FrancophonIA/ELRC3.0 huggingface dataset:
English: SN: {number} [serial number]
Maltese: {numru} [numru tas-serje]
English: 1 ml contains:
Maltese: 1 ml fih:
English: MedDRA System Organ Class
Maltese: Sistema tal-klassifika talorgani MedDRA
English: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4 IgA content ≤ 6,000 micrograms/ml
Maltese: 59 % IgG1, 35 % IgG2, 3 % IgG3, 3 % IgG4
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/600/001
Maltese: EU/1/09/600/001
English: ATC code: J06BB04
Maltese: J06BB04
English: Nederland Infarama BVBA Stationsstraat 27
Maltese: Infarama BVBA Stationsstraat 27
English: Rodel Ltd
Maltese: Malta Rodel Ltd
English: A failure rate of 0 % was also found for the facultative extension phase (week 24) (95 % CI: [0, 20.6 %])
Maltese: Rata ta' falliment ta' 0% instabet ukoll fil-fażi ta' estensjoni fakultattiva (ġimgħa 24) (95% CI: [0, 20.6%])
English: Aquilant Pharmaceuticals 21 Fonthill Business Park Fonthill Road Clondalkin
Maltese: Aquilant Pharmaceuticals 21 Fonthill Business Park
English: 61A Drumul Plaiul Sarului Street, Room 5 013982 Bucharest, District 1 - RO Tel: + 40 743 207 205
Maltese: Besmax Pharmaceutical Distribution S.R.L. 61A Drumul Plaiul Sarului Street, Room 5 013982 Bucharest, District 1 - RO Tel: + 40 743 207 205
English: The maximum IgA content is 6,000 micrograms/ml.
Maltese: Kontenut IgA ≤ 6,000 mikrogramma/ml
English: D-63303 Dreieich Germany
Maltese: D-63303 Dreieich
English: INFORMATION IN BRAILLE Zutectra 500 IU
Maltese: Informazzjoni għall-utent Zutectra 500
English: Via Leonardo da Vinci 43 I-20090 Trezzano sul Naviglio Tel: + 39 02 4844 2951
Maltese: I-20090 Trezzano sul Naviglio Tel: + 39 02 4844 2951
English: CZ-10600 Praha 10 Tel: + 420 2 7265 4004
Maltese: Praha 10 Tel: + 420 2 7265 4004
English: A-1050 Wien Tel: + 43 1 545 15 61-0
Maltese: Wien Tel: + 43 1 545 15 61-0
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Immune system disorders
Maltese: Disturbi fis-sistema immuni
English: Nobipharm Sp. Z.o.o.
Maltese: Sp. Z.o.o.
English: True hypersensitivity reactions are rare.
Maltese: Reazzjonijiet reali ta' sensittività eċċessiva huma rari.
English: All patients used antiviral medicine.
Maltese: Il-pazjenti kollha użaw mediċina antivirali.
English: Transmissible agents
Maltese: Aġenti trasmissibbli
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu/.
English: The maximum immunoglobulin A (IgA) content is 6,000 micrograms/ml.
Maltese: Il-kontenut massimu ta' immunoglobulina A (IgA) hu ta' 6,000 mikrogramma/ml.
English: Oropharyngeal pain
Maltese: Spażmi muskolari
English: IgG and IgG-complexes are broken down in the reticuloendothelial system.
Maltese: IgG u kumplessi IgG jitkissru fiċ-ċelluli tas-sistema retikuloendoteljali.
English: Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tél: 00800 98832872
Maltese: D-63303 Dreieich Tél: 00800 98832872
English: Hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
Maltese: Immunoglobulina tal-epatite B primarjament fiha immunoglobulina G (IgG) b'kontenut speċifikament għoli ta' antikorpi kontra antiġen tas-superfiċe tal-virus ta' epatite B (HBs).
English: Zutectra contains 150 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG).
Maltese: IU/ml. Zutectra fih 150 mg/ml ta' proteina tal-plażma umana, li minnha, mill-inqas 96% hi immunoglobulina G (IgG).
English: Distribution of IgG subclasses: IgG1:
Maltese: Distribuzzjoni tas-sottoklassij ta' IgG:
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 għall-antiġeni eritroċiti, eż. A, B, D, tista' tfixkel xi testijiet seroloġiċi għall-antikorpi taċ-ċelluli ħomor, pereżempju t-test tal-antiglobulina (it-test ta' Coomb).
English: In very rare cases human normal immunoglobulins may cause a serious allergic reaction.
