natgillin/translations-raw huggingface dataset:
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 Infanrix Penta.
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 Infanrix Penta.
Dette betyder, at de aktive stoffer er bundet til aluminiumholdige forbindelser, hvorved reaktionen forstærkes.
This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
Valget af vaccine afhænger af de officielle anbefalinger.
The choice of which vaccine to use depends on official recommendations.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Infanrix Penta til GlaxoSmithKline Biologicals s.a. den 23. oktober 2000.
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s.a. on 23 October 2000.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Infanrix Penta.
This document is a summary of the European public assessment report (EPAR) for Infanrix Penta.
CHMP besluttede, at fordelene ved Infanrix Penta er større end risiciene, og anbefalede udstedelse af
The CHMP decided that Infanrix Penta's benefits are greater than its risks and recommended that it be
Markedsføringstilladelsen er gyldig på ubegrænset tid.
The marketing authorisation is valid for
Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, når personen udsættes for disse bakterier eller vira på naturlig vis.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Lægemidlet indeholder
It contains the following
Efter en måned havde mellem 86 og 100 % af børnene dannet beskyttende antistoffer mod alle de aktive stoffer i Infanrix Penta.
After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
Den vigtigste målestok for virkningen var dannelsen af antistoffer mod de aktive stoffer efter vaccination.
The main measure of effectiveness was the production of antibodies against the active substances after vaccination.
Undersøgelserne omfattede over 10 000 børn, hvoraf ca. tre fjerdedele fik Infanrix Penta i henhold til forskellige tidsplaner.
The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules.
Når barnet får vaccinen, opfatter immunsystemet delene af bakterier og vira som "fremmede" og producerer antistoffer mod dem.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
De hyppigste bivirkninger ved Infanrix Penta (som ses ved flere end 1 ud af 10 doser af vaccinen) er appetitløshed, feber på 38 ºC eller derover, hævelse, smerte og rødme på injektionsstedet, træthed, usædvanlig gråd, irritabilitet og rastløshed.
The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
• overfladeantigen (proteiner fra overfladen) af hepatitis B-virus,
• surface antigen (proteins from the surface) of the hepatitis B virus;
Efter boostervaccination sås en stigning i antallet af børn med beskyttende antistofniveauer mod de aktive stoffer.
After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
Infanrix Penta er også blevet undersøgt i ni undersøgelser af boostervaccination med deltagelse af over 4 000 børn, hvoraf 714 fik Infanrix Penta som booster.
Infanrix Penta has also been studied in nine studies of booster vaccination involving over 4,000 infants, 714 of whom received Infanrix Penta as a booster.
Infanrix Penta er blevet undersøgt i 16 undersøgelser af det primære vaccinationsforløb.
Infanrix Penta has been studied in 16 studies looking at the first course of vaccination.
Infanrix Penta kan gives til børn, der har fået en hepatitis B-vaccine ved fødslen.
Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth.
En boosterdosis af Infanrix Penta eller en tilsvarende vaccine skal gives mindst seks måneder efter den sidste dosis af primærvaccinationen.
A booster dose of Infanrix Penta or a similar vaccine must be given at least six months after the last dose of the initial course.
Infanrix Penta må ikke gives til børn, som tidligere har haft encephalopati (en hjernesygdom) som følge af en ukendt årsag inden for syv dage efter at have modtaget en vaccine indeholdende pertussiskomponenter.
Infanrix Penta must not be used in infants who have had encephalopathy (brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
• toxoider fra bakterien, der forårsager difteri og tetanus,
• toxoids from the bacteria that cause diphtheria and tetanus;
Infanrix Penta bør ikke gives til børn, der kan være overfølsomme (allergiske) over for nogle af de aktive stoffer, over for nogle af de øvrige indholdsstoffer i vaccinen eller over for neomycin og polymyxin (antibiotika).
Infanrix Penta should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics).
Det må ikke gives til børn, som tidligere har haft en allergisk reaktion efter at have modtaget en vaccine indeholdende difteri, tetanus, pertussis, hepatitis B eller polio.
It must not be used in infants who have had an allergic reaction after receiving a vaccine containing diphtheria, tetanus, pertussis, hepatitis B or polio in the past.
Undersøgelserne viste, at primærvaccination med Infanrix Penta medførte dannelse af beskyttende antistoffer.
The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies.
Injektionsstedet bør varieres ved hver injektion.
The site of injection should be alternated for subsequent injections.
Det anbefalede vaccinationsprogram for Infanrix Penta er to eller tre doser, som gives med mindst en måneds mellemrum, sædvanligvis inden barnet er seks måneder gammelt.
The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life.
Infanrix Penta er en kombination af komponenter, der har været tilgængelige i Den Europæiske Union (EU) i andre vacciner: difteri, tetanus, pertussis og hepatitis B indgik i Infanrix HepB fra 1997 til 2005, og difteri, tetanus, pertussis og poliovira indgår i andre vacciner.
Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines.
Hvis du ønsker yderligere oplysninger om behandling med Infanrix Penta, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte
For more information about treatment with Infanrix Penta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Infanrix Penta gives som en dyb injektion i en muskel.
Infanrix Penta is given by deep injection into a muscle.
difteri (D)-, tetanus (T)-, pertussis (acellulær, komponent) (PA)-, hepatitis B (rDNA) (HBV)-, poliomyelitis (inaktiveret) (IPV)-vaccine (adsorberet)
diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Den fuldstændige EPAR for Infanrix Penta findes her.
The full EPAR for Infanrix Penta can be found here.
• toxoider og andre proteiner oprenset fra B. pertussis,
• toxoids and other proteins purified from B. pertussis;
• toxoider (kemisk svækkede toksiner) fra difteri og tetanus, • dele af Bordetella pertussis (B. pertussis, en bakterie, der forårsager kighoste),
• toxoids (chemically weakened toxins) from diphtheria and tetanus; • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Infanrix Penta er en vaccine.
Infanrix Penta is a vaccine.
Hvilken risiko er der forbundet med Infanrix Penta?
What is the risk associated with Infanrix Penta?
Infanrix Penta anvendes til at beskytte børn under tre år mod difteri, tetanus (stivkrampe), pertussis (kighoste), hepatitis B og poliomyelitis (polio).
Infanrix Penta is used to protect infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and poliomyelitis (polio).
Infanrix Penta er en vaccine, der leveres som en suspension til injektion.
Infanrix Penta is a vaccine, which is available as a suspension for injection.
Den fuldstændige liste over alle de indberettede bivirkninger ved Infanrix Penta fremgår af indlægssedlen.
For the full list of all side effects reported with Infanrix Penta, see the package leaflet.
Infanrix Penta indeholder små mængder
Infanrix Penta contains small amounts of:
De produceres af en gærart, der har fået indsat et gen (dna), som sætter den i stand til at producere proteinerne.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Hvordan anvendes Infanrix Penta?
How is Infanrix Penta used?
Som ved alle vacciner er der risiko for apnø (korte pauser i vejrtrækningen), hvis Infanrix Penta gives til spædbørn, der er født meget for tidligt.
As for all vaccines, if Infanrix Penta is used in babies born very prematurely, there is a risk of them experiencing apnoea (brief pauses in breathing).
Hvilken fordel viser undersøgelserne, at der er ved Infanrix Penta?
What benefit has Infanrix Penta shown during the studies?
Vaccination med Infanrix Penta bør udskydes, hvis barnet får pludselig høj feber.
Infanrix Penta should be postponed in infants
- hvis du nogensinde har haft problemer med din lever.
- if you have ever had problems with your liver.
*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
1Kina, Hong Kong, Indonesien, Japan, Malaysia, Filippinerne, Singapore, Taiwan og Thailand.
1China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
31110 Noáin (Navarra) Spanien
31110 Noáin (Navarra) Spain
NR Ikke opnået (not reached).
NR Not reached.
I dette studie var sensibiliteten 43,1 % og specificiteten 100 %.
In that study, sensitivity was 43.1%, specificity was 100%.
Dette kan påvirke ca. 1 ud af 100 patienter, der tager gefitinib og kan være livstruende.
This may affect about 1 in 100 patients taking gefitinib and can be life-threatening.
• Du kan tage tabletten sammen med mad eller uden mad.
• You can take the tablet with or without food.
Disse lægemidler kan påvirke virkningen af dette lægemiddel.
These medicines may affect the way this medicine works.
Asiatisk etnisk oprindelse ekskluderer patienter af indisk herkomst og refererer til racen af patientgruppen og ikke nødvendigvis deres fødested.
d Asian ethnicity excludes patients of Indian origin and refers to the racial origin of a patient group and not necessarily their place of birth.
Allergiske reaktioner (1,1 %), inklusive angioødem og urticaria.
Allergic reactions (1.1%), including angioedema and urticaria.
Gefitinib Mylan må derfor ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
Gefitinib Mylan should not be used during pregnancy unless clearly necessary.
Tabletten tages sammen med eller uden mad på cirka det samme tidspunkt hver dag.
The tablet may be taken with or without food, at about the same time each day.
Gefitinib forlængede ikke overlevelsen hos den totale population.
Gefitinib did not prolong survival in the overall population.
Antal patienter, der kan evalueres ved livskvalitetsanalyser.
Number of patients evaluable for quality of life analyses.
LCS symptomforbedringsratea
LCS symptom improvement ratea
“m” er medianer angivet i måneder.
“m” is medians in months.
• Tag tabletten på ca. samme tidspunkt hver dag.
