FrancophonIA/ELRC3.0 huggingface dataset:
English: At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
Maltese: Gaucher ta' tip 3 kienet 31.4-67.2% ta' dik fil-plażma.
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph (see sections 4.4 and 5.3).
Maltese: Pazjenti rġiel għandhom jibqgħu jużaw metodu affidabbli ta' kontraċezzjoni waqt it-teħid ta' Miglustat Gen.Orph (ara sezzjonijiet 4.4 u 5.3).
English: Miglustat Gen.Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Maltese: Miglustat Gen.Orph huwa indikat għall-kura ta' manifestazzjonijiet newroloġiċi progressivi f'pazjenti adulti u pazjenti pedjatriċi li għandhom il-marda Niemann-Pick ta' tip Ċ (ara sezzjonijiet 4.4, u 5.1).
English: Miglustat Gen.Orph 100 mg hard capsules miglustat
Maltese: Miglustat Gen.Orph 100 mg kapsuli ibsin miglustat
English: Magnesium stearate.
Maltese: Mhux applikabbli.
English: Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥ 1/1,000 to <1/100, rare: ≥ 1/10,000 to <1/1,000, very rare: <1/10,000).
Maltese: Reazzjonijiet avversi minn provi kliniċi u rappurtar spontanju li seħħew f'>1% tal-pazjenti, huma mniżżlin fit-tabella taħt skont is-sistema tal-klassifika tal-organi u skond il-frekwenza (komuni ħafna: ≥1/10, komuni: ≥1/100, <1/10,
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose.
Maltese: Fil-biċċa l-kbira miglustat huwa eliminat permezz ta' eskrezzjoni renali, b'irkupru mill awrina tal-mediċina mhux mibdula li jammonta għal 70-80% tad-doża.
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50200 mg t.i.d.
Maltese: Fi 11-il prova klinika dwar indikazzjonijiet differenti, 247 pazjent kienu kkurati b'miglustat b'dożaġġ ta' 50-200 mg t.i.d. għal tul medju ta' 2.1 sena.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gen.Orph (logo)
Maltese: FIS-SUQ Gen.Orph (logo)
English: • Miglustat Gen.Orph is used to treat mild to moderate type 1 Gaucher disease in adults.
Maltese: • Miglustat Gen.Orph huwa wżat għall-kura tal-marda ta' Gaucher ta' tip 1 ħafifa sa moderata fl-adulti.
English: Capsule contents
Maltese: Kapsula iebsa.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg miglustat For the full list of excipients, see section 6.1.
Maltese: Kull kapsula fiha 100mg ta' miglustat Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Nervous system disorders Very common
Maltese: Studji ta' trasmissjoni tan-nervaturi mhux normali
English: Use of Miglustat Gen.Orph in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Maltese: L-użu ta' Miglustat Gen.Orph f'pazjenti b'indeboliment kbir tal-kliewi (b'rata ta' tneħħija tal-krejatinina ta' < 30 ml/min/1.73 m2) mhux irrakkomandat.
English: Miglustat Gen.Orph 100 mg hard capsules are white opaque cap and body, hard gelatin capsules size 4 of 14.0 mm length.
Maltese: Miglustat Gen.Orph kapsuli ibsin ta' 100 mg huma għatu u korp opak abjad, kapsuli ta' ġelatina iebsa ta' daqs 4 ta' tul 14.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg miglustat
Maltese: - Is-sustanza attiva hi miglustat 100 mg.
English: PHARMACEUTICAL FORM Hard capsule.
Maltese: Qoxra tal-kapsula Gelatin,
English: Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Maltese: Madwar 37% tal-pazjenti fil-provi kliniċi bil-marda ta' Gaucher ta' tip 1 u 58% tal-pazjenti fi prova klinika bil-marda ta' Niemann-Pick ta' tip Ċ irrappurtaw li qabdithom rogħda meta ħadu l-kura.
English: Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and less libido.
Maltese: Effetti sekondarji possibli oħrajn huma spażmi jew dgħjufija fil-muskoli, għeja, sirdat u tħossok ma tiflaħx, depressjoni, diffikultà biex torqod, tinsa u tnaqqis fil-libido.
English: Miglustat Gen.Orph contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Maltese: Miglustat Gen.Orph fih is-sustanza attiva miglustat li tappartieni għal grupp ta' mediċini li jaffettwaw il-metaboliżmu.
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Gen.Orph (see section 4).
Maltese: It-tabib tiegħek jista' jnaqqas id-doża tiegħek, eż., għall-kapsula waħda (100 mg) darba jew darbtejn kuljum, jekk inti ssofri minn dijarea meta tieħu Miglustat Gen.Orph (ara sezzjoni 4).
English: The efficacy of Miglustat Gen.Orph in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Maltese: L-effikaċja ta' Miglustat Gen.Orph fi tfal u adoloxxenti b'età minn 0-17-il sena bil-marda ta' Gaucher tat-tip 1 għada ma ġietx determinata s'issa.
English: e.mail: info@biovalleyinvestmentspartner.it
Maltese: Biovalley Investments Partner (B.I.P.) Tel: +39 040 899 2219 e.mail: info@biovalleyinvestmentspartner.it
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Maltese: Manifestazzjonijiet fl-għadam tal-marda ta' Gaucher tat-tip 1 kienu evalwati fi 3 studji kliniċi open label f'pazjenti kkurati b'miglustat 100 mg t.i.d. għal perijodu sa sentejn (n = 72).
English: • For type 1 Gaucher disease: for adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Maltese: • Għall -marda ta' Gaucher ta' tip 1: Għall-adulti, id-doża tas-soltu hija kapsula (100 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: NAME OF THE MEDICINAL PRODUCT Miglustat Gen.Orph 100 mg hard capsules
Maltese: Miglustat Gen.Orph 100mg kapsuli ibsin
English: How to store Miglustat Gen.Orph
Maltese: Tiħux Miglustat Gen.Orph
English: • Miglustat Gen.Orph is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
Maltese: • Miglustat Gen.Orph huwa wżat ukoll għall-kura ta' sintomi newroloġiċi progressive fil marda ta' Niemann-Pick ta' tip Ċ fl-adulti u t-tfal.
English: The benefit to the patient of treatment with Miglustat Gen.Orph should be evaluated on a regular basis (see section 4.4).
Maltese: Il-benefiċċju tal-kura b'Miglustat Gen.Orph għall-pazjent għandu jiġi vvalutat fuq bażi regolari (ara sezzjoni 4.4).
English: Elderly There is no experience with the use of Miglustat Gen.Orph in patients over the age of 70.
Maltese: Anzjani M'hemmx esperjenza bl-użu ta' Miglustat Gen.Orph f'pazjenti b'età 'l fuq minn 70 sena.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: TAL-UŻU SIGUR EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).
Maltese: koordinazzjoni mhux normali, ipoestesija (sensazzjoni tal-mess imnaqqsa), dispepsja (ħruq ta' stonku),
English: Until further information is available, it is advised that before seeking to conceive, male patients should cease Miglustat Gen.Orph and maintain reliable contraceptive methods for 3 months thereafter.
Maltese: Qabel ma tkun disponibbli aktar informazzjoni, huwa rrakkomandat li pazjenti rġiel għandhom iwaqqfu Miglustat Gen.Orph u jibqgħu jużaw metodi affidabbli ta' kontraċezzjoni għat-3 xhur ta' wara qabel ma jippruvaw jikkonċepixxu.
English: Miglustat Gen.Orph may make you feel dizzy.
Maltese: Miglustat Gen.Orph jista' jikkawża sturdament.
English: Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Maltese: 16 u 33/19 darba l-ogħla doża rrakkomandata għall-bniedem (200 mg t.i.d.).
English: This means a daily maximum of three capsules (300 mg).
Maltese: (300 mg).
English: Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Maltese: (tnaqqis ta' madwar 22% fis- Cmax u tnaqqis ta' madwar 14% fl-AUC kien osservat fi studju żgħir ta' gruppi paralleli).
English: Male patients should maintain reliable contraceptive methods while taking Miglustat Gen.Orph.
Maltese: Għandek tuża metodu ta' kontraċezzjoni effettiv waqt li tieħu Miglustat Gen.Orph.
English: Other medicines and Miglustat Gen.Orph
Maltese: Mediċini oħra u Miglustat Gen.Orph
English: Gastrointestinal disorders Very common
Maltese: sturdament Disturbi gastro-intestinali
English: Nausea, vomiting, abdominal distension/discomfort, constipation, dyspepsia
Maltese: Tqalligħ, rimettar, nefħa/skumdità addominali, stitikezza, dispepsja Disturbi muskolu-skeltrali u tal-connective tissue Komuni
English: Miglustat Gen.Orph works by inhibiting the enzyme called ‘glucosylceramide synthase' which is responsible for the first step in the synthesis of most glycosphingolipids.
Maltese: Miglustat Gen.Orph jaħdem billi jinibixxi l-enzima msejjħa ‘glucosylceramide synthase' li hija responsabbli għallewwel pass fis-sintesi tal-biċċa l-kbira tal-glycosphingolipids.
English: They could be signs of peripheral neuropathy, due to side effects of Miglustat Gen.Orph or they could be due to existing conditions.
Maltese: Dawn jistgħu jkunu sinjali ta' newropatija periferali, minħabba effetti sekondarji ta' Miglustat Gen.Orph jew jistgħu jkunu dovuti għall-kondizzjonijiet eżistenti.
English: In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Maltese: (per eżempju tnaqqis f'sucrose, lactose u fit-teħid ta' karboidrati oħra), għat-teħid ta' miglustat bejn likliet, u/jew għal prodotti mediċinali kontra d-dijarea bħal loperamide.
English: There is limited experience with the use of Miglustat Gen.Orph in Niemann-Pick type C disease patients under the age of 4 years.
Maltese: Hemm esperjenza limitata bl-użu ta' Miglustat Gen.Orph f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ taħt l-età ta' 4 snin.
English: There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Maltese: Hemm relazzjoni mill-qrib bejn il-funzjoni tal-kliewi u t tneħħija ta' miglustat, u l-espożizzjoni għal miglustat tiżdied ħafna f'pazjenti b'indeboliment serju talkliewi (ara sezzjoni 5.2).
English: The survey included a case series of 66 patients treated with miglustat outside of the clinical trial for a mean duration of 1.5 years.
Maltese: każijiet ta' 66 pazjent ikkurati b'miglustat barra mill-prova klinika għal medja ta' tul ta' żmien ta' 1.5 snin.
English: Hepatic impairment Miglustat Gen.Orph has not been evaluated in patients with hepatic impairment.
Maltese: Miglustat Gen.Orph ma kienx evalwat f'pazjenti b'indeboliment tal-fwied.
English: Oral use.
Maltese: ġenotossiċità.
English: • For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Maltese: Għall-adulti u adoloxxenti ('l fuq minn 12-il sena), id doża tas-soltu hija żewġ kapsuli (200 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
English: Polyamide/aluminium/PVC/Aluminium blister supplied as a box of 12 blisters, each blister containing 7 capsules providing a total of 84 capsules.
Maltese: Folja ta' Polyamide/aluminium/PVC/Aluminium fornuta f'kaxxa li fiha 12-il folja.
English: Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Gen.Orph; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Maltese: It-tkabbir għandu jiġi ssorveljat f'pazjenti pedjatriċi u adoloxxenti waqt kura b'Miglustat Gen-Orph; biex titkompla t-terapija il-bilanċ tal-benefiċċju u r-riskju għandu jerġa'
English: Gelatin,
Maltese: U L-UŻU.
English: Miglustat Gen.Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.
Maltese: Miglustat Gen.Orph huwa indikat għall-kura mill-ħalq ta' pazjenti adulti li għandhom il-marda ta' Gaucher ta' tip 1 b'severità minn ħafifa sa moderata.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali jingħata li b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: White opaque cap and body, hard gelatin capsules size 4 of about 14.0 mm length.
Maltese: Kapsuli bojod ta' ġelatina iebsa, b'għatu opak u korp ta' daqs 4 ta' tul ta' madwar 14.0 mm.
English: The benefit of treatment with Miglustat Gen.Orph for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with Miglustat Gen.Orph.
Maltese: Il-pazjenti rġiel għandhom jużaw metodi ta' kontraċezzjoni affidabbli waqt il-kura b'Miglustat Gen.Orph, u għal 3 xhur wara li titwaqqaf il-kura.
English: Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats.
Maltese: Effetti oħrajn li dehru fl-annimali b'dożi li jirriżultaw f'livelli ta' espożizzjoni simili għal jew moderatament ogħla mil-livelli ta' espożizzjoni kliniċi kienu: bidliet fl-organi tal-limfojde fl-ispeċi kollha ttestjati, bidliet fit-transaminase,
English: Body surface area (m²)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at Month 24.
Maltese: Minn dawn, 18-il pazjent fil-linja bażi kienu fil-miri terapewtiċi stabbiliti għall volum tal-fwied u tal-milsa, livelli ta' emoglobina, u għadd tal-plejtlits, u 16-il pazjent baqgħu f'dawn il-miri terapewtiċi kollha f'Xahar 24.
English: The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Maltese: L-aktar effetti sekondarji komuni huma dijarea, gass, uġigħ addominali (fl-istonku), tnaqqis fil-piż u tnaqqis fl-aptit.
English: • There is insufficient data on Binocrit to know the size of any increased immunogenicity risk with sc use
Maltese: • Hemm informazzjoni insuffiċjenti fuq Binocrit biex ikun magħruf il-kobor ta' xi żieda fir-riskju ta' immunoġeniċità bl-użu minn taħt il-ġilda
English: Table of ADRs:
Maltese: Tabella ta' ADRs:
English: Adopted at the 5-8 March 2018 PRAC
Maltese: Adottati fil-PRAC tal-5-8 ta' Marzu 2018
English: Cefalexin - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 18911)
Maltese: 1. Cefalexin - Pustulożi esantematika ġeneralizzata akuta (AGEP)(EPITT nru 18911)
English: Norepinephrine - Stress cardiomyopathy (EPITT no
Maltese: Norepinephrine - Kardjomijopatija minn stress (EPITT nru 19172)
English: Frequency ‘not known': Stress cardiomyopathy
Maltese: Kardjomijopatija minn stress
English: Warnings and precautions - Take special care with cefalexin:
Maltese: Twissijiet u prekawzjonijiet - Oqgħod attent ħafna b'cefalexin:
English: Acute generalised exanthematous pustulosis (AGEP) has been reported with the use of cefalexin.
Maltese: Ġiet irrappurtata pustulożi esantematika ġeneralizzata akuta (AGEP) bl-użu ta' cefalexin.
English: If signs and symptoms suggestive of these reactions appear, cefalexin should be withdrawn immediately and an alternative treatment considered.
Maltese: Jekk jidhru sinjali u sintomi li jissuġġerixxu dawn ir-reazzjonijiet, cefalexin għandu jitwaqqaf minnufih u għandha tiġi kkunsidrata kura alternattiva.
English: • If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials
Maltese: • Jekk qatt żviluppajt raxx tal-ġilda jew tqaxxir tal-ġilda sever, infafet u/jew feriti fil-ħalq wara li tkun ħadt cefalexin jew antibatteriċi oħra
English: Package leaflet
Maltese: Effetti mhux mixtieqa
English: Skin and subcutaneous tissue disorders (frequency: not known) Acute generalised exanthematous pustulosis (AGEP)
Maltese: Pustulożi esantematika ġeneralizzata akuta (AGEP)
English: AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever.
Maltese: Il-post l-aktar komuni: lokalizzat prinċipalment fit-tinjiet tal-ġilda, fil-parti tan-nofs tal-ġisem u flestremitajiet fin-naħa ta' fuq.
English: A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Maltese: Raxx aħmar bil-qoxra mifrux b'boċċi taħt il-ġilda u infafet akkumpanjat minn deni fil-bidu tal-kura (pustulożi esantematika ġeneralizzata akuta).
English: If you develop a serious rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately.
Maltese: Jekk tiżviluppa raxx serju jew sintomu ieħor tal-ġilda minn dawn, ieqaf ħu cefalexin u kkuntattja lit-tabib tiegħek jew fittex attenzjoni medika immedjatament.
English: (<1/10,000) including isolated reports
Maltese: (<1/10,000) inkluż rapporti iżolati
English: 1 Vial: Suspension
Maltese: Fjala 1: Suspensjoni
English: Inactivated Bordetella pertussis 2
Maltese: Bordetella pertussis inattivat2
English: For adjuvants, see section 2.
Maltese: Għal sustanzi awżiljari, ara taqsima 2.
English: 1 adsorbed on aluminium hydroxide, hydrated
Maltese: 1 adsorbit fuq aluminium hydroxide, idratat
English: Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
Maltese: Portugal Smith Kline & French Portuguesa, Produtos
English: GlaxoSmithKline Biologicals S.A. 89 rue de I'Institut-1330 Rixensart Belgium
Maltese: GlaxoSmithKline Biologicals S.A. 89 rue de I'Institut-1330 Rixensart Il-Belġju
English: ≥ 4 IU
Maltese: ≥ 4 UI
English: 2adsorbed on aluminium phosphate
Maltese: 2adsorbit fuq aluminium phosphate
English: Liquid DTPw-HBV component:
Maltese: Komponent tad-DTPw-HBV likwidu:
English: Total: 0.26 milligrams Al3+
Maltese: Total: 0.26 milligrammi Al3+
English: Rare:
Maltese: Rari :
English: ≥ 30 IU
Maltese: ≥ 30 UI
English: 5-10 micrograms
Maltese: 5-10 mikrogrammi
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code JO7CA10
Maltese: Vaċċini batteriċi u virali kombinati, Kodiċi ATC JO7CA10
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 huwa possibbli li jista' jkun hemm reazzjonijiet ta' sensitizzazzjoni (ara sezzjoni 4.3).
English: Quintanrix was administered to approximately 1,340 healthy infants from 6 weeks of age as a primary vaccination course in several clinical trials.
Maltese: Quintanrix kien amministrat lil bejn wieħed u ieħor 1,340 tarbija b'saħħita mill-età ta' 6 ġimgħat bħala kors ta' tilqim primarju f'diversi provi kliniċi.
English: 2 doses (1 ml)
Maltese: 2 Dożi (1 ml)
English: Lyophilised HIB component:
Maltese: Komponent tal-HIB lajofilizzat:
English: • Fever (more than 37.5°C)
Maltese: • Deni (aktar minn 37.5°C)
English: Hepatitis B surface antigen (rDNA) 2, 3
Maltese: Antiġen tal-wiċċ ta' l-epatite B (rDNA) 2, 3
English: Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 2
Maltese: Polysaccharide Haemophilus influenzae tat-tip b (polyribosylribitol phosphate)
English: • Fever (more than 39°C)
Maltese: • Deni (aktar minn 39°C)
English: Diphtheria toxoid, tetanus toxoid, pertussis (whole cell):
Maltese: Toxoid tad-difterite, toxoid tat-tetnu, pertussis (ċellula sħiħa):
English: 50 x 10 doses (5 ml)
Maltese: 50 x 10 dożi (5 ml)
English: Diphtheria toxoid1
Maltese: Toxoid tad-difterite1
English: HIV infection is not considered as a contraindication.
Maltese: Infezzjoni ta' l-HIV m'hijiex meqjusa bħala kontra-indikazzjoni.
English: For this reason, the vaccinee should remain under medical supervision for at least 30 minutes.
Maltese: Għal din ir-raġuni min qed jiġi mlaqqam għandu jibqa' taħt sorveljanza medika għal millanqas 30 minuta.
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: • Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Maltese: • Biki persistenti li jdum ≥ 3 sigħat, li jiġri fi żmien 48 siegħa.
English: 100 x 2 doses (1 ml)
Maltese: 100 x 2 dożi (1 ml)
English: Powder and suspension for suspension for injection 1 Vial: Powder
Maltese: Trab u suspensjoni għal suspensjoni għall-injezzjoni Fjala 1: Trab
English: not less than 30 International Units
Maltese: mhux anqas minn 30 Unitajiet Internazzjonali
English: 2, 4, 6 months schedule N = 672
Maltese: skeda tat-2, ir-4 u s-6 xahar N = 672
English: GlaxoSmithKline Biologicals S.A. 2100 Gödöllö, Táncsics Mihály út 82 Hungary
Maltese: Gödöllö, Táncsics Mihály út 82 L-Ungerija
English: The immune response after a three-dose primary vaccination course was evaluated in five trials: 297 infants were evaluated after vaccination at 6, 10 and 14 weeks of age, 685 after vaccination at 2, 4, and 6 months of age and 107 after vaccination at 3, 4 and 5 months of age.
Maltese: Ir-rispons immuni wara kors ta' tilqim primarju ta' tliet dożi kien evalwat f'ħames provi: 297 tarbija ġew evalwati wara tilqim fl-età ta' 6, 10 u 14-il ġimgħa, 685 wara tilqim fl-età ta' 2, 4, u 6 xhur u 107 wara tilqim fl-età ta' 3, 4 u 5 xhur.
English: not less than 4 International Units
Maltese: mhux anqas minn 4 Unitajiet Internazzjonali
English: Total: 0.40 mg Al3+ 3 produced in Saccharomyces cerevisae cells by recombinant DNA technology
Maltese: Total: 0.40 mg Al3+ 3 manifatturat f'ċelluli ta' Saccharomyces cerevisiae b'teknoloġija rikombinanti tad-DNA
English: 100 x 1 dose (0.5 ml)
Maltese: 100 x doża 1 (0.5 ml)
English: At this time, the percentage of infants with anti-PRP titres ≥ 0.15 µg/ml was > 99% and the percentage with anti-HBs titres ≥ 10 mIU/ml was 97.3%.
Maltese: F'dan iż-żmien il-persentaġġ ta' trabi b'titri kontra l-PRP ≥ 0.15 µg/ml kien > 99% u l-persentaġġ b'titri konta l-HB ≥ 10 mIU/ml kien ta' 97.
English: Quintanrix is available in the following pack sizes:
Maltese: Quintanrix jinstab fil-pakketti tad-daqsijiet li ġejjin: