FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir exposure in HBV infected paediatric patients 2 to < 12 years of age receiving an oral daily dose of tenofovir disoproxil 6.5 mg/kg of body weight (tablet or granules) up to a maximum dose of 245 mg was similar to exposures achieved in HIV-1 infected paediatric patients 2 to <12 years of age receiving a once daily dose of tenofovir disoproxil 6.5 mg/kg up to a maximum dose of tenofovir disoproxil 245 mg.
Croatian: Izloženost tenofoviru u pedijatrijskih bolesnika inficiranih HBV-om u dobi od 2 do < 12 godina koji su primali oralne dnevne doze tenofovirdizoproksila od 6,5 mg/kg tjelesne mase (u tabletama ili granulama) do najveće doze od 245 mg bila je slična izloženostima postignutima u pedijatrijskih bolesnika inficiranih virusom HIV-1 u dobi od 2 do <12 godina koji su primali jednu dnevnu dozu tenofovirdizoproksila od 6,5 mg/kg do najveće doze od 245 mg tenofovirdizoproksila.
English: i 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Croatian: i 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 144 tjedana otvorenog liječenja tenofovirdizoproksilom.
English: • HIV-1 infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Croatian: • djecu zaraženu virusom HIV-1 u dobi od 6 do manje od 12 godina, čija je tjelesna težina od 28 kg do manje od 35 kg i koja su već bila liječena drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije (otpornosti na lijek) ili su prouzročili nuspojave.
English: With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.
Croatian: vidjeti dijelove 4.2, 4.4, 4.8 i 5.1.
English: TDF
Croatian: Dob
English: • HIV-1 infected children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Croatian: • djecu zaraženu virusom HIV-1 u dobi od 6 do manje od 12 godina, čija je tjelesna težina od 22 kg do manje od 28 kg, i koja su već bila liječena drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije (otpornosti na lijek) ili su prouzročili nuspojave.
English: • HIV-1 infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Croatian: • djecu zaraženu virusom HIV-1 u dobi od 6 do manje od 12 godina, čija je tjelesna težina od 17 kg do manje od 22 kg i koja su već bila liječena drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije (otpornosti na lijek) ili su prouzročili nuspojave
English: Viread contains lactose
Croatian: Viread sadrži laktozu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/008 30 film-coated tablets EU/1/01/200/009 90 (3 bottles of 30) film-coated tablets
Croatian: EU/1/01/200/008 30 filmom obloženih tableta EU/1/01/200/009 90 (3 boce s 30) filmom obloženih tableta
English: This is because the active substance in this medicine passes into human breast milk.
Croatian: • Nemojte dojiti tijekom liječenja Vireadom, jer djelatna tvar u ovome lijeku prelazi u majčino mlijeko.
English: Renal impairment
Croatian: Viread granule
English: 288m 384o 96c 144f
Croatian: 96b 144e 192h 240j 288m 384o 96c 144f
English: l Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-TDF).
Croatian: l Prikazani brojevi su kumulativni postotci koji se temelje na Kaplan-Meierovoj analizi isključujući podatke prikupljene nakon dodavanja emtricitabina otvorenom liječenju tenofovirdizoproksilom (KM-tenofovirdizoproksil).
English: b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis.
Croatian: b Poboljšanje rezultata na Knodellovoj ljestvici nekroinflamatorne aktivnosti za najmanje dva boda bez pogoršanja na
English: i 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Croatian: i 48 tjedana dvostruko slijepog tenofovirdizoproksila nakon čega je slijedilo 192 tjedna otvorenog liječenja.
English: c 48 weeks double-blind tenofovir disoproxil followed by up to 192 weeks open-label.
Croatian: c 48 tjedana dvostruko slijepog tenofovirdizoproksila nakon čega je slijedilo 192 tjedna otvorenog liječenja.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu kod Vašeg djeteta, potrebno je obavijestiti liječnika Vašeg djeteta ili ljekarnika.
English: What Viread is and what it is used for What you need to know before your child takes Viread How to take Viread
Croatian: Što morate znati prije nego što Vaše dijete počne uzimati Viread Kako uzimati Viread
English: BMD Z-scorea
Croatian: Srednja vrijednost BMD Z-rezultataa cijelog tijela
English: The following side effects are common (these can affect up to 10 in every 100 patients):
Croatian: Sljedeće nuspojave su česte (mogu se javiti u do 10 na svakih 100 bolesnika): • vjetrovi
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Croatian: h 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 144 tjedana otvorenog liječenja tenofovirdizoproksilom.
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and on a randomised study (study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Croatian: Nuspojave su se procijenile na temelju jednog randomiziranog ispitivanja (ispitivanje GS-US-174-0115) u 106 adolescentnih bolesnika (u dobi od 12 do < 18 godina) s kroničnim hepatitisom B koji su primali liječenje tenofovirdizoproksilom u dozi od 245 mg (n = 52) ili placebo (n = 54) tijekom 72 tjedna te na randomiziranom ispitivanju (ispitivanje GS-US-174-0144) u
English: Each level dosing scoop provides 1 g of the granules which contains 33 mg tenofovir disoproxil (as fumarate).
Croatian: Jedna ravno napunjena mjerna žličica daje 1 g granula, koji sadrži 33 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Croatian: j 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 192 tjedna otvorenog liječenja tenofovirdizoproksilom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: Cmax, Cmin
Croatian: Srednja vrijednost postotka promjene AUC, Cmax, Cmin
English: Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to < 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg .
Croatian: 12 do < 18 godina) zaraženih HBV-om koji su primali peroralno dnevnu dozu tenofovirdizoproksila od 245 mg bila je slična izloženosti postignutoj u odraslih koji su primali dozu tenofovirdizoproksila od 245 mg jedanput na dan.
English: Parameter a
Croatian: (%)a
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/004 30 film-coated tablets EU/1/01/200/005 90 (3 bottles of 30) film-coated tablets
Croatian: EU/1/01/200/004 30 filmom obloženih tableta EU/1/01/200/005 90 (3 boce s 30) filmom obloženih tableta
English: Fifty-four patients (including 2 patients with lamivudine resistance mutations at baseline) initially received blinded placebo treatment for 72 weeks, and 52/54 patients followed with tenofovir disoproxil (PLB-TDF group).
Croatian: Pedeset četiri bolesnika (uključujući 2 bolesnika s mutacijama za rezistenciju na lamivudin na početku) početno je slijepo liječeno placebom 72 tjedna, nakon čega je
English: n 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Croatian: n 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega slijedi 240 jedana otvorenog ispitivanja tenofovirdizoproksila.
English: d 48 weeks double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil.
Croatian: d 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 192 tjedna otvorenog liječenja tenofovirdizoproksilom.
English: j 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Croatian: j 48 tjedana dvostruko slijepog tenofovirdizoproksila nakon čega je slijedilo 192 tjedna otvorenog liječenja.
English: Viread 245 mg film-coated tablets are light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.
Croatian: Viread 245 mg filmom obložene tablete su svijetloplave, filmom obložene tablete u obliku badema dimenzija 16,8 mm x 10,3 mm.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90d
Croatian: Adefovirdipivoksil 10 mg prebacivanje na tenofovirdizoproksil 245 mg n = 90d
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Croatian: Sofosbuvir (400 mg q.d.) + efavirenz/emtricitabin/tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Croatian: Nakon početka antivirusne terapije, u nekih bolesnika razina serumskog ALT-a može porasti (vidjeti dio 4.8).
English: baseline BMD Z-score a
Croatian: Serumske razine ALT i
English: Lumbar spine BMD at least 4% decrease b
Croatian: Smanjenje BMD-a lumbalne kralježnice za najmanje 6%b
English: What Viread contains
Croatian: Sadržaj pakiranja i druge informacije Što Viread sadrži
English: • fatty liver  If you think that your child may have any of these serious side effects, talk to your child's doctor.
Croatian: • Ako je Vaše dijete imalo bolest jetre, uključujući hepatitis, razgovarajte s liječnikom Vašeg djeteta.
