frankfurt am Main Germany
Bulgarian: D-65926 Frankfurt am Main Tyskland
English: Diuretic-Treated patients
Bulgarian: − Patienter planlagt
English: Check with your doctor or pharmacist before taking your medicine:
Bulgarian: Vær ekstra forsigtig med at tage TRITACE Tal med din læge eller apoteket, hvis du:
English: RAMIPRIL WINTHROP 1.25 MG RAMIPRIL WINTHROP 2.5 MG, COMPRIME SECABLE RAMIPRIL WINTHROP 5 MG, COMPRIME SECABLE RAMIPRIL WINTHROP 10 MG, COMPRIME SECABLE
Bulgarian: RAMIPRIL WINTHROP 1.25 MG RAMIPRIL WINTHROP 2.5 MG, COMPRIME SECABLE
English: PACKAGE LEAFLET
Bulgarian: • Lysskyhed
English: OVERDOSE
Bulgarian: 4.9 Overdosering
English: TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules [See Annex I - To be completed nationally]
Bulgarian: TRITACE og associerede navne (se bilag I) 1.25 mg hårde kapsler TRITACE og associerede navne (se bilag I) 2.5 mg hårde kapsler TRITACE og associerede navne (se bilag I) 5 mg hårde kapsler TRITACE og associerede navne (se bilag I) 10 mg hårde kapsler [Se bilag I - Udfyldes nationalt]
English: POSSIBLE SIDE EFFECTS
Bulgarian: Hvis du oplever bivirkninger der
English: Conjunctivitis
Bulgarian: Forvirring
English: • Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)
Bulgarian: Hvide ”døde” fingre og tæer (Raynaud's phenomen)
English: • Pain in your joints
Bulgarian: Får dine blodkar
English: TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules
Bulgarian: TRITACE og associerede navne (se bilag I) 1.25 mg hårde kapsler TRITACE og associerede navne (se bilag I) 2.5 mg hårde kapsler TRITACE og associerede navne (se bilag I) 5 mg hårde kapsler TRITACE og associerede navne (se bilag I) 10 mg hårde kapsler
English: Lithuania
Bulgarian: Lithauen
English: B-1050 Bruxelles
Bulgarian: A-1037 Wien
English: PHARMACODYNAMIC PROPERTIES
Bulgarian: 5.1 Farmakodynamiske egenskaber
English: Ramipril 1.25mg tablets Ramipril 2.5mg tablets Ramipril 5mg tablets Ramipril 10mg tablets
Bulgarian: Ramipril 1.25mg Tabletter Ramipril 2.5mg Tabletter Ramipril
English: In summary, pregnancy and lactation should be amended in line with PhVWP recommendations on ACE-I The following should be added to the contraindication:
Bulgarian: Et eller flere lokale produktresuméer indeholder kontraindikationer. Sammenfattende skal graviditet og amning ændres i overensstemmelse med anbefalinger for ACE-I fra arbejdsgruppen vedrørende lægemiddelovervågning.
English: Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products”.
Bulgarian: i kombination med andre klasser af lægemidler mod hypertension”.
English: triamterene, amiloride, potassium salts and heparin (for thinning blood)
Bulgarian: Medicin der kan øge indholdet af kalium i blodet såsom spironolakton, triamterene, amilorid, kalium salteog heparin (blodfortyndende middel)
English: (See also 5.3 'Preclinical safety data').
Bulgarian: (se punkt 4.3).
English: Triatec 1.25 mg tabletter, Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg kapsler
Bulgarian: Triatec 1.25 mg tabletter, Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg kapsler, hårde
English: • Stomach or gut pain, diarrhoea, indigestion, feeling or being sick
Bulgarian: Mavepine, diarré, fordøjelsesbesvær, kvalme, opkast
English: Patients with hepatic impairment (see section 5.2) In patients with hepatic impairment, treatment with TRITACE must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg TRITACE.
Bulgarian: − Hos hæmodialyserede, hypertensive patienter: Ramipril er svagt dialysérbart; startdosis er 1,25 mg daglig, og maksimal dosis er 5 mg, lægemidlet bør administreres få timer efter udført hæmodialyse.
English: POSOLOGY AND METHOD OF ADMINISTRATION
Bulgarian: Dosering og indgivelsesmåde
English: Treatment after you have had a heart attack
Bulgarian: • Til behandling af hjertet, når det
English: Tritace 1.25mg capsules Tritace 2.5mg capsules Tritace 5mg capsules Tritace 10mg capsules
Bulgarian: Tritace 1.25mg Kapsler Tritace 2.5mg Kapsler Tritace 5mg Kapsler Tritace 10mg Kapsler
English: If you take more TRITACE than you should
Bulgarian: Hvis du har du har taget for meget TRITACE
English: • Severe stomach pain which may reach through to your back.
Bulgarian: Alvorlig mavepine der strækker
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Bulgarian: EVENTUELLE SÆRLIGE ADVARSLER
English: • Increased or irregular heartbeatsSwollen arms and legs.
Bulgarian: Hævede arme og ben.
English: - Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney -2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)”
Bulgarian: − Signifikant bilateral renal ateriestenose eller renal arteriestenose i en enkelt fungerende nyre.
English: Lithium level must be monitored.
Bulgarian: skal monitoreres.
English: General disorders and
Bulgarian: Stigning i leverenzymer og/eller
English: To reduce the risk of you having a heart attack or stroke
Bulgarian: i hjertet eller slagtilfælde
English: Precautions for use
Bulgarian: Virkning og anvendelse
English: Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
Bulgarian: Polen: Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
English: Tritace 1.25mg tablets Tritace 2.5mg tablets Tritace 5mg tablets Tritace 10mg tablets
Bulgarian: Tritace 1.25mg Tabletter Tritace 2.5mg Tabletter Tritace 5mg Tabletter Tritace 10mg Tabletter
English: Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Bulgarian: Grundet utilstrækkelig tilgængelig information angående brugen af ramipril ved amning (se pkt. 5.2), kan ramipril