FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustment is not required for patients with renal impairment or who are on intermittent haemodialysis (see section 5.2).
Slovenian: Pri bolnikih z ledvično okvaro ali pri tistih, ki se zdravijo z intermitentno hemodializo, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: 3 years
Slovenian: Neodprte viale: 3 leta
English: • bleeding from the mouth
Slovenian: • krvavitev v ustih,
English: Defitelio 6.25 mg/kg was administered intravenously over 2 hours to subjects every 6 hours.
Slovenian: Preskušanci so dobivali zdravilo Defitelio v odmerku 6,25 mg/kg kot 2 uri trajajočo intravensko aplikacijo na vsakih 6 ur.
English: Talk to your doctor before using Defitelio:
Slovenian: Pred začetkom uporabe zdravila Defitelio se posvetujte z zdravnikom:
English: Defitelio is a medicine that contains the active substance defibrotide.
Slovenian: Kaj je zdravilo Defitelio in za kaj ga uporabljamo Defitelio je zdravilo, ki vsebuje učinkovino defibrotid.
English: Survival by Day+100
Slovenian: Živeči na 100.+ dan
English: Phone: +39 031 5373200 Fax: +39 031 5373241 info@gentium.it
Slovenian: 22079 Italija tel.: +39 031 5373200 faks: +39 031 5373241 info@gentium.it
English: Depending on the type and amount of diluent the colour of the diluted solution may vary from colourless to light yellow.
Slovenian: Barva razredčene raztopine lahko niha od brezbarvne do svetlo rumene, kar je odvisno od vrste in količine redčila.
English: NAME OF THE MEDICINAL PRODUCT Defitelio 80 mg/mL concentrate for solution for infusion
Slovenian: IME ZDRAVILA Defitelio 80 mg/ml koncentrat za raztopino za infundiranje
English: What Defitelio looks like and contents of the pack Defitelio is a clear light yellow to brown concentrate for solution for infusion, free from particulate matter or turbidity.
Slovenian: Zdravilo Defitelio je bister, svetlo rumen do rjav koncentrat za raztopino za infundiranje, ki ne vsebuje delcev in ni moten.
English: Vascular disorders Very common
Slovenian: Žilne bolezni Zelo pogosti hipotenzija
English: − If you get any side effects, talk to your doctor.
Slovenian: − Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: It can be diluted with 5% glucose solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion, to a suitable concentration to permit infusion over 2 hours.
Slovenian: S 5-odstotno raztopino glukoze za infundiranje ali raztopino za infundiranje z natrijevim kloridom 9 mg/ml (0,9 %) se lahko razredči na ustrezno koncentracijo, ki omogoča dvourno infundiranje.
English: Measure 2 In order to provide comparative data on efficacy, the MAH will submit
Slovenian: Za zagotovitev primerjalnih podatkov o učinkovitosti bo imetnik dovoljenja za promet z zdravilom predložil:
English: Defitelio 80 mg/mL concentrate for solution for infusion defibrotide
Slovenian: Defitelio 80 mg/ml koncentrat za raztopino za infundiranje defibrotid
English: Skin and subcutaneous tissue disorders Common
Slovenian: Bolezni kože in podkožja Pogosti izpuščaj pruritus petehije
English: Defitelio is not recommended in children less than 1 month of age.
Slovenian: Otroci in mladostniki Uporaba zdravila Defitelio ni priporočljiva pri otrocih, mlajših od 1 meseca.
English: The combined volumes of Defitelio should be added to the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion.
Slovenian: Združeno prostornino zdravila Defitelio je treba dodati raztopini za infundiranje z natrijevim kloridom 9 mg/ml (0,9 %) ali 5-odstotno glukozo.
English: Temporary discontinuation of Defitelio is recommended in patients who undergo surgery or invasive procedures at significant risk of major bleeding.
Slovenian: Pri bolnikih, pri katerih bo opravljen kirurški poseg ali invazivni posegi s pomembnim tveganjem za obsežno krvavitev, je priporočljivo začasno prekiniti uporabo zdravila Defitelio.
English: There is limited efficacy and safety data on doses above this level and consequently it is not recommended to increase the dose above 25 mg/kg/day.
Slovenian: Povečanje odmerka nad 25 mg/kg/dan ni priporočljivo, saj so podatki o učinkovitosti in varnosti nad to ravnijo omejeni.
English: Respiratory, thoracic and mediastinal disorders Common
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti pljučna krvavitev epistaksa
English: Dose-Finding (25mg/kg/day arm)
Slovenian: Ugotavljanje odmerka (skupina s 25 mg/kg/dan)
English: A volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 5% solution for infusion from the infusion bag should be withdrawn and discarded, equal to the total volume of Defitelio solution to be added.
Slovenian: Prostornino raztopine za infundiranje z natrijevim kloridom 9 mg/ml (0,9-%) ali 5-% glukozo, ki mora biti enaka skupni prostornini raztopine zdravila Defitelio, ki se bo dodala, je treba izvleči iz vrečke in jo zavreči.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: • bleeding in general
Slovenian: • splošna krvavitev,
English: Before dilution, each vial should be inspected for particles.
Slovenian: Pred redčenjem vsako vialo preglejte in se prepričajte, da v njej ni delcev.
English: However, tell your doctor or healthcare professional if you think that a dose has been forgotten.
Slovenian: Če pa menite, da so pozabili na odmerek, o tem obvestite zdravnika ali zdravstvenega delavca.
English: Alive at Day +100 VOD resolved by Day +100
Slovenian: VOB izzvenela do 100.+ dneva
English: Six patients with an estimated glomerular filtration rate <30 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease equation) and not currently on dialysis were compared to 6 healthy subjects with similar baseline demographics.
Slovenian: (izračunano z enačbo prilagoditve prehrane pri ledvični bolezni), ki se sočasno niso zdravili z dializo, so primerjali s 6 zdravimi osebami s podobnimi izhodiščnimi demografskimi značilnostmi.
English: Gastrointestinal haemorrhage Vomiting
Slovenian: Bolezni prebavil Pogosti gastrointestinalna krvavitev bruhanje diareja navzea hematemeza krvavitev v ustih
English: How to store Defitelio
Slovenian: Shranjevanje zdravila Defitelio
English: Hydrochloric acid (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi natrijev citrat dihidrat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: Melaena
Slovenian: VIALA
English: Ecchymosis
Slovenian: Občasni ekhimoza
English: Cerebral haemorrhage
Slovenian: • črevesna krvavitev,
English: Conjunctival haemorrhage
Slovenian: Razvoj zarodka/ploda
English: Haematuria
Slovenian: Presnova
English: • bleeding into the skin
Slovenian: • kožna krvavitev,
English: The solution is clear light yellow to brown, free from particulate matter or turbidity.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Raztopina je bistra, svetlo rumena do rjava, brez delcev in motnosti.
English: Possible side effects.
Slovenian: Morebitne interakcije z drugimi zdravili
English: Pulmonary haemorrhage Epistaxis
Slovenian: Občasni hemotoraks
English: How to store Defitelio.
Slovenian: Kaj vsebuje zdravilo Defitelio
English: Table 2:
Slovenian: Ukrep 2
English: • nausea
Slovenian: • srbenje,
English: 19 May 2010
Slovenian: 19. maj 2010
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Slovenian: Dopis, s katerim družba Agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“.
English: The Committee had concerns about its effect on blood pressure and the potential risk of toxic effects in the liver.
Slovenian: Odbor je izrazil zadržke glede učinka na krvni tlak in možnega tveganja toksičnih učinkov na jetra.
English: Two of the studies involved 1,929 patients with knee osteoarthritis while the third study involved 810 patients with hip osteoarthritis.
Slovenian: V dveh študijah je sodelovalo 1 929 bolnikov z osteoartritisom kolena, v tretji študiji pa 810 bolnikov z osteoartritisom kolka.
English: The main measure of effectiveness was based on how patients rated their pain and disease activity after 13 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je temeljilo na subjektivni oceni bolečine in bolezenske aktivnosti bolnikov po 13 tednih zdravljenja.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials.
Slovenian: Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih.
English: The effects of Beprana were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Beprana so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Naproxen is a non-steroidal anti-inflammatory drug (NSAID).
Slovenian: Naproksen je nesteroidno protivnetno zdravilo (NSAID).
English: What is Beprana?
Slovenian: Kaj je zdravilo Beprana?
English: It is expected to counterbalance the effect of Naproxen of increasing blood pressure.
Slovenian: Pričakovali so, da bo uravnotežil učinek naproksena, ki povečuje krvni tlak.
English: Withdrawal of the marketing authorisation application for Beprana (naproxcinod)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Beprana (naprokscinod)
English: It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Slovenian: Deluje tako, da zavira encim, imenovan ciklooksigenaza, ki tvori prostaglandine, snovi, vpletene v vnetni proces.
English: Three main studies in patients were carried out, comparing Beprana with naproxen (another medicine used in osteoarthritis) and placebo (a dummy treatment).
Slovenian: Izvedene so bile tri glavne študije, v katerih so zdravilo Beprana primerjali z naproksenom (drugim zdravilom, ki se uporablja pri osteoartritisu) in placebom (zdravilom brez zdravilne učinkovine).
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Beprana could not have been approved for the relief of signs and symptoms of osteoarthritis of the knee and hip.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Beprana ni mogoče odobriti za lajšanje znakov in simptomov osteoartritisa kolena in kolka.
English: On 19 April 2011, NicOx S. A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Beprana in adults for the relief of signs and symptoms of osteoarthritis of the knee and hip.
Slovenian: Družba NicOx S.A. je dne 19. aprila 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Beprana, namenjenim lajšanju znakov in simptomov osteoartritisa kolena in kolka pri odraslih.
English: Nitric oxide is a vasodilator, a substance that causes the widening of blood vessels.
Slovenian: Dušikov oksid je vazodilatator, snov, ki povzroča širjenje krvnih žil.
English: The active substance in Beprana, naproxcinod, is converted in the body into the drug naproxen and a chemical that releases nitric oxide.
Slovenian: Zdravilna učinkovina v zdravilu Beprana, naprokscinod, se v telesu pretvori v zdravilo naproksen in kemično snov, ki sprošča dušikov oksid.
English: Beprana was expected to be used to relieve the signs and symptoms of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults.
Slovenian: Zdravilo Beprana naj bi se uporabljalo za lajšanje znakov in simptomov osteoartritisa (zatekanje in bolečine v sklepih) kolena in kolka pri odraslih.
English: The CHMP noted that while there was evidence showing that Beprana was effective in relieving the signs and symptoms of osteoarthritis of the knee and hip, its benefits were not sufficient to outweigh the identified risks.
Slovenian: CHMP je menil, da sicer obstajajo dokazi o učinkovitosti zdravila Beprana pri lajšanju znakov in simptomov osteoartritisa kolena in kolka, vendar pa njegove koristi niso zadostne, da bi odtehtale znana tveganja.
English: How is Beprana expected to work?
Slovenian: Kako naj bi zdravilo Beprana delovalo?
English: What was Beprana expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Beprana uporabljalo?
English: By reducing the production of prostaglandins, Beprana is expected to reduce the inflammation and pain seen in osteoarthritis.
Slovenian: Pričakovali so, da bo zdravilo Beprana z zmanjšanjem tvorjenja prostaglandinov zmanjšalo tudi vnetje in bolečino, ki ju povzroča osteoartritis.
English: Beprana is a medicine that contains the active substance naproxcinod.
Slovenian: Beprana je zdravilo, ki vsebuje zdravilno učinkovino naprokscinod.
English: Withdrawal of the marketing authorisation application for Beprana (naproxcinod) EMA/364651/2011
Slovenian: EMA/364651/2011
English: It is available as capsules (1.5, 3, 4.5 and 6 mg).
Slovenian: Na voljo je v obliki kapsul (1,5, 3, 4,5 in 6 mg).
English: EMEA/H/C/002036
Slovenian: EMA/383424/2015 EMEA/H/C/002036
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Actavis on 16 June 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Rivastigmine Actavis, veljavno po vsej Evropski uniji, izdala 16. junija 2011.
English: The full EPAR for Rivastigmine Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rivastigmine Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This means that Rivastigmine Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Exelon.
English: Rivastigmine Actavis should be given twice a day, with morning and evening meals.
Slovenian: Zdravilo Rivastigmine Actavis se daje dvakrat na dan ob zajtrku in večerji.
English: Rivastigmine Actavis rivastigmine
Slovenian: Rivastigmine Actavis rivastigmin
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Actavis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rivastigmine Actavis.
English: For more information about treatment with Rivastigmine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Rivastigmine Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Slovenian: Pri bolnikih z alzheimerjevo demenco ali demenco zaradi parkinsonove bolezni v možganih odmirajo določene živčne celice, zaradi česar se znižajo ravni živčnega prenašalca acetilholina (kemične snovi, ki omogoča medsebojno komunikacijo med živčnimi celicami).
English: 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 Rivastigmine Actavis.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Treatment with Rivastigmine Actavis should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Slovenian: Zdravljenje z zdravilom Rivastigmine Actavis mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem alzheimerjeve bolezni ali demence pri bolnikih s parkinsonovo boleznijo.
English: Rivastigmine Actavis is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Slovenian: Zdravilo Rivastigmine Actavis se uporablja za zdravljenje bolnikov z blago do zmerno hudo alzheimerjevo demenco, tj. napredujočo okvaro možganov, ki postopoma prizadene spomin, intelektualne zmožnosti in vedenje.
English: Because Rivastigmine Actavis 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.
Slovenian: Ker je zdravilo Rivastigmine Actavis generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Rivastigmine Actavis?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Rivastigmine Actavis ?
English: It can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Slovenian: Zdravilo se lahko uporablja tudi za zdravljenje blage do zmerno hude demence pri bolnikih s parkinsonovo boleznijo.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Actavis by the patient.
