natgillin/translations-raw huggingface dataset:
Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio vs. warfarin; CI = Confidence Interval; N = number of subjects in safety population; n = number of events; CRNM = clinically relevant non-major a On-Treatment Period: Time from first dose of study drug to last dose plus 3 days.
Okrajšave:ICH = intrakranialna krvavitev,HR = razmerje tveganja proti varfarinu,CI = interval zaupanja, CRNM = klinično pomembna krvavitev, ki ni bila velika, n = število preiskovancev z dogodki,N = število preiskovancev v populaciji za proučevanje varnosti.
Roteas 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172).
Roteas 60 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rumeni železov oksid (E172).
Roteas 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172).
Roteas 30 mg:hipromeloza (E464), makrogol 8000, titanov dioksid (E171), smukec, karnauba vosek, rdeči železov oksid (E172);
Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
Glienicker Weg 125
Eye disorders Conjunctival/Scleral haemorrhage
Bolezni sečil makroskopska hematurija/uretralna krvavitev pogosti
Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Preglednica 9: Število intrakranialnih krvavitvenih dogodkov po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, analiza varnosti med zdravljenjema
Concomitant use of Roteas with P-glycoprotein (P-gp) inhibitors In patients concomitantly taking Roteas and the following P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is 30 mg Roteas once daily (see section 4.5).
Sočasna uporaba zdravila Roteas z inhibitorji P-glikoproteina (P-gp) Pri bolnikih, ki sočasno jemljejo zdravilo Roteas in naslednje inhibitorje P-gp: ciklosporin,
Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 15 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b);
Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 60 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
Roteas 30 mg film-coated tablets
Roteas 30 mg filmsko obložene tablete edoksaban
Roteas 60 mg film-coated tablets
Roteas60 mg filmsko obložene tablete edoksaban
• Roteas is an oral anticoagulant factor Xa inhibitor.
INFORMACIJE ZA ZDRAVSTVENE DELAVCE • Zdravilo Roteas je peroralen zaviralec antikoagulacijskega faktorja Xa.
Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Preglednica 8: Število smrtnih krvavitvenih dogodkov po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, analiza varnosti med zdravljenjema
Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b).
Roteas 30 mg: jedro tablete: manitol (E421), predgelirani škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b);
Hepatic impairment Roteas is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Okvara jeter Pri bolnikih s hudo okvaro jeter uporabazdravila Roteasni priporočljiva (glejte poglavji 4.2 in 5.2).
Table 7: Number of Major Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Preglednica 7: Število velikih krvavitvenih dogodkov po kategorijah očistka kreatinina v študiji ENGAGE AF-TIMI 48, analiza varnosti med zdravljenjema
15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”.
Oranžne, okrogle filmsko obložene tablete,premera 6,7 mm, z vtisnjenim napisom “DSC L15”.
• Bleeding in the bowel
• izpuščaj, • krvavitev v črevesu,
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 60 MG
PRETISNI OMOT S 14 FILMSKO OBLOŽENIMI TABLETAMI ZA 60 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 30 MG
PRETISNI OMOT S 14 FILMSKO OBLOŽENIMI TABLETAMI ZA 30 MG
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 se določi individualno po skrbni oceni koristi zdravljenja glede na tveganje za krvavitve(glejte poglavje 4.4).
Management of bleeding
Ukrepi pri krvavitvah
• bleeding disorders
• znotrajlobanjska krvavitev,
Body weight For patients with body weight ≤ 60 kg, the recommended dose is 30 mg Roteas once daily (see section
Pri bolnikih s telesno maso ≤ 60 kg je priporočeni odmerek 30 mg zdravila Roteas enkrat na dan (glejte poglavje 5.2).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).
GVT in PE pri odraslih (za hemodinamično nestabilne bolnike s PE glejte poglavje 4.4).
Immune system disorders Hypersensitivity
Bolezni imunskega sistema preobčutljivost občasni anafilaktična reakcija redki alergijski edem redki
First Haemorrhagic Stroke n Event Rate (%/yr)b
Prva hemoragična možganska kap n pogostnost dogodka (%/leto)b
• severe liver disease
• huda bolezen jeter, • motnje strjevanja krvi,
60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”.
Rumene, okrogle filmsko obložene tablete, premera 10,5 mm, z vtisnjenim napisom “DSC L60”.
The primary efficacy outcome occurred in 14 (3.1%) and 30 (6.2%) of edoxaban and warfarin subjects, respectively [HR (95% CI): 0.50 (0.26, 0.94)].
preiskovancih, ki so prejemali edoksaban oziroma varfarin [HR (95 % CI): 0,50 (0,26, 0,94)].
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Edoksaban se absorbira pretežno v zgornjemgastrointestinalnem (GI) traktu.
NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban
Roteas15 mg filmsko obložene tablete edoksaban
Phone number, practice stamp:
Telefonska številka, žig ambulante: Podpis zdravnika:
Not applicable.
ki ni bila velika).
• The signs or symptoms of bleeding and when to seek attention
Kartica z opozorili za bolnika mora vsebovati naslednja ključna varnostna sporočila: • o znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč;
Do not take Roteas if you are pregnant or breast-feeding.
Nosečnost in dojenje Ne jemljite zdravila Roteas, če ste noseči ali dojite.
• antidepressant medicines called selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors
• antidepresive, imenovane selektivni zaviralci privzema serotonina ali zaviralci privzema serotonina in noradrenalina, se posvetujte z zdravnikom, preden boste začeli jemati zdraviloRoteas, ker zgoraj navedena zdravila lahko zvečajo učinke zdravila Roteasin možnost neželene krvavitve.
Roteas film-coated tablets edoxaban
Zdravilo Roteas filmsko-obložene tablete edoksaban
Haemoptysis
Edoksaban
Hydroxypropylcellulose Magnesium stearate (E470b)
Jedro tablete: manitol (E421) predgelirani škrob krospovidon hidroksipropilceluloza magnezijev stearat (E470b)
No dose reduction is required for concomitant use of amiodarone, quinidine or verapamil (see section
Pri sočasni uporabi amiodarona, kinidina ali verapamila ni potrebno nikakršno zmanjševanje odmerka
• Bleeding in joints
• krvavitev v sklepih,
It is very important to take Roteas before and after the operation exactly at the times you have been told by your doctor.
Zelo pomembno je, da zdravilo Roteas pred kirurškim posegom in po njem jemljete natančno ob predpisanem času, kot vam je svetoval zdravnik.Če je mogoče, nehajte jemati zdravilo Roteas vsaj 24 ur pred operacijo.
Subarachnoid haemorrhage
občasni subarahnoidna krvavitev redki
Please talk to your doctor if you experience any unusual symptoms.
Če opazite kateri koli nenavaden simptom, se pogovorite z zdravnikom.
30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”.
Rožnate, okrogle filmsko obložene tablete, premera 8,5 mm, z vtisnjenim napisom “DSC L30”.
60 mg QD*
60 mg enkrat na dan*
Retroperitoneal haemorrhage
Navzea pogosti retroperitonealna krvavitev redki
• Bleeding from the skin or under the skin
• nenormalni izvidi krvnih preiskav delovanja jeter, • krvavitve v koži ali pod kožo,
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.
Prehod s peroralnih antikoagulantov, ki niso antagonisti vitamina K (dabigatran, rivaroksabanali apiksaban)na zdraviloRoteas
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 60 MG
PRETISNI OMOT Z 10 FILMSKO OBLOŽENIMI TABLETAMI ZA 60 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 30 MG
PRETISNI OMOT Z 10 FILMSKO OBLOŽENIMI TABLETAMI ZA 30 MG
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.
dabigatran, rivaroksaban ali apiksaban)in začnite jemati zdraviloRoteasob času naslednjega načrtovanega odmerka.
Upper GI haemorrhage
Okvara jeter
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
naproksen ali acetilsalicilno kislino),
In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
58 (7,9 %) preiskovancev, ki so prejemali zmanjšan odmerek edoksabana 30 mg, in 92 (12,8 %) preiskovancev, ki so prejemali varfarin, veliko krvavitev ali CRNM dogodek [HR (95 %): 0,62
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 15 MG
PRETISNI OMOT Z 10 FILMSKO OBLOŽENIMI TABLETAMI ZA15 MG
Common (may affect up to 1 in 10 people):
Celoten seznam možnih neželenih učinkov: Pogosti(pojavijo se lahko pri več kot 1 od 10 bolnikov):
Recommended dose
- Navodilo shranite.
Changing from Roteas to vitamin K antagonists (e.g. warfarin) If you currently take 60 mg Roteas:
varfarin) Če trenutno jemljete 60 mg zdravila Roteas:
Discontinue Roteas and start the parenteral anticoagulant at the time of the next scheduled dose of Roteas.
Teh zdravil ne smete uporabljati sočasno.Ukinite zdravilo Roteas in začnite s parenteralnim antikoagulantom ob času naslednjega načrtovanega odmerka zdravila Roteas.
Hepatic impairment
• glavobol,
When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Kadar se uporablja za zdravljenje angine pektoris, je treba zdravljenje prekiniti, če se simptomi po 3 mesecih ne izboljšajo.
In stable angina, these symptoms occur during physical effort.
Pri stabilni angini pektoris se ti simptomi pojavijo med telesnim naporom.
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.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ivabradine Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Ker je zdravilo Ivabradine Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a summary of the European public assessment report (EPAR) for Ivabradine Accord.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ivabradine Accord.
Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Zdravilo Ivabradine Accord je na voljo v obliki tablet (5 in 7,5 mg), njegovo predpisovanje in izdaja je le na recept.
Also, the doctor will consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Zdravnik bi moral prav tako razmisliti o prekinitvi zdravljenja, če zdravilo le omejeno blaži simptome ali znižuje srčni utrip.
The Committee recommended that Ivabradine Accord be approved for use in the EU.
Priporočil je, da se zdravilo Ivabradine Accord odobri za uporabo v EU.
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 zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ivabradine Accord primerljivo raven kakovosti kot zdravilo Procoralan ter da mu je biološko enakovredno.
What measures are being taken to ensure the safe and effective use of Ivabradine Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ivabradine Accord?
Ivabradine Accord therefore reduces or prevents the symptoms of angina.
Zdravilo Ivabradine Accord tako zmanjša ali prepreči simptome angine pektoris.
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.
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Procoralan, zato jih ni treba ponoviti za zdravilo Ivabradine Accord.
As for every medicine, the company provided studies on the quality of Ivabradine Accord.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila 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.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Ivabradine Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
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.
Priporočeni začetni odmerek je 5 mg dvakrat na dan ob obrokih, ta odmerek pa lahko zdravnik odvisno od bolnikovega srčnega utripa ter simptomov pozneje poveča na 7,5 mg dvakrat na dan ali zmanjša na 2,5 mg (polovička petmiligramske tablete) dvakrat na dan.
When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Z zaviranjem tega toka upočasni srčni utrip, tako da ima srce manj dela in potrebuje manj krvi s kisikom.
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).
Zdravilo Ivabradine Accord je zdravilo za bolezni srca, ki se uporablja za zdravljenje simptomov dolgotrajne stabilne angine pektoris (bolečine v prsnem košu, čeljusti in hrbtu zaradi telesnega napora) pri odraslih z boleznijo koronarnih arterij (boleznijo srca, ki jo povzroča zamašitev krvnih žil, ki dovajajo kri v srčno mišico).
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 pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Procoralan, ki je že odobreno v Evropski uniji (EU).
What are the benefits and risks of Ivabradine Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Ivabradine Accord?
For more information about treatment with Ivabradine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ivabradine Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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.
Uporablja se pri bolnikih, ki ne smejo jemati zaviralcev receptorjev beta (druge vrste zdravil za zdravljenje angine pektoris), ali v kombinaciji z zaviralci receptorjev beta pri tistih bolnikih, pri katerih bolezni ni mogoče nadzorovati zgolj s temi zaviralci.
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.
Zdravilo Ivabradine Accord se uporablja tudi pri bolnikih z dolgotrajnim srčnim popuščanjem (kadar srce po telesu ne more črpati dovolj krvi) in normalnim srčnim ritmom, ki pa ne sme biti nižji od 75 utripov na minuto.
For practical information about using Ivabradine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Ivabradine Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Zdravilo se uporablja pri bolnikih z normalnim srčnim ritmom, ki pa ne sme biti nižji od 70 utripov na minuto.
Other information about Ivabradine Accord
Druge informacije o zdravilu Ivabradine Accord
It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.
Uporablja se v kombinaciji s standardnim zdravljenjem, ki vključuje antagoniste adrenergičnih receptorjev beta, ali pri bolnikih, ki teh antagonistov ne smejo jemati.
By lowering the heart rate, Ivabradine Accord reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Zdravilo Ivabradine Accord z upočasnitvijo srčnega utripa zmanjša obremenitev srca ter upočasni napredovanje srčnega popuščanja in ublaži simptome.
What is Ivabradine Accord and what is it used for?
Kaj je zdravilo Ivabradine Accord in za kaj se uporablja?
Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Procoralan odtehtajo znana tveganja.
The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Zdravilna učinkovina v zdravilu Ivabradine Accord, ivabradin, zavira „tok If“ v sinusnem vozlu, ki je naravni „srčni spodbujevalec“, ki uravnava srčni utrip.
The symptoms of angina are caused by the heart muscle not receiving enough oxygenated blood.
Simptome angine pektoris povzroča premajhen dotok krvi s kisikom v srčno mišico.
It is not intended to provide practical advice on how to use Ivabradine Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Ivabradine Accord contains the active substance ivabradine.
Zdravilo Ivabradine Accord vsebuje zdravilno učinkovino ivabradin.
Why is Ivabradine Accord approved?
Zakaj je bilo zdravilo Ivabradine Accord odobreno?
Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Pri bolnikih, starejših od 75 let, se lahko uporabi manjši začetni odmerek 2,5 mg dvakrat na dan. Zdravljenje je treba prekiniti, če je srčni utrip vztrajno pod 50 utripov na minuto ali če se nadaljujejo simptomi bradikardije (počasnega srčnega utripa).
How has Ivabradine Accord been studied?
Kako je bilo zdravilo Ivabradine Accord raziskano?
How does Ivabradine Accord work?
Kako zdravilo Ivabradine Accord deluje?
How is Ivabradine Accord used?
Kako se zdravilo Ivabradine Accord uporablja?
Repeat every 12 to 24 hours.
Ponavljajte vsakih 12 do 24 ur.
• There were also deviations from the final protocol and statistical analysis plan.
• obstajajo tudi odstopanja od končnega protokola in načrta statistične analize.
• Risk Management plan (RMP)
• Načrt za obvladovanje tveganja (RMP)
This association was consistently observed in multivariable analysis.
Ta povezava je bila dosledno ugotovljena v multivariabilni analizi.
This indicates that the system is activated (D).
Tako je sistem aktiviran (D).
If bleeding is not controlled
Če krvavitev ni nadzorovana
• you have been told you have heart disease or are at risk for heart disease.
• so vam povedali, da imate bolezen srca ali pri vas obstaja tveganje za bolezen srca.
This must be checked by an experienced doctor.
To mora preveriti izkušen zdravnik.
The expert group was of the view that the relevant available data sources have been considered.
Strokovna skupina je menila, da so bili upoštevani ustrezni razpoložljivi viri podatkov.
The relevance for clinical practice in the EU (and therefore for the products subject to this procedure) is therefore questioned.
Zato je vprašljiva ustreznost klinične prakse v EU (in torej za zdravila, ki so predmet tega postopka).
The experts emphasized that collaboration between academia, industry and regulators should be encouraged to collect harmonised data through registries.
Strokovnjaki so poudarili, da je treba spodbujati sodelovanje med akademskim svetom, industrijo in regulativnimi organi za zbiranje usklajenih podatkov prek registrov.
• Treatment regimens in EU are different from those in the SIPPET study.
• režimi zdravljenja v EU se razlikujejo od režimov v študiji SIPPET.
• where the bleed is and how serious it is
• mesta krvavitve in kako resna je krvavitev
EXP (End of the 12 month period, if stored at room temperature): ........... Do not use after this date.
EXP (konec 12 mesečnega obdobja, če ga shranjujete pri sobni temperaturi): ............ Ne uporabljajte po tem datumu.
The required dose is determined using the following formulae:
Potrebni odmerek se izračuna z uporabo naslednje formule:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 August 2000
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 4. avgust 2000
During continuous infusion, infusion bags should be changed every 24 hours.
Med kontinuirano infuzijo je treba infuzijske vreče zamenjati vsakih 24 ur.
If you notice any of the following symptoms during injection/infusion:
Če opazite katerega od naslednjih simptomov med injiciranjem/infundiranjem:
• Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
• Takoj uporabite vaš naslednji odmerek in zdravljenje nadaljujte v rednih presledkih, kot vam je svetoval zdravnik.
(pre- and postoperative)
(pred in po posegu)
Published observational studies
Objavljene opazovalne študije
Date of latest renewal: 06 August 2010
Datum zadnjega podaljšanja: 6. avgust 2010
However, please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Ad hoc expert group meeting
Sestanek ad hoc strokovne skupine