FrancophonIA/ELRC3.0 huggingface dataset:
English: Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion) EMA/CHMP/735863/2009
Maltese: Mistoqsijiet u tweġibiet dwar Levact u ismijiet assoċjati (bendamustina kloridrat, 2.5 mg/ml, trab għal konċentrat għal soluzzjoni għal infużjoni) EMA/CHMP/735863/2009
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Levact outweigh its risks, and that the marketing authorisation can be granted in Germany and in the following Member States: Austria, Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom.
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Levact jisbqu r-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fil-Ġermanja u fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, id-Danimarka, il-Finlandja, Franza, l-Irlanda, l-Italja, ilLussemburgu, in-Norveġja, il-Polonja, Spanja u r-Renju Unit.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Denmark, Finland, France, Ireland, Italy, Luxembourg, Norway, Poland, Spain and the United Kingdom).
Maltese: F'din il-proċedura Stat Membru partikulari (l-‘Istat Membru ta' referenza', f'dan il-każ il-Ġermanja) jevalwa mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra ( l-‘Istati Membri ikkonċernati', f'dan ilkaż l-Awstrija, il-Belġju, id-Danimarka, il-Finlandja, Franza, l-Irlanda, l-Italja, il-Lussemburgu, inNorveġja, il-Polonja, Spanja u r-Renju Unit).
English: What is Levact?
Maltese: X'inhu Levact?
English: 7 July 2010
Maltese: 07 ta' Lulju 2010
English: • non-Hodgkin's lymphoma (a cancer of the lymph tissue, part of the immune system) in patients whose cancer got worse during or following treatment containing rituximab (another anticancer medicine);
Maltese: • limfoma mhux ta' Hodgkin (kanċer tat-tessut limfatiku, parti mis-sistema immunitarja) f'pazjenti li l-kanċer tagħhom ikun iggrava waqt jew wara l-kura b'rituximab (mediċina oħra kontra l-kanċer);
English: Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)
Maltese: Mistoqsijiet u tweġibiet dwar Levact u ismijiet assoċjati (bendamustina kloridrat, 2.5 mg/ml, trab għal konċentrat għal soluzzjoni għal infużjoni)
English: The active substance in Levact, bendamustine hydrochloride, belongs to a group of anticancer medicines called ‘alkylating agents'.
Maltese: Is-sustanza attiva f'Levact, jiġifieri l-bendamustina kloridrat, tagħmel parti minn grupp ta' mediċini kontra l-kanċer li jissejħu ‘aġenti alkilanti'.
English: The grounds for the referral were that one Member State, the United Kingdom, could not approve the indication non-Hodgkin's lymphoma, and two Member States, Belgium and France, could not approve the indication multiple myeloma because not enough data on the effectiveness of this medicine were available to support these indications.
Maltese: Ir-referenza kienet meħtieġa għax Stat Membru minnhom, ir-Renju Unit, ma setax japprova lindikazzjoni relatata mal-limfoma mhux ta' Hodgkin, u żewġ Stati Membri, il-Belġju u Franza, ma setgħux japprovaw l-indikazzjoni relatata mal-majeloma multipla minħabba li ma kienx hemm biżżejjed tagħrif disponibbli dwar l-effikaċja ta' din il-mediċina li seta' jappoġġa dawn l-indikazzjonijiet.
English: Levact is an anticancer medicine.
Maltese: Levact huwa mediċina kontra l-kanċer.
English: Astellas Pharma GmbH submitted Levact to the German medicines regulatory agency for a decentralised procedure.
Maltese: GmbH issottomettiet il-mediċina Levact lill-aġenzija regolatorja tal-mediċini Ġermaniża għal proċedura deċentralizzata.
English: The CHMP assessed the two clinical studies presented by the company to support the multiple myeloma and non-Hodgkin's lymphoma indications.
