natgillin/translations-raw huggingface dataset:
Talk to your doctor about the best way to feed your baby if you are taking RXULTI.
Ako uzimate RXULTI, upitajte liječnika koji je najbolji način da hranite svoje dijete.
The incidence of blood prolactin increased was 0.9 % in 2 mg to 4 mg brexpiprazole group compared to that of 0.5 % in placebo in short-term, controlled trials.
U kratkotrajnim kontroliranim ispitivanjima, incidencija povišenog prolaktina u krvi bila je 0,9 % u skupini liječenoj brekspiprazolom u dozi od 2 mg do 4 mg u usporedbi s onom od 0,5 % u skupini koja je primala placebo.
Brexpiprazole steady-state concentrations are attained within 10 days to 12 days of dosing.
10 dana do 12 dana doziranja.
Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* 181 94.99
1 Brekspiprazol (2 mg na dan)* 181 Brekspiprazol
les Bouillides Sophia Antipolis 06560 Valbonne France
Elaiapharm 2881 Route des Crêtes Z.I. les Bouillides Sophia Antipolis 06560 Valbonne Francuska
In the brexpiprazole 12 mg/day group, the maximum placebo-adjusted mean change from baseline in the QTcl interval was 2.9 ms (90 % Cl: −1.2, 6.9) in males (n = 40) at 12 hours post-dosing and 10.4 ms (90 % Cl: 2.7, 18.2) in females (n = 13) at 24 hours post-dosing.
CI: −1,2; 6,9) u muškaraca (n = 40) 12 sati nakon primjene doze te 10,4 ms (90 % CI: 2,7, 18,2) u žena
• Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili obitelj promijenjen ili povećan seksualni interes i ponašanje koje znatno zabrinjava Vas ili druge, na primjer, povećani seksualni poriv
Each film-coated tablet contains 48.2 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 48,2 mg laktoze (u obliku laktoza hidrata).
Musculoskeletal and connective tissue disorders
Krvožilni poremećaji venska tromboembolija
Strong CYP3A4 inhibitors
Jaki inhibitori CYP3A4
Blood creatine phosphokinase increased
povišena kreatin fosfokinaza u krvi povišen krvni tlak povišeni trigliceridi u krvi povišeni jetreni enzimi
Oesophageal dysmotility and aspiration have been associated with antipsychotic use.
S primjenom antipsihotika povezuju se poremećaj motiliteta jednjaka i aspiracija.
Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) were akathisia (5.6 %) and weight gain
Najčešće opažene nuspojave bile su akatizija (5,6 %) i povećanje tjelesne težine (3,9 %).
Seizures
Čimbenici
Mechanism of action
Global Assessment of
Each film-coated tablet contains 1 mg brexpiprazole.
Jedna filmom obložena tableta sadrži 1 mg brekspiprazola.
RXULTI 1 mg film-coated tablets
RXULTI 1 mg filmom obložene tablete
Each film-coated tablet contains 47.9 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 47,9 mg laktoze (u obliku laktoza hidrata).
RXULTI 0.25 mg film-coated tablets
RXULTI 0,25 mg filmom obložene tablete
Each film-coated tablet contains 4 mg brexpiprazole.
Jedna filmom obložena tableta sadrži 4 mg brekspiprazola.
RXULTI 2 mg film-coated tablets
RXULTI 2 mg filmom obložene tablete
RXULTI 0.5 mg film-coated tablets
RXULTI 0,5 mg filmom obložene tablete
Each film-coated tablet contains 2 mg brexpiprazole.
Jedna filmom obložena tableta sadrži 2 mg brekspiprazola.
RXULTI 0.25 mg film-coated tablets Iron oxide E 172 (yellow, red, black)
Željezov oksid E 172 (žuti, crveni, crni)
RXULTI 3 mg film-coated tablets
RXULTI 3 mg filmom obložene tablete
Each film-coated tablet contains 3 mg brexpiprazole.
Jedna filmom obložena tableta sadrži 3 mg brekspiprazola.
(Ki: 0.1 nM to 0.5 nM).
(vidjeti dijelove 4.5 i 5.2).
RXULTI 3 mg film-coated tablets Iron oxide E 172 (red, black)
Željezov oksid E 172 (crveni, crni)
Each film-coated tablet contains 46.4 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 46,4 mg laktoze (u obliku laktoza hidrata).
Titanium dioxide
Tardivna diskinezija
Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side.
Svjetlonarančasta, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 0.5 na jednoj strani.
Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side.
Svjetlosmeđa, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 0.25 na jednoj strani.
RXULTI 4 mg film-coated tablets brexpiprazole
RXULTI 4 mg filmom obložene tablete brekspiprazol
Rhabdomyolysis
• proljev
Difference (brexpiprazole minus placebo) in least-squares mean change from baseline, at week 6
interval pouzdanosti liječenje statistički značajno superiorno placebu a razlika (brekspiprazol minus placebo) u srednjoj vrijednosti promjene od početne vrijednosti dobivenoj metodom najmanjih kvadrata u 6. tjednu b
RXULTI 3 mg film-coated tablets EU/1/18/1294/006 (28 film-coated tablets)
RXULTI 3 mg filmom obložene tablete EU/1/18/1294/006 (28 filmom obloženih tableta)
CYP2D6 poor metabolisers
Spori metabolizatori CYP2D6
RXULTI 1 mg film-coated tablets brexpiprazole
RXULTI 1 mg filmom obložene tablete brekspiprazol
Based on the patient's clinical response and tolerability the brexpiprazole dose can be titrated to 2 mg once daily on day 5 through day 7 and then to 4 mg on day 8.
2 mg jedanput dnevno od 5. do 7. dana i potom na 4 mg 8. dana.
RXULTI 0.5 mg film-coated tablets brexpiprazole
RXULTI 0,5 mg filmom obložene tablete brekspiprazol
RXULTI 4 mg film-coated tablets EU/1/18/1294/007 (28 film-coated tablets)
RXULTI 4 mg filmom obložene tablete EU/1/18/1294/007 (28 filmom obloženih tableta)
Pregnancy
• napadaji
Electrocardiogram QT prolonged
Srčani poremećaji produljenje QT-intervala na elektrokardiogram u
RXULTI 2 mg film-coated tablets Iron oxide E 172 (yellow, black)
Željezov oksid E 172 (žuti, crni)
Each film-coated tablet contains 47.4 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 47,4 mg laktoze (u obliku laktoza hidrata).
• muscle pain,
• bol u mišićima
RXULTI 2 mg film-coated tablets EU/1/18/1294/005 (28 film-coated tablets)
RXULTI 2 mg filmom obložene tablete EU/1/18/1294/005 (28 filmom obloženih tableta)
Myalgia
pvrijednost
RXULTI 0.25 mg film-coated tablets brexpiprazole
RXULTI 0,25 mg filmom obložene tablete brekspiprazol
Each film-coated tablet contains 45.4 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 45,4 mg laktoze (u obliku laktoza hidrata).
Dosing modifications to half the recommended doses is required for patients with known CYP2D6 poor metaboliser status.
U bolesnika za koje je utvrđeno da su spori metabolizatori CYP2D6 potrebno je prilagoditi dozu na pola preporučene doze.
RXULTI 0.5 mg film-coated tablets EU/1/18/1294/002 (28 film-coated tablets)
RXULTI 0,5 mg filmom obložene tablete EU/1/18/1294/002 (28 filmom obloženih tableta)
Light green, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 2 on one side.
Svjetlozelena, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 2 na jednoj strani.
RXULTI 2 mg film-coated tablets brexpiprazole
RXULTI 2 mg filmom obložene tablete brekspiprazol
RXULTI 3 mg film-coated tablets brexpiprazole
RXULTI 3 mg filmom obložene tablete brekspiprazol
RXULTI 0.25 mg film-coated tablets EU/1/18/1294/001 (28 film-coated tablets)
RXULTI 0,25 mg filmom obložene tablete EU/1/18/1294/001 (28 filmom obloženih tableta)
RXULTI 0.5 mg film-coated tablets Iron oxide E 172 (yellow, red)
Željezov oksid E 172 (žuti, crveni)
Each film-coated tablet contains 44.4 mg lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 44,4 mg laktoze (u obliku laktoza hidrata).
Known CYP2D6 poor metabolisers
Utvrđeno spori metabolizatori CYP2D6
• irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring).
• nepravilne otkucaje srca ili je netko drugi u Vašoj obitelji imao nepravilne otkucaje srca
For nausea, the incidence in the 2 mg to 4 mg brexpiprazole group was 2.3 % overall in short-term controlled trials, compared to 2.0 % in placebo; for vomiting, these incidences were 1.0 % in the brexpiprazole-treated group compared to 1.2 % in placebo group.
incidencija povraćanja iznosila je 1,0 % u skupini liječenoj brekspiprazolom u usporedbi s 1,2 % u skupini koja je primala placebo.
Light purple, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 3 on one side.
Svjetloljubičasta, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 3 na jednoj strani.
Light yellow, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 1 on one side.
Svjetložuta, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 1 na jednoj strani.
Co-administration of a 2 mg single oral dose of brexpiprazole with quinidine (324 mg/day for 7 days), a potent inhibitor of CYP2D6, increased the AUC of brexpiprazole by 94 % and no change in Cmax.
7 dana), jakim inhibitorom CYP2D6, povećala je AUC brekspiprazola za 94 %, bez promjene u Cmax.
RXULTI 1 mg film-coated tablets Iron oxide E 172 (yellow)
Željezov oksid E 172 (žuti)
Apparent oral clearance of brexpiprazole tablet after once daily administration is 19.8 (± 11.4) mL/h/kg.
19,8 (± 11,4) ml/h/kg.
Name and address of the manufacturer(s) responsible for batch release
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
Tel: +421 2 5341 42 18
Lundbeck Slovensko s.r.o. Tel: +421 2 5341 42 18
Dental caries Flatulence
Ispitiv anje
How to store RXULTI
Moguće nuspojave Kako čuvati RXULTI
• shaking,
(engl.
Weight gain
ROK VALJANOSTI
Daily dose must not exceed 12 mg when brexpiprazole is used concomitantly with strong CYP3A4 inducers.
Kad se brekspiprazol primjenjuje istodobno s jakim induktorima CYP3A4, dnevna doza ne smije biti viša od 12 mg.
Pregnancy, puerperium and perinatal conditions
Stanja vezana uz trudnoću, babinje i perinatalno razdoblje sindrom ustezanja od lijeka u novorođenčeta
(Invented) name
(Novoizumljen o) ime
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Popis naziva, farmaceutskog oblika, jačina lijekova, puta primjene, nositelja odobrenja u državama članicama
Netherlands Sanofi-Aventis Netherlands B.V.
Nizozemska Sanofi-Aventis Netherlands B.V.
Five main studies were carried out.
Provedeno je pet glavnih ispitivanja.
However, the duration of protection is not known.
Međutim, trajanje zaštite nije poznato.
It is not yet known how long the protection will last.
Još uvijek se ne zna koliko će dugo trajati zaštita.
Imvanex has been authorised under ‘exceptional circumstances'.
Imvanex je odobren pod „iznimnim okolnostima”.
Further information on Imvanex can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imvanex.
Više informacija o cjepivu Imvanex dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/imvanex.
Smallpox was officially declared eradicated in 1980 with the last known case of the disease occurring in 1977.
Velike boginje službeno su proglašene iskorijenjenima 1980. s posljednjim poznatim slučajem bolesti 1977.
The vaccine can only be obtained with a prescription.
Cjepivo se izdaje samo na recept.
Imvanex (live modified vaccinia ankara virus)
Imvanex (živi modificirani virus vakcinije Ankara)
Vaccines work by ‘teaching' the immune system how to defend itself against a disease.
Cjepiva djeluju „učeći” imunosni sustav kako se obraniti od bolesti.
When the person comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Kada je osoba ponovno izložena ovom ili sličnom virusu, ta će protutijela zajedno s drugim dijelovima imunosnog sustava moći uništiti virus i pomoći pri zaštiti od bolesti.
This vaccine will be used when it is considered necessary to protect against smallpox in accordance with official recommendations.
Ovo cjepivo koristit će se u situacijama kad se smatra potrebnim zaštititi stanovništvo od velikih boginja u skladu sa službenim preporukama.
The most common side effects with Imvanex (which may affect more than 1 in 10 people) are headache, nausea, myalgia (muscle pain), tiredness and injection site reactions (pain, redness, swelling, hardening and itching).
Najčešće nuspojave cjepiva Imvanex (koje se mogu javiti u više od 1 na 10 osoba) jesu glavobolja, mučnina, mijalgija (bol u mišićima), umor i reakcije na mjestu primjene (bol, crvenilo, oticanje, otvrdnuće i svrbež).
Vaccines containing vaccinia viruses were effective in the campaign to eradicate smallpox.
Cjepiva koja sadrže viruse vakcinije bila su učinkovita u kampanji iskorjenjivanja velikih boginja.
Imvanex would therefore be beneficial for people who cannot be given vaccines containing replicating viruses, such as patients with a weakened immune system.
