natgillin/translations-raw huggingface dataset:
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.
The immunogenicity of Silgard was assessed in 8,915 (Silgard n = 4,666; placebo n = 4,249) women 18 to 26 years of age and 3,400 female (Silgard n = 1,471; placebo n = 583) and male (Silgard n = 1,071; placebo n = 275) adolescents 9 to 17 years of age.
Imunogenost cepiva Silgard je bila ocenjena pri 8. 915 (Silgard n = 4. 666; placebo n = 4. 249) ženskah, starih od 18 do 26 let in 3. 400 mladoletnih osebah moškega (Silgard n = 1. 071; placebo n = 275) in ženskega (Silgard 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.
10 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 Silgard
Imunski odziv na cepivo Silgard
In the clinical studies, 99.9%, 99.8%, 99.8%, and 99.6% of individuals who received Silgard 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 Silgard 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.
Silgard induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Cepivo Silgard je v vseh starostnih skupinah 1 mesec po prejemu 3. odmerka povzročilo pojav visokih geometrijskih srednjih titrov anti- HPV.
Bridging the Efficacy of Silgard from Young Adult Women to Young Adolescents
Primerjava učinkovitosti cepiva Silgard pri mlajših odraslih ženskah in mlajših mladostnikih
A clinical study (Protocol 016) compared the immunogenicity of Silgard 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.
HPV 6 HPV 11 884 HPV 16 881 HPV 18 886
HPV 6
883 1038 (975, 1106) 1387 (1299, 1481) 6053 (5599, 6543) 1356 (1253, 1469)
1. 038 (975, 1. 106))
915 929 (874, 987) 915 1303 (1223, 1388) 913 4909 (4548, 5300) 920 1040 (965, 1120)
HPV 11 884 1. 387 (1. 299, 1. 481) 915
2631 543 (526, 560) 2655 762 (735, 789) 2570 2294 (2185, 2408) 2796 462 (444, 480)
HPV 18 886 1. 356 (1. 253, 1. 469) 920
10 On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old girls is inferred.
Na osnovi imunogenosti se lahko sklepa o učinkovitosti cepiva Silgard pri 9 - do 15- letnih deklicah.
Immunogenicity and safety of Silgard have been demonstrated in 9- to 15-year-old boys.
Imunogenost in varnost cepiva Silgard so dokazali pri 9 - do 15- letnih dečkih.
Persistence
11 Persistenca
In phase III studies, at end of study 90%, 95%, 98% and 60% of subjects who received Silgard 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 Silgard po per- protokolu imunogenosti v populaciji.
In addition, a subset of vaccinated individuals who received a challenge dose of Silgard 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 Silgard opazili hiter in močan anamnestični odziv, ki je presegel srednje geometrijske titre anti HPV, opažene 1 mesec po cepljenju s 3. odmerkom.
11 6.3 Shelf life
6. 3 Rok uporabnosti
Do not freeze.
12 Ne zamrzujte.
Single-dose Vial Use 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.
Uporaba enoodmerne viale S sterilno iglo in injekcijsko brizgo, ki ne vsebuje konzervansov, antiseptikov ali detergentov, iz enoodmerne viale izvlecite 0, 5 ml odmerek cepiva.
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Velika Britanija
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Silgard suspenzija za injiciranje v napolnjeni injekcijski brizgi adsorbirano rekombinantno cepivo proti humanim papilomavirusom [tipom 6, 11, 16 in 18]
Paediatric population:
14 Otroci:
The duration of protection is currently unknown.
15 Trajanje zaščite trenutno ni znano.
15 There are no safety, immunogenicity or efficacy data to support interchangeability of Silgard with other HPV vaccines.
Podatki o varnosti, imunogenosti ali učinkovitosti, ki bi podpirali zamenljivost cepiva Silgard z drugimi cepivi proti HPV, niso na voljo.
Safety was evaluated in either the entire study population (4 studies) or in a
Zaradi neželenih učinkov je bilo iz preskušanj izključenih le nekaj oseb (0, 2%).
16 predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Silgard or placebo.
