natgillin/translations-raw huggingface dataset:
Der er efter markedsføring indberettet følgende yderligere bivirkninger:
In addition, since introduction of irbesartan/ hydrochlorothiazide in the market the following adverse reactions have also been reported:
sjældne tilfælde af overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
Rare: rare cases of hypersensitivity reactions such as angioedema, rash, urticaria
og ernæringsbetingede sygdomme:
Metabolism and nutrition disorders:
Tinnitus
tinnitus
Sygdomme i åndedrætsorganer, brysthule og mediastinum:
Respiratory, thoracic and mediastinal disorders:
Dyspepsi, smagsforstyrrelser
dyspepsia, dysgeusia
Sygdomme i bevægeapparatet, bindevæv og knogler:
Musculoskeletal, connective tissue and bone disorders:
4. 4)
impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
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 BMS.
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 BMS.
Bivirkninger rapporteret ved anvendelse af irbesartan alene:
Adverse reactions reported with the use of irbesartan alone include:
8 Hydrochlorthiazid:
Hydrochlorothiazide:
Bivirkninger (uanset relation til lægemidlet) rapporteret ved anvendelse af hydrochlorthiazid alene omfatter:
Adverse events (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone include:
Aplastisk anæmi, knoglemarvsdepression, neutropeni/ agranulocytose, hæmolytisk anæmi, leukopeni, trombocytopeni
Blood and lymphatic system: aplastic anaemia, bone marrow depression, neutropenia/ agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Depression, søvnforstyrrelser
Psychiatric disorders: depression, sleep disturbances
Svimmelhed, paræstesier, uklarhed, rastløshed
Nervous system disorders: vertigo, paraesthesia, light-headedness, restlessness
Forbigående sløret syn, xanthopsia
Eye disorders: transient blurred vision, xanthopsia
Hjertearytmi
Cardiac disorders: cardiac arrhythmias
Postural hypotension
Vascular disorders: postural hypotension
Åndenød (inklusive pneumoni og pulmonalt ødem)
Respiratory, thoracic and mediastinal disorders: respiratory distress (including pneumonitis and pulmonary oedema)
Pancreatitis, anoreksi, diarré, obstipation, gastrisk irritation, sialadenitis, appetitløshed,
Gastrointestinal disorders: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Gulsot (intrahepatisk kolestatisk gulsot)
Hepatobiliary disorders: jaundice (intrahepatic cholestatic jaundice)
Anafylaktiske reaktioner, toksisk epidermal nekrolyse, nekrotiserende angitis (vasculitis, kutan vasculitis), kutan lupus erythematosus- lignende reaktioner, reaktivering af kutan lupus erythematosus, fotosensitivitetsreaktioner, udslæt, urticaria
Skin and subcutaneous tissue disorders: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Svækkelse, muskelspasmer
Musculoskeletal, connective tissue and bone disorders: weakness, muscle spasm
Interstitiel nefritis, nyreinsufficiens
Renal and urinary disorders: interstitial nephritis, renal dysfunction
Feber
General disorders and administration site conditions: fever
4. 4), hyperurikæmi, glukosuri, hyperglykæmi, stigning i kolesterol og triglycerider
Investigations: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
4. 9 Overdosering
9 4.9 Overdose
Patienten skal monitoreres tæt, og behandlingen skal være symptomatisk
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Irbesartan Hydrochlorothiazide BMS er en kombination af en angiotensin- II receptorantagonist, irbesartan, og et thiaziddiuretikum, hydrochlorthiazid.
Irbesartan Hydrochlorothiazide BMS 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.
The addition of 12.5 mg hydrochlorothiazide to
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.
10 300 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.
10 Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er tilstrækkelig regulerede med 300 mg/ 12, 5 mg- kombinationen, kan respondere ved dosisøgning til 300/ 25 mg.
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/ 12.5 mg combination may respond when uptitrated to 300 mg/ 25 mg.
Der er hos disse patienter observeret en øgning i blodtryksreduktionen for såvel systolisk som diastolisk blodtryk (henholdsvis 13, 3 mmHg og 8, 3 mmHg).
In these patients, an incremental blood pressure lowering effect was observed for both SBP and DBP (13.3 and 8.3 mm Hg, respectively).
Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide BMS 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 BMS 150 mg/ 12.5 mg were 100%.
Forholdet mellem den laveste og den maksimale effekt var henholdsvis 68% og 76% for Irbesartan Hydrochlorothiazide BMS 150 mg / 12, 5 mg og Irbesartan Hydrochlorothiazide BMS 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 BMS 150 mg/ 12.5 mg and Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg, respectively.
Dette er dog ikke undersøgt specifikt for Irbesartan Hydrochlorothiazide BMS.
Although not specifically studied with the Irbesartan Hydrochlorothiazide BMS, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Som med andre lægemidler, der påvirker renin- angiotensinsystemer, har sorte, hypertensive patienter betydelig mindre respons på enkeltstofbehandling med irbesartan.
As is the case with other drugs that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
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
Det gennemsnitlige blodtryk ved baseline var ca.
11 (p = 0.0005).
11 Typen og forekomsten af de bivirkninger, der er indberettet hos patienter, som har modtaget behandling med kombinationen, svarede til bivirkningsprofilen for patienter i enkeltstofbehandling.
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 BMS er den absolutte orale biotilgængelighed 60- 80% for irbesartan og 50- 80% for hydrochlorthiazid.
Following oral administration of Irbesartan Hydrochlorothiazide BMS, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
20% radioaktivitet i urinen og resten i afføringen.
After either oral or IV administration of 14 C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/ moderat cirrhose.
12 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
12 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
13 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Mikrokrystallinsk cellulose Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Kolloid silica Prægelatineret majsstivelse Rød og gul jernoxid.
Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg tabletter
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg tablets.
65, 8 mg lactosemonohydrat per tablet.
65.8 mg of lactose monohydrate per tablet.
16 Leverfunktionsnedsættelse:
16 Hepatic impairment:
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin- angiotensinsystemet.
17 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
18 Graviditet:
18 Pregnancy:
19 farmakokinetik er ikke evalueret.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
Ved konstateret graviditet, bør behandling med AIIRAer seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt bør anden behandling iværksættes.
When
20 Der er kendt at behandling med AIIRAer under anden og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets knogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
AIIRAs 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).
Sygdomme i bevægeapparatet, bindevæv og knogler:
21 Musculoskeletal, connective tissue and bone disorders:
21 Sygdomme i nyrer og urinveje:
Renal and urinary disorders:
22 Hydrochlorthiazid:
22
23 og understøttende.
23 4.9 Overdose
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.
24 300 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.
24 Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er tilstrækkelig regulerede med 300 mg/ 12, 5 mg- kombinationen, kan respondere ved dosisøgning til 300/ 25 mg.
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/ 12.5 mg combination may respond when uptitrated to 300 mg/ 25 mg.
Det gennemsnitlige blodtryk ved baseline var ca.
25 (p = 0.0005).
25 Typen og forekomsten af de bivirkninger, der er indberettet hos patienter, som har modtaget behandling med kombinationen, svarede til bivirkningsprofilen for patienter i enkeltstofbehandling.
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.
26 5. 3 Prækliniske sikkerhedsdata
26 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
27 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12, 5 mg filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide BMS 150 mg/ 12.5 mg film-coated tablets.
38, 5 mg lactosemonohydrat per filmovertrukken tablet.
38.5 mg of lactose monohydrate per film-coated tablet.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide BMS 300 mg / 12, 5 mg.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg.
30 Leverfunktionsnedsættelse:
30 Hepatic impairment:
Der er ingen erfaring med behandling af til børn og unge.
Children and adolescents: there is no experience in children and adolescents.
Alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/ min).
Severe renal impairment (creatinine clearance < 30 ml/ min).
Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase.
Severe hepatic impairment, biliary cirrhosis and cholestasis.
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin- angiotensinsystemet.
31 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
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 BMS.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Irbesartan Hydrochlorothiazide BMS, minimal or no effects were reported.
32 Graviditet:
32 Pregnancy:
Det anbefales at måle serum- kalium periodisk, når Irbesartan Hydrochlorothiazide BMS 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 BMS is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Der er ikke observeret signifikante farmakokinetiske eller farmakodynamiske interaktioner ved samtidig administration af irbesartan og warfarin, et lægemiddel som metaboliseres af CYP2C9.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by
33 farmakokinetik er ikke evalueret.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
34 Der er kendt at behandling med AIIRAer under anden og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets knogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
AIIRAs 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).
Seponering på grund af kliniske eller laboratoriemæssige bivirkninger forekom mindre hyppig for irbesartan/ hydrochlorthiazid- behandlede patienter end for placebo- behandlede patienter.
Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan/ hydrochlorothiazide-treated patients than for placebo-treated patients.
Synkope, hypotension, takycardia, ødem,
syncope, hypotension, tachycardia, oedema
35 Sygdomme i bevægeapparatet, bindevæv og knogler:
35 Musculoskeletal, connective tissue and bone disorders:
Øget serum- carbamid, kreatinin og kreatin kinase Fald i serum- kalium og natrium
increases in BUN, creatinine and creatine kinase decreases in serum potassium and sodium
Sjældne tilfælde af overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
Rare: rare cases of hypersensitivity reactions such as angioedema, rash, urticaria
Anafylaktiske reaktioner, toksisk epidermal nekrolyse,, nekrotiserende angitis (vasculitis, kutan vasculitis), kutan lupus erythematosus- lignende reaktioner, reaktivering af kutan lupus erythematosus, fotosensitivitetsreaktioner, udslæt, urticaria
Skin and subcutaneous tissue disorders: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
37 4. 9 Overdosering
37 4.9 Overdose
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
The addition of 12.5 mg hydrochlorothiazide to
38 laveste måling (24 timer efter dosis) på 6, 1 mmHg.
38 300 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 BMS 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 BMS 150 mg/ 12.5 mg were 100%.
47, 2% af patienterne i kombinationsbehandling nåede et
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan
39 dal- SeDBT < 90 mmHg sammenlignet med 33, 2% af patienterne behandlet med irbesartan (p = 0, 0005).
39 (p = 0.0005).
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/ moderat cirrhose.
40 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
41 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
3 år.
6.3 Shelf life 3 years.
Kartoner med 14 tabletter; 1 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 28 tabletter; 2 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 56 tabletter; 4 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 84 tabletter; 6 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 98 tabletter; 7 blisterkort med 14 tabletter i PVC/ PVDC/ aluminiumblistere Kartoner med 56 x 1 tablet; 7 blisterkort med 8 x 1 tablet i PVC/ PVDC/ perforerede aluminiumblistere med enkeltdosis.
Cartons of 56 x 1 film-coated tablets; 7 blister cards of 8 x 1 film-coated tablets each in PVC/ PVDC/ Aluminium perforated unit dose blisters.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12, 5 mg filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 12.5 mg film-coated tablets.
89, 5 mg lactosemonohydrat per filmovertrukken tablet.
89.5 mg of lactose monohydrate per film-coated tablet.
44 Leverfunktionsnedsættelse:
44 Hepatic impairment:
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin- angiotensinsystemet.
45 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
46 Graviditet:
46 Pregnancy:
47 farmakokinetik er ikke evalueret.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
48 Der er kendt at behandling med AIIRAer under anden og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets knogledannelse) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
AIIRAs 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).
49 Sygdomme i bevægeapparatet, bindevæv og knogler:
49 Musculoskeletal, connective tissue and bone disorders:
51 4. 9 Overdosering
51 4.9 Overdose
52 laveste måling (24 timer efter dosis) på 6, 1 mmHg.
52 300 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.
53 dal- SeDBT < 90 mmHg sammenlignet med 33, 2% af patienterne behandlet med irbesartan (p = 0, 0005).
53 (p = 0.0005).
Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/ moderat cirrhose.
54 Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Selvom der er fundet modstridende resultater vedrørende genotoksisk eller karcinogen effekt, har det, på trods af et stort humant materiale, ikke været muligt at påvise en sammenhæng mellem anvendelse af hydrochlorthiazid og en stigning i antallet af neoplasmer.
55 Hydrochlorothiazide: although equivocal evidence for a genotoxic or carcinogenic effect was found in some experimental models, the extensive human experience with hydrochlorothiazide has failed to show an association between its use and an increase in neoplasms.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg filmovertrukne tabletter.
Irbesartan Hydrochlorothiazide BMS 300 mg/ 25 mg film-coated tablets.
53, 3 mg lactosemonohydrat per filmovertrukken tablet.
53.3 mg of lactose monohydrate per film-coated tablet.
58 Leverfunktionsnedsættelse:
58 Hepatic impairment:
Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin- angiotensinsystemet.
59 Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
60 Graviditet:
60 Pregnancy:
61 farmakokinetik er ikke evalueret.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.