• Take the tablet at about the same time each day.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1321/001
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1321/001
- Warfarin (et såkaldt oralt antikoagulationsmiddel, til forebyggelse af blodpropper).
- Warfarin (a so-called oral anticoagulant, to prevent blood clots).
b “m” er medianer angivet i måneder.
b “m” is medians in months.
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)
Personer som aldrig har røget
Never smoker
NC Ikke udregnet (not calculated) for HR ved total overlevelse, fordi antal tilfælde er for lavt.
NC Not calculated for overall survival HR as the number of events is too few.
Ikke almindelig Hepatitis**
Uncommon Hepatitis**
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 post-marketed experience.
• Tag ikke antacida (for at mindske syre i din mave) 2 timer før og 1 time efter du tager Gefitinib
• Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking Gefitinib Mylan.
Tag ikke Gefitinib Mylan, hvis du ammer af hensyn til dit barns sikkerhed.
Do not take Gefitinib Mylan if you are breast-feeding for the safety of your baby.
Tag ikke Gefitinib Mylan: - hvis du er allergisk over for gefitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6).
Do not take Gefitinib Mylan: - if you are allergic to gefitinib or any of the other ingredients of this medicine (listed in section 6).
Kun robuste, pålidelige, sensitive test(s) med påvist anvendelighed til bestemmelse af EGFRmutationsstatus af tumorer eller ctDNA bør anvendes for at undgå falsk negative eller falsk positive bestemmelser (se pkt 5.1).
Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1).
N Objektive responsrater og 95 % CI for forskel mellem behandlingernea
N Objective response rates and 95% CI for difference between treatmentsa
Trial outcome index-resultater understøttede FACT-L- og LCS-resultaterne a
Trial outcome index results were supportive of FACT-L and LCS results a
Blisterpakningerne kan pakkes ind i aluminiumsposer.
The blisters may be packed into aluminium pouches.
117 Allée des Parcs 69800 Saint Priest Frankrig
117 Allée des Parcs 69800 Saint-Priest France
• Heftige hudreaktioner (sjælden) på store dele af kroppen.
• Severe skin reactions (rare) affecting large areas of your body.
Efter oral administration af C14-mærket gefitinib til diende rotter 14 dage post partum var koncentrationen af radioaktivitet i mælken 11 til 19 gange højere end i blodet.
Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Nogle lungeproblemer kan blive værre under behandling med Gefitinib Mylan.
Some lung problems may get worse during treatment with Gefitinib Mylan.
**Inkluderer isolerede rapporter om leversvigt, som i nogle tilfælde havde letalt udfald.
**This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
• Gastrointestinel perforation.
• Gastrointestinal perforation.
Gefitinib har et gennemsnitligt steady-state-volumen på 1400 l, hvilket tyder på, at der sker en omfattende distribution til væv.
Gefitinib has a mean steady-state volume of distribution of 1400 L indicating extensive distribution into tissue.
Cirka 8 % af patienterne havde en alvorlig bivirkning (common toxicity criteria (CTC), grad 3 eller 4).
Approximately 8% of patients had a severe ADR (common toxicity criteria, (CTC) grade 3 or 4).
Risikoen for dødelighed blandt patienter, der udviklede ILS, efter behandling med gefitinib eller kemoterapi, var højere hos patienter med følgende risikofaktorer:
Risk of mortality among patients who developed ILD on gefitinib or chemotherapy was higher in patients with the following risk factors:
Gefitinibresponsdata er mere sparsomme hos patienter, hvis tumorer indeholder mindre almindelige mutationer; de tilgængelige data tyder på, at G719X, L861Q og S7681 er sensibiliserende mutationer; og T790M alene eller exon 20-insertioner alene er resistensmekanismer.
Gefitinib response data is more sparse in patients whose tumours contain the less common mutations; the available data indicates that G719X, L861Q and S7681 are sensitising mutations; and T790M alone or exon 20 insertions alone are resistance mechanisms.
Bulløse tilstande, inklusive toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og erythema multiforme.
Bullous conditions including Toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme.
(CI) for total overlevelses-HR i den totale population, ellers 95 % konfidensinterval for HR c Konfidensinterval udelukkende under non-inferioritet-margen på 1,154
HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Behandling med Gefitinib Mylan skal initieres og superviseres af en læge med erfaring inden for cancer-behandling.
Treatment with Gefitinib Mylan should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Dispersionen kan også administreres gennem en naso-gastrisk sonde eller gastrostomisonde.
The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Virkningsmekanisme og farmakodynamisk virkning Den epidermale vækstfaktor (EGF) og dens receptor (EGFR [HER1; ErbB1]) er blevet identificeret som de vigtigste faktorer under cellevækst og proliferation for normale celler og cancerceller.
Mechanism of action and pharmacodynamic effects The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
• Rød eller øm mund.
• Red or sore mouth.
• Forhøjet mængde af stoffet kreatinin i en blodprøve (hænger sammen med nyrefunktionen).
• Increase of creatinine levels in a blood test (related to kidney function).
Det anbefales, at du undgår at blive gravid, og/eller at du ammer, mens du er i behandling med Gefitinib Mylan, fordi Gefitinib Mylan kan skade dit barn.
It is recommended that you avoid becoming pregnant during treatment with this medicine because Gefitinib Mylan could harm your baby.
• Blødning (såsom næseblod eller blod i urinen).
• Bleeding (such as nose bleed or blood in your urine).
Børn og unge Gefitinib Mylan er ikke beregnet til børn og teenagere under 18 år.
Children and adolescents Gefitinib Mylan is not indicated in children and adolescents under 18 years.
Lungecancer subskala.
LSC Lung cancer subscale.
Gefitinib udviser ingen enzym-induktionseffekter i dyreforsøg og ingen signifikant hæmning (in vitro) af nogen andre cytokrome P450-enzymer.
Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Gefitinib Mylan bruges til at behandle voksne med ikke-småcellet lungekræft.
Gefitinib Mylan is used to treat adults with non-small cell lung cancer.
• Svær åndenød eller pludselig forværring af åndenød, muligvis med hoste og feber.
• Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever.
Asymptomatisk stigning i kreatinin i blodprøver.
Asymptomatic laboratory elevations in blood creatinine.
Kontakt lægen eller apotekspersonalet, før du tager Gefitinib Mylan - hvis du nogensinde har haft andre problemer med lungerne.
Talk to your doctor or pharmacist before taking Gefitinib Mylan - if you have ever had any other lung problems.
28/70 (40 %) af de der aldrig har røget er M+.
28/70 (40%) of never smokers are M+.
Der sås en forøget relativ risiko for ILS hos patienter behandlet med gefitinib i forhold til kemoterapi i løbet af de første 4 ugers behandling (justeret OR 3,8; 95 % CI 1,9 til 7,7); derefter var den relative risiko lavere (justeret OR 2,5; 95 % CI 1,1 til 5,8).
An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
FACT-L QoLforbedringshyppigheda
FACT-L QoL improvement ratea
Hos den totale population blev der ikke observeret nogen statistisk signifikant forskel mellem gefitinib og docetaxel (75 mg/m²), målt som total overlevelse, progressionsfri overlevelse eller objektiv responsrate (se tabel 5).
In the overall population, no statistically significant difference between gefitinib and docetaxel (75 mg/m2) was observed for overall survival, progression free survival and objective response rates (see Table 5).
• Forøget antal leverenzymer, som kaldes alanin-aminotransferase, ved en blodprøve; hvis antallet er for højt, vil din læge muligvis fortælle dig, at du skal stoppe med at tage dette lægemiddel.
• Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, your doctor may tell you to stop taking this medicine.
• Hvis der er 12 timer eller mere til din næste dosis: Tag den glemte tablet, så snart du kommer i tanke om det.
• If it is 12 hours or more until your next dose: take the missed tablet as soon as you remember.
Fertilitet Kvinder i den fertile alder skal tilrådes ikke at blive gravide under behandlingen.
Women of childbearing potential Women of childbearing potential must be advised not to get pregnant during therapy.
Tabel 7 - Opsummering af multivariat logistisk regressionsanalyse for at identificere faktorer, som uafhængigt forudsiger tilstedeværelsen af EGFR-mutationer hos 786 kaukasiske patienter* Faktorer som forudsiger tilstedeværelse af EGFRmutation p-værdi
Table 7 - Summary of multivariate logistic regression analysis to identify factors that independently predicted for the presence of EGFR mutations in 786 Caucasian patients* Factors that predicted for presence of EGFR mutation p-value
I de fleste tilfælde er det i forbindelse med andre kendte risikofaktorer, f.eks. samtidig behandling med andre lægemidler såsom steroider eller NSAID, anamnese med gastrointestinal ulceration, alder, rygning, metastaser på perforationsstedet i tarmen.
In most cases this is associated with other known risk factors, including concomitant medicinal products such as steroids or NSAIDS, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
63/396 (16 %) af patienterne med adenokarcinom histologitype er M+.
63/396 (16%) of patients with adenocarcinoma histology are M+.
Tabel 2 - Sammenfatning af baseline mutationsstatus for tumor og ctDNA prøver for alle screenede patienter, hvor begge prøver var evaluerbare
Table 2 - Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
• Appetitmangel.
• Loss of appetite.
Tid til behandlingsstandsninga,b
Time to treatment failurea,b
<0,0001 4,4 gange højere hos dem med adenokarcinom end hos dem, der ikke har adenokarcinom
4.4 times higher in adenocarcinoma than in non-adenocarcinoma
• Tør mund.
• Dry mouth.
Tidligere behandlede patienter
Pre-treated patients