FrancophonIA/ELRC3.0 huggingface dataset:
English: ATP According-To-Protocol ^ gE-specific CD4[2+] T cell response = gE-specific CD4+ T cell activity, measured by intracellular cytokine staining (ICS) assay (CD4[2+] T cells = CD4+ T cells expressing at least 2 of 4 selected immune markers) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
Maltese: ^ rispons taċ-ċellula CD4[2+] T speċifiku għal gE = attività taċ-ċellula CD4+ T speċifika għal gE, imkejla minn assaġġ ta' titbigħ ta' ċitokina intraċellulari (ICS, intracellular cytokine staining) (ċelluli CD4[2+] T = ċelluli CD4+ T li jesprimu tal-inqas 2 minn 4 markaturi immuni magħżula) * Xahar 3 = xahar wara doża 2
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: ATP Skont il-Protokoll (According-To-Protocol)
English: The glycoprotein E is a protein present in the Varicella Zoster Virus.
Maltese: Il-glikoproteina E hija proteina preżenti fil-Virus Variċella Zoster.
English: Suspension
Maltese: o Sospensjoni:
English: The clinical relevance of this data is not known.
Maltese: Ir-rilevanza klinika ta' din id-data mhijiex magħrufa.
English: o Suspension: Dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate anhydrous, potassium dihydrogen phosphate and water for injections.
Maltese: Dioleoyl phosphatidylcholine, cholesterol, sodium chloride, disodium phosphate anhydrous, potassium dihydrogen phosphate u ilma għall-injezzjonijiet.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Maltese: L-istabbilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ta' 30°C.
English: For adjuvant see also section 2.
Maltese: Għall-adjuvant ara wkoll sezzjoni 2.
English: Safety and immunogenicity data on a limited number of immunocompromised subjects with human immunodeficiency virus (HIV) or haematopoietic stem cell transplant (HCT) are available (see section 5.1).
Maltese: Hemm disponibbli dejta dwar is-sigurtà u l-immunoġeniċità fuq numru limtat ta' individwi immunokompromessi b'virus tal-immunodefiċjenza umana (HIV, human immunodeficiency virus) jew bi trapjant ta' ċeluli staminali emopojetiċi (HCT, haematopoietic stem cell transplant) (ara sezzjoni 5.1).
English: Non-clinical data show that AS01B induces a local and transient activation of the innate immune system through specific molecular pathways.
Maltese: Dejta mhux klinika turi li AS01B jinduċi attivazzjoni lokali u tranżitorja tas-sistema immuni innata permezz ta' passaġġi molekulari speċifiċi.
English: Sodium dihydrogen phosphate dihydrate
Maltese: Sodium dihydrogen phosphate dihydrate Dipotassium phosphate
English: The median duration of pain medication use was 32.0 and 44.0 days in the Shingrix and placebo group, respectively.
Maltese: Id-durata medjana tal-użu tal-medikazzjoni tal-uġigħ kienet ta' 32.0 u 44.0 jum fil-grupp ta' Shingrix u tal plaċebo, rispettivament.
English: The anti-gE GMC at 1 month after the last vaccine dose was 38,153.7 mIU/ml (95% CI: 34,205.8; 42,557.3) and 44,376.3 mIU/ml (95% CI: 39,697.0; 49,607.2) following the 0, 6-month schedule and the 0, 2-month schedule, respectively.
Maltese: Il-GMC kontra gE wara xahar wara l-aħħar doża tal-vaċċin kienet 38,153.7 mIU/ml (CI ta' 95 %: 34,205.8; 42,557.3) u 44,376.3 mIU/ml (CI ta' 95 %: 39,697.0; 49,607.2) wara l-iskeda 0, 6 xhur u l-iskeda 0, xahrejn, rispettivament.
English: plant extract Quillaja saponaria Molina, fraction 21 (QS-21)
Maltese: 2 adjuvantat b'AS01B li fih: estratt tal-pjanta Quillaja saponaria Molina, frazzjoni 21 (QS-21)
English: Table 3: Humoral immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Maltese: Tabella 3: Immunoġeniċità umorali ta' Shingrix f'adulti li kellhom ≥ 50 sena (koorti ATP għallimmunoġeniċità)
English: The anti-gE GMC at 1 month after the last vaccine dose was 47,758.7 mIU/ml (95% CI: 42,258.8; 53,974.4).
Maltese: Il-GMC kontra gE wara xahar wara l-aħħar doża tal-vaċċin kienet 47,758.7 mIU/ml (CI ta' 95 %: 42,258.8; 53,974.4).
English: 3 years
Maltese: 3 LISTA
English: Antigen
Maltese: Antiġen
English: Side effects reported during clinical trials with Shingrix:
Maltese: Effetti sekondarji rrapportati matul provi kliniċi b'Shingrix:
English: • You will receive 2 injections with an interval of 2 months.
Maltese: • Inti se tirċievi 2 injezzjonijiet b'intervall ta' xahrejn.
English: The immune responses to Shingrix were evaluated in a subset of subjects from the phase III efficacy studies ZOE-50 [humoral immunity and cell-mediated immunity (CMI)] and ZOE-70 (humoral immunity).
Maltese: Ir-rispons immuni ta' Shingrix ġie evalwat f'subsett ta' individwi mill-istudji dwar l-effikaċja ta' fażi III ZOE-50 [immunità umorali u immunità medjata miċ-ċelluli (CMI)] u ZOE-70 (immunità umorali).
English: In three phase III, controlled, open-label clinical studies, adults ≥ 50 years of age were randomised to receive 2 doses of Shingrix 2 months apart administered either concomitantly at the first dose or nonconcomitantly with an unadjuvanted inactivated seasonal influenza vaccine (N=828; Zoster-004), a PPV23 vaccine (N=865; Zoster-035) or a dTpa vaccine formulated with 0.3 milligrams Al3+ (N=830; Zoster-042).
Maltese: III, ikkontrollati, open-label, adulti ta' età ta' ≥ 50 sena ġew randomizzati biex jirċievu 2 dożi ta' Shingrix xahrejn minn xulxin mogħtija jew b'mod konkomitanti bl-ewwel doża jew b'mod mhux konkomitanti b'vaċċin tal-influwenza staġjonali inattivat mhux adjuvantat ( N=828; Zoster-004), vaċċin PPV23 (N=865; Zoster-035) jew vaċċin tad-dTpa fformulat b'0.3 milligrammi
English: Shingrix is given to adults 50 years and above.
Maltese: Shingrix jingħata lill-adulti ta' 50 sena 'l fuq.
English: • itching where the injection is given (pruritus)
Maltese: • ħakk fejn tingħata l-injezzjoni (pruritu)
English: Shingrix is not indicated for prevention of primary varicella infection (chickenpox).
Maltese: Shingrix mhuwiex indikat għall-prevenzjoni tal-infezzjoni variċella primarja (ġidri r-riħ).
English: Fatigue and malaise may occur following administration (see section 4.8).
Maltese: Wara l-għoti jista' jkun hemm għeja u telqa (ara sezzjoni 4.8).
English: Very common gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain)
Maltese: Komuni ħafna sintomi gastrointestinali (inkluż nawsja, remettar, dijarea u/jew uġigħ addominali)
English: CI Confidence interval
Maltese: Twissijiet u prekawzjonijiet
English: Subjects with a history of HZ were excluded from ZOE-50 and ZOE-70.
Maltese: Individwi bi storja ta' HZ ġew esklużi minn ZOE-50 u ZOE-70.
English: Shingrix (N=7,695) or placebo (N=7,710) administered 2 months apart, - ZOE-70 (Zoster-022): 13,900 adults ≥ 70 years were randomised to receive two doses of either Shingrix (N=6,950) or placebo (N=6,950) administered 2 months apart.
Maltese: Shingrix (N=7,695) jew tal-plaċebo (N=7,710) mogħtija xahrejn minn xulxin, - ZOE-70 (Zoster-022): 13,900 adult ta' ≥ 70 sena ġew randomizzati biex jirċievu żewġ dożi ta' jew
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ GlaxoSmithKline Biologicals S.A.
English: In a phase III, uncontrolled, open-label clinical study (Zoster-033), 96 adults ≥ 50 years of age with a physician-documented history of HZ received 2 doses of Shingrix 2 months apart.
Maltese: III, mhux ikkontrollat, open-label (Zoster-033), 96 adult ta' età ta' ≥ 50 sena bi storja ta' HZ dokumentata minn tabib irċivew 2 dożi ta' Shingrix xahrejn minn xulxin.
English: Immune system disorders
Maltese: Disturi fis-sistema immuni
English: There are limited data to support the use of Shingrix in individuals with a history of HZ and in frail individuals including those with multiple comorbidities (see section 5.1).
Maltese: Hemm dejta limitata biex tappoġġja l-użu ta' Shingrix f'individwi bi storja ta' HZ u f'individwi fraġli inkluż dawk b'komorbiditajiet multipli (ara sezzjoni 5.1).
English: There were 9 reports of suspected HZ in 6 subjects over a one-year follow up period.
Maltese: Kien hemm 9 rapporti ta' HZ suspettata f'6 individwi matul perjodu ta' segwitu ta' sena.
English: Two phase I/II clinical studies, Zoster-001 and Zoster-015, were conducted in subjects with autologous hematopoietic stem cell transplant or HIV infection.
Maltese: I/II, Zoster-001 u Zoster-015, f'individwi bi trapjant taċ-ċelluli staminali emopojetiku awtologu jew b'infezzjoni tal-HIV.
English: Shingrix is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.
Maltese: Shingrix jiġi f'pakkett tad-daqs ta' kunjett 1 ta' trab flimkien ma' kunjett 1 ta' sospensjoni jew f'pakkett tad-daqs ta' 10 kunjetti ta' trab flimkien ma' 10 kunjetti ta' sospensjoni.
English: ATP According-To-Protocol ^ Anti-gE immune response = anti-gE antibody levels, measured by anti-gE enzyme-linked immunosorbent assay (gE ELISA) * Month 3 = 1 month post-dose 2 ** Month 38 = 3 years post-dose 2
Maltese: ^ rispons immuni kontra gE = livelli tal-antikorpi kontra gE, imkejla minn assaġġ ta' immunoassorbiment enzimatiku kontra gE (ELISA gE)
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' jiġi akkumpanjat minn diversi sinjali newroloġiċi bħal disturb viżiv tranżitorju, paresteżija u movimenti tad-dirgħajn u tar-riġlejn toniċi kloniċi waqt lirkupru.
English: * PHN was defined as zoster-associated pain rated as ≥3 (on a 0-10 scale), persisting or appearing more than 90 days after onset of zoster rash using Zoster Brief Pain Inventory (ZBPI) CI Confidence interval ** Over a median follow-up period of 4.1 years *** Over a median follow-up period of 4.0 years
Maltese: * PHN ġiet definita bħala uġigħ assoċjat ma' zoster ikklassifikat bħala ≥3 (fuq skala ta' 0-10), li jippersisti jew jidher aktar minn 90 jum wara l-bidu ta' raxx ta' zoster bl-użu tal-Inventarju tal-Uġigħ Qasir ta' Zoster (ZBPI, Zoster Brief Pain Inventory)
English: The efficacy in reducing BOI was 98.4% (95% CI: 92.2; 100) in subjects ≥ 50 years (ZOE-50) and 92.1% (95% CI: 90.4; 93.8) in subjects ≥ 70 years (ZOE-50 and ZOE-70 pooled).
Maltese: ≥ 50 sena (ZOE-50) u ta' 92.1 % (CI ta' 95%: 90.4; 93.8) f'individwi li kellhom ≥ 70 sena (ZOE-50 u ZOE-70 miġbura).
English: A total of 135 adults, of whom 73
Maltese: Total ta' 135 adult, li minnhom 73 kienu ta'
English: Approximately 13,000 subjects with underlying medical conditions, including conditions associated with a higher risk of HZ, were enrolled in ZOE-50 and ZOE-70.
Maltese: Madwar 13,000 individwu b'kondizzjonijiet mediċi sottostanti, inkluż kondizzjonijiet assoċjati ma' riskju ogħla ta' HZ ġew irreġistrati f'ZOE-50 u f'ZOE-70.
English: Powder and suspension for suspension for injection 1 vial: powder (antigen)
Maltese: U KONTENUT Trab u sospensjoni għal sospensjoni għall-injezzjoni kunjett 1: trab (antiġen)
English: 50 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms 3 glycoprotein E (gE) produced in Chinese Hamster Ovarian (CHO) cells by recombinant DNA technology
Maltese: 50 mikrogramma 3-O-desacyl-4'-monophosphoryl lipidu A (MPL, monophosphoryl lipid) minn Salmonella minnesota
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1272/001 - 1 vial and 1 vial EU/1/18/1272/002 - 10 vials and 10 vials
Maltese: FIS-SUQ EU/1/18/1272/001 - kunjett 1 u kunjett 1
English: 10 VIALS AND 10 VIALS
Maltese: U 10 KUNJETTI
English: Shingrix contains sodium and potassium
Maltese: Shingrix fih is-sodju u l-potassju
English: Other medicines and Shingrix
Maltese: Mediċini oħra u Shingrix
English: The median frequency of gE-specific CD4[2+] T cells was greater than 3.7-fold above baseline prevaccination median frequency.
Maltese: Ilfrekwenza medjana ta' ċelluli CD4[2+] T speċifiċi għal gE kienet akbar minn 3.7 darba mill frekwenza medjana ta' qabel it-tilqim fil-linja bażi.
English: Post-hoc analysis of efficacy against confirmed HZ undertaken in patients with common conditions (chronic kidney disease, chronic obstructive pulmonary disease, coronary artery disease, depression or diabetes mellitus), indicates that the vaccine efficacy is aligned with the overall HZ efficacy.
Maltese: ikkonfermata f'pazjenti b'kondizzjonijiet komuni (mard kroniku tal-kliewi, mard pulmonari ostruttiv kroniku, mard tal-arterja koronarja, dipressjoni jew dijabete mellitus), tindika li l-effikaċja tal-vaċċin hija simili għall-effikaċja globali tal-HZ.
English: • stomach and digestive complaints (including nausea, vomiting, diarrhoea and/or stomach pain)
Maltese: • ilmenti dwar l-istonku u d-diġestjoni (inkluż nawsja, remettar, dijarea u/jew uġigħ fl-istonku)
English: After reconstitution, 1 dose (0.5 ml) contains 50 micrograms of recombinant Varicella Zoster Virus glycoprotein E adjuvanted with AS01B
Maltese: Wara r-rikostituzzjoni, doża 1 (0.5 ml) fiha 50 mikrogramma ta' Virus Variċella Zoster glikoproteina
English: Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older (see section 5.1).
Maltese: post-herpetic neuralgia), f'adulti ta' età ta' 50 sena jew aktar (ara sezzjoni 5.1).
English: Pooled ZOE-50 and ZOE-70
Maltese: ZOE-50 u ZOE-70 miġburin
English: For intramuscular injection only, preferably in the deltoid muscle.
Maltese: Għal injezzjoni ġol-muskoli biss, preferibbilment fil-muskolu tad-deltojde.
English: Table 4: Cell-mediated immunogenicity of Shingrix in adults ≥ 50 years (ATP cohort for immunogenicity)
Maltese: Tabella 4: Immunoġeniċità medjata miċ-ċelluli ta' Shingrix f'adulti li jkollhom ≥ 50 sena (koorti ATP għal immunoġeniċità)
English: Pharmacotherapeutic group: Varicella zoster vaccines, ATC code: J07BK03.
Maltese: Vaċċini ta' variċella zoster, Kodiċi ATC:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml)
Maltese: INDIVIDWALI doża 1 (0.5 ml)
English: 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01B containing:
Maltese: E rikombinanti adjuvantat b'AS01B
English: Side effects reported after the marketing of Shingrix:
Maltese: Effetti sekondarji wara t-tqegħid fis-suq ta' Shingrix:
English: Number of PHN* cases
Maltese: każijiet ta' PHN*
English: This will maximise the protection offered by Shingrix.
Maltese: Dan se jimmassimizza l-protezzjoni offruta minn Shingrix.
English: Shingrix cannot be used to prevent chickenpox (varicella).
Maltese: Shingrix ma jistax jintuża biex jipprevjeni l-ġidri r-riħ (variċella).
English: In the pooled analysis of ZOE-50 and ZOE70, Shingrix significantly reduced these HZ-related complications by 93.7% (95% CI: 59.5; 99.9) and 91.6% (95% CI: 43.3; 99.8) in adults ≥ 50 years (1 vs. 16 cases) and adults ≥ 70 years (1 vs. 12 cases), respectively.
Maltese: ta' 95%: 59.5; 99.9) u 91.6% (CI ta' 95%: 43.3; 99.8) f'adulti li kellhom ≥ 50 sena (1 vs. 16-il każ) u f'adulti li kellhom ≥ 70 sena (1 vs. 12-il każ), rispettivament.
English: This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassiumfree'.
Maltese: Din il-mediċina fiha l-potassju, inqas minn 1 mmol (39 mg) għal kull doża, jiġifieri essenzjalment “mingħajr potassju”.
English: The evaluated HZ-related complications were: HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease, and stroke.
Maltese: Il-kumplikazzjonijiet evalwati relatati mal-HZ kienu: vaskulite tal-HZ, mard imxerred, mard oftalmiku, mard newroloġiku, mard vixxerali, u attakk ta' puplesija.
English: Shingrix significantly decreased the incidence of PHN compared with placebo in adults ≥ 50 years (0 vs. 18 cases in ZOE-50) and in adults ≥ 70 years (4 vs. 36 cases in the pooled analysis of ZOE-50 and
Maltese: ≥ 50 sena (0 vs. 18-il każ f'ZOE-50) u fl-adulti li kellhom ≥ 70 sena (4 vs. 36 każ fl-analiżi miġbura ta' ZOE-50 u ZOE-70).
English: Data from a phase II, open-label, single group, follow-up clinical study in adults ≥ 60 years (Zoster024) indicate that the vaccine-induced immune response (humoral and CMI) persists up to approximately 6 years following a 0, 2-month schedule (N= 119).
Maltese: 60 sena (Zoster-024) tindika li r-rispons immuni indott mill-vaċċin (umorali u CMI) jippersisti sa madwar 6 snin wara skeda ta' 0, xahrejn (N=119).
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Maltese: Rari (dawn jistgħu jseħħu b'massimu ta' doża 1 minn 1,000 doża tal-vaċċin)
English: The most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose;
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod frekwenti kienu uġigħ fis-sit tal-injezzjoni (68.1%
English: Confidence interval GMC Geometric Mean Concentration Q1; Q3 First and third quartiles
Maltese: N Numru ta' individwi evalwabbli fil-punt ta' żmien speċifikat Q1; Q3 L-ewwel u t-tielet kwartili
English: In subjects ≥ 70 years with at least one confirmed HZ episode (ZOE-50 and ZOE-70 pooled), Shingrix significantly reduced the use and the duration of HZ-related pain medication by 39.0% (95% CI: 11.9; 63.3) and 50.6% (95% CI: 8.8; 73.2), respectively.
Maltese: F'individwi li kellhom ≥ 70 sena b'tal-inqas episodju wieħed ta' HZ ikkonfermata (ZOE-50 u ZOE-70 miġbura), Shingrix naqqas b'mod sinifikanti l-użu u d-durata ta' medikazzjoni tal-uġigħ relatat malHZ b'39.0 % (CI ta' 95%: 11.9; 63.3) u b'50.
English: Pooled ZOE-50 and ZOE-70***
Maltese: ZOE-50 u ZOE-70*** miġburin
English: The first injection can be given from the age of 50 years onwards.
Maltese: L-ewwel injezzjoni tista' tingħata mill-età ta' 50 sena 'l fuq.
English: Uncommon lymphadenopathy
Maltese: Qabel l-immunizzazzjoni
English: How to prepare Shingrix:
Maltese: Shingrix:
English: • you have a severe infection with a high temperature (fever).
Maltese: • għandek infezzjoni severa b'temperatura għolja (deni).
English: Pooled ZOE-50 and ZOE-70**
Maltese: ZOE-50 u ZOE-70** miġburin
English: • Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).
Maltese: • Sospensjoni għal doża 1 ġo kunjett (ħġieġ tat-tip I) b'tapp (lasktu butil).
English: • Powder and suspension for suspension for injection.
Maltese: • Trab u sospensjoni għal sospensjoni għall-injezzjoni
English: • You will be informed when you should come back for the second dose of Shingrix.
Maltese: • Inti se tiġi infurmat meta għandek terġa' tmur għat-tieni doża ta' Shingrix.
English: Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Maltese: Shingrix huwa indikat għall-prevenzjoni ta' herpes zoster (HZ) u nevralġija ta' wara l-erpete (PHN,
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Shingrix in one or more subsets of the paediatric population in prevention of Varicella Zoster Virus reactivation (see section 4.2 for information on paediatric use).
Maltese: Shingrix f'wieħed jew iktar subsettijiet tal-popolazzjoni pedjatrika fil-prevenzjoni tar-riattivazzjoni tal-Virus Variċella Zoster (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: By combining the VZV specific antigen (gE) with an adjuvant system (AS01B), Shingrix is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against VZV.
Maltese: Billi l-antiġen speċifiku għall-VZV (gE) jiġi kkombinat ma' sistema ta' adjuvant (AS01B), Shingrix huwa mfassal biex jinduċi rispons immuni ċellulari u umorali speċifiku għall-antiġen f'individwi b'immunità preeżistenti kontra
English: Speak to your doctor for more information.
Maltese: Kellem littabib tiegħek għal aktar informazzjoni.
English: In a phase III, open-label clinical study (Zoster-026) where 238 adults ≥ 50 years of age were equally randomised to receive 2 doses of Shingrix 2 or 6 months apart, the humoral immune response following the 0, 6-month schedule was demonstrated to be non-inferior to the response with the 0, 2month schedule.
Maltese: III, open-label (Zoster-026) fejn 238 adult ta' età ta' ≥ 50 sena ġew randomizzati b'mod indaqs biex jirċievu 2 dożi ta' Shingrix xahrejn jew 6 xhur minn xulxin, ir-rispons immuni umorali b'segwitu tal-iskeda 0, 6 xhur intwera li ma kienx inferjuri għar-rispons bl-iskeda 0, xahrejn.
English: Shingrix can be given with the same schedule in individuals previously vaccinated with live attenuated HZ vaccine (see section 5.1).
Maltese: Shingrix jista' jingħata bl-istess skeda f'individwi li ġew imlaqqma preċedentement b'vaċċin attenwat ħaj ta' HZ (ara sezzjoni 5.1).
English: Disodium phosphate anhydrous
Maltese: Disodium phosphate anhydrous Potassium dihydrogen phosphate Ilma għall-injezzjonijiet
English: Powder and suspension for suspension for injection.
Maltese: Trab u sospensjoni għal sospensjoni għall-injezzjoni.
English: • Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
Maltese: • Trab għal doża 1 ġo kunjett (ħġieġ tat-tip I) b'tapp (lastiku butil)
English: OTHER
Maltese: CI
English: • Shingles is a rash with blisters that is often painful.
Maltese: • Shingrix jingħata bħala injezzjoni ġo muskolu (normalment fil-parti ta' fuq tad-driegħ).
English: Immunogenicity in individuals previously vaccinated with live attenuated herpes zoster (HZ) vaccine In a phase III, open-label, multicentre clinical study (Zoster-048), a 2 dose schedule of Shingrix 2 months apart was assessed in 215 adults ≥ 65 years of age with a previous history of vaccination with live attenuated HZ vaccine ≥ 5 years earlier compared to 215 matched subjects who had never received live attenuated HZ vaccine.
Maltese: Shringrix xahrejn minn xulxin f'215-il adult ta' età ta' ≥ 65 sena bi storja preċedenti ta' tilqim b'vaċċin attenwat ħaj ta' HZ ≥ 5 snin qabel meta mqabbel ma' 215-il individwu mqabbel li qatt ma kienu riċvew vaċċin attenwat ħaj ta' HZ. Ir-rispons immuni għal Shingrix ma ġiex affettwat minn tilqim preċedenti b'vaċċin attenwat ħaj ta' HZ.
English: България ГлаксоСмитКлайн ЕООД
Maltese: GlaxoSmithKline Lietuva UAB
English: Intramuscular use
Maltese: Mhux applikabbli
English: • long-lasting nerve pain - called post-herpetic neuralgia or PHN.
Maltese: L-effikaċja kontra Herpes Zoster (HZ) u Nevralġija ta' Wara l-Erpete (PHN)
English: Powder
Maltese: Wavre
English: You may be more likely to experience fever and/or shivering when 23-valent pneumococcal polysaccharide vaccine is given at the same time as Shingrix.
Maltese: Jista' jkun aktar probabbli li tesperjenza deni u/jew teritr meta vaċċin polisakkarid pnewmokokkali ta' 23-valenti jingħata fl-istess ħin ma' Shingrix.
English: Тел.
Maltese: Sími:
English: The safety and efficacy of Shingrix in children and adolescents have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Shingrix fit-tfal u fl-adolexxenti ma ġewx determinati.
English: Immunogenicity of Shingrix
Maltese: Kif jaħdem Shingrix
English: Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23) or reduced antigen diphtheria-tetanusacellular pertussis vaccine (dTpa).
Maltese: Interazzjoni ma' prodotti mediċinali oħra jew forom oħra ta' interazzjoni Shingrix jista' jingħata b'mod konkomitanti ma' vaċċin tal-influwenza staġjonali inattivat mhux adjuvantat, vaċċin polisakkarid pnewmokokkali ta' 23-valenti (PPV23) jew vaċċin antiġen imnaqqas tad-difterja-tetnu-pertussi aċellulari (dTpa, antigen diphtheria-tetanus-acellular pertussis vaccine
English: N Number of evaluable subjects at the specified time point (for the GMC) CI
Maltese: Numru ta' individwi evalwabbli fil-punt ta' żmien speċifikat (għall-GMC)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol ta' sodju (23 mg) għal kull doża, jiġifieri essenzjalment “mingħajr sodju”.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 ml) contains:
Maltese: Wara r-rikostituzzjoni, doża waħda (0.5 ml) fiha:
English: Dipotassium phosphate
Maltese: Popolazzjoni pedjatrika
English: Cholesterol
Maltese: MEDIĊINALI