FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor before taking Irbesartan Hydrochlorothiazide Zentiva 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 Irbesartan Hydrochlorothiazide Zentiva, 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 systemisk lupus erythematosus) 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 tager en af følgende lægemidler, der anvendes til at behandle forhøjet blodtryk:
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
Danish: 6.1 eller over for andre sulfonamidderivater (hydrochlorthiazid er et sulfonamidderivat) Graviditet i 2. eller 3. trimester (se pkt.
English: Efficacy and safety of Irbesartan Hydrochlorothiazide Zentiva as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, doubleblind, active-controlled, 8-week, parallel-arm study.
Danish: Et randomiseret, dobbeltblindt, aktivt kontrolleret, parallelt multicenterforsøg af 8 ugers varighed har evalueret effekten og sikkerheden af Irbesartan Hydrochlorothiazide Zentiva som inital behandling ved svær hypertension (defineret som SeDBT ≥ 110 mmHg).
English: Titanium dioxide Macrogol 3000
Danish: Lactosemonohydrat Hypromellose Titaniumdioxid (E 171) Macrogol 3000
English: Lactose monohydrate Hypromellose
Danish: Croscarmellosenatrium Hypromellose Silica
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Danish: Hver tablet af Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tabletter indeholder 300 mg irbesartan og 25 mg hydrochlorthiazid.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter.
English: No dosage adjustment is necessary inolder people.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter.
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Danish: Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med mild til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min).
English: Irbesartan Hydrochlorothiazide Zentiva should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Danish: Zentiva må ikke anvendes til patienter med alvorlig nyrefunktionsnedsættelse (kreatininclearance < 30 ml/min) (se pkt.
English: Irbesartan Hydrochlorothiazide Zentiva is for oral use.
Danish: Irbesartan Hydrochlorothiazide Zentiva skal tages gennem munden.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva k.s.
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Danish: Hver tablet af Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter leveres i blisterpakninger á 14, 28, 56 eller 98 tabletter.
English: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Danish: Hver filmovertrukken tablet indeholder 38,5 mg lactose (som lactosemonohydrat).
English: Although not specifically studied with the Irbesartan Hydrochlorothiazide Zentiva, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Danish: Der er hverken observeret rebound-hypertension for irbesartan eller hydrochlorthiazid.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva k.s.
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min but <60 ml/min) this fixed dose combination should be administered with caution.
Danish: Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med mildt til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men < 60 ml/min).
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Zentiva k.s.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter er lyserød, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2788 på den anden side.
English: cardiac arrhythmias
Danish: Hyperkalæmi
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Danish: Hver tablet af Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: What Irbesartan Hydrochlorothiazide Zentiva is and what it is used for What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva How to take Irbesartan Hydrochlorothiazide Zentiva Possible side effects
Danish: Det skal du vide, før du begynder at tage Irbesartan Hydrochlorothiazide Zentiva Sådan skal du tage Irbesartan Hydrochlorothiazide Zentiva Bivirkninger
English: No dosage adjustment is necessary in patients with renal impairment whose creatinine clearance is ≥30 ml/min.
Danish: Dosisjustering er ikke nødvendig til patienter med nedsat nyrefunktion, hvis den renale kreatinin-clearance er  30 ml/min (se pkt.
English: EU/1/06/377/001 - 14 tablets EU/1/06/377/002 - 28 tablets EU/1/06/377/003 - 56 tablets EU/1/06/377/004 - 56 x 1 tablets EU/1/06/377/005 - 98 tablets
Danish: EU/1/06/377/001 - 14 tabletter EU/1/06/377/002 - 28 tabletter EU/1/06/377/003 - 56 tabletter EU/1/06/377/004 - 56 x 1 tabletter EU/1/06/377/005 - 98 tabletter
English: EU/1/06/377/006 - 14 tablets EU/1/06/377/007 - 28 tablets EU/1/06/377/008 - 56 tablets EU/1/06/377/009 - 56 x 1 tablets EU/1/06/377/010 - 98 tablets
Danish: EU/1/06/377/006 - 14 tabletter EU/1/06/377/007 - 28 tabletter EU/1/06/377/008 - 56 tabletter EU/1/06/377/009 - 56 x 1 tabletter EU/1/06/377/010 - 98 tabletter
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter.
