FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Rapilysin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rapilysin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Rapilysin.
Slovenian: Ta je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rapilysin.
English: The studies looked at the number of patients who had died 30 to 35 days after treatment, and at the number of patients who had heart failure (an inability of the heart to pump enough blood around the body) or a stroke.
Slovenian: V študijah so proučevali število bolnikov, ki so umrli v 30-35 dneh po zdravljenju, ter število bolnikov, ki so imeli srčno popuščanje (stanje, pri katerem srce ne zmore črpati dovolj krvi po telesu) ali so doživeli kap.
English: Rapilysin has been studied in more than 21,000 patients in four studies.
Slovenian: Zdravilo Rapilysin so proučevali v štirih študijah, ki so zajemale več kot 21 000 bolnikov.
English: For more information about treatment with Rapilysin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rapilysin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: However, Rapilysin and heparin or aspirin must not be given in the same syringe.
Slovenian: Vendar se Rapilysin in heparin ali aspirin ne smejo dati z isto injekcijsko brizgo.
English: Treatment with Rapilysin should be started as soon as possible after the start of heart attack symptoms.
Slovenian: Zdravljenje z zdravilom Rapilysin je treba uvesti čim prej po pojavu simptomov srčnega napada.
English: The most common side effects with Rapilysin (seen in more than 1 patient in 10) are bleeding at the injection site, recurrent ischaemia (reduced blood supply to parts of the body) or angina (severe chest pain), hypotension (low blood pressure), heart failure or pulmonary oedema (build-up of fluid on the lungs), and reactions at the site of the injection, such as burning sensations.
Slovenian: Najpogostejši neželeni učinki zdravila Rapilysin (opaženi pri več kot 1 bolniku od 10) so krvavitev na mestu injiciranja, ponovitev ishemije (zmanjšanje dotoka krvi v dele telesa) ali angina pektoris (huda bolečina v prsih), hipotenzija (nizek krvni tlak), srčno popuščanje ali pljučni edem (kopičenje tekočine v pljučih) in reakcije na mestu injiciranja, kot je žgoč občutek.
English: Rapilysin must also not be used in patients who are at risk of bleeding because of other diseases, treatment with other medicines, high blood pressure, previous bleeding or recent surgery.
Slovenian: Zdravila Rapilysin ne smejo jemati tudi bolniki, pri katerih obstaja tveganje za pojav krvavitev zaradi drugih bolezni, zdravljenja z drugimi zdravili, visokega krvnega tlaka, predhodnih krvavitev ali nedavnega operativnega posega.
English: The active substance in Rapilysin, reteplase, is a copy of a natural enzyme called t-PA that has been modified so that it starts working faster and for longer.
Slovenian: Zdravilna učinkovina v zdravilu Rapilysin, reteplaza, je kopija naravnega encima t-PA, ki je bil spremenjen tako, da začne delovati hitreje in učinkuje dlje.
English: 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 use for Rapilysin.
Slovenian: 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 njegove uporabe.
English: Rapilysin was also as effective as alteplase in preventing death and stroke.
Slovenian: Zdravilo Rapilysin je bilo enako učinkovito kot alteplaza pri preprečevanju smrti in kapi.
English: Rapilysin should be prescribed by doctors who have experience in using medicines that dissolve blood clots and who can monitor its use.
Slovenian: Zdravilo Rapilysin mora predpisati zdravnik z izkušnjami z uporabo zdravil, ki raztapljajo krvne strdke in ki lahko spremlja njegovo uporabo.
English: What benefit has Rapilysin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Rapilysin izkazalo med študijami?
English: The CHMP decided that Rapilysin's benefits are greater than its risks for and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Rapilysin večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Rapilysin was more effective than streptokinase in reducing the number of patients with heart failure, and it was as effective as streptokinase in preventing death.
Slovenian: Zdravilo Rapilysin je bilo pri zmanjševanju števila bolnikov s srčnim popuščanjem učinkovitejše od streptokinaze, pri preprečevanju smrti pa enako učinkovito kot streptokinaza.
English: Rapilysin has been compared with other medicines used to dissolve blood clots: streptokinase in 6,000 patients and alteplase in about 15,000 patients.
Slovenian: Primerjali so ga z drugimi zdravili, ki se uporabljajo za raztapljanje krvnih strdkov: s streptokinazo pri 6 000 bolnikih in z alteplazo pri približno 15 000 bolnikih.
English: Other medicines that prevent clotting (aspirin and heparin) should be given before and after the Rapilysin injection to stop clots from forming again.
Slovenian: Druga zdravila, ki preprečujejo strjevanje krvi (aspirin in heparin), je treba dajati pred ali po injekciji zdravila Rapilysin, da se prepreči ponoven nastanek krvnih strdkov.
English: Rapilysin reteplase
Slovenian: Rapilysin reteplaza
English: Other information about Rapilysin
Slovenian: Druge informacije o zdravilu Rapilysin
English: For the full list of all side effects reported with Rapilysin, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rapilysin, glejte navodilo za uporabo.
English: Reteplase activates the production of an enzyme called plasmin, which breaks up blood clots.
Slovenian: Reteplaza sproži tvorbo encima, imenovanega plazmin, ki razkraja krvne strdke.
English: Rapilysin is a powder and solvent that are made up into a solution for injection.
Slovenian: Zdravilo Rapilysin je prašek in vehikel za pripravo raztopine za injiciranje.
English: It contains the active substance reteplase.
Slovenian: Vsebuje zdravilno učinkovino reteplazo.
English: What is the risk associated with Rapilysin?
Slovenian: Kakšna tveganja so povezana z zdravilom Rapilysin?
English: Rapilysin is used within 12 hours of a suspected heart attack to help dissolve the blood clots obstructing the flow of blood to the heart muscle.
Slovenian: Rapilysin se uporablja 12 ur po obstoju suma na srčni napad za raztapljanje krvnih strdkov, ki ovirajo dotok krvi v srčno mišico.
English: Following a heart attack, Rapilysin can help dissolve blood clots that have formed in the arteries supplying the heart muscle, thereby restoring normal blood flow to the heart.
Slovenian: Zdravilo Rapilysin lahko po srčnem napadu razgradi krvne strdke, nastale v arterijah, ki napajajo srčno mišico, in s tem vzpostavi normalen pretok krvi do srca.
English: Rapilysin is given as two injections, 30 minutes apart.
Slovenian: Daje se v dveh injekcijah v intervalu 30 minut.
English: Why has Rapilysin been approved?
Slovenian: Zakaj je bilo zdravilo Rapilysin odobreno?
English: How has Rapilysin been studied?
Slovenian: Kako je bilo zdravilo Rapilysin raziskano?
English: What is Rapilysin used for?
Slovenian: Za kaj se zdravilo Rapilysin uporablja?
English: What is Rapilysin?
Slovenian: Kaj je zdravilo Rapilsyin?
English: How does Rapilysin work?
Slovenian: Kako zdravilo Rapilysin deluje?
English: How is Rapilysin used?
Slovenian: Kako se zdravilo Rapilysin uporablja?
English: In these cases no special emergency action needs to be taken.
Slovenian: V takšnih primerih posebni nujni ukrepi niso potrebni.
English: • before an operation,
Slovenian: • pred operacijo,
English: Breathe normally.
Slovenian: Normalno dihajte.
English: • feeling tired.
Slovenian: • občutek utrujenosti,
English: Nebulisation should not last more than 10 to 15 minutes.
Slovenian: Nebulizacija naj ne traja dlje kot 10 do 15 minut.
English: Leave the rest in the pouch.
Slovenian: Preostanek pustite v vrečici.
English: The recommended initial doses are:
Slovenian: Priporočeni začetni odmerki so:
English: • during admission to hospital after a serious accident,
Slovenian: • med hospitalizacijo po resni nesreči,
English: The HPA-axis function will recover within 1-2 days.
Slovenian: Delovanje osi HPA se obnovi v 1 do 2 dneh.
English: hours after first opening.
Slovenian: urah po prvem odprtju.
English: • You have an infection in your chest.
Slovenian: • Imate okužbo v prsnem košu.
English: • You are being, or have ever been, treated for tuberculosis (TB).
Slovenian: • Če se zdravite ali ste se kadar koli zdravili zaradi tuberkuloze (TB).
English: Do not use with ultrasonic nebulisers.
Slovenian: Ne uporabljajte z ultrazvočnimi nebulatorji.
English: Marketing Authorisation Holder: {See ANNEX I of referal} Manufacturer: Chiesi Farmaceutici S.p.A., 26/A via Palermo, 43122 Parma, Italy.
Slovenian: Imetnik dovoljenja za promet z zdravilom: {Glejte PRILOGO I } Izdelovalec: Chiesi Farmaceutici S.p.A., 26/A via Palermo, 43122 Parma, Italija.
English: The two treatments were equally well tolerated (Bisca et al., 2003).
Slovenian: Obe zdravljenji so bolniki enako dobro prenašali (Bisca et al., 2003).
English: • treatment of recurrent wheezing in children up to 5 years of age (see sections 4.2 and 4.4 paediatric population).
Slovenian: • zdravljenje ponavljajočega se piskajočega dihanja pri otrocih do 5. leta starosti (glejte poglavje 4.2 in poglavje 4.4, Pediatrična populacija).
English: The dose may then be adjusted by your doctor until effective control of symptoms is reached.
Slovenian: Odmerek bo morda nato zdravnik prilagodil, dokler ne bo doseženo učinkovito obvladovanje simptomov.
English: It is important that your nebuliser is kept clean.
Slovenian: Pomembno je, da je vaš nebulator vedno čist.
English: Affected children and adolescents may grow more slowly than others, so it is important that they will have their height checked regularly by their doctor.
Slovenian: Prizadeti otroci in mladostniki lahko rastejo počasneje kot drugi, zato je pomembno, da zdravnik redno spremlja njihovo višino.
English: The benefits of breastfeeding are likely to outweigh any theoretical risk.
Slovenian: Verjetno bodo koristi dojenja večje od vseh teoretičnih tveganj.
English: Your doctor will decide the duration of your treatment.
Slovenian: Vaš zdravnik se bo odločil, kako dolgo bo trajalo vaše zdravljenje.
English: Some patients feel unwell for approximately 2 weeks during the withdrawal of treatment with systemic corticosteroids, even though their respiratory function remains the same or even improves.
Slovenian: Nekateri bolniki se približno 2 tedna med odtegnitvijo zdravljenja s sistemskimi kortikosteroidi ne počutijo dobro, kljub temu, da je njihova dihalna funkcija ostala enaka ali je celo izboljšana.
English: [to be completed nationally]
Slovenian: [izpolni država članica]
English: Normally, a daily dose of 3200 micrograms in adults and adolescents and 1600 micrograms in children up to 11 years of age should not be exceeded.
Slovenian: Običajno dnevnega odmerka 3.200 mikrogramov pri odraslih in mladostnikih in 1.600 mikrogramov pri otrocih do 11. leta starosti ni dovoljeno preseči.
English: • tremor (involuntary trembling)
Slovenian: • tremor (nehoteno tresenje),
English: The remaining quantity has to be used within 12 hours after first opening.
Slovenian: Preostalo količino morate uporabiti v 12 urah po prvem odprtju.
English: During this time your doctor will monitor the level of corticosteroids in your body regularly.
Slovenian: Med tem časom bo zdravnik redno spremljal raven kortikosteroidov v vašem telesu.
English: Measures to minimize the occurrence of candidiasis, hoarseness and paradoxical bronchospasm are described in section 4.4.
Slovenian: Ukrepi za zmanjšanje pojava kandidoze, hripavosti in paradoksnega bronhospazma so opisani v poglavju 4.4.
English: Carefully squeeze out the content until the level of suspension in the ampoule reaches the graduation mark and no further.
Slovenian: Previdno stiskajte vsebino, dokler raven suspenzije v ampuli ne doseže oznake in nič dlje.
English: Both treatments were associated with a marked reduction in night-time wheezing and in the number of days of steroid use.
Slovenian: Obe zdravljenji sta bili povezani z znatnim zmanjšanjem nočnega piskajočega dihanja in v številu dni uporabe steroidov.
English: In this case monitoring of adrenal function is recommended.
Slovenian: V tem primeru se priporoča spremljanje delovanja nadledvičnih žlez.
English: Nebuliser suspension 10 ampoules
Slovenian: suspenzija za nebulator 10 ampul
English: This should be treated immediately with a fast-acting inhaled bronchodilator.
Slovenian: To je treba takoj zdraviti s hitrodelujočim inhalacijskim bronhodilatatorjem.
English: Although results of animal studies have shown some impaired fertility, this occurs at high doses levels.
Slovenian: Čeprav rezultati študij na živalih kažejo določeno okvaro plodnosti, se je ta pojavila pri velikih odmerkih.
English: In terms of safety, no change in the values of morning salivary cortisol was detected (Papi et al., 2009).
Slovenian: Kar zadeva varnost, niso ugotovili spremembe jutranjih vrednosti kortizola v slini (Papi et al., 2009).
English: Animal studies have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Beclometasone dipropionate demonstrated to be non-genotoxic.
Slovenian: Pokazalo se je, da beklometazondipropionat ni genotoksičen.
English: • or if you have a chest infection or other serious illness.
Slovenian: • če imate okužbo v prsnem košu ali drugo resno bolezen.
English: Regular follow-up is essential to review the treatment response.
Slovenian: Potrebno je redno spremljanje, da se oceni odziv na zdravljenje.
English: Herpes simplex
Slovenian: Pogosti herpes simpleks
English: Adults and adolescents (from 12 years of age) :
Slovenian: Odrasli in mladostniki (od 12. leta starosti):
English: 2, 4 or 8 pouches are packed into a carton, i.e. each carton contains 10, 20 or 40 ampoules.
Slovenian: Po 2, 4 ali 8 vrečic je zapakiranih v škatlo, tj. vsaka škatla vsebuje 10, 20 ali 40 ampul.
English: • If you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.
Slovenian: • če ste alergični na zdravilno učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Hoarseness is reversible and disappears after discontinuation of treatment and / or rest of the voice.
Slovenian: Hripavost je reverzibilna in izzveni po prekinitvi zdravljenja in/ali počivanju glasu.
English: If you have used more {INVENTED NAME} than you should, tell your doctor as soon as possible.
Slovenian: Če ste uporabili več zdravila {IZMIŠLJENO IME}, kot bi smeli, to čim prej povejte zdravniku.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojni organi držav članic lahko v nadaljevanju posodobijo informacije o zdravilu v povezavi z referenčno državo članico, kot je ustrezno, v skladu s postopki iz poglavja 4
English: Special care is necessary in patients with active or quiescent pulmonary tuberculosis and other infections.
Slovenian: Posebna pozornost je potrebna pri bolnikih z aktivno ali mirujočo pljučno tuberkulozo in drugimi okužbami.
English: If it is almost time for your next dose, do not use the missed dose, just use the next dose when it is due.
Slovenian: Če je že skoraj čas za naslednji odmerek, ne nadomestite izpuščenega odmerka, temveč uporabite naslednjega, ko je čas.
English: Patients should be advised to carefully follow the manufacturer's instructions for the nebulizer device and should only use the settings recommended.
Slovenian: Bolnikom je treba svetovati, naj natančno upoštevajo izdelovalčeva navodila za nebulator in uporabijo priporočene nastavitve.
English: These allergies should be symptomatically treated with antihistamines and/or topical medicinal product, including steroids for local use.
Slovenian: Te alergije je treba zdraviti simptomatsko z antihistaminiki in/ali lokalnimi zdravili, vključno s steroidi za lokalno uporabo.
English: {INVENTED NAME} is indicated for the:
Slovenian: Zdravilo {IZMIŠLJENO IME} je indicirano za:
English: {INVENTED NAME}
Slovenian: {IZMIŠLJENO IME}
English: In any case, beclometasone dipropionate should be administered without discontinuing the systemic treatment; after approximately one week, the latter should be gradually reduced (the size of the reduction should correspond to the maintenance dose of the systemic steroid), patient should be checked at regular intervals (in particular, adrenocortical function tests should be carried out) and dose of inhaled beclometsone dipropionate should be adjusted according to the results obtained.
Slovenian: V vsakem primeru je treba beklometazondipropionat dajati brez prekinitve sistemskega zdravljenja; po približno enem tednu je treba slednjega počasi zmanjševati (obseg zmanjševanja mora ustrezati vzdrževalnemu odmerku sistemskih steroidov), bolnike je treba v rednih intervalih preverjati (opravljati je treba zlasti teste adrenokortikalne funkcije) in odmerek inhaliranega beklometazondipropionata prilagajati ustrezno glede na pridobljene rezultate.
English: Plasma protein binding is moderately high.
Slovenian: Porazdelitev Vezava na beljakovine v plazmi je zmerno velika.
English: Corticosteroids pass into breast milk at low amounts.
Slovenian: Kortikosteroidi v majhnih količinah prehajajo v materino mleko.
English: For instruction on preparation and dilution of the medicinal product, see section 6.6.
Slovenian: Za navodila glede priprave in redčenja zdravila pred dajanjem glejte poglavje 6.6.
English: Your doctor may prescribe a course of antibiotics.
Slovenian: Zdravnik vam bo morda predpisal antibiotike.
English: Therefore the majority of the effect is related to B17MP systemic exposure.
Slovenian: Večina učinka je zato povezana s sistemsko izpostavljenostjo B17MP.
English: Children (up 11 years of age):
Slovenian: Otroci (do 11.leta starosti):
English: If growth impairment occurs, the treatment should be assessed with the aim of reducing the dose of inhaled corticosteroid.
Slovenian: Če se pojavi vpliv na rast, je treba zdravljenje oceniti s ciljem zmanjšanja odmerka inhaliranega kortikosteroida.
English: Strips of 5 ampoules are packed in a heat sealed pouch of PET/Al/PE (Polyethylene Terephthalate/Aluminium/Polyethylene).
Slovenian: Trakovi s 5 ampulami so pakirani v toplotno zavarjeno vrečico iz PET/Al/PE (polietilen tereftalat/aluminij/polietilen).
English: Your doctor may want to check the corticosteroid levels in your blood and therefore, may need to take a blood sample.
Slovenian: Vaš zdravnik bo morda preveril raven kortikosteroidov v krvi, zato vam bo morda odvzel vzorec krvi.
English: If treatment during pregnancy is necessary, the lowest effective dose of beclometasone dipropionate should be used.
Slovenian: Če je potrebno zdravljenje med nosečnostjo, je treba uporabiti najmanjši učinkoviti odmerek beklometazondipropionata.
English: As BDP or its metabolites were not traced in urine, an increase in systemic exposure is not envisaged in patients with renal impairment.
Slovenian: Ker BDP ali njegovih presnovkov v urinu niso zaznali, ni pričakovati povečanja sistemske izpostavljenosti pri bolnikih z okvarjenimi ledvicami.
English: Patients should be advised to have such relief medicinal product readily available.
Slovenian: Bolnikom je treba svetovati, naj imajo vedno pri sebi to olajševalno zdravilo.
English: Severe exacerbations of asthma must be treated in the normal way, e.g. by increasing the dose of inhaled beclometasone dipropionate and, if necessary, by giving a systemic steroid, and/or an antibiotic if appropriate, and by use of beta 2-agonist therapy.
Slovenian: Hudo poslabšanje astme je treba zdraviti na običajen način, npr. s povečanjem odmerka inhaliranega beklometazondipropionata in po potrebi s sistemskim steroidom in/ali antibiotikom, če je ustrezno, ter z uporabo beta2-agonista.
English: In patients with asthma, {INVENTED NAME} must be used regularly on a daily basis; the duration of treatment should be defined on the basis of symptoms.
Slovenian: Pri bolnikih z astmo je treba zdravilo {IZMIŠLJENO IME} uporabljati redno vsak dan; trajanje zdravljenja je treba določiti glede na simptome.
English: You should not increase or decrease your dose without seeking medical advice.
Slovenian: Odmerka ne povečajte in ne zmanjšajte, ne da bi se posvetovali z zdravnikom.
English: PHARMACEUTICAL FORM AND CONTENTS Nebuliser suspension
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za nebulator
English: If patients find that short-acting relief bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.
Slovenian: Če bolnik ugotovi, da postane zdravljenje s kratkodelujočim bronhodilatatorjem manj učinkovito ali če potrebuje več inhalacij kot običajno, se mora posvetovati z zdravnikom.
English: 20 ampoules
Slovenian: 20 ampul
English: The starting dose should be prescribed by your doctor according to the frequency and severity of your disease.
Slovenian: Začetni odmerek vam bo predpisal zdravnik glede na pogostnost in resnost bolezni.
English: Your doctor will decide if you need a course of corticosteroid tablets or possibly a corticosteroid injection and will also advise you as to how long you need to take the course of corticosteroid tablets and how you should reduce these as you get better.
Slovenian: Vaš zdravnik se bo odločil, ali potrebujete kortikosteroidne tablete ali morda injekcijo kortikosteroidov in vam svetoval, kako dolgo naj bo zdravljenje s kortikosteroidnimi tabletami in kako jih zmanjšati, ko boste okrevali.
English: 40 ampoules
Slovenian: 40 ampul
English: If your child suffers from recurrent wheezing, the duration of treatment should not exceed 3 months, unless otherwise prescribed by the paediatrician.
Slovenian: Če ima vaš otrok ponavljajoče se piskajoče dihanje, zdravljenje ne sme trajati več kot 3 mesece, razen če pediater ni določil drugače.
English: Instructions for use: Use the ampoule according to the following instructions:
Slovenian: Navodila za uporabo: Uporabite ampule v skladu z naslednjimi navodili:
English: Repeat this operation, until the whole content is fully dispersed and mixed (Figure C).
Slovenian: Ta postopek ponavljajte, dokler se vsa vsebina popolnoma ne raztopi in premeša (slika C).
English: Repeat this operation, until the whole content is fully re-dispersed and mixed (Figure C).
Slovenian: Ta postopek ponavljajte, dokler se vsa vsebina ne redispergira in popolnoma premeša (slika C).
English: Do not forget to rinse the mouth, lips and the region of the face covered by the mask with water.
Slovenian: Po uporabi nebulatorja Ne pozabite si ust, ustnic in predela obraza, prekritega z masko, izplakniti z vodo.