natgillin/translations-raw huggingface dataset:
* Post-Marketing adverse events (frequency cannot be estimated from the available data).
* Neželeni učinki v obdobju trženja zdravila (pogostnosti ni mogoče oceniti iz razpoložljivih
Impact on Biopsy and Definitive Therapy Procedures
Vpliv na postopke biopsije in dokončnega zdravljenja
Seroconversion to all four antigens occurred in more than ninety-six percent of the subjects.
Serokonverzija za vse štiri antigene se je pojavila pri več kot 96 odstotkih oseb.
Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Opomba: Ocenjene vrednosti in intervali zaupanja so prilagojeni glede na čas spremljanja osebe.
What Silgard is and what it is used for What you need to know before you receive Silgard
Kaj je cepivo Silgard in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli cepivo Silgard
n % of seropositive subjects
n % seropozitivnih oseb
The use of Silgard should be in accordance with official recommendations.
Cepivo Silgard je treba uporabljati v skladu z uradnimi priporočili.
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin
Talk to your doctor, pharmacist or nurse before vaccination if you or your child
Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate vi ali vaš otrok:
The primary time point analysis after 3 years did not reach statistical significance for all pre-specified endpoints.
Primarna analiza vseh vnaprej določenih opazovanih dogodkov po 3 letih ni dosegla statistične značilnosti.
MSM are at higher risk of anal HPV infection compared to the general population; the absolute benefit of vaccination in terms of prevention of anal cancer in the general population is expected to be very low.
Populacija MSM ima večje tveganje za analno okužbo s HPV kot splošna populacija; za absolutno korist cepljenja za preprečevanje analnega raka v splošni populaciji se pričakuje, da je zelo majhna.
Use of hormonal contraceptives did not appear to affect the immune response to Silgard.
Kaže, da uporaba hormonskih kontraceptivov ni vplivala na imunski odziv na cepivo Silgard.
These adverse reactions usually were mild or moderate in intensity.
Ti neželeni učinki so bili po navadi blagi ali zmerni.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Ker gre za učinke, poročane prostovoljno in iz populacije, katere velikost je negotova, ni vedno mogoče zanesljivo oceniti njihove pogostnosti ali ugotoviti vzročne povezanosti z izpostavljenostjo cepivu.
Silgard may not have an optimal effect if: • 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.
Efficacy results are presented for the combined analysis of study protocols.
Na voljo so rezultati o učinkovitosti iz združene analize študijskih protokolov.
Therefore, vaccinees should be observed for approximately 15 minutes after vaccine administration.
Zato je treba cepljene osebe po cepljenju opazovati približno 15 minut.
• has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
• motnje strjevanja krvi (bolezen, pri kateri neobičajno pogosto krvavite), na primer hemofilijo;
Therefore, it is important that the same vaccine should be prescribed for the whole dose regimen.
Zato je pomembno, da se pri celotni shemi odmerjanja uporablja enako cepivo.
The data on Silgard administered during pregnancy did not indicate any safety signal.
Podatki o uporabi cepiva Silgard med nosečnostjo niso pokazali nobenega signala glede varnosti.
Silgard may be given to women who are breast-feeding or intend to breast-feed.
Cepivo Silgard se lahko daje ženskam, ki dojijo ali nameravajo dojiti.
These data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity.
Ti podatki o nosečnicah (več kot 1.000 izpostavljenih izidov) ne kažejo malformacijskih učinkov ali toksičnih učinkov na plod/novorojenčka.
During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy.
Med programom kliničnega razvoja so pri 3.819 ženskah (cepivo = 1.894, placebo = 1.925) poročali o vsaj eni nosečnosti.
• you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Silgard (listed under “other ingredients”- see section 6).
• če ste vi ali vaš otrok alergični (preobčutljivi) na katero koli zdravilno učinkovino ali drugo sestavino cepiva Silgard (navedene so pod “Pomožne snovi so”- glejte poglavje 6);
This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Spremlja jo lahko več nevroloških znakov, kot so prehodne motnje vida, parestezija in tonično-klonični gibi udov med okrevanjem.
