natgillin/translations-raw huggingface dataset:
Hver sublingual resoriblet på 5,7 mg/1,4 mg indeholder 5,7 mg buprenorphin (som hydrochlorid) og 1,4 mg naloxon (som hydrochloriddihydrat). 
Each 5.7 mg / 1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Silica, kolloid vandfri Natriumstearylfumarat 
Levomenthol Colloidal anhydrous silica Sodium stearyl fumarate
Levernekrose Hepatorenalt syndrom 
Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome
Hud og subkutane væv Hyperhidrose Pruritus Udslæt 
Skin and subcutaneous tissue disorders
Hver sublingual resoriblet på 2,9 mg/0,71 mg indeholder 2,9 mg buprenorphin (som hydrochlorid) og 0,71 mg naloxon (som hydrochloriddihydrat). 
Each 2.9 mg / 0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Patienter, som er positive for viral hepatitis, og samtidig modtager andre lægemidler (se pkt. 
Patients who are positive for viral hepatitis, receiving concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Patienter, som er positive for viral hepatitis, på samtidige medicinske produkter (se pkt. 
Patients who are positive for viral hepatitis, on concomitant medicinal products (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.
Hver sublingual resoriblet indeholder 11,4 mg buprenorphin (som hydrochlorid) og 2,9 mg naloxon (som hydrochloriddihydrat). 
Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 0,7 mg / 0,18 mgSTYRKE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 11,4 mg / 2,9 mg STYRKE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Hver sublingual resoriblet indeholder 8,6 mg buprenorphin (som hydrochlorid) og 2,1 mg naloxon (som hydrochloriddihydrat). 
Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Hver sublingual resoriblet indeholder 1,4 mg buprenorphin (som hydrochlorid) og 0,36 mg naloxon (som hydrochloriddihydrat). 
Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Hver sublingual resoriblet indeholder 5,7 mg buprenorphin (som hydrochlorid) og 1,4 mg naloxon (som hydrochloriddihydrat). 
Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 5,7 mg / 1,4 mg STYRKE 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 5,7 mg / 1,4 mg STYRKE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Hver sublingual resoriblet indeholder 2,9 mg buprenorphin (som hydrochlorid) og 0,71 mg naloxon (som hydrochloriddihydrat). 
Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 1,4 mg / 0,36 mg STYRKE 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 2,9 mg / 0,71 mg STYRKE 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Hver sublingual resoriblet indeholder 0,7 mg buprenorphin (som hydrochlorid) og 0,18 mg naloxon (som hydrochloriddihydrat). 
Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 1,4 mg / 0,36 mg STYRKE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
• Abstinenssymptomer 
• drug withdrawal syndrome
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 2,9 mg / 0,71 mg STYRKE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter buprenorphin/naloxon 
Zubsolv 0.7 mg / 0.18 mg sublingual tablets buprenorphine / naloxone
Migræne Svimmelhed Hypertoni Paræstesi Døsighed 
Migraine Dizziness Hypertonia Paraesthesia Somnolence
• rygsmerter, ledsmerter, muskelsmerter, lægkramper (muskelkramper) 
• back pain, joint pain, muscle pain, leg cramps (muscle spasm)
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 11,4 mg / 2,9 mg STYRKE LÆGEMIDLETS NAVN 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
• unormal urin 
Pruritus Rash Urticaria
Fremkaldelse af opioidabstinenssyndrom 
Precipitation of opioid withdrawal syndrome
Behandlingsstart 
Stopping treatment
Brystsmerter Kuldegysninger Pyreksi 
Asthenia Chest Pain Chills Pyrexia Malaise Pain
1,1-folds stigning 
1.1-fold increase
Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter Hvide, ovale resoribletter, længde 6,8 mm og bredde 4,0 mm, præget med “.7” på den ene side. 
White, oval tablets, length 6.8 mm and width 4.0 mm, debossed with “.7” on one side.
