natgillin/translations-raw huggingface dataset:
Sanofi- aventis Belgien TRITAZIDE Culliganlaan 1C 1831 Diegem Belgien
Sanofi-aventis Belgium Culliganlaan 1C 1831 Diegem Belgium
5mg / 25mg
5mg / 25mg
SANOFI- AVENTIS NETHERLANDS TRITAZIDE Tabletten B. V.
SANOFI-AVENTIS NETHERLANDS B. V.
5mg/ 25mg Kampenringweg 45 D- E (toren D en E) NL- 2803 PE Gouda The Netherlands
Kampenringweg 45 D-E (toren D en E) NL-2803 PE Gouda The Netherlands
5mg/ 25mg
5mg/ 25mg
Box 2043 NL- 2800 BD Gouda Holland Norge - Polen
Box 2043 NL-2800 BD Gouda The Netherlands Norway
SANOFI- AVENTIS DEUTSCHLAND GMBH D- 65926 Frankfurt am Main Tyskland
SANOFI-AVENTIS DEUTSCHLAND GMBH D-65926 Frankfurt am Main Germany
Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740- 244 Porto Salvo Portugal
Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Romanien
Romania
AVENTIS PHARMA DEUTSCHLAND TRITACE 2. 5 PLUS GMBH TRITACE 5 PLUS Brüningstraße 50 65926 Frankfurt am Main Tyskland
AVENTIS PHARMA DEUTSCHLAND GMBH Brüningstraße 50 65926 Frankfurt am Main Germany
SANOFI- AVENTIS SLOVAKIA s. r. o., TRITAZIDE Žilinská 7- 9 TRITAZIDE 81105 Bratislava Slovakiet
SANOFI-AVENTIS SLOVAKIA s. r. o., Ž ilinská 7-9 81105 Bratislava Slovak Republic
TRITAZIDE 2. 5 5 mg / 12, 5 mg Dunajska cesta 119 Tablettere
Dunajska cesta 119
1000 Ljubljana TRITAZIDE 5 mg / 25 mg Slovenien Tablettere
1000 Ljubljana Slovenia -
5 mg/ 25mg
TRITAZIDE 5 mg/ 25 mg tablete
Spanien
5 mg/ 25mg
-
Sweden
Sverige
sanofi-aventis AB
sanofi- aventis AB TRIATEC COMP MITE Box 14142 TRIATEC COMP 167 14 Bromma Sverige
TRIATEC COMP MITE
2. 5 mg / 12. 5mg 5 mg / 25mg
2.5 mg / 12.5mg
England
Strength
-
TRIATEC COMP
6 BILAG II
5 mg / 25mg
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
-
7 FAGLIGE KONKLUSIONER
7 ANNEX II
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF TRITAZIDE OG TILKNYTTEDE NAVNE (SE BILAG I)
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Tritazide indeholder ramipril, en andengenerations non- sulfhydryl angiotensinkonverterende enzymhæmmer (ACE- I), og hydrochlorothiazid (HCTZ), et thiazid- diuretikum.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TRITAZIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Tritazide stod på den liste over produkter, for hvilke produktresuméerne skulle harmoniseres, som CMD( h) havde udarbejdet i henhold til artikel 30, stk.
Tritazide contains Ramipril, a second-generation nonsulfhydryl angiotensin converting enzyme inhibitor (ACE-I), and Hydrochlorothiazide (HCTZ), a thiazide diuretic.
2, i direktiv 2001/ 83/ EF, med senere ændringer, da produktresuméet for ovennævnte lægemiddel ikke er det samme i de forskellige medlemsstater, Island og Norge.
Tritazide 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.
Kritisk vurdering CHMP har vurderet en række områder, hvor der fandtes uoverensstemmelser i produktinformationen for Tritazide, og en revideret produktinformation blev vedtaget.
Critical Evaluation A number of areas of disharmony in the product information for Tritazide have been evaluated by the CHMP and a revised PI was adopted.
