natgillin/translations-raw huggingface dataset:
Den maksimale anbefalede dosis til patienter med let til moderat nedsat leverfunktion uden kolestase er 80 mg valsartan, og Dafiro HCT er derfor ikke egnet til denne patientgruppe (se pkt.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan and therefore Dafiro HCT is not suitable in this group of patients (see sections 4.3, 4.4 and 5.2).
Dafiro HCT bør kun bruges efter korrektion af eventuel eksisterende væske- eller natriummangel.
Dafiro HCT should be used only after correction of any pre-existing sodium and/or volume depletion.
4.1) med nedsat leverfunktion skiftes til Dafiro HCT, skal den laveste tilgængelige amlodipinkombination anvendes.
When switching eligible elderly hypertensive patients (see section 4.1) to Dafiro HCT, the lowest available dose of the amlodipine component should be used.
Hvis du holder op med at tage Dafiro HCT
If you stop taking Dafiro HCT
Hos silkeaber, som fik sammenlignelige doser, sås tilsvarende, men mere alvorlige ændringer, især i nyrerne, hvor der udvikledes nefropati, omfattende forhøjet carbamid g kreatinin.
In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine.
Hvis du har glemt at tage Dafiro HCT
If you forget to take Dafiro HCT
Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter.
Multipack: 280 (20 packs of 14) film-coated tablets.
Tilgængelige data fra epidemiologiske studier viser en kumulativ dosis-afhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft.
Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and NMSC has been observed.
- hvis du har urinsyregigt (urinsyrekrystaller i leddene).
if you have gout (uric acid crystals in the joints).
- Samtidig brug af Dafiro HCT og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m 2) (se pkt.
Concomitant use of Dafiro HCT with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Dafiro HCT indeholder:
What Dafiro HCT contains
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.
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.
Cytotoksiske midler
Cytotoxic agents
Non-melanom hudkræft: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft (se også pkt.
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).
Der skal udvises forsigtighed hos patienter med hjertesvigt og lidelser i kranspulsåren, især ved maksimumdosis af Dafiro HCT, 10 mg/320 mg/25 mg.
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.
• hævede gummer
• swelling of the gums
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.
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.
Amlodipin udskilles i modermælk.
Amlodipine is excreted in human milk.
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.
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.
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
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
Lysfølsomhed ** Oftest som følge af kolestase
* See section 4.4 Photosensitivity ** Mostly consistent with cholestasis
• ændrede afføringsvaner
• altered bowel habits
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
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).
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).
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.
Dette er en sygdom, hvor dine binyrer producerer for meget af hormonet aldosteron.
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.
Dobbelthæmning af RAAS ved kombination af ACE-hæmmere med ARBer eller aliskiren frarådes derfor (se pkt.
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).
HCT tidligt i graviditeten - se afsnittet om Graviditet).
(It is also recommended to avoid Dafiro HCT in early pregnancy - see Pregnancy section.)
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).
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).
• manglende smertefølelse
• loss of pain sensation
Dafiro HCT er kontraindiceret hos patienter med svært nedsat nyrefunktion, patienter med anuri og patienter i dialyse (se pkt.
Dafiro HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
• medicin til at lindre smerter eller mod betændelse, specielt non-steroid anti-inflammatorisk medicin (NSAID), inkl.
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors);
Tag ikke Dafiro HCT - hvis du er mere end 3 måneder henne i graviditeten (det anbefales også at undgå brug af Dafiro
Do not take Dafiro HCT if you are more than 3 months pregnant.
• synsforstyrrelser
• visual disturbances
Misfarvning af huden
Skin discoloration
Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer)
Very rare (may affect up to 1 in 10,000 people):
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
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
Sjælden (kan forekomme hos op til 1 ud af 1.000 personer)
Rare (may affect up to 1 in 1,000 people):
• nysen/snue pga. en betændelseslignende reaktion i næseslimhinden
• sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis)
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.
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.
• medicin til behandling af urinsyre-gigt, som fx allupurinol;
• medicines for the treatment of gout, such as allopurinol;
afskalning af hud, feber (erythema multiforme)
fever (erythema multiforme)
Aplastisk anæmi
Aplastic anaemia
• anden medicin til behandling af forhøjet blodtryk inkl.
• other medicines to treat high blood pressure, including methyldopa;
Hypokaliæmi
Hypoesthesia
Hypomagnesiæmi
Hypokalaemia
• iodkontrastmidler (stoffer, som bruges til billeddiagnostik);
• iodine contrast media (agents used for imaging examinations);
Brug af Dafiro HCT frarådes under amning.
The use of Dafiro HCT during breastfeeding is not recommended.
• misfarvninger af huden
• skin discolouration
Hydrochlorthiazids fotosensibiliserende virkning kan være en mulig mekanisme i forhold til non-melanom hudkræft.
Photosensitising actions of hydrochlorothiazide could act as a possible mechanism for NMSC.
• medicin mod sår i spiserøret og spiserørskatar (carbenoxolon);
• medicines used for oesophageal ulceration and inflammation (carbenoxolone);
Pga. indholdet af valsartan er Dafiro HCT kontraindiceret til patienter med stærkt nedsat leverfunktion (se pkt.
