FrancophonIA/ELRC3.0 huggingface dataset:
English: Meropenem and vaborbactam are removed by haemodialysis (see section 5.2).
Danish: Meropenem og vaborbactam fjernes ved hæmodialyse (se pkt.
English: • you have ever had a severe allergic reaction to related antibiotics belonging to the beta-lactam group
Danish: • du nogensinde har haft en kraftig allergisk reaktion over for beslægtede antibiotika, der tilhører beta-lactam-gruppen (herunder penicilliner, cefalosporiner eller monobactamer)
English: Hospital-acquired pneumonia (HAP), including VAP
Danish: Hospitalserhvervet pneumoni (HAP) inkl.
English: Thrombocythaemia Leucopenia Neutropenia
Danish: Leukopeni Neutropeni Eosinofili Trombocytopeni
English: Abdominal distension
Danish: Abdominal
English: Patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem/vaborbactam.
Danish: Under behandling med meropenem/vaborbactam bør leverfunktionen monitoreres hos patienter med allerede eksisterende leversygdomme.
English: Each vial contains 10.9 mmol of sodium (approximately 250 mg).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hvert hætteglas indeholder 10,9 mmol natrium (cirka 250 mg).
English: How to store Vaborem
Danish: Hvad er Vaborem?
English: Vaborbactam does not inhibit class B enzymes (metallo-β-lactamases) or class D carbapenemases.
Danish: enzymer (metallo-β-lactamaser) eller klasse D-carbapenemaser.
English: What Vaborem is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: • Painful veins
Danish: • Vejrtrækningsbesvær
English: • Reduction in the way your kidneys work
Danish: • Fald i nyrefunktion
English: thoracic and mediastinal disorders Gastrointestinal disorders
Danish: Luftveje, thorax og mediastinum
English: Dosing Interval
Danish: Doseringsinterval
English: To prepare the Vaborem 0.5 g/0.5 g dose for intravenous infusion: Immediately after reconstitution of one vial,10.5 ml of the reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Danish: Sådan klargøres en dosis Vaborem 0,5 g/0,5 g til intravenøs infusion: Straks efter rekonstitution af ét hætteglas skal 10,5 ml af indholdet af det rekonstituerede hætteglas trækkes op fra hætteglasset og hældes tilbage i den 250 ml infusionspose med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske (normalt saltvand).
English: (≥1/1,000 to
Danish: Ikke almindelig (≥1/1.000 til
English: Tremor Lethargy Dizziness Paraesthesia
Danish: Tremor Letargi Svimmelhed Paræstesi
English: Vaborem is intended for intravenous (IV) administration, only after reconstitution and dilution.
Danish: administration, men først efter rekonstitution og fortynding.
English: • A feeling of being sleepy and sluggish
Danish: • En stikkende og prikkende fornemmelse
English: To prepare the Vaborem 2 g/2 g dose for intravenous infusion: Immediately after reconstitution of two vials, the entire reconstituted vial contents should be withdrawn from each of the two vials and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Danish: Sådan klargøres en dosis Vaborem 2 g/2 g til intravenøs infusion: Straks efter rekonstitution af to hætteglas skal hele indholdet af det rekonstituerede hætteglas trækkes op fra hvert af de to hætteglas og hældes tilbage i den 250 ml infusionspose med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske (normalt saltvand).
English: To prepare the Vaborem 1 g/1 g dose for intravenous infusion: Immediately after reconstitution of one vial, the entire reconstituted vial contents should be withdrawn from the vial and added back into the 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection (normal saline).
Danish: Sådan klargøres en dosis Vaborem 1 g/1 g til intravenøs infusion: Straks efter rekonstitution af ét hætteglas skal hele indholdet af det rekonstituerede hætteglas trækkes op fra hætteglasset og hældes tilbage i den 250 ml infusionspose med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske (normalt saltvand).
English: Phlebitis Vascular pain
Danish: Flebitis Vaskulære smerter
English: • you have ever had any allergic reaction to other antibiotics belonging to the beta-lactam group
Danish: • du nogensinde har haft en hvilken som helst allergisk reaktion over for andre antibiotika, der tilhører beta-lactam-gruppen (herunder carbapenemer, penicilliner, cefalosporiner eller monobactamer).
