FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see section
Danish: Hos patienter med mild til moderat levercirrose (Child-Pugh-klasse A og B), der får voriconazol, anbefales standardinitialdosis, mens vedligeholdelsesdosis halveres (se pkt.
English: There have been rare cases of torsades de pointes in patients taking voriconazole who had risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalaemia and concomitant medicinal products that may have been contributory.
Danish: Hos patienter med risikofaktorer, som f.eks. kardiotoksisk kemoterapi i anamnesen, kardiomyopati, hypokaliæmi og samtidig administration af medicin, der kan have været medvirkende årsag, er der set sjældne tilfælde af torsades de pointes, mens patienterne var i behandling med voriconazol.
English: Voriconazole Cmax ↓ 49% Voriconazole AUCτ ↓ 69%
Danish: Voriconazol Cmax ↓ 49 % Voriconazol AUCτ ↓ 69 %
English: Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk (see section 4.5).
Danish: Samtidig behandling med voriconazol og rifabutin bør undgås, medmindre fordelen opvejer risikoen (se pkt.
English: • Constipation, indigestion, inflammation of the lips
Danish: • Forstoppelse, fordøjelsesbesvær, betændelse i læber
English: Timepoint
Danish: Tidspunkt
English: In case of use as prophylaxis, refer below.
Danish: Se nedenfor for profylaktisk anvendelse.
English: Short acting opiates (CYP3A4 substrate)
Danish: Korttidsvirkende opiater (CYP3A4-substrat)
English: Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Danish: Dosisjustering (børn (2 til <12 år) og unge med lav legemsvægt (12 til 14 år <50kg)) Ved utilstrækkeligt behandlingsrespons kan intravenøs dosis øges i trin på 1 mg/kg.
English: Although not studied, voriconazole is likely to increase the plasma concentrations of ergot alkaloids and lead to ergotism.
Danish: Selvom det ikke er undersøgt, er det sandsynligt, at voriconazol øger plasmakoncentrationen af sekalergotalkaloider og medfører ergotisme.
English: • Jaundice, inflammation of the liver and liver injury
Danish: • Gulsot, leverbetændelse, og leverskade
English: • Pancreatitis which may present with severe abdominal pain
Danish: • Betændelse i bugspytkirtlen, der kan følges af voldsomme mavesmerter
English: What Voriconazole Hikma looks like and contents of the pack Voriconazole Hikma is a white to off-white lyophilised cake.
Danish: Voriconazole Hikma er en hvid til råhvid lyofiliseret masse.
English: Excipient with known effect: Each vial contains 217.6 mg sodium For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hvert hætteglas indeholder 217,6 mg natrium.
English: • Carbamazepine (used to treat seizures)
Danish: • Carbamazepin (medicin mod epilepsi og kramper)
English: In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Danish: Lysoverfølsomhedsreaktioner (1), arytmi (1), pancreatitis (1), forhøjet serum-bilirubin (1), forhøjet antal leverenzymer (1), udslæt (1) og papilødem (1).
English: Completed at least 100 days of study drug prophylaxis
Danish: Succes efter 180 dage* Succes efter 100 dage Afsluttet mindst 100 dage profylakse med studielægemiddel Overlevet til dag 180
English: Voriconazole was investigated as secondary prophylaxis in an open-label, non-comparative, multicenter study of adult allogeneic HSCT recipients with prior proven or probable IFI.
Danish: Sekundær profylakse af invasiv svampeinfektion - virkning hos HSC-transplanterede patienter med forudgående påvist eller sandsynlig invasiv svampeinfektion Voriconazol blev undersøgt som sekundær profylakse i et åbent, ikke-komparativt multicenterstudie hos voksne patienter, der havde fået allogen HSCT med forudgående påvist eller sandsynlig invasiv svampeinfektion.
English: Cardiovascular
Danish: Levertoksicitet
English: Frequent monitoring for adverse reactions and toxicity related to
Danish: Hyppig monitorering for NSAID-relaterede bivirkninger og toksicitet anbefales.
English: Recommendations concerning co-administration inhibitors.
Danish: samtidig administration relaterede bivirkninger.
English: • Stomach pains
Danish: • Mavesmerter
English: Long acting opiates (CYP3A4 substrate)
Danish: Langtidsvirkende opiater (CYP3A4-substrat)
English: Co-administration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations.
Danish: Everolimus (CYP3A4-substrat, P-glykoprotein [P-gp] -substrat) Samtidig administration af voriconazol og everolimus anbefales ikke, fordi voriconazol antages at øge koncentrationen af everolimus signifikant.
English: • Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organs
Danish: • Betændelse i den tynde hinde på indersiden af bugvæggen (bughinden)
English: What you need to know before you take Voriconazole Hikma 3.
Danish: Det skal De vide, før De begynder at bruge Voriconazole Hikma Sådan skal De tage Voriconazole Hikma Bivirkninger
English: 8 mg/kg dose (number of vials)
Danish: 8 mg/kg dosis (antal hætteglas)
English: Intravenous loading doses of 6 mg/kg IV twice daily on day 1 followed by 4 mg/kg intravenous dose twice daily and 300 mg oral tablets twice daily were evaluated in one adolescent pharmacokinetic study.
Danish: 2 gange dagligt eller oralt 300 mg tablet 2 gange dagligt blev evalueret i et farmakokinetik-studie med unge.
English: When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and that of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and
Danish: Efavirenz (CYP450-induktor; CYP3A4-hæmmer og -substrat) Når voriconazol anvendes samtidigt med efavirenz, bør dosis af voriconazol øges til 400 mg hver 12. time, og efavirenz-dosis bør nedsættes til 300 mg hvert 24. time (se pkt.
English: Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Danish: Hvis voriconazol anvendes sekventielt efter fluconazol, anbefales det, at der monitoreres for voriconazol
English: 9 mg/kg dose (number of vials)
Danish: 9 mg/kg dosis (antal hætteglas)
English: Voriconazole Hikma requires reconstitution and dilution (see section 6.6) prior to administration as an intravenous infusion.
Danish: Voriconazole Hikma kræver rekonstituering og fortynding (se pkt.
English: BN
Danish: AML
English: Although not studied, voriconazole is likely to increase the plasma concentrations of vinca alkaloids and lead to neurotoxicity.
Danish: det sandsynligt, at voriconazol kan forøge plasmakoncentrationerne af vinkaalkaloider og forårsage neurotoksicitet.
English: 4 mg/kg dose (number of vials)
Danish: 4 mg/kg dosis (antal hætteglas)
English: *Oral dosage forms of voriconazole are available from other manufacturers **This also applies to patients aged 15 years and older.
Danish: *Orale doseringsformer af voriconazol fås fra andre producenter.
English: 6 mg/kg dose (number of vials)
Danish: 6 mg/kg dosis (antal hætteglas)
English: • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazole Hikma)
Danish: • Non-nukleosid reverse transcriptase-hæmmere (f.eks. efavirenz, delavirdin, nevirapin)
English: 3 mg/kg dose (number of vials)
Danish: 3 mg/kg dosis (antal hætteglas)
English: Voriconazole Hikma treatment will continue for as long as your doctor advises, however the duration of treatment with voriconazole should be no more than 6 months.
Danish: Hvis De holder op med at tage Voriconazole Hikma Behandlingen med Voriconazole Hikma skal fortsætte, så længe Deres læge foreskriver det.
English: How to store Voriconazole Hikma
Danish: Voriconazole Hikma)
English: Ritonavir (protease inhibitor) [potent CYP450 inducer; CYP3A4 inhibitor and substrate] High dose (400 mg BID)
Danish: CYP3A4-hæmmer og -substrat) Høj-dosis (400 mg BID)
English: Voriconazole Cmax ↑ 104%
Danish: Voriconazol Cmax ↑ 104 % Voriconazol AUCτ ↑ 87 %
English: tingling or burning in the hands or feet
Danish: • Hævelse af arme og ben
English: Vinca Alkaloids (e.g., vincristine and vinblastine) [CYP3A4 substrates]
Danish: samtidig administration og vinblastin) [CYP3A4-substrater]
English: Posology
Danish: • Udslæt
English: Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID, (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Danish: BID eller fra 200 mg til 400 mg oralt BID (100 mg til 200 mg oralt BID hos patienter, der vejer mindre end 40 kg) (se pkt.
English: 11 Includes periorbital oedema, lip oedema, and oedema mouth.
Danish: 11 Inkluderer periorbitalt ødem, læbeødem og ødem i munden.
English: Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Danish: De prækliniske date viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og reproduktionstoksicitet.
English: • Overactive thyroid gland
Danish: Hikma Pharma GmbH
English: Co-administration with St John's Wort (see section 4.5).
Danish: Samtidig administration af perikon (se pkt.
English: • Itchiness
Danish: Warwickshire
English: This includes any possible side effects not listed in this leaflet.
Danish: som ikke er medtaget i denne indlægsseddel.
English: Results are presented in Table 9.
Danish: Resultaterne er præsenteret i tabel 9.
English: Frequencies are defined as follows:
Danish: Frekvenserne defineres som følger:
English: Not known: vertigo
Danish: Ikke kendt: vertigo
English: Paediatric population (under 2 years of age)
Danish: Pædiatrisk population (under 2 år)
English: 53100 Siena, Italy
Danish: 53100 Siena, Italien
English: The clinical relevance of this observation is unknown.
Danish: Den kliniske relevans af denne observation er ukendt.
English: See section 4.2 for information on paediatric use.
Danish: 4.2 for information om pædiatrisk brug.
English: It is possible that the effectiveness of Menveo could be reduced in such individuals.
Danish: Effektiviteten af Menveo er muligvis nedsat hos disse personer.
English: (3 years post vaccinati on)
Danish: (3 år efter vaccinati on)
English: The components of the vaccine should be visually inspected before and after reconstitution.
Danish: Komponenterne af vaccinen skal inspiceres visuelt før og efter rekonstitution.
English: Menveo will be given to you or your child by a doctor or nurse.
Danish: Menveo vil blive givet til dig eller dit barn af en læge eller sygeplejerske.
English: Since there was no direct impact on the seroprotection rate, the clinical consequences are presently unknown.
Danish: Da der ikke blev fundet direkte indflydelse på serobeskyttelsesraten, er de kliniske konsekvenser aktuelt ukendte.
English: Immunogenicity was assessed in a subset of 150 subjects in each vaccine group.
Danish: Immunogeniciteten blev vurderet i en undergruppe på 150 forsøgspersoner i hver vaccinegruppe.
English: The hSBA was the original correlate of protection against meningococcal disease.
Danish: hSBA var det oprindelige korrelat for beskyttelse mod meningokoksygdom.
English: Your doctor or nurse will take care to ensure the vaccine is not given into a blood vessel and will make sure that it is injected into muscle and not into the skin.
Danish: Lægen eller sygeplejersken vil sørge for, at vaccinen ikke gives i et blodkar og vil sikre, at den injiceres i en muskel og ikke i huden.
English: Sera were obtained both before vaccination and 1 month after vaccination.
Danish: Sera blev indhentet både før vaccination og 1 måned efter vaccination.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Your doctor or nurse will dispose of this medicine.
Danish: Din læge eller sundhedspersonalet vil bortskaffe denne medicin.
English: Menveo was non-inferior on these endpoints for serogroup C (Table 2).
Danish: Menveo var non-inferiørt på disse endepunkter i serogruppe C (tabel 2).
English: However, chemical and physical stability after reconstitution was demonstrated for 8 hours below 25°C.
Danish: Der er dog påvist kemisk og fysisk stabilitet efter rekonstitution i op til 8 timer ved temperaturer under 25 °C.
English: The use of this vaccine should be in accordance with official recommendations.
Danish: Anvendelse af denne vaccine bør ske i henhold til nationale anbefalinger.
English: However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Danish: Dog er let feber eller infektion i de øvre luftveje (for eksempel forkølelse) ikke i sig selv grund til at udskyde vaccination.
English: This means that you (or your child) should receive other vaccines to protect against diphtheria when these are due or when advised by your doctor.
Danish: Dette betyder, at du (eller dit barn) skal have andre vaccinationer mod difteri, når tiden er inde til dette, eller når lægen anbefaler det.
English: If a severe allergic reaction occurs tell your doctor straight away or go immediately/ take your child to the nearest Accident and Emergency department because urgent medical help may be needed.
Danish: Hvis der opstår en kraftig allergisk reaktion, skal du straks søge læge eller tage til/bringe dit barn til den nærmeste skadestue, da hurtig lægehjælp kan være påkrævet.
English: Concomitant administration of Menveo and other vaccines than those listed above has not been studied.
Danish: Samtidig administration af Menveo og andre vacciner end de ovenfor anførte er ikke undersøgt.
English: Your doctor will tell you if you need an additional injection of Menveo.
Danish: Din læge vil fortælle dig, om du har behov for endnu en injektion af Menveo.
English: Menveo cannot cause bacterial meningitis.
Danish: Menveo kan ikke medføre bakteriel meningitis.
English: The need for and timing of a booster dose in subjects previously vaccinated with Menveo is to be defined based on national recommendations.
Danish: Behovet og tidspunktet for en boosterdosis hos personer, som tidligere er blevet vaccineret med Menveo, skal defineres på grundlag af nationale anbefalinger.
English: It is important that procedures are in place to avoid injury from fainting.
Danish: Det er vigtigt, at der er taget forholdsregler for at undgå personskade ved besvimelse.
English: Menveo is given as an intramuscular injection, preferably into the deltoid muscle.
Danish: Menveo gives som en intramuskulær injektion, helst i musculus deltoideus.
English: The most common local and systemic adverse reactions observed in clinical trials were pain at the injection site and headache.
Danish: De almindeligste lokale og systemiske bivirkninger, der blev observeret i kliniske studier var smerte på injektionsstedet og hovedpine.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 °C - 8 °C).
English: Not known (cannot be estimated from the available data) Adverse reactions from clinical trials
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) Bivirkninger fra kliniske studier
English: Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: • Official batch release
Danish: • Officiel batchfrigivelse:
English: Intramuscular injection.
Danish: Intramuskulær injektion.
English: Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials.
Danish: I alt 3.464 personer i alderen 2 til 10 år blev eksponeret for Menveo i afsluttede kliniske studier.
English: 1 month post-vaccination
Danish: 1 måned efter vaccination
English: Ensure that no air bubbles are present in the syringe before injecting the vaccine.
Danish: Tjek, at der ikke er luftbobler i sprøjten, inden vaccinen injiceres.
English: For information on the reconstitution of the vaccine see the section for medical or healthcare professionals at the end of this leaflet.
Danish: For information om blanding (rekonstitution) af vaccinen, se afsnittet for læger og sundhedspersonale sidst i denne indlægsseddel.
English: This vaccine contains a protein (called CRM197) from the bacteria that cause diphtheria.
Danish: Denne vaccine indeholder et protein (kaldet CRM197) fra den bakterie, der forårsager difteri.
English: The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups.
Danish: Forekomsten og sværhedsgraden af lokale reaktioner, systemiske reaktioner og andre reaktioner var generelt de samme i Menveo-grupperne i alle studier både hos unge og voksne.
English: After vaccination, over 97% of subjects had detectable pertussis titers to all three pertussis antigens.
Danish: Efter vaccinering havde mere end 97 % af forsøgspersonerne en registreret pertussis-titer for alle tre pertussis-antigener.
English: In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Danish: I prækliniske studier havde Menveo ingen direkte eller indirekte skadelige virkninger på graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling.
English: There was no evidence of an increased rate of reactogenicity or change in the safety profile of the vaccines in either study.
Danish: Ingen af studierne indikerede øget reaktogenicitetsrate eller ændringer i sikkerhedsprofilen for vaccinerne.
English: Bellaria-Rosia 53018 Sovicille (SI) Italy
Danish: Bellaria-Rosia 53018 Sovicille (SI) Italien
English: Serum bactericidal activity (SBA) was measured using human serum as the source of exogenous complement (hSBA).
Danish: Serum-baktericid aktivitet (SBA) blev målt ved brug af humant serum som kilde for eksogen komplement (hSBA).
English: Talk to your doctor or nurse before you or your child are given Menveo if you or your child: - have a weakened immune system.
Danish: Kontakt lægen eller sundhedspersonalet, før du eller dit barn bruger Menveo: - hvis du eller dit barn har et svækket immunsystem.
English: 21 months
Danish: 21 måneder
English: Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose.
Danish: Bemærk, at det er normalt, at der er en lille mængde væske tilbage i hætteglasset efter optrækning af dosis.
English: The administration of Menveo one month after Tdap resulted in statistically significantly lower serogroup W-135 seroresponses.
Danish: Administration af Menveo en måned efter Tdap medførte en statistisk markant lavere serogruppe W135-responsrate.
English: The vaccine works by causing your body to make its own protection (antibodies) against these bacteria.
Danish: Vaccinen virker ved at stimulere kroppens egen beskyttelse (dannelse af antistoffer) mod disse bakterier.
English: The efficacy of Menveo has been inferred by measuring the production of serogroup-specific anti-capsular antibodies with bactericidal activity.
Danish: Effektiviteten af Menveo er blevet undersøgt ved måling af produktion af serogruppe-specifikke anti-kapsulære antistoffer med baktericid aktivitet.
English: The immunogenicity of Menveo in children 2 to 23 months of age was evaluated in several studies.
Danish: Menveos immunogenicitet hos børn i alderen fra 2 til 23 måneder er blevet evalueret i flere studier.
English: As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following administration of the vaccine.
Danish: Som ved alle injicerbare vacciner skal relevant nødhjælpsbehandling og overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: - receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
Danish: - hvis du eller dit barn modtager behandling, som blokerer den del af immunsystemet, kendt som komplement aktivering, såsom eculizumab.
English: Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and reproductive and developmental toxicity studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: Tell your doctor or nurse if you have experienced this kind of reaction previously.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du tidligere har haft en sådan reaktion.
English: The clinical relevance of higher post-vaccination immune responses is not known.
Danish: Den kliniske relevans af højere immunrespons efter vaccination kendes ikke.
English: Pre-boo ster 7 days 28 days 100% 2 years
Danish: Præboo ster 7 dage 28 dage 100 % 2 år
English: Individuals 11 to 65 years of age
Danish: Personer i alderen 11-65 år
English: While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people.
Danish: Hiv-infektion er ikke en kontraindikation, men Menveo er ikke evalueret specifikt hos immunkompromitterede personer.
English: Reconstitution of the vaccine
Danish: Rekonstitution af vaccinen
English: For children (from 2 years of age), adolescents and adults: a single (0.5 ml) injection will be given.
Danish: Til børn (fra 2 år), unge og voksne: der gives en enkelt (0,5 ml) indsprøjtning.
English: P Value Menveo vs
Danish: P-værdi Menveo vs
English: Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible foreign particles.
Danish: Efter rekonstitution er vaccinen en klar, farveløs til lysegul opløsning uden synlige fremmedpartikler.
English: Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.
Danish: Samtidig vaccination skal altid administreres på separate injektionssteder og helst kontralateralt.
English: In laboratory animals, no adverse reactions were seen in vaccinated maternal rabbits or in their offspring through postnatal day 29.
Danish: I dyrestudier blev der ikke set bivirkninger hos vaccinerede drægtige kaniner eller deres afkom frem til postnatal dag 29.
English: As with other vaccines, Menveo should be postponed in individuals suffering from an acute severe febrile illness.
Danish: Som med andre vacciner bør administration udskydes ved akut svær febril lidelse.
English: Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant.
Danish: Selv om der foreligger utilstrækkelige kliniske data for anvendelse af Menveo under amning, er det usandsynligt, at antistoffer der udskilles i mælken vil være skadelige for det ammende barn.