natgillin/translations-raw huggingface dataset:
Der blev under den 8-uger lange behandlingsperiode ikke indberettet tilfælde af syncope i nogen af behandlingsgrupperne. 
During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
Se også information under ”Tag ikke CoAprovel”. 
See also information under the heading “Do not take CoAprovel”.
* Disse grænseværdier gælder ikke batcher, hvor mere end ét af ovenstående N-nitrosaminer er identificeret samtidigt; sådanne batcher bør afvises. 
* These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
2) Efter overgangsperioden på to år bør en grænseværdi for NDMA og NDEA på højst 0,03 ppm implementeres. 
2) After the transitional period of 2 years, a limit for NDMA and NDEA of maximum 0.03 ppm should be implemented.
Selvom dette ikke er dokumenteret for CoAprovel, kan der forventes en tilsvarende effekt. 
While this is not documented with CoAprovel, a similar effect should be anticipated.
CoAprovel må ikke gives til børn under 18 år. 
CoAprovel should not be given to children under 18 years of age.
63.09 17404 Riells i Viabrea (Girona) Spanien 
63.09 17404 Riells i Viabrea (Girona) - Spain
Der foreligger ikke specifikke oplysninger om behandling af overdosering med CoAprovel. 
No specific information is available on the treatment of overdose with CoAprovel.
1) De nedenfor angivne grænseværdier for NDMA og NDEA bør implementeres i løbet af en overgangsperiode på to år: 
1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Bivirkninger forbundet med irbesartan alene 
Side effects associated with irbesartan alone
Ældre personer 
Older people
Fødeindtagelse påvirker ikke biotilgængeligheden af CoAprovel. 
Food does not affect the bioavailability of CoAprovel.
Hvis CoAprovel anvendes i ammeperioden, bør dosis være så lav som muligt. 
If CoAprovel is used during breast feeding, doses should be kept as low as possible.
Du skal stoppe behandlingen med CoAprovel og søge lægehjælp. 
You should discontinue CoAprovel treatment and seek medical attention.
På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af det pågældende batch. 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Se punkt 2 ”CoAprovel indeholder lactose” 
Please see section 2 “CoAprovel contains lactose”.
Depression, søvnforstyrrelser 
depression, sleep disturbances
Undersøgelser: 
Investigations:
Børn og unge CoAprovel må ikke gives til børn og unge (under 18 år). 
Children and adolescents CoAprovel should not be given to children and adolescents (under 18 years).
Hyppigheden af uønskede hændelser 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 (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000). 
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).
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.
Dette medfører, at blodtrykket øges. 
This results in an increase in blood pressure.
Aktivt kul kan være nyttig til behandling af overdosering. 
Activated charcoal may be useful in the treatment of overdose.
CoAprovel frarådes til behandling af børn og unge, da sikkerhed og virkning ikke er klarlagt. 
CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Det er vigtigt, at du fortsætter med at tage CoAprovel, indtil lægen siger, du kan stoppe. 
It is important that you continue to take CoAprovel until your doctor tells you otherwise.
Beskyt huden mod sollys og UV- stråler, mens du tager CoAprovel 
Protect your skin from sun exposure and UV rays while taking CoAprovel
Tabletterne skal synkes med en tilstrækkelig mængde væske (for eksempel 1 glas vand). 
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Irbesartans plasma-proteinbindingen 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.
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30°C. 
SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Du kan tage CoAprovel med eller uden mad. 
You can take CoAprovel with or without food.
Hvis du har glemt at tage CoAprovel 
If you forget to take CoAprovel
Det primære formål med forsøget var at sammenligne andelen af patienter hvis SeDBT var kontrolleret (SeDBT < 90 mmHg) 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.
Thrombocytopeni 
thrombocytopenia
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.
Hydrochlorthiazid er 68% proteinbundet i plasma, og dets 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.
2112 Veresegyház - Ungarn 
2112 Veresegyház - Hungary
Hvis behandling med dobbelt hæmning anses for absolut nødvendig, bør det kun udføres under overvågning af specialister og være underlagt hyppig tæt overvågning af nyrefunktionen, elektrolytter og blodtryk. 
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Den anbefalede dosis af CoAprovel er en eller to tabletter dagligt. 
The recommended dose of CoAprovel is one or two tablets a day.
2112 Veresegyhaz Ungarn 
2112 Veresegyhaz Hungary
Indehaverne af markedsføringstilladelse skal sikre, at fremstillingsprocesserne for de stoffer, der anvendes i deres lægemidler, gennemgås for den mulige risiko for dannelse af Nnitrosaminer og ændres i nødvendigt omfang for at minimere nitrosamin-forureningen mest muligt. 
The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Der findes ingen kontrollerede epidemiologiske data vedrørende risikoen med Angiotensin II-ReceptorAntagonister (AIIRAer), men lignende risici kan findes for denne lægemiddelgruppe. 
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Lægen vil forklare, hvordan du skifter fra den tidligere behandling til behandling med CoAprovel. 
Your doctor will instruct you how to switch from the previous treatment to CoAprovel.
Den vigtigste cirkulerende metabolit er glucuronidet af irbesartan (ca. 6%). 
The major circulating metabolite is irbesartan glucuronide (approximately 6%).
Der var ingen tegn på mutagenicitet, clastogenicitet eller karcinogenecitet. 
There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Hypotension - patienter med hypovolæmi: CoAprovel er kun sjældent blevet associeret med symptomatisk hypotension hos hypertensive patienter uden andre risikofaktorer for hypotension. 
Hypotension - Volume-depleted patients: CoAprovel has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Sådanne tilstande skal korrigeres inden initiering af behandling med CoAprovel. 
Such conditions should be corrected before initiating therapy with CoAprovel.
Den anbefalede dosis af CoAprovel er en tablet dagligt. 
The recommended dose of CoAprovel is one tablet a day.
Yderligere information om de individuelle stoffer: Udover ovenfor nævnte bivirkninger for kombinationspræparatet, kan andre tidligere rapporterede bivirkninger i forbindelse med ét af de individuelle stoffer være potentielle bivirkninger ved CoAprovel. 
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with CoAprovel.
Åndenød (inklusive pneumoni og pulmonalt ødem) 
respiratory distress (including pneumonitis and pulmonary oedema)
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.
Irbesartan AUC- og Cmax-værdier var også noget højere hos ældre patienter (≥ 65 år) end hos yngre patienter (18-40 år). 
Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
12% af patienterne var diabetikere, 34% var hyperlipidæmiske, og den hyppigste kardiovaskulære tilstand var stabil angina pectoris hos 3,5% af patienterne. 
Twelve percent (12%) of patients were diabetic, 34% were hyperlipidemic and the most frequent cardiovascular condition was stable angina pectoris in 3.5% of the participants.
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.
Seksuel dysfunktion, ændret libido 
sexual dysfunction, libido changes
CoAprovel påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner. 
CoAprovel is unlikely to affect your ability to drive or use machines.
Irbesartan er en potent, oral aktiv, selektiv angiotensin-II receptor (AT1 undergruppe) antagonist. 
Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Børn og unge må ikke få CoAprovel 
Children should not take CoAprovel
Primær aldosteronisme: Patienter med primær aldosteronisme responderer generelt ikke på antihypertensive stoffer, der virker gennem hæmning af renin-angiotensinsystemet. 
Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
CoAprovel frarådes til ammende mødre, og lægen vil sædvanligvis vælge en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt. 
CoAprovel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Lactose: Patienter med arvelig galactoseintolerans, total laktasemangel eller glukose-galaktose malabsorption bør ikke tage dette lægemiddel. 
Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Graviditet: Behandling med Angiotensin II-Receptor-Antagonister (AIIRAer) bør ikke påbegyndes under graviditet. 
Pregnancy: angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Disse fund er også observeret ved lavere doser af denne anden angiotensin-II antagonist, når den blev givet i kombination med hydrochlorthiazid. 
These findings were also observed with lower doses of this other angiotensin-II antagonist when given in combination with hydrochlorothiazide.
Disse studier viser ikke signifikant gavnlig effekt på nyre og/eller kardiovaskulære resultater og mortalitet, mens en øget risiko for hyperkaliæmi, akut nyreskade og/eller hypotension blev observeret sammenlignet med monoterapi. 
These studies have shown no significant beneficial effect on renal and/or cardiovascular outcomes and mortality, while an increased risk of hyperkalaemia, acute kidney injury and/or hypotension as compared to monotherapy was observed.
Metabolisme og ernæring: 
Metabolism and nutrition disorders:
Der er set begrænset akkumulering af irbesartan (< 20%) i plasma efter gentagne doseringer, 1 gang dagligt. 
Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing.
Ambarès & Lagrave F-33565 Carbon Blanc Cedex - Frankrig 
Ambarès & Lagrave F-33565 Carbon Blanc Cedex - France
VA NEPHRON-D var et studie i patienter med type 2 diabetes mellitus og diabetisk nefropati. 
VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 
STATEMENT OF ACTIVE SUBSTANCES
Artralgi, myalgi 
arthralgia, myalgia
Desuden blev også øget blodurinstof (2,3%), kreatinkinase (1,7%) og kreatinin (1,1%) hyppigt rapporteret i forsøgene. 
In addition, increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Alkohol: Der kan forekomme forstærket ortostatisk hypotension; 
Alcohol: potentiation of orthostatic hypotension may occur;
Aktivt stof* 
Drug substance*
Blod og lymfesystem: 
Blood and lymphatic system disorders:
CoAprovel bør ikke tages i den tidlige graviditet og må ikke tages, hvis du er længere end 3 måneder henne i graviditeten, da det kan skade dit barn alvorligt, hvis det tages efter tredje måned af graviditeten. 
CoAprovel 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.
To store randomiserede, kontrollerede studier (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) og VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) har undersøgt samtidig brug af kombinationen af en ACE-hæmmer og en angiotensin-II-receptorblokker. 
Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Carbamazepin: Samtidig brug af carbamazepin og hydrochlorthiazid har været forbundet med risiko for symptomatisk hyponatriæmi. 
Carbamazepine: concomitant use of carbamazepine and hydrochlorothiazide has been associated with the risk of symptomatic hyponatraemia.
Tag ikke CoAprovel: hvis du er allergisk over for irbesartan eller et af de øvrige indholdsstoffer i CoAprovel (angivet i punkt 6) hvis du er allergisk over for hydrochlorthiazid eller over for sulfonamidholdig medicin hvis du er længere end 3. måned henne i din graviditet. 
Do not take CoAprovel if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines if you are more than 3 months pregnant.
Total body- og nyreclearance er henholdsvis 157-176 og 3-3,5 ml/min. 
The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Virkningen af CoAprovel afhænger ikke af alder eller køn. 
There is no difference in response to CoAprovel, regardless of age or gender.
Foruden de ovennævnte bivirkninger er der også indberettet brystsmerter, alvorlige allergiske reaktioner (anafylaktisk shock), og fald i antallet af blodplader (en blodcelle, der er afgørende for størkning af blodet). 
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Ikke almindelig: Ikke kendt: 
Uncommon: Not known:
Din læge vil normalt anbefale, at du stopper med at tage CoAprovel, inden du bliver gravid, eller så snart du ved, at du er gravid. 
Your doctor will normally advise you to stop taking CoAprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of CoAprovel.
Der var dog ingen forskel i halveringstid og akkumulering. 
However, there was no difference in the half-life and accumulation of irbesartan.
Serum-elektrolytter og kreatinin monitoreres tæt. 
Serum electrolytes and creatinine should be monitored frequently.
Hud og subkutane væv: 
Skin and subcutaneous tissue disorders:
Ved bilkørsel eller betjening af maskiner, skal der tages hensyn til, at der kan opstå svimmelhed eller træthed under behandling. 
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Hvis du har taget for mange CoAprovel Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen. 
If you take more CoAprovel than you should If you accidentally take too many tablets, contact your doctor immediately.
De hyppigst rapporterede bivirkninger var svimmelhed (5,6%), træthed (4,9%), kvalme/opkastning (1,8%) og unormal vandladning (1,4%). 
The most commonly reported ADRs were dizziness (5.6%), fatigue (4.9%), nausea/vomiting (1.8%), and abnormal urination (1.4%).
Non-melanom hudkræft (basalcellekarcinom og pladecellekarcinom) 
non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Valsartan 320 Losartan 150 Olmesartan 40 Irbesartan 300 Candesartan 32 
Olmesartan 40 Irbesartan 300 Candesartan 32
Efter enten oral eller intravenøs administration af 14C irbesartan, genfindes ca. 20% radioaktivitet i urinen og resten i afføringen. 
After either oral or intravenous administration of 14C irbesartan, about 20% of the radioactivity is recovered in the urine,
Ved oral administration af CoAprovel er den absolutte orale biotilgængelighed 60-80% for irbesartan og 50-80% for hydrochlorthiazid. 
Following oral administration of CoAprovel, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Derfor frarådes brug af CoAprovel. 
Therefore, the use of CoAprovel is not recommended.
På baggrund af de farmakodynamiske egenskaber er det usandsynligt, at CoAprovel vil påvirke evnen til at føre motorkøretøj eller betjene maskiner. 
Based on its pharmacodynamic properties, CoAprovel is unlikely to affect the ability to drive and use machines.
Efter oral eller intravenøs administration af 14C irbesartan, kan 80-85% af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan. 
Following oral or intravenous administration of 14C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Den blodtryksnedsættende effekt af irbesartan i kombination med hydrochlorthiazid viser sig efter første dosis og varer ved i 1-2 uger, med maksimal effekt efter 6-8 uger. 
The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 68 weeks.
Brug af CoAprovel sammen med mad og drikke CoAprovel kan tages med og uden mad. 
CoAprovel with food and drink CoAprovel can be taken with or without food.
Indehaverne af markedsføringstilladelse skal for alle N-nitrosaminer sikre, at der indføres en kontrolstrategi for de batcher af stoffer, der anvendes i deres lægemidler. 
For all N-nitrosamines the MAH must ensure a control strategy is in place in drug substance batches used for their drug products.
Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage CoAprovel og straks søge lægehjælp. 
If you get any of the above symptoms or get short of breath, stop taking CoAprovel and contact your doctor immediately.
Angiotensin-II er et stof, der produceres i kroppen, og som binder sig til receptorer i blodårerne og får dem til at trække sig sammen. 
AngiotensinII is a substance produced in the body that binds to receptors in blood vessels causing them to tighten.
Kvalme/opkastning 
nausea/vomiting
CoAprovel frarådes tidligt i graviditeten, og du må ikke tage CoAprovel, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis det tages i denne periode (se afsnittet om graviditet). 
CoAprovel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
CoAprovel bruges til at behandle forhøjet blodtryk, når behandling med irbesartan eller hydrochlorthiazid hver for sig ikke har givet tilstrækkelig kontrol over blodtrykket. 
CoAprovel is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Diarré 
diarrhoea
Der er ingen erfaring med administration af CoAprovel til nyligt nyretransplanterede patienter. 
There is no experience regarding the administration of CoAprovel in patients with a recent kidney transplantation.
Yderligere information om hydrochlorthiazids interaktioner: Ved samtidig administration kan følgende stoffer give anledning til interaktioner med thiaziddiuretika: 
Additional information on hydrochlorothiazide interactions: when administered concurrently, the following medicinal products may interact with thiazide diuretics:
Nedsat leverfunktion: Thiazider skal anvendes med forsigtighed til patienter med nedsat leverfunktion eller progressiv leversygdom, da mindre ændringer af væske- og elektrolytbalancen kan fremskynde hepatisk koma. 
Hepatic impairment: thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Disse læsioner blev ikke observeret hos makakaber;  et fald i serum-kalium på grund af hydrochlorthiazid og delvis forebyggelse, når hydrochlorthiazid blev givet i kombination med irbesartan. 
These lesions were not observed in macaques; decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
56 x 1 tabletter: 
56 x 1 tablets
Antidiabetika (orale stoffer og insuliner): Det kan være nødvendigt at dosisjustere den antidiabetiske behandling (se pkt. 
Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Henholdsvis 0,6% og 0% af patienterne oplevede hypotension og henholdsvis 2,8% og 3,1% oplevede svimmelhed i ved kombinationsbehandling og enkeltstofbehandling. 
There were 0.6% and 0% of patients with hypotension and 2.8% and 3.1% of patients with dizziness as adverse reactions reported in the combination and monotherapy groups, respectively.
Kardiovaskulær død og stroke var begge numerisk hyppigere i aliskirengruppen end i placebogruppen og bivirkninger og alvorlige bivirkninger (hyperkaliæmi, hypotension og nedsat nyrefunktion) var hyppigere rapporteret i aliskiren-gruppen end i placebogruppen. 
Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Andre interaktioner: Den hyperglykæmiske effekt af beta-blokkere og diazoxid kan forstærkes af thiazider. 
Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Selvom hydrochlorthiazid er et sulfonamid, er der kun rapporteret om isolerede tilfælde af akut snævervinklet glaukom med hydrochlorthiazid. 
While hydrochlorothiazide is a sulfonamide, only isolated cases of acute angleclosure glaucoma have been reported so far with hydrochlorothiazide.