FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension Not all pack sizes may be marketed.
Maltese: 0.5 ml ta' suspensjoni fi fjala (ħġieġ tat-tip I) għal doża waħda b'tapp (rubber butyl) f'pakketti ta' daqsijiet li ġejjin: - pakkett bi fjala 1 ta' trab flimkien ma' fjala 1 ta' suspensjoni - pakkett b'100 fjala ta' trab flimkien ma' 100 fjala ta' suspensjoni Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall-skop kummerċjali.
English: Psychiatric disorders: very common: irritability
Maltese: Disturbi psikjatriċi: komuni ħafna: irritabbiltà
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
Maltese: U KWANTITATTIVA Wara r-rikostituzzjoni, doża 1 (0.5 ml) jkun fiha: Toxoid tad-difterite1
English: Total: 0.40 milligrams Al3+ 3 produced in Saccharomyces cerevisae cells by recombinant DNA technology
Maltese: Total: 0.40 milligrammi Al3+ 3 manifatturat f'ċelluli ta' Saccharomyces cerevisae b'teknoloġija rikombinanti tad-DNA
English: Do not be alarmed by this list of possible side effects.
Maltese: Tieħux qatgħa b'din il-lista ta' effetti sekondarji li jista' jkun hemm.
English: Tel: +49 6421 39 29 17 Fax: +49 6421 39 47 20
Maltese: Tel: +49 6421 39 29 17
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of suspension - pack size of 100 vials of powder plus 100 vials of suspension.
Maltese: 1 ml ta' suspensjoni fi fjala (ħġieġ tat-tip I) għal 2 dożi b'tapp (rubber butyl) f'pakketti ta' daqsijiet li ġejjin: - pakkett bi fjala 1 ta' trab flimkien ma' fjala 1 ta' suspensjoni - pakkett b'100 fjala ta' trab flimkien ma' 100 fjala ta' suspensjoni.
English: The lyophilised Haemophilus influenzae type b (HIB) component is a white powder.
Maltese: Il-komponent lajofilizzat tal-Haemophilus influenzae tat-tip b (HIB) huwa trab abjad.
English: • Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Maltese: • L-Epatite B: Infezzjoni bil-virus ta' l-epatite B tikkawża nefħa (infjammazjoni) fil-fwied.
English: Quintanrix is for deep intramuscular injection, preferably in the anterolateral thigh.
Maltese: Quintanrix qiegħed għal injezzjoni fil-fond ġol-muskolu , preferibbilment ġol-koxxa anterolaterali.
English: The following schedules have been studied in clinical trials: 2-4-6 months, 3-4-5 months and 6-10-14 weeks.
Maltese: L-iskedi li ġejjin kienu studjati fi provi kliniċi: 2-4-6 xhur, 3-4-5 xhur u 6-10-14-il ġimgħa.
English: MANUFACTURER'S BATCH NUMBER LOT:
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR LOTT:
English: Results from different studies show that, overall, 95.5% and 99.9% of subjects had anti-diphtheria and anti-tetanus titres ≥ 0.1 IU/ml one month after completion of the primary vaccination course.
Maltese: Riżultati minn studji differenti juru li b'kollox, 95.5% u 99.9% tas-suġġetti kellhom titri ≥ 0.1 IU/ml kontra t-tetnu u kontra d-difterite xahar wara li kien komplut il-kors ta' tilqim primarju.
English: Allergic reactions, including anaphylactoid reactions and urticaria, have been reported very rarely following vaccination with DTP, hepatitis B and HIB containing vaccines.
Maltese: Reazzjonijiet allerġiċi, inkluż reazzjonijiet anafilattiċi u urtikarja kienu rrappurtati rari ħafna wara tilqim b'vaċċini li kien fihom DTP, epatite B u HIB.
English: However the stability has been demonstrated for 8 hours at 25°C after reconstitution.
Maltese: Madanakollu intweriet stabbiltà għal-8 sigħat f'temperatura ta' 25°C wara r-rikostituzzjoni.
English: 5 ml of suspension in a vial (type I glass) for 10 doses with a stopper (rubber butyl) in a pack size of 50 vials of powder plus 50 vials of suspension.
Maltese: 5 ml ta' suspensjoni fi fjala (ħġieġ tat-tip I) għal 10 dożi b'tapp (rubber butyl) f'pakkett b' 50 fjala ta' trab flimkien ma' 50 fjala ta' suspensjoni.
English: Nervous system disorders: very common: drowsiness rare: collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions Respiratory, thoracic and mediastinal disorders rare: bronchitis, coughing
Maltese: Disturbi fis-sistema nervuża: komuni ħafna: ngħas rari: kollass jew stat bħal f'xokk (episodju ipotoniku-iporisponsiv), aċċessjonijiet Disturbi respiratorji toraċiċi u medjastinali: rari: bronkite, sogħla
English: - The active substances contained in 1 doses (0.5 ml) of Quintanrix are:
Maltese: - Is-sustanzi attivi li fiha doża waħda (0.5 ml) ta' Quintanrix huma:
English: More than 99% of subjects were considered to have responded to the pertussis component of the vaccine, which was defined as the appearance of antibodies in initially seronegative subjects (i.e. subjects with pre-vaccination titres < 15 ELU/ml) or a post-vaccination titre at least equal to pre-vaccination levels in subjects initially seropositive due to maternallyderived antibodies.
Maltese: Aktar minn 99% tas-suġġetti kienu kkunsidrati li rrispondew għall-komponent pertussis tal-vaċċin, li kien definit bħala d-dehra ta' antikorpi f'suġġetti li inizjalment kienu seronegattivi (jiġifieri suġġetti b'titri < 15 ELU/ml qabel it-tilqim) jew titri wara t-tilqim ta' lanqas daqs il-livelli ta' qabel it-tilqim f'suġġetti li inizjalment kienu seropożittivi minħabba antikorpi meħuda mingħand l-omm.
English: STORING QUINTANRIX
Maltese: X'HINU QUINTANRIX
English: There will be some type of serious complications such as: mental retardation, cerebral palsy, deafness, epilepsy or partial blindness.
Maltese: Ikun hemm xi tipi ta' kumplikazzjonijiet serji bħal tfigħ lura fliżvilupp mentali, paraliżi ċerebrali, truxija, epilessija jew nuqqas ta` dawl.
English: GlaxoSmithKline AB Tel: + 46 31 67 09 00 info.produkt@gsk.com
Maltese: Tel: + 46 31 67 09 00 info.produkt@gsk.com
English: The hepatitis B and Haemophilus influenzae type b components of Quintanrix can only help to protect your child against infections with hepatitis B or Haemophilus influenzae type b viruses.
Maltese: Il-komponenti ta' l-epatite B u l-Haemophilus influenzae tat-tip b ta' Quintanrix jistgħu jgħinu biss biex f'ibnek/f'bintek jilqgħu kontra infezzjonijiet permezz tal-viruses ta' l-epatite B u l- Haemophilus influenzae tat-tip b.
English: - The other ingredients in the vaccine are: lactose, thiomersal (preservative), sodium chloride and water for injections.
Maltese: - L-ingredjenti l-oħra tal-vaċċin huma: lattosju, thiomersal (preservattiv), sodium chloride u ilma għall-injezzjonijiet.
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA META JISKADI JIS {XX/SSSS}
English: Booster vaccination:
Maltese: • Id-Difterite:
English: Powder in a vial (type I glass) for 10 doses with a stopper (rubber butyl).
Maltese: Trab ġo fjala (ħġieġ tat-tip I) għal 10 dożi b'tapp (rubber butyl).
English: Data from clinical trials show that Quintanrix, when given as a booster dose in the second year of life, induces a greater than 10-fold increase in mean antibody titre with respect to prebooster levels for all vaccine components.
Maltese: Tagħrif minn provi kliniċi juri li Quintanrix, meta jingħata bħala rinforz fl-età ta' sentejn, jinduċi tkabbir ta' aktar minn 10 darbiet fit-titru medju ta' l-antikorpi meta mqabbla mal-livelli ta' qabel ir-rinforz għallkomponenti kollha tal-vaċċin.
English: Thiomersal Sodium chloride Water for injections
Maltese: Sodium chloride Ilma għall-injezzjonijiet
English: The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”.
Maltese: Is-sogħla ħafna drabi ġġib magħha tħarħir (whooping), mnejn ġie l-isem komuni ‘whooping cough' (sogħla konvulsiva).
English: 6, 10, 14 weeks schedule N = 97
Maltese: Skeda tas-6, l-10 ul-14-il ġimgħa N = 97
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Maltese: • Kollass jew stat bħal f'xokk (episodju ipotoniku-iporisponsiv) fi żmien 48 siegħa.
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: induration, fever (axillary > 39°C; rectal > 39.5°C) Quintanrix was administered as a booster to 435 infants in the second year of life.
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata: komuni ħafna: uġigħ, ħmura u nefħa, deni (taħt l-abt ≥ 37.5°C; fir-rektum ≥ 38°C) komuni: ebusija, deni (taħt l-abt ≥ 37.5°C; fir-rektum ≥ 38°C) Quintanrix ġie amministrat bħala rinforz lil 435 tarbija fl-età ta' sentejn.
English: General disorders and administration site conditions: very common: pain, redness and swelling, fever (axillary ≥ 37.5°C; rectal ≥ 38°C) common: fever (axillary > 39°C; rectal > 39.5°C) uncommon: induration
Maltese: Disturbi ġenerali u kundizzjonijiet ta' mnejn jingħata: komuni ħafna: uġigħ, ħmura u nefħa, deni (taħt l-abt ≥ 37.5°C; fir-rektum ≥ 38°C) komuni: deni (taħt l-abt ≥ 37.5°C; fir-rektum ≥ 38°C) mhux komuni: ebusija
English: • Pertussis (Whooping cough): Pertussis is a highly infectious illness.
Maltese: • Il-Pertussis (sogħla konvulsiva):
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI /TIĠDID TA' LAWTORIZZAZZJONI
English: After the completion of the primary series, a booster should be administered preferably before the end of the second year of life.
Maltese: Wara t-tmiem tas-sensiela ta' tilqim primarju, għandu jiġi amministrat rinforz preferibbilment qabel mat-tarbija tagħlaq sentejn.
English: This leaflet was last approved on:
Maltese: Id-Detentur Ta' l-Awtorizzazzjoni għat-Tqegћid fis-Suq u l-Manifattur:
English: FURTHER INFORMATION
Maltese: AKTAR INFORMAZZJONI
English: 3, 4, 5 months schedule N = 107
Maltese: skeda tat-3, ir-4 u l-5 xahar N = 107
English: In the absence of compatibility studies, the reconstituted Quintanrix vaccine must not be mixed with other medicinal products.
Maltese: Fin-nuqqas ta' studji ta' kompatibilità, il-vaċċin Quintanrix rikostitwit m'għandux jitħallat ma prodotti mediċinali oħra.
English: The doctor or nurse will give Quintanrix as an injection into the muscle.
Maltese: It-tabib jew l-infermier jagħtu Quintanrix bħala injezzjoni fil-muskolu.
English: 2.5 µg conjugated to tetanus toxoid as a carrier
Maltese: 2.5 µg konjugat ma' toxoid tat-tetnu bħala ġarrier
English: Gastrointestinal disorders: very common: loss of appetite rare: vomiting
Maltese: Disturbi gastro-intestinali: komuni ħafna: nuqqas t'aptit rari: rimettar
English: Haemophilus influenzae type b polysaccharide
Maltese: Polysaccharide tal-Haemophilus influenzae tat-tip b:
English: Side effects that occurred during clinical trials with Quintanrix were as follows:
Maltese: Effetti oħra li ġraw waqt provi kliniċi bi Quintanrix kienu kif ġej:
English: Powder and suspension for suspension for injection The liquid diphtheria, tetanus, pertussis (whole cell), hepatitis B (DTPw-HBV) component is a turbid white suspension.
Maltese: Trab u suspensjoni għal suspensjoni għall-injezzjoni Il-komponent likwidu tad-difterite, tetnu, pertussis (ċellula sħiħa), u epatite B (DTPw-HBV) huwa supensjoni bajda mdardra.
English: B. PACKAGE LEAFLET
Maltese: B'ĦAFNA DOŻI
English: Results from one pilot study showed that, for 63 infants primed according to a 6, 10, 14 week schedule, > 80% still had antibodies to diphtheria, tetanus, HBs and PRP at levels considered to be protective.
Maltese: Riżultati minn studju pilota wieħed urew li għal 63 tarbija imlaqqma primarjament skond l-iskeda tas-6, l-10 u l-14-il ġimgħa, > 80% kien għad kellhom antikorpi għad-difterite, għat-tetnu, għall-HBs u għall-PRP f'livelli kkunsidrati bħala protettivi.
English: Quintanrix is a vaccine used in children to prevent five infectious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and Haemophilus influenzae type b (a type of bacteria).
Maltese: Quintanrix huwa vaċċin użat fit-tfal biex jilqa' kontra ħames mardiet infettivi: difterite, tetnu (lockjaw), pertussis (sogħla konvulsiva), epatite B u Haemophilus influenzae tat-tip b ( tip ta' batterju).
English: Chiron-Behring GmbH & Co. Postfach 1630-35006 Marburg Germany
Maltese: Postfach 1630-35006 Marburg Il-Ġermanja
English: • Drowsiness
Maltese: • Aċċessjonijiet
English: Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed) - The active substances contained in 1 dose (0.5 ml) of Quintanrix are:
Maltese: Quintanrix trab u suspensjoni għal suspensjoni għall-injezzjoni Vaċċin (adsorbit) tad-difterite, it-tetnu, il-pertussis (ċellula sħiħa), l-epatite B (rDNA) u lHaemophilus tat-tip B konjugat - Is-sustanzi attivi li fiha doża waħda (0.5 ml) ta' Quintanrix huma:
English: Quintanrix is indicated for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Haemophilus influenzae type b and for booster immunisation of young children during the second year of life.
Maltese: Quintanrix huwa indikat għat-tilqim primarju tat-trabi (fl-età ta' sena) kontra id-difterite, it-tetnu, ilpertussis, l-epatite B u mard invażiv ikkawżat mill-Haemophilus influenzae tat-tip b u għat-tilqim ta' rinforz tat-tfal żgħar fl-età ta' sentejn.
English: Limited data show that there is no interference with the response to Measles-Mumps-Rubella (MMR) and OPV antigens.
Maltese: Tagħrif limitat juri li m'hemmx interferenza mar-rispons ta' l-antiġeni tal-Ħożba-Gattone-Rubella (MMR) u tal-vaċċin orali tal-poljo.
English: Important information about some of the ingredients of Quintanrix
Maltese: Informazzjoni importanti dwar xi sustanzi ta' Quintanrix
English: The booster dose should preferably be given at least 6 months after the last primary dose.
Maltese: Id-doża ta' rinforz għandha preferibbilment tingħata mill-anqas 6 xhur wara l-aħħar doża primarja.
English: • Coughing
Maltese: • Sogħla
English: • if after previously having Quintanrix or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse (floppiness) or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination
Maltese: ♦ Deni għoli (‘l fuq minn 40° C) fi żmien 48 siegħa mit-tilqima ♦ Kollass jew stat bħal f'xokk fi żmien 48 siegħa mit-tilqima ♦ Biki persistenti li jdum tliet sigħat jew aktar fi żmien 48 siegħa mit-tilqima ♦ Aċċessjonijiet b`deni għoli jew mingħajr deni għoli fi żmien 3 ijiem mit-tilqima
English: Quintanrix should under no circumstances be administered intravascularly.
Maltese: Quintanrix m'għandu qatt jingħata taћt l-ebda ċirkostanza b'mod intravaskulari.
English: The reconstituted vaccine is a homogeneous turbid white suspension.
Maltese: Il-vaċċin rikostitwit huwa suspensjoni uniformi bajda u mdardra.
English: For 10 doses: - pack size of 50 vials of powder plus 50 vials of liquid
Maltese: Għal 10 dożi: - pakkett b'50 fjala ta' trab flimkien ma' 50 fjala ta' likwidu
English: Primary vaccination:
Maltese: Tilqim primarju:
English: The vaccine cannot cause diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B or Haemophilus influenzae type b infections.
Maltese: Il-vaċċin ma' jistax jikkawża infezzjonijiet taddifterite, tat-tetnu (lockjaw), tal-pertussis (sogħla konvulsiva), ta' l-epatite B jew tal-Haemophilus influenzae tat-tip b.
English: • Temperature of ≥ 40.0 °C within 48 hours, not due to another identifiable cause.
Maltese: • Temperatura ≥ 40.0
English: Quintanrix powder and suspension for suspension for injection, multidose Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Maltese: Quintanrix trab u suspensjoni għal suspensjoni għall-injezzjoni, ħafna dożi Vaċċin (adsorbit) tad-difterite, tetnu, pertussis (ċellula sħiħa), epatite B (rDNA) u Haemophilus tattip b konjugat
English: Powder in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Trab ġo fjala (ħġieġ tat-tip I) għal 2 dożi b'tapp (rubber butyl).
English: Quintanrix is a white slightly milky liquid obtained by mixing the vial containing the diphtheria (D), tetanus (T), whole cell pertussis (Pw) and hepatitis B (HBV) liquid (DTPw-HBV) with the vial containing the Haemophilus influenzae type b (HIB) powder.
Maltese: Quintanrix huwa likwidu abjad kemmxejn bħall-ħalib li jinkiseb bit-taħlit tal-fjala li fiha l-likwidu (DTPw-HBV) tad-difterite (D), it-tetnu (T) iċ-ċellula sħiħa tal-pertussis (Pw) u l-epatite B (HBV), mal-fjala li fiha t-trab ta' l- Haemophilus influenzae type b (HIB).
English: The HIB component of the vaccine does not protect against diseases due to capsular serotypes other than type b of Haemophilus influenzae or against meningitis caused by other organisms.
Maltese: Il-komponent tal-HIB tal-vaċċin ma jipproteġix kontra mard permezz ta' serotipi kapsulari oħra ħlief dawk tat-tip b tal-Haemophilus influenzae jew kontra meninġite ikkawżata minn organiżmi oħrajn.
English: GlaxoSmithKline Lietuva UAB Tel. +370 264 90 00 info.lt@gsk.com
Maltese: +370 264 90 00 info.lt@gsk.com
English: Quintanrix powder and suspension for suspension for injection Diphtheria, tetanus, pertussis (whole cell), hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed)
Maltese: Quintanrix trab u suspensjoni għal suspensjoni għall-injezzjoni Vaċċin (adsorbit) tad-difterite, tetnu, pertussis (ċellula sħiħa), epatite B (rDNA) u Haemophilus tattip b konjugat
English: In this leaflet:
Maltese: Tilqim ta' rinforz:
English: Gastrointestinal disorders: very common: loss of appetite
Maltese: Disturbi gastro-intestinali: komuni ħafna: nuqqas t'aptit
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: DETENTUR TA' L-AWTORIZZAZZJONI GĦATQEGĦID FIS-SUQ GlaxoSmithKline Biologicals s.a.
English: • if your child experienced problems of the nervous system (such as repetitive fits, decrease of consciousness) within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
Maltese: • jekk ibnek/bintek kellu/kellha xi problemi fis-sistema nervuża (bħal aċċessjonijiet ripetittivi, nuqqas ta' koxjenza) fi żmien sebat ijiem wara li tlaqqam/tlaqqmet kontra l-pertussis (sogħla konvulżiva).
English: Quintanrix is available in the following pack sizes: - pack size of 1 vial of powder plus 1 vial of liquid - pack size of 100 vials of powder plus 100 vials of liquid.
Maltese: Quintanrix jinstab fil-pakketti tad-daqsijiet li ġejjin: - pakkett bi fjala 1 ta' trab flimkien ma' fjala oħra ta' likwidu
English: Storing Quintanrix
Maltese: KIF TAĦŻEN QUINTANRIX
English: 2.5 micrograms conjugated to tetanus toxoid as a carrier
Maltese: 2.5 mikrogrammi konjugat ma' toxoid tat-tetnu bħala ġarrier
English: Slovenija GlaxoSmithKline d.o.o.
Maltese: España GlaxoSmithKline S.A.
English: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4) 4.9 Overdose
Maltese: Waqfien tan-nifs għal xi ħin fit-trabi mwieldin ħafna qabel iż-żmien (≤ 28 ġimgħa ta' tqala) (ara sezzjoni 4.4)
English: In paediatric vaccination it is often practice to co-administer different injectable vaccines at separate injection sites, during the same session.
Maltese: Fit-tilqim pedjatriku hija prattika frekwenti li vaċċini differenti li jiġu injettati jingħataw flimkien f'siti ta' injezzjoni separati fl-istess sessjoni.
English: This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Maltese: Dan il-prodott mediċinali fih thiomersal bħala preservattiv u huwa possibbli li ibnek/bintek ikollu/ikollha reazzjoni allerġika.
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 Quintanrix.
Maltese: Storja ta' aċċessjonijiet bid-deni, storja fil-familja ta' konvulżjonijiet jew is-Sindrome ta' Mewt f'Daqqa fit-Trabi (SIDS) m'humiex ta' kontra-indikazzjoni għall-użu ta' Quintanrix.
English: The seroprotection rates for anti-HBs (≥10 mlU/ml) observed with the 6, 10, 14 week schedule was lower as shown in the table below, but is unlikely to be clinically relevant due to the small sample size:
Maltese: Ir-rati ta' seroprotezzjoni għall-kontra l-HBs (≥10 mlU/ml) osservati fl-iskeda tas-6, l10 u l-14-il ġimgħa kienu aktar baxxi kif muri fit-tabella hawn taħt, iżda dan x'aktarx m'huwiex klinikamnet rilevanti minħabba d-daqs żgћir tal-kampjun:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/301/003
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI EU/1/04/301/003
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering 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 ta' waqfien tan-nifs għal xi ħin u l-bżonn ta' monitoraġġ respiratorju għal 48-72 siegħa, għandhom jiġu kkunsidrati meta l-kors ta' tilqim primarju jingħata lit-trabi mwieldin ħafna qabel iż-żmien (twieldu ≤ 28 ġimgħa ta' tqala) u speċjalment f'dawk li diġà kellhom immaturità respiratorja.
English: BATCH NUMBER
Maltese: Doża 1
English: FI.PT@gsk.com
Maltese: TAL-PRODOTT FIL-QOSOR
English: The following information is intended for medical or healthcare professionals only:
Maltese: Id-Detentur Ta' l-Awtorizzazzjoni għalt-Tqegħid fis-Suq u l-Manifattur:
English: METHOD AND ROUTE(S) OF ADMINISTRATION intramuscular use
Maltese: MANIFATTUR TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Do not use after the expiry date stated on the pack.
Maltese: Tużax wara d-data ta' skadenza li tidher fuq il-pakkett.
English: HIB infection also causes inflammation of the throat.
Maltese: L-infezzjoni tal-HIB tikkawża wkoll infjammazzjoni fil-gerżuma.
English: Adverse reactions reported after booster vaccination are listed below.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DTPw HBV for Quintanrix
Maltese: KIF JINGĦATA QUINTANRIX
English: • Haemophilus influenzae type b (HIB): HIB infection most frequently causes brain inflammation (swelling).
Maltese: • Il-Haemophilus influenzae tat-tip b (HIB):
English: Member State EU/EEA
Maltese: Stat Membru UE / ŻEE
English: 5.1 Pharmacodynamic properties
Maltese: 5.1 Karatteristiċi farmakodinamiċi
English: The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands as concerned Member States.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet sottomessa lirRenju Unit bħala l-Istat Membru ta' referenza u lill-Awstrija, il-Belġju, ir-Repubblika Ċeka, idDanimarka, Franza, il-Ġermanija, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Lussemburgu, il-Polonja, ilPortugall, is-Slovakkja, Spanja u n-Netherlands bħala l-Istati Membri kkonċernati.
English: INN Strength Pharmaceutical form
Maltese: INN Qawwa Forma farmaċewtika
English: Amoxicillin is a broad-spectrum penicillin.
Maltese: Amoxicillin huwa penicillin spettru wiesa'.
English: Route of administration
Maltese: U METODU TA 'AMMINISTRAZZJONI
English: Having considered all the data submitted the CVMP concluded that:
Maltese: Wara li kkunsidra d-data kollha ppreżentata, is-CVMP ikkonkluda li:
English: Luxembourg Eurovet Animal Health BV Handelsweg 25
Maltese: Lussemburgu Eurovet Animal Health BV Handelsweg 25
English: Extrapolation of the safety and efficacy of the reference product to Solamocta
Maltese: Estrapolazzjoni tas-sigurtà u l-effikaċja tal-prodott ta' referenza għal Solamocta
English: Colloidal anhydrous silica is a flow aid.
Maltese: Il-colloidal anhydrous silica tgħin il-fluss.