natgillin/translations-raw huggingface dataset:
Based on the data presented, the PRAC was of the view that the product information should be varied to update Section 4.8 the SmPC and relevant section of the package leaflet to add the following: chalazion, blepharitis and Thrombotic Microangiopathy.
Na osnovi pregledanih podatkov, je PRAC mnenja, da so spremembe v informacijah o zdravilu v poglavju 4.8 povzetka glavnih značilnosti zdravila in ustreznem poglavju navodila za uporabo utemeljene.
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia *, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Redki hipermagneziemija*, acidoza, motnje ravnovesja elektrolitov*, čezmerno nabiranje tekočine, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B-kompleksa, pomanjkanje vitamina B12,
NAME OF THE MEDICINAL PRODUCT Bortezomib SUN 3.5 mg powder for solution for injection bortezomib
Navodilo za uporabo Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje bortezomib
Incidence Adverse reaction
Občasni anafilaktična reakcija
Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
V povezavi z zdravljenjem z bortezomibom so poročali o gastrointestinalni in intracerebralni krvavitvi.
In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 7 patients.
V študiji medsebojnega delovanja zdravil, ki je ocenjevala učinek omeprazola, močnega induktorja encima CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), na podlagi podatkov 17 bolnikov, ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
Withhold Bortezomib SUN treatment until symptoms of toxicity have resolved.
SUN, dokler ne minejo znaki toksičnosti.
breathing that becomes shallow, difficult or stops, wheezing - hiccups, speech disorders - increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention - altered levels of consciousness, confusion, memory impairment or loss - hypersensitivity - hearing loss, deafness or ringing in the ears, ear discomfort - hormone abnormality which may affect salt and water absorption - overactive thyroid gland - inability to produce enough insulin or resistance to normal levels of insulin - irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision,
- preobčutljivost - poslabšanje sluha, gluhost ali zvonjenje v ušesih, nelagodje v ušesu - hormonske motnje, ki lahko vplivajo na absorpcijo soli in vode - preveč aktivna žleza ščitnica - nezmožnost tvorbe insulina ali odpornost na normalne koncentracije insulina - draženje ali vnetje oči, čezmerno solzenje, boleče oči, suhe oči, okužbe oči, zatrdlina na veki
Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina, težave pri uriniranju*,
• advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
in s.c. in, da je pri s.c. uporabi potrebno menjati mesta injiciranja.
Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Zdravilo Bortezomib SUN je v kombinaciji z melfalanom in prednizonom indicirano za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v velikih odmerkih ni primerna.
Uncommon Fall, Contusion Rare
- nenormalen, zamegljen vid
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib SUN must be considered unless the benefit of treatment clearly outweighs the risk.
morate premisliti o ukinitvi zdravila Bortezomib SUN, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
How to store Bortezomib SUN
Način dajanja zdravila Bortezomib SUN
Pneumonia*
Syndrome)
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib SUN for information related to these medicines before starting treatment with Bortezomib SUN.
Preden začnete zdravljenje z zdravilom Bortezomib SUN, preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z zdravilom Bortezomib SUN.
Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with bortezomib.
Med zdravljenjem z bortezomibom je treba pogosto spremljati število krvnih celic z diferencialno krvno sliko, vključno s številom trombocitov.
VDDx=vincristine, doxorubicin, dexamethasone; BzmbDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BzmbTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
VDDx=vinkristin, doksorubicin, deksametazon; BzmbDx=bortezomib, deksametazon; TDx=talidomid, deksametazon;
Renal complications are frequent in patients with multiple myeloma.
Pri bolnikih z diseminiranim plazmocitomom so pogosti ledvični zapleti.
Pulmonary disorders
Diseminirani plazmocitom
The vial is contained in a transparent blister pack consisting of a tray with a lid. Each pack contains 1 single-use vial.
Ena škatla vsebuje eno vialo za enkratno uporabo.
Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection* Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Občasni okužba*, bakterijske okužbe*, virusne okužbe*, sepsa (vključno s septičnim šokom)*, bronhopnevmonija, okužba s herpesvirusom*, herpetični meningoencefalitis#, bakteriemija (vključno s stafilokokno), hordeol, gripa, celulitis, z uporabo katetra povezana okužba, okužba
Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Za potrditev varnosti in učinkovitosti uvajalnega zdravljenja z bortezomibom v kombinacijah z dvema ali tremi kemoterapevtskimi učinkovinami, pred presaditvijo krvotvornih matičnih celic pri bolnikih s še nezdravljenim diseminiranim plazmocitomom so izvedli dve randomizirani, odprti, multicentrični preskušanji faze III (IFM-2005-01, MMY-3010).
Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Zelo pogosti zmanjšan apetit Pogosti dehidracija, hipokaliemija*, hiponatriemija*, nenormalne koncentracije glukoze v krvi*, hipokalciemija*, encimske motnje*
Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
hipomagneziemija*, hipofosfatemija*, hiperkaliemija*, hiperkalciemija*, hipernatriemija*, nenormalne koncentracije sečne kisline*, sladkorna bolezen*, zastajanje tekočine
Very common side effects (may affect more than 1 in 10 people) - sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage - reduction in the number of red blood cells and/or white blood cells (see above) - fever - feeling sick (nausea) or vomiting, loss of appetite - constipation with or without bloating (can be severe) - diarrhoea: if this happens, it is important that you drink more water than usual.
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - občutljivost, odrevenelost, mravljinci ali pekoč občutek na koži ali bolečine v dlaneh in stopalih zaradi poškodbe živca - zmanjšanje števila rdečih krvnih celic in/ali belih krvnih celic (glejte zgoraj)
Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS
Redki ušesna krvavitev, vestibularni nevronitis, ušesne bolezni n.d.n.
If you have not been treated before for mantle cell lymphoma you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Limfom plaščnih celic, ki še ni bil zdravljen Če vam limfoma plaščnih celic še niso zdravili, boste zdravilo Bortezomib SUN prejeli v veno, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Zdravilo Bortezomib SUN je v kombinaciji z deksametazonom ali deksametazonom in talidomidom indicirano za indukcijsko zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih.
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 (BzmbR-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.
1,3 mg/m2 telesne površine, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzmbR-CAP), v primerjavi z 242 bolniki, zdravljenimi z rituksimabom,
Class
Izmed
Mild
Viala
Once the symptoms of the toxicity have resolved, Bortezomib SUN treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2).
vendar s 25 % manjšim odmerkom (1,3 mg/m2 zmanjšano na 1,0 mg/m2; 1,0 mg/m2 zmanjšano na
Hypothyroidism
Hipotenzija
Posology modification
Prilagoditev odmerjanja
bleeding of the eye - swelling of your lymph glands - joint or muscle stiffness, sense of heaviness, pain in your groin - hair loss and abnormal hair texture - allergic reactions - redness or pain at the injection site - mouth pain - infections or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestines,
- bolečine v trebuhu, napenjanje - oteženo požiranje - okužba ali vnetje trebuha in črevesja - bolečina v želodcu - vnetje ust ali ustnic, bolečina v žrelu
restlessness or agitation, changes in your mental status, disorientation
- težave s spanjem, znojenje, tesnoba, nihanje razpoloženja, depresivno razpoloženje, nemir ali vznemirjenost, spremembe v duševnem stanju, dezorientiranost
Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses.
V primerjavi s ponovljenimi odmerki se bortezomib po prvem odmerku hitreje izloči iz telesa.
Common Renal impairment*
Pogosti okvara ledvic*
sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood - skin infections - bacterial and viral infections - tooth infection - inflammation of the pancreas, obstruction of the bile duct - genital pain, problem having an erection - weight increase - thirst - hepatitis - injection site or injection device related disorders - skin reactions and disorders (which may be severe and life threatening), skin ulcers - bruises, falls and injuries - inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
- pordelost ali bolečina na mestu injiciranja - bolečine v ustih - okužbe ali vnetja v ustih, razjede v ustih, požiralniku, želodcu in črevesju, ki jih včasih spremlja bolečina ali krvavitev, počasno gibanje črevesja (vključno z zaporo), nelagodje v trebuhu ali požiralniku, oteženo požiranje, bruhanje krvi - okužbe kože - bakterijske in virusne okužbe - okužba zob - vnetje trebušne slinavke, zapora žolčevoda - bolečina v spolovilih, motnje pri doseganju erekcije - zvečanje telesne mase - žeja - vnetje jeter (hepatitis)
• Reconstitution, dosing and administration booklet
• Izobraževalno knjižico z navodili za rekonstitucijo, odmerjanje in način uporabe
1 prior line of therapy
1 predhodna vrsta zdravljenja
- If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl, Bortezomib SUN may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).
≥ 25.000 celic/μl, lahko ponovno uvedete zdravilo Bortezomib SUN v odmerku, ki je za eno stopnjo manjši od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na 0,7 mg/m2).
Incidence Adverse reaction block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Redki atrijska undulacija, miokardni infarkt*, atrioventrikularni blok*, srčnožilne bolezni (vključno s kardiogenim šokom), Torsade de pointes, nestabilna angina pektoris,
Distribution 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.
Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) od 1,659 l do 3,294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Po kriterijih Evropske skupine za transplantacijo kostnega mozga (EBMT - European Group for Blood and Marrow Transplantation) je bil primarni opazovani dogodek glede učinkovitosti TTP, sekundarna opazovana dogodka pa OS in
When Bortezomib SUN is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Pri sočasni uporabi zdravila Bortezomib SUN z drugimi zdravili glejte povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
krvavitev*, tromboflebitis (vključno s površinskim), cirkulatorni kolaps (vključno s hipovolemičnim šokom), flebitis, pordelost*, hematom (vključno s perirenalnim)*, slaba periferna prekrvavitev*, vaskulitis, hiperemija (vključno z očesno)*
Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema in vezivnega tkiva*, sinovialna cista
Common Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
4.1 Terapevtske indikacije Zdravilo Bortezomib SUN je indicirano za zdravljenje diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali deksametazonom pri odraslih bolnikih, ki so prejeli najmanj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev pri njih ni mogoča.
