FrancophonIA/ELRC3.0 huggingface dataset:
English: In the ITP pivotal study, in total 57 patients aged between 15 and 69 years old were treated with 2 infusions of Privigen for a total of 114 infusions.
Maltese: ITP, b'kollox 57 pazjent li kellhom bejn 15 u 69 sena kienu kkurati b'2 infużjonijiet ta' Privigen għal total ta' 114-il infużjoni.
English: 1 ml contains: Human normal immunoglobulin 100 mg. IgG purity ≥ 98%.
Maltese: 1 ml fih: Immunoglobulina normali umana 100 mg.
English: TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever.
Maltese: TRALI huwa kkaratterizzat minn distress respiratorju sever, edima filpulmun, ipoksemija, funzjoni normali tal-ventrikulu tan-naħa tax-xellug, u deni.
English: - Chronic inflammatory demyelinating polyneuropathy (CIDP).
Maltese: - Polinewropatija demajelinanti infjammatorja kronika (CIDP).
English: The in-use stability of Privigen after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) has been demonstrated for 10 days at 30°C; however, the microbial contamination aspect was not studied.
Maltese: L-istabbiltà waqt l-użu ta' Privigen wara dilwizzjoni b'soluzzjoni ta' 5% glucose għal konċentrazzjoni finali ta' 50 mg/ml (5%) intweriet għal għaxart ijiem f'temperatura ta' 30°C; madankollu, l-aspett tal-kontaminazzjoni bil-mikrobi ma ġiex studjat.
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' rabta bejn l-għoti ta' IVIg u avvenimenti tromboemboliċi bħal infart mijokardijaku, inċident vaskulari ċerebrali (inkluża puplesija), emboliżmu pulmonari u trombożi profonda tal-vini li hu maħsub li huma relatati ma' żieda relattiva fil-viskosità tad-demm minħabba linfluss qawwi ta' immunoglobulina f'pazjenti li qegħdin f'riskju.
English: 25 ml of solution in a single vial (type I glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih 25 ml ta' soluzzjoni f'kunjett wieħed (ħġieġ ta' tip I), b'tapp (elastomeric), għatu (crimp ta' l aluminju), diska flip off (plastik), tikketta mdendla integrate minn fuq.
English: It may happen particularly if you have developed antibodies against immunoglobulins of the type IgA.
Maltese: Jistgħu jiġru partikularment jekk tkun żviluppajt antikorpi kontra immunoglobulini tat-tip IgA.
English: The scheduled dose of 1 g/kg bw per infusion was closely adhered to in all patients (median 2 g IgG/kg bw).
Maltese: Id-doża skedata ta' 1 g/kg bw għal kull infużjoni kienet osservata b'attenzjoni fil-pazjenti kollha (medjan 2 g IgG/kg bw).
English: In the PID extension study, 55 patients were enrolled and treated with Privigen.
Maltese: Fl-istudju ta' estensjoni ta' PID, ġew irreġistrati 55 pazjent li ġew ittrattati bi Privigen.
English: Following clinical deterioration during IVIg withdrawal, clinical improvement of CIDP was primarily defined by a decrease of ≥ 1 point at the adjusted INCAT score.
Maltese: Wara deterjorament kliniku matul it-twaqqif ta' IVIg, titjib kliniku ta' CIDP kien iddefinit primarjament minn tnaqqis ta' ≥ 1 punt fil-punteġġ aġġustat ta' INCAT.
English: Patients with Guillain-Barré syndrome.
Maltese: Pazjenti bis-sindrome ta' Guillain Barré.
English: Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Maltese: Doża ta' manteniment: 1 g/kg kull 2 sa 4 ġimgħat jew 2 g/kg kull 4 sa 8 ġimgħat.
English: For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the 5% glucose solution.
