FrancophonIA/ELRC3.0 huggingface dataset:
English: Cystinosis is a rare, fatal disease, and Cystagon is considered a useful medicine for this disease.
Slovenian: Cistinoza je redka, smrtno nevarna bolezen in zdravilo Cystagon velja za koristno zdravilo zanjo.
English: The amount of cystine in the organs is therefore reduced, and this limits the damage to these organs.
Slovenian: S tem se zmanjša količina cistina v organih, s tem pa tudi njihove okvare.
English: Cystagon is a medicine containing the active substance mercaptamine (also known as cysteamine).
Slovenian: Cystagon je zdravilo, ki vsebuje zdravilno učinkovino merkaptamin (znan tudi kot cisteamin).
English: Cystagon treatment should be started by a doctor who has experience in the treatment of cystinosis.
Slovenian: Zdravljenje z zdravilom Cystagon lahko uvede samo zdravnik, ki ima izkušnje z zdravljenjem cistinoze.
English: For the full list of all side effects reported with Cystagon, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cystagon, glejte navodilo za uporabo.
English: The active substance in Cystagon, mercaptamine, reacts with cystine to form another amino acid, called cysteine, and a compound called a cysteine-cysteamine salt.
Slovenian: Zdravilna učinkovina v zdravilu Cystagon, merkaptamin, reagira s cistinom tako, da tvori drugo aminokislino, imenovano cistein, in snov, imenovano cistein-cisteaminska sol.
English: Why has Cystagon been approved?
Slovenian: Zakaj je bilo zdravilo Cystagon odobreno?
English: Cystagon is used in patients who have nephropathic (kidney) cystinosis.
Slovenian: Zdravilo Cystagon se uporablja za zdravljenje bolnikov, ki imajo nefropatsko (ledvično) cistinozo.
English: How does Cystagon work?
Slovenian: Kako zdravilo Cystagon deluje?
English: How has Cystagon been studied?
Slovenian: Kako je bilo zdravilo Cystagon raziskano?
English: What is Cystagon used for?
Slovenian: Za kaj se zdravilo Cystagon uporablja?
English: What is Cystagon?
Slovenian: Kaj je zdravilo Cystagon?
English: How is Cystagon used?
Slovenian: Kako se zdravilo Cystagon uporablja?
English: A-2304 Orth/Donau Austria
Slovenian: A-2304 Orth/Donau Avstrija
English: 7.5 micrograms**
Slovenian: 7,5 mikrograma**
English: In such cases, the Western Blot method is negative.
Slovenian: V takšnih primerih je bil rezultat na osnovi metode Western Blot negativen.
English: • you have a severe infection with a high temperature (over 38 °C).
Slovenian: • če imate hudo okužbo in zvišano temperaturo (nad 38 °C).
English: 21 Days After
Slovenian: 21 dni po
English: The frequency of these adverse reactions is not known.
Slovenian: Pogostnost teh neželenih učinkov ni znana.
English: Results from Vaccine Effectiveness Study in Jersey
Slovenian: Rezultati študije učinkovitosti cepiva v Jerseyu
English: Dispose of in accordance with local requirements.
Slovenian: Zavrzite v skladu z lokalnimi predpisi.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Slovenian: Kemična in fizikalna stabilnost cepiva med uporabo je dokazana za čas 3 ur pri sobni temperaturi.
English: For further information, see sections 4.8 and 5.1.
Slovenian: Za dodatne informacije glejte poglavji 4.8 in 5.1.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji za zdravilo.
English: • you have problems with your immune system, since your response to the vaccine may then be poor.
Slovenian: • če imate težave z imunskim sistemom, saj je zato lahko vaš odziv na cepivo slab;
English: In the first few weeks after vaccination with Celvapan the results of these tests may not be correct.
Slovenian: V prvih nekaj tednih po cepljenju s cepivom Celvapan izvidi teh preiskav morda ne bodo pravilni.
English: This leaflet was last revised in {month/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec/LLLL}
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Slovenian: Če je tako, potem bo cepljenje prestavljeno na čas, ko se boste počutili bolje.
