natgillin/translations-raw huggingface dataset:
The effectiveness of Dany's BienenWohl against varroa mites was investigated in two field studies in European countries with different climates.
Učinkovitost zdravila Dany's BienenWohl proti varoji so proučevali v dveh terenskih študijah v evropskih državah z različnimi podnebji.
Dany's BienenWohl is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose).
Zdravilo Dany's BienenWohl je zelo kislo in je lahko dražilno ali jedko za kožo, oči in sluznice (notranjo površino telesnih votlin, kot so usta in nos).
For more information about using Dany's BienenWohl, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij glede uporabe zdravila Dany's BienenWohl glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
Dany's BienenWohl can only be used on colonies without brood and should be used as part of a wider management programme.
Zdravilo Dany's BienenWohl se lahko uporablja samo v kolonijah brez zalege in ga je treba uporabljati kot del širšega programa zdravljenja.
If possible, the use of Dany's BienenWohl should be alternated with another medicine that kills mites in a different way to reduce the chance of the mites developing resistance.
Če je mogoče, je treba uporabo zdravila Dany's BienenWohl izmenjevati z drugim zdravilom, ki varoje uničuje drugače, da bi se zmanjšala možnost za pojav njihove odpornosti.
This authorisation was based on the authorisation granted to Oxybee in 2018 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Oxybee, ki je bilo izdano leta 2018 (uporaba dokumentacije s soglasjem).
Contact with these areas should be avoided, both directly and by hand-to-mouth or hand-to-eye contact.
Stiku s temi predeli se je treba izogibati, in sicer neposrednemu stiku ter stiku med rokami in usti ali med rokami in očmi.
In the first study treatment with Dany's BienenWohl was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Dany's BienenWohl was compared to a group with no treatment.
V prvi študiji so zdravljenje z zdravilom Dany's BienenWohl primerjali z drugim zdravilom, ki vsebuje oksalno kislino, in z nezdravljeno skupino, v drugi študiji pa so zdravilo Dany's BienenWohl primerjali z nezdravljeno skupino.
Other information about Dany's BienenWohl
Druge informacije o zdravilu Dany's BienenWohl
The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees.
Varoja se hrani s hemolimfo (krvjo) odraslih čebel in z zalego (razvojnimi stopnjami medonosnih čebel), kar povzroči poškodbe in/ali smrt čebel.
How oxalic acid works on mites is not well understood but it is thought that the activity of oxalic acid on mites is due to the acidity of the medicine, which kills the mites on contact.
Učinek oksalne kisline na varoje ni dobro razumljen, vendar se predvideva, da je posledica kislosti zdravila, ki ob stiku uniči varoje.
The company that makes Oxybee has agreed that its scientific data can be used for Dany's BienenWohl (‘informed consent').
Družba, ki proizvaja zdravilo Oxybee, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Dany's BienenWohl („uporaba dokumentacije s soglasjem“).
Dany's BienenWohl (oxalic acid)
Dany's BienenWohl (oksalna kislina)
Dany's BienenWohl is a medicine used to treat varroosis in honey bee colonies.
Dany's BienenWohl je zdravilo, ki se uporablja za zdravljenje varoze v kolonijah medonosnih čebel.
The withdrawal period for honey from honey bees treated with Dany's BienenWohl is ‘zero' days, which means that there is no mandatory waiting time.
Karenca za med medonosnih čebel, zdravljenih z zdravilom Dany's BienenWohl, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
The most common side effect with Dany's BienenWohl (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths.
Najpogostejši neželeni učinek zdravila Dany's BienenWohl (ki lahko prizadene več kot 1 čebeljo kolonijo od 10) je povečano število smrti čebel, kar pa dolgoročno ne vpliva na razvoj kolonij.
Dany's BienenWohl contains the active substance oxalic acid.
Zdravilo Dany's BienenWohl vsebuje učinkovino oksalno kislino.
Why is Dany's BienenWohl authorised in the EU?
Zakaj je zdravilo Dany's BienenWohl odobreno v EU?
Dany's BienenWohl is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Zdravilo Dany's BienenWohl je na voljo v obliki praška in raztopine za pripravo disperzije za čebeljo družino (tekočine za uporabo znotraj panja), njegova izdaja pa je brez recepta.
An overview of Dany's BienenWohl and why it is authorised in the EU
Pregled zdravila Dany's BienenWohl in zakaj je odobreno v EU
What is Dany's BienenWohl and what is it used for?
Kaj je zdravilo Dany's BienenWohl in za kaj se uporablja?
What are the risks associated with Dany's BienenWohl?
Kakšna tveganja so povezana z zdravilom Dany's BienenWohl?
