FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic Parameters of HyQvia Compared to Intravenous Administration of IG 10% Parameter
Maltese: Parametri farmakokinetiċi ta' HyQvia mqabbla ma' għoti għal ġol-vini ta' IG 10% Parametru
English: You are at increased risk of allergic reactions if you have IgA deficiency with anti-IgA antibodies.
Maltese: Ikollok riskju akbar ta' reazzjonijiet allerġiċi jekk ikollok defiċjenza tal-IgA b'antikorpi kontra l-IgA.
English: • If possible, combine all of the recombinant human hyaluronidase needed for the entire dose of IgG into the same syringe.
Maltese: • Jekk possibbli, ikkombina hyaluronidase umana rikombinanti kollha meħtieġa għad-doża sħiħa ta' IgG għal ġos-siringa.
English: Patients with anti-IgA antibodies, in whom treatment with subcutaneous IgG products remains the only option, should be treated with HyQvia only under close medical supervision.
Maltese: Pazjenti b'antikorpi anti-IgA, li fihom il-kura bi prodotti IgG li jingħataw taħt il-ġilda tibqa' l-unika għażla, għandhom jiġu kkurati b'HyQvia taħt superviżjoni medika stretta biss.
English: No adverse effects on fertility were observed in mice, rabbits and cynomolgus monkeys exposed to antibodies that bind to recombinant human hyaluronidase and species-specific hyaluronidase.
Maltese: L-ebda effetti avversi fuq il-fertilità ma ġew osservati fil-ġrieden, fniek u xadini cynomolgus esposti għal antikorpi li jeħlu ma' hyaluronidase umana rikombinanti u hyaluronidase speċifika.
English: Side effects seen with similar medicines
Maltese: Effetti sekondarji li dehru b'mediċini simili
English: • Allow vials to reach room temperature.
Maltese: • Ħalli l-kunjetti sakemm jiġu għal temperatura ambjentali.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Patients naïve to immunoglobulin therapy
Maltese: Pazjenti li qatt ma rċevew terapija b'immunoglobulina
English: These antibodies bind to red blood cells (RBC) epitops (which may be detected as a positive direct antiglobulin test [DAT, (Coombs' test)] and, rarely, may cause haemolysis.
Maltese: Dawn l-antikorpi jeħlu maċ-ċelluli tad-demm ħomor (RBC) epitops (li jistgħu jiġu osservati bħala test ta' antiglobulina pożittiva diretta [DAT, (test ta' Coombs)]) u, rarament, jistgħu jikkawżaw emolisi.
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 umana normali tista' tinduċi tnaqqis fil-pressjoni tad-demm b'reazzjoni anafilattika, anki f'pazjenti li kienu ttolleraw kura preċedenti b'immunoglobulina umana normali.
English: Infusion speed
Maltese: Rata tal-infużjoni
English: How to store HyQvia
Maltese: Kif jaħdem HyQvia
English: You may be allergic to immunoglobulins without knowing it. Allergic reactions such as sudden fall in blood pressure or anaphylactic shock (a sharp fall in blood pressure with other symptoms such as swelling of the throat, breathing difficulties and skin rash) are rare but they can occasionally occur even if you have not previously had problems with similar treatments.
Maltese: Reazzjonijiet allerġiċi bħal waqgħa f'daqqa fil-pressjoni tad-demm jew xokk anafilattiku (il-pressjoni tad-demm tinżel f'daqqa b'sintomi oħrajn bħal pereżempju nefħa fil-griżmejn, diffikultajiet fit-teħid tan-nifs u raxx fuq il-ġilda) huma rari iżda jistgħu kultant iseħħu anki jekk qabel ma kellekx problemi bi trattamenti simili.
English: The most frequent adverse reactions reported during post-marketing use of recombinant human hyaluronidase in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain.
Maltese: L-aktar reazzjonijiet avversi frekwenti rrapportati matul l-użu ta' hyaluronidase umana rikombinanti wara t-tqegħid fis-suq f'formulazzjonijiet simili mogħtija taħt il-ġilda għad-dispersjoni u l-assorbiment ta' fluwidi jew prodotti mediċinali mogħtija taħt il-ġilda kienu reazzjonijiet ħfief lokali fis-sit tal-infużjoni bħal eritema u uġigħ.