Varnost so vrednotili bodisi pri celotni populaciji, vključeni v študijo (4 študije), bodisi pri vnaprej določeni podskupini (1 študija) v študijo vključene populacije, na osnovi 14- dnevnega nadzora po vsakem injiciranju cepiva Silgard ali placeba s pomočjo kartončkov za poročanje (vaccination report card (VRC) - aided surveillance).
Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
Ker so o teh neželenih učinkih poročali prostovljno in ne poznamo točne velikosti populacije, ne moremo zanesljivo oceniti njihove pojavnosti in za vse dogodke ugotoviti vzročno povezavo s cepivom.
17 4.9 Overdose
17 Bolezni prebavil: navzea, bruhanje.
There have been reports of administration of higher than recommended doses of Silgard.
Splošne težave in spremembe na mestu aplikacije: astenija, utrujenost, slabost.
18 Prophylactic Efficacy against Vaccine HPV Types (HPV 6, 11, 16, or 18)
Učinkovitost profilakse proti tipom HPV, ki jih vsebuje cepivo (HPV 6, 11, 16 ali 18)
% Number
učinkovitosti ***
Efficacy***
po 2 letih
of cases of cases
Število
Efficacy of cases
na koncu
Number at 2 years Number Number
Število
Number Number at 2 years Number Number
Število
HPV 16/ 18-related
oseb *
95.1, 99.8) and 100.0% (95% CI:
V protokolu 012 je bila učinkovitost cepiva Silgard na podlagi 6 mesečne definicije persistentne okužbe [pozitiven vzorec na dveh ali več zaporednih obiskih v vsaj 6 mesečnen razmiku (± 1 mesec)] po 4 letnem spremljanju (povprečno 3, 6 let) za HPV 16 98, 7% (95- odstotni IZ:
93.2, 100.0) for HPV 18 respectively, after a
95, 1, 99, 8), za HPV 18 pa 100, 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 (intention- 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.
23.7, 57.3) and of genital 20 warts by 82.8% (95% CI:
23, 7; 57, 3), pojavnost bradavic na spolovilih pa za 82, 8% (95 - odstotni IZ:
95% CI
95- odstotni IZ
(HPV 31/ 33/ 45/ 52/ 58) § 10 non-vaccine HPV Types║
10 tipov HPV║, ki cepivo ne vsebuje
%
24 11 15 41 30
Efficacy -13.7%
37, 5% 0, 0% 39, 9% 16, 3% - 13, 7%
95% CI < 0, 32.5†
< 0; 69, 5 < 0; 60, 7 < 0; 76, 8 < 0; 48, 5 < 0; 32, 5
Type-specific immunoassays, competitive Luminex-based immunoassay (cLIA), with type-specific standards were used to assess immunogenicity to each vaccine type.
22 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.
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
Anti-HPV responses at Month 7 among 9- to 15-year-old girls and boys were non-inferior to anti-HPV 22 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.
On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old girls is inferred.
Na osnovi imunogenosti se lahko sklepa o učinkovitosti cepiva Silgard pri 9 - do 15- letnih deklicah.
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.
Pakiranja po 1, 10 ali 20.
• Silgard is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. • 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. • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Če sta v škatli 2 različno dolgi igli, izberite tisto, ki je najprimernejša za bolnika, glede na njegovo višino in telesno maso.
The labels can only be removed after vaccine injection and when the needle guard covers the needle.
Pred injiciranjem v injekcijski brizgi ne sme biti zračnih mehurčkov. alepki lahko odstranite šele po injiciranju cepiva, ko varovalo prekrije iglo.
24 Shake well before use.
Pred uporabo dobro pretresite.
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.
EU/ 1/ 06/ 358/ 003 EU/ 1/ 06/ 358/ 004 EU/ 1/ 06/ 358/ 005 EU/ 1/ 06/ 358/ 006 EU/ 1/ 06/ 358/ 007
EU/ 1/ 06/ 358/ 003 EU/ 1/ 06/ 358/ 004 EU/ 1/ 06/ 358/ 005 EU/ 1/ 06/ 358/ 006 EU/ 1/ 06/ 358/ 007 EU/ 1/ 06/ 358/ 008 EU/ 1/ 06/ 358/ 009 EU/ 1/ 06/ 358/ 010 EU/ 1/ 06/ 358/ 011 EU/ 1/ 06/ 358/ 012 EU/ 1/ 06/ 358/ 013 EU/ 1/ 06/ 358/ 014 EU/ 1/ 06/ 358/ 015 EU/ 1/ 06/ 358/ 016
25 EU/ 1/ 06/ 358/ 008 EU/ 1/ 06/ 358/ 009 EU/ 1/ 06/ 358/ 010 EU/ 1/ 06/ 358/ 011 EU/ 1/ 06/ 358/ 012 EU/ 1/ 06/ 358/ 013 EU/ 1/ 06/ 358/ 014 EU/ 1/ 06/ 358/ 015 EU/ 1/ 06/ 358/ 016 EU/ 1/ 06/ 358/ 017 EU/ 1/ 06/ 358/ 019 EU/ 1/ 06/ 358/ 020 EU/ 1/ 06/ 358/ 021
26 EU/ 1/ 06/ 358/ 017 EU/ 1/ 06/ 358/ 019 EU/ 1/ 06/ 358/ 020 EU/ 1/ 06/ 358/ 021
26 ANNEX II
27 DODATEK II
27 A.
28 A.
Merck & Co., INC Sumneytown Pike P. O. Box 4 West Point PA 19486 USA
Merck & Co., INC Sumneytown Pike P. O. Box 4 West Point PA 19486 ZDA
The MAH must ensure that the system of pharmacovigilance, as described in version 1 (dated April 2006) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 1 (april 2006), predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
28 • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
29 Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja) • na zahtevo Evropske agencije za zdravila (EMEA).
30 A.
30 DODATEK III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – single dose vial, pack of 1, 10, 20
32 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – enoodmerna viala, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 001 – pack of 1 EU/ 1/ 06/ 358/ 002– pack of 10 EU/ 1/ 06/ 358/ 018– pack of 20
EU/ 1/ 06/ 358/ 001 – pakiranje po 1 EU/ 1/ 06/ 358/ 002 – pakiranje po 10 EU/ 1/ 06/ 358/ 018 – pakiranje po 20
IM use.
Silgard suspenzija za injiciranje i. m. uporaba
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe without needle, pack of 1, 10, 20
35 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – napolnjena injekcijska brizga brez igle, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 003 – pack of 1 EU/ 1/ 06/ 358/ 004 – pack of 10 EU/ 1/ 06/ 358/ 019 – pack of 20
EU/ 1/ 06/ 358/ 003 – pakiranje po 1 EU/ 1/ 06/ 358/ 004 – pakiranje po 10 EU/ 1/ 06/ 358/ 019 – pakiranje po 20
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with 1 needle, pack of 1, 10, 20
37 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – napolnjena injekcijska brizga z 1 iglo, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 005 – pack of 1 EU/ 1/ 06/ 358/ 006 – pack of 10 EU/ 1/ 06/ 358/ 020 – pack of 20
EU/ 1/ 06/ 358/ 005 – pakiranje po 1 EU/ 1/ 06/ 358/ 006 – pakiranje po 10 EU/ 1/ 06/ 358/ 020 – pakiranje po 20
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with 2 needles, pack of 1, 10, 20
39 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – napolnjena injekcijska brizga z 2 iglama, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 007– pack of 1 EU/ 1/ 06/ 358/ 008 – pack of 10 EU/ 1/ 06/ 358/ 021 – pack of 20
EU/ 1/ 06/ 358/ 007 – pakiranje po 1 EU/ 1/ 06/ 358/ 008 – pakiranje po 10 EU/ 1/ 06/ 358/ 021 – pakiranje po 20
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with a needle guard and no needles, pack of 1, 10, 20
41 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – napolnjena injekcijska brizga z varovalom za iglo in brez igle, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 009– pack of 1 EU/ 1/ 06/ 358/ 010 – pack of 10 EU/ 1/ 06/ 358/ 011 – pack of 20
EU/ 1/ 06/ 358/ 009 – pakiranje po 1 EU/ 1/ 06/ 358/ 010 – pakiranje po 10 EU/ 1/ 06/ 358/ 011 – pakiranje po 20
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with a needle guard and 1 needle, pack of 1, 10, 20
43 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – napolnjena injekcijska brizga z varovalom za iglo in 1 iglo, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 012– pack of 1 EU/ 1/ 06/ 358/ 013 – pack of 10 EU/ 1/ 06/ 358/ 014 – pack of 20
EU/ 1/ 06/ 358/ 012 – pakiranje po 1 EU/ 1/ 06/ 358/ 013 – pakiranje po 10 EU/ 1/ 06/ 358/ 014 – pakiranje po 20
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Silgard, suspension for injection – pre-filled syringe with a needle guard and 2 needles, pack of 1, 10, 20
45 PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI Silgard suspenzija za injiciranje – napolnjena injekcijska brizga z varovalom za iglo in 2 iglama, pakiranje po 1, 10, 20
EU/ 1/ 06/ 358/ 015– pack of 1 EU/ 1/ 06/ 358/ 016 – pack of 10 EU/ 1/ 06/ 358/ 017 – pack of 20
EU/ 1/ 06/ 358/ 015 – pakiranje po 1 EU/ 1/ 06/ 358/ 016 – pakiranje po 10 EU/ 1/ 06/ 358/ 017 – pakiranje po 20
What Silgard is and what it is used for 2.
Kaj je cepivo Silgard in za kaj ga uporabljamo 2.
Before you use Silgard 3.
Kaj morate vedeti, preden boste cepljeni s cepivom Silgard 3.
How to use Silgard 4.
Kako uporabljati cepivo Silgard 4.
How to store Silgard 6.
Shranjevanje cepiva Silgard 6.
WHAT SILGARD IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO SILGARD IN ZA KAJ GA UPORABLJAMO
Silgard produces type-specific antibodies and has been shown in clinical trials to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-26 years of age.
Cepivo Silgard povzroči nastanek tipsko specifičnih protiteles in je v kliničnih študijah preprečil s HPV 6, 11, 16 in 18 povezane bolezni pri odraslih ženskah, starih 16 do 26 let.
The most benefit from Silgard is expected before infection with any of the Human Papillomavirus types covered by the vaccine.
Največja korist cepiva Silgard se pričakuje pri osebah, ki še niso okužene z nobenim od tipov humanih papilomavirusov, ki jih vsebuje cepivo.
BEFORE YOU USE SILGARD
KAJ MORATE VEDETI, PREDEN BOSTE CEPLJENI S CEPIVOM SILGARD
Do not use Silgard if:
S cepivom Silgard se ne sme cepiti:
• is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “ other ingredients”– see section 6). • has developed an allergic reaction after receiving a dose of Silgard. • suffers from an illness with high fever.
• oseb, alergičnih na (preobčutljivih za) katerokoli zdravilno učinkovino ali drugo sestavino cepiva Silgard (navedene so pod “ Pomožne snovi so ” – glejte poglavje 6); • če se je po cepljenju s predhodnim odmerkom cepiva Silgard pojavila alergijska reakcija; • če ima oseba bolezen z močno zvišano telesno temperaturo.
You should tell your doctor if the person to be vaccinated:
50 Bodite posebno pozorni pri cepljenju s cepivom Silgard
• has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia • has a weakened immune system, for example due to a genetic defect or HIV infection
Pred cepljenjem zdravniku povejte: • če ima oseba, ki bo cepljena, motnje strjevanja krvi (bolezen, pri kateri neobičajno pogosto krvavite), na primer hemofilijo; • če ima oseba, ki bo cepljena, oslabljen imunski sistem, npr. zaradi genetske okvare ali okužbe z virusom HIV.
As with any vaccine, Silgard may not fully protect 100% of those who get the vaccine.
Kot katerokoli drugo cepivo tudi cepivo Silgard morda ne bo popolnoma zaščitilo vseh (100%) cepljenih oseb.
You should continue to follow your doctor’ s advice on cervical smear/ Pap tests and preventative and protective measures.
Še naprej morate upoštevati zdravnikova navodila o brisih materničnega vratu/ Pap testih in preventivnih ter zaščitnih ukrepih.
What other important information should I know about Silgard?
Drugi pomembni podatki o cepivu Silgard, ki jih morate poznati
Silgard can be given with Hepatitis B vaccine at a separate injection site (another part of your body, e. g. the other arm or leg) at the same visit.
Cepivo Silgard se lahko ob istem obisku da sočasno s cepivom proti hepatitisu B, vendar pa na drugo vbodno mesto (drugi del telesa, npr. v drugo roko ali nogo).
• used with medicines that suppress the immune system.
Optimalni učinek cepiva Silgard morda ne bo dosežen: • v primeru sočasne uporabe zdravil, ki zavirajo imunski sistem.
In clinical trials, oral or other contraceptives (e. g. the pill) did not reduce the protection obtained by Silgard.
Med kliničnimi preskušanji peroralni ali drugi kontraceptivi (npr. kontracepcijske tabletke) niso zmanjšali zaščite, dosežene s cepivom Silgard.
There is no information to suggest that Silgard affects your ability to drive or use machinery.
Podatkov o vplivu cepiva Silgard na sposobnost upravljanja vozil in strojev ni.
HOW TO USE SILGARD
KAKO UPORABLJATI CEPIVO SILGARD
First injection: at chosen date Second injection: ideally 2 months after first injection
Prva injekcija: ob izbranem času Druga injekcija: najbolje 2 meseca po prvi injekciji Tretja injekcija: najbolje 6 mesecev po prvi injekciji
50 Third injection: ideally 6 months after first injection
Shema cepljenja se lahko tudi nekoliko razlikuje.
If you forget to take Silgard:
Če enega odmerka cepiva Silgard niste prejeli
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
52 Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE SILGARD
SHRANJEVANJE CEPIVA SILGARD
If you have any further questions on Silgard after reading this leaflet, please ask your doctor or pharmacist.
Če imate potem, ko ste prebrali navodilo, kakršnokoli vprašanje, se posvetujte z zdravnikom ali s farmacevtom.
What Silgard contains
Kaj vsebuje cepivo Silgard
Human Papillomavirus1 Type 6 L1 protein2,3 Human Papillomavirus1 Type 11 L1 protein2,3 Human Papillomavirus1 Type 16 L1 protein2,3 Human Papillomavirus1 Type 18 L1 protein2,3 1 Human Papillomavirus = HPV 2
L1 protein2, 3 humanega papilomavirusa1 tipa 6 L1 protein2, 3 humanega papilomavirusa1 tipa 11 L1 protein2, 3 humanega papilomavirusa1 tipa 16 L1 protein2, 3 humanega papilomavirusa1 tipa 18 1 humani papilomavirus = HPV 2
1 dose of Silgard suspension for injection contains 0.5 ml.
1 odmerek cepiva Silgard suspenzija za injiciranje vsebuje 0, 5 ml suspenzije.
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Velika Britanija
Manufacturer:
53 Izdelovalec:
Slovenská republika Merck Sharp & Dohme IDEA, Inc.
54 Slovenská republika Ísland Merck Sharp & Dohme IDEA, Inc.
HPV types 16 and 18 are responsible for ~70% of cervical cancer cases and 70% of HPV-related pre-cancerous lesions of the vulva and vagina.
Te bolezni vključujejo rak materničnega vratu, predrakave spremembe na ženskih spolovilih (maternični vrat, vulva in nožnica) in bradavice na spolovilih.
HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
HPV tipa 16 in 18 sta vzrok za ~ 70% primerov raka materničnega vratu in 70% s HPV povezanih predrakavih sprememb na vulvi in nožnici, HPV tipa 6 in 11 sta odgovorna za ~ 90% primerov bradavic na spolovilih.
You should tell your doctor if the person to be vaccinated:
57 Bodite posebno pozorni pri cepljenju s cepivom Silgard
In clinical trials, oral or other contraceptives (e. g. the pill) did not reduce the protection obtained by Silgard.
• Med kliničnimi preskušanji peroralni ali drugi kontraceptivi (npr. kontracepcijske tabletke) niso zmanjšali zaščite, dosežene s cepivom Silgard.
57 Third injection: ideally 6 months after first injection
Shema cepljenja se lahko tudi nekoliko razlikuje.