FrancophonIA/ELRC3.0 huggingface dataset:
English: CSL Behring GmbH D-35041 Marburg Germany
Maltese: CSL Behring GmbH D-35041 Marburg Il-Ġermanja
English: 5, 10 or 20 ml of solution in a vial (type I glass) and 50 ml of solution in a vial (type II glass), with a stopper (halobutyl), a cap (aluminium crimp) and a flip off disc (plastic).
Maltese: 5, 10 jew 20 ml ta' soluzzjoni f'kunjett (ħġieġ ta' tip I) u 50 ml ta' soluzzjoni f'kunjett (ħġieġ ta' tip II), b'tapp (halobutyl), għatu (crimp tal-aluminju), u diska flip off (plastik).
English: Excipients: L-proline, polysorbate 80, water for injections.
Maltese: L-proline, polysorbate 80, ilma għal injezzjonijiet.
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell allo-antibodies (Coombs' test).
Maltese: It-trasmissjoni passiva ta' antikorpi għal antiġeni fl-eritroċiti, eż A, B, D tista' tfixkel xi testijiet seroloġiċi għal allo-antikorpi taċ-ċelluli ħomor (Test ta' Coombs).
English: Human normal immunoglobulin................................................................................................ 200 mg (purity: at least 98% is immunoglobulin type G (IgG))
Maltese: Immunoglobulina normali umana ................................................................................................. 200 mg
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 1,000 donatur.
English: Side effects observed in post-marketing are of unknown frequency:
Maltese: Effetti sekondarji osservati wara t-tqegħid fis-suq huma ta' frekwenza mhux magħrufa:
English: • aseptic infusion techniques
Maltese: • teknika ta' infużjoni asettika
English: Musculoskeletal pain, Arthralgia
Maltese: Uġigħ muskoluskeletriku, Artralġja
English: Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins.
Maltese: Avvenimenti tromboemboliċi fl-arterji u fil-vini inkluż infart mijokardijaku, puplesija, trombożi filvini tal-fond u emboliżmu pulmonari kienu assoċjati mal-użu ta' immunoglobulini.
English: phase III study (n = 115), and 1 extension study (n = 82) in patients with CIDP (total N = 502 patients; 26,646 infusions).
Maltese: IV f'pazjenti b'PID (n=74), studju wieħed ta' fażi III (n = 115), u studju wieħed ta' estensjoni (n = 82) f'pazjenti b'CIDP (total N = 502 pazjenti; 26,646 infużjoni).
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration, ATC code: J06BA01.
Maltese: Kategorija farmakoterapewtika: sera immuni u immunoglobulini: immunoglobulini, normali umani, biex jingħataw b'mod ekstravaskulari.
English: 5 Preparation of Hizentra for infusion
Maltese: 5 Preparazzjoni ta' Hizentra għall-infużjoni
English: Interference with serological testing
Maltese: Interferenza ma' testijiet seroloġiċi
English: Elimination IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Maltese: IgG u kumplessi ta' IgG jiġu ddiżintegrati fiċ-ċelluli tas-sistema retikuloendoteljali.
English: 30 ml/hour/site 60 ml/hour/site 120 ml/hour/site
Maltese: 30 mL/siegħa/sit 60 mL/siegħa/sit 120 mL/siegħa/sit
English: Time to CIDP relapse (Figure 1) was evaluated, and the corresponding probabilities for CIDP relapse based on Kaplan-Meier estimates were: placebo, 58.8 %; 0.2 /kg bw Hizentra, 35.0 %; and 0.4 g/kg bw Hizentra, 22.4 %.
Maltese: Ġie stmat iż-żmien għar-rikaduta ta' CIDP (Figura 1), u l-probabbiltajiet korrispondenti għar-rikaduta ta' CIDP abbażi tal-istimi Kaplan-Meier kienu: plaċebo, 58.8 %; Hizentra 0.2 /kg piż tal-ġisem, 35.0 %; u Hizentra 0.4 g/kg piż tal-ġisem, 22.4 %.
English: Hizentra is available in vials of 5, 10, 20 or 50 ml.
Maltese: Hizentra jiġi wkoll f'kunjetti ta' 5, 10, 20 u 50 ml.
English: CSL Behring SA Tél: + 33 1 53 58 54 00
Maltese: Tél: + 33 1 53 58 54 00
English: EU/1/11/687/001 1 x 5 ml vial EU/1/11/687/002 10 x 5 ml vials EU/1/11/687/003 20 x 5 ml vials EU/1/11/687/004 1 x 10 ml vial EU/1/11/687/005 10 x 10 ml vials EU/1/11/687/006 20 x 10 ml vials EU/1/11/687/010 1 x 20 ml vial EU/1/11/687/011 10 x 20 ml vials EU/1/11/687/012 20 x 20 ml vials EU/1/11/687/013 1 x 50 ml vial EU/1/11/687/014 10 x 50 ml vials
Maltese: EU/1/11/687/001 kunjett 1 x 5 ml EU/1/11/687/002 10 kunjetti x 5 ml EU/1/11/687/003 20 kunjett x 5 ml EU/1/11/687/004 kunjett 1 x 10 ml EU/1/11/687/005 10 kunjetti x 10 ml EU/1/11/687/006 20 kunjett x 10 ml EU/1/11/687/010 kunjett 1 x 20 ml EU/1/11/687/011 10 kunjetti x 20 ml EU/1/11/687/012 20 kunjett x 20 ml EU/1/11/687/013 kunjett 1 x 50 ml EU/1/11/687/014 10 kunjetti x 50 ml
English: Hizentra is essentially sodium free.
Maltese: Hizentra huwa essenzjalment mingħajr sodium.
English: 25 ml/hour/site 50 ml/hour/site 75 ml/hour/site 100 ml/hour/site
Maltese: 25 mL/siegħa/sit 50 mL/siegħa/sit 75 mL/siegħa/sit 100 mL/siegħa/sit
English: • an infusion device, or
Maltese: • apparat tal-infużjoni, jew
English: Replacement therapy
Maltese: Terapija ta' sostituzzjoni
English: Pre-filled syringes 5, or 10 ml of solution in a pre-filled syringe (cyclo-olefin-copolymer (COC)).
Maltese: Siringi mimlija għal-lest 5, jew 10 ml ta' soluzzjoni f'siringa mimlija għal-lest (cyclo-olefin-copolymer (COC)).
English: The mean duration of exposure was 118.9 days in the 0.2 g/kg bw and 129 days in the 0.4 g/kg bw Hizentra group (maximum exposure up to 167 and 166 days in each group, respectively).
Maltese: It-tul ta' żmien medju ta' esponiment kien 118.9 jum fil-grupp ta' Hizentra 0.2 g/kg piż tal-ġisem u 129 jum fil-grupp ta' 0.4 g/kg piż tal-ġisem (esponiment massimu sa 167 u 166 jum f'kull grupp, rispettivament).
English: • Itching (pruritus)
Maltese: • Ħakk (prurite)
English: The hazard ratios (95 % CI) for the lower dose and higher dose compared to placebo was 0.48 (0.27, 0.85) and 0.25 (0.12, 0.49), respectively.
Maltese: Il-proporzjonijiet ta' periklu (95 % CI) għad-doża l baxxa u għad-doża ogħla mqabbla mal-plaċebo kienu 0.48 (0.27, 0.85) u 0.25 (0.12, 0.49),
English: Clinical trials with Hizentra showed a similar overall safety profile in paediatric and adult patients with PID.
Maltese: Il-provi kliniċi b'Hizentra wrew profil tas-sigurtà globali simili f'pazjenti pedjatriċi u f'adulti b'PID.
English: EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003
Maltese: EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003 EU/1/11/687/004
English: For spontaneous post-marketing ADRs, the reporting frequency is categorised as unknown.
Maltese: Għal ADRs spontanji wara t-tqegħid fis-suq, ilfrekwenza tar-rappurtar hija kategorizzata bħala mhux magħrufa.
English: Vial(s)
Maltese: Kunjett(i)
English: 25 ml/site
Maltese: 25 mL/sit
English: Treatment of low immunoglobulin levels in patients pre- and post- allogeneic haematopoietic stem cell transplantation (HSCT).
Maltese: Trattament ta' livelli baxxi ta' immunoglobulina f'pazjenti bi trapjant ta' ċelluli steminali ematopojetiċi pre u post alloġeniċi (haematopoietic stem cell transplantation- HSCT).
English: • Involuntary shaking movements in one or more parts of the body (tremor, including psychomotor hyperactivity)
Maltese: • Movimenti ta' ċaqlieq involontarju f'parti waħda jew aktar tal-ġisem (rogħda, inkluża attività psikomotorja eċċessiva)
English: In total, 57 subjects received 1514 infusions in the placebo group, 57 subjects received 2007 infusions in the 0.2 g/kg bw Hizentra group, and 58 subjects received 2218 infusions in the 0.4 g/kg bw Hizentra group (in total 5739 infusions).
Maltese: B'kollox, 57 individwu rċivew 1,514-il infużjoni fil-grupp ta' plaċebo, 57 individwu rċivew 2,007 infużjonijiet fil-grupp ta' Hizentra 0.2 g/kg piż tal-ġisem, u 58 individwu rċivew 2,218-il infużjoni fil-grupp ta' Hizentra 0.4 g/kg piż tal-ġisem (5,739 infużjoni b'kollox).
English: 7 Prepare infusion site(s)
Maltese: 7 Ipprepara l-post(ijiet) tal-infużjoni
English: In adults doses may be given up to 50 ml/site.
Maltese: Fl-adulti jistgħu jingħataw dożi sa 50 mL/sit.
English: Immunomodulatory therapy in adults, children and adolescents (0-18 years):
Maltese: Il-mediċina tintuża f'adulti u tfal (0-18-il sena) fissitwazzjonijiet li ġejjin:
English: • you have switched from a different medicine
Maltese: • qlibt minn mediċina differenti
English: True allergic reactions are rare.
Maltese: Madankollu, reazzjonijiet allerġiċi reali huma rari.
English: Overall, the number of infusions without severe local reactions versus the total number of infusions (tolerability) was ≥ 0.98 in all groups for all infusion parameters.
Maltese: Globalment, l-għadd ta' infużjonijiet mingħajr reazzjonijiet lokali severi kontra in-numru totali tal infużjonijiet (tollerabilità) kien ≥ 0.98 f'kull grupp għall-parametri kollha ta' infużjoni.
English: Patients with hyperprolinaemia type I or II.
Maltese: Pazjenti b'iperprolinemija tip I jew II.
English: • Chills, including low body temperature
Maltese: • Tkexkix ta' bard, inkluża temperatura baxxa tal-ġisem
English: One ml contains 200 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin type G (IgG).
Maltese: Millilitru wieħed fih 200 mg ta' immunoglobulin normali umana li minn din tal-anqas 98% hija immunoglobulina tip G (IgG).
English: EU/1/11/687/015 1 x 5 ml pre-filled syringe EU/1/11/687/016 10 x 5 ml pre-filled syringes EU/1/11/687/017 1 x 10 ml pre-filled syringe EU/1/11/687/018 10 x 10 ml pre-filled syringes
Maltese: EU/1/11/687/015 1 x 5 ml siringa mimlija għal-lest EU/1/11/687/016 10 x 5 ml siringa mimlija għal-lest EU/1/11/687/017 1 x 10 ml siringa mimlija għal-lest EU/1/11/687/018 10 x 10 ml siringa mimlija għal-lest
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (liver inflammation), and for the non-enveloped hepatitis A virus and parvovirus B19.
Maltese: Il-miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses inveloppati bħall-virus tal-immunodefiċjenza umana (HIV, il-virus tal-AIDS), il-virus tal-epatite B u l-virus tal-epatite Ċ (infjammazzjoni tal-fwied) u għall-viruses mhux inveloppati tal-virus tal-epatite A u l-parvovirus B19.
English: Information available from clinical trials showed no difference in the safety profile of patients ≥ 65 years of age than of younger patients.
Maltese: Informazzjoni disponibbli minn provi kliniċi ma wriet l-ebda differenza fil-profil ta' sigurtà ta' pazjenti b'età ta' ≥ 65 sena u dak ta' pazjenti iżgħar.
English: Pre-filled syringe(s)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: The recommended initial infusion rate is up to 0.5 ml/min/site (30 ml/hour/site).
Maltese: Ir-rata inizjali tal-infużjoni rakkomandata hi sa 0.5 mL/min/sit (30 mL/siegħa/sit).
English: 40 ml/site
Maltese: 40 mL/sit
English: Marketing Authorisation Holder and Manufacturer CSL Behring GmbH
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur CSL Behring GmbH
English: In the first patient group receiving Hizentra via the manual push technique (n=16), 2 to 7 infusions per week were administered with the flow rates of 30, 60 and 120 ml/hour/site (see section 4.2).
Maltese: Fl-ewwel grupp ta' pazjenti li ngħataw Hizentra permezz tat-teknika ta' mbuttar manwali (n=16), ingħataw 2 sa 7 infużjonijiet kull ġimgħa bir-rati ta' fluss ta' 30, 60 u 120 mL/siegħa/sit (ara sezzjoni 4.2).
English: • The other ingredients (excipients) are L-proline, polysorbate 80 and water for injections.
Maltese: • Is-sustanza(i) l-oħra (eċċipjenti) huma L-proline, polysorbate 80 u ilma għall-injezzjonijiet.
English: IgG2 ............. 26%
Maltese: IgG1 .............. 69% IgG2 .............. 26% IgG3 .............. 3% IgG4 .............. 2%
English: • combination of low immunoglobulin levels, frequent infections and inability to produce adequate amounts of antibodiesafter vaccination (common variable immunodeficiency)
Maltese: • kombinazzjoni ta' livelli baxxi ta' immunoglobulini, infezzjonijiet ta' spiss u inkapaċità li tipproduċi ammonti adegwati ta' antikorpi wara tilqim (immunodefiċjenza varjabbli komuni)
English: When only considering relapse, the CIDP relapse rates were 19.0 % for 0.4 g/kg bw Hizentra and 33.3 % for 0.2 g/kg bw Hizentra compared with 56.1 % for placebo (p < 0.001 or p = 0.012, respectively).
Maltese: Meta titqies ir-rikaduta biss, ir-rati ta' rikaduta ta' CIDP kienu 19.0 % għal Hizentra 0.4 g/kg piż tal-ġisem u 33.3 % għal Hizentra 0.2 g/kg piż tal-ġisem meta mqabbla ma' 56.1 % għall-plaċebo (p < 0.001 jew p = 0.012, rispettivament).
English: In the second patient group receiving Hizentra via pump-assisted administration (n=18), weekly Hizentra infusions were administered with 25, 50, 75 and 100 ml/hour/site flow rate.
Maltese: Fit-tieni grupp ta' pazjenti li ngħataw Hizentra permezz ta' għoti bil-pompa (n=18), ingħataw infużjonijiet kull ġimgħa ta' Hizentra b'rati ta' fluss ta' 25, 50, 75 and 100 mL/siegħa/sit.
English: Postmarketing experience with Hizentra in patients ≥ 65 years of age shows an overall similar safety profile in this age group as in younger patients.
Maltese: Esperjenza ta' wara t-tqegħid fis-suq b'Hizentra f'pazjenti b'età ta' ≥ 65 sena turi profil globali ta' sigurtà f'dan il-grupp ta' età simili għal dak ta' pazjenti iżgħar.
English: Hizentra is also available in packs of 1, 10 or 20 vials.
Maltese: Hizentra huwa disponibbli wkoll f'pakketti ta' kunjett 1, 10 kunjetti jew 20 kunjett.
English: Subjects generally used 4 infusion sites in parallel (up to 8 sites in parallel).
Maltese: L-individwi ġeneralment użaw 4 postijiet tal-infużjoni fl-istess ħin (sa 8 postijiet fl-istess ħin).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1 (ara sezzjoni 4.4).
English: • by manual push with a syringe.
Maltese: • imbuttar manwali b'siringa.
English: EU/1/11/687/004 EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012 EU/1/11/687/013 EU/1/11/687/014
Maltese: EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012
English: Responder: in the pump-assisted group a subject who performed ≥3 valid infusions out of 4 for an infusion parameter; in the manual push group a subject who performed ≥60 % of valid infusions for an infusion parameter.
Maltese: Dak li rrisponda: fil-grupp tal-pompa individwu li kellu ≥3 infużjonijiet validi minn 4 għal parametru ta' infużjoni; fil-grupp tal-imbuttar manwali, individwu li kellu ≥60 % tal-infużjonijiet validi għal parametru ta' infużjoni.
English: Immunomodulatory therapy in CIDP
Maltese: Terapija immunomodulatorja f'CIDP
English: 9 Infuse Hizentra
Maltese: 9 Agħti l-infużjoni ta' Hizentra
English: Hizentra belongs to the class of medicines called human normal immunoglobulins.
Maltese: Hizentra jappartjeni fil-kategorija ta' mediċini li jissejħu immunoglobulini umani normali.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini: http://www.ema.europa.eu/.
English: To assess the safety and tolerability of higher infusion rates applied via the manual push and pumpassisted administration, 49 PID subjects aged 2 to 75 years were enrolled in an open-label, multicentre, parallel-arm, nonrandomised phase IV HILO (Hizentra Label Optimization) study and treated with Hizentra for at least 12 weeks (11 paediatric patients aged 2 to <18, 35 adult patients aged 18 to 65, and 3 geriatric patients aged >65 years).
Maltese: IV HILO (Hizentra Label Optimization) open-label, b'aktar minn ċentru wieħed, parallel-arm, fejn lindividwi ma ġewx magħżula b'mod arbitrarju u ġew ittratti b'Hizentra għal mill-inqas 12-il ġimgħa (11-il pazjent pedjatriku minn 2 sa <18-il sena, 35 pazjent adult minn 18 sa 65 sena, u 3 persuni anzjani ta' >65 sena).
English: The syndrome usually begins within several hours to 2 days following immune globulin treatment.
Maltese: Is-sindrome normalment jibda fi żmien diversi sigħat sa jumejn wara trattament b'immunoglobulini.
English: Pack sizes of 1, 10 or 20 vials: 1 g / 5 ml
Maltese: Daqsijiet tal-pakkett għall-1, 10 jew 20 kunjett: 1 g / 5 ml
English: In the US prospective open label, single arm and multicentre study, a total of 49 subjects with primary immunodeficiency syndromes aged between 5 and 72 years old were treated with Hizentra for up to 15 months.
Maltese: Fl-istudju fl-Istati Uniti, b'aktar minn ċentru wieħed, prospettiv, open-label u single arm, total ta' 49 individwu ta' bejn l-etajiet ta' 5 snin u 72 sena b'sindromi ta' immunodefiċjenza primarja kienu ttrattati b'Hizentra għal sa 15-il xahar.
English: Hypogammaglobulinaemia in patients, pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).
Maltese: (haematopoietic stem cell transplantation - HSCT).
English: ► if you suffer from hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood).
Maltese: ► jekk tbati b'iperprolinemija (disturb ġenetiku li jikkawża livelli għolja ta' amino acid proline fid-demm).
English: • Pain related to the musculature and bones (musculoskeletal pain)
Maltese: • Uġigħ marbut mal-muskoli u mal-għadam (uġigħ muskoluskeletriku)
English: In the clinical studies with CIDP patients, 61 subjects >65 years of age were treated with Hizentra.
Maltese: Fl-istudji kliniċi b'pazjenti b'CIDP, 61 individwu b'età ta' >65 sena kienu ttrattati b'Hizentra.
English: AMS is characterised by the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting.
Maltese: AMS hija kkaratterizzata mis-sinjali u s-sintomi li ġejjin: uġigħ ta' ras qawwi, ebusija fl-għonq, ħedla ta' ngħas, deni, fotofobija, dardir, u rimettar.
English: No differences were seen in the pharmacokinetic parameters between adult and paediatric PID study patients.
Maltese: Ma dehru l-ebda differenzi fil-parametri farmakokinetiċi bejn pazjenti adulti u pedjatriċi tal-istudju dwar PID.
English: Date of first authorisation: 14 April 2011 Date of first renewal: 18 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 t'April, 2011
English: In the European pivotal prospective open label, single arm and multicentre study, a total of 51 subjects with primary immunodeficiency syndromes aged between 3 and 60 years old were treated with Hizentra for up to 41 weeks.
Maltese: Fl-istudju Ewropew, b'aktar minn ċentru wieħed, prospettiv, open-label, single arm u importanti, total ta' 51 individwu ta' bejn l-etajiet ta' 3 snin u 60 sena b'sindromi ta' immunodefiċjenza primarja kienu ttrattati b'Hizentra għal mhux aktar minn 41 ġimgħa.
English: 50 ml/site
Maltese: 50 mL/sit
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 rassiguranti dwar in-nuqqas ta' trasmissjoni ta' epatite A jew il-parvovirus B19 permezz tal-immunoglobulini, u wieħed jassumi wkoll li l-kontenut tal-antikorpi għandu sehem importanti fis-sigurtà virali.
English: Subjects in both Hizentra dose groups remained stable in electrophysiology parameters.
Maltese: L-individwi fiż-żewġ gruppi tad-dożi ta' Hizentra baqgħu stabbli fil-parametri tal-elettrofiżjoloġija.
English: Sustained IgG trough levels with mean concentrations of 7.99 - 8.25 g/l were thereby achieved throughout the treatment period.
Maltese: Livelli sostnuti l-aktar baxxi ta' IgG b'konċentrazzjonijiet medji ta' 7.99 - 8.25 g/l kienu b'hekk miksuba matul il-perjodu ta' trattament.
English: The mean efficacy evaluation period was 125.8 days (range: 1-330) in the 0.2 g/kg, and 196.1 days (range: 1-330) in the 0.4 g/kg bw group.
Maltese: Il-perjodu medju ta' evalwazzjoni tal-effikaċja kien ta' 125.8 ijiem (firxa: 1-330) fil-grupp ta' 0.2 g/kg, u 196.
English: No overall differences in the pharmacokinetic parameters were observed between CIDP subjects >65 years and subjects 18 to 65 years of age.
Maltese: Ma kienu osservati l-ebda differenzi globali fil-parametri farmakokinetiċi bejn individwi b'CIDP b'età ta' >65 sena u individwi b'età ta' 18 sa 65 sena.
English: Please refer to section 4.4 for details on risk factors and monitoring recommendations.
Maltese: Jekk jogħġbok irreferi għal sezzjoni 4.4 għal dettalji dwar fatturi ta' riskju u rakkomandazzjonijiet dwar monitoraġġ.
English: Posology Adults and children (0-18 years)
Maltese: Adulti u tfal (0-18-il sena) Terapija ta' sostituzzjoni
English: Hizentra 200 mg/ml solution for subcutaneous injection Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe
Maltese: Hizentra 200 mg/ml soluzzjoni għall-injezzjoni taħt il-ġilda Hizentra 200 mg/ml soluzzjoni għall-injezzjoni taħt il-ġilda f'siringa mimlija għal-lest
English: Hizentra is also used in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a form of autoimmune disease.
Maltese: (CIDP, chronic inflammatory demyelinating polyneuropathy), forma ta' marda awtoimmuni. CIDP
English: • the batch number of the medicine, and
Maltese: • in-numru tal-lott tal-mediċina, u
English: Data from prospective clinical trials on the use of human normal immunoglobulin in breast feeding women is limited.
Maltese: Hemm data limitata minn provi kliniċi prospettivi dwar l-użu ta' immunoglobina normali umana f'nisa li qed ireddgħu.
English: Contact your doctor if you experience the following signs and symptoms: severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomitingafter receiving Hizentra.
Maltese: Ikkuntattja lit-tabib tiegħek jekk ikollok is-sinjali u s-sintomi li ġejjin: uġigħ ta' ras qawwi, ebusija fl-għonq, ħedla ta' ngħas, deni, fotofobija, dardir, u rimettar wara li tirċievi Hizentra.
English: For all patients who received 0.4 g/kg bw in the PATH extension study, 9.7 % (7/72 patients) had a relapse.
Maltese: Għall-pazjenti kollha li rċevew 0.4 g/kg bw fl-istudju ta' estensjoni PATH, 9.7 % (7/72 pazjent) kellhom rikaduta.
English: Other medicines and Hizentra
Maltese: Mediċini oħra u Hizentra
English: If the points above do not apply for you it is recommended that you are observed for at least 20 minutes after administration.
Maltese: Il-pazjenti l-oħrajn kollha għandhom ikunu osservati għal mill-inqas 20 minuta wara li tingħata.
English: Hizentra was evaluated in 68 paediatric subjects with PID 2 to <12 years of age and in 57 paediatric subjects 12 to <18 years of age.
Maltese: Hizentra ġie evalwat f'68 individwu pedjatriku b'PID ta' età minn 2 sa <12-il sena u f'57 individwu pedjatriku ta' età minn 12 sa <18-il sena.
English: Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe human normal immunoglobulin (SCIg)
Maltese: Hizentra 200 mg/ml soluzzjoni għall-injezzjoni għal taħt il-ġilda immunoglobulina normali umana (SCIg)
English: Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Maltese: Terapija tas-sostituzzjoni f'adulti, tfal u adolexxenti (0-18-il sena) b': - Sindromi ta' immunodefiċjenza primarja bi produzzjoni ta' antikorpi indeboliti (ara sezzjoni Ipogammaglobulinemija u infezzjonijiet batteriċi rikorrenti f'pazjenti b'lewkimja limfoċitika kronika (chronic lymphocytic leukaemia, CLL) li fuqhom antibijotiċi profilattiċi ma jaġġixux jew huma kontraindikati.
English: In immunodeficiency, adequate doses of Hizentra may restore abnormally low immunoglobulin G antibody levels to the normal range and thus help against infections.
Maltese: Fl-immunodefiċjenza, dożi adegwati ta' Hizentra jistgħu iżidu għan-normal livelli baxxi ta' antikorpi ta' immunoglobulina G u b'hekk jgħinu kontra l-infezzjonijiet.
English: • Do not store above 25 °C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 25 °C.