FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the Committee is of the opinion that the observed deviation is attributed to variability between subjects and to physiological conditions after intake of a high fat meal and this does not translate into differences in quality between Methylphenidate Hexal and the reference formulations.
Croatian: Međutim, Povjerenstvo smatra da se uočeno odstupanje pripisuje varijabilnosti između ispitanika i fiziološkim uvjetima nakon unosa obroka s mnogo masti i to ne odražava razlike u kvaliteti formulacija lijeka Methylphenidate Hexal i referentnog lijeka.
English: Overall summary of the scientific evaluation of Methylphenidate Hexal and associated names (see Annex I)
Croatian: Cjelokupni sažetak znanstvene procjene lijeka Methylphenidate Hexal i povezanih imena (vidjeti Dodatak I)
English: the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Methylphenidate Hexal and associated names (see Annex I).
Croatian: CHMP je preporučio izdavanje odobrenja za stavljanje u promet za koje sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ostaju u skladu sa završnim inačicama donesenim tijekom postupka koordinacijske skupine kako je navedeno u Dodatku III za lijek Methylphenidate Hexal i povezana imena (vidjeti Dodatak I).
English: The repeat-use MRP was closed on day 210, with Germany which did not agree with the conclusions of the RMS's assessment report and which raised a potential serious risk to public health (PSRPH).
Croatian: MRP za ponovljenu uporabu završen je 210. dana i većina dotičnih država članica složila se sa zaključcima izvješća o procjeni referentne države članice, osim Njemačke i Nizozemske koje su postavile pitanje potencijalnih ozbiljnih rizika za ljudsko zdravlje (PSRPH, eng. potential serious risk to public health).
English: The major concern raised by Germany could not be solved during the CMD(h) referral, and the issue was therefore referred to the CHMP.
Croatian: Glavno pitanje koje su postavile Njemačka i Nizozemska nije se moglo riješiti upućivanjem u CMD(h), stoga je predmet proslijeđen Povjerenstvu za lijekove za primjenu kod ljudi (CHMP, eng.
English: Methylphenidate Hexal's formulation is designed with an outer coating containing the immediaterelease part surrounding the prolonged-release core (osmotic controlled).
Croatian: Formulacija lijeka Methylphenidate Hexal dizajnirana je s vanjskim slojem koji sadrži dio za neposredno oslobađanje i okružuje jezgru za produljeno oslobađanje (osmotski kontrolirano).
English: The application for Methylphenidate Hexal is therefore based on bioequivalence studies between the applied and the reference product.
Croatian: Stoga se primjena lijeka Methylphenidate Hexal temelji na ispitivanjima bioekvivalencije primijenjenog i referentnog lijeka.
English: Waiver of studies under fed conditions for the 18 mg and 36 mg strengths The bioequivalence under fed conditions has only been studied in the 54 mg strength.
Croatian: Odustajanje od ispitivanja u uvjetima uz hranu za jačine od 18 mg i 36 mg Bioekvivalencija u uvjetima uz hranu ispitivala se samo za jačinu od 54 mg.
English: Methylphenidate Hexal which contains the active substance methylphenidate hydrochloride is an osmotic controlled prolonged release film coated tablet with a bi-layer core.
Croatian: Methylphenidate Hexal koji sadrži djelatnu tvar metilfenidat hidroklorid je filmom obložena tableta s osmotski kontroliranim produljenim oslobađanjem s jezgrom od dva sloja.
English: The repeat-use MRP marketing authorisation application presented for the medicinal product Methylphenidate Hexal 18mg, 36mg, 54mg tablets is a generic application in accordance with the Article 10.1 of the Directive 2001/83/EC.
Croatian: Zahtjev za davanje odobrenja za stavljanje gotovog lijeka u promet u postupku međusobnog priznavanja koji se može upotrijebiti više puta za lijek Methylphenidate Hexal u obliku tableta od 18 mg, 36 mg i 54 mg generički je zahtjev u skladu sa Člankom 10.1 Direktive 2001/83/EZ.
English: The results showed that bioequivalence was demonstrated for the studies under fasted conditions between Methylphenidate Hexal (18mg, 36mg, 54mg) and the reference product for the immediate and prolonged release phase.
Croatian: Rezultati su pokazali da je u ispitivanjima u uvjetima natašte dokazana bioekvivalencija lijeka Methylphenidate Hexal (18 mg, 36 mg, 54 mg) i referentnog lijeka za fazu neposrednog i produljenog oslobađanja.
English: • The Committed reviewed all the data submitted by the applicant in order to support the bioequivalence between Methylphenidate Hexal 18 mg, 36 mg, 54 mg prolonged release tablets and the reference product.
Croatian: • Povjerenstvo je pregledalo sve podatke koje je predao podnositelj zahtjeva kako bi potkrijepio bioekvivalenciju između tableta lijeka Methylphenidate Hexal s produljenim oslobađanjem od 18 mg, 36 mg, 54 mg i referentnog lijeka.
English: The fed study failed to fulfil the standard acceptance criteria for bioequivalence for the immediaterelease phase (AUC(0-2h) and Cmax(0-2h)).
Croatian: Ispitivanja uz hranjenje nisu zadovoljila standardne zahtjeve za prihvaćanje po pitanju bioekvivalencije u fazi neposrednog oslobađanja (PIK(0-2h) i Cmax(0-2h)).
English: Methylphenidate Hexal (18 mg, 36 mg and 54 mg) is indicated in the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged between 6 and 18 years old once daily in the morning and can be taken with or without food.
Croatian: Attention Deficit/Hyperactivity Disorder) kod djece u dobi od 6 do 18 godina jednom dnevno ujutro i može se uzimati uz obrok ili bez obroka.
English: This overview was last updated in 04-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran: 04-2018.
English: Further information on Panretin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Panretin možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure of effectiveness was the proportion of patients
Croatian: Glavna mjera djelotvornosti bio je
English: • other treatments (radiotherapy or chemotherapy) are not suitable, and
Croatian: • drugi oblici liječenja (radioterapija ili kemoterapija) nisu prikladni i
English: Panretin should be used for up to 12 weeks.
Croatian: Panretin treba primjenjivati u razdoblju do 12 tjedana.
English: Depending on each lesion's response to treatment, the number of applications can be increased to three or four times a day.
Croatian: Ovisno o reakciji svake pojedine lezije na liječenje, broj primjena može se povećati na tri ili četiri puta na dan.
English: • the skin is not broken and the lesions are not swollen,
Croatian: • koža nije oštećena i lezije nisu otečene,
English: It may be used after this period but only on lesions that are responding to treatment.
Croatian: Može se primjenjivati i nakon tog razdoblja, ali samo na lezije koje reagiraju na liječenje.
English: The marketing authorisation holder is Eisai Ltd.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet je Eisai Ltd.
English: Panretin is used when:
Croatian: Panretin se primjenjuje kada:
English: Around 35% and 37% of the patients using Panretin responded to treatment compared with 18% and 7% of the patients using placebo.
Croatian: Odgovor na liječenje zabilježen je u otprilike 35 % i 37 % bolesnika koji su koristili Panretin, u odnosu na 18 % i 7 % u bolesnika koji su koristili placebo.
English: It must not be used to treat lesions that are close to areas affected by other skin disorders.
Croatian: Ne smije se primjenjivati za liječenje lezija koje su blizu područja zahvaćenih drugim kožnim poremećajima.
English: Panretin must also not be used in women who are pregnant or who are planning a pregnancy, or who are breast-feeding.
Croatian: Lijek Panretin također se ne smije primjenjivati u žena koje su trudne ili planiraju trudnoću, ili u žena koje doje.
English: Other information about Panretin
Croatian: Ostale informacije o lijeku Panretin
English: Panretin is available as a gel to be applied to the skin lesions twice a day, using enough gel to cover each lesion with a generous coating and then leaving it to dry for three to five minutes before covering with clothing.
Croatian: Panretin je dostupan u obliku gela koji se nanosi na lezije na koži dva puta na dan u količini koja je dovoljna za pokrivanje svake lezije izdašnim slojem gela te se potom ostavlja tri do pet minuta da se osuši prije nego što ga se pokrije tkaninom.
English: What is Panretin and what is it used for?
Croatian: Što je Panretin i za što se koristi?
English: • treatment for visceral (internal) Kaposi's sarcoma is not needed.
Croatian: • liječenje visceralnog Kaposijevog sarkoma (u unutrašnjosti tijela) nije potrebno.
English: who responded to treatment.
Croatian: udio bolesnika koji je odgovorio na liječenje.
English: A patient was considered to have responded to treatment if their lesions reduced in area or flattened by a certain amount depending on the type of lesions.
Croatian: Smatra se da je bolesnik odgovorio na liječenje ako je površina ili debljina njegovih lezija smanjena za određeni udio ovisno o vrsti lezije.
English: The European Medicines Agency decided that Panretin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Panretin nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: • the lesions have not responded to HIV treatment,
Croatian: • lezije nisu reagirale na liječenje HIV-a,
English: For more information about using Panretin, see the package leaflet or contact a doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Panretin pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Panretin 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 Panretin nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Side effects reported with Panretin are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Panretin pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Panretin and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Panretin i zašto je odobren u EU-u
English: Panretin received a marketing authorisation valid throughout the EU on 11 October 2000.
Croatian: Lijek Panretin dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 11. listopada 2000.
English: What are the risks associated with Panretin?
Croatian: Koji su rizici povezani s lijekom Panretin?
English: Why is Panretin authorised in the EU?
Croatian: Zašto je lijek Panretin odobren u EU-u?
English: Panretin must not be used in people who may be hypersensitive (allergic) to retinoids in general, alitretinoin, or any of the other ingredients.
Croatian: Lijek Panretin ne smije se primjenjivati u osoba koje mogu biti preosjetljive (alergične) na retinoide općenito ili bilo koji drugi sastojak lijeka.
English: Panretin was compared with placebo (a dummy treatment) in two 12-week studies involving a total of 402 patients with Kaposi's sarcoma.
Croatian: Panretin je uspoređen s placebom (prividno liječenje) u dvama ispitivanjima u trajanju od 12 tjedana koja su obuhvatila ukupno 402 bolesnika s Kaposijevim sarkomom.
English: As for all medicines, data on the use of Panretin are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Panretin kontinuirano se prate.
English: Healthy skin around the lesion should be avoided.
Croatian: Mora se izbjegavati nanošenje gela na zdravu kožu oko lezija.
English: What measures are being taken to ensure the safe use of Panretin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Panretin?
English: Panretin is a medicine used to treat the skin lesions seen in AIDS patients with Kaposi's sarcoma (a type of skin cancer).
Croatian: Panretin je lijek koji se primjenjuje za liječenje lezija na koži uočenih u bolesnika s AIDS-om koji imaju Kaposijev sarkom (vrsta raka kože).
English: Panretin was more effective than placebo at treating Kaposi's sarcoma.
Croatian: Lijek Panretin pokazao se djelotvornijim od placeba u liječenju Kaposijevog sarkoma.
English: Panretin can only be obtained with a prescription and treatment should be started and maintained by a doctor with experience in treating Kaposi's sarcoma.
Croatian: Panretin se izdaje samo na liječnički recept, a liječenje mora započeti i voditi liječnik s iskustvom u liječenju Kaposijevog sarkoma.
English: What benefits of Panretin have been shown in studies?
Croatian: Koje su koristi od lijeka Panretin dokazane u ispitivanjima?
English: How does Panretin work?
Croatian: Kako djeluje Panretin?
English: How is Panretin used?
Croatian: Kako se Panretin koristi?
English: The active substance in Panretin, alitretinoin, is an anticancer agent that belongs to the group ‘retinoids', substances that are derived from vitamin A. The exact way alitretinoin works in Kaposi's sarcoma is unknown.
Croatian: Djelatna tvar u lijeku Panretin, alitretinoin, sredstvo je za liječenje raka koje pripada skupini retinoida, tvari dobivenih iz vitamina A.
English: For the full list of all side effects reported with Panretin, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Panretin potražite u uputi o lijeku.
English: The most common side effects with Panretin (which may affect more than 1 patient in 10) are rash, pruritus (itching), skin disorders (cracking, scabbing, crusting, draining, oozing) and pain (burning, soreness).
Croatian: Najčešće nuspojave lijeka Panretin (koje se mogu javiti u više od 1 na 10 bolesnika) su osip, pruritus (svrbež), kožni poremećaji (ispucalost, hrapavost, kraste, vlaženje, gnojni iscjedak) i bol (žarenje, osjetljivost).
English: Elderly (≥65 years old)
Croatian: Starije osobe (≥ 65 godina)
English: Normally, this soon disappears.
Croatian: To obično brzo nestane.
English: Before opening: 2 years.
Croatian: Prije otvaranja: 2 godine.
English: ATC code: A10AD05.
Croatian: ATK oznaka: A10AD05.
English: These reactions are usually of a transitory nature.
Croatian: Te reakcije obično su prolazne naravi.
English: Your medicine might be harmful to their health.
Croatian: Vaš lijek mogao bi naškoditi njihovu zdravlju.
English: 10 people.
Croatian: 10 osoba.
English: Date of last renewal: 2 July 2010
Croatian: Datum posljednje obnove odobrenja: 2. srpnja 2010.
English: They must not give you any food or drink because you may choke.
Croatian: Oni Vam ne smiju davati nikakvu hranu ni piće zbog rizika od gušenja.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: (below 30°C) for up to 4 weeks.
Croatian: 30°C) do 4 tjedna.
English: Dose adjustments can be made once a week until target HbA1c is reached.
Croatian: Doza se može prilagođavati jednom tjedno dok se ne postigne ciljna vrijednost HbA1c.
English: • Repeatedly take less insulin than you need.
Croatian: • više puta zaredom primijenite manje inzulina nego što Vam je potrebno.
English: The duration of action is up to 24 hours (Figure 1).
Croatian: Djelovanje traje do 24 sata (Slika 1).
English: See Instructions for use.
Croatian: Vidjeti Upute za uporabu.
English: This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects).
Croatian: To može umanjiti rizik od stvaranja kvržica ili ulegnuća na koži (vidjeti dio 4. Moguće nuspojave).
English: Do not count the pen clicks.
Croatian: Nemojte brojati „klikove“ brizgalice.
English: You should always measure your blood sugar regularly.
Croatian: Uvijek valja redovito mjeriti razinu šećera u krvi.
English: Always keep your pen and needles out of sight and reach of others, especially children.
Croatian: Uvijek čuvajte svoju brizgalicu i igle izvan pogleda i dohvata drugih osoba, naročito djece.
English: If they do not disappear, see your doctor.
Croatian: Ako ne nestanu, posjetite liječnika.
English: The dose should not be increased if hypoglycaemia occurred within these days.
Croatian: Doza se ne smije povećavati ako se tih dana pojavila hipoglikemija.
English: The maximum effect is exerted between 1 and 4 hours after injection.
Croatian: Maksimalni učinak postiže se između 1 i 4 sata nakon injiciranja.
English: See the big picture on top of this instruction.
Croatian: Vidjeti veliku sliku na vrhu ovih uputa za uporabu.
English: This should be kept in mind if treatment with the combination of pioglitazone and NovoMix is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka NovoMix.
English: You can carry it with you and keep it at room temperature
Croatian: Možete ga nositi uza se i čuvati na sobnoj temperaturi (ispod
English: ► If you are going abroad, travelling over time zones may affect your insulin needs and the timing hereof.
Croatian: ► ako putujete u inozemstvo, putovanje kroz vremenske zone može utjecati na Vaše potrebe za inzulinom i na vrijeme injiciranja.
English: Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly).
Croatian: Nemojte nikada injicirati inzulin izravno u venu (intravenski) ili mišić (intramuskularno).
English: You cannot select a dose larger than the number of units left in the cartridge.
Croatian: Ne možete odabrati veću dozu od one koja je preostala u ulošku.
English: However, Cmax differed between the age groups, stressing the importance of the individual titration of insulin aspart.
Croatian: Međutim, Cmax se razlikovao po dobnim skupinama, što naglašava važnost individualne titracije aspart inzulina.
English: ► If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
Croatian: ► ako vježbate više no obično ili želite promijeniti uobičajenu prehranu, jer to može utjecati na razinu šećera u krvi.
English: Then titrate according to individual needs (see the titration guideline in the table above).
Croatian: Nakon toga dozu prilagodite individualnim potrebama bolesnika (vidjeti smjernice za titraciju u gornjoj tablici).
English: (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Croatian: Obavijestite liječnika, što je prije moguće, ako osjetite znakove zatajivanja srca kao što su neuobičajeni nedostatak zraka ili naglo povećanje tjelesne težine ili lokalizirano oticanje (edem).
English: ► If you suspect hypoglycaemia (low blood sugar) is starting, see a) Summary of serious and very common side effects in section 4.
Croatian: ► ako sumnjate da počinje hipoglikemija (niska razina šećera u krvi), vidjeti a) Sažetak ozbiljnih i vrlo čestih nuspojava u dijelu 4.
English: • Whenever the risk management system is modified, especially as the results of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • na zahtjev Europske agencije za lijekove; • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: • Forget to take your insulin or stop taking insulin.
Croatian: • zaboravite primijeniti inzulin ili prestanete primjenjivati inzulin.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving or operating a machine.
Croatian: Bolesnicima treba savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju tijekom vožnje ili rukovanja strojem.
English: Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Croatian: Neki lijekovi utječu na šećer u krvi, a to može značiti da će Vaša doza inzulina morati biti promijenjena.
English: Do not soak, wash or lubricate it as it may damage the pen.
Croatian: Nemojte je namakati, prati niti podmazivati jer to može oštetiti brizgalicu.
English: Limited clinical data exists for children aged 6-9 years.
Croatian: Ograničeni klinički podaci postoje za djecu u dobi od 6-9 godina.
English: If convenient, the gluteal or deltoid region may be used.
Croatian: može se injicirati u glutealnu ili deltoidnu regiju.
English: Subsequently, dosage should be adjusted individually.
Croatian: Posljedično, bolesnicima dozu treba individualno prilagoditi.
English: Check the name and coloured label of your pen to make sure that it contains the correct type of insulin.
Croatian: Provjerite naziv i boju naljepnice na Vašoj brizgalici kako biste bili sigurni da sadrži odgovarajuću vrstu inzulina.
English: The following titration guideline is recommended for dose adjustments:
Croatian: Za prilagodbu doze preporučene su sljedeće smjernice za titraciju:
English: Intramuscular administration should be avoided.
Croatian: Treba izbjegavati intramuskularnu primjenu.
English: Needles are not included
Croatian: Igle nisu priložene.
English: After stabilisation of the patient's blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and
Croatian: Nakon što se bolesnikova razina glukoze u krvi stabilizira, treba razmotriti prilagodbu doze (vidjeti dijelove 4.2, 4.8 i 4.9).
English: ► For every following injection
Croatian: ► Za svako sljedeće injiciranje
English: ► Withdraw the needle from the skin, then release the pressure on the push-button.
Croatian: Izvucite iglu iz kože, a zatim otpustite potisni gumb.
English: This has a rapid onset of action, thus allowing it to be given closer to a meal (within zero to 10 minutes of the meal) when compared to soluble human insulin.
Croatian: što omogućuje primjenu bliže obroku (0 do 10 minuta od obroka) u usporedbi s otopinom humanog inzulina.
English: It may affect more than 1 in
Croatian: Može se javiti u više od 1 na
English: 12 units are marked on the residual scale.
Croatian: 12 jedinica je označeno na skali preostalog inzulina.
English: If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar level.
Croatian: Ako se izbornik doze zaustavi prije nego što dođe do '0', nije primijenjena cijela doza, zbog čega bi razina šećera u krvi mogla postati previsoka.
English: • Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional.
Croatian: • Teške epizode hipoglikemije, u kojima bolesnik ostane bez svijesti, mogu se liječiti glukagonom (0,5 do 1 mg) koji intramuskularno ili supkutano daje osoba upoznata s načinom primjene glukagona, ili glukozom koju intravenski daje zdravstveni radnik.