natgillin/translations-raw huggingface dataset:
Silapo 1000 IU/0.3ml solution for injection in pre-filled syringe Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe Silapo 6000 IU/0.6ml solution for injection in pre-filled syringe Silapo 8000 IU/0.8ml solution for injection in pre-filled syringe Silapo 10000 IU/1.0ml solution for injection in pre-filled syringe Silapo 20000 IU/0.5ml solution for injection in pre-filled syringe Silapo 30000 IU/0.75ml solution for injection in pre-filled syringe Silapo 40000 IU/1.0ml solution for injection in pre-filled syringe
Silapo 1. 000 i. e. / 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 2. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 3. 000 i. e. / 0, 9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 4. 000 i. e. / 0, 4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 5. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 6. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 8. 000 i. e. / 0, 8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 10. 000 i. e. / 1, 0 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 20. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 30. 000 i. e. / 0, 75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Silapo 40. 000 i. e. / 1, 0 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
What Silapo is and what it is used for 2.
Kaj je zdravilo SILAPO in za kaj ga uporabljamo 2.
Before you use Silapo 3.
Kaj morate vedeti, preden boste uporabili zdravilo SILAPO 3.
How to use Silapo 4.
Kako uporabljati zdravilo SILAPO 4.
How to store Silapo 6.
Shranjevanje zdravila zdravila Silapo 6.
WHAT SILAPO IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO SILAPO IN ZA KAJ GA UPORABLJAMO
Silapo is a medicine that stimulates the bone marrow to produce more red blood cells.
Zdravilo Silapo je zdravilo, ki stimulira kostni mozeg, da tvori več rdečih krvnih celic.
BEFORE YOU USE SILAPO
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO SILAPO
Do not use Silapo
Ne uporabljajte zdravila Silapo
− if you are allergic (hypersensitive) to erythropoietins or any of the other ingredients of Silapo − if you have developed Pure Red Cell Aplasia (PRCA; reduced or stopped production of red blood cells) following treatment with any erythropoietin − if you have high blood pressure, which is not properly controlled with blood pressure-lowering medicines − if you cannot be given medicines to thin blood for the prevention of blood clots − if you are donating your own blood before surgery, and:
− če ste alergični na (preobčutljivi za) eritropoetine ali katerokoli sestavino zdravila Silapo. − če po zdravljenju z eritropoetinom dobite čisto aplazijo rdečih krvnih celic (PRCA; zmanjšano ali ustavljeno nastajanje rdečih krvnih celic). − če imate visok krvni tlak, ki ga z zdravili za znižanje krvnega tlaka ni možno kontrolirati. − če ne smete jemati zdravil za redčenje krvi, ki preprečijo nastanek krvnih strdkov. − če pred operacijo darujete svojo lastno kri in:
Take special care with Silapo
Bodite posebno pozorni pri uporabi zdravila Silapo
Your doctor will monitor your blood pressure regularly while you are using Silapo.
Vaš zdravnik Vam bo med uporabo zdravila Silapo redno meril krvni tlak.
Remember to tell your doctor that you are receiving Silapo if you have to visit the hospital or family doctor for any treatmentincluding a blood test, as Silapo may affect the results.
Če morate v bolnico ali k svojemu družinskemu zdravniku zaradi zdravljenja, ki vključuje krvne teste, povejte zdravniku, da jemljete zdravilo Silapo, ker lahko zdravilo Silapo vpliva na rezultate.
Kidney disease patients There is no experience with subcutaneous use (injection into the skin) of Silapo in kidney patients.
Ledvični bolniki Izkušenj s subkutano uporabo (injiciranje pod kožo) zdravila Silapo pri ledvičnih bolnikih ni.
Therefore, if you are being treated for anaemia associated with kidney disease, Silapo has to be given by injection into a vein (intravenously).
Zato vam morajo v primeru, da Vas zdravijo za anemijo zaradi bolezni ledvic, zdravilo Silapo dajati z injekcijo v veno (intravensko).
PRCA
Če pride do tega, je posledica resna anemija, s simptomi, kot so neobičajna utrujenost, vrtoglavica in
185 may be caused by the production to antibodies against the erythropoietin product and, in the following, to your own erythropoietin.
Do PRCA lahko pride zaradi tvorjenja protiteles proti eritropoetinu v zdravilu in posledično proti Vašemu lastnemu eritropoetinu.
If PRCA, a very rare condition, occurs, the Silapo therapy will be stopped and your doctor will determine the best course of action to treat the anaemia.
Če pride do PRCA, zelo redkega stanja, se bo zdravljenje z zdravilom Silapo prekinilo in Vaš zdravnik bo odločil, kaj bo najboljši način za zdravljenje anemije.
If you are receiving dialysis treatment when you begin treatment with Silapo, your dialysis regimen may need to be adjusted to maintain urea, creatinine and potassium levels in the desired range.
Če ste ob začetku zdravljenja z zdravilom Silapo na dializi, bo mogoče treba popraviti Vaš urnik na dializi, da sečnina, kreatinin in kalij ostanejo v želenih mejah.
Cancer patients Cancer patients are more likely to suffer from blood clots if receiving erythropoietin medicines, like Silapo (see section 4).
Bolniki z rakom Pri bolniki z rakom, ki prejemajo zdravila z eritropoetinom, kot je zdravilo Silapo, se bolj pogosto pojavijo krvni strdki (glej poglavje 4).
In particular, if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant, your doctor may order special blood tests to measure ciclosporin levels while you are taking Silapo.
V primeru, da jemljete zdravilo, ki vsebuje zdravilno učinkovino ciklosporin, s katerim se po transplantaciji ledvic zavira imunaki sistem, Vam bo zdravnik morda predpisal posebno teste krvi, s katerimi se med jemanjem zdravila Silapo meri koncentracija ciklosporina.
186 Pregnancy and breast-feeding
186 Nosečnost in dojenje
Silapo has no or negligible effect on the ability to drive and use machines.
Zdravilo Silapo nima oziroma ima zanemarljiv vpliv na sposobnost za vožnjo in upravljanje s stroji.
Important information about some of the ingredients of Silapo
Pomembna informacija o nekaterih sestavinah zdravila Silapo
HOW TO USE SILAPO
KAKO UPORABLJATI ZDRAVILO SILAPO
Always use Silapo exactly as your doctor has told you.
Zdravilo Silapo uporabljajte vedno natančno tako, kot Vam je rekel zdravnik.
He/she will work out the correct dose of Silapo for you to use, how long the treatment should continue and by what route the medicine will be given.
Določil( a) bo pravilni odmerek zdravila Silapo za Vas, kako dolgo bo zdravljenje trajalo in na kakšen način boste zdravilo prejemali.
The usual starting dose of Silapo is 50 IU/kg (International Units per kilogram).
Običajni začetni odmerek je 50 i. e. / kg (mednarodnih enot na kilogram).
187 The dose for children and adolescents is based on body weight in kilograms.
187 Zdravilo Silapo se daje po dializi.
The usual starting dose is 50 IU/ kg.
Običajni začetni odmerek je 50 i. e. / kg.
Use in adult patients with kidney disease but not receiving dialysis The usual starting dose is 50 IU/kg.
Uporaba pri odraslih bolnikih z boleznijo ledvic, ki niso na dializi Običajni začetni odmerek je 50 i. e. / kg.
Use in adult patients receiving chemotherapy Your doctor may initiate treatment with Silapo if your haemoglobin level is 10 g/dl or less.
Uporaba pri odraslih bolniki na kemoterapiji Vaš zdravnik lahko uvede zdravljenje z zdravilom Silapo, če znaša vaša koncentracija hemoglobina 10 g/ dl ali manj.
The starting dose may be adjusted by your doctor depending on how your anaemia responds to treatment; you will usually receive Silapo until 1 month after the end of chemotherapy.
Običajno dobivate zdravilo Silapo še en mesec po zaključku kemoterapije.
If Silapo is injected under the skin for anaemia not associated with kidney disease the amount injected in any one place should not exceed 1 ml.
Če si zdravilo Silapo injicirate pod kožo za anemija, ki je povezana z boleznijo ledvic, se na enem mestu ne sme injicirati več kot 1 ml.
Always follow these instructions when using Silapo:
188 Kadar uporabljate zdravilo Silapo, se vedno držite teh navodil:
• the blister sealing is broken or the blister is damaged in any way • the liquid is coloured or you can see particles floating in it • any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister • you know or think it may have been accidentally frozen
Zdravila Silapo se ne sme uporabljati, • če je pečat na ovojnini pretrgan ali če je ovojnina na kakršenkoli način poškodovana • če je tekočina obarvana ali če je videti v njej plavati delce • če je iz vnaprej napolnjene brizge iztekla tekočina ali če je v zavarjenem blistru videti kondenzacijo. • če je bila po nesreči zamrznjena
Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection) Once your condition is controlled you will receive regular doses of Silapo.
Menjava med injiciranjem v žilo in pod kožo (med intravenskim in subkutanim injiciranjem) Ko bo Vaše stanje pod nadzorom, boste začeli dobivati običajne odmerke zdravila Silapo.
If your anaemia is not associated with kidney disease, your doctor may decide that it is better for you to receive Silapo by injection under the skin (subcutaneous) rather than into a vein (intravenous).
V kolikor anemija ni povezana z boleznijo ledvic, bo Vaš zdravnik odločil, ali je za Vas bolje, če zdravilo Silapo dobivate s subkutano (subkutano) injekcijo ali z injekcijo v veno (intravensko).
Injecting Silapo under the skin yourself for anaemia not associated with kidney disease At the start of your therapy, Silapo is injected by medical or nursing staff.
Kako si sami injicirate zdravilo Silapo pod kožo pri anemiji, ki ni povezana z boleznijo ledvic Ob začetku Vaše terapije Vam bodo zdravilo Silapo injicirali medicinske sestre ali zdravnik.
If you use more Silapo than you should
Če ste uporabili večji odmerek zdravila Silapo, kot bi smeli:
You should inform the doctor or nurse immediately if you think too much Silapo has been injected.
Svojega zdravnika ali medicinsko sestro morate nemudoma obvestiti, če mislite, da Vam je bilo injicirano preveč zdravila Silapo.
If you forget to use Silapo
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmere.
Do not use a double dose to make up for a forgotten dose.
Če ste prenehali uporabljati zdravilo Silapo
If you stop using Silapo Do not to stop the treatment without consultation of your doctor.
Zdravljenja ne prekinjajte brez posveta z zdravnikom.
Like all medicines, Silapo can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Silapo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Other side effects:
189 Drugi neželeni učinki:
PRCA means the inability to produce enough red blood cells in the bone (see section “Take special care with Silapo”).
- Poročali so o redkih primerih preobčutljivostnih reakcij, vključno z zatekanjem, predvsem okoli
Your doctor may monitor your blood pressure regularly while you are using Silapo, particularly at the start of therapy. – Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if you have low blood pressure or if your arteriovenous fistula has complications.
PRCA pomeni nezmožnost nastajanja zadostnega števila rdečih krvnih celic v kosteh (glejte poglavje » Bodite posebno pozorni pri uporabi zdravila Silapo «).
Cancer patients – blood clotting (thrombotic vascular events) (see section “Take special care with Silapo”). – increase of blood pressure.
- Možna je obstrukcija spoja med arterijo in veno (tromboza šanta), še posebej, če imate nizek
Therefore your haemoglobin-levels and your blood pressure should be controlled.
Zdravnik bo morda pregledal šant in predpisal zdravilo za preprečevanje tromboze.
HOW TO STORE SILAPO
SHRANJEVANJE ZDRAVILA SILAPO
Do not use Silapo after the expiry date which is stated on the label and the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Injekcijsko brizgo lahko vzamete iz hladilnika in jo nato hranite pri sobni temperaturi (do 25 ºC), vendar največ 3 dni.
The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
Napolnjeno injekcijsko brizgo shranjujemo v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
– The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Zdravilna učinkovina je je epoetin zeta (pridobljen iz celične linije jajčnika kitajskega hrčka – (CHO – ” Chinese Hamster Ovary ”) s tehnologijo rekombinantne DNA.
Silapo 1000 IU/0.3ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 1. 000 i. e. / 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 1. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 2. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 6 ml raztopine za injiciranje vsebuje 2. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 3. 000 i. e. / 0, 9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 9 ml raztopine za injiciranje vsebuje 3. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 4. 000 i. e. / 0, 4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 4 ml raztopine za injiciranje vsebuje 4. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Raztopina vsebuje 10. 000 i. e. epoetina zeta na ml.
The solution contains 10000 IU Epoetin zeta per ml.
Silapo 6. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 6 ml raztopine za injiciranje vsebuje 6. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 8000 IU/0.8ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 8. 000 i. e. / 0, 8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 8 ml raztopine za injiciranje vsebuje 8. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 10000 IU/1.0ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 10000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 10. 000 i. e/ 1, 0 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 1, 0 ml raztopine za injiciranje vsebuje 10. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 20000 IU/0.5ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 20. 000 i. e. / 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 5 ml raztopine za injiciranje vsebuje 20. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Silapo 30000 IU/0.75ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 30. 000 i. e. / 0, 75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 0, 75 ml raztopine za injiciranje vsebuje 30. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
191 Silapo 40000 IU/1.0ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 40000 international units (IU) epoetin zeta (recombinant human erythropoietin).
191 Silapo 40. 000 i. e. / 1, 0 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga z 1, 0 ml raztopine za injiciranje vsebuje 40. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
Pomožne snovi so dinatrijev fosfat dihidrat, natrijev dihidrogen fosfat dihidrat, natrijev klorid, kalcijev klorid dihidrat, polisorbat 20, glicin, levcin, izolevcin, treonin, glutamatna kislina, fenilalanin, voda za injekcije, natrijev hidroksid (za prilagoditev pH), Klorovodikova kislina (za prilagoditev pH).
Silapo is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Napolnjena je v napolnjene injekcijske brizge s fiksno injekcijsko iglo.
The pre-filled syringes contain between 0.3 and 1.0 ml solution, depending on the content of epoetin zeta (see “What Silapo contains”).
