natgillin/translations-raw huggingface dataset:
23.7, 57.3) and of genital warts by 82.8% (95% CI:
23, 7; 57, 3), pojavnost bradavic na spolovilih pa za 82, 8% (95- odstotni IZ:
74.3, 88.8)at end of study.
74, 3; 88, 8).
In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 2/ 3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI:
V modificirani ITT populaciji je bila korist cepiva glede na celotno pojavnost CIN 2/ 3 ali AIS (zaradi kateregakoli tipa HPV) in bradavic na spolovilih veliko manjša, in sicer se je pojavnost CIN 2/ 3 zmanjšala za 18, 4% (95- odstotni IZ:
7.0, 28.4) and 62.5% (95% CI:
7, 0; 28, 4), pojavnost AIS pa za 62, 5% (95- odstotni IZ:
54.0, 69.5), respectively, as Gardasil does not impact the course of infections or disease that are present at vaccination onset.
54, 0; 69, 5), saj cepivo Gardasil ne vpliva na potek okužbe ali bolezni, ki sta ob začetku cepljenja že prisotni.
The impact of Gardasil on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 subjects enrolled in Protocol 007, Protocols 013 and 015.
Vpliv cepiva Gardasil na delež defenitivnih terapevtskih posegov na materničnem vratu, ne glede na vzročni tip HPV, je bil ovrednoten pri 18. 150 osebah, vključenih v protokol 007, protokol 013 in protokol 015.
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:
V populaciji, ki še ni bila v stiku s HPV (negativna na 14 pogostih tipov HPV in negativen Pap test na 1. dan), je cepivo Gardasil na koncu študije zmanjšalo delež žensk, pri katerih je bil opravljen definitivni terapevtski poseg na materničnem vratu (“ Loop Electro- Excision Procedure ” ali “ Cold- Knife Conization ”) za 41, 9% (95- odstotni IZ:
27.7, 53.5) at end of study.
27, 7; 53, 5).
In the ITT population the corresponding reduction was 23.9% (95% CI:
V ITT populaciji je ustrezen delež zmanjšanja znašal 23, 9% (95- odstotni IZ:
Cross-protective efficacy The efficacy of Gardasil against CIN (any grade) and CIN 2/ 3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Učinkovitost cepiva Gardasil proti CIN (vseh stopenj) in CIN 2/ 3 ali AIS, povzročenimi z 10 tipi HPV, ki niso v cepivu (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in so strukturno podobni HPV 16 ali HPV 18 so vrednotili v kombinirani podatkovni bazi učinkovitosti študije III. faze (N = 17. 599) po
The primary analysis was done in type-specific populations that required women to be negative for the type being analyzed, but who could be positive for other HPV types (96% of the overall population).
Ženske so morale biti negativne za preiskovani tip, lahko pa so bile pozitivne za druge tipe HPV (96% celotne populacije).
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.
Končni rezultati na koncu študije za kombinirano incidenco CIN 2/ 3 ali AIS v tej populaciji po srednjem času spremljanja do 3, 7 let so prikazani v preglednici 3.
9 Table 3:
Preglednica 3:
Results for CIN 2/ 3 or AIS in Type-Specific HPV-Naïve Subjects † (end of study results) Naïve to ≥ 1 HPV Type
Rezultati za CIN 2/ 3 ali AIS pri osebah, ki še niso bile okužene s tipsko specifičnimi HPV † (rezultati ob koncu študije) Negativne za ≥ 1 tip HPV Sestavljeni opazovani
Composite Endpoint
% učinkovitosti
cases
95- odstotni IZ
cases
dogodek
% Efficacy
primeri
95% CI
primeri
(HPV 31/ 45) ‡
(HPV 31/ 45) ‡ (HPV 31/ 33/ 45/ 52/ 58)
34
34 111
60
60 150
43.2%
43, 2% 25, 8%
12.1, 63.9
12, 1; 63, 9 4, 6; 42, 5
(HPV 31/ 33/ 45/ 52/ 58) § 10 non-vaccine HPV Types ║
10 tipov HPV║, ki jih cepivo ne vsebuje
4.6, 42.5 5.1, 37.7
5, 1; 37, 7
HPV-16 related types (A9 species)
s HPV- 16 sorodni tipi (vrste A9)
9.1, 44.9
29, 1%
HPV HPV HPV HPV HPV
9, 1; 44, 9
31 33 35 52 58
HPV 31 HPV 33 HPV 35 HPV 52 HPV 58 s HPV- 18 sorodni tipi (vrste A7)
23 29 13 44 24
23 29 13 44 24 34
26.2, 74.1† < 0, 52.1† < 0, 61.9 † < 0, 44.2† < 0, 61.0†
26, 2; 74, 1 < 0; 52, 1 < 0; 61, 9 < 0; 44, 2 < 0; 61, 0 < 0; 53, 9
HPV 39 HPV 45 HPV 59
HPV 39 HPV 45 HPV 59 vrste A5 (HPV 51)
15 11 9
15 11 9 34
24 11 15
24 11 15 41
37.5% 0.0% 39.9%
37, 5% 0, 0% 39, 9% 16, 3%
< 0, 69.5† < 0, 60.7† < 0, 76.8†
< 0; 69, 5 < 0; 60, 7 < 0; 76, 8 < 0; 48, 5
A6 species (HPV 56) †
vrste A6 (HPV 56) †
< 0, 32.5†
< 0; 32, 5
The studies were not powered to assess efficacy against disease caused by individual HPV types. ‡ Efficacy was based on reductions in HPV 31-related CIN 2/ 3 or AIS § Efficacy was based on reductions in HPV 31-, 33-, 52-, and 58-related CIN 2/ 3 or AIS ║ Includes assay-identified non-vaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59.
Študije niso omogočale vrednotenja učinkovitosti proti boleznim zaradi posameznih tipov HPV. ‡ Učinkovitost temelji na zmanjšanju CIN 2/ 3 ali AIS zaradi HPV 31 § Učinkovitost temelji na zmanjšanju CIN 2/ 3 ali AIS zaradi HPV 31, 33, 52 in 58 ║ Vključuje s testom odkrite tipe HPV 31, 33, 35, 39, 45, 51, 52, 56, 58 in 59, ki jih cepivo ne vsebuje.
Immunogenicity
10 Imunogenost
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.
Imunogenost cepiva Gardasil je bila ocenjena pri 8. 915 (Gardasil n = 4. 666; placebo n = 4. 249) ženskah, starih od 18 do 26 let in 3. 400 mladoletnih osebah moškega (Gardasil n = 1. 071; placebo n = 275) in ženskega (Gardasil n = 1. 471; placebo n = 538) spola, starih od 9 do 17 let.
Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
Imunogenost vsakega od vakcinalnih tipov je bila ovrednotena s tipsko specifičnim imunskim testom (competitive Luminex- based immunoassay - cLIA), pri čemer so bili uporabljeni tipsko specifični standardi.
Immune Responses to Gardasil
Imunski odziv na cepivo Gardasil
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.
V kliničnih študijah je bilo 1 mesec po prejemu tretjega odmerka cepiva Gardasil anti- HPV 6 seropozitivnih 99, 9% oseb, anti- HPV 11 seropozitivnih 99, 8% oseb, anti- HPV 16 seropozitivnih 99, 8% oseb in anti- HPV 18 seropozitivnih 99, 6% oseb.
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.
Pri osebah, ki so prejemale placebo in so okrevale po okužbi s HPV (seropozitivne in PCR negativne) so bile vrednosti anti- HPV bistveno manjše od vrednosti, induciranih s cepivom.
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).
Pri cepljenih osebah so vrednosti anti- HPV (GMT- ji) ostale enake ali nad zaščitnim nivojem protiteles v serumu (cut- off vrednost) tudi med dolgotrajnim spremljanjem v študijah III. faze (glejte spodaj pod Persistenca).
10 Bridging the Efficacy of Gardasil from Young Adult Women to Young Adolescents
Primerjava učinkovitosti cepiva Gardasil pri mlajših odraslih ženskah in mlajših mladostnikih
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.
Klinična študija (Protokol 016) je primerjala imunogenost cepiva pri 10 - do 15- letnih dečkih in deklicah z imunogenostjo pri 16 - do 23- letnih mladostnicah in mlajših ženskah.
In the vaccine group, 99.1 to 100% became seropositive to all vaccine serotypes by 1 month Postdose 3.
V skupini, ki je dobila cepivo, jih je v enem mesecu po 3. odmerku 99, 1 do 100% postalo seropozitivnih na vse serotipe cepiva.
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.
V preglednici 4 je podana primerjava geometrijskih srednjih titrov anti- HPV 6, 11, 16 in 18 1 mesec po prejemu tretjega odmerka za 9 do 15 let stare fante in dekleta in 16 - do 26- letne mlajše ženske.
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
Primerjava imunogenosti med 9 - do 15- letnimi osebami moškega in ženskega spola ter 16 - do 26- letnimi odraslimi ženskami (per- protokol populacija) na osnovi titrov, določenih s cLIA Dekleta, stara od 16 do Dečki, stari od 9 do 15 let Deklice, stare od 9 do 15 let 26 let
9- to 15-Year-Old Males (Protocols 016 and 018) n GMT (95% CI)
(Protokola 016 in 018)
9- to 15-Year-Old Females 16- to (Protocols 016 and 018) n GMT (95% CI)
(Protokola 016 in 018)
26-Year-Old Females (Protocols 013 and 015) n GMT (95% CI)
(Protokola 013 in 015)
HPV 6 HPV 11 884 HPV 16 881 HPV 18 886
HPV 11 884 1. 387 (1. 299, 1. 481) 915
883 1038 (975, 1106) 1387 (1299, 1481) 6053 (5599, 6543) 1356 (1253, 1469)
1. 303 (1. 223, 1. 388)
915 929 (874, 987) 915 1303 (1223, 1388) 913 4909 (4548, 5300) 920 1040 (965, 1120)
HPV 18 886 1. 356 (1. 253, 1. 469) 920
2631 543 (526, 560) 2655 762 (735, 789) 2570 2294 (2185, 2408) 2796 462 (444, 480)
462 (444, 480)
GMT- Geometric mean titre in mMU/ ml (mMU = milli-Merck units)
GST - Geometrijski srednji titer v mMe/ ml (mMe= mili- Merck enote)
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.
Pri 9 - do 15- letnih deklicah in dečkih so bili anti HPV odzivi v 7. mesecu enakovredni anti- HPV odzivom pri 16 - do 26- letnih mlajših ženskah, pri katerih je bila učinkovitost dokazana v študijah III. faze.
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.
V 7. mesecu so bile vrednosti anti- HPV znatno večje pri osebah, mlajših od 12 let, kot pa pri osebah, starejših od 12 let.
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old girls is inferred.
11 Na osnovi imunogenosti se lahko sklepa o učinkovitosti cepiva Gardasil pri 9 - do 15- letnih deklicah.
Immunogenicity and safety of Gardasil have been demonstrated in 9- to 15-year-old boys.
Imunogenost in varnost cepiva Gardasil so dokazali pri 9 - do 15- letnih dečkih.
Protective efficacy has not been evaluated in males.
Študije učinkovitosti zaščite pri moških niso bile izvedene.
Persistence
Persistenca
In Protocol 007 peak anti-HPV 6, 11, 16, 18 GMTs were observed at Month 7.
V Protokolu 007 so v 7. mesecu opazili najvišje srednje geometrijske titre anti HPV 6, 11, 16 in 18.
The GMTs declined through Month 24 and then stabilized until at least Month 60.
Srednji geometrijski titri so se zmanjševali do 24. meseca po cepljenju, nato pa so se najpozneje v 60. mesecu ustalili.
The exact duration of immunity following a 3-dose series has not been established.
Natančno trajanje imunosti po prejemu vseh 3 odmerkov cepiva ni bilo ugotovljeno.
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.
V študijah III. faze je bilo ob koncu študije anti- HPV 6 seropozitivnih 90% oseb, anti- HPV 11 seropozitivnih 95% oseb, anti- HPV 16 seropozitivnih 98% oseb in anti- HPV 18 seropozitivnih 60% oseb, ki so prejele cepivo Gardasil po per- protokolu imunogenosti v populaciji.
Subjects who were seronegative for anti-HPV 6, 11, 16, 18 in the cLIA at end of study were still protected against clinical disease.
Osebe, ki so bile anti - HPV 6, 11, 16, 18 seronegativne v testu cLIA, so bile ob koncu študije še vedno zaščitene pred klinično boleznijo.
Evidence of an anamnestic response was seen in vaccinated individuals who were seropositive to relevant HPV type(s) prior to vaccination.
Dokaz anamnestičnega odziva so zasledili pri cepljenih osebah, ki so bile pred cepljenjem seropozitivne na relevantni tip (relevantne tipe) HPV.
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.
Razen tega so pri cepljenih osebah, ki so 5 let po začetku cepljenja prejele obnovitveni odmerek cepiva Gardasil opazili hiter in močan anamnestični odziv, ki je presegel srednje geometrijske titre anti HPV, opažene 1 mesec po cepljenju s 3. odmerkom.
Evaluation of pharmacokinetic studies is not required for vaccines.
Vrednotenje farmakokinetičnih lastnosti za cepiva ni zahtevano.
11 Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Študije toksičnosti pri enkratnem in ponavljajočih se odmerkih ter tolerančne študije ne kažejo posebnega tveganja za človeka.
Sodium chloride L-histidine Polysorbate 80 Sodium borate Water for injections
natrijev klorid L- histidin polisorbat 80 natrijev borat voda za injekcije
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.
0, 5 ml suspenzije v viali (steklo tipa 1) z zamaškom (s FluroTec- om ali teflonom obloženi klorobutilni elastomer) in plastičnim pokrovčkom (z aluminijastim obročkom) v pakiranju po 1, 10 ali 20.
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.
S sterilno iglo in injekcijsko brizgo, ki ne vsebuje konzervansov, antiseptikov ali detergentov, iz enoodmerne viale izvlecite 0, 5 ml odmerek cepiva.
Once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Ko ste enoodmerno vialo prebodli, morate cepivo nemudoma aplicirati, vialo pa zavreči.
Any unused product or waste material should be disposed of in accordance with local requirements.
Odstranjevanje Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F- 69007 Lyon, Francija
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Gardasil suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
3 adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al).
L1 protein v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C- 5 (sev 1895)) 3 adsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (225 mikrogramov Al)
14 Paediatric population:
14 Otroci:
Sustained protective efficacy has been observed for 15 4.5 years after completion of the 3-dose series.
Ugotovljena je bila persistentna zaščitna učinkovitost, ki je trajala 4, 5 let po dokončanju cepljenja s 3 odmerki.
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.
V 5 kliničnih preskušanjih (4 nadzorovanih s placebom) so osebe cepivo Gardasil ali placebo prejele na dan vključitve in nato približno čez 2 in 6 mesecev.
Gastrointestinal disorders: nausea, vomiting.
17 Bolezni prebavil: navzea, bruhanje.
17 General disorders and administration site conditions: asthenia, fatigue, malaise.
Splošne težave in spremembe na mestu aplikacije: astenija, utrujenost, slabost.
The efficacy for all other endpoints is based on protocols 007, 013, and 015.
18 temelji na protokolih 007, 013 in 015.
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.
V kliničnih preskušanjih sta bila cervikalna intraepitelijska neoplazija (CIN) stopnje 2/ 3 (displazija zmerne do hude stopnje) in adenokarcinom in situ (AIS) uporabljena kot nadomestna klinična označevalca raka materničnega vratu.
At end of study and in the combined protocols,
19 Ob koncu študije in v kombinaciji protokolov je bila
19 the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
učinkovitost cepiva Gardasil proti s HPV 6, 11, 16 in 18 povezanimi bradavicami 99, 0% (95- odstotni IZ:
The modified intention to treat (ITT) population included women regardless of baseline HPV status at Day 1, who received at least one vaccination and in whom case counting started at 1 month Postdose 1.
Modificirana ITT (intetion- to- treat) populacija je vključevala ženske ne glede na HPV status na 1. dan, ki so prejele vsaj en odmerek cepiva, štetje primerov pa se je začelo 1 mesec po cepljenju s 1. odmerkom.
20 Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Zaščita pred celotnim bremenom bolezni materničnega vratu zaradi HPV pri ženskah, starih od 16 do 26 let
21 Table 3:
Preglednica 3:
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.
22 Imunogenost cepiva Gardasil je bila ocenjena pri 8. 915 (Gardasil n = 4. 666; placebo n = 4. 249) ženskah, starih od 18 do 26 let in 3. 400 mladoletnih osebah moškega (Gardasil n = 1. 071; placebo n = 275) in ženskega (Gardasil n = 1. 471; placebo n = 538) spola, starih od 9 do 17 let.
22 Bridging the Efficacy of Gardasil from Young Adult Women to Young Adolescents
Primerjava učinkovitosti cepiva Gardasil pri mlajših odraslih ženskah in mlajših mladostnikih
On the basis of this immunogenicity bridging, the efficacy of Gardasil in 9- to 15-year-old girls is inferred.
Na osnovi imunogenosti se lahko sklepa o učinkovitosti cepiva Gardasil pri 9 - do 15- letnih deklicah.
Persistence
23 Persistenca
23 Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Študije toksičnosti pri enkratnem in ponavljajočih se odmerkih ter tolerančne študije ne kažejo posebnega tveganja za človeka.
6.4 Special precautions for storage
24 6. 4 Posebna navodila za shranjevanje
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.
Pakiranja po 1, 10 ali 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.
Pakiranje po 1, 10 ali 20.
Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
Gardasil je na voljo v napolnjeni injekcijski brizgi, pripravljeni za intramuskularno (i. m.) aplikacijo, najbolje v deltoidni predel nadlakti.
Parenteral drug products should be inspected visually for particulate matter and discolouration 24
Zdravila za parenteralno uporabo morate pred dajanjem vizualno pregledati glede delcev ali spremembe barve.
Using the pre-filled syringe with needle guard (safety) device
Uporaba napolnjenih injekcijskih brizg, opremljenih z varovalom (zaščito) za iglo
The needle guard (safety) device consists of a plastic cylinder (needle guard) that, before the dose is given, covers the syringe barrel.
Varovalo (zaščita) za iglo ima plastičen cilinder (varovalo), ki pred injiciranjem obdaja injekcijsko brizgo.
The needle guard covers the needle after injection to prevent needle stick injury.
Varovalo tako po injiciranju obdaja iglo in ščiti pred morebitnimi poškodbami z njo.
When the injection is completed and the plunger is fully depressed, the plunger will engage the activation clips.
Ko je injiciranje končano, mora biti bat injekcijske brizge popolnoma sproščen, kar omogoča, da se zatiča aktivirata.
Upon release of the plunger, the plastic cylinder will rapidly move to cover the needle.
Po sprostitvi bata bo plastični pokrovček nemudoma prekril iglo.
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.
Če v škatli igla ni priložena, uporabite iglo, ki ni daljša od 25 mm, da jo varovalo po injiciranju lahko popolnoma prekrije.
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.
Dokler z injiciranjem ne končate, pazite, da se ne dotaknete zatičev (na prvi sliki sta označena z *), sicer lahko sprostite varovalo.
Ensure that the air bubbles are removed from the syringe before injection.
Pred injiciranjem v injekcijski brizgi ne sme biti zračnih mehurčkov.
The labels can only be removed after vaccine injection and when the needle guard covers the needle.
Nalepki lahko odstranite šele po injiciranju cepiva, ko varovalo prekrije iglo.
Remove the syringe tip cap and the needle cap.
Odstranite pokrov injekcijske brizge in igle.
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.
Medtem ko pritiskate na oba jezička, v smeri urinega kazalca privijte iglo na injekcijsko brizgo, da se igla zaskoči.
Remove the needle shield.
25 Odstranite zaščito igle.
Inject the full dose by slowly pushing the plunger forward until it cannot be pushed further.
Celotni odmerek injicirajte tako, da pritiskate bat, dokler gre.
Do not release the pressure on the plunger.
Ne prenehajte pritiskati na bat.
Release the plunger slowly.
Šele sedaj počasi sprostite bat.
The needle guard will rapidly move to cover the needle.
Varovalo igle bo tako nemudoma prekrilo iglo.
25 To remove the detachable labels, rotate the plunger until the coloured tab becomes visible.
Za odstranitev nalepk vrtite bat dokler se ne pokaže obarvana oznaka.
Pull on the coloured tab while continuing to rotate the plunger as needed.
Medtem ko vlečete za obarvano oznako, obračajte bat in odlepite nalepko.
Using the pre-filled syringe without needle guard (safety) device
Uporaba napolnjenih injekcijskih brizg, ki niso opremljene z varovalom (zaščito) za iglo
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Iglo pritrdite tako, da jo zavrtite v smeri urinega kazalca, dokler ni zanesljivo pritrjena na injekcijsko brizgo.
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27 A.
27 DODATEK II