qanastek/EMEA-V3 huggingface dataset:
Kiovig should not be used in people who may be hypersensitive (allergic) to human normal immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Kiovig ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall - immunoglobulina normali tal- bniedem jew għal kwalunkwe mill- ingredjenti l- oħra, jew fil- pazjenti allerġiċi għal tipi oħra ta 'immunoglobulina normalital- bniedem, speċjalment meta jkollhom defiċjenza (livelli baxxi ħafna) ta' immunoglobulina A (IgA) u jkollhom antikorpi kontra l- IgA.
Why has Kiovig been approved?
Għaliex ġie approvat Kiovig?
According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children.
Skond il- linji gwida attwali, il- mediċini li ntwerew li huma effikaċi fil- pazjenti bil- PID u fil- pazjenti bl- ITP jistgħu jiġu approvati wkoll għall- użu fit- trattament ta 'kull tip ta' immunodefiċjenza primarja, kif ukoll għal- livelli baxxi ta 'antikorpi minħabba kanċer tad- demm jew minħabba l- AIDS fit- tfal.
They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing a bone marrow transplant, without the need for specific studies in these diseases.
Jistgħu jiġu approvati wkoll għat- trattament ta 'pazjenti bis- sindromu ta' Guillain- Barré, pazjenti bil - marda ta 'Kawasaki u pazjenti li jkunu ħadu trapjant tal- mudullun, mingħajr il- ħtieġa għal studji speċifiċi għal dawn il- mardiet.
Therefore, the Committee for Medicinal Products for Human Use (CHMP) concluded that Kiovig’ s benefits are greater than its risks for patients who require IgG for replacement therapy, for immunomodulation or because of bone marrow transplantation.
Għalhekk, il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l - benefiċċji ta 'Kiovig huma akbar mir- riskji għal pazjenti li jkunu jeħtieġu l- IgG għat- terapija sostituttiva, għall- immunomodulazzjoni jew minħabba trapjant tal- mudullun.
The Committee recommended that Kiovig be given marketing authorisation.
Il- Kumitat irrakkomanda li Kiovag jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Kiovig:
Tagħrif ieħor dwar Kiovig:
The European Commission granted a marketing authorisation valid throughout the European Union for Kiovig to Baxter AG on 19 January 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Kiovig lil Baxter AG fid- 19 ta 'Jannar 2006.
The full EPAR summary can be found here.
Is- sommarju sħiħ ta 'l- EPAR għal jista' jiġi kkonsultat hawn.
EU number
Numru tal- proċedura ta ’ l- EMEA
Solution for infusion
Soluzzjoni għal infużjoni
Intravenous use
Jingħata fil- vini
1 vial
kunjett wieħed
KIOVIG 100 mg/ ml solution for infusion
KIOVIG 100 mg/ ml soluzzjoni għall- infużjoni
1 ml contains:
1 ml fih:
Human normal immunoglobulin (IVIg )……………... 100 mg* *corresponding to human protein content, of which at least 98% is IgG
Immunoglobulina normali umana (IVIg) ……………... 100 mg * * li tikkorrespondi għall- kontenut ta 'proteina umana, li għallinqas 98% tagħha huwa IgG
One vial of 10 ml contains:
Kunjett wieħed ta '10 ml fih:
1 g One vial of 25 ml contains:
1 g Kunjett wieħed ta '25 ml fih:
2.5 g One vial of 50 ml contains:
2. 5 g Kunjett wieħed ta '50 ml fih:
5 g One vial of 100 ml contains:
5 g Kunjett wieħed ta '100 ml fih:
10 g One vial of 200 ml contains:
10 g Kunjett wieħed ta '200 ml fih:
Distribution of IgG subclasses:
Distribuzzjoni tas- sottoklassijiet ta 'IgG:
IgG1 ≥ 56.9% IgG2 ≥ 26.6% IgG3 ≥ 3.4% IgG4 ≥ 1.7%
IgG1 ≥ 56. 9% IgG2 ≥ 26. 6% IgG3 ≥ 3. 4% IgG4 ≥ 1. 7%
Maximum immunoglobulin A (IgA) content:
Kontenut massimu ta 'immunoglobulina A (IgA):
0.14 milligram per ml.
0. 14- il milligramma għal kull ml.
Glycine For a full list of excipients, see section 6.1.
Glycine Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Solution for infusion The solution is clear or slightly opalescent and colourless or pale yellow.
Soluzzjoni għall- infużjoni Is- soluzzjoni hija ċara jew kemmxejn opalexxenti u bla kulur jew safra ċara.
Replacement therapy in Primary immunodeficiency syndromes such as: − congenital agammaglobulinaemia and hypogammaglobulinaemia − common variable immunodeficiency − severe combined immunodeficiency − Wiskott Aldrich syndrome
Terapija ta 'sostituzzjoni f' Sindromi ta 'immunodefiċjenza primarja bħal: − agammaglobulinimja u ipogammaglobulinimja konġenitali − immunodefiċjenza varjabbli komuni − immunodefiċjenza kombinata serja − is- sindromu ta' Wiskott Aldrich
Myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections.
Majeloma jew lewkimja limfatika kronika (CLL) b' ipogammaglobulinemija sekondarja serja u infezzjonijiet rikorrenti.
Children with congenital AIDS and recurrent infections.
Tfal b' AIDS konġenitali u infezzjonijiet rikorrenti.
2 − Guillain Barré syndrome − Kawasaki disease
2 Immunomodulazzjoni − Purpura tromboċitopenika idjopatika (ITP), fi tfal jew adulti b' riskju għoli ta 'fsada jew qabel kirurġija sabiex jiġi korreġut l- għadd ta' plejtlits. − Is- sindromu ta 'Guillain Barré − Il- marda ta' Kawasaki
Allogeneic bone marrow transplantation
Trapjant tal- mudullun ta 'l- għadam alloġeniku
The dose and dosage regimen are dependent on the indication.
Id- doża u l- programm ta ’ kors ta ’ kura jiddependu mill- indikazzjoni.
The following dosage regimens are given as a guideline.
F' terapija ta 'sostituzzjoni d- dożaġġ għandu mnejn kollu jiġi individwalizzat għal kull pazjent skond ir - rispons farmakokinetiku u kliniku. Il- programmi ta ’ korsijiet ta ’ kura li ġejjin huma mogħtija bħala linja gwida.
Replacement therapy in primary immunodeficiency syndromes The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4-6 g/ l.
Terapija ta 'sostituzzjoni f' sindromi ta' immunodefiċjenza primarja Il - programm ta ’ kors tal- kura għandu jilħaq livell minimu ta 'IgG (imkejjel qabel l- infużjoni li jmiss) ta' mill- inqas 4- 6 g/ l.
The recommended starting dose is 0.4-0.8 g/ kg body weight (BW) followed by at least 0.2 g/ kg BW every three weeks.
Ikun hemm bżonn bejn tlieta sa sitt xhur minn wara l- bidu tat- terapija sabiex ikun hemm ekwilibrazzjoni. Id- doża tal- bidu rakkomandata hija ta '0. 4- 0. 8 g/ kg tal- piż tal- ġisem (BW) segwita b' għallinqas 0. 2 g/ kg BW kull tliet ġimgħat.
The dose required to achieve a trough level of 6 g/ l is of the order of 0.2-0.8 g/ kg BW/ month.
Id- doża meħtieġa sabiex jintlaħaq livell minimu ta '6 g/ l hija fl- ordni ta' 0. 2- 0. 8 g/ kg BW/ xahar.
The dosage interval when steady state has been reached varies from 2 to 4 weeks.
L- intervall tad- dożaġġ meta tkun intlaħqet fażi stabbli fissa jvarja minn ġimgħatejn għal erba 'ġimgħat.
Trough levels should be measured in order to adjust the dose and dosage interval.
Il- livelli minimi għandhom jitkejjlu sabiex jiġu aġġustati kemm id- doża kif ukoll l- intervall tad- dożaġġ.
Replacement therapy in myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections; replacement therapy in children with congenital AIDS and recurrent infections The recommended dose is 0.2-0.4 g/ kg BW every three to four weeks.
Terapija ta 'sostituzzjoni f' majeloma jew lewkimja limfatika kronika (CLL) b' ipogammaglobulinemija sekondarja serja u infezzjonijiet rikorrenti; terapija ta 'sostituzzjoni fi tfal b' AIDS konġenitali u infezzjonijiet rikorrenti Id- doża rakkomandata hija ta' 0. 2- 0. 4 g/ kg BW kull tliet jew erba 'ġimgħat.
The treatment can be repeated if a relapse occurs.
Purpura tromboċitopenika idjopatika (ITP) Għat- trattament ta 'episodju akut, 0. 8- 1 g/ kg BW fl- ewwel jum, li tista' tiġi ripetuta darba fi żmien 3 ijiem, jew 0. 4 g/ kg BW kuljum għal jumejn sa ħamest ijiem. It- trattament jista 'jiġi ripetut jekk il- pazjent jirkadi.
Guillain Barré Syndrome 0.4 g/ kg BW/ day for 3 to 7 days.
Is- sindromu ta 'Guillain Barré 0. 4 g/ kg BW/ jum għal 3 sa 7 ijiem.
Patients should receive concomitant treatment with acetylsalicylic acid.
Il- marda ta 'Kawasaki 1. 6- 2. 0 g/ kg BW għandhom jingħataw f' dożi maqsumin fuq jumejn sa ħamest ijiem jew 2. 0 g/ kg BW bħala doża waħdanija. Il- pazjenti għandhom jirċievu trattament konkomittanti b’ acetylsalicylic acid.
Allogeneic Bone Marrow Transplantation Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.
Trapjant tal- Mudullun ta 'l- Għadam Alloġeniku It- trattament ta' l- immunoglobulina normali umana jista 'jintuża bħala parti mil- kors ta' kondizzjonament u wara t- trapjant.
For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored.
Għat- trattament ta 'infezzjonijiet u profilassi tal- marda "graft versus host", id- dożaġġ huwa mfassal individwalment.
The starting dose is normally 0.5 g/ kg BW/ week, starting seven days before transplantation and for up to 3 months after transplantation.
Id- doża tal- bidu hija normalment 0. 5 g/ kg BW/ ġimgħa, li tibda sebat ijiem qabel it- trapjant u sa 3 xhur wara t- trapjant.
In case of persistent lack of antibody production, dosage of 0.5 g/ kg BW/ month is recommended until the antibody level returns to normal.
Fil- każ ta 'nuqqas persistenti ta' produzzjoni ta 'antikorpi, id- dożaġġ ta' 0. 5 g/ kg BW/ xahar huwa rakkomandat sakemm il- livell ta 'antikorpi jmur lura għan- normal.
3
3 Ir- rakkomandazzjonijiet dwar id- dożi huma mogħtija fil- qosor fit- tabella li ġejja:
Frequency of injections
Frekwenza ta 'l- injezzjonijiet
Replacement therapy in primary
Terapija ta 'sostituzzjoni
immunodeficiency
f' immunodefiċjenza primarja
– 0.8 g/ kg BW - thereafter:
0. 4 – 0. 8 g/ kg BW - minn hemm 'il quddiem:
– 0.8 g/ kg BW
0. 2 – 0. 8 g/ kg BW
trough level of at least 4 – 6 g/ l
kull 2 – 4 ġimgħat biex jinkiseb livell minimu ta ’ IgG ta ’ mill- inqas 4 – 6 g/ l
Replacement therapy in secondary immunodeficiency
kull 3 – 4 ġimgħat biex jinkiseb
0.2
Terapija ta 'sostituzzjoni f' immunodefiċjenza sekondarja
– 0.4 g/ kg BW
0. 2 – 0. 4 g/ kg BW
every 3 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/ l
livell minimu ta ’ IgG ta ’ mill- inqas 4 – 6 g/ l
every 3 – 4 weeks
kull 3 – 4 ġimgħat Tfal bl- AIDS Immunomodulazzjoni:
0.8 – 1
0. 2 – 0. 4 g/ kg BW
g/ kg BW or
0. 8 – 1 g/ kg BW jew
on day 1, possibly repeated once within 3 days
f’ jum 1 possibilment ripetuta darba fi 3 ijiem
0.4 g/ kg BW/ d
0. 4 g/ kg BW/ d
for 2 – 5 days
għal 2 – 5 ijiem
Guillain Barré syndrome
Is- sindrome ta 'Guillain Barré
for 3 – 7 days
għal 3 – 7 ijiem
Kawasaki disease
Il- marda ta 'Kawasaki
1.6 – 2
– 2 g/ kg BW jew
in several doses for 2 – 5 days in association with acetylsalicylic acid
f' diversi dożi għal 2 – 5 ijiem flimkien ma 'acetylsalicylic acid
Allogeneic bone marrow transplantation:
Trapjant tal- mudullun ta 'l- għadam alloġeniku
2 g/ kg BW
2 g/ kg BW
in one dose in association with acetylsalicylic acid
f' doża waħda flimkien ma 'acetylsalicylic acid
Treatment of infections and prophylaxis of graft versus host disease
Trattament ta 'infezzjonijiet u profilassi tal- marda "graft versus host"
0.5 g/kg BW
0. 5 g/ kg BW
Persistent lack of antibody production
Nuqqas persistenti ta 'produzzjoni
every month until antibody levels return to normal
l- antikorpi jerġa ’ lura għan- normal
Method of administration
Metodu ta ’ amministrazzjoni
Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kg BW/hr for 30 minutes.
L- immunoglobulina normali umana għandha tingħata b' infużjoni ġol- vini b' rata inizjali ta '0. 5 ml/ kg BW/ siegħa għal 30 minuta.
If well tolerated, the rate of administration may gradually be increased to a maximum of 6 ml/kg BW/hr.
Jekk din tiġi ttollerata sewwa, ir- rata ta 'amministrazzjoni tista', bil- mod il- mod tiżdied għal massimu ta '6 ml/ kg BW/ siegħa.
Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr.
Informazzjoni klinika miksuba minn numru limitat ta 'pazjenti tindika wkoll li pazjenti adulti b' PID jistgħu jittolleraw rata ta' infużjoni ta 'mhux aktar minn 8 ml/ kg BW/ siegħa.
KIOVIG should only be administered intravenously.
KIOVIG jista 'jingħata biss minn ġol- vini.
Other routes of administration have not been evaluated.
Postijiet oħra mnejn jingħata għadhom ma ġewx evalwati.
If dilution prior to infusion is required, KIOVIG may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5% immunoglobulin).
Jekk ikun hemm bżonn ta 'dilwizzjoni qabel l- infużjoni, KIOVIG jista' jiġi dilwit b' soluzzjoni li ta ’ 5% glucose għal konċentrazzjoni finali ta '50 mg/ ml (5% immunoglobulina).
For details on dilution, see section 6.6.
Għal dettalji fuq id- dilwizzjoni, ara sezzjoni 6. 6.
Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Sensittività eċċessiva għal immunoglobulini omologi, b' mod speċjali f' każijiet rari ħafna ta 'defiċjenza ta' IgA meta l- pazjent ikollu antikorpi kontra IgA.
4 4.4 Special warnings and precautions for use
4 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Certain severe adverse reactions may be related to the rate of infusion.
Ċerti reazzjonijiet avversi serji jistgħu jkunu relatati mar- rata ta 'infużjoni.
The recommended infusion rate given under “4.2 Method of administration” must be closely followed.
Ir- rata ta 'infużjoni rakkomandata mogħtija taħt, “ 4. 2 Metodu ta' kif għandu jingħata ” għandha tiġi segwita mill- qrib.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Il- pazjenti għandhom jiġu monitorjati mill- qrib u osservati b' attenzjoni għal kwalunkwe sintomu li jista 'jkun hemm matul il- perijodu ta' infużjoni.
Certain adverse reactions may occur more frequently − in case of high rate of infusion − in patients with hypo- or agammaglobulinemia 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 frekwenti − fil- każ ta 'rata għolja ta' infużjoni − f' pazjenti b' ipo - jew agammaglobulinemija b ’ defiċjenza jew mingħajr defiċjenza ta 'IgA − f' pazjenti li jirċievu immunoglobulina normali umana għall- ewwel darba jew, f' każijiet rari, meta l- prodott ta' immunoglobulina normali umana jinbidel jew meta jkun hemm intervall twil mill- aħħar infużjoni.
True hypersensitivity reactions are rare.
Ir- reazzjonijiet veri ta 'sensittività eċċessiva huma rari.
They can occur in the very seldom cases of IgA deficiency with anti-IgA antibodies.
Jistgħu jseħħu f’ każijiet tassew rari 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.
F' każijiet rari, immunoglobulina normali umana tista 'twassal għal waqa' fil- pressjoni tad- demm b' reazzjoni anafilattika, anki f' pazjenti li kienu ttolleraw it- trattament preċedenti b' immunoglobulina normali umana.
Potential complications can often be avoided by ensuring − that patients are not sensitive to human normal immunoglobulin by first infusing the product slowly (0.01 ml/kg BW/min); − that patients are carefully monitored for any symptoms throughout the infusion period.
Il- komplikazzjonijiet potenzjali jistgħu spiss jiġu evitati billi jiġi żgurat − li l- pazjenti ma jkunux sensittivi għall- immunoglobulina normali umana billi għall- ewwel il - prodott jingħata bħala infużjoni bil- mod (0. 01 ml/ kg BW/ min); − li l- pazjenti jiġu monitorjati b' attenzjoni għal kwalunkwe sintomu tul il- perijodu ta 'infużjoni kollu.
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 the first hour after the first infusion, in order to detect potential adverse signs.
B' mod partikolari, dawk il- pazjenti li qatt ma jkunu ħadu l- immunoglobulina normali umana, pazjenti li nbidliyilhom il- kura minn prodott alternattiv ta 'IVIg jew meta jkun hemm intervall twil mill- aħħar infużjoni, għandhom jiġu monitorjati matul l- ewwel infużjoni u għall - ewwel siegħa wara l- ewwel infużjoni, sabiex jinkixfu sinjali avversi potenzjali.
All other patients should be observed for at least 20 minutes after administration.
Il- pazjenti l - oħra kollha għandhom jiġu osservati għal mill- inqas 20 minuta wara li jingħata l- prodott.
There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin.
Hemm evidenza klinika ta 'assoċjazzjoni bejn l- għoti ta' IVIg u każijiet tromboemboliċi bħal infart mijokardjali, puplesija, emboliżmu pulmonari u trombożi venuża profonda li huwa stmat li din hija relatata ma 'żieda relattiva fil- viskożità tad- demm permezz ta' influss qawwi ta 'immunoglobulina.
Caution should be exercised in prescribing and infusion of 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 hypovolemic patients, patients with diseases which increase blood viscosity.
Għandha tingħata attenzjoni meta tingħata preskrizzjoni għal IVIg u meta l- IVIg jingħata b' infużjoni f' pazjenti obeżi u f' pazjenti li diġa għandhom fatturi ta 'riskju għal każijiet trombotiċi bħal età avvanzata, pressjoni għolja, dijabete mellitus u passat mediku ta' mard vaskulari jew episodji trombotiċi, pazjenti b' disturbi trombofiliċi akkwistati jew li ntirtu, pazjenti b' perijodi ta 'immobilizzazzjoni, pazjenti ipovolemiċi serji, pazjenti b' mard li jżid il- viskożità tad- demm.
Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Ġew irrapportati każijiet ta 'insuffiċjenza renali akuta f' pazjenti li jirċievu terapija b' IVIg.
In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Fil- biċċa l- kbira tal- każijiet, il- fatturi ta 'riskju ġew identifikati, bħal insuffiċjenza renali pre- eżistenti, dijabete mellitus, ipovolemja, piż żejjed, prodotti mediċinali nefrotossiċi li jkunu qed jingħataw fl- istess ħin jew età akbar minn 65 sena.
In case of renal impairment, IVIg discontinuation should be considered.
Fil- każ ta 'indeboliment renali, għandu jitqies it- twaqqif tal- 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 stabilizer accounted for a disproportionate share of the total number.
Filwaqt li dawn ir- rapporti ta 'disfunzjoni renali u insuffiċjenza renali akuta ġew assoċjati ma' l- użu ta 'bosta mill- prodotti ta' IVIg liċenzjati, dawk li fihom is- sucrose bħala stabilizzatur ammontaw għal sehem sproporzjonat tan- numru totali.
In patients at risk, the use of IVIg products that do not contain sucrose may be considered.
F' pazjenti f' riskju, jista 'jitqies l- użu ta' prodotti tal- IVIg li ma fihomx is- sucrose.
In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
F' pazjenti f' riskju ta 'insuffiċjenza renali akuta jew ta' reazzjonijiet avversi tromboemboliċi, il- prodotti ta 'IVIg għandhom jingħataw bir- rata minima ta ’ infużjoni u doża prattikabbli.
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 tal- ħruġ ta' l- awrina − monitoraġġ tal- livelli ta 'kreatinina fis- serum
5 In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
5 − l- evitar ta 'użu konkomittanti ta' loop diuretics
The treatment required depends on the nature and severity of the adverse reaction.
It- trattament meħtieġ jiddependi fuq in- natura u s- severità tar- reazzjoni avversa.
In case of shock, standard medical treatment for shock should be implemented.
Fil- każ ta 'xokk, għandu jiġi implimentat trattament mediku standard għal xokk.
If dilution of KIOVIG to lower concentrations is required for patients suffering from diabetes mellitus, the use of 5% glucose solution for dilution may have to be reconsidered.
Jekk ikun hemm bżonn ta 'dilwizzjoni ta' KIOVIG għal konċentrazzjonijiet iktar baxxi għal pazjenti li jsofru minn dijabete mellitus, jista 'jkun hemm bżonn li l- użu ta' soluzzjoni ta 'glucose ta' 5% għal dilwizzjoni jerġa 'jitqies.
KIOVIG is made from human plasma.
KIOVIG huwa magħmul minn plażma umana.
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 inactivation/removal of viruses.
Miżuri standard għall- prevenzjoni ta 'infezzjonijiet li jirriżultaw mill- użu ta' prodotti mediċinali imħejjija minn demm uman jew mill- plażma umana jinkludu għażla ta 'donaturi, skrining ta' donazzjonijiet individwali u kollezzjoniet ta 'plażma għal markers speċifiċi ta' infezzjoni u l- inklużjoni ta 'passi effettivi fil- manifattura għall - inattivazzjoni/ tneħħija ta' viri.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded.
Minkejja dan, meta jingħataw prodotti mediċinali ppreparati minn demm uman jew plażma umana, il- possibbiltà li jiġu trasmessi aġenti ta 'infezzjoni ma tistax tiġi eskluża għal kollox.
This also applies to unknown or emerging viruses and other pathogens.
Dan japplika wkoll għal viri mhux magħrufa jew ġodda u patoġeni oħra.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Il- miżuri meħudin huma meqjusin effettivi għal viri enveloped bħal HIV, HBV u HCV, u għal viri li m’ humiex enveloped HAV u parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or Parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Teżisti esperjenza klinika ta 'serħan il- moħħ dwar in- nuqqas ta' trasmissjoni ta 'epatite A jew Parvovirus B19 permezz ta ’ immunoglobulini u huwa stmat ukoll li l- kontenut ta' antikorpi jagħmel kontribuzzjoni importanti għas- sigurtà virali.
It is strongly recommended that every time that KIOVIG 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.
Huwa rrakkomandat ferm li kull darba li KIOVIG jingħata lil pazjent, l- isem u n- numru tal- lott tal- prodott jiġu rreġistrati sabiex tinżamm rabta bejn il- pazjent u l- lott tal- prodott.
4.5 Interactions with other medicinal products and other forms of interactions
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 for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Vaċċini ta 'viri ħajjin attenwati L- għoti ta' l- immunoglobulin jista 'jfixkel għal perijodu ta' mill- anqas bejn 6 ġimgħat u sa 3 xhur, l - effikaċja ta 'vaċċini ta' viri ħajjin attenwati bħall- ħosba, rubella, gattone u variċella.
After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Wara l- għoti ta 'dan il- prodott, għandu jkun hemm intervall ta' 3 xhur qabel ma ssir tilqima b' vaċċini ta 'viri ħajjin attenwati.
In the case of measles, this impairment may persist for up to 1 year.
Fil- każ tal- ħosba, dan l- indeboliment jista 'jibqa' għaddej għal sena.
Therefore patients receiving measles vaccine should have their antibody status checked.
Għalhekk, il- pazjenti li jirċievu vaċċin ta 'kontra l- ħosba għandu jkollhom l- istatus ta' l- antikorpi tagħhom ikkontrollat.
Interference with serological testing After infusion of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.
Interferenza ma ’ testijiet seroloġiċi Wara l- infużjoni ta 'l- immunoglobulina, iż- żieda transitorja ta' l- antikorpi varji ttrasferiti b' mod passiv fid- demm tal- pazjenti tista 'twassal għal riżultati pożittivi qarrieqa f’ testijiet seroloġiċi.
Passive transmission of antibodies to erythrocyte antigens, e.g.
It- trasmissjoni passiva ta 'antikorpi għal antiġeni eritroċiti, eż.
A, B, D, may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs test).
A, B, D, tista 'tinterferixxi ma' xi testijiet seroloġiċi għal antikorpi ta 'ċelloli ħomor, eżempju t- test ta' l- antiglobulina (test ta ’ Coombs).
In case of dilution with a 5% glucose solution, the KIOVIG administration may interfere with determination of blood glucose levels.
Fil- każ ta 'dilwizzjoni b' soluzzjoni ta' glucose ta '5%, l- għoti ta' KIOVIG jista 'jinterferixxi mal - kalkolu tal- livelli ta' glucose fid- demm.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women and breast-feeding mothers.
Is- sigurtà ta 'dan il- prodott mediċinali sabiex jintuża fi tqala umana ma ġietx stabbilita fi provi kliniċi kkontrollati u għalhekk għandu jingħata biss b' attenzjoni lil nisa tqal u lill - ommijiet li jkunu qegħdin 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.
L- esperjenza klinika bl- immunoglobulini tissuġġerixxi li m' huma mistennija ebda effetti ta 'ħsara fuq it- tqala, fuq il- fetu u fuq it- tarbija li tkun għadha kif twieldet.
Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
6 L- immunoglobulini joħorġu fil- ħalib u jistgħu jikkontribwixxu għat- trasferiment ta 'antikorpi protettivi għat- tarbija li tkun għadha kif twieldet.
No effects on the ability to drive and use machines have been observed.
Ma ġie osservat l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
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.
B' immunoglobulina normali umana għal għoti ġol- vini, reazzjonijiet avversi bħal irjieħat, uġigħ ta 'ras, deni, rimettar, reazzjonijiet allerġiċi, nawsja, artralġia, pressjoni baxxa u uġigħ moderat fil- parti t' isfel tad- dahar jistgħu jseħħu okkażjonalment.
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.
F' każijiet rari, immunoglobulini normali umani jistgħu jikkawżaw waqa 'f' daqqa fil- pressjoni tad - demm u, f' każijiet iżolati, xokk anafilattiku, anki meta l- pazjent ma jkun wera ebda sensittività għal prodott qabel.
Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis, transient increases in liver transaminases and rare cases of transient cutaneous reactions have been observed with human normal immunoglobulin.
Bl- immunoglobulina normali umana ġew osservati każijiet ta 'meninġite asettika riversibbli, każijiet iżolati ta' anemija emolitika riversibbli / emoliżi, żidiet mhux permanenti fit- transaminases tal- fwied u każijiet rari ta 'reazzjonijiet kutaneji.
Increase in serum creatinine level and/or acute renal failure have been observed.
Ġew osservati żidiet fil- livell tal- kreatinina fis- serum u/ jew indeboliment renali akut.
Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thromboses.
Reazzjonijiet tromboemboliċi bħal infart mijokardjali, puplesija, emboliżmu pulmonari u trombożi venuża profonda.
Two clinical trials with KIOVIG were performed in primary immunodeficiency (PID) patients in Europe and the US.
Saru żewġ provi kliniċi b' KIOVIG f' pazjenti b' immunodefiċjenza primarja (PID) fl- Ewropa u fl- Istati Uniti.
In the European study, 22 subjects with hypo- and agammaglobulinemia received KIOVIG for about 6 months.
Fl- istudju Ewropew, 22 individwu b' ipo - jew agammaglobulinemija rċevew KIOVIG għal madwar 6 xhur.
The US clinical trial was performed with 61 subjects with PID, who received KIOVIG for about 12 months.
Il- prova klinika ta 'l- Istati Uniti saret b' 61 individwu b' PID, li rċevew KIOVIG għal madwar 12- il xahar.
In Europe, an additional clinical study in 23 patients with idiopathic thrombocytopenic purpura (ITP) was performed.
Fl- Ewropa, sar studju kliniku ieħor fuq 23 pazjent b' purpura tromboċitopenika idjopatika (ITP).
No serious adverse drug reaction (ADR) was observed during the studies, with the exception of two episodes of aseptic meningitis in one patient of the US PID study, which were deemed possibly related to the medicinal product.
Ebda reazzjoni avversa serja għal- mediċina (ADR) ma ġiet osservata tul l- istudji, bl - eċċezzjoni ta 'żewġ episodji ta' meninġite asettika f' pazjent wieħed ta 'l- istudju tal- PID ta' l- Istati Uniti, li tqiesu li setgħu kienu relatati mal- prodott mediċinali.
Most ADRs observed were mild to moderate in nature.
Ħafna mill- ADRs osservati kienu ta 'natura ħafifa għal moderata.
In the European and US PID studies the overall rate of ADRs per infusion was 0.27.
Fl- istudji tal- PID ta 'l- Ewropa u ta' l- Istati Uniti, ir- rata globali ta 'ADRs għal kull infużjoni kienet ta' 0. 27.
As expected due to the much higher dosage, the ADR rate per infusion was higher (0.49) in the ITP trial; 87.5% of these ADRs were assessed as mild.
Kif mistenni, minħabba d- doża ferm akbar, ir- rata ta 'ADR għal kull infużjoni kienet ogħla (0. 49) fil- prova ta' ITP; 87. 5% minn dawn l- ADRs ġew ivvalutati bħala ħfief.
The non-serious ADRs reported in the three studies are summarized and categorized according to the MedDRA System organ class and frequency in the table below.
L- ADRs mhux serji rrapportati fit- tliet studji huma mogħtija fil- qosor u kkategorizzati skond is- Sistema tal- klassifika ta ’ l- organi tal - MedDRA u l- frekwenza fit- tabella hawn taħt.
Frequency has been evaluated using the following criteria: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Il- frekwenza ġiet evalwata permezz tal- kriterji li ġejjin: komuni ħafna (> 1/ 10), komuni (> 1/ 100, sa < 1/ 10), mhux komuni (> 1/ 1, 000 sa < 1/ 100), rari (> 1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħrufa (ma jistax jiġi stmat mid- dejta disponibbli).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F' kull sezzjoni tal- frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom.
7 Frequency of adverse drug reactions (ADRs) in clinical studies with KIOVIG
7 Frekwenza ta 'reazzjonijiet avversi tal- mediċina (ADRs) fi studji kliniċi b' KIOVIG
MedDRA preferred term
Terminu preferut ta 'MedDRA
ADR frequency
tal- frekwenza
system organ class
tal- klassifika ta ’ l- organi
category
ta 'ADR
Body temperature increased Blood cholesterol increased, blood creatinine increased, blood urea increased, haematocrit decreased, red blood cell count decreased, respiratory rate increased, white blood cell count decreased
Żieda fit- temperatura tal- ġisem Il- kolesterol fid- demm ogħla, żieda fil- kreatinina fid - demm, żdieda fil- urea fid- demm, tnaqqis fl- ematokrit, tnaqqis fl- għadd taċ- ċelloli tad- demm ħomor, żieda fir - rata respiratorja, tnaqqis fl- għadd taċ- ċelloli tad- demm bojod.
Tachycardia Anaemia, lymphadenopathy
Takikardja Anemija, limfadenopatija
Nervous system disorders
Mard tas- sistema nervuża
Headache Dizziness, migraine Amnesia, burning sensation, dysarthria, dysgeusia, insomnia
Uġigħ ta 'ras Sturdament, emigranja Amnesija, sensazzjoni ta' ħruq, disartrija, disgewsja, nuqqas ta 'rqad
Eye disorders
Disturbi fl- għajnejn Disturbi fil- widnejn u fis- sistema labrintika Disturbi respiratorji, toraċiċi u medjastinali
Conjunctivitis, eye pain, eye swelling
Konġuntivite, uġigħ fl- għajn, nefħa ta 'l- għajn Sturdament Fluwidu fil- parti tan- nofs tal- widna Sogħla, rinorea Ażżma, konġestjoni fl- imnieħer, nefħa orofarinġali, uġigħ faringolarinġali
Uncommon
Mhux komuni Komuni Mhux komuni Komuni Mhux komuni
Ear and labyrinth disorders Vertigo Fluid in middle ear Respiratory, thoracic and Cough, rhinorrhoea mediastinal disorders Asthma, nasal congestion, oropharyngeal swelling, pharyngolaryngeal pain
Disturbi gastro- intestinali Disturbi fil- ġilda u fit- tessuti taħta
Common Uncommon Common Uncommon
Komuni Komuni Mhux komuni
Gastrointestinal disorders Diarrhoea, nausea, vomiting Skin and subcutaneous Pruritus, rash, urticaria tissue disorders Angioneurotic oedema, acute urticaria, cold sweat, contusion, dermatitis, erythematous rash, pruritic rash
Disturbi muskolu- skeltrali u tal- connective tissue Disturbi fis- sistema endokrinarja
Common Common Uncommon
Komuni Mhux komuni Mhux komuni
Common Uncommon Uncommon Common Uncommon
Infezzjonijiet u infestazzjonijiet
Vascular disorders Flushing, hypertension Peripheral coldness, phlebitis General disorders and Pyrexia administration site Fatigue, influenza-like illness, infusion site pain, conditions infusion site swelling, rigors
Bronkite, nasofarinġite Sinusite kronika, infezzjoni fungali, infezzjoni, infezzjoni tal- kliewi, sinusite, infezzjoni fil- parti ta 'fuq tas- sistema respiratorja, infezzjoni fis- sistema ta' l- awrina, infezzjoni batterjoloġika fis- sistema ta 'l- awrina
Common Uncommon Very common Common
Komuni Mhux komuni
Application site pruritus, chest tightness, feeling hot, infusion site phlebitis, infusion site reaction, infusion site tenderness, malaise, peripheral oedema, swelling
Fwawar, pressjoni għolja Kesħa fl- estremitajiet, flebite
Uncommon
Komuni Mhux komuni
Psychiatric disorders Anxiety
Disturbi ġenerali u
Uncommon
Komuni ħafna
For safety with respect to transmissible agents, see section 4.4.
kundizzjonijiet ta 'mnejn jittieħed
4.9 Overdose
Ansjetà Mhux komuni
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.
aġenti li jistgħu jiġu trasmessi, ara sezzjoni 4. 4.
8 5.
8 4. 9 Doża eċċessiva
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code:
Kategorija farmakoterapewtika: sera immuni u immunoglobulini: immunoglobulini, umani normali, għal teħid intravaskulari, Kodiċi ATC:
Human normal immunoglobulin contains mainly functionally intact immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Immunoglobulina normali umana jikkonsisti prinċipalment fiha immunoglobulina G (IgG) funzjonalment intatt b' firxa kbira ta 'antikorpi kontra aġenti t' infezzjoni.
Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Immunoglobulina normali umana fiha l- antikorpi IgG preżenti fil- popolazzjoni normali.
It is usually prepared from pooled plasma from not fewer than 1000 donations.
Normalment jitħejja minn plażma miġbura minn mhux inqas minn 1000 donazzjoni.
It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Għandu distribuzzjoni ta 'sottoklassijiet ta' l- immunoglobulin G proporzjonali sew għal dik fil- plażma nativa umana.
Adequate doses of human normal immunoglobulin may restore abnormally low immunoglobulin G levels to the normal range.
Dożi adegwati ta 'immunoglobulina normali umana jistgħu jgħollu l- livelli baxxi mhux normali ta' l- immunoglobulin G għall- medda normali.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Il- mekkaniżmu ta 'l- azzjoni fl- indikazzjonijiet għajr f’ terapija ta' sostituzzjoni għadu ma ġiex imfisser għal kollox, iżda jinkludi effetti immunomodulatorji.
Human normal immunoglobulin is immediately and completely bioavailable in the recipient’s circulation after intravenous administration.
Immunoglobulina normali umana tkun bijodisponibbli minnufih u għal kollox fiċ- ċirkolazzjoni tar- riċevitur wara l- għoti ġol- vina.
It is distributed relatively rapidly between plasma and extravascular fluid; after approximately 3 to 5 days equilibrium is reached between the intra- and extravascular compartments.
Tinfirex relattivament malajr bejn il- plażma u l- fluwidu ekstravaskulari; wara bejn wieħed u ieħor 3 sa 5 ijiem, jintlaħaq ekwilibriju bejn kompartimenti intra - u ekstravaskulari.
The median IgG half-life after administration of KIOVIG was 32.5 days.
Parametri farmakokinetiċi għal KIOVIG ġew stabbiliti fiż- żewġ studji kliniċi li saru fl- Ewropa u l - Istati Uniti f’ pazjenti b’ PID. F' dawn l- istudji, total ta '83 individwu ta ’ sentejn jew akbar ġew trattati b' dożi ta' 300 sa 600 mg/ kg piż tal- ġisem kull 21 sa 28 jum għal 6 sa 12- il xahar. Il- half life medjana ta 'IgG wara l- għoti ta' KIOVIG kienet ta '32. 5 ġranet.
The values obtained in the studies are comparable to parameters reported for other human immunoglobulins.
Din il- half- life tista 'tvarja minn pazjent għal ieħor, b' mod partikolari f' immunodefiċjenza primarja. Il- parametri farmakokinetiċi għall- prodott huma mogħtija fil- qosor fit- tabella t' hawn taħt. Il- paramteri kollha ġew analizzati separatament għal tliet gruppi t' età, tfal (taħt it- 12- il sena, n=5), adoloxxenti (13 sa 17- il sena, n=10), u adulti (akbar minn 18 - il sena, n=64). Il- valuri miksubin fl- istudji huma komparabbli mal- parametri rrapportati għal immunoglobulini umani oħra.
Summary of KIOVIG pharmacokinetic parameters
9 Il- parametri farmakokinetiċi ta 'KIOVIG fil- Qosor
Adolescents
Adoloxxenti
(12 years or below) Median 95% CI* Median 20.2 to
(12- il sena jew inqas)
(13 to 17 years) 95% CI 27.3 to
(13 sa 17- il sena)
(18 years or above) Median 95% CI
(18- il sena jew aktar)
Terminal half-life (days)
Medjan 95% CI * Medjan 95% CI * Medjan 95% CI * Il- half- life terminali
41.3
20. 2 sa
86.8
27. 3 sa
45.1
(jiem) Cmin (mg/ dl) / (mg/ kg)
31.9
86. 8 1. 72 sa
Cmin (mg/dl)/(mg/kg)
89. 3 1. 98 sa
1.98 to
29. 6 sa 36. 1
(trough level) Cmax (mg/dl)/(mg/kg)
(livell minimu) Cmax (mg/ dl) / (mg/ kg)
2.74 3.30 to
2. 74 3. 30 sa
2.64 3.78 to
2. 64 3. 78 sa
1.92 to 2.43
1. 92 sa 2. 43
(peak level)
(l- ogħla livell)
5.16
5. 16
3.99 to 4.78
3. 99 sa 4. 78
In-vivo recovery (%) Incremental recovery
Irkupru in- vivo (%) Irkupru inkrimentali
87 to 137 1.70 to
87 sa 137 1. 70 sa
75 to 121 1.78 to
75 sa 121 1. 78 sa
96 to 114
96 sa 114
(mg/dl)/(mg/kg) AUC0-21d (g·h/dl) (area
(mg/ dl) / (mg/ kg) AUC0- 21d (g· h/ dl) (erja
2.60 1.34 to
2. 60 1. 34 sa
2.65 1.45 to
2. 65 1. 45 sa
1.99 to 2.44
1. 99 sa 2. 44
under the curve) *CI – Confidence Interval
taħt il- kurva) * CI – Intervall ta 'Kunfidenza
2.19
2. 19
1.50 to 1.78
1. 50 sa 1. 78
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
IgG u IgG- complexes jitkissru f' ċelloli tas- sistema retikuloendoteljali.
Immunoglobulins are normal constituents of the human body.
L- immunoglobulini huma kostitwenti normali tal- ġisem uman.
The safety of KIOVIG has been demonstrated in several non-clinical studies.
Is- sigurtà ta 'KIOVIG intweriet f' bosta studji mhux kliniċi.
Non-clinical data reveal no special risk for humans based on conventional studies of safety pharmacology and toxicity.
Informazzjoni li m’ hijiex klinika bbażata fuq studji konvenzjonali ta ’ sigurtà farmakoloġika u tossiċità ma turi l- ebda periklu speċjali għall- bnedmin.
Studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction in animals are impracticable due to induction of and interference by developing antibodies to heterologous proteins.
Studji dwar tossiċità ta 'doża ripetuta, ġenotossiċità, u tossiċità għar- riproduzzjoni fl- annimali mhumiex prattikabbli minħabba l- induzzjoni ta' u l- interferenza minn antikorpi li jkunu qegħdin jiżviluppaw għal proteini eteroloġiċi.
Since clinical experience provides no evidence for carcinogenic potential of immunoglobulins, no experimental studies in heterogeneous species were performed.
Minħabba li l- esperjenza klinika ma tipprovdi ebda evidenza ta 'potenzjal karċinoġeniku ta' l- immunoglobulini, ma sar ebda studju sperimentali fi speċi eteroġeniċi.
Glycine Water for injections
6. 1 Lista ta 'sustanzi mhux attivi
6.2 Incompatibilities
Glycine Ilma għall- injezzjonijiet
If dilution to lower concentrations is required, immediate use after dilution is recommended.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
The in- use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) immunoglobulin has been demonstrated for 21 days at 2°C to 8°C as well as 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspect.
Jekk ikun hemm bżonn ta 'dilwizzjoni għal konċentrazzjonijiet aktar baxxi, huwa rrakkomandat użu minnufih wara d- dilwizzjoni. L- istabbilità waqt l- użu ta' KIOVIG wara dilwizzjoni b' soluzzjoni ta 'glucose ta' 5% għal konċentrazzjoni finali ta '50 mg/ ml (5%) immunoglobulini ntweriet għal 21 jum f' 2°C sa 8°C kif ukoll fi 28°C sa 30°C; madankollu, dawn l- istudji ma inkludewx il- kontaminazzjoni mikrobika u l- aspett tas- sigurtà.
Keep the vial in the outer carton in order to protect from light.
10 Taħżinx f’ temperatura ’ l fuq minn 25°C Tagħmlux fil- friża Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
Once the product is stored at room temperature it must not be returned to the refrigerator and must be discarded, if not used by the end of the 9-month period.
Matul iż- żmien kemm idum tajjeb il- prodott, jista ’ jinħażen f' temperatura tal- kamra (mhux aktar minn 25°C) għal mhux aktar minn 9 xhur. Id- data ta 'trasferiment għal temperatura tal- kamra u t- tmiem tal - perijodu ta' 9 xhur għandhom jinkitbu fuq il- kartuna ta 'barra. Ladarba l- prodott ikun maħżun f' temperatura tal- kamra, m’ għandux jitpoġġa lura fil- friġġ u għandu jintrema, jekk ma jintużax sa tmiem il- perijodu ta' 9 xhur.
10, 25, 50, 100 or 200 ml of solution in a vial (Type I glass) with a stopper (bromobutyl).
10, 25, 50, 100, jew 200 ml ta 'soluzzjoni f' kunjett (ħġieġ ta' Tip I) b’ tapp (bromobutyl).
1 vial
Daqs tal- pakkett: kunjett wieħed
The product should be brought to room or body temperature before use.
Il- prodott għandu jilħaq it- temperatura tal- kamra jew tal- ġisem qabel ma jintuża.
10 If dilution is required, 5% glucose solution is recommended.
Jekk ikun hemm bżonn ta 'dilwizzjoni, hija rrakkomandata soluzzjoni ta' 5% ta 'glucose.
For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution.
Sabiex tinkiseb soluzzjoni ta 'immunoglobulina ta' 50 mg/ ml (5%), KIOVIG 100 mg/ ml (10%) għandu jiġi dilwit b' volum ugwali tas- soluzzjoni ta 'glucose.
It is recommended that during dilution the risk of microbial contamination is minimised.
Huwa rrakkomandat li matul id- dilwizzjoni, ir- riskju ta 'kontaminazzjoni mikrobika jiġi minimizzat.
Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.
Kull każ avvers relatat ma 'l- infużjoni għandu jiġi ttrattat billi jitbaxxew ir- rati ta' infużjoni jew billi l - infużjoni titwaqqaf għal kollox.
The product should be inspected visually for particulate matter and discolouration prior to administration.
Il- prodott għandu jiġi spezzjonat viżwalment għal frak u tifi fil- kulur tiegħu qabel ma ’ jingħata.
Do not use if particulate matter or discolouration is observed.
Tużahx jekk tosserva frak jew tifi fil- kulur tiegħu.
Only clear to slightly opalescent and colourless to pale yellow solutions are to be administered.
Soluzzjonijiet li huma ċari għal kemmxejn opalexxenti u bla kulur għal isfar ċar biss għandhom jingħataw.
KIOVIG should only be administered intravenously.
KIOVIG għandu jingħata biss minn ġol- vini.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. eu. int /: http: // www. emea. europa. eu /
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U D- DETENTUR TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦAL- ĦRUĠ TAL- LOTT
Baxter AG Industriestrasse 131 1221 Vienna Austria
Baxter AG Industriestrasse 131 1221 Vienna L- Awstrija
Via della Chimica 5l 0210 – S.Rufina/Cittaducale, Rieti Italy
Via della Chimica 5l 0210 – S. Rufina/ Cittaducale, Rieti L- Italja
Boulevard René Branquart 80 B-7860 Lessines Belgium
Boulevard René Branquart 80 B- 7860 Lessines Il- Belġju
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 uffiċjali tal- lott: b' mod konformi ma 'l- Artikolu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il - ħruġ uffiċjali tal- lott għandu jsir minn laboratorju statali jew minn laboratorju maħtur għal dak il- għan.
OUTER CARTON (1G, 2.5G, 5G, 10G AND 20G)
KARTUNA TA 'BARRA (IG, 2. 5G, 5G, 10G U 20G)
KIOVIG 100 mg/ml solution for infusion Human normal immunoglobulin
KIOVIG 100 mg/ ml soluzzjoni għall- infużjoni Immunoglobulina normali umana
Human protein, 100 mg/ml, at least 98% is IgG.
Proteina umana, 100 mg/ ml, għallinqas 98% huwa IgG.
Glycine Water for injections
Glycine Ilma għall- injezzjonijiet
Solution for infusion (10%) 1 g in 10 ml 2.5 g in 25 ml 5 g in 50 ml 10 g in 100 ml 20 g in 200 ml
Soluzzjoni għall- infużjoni (10%) 1 g f’ 10 ml 2. 5 g f’ 25 ml 5 g f’ 50 ml 10 g f’ 100 ml 20 g f’ 200 ml
Read the package leaflet before use.
Użu għal ġol- vini Aqra l- fuljett ta 'tagħrif qabel l- użu.
Date removed from refrigerator: __/__/_____ End of 9-month period at room temperature: __/__/_____
Data ta 'meta tneħħa mill- friġġ: __ / __ / _____ Tmiem tal- perijodu ta' 9 xhur f' temperatura tal- kamra: __ / __ / _____
Do not use after the expiry date printed on the carton.
Tużax wara d- data ta 'skadenza stampata fuq il- kaxxa.
Keep the container in the outer carton in order to protect from light.
Żomm ir- reċipjent fil- kaxxa tal- kartun sabiex tilqa ’ mid- dawl.