Slovenian: Zdravljenje se lahko začne samo ob prisotnosti negovalca, ki redno nadzoruje uporabo zdravila Rivastigmine Actavis pri bolniku.
English: Rivastigmine Actavis is a ‘generic medicine'.
Slovenian: Rivastigmine Actavis je „generično zdravilo“.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Slovenian: Pri bolnikih, ki prenašajo navedeni odmerek, se lahko ta postopoma povečuje za 1,5 mg, vendar ne pogosteje kot vsaka dva tedna, dokler se ne doseže stalni odmerek 3 do 6 mg dvakrat na dan. Za doseg največje učinkovitosti se uporabi največji odmerek, ki ga bolnik še prenaša, vendar ta ne sme preseči 6 mg dvakrat na dan.
English: The Committee recommended that Rivastigmine Actavis be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Rivastigmine Actavis izda dovoljenje za promet.
English: Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Slovenian: Rivastigmin deluje tako, da zavira encima, ki razgrajujeta acetilholin: acetilholinesterazo and butirilholinesterazo.
English: Other information about Rivastigmine Actavis
Slovenian: Druge informacije o zdravilu Rivastigmine Actavis
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to increase in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Slovenian: Zdravilo Rivastigmine Actavis z zaviranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi alzheimerjeve demence in demence zaradi parkinsonove bolezni ublažijo.
English: The CHMP concluded that, in accordance with EU requirements, Rivastigmine Actavis has been shown to have comparable quality and to be bioequivalent to Exelon.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Rivastigmine Actavis primerljivo raven kakovosti kot zdravilo Exelon ter da mu je biološko enakovredno.
English: Rivastigmine Actavis is a medicine containing the active substance rivastigmine.
Slovenian: Rivastigmine Actavis je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
English: The active substance in Rivastigmine Actavis, rivastigmine, is a dementia medicine.
Slovenian: Zdravilna učinkovina zdravila Rivastigmine Actavis, rivastigmin, je zdravilo proti demenci.
English: Because Rivastigmine Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Slovenian: Ker je zdravilo Rivastigmine Actavis generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Exelon.
English: Why has Rivastigmine Actavis been approved?
Slovenian: Zakaj je bilo zdravilo Rivastigmine Actavis odobreno?
English: What is Rivastigmine Actavis used for?
Slovenian: Za kaj se zdravilo Rivastigmine Actavis uporablja?
English: Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da koristi zdravila Rivastigmine Actavis, tako kot pri zdravilu Exelon, odtehtajo znana tveganja.
English: How has Rivastigmine Actavis been studied?
Slovenian: Kako je bilo zdravilo Rivastigmine Actavis raziskano?
English: How is Rivastigmine Actavis used?
Slovenian: Kako se zdravilo Rivastigmine Actavis uporablja?
English: What is Rivastigmine Actavis?
Slovenian: Kaj je zdravilo Rivastigmine Actavis?
English: How does Rivastigmine Actavis work?
Slovenian: Kako zdravilo Rivastigmine Activis deluje?
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da bodo uveljavljeni vsi spodaj opisani pogoji oziroma omejitve v zvezi z varno in učinkovito uporabo zdravila.
English: • Velcade 3.5mg can be administered both intravenously and subcutaneously while Velcade 1mg can be administered only intravenously
Slovenian: • Zdravilo VELCADE 3,5 mg se lahko daje intravensko in subkutano, zdravilo VELCADE 1 mg pa samo intravensko.
English: Prior to launch of Velcade 3.5mg new dual route of administration (subcutaneous and intravenous) package, in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se bo pred začetkom trženja novega, dvojnega načina uporabe zdravila VELCADE 3,5 mg (subkutana in intravenska uporaba), v vsaki državi članici s pristojnim nacionalnim organom države dogovoril za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce.
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Slovenian: • Možna tveganja napak pri dajanju zdravila, vključno z informacijami o prevelikem odmerjanju,
English: • SmPC
Slovenian: ali subkutani (s.c.)
English: The MAH shall ensure that, at launch of Velcade 3.5mg new dual route package and thereafter, all healthcare professionals involved in the prescribing, dispensing, handling or administration of Velcade 3.5mg are provided with educational material.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo ob začetku trženja novega, dvojnega načina uporabe zdravila VELCADE 3,5 mg in še naprej zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali ali uporabljali zdravilo prejeli izobraževalno gradivo.
English: • that Velcade 1mg is only for IV use
Slovenian: • Zdravilo VELCADE 1 mg se lahko uporablja samo intravensko.
English: • dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Velcade (both IV and SC use) required for different body surface areas.
Slovenian: • Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila VELCADE (za i.v.