natgillin/translations-raw huggingface dataset:
In order to provide further evidence of efficacy and safety of polatuzumab vedotin in DLBCL, the MAH will provide Study GO39942, a randomized, double-blind, placebo controlled trial that evaluates polatuzumab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) versus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma.
GO39942: randomizirano, dvojno slepo, s placebom kontrolirano preskušanje, ki ocenjuje polatuzumab vedotin v kombinaciji z R-CHP (rituksimab, ciklofosfamid,
Pharmacotherapeutic group: antineoplastic agents; other antineoplastic agents; monoclonal antibodies ATC code: L01XC37
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), drugi pripravki za zdravljenje novotvorb, monoklonska protitelesa.
Table 3: Polivy, bendamustine and rituximab dose modifications for Infusion-related reactions (IRRs)
Prilagoditve odmerka zdravila Polivy, bendamustina in rituksimaba v primeru reakcij, povezanih z infundiranjem
Polivy is given in combination with two other cancer medicines called rituximab and bendamustine.
Katera druga zdravila uporabljamo z zdravilom Polivy Zdravilo Polivy uporabljamo v kombinaciji z dvema drugima zdraviloma za zdravljenje raka, imenovanima rituksimab in bendamustin.
6.6 Special precautions for disposal and other handling General precautions
6.6 Posebni varnostni ukrepi za odstranjevanje
How Polivy is given
Kako se daje zdravilo Polivy
PML is a very rare and life threatening infection in the brain, that has occured in one patient treated with Polivy together with bendamustine and another medicine called obinutuzumab.
PML je zelo redka in življenje ogrožajoča okužba v možganih, ki se je pojavila pri enem bolniku,
No dedicated teratogenicity studies in animals have been performed with polatuzumab vedotin.
Namenskih študij teratogenosti na živalih s polatuzumabom vedotinom niso izvedli.
Table 2 Polivy, bendamustine and rituximab dose modifications for myelosuppression Severity of myelosuppression on
Prilagoditve odmerka zdravila Polivy, bendamustina in rituksimaba v primeru mielosupresije
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
79639 Grenzach-Wyhlen Nemčija
What Polivy contains
Kaj vsebuje zdravilo Polivy
The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
Medsebojna delovanja rituksimaba in bendamustina v kombinaciji s polatuzumabom vedotinom Sočasna uporaba polatuzumaba vedotina ne vpliva na farmakokinetiko rituksimaba in bendamustina.
Thrombocytopenia events led to discontinuation of treatment in 11.1% of patients in the Polivy plus BR arm and 5.1% of patients in the BR arm. No patients discontinued treatment due to anaemia in either the Polivy plus BR arm or BR arm.
Zaradi nevtropenije so zdravljenje ukinili pri 8,9 % bolnikov v skupini, zdravljeni z zdravilom Polivy in BR, ter 2,6 % bolnikov v skupini, zdravljeni z BR. Zaradi trombocitopenije je bilo treba ukiniti zdravljenje pri 11,1 % bolnikov v skupini, zdravljeni z zdravilom Polivy in BR, ter pri 5,1 % bolnikov v skupini, zdravljeni z BR.
After reconstitution each mL contains 20 mg of polatuzumab vedotin.
Po rekonstituciji en ml vsebuje 20 mg polatuzumaba vedotina.
• difficulty walking
• težko hodite,
• fever or chills
• izpuščaj/koprivnica
Systemic exposure (AUC) in rats at a dose of 0.2 mg/kg MMAE is approximately 50% of the AUC in patients who received the recommended dose of 1.8 mg/kg Polivy every 21-days.
50 % AUC pri bolnikih, ki so prejemali priporočeni odmerek zdravila Polivy, to je 1,8 mg/kg vsakih
Women of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 9 months after the last dose.
Ženskam v rodni dobi je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem s polatuzumabom vedotinom in vsaj še 9 mesecev po zadnjem odmerku polatuzumaba vedotina.
Polatuzumab vedotin did not prolong the mean QTc interval to any clinically relevant extent based on ECG data from two open-label studies in patients with previously treated B-cell malignancies at the recommended dosage.
Na podlagi elektrokardiografskih podatkov iz dveh odprtih študij pri bolnikih s predhodno zdravljenimi malignomi celic B polatuzumab vedotin v priporočenih odmerkih ni klinično pomembno podaljšal povprečnega intervala QTc.
Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with polatuzumab vedotin and for at least 6 months after the last dose.
Moškim, ki imajo partnerke v rodni dobi, je treba svetovati, naj uporabljajo učinkovito kontracepcijo med zdravljenjem s polatuzumabom vedotinom in vsaj še 6 mesecev po zadnjem odmerku polatuzumaba vedotina.
After reconstitution each millilitre (mL) contains 20 mg polatuzumab vedotin.
Po pripravi vsebuje en mililiter (ml) 20 mg polatuzumaba vedotina.
Patients should be monitored closely for TLS during treatment with Polivy.
Bolnike je treba med zdravljenjem z zdravilom
• a burning sensation
• siljenje na bruhanje
No adjustment in the starting dose is required when administering Polivy to patients with mild hepatic impairment (bilirubin greater than ULN to less than or equal to 1.5 × ULN or aspartate transaminase [AST] greater than ULN).
Bolnikom z blago okvaro jeter (vrednost bilirubina večja od ZNM in manjša ali enaka 1,5-kratni ZNM
Polivy 140 mg powder for concentrate for solution for infusion polatuzumab vedotin
Polivy 140 mg prašek za koncentrat za raztopino za infundiranje polatuzumab vedotin
What Polivy is
Kaj je zdravilo Polivy
Based on the mechanism of action and nonclinical studies, polatuzumab vedotin can be harmful to the foetus when administered to a pregnant woman.
Glede na mehanizem delovanja in rezultate predkliničnih študij lahko pri nosečnici uporabljeni polatuzumab vedotin škoduje plodu.
It is given into a vein, as a drip over 90 minutes.
Zdravilo boste dobili v veno v obliki 90-minutne infuzije (kapalne).
Polivy and any concomitant chemotherapy should be discontinued in patients who develop serious infections.
Pri bolnikih, pri katerih se pojavijo resne okužbe, je treba ukiniti zdravilo Polivy in sočasno kemoterapijo.
Per studied population in mild hepatic impairment (defined as AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN), there was a 40% increase in unconjugated MMAE exposure, which was not deemed clinically significant.
(Pri proučevani populaciji z blago jetrno okvaro (opredeljeno z vrednostjo AST ali ALT > 1,0 in manjšo od 2,5-kratne ZNM, ali vrednostjo celokupnega bilirubina > 1,0 in manjšo od 1,5-kratne ZNM)
Grade 3-4 Thrombocytopenia
CYP3A4 in zaviralci P-gp
One patient (2.2%) in the Polivy plus BR arm discontinued treatment due to infection compared to 5.1% of patients in the BR arm.
V skupini, zdravljeni z zdravilom Polivy in BR, so zdravljenje zaradi okužbe ukinili pri enem bolniku (2,2 %), v skupini,
Musculoskeletal disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva
These are a type of blood cells.
kar odkrijemo na preiskavah krvi.
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.
Polatuzumab vedotin je proti CD79b usmerjen konjugat protitelesa in zdravila, ki prednostno prenese močno antimitotično snov (monometil-avristatin E [MMAE]) do celic B; to povzroči smrt malignih celic B. Molekulo polatuzumaba vedotina sestavlja MMAE, z razcepljivo povezovalno molekulo kovalentno vezan na humanizirano imunoglobulinsko monoklonsko protitelo G1.
No dedicated mutagenicity studies have been performed with polatuzumab vedotin.
Namenskih študij mutagenosti s polatuzumabom vedotinom niso izvedli.
• have a fever
• prehlad
How to store Polivy
Shranjevanje zdravila Polivy
Progressive multifocal leukoencephalopathy (PML) One case of PML, which was fatal, occurred in one patient treated with Polivy plus bendamustine and obinutuzumab.
Pri enem bolniku, zdravljenem z zdravilom Polivy v kombinaciji z bendamustinom in obinutuzumabom, se je pojavil primer PML, ki se je končal s smrtjo.
Diluent used to prepare solution for infusion
Vehikel za pripravo raztopine za infundiranje
If ANC recovers to > 1000/µL on or before Day 7, resume all treatment without any additional dose reductions.
7. dne, nadaljujte celotno zdravljenje brez dodatnega zmanjšanja odmerkov.
Inspect the reconstituted solution for discoloration and particulate matter.
Rekonstituirano raztopino preglejte, da ni spremenjene barve in da ne vsebuje delcev.
6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Sukcinska kislina
Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
Zdravilo Polivy je zdravilo proti raku, ki vsebuje učinkovino polatuzumab vedotin.
PN reported with treatment with Polivy is predominantly sensory PN.
Periferna nevropatija, o kateri so poročali med zdravljenjem z zdravilom Polivy, je bila v glavnem senzorična periferna nevropatija, vendar obstajajo tudi poročila o motorični in senzorimotorični periferni nevropatiji.
In most cases you will not have any symptoms but tell your doctor or nurse straight away if you get: • yellowing of your skin and of the whites of your eyes (jaundice).
Večinoma to ne povzroči simptomov, vendar morate zdravnika ali medicinsko sestro nemudoma obvestiti, če se pri vas pojavi:
There are insufficient data to assess the impact of moderate hepatic impairment (total bilirubin > 1.5-3×ULN, n = 2) on PK. No data are available in patients with severe hepatic impairment or liver transplantation.
Za oceno vpliva zmerne okvare jeter (vrednost celokupnega bilirubina > 1,5- do 3-kratna ZNM, n = 2)
Table 1 Polivy dose modifications for peripheral neuropathy (PN) Severity of PN on
Prilagoditve odmerka zdravila Polivy v primeru pojava periferne nevropatije
• infusion-related reactions
• hujšanje • z infundiranjem povezane reakcije
• numbness
Nevtropenija
p-value (Log-Rank test, stratified***) Overall Response Rate* (INV-assessed) at End of Treatment** Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Complete Response (%) (CR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Partial Response (%) (PR) 95% CI Clopper-Pearson Best Overall Response Rate* (INV-assessed) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] Complete Response (%) (CR) 95% CI Clopper-Pearson Partial Response (%) (PR) 95% CI Clopper-Pearson
95-% Clopper-Pearsonov IZ Najboljši celokupni odgovor*(po raziskovalčevi oceni) Odzivni bolniki (%) (CR, PR)
8.9% of patients in the Polivy plus BR arm discontinued Polivy due to neutropenia compared to 2.6% of patients in the BR arm who discontinued treatment due to neutropenia.
Zaradi periferne nevropatije so pri 2,2 % bolnikov ukinili zdravljenje z zdravilom Polivy, pri
Respiratory, thoracic and mediastinal disorders Very common cough Common pneumonitis
Bolezni dihal, prsnega koša in mediastinalnega prostora
Women
Moški
No dedicated fertility studies in animals have been performed with polatuzumab vedotin.
Namenskih študij vpliva na plodnost na živalih s polatuzumabom vedotinom niso izvedli.
Common pancytopenia
Rekonstituirana raztopina
Table 5 Summary of efficacy in patients with previously treated DLBCL from study GO29365 Polivy + bendamustine + rituximab N = 40
Zdravilo Polivy + bendamustin + rituksimab n = 40
• abdominal (belly) pain
• pomanjkanje apetita • srbenje
Eye disorders Common vision blurred
Pogosti zamegljen vid
Patients were randomized 1:1 to receive Polivy plus BR or BR alone for six 21-day cycles.
Med 80 bolniki, randomiziranimi na prejemanje zdravila Polivy in BR (n = 40) ali kombinacije BR
If possible, the first dose should be given before this season starts.
Če je možno, je treba prvi odmerek dati pred začetkom tveganega obdobja.
It is used in the following groups of children, who are at high risk for this disease:
Uporablja se pri naslednjih skupinah otrok, ki jih takšna bolezen zelo ogroža:
In children born with heart disease, there was a reduction of 45%.
Pri otrocih s prirojenimi boleznimi srca je bilo zmanjšanje 45-odstotno.
Patients generally receive a total of five monthly injections into the thigh muscle.
Bolniki običajno prejmejo pet mesečnih injekcij v stegensko mišico.
The European Commission granted a marketing authorisation valid throughout the European Union for Synagis on 13 August 1999.
Evropska komisija je dovoljenje za promet z zdravilom Synagis, veljavno po vsej Evropski uniji, izdala 13. avgusta 1999.
• children who are less than two years of age and were born with a serious heart disease.
• pri otrocih, mlajših od dveh let, ki so se rodili s hudo boleznijo srca.
The full EPAR for Synagis 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 Synagis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This helps to prevent RSV infection.
Zdravilo na ta način pomaga preprečiti okužbo z RSV.
This is a summary of the European public assessment report (EPAR) for Synagis.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Synagis.
When palivizumab is attached to this protein, the virus becomes unable to enter the body's cells, especially those in the lungs.
Ko se palivizumab veže na ta protein, virus ne more več vstopiti v telesne celice, še zlasti ne v pljučne celice.
This was a reduction of 55%.
To pomeni 55-odstotno zmanjšanje števila hospitalizacij.
For more information about treatment with Synagis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Synagis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
• children who are less than six months old and were born five or more weeks prematurely (at 35
• pri otrocih, mlajših od šest mesecev, ki so se rodili pet ali več tednov prezgodaj (s 35 tedni gestacijske starosti ali manj);
• children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
• pri otrocih, mlajših od dveh let, ki so se v zadnjih šestih mesecih zdravili zaradi bronhopulmonalne displazije (nenormalnega pljučnega tkiva, ki se navadno pojavi pri prezgodaj rojenih otrocih);
Palivizumab has been designed to attach to a protein called ‘fusion protein A' on the surface of RSV.
Palivizumab je zasnovan tako, da se veže na beljakovino imenovano „fuzijski protein A“ na površini RSV.
The CHMP decided that Synagis's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Synagis večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Other information about Synagis
Druge informacije o zdravilu Synagis
Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation.
Zdravilo Synagis se uporablja za preprečevanje hude bolezni spodnjih dihal (pljuč), ki jo povzroča respiratorni sincicijski virus (RSV) in zahteva hospitalizacijo.
Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April.
Zdravilo Synagis se daje enkrat mesečno, če v otrokovem okolju obstaja nevarnost za okužbo z RSV: na področju severne poloble traja obdobje tveganja od novembra do aprila.
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 Synagis.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Synagis, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease.
V drugi opravljeni študiji so zdravilo Synagis primerjali s placebom pri 1 287 otrocih s prirojenimi boleznimi srca.
Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo.
Zdravilo Synagis je bilo pri zmanjšanju števila hospitalizacij zaradi RSV učinkovitejše od placeba: v času trajanja študije so v bolnišnico zaradi okužbe z RSV sprejeli 5 % otrok, ki so prejemali zdravilo Synagis, v primerjavi z 11 % otrok, ki so prejemali placebo.
What benefit has Synagis shown during the studies?
Kakšne koristi je zdravilo Synagis izkazalo med študijami?
The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are fever and rash.
Najpogostejša neželena učinka zdravila Synagis (opažena pri 1 do 10 bolnikih od 100) sta povišana telesna temperatura in izpuščaj.
Synagis must not be used in people who are hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised' monoclonal antibodies.
Zdravila Synagis ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) palivizumab, katero koli drugo sestavino zdravila ali druge vrste humaniziranih monoklonskih protiteles.
It contains the active substance palivizumab.
Vsebuje zdravilno učinkovino palivizumab.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen).
To je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen), ki se nahaja v telesu, in se veže nanjo.
For the full list of all side effects reported with Synagis, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Synagis, glejte navodilo za uporabo.
Synagis is a powder and solvent that are made up into a solution for injection.
Zdravilo Synagis je prašek in vehikel za pripravo raztopine za injiciranje.
What is the risk associated with Synagis?
Kakšna tveganja so povezana z zdravilom Synagis?
Why has Synagis been approved?
Zakaj je bilo zdravilo Synagis odobreno?
The active substance in Synagis, palivizumab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Synagis, palivizumab, je monoklonsko protitelo.
The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season.
V glavni študiji zdravila Synagis, ki so jo izvedli pri 1 502 otrocih z visokim tveganjem za okužbo, so učinkovitost tega zdravila primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine) v obdobju ene sezone razsajanja RSV.
In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.The effects of Synagis were first tested in experimental models before being studied in humans.
V obeh študijah je bilo glavno merilo učinkovitosti število otrok, ki so jih sprejeli v bolnišnico zaradi okužbe z RSV.
How does Synagis work?
Kako zdravilo Synagis deluje?
What is Synagis?
Kaj je zdravilo Synagis?
What is Synagis used for?
Za kaj se zdravilo Synagis uporablja?
How has Synagis been studied?
Kako je bilo zdravilo Synagis raziskano?
How is Synagis used?
Kako se zdravilo Synagis uporablja?
Extension Study 044
Podaljšanje študije 044
Some solution will remain in the vial:
Nekaj raztopine bo ostalo v viali:
There are also links to other websites about rare diseases and treatments.
kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
- You may be given additional medicines to treat or help prevent future reactions.
- Mogoče boste dobili dodatna zdravila za zdravljenje ali preprečevanje prihodnjih reakcij.
The results are presented in Table 2.
Rezultati so predstavljeni v preglednici 2.
An IRR often appears as a hypersensitivity reaction.
IRR se pogosto pojavi kot preobčutljivostna reakcija.
There are 5 potential N-linked glycosylation sites, four of which are occupied.
Obstaja pet potencialnih N-vezavnih glikozilacijskih mest, od katerih so štiri zasedena.
Dose adjustments can be made on an individual basis based on achievement and maintenance of therapeutic goals.
Prilagoditve odmerka se lahko izvedejo za vsakega posameznika posebej na podlagi doseganja in vzdrževanja terapevtskih ciljev.
From a microbiological point of view, the medicine should be used immediately.
Z mikrobiološkega stališča je treba zdravilo porabiti takoj.
However, no data are available for children under the age of 4 years.
Vendar o otrocih, mlajših od 4 let, ni podatkov.
• Patient evaluation and selection;
• ovrednotenje in izbira bolnikov;
In some cases vomiting can be serious (reported from post-marketing experience).
V nekaterih primerih je lahko bruhanje resno (o tem so poročali v obdobju trženja).
400 Units
400 enot
Date of first authorisation: 26 August 2010 Date of latest renewal: 19 June 2015
Datum zadnjega podaljšanja: 19. junij 2015
The majority of hypersensitivity reactions usually occur up to 12 hours post infusion.
Večina preobčutljivostnih reakcij se navadno pojavi do 12 ur po infuziji.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not exceed 24 hours at 2C to 8C.
Če se ne porabi takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo, ti pa ne bi smeli trajati dlje kot 24 ur pri temperaturi od 2 °C do 8 °C.
The effect on height was assessed in the study 044 (see section 5.1, Extension Study 044).
V študiji 044 so ocenili učinek na višino (glejte poglavje 5.1, Podaljšanje študije 044).
VPRIV should not be used in children under the age of 2 years.
Zdravilo VPRIV se ne sme uporabljati pri otrocih, mlajših od 2 let.
• Infusion diary;
• dnevnik infuzij;
Read all of this leaflet carefully before this medicine is used because it contains important information for you.
Pred uporabo zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The calculated volume of medicinal product is withdrawn from the appropriate number of vials.
Odvzemite izračunan volumen zdravila iz ustreznega števila vial.
• Requirements for home infusion (home condition, patient assessment, emergency treatment);
• zahteve za infuzije na domu (pogoji v domačem okolju, ocena bolnika, urgentno zdravljenje);
Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Predhodno zdravljenje z antihistaminiki in/ali kortikosteroidi lahko prepreči poznejše reakcije, če je bilo potrebno simptomatsko zdravljenje.
The studies allowed the inclusion of patients 2 years and older and the safety and efficacy profiles are expected to be similar down to the age of 2 years.
Študije so omogočale vključitev bolnikov, starih 2 leti in več, za profila varnosti in učinkovitosti pa se pričakuje, da bosta podobna pri bolnikih, starih od 2 let naprej.
Use aseptic technique.
Uporabite aseptično tehniko.
Home administration under the supervision of a healthcare professional may be considered only for those patients who have received at least three infusions and were tolerating their infusions well.
O možnosti uporabe doma pod nadzorom zdravstvenega delavca lahko razmišljamo samo pri bolnikih, ki so prejeli vsaj tri infuzije in ki dobro prenašajo infundiranje.
In contrast, no significant change in femoral neck BMD was observed.
V nasprotju s tem niso opazili nobene pomembne spremembe v BMD stegneničnega vratu.
Response to treatment
Odziv na zdravljenje
• Safety information;
• podatki o varnosti;
*Liver and spleen volume is normalized as a percentage of body weight.
*Prostornina jeter in vranice je normalizirana kot odstotek telesne mase.