natgillin/translations-raw huggingface dataset:
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Slentrol opvejer risiciene til behandling af overvægt og fedme hos voksne hunde.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Slentrol excede the risks for the management of overweight and obesity in adult dogs and recommended that Slentrol be given a marketing authorisation.
Under behandlingen kan der forekomme opkastning, undertiden ledsaget af tegn på sløvhed, diarré eller blød afføring.
Vomiting, sometimes accompanied by signs of lethargy, diarrhoea or softened faeces may occur during treatment.
Slentrol indeholder det aktive stof dirlotapid, der anvendes som slankemiddel til hunde.
Slentrol contains the active substance dirlotapide which helps to reduce weight in dogs.
Efter disse første fire ugers behandling bør hunden vejes en gang om måneden, så længe den er i behandling med produktet.
Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment with the product and dose adjustments are made monthly according to the weight loss achieved.
Behandlingen kan også medføre nedsat ædelyst.
A reduced appetite may also occur during treatment.
Den fuldstændige liste over de indberettede bivirkninger for Slentrol fremgår af indlægssedlen.
For a full list of all side-effects reported with Slentrol, see the Package Leaflet.
Dette gælder f.eks. kolesterol- eller lidpidsænkende midler og lægemidler, der påvirker ædelyst og/eller kropsvægt, f.eks. langtidsvirkende glukokortikoider.
Certain medications, e.g. drugs that lower serum cholesterol or other serum lipids, or drugs that affect appetite and/or body weight, e.g. long-acting glucorticoids, were not permitted for use during the study.
Hvilken fordel viser undersøgelserne, at der er ved Slentrol?
What benefit has Slentrol shown during the studies?
Slentrol anvendes som slankemiddel til voksne hunde, der lider af overvægt eller fedme.
Slentrol is used in adult dogs that are overweight or obese, to help them lose weight.
Det fås som kapsler (5 mg, 20 mg, 100 mg, 140 mg, 180 mg og 250 mg).
It is available as capsules (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
Temozolomide Accord bør tages uden mad.
Temozolomide Accord should be taken without food.
Den fuldstændige EPAR for Temozolomide Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Temozolomide Accord can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
MTIC binder sig til DNA'et i cellerne, mens disse reproducerer sig selv, hvorved celledelingen standses.
MTIC binds to the DNA of cells while they are reproducing, which stops cell division.
Lægemidlets navn blev ændret til Temozolomide Accord den 27. maj 2015.
The name of the medicine was changed to Temozolomide Accord on 27 May 2015.
Dosis og antallet af doser afhænger af, hvilken type svulst der skal behandles, om patienten er blevet behandlet før, om Temozolomide Accord anvendes alene eller sammen med andre behandlinger og af, hvordan patienten responderer på behandlingen.
The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Accord is being used alone or with other treatments, and how the patient responds to treatment.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Temozolomide Hospira den 15. marts 2010.
The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hospira on 15 March 2010.
Temozolomide Accord anvendes alene hos disse patienter.
Temozolomide Accord is used on its own in these patients.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temozolomide Accord.
This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Accord.
Dosis af Temozolomide Accord afhænger af kropsoverfladen (beregnet ud fra patientens højde og vægt) og ligger på mellem 75 mg og 200 mg pr. kvadratmeter en gang dagligt.
The dose of Temozolomide Accord depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Temozolomide Accord skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temozolomide Accord.
Det betyder, at Temozolomide Accord er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
This means that Temozolomide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Hvis du ønsker yderligere oplysninger om behandling med Temozolomide Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Temozolomide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Temozolomide Accord bruges først sammen med strålebehandling og herefter alene.
Temozolomide Accord is used first with radiotherapy and then on its own;
1 Tidligere kaldet Temozolomide Hospira.
1 Previously known as Temozolomide Hospira.
Temozolomide Accord anvendes til behandling af ondartet gliom (svulster i hjernen) hos følgende patientgrupper:
Temozolomide Accord is used to treat malignant glioma (brain tumours) in the following groups of patients:
Det kan ligeledes være nødvendigt at give patienten et middel mod opkastninger inden indtagelsen af Temozolomide Accord.
Patients may also need to take medicines to prevent vomiting before taking Temozolomide Accord.
Temozolomide Accord er et ”generisk lægemiddel”.
Temozolomide Accord is a ‘generic medicine'.
Behandling med Temozolomide Accord skal ordineres af en læge, som har erfaring med behandling af hjernesvulster.
Treatment with Temozolomide Accord should be prescribed by a doctor with experience in the treatment of brain tumours.
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temozolomide Accord er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
The CHMP concluded that, in accordance with EU requirements, Temozolomide Accord has been shown to have comparable quality and to be bioequivalent to Temodal.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Temozolomide Accord.
The Committee recommended that Temozolomide Accord be given marketing authorisation.
Det aktive stof i Temozolomide Accord, temozolomid, tilhører en gruppe af lægemidler mod kræft kaldet alkylerende midler.
The active substance in Temozolomide Accord, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Temozolomide Accord er et lægemiddel mod kræft, der indeholder det aktive stof temozolomid.
Temozolomide Accord is a cancer medicine that contains the active substance temozolomide.
Da Temozolomide Accord er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Temozolomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Andre oplysninger om Temozolomide Accord
Other information about Temozolomide Accord:
Hvilke fordele og risici er der forbundet med Temozolomide Accord?
What are the benefit and risk of Temozolomide Accord?
Da Temozolomide Accord er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Temodal.
Because Temozolomide Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Hvorfor blev Temozolomide Accord godkendt?
Why has Temozolomide Accord been approved?
Hvordan blev Temozolomide Accord undersøgt?
How has Temozolomide Accord been studied?
Hvad er Temozolomide Accord?
What is Temozolomide Accord?
Hvad anvendes Temozolomide Accord til?
What is Temozolomide Accord used for?
Hvordan anvendes Temozolomide Accord?
How is Temozolomide Accord used?
Hvordan virker Temozolomide Accord?
How does Temozolomide Accord work?
Tid (uger)
Time (Weeks)
Disse tegn er anført under ”Alvorlige bivirkninger” i punkt 4.
Such signs are listed under “Serious side effects” in section 4.
Dato for første markedsføringstilladelse: 15. januar 2015 Dato for seneste fornyelse: 3. september 2019
Date of first authorisation: 15 January 2015 Date of latest renewal: 03 September 2019
Patienter skal monitoreres tæt.
Patients should be closely monitored.
Disse forbedringer blev opretholdt i 52 uger (studie 1 og 2).
These improvements were maintained for 52 weeks (studies 1 and 2).
Der blev ikke rapporteret tilfælde af mere svær neutropeni.
There were no reported cases of more severe neutropenia.
• hvis du har Crohns sygdom.
• if you have Crohn's disease.
Din læge vil beslutte, om og hvornår du kan genoptage behandlingen.
Your doctor will decide if and when you may restart the treatment.
PASI % ændring fra baseline
PASI % change from baseline
DAS28-CRP Uge 16
DAS28-CRP Week 16
De fleste af nedenstående bivirkninger er milde til moderate.
Most of the following side effects are mild to moderate.
CL var ikke afhængig af køn.
The CL was not impacted by gender.
Alle patienterne blev fulgt i op til 52 uger efter første administration af studiebehandlingen.
All patients were followed for up to 52 weeks following first administration of study treatment.
• hvis du har ulcerativ colitis.
• if you have ulcerative colitis.
For at forbedre sporbarheden af biologiske lægemidler skal navn og batchnummeret for det administrerede lægemiddel registreres tydeligt.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
For alle ovenstående indikationer tyder tilgængelige data på, at et klinisk respons sædvanligvis opnås inden for 16 ugers behandling.
For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment.
Antallet af PsA-patienter med aksial inddragelse var for lille til at muliggøre en meningsfuld vurdering.
The number of PsA patients with axial involvement was too small to allow meaningful assessment.
• Forsøg aldrig at genbruge din pen.
• Never try to reuse your pen.
9/l (CTCAE-grad 4) er blevet indberettet.
9/l (CTCAE grade 4) were reported.
• hvis du har langvarige eller gentagne infektioner.
• if you have long-term or repeated infections.
Lægen skal dog sikre passende opfølgning af patienterne.
However, the physician should ensure appropriate follow-up of patients.
Effekten af dette lægemiddel hos gravide kvinder er ikke kendt.
The effects of this medicine in pregnant women are not known.
hvis du har en aktiv infektion, som din læge mener er af betydning
• if you have an active infection which your doctor thinks is important.
Spinal mobilitet
Spinal mobility
Ud af disse blev mere end 11.700 patienter eksponeret for secukinumab i mindst et år.
Of these, over 11,700 patients were exposed to secukinumab for at least one year.
Patienter i disse studier havde haft diagnosen PsA i mindst fem år.
Patients in these studies had a diagnosis of PsA of at least five years.
På tværs af studier blev der beregnet absolutte biotilgængeligheder i området mellem 60 og 77 %.
Across studies, absolute bioavailabilities in the range between 60 and 77% were calculated.
Sikkerhedsprofilen for secukinumab er konsistent på tværs af alle indikationer.
The safety profile of secukinumab is consistent across all indications.
• hvis du på noget tidspunkt har haft en allergisk reaktion over for latex.
• if you have ever had an allergic reaction to latex.
• hvis du har tuberkulose.
• if you have tuberculosis.
Der blev påvist forbedringer i alle komponenter i ACR-scoren, inklusive patientvurdering af smerte.
Improvements were shown in all components of the ACR scores, including patient assessment of pain.
Disse forbedringer blev opretholdt til uge 52.
These improvements were sustained up to week 52.
Resultat (p-værdi versus placebo)
Outcome (p-value versus placebo)
I alle studier var det primære endepunkt American College of Rheumatology (ACR) 20-respons.
For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response.
Patienter, der blev randomiseret til ”behandling efter behov” opnåede ikke tilstrækkelig vedligeholdelse af effekten, og et fast månedligt vedligeholdelsesregime anbefales derfor.
Patients randomised to “retreatment as needed” did not achieve adequate maintenance of response and therefore a fixed monthly maintenance regimen is recommended.
Derudover vurderede et studie et kronisk behandlingsregime kontra et ”behandling efter behov”-regime [SCULPTURE].
In addition, one study assessed a chronic treatment regimen versus a “retreatment as needed” regimen [SCULPTURE].
Secukinumab kan potentielt øge risikoen for infektioner.
Secukinumab has the potential to increase the risk of infections.
• hvis du i øjeblikket har en infektion
• if you currently have an infection
ASAS 40-respons, % hsCRP, (post-BSL/BSL-ratio)
ASAS 40 response, % hsCRP, (post-BSL/BSL ratio)
Rører du ved dem, kan de måske blive aktiveret for tidligt.
By touching them, the syringe guard may be activated too early.
Det bør overvejes at seponere behandlingen hos patienter, der intet respons har vist efter 16 ugers behandling.
Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment.
Klargøringstiden fra gennembrydning af proppen til rekonstitution er afsluttet varer i gennemsnit 20 minutter og bør ikke overstige 90 minutter.
The preparation time from piercing the stopper until end of reconstitution takes 20 minutes on average and should not exceed 90 minutes.
Fortæl din læge, hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid.
Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Efter indledende ugentlig dosering i den første måned var tidsintervallet til opnåelse af maksimal koncentration på mellem 31 og 34 dage baseret på farmakokinetisk populationsanalyse.
After initial weekly dosing during the first month, time to reach the maximum concentration was between 31 and 34 days based on population pharmacokinetic analysis.
For begge studier var det primære endepunkt mindst 20 % forbedring i Assessment of Spondyloarthritis International Society (ASAS 20)-kriterier ved uge 16.
For both studies, the primary endpoint was at least a 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) criteria at week 16.
Cosentyx bør ikke bruges til børn og unge (under 18 år), da der ikke er gennemført studier for denne aldersgruppe.
Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not been studied in this age group.
Der er ikke gennemført studier på dyr for at vurdere det karcinogene potentiale for secukinumab.
Animal studies have not been conducted to evaluate the carcinogenic potential of secukinumab.
Patienter blev blindede for behandlingsregimet op til uge 52 og studiet fortsatte indtil uge 156.
Patients were blinded to the treatment regimen up to week 52, and the study continued to week 156.
• hvis du for nylig har fået eller skal have en vaccination.
• if you have recently had or are due to have a vaccination.
Det primære endepunkt var ASAS 20 ved uge 16.
The primary endpoint was ASAS 20 at week 16.
Nogle patienter, der til at begynde med udviser partielt respons, kan efterfølgende bedres med fortsat behandling ud over de 16 uger.
Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Statistisk signifikante forskelle i ACR20 versus placebo var opnået ved uge 3.
Statistically significant difference in ACR 20 versus placebo was reached at week 3.
Procentvist antal respondere
Percentage of responders
Der er ikke rapporteret om øget modtagelighed for tuberkulose fra kliniske studier.
No increased susceptibility to tuberculosis was reported from clinical studies.
Potentielt alvorlig infektion - tegnene kan være:
Possible serious infection - the signs may include:
Din læge vil holde øje med din tilstand for at kontrollere, at behandlingen virker, som den skal.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Data for uge 24 er vist i tabel 6.
Week 24 data are presented in Table 6.
• alvorlige allergiske reaktioner med shock (anafylaktisk reaktion)
• severe allergic reaction with shock (anaphylactic reaction)
Kun for omsorgspersoner og sundhedspersonale:
Caregivers and healthcare professionals only:
Clearance var dosis- og tidsuafhængig.
Clearance was dose- and time-independent.
ASAS partiel remission, %
ASAS partial remission, %
• hvis du modtager nogen anden form for behandling for psoriasis, eksempelvis en anden immunosuppressiv eller lysbehandling med ultraviolet lys (UV-lys).
• if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Secukinumab må dog ikke gives til patienter med aktiv tuberkulose.
However, secukinumab should not be given to patients with active tuberculosis.
Doser på op til 30 mg/kg (ca. 2.000 til 3.000 mg) er administreret intravenøst i kliniske studier uden dosisbegrænsende toksicitet.
Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity.
Hvis patienten udvikler en alvorlig infektion, skal patienten monitoreres tæt, og secukinumab må ikke administreres, før infektionen er ophørt.
If a patient develops a serious infection, the patient should be closely monitored and secukinumab should not be administered until the infection resolves.
Cosentyx er til langtidsbehandling.
Cosentyx is for long-term treatment.
Der foreligger ikke tilstrækkelige data om brugen af secukinumab hos gravide kvinder.
There are no adequate data from the use of secukinumab in pregnant women.
• hvis du er blevet vaccineret for nylig, eller hvis du skal have en vaccination under behandling med Cosentyx.
• if you have recently had a vaccination or if you are due to have a vaccination during treatment with Cosentyx.
Lignende respons blev set i PsA-studie 1.
Similar responses were seen in PsA study 1.
Brug ikke lægemidlet
Do not use this medicine:
Du vil evt. kunne se en lille luftboble, hvilket er helt normalt.
You may see a small air bubble, which is normal.
Virkningen af secukinumab på human fertilitet er ikke undersøgt.
The effect of secukinumab on human fertility has not been evaluated.
Klargøring af opløsningen til subkutan injektion skal udføres uden afbrydelse, og det skal sikres, at der anvendes aseptisk teknik.
The preparation of the solution for subcutaneous injection must be done without interruption and ensuring that aseptic technique is used.
Nedenstående oplysninger er til læger og sundhedspersonale.
The following information is intended for medical or healthcare professionals only.
Neutropeni<1,0-0,5x10
Neutropenia <1.0-0.5x10
Ældre patienter (65 år og derover) Dosisjustering er ikke påkrævet (se pkt.
Elderly patients (aged 65 years and over) No dose adjustment is required (see section 5.2).
Hvis du har glemt at indsprøjte en dosis Cosentyx, skal du indsprøjte den næste dosis, så snart du kommer i tanke om det.
If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember.
Over 61 % og 42 % af PsA-patienterne havde henholdsvis enthesitis eller dactylitis ved baseline.
Over 61% and 42% of the PsA patients had enthesitis and dactylitis at baseline, respectively.
Patienterne skal instrueres i at injicere den fulde mængde Cosentyx i henhold til de anvisninger, der er angivet i indlægssedlen.
Patients should be instructed to inject the full amount of Cosentyx according to the instructions provided in the package leaflet.
Alvorlig allergisk reaktion - tegnene kan være:
Serious allergic reaction - the signs may include:
Hvis du har fået mere Cosentyx, end du burde, eller hvis dosis er blevet givet tidligere end i henhold til din læges anvisning, skal du informere din læge.
If you have received more Cosentyx than you should or the dose has been administered sooner than according to your doctor's prescription, inform your doctor.
Hovedparten af IgG-elimination finder sted via intracellulær katabolisme efter væskefase eller receptormedieret endocytose.
The majority of IgG elimination occurs via intracellular catabolism, following fluid-phase or receptor mediated endocytosis.
Dyrestudier tyder ikke på direkte eller indirekte skadelige virkninger med hensyn til fertilitet.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Det er blevet påvist, at secukinumab sænker (inden for 1 til 2 ugers behandling) koncentrationen af C-reaktivt protein, som er en markør for inflammation.
Secukinumab has been shown to lower (within 1 to 2 weeks of treatment) levels of C-reactive protein, which is a marker of inflammation.
Efter brug af Cosentyx bør du ikke amme i mindst 20 uger efter sidste dosis.
After using Cosentyx you should not breast-feed for at least 20 weeks after the last dose.
Det er vigtigt, at du ikke forsøger at klare indsprøjtningen selv, før du er blevet undervist i at gøre det af din læge, sundhedspersonalet eller apotekspersonalet.
It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Legemsoverfladeareal (Body Surface Area)
ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Body Surface Area
Klinisk relevante niveauer af secukinumab når huden og reducerer lokale inflammatoriske markører.
Clinically relevant levels of secukinumab reach the skin and reduce local inflammatory markers.
Sjældne tilfælde af neutropeni <0,5x10
Rare cases of neutropenia <0.5x10
Dataene antyder, at secukinumab ikke undertrykker humoral immunrespons over for meningokok- og influenzavacciner.
The data suggest that secukinumab does not suppress the humoral immune response to the meningococcal or influenza vaccines.
• lavt blodtryk, som kan forårsage svimmelhed eller omtågethed
• low blood pressure, which can cause dizziness or light-headedness
Der er dokumenteret kemisk og fysisk stabilitet efter rekonstitution i 24 timer ved 2 ºC - 8 ºC.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2ºC to 8ºC.
Omkring halvdelen af de behandlingsfremkaldte antistoffer mod lægemidlet var neutraliserende, men dette blev ikke associeret med manglende virkning eller farmakokinetiske abnormaliteter.
About half of the treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of efficacy or pharmacokinetic abnormalities.
Forbedringer i HAQ-DIscore sås uanset tidligere eksponering for anti-TNFα.
Improvements in HAQ-DI scores were seen regardless of previous anti-TNFα exposure.
Procentdelen af patienter, der opnåede ACR20-respons som funktion af besøg, er vist i figur 2.
The percentage of patients achieving ACR 20 response by visit is shown in Figure 2.
Vindue, etiket og udløbsdato
Viewing window, label & expiry date
Tabel 6 Ændring i modificeret Total Sharp Score ved psoriasisartrit
Table 6 Change in modified Total Sharp Score in psoriatic arthritis