FrancophonIA/ELRC3.0 huggingface dataset:
English: What PritorPlus contains
Danish: PritorPlus indeholder:
English: PritorPlus fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide and 80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
Danish: Fastdosiskombinationen PritorPlus (40 mg telmisartan/12,5 mg hydrochlorthiazid og 80 mg telmisartan/12,5 mg hydrochlorthiazid) er indiceret til voksne, hvis blodtryk ikke kan reguleres tilfredsstillende med telmisartan alene.
English: The overall incidence of adverse reactions reported with PritorPlus was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Danish: I randomiserede, kontrollerede forsøg med alt i alt 1471 patienter, var den totale rapporterede forekomst af bivirkninger ved brug af PritorPlus (835 patienter) sammenlignelig med forekomsten for telmisartan alene (636 patienter).
English: • PritorPlus 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Pritor 40 mg
Danish: • PritorPlus 40 mg/12,5 mg én gang dagligt er til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med Pritor 40 mg
English: MARKETING AUTHORISATION NUMBER(S) PritorPlus 40 mg/12.5 mg tablets EU/1/02/215/001-005, 011, 013
Danish: PritorPlus 40 mg/12,5 mg tabletter EU/1/02/215/001-005, 011, 013
English: You can take PritorPlus with or without food.
Danish: Brug af PritorPlus sammen med mad og alkohol Du kan tage PritorPlus med eller uden mad.
English: What you need to know before you take PritorPlus
Danish: Det skal du vide, før du begynder at tage PritorPlus
English: You should store your medicine in the original package in order to protect the tablets from moisture.
Danish: Du skal opbevare PritorPlus i den originale yderpakning for at beskytte tabletterne mod fugt.
English: PritorPlus is not indicated in patients with severe hepatic impairment.
Danish: PritorPlus må ikke gives til patienter med svært nedsat leverfunktion.
English: - Hyponatraemia and hypochloraemic alkalosis There is no evidence that PritorPlus would reduce or prevent diuretic-induced hyponatraemia.
Danish: Der er intet, der tyder på, at PritorPlus kan reducere eller forhindre diuretika forårsaget hyponatriæmi.
English: Adverse reactions previously reported with one of the individual components may be potential adverse reactions with PritorPlus, even if not observed in clinical trials with this product.
Danish: Yderligere oplysninger om de enkelte komponenter Tidligere rapporterede bivirkninger for de enkelte indholdsstoffer kan også være potentielle bivirkninger i forbindelse med PritorPlus, selvom de ikke er observeret i kliniske forsøg med dette produkt.
English: PritorPlus 80 mg/12.5 mg tablets
Danish: PritorPlus 80 mg/12,5 mg tabletter
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking PritorPlus.
Danish: Du skal derfor tale med din læge om eventuelt at få ændret doseringen af din medicin.
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (See section 5.3).
Danish: Behandling i andet og tredje trimester med angiotensin II-receptorantagonister kan medføre human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, forsinkelse af knogledannelsen i kraniet) og neonatal toksicitet (nyresvigt, hypotension, hyperkaliæmi).
English: • PritorPlus 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Pritor 80 mg
Danish: • PritorPlus 80 mg/12,5 mg én gang dagligt er til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med Pritor 80 mg.
English: The effect of PritorPlus may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen).
Danish: Blodtrykssænkningen med PritorPlus kan blive mindre ved samtidig brug af medicin mod gigt og lette smerter (non-steroid antiinflammatorisk medicin (NSAID)), f.eks. acetylsalicylsyre eller ibuprofen.
English: PritorPlus 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).
Danish: Hvis PritorPlus tages mere end 3 måneder henne i graviditeten, kan det forårsage alvorlige fosterskader (se afsnit Graviditet).
English: PritorPlus should not be given to patients with cholestasis, biliary obstructive disorders or severe hepatic insufficiency (see section 4.3) since telmisartan is mostly eliminated with the bile.
Danish: PritorPlus bør ikke gives til patienter med kolestase, biliære obstruktive sygdomme eller svær leverinsufficiens (se pkt.
