FrancophonIA/ELRC3.0 huggingface dataset:
English: Passive transmission of antibodies to erythrocyte´s surface antigens, (e.g., A, B, D) may interfere with some serological tests for red cell antibodies for example the direct antiglobulin test (DAT, direct Coombs' test).
Maltese: It-trasmissjoni passiva ta' antikorpi lil antiġeni tl-wiċċ tal-eritroċiti, (eż., A, B, D) tista' tinterferixxi ma' xi testijiet seroloġiċi għall-antikorpi taċ-ċelloli ħomor pereżempju t-test dirett tal-antiglobulina (DAT, it-test dirett ta' Coombs).
English: In the clinical study with HyQvia, no differences in the plasma IgG trough levels were observed between adult and paediatric patients.
Maltese: Fl-istudju kliniku bi HyQvia, ma ġiet osservata l-ebda differenza fil-livelli minimi ta' IgG fil-plasma bejn pazjenti adulti u pedjatriċi.
English: Human normal immunoglobulin 10% belongs to a class of medicines called “human normal immunoglobulins”.
Maltese: L-immunoglobulina umana normali 10% tappartjeni għal kategorija ta' mediċini msejħa “immunoglobulini normali umani”.
English: Sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid disodium, calcium chloride, water for injections.
Maltese: Kunjett tal-hyaluronidase umana rikombinanti: hyaluronidase umana, Sodium chloride, sodium phosphate, albumina umana, ethylenediaminetetraacetic acid disodium, calcium chloride, ilma għall-injezzjonijiet.
English: Glycine, water for injections.
Maltese: Glycine, ilma għall-injezzjonijiet.
English: A-1221 Vienna, Austria
Maltese: A-1221 Vienna, L-Awstrija
English: VIAL LABEL RECOMBINANT HUMAN HYALURONIDASE (1.25 ML)
Maltese: TIKKETTA TAL-KUNJETT TA' HYALURONIDASE UMANA RIKOMBINANTI (1.25 ML)
English: Do not use heating devices including microwaves.
Maltese: Tużax tagħmir tat-tisħin inklużi microwaves.
English: The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients.
Maltese: L-esponiment globali kombinata ta' pazjenti b'PID fiż-żewġ studji kien ta' 187.69 sena ta' pazjent; l-itwal esponiment għall-adulti kien ta' 3.8 snin, u ta' 3.3 snin għal pazjenti pedjatriċi.
English: It has a distribution of IgG subclasses closely proportional to that in native human plasma.
Maltese: Għandha distribuzzjoni ta' subklassijiet ta' IgG kważi proporzjonali għal dik fil-plasma umana.
English: The rHuPH20 may be hand-pushed or infused by a pump.
Maltese: L-rHuPH20 jista' jkun imbuttat bl-idejn jew infuż permezz ta' pompa.
English: Hyaluronan is a polysaccharide found in the intercellular matrix of the connective tissue.
Maltese: Hyaluronan huwa polisakkarid li jinstab fil-matriċi interċellulari tat-tessut konnettiv.
English: Subsequent 2-3 Infusions (ml/hour/infusion site)
Maltese: 2-3 Infużjonijiet Sussegwenti (ml/siegħa/sit talinfużjoni)
English: To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (> 6 g/l).
Maltese: Biex ir-rata ta' infezzjoni titnaqqas, jista' jkun hemm bżonn li d-dożaġġ jiżdied u jiġu mmirati livelli minimi ogħla (> 6 g/l).
English: It is usually prepared from pooled human plasma from not fewer than 1,000 donations.
Maltese: Ġeneralment tiġi ppreparata minn ġabriet ta' plasma umana minn mhux anqas minn 1,000 donazzjoni.
English: Subjects ≥ 40 kg
Maltese: Individwi li jiżnu ≥ 40 kg
English: HyQvia was evaluated in 24 paediatric patients, including 13 patients between 4 and < 12 years and 11 between 12 and < 18 years, who were treated for up to 3.3 years with an overall safety experience equivalent to 48.66 patient-years (as described in section Clinical efficacy and safety).
