FrancophonIA/ELRC3.0 huggingface dataset:
English: Citric acid anhydrous Sodium citrate Microcrystalline cellulose Croscarmellose sodium Sucralose
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Sucralose
English: If you take more Zubsolv than you should
Danish: Hvis du har taget for meget Zubsolv
English: • Drowsiness
Danish: • søvnløshed
English: System Organ
Danish: Immunsystemet
English: After a satisfactory stabilisation has been achieved, if the patient agrees, the dosage may be reduced gradually to a lower maintenance dose; in some favourable cases, treatment may be discontinued.
Danish: Når der er opnået en tilfredsstillende stabilisering, kan doseringen med patientens samtykke gradvist reduceres til en lavere vedligeholdelsesdosis.
English: In comparative bioavailability studies Zubsolv 11.4/2.9 mg displayed equivalent buprenorphine exposure to 16/4mg (2 x 8/2mg) buprenorphine/naloxone administered as conventional sublingual tablets however Zubsolv 2 x 1.4/0.36 mg displayed 20% lower buprenorphine exposure to 2 x 2/0.5 mg buprenorphine/naloxone administered as conventional sublingual tablets.
Danish: I sammenlignende undersøgelser af biotilgængelighed udviste Zubsolv 11,4/2,9 mg en tilsvarende buprenorphineksponering som 16/4 mg (2 x 8/2 mg) buprenorphin/naloxon administreret som konventionelle sublinguale resoribletter.
English: • increased blood pressure, flushing
Danish: • forhøjet blodtryk
English: 1.7-fold increase
Danish: 1,7-folds stigning
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets
Danish: Zubsolv 8,6 mg/2,1 mg sublinguale resoribletter
English: Headache
Danish: Hedeslag
English: - one tablet of Zubsolv 2.9 mg / 0.71 mg each day
Danish: - én Zubsolv resorbilet på 2,9 mg/0,71 mg hver dag.
English: 2.7-fold increase
Danish: 2,7-folds stigning
English: Description of selected adverse reactions
Danish: Beskrivelse af andre udvalgte bivirkninger
English: White, diamond shaped tablets, length 9.5 mm and width 8.2 mm, debossed with “8.6” on one side.
Danish: Hvide, rombeformede resoribletter, længde 9,5 mm og bredde 8,2 mm, præget med “8.6” på den ene side.
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets
Danish: Zubsolv 5,7 mg/1,4 mg sublinguale resoribletter
English: Zubsolv 2.9 mg / 0.71 mg sublingual tablets
Danish: Zubsolv 2,9 mg/0,71 mg sublinguale resoribletter
English: Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicinal product is not safeguarded against theft.
Danish: Denne risiko kan forekomme, hvis den tilsigtede patient ulovligt distribuerer lægemidlet, eller hvis lægemidlet ikke er tilstrækkeligt sikret mod tyveri.
English: 1.6-fold increase
Danish: 1,6-folds stigning
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets
Danish: Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter
English: Liver function test abnormal Weight decreased
Danish: Unormal leverfunktionstest Vægttab
English: • flu-like symptoms, infection, sore throat and painful swallowing, runny nose
Danish: • influenzalignende symptomer, infektion, ondt i halsen og smerter når du synker, løbenæse
English: Amenorrhoea Ejaculation disorder Menorrhagia Metrorrhagia
Danish: Rygsmerter Artralgi Muskelspasmer Myalgi
English: • headache
Danish: • hedeslag
English: 3.2-fold increase
Danish: 3,2-folds stigning
English: Zubsolv 8.6 mg / 2.1 mg sublingual tablets buprenorphine / naloxone
Danish: Zubsolv 8,6 mg/2,1 mg sublinguale resoribletter buprenorphin/naloxon
English: Zubsolv 1.4 mg / 0.36 mg sublingual tablets
Danish: Zubsolv 1,4 mg/0,36 mg sublinguale resoribletter
English: Haematuria
Danish: Urticaria
English: 1.2-fold increase
Danish: 1,2-folds stigning
English: White, diamond shaped tablet, length 9.5 mm and width 8.2 mm
Danish: Hvid, rombeformet resoriblet, længde 9,5 mm og bredde 8,2 mm
English: Zubsolv 11.4 mg / 2.9 mg sublingual tablets buprenorphine / naloxone
Danish: Zubsolv 11,4 mg/2,9 mg sublinguale resoribletter buprenorphin/naloxon
English: Each 8.6 mg / 2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet på 8,6 mg/2,1 mg indeholder 8,6 mg buprenorphin (som hydrochlorid) og 2,1 mg naloxon (som hydrochloriddihydrat).
English: Zubsolv 1.4 mg / 0.36 mg sublingual tablets buprenorphine / naloxone
Danish: Zubsolv 1,4 mg/0,36 mg sublinguale resoribletter buprenorphin/naloxon
English: Zubsolv 11.4 mg / 2.9 mg sublingual tablets
Danish: Zubsolv 11,4 mg/2,9 mg sublinguale resoribletter
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du får alvorlige bivirkninger, skal du straks informere din læge eller omgående søge læge.
English: Tell your doctor immediately or seek urgent medical attention if you experience serious side effects, such as:
Danish: - Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: In rats buprenorphine has been found to inhibit lactation.
Danish: Det er påvist, at buprenorphin hæmmer mælkeproduktionen hos rotter.
English: • excessive sweating
Danish: • stærkt forøget svedtendens
English: Zubsolv 5.7 mg / 1.4 mg sublingual tablets buprenorphine / naloxone
Danish: Zubsolv 5,7 mg/1,4 mg sublinguale resoribletter buprenorphin/naloxon
English: Zubsolv 2.9 mg / 0.71 mg sublingual tablets buprenorphine / naloxone
Danish: Zubsolv 2,9 mg/0,71 mg sublinguale resoribletter buprenorphin/naloxon
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 8,6 mg / 2,1 mg STYRKE
English: Each 1.4 mg / 0.36 mg sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet på 1,4 mg/0,36 mg indeholder 1,4 mg buprenorphin (som hydrochlorid) og 0,36 mg naloxon (som hydrochloriddihydrat).
English: Each 0.7 mg / 0.18 mg sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet på 0,7 mg/0,18 mg indeholder 0,7 mg buprenorphin (som hydrochlorid) og 0,18 mg naloxon (som hydrochloriddihydrat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 0,7 mg / 0,18 mg STYRKE
English: White, triangular tablets, base 7.2 mm and height 6.9 mm, debossed with “1.4” on one side.
Danish: Zubsolv 1,4 mg/0,36 mg sublinguale resoribletter Hvide, trekantede resoribletter, grundlinje 7,2 mm og højde 6,9 mm, præget med “1.4” på den ene side.
English: How to take Zubsolv
Danish: Sådan skal du tage Zubsolv 4.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 8.6 mg / 2.1 mg STRENGTH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 8,6 mg / 2,1 mg STYRKE
English: Each 11.4 mg / 2.9 mg sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet på 11,4 mg/2,9 mg indeholder 11,4 mg buprenorphin (som hydrochlorid) og 2,9 mg naloxon (som hydrochloriddihydrat).
English: Each 5.7 mg / 1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet på 5,7 mg/1,4 mg indeholder 5,7 mg buprenorphin (som hydrochlorid) og 1,4 mg naloxon (som hydrochloriddihydrat).
English: Levomenthol Colloidal anhydrous silica Sodium stearyl fumarate
Danish: Silica, kolloid vandfri Natriumstearylfumarat
English: Hepatitis Hepatitis acute Jaundice Hepatic necrosis Hepatorenal syndrome
Danish: Levernekrose Hepatorenalt syndrom
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Hyperhidrose Pruritus Udslæt
English: Each 2.9 mg / 0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet på 2,9 mg/0,71 mg indeholder 2,9 mg buprenorphin (som hydrochlorid) og 0,71 mg naloxon (som hydrochloriddihydrat).
English: 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.
Danish: Patienter, som er positive for viral hepatitis, og samtidig modtager andre lægemidler (se pkt.
English: 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.
Danish: Patienter, som er positive for viral hepatitis, på samtidige medicinske produkter (se pkt.
English: Each sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet indeholder 11,4 mg buprenorphin (som hydrochlorid) og 2,9 mg naloxon (som hydrochloriddihydrat).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 0.7 mg / 0.18 mg STRENGTH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 0,7 mg / 0,18 mgSTYRKE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 11,4 mg / 2,9 mg STYRKE
English: Each sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet indeholder 8,6 mg buprenorphin (som hydrochlorid) og 2,1 mg naloxon (som hydrochloriddihydrat).
English: Each sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet indeholder 1,4 mg buprenorphin (som hydrochlorid) og 0,36 mg naloxon (som hydrochloriddihydrat).
English: Each sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet indeholder 5,7 mg buprenorphin (som hydrochlorid) og 1,4 mg naloxon (som hydrochloriddihydrat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 5,7 mg / 1,4 mg STYRKE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 5.7 mg / 1.4 mg STRENGTH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 5,7 mg / 1,4 mg STYRKE
English: Each sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet indeholder 2,9 mg buprenorphin (som hydrochlorid) og 0,71 mg naloxon (som hydrochloriddihydrat).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 1,4 mg / 0,36 mg STYRKE
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 2,9 mg / 0,71 mg STYRKE
English: Each sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate).
Danish: Hver sublingual resoriblet indeholder 0,7 mg buprenorphin (som hydrochlorid) og 0,18 mg naloxon (som hydrochloriddihydrat).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 1.4 mg / 0.36 mg STRENGTH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 1,4 mg / 0,36 mg STYRKE
English: • drug withdrawal syndrome
Danish: • Abstinenssymptomer
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 7, 28, and 30 TABLETS 2.9 mg / 0.71 mg STRENGTH
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 2,9 mg / 0,71 mg STYRKE
English: Zubsolv 0.7 mg / 0.18 mg sublingual tablets buprenorphine / naloxone
Danish: Zubsolv 0,7 mg/0,18 mg sublinguale resoribletter buprenorphin/naloxon
English: Migraine Dizziness Hypertonia Paraesthesia Somnolence
Danish: Migræne Svimmelhed Hypertoni Paræstesi Døsighed
English: • back pain, joint pain, muscle pain, leg cramps (muscle spasm)
Danish: • rygsmerter, ledsmerter, muskelsmerter, lægkramper (muskelkramper)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 7, 28, and 30 TABLETS 11.4 mg / 2.9 mg STRENGTH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PAKNINGSSTØRRELSE MED 7, 28, og 30 RESORIBLETTER 11,4 mg / 2,9 mg STYRKE LÆGEMIDLETS NAVN
English: Pruritus Rash Urticaria
Danish: • unormal urin
English: Precipitation of opioid withdrawal syndrome
Danish: Fremkaldelse af opioidabstinenssyndrom
English: Stopping treatment
Danish: Behandlingsstart
English: Asthenia Chest Pain Chills Pyrexia Malaise Pain
Danish: Brystsmerter Kuldegysninger Pyreksi
English: 1.1-fold increase
Danish: 1,1-folds stigning
English: White, oval tablets, length 6.8 mm and width 4.0 mm, debossed with “.7” on one side.
Danish: 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.
English: Depersonalisation Drug dependence Euphoric mood Hostility
Danish: Depersonalisering Lægemiddelafhængigh ed
English: Pack-size of 30 (3 x 10) tablets.