English: Day 181
Slovenian: 181. dan
English: What Celvapan is and what it is used for 2.
Slovenian: Kaj je cepivo Celvapan in za kaj ga uporabljamo 2.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Slovenian: Zdravniki se zavedajo te možnosti in so v takšnih primerih pripravljeni na postopke nujnega zdravljenja.
English: • Safety and immunogenicity data obtained three weeks after administration of two doses of
Slovenian: • Podatki o varnosti in imunogenosti, dobljenih tri tedne po dajanju dveh odmerkov cepiva
English: Influenza-like illness
Slovenian: Gripi podobna bolezen
English: Anaphylactic reaction*, Hypersensitivity*
Slovenian: Anafilaktična reakcija*, preobčutljivost*
English: This is because the vaccination may not be recommended, or may need to be delayed.
Slovenian: Cepljenje morda ni priporočljivo ali pa ga bo treba prestaviti na poznejši čas.
English: • Side effects observed with flu vaccines given routinely every year The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Slovenian: • Neželeni učinki, ugotovljeni pri uporabi cepiv proti gripi, ki se dajejo rutinsko vsako leto Spodaj navedeni neželeni učinki so se pojavljali v dneh ali tednih po cepljenju s cepivi, ki so jih rutinsko uporabili vsako leto za preprečevanje gripe.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
Slovenian: Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, oziroma če ste bili pred kratkim cepljeni s katerimkoli
English: See section 4.4 for Special warnings and special precautions for use.
Slovenian: Glejte poglavje 4.4 za posebna opozorila in previdnostne ukrepe.
English: • Safety and immunogenicity data in healthy adults, including older people.
Slovenian: • Podatki o varnosti in imunogenosti pri zdravih odraslih, vključno s starostniki.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Slovenian: Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC J07BB01
English: Trivalent seasonal influenza vaccines
Slovenian: Trivalentna cepiva proti sezonski gripi
English: • If a specific notification system has been put in place, how to report adverse
Slovenian: • Način poročanja, če je bil uveljavljen specifičen sistem poročanja
English: 6.5 Nature and contents of the container
Slovenian: 6.5 Vrsta ovojnine in vsebina
English: The vaccine will be injected into a muscle (usually in the upper arm).
Slovenian: Cepivo vam bodo injicirali v mišico (običajno v nadlaket).
English: In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: However, some differences in frequency and type of side effects were observed.
Slovenian: Vendar je bilo nekaj razlik v pogostnosti in vrsti opaženih neželenih učinkov.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Slovenian: Pred cepljenjem natančno preberite navodilo za uporabo, ker vsebuje za vas pomembne podatke!
English: • you are having a blood test to look for evidence of infection with certain viruses.
Slovenian: • če ste naročeni za odvzem krvi, da se potrdi okužba z določenimi virusi.
English: Tell the doctor requesting these tests that you have recently been given Celvapan.
Slovenian: Povejte zdravniku, ki je naročil te preiskave, da ste bili pred kratkim cepljeni s cepivom Celvapan.
English: It should be noted that the adverse reactions may be intensified.
Slovenian: Zavedati se je treba, da so neželeni učinki lahko izrazitejši.
English: ADR frequency is based upon the following scale: Very Common (≥ 1/10); Common (≥ 1/100< 1/10), Uncommon (≥ 1/1,000 - < 1/100), Rare (≥ 1/10,000 - < 1/1,000), Very Rare (< 1/10,000)
Slovenian: Pogostost neželenih učinkov temelji na naslednji lestvici: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000)
English: The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant
Slovenian: Varnost zdravila Celvapan v nosečnosti in obdobju dojenja je bila preverjena pri majhnem številu
English: A protective response may not be elicited in all vaccinees (see section 5.1).
Slovenian: S cepljenjem verjetno ne boste izzvali zaščitnega odziva pri vseh cepljenih osebah (glejte poglavje 5.1).
English: Children aged less than 6 months Vaccination is not currently recommended in this age group.
