FrancophonIA/ELRC3.0 huggingface dataset:
English: Tracleer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Croatian: Tracleer se izdaje samo na recept, a terapiju mora započeti i pratiti samo liječnik s iskustvom u liječenju PAH-a ili sistemske skleroze.
English: The ‘class' reflects the severity of the disease: ‘class III' PAH involves marked limitation of physical activity.
Croatian: „Stupanj” se odnosi na težinu bolesti: „III. stupanj ” PAH-a podrazumijeva značajno ograničenje fizičke aktivnosti.
English: The active substance in Tracleer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Croatian: Djelatna tvar lijeka Tracleer, bosentan, inhibira prirodni hormon naziva endotelin-1 (ET-1) koji uzrokuje sužavanje krvnih žila.
English: For more information about using Tracleer, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Tracleer pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Tracleer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Croatian: Tracleer se može koristiti i u odraslih osoba sa sistemskom sklerozom, u kojih slaba cirkulacija uzrokovana bolešću rezultira razvojem „digitalnih ulceracija“ (rana na prstima ruku i nogu).
English: Tracleer contains the active substance bosentan.
Croatian: Tracleer sadrži djelatnu tvar bosentan.
English: In PAH, severe narrowing of the blood vessels in the lungs increases blood pressure and reduces the amount of blood entering the lungs.
Croatian: Ozbiljno suženje krvnih žila u plućima kod bolesti PAH povećava krvni tlak i smanjuje količinu krvi koja ulazi u pluća.
English: Why has Tracleer been approved?
Croatian: Zašto je lijek Tracleer odobren?
English: In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers.
Croatian: U bolesnika sa sistemskom sklerozom i bolešću digitalnih ulceracija dolazi do sužavanja krvnih žila u prstima na rukama i nogama, što dovodi do nastanka ulceracija.
English: Tracleer is given to reduce the number of new digital ulcers.
Croatian: Lijek Tracleer daje se radi smanjenja pojave novih digitalnih ulceracija.
English: In PAH, Tracleer film-coated tablets added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Croatian: Filmom obložene tablete lijeka Tracleer dodane postojećoj terapiji bolesnika s PAH-om bile su učinkovitije od placeba (prividno liječenje) u pogledu povećanja udaljenosti koju su bolesnici nakon šesnaest tjedana terapije mogli prehodati u šest minuta (način mjerenja kapaciteta fizičkog opterećenja).
English: In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Tracleer and placebo groups.
Croatian: U ispitivanju provedenom na 185 bolesnika s II. stupnjem bolesti udaljenost koju su bolesnici uspjeli prehodati u šest minuta bila je slična u skupini koja je primala lijek Tracleer, kao i u skupini koja je primala placebo.
English: Tracleer therefore prevents blood vessels from narrowing.
Croatian: Tracleer stoga sprječava sužavanje krvnih žila.
English: The second study which also looked at the effect of Tracleer on digital ulcer healing in 190 patients did not find any effect.
Croatian: U drugom ispitivanju na 190 bolesnika, u kojem se također promatrao učinak lijeka Tracleer na zacjeljivanje digitalnih ulceracija, nije utvrđen učinak.
English: What benefits of Tracleer have been shown in studies?
Croatian: Koje su koristi od lijeka Tracleer utvrđene u ispitivanjima?
English: The dispersible tablets should be mixed with a little water on a spoon before being taken.
Croatian: Prije uzimanja tablete za oralnu suspenziju trebaju se otopiti u malo vode na žlici.
English: How is Tracleer used?
Croatian: Kako djeluje Tracleer?
English: This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma.
Croatian: To se temelji na dvama ispitivanjima koja su obuhvaćala ukupno 245 odraslih osoba sa III.
English: Tracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Croatian: Na temelju dvaju ispitivanja provedenih na ukupno 312 odraslih osoba pokazalo se da je lijek Tracleer učinkovitiji od placeba u pogledu smanjenja nastanka novih digitalnih ulceracija.
English: For the full list of side effects Tracleer, see the package leaflet.
Croatian: Potpuni popis nuspojava povezanih s lijekom Tracleer potražite u uputi o lijeku.
English: • If you have any question or concern, speak with your doctor or pharmacist.
Croatian: • Ako imate pitanja ili ste zabrinuti, obratite se svom liječniku ili ljekarniku.