English: How to take PritorPlus
Danish: Sådan skal du tage PritorPlus
English: Adverse reactions reported with one of the individual components may be potential adverse reactions with PritorPlus, even if not observed in clinical trials with this product.
Danish: Nedenstående bivirkninger, der er blevet rapporteret for de to aktive indholdsstoffer, er også mulige bivirkninger for PritorPlus, selvom de ikke er set i kliniske studier med dette lægemiddel.
English: NAME OF THE MEDICINAL PRODUCT PritorPlus 80 mg/25 mg tablets
Danish: LÆGEMIDLETS NAVN PritorPlus 80 mg/25 mg tabletter
English: INFORMATION IN BRAILLE PritorPlus 80 mg/25 mg
Danish: INFORMATION I BRAILLESKRIFT PritorPlus 80 mg/25 mg
English: Gastrointestinal disorders Common:
Danish: Gastrointestinalt ubehag
English: EU/1/02/215/015 14 tablets EU/1/02/215/016 28 tablets EU/1/02/215/017 28 x 1 tablets EU/1/02/215/018 30 tablets EU/1/02/215/019 56 tablets EU/1/02/215/020 90 tablets EU/1/02/215/021 98 tablets
Danish: EU/1/02/215/015 14 tabletter EU/1/02/215/016 28 tabletter EU/1/02/215/017 28 x 1 tabletter EU/1/02/215/018 30 tabletter EU/1/02/215/019 56 tabletter EU/1/02/215/020 90 tabletter EU/1/02/215/021 98 tabletter
English: PritorPlus is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg Renal impairment
Danish: PritorPlus findes også i styrkerne 40 mg/12,5 mg og 80 mg/12,5 mg.
English: PritorPlus 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by PritorPlus 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Danish: • PritorPlus 80 mg/25 mg én gang dagligt kan gives til patienter, hvis blodtryk ikke kan reguleres tilfredsstillende med PritorPlus 80 mg/12,5 mg eller til patienter, som tidligere er stabiliseret på telmisartan og hydrochlorothiazid givet hver for sig.
English: PritorPlus is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by PritorPlus 80/12.5 mg or in adults who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.
Danish: PritorPlus bruges til at sænke forhøjet blodtryk (essentiel hypertension) hos voksne, hvis blodtryk ikke kan reguleres tilfredsstillende med PritorPlus 80 mg/12,5 mg eller til patienter, som tidligere er stabiliseret på telmisartan og hydrochlorothiazid givet hver for sig.
English: INFORMATION IN BRAILLE PritorPlus 40 mg/12.5 mg
Danish: INFORMATION I BRAILLESKRIFT PritorPlus 40 mg/12,5 mg
English: EU/1/02/215/001 14 tablets EU/1/02/215/002 28 tablets EU/1/02/215/003 28 x 1 tablets EU/1/02/215/013 30 tablets EU/1/02/215/004 56 tablets EU/1/02/215/011 90 tablets EU/1/02/215/005 98 tablets
Danish: EU/1/02/215/001 14 tabletter EU/1/02/215/002 28 tabletter EU/1/02/215/003 28 x 1 tabletter EU/1/02/215/013 30 tabletter EU/1/02/215/004 56 tabletter EU/1/02/215/011 90 tabletter EU/1/02/215/005 98 tabletter
English: Lithium containing medicines to treat some types of depression.
Danish: - Medicin, der indeholder lithium til behandling af visse typer af depression - Medicin, der kan forårsage lavt kaliumindhold i blodet (hypokaliæmi).
English: PritorPlus is available in blisters packs containing 14, 28, 30, 56, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Danish: PritorPlus er pakket i blisterpakninger med 14, 28, 30, 56, 90 eller 98 tabletter eller enkelt dosis blister pakninger indeholdende 28 x 1 tabletter.
English: - see pregnancy section.)
Danish: PritorPlus tidligt i graviditeten - se afsnittet om Graviditet)
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of PritorPlus, hyperkalaemia might occur.
Danish: Omvendt kan hyperkaliæmi optræde på grund af telmisartans antagonistiske effekt på angiotensin II (AT1)-receptorerne.
English: EU/1/02/215/006 14 tablets EU/1/02/215/007 28 tablets EU/1/02/215/008 28 x 1 tablets EU/1/02/215/014 30 tablets EU/1/02/215/009 56 tablets EU/1/02/215/012 90 tablets EU/1/02/215/010 98 tablets
Danish: EU/1/02/215/006 14 tabletter EU/1/02/215/007 28 tabletter EU/1/02/215/008 28 x 1 tabletter EU/1/02/215/014 30 tabletter EU/1/02/215/009 56 tabletter EU/1/02/215/012 90 tabletter EU/1/02/215/010 98 tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder 80 mg telmisartan og 25 mg hydrochlorthiazid.
English: Because no information is available regarding the use of PritorPlus during breast-feeding, PritorPlus is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Som alternativ anbefales behandlingsregimer med bedre etablerede sikkerhedsprofiler ved amning, specielt ved amning af nyfødte og præmature spædbørn.
English: Each 40 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 169 mg sorbitol (E420).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Én 40 mg/12,5 mg tablet indeholder 112 mg lactosemonohydrat og 169 mg sorbitol (E420).
English: Pack sizes: - Blister with 14, 28, 30, 56, 90, or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets.
Danish: Pakningsstørrelse: - Blister med 14, 28, 30, 56, 90, eller 98 tabletter eller - Perforeret enkeltdosis blister med 28 x 1 tabletter.
English: PritorPlus 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Danish: PritorPlus 40 mg/12,5 mg tabletter Én tablet indeholder 40 mg telmisartan og 12,5 mg hydrochlorthiazid.
English: PritorPlus 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Danish: PritorPlus 80 mg/12,5 mg tabletter Én tablet indeholder 80 mg telmisartan og 12,5 mg hydrochlorthiazid.
English: PritorPlus fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on PritorPlus 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or adults who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Danish: • I fastdosiskombinationen er PritorPlus (80 mg telmisartan/25 mg hydrochlorthiazid) indiceret til voksne, hvis blodtryk ikke kan reguleres tilfredsstillende med PritorPlus 80 mg/12,5 mg (80 mg telmisartan/12,5 mg hydrochlorothiazid) eller til patienter, som tidligere er stabiliseret på telmisartan og hydrochlorothiazid givet hver for sig.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med PritorPlus Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: INFORMATION IN BRAILLE PritorPlus 80 mg/12.5 mg
Danish: INFORMATION I BRAILLESKRIFT PritorPlus 80 mg/12,5 mg
English: The overall incidence and pattern of adverse reactions reported with PritorPlus 80 mg/25 mg was comparable with PritorPlus 80 mg/12.5 mg. A dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Danish: Den totale incidens og mønster af bivirkninger rapporteret ved brug af PritorPlus 80 mg/25 mg var sammenlignelig med PritorPlus 80 mg/12,5 mg.
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in PritorPlus, minimal or no effects were reported.
Danish: Der er dog kun rapporteret om minimal eller ingen påvirkning ved den mængde thiazid (12,5 mg), som findes i PritorPlus.
English: Due to the hydrochlorothiazide component, markedly low blood pressure and low blood levels of potassium can also happen, which may result in nausea, sleepiness and muscle cramps and/or irregular heartbeat associated with the concomitant use of drugs such as digitalis or certain anti-arrhythmic treatments.
Danish: På grund af hydrochlorthiazid, kan markant lavt blodtryk og lavt indhold af kalium i blodet også forekomme, hvilket kan resultere i kvalme, søvnighed og muskelkramper.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known:
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: The use of PritorPlus during breast feeding is not recommended.
Danish: Det frarådes at anvende PritorPlus i ammeperioden.
English: Telmisartan is not removed by haemodialysis.
Danish: Behandling: Telmisartan fjernes ikke ved hæmodialyse.
English: MARKETING AUTHORISATION HOLDER Bayer AG
Danish: Indehaver af markedsføringstilladelse Bayer AG
English: Infections and infestations Rare:
Danish: Infektioner og parasitære sygdomme Ikke almindelig:
English: PritorPlus 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Danish: PritorPlus 80 mg/12,5 mg tabletten er rød og hvid, oval og er i 2 lag hvorpå koden ”H8” er præget.
English: Pack sizes: - Blister with 14, 28, 30, 56, 90 or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets
Danish: Blister med 14, 28, 30, 56, 90 eller 98 tabletter eller Perforeret enkeltdosis blister med 28 x 1 tabletter
English: PritorPlus 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Danish: PritorPlus 80 mg/25 mg tabletten er gul og hvid, oval og er i 2 lag hvorpå firmaets logo og koden ”H9” er præget.
English: Nausea
Danish: Rastløshed
English: PritorPlus 40 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 5.2 mm engraved with the code number 'H4'.
Danish: PritorPlus 40 mg/12,5 mg tabletter Ovale 5,2 mm aflange tabletter i to lag, et rødt og et hvidt, hvori koden ”H4” er præget på.
English: PritorPlus 40 mg/12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number 'H4'.
Danish: PritorPlus 40 mg/12,5 mg tabletten er rød og hvid, oval og er i 2 lag hvorpå koden ”H4” er præget.
English: PritorPlus 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Danish: PritorPlus 80 mg/25 mg tabletter telmisartan/hydrochlorthiazid
English: PritorPlus 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: PritorPlus 40 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: Periodic monitoring of serum potassium and ECG is recommended when PritorPlus is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Danish: Når PritorPlus anvendes sammen med lægemidler, hvis effekt påvirkes af serumkaliumforstyrrelser (såsom digitalisglykosider, antiarytmika), bør serumkalium og ekg monitoreres.
English: Eczema, drug eruption, toxic skin eruption Musculoskeletal, connective tissue and bone disorders Rare:
Danish: Knogler, led, muskler og bindevæv Sjælden:
English: NAME OF THE MEDICINAL PRODUCT PritorPlus 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN PritorPlus 40 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: NAME OF THE MEDICINAL PRODUCT PritorPlus 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN PritorPlus 80 mg/25 mg tabletter telmisartan/hydrochlorthiazid
English: PritorPlus 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: PritorPlus 80 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: toxic epidermal necrolysis, erythema multiforme Musculoskeletal, connective tissue and bone disorders Not known:
Danish: Knogler, led, muskler og bindevæv Ikke kendt:
English: NAME OF THE MEDICINAL PRODUCT PritorPlus 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: LÆGEMIDLETS NAVN PritorPlus 80 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: - Gout.
Danish: (Se pkt.
English: PritorPlus is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Danish: Din læge vil vælge en anden behandling til dig, hvis du ønsker at amme.
English: NAME OF THE MEDICINAL PRODUCT PritorPlus 40 mg/12.5 mg tablets
Danish: PritorPlus 40 mg/12,5 mg tabletter PritorPlus 80 mg/12,5 mg tabletter
English: 160 µg / 4.5 µg Inhalation powder Inhalation use inhaler
Danish: 160 µg / 4.5 µg Inhalationspulver Til inhalation inhalator
English: Inhalation powder Inhalation use inhaler
Danish: Inhalationspulver Til inhalation inhalator
English: MA (EU) Number
Danish: EU-nummer
English: Alternatives should be considered, particularly for long-term use.
Danish: Alternativer skal overvejes, især til langsigtet anvendelse.
English: *based on historic controls.
Danish: *Baseret på historiske kontroller.
English: Where possible, alternatives such as azithromycin should be considered.
Danish: Hvor det er muligt, skal alternativer som azithromycin overvejes.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk observeret inden for de første få uger eller måneder efter indledning af cART.
English: A protein-rich nutritional drink alone does not replace a meal.
Danish: En proteinrig ernæringsdrik alene kan ikke erstatte et måltid.
English: African-America/African Heritage/Other Age (years)
Danish: Afroamerikansk/afrikansk oprindelse/andre Alder (år)
English: • Do not chew, crush or split the tablet, to ensure the full dose is taken.
Danish: • Du må ikke tygge, knuse eller dele tabletten, for at sikre at den fulde dosis er indtaget.
English: A meal is important to get the right levels of medicine in your body.
Danish: Måltidet er vigtigt, for at du kan få det rette niveau af medicinen i kroppen.
English: → Don't drive or operate machinery unless you are sure you're not affected.
Danish:  Du må ikke føre motorkøretøj eller betjene maskiner, medmindre du er sikker på, at du ikke er påvirket.
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body.
Danish: • svækkelse, der begynder i hænder og fødder og bevæger sig op mod selve kroppen.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them, so it is very important to talk to your doctor about any changes in your health.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger, derfor er det meget vigtigt, at du fortæller lægen om enhver ændring i dit helbred.
English: This medicine is not for use in children or adolescents less than 18 years of age, because it has not been studied in these patients.
Danish: Dette lægemiddel må ikke anvendes til børn eller unge under 18 år, da det ikke er undersøgt hos disse patienter.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Danish: De almindeligste mutationer var de samme i analyserne fra uge 48 og uge 96.
English: The clinical implications of this finding are currently unknown.
Danish: De kliniske implikationer af dette fund er på nuværende tidspunkt ukendte.
English: N = Number of subjects in each treatment arm
Danish: N = Antal personer i hver behandlingsgruppe
English: ATC code: J05AR21
Danish: ATC-kode: J05AR21
English: There are limited data available on the use of Juluca in patients aged 65 years and over.
Danish: Der er begrænsede data om anvendelse af Juluca hos patienter på 65 år og derover.
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Danish: Symptomer på autoimmune sygdomme kan udvikle sig mange måneder efter, at du er begyndt at tage medicin til behandling af din hiv-infektion.
English: Adjusted difference (95% CI) -0.6 (-1.7, 0.6).
Danish: Justeret difference (CI 95 %) -0,6 (-1,7, 0,6).
English: Effect of human serum and serum proteins
Danish: Virkning af humant serum og serumproteiner
English: The frequency category of rare was estimated based on postmarketing reports.
Danish: Hyppighedskategorien sjælden blev vurderet på basis af rapporter efter markedsføringen.
English: • difficulty in sleeping (insomnia).
Danish: • problemer med at sove (insomni).
English: Then take the next dose as usual.
Danish: Tag derefter den næste dosis på det sædvanlige tidspunkt.
English: Juluca keeps the amount of HIV virus in your body at a low level.
Danish: Juluca holder mængden af hiv virus i kroppen på et lavt niveau.
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Danish: Kun H2-receptorantagonister, der kan administreres en gang dagligt, må anvendes.
English: Any beneficial effect on fracture rate was not studied.
Danish: En eventuel gavnlig virkning på frakturraten blev ikke undersøgt.
English: • allergic (hypersensitivity) reaction (see ‘allergic reactions' earlier in this section)
Danish: • allergisk reaktion (overfølsomhedsreaktion) (se 'allergiske reaktioner' tidligere under dette punkt)
English: • if they are overweight.
Danish: • hvis man er overvægtig
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Danish: Men klinisk overvågning anbefales, da vedligeholdelsesbehandling med methadon muligvis skal justeres hos nogle patienter.
English: It is recommended that the filmcoated tablet be swallowed whole with water and not be chewed or crushed.
Danish: Det anbefales, at den filmovertrukne tablet sluges hel med vand og ikke tygges eller knuses.
English: Juluca may replace your current antiretroviral medicines.
Danish: Juluca skal muligvis erstatte dine nuværende antiretrovirale lægemidler.
English: This is an uncommon (may affect up to 1 in 100 people) reaction in people taking dolutegravir.
Danish: Dette er en ikke almindelig reaktion (kan forekomme hos op til 1 ud af 100 personer) hos personer, der tager dolutegravir.
English: →Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: While 24 infants were confirmed to be uninfected, 5 were indeterminate due to incomplete testing, see sections 4.2, 4.4 and 5.2.
Danish: Mens 24 spædbørn blev bekræftet at være uinficerede, var 5 uvisse på grund af utilstrækkelig testning, se afsnit 4.2, 4.4 og 5.2.
English: • increase in cholesterol
Danish: • stigning i cholesterol
English: Clinical safety data with Juluca is limited.
Danish: Kliniske sikkerhedsdata om Juluca er begrænsede.
English: Therefore, information regarding drug-drug interactions with other antiretroviral medicinal products is not provided.
Danish: Derfor er oplysninger om lægemiddelinteraktioner med andre antiretrovirale lægemidler ikke angivet.