FrancophonIA/ELRC3.0 huggingface dataset:
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet, skal behandling med AIIRA'ere seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt skal anden behandling iværksættes.
English: Not known: weakness, muscle spasm
Danish: Ikke kendt: svækkelse, muskelspasmer
English: The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
Danish: De dosisafhængige bivirkninger med hydrochlorthiazid (specielt elektrolytforstyrrelser) kan øges ved anvendelse af højere dosis hydrochlorthiazid.
English: (It is also better to avoid Ifirmacombi 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
Danish: (Du bør heller ikke tage Ifirmacombi i begyndelsen af graviditeten -se afsnittet om graviditet) hvis du har alvorlige lever-eller nyreproblemer 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 sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren
English: Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5).
Danish: Serum-kalium påvirkes ikke nævneværdigt, når irbesartan administreres alene ved de anbefalede doser til patienter uden risiko for udvikling af elektrolytforstyrrelser (se pkt.
English: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Danish: Ikke kendt: pankreatitis, anoreksi, diarré, obstipation, maveirritation, sialadenitis, appetitløshed
English: Side effects associated with hydrochlorothiazide alone Skin and lip cancer (non-melanoma skin cancer); 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 buildup 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.
Danish: Bivirkninger forbundet med hydrochlorthiazid alene Hud-og læbekræft (non-melanom hudkræft); appetitmangel; maveirritation; mavekramper; forstoppelse; gulsot (hvor hud og/eller det hvide i øjne bliver farvet gul); betændelse i bugspytkirtlen med stærke smerter i øvre maveregion, ofte forbundet med kvalme og opkastning; søvnproblemer; depression; sløret syn; mangel på hvide blodlegemer, som kan resultere i hyppige infektioner; feber; nedsat antal blodplader (blodlegemer, som er nødvendige for, at blodet kan størkne); nedsat antal af røde blodlegemer (blodmangel), som karakteriseres ved træthed, hovedpine, forpustethed ved motion, svimmelhed og bleghed; nyresygdom; lungeproblemer, inklusive lungebetændelse eller ophobning afvæske 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; hævede spytkirtler;
English: 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 mmHg.
Danish: 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.
English: Not known: transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Danish: Ikke kendt: forbigående sløret syn, xantopsi, akut myopi og sekundært snævervinklet glaukom
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports Investigations
Danish: Tabel 1: Bivirkninger fra placebokontrollerede studier, og bivirkninger rapporteret efter markedsføring
English: Thiazide therapy may impair glucose tolerance.
Danish: Thiazidbehandling kan svække glucosetolerancen.
English: Uncommon side effects (may affect up to 1 in 100 people): - diarrhoea - low blood pressure - fainting - heart rate increased - flushing - swelling - sexual dysfunction (problems with sexual performance) - blood tests may show lowered levels of potassium and sodium in your blood.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 patienter) diarré lavt blodtryk besvimelse hjertebanken rødmen hævelse seksuelle problemer blodprøver kan vise nedsat indhold af kalium og natrium i blodet.
English: A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Danish: Forud for planlagt graviditet skal der skiftes til anden passende behandling.
English: The use of Ifirmacombi during breast feeding is not recommended.
Danish: Anvendelse af Ifirmacombi i ammeperioden frarådes.
English: Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Danish: Der kan forekomme hyperurikæmi, eller regulær urinsyregigt kan blive fremprovokeret hos visse patienter i thiazidbehandling.
English: Uncommon syncope, hypotension, tachycardia, oedema
Danish: Ikke almindelig: synkope, hypotension, takykardi, ødem
English: Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Danish: Digitalisglykosider: thiazidinduceret hypokaliæmi eller hypomagnesiæmi øger forekomsten af digitalisinducerede kardielle arytmier (se pkt.
English: Acute Myopia and Secondary Acute Angle-Closure Glaucoma:
Danish: Akut myopi og sekundært snævervinklet glaukom:
English: Common: Not known abnormal urination impaired renal function including isolated cases of renal failure in patients at risk (see section 4.4)
Danish: abnorm vandladning nedsat nyrefunktion inklusive isolerede tilfælde af nyresvigt hos risikopatienter (se pkt.
English: 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 mmHg.
Danish: Tillæg af 12,5 mg hydrochlorthiazid til 300 mg irbesartan 1 gang dagligt hos patienter, der ikke var adækvat behandlede med 300 mg irbesartan alene, medførte en yderligere placebo-korrigeret diastolisk blodtryksreduktion ved laveste måling (24 timer efter dosis) på 6,1 mmHg.
English: Not known: interstitial nephritis, renal dysfunction
Danish: Ikke kendt: interstitiel nefritis, nyreinsufficiens
English: Aliskiren-containing products or ACE-inhibitors:
Danish: Aliskiren-holdige lægemidler og ACE-hæmmere:
English: Medicinal products affecting potassium:
Danish: Lægemidler, der påvirker kalium:
English: Not known: Anaphylactic reaction including anaphylactic shock
Danish: Ikke kendt: Anafylaktisk reaktion/shock
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Ifirmacombi (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige saltsubstitutter skal gives med forsigtighed sammen med Ifirmacombi (se pkt.
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Danish: På grund af voldsom diurese medfører overdosis af hydrochlorthiazid elektrolytdepletering (hypokaliæmi, hypokloræmi, hyponatriæmi) og dehydrering.
English: Ifirmacombi contains sodium
Danish: Ifirmacombi indeholder natrium
English: Iron oxide, yellow (E172)
Danish: Jernoxid, gul (E172) Jernoxid, rød (E172)
English: These 24-hour effects were observed without excessive blood pressure lowering at peak and are consistent with safe and effective blood-pressure lowering over the once-daily dosing interval.
Danish: Disse 24-timers resultater blev observeret uden at der opstod overdreven reduktion af blodtrykket på det maksimale niveau.
English: Not known: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Danish: Ikke kendt: aplastisk anæmi, knoglemarvsdepression, neutropeni/agranulocytose, hæmolytisk anæmi, leukopeni, trombocytopeni
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis der er givet angiotensin II-receptor-antagonister under graviditetens andet trimester, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: The two active ingredients in Ifirmacombi work together to lower blood pressure further than if either was given alone.
Danish: Når de to aktive stoffer i Ifirmacombi gives samtidigt, bliver deres virkning på blodtrykket større, end hvis de blev givet hver for sig.
English: The hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Danish: Doping-test: Indholdet af hydrochlorthiazid i dette lægemiddel kan medføre et positivt fund ved en doping-test.
English: Therefore, the combination of lithium and Ifirmacombi is not recommended (see section 4.4).
Danish: Derfor frarådes kombination af lithium og Ifirmacombi (se pkt.
English: - if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - Aliskiren
Danish: Beskyt huden mod sollys og UVstråler, mens du tager Ifirmacombi hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: - en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyrerproblemer i forbindelse med sukkersyge - aliskiren
English: Ifirmacombi is not indicated in patients with severe hepatic impairment.
Danish: Ifirmacombi er ikke indiceret til patienter med svært nedsat leverfunktion.
English: When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebo-subtracted systolic/diastolic reductions of 15.8/10.0 mmHg.
Danish: Ved ambulant blodtrykskontrol medførte kombinationen af 150 mg irbesartan og 12,5 mg hydrochlorthiazid, 1 gang dagligt, en vedvarende blodtryksreduktion over en 24 timers periode med en gennemsnitlig 24 timers placebo-korrigeret systolisk/diastolisk reduktion på 15,8/10,0 mmHg.
English: If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
Danish: Ved hypotension lægges patienten i rygleje, og salt- og væsketilskud administreres straks.
English: Not known: cases of hypersensitivity reactions such as angioedema, rash, urticaria
Danish: Ikke kendt:sjældne tilfælde af overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Danish: Data fra kliniske studier har vist, at dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS) ved kombinationsbehandling med ACE-hæmmere, angiotensin II-receptorantagonister eller aliskiren, er forbundet med en højere hyppighed af bivirkninger som hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende lægemiddel (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicinsammen med Ifirmacombi Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Ifirmacombi 300 mg/25 mg film-coated tablets EU/1/11/673/017-024
Danish: Ifirmacombi 300 mg/25 mg filmovertrukne tabletter EU/1/11/673/017-024
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Danish: Som det er tilfældet med ACE-hæmmere, kan samtidig anvendelse af angiotensin-II-antagonister og NSAID'ere medføre øget risiko for forværring af nyrefunktionen, herunder muligt akut nyresvigt samt øgning af serum-kalium.
English: 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).
Danish: Faldet i SeSBT/SeDBT efter 5 uger var henholdsvis 30,8/24,0 mmHg og 21,1/19,3 mmHg for irbesartan/hydrochlorothiazid og irbesartan (p < 0,0001).
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Danish: Irbesartans farmakokinetik er i kliniske forsøg ikke blevet påvirket af hydrochlorthiazid.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Danish: Ved konstateret graviditet skal behandling med AIIRA seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt skal anden behandling iværksættes (se pkt.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Danish: Spædbørn, hvis mødre har taget angiotensin II-receptor-antagonister, skal observeres omhyggeligt for hypotension (se pkt.
English: Sodium:
Danish: Natrium:
English: Not known: vertigo, paraesthesia, light-headedness, restlessness
Danish: Ikke kendt: svimmelhed, paræstesier, uklarhed, rastløshed
English: Common side effects (may affect up to 1 in 10 people): - nausea/vomiting - abnormal urination - fatigue - dizziness (including when getting up from a lying or sitting position) - blood tests may show raised levels of an enzyme that measures the muscle and heart function
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter) kvalme/opkastning unormal vandladning træthed svimmelhed (også når man rejser sig fra liggende eller siddende stilling) blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinkinase) eller stigning i stoffer, som måler nyrefunktionen (carbamid, kreatinin).
English: Warnings and precautions Talk to your doctor before taking Ifirmacombi and if any of the following apply to you: - if you get excessive vomiting or diarrhoea - if you suffer from kidney problems or have a kidney transplant - if you suffer from heart problems - if you suffer from liver problems - if you suffer from diabetes - if you suffer from lupus erythematosus (also known as lupus or SLE) - if you suffer from primary aldosteronism (a condition related to high production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
Danish: Kontakt lægen, før du tager Ifirmacombi, hvis du oplever følgende: hvis du får hyppig opkastning eller diarré hvis du lider af nyreproblemer eller er nyretransplanteret hvis du lider af hjerteproblemer hvis du lider af leverproblemer hvis du lider af sukkersyge hvis du lider af erytematøs lupus (også kaldet lupus eller SLE) hvis du lider af primær aldosteronisme (tilstand med høj produktion af hormonet aldosteron, som gør, at der ophobes natriumsalt i kroppen, og blodtrykket derfor stiger) hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
English: No dosage adjustment of Ifirmacombi is necessary in older people.
Danish: Dosisjustering af Ifirmacombi til ældre patienter er ikke nødvendig.
English: Not known: hyperkalaemia
Danish: Ikke kendt: hyperkalæmi
English: Titanium dioxide (E171)
Danish: Polyvinylalcohol Titandioxid (E171) Macrogol
English: Ifirmacombi should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Danish: Ifirmacombi må ikke anvendes til patienter med alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/min) (se pkt.
English: No dosage adjustment of Ifirmacombi is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Danish: Dosisjustering af Ifirmacombi til patienter med let eller moderat leverfunktionsnedsættelse er ikke nødvendig (se pkt.
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets EU/1/11/673/009-016
Danish: Ifirmacombi 300 mg/12,5 mg filmovertrukne tabletter EU/1/11/673/009-016
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets EU/1/11/673/001-008
Danish: Ifirmacombi 150 mg/12.5 mg filmovertrukne tabletter EU/1/11/673/001-008
English: Not known: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Danish: 4.4), hyperurikæmi, glukosuri, hyperglykæmi, stigning i kolesterol og triglycerider
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Ifirmacombi 150 mg/12.5 mg and Ifirmacombi 300 mg/12.5 mg, respectively.
Danish: Forholdet mellem den laveste og den maksimale effekt var henholdsvis 68% og 76% for Ifirmacombi 150 mg /12,5 mg og Ifirmacombi 300 mg/12,5 mg, når virkningen blev målt med blodtryksmanchet ved kontrolbesøg.
English: Adequate monitoring of serum potassium in patients at risk is recommended (see section 4.4).
Danish: For risikopatienter anbefales passende monitorering af serum-kalium (se pkt.
English: The recommended dose of Ifirmacombi 300 mg/25 mg is one tablet a day.
Danish: Den anbefalede dosis af Ifirmacombi 300 mg/25 mg er én tablet dagligt.
English: The recommended dose of Ifirmacombi 150 mg/12.5 mg is one tablet a day.
Danish: Den anbefalededosis af Ifirmacombi 150 mg/12,5 mg er én tablet dagligt.
