qanastek/EMEA-V3 huggingface dataset:
Median Age (years) Disease Characteristics (%)
irkadaw wara kura fludarabin li ma irkadaw wara kura b’ kimoterapija ħadimx b’ fludarabin konvenzjonali Età Medjana (snin) Karatteristiċi tal- Marda (%)
Rai Stage III/ IV B Symptoms Prior Therapies (%):
Stadju Rai III/ IV Sintomi B
Alkylating Agents
Alkylating Agents
Number of Prior Regimens (range)
Fludarabine Numru ta ’ Korsijiet ta ’ Qabel (firxa)
Initial Dosing Regimen
Kors ta ’ Dożaġġ Inizjali
Gradual escalation Gradual escalation
Żjieda gradwali minn Żjieda gradwali minn
Gradual escalation
Żjieda gradwali
from 3 to 10 to 30 mg
10 sa 30 mg 10 sa 30 mg
from 10 to 30 mg
minn 10 sa 30 mg
from 10 to 30 mg
Kors ta ’ Dożagg Finali Rata ta ’ Rispons Globali
Final Dosing Regimen Overall Response Rate (%)
30 mg iv 3 x fil - 30 mg iv 3 x fil - ġimgħa ġimgħa 33 21
3 x weekly 30 mg iv 33
mg iv 3 x fil - ġimgħa 29
3 x weekly 21
31 21
30 mg iv 3 x weekly 29
29
(95% Confidence Interval)
(xhur) (95% Intervall ta ’ kunfidenza)
(23-43) 2 31 7 (5-8) 2 (1-2) 4 (3-5)
(5- 8) (5- 23)
(8-33) 0 21 7 (5-23) 4 (1-5) 5 (3-7)
(6- 19)
(11-47) 0 29 11 (6-19) 4 (2-4) 7 (3-9)
Żmien Medju sa Rispons (xhur) (95% Intervall ta ’ kunfidenza)
All patients
2 4 (1- 2) (1- 5)
16 (12-22)
4 (2- 4)
26 (12-44)
Sopravivenza mingħajr
Responders = not reached
(95% Intervall ta '
33 (26-NR)
(3- 5) (3- 7)
44 (28-NR)
(3- 9)
36 (19-NR)
28 (7- 33) 36 (19- NR)
Pharmacokinetics were characterised in MabCampath-naive patients with B-cell chronic lymphocytic leukaemia (B-CLL) who had failed previous therapy with purine analogues.
Il- farmakokinetika kienet ikkaratterizzata f’ pazjenti li qatt ma ħadu MabCampath qabel li kellhom lewkimja limfoċita kronika taċ- ċellula B (B- CLL) li kienu rċevew terapija minn qabel b’ analogi purini li ma ħadmitx.
MabCampath was administered as a 2 hour intravenous infusion, at the recommended dosing schedule, starting at 3 mg and increasing to 30 mg, 3 times weekly, for up to 12 weeks.
MabCampath kien mogħti bħala infużjoni fil- vini fuq perijodu ta ’ sagħtejn, fl- iskeda ta ’ doża rrakkomandata, li bdiet bi 3 mg u żdidet sa 30 mg, 3 darbiet fil- ġimgħa, sa 12- il ġimgħa.
MabCampath pharmacokinetics followed a 2-compartment model and displayed non-linear elimination kinetics.
Il - farmakokinetika ta ’ MabCampath segwiet mudell b’ 2 kompartamenti u wriet kinetiċi ta ’ eliminazzjoni li mhumiex lineari.
After the last 30 mg dose, the median volume of distribution at steady-state was 0.15 l/ kg (range:
Wara l- aħħar doża ta ’ 30 mg, il- volum medjan ta ’ distribuzzjoni fi stat fiss kien ta ’
0.1-0.4 l/ kg), indicating that distribution was primarily to the extracellular fluid and plasma compartments.
0. 1 - 0. 4 l/ kg), li jindika li d- distribuzzjoni kienet primarjament fil- kompartamenti ta ’ fluwidu extra- ċellulari u tal- plażma.
Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i. e. loss of CD52 receptors in the periphery).
Ir- rata ta 'tneħħija sistematika naqset b’ għoti ripetut minħabba tnaqqis fit- tneħħija medjata mir- riċetturi (i. e. telf ta ’ riċetturi CD52 fil- periferiji).
With repeated administration and consequent plasma concentration accumulation, the rate of elimination approached zero-order kinetics.
B’ għoti ripetut u konsegwentement akkumulazzjoni fil- konċentrazzjoni tal- plażma, ir- rata ta ’ eliminazzjoni resqet lejn kinetika zero- order.
As such, half-life was 8 hours (range:
B’ hekk, il- half- life kienet ta ’ 8 sigħat (firxa:
2-32 hours) after the first 30 mg dose and was 6 days (range:
2- 32 siegħa) wara l- ewwel doża ta ’ 30 mg u kienet ta ’ 6 ijiem (firxa:
1-14 days) after the last 30 mg dose.
1- 14- il ġurnata) wara l- aħħar doża ta ’ 30 mg.
Steady-state concentrations were reached after about 6 weeks of dosing.
Konċentrazzjonijiet fi stat fiss ġew milħuqa wara madwar 6 ġimgħat ta ’ dożaġġ.
No apparent difference in pharmacokinetics between males and females was observed nor was any apparent age effect observed.
Ma kienet osservata l- ebda differenza evidenti fil- farmakokinetika bejn l- irġiel u n- nisa u lanqas ma ġie osservat xi effett evidenti minħabba l- età.
Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of the lack of expression of the CD52 antigen on non-primate species.
Evalwazzjoni ta ’ qabel l- użu kliniku ta ’ alemtużumab f’ annimali kienet ristretta għal xadini cynomolgus minħabba n- nuqqas ta ’ l- espressjoni ta 'l- antiġen CD52 fi speċi li mhumiex primati.
Lymphocytopenia was the most common treatment-related effect in this species.
Limfoċitopenija kienet l- aktar effett komuni relatat mal- kura f’ din l- ispeċi.
A slight cumulative effect on the degree of lymphocyte depletion was seen in repeated dose studies compared to single dose studies.
Effett kemmxejn kumulattiv fuq il- grad ta ’ tnaqqis fil- limfoċiti ntwera f’ diversi studji b’ dożi ripetuti meta mqabbel ma ’ studji b’ doża waħda.
Lymphocyte depletion was rapidly reversible after cessation of dosing.
It- tnaqqis fil- limfoċiti kien riversibbli malajr wara il- waqfien tad- dożaġġ.
Reversible neutropenia was seen following daily intravenous or subcutaneous dosing for 30 days, but not following single doses or daily dosing for 14 days.
Newtropenija riversibbli kienet osservata wara doża kuljum fil- vini jew taħt il- ġilda għal 30 ġurnata, imma mhux wara dożi waħdiena jew doża kuljum għal 14- il ġurnata.
Histopathology results from bone marrow samples revealed no remarkable changes attributable to treatment.
Riżultati istopatoloġiċi minn kampjuni tal- mudullun ma wrew l- ebda bidla partikolari minħabba l- kura.
Single intravenous doses of 10 and 30 mg/ kg produced moderate to severe dose related hypotension accompanied by a slight tachycardia.
Dożi waħdiena fil- vini ta ’ 10 u 30 mg/ kg ikkaġunaw pressjoni baxxa moderata sa severa relatata mad- doża flimkien ma ’ takikardija ħafifa.
MabCampath Fab binding was observed in lymphoid tissues and the mononuclear phagocyte system.
Irbit ta ’ MabCampath ma ’ Fab kien osservat f’ tessuti limfatiċi u fis- sistema fagoċita mononukleari.
Significant Fab binding was also observed in the male reproductive tract (epididymis, sperm, seminal vesicle) and the skin.
Irbit sinifikanti ma ’ Fab kien osservat ukoll fl- apparat riproduttiv maskili (epididimis, sperma, bużżieqa seminali) u l- ġilda.
No other findings, in the above toxicity studies, provide information of significant relevance to clinical use.
Fl- istudji tossoloġiċi ta ’ fuq, l- ebda sejba oħra ma tipprovdi nformazzjoni ta ’ rilevanza sinifikanti għal użu kliniku.
14 No short or long term animal studies have been conducted with MabCampath to assess carcinogenic and mutagenic potential.
Ma sarux studji ta ’ perijodu ta 'żmien qasir jew twil fuq l- annimali b' MabCampath sabiex jiġi stmat il - potenzjal karċinoġeniku u mutaġeniku.
Disodium edetate Polysorbate 80 Potassium chloride Potassium dihydrogen phosphate Sodium chloride Dibasic sodium phosphate Water for injections
Disodium edetate Polysorbate 80
There are no known incompatibilities with other medicinal products.
Mhux magħruf li jeżistu inkompatibilitajiet ma ’ prodotti mediċinali oħrajn.
However, other medicinal products should not be added to the MabCampath infusion or simultaneously infused through the same intravenous line.
Madankollu, prodotti mediċinali oħra m' għandhomx jitħaltu ma 'l- infużjoni ta ’ MabCampath jew jiġu infużi fl- istess waqt mill- istess pajp għal ġol- vina.
6.3 Shelf life
16 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
MabCampath contains no antimicrobial preservative.
MabCampath ma fih l- ebda preservattiv kontra l- mikrobi.
MabCampath should be used within 8 hours after dilution.
MabCampath għandu jintuża fi żmien 8 sigħat wara li jkun ġie dilwit.
Solutions may be stored at 15°C-30°C or refrigerated.
Is- soluzzjonijiet jistgħu jinħażnu f’ temperatura ta ’ 15°C - 30°C jew fil- friġġ.
This can only be accepted if preparation of the solution takes place under strictly aseptic conditions and the solution is protected from light.
Dan jista ’ jiġi aċċettat biss jekk il- preparament tas- soluzzjoni ssir taħt kondizzjonijiet strettament asettiċi u s- soluzzjoni tkun imħarsa mid- dawl.
5ml ampoule (clear Type I glass) containing 3 ml of concentrate.
Ampulla ta '5ml (ħġieġ ċar ta' Tip I) li fiha 3 ml ta ’ konċentrat.
Pack size: carton of 3 ampoules.
Daqs tal- pakkett: kartuna bi 3 ampulli.
The ampoule contents should be inspected for particulate matter and discolouration prior to administration.
Il- kontenut tal- ampulla għandu jiġi spezzjonat għal frak żgħir u għal tibdil fil- kulur qabel ma jingħata.
If particulate matter is present or the concentrate is coloured, then the ampoule should not be used.
Jekk hemm xi frak jew il- konċentrat huwa kulurit, l- ampulla m' għandiex tintuża.
MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light.
MabCampath ma fihx preservattivi kontra l- mikrobi, u għalhekk huwa rrakkomandat li MabCampath jiġi ppreparat għall- infużjoni fil- vini permezz ta ’ teknika asettika u li s- soluzzjoni għall- infużjoni tiġi mogħtija fi żmien 8 sigħat wara l- preparazzjoni u mħarsa mid- dawl.
The 15 required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μ m filter, to 100 ml of sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
L- ammont meħtieġ tal- kontenut tal- ampulla għandu jiġi miżjud ma ’ 100 ml ta ’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew ta ’ glucose (5%), permezz ta ’ filtru sterili ta ’ 5 µm, li mhux tal- fibra u li ma tantx jorbot proteini.
The bag should be inverted gently to mix the solution.
Il- borża għandha tiġi maqluba bil- mod ta ’ taħt fuq sabiex titħallat is- soluzzjoni.
Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Għandha tingħata attenzjoni sabiex tiġi żgurata l- isterilità tas- soluzzjoni ppreparata peress li ma fiha l- ebda preservattiv kontra l- mikrobi.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line.
Prodotti mediċinali oħra m' għandhomx jiġu miżjuda mas- soluzzjoni għall- infużjoni ta ’ MabCampath u m’ għandhomx jiġu infużi fl- istess waqt mill- istess pajp għal ġol- vina.
Caution should be exercised in the handling and preparation of the MabCampath solution.
Għandu jkun hemm kawtela waqt l- immaniġġjar u l- preparazzjoni tas- soluzzjoni ta ’ MabCampath.
The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the ampoule or other accidental spillage.
Huwa rrakkomandat l- użu ta ’ ingwanti tal- latex u nuċċalijiet tas- sigurtà sabiex jiġi evitat esponiment f’ każ ta ’ ksur ta ’ l- ampulla jew tixrid aċċidentali ieħor.
Women who are pregnant or trying to become pregnant should not handle MabCampath.
