FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva (immunoglobulini umani) jew għal kwalunkwe sustanza mhux attiva (ara sezzjonijiet 4.4 u 6.1).
English: Side effects may be reduced by switching to Flebogamma DIF 50 mg/ml.
Maltese: L-effetti sekondarji jistgħu jitnaqqsu billi taqleb għal Flebogamma DIF 50 mg/ml.
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Maltese: IgG u kumplessi IgG jitkissru fiċ-ċelluli tas-sistema retikuloendoteljali.
English: 0.8 - 1 g/kg or
Maltese: 0.8 - 1 g/kg jew
English: ● alopecia
Maltese: ● alopeċja
English: Abnormal behaviour
Maltese: Imġiba anormali
English: ● feeling jittery (nervousness)
Maltese: ● tħossok nervuż/a (nervożità)
English: Flebogamma DIF is supplied as 5 g/50 ml, 10 g/100 ml and 20 g/200 ml.
Maltese: Flebogamma DIF hu fornut bħala 5 g/50 ml, 10 g/100 ml u 20 g/200 ml.
English: Transfusion related acute lung injury (TRALI)
Maltese: Leżjoni akuta fil-pulmun relatata mat-trasfużjoni (TRALI, transfusion related acute lung injury)
English: Alanine aminotransferase increased, Blood pressure increased
Maltese: Żieda f'alanine aminotransferase,
English: In a Post-authorisation Safety Study that included 66 patients, Flebogamma DIF 100 mg/ml showed a higher rate (18.46%, n=24/130) of infusions associated with potentially related adverse events than Flebogamma DIF 50 mg/ml (2.22%, n=3/135).
Maltese: 100 mg/ml wera rata ogħla (18.46%, n=24/130) ta' infużjonijiet assoċjati ma' avvenimenti avversi potenzjalment relatati milli minn Flebogamma
English: • reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
Maltese: • reazzjonijiet emolitiċi riversibbli, speċjalment f'dawk il-pazjenti bi gruppi tad-demm A, B, u AB u (rarament) anemija emolitika li teħtieġ trasfużjoni
English: ● fever (body temperature increased)
Maltese: ● deni (żieda fit-temperatura tal-ġisem)
English: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Maltese: Poliradikulonewropatija demajelinizzanti infjammatorja kronika (CIDP, Chronic inflammatory demyelinating polyradiculoneuropathy)
English: ● rash
Maltese: ● raxx
English: Replacement therapy: Primary immunodeficiency syndromes
Maltese: Terapija tas-sostituzzjoni f'sindromi tal-immunodefiċjenza primarja
English: • cases of Transfusion Related Acute Lung Injury (TRALI)
Maltese: • każijiet ta' Leżjoni Akuta fil-Pulmun Relatata mat-Trasfużjoni (TRALI)
English: IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coomb's test) and, rarely, haemolysis.
Maltese: Prodotti li fihom IVIg jista' jkun fihom antikorpi għal gruppi tad-demm li jistgħu jaġixxu bħala hemolysins u jikkaġunaw kisja in vivo ta' ċelluli tad-demm ħomor b'immunoglobulina, li tikkawża reazzjoni pożittiva għal antiglobulina diretta (Coomb's test) u, rarament, emolisi.
English: Flebogamma DIF 50 mg/ml has a half-life of about 30 - 32 days.
Maltese: Flebogamma DIF 50 mg/ml għandu half-life ta' madwar 30-32 jum.
English: Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin Each vial of 100 ml contains: 5 g of human normal immunoglobulin Each vial of 200 ml contains: 10 g of human normal immunoglobulin Each vial of 400 ml contains: 20 g of human normal immunoglobulin
Maltese: Kull kunjett ta' 10 ml fih: 0.5 g ta' immunoglobulina umana normali Kull kunjett ta' 50 ml fih: 2.5 g ta' immunoglobulina umana normali Kull kunjett ta' 100 ml fih: 5 g ta' immunoglobulina umana normali Kull kunjett ta' 200 ml fih: 10 g ta' immunoglobulina umana normali Kull kunjett ta' 400 ml fih: 20 g ta' immunoglobulina umana normali
English: • Patients with Primary Immunodeficiency Syndromes (PID), an inborn lack of antibodies (group 1)
Maltese: • Pazjenti b'Sindromi ta' Immunodefiċjenza Primarja (PID), nuqqas konġenitali (li titwieled bih)
English: Frequency per infusion
Maltese: Frekwenza kull infużjoni
English: The maximum IgA content is 50 micrograms/ml.
Maltese: Il-kontenut massimu ta' IgA hu 50 mikrogramma/ml.
English: Flebogamma DIF 100 mg/ml has a half-life of about 34 - 37 days.
Maltese: Flebogamma DIF 100 mg/ml għandu half-life ta' madwar 34-37 jum.
English: Dermatitis contact, Hyperhidrosis, Rash
Maltese: Dermatite tal-kuntatt, Iperidrożi,
English: Source of the safety database from clinical trials and post-authorisation safety studies in a total of 160 patients exposed to Flebogamma DIF 100 mg/ml (with a total of 915 infusions)
Maltese: Sors tad-database tas-sigurtà minn provi kliniċi u studji tas-sigurtà ta' wara lawtorizzazzjoni f'total ta' 160 pazjent esposti għal Flebogamma DIF 100 mg/mL (b'total ta' 915-il infużjoni)
English: The maximum IgA content is 100 micrograms/ml.
Maltese: Il-kontenut massimu ta' IgA hu 100 mikrogramma/ml.
English: • infusion site reactions (erythema, extravasation, inflammation, pain)
Maltese: • reazzjonijiet fis-sit tal-infużjoni (eritema, ekstravassazzjoni, infjammazzjoni, uġigħ)
English: Treatment of adults, children and adolescents (2 - 18 years) with certain autoimmune disorders (immunomodulation).
Maltese: Kura ta' persuni adulti, tfal u adolexxenti (sentejn sa 18-il sena) b'ċerti disturbi awtoimmuni (immunomodulazzjoni).
English: This medicinal product contains less than 29,41 mg sodium per vial of 400 ml, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih anqas minn 29,41 mg sodium għal kunjett ta' 400 mL, ekwivalenti għal 1.5% tal-ammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: Source of the safety database from clinical trials and post-authorisation safety studies in a total of 128 patients exposed to Flebogamma DIF 50 mg/ml (with a total of 1318 infusions)
Maltese: Sors tad-database tas-sigurtà minn provi kliniċi u studji tas-sigurtà ta' wara l-awtorizzazzjoni f'total ta' 128 pazjent esposti għal Flebogamma DIF 50 mg/mL (b'total ta' 1318-il infużjoni)
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 and parvovirus B19 viruses.
Maltese: Il-miżuri meħuda huma kkunsidrati li huma effettivi għal viruses enveloped bħal virus talimmunodefiċjenza umana (HIV), virus tal-epatite B (HBV) u virus tal-epatite Ċ (HCV), u għal viruses non-enveloped tal-epatite A u viruses tal-parvovirus B19.
English: Assessment of vital signs in clinical trials of the paediatric population did not indicate any pattern of clinically relevant changes.
Maltese: L-evalwazzjoni tas-sinjali vitali fil-provi kliniċi tal-popolazzjoni pedjatrika ma indikatx kwalunkwe andament ta' tibdil kliniku rilevanti.
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 MedDRA (SOC u Livell ta' Terminu Ppreferut).
English: MARKETING AUTHORISATION HOLDER Instituto Grifols, S.A.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Instituto Grifols, S.A.
English: This typically occurs within hours or days after IVIg administration and resolves spontaneously within 7 to 14 days.
Maltese: Dan tipikament iseħħ fi żmien sigħat jew jiem wara għoti ta' IVIg u jfieq b'mod spontanju fi żmien 7 sa 14-il jum.
English: Passive transmission of antibodies to erythrocyte 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 eritroċiti, eż. A, B, D, tista' tinterferixxi ma' xi testijiet seroloġiċi għal antikorpi taċ-ċelluli ħomor, pereżempju t-test dirett tal-antiglobulina (DAT, it-test dirett ta' Coomb).
English: Loop diuretics Avoidance of concomitant use of loop diuretics
Maltese: Dijuretiċi tal-loop (Loop diuretics)
English: Arthralgia, Musculoskeletal discomfort Uncommon
Maltese: Artralġja, Skonfort muskuloskeletriku Mhux komuni
English: • hypersensitivity
Maltese: • sensittività eċċessiva
English: The measures taken 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 and parvovirus B19 viruses.
Maltese: Il-miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses enveloped bħal virus ta' l-immunodefiċjenza umana (HIV), il-virus ta' l-epatite B u l-virus ta' l-epatite C, u għal viruses non-enveloped ta' l-epatite A u parvovirus B19.
English: Flebogamma DIF contains sodium
Maltese: Flebogamma DIF fih is-sodium
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)
Maltese: Poliradikulonewropatija demajelinizzanti infjammatorja kronika (CIDP, Chronic inflammatory demyelinating polyneuropathy)
English: Flebogamma DIF is supplied as 0.5 g/10 ml, 2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml and 20 g/400 ml vials.
Maltese: Flebogamma DIF hu fornut bħala kunjetti ta' 0.5 g/10 ml, 2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml u
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Indication
Maltese: Indikazzjoni
English: 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
Maltese: 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
English: 10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih 50 ml, 100 ml jew 200 ml soluzzjoni f'kunjett (ħġieġ ta' tip II) b'tapp (chloro-butyl-lastku).
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Maltese: acetylsalicylic acid
English: Patients with rare hereditary problems of fructose intolerance must not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose, m'għandhomx jieħdu din il-mediċina.
English: Pruritus, Rash
Maltese: Ħakk, Raxx
English: ● hypersensitivity
Maltese: ● sensittività eċċessiva
English: ● tachycardia (acceleration of the heart activity)
Maltese: ● takikardija (aċċellerazzjoni tal-attività tal-qalb)
English: ● anorexia (lack of appetite)
Maltese: ● anoreksja (nuqqas ta' aptit) • insomnja
English: • Effects on vaccines: Flebogamma DIF may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines).
Maltese: • Effetti fuq il-vaċċini: Flebogamma DIF jista' jnaqqas l-effettività ta' ċerti tipi ta' tilqim (tilqim b'virus ħaj attenwat).
English: ● muscle spasms and muscle tightness
Maltese: ● spażmi tal-muskoli u tħoss il-muskoli miġbudin
English: ● vision blurred
Maltese: ● vista mċajpra
English: No negative effects on the breastfed newborns/infants are anticipated.
Maltese: Mhux mistenni li jkun hemm effetti negattivi fuq trabi tat-twelid li qegћdin jiġu mreddgћin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (2.5 g, 5 g, 10 g and 20 g)
Maltese: KAXXA TAL-KARTUN TA' BARRA (2.5 g, 5 g, 10 g u 20 g)
English: ● maculopathy (illness of the macula, in the retina of the eyes)
Maltese: ● makulopatija (mard tal-makula, fir-retina tal-għajnejn)
English: Immunomodulation in adults, children and adolescents (2 - 18 years) in: - Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count - Guillain Barré syndrome - Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2) - Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - Multifocal motor neuropathy (MMN)
Maltese: - Sindromu ta' Guillain Barré - Il-marda ta' Kawasaki (flimkien ma' acetylsalicylic acid; ara 4.2) - Poliradikulonewropatija demajelinizzanti infjammatorja kronika (CIDP, Chronic inflammatory demyelinating polyradiculoneuropathy)
English: There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including stroke), pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients.
Maltese: Hemm evidenza klinika ta' rabta bejn l-għoti ta' IVIg u avvenimenti tromboemboliċi bħal infart mijokardijaku, inċident ċerebrali vaskulari (li jinkludi puplesija), emboliżmu pulmonari u trombożi talvini profondi li hu ssoponut li huma relatati ma żieda relattiva fil-viskosità tad-demm minħabba l-influss qawwi ta' immunoglobulin f'pazjenti li qegħdin f'riskju.
English: Treatment of adults, children and adolescents (2 - 18 years) who do not have sufficient antibodies (Flebogamma DIF is used as replacement therapy).
Maltese: Kura ta' persuni adulti, tfal u adolexxenti (sentejn sa 18-il sena) li m'għandhomx antikorpi biżżejjed (Flebogamma DIF jintuża bħala terapija ta' sostituzzjoni).
English: Flebogamma DIF contains human normal immunoglobulin, highly purified protein extracted from human plasma (part of the blood of donors).
Maltese: Flebogamma DIF fih immunoglobulina normali umana proteina mill-aktar ippurifikata estratta mill plażma tal-bniedem (parti mid-demm tad-donaturi).
English: Blood pressure systolic increased, Body temperature increased, Coombs test positive
Maltese: Żieda fil-pressjoni tad-demm sistolika, Żieda fit-temperatura talġisem, Riżultati pożittivi għat-test ta' Coombs
English: ● ecchymosis (large skin haematoma)
Maltese: ● meninġite asettika (meninġite mhux infettiva)
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 (see section 4.4).
Maltese: Għal pazjenti li jkollhom reazzjonijiet avversi, hu rakkomandat li r-rata tal-infużjoni titnaqqas f'infużjonijiet sussegwenti u tillimita r-rata massima għal 0.04 ml/kg/min jew li tingħata IVIg f'konċentrazzjoni ta' 5% (ara sezzjoni 4.4).
English: Hypersensitivity reactions are rare.
Maltese: Reazzjonijiet allerġiċi huma rari.
English: • Patients with Secondary Immunodeficiency Syndromes (SID) with severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l (group 2)
Maltese: • Pazjenti b'Immunodefiċjenzi Sekondarji (SID) b'infezzjonijiet severi jew rikorrenti, trattament antimikrobiku mhux effettiv, u insuffiċjenza tal-antikorp speċifika u pprovata (PSAF)* jew livell ta' IgG fis-serum ta' <4 g/L (grupp 2)
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Maltese: Każijiet ta' insuffiċjenza akuta renali kienu rrappurtati f'pazjenti li kienu qed jirċievu terapija b'IVIg.
English: Primary immunodeficiency syndromes Starting dose:
Maltese: Sindromi tal-immunodefiċjenza primarja Doża tal-bidu:
English: Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.
Maltese: għall-għoti intravaskulari, Kodiċi ATC: J06BA02 L-immunoglobulina umana normali primarjament fih immunoglobulin G (IgG) b'firxa wiesgħa ta'
English: While reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Maltese: IVIg liċenzjati li fihom diversi eċċipjenti bħal sucrose, glucose u maltose, dawk il-prodotti li fihom is-sucrose bħala stabbilizzatur, ammontaw għal porzjon sproporzjonat tan-numru totali.
English: • abnormal behaviour
Maltese: • imġiba anormali
English: Acne, Alopecia, Ecchymosis, Erythema, Hyperhidrosis, Palmar erythema, Purpura
Maltese: • tertir ta' bard, uġigħ ta' ras, sturdament, deni, rimettar, reazzjonijiet allerġiċi, dardir, artralġja,
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
Maltese: Hemm esperjenza klinika inkoraġġanti dwar in-nuqqas ta' trasmissjoni ta' epatite A jew ta' parvovirus B19 permezz ta' l-immunoglobulini, u hu ssoponut ukoll li l-kontenut ta' l-antikorpi għandu sehem importanti fis-sigurtà virali.
English: - If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced.
Maltese: - Jekk għandek intolleranza għal fructose, kundizzjoni ġenetika pjuttost rari fejn l-enzima li tkisser il-fructose ma tiġix prodotta.
English: Grifols UK Ltd. Tel: +44 845 2413090
Maltese: Tel: +44 845 2413090
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL (0.5 g and 2.5 g)
Maltese: TIKKETTA TAL-KUNJETT (0.5 g u 2.5 g)
English: 0.4 g/kg/day over 5 days (possible repeat of dosing in case of relapse).
Maltese: 0.4 g/kg/kuljum fuq perjodu ta' 5 ijiem (possibbilità li jiġi rripetut id-dożaġġ f'każ ta' rikaduta).
English: • history of vascular disease or thrombosis
Maltese: • storja medika ta' mard jew trombożi vaskulari
English: Back pain, Arthralgia, Myalgia
Maltese: Uġigħ fid-dahar, Artralġja, Mijalġja
English: ● Coombs test positive
Maltese: ● riżultati pożittivi għat-test ta' Coombs
English: Dizziness, Tremor
Maltese: Deni, Tertir
English: There are two alternative treatment schedules:
Maltese: Hemm żewġ skedi ta' kura alternattiva:
English: In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations.
Maltese: F'każijiet rari u iżolati, l-effetti sekondarji li ġejjin ġew rapportati bi preparazzjonijiet ta' immunoglobini.
English: The recommended starting dose is 0.4 - 0.8 g/kg given once followed by at least 0.2 g/kg given every three to four weeks.
Maltese: Id-doża inizjali rakkomandata hi ta' 0.4 - 0.8 g/kg mogħtija darba segwita minn ta' mill-anqas 0.2 g/kg/xahar mogħtija kull tlieta sa erba' ġimgħat.
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: Flebogamma DIF 100 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Maltese: Flebogamma DIF 100 mg/ml hu kontraindikat fi tfal li għandhom bejn 0 u sentejn (ara sezzjoni 4.3).
English: • asthma
Maltese: • ażżma
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandha tiġi implimentata kura medika standard għal xokk.
English: • Multifocal motor neuropathy (MMN), a rare disease causing slow progressive asymmetric limb weakness without sensory loss.
Maltese: • Newropatija motriċi multifokali (MMN), marda rari li tikkawża dgħufija progressiva asimettrika fir-riġlejn u d-dirgħajn mingħajr telf tas-sensazzjoni.
English: It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 - 5 days equilibrium is reached between the intra- and extravascular compartments.
Maltese: Hu ddistribwit relattivament malajr bejn il-plażma u l-fluwidu extravaskulari, u wara madwar 3-5 ijiem l-ekwilibriju jintlaħaq bejn il-kompartimenti intra- u extra-vaskulari.
English: Asthenia, Chest pain, Infusion site erythema, Infusion site extravasation, Infusion site inflammation, Infusion site pain, Injection site oedema, Injection site pain, Injection site pruritus, Injection site swelling, Oedema peripheral
Maltese: Skonfort fis-sider, Uġigħ fis-sider, Għeja, Tħoss il-bard, Reazzjoni fis-sit tal-infużjoni, Ma tħossokx tajjeb b'mod ġenerali, Edema periferali, Uġigħ
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.5% tal-ammont massimu rakkomandat ta' sodium li għandu jittieħed kuljum maddieta minn adult.
English: Flebogamma DIF 50 mg/ml is contraindicated in children aged 0 to 2 years (see section 4.3).
Maltese: Flebogamma DIF 50 mg/ml hu kontraindikat fi tfal li għandhom bejn 0 u sentejn (ara sezzjoni 4.3).
English: If the patient tolerates the infusion well, additional increments of 0.02 ml/kg/min may be made at 30-minute intervals up to a maximum of 0.08 ml/kg/min.
Maltese: Jekk ilpazjent jittollera l-infużjoni tajjeb, jistgħu jsiru inkrementi addizzjonali ta' 0.02 ml/kg/min f'intervalli ta' 30 minuta sa massimu ta' 0.08 ml/kg/min.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml contains 100 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Millilitru wieħed fih 100 mg ta' immunoglobulina umana normali (IVIg), li minnha, mill-anqas 97% hi IgG.
English: • Primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced.
Maltese: • Tromboċitopenija immuni primarja (ITP), kundizzjoni fejn in-numru ta' plejtlits fiċ-ċirkolazzjoni tad-demm jonqos bil-kbir.
English: IVIg products have been shown to cross the placenta, increasingly during the third trimester.
Maltese: Intwera li prodotti IVIg li jingħataw lil nisa tqal jgħaddu minn ġol-plaċenta, u dan jiżdied matul it-tielet trimestru.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Replacement therapy in adults, children and adolescents (2 - 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
Maltese: - Sindromi ta' immunodefiċjenza primarja (PID, primary immunodeficiency syndromes) b'indeboliment fil-produzzjoni ta' antikorpi - Immunodefiċjenzi sekondarji (SID, secondary immunodeficiencies) f'pazjenti li jsofru minn infezzjonijiet severi jew rikorrenti, trattament antimikrobiku mhux effettiv, u insuffiċjenza talantikorp speċifika u pprovata (PSAF, proven specific antibody failure)* jew livell ta' IgG fisserum ta' <4 g/L
English: Grifols Italia S.p.A. Tel: +39 050 8755 113
Maltese: Tel: +39 050 8755 113
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Maltese: Kunjett 1 Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (5 g, 10 g and 20 g)
Maltese: TIKKETTA TAL-KUNJETT (5 g, 10 g u 20 g)
English: Flebogamma DIF 100 mg/ml should be infused intravenously at an initial rate of 0.01 ml/kg/min for the first thirty minutes.
Maltese: Flebogamma DIF 100 mg/ml għandu jingħata bħala infużjoni fil-vini b'rata inizjali ta' 0.01 ml/kg/min għall-ewwel tletin minuta.
English: 0.2 - 0.4 g/kg every 3 - 4 weeks
Maltese: 0.2 - 0.4 g/kg kull 3 - 4 ġimgħat