English: EU/1/11/673/017 (14 film-coated tablets) EU/1/11/673/018 (28 film-coated tablets) EU/1/11/673/019 (30 film-coated tablets) EU/1/11/673/020 (56 film-coated tablets) EU/1/11/673/021 (56 x 1 film-coated tablets) EU/1/11/673/022 (84 film-coated tablets) EU/1/11/673/023 (90 film-coated tablets) EU/1/11/673/024 (98 film-coated tablets)
Danish: EU/1/11/673/017 (14 filmovertrukne tabletter) EU/1/11/673/018 (28 filmovertrukne tabletter) EU/1/11/673/019 (30 filmovertrukne tabletter) EU/1/11/673/020 (56 filmovertrukne tabletter) EU/1/11/673/021 (56 x 1 filmovertrukne tabletter) EU/1/11/673/022 (84 filmovertrukne tabletter) EU/1/11/673/023 (90 filmovertrukne tabletter) EU/1/11/673/024 (98 filmovertrukne tabletter)
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
Danish: Dosering 1 gang dagligt med 150 mg irbesartan og 12,5 mg hydrochlorthiazid gav en systolisk/diastolisk gennemsnitlig placebojusteret blodtryksreduktion ved laveste måling (24 timer efter dosis) på 12,9/6,9 mmHg hos patienter med let til moderat hypertension.
English: EU/1/11/673/001 (14 film-coated tablets) EU/1/11/673/002 (28 film-coated tablets) EU/1/11/673/003 (30 film-coated tablets) EU/1/11/673/004 (56 film-coated tablets) EU/1/11/673/005 (56 x 1 film-coated tablets) EU/1/11/673/006 (84 film-coated tablets) EU/1/11/673/007 (90 film-coated tablets) EU/1/11/673/008 (98 film-coated tablets)
Danish: EU/1/11/673/001 (14 filmovertrukne tabletter) EU/1/11/673/002 (28 filmovertrukne tabletter) EU/1/11/673/003 (30 filmovertrukne tabletter) EU/1/11/673/004 (56 filmovertrukne tabletter) EU/1/11/673/005 (56 x 1 filmovertrukne tabletter) EU/1/11/673/006 (84 filmovertrukne tabletter) EU/1/11/673/007 (90 filmovertrukne tabletter) EU/1/11/673/008 (98 filmovertrukne tabletter)
English: 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.
Danish: Bivirkninger, hvor hyppigheden ikke er kendt, er: hovedpine ringen for ørerne (tinnitus) hoste smagsforstyrrelser forstoppelse led-og muskelsmerter leversygdom og nedsat nyrefunktion øget indhold af kalium i blodet og allergiske reaktioner såsom udslæt, nældefeber, opsvulmet ansigt, læber, mund, tunge og hals der er i sjældne tilfælde også indberettet gulsot (gulfarvning af huden og/eller det hvide i øjnene).
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Severe renal impairment (creatinine clearance < 30 ml/min) - Refractory hypokalaemia, hypercalcaemia - Severe hepatic impairment, biliary cirrhosis and cholestasis - The concomitant use of Ifirmacombi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5
Danish: 4.4 og 4.6) - Alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/min) - Refraktær hypokaliæmi, hyperkalcæmi - Alvorlig leverfunktionsnedsættelse, biliær cirrose og kolestase - Samtidig brug af Ifirmacombi og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: EU/1/11/673/009 (14 film-coated tablets) EU/1/11/673/010 (28 film-coated tablets) EU/1/11/673/011 (30 film-coated tablets) EU/1/11/673/012 (56 film-coated tablets) EU/1/11/673/013 (56 x 1 film-coated tablets) EU/1/11/673/014 (84 film-coated tablets) EU/1/11/673/015 (90 film-coated tablets) EU/1/11/673/016 (98 film-coated tablets)
Danish: EU/1/11/673/009 (14 filmovertrukne tabletter) EU/1/11/673/010 (28 filmovertrukne tabletter) EU/1/11/673/011 (30 filmovertrukne tabletter) EU/1/11/673/012 (56 filmovertrukne tabletter) EU/1/11/673/013 (56 x 1 filmovertrukne tabletter) EU/1/11/673/014 (84 filmovertrukne tabletter) EU/1/11/673/015 (90 filmovertrukne tabletter) EU/1/11/673/016 (98 filmovertrukne tabletter)
English: The recomended dose of Ifirmacombi 300 mg /12.5 mg is one tablet a day.
Danish: Den anbefalede dosis af Ifirmacombi 300 mg/12,5 mg er én tablet dagligt.