What benefits of Dany's BienenWohl have been shown in studies?
Kakšne koristi je zdravilo Dany's BienenWohl izkazalo v študijah?
How is Dany's BienenWohl used?
Kako se zdravilo Dany's BienenWohl uporablja?
Dany's BienenWohl received a marketing authorisation valid throughout the EU on 14 June 2018.
Zdravilo Dany's BienenWohl je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji,
How does Dany's BienenWohl work?
Kako zdravilo Dany's BienenWohl deluje?
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/14/955/001 Lymphoseek
Številka EMA (Lastniško) ime Jakost
Silgard is a vaccine.
Zdravilo Silgard je cepivo.
Silgard is given according to official recommendations.
Zdravilo Silgard se daje v skladu z uradnimi priporočili.
The full EPAR for Silgard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Silgard je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This document is a summary of the European public assessment report (EPAR) for Silgard.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Silgard.
A risk management plan has been developed to ensure that Silgard is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Silgard je bil pripravljen načrt obvladovanja tveganj.
What measures are being taken to ensure the safe and effective use of
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silgard?
What benefit has Silgard shown during the studies?
Kakšne koristi je zdravilo Silgard izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev
What is the risk associated with Silgard?
Kakšna tveganja so povezana z zdravilom Silgard?
For more information about treatment with Silgard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Silgard preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better
Cepivo vsebuje tudi adjuvans (spojino, ki vsebuje aluminij) za spodbujanje boljšega odziva.
Patients who show signs of an allergy after a dose of Silgard should not receive further doses of the vaccine.
Osebe, ki po odmerku zdravila Silgard kažejo znake alergije, ne smejo prejeti nadaljnjih odmerkov cepiva.
The women were followed up for around three years after the third dose of the vaccine.
Ženske so spremljali približno tri leta po prejemu tretjega
These same three doses can also be used in individuals aged nine to thirteen years.
Enake tri odmerke lahko prejmejo tudi osebe, stare od devet do trinajst let.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silgard, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Silgard in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Silgard is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Cepivo Silgard se uporablja pri dečkih in deklicah, starejših od devet let, za zaščito pred naslednjimi vrstami obolenj, ki jih povzročajo posamezni tipi humanega papilomavirusa (HPV):
The CHMP decided that Silgard's benefits are greater than its risks and recommended that it be given
CHMP je zaključil, da so koristi zdravila Silgard večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Silgard contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Zdravilo Silgard vsebuje prečiščene beljakovine L1 za tipe 6, 11, 16 in 18 humanih papilomavirusov, ki jih proizvajajo z metodo, znano kot tehnologija rekombinantne DNK, pri kateri je v kvasovke vstavljen gen (DNK), kar jim omogoča tvorjenje beljakovin L1.
In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
V študijah so bili najpogostejši neželeni učinki zdravila Silgard (opaženi pri več kot 1 osebi od 10) glavobol in reakcije na mestu injiciranja (rdečina, bolečina in oteklina).
If the second dose is given earlier than six months after the first dose, a third dose should always be given.
Če se drugi odmerek da pred pretekom šestih mesecev po prvem odmerku, je treba vedno dati še tretji odmerek.
There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate
V študiji ni bilo nobenega primera raka zadnjika, a se domneva, da lahko zaščita pred predrakavimi lezijami na zadnjiku pomeni tudi zaščito pred nastankom raka.
The studies also showed that Silgard provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Študije so pokazale tudi, da je zdravilo Silgard zagotovilo zaščito pred lezijami na materničnem vratu, povezanimi z drugimi tipi humanega papilomavirusa (med drugim tudi s tipom 31), ki povzročajo raka.
human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
cepivo proti humanim papilomavirusom [tipom 6, 11, 16, 18]
It is available in vials or prefilled syringes.
Na voljo je v vialah ali napolnjenih injekcijskih
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 na materničnem vratu, povzročene zaradi okužbe z drugima dvema tipoma humanega papilomavirusa (tipoma 6 in 11).
The study testing Silgard given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Študija, v kateri je bilo zdravilo Silgard dano v dveh odmerkih deklicam, starim od devet do trinajst let, je pokazala, da sta bila dva odmerka, ki sta bila dana v razmiku šestih mesecev, prav tako učinkovita kot cepljenje v treh odmerkih: pri vseh osebah je nastalo zadostno število protiteles proti humanemu papilomavirusu v enem mesecu po injiciranju zadnjega odmerka.
Another study in around 800 girls and women compared the effect of two doses of Silgard in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
V drugi študiji, v katero je bilo vključenih okoli 800 deklic in žensk, so primerjali učinek dveh odmerkov zdravila Silgard pri deklicah, starih od devet do trinajst let, in učinek treh odmerkov pri deklicah in mlajših ženskah, starih od 16 do 24 let.
