FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have a blood disorder or any type of cancer that weakens your immune system
Danish: • hvis De har en blodsygdom eller enhver form for kræft, der svækker immunsystemet
English: The requirements for submission of periodic safety update reports for this medicinal products are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: 286 subjects received two doses and 9 subjects received only one dose.
Danish: 286 patienter fik to doser, og 9 forsøgspersoner fik kun én dosis.
English: Adults receiving additional doses/revaccination
Danish: Voksne der fik flere doser/blev revaccineret
English: Avoid contact with disinfectants as they may inactivate the vaccine virus.
Danish: Undgå kontakt med desinficerende midler da disse kan inaktivere vaccinevirus.
English: Average VE§
Danish: Gennemsnitlig VE§
English: Some of these reactions may be serious and may include difficulty in breathing or swallowing.
Danish: Nogle af disse reaktioner kan være alvorlige og omfatte åndedrætsbesvær eller synkebesvær.
English: ZOSTAVAX is given as a single dose.
Danish: ZOSTAVAX gives i en enkelt dosis.
English: † VE was estimated for the first episode of herpes zoster during follow-up and was calculated as (1-hazards ratio)*100.
Danish: † VE blev estimeret for den første episode med herpes zoster i opfølgningsperioden og blev beregnet som (1-hazards ratio)*100.
English: In the SPS, the reduction in zoster was seen in almost all dermatomes.
Danish: I SPS blev der set en reduktion af zostertilfælde i næsten alle dermatomer.
English: • if you have or have had any medical problems or any allergies
Danish: • hvis De har eller har haft sygdomsrelaterede problemer eller allergiske reaktioner
English: However, data collected in a large observational study did not indicate increased risk for developing herpes zoster after concomitant administration of the two vaccines.
Danish: Data, som blev indsamlet i et større observationsstudie, tydede dog ikke på øget risiko for at udvikle herpes zoster efter samtidig administration af de to vacciner.
English: In clinical trials, general safety has been evaluated in more than 57,000 adults vaccinated with ZOSTAVAX.
Danish: I kliniske studier er den generelle sikkerhed blevet undersøgt på flere end 57.000 voksne vaccineret med ZOSTAVAX.
English: This is a theoretical risk for vaccination with ZOSTAVAX.
Danish: Dette udgør en teoretisk risiko ved vaccination med ZOSTAVAX.
English: No data are currently available regarding concomitant use with other vaccines.
Danish: Der forefindes på nuværende tidspunkt ingen data vedrørende samtidig brug med andre vacciner.
English: ZOSTAVAX should be injected under the skin or into the muscle, preferably in the upper arm.
Danish: ZOSTAVAX skal injiceres under huden eller i en muskel, helst på overarmen.
English: The safety and efficacy of ZOSTAVAX in children and adolescents have not been established.
Danish: Sikkerhed og virkning af ZOSTAVAX hos børn og unge er ikke klarlagt.
English: The following side effects have been observed:
Danish: Der er set følgende bivirkninger:
English: Sometimes, after many years, the virus becomes active again and causes shingles.
Danish: Undertiden bliver virussen aktiv igen efter mange år og forårsager helvedesild.
English: Data from a clinical trial (n=368) demonstrated that the current refrigerated formulation has a safety profile comparable to that of the frozen formulation.
Danish: Data fra et klinisk studie (n=368) viste, at den aktuelle formulering til opbevaring på køl har en sikkerhedsprofil, som svarer til den frosne formulering.
English: Arthralgia, Myalgia, Pain in extremity
Danish: Artralgi, myalgi, smerter i ekstremiteter
English: Hypersensitivity reactions including anaphylactic reactions
Danish: Overfølsomhedsreaktioner herunder anafylaktiske reaktioner
English: Adverse events were followed up to Day 42 post vaccination and serious adverse events throughout the entire study period (i.e. through Day 180).
Danish: Der blev fulgt op på alle hændelser indtil Dag 42 efter vaccination, og opfølgningen på alvorlige hændelser varede i hele studieperioden (dvs. til og med Dag 180).
English: Very rare (<1/10,000)
Danish: Meget sjælden (<1/10.000)
English: ZOSTAVAX Efficacy and Safety Trial (ZEST) in subjects 50 to 59 years of age:
Danish: ZOSTAVAX Efficacy and Safety Trial (ZEST) med forsøgspersoner i alderen 50 til 59 år:
English: In the LTPS, there were 263 evaluable zoster cases reported among 261 patients [10.3/1000 person-years].
