FrancophonIA/ELRC3.0 huggingface dataset:
English: Insulin (pre-filled pens and cartridges): insulin aspart; insulin bovine; insulin degludec; insulin degludec, insulin aspart; insulin degludec, liraglutide; insulin detemir; insulin glargine; insulin glulisine; insulin human (rDNA); insulin human, insulin isophane; insulin lispro; insulin porcinePotential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia (EPITT no 18893)
Maltese: Insulina (pinen u skartoċċi mimlija għal-lest): insulina aspart; insulina bovine; insulina degludec; insulina degludec, insulina aspart; insulina degludec, liraglutide; insulina detemir; insulina glargine; insulina glulisine; insulina umana (rDNA); insulina umana, insulina isophane; insulina lispro; insulina porcine - Riskju miżjud potenzjali ta' żball ta' medikazzjoni assoċjat ma' tislit tal-insulina minn pinen u skartoċċi mimlija għal-lest, li jwassal għal disgliċemija (EPITT nru 18893)
English: Adopted at the 27-30 November 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn is-27-30 ta' Novembru 2017
English: Frequency ‘not known': hypersensitivity; angioedema; urticaria
Maltese: Frekwenza “mhux magħruf”: sensittività eċċessiva; anġjoedema; urtikarja
English: Allergic reactions included angioedema and urticaria; serious reactions have occurred.
Maltese: Ir-reazzjonijiet allerġiċi inkludew anġjoedema u urtikarja; seħħew reazzjonijiet serji.
English: Other side effects which have been observed with XELJANZ are listed below.
Maltese: Effetti sekondarji oħrajn li ġew osservati b'XELJANZ huma elenkati hawn taħt.
English: Standard (100 units/mL) and lower (< 100 units/mL) strength insulin products The text to be adapted to individual products is in bold.
Maltese: Prodotti tal-insulina ta' qawwa standard (100 unità/mL) u aktar baxxa (< 100 unità/mL)
English: Special precautions for disposal and other handling The following text and any related package leaflet text should be removed: ‘If the <pen / infusion pump> malfunctions (see instructions for using the pen / infusion pump), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.'
Maltese: It-test li ġej u kwalunkwe test tal-fuljett ta' tagħrif relatat għandu jitneħħa: “Jekk il-<pinna / pompa ta' infużjoni> ma taħdimx tajjeb (ara l-istruzzjonijiet kif tuża l-pinna / pompa ta' infużjoni), issoluzzjoni tista' tinġibed mill-iskartoċċ għal ġo siringa (adatta għall-insulina b'100 unità/mL) u tiġi injettata.
English: Not known (frequency cannot be estimated from the available data): hives (itchy, bumpy rash)
Maltese: Mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli): ħorriqija (raxx bil-ħakk u mqabbeż)
English: Posology and method of administration, and/or 4.4.
Maltese: .2. Pożoloġija u metodu ta' kif għandu jingħata, u/jew 4.4.
English: Speak to your doctor if you need to inject your insulin by another method.
Maltese: Kellem lit-tabib tiegħek jekk teħtieġ li tinjetta l-insulina tiegħek permezz ta' metodu ieħor.
English: In post-marketing experience, cases of hypersensitivity associated with tofacitinib administration have been reported.
Maltese: It-test il-ġdid li għandu jiżdied mal-informazzjoni dwar il-prodott huwa sottolineat.
English: The swelling resolves completely by 3 weeks after vaccination.
Maltese: In-nefħa tirrisolvi kompletament sa 3 ġimgħat wara t-tilqim.
English: Further information on Nobivac Myxo-RHD Plus can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/nobivac-myxo-rhd-plus.
English: Nobivac Myxo-RHD Plus contains live myxoma vectored RHD virus strains 009 and MK1899.
Maltese: Nobivac Myxo-RHD Plus fih razez tal-virus ħaj RHD vettorat tal-missoma 009 u MK1899.
