natgillin/translations-raw huggingface dataset:
Maropitant udviser lineær kinetik ved subkutan indgivelse i dosisområdet 0,5-2 mg/kg.
Maropitant displays linear kinetics when administered subcutaneously within the 0.5-2 mg/kg dose range.
Efter behandlingen kan der hos hunde persistere tegn på kvalme, herunder stærkt spytflåd og letargi.
Signs of nausea in dogs including excessive salivation and lethargy might remain after treatment.
Det veterinære lægemiddel, injektionsvæske, opløsning, injiceres subkutant eller intravenøst én gang dagligt i en dosis på 1 mg maropitant/kg kropsvægt (1 ml/10 kg kropsvægt) i op til 5 på hinanden følgende dage.
The veterinary medicinal product solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant / kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days.
• Forebyggelse af opkastning bortset fra opkastning, der skyldes køresyge.
• For the prevention of vomiting except that induced by motion sickness.
EXP Skal anvendes senest 56 dage efter åbning.
EXP Once broached use within 56 days.
Den farmakokinetiske profil af maropitant ved indgivelse af en subkutan enkeltdosis på 1 mg/kg kropsvægt til hunde var karakteriseret af en maksimal plasmakoncentration (Cmax) på ca. 92 ng/ml.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Hos dyr med hjertesygdomme eller disposition for hjertesygdomme bør der udvises forsigtighed.
Prevomax should be used with caution in animals suffering from or with predisposition for heart diseases.
Den farmakokinetiske profil af maropitant ved indgivelse af en enkelt subkutan dosis på 1 mg/kg kropsvægt til katte var karakteriseret af en maksimalkoncentration (Cmax) i plasma på ca. 165 ng/ml.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to cats was characterised by a maximum concentration (Cmax) in plasma of approximately 165 ng/ml; this was achieved on average 0.32 hours (19 min) post-dosing (Tmax).
Terapeutiske indikationer, med angivelse af dyrearter, som lægemidlet er beregnet til
4.2 Indications for use, specifying the target species
Der synes at være en aldersrelateret sammenhæng med farmakokinetikken af maropitant hos katte, idet killinger har højere udskillelse end voksne katte.
The elimination t1/2 following intravenous dosing was approximately 4.9 h. There appears to be an age-related effect on the pharmacokinetics of maropitant in cats with kittens having higher clearance than adults.
VETERINÆRLÆGEMIDLETS NAVN Prevomax, 10 mg/ml, injektionsvæske
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml injection maropitant
Farmakokinetiske oplysninger
5.2 Pharmacokinetic particulars
INDLÆGSSEDDEL: Prevomax, 10 mg/ml, injektionsvæske, opløsning, til hunde og katte
PACKAGE LEAFLET: Prevomax 10 mg/ml solution for injection for dogs and cats
VETERINÆRLÆGEMIDLETS NAVN Prevomax, 10 mg/ml, injektionsvæske, opløsning, til hunde og katte maropitant
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats Maropitant
10. UDLØBSDATO EXP {måneder/år}
EXPIRY DATE EXP {month/year} Once broached use within 56 days.
Ved utilsigtet kontakt med øjnene skylles øjnene med rigeligt vand, og der søges læge.
Maropitant has been shown to be a potential eye irritant, and in the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
VETERINÆRLÆGEMIDLETS NAVN Prevomax, 10 mg/ml, injektionsvæske, opløsning, til hunde og katte
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats
Klar, farveløs til let gullig opløsning.
11.1 mg A clear, colourless to light yellow solution.
Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
Special precautions to be taken by the person administering the veterinary medicinal product to animals
månedligt i 13 måneder;
monthly for 13 months;
Der sås ingen forskelle i responsrater mellem de to doseringsgrupper.
There were no differences in response rates between the two dose groups.
Resultaterne er angivet i Tabel 5.
Results are provided in Table 5.
Derudover er der behandlet børn i 2 fase I undersøgelser og et fase II studie.
In addition, children have been treated in two phase I studies and one phase II study.
Følg omhyggeligt din læges anvisninger, selvom de er forskellige fra den generelle information i
Follow all your doctor's instructions carefully, even if they differ from the general information contained in
Optimal behandlingsvarighed er endnu ikke fastlagt.
Optimal treatment duration is not yet established.
2Cytogenetiske responskriterier:
2 Cytogenetic response criteria:
Der blev ikke observeret nogle fordele i den lave eller meget lave risikogruppe.
No benefit was observed in the low and very low risk groups.
* Fuldstændig opfølgningsperiode; IE - Ikke estimerbar
* Full follow-up period; NE - Not estimable
Disse associationer er dog ikke tilstrækkeligt udtalte til at udløse dosisjusteringer.
However, these associations are not sufficiently pronounced to warrant dose adjustment.
Hvis du ikke er i stand til at tage medicinen, som din læge har foreskrevet, eller hvis du føler, at du ikke længere behøver den, skal du kontakte din læge med det samme.
If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight
Den mediane overordnede overlevelse er endnu ikke nået.
The median overall survival has not been reached.
Patienter, der har lav eller meget lav risiko for tilbagefald, bør ikke få adjuverende behandling.
Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
Du må ikke åbne eller knuse kapslerne medmindre du ikke er i stand til at synke (for eksempel hos børn).
Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).
I de kliniske undersøgelser var 38-40% af patienterne ≥60 år, og 10-12% af patienterne var ≥70 år.
In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of
Der kan ikke drages nogle konklusioner for andre mindre almindelige mutationsundergrupper på grund af det lille antal observerede tilfælde.
No conclusions can be drawn for other less common mutation subgroups due to the low number of observed events.
Data fra mitotisk indeks var tilgængelige for 556 ud af 713 i intention-to-treat (ITT) gruppen.
Mitotic index data were available for 556 of the 713 intention-to-treat (ITT) population.
Resultaterne fra undergruppen-analysen, der blev vurderet ved risikoklassifikationer ifølge the United States National Institutes of Health (NIH) og the Armed Forces Institute of Pathology (AFIP), er vist i Tabel 6.
The results of subgroup analyses according to the United States National Institutes of Health (NIH) and the Armed Forces Institute of Pathology (AFIP) risk classifications are shown in Table 6.
Langtidseffekten af langvarig behandling med imatinib på væksten hos børn er ukendt.
The long-term effects of prolonged treatment with imatinib on growth in children are unknown.
Den aktuelle estimerede gennemsnitlige overlevelse hos tidligere ”ubehandlede” og ”behandlede patienter” var henholdsvis 7,7 og 4,7
The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Hvis det anvendes under graviditet, skal patienten informeres om den potentielle risiko for
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Translokationen t(17:22) [(q22:q13)], eller dets gen-produkt, var til stede i næsten alle respons på
The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Behandling med imatinib i 36 måneder var superior til behandling i 12 måneder i ITT-analysen, dvs. inklusive hele studiepopulationen.
Treatment with imatinib for 36 months was superior to treatment for 12 months in the ITT analysis, i.e. including the entire study population.
Tabel 5 Bedste tumorrespons i undersøgelse STIB2222 (GIST)
Table 5 Best tumour response in trial STIB2222 (GIST)
Leverfunktionen (transaminaser, bilirubin og alkalisk fosfatase) bør monitoreres jævnligt hos patienter
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Forsigtighed anbefales derfor, når der føres motorkøretøj eller
Therefore, caution should be recommended when driving a car
Prednisolon 200 mg oral, 5 dage per måned i 13 måneder Alle behandlingsregimer inkluderer administration af steroider mod CNS profylakse.
Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis.
Alle doser (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Der er ikke blevet observeret nogen fordel i total overlevelse.
No overall survival benefit has been observed.
dag 3-5;
days 3-5;
- Omrør med en ske, indtil tabletterne er opløst fuldstændig.
• Stir with a spoon until the tablets have completely dissolved.
Sikkerhedsdata fra dette studie synes at være i overensstemmelse med sikkerhedsprofilen for imatinib hos Ph+ ALL
Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
could cause hepatitis B to become active again, which can be fatal in some cases.
En betydelig gruppe patienter, som havde stabil sygdom ved interimsanalysen opnåede delvist respons med længere behandling (median opfølgningstid på 31 måneder).
A significant number of patients who had stable disease at the time of the interim analysis achieved a partial response with longer treatment (median follow-up 31 months).
Det er vigtigt, at du tager det så længe lægen eller apotekspersonalet fortæller dig, at du skal.
It is important that you do this as long as your doctor or pharmacist tells you to.
12 Gy i 8 fraktioner for alle patienter, som er CNS1 og CNS2 ved
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at
Effekt af seponering efter opnåelse af respons er ikke undersøgt.
The effect of stopping treatment after achieving a response has not been investigated.
Den gennemsnitlige absolutte biotilgængelighed for kapselformuleringen er 98%.
Mean absolute bioavailability for the capsule formulation is 98%.
Den opstår ved en ukontrolleret cellevækst af disse organers bindevæv.
It arises from uncontrolled cell growth of the supporting tissues of these organs.
Den totale koncentration af imatinib og metabolitten og spædbørns maksimale daglige indtagelse af mælk taget i betragtning forventes det, at den totale eksponering er lav (~10% af den terapeutiske dosis).
Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose).
For CML og GIST kan din læge foreskrive højere eller lavere dosis afhængigt af, hvordan du reagerer på behandlingen.
For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment.
Risikoen for tilbagefald hos patienter efter operation af deres primære GIST blev retrospektivt vurderet ud fra følgende prognostiske faktorer: tumorstørrelse, mitotisk indeks, tumorplacering.
The risk of recurrence in patients after surgery of their primary GIST was retrospectively assessed based on the following prognostic factors: tumour size, mitotic index, tumour location.
Ældre patienter: Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
Older people: Imatinib pharmacokinetics have not been specifically studied in older people.
Opdaterede oplysninger om 6 af disse 11 patienter, som er publiceret for nylig, viste, at alle disse patienter forblev i cytogenetisk remission (32-38 måneder).
In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32-38 months).
- Hvis du ikke er i stand til at synke kapslerne, kan du åbne dem og opløse pulveret i et glas
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of
Der er begrænset information om fordelingen af imatinib i human mælk.
There is limited information on imatinib distribution on human milk.
Tumorer skulle være målelige i mindst et sygdomsområde og responskarakterisering baseret på SWOG-kriterier (Southwestern Oncology Group).
Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Kapslens indhold er hvidt til lysegult granuleret pulver.
The content of the capsule is white to light yellow granulated powder.
F1-fertilitet var ikke påvirket, mens der sås et øget antal resorptioner og et nedsat antal levende fostre ved 45 mg/kg/dag.
F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
Eksponeringen er ca. 1,5- til 2- fold, svarende til en 1,5-gangs stigning af plasma AGP, som imatinib binder stærkt til.
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
På grund af studiets observationelle karakter var data for hæmatologisk, cytogenetisk og molekylær vurdering tilgængelige for henholdsvis 22, 9 og 17 af de 23 inkluderede patienter.
Due to the observational nature of this registry, haematologic, cytogenetic and molecular assessment data were available for 22, 9 and 17 of the 23 enrolled patients, respectively.
Sikkerhedsdatabasen for børn med Ph+ ALL er meget begrænset.
The safety database for children with Ph+ALL is very limited though no new safety
- Følelsesløse eller kolde tæer og fingre (tegn på Raynaud´s syndrom).
• Numb or cold toes and fingers (signs of Raynaud's syndrome).
Kliniske studier vedrørende adjuverende GIST
Clinical studies in adjuvant GIST
Disse patienter var i aldersgruppen 18-83 år og havde en patologisk diagnose af Kit-positiv malignt GIST, der var inoperabelt og/eller metastaserende.
These patients ranged in age from 18 to 83 years old and had a pathologic diagnosis of Kit-positive malignant GIST that was unresectable and/or metastatic.
Mediantiden til follow-up var 54 måneder (fra dato for randomisering til data cut-off) med i alt 83 måneder mellem den første randomiserede
The median time of follow-up was 54 months (from date of randomisation to data cut-off), with a total of 83 months between the first patient randomised and the cut-off date.
De første 37 patienter startede med 400 mg, protokollen blev efterfølgende ændret og tillod højere doser, hvorefter de resterende 223
The first 37 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 223 patients were started at 600 mg.
Mekanismen og betydningen for mennesker af disse resultater i karcinogenicitetsstudie hos rotter er
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet
36 måneders behandlingsarm % (CI)
36-month treatment arm % (CI)
• adjuverende behandling af voksne patienter, som har signifikant risiko for tilbagefald efter resektion af Kit (CD117)-positiv GIST.
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Plasma AUC for imatinib blev reduceret med 73% sammenlignet med patienter, som ikke blev behandlet med EIAEDs.
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Mens du tager Imatinib Teva B.V., vil din læge regelmæssigt kontrollere, om lægemidlet virker.
While you are taking Imatinib Teva B.V. your doctor will regularly check whether the medicine is working.
• voksne patienter med Ph+ CML i blastkrise.
• Adult patients with Ph+ CML in blast crisis.
Hovedparten af de pædiatriske patienter, der blev behandlet for GIST, manglede data, der bekræftede c-Kit eller PDGFR-mutationer, hvilket kan have ført til varierende kliniske udfald.
The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes.
Dosering hos børn bør baseres på legemsoverflade (mg/m2).
Dosing for children should be on the basis of body surface area (mg/m2).
Mælk/plasmaratio undersøgt i en enkelt patient blev bestemt til at være 0,5 for imatinib og 0,9 for metabolitten, hvilket tyder på en større udskillelse af metabolitten i mælk.
The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
- Pludselig hævelse og rødme af huden (tegn på en hudinfektion kaldet cellulitis).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
- Når tabletten er opløst, så drik hele glassets indhold med det samme.
• Once the tablet has dissolved, drink everything in the glass straight away.
Et hovedrespons kombinerer både fuldstændig og partiel respons: Fuldstændig (0% Ph+ metafaser), delvis (1-35%).
A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Der var i alt 397 patienter, der gav samtykke og blev randomiseret til studiet (199 patienter i 12 måneders armen og 198 patienter i 36 måneders armen), medianalderen var 61 år (interval fra 22 til 84 år).
There were a total of 397 patients consented and randomised to the study (199 patients on 12-month arm and 198 patients on 36-month arm), median age was 61 years (range 22 to 84 years).
Undersøgelse 0102 38 månedsdata Myeloid blastkrise (n=260) % patienter (CI95%)
Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Studiets primære endepunkt var recidivfri overlevelse (RFS), defineret som tiden fra randomisering til dato for tilbagefald eller død af enhver årsag.
The primary endpoint of the study was recurrence-free survival (RFS), defined as the time from date of randomisation to the date of recurrence or death from any cause.
Uventede, hurtige vægtstigninger bør undersøges nøje, og om nødvendigt bør understøttende terapi indledes og relevante indgreb foretages.
An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
På analysetidspunktet var behandlingsvarighedsmedianen 7 måneder (7 dage til 13 måneder).
At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months).
Elleve patienter opnåede hurtig CHR; hos 10 patienter var cytogenetiske abnormaliteter svundet fuldstændig, og der sås mindskning eller forsvinden af fusion-transcripts målt med RT-PCR.
Eleven patients achieved rapid CHR; ten had complete resolution of cytogenetic abnormalities and a decrease or disappearance of fusion transcripts as measured by RT-PCR.
Blastkrise defineres som ≥30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over
Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
RFS rater (%) 12 måneder 24 måneder Imatinib vs. placebo
RFS rates (%) 12 month 24 month Imatinib vs placebo
Ved en konservativ antagelse af at patienter med manglende data er ikkerespondenter, blev CHR observeret hos 20/23 (87%), CCyR hos 9/23 (39,1%) og MR hos 11/23 (47,8%) af patienterne.
When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
I denne patientpopulation kan levermetastaser potentielt medføre leverinsufficiens og nedsat metabolisme.
In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
De kan enten øge eller nedsætte virkningen af Imatinib Teva B.V., hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib Teva B.V.
They may increase or decrease the effect of Imatinib Teva B.V., either leading to increased side effects or making Imatinib Teva B.V. less effective.
Kvinder i den fertile alder skal tilrådes at anvende sikker kontraception under behandlingen.
Women of childbearing potential must be advised to use effective contraception during treatment.
- Øjensmerter eller svækkelse af dit syn, blødning i øjnene.
• Eye pain or deterioration in vision, bleeding in the eyes.
Hos voksne bør dosis reduceres fra 400 til 300 mg eller fra 600 til 400 mg, eller fra 800 mg til 600 mg, og hos børn fra 340 til 260 mg/m2/dag.
In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
6 doser)iii: dag 2, 3, 16, og 17
doses)iii: days 2, 3, 16, and 17
Som det var forventet på basis af studiedesignet, sås ingen forskel i varighed af remission, sygdomsfri overlevelse eller generel overlevelse, skønt patienter med komplet molekylær respons og forblivende i minimal residual sygdom havde større udbytte af behandlingen i form af både varighed af remission (p=0,01)
As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p=0.01) and disease-free survival (p=0.02).
Fald i albuminværdier forårsagede nedsat clearance (CL/f); og stigninger i leukocyttal forårsagede fald i Cl/f.
Decreased values of albumin caused a reduced clearance (CL/f); and higher levels of WBC led to a reduction of CL/f.
Behandling med imatinib kan seponeres eller dosis kan reduceres, som anbefalet i pkt.
Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section
Farmakoterapeutisk klassifikation: Protein-tyrosinkinasehæmmer, ATC-kode: L01XE01
Pharmacotherapeutic group: Protein kinase inhibitors, ATC code: L01XE01
Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med imatinib samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin.
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
På et år var den samlede RFS signifikant bedre for imatinib (97,7%) i forhold til placebo (82,3%), (p<0,0001).
At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Patienten bør testes for HBV-infektion før initiering af behandling med Imatinib Teva B.V.
Patients should be tested for HBV infection before initiating treatment with Imatinib Teva B.V.
Total-bilirubin: = 1,5 ULN ASAT: >ULN (kan være normal eller <ULN hvis total-bilirubin er >ULN)
Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Det totale antal dødsfald var 25 i 12 måneders behandlingsarmen og 12 i 36 måneders behandlingsarmen.
The total number of deaths were 25 for the 12-month treatment arm and 12 for the 36-month treatment arm.
Din læge har udskrevet Imatinib Teva B.V., fordi du lider af en alvorlig sygdom.
Your doctor has prescribed Imatinib Teva B.V. because you suffer from a serious condition.
Patienter, der blev inkluderet, havde en histologisk diagnose af primær GIST, udtrykt som Kit protein ved immunokemi og en tumorstørrelse på ≥3 cm med fuldstændig resektion af primær GIST inden for 14-70 dage før registrering i studiet.
Patients were included who had a histological diagnosis of primary GIST expressing Kit protein by immunochemistry and a tumour size ≥ 3 cm in maximum dimension, with complete gross resection of primary GIST within 14-70 days prior to registration.