natgillin/translations-raw huggingface dataset:
Ved en dosis på 20 mg én gang dagligt fik den potente CYP2D6-hæmmer, paroxetin, steady state-plasmakoncentrationen af ranolazin 1.000 mg administreret to gange dagligt til gennemsnitligt at stige 1,2 gange.
The potent CYP2D6 inhibitor paroxetine, at a dose of 20 mg once daily, increased steady-state plasma concentrations of ranolazine 1000 mg twice daily by an average of 1.2-fold.
Åndedrætsbesvær, hoste, næseblødning
Difficulty breathing, cough, nose bleed
Leipziger Straβe 7-13 01097 Dresden Tyskland eller
01097 Dresden Germany or
750 mg tablet: glyceroltriacetat, lactosemonohydrat, Blå 1/Brilliant Blue FCF aluminium lake (E 133) og Gul 5/Tartrazin aluminium lake (E 102)
750 mg tablet: glycerol triacetate, lactose monohydrate, Blue #1/Brilliant Blue FCF Aluminium Lake
1.000 ng/ml, hvilket ca. svarer til en stigning på 2 til 7 millisekunder i plasmakoncentrationsområdet for ranolazin 500 til 1.000 mg administreret to gange dagligt.
which is approximately equal to a 2- to 7-msec increase over the plasma concentration range for ranolazine 500 to 1000 mg twice daily.
Øvrige hjælpestoffer i 375 mg-tabletter: MakrogolPolysorbat 80
Additional excipients for 375 mg tablet: Macrogol
Sådan skal du tage Ranexa
How to take Ranexa
Ikke almindelig: hedetur, hypotension.
Uncommon: hot flush, hypotension.
Ranexa er kontraindiceret hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
Ranexa is contraindicated in patients with moderate or severe hepatic impairment (see sections 4.3 and 5.2).
Ranexa kan have bivirkninger såsom svimmelhed (almindeligt), uklart syn (ikke almindeligt),
Ranexa may cause side effects such as dizziness (common), blurred vision (uncommon), confusional state (uncommon), hallucination (uncommon), double vision (uncommon), coordination problems
Transitorisk iskæmisk anfald forekom oftere hos patienter, der blev behandlet med 1000 mg ranolazin to gange dagligt sammenlignet med placebo (hhv. 1,0 % vs. 0,2 %).
Also, transient ischemic attack occurred more frequently in patients treated with ranolazine 1000 mg twice daily compared with placebo (1.0% vs 0.2%, respectively); however, the incidence of stroke was similar between treatment groups (ranolazine 1.7% vs placebo 1.5%).
I en populationsanalyse af kombinerede data fra 1.308 patienter og raske frivillige forsøgspersoner påvistes en gennemsnitlig stigning i QTc fra baseline på 2,4 msek.
A population analysis of combined data from 1,308 patients and healthy volunteers demonstrated a mean increase in QTc from baseline of 2.4 msec per 1000 ng/ml ranolazine plasma concentration.
Angst, søvnbesvær, forvirring, hallucinationer
Anxiety, difficulty sleeping, confusional state, hallucination Blurred vision, visual disturbance
Ranexa 750 mg depottabletter indeholder azofarvestoffet E 102.
Ranexa 750 mg prolonged-release tablets contain the azo colouring agent E102.
Kontakt din læge, før du tager dette lægemiddel, hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ikke almindelig: mavesmerter, tør mund, dyspepsi, flatulens, mavekneb.
Uncommon: abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort.
INFORMATION I BRAILLE-SKRIFT Ranexa 375 mg
INFORMATION IN BRAILLE Ranexa 375 mg
Bivirkningsincidensen var højere hos ældre patienter (se pkt.
The incidence of adverse events was higher in the elderly (see section 4.8).
Depottablet Lys orange, oval tablet præget med 500 på den ene side.
Light orange oval-shaped tablet engraved with 500 on one side.
Sjældne bivirkninger (forekommer hos 1 til 10 brugere ud af 10.000) er: Vandladningsbesvær
Rare side effects (occur in 1 to 10 users in 10,000) are:
Behandling med Ranexa bør ikke initieres ved samtidig administration af CYP3A4-induktorer, f.eks. rifampicin, phenytoin, phenobarbital, carbamazepin og prikbladet perikon (se pkt.
Initiation of treatment with Ranexa should be avoided during administration of inducers of CYP3A4 (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort) (see section 4.4).
Hos patienter, der får Ranexa, bør det overvejes at begrænse atorvastatindosis og iværksætte passende klinisk monitorering.