• Second injection: 2 months after first injection
• Druga injekcija: 2 meseca po prvi injekciji
What Silgard is and what it is used for
Kaj je cepivo Silgard in za kaj ga uporabljamo
Safety and immunogenicity of the vaccine have been assessed in individuals aged from 7 to 12 years who are known to be infected with human immunodeficiency virus (HIV) (see section 5.1).
Varnost in imunogenost cepiva sta bili ovrednoteni pri posameznikih, starih od 7 do 12 let, za katere je bilo znano, da so okuženi z virusom humane imunske pomanjkljivosti (HIV) (glejte poglavje 5.1).
The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Cepivo morate uporabiti kot je pripravljeno; dodatno redčenje ali rekonstitucija nista potrebni.
In 7 clinical trials (6 placebo-controlled), individuals were administered Silgard or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
V 7 kliničnih preskušanjih (6 nadzorovanih s placebom) so osebe cepivo Silgard ali placebo prejele na dan vključitve in nato približno čez 2 in 6 mesecev.
Administer the entire dose as per standard protocol.
Aplicirajte celotni odmerek cepiva po standardnem protokolu.
They are ranked under headings of frequency using the following convention:
Pogostnost je navedena v skladu z naslednjim dogovorom:
Silgard is intended for adolescents and adults from 9 years of age onwards.
Cepivo Silgard je namenjeno za mladostnike in odrasle od 9. leta starosti dalje.
The GMTs were somewhat lower than those reported in non-HIV infected subjects of the same age in other studies.
Srednji geometrijski titri so bili nekoliko nižji od tistih, poročanih pri enako starih s HIV neokuženih osebah v drugih študijah.
Since no vaccine is 100% effective and Silgard will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Ker učinkovitost nobenega cepiva ni 100-odstotna in ker cepivo Silgard ne ščiti pred vsemi tipi HPV oziroma pred že obstoječimi okužbami, rutinska presejanja raka materničnega vratu ostajajo kritičnega pomena in jih je treba izvajati v skladu z lokalnimi priporočili.
Human Papillomavirus = HPV
20 mikrogramov humani papilomavirus = HPV
Silgard has not been shown to have a therapeutic effect.
Ni bilo dokazano, da bi cepivo Silgard imelo terapevtski učinek.
Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm.
Bolezni dihal, prsnega koša in mediastinalnega prostora: Zelo redki: bronhospazem
A subset of the study participants from the 2-dose group (n=50) were followed 5-years post-vaccination (Month 60 Postdose 1).
Podskupino sodelujočih v študiji iz skupine z 2 odmerki (n=50) so spremljali 5 let po cepljenju (60. mesec po 1. odmerku).
The most common adverse reactions observed were injection-site adverse reactions (77.1% of vaccinees within 5 days following any vaccination visit) and headache (16.6% of the vaccinees).
Najpogosteje opaženi neželeni učinki so bili neželeni učinki na mestu injiciranja (77,1 % cepljenih v 5 dneh po katerem koli obisku za cepljenje) in glavobol (16,6 % cepljenih).
In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Silgard used hormonal contraceptives during the vaccination period.
V kliničnih študijah je 57,5 % žensk, starih 16 do 26 let, in 31,2 % žensk, starih 24 do 45 let, ki so prejele cepivo Silgard, v obdobju cepljenja uporabljalo hormonske kontraceptive.
Silgard is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Cepivo Silgard je samo za profilaktično uporabo in nima učinka na aktivne okužbe s HPV ali na dokazano klinično bolezen.
The VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Virusu podobni delci ne vsebujejo virusne DNA in ne morejo okužiti celic, se razmnoževati ali povzročiti bolezni.
GMT- Geometric mean titre in mMU/ml (mMU = milli-Merck units)
GST- Geometrijski srednji titer v mMe/ml (mMe = mili-Merck enote)
Silgard cannot cause the diseases it protects against.
Cepivo Silgard ne more povzročiti bolezni, pred katerimi ščiti.
Among 15,706 individuals who received Silgard and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Silgard group and 15 in the placebo group.
Med 15.706 osebami, ki so prejele Silgard, in 13.617 osebami, ki so prejele placebo, je bilo 39 poročil o primeru nespecifičnega artritisa/artropatije: 24 v skupini, ki je prejela Silgard, in 15 v skupini, ki je prejela placebo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z
What Silgard looks like and contents of the pack 1 dose of Silgard suspension for injection contains 0.5 ml.
Izgled cepiva Silgard in vsebina pakiranja 1 odmerek cepiva Silgard suspenzija za injiciranje vsebuje 0,5 ml suspenzije.
95% CI
95-odstotni IZ
Persistence of Immune Response of Silgard
Persistenca imunskega odziva cepiva Silgard
If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice.
Če ste na dogovorjeni termin pozabili ali ob predvidenem času niste mogli priti, se posvetujte z zdravnikom.
Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Čeprav so omedlevice redke, je treba bolnike po cepljenju s cepivom proti HPV opazovati 15 minut.
When Silgard is given as your first dose, the completion of the vaccination course should be done with Silgard, and not with another HPV vaccine.
Če kot prvi odmerek prejmete cepivo Silgard, morate cepljenje dokončati s cepivom Silgard in ne s katerim drugim cepivom proti HPV.
An academic study documenting safety and immunogenicity of Silgard has been performed in 126 HIV infected subjects aged from 7 to 12 years (of which 96 received Silgard).
Akademska študija, v kateri so dokumentirali varnost in imunogenost cepiva Silgard, je bila izvedena pri 126 s HIV okuženih osebah, starih od 7 do 12 let (od katerih jih je 96 prejelo cepivo Silgard).
(95% CI: 67.2, 100) and 100% (95% CI: 55.4, 100), respectively,
(95-odstotni IZ: 67,2; 100) oz. 100 % (95-odstotni IZ: 55,4; 100);
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 4.
Končni rezultati na koncu študije za kombinirano incidenco CIN 2/3 ali AIS v tej populaciji po medianem času spremljanja do 3,7 leta so prikazani v preglednici 4.
Duration of protection of a 2-dose schedule of Silgard has not been established.
Trajanje zaščite po 2-odmerni shemi cepljenja s cepivom Silgard ni bilo ugotovljeno.
adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
adsorbiran na amorfni aluminijev hidroksifosfat sulfat (0,225 mg Al)
There are no safety, immunogenicity or efficacy data to support change during vaccination with Silgard to other HPV vaccines which do not cover the same HPV types.
Podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi med obdobjem cepljenja s cepivom Silgard podpirali zamenjavo z drugimi cepivi proti HPV, ki ne vključujejo enakih tipov HPV, ni na voljo.
At 36 month follow-up, the GMT in girls (2 doses, n = 86) remained non-inferior to the GMT in women (3 doses, n = 86) for all 4 HPV types.
Pri spremljanju v 36. mesecu je GMT pri deklicah (2 odmerka, n = 86) ostal neinferioren od GMT pri ženskah (3 odmerki, n = 86) za vse 4 tipe HPV.
It is recommended that individuals who receive a first dose of Silgard complete the vaccination course
Priporočljivo je, da osebe, ki so prejele prvi odmerek cepiva Silgard, cepljenje dokončajo s cepivom
In only 1 of 11 specimens HPV 16 was found (at Month 32.5) and was not detected in tissue excised during LEEP (Loop Electro-Excision Procedure).
HPV 16 je bil odkrit le v enem od 11 vzorcev (po 32,5 mesecih) in ga niso odkrili pri eksciziji tkiva s postopkom LEEP (“Loop Electro-Excision Procedure”).
The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Mediani čas spremljanja za kombinacijo protokolov (005, 007, 013 in 015) je bil 3,6 leta.
CIN 3 and AIS have been accepted as immediate precursors of invasive cervical
CIN 3 in AIS sta potrjeno neposredni predstopnji invazivne oblike raka materničnega vratu.
The vaccine should not be mixed in the same syringe with any other vaccines and solutions.
Cepiva se v isti injekcijski brizgi ne sme mešati z nobenim drugim cepivom ali raztopino.
See sections 4.4 and 5.1 for important information on the data that support this indication.
Za pomembne podatke, ki podpirajo to indikacijo, glejte poglavji 4.4 in 5.1.
Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Silgard should not receive further doses of Silgard.
