natgillin/translations-raw huggingface dataset:
The tablets are supplied in PVC/PVDC/Aluminium blister packs of 14, 20, 28, 56, 168 or 196 tablets and in multipacks of 196 tablets (7 packs of 28 tablets). 
Tablete se isporučuju u PVC/PVDC/aluminij blister pakiranjima od 14, 20, 28, 56, 168 ili 196 tableta i u višestrukom pakiranju od 196 tableta (7 pakiranja od po 28 tableta).
No dose adjustment is required when administering Entresto to patients with mild hepatic impairment (Child-Pugh A classification). 
Nije potrebno prilagođavanje doze kada se Entresto primjenjuje u bolesnika s blagim oštećenjem jetre (stupanj A prema Child-Pugh klasifikaciji).
Combination of Entresto with aliskiren is potentially associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) (see sections 4.3 and 4.4). 
Kombinacija Entresta s aliskirenom je potencijalno povezana s višom učestalošću nuspojava kao što su hipotenzija, hiperkalijemija i smanjena funkcija bubrega (uključujući akutno zatajenje bubrega) (vidjeti dijelove 4.3 i 4.4).
The pharmacokinetics of sacubitril, LBQ657 and valsartan were approximately linear over an Entresto dose range of 24 mg sacubitril/26 mg valsartan to 97 mg sacubitril/103 mg valsartan. 
Farmakokinetika sakubitrila, LBQ657 i valsartana bila je otprilike linearna u rasponu doza Entresta od 24 mg sakubitrila/26 mg valsartana do 97 mg sakubitrila/103 mg valsartana.
Pump failure accounted for 26% of cardiovascular deaths and was reduced by 21% in Entresto-treated patients compared to enalapril-treated patients (HR 0.79, p=0.0338). 
Zatajenje srca kao pumpe predstavljalo je 26% kardiovaskularnih smrti i bilo je smanjeno za 21% u bolesnika liječenih Entrestom u usporedbi s bolesnicima liječenima enalaprilom (HR 0,79, p=0,0338).
In PARADIGM-HF, angioedema was reported in 0.5% of patients treated with Entresto, compared with 0.2% of patients treated with enalapril. 
U ispitivanju PARADIGM-HF, angioedem je bio zabilježen u 0,5% bolesnika liječenih Entrestom, u usporedbi s 0,2% bolesnika liječenih enalaprilom.
BNP is not a suitable biomarker of heart failure in patients treated with Entresto because BNP is a neprilysin substrate (see section 4.4). 
BNP nije prikladan biomarker zatajenja srca u bolesnika liječenih Entrestom zato što je BNP supstrat neprilizina (vidjeti dio 4.4).
***One-sided p-value ♯ Full analysis set 
***Jednostrana p-vrijednost
Entresto exhibits the mechanism of action of an angiotensin receptor neprilysin inhibitor by simultaneously inhibiting neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and by blocking the angiotensin II type-1 (AT1) receptor via valsartan. 
Entresto pokazuje mehanizam djelovanja inhibitora angiotenzinskog receptora i neprilizina tako što istodobno inhibira neprilizin (neutralna endopeptidaza; NEP) putem LBQ657, aktivnog metabolita prolijeka sakubitrila, te blokira receptor angiotenzina II tip 1 (AT1) putem valsartana.
Co-administration of Entresto increased the Cmax of atorvastatin and its metabolites by up to 2-fold and AUC by up to 1.3-fold. 
Istodobna primjena Entresta povećala je Cmax atorvastatina i njegovih metabolita za do 2 puta te AUC za do 1,3 puta.
More patients who were naïve to previous ACE inhibitor or ARB therapy or on low-dose therapy (equivalent to <10 mg enalapril/day) were able to achieve and maintain Entresto 200 mg when up-titrated over 6 weeks (84.8%) versus 3 weeks (73.6%). 
Više je bolesnika koji nikada prije nisu primali terapiju ACE inhibitorom ili ARB-om ili koji su bili na terapiji niskom dozom (ekvivalentno <10 mg enalaprila/dan) moglo postići i održati dozu Entresta od 200 mg kada se doza titrirala prema većoj tijekom 6 tjedana (84,8%) u odnosu na 3 tjedna (73,6%).
In a thorough QTc clinical study in healthy male subjects, single doses of Entresto 194 mg sacubitril/206 mg valsartan and 583 mg sacubitril/617 mg valsartan had no effect on cardiac repolarisation. 
U temeljitom kliničkom ispitivanju QTc intervala u zdravih muških ispitanika, jednokratne doze Entresta od 194 mg sakubitrila/206 mg valsartana te 583 mg sakubitrila/617 mg valsartana nisu imale učinak na srčanu repolarizaciju.
Patients were required to discontinue their existing ACE inhibitor or ARB therapy and enter a sequential single-blind run-in period during which they received treatment with enalapril 10 mg twice daily, followed by single-blind treatment with Entresto 100 mg twice daily, increasing to 200 mg twice daily (see section 4.8 for discontinuations during this period). 
Bolesnici su trebali prekinuti postojeću terapiju ACE inhibitorom ili ARB-om te ući u uzastopno jednostruko slijepo ulazno razdoblje tijekom kojeg su primali terapiju enalaprilom 10 mg dvaput na dan, nakon čega je slijedilo jednostruko slijepo liječenje Entrestom 100 mg dvaput na dan, povećano na 200 mg dvaput na dan (vidjeti dio 4.8 za prekide tijekom tog razdoblja).
The most commonly reported adverse reactions during treatment with Entresto were hypotension, hyperkalaemia and renal impairment (see section 4.4). 
Najčešće prijavljene nuspojave tijekom liječenja Entrestom bile su hipotenzija, hiperkalijemija i oštećenje bubrega (vidjeti dio 4.4).
In PARADIGM-HF, hyperkalaemia and serum potassium concentrations >5.4 mmol/l were reported in 11.6% and 19.7% of Entresto-treated patients and 14.0% and 21.1% of enalapril-treated patients, respectively. 
U ispitivanju PARADIGM-HF, hiperkalijemija i koncentracije kalija u serumu >5.4 mmol/l bile su prijavljene u 11,6% i 19,7% bolesnika liječenih Entrestom, odnosno u 14,0% i 21,1% bolesnika liječenih enalaprilom.
The complementary cardiovascular benefits of Entresto in heart failure patients are attributed to the enhancement of peptides that are degraded by neprilysin, such as natriuretic peptides (NP), by LBQ657 and the simultaneous inhibition of the effects of angiotensin II by valsartan. 
Komplementarne kardiovaskularne koristi Entresta u bolesnika sa zatajenjem srca pripisuju se povećanju količine peptida koje neprilizin razgrađuje, kao što su natriuretski peptidi (NP), pomoću LBQ657 i istodobnoj inhibiciji učinaka angiotenzina II od strane valsartana.
Animal studies with Entresto have shown reproductive toxicity (see section 5.3). 
Ispitivanja Entresta u životinja su pokazala reproduktivnu toksičnost (vidjeti dio 5.3).
It is teratogenic based on a low incidence of foetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an Entresto dose of ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day. 
On je teratogen na temelju niske incidencije fetalne hidrocefalije, povezano s toksičnim dozama za majku, što je bilo uočeno u zečeva uz dozu Entresta ≥4,9 mg sakubitrila/5,1 mg valsartana/kg/dan.
In PARADIGM-HF, hypotension and clinically relevant low systolic blood pressure (<90 mmHg and decrease from baseline of >20 mmHg) were reported in 17.6% and 4.76% of Entresto-treated patients compared with 11.9% and 2.67% of enalapril-treated patients, respectively. 
U ispitivanju PARADIGM-HF, hipotenzija i klinički značajan niski sistolički krvni tlak (<90 mmHg i smanjenje od početne vrijednosti >20 mmHg) bili su prijavljeni u 17,6% i 4,76% bolesnika liječenih Entrestom, odnosno u 11,9% i 2,67% bolesnika liječenih enalaprilom.
The combination of Entresto with direct renin inhibitors such as aliskiren is not recommended (see section 4.4). 
Kombinacija Entresta s izravnim inhibitorima renina kao što je aliskiren nije preporučena (vidjeti dio 4.4).