The European Commission granted a marketing authorisation valid throughout the European Union for Silgard on 20 September 2006.
Evropska komisija je dovoljenje za promet z zdravilom Silgard, veljavno po vsej Evropski uniji, izdala
For the full list of all side effects reported with Silgard, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Silgard, glejte navodilo za uporabo.
Three studies of Silgard given as three doses looked at the ability of Silgard to prevent infection with HPV types 6, 11, 16 and 18 and genital lesions caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
V treh študijah so proučevali sposobnost zdravila Silgard, danega v treh odmerkih, za preprečevanje okužbe s tipi 6, 11, 16 in 18 humanega papilomavirusa ter bradavic na spolovilih, ki jih povzročijo ti tipi humanega papilomavirusa, pri skoraj 4 000 ženskah, starih od 24 do 45 let, in nastanek protiteles proti omenjenim tipom virusa pri okoli 1 700 deklicah in dečkih, starih od devet do 15 let.
These virus-like particles are not capable of causing infection.
Ti virusom podobni delci ne
There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Med prvim in drugim odmerkom mora biti najmanj enomesečni presledek, med drugim in tretjim odmerkom pa morajo preteči najmanj trije meseci; osebe morajo vse odmerke prejeti v obdobju enega
For people aged fourteen or above, Silgard is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second..
Zdravilo Silgard se osebam, starejšim od štirinajst let, običajno daje v treh odmerkih, pri čemer drugi odmerek sledi dva meseca po prvem, tretji pa štiri mesece po drugem.
It is recommended that individuals who receive the first dose of Silgard should complete the dosing regimen with Silgard.
Priporočeno je, da osebe, ki prejmejo prvi odmerek, prejmejo vse tri odmerke zdravila Silgard.
Finally, a main study in around 4,000 boys and men from 16 to 26 years of age compared the vaccine against placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
V glavni študiji, v katero je bilo vključenih okoli 4 000 dečkov in moških, starejših od 16 let, so nazadnje cepivo primerjali s placebom, da bi preizkusili učinek cepiva pri preprečevanju nastanka bradavic na spolovilih, predrakavih lezij v zadnjiku in raka zadnjika.
• precancerous lesions (growths) in the cervix, vulva or vagina and anus;
• predrakavimi lezijami (nenormalno rastjo celic) na materničnem vratu, ženskih zunanjih ali
In four main studies of Silgard given as three doses, Silgard was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Zdravilo Silgard, ki so ga dajali v treh odmerkih, so s placebom (cepivom brez zdravilne učinkovine) primerjali v štirih glavnih študijah, v katerih je sodelovalo skoraj 21 000 žensk, starih od 16 do 26 let.
In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Silgard who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
V štirih študijah, v katere je bilo vključenih 21 000 žensk, je bilo dokazano, da so se v skupini žensk, ki predhodno niso bile okužene s tipi 6, 11, 16 ali 18 humanega papilomavirusa, pri eni bolnici od več kot 8 000 žensk, cepljenih z zdravilom Silgard, pojavile predrakave lezije na materničnem vratu, ki bi lahko bile povezane s tipom 16 ali 18 humanega papilomavirusa.
In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Za razliko od tega so med skoraj 8 000 ženskami iz skupine, ki je prejemala placebo, zabeležili 189 primerov lezij na spolovilih.
For people aged nine to thirteen years, Silgard can be given as two doses six months apart.
Zdravilo Silgard se lahko daje osebam, starim od devet do trinajst let, v dveh odmerkih s šestmesečnim razmikom.
In addition, the results confirmed the ability of Silgard to protect against lesions and HPV infection in 24- to 45-year-old women.
Poleg tega so te študije potrdile, da zdravilo Silgard ščiti ženske, stare od 24 do 45 let, pred lezijami in okužbo s humanim papilomavirusom.
HPV types 6 and 11 cause approximately 90% of genital warts.
Tipa 16 in 11 humanega papilomavirusa sta povzročitelja približno 90 % bradavic na
In the three studies on genital lesions 2 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.
V treh študijah, v katerih so proučevali lezije na spolovilih, so se bradavice na spolovilih pojavile pri dveh bolnicah od skoraj 8 000 žensk v skupini, ki je prejemala zdravilo Silgard, primerov predrakavih lezij na zunanjem ali notranjem spolovilu pa ni bilo.
The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18
Glavno merilo učinkovitosti je bil razvoj zaščitnih ravni protiteles proti tipom 6, 11, 16 in 18 humanega papilomavirusa en mesec po injiciranju zadnjega odmerka.
