FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 50 mg ibandronsyre (som ibandronnatrium monohydrat).
English: Ibandronic acid Sandoz 50 mg film-coated tablets ibandronic acid
Danish: Ibandronsyre Sandoz 50 mg filmovertrukne tabletter ibandronsyre
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis du har yderligere spørgsmål vedrørende brugen af denne medicin.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Du skal især fortælle din læge eller apotekspersonalet, hvis du tager en eller flere af følgende medicintyper:
English: (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
Danish: Du kan have tegn på et mavesår i den første del af tarmen (duodenum), der bløder, eller gastrointestinal inflammation (gastritis).
English: NAME OF THE MEDICINAL PRODUCT Ibandronic acid Sandoz 50 mg film-coated tablets
Danish: 1 LÆGEMIDLETS NAVN Ibandronsyre Sandoz 50 mg filmovertrukne tabletter
English: Do not take Ibandronic acid Sandoz:
Danish: Tag ikke Ibandronsyre Sandoz
English: Hepatic impairment (see section 4.2)
Danish: Pædiatrisk population (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Ibandronic acid Sandoz 50 mg film-coated tablets ibandronic acid
Danish: LÆGEMIDLETS NAVN Ibandronsyre Sandoz 50 mg filmovertrukne tabletter ibandronsyre
English: Greece
Danish: Grækenland og
English: Therefore, ibandronic acid should not be used during pregnancy.
Danish: Den potentielle risiko hos mennesker kendes ikke, hvorfor Ibandronsyre ikke bør anvendes under graviditet.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Tal med din læge eller apotekspersonalet, hvis du får bivirkninger.
English: What Ibandronic acid Sandoz is and what it is used for What you need to know before you take Ibandronic acid Sandoz How to take Ibandronic acid Sandoz Possible side effects
Danish: Det skal du vide, før du begynder at tage Ibandronsyre Sandoz Sådan skal du tage Ibandronsyre Sandoz Bivirkninger
English: Elderly (see section 4.2)
Danish: Ældre (se pkt.
English: Therefore, with such products, including food, intake must be delayed at least 30 minutes following oral administration.
Danish: Indtagelse af sådanne produkter, herunder føde, må derfor først påbegyndes mindst 30 minutter efter peroral Ibandronsyre Sandoz indtagelse.
English: Musculoskeletal and connective tissue disorders
Danish: Mikrokrystallinsk cellulose Crospovidon
English: How to store Ibandronic acid Sandoz
Danish: Opbevaring af Ibandronsyre Sandoz
English: This is because NSAIDs and Ibandronic acid Sandoz can both irritate your stomach and gut a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Danish: Dette er fordi, NSAID-præparater og Ibandronsyre Sandoz begge kan irritere mave og tarm.
English: Hepatic impairment
Danish: Knoglenekrose i kæben
English: Common (may affect up to 1 in 10 people): • feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)
Danish: • kvalme, halsbrand eller ubehag ved at synke (betændelse i spiserøret).
English: How to take Ibandronic acid Sandoz
Danish: Sådan skal du tage Ibandronsyre Sandoz
English: Talk to your doctor or pharmacist before taking Ibandronic acid Sandoz • if you are allergic to any other bisphosphonates
Danish: Fortæl det til din læge eller apotekspersonalet før du tager Ibandronsyre Sandoz
English: Before receiving treatment, tell your doctor/nurse (health care professional) if:
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på:
English: The absolute oral bioavailability of the tablet formulation is 87%.
Danish: Den absolutte orale biotilgængelighed af tabletformuleringen er 87 %.
English: The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks.
Danish: Behandlingsvarigheden bør være den kortest mulige til symptomkontrol og må ikke overstige 12 uger.
English: It does not matter whether you take it with or without food.
Danish: Det betyder ikke noget om du tager dem sammen med et måltid eller ej.
English: Try to take Aripiprazole Zentiva at the same time each day.
Danish: Forsøg at tage Aripiprazole Zentiva på samme tidspunkt hver dag.
English: • Unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: • Usædvanlige bevægelser (især i ansigtet og med tungen) og nedsat bevidsthedsniveau.
English: Consequently, the frequency of these adverse events is qualified as “not known”.
Danish: Hyppigheden af sådanne bivirkninger er derfor angivet som "ikke kendt".
English: • inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Danish: • manglende evne til at modstå trangen eller fristelsen til at udføre en handling, der kan være skadelig for dig selv eller andre, og som kan omfatte:
English: • thoughts of suicide, suicide attempt and suicide;
Danish: • selvmordstanker, selvmordsforsøg og selvmord,
English: Do not stop your treatment just because you feel better.
Danish: Du må ikke stoppe med at tage lægemidlet, fordi du har fået det bedre.
English: OPA/Alu/PVC/Alu foil blisters (Alu-Alu blister), carton box.
Danish: OPA/Alu/PVC/Alu-folie blister (Alu-Alu blister), kartonæske.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2015
Danish: Dato for første markedsføringstilladelse: 25. juni 2015
English: Name and address of the manufacturer responsible for batch release Zentiva SA
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Zentiva SA
English: Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
Danish: Interaktion med andre receptorer end dopaminog serotonin-subtyper kan forklare nogle af de andre kliniske virkninger af aripiprazol.
English: Valproate and lithium
Danish: Valproat og lithium
English: Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Zentiva without first consulting your doctor.
Danish: Selvom du føler du har det bedre, må du ikke ændre eller lade være med at tage den daglige dosis af Aripiprazole Zentiva uden først at have kontaktet lægen.
English: In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74% of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Danish: I en delanalyse af de unge patienter mellem 15 og 17 år, som repræsenterede 74 % af den totale inkluderede population, blev effekten bibeholdt i det 26-ugers åbne, forlængelsesforsøg.
English: United Kingdom Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
Danish: Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
English: Method of administration Aripiprazole Zentiva is for oral use.
Danish: Administration Aripiprazole Zentiva er til oral anvendelse.
English: Blood pressure-lowering medicines: Aripiprazole Zentiva may increase the effect of medicines used to lower the blood pressure.
Danish: Blodtrykssænkende medicin: Aripiprazole Zentiva kan forstærke virkningen af medicin, der bruges til at sænke blodtrykket.
English: Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Danish: Mindre end 1 % uomdannet aripiprazol blev udskilt i urinen, og ca. 18 % blev genfundet uomdannet i fæces.
English: In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Zentiva.
Danish: Hos voksne forebygger det også, at tilstanden vender tilbage hos patienter, der har haft god effekt af behandling med Aripiprazole Zentiva.
English: Before treatment with Aripiprazole Zentiva, tell your doctor if you suffer from
Danish: Inden du bliver behandlet med Aripiprazole Zentiva, skal du fortælle lægen, hvis du lider af
English: Aripiprazole Zentiva contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Danish: Aripiprazole Zentiva indeholder det aktive stof aripiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin.
Danish: Ved terapeutiske koncentrationer bindes aripiprazol og dehydroaripiprazol mere end 99 % til serumproteiner, primært til albumin.
English: The highest non-tumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
Danish: Den højeste ikke-tumorfremkaldende eksponering hos hunrotter var 7 gange den anbefalede humane dosis.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.
Danish: Denne medicin indeholder under 1 mmol sodium (23 mg) pr. tablet og er således nærmest ”sodiumfri”.
English: Class effect - Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Danish: Klasseeffekt - der kan forekomme symptomer på dystoni, længerevarende anormale sammentrækninger af muskelgrupper hos modtagelige individer i de første par dage af behandlingen.
English: Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 - 5 hours after dosing.
Danish: Aripiprazol absorberes godt, med maksimal plasmakoncentration inden for 3 - 5 timer efter administration.
English: Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Danish: Pludselig uforklarlig død Torsades de pointes QT-forlængelse Ventrikulære arytmier Hjertestop
English: • blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
Danish: • blodpropper i venerne, særligt i benene (symptomer omfatter hævelse, smerter og rødme i benet), der kan vandre gennem blodårerne til lungerne medførende smerte i brystet samt vejrtrækningsbesvær (søg straks læge, hvis du bemærker nogle af disse symptomer),
English: In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable to that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions on development.
Danish: I forsøg med gentagne doser hos juvenile rotter og hunde var aripiprazols toksicitetsprofil sammenlignelig med den, der blev observeret hos voksne dyr, og der var intet, der tydede på neurotoksicitet eller bivirkninger på udviklingen.
English: Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Danish: Aripiprazole Zentiva er indiceret til behandling af skizofreni hos voksne og unge i alderen 15 år og opefter.
English: If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Danish: Hvis du er ældre og lider af demens (hukommelsestab og tab af andre mentale evner), skal din familie eller din kontaktperson informere lægen om eventuelle slagtilfælde eller forbigående slagtilfælde.
English: All ADRs are listed by system organ class and frequency; 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) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60% in the faeces.
Danish: Efter enkelt oral dosis af 14C-mærket aripiprazol, blev ca. 27 % af den administrerede radioaktivitet genfundet i urinen og cirka 60 % i fæces.
English: Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
Danish: Medicinsk kul (50 g) administreret en time efter aripiprazol nedsatte aripiprazol Cmax med omkring 41 % og AUC med omkring 51 %; dette viser, at kul kan være effektivt i behandlingen af overdosering.
English: However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in the 39-week study and are well below (6%) their limits of in vitro solubility.
Danish: Koncentrationerne af sulfatkonjugat af hydroxyaripiprazol i den humane galdeblære ved den højeste foreslåede dosis (30 mg/dag) var dog ikke mere end 6 % af de galdekoncentrationer, der sås hos aber i 39-ugers forsøget og lå godt under (6 %) grænserne for in vitro opløselighed.
English: • Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Danish: • visse antibiotika mod tuberkulose (rifabutin, rifampicin)
English: Increased Alanine Aminotransferase (ALT)
Danish: Forhøjet alanin-aminotransferase (ALAT)
English: Caution should be taken when treating patients at higher risk, and a lower starting dose should be considered (e.g., elderly or debilitated patients; see section 4.2).
Danish: Der skal udvises forsigtighed ved behandling af patienter med høj risiko, og en lavere startdosis bør overvejes (fx ældre eller svækkede patienter; se pkt.
English: If you are taking Aripiprazole Zentiva, your doctor will discuss with you whether you should breast feed considering the benefit to you of your therapy and the benefit to your baby of breast feeding.
Danish: Hvis du tager Aripiprazole Zentiva, vil din læge drøfte med dig, om du bør amme dit barn, ved at se på fordelen for dig ved behandling og fordelen ved amning for barnet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the reference medicinal product containing aripiprazole in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referenceproduktet der indeholder aripiprazol i en eller flere undergrupper af den pædiatriske population ved behandling af skizofreni og bipolær lidelse (se pkt.
English: Aripiprazole Zentiva is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Danish: Aripiprazole Zentiva bruges til at behandle voksne og unge i alderen 13 år og ældre, som lider af en sygdom, der er forbundet med symptomer som fx at føle sig "høj", en overdreven mængde energi, behov for meget mindre søvn end sædvanligt, meget hurtig tale med et væld af idéer og nogle gange voldsom irritabilitet.
English: When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section
Danish: Om nødvendigt skal en efterfølgende øgning af dosis ske trinvist med 5 mg uden at overskride den maksimale daglige dosis på 30 mg (se pkt.
English: 14 tablets 28 tablets 49 tablets 56 tablets 98 tablets
Danish: Tabletter 14 tabletter 28 tabletter 49 tabletter 56 tabletter 98 tabletter
English: It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Danish: Det bruges til at behandle voksne og unge i alderen 15 år og opefter for sygdom, der er forbundet med at høre, se eller føle ting, som ikke er der, mistænksomhed, misopfattelse, usammenhængende tale og opførsel samt nedslået stemningsleje.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (aripiprazole 77% and haloperidol 73%).
Danish: I et kontrolleret forsøg med haloperidol var andelen af responderende patienter, der opretholdt respons på lægemidlet efter 52 uger, den samme i begge grupper (aripiprazol 77 % og haloperidol 73 %).
English: This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.
Danish: Der skal tages hensyn til dette i situationer, der kræver fuld opmærksomhed, fx ved bilkørsel eller betjening af maskiner.
English: Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17% of patients, with tremor accounting for 6.5%.
Danish: Ekstrapyramidale symptomer blev rapporteret hos 17 % af patienterne, hovedsageligt i stabiliseringsfasen; heraf udgjorde tremor 6,5 %.
English: Pathological gambling and other impulse control disorders Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Danish: Ludomani og andre forstyrrelser af impulskontrollen Patienter kan opleve forskellige former for øget trang, især til hasardspil, og manglende evne til at styre denne trang, når de tager aripiprazol.
English: The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%, respectively.
Danish: AUC og Cmax for dehydro-aripiprazol, den aktive metabolit, reduceredes med henholdsvis 32 % og 47 %.
English: Czech Republic
Danish: Česká republika
English: • Rapid heartbeat, agitation/aggressiveness, problems with speech.
Danish: • Hjertebanken, uro/aggressivitet, talebesvær.
English: Potential for other medicinal products to affect aripiprazole A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Danish: Andre lægemidler, der kan påvirke optagelsen af aripiprazol Syreblokkeren og H2-antagonisten famotidin nedsætter absorptionshastigheden for aripiprazol, men denne virkning synes ikke klinisk relevant.
English: Among the patients included in the primary efficacy analysis, 139 patients had a current comorbid diagnosis of ADHD.
Danish: Blandt patienterne, inkluderet i den primære effektanalyse, var 139 patienter diagnosticeret med ADHD som comorbiditet.
English: Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline.
Danish: Patienterne var 7 - 17 år og havde en gennemsnitlig baseline-score for samlede tics (Total Tic Score) på 30 på Yale Global Tic Severity-skalaen (TTS-YGTSS).
English: Talk to your doctor before taking Aripiprazole Zentiva.
Danish: Kontakt lægen, før du tager Aripiprazole Zentiva.
English: According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Danish: På baggrund af den metaboliske vej for aripiprazol, er dosisjustering for rygere ikke påkrævet (se pkt 4.5).
English: Aripiprazole Zentiva is effective in a dose range of 10 to 30 mg/day.
Danish: Aripiprazole Zentiva er effektivt i et dosisinterval på 10 til 30 mg/dag.
English: The most commonly reported adverse reactions in placebo-controlled trials were akathisia and nausea each occurring in more than 3% of patients treated with oral aripiprazole.
Danish: De hyppigst rapporterede bivirkninger i placebokontrollerede forsøg var akatisi og kvalme, som hver forekom hos mere end 3 % af de patienter, der blev behandlet med oral aripiprazol.
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78 - 88 years).
Danish: Der er i de samme forsøg rapporteret cerebrovaskulære bivirkninger (fx apopleksi og transitorisk iskæmi (TIA)) samt dødsfald hos patienter (gennemsnitsalder: 84 år; aldersspænd: 78 - 88 år).
English: At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.
Danish: Ved steady-state repræsenterer dehydro-aripiprazol, den aktive metabolit, omkring 40% af aripiprazol AUC i plasma.
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1%, 30 mg, 28.8%, placebo, 1.7%,); and akathisia (incidences were 10 mg, 12.1%, 30 mg, 20.3%, placebo, 1.7%).
Danish: Følgende bivirkninger har et muligt dosis-respons-forhold: ekstrapyramidale symptomer (incidensen var 10 mg: 9,1 %; 30 mg: 28,8 %; placebo: 1,7 %) og akatisi (incidensen var 10 mg: 12,1 %; 30 mg: 20,3 %; placebo: 1,7 %).
English: • Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
Danish: • Akut forvirring, krampeanfald (epilepsi), koma, en kombination af feber, hurtig vejrtrækning,
English: Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Danish: Ligeledes var de geometriske middelværdier for dehydro-aripiprazol for Cmax og AUC efter samtidig brug af carbamazepin henholdsvis 69 % og 71 % lavere end ved behandling med aripiprazol alene.
English: Manufacturer S.C. Zentiva S.A.
Danish: S.C. Zentiva S.A.
English: Potential for aripiprazole to affect other medicinal products In clinical studies, 10 - 30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Danish: I kliniske forsøg havde en daglig dosis på 10 - 30 mg aripiprazol ingen signifikant effekt på metabolismen af CYP2D6-substrater (dextromethorphan/3-methoxymorphinan forholdet), CYP2C9 (warfarin), CYP2C19 (omeprazol) og CYP3A4 (dextromethorphan).
English: The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
Danish: Følgende bivirkninger er blevet rapporteret efter markedsføring af oral aripiprazol, men deres hyppighed er ikke kendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data):
English: Concomitant administration of aripiprazole and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Danish: Samtidig administration af aripiprazol og andre CYP3A4-induktorer (fx rifampicin, rifabutin, fenytoin, fenobarbital, primidon, efavirenz, nevarapin og perikon) kan forventes at have lignende virkninger, og lignende dosisøgninger bør derfor anvendes.
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107%, while Cmax was unchanged.
Danish: I et klinisk forsøg med raske personer øgede en stærk CYP2D6-hæmmer (quinidin) aripiprazols AUC med 107 %, mens Cmax var uforandret.