FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change in the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Following administration of Nimenrix there is a waning of serum bactericidal antibody titres against group A when using hSBA (see section 5.1).
Maltese: MenA meta jintuża l-hSBA (ara sezzjoni 5.1).
English: • received your first dose at age 6-14 months and could be at particular risk of infection caused by Neisseria meningitidis types W-135 and Y
Maltese: • irċevejtu l-ewwel doża tagħkom f'età ta' 6-14-il xahar u tistgħu tkunu f'riskju partikolari ta' infezzjoni kkawżata minn Neisseria meningitidis tipi W-135 u Y
English: Powder and solvent for solution for injection in ampoule
Maltese: Ż-ŻGĦAR EWLENIN AMPULLA BIS-SOLVENT
English: Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine against Neisseria meningitidis
Maltese: Rispons ta' rinforz għal individwi li qabel kienu tlaqqmu b'vaċċin konjuat tal-meningokokkus kontra Neisseria meningitides
English: Group Vaccine group Timing
Maltese: Grupp talvaċċin
English: Similar responses to groups A and C were observed after one or two doses (see section 5.1).
Maltese: Wara doża waħda jew tnejn ġew osservati risponsi simili għall-gruppi A u Ċ (ara sezzjoni 5.1).
English: A booster dose might be considered in individuals vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 or Y (see section 5.1).
Maltese: Maż-żmien ġie osservat tnaqqis fit-titres tal-antikorpi għall-gruppi A, C, W-135 u Y.
English: Imatinib Actavis is available as capsules (50, 100 and 400 mg) and tablets (100 and 400 mg).
Maltese: Imatinib Actavis jiġi bħala kapsuli (50, 100 u 400 mg) u pilloli (100 u 400 mg).
English: Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
Maltese: ema.europa.eu/medicines/human/EPAR/imatinib-actavis.
English: Imatinib Actavis is a ‘generic medicine'.
Maltese: Imatinib Actavis huwa ‘mediċina ġenerika'.
English: The active substance in Imatinib Actavis, imatinib, is a protein-tyrosine-kinase inhibitor.
Maltese: Is-sustanza attiva f'Imatinib Actavis, l-imatinib, hija inibitur tal-proteina tirosina kinażi.
English: Other information about Imatinib Actavis
Maltese: Informazzjoni oħra dwar Imatinib Actavis
English: Imatinib Actavis is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Maltese: Imatinib Actavis jintuża fil-kura ta' adulti bl-MD/MPD li kellhom arranġamenti mill-ġdid tal-ġene għar-riċettur tal-fattur tat-tkabbir derivat mill-pjastrini (PDGFR);
English: • advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Maltese: • sindromu avvanzat ipereosinofiliku (HES) jew lewkimja kronika eosinofilika (CEL), mard fejn leosinofili (tip ieħor ta' ċelloli tad-demm bojod) jibdew jikbru mingħajr kontroll.
English: Imatinib Actavis is used when the patients are ‘Philadelphia-chromosome positive' (Ph+).
Maltese: Imatinib Actavis jintuża meta l-pazjenti jkunu ‘pożittivi għall-kromożoma ta' Philadelphia' (Ph+).
English: Imatinib Actavis received a marketing authorisation valid throughout the EU for Imatinib Actavis on 17 April 2013.
Maltese: Imatinib Actavis irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-17 ta' April 2013.
English: This means that it blocks enzymes known as tyrosine kinases.
Maltese: Dan ifisser li din timblokka enzimi magħrufa bħala tirosina kinażi.
English: Imatinib Actavis is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Maltese: Imatinib Actavis jintuża għall-kura ta' adulti bl-HES jew bis-CEL li jkollhom arranġament mill-ġdid speċifiku ta' żewġ ġeni msejħa FIP1L1 u PDGFRα;
English: Imatinib Actavis is a cancer medicine that contains the active substance imatinib.
Maltese: Imatinib Actavis huwa mediċina kontra l-kanċer li fiha s-sustanza attiva imatinib.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Actavis.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użijiet awtorizzati bil-mediċina ta' referenza, Glivec, u ma għandhomx għalfejn jiġu ripetuti għal Imatinib Actavis.
English: • Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Maltese: • Ph+ lewkimja limfoblastika akuta (ALL), tip ta' kanċer fejn il-linfoċiti (tip ieħor ta' ċelloli tad-demm bojod) jirriproduċu ruħhom malajr ħafna.
English: Because Imatinib Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Imatinib Actavis huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Imatinib Actavis is also used in adults with Ph+ CML in blast crisis.
Maltese: Imatinib Actavis jintuża wkoll f'adulti li jkollhom Ph+ CML fil-fażi terminali.
English: Imatinib Actavis is used to treat adults with DFSP that cannot be removed with surgery, and in adults who cannot have surgery when the cancer has returned after treatment or has spread to other parts of the body.
Maltese: Imatinib Actavis jintuża għall-kura ta' adulti b'DFSP li ma jistax jitneħħa b'intervent kirurġiku, u f'adulti li ma jistgħux jagħmlu intervent kirurġiku meta l-kanċer ikun reġa' tfaċċa wara l-kura jew meta dan ikun infirex f'partijiet oħra tal-ġisem.
English: • dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Maltese: • dermatofibrosarkoma protuberans (DFSP), tip ta' kanċer (sarkoma) li fih iċ-ċelloli fit-tessut ta' taħt il-ġilda jinqasmu mingħajr kontroll.
English: As for all medicines, data on the use of Imatinib Actavis are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Imatinib Actavis hija ssorveljata kontinwament.
English: What are the benefits and risks of Imatinib Actavis?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Imatinib Actavis?
English: Imatinib Actavis is used with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Maltese: Imatinib Actavis jintuża flimkien ma' mediċini oħra kontra l-kanċer f'adulti u fi tfal li jkunu ġew dijanjostikati reċentement bil-Ph+ ALL.
English: This means that Imatinib Actavis contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Glivec.
Maltese: Dan ifisser li Imatinib Actavis fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-UE msejħa Glivec.
English: It is also used alone to treat adults with Ph+ ALL that has returned following previous treatment, or if other medicines are not working.
Maltese: Jintuża wkoll waħdu għall-kura ta' adulti bil-Ph+ ALL li reġgħet feġġet wara kura preċedenti, jew jekk mediċini oħra ma jkunux qed jaħdmu.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Imatinib Actavis has been shown to have comparable quality and to be bioequivalent to Glivec.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Imatinib Actavis wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Glivec.
English: How does Imatinib Actavis work?
Maltese: Kif jaħdem Imatinib Actavis?
English: Imatinib Actavis is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Maltese: Imatinib Actavis jingħata mill-ħalq ma' ikla u tazza ilma kbira biex jitnaqqas ir-riskju ta' irritazzjoni tal-istonku u tal-intestini.
English: How has Imatinib Actavis been studied?
Maltese: Kif ġie studjat Imatinib Actavis?
English: • chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
Maltese: • lewkimja mjelojde kronika (CML), kanċer taċ-ċelloli tad-demm bojod fejn il-granuloċiti (tip ta' ċelloli tad-demm bojod) jibdew jikbru mingħajr kontroll.
English: Pack of 1, 10 or 50.
Maltese: Pakkett ta' 1, 10 jew 50.
English: Multipack of 50 (5x10) (including blue box)
Maltese: Multiplu ta' 50 (5x10) (inkluż kaxxa blu)
English: OTHER Sanofi Pasteur Europe
Maltese: Sanofi Pasteur Europe
English: Sanofi Bulgaria EOOD Teл.
Maltese: Sanofi Bulgaria EOOD
English: 2D barcode carrying the unique identifier included.
Maltese: Bar code 2D jġorru l-identifikatur uniku inklużi.
English: Component of a multipack, cannot be sold separately.
Maltese: Komponent ta 'pakkett multiplu , ma jistax jinbiegħ separatament .
English: BATCH NUMBER Lot
Maltese: NUMRU TAL LOTT
English: Hexyon is available in pack containing 10 vials.
Maltese: Hexyon huwa disponibbli f'pakkett li fih 10 fjali.
English: N=322†† N=934 to
Maltese: N=322†† N=934 to N=249** N=123 to
English: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, France
Maltese: Sanofi Pasteur Europe, 14 Espace Henry Vallée, 69007 Lyon, Franza
English: Manufacturer: Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, France
Maltese: Sanofi Pasteur SA, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, Franza
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09 The immunogenicity of Hexyon in children over 24 months of age has not been studied in clinical trials.
Maltese: Vaċċini, vaċċini batterjali u virali kombinati, Kodiċi ATC: J07CA09 L-immunoġeniċità ta Hexyon fi tfal aktar minn 24 xahar ta 'età ma ġiex studjat fi provi kliniċi.
English: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, saccharose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment), and water for injections.
Maltese: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, sakkarosju, aċidi amminiċi essenzjali li jinkludu L-phenylalanine, sodium hydroxide u/jew acetic acid u/jew hydrochloric acid (għallaġġustament tal-pH), u ilma għall-injezzjonijiet.
English: 10 vials (0.5 ml)
Maltese: Doża 1 (0.5 ml)
English: EU/1/13/829/002 EU/1/13/829/003 EU/1/13/829/004 EU/1/13/829/005 EU/1/13/829/006 EU/1/13/829/007 EU/1/13/829/008
Maltese: EU/1/13/829/005 EU/1/13/829/006 EU/1/13/829/007 EU/1/13/829/008
English: Multipack: 50 (5 packs of 10) pre-filled syringes (0.5ml) without needle.
Maltese: Pakkett multiplu : 50 (5 pakketti ta ' 10) siringi mimlijin lesti (0.5 ml) mingħajr labra.
English: The safety of Hexyon in children over 24 months of age has not been studied in clinical trials.
Maltese: Is-sigurtà ta Hexyon fi tfal aktar minn 24 xahar ta 'età ma ġiex studjat fi provi kliniċi.
English: Pack of 10.
Maltese: Pakkett ta '10 .
English: Table 3: Seroprotection ratesa at the age of 4.5 years old after vaccination with Hexyon Antibody Thresholds
Maltese: Tabella 3: Rati ta' protezzjoni fis-serum a fl-età ta' 4.5 snin wara vaċċinazzjoni b'Hexyon
English: Marketing Authorisation Holder:
Maltese: Barra minn hekk:
English: Sanofi Pasteur, Parc Industriel d'Incarville, 27100 Val de Reuil, France
Maltese: Sanofi Pasteur SA, Parc Industriel d'Incarville, 27100
English: The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexyon (N=148) at 2, 4, 6 months of age.
Maltese: Ir-rispons immuni għal Hib (PRP) u l-antiġeni tal-pertussis (PT u FHA) kienu evalwati wara 2 dożi fi subsett ta ' individwi li ngħataw Hexyon (N = 148) fi 2, 4 , 6 xhur ta' età.
English: Hexyon in vials EU/1/13/829/001
Maltese: Hexyon f'kunjetti EU/1/13/829/001
English: Data on concomitant administration of Hexyon with a meningococcal C conjugate vaccine or a meningococcal group A, C, W-135 and Y conjugate vaccine have shown no clinically relevant interference in the antibody response to each of the antigens.
Maltese: Data dwar l-amministrazzjoni konkomitanti ta ' Hexacima ma' vaċċin konjugat ta' meningokokkus C jew grupp meningokokkali A, C, W-135 u Y vaċċin konjugat ma uriet l-ebda interferenza klinikament rilevanti fir-rispons ta' antikorpi għall kull wieħed mill- antiġeni.
English: Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al
Maltese: Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al
English: Anti-diphtheria (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) (≥ 0.1 IU/ml) Anti-PTe (≥ 8 EU/ml) Anti-FHAe (≥ 8 EU/ml) Anti-HBs (≥ 10 mIU/ml) Anti-Polio type 1 (≥ 8 (1/dilution))
Maltese: (≥ 8 EU/ml) Anti-FHAe (≥ 8 EU/ml) Anti-HBs (≥ 10 mIU/ml) Anti-Poljo tip 1 (≥ 8 (1/dilution))
English: Pack of 10 for multipack (without blue box)
Maltese: Multiplu ta' 10 (inkluż kaxxa blu)
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Maltese: Il-vaċċin jista 'jkun fiha traċċi ta' glutaraldehyde formaldehyde, neomycin, streptomycin u polymyxin B.
English: Multipack of 50 (5 packs of 10) pre-filled syringes without needle.
Maltese: Pakkett multiplu ta '50 (5 pakketti ta' 10) siringi mimlijin minn qabel mingħajr labra .
English: The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Maltese: effettività tal-vaċċin kienet ta' 96.7% għas-serje primarja sħiħa, u 98.5% għal doża buster
English: Hexyon in pre-filled syringes EU/1/13/829/002
Maltese: Hexyon f'siringa mimlija għal-lest EU/1/13/829/002
English: Hexyon is available in multipack comprising 5 cartons, each containing 10 pre-filled syringes without attached needle.
Maltese: Hexyon huwa disponibbli fil multiplu b'5 kartuni , kull wieħed ikun fih 10 siringi mimlijin għal-lest mingħajr labra mwaħħla .
English: Hexyon is available in pack containing 1,10 or 50 pre-filled syringes without attached needle.
Maltese: Hexyon huwa disponibbli f'pakkett li fih 1, 10 jew 50 siringi mimlija lesti mingħajr labra mwaħħla.