Maltese: HyQvia kien evalwat f'24 pazjent pedjatriku, li kienu jinkludu 13-il pazjent bejn l-4 u < 12 sena u 11 bejn it-12 u < 18-il sena, li kienu rċevew kura sa 3.3 snin b'esperjenza globali tas-sigurtà ekwivalenti għal 48.66 sena ta' pazjent (kif deskritt fis-sezzjoni Effikaċja klinika u sigurtà).
English: The results of the study showed a rate of validated, acute, serious bacterial infections per year during HyQvia treatment of 0.025 (upper limit of the one-sided 99% confidence interval 0.046).
Maltese: Ir-riżultati tal-istudju wrew rata ta' infezzjonijiet batteriċi serji akuti validati kull sena matul kura bi HyQvia ta' 0.025 (limitu ta' fuq tal-intervall ta' fiduċja one-sided ta' 99% ta' 0.046).
English: HyQvia is a dual vial unit consisting of one vial of human normal immunoglobulin (Immune Globulin 10% or IG 10%) and one vial of recombinant human hyaluronidase (rHuPH20).
Maltese: HyQvia huwa unità b'żewġ kunjetti li tikkonsisti minn kunjett uniku ta' immunoglobulina umana normali (Globulina Immuni 10% jew IG 10%) u kunjett uniku ta' hyaluronidase umana rikombinanti (rHuPH20).
English: Anaphylactic shock, anaphylactic/anaphylactoid reaction, tremor, tachycardia, hypotension, flushing, pallor, peripheral coldness, dyspnea, paraesthesia oral, swelling face, dermatitis allergic, musculoskeletal stiffness, injection site urticaria, injection site rash, alanine aminotransferase increased.
Maltese: Xokk anafilattiku, reazzjoni anafilattika/anafilattojdi, rogħda, takikardija, pressjoni baxxa, fwawar, sfurija, kesħa periferali, dispnea, parestesija orali, nefħa tal-wiċċ, dermatite allerġika, ebusija muskoluskeletrali, urtikarja fis-sit tal-injezzjoni, raxx fis-sit tal-injezzjoni, żieda f'alanine aminotransferase.
English: Human normal immunoglobulin vial: 100 mg/ml, at least 98% is IgG Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.
Maltese: Kunjett tal-immunoglobulina umana normali, 100 mg/ml, tal-inqas 98% hija IgG Kontentut massimu ta' immunoglobulina A (IgA): 140 mikrogramma/ml.
English: AUC per week [g*days/l]
Maltese: AUC kull ġimgħa [g*jiem/l]
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 arterjali u tromboemboliċi venużi li jinkludu infart mijokardijaku, aċċessjoni, trombożi tal-vini profondi u emboliżmu pulmonari, ġew assoċjati mal-użu tal-immunoglobulina.
English: Prepare recombinant human hyaluronidase vial (HY):
Maltese: Ipprepara l-kunjett ta' hyaluronidase umana rikombinanti (HY):
English: Efficacy and safety of HyQvia was assessed in a phase 3 study (160603) in 83 patients with PID.
Maltese: L-effikaċja u s-sigurtà tal HyQvia kienu evalwati fi studju tal-fażi 3 (160603) fuq 83 pazjent bil-PID.
English: Thromboembolism
Maltese: Tromboemboliżmu
English: HyQvia contains sodium
Maltese: HyQvia fih is-sodium
English: Common (≥1/100 to <1/10)
Maltese: Komuni (≥1/100 sa <
English: Infuse 2
Maltese: ANNESS II
English: No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults.
Maltese: L-ebda differenzi apprezzabbli fl-effetti farmakodinamiċi jew fl-effikaċja u s-sigurtà ta' HyQvia ma ġew osservati bejn pazjenti pedjatriċi u adulti.
English: One ml of the solution in this vial contains 100 mg of human normal immunoglobulin, of which at least 98% is immunoglobulin G (IgG).
Maltese: ml tas-soluzzjoni f'dan il-kunjett fih 100 mg ta' immunoglobulina umana normali, li għallinqas 98% minnu huwa immunoglobulin G (IgG).
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Maltese: IgG u kumplessi ta' IgG jitkissru fiċ-ċelluli ta-sistema retikuloendoteljali.
English: The recombinant human hyaluronidase facilitates the dispersion and absorption of IG 10%.
