natgillin/translations-raw huggingface dataset:
Subjects were grouped according to baseline creatinine clearance (> 80 mL/min as normal function; 50-80 mL/min as mild impairment; 30-49 mL/min as moderate impairment; < 30 mL/min as severe impairment; < 15 mL/min as functionally anephric requiring haemodialysis).
Ispitanici su bili grupirani prema početnom klirensu kreatinina (normalna funkcija pri > 80 mL/min, blago oštećenje pri 50-80 mL/min, umjereno oštećenje pri 30-49 mL/min, teško oštećenje pri < 30 mL/min i bez funkcije bubrega uz potrebnu hemodijalizu pri
• If you have both HIV infection and hepatitis B, it is especially important not to stop your
• Ako imate istovremenu infekciju HIV-om i hepatitis B, naročito je važno da se ne prestanete liječiti Emtrivom, a da prije toga niste razgovarali s liječnikom.
Adults with renal insufficiency
Odrasli pacijenti s insuficijencijom bubrega
Assessment of adverse reactions in paediatric patients from clinical study data is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
temelji se na iskustvima prikupljenima tijekom tri pedijatrijska ispitivanja (n = 169), provedenima na pedijatrijskim pacijentima inficiranima HIV-om u dobi od 4 mjeseca do 18 godina, koji nisu bili prethodno liječeni (n = 123) i koji su već liječeni (n = 46), a koji su tijekom ispitivanja liječeni emtricitabinom u kombinaciji s drugim antiretrovirusnim lijekovima.
Package leaflet: Information for the user Emtriva 200 mg hard capsules
Uputa o lijeku: Informacije za korisnika Emtriva 200 mg tvrde kapsule emtricitabin
You do not need to take another dose if you were sick more than an hour after taking Emtriva.
Drugu dozu ne trebate uzimati ako ste povraćali nakon što je prošlo više od jednog sata po uzimanju Emtrive.
In an open-label, non-comparative study, pharmacokinetic data were obtained from 20 neonates of HIV infected mothers who received two 4-day courses of emtricitabine oral solution between the first week of life and 3 months of age at a dose level of 3 mg/kg once daily.
20 novorođenčadi majki inficiranih HIV-om koji su primali 4-dnevnu terapiju oralne otopine emtricitabina između prvog tjedna života i 3 mjeseca starosti u dozama od 3 mg/kg jedanput na dan.
If you stop taking Emtriva • Don't stop taking Emtriva without talking to your doctor.
• Nemojte prestati uzimati Emtrivu bez prethodnog razgovora s liječnikom.
Discontinuation of Emtriva therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Prekid terapije Emtrivom u pacijenata istovremeno inficiranih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa (vidjeti dio 4.4).
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Stoga se u tih pacijenata moraju pomno pratiti klinički odgovor na liječenje i funkcija bubrega (vidjeti dio 4.4).
Emtricitabine did not exhibit cytotoxicity to peripheral blood mononuclear cells (PBMCs), established lymphocyte and monocyte-macrophage cell lines or bone marrow progenitor cells in vitro.
Nije se pokazala citotoksičnost emtricitabina na mononuklearne stanice periferne krvi (PBMC), utvrđene linije stanica limfocita te monocita-makrofaga ni na tvorne stanice koštane srži in vitro.
The cup has lines to indicate each mL of solution.
Na čašici je crtama označen svaki mL otopine.
4.9 Overdose
Dodatku V. 4.9 Predoziranje
Adults: The recommended dose of Emtriva 10 mg/mL oral solution is 240 mg (24 mL) once daily.
Odrasli: Preporučena doza Emtriva 10 mg/mL oralne otopine je 240 mg (24 mL), a uzima se jedanput na dan.
Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza oznake
The systemic emtricitabine exposure (mean ± standard deviation) increased from 11.8 ± 2.9 µg·h/mL in subjects with normal renal function to 19.9 ± 1.1, 25.0 ± 5.7 and 34.0 ± 2.1 µg·h/mL, in patients with mild, moderate and severe renal impairment, respectively.
11,8 ± 2,9 µg·h/mL u ispitanika s normalnom funkcijom bubrega na 19,9 ± 1,1 µg·h/mL u pacijenata s blagim oštećenjem funkcije bubrega, 25,0 ± 5,7 µg·h/mL u pacijenata s umjerenim oštećenjem funkcije bubrega i 34,0 ± 2,1 µg·h/mL u pacijenata s teškim oštećenjem funkcije bubrega.
Gilead Sciences, Lda.
Portugal Gilead Sciences, Lda.
Use the measuring cup provided in the carton to measure the correct dose.
Da biste izmjerili točnu dozu, koristite mjernu čašicu koja se isporučuje u pakiranju.
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin),
• osipi (uključujući crvene točkice ili mrlje, katkada s pojavom mjehurića i oticanjem kože), koji mogu biti alergijske reakcije, svrbež, promjene boje kože, uključujući tamnjenje dijelova kože
If Emtriva is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Ako se prekine liječenje Emtrivom u pacijenata koji su istovremeno inficirani HIV-om i virusom hepatitisa B (HBV), te je pacijente nužno pomno nadzirati zbog pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
Immune system disorders: Common:
Poremećaji imunološkog sustava:
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and dialysate flow rate of approximately 600 mL/min).
U pacijenata na hemodijalizi, s bubrežnom bolešću u završnoj fazi (ESRD), u dijalizatu je izolirano približno 30% doze emtricitabina tijekom trosatne dijalize započete u roku od 90 minuta od doziranja emtricitabinom (brzina protoka krvi od 400 mL/min i brzina protoka dijalizata od približno 600 mL/min).
Resistance: HIV-1 resistance to emtricitabine develops as the result of changes at codon 184 causing the methionine to be changed to a valine (an isoleucine intermediate has also been observed) of the HIV reverse transcriptase.
Rezistencija: Rezistencija virusa HIV-1 na emtricitabin razvija se kao rezultat promjena kodona 184
Emtriva contains the active substance emtricitabine.
Emtriva sadrži djelatnu tvar emtricitabin.
Gilead Sciences, S.L.
España Gilead Sciences, S.L.
Additionally, in a second study, treatment-experienced adults on a stable PI-based highly active antiretroviral therapy (HAART) regimen were randomised to a once daily regimen containing emtricitabine or to continue with their PI-HAART regimen.
Tijekom dodatnog ispitivanja, odrasli pacijenti koji su prethodno liječeni te primaju visoko aktivno antiretrovirusno liječenje (HAART, highly active antiretroviral therapy) na temelju stabilnog inhibitora proteaze, slučajnim odabirom razvrstani su u dvije skupine: u jednoj su pacijenti liječeni režimom koji sadrži emtricitabin jedanput na dan, a u drugoj je nastavljena HAART-terapija inhibitorom proteaze.
Per day
Na dan
Gilead Sciences Poland Sp. z o.o.
Polska Gilead Sciences Poland Sp. z o.o.
Table 1 below provides daily doses of Emtriva 10 mg/mL oral solution according to the degree of renal insufficiency.
U tablici 1 u nastavku navedene su dnevne doze Emtriva 10 mg/mL oralne otopine prema stupnju insuficijencije bubrega.
The recommended dose is: • Adults: one 200 mg hard capsule, each day with or without food.
• Odrasli: jedna tvrda kapsula od 200 mg svaki dan s hranom ili bez nje.
Recommended dose interval for 200 mg hard capsules
Preporučeni interval doziranja tvrdih kapsula od 200 mg
Exacerbations of hepatitis after discontinuation of treatment: In HIV infected patients co-infected with HBV, exacerbations of hepatitis may occur after discontinuation of treatment (see section 4.4).
Egzacerbacija hepatitisa nakon prekida liječenja: U pacijenata s HIV-om i istovremenom infekcijom HBV-om nakon prekida liječenja može doći do pogoršanja hepatitisa (vidjeti dio 4.4).
One 200 mg hard capsule every 96 hours
200 mg svakih 96 sati
Patients with chronic hepatitis B or C infection treated with CART are at increased risk of experiencing severe, and potentially fatal, hepatic adverse events.
Pacijenti s kroničnom infekcijom hepatitisom B ili C liječeni kombiniranom antiretrovirusnom terapijom izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
Nervous system disorders: Very common:
Poremećaji živčanog sustava:
In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a protease inhibitor (PI) or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/mL) through 48 weeks (77% emtricitabine, 82% lamivudine).
U virološki stabilnih odraslih pacijenata koji su prethodno liječeni pokazalo se da emtricitabin u kombinaciji s NRTI-jem (stavudinom ili zidovudinom) i inhibitorom proteaze ili NNRTI-jem nema slabije djelovanje od lamivudina u pogledu udjela respondera (< 400 kopija/mL) tijekom 48 tjedana
Emtriva has not been studied in patients over the age of 65.
Emtriva nije ispitana u pacijenata starijih od 65 godina.
Emtriva oral solution can be taken with or without food.
Oralna otopina Emtriva može se uzimati s hranom ili bez nje.
Each Emtriva hard capsule contains 200 mg of emtricitabine.
Svaka tvrda kapsula Emtrive sadrži 200 mg emtricitabina.
Package leaflet: Information for the user Emtriva 10 mg/mL oral solution
Uputa o lijeku: Informacije za korisnika Emtriva 10 mg/mL oralna otopina emtricitabin
Emtriva 200 mg hard capsules Emtricitabine
Emtriva 200 mg tvrde kapsule emtricitabin
Method of administration Emtriva 200 mg hard capsules should be taken once daily, orally with or without food.
Način primjene Emtriva 200 mg tvrde kapsule valja uzimati peroralno s hranom ili bez nje jedanput na dan.
Emtriva hard capsules have a white opaque body with a light blue opaque cap. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink.
Na zatvaraču svake kapsule nalazi se natpis “200 mg”, a na tijelu “GILEAD” i [logotip Gilead] tiskan crnom tintom.
Emtriva 10 mg/mL oral solution
Emtriva 10 mg/mL oralna otopina
You do not need to take another capsule if you were sick more than an hour after taking Emtriva.
Drugu kapsulu ne trebate uzimati ako ste povraćali nakon što je prošlo više od jednog sata po uzimanju
Emtriva 10 mg/mL oral solution may be taken with or without food.
Emtriva 10 mg/mL oralna otopina može se uzimati s hranom ili bez nje.
België/Belgique/Belgien
België/Belgique/Belgien Gilead Sciences Belgium SPRL-BVBA
Emtriva 200 mg hard capsules
Emtriva 200 mg tvrde kapsule
Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.
Emtricitabin je slabi inhibitor DNK polimeraza α, β i ε te mitohondrijske DNK polimeraze γ u sisavaca.
No human data on the effect of emtricitabine are available.
Nema podataka o učinku emtricitabina na plodnost u čovjeka.
Elderly: Emtriva has not been studied in patients over the age of 65.
Stariji pacijenti: Emtriva se nije ispitivala u pacijenata starijih od 65 godina.
Musculoskeletal and connective tissue disorders: Very common:
Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
General disorders and administration site conditions: Common:
Opći poremećaji i reakcije na mjestu primjene:
Emtriva 10 mg/mL oral solution Emtricitabine
Emtriva 10 mg/mL oralna otopina emtricitabin
Emtriva [outer packaging only]
16. PODACI NA BRAILLEOVOM PISMU Emtriva [samo vanjsko pakiranje]
Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water
propilenglikol propilparahidroksibenzoat (E216) natrijev hidroksid natrijev dihidrogenfosfat hidrat boja sunset yellow (E110) pročišćena voda ksilitol (E967)
In addition to the adverse reactions experienced by adults, anaemia and skin discolouration occurred more frequently in clinical trials involving HIV infected paediatric patients (see section 4.8).
Uz nuspojave u odraslih, klinička ispitivanja na pedijatrijskoj populaciji inficiranoj HIV-om pokazala su češću pojavu anemije i promjenu boje kože (vidjeti dio 4.8).
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 mL) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Zbog razlike u biološkoj dostupnosti emtricitabina u tvrdim kapsulama i u oralnoj otopini, 240 mg (24 mL) emtricitabina primijenjenog kao oralna otopina trebalo bi imati jednaki učinak na koncentraciju u plazmi kao jedna tvrda kapsula s 200 mg emtricitabina (vidjeti dio 5.2).
Each hard capsule contains 200 mg of emtricitabine.
Jedna tvrda kapsula sadrži 200 mg emtricitabina.
Gilead Sciences Slovakia s.r.o.
Slovenská republika Gilead Sciences Slovakia, s.r.o.
Emtriva 10 mg/mL oral solution should be taken once daily, orally with or without food.
Emtriva 10 mg/mL oralnu otopinu valja uzimati peroralno s hranom ili bez nje jedanput na dan.
If the patient vomits within 1 hour of taking Emtriva, another dose should be taken.
U slučaju da pacijent povraća, a prošlo je manje od 1 sata od uzimanja Emtrive, treba uzeti drugu dozu.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with a reduced dose of emtricitabine (see sections 4.2 and 5.2).
Stoga je u pacijenata koji se liječe smanjenom dozom emtricitabina, nužno pažljivo pratiti klinički odgovor na liječenje i funkciju bubrega (vidjeti dijelove 4.2 i 5.2).
Emtricitabine exposure may be markedly increased in patients with severe renal insufficiency (creatinine clearance < 30 mL/min) receiving daily doses of 200 mg emtricitabine as hard capsules or 240 mg as the oral solution.
U pacijenata s teškom insuficijencijom bubrega (klirens kreatinina < 30 mL/min) koji primaju dnevnu dozu od 200 mg emtricitabina u tvrdim kapsulama ili od 240 mg kao oralnu otopinu, može se znatno povećati izloženost emtricitabinu.
Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution.
Pročitajte sažetak opisa svojstava lijeka za Emtriva 10 mg/mL oralnu otopinu.
If you are sick (vomit) If it's less than an hour since you took Emtriva, take another capsule.
Ako je prošlo manje od jednog sata od kad ste uzeli Emtrivu, uzmite drugu kapsulu.
Gilead Sciences GesmbH Tel: + 43 1 260 830
Gilead Sciences Poland Sp. z o.o. Tel: + 48 22 262 8702
Gilead Sciences Ireland UC
Ireland Gilead Sciences Ireland UC
Consequently, either a dose interval adjustment (using Emtriva 200 mg hard capsules) or a reduction in the daily dose of emtricitabine (using Emtriva 10 mg/mL oral solution) is required in all patients with creatinine clearance < 30 mL/min.
Stoga je za sve pacijente s klirensom kreatinina < 30 mL/min nužno prilagoditi interval doziranja (prilikom primjene Emtriva 200 mg tvrdih kapsula) ili smanjiti dnevnu dozu emtricitabina (prilikom primjene Emtriva 10 mg/mL oralne otopine).
Due to this difference in bioavailability, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule.
Zbog razlike u bioraspoloživosti, 240 mg emtricitabina primijenjenog u obliku oralne otopine, trebalo bi postići razine u plazmi slične onima zabilježenima nakon primjene jedne tvrde kapsule od 200 mg emtricitabina.
Therefore, clinical response to treatment and renal function should be closely monitored in patients treated with emtricitabine at prolonged dosing intervals (see sections 4.2 and 5.2).
Stoga je u pacijenata koji se liječe emtricitabinom u produljenom intervalu doziranja, nužno pažljivo pratiti klinički odgovor na liječenje i funkciju bubrega (vidjeti dijelove 4.2 i 5.2).
Emtriva 200 mg hard capsules are only suitable for patients who weigh at least 33 kg. Emtriva oral solution is available for people who have difficulty in swallowing Emtriva hard capsules.
Emtriva 200 mg tvrde kapsule prikladne su samo za pacijente tjelesne težine od najmanje 33 kg.
Emtriva 200 mg hard capsules are available for adults, adolescents and children who weigh at least 33 kg and can swallow hard capsules.
Za odrasle, adolescente i djecu tjelesne mase od najmanje 33 kg koja mogu progutati tvrde kapsule,
Capsule shell: gelatin, indigotine (E132), titanium dioxide (E171) Printing ink containing: black iron oxide (E172), shellac (E904)
Ovojnica kapsule: želatina, indigotin (E132), titanijev dioksid (E171)
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Zbog razlike u bioraspoloživosti emtricitabina u tvrdim kapsulama i u oralnoj otopini, 240 mg emtricitabina primijenjenog kao oralna otopina trebalo bi imati jednaki učinak na koncentraciju u plazmi kao jedna tvrda kapsula s 200 mg emtricitabina (vidjeti dio 5.2).
Hrvatska
omaglica
Each capsule has a white opaque body with a light blue opaque cap, of dimensions 19.4 mm x 6.9 mm. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink.
Svaka se kapsula sastoji od neprozirnog bijelog tijela te svijetloplavog neprozirnog zatvarača dimenzija 19,4 mm x 6,9 mm.
Please refer to the Summary of Product Characteristics for Emtriva 200 mg hard capsules.
Pročitajte sažetak opisa svojstava lijeka za Emtriva 200 mg tvrde kapsule.
If you are sick (vomit)
Ako povraćate
One mL of Emtriva oral solution contains 10 mg of emtricitabine (10 mg/mL).
Jedan mL oralne otopine Emtriva sadrži 10 mg emtricitabina
What Emtriva is and what it is used for What you need to know before you take Emtriva How to take Emtriva
Što je Emtriva i za što se koristi
Emtriva should always be combined with other medicines to treat HIV infection.
HIV-om uvijek mora koristiti u kombinaciji s drugim lijekovima.
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/mL oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard capsules.
Emtriva 10 mg/mL oralne otopine približno 80% biološke dostupnosti Emtriva 200 mg tvrdih kapsula.
Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 999
Tel: + 353 (0) 214 825 999
In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials involving HIV infected paediatric patients.
Uz nuspojave zabilježene u odraslih, klinička ispitivanja na pedijatrijskoj populaciji zaraženoj HIV-om pokazala su češću pojavu anemije (9,5%) i promjenu boje kože (31,8%).
vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)1,2
vezikulobulozni osip, pustulozni osip, makulopapularni osip, drugi osip, pruritus,
One 200 mg hard capsule every 24 hours
200 mg svakih 24 sata
Magnesium stearate (E572) Microcrystalline cellulose (E460) Povidone (E1201)
mikrokristalična celuloza (E460)
This medicine contains 36 mg of sodium (main component of cooking/table salt) per 24 mL dose.This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
Ovaj lijek sadrži 36 mg natrija (glavni sastojak kuhinjske soli) u jednoj dozi od 24 mL.
There is a separate Package Leaflet for Emtriva 200 mg hard capsules.
Pročitajte sažetak opisa svojstava lijeka Emtriva 200 mg tvrdih kapsula.
Viruses resistant to zidovudine, didanosine and NNRTIs retained their sensitivity to emtricitabine (IC50= 0.002 µmol/l to 0.08 µmol/l).
Virusi rezistentni na zidovudin, didanozin i NNRTI zadržali su osjetljivost na emtricitabin
Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1888
Тел.: + 353 (0) 1 686 1888
Therefore, children who weigh at least 33 kg may take either one 200 mg hard capsule daily or the oral solution up to a maximum dose of 240 mg (24 mL), once daily.
200 mg dnevno ili oralnu otopinu do maksimalne doze od 240 mg (24 mL) jedanput na dan.
Methyl parahydroxybenzoate (E218) Propylene glycol
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari aroma šećerne vate dinatrijev edetat kloridna kiselina metilparahidroksibenzoat (E218)
Table 1 below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency.
U tablici 1 u nastavku navedene su smjernice za prilagodbu intervala doziranja tvrdih kapsula od
Within 3 months of Commission Decision
Unutar 3 mjeseca nakon odluke Komisije.
4. part III, pharmacovigilance plan: category 1 should be added for the PASS and the DUS.
4. Dio III., farmakovigilancijski plan: kategoriju 1. treba dodati za PASS i DUS.
This 5 years retrospective (new users) study will also compare the relative risk between dexamfetamine and other stimulants in the patient population.
Ovo 5godišnje retrospektivno ispitivanje (za nove korisnike) također će usporediti deksamfetamin i druge stimulanse u populaciji bolesnika.
The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Nadležna državna tijela koja koordinira referentna država članica pobrinut će se da nositelji odobrenja ispune sljedeće uvjete:
As part of this study the MAH shall actively obtain reports of abuse, misuse, diversion and dependence in children with ADHD from poison centres, drug monitoring centres, other databases, publicly available information in the literature and online.
Kao dio ovog ispitivanja nositelj odobrenja će aktivno prikupljati izvješća o zloporabi, pogrešnoj uporabi, diverziji i ovisnosti u djece s ADHD-om iz centara za kontrolu otrova, centara za praćenje lijekova, drugih baza podataka, javno dostupnih informacije u literaturi i na mreži.
The applicant shall submit an updated RMP taking into consideration the following recommendations: 1. section VI.2.5 Documentation for public summary should include a summary of risk minimisation measures by safety concern.
Podnositelj zahtjeva predati će ažurirani plan upravljanja rizicima uzimajući u obzir sljedeće preporuke: 1. Dio VI.2.5. Dokumentacije za javni sažetak treba uključivati sažetak mjera smanjivanja rizika zbog sigurnosne bojazni.
The applicant shall conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Podnositelj zahtjeva će provesti PASS-a kako bi se procijenio dugoročni profil sigurnosti deksamfetamina u djece s ADHD-om s posebnim naglaskom na ciljna, ključna pitanja poput kardiovaskularnih događaja, rasta i psihijatrijskih nuspojava.
3. annex 7: should include the text of a proposed follow up form to be used for specific adverse event follow-up.
3. Dodatak 7.: treba uključivati tekst predloženog obrasca praćenja koji će se koristiti za praćenje specifičnih nuspojava.
The applicant shall undertake a DUS to follow the use of prescribed dexamfetamine in the European Union using multiple data sources.
Nositelj odobrenja će poduzeti provedbu studije iskorištenja lijeka kako bi se pratila uporaba deksamfetamina u Europskoj uniji uporabom više izvora podataka.
2. annex 2 should include the proposed text of the package leaflet in addition to the proposed SmPC.
2. Dodatak 2. treba uključivati predloženi tekst Upute o lijeku pored predloženog Sažetka opisa svojstava lijeka.
Strength Pharmaceuti cal form
Farmaceutsk i oblik
(Invente d) name
(Zaštiće no) ime
Route of administratio n
Put primjene Unutarnje pakovanje
It is given once a week for the first 2 cycles and less frequently in subsequent cycles.
Daje se jedanput tjedno tijekom prva dva ciklusa i manje često u narednim ciklusima.
Treatment is given in 28-day cycles.
Terapija se daje u ciklusima od 28 dana.