Maltese: Is-CHMP evalwa ż-żewġ studji kliniċi ppreżentati mill-kumpanija biex jappoġġa l-indikazzjonijiet relatati mal-majeloma multipla u mal-limfoma mhux ta' Hodgkin.
English: • chronic lymphocytic leukaemia (a cancer of a type of white blood cell called lymphocytes) in patients for whom treatment with fludarabine (another anticancer medicine) is not appropriate;
Maltese: • lewkimja limfoċitika kronika (kanċer ta' tip ta' ċelloli bojod tad-demm li jissejħu limfoċiti) f'pazjenti fejn kura b'fludarabine (mediċina oħra kontra l-kanċer) mhijiex adatta;
English: • multiple myeloma (a cancer of the bone marrow) in combination with prednisone in patients older than 65 years who are not eligible for stem-cell transplantation and cannot be treated with thalidomide or bortezomib (other anticancer medicines).
Maltese: 65 sena li ma jkunux eliġibbli għal trapjant ta' ċelloli staminali u li ma jkunux jistgħu jiġu kkurati b'talidomide jew b'borteżomib (mediċini oħra kontra l-kanċer).
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 2 October 2009.
Maltese: Madankollu l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini Ġermaniża rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fit-2 ta' Ottubru 2009.
English: The Committee therefore recommended that Levact be granted marketing authorisation in Germany and all concerned Member States for all the indications that were applied for.
Maltese: Għalhekk il-Kumitat irrakkomanda li Levact jingħata awtorizzazzjoni għat-tqegħid fis-suq fil-Ġermanja u fl-Istati Membri kkonċernati kollha għall-indikazzjonijiet kollha li kienet saret applikazzjoni għalihom.
English: 14 January 2010 and 17 February 2010
Maltese: It-tweġibiet tal-kumpanija ngħataw nhar: 14 ta' Jannar 2010 u 17 ta' Frar 2010
English: The full EPAR for Trumenba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Trumenba
Maltese: Informazzjoni oħra dwar Trumenba
English: The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the site of the injection, headache, tiredness, chills, diarrhoea, nausea (feeling sick), and muscle or joint pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Trumenba (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma uġigħ, ħmura jew nefħa fis-sit tal-injezzjoni, uġigħ ta' ras, għeja, tertir ta' bard, dijarea, dardir (tħossok ma tiflaħx), u uġigħ fil-muskoli u fil-ġogi.
English: Why is Trumenba approved?
Maltese: Għaliex ġie approvat Trumenba?
English: Trumenba meningococcal group B vaccine (recombinant, adsorbed)
Maltese: Sommarju tal-EPAR għall-pubbliku vaċċin meningokokkali tal-grupp B (rikombinanti, adsorbit)
English: The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection.
Maltese: L-ewwel studju involva madwar 3,600 parteċipant ta' età bejn 10 u 18il sena, u t-tieni studju involva madwar 3,300 żagħżugħ/a ta' bejn 18 u 25 sena; l-ebda parteċipant ma kien ġie vvaċinat preċedentement kontra N. meningitidis grupp B.
English: What are the risks associated with Trumenba?
Maltese: X'inhuma r-riskji assoċjati ma' Trumenba?
English: Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested.
Maltese: L-antikorpi ġew prodotti fi kwantitajiet biżżejjed biex jipprovdu protezzjoni kontra l-4 razez tat-test ewlenin f'bejn 80 u 90 % ta' dawk fl-ewwel studju, skont ir-razza; 84 % ta' dawk li ngħataw il-vaċċin kellhom antikorpi protettivi kontra l-4 razez kollha meta ġew ittestjati.
English: In the second study sufficient amounts of antibodies were produced in 79 to 90% of cases, and protective levels of antibodies against all 4 strains were seen in 85% of participants.
Maltese: Fit-tieni studju, ġew prodotti ammonti biżżejjed ta' antikorpi f'79 sa 90 % tal-każi, u dehru livelli protettivi ta' antikorpi kontra l4 razez kollha f'85 % tal-parteċipanti.
