natgillin/translations-raw huggingface dataset:
Liste over bivirkninger De sete bivirkninger er opstillet ud fra følgende hyppighed:
List of adverse reactions Adverse reactions reported are listed according to the following frequency:
For at opnå maksimal effekt skal anden vaccinedosis på 0,5 ml gives i intervallet mindst 3 uger og indtil 12 måneder efter den initiale dosis.
A second dose of 0.5 ml should be given after an interval of at least three weeks and up to twelve months after the first dose for maximum efficacy.
Brug af anden medicin sammen med Prepandrix Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig eller hvis du for nylig er blevet vaccineret med en anden vaccine.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
Prepandrix består af to hætteglas:
Prepandrix consists of two containers:
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Antigen, suspension til Prepandrix
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Prepandrix
1 geometrisk middeltiter 2 andel af personer med en titer ≥ 1:28
2 % of subjects with titres ≥1:28
Anti-HA-antistof
anti-HA antibody
Ved overvågning efter markedsføring af AS03-adjuveret vaccine indeholdende 3,75 µg HA fra A/California/7/2009 (H1N1) blev følgende bivirkninger rapporteret:
From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported:
Der er meget begrænsede sikkerheds- og immunogenicitetsdata tilgængelige for administration af en AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) og for administration af halv vaccinedosis (dvs. 1,875 μg HA og halv mængde AS03-adjuvans) på dag 0 og dag 21 til børn i alderen 3-9 år.
There are very limited safety and immunogenicity data available on the administration of an AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) and on administration of half a dose of the vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years.
Meget begrænsede data for seronegative personer > 80 år (n = 5) viste, at ingen personer opnåede serobeskyttelse efter administration af to enkeltdoser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1).
Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1).
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Et forlænget doseringsinterval blev undersøgt i studie D-H5N1-012, i hvilket en gruppe personer i alderen 18-60 år modtog to doser af Prepandrix, som indeholdt A/Vietnam/1194/2004 virusstammen, med 6 måneders eller 12 måneders interval.
An extended dosing interval was investigated in study D-H5N1-012 in which a group of subjects 1860 years of age received two doses of Prepandrix containing the A/Vietnam/1194/2004 strain 6 months or 12 months apart.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN GlaxoSmithKline Biologicals s.a.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Polysorbat 80, octoxinol 10, thiomersal, natriumchlorid, dinatriumhydrogenphosphat, kaliumdihydrogenphosphat, kaliumchlorid, magnesiumchlorid, vand til injektionsvæsker
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Split influenzavirus, inaktiveret, indeholdende antigen* svarende til 3,75 mikrogram hæmagglutinin/dosis *Antigen: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2)
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
2 firdobbelt stigning i serumneutraliserende antistoftiter 3 andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80
LÆGEMIDLETS NAVN Emulsion til Prepandrix injektionsvæske, emulsion
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Prepandrix
Seroprotektionsrate1
Seroprotection rate
En pakke indeholder: - en pakke med 50 hætteglas (type I-glas) hver indeholdende 2,5 ml suspension og forsynet med prop (butylgummi).
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Seroprotektionsraten mod A/Indonesia var 92 % 21 dage efter boostervaccination og 69,2 % på dag
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180.
21 dage efter anden dosis n = 48
21 days after 2nd dose N=48
Det anbefales at bruge en 23-G kanyle på sprøjten.
It is recommended to equip the syringe with a 23-G needle.
Børn i alderen 3-9 år har i et klinisk studie fået enten to voksendoser (0,5 ml) eller to halve voksendoser (0,25 ml) af en tilsvarende vaccine indeholdende A/Vietnam/1194/2004.
In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult (0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004.
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Prepandrix Sådan får du Prepandrix Bivirkninger
What Prepandrix is and what it is used for What you need to know before you receive Prepandrix How Prepandrix is given
Efter sammenblandingen, skal den færdige vaccine indspøjtes inden for 24 timer og må ikke opbevares over 25 °C.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C.
dosis (n = 131)
Double dose (N=131)
Anti-HA og neutraliserende antistofrespons mod A/Indonesia/05/2005 fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra den samme stamme er vist at være sammenlignelig med immunresponset mod A/Vietnam/1194/2004 fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra denne samme stamme.
The anti-HA and neutralising antibody responses to A/Indonesia/05/2005 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain have been shown to be comparable with the immune responses to A/Vietnam/1194/2004 elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from this same strain.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Adjuvans, emulsion til Prepandrix i.m.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Prepandrix
21 dage efter første dosis n = 55
21 days after 1st dose N=55
Uanset om der var blevet givet en eller to primære vaccinedoser 6 måneder tidligere, var seroprotektionsraterne > 80 % mod A/Indonesia efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 og seroprotektionsraterne > 90 % mod A/Vietnam efter en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005.
Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
En sådan blodprøve kan vise et forkert resultat i de første få uger efter vaccination med Prepandrix.
In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct.
Immunrespons mod A/Vietnam/1194/2004 3-5 år 21 dage efter anden dosis 6 måneder efter vaccination
Immune response to A/Vietnam/1194/2004 3-5 years 21 days after 2nd dose 6 months after vaccination
DATO FOR FØRSTE MAKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2008
Sådan får du Prepandrix
How to store Prepandrix
Fortæl lægen, hvis du ved, at du er overfølsom over for andre ting.
Tell your doctor if you have any known allergies.
Bivirkninger er blevet vurderet i kliniske studier med ca. 5.000 personer på 18 år og derover, som fik Prepandrix indeholdende mindst 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1)-stammen.
Clinical studies have evaluated the incidence of adverse reactions in approximately 5,000 subjects 18 years old and above who received Prepandrix containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 µg HA.
Hverken hos børn, som fik halv voksendosis, eller hos børn, der fik fuld voksendosis, blev der set nogen stigning i forekomsten af bivirkninger efter anden dosis, bortset fra nogle bivirkninger, hvor forekomsten var højere efter anden dosis, især hyppigheden af feber hos børn < 6 år.
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
Der skal udvises forsigtighed, når vaccinen gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1, over for thiomersal og reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat).
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Administration af en AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1)
Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1)
dosis (n = 81)
Double dose (N=81)
2,5 ml Efter sammenblanding med adjuvans, emulsion: 10 doser a 0,5 ml
2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml)
Data fra AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 er derfor relevant for anvendelsen af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005.
Therefore, the data that have been generated with AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 are considered to be relevant to the use of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
I kliniske immunogenicitetsstudier med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) hos personer i alderen 18-60 år er følgende anti-hæmagglutinin (antiHA)-antistofrespons set:
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) in subjects 18-60 years old, the anti-haemagglutinin (anti-HA) antibody responses were as follows:
Efter administration af to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21 til 140 personer i alderen 18-60 år var anti-HA-antistof-responset mod A/Vietnam/1194/2004 følgende:
After two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses to A/Vietnam/1194/2004 were as follows:
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer):
Very common: may affect more than 1 in 10 people
I et klinisk studie (D-H5N1-009) blev reaktogeniciteten evalueret hos børn i alderen 3-5 år og 6-9 år, som havde fået enten to voksendoser (0,5 ml) eller to halve voksendoser (0,25 ml) (med 21 dages interval) af pandemisk beredskabsvaccine (H5N1 A/Vietnam/1194/2004 fremstillet i Dresden, Tyskland).
A clinical study (D-H5N1-009) evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of pandemic preparedness vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
• hvis du tidligere har haft en pludselig, livstruende, overfølsomhedsreaktion mod et af indholdsstofferne i denne vaccine (angivet i punkt 6) eller over for andre stoffer, som kan være til stede i meget små mængder f.eks. æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat.
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
Efter sammenblanding af suspension og emulsion fra hætteglassene fremkommer en vaccine i en flerdosisbeholder.
The suspension and emulsion vials once mixed form a multidose container.
andel af personer, som opnåede en serumneutraliserende antistoftiter på mindst 1:80
% of subjects reaching a serum neutralising antibody titre of at least 1:80
Immunrespons mod A/Indonesia/05/2005 (H5N1) I et klinisk studie (Q-Pan-H5N1-001), hvor 140 personer i alderen 18-60 år fik to doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21, var anti-HAantistofresponset følgende: anti-HA-antistof
Immune response against A/Indonesia/05/2005 (H5N1) In a clinical study (Q-Pan-H5N1-001) in which two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 were administered on days 0 and 21 to 140 subjects aged 18-60 years, the anti-HA antibody responses were as follows: anti-HA antibody
Irritabilitet Appetitløshed Kulderystelser - = ikke tilgængelig
Shivering NA=not available
En dosis AS03-adjuveret vaccine indholdende 3,75 μg HA fra A/Indonesia/05/2005 administreret efter en eller to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004.
A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2) i.m.
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) I.M.
Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat og natriumdeoxycholat) i denne vaccine.
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.
GMT1 Seropositivitetsrate2
Seropositivity rate2
- to pakker med 25 hætteglas (type I-glas) hver indeholdende 2,5 ml emulsion og forsynet med prop (butylgummi)
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Hos børn i aldersgrupperne 3-5 år og 6-9 år, som fik enten to fulde doser eller to halve doser AS03adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1), var anti-HAantistofresponset mod A/Indonesia/5/2005 på dag 42 følgende:
In the subjects aged 3 to 5 and 6 to 9 years old who received two doses of either a full or a half dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1), the anti-HA antibody responses against A/Indonesia/5/2005 at day 42 were as follows:
Krydsreaktionsimmunrespons fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 (H5N1)
Cross-reactive immune response elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1)
I et andet studie fik 49 personer i alderen 18-60 år to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 på dag 0 og 21.
In a second study, 49 subjects aged 18-60 years received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 on days 0 and 21.
Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer):
Very rare: may affect up to 1 in 10,000 people
A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2) 3,75 mikrogram** pr. 0,5 ml
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml
Personerne i studie D-Pan-H5N1-009 blev fulgt og undersøgt for et vedvarende immunrespons.
Subjects of D-Pan-H5N1-009 were followed up for persistence of the immune response.
Prepandrix suspension og emulsion til injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
Prepandrix suspension and emulsion for emulsion for injection Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
• hvis du har haft andre overfølsomhedsreaktioner end den pludselige, livstruende overfølsomhedsreaktion, over for et af indholdsstofferne i denne vaccine (angivet i punkt 6) eller over for thiomersal, æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulfat (antibiotikum) eller natriumdeoxycholat.
• if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
Seroprotektionsraten 6, 12, 24 og 36 måneder efter første dosis var følgende:
The seroprotection rates 6, 12, 24 and 36 months after the first dose were as follows: anti-HA antibody
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer):
Rare: may affect up to 1 in 1,000 people
Almindelig: blodudtrædninger i huden ved administrationsstedet, øget svedtendens Ikke almindelig: hudkløe, udslæt
Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash
måned n = 48
Month 6 N=48
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
Common: may affect up to 1 in 10 people
KG Zirkusstraße 40, D-01069 Dresden Tyskland
GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkusstraße 40, D-01069 Dresden Germany
Seroprotektionsrate1 1seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40
Seroprotection rate1 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved administrationsstedet, rødme og feber) efter anden dosis til børn under 6 år blev observeret i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik Prepandrix.
In other clinical studies where children 6 months to 17 years received Prepandrix, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
måned n = 40
Month 6 N=40
Suspension til Prepandrix injektionsvæske, emulsion Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret)
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Prepandrix Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Krydsreaktionsimmunrespons fremkaldt af AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1)
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1):
Amning
Induration
Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30
Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
1seroprotektionsrate: andelen af personer med hæmagglutinationshæmnings (HI) titer ≥ 1:40
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40
I et klinisk studie (D-Pan-H5N1-012) fik personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra enten A/Vietnam/1194/2004 eller Indonesia/05/2005 6 måneder efter administration af en eller to primære doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på henholdsvis dag 0 eller dag 0 og 21.
In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21.
I et andet klinisk studie (D-Pan-H5N1-015) fik 39 personer i alderen 18-60 år en dosis AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Indonesia/05/2005 fjorten måneder efter at have modtaget to doser AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 på dag 0 og 21.
In another clinical study (D-Pan-H5N1-015), 39 subjects aged 18-60 years received a dose of AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om, før du får denne vaccine.
If you are not sure, talk to your doctor or nurse before having this vaccine.
Prepandrix suspension og emulsion til injektionsvæske, emulsion.
NAME OF THE MEDICINAL PRODUCT Prepandrix suspension and emulsion for emulsion for injection.
• Kløen, udslæt
• Itching, rash
(n = 86)
Single dose (N=86)
Tilsvarende bivirkninger og hyppigheder, som anført nedenfor, er set i kliniske studier med personer (n = 201), som fik Prepandrix indeholdende 3,75 μg HA/AS03 fra A/Indonesia/05/2005 H5N1stammen.
In clinical trials in which subjects (N=201) received Prepandrix containing 3.75 microgram HA/AS03 of A/Indonesia/05/2005 (H5N1) strain, the types and frequencies of adverse reactions were comparable with those reported below.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Suspension og emulsion til injektionsvæske, emulsion.
PHARMACEUTICAL FORM AND CONTENTS Suspension and emulsion for emulsion for injection 50 vials: suspension (antigen)
Induration Smerter
• Feeling tired
I et klinisk studie (D-Pan-H5N1-009) med AS03-adjuveret vaccine indeholdende 3,75 μg HA fra A/Vietnam/1194/2004 (H5N1) fik børn i alderen 3-5 år og 6-9 år administreret fuld dosis (0,5 ml) på dag 0 og dag 21 eller administreret halv dosis (0,25 ml) på dag 0 og dag 21.
In a clinical study (D-Pan-H5N1-009), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Lægemidlet er receptpligtigt.
- This vaccine has been prescribed for you only.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Adjuvans, emulsion til injektionsvæske.
PHARMACEUTICAL FORM AND CONTENTS Adjuvant emulsion for injection 25 vials: emulsion
24 måneder efter første dosis n = 411
24 months after the 1st dose
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer):
Uncommon: may affect upt o 1 in 100 people
- Lægen har ordineret Prepandrix til dig personligt.
Tell the doctor requesting these tests that you have recently received Prepandrix.
Det bør gives samme tid hver dag.
It should be given at the same time each day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ganfort den 19. maj 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Ganfort on 19 May 2006.
Værdierne blev reduceret med cirka 8-10 mmHg.
The values were lowered by about 8-10 mmHg.