FrancophonIA/ELRC3.0 huggingface dataset:
English: Macular oedema is swelling in the macula, the central part of the retina (the light-sensing layer at the back of the eye), which can reduce the central part of a person's vision and affect tasks such as reading and driving.
Slovenian: Makularni edem je otekanje makule, osrednjega dela mrežnice (plasti v ozadju očesa, ki zaznava svetlobo), ki lahko zmanjša osrednji del vida posameznika in vpliva na dejavnosti, kot sta branje in vožnja.
English: Patients whose vision is getting worse and is not improved by Ozurdex should also not receive any more implants.
Slovenian: Bolniki, pri katerih se vid poslabša in se z zdravilom Ozurdex ne izboljša, prav tako ne smejo prejeti dodatnih vsadkov.
English: What benefits of Ozurdex have been shown in studies?
Slovenian: Kakšne koristi zdravila Ozurdex so se pokazale v študijah?
English: Ozurdex injection causes only minor trauma to the eyeball and the increase in intraocular pressure is considered to be manageable.
Slovenian: Injiciranje zdravila Ozurdex povzroči manjšo poškodbo zrkla, zvišanje intraokularnega tlaka pa velja za obvladljivo.
English: Ozurdex must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes) and in patients with advanced glaucoma (damage to the nerve of the eye usually caused by high pressure inside the eye) that is not adequately controlled with medicines alone.
Slovenian: Zdravilo Ozurdex se ne sme uporabljati pri bolnikih, ki imajo ali pri katerih obstaja sum, da imajo očesne ali periokularne okužbe (okužbe v očesu ali okoli njega), ter pri bolnikih z napredovalim glavkomom (poškodbo očesnega živca, ki je običajno posledica visokega tlaka v očesu), ki samo z zdravili ni ustrezno nadzorovan.
English: In two main studies involving a total of 1,267 adults Ozurdex was more effective than the sham treatment at improving patients' eyesight.
Slovenian: V dveh glavnih študijah, ki sta skupaj vključevali 1 267 odraslih, je bilo zdravilo Ozurdex učinkovitejše od navideznega zdravljenja pri izboljševanju vida bolnikov.
English: The most common side effects with Ozurdex (which may affect more than 1 in 10 people) are increased intraocular pressure (the pressure inside the eye), conjunctival haemorrhage (bleeding from the membrane over the white of the eye) and cataract (clouding of the lens - in patients with uveitis and with diabetes).
Slovenian: Najpogostejši neželeni učinki zdravila Ozurdex (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so zvišan intraokularni tlak (tlak znotraj očesa), krvavitev iz veznice (krvavitev iz membrane, ki prekriva beločnico) in katarakta (zameglitev leče - pri bolnikih z uveitisom in sladkorno boleznijo).
English: This ensures that adequate amounts of dexamethasone reach the area inside the eye where the inflammation in macular oedema and uveitis occurs.
Slovenian: To zagotovi, da zadostna količina deksametazona doseže predel v očesu, v katerem je prišlo do makularnega edema in uveitisa.
English: However, in those with an artificial lens in the affected eye or who previously have not responded to or are unsuitable for other non-corticosteroid treatments, the benefits of Ozurdex were considered to outweigh the risks.
Slovenian: Vendar pa je bilo ocenjeno, da pri bolnikih z umetno lečo v prizadetem očesu ali pri tistih, ki se predhodno niso odzvali na druga kortikosteroidna zdravila oziroma ta niso primerna zanje, koristi zdravila Ozurdex odtehtajo njegova tveganja.
English: What is Ozurdex and what is it used for?
Slovenian: Kaj je zdravilo Ozurdex in za kaj se uporablja?
English: Because dexamethasone is a well-known anti-inflammatory medicine, the company presented studies from the published literature where Ozurdex was compared with a ‘sham' treatment (where an applicator was pressed against their eye but nothing was actually injected).
Slovenian: Ker je deksametazon dobro znano protivnetno zdravilo, je podjetje predložilo študije iz objavljene literature, v katerih so zdravilo Ozurdex primerjali z „navideznim“ zdravljenjem (pri katerem se aplikator pritisne ob oko, vendar do samega injiciranja ne pride).
English: Macular oedema related to diabetes
Slovenian: Makularni edem, povezan s sladkorno boleznijo
English: What are the risks associated with Ozurdex?
Slovenian: Kakšna tveganja so povezana z zdravilom Ozurdex?
English: It is used to treat adults with impaired vision due to macular oedema associated with:
Slovenian: Uporablja se za zdravljenje odraslih z okvaro vida zaradi makularnega edema, povezanega z/s:
English: Patients whose vision gets better and stays better should not receive any more implants.
Slovenian: Bolniki, pri katerih se vid izboljša in se izboljšano stanje tudi ohrani, ne smejo prejeti dodatnih vsadkov.
English: Ozurdex was more effective than sham treatment at reducing inflammation in patients with uveitis measured by an improvement in patients' vitreous haze score which gives an indication of inflammation, with zero indicating no inflammation.
Slovenian: Zdravilo Ozurdex je bilo učinkovitejše od navideznega zdravljenja pri zmanjševanju vnetja pri bolnikih z uveitisom, kar so merili z izboljšanjem stopnje motnosti steklovine, ki je kazalnik vnetja, pri čemer rezultat nič pomeni odsotnost vnetja.
English: In one main study involving 229 adults with uveitis, 8 weeks after injection, around 47% of patients treated with 700 micrograms of Ozurdex achieved a vitreous haze score of zero, compared with 36% of patients treated with 350 micrograms of Ozurdex and 12% of patients who received the sham treatment.
Slovenian: V eni glavni študiji, ki je vključevala 229 odraslih z uveitisom, je osem tednov po injiciranju približno 47 % bolnikov, zdravljenih s 700 miligrami zdravila Ozurdex, doseglo ničto stopnjo motnosti steklovine, v primerjavi s 36 % bolnikov, zdravljenih s 350 mikrogrami zdravila Ozurdex, in 12 % bolnikov, ki so prejeli navidezno zdravljenje.
English: Two main studies involving 1,048 patients compared the effects of a 700 microgram or a 350 microgram implant of Ozurdex.
Slovenian: V dveh glavnih študijah, ki sta vključevali 1 048 bolnikov, so primerjali učinek 700-mikrogramskega in 350-mikrogramskega vsadka zdravila Ozurdex.
English: In the first study, around 23% of the patients receiving Ozurdex had increased BCVA of at least 15 letters after 180 days compared with 17% of the patients receiving the sham treatment.
Slovenian: V prvi študiji se je pri približno 23 % bolnikov, ki so prejeli zdravilo Ozurdex, po 180 dneh BCVA izboljšala za vsaj 15 črk, v primerjavi s 17 % bolnikov, ki so prejeli navidezno zdravljenje.
English: The European Medicines Agency decided that Ozurdex's benefits are greater than its risks in patients with uveitis or macular oedema related to blocked veins, and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so pri bolnikih z uveitisom ali makularnim edemom, povezanim z zaporo ven, koristi zdravila Ozurdex večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Ozurdex is an implant that is injected into the eye.
Slovenian: Zdravilo Ozurdex je vsadek, ki se injicira v oko.
English: Ozurdex can only be obtained with a prescription and must be given by an ophthalmologist (eye specialist) who has experience in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Slovenian: Predpisovanje in izdaja zdravila Ozurdex je le na recept, injicirati pa ga mora ustrezno usposobljeni oftalmolog (specialist za oči), ki ima izkušnje z dajanjem intravitrealnih injekcij (injiciranjem v steklovino, tj. želatini podobno tekočino v očesu).
English: In the second study, the figures were around 22% for Ozurdex after 90 days and 12% for the sham treatment.
Slovenian: V drugi študiji je bilo takih bolnikov po 90 dneh približno 22 % pri zdravilu Ozurdex in 12 % pri navideznem zdravljenju.
English: In patients in whom other types of treatment had not worked or were unsuitable, there was an average improvement in BCVA over both studies of 3.2 letters after Ozurdex 700 micrograms, compared with 1.5 letters after sham treatment.
Slovenian: Pri bolnikih, pri katerih nobeno drugo zdravljenje ni učinkovalo ali ni bilo primerno, je bilo povprečno izboljšanja BCVA v obeh študijah 3,2 črke po prejemu zdravila Ozurdex 700 mikrogramov in 1,5 črke po navideznem zdravljenju.
English: How does Ozurdex work?
Slovenian: Kako zdravilo Ozurdex deluje?
English: In patients whose lens had already been surgically replaced, there was an average improvement in BCVA over both studies of 6.5 letters after Ozurdex 700 micrograms, compared with 1.7 letters after sham treatment.
Slovenian: Pri bolnikih, pri katerih so lečo že kirurško zamenjali, je bilo povprečno izboljšanje BCVA v obeh študijah 6,5 črke po prejemu zdravila Ozurdex 700 mikrogramov in 1,7 črke po navideznem zdravljenju.
English: Patients receive one Ozurdex implant at a time, injected directly into the vitreous humour.
Slovenian: Bolniki prejmejo en vsadek zdravila Ozurdex naenkrat, injicira pa se neposredno v steklovino.
English: How is Ozurdex used?
Slovenian: Kako se zdravilo Ozurdex uporablja?
English: For the full list of restrictions with Ozurdex, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Ozurdex glejte navodilo za uporabo.
English: Macular oedema related to blocked veins of the retina
Slovenian: Makularni edem, povezan z zaporo ven v mrežnici
English: Ozurdex implants are injected directly into the vitreous humour of the eye.
Slovenian: Vsadki zdravila Ozurdex se injicirajo neposredno v očesno steklovino.
English: Ozurdex is also used to treat adults with non-infectious uveitis at the back of the eye. Uveitis is inflammation of the uvea, the middle layer of the eye.
Slovenian: Zdravilo Ozurdex se uporablja tudi za zdravljenje odraslih z nenalezljivim uveitisom v očesnem ozadju.
English: For the full list of side effects of Ozurdex, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ozurdex, glejte navodilo za uporabo.
English: Clopidogrel BMS 75 mg
Slovenian: Pretisni omot (PVC/PVDC/alu) 50x1
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Jakost Farmacevtska oblika
English: Some of these reactions have been severe.
Slovenian: Nekatere takšne reakcije so bile hude.
English: Long-term effectiveness studies
Slovenian: Dolgoročne študije učinkovitosti
English: Number of cases*
Slovenian: Število primerov*
English: The duration of protection is not yet known.
Slovenian: Trajanje zaščite še ni znano.
English: Date of first authorisation: 10 June 2015 Date of latest renewal: {DD month YYYY}
Slovenian: Datum prve odobritve: 10. junij 2015 Datum zadnjega podaljšanja: {DD. mesec LLLL}
English: All three doses should be given within a 1-year period.
Slovenian: Vse tri odmerke cepiva je treba dati v obdobju 1 leta.
English: Allergic reactions have been reported.
Slovenian: Poročali so o alergijskih reakcijah.
English: CI=Confidence Interval.
Slovenian: IZ = interval zaupanja
English: Paediatric population (children <9 years of age)
Slovenian: Pediatrična populacija (otroci, stari < 9 let)
English: Few individuals (0.1%) discontinued due to adverse experiences.
Slovenian: Le malo oseb (0,1 %) je uporabo prekinilo zaradi neželenih učinkov.
English: However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
Slovenian: Vendar pa lahko nekateri učinki, navedeni v poglavju 4.8 "Neželeni učinki", prehodno poslabšajo sposobnost vožnje in upravljanja strojev.
English: Please speak to your doctor for more information.
Slovenian: Za več informacij se posvetujte z zdravnikom.
English: Seroconversion to all four antigens occurred in more than 96% of the subjects.
Slovenian: Serokonverzija za vse štiri antigene se je pojavila pri več kot 96 % oseb.
English: • has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia;
Slovenian: • motnjo strjevanja krvi (bolezen, pri kateri krvavite več, kot je normalno), na primer hemofilijo,
English: If you are a woman, you should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Slovenian: Če ste ženska, morate še naprej upoštevati zdravnikova navodila o brisih materničnega vratu/testih Pap in preventivnih ter zaščitnih ukrepih.
English: Stability data indicate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 25°C or from 0°C to 2°C.
Slovenian: Podatki o stabilnosti kažejo, da so komponente cepiva stabilne 72 ur pri shranjevanju pri temperaturi od 8 °C do 25 °C ali od 0 °C do 2 °C.
English: {MM/YYYY}
Slovenian: {MM. LLLL}
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega cepiva.
English: qHPV vaccine was also known as Silgard in some countries.
Slovenian: Cepivo qHPV je bilo v nekaterih državah znano tudi pod imenom Silgard.
English: The vaccine has not been shown to have a therapeutic effect.
Slovenian: Ni bilo dokazano, da bi to cepivo imelo terapevtski učinek.
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: • Genital warts (Condyloma acuminata) caused by specific HPV types.
Slovenian: • genitalnim bradavicam (Condyloma acuminata), ki jih povzročajo specifični tipi HPV.
English: It is important that procedures are in place to avoid injury from fainting.
Slovenian: Pomembno je, da so vzpostavljeni ukrepi za preprečitev poškodb zaradi omedlevice.
English: It is important that you follow your doctor or nurse's instructions regarding return visits for the followup doses.
Slovenian: Pomembno je, da navodila zdravnika ali medicinske sestre o ponovnih obiskih zaradi naslednjih odmerkov cepiva natančno upoštevate.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Slovenian: Za navodila o ravnanju s cepivom pred uporabo glejte poglavje 6.6.
English: The marketing authorisation holder shall submit the first periodic safety update report for this medicinal product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Very common Headache Common
Slovenian: Zelo pogosti glavobol
English: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination.
Slovenian: Pri odločitvi za cepljenje posameznika je treba upoštevati tveganje za predhodno izpostavitev HPV in potencialno korist cepljenja.
English: Evidence of anamnestic (Immune Memory) response
Slovenian: Dokaz anamnestičnega odziva (imunskega spomina)
English: Talk to your doctor or nurse if you or your child:
Slovenian: Posvetujte se z zdravnikom ali medicinsko sestro, če imate vi ali vaš otrok:
English: Gardasil 9 should be administered as soon as possible after being removed from the refrigerator.
Slovenian: Cepivo Gardasil 9 je treba uporabiti čim prej po tem, ko ga vzamete iz hladilnika.
English: The VLPs cannot infect cells, reproduce or cause disease.
Slovenian: VLP ne morejo okužiti celic, se razmnoževati ali povzročiti bolezni.
English: A. Summary of the safety profile
Slovenian: A. Povzetek varnostnega profila cepiva
English: Vaccination should be postponed until completion of pregnancy (see section 5.1).
Slovenian: Cepljenje je treba odložiti do konca nosečnosti (glejte poglavje 5.1).
English: If you are pregnant, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to cepivo.
English: The minimum anti-HPV titre that confers protective efficacy has not been determined.
Slovenian: Najnižji titer anti-HPV, ki prinaša zaščitno učinkovitost, ni ugotovljen.
English: A repeat dose toxicity study in rats, which included an evaluation of single-dose toxicity and local tolerance, revealed no special hazards to humans.
Slovenian: Študija toksičnosti ponavljajočih se odmerkov pri podganah, ki je vključevala ovrednotenje toksičnosti enkratnega odmerka in lokalnega prenašanja, ni pokazala posebnih tveganj za človeka.
English: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Slovenian: Neželeni učinki, za katere obstaja vsaj možnost, da so povezani s cepljenjem, so razvrščeni po pogostnosti.
English: ASC-US=Atypical squamous cells of undetermined significance.
Slovenian: ASC-US = atipične skvamozne celice neugotovljene pomembnosti (atypical squamous cells of undetermined significance)
English: The efficacy of L1 VLP vaccines is thought to be mediated by the development of a humoral immune response.
Slovenian: Domnevno je učinkovitost L1 VLP cepiv posledica razvoja humoralnega imunskega odziva.
English: %Efficacy** (95% CI)
Slovenian: učinkovitosti** (95 % IZ)
English: POPULATION
Slovenian: POPULACIJA
English: The full recommended dose of the vaccine should be used.
Slovenian: Uporabiti morate celoten priporočeni odmerek cepiva.
English: • is allergic to any of the active substances or any of the other ingredients of this vaccine (listed under “other ingredients”, in section 6).
Slovenian: • če ste vi ali vaš otrok alergični na katero koli učinkovino ali katero koli sestavino tega cepiva (navedeno pod "Druge sestavine cepiva" v poglavju 6).
English: Therefore, vaccinees should be observed for approximately 15 minutes after vaccination.
Slovenian: Zato je treba cepljene osebe po cepljenju opazovati približno 15 minut.
English: Pharmacotherapeutic group: Vaccines, Papillomavirus vaccines, ATC code: J07BM03
Slovenian: Farmakoterapevtska skupina: cepiva, cepiva proti virusom papiloma, oznaka ATC: J07BM03
English: Adjuvants are included to improve the immune response of vaccines.
Slovenian: Adjuvanse dodajamo za izboljšanje imunskega odziva na cepiva.
English: • suffer from an illness with high fever.
Slovenian: • bolezen z močno zvišano telesno temperaturo.
English: qHPV Vaccine N=7105
Slovenian: qHPV cepivo N = 7.105
English: Efficacy and/or immunogenicity of Gardasil 9 were assessed in ten clinical studies.
Slovenian: Učinkovitost in/ali imunogenost cepiva Gardasil 9 so ovrednotili v desetih kliničnih študijah.
English: The scales for these assays are unique to each HPV type; thus, comparisons across types and to other assays are not appropriate.
Slovenian: Merske lestvice za te preizkuse so edinstvene za vsak tip HPV, zato primerjave med tipi in primerjave z drugimi preizkusi niso primerne.
English: The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
Slovenian: Cepivo je namenjeno samo za profilaktično uporabo in nima učinka na aktivne okužbe s HPV ali na potrjeno klinično bolezen.
English: The differences observed were < 10% and in the majority of subjects, the adverse events were reported as mild to moderate in intensity (see section 4.5).
Slovenian: Razlike so bile < 10 %, v večini primerov pa je šlo za neželene učinke blage do zmerne intenzivnosti (glejte poglavje 4.5).
English: The vaccine will only protect against diseases that are caused by HPV types targeted by the vaccine (see section 5.1).
Slovenian: Cepivo ščiti le pred boleznimi, ki jih povzročajo tipi HPV, proti katerim je cepivo namenjeno (glejte poglavje 5.1).
English: 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.
Slovenian: Ker gre za učinke, poročane prostovoljno in iz populacije, katere velikost je negotova, ni vedno mogoče zanesljivo oceniti njihove pogostnosti ali za vse učinke ugotoviti vzročne povezanosti z izpostavljenostjo cepivu.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Slovenian: To cepivo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar pomeni, da je praktično "brez natrija".
English: qHPV Vaccine
Slovenian: qHPV cepivo
English: Gardasil 9 is intended to prevent these diseases.
Slovenian: Cepivo Gardasil 9 je namenjeno preprečevanju teh bolezni.
English: Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you or your child. - Keep this leaflet.
Slovenian: Pred cepljenjem natančno preberite navodilo, ker vsebuje za vas ali vašega otroka pomembne podatke!
English: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Slovenian: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Nizozemska
English: *Adverse reactions included in this table are from 7 clinical trials (PN 001, 002, 003, 005, 006, 007 and 009, N=15,776 individuals) (see section 5.1 for description of the clinical trials).
Slovenian: *Neželeni učinki, vključeni v tej preglednici, so iz 7 kliničnih preizkušanj (PN 001, 002, 003, 005, 006, 007 in 009, N=15.776 oseb) (glejte poglavje 5.1 za opis kliničnih preskušanj).
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery.
Slovenian: Spremlja jo lahko več nevroloških znakov, kot so prehodne motnje vida, parestezije ali tonično-klonični gibi udov med okrevanjem.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Slovenian: Tako kot pri vseh cepivih, ki se jih injicira, je treba vedno zagotoviti, da bosta v primeru redke anafilaktične reakcije po aplikaciji cepiva na voljo ustrezno zdravljenje in nadzor.
English: Immunogenicity in HIV infected subjects
Slovenian: Imunogenost pri osebah, okuženih s HIV
English: The vaccine should not be mixed in the same syringe with any other vaccines and solution.
Slovenian: Cepiva se v isti injekcijski brizgi ne sme mešati z nobenim drugim cepivom ali raztopino.
English: In the long-term extensions of clinical studies Protocols 001 and 002, effectiveness was observed in the PPE population.
Slovenian: V dolgotrajnih podaljšanjih kliničnih študij Protokolov 001 in 002 so opazili učinkovitost v populaciji PPE.
English: Hormonal contraceptives (for example the pill) did not reduce the protection obtained by Gardasil 9.
Slovenian: Hormonski kontraceptivi (na primer kontracepcijske tablete) niso zmanjšali zaščite, dosežene s cepivom Gardasil 9.
English: Clinical studies evaluating the efficacy of Gardasil 9 against placebo were not acceptable because HPV vaccination is recommended and implemented in many countries for protection against HPV infection and disease.
Slovenian: Klinične študije za oceno učinkovitosti cepiva Gardasil 9 v primerjavi s placebom niso bile sprejemljive, ker cepljenje proti HPV v številnih državah priporočajo in izvajajo za zaščito proti okužbi s HPV in bolezni zaradi HPV.
English: The safety profile was similar to non-HIV infected subjects in other studies.
Slovenian: Varnostne značilnosti so bile podobne kot pri s HIV neokuženih osebah iz drugih študij.