English: In patients at greater risk of invasive meningococcal disease, an additional booster dose may be considered later on.
Maltese: F'pazjenti li għandhom riskju ogħla ta' marda meningokokkali invażiva, aktar tard tista' tiġi kkunsidrata doża booster addizzjonali.
English: Trumenba has been shown to trigger the production of protective levels of antibodies against Neisseria meningitidis group B in two main studies.
Maltese: F'żewġ studji ewlenin, Trumenba ntwera li jiskatta l-produzzjoni ta' livelli protettivi ta' antikorpi kontra Neisseria meningitidis grupp B.
English: It is available in a pre-filled syringe and is given by injection into a muscle, preferably in the shoulder.
Maltese: Dan jiġi f'siringa mimlija għal-lest u jingħata b'injezzjoni ġol-muskolu, preferibbilment ġol-ispalla.
English: Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Maltese: Trumenba huwa vaċċin li jintuża biex jipproteġi individwi minn 10 snin kontra marda meningokokkali invażiva kkawżata minn grupp ta' batterji msejjaħ Neisseria meningitidis grupp B.
English: Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
Maltese: Twettqu wkoll studji ta' sostenn, li wrew li 2 dożi tal-vaċċin kisbu rispons tal-antikorp ġeneralment simili għal 3 dożi, u li minkejja li l-livelli protettivi tal-antikorp naqsu maż-żmien, dawn jistgħu jitjiebu b'doża booster addizzjonali wara kuri ta' kemm b'2 dożi kif ukoll bi 3 dożi.
English: Trumenba contains two components, proteins that are found in the outer coats of Neisseria meningitidis group B bacteria.
Maltese: Trumenba fih żewġ komponenti, proteini li jinstabu fil-kisjiet ta' barra tal-batterja Neisseria meningitidis grupp B.
English: What is Trumenba and what is it used for?
Maltese: 'Trumenba, ara l
English: The studies also looked at response to 10 other, secondary strains of N. meningitidis group B.
Maltese: L-istudji ħarsu wkoll lejn ir-rispons għal 10 razez sekondarji oħra ta' N. meningitidis grupp B.
English: The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule.
Maltese: Id-dejta disponibbli indikat li Trumenba għandu jipprovdi protezzjoni vasta kontra r-razez ta' Neisseria meningitidis grupp B li bħalissa jinstabu fl-Ewropea, sew jekk jingħata fi skeda ta' 3 dożi jew ta' 2 dożi.
English: When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Maltese: Meta l-persuna mbagħad tiġi esposta għall-batterju, dawn l-antikorpi flimkien ma' komponenti oħra tas-sistema immuni jkunu kapaċi joqtlu l-batterja u jgħinu fil-protezzjoni kontra l-mard.
English: Initial treatment may either involve 2 injections at least 6 months apart, or 2 injections at least 1 month apart followed by a third injection at least 4 months later.
Maltese: Ilkura inizjali tista' tinvolvi jew 2 injezzjonijiet tal-inqas 6 xhur minn xulxin, jew 2 injezzjonijiet tal-inqas xahar minn xulxin segwiti mit-tielet injezzjoni tal-inqas 4 xhur wara.
English: This is a summary of the European public assessment report (EPAR) for Trumenba.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spinal cord) and septicaemia (blood infection).
Maltese: Mard invażiv iseħħ meta l-batterji jinfirxu mal-ġisem u jikkawżaw infezzjonijiet serji bħal meninġite (infezzjoni tal-membrani li jiċċirkondaw il-moħħ u s-sinsla tad-dahar) u settiċemija (infezzjoni taddemm).
English: How is Trumenba used?
Maltese: Kif jintuża Trumenba?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-vaċċini jaħdmu billi "jgħallmu" lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-mard.
