FrancophonIA/ELRC3.0 huggingface dataset:
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Danish: I to epidemiologiske studier baseret på det danske Cancerregister er der observeret øget risiko for nonmelanom hudkræft (basalcellekarcinom og pladecellekarcinom) ved en stigende kumulativ dosis af hydrochlorthiazid.
English: Cytotoxic agents
Danish: Cytotoksiske midler
English: Non-melanoma skin cancer: based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed (see also sections 4.4 and 5.1).
Danish: Non-melanom hudkræft: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft (se også pkt.
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg.
Danish: Der skal udvises forsigtighed hos patienter med hjertesvigt og lidelser i kranspulsåren, især ved maksimumdosis af Dafiro HCT, 10 mg/320 mg/25 mg.
English: • swelling of the gums
Danish: • hævede gummer
English: Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimise the risk of skin cancer.
Danish: For at minimere risikoen for hudkræft bør patienterne rådes til at træffe forebyggende foranstaltninger som f.eks. at begrænse eksponeringen for sollys og UV-stråler og, ved eksponering, at sørge for tilstrækkelig beskyttelse.
English: Amlodipine is excreted in human milk.
Danish: Amlodipin udskilles i modermælk.
English: Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited.
Danish: Der skal udvises forsigtighed, inklusive hyppigere monitorering af blodtrykket hos ældre patienter især ved den maksimale dosis af Dafiro HCT, 10 mg/320 mg/25 mg, da der er begrænset tilgængelig data for denne patientpopulation.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Danish: Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter
English: * See section 4.4 Photosensitivity ** Mostly consistent with cholestasis
Danish: Lysfølsomhed ** Oftest som følge af kolestase
English: • altered bowel habits
Danish: • ændrede afføringsvaner
English: These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Danish: Disse doser hos rotter (200 og 600 mg/kg/dag) er cirka 6 og 18 gange højere end den maksimalt anbefalede humane dosis baseret på mg/m
English: Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Dafiro HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension.
Danish: I et kontrolleret studie af patienter med moderat til svær ukompliceret hypertension blev der set udtalt hypotension, inklusive ortostatisk hypotension hos 1,7 % af patienterne, som blev behandlet med den maksimale dosis af Dafiro HCT (10 mg/320 mg/25 mg) sammenlignet med 1,8 % af patienterne, som blev behandlet med valsartan/hydrochlorthiazid (320 mg/25 mg), 0,4 % af patienterne, som blev behandlet med amlodipin/valsartan (10 mg/320 mg) og 0,2 % af patienterne, som blev behandlet med hydrochlorthiazid/amlodipin (25 mg/10 mg).
English: This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Dafiro HCT is not recommended.
Danish: Dette er en sygdom, hvor dine binyrer producerer for meget af hormonet aldosteron.
English: Dual blockage of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Danish: Dobbelthæmning af RAAS ved kombination af ACE-hæmmere med ARBer eller aliskiren frarådes derfor (se pkt.
English: (It is also recommended to avoid Dafiro HCT in early pregnancy - see Pregnancy section.)
Danish: HCT tidligt i graviditeten - se afsnittet om Graviditet).
English: if you are allergic to amlodipine or to any other calcium channel blockers, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of this medicine (listed in section 6).
Danish: hydrochlorthiazid, sulfonamid-afledte stoffer (medicin, som bruges til at behandle infektioner i brystet eller urinvejene), eller et af de øvrige indholdsstoffer i Dafiro HCT (angivet i punkt 6).
English: • loss of pain sensation
Danish: • manglende smertefølelse
English: Dafiro HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Danish: Dafiro HCT er kontraindiceret hos patienter med svært nedsat nyrefunktion, patienter med anuri og patienter i dialyse (se pkt.
English: • medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);
Danish: • medicin til at lindre smerter eller mod betændelse, specielt non-steroid anti-inflammatorisk medicin (NSAID), inkl.
English: Do not take Dafiro HCT if you are more than 3 months pregnant.
Danish: Tag ikke Dafiro HCT - hvis du er mere end 3 måneder henne i graviditeten (det anbefales også at undgå brug af Dafiro
English: • visual disturbances
Danish: • synsforstyrrelser
English: Skin discoloration
Danish: Misfarvning af huden
English: Very rare (may affect up to 1 in 10,000 people):
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer)
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer)
English: • sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)
Danish: • nysen/snue pga. en betændelseslignende reaktion i næseslimhinden
English: Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Dafiro HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited.