Dose limitation of atorvastatin and appropriate clinical monitoring may be considered when taking Ranexa.
Ikke almindelige bivirkninger (forekommer hos 1 til 10 brugere ud af 1.000) er: Føleforstyrrelser
Uncommon side effects (occur in 1 to 10 users in 1,000) are:
Der blev ikke konstateret nogen virkning på binyrebarkaksen for menneskers vedkommende.
No effect on the adreno-cortical axis was noted in humans.
Norge Menarini International Operations Luxembourg S.A.
MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A.
INFORMATION I BRAILLE-SKRIFT Ranexa 750 mg
INFORMATION IN BRAILLE Ranexa 750 mg
Ikke almindelig: udmattelse, perifere ødemer.
Uncommon: fatigue, peripheral oedema.
Depottablet Lyseblå, oval tablet præget med 375 på den ene side.
Pale blue oval-shaped tablet engraved with 375 on one side.
• Patienter med lav kropsvægt, dvs. ≤ 60 kg (se pkt.
• Patients with low weight (≤ 60 kg) (see sections 4.2, 4.8, and 5.2).
Indehaveren af markedsføringstilladelsen Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Marketing Authorisation Holder Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Ændringer i føle- eller smagssansen, rystelser, træthed, følelse af ugidelighed, søvnighed eller døsighed, besvimelsesfornemmelse eller besvimelse, svimmelhed, når man rejser sig op Mørk urin, blod i urinen, vandladningsbesvær
Changes in sensation (touch or taste), tremor, feeling tired or sluggish, sleepiness or drowsiness,
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
MARKETING AUTHORISATION HOLDER Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release
Samtidig administration af potente CYP3A4-hæmmere, f.eks. itraconazol, ketoconazol, voriconazol, posaconazol, hiv-proteasehæmmere, clarithromycin, telithromycin og nefazodon (se pkt.
Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) (see sections 4.2 and 4.5).
Nældefeber, overfølsomhedsreaktion i huden Impotens
Hives, allergic skin reaction
Samtidig administration af ranolazin og potente CYP3A4-hæmmere, f.eks. itraconazol, ketoconazol, voriconazol, posaconazol, hiv-proteasehæmmere, clarithromycin, telithromycin og nefazodon, er kontraindiceret (se pkt.
Combining ranolazine with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone) is contraindicated (see section 4.3).
Kraftløshed og svaghed
Feeling weak
Sjælden: sammensnøring af strube.
Rare: throat tightness.
INFORMATION I BRAILLE-SKRIFT Ranexa 500 mg
INFORMATION IN BRAILLE Ranexa 500 mg
Svimmelhed
Dizziness
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 30 depottabletter
PHARMACEUTICAL FORM AND CONTENTS 30 prolonged-release tablets 60 prolonged-release tablets 100 prolonged-release tablets
Nedsat leverfunktion: Forsigtig dosistitrering anbefales hos patienter med let nedsat leverfunktion (se pkt.
Hepatic impairment: Careful dose titration is recommended in patients with mild hepatic impairment (see sections 4.4 and 5.2).
Depottablet Lysegrøn, oval tablet præget med 750 på den ene side.
Pale green oval-shaped tablet engraved with 750 on one side.
Ranexa kan medføre svimmelhed, sløret syn, diplopi, konfusion, koordinationsforstyrrelser og hallucinationer (se pkt.
Ranexa may cause dizziness, blurred vision, diplopia, confusional state, coordination abnormal, hallucination (see section 4.8), which may affect the ability to drive and use machines.
Kronisk hjerteinsufficiens: Patienter med kronisk hjerteinsufficiens (NYHA-klasse III og IV) vurderedes at have en 1,3 gange højere plasmakoncentration.
CHF: CHF NYHA Class III and IV were estimated to have about 1.3-fold higher plasma concentrations.
Amning Du bør ikke tage Ranexa, hvis du ammer.
You should not take Ranexa if you are breast-feeding.
• Samtidig administration af P-glykoproteinhæmmere (se pkt.
• Concomitant administration of P-gp inhibitors (see sections 4.2 and 4.5).
S.R.L.
S.A.
EU/1/08/462/001 60 tabletter i blisterpakning EU/1/08/462/002 60 tabletter i flaske EU/1/08/462/007 30 tabletter i blisterpakning EU/1/08/462/008 100 tabletter i blisterpakning
EU/1/08/462/001 60 tablets in blister pack EU/1/08/462/002 60 tablets in bottle EU/1/08/462/007 30 tablets in blister pack EU/1/08/462/008 100 tablets in blister pack
EU/1/08/462/003 60 tabletter i blisterpakning EU/1/08/462/004 60 tabletter i flaske EU/1/08/462/009 30 tabletter i blisterpakning EU/1/08/462/010 100 tabletter i blisterpakning
EU/1/08/462/003 60 tablets in blister pack EU/1/08/462/004 60 tablets in bottle EU/1/08/462/009 30 tablets in blister pack EU/1/08/462/010 100 tablets in blister pack
Elektrokardiografisk virkning: Der er observeret dosis- og plasmakoncentrationsrelaterede stigninger i QTc-intervallet (ca. 6 msek.
Electrocardiographic effects: Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched
EU/1/08/462/005 60 tabletter i blisterpakning EU/1/08/462/006 60 tabletter i flaske EU/1/08/462/011 30 tabletter i blisterpakning EU/1/08/462/012 100 tabletter i blisterpakning
EU/1/08/462/005 60 tablets in blister pack EU/1/08/462/006 60 tablets in bottle EU/1/08/462/011 30 tablets in blister pack EU/1/08/462/012 100 tablets in blister pack
Jernoxid, rød (E172)
Polyvinyl alcohol-part hydrolyzed Iron oxide yellow (E172) Iron oxide red (E172) Talc
5.1), hvor patienter med ufuldstændig revaskularisering efter PCI fik op til 1000 mg ranolazin to gange dagligt eller placebo i ca. 70 uger.
An increased incidence of adverse events was seen among ranolazine treated patients in the RIVERPCI trial (see section 5.1) where patients with incomplete revascularization post-PCI were given ranolazine up to 1000 mg twice daily or placebo for approximately 70 weeks.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 375 mg ranolazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 375 mg ranolazine.
Ranexa 1.000 mg to gange dagligt fik plasmakoncentrationen af simvastatinlacton og simvastatinsyre til at stige med cirka en faktor 2.
Ranexa 1000 mg twice daily increased plasma concentrations of simvastatin lactone, simvastatin acid by about 2 fold.
LÆGEMIDLETS NAVN Ranexa 500 mg depottabletter Ranolazin
NAME OF THE MEDICINAL PRODUCT Ranexa 500 mg prolonged-release tablets Ranolazine
Dosering Ranexa fås som depottabletter med 375 mg, 500 mg og 750 mg.
Posology Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release tablets.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 500 mg ranolazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 500 mg ranolazine.
CYP2D6-hæmmere: Ranolazin metaboliseres delvist af CYP2D6.
CYP2D6 inhibitors: Ranolazine is partially metabolised by CYP2D6; therefore, inhibitors of this enzyme may increase plasma concentrations of ranolazine.
Moderat eller svært nedsat leverfunktion (se pkt.
Moderate or severe hepatic impairment (see sections 4.2 and 5.2).
LÆGEMIDLETS NAVN Ranexa 375 mg depottabletter Ranolazin
NAME OF THE MEDICINAL PRODUCT Ranexa 375 mg prolonged-release tablets Ranolazine
Talcum
EXP
Hvis noget af det ovenstående gælder for dig, er det muligt, at din læge nedsætter din dosis eller ændrer din behandling på anden vis.
Your doctor may decide to give you a lower dose or take other precautions if any of these apply to you.
Kvalme og opkastning
Warning and precautions
Nyrer og urinveje
Throat tightness
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver depottablet indeholder 750 mg ranolazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 750 mg ranolazine.
LÆGEMIDLETS NAVN Ranexa 750 mg depottabletter Ranolazin
NAME OF THE MEDICINAL PRODUCT Ranexa 750 mg prolonged-release tablets Ranolazine
ved 1.000 mg to gange dagligt), reduktion af T-takkens amplitude og i nogle tilfælde difasiske T-takker hos patienter i behandling med Ranexa.
Electrocardiographic effects: Dose and plasma concentration-related increases in the QTc interval (about 6 msec at 1000 mg twice daily), reductions in T wave amplitude, and in some cases notched T waves, have been observed in patients treated with Ranexa.
Dosistitrering hos patienter med lav kropsvægt skal gennemføres med forsigtighed (se pkt.
Dose titration in patients with low weight should be exercised with caution (see sections 4.4, 4.8, and 5.2).
forvirring (ikke almindeligt), hallucinationer (ikke almindeligt), dobbeltsyn (ikke almindeligt) eller koordinationsforstyrrelser (sjældent), som kan påvirke din evne til at køre eller betjene maskiner.
Ranexa may cause dizziness, blurred vision, diplopia, confusional state, coordination abnormal, and hallucination (see section 4.8), which may affect the ability to drive and use machines.
Muskelkramper
Muscle cramp
Svært nedsat nyrefunktion defineret som kreatininclearance på < 30 ml/min (se pkt.
Severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.2 and 5.2).
Ikke almindelig: dysuri, hæmaturi, kromaturi.
Renal and urinary disorders Uncommon: dysuria, haematuria, chromaturia.
Ikke almindelig: pruritus, hyperhidrosis.
Skin and subcutaneous tissue disorders Uncommon: pruritus, hyperhydrosis.
Der blev dog indberettet flere tilfælde af alvorlige kardiovaskulære hændelser (MACE) for patienter ≥ 75 år, der blev behandlet med ranolazin sammenlignet med placebo (hhv. 17,0 % vs. 11,3 %).
The risk of all cause mortality, CV death or major adverse cardiovascular events (MACE) and heart failure hospitalisation was similar between treatment groups in the overall population; however, MACE were reported more frequently in patients ≥ 75 years treated with ranolazine compared with placebo (17.0% vs 11.3%, respectively); in addition there was a numerical increase in all cause mortality in patients ≥ 75 years (9.2% vs. 5.1%, p = 0.074).
Hos patienter, der får Ranexa, bør det overvejes at begrænse dosis af andre statiner, der metaboliseres af CYP3A4 (f.eks. lovastatin).
Dose limitation of other statins, metabolised by CYP3A4 (e.g. lovastatin), may be considered when taking Ranexa.
- Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
Check with your doctor or pharmacist if you are not sure.
Hver tablet indeholder 375 mg ranolazin.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 375 mg of ranolazine.
Hver tablet indeholder 750 mg ranolazin.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 750 mg of ranolazine.
Hver tablet indeholder 500 mg ranolazin.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of ranolazine.
Uklart syn, synsforstyrrelser
Feeling sick, vomiting
Hvis du vil have yderligere oplysninger om Ranexa, skal du henvende dig til den lokale repræsentant: België/Belgique/Belgien Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
België/Belgique/Belgien Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
Brug af anden medicin sammen med Ranexa Brug ikke følgende medicin, hvis du tager Ranexa: - visse former for medicin, der bruges til behandling af bakterielle infektioner (clarithromycin, telithromycin), svampeinfektioner (itraconazol, ketoconazol, voriconazol, posaconazol), hivinfektion (proteasehæmmere), depression (nefazodon) eller forstyrrelser i hjerterytmen (f.eks. quinidin, dofetilid eller sotalol).
Do not use the following medicines if you take Ranexa: - certain medicines to treat bacterial infections (clarithromycin, telithromycin), fungal infections
Dato for første markedsføringstilladelse: 4. november 2009 Dato for seneste fornyelse: 4. juli 2014
Date of first authorisation: 04 November 2009 Date of latest renewal: 04 July 2014
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelig data)
Not known (frequency cannot be estimated from the available data):
Andre bivirkninger kan være:
Other side effects may include:
Nogle bivirkninger kan være alvorlige og kræver omgående lægebehandling.
Some side effects can be serious and need immediate medical attention.
Forsigtighed skal udvises ved brug af:
Caution should be used with:
Kravene for fremsendelsen af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Følg nøje lægens anvisning vedrørende startdosis nøje.
Follow your doctor's instructions for the starting dose carefully.
Hvis du oplever disse symptomer, må du ikke køre bil eller betjene maskiner.
If you experience these symptoms, do not drive or use tools or machines.
Fordelingsvolumen er omkring 21 l/kg.
Volume of distribution is approximately 21 l/kg.
Som for enhver kombination, der indeholder tre aktive stoffer, kan bivirkninger forbundet med hver enkelt komponent ikke udelukkes.
As for any combination containing three active substances, side effects associated with each individual component cannot be excluded.
Kontakt omgående din læge, hvis du får hvilken som helst af følgende alvorlige bivirkninger efter du har taget dette lægemiddel:
Consult a doctor immediately if you experience any of the following serious side effects after taking this medicine:
- hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Steadystate-plasmaniveauerne opnås efter vedvarende administration i 7-8 dage.
Steady-state plasma levels are reached after continuous administration for 7-8 days.
Valsartan omdannes ikke i stor grad, da kun omkring 20 % af dosis genfindes som metabolitter.
Valsartan is not transformed to a high extent as only about 20% of dose is recovered as metabolites.
• verapamil, diltiazem (hjertemedicin);
• verapamil, diltiazem (heart medicines);
Pædiatriske patienter (under 18 år) Der er ingen farmakokinetiske data tilgængelige for den pædiatriske population.
