FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: B'mod rari, l-immunoglobulina normali umana tista' tikkaġuna tnaqqis fil-pressjoni tad-demm b'reazzjoni anafilattika, anki f'pazjenti li qabel kienu ttolleraw trattament b'immunoglobulina normali umana.
English: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome in replacement therapy indications.
Maltese: Il-pożoloġija fi tfal u adolexxenti (0-18-il sena) mhix differenti minn dik ta' l-adulti peress li l-pożoloġija għal kull indikazzjoni tingħata skont il-piż tal-ġisem u tiġi aġġustata skont ir-riżultat kliniku f'indikazzjonijiet ta' terapija ta' sostituzzjoni.
English: Administer solution which is at room or body temperature.
Maltese: Agħti soluzzjoni li jkollha temperatura tal-kamra jew temperatura tal-ġisem.
English: Adverse Reactions (ARs) have been collected in Hizentra clinical trials from 7 phase III studies in patients with primary immunodeficiency (n = 231), 2 phase IV studies in patients with PID (n=74), 1
Maltese: III f'pazjenti b'immunodefiċjenza primarja (n = 231), 2 studji ta' fażi
English: Treatmentof low immunoglobulin levels and recurrent bacterial infections in patients with chronic lymphocytic leukaemia(CLL), a certain kind of blood cancer, where prophylactic antibiotics have failed or are contra-indicated.
Maltese: Trattament ta' livelli baxxi ta' immunoglobulina u infezzjonijiet batteriċi rikorrenti f'pazjenti b'lewkimja limfoċitika kronika (chronic lymphocytic leukaemia - CLL), ċertu tip ta' kanċer taddemm, fejn antibijotiċi profilattiċi jkunu fallew jew huma kontraindikati.
English: If well-tolerated (see also section 4.4), the infusion rate can be increased up to 2.0 ml/min/site (120 ml/hour/site).
Maltese: Jekk tkun ittollerata tajjeb (ara wkoll sezzjoni 4.4), ir-rata ta' infużjoni tista' tiżdied sa 2.0 mL/min/sit (120 mL/siegħa/sit).
English: • combination of low level or absence of immunoglobulins and absence or non-functional immune cells (severe combined immunodeficiency)
Maltese: • kombinazzjoni ta' livell baxx jew nuqqas ta' immunoglobulini u nuqqas ta' ċelluli immuni jew ċelluli immuni mhux funzjonali (immunodefiċjenza kkombinata severa)
English: The safety and effectiveness of Hizentra have been established in paediatric subjects 2 to 18 years of age.
Maltese: Is-sigurtà u l-effikaċja ta' Hizentra ġew stabbiliti f'individwi pedjatriċi ta' età minn 2 sa 18-il sena.
English: Manual push infusion:
Maltese: Infużjoni permezz ta' apparat:
English: Dizziness, Migraine
Maltese: Dijarea, Uġigħ addominali
English: Muscle spasm, Muscular weakness
Maltese: Spażmi fil-muskoli, Dgħufija fil-muskoli
English: After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals to reach a cumulative monthly dose of the order of 0.4 to 0.8 g/kg (2.0 to 4.0 ml/kg) body weight.
Maltese: Wara li livelli ta' stadju fiss ta' IgG ikunu ġew milħuqa, dożi ta' manteniment għandhom jingħataw f'intervalli ripetuti sabiex tintlaħaq doża kumulattiva kull xahar li tinsab fil-firxa ta' bejn 0.4 sa 0.8 g/kg tal-piż tal-ġisem (2.0 sa 4.0 ml/kg).
English: Down-titrating patients in the extension study who completed the PATH study on either dose from 0.4 g/kg to 0.2 g/kg bw dose was possible in 67.9 % of subjects (19/28 patients) without occurrence of relapse; all of the 9 relapsers recovered within 4 weeks after treatment with 0.4 g/kg bw dose.
Maltese: Tnaqqis fid-doża fl-istudju ta' estensjoni f'pazjenti li temmew l-istudju PATH fuq xi waħda mid-dożi minn dożi ta' 0.4 g/kg sa 0.2 g/kg bw kien possibbli f'67.9 % tal-individwi (19/28 pazjent) mingħajr l-okkorrenza ta' rikaduta; kull wieħed mid-9 li rkadew irkupraw fi żmien 4 ġimgħat wara trattament b'doża ta' 0.4 g/kg bw.
English: Dosage
Maltese: Kunjetti
English: Information on safety with respect to transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Informazzjoni dwar is-sigurtà fir-rigward ta' elementi naturali li jistgħu jkunu trasmessi Miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l-għażla tad-donaturi, screening ta' donazzjonijiet individwali u ta' pools tal-plażma għal markaturi speċifiċi ta' infezzjoni u l-inklużjoni ta' miżuri effettivi filproċess tal-manifattura għall-inattivazzjoni/tneħħija ta' viruses.
English: Vascular disorders Hypertension
Maltese: Disturbi vaskulari Ipertensjoni
English: 172 adults with definite or probable CIDP who were previously treated with and responded to IVIg were randomised to weekly 0.2 g/kg bw Hizentra, weekly 0.4 g/kg bw Hizentra or placebo groups, and followed for a subsequent 24 weeks.
Maltese: Polyneuropathy and Treatment with Hizentra]. 172 adult b'CIDP ċerta jew probabbli li qabel kienu ġew ittrattati bi u rrispondew għal IVIg intagħżlu b'mod arbitrarju għal Hizentra 0.2 g/kg piż tal-ġisem darba fil-ġimgħa, Hizentra 0.4 g/kg piż tal-ġisem darba fil-ġimgħa jew gruppi tal-plaċebo, u ġew segwiti għall-24 ġimgħa sussegwenti.
English: Simulations with population-pharmacokinetic models in the PATH study suggest that a comparable IgG exposure (Cmax, AUC0-14days, Cmin, 14 days) is achieved when the double weekly Hizentra dose is administered every two weeks in the CIDP subjects.
Maltese: Simulazzjonijiet b'mudelli farmakokinetiċi ta' popolazzjoni fl-istudju PATH jissuġġerixxu li esponiment kumparabbli għall-IgG (Cmax, AUC0-14 il jum, Cmin, 14-il jum) jinkiseb meta d-doża doppja ta' Hizentra darba fil-ġimgħa tingħata kull ġimagħtejn fl-individwi b'CIDP.
English: Do NOT infuse Hizentra ► if you are allergic to human immunoglobulins, polysorbate 80 or L-proline.
Maltese: TAGĦTIX infużjoni ta' Hizentra ► jekk inti allerġiku għal immunoglobulini umani jew għal polysorbate 80 jew L-proline.
English: 1. manual push flow rates
Maltese: 1. rati ta' fluss ta' imbuttar manwali
English: Hizentra must not be given intravascularly.
Maltese: Hizentra huwa essenzjalment mingħajr sodju.
English: Treatment of patients who are born with a reduced ability or inability to produce immunoglobulins (primary immunodeficiencies).
Maltese: Trattament ta' pazjenti li jitwieldu b'nuqqas ta' ħila li jipproduċu immunoglobulini jew li ma jkunux kapaċi jipproduċu immunoglobulini (immunodefiċjenzi primarji).
English: ► In isolated cases, you may get a bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light, which could be signs of AMS (aseptic meningitis sydrome), which is a temporary reversible non-infectious inflammation of the membranes surrounding the brain and the spinal cord.
Maltese: ► F'każijiet iżolati, jista' jaqbdek uġigħ ta' ras qawwi b'dardir, rimettar, ebusija fl-għonq, deni, u sensittività għad-dawl, li jistgħu jkunu sinjali ta' AMS (sindrome ta' meninġite asettika, aseptic meningitis sydrome), li hija infjammazzjoni mhux infettiva, temporanja u riversibbli tal membrani madwar il-moħħ u s-sinsla tad-dahar.
English: Hizentra has not been evaluated in clinical studies in paediatric patients with CIDP who are under the age of 18.
Maltese: Hizentra ma ġiex ivvalutat fi studji kliniċi f'pazjenti pedjatriċi b'CIDP li għandhom anqas minn 18-il sena.
English: Subjects received in total 1,831 weekly Hizentra infusions.
Maltese: L-individwi rċevew b'kollox 1,831 infużjoni ta' Hizentra kull ġimgħa.
English: A loading dose of at least 0.2 to 0.5 g/kg (1.0 to 2.5 ml/kg) body weight may be required.
Maltese: Doża inizjali ta' mill-inqas 0.2 sa 0.5 g/kg (1.0 sa 2.5 ml/kg) tal-piż tal-ġisem għandha mnejn tkun meħtieġa.
English: The difference observed between the 0.2 g/kg bw and the 0.4 g/kg bw Hizentra groups did not reach statistical significance.
Maltese: Id-differenza osservata bejn il-gruppi ta' Hizentra 0.2 g/kg piż tal-ġisem u 0.4 g/kg piż tal-ġisem ma laħqitx sinifikat statistiku.
English: There were no differences in the pharmacokinetics, safety and efficacy profiles as compared with adult subjects.
Maltese: Ma kienx hemm differenzi fil-profili farmakokinetiċi, tassigurtà u l-effikaċja meta mqabbla ma' individwi adulti.
English: Hizentra was evaluated in 68 paediatric subjects with PID aged 2 to <12 years and in 57 adolescents aged 12 to <18 years.
Maltese: Hizentra ġie evalwat f'68 individwu pedjatriku b'PID b'età minn sentejn sa <12-il sena u f'57 adolexxent b'età minn 12 sa <18-il sena.
English: • low immunoglobulin levels (hypogammaglobulinaemia) or absence of immunoglobulins (agammaglobulinaemia) in the blood
Maltese: • livelli baxxi ta' immunoglobulini (ipogammaglobulinemija) jew nuqqas ta' immunoglobulini (agammaglobulinemija) fid-demm
English: Accordingly, over the treatment period for up to 24 weeks Hizentra prevented relapse in 81 % and 67 % of subjects in the 0.4 g/kg bw and 0.2 g/kg bw group, respectively, while in the placebo group 44 % of subjects remained relapse-free.
Maltese: Konsegwentement, matul il-perjodu ta' trattament sa 24 ġimgħa Hizentra evita r-rikaduta f'81 % u 67 % tal-individwi fil-grupp ta' 0.4 g/kg piż tal-ġisem u 0.2 g/kg piż talġisem, rispettivament, filwaqt li fil-grupp tal-plaċebo 44 % tal-indivdiwi baqgħu mingħajr rikaduta.
English: In the PATH study, subjects (n = 172) achieved sustained trough levels over a period of 24 weeks when receiving weekly doses of 0.2 g/kg bw and 0.4 g/kg bw, respectively.
Maltese: Fl-istudju PATH, l-individwi (n = 172) kisbu livelli l-aktar baxxi li nżammu fuq perjodu ta' 24 ġimgħa meta rċivew dożi darba f'ġimgħa ta' 0.2 g/kg piż tal-ġisem u 0.4 g/kg piż tal-ġisem, rispettivament.
English: Hizentra 200 mg/ml solution for subcutaneous injection Human normal immunoglobulin (SCIg = Subcutaneous Immunoglobulin)
Maltese: Immunoglobulina normali umana (SCIg = Subcutaneous Immunoglobulin)
English: Subjects in the high dose Hizentra group remained stable in the Rasch-built Overall Disability Scale (R-ODS) centile score.
Maltese: L-individwi fil-grupp tad-doża l-għolja ta' Hizentra baqgħu stabbli fil-punteġġ sentajl fuq l-Iskala ta' Diżabilità Globali mibnija fuq il-mudell ta' Rasch (R-ODS, Rasch-built Overall Disability Scale).
English: • You may infuse Hizentra into sites such as abdomen, thigh, upper arm, and lateral hip.
Maltese: • Tista' tagħti infużjoni ta' Hizentra f'siti bħaż-żaqq, il-koxxa, in-naħa ta' fuq tad-driegħ, u l-ġenb laterali.
English: Transfer Hizentra to syringe for infusion - Attach a transfer device or needle to a sterile syringe, using aseptic technique.
Maltese: Ittrasferixxi Hizentra ġos-siringa tal-infużjoni - Waħħal apparat ta' trasferiment jew labra ma' siringa sterili, billi tuża teknika asettika.
English: • Muscle spasm
Maltese: • Uġigħ fis-sider
English: For all patients who received 0.2 g/kg bw in the extension study, 47.9 % (35/73 patients) had a relapse.
Maltese: Għall-pazjenti kollha li rċivew 0.2 g/kg bw fl-istudju ta' estensjoni, 47.9% (35/73 pazjent) kellhom rikaduta.
English: The recommended infusion rate given under section 4.2 should be adhered to.
Maltese: Ir-rata ta' infużjoni rakkomandata taħt sezzjoni 4.2 għandha tiġi segwita.
English: PRE-FILLED SYRINGE
Maltese: Rata tal-infużjoni
English: This medicine contains trace amounts of IgA (not more than 50 micrograms /ml).
Maltese: Din il-mediċina fiha traċċi ta' IgA (mhux aktar minn 50 mikrogramma/ml)
English: In the efficacy scores (INCAT score, mean grip strength, and Medical Research Council sum score), subjects in both Hizentra dose groups remained stable while subjects in the placebo group deteriorated.
Maltese: Fil-punteġġi tal-effikaċja (punteġġ INCAT, qawwa medja tal-qabda, u punteġġ tat-total tal-Kunsill Mediku tar-Riċerka), l-individwi fiż-żewġ gruppi tad-dożi ta' Hizentra baqgħu stabbli filwaqt li lindividwi fil-grupp ta' plaċebo ddeterjoraw.
English: Solution for subcutaneous injection.
Maltese: virus/infezzjonijiet.
English: A statistically significant lower percentage of subjects treated with Hizentra, 32.8 % for 0.4 g/kg bw and 38.6 % for 0.2 g/kg bw, had CIDP relapse or was withdrawn for other reasons compared with 63.2 % subjects treated with placebo (p < 0.001 or p = 0.007, respectively).
Maltese: Perċentwal aktar baxx sinifikanti b'mod statistiku ta' individwi ttrattati b'Hizentra, 32.8 % għal 0.4 g/kg piż tal-ġisem u 38.6 % għal 0.2 g/kg piż tal-ġisem, kellhom rikaduta ta' CIDP jew twaqqfu għal raġunijiet oħra meta mqabbla ma' 63.2 % tal-individwi ttrattati bi plaċebo (p < 0.001 jew p = 0.007, rispettivament).
English: The primary efficacy endpoint was the percentage of subjects who had a CIDP relapse (defined as a ≥ 1 point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] score compared with baseline) or were withdrawn for any other reason in the Hizentra treatment period.
Maltese: Infjammatorja [INCAT, Inflammatory Neuropathy Cause and Treatment] mqabbel mal-linja bażi) jew li twaqqfu għal kwalunkwe raġuni fil-perjodu ta' trattament b'Hizentra.
English: In a third group, infusion volumes of 25, 40 and 50ml per site were additionally evaluated in pump-assisted administration of weekly Hizentra doses (n=15).
Maltese: Fit-tielet grupp, il-volumi ta' infużjoni ta' 25, 40 u 50 mL għal kull sit ġew evalwati wkoll b'għoti bil-pompa tad-dożi ta' kull ġimgħa ta' Hizentra (n=15).
English: If using a transfer device (vented spike), follow the instructions provided by the device manufacturer.
Maltese: Jekk tuża apparat ta' trasferiment (apparat ippuntat imtaqqab minn ġewwa), segwi l-istruzzjonijiet ipprovduti millmanifattur tal-apparat.
English: Pack sizes Packs of 1, 10 or 20 vials
Maltese: Daqsijiet tal-pakkett Daqsijiet ta' 1, 10 jew 20 kunjett
English: The ADRs reported in these clinical studies are summarised and categorised according to the MedDRA System Organ Class (SOC and Preferred Term level) and frequency below.
Maltese: L-ADRs irrapportati f'dawn l-istudji kliniċi huma miġbura fil-qosor u kategorizzati skont il-Klassi tas-Sistemi u tal-Organi MedDRA (SOC, System Organ Class u Livell tat-Terminu Ppreferut) u l-frekwenza hawn taħt.
English: No overall differences in the pharmacokinetic parameters were observed between PID subjects >65 years and subjects 18 to 65 years of age.
Maltese: Ma dehru l-ebda differenzi globali fil-parametri farmakokinetiċi bejn individwi b'PID b'età ta' >65 sena u individwi b'età ta' 18 sa 65 sena.
English: Hizentra may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox.
Maltese: Hizentra jista' jdgħajjef l-effett ta' xi tilqim ta' virus ħajjin bħal ħosba, rubella, gattone, u ġidri r-riħ.
English: Simulations by empirical Population Pharmacokinetic models suggested that comparable IgG exposure levels (AUC0-14days, Cmin 14days) may be obtained if Hizentra is administered subcutaneously every two weeks using double the weekly dose during maintenance therapy.
Maltese: Simulazzjonijiet b'mudelli empiriċi tal-Farmakokinetika tal-Popolazzjoni kienu jissuġġerixxu li livelli komparabbli ta' esponiment għal IgG (AUC0-14-il jum, Cmin 14-il jum) jistgħu jinkisbu jekk Hizentra jingħata taħt il-ġilda kull ġimagħtejn b'doża id-doppju tad-doża ta' kull ġimgħa waqt terapija ta' manteniment.