English: EU/1/06/377/017 - 14 tablets EU/1/06/377/018 - 28 tablets EU/1/06/377/031 - 30 tablets EU/1/06/377/019 - 56 tablets EU/1/06/377/020 - 56 x 1 tablets EU/1/06/377/021 - 84 tablets EU/1/06/377/032 - 90 tablets EU/1/06/377/022 - 98 tablets
Danish: EU/1/06/377/017 - 14 tabletter EU/1/06/377/018 - 28 tabletter EU/1/06/377/031 - 30 tabletter EU/1/06/377/019 - 56 tabletter EU/1/06/377/020 - 56 x 1 tabletter EU/1/06/377/021 - 84 tabletter EU/1/06/377/032 - 90 tabletter EU/1/06/377/022 - 98 tabletter
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Danish: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: EU/1/06/377/011 - 14 tablets EU/1/06/377/012 - 28 tablets EU/1/06/377/029 - 30 tablets EU/1/06/377/013 - 56 tablets EU/1/06/377/014 - 56 x 1 tablets EU/1/06/377/015 - 84 tablets EU/1/06/377/030 - 90 tablets EU/1/06/377/016 - 98 tablets
Danish: EU/1/06/377/011 - 14 tabletter EU/1/06/377/012 - 28 tabletter EU/1/06/377/029 - 30 tabletter EU/1/06/377/013 - 56 tabletter EU/1/06/377/014 - 56 x 1 tabletter EU/1/06/377/015 - 84 tabletter EU/1/06/377/030 - 90 tabletter EU/1/06/377/016 - 98 tabletter
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter.
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: EU/1/06/377/023 - 14 tablets EU/1/06/377/024 - 28 tablets EU/1/06/377/033 - 30 tablets EU/1/06/377/025 - 56 tablets EU/1/06/377/026 - 56 x 1 tablets EU/1/06/377/027 - 84 tablets EU/1/06/377/034 - 90 tablets EU/1/06/377/028 - 98 tablets
Danish: EU/1/06/377/023 - 14 tabletter EU/1/06/377/024 - 28 tabletter EU/1/06/377/033 - 30 tabletter EU/1/06/377/025 - 56 tabletter EU/1/06/377/026 - 56 x 1 tabletter EU/1/06/377/027 - 84 tabletter EU/1/06/377/034 - 90 tabletter EU/1/06/377/028 - 98 tabletter
English: Lietuva Zentiva, k.s.
Danish: Sverige Zentiva, k.s.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter leveres i blisterpakninger af 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter.
English: 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):
Danish: 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);
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg were 100%.
Danish: Forholdet mellem den laveste og den maksimale effekt af Irbesartan Hydrochlorothiazide Zentiva 150 mg /12,5 mg var 100%, når blodtrykket blev monitoreret ambulant.
English: When necessary, Irbesartan Hydrochlorothiazide Zentiva may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Om nødvendigt kan Irbesartan Hydrochlorothiazide Zentiva kombineres med andre antihypertensiva (se pkt.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2875 på den anden side.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2876 på den anden side.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2775 på den anden side.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2776 på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg may be administered in patients insufficiently controlled by Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg. Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Danish: Zentiva 150 mg/12,5 mg.  Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide Zentiva 300 mg /12,5 mg.
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets.
