qanastek/EMEA-V3 huggingface dataset:
congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiency severe combined immunodeficiency Wiskott Aldrich syndrome
agammaglobulinemija u ipogammaglobulinemija konġenitali immunodefiċjenza varjabbli komuni immunodefiċjenza kkombinata severa is- sindrome ta ’ Wiskott Aldrich
• Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. • Children with congenital AIDS and recurrent infections.
• Majeloma jew lewkimja limfoċitika kronika b’ ipogammaglobulinemija severa sekondarja u infezzjonijiet rikorrenti. • Tfal b’ AIDS konġenitali u infezzjonijiet rikorrenti.
Immunomodulation • Immune thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. • Guillain-Barré syndrome. • Kawasaki disease.
Immunomodulazzjoni • Purpura tromboċitopenika immuni (ITP), fit- tfal jew fl- adulti li qegħdin f’ riskju għoli ta ’ ħruġ ta ’ demm, jew qabel operazzjoni biex l- għadd tal- plejtlits jiġi kkoreġut. • Sindrome ta ’ Guillain Barré. • Il- marda ta ’ Kawasaki.
2 Allogeneic bone marrow transplantation
2 Trapjant alloġeneiku tal- mudullun
Posology The dose and dosage regimen is dependent on the indication.
Pożoloġija Id- doża u l- kors tad- dożaġġ jiddependu fuq l- indikazzjoni.
In replacement therapy the dosage may need to be individualised for each patient depending on the pharmacokinetic and clinical response.
Fit- terapija tas- sostituzzjoni, jista ’ jkun hemm bżonn li d- dożaġġ ikun individwalizzat għal kull pazjent skond ir- rispons farmakokinetiku u kliniku.
Replacement therapy in primary immunodeficiency syndromes The dosage regimen should achieve a trough IgG level (measured before the next infusion) of at least 4 to 6 g/l.
Terapija tas- sostituzzjoni f’ sindromi ta ’ l- immunodefiċjenza primarja Il- kors tad- dożaġġ għandu jilħaq livell minimu ta ’ IgG (imkejjel qabel l- infużjoni li jmiss) ta ’ mill - inqas 4 sa 6 g/ l.
Three to six months are required after the initiation of therapy for equilibration to occur.
Hemm bżonn ta ’ minn tlieta sa sitt xhur wara l- bidu tat- terapija biex isseħħ l- biex jintlaħaq livell stabbli.
The recommended starting dose is 0.4 to 0.8 g/kg body weight (bw) followed by at least 0.2 g/kg bw every three weeks.
Id- doża inizjali rrakkomandata hi ta ’ 0. 4 sa 0. 8 g/ kg piż tal- ġisem, segwita minn mill- inqas 0. 2 g/ kg piż tal- ġisem kull tliet ġimgħat.
The dose required to achieve a trough level of 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month.
Id- doża meħtieġa biex jintlaħaq livell minimu ta ’ 6 g/ l hu ta ’ 0. 2 - 0. 8 g/ kg piż tal- ġisem/ xahar.
The dosage interval when steady state has been reached varies from two to four weeks.
L - intervall tad- dożaġġ meta l- istat stabbli jkun intlaħaq, ivarja minn ġimagħtejn sa erba ’ ġimgħat.
Trough levels should be measured in order to adjust the dose and dosage interval.
L- inqas livelli għandhom jitkejlu sabiex id- doża u l- intervall tad- dożaġġ ikunu aġġustati.
Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections The recommended dose is 0.2 to 0.4 g/kg bw every three to four weeks.
Id- doża rrakkomandata hi ta ’ 0. 2 sa 0. 4 g/ kg piż tal- ġisem kull tlieta jew erba ’ ġimgħat.
Immune thrombocytopenic purpura For the treatment of an acute episode, 0.8 to 1 g/kg bw on day one, which may be repeated once within three days, or 0.4 g/kg bw daily for two to five days.
Purpura tromboċitopenika immuni Għall- kura ta ’ episodju akut, 0. 8 sa 1. 0 g/ kg piż tal- ġisem fl- ewwel jum, li tista ’ tkun ripetuta darba fi żmien tlett ijiem, jew 0. 4 g/ kg piż tal- ġisem kuljum għal minn jumejn sa ħamest ijiem.
Guillain-Barré syndrome 0.4 g/kg bw/day for three to seven days.
Sindrome ta ’ Guillain- Barré 0. 4 g/ kg piż tal- ġisem/ kuljum għal minn tlieta sa sebat ijiem.
Experience in children is limited.
L- esperjenza fit- tfal hi limitata.
Kawasaki disease 1.6 to 2.0 g/kg bw should be administered in divided doses over two to five days or 2.0 g/kg bw as a single dose.
1. 6 sa 2. 0 g/ kg piż tal- ġisem għandha tingħata f’ dożi maqsuma fuq perijodu ta ’ minn jumejn sa ħamest ijiem jew 2. 0 g/ kg piż tal- ġisem bħala doża waħda.
Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplantation.
Il- kura bl- immunoglobulina normali umana tista ’ tintuża bħala parti mill- kors ta ’ ta ’ tħejjija u wara t - trapjant.
For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored.
Għall- kura ta ’ infezzjonijiet u l- profilassi biex it- trapjant ma jkunx irruftat, id- dożaġġ għandu jingħata fuq bażi individwali.
The starting dose is normally 0.5 g/kg bw/week, starting seven days before transplantation and continued for up to three months after the transplantation.
Id- doża tal- bidu hi normalment ta ’ 0. 5 g/ kg piż tal- ġisem/ ġimgħa, li tibda sebat ijiem qabel it- trapjant u tkompli sa tliet xhur wara t- trapjant.
In case of persistent lack of antibody production, a dose of 0.5 g/kg bw/month is recommended until antibody levels return to normal.
F’ każ ta ’ nuqqas persistenti ta ’ produzzjoni ta ’ antikorpi, dożaġġ ta ’ 0. 5 g/ kg piż tal- ġisem/ xahar hu rrakkomandat sakemm il- livelli ta ’ l- antikorpi jerġgħu lura għan- normal.
3 Indication Replacement therapy
3 Indikazzjoni Terapija tas- sostituzzjoni
Frequency of injections
Frekwenza ta ’ l- injezzjonijiet
– in primary immunodeficiency
– pazjenti b’ immunodefiċjenza primarja
starting dose:
doża tal- bidu:
0.4–0.8 g/kg bw
0. 4– 0. 8 g/ kg piż tal- ġisem
thereafter:
wara dak il - perijodu:
every two to four weeks to obtain
kull ġimagħtejn sa erba ’ ġimgħat biex tikseb livell minimu ta ’ IgG
0.2–0.8 g/kg bw
0. 2– 0. 8 g/ kg piż tal- ġisem
IgG trough levels of at least 4–6 g/l
ta ’ mill- inqas 4– 6 g/ l
– in secondary immunodeficiency
pazjenti b’ immunodefiċjenza sekondarja
0.2–0.4 g/kg bw
0. 2– 0. 4 g/ kg piż tal- ġisem
every three to four weeks to obtain IgG trough levels of at least 4–6 g/l
kull tlieta sa erba ’ ġimgħat biex tikseb livell minimu ta ’ IgG ta ’ mill- inqas 4– 6 g/ l
– Children with AIDS
– Tfal bl- AIDS
every three to four weeks
kull tlieta sa erba ’ ġimgħat
– Immune thrombocytopenic purpura
– Purpura tromboċitopenika immuni
g/kg bw or
0. 8– 1. 0 g/ kg piż tal- ġisem
on day one, possibly repeated once within three days
fl- ewwel jum, possibbilment ripetuta fi żmien tlitt ijiem
0.4 g/kg bw/d
0. 4 g/ kg piż tal - ġisem/ kuljum
for two to five days
għal minn jumejn sa ħamest ijiem
– Guillain-Barré syndrome
– Sindrome ta ’ Guillain- Barré
for three to seven days
għal minn tlieta sa sebat ijiem
– Kawasaki disease
– Il- marda ta ’ Kawasaki.
g/kg bw
1. 6– 2. 0 g/ kg piż tal- ġisem
in divided doses over two to five days in association with acetylsalicylic acid
f’ dożi li jinqasmu fuq perijodu ta ’ minn jumejn sa ħamest ijiem flimkien ma ’ acetylsalicylic acid
2 g/kg bw
2 g/ kg piż tal - ġisem
acetylsalicylic acid
f’ doża waħda flimkien ma ’ acetylsalicylic acid
treatment of infections and prophylaxis of graft versus host disease
kura ta ’ infezzjonijiet u profilassi ta ’ trapjanti kontra l- marda ospitu
0.5 g/kg bw
0. 5 g/ kg piż tal - ġisem
every week from seven days before up to three months after transplantation
kull ġimgħa minn sebat ijiem qabel, sa tliet xhur wara t- trapjant
every month until antibody levels return to normal
kull xahar sakemm il- livelli ta ’ l - antikorpi jerġgħu ’ lura għan - normal
Method of administration Human normal immunoglobulin should be infused intravenously.
Metodu ta ’ kif għandu jingħata L- immunoglobulina normali umana għandha tingħata bħala infużjoni minn ġol- vina.
The initial infusion rate is 0.3 ml/kg bw/hr.
Ir- rata inizjali ta ’ l- infużjoni hi ta ’ 0. 3 ml/ kg piż tal- ġisem/ siegħa.
If well tolerated, the rate of administration may gradually be increased to 4.8 ml/kg bw/hr.
Jekk tkun ittollerata tajjeb, ir- rata tista ’ tiżdied gradwalment sa massimu ta ’ 4. 8 ml/ kg piż tal- ġisem/ siegħa.
In a clinical study in PID patients, the maximum infusion rate was 7.2 ml/kg bw/hr.
Fi studju kliniku f’ pazjenti bil- PID, ir- rata massima ta ’ l- infużjoni kienet ta ’ 7. 2 ml/ kg piż tal- ġisem/ siegħa.
Hypersensitivity to the active substance or to any of the excipients.
4 Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Hypersensitivity to homologous immunoglobulins, especially in the very rare cases of IgA deficiency when the patient has antibodies against IgA.
Sensittività eċċessiva għal immunoglobulini omologi, speċjalment f’ każijiet rari ħafna ta ’ defiċjenza ta ’ IgA, meta l- pazjent ikollu antikorpi kontra IgA.
Patients with hyperprolinaemia.
Pazjenti b’ iperprolinemija.
The recommended infusion rate given under section 4.2 "Method of administration" must be followed closely.
Pożoloġija u metodu ta ’ kif għandu jingħata ” għandha tkun segwita mill- qrib.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Il- pazjenti jridu jkunu mmonitorjati mill- qrib u jkunu osservati bl- attenzjoni għal kwalunkwe sintomi matul il- perijodu ta ’ l- infużjoni.
4 Certain adverse reactions may occur more frequently: – in case of high rate of infusion, – in patients with hypo- or agammaglobulinaemia with or without IgA deficiency, – in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.
Ċerti reazzjonijiet avversi jistgħu jseħħu aktar b’ mod frekwenti: – f’ każ ta ’ rata għolja ta ’ infużjoni, – f’ pazjenti b’ ipo - jew agammaglobulinemija bi jew mingħajr defiċjenza ta ’ IgA, – f’ pazjenti li jirċievu immunoglobulina normali umana għall- ewwel darba, jew f’ każijiet rari, meta l- prodott ta ’ l- immunoglobulina normali umana jinbidel ma ’ ieħor, jew meta kien hemm intervall twil mill- aħħar infużjoni.
They can occur in the very rare cases of IgA deficiency with anti-IgA antibodies.
Dawn jistgħu jseħħu f’ każijiet rari ħafna ta ’ defiċjenza ta ’ IgA b’ antikorpi anti- IgA.
Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.
B’ mod rari, l- immunoglobulina normali umana tista ’ tikkaġuna tnaqqis fil- pressjoni tad- demm b’ reazzjoni anafilattika, anki f’ pazjenti li qabel ittolleraw kura b’ immunoglobulina normali umana.
Potential complications can often be avoided by ensuring that patients: – are not sensitive to human normal immunoglobulin by initially infusing the product slowly (0.3 ml/kg bw/hr); – are carefully monitored for any symptoms throughout the infusion period.
Kumplikazzjonijiet potenzjali jistgħu ta ’ spiss jiġu evitati billi tiżgura li l- pazjenti: – ma jkunux sensittivi għal immunoglobulina normali umana billi inizjalment tagħti infużjoni bil - mod tal- prodott (0. 3 ml/ kg piż tal- ġisem/ siegħa); – ikunu mmonitorjati bl- attenzjoni għal kwalunkwe sintomi matul il- perijodu ta ’ l- infużjoni.
In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for one hour after, in order to detect potential adverse signs.
B’ mod partikulari, pazjenti li huma naive għal immunoglobulina normali umana, pazjenti li qalbu minn prodott alternattiv IVIg jew fejn kien hemm intervall twil mill- aħħar infużjoni, għandhom ikunu mmonitorjati matul l- ewwel infużjoni u għal siegħa wara, sabiex ikunu osservati għal xi sinjali avversi potenzjali.
All other patients should be observed for at least twenty minutes after administration.
Il- pazjenti l- oħrajn kollha għandhom ikunu osservati għal mill- inqas 20 minuta wara l- għoti.
There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients.
Hemm evidenza klinika ta ’ rabta bejn l- għoti ta ’ IVIg u avvenimenti tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari u trombożi profonda tal- vini li hu maħsub li huma relatati ma ’ żieda relattiva fil- viskosità tad- demm minħabba l- influss qawwi ta ’ immunoglobulina f’ pazjenti li qegħdin f’ riskju.
Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients and patients with diseases which increase blood viscosity).
Wieħed għandu joqgħod attent meta jikteb riċetta biex tingħata l - infużjoni ta ’ IVIg lil pazjenti ħoxnin, u f’ pazjenti b’ fatturi ta ’ riskju li kienu jeżistu minn qabel għal avvenimenti trombotiċi (bħal età avvanzata, pressjoni tad- demm għolja, dijabete mellitus, u b’ mard vaskulari jew episodji trombotiċi fil- passat, pazjenti li wirtu jew żviluppaw disturbi trombofiliċi, pazjenti li jqattgħu perijodi twal fl- istess pożizzjoni, pazjenti li huma ipovolemiċi b’ mod sever, u pazjenti b’ mard li jżid il- viskosità tad- demm).
Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Każijiet ta ’ insuffiċjenza akuta renali kienu rrappurtati f’ pazjenti li kienu qed jingħataw terapija b’ IVIg.
In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, being overweight, concomitant nephrotoxic medicinal products or age over 65.
Fil- biċċa l- kbira tal- każijiet, kienu identifikati fatturi ta ’ riskju, bħal insuffiċjenza renali li kienet teżisti minn qabel, dijabete mellitus, ipovolemija, piż żejjed, użu fl- istess ħin ta ’ prodotti mediċinali nefrotossiċi jew età ta ’ aktar minn 65 sena.
In case of renal impairment, IVIg discontinuation should be considered.
F’ każ ta ’ indeboliment renali, wieħed għandu jikkunsidra li jwaqqaf l- IVIg.
While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Filwaqt li dawn ir- rapporti ta ’ disfunzjoni renali u insuffiċjenza akuta renali kienu assoċjati ma ’ l- użu ta ’ ħafna mill- prodotti IVIg lliċenzjati, kien hemm aktar prodotti li fihom is- sucrose bħala stabbilizzatur milli wieħed jistenna.
In patients at risk, the use of IVIg products that do not contain sucrose may be considered.
F’ pazjenti li għandhom fatturi ta’ riskju, l- użu ta ’ prodotti IVIg li ma fihomx sucrose, jista ’ jkun ikkunsidrat.
Privigen does not contain sucrose or other sugars.
Privigen ma fihx sucrose jew xi zokkor ieħor.
In patients at risk of acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
5 F’ pazjenti li qegħdin f’ riskju għal insuffiċjenza akuta renali jew għal reazzjonijiet avversi tromboemboliċi, il- prodotti IVIg għandhom jingħataw bir- rata minima ta ’ l- infużjoni biex tingħata d - doża.
In all patients, IVIg administration requires: – adequate hydration prior to the initiation of the infusion of IVIg – monitoring of urine output – monitoring of serum creatinine levels – avoidance of concomitant use of loop diuretics.
Fil- pazjenti kollha, l- għoti ta ’ IVIg jeħtieġ: – idratazzjoni adegwata qabel il- bidu ta ’ l- infużjoni ta ’ IVIg – monitoraġġ ta ’ l- ammont ta ’ awrina – monitoraġġ tal- livelli tal- krejatinina fis- serum – li wieħed jevita l- użu fl- istess ħin ta ’ dijuretiċi tat- tip loop.
The treatment required depends on the nature and severity of the side effect.
Il- kura meħtieġa tiddependi fuq in- natura u s- severità ta ’ l- effett sekondarju.
In case of shock, standard medical treatment for shock should be implemented.
F’ każ ta ’ xokk, il- kura medika standard għal xokk għandha tkun implimentata.
Information on safety with respect to transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the 5 inactivation/removal of viruses.
Informazzjoni dwar is- sigurtà fir- rigward ta ’ mediċini li jistgħu jkunu trasmessi Miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill- użu ta ’ prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l- għażla tad- donaturi, screening ta ’ donazzjonijiet individwali u ta ’ pools tal- plażma għal markaturi speċifiċi ta ’ infezzjoni u l- inklużjoni ta ’ miżuri effettivi fil - proċess tal- manifattura għall- inattivazzjoni/ tneħħija ta ’ viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jingħataw prodotti mediċinali ppreparati minn demm jew plażma umana, il- possibbiltà li orġaniżmi infettivi jiġu trasmessi ma tistax tiġi eskluża għal kollox.
The measures taken are considered effective for enveloped viruses such as HIV, HBV, and HCV, and for the non-enveloped viruses HAV and B19V.
Il- miżuri meħuda huma kkunsidrati li huma effettivi għal viruses enveloped bħal HIV, HBV u HCV, u għall- viruses non- enveloped HAV u B19V.
There is reassuring clinical experience regarding the lack of hepatitis A or B19V transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Hemm esperjenza klinika inkoraġġanti dwar in- nuqqas ta ’ trasmissjoni ta ’ epatite A jew ta ’ B19V permezz ta ’ l- immunoglobulini, u hu maħsub ukoll li l- kontenut ta ’ l- antikorpi għandu sehem importanti fis- sigurtà virali.
It is strongly recommended that every time Privigen is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Hu rrakkomandat bil- qawwa li kull darba li jingħata Privigen lil pazjent, l- isem u n- numru tal- lott tal - prodott għandhom ikunu rreġistrati sabiex tinżamm ħolq bejn il- pazjent u l- lott tal- prodott.
4.5 Interaction with o ther medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Live attenuated virus vaccines Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella and varicella for a period of at least six weeks and up to three months.
Tilqim b’ virus ħaj attenwat L- għoti ta ’ l- immunoglobulina jista ’ jnaqqas l- effikaċja ta ’ tilqim b’ virus ħaj attenwat, bħal dawk kontra l- ħosba, il- gattone, il- ħosba Ġermaniża u l- ġidri r- riħ, għal perijodu ta ’ mill- inqas sitt ġimgħat, u sa tliet xhur.
After administration of this product, an interval of three months should elapse before vaccination with live attenuated virus vaccines.
Wara l- għoti ta ’ dan il- prodott, għandu jitħalla jgħaddi intervall ta ’ tliet xhur qabel it - tilqima b’ vaċċini b’ viruses ħajjin attenwati.
In the case of measles, this impairment may persist for up to one year.
Fil- każ tal- ħosba, dan l- indeboliment fl- effett jista ’ jippersisti sa sena.
Therefore patients receiving measles vaccine should have their antibody status checked.
Għalhekk, il- pazjenti li jkunu se jieħdu tilqima kontra l- ħosba, għandu jkollhom l - istat ta ’ l- antikorpi tagħhom iċċekkjat qabel jieħdu t- tilqima.
Interference with serological testing After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Interferenza ma ’ l- ittestjar seroloġiku Wara l- injezzjoni ta ’ l- immunoglobulina, iż- żieda temporanja tad- diversi antikorpi li jkunu ttrasferiti b’ mod passiv fid- demm tal- pazjent, tista ’ tirriżulta f’ riżultati pożittivi fl- ittestjar seroloġiku, li jqarrqu b’ dak li jkun.
Passive transmission of antibodies to erythrocyte antigens, e.g.
It- trasmissjoni passiva ta ’ antikorpi lil antiġeni eritroċiti, eż.
Coombs test).
A, B, D, tista ’ tfixkel xi testijiet seroloġiċi għal allo- antikorpi taċ- ċelluli ħomor (eż. it- test ta ’ Coombs).
4.6 Pregnancy and lactation
6 4. 6 Tqala u treddigħ
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Is- sigurtà ta ’ dan il- prodott mediċinali għall- użu fit- tqala umana ma kinitx stabbilita fi provi kliniċi kkontrollati, u għalhekk għandu jingħata biss bl- attenzjoni lil nisa tqal u lil ommijiet li qed ireddgħu.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Mill- esperjenza klinika bl- immunoglobulini wieħed ma jistenna l- ebda effetti ħżiena jekk jingħataw matul kors it- tqala, kemm fuq il- fetu u kemm fuq it- tarbija tat- twelid.
Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
L- immunoglobulini jitneħħew fil- ħalib u jistgħu jikkontribwixxu għal trasferiment ta ’ antikorpi protettivi lit- tarbija tat- twelid.
No effects on ability to drive and use machines have been observed.
L- ebda effetti fuq il- ħila biex issuq u tuża l- magni ma kienu osservati.
With human normal immunoglobulin for intravenous administration, adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Bl- immunoglobulina normali umana għall- għoti intravaskulari, reazzjonijiet avversi bħal tertir ta ’ bard, uġigħ ta ’ ras, deni, rimettar, reazzjonijiet allerġiċi, dardir, artralġja, pressjoni tad- demm baxxa u uġigħ moderat fin- naħa t’ isfel tad- dahar, jistgħu jseħħu kultant.
Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
B’ mod rari, l- immunoglobulini normali umani jistgħu jikkawżaw tnaqqis għal għarrieda fil- pressjoni tad- demm u, f’ każijiet iżolati, xokk anafilattiku, anki meta l- pazjent ma jkun wera l- ebda sensittività eċċessiva meta jkun ingħata l- mediċina fil- passat.
Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.
Il- każijiet ta ’ meninġite asettika riversibbli, każijiet iżolati ta ’ anemija/ emolisi emolitika riversibbli u każijiet rari ta ’ reazzjonijiet temporanji tal- ġilda, kienu osservati bl- immunoglobulina normali umana.
6 Increase in serum creatinine level and/or acute renal failure have been observed.
Żieda fil- livell tal- krejatinina fis- serum u/ jew insuffiċjenza akuta renali kienu wkoll osservati.
Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
Reazzjonijiet tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari u trombożi profonda tal- vini.
Two clinical studies with Privigen were performed, one in patients with primary immunodeficiency (PID) and one in patients with immune thrombocytopenic purpura (ITP).
Saru żewġ studji kliniċi bi Privigen, wieħed f’ pazjenti b’ immunodefiċjenza primarja (PID) u ieħor f’ pazjenti b’ purpura tromboċitopenika immuni (ITP).
In the PID study 80 subjects were enrolled and treated with Privigen.
Fl- istudju dwar il- PID, 80 pazjent kienu rreġistrati u kkurati bi Privigen.
Of these, 72 completed the twelve months of treatment.
Minn dawn, 72 temmew it- tnax- il xahar tal- kura.
The ITP study was performed in 57 patients.
L- istudju dwar il - ITP sar fuq 57 pazjent.
Most adverse drug reactions (ADRs) observed in the two clinical studies were mild to moderate in nature.
Il- biċċa l- kbira tar- reazzjonijiet avversi tal- mediċina (ADRs) osservati fiż- żewġ studji kliniċi kienu minn ħfief sa moderati fin- natura tagħhom.
The ADRs reported in the two studies are summarised and categorised according to the MedDRA System organ class and frequency below.
L- ADRs irrappurtati fiż- żewġ studji jidhru fil- qosor hawn taħt u kkategorizzati skond is- Sistema tal - Klassi ta ’ l- Organi MedDRA u skond frekwenza.
Frequency per infusion has been evaluated using the following criteria: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1 000 to < 1/100).
Il- frekwenza għal kull infużjoni kienet evalwata billi ntużaw il- kriterji li ġejjin: komuni ħafna (≥1/ 10), komuni (≥1/ 100 sa < 1/ 10), mhux komuni (≥1/ 1 000 sa < 1/ 100).
Within each frequency grouping, undesirable effects are presented in order of decreasing severity.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa l- aktar serji huma mniżżla l- ewwel, segwiti minn dawk anqas serji.
Frequency of Adverse Drug Reactions (ADRs) in clinical studies with Privigen
Frekwenza ta ’ Reazzjonijiet Avversi tal- Mediċina (ADRs) fi studji kliniċi bi Privigen
MedDRA System Organ Class
Sistema tal- Klassi ta ’ l - Organi tal- MedDRA
MedDRA preferred term
Terminu ppreferut tal- MedDRA
ADR frequency category
Kategorija ta ’ frekwenza ta ’ l- ADR
Bilirubin conjugated increased, blood bilirubin unconjugated increased, Coombs direct test positive, Coombs test positive, blood lactate dehydrogenase increased, haematocrit decreased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, blood pressure decreased, blood pressure increased, body temperature increased, haemoglobin decreased
żieda fil- bilirubina konjugata, żieda fil- bilirubina mhux konjugata fid- demm, test dirett ta ’ Coombs b’ riżultat pożittiv, test ta ’ Coombs b’ riżultat
Anaemia, anisocytosis
Anemija, anisoċitosi
Headache Dizziness, head discomfort, somnolence, tremor
Disturbi fis- sistema nervuża Disturbi respiratorji, toraċiċi u medjastinali
Respiratory, thoracic and mediastinal disorders
Uġigħ ta ’ ras Sturdament, skonfort fir- ras, ngħas, rogħda Dispnea
Uncommon
Komuni ħafna Mhux komuni Mhux komuni
Vomiting, nausea Diarrhoea
Rimettar, dardir Dijarea
Pruritus, skin disorder
Ħakk, disturb fil- ġilda
Back pain, neck pain, pain in extremity, musculoskeletal stiffness
Uġigħ fid- dahar, uġigħ fl- għonq, uġigħ fl - estremitajiet, ebusija muskolu- skeletrali
Chills, fatigue, pyrexia Chest pain, general symptom, asthenia, influenza like illness, hyperthermia, pain
Tertir ta ’ bard, għeja kbira, deni Uġigħ fis- sider, sintomi ġenerali, astenja, mard qisu influwenza, ipertermija, uġigħ
Hyperbilirubinaemia
Iperbilirubinemja
For safety with respect to transmissible agents, see section 4.4.
Għas- sigurtà fir- rigward ta ’ mediċini trasmissibbli, ara sezzjoni 4. 4.
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.
Doża eċċessiva tista ’ twassal għal ammont eċċessiv ta ’ fluwidu u iperviskosità, partikularment f’ pazjenti li qegħdin f’ riskju, li jinkludi pazjenti anzjani jew pazjenti b’ indeboliment renali.
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
5. 1 Tagħrif farmakodinamiku
Human normal immunoglobulin contains the IgG antibodies present in the normal population.
L- immunoglobulina normali umana fiha l- antikorpi IgG li ssibhom fil- popolazzjoni normali.
It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Tkun normalment ippreparata minn plażma miġbura minn mhux inqas minn 1, 000 donatur.
It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Għandha distribuzzjoni ta ’ sottoklassijiet ta ’ immunoglobulina G li tixbah proporzjonalment mill- qrib lil dik li tinsab normalment fil- plażma umana.
Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Dożi adegwati ta ’ dan il- prodott mediċinali jistgħu iżidu għan - normal livelli baxxi ta ’ immunoglobulina G.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Il- mekkaniżmu kif taħdem l- immunoglobulina f’ indikazzjonijiet oħrajn minbarra t- terapija tas - sostituzzjoni, ma jistax ikun spjegat b’ mod sħiħ, iżda jinkludi effetti immunomodulatorji.
The safety and efficacy of Privigen was evaluated in two prospective, open-label, single-arm, multicenter studies performed in Europe (ITP study) and Europe and USA (PID study).
Is- sigurtà u l- effikaċja ta ’ Privigen kienu evalwati f’ żewġ studji prospettivi, open- label, single- arm, multiċentriċi, li saru fl- Ewropa (studju ITP), u fl- Ewropa u fl- Istati Uniti ta ’ l- Amerika (studju PID).
Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
L- immunoglobulina normali umana hi immedjatament u kompletament bijodisponibbli fiċ - ċirkolazzjoni tal- pazjent meta tingħata fil- vina.
It is distributed relatively rapidly between plasma and extravascular fluid, equilibrium between the intra- and extravascular compartments is reached after approximately three to five days.
Tinfirex relattivament malajr bejn il- plażma u l - fluwidu extravaskulari, u l- ekwilibriju bejn il- kompartimenti intra - u extravaskulari jintlaħaq wara madwar tlieta sa ħamest ijiem.
The pharmacokinetic parameters for Privigen were determined in a clinical study in PID patients (see section 5.1).
Il- parametri farmakokinetiċi għal Privigen kienu stabbiliti fi studju kliniku f’ pazjenti bil- PID (ara sezzjoni 5. 1).
Twenty-five patients (aged 13 to 69 years) participated in the pharmacokinetic assessment (see table below).
Ħamsa u għoxrin pazjent (li kellhom minn 13 sa 69 sena) ipparteċipaw fl- evalwazzjoni farmakokinetika (ara t- Tabella hawn taħt).
The median half-life of Privigen in primary immunodeficiency patients was 36.6 days.
Il- medjan tal- half- life ta ’ Privigen f’ pazjenti b’ immunodefiċjenza primarja kien ta ’ 36. 6 jiem.
This half-life may vary from patient to patient, particularly in primary immunodeficiency.
Din il- half- life tista ’ tvarja minn pazjent għall- ieħor, b’ mod partikulari f’ pazjenti b’ immunodefiċjenza primarja.
Pharmacokinetic parameters of Privigen in 25 PID patients
Parametri farmakokinetiċi ta ’ Privigen f’ 25 pazjent PID
Parameter Cmax (peak, g/l) Cmin (trough, g/l) t½ (days)
Parametru Cmax (massimu, g/ l) Cmin (minimu, g/ l) t½ (jiem)
Median (Range) 23.4 (10.4-34.6) 10.2 (5.8-14.7) 36.6 (20.6-96.6)
Medjan (Medda) 23. 4 (10. 4- 34. 6) 10. 2 (5. 8- 14. 7) 36. 6 (20. 6- 96. 6)
Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life
Cmax, konċentrazzjoni massima fis- serum; Cmin, l- inqas (livell minimu) konċentrazzjoni fis- serum; t½, half- life ta ’ l- eliminazzjoni
Immunoglobulins are a normal constituent of the human body.
L- immunoglobulini huma komponenti normali fil- ġisem tal- bniedem.
L-proline is a physiological, non- essential amino acid.
L- proline hu amino acid fiżjoloġiku, mhux essenzjali.
8 The safety of Privigen has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Is- sigurtà ta ’ Privigen kienet evalwata f’ diversi studji ta ’ qabel l- użu kliniku, b’ referenza partikulari għas- sustanza mhux attiva L- proline.
Some published studies pertaining to hyperprolinaemia have shown that long- term, high doses of L-proline have effects on brain development in very young rats.
Xi studji ppubblikati dwar l- iperprolinemija wrew li dożi qawwija u fit- tul ta ’ L- proline għandhom effetti fuq l- iżvilupp tal- moħħ f’ firien żgħar ħafna.
However, in studies where the dosing was designed to reflect the clinical indications for Privigen, no effects on brain development were observed.
Madankollu, fi studji fejn id- dożaġġ kien ippjanat biex jirrifletti l- indikazzjonijiet kliniċi għal Privigen, ma kienu osservati l- ebda effetti fuq l- iżvilupp tal- moħħ.
Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Informazzjoni li mhix klinika, ibbażata fuq studji dwar il- farmakoloġija tas- sigurtà u tat- tossiċità, ma turi l- ebda riskju speċjali għall - bnedmin.
6.1 List of excipients
TAGĦRIF FARMAĊEWTIKU
L-proline Water for injections
6. 1 Lista ta ’ sustanzi mhux attivi
6. 2 Incompatibilities
L- proline Ilma għall- injezzjonijiet
50 or 100 ml of solution in a single vial (type I or II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
50 jew 100 ml ta ’ soluzzjoni f’ kunjett wieħed (ħġieġ ta ’ tip I jew II), b’ tapp (elastomeric), għatu (crimp ta ’ l- aluminju), diska flip off (plastik), tikketta b’ hanger integrat.
200 ml of solution in a single vial (type II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
200 ml ta ’ soluzzjoni f’ kunjett wieħed (ħġieġ ta ’ tip II), b’ tapp (elastomeric), għatu (crimp ta ’ l - aluminju), diska flip off (plastik), tikketta b’ hanger integrat.
1 vial.
1 kunjett.
Privigen comes as a ready-for-use solution in single-use vials.
Privigen jiġi bħala soluzzjoni lesta għall- użu f’ kunjetti li jintużaw darba biss.
The product should be at room or body temperature before use.
Il- prodott għandu jkun fit- temperatura tal- kamra jew tal- ġisem qabel l- użu.
A vented infusion line should be used for the administration of Privigen.
Għandu jintuża vented infusion line għall- għoti ta ’ Privigen.
Always pierce the stopper at its centre, within the marked area.
Dejjem taqqab it- tapp fin- nofs, fiż- żona mmarkata.
Do not use solutions that are cloudy or have particulate matter.
Tużax soluzzjonijiet li jkunu mċajprin jew li jkun fihom il- frak.
Once the vial has been entered under aseptic conditions, its contents should be used promptly.
Ġaladarba l- kunjett ikun taħt kundizzjonijiet asettiċi, il- kontenut għandu jintuża malajr.
Because the solution contains no preservative, Privigen should be infused as soon as possible.
Minħabba li s - soluzzjoni ma fiha l- ebda preservattiv, Privigen għandu jkun infuż malajr kemm jista jkun..
CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
CSL Behring GmbH Emil- von- Behring- Strasse 76 D- 35041 Marburg Il- Ġermanja
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
CONDITIONS OF THE MARKETING AUTHORISATION
10 Informazzjoni ddettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /
CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Switzerland
CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 L- Isvizzera
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 1. 0, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 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 dwar l- Immaniġġjar tar- Riskju Id- Detentur ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq irid ikun obbligat li jwettaq l- istudji u attivitajiet oħra ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif miftiehem f’ verżjoni 1. 3 tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP skond il- ftehim ma ’ 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- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess flimkien mar- Rapport Perijodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
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
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess • Meta jkun hemm informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jnaqqsu r- riskju • Fi żmien 60 jum minn meta jintlaħaq għan importanti (farmakoviġilanza jew tnaqqis tar- riskju) • Fuq talba tal- EMEA
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artikolu 114 ta ’ Direttiva 2001/ 83/ KE kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta ’ l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
OUTER BOX
KAXXA TA ’ BARRA
Privigen 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Privigen 100 mg/ ml soluzzjoni għall- infużjoni Immunoglobulina normali umana (IVIg)
One ml contains:
1 ml fih:
Human plasma protein.............100 mg IgG purity................................. ≥ 98% IgA.....................................≤ 0.025 mg
Proteina tal- plażma umana...... 100 mg Purità ta ’ IgG............................ ≥ 98% IgA..................................... ≤ 0. 025 mg
5 g/50 ml 10 g/100 ml 20 g/200 ml Will be placed in the upper right corner of the main face of the box to give total content and volume of the container
5 g/ 50 ml 10 g/ 100 ml 20 g/ 200 ml Għandha titpoġġa fil- kantuniera tal- lemin tan- naħa ta ’ fuq tal- wiċċ prinċipali tal- kaxxa biex tagħti l - kontenut u l- volum totali tal- kontenitur
L-proline, water for injections.
L- proline, ilma għal injezzjonijiet.
Solution for infusion (10%)
Soluzzjoni għall- infużjoni (10%)
Contains 1 vial.
Fih 1 kunjett.
For intravenous use only.
Għall- użu ġol- vini biss.
Marketing authorisation holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
CSL Behring GmbH D-35041 Marburg Germany
CSL Behring GmbH D- 35041 Marburg Il- Ġermanja
Justification for not including Braille accepted.
Ir- raġuni biex ma jkunx inkluż il- Braille hija aċċettata.
16 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
17 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Human plasma protein:
Proteina tal- plażma umana:
100 mg; IgG purity: ≥ 98%.
100 mg; IgG purità: ≥ 98%.
IgA: ≤ 0.025 mg.
IgA: ≤ 0. 025 mg.
5 g/50 ml 10 g/100 ml 20 g/200 ml Will be placed in the upper right corner of the label to give total content and volume of the container
5 g/ 50 ml 10 g/ 100 ml 20 g/ 200 ml Għandha titpoġġa fil- kantuniera tal- lemin tan- naħa ta ’ fuq tat- tikketta biex tagħti l- kontenut u l- volum totali tal- kontenitur
CSL Behring GmbH, D-35041 Marburg, Germany
CSL Behring GmbH, D- 35041 Marburg, Il- Ġermanja
Privigen 100 mg/ml (10%) solution for infusion Human normal immunoglobulin (IVIg)
Privigen 100 mg/ ml (10%) soluzzjoni għall- infużjoni Immunoglobulina normali umana (IVIg)
- If you have any further questions, ask your doctor or health care professional.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- professjonist fil- qasam tal- kura tas- saħħa.
please tell your doctor or health care professional.
imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek jew lil professjonist fil- qasam tal- kura tas- saħħa.
What Privigen is and what it is used for 2.
X’ inhu Privigen u għalxiex jintuża 2.
Before you receive Privigen 3.
Qabel ma tirċievi Privigen 3.
How to use Privigen 4.
Kif għandek tuża Privigen 4.
How to store Privigen 6.
Kif taħżen Privigen 6.
WHAT PRIVIGEN IS AND WHAT IT IS USED FOR
X’ INHU PRIVIGEN U GĦALXIEX JINTUŻA
What Privigen is
X’ inhu Privigen
Privigen is a ready-to-use solution for infusion.
Privigen hu soluzzjoni għall- infużjoni lesta għall- użu.
The solution contains special proteins, isolated from human blood plasma.
Is- soluzzjoni fiha proteini speċjali, iżolati mill - plażma tad- demm uman.
These proteins belong to the class of "immunoglobulins", also called antibodies.
Dawn il- proteini jappartjenu għall- klassi ta ’ "immunoglobulini", imsejħa wkoll antikorpi.
How Privigen works
Kif jaħdem Privigen
Antibodies are usually produced by our immune system and help the body to fight infections.
Normalment l- antikorpi huma magħmulin mis- sistema immuni tagħna u jgħinu lill- ġisem jiġġieled l - infezzjonijiet.
Certain diseases can cause severe disturbance of the immune system.
Ċertu mard jista ’ jikkawża disturb sever tas- sistema immuni.
Because of this, you may not have enough of your own antibodies or you may need additional antibodies.
Minħabba dan, int jista ’ ma jkollokx biżżejjed mill- antikorpi tiegħek stess, jew tkun teħtieġ antikorpi addizzjonali.
The antibodies which are given to you by Privigen can complement your own antibodies or substitute missing antibodies.
L- antikorpi li jingħatawlek minn Privigen, jistgħu jikkomplimentaw l- antikorpi tiegħek stess jew jissostitwixxu l - antikorpi neqsin.
The antibodies in Privigen are isolated from human blood plasma.
L- antikorpi fi Privigen huma iżolati mill- plażma tad- demm uman.
Therefore they work exactly as if they were your own antibodies.
Għalhekk, jaħdmu eżattament bħallikieku kienu l- antikorpi tiegħek stess.
Privigen can also reduce the symptoms in certain inflammatory disorders.
Privigen jista ’ jnaqqas wkoll is- sintomi ta ’ ċerti disturbi infjammatorji.
In these cases Privigen is regulating the malfunctioning immune system.
F’ dawn il- każijiet, Privigen ikun jirregola s- sistema immuni li ma tkunx qed taħdem sewwa.
However, these effects are not fully understood.
Madankollu, dawn l- effetti mhumiex mifhuma għal kollox.
What Privigen is used for
Għalxiex jintuża Privigen
Privigen is used in three different situations:
Privigen jintuża fi tliet sitwazzjonijiet differenti:
A) Treatment of patients with too few antibodies (replacement therapy).
A) Kura ta ’ pazjenti li għandhom ftit wisq antikorpi (terapija ta ’ sostituzzjoni).
There are three groups:
Hemm tliet gruppi:
Patients with an inborn lack of antibodies (primary immunodeficiency syndromes (PID)) such as: ● congenital agammaglobulinaemia or hypogammaglobulinaemia, ● common variable immunodeficiency, ● severe combined immunodeficiency, ● Wiskott Aldrich syndrome.
Pazjenti li twieldu b’ nuqqas ta ’ antikorpi (sindromi ta ’ immunodefiċjenza primarja (PID)) bħal: ● agammaglobulinemija jew ipogammaglobulinemija konġenitali, ● immunodefiċjenza varjabbli komuni, ● immunodefiċjenza kkombinata severa, ● is- sindrome ta ’ Wiskott Aldrich.
Children who suffer from inborn AIDS (Acquired Immunodeficiency Syndrome) and recurrent infections.
Tfal li jbatu mill- AIDS (Acquired Immunodeficiency Syndrome) sa mit- twelid, u jkollhom infezzjonijiet rikorrenti.
B) Treatment of patients with certain inflammatory disorders (immunomodulation).
B) Il- kura ta ’ pazjenti b’ ċerti disturbi infjammatorji (immunomodulazzjoni).
Patients who do not have enough blood platelets (immune thrombocytopenic purpura (ITP)) and ● who are at high risk of bleeding, ● will have a surgery in the near future.
Pazjenti li m’ għandhomx biżżejjed plejtlits fid- demm (purpura tromboċitopenika immuni (ITP)) u ● li huma f’ riskju għoli li jitilfu demm. ● li ser jagħmlu operazzjoni fil- ġejjieni qarib.
Patients with Guillain-Barré syndrome.
Pazjenti bis- sindrome ta ’ Guillain Barré.
This is an acute disease that is characterised by inflammation of the peripheral nerves that causes severe muscle weakness mainly in the legs and upper limbs.
Din hi marda akuta kkaratterizzata minn infjammazzjoni tan- nervituri periferali li tikkawża dgħjufija severa tal- muskoli, l- aktar fil- riġlejn u fid- dirgħajn.
Patients with Kawasaki disease.
Pazjenti bil- marda ta ’ Kawasaki.
This is an acute disease of primarily young children characterised by an inflammation of the blood vessels throughout the body.
Din hi marda akuta, l- aktar fi tfal żgħar, ikkaratterizzata minn infjammazzjoni tal- vini jew arterji tad- demm fil- ġisem kollu.
C) Treatment or prevention of infections after a bone marrow transplantation (allogeneic bone marrow transplantation).
Ċ) Il- kura jew prevenzjoni ta ’ infezzjonijiet wara trapjant tal- mudullun (trapjant alloġeneiku tal - mudullun).
BEFORE YOU RECEIVE PRIVIGEN
QABEL MA TIRĊIEVI PRIVIGEN
Please read this section carefully.
Jekk jogħġbok aqra din is- sezzjoni bl- attenzjoni.
The information given should be taken in to consideration by you and your doctor before you receive Privigen.
L- informazzjoni li qed tingħata għandha tkun ikkunsidrata minnek u mit- tabib tiegħek qabel ma tirċievi Privigen.
Privigen must not be used
Privigen m’ għandux jintuża
► If you are allergic (hypersensitive)
► Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva)
to human immunoglobulins, to any other ingredient of Privigen (for a complete list of ingredients see section 6 of this leaflet).
għal immunoglobulini umani, għal kwalunkwe ingredjent ieħor ta ’ Privigen (għal lista kompleta ta ’ ingredjenti ara sezzjoni 6 ta ’ dan il- fuljett).
Please tell your doctor or health care professional prior to treatment about any medicine or food which you have not well tolerated earlier.
Jekk jogħġbok għid lit- tabib tiegħek jew lill- professjonist fil- qasam tal- kura tas- saħħa qabel il- kura dwar kwalunkwe mediċina jew ikel li ma kinetx taqbel miegħek fil- passat.
have antibodies against immunoglobulins of the type IgA in your blood.
► Jekk għandek antikorpi kontra immunoglobulini tat- tip IgA fid- demm.
This is very rare and may occur if you do not have enough immunoglobulins of the type IgA in your blood.
Dan hu rari ħafna u jista ’ jseħħu jekk inti m’ għandekx biżżejjed immunoglobulini tat- tip IgA fid- demm.
Please tell your doctor or health care professional prior to treatment if you have an immunoglobulin type IgA deficiency. ► If you have too much of the amino acid proline in your blood (hyperprolinaemia).
Jekk jogħġbok għid lit- tabib tiegħek jew lill- professjonist fil- qasam tal- kura tas- saħħa qabel il- kura jekk taf li għandek defiċjenza ta ’ l- immunoglobulina tat- tip IgA. ► Jekk għandek wisq amino acid proline fid- demm tiegħek (iperprolinemija).
This is an extremely rare disorder.
Dan hu disturb estremament rari.
Only a few families with this disease are known worldwide.
Hu magħruf li ftit familji biss fid- dinja għandhom din il- marda.
Please tell your doctor or health care professional prior to treatment if you have too much proline in your blood.
Jekk jogħġbok għid lit- tabib tiegħek jew lill- professjonist fil- qasam tal- kura tas- saħħa qabel il- kura jekk għandek wisq proline fid- demm.
Take special care with Privigen
Oqgħod attent ħafna bi Privigen