Maltese: Hyaluronidase umana rikombinanti tiffaċilita d-dispersjoni u l-assorbiment tal-IG 10%.
English: Interference with serological testing
Maltese: Interferenza ma' ttestjar seroloġiku
English: Immunoglobulin: 100 mg/ml, at least 98% is IgG Maximum immunoglobulin A (IgA) content: 140 micrograms/ml.
Maltese: Proteina umana: 100 mg/ml, tal-inqas 98% hija IgG Kontentut massimu ta' immunoglobulina A (IgA): 140 mikrogramma/ml.
English: HyQvia is a dual vial unit containing: - a solution of recombinant human hyaluronidase (Step 1 of HyQvia/Infuse first) and - a solution of human normal immunoglobulin 10% (Step 2 of HyQvia/Infuse second).
Maltese: HyQvia huwa unità b'żewġ kunjetti li fihom: - soluzzjoni ta' hyaluronidase umana rikombinanti (Pass 1 ta' HyQvia/Agħti bħala l-ewwel infużjoni) u - soluzzjoni ta'immunoglobulina umana normali 10% (Pass 2 ta' HyQvia/Agħti bħala t-tieni infużjoni).
English: Human normal immunoglobulin vial: Glycine, water for injections.
Maltese: Kunjett tal-immunoglobulina umana normali: Glycine, ilma għall-injezzjonijiet.
English: No temporal association between adverse reactions and the presence of anti-rHuPH20 antibodies could be demonstrated.
Maltese: Ma tista' tintwera ebda assoċjazzjoni temporali bejn reazzjonijiet avversi u l-preżenza ta' antikorpi anti-rHuPH20.
English: Immunogenicity of recombinant human hyaluronidase
Maltese: Immunoġeniċità ta' hyaluronidase umana rikombinanti
English: 66 patients who completed the pivotal phase 3 study participated in an extension study (160902) for the evaluation of long-term safety, tolerability and efficacy of HyQvia in PID.
Maltese: 66 pazjent li temmew l-istudju importanti ħafna ta' fażi 3, ipparteċipaw fi studju ta' estensjoni (160902) għall-evalwazzjoni tas-sigurtà, it-tollerabilità u l-effikaċja fit-tul ta' HyQvia f'PID.
English: Results of clinical studies indicate similar safety profiles in adults and paediatric population, including the nature, frequency, seriousness and reversibility of adverse reactions.
Maltese: Ir-riżultati tal-istudji kliniċi jindikaw profili tas-sigurtà simili fl-adulti u fil-popolazzjoni pedjatrika, li jinkludu n-natura, il-frekwenza, is-serjetà u r-riversibilità tar-reazzjonijiet avversi.
English: Adequate doses of human normal immunoglobulin may restore abnormally low IgG levels to the normal range.
Maltese: Dożi adegwati ta' immunoglobulina umana normali jistgħu jreġġgħu livelli abnormalment baxxi ta' IgG għall-firxa normali.
English: Prepare human normal immunoglobulin 10% vial:
Maltese: Agħti l-immunoglobulina umana normali 10%:
English: This medicine contains trace amounts of immunoglobulin A (IgA) (not more than 140 micrograms/ml, 37 micrograms on average).
Maltese: Din il-mediċina fiha traċċi ta' immunoglobulin A (IgA) (mhux aktar minn 140 mikrogramma/ml, 37 mikrogramma bħala medja).
English: • Remove blue protective caps to expose the vial stoppers.
Maltese: • Neħħi t-tappijiet prottettivi blu sabiex tesponi t-tappijiet tal-kunjetti.
English: There is reassuring clinical evidence 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 evidenza klinika inkuraġġanti dwar in-nuqqas ta' trasmissjoni tal-epatite A jew tal-parvovirus B19 permezz tal-immunoglobulini u huwa maħsub ukoll li l-kontenut tal-antikorpi għandu sehem importanti fis-sigurtà virali.
English: Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins.
Maltese: Prodotti li fihom immunoglobulina jkun fihom antikorpi għal gruppi tad-demm (eż. A, B, D) li jistgħu jaġixxu bħala haemolysins.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses.
Maltese: Il-miżuri meħuda huma meqjusin effettivi għal virusijiet enveloped bħall-virus tal-immunodefiċjenza umana (HIV), virus tal-epatite B (HBV) u virus tal-epatite Ċ (HCV) u għall-virus tal-epatite A non-enveloped (HAV) u għall-virus B19 tal-parvovirus.
English: The dosage interval to maintain steady state levels varies from 2-4 weeks.
Maltese: L-intervall tad-dożaġġ biex jinżammu livelli fi stat stabbli jvarja minn 2-4 ġimgħat.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH) Ilma għall-injezzjoni
English: Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected.
Maltese: Esperjenza klinika b'immunoglobulini tissuġġerixxi li ma għandhom ikunu mistennija l-ebda effetti ta' dannu ta' IG 10% fuq il-fertilità.
English: Data from the clinical trials of HyQvia show that serum IgG trough levels can be maintained by dosing regimens of 320 to 1,000 mg/kg body weight/4 weeks given at intervals of 3- or 4-weeks.
Maltese: Dejta minn provi kliniċi ta' HyQvia turi li l-livelli minimi ta' IgG fis-serum jistgħu jinżammu bi skedi ta' dożaġġ ta' 320 sa 1,000 mg/kg piż tal-ġisem/4 ġimgħat li jingħataw f'intervalli ta' 3 jew 4 ġimgħat.
English: Cases of transient aseptic meningitis, transient hemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin, see section 4.4.
Maltese: Każijiet ta' meninġite asettika temporanja, reazzjonijiet emolitiċi temporanji, żieda fil-livell ta' krejatinina fis-serum u/jew insuffiċjenza renali akuta ġew osservati b'immunoglobulina umana normali, ara sezzjoni 4.4.
English: Human normal immunoglobulin
Maltese: Immunoglobulina umana normali
English: The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older.
Maltese: Il-farmakokinetiċi ta' HyQvia ġew evalwati fi studju kliniku f'pazjenti b'PID ta' età minn 12-il sena ‘l fuq.
English: Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis.
Maltese: Persuni li jirċievu prodotti li fihom immunoglobulina għandhom jiġu mmonitorjati għal sinjali kliniċi u għal sintomi ta' emolisi.
English: Hemosiderinuria
Maltese: L-Awstrija
English: Open HyQvia dual vial unit(s):
Maltese: Iftaħ l-unità(jiet) ta' kunjett doppju HyQvia:
English: Items include: dual vial unit(s) of HyQvia, infusion supplies (subcutaneous needle set, solution container (bag or syringe), sterile clear bandage and tape, pump tubing, transfer devices, syringes, gauze and tape), sharps container, pump, and treatment logbook and other supplies as needed.
Maltese: L-oġġetti jinkludu: unità(jiet) ta' kunjett doppju ta' HyQvia, provvisti għall-infużjoni (sett tal-labar għal taħt il-ġilda, kontenitur tas-siringa (borża jew siringa), faxxa trasparenti sterili u tejp, tubi għall-pompa, apparat għat-trasferiment, siringi, garża u tejp), kontenitur ta' affarijiet li jaqtgħu, pompa, u logbook tat-trattament u provvisti oħrajn skont il-bżonn.
English: Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Maltese: L-immunoglobulina umana normali fiha l-antikorpi tal-IgG preżenti fil-popolazzjoni normali.
English: Recombinant human hyaluronidase
Maltese: Hyaluronidase umana rikombinanti
English: The median number of infusion sites per month for HyQvia was 1.09, which is slightly lower than the median number of intravenous IG 10% infusion sites used in this study (1.34), and considerably lower than the median number of infusion sites in the study of subcutaneous administration of IG 10% (21.43).
Maltese: L-għadd medjan ta' siti ta' infużjoni kull xahar għal HyQvia kien ta' 1.09, li huwa ftit inqas mill-għadd medjan ta' siti ta' infużjoni ta' IG 10% ġol-vini użati f'dan l-istudju (1.34), u konsiderevolment aktar baxx mill-għadd medjan ta' siti ta' infużjoni fl-istudju tal-għoti ta' of IG 10% taħt il-ġilda (21.43).
English: AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment.
Maltese: AMS jista' jseħħ b'mod aktar frekwenti b'rabta ma' doża għolja (2 g/kg) ta' kura b'immunoglobulina ġol-vini.
