natgillin/translations-raw huggingface dataset:
Gardasils immunogenicitet vurderedes i 8. 915 (Gardasil n = 4. 666; placebo n = 4. 249) kvinder i alderen 18 til 26 år og 3. 400 kvindelige (Gardasil n = 1. 471; placebo n = 583) og mandlige (Gardasil n = 1, 071; placebo n = 275) unge i alderen 9 til 17 år.
The immunogenicity of Gardasil was assessed in 8,915 (Gardasil n = 4,666; placebo n = 4,249) women 18 to 26 years of age and 3,400 female (Gardasil n = 1,471; placebo n = 583) and male (Gardasil n = 1,071; placebo n = 275) adolescents 9 to 17 years of age.
Typespecifikke immunanalyser, kompetitiv Luminex- baseret immunanalyse (cLIA) med typespecifikke standarder, blev brugt til at vurdere immunogenicitet for hver af vaccinetyperne.
Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
Denne analyse måler antistoffer imod et enkelt neutraliserende epitop for hver enkelt af HPV- typerne.
This assay measures antibodies against a single neutralizing epitope for each individual HPV type.
Immunrespons over for Gardasil
Immune Responses to Gardasil
I de kliniske undersøgelser blev i alt 99, 9%, 99, 8%, 99, 8% og 99, 6% af de personer, der modtog Gardasil, henholdsvis anti- HPV 6, anti- HPV 11, anti- HPV 16 og anti- HPV- 18 seropositive én måned efter 3. dosis i alle testede aldersgrupper.
In the clinical studies, 99.9%, 99.8%, 99.8%, and 99.6% of individuals who received Gardasil became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive respectively, by 1 month Postdose 3 across all age groups tested.
Gardasil fremkaldte høje anti- HPV geometriske middeltitre (GMT’ er) én måned efter 3. dosis i alle testede aldersgrupper.
Gardasil induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Anti- HPV- niveauerne i personer i placebogruppen, som havde overstået en HPV- infektion (seropositive og PCR- negative), var væsentligt lavere end dem, der induceredes af vaccinen.
Anti-HPV levels in placebo subjects who had cleared an HPV infection (seropositive and PCR negative) were substantially lower than those induced by the vaccine.
Hertil kommer, at anti- HPV- niveauerne (GMT’ er) hos vaccinerede personer forblev på eller over serostatus - skæringspunktet under langtidsopfølgningen i fase III undersøgelserne (se afsnittet om persistens).
Furthermore, anti-HPV levels (GMTs) in vaccinated subjects remained at or above serostatus cut-off during the long-term follow-up of the phase III studies (see below under Persistence).
Gardasils effekt hos yngre voksne overført til børn og unge
10 Bridging the Efficacy of Gardasil from Young Adult Women to Young Adolescents
Et klinisk studie (Protokol 016) sammenlignede Gardasils immunogenicitet i 10 - til 15- årige drenge og piger, med den der sås i 16 - til 23- årige yngre kvinder.
A clinical study (Protocol 016) compared the immunogenicity of Gardasil in 10- to 15-year-old boys and girls to those in 16- to 23-year old adolescent and young women.
I vaccinegruppen blev 99, 1 til 100% seropositive for alle vaccine- serotyper 1 måned efter 3. dosis.
In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
10 Tabel 4 sammenligner anti HPV 6, 11, 16 og 18 GMT’ er 1 måned efter 3. dosis hos 9 til 15- årige drenge og piger med de tilsvarende værdier for 16 til 26- årige yngre kvinder.
Table 4 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15-year-old boys and girls with those in 16- to 26-year old young women.
Immunogenicitetssammenligning mellem 9 - til 15- årige mandlige og kvindelige forsøgspersoner og 16 - til 26- årige voksne kvinder (per- protocol- population) baseret på titre målt med cLIA
Immunogenicity bridging between 9- to 15-year-old male and female subjects and 16- to 26-year-old adult women (per-protocol population) based on titres as measured by cLIA
(Protokol 016 og 018) (Protokol 016 og 018)
9- to 15-Year-Old Males (Protocols 016 and 018) n GMT (95% CI)
GMT (95% CI) n GMT (95% CI) n
9- to 15-Year-Old Females 16- to (Protocols 016 and 018) n GMT (95% CI)
GMT (95% CI)
26-Year-Old Females (Protocols 013 and 015) n GMT (95% CI)
6053 (5599, 6543) 1356 (1253, 1469)
883 1038 (975, 1106) 1387 (1299, 1481) 6053 (5599, 6543) 1356 (1253, 1469)
GMT - Geometrisk middeltiter i mMU/ ml (mMU= milli- Merck- enheder)
GMT- Geometric mean titre in mMU/ ml (mMU = milli-Merck units)
Anti- HPV- responser ved måned 7 blandt 9 til 15 år gamle piger og drenge var ikke mindre end anti - HPV- responser i 16 til 26 år gamle kvinder, for hvem effekten var blevet bestemt i fase III undersøgelserne.
