FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not intended to provide practical advice on how to use Revestive.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Revestive.
English: Because the number of patients with the condition is low, the disease is considered ‘rare', and Revestive was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Croatian: Budući da je broj bolesnika s ovom bolešću nizak, ta se bolest smatra „rijetkom” te je Revestive dobio status „lijeka za liječenje rijetkih bolesti” 11. prosinca 2001.
English: The recommended dose is 0.05 mg per kilogram body weight once a day, with the daily dose reduced by half in patients with moderate or severely reduced kidney function.
Croatian: Preporučena doza je 0,05 mg po kilogramu tjelesne težine jednom dnevno, pri čemu je dnevna doza prepolovljena u bolesnika s umjereno ili teže ograničenom funkcijom bubrega.
English: The most commonly reported side effects with Revestive (which may occur in more than 1 in 10 patients) were respiratory tract infections (infections of the throat, sinuses, airways or lungs), headache, belly ache and swollen stomach, nausea, vomiting, and reddening, pain or swelling at the site of the injection.
Croatian: Najčešće prijavljene nuspojave lijeka Revestive (koje se mogu javiti u više od 1 na 10 bolesnika) bile su infekcije dišnih puteva (infekcije grla, sinusa, dišnih putova ili pluća), glavobolja, bol u trbuhu i natečen trbuh, mučnina, povraćanje te crvenilo, bol ili oticanje na mjestu injektiranja.
English: Why is Revestive approved?
Croatian: Zašto je lijek Revestive odobren?
English: This compares with 30% (13 out of 43) of those given placebo (a dummy treatment).
Croatian: U usporedbi, ti su rezultati zabilježeni u 30 % (13 od 43) bolesnika koji su primili placebo (prividno liječenje).
English: Teduglutide has the advantage of lasting longer than GLP-2 in the body.
Croatian: Teduglutid ima prednost da u organizmu djeluje duže nego GLP-2.
English: What are the risks associated with Revestive?
Croatian: Koji su rizici povezani s lijekom Revestive?
English: Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above.
Croatian: Revestive je lijek za liječenje sindroma kratkog crijeva u odraslih i djece u dobi od godinu dana i starije.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revestive have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Revestive nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In addition, patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine) commonly experienced complications, such as swelling of the stoma.
Croatian: Nadalje, bolesnici sa stomom (umjetnim otvorom s prednje strane abdomena za pražnjenje fekalija ili urina) često su imali komplikacije poput oticanja stome.
English: In a second study in children, 53% (8 out of 15) of those who received Revestive had their parenteral nutrition at 12 weeks reduced by at least a tenth, while none (0 out of 5) of the patients who received a standard treatment achieved the same.
Croatian: U drugom ispitivanju u djece, u 53 % (8 od 15) osoba koje su primile Revestive količina parenteralne prehrane smanjena je u 12. tjednu za barem desetinu, dok taj rezultat nije postignut ni kod jednog bolesnika (0 od 5) koji su primili standardnu terapiju.
English: Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition).
Croatian: Bolesnici sa sindromom kratkog crijeva obično primaju hranjive tvari u obliku infuzije izravno u venu (parenteralna prehrana).
English: Revestive contains the active substance teduglutide.
Croatian: Revestive sadrži djelatnu tvar teduglutid.
English: In one study in adults, 63% (27 out of 43) of those who received Revestive had their parenteral nutrition at 20 weeks reduced by at least a fifth and maintained this reduced intake at 24 weeks.
Croatian: U jednom ispitivanju u odraslih, u 63 % (27 od 43) osoba koje su primile Revestive količina parenteralne prehrane u 20. tjednu bila je smanjena za petinu, što je održano do 24. tjedna.
English: Revestive must not be used in patients who have, or are suspected to have, cancer.
Croatian: Revestive se ne smije koristiti u bolesnika koji imaju rak ili kod postoji sumnja na njega.
English: Revestive has been shown in 2 studies to reduce the amount of parenteral nutrition that patients need.
Croatian: U dva se ispitivanja pokazalo da Revestive smanjuje količinu parenteralne prehrane potrebne bolesnicima.
English: For more information about treatment with Revestive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Revestive pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP-2), a hormone made in the gut that increases absorption of nutrients from the intestine.
Croatian: Djelatna tvar lijeka Revestive, teduglutid, peptid je sličan ljudskom glukagonu 2 (GLP-2), hormonu koji proizvodi crijevo, te koji pospješuje apsorpciju hranjivih tvari iz crijeva.
English: Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine.
Croatian: Teduglutid djeluje na sličan način kao i GLP-2, pospješujući crijevnu apsorpciju povećanjem protoka krvi kroz crijevo, smanjenjem brzine kojom hrana prolazi kroz njega te smanjivanjem izlučivanja kiseline u želudcu što može ometati apsorpciju u crijevima.
English: Studies show that Revestive is beneficial for patients with short bowel syndrome as it significantly reduces the amount of parenteral nutrition they need.
Croatian: Ispitivanja su pokazala da je Revestive bio koristan bolesnicima sa sindromom kratkog crijeva jer im je značajno smanjio količinu potrebne parenteralne prehrane.
English: For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Revestive bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: How does Revestive work?
Croatian: Kako djeluje Revestive?
English: What benefits of Revestive have been shown in studies?
Croatian: Koje su koristi lijeka Revestive utvrđene u ispitivanjima?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Revestive nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Ovaj sažetak je posljednji put ažuriran u 05. 2017.
English: How is Revestive used?
Croatian: Kako se Revestive koristi?
English: Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
Croatian: Sindrom kratkog crijeva je poremećaj koji je posljedica nemogućnosti apsorpcije hranjivih tvari i tekućine iz crijeva jer je veliki dio crijeva kirurški uklonjen.
English: For the full list of all side effects reported with Revestive, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Revestive potražite u uputi o lijeku.
English: The educational materials should ensure that healthcare professionals and patients/carers are able to successfully administer the product based on the instructions in the product information.
Croatian: Edukacijski materijali trebaju osigurati da zdravstveni djelatnici i bolesnici/pružatelji skrbi mogu uspješno primjenjivati proizvod na temelju uputa u informacijama o proizvodu.
English: The protocol shall be submitted to the National Competent Authorities:
Croatian: Protokol treba dostaviti nacionalnim nadležnim tijelima:
English: Each Marketing Authorisation Holder of adrenaline auto-injectors shall perform a PK/PD study to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via their adrenaline auto-injector device.
Croatian: Svaki nositelj odobrenja za stavljanje u promet automatske brizgalice za adrenalin provest će PK/PD ispitivanje kako bi razumio utjecaj različitih čimbenika za distribuciju, izlaganje i aktivnost adrenalina kada se primjenjuje putem automatske brizgalice za adrenalin.
English: The Marketing Authorisation Holders of adrenaline auto-injectors shall submit to the National Competent Authorities a Risk Management Plan containing key elements as described in the CHMP assessment report (including educational materials).
Croatian: Nositelji odobrenja za stavljanje lijeka u promet za automatske brizgalice za adrenalin dostavit će nacionalnim nadležnim tijelima plan upravljanja rizikom koji sadrži ključne elemente opisane u izvješću ocjene CHMP-a (uključujući edukacijske materijale).
English: National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Croatian: Nacionalna nadležna tijela države članice (država članica) ili referentne države članice (referentnih država članica), ako je primjenjivo, trebaju osigurati da nositelj(i) odobrenja ispune sljedeće uvjete:
English: The final study report shall be submitted to the National Competent Authorities:
Croatian: završno izvješće ispitivanja treba dostaviti nacionalnim nadležnim tijelima:
English: Annex IV Conditions to the marketing authorisation
Croatian: Prilog IV. Uvjeti odobrenja za stavljanje lijeka u promet
English: Moreover, the intended use does not require medical supervision.
Croatian: Štoviše, predviđena uporaba ne zahtijeva liječnički nadzor.
English: Chicory root should only be used in adults and children over the age of 12 years.
Croatian: Vodopijin korijen smije se koristiti samo u odraslih i djece starije od 12 godina.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Croatian: To znači da iako nema dovoljno dokaza iz kliničkih ispitivanja, učinkovitost ovih biljnih lijekova je vjerojatna te postoji dokaz o njihovoj sigurnoj uporabi na ovaj način tijekom najmanje 30 godina (uključujući najmanje 15 godina na području EU).
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Croatian: U vrijeme ocjene od strane HMPC-a, nije bilo prijavljenih nuspojava s ovim lijekovima.
English: EMA/HMPC/286842/2013
Croatian: Vodopijin korijen EMA/HMPC/286842/2013
English: This summary is not intended to provide practical advice on how to use medicines containing chicory root.
Croatian: Svrha ovog sažetka nije pružanje praktičnih savjeta o načinu uporabe lijekova koji sadrže vodopijin korijen.
English: What is chicory root?
Croatian: Što je vodopijin korijen?
English: Further information on the HMPC assessment of chicory root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Dodatne informacije o HMPC-ovoj ocjeni lijekova koji sadrže vodopijin korijen, uključujući pojedinosti zaključaka Povjerenstva, mogu se pronaći u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with chicory root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Croatian: Više informacija o rizicima povezanim s lijekovima koji sadrže vodopijin korijen, uključujući odgovarajuće mjere opreza za njihovu sigurnu uporabu, možete pronaći u monografiji u rubrici 'All documents' na internetskoj stranici Agencije: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Any applications for the licensing of medicines containing chicory root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Croatian: Svi zahtjevi za odobrenje lijekova koji sadrže vodopijin korijen moraju se podnijeti nacionalnim tijelima nadležnim za lijekove, koja ocjenjuju zahtjev za biljni lijek i uzimaju u obzir znanstvene zaključke HMPC-a.
English: In addition, the HMPC considered that chicory rood contains bitter substances that may stimulate appetite and also a study in the laboratory, which showed an effect of chicory root in stimulating an increased secretion of bile (a fluid produced in the liver that helps to break down fats), thereby supporting its use in digestive disorders.
Croatian: Osim toga, HMPC je uzeo u obzir da vodopijin korijen sadrži gorke tvari koje bi mogle potaknuti apetit te također studiju u laboratoriju koja je pokazala učinak vodopijinog korijena u stimulaciji povećanog izlučivanja žuči (tekućine koju stvara jetra i koja pomaže u razgradnji masnoća) te stoga podržava njegovu uporabu u probavnim poremećajima.
English: Information on the use and licensing of chicory root medicines in EU Member States should be obtained from the relevant national authorities.
Croatian: Informacije o uporabi i odobrenju za lijekove koji sadrže vodopijin korijen u državama članicama Europske unije mogu se dobiti od nadležnih nacionalnih tijela.
English: Chicory root can also be found in combination with other herbal substances in some herbal medicines.
Croatian: Vodopijin korijen prisutan je također i u kombinaciji s drugim biljnim tvarima u određenim biljnim lijekovima.
English: The HMPC conclusions on the use of chicory root medicines for the relief of symptoms of mild digestive disorders and temporary loss of appetite are based on their ‘traditional use'.
Croatian: Zaključci HMPC-a o uporabi lijekova koji sadrže vodopijin korijen za ublažavanje simptoma blagih probavnih poremećaja i privremenog gubitka apetita temelje se na njihovoj "tradicionalnoj uporabi".
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of chicory root.
Croatian: Ovaj dokument predstavlja sažetak znanstvenih zaključaka Povjerenstva za biljne lijekove (HMPC) u pogledu medicinske uporabe vodopijinog korijena.
English: A doctor should be consulted if the symptoms persist following 2 weeks of treatment.
Croatian: Ako se simptomi ne povuku nakon dva tjedna liječenja, potrebno je savjetovati se s liječnikom.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing chicory root.
Croatian: Države članice Europske unije uzimaju u obzir zaključke HMPC-a prilikom ocjenjivanja zahtjeva za odobrenje biljnih lijekova koji sadrže vodopijin korijen.
English: In its assessment, the HMPC took into account the well documented use of chicory root in digestive disorders and loss of appetite.
Croatian: HMPC je prilikom ocjene uzeo u obzir dobro dokumentiranu uporabu vodopijinog korijena u probavnim poremećajima i gubitku apetita.
English: The HMPC concluded that, on the basis of its long-standing use, chicory root can be used for the relief of symptoms of mild digestive disorders (such as feeling full, flatulence and slow digestion) and temporary loss of appetite.
Croatian: HMPC je zaključio da se, na temelju njegove dugogodišnje uporabe, vodopijin korijen može koristiti za ublažavanje simptoma blagih probavnih poremećaja (poput osjećaja punoće, vjetrova i spore probave) i privremenog gubitka apetita.
English: Other information about chicory root medicines
Croatian: Ostale informacije o lijekovima koji sadrže vodopijin korijen
English: Detailed instruction on how to take chicory root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: Detaljne upute o tome kako uzimati lijekove koji sadrže vodopijin korijen i tko ih može uzimati dostupne su u uputi o lijeku koja je priložena uz lijek.
English: Herbal medicines containing chicory root are usually available as herbal tea to be drunk.
Croatian: Biljni lijekovi koji sadrže vodopijin korijen obično su dostupni u obliku biljnih čajeva koji se piju.
English: What are the risks associated with chicory root medicines?
Croatian: Koji su rizici povezani s lijekovima koji sadrže vodopijin korijen?
English: For more information about treatment with chicory root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekovima koji sadrže vodopijin korijen pročitajte u uputi o lijeku priloženoj uz lijek odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using chicory root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o uporabi lijekova koji sadrže vodopijin korijen bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: What evidence supports the use of chicory root medicines?
Croatian: Koji dokazi potkrjepljuju uporabu lijekova koji sadrže vodopijin korijen?
English: Chicory root is the common name for the root of the plant Cichorium intybus L. The plant is cultivated or gathered to obtain the root for medicinal use.
Croatian: Vodopijin korijen je uobičajeni naziv za korijen biljke Cichorium intybus L.
English: Chicory root
Croatian: Vodopijin korijen
English: Chicory root preparations are obtained by comminuting the roots (reducing them into tiny pieces).
Croatian: Pripravci vodopijinog korijena dobivaju se usitnjavanjem korijena.
English: How are chicory root medicines approved in the EU?
Croatian: Kako se u Europskoj uniji odobravaju lijekovi koji sadrže vodopijin korijen?
English: Committee on Herbal Medicinal Products (HMPC)
Croatian: EMA/HMPC/286842/2013 Povjerenstvo za biljne lijekove (HMPC)
English: 15 months
Croatian: 15 mjeseci
English: Very rare, not known
Croatian: Vrlo rijetko, nepoznato
English: It may be given with or without food.
Croatian: Može se uzeti s hranom ili bez nje.
English: You should take your medicine at the same time each day.
Croatian: Lijek treba uzeti u isto vrijeme svaki dan.
English: • if you are in your last trimester of pregnancy.
Croatian: • ako ste u zadnjem tromjesečju trudnoće.
English: This leaflet was last revised in {MM/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u {MM/ GGGG}
English: Contact your doctor immediately if you experience:
Croatian: Odmah kontaktirajte svog liječnika ako primijetite:
English: Thus, the results from this subset are in line with the overall trial results.
Croatian: Prema tome, rezultati ove podskupine su u skladu s cjelokupnim rezultatima ispitivanja.
English: These may be the signs of an allergic reaction.
Croatian: Ti simptomi mogu biti znakovi alergijske reakcije.
English: In addition, due to the presence of ASA, its use is also contraindicated in:
Croatian: Dodatno, zbog prisutnosti ASK, njegova je primjena također kontraindicirana:
English: Rhone 69800, France
Croatian: Rhone 69800, Francuska
English: Cmax occurs approximately 30 to 60 minutes after dosing.
Croatian: Cmax se postiže otprilike 30 do 60 minuta nakon primjene.
English: The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%.
Croatian: Apsolutni rizik razvoja srčanih malformacija povećao se s manje od 1% na otprilike 1,5%.
English: • Third trimester of pregnancy (see section 4.6).
Croatian: • u trećem tromjesečju trudnoće (vidjeti dio 4.6).
English: Therefore, such addition should be undertaken with caution outside of clinical situations where the combination has proven to be beneficial.
Croatian: Stoga se ta kombinacija mora uzimati s oprezom izvan kliničkih situacija u kojima se kombinacija pokazala korisnom.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako su Vam je rekao liječnik ili ljekarnik.
English: Medicinal products associated with bleeding risk
Croatian: Lijekovi povezani s rizikom od krvarenja
English: Gastrointestinal (GI)
Croatian: Gastrointestinalni sustav (GI)
English: If you have had a heart attack, it should be prescribed for at least four weeks.
Croatian: Ako ste imali srčani udar, terapija bi trebala trajati najmanje 4 tjedna.
English: The risk is believed to increase with dose and duration of therapy.
Croatian: Vjeruje se da rizik raste s povećanjem doze i trajanjem terapije.
English: In any case, you should take it for as long as your doctor continues to prescribe it.
Croatian: U svakom slučaju lijek trebate uzimati sve dok Vam ga liječnik propisuje.
English: The clinical relevance of this interaction is uncertain.
Croatian: Klinička važnost ove interakcije je nejasna.
English: The clinical relevance is unknown.
Croatian: Klinički značaj je nepoznat.
English: Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Croatian: Nadalje, sigurnosni profil klopidogrela u toj podskupini bolesnika nije potaknuo nikakvu posebnu zabrinutost.
English: 117 Allée des Parcs, 69 800 Saint Priest, France
Croatian: 117 Allée des Parcs, 69 800 Saint Priest, Francuska
English: Biotransformation and Elimination
Croatian: Biotransformacija i eliminacija
English: Anti-retroviral therapies (ART)
Croatian: Antiretrovirusna terapija (ART)
English: • Your doctor may order blood tests.
Croatian: • Vaš liječnik će možda odrediti pretrage krvi.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Croatian: TTP je potencijalno smrtonosno stanje koje zahtijeva hitno liječenje uključujući i plazmaferezu.
English: In addition, your doctor may identify changes in your blood or urine tests.
Croatian: Dodatno, Vaš liječnik može naći promjene u rezultatima pretraga krvi ili urina.
English: At low concentrations (<100 micrograms/ml), approximately 90% of salicylic acid is bound to albumin.
Croatian: Pri niskim koncentracijama (< 100 µg/ml), otprilike 90% salicilatne kiseline vezano je za albumin.
English: It is preferable not to take this medicine during first and second trimesters of pregnancy.
Croatian: Ne preporučuje se uzimanje ovog lijeka u prvom i drugom tromjesečju trudnoće.
English: These may be due to rare decrease of some blood cells.
Croatian: Ti simptomi mogu biti posljedica rijetkog smanjenja broja nekih krvnih stanica;
English: There is an increased risk of bleeding due to the potential additive effect.
Croatian: Povećan je rizik od krvarenja zbog mogućeg aditivnog učinka.
English: It is recommended that patients not be given salicylates for an interval of six weeks after receiving the varicella vaccine.
Croatian: Preporučuje se da se bolesnicima ne daju salicilati u razdoblju od šest tjedana nakon primanja cjepiva protiv varičela.
English: If a toxic dose has been ingested then admission to hospital is necessary.
Croatian: Ako je uzeta toksična doza, neophodna je hospitalizacija.
English: Initial hyperventilation leads to respiratory alkalosis.
Croatian: Inicijalna hiperventilacija dovodi do respiratorne alkaloze.