English: • Check each vial of HyQvia before using:
Maltese: • Iċċekkja kull kunjett ta' HyQvia qabel tuża:
English: • Patients should be informed of the early signs of anaphylaxis/hypersensitivity (hives, pruritus, generalized urticaria, tightness of the chest, wheezing, and hypotension).
Maltese: • Il-pazjenti għandhom jiġu infurmati bis-sinjali bikrija ta' anafilassi / sensittività eċċessiva (ħorriqija, ħakk, urtikarja ġeneralizzata, tagħfis fis-sider, tħarħir, u pressjoni baxxa).
English: The human normal immunoglobulin 10% of HyQvia and human serum albumin (an ingredient of the recombinant human hyaluronidase) are made from human plasma (the liquid part of blood).
Maltese: L-immunoglobulina umana normali 10% ta' HyQvia u l-albumina tas-serum uman (ingredjent tal-hyaluronidase umana rikombinanti) isiru mill-plażma umana (il-parti likwida tad-demm).
English: • Prepare to transfer the immunoglobulin 10% component of HyQvia by wiping each vial stopper with an alcohol swab, if directed and allow to air dry (at least 30 seconds).
Maltese: • Ipprepara biex tittrasferixxi l-komponent tal-immunoglobulina 10% ta' HyQvia billi timsaħ kull tap ta' kunjett bi swab bl-alkoħol, jekk tingħata parir li tagħmel hekk, u tħallih jinxef fl-arja (mill-inqas 30 sekonda).
English: • patients with a specific cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections who have failed to respond to a vaccine against certain bacteria (pneumococci).
Maltese: • pazjenti b'kanċer speċifiku tal-mudullun (majeloma multipla) u nuqqas ta' produzzjoni ta' antikorpi b'infezzjonijiet rikorrenti li ma rrispondewx għal tilqima kontra ċerti batterji (pnewmokokki).
English: No adverse effects on pregnancy and foetal development were associated with anti-rHuPH20 antibodies.
Maltese: L-ebda effetti avversi fuq it-tqala u l-iżvilupp tal-fetu ma ġew assoċjati ma' antikorpi anti-rHuPH20.
English: • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
Maltese: • Ipogammaglobulinemija u infezzjonijiet batterjali rikorrenti f'pazjenti b'lewkimja limfoċitika kronika (CLL), li fihom antibijotiċi profilattiċi ma jkunux irnexxew jew huma kontraindikati.
English: Use aseptic technique when preparing and administering HyQvia.
Maltese: Uża teknika asettika meta tipprepara u tagħti HyQvia.
English: Animal studies do not indicate direct or indirect harmful effects of recombinant human hyaluronidase with respect to reproductive potential at the doses used for facilitating administration of IG 10% (see section 5.3).
Maltese: Studji fuq l-annimali ma jindikaw l-ebda effett ta' dannu diretti jew indiretti ta' hyaluronidase uman rikombinanti fir-rigward ta' potenzjal riproduttiv fid-dożi wżati biex jiffaċilitaw l-għoti ta' IG 10% (ara sezzjoni 5.3).
English: • Sodium (as chloride and as phosphate) The total sodium content of recombinant human hyaluronidase is 4.03 mg/ml.
Maltese: Il-kontenut totali ta' sodju ta' hyaluronidase umana rikombinanti huwa ta' 4.03 mg/ml.
English: The most frequently reported adverse reactions (ARs) of HyQvia were local reactions.
Maltese: L-aktar reazzjonijiet avversi (ARs) frekwenti rrapportati ta' HyQvia kienu reazzjonijiet lokali.
English: What HyQvia is
Maltese: Mekkaniżmu ta' azzjoni
English: HyQvia is prescribed as replacement therapy to patients who do not have sufficient antibodies, including the following groups:
Maltese: HyQvia jingħata bħala terapija ta' sostituzzjoni lil pazjenti li m'għandhomx antikorpi suffiċjenti, li jinkludu l-gruppi li ġejjin:
English: • Rotate infusion sites by choosing opposite sides of the body between future infusions.
Maltese: • Ibdel is-siti ta' infużjoni billi tagħżel naħat opposti tal-ġisem bejn infużjonijiet futuri.
English: • The human normal immunoglobulin 10% of HyQvia may be infused either o by pooling from the vials either into larger syringe (a) or an infusion bag (b) as directed by your healthcare professional, depending upon the pump to be used; or o directly from the IG vial (c).
Maltese: • L-immunoglobulina umana normali 10% ta' HyQvia tista' tingħata b'infużjoni jew o billi tinġabar mill-kunjetti jew għal ġewwa s-siringa l-kbira (a) jew borża għall-infużjoni (b) skont kif qallek il-professjonista tal-kura tas-saħa tiegħek, skont il-pompa li sejra tintuża; jew o direttament mill-kunjett tal-IG (ċ).
English: Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days.
Maltese: B'differenza mill-komponenti strutturali stabbli tal-matriċi interstizjali, hyaluronan għandu moviment mgħaġġel ħafna f'tessut taħt il-ġilda b'half-life ta' madwar 0.5 jiem.
English: The effects of antibodies that bind to recombinant human hyaluronidase on human fertility are unknown.
Maltese: L-effetti tal-antikorpi li jeħlu ma' hyaluronidase umana rikombinanti fuq il-fertilità umana mhumiex magħrufa.
English: In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response.
Maltese: Fit-terapija ta' sostituzzjoni, jista' jkun hemm bżonn li d-doża tiġi individwalizzata għal kull pazjent skont ir-rispons farmakokinetiku u kliniku.
English: IG 10% is a clear or slightly opalescent and colourless or pale yellow solution.
Maltese: IG 10% hija soluzzjoni trasparenti jew ftit opaka u bla kulur jew safra ċara.
English: • Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.
Maltese: • Ipogammaglobulinemija u infezzjonijiet batterjali rikorrenti f'pazjenti b'majeloma multipla (MM).
English: Reversible infertility has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase.
Maltese: Ir-riversibblita tal-infertilità ġiet osservata fi fniek tal-Indi rġiel u nisa li kienu mlaqqma sabiex jipproduċu antikorpi għal hyaluronidase.
English: Remove HyQvia from the box:
Maltese: Neħħi HyQvia mill-kaxxa:
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti kollha jkunu fis-suq.
English: During the infusion you must look out for first signs of side effects (for further details see section 4, “Possible side effects”).
Maltese: Waqt l-infużjoni trid toqgħod attent għall-ewwel sinjali ta' effetti sekondarji (għal aktar dettalji ara sezzjoni 4, “Effetti sekondarji possibbli”).
English: The dose required to achieve a trough level of 6 g/l is of the order of 0.4-0.8 g/kg body weight per month.
Maltese: Id-doża meħtieġa biex jintlaħaq livell minimu ta' 6 g/l hija fl-ordni ta' 0.4-0.8 g/kg ta piż tal-ġisem kull xahar.
English: The following rare side effects have been observed in patients using medicines like human normal immunoglobulin 10% given into a vein (intravenously).
Maltese: Dawn l-effetti sekondarji rari ġew osservati f'pazjenti li jużaw mediċini bħal immunoglobulina umana normali 10% mogħtija f'vina (ġol-vina).
English: The human normal immunoglobulin 10% is a clear and colourless or pale yellow solution.
Maltese: Immunoglobulina umana normali 10% hija soluzzjoni ċara u bla kulur jew safra ċara.
English: Development of non-neutralizing antibodies to the recombinant human hyaluronidase component has been reported in patients receiving HyQvia in clinical studies.
Maltese: Żvilupp ta' antikorpi mhux newtralizzanti għall-komponent ta' hyaluronidase umana rikombinanti ġie rrappurtat f'pazjenti li kienu qed jirċievu HyQvia fl-istudji kliniċi.
English: The following side effects have been observed with infusion of medicines like human normal immunoglobulin 10% given under the skin (subcutaneously).
Maltese: L-effetti sekondarji li ġejjin ġew osservati b'infużjoni ta' mediċini bħal immunoglobulina umana normali 10% mogħtija taħt il-ġilda (subkutanea).
English: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and - the testing of each donation and pools of plasma for signs of viruses/infections.
Maltese: - l-għażla attenta tad-donaturi tad-demm u tal-plażma sabiex ikun assigurat li dawk f'riskju li jġorru infezzjonijiet ikunu esklużi, u - l-ittestjar ta' kull donazzjoni u gruppi ta' plażma għal sinjali ta' virus/infezzjonijiet.
English: Migraine dizziness
Maltese: Reazzjonijiet allerġiċi
English: Infuse first the recombinant human hyaluronidase.
Maltese: L-ewwel infuża hyaluronidase umana rikombinati.
English: Pack size: One vial of IG 10% and one vial of recombinant human hyaluronidase in a dual vial unit.
Maltese: Kunjett wieħed ta' IG 10% u kunjett wieħed ta' hyaluronidase umana rikombinanti f'unità ta' kunjetti doppji.
English: Firmly grasp and pinch at least 2 to 2.5 cm of skin between two fingers.
Maltese: B'mod sod aqbad u oqros mill-inqas 2 sa 2.5 ċm ta' ġilda bejn żewġ swaba'.
English: Prepare the infusion site:
Maltese: Reazzjonijiet lokali:
English: Caution should be exercised in patients with pre-existing risk factors for thromboembolic 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 kawtela f'pazjenti b'fatturi ta' riskju li kienu jeżistu qabel għal avvenimenti tromboemboliċi (bħal età avvanzata, pressjoni għolja, dijabete mellitus u storja ta' mard vaskulari jew episodji trombotiċi, pazjenti b'disturbi trombofiliċi akkwiżiti jew li ntirtu, pazjenti b'perjodi twal ta' immobilizzazzjoni, pazjenti severament ipovolemiċi, pazjenti b'mard li jżid il-viskożità tad-demm).
English: The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm.
Maltese: Jeżisti l-potenzjal li dawn l-antikorpi li jirreaġixxu b'mod inkroċjat ma' PH20 endoġenu, li hu magħruf li jiġi espress fit-testikoli, l-epididimis, u fl-isperma ta' adulti rġiel.
English: Oedema (including peripheral, swelling), chills, hyperhidrosis
Maltese: Edema (li tinkludi edema periferali, nefħa), tertir ta' bard, iperidrożi
English: The expiry date refers to the last day of that month.
Maltese: Tużax wara d-data ta' skadenza.
English: HyQvia 100 mg/ml solution for infusion for subcutaneous use
Maltese: HyQvia 100 mg/ml soluzzjoni għal infużjoni għal użu taħt il-ġilda
English: Immune system disorders: Hypersensitivity General disorders and administration site conditions: Influenza-like illness, infusion site leakage
Maltese: Meninġite asettika Disturbi fis-sistema immuni: Sensittività eċċessiva Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: • Insert needle completely to the wings of the needle with a rapid motion straight into the skin at a 90-degree angle.
Maltese: • Daħħal il-labra kompletament sal-ġwienaħ tal-labra b'moviment dritt u veloċi għal ġewwa l-ġilda f'angolu ta' 90 grad.
English: Pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise)
Maltese: Deni, kundizzjonijiet asteniċi (li jinkludu astenja, għeja, letarġija, telqa)
English: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella.
Maltese: L-għoti tal-immunoglobulina tista' tfixkel għal perjodu ta' mill-anqas 6 ġimgħat u sa 3 xhur l-effikaċja ta' tilqim b'virus ħaj attenwat bħall-ħosba, ir-rubella, il-gattone u l-ġidri r-riħ.
English: • Withdraw the full contents of the recombinant human hyaluronidase into the syringe.
Maltese: • Iġbed il-kontenut kollu tal-hyaluronidase uman rikombinanati għal ġos-siringa.
English: Recombinant human hyaluronidase is a soluble recombinant form of human hyaluronidase that increases the permeability of the subcutaneous tissue by temporarily depolymerizing hyaluronan.
Maltese: Hyaluronidase umana rikombinanti hija forma rikombinanti solubbli ta' hyaluronidase umana li żżid il-permeabilità tat-tessut taħt il-ġilda billi temporanjament tagħmel depolymerization ta' hyaluronan.
