natgillin/translations-raw huggingface dataset:
Further information on Opsumit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Više informacija o lijeku Opsumit možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In a main study involving 742 patients, Opsumit has been shown to reduce the risk of PAH-related illness, particularly the worsening of PAH symptoms. 
U glavnom ispitivanju u kojem su sudjelovala 742 bolesnika dokazano je da Opsumit smanjuje rizik od bolesti povezanih s PAH-om, posebno od pogoršavanja simptoma PAH-a.
Other information about Opsumit 
Ostale informacije o lijeku Opsumit
Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg. 
Približno 37 % bolesnika koji su uzimali placebo doživjeli su pogoršanje simptoma PAH-a u odnosu na 24 % bolesnika koji su uzimali Opsumit od 10 mg.
Side effects reported with Opsumit are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Opsumit pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH). 
Opsumit je lijek koji se koristi za dugoročno liječenje plućne arterijske hipertenzije (PAH).
What are the risks associated with Opsumit? 
Koji su rizici povezani s lijekom Opsumit?
Why is Opsumit authorised in the EU? 
Zašto je lijek Opsumit odobren u EU-u?
The European Medicines Agency decided that Opsumit's benefits are greater than its risks and it can be authorised for use in the EU. 
Europska agencija za lijekove zaključila je da koristi od lijeka Opsumit nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood. 
Ne smije se primjenjivati u bolesnika s ozbiljnim oštećenjem funkcije jetre ili visokim razinama jetrenih enzima u krvi.
As for all medicines, data on the use of Opsumit are continuously monitored. 
Kao za sve lijekove, podatci o primjeni lijeka Opsumit kontinuirano se prate.
An overview of Opsumit and why it is authorised in the EU 
Pregled informacija o lijeku Opsumit i zašto je odobren u EU-u
Further information on the orphan designation can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Više informacija lijekovima za rijetke bolesti nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Because more pressure is needed to force blood through the narrowed artery, this leads to high blood pressure in the lungs. 
Budući da je potreban veći tlak za pumpanje krvi kroz suženu arteriju, dolazi do visokog krvnog tlaka u plućima.
The class reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity. 
Razred odražava ozbiljnost bolesti: bolesnici s PAH-om razvrstanim u razred II. imaju neznatno ograničenje fizičke aktivnosti, dok oni čija je bolest razvrstana u razred III. imaju značajno ograničenje fizičke aktivnosti.
Opsumit received a marketing authorisation valid throughout the EU on 20 December 2013. 
Lijek Opsumit dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 20. prosinca 2013.
Opsumit can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in treating PAH. 
Opsumit se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u liječenju PAH-a.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opsumit have also been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Opsumit također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
Opsumit contains the active substance macitentan. 
Opsumit sadržava djelatnu tvar macitentan.
PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. 
PAH je stanje s abnormalno visokim krvnim tlakom u plućnim arterijama koje uzrokuje simptome kao što su nedostatak daha i umor.
Opsumit can be used alone or in combination with other PAH medicines; for further information, see the package leaflet. 
Opsumit se može koristiti samostalno ili u kombinaciji s drugim lijekovima protiv PAH-a; dodatne informacije potražite u uputi o lijeku.
The company that markets Opsumit will send educational material to patients and healthcare professionals with information on the precautions to be taken when using Opsumit. 
Tvrtka koja na tržište stavlja lijek Opsumit bolesnicima i zdravstvenim radnicima poslat će edukativni materijal s informacijama o mjerama opreza potrebnim pri primjeni lijeka Opsumit.
Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception. 
Opsumit se stoga ne smije upotrebljavati u trudnica, dojilja ili žena koje mogu zatrudnjeti i koje ne primjenjuju pouzdanu kontracepciju.
However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women or women who could become pregnant and are not using reliable contraception. 
No, budući da je u ispitivanjima na životinjama otkriven štetan učinak na razvoj embrija, Opsumit se nikada ne smije primjenjivati u trudnica ili žena koje bi mogle zatrudnjeti i ne koriste pouzdanu kontracepciju.
Patients' reminder cards will include a warning that the medicine must never be used in pregnant women and that women who could become pregnant must be using reliable contraception and should undergo monthly pregnancy tests. 
Kartice s podsjetnikom za bolesnike sadržavat će upozorenje da se lijek nikada ne smije primjenjivati u trudnica te da žene koje bi mogle zatrudnjeti moraju koristiti pouzdanu metodu kontracepcije i raditi testove na trudnoću svakog mjeseca.
Opsumit is used for adults whose PAH is classified as WHO functional class II to class III. 
Opsumit se koristi u odraslih bolesnika čiji je PAH označen kao bolest funkcionalnog razreda II. do III. prema klasifikaciji Svjetske zdravstvene organizacije.
For more information about using Opsumit, see the package leaflet or contact your doctor or pharmacist. 
Više informacija o primjeni lijeka Opsumit pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
Opsumit has been shown to be effective in reducing illness or deaths due to PAH and the side effects reported are similar to those reported with other medicines of its class and are considered to be manageable. 
Pokazalo se da je Opsumit djelotvoran u smanjenju bolesti ili smrtnih slučajeva povezanih s PAH-om, a zabilježene nuspojave slične su nuspojavama drugih lijekova iz njegova razreda te se smatraju prihvatljivima.
The active substance in Opsumit, macitentan, works by blocking endothelin receptors. 
Djelatna tvar u lijeku Opsumit, macitentan, djeluje inhibirajući endotelinske receptore.
Patients in the study received either Opsumit or placebo (a dummy treatment) in addition to other PAH treatments for an average of 2 years. 
Bolesnici koji su sudjelovali u ispitivanju primali su Opsumit ili placebo (prividni lijek) uz druge lijekove protiv PAH-a u prosjeku 2 godine.
In patients with PAH, this mechanism is overactive and, by blocking these receptors, macitentan helps widen the arteries in the lungs and thereby bring down the blood pressure. 
U bolesnika s plućnom arterijskom hipertenzijom taj je mehanizam prekomjerno aktivan, a inhibirajući navedene receptore Macitentan pomaže u proširenju plućnih arterija te snižava krvni tlak.
In PAH there is severe narrowing of the arteries of the lungs. 
PAH uzrokuje ozbiljno suženje plućnih arterija.
PAH is ‘rare', and Opsumit was designated an ‘orphan medicine' (a medicine used in rare diseases) for PAH on 27 September 2011. 
Plućna arterijska hipertenzija (PAH) rijetka je bolest, a Opsumit je dobio status lijeka za rijetku bolest PAH 27. rujna 2011.
Most side effects are mild to moderate in severity. 
Većina nuspojava blaga je do umjerena.
What benefits of Opsumit have been shown in studies? 
Koje su koristi lijeka Opsumit utvrđene u ispitivanjima?
How does Opsumit work? 
Kako djeluje Opsumit?
How is Opsumit used? 
Kako se Opsumit primjenjuje?
For the full list of side effects reported with Opsumit, see the package leaflet. 
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Opsumit potražite u uputi o lijeku.
When exposed to any of these viruses later in life, the cat will either not become infected or have a much less serious infection. 
Kada postane izložena tim virusima kasnije u životu, mačka ili neće postati zaražena ili će imati mnogo manje ozbiljnu infekciju.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses or bacteria. 
Ubuduće će imunosni sustav moći brže proizvoditi protutijela ako je izloženo stvarnim virusima ili bakterijama.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘foreign' and makes antibodies against them. 
Kad mačka primi cjepivo, imunosni sustav prepoznaje oslabljene ili ubijene viruse kao „strano tijelo” i proizvodi protutijela na njih.
It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study. 
Nije bilo moguće detektirati porast protutijela protivC. felis zbog visokih razina protutijela u mačaka na početku ispitivanja.
The main measure of effectiveness was the level of antibodies in the blood against the viruses and bacteria in the vaccine. 
Glavna mjera učinkovitosti bila je koncentracija protutijela u krvi naspram virusa i bakterija u cjepivu.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred. 
Ako se samoinjektiranje dogodi kod tih osoba, recite liječniku da se dogodilo samoinjektiranje živim klamidijalnim cjepivom.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCPCh exceed the risks for the approved indications and recommended that Purevax RCPCh be given a marketing authorisation. 
Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi cjepiva Purevax RCPCh premašuju rizike za odobrene indikacije i preporučio je izdavanje odobrenja za stavljanje u promet cjepiva Purevax RCPCh.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCPCh on 23 February 2005. 
Europska komisija izdala je odobrenje za stavljanje VMP-a Purevax RCPCh u promet koje je na snazi u Europskoj uniji od 23. veljače 2005.
Purevax RCPCh should not be used in pregnant cats. 
Purevax RCPCh ne smije se primjenjivati u gravidnih mačaka.
The cat should be revaccinated for all components one year after the first vaccination course, then every year for chlamydiosis, and every three years for rhinotracheitis, calicivirosis and panleucopenia. 
Mačku treba ponovno cijepiti za sve bolesti godinu dana nakon prvog cijepljenja, a potom svake godine za klamidiozu te svake tri godine za rinotraheitis, kalicivirozu i panleukopeniju.
Purevax RCPCh is used to vaccinate cats from the age of 8 weeks against the following diseases: 
Purevax RCPCh se koristi za cijepljenje mačaka u dobi od 8 tjedana nadalje protiv sljedećih bolesti:
• inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains), 
• inaktivirane (mrtve) antigene kaliciviroze (sojeve FCV 431 i G1).
The antibodies will help to protect against the diseases caused by these viruses or bacteria. 
To pomaže u zaštiti od bolesti koje uzrokuju virusi ili bakterije.
Purevax RCPCh is available as a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection. 
Purevax RCPCh je dostupan kao liofilizat (prašak smrznut sušenjem) i otapalo od kojih se pravi suspenzija za injekciju.
In the field, the studies of Purevax RCPCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination. 
Na terenu, ispitivanja cjepiva Purevax RCPCh fokusirala su se na temeljni raspored cijepljenja (2 injekcije u razmaku od 3 do 4 tjedna) te na docjepljivanje.
Purevax RCPCh is a veterinary vaccine that contains: 
Purevax RCP je veterinarsko cjepivo koje sadrži:
In laboratory conditions Purevax RCPCh was demonstrated to provide protection against the diseases listed above. 
U laboratorijskim uvjetima je dokazano da Purevax RCP osigurava zaštitu protiv prethodno spomenutih bolesti.
• attenuated feline panleucopenia virus (PLI IV). 
• oslabljeni virus mačje panleukopenije (PLI IV).
• attenuated Chlamydophila felis (905 strain), 
• oslabljene bakterije Chlamydophila felis (soj 905),
Purevax RCPCh contains small amounts of weakened or killed viruses and bacteria that cause feline rhinotracheitis, calicivirosis, chlamydiosis and panleucopenia. 
Purevax RCPCh sadrži male količine oslabljenih ili mrtvih virusa i bakterija koji uzrokuju mačji rinotraheitis, kalicivirozu, klamidiozu i panleukopeniju.
The effectiveness of Purevax RCPCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with herpesvirus, calicivirus, C. felis or parvovirus. 
Učinkovitost cjepiva Purevax RCPCh ispitivana je u nekoliko ispitivanja u laboratorijskim uvjetima gdje su mačke cijepljene i inficirane herpesvirusom, kalicivirusom, virusom C. felis ili parvovirusom.
Other information about Purevax RCPCh: 
Ostale informacije o VMP-u Purevax RCPCh:
What benefit has Purevax RCPCh shown during the studies? 
Koje je koristi Purevax RCP pokazao tijekom ispitivanja?
Purevax RCPCh is a vaccine. 
Purevax RCPCh je cjepivo.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection, feline panleucopenia and C. felis remained stable at a high level or increased slightly. 
U ispitivanju koje je ispitivalo docjepljivanje, razine protutijela na herpesvirus rinotraheitisa, infekciju kalicivirusom, mačju leukopeniju te C. felis ostale su stabilne pri visokim razinama ili su blago povećane.
What is the risk associated with Purevax RCPCh? 
Koji su rizici povezani s cjepivom Purevax RCPCh?
For a full list of the side-effects reported with Purevax RCPCh, see the package leaflet. 
Potpuni popis svih nuspojava i ograničenja pri primjeni VMP-a Purevax RCPCh potražite u uputi o VMP-u.
What is Purevax RCPCh? 
Što je Purevax RCPCh?
Feline viral rhinotracheitis, feline chlamydiosis, feline panleucopenia (live attenuated) and feline calicivirosis (inactivated) vaccine 
Cjepivo protiv mačjeg rinotraheitisa, mačje panleukopenije (živo oslabljeno) i mačje kaliciviroze (inaktivirano)
Why has Purevax RCPCh been approved? 
Zašto je lijek Purevax RCPCh odobren?
• feline chlamydiosis (a flu-like illness caused by the bacterium C. felis), 
• mačje klamidioze (bolesti nalik gripi koju uzrokuje C. felis),
What is Purevax RCPCh used for? 
Za što se koristi Purevax RCPCh?
How does Purevax RCPCh work? 
Kako djeluje Purevax RCPCh?
How has Purevax RCPCh been studied? 
Kako je lijek Purevax RCPCh ispitivan?
A further study was carried out in 15 female patients. 
Provedeno je daljnje ispitivanje u 15 ženskih bolesnika.
The full EPAR for Replagal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Cjeloviti EPAR za lijek Replagal nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Replagal is given once every 2 weeks as an infusion of 0.2 mg per kilogram body weight over 40 minutes. 
Replagal se primjenjuje jednom svakih 2 tjedna kao infuzija od 0,2 mg po kilogramu tjelesne težine tijekom 40 minuta.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015. 
Tvrtka je dostavila dodatne zatražene informacije, tako da je dodano „u iznimnim okolnostima” dana 20. srpnja 2015
Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above. 
Replagal je također ocijenjen u daljnjim ispitivanjima koja su obuhvatila 38 djece u dobi od 7 godina ili starijih.
Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval. 
Replagal je prvobitno odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Replagal na snazi u Europskoj uniji od 3. kolovoza 2001.
Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced. 
Djeca koja su primila lijek Replagal nisu imala neočekivanih povećanja u srčanoj masi, a koncentracije Gb3 u njihovoj krvi su se smanjile.
Replagal agalsidase alfa 
Replagal agalzidaza alfa
The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme. 
Djelatna tvar lijeka Replagal, agalzidaza alfa, jest kopija ljudskog enzima, proizvedena metodom poznatom pod nazivom "tehnologija rekombinantne DNK": proizvodi ga stanice koje su primile gen (DNK), koji im omogućuje stvaranje enzima.
For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Replagal pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo. 
Nakon 6 mjeseci terapije, Replagal je značajno smanjio bol u bolesnika u usporedbi s placebom.
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke. 
Osobe s Fabryjevom bolesti mogu imati široko raspon znakova i simptoma, uključujući ozbiljna stanja poput zatajenja bubrega, srčanih problema i moždanog udara.
Why has Replagal been approved? 
Zašto je Replagal odobren?
Other information about Replagal 
Ostale informacije o lijeku Replagal
These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe. 
Ove nuspojave uključuju zimicu, mučninu, pireksiju (vrućicu), bol i nelagodu, znojenje o iscrpljenost (umor), te su rijetko ozbiljne.
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 Replagal. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Replagal.
It is available as a concentrate to be made into solution for infusion (drip) into a vein. 
Postoji kao koncentrat za suspenziju za infuziju (drip u venu).
The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells. 
Prvo je ispitivanje izmjerilo djelovanje lijeka Replagal na bol dok je drugo ispitivanje izmjerilo njegovo djelovanje na masu lijevog ventrikula (srčanog mišića), mjera količine Gb3 u srčanim stanicama.
If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells. 
Ako enzim nije prisutan, Gb3 se ne može razgrađivati i ugrađuje se u stanice tijela poput stanica bubrega.
The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions. 
Najčešće nuspojave lijeka Replagal (može se javiti u više od 1 na 10 osoba) su reakcije povezane s infuzijom..
This is a summary of the European public assessment report (EPAR) for Replagal. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Replagal.
Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients. 
Replagal je uspoređen s placebom (prividnim terapijom) u dva glavna ispitivanja koja su obuhvatila ukupno 40 muških bolesnika.
The effect of giving doses weekly rather than every two weeks was also investigated. 
Istraženo je i djelovanje primjene tjednih doza u odnosu na primjenu svaka dva tjedna.
The replacement enzyme helps to break down the Gb3 and stops it building up in the cells. 
Zamjenski enzim pomaže pri razgradnji Gb3 i zaustavlja njegovu ugradnju u stanice.
Enzyme replacement therapy provides patients with the enzyme they are lacking. 
Enzimska zamjenska terapija osigurava bolesniku enzime koji mu nedostaju.
Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease. 
Replagal je dizajniran kako bi zamijenio ljudski enzim alfa-galaktozidaza A, koji nedostaje osobama s Fabryjevom bolesti.
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal. 
Samo liječnici koji su iskusni u liječenju bolesnika s Fabryjevom bolesti ili drugom nasljednom metaboličkom bolesti smiju primjenjivati lijek Replagal.
The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je odlučio da koristi od lijeka Replagal nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
What is the risk associated with Replagal? 
Koji su rizici povezani s lijekom Replagal?
Replagal is medicine that contains the active substance agalsidase alfa. 
Replagal je lijek koji sadrži djelatnu tvar agalzidaza alfa.
The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits. 
CHMP je odlučio da bolesnici s Fabryevom bolesti mogu imati dugoročne koristi od terapije lijekom Replagal.
Replagal is used to treat patients who have Fabry disease, a rare inherited disorder. 
Replagal se koristi uza liječenje bolesnika s Fabryjevom bolesti, rijetkim nasljednim poremećajem.
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses. 
Replagal je smanjio masu lijevog ventrikula prosječno za 11,5 g dok su bolesnici koji su primali placebo imali povećanje u masi lijevog ventrikula od 21,8 g.
Replagal is an enzyme replacement therapy. 
Replagal je enzimska zamjenska terapija.
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3). 
Ovaj enzim normalno razgrađuje masnu tvar naziva globotriaosilkeramid (Gb3 ili GL-3).
What benefit has Replagal shown during the studies? 
Koje su koristi lijeka Replagal utvrđene u ispitivanjima?
What is Replagal used for? 
Za što se Replagal koristi?
For the full list of all side effects and restrictions with Replagal, see the package leaflet. 
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Replagal potražite u uputi o lijeku.