natgillin/translations-raw huggingface dataset:
ACE-hæmmere og angiotensin-II-receptorblokkere bør derfor ikke anvendes samtidig hos patienter med diabetisk nefropati.
ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
Nedsat nyrefunktion og nyretransplantation: Når CoAprovel anvendes til patienter med nedsat nyrefunktion, anbefales periodisk monitorering af serum-kalium, serum-kreatinin og serum-urinsyreniveauer.
Renal impairment and kidney transplantation: when CoAprovel is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - Frankrig
SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel 37100 Tours - France
Hyppigheden af nedenstående bivirkninger er angivet på følgende måde: Almindelig: kan påvirke op til 1 ud af 10 patienter Ikke almindelig: kan påvirke op til 1 ud af 100 patienter
The frequency of the side effects listed below is defined using the following convention: Common: may affect up to 1 in 10 people
AIIRAer bør ikke anvendes under graviditetens første trimester (se pkt.
The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
Tabel 2 og 3 viser bivirkningerne af de individuelle stoffer i CoAprovel.
Tables 2 and 3 below detail the adverse reactions reported with the individual components of CoAprovel.
Dosisjustering af CoAprovel til ældre personer er ikke nødvendig.
No dosage adjustment of CoAprovel is necessary in older people.
Derudover reducerer thiazider nyreclearance af lithium og dermed øges risikoen for lithium toksicitet ved behandling med CoAprovel.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with CoAprovel.
Anvendelsen af AIIRA er kontraindiceret under graviditetens anden og tredje trimester (se pkt.
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Der er ikke set tegn på teratogen effekt hos rotter, der fik kombination af irbesartan og hydrochlorthiazid i doser, som forårsager maternel toksicitet.
No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
Calciumsalte: Thiaziddiuretika kan øge serum-calcium niveauet på grund af nedsat udskillelse.
Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Der er ingen klinisk erfaring med CoAprovel hos patienter med nedsat leverfunktion.
There is no clinical experience with CoAprovel in patients with hepatic impairment.
Denne faste dosiskombination er indiceret til voksne patienter, hvis blodtryk ikke kan reguleres adækvat med irbesartan eller hydrochlorthiazid alene (se pkt.
This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Elektrolytforstyrrelser: Som for alle patienter i diuretisk behandling, skal der med passende mellemrum foretages periodisk kontrol af serum-elektrolytter.
Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Hjælpestoffer: indeholder også lactosemonohydrat.
Excipients: also contains lactose monohydrate.
Forbigående sløret syn, xanthopsia, akut myopi og sekundært snævervinklet glaukom
transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Da der ikke foreligger oplysninger om anvendelse af CoAprovel under amning, frarådes brugen af CoAprovel, og andre behandlinger med en mere veletableret sikkerhedsprofil for anvendelse under amning foretrækkes.
Because no information is available regarding the use of CoAprovel during breast-feeding, CoAprovel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Yderligere information om irbesartaninteraktioner: Irbesartans farmakokinetik er i kliniske forsøg ikke blevet påvirket af hydrochlorthiazid.
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Synkope, hypotension, takykardi, ødem
syncope, hypotension, tachycardia, oedema
Det reproduktive system og mammae:
Reproductive system and breast disorders:
Forudgående behandling med store doser diuretika kan resultere i hypovolæmi og risiko for hypotension, når der påbegyndes behandling med irbesartan med eller uden thiaziddiuretika (se pkt.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4).
Irbesartan hæmmer ikke ACE (kininase-II), et enzym som producerer angiotensin-II og også nedbryder bradykinin til inaktive metabolitter.
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Blandt 898 hypertensive patienter, der fik forskellige doser af irbesartan/hydrochlorthiazid (interval: 37,5 mg/6,25 mg til 300 mg/25 mg) i placebokontrollerede forsøg, oplevede 29,5% af patienterne bivirkninger.
Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions.
Ved konstateret graviditet, bør behandling med AIIRAer seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt bør anden behandling iværksættes.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Der fås også enkeltdosisblisterpakninger med 56 x 1 tablet til hospitalsbrug.
Unit dose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Titaniumdioxid (E 171) Macrogol 3000
Titanium dioxide Macrogol 3000
Aplastisk anæmi, knoglemarvsdepression, neutropeni/agranulocytose, hæmolytisk anæmi, leukopeni, trombocytopeni
aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
14 tabletter 28 tabletter 56 tabletter 56 x 1 tabletter 98 tabletter
14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige saltsubstitutioner skal derfor gives med forsigtighed sammen med CoAprovel (se pkt.
Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with CoAprovel (see section 4.5).
14 tabletter 28 tabletter 30 tabletter 56 tabletter 56 x 1 tabletter 84 tabletter 90 tabletter 98 tabletter
14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
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 forcetitrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Bivirkninger forbundet med hydrochlorthiazid alene Appetitmangel; maveirritation; mavekramper; forstoppelse; gulsot (hvor huden og/eller det hvide i øjnene bliver gulfarvet); bugspytkirtelbetændelse, med stærke smerter i øvre maveregion, ofte forbundet med kvalme og opkastning; søvnproblemer; depression; sløret syn; mangel på hvide blodceller, som kan resultere i hyppige infektioner; feber; nedsat antal blodplader (blodceller, som er nødvendige for, at blodet kan størkne); nedsat antal af røde blodceller (blodmangel), som karakteriseres ved træthed, hovedpine, forpustethed ved motion, svimmelhed og bleghed; nyresygdom; lungeproblemer, inklusive lungebetændelse eller ophobning af væske i lungerne; øget følsomhed af huden for sol; årebetændelse; hudsygdom som karakteriseres ved afskalning af huden over hele kroppen; kutan lupus erythematosus, som ses i form af udslæt i ansigt, hals og hovedbund; allergiske reaktioner; svækkelse og muskelkramper; ændring i puls; nedsat blodtryk efter ændringer i kropsstilling; hævelse af spytkirtler; højt sukkerindhold i blodet; sukker i urinen; øgning i bestemte typer af fedt i blod; høj mængde urinsyre i blodet, som kan lede til urinsyregigt.
Side effects associated with hydrochlorothiazide alone Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
På grund af hydrochlorthiazid-komponenten anbefales CoAprovel ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/min).
Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Stort forbrug af hydrochlorthiazid (≥ 50.000 mg kumulativt) var forbundet med en justeret OR-værdi på 1,29 (95 %KI: 1,23-1,35) for basalcellekarcinom og på 3,98 (95 %-KI: 3,68-4,31) for pladecellekarcinom.
High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.231.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Samtidig administration af thiaziddiuretika kan øge hyppigheden af overfølsomhedsreaktioner over for allupurinol;
Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
CoAprovel er ikke indiceret til patienter med svært nedsat leverfunktion.
CoAprovel is not indicated in patients with severe hepatic impairment.
Den selektive antagonisme mod angiotensin-II (AT1) receptorerne resulterer i en forhøjelse af plasma-renin- og angiotensin-IIniveauerne og i nedsat aldosteron i plasma.
The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
CoAprovel indeholder en kombination af to aktive lægemidler, irbesartan og hydrochlorthiazid.
CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide.
Sjældne tilfælde af overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
cases of hypersensitivity reactions such as angioedema, rash, urticaria
Du skal også oplyse lægen om det: hvis du er på en saltfattig diæt hvis du har symptomer som voldsom tørst, mundtørhed, følelse af svaghed, sløvhed, muskelsmerter eller -kramper, kvalme, opkastning eller en voldsom hjertebanken, som kan være tegn på for kraftig effekt af hydrochlorthiazid (der er indeholdt i CoAprovel) hvis du oplever øget følsomhed af huden for sol med solskoldningssymptomer (såsom rødme, kløe, hævelse, blæredannelse), som forekommer hurtigere end normalt hvis du skal opereres eller bedøves hvis dit syn ændrer sig, eller du får smerter i et af eller begge dine øjne, mens du tager CoAprovel.
You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in CoAprovel) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking CoAprovel.
Interstitiel nefritis, nyreinsufficiens
interstitial nephritis, renal dysfunction
Kommissionens afgørelse
At the time of Commission Decision.
Kombinationen af 300 mg irbesartan og 12,5 mg hydrochlorthiazid medførte en total placebo-korrigeret systolisk/diastolisk reduktion på op til 13,6/11,5 mmHg.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mm Hg.
Lægemidler, der påvirkes af serum-kaliumforstyrrelser: Det anbefales at måle serum-kalium periodisk, når CoAprovel 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 CoAprovel is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
ACE-hæmmere og angiotensin-II-receptorblokkere bør ikke amvendes samtidig hos patienter med diabetisk nefropati.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
NDMA Grænseværdi i ppm i det aktive stof
NDEA Limit in ppm in API
Hvis der er givet AIIRAer under graviditetens andet trimester, anbefales ultralydskontrol af nyrefunktionen og kraniet.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Abnorm vandladning
abnormal urination
14 - 28 - 56 - 84 - 98 tabletter: Ma
14 - 28 - 56 - 84 - 98 tablets: Mon
Generelt: Hos patienter, hvis vaskulære tonus og nyrefunktion hovedsageligt afhænger af reninangiotensin-aldosteronsystemets aktivitet (fx patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inklusive nyrearteriestenose), er behandling med angiotensinkonverterende enzymhæmmere eller angiotensin-II receptorantagonister, der påvirker dette system, blevet forbundet med akut hypotension, azotæmi, oliguri og i sjældne tilfælde akut nyresvigt (se pkt.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Anvendelse af CoAprovel i ammeperioden frarådes.
The use of CoAprovel during breast feeding is not recommended.
Lægemidler, der påvirker kalium: Den kalium-depleterende virkning af hydrochlorthiazid dæmpes af irbesartans kalium-besparende effekt.
