FrancophonIA/ELRC3.0 huggingface dataset:
English: 5 How to store Thymanax Contents of the pack and other information
Croatian: Kako Thymanax izgleda i sadržaj pakiranja
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Thymanax Lijek čuvajte izvan pogleda i dohvata djece.
English: Marketing Authorisation Holder Servier (Ireland) Industries Ltd Gorey road, Arklow, Co. Wicklow Ireland
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Servier (Ireland) Industries Ltd Gorey Road, Arklow, Co.
English: NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg tablets agomelatine
Croatian: NAZIV LIJEKA Thymanax 25 mg tablete agomelatin
English: Thymanax contains lactose
Croatian: Thymanax sadrži laktozu
English: Therefore, clinical consequences of ECT performed concomitantly with agomelatine treatment, Thymanax are considered to be unlikely.
Croatian: Stoga, nije vjerojatna pojava kliničkih posljedica kod istovremenog EKT liječenja i liječenja agomelatinom.
English: Caution should be exercised when prescribing Thymanax with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.
Croatian: Kombinacija s inhibitorima CYP1A2 (vidjeti dijelove 4.3 i 4.5) Thymanax s umjerenim CYP1A2 inhibitorima (npr. propranolol, enoksacin) treba propisivati uz oprez, jer oni mogu dovesti do povećane izloženosti agomelatinu.
English: How to store Thymanax
Croatian: Moguće nuspojave Kako čuvati Thymanax
English: 1 NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg film-coated tablets
Croatian: NAZIV LIJEKA Thymanax 25 mg filmom obložene tablete
English: Thymanax contains sodium
Croatian: Thymanax sadrži natrij
English: Thymanax is for oral use.
Croatian: Thymanax se uzima kroz usta.
English: Week 4 Week 8 Week 4 Week 8
Croatian: 4. tjedan 8. tjedan 4. tjedan 8. tjedan
English: However, no dose adjustment is considered necessary in these populations.
Croatian: Međutim, smatra se da nije potrebna prilagodba doze u ovim populacijama.
English: A risk to the suckling child cannot be excluded.
Croatian: Rizik za dojeno dijete se ne može isključiti.
English: Do not use a double dose to make up for the forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Do not put in any more drops until it is time for your next regular dose.
Croatian: Nemojte više ukapavati kapi sve dok ne dođe vrijeme za Vašu sljedeću redovnu dozu.
English: Talk to your doctor if you are pregnant or think you may be pregnant.
Croatian: Obratite se svom liječniku ako ste trudni ili mislite da biste mogli biti trudni.
English: The majority of side effects occur generally in and around the eyes.
Croatian: Većina nuspojava općenito se javlja u i oko očiju.
English: This medicine should not be used in children and adolescents below 18 years of age, as there is not enough information about its use in this age group.
Croatian: Ovaj se lijek ne smije primjenjivati u djece i adolescenata mlađih od 18 godina, jer nema dovoljno podataka o njegovoj primjeni u toj dobnoj skupini.
English: • sensitivity to light;
Croatian: • osjetljivost na svjetlo;
English: The use of this medicine should be avoided during pregnancy.
Croatian: Primjenu ovog lijeka treba izbjegavati tijekom trudnoće.
English: 20122 Milano Italy
Croatian: 20122 Milano Italija
English: No dose adjustment is required in patients 65 years of age and older.
Croatian: Nije potrebno prilagođavati dozu u bolesnika u dobi od 65 godina i starijih.
English: • abnormal sensation and discomfort in the eye, including feeling that there is something in the eye;
Croatian: • neobičan i neugodan osjećaj u oku, uključujući osjećaj da je nešto u oku;
English: Pharmacotherapeutic Group: {not yet assigned}, ATC code: {not yet assigned}.
Croatian: Farmakoterapijska skupina: {nije još dodijeljena}, ATK oznaka: {nije još dodijeljena}.
English: Results after 4 and 8 weeks of treatment
Croatian: Rezultati nakon 4 i 8 tjedana liječenja
English: The safety and efficacy of this medicinal product in children and adolescents below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: What OXERVATE is and what it is used for
Croatian: Što je OXERVATE i za što se koristi
English: Via Campo di Pile 67100 L'Aquila Italy
Croatian: Via Campo di Pile 67100 L'Aquila Italija
English: Continue with your next dose as scheduled.
Croatian: Nastavite sa sljedećom dozom prema rasporedu.
English: Follow these instructions carefully and ask your doctor or pharmacist if there is anything you do not understand.
Croatian: Pažljivo slijedite ove upute i pitajte svog liječnika ili ljekarnika ako nešto ne razumijete.