Paediatric patients (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Biotransformation Amlodipin bliver i udstrakt grad (ca. 90 %) metaboliseret i leveren til inaktive metabolitter.
Biotransformation Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
• D-vitamin og calciumsalte.
• vitamin D and calcium salts.
- Shock, herunder kardiogent shock.
Shock (including cardiogenic shock).
Forsigtighed skal iagttages ved langtidsbehandling med disse lægemidler.
Caution is indicated in long-term administration of these medicinal products.
• Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Antikolinerge midler og andre lægemidler, som påvirker den gastrointestinale motilitet
Anticholinergic agents and other medicinal products affecting gastric motility
Dafiro HCT anbefales derfor ikke til denne population.
Therefore, Dafiro HCT is not recommended in this population.
Denne medicin kan få dig til at føle svimmelhed, døsighed, kvalme eller få hovedpine.
This medicine may make you feel dizzy, drowsy, nauseous or have a headache.
Distributionsvolumenet er 4-8 l/kg.
The apparent volume of distribution is 4-8 l/kg.
Valsartan udskilles primært i fæces (omkring 83 % af dosis) og i urin (omkring 13 % af dosis) hovedsageligt som uomdannet stof.
Valsartan is primarily eliminated in faeces (about 83% of dose) and urine (about 13% of dose), mainly as unchanged drug.
Derfor anbefales tæt monitorering af lithiumkoncentrationen i serum ved samtidig brug.
Therefore careful monitoring of serum lithium concentrations is recommended during concomitant use.
- Svær hypotension.
Severe hypotension.
Børn og unge Brug af Dafiro HCT til børn og unge under 18 år frarådes.
Children and adolescents The use of Dafiro HCT in children and adolescents under 18 years of age is not recommended.
Du bør aldrig tage Dafiro HCT igen.
You should never take Dafiro HCT again.
• øget behov for vandladning om natten
• increased need to urinate at night
Det er imidlertid vigtigt at tage i betragtning, at Dafiro HCT kan øge den hypotensive virkning af andre antihypertensive stoffer.
However, it is important to take into account that Dafiro HCT may increase the hypotensive effect of other antihypertensive agents.
- hvis du har haft et hjerteanfald.
if you have experienced a heart attack.
Dafiro HCT frarådes i den tidlige periode af graviditeten og må ikke tages, når du er mere end 3 måneder henne i graviditeten, fordi det kan forårsage alvorlig skade på dit barn, hvis det tages efter tredje graviditetsmåned.
Dafiro HCT is not recommended in early pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Eftersom de tre aktive stoffer er lige veltolererede hos yngre og ældre patienter anbefales de normale doseringer (se pkt.
Since the three components are equally well tolerated in younger and elderly patients, normal dose regimens are recommended (see section 4.2).
En øget dosis af probenecid eller sulfinpyrazon kan være nødvendig.
Increase of dose of probenecid or sulfinpyrazone may be necessary.
Dafiro HCT er blevet undersøgt i et dobbeltblindet, aktivt-kontrolleret studie hos hypertensive patienter.
Dafiro HCT was studied in a double-blind, active controlled study in hypertensive patients.
Tag ikke Dafiro HCT sammen med grapefrugt eller grapefrugtjuice.
Do not take Dafiro HCT with grapefruit or grapefruit juice.
Stigningen i middelAUC er lineær og proportional med dosis i det terapeutiske område.
The increase in mean AUC is linear and dose proportional in the therapeutic range.
• glyceryltrinitrat (nitroglycerin) og andre nitrater eller andre stoffer, som kaldes ”vasodilatorer”
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
Doseringen af Dafiro HCT skal baseres på doserne af de individuelle komponenter i kombinationen ved tidspunktet for omskiftningen.
The dose of Dafiro HCT should be based on the doses of the individual components of the combination at the time of switching.
Inden skift til Dafiro HCT skal patienter være kontrolleret på stabile doser af monokomponenterne taget på samme tid.
Before switching to Dafiro HCT patients should be controlled on stable doses of the monocomponents taken at the same time.
Kutane lupus erythematosuslignende reaktioner, reaktivering af kutan lupus erythematosus
Cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus
Det er ikke relevant at anvende Dafiro HCT hos den pædiatriske population (patienter under 18 år) til indikationen essentiel hypertension.
There is no relevant use of Dafiro HCT in the paediatric population (patients below age 18 years) for the indication of essential hypertension.
Patienter med let til moderat nedsat nyrefunktion kan derfor få normal startdosis (se pkt 4.2 og 4.4).
Patients with mild to moderate renal impairment may therefore receive the usual initial dose (see sections 4.2 and 4.4).