Danish: I LTPS blev der indberettet 263 evaluerbare zostertilfælde hos 261 patienter [10,3/1000 person-år].
English: This risk appears to be causally related to a decline in VZV-specific immunity.
Danish: Deres risiko synes at være kausalt forbundet med et fald i den VZVspecifikke immunitet.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Immunisation should be postponed in individuals suffering from moderate to severe acute febrile illness or infection.
Danish: Immunisering bør udskydes hos personer med moderat til svær akut febril sygdom eller infektion.
English: Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur.
Danish: Mindre hyppigt kan der forekomme bakterielle hudinfektioner, slaphed, muskellammelse og tab af hørelse eller syn.
English: Immunocompromised subjects The vaccine has not been studied in subjects with impaired immunity.
Danish: Immunkompromitterede personer Vaccinen er ikke undersøgt hos personer med svækket immunitet.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
Danish: Hvis De er gravid eller ammer, har mistanke om at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De bliver vaccineret.
English: Consequently, the frequencies of these adverse reactions have been estimated based on the adverse events reported in SPS and ZEST (regardless of vaccine relationship assigned by the investigator).
Danish: Derfor er hyppigheden af disse bivirkninger estimeret på grundlag af de hændelser, der blev rapporteret i SPS og ZEST (uanset investigators angivelse af sammenhængen med vaccinen).
English: A decision must be made whether to discontinue breast-feeding or to not administer ZOSTAVAX taking into account the benefit of breast-feeding for the child and the benefit of vaccination for the woman.
Danish: Der skal tages en beslutning om enten at stoppe amningen eller undlade at give ZOSTAVAX under hensyntagen til barnets gavn af at blive ammet og kvindens gavn af at blive vaccineret.
English: A total of 48,889 confirmed HZ cases and 3,316 confirmed PHN cases (>90 days of zoster-associated pain) were observed.
Danish: Der blev observeret i alt 48.889 bekræftede HZ-tilfælde og 3.316 bekræftede PHN-tilfælde (>90 dage med zosterassocierede smerter).
English: Fertility ZOSTAVAX has not been evaluated in fertility studies.
Danish: Fertilitet ZOSTAVAX er ikke blevet evalueret i fertilitetsstudier.
English: • Active untreated tuberculosis.
Danish: • Aktiv tuberkulose der ikke behandles.
English: Vaccine efficacy (95% CI)
Danish: Vaccinens effekt (95 % CI)
English: Incidence rate of PHN per person years
Danish: Incidensrate for PHN per personår
English: The data do not indicate that concomitant administration alters the effectiveness of ZOSTAVAX.
Danish: Dataene tyder ikke på, at samtidig administration ændrer ZOSTAVAX' effektivitet.
English: Injection site: Erythema
Danish: Injektionsstedet: Erytem
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De bliver vaccineret, da den indeholder vigtige oplysninger.
English: Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur.
Danish: I sjældne tilfælde (kan forekomme hos op til 1 ud af 1000 personer) kan der forekomme allergiske reaktioner.
English: The need for, or timing of, a booster dose with ZOSTAVAX has not yet been determined.
Danish: Behovet eller tidspunktet for en boosterdosis af ZOSTAVAX er endnu ikke blevet fastslået.
English: Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Danish: Denne vaccine kan som al anden vaccine og medicin give bivirkninger, men ikke alle får bivirkninger.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine; ATC code: J07BK02
Danish: Farmakoterapeutisk klassifikation: Vacciner, Virusvaccine; ATC-kode: J07BK02
English: Incidence rate of zoster per person years
Danish: Incidensrate for zoster per personår
English: The vaccine should under no circumstances be injected intravascularly.
Danish: Vaccinen må under ingen omstændigheder injiceres intravaskulært.
English: Abbreviations: VE denotes vaccine effectiveness; CI confidence interval; DxCG diagnostic cost group; HCUP healthcare cost and utilization project
Danish: Forkortelser: VE står for vaccine-effektivitet; CI: konfidensinterval; DxCG: diagnostic cost group; HCUP: healthcare cost and utilization project
English: In an interim analysis of the 2007 to 2014 study period, out of 1,355,720 study individuals, 392,677 received ZOSTAVAX.
Danish: I en interimanalyse af studieperioden 2007 til 2014 fik 392.677 ud af 1.355.720 forsøgspersoner ZOSTAVAX.
English: Produced in human diploid (MRC-5) cells
Danish: Produceret i humane diploide (MRC-5) celler
English: There are no data on the use of ZOSTAVAX in pregnant women.
Danish: Der foreligger ingen data vedrørende brug af ZOSTAVAX til gravide kvinder.
English: Traditional non-clinical studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Traditionelle non-kliniske studier er utilstrækkelige med hensyn til reproduktionstoksicitet (se pkt.
English: The results showed that ZOSTAVAX is effective in reducing HZ and PHN incidence in vaccinated individuals as compared to an unvaccinated reference group.
Danish: Resultaterne viste, at ZOSTAVAX er effektivt til at reducere HZ- og PHN-incidensen hos vaccinerede personer sammenlignet med en ikke-vaccineret referencegruppe.
English: There is no relevant use of ZOSTAVAX in children and adolescents for prevention of primary varicella infection (chickenpox).
Danish: Det er ikke relevant at anvende ZOSTAVAX til børn og unge til forebyggelse af primær varicellainfektion (skoldkopper).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this vaccine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Reconstitution instructions intended for healthcare professionals are included at the end of the leaflet.
Danish: Rekonstitutionsanvisninger til læger og sundhedspersonale findes sidst i indlægssedlen.
English: Vaccine effectiveness (VE) against HZ was evaluated for up to eight years postvaccination.
Danish: Vaccine-effektivitet (VE) mod HZ blev evalueret i op til 8 år efter vaccination.
English: Do not use this vaccine after the expiry date which is stated on the outer carton after EXP.
Danish: Brug ikke denne vaccine efter den udløbsdato, der står på pakningen.
English: This long-lasting nerve pain is called post-herpetic neuralgia or PHN.
Danish: Disse langvarige nervesmerter kaldes postherpetisk neuralgi eller PHN.
English: Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing zoster.
Danish: Enhver, der har været inficeret med VZV, herunder personer uden varicella i den kliniske anamnese, har risiko for at udvikle herpes zoster.
English: No serious vaccine-related adverse experiences were reported.
Danish: Der blev ikke rapporteret alvorlige, vaccine-relaterede bivirkninger.
English: Necrotizing retinitis (patients on immunosuppressive therapy)
Danish: Nekrotiserende retinitis (patienter, som gennemgår immunsuppressiv terapi)
English: Table 5: Reduction of the zoster-associated pain by the BOI
Danish: Tabel 5: Reduktion af zoster-relaterede smerter målt ved hjælp af BOI
English: When evaluated at 4 weeks post-vaccination, the immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier frozen formulation of ZOSTAVAX.
Danish: Ved evaluering 4 uger efter vaccination blev det påvist, at immunogeniciteten af den aktuelle køleskabsstabile formulering svarede til immunogeniciteten af den tidligere frosne formulering af ZOSTAVAX.
English: See sections 4.3 and 4.4.
Danish: 4.3 og 4.4.
English: Final determination of zoster cases was made by Polymerase Chain Reaction (PCR) [86%], or in the absence of virus detection, as determined by a clinical evaluation committee [14%].
Danish: Den endelige påvisning af zoster-tilfælde blev foretaget ved hjælp af polymerasekædereaktion (PCR) [86 %] eller - hvis virus ikke kunne påvises - i henhold til den kliniske bedømmelseskomites vurdering [14 %].
English: However, a history of contact dermatitis due to neomycin is not a contraindication to receiving live virus vaccines.
Danish: Dog er en anamnese med kontaktallergi forårsaget af neomycin ikke en kontraindikation for vaccinationer med levende virus.
English: Neomycin allergy generally manifests as a contact dermatitis.
Danish: Neomycinallergi ses generelt i form af kontaktdermatitis.
English: The adjusted hazard ratio comparing the incidence rate of HZ in the two groups was 1.04 (95% CI, 0.92, 1.16) over a median follow-up of 4.7 years.
Danish: Den justerede hazard ratio, der sammenligner incidensraten for HZ i de to grupper, var 1,04 (95% CI, 0,92; 1,16) i løbet af en median opfølgningsperiode på 4,7 år.
English: Subcutaneous or intramuscular use.
Danish: Til subkutan eller intramuskulær brug.
English: In the STPS, there were 84 evaluable zoster cases [8.4/1,000 person-years] in the ZOSTAVAX group and 95 evaluable cases [14.0/1,000 person-years] in the placebo group.
Danish: I STPS var der 84 evaluerbare zostertilfælde [8,4/1000 person-år] i ZOSTAVAX-gruppen og 95 evaluerbare tilfælde [14,0/1000 person-år] i placebogruppen.
English: ZOSTAVAX can be administered at the same time as inactivated influenza vaccine.
Danish: ZOSTAVAX kan indgives parallelt med inaktiveret influenzavaccine.
English: Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Danish: Fremstiller: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Holland
English: Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics (SmPC).
Danish: Der er ikke foretaget traditionelle prækliniske studier, men ingen prækliniske forhold er vurderet relevante for den kliniske sikkerhed ud over data, der er inkluderet under andre punkter i dette produktresumé.
English: After you have had chickenpox, the virus that caused it stays in your body in nerve cells.
Danish: Når man har haft skoldkopper, bliver den virus, som var skyld i sygdommen, i kroppen i nervecellerne.
English: Solicited adverse reaction within 5 days post-vaccination.
Danish: Bivirkning rapporteret ved udspørgning inden for 5 dage efter vaccination.
English: The risk of transmitting the attenuated vaccine virus from a vaccinee to a susceptible contact should be weighed against the risk of developing natural zoster and potentially transmitting wild-type VZV to a susceptible contact.
Danish: Risikoen for at overføre attenueret vaccinevirus fra en vaccineret person til en modtagelig kontakt skal ses i forhold til risikoen for at udvikle naturlig infektion med herpes zoster og potentielt overføre vildtype-VZV til en modtagelig kontakt.
English: • if you have active untreated tuberculosis
Danish: • hvis De har aktiv tuberkulose, der ikke behandles
English: † The zoster pain BOI score is a composite score that incorporates the incidence, severity, and duration of acute and chronic zoster-associated pain over a 6 month follow-up period.
Danish: † BOI-score ved zostersmerter er en sammensat score, hvor der indgår incidensen, sværhedsgraden og varigheden af akutte og kroniske zoster-relaterede smerter i løbet af en 6 måneders opfølgningsperiode.
English: The concomitant use of ZOSTAVAX and a 23-valent pneumococcal polysaccharide vaccine resulted in reduced immunogenicity of ZOSTAVAX in a small clinical trial.
Danish: Samtidig brug af ZOSTAVAX og en 23-valent pneumokokpolysaccharidvaccine har resulteret i reduceret immunogenicitet af ZOSTAVAX i et mindre klinisk studie.
English: It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
Danish: Det er vigtigt at anvende en ny steril sprøjte og kanyle til hver patient for at forhindre smitteoverførsel mellem patienter.
English: What you need to know before you receive ZOSTAVAX
Danish: Det skal De vide, før De får ZOSTAVAX
English: VE against PHN was evaluated for up to eight years postvaccination.
Danish: VE mod PHN blev evalueret i op til 8 år efter vaccination.
English: *The analysis was performed on the intent-to-treat (ITT) population that included all subjects randomised in the ZEST study
Danish: * Analysen blev udført på intent-to-treat (ITT) populationen, der omfattede alle randomiserede forsøgspersoner i ZEST-studiet
English: Most of the reporting rashes that were VZV positive by PCR analysis were associated with wild-type VZV.
Danish: De fleste af de rapporterede VZV-positive udslæt (påvist ved hjælp af PCR-analyse) var forbundet med vildtype VZV.
English: • Pregnancy.
Danish: • Graviditet.
English: The needle should be pushed into the extremity of the syringe and rotated a quarter of a turn (90) to secure the connection.
Danish: Kanylen skal skubbes helt ind i sprøjten og drejes en kvart omdrejning (90) for at sikre sammenkoblingen.
English: Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination.
Danish: Kvinder i den fødedygtige alder skal tage nødvendige forholdsregler for at undgå graviditet i 1 måned efter vaccination.
English: This effect was more prominent in the group of older subjects (≥70 years of age), where the risk of developing PHN after zoster was reduced to 10% in the vaccine group vs. 19% for the placebo group.
Danish: Denne effekt var mere fremtrædende i gruppen af ældre patienter (≥70 år), hvor risikoen for at få PHN efter zoster blev reduceret til 10 % i vaccinegruppen mod 19 % i placebogruppen.
English: 3-year postvaccination 5-year postvaccination
Danish: 3 år efter vaccination 5 år efter vaccination
English: Within SPS, immune responses to vaccination were evaluated in a subset of the enrolled subjects (N=1395).
Danish: I SPS blev immunresponser på vaccinen evalueret i en undergruppe af patienter i studiet (N=1395).
English: ZOSTAVAX contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: ZOSTAVAX indeholder natrium ZOSTAVAX indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er stort set natriumfrit.
English: The number of subjects who reported varicella/varicella-like rashes was less than 0.7% for ZOSTAVAX and placebo.
Danish: Antallet af forsøgspersoner, der rapporterede varicella/varicella-lignende udslæt, var under 0,7 % for ZOSTAVAX og placebo.
English: However naturally-occurring varicella-zoster virus infection is known to sometimes cause foetal harm.
Danish: Det vides dog, at naturligt opstået varicellazostervirusinfektion undertiden kan forårsage føtale skader.
English: ZOSTAVAX is a live, attenuated varicella-zoster vaccine and administration to individuals who are immunosuppressed or immunodeficient may result in disseminated varicella-zoster virus disease, including fatal outcomes.
Danish: ZOSTAVAX er en levende, svækket Varicella-zoster vaccine, og administration til personer, som lider af immunsuppression eller en immundefekt, kan medføre dissemineret varicella-zoster-virussygdom, inklusive dødelige tilfælde.
English: In the vaccine group, the risk of developing PHN after zoster was 9 % (27/315), while in the placebo group it was 13 % (80/642).
Danish: I vaccinegruppen var risikoen for at få PHN efter zoster 9 % (27/315) mens den var 13 % i placebogruppen (80/642).
English: This vaccine should be given subcutaneously to individuals with severe thrombocytopenia or any coagulation disorder, because these individuals may bleed following intramuscular injections.
Danish: Denne vaccine skal gives subkutant til personer med svær trombocytopeni eller andre koagulationssygdomme, da disse personer er i risiko for at få blødning efter intramuskulære injektioner.
English: ZOSTAVAX was shown to boost VZV-specific immunity, which is thought to be the mechanism by which it protects against zoster and its complications (See Immunogenicity).
Danish: ZOSTAVAX er blevet vist at fremme VZV-specifik immunitet, hvilket menes at være mekanismen med hvilken vaccinen beskytter imod herpes zoster og imod de relaterede komplikationer (se Immunogenicitet).
English: During the course of the STPS, placebo recipients were offered ZOSTAVAX, at which time they were considered to have completed the STPS.
Danish: I forløbet af STPS blev placebo-vaccinerede forsøgsdeltagere tilbudt ZOSTAVAX, og de blev på det tidspunkt betragtet som havende fuldført STPS.
English: Immunogenicity of ZOSTAVAX
Danish: Immunogenicitet af ZOSTAVAX
English: Most of these local and systemic adverse reactions were reported as mild in intensity.
Danish: De fleste af disse lokale og systemiske bivirkninger blev rapporteret som værende af mild sværhedsgrad.
English: - This vaccine has been prescribed for you only.
Danish: Lægen har ordineret denne vaccine til Dem personligt.
English: Age at vaccination* 50-59 years 60-69 years 70-79 years 80+ years Among all age groups
Danish: Alder på vaccinationstidspunktet* 50-59 år 60-69 år 70-79 år 80+ år I alle aldersgrupper VE % (95% CI)
English: Administration of a higher than recommended dose of ZOSTAVAX was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of ZOSTAVAX.
Danish: Indgivelse af en højere dosis ZOSTAVAX end den anbefalede blev rapporteret sjældent, og bivirkningsprofilen var sammenlignelig med, hvad der blev observeret med den anbefalede dosis af ZOSTAVAX.
English: The STPS was initiated to accrue additional information on the persistence of vaccine efficacy for subjects who received ZOSTAVAX in SPS.
Danish: STPS blev initieret for at få mere information om varigheden af vaccinens effekt hos de forsøgspersoner i SPS, der fik ZOSTAVAX.
English: However, ZOSTAVAX is expected to have no or negligible influence on ability to drive and use machines.
Danish: ZOSTAVAX forventes dog ikke at have nogen eller ubetydelig indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.
Danish: Der foreligger ingen oplysninger, som antyder, at ZOSTAVAX påvirker evnen til at køre bil eller betjene maskiner.