4. 1 Terapeutisk indikation
4.1 Therapeutic Indication
Kombinationen 2, 5 mg/ 12, 5 mg medførte større fald i blodtrykket end behandling med enkeltkomponenter, og kombinationen af 5 mg/ 25 mg havde en bedre terapeutisk effekt, end når dosis af ramipril blev fordoblet til 10 mg.
The combination 2.5mg / 12.5mg led to greater reduction in blood pressure than the treatment with individual components, and the combination of 5mg/ 25mg produced a better therapeutic effect than doubling the ramipril dose to 10mg.
I betragtning af, at der ikke er nogen større problemer i forhold til sikkerhed, effekt og kliniske bivirkninger i forbindelse med kombinationen ramipril/ HCTZ hos patienter, der ikke responderer på HCTZ og ramipril alene, vedtog CHMP følgende to harmoniserede formuleringer af indikationer:
Considering that no major concern can be established concerning the safety, efficacy and clinical adverse event of the ramipril/ HCTZ combination in non responders to HCTZ and ramipril alone, the CHMP adopted the following two harmonised wordings for indications: -Treatment of essential hypertension -This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
- Behandling af essentiel hypertension
4.2 Posology and Method of Administration
4. 4) og blodtrykskontrol.
The CHMP adopted the harmonised wording: “ The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
De maksimale tilladte doser er 10 mg ramipiril og 25 mg hydrochlorothiazid dagligt. "
If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily”
Der var dog visse kontraindikationer, hvor HCTZ fremgik af lokale produktresuméer og ikke fremgik af det harmoniserede produktresumé.
There were however some contraindications with HCTZ labelled in some local SPC’ s and not proposed in the harmonised SPC.
CMPH vedtog den harmoniserede formulering af kontraindikationerne:
The CHMP adopted the harmonised wording for the contra-indictations:
- Overfølsomhed over for det aktive stof eller over for andre angiotensinkonverterende
9 -Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme) inhibitor, hydrochlorothiazide, other thiazide diuretics, sulphonamides or any of the excipients of TRITAZIDE and associated names (see section 6.1).
- Tidligere hereditært eller idiopatisk angioødem
- History of hereditary or idiopathic angioedema
- Ekstrakorporale behandlinger, som medfører kontakt med blod med negativt ladede overflader (se
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see
4. 5)
section 4.5)
- Signifikant bilateral nyrearteriestenose eller nyrearteriestenose i en enkelt fungerende nyre
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
4. 4 og 4. 6)
- -2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
4. 6)
- Lactation (see section 4.6)
- Svært nedsat nyrefunktion med en kreatininclearance på under 30 ml/ min. hos patienter, der ikke er i
- Severe impairment of renal function with a creatinine clearance below 30 ml/ min in undialysed
dialysebehandling
patients
- Klinisk relevante elektrolytforstyrrelser, som kan forværre den efterfølgende behandling med
- Clinically relevant electrolyte disturbances which may worsen following treatment with TRITAZIDE
TRITAZIDE (se pkt.
(see section 4.4)
- Svært nedsat leverfunktion, leverencefalopati.
- Severe impairment of liver function, hepatic encephalopathy
"Kombinationen af ramipril og hydrochlorothiazid udgør ikke et behandlingstilbud mod primær hyperaldosteroisme.
The CHMP included under this session the warning about Primary Hyperaldosteronism, therefore adopted the following harmonised wording: “ The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
Hvis ramipril og hydrochlorothiazid anvendes til en patient med primær hyperaldosteroisme, kræver det omhyggelig overvågning af kalium- plasma - niveauet ".
If ramipril + hydrochlorothiazide is used in a patient with primary hyperaldosteronism, then careful monitoring of plasma potassium level is required”.
"Der er rapporteret hoste ved brug af ACE- hæmmere.
The CHMP also noted the importance to insert a paragraph regarding cough in line with the warning of previously harmonised ACE-I, therefore agreed the following: “ Cough has been reported with the use of ACE inhibitors.
Det er karakteristisk for hosten, at den er nonproduktiv, vedvarende og ophører ved seponering af behandlingen.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
ACE- hæmmerinduceret hoste skal overvejes som en del af den differentiale diagnose ved hoste ".
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough”
4. 5 Interaktion
4.5 Interaction
CHMP anbefalede kun en kontraindikation for graviditetens andet og tredje trimester i overensstemmelse med ordlyden fra arbejdsgruppen vedrørende lægemiddelovervågning i forbindelse med brug af ACE- I under graviditet.
The CHMP recommended a contraindication only for the second and third trimester of pregnancy in line with PhVWP wording on use of AEC-I in pregnancy.
Tværtimod skal den ordinerende læge, så snart graviditeten påvises, ophøre med at anvende ACE - hæmmere og om nødvendigt så snart som muligt ændre behandlingen til andre anti- hypertensive lægemidler.
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 anti- hypertensive agent as soon as possible.
CHMP vedtog således en harmoniseret formulering i overensstemmelse med arbejdsgruppen vedrørende lægemiddelovervågnings formulering omkring brugen af ACE- I under graviditet.
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.
CHMP vedtog således en harmoniseret formulering i henhold til arbejdsgruppen vedrørende lægemiddelovervågnings anbefalinger:
In conclusions, the CHMP adopted a harmonised wording in line with PhVWP wording on use of AEC-I in pregnancy.
4. 4) og er kontraindiceret under graviditetens andet og tredje trimester (se pkt.
In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations: “ Tritazide is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Epidemiologiske tegn på risiko for teratogenicitet efter eksponering for ACE- hæmmere under graviditetens første trimester har ikke været entydige, men en mindre stigning i risikoen kan ikke udelukkes.
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.
Medmindre fortsat ACE- hæmmer- terapi skønnes nødvendig, skal patienter, der planlægger graviditet, skifte til alternativ antihypertensiv behandling med bedre sikkerhedsprofiler for brug under
Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established 10 safety profile for use in pregnancy.
Når graviditeten påvises, skal behandling med ACE- hæmmere øjeblikkeligt ophøre, og alternativ behandling skal om nødvendigt igangsættes.
When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Behandling med ACE- hæmmere/ angiotensin II- receptorantagonister (AIIRA) under andet og tredje trimester medfører kendt human fosterforgiftning (nedsat nyrefunktion, oligohydramnion, forsinket forbening af kraniet) og neonatal forgiftning (nyresvigt, hypotension, hyperkaliæmi) (Se også 5. 3 "Prækliniske sikkerhedsdata").
(See also 5.3'Preclinical safety data ').
Såfremt der er sket brug af ACE- hæmmere fra andet trimester af graviditeten, anbefales ultralydskontrol af nyrefunktionen og kranie.
Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
4. 3 og 4. 4) ".
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see also section 4.3 and 4.4 )”.
10 BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
11 GROUNDS FOR AMENDMENT OF THE SUMMARYOF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
- Formålet med indbringelsen af sagen var at harmonisere produktresumé, etikettering og
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- Produktresumé etikettering og indlægsseddel, som indehaveren af markedsføringstilladelsen har
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
foreslået, er blevet vurderet på baggrund af den indsendte dokumentation og udvalgets faglige drøftelse -
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
LÆGEMIDLETS NAVN
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
TRITAZIDE og tilhørende navne (Se bilag I) 2, 5 mg/ 12, 5 mg tabletter TRITAZIDE og tilhørende navne (Se bilag I) 5 mg/ 12, 5 mg tabletter TRITAZIDE og tilhørende navne (Se bilag I) 5 mg/ 25 mg tabletter.
NAME OF THE MEDICINAL PRODUCT TRITAZIDE and associated names (see Annex I) 2.5 mg/ 12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/ 12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/ 25 mg tablets
6. 1
[To be completed nationally] For a full list of excipients, see section 6.1.
Tabletter
Tablet [To be completed nationally]
Behandling af hypertension Dette kombinationspræperat er indiceret til patienter, der ikke kan behandles sufficient med monoterapi.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Det anbefales, at TRITAZIDE tages hver dag på samme tidspunkt, sædvanligvis om morgenen..
It is recommended that TRITAZIDE is taken once daily, at the same time of the day, usually in the morning.
