FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the reconstituted solution is stable for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration.
Slovenian: Rekonstituirana raztopina je stabilna 8 ur pri 5 °C in 25 °C, shranjena v originalni viali in/ali injekcijski brizgi.
English: • fainting, dizziness or light-headedness in the past
Slovenian: • ste v preteklosti kdaj izgubili zavest, bili omotični ali imeli vrtoglavico,
English: Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality* Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*,
Slovenian: Zelo pogosti zmanjšan tek Pogosti dehidracija, hipokaliemija*, hiponatriemija*, nenormalne koncentracije glukoze v krvi*, hipokalciemija*, encimske motnje*
English: Very Common Pneumonia* Common
Slovenian: Pogosti okužba sečil *
English: Bortezomib Hospira 3 mg powder for solution for injection bortezomib
Slovenian: Bortezomib Hospira 3 mg prašek za raztopino za injiciranje bortezomib
English: Refer to the Summary of Product Characteristics of thalidomide for additional information.
Slovenian: Za dodatne podatke glejte povzetek glavnih značilnosti zdravila s talidomidom.
English: Change Bortezomib Hospira treatment schedule to 1.3 mg/m2 once per week
Slovenian: zmanjšanje odmerka zdravila Bortezomib Hospira na 1,0 mg/m ali sprememba sheme zdravljenja z zdravilom Bortezomib Hospira na odmerek 1,3 mg/m enkrat na teden
English: Best response n=315
Slovenian: B n = 315
English: Bortezomib Hospira 2.5 mg powder for solution for injection bortezomib
Slovenian: Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje bortezomib
English: Bortezomib Hospira 3.5 mg powder for solution for injection bortezomib
Slovenian: Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje bortezomib
English: Each vial contains 3 mg bortezomib (as a mannitol boronic ester).
Slovenian: Ena viala vsebuje 3 mg bortezomiba (v obliki estra manitola in borove kisline).
English: > 1 prior line of therapy
Slovenian: > 1 predhodna vrsta zdravljenja predhodni vrsti zdravljenja
English: In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Slovenian: Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto zdravljenja, je preskušanje faze III zdravljenja z bortezomibom vodilo do statistično pomembno daljšega časa do napredovanja bolezni, statistično pomembno podaljšanega preživetja in statistično pomembno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
English: When Bortezomib Hospira is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Slovenian: Pri sočasni uporabi zdravila Bortezomib Hospira z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
English: Bortezomib Hospira is available for intravenous or subcutaneous administration.
Slovenian: Zdravilo Bortezomib Hospira se daje intravensko ali subkutano.
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Slovenian: Porazdelitev Po enkratnem ali večkratnem intravenskem odmerjanju 1,0 mg/m2 ali 1,3 mg/m2 pri bolnikih z diseminiranim plazmocitomom je bil srednji volumen porazdelitve (Vd) 1.659 l do 3.294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
English: Bortezomib Hospira 1 mg powder for solution for injection
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Slovenian: Varnostni profil bortezomiba pri 240 bolnikih, zdravljenih z bortezomibom v odmerku 1,3 mg/m2 telesne površine, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom
English: • In cycles 5 to 9, bortezomib is administered once weekly on days 1, 8, 22 and 29.
Slovenian: V ciklih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
English: 72d
Slovenian: 27 mesecev
English: Common Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic
Slovenian: Občasni pankreatitis (vključno s kroničnim)*, hematemeza, otekanje ustnic*, obstrukcija prebavil (vključno z obstrukcijo tankega črevesa, ileusom)*, neprijeten občutek v trebuhu, razjede v ustih*, enteritis*, gastritis*, krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s Clostridium difficile)*, ishemični kolitis
English: You should tell your doctor if you have any of the following:
Slovenian: Opozorila in previdnostni ukrepi Zdravniku povejte, če:
English: 66d
Slovenian: 56,4 mesecev
English: Progressive multifocal leukoencephalopathy (PML)
Slovenian: Limfom plaščnih celic (MCL)
English: Uncommon Angioedema
Slovenian: Občasni anafilaktična reakcija
English: Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Slovenian: Občasni sindrom tumorske lize, zastoj rasti*, hipomagneziemija*, hipofosfatemija*, hiperkaliemija*, hiperkalciemija*, hipernatriemija*, nenormalne koncentracije sečne kisline*, sladkorna bolezen*, zastajanje tekočine
English: > 1.5 x -3 x ULN Any Reduce Bortezomib Hospira to 0.7 mg/m 2 in the first treatment cycle.
Slovenian: Zmanjšanje odmerka zdravila Bortezomib Hospira v prvem ciklu zdravljenja na 0,7 mg/m2.
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Slovenian: Na voljo so omejeni podatki o ponovnem zdravljenju z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
English: Bortezomib Hospira 3.5 mg powder for solution for injection
Slovenian: Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje
English: No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Slovenian: Pri dodatku bortezomiba standardni pediatrični pre-B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
English: Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Slovenian: Neželeni učinek Bolezni živčevja Zelo pogosti nevropatije*, periferna senzorična nevropatija, disestezija*, nevralgija*
English: Bortezomib Hospira treatment must be initiated under supervision of a physician experienced in the treatment of cancer patients, however Bortezomib Hospira may be administered by a healthcare professional experienced in use of chemotherapeutic agents.
Slovenian: Zdravljenje z zdravilom Bortezomib Hospira mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem onkoloških bolnikov.
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib -containing regimen were retreated upon progression.
Slovenian: Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z bortezomibom so izvedli odprto, enoskupinsko preskušanje faze II MMY-2036 (RETRIEVE).Stotrideset bolnikov (starih ≥ 18 let) z diseminiranim plazmocitomom, ki so predhodno imeli vsaj delni odziv na zdravljenje z bortezomibom so ponovno zdravili po napredovanju bolezni.
English: B=bortezomib; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
Slovenian: B = bortezomib; Dx = deksametazon; T = talidomid
English: Bortezomib Hospira 3 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3 mg powder for solution for injection must be carefully reconstituted with 3 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3 mg prašek za raztopino za injiciranje morate previdno rekonstituirati s 3 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Slovenian: Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
English: Common Leukopenia*, Lymphopenia* Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*,
Slovenian: Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija*, levkopenija*, anemija*, limfopenija*
English: Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 3,5 mg viale: previdno dodajte 3,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: 9/l on a Bortezomib Hospira dosing day (other than day 1)
Slovenian: • Če je na dan odmerjanja zdravila Bortezomib Hospira (razen dneva 1) število trombocitov ≤ 30 x 10
English: Preparation of the 2.5 mg vial: carefully add 2.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 2,5 mg viale: previdno dodajte 2,5 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: Patients eligible for stem cell transplantation
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Subcutaneous use: Add 0.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Slovenian: Subkutana uporaba: dodajte 0,4 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
English: Intravenous use: Add 2.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 2,5 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: Bortezomib Hospira 3 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3 mg powder for solution for injection must be carefully reconstituted with 1.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 1,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3.5 mg powder for solution for injection must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati s 1,4 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3.5 mg powder for solution for injection must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Slovenian: Po najmanj 6 mesecih po predhodnem zdravljenju so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m (n = 93) ali ≤ 1,0 mg/m2 (n = 37).
English: Antiviral prophylaxis is recommended in patients being treated with Bortezomib Hospira.
Slovenian: Bolnik prejme šest ciklov zdravljenja z zdravilom Bortezomib Hospira.
English: Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 3,5 mg viale: previdno dodajte 1,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: Intravenous use: Add 1 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 1 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: Preparation of the 3 mg vial: carefully add 1.2 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 3 mg viale: previdno dodajte 1,2 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: Common Muscle spasms*, Pain in extremity, Muscular weakness Uncommon Muscle twitching, Joint swelling, Arthritis*, Joint stiffness,
Slovenian: Zelo pogosti mišično-skeletna bolečina* Pogosti mišični krči*, bolečine v udih, mišična šibkost
English: Bortezomib Hospira 2.5 mg powder for solution for injection
Slovenian: Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje
English: Antiviral prophylaxis was administered to 26% of the patients in the B+M+P arm.
Slovenian: V B+M+P kraku preskušanja je protivirusna zdravila prejelo 26 % bolnikov.
