FrancophonIA/ELRC3.0 huggingface dataset:
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide
Croatian: • Ovojnica kapsule sadrži: želatinu, titanijev dioksid (E171), indigotin (E132), žuti željezov oksid
English: The prescriber must ensure that for women of childbearing potential:
Croatian: Kod žena reproduktivne dobi liječnik pri propisivanju ovoga lijeka mora provjeriti:
English: Respiratory tract infection Upper respiratory tract infection Nasopharyngitis Herpes zoster
Croatian: Često neutropenijska sepsa bronhopneumonija bronhitis infekcija dišnih puteva infekcija gornjih dišnih puteva nazofaringitis herpes zoster
English: Common Cardiac failure Atrial fibrillation
Croatian: Često srčano zatajenje fibrilacija atrija
English: Depressed level of consciousness Peripheral sensory neuropathy Dizziness
Croatian: Često snižena razina svijesti periferna senzorna neuropatija omaglica tremor
English: Imnovid 4 mg hard capsules: Dark blue opaque cap and blue opaque body, with “POML 4 mg” written on them.
Croatian: Imnovid 4 mg tvrde kapsule: tamnoplava neprozirna kapica i plavo neprozirno tijelo, s oznakom „POML 4 mg“.
English: Common Hyperkalaemia Hyponatraemia
Croatian: Često hiperkalijemija hiponatrijemija
English: Common Cataract
Croatian: Često katarakta
English: Uncommon Pulmonary embolism Cough
Croatian: Manje često plućna embolija kašalj
English: Uncommon Dizziness Tremor
Croatian: Manje često omaglica tremor
English: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule.
Croatian: Tamnoplava neprozirna kapica i žuto neprozirno tijelo, s otisnutim „POML“ bijelom tintom i „1 mg“ crnom tintom, veličine 4, tvrda želatinska kapsula.
English: ILD and related events, including cases of pneumonitis, have been observed with pomalidomide.
Croatian: Kod primjene pomalidomida opažena je intersticijska bolest pluća (IBP) i uz nju povezani događaji, uključujući slučajeve pneumonitisa.
English: Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2.
Croatian: PFS u ITT populaciji i pripadajuća Kaplan-Meierova krivulja preživljenja prikazani su u tablici 11, odnosno na slici 2.
English: Permanently discontinue treatment (see section
Croatian: Trajno prekinuti liječenje (vidjeti dio 4.4).
English: Pom+Btz+LD-Dex (N = 281)
Croatian: Sažetak ukupnih podataka djelotvornosti Pom+Btz+LD-Dex (N = 281)
English: Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written on them.
Croatian: Imnovid 3 mg tvrde kapsule: tamnoplava neprozirna kapica i zeleno neprozirno tijelo, s oznakom „POML 3 mg“.
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) Erythrosin (E127) White ink
Croatian: Imnovid 2 mg tvrde kapsule želatina titanijev dioksid (E171) indigotin (E132) žuti željezov oksid (E172) eritrozin (E127) bijela tinta
English: For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
Croatian: Za informacije o bortezomibu u kombinaciji s Imnovidom, vidjeti važeći sažetak opisa svojstava lijeka.
English: Mean normalised AUC exposure to pomalidomide was 98.2% with a 90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to ≤45 mL/minute/1.73 m2) compared to patients with normal renal function.
Croatian: U bolesnika s umjerenim oštećenjem funkcije bubrega (eGFR ≥30 do ≤45 ml/min/1,73 m2) u usporedbi s bolesnicima u kojih je funkcija bubrega bila normalna, srednja vrijednost izloženosti pomalidomidu (AUC) normalizirana na dozu iznosila je 98,2% uz interval pouzdanosti od 90% [od 77,4% do 120,6%].
English: Hepatic disorders
Croatian: Krvožilni poremećaji
English: • That the patient should not donate blood during therapy (including during dose interruptions) and for
Croatian: • da bolesnik ne smije darivati krv tijekom liječenja pomalidomidom (uključujući privremene prekide liječenja) i još 7 dana nakon prestanka liječenja
English: However, dose interruption / resumption decisions are at physician's discretion per the current Summary of Product Characteristics (SmPC).
Croatian: Međutim, odluke o prekidu primjene doze / nastavku liječenja donosi liječnik prema važećem sažetku opisa svojstava lijeka.
English: Tabulated list of post-marketing adverse reactions
Croatian: Tablični popis nuspojava zabilježenih nakon stavljanja lijeka u promet
English: Very Common Neutropenia Thrombocytopenia Anaemia
Croatian: Vrlo često neutropenija trombocitopenija anemija
English: No dose adjustment of pomalidomide is required for patients with renal impairment.
Croatian: Nije potrebna prilagodba doze pomalidomida.
English: Uncommon Hyperbilirubinaemia
Croatian: Manje često hiperbilirubinemija
English: However, dose interruption or resumption decisions are at the physician's discretion per Summary of Product Characteristics (SmPC).
Croatian: Međutim, odluke o prekidu primjene ili nastavku liječenja donosi liječnik prema sažetku opisa svojstava lijeka.
English: Clostridium difficile colitis Respiratory tract infection Lower respiratory tract infection Lung infection
Croatian: Često sepsa septički šok kolitis uzrokovan Clostridium difficile infekcija dišnih puteva infekcija donjih dišnih puteva infekcija pluća influenca bronhiolitis infekcija mokraćnog sustava
English: No adjustment of the starting dose of pomalidomide is required for patients with hepatic impairment as defined by the Child-Pugh criteria.
Croatian: U bolesnika s oštećenjem funkcije jetre definiranim na temelju Child-Pugh kriterija, prilagodba početne doze pomalidomida nije potrebna.
English: Imnovid 1 mg hard capsule:
Croatian: Imnovid 1 mg tvrde kapsule:
English: Uncommon Tumour lysis syndrome
Croatian: Manje često sindrom lize tumora
English: Common Pulmonary embolism
Croatian: Često plućna embolija
English: Very Common Diarrhoea Vomiting Nausea
Croatian: Vrlo često proljev povraćanje mučnina konstipacija
English: Imnovid 1 mg hard capsules pomalidomide
Croatian: Imnovid 1 mg tvrde kapsule pomalidomid
English: Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written on them.
Croatian: Imnovid 2 mg tvrde kapsule: tamnoplava neprozirna kapica i narančasto neprozirno tijelo, s oznakom „POML 2 mg“.
English: Uncommon Angioedema Urticaria
Croatian: Često osip pruritus
English: The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Croatian: Sve nuspojave i nuspojave 3. ili 4. stupnja opažene u bolesnika liječenih pomalidomidom u kombinaciji s bortezomibom i deksametazonom navedene su u tablici 7 prema klasifikaciji organskih sustava i učestalosti.
English: Common Renal failure Urinary retention
Croatian: Često zatajenje bubrega urinarna retencija
English: Very Common Neutropenia Thrombocytopenia Leucopenia Anaemia
Croatian: Vrlo često neutropenija trombocitopenija leukopenija anemija
English: Very Common
Croatian: Često dispneja
English: Mean normalised AUC exposure to pomalidomide was 100.2% with a 90% confidence interval [79.7% to 127.0%] in severe renal impairment patients not requiring dialysis (CrCl <30 or eGFR <30 mL/minute/1.73 m2) compared to patients with normal renal function.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega kojima nije bila potrebna dijaliza (CrCl <30 ili eGFR <30 ml/min/1,73 m2) u usporedbi s bolesnicima u kojih je funkcija bubrega bila normalna, srednja vrijednost izloženosti pomalidomidu (AUC) normalizirana na dozu bila je 100,2% uz interval pouzdanosti od 90% [od 79,7% do 127,0%].
English: Medicine name Day IMN DEX
Croatian: • IMN: Imnovid; DEKS: Deksametazon Naziv lijeka Dan IMN DEKS
English: Imnovid 2 mg hard capsule:
Croatian: Imnovid 2 mg tvrde kapsule:
English: Common Febrile neutropenia Leucopenia
Croatian: Često febrilna neutropenija leukopenija
English: • Each capsule contains 4 mg of pomalidomide.
Croatian: • Jedna kapsula sadrži 4 mg pomalidomida.
English: Mean normalised AUC exposure to pomalidomide increased by 35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis (CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function.
Croatian: U bolesnika s teškim oštećenjem funkcije bubrega kojima je bila potrebna dijaliza (CrCl <30 ml/min, potrebna je dijaliza) u usporedbi s bolesnicima u kojih je funkcija bubrega bila normalna, srednja vrijednost izloženosti pomalidomidu (AUC) normalizirana na dozu povećala se za 35,8% uz 90% CI [od 7,5% do 70,0%].
English: Non-cardiac chest pain Oedema peripheral Oedema
Croatian: Često umor pireksija nekardijalni bol u prsnom košu periferni edem edem
English: Very Common Peripheral sensory neuropathy Dizziness
Croatian: Vrlo često periferna senzorna neuropatija omaglica tremor
English: • Each capsule contains 3 mg of pomalidomide.
Croatian: • Jedna kapsula sadrži 3 mg pomalidomida.
English: • Abdominal pain, swollen abdomen.
Croatian: Manje često bol u gornjem abdomenu stomatitis mučnina distenzija abdomena
English: Common Febrile neutropenia Leucopenia Lymphopenia
Croatian: Često febrilna neutropenija leukopenija limfopenija
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Celgene Distribution B.V.
English: Each hard capsule contains 4 mg of pomalidomide.
Croatian: Jedna tvrda kapsula sadrži 4 mg pomalidomida.
English: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule.
Croatian: Tamnoplava neprozirna kapica i plavo neprozirno tijelo, s otisnutim „POML 4 mg“ bijelom tintom, veličine 2, tvrda želatinska kapsula.
English: Imnovid 1 mg hard capsules
Croatian: Imnovid 1 mg tvrda kapsula
English: Each hard capsule contains 3 mg of pomalidomide.
Croatian: Jedna tvrda kapsula sadrži 3 mg pomalidomida.
English: Each hard capsule contains 1 mg of pomalidomide.
Croatian: Jedna tvrda kapsula sadrži 1 mg pomalidomida.
English: ADRs reported in post-marketing use in patients treated with pomalidomide.
Croatian: Tablica 9. Nuspojave zabilježene u bolesnika liječenih pomalidomidom nakon stavljanja lijeka u promet
English: Imnovid 4 mg hard capsule:
Croatian: Imnovid 4 mg tvrde kapsule:
English: Common Febrile neutropenia Lymphopenia
Croatian: Često febrilna neutropenija limfopenija
English: Low-dose dexamethasone (20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old]) was administered to patients in both study arms on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle for Cycles 1 to 8; and on Days 1, 2, 8 and 9 of each subsequent 21-day cycle from Cycles 9 onwards.
Croatian: >75 godina]) primjenjivana je objema skupinama bolesnika 1., 2., 4., 5., 8., 9., 11. i 12. dana 21-dnevnog ciklusa od 1. do 8. ciklusa te 1., 2., 8. i 9. dana svakog 21-dnevnog ciklusa od 9. ciklusa nadalje.
English: • Each capsule contains 1 mg of pomalidomide.
Croatian: • Jedna kapsula sadrži 1 mg pomalidomida.
English: What Imnovid looks like and contents of the pack Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written on them.
Croatian: Imnovid 1 mg tvrde kapsule: tamoplava, neprozirna kapica i žuto neprozirno tijelo, s oznakom „POML 1 mg“.
English: Imnovid 2 mg hard capsules pomalidomide
Croatian: Imnovid 2 mg tvrde kapsule pomalidomid
English: Progression Free Survival Time by IRAC Review Based on IMWG Criteria (Stratified Log Rank Test) (ITT Population)
Croatian: Tablica 11: Razdoblje preživljenja bez progresije bolesti prema sustavnom pregledu IRAC-a na temelju kriterija IMWG-a (stratificirani log-rang test) (analiza ITT populacije)
English: 6.6 Special precautions for disposal and other handling Capsules should not be opened or crushed.
Croatian: Kapsule se ne smiju otvarati ni drobiti.
English: Each hard capsule contains 2 mg of pomalidomide.
Croatian: Jedna tvrda kapsula sadrži 2 mg pomalidomida.
English: • Each capsule contains 2 mg of pomalidomide.
Croatian: • Jedna kapsula sadrži 2 mg pomalidomida.
English: Imnovid 3 mg hard capsule:
Croatian: Imnovid 3 mg tvrde kapsule:
English: Imnovid 4 mg hard capsules pomalidomide
Croatian: Imnovid 4 mg tvrde kapsule pomalidomid
English: Instructions for dose modification for dexamethasone related adverse reactions are outlined in Table 4.
Croatian: Prilagodba doze ili prekid primjene deksametazona Upute za prilagodbu doze zbog nuspojava povezanih s deksametazonom navedene su u tablici 4. Upute za smanjenje doze zbog nuspojava povezanih s deksametazonom navedene su u tablici 6 u nastavku.
English: Decrease by one dose level if symptoms persist.
Croatian: Ako simptomi potraju, smanjiti dozu za jednu razinu.
English: For oral use
Croatian: Za primjenu kroz usta
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ink
Croatian: Imnovid 3 mg tvrde kapsule želatina titanijev dioksid (E171) indigotin (E132) žuti željezov oksid (E172) bijela tinta
English: Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard capsule.
Croatian: Tamnoplava neprozirna kapica i zeleno neprozirno tijelo, s otisnutim „POML 3 mg“ bijelom tintom, veličine 2, tvrda želatinska kapsula.
English: Bortezomib (1.3 mg/m
Croatian: Bolesnici obiju skupina primali su bortezomib (1,3 mg/m2 po dozi) 1., 4.,
English: Imnovid 3 mg hard capsules pomalidomide
Croatian: Imnovid 3 mg tvrde kapsule pomalidomid
English: Very Common Bone pain Muscle spasms
Croatian: Vrlo često bol u kostima grčevi u mišićima
English: Bronchopneumonia Respiratory tract infection Upper respiratory tract infection
Croatian: Infekcije i infestacije Vrlo često pneumonija bronhitis infekcija gornjih dišnih puteva virusna infekcija gornjih dišnih puteva
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White and black ink
Croatian: Imnovid 1 mg tvrde kapsule želatina titanijev dioksid (E171) indigotin (E132) žuti željezov oksid (E172) bijela i crna tinta
English: Imnovid 2 mg hard capsules
Croatian: Imnovid 2 mg tvrde kapsule
English: Abdominal pain Abdominal pain upper Stomatitis
Croatian: Često bol u abdomenu bol u gornjem abdomenu stomatitis suha usta distenzija abdomena
English: Very Common Diarrhoea Nausea
Croatian: Vrlo često proljev mučnina konstipacija
English: muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes.
Croatian: • niske razine kalija u krvi (hipokalijemija) što može prouzročiti slabost, grčeve u mišićima, bolove u mišićima, osjećaj lupanja srca, trnce ili utrnulost, otežano disanje, promjene raspoloženja
English: • The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527).
Croatian: • Tinta za označavanje sadrži: bijelu tintu - šelak, titanijev dioksid (E171), simetikon,
English: • Damage to the kidney.
Croatian: • oštećenje bubrega
English: Bronchiolitis
Croatian: Trombocitopenija
English: Imnovid 4 mg hard capsules
Croatian: Imnovid 4 mg tvrda kapsula
English: Peripheral sensory neuropathy Peripheral sensorimotor neuropathy
Croatian: Često sinkopa periferna senzorna neuropatija periferna senzomotorna neuropatija
English: Imnovid 3 mg hard capsules
Croatian: Imnovid 3 mg tvrde kapsule
English: Common Diarrhoea Vomiting Constipation
Croatian: Često proljev povraćanje konstipacija
English: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule.
Croatian: Tamnoplava neprozirna kapica i narančasto neprozirno tijelo, s otisnutim „POML 2 mg“ bijelom tintom, veličine 2, tvrda želatinska kapsula.
English: Hepatobiliary disorders Uncommon Hepatitis
Croatian: Infekcije i infestacije Nepoznato reaktivacija hepatitisa B
English: • Pomalidomide in combination with bortezomib and dexamethasone No dose adjustment is required for pomalidomide.
Croatian: • Pomalidomid u kombinaciji s bortezomibom i deksametazonom
English: Population Pharmacokinetics (PK)
Croatian: Populacijska farmakokinetika
English: Posology
Croatian: medijana
English: EU/1/13/850/008 (Pack size of 14 hard capsules) EU/1/13/850/004 (Pack size of 21 hard capsules)
Croatian: EU/1/13/850/008 (pakiranje od 14 tvrdih kapsula) EU/1/13/850/004 (pakiranje od 21 tvrde kapsule)
English: EU/1/13/850/007 (Pack size of 14 hard capsules) EU/1/13/850/003 (Pack size of 21 hard capsules)
Croatian: EU/1/13/850/007 (pakiranje od 14 tvrdih kapsula) EU/1/13/850/003 (pakiranje od 21 tvrde kapsule)
English: Angioedema and severe dermatologic reactions including SJS, TEN and DRESS have been reported with the use of pomalidomide (see section 4.8).
Croatian: Uz primjenu pomalidomida zabilježeni su angioedem i teške dermatološke reakcije, uključujući Stevens-Johnsonov sindrom, toksičnu epidermalnu nekrolizu i reakciju na lijek s eozinofilijom i sistemskim simptomima (vidjeti dio 4.8).
English: EU/1/13/850/006 (Pack size of 14 hard capsules) EU/1/13/850/002 (Pack size of 21 hard capsules)
Croatian: EU/1/13/850/006 (pakiranje od 14 tvrdih kapsula) EU/1/13/850/002 (pakiranje od 21 tvrde kapsule)
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection
Croatian: Često sepsa septički šok kolitis uzrokovan Clostridium difficile bronhitis infekcija gornjih dišnih puteva infekcija dišnih puteva infekcija donjih dišnih puteva infekcija pluća influenca bronhiolitis infekcija mokraćnog sustava
English: Common Angioedema Urticaria
Croatian: Često angioedem urtikarija
English: • Inability to pass urine.
Croatian: • nemogućnost mokrenja
English: Peripheral sensory neuropathy Dizziness
Croatian: Manje često periferna senzorna neuropatija omaglica tremor
English: EU/1/13/850/005 (Pack size of 14 hard capsules) EU/1/13/850/001 (Pack size of 21 hard capsules)
Croatian: EU/1/13/850/005 (pakiranje od 14 tvrdih kapsula) EU/1/13/850/001 (pakiranje od 21 tvrde kapsule)
English: Very Common Insomnia
Croatian: Psihijatrijski poremećaji Vrlo često nesanica
English: Hepatic impairment
Croatian: Često vrtoglavica
English: Common Deep vein thrombosis
Croatian: Često duboka venska tromboza
English: All Adverse Reactions /Frequency
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Dexamethasone (20 mg) * • • * For patients > 75 years of age, see Special populations.
Croatian: >75 godina vidjeti Posebne populacije.
English: Gastrointestinal haemorrhage
Croatian: Često povraćanje gastrointestinalno krvarenje
English: The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions.
Croatian: Sve nuspojave i nuspojave 3. ili 4. stupnja primijećene kod bolesnika liječenih pomalidomidom s deksametazonom navedene su u nastavku u tablici 8 prema klasifikaciji organskih sustava i učestalosti.
English: Common Fall
Croatian: Često pad
English: • Being sick (vomiting).
Croatian: mučnina ili povraćanje)
English: • Pain in the pelvis.
Croatian: • bol u zdjelici
English: 90 (3 x 30) tablets (multipack)
Croatian: Veličina pakiranja bočica (HDPE) 30 tableta bočica (HDPE) 90 (3 x 30) tableta (multipakiranje)
English: The full EPAR for Dafiro HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Dafiro HCT može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Croatian: Dostupan je kao tablete koje sadrže amlodipin, valsartan i hidroklorotiazid u sljedećim količinama: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg i 10/320/25 mg.
English: Dafiro HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Croatian: Dafiro HCT se uzima peroralno kao jedna tableta jednom na dan s malo vode, uvijek u isto vrijeme i to najbolje ujutro.
English: The three active substances in Dafiro HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Croatian: Tri djelatne tvari u lijeku Dafiro HCT su antihipertenzivi koji se već primjenjuju u Europskoj uniji (EU).
English: Patients received either Dafiro HCT or one of the three combinations containing only two of the active substances for eight weeks.
Croatian: Bolesnici su primili Dafiro HCT ili jednu od tri kombinacije koje su sadržavale samo dvije djelatne tvari tijekom razdoblja od osam tjedana.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dafiro HCT on 4 November 2009.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za lijek Dafiro HCT vrijedi na prostoru Europske unije od 4. studenog 2009.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dafiro HCT.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje za izdavanje odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za uporabu za lijek Dafiro HCT.
English: For more information about treatment with Dafiro HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Dafiro HCT pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Treatment with the highest strength of Dafiro HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
Croatian: Liječenje najjačom dozom lijeka Dafiro HCT bilo je učinkovitije u liječenju hipertenzije od dualnih kombinacija koje su sadržavale bilo koje dvije djelatne tvari.
English: This is a summary of the European public assessment report (EPAR) for Dafiro HCT.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Dafiro HCT.
English: The main study showed the benefit of the highest strength of Dafiro HCT in lowering the blood pressure.
Croatian: Glavnim je ispitivanjem dokazana korist najjače doze lijeka Dafiro HCT u snižavanju krvnoga tlaka.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Dafiro HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Croatian: Prosječno snižavanje krvnoga tlaka bilo je otprilike 39,7/24,7 mmHg u bolesnika koji su primali Dafiro HCT u usporedbi s 32/19,7 mmHg, 33,5/21,5 mmHg i 31,5/19,5 mmHg u bolesnika koji su primali kombinacije valsartana/ hidroklorotiazida, valsartana/amlodipina, odnosno hidroklorotiazida/amlodipina.
English: The dose of Dafiro HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Croatian: Doza lijeka Dafiro HCT koja će se primijeniti jednaka je dozama tri individualne djelatne tvari koje je bolesnik ranije uzimao.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Croatian: Nadalje, provedeno je jedno glavno ispitivanje na 2.271 bolesniku s umjerenom do ozbiljnom hipertenzijom s najjačom dozom lijeka Dafiro HCT (320 mg valsartana, 10 mg amlodipina i 25 mg hidroklorotiazida).