FrancophonIA/ELRC3.0 huggingface dataset:
English: PegIntron 100 micrograms powder and solvent for solution for injection in pre-filled pen peginterferon alfa-2b
Croatian: PegIntron 100 mikrograma prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici peginterferon alfa-2b
English: NA
Croatian: IU
English: Package inserts of thioridazine should be referred to when co-administering with the product (PegIntron)
Croatian: Potrebno je pročitati uputu o lijeku za tioridazin kada se primjenjuje istodobno s ovim lijekom (PegIntron).
English: st dose reduction of PegIntron is to 1 µg/kg/week.
Croatian: Napomena 2: u odraslih bolesnika prvo smanjenje doze lijeka PegIntron je na 1 μg/kg na tjedan.
English: Both active substances have been available in the European Union (EU) as separate preparations for a number of years.
Croatian: Obje djelatne tvari dostupne su u Europskoj Uniji (EU) kao zasebni pripravci već niz godina.
English: Although the effect of Omidria on pain was modest, it was considered clinically important.
Croatian: Iako je djelovanje lijeka Omidria na bol skromno, smatra se klinički važnim.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Omidria on 28 July 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Omidria na snazi u Europskoj uniji od 28. srpnja 2015.
English: Other information about Omidria
Croatian: Ostale informacije o lijeku Omidria
English: This makes lens replacement surgery easier.
Croatian: To olakšava kiruršku zamjenu leće.
English: With regard to the safety of Omidria, the medicine was generally well tolerated.
Croatian: S obzirom na sigurnost lijeka Omidria, lijek se općenito dobro podnosi.
English: What is Omidria and what is it used for?
Croatian: Što je Omidria i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Omidria.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Omidria.
English: The lens is the part of the eye that focuses light passing through the pupil and allows clear vision.
Croatian: Leća je dio oka koji fokusira svjetlo koje prolazi kroz zjenicu i omogućuje bistar vid.
English: What measures are being taken to ensure the safe and effective use of Omidria?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Omidria?
English: It is not intended to provide practical advice on how to use Omidria.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Omidria.
English: In addition, 7% (29 out of 403) of patients receiving Omidria experienced moderate-to-severe pain compared with 14% (57 out of 403) of patients given placebo, and 25% (104 out of 403) were painfree in the early period following surgery, compared with 17% (69 out of 403) of patients receiving placebo.
Croatian: Nadalje, 7 % (29 od 403) bolesnika koji su primali lijek Omidria iskusilo je umjerenu do ozbiljnu bol u usporedbi s 14 % (57 od 403) bolesnika koji su primali placebo, te 25 % (104 od 403) nije osjetilo nikakvu bol u ranom razdoblju nakon kirurškog zahvata, u usporedbi sa 17 % (69 od 403) bolesnika koji su primili placebo.
English: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID).
Croatian: Ketorolac je nesteroidan protuupalni lijek (NSAID).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Omidria are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Omidria nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Phenylephrine is a ‘selective alpha-1 adrenergic receptor agonist', which attaches to and activates alpha-1 adrenergic receptors that are found on smooth muscle cells, causing these muscles to contract.
Croatian: Fenilefrin je "selektivan agonist alfa-1 adrenergičkog receptora" koji se vezuje na i aktivira alfa-1 adrenergičke receptore koji se nalaze na glatkim mišićnim stanicama, uzrokujući kontrakcije mišića.
English: Why is Omidria approved?
Croatian: Zašto je Omidria odobren?
English: This is a type of surgery in which a new lens is implanted into the eye.
Croatian: Ovo je tip kirurškog zahvata tijekom kojeg se nova leća ugrađuje u oko.
English: A risk management plan has been developed to ensure that Omidria is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Omidria.
English: In both studies, the main measures of effectiveness were the change in diameter of the pupil by the end of the surgery, and how much eye pain patients felt soon after surgery, as indicated by the patient using a standard pain scale from 1 to 100.
Croatian: U oba ispitivanja glavne mjere djelotvornosti bile su promjene u promjeru zjenice po završetku kirurškog zahvata, te koliku je bol bolesnik osjetio u oku odmah nakon kirurškog zahvata, kako je naveo bolesnik koji je koristio standardnu skalu boli od 1 do 100.
English: Omidria must not be used in patients who have narrow-angle glaucoma, a serious condition of the eye in which the pressure inside the eye rises rapidly because fluid cannot drain out.
Croatian: Omidria se ne smije koristiti u bolesnika koji imaju glaukom uskog kuta, ozbiljno stanje oka pri kojem se pritisak unutar oka brzo povećava zato što tekućina ne može izaći.
English: What are the risks associated with Omidria?
Croatian: Koji su rizici povezani s lijekom Omidria?
English: When applied to the eye, ketorolac reduces the production of prostaglandins in the eye and thereby reduces the pain and inflammation caused by eye surgery.
Croatian: Kada se primjenjuje na oko, ketorolac smanjuje proizvodnju prostaglandina u oku i stoga smanjuje bol i upalu koju uzrokuje kirurški zahvat na oku.
English: The ophthalmologist may also prescribe eye drops commonly used before and after the surgery to help prevent eye infections and pain.
Croatian: Oftamolog može također propisati kapi za oči koje se najčešće koriste prije i nakon kirurškog zahvata kako bi pomogao u sprječavanju infekcija i boli.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Omidria, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Omidria nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Omidria has been investigated in two main studies involving a total of 821 patients undergoing lens replacement surgery, in which it was compared with placebo (a dummy treatment).
Croatian: Omidria je ispitana u dva glavna ispitivanja koja su obuhvatila ukupno 821 bolesnika koji su se podvrgavali kirurškoj zamijeni leća, a u kojima je ovaj lijek uspoređen s placebom (lažnim liječenjem).
English: The most common side effects with Omidria (which may affect up to 1 in 10 people) are eye pain, anterior chamber inflammation (inflammation of the fluid-filled space inside the eye between the iris and the cornea), conjunctival hyperaemia (redness of the membrane that lies over the white part of the eye), photophobia (increased sensitivity of the eyes to light), corneal oedema (swelling of the transparent layer in front of the eye that covers the pupil and iris) and inflammation.
Croatian: Najčešće nuspojave lijeka Omidria (mogu se javiti u do 1 na 10 bolesnika) su bol u oku, upala prednje komore (upala prostora ispunjenog tekućinom unutar oka između šarenice i rožnice), konjuktivilna hiperemija (crvenilo membrane koja se nalazi preko bijelog dijela oka), fotofobija (povećana osjetljivost oka na svjetlo), edem rožnice (oticanje prozirnog dijela u prednjem dijelu oka koje pokriva zjenicu i šarenicu) i upala.
English: The recommended dose is 4 ml of Omidria diluted in 500 ml of irrigation solution, to be used during the surgery to replace the lens.
Croatian: Preporučena doza iznosi 4 ml lijeka Omidria razrijeđen u 500 ml otopine za ispiranje koja se koristi tijekom kirurškog zahvata za zamjenu leća.
English: It can only be obtained with a prescription and must be given by a qualified ophthalmological surgeon (eye surgery specialist) experienced in lens replacement.
Croatian: Izdaje se samo na liječnički recept i smije se primjenjivati samo od strane oftalmološkog kirurga (specijalista za očnu kirurgiju) iskusnog u zamijeni leće.
English: Omidria phenylephrine / ketorolac
Croatian: Omidria fenilefrin / ketorolak
English: With respect to pain, patients treated with Omidria reported an average pain score of around 4, compared with around 9 for those given placebo.
Croatian: Kad je u pitanju doživljaj boli, bolesnici koji su liječeni lijekom Omidria prijavili su prosječan rezultat boli od otprilike 4, u usporedbi s otprilike 9 za osobe koje su primale placebo.
English: The incidence of side effects with Omidria was similar to that reported in patients receiving placebo.
Croatian: Incidencija nuspojava s lijekom Omidria slična je onoj prijavljenoj u bolesnika koji su primili placebo.
English: Both studies showed that the pupil remained dilated during surgery in patients given Omidria (+0.1 mm), while it contracted in those given placebo (-0.5 mm).
Croatian: Oba su ispitivanja pokazala da je rožnica ostala raširena tijekom kirurškog zahvata u bolesnika koji je primio lijek Omidria (+0,1 mm), dok se zjenica kontrahirala u osoba koje su primile placebo (-0,5 mm).
English: It works by blocking certain enzymes called cyclo-oxygenases, which produce prostaglandins, substances that are involved in pain and inflammation processes.
Croatian: Djeluje inhibirajući enzim naziva ciklooksigenaza, koji proizvodi prostaglandine, tvari uključene u bolne i upalne procese.
English: Omidria is a medicine used in adults during lens replacement surgery in the eye to keep the pupil dilated (widened) and prevent its contraction, and to reduce eye pain after surgery.
Croatian: Omidria je lijek koji se primjenjuje u odraslih osoba tijekom kirurške zamijene leće oka kako bi se zjenica zadržala dilatiranom (raširenom) te se spriječile kontrakcije zjenice i smanjila bol u oku nakon kirurškog zahvata.
English: These side effects are typical following lens replacement surgery, and most were mild to moderate in severity and resolved spontaneously.
Croatian: Ove nuspojave su tipične nakon kirurške zamijene leće, a većina je blaga do umjerena po stupnju ozbiljnosti te se spontano uklanja.
English: Fewer than 1 in 10 of the patients given Omidria had a pupil diameter below 6 mm (which makes surgery more difficult), whereas about 4 patients in 10 experienced this after being given placebo.
Croatian: Manje od 1 na 10 bolesnika koji su primili lijek Omidria imalo je promjer zjenice manji od 6 mm (što otežava kirurški zahvat), dok je otprilike 4 bolesnika na 10 iskusilo isto nakon što su primili placebo.
English: Omidria is available as a concentrate that is made up into an irrigation solution (a solution used to rinse the inside of the eye during surgery).
Croatian: Omidria je dostupna kao koncentrat za pripremu otopine za ispiranje (otopine koja se koristi za ispiranje unutrašnjosti oka tijekom kirurškog zahvata).
English: For practical information about using Omidria, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Omidria pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The full EPAR and risk management plan summary for Omidria can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za Omidria kao i sažetak plana upravljanja rizikom za lijek Omidria nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Omidria pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Omidria has been shown to be effective at maintaining pupil dilation and preventing pupil contraction during lens replacement surgery, which should help to make such surgery easier and safer.
Croatian: Dokazano je da je lijek Omidria djelotvoran u održavanju zjenice raširenom te da sprječava kontrakciju zjenice tijekom kirurške zamjene leće, što pomaže pri olakšavanju takvog kirurškog zahvata i čini ga sigurnijim.
English: How does Omidria work?
Croatian: Kako djeluje Omidria?
English: When applied to the eye, phenylephrine makes the muscle of the iris contract (tighten) and allows the pupil to widen.
Croatian: Kada se primjenjuje na oko, fenilefrin uzrokuje kontrakciju mišića šarenice (stezanje) i omogućuje širenje zjenice.
English: What benefits of Omidria have been shown in studies?
Croatian: Koje su koristi lijeka Omidria utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Omidria, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Omidria potražite u uputi o lijeku.
English: How is Omidria used?
Croatian: Kako se Omidria koristi?
English: Omidria contains the active substances phenylephrine and ketorolac.
Croatian: Omidria sadrži djelatne tvari fenilefrin i ketorolak.
English: What AZILECT is and what it is used for
Croatian: Što je AZILECT i za što se koristi
English: AZILECT may be taken with or without food.
Croatian: AZILECT se može uzeti sa ili bez hrane.
English: Smoking could decrease the amount of AZILECT in the blood.
Croatian: Pušenje može smanjiti količinu AZILECT-a u krvi.
English: Do not stop taking AZILECT without first talking to your doctor.
Croatian: Nemojte prestati uzimati AZILECT prije razgovora sa svojim liječnikom.
English: If you take more AZILECT than you should
Croatian: Ako uzmete više AZILECT-a nego što ste trebali
English: You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the unborn child are not known.
Croatian: Trebali biste izbjegavati uzimanje AZILECT-a ako ste trudni, jer nije poznato kako AZILECT utječe na trudnoću i nerođeno dijete.
English: What AZILECT looks like and contents of the pack
Croatian: Kako AZILECT izgleda i sadržaj pakiranja
English: MAO Inhibitors
Croatian: MAO inhibitori
English: Contents of the pack and other information What AZILECT contains
Croatian: Sadržaj pakiranja i druge informacije Što AZILECT sadrži
English: Take the AZILECT carton/ blister or bottle with you to show the doctor or pharmacist.
Croatian: Ponesite sa sobom AZILECT kutiju/blister ili bočicu da pokažete svom liječniku ili ljekarniku.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove .
English: Parkinson's disease is associated with symptoms of hallucinations and confusion.
Croatian: Halucinacije Parkinsonova bolest se povezuje sa simptomima halucinacija i konfuzije.
English: AZILECT helps to increase and sustain levels of dopamine in the brain.
Croatian: AZILECT pomaže u povećavanju i održavanju razina dopamina u mozgu.
English: Other medicines and AZILECT
Croatian: Drugi lijekovi i AZILECT
English: This might be enhanced if you take other medicines to treat the symptoms of your Parkinson's disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking AZILECT.
Croatian: To se može pojačati ako uzimate druge lijekove za liječenje simptoma Parkinsonove bolesti ili ako uzimate lijekove koji Vas mogu omamiti ili pijete alkohol dok uzimate AZILECT.
English: Tablet 30 tablets
Croatian: Tableta 30 tableta
English: - If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na razagilin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)..
English: The safety and efficacy of AZILECT in children and adolescents have not been established.
Croatian: Sigurnost i djelotvornost lijeka AZILECT u djece i adolescenata nisu ustanovljene.
English: What you need to know before you take AZILECT Do not take AZILECT
Croatian: Što morate znati prije nego počnete uzimati AZILECT
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets
Croatian: 7 tableta 10 tableta 28 tableta 30 tableta 100 tableta 112 tableta
English: Non-clinical data reveal no special hazard for humans based on the standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala,
English: Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others.
Croatian: Obavijestite Vašeg liječnika ako Vi ili Vaša obitelj/skrbnik primijetite da razvijate neuobičajeno ponašanje u smislu da se ne možete oduprijeti nagonu, potrebi ili žudnji za obavljanjem određenih aktivnosti, škodljivih ili loših za Vas ili druge.
English: Elderly No change in dose is required for elderly patients (see section 5.2).
Croatian: Nije potrebna promjena doze kod starijih bolesnika (vidjeti dio 5.2).
English: The recommended dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily.
Croatian: Preporučena doza AZILECT-a je 1 tableta od 1 mg uzeta na usta jedanput dnevno.
English: 21 February 2005
Croatian: Datum prvog odobrenja: 21. veljače 2005.
English: There is no relevant use of AZILECT in the paediatric population in the indication Parkinson's disease.
Croatian: Nema relevantne primjene lijeka AZILECT u pedijatrijskoj populaciji za indikaciju Parkinsonove bolesti.
English: Aluminium/aluminium blister packs of 7, 10, 28, 30, 100 or 112 tablets.
Croatian: Blisteri Aluminij/aluminij blister pakiranja od 7, 10, 28, 30, 100 ili 112 tableta.
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Croatian: Metabolizam razagilina se odvija kroz dva glavna puta: N-dealkilacijom i/ili hidroksilacijom te nastaju: 1-aminoindan, 3-hidroksi-N-propargil-1 aminoindan i 3-hidroksi-1 aminoindan.
English: Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Croatian: Simptomi zabilježeni nakon predoziranja AZILECT-om uključivali su blago euforično raspoloženje (blagi oblik manije), krajnje visok krvni tlak i serotoninski sindrom (vidjeti dio 4).
English: Age has little influence on rasagiline pharmacokinetics in the elderly (> 65 years) (see section 4.2)
Croatian: Starije osobe Dob slabo utječe na farmakokinetiku razagilina u starijih osoba (> 65 godina) (vidjeti dio 4.2).
English: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.
Croatian: Tablete su dostupne u blister pakiranjima od 7, 10, 28, 30, 100 i 112 tableta ili u bočici koja sadrži 30 tableta.
English: The recommended dose of rasagiline is 1 mg (one tablet of AZILECT) once daily, to be taken with or without levodopa.
Croatian: Preporučena doza razagilina je 1 mg (jedna tableta lijeka AZILECT) jednom dnevno koja se uzima s levodopom ili bez nje.
English: If you stop taking AZILECT
Croatian: Ako prestanete uzimati AZILECT
English: If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately.
Croatian: Ako mislite da ste možda uzeli previše AZILECT tableta, odmah se obratite svom liječniku ili ljekarniku.
English: Very common (may affect more than 1 in 10 people) - Involuntary movements (dyskinesia) - Headache
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) - nevoljni pokreti (diskinezija) - glavobolja
English: Levodopa and other Parkinson's disease medicinal products
Croatian: Levodopa i drugi lijekovi za Parkinsonovu bolest
English: If you forget to take AZILECT
Croatian: Ako ste zaboravili uzeti AZILECT
English: Therefore, AZILECT is not recommended for use under the age of 18.
Croatian: Stoga se ne preporučuje primjena lijeka AZILECT u djece i adolescenata mlađih od 18 godina.
English: There is no relevant use of AZILECT in children and adolescents.
Croatian: Nema relevantne primjene lijeka AZILECT u djece i adolescenata.
English: AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson's disease).
Croatian: AZILECT može uzrokovati omamljenost i može učiniti da iznenada zaspite tijekom dnevnih aktivnosti, posebice ako uzimate dopaminergičke lijekove (primjenjuju se za liječenje Parkinsonove bolesti).
English: Cerebrovascular Serotonin
Croatian: Cerebrovaskula Serotoninski
English: If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping AZILECT treatment.
Croatian: Ako započinjete liječenje fluoksetinom ili fluvoksaminom, morate čekati najmanje 14 dana nakon prekida liječenja AZILECT-om.
English: The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Croatian: Istodobnu primjenu AZILECT-a s antidepresivima koji sadrže fluoksetin ili fluvoksamin potrebno je izbjegavati.
English: AZILECT 1 mg tablets
Croatian: AZILECT 1 mg tablete
English: Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included hypomania, hypertensive crisis and serotonin syndrome.
Croatian: Simptomi Simptomi prijavljeni nakon predoziranja razagilinom u dozama u rasponu od 3 mg do 100 mg uključivali su hipomaniju, hipertenzivnu krizu i serotoninski sindrom.
English: If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.
Croatian: Ako započinjete liječenje AZILECT-om, morate čekati najmanje 5 tjedana nakon prekida liječenja fluoksetinom.
English: AZILECT is indicated in adults for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Croatian: AZILECT je indiciran u odraslih za liječenje idiopatske Parkinsonove bolesti kao monoterapija (bez levodope) ili kao dodatna terapija (s levodopom) u bolesnika s fluktuacijama prilikom isteka doze.
English: How to take AZILECT
Croatian: Kako uzimati AZILECT
English: Package leaflet: Information for the user AZILECT 1 mg tablets rasagiline
Croatian: Uputa o lijeku: Informacije za korisnika AZILECT 1 mg tablete razagilin
English: Non-clinical data indicate that rasagiline inhibits prolactin secretion and thus, may inhibit lactation.
Croatian: Dojenje Neklinički podaci pokazuju da razagilin inhibira sekreciju prolaktina i prema tome, može inhibirati laktaciju.
English: Patients with Parkinson's disease are particularly vulnerable to the adverse reactions of hypotension due to existing gait issues.
Croatian: Parkinsonovom bolesti posebno su osjetljivi na nuspojave hipotenzije zbog postojećih problema s hodanjem.
English: AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Croatian: AZILECT sadrži djelatnu tvar razagilin te se primjenjuje za liječenje Parkinsonove bolesti u odraslih.