natgillin/translations-raw huggingface dataset:
Vaccinen må ikke gives til personer, der har haft en anafylaktisk reaktion (svær overfølsomhedsreaktion) over for en af vaccinens komponenter eller over for et af de sporstoffer, den indeholder (meget lavt), f. eks. æg, kyllingeprotein, ovalbumin (et protein i æggehvide), formaldehyd, gentamicinsulfat (et antibiotikum) og natriumdeoxycholat.
The vaccine should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
CHMP besluttede, at fordelene ved ‘ præpandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals ’ er større en risiciene til aktiv immunisering mod H5N1 - undertypen af influenza A- virus.
The CHMP decided that the benefits of ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ are greater than its risks for active immunisation against H5N1 subtype of influenza A virus.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ‘ præpandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals ’ til GlaxoSmithKline Biologicals S. A. den 26 september 2008.
The European Commission granted a marketing authorisation valid throughout the EU for ‘ Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals ’ to GlaxoSmithKline Biologicals S. A. on 26 September 2008.
Styrk e
Strength
Prepandemisk influenza vaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals
Prepandemic influenza
Suspension og emulsion til injektionsvæske, emulsion.
Suspension and Emulsion for
suspension (H5N1): hætteglas (glas) emulsion (adjuvans): hætteglas (glas)
suspension (H5N1): vial (glass)
2, 5 ml (suspension) 2, 5 ml (emulsion)
2.5 ml (suspension)
50 hætteglas (suspension) 2 x 25 hætteglas (emulsion)
2 x 25 vials (emulsion)
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram suspension og emulsion til injektionsvæske, emulsion.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension and emulsion for emulsion for injection.
Efter rekonstitution indeholder 1 dosis (0, 5 ml):
After mixing, 1 dose (0.5 ml) contains:
Split influenzavirus, inaktiveret, indeholdende antigen * svarende til:
Split influenza virus inactivated, containing antigen* equivalent to:
A/ VietNam/ 1194/ 2004 (H5N1) - lignende stamme (NIBRG- 14) * opformeret i æg ** hæmagglutinin
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * propagated in eggs ** haemagglutinin
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)
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
6. 5, for antallet af doser pr. hætteglas.
See section 6.5 for the number of doses per vial.
Hjælpestoffer: indeholder 5 mikrogram thiomersal
It contains 5 micrograms thiomersal
Aktiv immunisering mod H5N1 undertyper af influenza- A- virus.
Active immunisation against H5N1 subtype of Influenza A virus.
5. 1).
This indication is based on immunogenicity data from healthy subjects aged 18-60 years following administration of two doses of vaccine prepared from A/ VietNam/ 1194/ 2004 NIBRG-14 (H5N1) (see section 5.1).
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram bør anvendes i overensstemmelse med officielle retningslinjer.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.
Til voksne i alderen fra 18 til 60 år:
Adults from the age of 18 to 60 years:
1 dosis på 0, 5 ml givet på en udvalgt dag.
1 dose of 0.5 ml at an elected date.
For at opnå maksimal effekt bør der gives yderligere en vaccinedosis mindst 3 uger senere.
A second dose of vaccine should be given after an interval of at least three weeks.
Der er ingen erfaring med vaccination af børn og voksne over 60 år.
There is no experience in children and adults above 60 years of age.
5. 1.
2 For further information, see section 5.1.
Tidligere anafylaktisk (dvs. livstruende) reaktion over for et eller flere af stofferne eller over for spor af reststoffer (æg og kyllingeprotein, ovalbumin, formaldehyd, gentamicinsulphat 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.
4. 4, 4. 8 og 6. 1
See sections 4.4, 4.8 and 6.1.
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, over for thiomersal og reststoffer (æg og kyllingeprotein, ovalbumin, gentamicinsulphat og natriumdeoxycholat).
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 residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram må under ingen omstændigheder gives intravaskulært eller intradermalt.
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should under no circumstances be administered intravascularly or intradermally.
5. 1).
A protective immune response may not be elicited in all vaccinees (see section 5.1).
Efter en influenzavaccination kan der ses falsk positive resultater m. h. t antistoffer mod HIV- 1, hepatitis C og specielt HTLV- 1 i serum undersøgt med ELISA- metoden.
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1.
I disse tilfælde vil den efterfølgende Western Blot- analyse give negative resultater.
In such cases, the Western blot method is negative.
Der foreligger ingen data om Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram (eller andre vacciner, der indeholder AS03 - adjuvans) til gravide kvinder.
No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
3 Der foreligger ingen data om Prepandemisk influenzavaccine GlaxoSmithKline til ammende kvinder.
3 There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
4. 8, kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
Some of the effects mentioned under section 4.8 “ Undesirable Effects” may affect the ability to drive or operate machinery.
5. 000 personer på 18 år eller derover, som fik vaccine indeholdende med mindst 3, 75 mikrogram HA/ AS03.
The incidence of adverse reactions has been evaluated in approximately 5,000 subjects 18 years old and above who received formulations containing at least 3.75 microgram HA/ AS03.
De indberettede bivirkninger er opstillet ud fra følgende hyppighed:
Adverse reactions reported are listed according to the following frequency:
Meget almindelig (≥ 1/ 10) Almindelig (≥ 1/ 100 til < 1/ 10) Ikke almindelig (≥ 1/ 1. 000 til < 1 / 100) Sjælden ((≥1/ 10. 000 til < 1/ 1. 000) Meget sjælden (< 1/ 10. 000)
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100) Rare (≥ 1/ 10,000 to < 1/ 1,000) Very rare (< 1/ 10,000)
Bivirkningerne er inden for hver hyppighedsgruppe opstillet efter alvorlighed med den mest alvorlige nævnt først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Nervesystemet Meget almindelig: hovedpine Ikke almindelig: paræstesi, somnolens, svimmelhed
Nervous system disorders Very common: headache Uncommon: paraesthesia, somnolence, dizziness
Mave- tarmkanalen Ikke almindelig: gastro- intestinale symptomer (fx diaré, opkastning, mavesmerter, kvalme)
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Hud og subkutane væv 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
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: induration, hævelser, smerter og rødmen ved administrationsstedet, feber, træthed Almindelig: kuldegysninger, influenzalignende symptomer, reaktioner på administrationsstedet (fx varme, kløe) Ikke almindelig: utilpashed
General disorders and administration site conditions Very common: induration, swelling, pain and redness at the injection site, fever, fatigue, Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus) Uncommon: malaise
Psykiske forstyrrelser Ikke almindelig: søvnløshed
Psychiatric disorders Uncommon: insomnia
Der findes ingen data fra overvågning efter markedsføring for Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram.
4 No post-marketing surveillance data are available following Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg administration.
4 I forbindelse med overvågning efter markedsføring af interpandemiske, trivalente vacciner er der indberettet følgende bivirkninger:
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have been reported:
Neurologiske forstyrrelser, fx encefalomyelitis, neuritis og Guillain- Barré- syndrom.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Influenzavacciner, ATC- kode J07BB02.
Influenza vaccines, ATC Code J07BB02
Immunrespons mod virusstammen i Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram:
Immune response against vaccine strain contained in Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
I et konsistensstudie fik mere end 900 personer i alderen 18- 60 år Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram efter vaccinationsprogrammet på dag 0 og 21.
In a consistency study, more than 900 subjects aged 18-60 years received Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg following a 0, 21 days schedule.
21 dage efter den første og anden vaccinedosis var seroprotektionsraterne, serokonverteringsraterne og serokonverteringsfaktorerne for antihæmagglutinin (anti- HA) - antistof følgende:
Twenty-one days after the first and second dose of the vaccine, the seroprotection rate, the seroconversion rate and seroconversion factor for anti-haemagglutinin (anti-HA) antibody were as follows:
anti- HA- antistof Seroprotektionsrate * † Serokonverteringsrate † Serokonverteringsfaktor † * anti- HA ≥ 1: 40
anti-HA antibody Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
21 dage
21 days after 1st dose 44.5% 42.5% 4.1
21 dage efter anden dosis 94, 3% 93, 7% 39, 8
21 days after 2nd dose 94.3% 93.7% 39.8
† seroprotektionsrate: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1: 40; serokonverteringsrate: andelen af forsøgspersoner, som enten var seronegative før vaccination og opnår en beskyttende post- vaccinationstiter på ≥ 1: 40, eller som var seropositive før vaccination og opnår en firdobbelt titer- stigning; serokonverteringsfaktor: forholdet mellem post - vaccinationsgeometrisk middeltiter (GMT) og prævaccinations- GMT.
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
21 dage efter administration af den anden vaccinedosis havde 96, 0% af personerne en firdobbelt stigning i serum- neutraliserende antistoftiter.
