FrancophonIA/ELRC3.0 huggingface dataset:
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
Slovenian: Spremembe krvnega tlaka pri normotenzivnih bolnikih so klinično nepomembne, zato se lahko zdravilo Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena uporablja pri hipertenzivnih in tudi pri normotenzivnih bolnikih z benigno hiperplazijo prostate (BPH - benign prostatic hyperplasia).
English: Take special care with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Slovenian: Bodite posebno pozorni pri jemanju zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena:
English: Do not take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Slovenian: Ne jemljite zdravila Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena:
English: How to take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I] 4.
Slovenian: NAVODILO ZA UPORABO Doxazosin Winthrop 4 mg tablete s podaljšanim sproščanjem in povezana imena [glejte Dodatek I] (doksazosin)
English: 8 MARKETING AUTHORISATION NUMBER
Slovenian: 8 ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica]
English: The procedure started on 18 October 2007.
Slovenian: Postopek se je začel dne 18. oktobra 2007.
English: Ref. EMEA/CHMP/541853/2008
Slovenian: EMEA/CHMP/541636/2008
English: London, 6 October 2008 Doc.
Slovenian: London, 6. oktober 2008 Sklic na dok.
English: A Decision was issued by the European Commission on 6 October 2008.
Slovenian: Evropska komisija je odločbo izdala dne 6. oktobra 2008.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008.
Slovenian: Imetnik dovoljenja za promet z zdravilom je dne 28.januarja 2008 priskrbel dodatne informacije.
English: Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ml oral drops, 1 mg/ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Slovenian: Zyrtec in z njim povezana imena, 10-miligramske filmsko obložene tablete, 10 mg/ml peroralne kapljice, 1 mg/ml peroralna raztopina, je protialergijsko zdravilo, namenjeno za lajšanje nosnih in očesnih simptomov sezonskega in celoletnega alergijskega rinitisa ter lajšanje simptomov kronične idiopatske utikarije (bolezni kože, ki jo povzroča alergija in katere simptomi vključujejo srbenje in izpuščaje).
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Slovenian: Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila (SPC) Zyrtec in z njim povezana imena, ki so bili odobreni v vseh državah članicah EU, zlasti v zvezi z indikacijami, odmerjanjem, kontraindikacijami in posebnimi opozorili.
English: On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Slovenian: Komisija je dne 9. oktobra 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, da bi uskladila na nacionalni ravni odobrene povzetke glavnih značilnosti zdravila (SPC), označevanja in navodila za uporabo zdravila Zyrtec in z njim povezana imena.
English: During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Slovenian: Med svojim zasedanjem maja 2008 je CHMP na osnovi vseh predloženih podatkov in znanstvene razprave v Odboru menil, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanj in navodil za uporabo sprejemljiv in da bi bilo treba navedene dokumente dopolniti.
English: The CHMP gave a positive opinion on 30 May 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Zyrtec and associated names.
Slovenian: CHMP je dne 30. maja 2008 izdal pozitivno mnenje, s katerim priporoča uskladitev povzetkov glavnih značilnosti zdravila, označevanj in navodil za uporabo za zdravilo Zyrtec in z njim povezana imena.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names International Non-Proprietary Name (INN): cetirizine
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA zdravilo Zyrtec in z njim povezana imena
English: Let stand for 20 minutes.
Slovenian: Pustite stati 20 minut.
English: Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
Slovenian: Datum pridobitve dovoljenja za promet: 13. avgust 1999 Datum zadnjega podaljšanja dovoljenja za promet: 27. julij 2009
English: Subjects were followed for safety and efficacy for 150 days.
Slovenian: Bolnike so spremljali glede varnosti in učinkovitosti 150 dni.
English: However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Slovenian: Stabilnost po pripravi je sicer dokazana za 3 ure pri 20 - 24°C.
English: On this basis, the absolute risk reduction is 5.8% which means the number needed to treat is 17 to prevent one hospitalisation.
Slovenian: Glede na to je absolutno zmanjšanje tveganja 5,8%, kar pomeni, da je število potrebnih zdravljenj za preprečitev ene hospitalizacije 17.
English: In vitro studies of antiviral activity
Slovenian: In vitro študije protivirusne aktivnosti
English: unusual bruising or groups of tiny red spots on the skin.
Slovenian: • nenavadne modrice ali skupine majhnih rdečih pik na koži.
English: These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg.
Slovenian: Ti odmerki so bili 20,25 mg/kg, 21,1 mg/kg in 22,27 mg/kg.
English: AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, USA
Slovenian: AstraZeneca Pharmaceuticals Limited Partnership (AZPLP) 660 MedImmune Court / 633 Research Court, Frederick, Maryland, ZDA
English: In some cases, fatalities have been reported (see section 4.8).
Slovenian: V nekaj primerih so poročali o smrtnih primerih (glejte poglavje 4.8).
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki za ‘EXP'.
English: Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.
Slovenian: Pred uporabo tega zdravila pri vašem otroku natančno preberite navodilo, ker vsebuje za vas in vašega otroka pomembne podatke.
English: Where possible, the first dose should be administered prior to commencement of the RSV season.
Slovenian: Prvi odmerek je treba po možnosti uporabiti pred začetkom sezone RSV.
English: The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States.
Slovenian: Večina testiranih kliničnih RSV izolatov (n=96) je bilo zbranih od osebkov v Združenih državah Amerike.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo bolnika nadzorovati zaradi kakršnih koli znakov in simptomov neželenih reakcij ali učinkov in nemudoma uvesti ustrezno simptomatsko zdravljenje.
English: In clinical studies, three children received an overdose of more than 15 mg/kg.
Slovenian: V kliničnih raziskavah so trije otroci dobili prevelike odmerke, večje od 15 mg/kg.
English: In the first study, all 153 premature infants received both formulations in different sequences.
Slovenian: V prvi študiji je vseh 153 nedonošenčkov prejelo obe obliki v različnih zaporedjih.
English: For example, for a baby with a body weight of 3 kg, the calculation becomes:
Slovenian: Na primer za dojenčka s telesno maso 3 kg velja naslednji izračun:
English: 04011 Campoverde di Aprilia (LT) Italy
Slovenian: 04011 Campoverde di Aprilia (LT) Italija
English: Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)
Slovenian: Anafilaksija, anafilaktični šok (v nekaterih primerih so poročali o smrtih)
English: Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Slovenian: Raztopina palivizumaba mora stati na sobni temperaturi vsaj 20 minut, dokler se ne zbistri.
English: Store in a refrigerator (2ºC to 8ºC).
Slovenian: Shranjujte v hladilniku (2°C - 8°C).
English: Groups were equally balanced between cyanotic and acyanotic patients.
Slovenian: Skupini sta bila uravnoteženi glede cianotičnih in necianotičnih bolnikov.
English: This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
Slovenian: To humanizirano monoklonsko protitelo je sestavljeno iz človeških (95%) in murinih (5%) protitelesnih zaporedij.
English: One hundred and three (103) children received monthly palivizumab injections for the first time, and 119 children received palivizumab for two consecutive seasons.
Slovenian: Sto trije (103) otroci so mesečne injekcije palivizumaba dobili prvič, 119 otrok pa je dobivalo palivizumab dve sezoni zapored.
English: If your child misses an injection, you should contact your doctor as soon as possible.
Slovenian: Če otrok zamudi injekcijo, se čim prej obrnite na zdravnika.
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Če želite poslušati ali prejeti kopijo teh Navodil za uporabo v <Braillovi pisavi>, <v večjem tisku> ali <zvočni obliki>, se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Of this group 1,250 enrolled infants had 6 injections, 183 infants had 7 injections, and 27 infants had either 8 or 9 injections.
Slovenian: V tej skupini je 1.250 vključenih dojenčkov dobilo 6 injekcij, 183 dojenčkov 7 injekcij in 27 dojenčkov 8 ali 9 injekcij.
English: Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution.
Slovenian: Vstavite iglo v vialo in v brizgo odvzemite ustrezen volumen raztopine.
English: No medical consequences were identified in these instances.
Slovenian: V nobenem od teh primerov niso ugotovili zdravstvenih posledic.
English: Patients with hemodynamically significant congenital heart disease were excluded from enrollment in this study and were studied in a separate study.
Slovenian: Bolniki s hemodinamično pomembno prirojeno boleznijo srca so bili izključeni iz postopka vključevanja v to študijo in so jih proučevali v ločeni študiji.
English: The neutralization titre (50% effective concentration [EC50]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells.
Slovenian: Nevtralizacijski titer (50 odstotno učinkovita koncentracija [EC50]) je izražen kot koncentracija protiteles, ki je potrebna za zmanjšanje detekcije RSV protiteles za 50% v primerjavi z nezdravljenimi, z virusom okuženimi celicami.
English: Data on fertility, pregnancy and lactation are not available.
Slovenian: Podatkov o vplivu na plodnost, nosečnost in dojenje ni na voljo.
English: • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Slovenian: • pri otrocih, mlajših od 2 let, ki imajo hemodinamično pomembno prirojeno bolezen srca.
English: The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1).
Slovenian: Večina izkušenj s palivizumabom, tudi tistih v ključnih kliničnih preskušanjih III. faze, je bila pridobljena s 5 injekcijami v eni sezoni (glejte poglavje 5.1).
English: Undesirable effects in clinical studies* and post-marketing reports in paediatric patients MedDRA system organ class
Slovenian: Neželeni učinki v kliničnih študijah* in poročila iz obdobja trženja zdravila pri pediatričnih bolnikih
English: For your child's best protection, it is necessary to take the doctor's advice about when to return for additional doses of Synagis.
Slovenian: Za najboljšo zaščito vašega otroka upoštevajte zdravnikova navodila o tem, kdaj je treba priti po dodatne odmerke zdravila Synagis.
English: After reconstitution, the product should be used immediately.
Slovenian: Po rekonstituciji morate zdravilo uporabiti takoj.
English: If your child is to have a heart operation (cardiac bypass surgery), he or she may be given an extra dose of Synagis after the operation.
Slovenian: Če bo vaš otrok imel operacijo na srcu (operacija na srcu z zunajtelesnim obtokom), bo po operaciji morda dobil dodaten odmerek zdravila Synagis.
English: Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation.
Slovenian: Raztopina palivizumaba ne vsebuje konzervansa in jo je treba uporabiti v 3 urah po pripravi.
English: The adverse reactions identified via post-marketing surveillance 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 palivizumab exposure.
Slovenian: Neželeni učinki iz obdobja spremljanja zdravila na trgu so bili poročani prostovoljno iz neznano velike populacije; ni vedno možno zanesljivo izračunati njihove pogostnosti ali vzpostaviti vzročne povezave z izpostavljenostjo palivizumabu.
English: No formal interactions studies with other medicinal products were conducted.
Slovenian: Formalnih raziskav medsebojnega delovanja z drugimi zdravili ni bilo.
English: For instructions on special handling requirements, see section 6.6.
Slovenian: Za navodila glede posebnih zahtev za ravnanje z zdravilom, glejte poglavje 6.6.
English: After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.
Slovenian: Ko ste dodali vodo, vialo rahlo nagnite in jo obzirno vrtite 30 sekund.
English: Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.
Slovenian: Nemudoma pokličite zdravnika ali poiščite zdravniško pomoč, če ima vaš otrok katerega od zgoraj navedenih resnih neželenih učinkov po prejemu katerega koli odmerka zdravila Synagis.
English: These adverse reactions are similar in character to those after the initial five doses.
Slovenian: Ti neželeni učinki so bili po značilnostih podobni tistim po prvih petih odmerkih.
English: • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
Slovenian: • pri otrocih, mlajših od 2 let, ki so v zadnjih 6 mesecih potrebovali zdravljenje zaradi bronhopulmonalne displazije,
English: Palivizumab treatment schedule and adverse reactions were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000.
Slovenian: Shemo zdravljenja s palivizumabom in neželene učinke so spremljali v skupini skoraj 20.000 dojenčkov, ki so jih prek registra o sodelovanju bolnikov spremljali med letoma 1998 in 2000.
English: Your child can then go back to the original planned injection.
Slovenian: Vaš otrok lahko potem preide na prvoten urnik injekcij.
English: Injection volumes over 1 ml should be given as a divided dose.
Slovenian: Količine, večje od 1 ml, je treba injicirati v deljenem odmerku.
English: Synagis is not indicated for use in adults.
Slovenian: Zdravilo Synagis ni indicirano za uporabo pri odraslih.
English: Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.
Slovenian: Neželeni učinki, ugotovljeni pri bolnikih po šestem ali nadaljnjih odmerkih so bili po značilnostih in pogostnosti podobni tistim po prvih 5 odmerkih.
English: Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Slovenian: Vašega otroka zelo ogroža bolezen, ki jo povzroča virus, imenovan respiratorni sincicijski virus (RSV).
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing a uthorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: There was no association observed between the presence of antibody and adverse events.
Slovenian: Niso opazili povezave med prisotnostjo protiteles in neželenimi učinki.
English: What Synagis is and what it is used for
Slovenian: Kaj je zdravilo Synagis in za kaj ga uporabljamo
English: The solution is clear or slightly opalescent.
Slovenian: Raztopina je bistra ali rahlo opalescentna.
English: Each injection of Synagis can only help protect your child for about one month before another injection is needed.
Slovenian: Vsaka injekcija zdravila Synagis pomaga varovati otroka le približno en mesec, potem je potrebna naslednja injekcija.
English: Any remaining contents should be discarded after use.
Slovenian: Morebitni neporabljeni ostanek je treba po uporabi zavreči.
English: The overall rate and pattern of adverse events, study drug discontinuation due to AEs, and the number of deaths reported in these clinical studies were consistent with those observed during the clinical development programs for the lyophilised formulation.
Slovenian: Splošna stopnja in vzorec neželenih dogodkov, prekinitev študije zaradi neželenih dogodkov in število smrtnih primerov, o katerih so poročali v teh kliničnih študijah, so bili skladni s tistimi, ki so jih opazovali v kliničnih razvojnih programih za liofilizirano obliko.
