natgillin/translations-raw huggingface dataset:
Generaliserede hudreaktioner, herunder kløe, nældefeber og uspecifikt udslæt
Generalised skin reactions including pruritus, urticaria or non-specific rash.
Sjælden (> 1/ 10. 000, < 1/ 1. 000):
Rare (> 1/ 10,000, < 1/ 1,000):
Der er rapporter om allergiske reaktioner, som i sjældne tilfælde har ført til chok.
Allergic reactions, in rare cases leading to shock, have been reported.
Meget sjælden (< 1/ 10. 000):
Very rare (< 1/ 10,000):
Neurologiske forstyrrelser, såsom encefalomyelitis, nervebetændelse og Guillain Barré- syndrom.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Endnu ingen registreret.
Adverse event(s) from post-marketing surveillance with the pandemic vaccine: not applicable.
Farmakoterapeutisk klassifikation:
Influenza vaccine, ATC Code:
Influenzavaccine, ATC- kode J07BB02
J07BB02
4 Dette afsnit beskriver den kliniske erfaring med mock- up- vaccinerne efter administrering af to doser.
This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
Mock- up- vacciner indeholder influenza- antigener, som er anderledes end antigenerne i de aktuelt cirkulerende influenza- vira.
Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Disse antigener kan betragtes som ’ nye ’ antigener og simulerer en situation, hvor målpopulationen for vaccination er immunologisk naive.
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the 4 target population for vaccination is immunologically naïve.
Data indhentet med en mock - up- vaccine vil understøtte en vaccinationsstrategi, der sandsynligvis vil blive anvendt med den pandemiske vaccine: data vedrørende klinisk effekt og sikkerhed af mock- up- vacciner er relevante for pandemi - vacciner.
Data obtained with a mock-up vaccine will support a vaccination strategy that is likely to be used for the pandemic vaccine: clinical efficacy and safety data obtained with mock-up vaccines are relevant for the pandemic vaccines.
Der blev udført et klinisk studie med en H5N1- vaccine kombineret med MF59C. 1- adjuvans med 486 raske, voksne frivillige.
A clinical trial was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 486 healthy adult volunteers.
Der blev med tre ugers interval givet to doser vaccine, som indeholdt H5N1 (A/ Vietnam/ 1194/ 2004) i 2 forskellige styrker (7, 5 og 15 µg hæmagglutinin [HA] / dosis) med MF59C. 1- adjuvans.
Two doses of vaccine containing H5N1 (A/ Vietnam/ 1194/ 2004) at 2 different dosages (7.5 and 15 µg hemagglutinin [HA]/ dose) with MF59C.1 adjuvant were administered three weeks apart.
Serumbeskyttelse *, konvertering * og konverteringsfaktor ** for anti- HA antistof hos voksne målt med SRH var som følger:
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody in the adults measured by SRH were as follows:
anti- HA antistof
anti-HA antibody
22 dage efter 1. dosis
22 days after 1st dose
Serumbeskyttelse i% Konvertering i% Konverteringsfaktor ** * målt med SRH- assay ≥ 25 mm
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
31- 47) 2, 42 (2. 02- 2, 89)
31-47) 2.42 (2.02-2.89)
Serumbeskyttelse *, konvertering * og konverteringsfaktor ** for anti- HA antistof hos probander over 60 år målt med SRH- assay var som følger:
The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Serumbeskyttelse i% Konvertering i% Konverteringsfaktor ** målt med SRH- assay ≥ 25 mm
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
Antistoffernes holdbarhed varierer ved mock- up- vaccinerne.
The persistence of antibodies for the mock-up vaccines varies.
Med de interpandemiske, trivalente vacciner er den som regel 6- 12 måneder, men for denne vaccine foreligger der endnu ingen data med H5N1- stammen.
With the interpandemic trivalent vaccines it is usually 6-12 months, but for this vaccine no data are available yet with the H5N1 strain.
• Understøttende studier
• Supportive Studies
I to “ dose- finding ” - studier modtog 78 voksne en adjuveret mock- up- vaccine (H5N3 eller H9N2).
In two dose finding studies 78 adults received an adjuvanted mock-up vaccine (H5N3 or H9N2).
Der blev administreret to doser vaccine med H5N3- stammen (A/ Duck/ Singapore/ 97) i 3 forskellige styrker (7, 5; 15 og 30 µg HA/ dosis) med tre ugers mellemrum.
Two doses of vaccine with H5N3 (A/ Duck/ Singapore/ 97) strain at 3 different dosages (7.5, 15 and 30 µg HA/ dose) were administered three weeks apart.
Serumprøver blev testet mod den originale H5N3 og også et antal H5N1- isolater.
Serum samples were tested against the original H5N3 and also a number of H5N1 isolates.
Serologisk respons målt med SRH- assay viste, at 100% af de vaccinerede opnåede serumbeskyttelse, og at 100% serokonverterede efter to injektioner med 7, 5 µg.
Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 μ g injections.
Desuden blev det konstateret, at den adjuverede vaccine inducerede antistoffer, der krydsbeskyttede mod de H5N1- stammer, som blev isoleret i 2003 og 2004, som udviser antigen drift sammenlignet med de originale stammer.
The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Der blev administreret to doser vaccine, som indeholdt H9N2- stammen (A/ chicken/ Hong Kong/ G9/ 97) i 4 forskellige styrker (3, 75; 7, 5; 15 og 30 µg HA/ dosis) med fire ugers mellemrum.
Two doses of vaccine containing H9N2 (A/ chicken/ Hong Kong/ G9/ 97) strain at 4 different dosages (3.75, 7.5, 15 and 30 µg HA/ dose), were administered four weeks apart.
Serologisk respons målt med Hæmagglutination- Inhibition - (HI) - assay viste, at 92% af de vaccinerede opnåede serumbeskyttelse, og 75% serokonverterede efter to injektioner med 7, 5 µg.
Serologic responses obtained with the Hemagglutination Inhibition (HI) assay showed that 92% of subjects achieved seroprotection and 75% seroconverted after two 7.5 μ g injections.
Focetria er godkendt under ” særlige omstændigheder ”.
Focetria has been authorised under “ Exceptional Circumstances”.
5 Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel af videnskabelige årsager.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Ingen oplysninger.
5 Not applicable.
Natriumchlorid, Kaliumchlorid, Kaliumdihydrogenfosfat, Dinatriumfosfatdihydrat, Magnesiumchloridhexahydrat, Calciumchloriddihydrat, Natriumcitrat, Citronsyre, Vand til injektionsvæsker.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate, Citric acid, Water for injections.
0, 5 ml i fyldt injektionssprøjte (type I- glas) med stempelprop (bromobutylgummi).
0.5 ml in pre-filled syringe (type I glass) with plunger-stopper (bromo-butyl rubber).
Ikke anvendt vaccine samt affald heraf bør destrueres i henhold til lokale retningslinier.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italien.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Pandemisk influenzavaccine (overfladeantigen, inaktiveret, adjuveret)
Focetria suspension for injection Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
8 4. 3 Kontraindikationer
8 4.3 Contraindications
9 let forøget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke - adjuverede influenzavacciner.
It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
5. 1 for yderligere information om mock- up vacciner).
9 Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
10 Dette afsnit beskriver den kliniske erfaring med mock- up- vaccinerne efter administrering af to doser.
This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
Disse antigener kan betragtes som ’ nye ’ antigener og simulerer en situation, hvor målpopulationen for vaccination er immunologisk naive.
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the 10 target population for vaccination is immunologically naïve.
Serumbeskyttelse *, konvertering * og konverteringsfaktor ** for anti- HA antistof hos probander over 60 år målt med SRH- assay var som følger:
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
11 Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel af videnskabelige årsager.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Ingen oplysninger.
11 Not applicable.
0, 5 ml i enkeltdosis hætteglas (type I- glas) med prop (halobutylgummi).
0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber).
Pakninger med 10 Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all pack sizes may be marketed.
12 Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italien.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
Focetria injektionsvæske, suspension i flerdosisbeholder
Focetria suspension for injection in multidose container Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
0, 5 ml dosis
7.5 micrograms ** per 0.5 ml dose
Adjuvans MF59C. 1, som indeholder: squalen polysorbat 80 sorbitantrioleat
polysorbate 80 sorbitan trioleate Excipients:
9, 75 milligram 1, 175 milligram 1, 175 milligram
1.175 milligrams 1.175 milligrams
0, 05 milligram
0.05 milligrams
6. 5 vedrørende antal doser pr. hætteglas
See section 6.5 for the number of doses per vial.
Denne vaccine opfylder WHO’ s anbefalinger og EU’ s bestemmelser for pandemien.
This vaccine complies with the WHO recommendations and EU decision for the pandemic.
14 Sundhedspersonalet skal derfor vurdere fordele og eventuelle risici ved administration af vaccinen til denne population.
14 For pregnant women, see section 4.6.
Der bør udvises forsigtighed, når denne vaccine gives til personer med kendt overfølsomhed (ud over anafylaktiske reaktioner) over for det aktive stof, over for et eller flere af hjælpestofferne, thiomersal over for æg, kyllingeproteiner, kanamycin - og neomycinsulfat, formaldehyd og cetyltrimethylammoniumbromid (CTAB).
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB).
• Kliniske studier
4.8 Undesirable effects
15 I kliniske studier med forskellige formuleringer (H5N3, H9N2 og H5N1) fik 542 personer kandidatvaccinen.
• Clinical trials In clinical trials with different formulations (H5N3, H9N2 and H5N1) 542 subjects were exposed to thecandidate vaccine.
I de kliniske studier med pandemivaccinen var de fleste reaktioner lette, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson- influenzavacciner.
It is widely
Det er almindeligt accepteret, at adjuvanteffekten, som medfører øget immunogenicitet, er forbundet med en let forøget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke - adjuverede influenzavacciner.
15 accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
5. 1 for yderligere information om mock- up vacciner).
Adverse reactions from clinical trials with the mock-up vaccine are listed below (see section 5.1 for more information on mock-up vaccines).
4. 4).
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
16 Der er ikke rapporteret tilfælde af overdosering.
No case of overdose has been reported.
5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties 16 Pharmacotherapeutic group:
Dette afsnit beskriver den kliniske erfaring med mock- up- vaccinerne efter administrering af to doser.
This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
Disse antigener kan betragtes som ’ nye ’ antigener og simulerer en situation, hvor målpopulationen for vaccination er immunologisk naive.
These antigens can be considered as ‘ novel’ antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Serumbeskyttelse *, konvertering * og konverteringsfaktor ** for anti- HA antistof hos voksne målt med SRH var som følger:
The seroprotection rate* seroconversion rate* and the seroconversion factor ** for anti-HA antibody in the adults measured by SRH were as follows:
Serumbeskyttelse *, konvertering * og konverteringsfaktor ** for anti- HA antistof hos probander over 60 år målt med SRH- assay var som følger:
The seroprotection rate* seroconversion rate* and the seroconversion factor ** for anti-HA antibody in subjects aged over 60 measured by SRH were as follows:
Serumbeskyttelse i% Konvertering i% Konverteringsfaktor ** målt med SRH- assay ≥25 mm
Seroprotection rate Seroconversion rate Seroconversion factor * measured by SRH assay ≥ 25 mm ** geometric mean ratios of SRH
Desuden blev det konstateret, at den
Serologic responses obtained with the SRH assay showed that 100% of subjects achieved seroprotection and 100% seroconverted after two 7.5 μ g injections.
17 adjuverede vaccine inducerede antistoffer, der krydsbeskyttede mod de H5N1- stammer, som blev isoleret i 2003 og 2004, som udviser antigen drift sammenlignet med de originale stammer.
The adjuvanted vaccine was also found to induce antibodies that cross-protected against the H5N1 strains isolated in 2003 and 2004, which exhibit some antigenic drift compared to the original strains.
Focetria er godkendt under ” særlige omstændigheder ”.
17 Focetria has been authorised under “ Exceptional Circumstances”.
Natriumchlorid, Kaliumchlorid, Kaliumdihydrogenfosfat, Dinatriumfosfatdihydrat, Magnesiumchloridhexahydrat, Calciumchloriddihydrat, Natriumcitrat, Citronsyre, Thiomersal, Vand til injektionsvæsker.
Sodium chloride, Potassium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium citrate, Citric acid, Thiomersal, Water for injections.
5, 0 ml i 10- dosis hætteglas (type I- glas) med prop (halobutylgummi).
5.0 ml in 10-dose vial (type I glass) with stopper (halo-butyl rubber).
18 Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all pack sizes may be marketed.
Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italien.
MARKETING AUTHORISATION HOLDER 18 Novartis Vaccines and Diagnostics S. r. l. - Via Fiorentina, 1 – Siena, Italy.
(Fremstiller ansvarlig for monovalente, poolede høster, inden endelig filtrering):
(Manufacturer responsible for monovalent pooled harvests, before final filtration):
(Fremstiller ansvarlig for endelig filtrering af monovalent pooled høst):
(Manufacturer responsible for final filtration of monovalent pooled harvest):
Bellaria – 53018 Rosia – Sociville (SI) Italien
Bellaria – 53018 Rosia – Sociville (SI) Italy
Focetria må kun markedsføres, når WHO/ EU officielt har erklæret, at der er en influenza- pandemi og på betingelse af, at indehaveren af markedsføringstilladelsen til Focetria tager behørig hensyn til den officielt erklærede pandemi- stamme.
Focetria can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Focetria takes due account of the officially declared pandemic strain.
Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/ 83/ EØF, med ændringer vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Indehaveren af markedsføringstilladelsen skal sikre, at et pharmacovigilance- system er på plads og i funktion, før produktet markedsføres, og så længe som det markedsførte produkt anvendes.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Indsendelse af “ periodic safety update ” - rapporter (PSUR) under influenza- pandemien:
PSUR submission during the influenza pandemic:
I en pandemisk situation, er hyppigheden af indsendelse af “ periodic safety update ” - rapporter, som anført i artikel 24 i forordning (EF) nr.
Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
726/ 2004, ikke tilstrækkelig til overvågning af sikkerheden af en pandemisk vaccine, for hvilken høje eksponeringsniveauer forventes inden for en kort tidsperiode.
Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be
Sådanne situationer kræver hurtig meddelelse om sikkerhedsoplysninger, som kan have de største implikationer for balancen i risk - 21 benefitforholdet under en pandemi.
21 vaccinated.
Desuden er de nødvendige ressourcer til en dybdegående vurdering af “ periodic safety update ” - rapporter i det omfang, der er defineret i volume 9a i bekendtgørelsen ’ Rules Governing Medicinal Product in the European Union ’, muligvis ikke tilstrækkelig under en pandemi til hurtigt at kunne identificere nye sikkerhedsproblemer.
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue.
Derfor skal indehaveren af markedsføringstilladelsen, så snart pandemien er erklæret (Fase 6 af WHO’ s globale beredskabsplan for influenza) og pandemi- vaccinen anvendes, indsende “ periodic safety update ” - rapporter med nedenstående frekvens og omfang:
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Indsendelseshyppighed
Frequency of submission
- Uret nulstilles fra den første mandag efter afsendelse af den første batch vaccine.
- The clock will start from the first Monday after shipment of the first batch of vaccine.
- Første “ data- lock point ” er 14 dage senere.
- First data-lock point is 14 days later.
- Indsendelse af rapporten skal ske senest på dag 22 (dvs. den efterfølgende mandag).
- Report submission is no later than day 22 (i. e. the following Monday).
- Rapportering skal ske hver 14. dag i de første 3 måneder af pandemien.
- Reporting to be fortnightly for the first 3 months of the pandemic.
- Frekvensen tages op til overvejelse af indehaveren af markedføringstilladelsen og (co -)
- Periodicity will be reviewed by the MAH and the (Co-)Rapporteur at 3 monthly intervals.
rapporteur hver 3. måned.
Format The report shall include the following Tables of aggregate data using the agreed templates:
Dødelige og/ eller livstruende reaktioner for hver foretrukket term (Preferred Term eller PT), herunder andelen af rapporteringer om dødelighed 2.
Fatal and/ or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports
Bivirkninger af særlig interesse (PT’ er) 3.
4.
Alle bivirkninger, som forekommer hos følgende aldersgrupper:
Adverse Events of Special Interest (PTs) Serious unexpected reactions (PTs) All events occurring in the following age groups:
6- 23 måneder, 2- 8 år, 8- 17 år, 18- 60 år, > 60 år Alle bivirkninger som forekommer hos gravide kvinder 5.
6-23 months, 2-8 years, 8-17 years, 18-60 years, > 60 years All events occurring in pregnant women
En samlet oversigt over alle bivirkninger i løbet af perioden, inddelt ifølge typen af rapporterende person (patient eller sundhedspersonale), bivirkningernes alvorlighed, forventethed, samt hvorvidt de er spontane eller fremkaldte.
All events reported by patients that have been entered into the database by data-lock point A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Fremlæggelse af dokumentation skal tage følgende anbefalinger i betragtning:
Presentation of data will take into consideration the following recommendations:
- Alvorlige forventede reaktioner skal gennemgås af indehaveren af markedsføringstilladelsen
- Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures
som led i deres procedurer for detektering af resultater, og skal kun inkluderes i rapporten, hvis der opstår et sikkerhedsproblem.
and will only form part of the report if an issue of concern arises.
- Alle tabeller skal baseres på antal bivirkninger (fremlagt på PT- niveau og inddelt efter
- All tables will be based on number of events (presented on PT level, sorted by System Organ Class
systemorganklasse [SOC]) og ikke efter antallet af tilfælde.
[SOC]) and not number of cases.
- Tabel 1 - 4 skal baseres på bivirkninger, som udelukkende er rapporteret af sundhedspersonale.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
- Tabel 1 - 5 skal oplyse antallet af bivirkninger, som blev modtaget i løbet af
- In Tables 1 to 5, numbers will be provided for events received during the reporting period and
rapporteringsperioden og sammenlagt.
cumulatively.
- Alle tabeller skal baseres på generisk og ikke produktspecifik dokumentation.
- All tables will be based on generic and not product-specific data.
Produktspecifik
Product-specific data can be
dokumentation kan medtages i vurderingen om detektering af resulater.
evaluated during signal work-up.
Disse kan om nødvendigt gives i rapporter over resultater.
- No line listings are required – these can be provided in signal evaluation reports as necessary.
Der skal gives en opsummering sammen med “ periodic safety update ” - rapporterne, i hvilken ethvert område, der er årsag til bekymring, skal fremhæves, vurderingen om resultater skal prioriteres (i tilfælde af flere resultater), og passende tidsrammer for indsendelse af en fuldstændig udredende rapport skal gives.
A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (in the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Alle udredende rapporter om resultater skal indsendes, herunder også rapporter om resultater, som senere ikke blev identificeret som værende resultater.
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.