FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Maltese: 6,259) jew il-plaċebo (N = 6,303), u t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħrastandard.
English: - efavirenz, or other anti-retroviral medicines (used to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer, - opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain).
Maltese: - efavirenz, jew mediċini oħra antiretrovirali (użati għat-trattament tal-infezzjonijiet mill-HIV), - carbamazepine, mediċina għat-trattament ta' xi forom tal-epilessija, - moclobemide, mediċini għat-trattament tad-dipressjoni - repaglinide, mediċina għat-trattament tad-dijabete,
English: Iscover contains lactose
Maltese: Iscover fih il-lactose
English: EU/1/98/070/008 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/009 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/010 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/012 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Maltese: EU/1/98/070/008 4x1 pilloli miksija b'rita EU/1/98/070/009 30x1 pilloli miksija b'rita EU/1/98/070/010 100x1 pilloli miksija b'rita EU/1/98/070/012 10x1 pilloli miksija b'rita
English: 6 Contents of the pack and other information What Iscover contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Iscover 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat millADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' Iscover.
English: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu tal-prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fil livell tal-metabolit attiv ta' clopidogrel Ir-rilevanza klinika ta' din l-interazzjoni hija inċerta.
English: Iscover 300 mg film-coated tablets clopidogrel
Maltese: Iscover 300 mg pilloli miksija b'rita clopidogrel
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Maltese: Metaboliżmu suċċessiv tal-metabolit intermedjarju 2-oxo-clopidogrel iwassal għall-formazzjoni tal-metabolit attiv, derivattiv thiol ta' clopidogrel. . Il metabolit attiv isir primarjament minn CYP2C19 b'kontribuzzjonijiet minn bosta enzimi CYP oħra li jinkludu CYP1A2, CYP2B6 u CYP3A4.
English: Iscover 75 mg film-coated tablets clopidogrel
Maltese: Iscover 75 mg pilloli miksijin b'rita clopidogrel
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta' inibituri qawwijin jew moderati ta' CYP2C19 għandu jiġi skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Maltese: (madwar 7-10 ijiem) u l-irkuprar tal-funzjoni normali tal-plejtlits iseħħ b'rata konsistenti malproduzzjoni ta' plejtlits.
English: - Iscover 300 mg film-coated tablets
Maltese: - Iscover 300 mg pilloli miksija b'rita
English: - Iscover 75 mg film-coated tablets
Maltese: - Iscover 75 mg pilloli miksijin b'rita
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha75 mg ta' clopidogrel (bħala hydrogen sulphate).
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Maltese: Dermatite bulloża (nekroliżi tossika ta' l epidermide, Sindromu ta' Stevens Johnson, eritema multiforme), acute generalised exanthematous pustulosis
English: Overall, 645 of 646 patients with ST-elevation-MI (STEMI) or non-ST-elevation-MI (NSTEMI) or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)).
Maltese: ST-elevation-MI) jew Infart Mijokardijaku mingħajr elevazzjoni tal-ST (NSTEMI-non-STelevation-MI) jew anġina li ma kinitx stabbli (DAPT ta' tnaqqis fil-qawwa (n=322); DAPT ta' mingħajr tibdil (n=323)).
English: EXP {MM/YYYY}
Maltese: Vistor hf.
English: Iscover 75 mg film-coated tablets
Maltese: Iscover 75 mg pilloli miksijin b'rita
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Iscover by referring to the calendar printed on the blister.
Maltese: Għall-pakketti ta' 7, 14, 28 u 84 pilloli, tista' tiċċekkja l-ġurnata li fiha ħadt l-aħħar il-pillola ta'
English: Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Maltese: Kull pillola miksija b'rita fiha 300 mg ta' clopidogrel (bħala hydrogen sulphate).
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna)
English: The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY,
Maltese: Is-sigurtà u l-effikaċja ta' clopidogrel kienu evalwati f'5 studji double blind li involvew 'il fuq minn 88,000 pazjent: fl-istudju CAPRIE, paragun ta' clopidogrel ma' ASA, u fl-istudji CURE, CLARITY, COMMIT u ACTIVE-A kienu mqabblin clopidogrel mal-plaċebo, fejn iż-żewġ prodotti mediċinali ngħataw flimkien ma' ASA u terapija oħra li soltu tingħata.
English: EU/1/98/070/011 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/013 28 film-coated tablets in all aluminium blisters EU/1/98/070/014 50x1 film-coated tablets in all aluminium blisters EU/1/98/070/015 84 film-coated tablets in all aluminium blisters EU/1/98/070/016 100 film-coated tablets in all aluminium blisters EU/1/98/070/017 30 film-coated tablets in all aluminium blisters EU/1/98/070/018 90 film-coated tablets in all aluminium blisters EU/1/98/070/019 14 film-coated tablets in all aluminium blisters EU/1/98/070/020 7 film-coated tablets in all aluminium blisters
Maltese: EU/1/98/070/013 - Kaxex ta' 28 pillola miksija b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/014 - Kaxex ta' 50x1 pilloli miksijin b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/015 - Kaxex ta' 84 pillola miksija b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/016 - Kaxex ta' 100 pillola miksija b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/017 - Kaxex ta' 30 pillola miksija b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/018 - Kaxex ta' 90 pillola miksija b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/019 - Kaxex ta' 14-il pillola miksija b'rita fil-folji kollha kemm huma tal-aluminju EU/1/98/070/020 - Kaxex ta' 7 pilloli miksija b'rita fil-folji kollha kemm huma tal-aluminju
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Maltese: Dan kien konsistenti fil-firxa ta' sottogruppi ta' pazjenti miġburaskond linja bażi ta' karatteristiċi u t-tip ta' terapija fibrinolitika jew bil-heparin.
English: What you need to know before you take Iscover Do not take Iscover:
Maltese: X'għandek tkun taf qabel ma tieħu Iscover Tiħux Iscover:
English: 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l);
Maltese: <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli). .
English: Iscover 300 mg film-coated tablets
Maltese: Iscover 300 mg pilloli miksijin b'rita
English: The active substance is clopidogrel.
Maltese: X'fih Iscover Is-sustanza attiva hi clopidogrel.
English: The prasugrel-only patients were continued on prasugrel for 11.5 months.
Maltese: Il pazjenti li kienu fuq prasugrel biss komplew fuq prasugrel għal 11.5 xhur.
English: Iscover 300 mg film-coated tablets This 300 mg tablet of clopidogrel is intended for use as a loading dose.
Maltese: Din il-pillola ta' 300 mg ta' clopidogrel hija intenzjonata għall-użu bħala doża ta' kkargar.
English: Iscover 75 mg film-coated tablets Clopidogrel should be given as a single daily dose of 75 mg.
Maltese: Clopidogrel għandu jingħata darba kuljum bħala doża ta' 75 mg.
English: Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
Maltese: (PK)/farmakodinamika (PD) f'termini ta' avvenimenti kardjovaskulari ewlenin ġew irrapportati sew mill-osservazzjoni kif ukoll mill-istudji kliniċi.
English: The median follow-up for both groups was 359 days.
Maltese: Il medjan għall-eżami ta' segwitu għaż-żewġ gruppi kien ta' 359 ġurnata.
English: Invented
Maltese: Tiżmim
English: Intravenous use vial (glass)
Maltese: Numru tal-MA (UE) Isem (ivvintat)
English: (see section 4.4)
Maltese: (ara sezzjoni 4.4).
English: 720 ELISA Units
Maltese: 720 Unitajiet ELISA
English: • multiple sclerosis
Maltese: • sklerożi multipla
English: EU/1/02/224/001 EU/1/02/224/002 EU/1/02/224/003 EU/1/02/224/004 EU/1/02/224/005
Maltese: EU/1/02/224/001 EU/1/02/224/002 EU/1/02/224/003 EU/1/02/224/004
English: month schedules were 84.8% and 92.9%, respectively.
Maltese: 8% u 92.9%, rispettivament.
English: 0.4 milligrams Al3+
Maltese: 0.4 milligrammi Al3+
English: 1 dose (1 ml)
Maltese: Doża 1 (1 ml)
English: Ambirix contains neomycin and sodium
Maltese: Ambirix fih neomycin u sodium
English: • itching (pruritus), rash
Maltese: • ħakk (prurite), raxx
English: Gastrointestinal disorders Common: gastrointestinal symptoms
Maltese: Komuni: sintomi gastrointestinali
English: Date of latest renewal: 20 July 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 30 t'Awwissu 2002 Data tal-aħħar tiġdid: 20 ta' Lulju 2012
English: • loss of appetite
Maltese: • nuqqas t'aptit
English: • You will normally have a total of two injections.
Maltese: ● Int normalment tingħata żewġ injezzjonijiet.
English: Each is given on a separate visit.
Maltese: Kull waħda tingħata fi żjara separat.
English: Pharmaco-therapeutic group: Vaccines, Hepatitis vaccines, ATC code J07BC20.
Maltese: Tilqim, Tilqim ta' l-epatite, Kodiċi ATC J07BC20.
English: Multiple sclerosis, encephalitis, encephalopathy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), myelitis, convulsions, paralysis, facial palsy, neuritis, optic neuritis, neuropathy
Maltese: Sklerozi multipla, enċefalite, enċefalopatija, polinevrite bħas-sindrome ta' Guillain-Barré (b'paraliżi li titla' 'l fuq), mijelite, aċċessjonijiet, paraliżi, paraliżi tal-wiċċ, nevrite, nevrite ottika, newropatija Disturbi vaskulari
English: Rare: arthralgia
Maltese: Rari: artlaġja
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għal injezzjoni.
English: Psychiatric disorders Very common: irritability
Maltese: Komuni ħafna: irritabilità
English: Ambirix is a turbid white suspension.
Maltese: Ambirix hija suspensjoni bajda imdardra.
English: EU/1/02/224/001 - pack of 1 without needle EU/1/02/224/002 - pack of 1 with 1 needle EU/1/02/224/003 - pack of 10 without needle EU/1/02/224/004 - pack of 10 with 10 needles EU/1/02/224/005 - pack of 50 without needle
Maltese: EU/1/02/224/003 - pakkett ta' 10 mingħajr labar EU/1/02/224/004 - pakkett ta' 10 b'10 labriet EU/1/02/224/005 - pakkett ta' 50 mingħajr labar
English: Ambirix is for intramuscular injection, usually into the deltoid muscle.
Maltese: Ambirix għandu jingħata bħala injezzjoni ġol-muskolu, normalment fil-muskolu deltojd.
English: Other medicines and Ambirix
Maltese: Mediċini oħra u Ambirix
English: Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Maltese: Fl-istudji kliniċi ngħataw 2029 doża ta' Ambirix lil 1027 individwu ta' l-etajiet ta' bejn sena u 15-il sena, din ta' l-aħħar inkluża.
English: Seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
Maltese: Ir-rati ta' seroposittività għall-anti-HAV kienu ta' 99.0% u r-rati ta' seropositività għall-anti-HBs kienu ta' 99.0% fix-xahar numru 13 b'rati ta' seroprotezzjoni ta' 97.0%.
English: • inflammation of the nerves (neuritis)
Maltese: • infjammazzjoni tan-nervaturi (nevrite)
English: Very rare: urticaria
Maltese: Rari ħafna: urtikarja
English: This medicinal product contains less than 1 mmol sodium (9 mg) per dose, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (9 mg) f'kull doża, i.e. essenzjalment ‘mingħajr sodium'.
English: Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Maltese: Magħmul fuq ċelluli diplojdi (MRC-5) umani Adsorbit fuq aluminium hydroxide, idratat
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects aged 1-11 years or 12-15 years at the time of the first dose were 77.3% and 85.9%, respectively.
Maltese: Il-perċentwali b'antikorp anti-HBs ta' ≥10 mIU/ml f'dan iż-żmien għal individwi li għandhom minn 1-11-il sena jew li kellhom bejn 12-15-il sena meta ngħataw l-ewwel doża kienu 77.3% u 85.9%, rispettivament.
English: BATCH NUMBER
Maltese: Xahar numru 7
English: The anti-HBs seroprotection rates (titers ≥ 10 mlU/ml) at these time points were 37.4% and 98.2% respectively.
Maltese: F'dan iż-żmien ir-rati ta' seroprotezzjoni għall-anti-HBs (titri ≥ 10 mlU/ml ) kienu ta' 37.4% u 98.2% rispettivament.
English: This vaccine contains neomycin (an antibiotic).
Maltese: Dan il-vaċċin fih neomycin (antibijotiku).
English: • Clinical trial data
Maltese: • Dejta minn prova klinika
English: 6-11 yrs old
Maltese: Etajiet minn 6-11 ilsena
English: A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Maltese: Doża ta' 1.0 ml hija rakkomandata f`individwi mill-eta' ta' sena sa 15-il sena, ta' l-aħħar inkluża.
English: This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
Maltese: Din id-differenza ma tibqax tidher wara tteħid tat-tieni doża ta' Ambirix (ara sezzjoni 5.1 dwar r-rati ta' seroprotezzjoni)
English: 10 x 1 dose (1 ml)
Maltese: 10 x doża waħda (1 ml)
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (1 ml)
Maltese: 10 siringi mimlija għal-lest + 10 labriet 10 x doża waħda (1 ml)
English: Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and antiHBs antibodies.
Maltese: Ambirix jagħti immunità kontra l-infezzjoni ta' l-HAV u l-HBV billi jinduċi antikorpi speċifiċi antiHAV u anti-HBs.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or neomycin.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, jew għal neomycin.
English: How the injection is given
Maltese: Infezzjonijiet u infestazzjonijiet
English: Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus
Maltese: Eritema multiforme, lichen planus
English: In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
Maltese: Sar studju kliniku ta' paragun fuq individwi ta` etajiet ta' bejn it-12 u l-15-il sena, ta' l-aħħar inkluża, fejn 142 irċevew żewġ dożi ta'Ambirix u 147 irċevew it-tilqim standard bi tliet dożi kombinati.
English: Symptoms begin 3 to 6 weeks after infection.
Maltese: Sintomi jibdew minn 3 sa 6 ġimgħat wara l-infezzjoni.
English: At 6 years following the initiation of a 0, 6 month or a 0, 12 month schedule of Ambirix in children aged 12-15 years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody.
Maltese: Fis-6 sena mill-bidu ta' skeda ta' għoti ta'Ambirix fix-xhur 0, 6 jew ta' 0, 12 fi tfal li għandhom bejn 12-15-il sena l-individwi kollha segwiti żammew livell ta' ≥15 mIU/ml ta' antikorp anti-HAV.
English: 6.4 Special precautions for storage Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: 1-5 yrs old
Maltese: Etajiet minn 1-5 snin Ambirix
English: • aching muscles (myalgia)
Maltese: • uġigħ fil-muskoli (majalġja)
English: Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection.
Maltese: Ambirix huwa indikat għal tfal u adoloxxenti mhux immuni b'età minn sena sa 15-il sena, ta' l-aħħar inkluża, għall-protezzjoni kontra l-infezzjoni ta' l-epatite A u l-epatite B.
English: Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia
Maltese: Purpura tromboċitopenika, tromboċitopenija
English: The vaccine has not been tested in patients with an impaired immune system.
Maltese: It-tilqima ma ġietx ittestjata f'pazjenti li għandhom problemi fis-sistema immuni.
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 tista' ġġiegħel il-fwied jintefaħ (jifjamma).
English: The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Maltese: L-antiġen tal-wiċċ ta' kontra l-epatite B (anti-HBs) u t-titri ta' l-antikorpi tal-virus ta' kontra l-epatite A (anti-HAV) li kienu osservati wara kors primarju ta' tilqim bl-Ambirix huma fil-marġini ta' dak li jidher wara t-tilqim bil-vaċċini ta' l-epatite A u B monovalenti.
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 tarriġlejn u d-dirgħajn matul l-irkupru.
English: It is not known exactly how long protection against infection with hepatitis A and B viruses will last, although protection against the hepatitis A virus probably lasts about 10 years.
Maltese: Mhux magħruf eżatt kemm iddum il-protezzjoni kontra infezzjoni mill-virusis tal-epatite A u B, għalkemm protezzjoni kontra l-virus tal-epatite A probabbilment idum madwar 10 snin.
English: Ambirix may need to be given at the same time as other vaccines for measles, mumps, rubella, diphtheria, tetanus, whooping cough (pertussis), poliomyelitis, Haemophilus influenzae type b or some types of treatments for hepatitis infections called “immunoglobulins”.
Maltese: Ambirix jista' jeħtieġ li jingħata fl-istess żmien ma' vaċċini oħra għall-ħożba, ġidri, rubella difterite, tetnu, sogħla konvulsiva (pertussis), poljomelite, Haemophilus influenzae tat-tip b jew xi tipi ta' kura għall-infezzjonijiet tal-epatite imsejħa “immunoglobulini”.
English: In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e month 7).
Maltese: Fi studji kliniċi li involvew individwi mill-età ta' sena sa 15-il sena,ta' l-aħħar inkluża, ir-rati ta' seropositività għall-antikorpi, anti-HAV kienu ta' 99.1%, xahar wara l-ewwel doża u 100% wara ttieni doża li ngħatat fix-xahar numru 6 (jiġifieri fis-7 xahar).
English: Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Maltese: Reazzjonijiet avversi lokali u ġenerali li ġew rappurtati wara tilqim primarju b'Ambirix ġew klassifikati skond il-frekwenza.
English: • Store in the original package in order to protect from light.
Maltese: • Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-Suq.
English: In a clinical study, 102 subjects aged from 12 years up to and including 15 years received the second dose of Ambirix at month 12.
Maltese: Fi studju kliniku li sar fuq 102 individwi ta`etajiet ta' bejn it-12 u l-15-il sena,ta' l-aħħar inkluża, ngħataw it-tieni doża ta' Ambirix fix-xahar numru 12.
English: When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1).
Maltese: Meta Ambirix ingħata flimkien, iżda bħala injezzjoni separata, ma' vaċċin kombinat kontra ddifterite, tetnu, pertussis aċellulari, poljomelite inattivat u Haemophilus influenzae tat-tip b (DTPaIPV+Hib) jew ma' vaċċin kombinat kontra l-Ġidri, Ħożba u Rubella fit-tieni sena mit-twelid, irrispons immuni għall-antiġeni kollha kien sodisfaċenti (ara sezzjoni 5.1)
English: Ambirix should not be given if you are allergic to neomycin.
Maltese: Ambirix m'għandux jingħata jekk inti allerġiku/a għal neomycin.
English: • purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Maltese: • ponot vjola jew ħomor fil-vjola mqabbżin fil-ġilda (lichen planus), raxx serju fil-ġilda (eritema multiforme)
English: For some categories of subjects at risk of exposure to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥ 10 mIU/ml is maintained.
Maltese: Għal xi kategoriji ta' individwi esposti għal riskju ta' HBV (e.g. pazjenti fuq dijaliżi tad-demm jew pazjenti immunokompromessi) trid tittieħed attitudni ta' prekawzjoni biex ikun żgurat li jinżamm livell ta' antikorpi protettiv ta' ≥ 10 mUI/ml.
English: • Official batch release
Maltese: • pressjoni baxxa
English: 10 pre-filled syringes
Maltese: • tħossok stordut
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12
Maltese: Ilperċentwali b'antikorp anti-HBs ta' ≥10 mIU/ml f'dan iż-żmien għal individwi li tlaqqmu bi skedi ta' 0, 6 u 0, 12-il xahar kienu 84.
English: GlaxoSmithKline s.r.o.
Maltese: GlaxoSmithKline S.p.A.
English: The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Maltese: Din ta` l-aħħar kien fiha 360 Unitajiet ELISA tal-virus ta' l-epatite A inattivat bil-formalina u 10 mikrogrammi ta' l-antiġen tal-wiċċ ta' l-epatite B rikombinanti.
English: • The other ingredients in Ambirix are: sodium chloride and water for injections.
Maltese: • Is-sustanzi l-oħra ta' Ambirix huma: sodium chloride u ilma għall-injezzjonijiet.
English: 1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Maltese: 1 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ tat-tip I) magħluqa bi planġer (lastku butyl).