FrancophonIA/ELRC3.0 huggingface dataset:
English: • Thromboembolic reactions such as myocardial infarction (tight band around the chest with feeling like your heart is beating too fast), stroke (muscle weakness in the face, arm, or leg, trouble speaking or understanding others who are speaking), pulmonary embolism (shortness of breath, chest pain and fatigue), deep vein thromboses (pain and swelling in an extremity).
Maltese: • Reazzjonijiet tromboemboliċi bħal infart mijokardijaku (tħoss qisha ċinga ssikkata madwar sidrek u tħoss qalbet tħabbat tgħaġġel ħafna), puplesija (dgħufija fil-muskoli fil-wiċċ, dirgħajn, jew riġlejn, problemi biex titkellem jew tifhem lil persuni oħrajn li jkunu qed jitkellmu), emboliżmu pulmonari (qtugħ ta' nifs, uġigħ fis-sider u għeja kbira), trombożi tal-vini profondi (uġigħ u/jew nefħa f'xi estremità tal-ġisem).
English: If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min.
Maltese: tiżdied gradwalment sa massimu ta' 0.1 ml/kg/min.
English: Back pain, Myalgia
Maltese: Uġigħ fid-dahar, Mijalġja
English: ● general physical health deterioration
Maltese: • deterjorament ġenerali fis-saħħa fiżika
English: ● haematoma
Maltese: ● ematoma
English: • 0.8 - 1 g/kg given on day one; this dose may be repeated once within 3 days.
Maltese: 0.8 - 1 g/kg f'jum 1, possibilment ripetuta fi żmien 3 ijiem
English: Cyanosis
Maltese: Anzjani
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 - 0.02 ml/kg/min).
Maltese: Fil-bidu ta' l-infużjoni tiegħek, inti ser tirċievi Flebogamma DIF b'rata bil-mod (0.01-0.02 ml/kg/min).
English: Immunomodulation: Primary immune thrombocytopenia
Maltese: Tromboċitopenija immuni primarja
English: ● abdominal pain (including abdominal pain upper)
Maltese: ● mejt ● ipertensjoni (pressjoni tad-demm għolja)
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 100 mg/ml solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Flebogamma DIF 100 mg/ml soluzzjoni għall-infużjoni
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Millilitru wieħed fih 50 mg ta' immunoglobulina umana normali (IVIg), li minnu, mill-anqas 97% hu IgG.
English: Grifols Polska Sp. z o. o. Tel: +48 22 378 85 60
Maltese: Tel: +48 22 378 85 60
English: Interferences with determination of blood glucose levels are not expected.
Maltese: Interferenzi bid-determinazzjoni tal-livelli tal-glucose fid-demm mhumiex mistennija.
English: • pruritus (itching)
Maltese: • fwawar (tiħmar)
English: LIST OF EXCIPIENTS D-sorbitol, water for injections.
Maltese: D-sorbitol, ilma għall-injezzjonijiet.
English: ● diarrhoea
Maltese: ● dijarea
English: Maintenance dose: 1 g/kg or 2 g/kg in divided doses over 2 - 5 consecutive days every 2 - 4 weeks every 4 - 8 weeks in divided doses over 2 - 5 days
Maltese: manteniment: 1 g/kg jew 2 g/kg f'dożi maqsuma fuq 2 - 5 ijiem konsekuttivi kull ġimagħtejn - 4 ġimgħat kull 4 - 8 ġimgħat f'dożi maqsuma fuq 2 - 5 ijiem
English: This medicine contains 50 mg of sorbitol per ml.
Maltese: Din il-mediċina fiha 50 mg ta' sorbitol f'kull 1 ml.
English: Do not use Flebogamma DIF
Maltese: Tużax Flebogamma DIF
English: In case of renal impairment, IVIg discontinuation should be considered.
Maltese: F'każ ta' indeboliment renali, għandu jiġi kkunsidrat it-twaqqif ta' IVIg.
English: Rare (may affect up to 1 in 1000 infusions):
Maltese: Rari (jistgħi jaffettwaw sa 1 minn kull 1000 infużjoni):
English: A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/µl) although it did not reach normal levels.