You may also be given Bortezomib SUN together with the medicines pegylated liposomal doxorubicin or dexamethasone: - When Bortezomib SUN is given together with pegylated liposomal doxorubicin, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle.
- Če boste prejeli zdravilo Bortezomib SUN skupaj s pegiliranim liposomskim doksorubicinom, vam bodo zdravilo Bortezomib SUN injicirali v veno ali v podkožje v 21-dnevnem krogu zdravljenja in pegilirani liposomski doksorubicin v odmerku 30 mg/m2 v obliki enourne intravenske infuzije na 4. dan 21-dnevnega kroga zdravljenja, po injekciji zdravila Bortezomib SUN.
Dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib SUN 21-day treatment cycle.
Bolnik jemlje 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan 21-dnevnega kroga zdravljenja z zdravilom Bortezomib SUN.
- mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
v kombinaciji z deksametazonom ali z deksametazonom in talidomidom pri bolnikih, pri katerih bolezni še nismo zdravili ter pred kemoterapijo v velikih odmerkih in presaditvijo krvotvornih matičnih celic (uvajalno zdravljenje); - limfoma plaščnih celic (redka oblika raka, ki prizadene bezgavke) pri bolnikih, starih 18 let in več, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom, pri bolnikih, pri katerih bolezni še nismo zdravili in pri katerih presaditev krvotvornih matičnih celic ni primerna.
Uncommon side effects (may affect up to 1 in 100 people) - heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate - failing of your kidneys - inflammation of a vein, blood clots in your veins and lungs - problems with blood clotting - insufficient circulation - inflammation of the lining around your heart or fluid around your heart - infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis - bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina - cerebrovascular disorders - paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
- vnetje srčne ovojnice ali nabiranje tekočine okoli srca - okužbe, vključno z okužbo sečil, gripa, okužba s herpes virusom, ušesne okužbe in celulitis - krvavo blato, krvavitve iz sluznic, npr. v ustih, nožnici - možganskožilne bolezni - paraliza, krči, padci, motnje gibanja, nenormalen, spremenjen ali zmanjšan občutek (otip, sluh,
Overall survival* Events (deaths) n (%) Mediana (95% CI)
Preživetje brez napredovanja bolezni dogodki n (%) medianaa (95 % CI)
There have been fatal cases of inadvertent intrathecal administration of bortezomib.
Intratekalna uporaba Nenamerno intratekalno dajanje bortezomiba se je končalo s smrtnimi primeri.
Injection into a vein is rapid, taking 3 to 5 seconds.
traja od 3 do 5 sekund.
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
(npr. bortezomib v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo bortezomib) po parih tako, da na podlagi nerandomiziranih podatkov izločimo moteče dejavnike, ki lahko vplivajo na oceno učinkov zdravljenja.
Posology for previously untreated multiple myeloma patients eligible for haematopoietic stem cell transplantation (induction therapy)
Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in so primerni za presaditev krvotvornih matičnih celic (uvajalno zdravljenje)
SGOT (AST) levels Modification of starting dose
Koncentracija SGOT (AST)
Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm.
Diseminirani plazmocitom V Bzmb+M+P kraku študije je protivirusna zdravila prejelo 26 % bolnikov.
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)#, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
hiperviskozni sindrom, bolezni trombocitov n.d.n., trombotična mikroangiopatija (vključno s trombocitopenično purpuro)#, bolezni krvi n.d.n.,
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#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s clostridium difficile)*, ishemični kolitis#, vnetje prebavil*, disfagija, sindrom razdražljivega črevesja, bolezni prebavil n.d.n., obložen jezik, motnje črevesne motilitete*, motnje v delovanju žlez slinavk*
chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse - movement disorders, paralysis, twitching - vertigo - hearing loss, deafness - disorders that affect your lungs, preventing your body from getting enough oxygen.
bolečino ali tiščanje v prsih in/ali omotico/omedlevico, hudo srbenje kože ali dvignjene bulice na koži, otekanje obraza, ustnic, jezika in/ali grla, kar lahko povzroči oteženo požiranje, kolaps
Elderly
huda
Skin reaction, Jessner's lymphocytic infiltration, Palmarplantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
sindrom palmarno-plantarne eritrodisestezije, podkožne krvavitve, livedo retikularis, zatrdlina kože, papule,
Bortezomib subcutaneous arm
Redki draženje sečnega mehurja
No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Pri dodatku zdravila bortezomib standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
Bortezomib SUN 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.
Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21-dnevnem krogu zdravljenja.