English: Preparation of the 3 mg vial: carefully add 3 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 3 mg viale: previdno dodajte 3 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 2.5 mg powder for solution for injection must be carefully reconstituted with 2.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 2,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 3,5 ml 0,9% raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: Posology for previously untreated multiple myeloma patients not eligible for haematopoietic stem cell transplantation
Slovenian: Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in niso primerni za presaditev krvotvornih matičnih celic
English: Table 2: Recommended posology for Bortezomib Hospira in combination with melphalan and prednisone Twice weekly Bortezomib Hospira (cycles 1-4)
Slovenian: Odmerjanje zdravila Bortezomib Hospira dvakrat na teden (cikli 1-4)
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Slovenian: Sindrom reverzibilne posteriorne levkoencefalopatije (PRES - Posterior Reversible Encephalopathy Syndrome)
English: Pruritus*, Dermatitis*, Rash*
Slovenian: Zelo pogosti bolezni las* Pogosti srbenje*, dermatitis*, izpuščaj*
English: The benefit/risk ratio should be considered prior to continuing Bortezomib Hospira therapy.
Slovenian: Pred nadaljevanjem zdravljenja z zdravilom Bortezomib Hospira je potrebno oceniti razmerje med koristjo in tveganjem.
English: Subcutaneous use: Add 1.2 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Slovenian: Subkutana uporaba: dodajte 1,2 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
English: Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Slovenian: Občasni tremor, periferna senzorična in motorična nevropatija, diskinezija*, motnje koordinacije in ravnotežja v malih možganih*, izguba spomina (brez demence)*, encefalopatija*, posteriorni reverzibilni encefalopatični sindrom nevrotoksičnost, motnje s krči*, postherpetična nevralgija, motnje govora*, sindrom nemirnih nog, migrena, išias, motnje pozornosti, nenormalni refleksi*, parozmija
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 2.5 mg powder for solution for injection must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Vsako 10 ml vialo zdravila Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: • different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
Slovenian: • Različne zahteve za rekonstitucijo zdravila pri i.v.
English: Subcutaneous use: Add 1 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Slovenian: Subkutana uporaba: dodajte 1 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
English: Preparation of the 2.5 mg vial: carefully add 1 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 2,5 mg viale: previdno dodajte 1 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: Intravenous use: Add 3 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 3 ml 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: Bortezomib Hospira is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21 day treatment cycle.
Slovenian: Priporočeni odmerek je 1,3 mg/m telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21-dnevnem ciklu zdravljenja.
English: 1.1 Preparation of the 1 mg vial: carefully add 0.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 1 mg viale: previdno dodajte 0,4 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.
English: Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Slovenian: Subkutana uporaba: dodajte 1,4 ml 0,9% raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
English: Day 1 -- -- Day 4 Day 8 Day rest period
Slovenian: 4 Dan 8 Dan premor Dan
English: B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Slovenian: V 3. tednu 1. cikla se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg, in na 200 mg v 2. ciklu, če bolnik dobro prenaša odmerek 100 mg.
English: Bortezomib Hospira 1 mg powder for solution for injection Each 5 ml vial of Bortezomib Hospira 1 mg powder for solution for injection must be carefully reconstituted with 0.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Vsako 5 ml vialo zdravila Bortezomib Hospira 1 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 0,4 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: Bortezomib Hospira 1 mg powder for solution for injection Each 5 ml vial of Bortezomib Hospira 1 mg powder for solution for injection must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Vsako 5 ml vialo zdravila Bortezomib Hospira 1 mg prašek za raztopino za injiciranje morate previdno rekonstituirati z 1 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
English: Thrombocytopenia*, Neutropenia*, Anaemia*
Slovenian: Občasni angioedem #, preobčutljivost*
English: There have been fatal cases of inadvertent intrathecal administration of bortezomib.
Slovenian: Nenamerno intratekalno dajanje bortezomiba se je končalo s smrtnimi primeri.
English: B (1.3 mg/m
Slovenian: B (1,3 mg/m dan 1, 4
English: Common Hepatic enzyme abnormality* Uncommon Hepatotoxicity (inc liver disorder), Hepatitis*, Cholestasis Rare
Slovenian: Občasni hepatotoksičnost (vključno z boleznimi jeter), hepatitis*, holestaza
English: Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough* Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage
Slovenian: Občasni pancitopenija*, febrilna nevtropenija, koagulopatija*, levkocitoza*, limfadenopatija, hemolitična anemija
English: Bortezomib Hospira is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8 and 11 in a 21-day treatment cycle.
Slovenian: Priporočeni odmerek je 1,3 mg/m telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 28-dnevnem ciklu zdravljenja.
English: 1.1 Preparation of the 1mg vial: carefully add 1mlof sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Slovenian: Priprava 1 mg viale: previdno dodajte 1 ml sterilne 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje v vialo s praškom zdravila Bortezomib Hospira.