Maltese: Żieda sinifikanti fil-medjan tal-livelli tal-plejtlits intlaħqet fi prova klinika f'pazjenti b'ITP kronika (64,000/µl), għalkemm ma laħqux il-livelli normali.
English: Other medicines and Flebogamma DIF
Maltese: Mediċini oħra u Flebogamma DIF
English: The absence of mortality in the non-clinical studies performed with Flebogamma DIF with doses up to 2500 mg/kg, and the lack of any confirmed relevant adverse sign affecting respiratory, circulatory and central nervous system of the treated animals support the safety of Flebogamma DIF.
Maltese: L-assenza ta' mortalità fl-istudji mhux kliniċi li saru bil-Flebogamma DIF b'dożi sa 2500 mg/kg, u n-nuqqas ta' kwalunkwe sinjal avvers rilevanti kkonfermat li jaffettwa s-sistema respiratorja, ċirkolatorja u s-sistema nervuża ċentrali fl annimali kkurati, jissapportja s-sigurtà ta' Flebogamma DIF.
English: The dose required to achieve a trough level of IgG of 6 g/l is of the order of 0.2 - 0.8 g/kg/month.
Maltese: Id-doża meħtieġa biex jintlaħaq livell minimu ta' IgG ta' 6 g/l hi ta' 0.2 - 0.8 g/kg/xahar.
English: ● acne
Maltese: ● dardir
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Flebogamma DIF 50 mg/ml soluzzjoni għall-infużjoni
English: Epistaxis, Nasal congestion, Upper-airway cough syndrome, Sinus pain, Dyspnoea
Maltese: Epistassi, Skonfort fl-imnieħer,
English: Kawasaki disease
Maltese: toraċiċi u medjastinali
English: Uncommon (may affect up to 1 in 100 infusions):
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 infużjonijiet):
English: • Cases of transfusion related acute lung injury (TRALI) that causes hypoxia (lack of oxygen), dyspnoea (difficulty in breathing), tachypnoea (rapid breathing), cyanosis (lack of oxygen in the blood), fever and hypotension.
Maltese: • Każijiet ta' leżjoni akuta fil-pulmun relatata mat-trasfużjoni (TRALI) li tikkawża ipossija (nuqqas ta' ossiġnu), qtugħ ta' nifs (diffikultà biex tieħu n-nifs), takipnea (nifs mgħaġġel), ċijanożi
English: Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Maltese: Flebogamma DIF 50 mg/ml soluzzjoni għall-infużjoni
English: Ear and labyrinth disorders Vertigo
Maltese: Disturbi fil-widnejn u fissistema labirintika
English: Starting dose: 2 g/kg divided over 2 - 5 consecutive days.
Maltese: 2 g/kg maqsuma fuq 2 - 5 ijiem konsekuttivi.
English: One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Maltese: Millilitru wieħed fih 50 mg ta' immunoglobulina umana normali(IVIg), li minnu, mill-anqas 97% hu IgG.
English: Headache
Maltese: Doża
English: Cardiovascular disorder
Maltese: Disturbi respiratorji,
English: Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl. AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
Maltese: spiss pożittivi bi plewċitosi sa diversi eluf ta' ċelluli kull mm3, il-biċċa l-kbira mis-serje granuloċitika, u livelli għolja ta' proteina sa diversi mijiet ta' mg/dl.
English: Three clinical trials were performed with Flebogamma DIF, one for replacement therapy in patients with primary immunodeficiency (in both adults and in children above 6 years) and two for immunomodulation, in patients with immune thrombocytopenic purpura (one in adult patients and another in both adults and in children between 3 and 16 years).
Maltese: Tliet provi kliniċi twettqu bil-Flebogamma DIF, waħda għat-terapija ta' sostituzzjoni f'pazjenti b'immunodefiċjenza primarja (kemm f'adulti u fi tfal ta' aktar minn 6 snin), u tnejn għallimmunomodulazzjoni f'pazjenti b'purpura tromboċitopenika immuni (waħda f'pazjenti adulti u oħra kemm f'adulti u fi tfal ta' bejn 3 u 16-il sena).
English: It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma.
Maltese: Għandha distribuzzjoni ta' sottoklassijiet ta' immunoglobulina G li tixbah proporzjonalment lil dik li tinsab b'mod naturali fil-plażma umana.
