FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 10-2011.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2011.
English: Similar results were seen in the second study.
Slovenian: Podobni rezultati so bili ugotovljeni tudi v drugi študiji.
English: Other information about Aerinaze
Slovenian: Druge informacije o zdravilu Aerinaze
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze on 30 July 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Aerinaze, veljavno po vsej Evropski uniji, odobrila dne 30. julija 2007.
English: The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients.
Slovenian: Učinkovitost zdravila Aerinaze so proučevali v dveh glavnih študijah s skupno 1 248 odraslimi in mladostniki.
English: The full EPAR for Aerinaze 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 Aerinaze je na voljo na spletni strani agencije: : ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What benefit has Aerinaze shown during the studies?
Slovenian: Kakšne koristi je zdravilo Aerinaze izkazalo med študijami?
English: In adults and adolescents over 12 years of age, the recommended dose of Aerinaze is one tablet twice a day, taken whole with a full glass of water.
Slovenian: Pri odraslih in mladostnikih, starejših od 12 let, je priporočeni odmerek zdravila Aerinaze ena tableta dvakrat dnevno, ki jo je treba pogoltniti celo s polnim kozarcem vode.
English: This is a summary of the European public assessment report (EPAR) for Aerinaze.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aerinaze.
English: It is available as blue and white modified-release tablets.
Slovenian: Na voljo je v obliki modrih in belih tablet s prirejenim sproščanjem.
English: The main measures of effectiveness were the change in the severity of hayfever symptoms reported by the patients between before treatment started, and over the entire 15 days of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba resnosti simptomov senenega nahoda, o katerih so bolniki poročali pred začetkom zdravljenja in v celotnem 15-dnevnem obdobju zdravljenja.
English: For more information about treatment with Aerinaze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Aerinaze preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Treatment should continue for as short a time as possible and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared.
Slovenian: Zdravljenje naj bo čim krajše in ga je treba ustaviti, kakor hitro simptomi, zlasti kongestija (zamašen nos), izginejo.
English: It should not be used in people who are taking a monoamine oxidase inhibitor (such as some medicines used to treat depression) or who have stopped taking one of these medicines within the last two weeks.
Slovenian: Ne smejo ga uporabljati osebe, ki se zdravijo z zaviralci monoaminooksidaze (na primer z nekaterimi zdravili za zdravljenje depresije) ali ki so v zadnjih dveh tednih prenehale jemati katero izmed teh zdravil.
English: What is the risk associated with Aerinaze?
Slovenian: Kakšna tveganja so povezana z zdravilom Aerinaze?
English: When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Slovenian: Če so receptorji blokirani, histamin ne more učinkovati, zaradi česar se zmanjšajo simptomi alergije.
English: The patients recorded their symptoms in a diary every 12 hours during the study, scoring on a standard symptom scale how severe the symptoms were over the previous 12-hour period.
Slovenian: Bolniki so med študijo beležili simptome v dnevnik vsakih 12 ur in ocenjevali njihovo resnost v preteklem 12-urnem obdobju s pomočjo standardne lestvice za ocenjevanje simptomov.
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 Aerinaze.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Aerinaze, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
Slovenian: To zmanjša količino tekočine, ki se sprošča iz žil, kar vodi do zmanjšanja otekanja in nastajanja sluzi v nosu.
English: Desloratadine is released from its layer immediately after it is taken, while pseudoephedrine is released slowly over 12 hours.
Slovenian: Desloratadin se iz svoje plasti začne sproščati takoj po zaužitju tablete, medtem ko se psevdoefedrin sprošča počasi v obdobju 12 ur.
English: Why has Aerinaze been approved?
Slovenian: Zakaj je bilo zdravilo Aerinaze odobreno?
English: Aerinaze is a medicine containing the active substances desloratadine (2.5 mg) and pseudoephedrine (120 mg).
Slovenian: Aerinaze je zdravilo, ki vsebuje zdravilni učinkovini desloratadin (2,5 mg) in psevdoefedrin (120 mg).
English: When looking at nasal congestion, patients taking Aerinaze had a reduction in symptoms of 37.4%, compared with 26.7% in those taking desloratadine alone.
Slovenian: Z vidika obravnave kongestije nosne sluznice so se pri bolnikih, ki so jemali zdravilo Aerinaze, simptomi zmanjšali za 37,4 %, pri bolnikih, ki so jemali samo desloratadin, pa za 26,7 %.
English: ‘Modified-release' means that the tablets have been made to allow one of the active substances to be released immediately and the other one released over a few hours.
Slovenian: Prirejeno sproščanje pomeni, da so tablete izdelane tako, da omogočajo sprostitev ene zdravilne učinkovine takoj, druga pa se sprošča več ur.
English: When looking at all hayfever symptoms except for nasal congestion, patients taking Aerinaze reported a reduction in symptoms of 46.0%, compared with 35.9% in those taking pseudoephedrine alone.
Slovenian: Z vidika obravnave vseh simptomov senenega nahoda z izjemo kongestije nosne sluznice so bolniki, ki so jemali zdravilo Aerinaze, poročali o zmanjšanju simptomov za 46,0 %, v primerjavi z zmanjšanjem za 35,9 % pri bolnikih, ki so jemali samo psevdoefedrin.
English: Aerinaze was more effective in reducing symptoms than either of the two active substances taken alone.
Slovenian: Zdravilo Aerinaze je bilo pri zmanjševanju simptomov učinkovitejše od obeh zdravilnih učinkovin, uporabljenih samostojno.
English: For the full list of all side effects reported with Aerinaze, see the Package Leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Aerinaze, glejte navodilo za uporabo.
English: Desloratadine/pseudoephedrine
Slovenian: Povzetek EPAR za javnost desloratadin/psevdoefedrin
English: In Aerinaze, the two active substances are used together, since an antihistamine alone may not provide adequate relief for patients with nasal congestion.
Slovenian: V zdravilu Aerinaze sta obe zdravilni učinkovini uporabljeni v kombinaciji, saj sam antihistaminik ne bi zagotovil ustreznega olajšanja pri bolnikih s kongestijo nosne sluznice.
English: The most common side effects with Aerinaze (seen in between 1 and 10 patients in 100) are tachycardia (fast heart rate), dry mouth, dizziness, psychomotor hyperactivity (restlessness), pharyngitis (sore throat), anorexia (loss of appetite), constipation, headache, fatigue (tiredness), insomnia (difficulty sleeping), somnolence (sleepiness), sleep disorders and nervousness.
Slovenian: Najpogostejši neželeni učinki zdravila Aerinaze (opaženi pri 1 do 10 bolnikih od 100) so tahikardija (pospešeno bitje srca), suha usta, omotica, psihomotorična hiperaktivnost (nemirnost), faringitis (vneto žrelo), anoreksija (izguba teka), zaprtje, glavobol, utrujenost, nespečnost, zaspanost, motnje spanja in živčnost.
English: Desloratadine has been available in the European Union (EU) since 2001, and pseudoephedrine is widely used in medicines that have been available over-the-counter for many years.
Slovenian: To pomeni, da morajo bolniki tableto vzeti samo dvakrat na dan. Desloratadin je na voljo v Evropski uniji (EU) od leta 2001, psevdoefedrin pa se že vrsto let pogosto uporablja v zdravilih, ki se izdajajo brez recepta.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Aerinaze's benefits are greater than its risks for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion and recommended that Aerinaze be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Aerinaze pri simptomatskem zdravljenju sezonskega alergijskega rinitisa, ki ga spremlja kongestija nosne sluznice, večje od z njim povezanih tveganj in priporočil, da se zanj odobri dovoljenje za promet z zdravilom.
English: Pseudoephedrine works by stimulating nerve endings to release the chemical noradrenaline, which causes the blood vessels to constrict (narrow).
Slovenian: Psevdoefedrin spodbuja živčne končiče, da sproščajo kemijsko snov noradrenalin, ki povzroča zožitev krvnih žil.
English: Aerinaze must not be used in people who are hypersensitive (allergic) to desloratadine, pseudoephedrine or any of the other ingredients, to adrenergic agents or to loratadine (another medicine used to treat allergies).
Slovenian: Zdravila Aerinaze ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) desloratadin, psevdoefedrin ali katero koli drugo sestavino zdravila, adrenergične učinkovine ali loratadin (drugo zdravilo za zdravljenje alergij).
English: Aerinaze should also not be taken by people who have narrow angle glaucoma (increased pressure inside the eye), urinary retention (difficulty in passing urine), heart or blood vessel diseases including hypertension (high blood pressure), hyperthyroidism (an overactive thyroid gland), or a history or risk of haemorrhagic stroke (stroke caused by bleeding within the brain).
Slovenian: Prav tako zdravila Aerinaze ne smejo jemati osebe, ki imajo glavkom ozkega zakotja (povečan tlak v notranjosti očesa), zastoj seča (težave pri izločanju seča), srčnožilne bolezni, vključno s hipertenzijo (visokim krvnim tlakom), hipertiroidizem (povečano delovanje ščitnice) ali anamnezo oziroma tveganje za hemoragično možgansko kap (kap zaradi krvavitve v možganih).
English: Desloratadine works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Slovenian: Desloratadin deluje kot zaviralec receptorjev, na katere se običajno veže histamin, tj. snov v telesu, ki povzroča alergijske simptome.
English: Aerinaze tablets have two layers, one containing desloratadine, and the other containing pseudoephedrine.
Slovenian: Tablete zdravila Aerinaze so dvoplastne, ena plast vsebuje desloratadin, druga pa psevdoefedrin.
English: What is Aerinaze?
Slovenian: Kaj je zdravilo Aerinaze?
English: Aerinaze is used to treat the symptoms of seasonal allergic rhinitis (hayfever, inflammation of the nasal passages caused by an allergy to pollen) in patients who have nasal congestion (a blocked nose).
Slovenian: Zdravilo Aerinaze se uporablja za zdravljenje simptomov sezonskega alergijskega rinitisa (senenega nahoda, vnetja nosnih poti zaradi preobčutljivosti na cvetni prah) pri bolnikih s kongestijo nosne sluznice (zamašenim nosom).
English: In both studies, Aerinaze was compared with desloratadine alone and with pseudoephedrine alone.
Slovenian: V obeh študijah so zdravilo Aerinaze primerjali z desloratadinom kot samostojnim zdravilom in psevdoefedrinom kot samostojnim zdravilom.
English: What is Aerinaze used for?
Slovenian: Za kaj se zdravilo Aerinaze uporablja?
English: Treatment for more than 10 days is not advisable, as the medicine's effects on nasal congestion may wear off. Once the nose has cleared, patients can use desloratadine alone.
Slovenian: Zdravljenje, daljše od 10 dni, ni priporočljivo, saj učinek zdravila na kongestijo nosne sluznice sčasoma pojenja.
English: Aerinaze contains two active substances: desloratadine, an antihistamine, and pseudoephedrine, which is a nasal decongestant.
Slovenian: Zdravilo Aerinaze vsebuje dve zdravilni učinkovini: desloratadin, ki je antihistaminik, in psevdoefedrin, ki je nosni dekongestiv.
English: How has Aerinaze been studied?
Slovenian: Kako je bilo zdravilo Aerinaze raziskano?
English: How does Aerinaze work?
Slovenian: Kako zdravilo Aerinaze deluje?
English: How is Aerinaze used?
Slovenian: Kako se zdravilo Aerinaze uporablja?
English: Date of first authorisation: 25 July 2013.
Slovenian: Datum prve odobritve: 25. julij 2013.
English: There is no evidence that such an interaction would be harmful.
Slovenian: Ni dokazov, da bi bilo tako medsebojno delovanje škodljivo.
English: Find a comfortable, well-lit place.
Slovenian: Najdite udobno, dobro osvetljeno mesto.
English: *This is based on protein content only.
Slovenian: *To temelji le na vsebnosti beljakovine.
English: This could damage the safety device.
Slovenian: To bi lahko poškodovalo varnostni pripomoček.
English: The safety device will be activated immediately.
Slovenian: Varnostni pripomoček se takoj aktivira.
English: The relevance of these findings for humans is not known.
Slovenian: Pomen teh ugotovitev za človeka ni znan.
English: Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Slovenian: Pravilno zdravljenje vaše bolezni zahteva tesno in stalno sodelovanje z vašim zdravnikom.
English: CI = confidence interval
Slovenian: IZ = interval zaupanja
English: Healthy volunteers
Slovenian: Zdravi prostovoljci
English: The results of the study are presented in table 3.
Slovenian: Rezultati študije so predstavljeni v preglednici 3.
English: Date of latest renewal: 08 May 2018
Slovenian: Datum zadnjega podaljšanja: 08. maj 2018.
English: This antibody response can, in some cases, lead to undesirable effects or loss of efficacy.
Slovenian: Ta protitelesni odziv lahko v nekaterih primerih povzroči neželene učinke ali izgubo učinkovitosti.
English: This should be considered when interpreting bone-imaging results.
Slovenian: To je treba upoštevati pri razlagi rezultatov slikanja kosti.
English: Incidence (%)
Slovenian: Incidenca (%)
English: The incidence of FN varied according to age (from 14.3 % to 71.4 %), with the highest frequency in the oldest age group.
Slovenian: Incidenca FN se je glede na starost razlikovala (od 14,3 % do 71,4 %), pri čemer je bila največja pogostnost v najstarejši starostni skupini.
English: Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Slovenian: Vaš zdravnik bo z rednimi krvnimi preiskavami zagotavljal nadzor nad različnimi sestavinami krvi in njihovimi ravnmi.
English: Do not give this medicine to children and adolescents under 18 years of age because there is only limited experience in children to show that this medicine is safe and works in this age group.
Slovenian: Tega zdravila ne dajajte otrokom in mladostnikom, starim manj kot 18 let, saj so izkušnje pri otrocih, ki bi dokazale, da je to zdravilo varno in da deluje v tej starostni skupini, omejene.
English: The first injection should be performed under direct medical supervision.
Slovenian: Prvo injiciranje je treba izvesti pod neposrednim zdravniškim nadzorom.
English: Frequency groupings are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Skupine pogostnosti so opredeljene v skladu z naslednjim dogovorom: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The mean terminal half-lives in the fourth cycle were approximately 39 and 42 hours.
Slovenian: Povprečna končna razpolovna časa v četrtem ciklu sta bila približno 39 in 42 ur.
English: Nevertheless, pharmacodynamic effects were similar and independent from gender and injection site.
Slovenian: Kljub temu pa so bili farmakodinamični učinki podobni in neodvisni od spola in mesta injiciranja.
English: If there are particles in it or if it is cloudy, you must not use it.
Slovenian: Če so v njej delci ali je motna, je ne smete uporabiti.
English: Do not use this medicine if you notice that it is cloudy or there are particles in it.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je motno ali da so v njem delci.
English: Do not warm Lonquex in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Zdravila Lonquex ne smete ogrevati na kak drug način (ne ogrevajte ga na primer v mikrovalovni pečici ali v vroči vodi).
English: If a patient fails to respond to treatment, the patient should undergo further evaluation.
Slovenian: Če se bolnik na zdravljenje ne odzove, ga je treba dodatno oceniti.
English: Some cases of splenic rupture were fatal.
Slovenian: Nekateri primeri raztrganja vranice so bili smrtni.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as the doctor may decide that you should not use this medicine.
Slovenian: Pomembno je, da zdravniku poveste, ali ste noseči, menite, da ste noseči ali nameravate zanositi, saj se zdravnik lahko odloči, da zdravila ne smete uporabljati.
English: ITT = Intent-to-treat population (all randomised patients) SD = standard deviation d = days
Slovenian: ITT = populacija z namenom zdravljenja (Intent-to-treat) (vsi randomizirani bolniki) SD = standardna deviacija d = dni
English: Therefore, no adjustment of the dose is necessary for elderly patients.
Slovenian: Zato pri starejših bolnikih prilagoditev odmerka ni potrebna.
English: The average molecular mass is approximately 39 kDa of which the protein moiety constitutes approximately 48 %.
Slovenian: Povprečna molekulska masa je približno 39 kDa, od tega predstavlja beljakovinski del približno 48 %.
English: If white blood cells fall to a low level, there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Slovenian: Če pade število belih krvnih celic na nizko raven, jih morda v telesu ne bo dovolj za boj proti bakterijam in lahko boste izpostavljeni večjemu tveganju za okužbo.
English: If you have a fever or any of these symptoms, it is important to contact your doctor immediately.
Slovenian: Če imate zvišano telesno temperaturo ali katerega od teh simptomov, je pomembno, da se takoj posvetujete z zdravnikom.
English: ● Risk Management Plan (RMP)
Slovenian: ZDRAVILA • Načrt za obvladovanje tveganj (RMP)
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: These cells are very sensitive to the effects of chemotherapy which can cause the number of these cells in your body to decrease.
Slovenian: Te celice so zelo občutljive na učinke kemoterapije, ki lahko povzroči zmanjšanje števila teh celic v telesu.
English: White blood cells are important as they help your body fight infection.
Slovenian: Bele krvne celice so pomembne, saj telesu pomagajo v boju proti okužbam.
English: Median ANC (x 109 cells/l)
Slovenian: Mediana vrednost ANC (x 109 celic/l)
English: Tell your doctor if you experience these symptoms.
Slovenian: Povejte zdravniku, če se pri vas pojavijo ti simptomi.
English: Most biological medicinal products elicit some level of anti-drug antibody response.
Slovenian: Večina bioloških zdravil izzove določeno stopnjo protitelesnega odziva na zdravilo.
English: This may result in lowered pharmacodynamic responses in heavy patients (> 95 kg).
Slovenian: To lahko povzroči manjše farmakodinamične odzive pri debelih bolnikih (> 95 kg).
English: Your doctor may suggest that you learn how to inject yourself with this medicine.
Slovenian: Vaš zdravnik vam lahko predlaga, da se naučite, kako si zdravilo injicirate sami.
English: Your doctor or nurse will give you instructions on how to do this.
Slovenian: Vaš zdravnik ali medicinska sestra vas bosta o tem poučila.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Allergic reactions and immunogenicity
Slovenian: Alergijske reakcije in imunogenost
English: Take the medicine out of the refrigerator.
Slovenian: Zdravilo vzemite iz hladilnika.
English: How are the injections given?
Slovenian: Kako se dajejo injekcije?
English: If you have missed an injection, contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste izpustili injekcijo, se posvetujte z zdravnikom, kdaj naj si injicirate naslednji odmerek.
English: It is unknown whether the active substance in this medicine passes into the breast milk.
Slovenian: Ni znano, ali učinkovina tega zdravila prehaja v materino mleko.
English: Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
English: If you think you are having this type of reaction, you must stop your Lonquex injection and get medical help immediately.
Slovenian: Če menite, da imate to vrsto reakcije, morate prenehati z injiciranjem zdravila Lonquex in takoj poiskati zdravniško pomoč.
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba tržno ime in številko serije uporabljenega zdravila jasno zabeležiti v bolniško kartoteko.
English: See leaflet for further information.
Slovenian: Za več informacij glejte navodilo.
English: Self-administration of Lonquex should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Slovenian: Samoinjiciranje zdravila Lonquex lahko izvajajo le bolniki, ki so dobro motivirani, ustrezno usposobljeni in imajo dostop do nasveta strokovnjaka.
English: • if you are allergic to lipegfilgrastim or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na lipegfilgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Only use each syringe for one injection.
Slovenian: Vsako injekcijsko brizgo uporabite samo za eno injiciranje.
English: Do not remove the needle cover from the syringe until you are ready to inject.
Slovenian: Ne snemajte pokrovčka igle z injekcijske brizge, dokler niste pripravljeni na injiciranje.
English: Tell your doctor if you experience severe musculoskeletal pain.
Slovenian: Obvestite zdravnika, če se pri vas pojavi huda mišično-skeletna bolečina.
English: Pull straight as shown in pictures 2 and 3.
Slovenian: Potegnite ga naravnost, kot prikazujeta sliki 2 in 3.
English: Haematopoietic system
Slovenian: Hematopoetski sistem