Danish: Der skal udvises forsigtighed over for patienter med hjertesvigt og lidelser i kranspulsåren, især ved den maksimale dosis af Dafiro HCT, 10 mg/320 mg/25 mg, da der kun er begrænsede data tilgængelige fra disse patientgrupper.
English: • medicines for the treatment of gout, such as allopurinol;
Danish: • medicin til behandling af urinsyre-gigt, som fx allupurinol;
English: fever (erythema multiforme)
Danish: afskalning af hud, feber (erythema multiforme)
English: Aplastic anaemia
Danish: Aplastisk anæmi
English: • other medicines to treat high blood pressure, including methyldopa;
Danish: • anden medicin til behandling af forhøjet blodtryk inkl.
English: Hypoesthesia
Danish: Hypokaliæmi
English: Hypokalaemia
Danish: Hypomagnesiæmi
English: • iodine contrast media (agents used for imaging examinations);
Danish: • iodkontrastmidler (stoffer, som bruges til billeddiagnostik);
English: The use of Dafiro HCT during breastfeeding is not recommended.
Danish: Brug af Dafiro HCT frarådes under amning.
English: • skin discolouration
Danish: • misfarvninger af huden
English: Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC.
Danish: Hydrochlorthiazids fotosensibiliserende virkning kan være en mulig mekanisme i forhold til non-melanom hudkræft.
English: • medicines used for oesophageal ulceration and inflammation (carbenoxolone);
Danish: • medicin mod sår i spiserøret og spiserørskatar (carbenoxolon);
English: Due to the valsartan component, Dafiro HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Pga. indholdet af valsartan er Dafiro HCT kontraindiceret til patienter med stærkt nedsat leverfunktion (se pkt.
English: Valsartan Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Danish: Kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller anden medicin, som øger kaliumniveauet
English: Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Danish: Samtidig administration af thiaziddiuretika, herunder hydrochlorthiazid, kan øge risikoen for overfølsomhedsreaktioner over for allopurinol
English: if you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions).
Danish: - hvis du har et lavt indhold af natrium i blodet (med eller uden symptomer som fx træthed,
English: • discomfort or enlargement of the breasts in men
Danish: • udvikling af bryster hos mænd
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Danish: Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter
English: Extrapyramidal syndrome
Danish: Ekstrapyrimidalt syndrom -
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer)
English: • decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)
Danish: • nedsat antal blodplader, som kan medføre blå mærker og tendens til blødning
English: Grapefruit and grapefruit juice should not be consumed by people who are prescribed Dafiro HCT.
Danish: Brug af Dafiro HCT sammen med mad, drikke og alkohol Du må ikke indtage grapefrugt og grapefrugtjuice, mens du får ordineret Dafiro HCT.
English: Paraesthesia
Danish: Halsirritation
English: • yellowing of the skin (jaundice)
Danish: • hævede ankler (ødemer)
English: • mood changes
Danish: • vægtændring
English: • inflammation of blood vessels often with skin rash
Danish: • årebetændelse, oftest med hududslæt
English: • heart attack
Danish: • hjertetilfælde,
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer)
English: Pack sizes: 56, 98 or 280 film-coated tablets Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.
Danish: Multipakninger på 280 tabletter, bestående af 4 kartoner, der hver indeholder 70 tabletter.
English: How to take Dafiro HCT
Danish: Sådan skal du tage Dafiro HCT
English: • itchy skin
Danish: • gul hud
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Danish: Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter er gule, ovale tabletter præget med ”NVR” på den ene side og ”VEL” på den anden side.
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side.
Danish: Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter er brun-gule, ovale tabletter præget med ”NVR” på den ene side og ”VFL” på den anden side.
English: Agranulocytosis, bone marrow failure
Danish: Nedsat hæmoglobin og hæmatokrit
English: • indigestion
Danish: • halsirritation
English: Amantadine
Danish: Amantadin
English: In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Dafiro HCT.
Danish: Der kan opstå symptomatisk hypotension efter indledning af behandling med Dafiro HCT hos patienter med væske- og/eller natriummangel, som fx patienter, der får høje doser diuretika.
English: • sensitivity to light
Danish: • øget lysfølsomhed
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Danish: Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter er svagt gule, ovale tabletter præget med ”NVR” på den ene side og ”VDL” på den anden side.
