FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving IVIg, there have been reports of acute non-cardiogenic pulmonary edema (Transfusion Related Acute Lung Injury, (TRALI) in patients administered IVIg (including KIOVIG).
Maltese: F'pazjenti li jirċievu IVIg, kien hemm rapporti ta' edima pulmonari akuta li mhix kardjoġenika (Ferita Akuta fil-Pulmun Relatata mat-Trasfużjoni, (TRALI - Transfusion Related Acute Lung Injury)) f'pazjenti li ngħataw IVIg (inkluż KIOVIG).
English: Patients with inborn lack of antibody production (primary immunodeficiency syndromes).
Maltese: Pazjenti li twieldu b'nuqqas ta' produzzjoni ta' antikorpi (sindromi ta' immunodefiċjenza primarja).
English: 2.26 1.70 to 2.60 2.09 1.78 to 2.65 2.17 1.99 to 2.44
Maltese: 2.26 1.70 sa 2.60 2.09 1.78 sa 2.65 2.17 1.99 sa 2.44
English: Adults (18 years or above) Median 95% CI* Median 95% CI Median 95% CI Terminal half-life (days) 41.3 20.2 to 86.8 45.1 27.3 to 89.3 31.9 29.6 to 36.1 Cmin (mg/dl)/(mg/kg) (trough level)
Maltese: Adulti (18-il sena jew aktar) Medjan 95% CI* Medjan 95% CI* Medjan 95% CI* Il-half-life terminali (jiem) 41.3 20.2 sa 86.
English: Anaemia, lymphadenopathy
Maltese: Anemija, limfadenopatija
English: It is recommended that during dilution the risk of microbial contamination is minimised.
Maltese: Huwa rrakkomandat li matul id-dilwizzjoni, ir-riskju ta' kontaminazzjoni mikrobika jiġi minimizzat.
English: Other medicines and KIOVIG
Maltese: Mediċini oħra u KIOVIG
English: Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kg BW/hr for 30 minutes.
Maltese: L-immunoglobulina normali umana għandha tingħata b'infużjoni ġol-vini b'rata inizjali ta' 0.5 ml/kg BW/siegħa għal 30 minuta.
English: Replacement therapy in secondary immunodeficiency
Maltese: Terapija tas-sostituzzjoni f'immunodefiċjenza sekondarja
English: Replacement therapy in primary immunodeficiency starting dose: 0.4-0.8 g/kg maintenance dose: 0.2-0.8 g/kg every 3-4 weeks to obtain IgG trough level of at least 5-6 g/l
Maltese: Terapija tas-sostituzzjoni f'immunodefiċjenza primarja doża tal-bidu: 0.4-0.8 g/kg doża ta' manteniment: 0.2-0.8 g/kg kull 3-4 ġimgħat biex tikseb IgG livell minimu ta' mill-inqas 5-6 g/l
English: KIOVIG belongs to a class of medications called immunoglobulins.
Maltese: KIOVIG jagħmel parti minn kategorija ta' mediċini msejħa immunoglobulini.
English: 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2-5 days
Maltese: 0.4 g/kg/jum f'jum 1, possibbilment ripetuta fi żmien 3 ijiem għal 2-5 ijiem
English: • monitoring for signs and symptoms of thrombosis
Maltese: • monitoraġġ għal sinjali u sintomi ta' trombożi
English: Cases of Transfusion Related Acute Lung Injury (TRALI).
Maltese: Ferita Akuta fil-Pulmun Relatata mat-Trasfużjoni (Transfusion Related Acute Lung Injury - TRALI)
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Maltese: Għandu distribuzzjoni ta' sottoklassijiet ta' l-immunoglobulin G proporzjonali sew għal dik fil-plażma nativa umana.
English: Marketing Authorisation Holder Takeda Manufacturing Austria AG Industriestrasse 67
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Takeda Manufacturing Austria AG Industriestrasse 67
English: Loop diuretics
Maltese: Dijuretiċi loop
English: Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown) have been observed with human normal immunoglobulin.
Maltese: Bl-immunoglobulina normali umana ġew osservati każijiet ta' meninġite asettika riversibbli u każijiet rari ta' reazzjonijiet kutaneji temporanji (inkluż lupus erythematosus tal-ġilda - frekwenza mhux magħrufa).