(se pkt.
TRITAZIDE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
5. 2 TRITAZIDE skal synkes med væske.
TRITAZIDE has to be swallowed with liquid.
4. 4) og blodtrykskontrol.
Adults The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Doseringen af kombinationspræperatet af ramipril og hydrochlorothiazid anbefales sædvanligvis efter dosistitrering med en af de individuelle stoffer.
The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.
Maksimal dosis er 10 mg ramipril og 25 mg hydrochlorothiazide dagligt.
If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.
Patienter i diuretisk behandling Da hypotension kan forekomme efter start af behandlingen, anbefales forsigtighed hos patienter der samtidigt behandles med diuretika.
Diuretic-treated patients In patients concurrently treated with diuretics, as hypotension may occur following initiation of the treatment, caution is recommended.
13 TRITAZIDE er kontraindiceret ved alvorlig nedsat nyrefunktion på grund af stoffet hydro- chlorothiazid (Kreatininclearence < 30 ml/ min) (se afsnit 4. 3).
14 Patients with renal impairment TRITAZIDE is contraindicated in severe renal impairment due to the hydrochlorothiazide component (creatinine clearance < 30 ml/ min) (see section 4.3).
Patienter med kreatininclearence mellem 30 og 60 ml/ min bør kun behandles med lavest dosiskombination af ramipril og hydrochlorothiazid efter administration af ramipril alene.
Patients with creatinine clearance levels between 30 and 60 ml/ min should only be treated with the lowest fixed dose combination of ramipril and hydrochlorothiazide after administration of ramipril alone.
Patienter med nedsat leverfunktion Hos patienter med mild til moderat nedsat leverfunktion skal behandling med TRITAZIDE initieres under tæt medicinsk tilsyn med en maksimal daglig dosis på 2, 5 mg ramipril og 12, 5 mg hydrochlorothiazid.
Patients with hepatic impairment In patients with mild to moderate hepatic impairment, treatment with TRITAZIDE must be initiated only under close medical supervision and the maximum daily doses are 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
TRITAZIDE er kontraindiceret ved alvorlig nedsat leverfunktion (se afsnit 4. 3).
TRITAZIDE is contraindicated in severe hepatic impairment (see section 4.3).
Ældre Startdosis bør være lavere og efterfølgende dosistitrering bør se ske mere gradvist, grundet større risiko for bivirkninger, særligt hos meget gamle og skrøbelige patienter.
Elderly Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients.
Pædiatriske patienter TRITAZIDE anbefales ikke til behandling af børn og unge under 18 år, da erfaring med behandling af børn er begrænset.
Paediatric population TRITAZIDE is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
− Overfølsomhed over de aktive stoffer eller over for et eller flere af de øvrige hjælpestoffer, eller andre ACE (Angiotensin Converting Enzyme) - hæmmere (se pkt.
- Hypersensitivity to the active substance or to any other ACE (Angiotensin Converting Enzyme)
6. 1). − Ved angioødem (arveligt eller idiopatisk angioødem, eller grundet tidligere angioødem med ACE - hæmmere eller AIIRA’ ere.) i anamnesen − Ekstrakorporale behandling der fører til blodkontakt med negativt ladede overflader (se pkt.
inhibitor, hydrochlorothiazide, other thiazide diuretics, sulfonamides or any of the excipients of TRITAZIDE (see section 6.1).
4. 5) − Betydelig bilateral renal ateriestenose eller renal arteriestenose i en enkelt fungerende nyre. − Graviditetens andet og tredje trimester (se pkt.
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
4. 4 og 4. 6). − Amning (se afsnit 4. 4) − Alvorlig nedsat leverfunktion, hepatisk encefalopati.
- Severe impairment of renal function with a creatinine clearance below 30 ml/ min in undialysed
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
- Severe impairment of liver function, hepatic encephalopathy
ACE- hæmmere såsom ramipril eller Angiotension II Receptor Antagonister (AIIRA) bør ikke påbegyndes under graviditet.
ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Patienter der planlægger graviditet bør skiftes til alternativ antihypertensiv behandling, der besidder en etablereret sikkerhedsprofil for gravide, medmindre fortsat behandling med ACE- hæmmere/ AIIRA betragtes som essentiel.
Unless continued ACE inhibitor/ AIIRAs 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.
Ved diagnosticering af graviditet skal behandling med ACE- hæmmere og AIIRA seponeres øjeblikkeligt, og der bør opstartes en alternativ behandling (se pkt.
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).
4. 3 og 4. 6).
•
o Patienter med særlig risiko for hypertension
Patients at particular risk of hypotension
- Patienter med stærkt aktiveret renin- angiotensin- aldosteronsystem.
- Patients with strongly activated renin-angiotensin-aldosterone system
Patienter med stærkt aktiveret renin- angiotensin- aldosteronsystem har risiko for udtalt blodtryksfald, og forværrelse af nyrefunktionen grundet ACE- hæmning, særligt når en ACE- hæmmer eller samtidigt diuretikum gives første gange, eller ved første dosisøgning.
15 Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Betydelig aktivering af renin- angiotenson - aldosteronsystemet er forventeligt, og medicinsk opsyn inklusive blodtryksmonitorering er nødvendigt, særligt hos: − Patienter med alvorlig hypertension − Patienter med dekompenseret kongestiv hjerteinsufficiens − Patienter med hæmodynamisk relevant hindret venstreventrikulært indløb eller udløb (f. eks. ved stenose i aorta - eller mitralklap)
Significant activation of renin -angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
14 − Patienter med unilateral renal arteriestenose med en anden fungerende nyre. − Patienter med eksisterende salt og væskemangel eller kan opstå (inklusive patienter som anvender diuretika) − Patienter med levercirrhose og/ eller ascites − Patienter planlagt til større operationer, eller under anæstesi med stoffer der medfører hypotension.
- patients with unilateral renal artery stenosis with a second functional kidney
Kirurgiske indgreb Det anbefales at behandling med angiotensin converting enzyme- hæmmere såsom ramipril seponeres, om muligt en dag før operationen.
Surgery It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
- Patienter med risiko for kardiel - eller cerebral iskæmi i tilfælde af akut hypotension Opstartsfasen af behandlingen kræver særligt medicinsk opsyn.
- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
o - Primær hyperaldosteronisme Kombinationen af ramipril + hydrochlorothiazid reprænsenterer ikke en mulig behandling til primær hyperaldosteronisme.
• Primary Hyperaldosteronism The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
4. 2
• Elderly patients See section 4.2
o Patienter med leversygdom Elektrolytforstyrrelser pga. af diuretika- behandling med hydrochlorothiazid kan forårsage hepatisk encefalopati hos patienter med leversygdom
• Patients with liver disease Electrolyte disturbances due to diuretic therapy including hydrochlorothiazide may cause hepatic encephalopathy in patients with liver disease.
Monitorering af nyrefunktionen Nyrefunktionen bør fastslås før og under behandlingen, og dosis bør justeres i de første uger af behandlingen.
Monitoring of renal function Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment.
4. 2).
Particularly careful monitoring is required in patients with renal impairment (see section 4.2).
Nedsat nyrefunktion Hos patienter med nedsat nyrefunktion kan thiazider fremskynde uræmi.
Renal impairment In patients with renal disease, thiazides may precipitate uraemia.
Hvis progressiv nedsat nyrefunktion forekommer, vist ved en stigende non- protein nitrogen, skal behandlingen nøje genovervejes, med overvejelser om at stoppe diretikabehandlingen.
If progressive renal impairment becomes evident, as indicated by a rising non-protein nitrogen, careful reappraisal of therapy is necessary, with consideration given to discontinuing diuretic therapy (see section 4.3).
Elektrolyforstyrrelser Som ved al diuretika behandling, bør periodiske bestemmelser af serum elektrolytter foretages med passende intervaller.
Electrolyte imbalance As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Selvom hypokaliæmi kan forekomme under behandling med thiaziddiuretika, kan samtidig anvendelse af ramipril nedsætte den diuretikainducerede hypokaliæmi.
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with ramipril may