English: Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexyon against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal).
Maltese: L-effikaċja tal-vaċċin tal-antiġeni tal-pertussi aċellulari (aP) li hemm f' Hexyon kontra l-aktar pertussi tipika severa mfissra mill-WHO (≥ 21 jum ta' sogħla parossimali) hi dokumentata fi studju każwali u double-blind fost trabi b'doża primarja ta' 3 permezz tal-vaċċin DTaP f'pajjiż endemiku (Senegal).
English: 1 pre-filled syringe (0.5 ml) without needle 10 pre-filled syringes (0.5 ml) without needle 50 pre-filled syringes (0.5 ml) without needle 1 pre-filled syringe (0.5 ml) with 1 needle 10 pre-filled syringes (0.5 ml) with 10 needles 1 pre-filled syringe (0.5 ml) with 2 needles 10 pre-filled syringes (0.5 ml) with 20 needles
Maltese: 10 siringi mimlija lesti mingħajr labra (0.5 ml) 50 siringi mimlija lesti mingħajr labra (0.5 ml)
English: 0.5 ml suspension in vial (type I glass) with a stopper (halobutyl).
Maltese: 0.5 ml suspensjoni (ħġieġ tip I) b'tapp (halobutyl)
English: Hexyon is provided as a suspension for injection in vial (0.5 ml).
Maltese: Hexyon jiġi bħala suspensjoni għall-injezzjoni fi kunjett (0.5 ml).
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Hexyon.
Maltese: Storja ta' aċċessjonijiet bid-deni, storja familjari ta' konvulżjonijiet jew is-Sindromu ta' Mewt f'Daqqa fi Trabi (SIDS - Sudden Infant Death Syndrome) ma jikkostitwixxux kontraindikazzjoni għall-użu ta' Hexyon.
English: EU/1/13/829/008 EU/1/13/829/009
Maltese: EU/1/13/829/002 EU/1/13/829/003 EU/1/13/829/004
English: Hexyon can be considered for the booster.
Maltese: Hexyon jista jkun ikkunsidrat għal dan il buster.
English: Hexyon does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins.
Maltese: Hexyon ma jipproteġix kontra mard infettiv ikkawżat minn tipi oħra ta' Haemophilus influenzae jew kontra meninġite li ġejja minn oriġini oħra.
English: Hexyon suspension for injection in pre-filled syringe Hexyon suspension for injection
Maltese: Hexyon suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Hexyon suspensjoni għall-injezzjoni
English: The long term capability of the acellular pertussis (aP) antigens contained in Hexyon to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule.
Maltese: Il-kapaċità fuq perjodu ta' żmien twil tal-antiġeni ta' pertussi aċellulari (aP) li hemm f'Hexyon Hexyon biex titnaqqas l-inċidenza ta' pertussi u jiġi kkontrollat il-mard ta' pertussi fit-tfulija ntweriet f'sorveljanza nazzjonali ta' 10 snin fuq il-marda ta' pertussi fl-Iżvezja bil-vaċċin pentavalenti DTaP-IPV/Hib, bi skeda ta' 3,5,12 xhur.
English: • Hexyon should not be mixed with other medicinal products.
Maltese: • Hexyon m'għandux jitħallat ma' prodotti mediċinali oħrajn.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose1 (0.5 ml) contains:
Maltese: Doża waħda1 (0.5 ml) fiha:
English: Hexyon is available in pack containing 1 or 10 pre-filled syringes with 1 separate needle.
Maltese: Hexyon huwa disponibbli f'pakkett li fih 1 jew 10 siringi mimlija lesti b'labra 1 separata.
English: Hexyon is a whitish, cloudy suspension.
Maltese: Hexyon hija suspensjoni bajdanija u mdennsa.
English: There may be a clinically relevant interference in the antibody response of Hexyon and a varicella vaccine and these vaccines should not be administered at the same time.
Maltese: Jista' jkun hemm interferenza klinikament rilevanti fir-rispons antikorporali ta' Hexyon u tilqim ta variċella u dawn il-vaċċini m'għandhomx jingħataw fl-istess żmien.
English: d- Potential adverse events (i.e. adverse events which have been reported with other vaccines containing one or more of the components or constituents of Hexyon and not directly with Hexyon)
Maltese: d- Każijiet avversi potenzjali (i.e. każijiet avversi li ġew rrappurtati b'vaċċini oħra li fihom wieħed jew aktar mill-komponenti jew kostitwenti ta' Hexyon u mhux direttament b'Hexyon)
English: Hexyon will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Maltese: Clostridium tetani, Bordetella pertussis, il-virus ta' epatite B, poljovirus jew Haemophilus influenzae tip b. Madankollu, jista' jkun mistenni li l-epatite D ser tiġi mxekkla mill-immunizzazzjoni peress li epatite D (ikkawżata mill-aġent delta) ma sseħħx fl-assenza ta' infezzjoni b'epatite B.
English: Serious allergic reactions are a rare possibility (may affect up to 1 in 1,000 people) after receiving this vaccine.
Maltese: Reazzjonijiet allerġiċi serji huma possibiltà rari (jistgħu jaffettwaw minn perusna 1 minn kull 1,000) wara it-teħid ta' din it- tilqima.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexyon or a vaccine containing the same components or constituents.
Maltese: Sensittività eċċessiva għas-sustanzi attivi, għal kwalunkwe wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1, għal traċċi ta` residwi (glutaraldehyde, formaldehyde, neomycin, streptomycin u polymyxin B), għal kull vaċċin ta' pertussi, jew wara l-għoti preċedenti ta Hexyon jew vaċċin li jkun fih l-istess komponenti jew kostitwenti.
English: IM
Maltese: L
English: 10 pre-filled syringes (0.5ml) without needle.
Maltese: 10 siringi mimlija lesti (0.5ml) mingħajr labra .
English: No data are available in older children (see sections 4.8 and 5.1)
Maltese: M'hemmx informazzjoni disponibbli fi tfal akbar (ara sezzjonijiet 4.8 u 5
English: Hexyon will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Maltese: Hexyon tingħata lit-tifel/tifla tiegħek minn tabib jew infermier li huma mħarrġa fl-użu ta' vaċċini u li huma mgħammra biex jittrattaw ma' kull reazzjoni allerġika severa mhux komuni għall-injezzjoni (ara sezzjoni 4 ‘Effetti sekondarji possibbli).
English: • Hexyon must be administered intramuscularly.
Maltese: • Hexyon għandu jingħata ġol-muskoli.
English: Other medicines or vaccines and Hexyon
Maltese: Mediċini jew vaċċini oħra u Hexyon
English: Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Maltese: Hexyon (DTaP-IPV-HB-Hib) hu indikat għal trabi u tfal żgħar minn sitt ġimgħat għal tilqim primarju u bħala buster kontra d-difterite, it-tetnu, il-pertussi, epatite B, poljomelite u mard invażiv ikkawżat minn
English: Hexyon is available in pack containing 1 or 10 pre-filled syringes with 2 separate needles.
Maltese: Hexyon huwa disponibbli f'pakkett li fih 1 jew 10 siringi mimlija lesti b'2 labriet separati.
English: Anti-diphtheria (≥ 0.01 IU/ml) Anti-tetanus (≥ 0.01 IU/ml) Anti PT (Seroconversion‡‡) (Vaccine response§) Anti FHA (Seroconversion‡‡) (Vaccine response§)
Maltese: Antidifterite (≥ 0.01 IU/ml) Antitetnu
English: Hexyon may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine.
Maltese: Hexyon jista jintuża bħala buster f'dawk in-nies li qabel ingħataw tilqim ieħor hexavalenti jew tilqim pentavalenti DTaP-IPV/Hib assoċjat ma tilqim ta epatite B monovalenti.
English: Table 2: Seroprotection/Seroconversion rates* one month after booster vaccination with Hexyon Antibody Thresholds
Maltese: Tabella 2: Rati ta' Seroprotezzjoni/Serokonverżjoni* xahar wara tilqim buster b' Hexyon
English: Hexyon helps to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious diseases caused by Haemophilus influenzae type b. Hexyon is given to children from six weeks of age.
Maltese: Hexyon jgħin biex jipproteġi kontra d-difterite, it-tetnu, il-pertussi, l-epatite B, il-poljomelite u mard serju kkawżat minn Haemophilus influenzae tip b. Hexyon jingħata lit-tfal minn 6 ġimgħat.
English: • Hexyon will not protect against hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E.
Maltese: • Hexyon mhux ser jipproteġi kontra l-infezzjoni ta' epatite kkawżata minn aġenti oħrajn bħal epatite A, epatite Ċ u l-epatite E .
English: Otherwise, post-vaccination antibody concentration should be ≥ pre immunisation level.
Maltese: Inkella, il-konċentrazzjoni ta 'antikorpi wara t-tilqima għandhom jiġu ≥ livell pre- immunizzazzjoni.