Danish: LÆGEMIDLETS NAVN Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tabletter
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: Talk to your doctor before taking Irbesartan Hydrochlorothiazide Zentiva and if any of the following apply to you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Irbesartan Hydrochlorothiazide Zentiva, hvis du oplever følgende:
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide
Danish: Zentiva 150 mg/12,5 mg.  Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg kan gives til patienter, der er utilstrækkeligt regulerede med Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg.
English: Conversely, due to the irbesartan component of Irbesartan Hydrochlorothiazide Zentiva hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Danish: Det er især tilfældet ved nyrefunktionsnedsættelse og/eller hjertesygdom og diabetes mellitus.
English: • Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Danish: Når en direkte ændring fra monoterapi til de faste kombinationer påtænkes, bør følgende retningslinjer overvejes:  Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg kan gives til patienter, hvis blodtryk ikke kan reguleres tilstrækkeligt med hydrochlorthiazid eller irbesartan 150 mg alene;  Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg kan gives til patienter, der er utilstrækkeligt regulerede med irbesartan 300 mg eller med Irbesartan Hydrochlorothiazide
English: 120 (60 x 2) capsules (multipack)
Danish: 120 (60 x 2) kapsler (multipakning)
English: If this does occur, it is most likely to occur at the first dose.
Danish: Hvis dette sker, vil det med størst sandsynlighed ske ved den første dosis.
English: This can even be life threatening.
Danish: Dette kan endda være livstruende.
English: 4866 Unterach am Attersee Austria
Danish: 4866 Unterach am Attersee Østrig
English: In some cases you may need a blood transfusion.
Danish: I nogle tilfælde kan du få brug for en blodtransfusion.
English: This pattern of treatment will normally be repeated every three weeks.
Danish: Denne behandling gentages normalt hver 3. uge.
English: Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
Danish: Dato for første markedsføringstilladelse: 22. august 2007 Dato for seneste fornyelse: 16. juni 2017
English: These patients should be treated with caution.
Danish: Disse patienter skal behandles med forsigtighed.
English: Efficacy and safety were similar for both regimens.
Danish: Effekt og sikkerhed var den samme for begge doseringer.
English: • Signs of infection.
Danish: • Tegn på en infektion.
English: This includes spontaneous case reports as well as serious adverse events from ongoing studies.
Danish: Dette omfatter spontane bivirkningsindberetninger såvel som alvorlige hændelser fra igangværende studier.
English: Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.
Danish: På grund af små patientpopulationer i dette sygdomsstadie er oplysningerne til støtte for indikationerne baseret på begrænsede data.
English: The following additional adverse reactions were seen:
Danish: Følgende yderligere bivirkninger er observeret:
English: Family planning should be discussed with patients as appropriate.
Danish: Familieplanlægning bør diskuteres med patienterne efter behov.
English: There is no known reason for this.
Danish: Forklaringen på dette er ikke kendt.
English: 21 days.
Danish: 21 år.
English: Nelarabine should not be used during pregnancy unless clearly necessary.
Danish: Nelarabin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Atriance is used to treat patients with:
Danish: Atriance anvendes til behandling af patienter med:
English: This being an approval under exceptional circumstance and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige vilkår, og i henhold til artikel 14, stk. 8 i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: See the leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: Your doctor will decide how many treatment cycles are required.
Danish: Lægen vil beslutte, hvor mange behandlingsforløb der kræves.
English: The abnormal high number of white blood cells can appear in the blood and other parts of the body.
Danish: Det unormalt høje antal hvide blodceller kan forekomme i blodet og andre dele af kroppen.
English: (36 %) in paediatric patients] on day 1.
Danish: (36 %) i pædiatriske patienter] på dag 1.
English: A risk to the newborn/infant cannot be excluded.
Danish: Det kan ikke udelukkes, at der er risiko for påvirkning af nyfødte/spædbørn.
English: This results in cell death.
Danish: Dette resulterer i celledød.
English: Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment.
Danish: Mandlige patienter, som ønsker at blive fædre, skal spørge lægen til råds om familieplanlægning eller behandling.