English: 2 g/kg in one dose in association with acetylsalicylic acid
Maltese: 2 g/kg f'doża waħda flimkien ma' acetylsalicylic acid
English: Contusion, pruritus, urticaria, dermatitis, erythema Common Angioedema, acute urticaria, cold sweat, photosensitivity reaction, night sweats, hyperhidrosis
Maltese: Kontużjoni, ħakk tal-ġilda, urtikarja, dermatite, eritema Komuni Anġjoedema, utikarja akuta, għaraq kiesaħ, reazzjoni ta' fotosensittività, għaraq bil-lejl, iperidrosi
English: Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB.
Maltese: Reazzjonijiet emolitiċi riversibbli kienu osservati f'pazjenti, speċjalment dawk bi gruppi tad-demm A,B, u AB.
English: The safety of KIOVIG has been demonstrated in several non-clinical studies.
Maltese: Is-sigurtà ta' KIOVIG intweriet f'bosta studji mhux kliniċi.
English: • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
Maltese: • Immunodefiċjenzi sekondarji (SID - secondary immunodeficiencies) f'pazjenti li jbatu minn infezzjonijiet severi jew rikorrenti, trattament antimikrobiku ineffettiv u falliment ta' antikorp speċifiku li tingħata prova tiegħu (PSAF - proven specific antibody failure)* jew livell ta' IgG fis-serum ta' <4 g/l.
English: IVIg products can contain blood group antibodies that may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis.
Maltese: Prodotti li fihom IVIg jista' jkun fihom antikorpi għal gruppi tad-demm li jistgħu jaġixxu bħala haemolysins u jikkaġunaw kisja in vivo ta' ċelluli tad-demm ħomor b'immunoglobulina, li tikkawża reazzjoni ta' antiglobulin pożittiva diretta (Coombs' test) u, rarament, emolisi.
English: KIOVIG 100 mg/ml solution for infusion Human normal immunoglobulin
Maltese: KIOVIG 100 mg/ml soluzzjoni għal infużjoni Immunoglobulina normali umana
English: Hypogammaglobulinaemia (<4 g/l) in patients after allogeneic haematopoietic stem cell transplantation
Maltese: Ipogammaglobulinemija (< 4 g/l) f' pazjenti wara trapjant ta' ċelluli staminali ematopoietiċi alloġeniċi
English: KIOVIG also contains certain antibodies that can prevent an infection with hepatitis A virus and parvovirus B19.
Maltese: KIOVIG fih ukoll ċerti antikorpi li jistgħu jimpedixxu infezzjoni b'vajrus ta' l-epatite A u parvovirus B19.
English: KIOVIG 100 mg/ml solution for infusion
Maltese: KIOVIG 100 mg/ml soluzzjoni għall-infużjoni
English: Below is a list of side effects reported with KIOVIG:
Maltese: Hawn taħt hawn lista ta' effetti sekondarji rrappurtati b'KIOVIG:
English: Treatment of patients with certain inflammatory disorders (immunomodulation).
Maltese: Trattament ta' pazjenti b'ċertu disturbi infjammatorji (immunomodulazzjoni).
English: Hypotension, deep vein thrombosis
Maltese: Pressjoni baxxa, trombożi tal-vini profondi
English: 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.
Maltese: 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.
English: In divided doses over 2-5 days
Maltese: F'dożi diviżi fuq 2-5 ijiem
English: Increase in serum creatinine level and/or acute renal failure have been observed.
Maltese: Ġew osservati żidiet fil-livell tal-kreatinina fis-serum u/jew indeboliment renali akut.
English: Bronchitis, common cold, low red blood cell count, swollen lymph glands, decreased appetite, difficulty in sleeping, anxiety, dizziness, migraine, numbness or tingling of the skin or of a limb, reduced sense of touch, eye inflammation, rapid heartbeat, flushing, cough, runny nose, chronic cough or wheezing (asthma), stuffy nose, sore throat, shortness of breath, diarrhoea, vomiting, abdominal pain, indigestion, contusion, itchingand hives, dermatitis, reddened skin, pain in your back, pain in your joints, pain in your arms or legs, muscle pain, muscle cramps, muscular weakness, chills, accumulation of fluid under the skin, influenza-like illness, pain or discomfort in the chest, lack of strength or feeling of weakness, indisposition, shaking chills.