Twenty-one days after administration of the second dose, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres.
En neutraliserende antistoftiter på mindst 1: 80 blev opnået hos 97, 8% af personerne på dag 42.
A neutralising antibody titre of at least 1:80 was achieved in 97.8% of subjects at day 42.
I et klinisk forsøg til bestemmelse af dosis fik 50 personer i alderen 18- 60 år en dosis på 3, 75 mikrogram HA/ AS03 i 1 ml på dag 0 og 21.
5 In a dose finding study in subjects aged 18-60 years, 50 subjects received a dose of 3.75 micrograms HA/ AS03 in a volume of 1 ml at 0 and 21 days.
5 serokonverteringsfaktorerne for antihæmagglutinin( anti- HA) - antistof var på dag 42 (efter 2 doser) og på dag 180 (vedvarende) følgende:
The seroprotection rates, seroconversion rates and seroconversion factors for anti-haemagglutinin (anti-HA) antibody at day 42 (post dose 2) and day 180 (persistence) were as follows:
anti- HA- antistof Seroprotektionsrate * † Serokonverteringsrate † Serokonverteringsfactor † * anti- HA ≥ 1: 40
anti-HA antibody Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
dag 42 84% 82% 27, 9
Day 42 84% 82% 27.9
dag 180 54% 52% 4, 4
Day 180 54% 52% 4.4
En firdobbelt stigning i serum- neutraliserende antistoftiter blev set hos 85, 7% af personerne på dag 42 og hos 72% på dag 180.
A 4-fold increase in serum neutralising antibody titres was observed in 85.7% of subjects at day 42 and 72% at day 180.
Krydsreaktionsimmunrespons mod varianter af A/ Vietnam/ 1194/ 2004 (H5N1):
Cross-reactive immune response against variants of A/ Vietnam/ 1194/ 2004 (H5N1):
I konsistensstudiet var seroprotektionsraten, serokonverteringsraten og serokonverteringsfaktor for antistof antihæmagglutinin (anti- HA) - antistof mod A/ Indonesia/ 5/ 2005 på dag 21 efter den anden dosis følgende:
In the consistency study the seroprotection rate, seroconversion rate and seroconversion factor for anti- haemagglutinin (anti-HA) antibody against A/ Indonesia/ 5/ 2005 at 21 days after the second dose were as follows:
Seroprotektionsrate * † Serokonverteringsrate † Serokonverteringsfactor † * anti- HA ≥ 1: 40
Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
† seroprotektionsrate: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1: 40; serokonverteringsrate: andelen af forsøgspersoner, som enten var seronegative før vaccination og opnår en beskyttende post- vaccinationstiter på ≥ 1: 40, eller som var seropositive før vaccination og opnår en firdobbelt titer- stigning; serokonverteringsfaktor: forholdet mellem post - vaccinationsgeometrisk middeltiter (GMT) og prævaccinations- GMT.
seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
En firdobbelt stigning i serum- neutraliserende antistoftiter blev set hos 91, 4% af personerne på dag 42.
A 4-fold increase in serum neutralising antibody titres was obtained in 91.4% of subjects at day 42.
I et klinisk forsøg til bestemmelse af dosis var seroprotektionsraterne, serokonverteringsraterne og serokonverteringsfaktorerne for antistof antihæmagglutinin (anti- HA) - antistof mod H5N1- antigen drift- varianter 21 dage efter anden dosis følgende:
In the dose finding studythe seroprotection rate, seroconversion rate and seroconversion factor against H5N1 drift variants 21 days after the second dose were as follows:
Seroprotektionsrate * † Serokonverteringsrate † Serokonverteringsfaktor † * anti- HA ≥ 1: 40
Seroprotection rate*† Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
† seroprotektionsrate: andelen af forsøgspersoner med HI- titer ≥ 1: 40; serokonverteringsrate: andelen af forsøgspersoner, som enten var seronegative før vaccination og opnår en beskyttende post - vaccinationstiter på ≥ 1: 40, eller som var seropositive før vaccination og opnår en firdobbelt titer - stigning; serokonverteringsfaktor: forholdet mellem post- vaccinations- GMT og prævaccinations - GMT.
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
6 21 dage efter anden vaccinedosis sås en firdobbelt stigning i serum- neutraliserende antistoftiter hos 77, 1% af personerne mod A/ Indonesia/ 5/ 2005- stammen, hos 75, 0% af personerne mod A/ Anhui/ 01/ 2005 og hos 85, 0% af personerne mod A/ Turkey/ Turkey/ 1/ 2005.
6 Twenty one days after the second dose, a 4-fold increase in serum neutralising antibody titres was obtained in 77.1% of subjects against the A/ Indonesia/ 5/ 2005 strain, in 75.0% of subjects against A/ Anhui/ 01/ 2005 and in 85.0% of subjects against A/ Turkey/ Turkey/ 1/ 2005.
Vaccinens evne til at yde beskyttelse mod homologe og heterologe virusstammer er vurderet præ - klinisk ud fra et belastningsforsøg med fritter.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models.
I hvert forsøg blev fire grupper med hver 6 fritter vaccineret intramuskulært med en AS03- adjuvans - vaccine indeholdende HA fra H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG- 14).
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/ A/ Vietnam/ 1194/ 04 (NIBRG-14).
Doser på 15, 5, 1, 7 eller 0, 6 mikrogram HA blev testet i det homologe ekspositionsforsøg og doser på 15, 7, 5, 3, 8 eller 1, 75 mikrogram HA blev testet i det heterologe belastningsforsøg.
Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Fritterne blev vaccineret på dag 0 og 21 og eksponeret intra- trachealt på dag 49 med en letal dosis af H5N1/ A/ Vietnam/ 1194/ 04 eller heterolog H5N1/ A/ Indonesia/ 5/ 05.
Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/ A/ Vietnam/ 1194/ 04 or heterologous H5N1/ A/ Indonesia/ 5/ 05.
Af de dyr, som havde fået adjuvans- vaccine var 87% og 96% beskyttet mod henholdsvis den letale homologe eller den heterologe eksposition.
Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively.
Både i kontrolgruppen som fik non- adjuveret vaccine og kontrolgruppen, som blev vaccineret alene med adjuvans døde alle dyr eller måtte aflives, fordi de var døende 3- 4 dage efter påbegyndt belastning.
In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
Prækliniske data viser ikke nogen risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter akutte og gentagne doser, lokal tolerance, fertilitet hos kvinder, toksicitet for foster/ nyfødt barn (til og med afslutningen af ammeperioden).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Polysorbat 80 Octoxinol 10 Thiomersal Natriumchlorid (NaCl) Dinatriumhydrogenphosphat (Na2HPO4) Kaliumdihydrogenphosphat (KH2PO4) Kaliumchlorid (KCl) Magnesiumchlorid (MgCl2) Vand til injektionsvæsker
Polysorbate 80 Octoxynol 10 Thiomersal Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Magnesium chloride (MgCl2) Water for injections
2.
For adjuvants, see section 2.
- en pakke med 50 hætteglas (type I- glas) hver indeholdende 2, 5 ml suspension (10 x 0, 25 ml
- one pack of 50 vials (type I glass) of 2.5 ml suspension (10 x 0.25 ml doses) with a stopper
dosis) og forsynet med prop (butylgummi).
(butyl rubber).
- to pakker med 25 hætteglas (type I- glas) hver indeholdende 2, 5 ml emulsion (10 x 0, 25 ml
- two packs of 25 vials (type I glass) of 2.5 ml emulsion (10 x 0.25 ml doses) with a stopper
dosis) og forsynet med prop (butylgummi)
(butyl rubber).
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).
6. 6 Regler for destruktion < og anden håndtering >
6.6 Special precautions for disposal and other handling
Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram består af to hætteglas:
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Hætteglas A: multidosis- hætteglas med antigen (suspension) Hætteglas B: multidosis- hætteglas med adjuvans (emulsion).
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Før emulsionen og suspensionen sammenblandes, bør de to komponenter have stuetemperatur, omrystes og inspiceres visuelt for fremmede partikler og/ eller ændringer i det fysiske udseende.
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Efter rekonstitution svarer indeholdet af Prepandemisk influenzavaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals 3, 75 mikrogram (5 ml) til 10 vaccinedoser.
The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Hver enkel vaccinedosis (0, 5 ml) udtrækkes vha. en injektionssprøjte.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
KG Zirkustraße 40, D- 01069 Dresden Tyskland
KG Zirkustraße 40, D-01069 Dresden Germany
89, rue de l' Institut BE- 1330 Rixensart Belgien
89, rue de l'Institut B-1330 Rixensart Belgium