Osebe, pri katerih se po prejemu odmerka cepiva Silgard pojavijo simptomi preobčutljivosti, nadaljnjih odmerkov cepiva Silgard ne smejo prejeti.
There was no evidence of protection from disease caused by vaccine HPV types for which women were PCR positive at day 1.
Dokazov o zaščiti pred boleznijo, povzročeno s tipi HPV, ki jih vsebuje cepivo, na katere so bile ženske PCR pozitivne 1. dan, ni bilo.
Overall 12% of the combined study population had an abnormal Pap test suggestive of CIN at Day 1.
V celoti je 12 % vseh v študijo vključenih oseb imelo 1. dan nenormalni Pap test, ki je kazal na CIN.
Efficacy in women (16 to 45 years) with evidence of a prior infection with a vaccine HPV type (seropositive) that was no longer detectable at vaccination onset (PCR negative)
Učinkovitost pri ženskah (16 do 45 let) s potrjeno predhodno okužbo s tipom HPV, ki ga vsebuje cepivo (seropozitivne) in ki se ga ob začetku cepljenja ni dalo več določiti (PCR negativne)
Safety was evaluated in either the entire study population (6 studies) or in a 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 (6 študij), 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).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE
The need for a booster dose has not been established.
Potreba po obnovitvenem odmerku ni bila dokazana.
16- to 26-Year-Old Men
Moški, stari od 16 do 26 let
No minimum antibody level associated with protection has been identified for HPV vaccines.
Minimalne vrednosti protiteles, povezane z zaščito, za cepiva proti HPV niso bile določene.
This population approximates to the general population of men with respect to prevalence of HPV infection or disease at enrolment.
Ta populacija je približek splošne populacije moških glede na prevalenco okužbe s HPV ali bolezni zaradi
This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of Silgard (see section 4.8).
Opažanje temelji na rezultatih iz kliničnega preskušanja, v katerem so sočasno cepili s kombiniranim cepivom dTap-IPV in prvim odmerkom cepiva Silgard (glejte poglavje 4.8).
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by
Med kliničnimi preskušanji peroralni ali drugi kontraceptivi (npr. kontracepcijske tablete) niso zmanjšali zaščite, dosežene s cepivom Silgard.
The clinical significance of this observation is not known.
Klinični pomen tega opažanja ni znan.
Silgard will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (see section 5.1).
Cepivo Silgard ščiti le pred boleznimi, ki jih povzročajo tipi 6, 11, 16 in 18 HPV, ter v določeni meri pred boleznimi, ki jih povzročajo določeni sorodni tipi HPV (glejte poglavje 5.1).
The vaccine is not used to treat HPV related diseases.
Cepivo ni namenjeno zdravljenju bolezni, povezanih s HPV.
As expected for women 24 to 45 years of age (Protocol 019), the observed antibody titres were lower than that seen in women 16 to 26 years.
Kot je bilo pričakovano, so pri ženskah, starih 24 do 45 let (Protokol 019), opazili manjše titre protiteles kot pri ženskah, starih 16 do 26 let.
In the clinical studies, individuals in the Safety Population reported any new medical conditions during the follow-up.
V kliničnih študijah so posamezniki iz populacije, v kateri so podrobneje spremljali varnost cepiva, v času spremljanja poročali o kateri koli spremembi zdravstvenega stanja.
Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Zato je treba previdnostne ukrepe za preprečevanje prenosa spolno prenosljivih bolezni izvajati še naprej.
The clinical relevance of the lower response is unknown.
Klinični pomen manjšega odgovora ni znan.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Tako kot pri vseh cepivih, ki se jih injicira, je treba vedno zagotoviti ustrezno obliko zdravljenja, ki bo v redkih primerih anafilaktične reakcije po cepljenju nemudoma na voljo.
Immune Responses to Silgard at 1 month post dose 3
Imunski odziv na cepivo Silgard 1 mesec po 3. odmerku
The CD4% or plasma HIV RNA was not affected by vaccination.
Cepljenje ni vplivalo na % CD4 ali vrednost HIV RNA v plazmi.
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).
HPV only infects humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP vaccines is mediated by the development of a humoral immune response.
