FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Ingelvac CircoFLEX:
Maltese: L-EPAR sħiħ għal Ingelvac CircoFLEX jinsab fis-sit web tal-Aġenzija:
English: These studies were performed under laboratory as well as under typical European farming conditions.
Maltese: Dawn l-istudji twettqu f'laboratorji kif ukoll taħt kundizzjonijiet ta' biedja Ewropea tipiċi.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac CircoFLEX's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Ingelvac CircoFLEX huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: For more information about treatment with Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Maltese: Il-provi wrew li t-tilqim tal-ħnieżer b'Ingelvac CircoFLEX naqqas it-telf fil-piż fil-qżieqeż.
English: It is not intended to provide practical advice on how to use Ingelvac CircoFLEX.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Ingelvac CircoFLEX.
English: Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds.
Maltese: Ingelvac CircoFLEX ġie studjat f'għadd ta' provi li involvew ħnieżer ta' diversi razez.
English: IgA ≤ 25 micrograms.
Maltese: IgA ≤ 25 mikrogramma.
English: t½ (days)
Maltese: t½ (jiem)
English: For instruction, see section 6.6.
Maltese: Għal istruzzjonijiet, ara sezzjoni 6.6.
English: MedDRA System Organ Class (SOC)
Maltese: Klassi tas-Sistemi u talOrgani ta' MedDRA (SOC)
English: Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
Maltese: Privigen hu isotoniku, b'osmolalità approssimattiva ta' 320 mOsmol/kg.
English: Human normal immunoglobulin 100 mg IgG purity ................................. ≥ 98% IgA ............................ ≤ 25 micrograms
Maltese: Immunoglobulin normali umana 100 mg Purità ta' IgG ............................ ≥ 98% IgA ........................ ≤ 25 mikrogramma
English: Cmax (peak, g/l) Cmin (trough, g/l)
Maltese: Cmax (massimu, g/l) Cmin (minimu, g/l)
English: Thromboembolic events, vasculitis (including peripheral vascular disorder)
Maltese: Avvenimenti tromboemboliċi, vaskulite (inkluż disturb vaskulari periferali)
English: EU/1/08/446/001 EU/1/08/446/002 EU/1/08/446/003 EU/1/08/446/004 EU/1/08/446/005 EU/1/08/446/006 EU/1/08/446/007
Maltese: EU/1/08/446/001 EU/1/08/446/002 EU/1/08/446/003 EU/1/08/446/004
English: Palpitations, tachycardia
Maltese: Palpitazzjonijiet, takikardija
English: Privigen contains proline
Maltese: Privigen fih proline
English: Incompatibilities
Maltese: Inkompatibbilitajiet
English: CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 Switzerland or
Maltese: CSL Behring AG Wankdorfstrasse 10, 3000 Bern 22 L-Iżvizzera jew
English: CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows, Vic 3047, Australia
Maltese: Pty Ltd 189-209 Camp Road Broadmeadows, Vic 3047, L-Awstralja
English: Frequencies were evaluated according to the following conventions: 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).
Maltese: 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).
English: Privigen does not contain sucrose, maltose or glucose.
Maltese: Privigen ma fihx sucrose, maltose jew glucose.
English: The two CIDP studies were performed with 28 and 207 patients, respectively.
Maltese: Iż-żewġ studji ta' CIDP saru bi 28 pazjent u 207 pazjenti, rispettivament.
English: Extension Study (N=13) ZLB05_006CR Median (Range)
Maltese: Studju ta' estensjoni (N=13) ZLB05_006CR Medjan (Medda)
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 28 November 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 25 April 2008 Data tal-ewwel tiġdid: 28 Novembru 2017
English: 1 vial (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml or 40 g/400 ml), 3 vials (10 g/100 ml or 20 g/200 ml).
Maltese: 1 kunjett (2.5 g/25 ml, 5 g/50 ml, 10 g/100 ml, 20 g/200 ml jew 40 g/400 ml), 3 kunjetti (10 g/100 ml jew 20 g/200 ml).