Slovenian: Otroci, mlajši od 6 mesecev Pri tej starostni skupini cepljenje trenutno ni priporočljivo.
English: Very common: Feeling tired, headache
Slovenian: Zelo pogosti: utrujenost, glavobol
English: The other ingredients are: trometamol, sodium chloride, water for injections, polysorbate 80.
Slovenian: Pomožne snovi so: trometamol, natrijev klorid, voda za injekcije, polisorbat 80.
English: Do not use Celvapan after the expiry date which is stated on the carton.
Slovenian: Cepiva Celvapan ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Slovenian: Cepivo vam bo dal zdravnik ali medicinska sestra v skladu z uradnimi priporočili.
English: Allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock.
Slovenian: alergijske reakcije, vključno z anafilaktičnimi reakcijami, ki so povzročile nevaren padec krvnega tlaka, ki lahko vodi v šok, če ni zdravljen.
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/(H1N1)v vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Slovenian: • Imetnik dovoljenja za promet se bo z državami članicami dogovoril o ukrepih za lažjo identifikacijo in sledljivost cepiva A/(H1N1)v, uporabljenega pri posameznem bolniku, da bi čim bolj zmanjšali napake pri uporabi cepiva ter v pomoč bolnikom in zdravnikom pri poročanju o neželenih učinkih.
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Slovenian: Po cepljenju se lahko pojavijo alergijske reakcije, ki so v redkih primerih povzročile šok.
English: Such alterations in liver function have not been seen to date in human clinical studies.
Slovenian: Takšnih sprememb delovanja jeter doslej še niso opazili v kliničnih študijah pri ljudeh.
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the
Slovenian: • Minimalne podatkovne elemente, ki jih je treba sporočiti v vsakem poročilu, da se olajša vrednotenje in identifikacija uporabljenega cepiva pri posamezni osebi, vključno z imenom cepiva, izdelovalcem in številko serije.
English: What you need to know before you receive Celvapan
Slovenian: Kaj morate vedeti, preden boste cepljeni s cepivom Celvapan
English: Children and adolescents aged 3 to 17 years One dose of 0.5 ml at an elected date.
Slovenian: Otroci in mladostniki od 3 do 17 let En odmerek 0,5 ml na izbran datum.
English: Detailed information on this medicinal product is available on the website of the European Medicines
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA)
English: PSYCHIATRIC DISORDERS
Slovenian: PSIHIATRIČNE MOTNJE
English: Shake before use.
Slovenian: Pred uporabo pretresite.
English: * propagated in Vero cells (continuous cell line of mammalian origin)
Slovenian: * razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora)
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Slovenian: Zato mora zdravnik oceniti koristi in morebitna tveganja cepljenja oseb s trombocitopenijo ali motnjami strjevanja krvi, ki bi povzročile kontraindikacije za intramuskularno injiciranje, razen če morebitni koristni učinki odtehtajo tveganje
English: Name and address of the manufacturers of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (učinkovin)
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by influenza vaccines.
Slovenian: Večina neželenih učinkov je bilo blagih, kratkotrajnih in glede na zvrst podobnih tistim, ki jih povzročijo cepiva proti gripi.
English: However, if this cannot be avoided, the vaccines should be injected into separate limbs.
Slovenian: Če se temu ni mogoče izogniti, je treba cepiva injicirati v različne okončine.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Slovenian: Kot pri vseh cepivih za injiciranje morata biti vedno takoj na voljo ustrezno medicinsko zdravljenje in zdravniški nadzor, če bi po cepljenju prišlo do sicer redke anafilaktične reakcije.
English: Immune response against A/California/07/2009(H1N1)v
Slovenian: Odziv imunskega sistema na sev A/California/07/2009(H1N1)v
English: Prophylaxis of influenza caused by A(H1N1)v 2009 virus (See section 4.4).
Slovenian: Preprečevanje gripe, ki jo povzroča virus A(H1N1)v 2009 (glejte poglavje 4.4).
English: Vaccination is not currently recommended in this age group.
Slovenian: Pri tej starostni skupini cepljenje trenutno ni priporočljivo.
English: In an observational safety study including 3216 subjects aged 6 months to 60 years and older, the nature of adverse events was consistent with those observed in other clinical studies in adults and children.
Slovenian: V opazovalni varnostni študiji, v katero je bilo vključenih 3216 oseb, starih od 6 mesecev do 60 let in več, je bila narava neželenih učinkov skladna z neželenimi učinki, opaženimi v drugih kliničnih študijah pri odraslih in otrocih.
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, HTLV-1.
Slovenian: Po cepljenju proti gripi so poročali o lažno pozitivnih rezultatih seroloških testov na osnovi metode ELISA za določanje protiteles proti virusu humane imunske pomanjkljivosti (HIV-1), virusu hepatitisa C in še posebej virusu HTLV-1.
English: If you have any further questions, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali medicinsko sestro.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Slovenian: Prehodno lažno pozitivni rezultati so lahko posledica nastajanja protiteles IgM kot odziv
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Slovenian: Podatki od nosečnic, cepljenih z različnimi inaktiviranimi sezonskimi cepivi brez adjuvansa, pa niso pokazali malformacij ali toksičnosti cepiva za plod ali novorojenčka.
English: The vaccine is a clear to opalescent, translucent suspension.
Slovenian: Cepivo je bistra do opalescentna, prosojna suspenzija.
English: One dose of 0.5 ml at an elected date.
Slovenian: En odmerek 0,5 ml na izbran datum.
English: A dose (0.5 ml) of the vaccine will be given.
Slovenian: Prejeli boste en odmerek (0,5 ml) cepiva.
English: 2nd Dose
Slovenian: 2. odmerku
English: There are no safety, immunogenicity or efficacy data to support interchangeability of Celvapan with other (H1N1)v vaccines.
Slovenian: Ni podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi potrjevali zamenljivost cepiva Celvapan z drugimi cepivi proti (H1N1)v.
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, unexpected severe adverse reactions, adverse events of special interest
Slovenian: • Neželene učinke, ki imajo pri prijavljanju prednost, tj. smrtne in življenje ogrožajoče neželene učinke, nepričakovane hude neželene učinke, neželene učinke posebnega pomena (AESI).
English: Side effects from clinical studies in adults and older people
Slovenian: Neželeni učinki iz kliničnih študij pri odraslih in starostnikih
English: Animal reproductive toxicology studies do not indicate harmful effects in regard to female fertility, embryo-foetal and pre- and post-natal toxicity.
Slovenian: Študije toksičnosti za razmnoževanje na živalih ne kažejo škodljivih učinkov glede plodnosti samic, razvoja zarodka in ploda ter predporodne in poporodne toksičnosti.
English: Uferstrasse 15
Slovenian: Baxter AG Uferstrasse 15
English: Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Slovenian: Cepivo je treba injicirati intramuskularno, najbolje v deltoidno mišico oziroma v anterolateralni del stegna, odvisno od mišične mase osebe.
English: Preferred MedDRA Term
Slovenian: Prednostni izraz MedDRA
English: • The MAH shall agree with Member States on the provision of a targeted communication to health care professionals which should address the following:
Slovenian: • Imetnik dovoljenja za promet se bo z državami članicami dogovoril o zagotavljanju ciljnega obveščanja za zdravnike, ki mora obravnavati naslednje:
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
English: A minor infection such as a cold should not be problem, but your doctor or nurse should advise whether you could still be vaccinated with Celvapan.
Slovenian: Manjša okužba, kot je na primer prehlad, po navadi ni težava, kljub temu pa poslušajte nasvet zdravnika ali medicinske sestre glede cepljenja s cepivom Celvapan;
English: 12 to 35 months
Slovenian: od 12 do 35 mesecev
English: The dose recommendations take into account available data from clinical studies in healthy subjects who received two doses of Celvapan (H1N1)v.
Slovenian: Priporočila za odmerjanje upoštevajo dostopne podatke potekajočih kliničnih študij pri zdravih preiskovancih, ki so dobili dva odmerka cepiva Celvapan (H1N1)v.
