FrancophonIA/ELRC3.0 huggingface dataset:
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Croatian: Jedna pojedinačna inhalacija daje primijenjenu dozu (doza koja izlazi iz nastavka za usta) od 92 mikrograma flutikazonfuroata i 22 mikrograma vilanterola (u obliku trifenatata).
English: Tlf: + 45 36 35 91 00 dk-info@gsk.com
Croatian: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/vilanterol
Croatian: Revinty Ellipta 92 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/vilanterol
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/929/006
English: Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Croatian: Uputa o lijeku: Informacije za korisnika Revinty Ellipta 92 mikrograma/22 mikrograma prašak inhalata, dozirani Revinty Ellipta 184 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/vilanterol
English: NAME OF THE MEDICINAL PRODUCT Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Croatian: Revinty Ellipta 184 mikrograma/22 mikrograma prašak inhalata, dozirani flutikazonfuroat/vilanterol
English: Subjects were then randomized to receive either fluticasone furoate/vilanterol 92/22 micrograms, fluticasone furoate 92 micrograms, vilanterol 22 micrograms, or placebo, and treated for a mean of 1.7 years (SD = 0.9 years).
Croatian: Ispitanici su potom randomizirani za primanje flutikazonfuroata/vilanterola od 92/22 mikrograma, flutikazonfuroata od 92 mikrograma,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/929/001
English: Use this medicine for as long as your doctor recommends.
Croatian: obratite se svom liječniku što je prije moguće.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/929/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/929/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/929/003
English: Tel: + 385 1 6051 999
Croatian: GlaxoSmithKline d.o.o. Tel: + 385 1 6051 999
English: Further information on Libtayo can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Croatian: Više informacija o lijeku Libtayo dostupno je na internetskim stranicama Agencije: www.ema.europa.eu/medicines/human/EPAR/libtayo.
English: The recommended dose is 350 mg once every 3 weeks.
Croatian: Preporuča se jedna doza od 350 mg svaka tri tjedna.
English: However, the study involved a small number of patients and additional data are required.
Croatian: Međutim, u ispitivanje je bio uključen mali broj bolesnika te su potrebni dodatni podatci.
English: Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.
Croatian: Liječenje se može nastaviti sve dok je bolest stabilna i dok se kod bolesnika ne pojave neprihvatljive nuspojave.
English: In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received 350 mg Libtayo every 3 weeks for around one year.
Croatian: U glavnom ispitivanju koje je obuhvatilo 193 bolesnika rak se smanjio u oko 39 % bolesnika s metastatskom bolesti koji su primali 350 mg lijeka Libtayo svaka tri tjedna u razdoblju od otprilike godine dana.
English: The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Croatian: Tvrtka će također istražiti djeluje li lijek drugačije s obzirom na razinu PD-L1 koji proizvode stanice raka.
English: What is Libtayo and what is it used for?
Croatian: Što je Libtayo i za što se koristi?
English: Among patients with locally advanced disease who received Libtayo every 2 weeks (at a dose of 3 mg/kg bodyweight) for around 2 years, 44% of patients showed shrinkage of their cancer.
Croatian: Među bolesnicima s lokalno uznapredovalom bolesti koji su primali lijek Libtayo svaka 2 tjedna (u dozi od 3 mg/kg tjelesne težine) u razdoblju od oko dvije godine, u 44 % bolesnika utvrđeno je smanjenje raka.
English: Libtayo has been given ‘conditional authorisation'.
Croatian: Za lijek Libtayo izdano je „uvjetno odobrenje”.
English: Libtayo is given as an infusion (drip) into a vein lasting 30 minutes.
Croatian: Libtayo se primjenjuje intravenskom infuzijom (ukapavanjem) u trajanju od 30 minuta.
English: As for the medicine's safety, its side effects are manageable and similar to those seen in other cancer treatments of this type.
Croatian: Kad je riječ o sigurnosti primjene lijeka, njegove nuspojave mogu se kontrolirati i slične su onima za druge terapije te vrste protiv raka.
English: What measures are being taken to ensure the safe and effective use of Libtayo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Libtayo?
English: The European Medicines Agency therefore decided that Libtayo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Libtayo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: It is used in patients who cannot have surgery or treatment with radiation to cure their disease.
Croatian: Koristi se u bolesnika u kojih bolest nije moguće liječiti kirurškim zahvatom ili zračenjem.
English: The doctor may need to delay doses if certain side effects occur, or stop treatment altogether if side effects are severe.
Croatian: Liječnik će možda morati odgoditi primjenu doze ako nastupe određene nuspojave ili u potpunosti prekinuti liječenje kod težih nuspojava.
English: Treatment with Libtayo must be started and supervised by a doctor experienced in treating cancer.
Croatian: Liječenje lijekom Libtayo mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
English: Side effects reported with Libtayo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Libtayo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common immune-related effects (which may affect up to 1 in 10 people) were hypothyroidism (an underactive thyroid gland with tiredness, weight gain, and skin and hair changes), pneumonitis (inflammation in the lungs causing shortness of breath and cough), skin reactions, hyperthyroidism (an overactive thyroid gland which can cause hyperactivity, sweating, weight loss and thirst) and hepatitis (inflammation of the liver).
Croatian: Najčešće nuspojave povezane s imunosnim sustavom (koje se mogu javiti u najviše 1 na 10 osoba) su hipotireoza (nedovoljno aktivna štitnjača, umor, dobivanje na težini, promjene na koži i kosi), pneumonitis (upala pluća koja uzrokuje nedostatak zraka i kašalj), kožne reakcije, hipertireoza (prekomjerno aktivna štitnjača koja može uzrokovati hiperaktivnost, znojenje, gubitak težine i žeđ) te hepatitis (upala jetre).
English: Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
Croatian: Libtayo je lijek protiv raka koji se koristi za liječenje odraslih osoba oboljelih od oblika raka kože naziva karcinom skvamoznih stanica kože kada je rak lokalno uznapredovao (proširio se u okolno tikvo) ili metastazirao (proširio se na druge dijelove tijela).
English: The company that markets Libtayo will provide a guide and an alert card for patients with information on the signs and symptoms of immune-related side effects of the medicine, as well as instructions on contacting their doctor if they experience symptoms.
Croatian: Tvrtka koja stavlja lijek Libtayo u promet dostavit će vodič i karticu s upozorenjima namijenjenu bolesnicima s informacijama o znakovima i simptomima nuspojava lijeka povezanih s imunosnim sustavom, kao i uputu da se jave svojem liječniku u slučaju pojave simptoma.
English: Libtayo is associated with side effects related to the activity of the immune system, which can be serious, although most side effects go away with appropriate treatment or on stopping Libtayo.
Croatian: Nuspojave lijeka Libtayo povezane su s djelovanjem imunosnog sustava i mogu biti ozbiljne, iako većina nuspojava nastaje uz odgovarajuću terapiju ili nakon prekida liječenja lijekom Libtayo.
English: Other information about Libtayo
Croatian: Ostale informacije o lijeku Libtayo
English: Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Croatian: Stanice raka mogu proizvesti bjelančevine (PD-L1 i PD-L2) koje se vežu na taj receptor i prekidaju aktivnost T-stanica, čime ih sprječavaju da napadaju rak.
English: As for all medicines, data on the use of Libtayo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Libtayo kontinuirano se prate.
English: Why is Libtayo authorised in the EU?
Croatian: Zašto je lijek Libtayo odobren u EU-u?
English: An overview of Libtayo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Libtayo i zašto je odobren u EU-u
English: Since Libtayo has been given conditional authorisation, the company that markets Libtayo will provide data from an ongoing study on the effectiveness and safety of the medicine for cutaneous squamous cell carcinoma.
Croatian: Budući da je lijek Libtayo dobio uvjetno odobrenje, tvrtka koja stavlja lijek Libtayo u promet mora dostaviti podatke iz ispitivanja koje je u tijeku o učinkovitosti i sigurnosti primjene lijeka za karcinom skvamoznih stanica kože.
English: By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Croatian: Vezivanjem na receptor cemiplimab sprječava da PD-L1 i PD-L2 prekinu aktivnost T-stanica, čime se povećava sposobnost imunosnog sustava da ubija stanice raka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Libtayo have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Libtayo nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Severe reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals) have been reported with Libtayo.
Croatian: Pri primjeni lijeka Libtayo prijavljene su ozbiljne reakcije, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu (po život opasne reakcije sa simptomima nalik gripi i bolnim osipom koji zahvaća kožu, usta, oči i genitalije).
English: What are the risks associated with Libtayo?
Croatian: Koji su rizici povezani s lijekom Libtayo?
English: How does Libtayo work?
Croatian: Kako djeluje Libtayo?
English: For more information about using Libtayo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Libtayo pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Libtayo is effective at treating cutaneous squamous cell carcinoma, a cancer with few treatment options once it has spread.
Croatian: Libtayo je učinkovit u liječenju karcinoma skvamoznih stanica kože, raka s vrlo ograničenim mogućnostima liječenja nakon što proširi.
English: The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Croatian: Djelatna tvar lijeka Libtayo, cemiplimab, monoklonsko je protutijelo, tj. vrsta bjelančevine osmišljene za prepoznavanje određenog receptora (ciljnog mjesta) naziva PD-1, koji se nalazi na površini određenih stanica imunosnog sustava naziva T-stanice, i vezivanje na njega.
English: What information is still awaited for Libtayo?
Croatian: Koje se još informacije očekuju o lijeku Libtayo?
English: What benefits of Libtayo have been shown in studies?
Croatian: Koje su koristi od lijeka Libtayo utvrđene u ispitivanjima?
English: Libtayo is effective at treating cutaneous squamous cell carcinoma in many patients.
Croatian: Libtayo je u mnogih bolesnika učinkovit u liječenju karcinoma skvamoznih stanica kože.
English: Libtayo contains the active substance cemiplimab.
Croatian: Libtayo sadrži djelatnu tvar cemiplimab.
English: For the full list of side effects and restrictions with Libtayo, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Libtayo potražite u uputi o lijeku.
English: Please discuss with your doctor if you have further questions.
Croatian: Molimo razgovarajte sa svojim liječnikom ako imate dodatnih pitanja.
English: The carcinogenic potential was not evaluated.
Croatian: Karcinogeni potencijal nije procijenjen.
English: This has been shown in studies in animals and in laboratory studies.
Croatian: To je dokazano u ispitivanjima na životinjama i u laboratorijskim ispitivanjima.
English: This medicine is a muscle relaxant.
Croatian: Ovaj lijek je mišićni relaksans.
English: [*For the printed material, please refer to the guidance of the annotated QRD template.]
Croatian: [*Za tiskani materijal, molimo pogledajte smjernice naznačenog QRD predloška.]
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako vam je rekao vaš liječnik ili ljekarnik.
English: This is because the medicine passes into your breast-milk.
Croatian: To je zato što lijek prelazi u vaše majčino mlijeko.
English: Do not exceed the recommended doses and treatment duration.
Croatian: Nemojte prekoračiti preporučene doze i trajanje liječenja.
English: The dose without toxic effect was 3 mg/kg/day.
Croatian: Doza bez toksičnog učinka bila je 3 mg/kg/dan.
English: Studies in animals have shown teratogenic effects (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su teratogene učinke (vidjeti dio 5.3).
English: The treatment duration is limited to 5 consecutive days.
Croatian: Trajanje liječenja ograničeno je na 5 uzastopnih dana.
English: Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.
Croatian: Bolesnike se mora pažljivo informirati o potencijalnim rizicima moguće trudnoće i o djelotvornim mjerama kontracepcije koje je potrebno poduzeti.
English: The treatment duration is limited to 7 consecutive days.
Croatian: Trajanje liječenja ograničeno je na 7 uzastopnih dana.
English: This is based on laboratory studies (see section 2 “Warnings and precautions”).
Croatian: Ovo se temelji na laboratorijskim ispitivanjima (pogledajte dio 2 „Upozorenja i mjere opreza”).
English: Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy.
Croatian: Vaš će vas liječnik informirati o svim mjerama koje su povezane s učinkovitom kontracepcijom i o potencijalnim rizicima kod trudnoće.
English: Furthermore, minor abnormalities have been observed (supernumerary ribs, retarded ossification).
Croatian: Nadalje, opažene su manje abnormalnosti (prekobrojna rebra, zakašnjela osifikacija).
English: Strictly respect the doses and duration of treatment detailed in section 3.
Croatian: Strogo poštujte doze i trajanje liječenja kako je navedeno u dijelu 3.
English: You should not use this medicine at higher dose or for longer than 7 days (for oral forms)/5 days (for IM forms).
Croatian: Ne smijete uzimati ovaj lijek u većim dozama ili dulje od 7 dana (kod oblika lijeka za primjenu kroz usta)/5 dana (kod oblika lijeka za primjenu u mišić).
English: [this wording should be inserted]
Croatian: [Mora se unijeti ovaj tekst]
English: - After oral administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20%.
Croatian: - Nakon peroralne primjene, ukupna radioaktivnost je većinom izlučena u stolicu (79%), dok se putem mokraće izluči tek 20%.
English: There are limited data on the use of thiocolchicoside in pregnant women.
Croatian: Postoje ograničeni podaci o primjeni tiokolhikozida u trudnica.
English: [the currently approved indications should be deleted and replaced by the following]
Croatian: [trenutno odobrene indikacije moraju se obrisati i zamijeniti sljedećim]
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.
English: [This wording should be inserted] This medicine is subject to additional monitoring.
Croatian: [mora se unijeti donji tekst] Ovaj je lijek pod dodatnim praćenjem.
English: 4 mg/2 ml [up to 10] vials/ampoules
Croatian: 4 mg/2 ml [do 10] bočica/ampula
English: Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards.
Croatian: Adjuvantno liječenje bolnih kontraktura mišića kod akutne spinalne patologije u odraslih i adolescenata u dobi od 16 godina i starijih.
English: The corresponding values of AUC are respectively 283 and 417 ng.h/mL.
Croatian: Odgovarajuće AUC vrijednosti su 283 odnosno 417 ng.h/mL.
English: Paediatric population <Invented name> should not be used in children and adolescents under 16 years of age because of safety concerns (see section 5.3).
Croatian: Pedijatrijska populacija <Zaštićeno ime> se, iz sigurnosnih razloga, ne smije primjenjivati u djece i adolescenata mlađih od 16 godina (vidjeti dio 5.3).
English: o For intramuscular form:
Croatian: o Oblici za intramuskularnu primjenu:
English: 4 mg [up to 30] hard capsules [up to 30] tablets
Croatian: 4 mg [do 30] tvrdih kapsula [do 30] tableta
English: This is because one of the products formed in your body when taking thiocolchicoside at high doses might cause damage to some cells (abnormal number of chromosomes).
Croatian: To je zato što jedan od produkata koji se stvara u vašem tijelu kad uzimate tiokolhikozid u većim dozama može oštetiti neke stanice (abnormalni broj kromosoma).
English: For both metabolites, maximum plasma concentrations occur 1hour after thiocolchicoside administration.
Croatian: Za oba metabolita, maksimalne koncentracije u plazmi dosegnute su 1 sat nakon primjene tiokolhikozida.
English: 4.6 Fertility, pregnancy and lactation [the currently approved wording should be deleted and replaced by the following]
Croatian: 4.6 Plodnost, trudnoća i dojenje [trenutno odobreni tekst mora se obrisati i zamijeniti sljedećim]
English: Therefore, the potential hazards for the embryo and foetus are unknown.
Croatian: Prema tome, potencijalni rizici za zametak i plod nisu poznati.
English: This medicine should not be used for long-term treatment (see section 2 “Warnings and precautions”).
Croatian: Ovaj se lijek ne smije koristiti za dugotrajno liječenje (pogledajte dio 2 „Upozorenja i mjere opreza”).
English: Do not give this medicine to children and adolescents below 16 years old because of safety concerns.
Croatian: Iz sigurnosnih razloga, nemojte davati ovaj lijek djeci i adolescentima mlađim od 16 godina.
English: No data are available for the inactive metabolite SL59.0955.
Croatian: Nema raspoloživih podataka za neaktivni metabolit SL59.0955.
English: How to take X [the currently approved wording should be deleted and replaced by the following]
Croatian: Kako uzimati X [trenutno odobreni tekst mora se obrisati i zamijeniti sljedećim]
English: Since it passes into the mother's milk, the use of thiocolchicoside is contraindicated during breastfeeding (see section 4.3).
Croatian: Budući da prolazi u majčino mlijeko, primjena tiokolhikozida kontraindicirana je za vrijeme dojenja (vidjeti dio 4.3).
English: This step mainly occurs by intestinal metabolism explaining the lack of circulating unchanged thiocolchicoside by this route of administration.
Croatian: To se uglavnom događa intestinalnim metabolizmom što objašnjava nedostatak cirkulirajućeg nepromijenjenog tiokolhikozida kod ovog puta primjene.
English: Method of administration [To be completed nationally]
Croatian: Način primjene [Popuniti u svakoj zemlji posebno]
English: It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions.
Croatian: Primjenjuje se kod odraslih i adolescenata u dobi od 16 godina i starijih kao adjuvantno liječenje bolnih mišićnih kontrakcija.
English: - After oral administration, no thiocolchicoside is detected in plasma.
Croatian: - Nakon peroralne primjene, nije detektiran tiokolhikozid u plazmi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for capsules, hard /tablets/orodispersible tablets and solution for injection
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjsko pakiranje za tvrde kapsule/ tablete/raspadljive tablete za usta i otopinu za injekciju
English: Do not take this medicine if: - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception
Croatian: Nemojte uzeli ovaj lijek ako: - ste trudni, ako biste mogli biti trudni ili mislite da ste trudni, - ste žena u fertilnoj dobi i ne koristite kontracepciju.
English: It is to be used for acute conditions related to spinal column.
Croatian: Primjenjuje se kod akutnih stanja povezanih s kralješnicom.
English: You can also report side effects directly via {the national reporting system listed in Appendix V}*.
Croatian: Nuspojave možete prijaviti izravno putem {nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V}*.
English: SL59.0955 is also demethylated into didemethyl-thiocolchicine.
Croatian: SL59.0955 se također demetilira u didemetil-tiokolhicin.
English: For SL59.0955 these values are much lower: Cmax around 13 ng/mL and AUC ranging from 15.5 ng.h/mL (until 3h) to 39.7 ng.h/mL (until 24h).
Croatian: Za SL59.0955, te su vrijednosti puno niže: Cmax iznosi oko 13 ng/mL dok je AUC u rasponu od 15,5 ng.h/mL (do 3h) do 39,7 ng.h/mL (do 24h).
English: This medicine might cause problems to the male fertility due to potential damage to sperm cells (abnormal number of chromosomes).
Croatian: Ovaj lijek može uzrokovati probleme u muškoj plodnosti radi mogućeg oštećenja spermatozoida (abnormalni broj kromosoma).
English: Thiocolchicoside was well tolerated following oral administration for periods of up to 6 months in both the rat and the non-human primate when administered at repeated doses of less than or equal to 2 mg/kg/day in the rat and less or equal to 2.5 mg/kg/day in non-human primate, and by the intramuscular route in the primate at repeated doses up to 0.5 mg/kg/day for 4 weeks.
Croatian: Tiokolhikozid se dobro podnosio nakon peroralne primjene tijekom razdoblja do 6 mjeseci kod štakora i nečovjekolikih primata kad se primjenjivao u ponovljenim dozama manjim ili jednakim 2 mg/kg/dan kod štakora i manjim ili jednakim 2,5 mg/kg/dan kod nečovjekolikih primata, te intramuskularnim putem kod primata u ponovljenim dozama do 0,5 mg/kg/dan tijekom 4 tjedna.
English: o For the oral form 4 mg and 8 mg:
Croatian: Doziranje o Oblici za peroralnu primjenu od 4 mg i 8 mg:
English: PL
Croatian: o
English: 8 mg [up to 14] hard capsules [up to14] orodispersible tablets
Croatian: 8 mg [do 14] tvrdih kapsula [do14] raspadljivih tableta za usta