English: The review of adrenaline auto-injectors was initiated at the request of the United Kingdom in April 2014, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled automatskih brizgalica za adrenalin pokrenut je na zahtjev Ujedinjene Kraljevine u travnju 2014. u skladu sa člankom 31. Direktive 2001/83/EZ.
English: The CHMP concluded that training of the user is of paramount importance.
Croatian: CHMP je zaključio je obuka korisnika od najvećeg značaja.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 14/08/2015.
Croatian: Mišljenje CHMP-a dostavljeno je Europskoj Komisiji, koja je izdala konačnu pravno obvezujuću odluku primjenjivu u svim državama članicama EU dana 14/08/2015.
English: • It is likely that your doctor will recommend that you carry 2 injectors, in case a second dose is needed while you wait for emergency assistance.
Croatian: • Izgledno je da će Vam liječnik preporučiti nošenje 2 brizgalice, u slučaju da je potrebna druga doza dok čekate hitnu pomoć.
English: This supports the introduction of proper training and comprehensive educational material for patients and healthcare professionals.
Croatian: Ovo podržava uvođenje ispravne obuke i opsežnih edukacijskih materijala za bolesnike i zdravstvene djelatnike.
English: They are designed so that they can be easily used by the patient themselves or a carer.
Croatian: Dizajnirane su tako da su jednostavne za uporabu od strane bolesnika ili pružatelja skrbi.
English: • Several factors may affect whether adrenaline reaches the muscle layer.
Croatian: • Nekoliko čimbenika može utjecati na to hoće li adrenalin dosegnuti mišićni sloj.
English: A training device will also be developed so that you can practise with it before you need the autoinjector in an emergency.
Croatian: Uređaj za obuku bit će također razvijen kako biste mogli s njim vježbati prije nego što ćete morati primijeniti automatsku brizgalicu u hitnim slučajevima.
English: • It is important that you use the auto-injector correctly so that the adrenaline is delivered into your muscle and works as quickly as possible.
Croatian: • Važno je da ispravno koristite svoju automatsku brizgalicu tako da se adrenalin isporučuje u mišić i da djeluje što je brže moguće.
English: The CHMP recommendation was sent to the European Commission which endorsed it and issued a legally binding decision that is valid throughout the EU.
Croatian: Preporuka CHMP-a poslana je Europskoj Komisiji koja ju je potvrdila i izdala je pravno obvezujuću odluku koja je primjenjiva na razini EU.
English: • A study in 2013 by Brown et al. showed that 15% of the mothers were unable to use the autoinjector successfully in their children.
Croatian: • Ispitivanje u 2013. godini provedeno od strane Brown et al. pokazalo je da su majke mogle uspješno koristiti automatske brizgalice u svoje djece.
English: This followed a national review of all adrenaline autoinjector products approved in the UK, which concluded that there was no robust evidence that the devices deliver adrenaline into a muscle for all patients.
Croatian: Nakon toga slijedio je nacionalan pregled svih automatskih brizgalica za adrenalin odobrenih u UK, nakon čega je zaključeno kako ne postoje robusni dokazi da uređaji isporučuju adrenalin u mišić svih bolesnika.
English: On 25 June 2015, the European Medicines Agency (EMA) recommended several measures, including the introduction of more effective educational material, to ensure that patients and carers use adrenaline auto-injectors successfully.
Croatian: Dana 25. lipnja 2015., Europska agencija za lijekove (EMA) preporučila je nekoliko mjera, uključujući uvođenje djelotvornijih edukacijskih materijala, kako bi se osigurala uspješnija primjena automatskih brizgalica za adrenalin od strane bolesnika i pružatelja skrbi.
English: Adrenaline auto-injectors have been approved through national procedures in all the EU Member States.
Croatian: Automatske brizgalice za adrenalin odobrene su za primjenu putem nacionalnih postupaka unutar EU.
English: Contact our press officer Monika Benstetter
Croatian: Monika Benstetter Tel.
English: Anaphylaxis is a life-threatening reaction that causes a drop in blood pressure and breathing difficulties.
Croatian: Anafilaksa je po život opasna reakcija koja uzrokuje pad krvnog tlaka i otežano disanje.
English: • If you have been prescribed an adrenaline auto-injector because you are at risk of severe allergic reactions, you should ensure you are familiar with it and carry it with you at all times.
Croatian: • Ako Vam je propisana automatska brizgalica za adrenalin zato što ste izloženi riziku od ozbiljnih alergijskih reakcija, trebate osigurati da ste upoznati sa korištenjem brizgalice i da je nosite cijelo vrijeme sa sobom.
English: A training video will be produced to show you in detail how to use the injector properly.
Croatian: Snimit će se video za obuku kako bi Vas se detaljno prikazala ispravna primjena brizgalice.
English: This includes a training device with which patients can practise; audio-visual material to show in detail how the device is to be used; and a checklist for prescribers to ensure that sufficient information is given to the patient before they use the auto-injector.
Croatian: Ovo uključuje uređaje za obuku s kojima bolesnici mogu vježbati; audio-vizualne materijale koji detaljno prikazuju primjenu uređaja; i kontrolni popis za propisivače kako bi se osiguralo da će bolesnici primiti dovoljnu količinu informacija prije primjene automatske brizgalice.
English: The CHMP also concluded that further data should be generated to better understand how adrenaline penetrates body tissues when given with each of the different auto-injectors.
Croatian: CHMP je također zaključio da se daljnji podaci trebaju generirati kako bi se dobilo bolje razumijevanje o načinu penetriranja adrenalina u tkivo tijela ako se primjenjuje različitim automatskim brizgalicama.
English: An injection of adrenaline helps to relieve the symptoms of anaphylaxis quickly by narrowing the blood vessels (thereby increasing the blood pressure) and opening up the airways to help with the breathing.
Croatian: Injekcija adrenalina pomaže pri brzom ublažavanju simptoma anafilakse tako što sužava krvne žile (time se ujedno povećava krvni tlak) i otvara zračne putove kako bi se olakšalo disanje.
English: The companies that market adrenaline auto-injectors have therefore been asked to develop more effective educational material for patients, as well as for healthcare professionals, to ensure their optimal use.
Croatian: Stoga je od tvrtki koje stavljaju automatske brizgalice adrenalina na tržište zatraženo da razviju djelotvornije edukacijske materijale za bolesnike kao i za zdravstvene djelatnike sa ciljem osiguravanja optimalne uporabe.
English: EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.
Croatian: EMA je provela pregled automatskih brizgalica adrenalina nakon iznijete zabrinutosti da trenutno dostupni uređaju isporučuju adrenalin ispod kože umjesto u mišić, te da se na ovaj način odgađa odgovor na terapiju.
English: • Your family members, carers or teachers should also be instructed in the correct use of the autoinjector.
Croatian: • Vaši članovi obitelji, pružatelji skrbi i učitelji trebaju također proći obuku o ispravnoj primjeni automatske brizgalice.
English: This will include a training device that patients can practise with, audiovisual material and a prescriber checklist.
Croatian: Isti će uključivati uređaj za obuku s kojima bolesnici mogu vježbati, audio-vizualne materijale i kontrolni popis propisivača.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's final opinion.
Croatian: Pregled je proveo Odbor za lijekove za primjenu u ljudi (CHMP), odgovoran za pitanja vezana uz lijekove za primjenu u ljudi.
English: However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.
Croatian: No, CHMP je zaključio kako nekoliko čimbenika može utjecati na to isporučuje li se adrenalin stvarno u mišić; ovi čimbenici uključuju dužinu igle, debljinu masnog tkiva ispod kože, način na koji automatska brizgalica djeluje (primjerice ako se puni oprugom ili ne), kut pod kojim se uređaj stavlja na kožu i sila koja se koristi za aktiviranje uređaja kao i mjera u kojoj se korisnik pridržava upute za injekciju.
English: Having assessed all the available data, EMA's Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis.
Croatian: Nakon što je ocijenio sve dostupne podatke, Odbor za lijekove za primjenu u ljudi (CHMP) potvrdio je primjenu lijeka u mišić kao preferirani način dobivanja brzog odgovora u slučaju anafilakse.
English: • Educational material will be developed to ensure that patients or carers use adrenaline autoinjectors successfully.
Croatian: • Bit će razvijeni edukacijski materijali kako bi se osiguralo da će bolesnici ili pružatelji skrbi uspješno koristiti automatske brizgalice za adrenalin.
English: Training device and audio-visual material expected to promote appropriate use of auto-injectors
Croatian: Uređaji za obuku i audio-vizualni materijali za koje se očekuju da unaprijede primjerenu primjenu automatskih brizgalica
English: The product information of adrenaline auto-injectors has also been updated with further warnings and precautions, including a recommendation that patients should be prescribed two auto-injectors which they should carry at all times and a recommendation for family members, carers or teachers to be trained on how to use the auto-injector.
Croatian: Informacije o lijeku za automatske brizgalice adrenalina također su ažurirane daljnjim upozorenjima i mjerama opreza, uključujući i preporuke da se bolesnicima trebaju propisati dvije automatske brizgalice koje trebaju nositi sa sobom cijelo vrijeme te preporuka za obuku o načinu prijeme automatskih brizgalica za članove obitelji, pružatelje skrbi ili učitelje.
English: • The companies that market adrenaline auto-injectors have been asked to carry out a pharmacokinetic/pharmacodynamic study to better understand how adrenaline penetrates body tissues when given through an auto-injector.
Croatian: • Od tvrtke koja stavlja automatske brizgalice za adrenalin u promet zatraženo je da provede farmakokinetičko/farmakodinamičko ispitivanje kako bi se bolje razumio način na koji adrenalin penetrira u tkiva tijela ako se primjenjuje automatskom brizgalicom.
English: • Because of the uncertainties over drug delivery from adrenaline auto-injectors and the consequent uncertainties around the onset of pharmacodynamic response, it is recommended that healthcare professionals prescribe 2 auto-injectors, which patients should carry at all times.
Croatian: • Budući da postoje nesigurnosti vezane uz isporuku lijeka iz automatske brizgalice za adrenalin te učestale nesigurnosti vezane uz nastupanje farmakodinamičkog odgovora, preporuča se da zdravstveni djelatnici propišu 2 automatske brizgalice, koje bolesnici mogu nositi u svakom trenutku sa sobom.
English: These include: needle length, the skin-to-muscle depth, the way the auto-injector works (e.g. if it is spring loaded or not), the angle of placement on the skin and the force used to activate the device.
Croatian: Ovi čimbenici uključuju: dužinu igle, debljinu masnog tkiva ispod kože, način na koji automatska brizgalica djeluje (primjerice ako se puni oprugom ili ne), kut pod kojim se uređaj stavlja na kožu i sila koja se koristi za aktiviranje uređaja.
English: Adrenaline (epinephrine) auto-injectors are given to people who are at risk of anaphylaxis (severe allergic reaction) or have had a previous episode of anaphylaxis, to use as a first-aid measure in case of emergencies while waiting for emergency medical assistance.
Croatian: Automatske brizgalice za adrenalin (epinefrin) primjenjuju se u osoba koje su izložene riziku od anafilakse (ozbiljne alargijske reakcije) ili koje su već imale epizode anafilakse kao prva mjera pomoći u hitnim slučajevima dok čekaju dolazak hitne medicinske pomoći.
English: • The review of adrenaline auto-injectors confirmed that intramuscular injection is the preferred route of administration in the treatment of anaphylaxis in order to obtain a rapid response.
Croatian: • Pregledom automatskih brizgalica za adrenalin potvrđena je intramuskularna injekcija kao preferirani put primjene u terapiji anafilakse kako bi se dobio brzi odgovor.
English: • Adrenaline auto-injectors are used to treat severe allergic reactions, while the patient awaits emergency medical assistance.
Croatian: • Automatske brizgalice za adrenalin koriste se za uspješnu terapiju alergijskih reakcija, dok bolesnici čekaju hitnu medicinsku pomoć.
English: Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.
Croatian: Automatske brizgalice za adrenalin mogu potencijalno spasiti život u slučaju terapije anafilakse (ozbiljnih alergijskih reakcija) dok bolesnici čekaju hitnu medicinsku pomoć.
English: • The review of adrenaline auto-injectors showed that patients could benefit from further training to use the auto-injector successfully.
Croatian: • Pregledom automatskih brizgalica za adrenalin utvrđeno je da bolesnici mogu imati koristi od daljnje obuke o uspješnom načinu primjene automatskih brizgalica.
English: Comparison of Needle Penetration Depth Probabilities of Two Epinephrine Auto-Injectors.
Croatian: Wang, C., R. Wolf, et al. (2013.) Comparison of Needle Penetration Depth Probabilities of Two Epinephrine Auto-Injectors.
English: "Epinephrine absorption in adults: intramuscular versus subcutaneous injection."
Croatian: Simons, F. E., X. Gu, et al. (2001.) "Epinephrine absorption in adults: intramuscular versus subcutaneous injection."
English: Simons, F. E., J. R. Roberts, et al. (1998).
Croatian: Simons, F. E., J. R. Roberts, et al. (1998.) "Epinephrine absorption in children with a history of anaphylaxis."
English: • You will receive training from your doctor or nurse on how to use your adrenaline auto-injector.
Croatian: • Obuku o načinu primjene automatske brizgalice za adrenalin primit ćete od svojeg liječnika ili medicinske sestre.
English: "Adequacy of the epinephrine autoinjector needle length in delivering epinephrine to the intramuscular tissues."
Croatian: Song, T. T., M. R. Nelson, et al. (2005.) "Adequacy of the epinephrine auto-injector needle length in delivering epinephrine to the intramuscular tissues."
English: "Predictors of epinephrine autoinjector needle length inadequacy."
Croatian: Bhalla, M. C., B. D. Gable, et al. (2013.) "Predictors of epinephrine autoinjector needle length inadequacy."
English: Brown, J., D. Tuthill, et al. (2013).
Croatian: Brown, J., D. Tuthill, et al. (2013.) "A randomized maternal evaluation of epinephrine autoinjection devices."
English: After first opening: 60 days.
Croatian: Nakon prvog otvaranja: 60 dana.
English: Date of first authorisation: 09 February 2018
Croatian: Datum prvog odobrenja: 09. veljače 2018
English: If your child becomes unwell
Croatian: Ako Vašem djetetu bude loše
English: 50 capsules
Croatian: 50 kapsula
English: Alkindi with food and drink
Croatian: Alkindi s hranom i pićem
English: Read all of this leaflet carefully before you start giving this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete davati ovaj lijek jer sadrži Vama važne podatke.
English: 68.8% of healthy adult volunteers have described the taste as neutral.
Croatian: U skupini zdravih odraslih dobrovoljaca, 68,8 % opisalo je okus kao neutralan.
English: The lowest possible dosage should be used.
Croatian: Treba primjenjivati najnižu moguću dozu.
English: During stress it may be necessary to increase the dose temporarily.
Croatian: Za vrijeme stresa možda će biti potrebno privremeno povećati dozu.
English: ATC code: H02AB09
Croatian: ATK oznaka: H02AB09
English: Infections and immunisation
Croatian: Infekcije i imunizacija
English: Indigotine (E132)
Croatian: Indigotin (E132)
English: Each carton contains 1 bottle.
Croatian: Svaka kutija sadrži jednu bocu.
English: Symptoms typically emerge within a few days or weeks of starting the treatment.
Croatian: Simptomi se uglavnom javljaju unutar nekoliko dana ili tjedana od početka liječenja.
English: The biological half-life of hydrocortisone is about 100 minutes.
Croatian: Biološki poluvijek hidrokortizona je otprilike 100 minuta.
English: Six of the 12 children in Cohort 1 (age range 2.6 to 4.7 years) responded to an adjusted palatability questionnaire.
Croatian: Šestoro od 12 djece u prvoj kohorti (u dobi od 2,6 do 4,7 godina) odgovorilo je na prilagođeni upitnik o palatabilnosti.
English: Adrenal crisis
Croatian: Adrenalna kriza
English: In situations when the body is exposed to excessive physical and/or mental stress, patients may need an increased dose, especially in the afternoon or evening.
Croatian: U situacijama kada je tijelo izloženo prekomjernom tjelesnom i/ili mentalnom stresu, bolesnicima može trebati povećana doza, osobito poslijepodne ili uvečer.
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, including those which can be obtained without a prescription.
Croatian: Obavijestite svojeg liječnika ili ljekarnika ako Vaše dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove, uključujući one koji se mogu nabaviti bez recepta.
English: Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 France
Croatian: Delpharm Lille SAS Parc d'Activités Roubaix-Est 22 rue de Toufflers CS 50070 Lys Lez Lannoy, 59 452 Francuska
English: They are also used for their potent anti-inflammatory effects in disorders of many organ systems.
Croatian: Upotrebljavaju se također zbog svojih snažnih protuupalnih učinaka pri poremećajima mnogih organskih sustava.
English: What Alkindi is and what it is used for
Croatian: Što je Alkindi i za što se koristi
English: Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Croatian: Nadomjesna terapija za liječenje adrenalne insuficijencije u dojenčadi, djece i adolescenata (od rođenja do < 18 godina starosti).