English: What Dafiro HCT is and what it is used for What you need to know before you take Dafiro HCT How to take Dafiro HCT
Danish: Det skal du vide, før du begynder at tage Dafiro HCT Sådan skal du tage Dafiro HCT Bivirkninger
English: If you think you may be allergic, do not take Dafiro HCT and talk to your doctor.
Danish: Hvis du tror, du er overfølsom, skal du tale med din læge, inden du tager Dafiro HCT.
English: Dafiro 10 mg/320 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
Danish: Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter
English: • anxiety
Danish: • angst
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Danish: Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Danish: Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
Danish: Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter
English: • tiredness
Danish: • mavekatar
English: • disorder in passing urine
Danish: • ubehag i maven
English: Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Due to the valsartan component, Dafiro HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
Danish: På grund af indholdet af valsartan er Dafiro HCT kontraindiceret til patienter med nedsat leverfunktion (se pkt.
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Danish: Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter er brun-gule, ovale tabletter præget med ”NVR” på den ene side og ”VHL” på den anden side.
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon (type A); vandfri kolloid silica; magnesiumstearat; hypromellose (substitutionstype 2910 (3 mPa.s)); macrogol 4000; talcum; titandioxid (E 171).
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 320 mg valsartan og 25 mg hydrochlorthiazid.
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: • low level of potassium in the blood
Danish: • lavt indhold af kalium i blodet
English: EU/1/09/574/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/574/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: 280 filmovertrukne tabletter (mulitpakning, 4 kartoner af 70 tabletter) (enhedsdosis)
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Dafiro HCT Fortæl altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Dizziness
Danish: Sløvhed
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, yellow iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon (type A); vandfri kolloid silica; magnesiumstearat; hypromellose (substitutionstype 2910 (3 mPa.s)); macrogol 4000; talcum; gul jernoxid (E 172).
English: Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Danish: Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Danish: Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Danish: Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Danish: Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 25 mg hydrochlorthiazid.
English: Cardiac disorders Palpitations
Danish: ”obstruktiv hypertrofisk kardiomyopati”).
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon (type A); vandfri kolloid silica; magnesiumstearat; hypromellose (substitutionstype 2910 (3 mPa.s)); macrogol 4000; talcum; titandioxid (E 171); gul jernoxid (E 172); rød jernoxid (E 172).
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 5 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 25 mg hydrochlorthiazid.
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 12,5 mg hydrochlorthiazid.
English: if you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
Danish: opkastning, forstoppelse, mavesmerter, hyppig vandladning, tørst, muskelsvaghed og trækninger.
English: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 5 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 12,5 mg hydrochlorthiazid.
English: Blood urea nitrogen increased
Danish: Forhøjet urinsyre i blodet
English: What Dafiro HCT looks like and contents of the pack Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Danish: Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter er hvide, ovale tabletter præget med ”NVR” på den ene side og ”VCL” på den anden side.
English: Hepatic impairment, biliary cirrhosis or cholestasis.
Danish: 4.4 og 4.6) - Nedsat leverfunktion, biliær cirrhose eller kolestase.
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous, magnesium stearate, hypromellose (substitution type 2910 (3 mPa.s)), macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Danish: Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon (type A); vandfri kolloid silica; magnesiumstearat; hypromellose (substitutionstype 2910 (3 mPa.s)); macrogol 4000; talcum; titandioxid (E 171); gul jernoxid (E 172).
English: • fever (pyrexia)
Danish: cyster og polypper)
English: • dizziness
Danish: • hudkløe
English: Due to the hydrochlorothiazide component, Dafiro HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Danish: 4.3) og til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) <30 ml/min/1,73 m2) (se pkt.
English: If you take more Dafiro HCT than you should
Danish: Hvis du har taget for meget Dafiro HCT
English: • kidney disorders
Danish: • rygsmerter
English: Constipation
Danish: Døsighed
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som læge-midlet er beregnet til
English: EU (MA) number Invented name
Danish: EU/2/12/146/003 Semintra 10 mg/ml oral opløsning Katte
English: Target species
Danish: EU-nummer
English: The full EPAR and risk management plan summary for Pemetrexed Lilly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Pemetrexed Lilly findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Lilly.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Lilly.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Lægemidlet fås kun på recept og bør kun gives under overvågning af en læge, der er specialiseret i brug af kemoterapi.