natgillin/translations-raw huggingface dataset:
Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 15 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
Changing from Roteas to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Roteas and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Roteas.
Prestanite uzimati Roteas i počnite uzimati antikoagulans koji nije antagonist vitamina K (npr. dabigatran, rivaroksaban ili apiksaban) u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu Roteasa.
EU/1/16/1152/016 10 film-coated tablets EU/1/16/1152/017 14 film-coated tablets EU/1/16/1152/018 28 film-coated tablets EU/1/16/1152/019 30 film-coated tablets EU/1/16/1152/020 56 film-coated tablets EU/1/16/1152/021 60 film-coated tablets EU/1/16/1152/022 84 film-coated tablets EU/1/16/1152/023 90 film-coated tablets EU/1/16/1152/024 98 film-coated tablets EU/1/16/1152/025 100 film-coated tablets EU/1/16/1152/026 10 x 1 film-coated tablets EU/1/16/1152/027 50 x 1 film-coated tablets EU/1/16/1152/028 100 x1 film-coated tablets
EU/1/16/1152/023 90 filmom obloženih tableta EU/1/16/1152/024 98 filmom obloženih tableta EU/1/16/1152/025 100 filmom obloženih tableta EU/1/16/1152/026 10 x 1filmom obložena tableta EU/1/16/1152/027 50 x 1 filmom obložena tableta EU/1/16/1152/028 100 x 1 filmom obložena tableta
Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 60 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
Intra-articular haemorrhage
Intraartikularno krvarenje
≥ 30 to ≤ 50 1,302 63 > 50 to ≤ 70 2,093 85 > 70 to ≤ 90 1,661 45 > 90 to ≤ 110 927 27 > 110 to ≤ 130 497 14
≥ 30 do ≤ 50 1302 63 > 50 do ≤ 70 2093 85 > 70 do ≤ 90 1661 45 > 90 do ≤ 110 927 27 > 110 do ≤ 130 497 14
Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 30 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
The reduction in fatal bleeds was also significant for the edoxaban 60 mg treatment group compared with the warfarin group (0.21%, and 0.38%) [HR (95% CI): 0.55 (0.36, 0.84); p = 0.0059 for superiority], primarily because of the reduction in fatal ICH bleeds [HR (95% CI): 0.58 (0.35, 0.95); p = 0.0312].
0,38%) [HR (95% CI): 0,55 (0,36, 0,84); p = 0,0059 za superiornost], prvenstveno zbog smanjenja intrakranijalnih krvarenja sa smrtnim ishodom [HR (95% CI): 0,58 (0,35, 0,95); p = 0,0312].
Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation
4.1 Terapijske indikacije Prevencija moždanog udara i sistemske embolije u odraslih bolesnika s nevalvularnom fibrilacijom atrija (NVAF) s jednim ili više čimbenika rizika, kao što su kongestivno zatajenje srca, hipertenzija,
EU/1/16/1152/003 10 film-coated tablets EU/1/16/1152/004 14 film-coated tablets EU/1/16/1152/005 28 film-coated tablets EU/1/16/1152/006 30 film-coated tablets EU/1/16/1152/007 56 film-coated tablets EU/1/16/1152/008 60 film-coated tablets EU/1/16/1152/009 84 film-coated tablets EU/1/16/1152/010 90 film-coated tablets EU/1/16/1152/011 98 film-coated tablets EU/1/16/1152/012 100 film-coated tablets EU/1/16/1152/013 10 x 1 film-coated tablets EU/1/16/1152/014 50 x 1 film-coated tablets EU/1/16/1152/015 100 x1 film-coated tablets
EU/1/16/1152/003 10 filmom obloženih tableta EU/1/16/1152/004 14 filmom obloženih tableta EU/1/16/1152/005 28 filmom obloženih tableta EU/1/16/1152/006 30 filmom obloženih tableta EU/1/16/1152/007 56 filmom obloženih tableta EU/1/16/1152/008 60 filmom obloženih tableta EU/1/16/1152/009 84 filmom obložene tablete
• Ciclosporin: Concurrent administration of a single dose of ciclosporin 500 mg with a single dose of edoxaban 60 mg increased edoxaban AUC and Cmax by 73% and 74%, respectively.
30 mg jedanput na dan: • Ciklosporin: Istovremena primjena jedne doze ciklosporina od 500 mg s jednom dozom edoksabana od 60 mg povećala je AUC edoksabana za 73%, a Cmax za 74%.
Your doctor will decide if you should be treated with Roteas and if you should be kept under observation.
Roteasom i trebate li biti pod nadzorom.
Roteas 30 mg film-coated tablets
Roteas 30 mg filmom obložene tablete edoksaban
The secondary composite endpoint of recurrent VTE and all-cause mortality occurred in 138 subjects (3.4%) in the edoxaban group and 158 subjects (3.9%) in the warfarin group [HR (95% CI): 0.87
138 ispitanika (3,4%) u skupini liječenoj edoksabanom i 158 ispitanika (3,9%) u skupini liječenoj varfarinom [HR (95% CI): 0,87 (0,70, 1,10)].
There was a significant risk reduction in favour of the edoxaban 60 mg treatment group compared with the warfarin group in major bleeding (2.75%, and 3.43% per year, respectively) [HR (95% CI): 0.80 (0.71, 0.91); p = 0.0009], ICH (0.39%, and 0.85% per year, respectively) [HR (95% CI): 0.47 (0.34, 0.63); p < 0.0001], and other types of bleeding (Table 6).
CI): 0,80 (0,71, 0,91); p = 0,0009], intrakranijalno krvarenje (0,39% odnosno 0,85% godišnje) [HR (95% CI): 0,47 (0,34, 0,63); p < 0,0001] i drugih vrsta krvarenja (tablica 6).
Procedural haemorrhage
Proceduralno krvarenje
Edoxaban 30 mg once daily was used for subjects with one or more of the following clinical factors: moderate renal impairment (CrCL 30 - 50 mL/min); body weight ≤ 60 kg; concomitant use of specific P-gp inhibitors.
Edoksaban u dozi od 30 mg jedanput na dan primjenjivao se u ispitanika s jednim ili više od sljedećih kliničkih čimbenika: umjereno oštećenje funkcije bubrega (CrCL 30 - 50 ml/min); tjelesna težina
≥ 30 to ≤ 50 1,302 16 > 50 to ≤ 70 2,093 19 > 70 to ≤ 90 1,661 17 > 90 to ≤ 110 927 5 > 110 to ≤ 130 497 2
≥ 30 do ≤ 50 1302 16 > 50 do ≤ 70 2093 19 > 70 do ≤ 90 1661 17 > 90 do ≤ 110 927 5 > 110 do ≤ 130 497 2
Major Bleeding n Event rate (%/yr)a HR (95% CI) p-value ICHb n Event rate (%/yr)a HR (95% CI) Fatal Bleeding n Event rate (%/yr)a HR (95% CI) CRNM Bleeding n Event rate (%/yr)a HR (95% CI) Any Confirmed Bleedingc n Event rate (%/yr)a HR (95% CI) Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio versus warfarin, CI = Confidence Interval, CRNM = Clinically Relevant Non-Major, n = number of subjects with events, N = number of subjects in Safety population, yr = year.
HR (95% CI) Prvi SED n (%/god)a HR (95% CI) Kratice: HR = omjer hazarda naspram varfarinu, CI = interval pouzdanosti, n = broj događaja, mITT = modificirano planirano liječenje, N = broj ispitanika u mITT populaciji, SED = sistemski embolijski događaj, god = godina a Jedan ispitanik može biti prikazan u većem broju redova.
• Feeling sick
• glavobolja • svrbež
Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
Berlin-Chemie Menarini Hrvatska d.o.o. Tel : +385 1 4821 361
• Blood in the urine
• krv u mokraći
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 30 MG
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 14 FILMOM OBLOŽENIH
NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban
Roteas 15 mg filmom obložene tablete edoksaban
Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Roteas Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Roteas at the time of the next scheduled dose.
Prestanite uzimati prethodne lijekove (npr. dabigatran, rivaroksaban ili apiksaban) i počnite uzimati Roteas u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu.
Respiratory, thoracic and mediastinal disorders Epistaxis
Poremećaji dišnog sustava, prsišta i sredoprsja
The average exposure to edoxaban 60 mg (including 30 mg dose reduced) was 2.5 years among 7,012 patients in ENGAGE AF-TIMI 48 and 251 days among 4,118 patients in Hokusai-VTE.
2,5 godina kod 7012 bolesnika u ispitivanju ENGAGE AF-TIMI 48 i 251 dan kod 4118 bolesnika u ispitivanju Hokusai-VTE.
The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
VTE-a treba biti prilagođeno pojedinom bolesniku nakon pažljive procjene koristi od liječenja u odnosu na rizik od krvarenja (vidjeti dio 4.4).
Investigations Liver function test abnormal
Poremećeni nalazi pretraga jetrenih funkcija
• Guidance on switching from or to Roteas treatment
• smjernice za zamjenu drugog lijeka Roteasom i obrnuto
• apixaban
• koprivnjača
Reproductive toxicology
Žene reproduktivne dobi
• Other types of bleeding
• poremećaj krvarenja
Cardiac disorders Pericardial haemorrhage
Makroskopska hematurija/uretralno krvarenje
Intravenous unfractionated heparin (UFH): Discontinue the infusion and start Roteas 4 hours later.
Prekinite infuziju i započnite s primjenom Roteasa nakon 4 sata.
From
U
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 15 MG
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 10 FILMOM OBLOŽENIH
• Headache
• omaglica
First SEE n (%/yr)a
n (%)
In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Roteas is not recommended (see sections 4.4 and 5.2).
Za bolesnike u završnom stadiju bubrežne bolesti (ESRD) (CrCL < 15 ml/min) ili na dijalizi, primjena
Talk to your doctor or pharmacist before taking Roteas,
Obratite se svom liječniku ili ljekarniku prije nego uzmete Roteas: - ako imate povećan rizik od krvarenja, što bi moglo biti u slučaju da imate neko od sljedećih stanja:
Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.
Stoga, pri procjeni stanja svakog bolesnika koji uzima antikoagulans potrebno je uzeti u obzir i mogućnost krvarenja.
Fertility
Urtikarija
Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Tablica 8: Broj krvarenja sa smrtnim ishodom prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiza sigurnosti tijekom liječenjaa
The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major).
Sigurnost primjene u bolesnika s VTE-om (DVT i PE) u ispitivanju Hokusai-VTE Primarni ishod sigurnosti primjene bilo je klinički značajno krvarenje (veliko krvarenje ili klinički značajno, ali ne veliko).
Table 12: Edoxaban Anti-FXa activity by creatinine clearance Edoxaban Dose
Tablica 12: Inhibicijsko djelovanje edoksabana na faktor Xa prema klirensu kreatinina Doza edoksabana CrCL (ml/min)
Uncommon (may affect up to 1 in 100 people):
Manje često (mogu se javiti u najviše 1 na 100 osoba): • druge vrste krvarenja
≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1
> 50 do ≤ 70 2093 8 > 70 do ≤ 90 1661 10 > 90 do ≤ 110 927 2 > 110 do ≤ 130 497 1
Hydroxypropylcellulose Magnesium stearate (E470b)
Jezgra tablete: manitol (E421) prethodno geliran škrob krospovidon hidroksipropilceluloza magnezijev stearat (E470b)
Subdural haemorrhage
Subduralno krvarenje
Upper GI haemorrhage
Prijavljivanje nuspojava
In stable angina, these symptoms occur during physical effort.
Pri stabilnoj angini ti se simptomi javljaju za vrijeme fizičkog napora.
The full EPAR for Ivabradine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Ivabradine Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Dva su lijeka bioekvivalentna kada u tijelu proizvode jednake razine djelatne tvari pa se stoga očekuje i da imaju jednak učinak.
The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Preporučena početna doza je 5 mg dva puta dnevno uz obroke, što liječnik može povećati na 7,5 mg dva puta dnevno ili smanjiti na 2,5 mg (polovicu tablete od 5 mg) dva puta dnevno, ovisno o pulsu i simptomima bolesnika.
Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Ivabradine Accord je dostupan u obliku tableta (5 i 7,5 mg) te se izdaje samo na liječnički recept.
Ivabradine Accord therefore reduces or prevents the symptoms of angina.
Stoga Ivabradine Accord ublažava ili sprječava simptome angine.
This means that Ivabradine Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
To znači da Ivabradine Accord sadrži istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Procoralan.
Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Liječenje treba prekinuti ako je puls kontinuirano niži od 50 otkucaja u minuti ili ako se nastave simptomi bradikardije (sporog pulsa).
Also, the doctor will consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Nadalje, liječnik će razmotriti prekid terapije ako lijek samo ograničeno djeluje na ublažavanje simptoma i smanjenje pulsa.
When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Kada je ta struja blokirana, srčana se frekvencija smanjuje tako da srce mora manje raditi te treba manje oksigenirane krvi.
As for every medicine, the company provided studies on the quality of Ivabradine Accord.
Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Ivabradine Accord.
Because Ivabradine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Ivabradine Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
Ivabradine Accord is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Ivabradine Accord također se koristi u bolesnika s dugoročnim zatajenjem srca (kad srce ne može pumpati dovoljno krvi u ostatak tijela) i normalnim srčanim ritmom od barem 75 otkucaja u minuti.
It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.
Koristi se u kombinaciji sa standardnom terapijom koja uključuje beta-blokatore ili u bolesnika koje se ne može liječiti beta-blokatorima.
Ivabradine Accord ivabradine
Ivabradine Accord ivabradin
The symptoms of angina are caused by the heart muscle not receiving enough oxygenated blood.
Simptome angine uzrokuje stanje pri kojem srčani mišić ne prima dovoljno oksigenirane krvi.
By lowering the heart rate, Ivabradine Accord reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Snižavanjem srčane frekvencije, Ivabradine Accord ublažava napor za srce, te stoga usporava napredak zatajenja srca i poboljšava simptome.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Procoralan, and do not need to be repeated for Ivabradine Accord.
Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim primjenama već su provedena za referentni lijek Procoralan te ih ne treba ponavljati za lijek Ivabradine Accord.
It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by beta-blockers alone.
Koristi se u bolesnika koji ne mogu uzimati beta-blokatore (druga vrsta lijeka za liječenje angine) ili u kombinaciji s beta-blokatorima u bolesnika čiju se bolest ne može kontrolirati samo beta-blokatorima.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Accord has been shown to have comparable quality and to be bioequivalent to Procoralan.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je u skladu sa zahtjevima EU-a potvrđeno da lijek Ivabradine Accord posjeduje usporedivu kvalitetu te je bioekvivalentan lijeku Procoralan.
Ivabradine Accord is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Ivabradine Accord je lijek za srce koji se koristi za liječenje dugotrajne stabilne angine (boli u prsima, vilici ili leđima pri fizičkom naporu) u odraslih s bolešću koronarnih arterija (bolest srca u kojoj su začepljene žile koje srce opskrbljuju krvlju).
The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Lijek se koristi u bolesnika s normalnim srčanim ritmom od barem 70 otkucaja u minuti.
This is a summary of the European public assessment report (EPAR) for Ivabradine Accord.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ivabradine Accord.
What measures are being taken to ensure the safe and effective use of Ivabradine Accord?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ivabradine Accord?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Accord 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 Ivabradine Accord nalaze se u sažetku opisa svojstava i u uputi o lijeku.
For more information about treatment with Ivabradine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Ivabradine Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
The Committee recommended that Ivabradine Accord be approved for use in the EU.
Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ivabradine Accord u EU-u.
It is not intended to provide practical advice on how to use Ivabradine Accord.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Ivabradine Accord.
What is Ivabradine Accord and what is it used for?
Što je Ivabradine Accord i za što se koristi?
For practical information about using Ivabradine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Ivabradine Accord bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
What are the benefits and risks of Ivabradine Accord?
Koje su koristi i rizici od lijeka Ivabradine Accord?
Other information about Ivabradine Accord
Ostale informacije o lijeku Ivabradine Accord
Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Stoga je stav CHMP-a da koristi nadmašuju utvrđene rizike, kao i kod lijeka Procoralan.
The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Ivabradin, djelatna tvar u lijeku Ivabradine Accord, blokira ‘If struju' u sinusnom čvoru, prirodnom elektrostimulatoru koji regulira puls.
Ivabradine Accord contains the active substance ivabradine.
Ivabradine Accord sadrži djelatnu tvar ivabradin.
Why is Ivabradine Accord approved?
Zašto je Ivabradine Accord odobren?
How does Ivabradine Accord work?
Kako djeluje Ivabradine Accord?
How is Ivabradine Accord used?
Kako se Ivabradine Accord koristi?
How has Ivabradine Accord been studied?
Kako je Ivabradine Accord ispitivan?
• There were also deviations from the final protocol and statistical analysis plan.
• Također su postojala odstupanja od završnog protokola i plana statističke analize.
Distribution and elimination
Distribucija i eliminacija
Bio-Set System:
Bio-Set sustav:
Repeat every 12 to 24 hours.
Ponoviti svakih 12 do 24 sata.
The required dose is determined using the following formulae:
Potrebna doza određuje se sljedećim formulama:
• Risk Management plan (RMP)
Plan upravljanja rizicima (RMP)
Wash your hands thoroughly using soap and warm water.
Temeljito operite ruke sapunom i toplom vodom.
20024 Garbagnate Milanese (MI) Italy
20024 Garbagnate Milanese (MI) Italija
Minor including tooth extraction
Manji uključujući vađenje zuba
Date of latest renewal: 06 August 2010
Datum posljednje obnove: 6. kolovoza 2010.
An updated RMP should be submitted:
Nadalje, nadopunjen RMP treba dostaviti:
Check with your doctor, pharmacist or nurse if you are not sure.
Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.
Rare / not known
Vrlo rijetko / nepoznato
This indicates that the system is activated (D).
Time se sustav aktivira (D).
The material should not be warmer than body temperature (not exceed 37 °C).
Materijal ne smije biti topliji od tjelesne temperature (ne više od 37 °C).
Please consult your doctor immediately.
Molimo odmah se obratite liječniku.
Not known (frequency cannot be estimated from the available data): • dysgeusia (strange taste)
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) • disgeuzija (čudan okus)
The solution must be prepared on a clean and dry surface.
Otopina se mora pripremati na čistoj i suhoj površini.
The relevance for clinical practice in the EU (and therefore for the products subject to this procedure) is therefore questioned.
Stoga je upitna relevantnost za kliničku praksu u EU-u (prema tome i za lijekove koji podliježu tom postupku).
• Treatment regimens in EU are different from those in the SIPPET study.
• Režimi liječenja u EU-u razlikuju se od onih u ispitivanju SIPPET.
Package Leaflet: Information for the user
Uputa o lijeku: Informacija za korisnika
This must be checked by an experienced doctor.
To mora provjeriti liječnik s iskustvom.
Laboratory tests
Laboratorijski testovi
The experts emphasized that collaboration between academia, industry and regulators should be encouraged to collect harmonised data through registries.
Stručnjaci su istaknuli da treba poticati suradnju između akademske zajednice, industrijskog sektora i regulatora kako bi se putem registara prikupili usklađeni podatci.
In case of shock, standard medical treatment for shock should be implemented.
U slučaju pojave šoka potrebno je provesti standardno liječenje šoka.
• if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
• ako ste alergični na oktokog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 i na kraju dijela 2)
The expert group was of the view that the relevant available data sources have been considered.
Mišljenje stručne skupine bilo je da su razmotreni relevantni i dostupni izvori podataka.
• the factor VIII level that is needed.
• potrebna razina faktora VIII.
These factors make control of such studies and interpretation of the results challenging.
Ti čimbenici stvaraju poteškoće u kontroli takvih ispitivanja i tumačenju rezultata.
The safety and efficacy of {(Invented) name} in previously untreated patients have not yet been established.
Sigurnost i djelotvornost {(Novoizumljeno) ime} u prethodno neliječenih bolesnika nisu još ustanovljene.
OTHER Bayer-Logo
DRUGO Bayer-Logo