English: Dizziness (including vertigo)
Maltese: Sturdament (inkluż vertiġini)
English: Myalgia (including muscle spasms, musculoskeletal stiffness, musculoskeletal pain)
Maltese: Mijalġja (inkluż spażmi fil-muskoli, ebusija muskoluskeletrika, uġigħ muskoluskelettriku)
English: Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG.
Maltese: Privigen fih 100 mg/ml (10%) ta' proteina umana, li minnha, mill-inqas 98% hi IgG.
English: 12.3 (10.4-18.8) (3-week schedule) 9.4 (7.3-13.2) (4-week schedule)
Maltese: 12.3 (10.4-18.8) (skeda ta'
English: Human normal immunoglobulin (IVIg)*
Maltese: Immunoglobulina normali umana (IVIg)*
English: Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
Maltese: Emil-von-Behring-Strasse 76 D-35041 Marburg
English: Privigen is made from human plasma.
Maltese: Privigen huwa magħmul minn plażma umana.
English: Excipients with known effects: Privigen contains approximately 250 mmol/L (range: 210 to 290) of L-proline.
Maltese: Privigen fih madwar 250 mmol/L (medda: 210 sa 290) ta' L-proline.
English: Anisocytosis (including microcytosis), thrombocytosis
Maltese: Anisoċitożi (inkluż mikroċitożi), tromboċitożi
English: • The active substance is human normal immunoglobulin (antibodies of the type IgG).
Maltese: • Is-sustanza attiva hi immunoglobulina normali umana (antikorpi tat-tip IgG).
English: * PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Maltese: * PSAF = nuqqas li ttella' żieda ta' mill-inqas darbtejn fit-titre tal-antikorp IgG għal vaċċini ta' polysaccharide u polypeptide antigen pnewmokokkali.
English: Solution for infusion (10%)
Maltese: Soluzzjoni għall-infużjoni (10%)
English: It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Maltese: Tkun normalment ippreparata minn plażma miġbura minn mhux inqas minn 1000 donatur.
English: You will usually be observed during the whole infusion and for at least 20 minutes thereafter.
Maltese: Normalment, int ser tkun osservat mill-qrib matul l infużjoni kollha u għal mill-inqas 20 minuta wara.
English: Replacement therapy Primary immunodeficiency syndromes (PID)
Maltese: Terapija ta' sostituzzjoni Sindromi ta' immunodefiċjenza primarja (PID)
English: Human normal immunoglobulin 100 mg (purity of at least 98% IgG)
Maltese: Immunoglobulina normali umana 100 mg (purità ta' mill-inqas 98% IgG)
English: Anaemia, haemolysis (including haemolytic anaemia), leukopenia
Maltese: Anemija, emoliżi (inkluż anemija emolitika)
English: Monitor patients for pulmonary adverse reactions.
Maltese: Immonitorja l-pazjenti għal reazzjonijiet avversi fil-pulmuni.
English: CSL Behring BV Tel: +31 85 111 96 00
Maltese: CSL Behring B.V. Tel: + 31 85 111 96 00
English: Human normal immunoglobulin (IVIg)
Maltese: Immunoglobulina normali umana (IVIg)
English: CSL Behring GmbH, D-35041 Marburg, Germany
Maltese: CSL Behring GmbH, D-35041 Marburg, Il-Ġermanja
English: Guillain-Barré syndrome
Maltese: Sindrome ta' Guillain-Barré
English: EU/1/08/446/001 5 g/50 ml EU/1/08/446/002 10 g/100 ml EU/1/08/446/003 20 g/200 ml EU/1/08/446/004 2.5 g/25 ml EU/1/08/446/005 10 g/100 ml (3 vial pack size) EU/1/08/446/006 20 g/200 ml (3 vial pack size) EU/1/08/446/007 40 g/400 ml
Maltese: EU/1/08/446/005 10 g/100 ml (daqs tal-pakkett ta' 3 kunjetti) EU/1/08/446/006 20 g/200 ml (daqs tal-pakkett ta' 3 kunjetti) EU/1/08/446/007 40 g/400 ml
English: 771 infusions were administered and the median dose administered was 492.3 mg IgG/kg bw.