Medicinal products affecting potassium: the potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Hos patienter, der ikke var tilstrækkeligt kontrolleret med 25 mg hydrochlorthiazid alene, gav et tillæg af irbesartan en yderligere placebo-korrigeret systolisk/diastolisk gennemsnitlig reduktion på 11,1/7,2 mmHg.
In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mm Hg.
Risikofaktorer for at udvikle akut snævervinklet glaukom kan omfatte allergi over for sulfonamider eller antibiotika i anamnesen (se pkt.
Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8).
Følgende ændringer, observeret hos rotter og makakaber, der fik en kombination af irbesartan/hydrochlorthiazid på 10/10 og 90/90 mg/kg/dag, blev også set ved anvendelse af de individuelle stoffer og/eller var sekundære til blodtryksnedsættelse (der blev ikke observeret signifikante toksikologiske interaktioner):  nyreforandringer karakteriseret ved let øgning af serum-urea og kreatinin samt hyperplasi/hypertrofi af det juxtaglomerulære apparat, hvilket er en direkte konsekvens af interaktion mellem irbesartan og renin-angiotensin-systemet;  let fald i erytrocytparametre (erytrocytter, hæmoglobin, hæmatokrit);  i et 6 måneders toksicitetsstudie med irbesartan 90 mg/kg/dag, hydrochlorthiazid 90 mg/kg/dag, og irbesartan/hydrochlorthiazid 10/10 mg/kg/dag blev der observeret misfarvning, sår og fokal nekrose af ventrikelslimhinden hos rotter.
The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Lægemidler mod arthritis urica: Det kan være nødvendigt at justere dosis af lægemidler mod arthritis urica, da hydrochlorthiazid kan øge niveauet af urinsyre i serum.
Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Dobbelt hæmning af renin-angiotensin-aldosteron-systemet (RAAS): Der er evidens for, at samtidig brug af ACE-hæmmere, angiotensin-II-receptorblokkere eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsætter nyrefunktionen (inklusive akut nyresvigt).
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Dobbelt hæmning af RAAS ved kombination af ACE-hæmmere, angiotensin-II-receptorblokkere eller aliskiren anbefales derfor ikke (se pkt.
Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
14 - 28 - 56 - 98 tabletter: Ma
14 - 28 - 56 - 98 tablets: Mon
Nervesystemet:
Nervous system disorders:
Sådan skal du tage CoAprovel
How to take CoAprovel
Renal arteriestenose - renovaskulær hypertension: Der er øget risiko for alvorlig hypotension og nyreinsufficiens, hvis patienter med bilateral nyrearteriestenose eller stenose af arterien til den eneste fungerende nyre behandles med angiotensin-konverterende enzymhæmmere eller angiotensin-II receptor-antagonister.
Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
Tabel 1: Bivirkninger fra placebokontrollerede studier, og bivirkninger rapporteret efter markedsføring
Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports
Psykiske forstyrrelser:
Psychiatric disorders:
Det bør overvejesat monitorere nyrefunktionen efter samtidig behandling er initieret og periodisk derefter.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Grænseværdi (ng/dag)
NDEA Limit in ng/day
Højere doser end 300 mg irbesartan/25 mg hydrochlorthiazid, 1 gang dagligt frarådes.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Derfor frarådes kombination af lithium og CoAprovel (se pkt.
Therefore, the combination of lithium and CoAprovel is not recommended (see section 4.4).
Kombinationen af disse stoffer medfører en større reduktion af blodtrykket end der opnås med hver komponent alene.
The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Der er indberettet bivirkninger efter markedsføring af CoAprovel.
Side effects reported since the launch of CoAprovel Some undesirable effects have been reported since marketing of CoAprovel.
Det er kendt, at eksponering for behandling med AIIRA under andet og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets ossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Bivirkninger, hvor hyppigheden ikke er kendt, er: hovedpine, ringen for ørerne, hoste, smagsforstyrrelser, forstoppelse, led- og muskelsmerter, leversygdom og nedsat nyrefunktion, øget mængde af kalium i blodet og allergiske reaktioner såsom udslæt, nældefeber,opsvulmet ansigt, læber, mund, tunge og hals.
Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Luftveje, thorax og mediastinum:
Respiratory, thoracic and mediastinal disorders:
(Du bør heller ikke tage CoAprovel i begyndelsen af graviditeten - se afsnittet om graviditet) hvis du har alvorlige lever- eller nyreproblemer (spørg lægen, hvis du er i tvivl) hvis du har problemer med urinproduktionen hvis din læge har konstateret, at du har konstant forhøjet calcium eller lavt kalium i blodet hvis du har diabetes eller nedsat nyrefunktion, og du bliver behandlet med et lægemiddel, der sænker blodtrykket, som indeholder aliskiren.
(It is also better to avoid CoAprovel in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Doping-test: Indholdet af hydrochlorthiazid i dette lægemiddel kan medføre et positivt fund ved en Doping-test.
Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.