English: RHD, caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2), leads to blood clots in major organs such as the heart, lungs and kidneys leading to heart and respiratory failure when the heart and lungs do not work properly.
Maltese: L-RHD, ikkawżata mill-virus RHD klassiku (RHDV1) u l-virus RHD tat-tip 2 (RHDV2), twassal għal emboli tad-demm f'organi maġġuri bħall-qalb, il-pulmuni u l-kliewi li jwasslu għal insuffiċjenza tal-qalb u respiratorja meta l-qalb u lpulmuni ma jaħdmux sew.
English: These viruses have been modified so that they also produce proteins from the outer coat of either RHDV1 (strain 009) or RHDV2 (strain MK1899).
Maltese: Dawn il-viruses ġew modifikati sabiex jipproduċu wkoll proteini mill-kisja ta' barra ta' RHDV1 (razza 009) jew RHDV2 (razza MK1899) .
English: The most common side effects with Nobivac Myxo-RHD Plus (which may affect up to 1 in 10 animals) are a short-lived temperature increase of 1 to 2 °C and a small, non-painful swelling (maximum 2 cm diameter) at the injection site within the first two weeks after vaccination.
Maltese: L-effetti sekondarji l-aktar komuni b'Nobivac Myxo-RHD Plus (li jistgħu jaffettwaw sa annimal 1 minn kull 10) huma żieda fit-temperatura li ma ddumx ta' 1 sa 2 °C u nefħa żgħira, bla wġigħ (massimu ta' 2 cm dijametru) fis-sit tal-injezzjoni fl-ewwel ġimagħtejn wara t-tilqim.
English: Nobivac Myxo-RHD Plus is a vaccine.
Maltese: Nobivac Myxo-RHD Plus huwa vaċċin.
English: Other information about Nobivac Myxo-RHD Plus
Maltese: Informazzjoni oħra dwar Nobivac Myxo-RHD Plus
English: Nobivac Myxo-RHD Plus is a vaccine used in rabbits to reduce death and clinical signs due to myxomatosis and rabbit haemorrhagic disease (RHD).
Maltese: Nobivac Myxo-RHD Plus huwa vaċċin li jintuża fil-fniek biex jitnaqqsu l-imwiet u s-sinjali kliniċi minħabba l-missomatożi u l-marda emorraġika tal-fniek (RHD).
English: For the full list of side effects and restrictions for Nobivac Myxo-RHD Plus, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Nobivac Myxo-RHD Plus, ara l-fuljett ta' tagħrif.
English: When a rabbit is given the vaccine, the immune system recognises the weakened viruses in the vaccine as ‘foreign' and makes antibodies against both the myxoma virus and the RHD virus proteins.
Maltese: bħala ‘barranin' u tipproduċi antikorpi kontra kemm il-virus missoma kif ukoll il-proteini tal-virus RHD.
English: Four laboratory studies were conducted in young rabbits that showed protection began three weeks after vaccination and lasted 12 months against RHDV1 and RHDV2.
Maltese: Twettqu erba' studji fil-laboratorju fuq fniek żgħar li wrew li l-protezzjoni bdiet tliet ġimgħat wara ttilqim u damet 12-il xahar kontra RHDV1 u RHDV2.
English: What are the risks associated with Nobivac Myxo-RHD Plus?
Maltese: Kif jaħdem Nobivac Myxo-RHD Plus?
English: In addition, the company also presented field studies with the already authorised vaccine Nobivac Myxo-RHD which contains live myxoma vectored RHD virus strain 009 only.
Maltese: Barra minn hekk, il-kumpanija ppreżentat ukoll studji fuq il-post bil-vaċċin diġà awtorizzat Nobivac Mydio-RHD li fih razza tal-virus RHD ħaj vettorat tal-missoma 009 biss.
English: Why is Nobivac Myxo-RHD Plus authorised in the EU?
Maltese: Għalfejn Nobivac Myxo-RHD Plus huwa awtorizzat fl-UE?
English: For myxoma virus, rabbits were tested for antibodies only.
Maltese: Għall-virus tal-missoma, il-fniek ġew ittestjati għall-antikorpi biss.
English: Nobivac Myxo-RHD Plus is available as a freeze dried powder (lyophilisate) and solvent for suspension for injection and can only be obtained with a prescription.
Maltese: Nobivac Myxo-RHD Plus jiġi bħala trab imnixxef iffriżat (lijofilizzat) u solvent għal sospensjoni għal injezzjoni u jista' jinkiseb biss b'riċetta ta' tabib.
English: Fimbriae Types 2 and 3 (FIM)
Maltese: Fimbriae Tipi 2 u 3 (FIM)
English: (See section 4.8).
Maltese: (Ara sezzjoni 4.8).
English: West Point, PA 19486.
Maltese: Sumneytown Pike West Point, PA 19486.
English: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile France
Maltese: Sanofi Pasteur SA 1541 Avenue Marcel Mérieux 69280 Marcy l'Etoile Franza
English: Pack of 1 or 10.
Maltese: Pakkett ta' 1 jew 10.
English: EU/1/15/1079/001 EU/1/15/1079/002 EU/1/15/1079/003 EU/1/15/1079/004 EU/1/15/1079/005 EU/1/15/1079/006
Maltese: EU/1/15/1079/001 EU/1/15/1079/002 EU/1/15/1079/003 EU/1/15/1079/004
English: Poliovirus (Inactivated) Types 1/2/3
Maltese: Poljovirus (Inattivat) Tipi 1/2/3
English: Bordetella pertussis antigens (Pertussis Toxoid/Filamentous Haemagglutinin/ Fimbriae types 2 and 3/Pertactin)
Maltese: (Tossojd ta' Pertussis/Filamentous Haemagglutinin/ Fimbriae tipi 2 u 3/Pertactin)
English: Premature infants
Maltese: Trabi prematuri
English: 4.8 Undesirable effects a- Summary of the safety profile
Maltese: .8 Effetti mhux mixtieqa a- Sommarju tal-profil tas-sigurtà
English: Immunosuppressive therapy may interfere with the development of expected immune response (see section 4.4)
Maltese: Kura immunosuppressiva tista' tinterferixxi mal-iżvilupp tar-rispons immuni mistenni (ara sezzjoni 4.4)
English: Very Common Crying, irritability
Maltese: Biki, irritabilità
English: Multipack of 50 (with blue box).
Maltese: Pakkett multiplu ta' 50 (b'kaxxa blu).
English: d- Premature infants
Maltese: d- Trabi prematuri
English: Pack of 10 (without blue box).
Maltese: Pakkett ta' 10 (mingħajr kaxxa blu).
English: LLOQ = 4EU/mL are for anti-PT, anti-PRN and anti-FIM; and LLOQ = 3EU/mL for anti-FHA
Maltese: LLOQ = 4EU/mL qiegħed għal anti-PT, anti-PRN u anti-FIM; u LLOQ = 3EU/mL qiegħed għal anti-FHA
English: Antibody Thresholds
Maltese: Limiti ta' Antikorpi
English: Immunocompromised children
Maltese: Tfal immunokompromessi
English: • Hepatitis B: caused by the hepatitis B virus.
Maltese: • Epatite B: ikkawżata mill-virus tal-epatite B.
English: MCM Vaccine B.V. Robert Boyleweg 4 2333 CG Leiden The Netherlands
Maltese: MCM Vaccine B.V. Robert Boyleweg 4 2333 CG Leiden L-Olanda
English: • a rash
Maltese: • raxx
English: Stability data indicate that the vaccine is stable at temperatures up to 25°C for 150 hours.
Maltese: Dejta dwar l-istabbiltà tindika li l-vaċċin huwa stabbli f'temperaturi sa 25°C għal 150 siegħa.
English: Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution)
Maltese: Anti-Poljo tip 1 (dilwizzjoni ≥ 1:8) Anti-Poljo tip 2 (dilwizzjoni ≥ 1:8) Anti-Poljo tip 3 (dilwizzjoni ≥ 1:8)
English: Anti-diphtheria (≥ 0.01 IU/mL) Anti-tetanus (≥ 0.01 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response)
Maltese: Antidifterite (≥ 0.01 IU/mL) Antitetnu (≥ 0.01 IU/mL) Anti-PT (rispons tal-vaċċin)a Anti-FHA (rispons tal-vaċċin)a Anti-PRN (rispons tal-vaċċin)a Anti-FIM (rispons tal-vaċċin)a
English: 3 µg conjugated to meningococcal protein
Maltese: 3 µg ikkonjugat mal-proteina meningokokkali
English: Sodium phosphate Water for injections
Maltese: Sodium phosphate
English: After approximately 4 years, the percentages of children with anti-pertussis antibodies above LLOQ were as follows: anti-PT 58.4%, anti-FHA 80.9%, anti-PRN 66.1% and anti-FIM 94.3%.
Maltese: Wara madwar 4 snin, il-perċentwali ta' tfal b'antikorpi aktar mil-LLOQ kontra l-pertussis kienu kif ġej: anti-PT 58.4%, anti-FHA 80.9%, anti-PRN 66.1% u anti-FIM 94.3%.
English: 2, 4, 6 months
Maltese: 2, 4, 6 xhur
English: România Merck Sharp & Dohme Romania S.R.L.
Maltese: Merck Sharp & Dohme Romania S.R.L.
English: • allergic reaction, serious allergic reaction (anaphylactic reaction)
Maltese: • reazzjoni allerġika, reazzjoni allerġika serja (reazzjoni anafilattika)
English: The proportion of children seroprotected (anti-HBsAg ≥ 10 mIU/mL) after those vaccination schedules was 98.1% and 99.6%, respectively, and decreased to 65.7% and 70.2% approximately 4 years later.
Maltese: Il-proporzjon ta' tfal seroprotetti (anti-HBsAg ≥ 10 mIU/mL) wara dawk l-iskedi ta' tilqim kienu 98.1% u 99.6%, rispettivament, u nqasu għal 65.7% u 70.2% madwar 4 snin wara.
English: 40 D antigen units
Maltese: 40 D unitajiet ta' antiġen5
English: Anti-diphtheria (≥ 0.1 IU/mL) Anti-tetanus (≥ 0.1 IU/mL) Anti-PT (vaccine response) Anti-FHA (vaccine response) Anti-PRN (vaccine response) Anti-FIM (vaccine response) Anti-Polio type 1 (≥ 1:8 dilution) Anti-Polio type 2 (≥ 1:8 dilution) Anti-Polio type 3 (≥ 1:8 dilution) Anti-HBs Ag (≥ 10 mIU/mL)
Maltese: Antidifterite (≥ 0.1 IU/mL) Antitetnu (≥ 0.1 IU/mL) Anti-PT (rispons tal-vaċċin)a Anti-FHA (rispons tal-vaċċin)a Anti-PRN (rispons tal-vaċċin)a Anti-FIM (rispons tal-vaċċin)a Anti-Poljo tip 1 (dilwizzjoni ≥ 1:8) Anti-Poljo tip 2 (dilwizzjoni ≥ 1:8) Anti-Poljo tip 3 (dilwizzjoni ≥ 1:8) Anti-HBs Ag (≥ 10
English: Aluminium phosphate and amorphous aluminium hydroxyphosphate sulphate are included in the vaccine as adjuvants.
Maltese: Aluminium phosphate u amorphous aluminium hydroxyphosphate sulphate huma inklużi fil-vaċċin bħala sustanzi aġġuntivi.