Maltese: Ingħataw 771 infużjoni u d-doża medjana mogħtija kienet ta' 492.3 mg IgG/kg bw.
English: The maximum IgA content is 25 micrograms/ml.
Maltese: Il-kontenut massimu ta' IgA hu ta' 25 mikrogramma/ml.
English: Which circumstances increase the risk of having side effects?
Maltese: Liema ċirkustanzi jżidu r-riskju li jkollok effetti sekondarji?
English: Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life
Maltese: Cmax, konċentrazzjoni massima fis-serum; Cmin, l-inqas (livell minimu) konċentrazzjoni fis-serum; t½,
English: In PRIMA, the percentage of responders in the overall Medical Research Council (MRC) score (defined as an increase by ≥ 3 points) was 85 % (87 % in the IVIg-untreated and 82 % in IVIgpretreated) and 57 % in PATH.
Maltese: (MRC, Medical Research Council) (ddefinit bħala żieda ta' ≥ 3 punti) kien 85 % (87 % f'dawk li ma kinux ġew ittrattati b'IVIg u 82 % f'dawk li qabel kienu ġew ittrattati b'IVIg) u 57 % f'PATH.
English: This is an extremely rare disorder.
Maltese: Dan hu disturb estremament rari.
English: Privigen 100 mg/ml solution for infusion
Maltese: Privigen 100 mg/ml soluzzjoni għall-infużjoni
English: CSL Behring SA Tél: +33 1 53 58 54 00
Maltese: Tél: + 33 1 53 58 54 00
English: Interference with serological testing
Maltese: Interferenza mal-ittestjar seroloġiku
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell antibodies, for example the direct antiglobulin test (DAT, direct Coombs' test).
Maltese: It-trasmissjoni passiva ta' antikorpi lil antiġeni eritroċiti, eż. A, B, D, tista' tfixkel xi testijiet seroloġiċi għal antikorpi taċ-ċelluli ħomor, pereżempju it-test dirett tal-antiglobulina (DAT, it-test dirett ta' Coombs).
English: Muscle strength as measured by the MRC (Medical Research Council) Score improved in all patients by 6.9 points (95% confidence interval [4.11, 9.75], in previously treated patients by 6.1 points (95% confidence interval [2.72, 9.44]) and in untreated patients by 7.7 points (95% confidence interval [2.89, 12.44]).
Maltese: Il-saħħa tal-muskoli kif imkejla mill-Punteġġ MRC (Kunsill dwar ir-Riċerka Medika) tjiebet fil pazjenti kollha b'6.9 punti (95% intervall ta' kunfidenza [4.11, 9.75], f'pazjenti kkurati fil-passat b'6.1 punti (95% intervall ta' kunfidenza [2.72, 9.44]) u f'pazjenti mhux ikkurati b'7.7 punti (95% intervall ta' kunfidenza [2.89, 12.44]).
English: Pharmacokinetic parameters of Privigen in PID patients Parameter
Maltese: Parametri farmakokinetiċi ta' Privigen f'pazjenti bil- PID
English: Privigen is essentially sodium free.
Maltese: Privigen essenzjalment ma fihx sodium.
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Maltese: sa 5 ijiem flimkien ma' acetylsalicylic acid
English: Primary immune thrombocytopenia (ITP)
Maltese: Tromboċitopenija immuna primarja (ITP)
English: By adjusted INCAT score, the responder rate by week 13 was 72.9 % (151 / 207 patients), with 149 patients responding already by week 10.
Maltese: Skont il-punteġġ aġġustat ta' INCAT, ir-rata ta' dawk li rrispondew sal-ġimgħa 13 kien 72.9 % (151 / 207 pazjenti), b'149 pazjent li kienu diġà rrispondew sa ġimgħa 10.
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)*
Maltese: Polinewropatija demajelinanti infjammatorja kronika (CIDP)*
English: Privigen belongs to the class of medicines called human normal immunoglobulins.
Maltese: Privigen jappartjeni għall-klassi ta' mediċini msejħa immunoglobulini normali umani.
English: The pharmacokinetic parameters for Privigen were determined in a clinical study in PID patients (see section 5.1).
Maltese: Il-parametri farmakokinetiċi għal Privigen kienu stabbiliti fi studju kliniku f'pazjenti bil-PID (ara sezzjoni 5.1).
English: Package leaflet: Information for the user Privigen 100 mg/ml (10%) solution for infusion
Maltese: Informazzjoni għall-utent Privigen 100 mg/ml (10%) soluzzjoni għall-infużjoni
English: For spontaneous post-marketing ADRs, the reporting frequency is categorized as unknown.
Maltese: Għal ADRs spontanji wara t-tqegħid fis-suq, il-frekwenza ta' rappurtar hija kkategorizzata bħala mhux magħrufa.
English: IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells (RBC) 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 taċ-ċelluli ħomor tad-demm (RBC) b'immunoglobulina, li tikkawża reazzjoni antiglobulina diretta pożittiva (test ta' Coomb) u, rarament, emolisi.
English: Patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies (PID)).
Maltese: Pazjenti li jitwieldu b'ħila mnaqqsa jew li ma jkunux kapaċi jipproduċu immunoglobulini (immunodefiċjenzi primarji (PID)).
English: IgG and IgG complexes are broken down in the cells of the reticuloendothelial system.
Maltese: Eliminazzjoni IgG u kumplessi IgG jitkissru fiċ-ċelluli tas-sistema retikuloendoteljali.
English: - Guillain-Barré syndrome.
Maltese: - Sindrome ta' Guillain Barré.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1 (ara wkoll sezzjoni 4.4)..
English: Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment including Privigen (see section 4.4).
Maltese: Rarament, anemija emolitika li teħtieġ trasfużjoni tista' tiżviluppa wara trattament b'doża għolja ta' IVIg inkluż bi Privigen (ara wkoll sezzjoni 4.4).
English: Tell your doctor if you are known to have medical problems.
Maltese: Għid lit-tabib tiegħek jekk inti taf li għandek problemi mediċi.
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 immunodeficiency) f'pazjenti li jsofru minn infezzjonijiet severi jew rikorrenti, trattament kontra l-mikrobi mhux effettiv u falliment ippruvat ta' antikorp speċifiku (PSAF - proven specific antibody failure)* jew IgG livell fisserum ta' <4 g/l.
English: In the pivotal PID study, 80 patients were enrolled and treated with Privigen.
Maltese: Fl-istudju ewlieni ta' PID, 80 pazjent kienu rreġistrati u ttrattati bi Privigen.
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 including Privigen.
Maltese: Il-każijiet ta' meninġite asettika riversibbli, u każijiet rari ta' reazzjonijiet temporanji tal-ġilda (inkluż eritematożu tal-lupus tal-ġilda - frekwenza mhux magħrufa) kienu osservati bl-immunoglobulina normali umana inkluż bi Privigen.
English: No differences were seen in the pharmacokinetic parameters between adult and paediatric study patients with PID.
Maltese: Ma kienu osservati l-ebda differenzi fil-parametri farmakokinetiċi bejn pazjenti adulti u pedjatriċi flistudju with PID.
English: It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Maltese: Tinfirex relattivament malajr bejn il-plażma u l-fluwidu extravaskulari, wara madwar 3-5 ijiem lekwilibriju jintlaħaq bejn il-kompartamenti intra u ekstravaskulari.
English: In a second prospective, multicenter randomized, placebo-controlled clinical study (Polyneuropathy and Treatment with Hizentra, PATH trial), 207 subjects with CIDP were treated with Privigen in the prerandomization phase of the study.
Maltese: Trattament b'Hizentra, prova PATH - Polyneuropathy and Treatment with Hizentra), 207 individwi b'CIDP ġew ittrattati bi Privigen fil-fażi tal-istudju qabel l-għażla arbitrarja.
English: Pivotal Study (N= 25) ZLB03_002CR Median (Range)
Maltese: ZLB03_002CR Medjan (Medda)
English: The MRC responder rate, an increase of at least 3 points, was 84.8% which was similar in previously treated (81.5% [58.95, 100.00]) and untreated (86.7% [69.46, 100.00]) patients.
Maltese: 8% li kienet simili f'pazjenti kkurati fil-passat (81.5% [58.95, 100.
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Maltese: L-immunoglobulina normali umana fiha biss immunoglobulina G (IgG) b'medda wiesgħa ta' antikorpi kontra organiżmi infettivi.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) and for the non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19.
Maltese: Il-miżuri meħuda huma kkunsidrati li huma effettivi għal viruses enveloped bħall-virus tal immunodefiċjenza umana (HIV), virus tal-epatite B (HBV) u virus tal-epatite C (HCV), u għallviruses non-enveloped bħal virus tal-epatite A (HAV) u parvovirus B19.
English: Uncommon (may occur with up to 1 in 100 patients):
Maltese: Mhux komuni (jistgħu jseħħu f'sa pazjent 1 minn kull 100):
English: Transfusion-related acute lung injury (TRALI)
Maltese: Ħsara akuta fil-pulmun marbuta mal-infużjoni (TRALI - Transfusion-related acute lung injury)
English: Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur CSL Behring GmbH
English: - Multifocal motor neuropathy (MMN)
Maltese: - Newropatija multifokali motorja (MMN - multifocal motor neuropathy)
English: Contains 3 vials.
Maltese: Fih 3 kunjetti.
English: 1038 infusions were administered, 272 (in 16 patients) in the 3-week schedule and 766 (in 64 patients) in the 4-week schedule.
Maltese: Ingħataw 1038 infużjoni, 272 (f'16-il pazjent) fl-iskeda ta' 3 ġimgħat u 766 (f'64 pazjent) fl-iskeda ta' 4 ġimgħat.
English: B) to treat certain inflammatory disorders (immunomodulation).
Maltese: B) biex tikkura ċerti disturbi infjammatorji (immunomodulazzjoni).
English: If dilution is desired, 5% glucose solution should be used.
Maltese: hi rrakkomandata soluzzjoni ta' 5% glucose.
English: There are two alternative treatment schedules:
Maltese: Hemm żewġ skedi alternattivi ta' kura:
English: Temporary lowering of red blood cell count (anaemia), breakdown of red blood cells (haemolysis), decreased number of white blood cells (leukopenia), hypersensitivity, dizziness (including vertigo), high blood pressure (hypertension), flushing (including hot flush, hyperaemia), hypotension (including decreased blood pressure), breathlessness (dyspnoea including chest pain, chest discomfort, painful breathing), vomiting, loose stools (diarrhea), stomach pain, skin disorder (including rash, itching (pruritus), hives (urticaria), maculopapular rash, redness of the skin (erythema), peeling of the skin (skin exfoliation)), pain in the muscles (including muscle cramps and rigidity), tiredness (fatigue), physical weakness (asthenia), weakness in the muscles, .
Maltese: Tnaqqis temporanju fl-għadd taċ-ċelluli ħomor tad-demm (anemija), diżintegrazzjoni taċ-ċelluli ħomor tad-demm (emoliżi), tnaqqis fin-numru ta' ċelluli bojod tad-demm (lewkopenija), sensittività eċċessiva, sturdament (inkluż vertigo), pressjoni tad-demm għolja (ipertensjoni), fwawar (inkluż fwawar sħan, iperimja), ipotensjoni (inkluż tnaqqis fil-pressjoni tad-demm), qtugħ ta' nifs (dispnea inkluż uġigħ fis-sider, skumdità fis-sider, uġigħ mat-teħid tan-nifs), rimettar, ippurgar maħlul (dijarea), uġigħ fl-istonku, disturb fil-ġilda (inkluż raxx, ħakk (prurite), ħorriqija (urtikarja), raxx makulopapulari, ħmura fil-ġilda (eritema), tqaxxir tal-ġilda (sfoljazzjoni tal-ġilda), uġigħ fil-muskoli
English: L-proline, water for injections.
Maltese: L-proline, ilma għall-injezzjonijiet.
English: B. PACKAGE LEAFLET
Maltese: Meninġite asettika
English: Additional measures of CIDP improvement were an increase in R-ODS (Rasch-built Overall Disability Scale) score of ≥ 4 points, a mean grip strength increase of ≥ 8 kPa, or an MRC sum score increase of ≥ 3 points.