Depersonalisering Lægemiddelafhængigh ed 
Depersonalisation Drug dependence Euphoric mood Hostility
Pakningsstørrelse 30 (3 x 10) resoribletter Ikke alle pakningsstørrelser er nødvendigvis markedsført. 
Pack-size of 30 (3 x 10) tablets.
Sådan skal du tage Zubsolv 
Taking Zubsolv
Dyspepsi Flatulens Opkastning 
Abdominal Pain Diarrhoea Dyspepsia Flatulence Vomiting
• Leverskade 
• Liver damage
Knuder 
Cough
Anafylaktisk shock 
Hypersensitivity Anaphylactic shock
Akne 
Acne
Traumer 
Injury
for at beskytte mod fugt. 
These measures will help to protect the environment.
Angst 
Anxiety
Hoste 
Class
Hypersensitivitet 
Hepatic impairment
Dato for første markedsføringstilladelse: 26. november 2009 Dato for seneste fornyelse: 11. november 2014 
Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014
Du skal også oplyse lægen om det: 
You should also tell your doctor:
Det bør dog bemærkes, at nitrosaminer også kan dannes i mange andre situationer, herunder i biologiske processer. 
However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes.
Det kan være nødvendigt at tage blodprøver, hvis du tager: 
You may need to have blood checks if you take:
Det er muligt, at lægen er nødt til at ændre din dosis og/eller tage andre forholdsregler: 
Your doctor may need to change your dose and/or to take other precautions:
Den terminale halveringstid ændredes dog ikke signifikant. 
However the terminal half-life was not significantly altered.
Patienten skal monitoreres tæt, og behandlingen skal være symptomatisk og understøttende. 
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Sammenholdt med kræftrisikoen ved livslang eksponering i den europæiske befolkning på ca. 50 % anses denne yderligere risiko som meget lav. 
Compared to the lifetime cancer risk in the European population of approximately 50%, this additional risk is considered to be very low.
Behandling af essentiel hypertension. 
Treatment of essential hypertension.
Overvejelser vedrørende monitorering af eksponerede patienter 
Considerations on monitoring of exposed patients
Dette er baggrunden for indbringelsesproceduren. 
This is the background to the current referral procedure.
Vurdering af den forhøjede risiko for kræft 
Assessment of the excess risk of cancer
Prøv at tage medicinen på ca. samme tidspunkt hver dag. 
Try to take your daily dose at about the same time each day.
• hvis du har problemer med urinproduktionen. 
if you have difficulty in producing urine.
Andre interaktioner 
Other interactions
Patienternes gennemsnitsalder var 52,5 år; 13 % var ≥ 65 år, og kun 2 % var ≥ 75 år. 
The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age.
Nogle af bivirkningerne kan dog være alvorlige og kan kræve medicinsk behandling. 
Some of these effects may be serious and may require medical attention.
Disse midlertidige grænseværdier er baseret på den maksimale daglige dosis, der er tilladt i EU, for hver af sartanerne og er derfor forskellig for hver enkelt af dem som angivet i tabellen nedenfor: 
These interim limits are based on the maximum daily dose authorised in the EU for each of the sartans and therefore vary between them, as outlined in the table below:
Hvis det er muligt, bør der anvendes diuretika af en anden klasse; 
If possible, another class of diuretics should be used;
Disse læsioner blev ikke observeret hos makakaber; 
These lesions were not observed in macaques;
Hensigtsmæssige regulatoriske tiltag (f.eks. karantæne eller batchtilbagekaldelse) er iværksat, hvor det er relevant. 
Appropriate regulatory actions (such as quarantine or batch recalls) have been taken where relevant.
Primær aldosteronisme 
Primary aldosteronism
Der blev under den 8-uger lange behandlingsperiode ikke indberettet tilfælde af synkope i nogen af behandlingsgrupperne. 
During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
De mest almindelige tegn og symptomer på overdosering er kvalme og somnolens. 
The most common signs and symptoms of overdose are nausea and somnolence.
Der skal udvises forsigtighed, når denne kombination anvendes, især hos ældre. 
The combination should be administered with caution, especially in the elderly.