Anti-HPV responses at Month 7 among 9- to 15-year-old girls and boys were non-inferior to anti-HPV responses in 16- to 26-year-old young women for whom efficacy was established in the phase III studies.
Immunogenicitet var relateret til alder, og anti- HPV- niveauer ved måned 7 var signifikant højere i unge personer under 12- års alderen end i dem, der var over denne alder.
Immunogenicity was related to age and Month 7 anti-HPV levels were significantly higher in younger individuals below 12 years of age than in those above that age.
På grundlag af denne immunogenicitetssammenligning antages der at være en sammenlignelig effekt af Gardasil i 9 - til 15- årige piger.
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old girls is inferred.
Immunogenicitet og sikkerhed af Gardasil er blevet påvist i 9 til 15 år gamle drenge.
Immunogenicity and safety of Gardasil have been demonstrated in 9- to 15-year-old boys.
Beskyttende effekt er ikke blevet undersøgt hos mænd.
Protective efficacy has not been evaluated in males.
I Protokol 007 sås der høje niveauer af anti- HPV 6, 11, 16, 18 GMT’ er ved måned 7.
In Protocol 007 peak anti-HPV 6, 11, 16, 18 GMTs were observed at Month 7.
GMT’ erne faldt frem til måned 24, hvorefter de stabiliseredes indtil måned 60.
The GMTs declined through Month 24 and then stabilized until at least Month 60.
Immunitetens præcise varighed efter en 3- dosis serie er ikke blevet fastlagt.
The exact duration of immunity following a 3-dose series has not been established.
Ved afslutning af en fase III undersøgelse var i alt 90%, 95%, 98% og 60% af de personer, der modtog Gardasil i en per- protokol immunogenicitet population, henholdvis anti- HPV 6, anti- HPV 11, anti- HPV 16 og anti- HPV 18 seropositive.
In phase III studies, at end of study 90%, 95%, 98% and 60% of subjects who received Gardasil in the per-protocol immunogenicity population were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti HPV 18 seropositive, respectively.
Personer som var seronegative for anti- HPV 6, 11, 16, 18 i cLIA ved forsøgets afslutning stadig var beskyttet imod klinisk sygdom.
Subjects who were seronegative for anti-HPV 6, 11, 16, 18 in the cLIA at end of study were still protected against clinical disease.
Der sås evidens for immunhukommelsesrespons hos vaccinerede personer, som var seropositive over for de( n) relevante HPV- type( r) forud for vaccination.
Evidence of an anamnestic response was seen in vaccinated individuals who were seropositive to relevant HPV type(s) prior to vaccination.
Responsen oversteg det anti- HPV GMT, der sås 1 måned efter dosis 3.
In addition, a subset of vaccinated individuals who received a challenge dose of Gardasil 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Evaluering af farmakokinetiske egenskaber er ikke påkrævet for vacciner.
Evaluation of pharmacokinetic studies is not required for vaccines.
De non- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af enkelt og gentagen dosistoksicitet og lokal tolerance.
11 Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Gardasil inducerede et specifikt antistofrespons mod HPV- type 6, 11, 16 og 18 i drægtige rotter efter en eller flere intramuskulære injektioner.
Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Der var ingen
Antibodies against all four HPV types were transferred to the offspring during gestation and possibly during lactation.
11 behandlingsrelaterede effekt på afkommets udvikling, opførsel, reproduktion eller fertilitet.
There were no treatment- related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Natriumklorid, L- histidin, polysorbat 80 natriumborat vand til injektioner
Sodium chloride L-histidine Polysorbate 80 Sodium borate Water for injections
2.
For adjuvant, see section 2.
0, 5 ml suspension i et hætteglas (type 1 glas) med prop (FluroTec- belagt eller Teflon- belagt klorbutylelastomer) og aftagelig plasthætte (aluminium krympebånd) i en pakkestørrelse på 1, 10 eller 20 stk.
0.5 ml suspension in a vial (Type 1 glass) with stopper (FluroTec-coated or Teflon-coated chlorobutyl elastomer) and flip-off plastic cap (aluminium crimp band) in a pack size of 1, 10 or 20.
Ikke alle pakningsstørrelser markedsføres.
Not all pack sizes are marketed.
Vaccinen skal anvendes som leveret; ingen fortynding eller rekonstitution er nødvendig.
The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Hele den anbefalede dosis af vaccinen bør anvendes.
The full recommended dose of the vaccine should be used.
For at opretholde vaccinen i suspension skal den omrystes omhyggeligt umiddelbart før indgivelsen
Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
Parenterale lægemidler bør inspiceres visuelt for partikler og misfarvning forud for indgivelse.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Bortskaf produktet, hvis der konstateres partikler, eller hvis det fremstår misfarvet.
Discard the product if particulates are present or if it appears discoloured.
Træk 0, 5 ml vaccinedosis ud af enkeltdosishætteglasset ved hjælp af en steril kanyle og sprøjte, der er fri for konserveringsmidler, antiseptiske midler og rensemidler.
Single-dose Vial Use 12 Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
Når der er gået hul på enkeltdosis - hætteglasset, skal den udtrukne vaccine bruges med det samme og hætteglasset bortskaffes.
Once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
12 Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overensstemmelse med lokale krav.
Any unused product or waste material should be disposed of in accordance with local requirements.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon, France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
20. september 2006
20th September 2006
Gardasil suspension til injektion i forfyldt sprøjte.
Gardasil, suspension for injection in a pre-filled syringe.
Suspension til injektion i forfyldt sprøjte.
Suspension for injection in a pre-filled syringe.
Pædiatrisk population:
14 Paediatric population:
14 Vaccinen skal gives som intramuskulær injektion.
The vaccine should be administered by intramuscular injection.
Beskyttelsens varighed er for tiden ikke kendt.
The duration of protection is currently unknown.
Der er blevet observeret beskyttende effekt i 4, 5 år efter gennemførelse af 3- dosisserien.
Sustained protective efficacy has been observed for 15 4.5 years after completion of the 3-dose series.
Opfølgningsundersøgelser over længere tid pågår (se pkt.
Longer term follow-up studies are ongoing (see section 5.1).
Der var ingen signifikant forskel i typen af medfødte misdannelser eller i hyppigheden af graviditeter med komplikationer hos kvinder, der fik Gardasil, og kvinder, der fik placebo..
There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Gardasil and placebo treated subjects.
16 I 5 kliniske forsøg (4 placebo- kontrollerede) blev Gardasil eller placebo givet til forsøgspersoner på inklusionsdagen og cirka 2 og 6 måneder senere.
16 In 5 clinical trials (4 placebo-controlled), subjects were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
Almindelig:
Very common: at the injection site: erythema, pain, swelling.
På injektionsstedet: blødning, kontusion, kløe.
Common: at the injection site: bruising, pruritus.
Hertil kommer, at der i kliniske undersøgelser er observeret bivirkninger med en hyppighed på under 1%, som af forskerne blev bedømt som værende vaccine - eller placeborelaterede,:
In addition, in clinical trials adverse reactions that were judged to be vaccine- or placebo-related by the study investigator were observed at frequencies lower than 1%:
Hud og subkutane væv Sjælden: urticaria
Rare: urticaria.
Der blev rapporteret syv tilfælde (0, 06%) af urticaria i Gardasil- gruppen, og 17 tilfælde (0, 18%) sås i gruppen der fik adjuvans- holdigt placebo.
Seven cases (0.06%) of urticaria were reported in the Gardasil group and 17 cases (0.18%) were seen in the adjuvant-containing placebo group.
Guillain- Barré syndrom, svimmelhed, hovedpine, synkope nogle gange ledsaget af tonisk- klonisk bevægelser.
Immune system disorders: hypersensitivity reactions including anaphylactic/ anaphylactoid reactions.
Mave- tarm- kanalen:
Nervous system disorders:
Kvalme, opkastning.
Guillain-Barré syndrome, dizziness, headache, syncope sometimes accompanied by tonic-clonic movements.
17 Knogler, led, muskler og bindevæv: artralgi, myalgi.
Gastrointestinal disorders: nausea, vomiting.
Overfølsomhedsreaktioner herunder anafylaktiske/ anafylaktoide reaktioner.
17 General disorders and administration site conditions: asthenia, fatigue, malaise.
4. 1 referere til high- grade cervikal intraepithelial neoplasi (CIN 2/ 3), high- grade vulva intraepithelial neoplasi (VIN 2/ 3) og high- grade vaginal intraepithelial neoplasi (VaIN 2/ 3).
The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/ 3), high-grade vulvar intraepithelial neoplasia (VIN 2/ 3) and high- grade vaginal intraepithelial neoplasia (VaIN 2/ 3).
Middelvarigheden for opfølgning i disse undersøgelser var 4, 0; 3, 0; 3, 0
The median duration of follow-up for these studies was 4.0, 3.0, 3.0, and 3.0 years for Protocol 005, Protocol 007, Protocol 013, and Protocol 015, respectively.
Cervikal intraepithelial neoplasi (CIN) grade 2/ 3 (moderat til high- grade dysplasi) og adenocarcinoma in situ (AIS) blev anvendt i de kliniske undersøgelser som en surrogatmarkør for cervikal cancer.
18 Cervical Intraepithelial Neoplasia (CIN) Grade 2/ 3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
% Effekt
%
Antal
Number Number
Antal% Effekt
Number
Antal
Efficacy***
ved
of cases of cases
tilfælde
Efficacy of cases
tilfælde
of cases
undersøgelsens
at 2 years Number
Antal Antal
Number Number at 2 years Number Number
19 Effekten af Gardasil imod HPV 6 -, 11 -, 16 -, 18- relateret VIN2/ 3 og VaIN 2/ 3 var henholdsvis 100% (95% CI:
the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related VIN2/ 3 and VaIN 2/ 3 was 100% (95% CI:
Effekten af Gardasil imod HPV 6 -, 11 -, 16 -, 18- relaterede kønsvorter var 99, 0% (95% CI:
19 the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Blandt de forsøgspersoner, som havde en abnorm Pap- test ved dag 1, som allerede var inficeret med
Among subjects with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Beskyttelse imod den generelle byrde af cervikal HPV- sygdom hos 16 til 26 år gamle kvinder
20 Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Blandt forsøgspersoner, som var naive over for 14 almindelige HPV- typer og som havde en negativ Pap- test, ved dag 1, reducerede indgivelsen af Gardasil incidensen af CIN 2/ 3 eller AIS forårsaget af vaccine - eller ikke- vaccine- HPV- typer med 42, 7% (95% CI:
Among subjects who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Gardasil reduced the incidence of CIN 2/ 3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI:
I den HPV- naive population (naive overfor 14 almindelige HPV typer og med nagativ Pap test ved dag 1) reducerede Gardasil andelen af kvinder, som blev underkastet en definitiv cervix behandlingsprocedure (Loop Electro- Excision Procedure eller koldknivs konisering) med 41, 9% (95% CI:
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Gardasil reduced the proportion of women who experienced, a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI:
De endelige resultater ved undersøgelsens afslutning for den kombinerede incidens af CIN 2/ 3 eller AIS i denne population efter en middelopfølgningstid på op til 3, 7 år er vist i tabel 3.
The final end-of-study results for the combined incidence of CIN 2/ 3 or AIS in this population after a median follow-up of 3.7 years are shown in Table 3.
21 Tabel 3:
21 Table 3:
Gardasils effekt hos yngre voksne overført til børn og unge
22 Bridging the Efficacy of Gardasil from Young Adult Women to Young Adolescents
22 Tabel 4 sammenligner anti HPV 6, 11, 16 og 18 GMT’ er 1 måned efter 3. dosis hos 9 til 15- årige drenge og piger med de tilsvarende værdier for 16 til 26- årige yngre kvinder.
Table 4 compares the 1 month Postdose 3 anti-HPV 6, 11, 16, and 18 GMTs in 9- to 15-year-old boys and girls with those in 16- to 26-year old young women.
Ved afslutning af en fase III undersøgelse var i alt 90%, 95%, 98% og 60% af de personer, der modtog Gardasil i en per- protokol immunogenicitet population, henholdsvis anti- HPV 6, anti- HPV 11, anti- HPV 16 og anti- HPV 18 seropositive.
In phase III studies, at end of study 90%, 95%, 98% and 60% of subjects who received Gardasil in the per-protocol immunogenicity population were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti HPV 18 seropositive, respectively.
De non- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af enkelt og gentagen dosistoksicitet og lokal tolerance.
23 Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
23 afkommet under drægtighedsperioden og muligvis under diegivningen.
Antibodies against all four HPV types were transferred to the offspring during gestation and possibly during lactation.
Natriumklorid, L- histidin, polysorbat 80 natriumborat, vand til injektioner
Sodium chloride L-histidine Polysorbate 80 Sodium borate Water for injections
Opbevar beholderen i den ydre karton for at beskytte mod lys.
Keep the pre-filled syringe in the outer carton in order to protect from light.
0, 5 ml suspension i en forfyldt sprøjte (type 1 glas) med stempelstopper (silikonebehandlet FluroTec- belagt brombutylelastomer eller ikke- belagt klorbutylelastomer) og hætte (brombutyl) med kanyleafskærmningsanordning (sikkerhed), uden kanyle eller med en eller to kanyler – pakkestørrelse på 1, 10 eller 20.
0.5 ml suspension in a pre-filled syringe (Type 1 glass) with plunger stopper (siliconized FluroTec- coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and tip cap (bromobutyl) with needle guard (safety) device, without needle or with one or two needle(s) - pack size of 1, 10 or 20.
0, 5 ml suspension i en forfyldt sprøjte (type 1 glas) med stempelstopper (silikonebehandlet FluroTec- belagt brombutylelastomer eller ikke- belagt klorbutylelastomer) og hætte (brombutyl) uden kanyleafskærmningsanordning (sikkerhed), uden kanyle eller med en eller to kanyler – pakkestørrelse på 1, 10 eller 20.
0.5 ml suspension in a pre-filled syringe (Type 1 glass) with plunger stopper (siliconized FluroTec- coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and tip cap (bromobutyl) without needle guard (safety) device without needle or with one or two needle(s) - pack size of 1, 10 or 20.
• Gardasil leveres i en forfyldt injektionssprøjte klar til brug til intramuskulær injektion (i. m.) fortrinsvis i deltoideaområdet på overarmen. • Hvis der medfølger 2 kanyler af forskellig længde i pakningen, skal man vælge den kanyle, hvis længde kan sikre intramuskulær injektion afhængig af patientens størrelse og vægt. • Parenterale lægemidler skal inspiceres visuelt for tilstedeværelsen af partikler og misfarvning forud for indgivelse.
Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
Bortskaf produktet, hvis der konstateres partikler, eller hvis det fremstår misfarvet.
If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’s size and weight.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.

24 Anvendelse af forfyldt injektionssprøjte med kanyleafskærmningsanordning (sikkerhed)
Parenteral drug products should be inspected visually for particulate matter and discolouration 24
Kanyleafskærmningsanordningen (sikkerhed) består af en plastcylinder (kanylafskærmning), som før indgivelse af dosis dækker sprøjtecylinderen.
The needle guard (safety) device consists of a plastic cylinder (needle guard) that, before the dose is given, covers the syringe barrel.
Kanyleafskærmningen dækker kanylen efter injektionen for at forhindre nålestiksskader.
The needle guard covers the needle after injection to prevent needle stick injury.
Når injektionen er fuldført, og stemplet er trykket helt i bund, vil stemplet aktivere aktiveringsklipsen.
When the injection is completed and the plunger is fully depressed, the plunger will engage the activation clips.
Når stemplet slippes, vil plastcylinderen hurtigt flytte sig, så den dækker kanylen.
Upon release of the plunger, the plastic cylinder will rapidly move to cover the needle.
Hvis der ikke følger en kanyle med i pakningen, skal man anvende en kanyle, som ikke er mere end 25 mm lang for at sikre, at kanylebeskyttelsen dækker kanylen fuldstændigt.
If no needle is available in the pack, use a needle not exceeding 25 mm in length to allow the needle guard to cover the needle completely.
Man skal undgå at berøre aktiveringsklipsen på anordningen (angivet med asterisker * i den første illustration), før injektionen er afsluttet, for ikke at komme til at dække kanylen med kanyleafskærmningen for tidligt.
Prior to completion of the injection, avoid contact with the activation clips (as indicated by asterisks * in the first illustration) on the device to keep from prematurely covering the needle with the needle guard.
Obs:
Note:
Sørg for at fjerne luftbobler fra sprøjten før injektion.
Ensure that the air bubbles are removed from the syringe before injection.
Etiketterne kan først fjernes efter vaccination, og når kanyleberskyttelsen dækker kanylen.
The labels can only be removed after vaccine injection and when the needle guard covers the needle.
Fjern sprøjtehætten og kanylehætten.
Remove the syringe tip cap and the needle cap.
Skru kanylen fast på sprøjtecylinderen ved at dreje den med uret mens de to anti- rotationsstop trykkes ind for at fastlåse kanylen på sprøjten.
Screw the needle onto the syringe barrel in a clockwise direction while pressing in the 2 plastic beads to lock the needle securely onto the syringe.
Fjern kanylehylstret.
Remove the needle shield.
Injicér den fulde dosis ved langsomt at trykke stemplet ind, indtil det ikke kan komme længere.
Inject the full dose by slowly pushing the plunger forward until it cannot be pushed further.
Slip ikke trykket på stemplet.
Do not release the pressure on the plunger.
Fjern sprøjten fra patienten mens trykket på stemplet opretholdes.
While maintaining pressure on the plunger, remove the syringe from the patient.