Danish: Pakningsstørrelse 30 (3 x 10) resoribletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Taking Zubsolv
Danish: Sådan skal du tage Zubsolv
English: Abdominal Pain Diarrhoea Dyspepsia Flatulence Vomiting
Danish: Dyspepsi Flatulens Opkastning
English: • Liver damage
Danish: • Leverskade
English: Cough
Danish: Knuder
English: Hypersensitivity Anaphylactic shock
Danish: Anafylaktisk shock
English: Acne
Danish: Akne
English: Injury
Danish: Traumer
English: These measures will help to protect the environment.
Danish: for at beskytte mod fugt.
English: Anxiety
Danish: Angst
English: Class
Danish: Hoste
English: Hepatic impairment
Danish: Hypersensitivitet
English: Date of first authorisation: 26 November 2009 Date of latest renewal: 11 November 2014
Danish: Dato for første markedsføringstilladelse: 26. november 2009 Dato for seneste fornyelse: 11. november 2014
English: You should also tell your doctor:
Danish: Du skal også oplyse lægen om det:
English: However, it should be noted that nitrosamines can also be formed in many other situations, including in biological processes.
Danish: Det bør dog bemærkes, at nitrosaminer også kan dannes i mange andre situationer, herunder i biologiske processer.
English: You may need to have blood checks if you take:
Danish: Det kan være nødvendigt at tage blodprøver, hvis du tager:
English: Your doctor may need to change your dose and/or to take other precautions:
Danish: Det er muligt, at lægen er nødt til at ændre din dosis og/eller tage andre forholdsregler:
English: However the terminal half-life was not significantly altered.
Danish: Den terminale halveringstid ændredes dog ikke signifikant.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Danish: Patienten skal monitoreres tæt, og behandlingen skal være symptomatisk og understøttende.
English: Compared to the lifetime cancer risk in the European population of approximately 50%, this additional risk is considered to be very low.
Danish: Sammenholdt med kræftrisikoen ved livslang eksponering i den europæiske befolkning på ca. 50 % anses denne yderligere risiko som meget lav.
English: Treatment of essential hypertension.
Danish: Behandling af essentiel hypertension.
English: Considerations on monitoring of exposed patients
Danish: Overvejelser vedrørende monitorering af eksponerede patienter
English: This is the background to the current referral procedure.
Danish: Dette er baggrunden for indbringelsesproceduren.
English: Assessment of the excess risk of cancer
Danish: Vurdering af den forhøjede risiko for kræft
English: Try to take your daily dose at about the same time each day.
Danish: Prøv at tage medicinen på ca. samme tidspunkt hver dag.
English: if you have difficulty in producing urine.
Danish: • hvis du har problemer med urinproduktionen.
English: Other interactions
Danish: Andre interaktioner
English: The mean age of patients was 52.5 years, 13 % were ≥ 65 years of age, and just 2 % were ≥ 75 years of age.
Danish: Patienternes gennemsnitsalder var 52,5 år; 13 % var ≥ 65 år, og kun 2 % var ≥ 75 år.
English: Some of these effects may be serious and may require medical attention.
Danish: Nogle af bivirkningerne kan dog være alvorlige og kan kræve medicinsk behandling.
English: 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:
Danish: 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:
English: If possible, another class of diuretics should be used;
Danish: Hvis det er muligt, bør der anvendes diuretika af en anden klasse;
English: These lesions were not observed in macaques;
Danish: Disse læsioner blev ikke observeret hos makakaber;
English: Appropriate regulatory actions (such as quarantine or batch recalls) have been taken where relevant.
Danish: Hensigtsmæssige regulatoriske tiltag (f.eks. karantæne eller batchtilbagekaldelse) er iværksat, hvor det er relevant.
English: Primary aldosteronism
Danish: Primær aldosteronisme
English: During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
Danish: Der blev under den 8-uger lange behandlingsperiode ikke indberettet tilfælde af synkope i nogen af behandlingsgrupperne.
English: The most common signs and symptoms of overdose are nausea and somnolence.
Danish: De mest almindelige tegn og symptomer på overdosering er kvalme og somnolens.
English: The combination should be administered with caution, especially in the elderly.
Danish: Der skal udvises forsigtighed, når denne kombination anvendes, især hos ældre.
English: Modifying manufacturing processes, where necessary, to minimise contamination as much as possible.
Danish: Modificering af fremstillingsprocesser, hvor det måtte være nødvendigt, for at minimere forureningen mest muligt.
English: Based on all available data, the CHMP requires the following:
Danish: På grundlag af de tilgængelige data indfører CHMP følgende krav:
English: NDMA and NDEA are two of the most potent mutagenic carcinogens known.
Danish: NDMA og NDEA er to af de mest potente mutagene karcinogener, der kendes.
English: This results in an increase in blood pressure.
Danish: Det medfører, at blodtrykket øges.
English: This limit is considered a sufficiently robust threshold for APIs that can technically be reached.
Danish: Denne grænse anses for at være en tilstrækkeligt solid grænseværdi for aktive stoffer, der teknisk kan lade sig gøre.
English: For these reasons, CHMP could not identify cancer screening methods that patients would benefit from.
Danish: CHMP kunne således ikke identificere nogen kræftscreeningsmetode, som patienterne ville have gavn af.
English: The maximal blood pressure lowering effect should be reached 6-8 weeks after beginning treatment.
Danish: Den maksimale blodtrykssænkende effekt nås 6-8 uger efter behandlingen er påbegyndt.
English: 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.
Danish: 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.
English: The primary treatment is to discontinue drug intake as rapidly as possible.
Danish: Primær behandling er seponering af lægemidlet så hurtigt som muligt.
English: Additional measures are needed to minimise prospectively the reoccurrence of such contamination.
Danish: Yderligere foranstaltninger er nødvendige for fremadrettet at minimere fornyet forekomst af sådan forurening.
English: However, there was no difference in the half-life and accumulation of irbesartan.
Danish: Der var dog ingen forskel i halveringstid og akkumulering af irbesartan.
English: The ICH M7(R1) guideline sets out principles for determining limits for mutagenic / DNA-reactive impurities.
Danish: ICH M7 (R1)-retningslinjerne fastsætter principper for bestemmelse af grænseværdier for mutagene/DNA-reaktive urenheder.
English: Specifically, CHMP considered that NDMA and NDEA limits should be as low as technically possible.
Danish: CHMP vurderede mere specifikt, at NDMA- og NDEA-grænseværdierne bør være så lave som teknisk muligt.
English: No data are available..
Danish: Der foreligger ingen data.
English: Electrolytes should be monitored during concomitant use.
Danish: Elektrolytter bør monitoreres ved samtidig brug.
English: Max. daily dose (mg)
Danish: Maksimal daglig dosis (mg)
English: The impact of NDMA and NDEA on human health is currently only extrapolated from animal studies.
Danish: Indvirkningen af NDMA og NDEA på menneskers sundhed er i øjeblikket kun ekstrapoleret fra dyrestudier.
English: Chloride deficit is generally mild and usually does not require treatment.
Danish: Kloridmangel er generelt beskeden og kræver normalt ingen behandling.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Efficacy and safety of sartancontaining medicines in these indications are per se well-established and are not questioned in this referral.
Danish: Virkningen og sikkerheden ved sartan-holdige lægemidler i disse indikationer er som sådan velkendte og betvivles ikke i denne indbringelsesprocedure.
English: 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.
Danish: 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.
English: At least 61 % of the oral dose is eliminated unchanged within 24 hours.
Danish: Mindst 61 % af den orale dosis udskilles uomdannet inden for 24 timer.
English: Activated charcoal may be useful in the treatment of overdose.
Danish: Aktivt kul kan være nyttigt til behandling af overdosering.
English: Depression, sleep disturbances
Danish: Depression, søvnforstyrrelser
English: 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.
Danish: 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.