Due to the valsartan component, Dafiro HCT is contraindicated in patients with severe hepatic impairment (see section 4.3).
Kaliumbesparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller anden medicin, som øger kaliumniveauet
Valsartan Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Samtidig administration af thiaziddiuretika, herunder hydrochlorthiazid, kan øge risikoen for overfølsomhedsreaktioner over for allopurinol
Co-administration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
- hvis du har et lavt indhold af natrium i blodet (med eller uden symptomer som fx træthed,
if you have a low level of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions).
• udvikling af bryster hos mænd
• discomfort or enlargement of the breasts in men
Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets
Ekstrapyrimidalt syndrom -
Extrapyramidal syndrome
Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer)
Uncommon (may affect up to 1 in 100 people):
• nedsat antal blodplader, som kan medføre blå mærker og tendens til blødning
• decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage)
Brug af Dafiro HCT sammen med mad, drikke og alkohol Du må ikke indtage grapefrugt og grapefrugtjuice, mens du får ordineret Dafiro HCT.
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Dafiro HCT.
Halsirritation
Paraesthesia
• hævede ankler (ødemer)
• yellowing of the skin (jaundice)
• vægtændring
• mood changes
• årebetændelse, oftest med hududslæt
• inflammation of blood vessels often with skin rash
• hjertetilfælde,
• heart attack
Almindelig (kan forekomme hos op til 1 ud af 10 personer)
Common (may affect up to 1 in 10 people):
Multipakninger på 280 tabletter, bestående af 4 kartoner, der hver indeholder 70 tabletter.
Pack sizes: 56, 98 or 280 film-coated tablets Multipacks of 280 tablets, comprising 4 cartons, each containing 70 tablets.
Sådan skal du tage Dafiro HCT
How to take Dafiro HCT
• gul hud
• itchy skin
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.
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.
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.
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.
Nedsat hæmoglobin og hæmatokrit
Agranulocytosis, bone marrow failure
• halsirritation
• indigestion
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.
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.
• øget lysfølsomhed
• sensitivity to light
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.
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.
Det skal du vide, før du begynder at tage Dafiro HCT Sådan skal du tage Dafiro HCT Bivirkninger
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
Hvis du tror, du er overfølsom, skal du tale med din læge, inden du tager Dafiro HCT.
If you think you may be allergic, do not take Dafiro HCT and talk to your doctor.
Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
Dafiro 10 mg/320 mg/25 mg film-coated tablets The active substances of Dafiro HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets
• angst
• anxiety
Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets
Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets
Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets
• mavekatar
• tiredness
• ubehag i maven
• disorder in passing urine
Dafiro HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
På grund af indholdet af valsartan er Dafiro HCT kontraindiceret til patienter med nedsat leverfunktion (se pkt.
Due to the valsartan component, Dafiro HCT is contraindicated in patients with hepatic impairment (see sections 4.2 and 4.3).
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.
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.
Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon (type A); vandfri kolloid silica; magnesiumstearat; hypromellose (substitutionstype 2910 (3 mPa.s)); macrogol 4000; talcum; titandioxid (E 171).
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).
Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 320 mg valsartan og 25 mg hydrochlorthiazid.
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.
Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
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.
Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
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.
• lavt indhold af kalium i blodet
• low level of potassium in the blood
280 filmovertrukne tabletter (mulitpakning, 4 kartoner af 70 tabletter) (enhedsdosis)
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)
Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
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.
Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
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.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Sløvhed
Dizziness
Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon (type A); vandfri kolloid silica; magnesiumstearat; hypromellose (substitutionstype 2910 (3 mPa.s)); macrogol 4000; talcum; gul jernoxid (E 172).
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).
Dafiro HCT 10 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 5 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Dafiro HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 25 mg hydrochlorthiazid.
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
”obstruktiv hypertrofisk kardiomyopati”).
Cardiac disorders Palpitations
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).
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).
Hver filmovertrukket tablet indeholder 5 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 25 mg hydrochlorthiazid.
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
opkastning, forstoppelse, mavesmerter, hyppig vandladning, tørst, muskelsvaghed og trækninger.
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).
Hver filmovertrukket tablet indeholder 5 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 12,5 mg hydrochlorthiazid.
Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Forhøjet urinsyre i blodet
Blood urea nitrogen increased
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.
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.
4.4 og 4.6) - Nedsat leverfunktion, biliær cirrhose eller kolestase.
Hepatic impairment, biliary cirrhosis or cholestasis.
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).
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).
cyster og polypper)
• fever (pyrexia)
• hudkløe
• dizziness
4.3) og til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) <30 ml/min/1,73 m2) (se pkt.
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).
Hvis du har taget for meget Dafiro HCT
If you take more Dafiro HCT than you should
• rygsmerter
• kidney disorders
Døsighed
Constipation
Særnavn Styrke Lægemiddelform Dyrearter, som læge-midlet er beregnet til
Strength Pharmaceutical form
EU/2/12/146/003 Semintra 10 mg/ml oral opløsning Katte
EU (MA) number Invented name
EU-nummer
Target species
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.
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.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pemetrexed Lilly.
This is a summary of the European public assessment report (EPAR) for Pemetrexed Lilly.