Nisa li huma tqal jew li qed jippruvaw joħorġu tqal m’ għandhomx jimmanniġġjaw MabCampath.
Procedures for proper handling and disposal should be observed.
Għandhom jiġu osservati proċeduri xierqa għall- immaniġġjar u r- rimi.
Any spillage or waste material should be disposed of by incineration.
Kull tixrid jew materjal ta ’ skart għandu jiġi mormi permezz ta 'inċinerazzjoni.
Genzyme Europe BV Gooimeer 10 1411 DD Naarden Netherlands
Genzyme Europe BV Gooimeer 10 1411 DD Naarden L- Olanda
06/ 07/ 2001 Date of latest renewal:
06/ 07/ 2001 Data ta 'l- aħħar tiġdid:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
MabCampath 30 mg/ ml concentrate for solution for infusion
MabCampath 30 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
One ml contains 30 mg of alemtuzumab.
1ml fih 30 mg ta ’ Alemtuzumab.
Each vial contains 30 mg of alemtuzumab.
Kull ampulla fiha 30mg ta ’ alemtuzumab
Colourless to slightly yellow concentrate.
Konċentrat bla ebda kulur sa kemmxejn isfar.
Antibiotics and antivirals should be administered routinely to all patients throughout and following treatment (see section 4.4).
Antibijotiċi u antivirali għandhom jingħataw lill- pazjenti kollha bħala rutina matul u wara l- kura (ara sezzjoni 4. 4).
Thereafter, the recommended dose is 30 mg daily administered 3 times weekly on alternate days up to a maximum of 12 weeks.
Minn hemm il - quddiem, id- doża rrakkomandata hija ta ’ 30 mg kuljum, li tingħata tliet darbiet fil - ġimgħa, ġurnata iva, ġurnata le għal massimu ta ’ 12- il ġimgħa.
However, if acute moderate to severe adverse reactions such as hypotension, rigors, fever, shortness of breath, chills, rashes and bronchospasm (some of which may be due to cytokine release) occur at either the 3 mg or 10 mg dose levels, then those doses should be repeated daily until they are well tolerated before further dose escalation is attempted (see section 4.4).
Madankollu, jekk iseħħu reazzjonijiet avversi akuti ta ’ natura moderata sa severa bħal pressjoni baxxa, tertir, deni, qtugħ ta ’ nifs, sirdat, raxx u bronkospażmu (li wħud minnhom jistgħu jkunu minħabba reħa ta ’ cytokine) fil- livell ta ’ dożaġġ ta ’ 3 mg jew ta ’ 10 mg, dawk id- dożi għandhom jiġu ripetuti kuljum sakemm ikunu ittollerati sew qabel ma tiġi ppruvata doża ogħla (ara sezzjoni 4. 4).
17 Median duration of treatment was 11.7 weeks for first line patients and 9.0 weeks for previously treated patients.
19 Iż- żmien medjan ta ’ kura kien ta ’ 11. 7 ġimgħat għal pazjenti li għalihom din kienet il- kura preferita u 8. 0 ġimgħat għal pazjenti kkurati qabel.
*If the delay between dosing is ≥ 7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg and then to 30 mg as tolerated
* Jekk id- dewmien bejn id- dożaġġ huwa ≥ 7 ġranet, ibda ’ t- terapija b’ MabCampath 3 mg u żid għal 10 mg u wara għal 30 mg skond kif ikun ittollerat
There are no dose modifications recommended for severe lymphopenia given the mechanism of action of MabCampath.
M’ hemm l- ebda modifikazzjonijiet fid- doża rrakkomandati għal limfopenja severa minħabba l - mekkaniżmu t’ azzjoni ta ’ MabCampath.
Children and adolescents (below 17 years of age):
Tfal u adoloxxenti (taħt l- età ta ’ 17- il sena)
18 Patients with renal or hepatic impairment:
20 Pazjenti b 'indeboliment tal- kliewi jew tal- fwied:
No studies have been conducted.
L- ebda studju ma ’ ġie mwettaq.
Acute adverse reactions, which may occur during initial dose escalation and some of which may be due to the release of cytokines, include hypotension, chills/ rigors, fever, shortness of breath and rashes.
Reazzjonijiet avversi akuti li jistgħu jseħħu hekk kif tinbeda doża ogħla u li wħud minnhom jistgħu jkunu minħabba r- reħa ta ’ cytokine, jinkludi pressjoni baxxa, sirdat/ tertir, deni, nuqqas ta ’ nifs u raxx.
Caution should be used in treating patients with ischaemic heart disease, angina and/ or in patients receiving an antihypertensive medicincal product.
Għandu jkun hemm kawtela fil- kura ta ’ pazjenti b’ mard iskemiku tal- qalb, anġina u/ jew f’ pazjenti li qed jirċievu prodott mediċinali kontra l- pressjoni għolja.
It is recommended that patients be premedicated with oral or intravenous steroids 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated.
Huwa rrakkomandat li pazjenti jkunu kkurati minn qabel bi sterojdi orali jew fil- vini 30- 60 minuta qabel kull infużjoni ta ’ MabCampath waqt żjieda fid- doża u kif indikat klinikament.
Because of the potential for Transfusion Associated Graft Versus Host Disease (TAGVHD) it is recommended that patients who have been treated with MabCampath receive irradiated blood products.
21 Minħabba l- possibiltà ta ’ Transfusion Associated Graft Versus Host Disease (TAGVHD), huwa rrakkomandat li pazjenti li kienu ikkurati b’ MabCampath jirċievu prodotti tad- demm irradjati.
19 Asymptomatic laboratory positive Cytomegalovirus (CMV) viraemia should not necessarily be considered a serious infection requiring interruption of therapy.
Viremija kkawżata minn cytomegalovirus (CMV) mhix sintomatika iżdaa pożittiva fil- laboratorju m’ għandhiex bilfors tiġi kkunsidrata bħala infezzjoni serja li teħtieġ li t- terapija tiġi interrotta.
4.6 Pregnancy and lactation
22 4. 7 Tqala u Treddigħ
MabCampath is contraindicated during pregnancy.
MabCampath huwa kontra- indikat waqt it- tqala.
Animal reproduction studies have not been conducted with MabCampath.
Ma sarux studji dwar ir- riproduzzjoni fl - annimali b' MabCampath.
It is 20 not known whether MabCampath can cause foetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
Mhux magħruf jekk MabCampath jistax jikkaġuna ħsara fil- fetu meta jingħata lil nisa tqal jew jekk jistax jaffetwa l- kapaċità riproduttiva.
Approximately 97% of first-line patients experienced adverse reactions; the most commonly reported reactions in first-line patients usually occurred in the first week of therapy.
Madwar 97% tal- pazjenti ikkurati għall- ewwel darba kellhom reazzjonijiet avversi: l- aktar reazzjonijiet irrapportati b’ mod komuni f’ pazjenti ikkurati għall - ewwel darba ġeneralment seħħew fl- ewwel ġimgħa ta ’ terapija.
Within each frequency grouping, undesirable effects observed during treatment or within 30 days following the completion of treatment with MabCampath, are presented in order of decreasing seriousness.
L- effetti li huma l- aktar serji huma mniżżla l- ewwel, segwiti minn dawk anqas serji.
SYSTEM ORGAN CLASS MEDDRA
23 Sistema tal- Klassifika tal- Organi MedDRA
Staphylococcal bacteraemia Tuberculosis Bronchopneumonia Herpes ophthalmicus Beta haemolytic streptococcal infection Candidiasis Genital candidiasis Urinary tract infection Cystitis Body tinea
Batterimja kkawżata minn Staphyloccus Tuberkulosi Bronkopnewmonja Herpes ophthalmicus Infezzjoni emolitika beta kkawżata minn streptococcus Kandidajasi Kandidajasi ġenitali Infezzjoni fl- apparat urinarju Ċistite Tinea tal- ġisem Nasofarinġite Rinite
Orthostatic hypotension Hot flush Flushing
Pressjoni ortostatika baxxa Fwawar ta ’ sħana
Respiratory, thoracic and mediastinal disorders
24 Sistema tal- Klassifika tal- Organi MedDRA
Bronchospasm Dyspnoea
Komuni ħafna
Hypoxia Pleural effusion Dysphonia Rhinorrhoea
Komuni
Gastrointestinal disorders
Mhux komuni Fwawar
Nausea
Disturbi respiratorji, toraċiċi u medjastinali
Vomiting Abdominal pain
Bronkospażmu Qtugħ ta ’ nifs
Ileus Oral discomfort Stomach discomfort Diarrhoea
Ipoksja Effużjoni fil- plewra Disfonija Rinoreja
Skin and subcutaneous tissue disorders
Disturbi gastro - intestinali
Urticaria
Tqalligħ
Dermatitis allergic
Rimettar Uġigħ addominali
Rash pruritic
Ileus Skomdu fil- ħalq Taqlib fl- istonku Dijarea
Rash
Urtikarja Raxx
22
Mijalġja Uġigħ muskolu - skeltrali Uġigħ fid- dahar
Myalgia Musculoskeletal pain Back pain
Uġigħ fl- għadam Artralġja Uġigħ muskolu- skeltrali fis- sider Spażmi fil- muskoli
Bone pain Arthralgia Musculoskeletal chest pain
Disturbi fil- kliewi u fis- sistema urinarja
SYSTEM ORGAN CLASS MEDDRA
Jonqos l- ammont ta ’ awrina Disurja
VERY COMMON
Disturbi ġenerali u kondizzjonijiet ta '
COMMON
Deni
UNCOMMON Muscle spasms
Għeja
Renal and urinary disorders
Infjammazzjoni fil- mukosa
SYSTEM ORGAN CLASS MEDDRA
25 SISTEMA TAL - KLASSIFIKA TAL - ORGANI MEDDRA
UNCOMMON
MHUX KOMUNI Infezzjoni kkawżata minn
Infections and infestations
Infezzjonijiet u
Cytomegalovirus infection
Infezzjoni kkawżata
Bacterial infection
minn Cytomegalovirus
Viral infection
Herpes simplex
Herpes simplex
Larinġite
Pneumonitis Fungal infection Candidiasis Herpes zoster Abscess Urinary tract infection Sinusitis Bronchitis Upper respiratory tract infection Pharyngitis Infection
Kandidajasi Herpes zoster Axxess Infezzjoni fl- apparat urinarju Sinusite Bronkite Infezzjoni fl- apparat respiratorju ta 'fuq Faringite Infezzjoni
Fungal dermatitis Laryngitis Rhinitis Onychomycosis
Rinite Onikomikożi
Neoplasms, benign, malignant and unspecified (incl. cysts and polyps)
Neoplażmi, beninni, malinni u dawk mhux speċifikati (inkluż ċesti u polipi)
Lymphoma – like disorder
Disturbi bħal limfoma
Granulocytopenia Thrombocytopenia
Granuloċitopenija
23
Newtropenija bid - deni
Febrile neutropenia Pancytopenia
Aplasja tal- mudullun tal - għadam
Aplasia bone marrow Disseminated intravascular coagulation
tas- sistema limfatika
Anaemia
Tromboċitopenija
Leukopenia
Panċitopenija
Haemolytic anaemia, Decreased haptoglobin
Koagulazzjoni intravaskulari mifruxa
Lymphopenia
Lewkopenija
Bone marrow depression
Anemija emolitika, Ħaptoglobin imnaqqas
Epistaxis Gingival bleeding Haematology test abnormal
Mudullun imrażżan Epistassi Fsada mill- ħanek Test ematoloġiku mhux normali
Metabolic and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjon
Psychiatric disorders
Depersonalizzazzjoni Disturb fil- personalità
Confusion Anxiety Depression Somnolence Insomnia
Ħsibijiet mhux normali
Depersonalisation Personality disorder Abnormal thinking Impotence Nervousness
26 SISTEMA TAL - KLASSIFIKA TAL - ORGANI MEDDRA
24
Tqalligħ
Gastrointestinal haemorrhage
Stomatite ulċerattiva
Gastroenteritis
Ulceri fl- ilsien
Nausea Diarrhoea
Dijarea
Ulcerative stomatitis Stomatitis Abdominal pain Dyspepsia Constipation Flatulence
Stomatite Uġigħ addominali Dispepsja Stitikezza Gass
Tongue ulceration Gingivitis Hiccup Eructation Dry mouth
Ġinġivite Sulluzzu Tifwiq Ħalq xott
Hepatic function abnormal
Funzjoni epatika mhux normali
Maculo-papular rash
Urtikarja Raxx Iperidrosi
Chest pain Influenza-like symptoms
Mukosite Edima fil- ħalq
Pulmonary oedema Peripheral oedema
Edima periorbitali Ulċerazzjoni fil- mukosa
Fatigue
Edima Astenja
Mucositis Oedema mouth Oedema Asthenia Malaise Temperature change sensation Infusion site reaction Pain
Tbenġil fis- sit ta ’ l- infużjoni Dermatite fis- sit ta ’ l - infużjoni
Periorbital oedema Mucosal ulceration Infusion site bruising Infusion site dermatitis Infusion site pain
Uġigħ fis- sit ta ’ l- infużjoni
Severe anaphylactic and other hypersensitivity reactions, including anaphylactic shock and angioedema, have been reported following MabCampath administration.
Reazzjonijiet anafilattiċi severi u reazzjonijiet ta 'sensittività eċċessiva oħrajn, li jinkludu xokk anafilattiku u anġjoedima ġew irrapportati wara l- għoti ta' MabCampath.
The recommended anti-infective prophylaxis treatment appears to be effective in reducing the risk of PCP and herpes infections (see section 4.4).
Il- kura rakkomandata għal profilassi kontra l- infezzjonijiet tidher li hija effettiva biex tnaqqas ir- riskju ta ’ infezzjonijiet ikkawżati minn PCP u herpes (ara sezzjoni 4. 4).
25 Immune system disorders:
Disturbi fis- sistema immuni:
Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain Barré syndrome and its chronic form, chronic inflammatory demyelinating polyradiculoneuropathy have been reported.
28 Guillain Barré u l- forma kronika tiegħu, u demyelinating polyradiculoneuropathy infjammatorja kronika.
5.1 Pharmacodynamic properties
5. 2 Tagħrif farmakodinamiku
First Line B-CLL Patients
Pazjenti b’ B- CLL ikkurati għall- Ewwel Darba
The safety and efficacy of MabCampath were evaluated in a Phase 3, open-label, randomized comparative trial of first line (previously untreated) Rai stage I-IV B-CLL patients requiring therapy (Study 4).
Is- sigurtà u l- effikaċja ta ’ MabCampath kienu evalwati fi prova ta ’ Fażi 3, open- label, randomised u komparattiva ta ’ pazjenti b’ B- CLL ta ’ Rai stage I- IV kkurati għall- ewwel darba (mhux ikkurati qabel) li kienu jeħtieġu terapija (Studju 4).
Time to Alternative Treatment (Months) K-M median (95% Confidence Interval) *Pearson chi-square test or Exact test ** Duration of best response
(Xhur) K- M medjan (95% Intervall ta ’ Kunfidenza) * Test Pearson chi- square jew test Exact ** It- Tul ta ’ l- aħjar rispons
*** log-rank test stratified by Rai group (Stage I-II **** by 4-colour flow
*** Test log- rank stratifikat skond il- grupp Rai (Stadju I- II vs III- IV) **** b’ influss ta ’ 4- kuluri
27 Cytogenetic Analyses in First Line B-CLL Patients:
Analiżi Ċitoġenika għal Pazjenti b’ B- CLL Ikkurati għall- Ewwel Darba:
The cytogenetic profile of B-CLL has been increasingly recognized as providing important prognostic information and may predict response to certain therapies.
30 Il- profil ċitoġenetiku ta ’ B- CLL qed ikun identifikat dejjem aktar li jagħti informazzjoni prognostika importanti u tista ’ tipprevedi r- rispons ta ’ ċertu terapiji.
Assessment of CMV by PCR:
Analiżi ta ’ CMV permezz ta ’ PCR
Alkylating Agents Fludarabine Number of Prior Regimens (range) Initial Dosing Regimen
Alkylating Agents
100 100 3 (2-7) Gradual escalation from 3 to 10 to 30 mg
Fludarabine Numru ta ’ Korsijiet ta ’ Qabel (firxa)
100 34 3 (1-10) Gradual escalation from 10 to 30 mg
10 sa 30 mg 10 sa 30 mg
92 100 3 (1-8) Gradual escalation from 10 to 30 mg
minn 10 sa 30 mg
Final Dosing Regimen
Kors ta ’ Dożagg Finali Rata ta ’ Rispons Globali
30 mg iv 3 x weekly
30 mg iv 3 x fil - 30 mg iv 3 x fil - ġimgħa ġimgħa 33 21
30 mg iv 3 x weekly
30
30 mg iv 3 x weekly
mg iv 3 x fil - ġimgħa 29
28
(%)
(95% Confidence Interval)
(95% Intervall ta ’
33 (23-43) 2 31 7 (5-8) 2 (1-2) 4 (3-5)
Perjodu Medju ta ’ Rispons
21 (8-33) 0 21 7 (5-23) 4 (1-5) 5 (3-7)
(xhur) (95% Intervall ta ’ kunfidenza)
29 (11-47) 0 29 11 (6-19) 4 (2-4) 7 (3-9)
(5- 8) (5- 23)
All patients Responders NR = not reached
Żmien Medju sa Rispons (xhur) (95% Intervall ta ’ kunfidenza)
16 (12-22) 33 (26-NR)
2 4 (1- 2) (1- 5)
26 (12-44) 44 (28-NR)
(95% Intervall ta '
28 (7-33) 36 (19-NR)
(3- 5) (3- 7)
5.2
(3- 9)
Pharmacokinetic properties
5. 2 Tagħrif Farmakokinetiku
MabCampath was administered as a 2 hour intravenous infusion, at the recommended dosing schedule, starting at 3 mg and increasing to 30 mg, 3 times weekly, for up to 12 weeks.
MabCampath kien mogħti bħala infużjoni fil- vini fuq perijodu ta ’ sagħtejn, fl- iskeda ta ’ doża rrakkomandata, li bdiet bi 3 mg u żdiedet sa 30 mg, 3 darbiet fil- ġimgħa, sa 12- il ġimgħa.
No short or long term animal studies have been conducted with MabCampath to assess carcinogenic and mutagenic potential.
Ma sarux studji ta ’ perijodu ta 'żmien qasir jew twil fuq l- annimali b' MabCampath sabiex jiġi stmat il - potenzjal karċinoġeniku u mutaġeniku.
6.3 Shelf life
33 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Solutions may be stored at 15°C-30°C or refrigerated.
Is- soluzzjonijiet jistgħu jinħażnu f’ temperatura ta ’ 15°C - 30°C jew jitqegħdu fil- friġġ.
2 ml vial (clear type I glass) containing 1 ml of concentrate.
Kunjett ta ’ 2ml (ħġieġ ċar ta 'tip I) li fih 1 ml ta ’ konċentrat.
Pack size: carton of 3 vials.
Daqs tal- pakkett: kartuna ta '3 kunjetti.
The vial contents should be inspected for particulate matter and discolouration prior to administration.
Il- kontenut tal- kunjett għandu jiġi spezzjonat għal frak żgħir u għal tibdil fil- kulur qabel ma jingħata.
If particulate matter is present or the concentrate is coloured, then the vial should not be used.
Jekk hemm xi frak jew il- konċentrat huwa kulurit, il- kunjett m' għandux jintuża.
The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
L- ammont meħtieġ tal- kontenut tal- kunjett għandu jiġi miżjud ma ’ 100 ml ta ’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew ta ’ glucose (5%).
The bag should be inverted gently to mix the solution.
Il- borża għandha tiġi maqluba bil- mod ta ’ taħt fuq sabiex titħallat is - soluzzjoni.
30 Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line.
Prodotti mediċinali oħra m' għandhomx jiġu miżjuda mas- soluzzjoni għall- infużjoni ta ’ MabCampath u m’ għandhomx jiġu infużi fl- istess waqt mill- istess pajp għal ġol- vina.
The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage.
Huwa rrakkomandat l- użu ta ’ ingwanti tal- latex u nuċċalijiet tas- sigurtà sabiex jiġi evitat esponiment f’ każ ta ’ ksur tal- kunjett jew tixrid aċċidentali ieħor.
31 ANNEX II
35 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANUFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U D- DETENTUR TA 'L- AWTORIZZAZZJONI RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANUFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U D- DETENTUR TA 'L - AWTORIZZAZZJONI RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
KG Birkendorfer Strasse 65 D-88397 Biberach an der Riss Deutschland
KG Birkendorfer Strasse 65 D- 88397 Biberach an der Riss Il- Ġermanja
Bayer Schering Pharma AG Müllerstrasse 178 D-13342 Berlin Deutschland
Bayer Schering Pharma AG Müllerstrasse 178 D- 13342 Berlin Il- Ġermanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to restricted medical prescription (See Annex 1:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
The MAH shall agree the details of an educational brochure with the National Competent Authorities.
Id- detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq għandu jiftiehem dwar id- dettalji ta ’ fuljett edukattiv ma ’ l- Awtoritajiet Kompetenti Nazzjonali.
The MAH shall ensure that all doctors who prescribe MabCampath are provided with a healthcare professional information pack containing the following: • Educational brochure • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Id- detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li t- tobba kollha li jippreskrivu MabCampath jingħataw pakkett ta ’ informazzjoni għal professjonisti fil- qasam tas- saħħa li jkun jikkonsisti minn: • Fuljett edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC), Fuljett ta ’ Tagħrif u Tikkettjar
Key elements to be included in the educational brochure
Punti essenzjali li għandhom jiġu inklużi fil- fuljett edukattiv
• The risk of opportunistic infections, in particular CMV viraemia • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
• Ir- riskju ta ’ infezzjonijiet opportunistiċi, b’ mod partikolari viremija CMV • Rakkomandazzjoni li jiġu evitati tilqim b’ vaċċini ħajjin għal ta ’ lanqas 12- il xahar wara t - tmiem ta ’ terapija b’ MabCampath • Ir- riskju ta ’ reazzjonijiet għall- infużjoni o Il- bżonn li tingħata mediċina minn qabel o Li kura għal reazzjonijiet ta ’ sensittività eċċessiva, li tinkludi miżuri għar - risuxxitazzjoni għandha tkun disponibbli waqt l- għoti o Li r- riskju ta ’ reazzjonijiet għall- infużjoni huwa l- ogħla fl- ewwel ġimgħa ta ’ terapija o Li jekk ir- reazzjoni hija moderata jew severa, id- doża għandha titkompla fl- istess livell (ie. id- doża m’ għandiex tiżdied) sakemm kull doża tkun ittollerata tajjeb o Li jekk ma tingħatax terapija għal aktar minn 7 ijiem, aMabCampath għandu jerġa ’ jinbeda mill- ġdid b’ doża li tiżdied b’ mod gradwali
• OTHER CONDITIONS
37 • KUNDIZZJONIJIET OĦRA
The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jkompli jissottometti PSURs kull sena jekk ma jiġix speċifikat mod ieħor mis- CHMP.
33 Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Mmaniġġjar ta ’ Riskji Id- Detentur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jwettaq l- istudji u l - attivitajiet ta ’ farmakoviġilanza oħra iddettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem f’ verżjoni 2. 0 tal- Pjan ta ’ Mmaniġġjar ta ’ Riskji (RMP) ippreżentata f’ Modolu 1. 8. 2 ta ’ l - Applikazzjoni tal- Awtorizzazzjoni għat- Tqehħid fis- Suq u kull aġġornament sussegwenti tal- RMP miftiehem mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji gwida tas- CHMP dwar Sistemi ta ’ Immaniġġjar ta ’ Riskji għall- prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi sottomess fl- istess waqt mar- Rapport Perjodiku Aġġornat tas- Sigurtà (PSUR) ta ’ wara.
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra dan, għandu jiġi sottomess RMP aġġornat: • Meta tinkiseb informazzjoni ġdida li jista ’ jkollha impatt fuq Speċifikazzjonijiet ta ’ Sigurtà Attwali, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskji. • Fi żmien 60 ġurnata minn meta tintlaħaq mira mportanti (farmakoviġilanza jew tnaqqis ta ’ riskji) • Mat- talba ta ’ l- EMEA
34 ANNEX III
38 ANNESS III
MabCampath 10 mg/ ml concentrate for solution for infusion Alemtuzumab
MabCampath 10 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Alemtuzumab
One ml contains 10 mg of alemtuzumab.
1ml fih 10 mg ta ’ alemtuzumab.
Each ampoule contains 30 mg of alemtuzumab.
Kull ampulla fiha 30mg ta ’ alemtuzumab.
Other ingredients:
Sustanzi oħra:
Disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate, water for injections.
Disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate, ilma għall- injezzjonijiet.
3 x 3 ml ampoules 30 mg/ 3 ml
3 ampulli x 3 ml 30 mg/ 3 ml
EXP Read the leaflet for the shelf life of the reconstituted product.
JIS Aqra l- fuljett għaż- żmien li jdum tajjeb il- prodott rikostitwit
Any spillage or waste material should be disposed of by incineration.
Kull tixrid jew materjal ta 'skart għandu jintrema permezz ta' inċinerazzjoni.
Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands
Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, l- Olanda
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
MabCampath 10 mg/ ml concentrate for solution for infusion Alemtuzumab Intravenous use
MabCampath 10 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Alemtuzumab Użu għal ġol- vini.
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
MabCampath 30 mg/ ml concentrate for solution for infusion Alemtuzumab
MabCampath 30 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Alemtuzumab
Each vial contains 30 mg of alemtuzumab.
1ml fih 30 mg ta ’ alemtuzumab. Kull kunjett fiha 30mg alemtuzumab.
3 x 1 ml vials 30 mg/ ml
3 kunjetti x 1 ml 30 mg/ 3 ml
Store in the original package in order to protect from light,.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mid- dawl.
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
MabCampath 30 mg/ ml concentrate for solution for infusion Alemtuzumab Intravenous use
MabCampath 30 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Alemtuzumab Użu għal ġol- vini.
43 PACKAGE LEAFLET:
47 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jista 'jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What MabCampath is and what it is used for 2.
X’ inhu MabCampath u għalxiex jintuża 2.
Before you are given MabCampath 3.
Qabel ma tingħata MabCampath 3.
How MabCampath is used 4.
Kif jintuża MabCampath 4.
How to store MabCampath 6.
Kif taħżen MabCampath 6.
WHAT MABCAMPATH IS AND WHAT IT IS USED FOR
X’ INHU MABCAMPATH U GĦALXIEX JINTUŻA
MabCampath is a monoclonal antibody.
MabCampath huwa antikorp monoklonali.
Monoclonal antibodies are proteins which specifically recognise and bind to a unique other protein called an antigen.
Antikorpi monoklonali huma proteini li jgħarfu u jintrabtu b' mod speċifiku ma 'proteina unika oħra li tissejjaħ antiġen.
MabCampath binds to an antigen on the surface of certain white blood cells, called lymphocytes.
MabCampath jintrabat ma 'antiġen fuq il - wiċċ ta' ċertu ċelluli bojod tad- demm, li jissejħu limfoċiti.
Patients with chronic lymphocytic leukaemia (CLL) have too many abnormal lymphocytes, which displace healthy cells in the bone marrow where most new blood cells are formed.
Pazjenti li għandhom lewkimja limfoċitika kronika (CLL) għandhom limfoċiti anormali iżżejjed, li jissostitwixxu ċelluli b' saħħithom fil- mudullun fejn il- biċċa l- kbira taċ- ċelluli l- ġodda tad- demm jiġu fformati.
This replacement of healthy cells also happens in the blood stream and other organs.
Din is- sostituzzjoni ta 'ċelluli b' saħħithom ssir ukoll fiċ- ċirkolazzjoni u f’ organi l- oħra.
After binding to the abnormal lymphocytes, MabCampath destroys them, and they are gradually removed from the body by normal biological processes.
Wara li jintrabat mal- limfoċiti anormali, MabCampath jiddistruġihom, u dawn jiġu eliminati minn ġol- ġisem b’ mod gradwali permess ta ’ proċessi bijoloġiċi normali.
MabCampath is used for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL) in cases where fludarabine combination chemotherapy is not appropriate for you.
MabCampath jintuża għall- kura ta ’ lewkimja limfoċitika kronika taċ- ċellula B (B- CLL) f’ każijiet fejn kimoterapija kombinata ta ’ fludarabine mhix xierqa għalik.
BEFORE YOU ARE GIVEN MABCAMPATH
QABEL MA TINGĦATA MABCAMPATH
Do not use MabCampath if you:
Tużax MabCampath jekk inti:
• are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath.
• allerġiku/ a (tbati minn sensittività eċċessiva) għal alemtużumab jew għal proteini ta 'oriġini simili jew għal sustanzi oħra ta ’ MabCampath.
Your doctor will inform you accordingly • have an infection • have HIV • have an active second malignancy • are pregnant (see also below).
It- tabib tiegħek se jinfurmak dwar dan. • għandek infezzjoni. • għandek HIV. • għandek tumur malinn attiv ieħor. • inti tqila (ara wkoll isfel).
Take special care with MabCampath:
Oqgħod attent ħafna b' Mabcampath:
When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “ Possible side effects”).
Meta tirċievi MabCampath l- ewwel darba, jista ’ jkollok xi effetti sekondarji wara l- ewwel infużjonijiet (ara Sezzjoni 4 “ Effetti sekondarji li jista 'jkollu ”).
These effects will gradually reduce as treatment is continued.
Dawn l- effetti jonqsu bil- mod hekk kif il- kura tissokta.
44 You may also be given
Inti tista ’ tingħata wkoll
• steroids, antihistamines or analgesics (treatment for fever) to help to reduce some of the side effects.
48 • sterojdi, antistamini jew analġeżiċi (kura għad- deni) biex jgħinu jtaffu xi ftit mill- effetti sekondarji.
The dosage of MabCampath will not be increased until the effects are reduced.
Id- dożaġġ ta ’ MabCampath mhux ser titqawwa qabel l- effetti jonqsu.
MabCampath treatment may reduce your natural resistance to infections
Kura b’ MabCampath tista ’ tnaqqas ir- reżistenza naturali tiegħek għall- infezzjonijiet
• antibiotics and antivirals may be given to provide you with extra protection.
• jistgħu jingħatawlek anti- bijotiċi u antivirali sabiex jipprovdulek aktar protezzjoni.
You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus) during your MabCampath therapy and for at least 2 months afterwards.
Waqt it- terapija tiegħek b’ MabCampath u għal ta ’ lanqas xahrejn wara inti se tiġi eżaminat għal sintomi ta ’ ċertu tip ta ’ infezzjoni virali li tissejjaħ cytomegalovirus (CMV).
Your doctor will monitor you carefully if you
It- tabib tiegħek ser jissorveljak b’ attenzjoni, jekk inti
• have heart disease or chest pains and/ or you are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse.
• għandek mard tal- qalb jew uġigħ fis- sider u/ jew qed tirċievi kura biex tnaqqas il- pressjoni tad- demm, peress li MabCampath jista ’ jaggrava dawn il- kundizzjonijiet.
Patients with these conditions may be at higher risk of a heart attack.
Pazjenti b' dawn il- kundizzjonijiet jistgħu jkunu f' riskju ogħla ta 'attakk tal- qalb.
• have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart rate, body weight) while receiving MabCampath.
• fil- passat inti ġejt ikkurat b' kimoterapiji jew mediċini ġenerali li għandhom riskju għoli li jikkaġunaw ħsara lill- qalb, it- tabib tiegħek għandu mnejn ikun jixtieq jimmonitorja l- funzjoni kardijaka tiegħek (ECG, rata tal- qalb, piż tal- ġisem) waqt li tkun qed tirċievi MabCampath.
• have other side effects, most often blood disorders from taking MabCampath.
It- tabib tiegħek se jkun jissorvelja l- effetti tal- kura u l- progress tiegħek
Your doctor will be monitoring the effects of treatment and your progress carefully by examining you and by taking blood samples for analysis on a regular basis.
b’ attenzjoni billi jeżaminak u billi jieħu kampjuni tad- demm għall- analiżi fuq bażi regolari.
• are over 65 years of age as you may be more intolerant to the medicine than other patients.
• għandek aktar minn 65 sena, peress li tista ’ tkun aktar intolleranti għal mediċina minn pazjenti oħra.
You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you.
Jista ’ jkollok esperjenza ta ’ reazzjoni allerġika jew ta ’ sensittività eċċessiva għas- soluzzjoni ta ’ MabCampath, speċjalment kontra l- proteina li tinsab fiha, waqt li tkun qed tingħata l- infużjoni.
Your doctor will treat you for this, if this happens.
It - tabib tiegħek jikkurak għal dan, jekk dan iseħħ.
If you are a male or female of childbearing potential, then you should ensure that you use a reliable form of birth control during and for at least 6 months after treatment.
Jekk inti raġel jew mara li jista ’ jkollok it- tfal, għandek tiżgura li tuża mezz affidabli ta ’ kontraċezzjoni waqt u għal ta ’ l- anqas 6 xhur wara l- kura.
This is because the effects of MabCampath on reproduction are unknown.
Dan għaliex l- effetti ta ’ MabCampath fuq ir- riproduzzjoni mhumiex magħrufa.
The safety and efficacy of MabCampath has not been established in children (below 17 years of age) or in patients who have kidney or liver disorders.
Is- sigurtà u l- effikacja ta ’ MabCampath għadhom mhumiex magħrufa fit- tfal (b’ età taħt 17- il sena) jew f’ pazjenti li għandhom disturbi tal- kliewi u tal- fwied.
Thus, MabCampath is not recommended in children below 17 years of age.
Għalhekk, MabCampath mhux irrakkomandat fit- tfal li għandhom inqas minn 17- il sena.
You should inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer agents.
B’ mod partikolari, m’ għandekx tingħata MabCampath fi żmien 3 ġimgħat mit- teħid ta ’ mediċini oħra kontra l- kanċer.
Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment.
Barra dan, m’ għandekx tkun vaċċinat b’ vaċċini b’ virus ħaj waqt il- kura u għal ta ’ l- anqas 12- il xahar wara li tkun temmejt il- kura tiegħek.
Speak to your doctor before receiving any vaccinations.
Kellem lit- tabib tiegħek qabel ma tirċievi xi vaċċini.
Pregnancy
49 Tqala
MabCampath must not be administered to patients who are pregnant, therefore if you:
MabCampath m’ għandux jingħata lil pazjenti li huma tqal, għalhekk jekk inti:
45 • are pregnant or you think you may be pregnant, you should tell your doctor immediately. • are of childbearing potential, then you should avoid becoming pregnant by using effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.
• tqila, jew taħseb li tista ’ tkun tqila, għandek tgħarraf lit- tabib tiegħek minnufih. • jista ’ jkollok it- tfal, għandek tevita li toħroġ tqila billi tuża mezzi effettivi ta ’ kontraċezzjoni qabel ma ’ tibda l- kura, waqt il- kura u għal 6 xhur wara li tintemm il- kura.
You should stop breast-feeding when you start your treatment and you should not begin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor on the matter.
Għandek tieqaf tredda ’ meta tibda l- kura tiegħek u m’ għandekx tibda tredda ’ mill- ġdid qabel ta 'l - anqas 4 ġimgħat wara li tkun spiċċajt il- kura u tkun tkellimt mat- tabib tiegħek dwar dan.
Driving or using machines
Sewqan u tħaddim ta 'magni
No studies of the effects of MabCampath have been performed.
Ma saru l- ebda studji dwar l- effetti ta 'MabCampath.
However, caution should be exercised as confusion and sleepiness have been reported.
Madankollu, għandu jkun hemm kawtela peress li ġew irrapportati każijiet ta 'konfużjoni u ngħas.
You should ask your doctor for advice.
Għandek issaqsi lit- tabib tiegħek għal parir.
HOW MABCAMPATH IS USED
KIF JINTUŻA MABCAMPATH
MabCampath is contained in solution in a glass ampoule.
MabCampath jinsab f’ soluzzjoni f' ampulla tal- ħġieġ.
The ampoule contents are added to a sodium chloride or glucose solution contained in a drip bag.
Il- kontenut ta ’ l- ampulla huwa miżjud ma ’ soluzzjoni ta ’ sodium chloride jew glucose li tinsab f’ borża tad- dripp.
The lines from the drip bag are then connected directly into one of your veins (see also ‘ information intended for medical or healthcare professionals’).
Il- pajpijiet mill- borża tad- dripp imbagħad huma konnessi direttament ma ’ waħda mill- vini tiegħek (ara wkoll ‘ Tagħrif maħsub għall - professjonisti fil- qasam mediku ’).
MabCampath solution goes directly into your bloodstream through a vein.
Is- soluzzjoni MabCampath tmur direttament fiċ- ċirkolazzjoni tiegħek permezz ta ’ vina.
This is known as intravenous infusion.
Din hija magħrufa bħala infużjoni fil- vini.
Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.
Kull darba li tingħata MabCampath, dan jieħu madwar sagħtejn biex is- soluzzjoni kollha tidħol fid- demm.