Maltese: F'każijiet rari ħafna immunoglobulini normali umani jistgħu jikkawżaw reazzjoni allerġika serja.
English: Luxembourg/Luxemburg Biotest AG
Maltese: Latvija Biotest AG
English: BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT LOTT
English: The following adverse reactions have been reported in the context of 4,810 subcutaneous applications of Zutectra during four completed clinical trials and 1,006 applications during a non-interventional post marketing safety study (PASS).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrappurtati fil-kuntest ta' 4,810 użu taħt il-ġilda ta' Zutectra matul erba' provi kliniċi kompluti u 1,006 applikazzjoni waqt studju mingħajr interventi ta' wara t-tqegħid fis-suq (PASS).
English: Using the Clopper Pearson method, the failure rate after 18 weeks was 0 % for patients of the ITT set (95 % CI: [0, 14.8 %]).
Maltese: Bl-użu tal-metodu Clopper Pearson, ir-rata ta' falliment wara 18-il ġimgħa kienet ta' 0% għal pazjenti tal-sett ta' ITT (95% CI:
English: Musculosceletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: Pruritus, rash
Maltese: Ħakk, raxx
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Maltese: {numru} [numru tar-rimborż nazzjonali jew numru nazzjonali tal-identifikazzjoni ieħor għallprodott mediċinali]
English: Slovenija MEDIS, d.o.o.
Maltese: Slovenija MEDIS, d.o.o. Brnčičeva 1,
English: Biotest Austria GmbH Einsiedlergasse 58
Maltese: Einsiedlergasse 58
English: Frequency per injection has been evaluated using the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Maltese: Il-frekwenza għal kull injezzjoni kienet evalwata skont il-kriterji li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Suomi/Finland Unimedic Pharma AB Box 6216
Maltese: Suomi/Finland Unimedic Pharma AB
English: OTHER
Maltese: IU
English: The mean anti-HBs serum level before switching was 393 ± 139 IU/l.
Maltese: Il-livell medju ta' anti-HBs serum qabel ma t-tip ta' mediċina nbidel kien ta' 393±139 IU/l.
English: IgG subclass distribution:
Maltese: Distribuzzjoni tas-sottoklassijiet ta' IgG:
English: Zutectra must be brought to room temperature (approx. 23°C-27°C) before use.
Maltese: Zutectra għandu jinġieb għal temperatura ambjentali (madwar 23°C-27°C) qabel l-użu.
English: ES-08960 Sant Just Desvern Barcelona Tel: + 34 935 952 661
Maltese: ES-08960 Sant Just Desvern Barcelona
English: With other human immunoglobulin preparations the following additional symptoms have been reported: chills headache dizziness fever vomiting mild allergic reactions nausea (urge to vomit) joint pain low blood pressure moderate low back pain injection site reactions: swelling, soreness, redness, hardening of the skin, local heat, itching, bruising and rash.
Maltese: Bi preparazzjonijiet oħrajn ta' immunoglobulina umana, is-sintomi addizzjonali li ġejjin kienu rrappurtati: tertir ta' bard uġigħ ta' ras sturdament deni rimettar reazzjonijiet allerġiċi ħfief dardir (tkun trid tirremetti) uġigħ fil-ġogi pressjoni tad-demm baxxa uġigħ moderat fin-naħa t'isfel tad-dahar reazzjonijiet fis-sit tal-injezzjoni: nefħa, uġigħ, ħmura, ebusija tal-ġilda, sħana lokali, ħakk, tbenġil u raxx.
English: * single case reports Adverse reactions observed with other human immunoglobulin preparations
Maltese: * rapporti ta' każijiet waħdiet Reazzjonijiet avversi osservati bi preparazzjonijiet oħrajn ta' immunoglobulini umani
English: Kolarova 7, 10000 Zagreb T: +385 1 2303 446
Maltese: Zagreb T: +385 1 2303 446
English: Pharmacotherapeutic group: Immune sera and immunoglobulins, Specific immunoglobulins, Hepatitis B immunoglobulin
Maltese: Sera immuni u immunoglobulini, Immunoglobulini speċifiċi, Immunoglobulin ta' Epatite B
English: Injection
Maltese: infezzjonijiet.
English: At the time of transplantation 21 patients (42.9%) were tested positive for HDV, patients with a positive HIV or HCV test were excluded from study participation.
Maltese: Fil-ħin tattrapjant, 21 pazjent (42.9%) ġew ittestjati pożittivi għal HDV, pazjenti b'test pożittiv għall-HIV jew HCV ġew esklużi mill-parteċipazzjoni fl-istudju.
