FrancophonIA/ELRC3.0 huggingface dataset:
English: Kogenate Bayer given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Maltese: Kogenate Bayer mogħti bħala injezzjoni ġo vina ġie studjat f'66 pazjent li qabel kienu rċevew kura bilfattur VIII tal-koagulazzjoni rikombinanti tal-bniedem u f'61 tifel u tifla li ma kinux.
English: The data provided on immune tolerance induction in patients with inhibitors showed that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Maltese: Id-data pprovduta dwar l-istimulazzjoni ta' tolleranza immunitarja fil-pazjenti b'inibituri wriet li xi pazjenti jibbenefikaw mid-dożaġġ għoli u l-inibitur jista' jiġi eliminat, madankollu d-data ma ġietx ikkunsidrata suffiċjenti biex tapprova b'mod speċifiku l-mediċina għal dan l-użu.
English: What are the risks associated with Kogenate Bayer?
Maltese: X'inhuma r-riskji assoċjati ma' Kogenate Bayer?
English: Kogenate Bayer given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Maltese: Kogenate Bayer mogħti b'doża għolja ġie studjat biex isir magħruf jekk huwiex effikaċi fit-tneħħija tal-antikorpi kontra l-fattur VIII mid-demm (proċess magħruf bħala stimulazzjoni ta' tolleranza immunitarja) sabiex il-kura bil-fattur VIII tibqa' effikaċi.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Hemm ukoll riskju bil-mediċini tal-fattur VIII li ċerti pazjenti jiżviluppaw inibituri (antikorpi) kontra lfattur VIII, b'hekk il-mediċina tieqaf taħdem u dan jirriżulta f'telf tal-kontroll tal-fsada.
English: Kogenate Bayer is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Maltese: Kogenate Bayer jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni jew infużjoni (dripp) ġo vina.
English: Kogenate Bayer is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Maltese: Kogenate Bayer huwa mediċina li tintuża għall-kura u l-prevenzjoni ta' fsada f'pazjenti ta' kull età b'emofilja A (disturb ta' fsada li jintiret ikkawżat minn nuqqas ta' fattur VIII).
English: Because of this, Kogenate Bayer has been compared with Kogenate to show that the two medicines are equivalent.
Maltese: Minħabba dan, Kogenate Bayer tqabbel ma' Kogenate biex jintwera li ż-żewġ mediċini huma ekwivalenti.
English: The European Commission granted a marketing authorisation valid throughout the EU for Kogenate Bayer on 4 August 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Kogenate Bayer fl-4 ta' Awwissu 2000.
English: The dose and duration of treatment depend on whether it is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Maltese: Id-doża u t-tul tal-kura jiddependu minn jekk jintużax għall-kura jew għallprevenzjoni ta' fsada jew waqt kirurġija, kif ukoll mil-livelli tal-fattur VIII tal-pazjent, is-severità talemofilja, il-firxa u l-post tal-fsada u l-kundizzjoni u l-piż tal-ġisem tal-pazjent.
English: In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.
Maltese: Fil-pazjenti li ma rċevewx kura qabel, madwar 90% tal-episodji ta' fsada rrispondew għall-kura b'injezzjoni waħda jew tnejn ġo vina.
English: The Agency concluded that Kogenate Bayer has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Maltese: L-Aġenzija kkonkludiet li Kogenate Bayer intwera li hu effikaċi fil-kura u fil-prevenzjoni ta' fsada f'pazjenti b'emofilja A u għandu profil ta' sigurtà aċċettabbli.
English: Kogenate Bayer is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Maltese: Kogenate Bayer jintuża biex jikkoreġi n-nuqqas tal-fattur VIII billi jissostitwixxi l-fattur VIII nieqes, b'hekk jagħti kontroll temporanju għad-disturb tal-fsada.
English: Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Maltese: Xi pazjenti jistgħu jiżviluppaw inibituri tal-fattur VIII, li huma antikorpi (proteini) li s-sistema immunitarja tal-ġisem tipproduċi kontra l-fattur VIII u li jistgħu jikkawżaw il-mediċina tieqaf taħdem li jwassal għal telf fil-kontroll tal-fsada.
English: Kogenate Bayer must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
Maltese: Kogenate Bayer m'għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għal fattur VIII talkoagulazzjoni tal-bniedem, għal proteina tal-ġurdien jew tal-ħamster, jew għal kwalunkwe sustanza oħra tiegħu.
English: For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Kogenate Bayer, ara l-fuljett ta' tagħrif.
English: 1 patch + 1 cleansing gel
Maltese: Stikk waħda + ġel li jnaddaf wieħed
English: The full EPAR for Competact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The studies lasted from 4 months to 2 years and involved 1,305 patients who took the combination.
Maltese: L-istudji damu bejn 4 xhur u sentejn u involvew 1,305 pazjenti li ngħataw ilkombinazzjoni.
English: Competact is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Maltese: Competact huwa mediċina diġà tiġi f'pilloli li jkun fihom żewġ sustanzi attivi, il-pijoglitażonu (15 mg) u l-idroklorur tal-metformina (850 mg).
English: In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
Maltese: Fl-istudji kollha, iż-żieda ta' 30 mg pijoglitażonu mal-metformina ġabet titjib fil-kontroll tal-glukożju fid-demm, bil-livelli tal-HbA1c ikomplu jitnaqqsu minn 0.64% għal 0.89% meta mqabbla mal-livelli rreġistrati bil-metformina biss.
English: This is a summary of the European public assessment report (EPAR) for Competact.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Competact.
English: Other information about Competact
Maltese: Aktar informazzjoni dwar Competact
English: What is Competact?
Maltese: Għal xiex jintuża Competact?
English: In addition, the company that markets Competact will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Competact fis-suq se tipproduċi materjal edukattiv għattobba li jippreskrivu l-mediċina, li se jkopri r-riskju possibbli ta' insuffiċjenza tal-qalb u kanċer filbużżieqa tal-urina bil-kuri li fihom pijoglitażonu, il-kriterji għall-għażla tal-pazjenti u l-ħtieġa ta' rieżami regolari tal-kura u li l-kura titwaqqaf jekk il-pazjenti ma jibqgħux jibbenefikaw minnha.
English: Elderly patients should have their kidney function monitored regularly.
Maltese: Il-pazjenti anzjani għandu jkollhom il-funzjoni tal-kliewi ssorveljata b'mod regolari.
English: At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur.
Maltese: Fil-bidu tal-kura, jistgħu iseħħu wġigħ addominali (uġigħ fl-istonku), dijarrea, nuqqas ta' aptit, nawżja (tħossok ma tiflaħx) u remettar.
English: What measures are being taken to ensure the safe and effective use of Competact?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Competact?
English: Competact must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding.
Maltese: Competact m'għandux jintuża f'każi ta' intossikazzjoni alkoħolika, ketoaċidożi dijabetika (livell għoli ta' ketoni), kundizzjonijiet li jistgħu jaffettwaw il-kliewi, u matul it-treddiegħ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Competact on 28 July 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Competact fit-28 ta' Lulju 2006.
English: Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Maltese: Il-pijoglitażonu waħdu ġie approvat fl-UE taħt l-isem Actos u jista' jintuża mal-metformina fuq pazjenti b'dijabete tat-tip 2 li ma jkunux ikkontrollati b'mod sodisfaċenti bil-metformina biss.
English: The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required.
Maltese: Is-CHMP kkonkluda li l-effikaċja tal-pijoglitażonu u l-metformina fid-dijabete tat-tip 2 ġiet ippruvata, u li Competact jissimplifika l-kura u jżid il-konformità meta tkun meħtieġa l-kombinazzjoni tas-sustanzi attivi.
English: They measured the level in the blood of a substance (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: Dawn kejlu l-livell fid-demm ta' sustanza (HbA1c), li jagħti indikazzjoni ta' kemm ilglukożju fid-demm ikun ikkontrollat tajjeb.
English: Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication.
Maltese: Saru tliet studji fuq Actos użat mal-metformina bħala pilloli separati biex jappoġġaw l-użu ta' Competact fl-istess indikazzjoni.
English: For the full list of side effects reported with Competact, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrapportati b'Competact, ara l-fuljett ta' tagħrif.
English: Competact is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.
Maltese: Competact jintuża f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti bil-metformina (mediċina antidijabetika) użata waħidha u mogħtija fl-ogħla doża possibbli.
English: Other side effects such as bone fracture, increased weight and oedema (swelling) may occur in less than 1 in 10 patients.
Maltese: Effetti sekondarji oħra bħal ksur fl-għadam, żieda fil-piż u oedema (nefħa) jistgħu jfeġġu f'inqas minn pazjent wieħed minn kull 10.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Competact, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Id-doża rakkomandata ta' Competact hija pillola darbtejn kuljum.
English: Strength Pharmaceutical Form Route of administration
Maltese: Qawwa Għamla Farmaċewtika
English: EU number
Maltese: Page 2 of 2
English: August 2015
Maltese: Awwissu 2015
English: Elderly (>60 years)
Maltese: Anzjani (>60 sena)
English: Immune response to Pandemrix (H1N1)v
Maltese: Rispons immuni għal Pandemrix (H1N1)v
English: GMT.
Maltese: GmbH.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/452/001
Maltese: EU/1/08/452/001
English: Pandemrix contains thiomersal
Maltese: Pandemrix fih thiomersal
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 May 2008
Maltese: AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Mejju 2008
English: Very rare1
Maltese: Rari ħafna1
English: Adult dose
Maltese: Doża tal-adulti
English: Serum
Maltese: fis-serum
English: The MAH submitted the data requested above on 5 August 2015 and an opinion was adopted by the CHMP on 28 April 2016.
Maltese: L-MAH issottometta d-dejta mitluba hawn fuq fil-5 ta' Awwissu 2015 u s-CHMP adotta opinjoni fit28 ta' April 2016.
English: 24-35 months
Maltese: 24-35 xahar
English: Please see details of the assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website.
Maltese: Jekk jogħġbok ara d-dettalji tal-valutazzjoni fir-rapport ta' valutazzjoni tas-CHMP EMEA/H/C/000832/II/0079 ippubblikat fuq is-sit web tal-EMA
English: Drowsiness Irritability Loss of appetite
Maltese: Irritabilità Telf ta' aptit
English: See sections 4.4, 4.8 and 5.1 for details.
Maltese: Ara sezzjonijiet 4.4, 4.8 u 5.1 għad-dettalji.
English: Excipients:
Maltese: Kontenut:
English: Half adult dose4
Maltese: Nofs doża tal-adulti 4
English: In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%).
Maltese: F'adulti b'età minn 18 sa 60 sena, l-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti wara ttilqim kienu uġigħ fis-sit tal-injezzjoni (87.8%), għeja (32.9%), uġigħ ta' ras (28.1%), uġigħ fil-ġogi (17.9%), uġigħ fil-muskoli (30.
English: Uncommon (≥1/1,000 to <1/100)
Maltese: Mhux komuni (≥1/1,000 to <1/100) Rari (≥1/10,000 to <1/1,000)
English: Common (≥1/100 to <1/10)
Maltese: Komuni ħafna (≥1/10) Komuni (≥1/100 to <1/10)
English: The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown.
Maltese: Ir-rilevanza klinika ta' titre ta' inibizzjoni tal-emagglutinazzjoni (HI) ≥1:40 fit-tfal mhux magħrufa.
English: Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.
Maltese: Pandemrix huwa vaċċin biex jipprevjeni l-influwenza kkawżata mill-virus A(H1N1)v 2009.
English: Pandemrix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Maltese: Pandemrix fih thiomersal bħala preservattiv u huwa possibbli li inti jista' jkollok reazzjoni allerġika.
English: In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%).
Maltese: F'individwi b'età > 60 sena, l-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti wara ttilqim kienu uġigħ fis-sit tal-injezzjoni (59.0%), uġigħ fil-muskoli (20.6%), għeja (17.9%), uġigħ ta' ras (17.6%) u uġigħ fil-ġogi (14.3%).
English: Month N=10
Maltese: Xahar N=10
English: Vaccination is not recommended in this age group.
Maltese: Tilqim mhux irrakkomandat f'dan il-grupp ta' età.
English: Additional information is available from the studies conducted with a vaccine similar in composition to Pandemrix but containing antigen derived from H5N1 viruses.
Maltese: Informazzjoni addizzjonali hija disponibbli minn istudji mwettqa b'vaċċin simili għal Pandemrix filkompożizzjoni iżda li fih antiġen derivat mill-virusis H5N1.
English: No fertility data are available.
Maltese: M'hemmx dejta disponibbli dwar il-fertilità.
English: 50 vials: suspension (antigen)
Maltese: KUNJETT TA' SUSPENSJONI (ANTIĠEN)
English: Uncommon Insomnia
Maltese: Mhux komuni Insomnja
English: 4according to protocol anti-HA antibody
Maltese: 4skont il-protokoll antikorp anti-HA
English: Post dose N=16
Maltese: Xahar N=16
English: Immune response to A/Netherlands/602/9 (H1N1)v-like1
Maltese: Rispons immuni għal A/Netherlands/602/9 (H1N1)v-like1
English: In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows:
Maltese: Fi studju kliniku (D-Pan-H1N1-009) fi tfal b'saħħithom b'età minn 6 xhur sa 35 xahar (imqassma fi gruppi b'età minn 6 sa 11, 12 sa 23 u 24-35 xahar) ir-rispons ta' l-antikorp anti-HA 21 ġurnata wara lewwel u t-tieni nofs doża ta' l-adulti (i.e. 0.25 ml) jew doża tal-adulti (i.e. 0.5 ml) ta' Pandemrix kien kif ġej:
English: See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months.
Maltese: Ara sezzjoni 5.1 dwar rispons immuni għal doża waħda u għal żewġ dożi ta' Pandemrix (H1N1)v, inkluż livelli ta' antikorpi wara 6 u 12-il xhar.
English: Angioedema, generalised skin reactions, urticaria
Maltese: Anġjoedima, reazzjonijiet ġeneralizzati fil ġilda, urtikarja
English: This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).
Maltese: (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi) u polysorbate 80 (4.86 milligrammi).
English: • Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions,
Maltese: • Avvenimenti avversi li għandhom jingħataw prijorità biex jiġu rrapurtati, i.e. reazzjonijiet avversi fatali u ta' periklu għal ħajja, reazzjonijiet avversi severi mhux mistennija, avvenimenti avversi ta' interess speċjali (AESI).
English: 1antigenically similar to A/California/7/2009 (H1N1)v-like
Maltese: 1jixbah b'mod antiġeniku lil A/California/7/2009 (H1N1)v-like
English: Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Maltese: Tagħrif mhux kliniku ottenut minn vaċċin mock-up fejn intużat razza ta' H5N1, ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali,
English: N=2 [95% CI]
Maltese: =2 [95% CI]
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jkun akkompanjat minn diversi sinjali newroloġiċi bħal disturbi transitorji fil-vista, parasteżija u movimenti toniċi-kloniċi tar riġlejn u d-dirgħajn matul l-irkupru.
English: Other medicines and Pandemrix
Maltese: Mediċini oħra u Pandemrix
English: Pandemrix should under no circumstances be administered intravascularly.
Maltese: Pandemrix m'għandu qatt jingħata b'mod intravaskulari.
English: Pandemrix consists of two containers:
Maltese: Pandemrix jikkonsisti f'żewġ kontenituri:
English: Total enrolled subjects N=75
Maltese: Individ wi totali irreġistr ati N=75
English: Seroconversion factor3
Maltese: serokonverżjoni3
English: Month 12 N=28
Maltese: Xahar 12 N=28
English: anti-HA
Maltese: Antikorp anti-HA
English: Twelve months after the first dose, the seroprotection rate was 85% in both age groups.
Maltese: 85% fiż-żewġ gruppi ta' età.
English: Month 6 N=22
Maltese: Xahar 6 N=22
English: Adults aged 18 years and older:
Maltese: Adulti b'età minn 18-il sena 'l fuq:
English: Month 12 N=31
Maltese: Xahar 12 N=31
English: Month 12 N=7
Maltese: Xahar 12 N=7
English: Gastrointestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Maltese: Sintomi gastro-intestinali (bħal dijarea, rimettar, uġigħ fl-addome, dardir)
English: It is recommended to equip the syringe with a 23-G needle.
Maltese: Huwa rrakkomandat li s-siringa tiġi mgħammra b'labra ta' 23-G.
English: - Verify influenza-specificity of hypocretin-specific CD4 T cells from narcoleptic patients by complementary assays and verify if crossreactive CD4 T cells are found among influenza-specific CD4 T cells from healthy subjects after vaccination with Pandemrix or nonadjuvanted H1N1v vaccine.
Maltese: - Ivverifika l-ispeċifiċità tal-influwenza ta' ċelloli CD4 T minn pazjenti b'narkolessija b'assaġġi kumplimentari u vverifika jekk jinstabux ċelloli CD4 T kross-reattivi fost ċelloli CD4 T speċifiċi għall-influwenza minn individwi b'saħħithom wara tilqima b'Pandemrix jew b'vaċċin H1N1v mhux aġġuvanat.
English: Day 42 N=17
Maltese: Ġurnata 42 N=17
English: One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
Maltese: - pakkett wieħed ta' 50 kunjett (ħġieġ tat-tip I) ta' 2.5 ml suspenjoni b'tapp (butyl rubber).
English: Day 42 N=22
Maltese: Ġurnata 42 N=22
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Maltese: AS03 stimulant magħmul minn squalene (10.69 milligrammi), DL-α-tocopherol (11.86 milligrammi)
English: Month 12 N=5
Maltese: Xahar 12 N=5
English: The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of 0.5 ml vaccine
Maltese: Il-volum wara li jitħallat kunjett 1 ta' suspensjoni (2.5ml) ma' kunjett 1 ta' emulsjoni (2.5ml) jikkorrispondi għal 10 dożi ta' 0.5ml ta' vaċċin
English: Day 42 N=18
Maltese: Ġurnata 42 N=18
English: Month 6 N=17
Maltese: Xahar 6 N=17
English: Total enrolled subjects N=33
Maltese: Individ wi totali irreġistr ati N=33
English: Month 6 N=18
Maltese: Xahar 6 N=18
English: Febrile convulsions
Maltese: Disturbi vaskulari
English: neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
Maltese: Disturbi newroloġiċi bħal enkefalomajlite (infjammazzjoni tas-sistema nervuża ċentrali), nevrite (infjammazzjoni tan-nervituri) u tip ta' paraliżi magħrufa bħala Sindrome ta' Guillain
English: Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups.
Maltese: 100% fiż-żewġ gruppi ta' età.
English: Day 21 N=18
Maltese: Ġurnata 21 N=18
English: GlaxoSmithKline Biologicals Branch of SmithKline Beecham Pharma GmbH & Co. KG Zirkustraße 40, D-01069 Dresden Germany
Maltese: KG Zirkustraße 40, D-01069 Dresden
English: Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali b'Pandemrix ma jindikawx tossiċita fis-sistema ripproduttiva (ara sezzjoni 5.3).
English: Full dose (D-Pan-H1N1-010)
Maltese: (D-Pan-H1N1-010)
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Maltese: Ma kienx hemm evidenza ta' żjieda fir-riskju ta' riżultati avversi f'aktar minn 100 tqala li kienu segwiti fi studju kliniku prospettiv.
English: Redness Swelling Shivering Sweating Fever >38°C Fever >39°C Diarrhoea
Maltese: Deni > 38°C Deni > 39°C Dijarea
English: Day 21 N=22
Maltese: Ġurnata 21 N=22
English: After 1 dose of 0.5 ml
Maltese: 0.5 ml
English: Day 21 N=17
Maltese: Ġurnata 21 N=17
English: STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A
Maltese: Virus maqsum, mhux attivat ta' l-influwenza li jkun fih antiġen ekwivalenti għal: Razza derivata minn A/California/07/2009/ (H1N1) bl-użu ta' NYMC
English: Total enrolled subjects N=66
Maltese: Total ta' Individ wi irreġistr ati N=66
English: Month N=22
Maltese: Xahar N=22
English: Month 6 N=15
Maltese: Xahar 6 N=15