Entresto is contraindicated in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy or with hereditary or idiopathic angioedema (see section 4.3). 
Entresto je kontraindiciran u bolesnika s angioedemom u anamnezi povezanim s prethodnom terapijom ACE inhibitorom ili ARB-om ili s nasljednim ili idiopatskim angioedemom (vidjeti dio 4.3).
ACE inhibitor therapy must not be started until 36 hours after the last dose of Entresto (see sections 4.2 and 4.3). 
Terapija ACE inhibitorom ne smije se započinjati do 36 sati nakon zadnje doze Entresta (vidjeti dijelove 4.2 i 4.3).
Monitoring of serum potassium is recommended if Entresto is co-administered with these agents (see section 4.4). 
Preporučuje se praćenje kalija u serumu ako se Entresto primjenjuje istodobno s tim tvarima (vidjeti dio 4.4).
Following twice daily dosing of Entresto, steady-state levels of sacubitril, LBQ657 and valsartan are reached in three days. 
Nakon doziranja Entresta dvaput na dan, razine sakubitrila, LBQ657 i valsartana u stanju dinamičke ravnoteže postižu se za tri dana.
If treatment with Entresto is stopped, ACE inhibitor therapy must not be initiated until 36 hours after the last dose of Entresto (see sections 4.2, 4.3 and 4.5). 
Ako se prekine liječenje Entrestom, terapija ACE inhibitorom ne smije se započinjati do 36 sati nakon zadnje doze Entresta (vidjeti dijelove 4.2, 4.3 i 4.5).
BNP is not a suitable biomarker of heart failure in patients treated with Entresto because it is a neprilysin substrate (see section 5.1). 
BNP nije odgovarajući biomarker zatajenja srca u bolesnika liječenih Entrestom zato što je supstrat neprilizina (vidjeti dio 5.1).
If any of the above applies to you, tell your doctor or pharmacist before you take Entresto. 
Ako se bilo što od navedenoga odnosi na Vas, obratite se svom liječniku ili ljekarniku prije uzimanja Entresta.
• The combination of Entresto with direct renin inhibitors such as aliskiren is not recommended (see section 4.5). 
• Kombinacija Entresta s direktnim inhibitorima renina kao što je aliskiren nije preporučljiva (vidjeti dio 4.5).
Angioedema has been reported in patients treated with Entresto. 
Angioedem je prijavljen u bolesnika liječenih Entrestom.
Entresto is contraindicated in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (Child-Pugh C classification) (see section 4.3). 
Entresto je kontraindiciran u bolesnika s teškim oštećenjem jetre, bilijarnom cirozom ili kolestazom (Child-Pugh stupanj C) (vidjeti dio 4.3).
If hypotension occurs, temporary down-titration or discontinuation of Entresto is recommended (see section 4.2). 
preporučuje se privremeno postupno sniženje doze ili prekid primjene Entresta (vidjeti dio 4.2).
No clinically relevant drug-drug interaction was observed when simvastatin and Entresto were coadministered. 
Nije primjećena klinički značajna interakcija među lijekovima prilikom istodobne primjene simvastatina i Entresta.
In a 21-day study in HFrEF patients, Entresto significantly increased urine ANP and cGMP and plasma cGMP, and decreased plasma NT-proBNP, aldosterone and endothelin-1 compared to baseline. 
U 21-dnevnom ispitivanju u bolesnika s HFrEF-om, Entresto je značajno povećao ANP i cGMP u mokraći te cGMP u plazmi, a smanjio NT-proBNP, aldosteron i endotelin-1 u plazmi u usporedbi s početnim vrijednostima.
If any of the above applies to you, tell your doctor, pharmacist or nurse before you take Entresto. 
Ako se bilo što od navedenoga odnosi na Vas, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije uzimanja Entresta.
Entresto has not been studied in patients with severe hepatic impairment, biliary cirrhosis or cholestasis (see sections 4.3 and 4.4). 
Entresto nije bio ispitivan u bolesnika s teškim oštećenjem jetre, bilijarnom cirozom ili kolestazom (vidjeti dijelove 4.3 i 4.4).
In the PARADIGM-HF study, Entresto decreased plasma NT-proBNP and increased plasma BNP and urine cGMP compared with enalapril. 
U ispitivanju PARADIGM-HF, Entresto je smanjio NT-proBNP u plazmi i povećao BNP u plazmi i cGMP u mokraći u usporedbi s enalaprilom.
14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 168 film-coated tablets 196 film-coated tablets 
14 filmom obloženih tableta 20 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 168 filmom obloženih tableta 196 filmom obloženih tableta
If you have been taking an ACE inhibitor, wait for 36 hours after taking the last dose before you start to take Entresto (see “Other medicines and Entresto”). 
Ako uzimate ACE inhibitor, pričekajte 36 sati nakon uzimanja posljednje doze prije nego počnete uzimati Entresto (vidjeti „Drugi lijekovi i Entresto“).
14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 56 film-coated tablets 196 film-coated tablets 
Filmom obložena tableta 14 filmom obloženih tableta 20 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 196 filmom obloženih tableta
Pack sizes: 14, 20, 28, 56, 168 or 196 film-coated tablets and multipacks containing 168 (3x56) or 196 (7x28) film-coated tablets. 
Veličine pakiranja: 14, 20, 28, 56, 168 ili 196 filmom obloženih tableta i višestruka pakiranja koja sadrže 168 (3x56) ili 196 (7x28) filmom obloženih tableta.
Entresto 97 mg/103 mg film-coated tablets 
Entresto 97 mg/103 mg filmom obložene tablete
Entresto 24 mg/26 mg film-coated tablets 
Entresto 24 mg/26 mg filmom obložene tablete
Entresto 49 mg/51 mg film-coated tablets are pale yellow oval tablets with “NVR” on one side and “L1” on the other side. 
Entresto 49 mg/51 mg filmom obložene tablete su blijedo žute ovalne tablete s oznakom „NVR“ s jedne strane i „L1“ s druge strane.
Entresto 24 mg/26 mg film-coated tablets Entresto 49 mg/51 mg film-coated tablets Entresto 97 mg/103 mg film-coated tablets 
Entresto 24 mg/26 mg filmom obložene tablete Entresto 49 mg/51 mg filmom obložene tablete Entresto 97 mg/103 mg filmom obložene tablete
Entresto 49 mg/51 mg film-coated tablets 
Entresto 49 mg/51 mg filmom obložene tablete
In PARADIGM-HF, renal impairment was reported in 10.1% of Entresto-treated patients and 11.5% of enalapril-treated patients. 
U ispitivanju PARADIGM-HF, oštećenje bubrega je prijavljeno u 10,1% bolesnika liječenih Entrestom te u 11,5% bolesnika liječenih enalaprilom.
Pack sizes: 14, 20, 28, 56 or 196 film-coated tablets and multipacks containing 196 (7x28) film-coated tablets. 
Veličine pakiranja: 14, 20, 28, 56 ili 196 filmom obloženih tableta i višestruka pakiranja koja sadrže 196 (7x28) filmom obloženih tableta.
≥49 mg sacubitril/51 mg valsartan/kg/day (≤0.72-fold the maximum recommended human dose [MRHD] on the basis of AUC) and rabbits at doses ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day (2-fold and 0.03-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively). 
Liječenje Entrestom tijekom organogeneze rezultiralo je povećanom embriofetalnom smrtnosti u štakora pri dozama ≥49 mg sakubitrila/51 mg valsartana/kg/dan (≤0,72 puta najveće preporučene doze za ljude [MRHD] na temelju AUC-a) i u zečeva pri dozama ≥4,9 mg sakubitrila/5,1 mg valsartana/kg/dan (2 odnosno 0,03 puta MRHD-a na temelju AUC-a valsartana, odnosno LBQ657).
Entresto 24 mg/26 mg film-coated tablets Entresto 49 mg/51 mg film-coated tablets Entresto 97 mg/103 mg film-coated tablets sacubitril/valsartan 
Entresto 24 mg/26 mg filmom obložene tablete Entresto 49 mg/51 mg filmom obložene tablete Entresto 97 mg/103 mg filmom obložene tablete sakubitril/valsartan
Entresto should not be co-administered with an ACE inhibitor or an ARB. Due to the potential risk of angioedema when used concomitantly with an ACE inhibitor, it must not be started for at least 36 hours after discontinuing ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5). 
Zbog potencijalnog rizika od angioedema kada se primjenjuje istodobno s ACE inhibitorom, on se ne smije uvesti u terapiju najmanje 36 sati nakon prekida terapije ACE inhibitorom (vidjeti dijelove 4.3, 4.4 i 4.5).
Entresto must not be administered until 36 hours after discontinuing ACE inhibitor therapy. 
Entresto se ne smije primjenjivati do 36 sati nakon prekida terapije ACE inhibitorom.
If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Entresto (see “Do not take Entresto”). 
Ako uzimate ACE inhibitor, pričekajte 36 sati nakon uzimanja posljednje doze ACE inhibitora prije nego počnete uzimati Entresto (vidjeti „Uzimanje drugih lijekova“).
Therefore, when initiating therapy with Entresto in patients receiving metformin, the clinical status of the patient should be evaluated. 
Stoga je potrebno ocijeniti klinički status bolesnika kada se započinje terapija Entrestom u bolesnika koji primaju metformin.
Entresto contains valsartan, and therefore should not be co-administered with another ARB containing product (see section 4.4). 
Interakcije koje rezultiraju time da se ne preporučuje istodobna primjena Entresto sadrži valsartan pa se stoga ne smije primjenjivati zajedno s drugim lijekom koji sadrži ARB (vidjeti dio 4.4).
In a 7-day valsartan-controlled study in patients with reduced ejection fraction (HFrEF), administration of Entresto resulted in an initial increase in natriuresis, increased urine cGMP, and decreased plasma levels of mid-regional pro-atrial natriuretic peptide (MR-proANP) and N-terminal prohormone brain natriuretic peptide (NT-proBNP) compared to valsartan. 
povećanjem koncentracije cGMP-a u mokraći te smanjenim razinama u plazmi srednje-regionalnog proatrijalnog natriuretskog peptida (MR-proANP) i N-terminalnog prohormona moždanog natriuretskog peptida (NT-proBNP) u usporedbi s valsartanom.
Therefore, co-administration of Entresto with inhibitors of OATP1B1, OATP1B3, OAT3 (e.g. rifampicin, ciclosporin), OAT1 (e.g. tenofovir, 
Stoga istodobna primjena Entresta s inhibitorima OATP1B1, OATP1B3, OAT3 (npr. rifampicinom, ciklosporinom), OAT1 (npr. tenofovirom, cidofovirom) ili MRP2 (npr. ritonavirom) može povećati sistemsku izloženost LBQ657 ili valsartanu.
What Entresto looks like and contents of the pack Entresto 24 mg/26 mg film-coated tablets are violet-white oval tablets with “NVR” on one side and “LZ” on the other side. 
Entresto 24 mg/26 mg filmom obložene tablete su ljubičasto bijele ovalne tablete s oznakom „NVR“ s jedne strane i „LZ“ s druge strane.
Entresto must not be started until 36 hours after taking the last dose of ACE inhibitor therapy. 
Entresto se ne smije započinjati do 36 sati nakon uzimanja zadnje doze terapije ACE inhibitorom.
Entresto 49 mg/51 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000 
Entresto 49 mg/51 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
The combination of Entresto with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see sections 4.3 and 4.5). 
Kombinacija Entresta s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m (vidjeti dijelove 4.3 i 4.5).
Entresto 97 mg/103 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000 
Entresto 97 mg/103 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
The concomitant use of Entresto with aliskiren-containing products is contraindicated in patients with diabetes mellitus or in patients with renal impairment (eGFR <60 ml/min/1.73 m2) (see section 4.3). 
Istodobna primjena Entresta i lijekova koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolesti ili u bolesnika s oštećenjem bubrega (eGFR <60 ml/min/1,73 m2) (vidjeti dio 4.3).
Entresto 24 mg/26 mg film-coated tablets Hypromellose, substitution type 2910 (3 mPa·s) Titanium dioxide (E171) Macrogol 4000 
Entresto 24 mg/26 mg filmom obložene tablete Hipromeloza, supstitucijski tip 2910 (3 mPa s) Titanijev dioksid (E171) Makrogol 4000
Entresto 97 mg/103 mg tablets sacubitril/valsartan 
Entresto 97 mg/103 mg tablete sakubitril/valsartan
Entresto 24 mg/26 mg tablets sacubitril/valsartan 
Entresto 24 mg/26 mg tablete sakubitril/valsartan
Approximate tablet dimensions 13.1 mm x 5.2 mm Entresto 97 mg/103 mg film-coated tablets are light pink oval tablets with “NVR” on one side and “L11” on the other side. 
Entresto 97 mg/103 mg filmom obložene tablete su svijetlo ružičaste ovalne tablete s oznakom „NVR“ s jedne strane i „L11“ s druge strane.
Entresto 24 mg/26 mg film-coated tablets sacubitril/valsartan 
Entresto 24 mg/26 mg filmom obložene tablete sakubitril/valsartan
Entresto 97 mg/103 mg film-coated tablets sacubitril/valsartan 
Entresto 97 mg/103 mg filmom obložene tablete sakubitril/valsartan
Entresto 49 mg/51 mg tablets sacubitril/valsartan 
Entresto 49 mg/51 mg tablete sakubitril/valsartan
If you stop taking Entresto, wait 36 hours after taking your last dose of Entresto before starting an ACE inhibitor. 
Ako prestanete uzimate Entresto, pričekajte 36 sati nakon uzimanja posljednje doze Entresta prije nego počnete uzimati ACE inhibitor (vidjeti „Uzimanje drugih lijekova“).
Entresto 49 mg/51 mg film-coated tablets sacubitril/valsartan 
Entresto 49 mg/51 mg filmom obložene tablete sakubitril/valsartan
A slight increase in two foetal skeletal variations (misshapen sternebra, sternebra bipartite ossification) was observed in rabbits at an Entresto dose of 
Blago povećanje dviju varijacija fetusnog skeleta (deformirana sternebra, dvostrana osifikacija sternebre) bilo je uočeno u zečeva pri dozi Entresta od 4,9 mg sakubitrila/5,1 mg valsartana/kg/dan.
The infusion lasts 2 hours. 
Infuzija mora trajati 2 sata.
This reduces bone loss. 
Time se smanjuje gubitak kostiju.
Patients should also take vitamin D and calcium supplements. 
Bolesnici također moraju uzimati vitamin D i dodatke kalcija.
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. 
Objašnjava kako je Agencija procijenila lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
The full EPAR for Ibandronic acid Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Ibandronatna kiselina Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for the reference medicines can also be found on the Agency's website. 
Cjeloviti EPAR za referentne lijekove nalazi se i na internetskim stranicama Agencije.
This will normally bring the blood calcium level down to normal levels within a week. 
To u pravilu razine kalcija u krvi vraća u normalu unutar tjedan dana.
This means that Ibandronic acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU). 
To znači da Ibandronatna kiselina Accord sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU).
For the prevention of skeletal events or the treatment of hypercalcaemia in cancer patients, treatment with this medicine should only be started by a doctor who has experience in the treatment of cancer. 
Za sprječavanje koštanih problema ili liječenje hiperkalcemije u oboljelih od raka, terapiju ovim lijekom može započeti samo liječnik s iskustvom u liječenju raka.
• prevent ‘skeletal events' (fractures or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone); 
• sprječavanje „koštanih problema” (fraktura ili komplikacija s kostima koje zahtijevaju liječenje u bolesnika s rakom dojke i metastazama u kostima (kad se rak proširio na kosti);
• treat hypercalcaemia (high levels of calcium in the blood) caused by tumours. 
• liječenje hiperkalcemije (visoke razine kalcija u krvi) koju uzrokuju tumori.
Its effect in reducing the risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established. 
Njegov učinak na smanjenje rizika od fraktura kralježnice utvrđen je u ispitivanjima, no učinak dotičnog lijeka na rizik od fraktura vrha femura (bedrene kosti) nije utvrđen.
Patients with tumours can have high levels of calcium in their blood, released from the bones. 
Bolesnici s tumorima mogu imati visoke količine kalcija u krvi koji se izlučuje iz kostiju.