FrancophonIA/ELRC3.0 huggingface dataset:
English: In the female and black subgroups which represented 32 % and 26 % of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Maltese: Għal punt ta' riferiment sekondarju każijiet kardjovaskulari fatali u mhux fatali, ma dehret kienx hemm differenza bejn it-tliet gruppi ta' pazjenti fil-popolazzjoni totali, għalkemm inċidenza akbar ta' indar mijokardjaku mhux fatali ġiet murija fin-nisa u inċidenza inqas ta' MI mhux fatali ġiet murija f'irġiel fil-grupp t'irbesartan kontra l-grupp msejjes fuq programm ta' plaċebo.
English: The pharmacokinetics of irbesartan were evaluated in 23 hypertensive children after the administration of single and multiple daily doses of irbesartan (2 mg/kg) up to a maximum daily dose of 150 mg for four weeks.
Maltese: Il-farmakokinetiċi ta' irbesartan kienu kkalkulati fi 23 tifel u tifla bi pressjoni għolja wara l-għoti ta' doża waħda jew aktar kuljum ta' irbesartan (2 mg/kg) sa doża massima ta' kuljum ta' 150 mg għal erba' ġimgħat.
English: As observed for angiotensin converting enzyme inhibitors, irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population (see section 5.1).
Maltese: Kif osservat f'inibituri ta' enzimi li jikkonvertu angiotensin, irbesartan u l-antagonisti ta' angiotensin l-oħrajn huma apparentament inqas effettivi biex iniżżlu l-pressjoni f'nies suwed milli f'dawk mhux suwed, possibilment minħabba li hemm prevelanza ogħla ta' renin baxx fil-popolazzjonijiet ta' razza sewda bi pressjoni għolja (ara sezzjoni 5.1).
English: If you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - aliskiren
Maltese: • jekk qed tieħu xi waħda minn dawn il-mediċini li ġejjin li jintużaw għal kura ta' pressjoni taddemm għolja: - inibitur ta' ACE (pereżempju enalapril, lisinopril, ramipril), b'mod partikulari jekk għandek problemi tal-kliewi relatati mad-dijabete. - aliskiren
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3 % of the patients in the irbesartan group and 26.3 % of the patients in the placebo group.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'insuffiċenzja renali kronika u bi protejnurja li tidher, iperkalimja (≥ 5.5 mEq/L) ġrat f'46.3 % tal-pazjenti fil-grupp ta'
English: The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period.
Maltese: Id-dewmien fil-progressjoni għal protejnurja klinika kien evidenti kmieni sa minn tliet xhur u baqa' għal iktar minn perjodu ta' 2 snin.
English: • Each Irbesartan Teva 150 mg film-coated tablet contains 150 mg irbesartan.
Maltese: • Kull Irbesartan Teva 150 mg pillola miksija b'rita fiha 150 mg irbesartan - Is-sustanzi l-oħra huma:
English: hyperkalaemia Nervous system disorders Common:
Maltese: Disturbi fis-sistema nervuża
English: Irbesartan Teva 300 mg film-coated tablets Irbesartan
Maltese: Irbesartan Teva 300 mg pilloli miksija b'rita Irbesartan
English: B. PACKAGE LEAFLET
Maltese: FOLJA BIL-KALENDARJU
English: The other side of the tablet debossed with number “7464”.
Maltese: In-naħa l-oħra tal-pillola hija intaljata bin-numru “7464”.
English: Non-steroidal anti-inflammatory drugs
Maltese: GĦAMLA FARMAĊEWTIKA
English: The other side of the tablet debossed with number “7466”.
Maltese: In-naħa l-oħra tal-pillola hija intaljata bin-numru “7466”.
English: In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease.
Maltese: F'pazjenti li għandhom dijabete ta' tip 2 u jbatu minn pressjoni għolja, it-terapija mogħtija fil-bidu hija ta' 150 mg ta' irbesartan darba kuljum u li tiġi titrata għal 300 mg darba kuljum bħala l-aħjar doża ta' manteniment ippreferuta għall-kura tal-mard renali.
English: There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Maltese: M'hemmx effett ta' importanza klinika fil-livelli tal-uric acid fisserum jew fit-tnixxija tal-uric acid mal-awrina.
