FrancophonIA/ELRC3.0 huggingface dataset:
English: • endocarditis (infection of the inner lining of the heart - most commonly the valves of the heart);
Maltese: • endokardite (infezzjoni tal-kisja ta' ġewwa tal-qalb - ħafna drabi l-valvi tal-qalb);
English: Patients should be particularly carefully monitored if given higher initial doses (12 mg per kg body-weight twice daily).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni partikolari jekk jingħataw dożi inizjali ogħla (12 mg għal kull kg tal-piż tal-ġisem darbtejn kuljum).
English: The Committee asked the company that markets the medicine to submit a risk management plan for the safe use of Targocid, including a study to monitor the safety of the increased initial dose recommendations (12 mg per kg body-weight twice daily).
Maltese: Il-Kumitat talab lill-kumpanija li tqiegħed il-mediċina fis-suq biex tippreżenta pjan għall-ġestjoni tarriskju għall-użu sigur ta' Targocid, fosthom studju biex jimmonitorja s-sigurtà tar-rakkomandazzjonijiet taż-żieda fid-doża inizjali (12 mg għal kull kg tal-piż tal-ġisem darbtejn kuljum).
English: Targocid should be used to treat severe infections where standard antibiotic treatment is not suitable.
Maltese: Targocid għandu jintuża għall-kura ta' infezzjonijiet severi fejn kura standard bl-antibijotiċi ma tkunx addattata.
English: The Committee also agreed that Targocid could be taken by mouth to treat diarrhoea and colitis (inflammation of the bowel) associated with infection by bacteria called Clostridium difficile.
Maltese: Il-Kumitat qabel ukoll li Targocid jista' jittieħed mill-ħalq għall-kura tad-dijarea u l-kolite (infjammazzjoni tal-musrana) assoċjati ma' infezzjoni minn batterju msejjaħ Clostridium difficile.
English: • complicated infections of the skin and soft-tissues;
Maltese: • infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Targocid in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni dwar il-preskrizzjoni ta' Targocid tiġi armonizzata fl-Unjoni Ewropea (UE).
English: The CHMP agreed that Targocid should be used by injection or infusion to treat the following infections in adults and children:
Maltese: Is-CHMP qabel li Targocid għandu jintuża permezz ta' injezzjoni jew infużjoni għall-kura talinfezzjonijiet li ġejjin fl-adulti u t-tfal:
English: It can also be given by mouth to treat diarrhoea and colitis (inflammation of the bowel) caused by infection with a bacterium called Clostridum difficile.
Maltese: Jista' wkoll jingħata mill-ħalq għall-kura taddijarea u l-kolite (infjammazzjoni tal-musrana) ikkawżati minn infezzjoni b'batterju msejjaħ Clostridum difficile.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-dejta sottomessa u d-diskussjoni xjentifika fi ħdan il-Kumitat, kien tal-opinjoni li l-SmPCs, it-tikkettar u l-fuljetti ta' tagħrif għandhom jiġu armonizzati madwar l-UE.
English: Further information on Sovaldi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • rifampicin and rifabutin (antibiotics);
Maltese: • rifampicin u rifabutin (antibijotiċi);
English: • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy).
Maltese: • carbamazepine, phenobarbital u phenytoin (mediċini għall-epilessija).
English: Sovaldi is available as 400 mg tablets.
Maltese: Sovaldi jiġi bħala pilloli ta' 400 mg.
English: Sovaldi received a marketing authorisation valid throughout the EU on 16 January 2014.
Maltese: Sovaldi ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Jannar 2014.
English: Sovaldi contains the active substance sofosbuvir.
Maltese: Sovaldi fih is-sustanza attiva sofosbuvir.
English: • St. John's wort (a herbal preparation used to treat depression and anxiety);
Maltese: • St John's wort (preparazzjoni erbali li tintuża biex tikkura d-dipressjoni u l-ansjetà);
English: Other information about Sovaldi
Maltese: Informazzjoni oħra dwar Sovaldi
English: Treatment with Sovaldi was as effective (67% patients - 171 out of 256 - had no sign of the virus) as peginterferon-based treatment (67% of patients - 162 out of 243).
Maltese: Il-kura b'Sovaldi kienet effettiva (67 % tal-pazjenti - 171 minn 256 - ma kellhom l-ebda sinjal tal-virus) daqs kura bbażata fuq peginterferon (67 % tal-pazjenti - 162 minn 243).
