natgillin/translations-raw huggingface dataset:
• smerter i muskler, sener, ledbånd eller knogler
• muscle, tendon, ligament, bone pain,
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Risiko for svære fostermisdannelser Må ikke anvendes under graviditet eller amning Erivedge-programmet om svangerskabsforebyggelse skal overholdes
Do not use while pregnant or breast-feeding You must follow the Erivedge Pregnancy Prevention Programme
skællende hud, sår i mund, hals, næse, kønsorganer og øjne.
• Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes.
• Nødvendigheden af straks at kontakte lægen ved mistanke om graviditet hos en kvindelig partner, mens manden er i behandling og i 2 måneder efter behandling
• The need to contact the healthcare professional if the female partner suspects that she is pregnant while the patient is treated with Erivedge or in the 2 months following treatment
• hun skal anvende to metoder af anbefalet prævention (se afsnittet ”Prævention” nedenfor og pkt.
• She must use 2 methods of recommended contraception (see the ‘Contraception' section below and section 4.6) while she is taking Erivedge, unless she commits to not having sexual intercourse (abstinence),
• Sterilisering,
• Tubal sterilisation,
Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og CYP450-hæmmere forventes ikke.
Clinically significant PK interactions between vismodegib and CYP450 inhibitors are not expected.
1-års overlevelsesrate konfidensinterval)
1-year survival rate (95 % CI)
• Påminde patienter om ikke at donere blod under behandlingen og i 24 måneder efter sidste dosis
• Remind patients not to donate blood during treatment and for 24 months after the final dose
• Beskrivelse af huskekort til patienter
• Description of the patient reminder card
• Ingen bloddonation under behandling og i 24 måneder efter sidste dosis
• Not to donate blood during treatment and for 24 months after the final dose
Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og midler der hæver pH forventes ikke.
Clinically significant PK interactions between vismodegib and pH elevating agents are not expected.
• For tidlig indtræden af pubertet
• Premature puberty (precocious puberty)
• og især perikon (Hypericum perforatum) - et naturlægemiddel, som bruges til depression.
• St. John's wort (Hypericum perforatum) - a herbal medicine used for depression, since you must not use it at the same time as Erivedge.
• At patienten ikke må amme under behandlingen og i 24 måneder efter den sidste dosis
• That the patient should not breastfeed during treatment and for 24 months after their final dose
• Du skal aflevere alle ikke anvendte kapsler, når din behandling er afsluttet.
• At the end of your treatment you should return all unused capsules.
• kondom (om muligt med sæddræbende creme)
• a condom (with spermicide, if available)
Erivedge er kontraindiceret til fertile kvinder, der ikke overholder Erivedge-programmet for svangerskabsforebyggelse.
Counselling For a WCBP Erivedge is contraindicated in a WCBP who does not comply with the Erivedge Pregnancy Prevention Programme.
Kapslerne fås i beholdere med børnesikret låg med 28 stk. Hver pakning indeholder én beholder.
They are available in bottles with a child-resistant closure containing 28 capsules.
Vægttab Træthed Smerter
Weight decreased Fatigue
Denne type kræft ses oftest på solskadet hud.
Usually this type of lesion appears on sun-damaged skin, remains local and can be cured.
Tabel 2 SHH4476g-studiet.
Figure 2 SHH4476g Locally Advanced BCC Cohort
• Fertile kvinder, der ikke overholder Erivedge-programmet for svangerskabsforebyggelse (se pkt.
• Women of childbearing potential who do not comply with the Erivedge Pregnancy Prevention
Klinisk signifikante farmakokinetiske interaktioner mellem vismodegib og P-glykoprotein (P-gp)hæmmere forventes ikke.
Clinically significant PK interactions between vismodegib and P-gp inhibitors are not expected.
Det skal du vide, før du begynder at tage Erivedge Sådan skal du tage Erivedge
What Erivedge is and what it is used for What you need to know before you take Erivedge How to take Erivedge
Meget begrænset data er tilgængelig hos patienter med svært nedsat nyrefunktion.Patienter med svært nedsat nyrefunktion bør monitoreres omhyggeligt for bivirkninger.
Patients with severe renal impairment should be carefully monitored for adverse reactions.
Til mænd:
For men
• pessar (om muligt med sæddræbende creme).
• Diaphragm (with spermicide, if available).
• skal du fortsætte med at bruge prævention i 24 måneder efter din sidste dosis af medicinen
• you need to continue contraception for 24 months after your final dose of this medicine because Erivedge may remain in your body for up to 24 months after your final dose.
Hæmmere af hedgehog-signalveje (se pkt.
Hedgehog target genes.
Brug én meget sikker metode, som fx:
Use one highly effective method, such as: • a contraceptive depot injection
Rådgivning:
Responders
• At patienten ikke må være bloddonor under behandlingen og i 24 måneder efter den sidste dosis
• That the patient should not donate blood during treatment and for 24 months after their final dose
Erivedge-behandling
How to store Erivedge
Erivedge har været administreret i doser, der var 3,6 gange højere end den anbefalede daglige dosis på 150 mg. Der er i disse kliniske studier ikke set stigning i plasmakoncentrationen af vismodegib eller øget toksicitet.
Erivedge has been administered at doses 3.6 times higher than the recommended 150 mg daily dose.
Disse hændelser fortsatte i nogle tilfælde efter behandlingsstop grundet den lange elimineringshalveringstid.
Due to the long drug elimination half-life, these events may occur or progress after drug discontinuation.
Hvis du oplever nogle af symptomerne beskrevet i afsnit 4, skal du straks stoppe med at tage Erivedge og kontakte lægen.
Stop using Erivedge and seek medical attention immediately if you notice any of the symptoms described in section 4.
Til sundhedspersonalet:
For health care providers (HCP)
Der blev desuden observeret et fald i antal corpus luteum ved 100 mg/kg/dag i det generelle 26-ugers toksicitetsstudiet med vismodegib.
In addition, in the vismodegib general 26-week toxicity study, decreased number of corpora lutea was observed at 100 mg/kg/day; the effect was not reversed by the end of an 8 week recovery period.
basalcellekarcinom), og lægen har vurderet, at operation eller strålebehandling er uhensigtsmæssig.
• has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate.
Erivedge er indiceret til behandling af voksne patienter med: symptomatisk metastatisk basalcellekarcinom lokalt fremskredent basalcellekarcinom, hvor operation eller stråleterapi ikke er hensigtsmæssig (se pkt.
• locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).
• Kapslen indeholder: mikrokrystallinsk cellulose, lactosemonohydrat, natriumlaurilsulfat,
• Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate.
Indehaveren af markedsføringstilladelsen skal løbende sikre, at alle læger, som forventes at ordinere Erivedge, modtager følgende:
• Measures to ensure that all appropriate actions have been performed prior to Erivedge being prescribed and dispensed The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following: Product information Healthcare professional educational material Healthcare professional reminder card Patient educational material Patient reminder card The healthcare professional educational material for Erivedge should contain the following key elements:
• kløe
Myalgia
• Knogler stopper med at vokse
• Bones stop growing (epiphyses premature fusion)
• Huskekort til patienter
• Patient Reminder Card
• mavesmerter
Contraceptive steroids
• Leverskade
Asthenia
Hvordan virker Erivedge?
How Erivedge works
Låget er beklædt med voksbehandlet træpap, som er foret med aluminiumfolie.
The cap liner is aluminum foil-lined waxed pulp board.
Kutant planocellulært karcinom
Cutaneous squamous cell carcinoma (cuSCC)
Muskelspasmer Artralgi
Muscle spasms Arthralgia Pain in extremity
Hvis du tager Erivedge, kan det skade fostret eller slå fostret ihjel
This is because Erivedge may harm or cause the death of your unborn baby.
Lever og galdeveje
Flank pain
Actrapid indgives 30 minutter inden et måltid.
Actrapid is given 30 minutes before a meal.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Actrapid den 7. oktober 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid on 7 October 2002.
Den fuldstændige EPAR for Actrapid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Actrapid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Actrapid.
This is a summary of the European public assessment report (EPAR) for Actrapid.
Actrapid anvendes til behandling af diabetes.
Actrapid is used to treat diabetes.
EPAR - sammendrag for offentligheden human insulin
EPAR summary for the public human insulin
HbA1c-niveauerne holdt sig forholdsvis stabilt i løbet af den seks måneder lange behandlingsperiode med Actrapid.
HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
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 anvendelsesbetingelserne for Actrapid.
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 Actrapid.
Actrapid kan også indgives intravenøst (i en vene), men kun af en læge eller sygeplejerske.
Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
HbA1c viser, hvor godt blodsukkeret reguleres.
HbA1c gives an indication of how well the blood glucose is controlled.
Andre oplysninger om Actrapid:
Other information about Actrapid
Hvis du ønsker yderligere oplysninger om behandling med Actrapid, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Actrapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Actrapid blev undersøgt hos patienter med type 1-diabetes, hvor bugspytkirtlen ikke kan producere insulin (to undersøgelser, som omfattede 1954 patienter), eller type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt (en undersøgelse, som omfattede 182 patienter).
Actrapid has been studied in patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type 2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients).
CHMP besluttede, at fordelene ved Actrapid opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Actrapid.
The CHMP decided that Actrapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Erstatningsinsulinen fungerer på samme måde som naturligt produceret insulin og hjælper glukosen til at trænge ind i cellerne fra blodet.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
I undersøgelserne sammenlignede man over en periode på seks måneder Actrapid med en anden erstatningsinsulin kaldet insulin aspart ved at måle niveauet af glykosyleret hæmoglobin (HbA1c), som er den procentdel af hæmoglobin i blodet, der binder glukose til sig.
The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
De hyppigste bivirkninger ved Actrapid (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer).
The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (NovoLet, InnoLet eller FlexPen).
It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).
Actrapid er hurtigtvirkende insulin og kan anvendes sammen med mellemvirkende eller langtidsvirkende insulinpræparater.
Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins.
Hvilken risiko er der forbundet med Actrapid?
What is the risk associated with Actrapid?
Actrapid gives som injektion under huden i låret, bugvæggen (maveskindet), deltamuskelregionen (skulderen) ellr sædemuskelregionen (ballerne).
Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks).
Actrapid må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for human insulin eller andre af indholdsstofferne.
Actrapid must not be used in people who are hypersensitive to human insulin or any of the other ingredients.
Hvorfor blev Actrapid godkendt?
Why has Actrapid been approved?
Actrapid er en injektionsvæske, opløsning, som indeholder det aktive stof human insulin.
Actrapid is a solution for injection that contains the active substance human insulin.
Actrapid er et erstatningsinsulin, der er næsten identisk med det insulin, der produceres af bugspytkirtlen.
Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.
Den fuldstændige liste over indberettede bivirkninger ved Actrapid fremgår af indlægssedlen.
For the full description of all side effects reported with Actrapid, see the package leaflet.
Hvordan blev Actrapid undersøgt?
How has Actrapid been studied?
Hvilken fordel viser undersøgelserne, at der er ved Actrapid?
What benefit has Actrapid shown during the studies?
Hvad er Actrapid?
What is Actrapid?
Hvad anvendes Actrapid til?
What is Actrapid used for?
Hvordan anvendes Actrapid?
How is Actrapid used?
Insulinen er fremstillet af gær, der har modtaget et gen (DNA), som sætter den i stand til at producere insulin.
The active substance in Actrapid, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Hvordan virker Actrapid?
How does Actrapid work?
Æske med 6 flasker 24 timer
1 bottle 24 hours
Hunde: Ikke relevant
Cattle: 46 days Dogs: not applicable injection
EU/2/97/003/003 Dicural 100 mg Oral opløsning Kyllinger og kalkuner I drikkevand HDPE-flaske 1000 ml
Bottle (HDPE) 1,000 ml Pack of 6 bottles
Kvæg: 46 dage
24 hours
Dette kan tage op til 20 minutter.
This may take up to 20 minutes.
- hvis du nogensinde har haft problemer med din lever.
if you have ever had problems with your liver.
Kina, Hong Kong, Indonesien, Japan, Malaysia, Filippinerne, Singapore, Taiwan og Thailand
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Den potentielle risiko hos mennesker er ikke kendt.
The potential risk for humans is unknown.
En opdateret RMP skal fremsendes:
An updated RMP shall be submitted:
Dato for første markedsføringstilladelse: 24/06/2009 Dato for seneste fornyelse: 23/04/2014
Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
* fra følgende studier: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
*from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Drik væsken med det samme.
Drink the liquid straight away.
IRESSA forlængede ikke overlevelsen hos den totale population.
IRESSA did not prolong survival in the overall population.
ORR var i henhold til investigators gennemgang 70 % og median-PFS var 9,7 måneder.
The ORR according to investigator review was 70% and the median PFS was 9.7 months.
LCS symptomforbedringsrate
LCS symptom improvement rate
Disse data er i overensstemmelse med den planlagte eksploratoriske japanske subgruppeanalyse i IPASS (Goto 2012).
These data are consistent with the pre-planned exploratory Japanese subgroup analysis in IPASS (Goto 2012).
Dette kan ramme cirka 1 ud af 100 patienter, som tager IRESSA, og kan være livstruende.
This may affect about 1 in 100 patients taking IRESSA and can be life-threatening.
Dette protein er involveret i vækst og spredning af kræftceller.
This protein is involved in the growth and spread of cancer cells.
IRESSA må derfor ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
IRESSA should not be used during pregnancy unless clearly necessary.
Allergiske reaktioner (1,1 %), inklusive angioødem og urticaria
Allergic reactions (1.1%), including angioedema and urticaria
HR Hazard ratio (hazard ratio <1 favoriserer IRESSA)
HR Hazard ratio (hazard ratios <1 favour IRESSA)
Disse data svarer til dem, der blev rapporteret i IPASS-studiet.
These data are similar to those reported in the IPASS study.
Ingen af patienterne led af cancer, alle led af cirrose, og nogle havde hepatitis.
None of the patients had cancer, all had cirrhosis and some had hepatitis.
Læberne, næsen, øjnene og kønsorganerne kan også være påvirkede.
The lips, nose, eyes and genitals may also be affected.
Denne bivirkning er ikke almindelig, men nogle patienter er døde af den.
This side effect is uncommon; however, some patients have died from this.
Plasma-proteinbindingen er ca. 90 %.
Plasma protein binding is approximately 90%.
Derfor anbefales periodisk kontrol af leverfunktionen.
Therefore, periodic liver function testing is recommended.
Der er ingen data for anvendelse af gefitinib hos gravide kvinder.
There are no data from the use of gefitinib in pregnant women.
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines this medicine can cause side effects, although not everybody gets them.
b ”m” er medianer i måneder.
b “m” is medians in months.
Fortæl hurtigst muligt din læge, hvis du lægger mærke til en af følgende bivirkninger:
Tell your doctor as soon as possible if you notice any of the following side effects:
• Tag ikke antacida (for at mindske syre i din mave) 2 timer før og 1 time efter du tager IRESSA.
Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA.
Hvis en dosis glemmes, skal den tages, så snart patienten husker det.
If a dose is missed, it should be taken as soon as the patient remembers.
Samlet resumé af sikkerhedsprofilen
Summary of the safety profile
Andre potentielle interaktioner
Other potential interactions
I dette studie var sensibiliteten 43,1 % og specificiteten 100 %.
In that study, sensitivity was 43.1%, specificity was
Gefitinib udviste ikke genotoksisk potentiale.
Gefitinib showed no genotoxic potential.
Frekvenser for forekomsten af bivirkninger er defineret som: Meget almindelige (≥ 1/10); almindelige (≥ 1/100 til < 1/10); ikke almindelige (≥ 1/1.000 til < 1/100); sjældne (≥ 1/10.000 til < 1/1.000); meget sjældne (< 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Hvis du tager et lægemiddel, der indeholder dette aktive stof, kan det være, at din læge vil tage blodprøver oftere end normalt.
If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.
Glasset skal svinges forsigtigt rundt af og til, indtil tabletten er opslæmmet (det kan tage op til 20 minutter).
The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes).
Det bør overvejes at afbryde behandlingen, hvis ændringerne er alvorlige.
Discontinuation should be considered if changes are severe.
Bivirkningerne forekommer normalt inden for den første måned af behandlingen og er generelt reversible.
ADRs usually occur within the first month of therapy and are generally reversible.
Ikke-justeretanalyse PP population for kliniske faktorer ITT population for biomarkøre faktorer
Unadjusted analysis PP population for clinical factors ITT population for biomarker factors
Tabletten tages oralt sammen med eller uden mad på cirka det samme tidspunkt hver dag.
The tablet may be taken orally with or without food, at about the same time each day.
Ikke-justeretanalyse EFR population
Unadjusted analysis EFR population
Blisterfolien kan være perforeret eller ikkeperforeret.
The blister foil may be perforated or non-perforated.
9.8 v. 13.1 Kvinder
9.8 v. 13.1 Female
Patienter, der oplever dette symptom, bør derfor være forsigtige, når de fører motorkøretøj eller betjener maskiner.
Therefore, patients who experience this symptom should be cautious when driving or using machines.
• Tag tabletten på ca. samme tidspunkt hver dag.
Take the tablet at about the same time each day.
Trial outcome index-resultater understøttede FACT-L- og LCS-resultaterne.
Trial outcome index results were supportive of FACT-L and LCS results
Opslæmningen skal drikkes umiddelbart herefter (dvs. inden for 60 minutter).
The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Der er ingen specifik behandling i tilfælde af overdosering af gefitinib.
There is no specific treatment in the event of overdose of gefitinib.
• Du kan tage tabletten sammen med mad eller uden mad.
You can take the tablet with or without food.
Behandling med IRESSA skal initieres og superviseres af en læge med erfaring inden for cancerbehandling.
Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
- Warfarin (et såkaldt oralt antikoagulationsmiddel, til forebyggelse af blodpropper).
Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Positiv indikator (9,5 % af den totale population har positiv EGFR-mutation (M+))
Positive predictive value (9.5% of the overall population are EGFR mutation-positive (M+))
Tag ikke IRESSA hvis du ammer af hensyn til dit barns sikkerhed.
Do not take IRESSA if you are breast-feeding for the safety of your baby.
Brug ikke andre væsker.
Do not use any other liquids.
Figur 1 og 2 Data for virkning i undergrupper af ikke-asiatiske patienter i INTEREST-studiet (N patienter = antal randomiserede patienter)
Figures 1 and 2 Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Disse patienter skal monitoreres tæt for bivirkninger.
These patients should be closely monitored for adverse events.
FACT-L QoLforbedringshyppighed
N FACT-L QoL improvement rate
Knus ikke tabletten.
Do not crush the tablet.
Sikkerhedsprofilen, som fremgår af Tabel 1, er baseret på det kliniske udviklingsprogram med gefitinib og postmarketing-erfaringer.
The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
Fortæl det straks til din læge, hvis du oplever en af følgende bivirkninger - det kan være, du behøver akut medicinsk behandling:
Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:
Kvinder i den fertile alder skal tilrådes ikke at blive gravide under behandlingen.
Women of childbearing potential must be advised not to get pregnant during therapy.
N Antal randomiserede patienter.
N Number of patients randomised.
AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA Storbritannien
AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom