FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another study as add-on to a sulphonylurea.
Maltese: Fi studju kliniku ta' alogliptin bħala monoterapija, l-inċidenza ta' ipogliċemija kienet simili għal dik tal-plaċebo, u inqas minn plaċebo fi studju ieħor bħala aġġuntiv ma' sulphonylurea.
English: NAME OF THE MEDICINAL PRODUCT Vipidia 25 mg tablets alogliptin
Maltese: Vipidia 25 mg pilloli miksija b'rira alogliptin
English: Common (may affect up to 1 in 10 people): - Symptoms of low blood sugar (hypoglycaemia) may occur when Vipidia is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Maltese: • jekk qed tieħu mediċina antidijabetika magħrufa bħala sulphonylurea (eż. glipizide, tolbutamide, glibenclamide) jew insulina.
English: The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Maltese: Iż-żieda ta alogliptin 25 mg darba kuljum ma' terapija b'metformin hydrochloride (doża medja = 1,847 mg) irriżultat f'titjib statistikament sinifikanti mil-linja bażi fl-HbA1c u fil-glukosju fil-plażma wara s-sawm f'Ġimgħa 26 meta mqabbel maż-żieda ta' plaċebo (Tabella 2).
English: Clinically meaningful reductions in HbA1c compared to control were also observed with 25 mg alogliptin regardless of baseline background treatment.
Maltese: Tnaqqis klinikament sinifikanti fl-HbA1c meta mqabbel mal-kontroll kien ukoll osservat b'alogliptin 25 mg irrispettivament minn trattament fl-isfond tal-linja bażi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
Maltese: FIS-SUQ Takeda
English: Placebo-corrected change from baseline in HbA1c (%)†
Maltese: Bidla mil-linja bażi kkoreġuta bi plaċebo f'HbA1c (%)†
English: When the 4-hour postprandial glucose concentrations were averaged across breakfast, lunch and dinner, 14 days of treatment with 25 mg alogliptin resulted in a mean placebo-corrected reduction from baseline of -35.2 mg/dL.
Maltese: Meta ttieħdet il-medja tal-konċentrazzjonijiet ta' glukosju 4 sigħat mit-teħid ta' ikel tal-kolazzjon, ikla ta' nofsinhar u ta' filgħaxija, għal 14-il jum ta' kura b'alogliptin 25 mg irriżulta tnaqqis medju kkoreġut bi plaċebo mil-linja bażi ta' -35.2 mg/dL.
English: Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side.
Maltese: Pilloli miksija b'rita ta' lewn roża ċar, f'għamla ovali (madwar 9.1 mm twal u 5.1 mm wiesgħa), imżaqqin fuq iż-żewġ naħat b'“TAK” u “ALG-6.25” stampati b'linka griża fuq naħa waħda.
English: Alogliptin as add-on therapy to a sulphonylurea
Maltese: Tfal u adolexxenti
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate).
Maltese: Kull pillola fiha 25 mg alogliptin (bħala benzoate)
English: Following a single intravenous dose of 12.5 mg alogliptin to healthy subjects, the volume of distribution during the terminal phase was 417 L indicating that the active substance is well distributed into tissues.
Maltese: Wara doża waħda ta' alogliptin 12.5 mg ġol-vini lil individwi b'saħħithom, il-volum ta' distribuzzjoni matul il-fażi terminali kien ta' 417 L li jindika li s-sustanza attiva ġiet imferrxa tajjeb fit-tessut.
English: Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session).
Maltese: Ammonti minimi ta' alogliptin huma mneħħija bl-emodijalisi (madwar 7% tas-sustanza tneħħiet matul sessjoni ta' emodijaliżi ta' 3 sigħat).
English: These studies evaluated the effects of alogliptin on glycaemic control and its safety as monotherapy, as initial combination therapy with metformin or a thiazolidinedione, and as add-on therapy to metformin, or a sulphonylurea, or a thiazolidinedione (with or without metformin or a sulphonylurea), or insulin (with or without metformin).