English: Lot
Maltese: LOTT
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19 virus (causative agent of Ringel rubella).
Maltese: Il-miżuri li jittieħdu jista' jkollhom effett limitat kontra viruses non-enveloped bħal parvovirus B19 (aġent kawżattivi ta' rubella ta' Ringel).
English: Prepare the Zutectra syringe:
Maltese: Ipprepara s-siringa b'Zutectra:
English: Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients.
Maltese: Livelli ta' antikorpi ta' > 100 IU/l għandhom jinżammu f'pazjenti negattivi għal HBsAg u
English: In total, 42/61 patients (68.9 %) used antiviral medication and 19 patients received monotherapy with Zutectra during this study.
Maltese: B'kollox 42/61 pazjent (68.9%) użaw mediċina antivirali u 19-il pazjent irċivew monoterapija b'Zutectra waqt dan l-istudju.
English: What Zutectra is
Maltese: Tużax Zutectra.
English: Human hepatitis B immunoglobulin
Maltese: Immunoglobulina tal-epatite B umana
English: Patients must be monitored for serum anti-HBs antibody levels regularly.
Maltese: Il-pazjenti jridu jiġu ssorveljati għal-livelli fis-serum tal-antikorpi anti-HBs regolarment.
English: The weekly subcutaneous dose was 500 IU for patients with bodyweight < 75 kg (a dose increase to 1000 IU was allowed, if medically required to maintain a safety level of > 100 IU) and 1000 IU for patients with bodyweight ≥ 75 kg. 2 patients received a higher and 2 patients received a lower dose than recommended by the weight based dosing regimen.
Maltese: IU għal pazjenti b'piż tal-ġisem ta' < 75 kg (żieda fid-doża sa 1,000 IU kienet permessa, jekk medikament meħtieġa, biex iżżomm livell ta' sigurtà ta' > 100 IU) u 1,000 IU għal pazjenti b'piż talġisem ta' ≥ 75 kg. 2 pazjenti ngħataw doża ogħla u 2 pazjenti ngħataw doża iktar baxxa minn dik irrakkomandata mill-kors tad-dożaġġ ibbażat fuq il-piż.
English: Human protein 150 mg of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU.
Maltese: 150 mg ta' proteina umana li minnha mill-inqas 96 % tkun IgG, b'kontenut ta' antikorpi għal antiġen tas-superfiċje tal-virus ta' epatite B (HBs) ta' 500
English: Other medicines and Zutectra
Maltese: Mediċini oħra u Zutectra
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għal immunoglobulini umani.
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 the viral safety.
Maltese: Hemm esperjenza klinika inkoraġġanti dwar in-nuqqas ta' trasmissjoni ta' epatite A jew ta' parvovirus B19 permezz tal-immunoglobulini, u hu ssoponut ukoll li l-kontenut tal-antikorpi jagħti kontribuzzjoni importanti lis-sigurtà virali.
English: - Remove the protective cap from the syringe.
Maltese: - Neħħi l-għatu protettiv minn fuq is-siringa.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Maltese: 150 mg/ml ta' proteina umana li minnha mill-inqas 96 % tkun IgG, b'kontenut ta' antikorpi għal antiġen tas-superfiċje tal-virus ta' epatite B (HBs) ta' 500
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Maltese: Il-miżuri li jittieħdu jista' jkollhom effett limitat kontra viruses non-enveloped bħal parvovirus B19.
English: The non-interventional post authorization safety study (PASS 978) enrolled 61 adult patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure.
Maltese: Fl-istudju tas-sigurtà mingħajr interventi ta' wara l-awtorizzazzjoni (PASS 978) ġew irreġistrati 61 pazjent adult ≥ 6 xhur wara t-trapjant tal-fwied għal insuffiċjenza tal-fwied minħabba l-epatite B.
English: Information on the starting material of Zutectra and the possibility of transmission of infectious agents:
Maltese: Informazzjoni dwar il-materjal tal-bidu ta' Zutectra u l-possibbiltà ta' trasmissjoni ta' orġaniżmi infettivi:
English: 49 patients received subcutaneous injections of Zutectra of 500 IU (1 mL) or 1,000 IU (2 mL) (dose adaptation in exceptional cases up to 1,500 IU) per week or fortnightly according to serum anti-HBs trough levels.
Maltese: IU (1 mL) jew 1,000 IU (2 mL) (adattament tad-doża f'każijiet eċċezzjonali sa 1,500 IU) kull ġimgħa jew kull ħmistax skont il-livelli minimi ta' anti-HBs fis-serum.
English: One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih 1 ml ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ ta' Tip I) b'tapp (bromobutyl) u għatu tat-tarf (lastku tal-bromobutyl).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Biotest Pharma GmbH
Maltese: FIS-SUQ Biotest Pharma GmbH
English: Serum antiHBs trough levels of 100 IU/l and higher (primary efficacy endpoint) were maintained for all patients during the 18 to 24 week trial period.
Maltese: L-inqas livelli anti-HBs fis-serum ta' 100 IU/l u ogħla (mira primarja tal-effikaċja) inżammu għall-pazjenti kollha matul il-perijodu tal-prova ta' minn 18 sa 24 ġimgħa.
English: The > 100 IU/l safety margin is the generally accepted level of effective prevention against HBV re-infection in liver transplant patients at risk.
Maltese: Il-marġni tas-sigurtà ta' 100 IU/l hu l-livell ġeneralment aċċettat ta' prevenzjoni effettiva kontra infezzjoni mill-ġdid bl-HBV f'pazjenti li kellhom trapjant tal-fwied li qegħdin f'riskju.
English: With normal immunoglobulins adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Maltese: B'immunoglobulini normali, reazzjonijiet avversi bħal tertir ta' bard, uġigħ ta' ras, deni, rimettar, reazzjonijiet allerġiċi, nawseja, artralġja, pressjoni tad-demm baxxa u wġigħ moderat fin-naħa t'isfel tad-dahar, jistgħu jseħħu kult ant.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: General information:
Maltese: Id-dirgħajn:
English: D-63303 Dreieich Tél/Tel: + 49 6103 801-0
Maltese: D-63303 Dreieich Sími: + 49 6103 801-0
English: Nasopharyngitis
Maltese: Il-Ġermanja
English: The active substance is human hepatitis B immunoglobulin 500 IU/ml.
Maltese: - Is-sustanza attiva hi immunoglobulina tal-epatite B umana 500
English: Glycine
Maltese: SIRINGA
English: During the 48-weeks treatment phase constant serum HBs antibody concentrations ≥ 100 IU/l were measured in all patients at all assessments with mean values of 312.0 ± 103.5 IU/l at the end of the treatment period.
Maltese: Matul il-perijodu ta' kura ta' 48 ġimgħa konċentrazzjonijiet ta' antikorpi ta' HBs fis-serum f'fażi kostanti ġew imkejla fil-pazjenti kollha fl-evalwazzjonijiet kollha b'valuri medji ta' 312.0 ± 103.5
English: Infections and infestations
Maltese: Infezzjonijiet u infestazzjonijiet Nażofarinġite
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 jiġu evitati infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l-għażla tad-donaturi, screening ta' donazzjonijiet individwali u ta' pools tal-plażma għal markaturi speċifiċi ta' infezzjoni u l-inklużjoni ta' miżuri effettivi fil-proċess tal-manifattura għall-inattivazzjoni/tneħħija ta' viruses.
English: For safety information with respect to transmissible agents, see section 4.4.
Maltese: Għal informazzjoni dwar is-sigurtà fir-rigward ta' mediċini trasmissibbli, ara sezzjoni 4.4.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Uġigħ ta' ras
English: Unimedic Pharma AB Box 6216
Maltese: Box 6216
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: One non-serious adverse event was reported to be related to Zutectra (injection site haematoma).
Maltese: Avveniment avvers wieħed mhux serju ieħor ġie rrappurtat li hu relatat ma' Zutectra (ematoma fis-sit tal-injezzjoni).
English: Serum anti-HBs antibody levels should be measured at least every 2-4 weeks and at the discretion of the physician in charge for at least half a year.
Maltese: antikorpi anti-HBs fis-serum għandhom jitkejlu talinqas kull 2-4 ġimgħat u fid-diskrezzjoni tat-tabib responsabbli għal mill-inqas sitt xhur.
English: Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure.
Maltese: Prevenzjoni ta' infezzjoni mill-ġdid mill-virus tal-epatite B (HBV) f'pazjenti adulti negattivi għal HBsAg u HBV-DNA mill-inqas ġimgħa wara trapjant tal-fwied għal insuffiċjenza tal-fwied ikkaġunata minn epatite B.
English: Avoid surgical scars.
Maltese: Evita ċikatriċi ta' xi operazzjoni.
English: No clinical signs of a hepatitis B re-infection were observed and no patient was tested HBsAg positive or HBV-DNA positive during the study which confirms that effective protection against Hepatitis B virus re-infection was provided by subcutaneous administration of Zutectra as part of the combination treatment with HBV virostatic therapy 8 - 18 days after orthotopic liver transplantation.
Maltese: Ma ġew osservati l-ebda sinjali kliniċi ta' infezzjoni mill-ġdid bl-epatite B u l-ebda pazjent ma ttestja pożittiv għal HBsAg jew pożittiv għal HBV-DNA matul l-istudju, u dan jikkonferma li protezzjoni effettiva kontra infezzjoni mill-ġdid bil-virus tal-Epatite B ġiet ipprovduta mill-għoti taħt il-ġilda ta' Zutectra bħala parti kura kombinata b'terapija virostatika kontra l-HBV 8 - 18-il jum wara trapjant ortotopiku tal-fwied.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: PT-1050 139 Lisboa
Maltese: A-1050
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Glycine
English: The objective of the open, prospective, single-arm clinical trial was the investigation of efficacy and safety of Zutectra for prevention of hepatitis B virus (HBV) re-infection ≥ one week after orthotopic liver transplantation in HBsAg and HBV-DNA negative patients.
Maltese: L-għan tal-prova klinika miftuħa, prospettiva, b'parti waħda, kien l-investigazzjoni tal-effikaċja u ssigurtà ta' Zutectra għall-prevenzjoni ta' infezzjoni mill-ġdid bil-virus (HBV) epatite B ≥ ġimgħa waħda wara trapjant ortotopiku tal-fwied f'pazjenti negattivi għal HBsAg u HBV-DNA.
English: 5 pre-filled syringes
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Palpitations, cardiac discomfort Rare*
Maltese: Palpitazzjonijiet, skonfort filqalb
English: Local reactions at injection sites Swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Maltese: Nefħa, dulur, ħmura, ebusija, sħana lokali, ħakk, tbenġil u raxx.
English: Store and transport refrigerated (2°C-8°C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2°C-8°C).
English: Zutectra contains antibodies against the hepatitis B virus which are the body's own defensive substances to protect you from hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus.
Maltese: Zutectra fih antikorpi kontra l-virus tal-epatite B li huma s-sustanzi difensivi tal-ġisem stess biex jipproteġuk mill-epatite B.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwisti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad
English: The 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: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
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 virus (HAV).
Maltese: virus) u virus tal-epatite Ċ (HCV-hepatitis C Virus) , u għall-virus non-enveloped tal-epatite A
English: In HBV-DNA negative adults at least one week after liver transplantation subcutaneous injections of Zutectra per week or fortnightly according to serum anti-HBs trough levels.
Maltese: F'adulti negattivi għal HBV-DNA mill-inqas ġimgħa wara t-trapjant tal-fwied, injezzjonijiet taħt ilġilda ta' Zutectra kull ġimgħa jew kull ħmistax skont il-livelli minimi ta' anti-HBs fis-serum.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Zutectra
English: Serum HBs antibody concentrations above the minimum safety trough level of >100 IU/L were measured in all patients at all timepoints independent of the type of administration (investigator, caregiver or self-injection), the dose regimen (500 IU, 1000 IU, 1500 IU) or the treatment intervals.
Maltese: Konċentrazzjonijiet ta' antikorp Hbs fis-serum 'il fuq mil-livell minimu tas-sigurtà ta' > 100 IU/L tkejlu fil-pazjenti kollha fil-punti ta' żmien kollha b'mod indipendenti mit-tip ta' għoti (investigatur, il-persuna li tieħu ħsieb il-pazjent jew injezzjoni li tingħata mill-pazjent innifsu), il-kors tad-doża (500
English: Common (may affect up to 1 in 10 people): - injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema).
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 f'10 persuni): - reazzjonijiet fis-sit tal-injezzjoni: uġigħ, urtikarja fis-sit tal-injezzjoni, ematoma (id-demm jinġemgħa fit-tessut ta' taħt il-ġilda), ħmura tal-ġilda (eritema).
English: NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe
Maltese: Id-doża tista' tiġi determinata individwalment u adattata minn 500
English: Name and address of the manufacturer of the biological active substance
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva
English: Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Τηλ: + 49 6103 801-0
Maltese: D-63303 Dreieich Τηλ: + 49 6103 801-0
English: Norge
Maltese: Deutschland