natgillin/translations-raw huggingface dataset:
Irbesartan Hydrochlorothiazide Winthrop bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for irbesartan, hydrochlorothiazid, sulfonamider eller nogen af de øvrige indholdsstoffer.
Irbesartan Hydrochlorothiazide Winthrop should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Irbesartan Hydrochlorothiazide Winthrop må heller ikke gives til patienter, som har svære lever -, nyre - eller galdeproblemer, for lavt indhold af kalium i blodet eller for højt indhold af kalcium i blodet.
Irbesartan Hydrochlorothiazide Winthrop should also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Der skal udvises forsigtighed, når Irbesartan Hydrochlorothiazide Winthrop anvendes sammen med andre lægemidler, som kan påvirke indholdet af kalium i blodet.
Care must be taken when using Irbesartan Hydrochlorothiazide Winthrop with other medicines that have an effect on blood potassium levels.
Hvorfor blev Irbesartan Hydrochlorothiazide Winthrop godkendt?
Why has Irbesartan Hydrochlorothiazide Winthrop been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Irbesartan Hydrochlorothiazide Winthrop er større end risiciene ved behandling af essentiel hypertension hos patienter, hvis blodtryk ikke kan reguleres tilfredsstillende ved hjælp af irbesartan eller hydrochlorothiazid alene.
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide Winthrop’ s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Irbesartan Hydrochlorothiazide Winthrop.
The Committee recommended that Irbesartan Hydrochlorothiazide Winthrop be given marketing authorisation.
Andre oplysninger om Irbesartan Hydrochlorothiazide Winthrop:
Other information about Irbesartan Hydrochlorothiazide Winthrop:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan Hydrochlorothiazide Winthrop til Sanofi Pharma Bristol- Myers Squibb SNC den 19. januar 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide Winthrop to Sanofi Pharma Bristol-Myers Squibb SNC on 19 January 2007.
Den fuldstændige EPAR for Irbesartan Hydrochlorothiazide Winthrop findes her.
The full EPAR for Irbesartan Hydrochlorothiazide Winthrop is available here.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg tabletter
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg tablets.
Irbesartan Hydrochlorothiazide Winthrop kan administreres 1 gang dagligt med eller uden samtidig fødeindtagelse.
Irbesartan Hydrochlorothiazide Winthrop can be taken once daily, with or without food.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene; Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12, 5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12, 5 mg.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg.
4. 5).
When necessary, Irbesartan Hydrochlorothiazide Winthrop may be administered with another antihypertensive medicinal product (see section 4.5).
På grund af hydrochlorthiazid- komponenten anbefales Irbesartan Hydrochlorothiazide Winthrop ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/ min).
Renal impairment: due to the hydrochlorothiazide component, Irbesartan Hydrochlorothiazide Winthrop is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/ min).
Hypovolæmi og/ eller hyponatriæmi skal korrigeres forud for behandling med Irbesartan Hydrochlorothiazide Winthrop.
2 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
2 Leverfunktionsnedsættelse:
Hepatic impairment:
Irbesartan Hydrochlorothiazide Winthrop er ikke indiceret til patienter med svært nedsat leverfunktion.
Irbesartan Hydrochlorothiazide Winthrop is not indicated in patients with severe hepatic impairment.
4. 3).
No dosage adjustment of Irbesartan Hydrochlorothiazide Winthrop is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Dosisjustering af Irbesartan Hydrochlorothiazide Winthrop til ældre patienter er ikke nødvendig.
Elderly patients: no dosage adjustment of Irbesartan Hydrochlorothiazide Winthrop is necessary in elderly patients.
Irbesartan Hydrochlorothiazide Winthrop er kun sjældent blevet associeret med symptomatisk hypotension hos hypertensive patienter uden andre risikofaktorer for hypotension.
Irbesartan Hydrochlorothiazide Winthrop has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Sådanne tilstande skal korrigeres inden initiering af behandling med Irbesartan Hydrochlorothiazide Winthrop.
Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Winthrop.
Selvom dette ikke er dokumenteret for Irbesartan Hydrochlorothiazide Winthrop, kan der forventes en tilsvarende effekt.
While this is not documented with Irbesartan Hydrochlorothiazide Winthrop, a similar effect should be anticipated.
Når Irbesartan Hydrochlorothiazide Winthrop anvendes til patienter med nedsat nyrefunktion, anbefales periodisk monitorering af serum- kalium, serum- kreatinin og serum- urinsyre- niveauer.
Renal impairment and kidney transplantation: when Irbesartan Hydrochlorothiazide Winthrop is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Der er ingen erfaring med administration af Irbesartan Hydrochlorothiazide Winthrop til nyligt nyretransplanterede patienter.
There is no experience regarding the administration of Irbesartan Hydrochlorothiazide Winthrop in patients with a recent kidney transplantation.
Der er ingen klinisk erfaring med Irbesartan Hydrochlorothiazide Winthrop hos patienter med nedsat leverfunktion.
There is no clinical experience with Irbesartan Hydrochlorothiazide Winthrop in patients with hepatic impairment.
Derfor frarådes brug af Irbesartan Hydrochlorothiazide Winthrop.
Therefore, the use of Irbesartan Hydrochlorothiazide Winthrop is not recommended.
Der er dog rapporteret minimal eller ingen effekt ved en dosis på 12, 5 mg, som findes i Irbesartan Hydrochlorothiazide Winthrop.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide Winthrop, minimal or no effects were reported.
Det er især tilfældet ved nyrefunktionsnedsættelse og/ eller hjertesygdom og diabetes mellitus.
Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide Winthrop hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
4. 5).
Potassium-sparing diuretics, potassium supplements or potassium- containing salts substitutes should be co-administered cautiously with Irbesartan Hydrochlorothiazide Winthrop (see section 4.5).
4. 5).
Lithium: the combination of lithium and Irbesartan Hydrochlorothiazide Winthrop is not recommended (see section 4.5).
Irbesartan Hydrochlorothiazide Winthrops antihypertensive virkning kan øges ved samtidig administration af andre antihypertensive stoffer.
Other antihypertensive agents: the antihypertensive effect of Irbesartan Hydrochlorothiazide Winthrop may be increased with the concomitant use of other antihypertensive agents.
Derudover reducerer thiazider nyreclearance af lithium og dermed øges risikoen for lithiumtoksicitet ved behandling med Irbesartan Hydrochlorothiazide Winthrop.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Winthrop.
4. 4).
Therefore, the combination of lithium and Irbesartan Hydrochlorothiazide Winthrop is not recommended (see section 4.4).
Det anbefales at måle serum- kalium periodisk, når Irbesartan Hydrochlorothiazide Winthrop administreres sammen med lægemidler, der påvirkes af serum- kaliumforstyrrelser (fx digitalisglykosider, antiarytmika).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide Winthrop is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Yderligere information om irbesartaninteraktioner:
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Irbesartans farmakokinetik er i kliniske forsøg ikke blevet påvirket af hydrochlorthiazid.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser
Irbesartan metaboliseres hovedsageligt af CYP2C9 og i mindre udstrækning ved glucuronidering.
5 extent by glucuronidation.
Effekten af CYP2C9- induktorer, som fx rifampicin på irbesartans
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Der findes ingen kontrollerede epidemiologiske data vedrørende risikoen med Angiotensin II- Receptor - Antagonister (AIIRAer), men lignende risici kan findes for denne lægemiddelgruppe.
Unless continued
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRAer skønnes nødvendig.
6 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.
Irbesartan Hydrochlorothiazide Winthrop indeholder hydroclorthiazid og kan derfor ikke anbefales under graviditetens første trimester.
Since Irbesartan Hydrochlorothiazide Winthrop contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Irbesartan Hydrochlorothiazide Winthrop er kontraindiceret under amning.
Irbesartan Hydrochlorothiazide Winthrop is contraindicated during breast-feeding.
På baggrund af de farmakodynamiske egenskaber er det dog usandsynligt, at Irbesartan Hydrochlorothiazide Winthrop vil påvirke denne evne.
Based on its pharmacodynamic properties, Irbesartan Hydrochlorothiazide Winthrop is unlikely to affect this ability.
Udover ovenfor nævnte bivirkninger for kombinationspræparatet, kan andre tidligere rapporterede bivirkninger i forbindelse med ét af de individuelle stoffer være potentielle bivirkninger ved Irbesartan Hydrochlorothiazide Winthrop.
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse events previously reported with one of the individual components may be potential adverse events with Irbesartan Hydrochlorothiazide Winthrop.
De dosisafhængige bivirkninger med hydrochlorthiazid (specielt elektrolytforstyrrelser) kan øges ved anvendelse af højere dosis af hydrochlorthiazid.
9 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Der foreligger ikke specifikke oplysninger om behandling af overdosering med Irbesartan Hydrochlorothiazide Winthrop.
No specific information is available on the treatment of overdose with Irbesartan Hydrochlorothiazide Winthrop.
9 symptomatisk og understøttende.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Irbesartan Hydrochlorothiazide Winthrop er en kombination af en angiotensin- II receptorantagonist, irbesartan, og et thiaziddiuretikum, hydrochlorthiazid.
Irbesartan Hydrochlorothiazide Winthrop is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Kombinationen af hydrochlorthiazid og irbesartan giver en dosisrelateret additiv reduktion af blodtrykket over hele det terapeutiske dosisinterval for de enkelte lægemidler.
10 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Tillæg af 12, 5 mg hydrochlorthiazid til 300 mg irbesartan, 1 gang dagligt hos patienter, der ikke er adækvat behandlede med 300 mg irbesartan alene, medførte yderligere placebo- korrigeret diastolisk blodtryksreduktion ved laveste måling (24 timer efter dosis) på 6, 1 mmHg.
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg var 100%, når blodtrykket blev monitoreret ambulant.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg were 100%.
Forholdet mellem den laveste og den maksimale effekt var henholdsvis 68% og 76% for Irbesartan Hydrochlorothiazide Winthrop 150 mg / 12, 5 mg og Irbesartan Hydrochlorothiazide Winthrop 300 mg / 12, 5 mg, når effekten blev målt med blodtryksmanchet ved kontrolbesøg.
The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg and Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg, respectively.
I langsigtede opfølgningsstudier blev virkningen af irbesartan/ hydrochlorthiazid opretholdt i mere end 1 år.
The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 6-8 weeks.
Der er hverken observeret rebound- hypertension for irbesartan eller hydrochlorthiazid.
In long-term follow-up studies, the effect of irbesartan/ hydrochlorothiazide was maintained for over one year.
Dette er dog ikke undersøgt specifikt for Irbesartan Hydrochlorothiazide Winthrop.
Although not specifically studied with the Irbesartan Hydrochlorothiazide Winthrop, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Virkningen af Irbesartan Hydrochlorothiazide Winthrop afhænger ikke af alder eller køn.
There is no difference in response to Irbesartan Hydrochlorothiazide Winthrop, regardless of age or gender.
Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af Irbesartan Hydrochlorothiazide Winthrop som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
Efficacy and safety of Irbesartan Hydrochlorothiazide Winthrop as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicenter, randomized, double- blind, active-controlled, 8-week, parallel-arm study.
Ialt 697 patienter randomiseredes i forholdet 2: 1 til irbesartan/ hydrochlorothiazid 150 mg/ 12, 5 mg eller irbesartan 150 mg, og med systematisk titrering (inden evaluering af respons på den lavere dosis) efter 1 uge til henholdsvis irbesartan/ hydrochlorothiazid 300 mg/ 25 mg eller irbesartan 300 mg.
A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/ hydrochlorothiazide 150 mg/ 12.5 mg or to irbesartan 150 mg and systematically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/ hydrochlorothiazide 300 mg/ 25 mg or irbesartan 300 mg, respectively.
Det primære formål med forsøget var at sammenligne andelen af patienter hvis SeDBT var kontrolleret (SeDBT < 90 mmHg) ved Uge 5.
11 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
47, 2% af patienterne i kombinationsbehandling nåede et dal- SeDBT < 90 mmHg sammenlignet med 33, 2% af patienterne behandlet med irbesartan (p = 0, 0005).
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
172/ 113 mmHg i begge
The mean baseline blood pressure was approximately 172/ 113 mmHg in each treatment group and decreases of SeSBP/ SeDBP at five weeks were 30.8/ 24.0 mmHg and 21.1/ 19.3 mmHg for irbesartan/ hydrochlorothiazide and irbesartan, respectively (p < 0.0001).
Faldet i SeSBT/ SeDBT ved 5 uger var henholdsvis 30, 8/ 24, 0 mmHg og 21, 1/ 19, 3 mmHg for irbesartan/ hydrochlorothiazid og irbesartan (p < 0, 0001).
The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Ved oral administration af Irbesartan Hydrochlorothiazide Winthrop er den absolutte orale biotilgængelighed 60- 80% for irbesartan og 50- 80% for hydrochlorthiazid.
Following oral administration of Irbesartan Hydrochlorothiazide Winthrop, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Fødeindtagelse påvirker ikke biotilgængeligheden af Irbesartan Hydrochlorothiazide Winthrop.
Food does not affect the bioavailability of Irbesartan Hydrochlorothiazide Winthrop.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
Irbesartan is not removed by
Irbesartan fjernes ikke ved hæmodialyse.
12 haemodialysis.
Denne toksiske effekt forsvandt efter fødslen.
In rabbits,
Hos kaniner sås abort eller tidlig resorption ved doser, som forårsagede signifikant maternel toksicitet, inklusive mortalitet.
13 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12, 5 mg tabletter
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg tablets.
Hypovolæmi og/ eller hyponatriæmi skal korrigeres forud for behandling med Irbesartan Hydrochlorothiazide Winthrop.
16 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
16 Leverfunktionsnedsættelse:
Hepatic impairment:
Irbesartan metaboliseres hovedsageligt af CYP2C9 og i mindre udstrækning ved glucuronidering.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser
19 farmakokinetik er ikke evalueret.
19 extent by glucuronidation.
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRAer skønnes nødvendig.
20 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.
21 Sygdomme i nyrer og urinveje:
21
22 Hydrochlorthiazid:
Hydrochlorothiazide:
De dosisafhængige bivirkninger med hydrochlorthiazid (specielt elektrolytforstyrrelser) kan øges ved anvendelse af højere dosis af hydrochlorthiazid.
23 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
23 symptomatisk og understøttende.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Kombinationen af hydrochlorthiazid og irbesartan giver en dosisrelateret additiv reduktion af blodtrykket over hele det terapeutiske dosisinterval for de enkelte lægemidler.
24 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Det primære formål med forsøget var at sammenligne andelen af patienter hvis SeDBT var kontrolleret (SeDBT < 90 mmHg) ved Uge 5.
25 The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
Irbesartan fjernes ikke ved hæmodialyse.
26 haemodialysis.
26 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Hos kaniner sås abort eller tidlig resorption ved doser, som forårsagede signifikant maternel toksicitet, inklusive mortalitet.
27 abortion or early resorption was noted at doses causing significant maternal toxicity, including mortality.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12, 5 mg filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide Winthrop 150 mg/ 12.5 mg film-coated tablets.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide Winthrop 300 mg / 12, 5 mg.
Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Winthrop 300 mg/ 12.5 mg.
30 Leverfunktionsnedsættelse:
30 Intravascular volume depletion: volume and/ or sodium depletion should be corrected prior to administration of Irbesartan Hydrochlorothiazide Winthrop.
Sådanne tilstande skal korrigeres inden påbegyndelse af behandling med Irbesartan Hydrochlorothiazide Winthrop.
Such conditions should be corrected before initiating therapy with Irbesartan Hydrochlorothiazide Winthrop.
Thiazidbehandling er associeret med forhøjede kolesterol - og triglycerid- niveauer, Der er dog rapporteret minimal eller ingen effekt ved en dosis på 12, 5 mg som findes i Irbesartan Hydrochlorothiazide Winthrop.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide Winthrop, minimal or no effects were reported.
Derudover reducerer thiazider nyreclearance af lithium og dermed øges risikoen for lithium toksicitet ved behandling med Irbesartan Hydrochlorothiazide Winthrop.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Irbesartan Hydrochlorothiazide Winthrop.
Det anbefales at måle serum- kalium periodisk, når Irbesartan Hydrochlorothiazide Winthrop administreres sammen med lægemidler, der påvirkes af serum- kaliumforstyrrelser (fx digitalis glykosider, antiarytmika).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when Irbesartan Hydrochlorothiazide Winthrop is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
33 farmakokinetik er ikke evalueret.
33 extent by glucuronidation.
Patienter, der planlægger at blive gravide, bør ændre til anden antihypertensiv behandling hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRAer skønnes nødvendig.
34 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.