Modificering af fremstillingsprocesser, hvor det måtte være nødvendigt, for at minimere forureningen mest muligt. 
Modifying manufacturing processes, where necessary, to minimise contamination as much as possible.
På grundlag af de tilgængelige data indfører CHMP følgende krav: 
Based on all available data, the CHMP requires the following:
NDMA og NDEA er to af de mest potente mutagene karcinogener, der kendes. 
NDMA and NDEA are two of the most potent mutagenic carcinogens known.
Det medfører, at blodtrykket øges. 
This results in an increase in blood pressure.
Denne grænse anses for at være en tilstrækkeligt solid grænseværdi for aktive stoffer, der teknisk kan lade sig gøre. 
This limit is considered a sufficiently robust threshold for APIs that can technically be reached.
CHMP kunne således ikke identificere nogen kræftscreeningsmetode, som patienterne ville have gavn af. 
For these reasons, CHMP could not identify cancer screening methods that patients would benefit from.
Den maksimale blodtrykssænkende effekt nås 6-8 uger efter behandlingen er påbegyndt. 
The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Det underliggende koncept for den foreslåede tilgang er at holde mængden af N-nitrosamin-urenheder så lav som muligt, uanset typen af sartan eller dosis. 
The underlying concept of the proposed approach is to keep the amount of N-nitrosamine impurities as low as possible, irrespective of the type of sartan or dose.
Primær behandling er seponering af lægemidlet så hurtigt som muligt. 
The primary treatment is to discontinue drug intake as rapidly as possible.
Yderligere foranstaltninger er nødvendige for fremadrettet at minimere fornyet forekomst af sådan forurening. 
Additional measures are needed to minimise prospectively the reoccurrence of such contamination.
Der var dog ingen forskel i halveringstid og akkumulering af irbesartan. 
However, there was no difference in the half-life and accumulation of irbesartan.
ICH M7 (R1)-retningslinjerne fastsætter principper for bestemmelse af grænseværdier for mutagene/DNA-reaktive urenheder. 
The ICH M7(R1) guideline sets out principles for determining limits for mutagenic / DNA-reactive impurities.
CHMP vurderede mere specifikt, at NDMA- og NDEA-grænseværdierne bør være så lave som teknisk muligt. 
Specifically, CHMP considered that NDMA and NDEA limits should be as low as technically possible.
Der foreligger ingen data. 
No data are available..
Elektrolytter bør monitoreres ved samtidig brug. 
Electrolytes should be monitored during concomitant use.
Maksimal daglig dosis (mg) 
Max. daily dose (mg)
Indvirkningen af NDMA og NDEA på menneskers sundhed er i øjeblikket kun ekstrapoleret fra dyrestudier. 
The impact of NDMA and NDEA on human health is currently only extrapolated from animal studies.
Kloridmangel er generelt beskeden og kræver normalt ingen behandling. 
Chloride deficit is generally mild and usually does not require treatment.
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Virkningen og sikkerheden ved sartan-holdige lægemidler i disse indikationer er som sådan velkendte og betvivles ikke i denne indbringelsesprocedure. 
Efficacy and safety of sartancontaining medicines in these indications are per se well-established and are not questioned in this referral.
Da de DNA-skadelige mekanismer, der er dokumenteret i disse studier, imidlertid også er relevante hos mennesker, og in vitro-data for menneskeceller ikke er væsentligt forskellige fra in vitro-data for dyreceller, er det rimeligt at antage, at virkninger set hos dyr også kan forekomme hos mennesker efter eksponering for tilstrækkeligt store mængder af disse nitrosaminer. 
However, as the DNA damage mechanisms documented in these studies are also relevant in humans and in vitro data in human cells are not significantly different from those in animal cells, it is prudent to assume that effects seen in animals may also occur in humans after exposure to sufficiently large amounts of these nitrosamines.
Mindst 61 % af den orale dosis udskilles uomdannet inden for 24 timer. 
At least 61 % of the oral dose is eliminated unchanged within 24 hours.
Aktivt kul kan være nyttigt til behandling af overdosering. 