English: It may harm them,
Maltese: Irrekordja l-infużjoni:
English: Terminal half life [days]
Maltese: Half life terminali [jiem]
English: 10 minutes
Maltese: 10 minuti
English: Tmax [days]
Maltese: Tmax [jiem]
English: Protein (grams)
Maltese: Proteina (grammi)
English: Date of first authorisation: 16 May 2013 Date of renewal: 8 Jan 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 16 Mejju 2013 Data ta' tiġdid: 8 Jannar 2018
English: See sections 4.2 and 4.8.
Maltese: Ara sezzjonijiet 4.2 u 4.8.
English: This may take up to 60 minutes.
Maltese: Dan jista' jieħu sa 60 minuta.
English: Interval/Minutes
Maltese: Intervall/Minuti
English: Volume (ml)
Maltese: Volum (ml)
English: 10.4 (9.4 to 11.2)
Maltese: 10.4 (9.4 sa 11.2)
English: 35.7 (32.4 to 40.4)
Maltese: 35.7 (32.4 sa 40.4)
English: MedDRA System Organ Class (SOC)
Maltese: Sistema tal-klassifika tal-organi fid-database MedDRA (SOC)
English: (purity of at least 98% IgG)
Maltese: (purità ta' mill-inqas 98% IgG)
English: IVIG 10% Median (95% Cl) N=68
Maltese: IVIG 10% Medjan (95% Cl) N=68
English: 0.1 (0.1 to 0.1)
Maltese: 0.1 (0.1 sa 0.1)
English: Aseptic meningitis syndrome (AMS)
Maltese: Sindromu ta' meninġite asettika (AMS)
English: Direct Coombs' test positive
Maltese: Test ta' Coombs dirett pożittiv
English: Sodium phosphate dibasic Human albumin
Maltese: Sodium phosphate dibasic
English: 93.9 (89.1 to 102.1)
Maltese: 93.9 (89.1 sa 102.1)
English: Allow to dry (at least 30 seconds).
Maltese: Ħalliha tinxef (għal mill-inqas 30 sekonda).
English: Produced from the plasma of human donors.
Maltese: Prodott mill-plasma ta' donaturi umani.
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni dwar użu pedjatriku.
English: Baxalta Innovations GmbH A-1221 Vienna, Austria
Maltese: Baxalta Innovations GmbH A-1221 Vienna, L-Awstrija
English: 45.3 (41.0 to 60.2)
Maltese: 45.3 (41.0 sa 60.2)
English: OUTER CARTON (2.5 G, 5 G, 10 G, 20 G AND 30 G)
Maltese: KARTUNA TA' BARRA (2.5 G, 5 G, 10 G, 20 G U 30 G)
English: Human normal immunoglobulin (SCIg)
Maltese: Immunoglobulina umana normali (SCIg)
English: Hypersensitivity to IG 10%
Maltese: Sensittività eċċessiva għal IG 10%
English: HyQvia Median (95% Cl) N=60
Maltese: HyQvia Medjan (95% Cl) N=60
English: • Recombinant human hyaluronidase (rHuPH20) Recombinant human hyaluronidase is a purified glycoprotein of 447 amino acids produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: • Hyaluronidase umana rikombinanti (rHuPH20) Hyaluronidase umana rikombinanti huwa glikoproteina ppurifikata ta' 447 amino aċidi prodotti fiċ-ċelloli tal-Ovarji ta' Ħamsters Ċiniżi (CHO) permezz ta' teknoloġija rikombinanti tad-DNA.
English: The maximum IgA content is 140 micrograms/ml.
Maltese: Il-kontenut massimu ta' IgA huwa ta' 140 mikrogramma/ml.
English: Recombinant human hyaluronidase (rHuPH20) vial Sodium chloride
Maltese: Kunjett tal-hyaluronidase uman rimkombinanti (rHuPH20) Sodium chloride
English: The safety of HyQvia was evaluated in 4 clinical studies (160602, 160603, 160902, and 161101) in 124 unique patients with PID receiving 3,202 infusions.
Maltese: Is-sigurtà ta' HyQvia kienu evalwati f'4 studji kliniċi (160602, 160603, 160902, u 161101) f'124 pazjent uniku b'PID li kienu qegħdin jirċievu 3,202 infużjonijiet.
English: Replacement therapy in adults, children and adolescents (0-18 years) in:
Maltese: Terapija ta' sostituzzjoni f'adulti, tfal u adolexxenti (0-18-il sena) f':
English: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
Maltese: • Sindromi ta' immunodefiċjenza primarja b'indeboliment tal-produzzjoni ta' antikorpi (ara sezzjoni 4.4).
English: National unique code included.
Maltese: Kodiċi uniku nazzjonali inkluż.
English: 1.4 (1.2 to 1.4)
Maltese: 1.4 (1.2 sa 1.4)
English: Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Maltese: Kull kunjett ta' 25 ml fih: 2.5 g ta' immunoglobulina umana normali Kull kunjett ta' 50 ml fih: 5 g ta' immunoglobulina umana normali Kull kunjett ta' 100 ml fih: 10 g ta' immunoglobulina umana normali Kull kunjett ta' 200 ml fih: 20 g ta' immunoglobulina umana normali Kull kunjett ta' 300 ml fih: 30 g ta' immunoglobulina umana normali
English: Rare (≥1/10,000 to
Maltese: Rari (≥1/10,000 sa
English: The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hi skont is-Sistema tal-Klassifika tal-Organi fid-database MedDRA (SOC and Preferred Term Level).
English: Pharmacotherapeutic group (human normal immunoglobulin): immune sera and immunoglobulins: immunoglobulins, normal human, ATC code: J06BA01
Maltese: Kategorija farmakoterapewtika (immunoglobulina umana normali): sera immuni u immunoglobulini: immunoglobulini, normali umani, Kodiċi ATC:
English: The overall rate of infections was less during HyQvia administration than during the three months intravenous administration of IG 10%: the point estimate of the annualized rate of all infections was 2.97 (95% CI: 2.51 to 3.47) for HyQvia and 4.51 (95% CI: 3.50 to 5.69) for intravenous IG 10% infusions.
Maltese: Ir-rata globali ta' infezzjonijiet kienet inqas matul l-għoti ta' HyQvia milli matul it-tliet xhur ta' għoti ta' IG 10% ġol-vini: l-istima tal-punt tar-rata annwali tal-infezzjonijiet kollha kienet ta' 2.97 (95% CI: 2.51 sa 3.47) għal HyQvia u ta' 4.51 (95% CI: 3.50 sa 5.69) għal infużjonijiet ta' IG 10% ġol-vini.
English: EU/1/13/840/001 EU/1/13/840/002 EU/1/13/840/003 EU/1/13/840/004 EU/1/13/840/005
Maltese: EU/1/13/840/001 EU/1/13/840/002 EU/1/13/840/003
English: 90.52 (83.8 to 9)
Maltese: 52 (83.8 sa 98.4)
English: VIAL LABEL HUMAN NORMAL IMMUNOGLOBULIN (5 G, 10 G, 20 G AND 30 G)
Maltese: TIKKETTA TAL-KUNJETT IMMUNOGLOBULINA UMANA NORMALI 10% (5 G, 10 G, 20 G U 30 G)
English: Solution for infusion (infusion).
Maltese: Soluzzjoni għal infużjoni (infużjoni).
English: Local reactions (total):
Maltese: Reazzjonijiet lokali (totali)a:
English: 1 vial recombinant human hyaluronidase 1.25 ml
Maltese: 1 kunjett hyaluronidase umana rikombinanti 1.25 ml
English: Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma.
Maltese: Immunoglobulina umana normali u albumina tas-serum uman (stabilizzaturi tal-hyaluronidase umana rikombinanti) huma prodotti mill-plasma umana.
English: SC use only.
Maltese: Użu SC biss.
English: 5.0 (3.3 to 5.1)
Maltese: 5.0 (3.3 sa 5
English: HyQvia 100 mg/ml
Maltese: HyQvia 100 mg/m
English: Erythema, rash (including erythematous, papular, maculo-papular), pruritus, urticaria
Maltese: Eritema, raxx, (li jinkludi raxx eritematuż, papulari, u makulo-papulari), ħakk, urtikarja
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5
English: Myalgia, musculoskeletal chest pain
Maltese: Mijalġija, uġigħ muskuloskeletali fis-sider
English: Human normal immunoglobulin 10%
Maltese: Immunoglobulina umana normali 10%
English: Recombinant human hyaluronidase (rHuPH20) vial 1.25, 2.5, 5, 10 or 15 ml of solution in a vial (Type I glass) with a stopper (chlorobutyl rubber).
Maltese: Kunjett tal-hyaluronidase uman rikombinanati (rHuPH20) 1.25, 2.5, 5, 10 jew 15 ml ta' soluzzjoni f'kunjett (Ħġieġ Tip I) b'tapp (lastiku chlorobutyl).
English: Frequencies per infusion have been evaluated using the following convention: 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), not known (cannot be estimated from available data).
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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Human normal immunoglobulin (IG 10%) vial 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl rubber).
Maltese: Kunjett tal-immunoglobulina umana normali (IG 10%) 25, 50, 100, 200 jew 300 ml ta' soluzzjoni f'kunjett (Ħġieġ Tip I) b'tapp (lastiku bromobutyl).
English: 10.1 (9.5 to 10.9)
Maltese: 10.1 (9.5 sa 10.
English: The active substance of HyQvia is human normal immunoglobulin.
Maltese: Is-sustanza attiva ta' HyQvia hija immunoglobulina umana normali.
English: Subjects < 40 kg
Maltese: Individwi li jiżnu < 40 kg
English: Frequency of Adverse Reactions (ADRs) with HyQvia
Maltese: Frekwenza ta' reazzjonijiet avversi (ADRs) bi HyQvia
English: Paresthesia
Maltese: Parestesija
English: 90-degree angle to skin
Maltese: Angola ta' 90 grad mal-ġilda
English: The safety of IG 10% has been demonstrated in several non-clinical studies.
Maltese: Is-sigurtà ta' IG 10% intweriet f'diversi studji mhux kliniċi.
English: Clinical efficacy and safety
Maltese: Effikaċja u sigurtà klinika
English: Antibodies against recombinant human hyaluronidase A total of 13 out of 83 subjects who participated in pivotal study developed an antibody capable of binding to recombinant human hyaluronidase (rHuPH20) at least once during the clinical study.
Maltese: Antikorpi kontra hyaluronidase umana rikombinanti Total ta' 13 minn 83 suġġett li pparteċipaw fi studju pivotali żviluppaw antikorp li kapaċi jeħel ma' hyaluronidase umana rikombinanti (rHuPH20) għallinqas darba matul l-istudju kliniku.
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of opsonising and neutralizing antibodies against infectious agents.
Maltese: L-immunoglobulina umana normali fiha prinċipalment l-immunoglobulina G (IgG) bi spettru wiesa' ta' opsonising u antikorpi newtralizzanti kontra aġenti infettivi.
English: Hypersensitivity to the active substance (IgG) or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Sensittività eċċessiva għas-sustanza attiva (IgA) jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara sezzjoni 4.4).
English: The recombinant human hyaluronidase of HyQvia contains small amounts (4.03 mg per ml) of sodium.
Maltese: Il-hyaluronidase umana rikombinanti ta' HyQvia fiha ammonti żgħar (4.03 mg għal kull ml) ta' sodium.
English: Information on the source material of HyQvia
Maltese: Informazzjoni dwar il-materjal li minnu jsir HyQvia