Maltese: Biex tikseb soluzzjoni ta' immunoglobulina ta' 50 mg/ml (5%), Privigen 100 mg/ml (10%) għandu jiġi ddilwit b'volum ugwali ta' soluzzjoni ta' 5% glucose.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: Other medicines and Privigen
Maltese: Mediċini oħra u Privigen
English: Pack sizes:
Maltese: Eċċipjenti:
English: Human normal immunoglobulin should be infused intravenously at an initial infusion rate of 0.3 ml/kg bw/hr for approximately 30 min.
Maltese: L-immunoglobulina normali umana għandha tingħata bħala infużjoni minn ġol-vina b'rata inizjali ta' l-infużjoni ta' 0.3 ml/kg piż tal-ġisem/siegħa għal madwar 30 minuta.
English: Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.
Maltese: Sensittività eċċessiva għal immunoglobulini umani, speċjalment f'pazjenti b'antikorpi kontra
English: Privigen is intended solely for the infusion into a vein (intravenous infusion).
Maltese: Privigen hu intenzjonat biss għall-infużjoni ġo vina (infużjoni intravenuża).
English: Secondary immunodeficiencies (as defined in 4.1) The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Maltese: Immunodefiċenzi sekondarji (kif definit f'4.1) Id-doża rakkomandata hija ta' 0.2 - 0.4 g/kg kull tlieta sa erba' ġimgħat.
English: - Kawasaki disease.
Maltese: - Il-marda ta' Kawasaki.
English: starting dose: 0.4 - 0.8 g/kg bw maintenance dose: 0.2 - 0.8 g/kg bw every 3 to 4 weeks to obtain IgG trough levels of at least 5 - 6 g/l
Maltese: 0.2 - 0.8 g/kg piż tal-ġisem kull 3 sa 4 ġimgħat biex tikseb livell minimu ta' IgG ta' mill-inqas 5-6 g/l
English: The safety and efficacy of Privigen was evaluated in 6 prospective, open-label, single-arm, multicenter studies performed in Europe (ITP, PID and CIDP studies) and the USA (PID study).
Maltese: Is-sigurtà u l-effikaċja ta' Privigen kienu evalwati f'6 studji prospettivi, open-label, single-arm, multiċentriċi, li saru fl-Ewropa (studji
English: No differences were seen in the pharmacodynamic properties between adult and paediatric study patients.
Maltese: Ma kienu osservati l-ebda differenzi fil-kwalitajiet farmakodinamiċi bejn pazjenti adulti u pedjatriċi flistudju.
English: Common (may occur with up to 1 in 10 patients):
Maltese: Komuni (jistgħu jseħħu f'sa pazjent 1 minn kull 10):
English: The grip strength of the dominant hand improved by 14.1 kPa (17.0 kPa in IVIg-untreated and 10.8 kPa in IVIg pretreated subjects) in the PRIMA study, while in PATH the grip strength of the dominant hand improved by 12.2 kPa.
Maltese: Is-saħħa tal-qabda tal-id dominanti tjiebet b'14.1 kPa (17.0 kPa f'individwi li ma kinux ġew ittrattati b'IVIg u 10.
English: In this study, the median half-life of Privigen in PID patients was 36.6 days.
Maltese: F'dan l-istudju, il-medjan tal-half-life ta' Privigen f'pazjenti kien ta' 36.6 jiem.
English: For obtaining an immunoglobulin solution of 50 mg/ml (5%), Privigen 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution.
Maltese: Biex tikseb soluzzjoni ta' immunoglobulina ta' 50 mg/ml (5%), Privigen 100 mg/ml (10%) għandu jiġi ddilwit b'volum ugwali ta' soluzzjoni ta' glucose.
English: Renal and urinary disorders
Maltese: • insuffiċjenza renali akuta
English: Decreased haemoglobin (including decreased red blood cell count, decreased haematocrit), Coombs` (direct) test positive, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase
Maltese: Tnaqqis fl-emoglobina (inkluż tnaqqis fl-għadd taċ-ċelluli tad-demm ħomor, tnaqqis fl ematokrit), riżultat pożittiv għat-test (dirett) ta' Coombs, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fil-lactate dehydrogenase fid-demm
English: Hypersensitivity True hypersensitivity reactions are rare.
Maltese: Reazzjonijiet ta' sensittività eċċessiva vera huma rari.
English: Skin disorder (including rash, pruritus, urticaria, maculo-papular rash, erythema, skin exfoliation)
Maltese: Disturb fil-ġilda (inkluż raxx, ħakk, urtikarja,
English: If dilution prior to infusion is desired, Privigen may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5%).
Maltese: Jekk tixtieq tiddilwieh qabel l-infużjoni, Privigen jista' jiġi dilwit b'soluzzjoni ta' 5% glucose għal konċentrazzjoni finali ta' 50 mg/ml (5%).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: 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.
Maltese: Hemm esperjenza klinika inkoraġġanti dwar in-nuqqas ta' trasmissjoni ta' epatite A jew ta' parvovirus B19 permezz ta' l-immunoglobulini, u hu maħsub ukoll li l-kontenut ta' l-antikorpi għandu sehem importanti fis-sigurtà virali.
English: CSL Behring GmbH Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
Maltese: CSL Behring GmbH Emil-von-Behring-Strasse 76
English: Patients with hyperprolinaemia type I or II.
Maltese: Pazjenti b'iperprolinemija tat-tip I jew II .
English: 1.6 - 2 g/kg bw or in divided doses over 2 to 5 days in association with acetylsalicylic acid
Maltese: 1.6 - 2.0 g/kg piż tal-ġisem jew f'dożi li jinqasmu fuq perijodu ta' minn 2 sa 5 ijiem flimkien ma' acetylsalicylic acid
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus and parvovirus B19.
Maltese: Il-miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses enveloped bħall-virus ta' l immunodefiċjenza umana, il-virus ta' l-epatite B u l-virus ta' l-epatite Ċ u għall-viruses non-enveloped ta' l-epatite A u l-viruses B19.
English: You will recognize TRALI by severe difficulty in breathing (respiratory distress), abnormally low level of oxygen in the blood (hypoxemia), normal heart function (left ventricular function) and increased body temperature (fever).
Maltese: Inti tagħraf TRALI minn diffikultà severa biex-tieħu n-nifs (distress respiratorju), livell baxx b'mod mhux normali ta' ossiġnu fid-demm (ipoksemija), funzjoni normali tal-qalb (funzjoni tal-ventrikulu tax-xellug) u żieda fit temperatura tal-ġisem (deni).
English: • transient decrease in red blood cells (reversible haemolytic anaemia/haemolysis), anaemia, leukopenia, anisocytosis (including microcytosis).
Maltese: • tnaqqis temporanju ta' ċelluli ħomor tad-demm (anemija/emolisi emolitika riversibbli), anemija,
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Maltese: L-immunoglobulina normali umana hi immedjatament u kompletament bijodisponibbli fiċ ċirkolazzjoni tal-pazjent meta tingħata fil-vina.
English: Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Maltese: Dożi adegwati ta' dan il-prodott mediċinali jistgħu iżidu għan normal livelli baxxi ta' immunoglobulina G.
English: • In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Privigen.
Maltese: transfusion-related acute lung injury) wara li wieħed jirċievi immunoglobini inkluż Privigen.
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced RBC sequestration.
Maltese: Anemija emolitika tista' tiżviluppa wara terapija b'IVIg minħabba li tiffavorixxi sekwestrazzjoni ta' RBC.
English: 13 children (3 to 11 years), 8 adolescents (12 to 15 years) and 34 adults were treated with Privigen over 29 months.
Maltese: L-istudju ta' estensjoni ta' PID kien jinkludi total ta' 55 pazjent b'età bejn 4 snin u 81 sena. 13-il tifel u tifla (3 snin sa 11-il sena), 8 adolexxenti (12 sa 15-il sena) u 34 adult kienu kkurati bi Privigen fuq perijodu ta' 29 xahar.
English: Nausea
Maltese: Tilqim
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA(ĊI) ATTIVA U
English: • if you have developed antibodies against immunoglobulins of the type IgA in your blood.
Maltese: • jekk tkun żviluppajt antikorpi kontra immunoglobulini tat-tip IgA fid-demm.
English: Tel: +385 1 631 1833
Maltese: PharmaSwiss d.o.o. Tel: +385 1 631 1833
English: Flushing of the infusion tubes with physiological saline or 5% glucose solution is permitted.
Maltese: Flaxxjar tat-tubi ta' infużjoni bis-salina fiżjoloġika jew soluzzjoni ta' glucose 5% huwa permess.
English: Overall, in 42 subjects (74 %) the platelet count increased at least once to ≥ 50×109 / l within 6 days after the first infusion, which was well within the expected range.
Maltese: Globalment, fi 42 individwu (74 %) l-għadd tal-plejtlits żdied mill-inqas darba għal ≥ 50×109 / l fi żmien 6 ijiem wara l-ewwel infużjoni, li kien fil-medda mistennija b'mod konsiderevoli.
English: Do NOT take Privigen
Maltese: TIEĦUX Privigen
English: In subjects with platelet counts < 50×109 / l after the first dose, 30% showed a platelet response of ≥ 50×109 / l after the mandatory second dose.
Maltese: F'indivdiwi b'għadd tal-plejtlits ta' < 50×109 / l wara l-ewwel doża, 30% urew rispons tal-plejtlits ta' ≥ 50×109 / l wara t-tieni doża obbligatorja.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA(ĊI) ATTIVA U MANIFATTUR(I)
English: In most cases risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Maltese: Fil-biċċa l-kbira tal-każijiet ġew identifikati fatturi ta' riskju, bħal insuffiċjenza renali li kienet teżisti minn qabel, dijabete mellitus, ipovolimja, piż żejjed, prodotti mediċinali nefrotossiċi konkomitanti jew età aktar minn 65 sena.
English: Immunomodulation Primary immune thrombocytopenia (ITP) 0.8 - 1 g/kg bw or on day 1, possibly repeated once within 3 days
Maltese: 0.8 - 1.0 g/kg piż tal-ġisem Jew fl-1 jum, possibbilment ripetuta fi żmien 3 ijiem
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Maltese: Is-sindromu normalment jibda numru ta' sigħat sa 2 jumejn wara l-kura b'IVIg.
English: L-proline is a physiological, nonessential amino acid.
Maltese: L-proline hu amino acid fiżjoloġiku, mhux essenzjali.
English: For safety with respect to transmissible agents and additional details on risk factors, see section 4.4.
Maltese: Għal sigurtà rigward sustanzi li jistgħu jiġu trasmessi u dettalji addizjonali dwar fatturi ta' riskju, ara sezzjoni 4.4.
English: The following information is intended for healthcare professionals only:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Aseptic technique must be strictly observed during the dilution of Privigen.
Maltese: Teknika asettika trid tiġi osservata b'mod strett waqt id dilwizzjoni ta' Privigen.
English: The following table shows an overview of the ADRs observed in the six clinical studies categorized according the MedDRA System Organ Class (SOC), Preferred Term Level (PT) and frequency.
Maltese: It-tabella li jmiss tagħti deskrizzjoni fil-qosor tal-ADRs osservati fis-sitt studji kliniċi kkategorizzati skont il-Klassi tas-Sistemi u tal-Organi (SOC - System Organ Class) ta' MedDRA, il-Livell tatTerminu Ppreferut (PT - Preferred Term) u l-frekwenza Il-frekwenzi kienu evalwati skont il-konvenzjonijiet li ġejjin:
English: Routine laboratory tests may commonly reveal changes to liver functions (hyperbilirubinaemia) as well as changes in blood count (e.g. Coombs' (direct) test positive), increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate dehydrogenase).
Maltese: (iperbilirubinimja) kif ukoll bidliet fl-għadd tad-demm (eż. riżultat pożittiv għat-test (dirett) ta' Coombs), żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, żieda fil-lactate dehydrogenase fid-demm.
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' funzjoni ħażina tal-kliewi u insuffiċjenza akuta tal-kliewi kienu assoċjati mal-użu ta' ħafna millprodotti IVIg lliċenzjati li kien fihom diversi eċċipjenti bħal sucrose, glucose u maltose, dawk li kien fihom is-sucrose bħala stabbilizzatur kienu fi proporzjon kbir wisq meta mqabbla mat-total.
English: If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 4.8 ml/kg bw/hr.
Maltese: Jekk tkun ittollerata tajjeb (ara sezzjoni 4.4), ir-rata tista' tiżdied gradwalment sa massimu ta' 4.8 ml/kg piż tal-ġisem/siegħa.
English: • You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Maltese: • Inti tista' tkun allerġiku (tbati minn sensittività eċċessiva) għal immunoglobulini mingħajr ma tkun taf.
English: Of these, 72 completed the 12 months of treatment.
Maltese: Minn dawn, 72 temmew it-12-il xahar ta` trattament.
English: Patients with multifocal motor neuropathy (MMN).
Maltese: Pazjenti b'newropatija multifokali motorja (MMN - multifocal motor neuropathy).
English: Patients with Kawasaki disease.
Maltese: Pazjenti bil-marda ta' Kawasaki.
English: Experimental studies of the excipient L-proline carried out in animals found no direct or indirect toxicity affecting pregnancy, embryonal or foetal development.
Maltese: Studji sperimentali ta' l-eċċipjent L-proline mwettqa f'annimali ma sabu l-ebda tossiċità diretta jew indiretta li taffettwa tqala, l-iżvilupp embrijoniku jew tal-fetu.
English: 200 or 400 ml of solution in a single vial (type II glass), with a stopper (elastomeric), a cap (aluminium crimp), a flip off disc (plastic), label with integrated hanger.
Maltese: 200 jew 400 ml ta' soluzzjoni f'kunjett wieħed (ħġieġ ta' tip II), b'tapp (elastomeric), għatu (crimp ta'
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, il-kura medika standard għal xokk għandha tkun implimentata.
English: The results of this study show the median half-life of Privigen to be 31.1 days (see table below).
Maltese: F'dan l-istudju, il-half-life medjan ta' Privigen kien ta' 31.1 jiem (ara t-tabella hawn taħt).
English: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Maltese: Fertilità Mill-esperjenza klinika bl-immunoglobulini wieħed ma jistenna l-ebda effetti ħżiena fuq il-fertilità.
English: 2 g/kg bw in one dose in association with acetylsalicylic acid
Maltese: Il-pazjenti għandhom jirċievu l-kura fl-istess ħin b'acetylsalicylic acid.
English: Patients with an acquired immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4 g/l.
Maltese: Pazjenti b'immunodefiċjenza akkwiżita (SID - secondary immunodeficiency) li jsofru minn infezzjonijiet severi jew rikorrenti, trattament mhux effettiv kontra l-mikrobi u falliment ippruvat ta' antikorp speċifiku jew livell fis-serum ta' <4 g/l.
English: If insufficient treatment effect is seen after 6 months, the treatment should be discontinued.
Maltese: Jekk jidher effett insuffiċjenti tat-trattament wara 6 xhur, it-trattament għandu jitwaqqaf.
English: The mean improvement at the end of the treatment period compared to reference visit was 1.4 points in the PRIMA (1.8 points in IVIg pretreated subjects) and 1.2 points in PATH study.
Maltese: Il-medja tat-titjib fi tmiem il-perjodu ta' trattament mqabbla mal-vista ta' riferenza kienet 1.4 punti flistudju PRIMA (1.8 punti fl-individwi ttrattati minn qabel b'IVIg) u 1.2 punti fl-istudju PATH.
English: If dilution is desired, 5% glucose solution is recommended.
Maltese: Jekk id-dilwizzjoni tkun mixtieqa, għandha tintuża soluzzjoni ta' 5 % glucose.
English: 0.4 g/kg bw/d for 2 to 5 days
Maltese: 0.4 g/kg piż tal-ġisem/kuljum għal 2 sa 5 ijiem
English: How to store Privigen
Maltese: X'fih Privigen
English: In the second ITP study, 57 patients with ITP (baseline platelet counts ≤ 30×109 / l) aged between 18
Maltese: Fit-tieni studju ta' ITP, 57 pazjent b'ITP (għadd tal-plejtlits fil-linja bażi ≤ 30×109 / l) b'etajiet bejn 18 u 65 sena ġew ittrattati bi Privigen b'1 g/kg piż tal-ġisem.
English: Secondary immunodeficiencies (as defined in 4.1)
Maltese: Immunodefiċjenzi skondarji (kif definit f'4.1)
English: Headache (including sinus headache, migraine, head discomfort, tension headache), upset stomach (na usea), pain (including back pain, pain in extremity, joints and bones (arthralgia), neck pain, facial pain ), fever (including chills), flu-like illness (including runny nose (nasopharyngitis), sore throat (pharyng olaryngeal pain), blisters in mouth and throat (oropharyngeal blistering), throat tightness.
Maltese: Uġigħ ta' ras, (inkluż uġigħ ta' ras tas-sinus, emigranja, skumdità fir-ras, uġigħ ta' ras tat-tensjoni), sto nku mqalleb (nawsja), uġigħ (inkluż uġigħ fid-dahar, uġigħ fid-dirgħajn jew fir-riġlejn, fil-ġogi u fl-għ adam (artralġja), uġigħ fl-għonq, uġigħ filwiċċ, deni (inkluż tkexkix ta' bard), mard jixbah l-influwenza (inkluż imnieħer inixxi (nażofarinġite), griżmejn juġgħu (uġigħ fil-farinġi u l-larinġi), infafet fil-ħalq u fil-gerżuma (infafet fil-ħalq u fil-larinġ i), tagħfis fil-gerżuma.
English: starting dose: 2 g/kg bw in divided doses over 2 to 5 days maintenance dose: 1 g/kg bw every 3 weeks over 1 to 2 days
Maltese: 2 g/kg piż tal-ġisem fuq 2 sa 5 ijiem konsekuttivi doża ta' manteniment: 1 g/kg piż tal-ġisem kull 2 sa 4 ġimgħat jew
English: The dose required to achieve a trough level of 5 to 6 g/l is of the order of 0.2 to 0.8 g/kg bw/month.
Maltese: Id-doża meħtieġa biex jintlaħaq livell minimu ta' 5 sa 6 g/l hu ta' 0.2 sa 0.8 g/kg piż tal-ġisem/xahar.
English: 2 g/kg bw every 4 to 8 weeks over 2 to 5 days
Maltese: 2 g/kg piż tal-ġisem jew kull 4 sa 8 ġimgħat fuq 2 sa 5 ijiem
English: 0.4 g/kg bw/d for 5 days
Maltese: 0.4 g/kg piż tal-ġisem/kuljum għal 5 ijiem
English: 20 g/200 ml
Maltese: EU/1/08/446/003 20 g/200 ml
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially infusing the product slowly (0.3 ml/kg bw/hr); - are carefully monitored for any symptoms throughout the infusion period.
Maltese: Kumplikazzjonijiet potenzjali jistgħu ta' spiss jiġu evitati billi tiżgura li l-pazjenti: - ma jkunux sensittivi għal immunoglobulina normali umana billi inizjalment tagħti infużjoni bil mod tal-prodott (0.3 ml/kg piż tal-ġisem/siegħa), - ikunu mmonitorjati bl-attenzjoni għal kwalunkwe sintomi matul il-perijodu ta' l-infużjoni.
English: • The other ingredients (excipients) are the amino acid proline and water for injections.
Maltese: • Is-sustanzi l-oħra huma (eċċipjenti) l-amino acid proline u ilma għall-injezzjonijiet.
English: In replacement therapy the dose may need to be individualised for each patient depending on the pharmacokinetic and clinical response.
Maltese: Fit-terapija tas-sostituzzjoni, jista' jkun hemm bżonn li d-doża tkun individwalizzata għal kull pazjent skond ir-rispons farmakokinetiku u kliniku.