English: What are the risks associated with Sovaldi?
Maltese: X'inhuma r-riskji assoċjati ma' Sovaldi?
English: The active substance in Sovaldi, sofosbuvir, blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase' in the hepatitis C virus, which is essential for the virus to multiply.
Maltese: Is-sustanza attiva f'Sovaldi, is-sofosbuvir, timblokka l-azzjoni ta' proteina msejħa ‘polimerażi tal-RNA dipendenti mill-NS5B RNA' fil-virus tal-epatite Ċ, li hija essenzjali biex il-virus jimmultiplika.
English: Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa and ribavirin.
Maltese: Sovaldi għandu jintuża f'kombinazzjoni ma' mediċini oħra li jintużaw għall-kura ta' epatite Ċ kronika, bħal ribavirin jew peginterferon alfa u ribavirin.
English: • The third study involved 278 patients with genotypes 2 or 3 hepatitis C virus who could not take or did not want to have treatment with interferon.
Maltese: • It-tielet studju involva 278 pazjent bil-ġenotipi 2 jew 3 tal-virus tal-epatite Ċ li ma setgħux jieħdu jew li ma ridux jieħdu kura b'interferon.
English: This study investigated 12 weeks of treatment with Sovaldi and ribavirin compared with placebo (a dummy treatment) and found that 78% (161 out of 207) of patients taking Sovaldi and ribavirin had no sign of the hepatitis C virus 12 weeks after the end of treatment, whereas none of 71 patients taking placebo were free of the virus.
Maltese: Dan l-istudju investiga 12-il ġimgħa ta' kura b'Sovaldi u ribavirin meta mqabbla mal-plaċebo (kura finta) u sab li 78 % (161 minn 207) tal-pazjenti li kienu qed jieħdu Sovaldi u ribavirin ma kellhom l-ebda sinjal tal-virus tal-epatite Ċ 12-il ġimgħa wara ttmiem tal-kura, filwaqt li l-ebda wieħed mill-71 pazjent li kienu qed jieħdu plaċebo ma kienu ħielsa mill-virus.
English: Sovaldi can be used in all 6 varieties (genotypes) of hepatitis C virus.
Maltese: Sovaldi jista' jintuża fis-6 varjetajiet (ġenotipi) kollha tal-virus tal-epatite Ċ.
English: The most common side effects with Sovaldi in combination with ribavirin and peginterferon alfa were similar to those commonly reported with ribavirin or peginterferon alfa and included fatigue (tiredness), headache, nausea (feeling sick) and insomnia (difficulty sleeping).
Maltese: L-effetti sekondarji l-aktar komuni b'Sovaldi flimkien ma' ribavirin u peginterferon alfa kienu simili għal dawk ta' spiss irrapportati b'ribavirin jew peginterferon alfa u kienu jinkludu eżawriment (għeja), uġigħ ta' ras, nawżja (tħossok ma tiflaħx) u insomnja (diffikultà biex torqod).
English: Sovaldi has been investigated in four main studies involving a total of 1,305 adult patients infected with hepatitis C. In all four studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.
Maltese: Sovaldi ġie investigat f'erba' studji ewlenin li involvew total ta' 1,305 pazjenti infettati bl-epatite Ċ.
English: Additional studies showed that Sovaldi in combination with ribavirin decreased the risk of infection of the new liver with hepatitis C virus in adult patients undergoing transplantation, that Sovaldi is also effective in patients infected with both hepatitis C and HIV, and that the outcome of patients with genotype 3 infection could be improved by extending treatment to 24 weeks.
Maltese: Studji addizzjonali wrew li Sovaldi flimkien ma' ribavirin naqqas ir-riskju ta' infezzjoni tal-fwied il-ġdid bil-virus tal-epatite Ċ f'pazjenti adulti li kienu għaddejjin minn trapjant, li Sovaldi huwa effettiv ukoll f'pazjenti infettati kemm bl-epatite Ċ kif ukoll bl-HIV, u li l-eżitu ta' pazjenti b'infezzjoni tal-ġenotip 3 seta' jitjieb jekk il-kura tiġi estiża għal 24 ġimgħa.
English: In this study, 50% (51 out of 103) of patients taking Sovaldi and ribavirin for 12 weeks had no sign of the hepatitis C virus, compared with 71% (70 out of 98) of patients treated for 16 weeks.
Maltese: F'dan l-istudju, 50 % (51 minn 103) tal-pazjenti li kienu qed jieħdu Sovaldi u ribavirin għal 12-il ġimgħa ma kellhom l-ebda sinjal tal-virus tal-epatite Ċ, meta mqabbla ma' 71% (70 minn 98) tal-pazjenti kkurati għal 16-il ġimgħa.
English: In this study, 91% (296 out of 327) of patients had no sign of the virus 12 weeks after the end of treatment.
Maltese: F'dan l-istudju, 91 % (296 minn 327) tal-pazjenti ma kellhom l-ebda sinjal tal-virus 12-il ġimgħa wara t-tmiem tal-kura.
English: • The first study involved 327 previously untreated patients who were infected with hepatitis C virus of genotypes 1, 4, 5 or 6, and who were given Sovaldi together with two other antiviral medicines,
Maltese: • Fl-ewwel studju pparteċipaw 327 pazjent li ma kinux irċevew kura preċedenti li kienu nfettati bilvirus tal-epatite Ċ tal-ġenotipi 1, 4, 5 jew 6, u li ngħataw Sovaldi flimkien ma' żewġ mediċini antivirali oħra, peginterferon alfa u ribavirin, għal 12-il ġimgħa.
English: Sovaldi is an antiviral medicine used in combination with other medicines to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infection caused by the hepatitis C virus that affects the liver.
Maltese: Sovaldi huwa mediċina antivirali li tintuża flimkien ma' mediċini oħra biex tikkura adulti u tfal mill-età ta' 12-il sena ‘il fuq b'epatite Ċ kronika (fit-tul), infezzjoni kkawżata mill-virus tal-epatite Ċ li jaffettwa l-fwied.
English: • The fourth study involved 201 patients with hepatitis C virus (genotypes 2 or 3) whose infection did not improve on previous treatment with interferon or whose infections came back.
Maltese: • Ir-raba' studju sar fuq 201 pazjent bil-virus tal-epatite Ċ (ġenotipi 2 jew 3) li l-infezzjoni tagħhom ma tjibitx fuq kura preċedenti b'interferon jew li l-infezzjonijiet tagħhom reġgħu tfaċċaw.
English: Blood tests 12 weeks after the end of treatment showed no sign of the virus in 96% of patients (48 out of 50) aged 12 to 18 years.
Maltese: It-testijiet tad-demm 12-il ġimgħa wara t-tmiem tal-kura ma wrew lebda sinjal tal-virus f'96 % tal-pazjenti (48 minn 50) li kellhom bejn 12 u 18-il sena.
English: The duration of treatment will depend on the genotype of the virus the patient is infected with and on which medicines are used with Sovaldi.
Maltese: Id-durata talkura se tiddependi mill-ġenotip tal-virus li l-pazjent ikun infettat bih u minn liema mediċini jintużaw ma' Sovaldi.
English: In addition, virus resistance to Sovaldi is very uncommon and Sovaldi works against all types of hepatitis C virus.
Maltese: Barra minn hekk, ir-reżistenza tal-virus għal Sovaldi hija rari u Sovaldi jaħdem kontra t-tipi kollha tal-virus tal-epatite Ċ.
English: As for all medicines, data on the use of Sovaldi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Sovaldi hija ssorveljata kontinwament.
English: This study compared Sovaldi and ribavirin taken for 12 weeks with Sovaldi and ribavirin taken for 16 weeks.
Maltese: Dan listudju qabbel Sovaldi u ribavirin li ttieħdu għal 12-il ġimgħa ma' Sovaldi u ribavirin li ttieħdu għal 16-il ġimgħa.
English: Results in children aged below 12 years are not yet available.
Maltese: Riżultati fi tfal li għandhom inqas minn 12-il sena għadhom mhumiex disponibbli.
English: Sovaldi allows the virus to be cleared without the patient having to take peginterferon alfa or with only short courses of this medicine (which can cause serious side effects, including reduced growth in adolescents).
Maltese: Sovaldi jippermetti li l-virus jitneħħa mingħajr ma l-pazjent ikollu jieħu peginterferon alfa jew b'korsijiet qosra ta' din il-mediċina biss (li jistgħu jikkawżaw effetti sekondarji serji, inkluż tkabbir imnaqqas fl-adolexxenti).
English: The company that markets Sovaldi will carry out a study in patients who have had liver cancer to evaluate the risk of the cancer returning after treatment with direct-acting antivirals such as Sovaldi.
Maltese: Il-kumpanija li tqiegħed Sovaldi fis-suq se tagħmel studju f'pazjenti li kellhom kanċer tal-fwied sabiex tevalwa r-riskju li l-kanċer jirritorna wara kura b'antivirali b'azzjoni diretta bħal Sovaldi.
English: Sovaldi is being investigated in one main study in children and adolescents aged between 3 and 18 years infected with hepatitis C virus genotypes 2 or 3.
Maltese: Sovaldi qed jiġi investigat fi studju ewlieni wieħed fit-tfal u fl-adolexxenti li għandhom bejn it-3 snin u t-18-il sena infettati bil-virus tal-epatite Ċ tal-ġenotipi 2 jew 3. Il-pazjenti infettati bil-virus tal-epatite Ċ tal-ġenotip 2 irċivew Sovaldi ma' ribavirin għal 12-il ġimgħa u dawk infettati bil-ġenotip 3 irċivew ilkombinazzjoni għal 24 ġimgħa.
English: Sovaldi must not be used together with certain types of medicines which can reduce the effects of Sovaldi.
Maltese: Sovaldi m'għandux jintuża flimkien ma' ċerti tipi ta' mediċini li jistgħu jnaqqsu l-effetti ta' Sovaldi.
English: What measures are being taken to ensure the safe and effective use of Sovaldi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Sovaldi?
English: EMA Number
Maltese: Numru ta' l-EMA Isem
English: Summary of the report from the BPWP and CHMP position:
Maltese: Sommarju tar-rapport mill-pożizzjoni tal-BPWP u tal-CHMP:
English: UMAN BIG belongs to the pharmacological class of immune sera and human specific immunoglobulins for intramuscular administration and contains 100-180 g/l of plasma proteins with at least 90% of them representing Immunoglobulin G (IgG).
Maltese: BIG jappartjeni għall-klassi farmakoloġika ta' sera immuni u ta' immunoglobulini speċifiċi umani għal għoti ġol-muskoli u fih 100-180 g/l ta' proteini tal-plażma b'għallinqas 90% minnhom jirrappreżentaw Immunoglobulina G (IgG).
English: Levels of antibodies of ≥100IU/ml were achieved.
Maltese: Intlaħqu livelli ta' antikorpi ta' ≥100IU/ml.
English: 180 IU/ml
Maltese: 180 UI/ml
English: (Invented) NameStrength Pharmaceutical Form
Maltese: Isem Ivvintat Qawwa Għamla Farmaċewtika
English: UMAN BIG is a plasma derived medicinal product preparation of immunoglobulins (mainly IgG) with a specifically high content of antibodies against the hepatitis B virus surface antigen (HBsAg).
Maltese: BIG huwa preparat mediċinali ta' immunoglobulini (prinċipalment IgG) derivat mill-plażma b'kontenut speċifikament għoli ta' antikorpi kontra l-antiġene ta' superfiċje tal-virus tal-epatite B (HBsAg). UMAN
English: Limited cases of nausea, vomiting, hypotension, tachycardia, allergic or anaphylactic reactions have also been reported.
Maltese: Ġew ukoll rappurtati każijiet limitati ta' nawżea, remettar, ipotensjoni, takikardija, reazzjonijiet allerġiċi jew anafilattiċi.
English: GROUNDS FOR OPINION
Maltese: RAĠUNIJIET GĦAL OPINJONI
English: UMAN BIG 180 I.E./ml
Maltese: BIG 180 I.E./ml
English: IU/ml solution for injection
Maltese: IU/ml Soluzzjoni għall-injezzjoni
English: The Applicant also provided exposure data, stating that a total of about 143,589 injections were given to patients.
Maltese: L-Applikant ipprovda wkoll dejta dwar l-espożizzjoni u ddikjara li bħala total ingħataw madwar 143,589 injezzjoni lillpazjenti.
English: Monograph (0722) and has shown a PK and safety profile within the expected ranges of an immunoglobulin, in a study in stabilized HBsAg/HBeAg negative post-liver transplant patients.
Maltese: BIG jaderixxi mal-monografija tal-Farmakopea Ewropea (0722) u wera profil farmakokinetiku u ta' sigurtà fi ħdan il-livelli mistennija ta' immunoglobulina, fi studju fuq pazjenti wara t-trapjant tal-fwied b'HbsAg/HbeAg negattivi stabbilizzati.
English: The Applicant provided a summary of the available post-marketing experience data for both UMAN BIG and IMMUNOHBs (a different brand name an identical product with the same pack sizes and concentration, produced by the same manufacturing sites, using the same manufacturing process), indicating that approximately 143,381,160 IU of IMMUNOHBs and approximately 11,695,680 IU of UMAN BIG have been sold worldwide between June 1995 and December 2007.
Maltese: BIG kif ukoll għal IMMUNOHBs (isem ta' ditta differenti iżda prodott identiku bl-istess daqs tal-pakketti u konċentrazzjonijiet, prodotti mill-istess siti ta' produzzjoni, bl-użu tal-istess proċess ta' produzzjoni), biex jindika li bejn Ġunju 1995 u Diċembru 2007 inbiegħu madwar 143,381,160
English: The study protocol was submitted to the RMS and all CMSs.
Maltese: Il-protokoll tal-istudju ġie ppreżentat lill-RMS u lis-CMSs kollha.
English: Specific neutralizing antibodies against the Hepatitis B virus are present at a concentration of not less than 180 IU/ml.
Maltese: Antikorpi newtralizzaturi speċifiċi kontra l-virus tal-epatite B huma preżenti f'konċentrazzjoni ta' mhux inqas minn 180 IU/ml.
English: Sweden
Maltese: Malta
English: The CHMP noted that UMAN BIG is manufactured from large pools of human plasma, through a consolidated and validated industrial process and that the conformity of UMAN BIG to Ph. Eur.
Maltese: BIG huwa prodott minn ġbir kbir ta' plażma umana, permezz ta' proċess industrijali konsolidat u konvalidat u li l-konformità ta' UMAN
English: A literature search on specific immunoglobulins for intramuscular administration has shown, in general, a satisfactory profile of tolerability and safety, even if mild to moderate adverse events have been observed.
Maltese: Tfittxija fil-letteratura fuq immunoglobulini speċifiċi għal amministrazzjoni ġol-muskoli, b'mod ġenerali wriet profil sodisfaċenti ta' tollerabilità u sigurtà, anke jekk ġew osservati avvenimenti avversi ħfief għal moderati.
English: The Applicant provided bibliographic data showing that the pharmacokinetics of UMAN BIG in the population in which the PK study was carried out is super-imposable to that of healthy volunteers; therefore the population of study KB 036, although representing a specific subset of patients, did not influence the results obtained.
Maltese: BIG fil-popolazzjoni li fiha sar l-istudju farmakokinetiku tista' toqgħod għal dik tal-voluntiera b'saħħithom; għalhekk ilpopolazzjoni tal-istudju KB 036, għalkemm tirrappreżenta sottogrupp speċifiku ta' pazjenti, ma influwenzatx ir-riżultati miksuba.
English: The objecting member state Greece raised a potentially serious risk to public health related to the design of the submitted PK study designed to support the initial application, since the population enrolled in the PK study represents a different patient population from the population intended for the use of UMAN BIG and because the dosage administered was different from the posology indicated in the SPC.
Maltese: Il-Greċja, l-Istat Membru li oġġezzjona, qajjem riskju potenzjalment gravi għas-saħħa pubblika relatat mal-mod kif inhu mfassal l-istudju farmakokinetiku ppreżentat sabiex jappoġġja l-applikazzjoni inizjali, billi l-popolazzjoni reklutata fl-istudju farmakokinetiku tirrappreżenta popolazzjoni ta' pazjenti differenti mill-popolazzjoni intenzjonata għall-użu ta' UMAN
English: The Applicant concluded that no new information on tolerability is available to suggest a modification of the safety profile of UMAN BIG.
Maltese: L-Applikant ikkonkluda li m'hemm l-ebda informazzjoni ġdida disponibbli dwar it-tollerabilità biex tiġi suġġerita modifika tal-profil ta' sigurtà ta' UMAN
English: Literature references show also that the pharmacokinetic profile of UMAN BIG is comparable to that of other intramuscular Hepatitis B immunoglobulin products.
Maltese: BIG huwa komparabbli għal dak ta' prodotti oħra ta' immunoglobulina għall-epatite B intramuskolari.
English: The application for UMAN BIG 180 IU/ml solution for injection was submitted through the Mutual Recognition Procedure, on the basis of the marketing authorisation granted by the RMS (Italy) on the 2nd of June 1979.
Maltese: BIG 180 IU/ml soluzzjoni injettabbli ppreżentata permezz tal-Proċedura ta' Rikonoxximent Reċiproku, fuq il-bażi tal-awtorizzazzjoni għattqegħid fis-suq u ngħatat mill-RMS (Italja) nhar it-2 ta' Ġunju 1979.
English: The Applicant submitted data from study PK KB-036, which evaluates the PK profile of Hepatitis B
Maltese: L-istudju farmakokinetiku KB-036 juri li l-antikorpi anti-HbsAg f'UMAN
English: More than 1,000 Italian newborns included in the studies (published between 1983 and 2001) received UMAN BIG and the dose regimen and protective threshold (10 mIU/ml) are consistent with the provisions of the current core SPC and proposed SPC.
Maltese: BIG u r-reġim tad-doża u l-limitu protettiv (10mlU/ml) huma konsistenti mad-dispożizzjonijiet tal-SPC ewlieni attwali u mal-SPC propost.
English: UMAN BIG 180 IU/ml
Maltese: BIG 180 UI/ml
English: The PK behaviour, especially in terms of half life of the anti HB antibodies and maintenance of a protective antibody level titre can be considered as an acceptable surrogate marker of efficacy.
Maltese: L-imġiba farmakokinetika, b'mod speċjali f'termini ta' half life talantikorpi kontra l-HB u ż-żamma ta' titolu (titre) ta' livell protettiv tal-antikorp, tista' titqies bħala markatur sostitut aċċettabbli tal-effikaċja.
English: The dose regimen and protective threshold were consistent with the current core SPC.
Maltese: Ir-reġim pożoloġiku u l-limitu protettiv kienu konsistenti mal-SPC ewlieni preżenti.
English: The PK KB-036 study demonstrates that the anti-HBsAg antibodies in UMAN BIG maintain the kinetic profile of the natural antibodies and that the entire production process does not affect their characteristics or the integrity of the immunoglobulin molecule and therefore does not alter the biological response.
Maltese: BIG iżommu l-profil kinetiku tal-antikorpi naturali u li l-proċess ta' produzzjoni kollu ma jaffettwax il-karatteristiċi tagħhom jew l-integrità tal-molekula tal-immunoglobulina u għalhekk ma jbiddilx ir-rispons bijoloġiku.
English: Based on the proof-of-principle applied to all immunoglobulins, the BPWP considered that submitting a single PK study is acceptable.
Maltese: Skont il-prova tal-prinċipju applikata għallimmunoglobulini kollha, il-BPWP ikkunsidra li s-sottomissjoni ta' studju farmakokinetiku wieħed hija aċċettabli.
English: The CHMP noted that an active pharmacovigilance system is in place in Italy since 1975 guaranteeing a strict control of the adverse events linked to medicinal products and that the Italian pharmacovigilance database does not contain a single suspected adverse reaction signal related to UMAN BIG, which is consistent with the statement of the Applicant of the safety of UMAN BIG.
Maltese: Is-CHMP innota li fl-Italja teżisti sistema ta' farmakoviġilanza attiva li ilha fis-seħħ sa mill-1975 li tiggarantixxi kontroll strett tal-avvenimenti avversi marbuta ma' prodotti mediċinali u li d-database ta' farmakoviġilanza Taljana ma fihiex sinjal wieħed ta' reazzjoni avversa suspettata relatata ma' UMAN
English: UMAN BIG contains glycine as the excipient, a natural amino acid and therefore not expected to cause any problems.
Maltese: BIG fih il-gliċina bħala s-sustanza mhux attiva, amminoaċidu naturali u għalhekk mhux mistenni li jikkawża xi problema.
English: Greece considered that a change in liver function is a common cause of altered drug pharmacokinetics and that the dosage in the PK study was much higher than that recommended in the relevant core SPC and proposed SPC.
Maltese: Il-Greċja kkunsidrat li bidla fil-funzjoni epatika hija kawża komuni ta' alterazzjonijiet tal-karatteristiċi farmakokinetiċi tal-mediċini u li d-dożaġġ flistudju farmakokinetiku kien ħafna ogħla minn dak rakkomandat mill-SPC ewlieni rilevanti u millSPC propost.