English: In a study with a similar influenza vaccine (containing a H5N1 vaccine strain) that included healthy adults and older people, subjects with a weakened immune system and patients with long-term conditions, the safety profile was similar to that in healthy adults.
Slovenian: V študiji s podobnim cepivom proti gripi (ki je vsebovalo cepilni sev H5N1), v katero so bili vključeni zdravi odrasli in starostniki, preiskovanci z oslabljenim imunskim sistemom in bolniki z dolgotrajnimi boleznimi, je bil varnostni profil podoben kot pri zdravih odraslih.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: Frequency1
Slovenian: Pogostnost1
English: Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
Slovenian: Nevrološke motnje, kot so encefalomielitis, nevritis in Guillain-Barréjev sindrom.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA
English: • Side effects observed during post-marketing surveillance
Slovenian: • Neželeni učinki, opaženi v obdobju trženja cepiva
English: The following adverse reactions were reported at a higher frequency category than in
Slovenian: Naslednji neželeni učinki so bili opaženi z večjo pogostnostjo kot v
English: • The MAH shall agree with Member States on mechanisms allowing patients and health care professionals to have continuous access to updated information regarding Celvapan.
Slovenian: • Imetnik dovoljenja za promet se bo z državami članicami dogovoril o mehanizmih, ki bodo bolnikom in zdravstvenim delavcem omogočili stalen dostop do posodobljenih
English: After first opening the vial is to be used within a maximum of 3 hours.
Slovenian: Po prvem odprtju uporabite vialo v največ 3 urah.
English: • you have a bleeding condition or a bleeding problem or you bruise easily.
Slovenian: • če imate težave s krvavitvami ali zlahka dobite podplutbe.
English: Ask your pharmacist what to do with medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Whole virion influenza vaccine, inactivated, containing antigen of strain*: 7.5 micrograms**
Slovenian: Cepivo proti gripi s celimi inaktiviranimi virusi, ki vsebuje antigen seva*: 7,5 mikrograma**
English: 4.7 Effects on ability to drive and use machines Some undesirable effects mentioned under section 4.8 “Undesirable effects” may affect the ability to
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Na sposobnost vožnje in upravljanja s stroji lahko vplivajo določeni neželeni učinki, ki so navedeni
English: Crude vaccine effectiveness of one dose of pandemic vaccine among children was 100% (95%
Slovenian: Neobdelana učinkovitost cepiva z enim odmerkom pandemskega cepiva pri otrocih je bila 100 % (95-odstotni interval zaupanja: 70-100 %).
English: Pandemic vaccine effectiveness against the medically-attended influenza like illness (ILI) with laboratory-confirmation as A(H1N1)v, was assessed for the vaccination campaign in Jersey 2009/2010 in a case control study (test-negative design).
Slovenian: Učinkovitosti pandemskega cepiva proti gripi podobni bolezni z medicinsko oskrbo in laboratorijsko potrditvijo A(H1N1)v so ugotavljali med cepilno kampanjo 2009/2010 v Jerseyu v obliki študije primerov in kontrol (negativna testna zasnova).
English: There were no reported vaccine failures in either of these paediatric age groups.
Slovenian: V nobeni pediatrični starostni skupini niso ugotovili neuspešnih cepljenj.
English: The safety profile in healthy subjects > 60 years of age, in immune-compromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy subjects.
Slovenian: Varnostni profil pri zdravih osebah, starejših od 60 let, imunsko kompromitiranih osebah in bolnikih s kroničnimi boleznimi je bil podoben kot pri zdravih osebah.
English: * MN titre ≥ 1:40 ** > 4-fold increase in MN titre *** geometric mean increase
Slovenian: * titer MN ≥1:40 ** >4-kratno povečanje titra MN *** geometrična sredina povečanja
English: Immunisation shall be postponed in patients with severe febrile illness or acute infection.
Slovenian: Cepljenje je treba odložiti pri bolnikih, ki imajo hujše obolenje z zvišano telesno temperaturo ali