English: Viread 163 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Croatian: Viread 163 mg tablete također se primjenjuju za liječenje kroničnog hepatitisa B, infekcije
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/001 30 film-coated tablets EU/1/01/200/002 90 (3 bottles of 30) film-coated tablets
Croatian: EU/1/01/200/001 30 filmom obloženih tableta EU/1/01/200/002 90 (3 boce po 30) filmom obloženih tableta
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Croatian: Adefovirdipivoksil 10 mg prebacivanje na tenofovirdizoproksil 245 mg n = 90
English: • Check your child's age and weight to see if Viread 163 mg tablets are suitable, see Children and adolescents.
Croatian: • Provjerite odgovaraju li Viread 163 mg tablete
English: EU/1/01/200/007
Croatian: EU/1/01/200/006 EU/1/01/200/007
English: k 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Croatian: k 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 192 tjedna otvorenog liječenja tenofovirdizoproksilom.
English: Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.)
Croatian: Antivirusni lijekovi za virus hepatitisa C Ledipasvir/sofosbuvir (90 mg/400 mg q.d.) + atazanavir/ritonavir (300 mg q.d./100 mg q.d.) + emtricitabin/tenofovirdizoproksil (200 mg/245 mg q.d.)1
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 204 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 204 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: (E421) and silicon dioxide (E551).
Croatian: 6.1 Popis pomoćnih tvari etilceluloza (E462) hidroksipropilceluloza (E463) manitol (E421) silicijev dioksid (E551)
English: Contact your child's doctor if your child is outside the permitted weight.
Croatian: Ako Vaše dijete ima tjelesnu težinu izvan dopuštene, obratite se liječniku Vašeg djeteta.
English: • Check your child's age and weight to see if Viread 123 mg tablets are suitable, see Children and adolescents.
Croatian: • Provjerite odgovaraju li Viread 123 mg tablete
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.)
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg q.d.) + darunavir/ritonavir (800 mg q.d./100 mg q.d.) + emtricitabin/tenofovirdizoproksil (200 mg/245 mg q.d.)
English: Thirteen percent (6/45) of the tenofovir disoproxil group, 13% (6/45) of the emtricitabine plus tenofovir disoproxil group, and
Croatian: 13% (6/45) u skupini liječenoj tenofovirdizoproksilom, 11% (5/45) u skupini liječenoj kombinacijom emtricitabina i tenofovirdizoproksila i 14% (3/22) u skupini liječenoj entekavirom.
English: Whole body mean (SD) change from baseline BMD Z-scorea
Croatian: Srednja vrijednost BMD Zrezultataa cijelog tijela Promjena srednje vrijednosti (SD) BMD Z-rezultataa cijelog tijela u odnosu na početak
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 163 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna filmom obložena tableta sadrži 123 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Croatian: Povećane koncentracije tenofovira u plazmi zbog istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira/voksilapr evira i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
English: If you are an adult, your doctor may advise you to reduce your daily dose of the granules.
Croatian: Vam može savjetovati da smanjite dnevnu dozu granula.
English: NA 5.14% 8.08% 10.05% 11.21%
Croatian: vidjeti dijelove 4.2, 4.4, 4.8 i 5.1..
English: EU/1/01/200/005
Croatian: EU/1/01/200/004 EU/1/01/200/005
English: Viread 204 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Croatian: Viread 204 mg tablete također se primjenjuju za liječenje kroničnog hepatitisa B, infekcije
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Croatian: Sofosbuvir/velpatasvir (400 mg/100 mg q.d.) + raltegravir (400 mg b.i.d) + emtricitabin/tenofovirdizoproksil (200 mg/245 mg q.d.)
English: At week 48, 77% (46 of 60) of patients in the tenofovir disoproxil treatment group and 7% (2 of 29) of patients in the placebo group had HBV DNA < 400 copies/mL (69 IU/mL).
Croatian: 48. tjednu, ukupno je 77% (46 od 60) bolesnika u skupini liječenoj tenofovirdizoproksilom i 7% (2 od
English: Entecavir
Croatian: Viread
English: + Efavirenz/Emtricitabine/ Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Croatian: Sofosbuvir (400 mg q.d.) + efavirenz/emtricitabin/tenofovirdiz oproksil (600 mg/200 mg/245 mg q.d.)
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day with food (for example, a meal or a snack).
Croatian: 22 kg: 1 tableta svaki dan s hranom (na primjer, s obrokom ili užinom).
English: • Don't stop any anti-HIV medicines prescribed by your doctor when you start Viread if you have both HBV and HIV.
Croatian: HIV-a koje vam je propisao vaš liječnik kad započnete terapiju Vireadom.
English: Tabulated summary of adverse reactions
Croatian: Tablični prikaz nuspojava
English: • Not for children and adolescents under 6 years or 12 years and over.
Croatian: • nisu za djecu mlađu od 6 godina i adolescente od 12 ili više godina Za doziranje pogledajte dio 3, Kako uzimati Viread.
English: Whole body mean (SD) change from baseline BMD Z-score a
Croatian: Srednja vrijednost BMD Z-rezultataa cijelog tijela Srednja vrijednost promjene (SD) BMD Z-rezultataa cijelog tijela u odnosu na početak
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Croatian: Ledipasvir/sofosbuvir (90 mg/400 mg q.d.) + emtricitabin/rilpivirin/tenofovirdizoproksil (200 mg/25 mg/245 mg q.d.)
English: Viread 123 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Croatian: Viread 123 mg tablete također se primjenjuju za liječenje kroničnog hepatitisa B, infekcije
English: The following side effects are uncommon (this can affect up to 1 in every 100 patients):
Croatian: • tegobe s jetrom Sljedeće nuspojave su manje česte (mogu se javiti u do 1 na svakih 100 bolesnika):
English: Lumbar spine mean (SD) change from baseline BMD Z-scorea
Croatian: Srednja vrijednost promjene (SD) BMD Z-rezultataa lumbalne kralježnice u odnosu na početak
English: Twenty-five percent (14 of 56) of patients in the tenofovir disoproxil group and 24% (7 of 29) of patients in the placebo group achieved HBeAg seroconversion at Week 48.Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatment-experienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/mL (69 IU/ml) at Week 48.
Croatian: Odgovor na liječenje tenofovirdizoproksilom bio je usporediv u prethodno neliječenih i prethodno liječenih ispitanika sa 76% (38/50) prethodno neliječnih i 80% (8/10) prethodno liječenih ispitanika koji su postigli HBV DNK < 400 kopija/ml (<69 IU/ml) u 48. tjednu.
English: Co-infection with HIV-1 and hepatitis B: Due to the risk of development of HIV resistance, tenofovir disoproxil should only be used as part of an appropriate antiretroviral combination regimen in
Croatian: Istovremena infekcija HIV-om tipa 1 i HBV-om: Zbog rizika od razvoja rezistencije HIV-a,
English: The first marketing authorisation (MA) was granted in France on 03 April 1987.
Croatian: Prvo odobrenje za stavljanje u promet (MA) odobreno je u Francuskoj 3. travnja 1987.
English: These changes were mostly technical in nature and therefore not discussed in detail here.
Croatian: Te su izmjene uglavnom tehničke prirode te ih stoga nećemo detaljno obraditi.
English: Section 1 - Name of the medicinal product and Section 2 - Qualitative and quantitative composition
Croatian: Odjeljak 1. - Naziv medicinskog proizvoda i Odjeljak 2. - Kvalitativni i kvantitativni sastav
English: • increased potential bleeding;
Croatian: • moguće veće krvarenje;
English: It is given as an injection subcutaneously or intravenously.
Croatian: Daje se injekcijom supkutano ili intravenozno.
English: Revisions were made to this section to add the risk of acute infectious endocarditis.
Croatian: Provedena je revizija ovog odjeljka kako bi se dodao rizik od akutnog infektivnog endokarditisa.
English: Direct Healthcare Provider Communication (DHPC)
Croatian: Izravno pismo zdravstvenim radnicima (DHPC)
English: This section was harmonised to reflect in a uniform way the following contraindications, of which not all were included across the EU, or different terminologies were used:
Croatian: Ovaj je odjeljak prilagođen kako bi na usklađen način izrazio sljedeće kontraindikacije jer nisu sve bile uključene u kontraindikacije diljem EU-a ili je korištena drugačija terminologija:
English: Sections 4.5 to 6 have been harmonised based on relevant available information or amended according to the latest QRD template.
Croatian: Odjeljci od 4.5. do 6. usklađeni su na temelju relevantnih dostupnih podataka ili su izmijenjeni na temelju posljednjeg ORD predloška.
English: Other sections such as “hyperkalaemia” were included as these were not uniformly worded across Member States.
Croatian: Drugi odjeljci kao što je "hiperkalemija" uključeni su jer nisu usklađeni u državama članicama.
English: Finally a wording was added to foster traceability of biological medicinal products.
Croatian: Na kraju je dodan tekst koji potiče sljedivost praćenja bioloških lijekova.
English: On one hand, an expression and dosing in mg is consistent with the approvals in the majority of the EU and allows both identification and distinction between different presentations whilst favouring ease of prescribing, dosing, dispensing and administration.
Croatian: S jedne strane, izražavanje i doziranje u miligramima u skladu je s odobrenjima u većini EU-a i omogućuje identifikaciju i razlikovanje različitih prezentacija čime se omogućuje jednostavnije propisivanje recepata, doziranje, davanje i primjenu.
English: The Product Information was split as follows according to the indications the individual products are approved for:
Croatian: Informacije o lijeku podijeljene su u skladu s indikacijama za koje su pojedinačni lijekovi odobreni:
English: Doses studied in the clinical studies vary from 0.5 mg/kg to 1.25 mg/kg.
Croatian: Doze ispitivane u kliničkim ispitivanjima kreću se od 0,5 mg/kg do 1,25 mg/kg.
English: • the product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Croatian: • informacije o lijeku koje su predložili nositelji odobrenja za stavljanje proizvoda u promet ocijenjene su na temelju dostavljene dokumentacije i znanstvene rasprave unutar Odbora;
English: The harmonised indication is based on treatment guidelines (European Society of Cardiology (ESC), and ACCP), as well as clinical study and literature data presented by the MAH.
Croatian: Usklađena indikacija temelji se na smjernicama za liječenje (Europsko kardiološko društvo (ESC) i ACCP), kao i kliničkom ispitivanju i podacima iz literature koje je predstavio MAH.
English: Furthermore, the indications were not the same depending on the strength of the product, which was addressed as part of the referral.
Croatian: Štoviše, indikacije nisu bile iste ovisno o jačini proizvoda, a to je obrađeno u postupku upućivanja.
English: Lovenox and associated names solution for injection is currently approved in more than 140 countries worldwide including all the European Union (EU) member states as well as Norway and Iceland.
Croatian: Lovenox i otopine povezanih naziva za injektiranje trenutačno su odobreni u više od 140 država diljem svijeta, uključujući sve države članice Europske unije (EU), kao i Island i Norvešku.
English: This anticoagulant is used in the treatment and prophylaxis of thromboembolic disorders.
Croatian: Taj antikoagulans koristi se u liječenju i profilaksi tromboembolijskih poremećaja.
English: Lovenox and associated names is authorised in all EU member states (MSs) as well as in Iceland and Norway.
Croatian: Lovenox i povezani nazivi odobreni su u svim državama članicama EU-a, kao i u Islandu i Norveškoj.
English: Section 4.1 - Therapeutic Indications
Croatian: Odjeljak 4.1. - Terapijske indikacije
English: The CHMP adopted a wording, which is in agreement with the clinical data and treatment guidelines (grade IIbB in ESC guidelines 2012, American Heart Association (AHA) guideline 2011).
Croatian: CHMP usvojio je tekst koji je u skladu s kliničkim podacima i smjernicama za liječenje (razred IIbB u smjernicama ESC-a iz 2012., smjernicama Američke udruge za srce (AHA) iz 2011.).