English: This medicinal product should not be mixed with other medicinal products.
Slovenian: Tega zdravila se ne sme mešati z drugimi zdravili.
English: Data, although limited, are available on greater than 5 doses (see sections 4.8 and 5.1), therefore the benefit in terms of protection beyond 5 doses has not been established.
Slovenian: Podatki o več kot 5 odmerkih so sicer na voljo, vendar so omejeni (glejte poglavji 4.8 in 5.1), zato koristi glede zaščite pri uporabi več kot 5 odmerkov niso ugotovljene.
English: To ensure the correct volume is reconstituted for Synagis, see section 6.6.
Slovenian: Za zagotovilo, da bo rekonstituirana pravilna količina zdravila Synagis, glejte poglavje 6.6.
English: From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8).
Slovenian: Med obdobjem trženja zdravila so bili opisani primeri prevelikega odmerjanja pri odmerkih do 85 mg/kg in v nekaterih primerih so poročali o neželenih učinkih, ki se niso razlikovali od neželenih učinkov, opaženih pri odmerku 15 mg/kg (glejte poglavje 4.8).
English: The injection should be given using standard aseptic technique.
Slovenian: Za injiciranje je treba uporabiti standardni aseptični postopek.
English: A total of 1,291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season.
Slovenian: Vsega skupaj je bilo prejetih 1.291 poročil o resnih učinkih v primerih, ko je bil palivizumab uporabljen, kot je indicirano, in je trajanje zdravljenja potekalo znotraj ene sezone.
English: Ninetyeight percent of all subjects receiving palivizumab completed the study and 97% received all five injections.
Slovenian: Osemindevetdeset odstotkov vseh oseb, ki so prejemale palivizumab, je študijo zaključilo in 97 % je prejelo vseh 5 injekcij.
English: Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Slovenian: Palivizumab je treba dajati previdno bolnikom s trombocitopenijo ali katero koli motnjo koagulacije.
English: Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
Slovenian: Zato je potrebno za zdravniško odločitev uporabljati rezultate diagnostičnih testov, kadar so izvedeni, v povezavi s kliničnimi znaki.
English: The onset of the adverse reactions occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose).
Slovenian: Ta poročila so prvi pojav neželenih učinkov navajala po šestem ali nadaljnjih odmerkih le v 22 primerih (15 primerov po šestem odmerku, 6 po sedmem in 1 po osmem).
English: What Synagis is and what it is used for What you need to know before Synagis is given to your child How will my child receive Synagis Possible side effects
Slovenian: Kaj je zdravilo Synagis in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok dobil zdravilo Synagis Kako bo otrok dobival zdravilo Synagis Možni neželeni učinki
English: Subjects were stratified by cardiac lesion (cyanotic vs. other) and were followed for safety and efficacy for 150 days.
Slovenian: Osebe so bile razdeljene v podskupini glede na poškodbo srca (cianotični ali ostali) in spremljane 150 dni glede varnosti in učinkovitosti.
English: Palivizumab solution for injection does not contain a preservative, is for single use and should be administered immediately after drawing the dose into the syringe.
Slovenian: Palivizumab raztopina za injiciranje ne vsebuje konzervansa, je za enkratno uporabo in jo je treba uporabiti takoj po odvzemu odmerka v brizgo.
English: Use within 3 hours of reconstitution.
Slovenian: Uporabite v 3 urah po pripravi.
English: After reconstitution use within 3 hours.
Slovenian: Po rekonstituciji uporabite v roku 3 ur.
English: Single dose toxicology studies have been conducted in cynomolgus monkeys (maximum dose 30 mg/kg), rabbits (maximum dose 50 mg/kg) and rats (maximum dose 840 mg/kg).
Slovenian: Toksikološke raziskave pri enkratnem odmerku so bile opravljene pri opicah cynomolgus (največji odmerek 30 mg/kg), kuncih (največji odmerek 50 mg/kg) in podganah (največji odmerek 840 mg/kg).
English: The appearance of the reconstituted solution is clear to slightly opalescent.
Slovenian: Rekonstituirana raztopina je na videz bistra do rahlo opalescentna.
English: The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.
Slovenian: Glutealne mišice se ne sme uporabljati kot običajnega mesta injiciranja, ker obstaja tveganje za poškodbo bedrnega živca.
English: The primary endpoint was a summary of adverse events and serious adverse events, and the secondary endpoint was the incidence of RSV hospitalisation.
Slovenian: Primarni cilj opazovanja je bil povzetek neželenih dogodkov in resnih neželenih dogodkov, sekundarni cilj pa incidenca hospitalizacij zaradi RSV.
English: Do not mix the palivizumab liquid and lyophilised formulations.
Slovenian: Ne mešajte palivizumaba v tekoči in liofilizirani obliki.