English: Dilution
Danish: Hypotension
English: Gram-negative micro-organisms: • Citrobacter freundii
Danish: • Citrobacter freundii
English: Diarrhoea Nausea Vomiting
Danish: Nausea Opkastning distension Abdominalsmerter
English: Convulsions
Danish: Inkontinens
English: Vaborem will be given to you by a doctor or nurse by infusion (a drip) into a vein, lasting 3 hours.
Danish: Det gives som en infusion (et drop) i en blodåre.
English: Injection site phlebitis
Danish: Flebitis på injektionsstedet
English: If any of the above apply to you or you are not sure, talk to your doctor or nurse before using Vaborem.
Danish: Tal med lægen eller sundhedspersonalet, inden du får Vaborem, hvis ovenstående gør sig gældende for dig, eller hvis du er i tvivl.
English: Pain
Danish: VAP
English: • Inability to sleep
Danish: • Søvnbesvær
English: Κύπρος Γ. Α. Σταμάτης & Σια Λτδ.
Danish: Γ. Α. Σταμάτης & Σια Λτδ.
English: Important information about the protection provided
Danish: Vigtige oplysninger om den tilvejebragte beskyttelse
English: Results obtained for each of the components are summarised in the tables below:
Danish: De opnåede resultater for hvert indholdsstof er opsummeret i tabellerne herunder:
English: Your doctor will tell you when this dose should be given.
Danish: Lægen vil fortælle, hvornår denne dosis bør gives.
English: No cases of overdose have been reported.
Danish: Der er ikke rapporteret om tilfælde med overdosering.
English: If not, your child may not be fully protected against the diseases.
Danish: Ellers vil barnet ikke være fuldt beskyttet mod sygdommene.
English: If you forget one dose of Hexacima
Danish: Hvis du har glemt en dosis Hexacima
English: Your doctor will assess the potential benefit offered by vaccination.
Danish: Lægen vil vurdere den mulige fordel ved vaccination.
English: However, a lower immune response may be observed and the level of clinical protection is unknown.
Danish: Et lavere immunrespons kan dog ses, og det kliniske beskyttelsesniveau er ukendt.
English: Efficacy and effectiveness in protecting against pertussis
Danish: Effekt og effektivitet i beskyttelse mod pertussis
English: All symptoms should disappear completely within 24 hours without need for treatment.
Danish: Alle symptomer vil fuldstændigt forsvinde inden for 24 timer uden behov for behandling
English: The vaccine will never be given into a blood vessel or into or under the skin.
Danish: Vaccinen vil aldrig gives ind i et blodkar eller ind i eller under huden.
English: There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh possible risks.
Danish: Der kan være omstændigheder, som f.eks. ved høj forekomst af pertussis, hvor de potentielle fordele opvejer de mulige risici.
English: Serious allergic reactions are a rare possibility (may affect up to 1 in 1,000 people) after receiving this vaccine.
Danish: Alvorlige, allergiske reaktioner er en sjælden mulighed (kan påvirke op til 1 ud af 1.000) efter at have fået denne vaccine.
English: Effectiveness in protecting against Hib invasive disease
Danish: Effektivitet i beskyttelse mod Hib invasiv sygdom
English: In this case, the decision to give any further vaccine containing tetanus toxoid should be evaluated by your doctor.
Danish: I dette tilfælde skal beslutningen om at give en yderligere vaccine, der indeholder tetanus toxoid, vurderes af lægen.
English: The suspension should be visually inspected prior to administration.
Danish: Suspensionen skal ses efter inden administrationen.
English: • Temperature of ≥ 40°C within 48 hours not due to another identifiable cause;
Danish: • Temperatur ≥ 40 C inden for 48 timer, som ikke skyldes anden identificérbar årsag;
English: Your child could get diseases with similar symptoms if they are caused by other bacteria or viruses.
Danish: Dit barn kan få sygdomme med lignende symptomer, hvis de stammer fra andre bakterier eller virus.
English: Abnormal crying (prolonged crying)
Danish: Unormal gråd (langvarig gråd)
English: * Adverse reactions from spontaneous reporting.
Danish: * Bivirkninger fra spontan rapportering.
English: Vaccination with Hexacima may need to be delayed until your child is better.
