FrancophonIA/ELRC3.0 huggingface dataset:
English: High exposures to ivabradine that may occur when ivabradine is given in combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Maltese: Bil-maqlub impedituri u mediċini li jġiegħlu iċCYP3A4 jaħdem iżjed qawwi jistgħu jaffetwaw sostanzjalment il-konċentrazzjonijiet tal-plażma ta' ivabradine (ara sezzjoni 4.5).
English: Drug-drug interaction studies have established that CYP3A4 inhibitors increase ivabradine plasma concentrations, while inducers decrease them.
Maltese: Studji fuq interazzjoni bejn mediċini wrew li limpedituri ta' CYP3A4 iżidu l-konċentrazzjoni tal-plażma ta' ivabradine waqt li l-indutturi jnaqqsuha.
English: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).
Maltese: Mhemmx bżonn ta' aġġustar tad-doża f'pazjenti li jbatu minn insuffiċjenza renali u minn tneħħija talkrejatinina ta' iktar minn 15 mL/min (ara sezzjoni 5.2).
English: Suspension (inactivated)
Maltese: Sospensjoni (inattivata)
English: --1 Lyophilisate (live attenuated) Canine distemper virus, strain CDV Bio 11/A
Maltese: --1 Lijofiliżejt (attenwat haj) Canine distemper virus, strejn CDV Bio 11/A
English: Canine adenovirus Type 2, strain CAV-2 Bio 13
Maltese: Canine adenovirus type 2, strejn CAV-2-Bio 13
English: Canine parvovirus Type 2b, strain CPV-2b Bio 12/B
Maltese: Canine parvovirus type 2b, strejn CPV-2b-Bio 12/B
English: Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB
Maltese: Leptospira interrogans serogrupp Australis serovar Bratislava, strejn MSLB 1088
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Maltese: Canine arainfluenza type 2 virus, strejn CPiV-2-Bio 15
English: *** International units.
Maltese: IU***
English: Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB
Maltese: Leptospira interrogans serogrupp Canicola serovar Canicola, strejn MSLB 1090
English: EMA/672709/2010 EMEA/H/C/000426
Maltese: EMA/672709/2010
English: The full EPAR for Ambirix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Ambirix jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Maltese: Vaċċin tal-Epatite A (inattivat) u epatite B (r DNA) (HAB) (assorbit)
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: L-antiġeni tal-wiċċ tal-virus tal-epatite B jsiru permezz ta' metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': isir minn batterju li jkun irċieva ġene (DNA), li jagħmilha kapaċi tipproduċi l-proteini.
English: This is a summary of the European public assessment report (EPAR) for Ambirix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ambirix.
English: Ambirix is a vaccine.
Maltese: Ambirix huwa vaċċin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ambirix to GlaxoSmithKline Biologicals s.a. on 30 August 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Ambirix valida fl-Unjoni Ewropea kollha lil GlaxoSmithKline Biologicals s.a. fit-30 ta' Awwissu 2002.
English: Ambirix led to the development of protective levels of antibodies against hepatitis A and B in between 98 and 100% of the vaccinated children one month after the last injection.
Maltese: Ambirix wassal għall-iżvilupp ta' antikorpi protettivi kontra l-epatite A u B f'madwar 98 u 100% tat-tfal imlaqqma f'xahar wara l-aħħar injezzjoni.
English: Ambirix contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Maltese: Ambirix fih ammonti żgħar ta' vajrusis tal-epatite A inattivati u l-'antiġene tas-superfiċje' (proteini mis-superfiċje) tal-vajrus tal-epatite B.
English: Three main studies of Ambirix were carried out in a total of 615 children from one year of age.
Maltese: Tliet studji ewlenin ta' Ambirix saru f'total ta' 615-il tifel u tifla minn età ta' sena.
English: The most common side effects with Ambirix (seen in more than one in 10 doses of the vaccine) are loss of appetite, irritability, headache, fatigue (tiredness) and pain and redness at the site of injection.
Maltese: L-aktar effetti sekondarji komuni b'Ambirix (dehru f'aktar minn 1 f'10 dożi tal-vaċċin) huma uġigħ ta' ras, telf ta' aptit, uġigħ fil-punt fejn ingħatat l-injezzjoni, ħmura, għeja kbira u irritabilità.
English: This summary was last updated in 11-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2010.
English: The active substances in Ambirix have been available in other vaccines authorised in the European Union (EU): Ambirix contains the same ingredients as Twinrix Adult, which has been authorised since 1996, and as Twinrix Paediatric, which has been authorised since 1997.
Maltese: Is-sustanzi attivi f'Ambrix ilhom jinsabu f'vaċċini oħrajn awtorizzati fl-Unjoni Ewropea (UE): Ambirix fih l-istess ingredjenti bħal Twinrix Adult, li ġie awtorizzat mill-1996, u bħala Twinrix Paediatric, li ġie awtorizzat mill-1997.
English: What is the risk associated with Ambirix?
Maltese: X'inhu r-riskju assoċjat ma' Ambirix?
English: Why has Ambirix been approved?
Maltese: Għalfejn ġiex approvat Ambirix?
English: What is Ambirix?
Maltese: X'inhu Ambirix?
English: An additional study in 208 children compared the vaccine's effectiveness when a six-month or a 12-month interval was used between the two injections.
Maltese: Studju addizzjonali f'208 itfal qabbel l-effikaċja tal-vaċċin meta ntuża intervall ta' sitt xhur jew intervall ta' 12-il xahar bejn iż-żewġ injezzjonijiet.
English: Ambirix is used to protect against hepatitis A and hepatitis B (diseases that affect the liver) in children between one and 15 years of age who are not already immune to these two diseases.
Maltese: Ambirix jintuża biex jipproteġi kontra infezzjoni b'epatite A u b'epatite B (mard li jaffettwa l-fwied) fi tfal u adolexxenti ta' etajiet bejn sena u 15-il sena li mhumiex diġà immuni għal dawn iż-żewġ mardiet.
English: The three vaccines are used to protect against the same diseases, but Twinrix Adult and Twinrix Paediatric are given as a three-dose schedule.
Maltese: It-tliet vaċċini huma użati sabiex jipproteġu kontra l-istess mard, iżda Twinrix Adult u Twinrix Paediatric jingħataw bħala skeda ta' tliet dożi.
English: Where a booster dose of hepatitis A or B is desired, Ambirix, or a separate hepatitis A or B vaccine may be given.
Maltese: Tnejn mill-istudji qabblu Ambirix ma' vaċċini oħrajn kontra l-epatite A u B.
English: Because Ambirix and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult were used to support the use of Ambirix.
Maltese: Minħabba li Ambirix u Twinrix Adult fihom sustanzi identiċi, xi dejta użata biex tappoġġa l-użu ta' Twinrix Adult intużat biex tappoġġa l-użu ta' Ambrix.
English: How has Ambirix been studied?
Maltese: Kif ġie studjat Ambirix?
English: Other information about Ambirix
Maltese: Għal xiex jintuża Ambirix?
English: The CHMP decided that Ambirix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Ambirix huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni biex jitqieħed fis-suq.
English: For the full list of all side effects reported with Ambirix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Ambirix, ara l-fuljett ta' tagħrif.
English: Ambirix should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic).
Maltese: Ambirix ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe mis-sustanzi attivi, kwalunkwe mis-sustanzi l-oħra jew għal neomiċina (antibijotiku).
English: These levels were maintained in over 93% of the children after two years.
Maltese: Dawn il-livelli nżammu fi 'l fuq minn 93% tat-tfal wara sentejn.
English: Ambirix is used as a two-dose schedule and protection against hepatitis B may not be obtained until after the second dose.
Maltese: Ambrix jintuża bħala programm ta' żewġ dożi u protezzjoni kontra l-epatite B tista' ma tinkisibx sa wara t-tieni doża.
English: Ambirix is given as two injections six to 12 months apart into the muscle of the upper arm, or into the thigh in very young children.
Maltese: Ambirix jingħata bħala żewġ injezzjonijiet sitt sa tnax -il xahar bogħod minn xulxin fil-muskolu talparti ta' fuq tad-driegħ jew fil-koxxa fi tfal żgħar ħafna.
English: Ambirix is a vaccine that contains inactivated (killed) hepatitis A virus and parts of the hepatitis B virus as active substances.
Maltese: Ambirix huwa vaċċin li fil-vajrusis inattivati (maqtulin) tal-epatite A u partijiet mill-vajrus tal-epatite B bħala sustanzi attivi.
English: EMA/596737/2014 EMEA/H/C/003906
Maltese: EMEA/H/C/003906
English: Ketoconazole HRA is available as tablets (200 mg).
Maltese: Ketoconazole HRA huwa disponibbli bħala pilloli (200 mg).
English: Ketoconazole blocks the activity of a group of enzymes in the adrenal glands involved in the production of cortisol, such as 17 alpha-hydroxylase or 11β-hydroxylase.
Maltese: Ketoconazole jimblokka l-attività ta' grupp ta' enzimi fil-glandoli adrenali involuti fil-produzzjoni ta' kortisol, bħal 17 alpha-hydroxylase jew 11β-hydroxylase.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole HRA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Ketoconazole HRA jinstab fissit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: 1 In the context of a referral procedure under Article 31 of Directive 2001/83/EC.
Maltese: 1 Fil-kuntest tal-proċedura ta' referenza skont l-Artikolu 31 tad-Direttiva 2001/83/KE. Aktar informazzjoni tista' tinstab hawn.
English: The average dose used was 600 to 800 mg per day.
Maltese: Id-doża medja użata kienet 600 sa 800 mg kuljum.
English: The usual treatment dose is between 400 mg and 1,200 mg per day taken in two or three divided doses.
Maltese: Id-doża normali tal-kura hija bejn 400 mg u 1,200 mg kuljum meħuda f'żewġ jew tliet dożi diviżi.
English: The most common side effects with Ketoconazole HRA are adrenal insufficiency (too low a level of the hormones produced by the adrenal gland), nausea (feeling sick), vomiting, abdominal pain (stomach ache), diarrhoea, pruritus (itching), rash and increase in blood levels of liver enzymes.
Maltese: L-effetti sekondarji l-iktar komuni b'Ketoconazole HRA huma insuffiċjenza adrenali (livell baxx wisq talormoni prodotti mill-glandola adrenali), dardir, rimettar, uġigħ addominali (uġigħ fl-istonku), dijarea, prurite (ħakk), raxx u żieda fil-livelli ta' enzimi tal-fwied fid-demm.
English: Ketoconazole treatment was shown to normalise urine cortisol levels in 43 to 80% of patients.
Maltese: Kura b'ketoconazole ntweriet li tinnormalizza l-livelli ta' kortisol flawrina fi 43 sa 80% tal-pazjenti.
English: If liver enzyme levels in the blood increase beyond three times the normal maximum (a sign of possible liver problems) or in case of symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain (stomach ache) or dark urine that may suggest a liver problem, treatment must be stopped.
Maltese: Jekk il-livelli ta' enzimi fid-demm jiżdiedu iktar minn 3 darbiet ilmassimu normali (sinjal ta' problemi tal-fwied possibbli) jew f'każ ta' sintomi bħal nuqqas ta' aptit, dardir, rimettar, għeja, suffejra, uġigħ addominali (uġigħ fl-istonku) jew awrina skura li jistgħu jissuġġerixxu problema fil-fwied, il-kura għandha titwaqqaf.
English: Because the number of patients with Cushing's syndrome is low, the disease is considered ‘rare', and Ketoconazole HRA was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 April 2012.
Maltese: Minħabba li n-numru ta' pazjenti bis-sindromu ta' Cushing huwa wieħed baxx, il-marda hija kkunsidrata ‘rari', u Ketoconazole HRA ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fit-23 ta' April 2012.
English: The full EPAR and risk management plan summary for Ketoconazole HRA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Ketoconazole HRA jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ketoconazole HRA on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ketoconazole HRA fid-19 ta' Novembru 2014.
English: This is a summary of the European public assessment report (EPAR) for Ketoconazole HRA.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ketoconazole HRA.
English: The most serious side effects are liver problems which can be detected early through regular monitoring.
Maltese: L-effetti sekondarji l-iktar serji huma problemi tal-fwied li jistgħu jiġu skoperti permezz ta' monitoraġġ regolari.
English: The active substance in Ketoconazole HRA is ketoconazole.
Maltese: Is-sustanza attiva f'Ketoconazole HRA hija ketoconazole.
English: Other information about Ketoconazole HRA
Maltese: Informazzjoni oħra dwar Ketoconazole HRA
English: What are the risks associated with Ketoconazole HRA?
Maltese: X'inhuma r-riskji assoċjati ma' Ketoconazole HRA?
English: Ketoconazole can also block the production of other hormones produced by the adrenal gland which are often raised in Cushing's syndrome.
Maltese: Ketoconazole jista' wkoll jimblokka l-produzzjoni ta' ormoni oħra prodotti mill-glandoli adrenali li ta' spiss jiżdiedu fissindromu ta' Cushing.
English: The active substance in Ketoconazole HRA, ketoconazole, is a well known substance that has been authorised for several decades for the treatment of fungal infections.
Maltese: Is-sustanza attiva f'Ketoconazole HRA, ketoconazole, hija sustanza magħrufa sew li ilha awtorizzata għal bosta deċenni għall-kura ta' infezzjonijiet fungali.
English: Why is Ketoconazole HRA approved?
Maltese: Għaliex ġie approvat Ketoconazole HRA?
English: Ketoconazole can still be found in topical medicines (medicines applied to the skin) to treat fungal infections.
Maltese: Ketoconazole għadu jinstab f'mediċini topiċi (mediċini applikati fuq il-ġilda) għall-kura ta' infezzjonijiet fungali.
English: Ketoconazole HRA
Maltese: Kif jintuża Ketoconazole HRA?
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Maltese: Is-sindromu ta' Cushing huwa marda kkaratterizzata minn produzzjoni eċċessiva tal-ormon kortisol mill-glandoli adrenali, żewġ glandoli li jinstabu fuq il-kliewi.
English: Ketoconazole HRA is a medicine used to treat adults and children above the age of 12 years with Cushing's syndrome.
Maltese: Ketoconazole HRA huwa mediċina użata għall-kura ta' adulti u tfal ta' aktar minn 12-il sena bissindromu ta' Cushing.
English: The CHMP considered that the use of Ketoconazole HRA to treat Cushing's syndrome was well established in medical practice and documented in the scientific literature.
Maltese: Is-CHMP ikkunsidra li l-użu ta' Ketoconazole HRA għall-kura tas-sindromu ta' Cushing huwa stabbilit sew fil-prattika medika u ddokumentat fil-letteratura xjentifika.
English: Because ketoconazole is a well-known substance, and its use in Cushing's syndrome is well established, the applicant presented data from the published literature on more than 800 patients with Cushing's syndrome who were treated with ketoconazole either alone or in combination with other treatments.
Maltese: Minħabba li ketoconazole huwa sustanza magħrufa sew, u l-użu tiegħu fis-sindromu ta' Cushing huwa stabbilit sew, l-applikant ippreżenta dejta minn letteratura ppubblikata fuq aktar minn 800 pazjent bissindromu ta' Cushing li ġew ikkurati b'ketoconazole jew waħdu jew flimkien ma' kuri oħrajn.
English: The patient's liver function should be checked with blood tests before treatment is started and regularly for the following 6 months.
Maltese: Il-funzjoni tal-fwied tal-pazjent għandha tiġi kkontrollata b'testijiet tad-demm qabel tinbeda l-kura u regolarment għas-6 xhur ta' wara.
English: For the full list of all side effects and restrictions with Ketoconazole HRA, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Ketoconazole HRA, ara l-fuljett ta' tagħrif.
English: The company that makes Ketoconazole HRA will also provide doctors who will use Ketoconazole HRA with a letter containing information regarding the risks of side effects, particularly of liver injury, and how to use the medicine properly.
Maltese: Barra minn hekk, Ketoconazole HRA m'għandux jintuża flimkien ma ċerti mediċini li jistgħu jżidu r-riskju ta' effetti sekondarji serji.
English: DTPw HBV (separate)
Maltese: DTPw HBV (separati)
English: Novartis Vaccines and Diagnostics GmbH & Co. KG
Maltese: Novartis Vaccines and Diagnostics GmbH & Co.
English: ≥ 30 IU ≥ 60 IU ≥ 4 IU 10 µg
Maltese: UI ≥ 4 UI 10 µg
English: DTPw-HBV (combined)
Maltese: DTPw HBV (kombinat)
English: Date of latest renewal: 19 July 2006.
Maltese: Data ta' l-aħħar tiġdid: 19 ta' Lulju 2006.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Doża 1 (0.5 ml) fiha:
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA05.
Maltese: Kategorija farmakoteropewtika: vaċċini batterjali u virali kombinati, Kodiċi ATC: J07CA05.
English: 1 Adsorbed on aluminium hydroxide, hydrated
Maltese: 1 adsorbit fuq aluminium hydroxide, idratat
English: Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Maltese: Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa.
English: * in a subgroup of infants not administered hepatitis B vaccine at birth, 89.9% of subjects had anti-HBs titres † cut-off accepted as indicative of protection †† vaccine response: % of subjects considered to have responded to the Bordetella pertussis antigen
Maltese: * f'sottogrupp ta' trabi li ma ngħatalhomx il-vaċċin ta' l-epatite B mat-twelid, 89.9% ta' l-individwi † il-punt tal-waqfa aċċettat bħala wieħed li juri protezzjoni †† rispons tal-vaċċin: % ta' l-individwi kkunsidrati li rrispondew għall-antiġen tal-Bordetella pertussis
English: Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Maltese: Temperatura ta' ≥ 40.0°C fi żmien 48 siegħa, mhux minħabba kawża oħra li tista tiġi identifikata.
English: See section 6.5 for the number of doses per vial.
Maltese: Ara sezzjoni 6.5 għan-numru ta' dożi li fiha kull fjala.
English: N° of symptom checklists Local symptoms (%)
Maltese: Listi ta' kontroll tannumru ta' sintomi
English: The D and T toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formalin inactivation using established technology.
Maltese: It-toxoids D u T jiġu ppreparati mit-tossini ta' kolturi ta' Corynebacterium diphtheriae u Clostridium tetani li jiġu inattivati permezz tal-formalina bl-użu ta' teknoloġija stabbilita.
English: Do not freeze
Maltese: Aħżen fi friġġ
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Maltese: • L-epatite B: L-epatite B hija kkawżata mill-virus ta' l-epatite B.
English: Four different schedules have been studied (6-10-14 weeks, 2-4-6 months; 3-4-5 months and 3-4½-6 months) according to routine vaccination practices in different countries with three doses administered within the first
Maltese: Erba' skedi differenti ġew studjati (6-10-14-il ġimgħa, 2-4-6 xhur; 3-4-5 xhur u 3-4½-6 xhur) skond ilprattiċi ta' tilqim ta' rutina f'pajjiżi differenti bi tliet dożi mogħtija fl-ewwel sitt xhur mit-twelid.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 July 1996.
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 19 ta' Lulju 1996.
English: • Clinical trials: In clinical studies, the most commonly reported adverse events were reactions at the injection site, including redness, swelling and pain.
Maltese: • Provi kliniċi: Waqt studji kliniċi, l-aktar effetti avversi li kenu rrappurtati b'mod komuni, kienu reazzjonijiet fis-sit ta' l-injezzjoni fosthom ħmura, nefħa u uġigħ.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.3)
Maltese: Dan il-prodott mediċinali fih Thiomersal (kompost organomerkurjali) bħala preservattiv u għalhekk jista jkun hemm reazzjonijiet ta' sensitizzazzjoni (ara sezzjoni 4.3).
English: Tritanrix HepB is available in the following pack sizes:
Maltese: Tritanrix HepB huwa disponibbli fil-pakketti li ġejjin:
English: Tritanrix HepB, suspension for injection
Maltese: Tritanrix HepB, suspensjoni għall-injezzjoni
English: Booster vaccination:
Maltese: • Id-difterite:
English: A history of febrile convulsions, a family history of convulsions, a family history of SIDS (Sudden Infant Death Syndrome) and a family history of an adverse reaction following Tritanrix HepB vaccination do not constitute contra-indications.
Maltese: Storja ta' aċċessjonijiet bid-deni, storja fil-familja ta' aċċessjonijiet, storja fil-familja ta' SIDS (Sindrome ta' Mewt f'Daqqa fit-Trabi), u storja medika ta' effett avvers wara tilqim b'Tritanrix HepB, m'humiex kontra-indikazzjonijiet.
English: 0.26 mg Al3+ 0.37 mg Al3+ 3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology - The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.
Maltese: 0.26 mgAl3+ 0.37 mg Al3+ 3 manifatturat f'ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA
English: General disorders and administration site conditions: very common: fever, swelling, pain and redness very rare: allergic reactions including anaphylactic and anaphylactoid reactions and serum sickness very common: unusual crying, irritability
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata: komuni ħafna: deni, nefħa, wġigħ u ħmura rari ħafna: reazzjonjiet allerġiċi inkluż reazzjonijiet anafilattiċi u anafilaktojd u marda tixbaħ lil serum komuni ħafna: biki mhux tas-soltu, irritabilità
English: Take special care with Tritanrix HepB:
Maltese: Tagħtix Tritanrix HepB:
English: 5 ml of suspension in a vial (type I glass) for 10 doses with a plunger stopper (rubber butyl) - pack size of
Maltese: 5 ml ta' suspensjoni fi fjala (ħġieġ tat-tip I) għal 10 dożi magħluqa bi planġer (lastku butyl)- pakkett bi fjala
English: Your child will remain under medical supervision for 30 minutes after each injection.
Maltese: Ibnek/bintek jibqa'/tibqa' taħt superviżjoni medika għal 30 minuta wara kull injezzjoni.
English: • Pertussis (Whooping cough): Pertussis is a highly infectious illness.
Maltese: • Il-pertussis (sogħla konvulsiva):
English: Tritanrix HepB contains diphtheria (D), tetanus (T) toxoids, inactivated pertussis bacteria (Pw) and the purified major surface antigen of the hepatitis B virus (HBV), adsorbed on aluminium salts.
Maltese: Tritanrix HepB fih toxoids tad-difterite (D), u tat-tetnu (T), batterji inattivati tal-pertussis (Pw) u l-antiġenu prinċipali tal-wiċċ ippurifikat tal-virus ta' l-epatite B (HBV), adsorbiti fuq aluminium salts.