natgillin/translations-raw huggingface dataset:
Lægemiddelovervågningssystem Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet, som beskrevet i version V03 (dateret 19. november 2007) i Modul 1. 8. 1 i ansøgningsmaterialet til markedsføringstillladelsen, er på plads og fungerer, før produktet når markedet, og så længe produktet markedsføres.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version V03 (dated 19 November 2007) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Risikohåndteringsplan Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og lægemiddelovervågningsaktiviteter, der er beskrevet i lægemiddelovervågningsplanen (RMP), som aftalt i version RMPv4 (dateret april 2008) af Risikohåndteringsplanen (RMP) anført i modul 1. 8. 2. i ansøgningen om markedføringstilladelsen, og i efterfølgende CHMP- krav til opdateringer af RMP.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv4 (dated April 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Som angivet i CHMP’ s retningslinjer for risikohånteringssystemer til humane lægemidler, skal den opdaterede RMP indsendes samtidig med den næste periodiske sikkerhedsopdatering (Periodic Safety Update Report, PSUR)
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Yderligere skal der indsendes en opdateret RMP: • når der modtages ny information, der kan have indflydelse på den nuværende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter • inden for 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering) • på anmodning fra EMEA.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
11 PSUR
11 Outside of the pandemic period, the normal PSUR periodicity and format will be maintained.
Indsendelse af PSUR når Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram administreres under en influenzapandemi:
PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
726/ 2004 ikke relevant i forbindelse med sikkerhedsmonitorering af en pandemisk vaccine, hvor patienterne forventes at blive udsat for høj eksponering i løbet af kort tid.
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/ 2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Som en konsekvens heraf skal indehaveren af markedsføringstilladelsen indsende regelmæssige PSUR på nedennævnte tidspunkter og i nedenfor anførte format, så snart pandemien er erklæret (fase 6 i WHO’ s beredskabsplan for verdensomspændende influenza) og præpandemivaccinen anvendt.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the prepandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
- Uret startes fra den første mandag efter datoen for erklæringen om en pandemisk
- The clock will start from the first Monday after the date of announcement of the
influenza (fase 6 i WHO’ s beredskabsplan) (dag 0)
influenza pandemic (Phase 6 of the WHO Preparedness Plan) (Day 0)
- Første data- lock- point er 14 dage senere.
- First data-lock point is 14 days later.
Alle hændelser, som patienterne har rapporteret, og som er lagt ind i databasen på tidspunktet for data- lock- point.
All events reported by patients that have been entered into the database by data-lock point 6.
Alvorlige, forventede reaktioner vurderes af indehaveren af markedsføringstilladelsen som en del af evalueringsprocedurerne og vil kun indgår i rapporten, hvis et alvorligt tilfælde opstår.
detection procedures and will only form part of the report if an issue of concern arises.
Alle tabeller baseres på antal hændelser (med foretrukket term, opført efter organklasser (SOC)) og ikke antal tilfælde.
- All tables will be based on number of events (presented on PT level, sorted by System
- - -
Organ Class [SOC]) and not number of cases.
Tabel 1- 4 omfatter kun hændelser, som er rapporteret af sundhedspersonalet.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
I tabel 1- 5 vises antal hændelser i rapporteringsperioden og kumulativt.
- In Tables 1 to 5, numbers will be provided for events received during the reporting
Alle tabeller baseres på generiske og ikke på produktspecifikke data.
period and cumulatively.
Produktspecifikke data kan vurderes i udredningen af signaler.
- All tables will be based on generic and not product-specific data.
Der kræves ingen ” line listings ” evalueringsrapporterne over signalerne.
- No line listings are required – these can be provided in signal evaluation reports as
disse
necessary.
kan
All signal evaluation reports should be provided, including those that were subsequently not identified as being signals.
angives
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
behov
i) ii) iii)
Alle vurderingsrapporter over signalerne skal angives inkl. dem, der efterfølgende ikke blev identificeret som signaler.
EU member states for the reporting period by batch number, EU member states cumulatively and the rest of the world
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
A/ VietNam/ 1194/ 2004 (H5N1) - lignende stamme (NIBRG- 14)
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14)
3, 75 mikrogram *
3.75 micrograms*
AS03- adjuvans bestående af squalen (10, 68 mg), DL- α- tocopherol (11, 86 mg) og polysorbat 80 (4, 85 mg) * hæmagglutinin
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams) * haemagglutinin
50 hætteglas: suspension 25 hætteglas x 2: emulsion
50 vials: suspension 25 vials x 2: emulsion
Ved sammenblanding af 1 hætteglas suspension (2, 5 ml) og 1 hætteglas emulsion (2, 5 ml) fås 10 vaccinedoser (5 ml).
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)
1 dosis = 0, 5 ml
1 dose = 0.5 ml
16 Intramuskulær anvendelse Omrystes før brug Læs indlægssedlen inden brug.
METHOD AND ROUTE(S) OF ADMINISTRATION
Opbevares i køleskab Må ikke fryses Opbevares i den originale yderpakning for at beskytte mod lys
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Rue de l’ Institut 89 B- 1330 Rixensart Belgien
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
Prepandemisk influenzavaccine (H5N1)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection Prepandemic influenza vaccine (H5N1)
Split influenzavirus, inaktiveret, indeholdende antigen svarende til A/ VietNam/ 1194/ 2004 (H5N1) - lignende stamme (NIBRG- 14) * hæmagglutinin
Split influenza virus, inactivated, containing antigen equivalent to A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * haemagglutinin
Intramuskulær anvendelse Omrystes før brug Læs indlægssedlen inden brug
Intramuscular use Shake before use Read the package leaflet before use
19 Suspension til sammenblanding med emulsion før administration.
OTHER SPECIAL WARNING(S), IF NECESSARY
Emulsion til injektionsvæske, emulsion
Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
22 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER SUSPENSION HÆTTEGLAS
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL
Hætteglas A Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram suspension til injektionsvæske, emulsion. i. m.
Vial A Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
EXP Efter rekonstitution:
EXP After mixing:
Anvendes inden for 24 timer og må ikke opbevares over 25 °C.
Use within 24 hours and do not store above 25°C.
10 doser (2, 5 ml)
10 doses (2.5 ml)
23 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER EMULSION HÆTTEGLAS
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS EMULSION VIAL
Hætteglas B Emulsion til injektionsvæske, emulsion i. m.
Vial B Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg IM
25 INDLÆGSSEDDEL INFORMATION TIL BRUGEREN Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram suspension og emulsion til injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Læs denne indlægsseddel grundigt, inden du begynder at tage denne vaccine.
Read all of this leaflet carefully before you start receiving this vaccine.
- Lægen har ordineret Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret,
- This vaccine has been prescribed for you.
adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram til dig personligt.
Do not pass it on to others.
Virkningen af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram og hvad du skal bruge det til 2.
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for 2.
Det skal du vide, før du tager Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram 3.
Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 3.
Sådan anvendes Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram 4.
How Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is given 4.
Sådan opbevares Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram 6.
How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 6.
VIRKNINGEN AF PREPANDEMISK INFLUENZAVACCINE (H5N1) (SPLIT VIRION, INAKTIVERET, ADJUVERET) GLAXOSMITHKLINE BIOLOGICALS 3, 75 MIKROGRAM OG HVAD DU SKAL BRUGE DET TIL
WHAT PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg IS AND WHAT IT IS USED FOR
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram er en vaccine, som anvendes til voksne i alderen fra 18 til 60 år.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is a vaccine for use in adults from 18 to 60 years old.
Når en person vaccineres, danner immunsystemet (kroppens naturlige forsvarsmekanisme) sin egen beskyttelse (antistoffer) mod sygdommen.
When a person is given the vaccine, the immune system (the body’ s natural defence system) will produce its own protection (antibodies) against the disease.
Som ved alle andre vacciner vil ikke alle vaccinerede personer være fuldstændig beskyttet mod infektion.
As with all vaccines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg may not fully protect all persons who are vaccinated.
DET SKAL DU VIDE, FØR DU TAGER PREPANDEMISK INFLUENZAVACCINE (H5N1) (SPLIT VIRION, INAKTIVERET, ADJUVERET) GLAXOSMITHKLINE BIOLOGICALS 3, 75 MIKROGRAM
BEFORE YOU RECEIVE PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg
Anvend ikke Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram:
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should not be given:
26 • hvis du tidligere har haft en pludselig, livstruende, overfølsomhedsreaktion mod et af indholdsstofferne i Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram (disse er anført sidst i denne indlægsseddel) eller over for et af følgende stoffer, som muligvis kan findes i sporstofmængder: æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat (antibiotikum) eller natriumdeoxycholat.
26 gentamicin sulphate (antibiotic) or sodium deoxycholate.
Tegn på en allergisk reaktion kan være kløende hududslæt, stakåndethed og opsvulmet ansigt eller tunge. • hvis du har en alvorlig infektion med høj feber (over 38 °C).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
En mindre infektion, fx forkølelse, er normalt ikke noget problem, men lægen afgør, om du kan vaccineres med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram.
A minor infection such as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Vær ekstra forsigtig med at anvende Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram:
Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
• hvis du har haft andre overfølsomhedsreaktioner end den pludselige, livstruende overfølsomhedsreaktion, over for et af indholdsstofferne i vaccinen, thiomersal, æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat (antibiotikum) eller natriumdeoxycholat (se afsnit 6, der giver yderligere oplysninger) • hvis du har nedsat immunforsvar, da virkningen af vaccinen så kan være nedsat • hvis du skal have taget en blodprøve for at fastslå en infektion forårsaget af bestemte vira.
Further information). • if you have problems with your immune system, since your response to the vaccine may then be poor. • if you are having a blood test to look for evidence of infection with certain viruses.
En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram.
In the first few weeks after vaccination with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg the results of these tests may not be correct.
Fortæl til lægen, som har bedt om at få sådanne blodprøver foretaget, at du for nyligt har fået Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram.
Tell the doctor requesting these tests that you have recently received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Dette gælder også andre vacciner og medicin, som ikke er købt på recept.
Using other medicines or vaccines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Der findes ingen oplysninger om samtidig brug af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram og andre vacciner.
There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram bør derfor ikke gives samtidig med andre vacciner.
Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
Hvis du tager medicin, som nedsætter immunforsvaret, eller får en anden behandling (fx strålebehandling), som påvirker immunforsvaret, kan Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram stadig gives, men virkningen af vaccinen kan være nedsat.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can still be given but your response to the vaccine may be poor.
Der findes ingen oplysninger om brugen af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram til gravide eller ammende kvinder.
Pregnancy and breast-feeding There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Hvis du er gravid, forsøger at blive gravid eller ammer, fortæl det til lægen,
Please tell your doctor if you are/ may be pregnant or intend to become pregnant, or if you are breast-feeding and follow his advice.
Trafik - og arbejdssikkerhed Nogle af de bivirkninger, der er nævnt i afsnit 4, kan påvirke din evne til at køre bil eller anvende maskiner.
Driving and using machines Some effects mentioned under section 4. “ Possible side effects” may affect the ability to drive or use machines.
27 Vigtig information om nogle af de øvrige indholdsstoffer i Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram Der findes thiomersal (konserveringsmiddel) i dette produkt, og det er muligt, at du kan få en overfølsomhedsreaktion.
Important information about some of the ingredients of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Dette produkt indeholder mindre end 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) pr. dosis, dvs. det er i alt væsentlighed natrium - og kaliumfrit.
27 This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i. e. essentially sodium- and potassium-free.
SÅDAN ANVENDES PREPANDEMISK INFLUENZAVACCINE (H5N1) (SPLIT VIRION, INAKTIVERET, ADJUVERET) GLAXOSMITHKLINE BIOLOGICALS 3, 75 MIKROGRAM
HOW PREPANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED) GLAXOSMITHKLINE BIOLOGICALS 3.75 µg IS GIVEN
Du vil få to vaccinationer af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram.
You will receive two doses of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg.
Det anbefales at den anden vaccination bliver givet mindst 3 uger efter den første vaccination.
The second dose should be given after an interval of at least three weeks.
Lægen vil give dig Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram som en indsprøjtning i overarmsmusklen.
The doctor or nurse will give Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg as an injection into your upper arm muscle.
Spørg lægen eller apoteket, hvis der er noget, du er i tvivl om, eller føler dig usikker på.
If you have any further questions on the use of this product, ask your doctor or nurse.
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg can cause side effects, although not everybody gets them.
♦ Meget almindelige (det sker efter mere end 1 ud af 10 vaccinedoser): • træthed • hovedpine • smerter, rødmen, hævelse eller en hårdhed, hvor indsprøjtningen blev givet • feber • ømme muskler, ledsmerter
♦ Very common (these may occur with 1 in 10 doses or more of the vaccine): • Tiredness • Headache • Pain, redness, swelling or a hard lump at the injection site • Fever • Aching muscles, joint pain
♦ Almindelige (det sker efter mellem 1 og 10 ud af 100 vaccinedoser): • varme, kløe eller blåt mærke ved det sted hvor indsprøjtningen blev givet • øget svedtendens, kuldegysninger, influenzalignende symptomer • hævede kirtler i nakke, armhule eller lyske
♦ Common (these may occur with up to 1 in 10 doses of the vaccine): • Warmth, itching or bruising at the injection site • Increased sweating, shivering, flu-like symptoms • Swollen glands in the neck, armpit or groin
♦ Ikke almindelige (det sker efter mellem 1 og 10 ud af 1. 000 vaccinedoser): • prikken eller følelsesløshed i hænder eller fødder • svimmelhed • søvnighed • søvnløshed • diaré, opkastning, mavesmerter, utilpashed • kløen, udslæt • generel utilpashed
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Tingling or numbness of the hands or feet • Dizziness • Sleepiness • Sleeplessness • Diarrhoea, vomiting, stomach pain, feeling sick • Itching, rash • Generally feeling unwell
Yderligere bivirkninger, som er set i dagene eller ugerne efter vaccination med en almindelig influenzavaccine omfatter:
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
28 ♦ Ikke almindelige (det sker efter mellem 1 og 10 ud af 1. 000 vaccinedoser): • Reaktioner i huden, fx nældefeber
♦ Rare (these may occur with up to 1 in 1,000 doses of the vaccine): • Severe stabbing or throbbing pain along one or more nerves
♦ Sjældne (det sker efter mellem 1 og 10 ud af 10. 000 vaccinedoser): • stærke stikkende eller dunkende smerter langs en eller flere nerver • krampeanfald • lavt indhold af blodplader i blodet, som kan medføre blødninger eller blå mærker • overfølsomhedsreaktioner, der kan føre til alvorligt blodtryksfald, og som, hvis de ikke behandles, kan føre til kollaps, bevidstløshed og dødsfald
28 • Fits • Low blood platelet count which can result in bleeding or bruising • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death