English: The dose of HyQvia was based on the previous treatment with intravenous IG 10% (320 to 1,000 mg/kg body weight /4 weeks) and was individually adapted, ensuring adequate IgG levels throughout the study.
Maltese: Id-doża ta' HyQvia kienet ibbażata fuq il-kura preċedenti b'IG 10% ġol-vini (320 sa 1,000 mg/kg piż tal-ġisem /4 ġimgħat) u kienet individwalment adattata, li żgurat livelli adegwati ta' IgG matul l-istudju.
English: Recombinant human hyaluronidase contains 4.03 mg sodium per ml, with a maximum daily dose of approximately 120 mg.
Maltese: Hyaluronidase umana rikombinanti fiha 4.03 mg ta' sodju kull ml, b'doża massima ta' kuljum ta' madwar 120 mg.
English: It is very important to infuse the medicine at the correct speed.
Maltese: Huwa importanti ħafna li l-mediċina tiġi infuża bir-rata korretta.
English: The other ingredients are sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid (EDTA) disodium, calcium chloride and water for injections (see also section 2, “HyQvia contains sodium”).
Maltese: Is-sustanzi mux attivi l-oħra huma sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid (EDTA) disodium, calcium chloride u ilma għall-injezzjonijiet (ara wkoll is-sezzjoni 2, “HyQvia fih sodium”).
English: The IG 10% component provides the therapeutic effect of this medicinal product.
Maltese: Il-komponent tal-IG 10% jipprovdi l-effett terapewtiku ta' dan il-prodott mediċinali.
English: st
Maltese: C.
English: • If using a pump, prepare the pump to infuse the recombinant human hyaluronidase at an initial rate per infusion site of 60 to 120 ml/hour and increase as tolerated.
Maltese: • Jekk qed tuża pompa, ipprepara l-pompa sabiex tinfuża l- hyaluronidase umana rikombinanti b'rata inizjali għal kull sit ta' infużjoni ta' 60 sa 120 ml/siegħa u żid kif tollerat. 15.
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 għall-Mediċini: http://www.ema.europa.eu
English: The IG 10% component should be infused using a pump.
Maltese: Il-komponent tal-IG 10% irid ikun infuż bl-użu ta' pompa.
English: Seventy eight (78) of 83 (94%) subjects attained the same 3- or 4-week dosing whereas one decreased from 4 to 3 weeks, one from 4 to 2 weeks and one from 3 to 2 weeks (2 subjects withdrew during the titration period).
Maltese: Tmienja u sebgħin (78) minn 83 (94%) individwu kisbu l-istess dożaġġ ta' kull 3 jew 4 ġimgħat filwaqt li wieħed naqas minn 4 għal 3 ġimgħat, wieħed minn 4 ġimgħat għal ġimagħtejn u wieħed minn 3 ġimgħat għal ġimagħtejn (2 individwi rtiraw matul il-perjodu ta' titrazzjoni).
English: (c)
Maltese: (ċ)
English: Severe renal adverse reactions have been reported in patients receiving immunoglobulin intravenous treatment, particularly those products containing sucrose (HyQvia does not contain sucrose).
Maltese: Reazzjonijiet severi tal-kliewi ġew irrappurtati f'pazjenti li jkunu qed jirċievu kura b'immunoglobulina ġol-vini, partikularment dawk il-prodotti li jkun fihom sucrose (HyQvia ma fihx sucrose).
English: Remove needle set:
Maltese: Dawn jinkludu:
English: Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in HyQvia, are protective.
Maltese: L-immunoglobulini ma kinux assoċjati ma' infezzjonijiet tal-epatite A jew tal-parvovirus B19 possibbilment minħabba li l-antikorpi kontra dawn l-infezzjonijiet, li jinsabu f'HyQvia, huma protettivi.
English: Gravitational oedema/genital swelling was observed subsequent to lower abdominal quadrants administration.
Maltese: Edema gravitazzjonali/nefħa ġenitali ġew osservati wara l-għoti fiż-żoni addominali tan-naħa t'isfel.
English: The measures taken for the manufacture of HyQvia 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 meħuda għall-manifattura ta' HyQvia huma meqjusa effettivi għal virusijiet miksija bħall-virus tal-immunodefiċjenza umana (HIV), il-virus tal-epatite B u l-virus tal-epatite Ċ u għall-virus mhux miksi tal-epatite A u l-parvovirus B19.
English: It is supplied as a package containing one vial of human normal immunoglobulin 10% (the active substance) and one vial of recombinant human hyaluronidase (a substance which helps the human normal immunoglobulin 10% reach your blood).
Maltese: Huwa jiġi bħala pakkett li fih kunjett wieħed ta' immunoglobulina umana normali 10% (is-sustanza attiva) u kunjett wieħed ta' hyaluronidase umana rikombinanti (sustanza li tgħin lill-immunoglobulina umana normali 10% tasal fid-demm tiegħek).
English: Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Maltese: Sensittività eċċessiva għal immunoglobulini umani, speċjalment f'każijiet rari ħafna ta' defiċjenza ta' IgA meta l-pazjent jkollu antikorpi kontra
English: HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin SC use only.
Maltese: HyQvia 100 mg/ml infużjoni għal użu taħt il-ġilda immunoglobulina umana normali Użu SC biss.
English: HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin
Maltese: HyQvia 100 mg/ml infużjoni għal użu taħt il-ġilda immunoglobulina umana normali
English: The recommended starting dose is one that supplies 400 to 800 mg of active substance per kg of bodyweight per month.
Maltese: Id-doża tal-bidu rakkomandata hija waħda li tipprovdi 400 sa 800 mg tas-sustanza attiva għal kull kg ta' piż tal-ġisem kull xahar.
English: Hypersensitivity to recombinant human hyaluronidase
Maltese: Sensittività eċċessiva għal hyaluronidase umana rikombinanti
English: One ml contains: Human normal immunoglobulin.
Maltese: Ml wieħed fih: Immunoglobulina umana normali
English: The IG 10% component contains trace amounts of sodium.
Maltese: Il-komponent tal-IG 10% fih traċċi ta' sodju.
English: The recombinant human hyaluronidase of HyQvia acts locally.
Maltese: Il-hyaluronidase umana rikombinanti ta' HyQvia taġixxi lokalment.
English: Record the infusion:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have been rarely observed with IV and SC administration of immunoglobulin products.
Maltese: Reazzjonijiet tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari, u trombożi profonda tal-vini ġew osservati b'mod rari bl-għoti IV u SC ta' prodotti li fihom l-immunoglobulina.
English: • Repeat Step 6, if more than one vial of recombinant human hyaluronidase is needed for your dose.
Maltese: • Irrepeti Pass 6, jekk hemm bżonn ta' aktar minn kunjett wieħed ta' hyaluronidase umana rikombinanti għad-doża tiegħek.
English: HyQvia.
Maltese: Tilqim
English: Infusion site discoloration, infusion site bruising (including hematoma, haemorrhage), infusion site mass (including nodule), infusion site warmth, infusion site induration, gravitational oedema/genital swelling b (including genital oedema, scrotal and, vulvovaginal swelling)
Maltese: tal-infużjoni (li jinkludi ematoma, emorraġija), massa fis-sit tal-infużjoni (li tinkludi għoqiedi), sħana fis-sit tal-infużjoni, ebusija fis-sit tal-infużjoni, edema gravitazzjonali/nefħa ġenitali b
English: Abdominal distension
Maltese: Disturbi vaskulari
English: Renal and urinary disorders
Maltese: Insuffiċjenza renali akuta
English: • Remove the peel-off label from HyQvia vial, which has the product lot number and expiration date, and place the label in your treatment record/log book.
Maltese: • Neħħi t-tikketta li tinqala' minn mal-kunjett ta' HyQvia, li għandha fuqha n-numru tal-lott tal-prodott u d-data ta' skedenza, u poġġi t-tikketta fir-rekord/logbook tat-trattament tiegħek.
English: Spread of localised infections
Maltese: Firxa ta' infezzjonijiet lokalizzati
English: Human normal immunoglobulin (IG 10%) vial Glycine
Maltese: Kunjett tal-immunoglobulina umana normali (IG 10%)
English: Known systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase.
Maltese: Sensittività eċċessiva sistemika magħrufa għal hyaluronidase jew għal hyaluronidase umana rikombinanti.