natgillin/translations-raw huggingface dataset:
Efter oral administration af den kraftige CYP2C8-hæmmer gemfibrozil (600 mg to gange dagligt) til raske mandlige forsøgspersoner blev AUC for enzalutamid forøget med 326 %, mens Cmax for enzalutamid faldt med 18 %.
Following oral administration of the strong CYP2C8 inhibitor gemfibrozil (600 mg twice daily) to healthy male subjects, the AUC of enzalutamide increased by 326% while Cmax of enzalutamide decreased by 18%.
Median PFS var 15,7 måneder for patienter behandlet med enzalutamid mod 5,8 måneder for patienter behandlet med bicalutamid [HR = 0,44 (95 % KI: 0,34; 0,57), p < 0,0001].
Median PFS was 15.7 months for patients on enzalutamide versus 5.8 months for patients on bicalutamide [HR = 0.44 (95% CI: 0.34, 0.57), p < 0.0001].
Der er imidlertid observeret en længere halveringstid for enzalutamid hos patienter med svært nedsat leverfunktion (se pkt.
An increased half-life of enzalutamide has however been observed in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Brug af enzalutamid har været forbundet med krampeanfald (se pkt.
Use of enzalutamide has been associated with seizure (see section 4.8).
Xtandi 40 mg filmovertrukne tabletter er gule, runde, filmovertrukne tabletter, præget med E 40.
Xtandi 40 mg film-coated tablets are yellow round film-coated tablets, debossed with E 40.
Figur 7: Kaplan-Meier-kurver for samlet overlevelse i AFFIRM-studiet (intent-to-treat-analyse)
Figure 7: Kaplan-Meier curves of overall survival in the AFFIRM study (intent-to-treat analysis)
5.2) kan virkninger på enzymer vare ved i en måned eller mere efter standsning af behandlingen med enzalutamid.
In consideration of the long half-life of enzalutamide (5.8 days, see section 5.2), effects on enzymes may persist for one month or longer after stopping enzalutamide.
Enzalutamid viste en statistisk signifikant reduktion på 71 % i den relative risiko for radiografisk progression eller død sammenlignet med placebo [HR = 0,29 (95 % KI: 0,24, 0,35), p < 0,0001].
Enzalutamide demonstrated a statistically significant 71% reduction in the relative risk of radiographic progression or death compared to placebo [HR = 0.29 (95% CI: 0.24, 0.35), p < 0.0001].
Blod og lymfesystem Ikke almindelig: Leukopeni, neutropeni Ikke kendt*: Trombocytopeni
Uncommon: leucopenia, neutropenia Not known*: thrombocytopenia
Xtandi 40 mg bløde kapsler enzalutamid
Xtandi 40 mg soft capsules enzalutamide
Spørg lægen, hvis der er noget, du er i tvivl om.
Check with your doctor if you are not sure.
Mediantiden indtil første skeletrelaterede hændelse var 16,7 måneder for patienter behandlet med enzalutamid og 13,3 måneder for patienter, som modtog placebo [HR = 0,69 (95 % KI: 0,57, 0,84), p <0,0001].
The median time to first skeletal-related event was 16.7 months for patients treated with enzalutamide and 13.3 months for patients who received placebo [HR = 0.69 (95% CI: 0.57, 0.84), p < 0.0001].
I det kliniske studie MDV3100-009 (STRIVE) af ikke-metastatisk og metastatisk CRPC, viste patienter, der fik enzalutamid, en signifikant højere total bekræftet PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik bicalutamid, 81,3 % versus 31,3 % (forskel = 50,0 %, p < 0,0001).
In the MDV3100-09 clinical trial (STRIVE) of non-metastatic and metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher total confirmed PSA response rate (defined as a ≥ 50% reduction from baseline) compared with patients receiving bicalutamide, 81.3% versus 31.3% (difference = 50.0%, p < 0.0001).
I et klinisk fase 2-studie (TERRAIN) med kemoterapi-naive patienter viste patienter, der fik enzalutamid, en signifikant højere total PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik bicalutamid, 82,1 % versus 20,9 % (forskel = 61,2 %, p < 0,0001).
In a phase 2 clinical trial (TERRAIN) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving bicalutamide, 82.1% versus 20.9% (difference = 61.2%, p < 0.0001)
Meget almindelig: Frakturer‡ Ikke kendt*: Myalgi, muskelkramper, muskelsvaghed, rygsmerter
Not known*: myalgia, muscle spasms, muscular weakness, back pain
Figur 6: Kaplan-Meier-kurver over radiografisk progressionsfri overlevelse i PREVAIL-studiet (intent-to-treat-analyse)
Figure 6: Kaplan-Meier curves of radiographic progression-free survival in the PREVAIL study (intent-to-treat analysis)
For summen af ubundet enzalutamid plus den ubundne aktive metabolit steg AUC og Cmax hos forsøgspersoner med let nedsat leverfunktion med henholdsvis 14 % og 19 %, og AUC hos forsøgspersoner med moderat nedsat leverfunktion steg med 14 %, mens Cmax faldt med 17 %.
For the sum of unbound enzalutamide plus the unbound active metabolite, the AUC and Cmax in subjects with mild impairment increased by 14% and 19%, respectively, the AUC and Cmax in subjects with moderate impairment increased by 14% and decreased by 17%, respectively, and the AUC and Cmax in subjects with severe hepatic impairment increased by 34% and decreased by 27%, respectively, compared to healthy control subjects.
Dette omfatter visse former for medicin, som anvendes til: sænkning af kolesterol (f.eks. gemfibrozil, atorvastatin, simvastatin) smertebehandling (f.eks. fentanyl, tramadol) kræftbehandling (f.eks. cabazitaxel) epilepsibehandling (f.eks. carbamazepin, clonazepam, phenytoin, primidon, valproinsyre) behandling af visse psykiatriske lidelser, som f.eks. svær angst eller skizofreni (f.eks. diazepam, midazolam, haloperidol)
This includes certain medicines used to: - Lower cholesterol (e.g. gemfibrozil, atorvastatin, simvastatin) - Treat pain (e.g. fentanyl, tramadol) - Treat cancer (e.g. cabazitaxel) - Treat epilepsy (e.g. carbamazepine, clonazepam, phenytoin, primidone, valproic acid) - Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam,
I det kliniske studie MDV3100-14 (PROSPER) af ikke-metastatisk CRPC, viste patienter, der fik enzalutamid, en signifikant højere bekræftet PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik placebo, 76,3 % versus 2,4 % (forskel = 73,9 %, p
In the MDV3100-14 clinical trial (PROSPER) of non-metastatic CRPC, patients receiving enzalutamide demonstrated a significantly higher confirmed PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 76.3% versus 2.4% (difference = 73.9%, p < 0.0001).
Hver blød kapsel indeholder 40 mg enzalutamid.
Each soft capsule contains 40 mg of enzalutamide.
Medianoverlevelse (måneder) (95 % KI)
Deaths (%) Median survival (months) (95% CI)
Tid til første brug af ny antineoplastisk behandling Antal hændelser ( %)
Time to first use of new antineoplastic therapy
Tal med lægen, inden du tager Xtandi hvis du tager medicin til forebyggelse af blodpropper (f.eks. warfarin, acenocoumarol, clopidogrel) hvis du får kemoterapi som f.eks. docetaxel hvis du har leverproblemer hvis du har nyreproblemer
Talk to your doctor before taking Xtandi - If you are taking any medicines to prevent blood clots (e.g. warfarin, acenocoumarol,
Kontakt lægen, før du tager dette lægemiddel, hvis noget af ovenstående gælder for dig, eller hvis du er usikker.
If any of the above applies to you or you are not sure, talk to your doctor before taking this medicine.
Tabletterne må ikke deles, knuses eller tygges, før de synkes.
- Do not cut, crush or chew the tablets before swallowing.
UTILGÆNGELIGT FOR BØRN
Children and adolescents
Sådan skal du tage Xtandi
How to take Xtandi
Enzalutamid opløses ikke nemt i vand.
Enzalutamide is poorly water soluble.
Der er observeret overfølsomhedsreaktioner med enzalutamid, som viser sig ved symptomer, der omfatter, men ikke er begrænset til, udslæt eller ansigts-, tunge-, læbe- eller faryngealt ødem (se pkt.
Hypersensitivity reactions manifested by symptoms including, but not limited to, rash, or face, tongue, lip, or pharyngeal oedema, have been observed with enzalutamide (see section 4.8).
Xtandi - 80 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder indeholder 80 mg enzalutamid.
Xtandi - 80 mg film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide.
Mediantiden til PSA-progression ifølge PCWG2-kriterier var 11,2 måneder for patienter behandlet med enzalutamid og 2,8 måneder for patienter, der fik placebo [HR = 0,17 (95 % KI: 0,15, 0,20), p < 0,0001].
The median time to PSA progression per PCWG2 criteria was 11.2 months for patients treated with enzalutamide and 2.8 months for patients who received placebo [HR = 0.17 (95% CI: 0.15, 0.20), p < 0.0001].
EVENTUELLE ANDRE SÆRLIGE ADVARSLER 8.
OTHER SPECIAL WARNING(S), IF NECESSARY
Enzalutamid er en stærk enzyminduktor og øger syntesen af mange enzymer og transportører.
Enzalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Ved samtidig administration har enzalutamid ingen klinisk relevant effekt på farmakokinetikken af intravenøs docetaxel (se pkt.
Co-administration of enzalutamide has no clinically relevant effect on the pharmacokinetics of intravenous docetaxel (see section 4.5); however, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded.
Xtandi - 40 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 40 mg enzalutamid.
Xtandi - 40 mg film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide.
Hver Xtandi 40 mg filmovertrukken tablet indeholder 40 mg enzalutamid.
Each Xtandi 40 mg film-coated tablet contains 40 mg of enzalutamide.
Kvindelige omsorgspersoner henvises til punkt 3 "Sådan skal du tage Xtandi" vedrørende håndtering og brug.
If you are having sex with a pregnant woman, use a condom to protect the unborn child. - Female caregivers see section 3 ‘How to take Xtandi' for handling and use.
CYP2C8 og i mindre grad af CYP3A4/5 (se pkt.
Enzalutamide is metabolised by CYP2C8 and to a lesser extent by CYP3A4/5 (see section 4.5), both of which play a role in the formation of the active metabolite.
• Protonpumpehæmmer (f.eks. omeprazol)
• Proton pump inhibitor (e.g. omeprazole)
LÆGEMIDLETS NAVN Xtandi 80 mg
Xtandi 80 mg
De bløde kapsler må ikke tygges, opløses eller åbnes, før de synkes.
- Do not chew, dissolve or open the soft capsules before swallowing.
Xtandi - 40 mg filmovertrukne tabletter Gule, runde - filmovertrukne tabletter, præget med E 40.
Xtandi - 40 mg film-coated tablets Yellow round - film-coated tablets, debossed with E 40.
• Hjerteglykosider (f.eks. digoxin)
• Cardiac glycosides (e.g. digoxin)
I et andet klinisk fase 3-studie (PREVAIL) med kemoterapi-naive patienter viste patienter, der fik enzalutamid, en signifikant højere total PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik placebo, 78,0 % versus 3,5 % (forskel = 74,5 %, p < 0,0001).
In another phase 3 clinical trial (PREVAIL) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Hver Xtandi 80 mg filmovertrukken tablet indeholder 80 mg enzalutamid..
Each Xtandi 80 mg film-coated tablet contains 80 mg of enzalutamide.
Sådan virker Xtandi
How Xtandi works
Mediantiden til initiering af cytotoksisk kemoterapi var 28,0 måneder for patienter, der fik enzalutamid, og 10,8 måneder for patienter, der fik placebo [HR = 0,35 (95 % KI: 0,30, 0,40), p <
The median time to initiation of cytotoxic chemotherapy was 28.0 months for patients receiving enzalutamide and 10.8 months for patients receiving placebo [HR = 0.35 (95% CI: 0.30, 0.40), p < 0.0001].
Figur 3: Kaplan-Meier-kurver for progressionsfri overlevelse i STRIVE-studiet (intent-to-treatanalyse)
Figure 3: Kaplan-Meier Curves of progression-free survival in the STRIVE study (intent-totreat analysis)
Figur 1: Kaplan-Meier-kurver for metastasefri overlevelse i PROSPER-studiet (intent-to-treatanalyse)
Figure 1: Kaplan-Meier Curves of metastasis-free survival in the PROSPER study (intent-totreat analysis)
40 mg filmovertrukne tabletter
40 mg film-coated tablets
Meget almindelig: Asteni, træthed behandlingskomplikationer Almindelig: Fald
Very common: asthenia, fatigue
Česká republika Astellas Pharma s.r.o.
Astellas Pharma s.r.o.
Indholdsstoffer i den bløde kapselskal: Gelatine, sorbitol-sorbitan-opløsning (se punkt 2), glycerol, titandioxid (E 171) og renset vand.
glycerol, titanium dioxide (E171), and purified water.
Xtandi 40 mg filmovertrukne tabletter enzalutamid
Xtandi 40 mg film-coated tablets enzalutamide
Mediantiden indtil PSA-progression var 8,3 måneder for patienter behandlet med enzalutamid og 3,0 måneder for patienter, som modtog placebo [HR = 0,25 (95 % KI: 0,20, 0,30), p <0,0001].
The median time to PSA progression was 8.3 months for patients treated with enzalutamide and 3.0 months for patients who received placebo [HR = 0.25 (95% CI: 0.20, 0.30), p < 0.0001].
80 mg filmovertrukne tabletter
80 mg film-coated tablets
Forudspecificeret interimanalyse Antal dødsfald (%)
Pre-specified interim analysis Number of deaths (%) Median survival, months (95% CI)
behandling af søvnproblemer (f.eks. zolpidem) behandling af hjertesygdomme eller sænkning af blodtryk (f.eks. bisoprolol, digoxin, diltiazem, felodipin, nicardipin, nifedipin, propranolol, verapamil) behandling af alvorlig sygdom relateret til betændelse (f.eks. dexamethason, prednisolon) behandling af HIV-infektion (f.eks. indinavir, ritonavir) behandling af bakterieinfektioner (f.eks. clarithromycin, doxycyclin) behandling af skjoldbruskkirtelsygdomme (f.eks. levothyroxin) behandling af urinsyregigt (f.eks. colchicin) behandling af mavelidelser (f.eks. omeprazol) forebyggelse af hjertesygdomme eller slagtilfælde (f.eks. dabigatran-etexilat) forebyggelse af organafstødning (f.eks. tacrolimus)
- Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine) - Treat gout (e.g. colchicine) - Treat stomach disorders (e.g. omeprazole) - Prevent heart conditions or strokes (e.g. dabigatran etexilate) - Prevent organ rejection (e.g. tacrolimus)
CYP2C8-hæmmere
CYP2C8 inhibitors
Analysen omfattede 448 skeletrelaterede hændelser, hvoraf 277 (62 %) var strålebehandling af knogler, 95 (21 %) var rygmarvskompression,
The analysis involved 448 skeletal-related events, of which 277 events (62%) were radiation to bone, 95 events (21%) were spinal cord compression, 47 events (10%) were pathologic bone fracture, 36 events (8%) were change in antineoplastic therapy to treat bone pain, and 7 events (2%) were surgery to bone.
Hvis du har taget for meget Xtandi
If you take more Xtandi than you should
LÆGEMIDLETS NAVN Xtandi 40 mg
xtandi 40 mg
Xtandi 80 mg filmovertrukne tabletter enzalutamid
Xtandi 80 mg film-coated tablets enzalutamide
Amning
Seizures
behandling af hjertesygdomme eller sænkning af blodtryk (f.eks. bisoprolol, digoxin, diltiazem, felodipin, nicardipin, nifedipin, propranolol, verapamil) behandling af alvorlig sygdom relateret til betændelse (f.eks. dexamethason, prednisolon) behandling af HIV-infektion (f.eks. indinavir, ritonavir) behandling af bakterieinfektioner (f.eks. clarithromycin, doxycyclin) behandling af skjoldbruskkirtelsygdomme (f.eks. levothyroxin) behandling af urinsyregigt (f.eks. colchicin) behandling af mavelidelser (f.eks. omeprazol) forebyggelse af hjertesygdomme eller slagtilfælde (f.eks. dabigatran-etexilat) forebyggelse af organafstødning (f.eks. tacrolimus)
nicardipine, nifedipine, propranolol, verapamil) - Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine)
Polyvinylacetatphthalat
Breast-feeding
Efter oral administration af den bløde kapselformulering (Xtandi 160 mg dagligt) til patienter med metastatisk CRPC er de gennemsnitlige
Following oral administration of the soft capsule formulation (Xtandi 160 mg daily) in patients with metastatic CRPC, the steady-state plasma mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% CV) and 12.7 μg/mL (30% CV), respectively.
INFORMATION I BRAILLESKRIFT xtandi 40 mg filmovertrukne tabletter
Package leaflet: Information for the patient Xtandi 40 mg film-coated tablets
TILLADELSEN
Posology
Elimination
Seizure
Gelatine
Linearity
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/846/003
EU/1/13/846/003
Mave-tarm-kanalen
Capsule shell Gelatin
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/846/002
EU/1/13/846/002
Derved øges evnen til at danne antistoffer.
This improves the ability to produce antibodies.
Vaccination med Vaxelis bør foretages i henhold til officielle anbefalinger.
Vaccination with Vaxelis should be carried out according to official recommendations.
Dette er med til at beskytte mod de sygdomme, som disse bakterier og virus fremkalder.
This helps to protect against the diseases that these bacteria and viruses cause.
Hvad angår sikkerheden fandt CHMP, at den overordnede sikkerhedsprofil svarer til andre vacciners.
With regard to safety, the CHMP considered that overall its safety profile is similar to other vaccines.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vaxelis.
This is a summary of the European public assessment report (EPAR) for Vaxelis.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Vaxelis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Vaxelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Disse koncentrationer af antistoffer er tidligere påvist at beskytte mod disse sygdomme.
These antibody levels have been previously shown to protect against these diseases.
Der er udarbejdet en risikostyringsplan for at sikre, at Vaxelis anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Vaxelis is used as safely as possible.
Den kan anvendes hos spædbørn og småbørn over seks uger til at beskytte mod følgende smitsomme sygdomme:
It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases:
Andre oplysninger om Vaxelis
Other information about Vaxelis
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Vaxelis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Det vil sige, at nogle af de aktive stoffer er hæftet på ganske små partikler af aluminiumforbindelser.
This means that some of the active substances are fixed onto minute particles of aluminium compounds.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vaxelis?
What measures are being taken to ensure the safe and effective use of Vaxelis?
Vacciner virker ved at "lære" organismens naturlige forsvar (immunsystemet) at forsvare organismen mod sygdomme.
Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend itself against diseases.
Der bør gives en forstærkerdosis (boosterdosis) mindst seks måneder efter den sidste af disse indledende doser.
A booster dose should be given at least six months after the last of these initial doses.
Lægemidlet udleveres kun efter recept.
It can only be obtained with a prescription.
Vaxelis er en vaccine.
Vaxelis is a vaccine.
Den anbefalede indledende vaccinationsplan er enten to eller tre doser, der gives med mindst én måneds mellemrum til børn over seks uger.
The recommended initial vaccination schedule is either two or three doses, given at least one month apart to children aged over six weeks.
De fik derefter en boosterdosis kort efter et-årsalderen.
They then received a booster dose shortly after their first birthday.
Det er ikke en praktisk vejledning i, hvordan Vaxelis bør anvendes.
It is not intended to provide practical advice on how to use Vaxelis.
Hvad er Vaxelis, og hvad anvendes det til?
What is Vaxelis and what is it used for?
Vaxelis er undersøgt i to hovedundersøgelser med over 2 500 spædbørn og småbørn over 6 uger, som fik enten to eller tre doser af vaccinen i de første seks levemåneder.
Vaxelis has been studied in two main studies involving more than 2,500 infants and toddlers over six weeks of age who were given either two or three doses of the vaccine during their first six months of life.
Det må ikke anvendes til børn med ukontrolleret eller svær hjerne- eller nervesygdom såsom (anfald af) ukontrolleret epilepsi, medmindre sygdommen er stabiliseret ved behandling, og fordelene ved vaccination klart overstiger risikoen.
It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy (fits), unless the condition has stabilised with treatment and the benefit of vaccination clearly outweighs the risk.
Begge undersøgelser viste, at Vaxelis frembringer tilstrækkelige koncentrationer af antistoffer til at beskytte mod alle disse seks sygdomme hos mellem 90 og 100 % af de børn, der fuldfører vaccinationsprogrammet med Vaxelis.
Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis.
Hvilke risici er der forbundet med Vaxelis?
What are the risks associated with Vaxelis?
Virkningerne af Vaxelis blev sammenlignet med virkningerne af en anden vaccine, Infanrix hexa, der er sammensat med henblik på at beskytte mod de samme seks sygdomme som Vaxelis.
The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis.
Hvorfor blev Vaxelis godkendt?
Why is Vaxelis approved?
• difteri (en meget smitsom sygdom, der angriber halsen og huden og kan beskadige hjertet og andre organer)
• diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs);
Vaxelis må ikke anvendes hos børn, der nogensinde har haft en allergisk reaktion over for Vaxelis eller en vaccine med samme komponenter, herunder de stoffer, der er anvendt ved fremstilling af vaccinen, og som er til stede i yderst små mængder (såsom antibiotikaene neomycin og streptomycin).
Vaxelis must not be used in children who have ever had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vaxelis, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vaxelis, including the appropriate precautions to be followed by healthcare professionals and patients.
Vaxelis indeholder små mængder materiale udvundet af de virus og bakterier, som det beskytter mod.
Vaxelis contains small amounts of materials derived from the viruses and bacteria it protects against.
Vaxelis gives ved indsprøjtning i en muskel, normalt i overlåret eller skulderen.
Vaxelis is given by injection into a muscle, normally in the upper thigh or the shoulder.
Vaccinen har sat sig på overfladen (er "adsorberet") på aluminiumforbindelser.
The vaccine is ‘adsorbed' on aluminium compounds.