FrancophonIA/ELRC3.0 huggingface dataset:
English: Concurrent administration of other medicinal products known to reduce serum calcium and Parsabiv may result in an increased risk of hypocalcaemia (see section 4.4).
Croatian: Istodobna primjena lijeka Parsabiv i drugih lijekova za koje je poznato da snižavaju razinu kalcija u serumu može rezultirati povećanim rizikom od hipokalcijemije (vidjeti dio 4.4).
English: 1 vial (0.5 mL) 6 vials (0.5 mL) 12 vials (0.5 mL) 42 vials (0.5 mL)
Croatian: 1 bočica (0,5 ml) 6 bočica (0,5 ml) 12 bočica (0,5 ml) 42 bočice (0,5 ml)
English: Administer Parsabiv with caution in patients receiving any other medicinal products known to lower serum calcium.
Croatian: Potrebno je uz oprez primjenjivati Parsabiv u bolesnika koji primaju bilo koje druge lijekove za koje je poznato da snižavaju razinu kalcija u serumu.
English: • Stop Parsabiv until corrected serum calcium levels are ≥ 8.3 mg/dL (2.08mmol/L) and symptoms of hypocalcaemia (if present) have resolved.
Croatian: • Prekinuti primjenu lijeka Parsabiv dok razine korigiranog kalcija u serumu ne budu ≥ 8,3 mg/dl (2,08 mmol/l) i dok se ne povuku simptomi hipokalcijemije (ako su prisutni).
English: Corrected serum calcium Mean percent change during the EAP, % (SE)
Croatian: Korigirani kalcij u serumu Srednja postotna promjena tijekom razdoblja procjene djelotvornosti, % (SE)
English: They were mild to moderate in severity and transient in nature in the majority of patients.
Croatian: U većine bolesnika bile su blage do umjerene težine i prolazne prirode.
English: No special temperature storage requirements are needed.
Croatian: Lijek ne zahtijeva čuvanje na određenoj temperaturi.
English: MedDRA system organ class (SOC)
Croatian: Klasifikacija organskih sustava prema MedDRA-i
English: Tell your doctor if you are breast-feeding or plan to do so.
Croatian: Obavijestite svog liječnika ako dojite ili planirate dojiti.
English: The median average weekly dose of Parsabiv during the EAP was 15.0 mg (5.0 mg per administration) and of cinacalcet was 360.0 mg (51.4 mg per administration).
Croatian: Medijan prosječne tjedne doze lijeka Parsabiv tijekom razdoblja procjene djelotvornosti iznosio je 15,0 mg (5,0 mg po primjeni), a cinakalceta 360,0 mg (51,4 mg po primjeni).
English: 5 Symptomatic reductions in serum cCa < 8.3 mg/dL (2.08 mmol/L).
Croatian: 5 Simptomatska sniženja razine korigiranog kalcija u serumu < 8,3 mg/dl (2,08 mmol/l).
English: Parsabiv should not be initiated if corrected serum calcium is less than the lower limit of the normal range (see sections 4.2 and 4.4).
Croatian: Primjena lijeka Parsabiv ne smije se započeti ako je vrijednost korigiranog kalcija u serumu niža od donje granice normalnog raspona (vidjeti dijelove 4.2 i 4.4).
English: Mean (SE) baseline PTH concentrations across the 2 studies were 846.9 (21.8) pg/mL, and 835.9 (21.0) pg/mL for the Parsabiv and placebo groups, respectively with approximately 21% of subjects enrolling across both studies having baseline PTH > 1,000 pg/mL.
Croatian: Srednja vrijednost (standardna pogreška, SE) početne koncentracije PTH u 2 ispitivanja bila je 846,9 (21,8) pg/ml za skupinu koja je primala Parsabiv, te 835,9 (21,0) pg/ml za skupinu na placebu, uz približno 21% ispitanika uključenih u oba ispitivanja s početnom razinom PTH > 1000 pg/ ml.
English: QTc prolongation secondary to hypocalcaemia
Croatian: Produljenje QTc intervala kao posljedica hipokalcijemije
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Parsabiv 2.5 mg solution for injection
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Parsabiv 2,5 mg otopina za injekciju
English: 1 vial (1 mL) 6 vials (1 mL) 12 vials (1 mL) 42 vials (1 mL)
Croatian: 1 bočica (1 ml) 6 bočica (1 ml) 12 bočica (1 ml) 42 bočice (1 ml)
English: Mean percent change during the EAP, % (SE)
Croatian: Srednja postotna promjena tijekom razdoblja procjene djelotvornosti, % (SE)
English: In the combined placebo-controlled studies, a higher percentage of patients in the Parsabiv group compared with the placebo group had a maximum increase from baseline of > 60 msec in the QTcF interval (1.2% Parsabiv; 0% placebo).
Croatian: U kombiniranim placebom kontroliranim ispitivanjima, udio bolesnika u kojih je maksimalno produljenje QTcF intervala u odnosu na početnu vrijednost bilo > 60 msec bio je viši u skupini koja je primala Parsabiv, u usporedbi sa skupinom na placebu (1,2% Parsabiv ; 0% placebo).
English: Parsabiv contains less than 1 mmol sodium per vial, that is to say essentially sodium-free.
Croatian: Parsabiv sadrži manje od 1 mmol natrija po bočici, tj. zanemarive količine natrija.
English: Patients receiving Parsabiv should not be given cinacalcet.
Croatian: Parsabiv ne smije se dati cinakalcet.
English: If patient's last administered dose was 2.5 mg or 5 mg, reinitiate at 2.5 mg once corrected serum calcium levels are ≥ 8.3 mg/dL (2.08 mmol/L) and symptoms of hypocalcaemia (if present) have resolved.
Croatian: Ako je zadnja primijenjena doza u bolesnika bila 2,5 mg ili 5 mg, ponovno započeti primjenu u dozi od 2,5 mg, kada razine korigiranog kalcija u serumu budu ≥ 8,3 mg /dl (2,08 mmol/l) i kada se povuku simptomi hipokalcijemije (ako su prisutni).
English: Parsabiv treatment should not be initiated in patients if the corrected serum calcium is less than the lower limit of the normal range (see section 4.3).
Croatian: Primjena lijeka Parsabiv u bolesnika ne smije se započeti ako je vrijednost korigiranog kalcija u serumu niža od donje granice normalnog raspona (vidjeti dio 4.3).
English: 1 vial (2 mL) 6 vials (2 mL) 12 vials (2 mL) 42 vials (2 mL)
Croatian: 1 bočica (2 ml) 6 bočica (2 ml) 12 bočica (2 ml) 42 bočice (2 ml)
English: You may need to take calcium and vitamin D supplements while being treated with Parsabiv.
Croatian: Možda ćete morati uzimati nadomjestke kalcija i vitamina
English: For patients in whom the dose is stopped, Parsabiv should be reinitiated at a lower dose once PTH returns to > 150 pg/mL (15.9 pmol/L) and pre-dialysis serum corrected calcium (cCa) ≥ 8.3 mg/dL (2.08 mmol/L).
Croatian: Za bolesnike u kojih je primjena privremeno prekinuta, treba ponovno započeti primjenu lijeka Parsabiv pri nižoj dozi, kada se razina PTH vrati na vrijednost > 150 pg/ml (15,9 pmol/l) i vrijednost korigiranog kalcija u serumu (cCa) prije dijalize iznosi ≥ 8,3 mg /dl (2,08 mmol/l).
English: Hypocalcaemia1, 5
Croatian: Često hipokalcijemija1, 5 hiperkalijemija2 hipofosfatemija
English: Each vial contains 2 mL solution for injection.
Croatian: Svaka bočica sadrži 2 ml otopine za injekciju.
English: Each vial contains 0.5 mL solution for injection.
Croatian: Svaka bočica sadrži 0,5 ml otopine za injekciju.
English: The primary endpoint was non-inferiority for the proportion of patients who achieved > 30% reduction from baseline in mean PTH during the EAP (weeks 20 to 27).
Croatian: Mjera primarnog ishoda bila je neinferiornost za udio bolesnika koji su postigli sniženje srednje razine PTH od > 30% u odnosu na početnu vrijednost tijekom razdoblja procjene djelotvornosti (20. do 27. tjedan).
English: The primary endpoint in each study was the proportion of patients with > 30% reduction from baseline in PTH during the EAP (EAP, defined as weeks 20 to 27 inclusive).
Croatian: Mjera primarnog ishoda oba ispitivanja bila je udio bolesnika sa sniženjem razine PTH u odnosu na početnu vrijednost od > 30% tijekom razdoblja procjene djelotvornosti (definirano kao razdoblje od 20. do 27. tjedna, uključujući i njih).
English: The patient incidence of maximum post-baseline pre-dialysis QTcF > 500 msec in the Parsabiv and placebo groups was 4.8% and 1.9%, respectively.
Croatian: Incidencija bolesnika u kojih je maksimalna vrijednost QTcF intervala nakon početka liječenja i prije dijalize iznosila > 500 msec bila je 4,8% u skupini koja je primala Parsabiv i 1,9% u skupini na placebu.
English: In the population pharmacokinetics model, volume of distribution at steady-state was approximately 796 L. Etelcalcetide is predominately bound to plasma albumin by reversible covalent binding.
Croatian: U populacijskom farmakokinetičkom modelu, volumen distribucije u stanju dinamičke ravnoteže iznosio je približno 796 l.
English: The secondary endpoints were the proportion of patients with a mean PTH ≤ 300 pg/mL during the EAP, and percent change from baseline during the EAP for PTH, serum cCa, phosphate and calcium phosphate product (Ca x P).
Croatian: Mjere sekundarnih ishoda bile su udio bolesnika čija je srednja razina PTH tijekom razdoblja procjene djelotvornosti bila ≤ 300 pg/ml, te postotak promjene razine PTH, cCa u serumu, fosfata i produkta koncentracije kalcija i fosfata (Ca x P) u odnosu na početnu vrijednost tijekom razdoblja procjene djelotvornosti.
English: Corrected serum calcium should be at or above the lower limit of the normal range prior to administration of first dose of Parsabiv, a dose increase, or reinitiation after a dose stop (see also dose adjustments based on serum calcium levels).
Croatian: Prije primjene prve doze lijeka Parsabiv, povećanja doze ili ponovnog uvođenja liječenja nakon privremenog prekida primjene, korigirani kalcij u serumu treba biti na ili iznad donje granice normalnog raspona (vidjeti i prilagodbu doze na temelju razine kalcija u serumu).
English: Mean (SE) baseline PTH concentrations were 1,092.12 (33.8) and 1,138.71 (38.2) pg/mL for the Parsabiv and cinacalcet groups respectively.
Croatian: Srednje vrijednosti (standardna pogreška, SE) početnih koncentracija PTH bile su 1092,12 (33,8) pg/ml za skupinu koja je primala Parsabiv i 1138,71 (38,2) pg/ml za skupinu koja je primala cinakalcet.
English: In secondary hyperparathyroidism too much PTH is produced by the parathyroid glands (four small glands in the neck).
Croatian: Kod sekundarnog hiperparatireoidizma paratireoidne žlijezde (četiri male žlijezde u vratu) stvaraju previše PTH. „Sekundarni“ znači da je hiperparatireoidizam prouzročen drugim stanjem, npr. bolešću bubrega.
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents.
Croatian: Farmakoterapijska skupina: pripravci s utjecajem na mijenu kalcija, antiparatireoidne tvari.
English: Serum calcium levels should be closely monitored in patients with a history of a convulsion disorder while being treated with Parsabiv.
Croatian: Razine kalcija u serumu treba pomno pratiti tijekom liječenja lijekom Parsabiv u bolesnika s konvulzivnim poremećajem u anamnezi.
English: Each vial contains 1 mL solution for injection.
Croatian: Svaka bočica sadrži 1 ml otopine za injekciju.
English: If the patient's last administered dose was 2.5 mg, Parsabiv may be reinitiated at the 2.5 mg dose level if PTH is > 300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa ≥ 8.3 mg/dL (2.08 mmol/L).
Croatian: Ako je posljednja primijenjena doza u bolesnika iznosila 2,5 mg, može se ponovno započeti primjena lijeka Parsabiv pri dozi od 2,5 mg nakon što se razina PTH vrati na > 300 pg /ml (31,8 pmol/l) i najnovija vrijednost cCa u serumu prije dijalize iznosi ≥ 8,3 mg /dl (2,08 mmol/l).
English: There are no or limited amount of data from the use of etelcalcetide in pregnant women.
Croatian: Podaci o primjeni etelkalcetida u trudnica su ograničeni ili ne postoje.
English: Both studies demonstrated that Parsabiv reduced PTH, while lowering calcium, phosphate and Ca x P. Results of all primary and secondary endpoints were statistically significant and the results were consistent across both studies as shown in table 2.
Croatian: Rezultati svih primarnih i sekundarnih mjera ishoda bili su statistički značajni i dosljedni u oba ispitivanja, kako je prikazano u Tablici 2.
English: Open-label extension study
Croatian: Otvoreni nastavak ispitivanja
English: Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide in 2 mL solution (5 mg/mL).
Croatian: Parsabiv 10 mg otopina za injekciju: Svaka bočica sadrži 10 mg etelkalcetida u 2 ml otopine (5 mg/ml).
English: If PTH levels decrease below the recommended target range, the dose of vitamin D sterols and/or Parsabiv should be reduced or therapy discontinued.
Croatian: Ako se razine PTH snize ispod preporučenog ciljnog raspona, treba smanjiti dozu sterola vitamina
English: Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide in 1 mL solution (5 mg/mL).
Croatian: Parsabiv 5 mg otopina za injekciju: Svaka bočica sadrži 5 mg etelkalcetida u 1 ml otopine (5 mg/ml).
English: Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide in 0.5 mL solution (5 mg/mL).
Croatian: Parsabiv 2,5 mg otopina za injekciju: Svaka bočica sadrži 2,5 mg etelkalcetida u 0,5 ml otopine (5 mg/ml).
English: Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection etelcalcetide
Croatian: Parsabiv 2,5 mg otopina za injekciju Parsabiv 5 mg otopina za injekciju Parsabiv 10 mg otopina za injekciju etelkalcetid
English: Adynamic bone may develop if PTH levels are chronically suppressed below 100 pg/mL.
Croatian: Ako su razine PTH kronično snižene ispod 100 pg/ml može se razviti adinamična koštana bolest.
English: Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution.
Croatian: Svaka bočica sadrži 2,5 mg etelkalcetida (u obliku etelkalcetidklorida) u 0,5 ml otopine.
English: Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution.
Croatian: Svaka bočica sadrži 10 mg etelkalcetida (u obliku etelkalcetidklorida) u 2 ml otopine.
English: Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution.
Croatian: Svaka bočica sadrži 5 mg etelkalcetida (u obliku etelkalcetidklorida) u 1 ml otopine.
English: Parsabiv 2.5 mg solution for injection
Croatian: Parsabiv 2,5 mg otopina za injekciju
English: Parsabiv 10 mg solution for injection
Croatian: Parsabiv 10 mg otopina za injekciju
English: Parsabiv 2.5 mg solution for injection EU/1/16/1142/001 - 1 vial EU/1/16/1142/002 - 6 vials EU/1/16/1142/003 - 12 vials EU/1/16/1142/004 - 42 vials Parsabiv 5 mg solution for injection EU/1/16/1142/005 - 1 vial EU/1/16/1142/006 - 6 vials EU/1/16/1142/007 - 12 vials EU/1/16/1142/008 - 42 vials Parsabiv 10 mg solution for injection EU/1/16/1142/009 - 1 vial EU/1/16/1142/010 - 6 vials EU/1/16/1142/011 - 12 vials EU/1/16/1142/012 - 42 vials
Croatian: EU/1/16/1142/003 - 12 bočica EU/1/16/1142/004 - 42 bočice Parsabiv 5 mg otopina za injekciju EU/1/16/1142/005 - 1 bočica EU/1/16/1142/006 - 6 bočica EU/1/16/1142/007 - 12 bočica EU/1/16/1142/008 - 42 bočice
English: Parsabiv 5 mg solution for injection
Croatian: Parsabiv 5 mg otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection
Croatian: Parsabiv 2,5 mg otopina za injekciju Parsabiv 5 mg otopina za injekciju Parsabiv 10 mg otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 10 mg solution for injection etelcalcetide
Croatian: NAZIV LIJEKA Parsabiv 10 mg otopina za injekciju etelkalcetid
English: Patients with lower screening PTH levels were more likely to reach PTH ≤ 300 pg/mL during EAP.
Croatian: Vjerojatnost postizanja razine PTH ≤ 300 pg/ml tijekom razdoblja procjene djelotvornosti bila je veća u bolesnika s nižim razinama PTH prilikom probira.
English: Nausea Vomiting Diarrhoea
Croatian: Vrlo često mučnina povraćanje proljev
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of etelcalcetide (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 10 mg etelkalcetida (u obliku etelkalcetidklorida).
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 5 mg solution for injection etelcalcetide
Croatian: NAZIV LIJEKA Parsabiv 5 mg otopina za injekciju etelkalcetid
English: Reductions in serum calcium associated with tremoring,
Croatian: Pri razinama kliničke izloženosti opažena su sniženja razine kalcija u serumu povezana s tremorom, konvulzijama i nalazima povezanima sa stresom.
English: The pharmacokinetics of etelcalcetide was characterised in CKD patients receiving haemodialysis.
Croatian: Farmakokinetika etelkalcetida određena je u bolesnika s KBB-om koji su na hemodijalizi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2.5 mg of etelcalcetide (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 2,5 mg etelkalcetida (u obliku etelkalcetidklorida).
English: Etelcalcetide is intended for CKD patients receiving haemodialysis.
Croatian: Etelkalcetid je namijenjen liječenju bolesnika s KBB-om koji su na hemodijalizi.
English: Single doses up to 60 mg and multiple doses up to 22.5 mg 3 times a week at the end of dialysis in patients receiving haemodialysis were safely administered in clinical trials.
Croatian: U kliničkim ispitivanjima, u bolesnika koji su na hemodijalizi, sigurno su primjenjivane jednokratne doze od najviše 60 mg i višekratne doze od najviše 22,5 mg 3 puta tjedno na kraju dijalize.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of etelcalcetide (as hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka bočica sadrži 5 mg etelkalcetida (u obliku etelkalcetidklorida).
English: • Muscle pain
Croatian: • Grčevi mišića
English: If you start to get numbness or tingling around your mouth or in your extremities, muscle aches or cramps and seizures (fits), you should tell your doctor immediately.
Croatian: Odmah obavijestite svog liječnika ako počnete osjećati utrnulost ili trnce oko usta ili u udovima, bolove u mišićima ili grčeve i napadaje.
English: This medicinal product must not be mixed with other medicinal products.
Croatian: Natrijev hidroksid (za prilagođavanje pH) 6.2 Inkompatibilnosti Lijek se ne smije miješati s drugim lijekovima.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 2.5 mg solution for injection etelcalcetide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Parsabiv 2,5 mg otopina za injekciju etelkalcetid i.v.
English: Metabolism and nutrition disorders Very common
Croatian: Poremećaji metabolizma i prehrane Vrlo često snižena razina kalcija u krvi1, 4
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 10 mg solution for injection etelcalcetide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Parsabiv 10 mg otopina za injekciju etelkalcetid i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 5 mg solution for injection etelcalcetide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Parsabiv 5 mg otopina za injekciju etelkalcetid i.v.
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection etelcalcetide
Croatian: Parsabiv 2,5 mg otopina za injekciju etelkalcetid
English: • Muscle spasms
Croatian: • Proljev
English: The full EPAR for Granpidam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Granpidam nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This was considered acceptable since Revatio and Viagra have the same composition and are made in the same way by the same manufacturer.
Croatian: To se smatralo prihvatljivim jer Revatio i Viagra imaju isti sastav i proizvodi ih isti proizvođač na isti način.
English: In children weighing less than 20 kg the maximum recommended
Croatian: U djece koja imaju manje od 20 kg najveća
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom preporučena doza jest 10 mg tri puta na dan, no lijek Granpidam smije se primjenjivati samo kada je potrebno dati dozu od 20 mg.
English: In this case Granpidam was not compared with the reference product Revatio, but with Viagra.
Croatian: U ovom slučaju lijek Granpidam nije uspoređen s referentnim proizvodom Revatio, nego s proizvodom Viagra.
English: This is a summary of the European public assessment report (EPAR) for Granpidam.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Granpidam.
English: What is Granpidam and what is it used for?
Croatian: Što je Granpidam i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Granpidam?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Granpidam?
English: The active substance in Granpidam, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Croatian: Djelatna tvar u lijeku Granpidam, sildenafil, ubraja se u skupinu lijekova koji se nazivaju „inhibitori fosfodiesteraze tipa 5 (PDE5)”, što znači da onemogućuju djelovanje enzima PDE5.
English: Because Granpidam is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Granpidam generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This means that Granpidam is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio.
Croatian: To znači da je lijek Granpidam sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Revatio.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Granpidam was considered to be comparable to Revatio.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, dokazano da je lijek Granpidam usporediv s lijekom Revatio.
English: When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Croatian: Kada se onemogući njegovo djelovanje, tvar koja se naziva „ciklički gvanin monofosfat” (cGMP) ne može se razgraditi i stoga ostaje u žilama u kojima uzrokuje opuštanje i širenje krvnih žila.
English: Other information about Granpidam
Croatian: Ostale informacije o lijeku Granpidam
English: Granpidam is available as tablets (20 mg).
Croatian: Lijek Granpidam dostupan je u obliku tableta (od 20 mg).
English: Granpidam can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Croatian: Lijek Granpidam izdaje se samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju PAH-a.
English: Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Croatian: Budući da su djelotvornost i sigurnost sildenafila u bolesnika s PAH-om već dokazani, ispitivanja u ljudi bila su ograničena na ispitivanja u svrhu utvrđivanja bioekvivalentnosti s drugim odobrenim tabletama koje sadržavaju sildenafil.
English: For lower doses, other medicines containing sildenafil should therefore be used.
Croatian: Za niže je doze stoga potrebno primjenjivati druge lijekove koji sadržavaju sildenafil.
English: Granpidam is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries in the lungs).
Croatian: Granpidam je lijek koji se primjenjuje u liječenju odraslih osoba i djece u dobi od jedne i više godina s plućnom arterijskom hipertenzijom (PAH, abnormalno visok krvni tlak u plućnim arterijama).
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Croatian: PAH je onesposobljavajuća bolest pri kojoj postoji ozbiljna konstrikcija (suženje) krvnih žila u plućima.