Vnaprej napolnjene brizge vsebujejo med 0, 3 in 1, 0 ml raztopine, odvisno od vsebnosti epoetin zeta (glejte "Kaj vsebuje zdravilo Silapo").
One pack contains 1, 4 or 6 pre-filled syringes.
Vsako pakiranje vsebuje 1, 4 do 6 vnaprej napolnjenih brizg.
52 D-61118 Bad Vilbel Tel: +49 (0) 6101 30 42 0 Fax: +49 (0) 6101 30 42 11
52 D- 61118 Bad Vilbel Tel: +49 (0) 6101 30 42 0 Faks: +49 (0) 6101 30 42 11
What is Silgard used for?
Kaj je zdravilo Silgard?
Silgard is used to vaccinate against precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina), cancer of the cervix and genital warts that are caused by infection with the human papillomavirus (HPV) types 6, 11, 16 or 18. The effectiveness of Silgard has been studied in women aged 16 to 26 years, and its immunogenicity (its ability to make the immune system respond to the viruses) has been studied in children and adolescents aged nine to 15 years.
Učinkovitost zdravila Silgard so preučevali pri ženskah, starih od 16 do 26 let, njegovo imunogenost (sposobnost, da vzbudi odziv imunskega sistema) pa so preučevali pri deklicah in mladostnicah, starih od 9 do 15 let.
How is Silgard used?
Kako se zdravilo Silgard uporablja?
Silgard is given to individuals aged nine years or over, as three doses, with two months between the first and second doses, and four months between the second and third doses.
Zdravilo Silgard se daje posameznicam, starim devet let ali več, v obliki treh odmerkov, pri čemer sledi drugi odmerek dva meseca po prvem, tretji pa štiri mesece po drugem.
It is recommended that individuals who receive the first dose of Silgard should complete all three doses with Silgard.
Priporočeno je, da posameznica, ki prejme prvi odmerek zdravila Silgard, prejme vse tri odmerke zdravila Silgard.
Silgard contains the purified L1 proteins for four of the types of human papillomavirus: types 6, 11, 16, and 18.
Zdravilo Silgard vsebuje prečiščene beljakovine L1 za štiri tipe humanih papilomavirusov: tipe 6, 11, 16 in 18.
The proteins in Silgard are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the L1 proteins.
Ti
Reproduction is authorised provided the source is acknowledged. recognise them easily). The vaccine also contains an ‘ adjuvant ’ (a compound containing aluminium) to stimulate a better response.
Reproduction is authorised provided the source is acknowledged. tvorijo virusu podobne delce (strukture, ki so podobne virusu HPV, tako da jih telo zlahka prepozna).
When a patient is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these proteins.
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za stimulacijo boljšega odziva.
The antibodies help to block the virus from entering cells in the body.
Ko bolnik prejme cepivo, prične imunski sistem (sistem, ki ščiti telo pred boleznimi) tvoriti protitelesa za te beljakovine.
The effects of Silgard were first tested in experimental models before being studied in humans.
Učinki zdravila Silgard so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Silgard was compared with placebo (a dummy vaccine).
Zdravilo Silgard so primerjali s placebom (cepivom brez zdravilne učinkovine).
Silgard was effective against precancerous genital lesions of the cervix, vulva and vagina, cervical cancer, and warts related to HPV types 6, 11, 16 and 18.
Zdravilo Silgard je bilo učinkovito proti predrakavim genitalnim lezijam materničnega vratu, zunanjega in notranjega ženskega spolovila, raku materničnega vratu in bradavicam na spolovilih, povezanim s HPV tipov 6, 11, 16 in 18.
Looking at the results of all four studies together, in women who had never been infected by HPV types 6, 11, 16 or 18 before, and who received the full course of vaccination, one woman out of over 8,000 vaccinated with Silgard developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Skupna obravnava rezultatov vseh štirih študij je pokazala, da so se v skupini žensk, ki predhodno niso bile okužene s HPV tipov 6, 11, 16 in 18 in ki so prejele celoten ciklus cepljenja, pri eni bolnici od več kot 8000 žensk, cepljenih z zdravilom Silgard, pojavile predrakave lezije na materničnem vratu, ki bi lahko bile povezane s HPV tipov 16 ali 18.
A similar effect of Silgard was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Podoben učinek zdravila Silgard so opazili v analizi, ki je vključevala tudi lezije materničnega vratu, povzročene z okužbo z drugima dvema tipoma HPV (tipoma 6 in 11).
Two women out of almost 8,000 in the Silgard group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Pri dveh bolnicah med skoraj 8000 ženskami v skupini, ki je prejemala zdravilo Silgard, so se pojavile bradavice na spolovilih, ni pa bilo primerov predrakavih lezij na zunanjem ali notranjem spolovilu.