English: • patients with a certain kind of blood cancer (chronic lymphocytic leukaemia) which leads to a lack of antibody production and recurrent infections when preventative antibiotics have failed.
Maltese: • pazjenti b'kanċer tal-demm (lewkimja limfoċitika kronika) li twassal għal nuqqas ta' produzzjoni ta' antikorpi u infezzjonijiet rikorrenti meta antibijotiċi preventivi ma jkunux irnexxew.
English: Chills,migraine, increasedblood pressure, dizziness, abdominal bloating, skin rash/allergic rash/redness, itching, pain in chest, arms and/or legs, genital swelling (resulting from spread of swelling from the infusion site), swelling of the legs, feet and ankles, positive blood tests for antibodies.
Maltese: Tertir ta' bard, emigranja, pressjoni tad-demm ogħla, sturdament, nefħa fiż-żaqq, raxx/raxx allerġiku/ħmura tal-ġilda, ħakk, uġigħ fis-sider, fid-dirgħajn u/jew fir-riġlejn, nefħa ġenitali (li tirriżulta mill-firxa tan-nefħa mis-sit tal-infużjoni), nefħa tar-riġlejn, tas-saqajn u tal-għekiesi, testijiet tad-demm pożittivi għall-antikorpi.
English: Vomiting, nausea, abdominal pain (including abdominal upper and lower pain and tenderness), diarrhoea
Maltese: Rimettar, nawseja, uġigħ addominali (inkluż uġigħ fil-parti ta' fuq u t'isfel tal-addome, u sensittività), dijarea
English: The following infusion rates of the IG 10% are recommended per infusion site:
Maltese: Ir-rati li ġejjin ta' infużjoni tal-IG 10% huma rakkomandati għal kull sit tal-infużjoni:
English: 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: Miżuri standard biex jipprevjenu infezzjonijiet bħala riżultat tal-użu ta' prodotti mediċinali ppreparati minn demm jew plasma umana jinkludu l-għażla tad-donaturi, l-iscreening ta' donazzjonijiet individwali u ta' pools tal-plasma għal markaturi speċifiċi ta' infezzjoni u l-inklużjoni ta' miżuri effettivi fil-manifattura għall-inattivazzjoni/tneħħija tal-viruses.
English: Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Maltese: Għandu jkun hemm monitoraġġ għal sinjali u sintomi ta' trombożi u evalwazzjoni tal-viskożità tad-demm f'pazjenti f'riskju ta' iperviskożità.
English: - Keep this leaflet.
Maltese: Agħti t-tieni permezz ta' infużjoni.
English: - feeling light-headed, dizzy or faint, - skin rash and itchiness, swelling in the mouth or throat, difficulty breathing, wheezing, - abnormal heart rate, chest pain, blueness of lips or fingers and toes, - blurred vision.
Maltese: - tħossok stordut jew b'ħass ħażin, - raxx fil-ġilda u ħakk, nefħa fil-ħalq jew fil-griżmejn, diffikultà biex tieħu n-nifs, tħarħir, - rata tal-qalb mhux normali, uġigħ fis-sider, lewn ikħal fix-xofftejn, is-swaba' tal-idejn jew tas-saqajn, - vista mċajpra.
English: Apparent clearance or clearance [ml/kg/day] 1.6 (1.4 to 1.79)
Maltese: Eliminazzjoni apparenti jew eliminazzjoni [ml/kg/jum]
English: Immunoglobulins are normal constituents of the human body.
Maltese: 1 kunjett immunoglobulina normali umana
English: Effects on blood tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: HyQvia has to be infused under the skin (subcutaneous or SC administration).
Maltese: HyQvia għandu jiġi infuż taħt il-ġilda (għoti subkutanju jew SC).
English: Infuse the full dose per site of IG 10% through the same subcutaneous needle set within 10 minutes of the recombinant human hyaluronidase.
Maltese: Kull kunjett ta' IG 10% hu fornut bil-kwantità adattata li tikkorrispondi għall-kwantità ta' hyaluronidase umana rikombinanti kif iddikjarat fit-tabella ta' hawn taħt.
English: This may occur if you have IgA deficiency.
Maltese: Dan jista' jseħħ jekk għandek defiċjenza ta' IgA.
English: Local reactions at infusion sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash, may frequently occur.
Maltese: Reazzjonijiet lokali fis-siti tal-infużjoni: nefħa, uġigħ, ħmura, ebusija, sħana lokali, ħakk, tbenġil u raxx, jistgħu jseħħu b'mod frekwenti.
English: There are currently no clinical safety data for HyQvia on fertility available.
Maltese: Fil-preżent, b'HyQvia ma kien hemm ebda dejta tas-sigurtà klinika disponibbli dwar l-iżvilupp tas-sistema riproduttiva,
English: nd
Maltese: b
English: • Prepare to transfer the recombinant human hyaluronidase component of HyQvia by wiping each vial stopper with an alcohol swab, if directed and allow to air dry (at least 30 seconds).
Maltese: • Ipprepara biex tittrasferixxi l-komponent ta' hyaluronidase uman rikombinanti ta' HyQvia billi timsaħ kull tap ta' kunjett bi swab bl-alkoħol, jekk tingħata parir li tagħmel hekk, u tħallih jinxef fl-arja (mill-inqas 30 sekonda).
English: This vial contains recombinant human hyaluronidase.
Maltese: Agħti l-infużjoni ta' hyaluronidase umana rikombinanti:
English: Arthralgia, back pain, pain in extremity
Maltese: Artralġja, uġigħ fid-dahar, uġigħ fl-estremitajiet
English: ► Tell your doctor about your treatment with HyQvia before any blood test.
Maltese: Ipprepara żona ta' xogħol nadifa.
English: Infusion site pain (including discomfort, tenderness, groin pain)
Maltese: Rari (≥1/10,000 sa tal-infużjoni (li jinkludi skumdità, sensittività, uġigħ fil-groin)
English: Since HyQvia contains trace amounts of IgA, you might have an allergic reaction.
Maltese: Billi HyQvia fih ammonti traċċa ta' IgA, jista' jkollok reazzjoni allerġika.
English: VIAL LABEL RECOMBINANT HUMAN HYALURONIDASE (2.5 ML, 5 ML, 10 ML, 15 ML)
Maltese: ML, 10 ML, 15 ML)
English: The following pack sizes are available:
Maltese: Id-daqsijiet tal-pakkett li ġejjin huma disponibbli:
English: ► Please tell your vaccinating doctor or nurse about your treatment with HyQvia.
Maltese: • Dan il-prodott mediċinali jikkonsisti minn żewġ kunjetti.
English: For the 1.25 mL recombinant human hyaluronidase vial size use a 18-22 gauge needle to withdraw the contents of the vial to prevent stopper push through or coring; for all other vial sizes a needle or needle-less device may be used to withdraw the contents of the vial.
Maltese: Għad-daqs tal-kunjett ta' 1.25 ml hyaluronidase umana rikombinanti, uża labra b'daqs ta' 18-22 gauge biex tiġbed il-kontenut tal-kunjett biex tipprevjeni push-through jew coring tat-tapp; għad-daqsijiet tal-kunjetti l-oħrajn kollha, labra jew tagħmir mingħajr labra jistgħu jintużaw biex tiġbed il-kontenut tal-kunjett.
English: Gather all supplies: Collect all items for your infusion.
Maltese: Ara l-istampa għal siti ta' postijiet għall-infużjoni.
English: HyQvia administration scheme Recombinant human hyaluronidase
Maltese: Infużjoni għal użu taħt il-ġilda għal HyQvia hyaluronidase
English: Patients were treated with HyQvia at either 3- or 4-week treatment intervals for a total of 12 months (following a brief titration period).
Maltese: Il-pazjenti rċevew kura bi HyQvia f'intervalli ta' kura jew ta' 3- jew ta' 4 ġimgħat għal total ta' 12-il xahar (wara perjodu qasir ta' titrazzjoni).
English: MA (EU) Number
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: Pack size
Maltese: UI
English: Route of Administration
Maltese: Trab: 500