FrancophonIA/ELRC3.0 huggingface dataset:
English: • Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Danish: Almindelig (forekommer hos op til 1 ud af 10 patienter): - Svært nedsat nyrefunktion (vil normalt blive afgjort af din læge ved hjælp af en speciel type blodprøver).
English: Instructions for preparing reduced doses of Zoledronic Acid Accord: Withdraw the appropriate volume of the liquid concentrate, as follows: o 4.4 ml for 3.5 mg dose o 4.1 ml for 3.3 mg dose o 3.8 ml for 3.0 mg dose
Danish: Instruktion for tilberedning af reducerede doser af Zoledronsyre Accord: Udtag det passende volumen af det flydende koncentrat som følger: 4,4 ml til 3,5 mg dosis
English: How to prepare and administer Zoledronic Acid Accord
Danish: Tilberedelse og indgift af Zoledronsyre Accord
English: What Zoledronic Acid Accord looks like and contents of the pack Zoledronic Acid Accord is supplied as a liquid concentrate in a vial.
Danish: Hvordan får du Zoledronsyre Accord - Zoledronsyre Accord gives som drop (infusion) i en vene.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Zoledronsyre Accord 4 mg/5 ml koncentrat til infusionsvæske, opløsning
English: Uncommon ( 1/1.000 to < 1/100)
Danish: Ikke almindelig ( 1/1.000 til < 1/100)
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Danish: For at undgå eventuelle uforligeligheder skal der enten bruges 0,9 % w/v natriumchlorid- eller 5 % w/v glucoseinfusionsvæske til fortynding.
English: • The usual single dose given is 4 mg zoledronic acid.
Danish: Hvor meget Zoledronsyre Accord skal du have - Den normale enkeltdosis er 4 mg zoledronsyre.
English: How Zoledronic Acid Accord is given
Danish: Hvordan skal Zoledronsyre Accord opbevares
English: - Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6)
Danish: Overfølsomhed over for det aktive stof, andre bisfosfonater eller over for et eller flere af hjælpestofferne anført i pkt.
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid .
Danish: Derudover har der været sporadiske rapporter om osteonekrose af andre steder, inklusive hoften og femur.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Danish: strålebehandling eller operation af knogler, eller tumorinduceret hyperkalcæmi) hos voksne patienter med fremskreden malign sygdom og knoglemetastaser.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given Zoledronic Acid Accord
Danish: Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, før du bruger Zoledronsyre Accord: hvis du har eller har haft en nyrelidelse.
English: Musculoskeletal and connective tissue disorders
Danish: Muskel- og knoglesmerter
English: • As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Danish: Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Som følge af lave calcium-værdier: kramper, følelsesløshed og tetani (sekundære symptomer på hypokalcæmi).
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Danish: Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypokalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom.
English: Zoledronic Acid Accord 4 mg concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Danish: Zoledronsyre Accord 4 mg koncentrat til infusionsvæske, opløsning, fortyndet yderligere i 100 ml (se pkt.
English: you will be given one infusion of Zoledronic Acid Accord every three to four weeks.
Danish: Hvor ofte skal du have Zoledronsyre Accord - Hvis du er i forebyggende behandling for knoglekomplikationer pga. knoglemetastaser, vil du få en infusion af Zoledronsyre Accord hver tredje til fjerde uge.
English: • Keep Zoledronic Acid Accord out of the reach and sight of children.
Danish: - Zoledronsyre Accord opbevares utilgængeligt for børn.
English: Do not receive Zoledronic Acid Accord:
Danish: Du må ikke få Zoledronsyre Accord: hvis du ammer.
English: somnolence
Danish: Amning
English: • Chest pain.
Danish: Amning (se pkt.
English: • Increased sweating.
Danish: - Vægtøgning - Øget svedtendens Søvnighed.
English: Mannitol (E421) Sodium citrate Water for injections
Danish: Mannitol (E421)
English: How Zoledronic Acid Accord is used
Danish: Sådan skal du bruge Zoledronsyre Accord
English: Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment.”
Danish: Størstedelen af den antihypertensive effekt opnås som regel senest 4 uger efter behandlingsstart."
English: • Other contraindications
Danish: • Andre kontraindikationer
English: The symptomatic manifestations of overdose and recommendations on management if it occurs were included in this section.
Danish: De symptomatiske manifestationer af overdosis og anbefalinger om håndtering, hvis det forekommer, blev medtaget i dette punkt.
English: Overall summary of the scientific evaluation of Atacand Plus and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Atacand Plus og tilknyttede navne (se bilag I)
English: The information on administration of candesartan/HCT with or without food be located previously in section 4.5 was moved to section 4.2.
Danish: Oplysningerne om administration af candesartan/HCT med eller uden mad, der tidligere var placeret i punkt 4.5, er blevet flyttet til punkt 4.2.
English: The CHMP considered the following strengths for Atacand Plus tablets indicated for oral use: 8/12.5 mg, 16/12.5 mg, 32/12.5 mg, and 32/25 mg.
Danish: CHMP vurderede følgende styrker for Atacand Plus tabletter til oral anvendelse: 8/12,5 mg, 16/12,5 mg, 32/12,5 mg og 32/25 mg.
English: The brief general safety information from clinical studies on doses up to 16/12.5 mg, including withdrawal figures was the same in most countries.
Danish: De korte generelle sikkerhedsoplysninger fra kliniske undersøgelser af doser op til 16/12,5 mg, herunder tilbageholdelsestal, var ens i de fleste lande.
English: An additional sentence was introduced by CHMP to stress the preferable practice to titrate with separate components.
Danish: CHMP har tilføjet en sætning for at understrege den foretrukne praksis med at titrere med separate komponenter.
English: Information on effects on ability to drive and use machines was included in all countries with slightly different wording in one SPCs.
Danish: Oplysninger om virkningen på evnen til at føre motorkøretøj eller betjene maskiner blev inkluderet i alle lande med en lidt anderledes ordlyd i et enkelt produktresumé.
English: Hydroclorthiazide is a diuretic, reduces the volume of the blood, helping control the blood pressure.
Danish: Hydrochlortiazid er et diuretikum, som reducerer blodvolumen, hvilket er med til at kontrollere blodtrykket.
English: The sentence on the clinical significant interactions was corrected in line with the previous Atacand harmonisation referral.
Danish: Sætningen om de klinisk signifikante interaktioner blev korrigeret i henhold til den tidligere indbringelse med henblik på harmonisering vedrørende Atacand.
English: Other sections of the SPC were harmonised accordingly.
Danish: Andre punkter i produktresuméet blev harmoniseret i overensstemmelse hermed.
English: The CHMP endorsed the proposed harmonised wording: “The recommended dose of Atacand Plus is one tablet once daily.
Danish: CHMP godkendte den foreslåede, harmoniserede formulering: "Den anbefalede dosis for Atacand Plus er én tablet én gang om dagen.
English: Section 5.1 Pharmacodynamic Properties
Danish: Punkt 5.1 Farmakodynamiske egenskaber
English: Withdrawals from treatment due to adverse events were similar with candesartan cilexetil/hydrochlorothiazide (2.3 - 3.3%) and placebo (2.7 - 4.3%)”.
Danish: Tallene for udtræden af behandling på grund af bivirkninger lignede tallene for candesartan cilexetil/hydrochlorthiazid (2,3-3,3 %) og placebo (2,7-4,3 %)".
English: This section was shortened and harmonised taking into account the current scientific knowledge and in line with the discussions for other sections of the SPC.
Danish: Punktet blev forkortet og harmoniseret under hensyntagen til den eksisterende faglige viden og i overensstemmelse med drøftelserne af andre punkter i produktresuméet.
English: In line with the SPC Guideline (2009), two MSs included “Treatment of” followed by the indication.
Danish: I overensstemmelse med vejledningen vedrørende produktresuméer (2009) inkluderede to medlemsstater "Behandling af" efterfulgt af indikationen.
English: This section was updated in accordance with the SPC Guideline (2009), including all ADRs listed in most countries, as the harmonised text.
Danish: Dette punkt blev opdateret i overensstemmelse med vejledningen vedrørende produktresuméer (2009), herunder alle bivirkninger angivet i de fleste lande, som den harmoniserede tekst.
English: Package leaflet and labelling
Danish: Indlægsseddel og etikettering
English: Candesartan cilexetil is an angiotensin receptor blocker (ARB).
Danish: Candesartan cilexetil er en angiotensinreceptorblokker (ARB).
English: This wording was considered in the proposed harmonised SPC.
Danish: Denne ordlyd blev taget i betragtning i det forslåede, harmoniserede produktresumé.
English: All countries' SPCs for candesartan/HCT 16/12.5 mg or higher strengths included a recommendation on dose titration of candesartan before switching to the fixed dose combination.
Danish: Alle landes produktresuméer for candesartan/HCT 16/12,5 mg eller højere styrker omfattede en anbefaling af dosistitrering for candesartan, inden man går over til fastdosiskombinationen.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet presented by the European Medicines Agency
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: However, the CHMP/PhVWP report on the use of ACE inhibitors and angiotensin II receptor antagonists (ARBs) during the 1st trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007) indicates that a contraindication during the first trimester of pregnancy is not justified; the use of AIIRAs in the first trimester of pregnancy is not recommended.
Danish: CHMP/PhVWP's rapport om brug af ACE-hæmmere og angiotensin II-receptorantagonister (AIIRA'er) i graviditetens første trimester (EMEA/CHMP/PhVWP/474692/2007) tyder imidlertid på, at en kontraindikation i graviditetens første trimester ikke er begrundet.
English: These subheadings in this section of the SPCs were revised in accordance with the SPC Guideline (2009).
Danish: Disse underpunkter blev revideret i dette punkt af produktresuméerne i henhold til vejledningen vedrørende produktresuméer (2009).
English: Atacand Plus may be administered in patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy or Atacand Plus at lower doses.
Danish: Atacand Plus kan gives til patienter, hvis blodtryk ikke kan kontrolleres optimalt ved hjælp af candesartan cilexetil eller hydrochlorthiazid monoterapi eller Atacand Plus i lavere doser.
English: Furthermore, hydrochlorothiazide was omitted, as Atacand Plus contains hydrochlorothiazide.
Danish: Hydrochlorthiazid blev desuden udeladt, eftersom Atacand Plus indeholder hydrochlorthiazid.
English: • Pregnancy and lactation
Danish: • Fertilitet, graviditet og amning
English: In particular, updates on clinical efficacy in elderly hypertensive patients, where results from a trial in elderly patients were included, the pharmacodynamic effects of HCT, and the clinical efficacy of candesartan/HCT in hypertensive patients were considered.
Danish: Der blev navnlig taget højde for opdateringer om klinisk effekt hos ældre hypertensive patienter, hvor resultater fra en undersøgelse af ældre patienter blev inddraget, HTC's farmakodynamiske virkning og den kliniske effekt af candesartan/HCT hos hypertensive patienter.
English: When clinically appropriate a direct change from monotherapy to Atacand Plus may be considered.
Danish: Når det skønnes klinisk påkrævet, kan et direkte skift fra monoterapi til Atacand Plus overvejes.
English: Based on the information provided, the CHMP endorsed the harmonised text for the AIIRA as the standard warning elaborated by the CHMP's PhVWP for all AIIRA: the use of AIIRAs in the first trimester of pregnancy is not recommended; the use of AIIRAs in the second and third trimester is contraindicated.
Danish: På grundlag af de fremlagte oplysninger har CHMP godkendt den harmoniserede tekst til AIIRA'erne som standardadvarsel uddybet af CHMP's arbejdsgruppe vedrørende lægemiddelovervågning for alle AIIRA'er: Brug af AIIRA'er anbefales ikke under graviditetens første trimester; brug af AIIRA'er er kontraindiceret under graviditetens andet og tredje trimester.
English: Based on the above, the CHMP considers the benefit risk ratio of Atacand Plus to be favourable and the harmonised PI to be appropriate.
Danish: På baggrund af ovenstående anser CHMP benefit/risk-forholdet for Atacand Plus for positivt og de harmoniserede produktinformationsdokumenter for at være passende.
English: The CHMP considered that the benefit/risk balance of candesartan cilexetil/hydrochlorothiazide is positive for the below mentioned indication and the proposed wording was supported and in line with current SPC guideline: “Treatment of essential hypertension, in adult patients whose blood pressure is not optimally controlled with candesartan cilexetil or hydrochlorothiazide monotherapy”.
Danish: CMPH vurderede, at benefit/risk-forholdet for candesartan cilexetil/hydrochlorthiazid for den nedenfor anførte indikation er positivt, og at den foreslåede ordlyd var understøttet og i overensstemmelse med den nuværende vejledning vedrørende produktresuméer: "Behandling af essentiel hypertension hos voksne patienter, hvis blodtryk ikke kan kontrolleres optimalt ved hjælp af candesartan cilexetil eller hydrochlorthiazid monoterapi".
English: Section 4.6 Pregnancy and Lactation
Danish: Punkt 4.6 Fertilitet, graviditet og amning
English: In particular, regarding interactions with potassium sparing diuretics, or other medicinal products that may increase serum potassium levels, other medicinal products that induce torsades de pointes, NSAIDS, colestipol or cholestyramine, nondepolarising skeletal muscle relaxants, calcium supplements or vitamin D, betablockers and diazoxide, anticholinergic agents, amantadine, cytotoxic medicinal products, alcohol intake, barbiturates, anaesthetics, antidiabetic medicinal products, pressor amines, iodinated contrast media and cyclosporine, among others.
Danish: Navnlig for så vidt angår interaktioner med blandt andet kaliumbesparende diuretika eller andre lægemidler, som kan øge indholdet af kalium i blodet, andre lægemidler, som forårsager torsades de pointes, NSAID-præparater, kolestipol eller kolestyramin, ikke-depolariserende muskelafslappende lægemidler, kalciumtilskud eller D-vitamin, betablokkere og diazoxid, antikolinerge stoffer, amantadin, cytotoksiske lægemidler, alkoholindtagelse, barbiturater, anæstetika, antidiabetiske lægemidler, sammentrækkende aminer, jodholdige kontraststoffer og cyclosporin.
English: The sections on use in the elderly, patients with intravascular volume depletion, patients with renal impairment, patients with hepatic impairment and paediatric population were also harmonised.
Danish: Punkterne om brug til ældre, patienter med intravaskulær volumendepletering, patienter med nyre- og leverinsufficiens og den pædiatriske population blev også harmoniseret.
English: The CHMP endorsed this updated information proposed by the MAH as harmonised text: “In controlled clinical studies with candesartan cilexetil/hydrochlorothiazide adverse reactions were mild and transient.
Danish: CHMP godkendte de opdaterede oplysninger fra indehaveren af markedsføringstilladelsen som en harmoniseret tekst: "I kontrollerede kliniske undersøgelser med candesartan cilexetil/hydrochlorthiazid var bivirkningerne milde og forbigående.
English: The CHMP endorsed the harmonised text finding the proposed wording acceptable and in line with that of other ARB or antihypertensive SPCs.
Danish: CHMP godkendte den harmoniserede tekst og finder den foreslåede ordlyd acceptabel og i overensstemmelse med ordlyden i produktresuméer til andre ARB-præparater eller lægemidler mod hypertension.
English: The approved mutual recognition wording stated “Essential hypertension, where monotherapy with candesartan cilexetil or hydrochlorothiazide is not sufficient.” There were some differences in Member States (MSs') summary of product characteristics' (SPCs) in the approved indication: most countries stated ‘Essential hypertension', one mentioned the word ‘arterial' (which was omitted in the final proposal), and one included the word ‘adult' (which was considered in the final proposal).
Danish: Der var visse forskelle i medlemsstaternes produktresuméer for den godkendte indikation: De fleste lande angav "essentiel hypertension", et land nævnte ordet "arteriel" (som blev udeladt i det endelige forslag), og et andet land ordet "voksen" (hvilket blev taget i betragtning i det endelige forslag).
English: In particular, the indication and its associated posology recommendation, the contraindications and the pregnancy and lactation sections were harmonised.
Danish: Særligt blev indikationen og dens tilhørende dosisanbefaling, kontraindikationerne og punkterne om fertilitet, graviditet og amning harmoniseret.
English: The CHMP also agreed with the inclusion of a contraindication in patients with hypersensitivity to the active substances or to any of the excipients, severe renal and hepatic impairment and/or cholestasis, refractory hypokalaemia and hypercalcaemia, and gout.
Danish: CHMP var også enige i medtagelsen af en kontraindikation for patienter med overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne og patienter med svær lever- og nyreinsufficiens og/eller cholestase, refraktær hypokaliæmi og hypercalcæmi samt urinsyregigt.
English: Dose titration with the individual components (candesartan cilexetil and hydrochlorothiazide) is recommended.
Danish: Dosistitrering med de individuelle komponenter (candesartan cilexetil og hydrochlorthiazid) anbefales.
English: Atacand Plus contains candesartan cilexetil and hydrochlorothiazide (HCT).
Danish: Atacand Plus indeholder candesartan cilexetil og hydrochlorthiazid (HTC).
English: Posology
Danish: Dosering
English: Warnings regarding renal impairment, kidney transplantation pregnancy, renal artery stenosis, intravascular volume depletion, anaesthesia and surgery, hepatic impairment, aortic and mitral valve stenosis, primary hyperaldosteronism, electrolyte imbalance, metabolic and endocrine effects, photosensitivity, pregnancy and others were harmonised.
Danish: Advarsler vedrørende nyreinsufficiens, nyretransplantation, nyrearteriestenose, intravaskulær volumendepletering, anæstesi og operation, leverinsufficiens, aorta- og mitralklapstenose, primær hyperaldosteronisme, elektrolytforstyrrelse, stofskifte- og hormonforstyrrende effekter, lysfølsomhed, graviditet m.m. blev harmoniseret.
English: In conclusion, based on the assessment of the MAH proposal and responses, and following the discussions of the committee, the CHMP adopted the harmonised set of PI for Atacand Plus and associated names.
Danish: CHMP vedtog således, baseret på bedømmelsen af forslag og svar fra indehaveren af markedsføringstilladelsen og efter drøftelser i udvalget, at harmonisere produktinformationsdokumenterne for Atacand Plus og relaterede navne.
English: Section 4.8 Undesirable Effects
Danish: Punkt 4.8 Bivirkninger
English: Dose titration of candesartan cilexetil is recommended when switching from hydrochlorothiazide monotherapy.
Danish: Dosistitrering af candesartan cilexetil anbefales ved skift fra hydrochlorthiazid monoterapi.
English: The changes to the SPC were taken into account in the amendments to the PL and labelling as appropriate.
Danish: Ændringerne i indlægssedlen og etiketteringen tager højde for relevante ændringer i produktresuméet.
English: A full contraindication in pregnancy and during lactation was previously included in most SPCs.
Danish: Produktresuméet indeholdt tidligere en fuld kontraindikation under graviditet og ved amning.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Atacand Plus and associated names (see Annex I).
Danish: • produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse,
English: Cough was added as a very rare ADR to section 4.8 of the SPC, as a result of the PSUR evaluation for candesartan/HCT.
Danish: Efter evalueringen af den periodiske sikkerhedsopdatering for candesartan/HCT blev hoste tilføjet produktresuméets punkt 4.8 som en meget sjælden bivirkning.
English: Based on the information available in the MS'sSPC, this section was updated.
Danish: Dette punkt blev opdateret på baggrund af oplysningerne i medlemsstaternes produktresuméer.
English: Adopted at the 11-14 June 2019 PRAC
Danish: Vedtaget på PRAC's møde den 11.-14. juni 2019
English: Frequency not known: uveitis
Danish: Hyppighed ikke kendt: uveitis
English: Please see Section 4.4 “Interference with laboratory testing”.
Danish: Se punkt 4.4 "Interferens med laboratorieprøver".
English: Possible side effects Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 patienter):
English: Interference with laboratory testing
Danish: Interferens med laboratorieprøver
English: You may need treatment with [Product name] during pregnancy if the potential benefit outweighs the potential risk to you and your unborn baby.
Danish: Du kan måske have behov for at blive behandlet med [produktnavn] under graviditeten, hvis den mulige fordel opvejer den mulige risiko for dig og dit ufødte barn.
English: Propylthiouracil is able to cross the human placenta.
Danish: Propylthiouracil kan krydse den humane placenta.
English: Caution should be exercised in the interpretation of these laboratory results in patients who are receiving sulfasalazine.
Danish: Der bør udvises forsigtighed ved fortolkningen af sådanne laboratorieresultater hos patienter, der får sulfasalazin.
English: […] Overdose can unmask existing Brugada syndrome.
Danish: […] Overdosering kan demaskere eksisterende Brugadas syndrom.
English: Epidemiological studies provide conflicting results regarding the risk of congenital malformations.
Danish: Epidemiologiske studier viser modstridende resultater, hvad angår risikoen for medfødte misdannelser.