English: Contact lenses could interfere with the correct use of this medicine.
Croatian: Kontaktne leće mogu ometati ispravnu primjenu ovog lijeka.
English: Patients should be instructed to wash their hands before use.
Croatian: Bolesnike je potrebno uputiti da operu ruke prije primjene lijeka.
English: Best corrected distance visual acuity
Croatian: Najbolja korigirana oštrina vida na daljinu
English: They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
Croatian: Navedene su prema klasifikaciji organskih sustava i klasificirane na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • With your head still tilted back, blink a few times so that the medicine covers the surface of your eye.
Croatian: • S glavom još uvijek zabačenom prema natrag, trepnite nekoliko puta tako da lijek prekrije površinu oka.
English: Discard any remaining solution at the end of each day.
Croatian: Svu preostalu otopinu baciti na kraju svakog dana.
English: Take an individual vial of this medicine from the fridge in the morning (always at the same time each morning), and prepare it in the following way:
Croatian: Ujutro izvadite pojedinačnu bočicu ovog lijeka iz hladnjaka (svakog jutra uvijek u isto vrijeme) i pripremite je na sljedeći način:
English: Air bubbles may cause blockage and prevent the pipette from filling properly (especially at first withdrawal).
Croatian: Mjehurići zraka mogu blokirati kapaljku i spriječiti da se pravilno napuni (naročito kod prvog navlačenja).
English: Talk to your doctor before using this medicine: - if you have an infection in your eye, as the infection should be treated first.
Croatian: Obratite se svom liječniku prije nego primijenite ovaj lijek: - ako imate infekciju oka, jer je najprije potrebno liječiti infekciju.
English: Pull down the lower eyelid.
Croatian: Povucite donji kapak prema dolje.
English: The patient should be advised to contact the doctor in case of concern or a more severe eye reaction.
Croatian: Bolesniku je potrebno savjetovati da se u slučaju zabrinutosti ili jače očne reakcije obrati liječniku.
English: It should be noted that the frozen medicinal product received from the pharmacy could need up to 30 minutes for thawing.
Croatian: Potrebno je naglasiti da zamrznutom lijeku preuzetom u ljekarni može biti potrebno do 30 minuta da se otopi.
English: Other medicines and OXERVATE
Croatian: Drugi lijekovi i OXERVATE
English: Eye infections
Croatian: Očne infekcije
English: Repeat the above process (from picture 4 onwards) every 2 hours 6 times a day.
Croatian: Gornji postupak (od slike 4 nadalje) ponovite svaka 2 sata 6 puta na dan.
English: After cleaning, wait for approximately 1 minute to allow the valve to dry.
Croatian: Nakon čišćenja pričekajte otprilike 1 minutu da se ventil osuši.
English: If you use drops in both eyes, repeat the above instructions for your other eye using a new pipette (in this case, you will need to use 2 vials per day).
Croatian: Ako kapi primjenjujete u oba oka, ponovite gornje upute za drugo oko koristeći pri tom novu kapaljku (u tom slučaju trebat će Vam 2 bočice na dan).
English: For instructions on preparation and handling of the medicinal product before administration, see section 6.6.
Croatian: Za upute o pripremi i rukovanju lijekom prije primjene vidjeti dio 6.6.
English: In case of concomitant use with contact lenses, see section 4.4.
Croatian: U slučaju da se istodobno koriste kontaktne leće vidjeti dio 4.4.
English: The administration instructions above (steps 5 to 15) should be repeated every 2 hours (six times per day) using a new disinfectant wipe and a new pipette each time.
Croatian: Gore navedene upute za primjenu (koraci 5 do 15) moraju se ponoviti svaka 2 sata (šest puta u danu) koristeći se svaki put novim tupferom s dezinficijensom i novom kapaljkom.
English: From a microbiological point of view, the method of opening (i.e. by connecting the vial adapter to the vial) precludes the risk of microbial contamination.
Croatian: S mikrobiološke točke gledišta, način otvaranja (tj. stavljanje nastavka bočice na bočicu) podrazumijeva postojanje rizika od kontaminacije mikroorganizmima.
English: If this happens, wait until your vision clears before you drive or use machines.
Croatian: Ako se to dogodi, pričekajte da Vam se vid razbistri prije upravljanja vozilima ili rada sa strojevima.
English: • If you wear contact lenses, take them out before using the drops.
Croatian: • Ako nosite kontaktne leće, izvadite ih prije primjene kapi.
English: Pharmacist: Store in a freezer until dispensing.
Croatian: Ljekarnik: Čuvati u zamrzivaču do izdavanja.
English: Precautions to be taken before administering the medicinal product:
Croatian: Mjere opreza koje je potrebno poduzeti prije primjene lijeka:
English: • irritation in or around the eye;
Croatian: • nadraženost u ili oko oka;
English: Animal studies with cenegermin do not indicate direct or indirect harmful effects with respect to reproductive toxicity when administered subcutaneously (see section 5.3).
Croatian: Ispitivanja cenegermina na životinjama ne ukazuju na izravan ili neizravan štetan učinak u smislu reproduktivne toksičnosti kada se primjenjuje supkutano (vidjeti 5.3).
English: Eye drops containing these substances could slow down or interfere with the healing of your eye and should therefore be avoided during treatment with this medicine.
Croatian: Kapi za oko koje sadrže ove tvari mogu usporiti ili ometati cijeljenje oka i stoga ih je potrebno izbjegavati za vrijeme liječenja ovim lijekom.
English: Results after 8 weeks of treatment
Croatian: Rezultati nakon 8 tjedana liječenja
English: After cleaning, the valve should be allowed to dry for approximately one minute.
Croatian: Nakon čišćenja ostavite da se ventil osuši, otprilike jednu minutu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with the medicinal product in one or more subsets of the paediatric population in neurotrophic keratitis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka u jednoj ili više podskupina pedijatrijske populacije s neurotrofnim keratitisom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Since at the pharmacy this medicine is stored in a freezer, in case treatment is started right away after receiving the weekly carton, you will have to wait until the first vial is thawed (this could take up to 30 minutes).
Croatian: Budući da je u ljekarni ovaj lijek bio pohranjen u zamrzivaču, u slučaju da liječenje trebate započeti odmah po primitku kutije za tjednu terapiju, morate pričekati da se prva bočica lijeka otopi (to može potrajati do 30 minuta).
English: The opened vial must be used within 12 hours of first opening.
Croatian: Otvorenu bočicu mora se iskoristiti unutar 12 sati od prvog otvaranja.
English: The pipettes included in the delivery system are single-use only.
Croatian: Kapaljke uključene u sustav za primjenu su samo za jednokratnu uporabu.
English: The lesion or ulcer in your eye will worsen and could lead to infections or impaired vision.
Croatian: Oštećenje ili vrijed na Vašem oku može se pogoršati i može doći do infekcije ili oštećenja vida.
English: Cenegermin is a type of nerve growth factor (a human protein) which is naturally present on the eye surface.
Croatian: Cenegermin je vrsta faktora rasta živaca (ljudski protein) koji se prirodno nalazi na površini oka.
English: The treatment has minor influence on the ability to drive and use machines, as it may cause temporary blurred vision or other visual disturbances, which is expected to last a few minutes after instillation.
Croatian: Liječenje malo utječe na sposobnost upravljanja vozilima i rada sa strojevima, jer može uzrokovati privremeno zamućenje vida ili druge poremećaje vida, što može potrajati nekoliko minuta nakon ukapavanja.
English: What OXERVATE is and what it is used for What you need to know before you use OXERVATE How to use OXERVATE
Croatian: Što je OXERVATE i za što se koristi Što morate znati prije nego počnete primjenjivati OXERVATE
English: EU/1/17/1197/001
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1197/001
English: As soon as the patient is at home (and no later than 5 hours from when the patient receives the product at the pharmacy), the weekly carton should be placed into the refrigerator, at 2-8 °C.
Croatian: Čim stigne kući (i to ne kasnije od 5 sati nakon preuzimanja lijeka u ljekarni), kutiju za tjednu terapiju mora staviti u hladnjak na temperaturu 2 - 8 °C.
English: OXERVATE 56.5 % 69.6 % 58.0 % 74.0 % vehicle 37.5 % 29.2 % 19.6 % 43.1 % (p value) (0.191) (0.006) (0.001) (0.002)
Croatian: vehikulum 37,5 % 29,2 % 19,6 % 43,1 % (p vrijednost) (0,191) (0,006) (0,001) (0,002)
English: Corneal sensitivity inside lesion
Croatian: Senzibilitet rožnice unutar lezije
English: Specifically, more than 80 % of the 31 patients who were healed after initial OXERVATE 20 µg/ml treatment and for whom a response was available, remained completely healed at the end of the 12 months follow up period.
Croatian: Točnije, više od 80 % od 31 bolesnika koji su bili izliječeni nakon početnog liječenja lijekom OXERVATE 20 µg/ml i za koje su podaci bili dostupni, na kraju 12-mjesečnog razdoblja praćenja i dalje je bilo potpuno izliječeno.
English: At the ocular doses, cenegermin is not distributed throughout body tissues as there is no systemic absorption above the natural baseline levels.
Croatian: U dozama za oko cenegermin se ne distribuira u tjelesna tkiva jer nema sistemske apsorpcije iznad prirodnih početnih razina.
English: Treatment should be initiated and supervised by an ophthalmologist or a healthcare professional qualified in ophthalmology.
Croatian: Liječenje treba započeti i nadzirati oftalmolog ili zdravstveni radnik kvalificiran za područje oftalmologije.
English: • increase of tears (this could include symptoms such as discharge in the eye);
Croatian: • pojačano suzenje (to može uključivati simptome poput iscjetka iz oka);
English: If you wear contact lenses remove them before using this medicine and wait 15 minutes after using this medicine before reinserting them.
Croatian: Ako koristite kontaktne leće, skinite ih prije primjene ovog lijeka i pričekajte 15 minuta nakon njegove primjene prije nego ih ponovno stavite.
English: L-Methionine
Croatian: L-metionin
English: Systemic exposure to cenegermin is negligible or does not occur.
Croatian: Sistemska izloženost cenegerminu je zanemariva ili je nema.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this 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, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Use of corticosteroids or eye drops containing preservatives
Croatian: Primjena kortikosteroida ili kapi za oko koje sadrže konzervanse
English: • redness of the conjunctiva (mucous membrane that covers the front of the eye and lines the inside of the eyelids);
Croatian: • crvenilo spojnice (sluznice koja pokriva prednji dio oka i prekriva unutrašnjost kapaka);
English: If you use more than you should, flush the affected eye with lukewarm water.
Croatian: Ako primijenite više nego što ste trebali, isperite to oko mlakom vodom.
English: Eye reactions
Croatian: Očne reakcije
English: - if you are allergic to cenegermin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati OXERVATE: - ako ste alergični na cenegermin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: There are no data on the effects of cenegermin on human fertility.
Croatian: Nema podataka o učincima cenegermina na plodnost ljudi.
English: Make sure you do not touch your eye with the tip of the pipette.
Croatian: Pazite da vrhom kapaljke ne dotaknete oko.
English: If you use more OXERVATE than you should
Croatian: Ako primijenite više lijeka OXERVATE nego što ste trebali
English: Cenegermin may theoretically affect ocular cancer, as it is a growth factor.
Croatian: Teoretski, cenegermin može imati utjecaj na rak oka, budući da je faktor rasta.
English: Remove the weekly carton of OXERVATE from the insulated container and store it in a fridge as soon as you can (and in any case no later than 5 hours from when you receive the medicine from your pharmacist).
Croatian: Izvadite kutiju lijeka OXERVATE za tjednu terapiju iz izoliranog spremnika i spremite je u hladnjak što je prije moguće (i nikako ne kasnije od 5 sati nakon što ste lijek preuzeli od ljekarnika.
English: Pharmacokinetic profiling of patients included in studies found no accumulation effect of cenegermin.
Croatian: Na temelju farmakokinetičkih profila bolesnika uključenih u ispitivanja nije utvrđen učinak akumulacije cenegermina.
English: You can give the missed dose 2 hours after your last scheduled dose of the day, provided this is still within 12 hours from first opening the daily vial.
Croatian: Možete primijeniti propuštenu dozu 2 sata nakon posljednje doze prema rasporedu za taj dan ako je to još uvijek unutar 12 sati od prvog otvaranja bočice za taj dan.
English: You should continue your treatment for 8 weeks.
Croatian: Liječenje morate nastaviti tijekom 8 tjedana.
English: To withdraw and administer each dose of this medicine, follow the steps below:
Croatian: Za navlačenje i primjenu svake doze ovog lijeka, moraju se slijediti dolje opisani koraci:
English: Using more OXERVATE than is recommended is not likely to be harmful.
Croatian: Nije vjerojatno da bi primjena više lijeka OXERVATE nego je preporučeno mogla biti štetna.
English: Patients should be instructed to remove contact lenses before applying OXERVATE and to wait 15 minutes after instillation of the dose before reinsertion, because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin onto the area of the corneal lesion.
Croatian: Bolesnike je potrebno uputiti da skinu kontaktne leće prije primjene lijeka OXERVATE i pričekaju 15 minuta nakon ukapavanja doze prije nego ponovno stave leće, jer one (bilo terapijske ili korektivne) teoretski mogu ograničiti distribuciju cenegermina po području kornealne lezije.
English: If you forget to use OXERVATE
Croatian: Ako ste zaboravili primijeniti OXERVATE
English: • If a drop misses your eye, try again, using a new pipette and wipe.
Croatian: • Ako kap promaši oko, pokušajte ponovno koristeći se novom kapaljkom i novim tupferom.
English: Patients considered completely healed at the end of 8 weeks of treatment with OXERVATE did not tend to have recurrences within the 12 months follow-up period of study NGF0212.
Croatian: U bolesnika koji su smatrani potpuno izliječenima na kraju 8 tjedana liječenja lijekom OXERVATE nije bilo tendencije pojave recidiva unutar 12 mjeseci razdoblja praćenja u ispitivanju NGF0212.
English: In both studies patients received OXERVATE or vehicle 6 times daily in the affected eye(s) for 8 weeks, and underwent a follow-up period.
Croatian: U oba ispitivanja bolesnici su primali OXERVATE ili vehikulum 6 puta na dan u zahvaćeno oko (oči) kroz 8 tjedana i potom su uključeni u razdoblje praćenja.
English: Patient: Store in a refrigerator for a maximum of 7 days.
Croatian: Bolesnik: Čuvati u hladnjaku najdulje 7 dana.
English: Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
Croatian: Liječenje umjerenog (perzistentno oštećenje epitela) ili teškog (kornealni ulkus) neurotrofnog keratitisa u odraslih.
English: • Check the pipette to ensure it contains the eye drops, solution.
Croatian: • Provjerite kapaljku i uvjerite se da sadrži otopinu, kapi za oko.
English: This is a disease affecting the cornea (the transparent layer in the front part of the eye) which causes defects on the outer surface of the cornea that do not heal naturally or corneal ulcers.
Croatian: To je bolest koja zahvaća rožnicu (prozirni sloj prednjeg dijela oka) i uzrokuje oštećenja vanjske površine rožnice koja prirodno ne zarastaju ili ulkuse rožnice.
English: The multi-dose vial containing the product should be prepared according to the following instructions:
Croatian: Višedozna bočica s lijekom mora se pripremiti prema sljedećim uputama:
English: Only use this medicine in your affected eye(s).
Croatian: Ovaj lijek primjenjujte samo u bolešću zahvaćeno oko (oči).
English: It is recommended that these patients continue to be monitored for cancer progression during and after treatment with this medicinal product.
Croatian: U ovih se bolesnika preporučuje nastavak praćenja kako bi se uočilo postojanje progresije raka tijekom i nakon liječenja ovim lijekom.
English: Use a new disinfectant wipe and a new pipette each time.
Croatian: Svaki put upotrijebite novi tupfer s dezinficijensom i novu kapaljku.
English: • After each use throughout the day, place the vial back in the fridge (or keep it below 25 °C) for the rest of the day, with the vial adapter still connected.
Croatian: • Nakon svake primjene tijekom dana stavite bočicu natrag u hladnjak (ili je držite na temperaturi do 25 °C) tijekom ostatka dana, s još uvijek pričvršćenim nastavkom za bočicu.
English: Each pipette should be discarded immediately after using, even if there is still some liquid left in it.
Croatian: Svaka kapaljka mora se baciti neposredno nakon uporabe, čak i ako je u njoj ostalo još tekućine.
English: There are no data from the use of cenegermin in pregnant women.
Croatian: Nema podataka o primjeni cenegermina u trudnica.
English: pH 7.0-7.4 and osmolarity 280-320 mOsm/kg.
Croatian: Bistra, bezbojna otopina s pH vrijednošću 7,0-7,4 i osmolarnošću 280-320 mOsm/kg.
English: Do not use this medicine after the expiry date which is stated on the outer carton and vial label after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskoj kutiji i naljepnici bočice iza oznake "EXP".
English: Avoid touching the surface of the adapter.
Croatian: Izbjegavajte doticaj s površinom nastavka.
English: The most commonly reported adverse reactions in patients suffering from neurotrophic keratitis and treated with OXERVATE during clinical studies include eye pain (11.1 %), eye inflammation (8.3 %), which may include anterior chamber inflammation and hyphaema; lacrimation increased (5.6 %), with symptoms such as eye discharge; eyelid pain (5.6 %) and foreign body sensation in the eye (5.6 %).
Croatian: Najčešće prijavljivane nuspojave u bolesnika s neurotrofnim keratitisom liječenih lijekom OXERVATE tijekom kliničkih ispitivanja uključuju bol u oku (11,1 %), upalu oka (8,3 %) koja može uključivati upalu prednje sobice i hifemu, pojačano suzenje (5,6 %) sa simptomima poput iscjetka iz oka, bol kapka (5,6 % i osjećaj stranog tijela u oku (5,6 %).