Activated charcoal may be useful in the treatment of overdose.
Depression, søvnforstyrrelser 
Depression, sleep disturbances
Så snart problemet med nitrosamin-forurening blev kendt, blev der truffet øjeblikkelige forsigtighedsforanstaltninger af de kompetente myndigheder i hele EU, herunder tilbagekaldelse af berørte batcher fra apoteker. 
As soon as the problem of nitrosamine-contamination became known, immediate, precautionary measures were taken by competent authorities across the EU such as recalls of affected batches from pharmacies.
Tabletterne skal synkes med en tilstrækkelig mængde væske (for eksempel et glas vand). 
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
I begyndelsen var det kun nødvendigt for valsartan-holdige aktive stoffer fra få fremstillere, men senere blev det også nødvendigt for visse andre sartaner med en tetrazolring. 
Initially, this was only necessary for valsartan containing APIs from few manufacturers but later also for some other sartans with a tetrazole ring.
Der blev ikke observeret signifikante forandringer af antallet af corpora lutea, implantater eller levende fostre. 
No significant effects on the number of corpora lutea, implants, or live foetuses were observed.
Metabolisk og endokrin virkning 
Metabolic and endocrine effects
Derudover sås det, at fremskreden alder, komorbiditet og brug af antikoagulanter var tæt forbundet med både gastrointestinale og ikkegastrointestinale komplikationer. 
In addition, advancing age, comorbidity and use of anticoagulants were found to be strongly associated with both gastrointestinal and non-gastrointestinal complications.
Irbesartan påvirkede ikke overlevelse, udvikling eller reproduktion af afkommet. 
Irbesartan did not affect survival, development, or reproduction of offspring.
Desuden er målorganerne for NDMA/NDEA-toksicitet hos mennesker stadig ikke tilstrækkeligt klarlagt. 
Furthermore, the target organ(s) of NDMA/NDEA toxicity in humans are still not sufficiently clear.
Hydrochlorthiazid bør ikke anvendes til essentiel hypertension hos gravide kvinder, undtagen i sjældne tilfælde, hvor ingen anden behandling kan anvendes. 
Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
For at kunne foretage en risikovurdering på individuelt plan ville det være nødvendigt at have adgang til data om de præcise lægemidler og batcher, som hver enkelt patient har anvendt. 
For an individual risk assessment, data on the exact drug products and batches used by each individual patient would be necessary.
Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ } 
This leaflet was last revised in {MM/YYYY}.
Seksuel dysfunktion, ændret libido 
Sexual dysfunction, libido changes
I langsigtede opfølgningsstudier blev virkningen af irbesartan/hydrochlorthiazid opretholdt i mere end 1 år. 
In long-term follow-up studies, the effect of irbesartan/hydrochlorothiazide was maintained for over one year.
Irbesartans plasma-proteinbinding er ca. 96 %, med en ubetydelig binding til cellulære blodkomponenter. 
Plasma protein binding of irbesartan is approximately 96%, with negligible binding to cellular blood components.
Ikke anvendte lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer. 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Mistænkelige hudlæsioner bør straks undersøges, herunder eventuelt ved hjælp af histologisk biopsianalyse. 
Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.
• En toårig overgangsperiode anses som acceptabel for at ændre fremstillingsprocesserne og opnå synteser, hvor N-nitrosaminer ikke dannes, vedtage analysemetoder til kontrolstrategien og undgå produktknaphed. 
• A two-year transition period) is considered acceptable to change production processes to achieve syntheses in which N-nitrosamines are not formed, to adopt analytical methods for the control strategy and in order to avoid product shortages.
Risici, der opstår som følge af gentagen eksponering, anses for at være additive hos patienter, eftersom mutagene karcinogener aktuelt anses som summation toxins. 
Risks resulting from multiple exposures are considered to add up in patients as mutagenic carcinogens are currently considered as summation toxins.
Steady-state plasmakoncentration nås i løbet af 3 dage efter påbegyndelse af behandling 1 gang dagligt. 
Steady-state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.
Dobbelt hæmning af renin-angiotensin-aldosteron-systemet (RAAS) 
Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Der blev ikke observeret toksikologiske fund med relevans for human terapeutisk anvendelse. 
There were no toxicological findings observed of relevance to human therapeutic use.
Alle disse ændringer ansås for at være forårsaget af irbesartans farmakologiske virkning. 
All of these changes were considered to be caused by the pharmacological action of irbesartan.
Hydrochlorthiazid er 68 % proteinbundet i plasma, og dets tilsyneladende fordelingsvolumen er 0,83-1,14 l/kg. 
Hydrochlorothiazide is 68% proteinbound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Derimod har en anden angiotensin-II-antagonist påvirket fertilitetsparametre i dyrestudier, når denne blev givet alene. 
However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone.
Det er ukendt, om irbesartan eller dets metabolitter udskilles i human mælk. 
It is unknown whether irbesartan or its metabolites are excreted in human milk.
Ved bilkørsel eller betjening af maskiner, skal der tages hensyn til, at der lejlighedsvis kan opstå svimmelhed eller træthed under behandling af hypertension. 
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Dosisjustering er ikke nødvendig hos kvindelige patienter. 
No dosage adjustment is necessary in female patients.
Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden 
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Mindre end 2 % af dosis udskilles uomdannet i urinen som irbesartan. 
Less than 2 % of the dose is excreted in the urine as unchanged irbesartan.
Den terminale halveringstid for irbesartan er 11-15 timer. 
The terminal elimination half-life of irbesartan is 11-15 hours.
Selvom foranstaltningerne er fokuseret på NDMA og NDEA, bør principperne vedrørende toksikologisk vurdering, kontrolstrategi og ændringer af fremstillingsprocessen for stoffer i denne procedure anvendes analogt på andre nitrosaminer. 
Whilst the measures are focused on NDMA and NDEA, the principles used in this procedure in terms of toxicology assessment, control strategy and changes to the manufacturing processes for drug substances should be applied by analogy to other nitrosamines.
Derfor bør forekomsten af N-nitrosamin-urenheder i lægemidler som f.eks. sartaner, der er beregnet til langvarig brug, reduceres mest muligt. 
For these reasons, N-nitrosamine impurities in pharmaceuticals such as sartans intended for long-term use should be reduced as much as possible.
Den førnævnte meget lave teoretiske risiko skal afvejes mod risiciene ved potentielle foranstaltninger til monitorering af patienter som f.eks. koloskopi eller gastroskopi, der kan overstige den teoretiske forhøjede risiko for kræft. 
The above stated very small theoretical risk has to be balanced against the risks of potential measures to monitor patients such as colonoscopy or gastroscopy which may exceed the theoretical excess cancer risk.
Det primære formål med forsøget var at sammenligne andelen af patienter hvis SeDBT var kontrolleret (SeDBT < 90 mm Hg) ved Uge 5. 
The primary objective of this study was to compare the proportion of patients whose SeDBP was controlled (SeDBP < 90 mmHg) at Week 5 of treatment.
Hydrochlorthiazid udskilles i små mængder i human mælk. 
Hydrochlorothiazide is excreted in human milk in small amounts.
Prægelatineret stivelse (majs) Poloxamer 188 
Pregelatinized starch (maize) Poloxamer 188
Den vigtigste cirkulerende metabolit er glucuronidet af irbesartan (ca. 6 %). 
The major circulating metabolite is irbesartan glucuronide (approximately 6 %).
• hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen. 
- aliskiren if you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
• CHMP gennemgik data for kvalitet vedrørende fremstillingsprocesserne for sartaner med en tetrazolgruppe, analysedata, herunder testresultater og tilgængelige metoder, og toksikologiske data for de N-nitrosaminer, der er til stede i nogle af disse produkter. 
• The CHMP reviewed data on quality regarding the manufacturing processes of sartans with a tetrazole group, analytical data including test results and available methods, and toxicological data available for the N-nitrosamines found in some of these products.