natgillin/translations-raw huggingface dataset:
Styrke 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
Strength 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
Lægemiddelform Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Packaging Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Pakningsstørrelse 7 tabletter 14 tabletter 28 tabletter 30 tabletter 56 tabletter 90 tabletter 98 tabletter 280 tabletter 7 tabletter 14 tabletter 28 tabletter 30 tabletter 56 tabletter 90 tabletter 98 tabletter 280 tabletter 7 tabletter 14 tabletter 28 tabletter 30 tabletter 56 tabletter 90 tabletter 98 tabletter 280 tabletter 56 x 1 tablet (enhedsdosis) 98 x 1 tablet (enhedsdosis) 280 x 1 tablet (enhedsdosis) 56 x 1 tablet (enhedsdosis) 98 x 1 tablet (enhedsdosis) 280 x 1 tablet (enhedsdosis) 56 x 1 tablet (enhedsdosis) 98 x 1 tablet (enhedsdosis) 280 x 1 tablet (enhedsdosis) 280 tabletter (4 x 70) 280 tabletter (4 x 70) 280 tabletter (4 x 70)
Package size 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
Copalia 5 mg/ 80 mg filmovertrukne tabletter
Copalia 5 mg/ 80 mg film-coated tablets
Mørkegul, rund filmovertrukket tablet med facetslebne kanter, præget med ” NVR ” på den ene side og ” NV ” på den anden side.
Dark yellow, round film-coated tablet with bevelled edges, imprinted with “ NVR” on one side and “ NV” on the other side.
Copalia er indiceret til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin eller valsartan monoterapi.
Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Copalia 5 mg/ 80 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 80 mg alene.
Copalia 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Det anbefales at foretage individuel dosistitrering med de enkelte komponenter (dvs. amlodipin og valsartan), inden der skiftes til den faste kombination.
Individual dose titration with the components (i. e. amlodipine and valsartan) is recommended before changing to the fixed dose combination.
Patienter, som får valsartan og amlodipin fra hver sin tablet/ kapsel, kan for nemhedens skyld skifte til Copalia med den samme dosis af hver komponent.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Copalia containing the same component doses.
Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion.
Renal impairment No dosage adjustment is required for patients with mild to moderate renal impairment.
4. 4).
Hepatic impairment Caution should be exercised when administering Copalia to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Den maximale anbefalede dosis til patienter med mildt til moderat nedsat leverfunktion uden cholestase er 80 mg valsartan.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
Ældre (65 år eller derover) Der skal udvises forsigtighed, når dosis øges til ældre patienter.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
2 Børn og unge Copalia bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
2 Children and adolescents Copalia is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Overfølsomhed over for de aktive stoffer, over for dihydropyridinderivater eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients.
Alvorligt nedsat leverfunktion, biliær cirrhose eller cholestase.
Severe hepatic impairment, biliary cirrhosis or cholestasis.
Alvorligt nedsat nyrefunktion (GFR < 30 ml/ min/ 1, 73 m2) og patienter i dialysebehandling.
Severe renal impairment (GFR < 30 ml/ min/ 1.73 m2) and patients undergoing dialysis.
4. 4 og 4. 6).
Second and third trimesters of pregnancy (see section 4.4 and 4.6).
Graviditet Behandling med angiotensin II- antagonister (AIIA) bør ikke påbegyndes under graviditet.
Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
4. 3 og 4. 6).
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6).
Patienter med natrium - og/ eller væskemangel Under placebokontrollerede undersøgelser blev der set udtalt hypotension hos 0, 4% af patienterne med ukompliceret hypertension, som blev behandlet med Copalia.
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Copalia in placebo-controlled studies.
Symptomatisk hypotension kan forekomme hos patienter med et aktiveret renin- angiotensin- system (f. eks. patienter med væske - og/ eller natrium mangel, der får høje doser af diuretika), som behandles med angiotensin - receptorblokkere.
In patients with an activated renin-angiotensin system (such as volume- and/ or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur.
Hvis der forekommer hypotension med Copalia, skal patienten placeres i liggende rygstilling, og om nødvendigt skal der gives intravenøs infusion af normalt saltvand.
If hypotension occurs with Copalia, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Hyperkaliæmi Samtidig brug af kaliumtilskud, kaliumbesparende diuretika, kaliumholdige salterstatninger eller anden medicin, som øger indholdet af kalium (heparin osv.), skal foretages med forsigtighed og under hyppig monitoriering af kaliumniveauet.
Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be undertaken with caution and with frequent monitoring of potassium levels.
Nyrearteriestenose Der er ingen tilgængelige data om brug af Copalia til patienter med bilateral nyrearteriestenose eller stenose i en enkelt nyre.
Renal artery stenosis No data are available on the use of Copalia in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Nyretransplantation På nuværende tidspunkt er der ingen erfaring med sikkerheden ved brug af Copalia til patienter, som kort tid forinden har modtaget nyretransplantation.
Kidney transplantation To date there is no experience of the safe use of Copalia in patients who have had a recent kidney transplantation.
Nedsat leverfunktion Valsartan udskilles hovedsageligt via galden, mens amlodipin i udtalt grad metaboliseres i leveren.
Hepatic impairment Valsartan is mostly eliminated unchanged via the bile, whereas amlodipine is extensively metabolised by the liver.
Der bør udvises særlig forsigtighed, når Copalia gives til patienter med mildt til moderat nedsat leverfunktion eller biliære obstruktive lidelser.
Particular caution should be exercised when administering Copalia to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
3 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Primær hyperaldosteronisme Patienter med primær hyperaldosteronisme bør ikke behandles med angiotensin II- antagonisten, valsartan, da deres renin- angiotensin- system er påvirket af den primære lidelse.
3 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Hjertesvigt Som konsekvens af hæmningen af renin- angiotensin- aldosteron- systemet kan der sandsynligvis forekomme ændringer i nyrefunktionen hos særligt udsatte patienter.
Heart failure As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Hos patienter med alvorligt hjertesvigt, hvis nyrefunktion afhænger af renin- angiotensin- aldosteron- systemets aktivitet, er behandling med angiotensin- konverterende enzymhæmmere (ACE- hæmmere) og angiotensin - receptorantagonister blevet forbundet med oliguri og/ eller progressiv azotæmi og (sjældent) med akut nyresvigt og/ eller død.
In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/ or progressive azotaemia and (rarely) with acute renal failure and/ or death.
Dette til trods for, at der ikke var signifikant forskel i forekomsten af forværret hjerteinsufficiens sammenlignet med placebo.
In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Aorta - og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som med alle andre vasodilatorer skal der udvises særlig forsigtighed over for patienter, der lider af aorta - eller mitralklapstenose eller obstruktiv hypertrofisk kardiomyopati.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Interaktioner forbundet med amlodipin Forsigtighed ved samtidig brug CYP3A4- hæmmere Et studie med ældre patienter har vist, at diltiazam hæmmer metabolismen af amlodipin, sandsynligvis via CYP3A4 (plasmakoncentration forhøjes med ca 50% og virkningen af amlodipin er øget).
Interactions linked to amlodipine Caution required with concomitant use CYP3A4 inhibitors A study in elderly patients has shown that diltiazem inhibits the metabolism of amlodipine, probably via CYP3A4 (plasma concentration increases by approximately 50% and the effect of amlodipine is increased).
Det kan ikke udelukkes, at mere potente CYP3A4- hæmmere (f. eks. ketoconazol, itraconazol, ritonavir) kan forhøje plasmakoncentrationen af amlodipin i et større omfang end diltiazam.
The possibility that more potent inhibitors of CYP3A4 (i. e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine to a greater extent than diltiazem cannot be excluded.
CYP3A4- inducerende stoffer (antikrampemidler [f. eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon], rifampicin, Hypericum perforatum) Samtidig brug kan føre til nedsat plasmakoncentration af amlodipin.
CYP3A4 inducers (anticonvulsant agents [e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Co-administration may lead to reduced plasma concentrations of amlodipine.
Klinisk monitorering er indiceret, og det kan være nødvendigt at dosisjustere amlodipin under og efter behandling med inducerende stoffer.
Clinical monitoring is indicated, with possible dosage adjustment of amlodipine during the treatment with the inducer and after its withdrawal.
Bør tages i betragtning ved samtidig brug Andet Ved monoterapi har amlodipin været administreret sikkert sammen med thiazid diuretika, betablokkere, ACE- hæmmere, langtidsvirkende nitrater, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, antacida (aluminiumhydroxid gel, magnesiumhydroxid, simeticon), cimetidin, non- steroid- anti- inflammatorisk medicin, antibiotika og orale antidiabetika.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
4 Interaktioner forbundet med valsartan Samtidig brug frarådes Lithium Der er rapporteret reversible øgede serumkoncentrationer og toksicitet af lithium ved samtidig brug af ACE- hæmmere.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
4. 4).
If the combination proves necessary, careful monitoring of serum lithium levels is recommended (see section 4.4).
Kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller anden medicin, som øger kaliumniveauet Hvis der i kombination med valsartan udskrives et lægemiddel, som påvirker kaliumniveauet, bør kaliumindholdet i plasma monitoreres.
4 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Forsigtighed ved samtidig brug Non- steroid- anti- inflammatorisk medicin (NSAID), inklusive selektive COX- 2 hæmmere, acetylsalicylsyre (> 3 g/ dag) og ikke- selektive NSAID Når angiotensin II- antagonister gives samtidig med NSAID, kan der opstå svækkelse af den antihypertensive virkning.
Caution required with concomitant use Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur.
Yderligere kan samtidig brug af angiotensin II- antagonister og NSAID føre til øget risiko for forværring af nyrefunktionen samt en øgning af serumkalium.
Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Andet Der er ikke fundet klinisk signifikante interaktioner mellem valsartan monoterapi og følgende stoffer: cimetidin, warfarin, furosemid, digoxin, atenolol, indometacin, hydrochlorthiazid, amlodipin og glibenclamid.
Others In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Almindelige interaktioner med kombinationen Der er ikke udført interaktionsundersøgelser med Copalia og andre lægemidler.
Interactions common to the combination No drug interaction studies were performed with Copalia and other medicinal products.
Bør tages i betragtning ved samtidig brug Andre antihypertensive stoffer Almindelige anvendte antihypertensive stoffer (f. eks. alfablokkere, diuretika) og andre lægemidler, som kan forårsage hypotensive bivirkninger (f. eks. tricykliske antidepressiva, alfablokkere til behandling af benign prostata hyperplasi) kan øge kombinationens antihypertensive virkning.
To be taken into account with concomitant use Other antihypertensive agents Commonly used antihypertensive agents (e. g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e. g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Det frarådes at bruge angiotensin II- antagonister (AIIA) under første trimester af graviditet (se pkt.
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
4. 3 og 4. 4).
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see section 4.3 and 4.4).
En lille forøget risiko kan dog 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.
Der er ingen kontrollerede epidemiologiske data angående risikoen ved brug af angiotensin II- antagonister (AIIA), men lignende risici kan eksistere for denne gruppe af lægemidler.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Medmindre fortsat behandling med AIIA vurderes til at være nødvendig, bør patienter, som planlægger at blive gravide, skiftes til en alternativ hypertensionsbehandling med en dokumenteret sikkerhedsprofil til brug ved graviditet.
Unless continued AIIRA 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 konstateret graviditet skal behandlingen med AIIA afbrydes med det samme, og om nødvendigt skal en anden behandling påbegyndes.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, an, if appropriate, alternative therapy should be started.
5. 3).
AIIRAs therapy exposure 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) (see also section 5.3).
5 Det anbefales at udføre ultralydsscanning for at tjekke nyrefunktionen og kraniet, hvis fosteret har været udsat for AIIA fra andet trimester.
Should exposure to AIIRAs 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 AIIRAs should be closely observed for hypotension (see section 4.3 and 4.4).
Der er ingen erfaring med brug af Copalia til gravide kvinder.
There is no experience on the use of Copalia in pregnant women.
Dyreforsøg indikerer, at kombinationen af valsartan/ amlodipin har reproduktionstoksicitet på linie med det, der er beskrevet for valsartan og andre angiotensin II- antagonister (se pkt.
Data on a limited number of exposed pregnancies
Data fra et begrænset antal graviditeter, hvorunder amlodipin eller andre calciumantagonister blev brugt, indikerer ingen utilsigtede hændelser for fosterets helbred.
5 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Det vides ikke, om valsartan og/ eller amlodipin udskilles i human modermælk.
It is not known whether valsartan and/ or amlodipine are excreted in human milk.