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan (see section 4.4).
Maltese: Kura li ssir qabel b'dożi għoljin ta' dijuretiċi tista' tirriżulta f'nuqqas fil-volum u riskju ta' pressjoni baxxa meta tinbeda l-kura b'irbesartan (ara sezzjoni 4.4).
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Maltese: L-istudju dwar l-“Effetti ta' Irbesartan fuq il-Mikroalbuminuria fil-Pazjenti bi Pressjoni Għolja b'Dijabete Mellitus ta' tip 2 (IRMA 2)” juri li irbesartan 300 mg jittardja l-progressjoni għal protejnurja li tidher f'pazjenti b'mikroalbuminuria.
English: Hyperkalaemia
Maltese: Microcrystalline cellulose
English: As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
Maltese: Bħal fil-każ ta' mediċini simili, każijiet rari ta' reazzjonijiet allerġiċi tal-ġilda (raxx, urtikarja), kif ukoll nefħa lokalizzata tal-wiċċ, ix-xofftejn u /jew l-ilsien ġew rapportati f'pazjenti li kienu qed jieħdu irbesartan.
English: Irbesartan Teva 75 mg film-coated tablets
Maltese: Irbesartan Teva 75 mg pilloli miksija b'rita
English: Other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Maltese: Dijuretiċi u sustanzi oħra li jaġixxu kontra l-pressjoni għolja Sustanzi oħra li jaġixxu kontra l-pressjoni għolja jistgħu jżidu l-effetti ta' tnaqqis fil-pressjoni ta' irbesartan; madankollu irbesartan ingħata mingħajr periklu ma' mediċini oħra ta' kontra l-pressjoni għolja, bħal beta-blockers, imblokkaturi tal-kanali ta' calcium li jaħdmu fit-tul, u dijuretiċi thiazides.
English: Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation.
Maltese: Irbesartan jiġi metabolizzat bil-fwied permezz tal konjugazzjoni ma' glucoronide u ta' ossidazjoni.
English: DATE OF REVISION OF THE TEXT
Maltese: Österreich ratiopharm Arzneimittel Vertriebs
English: The demonstration of renal benefit of irbesartan in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Il-benefiċċju renali muri b'irbesartan f'pazjenti b'dijabete ta' tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma' mediċini oħra ta' kontra l-pressjoni għolja kif meħtieġ, biex jintlaħaq il-livell mixtieq ta' pressjoni (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: See also information under the heading “Do not take Irbesartan Teva”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Irbesartan Teva”
English: The other side of the tablet debossed with number “7465”.
Maltese: In-naħa l-oħra tal-pillola hija intaljata bin-numru “7465”.
English: Each film-coated tablet contains 75 mg irbesartan
Maltese: Kull pillola miksija b'rita fiha 75 mg irbesartan
English: Uncommon: sexual dysfunction
Maltese: Mhux magħruf: disgewsja
English: Each film-coated tablet contains 150 mg irbesartan
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika disponibbli fil-firien uriet li kien hemm eliminazzjoni ta' irbesartan jew il-mataboliti tiegħu fil-ħalib (għal dettalji ara sezzjoni 5.3).
English: Irbesartan Teva 300 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan
Maltese: Kull pillola miksija b'rita fiha 300 mg irbesartan
English: Irbesartan Teva 300 mg film-coated tablets
Maltese: Irbesartan Teva 300 mg pilloli miksija b'rita
English: Irbesartan Teva 150 mg film-coated tablets
Maltese: Irbesartan Teva 150 mg pilloli miksija b'rita
English: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mm Hg in SeSBP and SeDBP compared to +0.1 and -0.3 mm Hg changes respectively in those on all doses of irbesartan (see section 4.2).
Maltese: Fuq il-perjodu tal-ġimagħtejn ta' wara fejn ilpazjenti ġew magħżula b'mod każwali mill-ġdid jew għal prodott mediċinali attiv jew għal plaċebo, ilpazjenti fuq plaċebo kellhom żidiet ta' 2.4 u 2.0 mmHg fis-SeSBP u SeDBP meta mqabbla ma' bidliet rispettivi ta' +0.1 u -0.3 mmHg f'dawk fuq id-dożi kollha ta' irbesartan (ara sezzjoni 4.2).
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Maltese: Żidiet riversibbli tal-konċentrazzjonijiet u tossiċità ta' litju fis-serum ġew irrapportati waqt lamministrazzjoni fl-istes żmien ta' litju ma' inibituri ta' enzimi li jikkonvertu angiotensin.
English: Lithium
Maltese: Anzjani
English: Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e.g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mm Hg or a 10 mm Hg reduction in systolic pressure if baseline was > 160 mm Hg.
Maltese: Il-pazjenti fil-gruppi ta' kura kollha tipikament irċevew bejn 2 u 4 mediċini kontra l-pressjoni għolja (p.e. dijuretiċi, beta blockers, alpha blockers) biex laħqu l-livell imfassal minn qabel ta' pressjoni ta'
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Maltese: Pressjoni għolja renovaskulari Hemm riskju ogħla ta' pressjoni baxxa severa u ta' insuffiċjenza renali meta pazjenti li għandhom stenosi bilaterali ta' l-arterja renali jew stenosi ta' l-arterja b'kilwa waħda taħdem, jiġu kkurati bi prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone.
English: EU/1/09/576/025 50 x 1 tablet (unit dose) EU/1/09/576/026 56 x 1 tablet (unit dose) EU/1/09/576/041 28 tablets (calendar pack)
Maltese: EU/1/09/576/026 56 x pillola 1 (doża waħda)
English: Each film-coated tablet contains 300 mg irbesartan
Maltese: Kull pillola miksija b'rita fiha 300 mg irbesartan.
English: Peak plasma concentrations are attained at 1.5-2 hours after oral administration.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma jintlaħqu wara 1.5-2 sigħat wara t-teħid mill-ħalq.
English: Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Maltese: sogħla, dijarea, indiġestjoni/uġigħ fl-istonku, impotenza (problemi bil-prestazzjoni sesswali),
English: What you need to know before you take Irbesartan Teva Do not take Irbesartan Teva
Maltese: X'għandek tkun taf qabel ma tieħu Irbesartan Teva Tiħux Irbesartan Teva
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Prodotti li jkun fihom aliskiren jew inibituri ta' ACE Dejta minn provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta'
English: EU/1/09/576/038 50 x 1 tablet (unit dose) EU/1/09/576/039 56 x 1 tablet (unit dose) EU/1/09/576/042 28 tablets (calendar pack)
Maltese: EU/1/09/576/039 56 x pillola 1 (doża waħda)
English: The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Maltese: L-effett sabiex titnaqqas il-pressjoni massima tad-demm għandu jintlaħaq fi żmien 4-6 ġimgħat wara lbidu tat-trattament.
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Maltese: Stenosi tal-valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Maltese: Aktar informazzjoni dwar l-interazzjonijiet ta' irbesartan Fi studji kliniċi, il-farmakokinetika ta' irbesartan mhix affettwata minn hydrochlorothiazide.
English: As with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with irbesartan, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Maltese: Bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is-sistema ta' renin-angiotensin-aldosterone, iperkalimja tista' sseħħ waqt il-kura b'irbesartan, speċjalment fil-preżenza t'indeboliment renali, protejnurja ovvja minħabba mard renali dovut għad-dijabete, u/jew insuffiċjenza tal-qalb.
English: The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Maltese: Il-“Prova ta' Irbesartan u n-Nefropatija bid-Diabete (IDNT)” uriet li irbesartan naqqas il-progressjoni tal-mard renali f'pazjenti b'insuffiċjenza renali u b'protejnurja li tidher.
English: Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Maltese: Irbesartan u l-metaboliti tiegħu jiġu eliminati kemm permezz ta' sistemi biljari u dawk renali.
English: The MAH must ensure that the manufacturing processes of the drug substances used for their drug products are reviewed for the potential risk of formation of Nnitrosamines and changed as necessary to minimise nitrosamine contamination as much as possible.
Maltese: Il-MAH għandu jiżgura li l-proċessi ta' manifattura tas-sustanzi mediċinali użati għall-prodotti mediċinali tagħhom jiġu riveduti għar-riskju potenzjali ta' formazzjoni ta' N-nitrosamini u mibdula kif meħtieġ biex titnaqqas kemm jista'
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Maltese: Sakemm terapija b'AIIRA kontinwa mhix meqjusa essenzjali, il-pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta' kontra l-pressjoni għolja li għandhom profil ta' sigurtà stabbilita għal użu waqt tqala.
English: It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Huwa indikat ukoll għat-trattament għal mard renali f'pazjenti adulti li għandhom pressjoni għolja u dijabete mellitus ta' tip 2 bħala parti mill-kura kontra il-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u
English: Not known: impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders
Maltese: Mhux magħruf: funzjoni indebolita tal-kliewi inkluż każijiet ta' indeboliment renali f'pazjenti f'riskju
English: Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Maltese: Mediċini addizzjonali ta' kontra l-pressjoni għolja (li jeskludu inibituri t'ACE, antagonisti tar-riċetturi angiotensin-II u dihydropyridine calcium blockers) ġew miżjuda skont il-ħtieġa biex igħinu fl-ilħuq ta' l-għan talpressjoni.
English: The most likely manifestations of overdose are expected to be hypotension and tachycardia; bradycardia might also occur from overdose.
Maltese: L-iktar manifestazzjonijiet probabbli ta' doża eċċessiva huma mistennija li jkunu pressjoni baxxa, u takikardija; bradikardija tista' wkoll tiġi kkaġunata minn doża eċċessiva.
English: Less than 2 % of the dose is excreted in the urine as unchanged irbesartan.
Maltese: Inqas minn 2 % tad-doża toħroġ fl-awrina bħala irbesartanmhux mibdul.
English: Adolescents and adults
Maltese: Adoloxxenti u adulti
English: • nervousness
Maltese: • nervożiżmu
English: The dose is 0.5 ml.
Maltese: Id-doża hija 0.5 ml.
English: Arthralgia, arthritis
Maltese: Artralġja, artrite
English: Kawasaki syndrome
Maltese: Sindrome ta' Kawasaki
English: Uncommon: anorexia
Maltese: Mhux komuni: anoressija
English: Priorix contains sorbitol.
Maltese: Priorix fih is-sorbitol.
English: • fever higher than 39.5°C
Maltese: • deni ogħla minn 39.5°C
English: Common: rash
Maltese: Komuni: raxx
English: • rash (spots)
Maltese: • raxx (tikek)
English: The vaccine contains 9 mg of sorbitol, see section 4.4.
Maltese: Il-vaċċin fih 9 mg ta' sorbitol, ara sezzjoni 4.4.
English: Humoral or cellular immune deficiency (primary or acquired), including hypogammaglobulinaemia, dysgammaglobulinaemia and AIDS or symptomatic HIV infection or an age-specific CD4+ Tlymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Maltese: Defiċjenza immuni umorali jew ċellulari (primarja jew akkwiżita), fosthom ipogammaglobulinemija, disgammaglobulinemija u AIDS jew infezzjoni sintomatika tal-HIV jew perċentwal ta' limfoċiti CD4+ T speċifiku għall-età fi tfal ta' taħt 12-il xahar: CD4+ <25%; tfal bejn 12-35 xahar: CD4+ < 20%; tfal bejn 36-59 xahar: CD4+ < 15% (ara sezzjoni 4.4).
English: Rare: allergic reactions
Maltese: Rari: reazzjonijiet allerġiċi
English: Uncommon: bronchitis, cough
Maltese: Mhux komuni: bronkite, sogħla
English: Thrombocytopenia, thrombocytopenic purpura
Maltese: Tromboċitopenija, purpura tromboċitopenika
English: WITH 2 SEPARATE NEEDLES: PACK OF 1, 10, 25, 100 WITHOUT NEEDLE: PACK OF 1, 10, 20, 25, 40, 100
Maltese: PAKKETT TA' 1, 10, 20, 25, 40, 100
English: • fever of 38°C or higher
Maltese: • deni ta' 38°C jew ogħla
English: Very common (1/10) Common (1/100 to <1/10) Uncommon (1/1,000 to <1/100) Rare (1/10,000 to <1/1,000)
Maltese: Mhux komuni (1/1,000 sa <1/100) Rari (1/10,000 sa <1/1,000)
English: How to store Priorix
Maltese: Tiħux Priorix
English: • redness, irritation and watering of the eyes (conjunctivitis)
Maltese: • ħmura, irritazzjoni u dmugħ (konġuntivite)
English: • inflammation of the meninges, brain, spinal cord and peripheral nerves, Guillain-Barré syndrome (ascending paralysis up to respiratory paralysis)
Maltese: • infjammazzjoni tal-meninġi, tal-moħħ, tal-korda spinali u tan-nervi periferali, sindrome ta' Guillain-Barré (paraliżi li titla' sa paraliżi respiratorja)
English: PRIORIX can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), Meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations.
Maltese: PRIORIX jista' jingħata fl-istess ħin (iżda f'siti tal-injezzjoni separati) ma' kwalunkwe wieħed millvaċċini monovalenti jew ta' kombinazzjoni li ġejjin [inklużi l-vaċċini eżavalenti (DTPa-HBVIPV/Hib)]: vaċċin tad-difterite-tetnu-sogħla konvulsiva aċellulari (DTPa), vaċċin tal-Haemophilus influenzae tat-tip b (Hib), vaċċin inattivat tal-poljo (IPV), vaċċin tal-epatite B (HBV), vaċċin talepatite A (HAV), vaċċin Meninġokokkali konjugat tas-serotip C (MenC), vaċċin tal-varicella zoster (VZV), vaċċin orali tal-poljo (OPV) u vaċċin pnewmokokkali konjugat 10-valenti skont irrakkomandazzjonijiet lokali.
English: Transverse myelitis, Guillain Barré syndrome, peripheral neuritis, encephalitis* Skin and subcutaneous tissue disorders:
Maltese: Mjelite trasversali, sindrome ta' Guillain Barré, nevrite periferali, enċefalite* Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: The safety and immunogenicity of PRIORIX in adolescents and adults has not been specifically studied in clinical trials.
Maltese: Is-sigurtà u l-immunoġeniċità ta' PRIORIX fl-adoloxxenti u l-adulti ma ġietx studjata speċifikament fi provi kliniċi.
English: The risk of encephalitis following administration of the vaccine is far below the risk of encephalitis caused by natural diseases (measles: 1 in 1000 to 2000 cases; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases).
Maltese: Ir-riskju ta' enċefalite wara l-għoti tal-vaċċin huwa ħafna iżgħar mir-riskju ta' enċefalite kkawżata minn mard naturali (ħosba: 1 f'1000 sa 2000 każ; gattone: 2-4 f'1000 każ; rubella: madwar 1 f'6000 każ).
English: Nervous system disorders: Transverse myelitis, Guillain Barré syndrome, peripheral neuritis, encephalitis*
Maltese: Mjelite trasversali, sindrome ta' Guillain Barré, nevrite periferali, enċefalite*
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL + AMPOULE, PACK OF 1, 10, 20, 25, 40, 100
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KUNJETT + AMPULLA, PAKKETT TA' 1, 10, 20, 25, 40, 100
English: Infections and infestations:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: * Encephalitis has been reported with a frequency below 1 per 10 million doses.
Maltese: * L-enċefalite ġiet irrapportata bi frekwenza ta' inqas minn 1 f'kull 10 miljun doża.
English: Seroconversion rates for measles, mumps and rubella were 92.6%, 91.5% and 100%, respectively.
Maltese: Ir-rati ta' serokonverżjoni għall-ħosba, gattone u rubella kienu 92.6%, 91.5% u 100% rispettivament.
English: For hypersensitivity reactions to egg proteins, see section 4.4.
Maltese: Għar-reazzjonijiet ta' sensittività eċċessiva għall-proteini tal-bajd, ara sezzjoni 4.4.
English: Transmission
Maltese: Trasmissjoni
English: STATEMENT OF ACTIVE SUBSTANCE(S) To be completed nationally
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Blood and lymphatic system disorders: Thrombocytopenia, thrombocytopenic purpura
Maltese: Disturbi tad-demm u tas-sistema limfatika: Tromboċitopenija, purpura tromboċitopenika