FrancophonIA/ELRC3.0 huggingface dataset:
English: This is because Amoxil can affect the results of these tests.
Danish: skal du fortæl lægen eller sundhedspersonalet, at du tager Amoxil, da Amoxil kan påvirke resultatet af disse analyser.
English: Each 5 ml dose of oral suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin (50 mg per ml).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 5 ml dosis oral suspension indeholder amoxicillintrihydrat svarende til 250 mg amoxicillin (50 mg pr. ml).
English: maximum 500 mg twice daily
Danish: 10 til 30 Maksimalt 500 mg 2 gange daglig
English: Amoxil Powder for Solution for Injection or Infusion 250mg contains sodium • Amoxil contains 16 mg (0.68 mmol) of sodium and is essentially “sodium free”.
Danish: • Amoxil indeholder 16 mg (0,68 mmol) natrium, dvs. det er i det væsentlige natriumfrit.
English: 500 mg 1000 mg
Danish: 1.000 mg
English: 125 mg/1.25 ml powder for oral suspension (bottles) Amoxil 125 mg/1.25 ml powder for oral suspension is filled into clear glass bottles (Ph. Eur.
Danish: Amoxil 125 mg/1,25 ml pulver til oral suspension er fyldt i en klar glasflaske (Ph. Eur.
English: Oral:
Danish: Prægeblæk:
English: Pasteurella multocida
Danish: Listeria monocytogenes
English: How Amoxil is given
Danish: Sådan bliver du behandlet med Amoxil
English: Packs of 10 vials
Danish: Pakning med 10 hætteglas.
English: Lactose Monohydrate
Danish: Lactosemonohydrat
English: Convulsions
Danish: Hudreaktioner
English: The patient fully recovered the same day.
Danish: Patienten kom sig helt samme dag.
English: Therefore close monitoring in the first phase of treatment is important.
Danish: Derfor er det vigtigt med nøje overvågning i den første fase af behandlingen.
English: Consumption of grapefruit juice should be avoided.
Danish: Indtagelse af grapefrugtjuice skal undgås.
English: 86% of patients were less than 55 years old, 54% of them were male.
Danish: 86 % af patienterne var yngre end 55 år, og 54 % af dem var mænd.
English: Your doctor will carefully select the appropriate dose for your needs.
Danish: Lægen vil omhyggeligt vælge den passende dosis til dine behov.
English: Cariprazine is well absorbed after oral administration.
Danish: Cariprazin absorberes godt efter oral administration.
English: Cariprazine can be administered with or without food.
Danish: Cariprazin kan administreres med eller uden mad.
English: Tell your doctor if this happens.
Danish: Fortæl det til lægen, hvis det sker.
English: This patient experienced orthostasis and sedation.
Danish: Denne patient oplevede ortostase og sedation.
English: Contact your doctor for advice.
Danish: Kontakt din læge angående råd.
English: 95%CI
Danish: 95 %CI p-værdi
English: Some of these patients had confounding factors.
Danish: Visse af disse patienter havde forstyrrende faktorer.
English: *compared to placebo
Danish: *sammenlignet med placebo
English: Close medical supervision and monitoring should continue until the patient recovers.
Danish: Omhyggelig medicinsk kontrol og monitorering bør fortsætte, indtil patienten kommer sig.
English: The primary outcome of the study was time to relapse.
Danish: Studiets primære resultat var tid til recidiv.
English: This leaflet was last revised in <{MM/YYYY}> Other sources of information
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> Andre informationskilder
English: This is because the medicine will stay in your body for some time after the last dose was taken.
Danish: Årsagen til dette er, at lægemidlet fortsat vil være i din krop i nogen tid efter den sidste dosis.
English: Estimated Treatment Difference
Danish: Anslået behandlingsforskel
English: Tell your doctor immediately if you notice any signs of a stroke.
Danish: Fortæl straks lægen, hvis du bemærker tegn på et slagtilfælde.
English: to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Results for the secondary outcome parameter (CGI) and additional endpoints were supportive of the primary endpoint.
Danish: Resultaterne for det sekundære resultatsparameter (CGI) og yderligere endepunkter understøttede det primære endepunkt.
English: This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Danish: Dette lægemiddel bør ikke anvendes til børn og unge under 18 år på grund af mangel på data hos denne patientgruppe.
English: Results for the primary outcome parameter are summarized in Table 1 below.
Danish: Resultaterne for det primære resultatsparameter er opsummeret i tabel 1 nedenfor.
English: (See section “Pregnancy and breastfeeding”).
Danish: (Se afsnittet ”Graviditet og amning”).
English: If your doctor decides that you should take this medicine during pregnancy, your doctor will monitor your baby closely after birth.
Danish: Hvis lægen beslutter, at du skal tage dette lægemiddel under din graviditet, vil dit barn blive nøje overvåget efter fødslen.
English: Your doctor will therefore check your weight regularly.
Danish: Lægen vil derfor tjekke din vægt regelmæssigt.
English: This analysis included 2,844 patients of different races, involving 536 patients between the ages of 50 and 65.
Danish: Denne analyse omfattede 2.844 patienter af forskellige racer, hvoraf 536 patienter var mellem 50 og 65 år.
English: Your doctor will need to check your blood sugar regularly since it may be increased by Reagila.
Danish: Lægen skal tjekke dit blodsukker regelmæssigt, da det kan øges med Reagila.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Danish: En øget risiko med andre antipsykotika eller andre patientpopulationer kan ikke udelukkes.
English: Treatment difference versus placebo (95% CI)
Danish: Behandlingsforskel vs. placebo (95% CI)
English: Dose selection for an elderly patient should be more cautious.
Danish: Dosis til en ældre patient skal vælges med større forsigtighed.
English: Drowsiness, dizziness and vision problems may occur during treatment with this medicine (see section 4).
Danish: Der kan forekomme sløvhed, svimmelhed og synsproblemer under behandlingen med dette lægemiddel (se afsnit 4).
English: Allura red AC is a coloring agent, which may cause allergic reactions.
Danish: Allura red AC er et farvestof, som kan give allergiske reaktioner.
English: The effect of food on the exposure of the metabolites DCAR and DDCAR was also minimal.
Danish: Virkningen af mad på eksponeringen for metabolitterne DCAR og DDCAR var også minimal.
English: There are no or limited amount of data from the use of cariprazine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af cariprazin til gravide kvinder.
English: Reagila may cause significant weight increase which may affect your health.
Danish: Reagila kan forårsage betydelig vægtøgning, som kan påvirke din sundhed.
English: Of the 2,844 patients 933 were female (see section 4.2).
Danish: Af de 2.844 patienter var 933 kvinder (se pkt.
English: Your doctor will also inform you how to act if you switch from Reagila to another medicine.
Danish: Lægen vil også fortælle dig hvordan du skal agere, hvis du skifter fra Reagila til et andet lægemiddel.
English: For the management of patients treated with cariprazine, the effective half-life is more relevant than the terminal half-life.
Danish: Ved håndtering af patienter i behandling med cariprazin er den effektive halveringstid mere relevant end den terminale halveringstid.
English: The maximum dose should not exceed 6 mg once a day.
Danish: Den maksimale dosis bør ikke overstige 6 mg en gang dagligt.
English: Reagila is for oral use, to be taken once daily at the same time of the day with or without food.
Danish: Reagila er til oral anvendelse og skal tages en gang dagligt på samme tidspunkt på dagen med eller uden mad.
English: What Reagila contains
Danish: Reagila indeholder
English: Reagila contains the active substance cariprazine and belongs to a group of medicines called antipsychotics.
Danish: Reagila indeholder det aktive stof cariprazin og tilhører en gruppe af lægemidler kaldet antipsykotika.
English: The effect of cariprazine on human fertility has not been evaluated.
Danish: Virkningen af cariprazin på human fertilitet er ikke blevet undersøgt.
English: Consequently, newborns should be monitored carefully.
Danish: Derfor skal spædbørn overvåges omhyggeligt.
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Danish: Du må ikke køre bil eller arbejde med værktøj eller maskiner, før du ved, om dette lægemiddel påvirker dig negativt.
English: These may be signs of muscle damage which can cause very serious kidney problems.
Danish: Dette kan være tegn på muskelskade, som kan forårsage meget alvorlige nyreproblemer.
English: The lowest effective dose should be maintained according to the clinical judgement of the treating physician.
Danish: Den laveste virkningsfulde dosis bør fastholdes i henhold til den behandlende læges kliniske vurdering.
English: There is no specific antidote to cariprazine.
Danish: Der er ingen specifik antidot mod cariprazin.
English: Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias.
Danish: Kardiovaskulær monitorering bør iværksættes straks og bør omfatte kontinuerlig elektrokardiografisk monitorering for eventuel arytmi.
English: Most events were mild to moderate in severity.
Danish: De fleste hændelser var lette til moderate.
English: Even if you feel better, do not alter or stop your daily dose of Reagila unless told to do so by your doctor as your symptoms may return.
Danish: Selv hvis du får det bedre, må du ikke holde op med at tage din daglige dosis Reagila eller ændre dosis, medmindre du får besked på det af lægen, da dine symptomer ellers kan vende tilbage.
English: Thereafter, the dose may be slowly adjusted by your doctor, in steps of 1.5 mg, depending on how the treatment works for you.
Danish: Derefter vil din læge muligvis langsomt tilpasse din dosis i trin på 1,5 mg, afhængigt af hvordan behandlingen virker for dig.
English: Blood pressure should be monitored.
Danish: Blodtrykket skal overvåges.
English: Detailed and updated information on this medicine is available by scanning the QR code below and the outer carton with a smartphone.
Danish: Du kan få detaljerede og opdaterede oplysninger om dette lægemiddel ved at scanne QR-koden nedenfor eller på yderpakningen med en smartphone.
English: In elderly patients above 65 years of age data are limited.
Danish: Der foreligger begrænsede data for ældre patienter over 65 år.
English: Do not breast-feed if you are taking Reagila because a risk for the baby cannot be excluded.
Danish: Du må ikke amme, hvis du tager Reagila, da risiko for barnet ikke kan udelukkes.
English: The clinical consequences of this effect is not fully understood, however the use of P-gp substrates with narrow therapeutic index such as dabigatran and digoxin could require extra monitoring and dose adjustment.
Danish: De kliniske følger af denne virkning kendes ikke fuldt ud, men anvendelse af P-gp-substrater med snævert terapeutisk indeks som f.eks. dabigatran og digoxin kan kræve ekstra overvågning og dosisjustering.
English: The safety and efficacy of cariprazine in children and adolescents aged less than 18 years have not been established.
Danish: Cariprazins sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
English: The blisters are packed in a folded carton box.
Danish: Blisterne er pakket i en foldet kartonæske.
English: Most EPS cases were mild to moderate in intensity and could be handled with common anti-EPS medicinal products.
Danish: De fleste tilfælde af EPS var lette til moderate i intensitet og kunne behandles med almindelige lægemidler mod EPS.
English: Cariprazine and its major active metabolites are highly bound (96 to 97% for CAR, 94% to 97% for DCAR and 92% to 97% for DDCAR) to plasma proteins.
Danish: Cariprazin og dets vigtigste aktive metabolitter har høj binding (96 til 97 % for CAR, 94 % til 97 % for DCAR og 92 % til 97 % for DDCAR) til plasmaproteiner.
English: Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Danish: Selvmordstanker og selvmordsadfærd forekommer oftest i begyndelsen af behandlingen.
English: Table 2 Summary of results in study RGH-188-005
Danish: Tabel 2 Oversigt over resultaterne af studie RGH-188-005 Virkningsparameter
English: Do not take this medicine during pregnancy unless your doctor has told you to do so.
Danish: Du må ikke tage dette lægemiddel, hvis du er gravid, medmindre din læge har anvist det.
English: You cannot take certain medicines together with Reagila (see section “Do not take Reagila”).
Danish: Der er visse lægemidler, du ikke må tage sammen med Reagila (se afsnittet ”Tag ikke Reagila”).
English: There is a minor or moderate risk that the medicine could affect the ability to drive and use machines.
Danish: Der er en mindre eller moderat risiko for, at lægemidlet vil kunne påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: PANSS total (MMRM) RGH-MD-16 (n=711)
Danish: Samlet PANSS (MMRM) RGH-MD-16 (n=711)
English: Accidental acute overdose (48 mg/day) was reported in one patient.
Danish: Der blev rapporteret om utilsigtet akut overdosering (48 mg/dag) hos én patient.
English: Reagila with food, drink and alcohol You should not drink grapefruit juice during treatment with Reagila.
Danish: Brug af Reagila sammen med mad, drikke og alkohol Du må ikke drikke grapefrugtjuice, mens du er i behandling med Reagila.
English: Cariprazine has not been studied in elderly patients with dementia and is not recommended to treat elderly patients with dementia due to increased risk of overall mortality.
Danish: Cariprazin er ikke undersøgt hos ældre patienter med demens, og det frarådes at behandle ældre patienter med demens, pga.øget overordnet dødelighedsrisiko.
English: Holter monitor-derived electrocardiographic assessments were obtained in 129 patients over a twelve hour period at baseline and steady state.
Danish: Der blev foretaget Holter-monitorafledte elektrokardiografiske vurderinger af 129 patienter i en tolvtimers periode ved baseline og steady state.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cariprazine in paediatric population.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med cariprazin i den pædiatriske population.
English: Because cariprazine is not a substrate for CYP1A2, smoking is not expected to have an effect on the pharmacokinetics of cariprazine.
Danish: Da cariprazin ikke er et substrat for CYP1A2, forventes rygning ikke at have en virkning på cariprazins farmakokinetik.
English: Tardive dyskinesia is a syndrome consisting of potentially irreversible, rhythmical, involuntary movements, predominantly of the tongue and/or face that can develop in patients treated with antipsychotics.
Danish: Tardiv dyskinesi er et syndrom, som består af potentielt irreversible, rytmiske, ufrivillige bevægelser, overvejende af tungen og/eller ansigtet, som patienter i behandling med antipsykotika kan udvikle.
English: The plasma concentration of total cariprazine will gradually decline following dose discontinuation or interruption.
Danish: Plasmakoncentrationen af total cariprazin vil falde gradvist efter seponering eller afbrydelse.
English: P-glycoprotein (P-gp) substrates
Danish: P-glykoprotein-substrater (P-gp-substrater)
English: The mechanism of action of cariprazine is not fully known.
Danish: Cariprazins virkningsmekanisme er ikke helt kendt.
English: Time to relapse (92 vs. 326 days-based on the 25th percentile) was therefore significantly longer in the cariprazine group than in the placebo group (p=0.009).
Danish: Tid til recidiv (92 kontra 326 dage - baseret på den 25. percentil) var derfor signifikant længere i cariprazin-gruppen end i placebogruppen (p=0,009).
English: Reproductive performance of the first generation pups was unaffected; however, second generation pups also had similar clinical signs and lower body weight.
Danish: Førstegenerationsafkommets reproduktive evner var ikke berørt, men andengenerationsafkommet havde også lignende kliniske tegn og lavere legemsvægt.
English: Significant weight gain has been observed with the use of cariprazine.
Danish: Der er observeret betydelig vægtstigning ved anvendelse af cariprazin.
English: Tell your doctor immediately: - if you are having any thoughts or feelings about hurting yourself or to commit suicide.
Danish: Fortæl det straks til lægen: - hvis du har tanker eller følelser om at ville skade dig selv eller begå selvmord.
English: - high or low blood pressure, cardiovascular disease.
Danish: - har for højt eller lavt blodtryk eller hjerte/kar-sygdom.
English: Cariprazine is a P-gp inhibitor in vitro at its theoretical maximum intestinal concentration.
Danish: Cariprazin er en P-gp-hæmmer in vitro ved sin teoretisk maksimale tarmkoncentration.
English: Given the primary central nervous system effects of cariprazine, Reagila should be used with caution in combination with other centrally acting medicinal products and alcohol.
Danish: Som følge af cariprazins primære virkning på centralnervesystemet bør der udvises forsigtighed, når Reagila anvendes i kombination med andre centralt virkende lægemidler og alkohol.
English: The effective (functional) half-life is ~ 2 days for cariprazine and DCAR, 8 days for DDCAR and is ~1 week for total cariprazine.
Danish: Den effektive (funktionelle) halveringstid er ~2 dage for cariprazin og DCAR, 8 dage for DDCAR og ~1 uge for total cariprazin.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX15
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, andre antipsykotika, ATC-kode: N05AX15
English: Do not take Reagila: - if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Reagila: - hvis du er allergisk over for cariprazin eller et af de øvrige indholdsstoffer i Reagila (angivet i afsnit 6).
English: The possibility of suicidality (suicidal ideation, suicide attempt and completed suicide) is inherent in psychotic illnesses and, generally, it is reported early after initiation or switch of antipsychotic therapy.
Danish: Risikoen for selvmordsadfærd (selvmordstanker, selvmordsforsøg og gennemført selvmord) er en del af psykotisk sygdom og rapporteres generelt at forekomme kort efter initiering eller ændring af antipsykotisk behandling.
English: It is unknown whether cariprazine or its major active metabolites are excreted in human milk.
Danish: Det er ukendt, om cariprazin eller dets vigtigste aktive metabolitter udskilles i human mælk.
English: Your doctor will need to check your blood pressure regularly.
Danish: Lægen skal tjekke dit blodtryk regelmæssigt.
English: SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton in order to protect from light.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar blisteren i den ydre karton for at beskytte mod lys.
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, cariprazine must be discontinued immediately.
Danish: Hvis patienten udvikler tegn og symptomer på NMS eller uforklarligt får høj feber uden andre kliniske manifestationer af NMS, skal cariprazin straks seponeres.
English: Suicidal behaviour Delirium Depression Libido decreased Libido increased Erectile dysfunction
Danish: Selvmordsadfærd Delirium Depression Nedsat libido Øget libido Erektil dysfunktion
English: Potential for cariprazine to affect other medicinal products
Danish: Potentialet for, at cariprazin kan påvirke andre lægemidler
English: Reagila is indicated for the treatment of schizophrenia in adult patients.
Danish: Reagila er indiceret til behandling af skizofreni hos voksne patienter.
English: No QT interval prolongation was detected following supratherapeutic doses (9 mg/day or 18 mg/day).
Danish: Der blev ikke påvist forlængelse af QT-intervallet efter supraterapeutiske doser (9 mg/dag eller 18 mg/dag).
English: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with Reagila does not affect them adversely.
Danish: Patienten skal advares mod at betjene farlige maskiner og føre motorkøretøj, indtil der er rimelig vished for, at behandlingen med Reagila ikke påvirker patienten.
English: If your baby develops any of these symptoms you should contact your doctor.
Danish: Hvis dit barn får nogle af disse symptomer, skal du kontakte lægen.
English: It is used to treat adults with schizophrenia.
Danish: Det bruges til behandling af voksne med skizofreni.
English: No significant relationship was found between cariprazine plasma clearance and creatinine clearance.
Danish: Der blev ikke fundet noget signifikant forhold mellem plasmaclearance af cariprazin og kreatininclearance.
English: Absolute bioavailability of cariprazine is unknown.
Danish: Cariprazins absolutte biotilgængelighed er ukendt.
English: This is because the following symptoms may occur in newborn babies of mothers who have used this medicine in the last trimester (last three months) of their pregnancy: - shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Det er fordi der kan forekomme de følgende symptomer hos nyfødte af mødre, som har brugt dette lægemiddel i det sidste trimester (de sidste tre måneder) af graviditeten: - rysten, muskelstivhed og/eller -svaghed, søvnighed, ophidselse, vejrtrækningsproblemer og besvær med at indtage føde.
English: If you have serious kidney or liver problems Reagila may not be appropriate for you.
Danish: Hvis du har alvorlige problemer med nyrerne eller leveren, er Reagila måske ikke egnet til dig.
English: Following administration of 12.5 mg/day cariprazine to patients with schizophrenia, 20.8% of the dose was excreted in urine as cariprazine and its metabolites.
Danish: Efter administration af cariprazin 12,5 mg/dag til patienter med skizofreni blev 20,8 % af dosen udskilt i urinen som cariprazin og dets metabolitter.
English: The dose can be modified based on individual response and tolerability (see section 4.8).
Danish: Dosis kan justeres på baggrund af det individuelle respons og den individuelle tolerabilitet (se pkt.
English: Hormonal contraceptives
Danish: Hormonelle antikonceptiva
English: Patients with secondary negative symptoms, such as moderate to severe depressive symptoms and clinically relevant parkinsonism (EPS) were excluded.
Danish: Patienter med sekundære negative symptomer som for eksempel symptomer på moderat til svær depression og klinisk relevante symptomer på Parkinsons sygdom (EPS) blev ekskluderet.
English: Reagila should not be used by elderly patients with dementia (loss of memory).
Danish: Reagila må ikke tages af patienter med demens (hukommelsestab).
English: ECG changes
Danish: EKG-ændringer
English: Blood pressure changes
Danish: Blodtryksændringer
English: However, a causal relationship between lenticular changes / cataracts observed in human studies and cariprazine use has not been established.
Danish: Men en årsagssammenhæng mellem linseændringer/katarakt observeret i undersøgelser af forsøgspersoner og cariprazin er ikke etableret.
English: Baseline Mean ± SD
Danish: Baseline, middel ± SD
English: At steady state, exposure to DDCAR is approximately two to three-fold higher than to cariprazine, and exposure to DCAR is approximately 30% of cariprazine exposure.
Danish: Ved steady state er eksponering for DDCAR ca. to til tre gange højere end for cariprazin, og eksponering for DCAR er ca. 30 % af eksponeringen for cariprazin.
English: Pregelatinized (maize) starch Magnesium stearate
Danish: Prægelatiniseret (majs-) stivelse Magnesiumstearat
English: These symptoms may occur early during treatment with Reagila.
Danish: Disse symptomer kan forekomme ved behandling med Reagila.