FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Oxervate (which may affect more than 1 in 100 people) are eye pain and inflammation, increased lacrimation (watery eyes), pain in the eyelid and sensation of a foreign body in the eye.
Croatian: Najčešće nuspojave lijeka Oxervate (koje se mogu javiti u više od 1 na 100 osoba) jesu bol u oku i upala oka, pojačana lakrimacija (suzenje očiju), bol u očnom kapku i osjećaj da se u oku nalazi strano tijelo.
English: In the first study, 74% (37 out of 50) of patients treated with Oxervate for 8 weeks achieved complete healing of the eye's surface compared with 43% (22 out of 51) of patients treated with a dummy treatment containing the same eye drop formula but no active substance.
Croatian: U prvom ispitivanju u 74 % bolesnika (37 od 50) koji su primali lijek Oxervate tijekom 8 tjedana postiglo se potpuno zacjeljivanje površine oka u usporedbi s 43 % bolesnika (22 od 51) koji su primali lažni lijek koji je sadržavao istu formulu kapi za oči, ali bez djelatne tvari.
English: Why is Oxervate approved?
Croatian: Zašto je lijek Oxervate odobren?
English: The full EPAR for Oxervate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni (EPAR) lijeka Oxervate nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oxervate have 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 Oxervate nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Because the number of patients with neurotrophic keratitis is low, the disease is considered ‘rare', and Oxervate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 December
Croatian: Budući da je broj bolesnika s neurotrofnim keratitisom malen, ta se bolest smatra „rijetkom” te se lijek Oxervate označava kao „lijek za rijetku bolest” od 14. prosinca 2015.
English: Oxervate has been shown to help heal damage to the eye's surface in 2 main studies involving a total of 204 adults with moderate or severe neurotrophic keratitis.
Croatian: Oxervate je dokazano pridonio zacjeljivanju oštećenja površine oka u dvama glavnim ispitivanjima u kojima su sudjelovale 204 odrasle osobe s umjerenim ili teškim simptomima neurotrofnog keratitisa.
English: In the second study, figures were 70% (16 out of 23) with Oxervate and 29% (7 out of 24) with the dummy treatment.
Croatian: U drugom ispitivanju te su vrijednosti bile 70 % (16 od 23 bolesnika) u skupini koja je primala lijek Oxervate, odnosno 29 % (7 od 24 bolesnika) u skupini koja je sudjelovala u prividnom liječenju.
English: For more information about treatment with Oxervate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Oxervate pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svojem liječniku ili ljekarniku.
English: Oxervate can only be obtained with a prescription and treatment should be started and supervised by an eye specialist.
Croatian: Oxervate se izdaje samo na recept, a liječenje treba započeti i nadzirati liječnik specijalist za bolesti oka.
English: What benefits of Oxervate have been shown in studies?
Croatian: Koje su koristi lijeka Oxervate dokazane u ispitivanjima?
English: Patients with neurotrophic keratitis have lower than normal levels of substances including growth factors that are normally supplied by the trigeminal nerve and which play an important role in the growth and survival of the cells of the eye's surface.
Croatian: U bolesnika s neurotrofnim keratitisom razine nekih tvari niže su od uobičajenih, uključujući faktore rasta koji se obično opskrbljuju trigeminalnim živcem i koji su važni za rast i preživljavanje stanica površine oka.
English: Oxervate contains the active substance cenegermin.
Croatian: Lijek Oxervate sadržava djelatnu tvar cenegermin.
English: Side effects with Oxervate are mainly related to the eye, are mild or moderate in severity and resolve over time.
Croatian: Nuspojave povezane s lijekom Oxervate uglavnom su povezane s očima, blage su ili umjerene i prolaze s vremenom.
English: For practical information about using Oxervate, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Oxervate bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How does Oxervate work?
Croatian: Kako djeluje Oxervate?
English: Oxervate has been shown to increase by around 30-40% the number of patients who achieve complete healing of the eye's surface when compared with eye drops containing no active substance.
Croatian: Dokazano je da se zahvaljujući lijeku Oxervate broj bolesnika u kojih dolazi do potpunog zacjeljivanja površine oka povećao za 30 - 40 % u usporedbi s kapima za oči koje ne sadržavaju djelatnu tvar.
English: Oxervate is a medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally.
Croatian: Oxervate je lijek koji se primjenjuje za liječenje neurotrofnog keratitisa, oboljenja oka pri kojemu oštećenje trigeminalnog živca koji opskrbljuje površinu oka prouzročuje gubitak osjeta i oštećenja koja ne zacjeljuju prirodnim putem.
English: When given as eye drops to patients with neurotrophic keratitis, cenegermin helps restore some of the normal healing processes in the eye and repair damage to the eye's surface associated with the condition.
Croatian: Kad se cenegermin daje bolesnicima s neurotrofnim keratitisom u obliku kapi za oči, on pomaže obnoviti uobičajene procese zacjeljivanja oka i popraviti oštećenja površine oka povezana s tim oboljenjem.
English: The active substance in Oxervate, cenegermin, is a copy of a human growth factor called nerve growth factor.
Croatian: Djelatna tvar lijeka Oxervate, cenegermin, kopija je faktora rasta u ljudi koji se naziva faktor rasta živčanog sustava.
English: For the full list of all side effects and restrictions with Oxervate, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Oxervate potražite u uputi o lijeku.
English: Oxervate is available as eye drops.
Croatian: Lijek Oxervate dostupan je u obliku kapi za oči.
English: How is Oxervate used?
Croatian: Kako se Oxervate koristi?
English: Other information about Oxervate
Croatian: Ostale informacije o lijeku Oxervate
English: This summary was last updated in 07-2017.
Croatian: Oxervate EMA/330858/2017
English: These symptoms may vary from person to person.
Croatian: Ovi simptomi mogu varirati od osobe do osobe.
English: - The other ingredients are :
Croatian: - Drugi sastojci su:
English: Just take the next dose at the scheduled time and continue as normal.
Croatian: Samo uzmite sljedeću dozu u predviđeno vrijeme i nastavite dalje prema planu.
English: Physicians should periodically assess the need for continued treatment.
Croatian: Liječnici moraju periodično procjenjivati potrebu za kontinuiranim liječenjem.
English: For age related information, please see sections 4.2., 4.4., and 4.8.
Croatian: Za informaciju vezanu uz dob, molimo pogledati dijelove 4.2., 4.4. i 4.8.
English: If you take more Constella than you should
Croatian: Ako uzmete više Constelle nego što ste trebali
English: Keep the canisters in the bottle.
Croatian: Držite spremnike u boci.
English: Unopened bottle for 10 capsules: 2 years.
Croatian: Neotvorena boca s 10 kapsula: 2 godine.
English: However, treatment with Constella can be safely stopped at any time.
Croatian: Međutim, liječenje Constellom može se na siguran način prekinuti u bilo koje vrijeme.
English: Constella with food
Croatian: Constella s hranom
English: • feeling lightheaded after standing up quickly
Croatian: • osjećaj ošamućenosti nakon brzog ustajanja
English: Do not store above 30ºC.
Croatian: Ne čuvati na temperaturi iznad 30ºC.
English: Total exposure in the clinical development plan exceeded 1,500 patient-years.
Croatian: Ukupna izloženost u kliničkom razvojnom planu je prešla 1500 bolesnik-godina.
English: Do not take this medicine if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor advises you to do so.
Croatian: Nemojte uzimati ovaj lijek ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, osim ako Vam liječnik savjetuje da to učinite.
English: Gender is not expected to have any impact on dosing.
Croatian: Ne očekuje se da spol ima ikakvog utjecaja na doziranje.
English: After first opening: 18 weeks.
Croatian: Nakon prvog otvaranja: 18 tjedana.
English: The safety and efficacy of Constella in children aged 0 to18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Constelle u djece u dobi od 0 do 18 godina starosti nisu još ustanovljene.
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Croatian: Pogledajte upute kontracepcijskih pilula koje uzimate.
English: What you need to know before you take Constella 3.
Croatian: Što morate znati prije nego počnete uzimati Constellu
English: Because these other diseases may have the same symptoms as IBS, it is important that you report any change or irregularity in symptoms to your doctor promptly.
Croatian: Budući da ostale bolesti mogu imati iste simptome kao i IBS, važno je da što prije prijavite svom liječniku bilo koje promjene u simptomima.
English: Main secondary efficacy parameters
Croatian: Glavni sekundarni parametri djelotvornosti
English: Contact your doctor or pharmacist if you have taken too much of this medicine.
Croatian: Obratite se svom liječniku ili ljekarniku ako ste uzeli previše ovog lijeka.
English: Component of a multipack, can't be sold separately.
Croatian: Dio višestrukog pakiranja, ne može se prodavati zasebno.
English: A risk to the newborns/infants cannot be excluded.
Croatian: Rizik za novorođenčad/dojenčad se ne može isključiti.
English: 6.2 Incompatibilities
Croatian: 6.2 Inkompatibilinosti
English: The main symptoms of IBS with constipation include:
Croatian: Glavni simptomi IBS-a sa zatvorom uključuju:
English: As GC-C receptor is known to be overexpressed at early ages, children younger than 2 years may be particularly sensitive to linaclotide effects.
Croatian: Budući da je poznato da je receptor gvanilat ciklaza C izrazito eksprimiran u ranoj dobi, djeca mlađa od 2 godine mogu biti izrazito osjetljiva na učinke linaklotida.
English: The capsule should be taken at least 30 minutes before a meal.
Croatian: Kapsula se treba uzeti najmanje 30 minuta prije obroka.
English: Linaclotide (N =805)
Croatian: Linaklotid (N = 805)
English: IBS Degree of reli ef responder
Croatian: 1 IBS Degree of Relief Responder
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljene doze, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
English: The active metabolite was not detected in any of the 162 patients at any time point.
Croatian: Aktivni metabolit nije, niti u jednom trenutku, detektiran niti u jednom od 162 bolesnika.
English: Date of first authorisation: 26 November 2012 Date of latest renewal: 28 August 2017
Croatian: Datum posljednje obnove odobrenja: 28. Kolovoz 2017
English: Do not use this medicine if you notice any signs of damage to the bottle or any change in the appearance of the capsules.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo koju vrstu oštećenja na boci ili promjenu u izgledu kapsula.
English: It is expected that linaclotide is negligibly or not systemically distributed.
Croatian: Očekuje se da se linaklotid uopće ili zanemarivo sistemski distribuira.
English: The efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Croatian: Djelotvornost oralnih kontraceptiva može biti smanjena, te se preporučuje primjena dodatnih metoda kontracepcije kako bi se izbjeglo moguće zatajenje oralne kontracepcije (vidjeti informaciju o propisivanju oralne kontracepcije).
English: If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
Croatian: Ako imate vrlo teški proljev, kontracepcijske pilule možda neće djelovati ispravno te se preporučuje uporaba dodatne kontracepcijske metode.
English: • stomach flu (viral gastroenteritis)
Croatian: • želučana gripa (virusni gastroenteritis)
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Croatian: OBLIK I SADRŽAJ Tvrda kapsula.
English: Abdominal pain/discomfort responder
Croatian: Fig 2. Abdominal Pain/Discomfort Responder
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Constella therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Constella uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Pharmacotherapeutic group: Drugs for constipation, other drugs for constipation, ATC Code: A06AX04
Croatian: Farmakoterapijska skupina: lijekovi za konstipaciju, drugi lijekovi za konstipaciju, ATK oznaka: A06AX04
English: Side effects with frequency not known (frequency cannot be estimated from the available data):
Croatian: Nuspojave s nepoznatom učestalošću (učestalost se ne može utvrditi iz dostupnih podataka):
English: • lack of control over passing stools (faecal incontinence)
Croatian: • nedostatak kontrole pražnjenja stolice (fekalna inkontinencija)
English: Fertility Animal studies indicate that there is no effect on male or female fertility.
Croatian: Plodnost Ispitivanja na životinjama nisu pokazala utjecaj na muški ili ženski fertilitet.
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy of Constella in this age group has not been established.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina jer sigurnost i djelotvornost Constelle nije ustanovljena u tim dobnim skupinama.
English: As a precautionary measure, it is preferable to avoid the use of Constella during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu Constelle tijekom trudnoće.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala izravne ili neizravne štetne učinke u vezi reproduktivne toksičnosti (vidjeti dio 5.3).
English: This medicinal product should not be used in children and adolescents (see sections 4.4 and 5.1).
Croatian: Lijek se ne smije primjenjivati u djece i adolescenata (vidjeti dio 4.4 i 5.1).
English: Approximately half of the diarrhoea episodes started within the first week of treatment.
Croatian: Približno polovica svih slučajeva proljeva se pojavila u prvom tjednu liječenja.
English: What Constella is and what it is used for 2.
Croatian: Što je Constella i za što se koristi 2.
English: In the second clinical study (study 2), 800 patients were treated for 12 weeks, and then re-randomised for an additional 4 weeks treatment period.
Croatian: U drugom kliničkom ispitivanju (ispitivanje 2), 800 bolesnika je liječeno tijekom 12 tjedana, a nakon toga su ponovno randomizirani za dodatna 4 tjedna liječenja.
English: - Medicines that need careful and exact dosing, such as levothyroxine (a hormone to treat reduced function of the thyroid gland).
Croatian: - Lijekovi kojima je potrebno pažljivo i precizno doziranje, kao što su levotiroksin (hormon koji služi za liječenje smanjene funkcije tiroidne žlijezde).
English: Once the bottle is opened, the capsules should be used within 18-weeks.
Croatian: Nakon otvaranja boce, kapsule treba upotrijebiti u roku od 18 tjedana.
English: There is limited amount of data from the use of linaclotide in pregnant women.
Croatian: Ograničena je količina podataka o primjeni linaklotida u trudnica.
English: If you are breast-feeding, do not take Constella unless your doctor advises to do so.
Croatian: Ako dojite, nemojte uzimati Constellu osim ako Vam liječnik savjetuje da to učinite.
English: Treatment with linaclotide also resulted in significant improvements in validated and disease-specific Quality of Life measure (IBS-QoL; p<0.0001), and EuroQoL (p = 0.001).
Croatian: Liječenje linaklotidom je također rezultiralo značajnim poboljšanjima u validiranim i za bolest specifčnim mjerama kvalitete života (IBS-QoL; p< 0,0001) i EuroQoL (p= 0,001).
English: In both studies, these improvements were seen by week 1 and sustained over the entire treatment periods (Figures 1 and 2).
Croatian: U oba ispitivanja, poboljšanja su uočena u 1. tjednu te su se održala za vrijeme cjelokupnog razdoblja liječenja (Slika 1 i 2).
English: The most likely effect of taking too much Constella is diarrhoea.
Croatian: Najvjerojatniji učinak prekomjernog uzimanja Constelle je proljev.
English: Hypersensitivity to linaclotide or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na linaklotid ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In cases of severe or prolonged diarrhoea, absorption of other oral medicinal products may be affected.
Croatian: U slučajevima teškog ili produljenog proljeva, moguć je utjecaj na apsorpciju ostalih oralnih lijekova.
English: Your doctor has given this medicine to you after excluding other diseases, especially of your bowels and concluding that you suffer from IBS with constipation.
Croatian: Liječnik Vam je dao ovaj lijek nakon što je isključio ostale bolesti, pogotovo crijevne bolesti te nakon što je zaključio da bolujete od IBS-a sa zatvorom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: Some medicines may not work as effectively if you have severe or prolonged diarrhoea, such as: - Oral contraceptives.
Croatian: Drugi lijekovi i Constella Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove: Neki lijekovi nisu djelotvorni ako imate teški ili produljeni proljev, kao što su: - Oralni kontraceptivi.
English: The majority of reported cases of diarrhoea were mild (43%) to moderate (47%); 2% of treated patients experienced severe diarrhoea.
Croatian: Većina prijavljenih slučajeva proljeva su bili blagi (43%) do umjereni (47%); 2% liječenih bolesnika imalo je teške oblike proljeva.
English: Linaclotide has been shown not to cause rebound effect when the treatment was stopped after 3 months continuous treatment.
Croatian: Pokazalo se da linaklotid ne uzrokuje povratni (rebound) učinak nakon prekida kontinuiranog liječenja u trajanju od 3 mjeseca.
English: If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.
Croatian: Ako bolesnici nisu osjetili poboljšanje simptoma nakon 4 tjedna liječenja, potrebno ih je ponovno pregledati i procijeniti koristi i rizike nastavka liječenja.
English: The following adverse reactions were reported in controlled clinical studies at the recommended dose of 290 micrograms per day with frequencies corresponding to: 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) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: U kontroliranim kliničkim ispitivanjima su prijavljene sljedeće nuspojave pri preporučenoj dozi od 290 mikrograma dnevno s učestalošću koja odgovara: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Additional caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with cardiovascular (CV) diseases, diabetes, hypertension), and electrolyte control should be considered.
Croatian: Dodatne mjere opreza su potrebne ako su bolesnici skloni poremećajima ravnoteže vode ili elektrolita (npr. bolesnici starije dobi, bolesnici s kardiovaskularnim bolestima, dijabetesom, hipertenzijom), te se mora razmotriti kontrola elektrolita.
English: It is not absorbed into the body, but attaches to receptor called guanylate cyclase C on the surface of your gut.
Croatian: Ne apsorbira se u tijelo, već se veže na receptor koji se zove gvanilat ciklaza C koji se nalazi na površini Vaših crijeva.
English: - Laxatives.
Croatian: - Laksativi.
English: Constella should not be used in children and adolescents as it has not been studied in this population.
Croatian: Constella se ne smije primijeniti u djece i adolescenata jer lijek nije ispitivan u tim populacijama.
English: An overdose may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product, mainly diarrhoea.
Croatian: Predoziranje može uzrokovati simptome koji su rezultat pojačanih poznatih farmakodinamičkih učinaka lijeka, uglavnom proljev.
English: Take special care if you are older than 65 years, as there is a higher risk you experience diarrhoea.
Croatian: Posebne mjere opreza su potrebne ako ste stariji od 65 godina jer u toj dobi postoji veći rizik od proljeva.
English: Make sure you drink plenty of fluids to replace the water and electrolytes like potassium lost from the diarrhoea.
Croatian: Pazite da pijete mnogo tekućine kako bi nadoknadili vodu i elektrolite, kao što je kalij, izgubljene za vrijeme proljeva.
English: Linaclotide has been given orally to 1,166 patients with IBS-C in controlled clinical studies.
Croatian: Linaklotid je primijenjen peroralno na 1166 bolesnika s IBS-C-om u kontroliranim kliničkim ispitivanjima.
English: Some medicines may increase the risk of diarrhoea when taken with Constella, such as: - Medicines to treat stomach ulcers or excessive production of stomach acid called Proton Pump Inhibitors.
Croatian: Neki lijekovi mogu povećati rizik od proljeva kad se uzimaju s Constellom, kao što su: - Lijekovi namijenjeni liječenju čireva želuca ili prekomjernog stvaranja želučane kiseline, koji se zovu inhibitori protonske pumpe.
English: The diarrhoea resolved within seven days in about one third of patients, however 80 patients (50%) experienced diarrhoea with a duration of more than 28 days (representing 9.9% of all patients treated with linaclotide).
Croatian: Proljev se povukao unutar sedam dana u oko jedne trećine bolesnika, međutim 80 bolesnika (50%) imalo je proljev u trajanju duljem od 28 dana (što predstavlja 9,9% svih bolesnika liječenih linaklotidom).
English: Elderly (>65 years), hypertensive and diabetic patients reported diarrhoea more frequently as compared to the overall IBS-C population included in the clinical trials.
Croatian: Stariji bolesnici (> 65 godina), bolesnici s hipertenzijom i dijabetesom su prijavili proljev češće nego ukupna populacija s dijagnozom IBS-C-a uključena u klinička ispitivanja.