English: Conjugated to meningococcal protein
Maltese: Ikkonjugat mal-proteina meningokokkali2
English: Table 1: List of Adverse Reactions
Maltese: Tabella 1: Lista ta' Reazzjonijiet Avversi Sistema tal-Klassifika talOrgani
English: 32 D antigen units
Maltese: 32 D unitajiet ta' antiġen5
English: Suspension for injection Multipack: 50 (5 packs of 10) pre-filled syringes (0.5 mL) without needle
Maltese: Pakkett multiplu: 50 siringa (5 pakketti ta' 10) mimlijin għal-lest (0.5 mL) mingħajr labra
English: 8 D antigen units
Maltese: 8 D unitajiet ta' antiġen5
English: (1/10,000 to <1/1,000) Very rare (<1/10,000)
Maltese: (≥1/10,000 sa <1/1,000)
English: Date of first authorisation: 15 February 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 Frar 2016
English: 2, 3, 4 months
Maltese: 2, 3, 4 xhur
English: Bordetella pertussis antigens Pertussis Toxoid (PT)
Maltese: Tossojd ta' Pertussis (PT)
English: Uncommon (1/1,000 to <1/100)
Maltese: Mhux Komuni (≥1/1,000 sa <1/100) Rari
English: Fever ≥39.5°C was observed in 3.7% of children (postbooster) and 0.2% to 0.8% of children (post-primary) receiving Vaxelis with PCV13 (see sections 4.4 and 4.5).
Maltese: Ġie osservat deni ≥39.5°C fi 3.7% tat-tfal (wara d-doża ta' riinfoz) u f'0.2% sa 0.8% tat-tfal (wara l-primarja) wara li rċevew Vaxelis ma' PCV13 (ara sezzjonijiet 4.4 u 4.5).
English: Suspension for injection 1 pre-filled syringe (0.5 ml) without needle 10 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: Suspensjoni għall-injezzjoni Siringa 1 mimlija għal-lest (0.5 ml) mingħajr labra 10 siringi mimlijin għal-lest (0 5 ml) mingħajr labra Siringa 1 mimlija għal-lest (0.5 ml) b'labra waħda 10 siringi mimlijin għal-lest (0.5 ml) b'10 labriet Siringa 1 mimlija għal-lest (0.5 ml) b'2 labriet 10 siringi mimlijin għal-lest (0.5 ml) b'20 labra
English: • Poliomyelitis (often just called polio): caused by viruses that affect the nerves.
Maltese: • Poljomelite (spiss imsejħa poljo): ikkawżata minn virusis li jaffettwaw in-nervituri.
English: Limited data from 111 pre-term newborn infants in clinical trials indicate that Vaxelis can be given to premature infants.
Maltese: Fi provi kliniċi, dejta limitata minn 111 -il tarbija li twieldu qabel iż-żmien tindika li Vaxelis jista' jingħata lil trabi prematuri.
English: 3 micrograms
Maltese: 3 mikrogrammi
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: Poliovirus (Inactivated) Type 1 (Mahoney)
Maltese: Tip 1 (Mahoney)
English: Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).
Maltese: Sensittività eċċessiva (bħal raxx, urtikarja, dispnea, eritema multiforme), reazzjoni anafilattika (bħal urtikarja, anġjoedema, edema, edema tal-wiċċ, xokk).
English: The booster dose in clinical studies was given at 11-12 months after a 2-dose primary series, at 12 months of age after a 3-dose primary series (2, 3, 4 months), and at 15 months of age after a 3-dose primary series (2, 4, 6 months).
Maltese: Id-doża ta' rinforz fi studji kliniċi ngħatat fl-età ta' 11-12-il xahar wara serje primarja ta' 2 dożi, fl-età ta' 12-il xahar wara serje ta' tilqim primarju ta' 3 dożi (2, 3, 4 xhur), u fl-età ta' 15-il xahar wara serje ta' tilqim primarju ta' 3 dożi (2, 4, 6 xhur).
English: Hrvatska Merck Sharp & Dohme d.o.o.
Maltese: Merck Sharp & Dohme d.o.o.
English: Ελλάδα
Maltese: Żewġ dożi
English: Uncommon Lymphadenopathy
Maltese: Limfadenopatija
English: No data are available in older children (see sections 4.8 and 5.1)
Maltese: M'hemm l-ebda dejta disponibbli fi tfal ikbar fl-età (ara sezzjonijiet 4.8 u 5.1).
English: No pharmacokinetic studies have been performed.
Maltese: Ma sarux studji farmakokinetiċi.
English: • previously had Guillain-Barré syndrome (temporary loss of feeling and movement) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Maltese: • kellhom is- sindrome ta' Guillain-Barré (telf temporanju ta' sensazzjoni u ta' movimenti) wara li jkunu ngħataw vaċċin li fih it-tossojd tat-tetnu (għamla inattivata ta' tossina tat-tetnu).
English: Lower FHA, PRN, IPV1 and IPV3 immune responses were observed after a 2-dose primary schedule (2, 4 months), although the clinical relevance of these data remain uncertain.
Maltese: Ġew osservati risponsi immuni aktar baxxi għal FHA, PRN, IPV1 u IPV3 wara skeda primarja ta' 2 dożi (2, 4 xhur), għalkemm ir-rilevanza klinika ta' din id-dejta tibqa' waħda inċerta.
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed using sensitive tests, for at least 30 days following vaccination.
Maltese: Peress li l-antiġen kapsulari polisakkarid ta' Hib jiġi eliminat fl-awrina, test pożittiv fl-awrina jista' jiġi osservat permezz ta' testijiet sensittivi, għal tal-inqas 30 jum wara t-tilqima.
English: Uncommon Sleep disorders including insomnia, restlessness
Maltese: Disturbi fl-irqad inkluż insomnja, irrikwitezza
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin, and polymyxin B).
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1 jew għal xi traċċa ta' residwi (glutaraldehyde, formaldehyde, neomycin, streptomycin, u polymyxin B).
English: Canada
Maltese: Il-Kanada
English: Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
Maltese: Vaxelis (DTaP-HB-IPV-Hib) huwa indikat għal tilqim primarju u bħala ta' riinforz fi trabi u tfal minn età ta' 6 ġimgħat, kontra d-difterite, it-tetnu, il-pertussis, l-epatite B, il-poljomelite u mard invażiv ikkawżat minn Haemophilus influenzae tip b (Hib).
English: Uncommon Rash, hyperhidrosis
Maltese: Raxx, iperidrożi
English: One dose (0.5 mL) contains:
Maltese: U KWANTITATTIVA Doża waħda (0.5 mL) fiha:
English: Uniform, cloudy, white to off-white suspension.
Maltese: Suspensjoni bajda għal offwajt, opaka u uniformi.
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Maltese: Vaċċin ikkonjugat għal difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA), poljomelite (inattivat) u Haemophilus tip b (adsorbit).
English: Uncommon Cough
Maltese: Mhux Komuni
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09
Maltese: Vaċċini, vaċċini batterjali u virali kkombinati, Kodiċi ATC:
English: Apnoea in very premature infants (≤28 weeks of gestation).
Maltese: Apnea fi trabi prematuri ħafna (≤ 28 ġimgħa ta' tqala).
English: Nervous system disorders Convulsion, febrile convulsion.
Maltese: Disturbi fis-sistema nervuża Aċċessjoni, aċċessjoni bid-deni.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali t'apnea u l-ħtieġa għal monitoraġġ respiratorju għal 48 sa 72 siegħa għandhom jiġu kkunsidrati meta tingħata l-ewwel serje ta' tilqim lil trabi prematuri ħafna (li jitwieldu wara ≤ 28 ġimgħa ta' tqala) u speċjalment f'dawk bi storja preċedenti ta' immaturità respiratorja.
English: and vomiting.
Maltese: meningitidis.
English: Multipack of 5 packs of 10 pre-filled syringes with no needle.
Maltese: Pakkett multiplu ta' 5 pakketti ta' 10 siringi mimlijin għal-lest mingħajr labra.
English: Tetanus Toxoid
Maltese: Tossojd tat-Tetnu
English: Other medicines or vaccines and Vaxelis
Maltese: Mediċini jew vaċċini oħra u Vaxelis
English: Almost all fevers were mild or moderate (<39.5°C) and transient (duration of ≤2 days).
Maltese: Kważi kull deni kien ħafif jew moderat (<39.5°C) u temporanju (tul ta' ≤jumejn).
English: cried continuously and could not be comforted for more than 3 hours within 48 hours of vaccination.
Maltese: − bkew kontinwament u ma setgħux jiġi kkonslati għal iktar minn 3 sigħat fi żmien 48 siegħa mit-tilqima.
English: Uncommon Pallor
Maltese: Disturbi vaskulari
English: Vaxelis can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule.
Maltese: Vaxelis jista' jintuża f'skeda imħallta ta' immunizzazzjoni b'tilqimhexavalenti/pentavalenti/hexavalenti kkombinat.
English: Long-term persistence of antibodies to pertussis antigens The persistence of pertussis antibodies was measured in children 4 or 5 years of age who had received Vaxelis at 2, 4 and 11-12 months of age.
Maltese: Il-perisistenza tal-antiġeni tal-pertussis tkejlet fi tfal fl-età ta' 4 jew 5 snin li kienu rċivew Vaxelis fletà ta' 2, 4 u 11-12-il xahar.
English: In a clinical study where Vaxelis was administered concomitantly with Prevenar 13 (PCV13) as a booster dose of both vaccines, fever ≥38.0°C was reported in 54.3% of children, compared to 33.1% to 40.7% of children during the primary series.
Maltese: Fi studju kliniku fejn Vaxelis ingħata fl-istess ħin ma' Prevenar 13 (PCV13) fejn iż-żewġ vaċċini ngħataw bħala doża ta' riinforz ġie rrapportat deni ≥38.0°C f'54.3% tat-tfal, meta mqabbel ma' 33.1% sa 40.7% tat-tfal matul is-serje primarja.
English: Vaxelis may be administered simultaneously with pneumococcal polysaccharide conjugate vaccines, rotavirus vaccines, measles, mumps, rubella (MMR) and varicella containing vaccines and meningococcal C conjugate vaccines.
Maltese: Vaxelis jista' jingħata fl-istess ħin ma' vaċċini polysaccharide pnewmokokkali kkonjugati, vaċċini ta' rotavirus, ħosba, gattone, rubella (MMR) u vaċċini li fihom il-variċella u vaċċini meningokokkali C kkonjugati.
English: The active substances per dose (0.5 mL):
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Doża waħda (0.5 ml):
English: {Label - Prefilled Syringe}
Maltese: Reazzjonijiet allerġiċi serji
English: Uncommon Rhinitis
Maltese: Komuni Ħafna Rimettar Komuni
English: Persistence of the immune response Long-term persistence of antibody to hepatitis B surface antigen
Maltese: Il-persistenza fit-tul tal-antikorp għall-antiġen tas-superfiċje tal-epatite B
English: 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al produced in yeast (Saccharomyces cerevisiae) by recombinant DNA technology produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Maltese: 1 adsorbit fuq aluminium phosphate (0.17 mg Al3+) 2 adsorbit fuq amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al3+) 3prodott fil-ħmira (Saccharomyces cerevisiae) bit-teknoloġija rikombinanti ta' DNA 4prodott f'ċelluli Vero