English: United Kingdom CSL Behring UK Ltd. Tel: +44 (0)1444 447405
Maltese: Tel: +44 (0)1444 447405
English: • Fast heartbeat (tachycardia)
Maltese: • Qalb tħabbat tgħaġġel (takikardija)
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Maltese: Għandha distribuzzjoni ta' sottoklassijiet ta' immunoglobulina G li tixbah proporzjonalment mill-qrib lil dik li tinsab normalment fil-plażma umana nattiva.
English: Caution should be exercised 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 immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity).
Maltese: Għandu jkun hemm attenzjoni f'pazjenti b'fatturi ta' riskju eżistenti minn qabel għal avvenimenti trombotiċi (bħal età avanzata, pressjoni għolja, dijabete mellitus u storja medika ta' mard vaskulari jew episodji trombotiċi, pazjenti li għandhom disturbi trombofiliċi miksuba jew li ntirtu, pazjenti b'perjodi twal ta' immobilizzazzjoni, pazjenti ipovolemiċi b'mod sever, pazjenti b'mard li jżid il-viskożità tad-demm).
English: Treatment of low immunoglobulin levels and recurrent bacterial infections in patients with multiple myeloma (MM), another kind of blood cancer.
Maltese: Trattament ta' livelli baxxi ta' immunoglobulina u infezzjonijiet batteriċi rikorrenti f'pazjenti b'majeloma multipla (MM), tip ieħor ta' kanċer tad-demm.
English: CSL Behring Sp. z o.o.
Maltese: CSL Behring S.p.A.
English: Infusion site ulcer
Maltese: Ulċera fil-post tal-infużjoni
English: • Flushing
Maltese: • Sturdament
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be switched to Hizentra only under close medical supervision.
Maltese: Pazjenti li għandhom antikorpi anti-IgA, li għalihom it-trattament bi prodotti IgG mogħtija taħt il-ġilda jibqa' l-unika għażla, għandhom jinqalbu għal fuq Hizentra biss taħt superviżjoni medika mill-qrib.
English: Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Maltese: Reazzjonijiet lokali fis-siti tal-infużjoni: nefħa, selħa, uġigħ, ħmura, ebusija, sħana lokali, ħakk, tbenġil u raxx.
English: The recommended initial infusion rate is up to 20 ml/hour/site.
Maltese: Ir-rata inizjali tal-infużjoni rakkomandata hi sa 20 ml/siegħa/sit.
English: In case of clinical deterioration the dose may be increased to the recommended maximum of 0.4g/kg weekly dose.
Maltese: F'każ ta' deterjorament kliniku d-doża tista' tiżdied għad-doża massima rrakkomandata ta' 0.4g/kg fil-ġimgħa.
English: 2. pump-assisted flow rates
Maltese: 2. rati ta' fluss bil-pompa
English: Hizentra is available in pre-filled syringes of 5 or 10 ml.
Maltese: Hizentra jiġi wkoll f'siringi mimlija għal-lest ta' 5 u 10 ml.
English: • Abdominal pain
Maltese: • Sintomi bħal tal-influwenza
English: The recommended infusionrate given under section 3“How to use Hizentra” must be closely followed.
Maltese: Ir-rata rakkomandata ta' infużjoni li qed tingħata f'sezzjoni 3, “Kif għandek Tuża Hezentra” għandha tiġi segwita mill-qrib.
English: Each pre-filled syringe of 5 ml solution contains: 1 g human normal immunoglobulin Each pre-filled syringe of 10 ml solution contains: 2 g human normal immunoglobulin
Maltese: Kull kunjett ta' 5 ml soluzzjoni fih: 1 g ta' immunoglobulina normali umana
English: The mean dose administered each week was 0.12 g/kg body weight (bw).
Maltese: (3.06) g/l fil-grupp ta' 0.2 g/kg piż tal-ġisem.
English: The safety, efficacy and tolerability of Hizentra in patients with CIDP has been assessed in a multicentre, double-blind, randomised, placebo-controlled, parallel-group phase III PATH [Polyneuropathy and Treatment with Hizentra] study.
Maltese: III b'ħafna ċentri, arbitrarju, ikkontrollat bi plaċebo, bi grupp parallel, fejn la l-investigaturi u lanqas lindividwi ma kienu jafu liema sustanza qed tintuża, PATH [Polinewropatija u Trattament b'Hizentra,
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: (infjammazzjoni tal-fwied) u għall-viruses mhux inveloppati tal-virus tal-epatite A u l-parvovirus B19.
English: In a clinical phase III trial with Hizentra (n = 46), the subjects achieved sustained trough levels (median 8.1 g/l) over a period of 29 weeks when receiving median weekly doses of 0.06 to 0.24 g/kgbw.
Maltese: III b'Hizentra (n = 46), l-individwi kisbu livelli sostnuti l-aktar baxxi (medjan 8.1 g/l) fuq perijodu ta' 29 ġimgħa meta kienu qed jirċievu dożi kull ġimgħa ta' 0.06 sa 0.24 g/kg talpiż tal-ġisem.
English: If large doses are given (> 50 ml), try to administer them at multiple sites.
Maltese: Jekk jingħataw dożi kbar (> 50 ml), ipprova amministrahom f'aktar minn sit wieħed.
English: Each vial of 5 ml solution contains: 1 g of human normal immunoglobulin Each vial of 10 ml solution contains: 2 g of human normal immunoglobulin Each vial of 20 ml solution contains: 4 g of human normal immunoglobulin Each vial of 50 ml solution contains: 10 g of human normal immunoglobulin
Maltese: Kumplikazzjonijiet potenzjali jistgħu ta' spiss jiġu evitati billi tiżgura li l-pazjenti: - ma jkunux sensittivi għal immunoglobulina normali umana billi inizjalment tagħti infużjoni talprodott bil-mod (ara sezzjoni 4.2); - ikunu mmonitorjati bl-attenzjoni għal kull sintomu matul il-perijodu tal-infużjoni.
English: Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Maltese: Reazzjonijiet avversi bħal tertir, uġigħ ta' ras, deni, rimettar, reazzjonijiet allerġiċi, dardir, artralġja, pressjoni tad-demm baxxa u uġigħ moderat fin-naħa t'isfel tad-dahar, jistgħu jseħħu kultant.
English: The following side effects are common (affects 1 to 10 patients in 100):
Maltese: L-effetti sekondarji li ġejjin huma komuni (jaffettwaw minn pazjent 1 sa 10 pazjenti minn kull 100):
English: ► In isolated cases, you may experience pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body, sudden confusion, or trouble speaking or understanding could be signs of a blood clot.
Maltese: ► F'każijiet iżolati, jista' jkollok uġigħ u/jew nefħa ta' driegħ jew riġel bi sħana fiż-żona affettwata, bidla fil-kulur ta' driegħ jew riġel, qtugħ ta' nifs mingħajr spjegazzjoni, uġigħ jew skumdità fis-sider li jiggravaw ma' nifs fil-fond, polz mgħaġġel mingħajr spjegazzjoni, titrix jew dgħufija fuq naħa waħda tal-ġisem, konfużjoni f'daqqa, jew problemi biex tkellem jew tifhem jistgħu jkunu sinjali ta' tagħqid tad-demm.
English: In case of home treatment, this will be initiated by a healthcare professional experienced in the treatment of immunodeficiency/CIDP with SCIg and in the guidance of patients for home treatment.
Maltese: F'każ ta' trattament id-dar, dan ser jinbeda minn professjonist fil-qasam tal-kura tas-saħħa b'esperjenza fit-trattament ta' immunodefiċjenza/CIDP b'SCIg u fit-tmexxija ta' pazjenti għal trattament fid-dar.
English: After infusion of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Maltese: Wara infużjoni tal-immunoglobulin iż-żieda għaddiena tad-diversi antikorpi trasferiti b'mod passiv fid-demm tal-pazjent tista' tirriżulta f'riżultati pożittivi qarrieqa f'testijiet seroloġiċi.
English: The primary endpoint was the percentage of subjects responding to a higher infusion parameter:
Maltese: L-iskop finali primarju kien il-perċentwali ta' individwi li rrispondew għal parametru ta' infużjoni ogħla:
English: The therapy with Hizentra is initiated 1 week after the last IVIg infusion.
Maltese: It-terapija b'Hizentra tinbeda ġimgħa wara l-aħħar infużjoni ta' IVIg.
English: Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.
Maltese: Sindrome ta' Meninġite Asettika (AMS - Aseptic Meningitis Syndrome) AMS kienet irrappurtata bl-użu ta' IVIg jew SCIg.
English: Pack sizes of 1 or 10 pre-filled syringes: 1 g / 5 ml
Maltese: Daqsijiet tal-pakkett ta' siringa 1 jew 10 siringi mimlija għal-lest: 1 g / 5 ml