natgillin/translations-raw huggingface dataset:
Indlægsseddel: Information til brugeren Leflunomide ratiopharm 20 mg filmovertrukne tabletter leflunomid
Package leaflet: Information for the user Leflunomide ratiopharm 20 mg film-coated tablets
hypourikæmi
hypouricemia
Alanin-aminotransferase (ALAT) eller serum-glutamopyruvattransferase (SGPT) og det fulde blodbillede inklusive leukocytdifferentialtælling og trombocyttal skal kontrolleres samtidigt med og med samme hyppighed:
Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: before initiation of leflunomide, every two weeks during the first six months of treatment, and every 8 weeks thereafter (see section 4.4).
For at få mere information om dette, skal du læse pkt.
For more information on these, please read section 4 (Possible side effects).
Hver tablet indeholder 10 mg leflunomid.
Each tablet contains 10 mg of leflunomide.
• blodprøver kan vise en forhøjelse af nogle leverresultater som kan føre til alvorlige tilstande såsom leverbetændelse og gulsot, alvorlige infektioner (blodforgiftning), som kan være livstruende,
(pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Da eventuelle leverskader forvoldt af alkohol kan forværres af behandling med Leflunomide ratiopharm, anbefales det ikke at drikke alkohol under behandling med Leflunomide ratiopharm.
It is not recommended to drink alcohol during treatment with Leflunomide ratiopharm.
Leflunomide ratiopharm 10 mg tabletter leflunomid
Leflunomide ratiopharm 10 mg tablets Leflunomide
Leflunomide ratiopharm 20 mg tabletter leflunomid
Leflunomide ratiopharm 20 mg tablets Leflunomide
Psykiske forstyrrelser Ikke almindelig: angst
Psychiatric disorders Uncommon:
Ikke almindelig: anæmi, let trombocytopeni (trombocytter < 100 G/l) Sjælden:
anaemia, mild thrombocytopenia (platelets <100 G/L)
• hvis du nogensinde har haft en allergisk reaktion over for leflunomide (specielt en alvorlig hudreaktion, ofte ledsaget af feber, ledsmerter, røde pletter på huden eller blærer, f.eks. Stevens-Johnson syndrom), over for jordnødder eller soja eller et af de øvrige indholdsstoffer i Leflunomide ratiopharm (angivet i pkt.
What you need to know before you take Leflunomide ratiopharm Do not take Leflunomide ratiopharm if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome), to peanut or soya or to any of the other ingredients of this medicine (listed in section if you have any liver problems, if you have moderate to severe kidney problems, if you have severely low numbers of proteins in your blood (hypoproteinaemia), if you suffer from any problem which affects your immune system (e.g. AIDS), if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, if you are suffering from a serious infection, if you are pregnant, think you may be pregnant, or are breast-feeding.
Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 10 ud af 100 personer)
Uncommon side effects (may affect up to 1 in 100 people)
Ikke kendt pulmonal hypertension
pulmonary hypertension Gastrointestinal disorders Common:
Hver filmovertrukken tablet indeholder 10 mg leflunomid.
Each film-coated tablet contains 10 mg of leflunomide.
• En filmovertrukken tablet indeholder 20 mg leflunomid.
One film-coated tablet contains 20 mg of leflunomide.
Leflunomide ratiopharm 10 mg filmovertrukne tabletter leflunomid
Leflunomide ratiopharm 10 mg film-coated tablets Leflunomide
Leflunomide ratiopharm 20 mg filmovertrukne tabletter leflunomid
Leflunomide ratiopharm 20 mg film-coated tablets Leflunomide
• 1 tablet på 20 mg Leflunomide ratiopharm daglig til behandling af gigt i forbindelse med psoriasis.
• For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.
Leflunomide ratiopharm 10 mg filmovertrukken tablet
Leflunomide ratiopharm 10 mg film-coated tablets
Leflunomide ratiopharm indeholder sojalecithin.
Leflunomide ratiopharm contains soya lecithin
Natriumlaurylsulfat
Sodium laurylsulfate Magnesium stearate
Leflunomide ratiopharm 20 mg filmovertrukken tablet
Leflunomide ratiopharm 20 mg film-coated tablets
Hvis du har taget for meget Leflunomide ratiopharm
If you take more Leflunomide ratiopharm than you should
• fald i antallet af røde blodlegemer (anæmi) og fald i antallet af blodplader (trombocytopeni),
a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
• teriflunomid mod dissemineret sklerose
• Physician Leaflet
• hovedpine, svimmelhed,
Hepatic impairment
Indhold Pakningsstørrelser
Packaging Content Package size
EU Nummer Produktnavn
EU Number
Fiskeolie 0,5 ml/ml
Fish Oil 0.5ml/Ml
Fiskeolie 1.000-mgkapsel
Fish Oil 1000mg Capsule
Omega-3syreethylestere 90 med en specifik sammensætning af EPA og DHA ikke lavere end 85 % 500-mg-kapsel
Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%.
1.000-mg-kapsel
1000mg Capsule
Ratiopharm Gmbh Omega-3 Ratiopharm Omega-3syreethylestere 90
Ratiopharm Gmbh Omega-3 Ratiopharm Omega-3-Acid Ethyl Esters 90 1000mg
Omega-3-fedtsyrer 1.000-mg-kapsel
Omega-3 Fatty Acids 1000mg Capsule
Ácidos Omega 3 Aristo Omega-3syreethylestere 1.000mg-kapsel
Ácidos Omega 3 Aristo Omega-3-Acid Ethyl Esters 1000mg Capsule
1 000-mg-tablet
1000mg
Triglycerider med middel kædelængde 1qs-kapsel, sojalecithin 1-qs-kapsel, Omega-3syreethylestere 90
Triglycerides Medium Chain 1qs Capsule, Lecithin Soya 1qs Capsule, Omega-3-Acid Ethyl Esters 90 1000mg Capsule
Docosahexaensyre 60mg-kapsel, eicosapentaensyre 90mg-kapsel
Docosahexaenoic Acid 60mg Capsule, Eicosapentaenoic Acid 90mg Capsule
Estere af umættede fedtsyrer 500-mgkapsel
Esters Of Unsaturated Fatty Acids 500mg Capsule
Docosahexaensyre 265mg/5 ml, eicosapentaensyre 390mg/5 ml
Docosahexaenoic Acid 265mg/5ml, Eicosapentaenoic Acid 390mg/5ml
Estere af umættede fedtsyrer 1.000-mgkapsel
Esters Of Unsaturated Fatty Acids 1000mg Capsule
Docosahexaensyre 120mg-kapsel, eicosapentaensyre 180mg-kapsel
Docosahexaenoic Acid 120mg Capsule, Eicosapentaenoic Acid 180mg Capsule
Docosahexaensyre 115mg-kapsel, eicosapentaensyre 170mg-kapsel
Docosahexaenoic Acid 115mg Capsule, Eicosapentaenoic Acid 170mg Capsule
Eicosapentaensyreethyl ester 430-mg-kapsel, docosahexaensyreethyle ster 437-mg-kapsel
Docosahexaenoic Acid Ethyl Ester 437mg Capsule
Ácidos Omega 3 Tarbis Docosahexaensyre 380mg-kapsel, eicosapentaensyre 460mg-kapsel, omega-3syreethylestere 90
Ácidos Omega 3 Tarbis Docosahexaenoic Acid 380mg Capsule,
Docosahexaensyre 115mg-kapsel, eicosapentaensyre/doco sahexaensyre 170-mgkapsel
Docosahexaenoic Acid 115mg Capsule, Eicosapentanoic Acid/Docosahexaenoic Acid 170mg Capsule
Docosahexaensyre 527 mg/5 ml, eicosapentaensyre/doco sahexaensyre 791 mg/5 ml
Docosahexaenoic Acid 527mg/5ml, Eicosapentanoic Acid/Docosahexaenoic Acid 791mg/5ml
Acidos Omega 3 Stada Omega-3syreethylestere 90
Acidos Omega 3 Stada Omega-3-Acid Ethyl Esters 90 1000mg
Docosahexaensyre 527 mg/5 ml, eicosapentaensyre 791 mg/5 ml
Docosahexaenoic Acid 527mg/5ml, Eicosapentaenoic Acid 791mg/5ml
Docosahexaensyre 115mg-kapsel, D-vitamin 1 IE/g, eicosapentaensyre 170-mg-kapsel, Avitamin 1 IE/g
Docosahexaenoic Acid 115mg Capsule, Vitamin D 1 I.U.G,
Eicosapentaensyreethyl ester 460-mg-kapsel, docosahexaensyreethyle ster 380-mg-kapsel
Docosahexaenoic Acid Ethyl Ester 380mg Capsule
Eicosapentaensyre 115mg-kapsel, D-vitamin 10 IE/g, docosahexaensyre 170mgkapsel, A-vitamin 100 IE/g
Eicosapentaenoic Acid 170mg Capsule, Vitamin A 100 I.U.G
Docosahexaensyre 527 mg/5 ml, D-vitamin 10 IE/g, eicosapentaensyre 791 mg/5 ml, A-vitamin 100 IE/g
Eicosapentaenoic Acid 791mg/5ml, Vitamin A 100 I.U.G
Docosahexaensyre 115 mgg, eicosapentaensyre 170 μgg
Docosahexaenoic Acid 115mgg,
Lægemiddelform Administration
Pharmaceutical Form Route of administration
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pioglitazone Actavis den 15. marts 2012.
The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.
Den fuldstændige EPAR for Pioglitazone Actavis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Pioglitazone Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Pioglitazone Actavis anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
Pioglitazone Actavis is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Det aktive stof i Pioglitazone Actavis, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner.
The active substance in Pioglitazone Actavis, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Behandlingen med Pioglitazone Actavis skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke får tilstrækkelig gavn af behandlingen.
Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pioglitazone Actavis.
This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis.
Det betyder, at Pioglitazone Actavis er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
This means that Pioglitazone Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Udvalget anbefalede, at Pioglitazone Actavis godkendes til anvendelse i EU.
The Committee recommended that Pioglitazone Actavis be approved for use in the EU.
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pioglitazone Actavis er af sammenlignelig kvalitet og er bioækvivalent med Actos.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos.
Hvis du ønsker yderligere oplysninger om behandling med Pioglitazone Actavis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Pioglitazone Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Pioglitazone Actavis er et "generisk lægemiddel".
Pioglitazone Actavis is a ‘generic medicine'.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pioglitazone Actavis?
What measures are being taken to ensure the safe and effective use of Pioglitazone Actavis?
Materialet skal redegøre for den mulige risiko for hjertesvigt og blærekræft ved lægemidler, der indeholder pioglitazon, kriterier for udvælgelse af patienterne og behovet for regelmæssig gennemgang og indstilling af behandlingen, hvis patienten ikke længere har gavn af den.
The company that markets Pioglitazone Actavis will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Andre oplysninger om Pioglitazone Actavis
Other information about Pioglitazone Actavis
Da Pioglitazone Actavis er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
Because Pioglitazone Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Hvilke fordele og risici er der forbundet med Pioglitazone Actavis?
What are the benefits and risks of Pioglitazone Actavis?
Pioglitazone Actavis indeholder det aktive stof pioglitazon.
Pioglitazone Actavis contains the active substance pioglitazone.
Da Pioglitazone Actavis er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Pioglitazone Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Pioglitazone Actavis udleveres kun efter recept.
Pioglitazone Actavis can only be obtained with a prescription.
Hvad er Pioglitazone Actavis, og hvad anvendes det til?
What is Pioglitazone Actavis and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Pioglitazone Actavis bør anvendes.
It is not intended to provide practical advice on how to use Pioglitazone Actavis.
Hvis du ønsker praktisk vejledning om anvendelsen af Pioglitazone Actavis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Pioglitazone Actavis, patients should read the package leaflet or contact their doctor or pharmacist.
Hvorfor blev Pioglitazone Actavis godkendt?
Why is Pioglitazone Actavis approved?
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pioglitazone Actavis.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pioglitazone Actavis have also been included in the summary of product characteristics and the package leaflet.
Hvordan blev Pioglitazone Actavis undersøgt?
How has Pioglitazone Actavis been studied?
Hvordan anvendes Pioglitazone Actavis?
How is Pioglitazone Actavis used?
Hvordan virker Pioglitazone Actavis?
How does Pioglitazone Actavis work?
Dato for første markedsføringstilladelse: 13 marts 2013 Dato for seneste fornyelse:
Date of first authorisation: 13 March 2013 Date of latest renewal:
Det er vigtigt, at du tager Actelsar HCT hver dag, så længe din læge ikke siger andet.
It is important that you take Actelsar HCT every day until your doctor tells you otherwise.
Ca. 60 % af den orale dosis udskilles i løbet af 48 timer.
About 60% of the oral dose is eliminated within 48 hours.
Du kan tage Actelsar HCT med eller uden mad.
You can take Actelsar HCT with or without food.
Dette kan medføre et permanent synsnedsættelse, hvis det ikke behandles.
This can lead to permanent vision impairment, if not treated.
- Medicin, der indeholder lithium til behandling af visse typer af depression.
- Lithium containing medicines to treat some types of depression.
Telmisartans totale plasmaclearance efter oral administration er >1.500 ml/min.
Total plasma clearance of telmisartan after oral administration is >1500 ml/min.
Den renale clearance er ca. 250-300 ml/min.
Renal clearance is about 250-300 ml/min.
“Lot”, der er trykt på pakningen, henviser til batch nummeret.
“Lot”, which is printed on the carton, refers to the batch number.
- 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.
- Bindevævssygdommen systemisk lupus erythematosus (også kaldet lupus eller SLE), en sygdom, hvor kroppens immunsystem angriber kroppen.
- Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
Individueldosistitrering med hver af de to komponenter anbefales, før der skiftes til den faste dosiskombination.
Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
(Du skal desuden helst undgå at bruge Actelsar HCT tidligt i graviditeten - se afsnittet om Graviditet).
(It is also better to avoid Actelsar HCT in early pregnancy - see pregnancy section).
Det er muligt, at lægen er nødt til at ændre din dosis af disse andre lægemidler eller tage andre forholdsregler.
Your doctor may need to change the dose of these other medicines or take other precautions.
Efter en enkelt dosis 14C-mærket telmisartan repræsenterer glucuronid ca. 11 % af den målte radioaktivitet i plasma.
After a single dose of 14C-labelled telmisartan the glucuronide represents approximately 11% of the measured radioactivity in plasma.
Den terminale eliminationshalveringstid for hydrochlorthiazid er 10-15 timer.
The terminal elimination half-life of hydrochlorothiazide is 10-15 hours.
Hvis fornyet indgift af diuretika er nødvendig, anbefales det at beskytte eksponerede områder mod solen og mod kunstig UVA.
If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Brug af Actelsar HCT sammen med mad og alkohol
Actelsar HCT with food and alcohol
Telmisartans plasmakoncentration er generelt 2-3 gange højere hos kvinder end hos mænd.
Plasma concentrations of telmisartan are generally 2-3 times higher in females than in males.
Trombocytopeni (nogle gange med purpura)
Thrombocytopenia (sometimes with purpura)
Hvis hydrochlorothiazid anvendes under amning, skal dosis holdes så lav som muligt.
If hydrochlorothiazide is used during breast-feeding, doses should be kept as low as possible.
- Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Actelsar HCT” og ”Advarsler og forsigtighedsregler”).
- If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Actelsar HCT” and “Warnings and precautions”).
Den primære behandling omfatter at indstille hydrochlorthiazidbrugen hurtigst muligt.
The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Actelsar HCT kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
Actelsar HCT can have influence on the ability to drive and use machines.
Resumé af sikkerhedsprofilen Den almindeligst rapporterede bivirkning er svimmelhed.
Summary of the safety profile The most commonly reported adverse reaction is dizziness.
Disse kan være symptomer på øget tryk i øjnene og kan forekomme inden for timer til uger fra indtagelsen af Actelsar HCT.
These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Actelsar HCT.
Elimination Telmisartan: Efter enten intravenøs eller oral administration af 14C-mærket telmisartan blev størstedelen af den indgivne dosis (> 97 %) udskilt i fæces via biliær ekskretion.
Elimination Telmisartan: Following either intravenous or oral administration of 14C-labelled telmisartan most of the administered dose (>97%) was eliminated in faeces via biliary excretion.
Selvom der ikke findes kontrollerede epidemiologiske data for angiotensin II-receptorantagonister, kan der være en lignende risiko for denne lægemiddelklasse.
Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Der er utilstrækkelige data fra anvendelse af Actelsar HCT til gravide kvinder.
There are no adequate data from the use of Actelsar HCT in pregnant women.
- Forhøjet aldosteronniveau (vand og salt ophobning i kroppen og ubalance i blodets indhold af mineraler).
- Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
Telmisartan er i høj grad bundet til plasmaproteiner (>99,5 %), hovedsagelig albumin og alfa-Isyreglycoprotein.
Telmisartan is highly bound to plasma proteins (>99.5%) mainly albumin and alpha l-acid glycoprotein.
*Observationen kan være en tilfældighed eller kan være relateret til en mekanisme, som på nuværende tidspunkt ikke er kendt.
*The event may have happened by chance or could be related to a mechanism currently not known.
Derfor forventes det ikke, at bradykininmedierede bivirkninger potenseres.
Therefore, it is not expected to potentiate bradykinin-mediated adverse events.
Øgning af probenecid- eller sulfinpyrazondosis kan være nødvendig.
Increase in dose of probenecid or sulfinpyrazone may be necessary.
Det tilsyneladende fordelingsvolumen for telmisartan er ca. 500 l, hvilket tyder på ekstravævsbinding.
The apparent volume of distribution for telmisartan is approximately 500 litres indicating additional tissue binding.
Det er ikke nødvendigt med dosisjustering.
No dose adjustment is necessary.
Se også information under overskriften ”Tag ikke Actelsar HCT”.
See also information under the heading “Do not take Actelsar HCT”.
Sådanne tilstande bør korrigeres, før behandling med Actelsar HCT initieres.
Such conditions should be corrected before the administration of Actelsar HCT.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
Do not use this medicine after the expiry date which is stated on the carton, blister or bottle label after “EXP”.
Den absolutte biotilgængelighed for telmisartan for 40 mg og 160 mg var hhv. 42 % og 58 %.
The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42% and 58%, respectively.
1 Baseret på erfaringer efter markedsføringen 2 For yderligere beskrivelse, se underpunktet ”Beskrivelse af udvalgte bivirkninger”
1 Based on post-marketing experience 2 For further description, please see sub-section “Description of selected adverse reactions”
Når telmisartan initieres, justeres og seponeres, skal digoxin-niveauerne monitoreres, så niveauerne holdes inden for det terapeutiske område.
When initiating, adjusting, and discontinuing telmisartan, monitor digoxin levels in order to maintain levels within the therapeutic range.
Indeholder tørremiddel, må ikke spises.
Contains desiccant, do not eat.
Baseret på den kumulative nyreudskillelse af hydrochlorthiazid var den absolutte biotilgængelighed ca. 60 %.
Based on cumulative renal excretion of hydrochlorothiazide the absolute bioavailability was about 60%.
En øget forekomst af sepsis er kun set med telmisartan, men kan ikke udelukkes for Actelsar HCT.
Increased incidence of sepsis has been observed with telmisartan only, however it can not be ruled out for Actelsar HCT.
Hyppigheden af bivirkninger var ikke dosisrelateret, og der var ingen korrelation med patienternes køn, alder eller race.
Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Kombinationen af disse stoffer har en additiv antihypertensiv virkning og reducerer blodtrykket i højere grad end de enkelte lægemidler hver for sig.
The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
De fleste tilfælde af unormal leverfunktion/leversygdom fra post marketing erfaring for telmisartan, forekom hos japanske patienter.
Most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
68 % af hydrochlorthiazidet er bundet i plasma, og det tilsyneladende fordelingsvolumen er 0,83-1,14 l/kg.
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83-1.14 l/kg.
For Al/PVC/PVDC blister: 1 år.
For Al/PVC/PVDC blister: 1 year.