S HPV se okuži le človek, vendar pa študije z analognimi papilomavirusi na živalih kažejo, da je učinkovitost L1 VLP cepiv posledica spodbujanja humoralnega
Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
Zelo redki (pri manj kot 1 od 10.000 cepljenih oseb): Poročali so o težavah z dihanjem (bronhospazem).
What other important information should you or your child know about Silgard
Drugi pomembni podatki o cepivu Silgard, ki jih morate vi ali vaš otrok poznati
Silgard must not be injected intravascularly.
Cepiva Silgard se ne sme injicirati intravaskularno.
In the ITT population the corresponding reduction was 23.9% (95% CI: 15.2, 31.7).
V ITT populaciji je ustrezen delež zmanjšanja znašal 23,9 % (95-odstotni IZ: 15,2; 31,7).
Silgard does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine.
Cepivo Silgard ne učinkuje pri osebah, ki že imajo persistentno okužbo ali bolezen, povezano s katerim koli tipom HPV, ki ga vsebuje cepivo.
The efficacy for all other endpoints is based on protocols 007, 013, and 015.
Učinkovitost proti vsem drugim opazovanim dogodkom temelji na protokolih 007, 013 in 015.
The seroprotection rates (proportion of individuals reaching seroprotective level anti-HBs >10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only).
Odstotek serozaščite (delež oseb, pri katerih je bila dosežena raven serozaščite anti-HBs > 10 mi.e./ml) je ostal nespremenjen (96,5 % pri sočasnem cepljenju in 97,5 % pri cepljenju samo s cepivom proti hepatitisu B).
• Shake well before use to make a suspension.
• Pred uporabo dobro pretresite, da nastane suspenzija.
The vaccine should be administered by intramuscular injection.
Cepivo je treba aplicirati intramuskularno.
In the same study, in girls aged 9-13 years, the immune response after a 2-dose schedule was numerically lower than after a 3-dose schedule (n = 248 at Month 7; n = 82 at Month 36).
V isti študiji pri deklicah, starih 9 do 13 let, je bil imunski odziv po 2-odmerni shemi cepljenja številčno manjši kot po 3-odmerni shemi (n = 248 v 7. mesecu; n = 82 v 36. mesecu).
A clinical trial showed that among girls who received 2 doses of HPV vaccine 6 months apart, antibody responses to the 4 HPV types, one month after the last dose were non-inferior to those among young women who received 3 doses of the vaccine within 6 months.
Klinično preskušanje je pokazalo, da je bil med deklicami, ki so prejele 2 odmerka cepiva proti HPV v razmiku 6 mesecev, odziv protiteles na 4 tipe HPV en mesec po zadnjem odmerku neinferioren od odziva pri mladih ženskah, ki so prejele 3 odmerke cepiva v roku 6 mesecev.
HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
HPV 6 in 11 sta odgovorna za približno 90 % primerov bradavic na spolovilih in 10 % cervikalne intraepitelijske neoplazije nizke stopnje (CIN 1).
• Third injection: 6 months after first injection The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose.
• Tretja injekcija: 6 mesecev po prvi injekciji Drugi odmerek je treba dati vsaj en mesec po prvem odmerku, tretji odmerek pa vsaj 3 mesece po drugem odmerku.
The studies were not powered to assess efficacy against disease caused by individual HPV types.
Študije niso omogočale vrednotenja učinkovitosti proti boleznim zaradi posameznih tipov HPV.
However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Rahlo zvišana telesna temperatura ali okužba zgornjih dihal (na primer prehlad) nista razlog za odložitev cepljenja.
Administration of Silgard at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
Dajanje cepiva Silgard sočasno (vendar na različna mesta, če gre za cepiva, ki se injicirajo) in rekombinantnega cepiva proti hepatitisu B ni vplivalo na imunski odziv na tipe HPV.
There have been reports of administration of higher than recommended doses of Silgard.
Poročali so o dajanju odmerkov cepiva Silgard, ki so bili večji od priporočenih.
Hypersensitivity to the active substances or to any of the excipients.
Preobčutljivost za zdravilne učinkovine ali katero koli pomožno snov.
For any information about this medicinal product, please contact the local representative of the
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika