FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) is a pro-drug; the active metabolite is the d-alpha-tocopherol.
Maltese: Is-sustanza attiva ta' d-alpha-tocopherol-polyethylene glycol 1000 succinate (tocofersolan) hija pro-drug; il-metabolit attiv huwa d-alpha-tocopherol.
English: Its critical micellar concentration is low (0.04 to 0.06 mmol/l).
Maltese: Il-konċentrazzjoni mixxella kritika hija baxxa (0.04 sa 0.06 mmol/l).
English: Urine represents a minor elimination route of vitamin E (as glucuro-conjugate).
Maltese: L-eliminazzjoni bl-urina huwa passaġġ ta' eliminazzjoni minuri għal vitamina E (bħala glucuro-conjugate).
English: BATCH NUMBER EU/1/09/533/001 10 ml bottle EU/1/09/533/00 2 20 ml bottle EU/1/09/533/003 60 ml bottle
Maltese: EU/1/09/533/001 flixkun ta' 10 ml EU/1/09/533/002 flixkun ta' 20 ml EU/1/09/533/003 flixkun ta' 60 ml
English: Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml.
Maltese: Vedrop fih 0.18 mmoles (4.1 mg) sodju għal kull ml.
English: Vedrop 50 mg/ml oral solution Tocofersolan
Maltese: Vedrop 50 mg/ml soluzzjoni orali Tocofersolan
English: The usual dose is 0.34 ml/kg/day.
Maltese: Id-doża li ġeneralment tingħata hi ta' 0.34 ml/kg/jum.
English: It acts as a free radical chain breaking molecule, stopping the peroxidation of polyunsaturated fatty acids and it is involved in maintaining the stability and integrity of cell membranes.
Maltese: Hi taġixxi bħala molekula li tkisser il-katina radikali libera, twaqqaf il-perossidazzjoni ta' polyunsaturated fatty acids u hi involuta fiż-żamma tal-istabilità u l-integrità ta' membrani ċellulari.
English: Date of latest renewal: 23 April 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 24 ta' Lulju 2009 Data tal-aħħar tiġdid: 23 ta' April 2014
English: Frequencies are defined as: 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), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra kif ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The recommended total daily dose in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis is 0.34 ml/kg/day (17 mg/kg of d-alpha-tocopherol in the form of tocofersolan).
Maltese: Id-doża totali ta' kuljum rakkomandata għal pazjenti pedjatriċi li jbatu minn kolestasi kronika konġenitali jew kolestasi kronika ereditarja hi ta' 0.34 ml/kg/jum (17 mg/kg ta' d-alpha-tocopherol fl-għamla ta' tocofersolan).
English: INFORMATION IN BRAILLE Vedrop 50 mg/ml
Maltese: Vedrop 50 mg/ml
English: Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg)
Maltese: Doża ta' Vedrop (f'ml) = doża ta' d-alpha-tocopherol (f'mg)
English: Absorption of deuterated tocofersolan showed a normal pattern in lipoproteins: alphatocopherol peaked first in chylomicrons, then in very low- density lipoproteins (VLDL) and finally in lowdensity lipoproteins (LDL) and high-density lipoproteins (HDL), and the disappearance portions of the curves paralleled those in control subjects.
Maltese: L-assorbiment ta' tocofersolan dewterat wera skema normali f'lipoproeini: alpha-tocopherol kien l-aktar għoli l-ewwel f'chylomicrons, imbagħad f'lipoproteini ta' densità baxxa ħafna (VLDL) u finalment fi proteini ta' densità baxxa (LDL) u lipoproteini ta' densità għolja (HDL), u l-porzjonijiet li jisparixxu talkurvi kienu paralleli għal dawk f'individwi li ntużaw bħala kontroll.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar issigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: INFORMATION IN BRAILLE Vedrop 50 mg/ml UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Maltese: Vedrop 50 mg/ml IDENTIFIKATUR UNIKU - BARCODE 2D
English: Each ml contains 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) and 0.18 mmoles (4.1 mg) of sodium.
Maltese: Kull ml fih 6 mg sodium methyl parahydroxybenzoate (E219), 4 mg sodium ethyl parahydroxybenzoate (E215) u 0.18 mmoles (4.1 mg) ta' sodium.
English: • Increase of transaminases (liver enzymes)
Maltese: • Żieda f'transaminases (enzimi tal-fwied)
English: Pharmacotherapeutic group: Vitamins, Other plain vitamin preparations; ATC code: A11HA08
Maltese: Vitamini, Preparazzjonijiet tal-vitamini oħra sempliċi; Kodiċi ATC:
English: In a similar study tocofersolan showed a higher bioavailability than a water-miscible reference vitamin E in paediatric patients with chronic cholestasis (n=6), absorption was significantly higher on both plasma concentration maximum increase (p=0.008) and AUC (p=0.0026).
Maltese: Fi studju simili, tocofersolan wera bijodisponibbiltà ogħla mill-vitamina E ta' referenza li titħallat mal-ilma f'pazjenti pedjatriċi b'kolestażi kronika (n=6), l-assorbiment kien ogħla b'mod sinifikanti kemm fiż-żieda massima fil-konċentrazzjoni tal-plażma (p=0.008) kif ukoll fuq l-AUC (p=0.0026).
English: Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215).
Maltese: Eċċipjenti: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215).
English: Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as steroids, antibiotics, antihistamines, cyclosporine, tacrolimus).
Maltese: Minħabba l-inibizzjoni tat-trasportatur ta' p-glycoprotein, tocofersolan jista' wkoll iżid l-assorbiment ta' vitamini oħra li jinħallu fix-xaħam li jittieħdu fl-istess ħin (A, D, E, K) jew dak ta' prodotti mediċinali li huma lipofiliċi ħafna (bħal sterojdi, antibiotiċi, antiħistamini, ċiklosporin, tacrolimus).
English: As data on patients with renal impairment are limited, Vedrop should be administered with caution and under close monitoring of the renal function in patients with renal impairment e.g. dehydrated patients (see section 4.2).
Maltese: Peress li d-dejta fuq pazjenti b'indeboliment tal-kliewi hija limitata, Vedrop għandu jingħata b'attenzjoni u taħt monitoraġġ bir-reqqa tal-funzjoni tal-kliewi f'pazjenti b'indeboliment tal-kliewi eż. pazjenti diżidrati (ara s-sezzjoni 4.2).
English: What Vedrop contains - The active substance is tocofersolan.
Maltese: X'fih Vedrop - Is-sustanza attiva hi tocofersolan.
English: Vitamin E is mainly eliminated in the bile (75%) and stools, either as free tocopherol or as oxidized forms.
Maltese: Il-vitamina E tiġi prinċipalment eliminata mill-bilja tal-marrara (75%) u l-ippurgar, jew bħala tocopherol liberu jew f'għamliet ossidizzati.
English: Uncommon: asthenia, headache
Maltese: Mhux komuni: astenja, uġigħ ta' ras
English: Boxes containing: one 10 ml bottle and one 1 ml oral syringe one 20 ml bottle and one 1 ml oral syringe one 60 ml and one 2 ml oral syringe
Maltese: Kaxxi li fihom : flixkun wieħed ta' 10 ml u siringa orali waħda ta' 1 ml flixkun wieħed ta' 20 ml u siringa orali waħda ta' 1 ml flixkun wieħed ta' 60 ml u siringa orali ta' 2 ml
English: One graduation of the 2-ml oral syringe corresponds to 5 mg of d-alpha-tocopherol in the form of tocofersolan.
Maltese: Gradwazzjoni waħda tas-siringa orali ta' 2 ml tikkorrispondi għal 5 mg ta' d-alpha-tocopherol fil-forma ta' tocofersolan.
English: - The other ingredients are: potassium sorbate, sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) (see end of section 2 for further information on these 2 ingredients), glycerol, disodium phosphate dodecahydrate, concentrated hydrochloric acid, purified water.
Maltese: - Is-sustanzi l-oħra huma: potassium sorbate, sodium methyl parahydroxybenzoate (E219) u sodium ethyl parahydroxybenzoate (E215) (ara tmiem is-sezzjoni 2 għal iktar tagħrif dwar dawn iż-2 ingredjenti), glycerol, disodium phosphate dodecahydrate, hydrochloric acid ikkonċentrat, ilma purifikat.
English: Recordati Rare Diseases Immeuble “le Wilson” 70 avenue du Général de Gaulle 92800 Puteaux
Maltese: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box - 10 ml, 20 ml and 60 ml bottle
Maltese: Kaxxa tal-kartun - flixkun ta' 10 ml, 20 ml u 60 ml
English: Vedrop contains vitamin E (in the form of tocofersolan).
Maltese: Vedrop fih il-vitamina E (fl-għamla ta' tocofersolan).
English: Bottle of 60 ml and 2 ml oral syringe.
Maltese: Flixkun ta' 60 ml u siringa orali ta' 2 ml.
English: The 2 ml oral syringe is graduated from 0.1 to 2 ml in steps of 0.1 ml.
Maltese: Is-siringa orali ta' 2 ml hija ggradwata minn 0.1 sa 2 ml fi skali ta' 0.1 ml.
English: Oral syringes with housing of LDPE and piston of polystyrol.
Maltese: Siringi orali b'reċipjent ta' LDPE u pistun tal-polystyrol.
English: Fat-soluble vitamins (such as vitamin A, D, E or K) or highly fat-soluble medicines (such as corticoids, ciclosporin, tacrolimus, antihistamine).
Maltese: Vitamini li jinħallu fil-grass (bħal vitamina A, D, E jew K) jew mediċini li jinħallu sew fil-grass (bħal kortikosterojdi, ciclosporin, tacrolimus, antiħistamine).
English: It is recommended to monitor the coagulation function when administered with anti-vitamins K treatment (see section 4.4).
Maltese: Huwa rakkomandat li l-funzjoni ta' koagulazzjoni tinżamm taħt sorveljanza meta jingħata ma' kura talantivitamini K (ara s-sezzjoni 4.4).
English: Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients with congenital chronic cholestasis or hereditary chronic cholestasis, from birth (full term newborns) up to 18 years of age.
Maltese: Vedrop hu maħsub għal żbilanċi ta' vitamina E minħabba nuqqas ta' assorbiment xieraq waqt il-proċess diġestiv f'pazjenti pedjatriċi b'kolestasi kronika konġenitali jew b'kolestasi kronika ereditarja, mit-twelid (fi trabi li twieldu fi żmienhom) sa 18-il sena.
English: Each box contains one bottle and one oral syringe (a 1 ml syringe with a 10 ml or 20 ml bottle, a 2 ml syringe with a 60 ml bottle).
Maltese: Kull kaxxa fiha flixkun wieħed u siringa orali waħda (siringa ta' 1 ml ma' flixkun ta' 10 ml jew 20 ml, siringa ta' 2 ml ma' flixkun ta' 60 ml).
English: Large vitamin E doses may cause diarrhoea, abdominal pain, and other gastrointestinal disturbances.
Maltese: Dożi għoljin ta' vitamina E jistgħu jikkawżaw dijarea, uġigħ addominali, u disturbi gastro-intestinali oħra.
English: Bottle of 20 ml and 1 ml oral syringe.
Maltese: Flixkun ta' 20 ml u siringa orali ta' 1 ml.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Bioavailability of vitamin E from Vedrop differs from that of other medicinal products.
Maltese: Il-bijodisponibilità ta' vitamina E minn Vedrop tvarja minn dik ta' prodotti mediċinali oħra.
English: Vedrop should be used with caution and your kidney function closely monitored, because polyethylene glycol, part of the active substance tocofersolan, may damage your kidneys.
Maltese: Vedrop għandu jintuża b'kawtela u l-funzjoni tal-kliewi tiegħek għandu jiġi monitorat mill-qrib, peress li polyethylene glycol, parti mis-sustanza attiva ta' tocofersolan, jista' jagħmel ħsara l-kliewi tiegħek.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Maltese: Reazzjonijiet avversi rapportati huma elenkati hawn isfel skont is-sistema tal-klassifika tal-organi u l-frekwenza.
English: A study in 12 healthy volunteers compared tocofersolan with a water-miscible reference vitamin E after a single oral loading dose of 1200 IU.
Maltese: Studju fi 12-il voluntier b'saħħtu qabbel tocofersolan ma' vitamina E ta' referenza li titħallat mal-ilma wara doża orali waħda ta' kkargar ta' 1200
English: Bottle of 10 ml and 1 ml oral syringe.
Maltese: Flixkun ta' 10 ml u siringa orali ta' 1 ml.
English: NAME OF THE MEDICINAL PRODUCT Vedrop 50 mg/ml oral solution.
Maltese: Vedrop 50 mg/ml soluzzjoni orali.
English: 5 How to store Vedrop
Maltese: Kif taħżen Vedrop
English: Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.
Maltese: Kull flixkun fih 10 ml, 20 ml jew 60 ml ta' soluzzjoni orali.
English: • Asthenia (feeling of weakness)
Maltese: • Astenija (tħossok debboli)
English: Type III brown glass bottle with a child-resistant screw cap of HDPE and LDPE seal.
Maltese: Flixkun tal-ħġieġ kannella ta' Tip III b'għatu tal-kamin reżistenti għat-tfal u b'siġill ta' HDPE u LDPE.
English: Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site conditions
Maltese: Mhux komuni: alopeċja, deni, raxx
English: Not known (frequency cannot be estimated from the available data) • Stomach ache
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 10 ml, 20 ml and 60 ml bottles
Maltese: Tikketta tal-flixkun - Fliexken ta' 10 ml, 20 ml u 60 ml
English: The result is the volume of Vedrop in ml:
Maltese: Sustanzi mhux attivi:
English: Vitamin E is the principal lipo-soluble antioxidant in the organism.
Maltese: Il-vitamina E hija l-antiossidant prinċipali li tinħall fix-xaħam fl-organiżmu.
English: Inform your doctor if you want to breast-feed.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Do not take Vedrop - If you are allergic to vitamin E (d-alpha-tocopherol) or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Vedrop - jekk inti allerġiku għal vitamina E (d-alpha-tocopherol) jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
English: • Do not use this medicine after the expiry date which is stated on the box and the bottle, after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kaxxa u l-flixkun wara EXP.
English: The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml.
Maltese: Is-siringa orali ta' 1 ml hi gradata minn 0.05 sa 1 ml fi skali ta' 0.05 ml. Gradwazzjoni waħda tas-siringa orali ta' 1 ml tikkorrispondi għal 2.5 mg ta' d-alpha-tocopherol fil-forma ta' tocofersolan.
English: NAME OF THE MEDICINAL PRODUCT Vedrop 50 mg/ml oral solution
Maltese: Vedrop 50 mg/ml soluzzjoni orali
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Maltese: Ta' kull sena, simultanjament bis-sottomissjoni ta' rapporti perjodiċi aġġornati dwar is-sigurtà
English: Slightly viscous, pale yellow solution.
Maltese: Soluzzjoni ftit viskuża, ta' lewn safrani ċar.
English: As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR).
Maltese: Peress li dożi kbar ta' vitamina E ġew rapportati li jżidu t-tendenza ta' fsada f'pazjenti li għandhom żbilanċi ta' vitamina K jew dawk li qed jieħdu trattament orali ta' kontra l-vitamina K, huwa għalhekk rakkomandat sabiex li l-ħin ta' prothrombin u l-proporzjon internazzjonali normalizzat (INR) jiġu monitorati.
English: To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) by 50.
Maltese: Sabiex tiġi kkalkulata d-doża ta' Vedrop li trid tingħata, iddividi d-doża preskritta ta' d-alpha-tocopherol (f'mg) b'50.
English: Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
Maltese: Kull ml ta' soluzzjoni fiha 50 mg ta' d-alpha-tocopherol fl-għamla ta' tocofersolan, li tikkorispondi għal 74.5
English: Certain medicines to thin the blood (oral anticoagulants such as warfarin).
Maltese: Ċertu vitamini li jraqqu d-demm (antikoagulanti orali bħal warfarina).
English: EXP
Maltese: Puteaux
English: In case of overdose, a symptomatic treatment should be proposed.
Maltese: F'każ ta' doża eċċessiva, għandha tiġi proposta kura għas-sintomi.
English: Summary of the safety profile The most commonly reported adverse reaction during treatment is diarrhoea.
Maltese: Sommarju tal-profil ta' sikurezza L-iktar reazzjoni avversa rrapportata spiss matul it-trattament hija d-dijarea.
English: Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215), which may cause allergic reactions (possibly delayed).
Maltese: Vedrop fih sodium methyl parahydroxybenzoate (E219) u sodium ethyl parahydroxybenzoate (E215), li jistgħu jikkaġunaw reazzjonijiet allerġiċi (possibilment ittardjati).
English: Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium ethyl parahydroxybenzoate (E215) which may cause allergic reactions (possibly delayed).
Maltese: Vedrop fih sodium methyl parahydroxybenzoate (E219) u sodium ethyl parahydroxybenzoate (E215) li jistgħu jikkaġunaw reazzjonijiet allerġiċi (possibilment ittardjati).
English: diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Maltese: difterja (D), tetnu (T), pertussis (aċellolari, komponent) (PA), epatite B (rDNA) (HBV), poliomelite (inattivat) (IPV) vaċċin (assorbit)
English: • polioviruses (types 1, 2 and 3) that have been inactivated (killed) so that they do not cause any
Maltese: • viruses tal-polio (tipi 1, 2 u 3) li ġew inattivati (maqtula) ħalli ma jmarrdux.
English: The vaccine is ‘adsorbed'.
Maltese: Il-vaċċin huwa ‘assorbit'.
English: This summary was last updated in 07-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 07-2010.
English: Infanrix Penta is a vaccine.
Maltese: Infanrix Penta huwa vaċċin.
