natgillin/translations-raw huggingface dataset:
Elevate the administration container (if intravenous bag, hang on an intravenous pole). 
Podignite spremnik za primjenu (ako je riječ o vrećici za infuziju, objesite je na stalak za infuziju).
Human alpha1-proteinase inhibitor is a normal constituent of human blood. 
Ljudski inhibitor alfa1-proteinaze je uobičajena sastavnica ljudske krvi.
First infusions should be administered under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency. 
Prve infuzije trebaju biti primijenjene pod nadzorom zdravstvenog radnika s iskustvom u liječenju nedostatka inhibitora alfa1-proteinaze.
CSL Behring LLC Route 50 North 1201 N. Kinzie Bradley, IL 60915 
CSL Behring LLC Route 50 North 1201 N.
Figure 1: Changes in Lung Density (TLC) from baseline in the RAPID and RAPID Extension studies 
Slika 1: Promjene gustoće plućnog tkiva (TLC) od početnih vrijednosti tijekom RAPID ispitivanja i nastavka RAPID ispitivanja
Prime the chamber by squeezing the drip chamber until Respreeza has filled the chamber half-way. 
Punite komoricu stiskanjem komorice s kapaljkom sve dok se komorica dopola ne napuni Respreezom.
There are no data concerning the effect on fertility but as alpha1-proteinase inhibitor is a normal component of human blood, no adverse effects on fertility are expected if you use Respreeza at the recommended dose. 
Nema podataka o utjecaju na plodnost, ali budući da je inhibitor alfa1-proteinaze uobičajena sastavnica ljudske krvi, ne očekuju se štetni učinci na plodnost koristite Respreezu u preporučenim dozama.
Such side effects may occur even if you previously received human alpha1-proteinase inhibitors and had tolerated them well. 
Takve se nuspojave mogu javiti čak i ako ste prethodno primali ljudske inhibitore alfa1-proteinaze i dobro ih podnosili.
This analysis revealed an inverse linear relationship between trough serum alpha1-proteinase inhibitor levels and the annual decline in lung density as measured by volume adjusted CT scans for subjects receiving 60 mg / kg bw intravenous dose of Respreeza. 
Ova analiza pokazala je inverznu linearnu povezanost između najnižih serumskih razina inhibitora alfa1-proteinaze i godišnjeg smanjenja gustoće plućnog tkiva (izmjereno CT-om i standardizirano po volumenu) u ispitanika koji su primali intravensku dozu od 60 mg/kg TT Respreeze.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. 
Unatoč tome, pri primjeni lijekova pripravljenih od ljudske krvi ili plazme, mogućnost prijenosa uzročnika infekcija ne može se posve isključiti.
Respreeza contains approximately 1.9 mg (<1 mmol) sodium per ml of reconstituted solution. 
Respreeza sadrži približno 1,9 mg (<1 mmol) natrija po ml rekonstituirane otopine.
This infusion rate may be adjusted, based upon patient tolerability. 
Brzina infuzije se može prilagoditi, ovisno o tome kako ju bolesnik podnosi.
Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg powder and solvent for solution for infusion 
Respreeza 1,000 mg prašak i otapalo za otopinu za infuziju Respreeza 4,000 mg prašak i otapalo za otopinu za infuziju Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju
The mean trough serum alpha1-proteinase inhibitor levels at steady state (Weeks 7-11) were maintained above 11 M. 
Srednja vrijednost najnižih serumskih razna inhibitora alfa1-proteinaze u ravnotežnom stanju (7.-11. tjedan) zadržala se iznad 11 M.
Take the Mix2Vial set together with the blister package and vertically pierce the water for injections vial with the blue tip of the Mix2Vial set (Figure 2). 
Uzmite Mix2Vial set zajedno s blister pakiranjem i okomito probijte čep bočice s vodom za injekcije plavim vrhom Mix2Vial seta (Slika 2).
The reconstituted solution should be infused intravenously using a separate dedicated infusion line at an infusion rate of about 0.08 ml / kg bw/ min. 
Rekonstituirana otopina treba se infundirati intravenski uz pomoć infuzijskog sustava samo za tu namjenu, brzinom infuzije od otprilike 0,08 ml/kg TT/min.
Frequency of Adverse Reactions (ARs) in clinical studies and post-marketing experience with Respreeza 
Učestalost nuspojava u kliničkim ispitivanjima i razdoblju nakon stavljanja Respreeze u promet
• if you have been found to have a deficiency of certain blood proteins called immunoglobulin type A (IgA) and have developed antibodies against them. 
• ako Vam je pronađen nedostatak određenih proteina koji se nazivaju imunoglobulini tipa
Hypersensitivity reactions may occur, including in patients who have tolerated previous treatment with human alpha1-proteinase inhibitor. 
Reakcije preosjetljivosti se mogu pojaviti i u bolesnika koji su prethodno dobro podnosili liječenje ljudskim inhibitorom alfa1-proteinaze.
This medicine contains the active substance human alpha1-proteinase inhibitor, which is a normal component of the blood and is found in the lung. 
Ovaj lijek sadrži djelatnu tvar ljudski inhibitor alfa1-proteinaze koji je uobičajena sastavnica krvi, a nalazi se i u plućima.
• 1°solvent vial of 95 ml water for injections 
• 1 bočicu otapala s 95 ml vode za injekcije
The total protein content is approximately 4,400 mg per vial. 
Ukupan sadržaj proteina je približno 4,400 mg po bočici.
The active substance is alpha1-proteinase inhibitor. 
Djelatna tvar je inhibitor alfa1-proteinaze.
• 1°solvent vial of 76 ml water for injections 
• 1 bočicu otapala s 76 ml vode za injekcije
Wipe the rubber stopper of the Respreeza vial with antiseptic solution and allow it to dry. 
Obrišite gumeni čep Respreeza bočice antiseptičkom otopinom i pustite da se osuši.
The recommended dose of 60 mg per kg of body weight will take approximately 15 minutes to infuse. 
Za primjenu infuzije preporučene doze od 60 mg po kg tjelesne težine treba otprilike 15 minuta.
Posology The recommended dose of Respreeza is 60 mg / kg body weight (bw) administered once weekly. 
Doziranje Preporučena doza Respreeze je 60 mg/kg tjelesne težine (TT) primijenjeno jednom tjedno.
Place the Respreeza vial on an even and firm surface. 
9. Stavite Respreeza bočicu na ravnu i čvrstu površinu.
How to store Respreeza 6. 
3. Kako primjenjivati Respreezu 4. Moguće nuspojave
Solvent for Respreeza 
Otapalo za Respreezu
The recommended dose of 60 mg / kg bw will take approximately 15 minutes to infuse. 
Za infundiranje preporučene doze od 60 mg/kg TT treba otprilike 15 minuta.
The total protein content is approximately 1,100 mg per vial. 
Ukupan sadržaj proteina je približno 1,100 mg po bočici.
The administration of Respreeza increases and maintains serum levels and lung epithelial lining fluid (ELF) levels of alpha1-proteinase inhibitor leading to a slowdown of the progression of emphysema. 
Primjenom Respreeze podiže se i održava razina inhibitora alfa1-proteinaze u serumu i tekućini koja oblaže epitel (ELF, engl. epithelial lining fluid) što dovodi do usporavanja progresije emfizema.
• The reconstituted solution should be clear, colorless to slightly yellow, and free from visible particles. 
• Rekonstituirana otopina treba biti bistra, bezbojna do blago žuta i bez vidljivih čestica.
This medicine contains 1.9mg sodium perml of reconstituted solution. 
Ovaj lijek sadrži približno 1,9 mg natrija po ml rekonstituirane otopine.
Epithelial lining fluid measurements (ELF) of alpha1-proteinase inhibitor levels showed a consistent increase following treatment. 
Mjerenja razina inhibitora alfa1-proteinaze u tekućini koja oblaže epitel (ELF) pokazala su odgovarajuć porast nakon liječenja.
Altered sense of touch like burning, tingling or feeling of numbness in your hands, arms, legs, or feet (paraesthesia), flushing, hives (urticaria), scaly rash and rash all over the body, physical weakness (asthenia), infusion-site reactions (such as burning, stinging, pain, swelling or redness at the infusion site (hematoma)). 
Manje često (mogu se javiti u do 1 na 100 osoba) Promijenjen osjet dodira kao osjećaj pečenja, žarenja ili utrnulosti u šakama, rukama, nogama ili stopalima (parestezija), crvenilo, koprivnjača (urtikarija), ljuskasti osip te osip po cijelom tijelu, fizička slabost (astenija), reakcije na mjestu primjene (kao što su pečenje, bodenje, bol, oticanje ili crvenilo na mjestu davanja infuzije (hematom)).
Since alpha1-proteinase inhibitor is an endogenous human protein, it is considered unlikely that Respreeza will cause harm to the foetus when given at recommended doses. 
Budući da je inhibitor alfa1-proteinaze endogeni ljudski protein smatra se da nije vjerojatno da će Respreeza naškoditi fetusu ako se daje u preporučenim dozama.
Attach the administration set to the administration container. 
Pričvrstite set za primjenu na spremnik za primjenu.
Excipients : Sodium chloride, sodium dihydrogen phosphate monohydrate, mannitol. 
Pomoćne tvari: natrijev klorid, natrijev dihidrogenfosfat hidrat, manitol.
Presentations 
Opis
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany 
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Njemačka
ELF levels of antigenic alpha1-proteinase inhibitor and alpha1-proteinase inhibitor: NE complexes increased from baseline. 
Razine antigenog inhibitora alfa1-proteinaze i inhibitora alfa1-proteinaze u ELF: Kompleksi s NE bili su brojniji nego na početku.
Since alpha1-proteinase inhibitor is a normal component of human blood, recommended dose of this medicine is not expected to cause harm to the developing foetus. 
Budući da je inhibitor alfa1-proteinaze uobičajena sastavnica ljudske krvi, ne očekuje se da bi preporučena doza ovog lijeka mogla naštetiti razvoju fetusa.
What Respreeza is used for 
Za što se Respreeza koristi
CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany 
CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Njemačka
• 1°solvent vial of 20 ml water for injections 
• 1 bočicu otapala s 20 ml vode za injekcije
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance 
Naziv i adresa proizvođača biološke djelatne tvari
Using this medicine regularly increases the blood and lung levels of alpha1-proteinase inhibitor, thus slowing the progression of emphysema. 
Redovita primjena ovog lijeka podiže razinu inhibitora alfa1-proteinaze u krvi i plućima te tako usporava razvoj emfizema.
Uncommon (≥1/1,000 to 
Manje često (≥1/1000 i <1/100)
Solvent: Water for injections 
Otapalo: Voda za injekcije
Since human alpha1-proteinase inhibitor is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses. 
Budući da je ljudski inhibitor alfa1-proteinaze endogeni ljudski protein, ne očekuju se štetni učinci na plodnost ako se daje u preporučenim dozama.
Human alpha1-proteinase inhibitor 
Ljudski inhibitor alfa1-proteinaze
Sodium dihydrogen phosphate monohydrate Mannitol 
Prašak: natrijev klorid natrijev dihidrogenfosfat hidrat manitol
Invert the water for injections vial with the Mix2Vial set attached and vertically pierce the Respreeza vial with the clear tip of the Mix2Vial set (Figure 4). 
Preokrenite bočicu s vodom za injekcije i pričvršćenim Mix2Vial setom, te okomito probijte čep Respreeza bočice prozirnim vrhom Mix2Vial seta (Slika 4).
How to store Respreeza 
Kako primjenjivati Respreezu
Powder and solvent for solution for infusion. 
Prašak i otapalo za otopinu za infuziju.
The solution should be clear, colourless to slightly yellow, and free from visible particles. 
Otopina treba biti bistra, bezbojna do blago žuta i bez vidljivih čestica.
Respreeza contains sodium 
Respreeza sadrži natrij
A total of 180 subjects with alpha1-proteinase inhibitor deficiency characterized by a serum alpha1-proteinase inhibitor level < 11 μM (i.e. < 50 mg/dL as determined by nephelometry) and clinical evidence of emphysema, were randomized to receive a weekly 60 mg / kg bw intravenous dose of either Respreeza (93 subjects) or placebo (87 subjects) for up to 24 months. 
< 50 mg/dl određeno nefelometrijom) i kliničkim dokazima emfizema bilo randomizirano kako bi primali tjednu intravensku dozu od 60 mg/kg TT Respreeze (93 ispitanika) ili placebo (87 ispitanika) tijekom najviše 24 mjeseca.
During the first infusions, patient's clinical state, including vital signs, should be closely monitored throughout the infusion period. 
Treba se pridržavati brzine infuzije preporučene u dijelu 4.2. Pri prvim infuzijama potrebno je pažljivo nadzirati kliničko stanje bolesnika tijekom davanja infuzije, uključujući vitalne znakove.
• 1°single-use powder vial 
• 1 bočicu s praškom za jednokratnu uporabu
There are limited data regarding the use of this medicinal product in home-treatment / selfadministration. 
Podaci o liječenju kod kuće/samoprimjeni ovog lijeka su ograničeni.
Respreeza 1,000 mg powder and solvent for solution for infusion 3 years 
Respreeza 1,000 mg prašak i otapalo za otopinu za infuziju 3 godine
After reconstitution with 95 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor. 
Nakon rekonstitucije s 95 ml otapala, otopina sadrži približno 50 mg/ml ljudskog inhibitora alfa1-proteinaze.
After reconstitution with 76 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor. 
Nakon rekonstitucije s 76 ml otapala, otopina sadrži približno 50 mg/ml ljudskog inhibitora alfa1-proteinaze.
Human alpha1-proteinase inhibitor 5,000 mg 
Ljudski inhibitor alfa1-proteinaze 5,000 mg
Tell your doctor or healthcare professional immediately if you notice any sign of allergic reactions (for example chills, flushing, faster heartbeat, fall in blood pressure, light-headedness, rash, hives, itching, difficulty in breathing or swallowing as well as swelling of your hands, 
Ako tijekom primjene Respreeze primijetite bilo koji znak alergijskih reakcija (na primjer zimicu, crvenilo, brže kucanje srca, pad krvnog tlaka, ošamućenost, osip, koprivnjaču, svrbež, otežano disanje ili gutanje, kao i oticanje šaka, lica ili usta) odmah recite to svome liječniku ili zdravstvenom radniku.
• Inspect the reconstituted solution for particulate matter and discoloration prior to administration. 
• Prije primjene provjerite rekonstituiranu otopinu na prisutnost čestica i promjenu boje.
If you use more Respreeza than you should 
Ako primijenite više Respreeze nego što ste trebali Posljedice predoziranja nisu poznate.
Respreeza 5,000 mg powder and solvent for solution for infusion 2 years 
Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju 2 godine
Four clinical studies were conducted with Respreeza in 89 subjects (59 males and 30 females) to evaluate the effect of Respreeza on serum levels of alpha1-proteinase inhibitor. 
Kako bi se procijenio utjecaj Respreeze na serumske razine inhibitora alfa1-proteinaze provedena su 4 ispitivanja Respreeze u 89 ispitanika (59 muškaraca i 30 žena).
Respreeza 5,000 mg powder and solvent for solution for infusion One vial contains approximately 5,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase. 
Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju Jedna bočica sadrži približno 5,000 mg ljudskog inhibitora alfa1-proteinaze*, određeno prema njegovom kapacitetu neutraliziranja ljudske neutrofilne elastaze
Human alpha1-proteinase inhibitor 4,000 mg 
Ljudski inhibitor alfa1-proteinaze 4,000 mg
Respreeza 1,000 mg powder and solvent for solution for infusion Respreeza 1,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 
Respreeza 1,000 mg prašak i otapalo za otopinu za infuziju 1,000 mg Respreeza praška u staklenoj bočici (staklo tip I) zatvorenoj gumenim (bromobutil ili klorobutil) čepom i aluminijskim prstenom s plastičnom flip-off kapicom.
Respreeza 4,000 mg powder and solvent for solution for infusion One vial contains approximately 4,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase. 
Respreeza 4,000 mg prašak i otapalo za otopinu za infuziju Jedna bočica sadrži približno 4,000 mg ljudskog inhibitora alfa1-proteinaze*, određeno prema njegovom kapacitetu neutraliziranja ljudske neutrofilne elastaze
After reconstitution with 20 ml solvent, the solution contains approximately 50 mg/ml of human alpha1-proteinase inhibitor. 
Nakon rekonstitucije s 20 ml otapala, otopina sadrži približno 50 mg/ml ljudskog inhibitora alfa1-proteinaze.
Respreeza 1,000 mg powder and solvent for solution for infusion One vial contains approximately 1,000 mg of human alpha1-proteinase inhibitor*, as determined by its capacity to neutralize human neutrophil elastase. 
Respreeza 1,000 mg prašak i otapalo za otopinu za infuziju Jedna bočica sadrži približno 1,000 mg ljudskog inhibitora alfa1-proteinaze*, određeno prema njegovom kapacitetu neutraliziranja ljudske neutrofilne elastaze
The solvent is a clear and colourless solution. 
Otapalo je bistra i bezbojna tekućina.
Respreeza 5,000 mg powder and solvent for solution for infusion Respreeza 5,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 
Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju 5,000 mg Respreeza praška u staklenoj bočici (staklo tip I) zatvorenoj gumenim (bromobutil ili klorobutil) čepom i aluminijskim prstenom s plastičnom flip-off kapicom.
Human alpha1-proteinase inhibitor 1,000 mg 
Ljudski inhibitor alfa1-proteinaze 1000 mg
Dizziness may occur after the administration of this medicine. 
Prijavljivanjem nuspojava možete pridonijeti uprocjeni sigurnosti ovog lijeka.
Nausea 
Poremećaji
Tel: +385 1 5588297 
Marti Farm d.o.o. Tel: +385 1 5588297
95 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 
95 ml vode za injekcije u staklenoj bočici (staklo tip I) zatvorenoj gumenim (klorobutil) čepom i aluminijskim prstenom s plastičnom flip-off kapicom.
76 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 
76 ml vode za injekcije u staklenoj bočici (staklo tip I) zatvorenoj gumenim (klorobutil) čepom i aluminijskim prstenom s plastičnom flip-off kapicom.
A healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency will supervise the first infusions. 
Prve infuzije će nadgledati zdravstveni radnik iskusan u liječenju nedostatka inhibitora alfa1-proteinaze.
- If you get any side effects, talk to your doctor or healthcare professional. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili zdravstvenog radnika.
Respreeza 5,000 mg powder and solvent for solution for infusion. 
Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju.
Nervous system disorders 
Hipoestezija živčanog sustava glavobolja
20 ml of water for injections in a glass vial (type I), closed with a rubber (chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 
20 ml vode za injekcije u staklenoj bočici (staklo tip I) zatvorenoj gumenim (klorobutil) čepom i aluminijskim prstenom s plastičnom flip-off kapicom.
1 solvent vial of 95 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution 
1 bočica s praškom za jednokratnu uporabu 1 bočica otapala s 95 ml vode za injekcije 1 set za prijenos 20/20 (Mix2Vial set) za rekonstituciju
Respreeza 1,000 mg powder and solvent for solution for infusion. 
Respreeza 1,000 mg prašak i otapalo za otopinu za infuziju.
Respreeza 4,000 mg powder and solvent for solution for infusion. 
Respreeza 4,000 mg prašak i otapalo za otopinu za infuziju.
1 solvent vial of 76 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution 
1 bočica s praškom za jednokratnu uporabu 1 bočica otapala s 76 ml vode za injekcije 1 set za prijenos 20/20 (Mix2Vial set) za rekonstituciju
Respreeza 4,000 mg powder and solvent for solution for infusion Respreeza 4,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with a plastic flip off cap. 
4,000 mg Respreeza praška u staklenoj bočici (staklo tip I) zatvorenoj gumenim (bromobutil ili klorobutil) čepom i aluminijskim prstenom s plastičnom flip-off kapicom.
1 solvent vial of 20 ml water for injections 1 transfer set 20/20 (Mix2Vial set) for reconstitution 
1 bočica s praškom za jednokratnu uporabu 1 bočica otapala s 20 ml vode za injekcije 1 set za prijenos 20/20 (Mix2Vial set) za rekonstituciju
Reporting of side effects If you get any side effects, talk to your doctor or healthcare professional. 
Ako primijetite takve reakcije tijekom infuzije ovog lijeka odmah se obratite svom liječniku ili zdravstvenom radniku.
Lymph node pain 
Bol u limfnom čvoru
Respreeza 5,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor 
Respreeza 5,000 mg prašak za otopinu za infuziju Ljudski inhibitor alfa1-proteinaze
Respreeza 4,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor 
Respreeza 4,000 mg prašak za otopinu za infuziju Ljudski inhibitor alfa1-proteinaze
Respreeza 5,000 mg powder and solvent for solution for infusion: 
Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju
Respreeza 5,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor 
Respreeza 5,000 mg prašak i otapalo za otopinu za infuziju Ljudski inhibitor alfa1-proteinaze
Total clearance 
Prijavljivanje nuspojava
Respreeza 1,000 mg powder and solvent for solution for infusion: 
Respreeza 1,000 mg prašak i otapalo za otopinu za infuziju
Respreeza 1,000 mg powder for solution for infusion Human alpha1-proteinase inhibitor 
Respreeza 1000 mg prašak za otopinu za infuziju ljudski inhibitor alfa1-proteinaze
Respreeza 4,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor 
Respreeza 4,000 mg prašak i otapalo za otopinu za infuziju Ljudski inhibitor alfa1-proteinaze
Respreeza 4,000 mg powder and solvent for solution for infusion: 
Respreeza 4,000 mg prašak i otapalo za otopinu za infuziju
Respreeza 1,000 mg powder and solvent for solution for infusion Human alpha1-proteinase inhibitor 
Respreeza 1000 mg prašak i otapalo za otopinu za infuziju Ljudski inhibitor alfa1-proteinaze
Current available data are described in section 5.1. 
Trenutno dostupni podaci opisani su u dijelu 5.1.
The potential risk to humans is unknown. 
Nije poznat potencijalni rizik za ljude.
o The remaining powder may be used within 24 hours for the next dose. 
o Preostali prašak može se iskoristiti unutar 24 sata za iduću dozu.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 
Pažljivo pročitajte cijelu uputu prije nego što počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
Appropriate symptomatic treatment should be provided. 
Potrebno je osigurati prikladno simptomatsko liječenje.
Renvela should be taken with food and not on an empty stomach. 
Renvela se treba uzimati s hranom, a ne na prazan želudac.
Your doctor will advise you if you are taking these medicines. 
Liječnik će Vam dati savjet ako uzimate te lijekove.
In general, the safety profile for children and adolescents (6 to 18 years of age) is similar to the safety profile for adults. 
Općenito, sigurnosni profil za djecu i adolescente (u dobi od 6 do 18 godina) sličan je sigurnosnom profilu odraslih.
If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. 
Ako ste propustili jednu dozu, tu je dozu potrebno preskočiti, a sljedeću dozu treba uzeti u uobičajeno vrijeme uz obrok.
>0.75 to <1.2 
>0,75 do <1,2
Date of first authorisation: 10 June 2009 Date of latest renewal: 20 February 2019 
Datum posljednje obnove odobrenja: 20. veljače 2019.
If the therapy is initiated, patients suffering from these disorders should be monitored. 
Ako je terapija započeta, bolesnike koji boluju od tih poremećaja treba nadzirati.