English: • neck pain
Maltese: Dawn jinkludu:
English: One ml contains 100 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Maltese: Millilitru wieħed fih 100 mg ta' immunoglobulina umana normali (IVIg), li minnu, mill-anqas 97% hu IgG.
English: ● arthralgia (joint pain)
Maltese: • astenja (għeja)
English: In patients receiving IVIg, there have been some reports of acute non-cardiogenic pulmonary oedema [Transfusion Related Acute Lung Injury (TRALI)].
Maltese: F'pazjenti li kienu qed jirċievu IVIg, kien hemm xi rapporti ta' edema pulmonari mhux kardijoġenika akuta [Leżjoni Akuta fil-Pulmun Relatata mat-Trasfużjoni (TRALI)].
English: Pyrexia, Rigors
Maltese: FULJETT TA' TAGĦRIF
English: • A sudden fall in blood pressure and, in isolated cases, anaphylactic shock (which signs are rash, hypotension, palpitation, wheezing, coughing, sneezing and difficulty breathing among others), even if you have shown no hypersensitivity to previous administration.
Maltese: • Tnaqqis għal għarrieda fil-pressjoni tad-demm u, f'każijiet iżolati, xokk anafilattiku (li s-sinjali tiegħu huma raxx, pressjoni baxxa, palpitazzjonijiet, tħarħir, sogħla, għatis u diffikultà biex tieħu n-nifs, fost oħrajn), anki jekk ma kellek l-ebda sensittività eċċessiva meta tkun ingħatajt il mediċina fil-passat.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: * PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Maltese: *PSAF= meta wieħed ma jirnexxilux ikollu mill-inqas żieda ta' darbtejn fit-titre tal-antikorpi għal vaċċini pnewmokokkali tal-antiġen tal-polysaccharide u tal-polypeptide
English: 0.4 g/kg/d for 5 days
Maltese: 0.4 g/kg/kuljum għal 5 ijiem
English: Uncommon Uncommon
Maltese: Komuni Ħafna Komuni
English: ● chest discomfort/chest pain
Maltese: ● skonfort u nefħa fiż-żaqq
English: A Post-Authorisation Safety Study suggested a higher rate of infusions associated with potentially related adverse events for Flebogamma DIF 100 mg/ml compared to Flebogamma DIF 50 mg/ml (see section 5.1).
Maltese: Studju dwar is-Sigurtà Wara l-Awtorizzazzjoni ssuġġerixxa rata ogħla ta' infużjonijiet assoċjati ma' avvenimenti avversi potenzjalment relatati għal Flebogamma DIF 100 mg/ml meta mqabbla ma'
English: If well tolerated, advance to 0.02 ml/kg/min for the second 30 minutes.
Maltese: Jekk tkun ittollerata, żid id-doża għal 0.02 ml/kg/min għat-tieni 30 minuta.
English: Patients with a kidney problem
Maltese: Pazjenti bi problemi tal-kliewi
English: Pruritus, Rash pruritic
Maltese: OĦRAJN Biex iddendel, iġbed hawnhekk
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Maltese: • l-eżaminazzjoni ta' kull għotja u ta' pools ta' plażma għal sinjali ta' virus/infezzjonijiet,
English: ● thrombosis
Maltese: ● trombożi
English: The recommended infusion rate given under section 4.2 must be closely followed.
Maltese: Ir-rata rakkomandata tal-infużjoni mogħtija taħt sezzjoni 4.2 trid tkun segwita mill-qrib.
English: Ear pain
Maltese: Ż-ŻGĦAR EWLENIN
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (5 g, 10 g and 20 g)
Maltese: KAXXA TAL-KARTUN TA' BARRA (5 g, 10 g u 20 g)
English: • device dislocation
Maltese: • il-piż żejjed
English: Each ml of this medicinal product contains 50 mg of sorbitol.
Maltese: Kull ml ta' dan il-prodott mediċinali fih 50 mg ta' sorbitol.
English: Wheezing
Maltese: Ċijanożi
English: It contains trace amounts of IgA (lower than 50 micrograms/ml).
Maltese: Fiha ammonti traċċi ta' IgA (inqas minn 50 mikrogramma/ml).
English: Body temperature increased
Maltese: Żieda fit-temperatura tal-ġisem
English: The safety results for 4 paediatric patients (those ≤ 17 years old) included in the PID study and the results for the 13 children (aged 3 to 16 years old) included in the ITP study were evaluated.
Maltese: Ir-riżultati tas-sigurtà għal 4 pazjenti pedjatriċi (dawk li għandhom ≤ 17-il sena) inklużi fl-istudju PID u r-riżultati għat-13-il tifel u tifla (li kellhom minn 3 sa 16-il sena) inklużi fl-istudju ITP ġew evalwati.
English: • cases of increased serum creatinine level and/or occurrence of acute renal failure
Maltese: • każijiet ta' żieda fil-livell tal-kreatinina fis-serum u/jew okkorrenza ta' insuffiċjenza akuta renali
English: ● erythema (redness of the skin)
Maltese: ● artralġja (uġigħ fil-ġogi)
English: MM/YYYY
Maltese: Uġigħ ta' ras
English: In persons more than 2 years old with problems to tolerate fructose, a spontaneous reaction for fructose-containing foods develops which may have the following symptoms: vomiting, gastro-intestinal disorders, apathy, height and weight retardation.
Maltese: F'persuni li jkollhom iktar minn sentejn bi problemi li jittolleraw il-fructose, tiżviluppa reazzjoni spontanja għal ikel li jkun fih il-fructose li jista' jkollha s-sintomi li ġejjin: rimettar, disturbi gastrointestinali, apatija, dewmien fl-ilħuq tat-tul u l-piż.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Asthma, Cough, Dyspnoea, Epistaxis, Nasal discomfort, Laryngeal pain
Maltese: Akne, Alopeċja, Ekimożi, Eritema,
English: Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, and patients with diseases which increase blood viscosity).
Maltese: Għandha tingħata attenzjoni meta tingħata riċetta u waqt l-infużjuni ta' IVIg lil pazjenti ħoxnin, u f'pazjenti b'fatturi ta' riskju li kienu jeżistu minn qabel għal avvenimenti trombotiċi (bħal età avvanzata, pressjoni tad-demm għolja, dijabete mellitus u storja medika ta' mard vaskulari jew episodji trombotiċi, pazjenti b'disturbi trombofiliċi miksuba jew li ntirtu, pazjenti li jqattgħu perjodi twal ma jitħarrkux, pazjenti li huma ipovolemiċi b'mod sever, u pazjenti b'mard li jżid il-viskosità tad-demm).
English: Pyrexia
Maltese: Raxx
English: Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration.
Maltese: L-immunoglobulina umana normali hi immedjatament u kompletament bijodisponibbli fiċ-ċirkolazzjoni tal-pazjent wara l-għoti ġol-vini.
English: For patients experiencing adverse reactions, it is advisable to reduce the infusion rate in subsequent infusions and limit the maximum rate to 0.04 ml/kg/min, or administer IVIg at a 5% concentration.
Maltese: Għal pazjenti li jkollhom reazzjonijiet avversi, hu rakkomandat li r-rata tal-infużjoni titnaqqas f'infużjonijiet sussegwenti u li r-rata massima tiġi limitata għal 0.04 ml/kg/min, jew li tingħata IVIg f'konċentrazzjoni ta' 5%.
English: • Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/haemolysis).
Maltese: • Każijiet ta' tnaqqis temporanju fin-numru taċ-ċelluli ħomor tad-demm (anemija emolitika riversibbli/emolisi).
English: • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a rare and progressive disease causing limb weakness, numbness, pain and fatigue.
Maltese: • Poliradikulonewropatija demajelinizzanti infjammatorja kronika (CIDP), marda rari u progressiva li tikkawża dgħufija fir-riġlejn u d-dirgħajn, tnemnim, uġigħ u għeja.
English: Three clinical trials were performed with Flebogamma DIF, two for replacement therapy in patients with primary immunodeficiency (one in both adults and in children above 10 years and another in children between 2 to 16 years) and another for immunomodulation in adult patients with immune thrombocytopenic purpura.
Maltese: Tliet provi kliniċi twettqu bil-Flebogamma DIF, tnejn għat-terapija tas-sostituzzjoni f'pazjenti b'immunodefiċjenza primarja (waħda kemm f'adulti u fi tfal ta' aktar minn 10 snin u oħra fi tfal ta' bejn sentejn u 16-il sena), u l-oħra għall-immunomodulazzjoni f'pazjenti adulti b'purpura tromboċitopenika immuni.
English: ● neck pain
Maltese: ● ħalq xott
English: Potential complications can often be avoided by ensuring that patients: - are not sensitive to human normal immunoglobulin by initially injecting the product slowly (at an initial rate of 0.01 - 0.02 ml/kg/min) - are carefully monitored for any symptoms throughout the infusion period.
Maltese: Kumplikazzjonijiet potenzjali jistgħu ta' spiss jiġu evitati billi tiżgura li l-pazjenti: - ma jkunux sensittivi għal immunoglobulina umana normali billi inizjalment tinjetta l-prodott bil-mod b'rata inizjali ta' 0.01 ml/kg/min. - ikunu mmonitorjati b'attenzjoni għal kwalunkwe sintomi matul il-perjodu kollu tal-infużjoni.
English: You will be watched carefully until an hour after the infusion to detect potential side effects.
Maltese: biex ikunu osservati effetti sekondarji potenzjali.
English: Renal and urinary disorders Urinary retention
Maltese: Disturbi fil-kliewi u fissistema urinarja
English: It contains trace amounts of IgA (lower than 100 micrograms/ml).
Maltese: Il-kontenut massimu ta' IgA hu ta' 100 mikrogramma/ml.
English: How to store Flebogamma DIF
Maltese: X'fih Flebogamma DIF
English: The most reported post-marketing ADRs received since the product was authorised for both concentrations were chest pain, flushing, blood pressure increased and decreased, malaise, dyspnoea, nausea, vomiting, pyrexia, back pain, headache and chills.
Maltese: L-iktar ADRs li ġew irrappurtati wara t-tqegħid fis-suq li ġew riċevuti minn meta l-prodott ġie awtorizzat għaż-żewġ konċentrazzjonijiet kienu wġigħ fis-sider, fwawar, żieda u tnaqqis fil-pressjoni tad-demm, telqa, qtugħ ta' nifs, dardir, rimettar, deni, uġigħ fid-dahar, uġigħ ta' ras u tertir.
English: Limb discomfort, Muscle spasms, Muscle tightness, Neck pain, Pain in extremity
Maltese: Spażmi fil-muskoli, Uġigħ flgħonq, Uġigħ fl-estremitajiet
English: No differences of the pharmacokinetic properties are expected in the paediatric population.
Maltese: Popolazzjoni pedjatrika Mhuma mistennija l-ebda differenzi fil-proprjetajiet farmakokinetiċi fil-popolazzjoni pedjatrika.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial of 10 ml, 50 ml, 100 ml and 200 ml, that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett ta' 10 mL, 50 mL, 100 mL u
English: • nasopharyngitis
Maltese: • sogħla
English: At the beginning of your infusion you will receive Flebogamma DIF at a slow rate (0.01 ml/kg/min).
Maltese: Fil-bidu ta' l-infużjoni tiegħek, inti ser tirċievi Flebogamma DIF b'rata bil-mod (0.01 ml/kg/min).
English: The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Maltese: Id-doża rakkomandata hi ta' 0.2 - 0.4 g/kg kull tlieta sa erba' ġimgħat.
English: Flebogamma DIF is a solution for infusion.
Maltese: Flebogamma DIF hu soluzzjoni għall-infużjoni.
English: Primary immune thrombocytopenia
Maltese: Frekwenza tal-injezzjonijiet
English: In case of inadvertent administration and suspicion of fructose intolerance the infusion has to be stopped immediately, normal glycaemia has to be re-established and organ function has to be stabilized by means of intensive care.
Maltese: Jekk ikun hemm għoti aċċidentali u suspett ta' intolleranza għall-fructose, l-infużjoni għandha titwaqqaf minnufih, il-gliċemija normali trid terġa' tkun stabbilita u l-funzjoni tal-organi trid tkun stabbilizzata permezz ta' kura intensiva.
English: • epistaxis (haemorrhage from the nose)
Maltese: • tinfaġar (emorraġija mill-imnieħer)
English: ● rigors (cold shivering sensation) or chills
Maltese: ● influwenza (flu) ● sturdament (dardir waqt il-moviment/ivvjaġġar)
English: Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
Maltese: L-eżaminazzjoni tat-tossiċità ta' dożi ripetuti u t-tossiċità embrijo-fetali ma kienx prattikabbli minħabba l-induzzjoni ta', u l-interferenza ma' l-antikorpi.
English: Flebogamma DIF is given by injection into your veins (intravenous administration).
Maltese: Flebogamma DIF jingħata permezz ta' injezzjoni ġol-vini tiegħek (amministrazzjoni ġol-vini).
English: This leaflet was last revised in MM/YYYY
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: ● dizziness (motion sickness)
Maltese: ● prurite (ħakk)
English: Flushing, Haematoma, Lymphoedema, Systolic hypertension, Thrombosis
Maltese: (rarament) anemija emolitika li teħtieġ trasfużjoni
English: Replacement therapy in primary immunodeficiency syndromes The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 6 g/l or within the normal reference range for the population age.
Maltese: Il-kors tad-doża għandha tilħaq livell minimu ta' IgG (imkejjel qabel l-infużjoni li jmiss) ta' mill-anqas 6 g/l jew fi ħdan il-medda ta' referenza normali għall-età tal-popolazzjoni.
English: This medicine belongs to the group of medicines called intravenous immunoglobulins.
Maltese: antikorpi kontra organiżmi infettivi.
English: Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Maltese: Distribuzzjoni tas-sottoklassijiet ta' IgG (valuri approssimattivi):
English: ● flushing (to blush)
Maltese: ● fwawar (tiħmar)
English: ● insomnia
Maltese: Infezzjonijiet u
English: ● upper-airway cough syndrome
Maltese: ● uġigħ fl-għonq
English: Nasopharyngitis
Maltese: Sturdament
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (0.5 g)
Maltese: KAXXA TAL-KARTUN TA' BARRA (0.5 g)
English: In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
Maltese: Fil-biċċa l-kbira tal-każijiet, kienu identifikati fatturi ta' riskju, bħal insuffiċjenza renali li kienet teżisti minn qabel, dijabete mellitus, ipovolemija, piż żejjed, użu fl-istess ħin ta' prodotti mediċinali nefrotossiċi jew età ta' aktar minn 65.
English: • injection site reactions (including injection site oedema, pain, pruritus and swelling)
Maltese: • reazzjonijiet fis-sit tal­injezzjoni (inkluż edema, uġigħ, ħakk u nefħa fis-sit tal-injezzjoni)
English: You must make up the infusion in exactly the way you have been shown in order to stop germs getting in. You must never self-administer it alone; a responsible adult must be always present.
Maltese: Qatt m'għandek tagħti l-infużjoni lilek innifsek meta tkun waħdek; persuna adulta responsabbli għandha dejjem tkun preżenti.
English: Flebogamma DIF should not be mixed with other medicines or intravenous solutions and it should be administered by a separate intravenous line.
Maltese: Flebogamma DIF m'għandux jitħallat ma' mediċini jew soluzzjonijiet ġol-vini oħrajn u għandu jingħata permezz ta' linja separata ġol-vini.
English: For safety information with respect to transmissible agents, see section 4.4.
Maltese: Għal informazzjoni dwar is-sigurtà fir-rigward ta' mediċini li jistgħu jiġu trasmessi, ara sezzjoni 4.4.
English: 0.2 - 0.8 g/kg every 3 - 4 weeks
Maltese: manteniment: 0.2 - 0.8 g/kg kull 3 - 4 ġimgħat
English: Immunoglobulins are excreted into human milk.
Maltese: L-immunoglobulini huma eliminati fil-ћalib tas-sider tal-bniedem.
English: • migraine
Maltese: ● uġigħ
English: It has been reported that the frequency of adverse reactions to IVIg increases with the infusion rate.
Maltese: Kien irrappurtat li l-frekwenza ta' reazzjonijiet avversi għal IVIg tiżdied mar-rata tal-infużjoni.
English: Maintenance dose: 1 g/kg in divided doses over 2 - 5 days every 3 weeks over 1 - 2 days
Maltese: manteniment: 1 g/kg f'dożi maqsuma fuq 2 - 5 ijiem kull 3 ġimgħat fuq jum - jumejn