natgillin/translations-raw huggingface dataset:
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (−22.2/−17.2 mmHg with 40 mg/5 mg; −22.5/−19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (−21.0/−17.6 mmHg) and associated with significant lower oedema rates (1.4% with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg). 
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/17,2 mmHg s 40 mg/5 mg; -22,5/-19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižim stopama edema (1,4% uz 40 mg/5 mg; 0,5% uz 80mg/5 mg; 17,6% uz amlodipin 10 mg).
Anaemia Thrombocytopenia, eosinophilia 
Trombocitopenija, eozinofilija
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/5 mg 
BLISTER SA 7 TABLETA - 40 mg/5 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 40 mg/10 mg 
BLISTER SA 7 TABLETA - 40 mg/10 mg
Hepatic impairment 
Teška hipotenzija
Package leaflet: Information for the user Onduarp 40 mg/10 mg tablets Telmisartan/Amlodipine 
Uputa o lijeku: Informacija za korisnika Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
Batch 
Tahikardija
Package leaflet: Information for the user Onduarp 40 mg/5 mg tablets Telmisartan/Amlodipine 
Uputa o lijeku: Informacija za korisnika Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
What Onduarp looks like and contents of the pack Onduarp 40 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side. 
Onduarp 40 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na drugoj strani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/10 mg 
UNUTARNJA KUTIJA VIŠESTRUKOG PAKOVANJA OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/10 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/5 mg 
BLISTER SA 7 TABLETA - 80 mg/5 mg
The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements. 
Glavni rizični faktori za hiperkalijemiju koje je potrebno razmotriti su: - Dijabetes melitus, oštećenje bubrega, dob (>70 godina).
Renal impairment including acute renal failure General disorders and administration site conditions Rare: 
Opći poremećaji i reakcije na mjestu primjene Rijetko:
Package leaflet: Information for the user Onduarp 80 mg/10 mg tablets Telmisartan/Amlodipine 
Uputa o lijeku: Informacija za korisnika Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg/5 mg 
UNUTARNJA KUTIJA VIŠESTRUKOG PAKOVANJA OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - BEZ PLAVOG OKVIRA - 80 mg/5 mg
Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate). 
Svaka tableta sadržava 40 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate). 
Svaka tableta sadržava 80 mg telmisartana i 5 mg amlodipina (u obliku amlodipinbesilata).
Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate). 
Svaka tableta sadržava 80 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as besylate). 
Svaka tableta sadržava 40 mg telmisartana i 10 mg amlodipina (u obliku amlodipinbesilata).
Package leaflet: Information for the user Onduarp 80 mg/5 mg tablets Telmisartan/Amlodipine 
Uputa o lijeku: Informacija za korisnika Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
MARKETING AUTHORISATION NUMBERS EU/1/11/729/001 (28 tablets) 
EU/1/11/729/001 (28 tableta)
What Onduarp looks like and contents of the pack Onduarp 80 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side. 
Onduarp 80 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na drugoj strani.
What Onduarp looks like and contents of the pack Onduarp 80 mg/5 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side. 
Onduarp 80 mg/5 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na drugoj strani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/10 mg 
VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKOVANJU OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/10 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets - 80 mg/10 mg 
BLISTER SA 7 TABLETA - 80 mg/10 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg/5 mg 
VANJSKA NALJEPNICA NA VIŠESTRUKOM PAKOVANJU OD 360 (4 PAKOVANJA S 90 x 1 TABLETOM) - UKLJUČUJUĆI PLAVI OKVIR - 80 mg/5 mg
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets telmisartan/amlodipine 
Onduarp 40 mg/10 mg tablete telmisartan/amlodipin
Blue and white oval shaped two layer tablets engraved with the product code A1 and the company logo on the other side. 
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A1 i logom tvrtke na drugoj strani.
What Onduarp looks like and contents of the pack Onduarp 40 mg/10 mg tablets are blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side. 
Onduarp 40 mg/10 mg tablete su dvoslojne, plavo-bijele tablete ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na drugoj strani.
MARKETING AUTHORISATION NUMBERS EU/1/11/729/002 (28 tablets) 
EU/1/11/729/002 (28 tableta)
Respiratory, thoracic and mediastinal disorders cough 
Poremećaji dišnog sustava, prsišta i sredoprsja kašalj
NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets telmisartan/amlodipine 
Onduarp 40 mg/5 mg tablete telmisartan/amlodipin
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets) 
EU/1/11/729/004 (360 (4 x 90 x 1) tableta)
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/006 (360 (4 x 90 x 1) tablets) 
EU/1/11/729/006 (360 (4 x 90 x 1) tableta)
Blue and white oval shaped two layer tablets engraved with the product code A4 and the company logo on the other side. 
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A4 i logom tvrtke na drugoj strani.
Blue and white oval shaped two layer tablets engraved with the product code A3 and the company logo on the other side. 
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A3 i logom tvrtke na drugoj strani.
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets telmisartan/amlodipine 
Onduarp 80 mg/10 mg tablete telmisartan/amlodipin
NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets telmisartan/amlodipine 
Onduarp 80 mg/5 mg tablete telmisartan/amlodipin
Blue and white oval shaped two layer tablets engraved with the product code A2 and the company logo on the other side. 
Dvoslojna plavo-bijela tableta ovalnog oblika, s utisnutom oznakom proizvoda A2 i logom tvrtke na drugoj strani.
Micturition disorder, pollakiuria Reproductive system and breast disorders Uncommon: 
Tahikardija Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
Check with your doctor or pharmacist if you are not sure. 
Ako niste sigurni, posavjetujte se s liječnikom ili ljekarnikom.
MARKETING AUTHORISATION HOLDER 
ODOBRENJA ZA STAVLJANJE GOTOVOG lIJEKA U PROMET
MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/005 (28 tablets) 
EU/1/11/729/005 (28 tableta)
Hepatic function abnormal, liver disorder2 Skin and subcutaneous tissue disorders Uncommon: Rare: 
Angioedem (s fatalnim ishodom), medikamentni osip, toksične erupcije na koži, urtikarija Poremećaji mišićno-koštanog sustava i vezivnog tkiva Rijetko:
Vascular disorders Very rare: 
Poremaćaji srca Vrlo rijetko:
What is Raligize? 
Što je Raligize?
On 10 July 2018, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raligize, for the treatment of cancer of the cervix (the neck of the womb). 
Dana 10. srpnja 2018. tvrtka FGK Representative Service GmbH službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Raligize za liječenje karcinoma cerviksa (vrata maternice).
As the CAT was still evaluating the initial documentation provided by the company on behalf of the CHMP, it had not yet made any recommendations. 
Budući da je CAT još procjenjivao inicijalnu dokumentaciju koju je dostavila tvrtka u ime CHMP-a, CHMP još uvijek nije donio nikakve preporuke.
It was to be available as a concentrate for making up an infusion (drip) to be given into a vein. 
Trebao je biti dostupan kao koncentrat od kojeg se priprema infuzija (kapanje) u venu.
The application was withdrawn while the CAT was still evaluating the initial documentation provided by the company. 
Zahtjev je povučen u trenutku kada je CAT još procjenjivao inicijalnu dokumentaciju koju je tvrtka dostavila.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Raligize. 
Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se primjenjuje lijek Raligize.
EMA/499771/2018 
(aksalimogen filolisbak) EMA/499771/2018
Raligize was developed as a type of advanced therapy medicine called a ‘gene therapy product'. 
Raligize je razvijen kao vrsta lijeka za naprednu terapiju koji se naziva „lijek za gensku terapiju”.
The company provided data from one main study involving 50 women with advanced cervical cancer, including cancer that had come back after other treatment or had spread elsewhere in the body. 
Tvrtka je dostavila podatke iz jednog glavnog ispitivanja u kojem je sudjelovalo 50 žena s uznapredovalim karcinomom cerviksa, uključujući karcinom koji se vratio nakon drugog liječenja ili se proširio na drugi dio organizma.
Results of treatment with Raligize were compared with results previously seen in similar women given other treatments for cervical cancer. 
Rezultati liječenja lijekom Raligize uspoređeni su s prethodno opaženim rezultatima u sličnih žena u kojih su primijenjena druga liječenja za karcinom cerviksa.
Because Raligize is an advanced therapy medicine, it was assessed on behalf of the CHMP by the Committee for Advanced Therapies (CAT). 
Budući da je Raligize lijek za naprednu terapiju, u ime CHMP-a procijenio ga je Odbor za napredne terapije (engl.
Raligize was to be used to treat women with cervical cancer whose disease had not responded to, or had come back after, initial treatment. 
Raligize se trebao upotrebljavati za liječenje žena s karcinomom cerviksa koje nisu odgovorile na početno liječenje ili se karcinom vratio nakon početnog liječenja.
How does Raligize work? 
Kako djeluje Raligize?
What was Raligize expected to be used for? 
Za što se Raligize trebao koristiti?
Raligize is a cancer medicine containing the active substance axalimogene filolisbac. 
Raligize je lijek koji sadržava djelatnu tvar aksalimogen filolisbak.
Cervical cancer is mainly caused by long-lasting infection with certain strains of the human papillomavirus (HPV), which produce proteins in infected cells that stimulate them to grow and become cancerous. 
Karcinom cerviksa uglavnom je prouzročen dugotrajnom infekcijom određenim sojevima humanog papiloma virusa (HPV), koji proizvodi proteine u zaraženim stanicama koji stanice potiču da rastu i postanu kancerozne.
In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to initial concerns expressed by the CAT that the data from the main study would not be sufficient to support the approval of the medicine. 
U svojem dopisu u kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da zahtjev povlači zbog početnih zabrinutosti koje je izrazio Odbor za napredne terapije u pogledu podataka iz glavnog ispitivanja.
The active substance in Raligize, axalimogene filolisbac, consists of a bacterium, Listeria monocytogenes, that has been modified so it can produce a protein that stimulates the immune (defence) system to attack cancer cells. 
Djelatna tvar u lijeku Raligize, aksalimogen filolisbak, sastoji se od bakterije, Listeria monocytogenes, koja je izmijenjena tako da može proizvoditi protein koji potiče imunosni (obrambeni) sustav da napada stanice raka.
When Raligize is given to the patient, the bacteria are taken up by cells of the immune system where they stimulate it to recognize the E7 protein and attack and kill cancer cells that contain it. 
Kad bolesnik primi lijek Raligize, stanice imunosnog sustava preuzimaju bakterije koje ga potiču da prepozna protein E7 te da napadne i ubije stanice raka koje sadržavaju taj protein.
The bacteria in Raligize have had a gene inserted in their DNA so they can produce a new substance containing one of the HPV proteins, E7, linked to part of another protein, listeriolysin O. The linked protein is able to stimulate the immune system against E7. 
U DNK bakterija u lijeku Raligize unesen je gen kako bi proizvodile novu tvar koja sadržava jedan od proteina HPV-a, E7, koji je povezan s dijelom drugog proteina, listeriolizina O.
* Tissue culture infectious dose 50% 
∗ 50 % infektivne doze kulture tkiva
--1 Lyophilisate (live attenuated) Canine distemper virus, strain Bio CDV 11/A 
--1 Liofilizat (živi, atenuirani) Virus štenećaka, soj CDV Bio 11/
Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 
Pseći parvovirus tip 2b, soj CPV-2b-Bio 12/B 104.3 -106.6 TCID50* Pseći parainfluenca virus tip 2, soj CpiV-Bio 15 103.1 -105.1 TCID50*
Lyophlilisate: 1 dose + solvent: 1 ml 
Liofilizat: staklena bočica Otapalo: staklena bočica
moroctocog alfa 
moroktokog alfa
The full EPAR for ReFacto AF can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Cjeloviti EPAR za lijek ReFacto AF nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
In February 2009, a number of changes to the way ReFacto is made were introduced. 
U veljači 2009. uvedene su brojne promjene u postupak proizvodnje lijeka ReFacto.
The European Commission granted a marketing authorisation valid throughout the European Union for ReFacto AF on 13 April 1999. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek ReFacto AF na snazi u Europskoj uniji od 13. travnja 1999.
What measures are being taken to ensure the safe and effective use of ReFacto AF? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka ReFacto AF?
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 ReFacto AF. 
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 i svoje preporuke za uporabu lijeka ReFacto AF.
Uncommonly, patients may also develop allergic reactions. 
Bolesnici rijetko doživljavaju alergijske reakcije.
Following these changes, the company carried out a study to show that ReFacto and ReFacto AF were treated by the body in the same way. 
Nakon tih promjena tvrtka je provela ispitivanje kako bi pokazala da tijelo reagira na lijekove ReFacto i ReFacto AF na isti način.
Patients may also develop antibodies against factor VIII medicines such as Refacto AF. 
Bolesnici također mogu razviti protutijela protiv lijekova za faktor VIII kao što je ReFacto AF.
ReFacto AF can be used in patients of all ages, including newborns. 
Lijek ReFacto AF može se primjenjivati u bolesnika svih dobi, uključujući novorođenčad.
These are known as inhibitors as they can prevent the medicine from working effectively, which may result in a loss of bleeding control. 
Ta su protutijela poznata kao inhibitori koji mogu spriječiti djelovanje lijeka što može dovesti do gubitka kontrole nad krvarenjem.
This is a summary of the European public assessment report (EPAR) for ReFacto AF. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek ReFacto AF.
These included removal of the use of a protein called albumin, which is produced from human blood, from the manufacturing process. 
Te su promjene obuhvaćale uklanjanje uporabe bjelančevine albumin, koja se dobiva iz ljudske krvi, iz postupka proizvodnje.
Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems, such as bleeding in the joints, muscles and internal organs. 
Bolesnici s hemofilijom A nemaju dostatne razine faktora VIII, proteina potrebnog za normalno zgrušavanje krvi, pa stoga lako krvare i mogu imati probleme poput krvarenja u zglobovima, mišićima i unutarnjim organima.
The active substance in ReFacto AF, moroctocog alfa, works in the body in the same way as human factor VIII. 
Djelatna tvar u lijeku ReFacto AF, moroktokog alfa, djeluje u tijelu na isti način kao ljudski faktor VIII.
Other information about ReFacto AF 
Ostale informacije o lijeku ReFacto AF
ReFacto AF is given by injection into a vein over several minutes. 
Lijek ReFacto AF daje se injekcijom u venu u trajanju od nekoliko minuta.
For more information about treatment with ReFacto AF, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o liječenju lijekom ReFacto AF pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
The CHMP noted that ReFacto AF was comparable to ReFacto, the original form of the medicine. 
CHMP je ocijenio da je lijek ReFacto AF usporediv s lijekom ReFacto, izvornim oblikom lijeka.
Full details on how to calculate the dose are included in the summary of product characteristics (also part of the EPAR). 
Potpune informacije o načinu izračunavanja doza sadržane su u sažetku opisa svojstava lijeka (također dio EPAR-a).
The dose and the frequency of treatment depend on whether ReFacto AF is used to treat or prevent bleeding, the seriousness of the condition, the extent and location of the bleeding or the type of surgery, and the patient's bodyweight. 
Doza i učestalost terapije ovise o tome koristi li se lijek ReFacto AF za liječenje ili sprečavanje krvarenja, ozbiljnosti stanja, snazi i mjestu krvarenja ili vrsti operacije te bolesnikovoj tjelesnoj težini.
The name of the medicine was also changed from ReFacto to ReFacto AF. 
Naziv lijeka promijenjen je iz ReFacto u ReFacto AF.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refacto AF have 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 ReFacto AF nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately. 
Bolesnici ili njihovi njegovatelji mogu davati injekcije lijeka ReFacto AF ako su odgovarajuće osposobljeni za to.
ReFacto AF contains the active substance moroctocog alfa. 
ReFacto AF sadrži djelatnu tvar moroktokog alfa.
The most common side effects with ReFacto AF (seen in more than 1 patient in 10) are headache, cough, pain in the joints and fever. 
Najčešće su nuspojave lijeka ReFacto AF (koje se mogu javiti u više od 1 na 10 bolesnika) glavobolja, kašalj, bol u zglobovima i vrućica.
ReFacto AF must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins. 
Lijek ReFacto AF ne smije se koristiti u osoba koje su preosjetljive (alergične) na rekombinantni koagulacijski faktor VIII, na bilo koji drugi sastojak ovog lijeka ili na proteine hrčka.
ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies. 
Lijek ReFacto AF odobren je u travnju 1999. pod nazivom ReFacto za primjenu u prethodno liječenih i neliječenih bolesnika s hemofilijom A na temelju rezultata triju glavnih ispitivanja.
ReFacto AF should be started under the supervision of a doctor who has experience in the treatment of haemophilia A. 
Liječenje lijekom ReFacto AF treba započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije A.
It is available as vials or pre-filled syringes. 
Dostupan je u bočicama ili napunjenim štrcaljkama.
The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A. 
Ispitivanja su pokazala da je lijek ReFacto AF jednako neškodljiv i djelotvoran kao i lijek ReFacto za sprječavanje i liječenje epizoda krvarenja u bolesnika s hemofilijom A.
It also carried out two main studies looking at the effectiveness of ReFacto AF: the first looked at the prevention and treatment of bleeding episodes in 94 previously treated patients and the second looked at the prevention of bleeding in 22 patients having surgery. 
Prvo se ispitivanje odnosilo na sprečavanje i liječenje epizoda krvarenja u 94 prethodno neliječenih bolesnika, dok se drugo odnosilo na sprečavanje krvarenja u 22 kirurška pacijenta.
ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder). 
Lijek ReFacto AF koristi se za liječenje i prevenciju krvarenja bolesnika s hemofilijom A (nasljednim poremećajem krvarenja).
What is the risk associated with ReFacto AF? 
Koji su rizici povezani s lijekom ReFacto AF?
Why has ReFacto AF been approved? 
Zašto je lijek ReFacto AF odobren?
The human coagulation factor VIII in ReFacto AF is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII. 
Ljudski koagulacijski faktor VIII u lijeku ReFacto AF ne ekstrahira se iz ljudske krvi nego se proizvodi metodom poznatom kao „tehnologija rekombinantne DNK”.
Therefore, the Committee decided that the benefits of ReFacto AF are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je odlučio da koristi od lijeka ReFacto AF nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
ReFacto AF is a powder and solvent used to make up a solution for injection. 
Lijek ReFacto AF dostupan je u obliku praška i otapala koji se zajedno miješaju kako bi se dobila otopina za injekciju.
How is ReFacto AF used? 
Kako se ReFacto AF koristi?
What is ReFacto AF used for? 
Za što se ReFacto AF koristi?
What benefit has ReFacto AF shown during the studies? 
Koje su koristi lijeka ReFacto AF utvrđene u ispitivanjima?
What is ReFacto AF? 
Što je ReFacto AF?
For the full list of all side effects reported with ReFacto AF, see the package leaflet. 
Potpuni popis nuspojava zabilježenih pri primjeni lijeka ReFacto AF potražite u uputi o lijeku.
How does ReFacto AF work? 
Kako je ReFacto AF ispitivan?
(Invented) name Strength Pharmaceutical Form 
Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
Route of Administration 
Način uzimanja Unutarnje pakiranje