Danish: Vaccination med Hexacima skal måske vente, indtil dit barn får det bedre.
English: The following convention has been used for the classification of adverse reactions; Very common (≥1/10)
Danish: Følgende konventioner er blevet anvendt ved klassificeringen af bivirkninger: Meget almindelig (≥1/10)
English: LLOQ value for anti-PT and anti-FHA is 2 EU/ml
Danish: LLOQ værdi for anti-PT og anti-FHA er 2 EU/ml
English: This vaccine should be used according to the local vaccination programme.
Danish: Vaccinen skal gives i overensstemmelse med det lokale vaccinationsprogram.
English: Other tests should be performed in order to confirm Hib infection during this period.
Danish: Der skal i denne periode udføres andre prøver for at bekræfte Hib infektion.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelen ved vaccination er stor hos denne gruppe spædbørn, bør vaccination ikke undlades eller forsinkes.
English: • The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.
Danish: • Vaccinen indeholder ikke levende bakterier eller virus, og den kan ikke give nogen af de smitsomme sygdomme, som den beskytter imod.
English: For adsorbent: see section 2.
Danish: For adsorbans: Se punkt 2.
English: Read all of this leaflet carefully before your child is vaccinated because it contains important information for him/her.
Danish: Læs denne indlægsseddel grundigt, inden dit barn bliver vaccineret, da den indeholder vigtige oplysninger.
English: The need for a toddler booster dose was seen in this study.
Danish: Behovet for en booster dosis til småbørn blev klarlagt i dette studie.
English: It is normally recommended to wait until the end of the treatment or disease before vaccinating.
Danish: Det anbefales normalt at vente indtil afslutningen af behandlingen eller sygdommen, før der vaccineres.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlæggelsesseddel blev senest ændret i {MM/ÅÅÅÅ}.
English: 4.8 Undesirable effects a- Summary of the safety profile
Danish: 4.8 Bivirkninger a- Oversigt over sikkerhedsprofilen
English: Results of long term follow-up demonstrated a dramatic reduction of the pertussis incidence following the second dose regardless of the vaccine used.
Danish: Resultater af langvarig opfølgning viste en dramatisk reduktion af pertussisforekomst efter den anden dosis, uanset hvilken vaccine, der blev anvendt.
English: However children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Hexacima but the protection may not be as good as in children whose immune system is healthy.
Danish: Men børn med langvarige problemer med deres immunsystem, såsom HIV-infektion (AIDS), kan stadig gives Hexacima, men beskyttelsen er muligvis ikke så god som hos børn med sundt immunsystem.
English: The risk appears to be dependent on the number of prior doses of acellular pertussis containing vaccine, with a greater risk following the 4th and 5th doses.
Danish: Risikoen afhænger tilsyneladende af antal forudgående doser af vaccine, der indeholder acellulær pertussis, med en større risiko efter 4. og 5. dosis.
English: Immune responses to the vaccine have not been studied in the context of genetic polymorphism.
Danish: Immunrespons på vaccinen er ikke undersøgt i sammenhæng med genetisk polymorfi.
English: The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination.
Danish: Eksisterende mindre infektion og/eller lav feber bør ikke føre til udsættelse af vaccination.
English: The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Danish: Vaccinens virkning var 96,7 % for den fulde primærserie og 98,5 % for booster dosis (uanset priming).
English: It is recommended to postpone vaccination until the end of such treatment or disease.
Danish: Det anbefales at udsætte vaccination til afslutningen af en sådan behandling eller sygdom.
English: It can lead to paralysis or muscle weakness most commonly of the legs.
Danish: Den kan føre til lammelse eller muskelsvaghed, almindeligst i benene.
English: Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity and local tolerance studies.
Danish: Ikke-kliniske data viser ingen speciel risiko for mennesker, vurderet ud fra konventionelle studier af toksicitet efter gentagne doser og lokal tolerance.
English: In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer.
Danish: I nogle tilfælde kan virusen blive i kroppen i lang tid og kan ende med at føre til alvorlige leverproblemer, herunder kræft i leveren.
English: Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
Danish: Må ikke administreres ved intravaskulær injektion: Sørg for, at nålen ikke penetrerer et blodkar.
English: Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse reactions).
Danish: Før vaccination skal patientens medicinske historik gennemgås (specielt tidligere vaccinationer og eventuelle reaktioner).
English: When these signs or symptoms (signs or symptoms of anaphylactic reaction) occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor's surgery.
Danish: Hvis disse tegn eller symptomer (tegn eller symptomer på anafylaktisk reaktion) optræder, udvikler de sig normalt hurtigt, efter at injektionen er givet, og mens barnet endnu er på klinikken eller hos lægen.
English: • Hexacima should not be mixed with other medicinal products.
Danish: • Hexacima må ikke blandes med andre lægemidler.
English: The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause these different infections:
Danish: Vaccinen virker ved at få kroppen til at producere sin egen beskyttelse (antistoffer) mod de bakterier og virus, der er årsag til disse forskellige smitsomme sygdomme:
English: Your doctor will advise you whether your child should have Hexacima.
Danish: Lægen vil rådgive dig, om barnet bør få Hexacima.
English: Before the injection of any biological, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions.
Danish: Inden injektion af et biologisk produkt skal den ansvarlige for administrationen tage alle kendte forsigtighedsregler for forebyggelse af allergiske eller andre reaktioner.
English: • Hexacima will only help to prevent these diseases if they are caused by the bacteria or viruses targeted by the vaccine.
Danish: • Hexacima hjælper kun med at forebygge disse sygdomme, hvis de stammer fra de bakterier eller virus, som denne vaccine er rettet imod.
English: • Hepatitis B is caused by the hepatitis B virus.
Danish: • Hepatitis B forårsages af hepatitis B virus.
English: Pertussis vaccine should not be administered to individuals with uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.
Danish: Pertussis vaccine må ikke administreres til patienter med ukontrolleret, neurologisk forstyrrelse eller ukontrolleret epilepsi, før behandling for tilstanden er fastlagt, tilstanden er stabiliseret, og fordelen klart opvejer risikoen.
English: Serious allergic reactions (anaphylactic reaction)
Danish: Alvorlige, allergiske reaktioner (anafylaktisk reaktion)
English: • Bordetella pertussis antigens : Pertussis Toxoid/Filamentous Haemagglutinin 25/25 µg
Danish: • Bordetella pertussis antigener: Pertussis toxoid/Filamentøs hæmagglutinin 25/25 µg
English: Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection.
Danish: Immunisering skal udskydes hos patienter med moderat til svær akut febersygdom eller infektion.
English: The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency.
Danish: Vaccinens immunogenicitet kan blive reduceret ved immunosuppressiv behandling eller immundefekt.
English: Very rare (<1/10,000) Not known (cannot be estimated from available data)
Danish: Ikke kendt (kan ikke estimeres ud fra tilgængelige data)
English: No data are available for premature infants.
Danish: Der foreligger ingen data for præmature spædbørn.
English: Primary 6-10-14 weeks and booster at 15-18 months
Danish: Primærvaccination 6-10-14 uger og booster ved 15-18 måneder
English: The primary vaccination consists of two doses (with an interval of at least 8 weeks) or three doses (with an interval of at least 4 weeks) in accordance with the official recommendations.
Danish: Den primære vaccination består af to doser (med et interval på mindst 8 uger) eller tre doser (med et interval på mindst 4 uger) i overensstemmelse med de officielle anbefalinger.
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1 to 2 weeks following vaccination.
Danish: Da Hib kapselpolysaccharid antigenet udskilles i urinen, kan en positiv urinprøve observeres inden for 1 til 2 uger efter vaccination.
English: • has any problems with the blood that cause easy bruising or bleeding for a long time after minor cuts.
Danish: • har problemer med blodet, der nemt giver blå mærker eller blødning i lang tid efter mindre rifter.
English: At the injection sites, chronic histological inflammatory changes were observed, that are expected to have a slow recovery.
Danish: På injektionssteder er observeret kroniske, histologiske, inflammatoriske ændringer, der forventes at have en langsom restitution.
English: Anaphylactic reaction*
Danish: Anafylaktisk reaktion*
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: To make sure that Hexacima is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child.
Danish: For at være sikker på, at Hexacima er egnet til dit barn, er det vigtigt at tale med lægen eller sundhedspersonalet, hvis bare ét af punkterne herunder gælder dit barn.
English: • is having a treatment that suppresses her/his immune system (the body's natural defenses) or has any disease that causes the weakness of the immune system.
Danish: • modtager en behandling, der undertrykker hans/hendes immunsystem (kroppens naturlige forsvar), eller hvis barnet har en sygdom, der forårsager svækkelse af immunsystemet.
English: Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent doses.
Danish: Der blev observeret lidt højere reaktogenicitet efter den første dosis i forhold til efterfølgende doser
English: DTaP-IPV-HB-Hib
Danish: DTaP-IPV-HBV-Hib
English: The administration of Hexacima must be carefully considered in individuals who have a history of serious or severe reactions within 48 hours following administration of a vaccine containing similar components.
Danish: Administration af Hexacima skal overvejes omhyggeligt hos individer, der har en anamnese med svære eller alvorlige reaktioner inden for 48 timer fra administrering af en vaccine med lignende indholdsstoffer.
English: • blueness of the tongue or lips
Danish: • tungen eller læberne er blå
English: In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or medicinal products.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må denne vaccine ikke blandes med andre vacciner eller lægemidler.
English: • As with any vaccine, Hexacima may not protect 100% of children who receive the vaccine.
Danish: • Som med enhver anden vaccine beskytter Hexacima ikke nødvendigvis 100 % af børn, der modtager vaccinen.
English: • In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2 - 3 days after vaccination.
Danish: • Hos meget tidligt fødte spædbørn (28 ugers graviditet eller før) kan der gå længere tid end normalt mellem åndedragene i 2-3 dage efter vaccination.
English: The vaccine may not prevent hepatitis B infection in such cases.
Danish: Vaccinen forebygger muligvis ikke en hepatitis B infektion i sådanne tilfælde.
English: Hexacima is given as an injection into a muscle (intramuscular route IM) in the upper part of your child's leg or upper arm.
Danish: Hexacima gives som en injektion ind i en muskel (intramuskulært, IM) i den øverste del af barnets ben eller overarm.
English: In clinical studies in individuals who received Hexacima, the most frequently reported reactions include injection-site pain, irritability, crying, and injection-site erythema.
Danish: I kliniske undersøgelser hos individer, der fik Hexacima, omfattede de hyppigst indberettede reaktioner smerte på injektionsstedet, irritabilitet, gråd og erytem på injektionsstedet.
English: d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexacima and not directly with Hexacima)
Danish: d- Potentielle bivirkninger (dvs. bivirkninger, der er indberettet for andre vacciner, der indeholder et eller flere indholdsstoffer eller bestanddele i Hexacima og ikke direkte for Hexacima).
English: It causes the liver to become swollen (inflamed).
Danish: Den får leveren til at blive hævet (inflammeret).
English: Paralysis of the muscles that control breathing and swallowing can be fatal.
Danish: Lammelse af de muskler, der kontrollerer åndedræt og synkning, kan være dødelig.
English: Date of latest renewal: 08 January 2018
Danish: Dato for første markedsføringstilladelse: 17. april 2013 Dato for seneste fornyelse: 8. januar 2018
English: The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Danish: Den potentielle risiko for apnø og behovet for respiratorisk overvågning i 48-72 timer skal tages i betragtning, når den primære immuniseringsserie administreres til meget præmature børn (født efter ≤ 28 ugers svangerskab) og især til dem med en tidligere historik for respirationsimmaturitet.
English: Hexacima must not be mixed with any other vaccines or other parenterally administered medicinal products.
Danish: Hexacima må ikke blandes med andre vacciner eller andre parenteralt administrerede lægemidler.
English: If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY:
Danish: Hvis et eller flere af disse symptomer optræder, efter at du har forladt stedet, hvor barnet modtog injektionen, skal du ØJEBLIKKELIG kontakte en læge:
English: Very common Crying, somnolence Common
Danish: Meget almindelig Gråd, døsighed Almindelig
English: Booster doses should be given at least 6 months after the last priming dose and in accordance with the official recommendations.
Danish: Boosterdoser skal indgives mindst 6 måneder efter den sidst indgivne dosis og i overensstemmelse med de officielle anbefalinger.
English: In these cases the immune response to the vaccine may be decreased.
Danish: I disse tilfælde kan immunrespons på vaccinen være nedsat.