Maltese: Miżuri addizzjonali ta' titjib ta' CIDP kienu żieda ta' ≥ 4 punti fil-punteġġ R-ODS (Rasch-built Overall Disability Scale), żieda medja ta' ≥ 8 kPa fil-qabda, jew żieda ta' ≥ 3 punti fil-punteġġ totali tal-MRC.
English: The approximate percentage of IgG subclasses is as follows:
Maltese: Distribuzzjoni tas-sottoklassijiet ta' IgG (valuri approssimattivi):
English: A total of 43 of the 207 patients achieved a better CIDP status as assessed by the adjusted INCAT score compared to their CIDP status at study entry.
Maltese: Total ta' 43 mill207 pazjenti kisbu stat aħjar ta' CIDP kif ivvalutat mill-punteġġ aġġustat ta' INCAT meta mqabbel mal-istat ta' CIDP tagħhom meta ddaħħlu fl-istudju.
English: Multifocal Motor Neuropathy (MMN)
Maltese: Newropatija Multifokali Motorja (MMN)
English: MRC sum score in PRIMA improved by 6.9 points (7.7 points for IVIg-untreated and 6.1 points for IVIg-pretreated) and by 3.6 points in PATH.
Maltese: Il-punteġġ totali tal-MRC fi PRIMA tjieb b'6.9 punti (7.7 punti għal dawk li ma kinux ġew ittrattati b'IVIg u 6.1 punti għal dawk li qabel kienu ġew ittrattati b'IVIg) u bi 3.6 punti f'PATH.
English: On the adjusted 10 point INCAT (Inflammatory Neuropathy Cause and Treatment) scale a clinically meaningful improvement of at least 1-point from baseline to treatment week 25 was observed in 17 out of 28 patients.
Maltese: INCAT (Kawża tan-Newropatija Infjammatorja u Kura) titjib b'sinifikat kliniku ta' mill-inqas punt wieħed mil-linja bażi sal-25 ġimgħa tal-kura kienet osservata fi 17 minn 28 pazjent.
English: Very rarely: Transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses.
Maltese: Ħsara akuta fil-pulmun marbuta mat-transfużjoni u reazzjonijiet tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari u trombożi profonda tal-vini.
English: TRALI may be managed using oxygen therapy with adequate ventilatory support.
Maltese: TRALI jista' jiġi mmaniġġjat bl-użu ta' terapija bl-ossiġnu b'sostenn ventilatorju adegwat.
English: In patients defined as INCAT non-responders, muscle strength improved by 5.5 points (95% confidence interval [0.6, 10.2]) as compared to INCAT responders (7.4 points (95% confidence interval [4.0, 11.7])
Maltese: (95% intervall ta' kunfidenza [0.6, 10.2]) meta mqabbla ma' persuni li rrispondew INCAT (7.4 punti (95% intervall ta' kunfidenza [4.0, 11.7]).
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Maltese: Kategorija farmakoterapewtika: sera immuni u immunoglobulini: immunoglobulini, normali umani,
English: IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern.
Maltese: IVIg mhux indikat f'pazjenti li għandhom defiċjenza IgA selettiva fejn id-defiċjenza IgA hi biss anormalità inkwetanti.
English: Six clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP.
Maltese: Saru sitt studji kliniċi bi Privigen, li kienu jinkludu pazjenti b'PID, ITP u CIDP.
English: • 0.8 to 1g/kg bw given on day 1; this dose may be repeated once within 3 days
Maltese: • 0.8 sa 1 g/kg piż tal-ġisem fl-1 jum; din id-doża tista' tkun ripetuta darba fi żmien 3 ijiem
English: Haemolysis has rarely been reported in patients given replacement therapy for PID.
Maltese: L-emolisi ġiet irrappurtata raramentf'pazjenti li jingħataw terapija ta' sostituzzjoni għal PID.
English: In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations:
Maltese: F'każijiet rari u iżolati, l-effetti sekondarji li ġejjin kienu rrappurtati bi preparazzjonijiet ta' l immunoglobulina: