natgillin/translations-raw huggingface dataset:
Reagila 1,5 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 1,5 mg cariprazin.
Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
De hyppigste bivirkninger er anført først.
Adverse reactions are ranked by frequency, the most frequent first, using the following convention:
Forhøjede leverenzymer
Weigth increase
Der blev observeret udvikling af katarakt i prækliniske studier med cariprazin (se pkt.
Development of cataracts was observed in cariprazine non-clinical studies (see section 5.3).
Nyrer og urinveje
Seizures and convulsions
Reagila 4,5 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 4,5 mg cariprazin.
Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Patienterne havde forskellige grader af nyrefunktion, herunder normal nyrefunktion (kreatininclearance (CrCl) ≥ 90 ml/min) samt let (CrCl
Population pharmacokinetic modelling was performed using data from patients enrolled in the schizophrenia cariprazine clinical program with differing levels of renal function, including normal renal function (creatinine clearance (CrCl) ≥ 90 mL/min), as well as mild (CrCl 60 to 89 mL/min) and moderate (CrCl 30 to 59 mL/min) renal impairment.
Reagila 6 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 6 mg cariprazin.
Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Reagila 3 mg: Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 3 mg cariprazin.
Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 1,5 mg cariprazin.
Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Anvendelse af cariprazin til patienter med svært nedsat leverfunktion frarådes (se pkt.
Use of cariprazine is not recommended in patients with severe renal impairment (see section 5.2).
1 LÆGEMIDLETS NAVN Reagila 1,5 mg hårde kapsler cariprazin
NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules cariprazine
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/029-036
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/029-036
1 LÆGEMIDLETS NAVN Reagila 4,5 mg hårde kapsler cariprazin
NAME OF THE MEDICINAL PRODUCT Reagila 4.5 mg hard capsules cariprazine
- angst - søvnighed, søvnproblemer, unormale drømme, mareridt, gå i søvne - svimmelhed - ufrivillige vridende bevægelser og mærkelige stillinger (dystoni) - overdreven tænderskæren eller spænding af kæben, savlen, vedvarende blinken ved banken på
- anxiety - sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking - dizziness - involuntary twisting movements and strange postures - excessive teeth grinding or jaw clenching, drooling, persistent blinking in response to tapping of the forehead (an abnormal reflex), movement problems, tongue movement disturbance (these are called extrapyramidal symptoms) - blurred vision - high blood pressure - fast, irregular heartbeat - decreased or increased appetite - nausea, vomiting, constipation - weight increased - tiredness - the following can be seen in laboratory tests:
Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 4,5 mg cariprazin.
Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 6 mg cariprazin.
Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
1 LÆGEMIDLETS NAVN Reagila 6 mg hårde kapsler cariprazin
NAME OF THE MEDICINAL PRODUCT Reagila 6 mg hard capsules cariprazine
Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 3 mg cariprazin.
Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Hypothyroidisme
Hypothyroidis m
1 LÆGEMIDLETS NAVN Reagila 3 mg hårde kapsler cariprazin
NAME OF THE MEDICINAL PRODUCT Reagila 3 mg hard capsules cariprazine
Reagila 1,5 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, titandioxid (E171), gelatine, sort blæk (shellak, sort jernoxid (E172), propylenglycol, kaliumhydroxid).
Reagila 1.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 1,5 mg cariprazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Gradvis krydstitrering er ikke nødvendig ved skift fra cariprazin til et andet antipsykotikum.
Switching to another antipsychotic from cariprazine When switching to another antipsychotic from cariprazine, no gradual cross-titration is needed, the new antipsychotic should be initiated in its lowest dose while cariprazine is discontinued.
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 0,0096 mg Allura red AC (E129).
Each hard capsule contains 0.0096 mg Allura red AC (E 129).
Den CYP2D6-medierede rute spiller en mindre rolle for metaboliseringen af cariprazin.
CYP2D6 mediated pathway plays a minor role in the metabolism of cariprazine, the major pathway is via CYP3A4 (see section 5.2).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/021-028
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/021-028
- Reagila 4,5 mg hårde kapsler: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og grøn, uigennemsigtig underdel, præget med “GR 4.5” på kapslens underdel med hvidt blæk.
- Reagila 4.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 0,0008 mg Allura red AC (E129).
Each hard capsule contains 0.0008 mg Allura red AC (E 129).
- Reagila 1,5 mg hårde kapsler: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med hvid, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 1.5” på kapslens underdel med sort blæk.
- Reagila 1.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/001-040
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-040
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 4,5 mg cariprazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
- Reagila 3 mg hårde kapsler: Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 3” på kapslens underdel med sort blæk.
- Reagila 3 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Reagila 4,5 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, Allura red AC (E129), Brilliant blue FCF (E133), titandioxid (E171), gul jernoxid (E172), gelatine, hvidt blæk (shellak, titandioxid (E171), propylenglycol, simeticon).
Reagila 4.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/011-020
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/011-020
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1209/001-010
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-010
Reagila 6 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, Brilliant blue FCF (E133), Allura red AC (E129), titandioxid (E171), gelatine, sort blæk (shellak, sort jernoxid (E172), propylenglycol, kaliumhydroxid).
Reagila 6 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
- Reagila 6 mg hårde kapsler: Hård gelatinekapsel i str. 3 (ca. 15,9 mm lang) med lilla, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 6” på kapslens underdel med sort blæk.
- Reagila 6 mg hard capsules: ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Malignt neuroleptikasyndrom
Nervous system disorders
Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 0,0003 mg Allura red AC (E129).
Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Uklar linse/katarakt
Lens opacity/Cataract
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 6 mg cariprazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder cariprazinhydrochlorid svarende til 3 mg cariprazin.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Hvis du har taget for meget Reagila
If you take more Reagila than you should
Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 3” på kapslens underdel med sort blæk.
‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
° anæmi (lavt antal røde blodlegemer) ° højt antal af en type hvide blodlegemer ° lavt indhold af skjoldbruskkirtel-hormon (thyroideastimulerende hormon, TSH) i blodet
° anaemia (reduced levels of red blood cells)
Reagila 3 mg hårde kapsler: prægelatiniseret (majs-) stivelse, magnesiumstearat, Allura red AC (E129), Brilliant blue FCF (E133), titandioxid (E171), gul jernoxid (E172), gelatine, sort blæk
Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Dysfagi
Hepatobiliary disorders
Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med grøn, uigennemsigtig overdel og grøn, uigennemsigtig underdel, præget med “GR 4.5” på kapslens underdel med hvidt blæk.
Reagila 4.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Hård gelatinekapsel i str. 4 (ca. 14,3 mm lang) med hvid, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 1.5” på kapslens underdel med sort blæk.
Reagila 1.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Hård gelatinekapsel i str. 3 (ca. 15,9 mm lang) med lilla, uigennemsigtig overdel og hvid, uigennemsigtig underdel, præget med “GR 6” på kapslens underdel med sort blæk.
Reagila 6 mg hard capsules ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Odefsey indeholder tre aktive stoffer.
Odefsey contains three active substances.
Den fuldstændige EPAR for Odefsey findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Odefsey can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Odefsey.
This is a summary of the European public assessment report (EPAR) for Odefsey.
Dette betyder, at virkningerne af disse komponenter i Odefsey bør ligne virkningerne hos andre lægemidler.
This means that the effects of these components in Odefsey should be similar to their effects in other medicines.
Andre oplysninger om Odefsey
Other information about Odefsey
CHMP konkluderede derfor, at fordelene ved Odefsey opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The CHMP therefore decided that Odefsey's benefits are greater than its risks and recommended that it be approved for use in the EU.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Odefsey er en alternativ behandlingsform til Eviplera med lignende effektivitet.
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Odefsey is an alternative treatment option to Eviplera with similar effectiveness.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Odefsey?
What measures are being taken to ensure the safe and effective use of Odefsey?
Odefsey helbreder ikke hiv-1-infektion eller aids, men kan sinke den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids.
Odefsey does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Odefsey må ikke anvendes sammen med følgende lægemidler, da disse kan mindske blodets indhold af rilpivirin, så virkningen af Odefsey mindskes:
Odefsey must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Odefsey:
Ved at blokere dette enzym, mindsker Odefsey hiv-1mængden i blodet og holder den nede.
By blocking this enzyme, Odefsey reduces the amount of HIV-1 in the blood and keeps it at a low level.
• dexamethason (et kortikosteroid til behandling af betændelse og hæmning af immunsystemet), undtagen hvis det anvendes som engangsbehandling
• dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) except when used as a single dose treatment;
Odefsey er et antiviralt lægemiddel, der anvendes til behandling af voksne og unge (over 12 år med en vægt på mindst 35 kg), der er smittet med humant immundefektvirus type 1 (hiv-1), et virus der forårsager erhvervet immundefektsyndrom (aids).
Odefsey is an antiviral medicine used to treat adults and adolescents (aged over 12 years and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Det er ikke en praktisk vejledning i, hvordan Odefsey bør anvendes.
It is not intended to provide practical advice on how to use Odefsey.
Hvorfor blev Odefsey godkendt?
Why is Odefsey approved?
De tre aktivstoffer virker ved at blokere virussets enzym, revers transkriptase, der gør det muligt for hiv-1 at formere sig i de celler, det har smittet.
All three active substances block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Hvad er Odefsey, og hvad anvendes det til?
What is Odefsey and what is it used for?
For at understøtte anvendelsen af tenofoviralafenamid har virksomheden fremlagt data fra undersøgelser, der viser at kombinationslægemidler indeholdende tenofoviralafenamid er lige så effektive til at reducere mængden af hiv-1 i blodet som dem, der indeholder tenofovirdisoproxil.
To support the use of tenofovir alafenamide, the company provided data from studies showing that combination medicines containing tenofovir alafenamide are as effective in reducing the amount of HIV-1 in the blood as those containing tenofovir disoproxil.
Hvis du ønsker yderligere oplysninger om behandling med Odefsey, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Odefsey, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvad angår sikkerheden er tenofoviralafenamid effektiv ved en lavere dosis en tenofovirdisoproxil og kan føre til reducerede bivirkninger i nyrer og knogler.
In terms of safety, tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil and may lead to reduced side effects in the kidneys and bones.
Hvilke risici er der forbundet med Odefsey?
What are the risks associated with Odefsey?
Det anvendes kun til patienter, hvis virus ikke har udviklet resistens over for visse hiv-lægemidler kaldet non-nukleoside reverse transkriptasehæmmere (NNRTI), tenofovir eller emtricitabin, og hvis indhold af hiv i blodet højst er 100 000 hiv-1 RNA-kopier/ml.
It is only used in patients where the virus has not developed resistance to a class of HIV medicines called nonnucleoside reverse transcriptase inhibitors, tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
I tillæg hertil, for at understøtte ansøgningen, har virksomheden udført en bioækvivalensundersøgelse, hvor Odefsey blev sammenlignet med to andre hiv-lægemidler: Edurant (rilpivirin) og Genvoya (elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid).
In addition, to support its application, the company performed a ‘bioequivalence' study comparing Odefsey with two other HIV medicines: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide).
• rifabutin, rifampicin og rifapentin (antibiotika)
• rifabutin, rifampicin, rifapentine (antibiotics);
Almindelige bivirkninger ved rilpivirin kan også omfatte øget kolesterolniveau (samlet kolesterol og LDL-kolesterol), søvnløshed (søvnbesvær) og øget enzymniveau i lever og pankreas.
Very common side effects with rilpivirine also include increased cholesterol levels (total cholesterol and LDL-cholesterol), insomnia (difficulty sleeping) and increased liver and pancreas enzymes.
Odefsey fås som tabletter med et indhold af 200 mg emtricitabin, 25 mg rilpivirin og 25 mg tenofoviralafenamid.
Odefsey is available as tablets, each containing 200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide.
Meget almindelige bivirkninger ved aktivstoffet rilpivirin og kombinationen af emtricitabin og tenofoviralafenamid (som kan forekomme hos mere end én ud af 10 personer) er hovedpine, svimmelhed og kvalme (opkastning).
The most common side effects seen with the active substance rilpivirine and with the combination of emtricitabine and tenofovir alafenamide (which may affect more than 1 in 10 people) are headache, dizziness and nausea (feeling sick).
Dette forsøg viste, at Odefsey producerer de samme niveauer af rilpivirin i kroppen som Edurant, og de samme niveauer af emtricitabin og tenofoviralafenamid som Genvoya.
This study showed that Odefsey produces the same levels of rilpivirine in the body as Edurant, and the same levels of emtricitabine and tenofovir alafenamide as Genvoya.
Rilpivirin er et antiviralt middel, der også kaldes en nonnukleosid revers transkriptasehæmmer.
Rilpivirine is an antiviral agent called non-nucleoside reverse transcriptase inhibitor.
Hvis du ønsker praktisk vejledning om anvendelsen af Odefsey, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Odefsey, patients should read the package leaflet or contact their doctor or pharmacist.
Odefsey emtricitabin/rilpivirin/tenofoviralafenamid
Odefsey emtricitabine / rilpivirine / tenofovir alafenamide
I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Odefsey.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Odefsey have been included in the summary of product characteristics and the package leaflet.
Odefsey indeholder de aktive stoffer emtricitabin, rilpivirin og tenofoviralafenamid.
Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide.
• omeprazol, esomeprazol, dexlansoprazol, lansoprazol, pantoprazol, rabeprazol (lægemidler mod for meget mavesyre)
• omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole (medicines for reducing stomach acid);
Tenofovir og emtricitabin er beslægtede virusmidler af typen reverse transkriptasehæmmere.
Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Hvilke fordele viser undersøgelserne, at der er ved Odefsey?
What benefits of Odefsey have been shown in studies?
Hvordan virker Odefsey?
How does Odefsey work?
Hvordan anvendes Odefsey?
How is Odefsey used?
• perikum (et naturlægemiddel til behandling af depression og angst).
• St John's wort (a herbal preparation used for depression and anxiety).
Kombinationen af aktive stoffer i Odefsey (emtricitabin, rilpivirin og tenofovir) er allerede godkendt i EU som Eviplera til behandling af hiv-1-infektion.
The combination of active substances in Odefsey (emtricitabine, rilpivirine and tenofovir) is already approved in the EU as Eviplera to treat HIV-1 infection, although in Eviplera tenofovir is present as tenofovir disoproxil whereas in Odefsey it is present as tenofovir alafenamide.
50g 10 flasker
100 g 1 bottle
Der deltog i alt 692 patienter.
In total 692 patients were enrolled.
Sikkerheden kunne sammenlignes i de to grupper.
Safety was comparable between the groups.
Lettelse af symptomerne opnås hurtigt.
Relief of symptoms is obtained rapidly.
Individuel justering af dosis bør overvejes.
Individual adjustment of dosage should be considered.
Alle tre har et meget begrænset potentiale for lægemiddelinteraktion på CYP-niveau (Unge og Andersson 1997).
All three have a very limited potential for drug interactions at the CYP level (Unge and Andersson 1997).
De fremlagte bibliografiske data giver dokumentation til underbyggelse af indikationerne:
The bibliographic data submitted provide evidence to support the indications:
Sjældne (0,01-0,1%)
Rare (0.01-0.1%) Very Rare
Den samlede helingsrate var i følge Sakitas's klassifikation 95 %.
Overall rate of healing according to Sakitas classification was 95%.
Brugen af lansoprazol under graviditet anbefales derfor ikke.
Therefore, the use of lansoprazole during pregnancy is not recommended.
De begrænsede data for lansoprazol understøtter dette.
The limited data as regards lansoprazole support this.
Hvis symptomerne ikke er lettet inden for 4 uger med en daglig dosis på 30 mg, anbefales yderligere undersøgelser.
If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Der blev også foretaget endoskopi i uge 8.
Endoscopy was also performed at week 8.
Dyreundersøgelser indikerer ingen direkte skadelige virkninger med hensyn til graviditet, embryonal/føtal udvikling, barsel eller postnatal udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Reflux øsofagitis fremstår måske ikke som ulceration og/elle visuel beskadigelse, hvorfor i visse tilfælde endoskopi alene ikke er tilstrækkelig.
Reflux oesophagitis may not present as ulceration and/or visual damage, therefore in certain cases endoscopy alone may not be sufficient.
Efter 4 uger var de tilsvarende helingsrater 30 %, 47 % og 57 %.
At 4 weeks, the corresponding healing rates were 30%, 47% and 57%.
Det primære slutpunkt var recidiverende symptomatiske og komplicerede ulcera i løbet af de 8 uger.
The primary endpoint was recurrence of symptomatic and complicated ulcers during the 8 weeks.