Imvanex bi stoga bio koristan za osobe koje ne mogu primiti cjepiva koja sadrže replicirajuće viruse, kao što su bolesnici s oslabljenim imunosnim sustavom.
What is Imvanex and what is it used for?
Što je Imvanex i za što se koristi?
This is because it has not been possible to obtain complete information about Imvanex due to the rarity of the disease.
Razlog tome je nemogućnost dobivanja potpunih informacija o cjepivu Imvanex zbog male učestalosti bolesti.
Since Imvanex has been authorised under exceptional circumstances, the company that markets Imvanex will provide data on the vaccine's benefits and risks from observational studies in patients who are given the vaccine, and if ever there is an outbreak of the disease in the future.
Budući da je cjepivo Imvanex odobreno u iznimnim okolnostima, tvrtka koja stavlja cjepivo Imvanex u promet dostavit će podatke o koristima i rizicima cjepiva iz opservacijskih ispitivanja na bolesnicima koji primaju to cjepivo te u slučaju izbijanja bolesti u budućnosti.
Imvanex must not be used in patients who are hypersensitive (allergic) to the active substance or any of the substances found at trace levels, such as chicken protein, benzonase and gentamicin.
Imvanex se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatnu tvar ili bilo koju tvar prisutnu u tragovima poput pilećih proteina, benzonaza i gentamicina.
When a person is given the vaccine, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Kada osoba primi cjepivo, imunosni sustav prepoznaje virus u cjepivu kao „strano tijelo” i proizvodi protutijela na virus.
Side effects reported with Imvanex are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za cjepivo Imvanex pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
What measures are being taken to ensure the safe and effective use of Imvanex?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena cjepiva Imvanex?
It contains a live modified form of the vaccinia virus called ‘vaccinia Ankara', which is related to the smallpox virus.
Sadrži živi modificirani oblik virusa vakcinije zvan „vakcinija Ankara”, koji je povezan s virusom velikih boginja.
The studies involved over 2,000 adults, including patients with HIV and atopic dermatitis (an itchy skin condition caused by an overactive immune system) and people who had been vaccinated against smallpox in the past.
Ispitivanja su obuhvatila više od 2 000 odraslih osoba, uključujući bolesnike s HIV-om i atopijskim dermatitisom (kožna bolest praćena svrbežom uzrokovana prekomjerno aktivnim imunosnim sustavom) i osobe koje su prethodno primile cjepivo protiv velikih boginja.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imvanex 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 cjepiva Imvanex nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
If a booster dose is necessary for those who have been vaccinated against smallpox in the past, a single 0.5 ml dose should be given except for patients with a weakened immune system (the body's natural defences) who should receive two booster doses, with the second dose given at least 28 days after the first.
Ako je potrebno provesti docjepljivanje osoba koje su u prošlosti cijepljene protiv velikih boginja, potrebno je dati pojedinačnu dozu od 0,5 ml s izuzetkom bolesnika s oslabljenim imunosnim sustavom (prirodna obrana tijela) koji trebaju primiti dvije doze docjepljivanja, pri čemu drugu dozu treba dati najranije 28 dana nakon prve doze.
As for all medicines, data on the use of Imvanex are continuously monitored.
Kao i za sve lijekove, podatci o primjeni cjepiva Imvanex kontinuirano se prate.
Other information about Imvanex
Ostale informacije o cjepivu Imvanex
For more information about using Imvanex, see the package leaflet or contact your doctor or pharmacist.
Za više informacija o primjeni cjepiva Imvanex pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
Imvanex received a marketing authorisation valid throughout the EU on 31 July 2013.
Cjepivo Imvanex dobilo je odobrenje za stavljanje u promet koje je na snazi u EU-u od 31. srpnja
An overview of Imvanex and why it is authorised in the EU
Pregled informacija o cjepivu Imvanex i zašto je odobreno u EU-u
Imvanex contains a modified form of the vaccinia virus called vaccinia Ankara, which does not cause disease in humans and cannot replicate (reproduce) in human cells.
Imvanex sadrži modificirani oblik virusa vakcinije zvan „vakcinija Ankara” koji ne uzrokuje bolest u ljudi i ne može se umnažati u ljudskim stanicama.
What are the risks associated with Imvanex?
Koji su rizici povezani s cjepivom Imvanex?
A subsequent study in 433 people who had not been vaccinated before found that the level of protective antibodies after vaccination with Imvanex was at least as high as with a conventional smallpox vaccine.
U sljedećem ispitivanju na 433 osobe koje prethodno nisu bile cijepljene utvrđeno je da je razina zaštitnih protutijela nakon cijepljenja cjepivom Imvanex bila najmanje jednaka kao kod konvencionalnog cjepiva protiv velikih boginja.
Two of the studies specifically looked at the effectiveness of Imvanex as a booster.
U dvama ispitivanjima posebno se ispitala djelotvornost cjepiva Imvanex u docjepljivanju.
Because of its similarity to the smallpox virus, antibodies produced against this virus are also expected to protect against smallpox.
S obzirom na sličnost s virusom velikih boginja, očekuje se da će protutijela koja se proizvode na ovaj virus također štititi od velikih boginja.
Why is Imvanex authorised in the EU?
Zašto je cjepivo Imvanex odobreno u EU-u?
Imvanex is a vaccine used to protect against smallpox in adults.
Imvanex je cjepivo za zaštitu od velikih boginja u odraslih osoba.
The vaccinia virus in Imvanex cannot replicate in human cells and hence is less likely to cause side effects than conventional smallpox vaccines.
Virus vakcinije u cjepivu Imvanex ne može se umnažati u ljudskim stanicama i stoga je, u usporedbi s konvencionalnim cjepivima protiv velikih boginja, manje vjerojatno da će izazvati nuspojave.
The European Medicines Agency considered that Imvanex is effective at triggering the production of antibodies against smallpox to a level that provides protection at least as high as that from conventional smallpox vaccines.
Europska agencija za lijekove zaključila je da je cjepivo Imvanex djelotvorno u poticanju proizvodnje protutijela za velike boginje do razine kojom se osigurava najmanje jednaka zaštita kao kod konvencionalnog cjepiva protiv velikih boginja.
How does Imvanex work?
Kako djeluje Imvanex?
What information is still awaited for Imvanex?
Koje se još informacije očekuju o cjepivu Imvanex?
Imvanex was shown in studies to be effective at triggering the production of antibodies to a level expected to provide protection against smallpox.
U ispitivanjima je dokazano da je Imvanex djelotvoran u poticanju proizvodnje protutijela do razine pri kojoj se očekuje pružanje zaštite od velikih boginja.
What benefits of Imvanex have been shown in studies?
Koje su koristi od cjepiva Imvanex utvrđene u ispitivanjima?
Imvanex is given by injection under the skin, preferably in the upper arm. People who have not been previously vaccinated against smallpox should receive two 0.5 ml doses, with the second dose given at least 28 days after the first.
Osobe koje nisu prethodno cijepljene protiv velikih boginja trebaju primiti dvije doze od 0,5 ml, a drugu dozu treba dati najranije 28 dana nakon prve.
Condition for lifting the suspension of the marketing authorisations
Uvjet za ukidanje suspenzije odobrenja za stavljanje lijeka u promet
• Bioequivalence vis-à-vis an EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
• Bioekvivalencija u odnosu na referentni lijek odobren u EU-u dokazana je na temelju relevantnih podataka, sukladno sa zahtjevima iz članka 10.
For the suspension of the marketing authorisations referred to in annex IB to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holder(s)
Kako bi se ukinula suspenzija odobrenja za stavljanje lijeka u promet iz Priloga I.B, nadležna tijela država članica osiguravaju da nositelj/nositelji odobrenja za stavljanje lijeka u promet ispune sljedeće uvjete:
(Invented) name Strength Pharmaceutical Form Route of Administration
Farmaceutski oblik Put primjene
1 pre-filled pen + 1 pre-filled pen
1 napunjena brizgalica+ 1 napunjena brizgalica
Solution for injection
Otopina za injekciju Za potkožnu primjenu
This summary was last updated in 09-2015.
Ovaj sažetak je posljednji put ažuriran u 09.2015.
Out of 972 infusions, 84% were rated as bringing about ‘good' or ‘excellent' responses.
Od 972 infuzije, 84 % je ocijenjeno „dobrim” ili „odličnim” odgovorima.
The full EPAR for BeneFIX can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek BeneFIX nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for BeneFIX on 27 August 1997.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek BeneFIX na snazi u Europskoj uniji od 27. kolovoza 1997.
In previously treated patients, 82% of the 693 bleeding episodes treated resolved after a single infusion of BeneFIX.
U prethodno liječenih bolesnika, 82 % od 693 liječenih epizoda krvarenja uklonjeno je nakon jedne infuzije lijeka BeneFIX.