Maltese: Bronkite, riħ, għadd baxx ta' ċelluli tad-demm ħomor, glandoli linfatiċi minfuħin, nuqqas ta' aptit, diffikultà biex torqod, anzjetà, sturdament, emigranja, tnemnim jew tingiż tal-ġilda jew ta' parti mid-dirgħajn jew riġlejn, tnaqqis fis-sens tal-mess, infjammazzjoni fl-għajnejn, taħbit tal-qalb mgħaġġel, fwawar, sogħla, imnieħer inixxi, sogħla kronika jew tħarħir (ażżma), imnieħer misdud, uġigħ fil-griżmejn, qtugħ ta' nifs, dijarea, rimettar, uġigħ addominali, indiġestjoni, kontużjoni, ħakk u urtikarja, dermatite, ġilda ħamra, uġigħ f'dahrek, uġigħ fil-ġogi, uġigħ f'dirgħajk u f'riġlejk, uġigħ fil-muskoli, bugħawwieġ fil-muskoli, dgħjufija muskolari, tertir ta' bard, akkumulazzjoni ta' fluwidu taħt il-ġilda, mard bħal dak tal-influwenza, uġigħ jew skonfort fis-sider, nuqqas ta' saħħa jew sensazzjoni ta' dgħjufija, indispożizzjoni, tregħid.
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Maltese: Immunoglobulina normali umana jikkonsisti prinċipalment fiha immunoglobulina G (IgG) b'firxa kbira ta' antikorpi kontra aġenti t'infezzjoni.
English: Haemolysis
Maltese: Pożoloġija
English: Summary of KIOVIG pharmacokinetic parameters
Maltese: Il-parametri farmakokinetiċi ta' KIOVIG fil-Qosor
English: Replacement therapy in primary immunodeficiency syndromes
Maltese: Terapija tas-sostituzzjoni f'sindromi ta' l-immunodefiċjenza primarja
English: 0.4 g/kg/d for 5 days
Maltese: 0.4 g/kg/jum 5 ijiem
English: Back pain, arthralgia, pain in extremity, myalgia, muscle spasms, muscular weakness
Maltese: Uġigħ fid-dahar, artralġja, uġigħ fl-estremitajiet, majalġja, spażmi muskolari, dgħjufija muskolari
English: 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.
Maltese: 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.
English: Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
Maltese: Immunodefiċjenzi sekondarji (SID - secondary immunodeficiencies) f'pazjenti li jbatu minn infezzjonijiet severi jew rikorrenti, trattament antimikrobiku ineffettiv u jew falliment ta' antikorp speċifiku li tingħata prova tiegħu (PSAF - proven specific antibody failure)* jew livell ta' IgG fis-serum ta' <4 g/l.
English: • Uncommon side effects (may affect up to 1 in 100 people):
Maltese: • Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100 persuna):
English: The tables presented below are according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabelli ppreżentati hawn taħt huma skont il-klassifikazzjoni tal-organi tas-sistema MedDRA (SOC u Livell ta' Terminu Ppreferut).
English: While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Maltese: Filwaqt li dawn ir-rapporti ta' disfunzjoni renali u insuffiċjenza renali akuta ġew assoċjati mal-użu ta' bosta mill-prodotti ta' IVIg liċenzjati li fihom diversi sustanzi mhux attivi bħal sucrose, glucose u maltose, dawk li fihom is-sucrose bħala stabilizzatur ammontaw għal sehem sproporzjonat tan-numru totali.
English: Multifocal Motor Neuropathy (MMN)
Maltese: Newropatija Multifokali tal-Moviment (MMN)
English: • who had tolerated previous treatment with human normal immunoglobulin
Maltese: • li ttolleraw it-trattament preċedenti b'immunoglobulini umani normali
English: This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days.
Maltese: Dan normalment iseħħ fi żmien sigħat jew jiem wara għoti ta' IVIg u jgħaddi b'mod spontanju fi żmien 7 sa 14-il jum.
English: • avoidance of concomitant use of loop diuretics (see 4.5).
Maltese: • li wieħed jevita l-użu fl-istess ħin ta' dijuretiċi loop (ara 4.5).
English: Chronic infection of the nose, fungal infections, various infections (of the nose and throat, kidney or bladder), sterile inflammation of the layers lining the brain, serious allergic reactions, disorder of the thyroid, excessive response to stimuli, memory impairment, difficulty in speaking, unusual taste in the mouth, impaired balance, involuntary trembling, eye pain or swelling, vertigo, fluid in middle ear, peripheral coldness, vein inflammation, ear and throat swelling, abdominal distension, rapid swelling of the skin, acute inflammation of the skin, cold sweat, increased reaction of the skin to sunlight, excessive sweating also during sleep, muscle twitching, excess of serum protein in the urine, chest tightness, feeling hot, burning sensation, swelling, increased rate of breathing, changes to blood test results.
Maltese: Infezzjoni kronika tal-imnieħer, infezzjonijiet fungali, infezzjonijiet varji (tal-imnieħer u gerżuma, kliewi jew bużżieqa tal-awrina), infjammazzjoni sterili tas-saffi li jiksu l-moħħ, reazzjonijiet allerġiċi serji, disturbi fit-tirojde, rispons eċċessivi għall-istimuli, indeboliment fil-memorja, diffikultà biex titkellem, togħma mhux tas-soltu fil-ħalq, indeboliment fil-bilanċ, rogħda involontarja, uġigħ jew nefħa fl-għajnejn, sturdament, fluwidu fil-parti tan-nofs tal-widna, kesħa periferali, infjammazzjoni fil-vini, nefħa fil-widnejn u fil-gerżuma, nefħa addominali, nefħa mgħaġġla tal-ġilda, infjammazzjoni akuta tal-ġilda, għaraq kiesaħ, żieda fir-reazzjoni tal-ġilda għax-xemx, għaraq eċċessiv anke waqt l-irqad, kontrazzjonijiet tal-muskoli, eċċċess ta' proteini tas-serum fl-awrina, tagħfis fis-sider, tħoss is-sħana, sensazzjoni ta' ħruq, nefħa, żieda fir-rata tat-teħid tan-nifs, tibdil fir-riżultati tat-testijiet tad-demm.
English: 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.
Maltese: 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.
English: • If dilution is required, 5% glucose solution is recommended.
Maltese: • Jekk ikun hemm bżonn ta' dilwizzjoni, hija rrakkomandata soluzzjoni ta' 5% ta' glucose.
English: 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 at 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspects.
Maltese: L-istabbilità waqt l-użu ta' KIOVIG wara dilwizzjoni b'soluzzjoni ta' glucose ta' 5% għal konċentrazzjoni finali ta' 50 mg/ml (5% immunoglobulina) ntweriet għal 21 jum f'temperatura ta' 2°C sa 8°C kif ukoll f'temperatura ta' 28°C sa 30°C; madankollu, dawn l-istudji ma nkludewx il-kontaminazzjoni mikrobika u l-aspetti tas-sigurtà.
English: There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including 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.
Maltese: Hemm evidenza klinika ta' assoċjazzjoni bejn l-għoti ta' IVIg u każijiet tromboemboliċi bħal infart mijokardijaku, inċident ċerebrali vaskulari (li jinkludi 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 f'pazjenti f'riskju.
English: Amnesia, dysarthria, dysgeusia, balance disorder, tremor
Maltese: Amnesija, disartrija, disgewsja, disturb fil-bilanċ, rogħda
English: Replacement therapy in adults, and children and adolescents (0-18 years) in:
Maltese: Terapija tas-sostituzzjoni f'persuni adulti, tfal u adolexxenti (li jkollhom minn 0 sa 18-il sena) f':
English: • If dilution to lower concentrations is required prior to infusion, KIOVIG may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5% immunoglobulin).
Maltese: • Jekk ikun hemm bżonn ta' dilwizzjoni għal konċentrazzjonijiet iktar baxxi qabel l-infużjoni, KIOVIG jista' jiġi dilwit b'soluzzjoni ta' 5% glucose għal konċentrazzjoni finali ta' 50 mg/ml (5% immunoglobulina).
English: 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.
Maltese: 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.
English: *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Maltese: *PSAF = falliment biex tinkiseb mill-inqas żieda doppja fit-titru tal-antikorp IgG għat-tilqima talpolysaccharide tal-pnewmokokki u t-tilqima ta' antiġen ta' polypeptide.
English: Anaphylaxis can develop in patients
Maltese: Infezzjonijiet u infestazzjonijiet
English: 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).
Maltese: 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).
English: Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS and recurrent bacterial infections
Maltese: Ipogammaglobulinemija u infezzjonijiet batterjali rikorrenti f'pazjenti b'lewkimja limfoċitika kronika, li fihom antibijotiċi profilattiċi ma jkunux irnexxew; ipogammaglobulinemija u infezzjonijiet batterjali rikorrenti fil-fażi plateau f'pazjenti b'majeloma multipla li ma rrispondewx għal immunizzazzjoni pnewmokokkali; AIDS konġenitali u infezzjonijiet batterjali rikorrenti
English: Starting dose: 2 g/kg given over 2-5 consecutive days.
Maltese: 2 g/kg diviżi fuq 2-5 ijiem konsekuttivi.
English: Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4 ).
Maltese: Doża eċċessiva tista' twassal għal 'fluid overload' u iperviskożità, b'mod partikolari f'pazjenti f'riskju, inkluż pazjenti anzjani jew pazjenti b'indeboliment kardijaku jew renali (ara sezzjoni 4.4).
English: • monitoring of serum creatinine levels
Maltese: • monitoraġġ tal-livelli tal-krejatinina fis-serum
English: Local reactions (e.g. infusion site pain/swelling/reaction/pruritus), pyrexia, fatigue
Maltese: Reazzjonijiet lokali (eż. uġigħ/nefħa/reazzjoni/ħakk fis-sit tal-infużjoni), deni, għeja
English: 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
Maltese: 0.4 g/kg/kuljum fuq perjodu ta' 5 ijiem (ripetizzjoni possibbli tad-dożaġġ f'każ ta' rkadar).
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandu jiġi implimentat trattament mediku standard għal xokk.
English: Starting dose 2g/kg maintenance dose 1g/kg
Maltese: 2 g/kg doża ta' manteniment:
English: Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see also Section 4.4).
Maltese: Rarament, anemija emolitika li teħtieġ trasfużjoni tista' tiżviluppa wara doża għolja ta' kura b'IVIg (ara wkoll Sezzjoni 4.4).
English: In divided doses over 2-5 days every 3 weeks over 1-2 days
Maltese: F'dożi diviżi fuq 2-5 ijiem kull 3 ġimgħat fuq 1-2 jiem
English: IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
Maltese: Il livelli minimi ta' IgG għandhom jitkejlu u jiġu evalwati flimkien mal-inċidenza ta' infezzjoni.
English: There are no theoretical or observed differences in the action of immunoglobulins in children compared to adults.
Maltese: Ma hemm ebda differenza teoretika jew osservata fl-azzjoni tal-immunoglobulini fit-tfal meta mqabbla mal-adulti.
English: Glycine Water for injections
Maltese: Glycine Ilma għall-injezzjonijiet
English: 0.2-0.4 g/kg every 3-4 weeks
Maltese: 0.2-0.4 g/kg kull 3-4 ġimgħat
English: Hypersensitivity reactions are rare.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva huma rari.
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (0.5 ml/kg BW/hr); - are carefully monitored for any symptoms throughout the infusion period.
Maltese: Il-komplikazzjonijiet potenzjali jistgħu spiss jiġu evitati billi jiġi żgurat li l-pazjenti: - ma jkunux sensittivi għall-immunoglobulina normali umana billi inizjalment il-prodott jiġi injettat bil-mod (0.5 ml/kg BW/siegħa); - jiġu monitorjati b'attenzjoni għal kwalunkwe sintomu tul il-perijodu ta' infużjoni kollu.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Thyroid disorder
Maltese: Disturbi psikjattriċi
English: 3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Maltese: 3, il-biċċa l-kbira mis-serje granuloċitika, u livelli għolja ta' proteina sa diversi mijiet ta' mg/dL.
English: • Common side effects (may affect up to 1 in 10 people):
Maltese: • Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10 persuni):
English: • KIOVIG should be infused intravenously at an initial rate of 0.5 ml/kg bodyweight/hour for 30 minutes.
Maltese: • KIOVIG għandu jingħata b'infużjoni ġol-vini b'rata inizjali ta' 0.5 ml/kg piż tal-ġisem/siegħa għal 30 minuta.
English: • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Maltese: • Poliradikulonewropatija bi ħsara fil-majlin infjammatorja kronika (CIDP - chronic inflammatory demyelinating polyradiculoneuropathy)
English: For safety with respect to transmissible agents, see section 4.4.
Maltese: Għal sigurtà fir-rigward ta' aġenti li jistgħu jiġu trasmessi, ara sezzjoni 4.4.
English: Information on the source material of KIOVIG
Maltese: X'fih KIOVIG
English: One ml contains:
Maltese: ml wieħed fih:
English: Nervous system disorders Transient ischemic attack, cerebral vascular accident
Maltese: Attakk iskemiku temporanju, inċident vaskulari ċerebrali
English: Infections and infestations Bronchitis, nasopharyngitis
Maltese: Disturbi gastro-intestinali Nawsja
English: If dilution is required, 5% glucose solution is recommended.
Maltese: Jekk ikun hemm bżonn ta' dilwizzjoni, hija rrakkomandata soluzzjoni ta' 5% ta' glucose.
English: • 0.8-1g/kg given on day one; this dose may be repeated once within 3 days
Maltese: • 0.8-1 g/kg mogħtija fl-ewwel jum; din id-doża tista' tiġi ripetuta darba fi żmien 3 ijiem
English: 0.2-0.4 g/kg every 3-4 weeks to obtain IgG trough level of at least 5-6 g/l
Maltese: 0.2-0.4 g/kg kull 3-4 ġimgħat biex tikseb IgG livell minimu ta' mill-inqas 5-6 g/l