English: • surface antigen (proteins from the surface) of the hepatitis B virus;
Maltese: • antiġenu tas-superfiċje (proteina mis-superfiċje) tal-virus tal-epatite B;
English: This document is a summary of the European public assessment report (EPAR) for Infanrix Penta.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Infanrix.
English: What is the risk associated with Infanrix Penta?
Maltese: X'inhu r-riskju assoċjat ma' Infanrix Penta?
English: After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
Maltese: Wara l-vaċċin ‘booster', kien hemm żieda fin-numru ta' trabi b'livelli protettivi ta' antikorpi kontra ssustanzi attivi.
English: Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines.
Maltese: Infanrix Penta huwa kumbinazzjoni ta' komponenti li ilhom disponibbli fl-Unjoni Ewopea (UE) f'vaċċini oħra:. difterite, tetnu, pertussi u epatite B kienu disponibbli f'Infanrix HepB mill-1997 sal-2005, u ddifterite, it-tetnu, il-pertussi, il-viruses tal-polio u l-komponenti Hib jinsabu disponibbli f'vaċċini oħra.
English: The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
Maltese: L-iktar effetti sekondarji komuni b'Infanrix Penta (li dehru f'iktar minn doża waħda minn kull 10 talvaċċin) huma t-telf ta' aptit, deni ta' iktar minn 38ºC, nefħa fis-sit tal-injezzjoni, uġigħ u ħmura fejn tingħata t-tilqima, għejja, biki mhux normali, irritabilità u nuqqas ta' sabar.
English: The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s.a. on 23 October 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Infanrix Penta lil GlaxoSmithKline Biologicals s.a. fit-23 ta' Ottubru 2000.
English: Infanrix Penta is used to protect infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and poliomyelitis (polio).
Maltese: Infanrix Penta jintuża għall-protezzjoni ta' trabi taħt it-tliet snin kontra d-difterite, it-tetnu, il-pertussi (sogħla konvulsiva), l-epatite B u l-poljomjelite (poljo).
English: After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
Maltese: Wara xahar, bejn 86 u 100% ta' trabi żviluppaw livelli protettivi ta' antikorpi kontra s
English: Infanrix Penta has also been studied in nine studies of booster vaccination involving over 4,000 infants, 714 of whom received Infanrix Penta as a booster.
Maltese: Infanrix Penta ġie studjat ukoll f'disa' studji ta' vaċċin ‘booster' li kien jinvolvi iktar minn 4,000 tarbija u tfal żgħar, fejn 714 irċevew Infanrix Penta bħala ‘booster'.
English: • toxoids (chemically weakened toxins) from diphtheria and tetanus; • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Maltese: • partijiet minn Bordetella pertussis (B. pertussis, batterju li jikkawża sogħla konvulsiva);
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: L-antiġeni tal-wiċċ tal-virus tal-epatite B jsiru permezz ta' metodu magħruf bħala ‘teknoloġija rekombinanti tad-DNA': isir minn batterju li jkun irċieva ġene (DNA), li jagħmilha
English: Infanrix Penta is a vaccine, which is available as a suspension for injection.
Maltese: Infanrix Penta huwa vaċċin li jinsab disponibbli bħala sospensjoni għall-injezzjoni.
English: • toxoids from the bacteria that cause diphtheria and tetanus;
Maltese: • tossojdi (tossini dgħajfa kimikament) mid-difterite u t-tetnu;
English: For the full list of all side effects reported with Infanrix Penta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Infanrix Penta, ara l-Fuljett ta' Tagħrif.
English: • toxoids and other proteins purified from B. pertussis;
Maltese: • tossojdi u proteini oħra ppurifikati minn B pertussis;
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Maltese: Is-sistema immunitarja mbagħad tkun tista' tipproduċi antikorpi iktar malajr meta l-persuna tiġi naturalment esposta għall-batterji u l-viruses.
English: The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules.
Maltese: L-istudji involvew iktar minn 10,000 tarbija u tfal żgħar, fejn madwar tliet kwarti minnhom irċevew Infanrix Penta mogħti skond diversi skedi ta' ħin diversi.
English: The CHMP decided that Infanrix Penta's benefits are greater than its risks and recommended that it be
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Infanrix Penta huma akbar mir-riskji tiegħu u rrikkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Other information about Infanrix Penta:
Maltese: Din il-mediċina fiha
English: Infanrix Penta has been studied in 16 studies looking at the first course of vaccination.
Maltese: Infanrix Penta ġie ttesjtjat f'16-il studju li eżaminaw l-ewwel kors tal-vaċċin.