If this applies to you, the vaccination will not be given until you are feeling better.
Če to velja za vas, cepiva ne boste prejeli, dokler se ne boste počutili bolje.
Date of first authorisation: 20 April 2012 Date of latest renewal: 16 February 2017
Datum prve odobritve: 20. april 2012 Datum zadnjega podaljšanja: 16. februar 2017
Make sure you or your child finishes the complete vaccination course.
Zagotovite, da boste vi ali vaš otrok zaključili celotno shemo cepljenja.
These infections are passed easily from person to person and can cause death if not treated.
Te okužbe se zlahka prenašajo s človeka na človeka in lahko povzročijo smrt, če jih ne zdravimo.
Nimenrix should be used in accordance with available official recommendations.
Cepivo Nimenrix je treba uporabljati v skladu z razpoložljivimi uradnimi priporočili.
• you have an infection with a high temperature (over 38°C).
• če imate okužbo z visoko telesno temperaturo (več kot 38 °C).
• septicaemia - an infection of the blood.
• septikemijo - okužbo krvi.
Remove the needle protector, which on occasion can be a little stiff.
Odstranite ščitnik igle, ki je včasih lahko nekoliko tog.
• pain in the arms or legs
• bolečine v rokah in nogah
However, some of the effects mentioned under section 4.8 “Undesirable effects” may affect the ability to drive or use machines.
Toda nekateri učinki, omenjeni v poglavju 4.8 "Neželeni učinki", lahko poslabšajo sposobnost vožnje in upravljanja strojev.
If not used within 8 hours, do not administer the vaccine.
Če se cepivo ne uporabi v 8 urah, ga ne uporabite.
Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution.
Čeprav se ne priporoča, da se cepivo uporabi kasneje, je bila dokazana stabilnost za 8 ur po rekonstituciji pri temperaturi 30 °C.
• This vaccine has been prescribed for you or your child. Do not pass it on to others.
• Cepivo je bilo predpisano vam osebno ali vašemu otroku in ga ne smete dajati drugim.
Adverse reactions reported are listed according to the following frequency categories:
Opisani neželeni učinki so navedeni po naslednjih kategorijah pogostnosti:
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change in the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:
Varnost cepiva Nimenrix, predstavljena v spodnji preglednici, temelji na zbirkah podatkov dveh kliničnih študij, kot sledi:
Local and general adverse reactions
Lokalni in splošni neželeni učinki
These antibodies help protect you against the diseases.
Ta protitelesa telesu pomagajo, da se zaščiti pred boleznimi.
Children (2-17 years) with anatomical or functional asplenia
Otroci (stari od 2 do 17 let) z anatomsko ali funkcijsko asplenijo
It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination.
Dobra klinična praksa je, da se pred cepljenjem preuči zdravstvena anamneza (zlasti glede prejšnjih cepljenj in morebitnih neželenih učinkov) in opravi klinični pregled.
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including other vaccines and medicines obtained without a prescription.
Obvestite zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, vključno z drugimi cepivi in zdravili, ki ste jih prejeli brez recepta.
If you or your child misses a scheduled injection, it is important that you make another appointment.
Če vi ali vaš otrok zamudite predvideno injekcijo, je pomembno, da se dogovorite za drug termin.
Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults.
Neželeni učinki, o katerih so poročali pri preskušancih, starih > 55 let, so bili podobni tistim, ki so jih opazili pri mlajših starostnih skupinah.
• you are allergic to the active substances or any of the other ingredients in this vaccine (listed in section 6).
• če ste alergični na učinkovine ali katerokoli sestavino tega cepiva (navedeno v poglavju 6).
Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.
Podatke o varnosti so ocenili tudi v ločeni študiji, v kateri je enkratni odmerek cepiva Nimenrix prejelo 274 posameznikov, starih 56 let in več.
Pharmacotherapeutic group: vaccines, meningococcal vaccines, ATC code: J07AH08
Farmakoterapevtska skupina: cepiva, cepiva proti meningokokom, oznaka ATC: J07AH08
Study (Age range)
Študija (Starostni razpon)
Timepoint (months)
Časovna točka (meseci)
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov v zvezi z nosečnostjo, embrionalnim/fetalnim razvojem, porodom ali poporodnim razvojem (glejte poglavje 5.3).
• decreased feeling or sensitivity, especially in the skin
• poslabšano zaznavanje, zlasti na koži
Similar responses to groups A and C were observed after one or two doses (see section 5.1).
Proti skupinama A in C so opazili podobne odzive po enem ali dveh odmerkih (glejte poglavje 5.1).
Primary immunisation
Osnovna imunizacija