FrancophonIA/ELRC3.0 huggingface dataset:
English: - The Committee concluded that the Product Information of all Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) should include information to the amended indication on the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristic and Package Leaflet accordingly.
Danish: - CHMP konkluderede, at produktoplysningerne for alle Valproate-ratiopharm chrono 300/500 mg Retardtabletten (og tilknyttede navne) skulle indeholde oplysninger om den ændrede indikation til behandling af mani ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres, og derfor anbefalede CHMP tilsvarende ændringer af de pågældende punkter i produktresuméet og indlægssedlen.
English: The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.”
Danish: Fortsættelse af behandling efter en manisk episode kan overvejes hos patienter, som har responderet på valproat ved akut mani."
English: The daily dose should be adapted individually to the clinical response to establish the lowest effective dose for of the individual patient.
Danish: Den daglige dosis skal tilpasses individuelt til den kliniske respons for at fastlægge den laveste, effektive dosis til af den enkelte patient.
English: Furthermore, when the proposed indication is granted the MAHs should submit a Risk Management Plan to the NCAs for assessment.
Danish: Endvidere skulle indehaverne af markedsføringstilladelsen fremlægge en risikostyringsplan for de nationale kompetente myndigheder til vurdering, når den foreslåede indikation var blevet godkendt.
English: In the two-arm study performed by Calabrese and co-workers (2005) patients in the valproate group performed better in several efficacy parameters compared to the lithium group (in a statistically nonsignificant way), however significantly more patients in the lithium group experienced various adverse effects (tremor, polyuria, polydipsia) compared to the valproate group.
Danish: I den toarmede undersøgelse, der blev foretaget af Calabrese og medarbejdere (2005), klarede patienterne i valproatgruppen sig bedre for så vidt angik adskillige virkningsparametre sammenlignet med lithiumgruppen (på en statistisk ikke-signifikant måde).
English: <Valproinsäure-ratiopharm chrono 300 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (3 ½ and 6 ½ tablets).
Danish: <[HANDELSNAVN] 300 DEPOTTABLETTER > De anbefalede daglige doser er normalt på mellem 1.000 og 2.000 mg (3 ½ og 6 ½ tabletter).
English: Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Danish: Gennemsnitlig daglig dosis De anbefalede daglige doser er normalt på mellem 1.000 mg og 2.000 mg.
English: Valproinsäure Ratiopharm Chrono
Danish: Valpro ratiopharm Chrono
English: The continuation of treatment after manic episode could be considered in patients who have responded to the medicinal product for acute mania.
Danish: Fortsættelse af behandling efter en manisk episode kan overvejes hos patienter, som har responderet på lægemidlet for akut mani.
English: Children and adolescents under 18 years of age: {Invented name} should not be used in children and adolescents under 18 years of age for the treatment of mania.
Danish: Børn og unge under 18 år: {(Sær)navn} bør ikke bruges til behandling af mani hos børn og unge under 18 år.
English: It could be critisised that the latter study was not placebo-controlled; however the use of lithium in bipolar disorder, especially in the recurrence prevention is the established standard of care.
Danish: Brugen af lithium ved bipolær lidelse, navnlig til forebyggelse af tilbagevenden, er dog den etablerede behandlingsstandard.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALPROATERATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN (se bilag I)
English: - The Committee considered all the available data submitted on efficacy and the safety for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names), in relation to the treatment of mania in bipolar disorder as well in the prevention of recurrence of mood episodes.
Danish: - CHMP behandlede alle de foreliggende data, der var indsendt om virkning og sikkerhed for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (og tilknyttede navne)ved behandling af mani i forbindelse med bipolær lidelse og ved forebyggelse af humørsvingningsepisoders tilbagevenden.
English: Summary of Product Characteristics and Package Leaflet.
Danish: Produktresumé og indlægsseddel.
English: Valprotek CR 500 mg (prolonged release) tablets 500 mg
Danish: Valprotek CR 500 mg (prolonged release) tablets
English: To support the bipolar indication the MAHs submitted several published studies.
Danish: Indehaverne af markedsføringstilladelsen fremlagde resultaterne af adskillige offentliggjorte undersøgelser til støtte for den bipolære indikation.
English: <Valproinsäure-ratiopharm chrono 500 Retardtabletten> The recommended daily doses usually range between 1000 mg and 2000 mg (2 and 4 tablets).
Danish: <[HANDELSNAVN] 500 DEPOTTABLETTER > De anbefalede daglige doser er normalt på mellem 1.000 og 2.000 mg (2 og 4 tabletter).
English: Valprotek CR 300 mg (prolonged release) tablets 300 mg
Danish: Valprotek CR 300 mg (prolonged release) tablets
English: Acido valproico E sodio Valproato Ratiopharm 300 mg
Danish: Acido valproico E sodio Valproato Ratiopharm
English: Seizures:
Danish: Krampeanfald:
English: Product Name
Danish: Navn
English: The continuation of treatment after manic episode could be considered in patients who have responded to <valproate> for acute mania.
Danish: Fortsættelse af behandling efter en manisk episode kan overvejes hos patienter, som har responderet på valproat ved akut mani.
English: Women of child-bearing potential have to use effective contraception.
Danish: Kvinder i den fertile alder skal anvende sikker antikonception.
English: Initial dose
Danish: Startdosis
English: Adverse Events
Danish: BIVIRKNINGER
English: Retardtabletten
Danish: INDLÆGSSEDDEL
English: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Danish: Slovakiet ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES
Danish: ÆNDRINGER, DER SKAL INKLUDERES I DE RELEVANTE PUNKTER I PRODUKTRESUMEET FOR [HANDELSNAVN] 300/500 MG DEPOTTABLETTER OG ASSOCIEREDE NAVNE
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF PACKAGE LEAFLET FOR VALPROATE-RATIOPHARM CHRONO 300/500 MG RETARDTABLETTEN AND ASSOCIATED NAMES
Danish: ÆNDRINGER, DER SKAL INKLUDERES I DE RELEVANTE PUNKTER I INDLÆGSSEDLEN FOR [HANDELSNAVN] 300/500 MG DEPOTTABLETTER OG ASSOCIEREDE NAVNE
English: Nausea, sedation, extrapyramidal disorders.
Danish: Kvalme, sløvhed, ekstrapyramidale forstyrrelser (meget langsamme ufrivilige, vridende bevægelser).
English: The Netherlands
Danish: Medlemsstat
English: Valproat-Ratiopharm Chrono 300 mg
Danish: Valproat-Ratiopharm Chrono 300 mg 300 mg
English: Valproat-Ratiopharm Chrono 500 mg
Danish: Valproat-Ratiopharm Chrono 500 mg 500 mg
English: Natriumvalproaat ratiopharm chrono 300 mg 300 mg
Danish: Natriumvalproaat ratiopharm chrono 300 mg
English: As a consequence,the CHMP has recommended the granting of the variation for which the Summary of Product Characteristics and Package Leaflet is set out in Annex III for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names (see Annex I).
Danish: Produktresumé og indlægsseddel for Valproate-ratiopharm chrono 300/500 mg Retardtabletten og tilknyttede navne (se bilag I) fremgår af bilag III.
English: Natriumvalproaat ratiopharm chrono 500 mg 500 mg
Danish: Natriumvalproaat ratiopharm chrono 500 mg
English: Breast feeding
Danish: PRODUKTRESUME
English: Valproinsäure-ratiopharm chrono 500 mg
Danish: Valproinsäure-ratiopharm chrono 500 mg Retardtabletten
English: * International units per ml of rabbit serum determined by haemolysis inhibition assay
Danish: * Internationale enheder pr. ml kaninserum fastsat ved hæmolyseinhibitionsanalyse
English: 500ml 1 bottle
Danish: 1 flaske 0 dage
English: Content Package size Withdrawal period
Danish: Indhold Paknings størrelse
English: 500ml 6 bottles
Danish: 6 flasker
English: Unopened bottle: 3 years
Danish: Uåbnet flaske: 3 år
English: Date of first authorisation: 15 April 2005 Date of latest renewal: 19 January 2015
Danish: Dato for første markedsføringstilladelse: 15. april 2005 Dato for seneste fornyelse: 19. januar 2015
English: Long-term safety data in this population cannot be established from this study.
Danish: Langtidssikkerhedsdata hos denne population kan ikke bestemmes fra dette studie.
English: Aclasta with food and drink
Danish: Brug af Aclasta sammen med mad og drikke
English: Aclasta may work for longer than one year, and your doctor will let you know if you need to be treated again.
Danish: Aclasta kan virke i mere end et år, og din læge vil fortælle dig, om du skal behandles igen.
English: There are no data available for children under 5 years of age.
Danish: Der foreligger ingen data for børn under 5 år.
English: The following information is intended for healthcare professionals only (see section 3):
Danish: Følgende oplysninger er tiltænkt sundhedspersonale (se afsnit 3):
English: • Key signs and symptoms of serious adverse reactions
Danish: • Væsentlige tegn og symptomer på alvorlige reaktioner
English: You may eat normally on the day you are treated with Aclasta.
Danish: Du kan spise normalt den dag, du får behandling med Aclasta.
English: Aclasta was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Danish: Aclasta blev administreret en gang årligt, indtil mindst 211 patienter i forsøgspopulationen havde bekræftede kliniske frakturer.
English: Uncommon Decreased appetite Rare
Danish: Ikke almindelig Nedsat appetit Sjælden
English: If you missed a dose of Aclasta Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Danish: Hvis du har glemt en dosis Aclasta Kontakt din læge eller dit hospital så hurtigt som muligt for at få en ny tid.
English: It is currently unclear whether Aclasta causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Aclasta.
Danish: Det er på nuværende tidspunkt uklart, om Aclasta forårsager denne uregelmæssige hjerterytme, men du skal kontakte din læge, hvis du oplever sådanne symptomer, efter du har fået Aclasta.
English: Currently available data for children aged 5 to 17 years are described in section 5.1.
Danish: De foreliggende data for børn i alderen 5-17 år er beskrevet i pkt.
English: You must not be given Aclasta if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Danish: Du må ikke få Aclasta, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat.
Danish: Det er vigtigt at prøve at undgå udvikling af osteonekrose i kæben, da det er en smertefuld lidelse, som kan være svær at behandle.
English: Frequency categories are 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); not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret ved brug af følgende konvention: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Your doctor, pharmacist or nurse knows how to store Aclasta properly.
Danish: Lægen, apoteket eller sygeplejersken ved, hvordan Aclasta skal opbevares korrekt.
English: Very common Pyrexia Common
Danish: Meget almindelig Pyreksi Almindelig
English: After opening: 24 hours at 2°C - 8°C
Danish: Efter åbning: 24 timer ved 2°C - 8°C
English: EXP After opening: 24 hours at 2°C - 8°C.
Danish: EXP Efter åbning: 24 timer ved 2°C - 8°C.
English: Aclasta may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Danish: Aclasta kan også give andre bivirkninger Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) Feber
English: Your doctor will advise you and decide how long you should be treated with Aclasta.
Danish: Din læge vil vejlede dig og beslutte, hvor længe du skal behandles med Aclasta.
English: Thus these results precluded determining a definitive effect of Aclasta on fertility in humans.
Danish: Derfor forhindrede disse resultater bestemmelse af Aclastas definitive effekt på fertilitet i mennesker.
English: The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Aclasta on an individual patient basis, particularly after 5 or more years of use.
Danish: Behovet for fortsat behandling skal revurderes regelmæssigt, baseret på fordele og mulige risici af Aclasta for den enkelte patient, især efter anvendelse i 5 år eller mere.
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på karton og flaske efter EXP. - Den uåbnede flaske kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months
Danish: Tabel 2 Resumé af effekt på vertebrale frakturer ved 12, 24 og 36 måneder
English: Aclasta should not be used in children and adolescents below 18 years of age.
Danish: Aclasta bør ikke anvendes til børn og unge under 18 år.
English: The recommended dose is a single intravenous infusion of 5 mg Aclasta.
Danish: Den anbefalede dosis er en enkelt intravenøs infusion af 5 mg Aclasta.
English: Uncommon Hypertension, flushing Not known** Hypotension (some of the patients had underlying risk factors)
Danish: Ikke almindelig Forhøjet blodtryk, rødmen Ikke kendt** Hypotension (nogle af patienterne havde underliggende risikofaktorer)
English: BOTTLE LABEL
Danish: FLASKENS ETIKET
English: If you are considering stopping Aclasta treatment, please go to your next appointment and discuss this with your doctor.
Danish: Hvis du overvejer at stoppe Aclasta-behandlingen, bedes du gå til din næste tid og drøfte det med lægen.
English: For osteoporosis, Aclasta works for one year.
Danish: For osteoporose virker Aclasta i 1 år.
English: Adverse reactions, such as dizziness, may affect the ability to drive or use machines.
Danish: Bivirkninger, såsom svimmelhed, kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
Danish: Incidensen af post-dosis-symptomer, der opstår inden for de første tre dage efter administration af Aclasta, kan reduceres ved at administrere paracetamol eller ibuprofen kort efter administration af Aclasta.
English: Aclasta must not be mixed or given intravenously with any other medicinal products.
Danish: Aclasta må ikke blandes eller gives intravenøst sammen med andre lægemidler.
English: The majority of these reactions occur within the first three days following Aclasta administration.
Danish: Størstedelen af disse bivirkninger opstår inden for de første tre dage efter administration af Aclasta.
English: You must not be given Aclasta: - if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Aclasta - hvis du er allergisk over for zoledronsyre, andre bisfosfonater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Other products containing zoledronic acid as an active substance are available for oncology indications.
Danish: Der er andre produkter tilgængelige, der indeholder zoledronsyre som aktivt indholdsstof, til onkologiske indikationer.
English: • Patients, especially elderly patients and those receiving diuretic therapy, should be appropriately hydrated prior to administration of Aclasta.
Danish: • Patienter, specielt ældre patienter og patienter i behandling med diuretika, bør være passende hydreret forud for behandling med Aclasta.
English: Measurement of serum calcium before infusion of Aclasta is recommended for patients with Paget´s disease.
Danish: Måling af serum calcium inden infusion med Aclasta er anbefalet hos patienter med Pagets sygdom.
English: Multipack: 5 bottles, each bottle of 100 ml.
Danish: Multipakning: 5 flasker, hver flaske indeholder 100 ml.
English: The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Aclasta.
Danish: Størstedelen af bivirkningerne, såsom feber og kulderystelser, smerter i muskler eller led og hovedpine, opstår inden for de første tre dage efter en dosis Aclasta.
English: • Need for adequate calcium and vitamin D supplementation, appropriate physical activity,
Danish: • Behovet for tilstrækkeligt indtag af calcium- og Vitamin D-tilskud, passende fysisk aktivitet,
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Danish: Dette er specielt vigtigt for patienter, der tager diuretika (”vandrivende”) og for ældre patienter (65 år eller derover).
English: Patients must be appropriately hydrated prior to administration of Aclasta.
Danish: Patienter skal være passende hydreret før administration af Aclasta.
English: There is no clear evidence establishing a link between BMD changes and fracture prevention in children with growing skeletons.
Danish: Der er ingen klar evidens for en sammenhæng mellem ændringer i BMD og forebyggelse af frakturer hos børn med skeletvækst.
English: In both women and men, Aclasta strengthens the bone and therefore makes it less likely to break.
Danish: Hos både mænd og kvinder styrker Aclasta knoglerne og mindsker derfor risikoen for brud.
English: In case you recently broke your hip, it is recommended that Aclasta is administered two or more weeks after your hip repair surgery.
Danish: Hvis du for nylig har brækket din hofte, anbefales det at Aclasta gives to eller flere uger efter din hofteoperation.
English: For the treatment of Paget's disease, Aclasta should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Danish: Til behandling af Pagets sygdom bør Aclasta kun ordineres af læger med erfaring i behandlingen af Pagets sygdom af knoglerne.
English: CARTON FOR INTERMEDIATE PACK (WITHOUT BLUE BOX)
Danish: KARTON FOR DEL-PAKNING (UDEN ”BLUE BOX”)
English: Driving and using machines If you feel dizzy while taking Aclasta, do not drive or use machines until you feel better.
Danish: Hvis du føler dig svimmel, mens du tager Aclasta, må du ikke køre bil eller betjene maskiner, før du har det bedre.
English: Aclasta demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Danish: Aclasta viste en konsistent effekt over 3 år på 41 % reduktion i risikoen for hoftefrakturer (95 % CI, 17 % til 58 %).
English: Tetracycline label was detectable in all but one of 82 biopsies obtained from patients on Aclasta.
Danish: Tetracyklinmarkering kunne påvises i alle, undtagen en, af de 82 biopsier fra patienter på Aclasta.
English: All cause mortality was 10% (101 patients) in the Aclasta-treated group compared to 13% (141 patients) in the placebo group.
Danish: All cause mortaliteten var 10 % (101 patienter) i gruppen behandlet med Aclasta sammenlignet med 13 % (141 patienter) i placebogruppen.
English: In another study in men (study CZOL446M2308) an annual infusion of Aclasta was non-inferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
Danish: I et andet studie, som omfattede mænd, (studie CZOL446M2308) var en årlig infusion af Aclasta noninferiør i forhold til ugentlig alendronat for den procentuelle ændring i lænderyg-BMD ved måned 24 i forhold til baseline.
English: Patients being treated with Aclasta should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Danish: Patienter, der behandles med Aclasta, må ikke behandles samtidig med sådanne lægemidler eller andre bisfosfonater, da den samlede effekt af disse lægemidler er ukendt.
English: Not known** Hypersensitivity reactions including rare cases of bronchospasm, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Danish: Ikke kendt** Hypersensitivitetsreaktioner inklusive sjældne tilfælde af bronkospasme, urticaria og angioødem og meget sjældne tilfælde af anafylaktisk reaktion/shock
English: The incidence of fractures was 8 for Aclasta-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Danish: Incidensen af frakturer var 8 for Aclastabehandlede patienter versus 7 for risedronatbehandlede patienter (p=0,8055).
English: Aclasta significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Danish: Aclasta reducerede incidensen af en eller flere nye vertebrale frakturer signifikant over 3 år og så tidligt som ved 1 år (se tabel 2).
English: This is especially important for the elderly (≥65 years)and for patients receiving diuretic therapy.
Danish: Dette gælder specielt for ældre patienter (≥65 år) og for patienter, som er i behandling med diuretika.
English: Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Aclasta, as directed by your doctor.
Danish: Sørg for at drikke tilstrækkelig væske (mindst 1 eller 2 glas) før og efter behandling med Aclasta, som din læge har fortalt dig.
English: Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5.
Danish: Omkring 42 % af patienterne havde en lårbenshals BMD T-score lavere end -2,5 og omkring 45 % af patienterne havde en lårbenshals BMD T-score over -2,5.
English: Aclasta contains sodium
Danish: Aclasta indeholder natrium
English: Aclasta is also used in patients who have recently broken their hip in a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.
Danish: Aclasta bruges også til patienter, der for nylig har brækket deres hofte ved et mindre uheld, fx ved fald, og som derfor har risiko for yderligere knoglebrud.
English: - After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Danish: - Efter åbning skal produktet bruges med det samme for at undgå mikrober.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.