Maltese: Dawn l-istudji evalwaw l-effetti ta' alogliptin dwar il-kontroll gliċemiku u s-sigurtà tiegħu bħala monoterapija, bħala kombinazzjoni inizjali ma' metformin jew thiazolidinedione, u bħala terapija aġġuntiva ma' metformin, jew sulphonylurea, jew thiazolidinedione (bi jew mingħajr metformin jew sulphonylurea), jew insulina (bi jew mingħajr metformin).
English: In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat jew sever, jew mard tal kliewi fl-aħħar stadju fuq emodijalisi, żieda fl-esponiment sistemiku għal alogliptin ta' madwar 2 u 4 darbiet kienet osservata, rispettivament.
English: Your doctor may want to reduce your dose of sulphonylurea or insulin when you take any of them together with Vipidia in order to avoid too low blood sugar (hypoglycaemia) - if you have kidney disease, you can still take this medicine but your doctor may reduce the dose - if you have liver disease - if you suffer from heart failure - if you are taking insulin or an anti-diabetic medicine, your doctor may want to reduce your dose of the other anti-diabetic medicine or insulin when you take either of them together with Vipidia in order to avoid low blood sugar - if you have or have had a disease of the pancreas
Maltese: It-tabib tiegħek għandu mnejn ikun jixtieq inaqqas id-doża tiegħek ta' sulphonylurea jew insulina meta tieħu xi waħda minnhom flimkien ma' Vipidia sabiex jiġi evitat li l-livell ta' zokkor jitbaxxa wisq (ipogliċemija)
English: As a precautionary measure, it is preferable to avoid the use of alogliptin during pregnancy.
Maltese: Bħala prekawzjoni hu preferribli li ma jintużax alogliptin waqt it-tqala.
English: Skin and subcutaneous tissue disorders pruritus common rash common exfoliative skin conditions including Stevens-Johnson syndrome erythema multiforme not known not known angioedema not known urticaria not known
Maltese: Għalkemm il-fertilità ma kinitx affettwata, żieda statistika żgħira ta' sperma anormali ġiet osservata fl-irġiel f'esponiment ferm ogħla mill-esponiment tal-bniedem fid-doża rrakkomandata.
English: The pharmacokinetics of alogliptin has been shown to be similar in healthy subjects and in patients with type 2 diabetes mellitus.
Maltese: Il-farmakokinetika ta' alogliptin ġiet murija li hija simili f'individwi b'saħħithom u f'pazjenti b'dijabete mellitus ta' tip 2.
English: Microcrystalline cellulose
Maltese: Kif taħżen Vipidia
English: It is available as tablets (150 mg aliskiren and 12.5 mg hydrochlorothiazide; 150 mg aliskiren and 25 mg hydrochlorothiazide; 300 mg aliskiren and 12.5 mg hydrochlorothiazide; 300 mg aliskiren and 25 mg hydrochlorothiazide).
Maltese: Tiġi bħala pilloli (150 mg aliskiren u 12.5 mg idroklorotijażid; 150 mg aliskiren u 25 mg idroklorotijażid; 300 mg aliskiren u 12.5 mg idroklorotijażid; 300 mg aliskiren u 25 mg idroklorotijażid).
English: The full EPAR for Riprazo HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Aliskiren is a renin inhibitor.
Maltese: Aliskiren huwa inibitur tar-renin.
English: EPAR summary for the public aliskiren / hydrochlorothiazide
Maltese: Sommarju tal-EPAR għall-pubbliku aliskiren / idroklorotijażid
English: Aliskiren on its own has been authorised in the European Union (EU) since August 2007 as Rasilez, Sprimeo and Riprazo.
Maltese: Aliskiren weħidha ilha tiġi awtorizzata fl-Unjoni Ewropea (UE) sa minn Awwissu 2007 bħala Rasilez, Sprimeo u Riprazo.
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Maltese: Huwa jimblokka l-attività ta' enzima umana msejħa renin, li hija involuta fil-produzzjoni ta' sustanza fil-ġisem imsejħa anġjotensina I.
English: This is a summary of the European public assessment report (EPAR) for Riprazo HCT.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Riprazo HCT.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Riprazo HCT on 13 April 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Riprazo HCT fit-13 ta' April 2011.
English: Riprazo HCT contains two active substances, aliskiren and hydrochlorothiazide.
Maltese: Riprazo HCT fih żewġ sustanzi attivi, l-aliskiren u l-idroklorotijażid.
English: The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
Maltese: L-istudji qabblu l-kombinazzjoni tal-aliskiren u l-idroklorotijażid ma' plaċebo (kura finta), mal-aliskiren jew mal-idroklorotijażid meħudin weħidhom, jew ma' mediċini oħrajn għall-ipertensjoni (il-valsartan, l-irbesartan, il-lisinopril jew lamlodipina).
English: What is Riprazo HCT?
Maltese: X'inhuwa Riprazo HCT?
English: This authorisation was based on the authorisation of Rasilez HCT in 2009 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni ta' Rasilez HCT fl-2009 (‘kunsens informat').
English: Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension.
Maltese: B'kollox il-kumpanija ppreżentat ir-riżultati minn disa' studji ewlenin li fihom ħadu sehem total ta' kważi 9,000 pazjent b'ipertensjoni essenzjali.
English: Riprazo HCT is a medicine that contains the active substances aliskiren and hydrochlorothiazide.
Maltese: Riprazo HCT hija mediċina li fiha s-sustanzi attivi aliskiren u idroklorotijażid.
English: Riprazo HCT in combination with an ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Riprazo HCT ma għandux jintuża flimkien ma' ‘inibituri ta' enzimi li jikkonvertu l-anġjotensini' (ACE) jew ‘imblokkaturi tar-riċetturi tal-anġjotensini' (ARBs) f'pazjenti bid-dijabete, jew b'indeboliment renali moderat jew sever.
English: Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
Maltese: Ħafna mill-istudji involvew pazjenti b'ipertensjoni minn ħafifa sa moderata u wieħed involva pazjenti b'ipertensjoni severa.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: L-anġjotensina I tiġi kkonvertita fl-ormon anġjotensina II, li huwa vasokonstrittur qawwi (sustanza li ddejjaq l-arterji u l-vini).
English: The company presented information used in the assessment of aliskiren and from the published literature to support its application for Riprazo HCT, as well as information from additional studies.
Maltese: Il-kumpanija ppreżentat informazzjoni użata fil-valutazzjoni tal-aliskiren u millitteratura ppubblikata biex tappoġġa l-applikazzjoni tagħha għal Riprazo HCT, kif ukoll informazzjoni minn studji addizzjonali.
English: It must not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Maltese: Ma għandux jittieħed maċ-ċiklosporina, mal-itrakonażolu, jew ma' mediċini oħra magħrufa bħala ‘inibituri qawwija ta' P-glycoprotein' (bħal quinidine).
English: What is the risk associated with Riprazo HCT?
Maltese: X'inhu r-riskju assoċjat ma' Riprazo HCT?
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Maltese: Billi timblokka l-produzzjoni tal-anġjotensina I, kemm il-livelli tal-anġjotensina I kif ukoll il-livell talanġjotensina II jonqsu.
English: Other information about Riprazo HCT
Maltese: Tagħrif ieħor dwar Riprazo HCT
English: Riprazo HCT must not be used in people who are hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulfonamides.
Maltese: Riprazo HCT ma għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għall-aliskiren, għallidroklorotijażid, għal xi wieħed mis-sustanzi l-oħra jew għas-sulfamidiċi.
English: The most common side effect with Riprazo HCT (seen in between 1 and 10 patients in 100) is diarrhoea.
Maltese: L-effett sekondarju l-aktar komuni b'Riprazo HCT (li deher f'bejn pazjent 1 u 10 pazjenti minn kull 100) hija d-dijarea.
English: How has Riprazo HCT been studied?
Maltese: Kif ġie studjat Riprazo HCT?
English: 720 ELISA Units
Maltese: 720 ELISA Unit
English: For adjuvants, see section 2.
Maltese: Għal sustanzi awżiljari, ara sezzjoni 2.
English: Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Maltese: Enkefalite, enkefalopatija, newrite, newropatija, paraliżi, aċċessjonijiet
English: Uncommon Myalgia Rare
Maltese: Mhux komuni Majalġja Rari
English: Hepatitis A
Maltese: Epatite A
English: Date of latest renewal: 28 August 2006
Maltese: Data tal-aħħar tiġdid: 28 ta' Awwissu 2006
English: Hepatitis A virus (inactivated)1,2
Maltese: Virus tal-epatite A (inattivat)1,2
English: Hypoaesthesia, paraesthesia
Maltese: Ipoestesija, parasteżija
English: Hepatitis B surface antigen3,4
Maltese: Antiġen tas-superfiċje ta' l-epatite B3,4
English: EU/1/96/020/001 - pack of 1 without needle EU/1/96/020/002 - pack of 10 without needle EU/1/96/020/003 - pack of 25 without needle EU/1/96/020/007 - pack of 1 with 1 needle EU/1/96/020/008 - pack of 10 with 10 needles EU/1/96/020/009 - pack of 25 with 25 needles
Maltese: EU/1/96/020/001 - pakkett ta' 1 mingħajr labra EU/1/96/020/002 - pakkett ta' 10 mingħajr labra EU/1/96/020/003 - pakkett ta' 25 mingħajr labra EU/1/96/020/007 - pakkett ta' 1 b'labra 1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 1996
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 1996
English: The HA virus is propagated in MRC5 human diploid cells.
Maltese: Il-virus HA huwa ppropagat f'ċelluli umani tat-tip diploid MRC5.
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Maltese: • Epatite B: L-epatite B hija kawżata mill-virus tal-epatite B.
English: 0.05 milligrams Al3+
Maltese: 0.05 milligrammi A13+
English: • Inflammation of nerves (neuritis)
Maltese: • Infjammazzjoni tan-nervituri (newrite)
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Maltese: 1Manifatturat fuq ċelluli umani tat-tip diploid (MRC-5) 2Adsorbit fuq aluminium hydroxide, idratat
English: The seroprotection rate against hepatitis B after the administration of Twinrix Adult was 92% and 56% at 7 and 48 months respectively, versus 80% and 43% after the GlaxoSmithKline Biologicals monovalent 20µg hepatitis B vaccine, and 71% and 31% after another licensed monovalent 10µg hepatitis B vaccine.
Maltese: Ir-rata ta' seroprotezzjoni għal-epatite B wara li ngħatat Twinrix Adult kienet ta' 92% u 56% fix-xhur 7 u 48 rispettivament, kontra rata ta' 80% u 43% għal vaċċin indipendenti għal-epatite B ta' 20µg ta' GlaxoSmithKline Biologicals, u 71% u 31% wara vaċċin indipendenti ieħor awtoriżżat għal-epatite B ta'
English: Angioneurotic oedema, lichen planus, erythema multiforme
Maltese: Edema anġjonewrotika, lichen planus, eritema multiforme
English: 0.4 milligrams Al
Maltese: 0.4 milligrammi A1
English: Twinrix Adult is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Maltese: Twinrix Adult huwa vaċċin kombinat ifformulat billi jinġemgħu preparazzjonijiet fuq skala kbira tal-virus tal-epatite A (HA) ippurifikat u inattivat u l-antiġenu ta' barra tal-epatite B ippurifikat (HbsAg), separatament adsorbiti fuq aluminium hyroxide u aluminium phosphate.
English: 0.4 milligrams Al3+
Maltese: 0.4 milligrammi A13+
English: In two long term clinical studies conducted in adults aged 17 years to 43 years, 56 subjects had evaluable tests 15 years after the primary vaccination with Twinrix Adult; the anti-HAV seropositivity rates were 100% in both studies and the anti-HBs seroprotection rates were 89.3% and 92.9%, respectively.
Maltese: F' żewġ studji kliniċi meħudha fit-tul fl-adulti ta'17-il sena sa 43 sena, 56 individwu kellhom testijiet evalwabbli 15-il sena wara l-ewwel tilqima bi Twinrix Adult; ir-rati ta' seroposittività anti-HAV kienu 100% fiż-żewġ studji u r-rati ta' seroprotezzjoni anti-HBs kienu ta' 89.3% u 92.9%, rispettivament.
English: Obesity (defined as BMI ≥ 30 kg/m2) has been observed to reduce the immune response to hepatitis A vaccines.
Maltese: Ġie osservat li l-obeżità (definita bħala BMI ≥ 30 kg/m2) tnaqqas ir-rispons ta' l-immunità għall-vaċċini ta'
English: b. If the vaccine still does not appear as a uniform hazy white suspension - tip upside down and back again for at least another 15 seconds - then inspect again.
Maltese: Jekk il-vaċċin ikun għadu ma jidhirx bħala suspensjoni bajda mċajpra uniformi - aqilbu rasu l-isfel u lura għal mill-anqas 15-il sekonda oħra - imbagħad erġa' spezzjona.
English: Seropositivity rates for anti-HAV antibodies were 100%, 99.5% and 100% at months 1, 2 and 3 after the initial dose.
Maltese: Rati ta'seroposittivita' tal-antikorpi kontra l-epatite A kienu ta'100%, 99.5% u 100% fl-1,2,3 xahar mit teħid ta' l-ewwel doża.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jkun akkompanjat minn diversi sinjali newroloġiċi bħal disturbi transitorji fil-vista, parasteżija u movimenti toniċi-kloniċi tar-riġlejn u d-dirgħajn matul l-irkupru.
English: 1 dose (1 ml)
Maltese: Doża 1(1 ml)
English: A dose of 1.0 ml is recommended for adults and adolescents 16 years of age and above.
Maltese: Doża ta'1.0 millilitru hija rakkomandata għal Adulti u adoloxxenti ta' l-fuq minn 16 il-sena.
English: Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis
Maltese: Sklerożi multipla, majelite, palsija tal-wiċċ, polinewrite bħall-marda ta' Guillain-Barre (b'paraliżi li titla 'l fuq),
English: 25 pre-filled syringes + 25 needles 25 x 1 dose (1 ml)
Maltese: 25 siringi mimlijin għal-lest + 25 labra 25 x doża 1 (1 ml)
English: The most commonly reported adverse reactions following Twinrix Adult administration with the standard 0, 1, 6 month schedule are pain and redness occurring in a per dose frequency of 37.6% and 17.0% respectively.
Maltese: Ir-reazzjonijiet avversi rrappurtati b'mod komuni wara l-għoti ta' Twinrix Adult mal iskeda standard ta' 0, 1, 6 xhur huma uġigħ u ħmura li jseħħu f'kull doża b'frekwenza ta' 37.6% u 17.0%
English: • Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
Maltese: • Reazzjonijiet allergiċi serji (anafilassi, reazzjonijiet allergiċi simili għal attakk anafilattiku u li jixbħu serum sickness).
English: Pharmaco-therapeutic group: Hepatitis vaccines, ATC code: J07BC20.
Maltese: Kategorija farmakoterapewtika: vaċċini tal-epatite, Kodiċi ATC:
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 ta' tip I) b'tapp tal-planġer (lastiku butyl).
English: Pack sizes of 1, 10 and 25 with or without needles.
Maltese: Daqs tal-pakketti ta' 1, 10 u 25 bi jew mingħajr labar.
English: - The other ingredients in Twinrix Adult are: sodium chloride, water for injections.
Maltese: - Is-sustanzi l-oħra fi Twinrix Adult huma: sodium chloride, ilma għall-injezzjonijiet
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (1 ml)
Maltese: 10 siringi mimlijin għal-lest + 10 labar 10 x doża 1 (1 ml)
English: The safety profile presented below is based on a pooled analysis of events per dose from more than 6,000 subjects who received either the standard 0, 1, 6 month schedule (n=5,683) or the accelerated 0, 7, 21 days schedule (n=320).
Maltese: Il-profil ta' sigurtà ppreżentat hawn taħt huwa bbażat fuq analiżi miġbura ta' effetti wara kull doża f'aktar minn 6,000 suġġett li ħadu l-iskeda standard ta' 0, 1, 6 xhur (n=5,683) jew l-iskeda aċċelerata ta' 0, 7, 21 ġurnata (n=320).
English: • Dizziness
Maltese: • Aċċessjonijiet
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Maltese: 3Manifatturat fuq ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA 4Adsorbit fuq aluminium phosphate
English: In a clinical study conducted in subjects over 40 years of age, the seropositivity rate for anti-HAV antibodies and seroprotection rate against hepatitis B of Twinrix Adult following a 0, 1, 6 months schedule were compared with the seropositivity and seroprotection rates of monovalent hepatitis A and B vaccines when administered in opposite arms.
Maltese: F'studju kliniku li sar f'suġġetti ta' fuq l-erbgħajn sena, r-rata ta'seroposittivita' tal-antikorpi anti-HAV u rrata ta' seroprotezzjoni għal-epatite B ta' Twinrix Adult, wara skeda ta' 0,1,6 xhur ġew imqabbla ma' r-rati ta'seroposittivita' u ta' seroprotezzjoni ta' vaċċini indipendenti kontra l-epatite A u l-epatite B meta dawn ingħataw f'gruppi opposti.
English: In the two clinical trials in which Twinrix Adult was administered at 0, 7, 21 days, overall solicited general and local symptoms were reported with the same categories of frequency as defined below.
Maltese: Fiż-żewġ provi kliniċi fejn Twinrix Adult ingħata fi żmien 0, 7, 21 ġurnata, s-sintomi ġenerali u lokali dokumentati ġew irrapurtati bl-istess kategoriji ta' frekwenza kif definit hawn taħt.
English: Twinrix Adult is available in packs of 1, 10, and 25 with or without needles.
Maltese: Twinrix Adult jinsab f'pakketti ta' 1, 10 jew 25 bil-labar jew mingħajrhom.
English: How to store Twinrix Adult
Maltese: Tiħux Twinrix Adult jekk:
English: - Keep this leaflet.
Maltese: - Doża ta' rinforz.
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 wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1 jew neomycin.
English: Thrombocytopenia, thrombocytopenic purpura
Maltese: Meninġite Disturbi tad-demm u tas-sistema limfatika Tromboċitopenja, purpura tat-tromboċitopenja
English: Tlf: + 47 22 70 20 00
Maltese: GlaxoSmithKline AS Tlf: + 47 22 70 20 00
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-suq u l-Manifattur GlaxoSmithKline Biologicals s.a.
English: Other medicines and Twinrix Adult
Maltese: Kif taħżen Twinrix Adult
English: Arthritis, muscular weakness
Maltese: Artrite, dgħjufija fil-muskoli
English: Sodium chloride
Maltese: Sodium Chloride Ilma għall-injezzjonijiet
English: • Degenerative disease of the brain (encephalopathy)
Maltese: • Mard deġenerattiv tal-moħħ (enkefalopatija)
English: Tel: +372 667 6900 estonia@gsk.com
Maltese: GlaxoSmithKline Eesti OÜ Tel: +372 667 6900 estonia@gsk.com
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni
English: Twinrix Adult, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Maltese: Vaċċin (adsorbit) tal-epatite A (inattivat) u epatite B (rDNA) (HAB)
English: Long-term antibody persistence data following vaccination with Twinrix Adult are available up to 15 years after vaccination.
Maltese: Hemm informazzjoni fuq il-persistenza tal-antikorp wara tilqima bi Twinrix Adult sa 15-il sena wara t tilqima.